Ethylene Oxide (EtO) Commercial Sterilization Main

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Overview

Introduction
Terms
Facility Details
Room Area
EtO & EG Storage
Sterilizer Chambers
Aeration
APCD Summary
APCD Details
EtO Monitoring
Miscellaneous
Additional Info
Documents
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
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 the Main Questionnaire
This main questionnaire 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.
This main questionnaire contains the following worksheets (you may click on the links below to visit each individual worksheet):
Introduction (this worksheet)		Introduction and instructions for completing and submitting this questionnaire
Terms (link)		Definitions or explanations of certain technical terms that are mentioned throughout this questionnaire
Facility Details (link)		Information about facility registration, ownership, general characteristics, facility-level data, legal documents, etc.
Room Area (link)		Characteristics, inventory of components and control of individual room areas where EtO is used or emitted
EtO & EG Storage (link)		Questions regarding EtO storage in drums and containers, and ethylene glycol (EG) tanks
Sterilizer Chambers (link)		Operation, monitoring and control characteristics of sterilizer chambers
Aeration (link)		Details of aeration equipment
APCD Summary (link)		Information about all air pollution control devices operated by facility
APCD Details (link)		Details regarding air pollution control devices such as scrubbers, catalytic oxidizers, thermal oxidizers, and others
EtO Monitoring (link)		Information about workspace monitoring, personal monitoring, room monitoring, etc. conducted by facility
Miscellaneous (link)		Questions regarding facility's wastewater treatment and other items of EtO commercial sterilization operation
Additional Info (link)		Use this worksheet if you need extra space to provide any additional information requested within this questionnaire
Documents (link)		Designated space to attach documents requested throughout this questionnaire
Certification (link)		Reporter's information and certification for completing and submitting this questionnaire
About the Supplements
There are 3 supplements to this main questionnaire, including: Supplement 1 for Section B, Table 3 Supplement 2 for Section B, Table 4 Supplement 3 for Section I, Table 1 The supplements may be used should you need more space than what is available in the original tables to provide the data requested. If you prefer to fill out any supplement in lieu of the original table, please leave the original table blank in the main questionnaire. Be sure to select “Yes” in the designated cell above each original table where a supplement will be used, and the data fields will be automatically shaded in gray.

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Sheet 2: Terms

Ethylene Oxide (EtO) Commercial Sterilization
CAA Section 114 Information Collection Request (ICR)
Click here to go to "Introduction"
1. Definitions
Term		Definition
Accelerated aeration		Aeration conducted in a heated aeration chamber or cell, not an aeration room, combined with: (1) use of vacuum cycles, and/or (2) high turbulence air created by multiple inlet ports along the length of the aeration cell and multiple outlet points along the top of the cell to provide even distribution of air flow
Aeration cell/chamber		Any vessel that is used to facilitate off-gassing of ethylene oxide at a sterilization facility. If single-item sterilization occurs, the vessel is classified as a sterilization chamber
Aeration room		Any vessel or room that is used to facilitate off-gassing of ethylene oxide at a sterilization facility. If single-item sterilization occurs, the vessel or room is classified as a sterilization chamber
Aeration room area		Any room areas that surround the aeration cell, aeration chamber, or aeration room. For example, aeration room areas may include either the room areas that sterilized materials move through as they are placed in the equipment where aeration occurs, or the room areas that aerated materials move through following the aeration process itself. Note that an "aeration room area" is different from an "aeration room." Aeration room area would include fugitive emissions, while aeration room itself would be a point source of emissions.
Aeration room vent (ARV)		The point(s) through which the evacuation of ethylene oxide-laden air from an aeration room occurs
Balancer/abator system		An air pollution control device (APCD) that consists of a combination of a water balancer and a catalytic oxidizer
Cascading air		Ventilation air removed from one room area or process, with a lower EtO concentration, is vented as the input ventilation air or intake ventilation air directly to another room area or process (e.g., ventilation air from a warehouse is used as intake air to the aeration room or aeration cell). Ventilation air removed from one room area or process must have an equivalent or lower EtO concentration than the room air concentration or process concentration of the room area or process in which it is reused
Chamber exhaust vent (CEV)		The point(s) through which ethylene oxide-laden gas is removed from the sterilization chamber during chamber unloading, following the completion of sterilization and associated air washes. Also known as "back vent"
Combination-chamber sterilizer		Any enclosed vessel in which both the sterilization process and the aeration process occur within the same vessel, e.g., the vessel is filled with ethylene oxide gas or an ethylene oxide/inert gas mixture for the purpose of sterilizing and is followed by off-gassing of ethylene oxide
Dwell period		The length of time that the product is exposed to ethylene oxide in sterilizer chamber for the purpose of sterilizing or fumigating the product
Engineering test		A test that measures the amount of pollutants being emitted, demonstrates the capture efficiency, or determines the destruction or removal efficiency of a control device used to reduce emissions at a facility. This testing is not related to compliance or regulatory requirements
Ethylene oxide (EtO) service		A piece of equipment either contains or contacts ethylene oxide as a liquid or gas at any concentration
Fugitive emissions		Emissions (of ethylene oxide) which are not routed through the existing control equipment
Natural draft opening (NDO)		Any permanent opening in the enclosure that remains open during operation of the facility and is not connected to a duct in which a fan is installed
Non-colocated warehouse/distribution center		A warehouse or distribution center, used to store products that are sterilized with ethylene oxide, that is not part of a facility subject to the ethylene oxide commercial sterilizer rule under 40 CFR part 63, subpart O
Performance test		A test that measures the amount of pollutants being emitted, demonstrates the capture efficiency, or determines the destruction or removal efficiency of a control device used to reduce emissions at a facility. Used to determine a facility’s compliance with an emission limit, capture efficiency, or control efficiency requirement
Research and laboratory facility		Any stationary source whose primary purpose is to conduct research and development into new processes and products, where such source is operated under the close supervision of technically trained personnel and is not engaged in the manufacturer of products for commercial sale in commerce, except in a de minimis manner
Single-item sterilizer		Any enclosed vessel in which sealed pouches containing product and ethylene oxide gas for the purpose of sterilizing are placed, and the ethylene oxide sterilizes and aerates
Sterilization chamber vent (SCV)		The point (prior to vacuum pump) through which the evacuation of ethylene oxide from the sterilizer chamber occurs following sterilization or fumigation, including any subsequent air washes
Sterilization facility		Any stationary source where ethylene oxide is used in the sterilization or fumigation of materials
Sterilization operation		Any time when ethylene oxide is removed from the sterilization chamber through the sterilization chamber vent or the chamber exhaust vent or when ethylene oxide is removed from the aeration room through the aeration room vent
Sterilizer chamber		Any enclosed vessel or room that is filled with ethylene oxide gas, or an ethylene oxide/inert gas mixture, for the purpose of sterilizing and/or fumigating at a sterilization facility. Includes any vessels or rooms where both ethylene oxide sterilization and aeration occur within one chamber
2. Acronyms
Acronym	Term			Acronym	Term
APCD	air pollution control device			ID	identifier
ARV	Aeration room vent			in. H2O	inches of water
CAA	Clean Air Act			kWh	kilowatt hour
CBI	Confidential business information			LEL	lower explosive limit
CEMS	Continuous emissions monitoring system			mg/L	milligrams per liter
CEV	Chamber exhaust vent			NAICS	North American Industrial Classification System
cfm	Cubic feet per minute			NDO	natural draft opening
CFR	Code of Federal Regulations			ppmv	parts per million, volume
EG	ethylene glycol			psig	pressure per square inch, gauge
EIS	Emission Inventory System			QA	quality assurance
EPA	Environmental Protection Agency			QC	quality control
EtO	ethylene oxide			R&D	research and development
ICR	information collection request			SCV	sterilization chamber vent

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Sheet 3: Facility Details

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)

Click here to go to "Introduction"

Click here to go to "Terms"

Click here to go to "Additional Info"

A. Facility Details

Table 1. Facility Information

Field #

A-1

A-2

A-3

A-4

A-5

A-6

A-7

A-8

A-9

A-10

A-11

A-12

Data

Primary NAICS code

EIS ID

Facility name

Facility address

Facility city

Facility state

Facility zip code

Phone number

Number of employees at facility

Operating status in current year

Comments

Operating hours

Is there a plan to expand/modify/close this facility in the near future?

Instruction

Enter the primary NAICS code for the facility 1

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

Select from the dropdown menu. Full-time, part-time, and temporary employees should be counted equally

Select from the dropdown menu in this column

If you choose an option other than "operating" in the previous column, please add a brief comment in this column

Enter the daily operating hours on average of the facility (hours)

Enter the annual operating hours on average of the facility (hours)

Select from the dropdown menu in this column

Provide a short explanation if you select "Yes" on the left

Response

1 For assistance in determining your facility’s NAICS code, see the website for the North American Industry Classification System (NAICS), maintained by the U.S. Census Bureau: https://www.census.gov/eos/www/naics/. (click to visit)

Table 2. Parent Company Information

Field #

A-13

A-14

A-15

A-16

A-17

A-18

A-19

A-20

Data

Parent company

Parent company address

Parent company city

Parent company state

Parent company zip code

Phone number

Is parent company a small business?

Number of employees at parent company

Instruction

Enter parent company name

Enter the street address of parent company verified by U.S. Postal Service (USPS). Do not include P.O. box in this field

Enter parent company city

Select from the dropdown menu in this column

Enter parent company zip code verified by U.S. Postal Service (USPS)

Provide a contact phone number at the parent company

Select from the dropdown menu in this column 2

Select from the dropdown menu in this column

Response

2 To determine the employee threshold for a small business, you may look up the small business size standard using six-digit NAICS codes. The size standards used to define Small Businesses are provided in 13 CFR 121, Small Business Size Regulations. See §121.201, "What size standards has SBA identified by North American Industry Classification System codes?", table “Small Business Size Standards by NAICS Industry”, column “Size standards in number of employees”.

Website for the Small Business Administration: https://www.sba.gov/. (click to visit)

Code of Federal Regulations (CFR), part 121: https://www.ecfr.gov/cgi-bin/text-idx?SID=85df5b1185a8b127a9b324c6583f72c6&mc=true&node=pt13.1.121&rgn=div5. (click to visit)

Table 3. Facility Documents

Field #

A-21

A-22

A-23

A-24

A-25

Data

Facility diagrams

Process flow diagrams

Most recent air permit(s)

Application documents for the most recent air permit(s)

Startup, shutdown and malfunction (SSM) plan

Instruction

Provide diagrams of your facility indicating all rooms, primary EtO emission points (e.g., regulated emission points), and secondary EtO emission points (e.g., fugitive emission points). Ensure that all NDOs are adequately labeled

Provide process flow diagrams of the EtO processes at your facility

Provide the most recent air permit(s) approved for your facility

Provide the application documents for the most recent air permit(s) approved for your facility

Provide the startup, shutdown and malfunction (SSM) plan approved for your facility

Response

See instructions in "Documents" worksheet

See instructions in "Documents" worksheet

See instructions in "Documents" worksheet

See instructions in "Documents" worksheet

See instructions in "Documents" worksheet

Table 4. Facility Buildings

Field #

A-26

A-27

A-28

A-29

A-30

A-31

A-32

A-33

A-34

A-35

Data

Building ID

Building height

Building corner 1

Building corner 2

Building corner 3

Building corner 4 (if any)

Building corner 5 (if any)

Building corner 6 (if any)

Building corner 7 (if any)

Additional comments

Instruction

Enter from permit description, if available. Otherwise, use a unique identifier for each building

Enter the (average) height of the building (feet)

Enter the latitude of this building corner. Specify to the 6th decimal point

Enter the longitude of this building corner. Specify to the 6th decimal point

Enter the latitude of this building corner. Specify to the 6th decimal point

Enter the longitude of this building corner. Specify to the 6th decimal point

Enter the latitude of this building corner. Specify to the 6th decimal point

Enter the longitude of this building corner. Specify to the 6th decimal point

Enter the latitude of this building corner. Specify to the 6th decimal point

Enter the longitude of this building corner. Specify to the 6th decimal point

Enter the latitude of this building corner. Specify to the 6th decimal point

Enter the longitude of this building corner. Specify to the 6th decimal point

Enter the latitude of this building corner. Specify to the 6th decimal point

Enter the longitude of this building corner. Specify to the 6th decimal point

Enter the latitude of this building corner. Specify to the 6th decimal point

Enter the longitude of this building corner. Specify to the 6th decimal point

Enter any additional comments that you may have regarding the information provided in this table about buildings and building corners

Response

Table 5. Facility-level Data

Field #

A-36

A-40

A-41

A-42

A-43

A-44

A-45

A-46

A-47

Data

EtO usage at your facility for the last 5 calendar years

Annual EtO stack emissions of facility for the last 5 years

Annual EtO fugitive emissions of facility for the last 5 years

Documentation for annual EtO emissions calculations

Average annual energy cost of facility operation (include the last 5 years in the average)

Average annual growth rate in revenues from EtO sterilization services for the last 5 years

Size category of facility with respect to hazardous air pollutant (HAP) emissions

As a percentage of all products sterilized at your facility, what is the percentage of products sterilized with EtO?

As a percentage of all products sterilized at your facility, what is the percentage of products sterilized using non-EtO techniques or approaches?

Instruction

Specify the calendar year. Select from the dropdown menu in this column

Enter the corresponding EtO usage in this column (pounds)

Specify the calendar year. Select from the dropdown menu in this column

Enter the value of annual EtO emissions in this column (pounds)

Specify the calendar year. Select from the dropdown menu in this column

Enter the value of annual EtO emissions in this column (pounds)

Provide calculations and supporting documentation for both stack emissions and fugitive emissions, including all emission factors used to determine the annual EtO emissions

Enter the dollar amount in this column

Specify the dollar year in this column

Enter the amount in this column (dollars/year)

Specify the dollar year in this column

Select from the dropdown menu in this column 3

Specify the percentage of products sterilized with EtO, based on all products sterilized at your facility, including both EtO sterilization and non-EtO sterilization. Note that the values entered in this field and Field A-47 should sum to 100% (%)

Specify the percentage of products sterilized with non-EtO approaches, based on all products sterilized at your facility, including both EtO sterilization and non-EtO sterilization. Note that the values entered in this field and Field A-46 should sum to 100% (%)

Response

See instructions in "Documents" worksheet

3 For definitions of major source and area source, see section 112, Hazardous Air Pollutants, paragraph (a)(1) and (2), respectively: https://www3.epa.gov/ttn/atw/112a_def.html. (click to visit)

“Synthetic minor” for HAP means a source that otherwise has the potential to emit HAPs in amounts that are at or above those for major sources of HAP in 40 CFR 63.2, but that have taken a restriction so that its potential to emit (PTE) is less than such amounts for major sources. Such restrictions must be enforceable as a practical matter. See 40 CFR 63.2, Definitions for the definition of federally enforceable: https://www.ecfr.gov/cgi-bin/text-idx?SID=e4db7138e51ff76ffa723d3162b8169d&mc=true&node=se40.11.63_12&rgn=div8. (click to visit)

Table 6. Materials Sterilized with EtO

Field #

A-37

A-38

A-39

A-39.1

A-39.2

Data

Materials sterilized with EtO (e.g., medical products, pharmaceutical products, spices, etc.) at your facility in 2019

Percentage of each type of materials sterilized with EtO in 2019 based on volume of throughput

Percentage of each type of materials sterilized with EtO in 2019 based on dollar amount

Packaging material used for products sterilized with EtO

Pallet material used for products sterilized with EtO

Instruction

List all types of materials sterilized with EtO at your facility in 2019. Enter one type in each cell. If you have more than 10 types, enter "Other materials sterilized with EtO" in Cell C89, then specify. For example: "Other materials sterilized with EtO (Type 10, Type 11, Type 12, etc.)"

Provide the approximate percentage of each type of materials sterilized with EtO in 2019 based on volume of material throughput (%)

Provide the approximate percentage of each type of materials sterilized with EtO in 2019 based on dollar amount (%)

Specify the packaging material used for products sterilized with EtO at your facility

Enter the percent by volume of product sterilized with EtO that uses this packaging material (%)

Specify the pallet materials used in EtO sterilizer chambers

Enter the percent by volume of each type of pallet material used for EtO sterilization (%)

Response

Table 7. Materials Sterilized with Non-EtO Techniques and Approaches

Field #

A-48

A-49

A-50

A-51

Data

Materials sterilized with non-EtO approaches (e.g., medical products, pharmaceutical products, spices, etc.) at your facility in 2019

Percentage of each type of material sterilized with non-EtO approaches in 2019 based on volume of throughput

Percentage of each type of material sterilized with non-EtO approaches in 2019 based on dollar amount

Packaging material used for products sterilized with non-EtO approaches

Instruction

List all types of materials sterilized with non-EtO approaches at your facility in 2019. Enter one type in each cell. If you have more than 10 types, enter "Other materials sterilized with non-EtO" in Cell C105, then specify. For example: "Other materials sterilized with non-EtO (Type 10, Type 11, Type 12, etc.)"

Provide the approximate percentage of each type of material sterilized with non-EtO approaches in 2019 based on volume of material throughput (%)

Provide the approximate percentage of each type of material sterilized with non-EtO approaches in 2019 based on dollar amount (%)

Specify the packaging material used for products sterilized with non-EtO approaches at your facility

Enter the percent by volume of product sterilized with non-EtO approaches that uses this packaging material (%)

Response

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Sheet 4: Room Area

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)

Click here to go to "Introduction"

Click here to go to "Terms"

Click here to go to "Additional Info"

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

Table 1. Characteristics of Room Areas

Field #

B-1

B-2

B-3

B-4

B-5

B-6

B-7

B-8

B-9

B-10

B-11

Data

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

Category of room area

Activities conducted in room area

Floor area

Room height

Temperature

Relative humidity

Pressure drop

Air flow (ventilation)

Air flow (conditioned)

Number of air changes per hour

Instruction

Enter from permit description, if available. Otherwise, use a unique identifier for each room

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 room area)"

Provide a brief explanation of the activities conducted in each room area

(square feet)

(feet)

Enter temperature set point or range for summer in this column (Fahrenheit)

Enter temperature set point or range for winter in this column (Fahrenheit)

Enter temperature set point or range for intermediate seasons in this column (Fahrenheit)

Enter average or range of relative humidity (percent)

Enter the pressure drop across room area (inch H2O)

Specify definition of pressure drop, or locations based on which pressure drop is measured (e.g., farthest point to control device inlet)

Enter average or range of ventilation air flow (actual cubic feet per minute, acfm)

Enter average or range of conditioned air flow (actual cubic feet per minute, acfm)

Enter average or range of number of air changes per hour

Response

Table 2. Natural Draft Openings (NDO)

Field #

B-1

B-12

B-13

B-14

B-15

B-16

B-17

B-18

B-19

B-20

B-21

Data

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

Natural draft opening (NDO) 1 (if any)

Natural draft opening (NDO) 2 (if any)

Natural draft opening (NDO) 3 (if any)

Natural draft opening (NDO) 4 (if any)

Natural draft opening (NDO) 5 (if any)

Natural draft opening (NDO) 6 (if any)

Natural draft opening (NDO) 7 (if any)

Natural draft opening (NDO) 8 (if any)

Natural draft opening (NDO) 9 (if any)

Natural draft opening (NDO) 10 (if any)

Instruction

This column will be auto-populated based on your entries in the previous fields

NDO ID. Enter from permit description, if available. Otherwise, use a unique identifier for each NDO

Type. 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 NDO)"

Orientation. Select from the dropdown menu in this column

Latitude. Specify to the 6th decimal point

Longitude. Specify to the 6th decimal point

Cross-sectional area (square feet)

Height above the ground (feet)

Is air forced out of this NDO? Select from the dropdown menu in this column

Air velocity (feet/minute)

NDO ID. Enter from permit description, if available. Otherwise, use a unique identifier for each NDO

Type. 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 NDO)"

Orientation. Select from the dropdown menu in this column

Latitude. Specify to the 6th decimal point

Longitude. Specify to the 6th decimal point

Cross-sectional area (square feet)

Height above the ground (feet)

Is air forced out of this NDO? Select from the dropdown menu in this column

Air velocity (feet/minute)

NDO ID. Enter from permit description, if available. Otherwise, use a unique identifier for each NDO

Type. 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 NDO)"

Orientation. Select from the dropdown menu in this column

Latitude. Specify to the 6th decimal point

Longitude. Specify to the 6th decimal point

Cross-sectional area (square feet)

Height above the ground (feet)

Is air forced out of this NDO? Select from the dropdown menu in this column

Air velocity (feet/minute)

NDO ID. Enter from permit description, if available. Otherwise, use a unique identifier for each NDO

Type. 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 NDO)"

Orientation. Select from the dropdown menu in this column

Latitude. Specify to the 6th decimal point

Longitude. Specify to the 6th decimal point

Cross-sectional area (square feet)

Height above the ground (feet)

Is air forced out of this NDO? Select from the dropdown menu in this column

Air velocity (feet/minute)

NDO ID. Enter from permit description, if available. Otherwise, use a unique identifier for each NDO

Type. 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 NDO)"

Orientation. Select from the dropdown menu in this column

Latitude. Specify to the 6th decimal point

Longitude. Specify to the 6th decimal point

Cross-sectional area (square feet)

Height above the ground (feet)

Is air forced out of this NDO? Select from the dropdown menu in this column

Air velocity (feet/minute)

NDO ID. Enter from permit description, if available. Otherwise, use a unique identifier for each NDO

Type. 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 NDO)"

Orientation. Select from the dropdown menu in this column

Latitude. Specify to the 6th decimal point

Longitude. Specify to the 6th decimal point

Cross-sectional area (square feet)

Height above the ground (feet)

Is air forced out of this NDO? Select from the dropdown menu in this column

Air velocity (feet/minute)

NDO ID. Enter from permit description, if available. Otherwise, use a unique identifier for each NDO

Type. 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 NDO)"

Orientation. Select from the dropdown menu in this column

Latitude. Specify to the 6th decimal point

Longitude. Specify to the 6th decimal point

Cross-sectional area (square feet)

Height above the ground (feet)

Is air forced out of this NDO? Select from the dropdown menu in this column

Air velocity (feet/minute)

NDO ID. Enter from permit description, if available. Otherwise, use a unique identifier for each NDO

Type. 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 NDO)"

Orientation. Select from the dropdown menu in this column

Latitude. Specify to the 6th decimal point

Longitude. Specify to the 6th decimal point

Cross-sectional area (square feet)

Height above the ground (feet)

Is air forced out of this NDO? Select from the dropdown menu in this column

Air velocity (feet/minute)

NDO ID. Enter from permit description, if available. Otherwise, use a unique identifier for each NDO

Type. 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 NDO)"

Orientation. Select from the dropdown menu in this column

Latitude. Specify to the 6th decimal point

Longitude. Specify to the 6th decimal point

Cross-sectional area (square feet)

Height above the ground (feet)

Is air forced out of this NDO? Select from the dropdown menu in this column

Air velocity (feet/minute)

NDO ID. Enter from permit description, if available. Otherwise, use a unique identifier for each NDO

Type. 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 NDO)"

Orientation. Select from the dropdown menu in this column

Latitude. Specify to the 6th decimal point

Longitude. Specify to the 6th decimal point

Cross-sectional area (square feet)

Height above the ground (feet)

Is air forced out of this NDO? Select from the dropdown menu in this column

Air velocity (feet/minute)

Response

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

Select from the dropdown menu. Scroll up to see options that are auto-populated based on your entries in the previous fields

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

Table 4. Room Area Controls

No (default)

← Switch to "Yes" in Cell F130 on the left if Supplement 2 is used in lieu of this table

If any of your room area is routed to more than 3 APCDs or more than 1 stack, use another row in this table, repeat the room area ID in Field B-1, then fill out the other fields as necessary

*** Note: If you need to enter more than 30 rows of data, please select "Yes" in Cell F120 above, leave this table below BLANK, then fill out SUPPLEMENT 2 to the Section 114 ICR. Refer to the Instructions Document for more details ***

Field #

B-1

B-38

B-39

B-40

B-41

B-42

B-43

B-44

B-45

B-46

B-47

B-48

B-49

B-50

B-51

B-52

B-53

B-54

B-55

B-56

B-57

B-58

B-59

B-60

B-60.1

B-61

B-62

Data

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

Is air from the room area vented to an APCD, used as cascading air, vented to the atmosphere, or handled in any other ways?

APCD 1 for room area

APCD 2 for room area (if any)

APCD 3 for room area (if any)

Material of duct work for room area venting

Total length of duct work for room area venting

Average thickness of duct work for room area venting

Is the cross section of duct work for room area venting circular or rectangular?

Diameter of duct work (For circular duct work only)

Cross-sectional height of duct work (For rectangular duct work only)

Cross-sectional width of duct work (For rectangular duct work only)

Are the dimensions of duct work constant throughout?

Diameter of duct work (For circular duct work only)

Cross-sectional height of duct work (For rectangular duct work only)

Cross-sectional width of duct work (For rectangular duct work only)

Installation year of duct work

Lifetime of duct work

Capital cost of duct work for room area venting (estimated or actual)

Installation cost of duct work for room area venting (estimated or actual)

Room area air used as cascading air for reuse in another room or unit (For cascading only)

Stack ID to which the uncontrolled room area vents (For room area vented to the atmosphere only)

Stack parameter (For room area vented to the atmosphere only)

Stack coordinates (For room area vented to the atmosphere only)

Distance from room area outlet to stack (For room area vented to the atmosphere only)

Other handling of air from room area

Room Air Capture

Instruction

Select from the dropdown menu. Scroll up to see options that are auto-populated based on your entries in the previous fields

Select from the dropdown menu in this column

APCD ID. Enter from permit description, if available. Otherwise, use a unique identifier for each APCD

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 APCD)"

Enter the average air flow routed from the room to this APCD (actual cubic feet per minute, acfm)

APCD ID. Enter from permit description, if available. Otherwise, use a unique identifier for each APCD

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 APCD)"

Enter the average air flow routed from the room to this APCD (actual cubic feet per minute, acfm)

APCD ID. Enter from permit description, if available. Otherwise, use a unique identifier for each APCD

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 APCD)"

Enter the average air flow routed from the room to this APCD (actual cubic feet per minute, acfm)

Specify the material of duct work

Enter the total length of duct work (feet)

Enter the average thickness of duct work (inches)

Select from the dropdown menu in this column

Enter the average diameter of duct work (feet)

Enter the average cross-sectional height of duct work (feet)

Enter the average cross-sectional width of duct work (feet)

Select from the dropdown menu in this column

Enter the maximum diameter of duct work (feet)

Enter the minimum diameter of duct work (feet)

Enter the maximum cross-sectional height of duct work (feet)

Enter the minimum cross-sectional height of duct work (feet)

Enter the maximum cross-sectional width of duct work (feet)

Enter the minimum cross-sectional width of duct work (feet)

Enter the calendar year in which duct work was installed

Enter the expected lifetime of duct work (years)

Enter the dollar amount in this column

Specify the dollar year in this column

Enter the dollar amount in this column

Specify the dollar year in this column

Specify the room area ID or unit ID the air is vented to if the room area air is used as cascading air for reuse in another room or unit (i.e., vented as the input air to another area). If multiple room areas/units are involved, list all the IDs and separate by commas (,). Ensure that any room area ID entered in this field is consistent with your entries in Field B-1 of this worksheet, and that any unit ID is consistent with your entries elsewhere in this questionnaire

Enter from permit description, if available. Otherwise, use a unique identifier for each stack

Enter the stack height (feet)

Enter the stack diameter (feet)

Enter the temperature at stack outlet (Fahrenheit)

Enter the exhaust velocity at stack outlet (feet/second)

Enter the volumetric flow rate for this emission source at stack outlet (cubic feet per minute)

Enter the latitude of stack. Specify to the 6th decimal point

Enter the longitude of stack. Specify to the 6th decimal point

Enter the distance from outlet of the room area to the stack (feet)

Provide a brief description of any air pollution control or handling procedure if air from this room area is not: vented to an APCD; used as cascading air; or vented to the atmosphere

Is there a structure or approach to capture the air emitted from the room area? Select from the dropdown menu in this column

If yes, specify the capture efficiency for this room area (%)

If yes, specify the structure type or approach used to capture the room area (e.g., permanent total enclosure)

If yes, specify the method(s) used to verify the capture efficiency of room air (e.g., Method 204)

Response

---

Sheet 5: EtO & EG Storage

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)

Click here to go to "Introduction"

Click here to go to "Terms"

Click here to go to "Additional Info"

C. EtO Drum and Container Storage

Field #

Data

Instruction

Response

C-0

What companies supply EtO drums or cartridges to your facility? Specify the name and percent (%) by weight for each company

Separate data for each company by commas (,). For example: Company 1 - 70%, Company 2 - 30%

C-1

How many EtO drums and/or containers are typically stored at the facility at once?

C-2

Permitted amount of EtO storage

(pounds)

C-3

Is there a designated area for storing EtO drums and/or containers?

Select from the dropdown menu

C-4

Describe the designated area for EtO drum and/or container storage

C-5

Describe the storage location for full and empty storage media (e.g., indoors in an enclosed room)

C-6

Specify the maximum number of full EtO storage media (e.g., twelve 55-gallon drums) kept at the facility in the last 12 months

C-7

Is the ambient air in the storage areas continually monitored for ethylene oxide?

Select from the dropdown menu

C-8

Describe the make/model and range of the instrumentation used for continuous monitoring of the storage areas

C-9

How often are new drums or containers delivered to facility and empty drums or containers picked up and sent offsite?

C-10

What is the procedure for checking drums or containers before accepting them onsite? If drums or containers do not meet the requirements, what corrective actions are taken, and how many drums or containers per year are the corrective actions performed on?

C-11

Are drums or containers placed next to sterilizer chambers when they are in use?

Select from the dropdown menu

C-12

Describe how EtO is charged to the sterilizer chamber

D. Ethylene Glycol (EG) Tanks

Field #

D-1

D-2

D-3

D-4

D-5

D-6

D-7

D-8

D-9

D-10

D-11

D-12

D-13

D-14

D-15

D-16

D-17

D-18

D-19

D-20

D-21

D-22

D-23

D-24

D-25

D-26

D-27

D-28

D-29

D-30

D-31

Data

Ethylene glycol (EG) tank ID

Material of EG tank

Capacity of EG tank

Throughput of EG tank

Installation year of EG tank

Expected lifetime of EG tank

Capital cost of EG tank

Installation cost of EG tank

Annual cost of EG tank

Is the EG tank routed to any control device?

APCD 1 for EG tank

APCD 2 for EG tank (if any)

Material of duct work for EG tank

Total length of duct work for EG tank

Average thickness of duct work for EG tank

Is the cross section of duct work for EG tank circular or rectangular?

Diameter of duct work (For circular duct work only)

Cross-sectional height of duct work (For rectangular duct work only)

Cross-sectional width of duct work (For rectangular duct work only)

Are the dimensions of duct work constant throughout?

Diameter of duct work (For circular duct work only)

Cross-sectional height of duct work (For rectangular duct work only)

Cross-sectional width of duct work (For rectangular duct work only)

Installation year of duct work

Lifetime of duct work

Capital cost of duct work for EG tank (estimated or actual)

Installation cost of duct work for EG tank (estimated or actual)

Stack ID to which the uncontrolled EG tank vents (For uncontrolled EG tank only)

Stack parameter (For uncontrolled EG tank only)

Stack coordinates (For uncontrolled EG tank only)

Distance from EG tank outlet to stack (For uncontrolled EG tank only)

Instruction

Enter from permit description, if available. Otherwise, use a unique identifier for each EG tank

Specify the material of EG tank

Enter the capacity of EG tank (gallons)

Enter the average daily throughput of EG tank (gallons per day)

Enter the calendar year in which EG tank was installed

Enter the expected lifetime of EG tank (years)

Enter the dollar amount in this column

Specify the dollar year in this column

Enter the dollar amount in this column

Specify the dollar year in this column

Enter the dollar amount in this column

Specify the dollar year in this column

Select from the dropdown menu in this column

APCD ID. Enter from permit description, if available. Otherwise, use a unique identifier for each APCD

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 APCD)"

Enter the average air flow routed from the tank to this APCD (actual cubic feet per minute, acfm)

APCD ID. Enter from permit description, if available. Otherwise, use a unique identifier for each APCD

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 APCD)"

Enter the average air flow routed from the tank to this APCD (actual cubic feet per minute, acfm)

Specify the material of duct work

Enter the total length of duct work (feet)

Enter the average thickness of duct work (inches)

Select from the dropdown menu in this column

Enter the average diameter of duct work (feet)

Enter the average cross-sectional height of duct work (feet)

Enter the average cross-sectional width of duct work (feet)

Select from the dropdown menu in this column

Enter the maximum diameter of duct work (feet)

Enter the minimum diameter of duct work (feet)

Enter the maximum cross-sectional height of duct work (feet)

Enter the minimum cross-sectional height of duct work (feet)

Enter the maximum cross-sectional width of duct work (feet)

Enter the minimum cross-sectional width of duct work (feet)

Enter the calendar year in which duct work was installed

Enter the expected lifetime of duct work (years)

Enter the dollar amount in this column

Specify the dollar year in this column

Enter the dollar amount in this column

Specify the dollar year in this column

Enter from permit description, if available. Otherwise, use a unique identifier for each stack

Enter the stack height (feet)

Enter the stack diameter (feet)

Enter the temperature at stack outlet (Fahrenheit)

Enter the exhaust velocity at stack outlet (feet/second)

Enter the volumetric flow rate for this emission source at stack outlet (cubic feet per minute)

Enter the latitude of stack. Specify to the 6th decimal point

Enter the longitude of stack. Specify to the 6th decimal point

Enter the distance from outlet of the uncontrolled EG tank to the stack (feet)

Response

---

Sheet 6: Sterilizer Chambers

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)

Click here to go to "Introduction"

Click here to go to "Terms"

Click here to go to "Additional Info"

E. Sterilization Chambers

Table 1. Summary for Sterilizer Chambers

Field #

Data

Response

E-0

Enter the total number of sterilizer chambers at your facility

Table 2. Sterilizer Chamber Operation and Monitoring Characteristics

Field #

E-1

B-1

E-2

E-3

E-4

E-5

E-6

E-7

E-8

E-9

E-10

E-11

E-12

E-13

E-14

E-15

E-16

E-17

E-18

E-19

E-20

E-21

E-22

E-23

E-24

E-25

E-26

E-27

E-28

E-29

E-30

E-31

E-32

E-33

E-34

E-35

E-36

E-37

E-38

E-39

E-40

E-41

E-42

E-43

E-44

E-45

E-46

E-47

E-48

E-49

E-50

Data

Sterilizer unit ID

Room area in which sterilizer unit is located

Associated EIS release point ID

Is this an R&D chamber (under the definition of research and laboratory facility)?

Does aeration of the sterilized product occur in the same sterilizer chamber?

Is this a single-item chamber?

Volume of sterilizer chamber

How many cycles per year are conducted in sterilizer chamber in total?

Temperature (For combination sterilizers, enter temperature for sterilization mode only)

Relative humidity

Pressure

Does the sterilizer chamber have positive pressure cycles?

EtO dose per cycle

Number of nitrogen washes per cycle

Nitrogen used for washes during each cycle

Annual cost of nitrogen washes

Number of air washes per cycle

Air used for washes during each cycle

Annual cost of air washes

Average electricity used per gas wash (nitrogen washes and air washes combined)

Annual cost of electricity for gas washes (nitrogen washes and air washes combined)

Are leak checks performed on sterilizer chamber?

Frequency of leak checks for sterilizer chamber

Average length of time to perform a leak check

Leak check procedure(s) for sterilizer chamber

Annual cost of leak checks for sterilizer chamber

Average quantity of leaks identified per year

Repair method/procedure for the leaks identified

Average cost per repair for the leaks identified

Is an EtO concentration monitor used within this sterilizer chamber?

Description of the EtO concentration monitor used within this sterilizer chamber

Installation year of EtO concentration monitor

Expected lifetime of EtO concentration monitor

Capital cost of the EtO concentration monitor used within this sterilizer chamber

Installation cost of the EtO concentration monitor used within this sterilizer chamber

Annual cost of the EtO concentration monitor used within this sterilizer chamber

Standards or work practices followed for the EtO concentration monitor used within this sterilizer chamber

Duration of product dwell time within the chamber at EtO dosing concentration

Total duration of time product stays within the sterilizer chamber before it is moved out

Concentration that EtO is reduced to before moving the product out of this sterilizer chamber

Is EtO from sterilizer captured for re-use?

Is water used during this process?

Amount of water disposed annually

Method of water disposal

Annual costs associated with water disposal

What is the percentage of EtO recovered by this system?

Year in which the EtO recovery system was installed

Expected lifetime of the EtO recovery system

Capital cost of the EtO recovery system used with this sterilizer chamber

Installation cost of the EtO recovery system used with this sterilizer chamber

Annual cost of the EtO recovery system used with this sterilizer chamber (excluding costs associated with wastewater treatment and disposal)

Instruction

Enter from permit description, if available. Otherwise, use a unique identifier for each sterilizer

Select from the dropdown menu. Scroll up to see options that are auto-populated based on your entries in the previous fields

Enter the EIS release point ID associated with the sterilizer unit, if any

Select from the dropdown menu in this column

Select from the dropdown menu in this column (If you select "Yes" for any sterilizer, fill out Table 3 on "Aeration" worksheet)

Select from the dropdown menu in this column

(cubic feet)

Enter the total number of cycles conducted in the sterilizer chamber each year

Enter the average temperature of sterilizer chamber when in operation (Fahrenheit)

Enter the maximum temperature of sterilizer chamber when in operation (Fahrenheit)

Enter the minimum temperature of sterilizer chamber when in operation (Fahrenheit)

Enter the average relative humidity within sterilizer chamber when in operation (percent)

Enter the maximum relative humidity within sterilizer chamber when in operation (percent)

Enter the minimum relative humidity within sterilizer chamber when in operation (percent)

Enter the average pressure within the chamber during EtO dwell period (psig)

Enter the magnitude of vacuum on average that is applied during evacuation (psig)

Select from the dropdown menu in this column

Enter the average EtO dose per cycle (mg/L)

Enter the maximum EtO dose per cycle (mg/L)

Enter the minimum EtO dose per cycle (mg/L)

Enter the average number of nitrogen washes per cycle

Enter the maximum number of nitrogen washes per cycle

Enter the minimum number of nitrogen washes per cycle

Enter the average amount of nitrogen used during each cycle (pounds)

Enter the maximum amount of nitrogen used during each cycle (pounds)

Enter the minimum amount of nitrogen used during each cycle (pounds)

Enter the dollar amount in this column

Specify the dollar year in this column

Enter the average number of air washes per cycle

Enter the maximum number of air washes per cycle

Enter the minimum number of air washes per cycle

Enter the average amount of air used during each cycle (pounds)

Enter the maximum amount of air used during each cycle (pounds)

Enter the minimum amount of air used during each cycle (pounds)

Enter the dollar amount in this column

Specify the dollar year in this column

(kWh)

Enter the dollar amount in this column

Specify the dollar year in this column

Select from the dropdown menu in this column

Specify the frequency of leak checks for sterilizer chamber

Enter average length of time to perform a leak check (minutes)

Provide a brief description of the leak check procedure(s) for sterilizer chamber

Enter the dollar amount in this column

Specify the dollar year in this column

Enter average quantity of leaks found per year

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

Enter the type of EtO concentration monitor

Enter the manufacturer of EtO concentration monitor

Enter the model of EtO concentration monitor

Specify the method of detection of EtO concentration monitor

Enter the value of detection level of EtO concentration monitor

Specify the unit of detection level of EtO concentration monitor

Enter the calendar year in which the EtO concentration monitor was installed

Enter the expected lifetime of the EtO concentration monitor (years)

Enter the dollar amount in this column

Specify the dollar year in this column

Enter the dollar amount in this column

Specify the dollar year in this column

Enter the dollar amount in this column

Specify the dollar year in this column

Provide a brief description of any standards or work practices followed for the EtO concentration monitor used within the chamber

Enter the average duration (hours)

Enter the maximum duration (hours)

Enter the minimum duration (hours)

Enter the average duration (hours)

Enter the maximum duration (hours)

Enter the minimum duration (hours)

Specify the unit of concentration. Select from the dropdown menu in this column

Enter the average concentration that EtO is reduced to (ppm or % LEL)

Enter the maximum concentration that EtO is reduced to (ppm or % LEL)

Enter the minimum concentration that EtO is reduced to (ppm or % LEL)

Select from the dropdown menu in this column

Select from the dropdown menu in this column

(gallons)

Provide a brief description about how water is disposed after being used to capture EtO for re-use

Enter the dollar amount in this column

Specify the dollar year in this column

(percent)

Enter the calendar year

Enter the expected lifetime of the EtO recovery system (years)

Enter the dollar amount in this column

Specify the dollar year in this column

Enter the dollar amount in this column

Specify the dollar year in this column

Enter the dollar amount in this column

Specify the dollar year in this column

Response

Table 3. Control Characteristics for Sterilizer Chambers

Field #

E-1

E-51

E-52

E-53

E-54

E-55

E-56

E-57

E-58

E-59

E-60

E-61

E-62

E-63

E-64

E-65

E-66

E-67

E-68

E-69

E-70

E-71

E-72

E-72.1

E-73

E-74

E-74.1

E-74.2

E-75

E-76

E-77

E-78

E-79

E-80

E-81

E-82

E-83

E-84

E-85

E-86

E-87

E-88

E-89

E-90

E-91

E-92

E-93

E-94

E-95

E-96

E-97

E-98

E-99

E-100

E-101

E-102

E-103

E-104

E-105

E-106

E-107

E-108

E-109

E-110

E-110.1

Data

Sterilizer unit ID

Is the sterilizer chamber vent (SCV) routed to any control device?

APCD 1 for sterilizer chamber vent (SCV)

APCD 2 for sterilizer chamber vent (SCV) (if any)

APCD 3 for sterilizer chamber vent (SCV) (if any)

Material of duct work for sterilizer chamber vent (SCV)

Total length of duct work for sterilizer chamber vent (SCV)

Average thickness of duct work for sterilizer chamber vent (SCV)

Is the cross section of duct work for sterilizer chamber vent (SCV) circular or rectangular?

Diameter of duct work (For circular duct work only)

Cross-sectional height of duct work (For rectangular duct work only)

Cross-sectional width of duct work (For rectangular duct work only)

Are the dimensions of duct work constant throughout?

Diameter of duct work (For circular duct work only)

Cross-sectional height of duct work (For rectangular duct work only)

Cross-sectional width of duct work (For rectangular duct work only)

Installation year of duct work

Lifetime of duct work

Capital cost of duct work for sterilizer chamber vent (SCV) (estimated or actual)

Installation cost of duct work for sterilizer chamber vent (SCV) (estimated or actual)

Stack ID to which the uncontrolled sterilizer chamber vent (SCV) vents (For uncontrolled SCV only)

Stack parameter (For uncontrolled SCV only)

Stack coordinates (For uncontrolled SCV only)

Distance from SCV to stack (For uncontrolled SCV only)

Is there a chamber exhaust vent (CEV)?

Is there a target EtO concentration that is reached before activation of the CEV?

Duration of CEV operation in each sterilization cycle

Average EtO concentration during CEV operation

Is an interlock system present that prevents activation of the CEV and opening of the sterilizer door until a set EtO concentration is reached?

Installation year of interlock system

Expected lifetime of interlock system

Capital cost of interlock system

Annual cost of interlock system

Standards or work practices followed for interlock system

Is the chamber exhaust vent (CEV) routed to any control device?

APCD 1 for chamber exhaust vent (CEV)

APCD 2 for chamber exhaust vent (CEV) (if any)

APCD 3 for chamber exhaust vent (CEV) (if any)

Material of duct work for chamber exhaust vent (CEV)

Total length of duct work for chamber exhaust vent (CEV)

Average thickness of duct work for chamber exhaust vent (CEV)

Is the cross section of duct work for chamber exhaust vent (CEV) circular or rectangular?

Diameter of duct work (For circular duct work only)

Cross-sectional height of duct work (For rectangular duct work only)

Cross-sectional width of duct work (For rectangular duct work only)

Are the dimensions of duct work constant throughout?

Diameter of duct work (For circular duct work only)

Cross-sectional height of duct work (For rectangular duct work only)

Cross-sectional width of duct work (For rectangular duct work only)

Installation year of duct work

Lifetime of duct work

Capital cost of duct work for chamber exhaust vent (CEV) (estimated or actual)

Installation cost of duct work for chamber exhaust vent (CEV) (estimated or actual)

Is any APCD installed solely for the purpose of controlling emissions from the CEV?

If not, was a damper system installed for the purpose of adjusting the flow rate to the control device upon CEV activation?

Year in which the damper system was installed

Expected lifetime of the damper system

Capital cost of the damper system

Installation cost of the damper system

Annual cost of the damper system

APCD installed solely for the purpose of controlling emissions from the CEV

Stack ID to which the uncontrolled chamber exhaust vent (CEV) vents (For uncontrolled CEV only)

Stack parameter (For uncontrolled CEV only)

Stack coordinates (For uncontrolled CEV only)

Distance from CEV to stack (For uncontrolled CEV only)

Instruction

This column will be auto-populated based on your entries in the previous fields

Select from the dropdown menu in this column

APCD ID. Enter from permit description, if available. Otherwise, use a unique identifier for each APCD

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 APCD)"

Enter the average air flow routed from the vent to this APCD (actual cubic feet per minute, acfm)

APCD ID. Enter from permit description, if available. Otherwise, use a unique identifier for each APCD

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 APCD)"

Enter the average air flow routed from the vent to this APCD (actual cubic feet per minute, acfm)

APCD ID. Enter from permit description, if available. Otherwise, use a unique identifier for each APCD

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 APCD)"

Enter the average air flow routed from the vent to this APCD (actual cubic feet per minute, acfm)

Specify the material of duct work

Enter the total length of duct work (feet)

Enter the average thickness of duct work (inches)

Select from the dropdown menu in this column

Enter the average diameter of duct work (feet)

Enter the average cross-sectional height of duct work (feet)

Enter the average cross-sectional width of duct work (feet)

Select from the dropdown menu in this column

Enter the maximum diameter of duct work (feet)

Enter the minimum diameter of duct work (feet)

Enter the maximum cross-sectional height of duct work (feet)

Enter the minimum cross-sectional height of duct work (feet)

Enter the maximum cross-sectional width of duct work (feet)

Enter the minimum cross-sectional width of duct work (feet)

Enter the calendar year in which duct work was installed

Enter the expected lifetime of duct work (years)

Enter the dollar amount in this column

Specify the dollar year in this column

Enter the dollar amount in this column

Specify the dollar year in this column

Enter from permit description, if available. Otherwise, use a unique identifier for each stack

Enter the stack height (feet)

Enter the stack diameter (feet)

Enter the temperature at stack outlet (Fahrenheit)

Enter the exhaust velocity at stack outlet (feet/second)

Enter the volumetric flow rate for this emission source at stack outlet (cubic feet per minute)

Enter the latitude of stack. Specify to the 6th decimal point

Enter the longitude of stack. Specify to the 6th decimal point

Enter the distance from the uncontrolled SCV to the stack (feet)

Select from the dropdown menu in this column

Select from the dropdown menu in this column

Enter the value if you select "Yes" on the left (ppm)

Enter the time that the CEV is in operation for each sterilization cycle (minutes)

Enter the average EtO concentration over the duration of the CEV operation, if available. This should NOT be the EtO concentration at the start of operation (ppm)

Select from the dropdown menu in this column

Enter the calendar year in which the interlock system was installed

Enter the expected lifetime of the interlock system (years)

Enter the dollar amount in this column

Specify the dollar year in this column

Enter the dollar amount in this column

Specify the dollar year in this column

Provide a brief description of any standards or work practices followed for interlock system that prevents activation of the CEV until a set concentration is reached

Select from the dropdown menu in this column

APCD ID. Enter from permit description, if available. Otherwise, use a unique identifier for each APCD

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 APCD)"

Enter the average air flow routed from the vent to this APCD (actual cubic feet per minute, acfm)

APCD ID. Enter from permit description, if available. Otherwise, use a unique identifier for each APCD

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 APCD)"

Enter the average air flow routed from the vent to this APCD (actual cubic feet per minute, acfm)

APCD ID. Enter from permit description, if available. Otherwise, use a unique identifier for each APCD

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 APCD)"

Enter the average air flow routed from the vent to this APCD (actual cubic feet per minute, acfm)

Specify the material of duct work

Enter the total length of duct work (feet)

Enter the average thickness of duct work (inches)

Select from the dropdown menu in this column

Enter the average diameter of duct work (feet)

Enter the average cross-sectional height of duct work (feet)

Enter the average cross-sectional width of duct work (feet)

Select from the dropdown menu in this column

Enter the maximum diameter of duct work (feet)

Enter the minimum diameter of duct work (feet)

Enter the maximum cross-sectional height of duct work (feet)

Enter the minimum cross-sectional height of duct work (feet)

Enter the maximum cross-sectional width of duct work (feet)

Enter the minimum cross-sectional width of duct work (feet)

Enter the calendar year in which duct work was installed

Enter the expected lifetime of duct work (years)

Enter the dollar amount in this column

Specify the dollar year in this column

Enter the dollar amount in this column

Specify the dollar year in this column

Select from the dropdown menu in this column

Select from the dropdown menu in this column

Enter the calendar year

Enter the expected lifetime of the damper system (years)

Enter the dollar amount in this column

Specify the dollar year in this column

Enter the dollar amount in this column

Specify the dollar year in this column

Enter the dollar amount in this column

Specify the dollar year in this column

Specify ID of the APCD installed solely for controlling CEV emissions. If multiple APCDs are involved, list all APCD IDs and separate by commas (,). Ensure that any APCD ID entered in this field is consistent with your entries elsewhere in this questionnaire

Enter from permit description, if available. Otherwise, use a unique identifier for each stack

Enter the stack height (feet)

Enter the stack diameter (feet)

Enter the temperature at stack outlet (Fahrenheit)

Enter the exhaust velocity at stack outlet (feet/second)

Enter the volumetric flow rate for this emission source at stack outlet (cubic feet per minute)

Enter the latitude of stack. Specify to the 6th decimal point

Enter the longitude of stack. Specify to the 6th decimal point

Enter the distance from the uncontrolled CEV to the stack (feet)

Response

Table 4. Control Characteristics for Sterilizer Chambers (continued)

Field #

E-1

E-111

E-112

E-113

E-114

E-115

E-116

E-117

E-118

E-119

E-120

E-121

E-122

E-123

E-124

E-125

E-126

E-127

E-128

E-129

E-130

E-131

E-132

E-132.1

E-133

Data

Sterilizer unit ID

Is there a cover hood or vent over the sterilizer chamber door (e.g., hooded vent above the sterilizer chamber door)?

Is the cover hood or vent routed to any control device?

APCD 1 for cover hood or vent

APCD 2 for cover hood or vent (if any)

Material of duct work for cover hood or vent

Total length of duct work for cover hood or vent

Average thickness of duct work for cover hood or vent

Is the cross section of duct work for the cover hood or vent circular or rectangular?

Diameter of duct work (For circular duct work only)

Cross-sectional height of duct work (For rectangular duct work only)

Cross-sectional width of duct work (For rectangular duct work only)

Are the dimensions of duct work constant throughout?

Diameter of duct work (For circular duct work only)

Cross-sectional height of duct work (For rectangular duct work only)

Cross-sectional width of duct work (For rectangular duct work only)

Installation year of duct work

Lifetime of duct work

Capital cost of duct work for cover hood or vent (estimated or actual)

Installation cost of duct work for cover hood or vent (estimated or actual)

Stack ID to which the cover hood or vent vents (For uncontrolled cover hood or vent only)

Stack parameter (For uncontrolled cover hood or vent only)

Stack coordinates (For uncontrolled cover hood or vent only)

Distance from cover hood or vent to stack (For uncontrolled cover hood or vent only)

Is any SCV or CEV of the sterilizer unit routed to a vacuum pump?

Instruction

This column will be auto-populated based on your entries in the previous fields

Select from the dropdown menu in this column

Select from the dropdown menu in this column

APCD ID. Enter from permit description, if available. Otherwise, use a unique identifier for each APCD

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 APCD)"

Enter the average air flow routed from the cover hood or vent to this APCD (actual cubic feet per minute, acfm)

APCD ID. Enter from permit description, if available. Otherwise, use a unique identifier for each APCD

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 APCD)"

Enter the average air flow routed from the cover hood or vent to this APCD (actual cubic feet per minute, acfm)

Specify the material of duct work

Enter the total length of duct work (feet)

Enter the average thickness of duct work (inches)

Select from the dropdown menu in this column

Enter the average diameter of duct work (feet)

Enter the average cross-sectional height of duct work (feet)

Enter the average cross-sectional width of duct work (feet)

Select from the dropdown menu in this column

Enter the maximum diameter of duct work (feet)

Enter the minimum diameter of duct work (feet)

Enter the maximum cross-sectional height of duct work (feet)

Enter the minimum cross-sectional height of duct work (feet)

Enter the maximum cross-sectional width of duct work (feet)

Enter the minimum cross-sectional width of duct work (feet)

Enter the calendar year in which duct work was installed

Enter the expected lifetime of duct work (years)

Enter the dollar amount in this column

Specify the dollar year in this column

Enter the dollar amount in this column

Specify the dollar year in this column

Enter from permit description, if available. Otherwise, use a unique identifier for each stack

Enter the stack height (feet)

Enter the stack diameter (feet)

Enter the temperature at stack outlet (Fahrenheit)

Enter the exhaust velocity at stack outlet (feet/second)

Enter the volumetric flow rate for this emission source at stack outlet (cubic feet per minute)

Enter the latitude of stack. Specify to the 6th decimal point

Enter the longitude of stack. Specify to the 6th decimal point

Enter the distance from the uncontrolled cover hood or vent to the stack (feet)

Select from the dropdown menu in this column If your answer is "Yes" in any row below, fill out Table 5

Response

Table 5. Vacuum Pumps

Field #

E-134

E-135

E-136

E-137

E-138

E-139

E-140

E-141

E-142

E-143

Data

Unit ID of vacuum pump

Associated sterilizer unit ID(s) and vent(s)

Basic information of vacuum pump

Seal type of vacuum pump

Capacity of vacuum pump

Installation year of vacuum pump

Expected lifetime of the vacuum pump

Capital cost of vacuum pump

Annual cost of vacuum pump

Handling and disposal of water for once-through vacuum pump

Instruction

Enter from permit description, if available. Otherwise, use a unique identifier for each pump

Specify ID of the sterilizer unit associated with this vacuum pump. If multiple sterilizer units are serviced by this vacuum pump, list all sterilizer unit IDs and separate by commas (,). Ensure that any sterilizer unit ID entered in this field is consistent with your entries in Field E-1 of this worksheet. Also specify which vents on the sterilizer unit are routed to the vacuum pump. For example: “SC-1 (SCV, CEV)”

Specify make of pump

Specify model of pump

Specify type of pump. 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 pump)"

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 pump)"

(cubic feet per minute, cfm)

Enter the calendar year in which the vacuum pump was installed

Enter the expected lifetime of the EtO concentration monitor (years)

Enter the dollar amount in this column

Specify the dollar year in this column

Enter the dollar amount in this column

Specify the dollar year in this column

If you selected "once-through" as the type of vacuum pump, provide a brief description about how water is handled and disposed

Response

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Sheet 7: Aeration

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)

Click here to go to "Introduction"

Click here to go to "Terms"

Click here to go to "Additional Info"

F. Aeration

Table 1. Aeration that Occurs in Separate Unit (Aeration Room & Aeration Cell/Chamber)

Field #

F-1

B-1

F-2

F-3

F-4

F-5

F-6

F-7

F-8

F-8.1

F-9

F-10

F-11

F-12

F-13

F-14

F-15

F-16

F-17

F-18

F-19

F-20

F-21

F-22

F-23

F-24

F-25

F-26

F-27

F-28

F-29

F-30

F-31

F-32

F-33

F-34

F-35

F-36

F-37

F-38

F-39

F-40

F-41

F-42

F-42.1

Data

Aeration unit ID

Room area in which aeration unit is located

Associated EIS release point ID

Type of aeration unit

Does the aeration unit use accelerated aeration?

Characteristics of accelerated aeration

Dimensions of aeration cell/chamber (For aeration cell/chamber only. Dimensions of aeration rooms should already have been provided on "Room Area" worksheet)

Temperature

Relative humidity

Average EtO concentration

Pressure (For aeration cell/chamber only)

Pressure drop (For aeration room only)

Facial velocity (For aeration room only)

Location and length of time that sterilized product is placed in aeration room area before being placed in the aeration chamber

Length of time that product is being held in aeration unit before being transferred

Are leak checks performed on aeration unit?

Frequency of leak checks for aeration unit

Average length of time to perform a leak check

Leak check procedure(s) for aeration unit

Annual cost of leak checks for aeration unit

Average quantity of leaks identified per year

Repair method/procedure for leaks identified

Average cost per repair for leaks identified

Is aeration room vent (ARV) routed to any control device?

APCD 1 for aeration room vent (ARV)

APCD 2 for aeration room vent (ARV) (if any)

Material of duct work for aeration room vent (ARV)

Total length of duct work for aeration room vent (ARV)

Average thickness of duct work for aeration room vent (ARV)

Is the cross section of duct work for aeration room vent (ARV) circular or rectangular?

Diameter of duct work (For circular duct work only)

Cross-sectional height of duct work (For rectangular duct work only)

Cross-sectional width of duct work (For rectangular duct work only)

Are the dimensions of duct work constant throughout?

Diameter of duct work (For circular duct work only)

Cross-sectional height of duct work (For rectangular duct work only)

Cross-sectional width of duct work (For rectangular duct work only)

Installation year of duct work

Lifetime of duct work

Capital cost of duct work for aeration room vent (ARV) (estimated or actual)

Installation cost of duct work for aeration room vent (ARV) (estimated or actual)

Stack ID to which the aeration room vents (ARV) is routed to (For uncontrolled ARV only)

Stack parameter (For uncontrolled ARV only)

Stack coordinates (For uncontrolled ARV only)

Distance from ARV to stack (For uncontrolled ARV only)

Instruction

Enter from permit description, if available. Otherwise, use a unique identifier for each aeration unit

Select from the dropdown menu. Scroll up to see options that are auto-populated based on your entries in the previous fields

Enter the EIS release point ID associated with the aeration unit, if any

Select from the dropdown menu in this column

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 equipment)"

Enter the height of aeration unit (feet)

Enter the width of aeration unit (feet)

Enter the length of aeration unit (feet)

Enter the average temperature of aeration room when in operation (Fahrenheit)

Enter the maximum temperature of aeration room when in operation (Fahrenheit)

Enter the minimum temperature of aeration room when in operation (Fahrenheit)

Is a specific humidity needed for aeration? Select from the dropdown menu in this column

If yes, enter the specific humidity that is needed for aeration (percent)

Enter the average EtO concentration in the aeration unit (ppm)

Enter the average pressure within the unit (psig)

Enter the pressure drop across aeration room (inch H2O) (you may choose to fill out either F-10, F-11, or both)

Specify definition of pressure drop, or locations based on which pressure drop is measured (e.g., farthest point to inlet of control device)

Enter the facial velocity in aeration room (feet per minute, fpm) (you may choose to fill out either F-10, F-11, or both)

Provide details on where the sterilized product is placed in the aeration room area (e.g., placed in hallway area outside door of aeration chamber), and the length of time the sterilized product sits in the aeration room area before being placed in the aeration chamber

Enter the average length of time that products are being held in aeration room (hours)

Enter the maximum length of time that products are being held in aeration room (hours)

Enter the minimum length of time that products are being held in aeration room (hours)

Select from the dropdown menu in this column

Specify the frequency of leak checks for sterilizer chamber

Enter average length of time to perform a leak check (minutes)

Provide a brief description of the leak check procedure(s) for aeration unit

Enter the dollar amount in this column

Specify the dollar year in this column

Enter average quantity of leaks found per year

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

APCD ID. Enter from permit description, if available. Otherwise, use a unique identifier for each APCD

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 APCD)"

Enter the average air flow routed from the vent to this APCD (actual cubic feet per minute, acfm)

APCD ID. Enter from permit description, if available. Otherwise, use a unique identifier for each APCD

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 APCD)"

Enter the average air flow routed from the vent to this APCD (actual cubic feet per minute, acfm)

Specify the material of duct work

Enter the total length of duct work (feet)

Enter the average thickness of duct work (feet)

Select from the dropdown menu in this column

Enter the average diameter of duct work (feet)

Enter the average cross-sectional height of duct work (feet)

Enter the average cross-sectional width of duct work (feet)

Select from the dropdown menu in this column

Enter the maximum diameter of duct work (feet)

Enter the minimum diameter of duct work (feet)

Enter the maximum cross-sectional height of duct work (feet)

Enter the minimum cross-sectional height of duct work (feet)

Enter the maximum cross-sectional width of duct work (feet)

Enter the minimum cross-sectional width of duct work (feet)

Enter the calendar year in which duct work was installed

Enter the expected lifetime of duct work (years)

Enter the dollar amount in this column

Specify the dollar year in this column

Enter the dollar amount in this column

Specify the dollar year in this column

Enter from permit description, if available. Otherwise, use a unique identifier for each stack

Enter the stack height (feet)

Enter the stack diameter (feet)

Enter the temperature at stack outlet (Fahrenheit)

Enter the exhaust velocity at stack outlet (feet/second)

Enter the volumetric flow rate for this emission source at stack outlet (cubic feet per minute)

Enter the latitude of stack. Specify to the 6th decimal point

Enter the longitude of stack. Specify to the 6th decimal point

Enter the distance from the uncontrolled ARV to the stack (feet)

Response

Table 2. Aeration that Occurs within Sterilizer Chamber

If no data is auto-populated in Field E-1 of this table, skip to Table 3

Field #

E-1

F-43

F-44

F-45

F-46

Data

Sterilizer unit ID

Temperature

Relative humidity

Pressure

Length of time that products are being held in aeration room before being transferred

Instruction

This column will be auto-populated based on your entries in the previous fields

Enter the average temperature of aeration room when in operation (Fahrenheit)

Enter the maximum temperature of aeration room when in operation (Fahrenheit)

Enter the minimum temperature of aeration room when in operation (Fahrenheit)

Is a specific humidity needed for aeration? Select from the dropdown menu in this column

If yes, enter the specific humidity that is needed for aeration (percent)

Specify pressure condition during aeration process

Enter the average length of time that products are being held in aeration room (hours)

Enter the maximum length of time that products are being held in aeration room (hours)

Enter the minimum length of time that products are being held in aeration room (hours)

Response

Table 3. Movement of Sterilized Products through the Facility

Describe how sterilized product is moved from one area of the facility to another. For each product move through the facility provide, provide details on the following variables: (1) length of time that product sits, (2) where the product is placed, (3) distance product is moved, and (4) note any areas where there is a hood to collect the EO

Field #

Data

Instruction

Response

F-47

From sterilizer chamber to aeration room/chamber

Provide details on where the sterilized product is placed in the sterilizer room area following removal from the chamber, the length of time the sterilized product sits in the sterilizer room area, the distance sterilized product is moved from the sterilizer room area to the aeration room area

F-48

From aeration room/chamber to warehouse area

Provide details on where the sterilized and aerated product is placed after being removed from aeration chamber, length of time the sterilized and aerated product sits after being removed from aeration room, and distance the sterilized and aerated product is moved to warehouse area

F-49

At warehouse area

Provide details on length of time sterilized and aerated product is held in the warehouse before being loaded on truck or other conveyance for shipment offsite

---

Sheet 8: APCD Summary

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)

Click here to go to "Introduction"

Click here to go to "Terms"

Click here to go to "Additional Info"

G. Summary of Air Pollution Control Devices

Table 1. APCD Characteristics

If an APCD exhausts to more than one stack, provide the information requested in Fields G-5 through G-7 for each additional stack on "Additional Info" worksheet (Section M)

Field #

G-1

G-2

G-3

G-4

G-5

G-6

G-7

G-8

G-9

G-10

G-11

G-12

G-13

G-14

G-15

G-16

G-17

G-18

Data

APCD ID

Type of APCD

Associated EIS release point ID

Description of APCD

Stack ID to which the APCD vents

Stack parameter

Stack coordinates

Installation year of APCD

Expected lifetime of APCD

Capital cost of APCD

Installation cost of APCD

Other one-time costs of APCD

Annual monitoring cost of APCD

Annual repair and routine maintenance cost of APCD

Other annual costs of APCD

Is a balancer/snubber system used to moderate EtO concentration before the gas stream enters the control device (e.g., a water bath that absorbs EtO)?

Performance test performed in the last 5 years (if any)

How does the APCD handle variability in flow rate and other relevant parameters?

Instruction

This column will be auto-populated based on your entries in the previous fields

This column will be auto-populated based on your entries in the previous fields

Enter the EIS release point ID associated with this APCD, if any

Specify the manufacturer of APCD

Specify the model of APCD

Enter the value of maximum capable volumetric flow of APCD

Specify the unit of maximum capable volumetric flow of APCD

Enter from permit description, if available. Otherwise, use a unique identifier for each stack

Enter the stack height (feet)

Enter the stack diameter (feet)

Enter the temperature at stack outlet (Fahrenheit)

Enter the exhaust velocity at stack outlet (feet/second)

Enter the volumetric flow rate for this emission source at stack outlet (cubic feet per minute)

Enter the latitude of stack. Specify to the 6th decimal point

Enter the longitude of stack. Specify to the 6th decimal point

Enter the calendar year in which APCD was installed

Enter the expected lifetime of APCD (years)

Enter the dollar amount in this column

Specify the dollar year in this column

Enter the dollar amount in this column

Specify the dollar year in this column

If any, specify other one-time costs of APCD (e.g., programming a data acquisition system)

Enter the total dollar amount in this column

Specify the dollar year in this column

Enter the dollar amount in this column

Specify the dollar year in this column

Enter the dollar amount in this column

Specify the dollar year in this column

Describe other annual costs of APCD

Enter the total dollar amount in this column

Specify the dollar year in this column

Select from the dropdown menu in this column

Specify the dates of any performance test performed for each APCD in the last 5 years (mm/dd/yyyy). If there are multiple dates, separate by commas (,)

Enter the average dollar amount for each performance test in this column

Specify the dollar year in this column

Provide a copy of each performance test performed in the last 5 years in its entirety for each APCD

Provide a brief description about how the APCD handles variability in flow rate and other relevant parameters

Response

See instructions in "Documents" worksheet See instructions in "Documents" worksheet

Table 2. Emissions and CEMS

Field #

G-1

G-2

G-19

G-20

G-21

G-22

G-23

G-24

G-25

G-26

G-27

G-28

Data

APCD ID

Type of APCD

Peak hourly emission rate of APCD

Is any continuous emissions monitoring system (CEMS) used to measure EtO concentration from the APCD?

Description of the CEMS used to measure EtO concentration from the APCD

Installation year of CEMS

Expected lifetime of CEMS

Capital cost of CEMS used to measure EtO concentration from the APCD

Installation cost of CEMS used to measure EtO concentration from the APCD

Annual cost of CEMS used to measure EtO concentration from the APCD

Standards or work practices followed for CEMS used to measure EtO concentration from the APCD

Engineering or non-regulatory emission test performed in the last 5 years (if any)

Instruction

This column will be auto-populated based on your entries in the previous fields

This column will be auto-populated based on your entries in the previous fields

Enter the value of peak hourly emission rate

Specify the unit of peak hourly emission rate

Select from the dropdown menu in this column

Enter the type of CEMS

Enter the manufacturer of CEMS

Enter the model of CEMS

Specify the method of detection of CEMS

Enter the value of detection level of CEMS

Specify the unit of detection level of CEMS

Enter the calendar year in which the CEMS was installed

Enter the expected lifetime of the CEMS (years)

Enter the dollar amount in this column

Specify the dollar year in this column

Enter the dollar amount in this column

Specify the dollar year in this column

Enter the dollar amount in this column

Specify the dollar year in this column

Provide a brief description of any standards or work practices followed for the CEMS used to measure EtO concentration from the APCD

Specify the dates of any engineering or non-regulatory emission test performed for each APCD in the last 5 years (mm/dd/yyyy). If there are multiple dates, separate by commas (,)

Enter the average dollar amount for each engineering emission test in this column

Specify the dollar year in this column

Provide a copy of each engineering or non-regulatory emission test performed in the last 5 years in its entirety for each APCD

Response

See instructions in "Documents" worksheet See instructions in "Documents" worksheet

---

Sheet 9: APCD Details

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)

Click here to go to "Introduction"

Click here to go to "Terms"

Click here to go to "Additional Info"

H. Details of Air Pollution Control Devices

Table 1. Wet Scrubber & Glygen Absorber Unit

Field #

G-1

H-1

H-2

H-3

H-4

H-5

H-6

H-7

H-8

H-9

H-10

H-11

Data

APCD ID

Design and operation specifications

Ethylene glycol (EG) generated annually

Ethylene glycol (EG) tank ID(s) to which wet scrubber/glygen absorber unit feeds

Ethylene glycol (EG) disposal

Annual cost of ethylene glycol (EG) disposal

Process/APCD monitoring plan for wet scrubber/glygen absorber unit

Parameter 1 monitored for wet scrubber/glygen absorber unit

Parameter 2 monitored for wet scrubber/glygen absorber unit (if any)

Parameter 3 monitored for wet scrubber/glygen absorber unit (if any)

Parameter 4 monitored for wet scrubber/glygen absorber unit (if any)

Monitoring records for wet scrubber/glygen absorber unit from the last calendar year

Instruction

This column will be auto-populated based on your entries in the previous fields

Provide a brief description of the design and key operation specifications of the wet scrubber/glygen absorber unit

Enter the amount in this column

Specify the unit in this column

Specify the EG tank ID each wet scrubber/glygen absorber unit feeds EG to, if applicable. If there are multiple EG tanks involved, list all EG tank IDs and separate by commas (,). Ensure that any EG tank ID entered in this field is consistent with your entries in "EtO & EG Storage" worksheet, Field D-1

Provide a brief explanation of how ethylene glycol is disposed (e.g., municipal sewer, industrial sewer, manufacturer pickup, etc.)

Enter the dollar amount in this column

Specify the dollar year in this column

Provide a brief description of the process/APCD monitoring plan for the wet scrubber/glygen absorber unit. Specify if measurements of the gas stream or sorbent material are part of these plans

Name of Parameter 1

Set value of Parameter 1

Unit of Parameter 1

Monitoring frequency of Parameter 1

Explain any corrective actions taken for readings outside the limit(s) for Parameter 1

Name of Parameter 2

Set value of Parameter 2

Unit of Parameter 2

Monitoring frequency of Parameter 2

Explain any corrective actions taken for readings outside the limit(s) for Parameter 2

Name of Parameter 3

Set value of Parameter 3

Unit of Parameter 3

Monitoring frequency of Parameter 3

Explain any corrective actions taken for readings outside the limit(s) for Parameter 3

Name of Parameter 4

Set value of Parameter 4

Unit of Parameter 4

Monitoring frequency of Parameter 4

Explain any corrective actions taken for readings outside the limit(s) for Parameter 4

Provide all monitoring records from the last calendar year

Response

See instructions in "Documents" worksheet

Table 2. Dry-bed Scrubber

Field #

G-1

H-12

H-13

H-14

H-14.1

H-15

H-16

H-16.1

H-16.2

H-17

H-18

H-19

H-20

H-21

H-22

H-23

H-24

H-25

H-26

H-27

H-28

H-29

Data

APCD ID

Design and operation specifications

Type of media/sorbent used

Volume of media/sorbent

Unit cost of media/sorbent

Installation year of current media/sorbent

Expected lifetime of media/sorbent

Initial Capital cost of media/sorbent

Annual Replacement cost of media/sorbent

Can the media/sorbent be regenerated?

Media/sorbent renegeration

Average cost of a media/sorbent regeneration event

Sorbent disposal

Annual cost of sorbent disposal

Is the media/sorbent activity monitored or tested in any way?

Is the media/sorbent change out done based on manufacturer suggestion?

Process/APCD monitoring plan for dry-bed scrubber

Parameter 1 monitored for dry-bed scrubber

Parameter 2 monitored for dry-bed scrubber (if any)

Parameter 3 monitored for dry-bed scrubber (if any)

Parameter 4 monitored for dry-bed scrubber (if any)

Monitoring records for dry-bed scrubber from the last calendar year

Instruction

This column will be auto-populated based on your entries in the previous fields

Provide a brief description of the design and key operation specifications of the dry-bed scrubber

Specify the type of media/sorbent used for the dry-bed scrubber

Enter the volume of media/sorbent used for the dry-bed scrubber (cubic feet)

Enter the dollar amount in this column

Specify the unit of measurement in this column. For example: $ per cubic feet, $ per ton, etc.

Specify the dollar year in this column

Enter the calendar year in which the current media/sorbent was installed

Enter the expected lifetime of the media/sorbent used (years)

Enter the dollar amount in this column

Specify the dollar year in this column

Enter the dollar amount in this column

Specify the dollar year in this column

Select from the dropdown menu in this column

How frequently is the media/sorbent regenerated, if applicable?

What method is used to regenerate the media/sorbent, if applicable?

How many times is the media/sorbent regenerated prior to disposal, if applicable?

To what removal efficiency is the media/sorbent restored after regeneration? (percent)

Enter the dollar amount in this column

Specify the dollar year in this column

Specify how sorbert is disposed (e.g., hazardous waste landfill, MSW landfill, etc.)

Enter the dollar amount in this column

Specify the dollar year in this column

Select from the dropdown menu in this column

If yes, provide a brief description in this column

Select from the dropdown menu in this column If you select "No (double click and type here)", be sure to enter your response between the parentheses Example: "No (your explanation)"

Provide a brief description of the process/APCD monitoring plan for the dry-bed scrubber. Specify if measurements of the gas stream or sorbent material are part of these plans

Name of Parameter 1

Set value of Parameter 1

Unit of Parameter 1

Monitoring frequency of Parameter 1

Explain any corrective actions taken for readings outside the limit(s) for Parameter 1

Name of Parameter 2

Set value of Parameter 2

Unit of Parameter 2

Monitoring frequency of Parameter 2

Explain any corrective actions taken for readings outside the limit(s) for Parameter 2

Name of Parameter 3

Set value of Parameter 3

Unit of Parameter 3

Monitoring frequency of Parameter 3

Explain any corrective actions taken for readings outside the limit(s) for Parameter 3

Name of Parameter 4

Set value of Parameter 4

Unit of Parameter 4

Monitoring frequency of Parameter 4

Explain any corrective actions taken for readings outside the limit(s) for Parameter 4

Provide all monitoring records from the last calendar year

Response

See instructions in "Documents" worksheet

Table 3. Catalytic Oxidizer & Combination Water Balancer/Catalytic Oxidizer

Field #

G-1

H-30

H-31

H-32

H-32.1

H-33

H-34

H-34.1

H-34.2

H-35

H-35.1

H-35.2

H-35.3

H-36

H-37

H-38

H-39

H-40

H-41

H-42

H-43

H-44

H-45

H-46

H-47

H-48

H-49

Data

APCD ID

Design and operation specifications

Type of catalyst

Volume of catalyst

Unit cost of catalyst

Installation year of current catalyst

Expected lifetime of catalyst

Initial Capital cost of catalyst

Annual Replacement cost of catalyst

Operating temperature of catalyst bed

Cost of catalyst replacement

Frequency of catalyst replacement

Average volume of catalyst replacement

Annual natural gas usage to maintain the operating temperature

Annual cost of natural gas used by the catalytic oxidizer or combo water balancer/catalytic oxidizer

Annual cost of electricity used by the catalytic oxidizer or combo water balancer/catalytic oxidizer

Can the catalyst be regenerated?

Catalyst renegeration

Average cost of a catalyst regeneration event

Catalyst disposal

Annual cost of catalyst disposal

Process/APCD monitoring plan for catalytic oxidizer or combo water balancer/catalytic oxidizer

Parameter 1 monitored for catalytic oxidizer & balancer/abator

Parameter 2 monitored for catalytic oxidizer & balancer/abator (if any)

Parameter 3 monitored for catalytic oxidizer & balancer/abator (if any)

Parameter 4 monitored for catalytic oxidizer & balancer/abator (if any)

Monitoring records for catalytic oxidizer & combo water balancer/catalytic oxidizer from the last calendar year

Instruction

This column will be auto-populated based on your entries in the previous fields

Provide a brief description of the design and key operation specifications of the catalytic oxidizer or combo water balancer/catalytic oxidizer

Specify the type of catalyst used in catalytic oxidizer or combo water balancer/catalytic oxidizer

(cubic feet)

Enter the unit cost in this column

Specify the unit of measurement in this column. For example: $ per cubic feet, $ per ton, etc.

Specify the dollar year in this column

Enter the calendar year in which the current catalyst was installed

Enter the expected lifetime of the catalyst used (years)

Enter the dollar amount in this column

Specify the dollar year in this column

Enter the dollar amount in this column

Specify the dollar year in this column

Enter the operating temperature of catalyst bed (Fahrenheit)

Enter the dollar amount in this column

Specify the dollar year in this column

Specify how often on average the catalyst is replaced (years)

Enter the average volume of catalyst replaced every time (cubic feet)

Enter the amount in this column

Specify the unit in this column

Enter the dollar amount in this column

Specify the dollar year in this column

Enter the dollar amount in this column

Specify the dollar year in this column

Select from the dropdown menu in this column

How frequently is the catalyst regenerated, if applicable?

What method is used to regenerate the catalyst, if applicable?

How many times is the catalyst regenerated prior to disposal, if applicable?

To what removal efficiency is the catalyst restored after regeneration? (percent)

Enter the dollar amount in this column

Specify the dollar year in this column

Specify how catalyst is disposed (e.g., hazardous waste landfill, MSW landfill, etc.)

Enter the dollar amount in this column

Specify the dollar year in this column

Provide a brief description of the process/APCD monitoring plan for the catalytic oxidizer or combo water balancer/catalytic oxidizer. Specify if measurements of the gas stream or sorbent material are part of these plans

Name of Parameter 1

Set value of Parameter 1

Unit of Parameter 1

Monitoring frequency of Parameter 1

Explain any corrective actions taken for readings outside the limit(s) for Parameter 1

Name of Parameter 2

Set value of Parameter 2

Unit of Parameter 2

Monitoring frequency of Parameter 2

Explain any corrective actions taken for readings outside the limit(s) for Parameter 2

Name of Parameter 3

Set value of Parameter 3

Unit of Parameter 3

Monitoring frequency of Parameter 3

Explain any corrective actions taken for readings outside the limit(s) for Parameter 3

Name of Parameter 4

Set value of Parameter 4

Unit of Parameter 4

Monitoring frequency of Parameter 4

Explain any corrective actions taken for readings outside the limit(s) for Parameter 4

Provide all monitoring records from the last calendar year

Response

See instructions in "Documents" worksheet

Table 4. Thermal Oxidizer

Field #

G-1

H-50

H-51

H-52

H-53

H-54

H-55

H-56

H-57

H-58

H-59

H-60

Data

APCD ID

Design and operation specifications

Average operating temperature

Operating temperature records for thermal oxidizer from the last calendar year

Annual natural gas usage to maintain the operating temperature

Annual cost of natural gas used to maintain the operating temperature

Process/APCD monitoring plan for thermal oxidizer

Parameter 1 monitored for thermal oxidizer

Parameter 2 monitored for thermal oxidizer (if any)

Parameter 3 monitored for thermal oxidizer (if any)

Parameter 4 monitored for thermal oxidizer (if any)

Monitoring records for thermal oxidizer from the last calendar year

Instruction

This column will be auto-populated based on your entries in the previous fields

Provide a brief description of the design and key operation specifications of the thermal oxidizer

Enter the average operating temperature of thermal oxidizer (Fahrenheit)

Provide the operating temperature records for thermal oxidizer from the last calendar year

Enter the amount in this column

Specify the unit in this column

Enter the dollar amount in this column

Specify the dollar year in this column

Provide a brief description of the process/APCD monitoring plan for the thermal oxidizer. Specify if measurements of the gas stream are part of these plans

Name of Parameter 1

Set value of Parameter 1

Unit of Parameter 1

Monitoring frequency of Parameter 1

Explain any corrective actions taken for readings outside the limit(s) for Parameter 1

Name of Parameter 2

Set value of Parameter 2

Unit of Parameter 2

Monitoring frequency of Parameter 2

Explain any corrective actions taken for readings outside the limit(s) for Parameter 2

Name of Parameter 3

Set value of Parameter 3

Unit of Parameter 3

Monitoring frequency of Parameter 3

Explain any corrective actions taken for readings outside the limit(s) for Parameter 3

Name of Parameter 4

Set value of Parameter 4

Unit of Parameter 4

Monitoring frequency of Parameter 4

Explain any corrective actions taken for readings outside the limit(s) for Parameter 4

Provide all monitoring records from the last calendar year

Response

See instructions in "Documents" worksheet

See instructions in "Documents" worksheet

Table 5. Other APCDs

Field #

G-1

H-61

H-62

H-63

H-64

H-65

H-66

H-67

Data

APCD ID

Design and operation specifications

Process/APCD monitoring plan for APCD

Parameter 1 monitored for APCD

Parameter 2 monitored for APCD (if any)

Parameter 3 monitored for APCD (if any)

Parameter 4 monitored for APCD (if any)

Monitoring records for APCD from the last calendar year

Instruction

This column will be auto-populated based on your entries in the previous fields

Provide a brief description of the design and key operation specifications of the APCD

Provide a brief description of the process/APCD monitoring plan for the APCD. Specify if measurements of the gas stream or sorbent material are part of these plans

Name of Parameter 1

Set value of Parameter 1

Unit of Parameter 1

Monitoring frequency of Parameter 1

Explain any corrective actions taken for readings outside the limit(s) for Parameter 1

Name of Parameter 2

Set value of Parameter 2

Unit of Parameter 2

Monitoring frequency of Parameter 2

Explain any corrective actions taken for readings outside the limit(s) for Parameter 2

Name of Parameter 3

Set value of Parameter 3

Unit of Parameter 3

Monitoring frequency of Parameter 3

Explain any corrective actions taken for readings outside the limit(s) for Parameter 3

Name of Parameter 4

Set value of Parameter 4

Unit of Parameter 4

Monitoring frequency of Parameter 4

Explain any corrective actions taken for readings outside the limit(s) for Parameter 4

Provide all monitoring records from the last calendar year

Response

See instructions in "Documents" worksheet

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Sheet 10: EtO Monitoring

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)

Click here to go to "Introduction"

Click here to go to "Terms"

Click here to go to "Additional Info"

I. EtO Monitoring

Table 1. Personal Monitoring (Badges) for EtO

No (default)

← Switch to "Yes" in Cell F10 on the left if Supplement 3 is used in lieu of this table

List all personal monitoring events during the last 5 years

*** Note: If you need to enter more than 30 rows of data, please select "Yes" in Cell F10 above, leave this table below BLANK, then fill out SUPPLEMENT 3 to the Section 114 ICR. Refer to the Instructions Document for more details ***

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) 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 any room area ID entered in this field is consistent with your entries in "Room Area" tab, Table 1, Field B-1

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 Detection Level in this column

Enter the units of Detection Level 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

Table 2. Room Area Monitoring for EtO

Field #

B-1

I-9

I-9.1

I-9.2

I-10

I-11

I-12

I-13

I-14

I-15

Data

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

Description of room area monitoring

Sampling method of room area monitoring

Level of detection (LOD) as required by the sampling method

EtO concentration of room area where EtO is used or emitted

How many measurement points are there within the room area?

What is the frequency of monitoring at each point within the room area?

Instrument 1

Instrument 2 (if any)

Action levels and SOPs for room area monitoring

Instruction

This column will be auto-populated based on your entries in the previous fields

Provide a brief description of the monitoring procedure for each room

Specify the sampling method used for the room area monitoring

Enter the value of LOD in this column

Enter the unit of LOD in this column

Enter the average EtO concentration (ppmv)

Enter the maximum EtO concentration (ppmv)

Enter the minimum EtO concentration (ppmv)

Enter the amount of measurement points within the room area

Specify the frequency of monitoring at each point within the room area

Specify the instrument used to monitor the room area

Enter the value of detection level of instrument

Specify the unit of detection level of instrument

Specify the instrument used to monitor the room area

Enter the value of detection level of instrument

Specify the unit of detection level of instrument

Provide documents specifying action levels and SOPs for room area monitoring

Response

See instructions in "Documents" worksheet

Table 3. Other Monitoring for EtO

Field #

Data

Response

I-16

Describe any other types of EtO monitoring that have been conducted by the facility, such as near-source, ambient air sampling, or fenceline monitoring efforts

I-17

Describe any dispersion modeling efforts conducted by the facility

I-18

Provide the records for any type of monitoring or modeling efforts noted in I-16 and I-17

See instructions in "Documents" worksheet

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Sheet 11: Miscellaneous

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)

Click here to go to "Introduction"

Click here to go to "Terms"

Click here to go to "Additional Info"

J. Wastewater

Field #

J-1

J-2

J-3

J-4

J-5

J-6

J-7

J-8

J-9

J-10

J-11

J-12

Data

Daily average wastewater flow rate for EtO commercial sterilization activities at the facility

Annual EtO emissions from wastewater at facility for the last 5 years

Average EtO concentration in wastewater when it leaves the vacuum pump or liquid-gas separator

Average EtO concentration in wastewater when collected in a holding tank or basin

Wastewater disposal or treatment for EtO commercial sterilization activities

Annual average cost of wastewater disposal or treatment for EtO commercial sterilization activities

Are there any other processes within the facility that generate EtO-laden wastewater?

Other processes generating EtO-laden wastewater within the facility

Daily average wastewater flow rate for each process other than EtO commercial sterilization

Wastewater disposal or treatment for each process other than EtO commercial sterilization

Annual cost of wastewater disposal or treatment for each process other than EtO commercial sterilization

Annual average wastewater flow for all operations at the facility (includes both EtO commercial sterilization and other activities)

Instruction

(gallons/day)

Enter calendar year in this column

Enter the value of annual EtO emissions in this column (pounds)

(ppmv)

(ppmv)

Briefly specify how wastewater is disposed of or treated for EtO commercial sterilization activities

Enter the dollar amount in this column

Specify the dollar year in this column

Select from the dropdown menu in this column

List all other processes generating EtO-laden wastewater within the facility. Enter one process per each row

(gallons/day)

For each process, briefly specify how wastewater is disposed of or treated

Enter the dollar amount in this column

Specify the dollar year in this column

(gallons/year)

Response

K. Unique Cycles and EtO Reduction

Enter data for each individual category, respectively

If the facility does not plan to re-validate cycles in an effort to reduce EtO use, responses are not required for Fields K-2 through K-4 and K-7 through K-13

Field #

K-1

K-2

K-3

K-4

K-5

K-6

K-7

K-8

K-9

K-10

K-11

K-12

K-13

Data

How many unique cycles are run at this facility?

How many unique cycles have been re-validated thus far?

How many unique cycles does the facility still have left to re-validate

How long will it take to complete re-validation of these cycles?

Cost of validating unique cycles

What is the current average EtO dose among the products?

What is the target average EtO dose?

What is the anticipated average percent change in number of nitrogen washes upon completion of the re-validations?

What is the anticipated average percent change in number of air washes upon completion of the re-validations?

What is the anticipated average percent change in time spent on gas washing upon completion of the re-validations?

What is the anticipated average percent change in dwell period time upon completion of the re-validations?

What is the anticipated average percent change in aeration time upon completion of the re-validations?

What are the anticipated annual cost savings from reduced EtO use?

Instruction

Enter the amount of unique cycles

Enter the amount of unique cycles

Enter the amount of unique cycles

Enter the value in this column

Specify the unit in this column

Provide information on the cost to validate a sterilization cycle, including: (1) hours of time for R&D engineers, operators, technicians, etc. to complete the sterilization cycle runs, compile the reports and file with the FDA; (2) costs for laboratory analyses; and (3) information on the length of time from start to finish (weeks) required to complete validation for a sterilization cycle

(mg/L)

(mg/L)

(percent)

(percent)

(percent)

(percent)

(percent)

Enter the dollar amount in this column

Specify the dollar year in this column

Response for all products in total

Response for 510(k) products (Class I and Class II devices)

Response for Pre-Market Approval (PMA) products (Class III devices)

L. Other Questions regarding EtO Commercial Sterilization

Table 1. EtO and Facility Operation

Field #

Data

Instruction

Response

L-1

How is EtO handled during malfunction events of process equipment (vented, held within chamber/room, etc)?

L-2

How is EtO handled during malfunction events of APCD (vented, held within chamber/room, etc)? Also provide standard operation practices or protocol in the event of a power outages

L-3

Provide documentation of any studies done on quantifying EtO residuals in your products

See instructions in "Documents" worksheet

L-4

Are there generators on site to keep facility running in the event of a power outage?

Select from the dropdown menu

L-5

Provide percent emission reduction, associated costs, and description of QA/QC for voluntary measures

L-6

Is the facility operating at full capacity or can current capacity increase to accommodate higher volumes of product? If not operating at full capacity, provide estimate of feasible increase in capacity as a percentage (%) of current output

L-7

Provide any process and instrumentation diagrams (P&ID) that are not included in other documents requested

See instructions in "Documents" worksheet

Table 2. Standalone Non-Colocated Warehouse, Distribution Center, or Enclosed Building for Sterilized Products

Field #

L-8

L-9

L-10

L-11

Data

Offsite locations sterilized products are sent

Are any of the products sterilized in your facility shipped to a separate standalone non-colocated warehouse, distribution center, or enclosed building that is not currently subject to §63.360 and where sterilized product is stored for a time period longer than 24 hours prior to re-shipment?

Information on the standalone non-colocated warehouse, distribution center, or enclosed building that is not currently subject to §63.360 and where sterilized product is stored for a time period longer than 24 hours prior to re-shipment

How long are the products sterilized in your facility generally held in the separate standalone non-colocated warehouse, distribution center, or enclosed building listed in Field L-10 on the left?

Instruction

When the products sterilized in your facility are moved offsite, where are they sent to (e.g., standalone non-colocated warehouse, manufacturer, hospital, etc.)?

Enter the percent by weight of the sterilized products sent to each type of offsite location (%)

Select from the dropdown menu in Cell F56 below

Name of the standalone non-colocated warehouse, distribution center, or enclosed building

Street address verified by U.S. Postal Service (USPS). Do not include P.O. box in this field

City

State. Select from the dropdown menu in this column

Zip code verified by U.S. Postal Service (USPS)

(Days)

Response

Table 3. Alternative Sterilization

Field #

L-12

L-13

Data

Alternative sterilization method

Details of alternative sterilization method

Instruction

Specify the alternative sterilization method(s) that can be applied to each product class, if any. Select from the dropdown menu. If you select "Other (double click and type here)", be sure to enter your response between the parentheses Example: "Other (your alternative)"

Percentage of this product that may be sterilized with the alternative method (%)

Time needed to switch from EtO to the alternative (months)

Capital cost to switch from EtO to the alternative. Enter the dollar amount in this column

Capital cost to switch from EtO to the alternative. Specify the dollar year in this column

Annual cost to switch from EtO to the alternative. Enter the dollar amount in this column

Annual cost to switch from EtO to the alternative. Specify the dollar year in this column

Change in annual cost with respect to using EtO. If alternative costs are less than EtO, please enter a negative value. Enter the dollar amount in this column

Change in annual cost with respect to using EtO. Specify the dollar year in this column

Response for 510(k) products (Class I and Class II devices)

Response for Pre-Market Approval (PMA) products (Class III devices)

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Sheet 12: Additional Info

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)

Click here to go to "Introduction"

Click here to go to "Terms"

M. Additional Information

If you need extra space to provide additional information requested throughout this questionnaire, fill out this table below unless you may use any of the supplements to the Section 114 ICR. For each entry, specify the worksheet and field number to which your data refers

Worksheet

Field #

Response

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Sheet 13: Documents

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 CBI files in the CBI version After creating the non-CBI version, remove all the CBI documents and preserve only the non-CBI documents. Do not change the total number of CBI vs. non-CBI documents entered in Column G and Column H

EIS ID (Auto-populated)

CAA Section 114 Information Collection Request (ICR)

Click here to go to "Introduction"

Click here to go to "Terms"

Click here to go to "Additional Info"

N. Documents

The documents requested throughout this questionnaire and the associated field numbers and descriptions are summarized in this table below. Please refer to Sections V of the Instructions Document and properly name your documents first before proceeding. Specify in Column G and Column H of the table below the total number of CBI and non-CBI documents of each category that you intend to submit to the EPA. Do not change these quantities between the CBI and non-CBI version of your response. Option 1 (recommended for submitting more than 12 documents in any category): Submit your documents as standalone PDF files via email (non-CBI documents only) or a media (e.g., thumb drive, CD or DVD) following Section VI of the Instructions Document; Option 2: Add your documents to the table below as attachments. Please attach only 1 document to each cell (maximum of 12 documents in each category). If your documents attached here contain CBI, shade in red all cells containing CBI documents, and select "Yes" in Cell N2 of this worksheet. Instructions on how to attach documents are provided in Cell O10 on the right. If you choose Option 2, make sure that the CBI version of your response contains all the CBI and non-CBI documents, while the non-CBI version contains only the non-CBI documents you would like to submit to the EPA.

Steps to attach documents to the table below (1) Click on the field to attach files; (2) Go to the Insert tab → Text, click Object; (3) In the Object dialog box, click the Create from File tab; (4) Click Browse, and select the file you want to insert; (5) Select the Display as Icon check box, then click OK. Repeat the above steps to attach any additional files

Field #

Data

Instruction

Total Quantity of CBI Documents

Total Quantity of non-CBI Documents

Documents

A-21

Facility diagrams

Provide diagrams of your facility indicating all rooms, primary EtO emission points (e.g., regulated emission points), and secondary EtO emission points (e.g., fugitive emission points)

A-22

Process flow diagrams

Provide process flow diagrams of the EtO processes at your facility

A-23

Most recent air permit(s)

Provide the most recent air permit(s) approved for your facility

A-24

Application documents for the most recent air permit(s)

Provide the application documents for the most recent air permit(s) approved for your facility

A-25

Startup, shutdown and malfunction (SSM) plan

Provide the startup, shutdown and malfunction (SSM) plan approved for your facility

A-42

Documentation for annual emissions calculations

Provide calculations and supporting documentation for all emission factors used to determine the annual emissions

G-17

Performance test performed in the last 5 years (if any)

Provide a copy of each performance test performed in the last 5 years in its entirety for each APCD

G-28

Engineering emission test performed in the last 5 years (if any)

Provide a copy of each engineering emission test performed in the last 5 years in its entirety for each APCD

H-11

Monitoring records for wet scrubber from the last calendar year

Provide all monitoring records from the last calendar year

H-29

Monitoring records for dry-bed scrubber from the last calendar year

Provide all monitoring records from the last calendar year

H-49

Monitoring records for catalytic oxidizer & combo water balancer/catalytic oxidizer from the last calendar year

Provide all monitoring records from the last calendar year

H-52

Operating temperature records for thermal oxidizer from the last calendar year

Provide the operating temperature records for thermal oxidizer from the last calendar year

H-60

Monitoring records for thermal oxidizer from the last calendar year

Provide all monitoring records from the last calendar year

H-67

Monitoring records for APCD from the last calendar year

Provide all monitoring records from the last calendar year

I-15

Action levels and SOPs for room area monitoring

Provide documents specifying action levels and SOPs for room area monitoring

I-18

Provide the records for any type of monitoring efforts you have mentioned in Fields I-16 and I-17

L-3

Provide documentation of any studies done on quantifying EtO residuals in your products

L-7

Provide any process and instrumentation diagrams (P&ID) that are not included in other documents requested

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Sheet 14: 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