SUPPORTING STATEMENT

ENVIRONMENTAL PROTECTION AGENCY

NESHAP for Commercial Ethylene Oxide Sterilization and Fumigation Operations 

(40 CFR Part 63, Subpart O) (Renewal)

1. Identification of the Information Collection

1(a) Title of the Information Collection

NESHAP for Commercial Ethylene Oxide Sterilization and Fumigation Operations (40 CFR Part 

63, Subpart O) (Renewal), EPA ICR Number 1666.08, OMB Control Number 2060-0283

1(b) Short Characterization/Abstract

The National Emission Standards for Hazardous Air Pollutants (NESHAP) for 

Commercial Ethylene Oxide Sterilization and Fumigation Operations (40 CFR part 63, 

subpart O) were proposed on March 7, 1994, and promulgated on December 6, 1994. These 

regulations apply to new and existing commercial ethylene oxide (EO) sterilization and 

fumigation facilities using 1 ton of EO (as defined in 40 CFR section 63.361) after December 

6, 1994. This information is being collected to assure compliance with part 63, subpart O.

In general, all NESHAP standards require initial notifications, performance tests, and 

periodic reports. Owners or operators are also required to maintain records of the occurrence and 

duration of any startup, shutdown, or malfunction in the operation of an affected facility, or any

period during which the monitoring system is inoperative. These notifications, reports, and 

records are essential in determining compliance, and are required of all sources subject to 

NESHAP.

Any owner or operator subject to the provisions of this part shall maintain a file of these 

measurements, and retain the file for at least five years following the date of such measurements, 

maintenance reports, and records. All reports are sent to the delegated state or local authority. In 

the event that there is no such delegated authority, the reports are sent directly to the United States 

Environmental Protection Agency (EPA) regional office.

Approximately 119 sources are currently subject to the regulation, and it is estimated that 

there will be two additional sources per year subject to the regulation over the next three years. 

This information was provided by the Ethylene Oxide Sterilization Association, which represents 

the vast majority of facilities subject to this standard, was consulted to determine these estimates.

The previous ICR had the following Terms of Clearance (TOC):

The assumptions underlying the estimates of industry and agency

burden and costs of the collection should be updated in the next 

renewal.
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EPA has addressed each item of concern in the TOC by updating respondent assumptions 

using September 2009 labor rates from the United States Department of Labor, Bureau of Labor 

Statistics. Agency assumptions were updated using the Office of Personnel Management (OPM), 

2010 General Schedule for Agency labor. Respondent and Agency cost assumptions are provided 

in Sections 6(b)(i) and 6(c) of this document. 

There are 119 commercial ethylene oxide sterilization and fumigation facilities in the 

United States, which are all publicly owned and operated by the ethylene oxide sterilization and 

fumigation industry. None of the 119 facilities in the United States are owned by either state, local, 

tribal or the Federal government, they are all owned and operated solely by privately owned

for-profit businesses, thus, the Federal government burden does not include work performed by

federal employees only work performed by contractors.

The burden to the “Affected Public” may be found below in Table 1: Annual Respondent 

Burden and Cost - NESHAP for Commercial Ethylene Oxide Sterilization and Fumigation 

Operations (40 CFR part 63, subpart O) (Renewal). The burden to the “Federal government” is 

attributed entirely to work performed by Federal employees or government contractors; this 

burden may be found below in Table 2: Average Annual EPA Burden - NESHAP for Commercial 

Ethylene Oxide Sterilization and Fumigation Operations (40 CFR part 63, subpart O) (Renewal).

2. Need for and Use of the Collection

2(a) Need/Authority for the Collection

The EPA is charged under section 112 of the Clean Air Act, as amended, to establish 

standards of performance for each category or subcategory of major sources and area sources of 

hazardous air pollutants (HAP). These standards are applicable to new or existing sources of HAP 

and shall require the maximum degree of emission reduction. In addition, section 114(a) states 

that the Administrator may require any owner or operator subject to any requirement of this Act to:

(A) Establish and maintain such records; (B) make such reports; 

(C) install, use, and maintain such monitoring equipment, and use 

such audit procedures, or methods; (D) sample such emissions (in 

accordance with such procedures or methods, at such locations, at 

such intervals, during such periods, and in such manner as the 

Administrator shall prescribe); (E) keep records on control 

equipment parameters, production variables or other indirect data 

when direct monitoring of emissions is impractical; (F) submit 

compliance certifications in accordance with Section 114(a)(3); 

and (G) provide such other information as the Administrator may

reasonably require.

In the Administrator's judgment, EO emissions from sterilization facilities cause or 

contribute to air pollution that may reasonably be anticipated to endanger public health or welfare. 

Therefore, the NESHAP was promulgated for this source category at 40 CFR part 63, subpart O.
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2(b) Practical Utility/Users of the Data

The control of EO emissions from sterilization facilities requires not only the installation of 

properly designed equipment, but also the operation and maintenance of that equipment. 

Emissions of EO from sterilization facilities are the result of operation of sterilization chambers. 

These standards are achieved by the reduction of EO emissions using acid-water scrubbers or 

catalytic/thermal oxidizers.

The notifications required in the applicable regulations are used to inform the Agency or 

delegated authority when a source becomes subject to the requirements of the regulations. The 

reviewing authority may then inspect the source to check if the pollution control devices are 

properly installed and operated, that leaks are being detected and repaired, and that the regulations 

are being met. The semiannual reports are used for problem identification, as a check on source 

operation and maintenance, and for compliance determinations.

The information generated by the monitoring, recordkeeping and reporting requirement 

described in this ICR is used by the Agency to ensure that facilities affected by the NESHAP 

continue to operate the control equipment in compliance with the regulation. Adequate 

monitoring, recordkeeping, and reporting are necessary to ensure compliance with the applicable 

regulations, as required by the Clean Air Act. The information collected from recordkeeping and 

reporting requirements is also used for targeting inspections, and is of sufficient quality to be used 

as evidence in court.

3. Non-duplication, Consultations, and Other Collection Criteria

The requested recordkeeping and reporting are required under 40 CFR part 63, subpart O.

3(a) Non-duplication

If the subject standards have not been delegated, the information is sent directly to the 

appropriate EPA regional office. Otherwise, the information is sent directly to the delegated state 

or local agency. If a state or local agency has adopted their own similar standards to implement the 

Federal standards, a copy of the report submitted to the state or local agency can be sent to the 

Administrator in lieu of the report required by the Federal standards. Therefore, no duplication 

exists.

3(b) Public Notice Required Prior to ICR Submission to OMB

An announcement of a public comment period for the renewal of this ICR was published in 

the Federal Register (74 FR 32581) on July 8, 2009. No comments were received on the burden 

published in the Federal Register.

3(c) Consultations

The primary source of information as reported by industry, in compliance with the 

recordkeeping and reporting provisions in the standard, is the Air Facility System (AFS) which is 

operated and maintained by the EPA Office of Compliance. AFS is the EPA database for the 
4

collection, maintenance, and retrieval of all compliance data. The growth rate for the industry was 

based on our consultations with the Agency’s internal industry experts. Approximately 119 

respondents will be subject to the standard over the three years period covered by this ICR.

Industry trade associations and other interested parties were provided an opportunity to 

comment on the burden associated with the standard as it was being developed and the standard 

has been previously reviewed to determine the minimum information needed for compliance 

purposes. 

It is our policy to carefully review any comments received since the last ICR renewal 

including those submitted in response to the first federal register notice and respond appropriately. 

In this case, no comments were received.

3(d) Effects of Less Frequent Collection

Less frequent information collection would decrease the margin of assurance that facilities 

are continuing to meet the standards. Requirements for information gathering and recordkeeping 

are useful techniques to ensure that good operation and maintenance practices are applied and 

emission limitations are met. If the information required by these standards was collected less 

frequently, the likelihood of detecting poor operation and maintenance of control equipment and 

noncompliance would decrease.

3(e) General Guidelines

None of these reporting or recordkeeping requirements violate any of the regulations 

established by OMB at 5 CFR part 1320, section 1320.5.

These standards require affected facilities to maintain all records, including reports and 

notifications for at least five years. This is consistent with the General Provisions as applied to the 

standards. EPA believes that the five-year records retention requirement is consistent with the part 

70 permit program and the five-year statute of limitations on which the permit program is based. 

Also, the retention of records for five years would allow EPA to establish the compliance history

of a source and any pattern of compliance for purposes of determining the appropriate level of 

enforcement action. Historically, EPA has found that the most flagrant violators frequently have 

violations extending beyond the five years. EPA would be prevented from pursuing the worst 

violators due to the destruction or nonexistence of records if records were retained for less than 

five years.

3(f) Confidentiality

The required information has been determined not to be confidential. However, any 

information submitted to the Agency for which a claim of confidentiality is made will be 

safeguarded according to the Agency policies set forth in title 40, chapter 1, part 2, subpart B -

Confidentiality of Business Information (CBI) (see 40 CFR 2; 41 FR 36902, September 1, 1976; 

amended by 43 FR 40000, September 8, 1978; 43 FR 42251, September 20, 1978; 44 FR 17674, 

March 23, 1979).
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3(g) Sensitive Questions

None of the reporting or recordkeeping requirements contain sensitive questions.

4. The Respondents and the Information Requested

4(a) Respondents/SIC Codes

Respondents are owners or operators of commercial EO sterilization and fumigation 

facilities. The United States Standard Industrial Classification (SIC) codes and corresponding 

North American Industry Classification System (NAICS) codes for EO sterilization facilities are 

listed in the table below.

Standard Description SIC Codes NAICS Codes

40 CFR part 

63, subpart O

Medical Equipment 

Suppliers

3841, 3842 339112, 339113,

Pharmaceutical Suppliers 2832, 2833, 2834, 5122 325411, 325412, 42221

Other Health-Related 

Facilities

2211, 2821, 2879, 3069, 

3079, 3569, 3677, 3693, 

3999, 5086

31321, 325211, 32532, 

333999, 334416, 

337127

Spice Manufacturers 2034, 2035, 2046, 2099, 

5149

311423, 311421, 

311941, 311942, 42249

Contract Sterilizers 7218, 7399, 8091 812332

Libraries, Museums, and 

Archives

8231, 8411 51412, 71211

Laboratories 0279, 7391, 7397, 8071, 

8922

112519, 54199, 

621512, 621511, 54169

4(b) Information Requested

None of these reporting or recordkeeping requirements violate any of the regulations 

established by OMB at 5 CFR part 1320, section 1320.5.

(i) Data Items

All data in this ICR that is recorded and/or reported is required by National Emission 

Standards for Hazardous Air Pollutants for Commercial Ethylene Oxide Sterilization and 

Fumigation Operations (40 CFR Part 63, Subpart O).

A source must make the following reports:
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Reports for 40 CFR part 63, subpart O

Notification of applicability 63.9(a)

Notification of construction/reconstruction 63.9(b)(3) and (4) 

Notification of actual startup 63.9(b)(2) and (4)

Notification of initial performance test 63.9(e)

Notification of compliance status 63.9(h)

Request for extension of compliance 63.9(c)

Request for waivers 63.7(h)

Request for alternative methods/monitoring 63.8(f)

Reports

Report of performance test results 63.10(d)(2)

Reports of noncompliance (including excess emissions reports) 63.10(e)(3)

A source must keep the following records:

Recordkeeping for 40 CFR part 63, subpart O

Records of control equipment maintenance; inspections, 

malfunctions; continuous monitoring systems malfunctions or in 

operation; calibrations and parameters; measurements to demonstrate 

compliance; performance test results; daily and monthly inspections; 

and documents supporting initial notifications and notification of 

compliance status

63.10(c)(1) and (5), 

63.10(b)(2)(ii), (iv-xii),

(xiv)

Retain records for five years 63.7(g)(3), 63.10(b)(1)

Emission testing (occurrence/duration) 63.10(b)(2)(ii), (vi-xii), 

(xiv)

Report of EO use 63.9(b)(2)

Electronic Reporting

Currently, sources are using monitoring equipment that provides parameter data in an 

automated way, e.g., leaks and spills of mercury. Although personnel at the source still need to 

evaluate the data, this type of monitoring equipment has significantly reduced the burden 

associated with monitoring and recordkeeping. In addition, some regulatory agencies are setting 

up electronic reporting systems to allow sources to report electronically which is reducing the 

reporting burden. However, electronic reporting systems are still not widely used by the 

regulatory agencies. It is estimated that approximately 10 percent of the respondents use 

electronic reporting.

(ii) Respondent Activities

(iii)
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Respondent Activities

Write the notifications and reports listed above.

Transmit, or otherwise disclose the information.

Train personnel to able to respond to a collection of information.

Submit the required reports developing, acquiring, installing, and utilizing technology and 

systems for the purpose of collecting, validating, and verifying information.

Perform initial performance test, Reference Method 2, 2A, 2C, or 2D, 18 or 25A test, and repeat 

performance tests if necessary.

Enter information required to be recorded above.

Develop, acquire, install, and utilize technology and systems for the purpose of processing and 

maintaining information.

Develop, acquire, install, and utilize technology and systems for the purpose of disclosing and 

providing information.

All monitoring systems and equipment must be installed, operational, and properly calibrated 

before the performance test.

Adjust existing ways to comply with any previously applicable instructions and requirements.

Currently, sources are using monitoring equipment that provides parameter data in an 

automated way. Although personnel at the source still need to evaluate the data, this type of 

monitoring equipment has significantly reduced the burden associated with monitoring and 

recordkeeping.

5. The Information Collected: Agency Activities, Collection Methodology, and Information 

Management

5(a) Agency Activities

EPA conducts the following activities in connection with the acquisition, analysis, storage, 

and distribution of the required information.

Agency Activities

Observe initial performance tests and repeat performance tests if necessary.

Review notifications and reports, including performance test reports, excess emissions reports, 

required to be submitted by industry.

Audit facility records.

Input, analyze, and maintain data in the Air Facility System (AFS).

5(b) Collection Methodology and Management

Following notification of startup, the reviewing authority might inspect the source to 

determine whether the pollution control devices are properly installed and operational. Performance 

test reports are used by the Agency to discern a source’s initial capability to comply with the 

emission standard, and note the operating conditions under which compliance was achieved. Data 

and records maintained by the respondents are tabulated and published for use in compliance and 
8

enforcement programs. The semiannual reports are used for problem identification, as a check on 

source operation and maintenance, and for compliance determinations.

Information contained in the reports is entered into the AFS which is operated and 

maintained by the EPA Office of Compliance. AFS is the EPA database for the collection, 

maintenance, and retrieval of compliance and annual emission inventory data for more than 

100,000 industrial and government-owned facilities. EPA uses the AFS for tracking air pollution 

compliance and enforcement by local and state regulatory agencies, EPA regional offices and EPA 

headquarters. EPA and its delegated Authorities can edit, store, retrieve and analyze the data.

The records required by this regulation must be retained by the owner or operator for five 

years.

5(c) Small Entity Flexibility

A majority of the affected facilities are primarily large entities (e.g., large businesses). 

The exact number of small entities affected by this rule could not be determined based on review 

of available documents, including the Ethylene Oxide Commercial Sterilization and Fumigation 

Operations NESHAP Implementation Document (EPA-456/R-97-004, updated March 2004). 

However, the impact on small entities was taken into consideration during the development of the 

regulation. Due to technical considerations involving the process operations and the type of 

control equipment employed, the recordkeeping and reporting requirements are the same for both 

small and large entities. The Agency considers these requirements the minimum needed to ensure 

compliance and, therefore, cannot reduce them further for small entities.

5(d) Collection Schedule

The specific frequency for each information collection activity within this request is shown 

below in Table 1: Annual Respondent Burden and Cost - NESHAP for Commercial Ethylene 

Oxide Sterilization and Fumigation Operations (40 CFR Part 63, Subpart O) (Renewal).

6. Estimating the Burden and Cost of the Collection

Table 1 documents the computation of individual burdens for the recordkeeping and 

reporting requirements applicable to the industry for the subpart included in this ICR. The 

individual burdens are expressed under standardized headings believed to be consistent with the 

concept of burden under the Paperwork Reduction Act. Wherever appropriate, specific tasks and 

major assumptions have been identified. Responses to this information collection are mandatory.

The 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.

6(a) Estimating Respondent Burden

The average annual burden to industry over the next three years from these recordkeeping 

and reporting requirements is estimated to be 8,662 (Total Labor Hours from Table 1). These 
9

hours are based on Agency studies and background documents from the development of the 

regulation, Agency knowledge and experience with the NESHAP program, the previously

approved ICR, and any comments received.

6(b) Estimating Respondent Costs

(i) Estimating Labor Costs

This ICR uses the following labor rates: 

Managerial $114.49 ($54.52 + 110%) 

Technical $98.20 ($46.76 + 110%)

Clerical $48.53 ($23.11 + 110%)

These rates are from the United States Department of Labor, Bureau of Labor Statistics, 

September 2009, “Table 2. Civilian Workers, by Occupational and Industry group.” The rates are 

from column 1, “Total compensation.” The rates have been increased by 110 percent to account 

for the benefit packages available to those employed by private industry.

(ii) Estimating Capital/Startup and Operation and Maintenance Costs

The types of industry costs associated with the information collection activities in the 

subject standard are both labor costs which are addressed elsewhere in this ICR and the costs 

associated with continuous monitoring. The capital/startup costs are one-time costs when a 

facility becomes subject to the regulation. The annual operation and maintenance costs are the 

ongoing costs to maintain the monitor and other costs such as photocopying and postage.

(iii) Capital/Startup vs. Operation and Maintenance (O&M) Cost

Capital/Startup vs. Operation and Maintenance (O&M) Costs

(A)

Continuous 

Monitoring 

Device

(B)

Capital/Startup 

Cost for One 

Respondent

(C)

Number of 

New

Respondents

(D)

Total 

Capital/Startup 

Cost,

(B X C)

(E)

Annual O&M 

Costs for One 

Respondent

(F)

Number of 

Respondents 

with O&M

(G)

Total 

O&M,

(E X F)

Computer 

equipment and 

gas 

chromatograph 

used to 

continuously 

monitor EO 

emissions to 

aeration room

and back 

chamber vents

$32,500 2 $65,000 $5,500 106 $583,000

The total capital/startup costs for this ICR are $65,000. This is the total of column D in the 

above table. 
10

The total operation and maintenance (O&M) costs for this ICR are $583,000. This is the 

total of column G. 

The average annual cost for capital/startup and operation and maintenance costs to industry 

over the next three years of the ICR is estimated to be $648,000.

6(c) Estimating Agency Burden and Cost

The only costs to the Agency are those costs associated with analysis of the reported 

information. The EPA compliance and enforcement program includes activities such as the 

examination of records maintained by the respondents, periodic inspection of sources of 

emissions, and the publication and distribution of collected information.

The average annual Agency cost during the three years of the ICR is estimated to be 

$26,679. This cost is based on the average hourly labor rate as follows:

Managerial $62.27 (GS-13, Step 5, $38.92 + 60%) 

Technical $46.21 (GS-12, Step 1, $28.88 + 60%)

Clerical $25.01 (GS-6, Step 3, $15.63 + 60%)

These rates are from the Office of Personnel Management (OPM), 2010 General Schedule, which 

excludes locality rates of pay. The rates have been increased by 60 percent to account for the 

benefit packages available to government employees. Details upon which this estimate is based 

appear below in Table 2: Average Annual EPA Burden – NESHAP for Commercial Ethylene 

Oxide Sterilization and Fumigation Operations (40 CFR part 63, subpart O) (Renewal).

6(d) Estimating the Respondent Universe and Total Burden and Costs

Based on our research for this ICR, there are approximately 119 existing sources currently 

subject to the standard. It is estimated that two additional sources per year will become subject to 

the regulation in the next three years. However, we estimate that 10 percent or approximately 12 

facilities will use only limited amounts of EO and therefore, will not be required to submit reports.

Number of respondents is calculated using the following table which addresses the three 

years covered by this ICR.

Number of Respondents

Year

(A)

Number of 

New

Respondents

(B)

Number of 

Existing 

Respondents

(C)

Number of Existing 

Respondents That 

Keep Records But Do 

Not Submit Reports

(D)

Number of Existing 

Respondents That 

Are Also New

Respondents

(E)

Number of 

Respondents

(E=A+B+C-D)

1 2 105 12 1 118

2 2 106 12 1 119

3 2 107 12 1 120
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Number of Respondents

Year

(A)

Number of 

New

Respondents

(B)

Number of 

Existing 

Respondents

(C)

Number of Existing 

Respondents That 

Keep Records But Do 

Not Submit Reports

(D)

Number of Existing 

Respondents That 

Are Also New

Respondents

(E)

Number of 

Respondents

(E=A+B+C-D)

Average 2 106 12 1 119

To avoid double-counting respondents, column D is subtracted. As shown above, the average 

Number of Respondents over the three-year period of this ICR is 119.

The total number of annual responses per year is calculated using the following table:

Respondent Universe and Number of Responses Per Year

Regulation 

Citation

(A)

Average 

Number of 

New

Respondents 

per Year

(B)

Number of 

Reports for 

New

Sources

(C)

Number of 

Existing 

Respondents

(D)

Number of 

Reports for 

Existing 

Sources

(F)

Number of 

Respondents That 

Keep Records But 

Do Not Submit 

Reports

(E)

Total Annual 

Responses =

(AxB)+(CxD)

+F

40 CFR 

part 63, 

subpart O

2 6.1 106 2 12 236 (rounded)

The number of total respondents is 119.

The number of Total Annual Responses is 236. This is the number in column E of the 

Respondent Universe and Number of Responses Per Year table above.

The total annual labor costs are $819,301. Details regarding these estimates may be found 

in below Table 1: Annual Respondent Burden and Cost - NESHAP for Commercial Ethylene 

Oxide Sterilization and Fumigation Operations (40 CFR Part 63, Subpart O) (Renewal).

6(e) Bottom Line Burden Hours Burden Hours and Cost Tables

The detailed bottom line burden hours and cost calculations for the respondents and the 

Agency are shown in Tables 1 and 2, respectively, and summarized below. 

(i) Respondent Tally

The total annual labor hours are 8,662. Details regarding these estimates may be found

below in Table 1: Annual Respondent Burden and Cost – NESHAP for Commercial Ethylene 

Oxide Sterilization and Fumigation Operations (40 CFR part 63, subpart O) (Renewal). 

Furthermore, the annual public reporting and recordkeeping burden for this collection of 

information is estimated to average 37 hours per response.

The total annual capital/startup and O&M costs to the regulated entity are $648,000. The 

cost calculations are detailed in Section 6(b)(iii), Capital/Startup vs. Operation and Maintenance 
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(O&M) Costs.

(ii) The Agency Tally

The average annual Agency burden and cost over next three years is estimated to be 592

labor hours at a cost of $26,679. See below Table 2: Annual Agency Burden and Cost – NESHAP 

for Commercial Ethylene Oxide Sterilization and Fumigation Operations (40 CFR part 63, subpart 

O) (Renewal).

6(f) Reasons for Change in Burden

There is no change in the labor hours to respondents in this ICR compared to the previous 

ICR. This is due to two considerations: (1) the regulations have not changed over the past three 

years and are not anticipated to change over the next three years; and (2) the growth rate for the 

industry is very low, negative or non-existent. Therefore, the labor hours in the previous ICR 

reflect the current burden to the respondents and are reiterated in this ICR. 

The increase in labor cost to the respondents and the Agency is due to the updating of labor 

rates to reflect current cost figures. 

6(g) Burden Statement

The annual public reporting and recordkeeping burden for this collection of information is 

estimated to average 37 hours per response. Burden means the total time, effort, or financial 

resources expended by persons to generate, maintain, retain, or disclose or provide information to 

or for a Federal agency. This includes the time needed to review instructions; develop, acquire, 

install, and utilize technology and systems for the purposes of collecting, validating, and verifying 

information, processing and maintaining information, and disclosing and providing information; 

adjust the existing ways to comply with any previously applicable instructions and requirements; 

train personnel to be able to respond to a collection of information; search data sources; complete 

and review the collection of information; and transmit or otherwise disclose the information.

An agency may not conduct or sponsor, and a person is not required to respond to, a 

collection of information unless it displays a valid OMB Control Number. The OMB Control 

Numbers for EPA regulations are listed at 40 CFR part 9 and 48 CFR chapter 15.

To comment on the Agency's need for this information, the accuracy of the provided 

burden estimates, and any suggested methods for minimizing respondent burden, including the use 

of automated collection techniques, EPA has established a public docket for this ICR under Docket 

ID Number EPA–HQ–OECA–2009–0392. An electronic version of the public docket is available 

at http://www.regulations.gov/ which may be used to obtain a copy of the draft collection of 

information, submit or view public comments, access the index listing of the contents of the docket, 

and to access those documents in the public docket that are available electronically. When in the 

system, select “search,” then key in the docket ID number identified in this document. The 

documents are also available for public viewing at the Enforcement and Compliance Docket and 

Information Center in the EPA Docket Center (EPA/DC), EPA West, Room 3334, 1301 
13

Constitution Avenue, N.W., Washington, D.C. The EPA Docket Center Public Reading Room is 

open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The 

telephone number for the Reading Room is (202) 566-1744, and the telephone number for the 

docket center is (202) 566-1752. Also, you can send comments to the Office of Information and 

Regulatory Affairs, Office of Management and Budget, 725 17th Street, N.W., Washington, D.C. 

20503, Attention: Desk Officer for EPA. Please include the EPA Docket ID Number 

EPA–HQ–OECA–2009–0392 and OMB Control Number 2060-0283 in any correspondence. 

Part B of the Supporting Statement

This part is not applicable because no statistical methods were used in collecting this 

information.
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Table 1: Annual Respondent Burden and Cost - NESHAP for Commercial Ethylene Oxide Sterilization and Fumigation Operations (40 CFR Part 63, Subpart O)

(Renewal)

A B C D E F G H I

Reporting/Recordkeeping Requirements

Hours/

Occurrence

Occurrences/

Year

Hours/Year

(C = A x B)

Respondents/

Year a

Technical

Hours/Year

(C*D)

Managerial

Hours/Year

(E*0.05)

Clerical

Hours/Year

(E*0.10)

Total

Hours/Year

(H=E+F+G)

Total

Costs/Year b

1. Applications N/A

2. Survey and Studies N/A

3. Reporting Requirements

A. Read Instructions 1 1 1 2 2.00 0.10 0.20 2.30 $217.56

B. Required Activities

Initial Performance Test c 200 1 200 2 400.00 20.00 40.00 460.00 $43,511.00

Repeat Performance Test c, d 200 0.2 40 2 80.00 4.00 8.00 92.00 $8,702.20

Preparation of Site-Specific Test Plan Included Above

C. Create Information See 3B

D. Gather Existing Information See 3B

E. Write Reports

Notification of Applicability e 2 1 2 2 4.00 0.20 0.40 4.60 $435.11

Notification of Construction/Reconstruction e 2 1 2 2 4.00 0.20 0.40 4.60 $435.11

Notification of Actual Startup e2 1 2 2 4.00 0.20 0.40 4.60 $435.11

Notification of Initial Performance Test e2 1 2 2 4.00 0.20 0.40 4.60 $435.11

Notification of Compliance Status e2 1 2 2 4.00 0.20 0.40 4.60 $435.11

Request for Extension of Compliance, Adjustment to 

Time Periods, and Changes in Information 2 1 2 0 0.00 0 0 0 $0

Requiest for a Waiver f6 1 6 0.1 0.60 0.03 0.06 0.69 $65.27

Report for Alternative Method/Monitoring f6 1 6 0.1 0.60 0.03 0.06 0.69 $65.27

Report of Performance Test g24 1 24 2 48.00 2.40 4.80 55.20 $5,221.32

Reports of Periods of Noncompliance

(Including Excess Emissions) h 14 2 28 106 2,968.00 148.40 296.80 3,413.20 $322,851.62

Reporting Subtotal 4,047 $382,810
15

Table 1: Annual Respondent Burden and Cost - NESHAP for Commercial Ethylene Oxide Sterilization and Fumigation Operations (40 CFR Part 63, Subpart O)

(Renewal), (Continued)

4. Recordkeeping Requirements

A. Read Instructions 1 1 1 4.3 4.30 0.22 0.43 4.95 $467.74

B. Plan Activities See 3E

C. Implement Activities See 3E

D. Develop Record System See 3E

E. Time to Enter Information

Record of Operating Parameters and Emissions i 0.1 365 36.5 106 3,869.00 193.45 386.90 4,449.35 $420,860.15

Records of EO Use j, k 0.6 12 7.2 12 86.40 4.32 8.64 99.36 $9,398.38

F. Time to Transmit or Disclose Information l 0.25 2 0.5 106 53.00 2.65 5.30 60.95 $5,765.21

G. Train Personnel N/A

H. Time for Audits N/A

Recordkeeping Subtotal 4,615 $436,491

TOTAL LABOR BURDEN AND COST (ROUNDED) 8,662 $819,301

Assumptions:

a) It is assumed that the average number of respondents that will be subject to the rule will be the 119 existing respondents. There will be two additional new sources per year that 

will become subject to the rule over the 3-year period of this ICR.

b) This ICR uses the following labor rates: Managerial $114.49 ($54.52 + 110 percent); Technical $98.20 ($46.76 + 110 percent); and Clerical $48.53 ($23.11 + 110 percent). These 

rates are from the United States Department of Labor, Bureau of Labor Statistics, March 2009, "Table 2. Civilian workers, by Occupational and Industry group." The rates are 

from column 1, "Total compensation." The rates have been increased by 110 percent to account for the benefit packages available to those employed by private industry. This ICR 

assumes that Managerial hours are 5 percent of Technical hours, and Clerical hours are 10 percent of Technical hours.

c) It is assumed that it will take 200 hours for each respondent to perform the initial performance test and also repeat testing.

d) It is assumed that 20 percent of respondents will have to repeat performance tests due to failure.

e) It is assumed that it will initially take each of the new respondents two hours to write each notification report.

f) It is assumed that 10 percent of new facilities will take 6 hours to write requests for waivers.

g) It is assumed that each respondent will take 24 hours to prepare performance test reports.

h) It is assumed that 106 respondents will take 14 hours to complete reports of periods of noncompliance, which includes excess emissions. This will occur two times per year.

i) It is assumed that 106 respondents will enter information on record of operating parameters and emissions 365 times per year.

j) It is assumed that the average number of affected facilities required to record EO usage is 12.

k) It is assumed that each of the 12 respondents will record EO use 12 times per year.

l) It is assumed that 106 respondents will disclose information two times per year.
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Table 2: Average Annual EPA Burden - NESHAP for Commercial Ethylene Oxide Sterilization and Fumigation Operations (40 CFR Part 63, Subpart O) (Renewal)

(A) (B) (C) (D) (E) (F) (G) (H) (I)

Activity

EPA

Hours/

Occurrence

Occurrences/

Plant/Year

EPA

Hours/Year

(C=A*B)

Plants/

Year a

Technical

Hours/Year

(C*D)

Managerial

Hours/Year

(E*0.05)

Clerical

Hours/Year

(E*0.10)

Total

Hours/Year

(H=E+F+G)

Total

Costs/Year b

Initial Performance Tests

New or Modified Facility c 40 1 40 2 80.00 4.00 8.00 92.00 $4,145.96

Repeat Performance Tests

New or Modified Facility d 136 1 136 0.4 54.40 2.72 5.44 62.56 $2,819.25

Report Review

New or Modified Facility

Notification of Applicability e 2 1 2 2 4.00 0.20 0.40 4.60 $207.30

Notification of 

Construction/Reconstruction e 2 1 2 2 4.00 0.20 0.40 4.60 $207.30

Notification of Actual Startup e 2 1 2 2 4.00 0.20 0.40 4.60 $207.30

Notification of Initial Performance 

Test e 2 1 2 2 4.00 0.20 0.40 4.60 $207.30

Notification of Compliance Status e

2 1 2 2 4.00 0.20 0.40 4.60 $207.30

Request for Extension of 

Compliance, Adjustment to Time 

Periods, and Changes in 

Information 2 1 2 2 4.00 0.20 0.40 4.60 $207.30

Request for Waiver g 4 1 4 0.2 0.80 0.04 0.08 0.92 $41.46

Request for Alternative 

Method/Monitoring h 4 1 4 0.1 0.40 0.02 0.04 0.46 $20.73

Report of Performance Test i 8 1 8 2 16.00 0.80 1.60 18.40 $829.19

Report of Periods of 

Noncompliance (Including Excess 

Emissions) j

8 2 16 21.2 339.20 16.96 33.92 390.08 $17,578.87

Report Review Subtotal 437 $26,679

TOTAL ANNUAL BURDEN 592 $26,679

Assumptions:

a) It is assumed that the average number of respondents that will be subject to the rule will be the 119 existing respondents. There will be two additional new sources per year that 

will become subject to the rule over the three-year period of this ICR. There are 106 facilities submitting reports.

b) This ICR uses the following labor rates: Managerial $62.27 (GS-13, Step 5, $38.92 + 60%); Technical $46.21 (GS-12, Step 1, $28.88 + 60%); and Clerical $25.01 (GS-6, Step 3, 

$15.63 + 60%). These rates are from the Office of Personnel Management (OPM), 2010 General Schedule, which excludes locality rates of pay. The rates have been increased by 

60 percent to account for the benefit packages available to government employees. This ICR assumes that Clerical hours are 10 percent of Technical hours and Managerial hours 

are 5 percent of Technical hours.

c) It is assumed that it will take 40 hours for each respondent to participate with the performance test. Twenty percent of respondents will fail the performance test.

d) It is assumed that 20 percent of respondents will fail the performance test and will have to repeat it.

e) It is assumed that it will take two hours for each respondent to review the notification report.

f) It is assumed that it will take two hours for each respondent to review the request for extension of the compliance report.

g) It is assumed that 10 percent of new facilities will request a waiver.
17

h) It is assumed that five percent of new facilities will request an alternative method/monitoring.

i) It is assumed that each new respondent will take eight hours to review the report of performance test results.

j) It is assumed that 20 percent of respondents submitting reports will take eight hours to review reports of periods of noncompliance.