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 1666.09, 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 were proposed on March 

7, 1994, promulgated on December 6, 1994, and last amended on December 19, 2005. These 

regulations were amended on December 14, 1999 for Title V operating permit deferrals for area 

sources. 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. New facilities include those that commenced construction or 

reconstruction after the date of proposal. This information is being collected to assure 

compliance with 40 CFR part 63, subpart O.

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

periodic reports by the owners/operators of the affected facilities. They 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 affected facilities subject to NESHAP. 

Any owner/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 U. S.

Environmental Protection Agency (EPA) regional office.

Over the next three years, an average of 122 respondents per year will be subject to the 

standard, and two additional respondents per year will become subject to the standard. 

The Office of Management and Budget (OMB) approved the currently active ICR 

without any “Terms of Clearance.”

There are 122 commercial ethylene oxide sterilization and fumigation facilities in the 

United States; all are commercially-owned and operated by the ethylene oxide sterilization and 

fumigation industry. None of the 122 facilities in the United States are owned by either state, 
2

local, tribal or the Federal government entitites; they are all owned and operated solely by 

privately-owned, for-profit businesses. 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 Federal 

Government “burden” is attributed entirely to work performed by either Federal employees or 

government contractors and may be found below in Table 2: Average Annual EPA Burden and 

Cost – 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. These standards are applicable to new or existing sources of hazardous 

air pollutants and shall require the maximum degree of emission reduction. In addition, section 

114(a) states that the Administrator may require any owner/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 were promulgated for this source category at 40 CFR 

part63, subpart O.

2(b) Practical Utility/Users of the Data

The recordkeeping and reporting requirements in the standard ensure compliance with 

the applicable regulations which where promulgated in accordance with the Clean Air Act. The 

collected information is also used for targeting inspections and as evidence in legal proceedings.

Performance tests are required in order to determine an affected facility’s initial 

capability to comply with the emission standards. Continuous emission monitors are used to 
3

ensure compliance with the standards at all times. During the performance test a record of the 

operating parameters under which compliance was achieved may be recorded and used to 

determine compliance in place of a continuous emission monitor. 

The notifications required in the standard 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, leaks are being detected and repaired, and the standards are being met. 

The performance test may also be observed.

The required semiannual reports are used to determine periods of excess emissions, 

identify problems at the facility, verify operation/maintenance procedures and for compliance 

determinations.

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 its 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, 

duplication does not exist.

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 (77 FR 63813) on October 17, 2012. No comments were received on the 

burden published in the Federal Register. 

3(c) Consultations

The Agency’s industry experts have been consulted, and the Agency’s internal data 

sources and projections of industry growth over the next three years have been considered. 

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

and reporting provisions in the standard, is the Online Tracking Information System (OTIS) 

which is operated and maintained by EPA's Office of Compliance. OTIS is EPA’s database for 

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

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

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

comment on the burden associated with the standards as it was being developed and the 
4

standards have been reviewed previously to determine the minimum information needed for 

compliance purposes. In developing this ICR, we contacted: 1) the Ethylene Oxide Sterilization 

Association, Incorporated (EOSA), at (866) 235-5030; and 2) the Sterilization Services, at (404) 

344-8423.

It is our policy to respond after a thorough review of comments received since the last 

ICR renewal as well as those submitted in response to the first Federal Register notice. 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 proper operation and maintenance of control equipment and the 

possibility of detecting violations would be less likely.

3(e) General Guidelines

These reporting or recordkeeping requirements do not violate any of the regulations 

promulgated by OMB under 5 CFR part 1320, section 1320.5.

These standards require the respondents 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

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

based. The retention of records for five years allows EPA to establish the compliance history of 

a source, any pattern of non-compliance and to determine the appropriate level of enforcement 

action. EPA has found that the most flagrant violators have violations extending beyond five 

years. In addition, EPA would be prevented from pursuing the violators due to the destruction or 

nonexistence of essential records.

3(f) Confidentiality

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).

3(g) Sensitive Questions

The reporting or recordkeeping requirements in the standard do not include sensitive 

questions.
5

4. The Respondents and the Information Requested

4(a) Respondents/SIC Codes

The respondents to the recordkeeping and reporting requirements are owners or operators 

of commercial EO sterilization and fumigation facilities. The United States Standard Industrial 

Classification (SIC) codes for the respondents affected by the standards and the corresponding

North American Industry Classification System (NAICS) codes are listed in the table below.

Standard (40 CFR Part 63, Subpart O) SIC Codes NAICS Codes

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

(i) Data Items

In this ICR, all the data that is recorded or reported is required by the NESHAP for 

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

O). 

A source must make the following reports:

Notifications

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)
6

Notifications

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

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), (ivxii), (xiv)

Retain records for five years

63.7(g)(3), 

63.10(b)(1)

Emission testing (occurrence/duration) 63.10(b)(2)(ii), (vixii), (xiv)

Report of EO use 63.9(b)(2)

Electronic Reporting

Some of the respondents are using monitoring equipment that automatically records 

parameter data. Although personnel at the affected facility must still evaluate the data, internal 

automation has significantly reduced the burden associated with monitoring and recordkeeping at 

a plant site. 

Also, regulatory agencies in cooperation with the respondents continue to create reporting 

systems to transmit data electronically. However, electronic reporting systems are still not 

widely used. At this time, it is estimated that approximately 10 percent of the respondents use 

electronic reporting.
7

(ii) Respondent Activities

Respondent Activities

Read instructions.

Install, calibrate, maintain, and operate CMS for opacity, or for pressure drop and liquid 

supply pressure for control device.

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

repeat performance tests if necessary.

Write the notifications and reports listed above.

Enter information required to be recorded above.

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

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

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.

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

Transmit, or otherwise disclose the information.

Currently sources are using monitoring and reporting equipment that provide parameter 

data in an automated way (e.g., continuous parameter monitoring system). 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.
8

Agency Activities

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

reports, required to be submitted by industry.

Audit facility records.

Input, analyze, and maintain data in the Online Tracking Information System (OTIS). 

5(b) Collection Methodology and Management

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

determine whether the pollution control devices are properly installed and operated. 

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

with the emission standard. Data and records maintained by the respondents are tabulated and 

published for use in compliance and 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 OTIS which is operated and 

maintained by EPA's Office of Compliance. OTIS is EPA’s database for the collection, 

maintenance, and retrieval of compliance data for approximately 125,000 industrial and 

government-owned facilities. EPA uses the OTIS 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/operator for five 

years.

5(c) Small Entity Flexibility

A majority of the respondents are large entities (i.e., 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 (i.e., small businesses) was taken into consideration during the 

development of the regulation. Due to technical considerations involving the process operations 

and the types of control equipment employed, the recordkeeping and reporting requirements are 

the same for both small and large entities. The Agency considers these to be the minimum 

requirements needed to ensure compliance and, therefore, cannot reduce them further for small 

entities. To the extent that larger businesses can use economies of scale to reduce their burden, 

the overall burden will be reduced.
9

5(d) Collection Schedule

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

shown 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. 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 8,887 hours (Total Labor Hours from Table 1

below). These 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 $121.44 ($57.83 + 110%) 

Technical $100.23 ($47.73 + 110%)

Clerical $50.51 ($24.05 + 110%)

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

2012, “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 type 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 
10

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) Costs

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 GC 1

$32,500 2 $65,000 $5,500 109 $599,500

1 Computer equipment and gas chromatograph (GC) are used to continuously monitor EO emissions to aeration 

room and back chamber vents

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

the above table. 

The total operation and maintenance (O&M) costs for this ICR are $599,500. 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 $664,500. These are the costs 

of recordkeeping.

6(c) Estimating Agency Burden and Cost

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

information. EPA's overall 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 

$27,177. 

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), 2012 General Schedule,

which excludes locality rates of pay. The rates have been increased by 60 percent to account for 
11

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

based appear below in Table 2: Average Annual EPA Burden and Cost – 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, approximately 121existing respondents will be 

subject to the standards on average over 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. It is estimated that an additional two respondents per year will 

become subject. The overall average number of respondents, as shown in the table below is 122

per year

The number of respondents is calculated using the following table that addresses the three 

years covered by this ICR. 

Number of Respondents

Year

(A)

Number of New 

Respondents 1

(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 2 108 12 1 121

2 2 109 12 1 122

3 2 110 12 1 123

Average 2 109 12 1 122

1

New respondent include sources with constructed, reconstructed and modified affected facilities. 

.

Column D is subtracted to avoid double-counting respondents. As shown above, the 

average Number of Respondents over the three year period of this ICR is 122. 

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

Total Annual Responses
12

Total Annual Responses

(A)

Information Collection Activity

(B)

Number of 

Respondents 

(C)

Number of 

Responses

(D)

Number of Existing 

Respondents That 

Keep Records But Do 

Not Submit Reports

(E)

Total Annual Responses 

E=(BxC)+D

Notification of Applicability 2 1 0 2

Notification of 

Construction/Reconstruction 2 1 0 2

Notification of Actual Startup 2 1 0 2

Notification of Initial 

Performance Test 2 1 0 2

Notification of Compliance 

Status 2 1 0 2

Request for Waiver 2 0.05 0 0.1

Report for Alternative 

Method/ Monitoring 2 0.05 0 0.1

Report for Performance Test 2 1 0 2

Reports for Periods of 

Noncompliance 109 2 12 230

Total 242.2

The number of Total Annual Responses is 242 (rounded). 

The total annual labor costs are $860,413. 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).

6(e) Bottom Line 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 8,887 hours at a cost of $860,413. 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.
13

The total annual capital/startup and O&M costs to the regulated entity are $664,500. The 

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

(O&M) Costs.

(ii) The Agency Tally

The average annual Agency burden and cost over next three years is estimated to be 603 

labor hours at a cost of $27,177. See below Table 2: Average Annual EPA 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 an adjustment increase in burden for both the respondents and the Agency from 

the most recently approved ICR. This is not due to any program changes. The increase is due to 

an update in labor rates and an increase of three respondents subject to the regulation since the 

last ICR. This results in an increase in respondent and Agency labor hours, costs, and total 

O&M costs. 

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-2012-0664. 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 
14

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 Constitution Ave., NW, Washington, DC. 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, NW, 

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

Number EPA-HQ-OECA-2012-0664 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.
15

Table 1: Annual Respondent Burden and Cost – NESHAP for Commercial Ethylene Oxide Sterilization and Fumigation

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

Burden Items 

(A) 

Hours per 

occurrence

(B) 

Occurrences 

per year

(C) 

Hours per 

year 

(AxB)

(D) 

Respondents 

per

year a

(E) 

Technical 

hours per 

year 

(CxD)

(F) 

Managerial 

hours per 

year 

(Ex0.05)

(G) 

Clerical 

hours per 

year 

(Ex0.10)

(H) 

Total

Cost per

year, $ b

1. Applications N/A

2. Survey and Studies N/A

3. Reporting Requirements

A. Read Instructions 1 1 1 2 2 0.1 0.2 $222.71

B. Required Activities

Initial performance test c 200 1 200 2 400 20 40 $44,541.20

Repeat performance test c, d 200 0.2 40 2 80 4 8 $8,908.24

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 0.2 0.4 $445.41

Notification of construction/reconstruction e 2 1 2 2 4 0.2 0.4 $445.41

Notification of actual startup e 2 1 2 2 4 0.2 0.4 $445.41

Notification of initial performance test e 2 1 2 2 4 0.2 0.4 $445.41

Notification of compliance status e 2 1 2 2 4 0.2 0.4 $445.41

Request for extension of compliance, adjustment 

to time periods, and changes in information 

2 1 2 0 0 0 0 $0

Request for waiver f 6 1 6 0.1 0.6 0.03 0.06 $66.81

Report for alternative method monitoring f 6 1 6 0.1 0.6 0.03 0.06 $66.81

Report for performance test g 24 1 24 2 48 2.4 4.8 $5,344.94
16

Burden Items 

(A) 

Hours per 

occurrence

(B) 

Occurrences 

per year

(C) 

Hours per 

year 

(AxB)

(D) 

Respondents 

per

year a

(E) 

Technical 

hours per 

year 

(CxD)

(F) 

Managerial 

hours per 

year 

(Ex0.05)

(G) 

Clerical 

hours per 

year 

(Ex0.10)

(H) 

Total

Cost per

year, $ b

Reports for periods of noncompliance (including 

excess emissions) h

14 2 28 109 3,052 152.6 305.2 $339,849.36

Subtotal for Reporting 4,143.68 $401,227.13

4. Recordkeeping Requirements

A. Read Instructions 1 1 1 4.3 4.3 0.215 0.43 $478.82

B. Plan Activities See 3B

C. Implement Activities See 3B

D. Develop Record System See 3B

E. Time to Enter Information

Record of operating parameters and emissions i 0.1 365 36.5 109 3,979 198.95 397.9 $443,017.91

Records of EO use j, k 0.6 12 7.2 12 86.4 4.32 8.64 $9,620.90

F. Time to transmit or disclose information l 0.25 2 0.5 109 54.5 2.725 5.45 $6,068.74

G. Train Personnel N/A

H. Time for Audits N/A

Subtotal for Recordkeeping 4,742.83 $459,186.37

Total Labor Burden and Cost (rounded) 8,887 $860,413

Assumptions:

a The average number of respondents that will be subject to the rule will be the 122 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: $121.44 for Managerial, $100.23 for Technical, and $50.51 for Clerical.

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 5 hours to write requests for waivers.

g

 It is assumed that each respondent will take 24 hours to prepare performance test reports.
17

h

 It is assumed that 109 respondents will take 14 hours to complete reports of periods of noncompliance, which includes excess emissions. This will occur 

two time per year.

i It is assumed that 109 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 109 respondents will disclose information two time per year.
18

Table 2: Average Annual EPA Burden and Cost – NESHAP for Commercial Ethylene Oxide Sterilization and Fumigation 

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

Activity

(A) 

EPA Hours 

per 

Occurrence

(B) 

Occurrences 

per Year

(C) 

EPA 

Hours 

per Year 

(AxB)

(D) 

Plants 

per 

Year a

(E) 

Technical 

Hours 

per Year 

(CxD)

(F) 

Managerial 

Hours per 

Year 

(Ex0.05)

(G) 

Clerical 

hours per 

year 

(Ex0.10)

(H) 

Total

cost per

year $

b

Initial performance tests

New or modified facility c 40 1 40 2 80 4 8 $4,145.96

Repeat performance tests

New or modified facility d 136 1 136 0.4 54.4 2.72 5.44 $2,819.25

Report Review

New or modified facility

Notification of applicability 2 1 2 2 4 0.2 0.4 $207.30

Notification of construction/reconstruction e 2 1 2 2 4 0.2 0.4 $207.30

Notification of actual startup e 2 1 2 2 4 0.2 0.4 $207.30

Notification of initial performance test e 2 1 2 2 4 0.2 0.4 $207.30

Notification of compliance status e

2 1 2 2 4 0.2 0.4 $207.30

Request for extension of compliance, 

adjustment to time periods, and changes in 

information

2 1 2 2 4 0.2 0.4 $207.30

Request for waiver g 4 1 4 0.2 0.8 0.04 0.08 $41.46

Request for alternative method/monitoring h4 1 4 0.1 0.4 0.02 0.04 $20.73

Report of performance test i 8 1 8 2 16 0.8 1.6 $829.19

Report of periods of noncompliance 

(including excess emissions) j 8 2 16 21.8 348.8 17.44 34.88 $18,076.39

Total Labor Burden and Cost (rounded) 603 $27,177
19

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: $62.27 for Managerial, $46.21 for technical, and $25.01 for Clerical.

c

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

will fail the performance test.

d

 It is assumed that 20 percent of respondent 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.

h

 It is assumed that 5 percent of new facilities will request an alternative method monitoring.

i It is assumed that each new respondent will take 8 hours to review the report of performance test results.

j

 It is assumed that 20 percent of respondents submitting reports will take 8 hours to review reports of period of noncompliance.