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 Infor mation Collection NESHAP for Commercial Ethylene Oxide Sterilization and Fumigation Operations (40 CFR Part 63, Subpart O) (Renewal) , EPA I CR 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 appl y to new and existing co mmercial 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, al l 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 sy stem 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 Ethyl ene Oxide Sterilization Association, which represents the vast majority

of facilities subject to this standard, was consulted t o 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.2

EPA has addressed each i tem 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 publicl y owned and operated b y the ethyl ene oxide sterilization and fumigation industry

. N one of the 119 facilities in the United States are owned by e ither state, local, tribal or the Federal government, they are all owned and operated solel y b y privately owned for

- profit businesses, thus, the Federal government burden does not include work performed by federal emplo yees onl y work performed b y contractors. The burden to the “Affected Public” may be found below in Table 1: Annual Respondent Burden and Cost

- NES HAP for Commercial Ethylene Oxide Sterilization and Fumigation Operations (40 CFR part 63, subpart O) (Renewal) . The burden to the “Federal government” is attributed entirel y to work performed b y 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 exis ting sources of HAP and shall require the maximum degree of emission reduction. In addition, section 114(a) states that the Administrator may require any o wner 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 accord ance with Section 114(a)(3); and (G) provide such other information as the Administrator may reasonabl y require. In the Administrator's judgment, EO emissions from sterilization facilities cause or contribute to air pollution that may reasonabl y b e anti cipated to endanger public health or welfare. Therefore, the NESHAP was promulgated for this source category at 40 CFR part 63, subpart O.3

2(b) Practical Utility/Users of the Data The control of EO emissions from sterilization facilities requires not o nl y the installation of properl y 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 b y the reduction of EO emissions using acid

- water scrubbers or catal ytic/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 regulatio ns. The reviewing authority may then inspect the source to check if the pollution control devices are properl y 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 I CR is used by the Agency

to ensure that fac ilities 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 requ ested 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 i s sent directl y to the delegated state or local agency
. If a state or local agency h as adopted their own similar standards to implement the Federal standards, a cop y of the report submitted to the state or local agency can be sent to the Administrator in lieu of the report required b y 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 IC R was published in the Federal Regist er (74 FR 3258 1 ) 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 Sy stem (AFS) which is operated and maintained by the EPA Office of Compliance. AFS is the EPA database for the4

collection, maintenance, and retrieval of all compliance data. The growth rate for the industry w as based on our consultations with the Agency ’s internal industry experts. Approximately

119 respondents will be subject to the standard over the three ye ars period covered by this I CR. 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 rec eived since the last ICR renewal including those submitted in response to the first federal register notice and respond appropriatel y. In this case, no comments were received. 3(d) Effects of Less Frequent Collection Less frequent information collectio n 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 b y these standards was collected less frequentl y, 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. E PA believes that the five

- ye ar records retention requirement is consistent with the part 70 permit program and the five

- ye ar statute of limitations on which the permit program is based. Also, the retention of records for five ye ars 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 th at 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 b y 43 FR 40000, September 8, 1978; 43 FR 42251, September 20, 1978; 44 FR 17674, March 23, 1979).5

3(g) Sensitive Questio ns 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 faciliti es. The United States Standard Industrial Classification (SI C) codes and corresponding North American Industry Classification System (NAI CS) 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, 325 211, 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 I CR that is recorded and/or reported is required b y National Emission Standards for Hazardous Air Pollutants for Commercial Ethyl ene Oxide Sterilization and Fumigation Operations (40 CFR Part 63, Subpart O). A source must make the following reports:6 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) Notificati on 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 exc ess 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 sy stems 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 ye ars 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 ty

pe of monitoring equipment has significantl y reduced the burden associated with monitoring and recordkeeping. In addition, some regulatory agencies are setting up electronic reporting sy stems to allow sources to report electronicall y which is reducing the reporting burden. However, electronic reporting sy stems are still not widely used b y the regulatory

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

(ii) Respondent Activities (iii)7 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 sy stems 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 sy stems for the purpose of processing and maintaining information. Develop, acquire, install, and utilize technology and sy stems for the purpose of disclosing and providing information. All monitoring sy stems and equipment must be installed, operational, and properl y calibrated before the performance test. Adjust existing way s 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 ty pe of monitoring equipment has significantl y 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 an d reports, including performance test reports, excess emissions reports, required to be submitted by industry

. Audit facility

records. Input, anal yz e, and maintain data in the Air Facility Sy stem (AFS). 5(b) Collection Methodology and Management Foll owing notification of startup, the reviewing authority might inspect the source to determine whether the pollution control devices are properl y installed and operational. P erformance test reports are used b y the Agency to discern a source’s initial capabi lity 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 and8

enforcement programs. The semiannual reports are used for problem identification, as a check on source operation and maintenance, and for compliance determinations.
In formation 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 l ocal and state regulatory a gencies, EPA regional offices and EPA headquarters. EPA and its delegated Authorities can edit, store, retrieve and anal yz e the data. The records required b y this regulation must be retained by the owner or operator for five ye ars. 5(c) Small Entity Flexibility A majority

of the affected facilities are primaril y large entities (e.g., large businesses). The exact number of small entities affected b y this rule could not be determined based on review of available document s, including the Ethyl ene 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 ty pe of control equipment employed, the recordkeeping and reporting requirements are the same for both small and large entities. The Agenc y 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

f or each information collection activity w ithin this request is shown below in Table 1: Annual Respondent Burden and Cost

- NESHAP for Commercial Ethyl ene 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 rec ordkeeping and reporting requirements applicable to the industry for the subpart included in this I CR. 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 unle ss 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 T able 1). These9

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 I CR 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 L abor 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 b y 110 percent to account for the benefit packages available to those emplo ye d by private industry

. (ii) Estimating Capital/Startup and Operation and Maintenance Costs The ty pes 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)
Com puter equipment and gas chromatograph used to continuously mo nitor EO emissions to aeration ro om 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 I CR are $583,000. Thi s is the total of column G.
The average annual cost for capital/startup and operation and maintenance costs to industry over the next three ye ars of the I CR is estimated to be $648,000. 6(c) Estimating Agency Burden and Cost The only costs to the Agen cy

are those costs associated with anal ys is 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 hourl y labor rate as follows:

Managerial $62.27 (GS

- 13, Step 5, $38.9 2 + 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 b y 60 percent to account for the benefit packages available to government emplo ye es
. 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 currentl y subject to the standard. It is estimated that two additional sources per year will become subject to the regulation in the next three ye ars. However, we estimate that 10 percent or approximately 12 facilities will use onl y l imited 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 ye ars covered b y 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 12011 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, co lumn D is subtracted. As shown above, the average Number of Respondents over the three

- ye ar period of this I CR is 119. The total number of annual responses per ye ar 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 Repo rts (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 Ethyl ene 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, respectivel y, 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 Ethyl ene 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 Maintenance12

(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. S ee 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 la bor hours to respondents in this I CR compared to the previous ICR. This is due to two considerations: ( 1) the regulations have not changed over the past three ye ars 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 i s due to the u

pdating 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, o r 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 s ys tems for the purposes of collecting, validating, and verifying information, processing and maintaining information, and disclosing and providing information; adjust the existing way s to comply with any previously

applicable instructions and requirements; train per sonnel 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 s uggested methods for minimizing respondent burden, including the use of automated collection techniques, EPA has established a public docket for this IC R under Docket ID Number EPA

–HQ

–OECA

–2009

–0392. An electronic ve rsion 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 do cuments in the public docket that are available electronically . When in the sy stem , 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 In formation Center in the EPA Docket Center (EPA/DC), EPA West, Room 3334, 130113

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 holiday s. 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 S treet, 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 b ecause no statistical methods were used in collecting this information.14 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/

Yeara 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 Testc 200 1 200 2 400.00 20.00 40.00 460.00 $43,511.00 Repeat Performance Testc, 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/Reconstructione 2 1 2 2 4.00 0.20 0.40 4.60 $435.11 Notification of Actual Startup e 2 1 2 2 4.00 0.20 0.40 4.60 $435.11 Notification of Initial Performance Test e 2 1 2 2 4.00 0.20 0.40 4.60 $435.11 Notification of Compliance Status e 2 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 f 6 1 6 0.1 0.60 0.03 0.06 0.69 $65.27 Report for Alternative Method/Monitoring f 6 1 6 0.1 0.60 0.03 0.06 0.69 $65.27 Report of Performance Test g 24 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 $382,81015 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 Informationl 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 av erage number of respondents that will be subject to the rule will be the 119 existing respondents. There will be two additio nal 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). T hese rates are from the United States Department of Labor, Bureau of Labor Statistics, March 2009, "Table 2. Civili an workers, by Occupational and Industry group." The rates are from column 1, "Total compensation." T he rates have been increased by 110 percent to account for the benefit packages available to those em ployed by private industry. T his ICR assumes that M anagerial 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 ne w respondents two hours to w rite each notification report. f) It is assumed that 10 percent of new facilities will take 6 hours to w rite 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 require d 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.16 Table 2: Average Annual EPA Burden
- NESHAP for Commerc ial 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/

Yeara 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 Facilityc 40 1 40 2 80.00 4.00 8.00 92.00 $4,145.96 Repeat Performance Tests New or Modified Facilityd 136 1 136 0.4 54.40 2.72 5.44 62.56 $2,819.25 Report Review New or Modified Facility Notification of Applicabilitye 2 1 2 2 4.00 0.20 0.40 4.60 $207.30 Notification of Construction/Reconstructione 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 Teste 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 Testi 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 exi sting 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%). T hese rates are from the Office of Personnel Management (OPM), 2010 General Schedule, which excludes locality rates of p ay
. T h e rates have been increased by 60 percent to account for the benefit packages available to government employees. This ICR assumes that Clerical hours are 1 0 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. T we nty 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 noncomp liance.