Document ID: EPA-HQ-OECA-2009-0392-0003
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2010-05-19T04:00Z

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.

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.

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 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).

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:

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.

Respondent Activities

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 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 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. 

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

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

(Renewal)

 

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

(Renewal), (Continued)

 

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.

 Table 2: Average Annual EPA Burden - NESHAP for Commercial Ethylene
Oxide Sterilization and Fumigation Operations (40 CFR Part 63, Subpart
O) (Renewal)

 

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.

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.

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