Document ID: EPA-HQ-OECA-2007-0049-0003
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2007-12-11T05:00Z

SUPPORTING STATEMENT

ENVIRONMENTAL PROTECTION AGENCY

	

NSPS for Hospital/Medical/Infectious Waste Incinerators 

1.  Identification of the Information Collection

1(a)  Title of the Information Collection

NSPS for Hospital/Medical/Infectious Waste Incinerators (40 CFR part 60,
subpart Ec) (Renewal)

1(b)  Short Characterization/Abstract

The New Source Performance Standards (NSPS) for
Hospital/Medical/Infectious Waste Incinerators (HMIWI), 40 CFR part 60,
subpart Ec, were promulgated on September 15, 1997.  These standards
apply to HMIWIs for which construction commenced after June 20, 1996, or
for which modification commenced after the effective date of the NSPS. 
Reporting and recordkeeping requirements differ for HMIWI burning
hospital waste and/or medical/infectious waste; for combustors co-firing
hospital waste and/or medical/infectious waste with other fuels; and for
incinerators burning only pathological, low-level radioactive, and/or
chemotherapeutic waste.  For this reason, reporting and recordkeeping
requirements are described separately for HMIWI burning hospital waste
and/or medical/infectious waste and for co-fired combustors and
incinerators burning only pathological, low-level radioactive, and/or
chemotherapeutic waste. This information is being collected to determine
compliance with 40 CFR part 60, subpart Ec and 40 CFR part 60, subpart A
( General Provisions.

The Emission Guidelines (EG) and Compliance Times for HMIWIs, 40 CFR
part 60, subpart Ec, were promulgated on September 15, 1997.  These
standards apply to existing HMIWIs for which construction commenced on
or before June 20, 1996.  The reporting and recordkeeping requirements
for existing HMIWIs regulated by 40 CFR Part 60, Subpart Ec are covered
in Information Collection 1899 and Office of Management and Budget (OMB)
Control Number 2060-0422.  HMIWIs built after June 20, 1996, are not
subject to the subpart Ec guidelines; they are considered new sources
and are subject to the standard.

In general, all NSPS 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 the
standard.  The owners or operators must also submit annual and
semiannual reports.

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
two 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 nine sources are currently subject to the standard, and it
is estimated that an additional one source per year will become subject
to the regulation in the next three years.  It if further assumed that
one additional source per year will become subject to the standard due
to the reconstruction of an existing affected facility for an average of
nine sources over the next three years.  Based on our consultations with
industry representatives, there is an average of one affected facility
at each plant, and that each plant site has only one respondent (i.e.,
the owner/operator of the plant site).

There are approximately one hundred hospital/medical/infectious waste
incinerators in the United States, which are all publicly owned and
operated by the hospital/medical/infectious waste incinerators industry,
of these only nine facilities built after June 20, 1996 are subject to
NSPS subpart Ec.  None of the nine plants 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.  You
can find the burden to the “Affected Public” listed below in Table
1: Annual Industry Burden and Cost - NSPS for
Hospital/Medical/Infectious Waste Incinerators (40 CFR Part 60, Subpart
Ec).  The Federal government burden does not include work performed by
Federal employees only work performed by contractors, which could be
found listed below in Table 2: Average Annual EPA Burden - NSPS for
Hospital/Medical/Infectious Waste Incinerators (40 CFR Part 60, Subpart
Ec).

The Office of Management and Budget (OMB) approved the currently active
ICR without any “Terms of Clearance.”

2.  Need for and Use of the Collection

2(a)  Need/Authority for the Collection

The EPA is charged under section 111 of the Clean Air Act (CAA), as
amended, to establish standards of performance for new stationary
sources that reflect: 

. . . application of the best technological system of continuous
emissions reduction which (taking into consideration the cost of
achieving such emissions reduction, or any non-air quality health and
environmental impact and energy requirements) the Administrator
determines has been adequately demonstrated.  Section 111(a)(l).

The Agency refers to this charge as selecting the best demonstrated
technology (BDT).  Section 111 also requires that the Administrator
review and, if appropriate, revise such standards every four years. 

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, pollutant from dioxins/furans
(CDD/CDF), particulate matter (PM), carbon monoxide (CO), lead (Pb),
cadmium (Cd), hydrochloric acid (HCI), sulfur dioxide (SO2), nitrogen
oxides (NOx), and mercury (Hg) emissions from HMIWIs causes or
contribute to air pollution that may reasonably be anticipated to
endanger public health or welfare.  Therefore, the NSPS was promulgated
for this source category at 40 CFR part 60, subpart Ec.

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 standard. 
Continuous emission monitors are used to ensure compliance with the
standard at all times.  During the performance tests, 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 ensure that the pollution control devices are properly installed and
operated, that leaks are being detected and repaired, and that the
standard is being met.  The performance test may also be observed.

The required semiannual and quarterly reports are used to determine
periods of excess emissions, identify problems at the facility, verify
operation/maintenance procedures, and for compliance determinations.

3.  Nonduplication, Consultations, and Other Collection Criteria

The requested recordkeeping and reporting are required under 40 CFR part
60, subpart Ec. 

3(a)  Nonduplication

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 (72 FR 10735) on March 9, 2007. 
No comments were received on the burden published in the Federal
Register.

3(c)  Consultations

In estimating the affected number of sources, the growth rate, and the
accuracy of other data for hospital/medical/infectious waste
incinerators subject to this standard, we contacted Wheelabrator Falls
Incorporated, Mr. Alan Lewis, at (215) 736-1760, the National Solid
Waste Management Association (NSWMA), Ms. Alice Jacobson, at (202)
244-4700, and York County Waste/York County Resources, Mr. Jonathan
Beuschlein, at (717) 845-1066.  We also referenced the most recent ICR,
and used other internal resources to obtain the most recent data
available.  We reviewed information available from the Online Tracking
Information System (OTIS) which is the primary source of information
regarding the number of existing sources.  OTIS data was used in
conjunction with industry consultation to verify the number of sources
and the industry growth rate.

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.

 	

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

None of the reporting or recordkeeping requirements contain sensitive
questions.

4.  The Respondents and the Information Requested

4(a)  Respondents/SIC Codes

The respondents to the recordkeeping and reporting requirements are
stationary gas turbines.  The United States Standard Industrial
Classification (SIC) codes which correspond to the North American
Industry Classification System (NAICS) code could be found in the
following table:

40 CFR part 60, subpart Ec	SIC Codes	NAICS Codes

General Medical and Surgical Hospitals	8062 	622110

	8069	622110

Psychiatric and Substance Abuse Hospitals	8063	622210

	8069	622210

Continuing Care Retirement Communities	8051	623311

	8052	623311

	8059	623311

Nursing Care Facilities	8051	623110

	8052	623110

	8059	623110

Residential Mental Retardation Facilities	8051	623210

	8052	623210

	8059	623210

Specialty (except Psychiatric and Substance Abuse) hospitable	8069
622310

Research and Development in the Physical , Engineering, and Life
Sciences	8731	541710

Hazardous Waste Treatment and Disposal	4953	562211

Materials Recovery Facilities	4953	562920

Other Non-hazardous Waste Treatment and Disposal	4953	562219

Solid Waste Combustors and Incinerators	4953	562213

Solid Waste Landfill	4953	562212

Veterinary Services	0741	541940

	0742	541940

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

In this ICR, all the data recorded or reported is required by the New
Source Performance Standards for Hospital/Medical/Infectious Waste
Incinerators (40 CFR part 60, subpart Ec).

A source must make the following reports:

Notifications Reports

Statement if intent to construct/modify	60.58c(a)(1)(i)

Notification and application of construction or modification	60.58c(a),
60.7(a)

Notification of actual startup	60.7(a)

Notification of type(s) of waste to be combusted	60.58c(a)(2)(i)

Notification of HMIWI capacity	60.58c(a)(2)(ii)

Documents produced as a result of the siting requirements
60.58c(a)(1)(iii), 60.54c(c)

Waste reduction plan	60.58c(a)(2)(i)

Notification of initial performance tests (PM, stack opacity, fugitive
ash emissions, CDD/CDF, HCI, CD, Pb, Hg)	60.58c(c)(1), 60.8(d)

Notification of site-specific operating parameters or changes
60.58c(c)(2), 60.7(a)

Notification of initial performance tests (PM, stack opacity, fugitive
ash emissions, CDD/CDF, HCI, Cd, Pb, Hg)	60.58c(c)(1), 60.8(a)

Report of site-specific operating parameters	60.58c(d)(1)

Report of annual and semiannual emissions or operating parameter
exceedances, malfunctions, and periods for which data on emissions/
operating parameters were not obtained	60.58c(d), 60.58(e), 60.7(c)

Report of no excess emissions	60.59(d)(7), 60.7(c)

Petition for site-specific operating permits (if applicable)
60.58c(a)(iii)

Report of exceedances	60.58c(b)(5)

Report of performance test	60.58c(d)(6)

A source must keep the following records:

Recordkeeping 

Retention of records for two-years	60.58c(b)

Records of startup. Shutdown, or malfunction	60.7(b)

Documentation produced as a result of siting requirements	60.58c(b)(7)

Records of persons completing review of HMIWI operating manual
60.58c(b)(8)

Records if operators completing operator training course and
qualification requirements	60.58c(b)(9), 60.58c(b)(10)

Records of annual testing of fugitives ash emissions	60.58c(b)(2)(ii)

Records of process and control device operating parameters
60.58c(b)(2)(xv), 60.8(f)

Records of emissions or operating parameter exceedances and periods for
which data on emissions/operating parameters were not obtained
60.58c(b)(3), 60.8(f)

Records of initial, annual and subsequent performance tests
60.58c(b)(6), 60.8(f)

Records of calibration of any monitoring devices	60.58c(b)(11)

Records of types and amounts of materials charged for co-fired
combustors and for incinerators burning only pathological, low-level
radioactive, and/or chemotherapeutical waste	60.50c(c)

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 15 percent of the respondents use
electronic reporting.

Respondent Activities

Read instructions.

Install, calibrate, maintain, and operate continuous monitoring system
(CMS) or continuous emission monitoring systems for measuring and
recording the missions of pollutants from an affected facility.

Perform initial performance test, Reference Methods 1, 3, 3A, 3B, 9, 10,
10B, 22, 23, 26, 26A, 29, and repeat performance tests if necessary.

Write the notifications and reports listed above.

Enter information required to be recorded above.

Develop site-specific operating parameters.

Develop waste reduction plan.

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.

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.

Transmit, or otherwise disclose the information.

	Currently, sources are using monitoring equipment that provides
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.

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 Online Tracking Information
System (OTIS).

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 OTIS which is
operated and maintained by the EPA Office of Compliance.  OTIS is an EPA
database for the collection, maintenance, and retrieval of compliance
data for approximately 125,000 industrial and government-owned
facilities.  EPA uses 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 or
operator for two years.

5(c)  Small Entity Flexibility

The majority of the respondents are large entities (i.e., large
businesses).  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.

5(d)  Collection Schedule

The specific frequency for each information collection activity within
this request is shown in Table 1: Annual Industry Burden, NSPS for
Hospital/Medical/Infectious Waste Incinerators (40 CFR part 60, subpart
Ec).

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 6,617
(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 NSPS 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	$105.86 ($50.41 + 110%)   

Technical	$92.61   ($44.10 + 110%)

Clerical	$45.32   ($21.58 + 110%)

These rates are from the United States Department of Labor, Bureau of
Labor Statistics, December 2006, Table 2. Civilian Workers, by
occupational and industry group.  The rates are from column 1, Total
compensation.  The rates have been increased by 110% to account for the
benefit packages available to those employed by private industry.

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

The only cost to the existing regulated respondents resulting from
information collection activities required by the subject standard is
labor costs.  For existing regulated respondents, there is no
capital/startup costs required for the purchase or the installation of
equipment, because they comply by employing pollution prevention
measures.  New respondents have capital costs associated with the
purchase of the equipment necessary for compliance, as well as operation
and maintenance costs.  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)

CMS	$2,377	1	$2,377	$2,800	9	$25,200

The total capital/startup costs to new respondents for this ICR are
$2,000 (rounded).  This is the total of column D in the above table.

The total operation and maintenance (O&M) costs for this ICR are $25,000
(rounded).  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 $27,000 (rounded).

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 $27,419.

This cost is based on the average hourly labor rate as follows:

	Managerial	$58.18 (GS-13, Step 5, $36.36 + 60%) 

	Technical	$43.17 (GS-12, Step 1, $26.98 + 60%)

	Clerical	$23.36 (GS-6, Step 3, $14.60 + 60%)

These rates are from the Office of Personnel Management (OPM) (2007
General Schedule( which excludes locality rates of pay.  The rates have
been increased by 60% to account for the benefit packages available to
government employees.  Details upon which this estimate is based appear
in Table 2: Average Annual EPA Burden, NSPS for
Hospital/Medical/Infectious Waste Incinerators (40 CFR Part 60, Subpart
Ec), below.

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

	

Based on our research for this ICR, on average over the next three
years, approximately nine existing respondents will be subject to the
standard.  It is estimated that one additional respondent will become
subject over the next three years.

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 1 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	7	0	1	8

2	2	8	0	1	9

3	2	9	0	1	10

Average	2	8	0	1	9

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

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 nine.

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

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 intent to construct	1	1	n/a	1

Notification of actual startup 	1	1	n/a	1

Notification of waste to be combusted	1	1	n/a	1

Notification of HMIWI capacity	1	1	n/a	1

Notification of initial performance tests	1	1	n/a	1

Notification of initial CMS demonstration	1	1	n/a	1

Initial report for the site selection analysis	1	1	n/a	1

Waste reduction plan	1	1	n/a	1

Report of initial performance test	1	1	n/a	1

Notification of exemption claimed	1	1	n/a	1

Annual report	8	1	n/a	8

Semiannual reports	8	2	n/a	16

	Total	34

The number of total respondents is nine.

The number of Total Annual Responses is 34.  This is the number in
column E of the Respondent Universe and Number of Responses per year in
table above.

The total annual labor costs are $656,312.  Details regarding these
estimates may be found in Table 1: Annual Industry Burden, NSPS for
Hospital/Medical/Infectious Waste Incinerators (40 CFR Part 60, Subpart
Ec), below.

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 costs are $656,312.  Details regarding these
estimates may be found in Table 1. Annual Respondent Burden and Cost:
NSPS for Hospital/Medical (40 CFR part 60, subpart Ec), below. 
Furthermore, the annual public reporting and recordkeeping burden for
this collection of information is estimated to average 195 hours per
response.

The total annual capital/startup and O&M cost to the regulated entity
are $27,000.

(ii) The Agency Tally

The average annual Agency burden and cost over next three years is
estimated to be 657 labor hours at a cost of $27,419.  See Table 2.
Annual Agency Burden and Cost: NSPS for Hospital/Medical/Infectious
Waste Incinerators (40 CFR part 60, subpart Ec), below.

6(f)  Reasons for Change in Burden

There is an increase in the total estimated burden as currently
identified in the OMB Inventory of Approved Burdens.  This increase is
not due to any program changes.  There is an increase in the number of
new sources, also a revised hourly labor rate.

There is also an increase in the capital/startup and operations and
maintenance (O&M) cost which is due to an increase in the number of new
sources.

6(g)  Burden Statement

The annual public reporting and recordkeeping burden for this collection
of information is estimated to average 195 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’s 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-2007-0049.  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 content of the docket, and to
access those documents in the public docket that are available
electronically.  When in the system, select “search” than 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, 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
Enforcement and Compliance Docket and Information Center Docket 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, DC 20503, Attention: Desk Officer for EPA.  Please
include the EPA Docket ID Number EPA-HQ-OECA-2007-0049 and OMB Control
Number 2060-0363 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 – NSPS for
Hospital/Medical/infectious Waste Incinerators (40 CFR Part 60, Subpart
Ec)

 	(A)	(B)	(C)	(D)	(E)	(F)	(G)	 (H) 

 Burden item 	Person- hours per occurrence	No. of occurrences per
respondent per year	Person- hours per respondent per year (C=AxB)
Respondents per year (a)	Technical person- hours per year (E=CxD)
Management person-hours per year (Ex0.05)

	Clerical person-hours per year 

(Ex0.1)

	Cost ($) (b) 

1. Applications	N/A	 	 	 	 

	  

2. Survey and Studies	N/A	 	 	 	 

	  

3. Reporting requirements	 	 	 	 	 

	  

    Non-pathological HMIWI

    A. Read instructions	1	1	1	1	1	0.05	0.1	$102.43

    B. Required activities

       Initial performance test for CMS c	13	1	13	1	13	0.65	1.3
$1,331.66

       Repeat performance test CMS c	13	1	13	0.2 d	2.6	0.13	0.26	$266.33

   Development of operating information e	160	1	160	1	160	8	16
$16,389.60

       Annual update of operating information f	20	1	20	8 g	160	8	16
$16,389.60

       Review of operating information with

       each operator h	8	2	16	9	144	7.2	14.4	$14,750.64

    C.  Create information	See 3B

	    D.  Gather existing information	See 3B

	    E.  Write report

    Non-pathological HMIWI

         Notification of intent to construct	2	1	2	1	2	0.1	0.2	$204.87

         Notification of actual startup	2	1	2	1	2	0.1	0.2	$204.87

         Notification of waste to be combusted	2	1	2	1	2	0.1	0.2	$204.87

         Notification of HMIWI capacity	2	1	2	1	2	0.1	0.2	$204.87

         Notification of initial performance test	2	1	2	1	2	0.1	0.2
$204.87

         Notification of initial CMS

         demonstration	2	1	2	1	2	0.1	0.2	$204.87

         Initial report for the site selection

         analysis i	460	1	460	1	460	23	46	$47,120.10

         Waste reduction plan j	160	1	160	1	160	8	16	$16,389.60

        Report of initial performance test k	40	1	40	1	40	2	4	$4,097.40

        Report of initial CMS demonstration	See 3B

	        Semiannual reports l	74	2 n	148	8 m	1,184	59.2	118.4
$121,283.04

        Annual reports	64	1 n	64	8	512	25.6	51.2	$52,446.72

Pathological and co-fired combustors

        Notification of relative amounts of

        hospital, medical/infectious and other

        waste charged	2	1	2	8	16	0.8	1.6	$1,638.96

        Notification of exemption claim	2	1	2	8 o	16	0.8	1.6	$1,638.96

    F.  Time to enter information

     (Non-pathological HMIWI)

        Records of startup, shutdown or

        malfunction	2	52	104	9	936	46.8	93.6	$95,877.16

        Records of persons completing review	2	2	4	9	36	1.8	3.6
$3,687.66

        Records of annual testing fugitive

        emissions	See 3E

	        Records of process and control device	1.5	52	78	9	702	35.1	70.2
$105,350.54

        Records of CMS operations and

        maintenance	0.2	272 q	54.4	9	489.6	24.48	48.96	$50,152.18

        Records of emissions exceedances	1.5	52	78	9	702	35.1	70.2
$105,350.54

        Records of annual compliance tests	See 3E

	5.  Recordkeeping requirements

    A.  Read instructions	See 3A

	    B.  Plan activities	N/A

	    C.  Implement activities	N/A

	    D.  Develop record system	N/A

	    E.  Time to enter information

  Non-pathological HMIWI

Documents produced as a result of

siting requirements	See 3E

	        Records of operators training

        completion	2	2 h	4	1	4	0.2	0.4	$409.74

    Records of HMIWI qualified operators	2	2 h	4	1	4	0.2	0.4	$409.74

    Records of initial performance test	See 3E

	    F.  Time to train personnel	N/A

	    G. Time for audits	N/A

	Subtotal

	5,754.2	287.71	574.62	$656,311.82

TOTAL ANNUAL BURDEN AND COST (rounded)

6,617

  $656,312

Assumptions:

a.  We have estimated that an average of  nine facilities have been
built or reconstructed after June 20, 1996, and therefore, are subject
to NSPS subpart Ec.  It is estimated that there are eight existing
respondents and one additional respondent over the next three years.

b.  This ICR uses the following labor rates: $105.86 per hour for
Executive, Administrative, and Managerial labor; $92.61 per hour for
Technical labor, and $45.32 per hour for Clerical labor.  These rates
are from the United States Department of Labor, Bureau of Labor
Statistics, December 2006, “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.

c.  We have assumed that it will take thirteen hours to perform a CMS
performance test.

d.  We have assumed that 20 percent of initial performance tests must be
repeated due to failure.

e.  Assume it will take 160 hours to develop the operating information.

f.   Assume it will take 20 hours to update the operating information
each year. 

g.  This activity will not be performed for the first year of a new
source.

h.  Assume it will require two operators at each facility.

i.  Assume it will take 460 hours to develop the site selection
analysis.

j.  Assume it will take 160 hours to develop a waste reduction plan.

k.  Assume it will take 40 hours to review report of initial performance
test.

l.  Assume it will take 74 hours to prepare semiannual which includes a
compilation of the CMS operations parameters.

m.  Respondents must submit semiannual reports.

n.  An annual report is submitted once per year and demonstrates the
overall compliance status of an affected facility over a two-year
period.  Semiannual reports comprised of detail operation parameter
information, exceedances and other data are submitted twice per year.

o.  Assume that an additional eight sources (pathological and co-fired
combustors) are also projected each year, but are considered exempt from
the rule.  It is assumed that there will be one affected facility per
respondent.

p.  The pathological combustors would be required to keep records on a
quarterly basis of the period of time when it applies, and the co-fired
combustors would be required to keep records of the amount of hospital
waste, medical/infectious waste and other fuels and waste to be
combusted, and the weight of the waste combusted on a quarterly basis.

q.  Assume that it takes 272 days-per-year to record CMS operation and
maintenance.

Table 2:  Average Annual EPA Burden – NSPS for
Hospital/Medical/infectious Waste Incinerators (40 CFR Part 60, Subpart
Ec)

 	(A)	(B)	(C)	(D)	(E)	(F)	(G)	 (H) 

Activity 	EPA person- hours per occurrence	No. of occurrences per plant 

per year	EPA person- hours per plant per year (C=AxB)	Plants per year
(a)	Technical person- hours per year (E=CxD)	Management person-hours per
year (Ex0.05)

	Clerical person-hours per year 

(Ex0.1)

	Cost ($) (b) 

Activity

 	 	 	 

	  

1.  Attend initial performance test	32	1	32	0.08c	2.56	0.128	0.256
$123.94

2.  Repeat performance test

     A.  Retesting preparation	12	1	12	0.2d	2.4	0.12	0.24	$116.20

     B.  Attend retesting	32	1	32	0.1e	3.2	0.16	0.32	$154.92

3.  Excess emissions	32	1	32	0.1f	3.2	0.16	0.32	$154.92

4.  Report review

     Review notification of intent to construct	2	1	2	1	2	0.1	0.2	$96.83

     Review notification of actual startup	2	1	2	1	2	0.1	0.2	$96.83

 Review notification of type(s) of waste to

 be combusted	2	1	2	1	2	0.1	0.2	$96.83

     Review notification of HMIWI capacity	2	1	2	1	2	0.1	0.2	$96.83

     Review notification of initial performance

     test	8	1	8	1	8	0.4	0.8	$387.32

     Review notification of initial CMS

     demonstration	5	1	5	1	5	0.25	0.5	$242.07

     Review notification of relative amounts of 

     hospital, medical/infectious, and other

     waste charged for pathological and co-fired

     combustors	2	1	2	8g	16	0.8	1.6	$774.64

     Review notification of exemption claim for

     pathological and co-fired combustors	2	1	2	8g	16	0.8	1.6	$774.64

     Review study addressing siting requirements	24	1	24	1	24	1.2	2.4
$1,161.96

     Review waste reduction plan	8	1	8	1	8	0.4	0.8	$387.32

     Review report of initial performance test	42h	1	42	1	42	2.1	4.2
$2,033.43

     Review report of initial CMS demonstration	64i	1	64	1	64	3.2	6.4
$3,098.56

     Review notification of exemption claim	1	1	1	1	1	0.05	0.1	$48.42

     Review performance tests results	18	1	18	8j	144	7.2	14.4	$6,728.82

     Review annual report	4	1	4	8	32	1.6	3.2	$1,549.28

Review semiannual reports	12	2 k	24	8j	192	9.6	19.2	$9,295.68

TOTAL ANNUAL BURDEN AND COST (rounded)

657

$27,419

Assumptions:

a.  We have estimated that an average of  nine facilities have been
built or reconstructed after June 20, 1996, and therefore, are subject
to NSPS subpart Ec.  It is estimated that one additional respondent will
become subject over the next three years.

b.  The cost is based on the following labor rate which incorporates a
1.6 benefits multiplication factor to account for government overhead
expenses.  Managerial rates of $58.18 (GS-13, Step 5, $36.36x1.6),
Technical rate of $43.17 (GS-12, Step 1, $26.98 x 1.6), and Clerical
rate of $23.36 (GS-6, Step 3, $14.60 x 1.6).  These rates are from the
Office of Personnel Management (OPM) “2007General Schedule” which
excludes locality rates of pay.

c.  Each year a total of one HMIWI performs an initial performance test.
 It is assumed that EPA personnel will attend eight percent of these
tests.

d.  It is assumed that 20 percent will fail the initial performance
test, and will have to repeat the test.

e.  Assume 10 percent of retests are attended by EPA personnel.         
                                      

f.  Assume 10 percent of the affected facilities are required to retest
as a result of excess emissions, with 10 percent of these tests being
attended by EPA personnel.

g.  Assume that an additional six sources (pathological and co-fired
combustors) are also projected each year, but are considered exempt from
the rule.  It is assumed that there will be one affected facility per
respondent.

h.  Assume it takes six persons-hours per report to review each
pollutant.  For initial tests there are seven pollutants that are
subject to this rule (PM, CO, CDD/CDF, HCI, metals, stack opacity, and
fugitive emissions.

i.  Assume it takes eight person-hours per report to review each CMS
demonstration.  There are eight CMS that are subject to this rule
(temperature, gas flow, charge weight, pH, liquid flow, pressure drop,
carbon flow, and lime flow).

j.  This activity will not be performed for the first year of a new
source.

k.  Respondents must submit semiannual reports.

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