Document ID: EPA-HQ-OECA-2007-0049-0002
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2007-11-08T05:00Z

SEQ CHAPTER \h \r 1 	SF-83 SUPPORTING STATEMENT

	ENVIRONMENTAL PROTECTION AGENCY

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

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 Ce, 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 Ce 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 Ce 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 will
maintain a file of these measurements, and retain the file for at least
five years following the date of such occurrence, measurements,
maintenance, corrective action, reports or 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 seven 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 is 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 seven sources over the next three years.  There are
approximately one hundred operating hospital/medical/infectious waste
incinerators in the United States.  Of these, only seven facilities
built after June 20, 1996, are considered new sources and are subject to
NSPS subpart Ec.  The average annual cost to industry over the next
three years of this Information Collection Request (ICR) is estimated at
$305,929.

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

This ICR is approved for three years.  When EPA resubmits the ICR for
renewal the agency should include a copy of the analysis of affected
facilities, which it conducted in 2000.

	EPA addressed the item of concern in the TOC as requested by OMB, and
supplied the information provided by the previous preparer.  The three
tables, numbered 5, 7, and 8, that the previous preparer forwarded were
used as the analysis of affected facilities in preparing the previous
ICR.  These can be found attached to the back of this supporting
statement and are: Table 5 - Compliance and Enforcement History for
Dioxins and Mercury Emissions from Municipal Waste Combustors Subject to
State Implementation Plans; Table 7 - Negative Declaration for
Hospital/Medical/Infectious Waste Incinerators; and Table 8 - States
Subject to the Federal Plan for Hospital/Medical/Infectious Waste
Incinerators.

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, dioxins/furans, particulate matter,
carbon monoxide, lead, cadmium, hydrochloric acid, sulfur dioxide,
nitrogen oxides, and mercury emissions from HMIWIs cause or contribute
to air pollution that may reasonably be anticipated to endanger public
health or welfare.  Therefore, the NSPS were promulgated for this source
category at 

40 CFR part 60, subpart Ec.

	2(b)  Practical Utility/Users of the Data

	The control of emissions of 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) requires not only the installation of properly designed
equipment, but also the operation and maintenance of that equipment. 
Emissions of CDD/CDF, PM, CO, Pb, Cd, HCI, SO2, NOx, and Hg from HMIWIs
are the result of the operation of the affected facilities.  The subject
standards are achieved by the reduction of pollutant emissions using
control technology and/or leak detection and repair procedures.

	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 and/or leaks are being detected and
repaired and the regulations are being met.  Performance test reports
are needed as these are the Agency's records of a source's initial
capability to comply with the emission standards, and serve as a record
of the operating conditions under which compliance was achieved. 
Operating conditions monitored include the highest maximum and lowest
minimum operating parameters and exceedances of emission rates or
operating parameters.

	The semiannual reports are used for problem identification, as a check
on source operation and maintenance, and for compliance determinations. 
Annual reports are also required, this will include: 1) site-specific
operating parameters; 2) highest and lowest operating parameters; 3)
time performance tests were conducted and the test results; 4) statement
of no exceedances occurring during the reporting period; and 5) any uses
of a bypass stack, the duration, reason for malfunction, and corrective
action taken.  The information generated by the monitoring,
recordkeeping and reporting requirements described in this ICR is used
by the Agency to ensure that facilities that are affected by the NSPS
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.  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 its own similar standards to
implement the Federal standards, a copy of the report submitted to the
state or a 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 (FR citation, e.g., 69 FR 29718)
on May 25, 2004.  No comments were received on the burden published in
the Federal Register.

	3(c)  Consultations

	For the information collection, we referenced the most recent ICR, and
accessed the most recent data available on the Air Facility System (AFS)
database as maintained by the Office of Compliance.  We reviewed
information available from the United States Census Bureau, and other
websites covering HMIWIs.  We also consulted with the preparer of the
previous ICR, the EPA’s Office of Air Quality Planning and Standards,
Information Transfer, the Program Integration Division, and Mr. Alan
Lewis, Wheelabrator Falls Incorporated, (215) 736-1760.

	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 is a useful
technique 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 1320.5.

	Affected entities must retain reports and records for five years under
40 CFR part 60, subpart Ec and 40 CFR part 60, subpart A - General
Provisions.

	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 (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
hospital/medical/infectious waste incinerators.  The United States
Standard Industrial Classification (SIC) code for the respondents
affected by the standards, which corresponds to the North American
Industry Classification System (NAICS) codes, are listed below for
source category description.

Standard (40 CFR Part 60, Subpart Ec)	SIC Codes	NAICS Codes

General Medical and Surgical Hospitals	8062 and 8069	622110

Psychiatric and Substance Abuse Hospitals	8063 and 8069	622210

Continuing Care Retirement Communities	8051, 8052 and 8059	623311

Nursing Care Facilities	8051, 8052 and 8059	623110

Residential Mental Retardation Facilities	8051, 8052 and 8059	623210

Specialty (except Psychiatric and Substance Abuse) Hospitals	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 Nonhazardous Waste Treatment and Disposal	4953	562219

Solid Waste Combustors and Incinerators	4953	562213

Solid Waste Landfill	4953	562212

Veterinary Services	0741 and 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

	All data in this ICR that are recorded and/or reported are required by
New Source Performance Standards for Hospital/Medical/Infectious Waste
Incinerators (40 CFR part 60, subpart Ec).

	A source must make the following reports:

Notification Reports	Standard Citation by Section

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

Notification and application of construction or modification	60.58c(a)
and 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) and 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) and 60.8(d)

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

Notification of initial performance tests (PM, stack opacity, fugitive
ash emissions, CDD/CDF, HCI, Cd, Pb, Hg)	60.58c(c)(1) and 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), 60.58c(e)
and 60.7(c)

Report of no excess emissions.	60.58c(d)(7) and 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 five-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 of operators completing operator training course and
qualification requirements	60.58c(b)(9), and 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) and 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) and 60.8(f)

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

	Currently, sources are using monitoring equipment that provides
automated parameter data, e.g., gases which contain particulate matter. 
Although personnel at the affected facility must 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 15 percent of
the respondents use electronic reporting.

		(ii)  Respondent Activities	

Respondent Activities

Read instructions.

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

Perform initial performance test, Reference Method 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 automated monitoring equipment that
provides parameter data.  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,
and 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 operated.  Performance test reports are used
by the Agency to discern a source’s initial capability to comply with
the emission standard.  Data and records maintained by the respondents
are tabulated and published for use in compliance and enforcement
programs.  The semiannual reports are used for problem identification,
as a check on source operation and maintenance, and for 

compliance determinations.

	Information contained in the reports is entered into the AFS which is
operated and maintained by EPA's Office of Compliance.  AFS is EPA’s
database for the collection, maintenance, and retrieval of compliance
data for approximately 125,000 industrial and government-owned
facilities.  EPA uses the 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 large entities (e.g., 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 requirements the minimum
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: 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
each of the subpart included in this ICR. The individual burdens are
expressed under standardized headings believed to be consistent with the
concept of burdens under the Paperwork Reduction Act.  Where
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 4,795
( 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	$95.32   ($45.39 + 110%)

Technical	$64.60   ($30.76 + 110%)

	Clerical	$40.09   ($19.09 + 110%)

These rates are from the United States Department of Labor, Bureau of
Labor Statistics, December 2003, “Table 10. Private industry, 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 cost associated with the information collection
activities in the subject standard(s) 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(s) 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	7	$19,600

	The total capital/startup costs for this ICR are $2,000 (rounded). 
This is the total of column D in the above table.  These costs are shown
on the OMB 83-I form in block 14(a), Total annualized capital/startup
costs.

	The total operation and maintenance (O&M) costs for this ICR are
$20,000 (rounded). This is the total of column G.  These costs are shown
on the OMB 83-I form in block 14(b), Total annual costs (O&M).

	The total respondent costs in block 14 have been calculated as the
addition of the capital/startup costs, and the annual operation and
maintenance costs.  The average annual cost for capital/startup and
operation and maintenance cost to industry over the next three years of
the ICR is estimated to be $22,000.  This cost is shown on the OMB 83-I
form in block 14(c), Total annualized cost requested.  The numbers in
block 14 of the OMB 83-I form are rounded to show the cost in thousands
of dollars.

	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'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 $20,031.

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

		Managerial	$54.66   (GS-13, Step 5, $34.16 x 1.6)

	Technical	$40.56   (GS-12, Step 1, $25.35 x 1.6)

	Clerical	$21.95   (GS-6,   Step 3, $13.72 x 1.6)

These rates are from the Office of Personnel Management (OPM) “2004
General Schedule” which excludes locality rates of pay.  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).

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

	Based on our research for this ICR, approximately seven existing
sources are currently subject to the standard.  It is estimated that an
additional one source per year will become subject to the standard in
the next three years.

	Number of respondents is calculated using the following table which
addresses the three years covered by this ICR.

Number of Respondents

	Respondents That Submit Reports	Respondents That Do Not Submit Any
Reports

	

Year	(A)

Number of New Respondents 1	(B)

Number of Existing Respondents	(C)

Number of Existing Respondents That Keep Records but Do Not Submit
Reports	(D)

Number of Existing Respondents That Are Also New Respondents 	(E)

Number of Respondents

(E=A+B+C-D)

1	2	5	0	1	6

2	2	6	0	1	7

3	2	7	0	1	8

Average	2	6	0	1	7

	1 New respondents include sources with constructed, reconstructed and
modified affected facilities.  In this standard existing respondents
submit initial notifications.

	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 seven.  This number appears on the OMB 83-I form in block
13(a), Number of respondents.

	Number of respondents is calculated using the following table which
addresses each of the three years covered by this ICR.

	

	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 test	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

CMS operating parameters	1	6	N/A	6

Results of annual performance tests	1	6	N/A	6

Annual and semiannual reports	6	2	N/A	12

	Total	33

The number of Total Annual Responses is 33.  This number is shown on the
OMB 83-I form in block 13(b), Total annual responses.

	The Total Hours Requested is shown on the OMB 83-I form in block 13(c).
 The total annual labor costs are $305,929.  The annual labor costs are
not shown on the OMB 83-I form. Details regarding these estimates may be
found in Table 1:  Annual Respondent Burden and Cost, NSPS for
Hospital/medical/Infectious Waste Incinerators (40 CFR part 60, subpart
Ec).

	The total annual capital/startup and O&M costs to the regulated
entities are $22,000.  This number is shown on the OMB 83-I form in
block 14(c), Total annualized cost requested.  The cost calculations are
detailed in Section 6(b)(iii), Capital/Startup vs. Operation and
Maintenance (O&M) Costs.

	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 Hours Requested is shown on the OMB 83-I form in block 13(c).
 The total annual labor costs are $305,929.  The annual labor costs are
not shown on the OMB 83-I form. Details regarding these estimates may be
found in Table 1:  Annual Respondent Burden and Cost, NSPS for
Hospital/Medical/Infectious Waste Incinerators (40 CFR part 60, subpart
Ec). Furthermore, the annual public reporting and recordkeeping burden
for this collection of information are estimated to average 145 hours
per response.

	The total annual capital/startup and O&M costs to the regulated entity
are $22,000.  This number is shown on the OMB 83-I form in block 14(c),
Total annualized cost requested.  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 are
estimated to be 486 labor hours at a cost of $20,031.  See Table 2: 
Annual Agency Burden and Cost, NSPS for Hospital /Medical/Infectious
Waste Incinerators (40 CFR Part 60, Subpart Ec).

	6(f)  Reasons for Change in Burden

	The increase in burdens from the most recently approved ICR is due to
an increase of one new source per year, by averaging the number of
respondents over the three-year period for the ICR.  In addition, a
revised hourly labor rate from the United States Department of Labor
partly contributed to the increase in burdens from the active ICR.

	6(g)  Burden Statement

	The annual public reporting and recordkeeping burden for this
collection of information are estimated to average 145 hours per
response.  Burdens 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
a respondent burden, including the use of automated collection
techniques, EPA has established a public docket for this ICR under
Docket ID Number OECA-2004-0015, which is available for public viewing
at the Enforcement and Compliance Docket and Information Center in the
EPA Docket Center (EPA/DC), EPA West, Room B102, 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 Enforcement and
Compliance Docket and Information Center is 

(202) 566-1752.  An electronic version of the public docket is available
through EPA Dockets (EDOCKET) at http://www.epa.gov/edocket.  Use
EDOCKET to submit or view public comments, access the index listing of
the contents of the public 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 above. 
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 

OECA-2004-0015 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)

	Burden item	(A)

Technical

Person-

hours per

occurrence	(B)   

No.  of

occurrences

per respondent

per year	(C)

Technical

Person-

hours per

respondent

per year

(C=AxB)	(D)

Respondents

per year a	(E)

Technical

person-

hours per

year

(E=CxD)	(F)

Management

person-hours per

year

(Ex0.05)	(G)

Clerical

person-

hours per year

(Ex0.1)	(H)

Total Cost per year  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	$73.38

  B.  Required Activities

       Initial Performance Test c               for CMS	13	1	13	1	13
0.65	1.3	$953.94

       Repeat  Performance

       Test CMS c	13	1	13	0.2d	2.6	0.13	0.26	$190.77

       Development of operating 

       information e	160	1	160	1	160	8	16	$11,740.00

       Annual update of operating           information f	20	1	20	6g	120
6	12	$8,805.00

       Review of operating                      information with each   
               operator h	8	2	16	7a	112	5.6	11.2	$8,218.00

  C.  Create Information		Included in 3B

  D.  Gather Existing information 	Included in3B

  E.  Write report

Non-pathological HMIWI

       Notification of intent to                 construct	2	1	2	1	2	0.1
0.2	$146.75

       Notification of actual startup	2	1	2	1	2	0.1	0.2	$146.75

       Notification of waste to be            combusted	2	1	2	1	2	0.1
0.2	$146.75

       Notification of HMIWI                 Capacity	2	1	2	1	2	0.1	0.2
$146.75

       Notification of initial                     performance test	2	1
2	1	2	0.1	0.2	$146.75

       Notification of initial CMS           demonstration	2	1	2	1	2	0.1
0.2	$146.75

       Initial report for the site                 selection analysis i
460	1	460	1	460	23	46	$33,752.50

       Waste reduction plan j	160	1	160	1	160	8	16	$11,740.00

       Report of initial                             performance test k
40	1	40	1	40	2	4	$2,935.00

       Report of initial CMS                    demonstration	Included
in 3B

       CMS operating parameters 	26	1	26	6g	156	7.8	15.6	$11,446.50

       Results of annual                           performance tests	40
1	40	6g	240	12	24	$17,610.00

       Semiannual reports	48	1n	48	6m	288	14.4	28.8	$21,132.00

       Annual Reports	24	1n	24	6	144	7.2	14.4	$10,566.00

Pathological and co-fired combustors

       Notification of relative                  amounts of hospital,   
                  medical/infectious, and                 other waste
charged	2	1	2	6o	12	0.6	1.2	$880.50

       Notification of exemption             claim	2	1	2	6o	12	0.6	1.2
$880.50

  F.  Time to enter information  

  (Non-pathological HMIWI)

       Records of startup,                        shutdown or
malfunction	2	52	104	7a	728	36.4	72.8	$53,417.00

       Records of persons                        completing review	2	2	4
7a	28	1.4	2.8	$2,054.00

       Records of annual testing              fugitive emissions
Included in3E

       Records of process and                  control device	1.5	52	78
7a	546	27.3	54.6	$40,062.75

       Records of CMS operations          and maintenance	0.2	272q	54.4
7a	380.8	       19.04	38.08	  $27,941.20

       Records of emissions                     exceedances	1.5	52	78	7a
546	27.3	54.6	  $40,062.75

       Records of annual                          compliance tests
Included in3E

	                                   

	5.  Recordkeeping                              Requirements

  A.  Read instructions	Included in3A

  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	Included in 3E

       Records of operators                     training completion	2	2h
4	1	4	0.2	0.4	$293.50

       Records of HMIWI                       qualified operators 	2	2h
4	1	4	0.2	0.4	$293.50

       Records of initial                           performance test 
Included in 3E

  F.  Time to train personnel	N/A

	  G.  Time for audits	N/A

	Subtotal Labor Burden

	4,169.4	208.47	416.94	$305,929.29

TOTAL LABOR  BURDEN AND COST (rounded)

	4,795	$305,929

Assumptions:

a  We have assumed that are approximately seven sources are subject to
the standard.  We have further assumed that one new source per year will
be equipped with wet/dry scrubbers from the date of renewal. 

b  This ICR uses the following labor rates:  $95.32 per hour for
Executive, Administrative, and Managerial labor; $64.60  per hour for
Technical labor, and $40.09 per hour for Clerical labor.  These rates
are from the United States Department of Labor, Bureau of Labor
Statistics, December 2003, “Table 10. Private industry, 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.

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 48 hours to report.  Testing and monitoring
requirements focuses primarily on three pollutants, particulate matter
(PM), carbon monoxide (CO), and hydrochloric acid (HCI).

m  Respondents must submit semiannual reports (See Footnote n).

n  Since the semiannual report coincides once a year with the annual
report and both reports include information on exceedances and periods
of which data were not obtained, the frequency of the semiannual report
is shown in the tables as only once per year instead of twice a year to
avoid double-counting.

o  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.

p  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)

	Burden item	(A)

Technical

Person

Hours Per

Occurrence	(B)   

Number  of

Occurrences

Per Year	(C)

Technical

Person Hours Per Plant Per

Year

(C=AxB)	(D)

Plants Per  Year a	(E)

Technical Hours 

Per Year

(E=CxD)	(F)

Management   Hours Per Year

(F=0.05xE)	(G)

Clerical

Hours Per

Year

(G=0.1xE)	(H)

Total

Cost, 

Per Yearb

Activity

1.  Attend initial performance test	32	1	32	0.08c	2.56	0.128	0.256
$116.45

2.  Repeat performance test

  A.  Retesting preparation	12	1	12	0.2d	2.4	0.12	0.24	$109.17

  B.  Attend retesting	32	1	32	0.1e	3.2	0.16	0.32	$145.56

3.  Excess emissions	32	1	32	0.1f	3.2	0.16	0.32	$145.56

4.  Report review

       Review notification of               intent to construct	2	1	2	1
2	0.1	0.2	$90.98

       Review notification of               actual startup	2	1	2	1	2	0.1
0.2	$90.98

       Review notification of               type(s) of waste to be      
          combusted	2	1	2	1	2	0.1	0.2	$90.98

       Review of notification of           HMIWI capacity	2	1	2	1	2	0.1
0.2	$90.98

       Review notification of               initial performance test	8	1
8	1	8	0.4	0.8	$363.90

       Review notification of               initial CMS demonstration	5
1	5	1	5	0.25	0.5	$227.45

       Review of notification of           relative amounts of          
         hospital, medical/                       infectious, and other 
                waste charged for                       pathological and
co-fired           combustors	2	1	2	6g	12	0.6	1.2	$545.86

       Review notification of               exemption claim for         
         pathological and co-fired           combustors	2	1	2	6g	12	0.6
1.2	$545.86

       Review study addressing           siting requirements	24	1	24	1
24	1.2	2.4	$1,091.71

       Review waste reduction             plan	8	1	8	1	8	0.4	0.8	$363.90

       Review report of initial              performance test	42h	1	42	1
42	2.1	4.2	$1,910.50

       Review report of initial              CMS demonstration	64i	1	6	1
64	3.2	6.4	$2,911.23

       Review annual report

       -  CMS operating                          parameters	4	1	4	6j	24
1.2	2.4	$1,910.50

       -  Results of performance              tests conducted during    
          the year	18	1	18	6j	108	5.4	10.8	$4,912.70

       - Review annual                           semiannual report of   
              emissions	8	2k, m	16	6j	96	4.8	9.6	$4,366.85

Subtotal 

	422.36	21.118	42.236	$20,031.12

Travel Expenses (rounded)  	 (1 person x .02 plant/yr x 2 day/plant x
$50 per diem) + ($400/round trip x .02 round trip/yr)                   
                    $0

TOTAL LABOR BURDEN and COST (rounded)

	486	$20,031

Assumptions:

a  We have assumed that are approximately seven sources are subject to
NSPS, subpart Ec.  We have further assumed that one new sources per year
will be equipped with wet/dry scrubbers from the date of renewal.

b  This cost is based on the following hourly labor rates times a 1.6
benefits multiplication factor to account for government overhead
expenses: $54.66 for Managerial (GS-13, Step 5, $34.16 x 1.6), $40.56
for Technical (GS-12, Step 1, $25.35 x 1.6) and $21.95 Clerical (GS-6,
Step 3, $13.72 x 1.6).  These rates are from the Office of Personnel
Management (OPM) “2004 General 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 attends 8 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 6 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 person-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 annual reports and semiannual reports (See
Footnote m).

l  Assume that 80 percent of respondents report no exceedances.

m  Since the semiannual report coincides once a year with the annual
report and both reports include information on exceedances and periods
of which data were not obtained, the frequency of the semiannual report
is shown in the tables as only once per year instead of twice a year to
avoid double-counting.