Document ID: EPA-HQ-OAR-2006-0534-0132
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2007-02-06T05:00Z

PART A OF THE SUPPORTING STATEMENT PRIVATE  

Hospital/Medical/Infectious Waste Incinerators

 listnum "WP List 1" \l 1 	Identification of the Information Collection

 listnum "WP List 1" \l 2 	Title and Number of the Information
Collection

	“Emission Guidelines for Hospital/Medical/Infectious Waste
Incinerators (40 CFR part 60, subpart Ce).”  This is a revision of an
existing Information Collection Request (ICR), which is assigned EPA
tracking number 1899.04 and Office of Management and Budget (OMB)
Control Number 2060-0422.

 listnum "WP List 1" \l 2 	Short Characterization

	The emission guidelines for hospital/medical/infectious waste
incinerators (HMIWI), 40 CFR part 60, subpart Ce, were promulgated on
September 15, 1997.  The guidelines apply to owners or operators of
HMIWI for which construction commenced on or before June 20, 1996 and
State regulatory agencies.  Subpart Ce requires States to develop plans
to implement the emission guidelines.  If approvable State Plans were
not developed, EPA was required to develop a Federal plan to implement
the emission guidelines in those States.  The Federal plan, 40 CFR part
62, subpart HHH, was promulgated on September 14, 2000.  States may
choose to impose more stringent requirements.  However, the burden
estimates in this ICR assume that the State Plans mirror the emission
guidelines.

	The emission guidelines require initial notifications, performance
tests, and annual and semiannual reporting.  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
guidelines.

	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
5 years following the date of such occurrence, measurements,
maintenance, corrective action, reports, and records.  All reports are
sent to the State authority with an approved plan.  In the event that
there is no such approved plan, the reports are sent directly to the
U.S. Environmental Protection Agency (EPA) Regional office.

	Reporting and recordkeeping requirements differ for incinerators
burning hospital/medical/infectious waste; for combustors co-firing
hospital/medical/infectious waste with other fuels; and for incinerators
burning only pathological, low-level radioactive, and/or
chemotherapeutic waste.  No exemption claims are expected over the next
3 years for co-fired combustors or for incinerators burning only
pathological, low-level radioactive, and/or chemotherapeutic waste.  For
this reason, no burden or cost has been estimated for these types of
units.  This information is being collected to determine compliance with
40 CFR part 60, subpart Ce.

	Based on an EPA Office of Air Quality Planning and Standards (OAQPS)
facility and emissions inventory effort for HMIWI, we have determined
that there are 72 existing HMIWI located at 67 different facilities. 
The emission guidelines regulate only existing sources; therefore, no
new respondents will become subject to the guidelines over the next 3
years.

 listnum "WP List 1" \l 1 	Need for and Use of the Collection

 listnum "WP List 1" \l 2 	Need/Authority for the Collection

	The EPA is required under Sections 111 and 129 of the Clean Air Act
(CAA), as amended, to establish guidelines for existing stationary
sources that reflect the maximum achievable control technology (MACT)
for achieving continuous emission reductions.  Section 111(d)(1) states:

	The Administrator shall prescribe regulations which shall establish a
procedure similar to that provided by section 110 under which each State
shall submit to the Administrator a plan which (A) establishes standards
of performance for any existing source for any air pollutant (i) for
which air quality criteria have not been issued...but (ii) to which a
standard of performance under this section would apply if such existing
source were a new source, and (B) provides for the implementation and
enforcement of such standards of performance.

Section 129(a)(1)(A) states:

The Administrator shall establish performance standards and other
requirements pursuant to section 111 and this section for each category
of solid waste incineration units.  Such standards shall include
emissions limitations and other requirements applicable to new units and
guidelines (under section 111(d) and this section) and other
requirements applicable to existing units.

Section 129(a)(2) states:

Standards applicable to solid waste incineration units promulgated under
section 111 and this section shall reflect the maximum degree of
reduction in emissions of air pollutants listed under section (a)(4)
that the Administrator, taking into consideration the cost of achieving
such emission reduction, and any non-air quality health and
environmental impacts and energy requirements, determines is achievable
for new or existing units in each category.

Section 129(b)(1) states:

Performance standards under this section and section 111 for solid waste
incineration units shall include guidelines promulgated pursuant to
section 111(d) and this section applicable to existing units.  Such
guidelines shall include, as provided in this section, each of the
elements required by subsection (a) (emissions limitations,
notwithstanding any restriction in section 111(d) regarding issuance of
such limitations), subsection (c) (monitoring), subsection (d) (operator
training), subsection (e) (permits), and subsection (h)(4) (residual
risk).

	Subpart B of 40 CFR part 60 requires State Plans to include monitoring,
recordkeeping and reporting provisions consistent with the emission
guidelines.  In addition, section 114(a)(1) states that that the
Administrator may require any owner or operator subject to any
requirement of the CAA 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, dioxin/furan, particulate matter
(PM), carbon monoxide (CO), hydrogen chloride (HCl), sulfur dioxide
(SO2), nitrogen oxides (NOx), lead (Pb), cadmium (Cd), and mercury (Hg)
emissions from HMIWI cause or contribute to air pollution that may
reasonably be anticipated to endanger public health or welfare. 
Therefore, emission guidelines were promulgated for this source category
at 40 CFR part 60, subpart Ce.

	Section 129 of the CAA also requires EPA to review and, if appropriate,
revise the emission guidelines every 5 years.  Section 129(a)(5) states:

Not later than 5 years following the initial promulgation of any
performance standards and other requirements under this section and
section 111 applicable to a category of solid waste incineration units,
and a 5 year intervals thereafter, the Administrator shall review, and
in accordance with this section and section 111, revise such standards
and requirements.

Consequently, revised emission guidelines are currently being processed
for proposal for this source category.

 listnum "WP List 1" \l 2 	Practical Utility/Users of the Data

	Emissions of dioxins/furans, PM, CO, HCl, SO2, NOX, Pb, Cd, and Hg
result from the operation of the facilities affected by the emission
guidelines.  The emission guidelines are achieved by the reduction of
these emissions using good combustion practices and appropriate filter
and scrubber technology.  The control of these emissions from HMIWI
requires not only the installation of properly designed equipment, but
also the operation and maintenance of that equipment.

	The notifications required in the HMIWI regulation are used to inform
the designated agency that an existing source is subject to the
guidelines.  The reviewing authority may then inspect the source to
check if the pollution control devices are properly installed and
operated and the guidelines 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 guidelines, 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.

	Semiannual reports are used for problem identification, as a check on
source operation and maintenance, and for compliance determinations. 
Annual reports are also required, which include: (1) values for
site-specific operating parameters; (2) the highest maximum operating
parameter and the lowest minimum operating parameter; (3) exceedances of
emissions or operating parameters; (4) malfunctions; (5) periods when
data on emissions/operating parameters were not obtained; (6) results of
any performance test conducted during the year; (7) if no exceedances or
malfunctions, a report stating there were no exceedances; (8) any uses
of a bypass stack, the duration, reason for malfunction, and corrective
action taken; and (9) information recorded during the annual control
equipment inspection (included in proposed amendments to the emission
guidelines).  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 emission guidelines
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 emission guidelines.  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. 

 listnum "WP List 1" \l 1 	Nonduplication, Consultations, and Other
Collection Criteria

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

 listnum "WP List 1" \l 2 	Nonduplication

	If a State Plan is disapproved, the State can respond to EPA’s
concerns and submit a revised plan.  If a State does not submit a
revised, approvable State Plan by the second year after adoption of the
emission guidelines, EPA will adopt and implement a Federal Plan that
applies to existing HMIWI in the State.  Consequently, the information
would be submitted to the appropriate EPA Regional office, until such
time as the State is delegated this authority.  Therefore, no
duplication exists.

 listnum "WP List 1" \l 2 	Public Notice Required Prior to ICR
Submission to OMB

	This section is not applicable because this is a rule-related ICR.

 listnum "WP List 1" \l 2 	Consultations

	The HMIWI inventory and emissions data used as the basis for the
revised guidelines were developed with the help of States and
representatives from industry.  A 60-day public comment period will be
provided after proposal, during which the public will be given the
opportunity to comment on the proposed amendments.  Public hearings and
meetings with State and industry stakeholders will also be held, as
necessary, following proposal to discuss EPA’s assessment of new
information submitted with comments, to gather additional information,
and to solicit further comments.  All comments received will be
considered and may be reflected in the development of the final
guidelines.

 listnum "WP List 1" \l 2 	Effects of Less Frequent Collection

	Less frequent information collection would decrease the margin of
assurance that facilities are continuing to meet the guidelines. 
Requirements for information gathering and recordkeeping are a useful
technique to ensure that good operation and maintenance practices are
applied and emission limitations are met.  If the information required
by these guidelines was collected less frequently, the likelihood of
detecting poor operation and maintenance of control equipment and
noncompliance would decrease.  In addition, EPA’s authority to take
administrative action would be significantly reduced.  Section 113(d) of
the CAA limits the assessment of administrative penalties to violations
which occur no more than 12 months before initiation of the
administrative proceeding.  Since administrative proceedings are less
costly and require use of fewer resources than judicial proceedings,
both EPA and the regulated community benefit from preservation of
EPA’s administrative powers.  Also, the reporting frequency in the
guidelines is consistent with the requirements of the title V permit
program.  Consequently, less frequent reports would not result in a
reduced burden.

 listnum "WP List 1" \l 2 	General Guidelines

	None of the reporting or recordkeeping requirements in the emission
guidelines violate any of the regulations established by OMB at 5 CFR
1320.5.  The guidelines require the respondents to maintain all records,
including reports and notifications for at least 5 years.  This is
consistent with the General Provisions as applied to the guidelines. 
EPA believes that the 5-year records retention requirement is consistent
the Part 70 permit program and the 5-year statute of limitations on
which the permit program is based.  The retention of records for 5 years
allows EPA to establish the compliance history of a source, any pattern
of non-compliance and to determine the appropriate level of enforcement
action.  EPA has found that the most flagrant violators have violations
extending beyond 5 years.  In addition, EPA would be prevented from
pursuing the violators due to the destruction or nonexistence of
essential records.

 listnum "WP List 1" \l 2 	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 39999,
September 28, 1978; 43 FR 42251, September 28, 1978; 44 FR 17674,
March 23, 1979).

 listnum "WP List 1" \l 2 	Sensitive Questions

	None of the reporting or recordkeeping requirements in the guidelines
contain sensitive questions.

 listnum "WP List 1" \l 1 	The Respondents and the Information Requested

 listnum "WP List 1" \l 2 	Respondents/NAICS Codes

	The respondents to the recordkeeping and reporting requirements in the
emission guidelines are owners or operators of HMIWI for which
construction commenced before March 20, 1996.  An estimated 72 existing
HMIWI are currently required to comply with the requirements of the
guidelines.  The NAICS codes for the respondents affected by the
guidelines are listed below for source category description.

Guidelines (40 CFR Part 60, Subpart Ce)	NAICS Codes

General Medical and Surgical Hospitals	622110

Specialty Hospitals	622310

Medicinal and Botanical Manufacturing	325411

Pharmaceutical Preparation Manufacturing	325412

Solid Waste Combustors and Incinerators	562213

Colleges, Universities, and Professional Schools	611310

Research and Development in Physical, Chemical, and Life Sciences	541710

National Security	928110

Not all processes classified in these NAICS codes are regulated by the
guidelines.

 listnum "WP List 1" \l 2 	Information Requested

	None of these reporting or recordkeeping requirements violate any of
the regulations established by OMB at 50 CFR 1320.5.

	 listnum "WP List 1" \l 3   Data items.  All data in this ICR that are
recorded and/or reported are required by emission guidelines for HMIWI
(40 CFR part 60, subpart Ce).  Respondents must make the following
reports:

 PRIVATE  Requirement	Guidelines Citation by Section

State Plan to implement and enforce emission guidelines	60.39e(a) and
60.23(a)

Notification of public hearing on State Plan	60.23(d)

Certification that public hearing on State Plan conducted according to
subpart B State procedures	60.23(f)

Notification of initial CMS demonstration	60.7(a)

Notification of initial performance test (PM, stack opacity, fugitive
ash emissions, dioxins/furans, HCl, Cd, Pb, Hg)	60.8(d)

Notification of exemption claim for combustors burning pathological,
low-level radioactive, and/or chemotherapeutic waste	60.32e(b)(1)

Notification of exemption claim for co-fired combustors	60.32e(c)(1)

Notification of relative weight of hospital waste, medical/infectious
waste, and other fuels and/or wastes to be combusted at co-fired
combustor	60.32e(c)(2)

Waste management plan	60.35e, 60.38e(a), 60.55c, 60.58c(c)(3), and
62.14430

Report of initial CMS demonstration	60.7(c)

Report of initial performance test (PM, stack opacity, fugitive ash
emissions, dioxins/furans, HCl, Cd, Pb, Hg)	60.38e(a), 60.58c(d)(6),
60.8(a), and 62.14463(a)

Initial report of values for site-specific operating parameters
60.38e(a), 60.58c(c)(2), and 62.14463(b)

Annual report of values for site-specific operating parameters
60.38e(a), 60.58c(d), and 62.14463(d)-(f)

Annual and semiannual reports of emissions or operating parameter
exceedances, malfunctions, and periods for which data on
emissions/operating parameters were not obtained	60.38e(a), 60.58c(d)
and (e), 60.7(c), 62.14463(g), and 62.14464(b) and (c)

Annual report of no excess emissions	60.38e(a), 60.58c(d)(7), 60.7(c),
and 62.14463(i)

Report of results of annual performance test	60.38e(a), 60.58c(d)(6),
and 62.14463(h)

Results of previous performance tests (included in proposed amendments
to emission guidelines)	60.38e(a) and 60.58c(g)

Annual report containing information from annual equipment inspection,
required maintenance, and repairs not completed during established
timeframe	60.38e(b)(2)

Annual report containing information from annual control equipment
inspection, required maintenance, and repairs not completed during
established timeframe (included in proposed amendments to emission
guidelines)	60.38e(c)(2)

Respondents must keep the following records:

 PRIVATE  Requirement	Guidelines Citation by Section

Records of public hearing conducted on State Plan	60.23(e)

Retention of records for 5 years	60.38e(a), 60.58c(b), and 62.14461

Records of startup, shutdown, or malfunction	60.7(b)

Records of operators completing review of HMIWI operating manual
60.38e(a), 60.58c(b)(8), and 62.14460(g)

Records of operators completing operator training course and
qualification requirements	60.38e(a), 60.58c(b)(9) and (10), and
62.14460(h) and (i)

Records of initial testing of fugitive ash emissions (included in
proposed amendments to emission guidelines)	60.38e(a) and
60.58c(b)(2)(ii)

Records of process and control device operating parameters	60.38e(a) and
60.58c(b)(2)(iii)-(xv), and 62.14460(b)(2)-(12), (14) and (15)

Records of CMS operation and maintenance	60.7(f)

Records of emissions or operating parameter exceedances, malfunctions,
and periods for which data on emissions/operating parameters were not
obtained	60.38e(a), 60.58c(b)(3)-(5), and 62.14460(c)-(e)

Records of initial, annual, and any subsequent performance tests
60.38e(a), 60.58c(b)(6), and 62.14460(f)

Records of calibration of monitoring devices	60.38e(a), 60.58c(b)(11),
and 62.14460(j)

Records of annual equipment inspections, required maintenance, and
repairs not completed during established timeframe	60.38e(b)(1) and
62.14460(b)(13)

Records of annual control equipment inspections, required maintenance,
and repairs not completed during established timeframe (included in
proposed amendments to emission guidelines)	60.58c(c)(1)

Records on quarterly basis of types and amounts of materials charged for
co-fired combustors and for incinerators burning only pathological,
low-level radioactive, and/or chemotherapeutical waste	60.32(e)(b) and
(c) and 62.14400(b)

  

	 listnum "WP List 1" \l 3   Respondent activities.  The respondent
activities required by the guidelines in the first 3 years following the
effective date are provided below:

Respondent Activities

Read instructions.

Develop State Plan and inventory and update inventory annually

Conduct public hearing on State Plan

Perform CMS demonstrations and repeat CMS demonstrations if necessary

Perform performance tests and repeat performance tests if necessary

Develop, update, and review operating information

Perform inspections

Prepare and submit the notifications and reports listed in the table
above

Develop waste management plan

Prepare and review reports of performance tests

Prepare and review reports of CMS demonstrations

Complete operator training and qualification

Maintain the records listed in the table above

Train personnel

	Currently, sources are using monitoring equipment that provides
automated parameter data, e.g., scrubber pressure drop.  Although
personnel at the affected facility 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 15 percent of
the respondents use electronic reporting.

 listnum "WP List 1" \l 1 	The Information Collected--Agency Activities,
Collection Methodology, and Information Management

 listnum "WP List 1" \l 2 	Agency Activities

	The 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

Respond to litigation of the guidelines

Observe enforcement activities (retesting) related to excess emissions

Review notifications and reports (listed in the table above), including
performance test reports, excess emissions reports, study addressing
siting requirements, waste management, required to be submitted by
industry

Audit facility records

Input, analyze, and maintain data in the Air Facility System (AFS)

 listnum "WP List 1" \l 2 	Collection Methodology and Management

	Following initial notification, the reviewing authority may 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
guidelines.  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.  The AFS is
EPA’s database for the collection, maintenance, and retrieval of
compliance data for approximately 125,000 industrial and
government-owned facilities.  The EPA uses the AFS for tracking air
pollution compliance and enforcement by local and State regulatory
agencies, EPA Regional offices and EPA headquarters. The 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 

5 years.

 listnum "WP List 1" \l 2 	Small Entity Flexibility

	None of the HMIWI expected to be impacted under the revised guidelines
are owned by small entities, and only a few HMIWI overall are owned by
small entities, based on the definition used by the Small Business
Administration (500, 750, or fewer employees; and $11.5 million, $31.5
million, or less in annual sales—depending on the company NAICS
codes).  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 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.  However, the
regulation includes various provisions that would reduce the burden on
HMIWI, including small entities.  For example, there are less
restrictive guidelines and reporting requirements for small rural HMIWI,
for co-fired combustors, and for incinerators burning only pathological,
low-level radioactive, and/or chemotherapeutic waste.  There are also
provisions allowing HMIWI to skip annual tests and reports for 2-year
periods if they have demonstrated compliance for three annual tests in a
row.  Also, the current proposal would allow HMIWI to submit previous
emission tests to demonstrate compliance with the emission limits in the
revised guidelines.

 listnum "WP List 1" \l 2 	Collection Schedule

	The specific frequency for each information collection activity within
this request is shown in Table 1.

 listnum "WP List 1" \l 1 	Estimating the Burden and Cost of the
Collection

	This section presents estimates of the burden and cost associated with
the reporting and recordkeeping requirements in the emission guidelines.
 Table 1 presents the average annual burden and cost estimates for
respondents, while Table 2 presents the average annual burden and cost
estimates for the Federal government.

 listnum "WP List 1" \l 2 	Estimating Respondent Burden

	Table 1 documents the computation of individual burdens for the
recordkeeping and reporting requirements applicable to the 72 existing
HMIWI subject to the emission guidelines.  The individual burdens are
expressed under standardized headings designed 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.

	The annual average burden to industry over the next 3 years from these
recordkeeping and reporting requirements is estimated to be 49,878
hours.  These hours are based on Agency studies and background documents
from the development of the regulation, Agency knowledge and experience
with the part 60 and 62 regulations, the previously approved ICR, and
any comments received.

 listnum "WP List 1" \l 2 	Estimating Respondent Costs

	 listnum "WP List 1" \l 3   Estimating labor costs.  Table 1 presents
the costs of the recordkeeping and reporting requirements applicable to
the 72 existing HMIWI subject to the emission guidelines.  The average
annual labor cost for industry during the 3 years of the ICR is
estimated to be $2,433,045.  The ICR uses the following labor rates to
estimate the industry and State government labor costs:

			Industry			State Government

	Technical	$45.29	($27.12 x 167%)	$54.38	($33.99 x 160%)

	Management	$73.10	($43.77 x 167%)	$72.32	($45.20 x 160%)

	Clerical	$32.90	($19.70 x 167%)	$40.74	($25.46 x 160%)

These labor rates are from the U.S. Department of Labor, Bureau of Labor
Statistics, June 2006, “Table 9. Private industry workers, by
occupational group” and “Table 4.  State and local government
workers, by occupational and industry group.”  The rates from both
tables are from column 1, “Total compensation.”  The industry labor
rates were adjusted by an overhead and profit rate of 167 percent, while
the State government labor rates were multiplied by the standard
government benefits factor of 1.6.

	 listnum "WP List 1" \l 3   Estimating capital/startup and operation
and maintenance costs.  The types of industry costs associated with the
information collection activities in the guidelines are labor costs
associated with recordkeeping and reporting, which are addressed
elsewhere in this ICR, and costs associated with continuous monitoring. 
The capital/startup costs are the one-time costs incurred when a
facility becomes subject to the regulation, and typically include
equipment purchased for the purpose of satisfying EPA requirements
(e.g., monitoring equipment, in-house testing equipment, file cabinets).
 A one-time capital/startup cost can be estimated over multiple years by
annualizing the cost using an OMB-approved interest rate.  The annual
operation and maintenance (O&M) costs are the ongoing costs incurred to
maintain the capital equipment (e.g., labor, maintenance materials, and
overhead) and the costs associated with the paperwork requirements
incurred continuously over the life of the ICR (e.g., photocopying and
postage). Tables 3 through 7 present the annualized capital/startup and
O&M costs associated with the emission guidelines.

	The 72 existing HMIWI have already installed monitoring equipment to
comply with the original emission guidelines, and no additional
monitoring equipment are needed for the revised guidelines. 
Consequently, annualized capital costs and annual O&M costs for these
equipment are already being incurred.  Under the revised guidelines, all
existing HMIWI will need to purchase equipment for in-house testing of
fugitive ash emissions.

	The capital/startup costs associated with file cabinets for storing
collected data and reports include the purchase of one standard
four-drawer file cabinet for each facility (assume $235 per file
cabinet).  Photocopying costs per response are estimated at 0.5 hour of
clerical labor at a rate of $32.90/hr.  Postage costs are estimated at
$4.05 per response for mailing to regulatory agencies, based on the
Priority Mail shipping rate for the U.S. Postal Service.

	The total annualized capital/startup cost over the first 3 years after
the effective date is $407,953, while the total annual O&M cost is
$333,258.  Combining the annualized capital costs with the annual O&M
cost gives a total annualized cost of $741,211 for the 3 years after the
effective date.

 listnum "WP List 1" \l 2 	Estimating Agency Burden and Cost

	Because the information collection requirements were developed as an
incidental part of standards development, no costs can be attributed to
the development of the information collection requirements.  Because
reporting and recordkeeping requirements on the part of the respondents
are required under Section 111 of the CAA, no operational costs will be
incurred by the Federal government.  Publication and distribution of the
information are part of the AFS, with the result that no Federal costs
can be directly attributed to the ICR.  Examination of records to be
maintained by the respondents will occur incidentally as part of the
periodic inspection of sources that is part of EPA’s overall
compliance and enforcement program and, therefore, is not attributable
to the ICR.

	The only costs to the Federal government are those costs associated
with the analysis of the reported information, onsite observation of the
initial CMS demonstrations and initial performance tests and retests,
review and approval of State Plans and inventories, enforcement
activities due to excess emissions, and litigation activities.

	Table 2 presents the average annual burden and cost estimates for the
Federal government.  The average annual Agency burden and cost during
the 3 years of the ICR are estimated to be 1,277 hours and $608,392
(including travel expenses).  The cost is based on the following average
hourly labor rates:

	Technical	$42.45	(GS-12, Step 1, $26.53 x 160%)

	Management	$57.20	(GS-13, Step 5, $35.75 x 160%)

	Clerical	$22.96	(GS-6, Step 3, $14.35 x 160%)

	These labor rates are from the Office of Personnel Management (OPM)
“2006 General Schedule,” which excludes locality rates of pay.  The
rates were multiplied by the standard government benefits factor of 1.6.

 listnum "WP List 1" \l 2 	Estimating the Respondent Universe and Total
Burden and Costs

	Based on our research for this ICR, 72 existing HMIWI, and the 23
States in which they reside, will be subject to the requirements of the
revised guidelines.  (Only 13 of the 23 States currently have approved
State Plans under the original guidelines, but all 23 States are assumed
to have State Plans approved by the third year after promulgation of the
revised guidelines.)  The emission guidelines regulate only existing
sources; therefore, no new respondents will become subject to the
guidelines over the next 3 years.  The total number of 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 respondents that keep records but do not submit reports	(E)

Total annual responses

E = (B x C) + D

Read instructions (States)	7.7	1	N/A	7.7

Develop State Plan/inventory	7.7	1	N/A	7.7

Annual update of State Plan inventory	16	1	N/A	16

Public hearing on State Plan	7.7	1	N/A	7.7

Notification of public hearing on State Plan	7.7	1	N/A	7.7

Certification that public hearing conducted according to subpart B State
procedures	7.7	1	N/A	7.7

Read instructions (HMIWI)	24	1	N/A	24

Initial CMS demonstration	6.3	1	N/A	6.3

Annual update of operating information	72	1	N/A	72

Review of operating information with each operator	72	2	N/A	144

Annual equipment inspection (small rural HMIWI)	6	1	N/A	6

Initial control equipment inspection (all other HMIWI)	22	1	N/A	22

Notification of initial performance test (CDD/CDF, metals, fugitive ash
emissions)	4	1	N/A	4

Notification of initial performance test (fugitive ash emissions)	20	1
N/A	20

Notification of initial CMS demonstration	6	1	N/A	6

Report of initial performance test (CDD/CDF, metals, fugitive ash
emissions)	4	1	N/A	4

Report of initial performance test (fugitive ash emissions)	20	1	N/A	20

Annual report

CMS emissions and operating parameters	72	1	N/A	72

Exceedances, malfunctions, and periods for which data not obtained	14	1
N/A	14

Results of performance tests conducted during the year	72	1	N/A	72

Report of no exceedances	58	1	N/A	58

Semiannual report of exceedances, malfunctions, and periods for which
data not obtaineda	14	1	N/A	14

 	 	 	Total	614

a Because the semiannual report coincides once each year with the annual
report and both reports include information on exceedances,
malfunctions, and periods for which data were not obtained, the
frequency of the semiannual report is shown in the table as only once
per year to avoid double-counting.

	The number of total annual responses is 614.

 listnum "WP List 1" \l 2 	Bottom Line Burden Hours and Costs/Master
Tables

	 listnum "WP List 1" \l 3   Respondent tally.  The bottom line
respondent burden hours and costs, presented in Table 1, are calculated
by adding person-hours per year down each column for technical,
management, and clerical staff, and by adding down the cost column.  The
total hours requested are 49,878 hours (19,587 hours for States; 30,291
hours for HMIWI).  The total annual labor cost is $2,433,045 ($1,057,197
for States; $1,375,848 for HMIWI).  The total annual capital/startup and
O&M costs to the regulated entities are $741,211 ($802 for States;
$740,409 for HMIWI).

	 listnum "WP List 1" \l 3   The Agency tally.  The bottom line Agency
burden hours and costs, presented in Table 2, are calculated as in the
respondent table, by adding person-hours per year down each column for
technical, managerial, and clerical staff, and by adding down the cost
column.  In this case, travel expenses for performance tests and CMS
demonstrations attended are also added to this salary cost.  The annual
average burden for all Agency activities is 1,277 hours, and the total
annual cost is $608,392 (including travel expenses). 

	 listnum "WP List 1" \l 3   Variations in the annual bottom line.  Each
year, all existing HMIWI, and the States with approved State Plans where
those HMIWI reside, incur the same recurring burden and costs associated
with the emission guidelines (update of State Plan inventory, submittal
of annual and semiannual reports).  In the first year after
promulgation, all 23 States in which the 72 existing HMIWI reside will
also be required to prepare and submit new State Plans and inventories
to EPA under the revised emission guidelines and prepare for and hold
public hearings, if requested, on the new State Plans.  In the third
year after promulgation, all 72 existing HMIWI also incur the additional
burden and cost associated with preparing and submitting notifications
and reports of the initial fugitive ash emission tests required for all
existing HMIWI under the revised emission guidelines.  Also, all but the
6 small rural HMIWI incur the additional burden and cost associated with
conducting control equipment inspections under the revised emission
guidelines.  (The 6 small rural HMIWI are already required under the
original emission guidelines to conduct equipment inspections, including
control equipment.)

	Similarly, each year, the Federal government incurs the same recurring
burden and costs associated with the emission guidelines (reviewing
annual and semiannual reports, conducting enforcement activities related
to excess emissions), but also incurs the same burden and costs
associated with litigation related to the revised emission guidelines. 
In the first year, the Federal government also incurs the additional
burden and cost of reviewing public hearing notifications and
certifications on the new State Plans.  In the second year after
promulgation, the Federal government also incurs the additional burden
and cost of reviewing the new State Plans and inventories submitted to
EPA and developing a new Federal Plan, if necessary.  In the third year
after promulgation, the Federal government also incurs the additional
burden of attending initial performance tests and reviewing
notifications and reports of initial performance tests and CMS
demonstrations.

 listnum "WP List 1" \l 2 	Reasons for Change in Burden

	The reduction in burden from the most recently approved ICR is
primarily due to a decrease in applicable burden items and hours.  The
ongoing recordkeeping requirements for co-fired combustors and
incinerators burning only pathological, low-level radioactive, and/or
chemotherapeutic waste have been omitted.  The burden estimate
associated with records of CMS O&M has also been reduced based on
average O&M estimates for existing sources.  These reductions in burden
offset the increase in burden associated with the new requirements in
the revised emission guidelines (e.g., new State Plans and inventories,
initial stack tests and CMS demonstrations for all HMIWI impacted under
the revised guidelines, initial fugitive ash emission tests for all
HMIWI, and initial and annual control equipment inspections for all but
small rural HMIWI).  The industry labor rates associated with the burden
estimates have also been revised and updated.

 listnum "WP List 1" \l 2 	Burden Statement

	The annual burden for this collection of information is estimated to
average 358 hours per response for States and 54 hours per response for
HMIWI.  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-OAR-2006-0534, which is available for online viewing at  
HYPERLINK "http://www.regulations.gov"  www.regulations.gov , or in
person viewing at the Air and Radiation Docket and Information Center in
the EPA Docket Center (EPA/DC), EPA West, Room 3334, 1301 Constitution
Avenue, NW, 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 Air and Radiation Docket and
Information Center is (202) 566-1742.  An electronic version of the
public docket is available at www.regulations.gov.  This site can be
used 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, NW,
Washington, D.C. 20503, Attention: Desk Officer for EPA.  Please include
the EPA Docket ID Number EPA-HQ-OAR-2006-0534 and OMB Control Number
2060-0422 in any correspondence.	PART B OF THE SUPPORTING STATEMENT

	Hospital/Medical/Infectious Waste Incinerators

	This section is not applicable because statistical methods are not
used in data collection associated with this regulation.



 

 

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