2335ss01

PART A OF THE SUPPORTING STATEMENT

Hospital/Medical/Infectious Waste Incinerators

 Identification of the Information Collection

 Title and Number of the Information Collection

“EG for Hospital/Medical/Infectious Waste Incinerators (40 CFR part 60, subpart Ce) (Proposed Rule).” This is a revision of an approved existing Information Collection Request (ICR) currently approved under OMB Control Number 2060-0422 (EPA ICR number 1899.04). The revisions have been assigned EPA tracking number 2335.01.

 Short Characterization

Emission guidelines for hospital/medical/infectious waste incinerators (HMIWI), 40 CFR part 60, subpart Ce, were promulgated on September 15, 1997. The guidelines applied to owners or operators of HMIWI for which construction commenced on or before June 20, 1996 and State regulatory agencies. Revised emission guidelines are being proposed which would apply to those sources and also to owners or operators of the five HMIWI currently subject to the new source performance standards (NSPS) for HMIWI (40 CFR part 60, subpart Ec) as promulgated in 1997, for which construction commenced after June 20, 1996 but on or before the date of the current proposal. The reporting and recordkeeping requirements for HMIWI regulated by subpart Ec are covered in under OMB Control Number 2060-0363.

Subpart Ce requires States to develop plans to implement the emission guidelines. If approvable State Plans were not developed, the U.S. Environmental Protection Agency (EPA) was required to develop a Federal plan to implement the emission guidelines in those States. A Federal plan to implement the 1997 emission guidelines was promulgated on September 14, 2000 (40 CFR part 62, subpart HHH), and a new Federal plan will be promulgated at a later date to implement the revised emission guidelines. 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 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 57 existing HMIWI located at 51 different facilities. An estimated 45 of these HMIWI are owned and operated by the private sector (hospitals, waste disposal companies, pharmaceutical companies, and private universities); 6 are owned and operated by the Federal government (U.S. military base, veterans hospitals, and Federal research facilities); and 6 are owned and operated by State or local governments (State universities and local waste treatment facility). The emission guidelines regulate only existing sources; therefore, no new respondents will become subject to the guidelines over the next 3 years.

 Need for and Use of the Collection

 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 (NO_x), 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 on September 15, 1997.

On November 14, 1997, the Sierra Club and the Natural Resources Defense Council (Sierra Club) filed suit in the U.S. Court of Appeals for the District of Columbia Circuit (the Court) challenging EPA’s methodology for adopting the regulations. On March 2, 1999, the Court issued its opinion. The Court remanded the rule to EPA for further explanation of the Agency’s reasoning in determining the minimum regulatory ”floors” for new and existing HMIWI. The Court did not vacate the regulations, so the NSPS and emission guidelines remained in effect during the remand and were fully implemented by September 2002.

On February 6, 2007, EPA published a notice that proposed the Agency’s response to the questions raised in the Court’s remand and that also proposed its response to the CAA section 129(a)(5) requirement to review the NSPS and emission guidelines every 5 years, which is cited below:

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.

Following recent court decisions and receipt of public comments regarding that proposal, EPA chose to reassess its responses to the questions raised in the Court’s remand. The results of EPA’s reassessment are being provided in the form of another proposed response to the questions raised in the Court’s remand. As before, the re-proposal also satisfies the requirement under section 129(a)(5) to conduct a review of the standards every 5 years.

 Practical Utility/Users of the Data

Emissions of dioxins/furans, PM, CO, HCl, SO₂, NO_X, 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 waste minimization, 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 Agency or delegated authority 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.

 Nonduplication, Consultations, and Other Collection Criteria

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

 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.

 Public Notice Required Prior to ICR Submission to OMB

The preamble of the proposed rule will provide notice to the public of the submission of this ICR to OMB.

 Consultations

Participants in the development process for the proposed amendments to the emission guidelines included representatives from industry, States, and other stakeholders. Meetings and discussions were held with these representatives to develop the HMIWI inventory and emissions data used as the basis for the revised guidelines. 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.

 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.

 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 with 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.

 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).

 Sensitive Questions

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

 The Respondents and the Information Requested

 Respondents/NAICS Codes

The respondents to the recordkeeping and reporting requirements in the revised emission guidelines are owners or operators of HMIWI for which construction commenced on or before the date of the current proposal. An estimated 57 existing HMIWI (45 privately-owned, 6 Federally-owned, and 6 State/locally-owned) would be required to comply with the requirements of the revised 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
Public Health Facility	923120

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

 Information Requested

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

 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:

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	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	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)	60.37e(f) and 60.38e(a)
Annual report containing information from annual equipment inspection, required maintenance, and repairs not completed during established timeframe for small rural HMIWI	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(b)(2)

Respondents must keep the following records:

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)-(xvii), 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 for small rural HMIWI	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)	60.38e(b)(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	60.32e(b) and (c) and 62.14400(b)

 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 facilities 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.

 The Information Collected--Agency Activities, Collection Methodology, and Information Management

 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 previous table), including performance test reports, excess emissions reports, and waste management, required to be submitted by industry.

Audit facility records.

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

 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.

 Small Entity Flexibility

Only two of the HMIWI regulated under the revised guidelines are owned by a small entity, based on a population cutoff of 50,000 people for small governmental jurisdictions. 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 provisions allowing HMIWI to skip annual tests and test 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.

 Collection Schedule

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

 Estimating Respondent Burden

Table 1 documents the computation of individual burdens for the recordkeeping and reporting requirements applicable to the 57 existing HMIWI (45 privately-owned, 6 Federally-owned, and 6 State/locally owned) that are subject to the revised 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 over the next 3 years from these recordkeeping and reporting requirements is estimated to be 44,275 hours (41,557 private and state/local; 2,718 federal). 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.

 Estimating Respondent Costs

 Estimating labor costs. Table 1 presents the costs of the recordkeeping and reporting requirements applicable to the 57 existing HMIWI subject to the revised emission guidelines. The average annual labor cost during the 3 years of the ICR is estimated to be $1,873,286 ($1,770,257 private and state/local; $103,029 federal). The ICR uses the following labor rates to estimate the industry and State government labor costs:

Industry State Government

Technical $37.55 ($23.47 x 160%) $50.00 ($31.25 x 160%)

Management $78.76 ($49.23 x 160%) $65.98 ($41.24 x 160%)

Clerical $21.10 ($13.19 x 160%) $22.59 ($14.12 x 160%)

The industry labor rates are from the U.S. Department of Labor, Bureau of Labor Statistics, May 2007 National Industry-Specific Occupational Employment and Wage Estimates for State government (NAICS code 999200) and for the most common sectors of the HMIWI industry (NAICS codes 622100, 325400, 562200, and 611300). (Weighted average labor rates for technical, management, and clerical staff in the HMIWI industry were developed from labor rates in the four industry sectors.) The industry labor rates were adjusted by an overhead and profit rate of 160 percent, while the State government labor rates were multiplied by the standard government benefits factor of 1.6.

 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 57 existing HMIWI have already installed monitoring equipment to comply with the 1997 emission guidelines, but some additional monitoring equipment are needed for the revised guidelines. Consequently, some of the annualized capital costs and annual O&M costs presented here for monitoring 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 $22.59/hr for States and $21.10/hr for industry. Postage costs are estimated at $4.80 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 $1,457,506, while the total annual O&M cost is $687,398. Combining the annualized capital costs with the annual O&M cost gives a total annualized cost of $2,144,904 ($2,045,054 private and state/local and $99,850 federal) for the 3 years after the effective date.

 Estimating Agency Burden and Cost

Environmental Protection Agency

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 13,734 hours and $594,633 (including travel expenses). The cost is based on the following average hourly labor rates:

Technical $44.24 (GS-12, Step 1, $27.65 x 160%)

Management $59.63 (GS-13, Step 5, $37.27 x 160%)

Clerical $23.94 (GS-6, Step 3, $14.96 x 160%)

These labor rates are from the Office of Personnel Management (OPM) “2008 General Schedule,” which excludes locality rates of pay. The rates were multiplied by the standard government benefits factor of 1.6.

Federal Facilities

The total annual costs for federal facilities is $202,878 ($103,029 in labor costs and $99,850 in capital and O&M costs). See sections 6(a) and 6(b).

 Estimating the Respondent Universe and Total Burden and Costs

Based on our research for this ICR, 57 existing HMIWI (45 privately-owned, 6 Federally-owned, and 6 State/locally-owned HMIWI), and the 22 States in which they reside, will be subject to the requirements of the revised guidelines. (Only 12 of the 22 States currently have approved State Plans under the 1997 guidelines, but all 22 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
Information Collection Activity	States	Privately-Owned HMIWI	Federally-Owned HMIWI	State/ Locally-Owned HMIWI	Total
State Plan/inventory	7.3				7.3
Annual update of State Plan inventory	15.3				15.3
Notification of public hearing on State Plan	7.3				7.3
Certification that public hearing conducted according to subpart B State procedures	7.3				7.3
Notification of initial performance test (pollutants, fugitive ash emissions)		14.7	2.0	1.3	18.0
Notification of initial performance test (fugitive ash emissions)		0.3		0.7	1.0
Notification of initial CMS demonstration		15.0	2.0	2.0	19.0
Report of initial performance test (pollutants, fugitive ash emissions)		14.7	2.0	1.3	18.0
Report of initial performance test (fugitive ash emissions)		0.3		0.7	1.0
Report of initial CMS demonstration		15.0	2.0	2.0	19.0
Annual report
CMS emissions and operating parameters		45.0	6.0	6.0	57.0
Exceedances, malfunctions, and periods for which data not obtained		9.0	1.2	1.2	11.4
Results of performance tests conducted during the year		45.0	6.0	6.0	57.0
Report of no exceedances		36.0	4.8	4.8	45.6
Report of annual equipment inspection (small rural HMIWI)		2.0			2.0
Semiannual report of exceedances, malfunctions, and periods for which data not obtaineda		9.0	1.2	1.2	11.4
Total	37.3	206	27.2	27.2	297.7

^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 approximately 298 (approximately 37 for States, 206 for privately-owned HMIWI, and 27 each for Federally- and State/locally-owned HMIWI).

 Bottom Line Burden Hours and Costs/Master Tables

 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 44,275 hours, which include 18,729 hours for States; 20,116 hours for privately-owned HMIWI; 2,718 hours for Federally-owned HMIWI; and 2,712 hours for State/locally-owned HMIWI. The total annual labor cost is $1,873,286, which includes $904,818 for States; $762,614 for privately-owned HMIWI; $103,029 for Federally-owned HMIWI; and $102,825 for State/locally-owned HMIWI. The total annual capital/startup and O&M costs to the regulated entities are $2,144,904, which include $601 for States; $1,898,105 for privately-owned HMIWI; $99,850 for Federally-owned HMIWI; and $146,348 for State/locally-owned HMIWI.

 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 13,734 hours, and the total annual cost is $594,633 (including travel expenses). The annual average burden for federal facilities is $202,878.

 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 original emission guidelines (update of State Plan inventory, submittal of annual and semiannual reports). In the first year after promulgation, all 22 States in which the 57 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 57 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 2 small rural HMIWI incur the additional burden and cost associated with conducting control equipment inspections under the revised emission guidelines. (The 2 small rural HMIWI are already required under the 1997 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 original 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.

 Reasons for Change in Burden

The reduction in labor burden from the existing requirements is primarily due to a reduction in the number of respondents, 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. However, the resulting reduction in labor costs is more than offset by the increase in annual capital/startup and O&M costs, which is a result of the increased monitoring and testing activity that would be necessary under the current proposed revisions to the emission guidelines.

 Burden Statement

The annual burden for this collection of information is estimated to average 502 hours per response for States, 98 hours per response for privately-owned HMIWI, and 100 hours per response each for Federally- and State/locally-owned 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 www.regulations.gov, or in person viewing at the Air and Radiation Docket 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 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-NEW 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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