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SUPPORTING STATEMENT

ENVIRONMENTAL PROTECTION AGENCY

State and Federal Emission Guidelines for Hospital/Medical/Infectious Waste Incineration (40 CFR Part 60, Subpart Ce and 40 CFR Part 62, Subpart HHH) (Renewal)

1. Identification of the Information Collection

1(a) Title of the Information Collection

State and Federal Emission Guidelines for Hospital/Medical/Infectious Waste Incineration (40 CFR Part 60, Subpart Ce and 40 CFR Part 62, Subpart HHH) (Renewal)

1(b) Short Characterization/Abstract

This supporting statement addresses information collection activities imposed by the Emission Guidelines for Hospital/Medical/Infectious Waste Incinerators (Emission Guidelines), 40 CFR part 60, subpart Ce and 40 CFR part 62, subpart HHH. Subpart Ce, promulgated on September 15, 1997, requires states or tribes to develop plans to implement the Emission Guidelines. If approvable state or tribal plans were not developed, EPA was required to develop a Federal plan to implement the Emission Guidelines in such states or tribes. The Federal plan, subpart HHH, was promulgated on September 14, 2000. For the purpose of this Information Collection Request (ICR), subparts Ce and HHH will be referred to as "the Emission Guidelines." States and tribes may choose to impose requirements that are more stringent. However, the burden estimates provided in this ICR assume that the state and tribal 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 notification reports and records are essential in determining compliance.

The reporting and recordkeeping requirements differ for Hospital/Medical/Infectious Waste Incinerators (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 each of these three facility types. This information is being collected to assure compliance with 40 CFR part 60, subpart Ce and 40 CFR part 63, subpart HHH.

Any owner or operator subject to the provisions of this part shall maintain a file of these measurements, and retain the file for at least five years following the date of such measurements, maintenance reports, and records. All reports are sent to the delegated state or local authority. In the event that there is no such delegated authority, the reports are sent directly to the U.S. Environmental Protection Agency (EPA) regional office.

Based on our consultations with industry representatives, we have determined that there are 51 respondents with 57 existing HMIWI facilities. We have determined that the number of respondents for the Private Sector (Business for Profit) is 35. Furthermore, the number of State; Local; or Tribal government entities is 12, and the remaining four respondents are Federal Government entities. It is estimated that no additional facilities per year will become subject to the regulation.

All of the HMIWI in the United States are either owned or operated by the Private Sector, Federal Government or State; Local; or Tribal government. The burden to the “Affected Public” is listed in Table 1: Annual Industry Burden and Cost – State and Federal Emission Guidelines for Hospital/Medical/Infectious Waste Incineration (40 CFR Part 60, Subpart Ce and 40 CFR Part 62, Subpart HHH). The Federal government burden associated with the review of reports submitted by the respondent is shown in Table 2: Average Annual EPA Burden – State and Federal Emission Guidelines for Hospital/Medical/Infectious Waste Incineration (40 CFR Part 60, Subpart Ce and 40 CFR Part 62, Subpart HHH).

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

2. Need for and Use of the Collection

2(a) Need/Authority for the Collection

The EPA is charged under section 111(d)(1) of the Clean Air Act (CAA), as amended, to:

. . . 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 or which is not included on a list published under section 108(a) . . . 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.

The EPA is required under section 129 of the Act, to establish guidelines for existing stationary sources that reflect the maximum achievable control technology (MACT) for achieving continuous emission reductions:

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:

The Administrator may require any person who owns or operates any emission source, who manufactures emission control equipment or process equipment, who the Administrator believes may have information necessary for the purposes set forth in this subsection, or who is subject to any requirement of this Act (other than a manufacturer subject to the provisions of section 206(c) or 208 with respect to a provision of title II) on a one-time, periodic or continuous basis 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 Administer 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, particulate matter (PM), carbon monoxide (CO), dioxins/furans (D/F), hydrogen chloride (HCl), sulfur dioxide (SO₂), nitrogen oxides (NO_x), lead (Pb), cadmium (Cd), and mercury (Hg) emissions from hospital, medical, or infectious waste incinerators contribute to air pollution that may reasonably be anticipated to endanger public health or welfare. Therefore, the state and Federal emission guidelines were promulgated for this source category at 40 CFR part 60, subpart Ce and 40 CFR part 62, subpart HHH.

2(b) Practical Utility/Users of the Data

The recordkeeping and reporting requirements in the standard ensure compliance with the applicable regulations which were promulgated in accordance with the Clean Air Act. In addition, the collected information is used for targeting inspections and as evidence in legal proceedings.

Performance tests are required in order to determine an affected facility’s initial capability to comply with the emission standard. Continuous emission monitors are used to ensure compliance with the standard at all times. During the performance tests, a record of the operating parameters under which compliance was achieved may be recorded and used to determine compliance in place of a continuous emission monitor.

The notifications required in the standard are used to inform the Agency or delegated authority when a source becomes subject to the requirements of the regulations. The reviewing authority may then inspect the source to ensure that the pollution control devices are properly installed and operated, that leaks are being detected and repaired, and that the standards are being met. The performance test may also be observed.

3. Nonduplication, Consultations, and Other Collection Criteria

The requested recordkeeping and reporting are required under 40 CFR part 60, subpart Ce, and 40 CFR part 62, subpart HHH.

3(a) Nonduplication

If the subject standards have not been delegated, the information is sent directly to the appropriate EPA regional office. Otherwise, the information is sent directly to the delegated state or local agency. If a state or local agency has adopted their own similar standards to implement the Federal standards, a copy of the report submitted to the state or local agency can be sent to the Administrator in lieu of the report required by the Federal standards. Therefore, no duplication exists.

3(b) Public Notice Required Prior to ICR Submission to OMB

An announcement of a public comment period for the renewal of this ICR was published in the Federal Register (73 FR 31088) on May 30, 2008. No comments were received on the burden published in the Federal Register.

3(c) Consultations

The Agency’s industry experts have been consulted, and the Agency’s internal data sources and projections of industry growth over the next three years have been considered. The primary source of information as reported by industry, in compliance with the recordkeeping and reporting provisions in the standard, is the Online Tracking Information System (OTIS) which is operated and maintained by the EPA Office of Compliance. OTIS is the EPA database for the collection, maintenance, and retrieval of all compliance data. The growth rate for the industry is based on our consultations with the Agency’s internal industry experts. The HMIWI inventory of facilities can be located at http://www.epa.gov/airtoxics/129/hmiwi/rihmiwi.html#IMP. Approximately 51 respondents will be subject to the standard over the three-year period covered by this ICR.

Industry trade associations and other interested parties were provided an opportunity to comment on the burden associated with the standard as it was being developed.

It is our policy to respond after a thorough review of comments received since the last ICR renewal as well as those submitted in response to the first Federal Register notice.

3(d) Effects of Less Frequent Collection

Less frequent information collection would decrease the margin of assurance that facilities are continuing to meet the standards. Requirements for information gathering and recordkeeping are useful techniques to ensure that good operation and maintenance practices are applied and emission limitations are met. If the information required by these standards was collected less frequently, the proper operation and maintenance of control equipment and the possibility of detecting violations would be less likely.

3(e) General Guidelines

None of these reporting or recordkeeping requirements violate any of the regulations established by OMB at 5 CFR part 1320, section 1320.5.

These standards require the respondents to maintain all records, including reports and notifications for at least five years. This is consistent with the General Provisions as applied to the standards. EPA believes that the five-year records retention requirement is consistent with the Part 70 permit program and the five-year statute of limitations on which the permit program is based on. The retention of records for five 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 the five years. In addition, EPA would be prevented from pursuing the violators due to the destruction or nonexistence of essential records.

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 North American Industry Classification System (NAICS) code, are listed below for source category description.

Standard (40 CFR, part 60, subpart Ce and 40 CFR part 61, subpart HHH)	NAICS Codes
Hospitals	622110
Refuse Systems	562213
Commercial Physical and Biological Research	541740
Nursing and Personal Care Facilities	623110
Nursing and Personal Care Facilities	623111
Veterinary Services	542940

4(b) Information Requested

None of these reporting or recordkeeping requirements violate any of the regulations established by OMB at 5 CFR part 1320, section 1320.5.

(i) Data Items

In this ICR, all of the data recorded or reported are required by the State and Federal Emission Guidelines for Hospital/Medical/Infectious Waste Incinerators (40 CFR Part 60, Subpart Ce, and 40 CFR Part 62, subpart HHH).

A source must make the following reports:

Notifications
Installation of CMS	60.37(e), 60.56(c), 60.57(c) 62.14454
Initial and repeat performance specification tests for CMS	60.37(e), 60.56(c), 60.57(c), 62.14454(f)
Initial equipment inspection (small rural HMIWI)	60.37(b), 60.56(c), 60.57(c), 62.14440
Increments of progress for HMIWI that will comply with regulation	60.39e(c)
Request for extension to shut down late	60.39e(d)
Waste management plan	60.353(a), 60.55c(c), 60.58c(c), 62.14430
Notification of HMIWI capacity	60.58c(a)
Notification of initial CMS demonstration	60.38e(a), 60.7
Report of initial CMS demonstration	60.38e(a), 60.7(c)
Notification of exemption claim for combustors burning pathological, low-level radioactive, and/or chemotherapeutic waste	60.32e(b)
Annual report containing information from annual equipment inspection, required maintenance, and repairs not completed during established time frame	60.38e(b)
Notification of exemption claim for co-fired combustors	60,32e(c)
Notification of relative weight of hospital waste, medical/infectious waste, and other fuels and/or waste to be combusted at co-fired combustor	60.32e(c)
Notification of initial performance test (PM, CO, fugitive emissions, stack opacity, dioxins/furans, HCI, Cd, Pb, Hg)	60.38e(a), 60.8(d)
Report on initial performance test data (PM, CO, fugitive emissions, stack opacity, dioxins/furans, HCI, Cd, Pb, Hg)	60.38e(a), 60.58c(c), 60.8(a), 62.14463(a)
Values for site-specific operating parameters	60.38e(a), 60.58c(c), 62.14463(f)
Annual report of values for site-specific operating parameters	60.38e(a), 60.58c(d), 62.14463(f)
Annual report of the highest maximum and lowest minimum operating parameters (covering the last two years)	60.38e(a), 60.58c(d), 62.14463(d)
Annual report of emissions or operating parameter exceedances, malfunctions, and periods for which data on emissions/operating parameters were not obtained (covering the last two years)	60.38e(a), 60.58c(d), 60.7(c), 62.14463(g)
Annual report containing results of annual performance test	60.38e(b), 60.58c(d), 62.14464(b)
If no excess emissions, malfunctions, or operating parameter exceedances, annual report stating so	60.38e(a), 60.58c(d), 62.14463(i)
Any use of the bypass stack, duration, reason for malfunction, and corrective action taken	60.38e(a), 60.58c(d), 62.14463(j)
Semiannual report of emissions or operating parameter exceedances, malfunction, and periods for which data on emissions/operating parameters were not obtained	60.38e(a), 60.58c(e), 60.7(c-d) 62.14464(c)
Annual update of operating information	60.34(e), 60.53c(i), 62.14423(c)
Annual review of operating information with each operator	60.34(e), 60.53c(h), 6214425(a)

A source must keep the following records:

Recordkeeping
Retention of records for 5 years, related to emissions	60.38e(a), 60.58c(b), 60.58c(f), 62.14461
Records of startup, shutdown, or malfunction	60.38e(a), 60.57c, 60.7(b), 62.14460(d)
Records of initial performance test	60.37e, 60.57c, 62.14460(a)
Records of CMS operation and maintenance	60.38e(a), 60.57c, 60.7(f), 62.14460(a)
Records of annual equipment inspections, required maintenance, and repairs not completed during established timeframe	60.38e(b), 62.14460(a)
Records on a quarterly basis of periods, when only pathological, low-level radioactive, and/or chemotherapeutical waste is burned.	60.32e(b), 62.14400
Records of quarterly basis of weight of hospital waste and medical/infectious waste combusted, and weight of all other fuels and waste combusted at co-fired combustors	60.32e(c), 62.14400
Records for which data on emissions/operating parameters were not obtained	60.38e(a), 60.58c(b), 60.8(f), 62.14460(c)
Records related to malfunctions	60.38e(a), 60.58c(b), 60.8(f), 62.14460(d)
Records of emissions or operating parameter exceedances	60.38e(a), 60.58c(b), 60.8(f), 62.14460(e)
Records of initial, annual, and any subsequent performance tests	60.38e(a), 60.58c(b), 60.8(f), 62.14460(f)
Records of persons completing reviews of HMIWI operating manual (initial and annual)	60.38e(a), 60.58c(b), 62.14460(g)
Records of operators completing operator training course and qualification requirements	60.38e(a), 60.58c(b), 62.14460(h)
Records of operators who have met the qualification requirements	60.38e(a), 60.58c(b), 62.14460(i)
Records of calibration of any monitoring devices	60.38e(a), 60.58c(b), 62.14460(j)
Records of emissions, process, and control device operating parameters	60.38e(a), 60.58c(b), 60.8(f), 62.14460(a)

Electronic Reporting

Some of the respondents are using monitoring equipment that automatically records parameter data. Although personnel at the affected facility must still evaluate the data, internal automation has significantly reduced the burden associated with monitoring and recordkeeping at a plant site.

Also, regulatory agencies in cooperation with the respondents continue to create reporting systems to transmit data electronically. However, electronic reporting systems are not widely used. At this time, it is estimated that 10 per cent of the respondents use electronic reporting.

(ii) Respondent Activities

Respondent Activities

Read instructions.

Install, calibrate, maintain, and operate continuous monitoring systems or continuous emission monitoring systems for continuously measuring and recording the emissions of pollutants from an affected facility.

Perform initial performance test and repeat performance tests if necessary. Use applicable reference test method.

Write the notifications and reports listed above.

Develop site-specific operating parameters.

Develop waste management plan.

Enter information required to be recorded above.

Submit the required reports developing, acquiring, installing, and utilizing technology and systems for the purpose of collecting, validating, and verifying information.

Develop, acquire, install, and utilize technology and systems for the purpose of processing and maintaining information.

Develop, acquire, install, and utilize technology and systems for the purpose of disclosing and providing information.

Adjust the existing ways to comply with any previously applicable instructions and requirements.

Train personnel to be able to respond to a collection of information.

Transmit, or otherwise disclose the information.

Currently, sources are using monitoring equipment that provides parameter data in an automated way (e.g., continuous parameter monitoring system). Although personnel at the source still need to evaluate the data, this type of monitoring equipment has significantly reduced the burden associated with monitoring and recordkeeping.

5. The Information Collected: Agency Activities, Collection Methodology, and Information Management

5(a) Agency Activities

EPA conducts the following activities in connection with the acquisition, analysis, storage, and distribution of the required information.

Agency Activities

Observe initial performance tests and repeat performance tests if necessary.

Review notifications and reports, including performance test reports, excess emissions reports, required to be submitted by industry.

Audit facility records.

Input, analyze, and maintain data in the OTIS.

5(b) Collection Methodology and Management

Following notification of startup, the reviewing authority might inspect the source to determine whether the pollution control devices are properly installed and operational. Performance test reports are used by the Agency to discern a source’s initial capability to comply with the emission standard, and note the operating conditions under which compliance was achieved. Data and records maintained by the respondents are tabulated and published for use in compliance and enforcement programs.

Information contained in the reports is entered into OTIS which is operated and maintained by the EPA Office of Compliance. OTIS is the EPA database for the collection, maintenance, and retrieval of compliance data for approximately 125,000 industrial and government-owned facilities. EPA uses OTIS for tracking air pollution compliance and enforcement by local and state regulatory agencies, EPA regional offices, and EPA headquarters. EPA 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

The majority of the respondents are large entities (i.e., large businesses). However, the impact on small entities (i.e., small businesses) was taken into consideration during the development of the regulation. Due to technical considerations involving the process operations and the types of control equipment employed, the recordkeeping and reporting requirements are the same for both small and large entities. The Agency considers these to be the minimum requirements needed to ensure compliance and, therefore, cannot reduce them further for small entities. To the extent that larger businesses can use economies of scale to reduce their burden, the overall burden will be reduced.

5(d) Collection Schedule

The specific frequency for each information collection activity within this request is shown in Table 1: Annual Industry Burden for State and Federal Emission Guidelines for Hospital/ Medical/Infectious Waste Incinerators 40 CFR Part 60, Subpart Ce and 40 CFR Part 62, Subpart HHH) (Renewal).

6. Estimating the Burden and Cost of the Collection

Table 1 documents the computation of individual burdens for the recordkeeping and reporting requirements applicable to the industry for the subpart included in this ICR. The individual burdens are expressed under standardized headings believed to be consistent with the concept of burden under the Paperwork Reduction Act. Wherever appropriate, specific tasks and major assumptions have been identified. Responses to this information collection are mandatory.

The Agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB Control Number.

6(a) Estimating Respondent Burden

The average annual burden to industry over the next three years from these recordkeeping and reporting requirements is estimated to be 46,987 (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 part 60 and 62 regulations, 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 $113.19 ($53.90 + 110%)

Technical $96.73 ($46.06 + 110%)

Clerical $45.93 ($21.87 + 110%)

These rates are from the United States Department of Labor, Bureau of Labor Statistics, September 2008, Table 2. Civilian Workers, by occupational and industry group. The rates are from column 1, Total compensation. The rates have been increased by 110 percent to account for the benefit packages available to those employed by private industry.

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

The type of industry costs associated with the information collection activities in the subject standard are both labor costs, which are addressed elsewhere in this ICR, and the costs associated with continuous monitoring. The capital/startup costs are one-time costs when a facility becomes subject to the regulation. The annual operation and maintenance costs are the ongoing costs to maintain the monitor and other costs, such as photocopying and postage.

(iii) Capital/Startup vs. Operation and Maintenance (O&M) Costs

Capital/Startup vs. Operation and Maintenance (O&M) Costs
(A) Continuous Monitoring Device	(B) Capital/ Startup Cost for One Respondent	(C) Number of 1 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 2	(G) Total O&M, (E X F)
Temperature pressure, flow rate, charge rate, voltage and pH monitors
a. Private Sector	N/A	0	$0	$1,800	35	$63,000
b. State; Local; Tribal Government	N/A	0	$0	$1,800	12	$21,600
			$0			$84,600

1. The average HMIWI operates approximately 6 continuous monitoring devices. The average cost per monitoring device is $300 per year. Therefore, the estimated O&M cost per respondent is estimated to be $1,800

2. See Table 1(b) for “Affected Public” break-down on the number of facilities in each category

Capital/Startup vs. Operation and Maintenance (O&M) Costs
(A) Continuous Monitoring Device	(B) Capital/ Startup Cost for One Respondent	(C) Number of 1 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 2	(G) Total O&M, (E X F)
Temperature pressure, flow rate, charge rate, voltage and pH monitors
a. Federal Government	N/A	0	$0	$1,800	4	$7,200
			$0			$7,200

The total capital/startup costs for this ICR are zero. This is the total of column D in the above table.

The total operation and maintenance (O&M) costs consists of photocopying, and postage are $63,000 for (Private Sector), $21,600 for State; Local; Tribal Government. The Federal Government cost is $7,200. This is the total of column G.

The average annual cost for capital/startup and operation and maintenance costs over the next three years of the ICR is estimated to be $63,000 for Private Sector, $21,600 (rounded) for State; Local; Tribal Government for a total of $84,600. The Federal Government cost of $7,200, is accounted for in Table 2 under [6. Capital/Startup vs. Operation and Maintenance (O&M)] Costs.

6(c) Estimating Agency Burden and Cost

The only costs to the Agency are those costs associated with analysis of the reported information. The EPA compliance and enforcement program includes activities such as, the examination of records maintained by the respondents, periodic inspection of sources of emissions and the publication and distribution of collected information.

The average annual Agency cost during the three years of the ICR is estimated to be $284,385.

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

Managerial $61.36 (GS-13, Step 5, $38.35 + 60%)

Technical $45.52 (GS-12, Step 1, $28.45 + 60%)

Clerical $24.64 (GS-6, Step 3, $15.40 + 60%)

These rates are from the Office of Personnel Management (OPM) A2009 General Schedule@, which excludes locality rates of pay. The rates have been increased by 60 percent to account for the benefit packages available to government employees. Details upon which this estimate is based appear in Table 2: Average Annual EPA Burden, State and Federal Emission Guidelines for Hospital/Medical/Infectious Waste Incinerators (40 CFR Part 60, Subpart Ce and 40 CFR Part 62, Subpart HHH). (Below.)

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

Based on our research for this ICR, approximately 51 respondents will be subject to the standard the next three years. Out of the 51 respondents, four of these facilities are owned by the Federal Government and operated by government employees. It is estimated that no additional sources per year will become subject to the standard. The average number of respondents, as shown in the table below, is 51 per year.

The number of respondents is calculated using the following table that addresses the three years covered by this ICR.

Number of Respondents
Year	(A) Number of 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	0	51	0	0	51
2	0	51	0	0	51
3	0	51	0	0	51
Average	0	51	0	0	51

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

² See Table 1(b) for “Affected Public” break-down on the number of facilities in each category.

To avoid double-counting respondents, column D is subtracted. As shown above, the average Number of Respondents covered by the three tables, over the three-year period of this ICR is 51.

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 1
Annual reports	47	1	0	47
Semiannual reports of emissions/parameter exceedances	47	2	0	94
			Total	141

1. See Table 1(b) for “Affected Public” break-down on the number of responses in each category

The number of Total Annual Responses is 141.

The total annual labor costs are $5,004,102. Details regarding these estimates can be found in Table 1: Annual Industry Burden and Cost – State and Federal Emission Guidelines for Hospital/ Medical/Infectious Waste Incinerators (40 CFR Part 60, Subpart Ce and 40 CFR Part 62, Subpart HHH) (Renewal).

6(e) Bottom Line Burden Hours Burden Hours and Cost Tables

The detailed bottom line burden hours and cost calculations for the respondents and the Agency are shown in Tables 1 and 2, respectively, and summarized below.

(i) Respondent Tally

The total annual labor hours are 46,987. Details regarding these estimates may be found in Table 1. Annual Respondent Burden and Cost: State and Federal Emission Guidelines for Hospital/ Medical/ Infectious Waste Incinerators (40 CFR Part 60, Subpart Ce and 40 CFR Part 62, Subpart HHH) (Renewal) Furthermore, the annual public reporting and recordkeeping burden for this collection of information is estimated to average 333 hours (rounded) per response.

The total annual capital/startup and O&M costs to the regulated entity are; 1) Private Sector for $63,000, 2) State, Local, Tribal for $21,600. The Federal Government cost of $7,200 is accounted for in Table 2.

.

(ii) The Agency Tally

The average annual Agency burden and cost over next three years is estimated to be 6,243 labor hours at a cost of $284,385. See Table 2. Annual Agency Burden and Cost: State and Federal Emission Guidelines for Hospital/ Medical/Infectious Waste Incinerators (40 CFR Part 60, Subpart Ce and 40 CFR Part 62, Subpart HHH) (Renewal).

6(f) Reasons for Change in Burden

There is a change in the labor hours in this ICR compared to the previous ICR. This is due to a decrease in the number of sources. We have also added an additional Table 1(b). This table shows the break down of two of the “Affected Public” that this ICR covers.

The third “Affected Public” is the Federal Government. The four Federal Government facilities are operated entirely by Federal Employees; therefore, all of the Federal Government burdens are accounted for in Table 2.

There is a decrease in the capital/startup and operations and maintenance (O&M) costs from the previous ICR. This is also due to a decrease in the number of sources.

6(g) Burden Statement

The annual public reporting and recordkeeping burden for this collection of information is estimated to average 333 hours per response. Burden means the total time, effort, or financial resources expended by persons to generate, maintain, retain, disclose or provide information to or for a Federal agency. This includes the time needed to review instructions; develop, acquire, install, and utilize technology and systems for the purposes of collecting, validating, and verifying information, processing and maintaining information, and disclosing and providing information; adjust the existing ways to comply with any previously applicable instructions and requirements; train personnel to be able to respond to a collection of information; search data sources; complete and review the collection of information; and transmit or otherwise disclose the information.

An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a valid OMB Control Number. The OMB Control Numbers for EPA=s regulations are listed at 40 CFR part 9 and 48 CFR chapter 15.

To comment on the Agency's need for this information, the accuracy of the provided burden estimates, and any suggested methods for minimizing respondent burden, including the use of automated collection techniques, EPA has established a public docket for this ICR under Docket ID Number EPA-HQ-OECA-2008-0283. An electronic version of the public docket is available at http://www.regulations.gov/ which may be used to obtain a copy of the draft collection of information, submit or view public comments, access the index listing of the content of the docket, and to access those documents in the public docket that are available electronically. When in the system, select “search” than key in the docket ID number identified in this document. The documents are also available for public viewing at the Enforcement and Compliance Docket and Information Center in the EPA Docket Center (EPA/DC), EPA West, Room 3334, 1301 Constitution Avenue, N.W., Washington, DC. The EPA Docket Center Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Reading Room is (202) 566-1744, and the telephone number for the Enforcement and Compliance Docket and Information Center Docket is (202) 566-1927. Also, you can send comments to the Office of Information and Regulatory Affairs, Office of Management and Budget, 725 17th Street, N.W., Washington, DC 20503, Attention: Desk Officer for EPA. Please include the EPA Docket ID Number EPA-HQ-OECA-2008-0283 and OMB Control Number 2060-0422 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(a): Annual Respondent Burden and Cost – State and Federal Emission Guidelines for Hospital/Medical/Infectious Waste Incinerators (40 CFR Part 60, Subpart Ce and 40 CFR Part 62, Subpart HHH)

Burden item	(A) Person hours per occurrence	(B) No. of occurrences per respondent per year	(C) 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
A. Read instructions c, d	40	1	40	0	0	0	0	$0
B. Required activities
Installation of CMS d	15	1	15	0	0	0	0	$0
Performance specification tests for CMS d	8	1	8	0	0	0	0	$0
Repeat performance specification tests/CMS d	8	1	8	0	0	0	0	$0
Initial equipment inspection (small rural HMIWI) d	8	1	8	0	0	0	0	$0
Annual update of operating information e	20	1	20	47	940	47	94	$115,263.33
Review operating information with each Operator f	8	2	16	47	752	37.6	75.2	$92,209.87
Annual equipment inspection (small rural HMIWI)	8	1	8	2	16	0.8	1.6	$1,711.72
C. Create information	See 3B
Development of operating information d, g	160	1	160	0	0	0	0	$0
D. Gather information	See 3B
E. Write report
Increments of progress for HMIWI that will Comply
Control plan	24	1	24	0	0	0	0	$0
Notification of construction contracts d	2	1	2	0	0	0	0	$0
Notification of construction commencement d	2	1	2	0	0	0	0	$0
Notification of construction completion d	2	1	2	0	0	0	0	$0
Notification of control plan completion d	2	1	0	0	0	0	0	$0
Request for extension to shut down date d, h	12	1	12	0	0	0	0	$0
Notification of initial performance test d	2	1	2	0	0	0	0	$0
Notification of initial CMS demonstration d	2	1	2	0	0	0	0	$0
Waste management plan d, i	160	1	160	0	0	0	0	$0
Report of initial performance test for PM, CO, Hg, dioxins/furans, and stack opacity (small rural HMIWI) d, j	560	1	560	0	0	0	0	$0
Report of initial performance test for PM, CO, HCI, dioxins/furans, metals, and stack opacity (small non-rural, medium, and large HMIWI) d, k	640	1	640	0	0	0	0	$0
Report of initial CMS demonstration	See 3B
Annual report (small non-rural, medium, and large HMIWI)
CMS operating parameters l	15	1	15	47	705	35.25	70.5	$86,446.74
Emissions/parameter exceedances and periods when emission/parameter data not Obtained m	64	1	64	9	576	28.8	57.6	$70,628.83
Report of annual performance test n	280	1	280	38	10,640	532	1,064	$1,304,671.48
Report of no exceedances	32	1	32	38	1,216	60.8	121.6	$149,105.31
Annual report (small rural HMIWI)
CMS operating parameters	15	1	15	2	30	1.5	3	$4,209.47
Emissions/parameter exceedances and periods when emission/parameter data not Obtained o	16	1	16	0.4	6.4	0.32	0.64	$684.68
Report of annual performance test	20	1	20	2	40	2	4	$4,279.30
Report of no exceedances	8	1	8	1.6	12.8	0.64	1.28	$1,369.37
Report of annual equipment inspection	See 3B
Semiannual report of emissions/parameter exceedances and periods when emission/ parameter data not obtained (small non-rural, medium, and large HMIWI)	32	2	64	9	576	28.8	57.6	$70,628.83
Semiannual report of emissions/parameter exceedances and periods when emission/ parameter data not obtained (small rural HMIWI) p	8	2	16	0.4	6.4	0.32	0.64	$684.68
4. Reporting requirements (co-fired combustors and pathological/low-level radioactive/ chemotherapeutic waste combustors)
A. Read instructions	N/A
B. Required activities	N/A
C. Create information	N/A
D. Gather existing information	N/A
E. Write report
Notification of exemption claim d	2	1	2	0	0	0	0	$0
Notification of relative amounts of hospital waste, medical/infectious waste, and other fuels and wastes to be combusted (co-fired combustors only) d	2	1	2	0	0	0	0	$0
Subtotal for Reporting Requirements						17,844.09
5. Recordkeeping requirements (HMIWI)
A. Read instructions	N/A
B. Plan activities	N/A
C. Implement activities	N/A
D. Develop record system	N/A
E. Time to enter information
Records of startup, shutdown, malfunction q	1.5	52	78	47	3,666	183.3	366.6	$449,523.09
Records of persons reviewing operating information r	2	2	4	47	188	9.4	18.8	$23,052.46
Records of operators completing training d Requirements	2	1	2	0	0	0	0	$0
Records of operators that have been qualified	2	1	2	0	0	0	0	$0
Records of initial performance test	See 3E
Records of process and control device operating parameters (small non-rural, medium, and large HMIWI)	1.5	52	78	45	3,510	175.5	351	$430,394.44
Records of CMS operation and maintenance (small non-rural, medium, and large HMIWI)	1.5	250	375	45	16,875	843.75	1,687.5	$2,069,204.06
Records of emissions/parameter exceedances and periods when emission/parameter data not obtained (small non-rural, medium, and large HMIWI)	1.5	52	78	9	702	35.1	70.2	$86,078.89
Records of process and control device operating parameters (small rural HMIWI)	0.5	52	26	2	52	2.6	5.2	$5,563.09
Records of CMS operation and maintenance s	0.5	250	125	2	250	12.5	25	$26,745.62
Records of emissions/parameter exceedances and periods when emission/parameter data not obtained (small rural HMIWI) t	0.5	52	26	0.4	10.4	0.52	1.04	$1,112.62
Records of annual and subsequent compliance tests	See 3E
Records of annual equipment inspection	See 3B
F. Time to train personnel d, u	40	1	40	0	0	0	0	$0
G. Time for audits	N/A
Subtotal for Reporting Requirements
6. Recordkeeping requirements (co-fired and pathological/low-level radioactive/ chemotherapeutic combustors)
A. Read instructions	N/A
B. Plan activities	N/A
C. Implement activities	N/A
D. Develop record system	N/A
E. Time to enter information
Quarterly records of periods when only pathological, low-level radioactive, chemotherapeutic waste burned v	2	4	8	9	72	3.6	7.2	$8,828.61
Quarterly records of weight of hospital waste and medical/infectious waste combusted, and weight of all other fuels and waste combusted (co-fired only)	2	4	8	2	16	0.8	1.6	$1,711.72
G. Time for audits	N/A
Subtotal for Recordkeeping Requirements						29,142.61
					25,341.4	1,267.07	2,534.14	$5,004,102.21
TOTAL LABOR BURDEN AND COST (rounded)						46,986.7 46,987 (rounded)		$5,004,102

Assumptions:

^a We have assumed that there are approximately 47 respondents, with no additional new or reconstructed sources becoming subject to the rule over the next three years.

The breakdown is as follows: 35 Public Sector, and 12 State, Local, or Tribal Government.

^b This ICR uses the following labor rates: $113,19 per hour for Executive, Administrative, and Managerial labor; $96.73 per hour for Technical labor, and $45.93 per hour for Clerical labor. These rates are from the United States Department of Labor, Bureau of Labor Statistics, September 2008, Table 2. Civilian Workers, by occupational and industry group. The rates are from column 1, Total compensation. The rates have been increased by 110 percent to account for the benefit packages available to those employed by private industry.

^c We have assumed that it will take 40 hours for each new respondent to read requirements.

^d The zero value for number of respondents indicates that burden was incurred prior to the time period covered by this supporting statement or for new respondents.

^e We have assumed that it would take each respondent 20 hours each to update the annual operating information.

^f We have assumed that it would take each of the 2 small rural HMIWI respondents 8 hours complete the annual equipment inspection.

^g We have assumed that each facility will take 160 hours to develop the operating information.

^h We have assumed that 5 percent of HMIWI that shut down will request and extension to shut down after the first compliance date (3 years after promulgation of the Emission Guideline.

ⁱ We have assumed that each facility will rake 40 hours to develop the waste management plan.

^j We have assumed that each respondent will take 560 hours to write the report on the initial performance test for small rural HMIWI.

^k We have assumed that each respondent will take 640 hours to write the report on the initial performance test for small non-rural, medium, and large HMIWI.

^l We have assumed that it will take 15 hours to incorporate CMS operating parameters for small non-rural, medium, and large HMIWI operating hours into the annual report.

^m We have assumed that 20 percent of respondents (small non-rural, medium, and large HMIWI) will take 64 hours to write the emissions/parameter exceedances and periods report.

ⁿ We have assumed that 80 percent of respondents (small non-rural, medium, and large HMIWI) will take 280 hours to write the annual performance test report.

^o We have assumed that 20 percent of small rural HMIWI respondents will each take16 hours once a year to complete the emissions/parameter exceedances and periods when emissions/parameter data not obtained report

^p We have assumed that 20 percent of small rural HMIWI respondents will each take eight hours two times per year to complete the semiannual report of emissions/parameter exceedances and periods when emission/parameter data not obtained.

^q We have assumed that each respondents will take 1.5 hours fifty-two times per year to record startup, shutdown, or malfunction activity.

^r We have assumed that each respondent will take 2 hours two times per year to record information of persons reviewing operating activity.

^s We have assumed that respondents of small rural HMIWI will each take 30 minutes 250 times per year to maintain records of CMS operation and maintenance.

^t We have assumed that 20 percent of respondents of small rural HMIWI will each take 30 minutes per week to record emissions/parameter exceedances and periods when emission/parameter data not obtained.

^u We have assumed that labor requirements to train personnel at each facility were estimated to be 8 hours per day for 5 days per year.

^v We have assumed that each of the nine respondents will take 2 hours to enter information on quarterly records of periods when only pathological, low-level radioactive, chemotherapeutic waste burned.

Table 1(b) “Affected Public” Broken Down According to Number of Facilities in Each Category

Respondents	Number of Respondents	Responses	Capital/Startup & O&M Cost	Labor Costs
Private Sector (Business for-profits)	35	105	$63,000	$3,726,459.09
State, Local, or Tribal Government	12	36	$21,600	$1,277,643.12
Total	47	141	$84,600	$5,004,102.21

Reporting and Recordkeeping Hours for Each Category

Respondents	Total Reporting Hours 17,844.09	Recordkeeping Hours 29,142.61	Labor Hours 46,987
Private Sector (Business for-profits)	13,288.15	21,701.94	34,990.09
State, Local, or Tribal Government	4,555.94	7,440.67	11,996.61
Total	17,844.09	29,142.61	46,987 (rounded)

Table 2: Average Annual EPA Burden - State and Federal Emission Guidelines for Hospital/Medical/Infectious Waste Incinerators (40 CFR Part 60, Subpart Ce and 40 CFR Part 62, Subpart HHH)

Activity	(A) EPA person- hours per occurrence	(B) No. of occurrences per plant per year	(C) EPA person- hours per plant per year (C=AxB)	(D) Plants 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) Cost, $ b
1. Initial performance test	32	1	32	0	0	0	0	$0
2. Repeat performance test
A. Retesting preparation	12	1	12	0	0	0	0	$0
B. Attend retesting	32	1	32	0	0	0	0	$0
3. Report review
A. Review reports for co-fired combustors						0
Review notification of exemption claim	2	1	2	0	0	0	0	$0
Review notification of relative amounts of hospital waste, medical/infectious waste, and other fuels and wastes to be Combusted	2	1	2	0	0	0	0	$0
B. Review notification of exemption claim for pathological, low-level radioactive, chemotherapeutic combustors	2	1	2	0	0	0	0	$0
C. Review reports of increments of progress
Review control plan	4	1	4	0	0	0	0	$0
Review notification of construction Contracts	2	1	2	0	0	0	0	$0
Review notification of construction Commencement	2	1	2	0	0	0	0	$0
Review notification of construction Completion	2	1	2	0	0	0	0	$0
Review notification of control plan completion	2	1	2	0	0	0	0	$0
D. Review request for extension for HMIWI planning to shut down late	4	1	4	0	0	0	0	$0
E. Review reports for small non-rural, medium and large HMIWI
Review waste management plan	8	1	8	0	0	0	0	$0
Review notification of initial performance test	8	1	8	0	0	0	0	$0
Review notification of initial CMS demonstration	5	1	5	0	0	0	0	$0
Review report of initial performance test	36	1	36	0	0	0	0	$0
Review report of initial CMS demonstration	24	1	24	0	0	0	0	$0
Review annual report
CMS operating parameters	6	1	6	47	282	14.1	28.2	$14,396.67
Emissions/parameter exceedances and periods when emission/parameter data not obtained c	16	1	16	9	144	7.2	14.4	$7,351.49
Results of annual performance test	24	1	24	47	1,128	56.4	112.8	$57,586.65
Report of no exceedances d	8	1	8	38	304	15.2	30.4	$15,519.81
Review semiannual report of emissions/ parameter exceedances and periods when emission/parameter data not obtained e	8	1	8	9	72	3.6	7.2	$3,675.75
F. Review reports for small rural HMIWI
Review waste management plan	8	1	8	0	0	0	0	$0
Review notification of initial performance test	8	1	8	0	0	0	0	$0
Review notification of initial CMS demonstration	5	1	5	0	0	0	0	$0
Review report of initial performance test	30	1	30	0	0	0	0	$0
Review report of initial CMS demonstration	8	1	8	0	0	0	0	$0
Review annual report
CMS operating parameters f	2	1	2	2	4	0.2	0.4	$204.21
Emissions/parameter exceedances and periods when emission/parameter data not Obtained g	4	1	4	0.4	1.6	0.08	0.16	$125.86
Results of annual performance test h	6	1	6	2	12	0.6	1.2	$612.63
Report of no exceedances i	2	1	2	1.6	3.2	0.16	0.32	$163.35
Report of annual equipment inspection	4	1	4	2	8	0.4	0.8	$408.41
Review semiannual report of emissions/ parameter	2	1	2	0.4	0.8	0.04	0.08	$40.84
4. Prepare annual summary report j	1	1	1	47	47	2.35	4.7	$2,399.45
5. Federal Government Owned Facilities k
Annual update of operating information	20	1	20	4	80	4	8	$4,084.16
Review operating information with each operator	8	2	16	4	64	3.2	6.4	$3,267.33
CMS operating parameters	15	1	15	4	60	3	6	$3,063.12
Emissions/parameter exceedances and periods when emission/parameter data not obtained	64	1	64	1	64	3.2	6.4	$3,267.33
Report of annual performance test	280	1	280	3	840	42	84	$42,883.68
report of no exceedances	32	1	32	3	96	4.8	9.6	$4,900.99
Records of startup, shutdown, malfunction	1.5	52	78	4	312	15.6	31.2	$15,928.23
Records of persons reviewing operating information	2	2	4	4	16	0.8	1.6	$816.83
Records of process and control device operating parameters (small non-rural, medium, and large HMIWI)	1.5	52	78	4	312	15.6	31.2	$15,928.23
Records of CMS operating and maintenance (small non-rural, medium and large HMIWI)	1.5	250	375	4	1,500	75	150	$76,578.00
Records of emissions/parameter exceedances and periods when emission/parameter data not obtained (small non-rural, medium, and large HMIWI)	1.5	52	78	1	78	3.9	7.8	$3,982.05
6. Capital/Startup vs. Operation and Maintenance (O&M) costs k				4				$7,200.00
Subtotals Labor Burden and cost					5,428.6	271.43	542.86	$284,385.07
TOTAL ANNUAL BURDEN AND COST (rounded)					6,242.89 6,243 (rounded)			$284,385

Assumptions:

^a We have assumed that there are approximately 51 respondents, with no additional new or reconstructed sources becoming subject to the rule over the next three years.

The breakdown is as follows: 35 are owned by Private Sector, 12 are owned by State, Local, or Tribal Government, and four are owned by the Federal Government.

^b This cost is based on the following hourly labor rates times a 1.6 benefits multiplication factor to account for government overhead expenses: $61.36 for Managerial (GS-13, Step 5, $38.35 x 1.6), $45.52 for Technical (GS-12, Step 1, $28.45 x 1.6) and $24.64 Clerical (GS-6, Step 3, $15.40 x 1.6). These rates are from the Office of Personnel Management (OPM) A2009 General Schedule@ which excludes locality rates of pay.

^c We have assumed that 20 percent of respondents will review annual report on parameter exceedances.

^d We have assumed that 80 percent of respondents will take eight hours each to review annual report of no exceedances.

^e We have assumed that 20 percent of respondents will take eight hours each to review semiannual report of parameter exceedances and periods when emission/parameter data not obtained.

^f We have assumed that all of the two small rural HMIWI respondents will each take 2 hours to review annual reports for CMS operating parameters.

^g We have assumed that 20 percent of small rural HMIWI respondents will review the annual report on emissions/parameter exceedances and periods.

^h We have assumed that all of the two small rural HMIWI respondents will each take 6 hours to review the annual report on the results of annual performance test.

ⁱ We have assumed that 80 percent of respondents will each take 2 hours to review annual report of no exceedances.

^j We have assumed that all respondents will have to prepare annual summary report.

^k We have assumed that all of the four Federal Government facilities are operated by federal employees; therefore, all of the federal burdens are accounted for in this table.