1730ss[1].06

14

SUPPORTING STATEMENT

ENVIRONMENTAL PROTECTION AGENCY

NSPS for Hospital/Medical/Infectious Waste Incinerators

1. Identification of the Information Collection

1(a) Title of the Information Collection

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

1(b) Short Characterization/Abstract

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

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

In general, all NSPS standards require initial notifications, performance tests, and periodic reports. Owners or operators are also required to maintain records of the occurrence and duration of any startup, shutdown, or malfunction in the operation of an affected facility, or any period during which the monitoring system is inoperative. These notifications, reports, and records are essential in determining compliance, and are required of all sources subject to the standard. The owners or operators must also submit annual and semiannual reports.

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

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

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

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

2. Need for and Use of the Collection

2(a) Need/Authority for the Collection

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

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

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

In addition, section 114(a) states that the Administrator may require any owner or operator subject to any requirement of this Act to:

(A) Establish and maintain such records; (B) make such reports; (C) install, use, and maintain such monitoring equipment, and use such audit procedures, or methods; (D) sample such emissions (in accordance with such procedures or methods, at such locations, at such intervals, during such periods, and in such manner as the Administrator shall prescribe); (E) keep records on control equipment parameters, production variables or other indirect data when direct monitoring of emissions is impractical; (F) submit compliance certifications in accordance with Section 114(a)(3); and (G) provide such other information as the Administrator may reasonably require.

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

2(b) Practical Utility/Users of the Data

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

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

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

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

3. Nonduplication, Consultations, and Other Collection Criteria

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

3(a) Nonduplication

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

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

An announcement of a public comment period for the renewal of this ICR was published in the Federal Register (72 FR 10735) on March 9, 2007. No comments were received on the burden published in the Federal Register.

3(c) Consultations

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

3(d) Effects of Less Frequent Collection

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

3(e) General Guidelines

These reporting or recordkeeping requirements do not violate any of the regulations promulgated by OMB under 5 CFR part 1320, section 1320.5.

3(f) Confidentiality

Any information submitted to the Agency for which a claim of confidentiality is made will be safeguarded according to the Agency policies set forth in title 40, chapter 1, part 2, subpart B - Confidentiality of Business Information (CBI) (see 40 CFR 2; 41 FR 36902, September 1, 1976; amended by 43 FR 40000, September 8, 1978; 43 FR 42251, September 20, 1978; 44 FR 17674, March 23, 1979).

3(g) Sensitive Questions

None of the reporting or recordkeeping requirements contain sensitive questions.

4. The Respondents and the Information Requested

4(a) Respondents/SIC Codes

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

40 CFR part 60, subpart Ec	SIC Codes	NAICS Codes
General Medical and Surgical Hospitals	8062	622110
	8069	622110
Psychiatric and Substance Abuse Hospitals	8063	622210
	8069	622210
Continuing Care Retirement Communities	8051	623311
	8052	623311
	8059	623311
Nursing Care Facilities	8051	623110
	8052	623110
	8059	623110
Residential Mental Retardation Facilities	8051	623210
	8052	623210
	8059	623210
Specialty (except Psychiatric and Substance Abuse) hospitable	8069	622310
Research and Development in the Physical , Engineering, and Life Sciences	8731	541710
Hazardous Waste Treatment and Disposal	4953	562211
Materials Recovery Facilities	4953	562920
Other Non-hazardous Waste Treatment and Disposal	4953	562219
Solid Waste Combustors and Incinerators	4953	562213
Solid Waste Landfill	4953	562212
Veterinary Services	0741	541940
	0742	541940

4(b) Information Requested

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

(i) Data Items

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

A source must make the following reports:

Notifications Reports
Statement if intent to construct/modify	60.58c(a)(1)(i)
Notification and application of construction or modification	60.58c(a), 60.7(a)
Notification of actual startup	60.7(a)
Notification of type(s) of waste to be combusted	60.58c(a)(2)(i)
Notification of HMIWI capacity	60.58c(a)(2)(ii)
Documents produced as a result of the siting requirements	60.58c(a)(1)(iii), 60.54c(c)
Waste reduction plan	60.58c(a)(2)(i)
Notification of initial performance tests (PM, stack opacity, fugitive ash emissions, CDD/CDF, HCI, CD, Pb, Hg)	60.58c(c)(1), 60.8(d)
Notification of site-specific operating parameters or changes	60.58c(c)(2), 60.7(a)
Notification of initial performance tests (PM, stack opacity, fugitive ash emissions, CDD/CDF, HCI, Cd, Pb, Hg)	60.58c(c)(1), 60.8(a)
Report of site-specific operating parameters	60.58c(d)(1)
Report of annual and semiannual emissions or operating parameter exceedances, malfunctions, and periods for which data on emissions/ operating parameters were not obtained	60.58c(d), 60.58(e), 60.7(c)
Report of no excess emissions	60.59(d)(7), 60.7(c)
Petition for site-specific operating permits (if applicable)	60.58c(a)(iii)
Report of exceedances	60.58c(b)(5)
Report of performance test	60.58c(d)(6)

A source must keep the following records:

Recordkeeping
Retention of records for two-years	60.58c(b)
Records of startup. Shutdown, or malfunction	60.7(b)
Documentation produced as a result of siting requirements	60.58c(b)(7)
Records of persons completing review of HMIWI operating manual	60.58c(b)(8)
Records if operators completing operator training course and qualification requirements	60.58c(b)(9), 60.58c(b)(10)
Records of annual testing of fugitives ash emissions	60.58c(b)(2)(ii)
Records of process and control device operating parameters	60.58c(b)(2)(xv), 60.8(f)
Records of emissions or operating parameter exceedances and periods for which data on emissions/operating parameters were not obtained	60.58c(b)(3), 60.8(f)
Records of initial, annual and subsequent performance tests	60.58c(b)(6), 60.8(f)
Records of calibration of any monitoring devices	60.58c(b)(11)
Records of types and amounts of materials charged for co-fired combustors and for incinerators burning only pathological, low-level radioactive, and/or chemotherapeutical waste	60.50c(c)

Electronic Reporting

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

Also, regulatory agencies in cooperation with the respondents continue to create reporting systems to transmit data electronically. However, electronic reporting systems are still not widely used. At this time, it is estimated that approximately 15 percent of the respondents use electronic reporting.

Respondent Activities

Read instructions.

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

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

Write the notifications and reports listed above.

Enter information required to be recorded above.

Develop site-specific operating parameters.

Develop waste reduction plan.

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

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

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

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

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

Transmit, or otherwise disclose the information.

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

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

5(a) Agency Activities

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

Agency Activities

Observe initial performance tests and repeat performance tests if necessary.

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

Audit facility records.

Input, analyze, and maintain data in the Online Tracking Information System (OTIS).

5(b) Collection Methodology and Management

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

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

The records required by this regulation must be retained by the owner or operator for two years.

5(c) Small Entity Flexibility

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

5(d) Collection Schedule

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

6. Estimating the Burden and Cost of the Collection

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

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

6(a) Estimating Respondent Burden

The average annual burden to industry over the next three years from these recordkeeping and reporting requirements is estimated to 6,617 (Total Labor Hours from Table 1). These hours are based on Agency studies and background documents from the development of the regulation, Agency knowledge and experience with the NSPS program, the previously approved ICR, and any comments received.

6(b) Estimating Respondent Costs

(i) Estimating Labor Costs

This ICR uses the following labor rates:

Managerial $105.86 ($50.41 + 110%)

Technical $92.61 ($44.10 + 110%)

Clerical $45.32 ($21.58 + 110%)

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

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

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

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

Capital/Startup vs. Operation and Maintenance (O&M) Costs
(A) Continuous Monitoring Device	(B) Capital/Startup Cost for One Respondent	(C) Number of New Respondents	(D) Total Capital/Startup Cost, (B X C)	(E) Annual O&M Costs for One Respondent	(F) Number of Respondents with O&M	(G) Total O&M, (E X F)
CMS	$2,377	1	$2,377	$2,800	9	$25,200

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

The total operation and maintenance (O&M) costs for this ICR are $25,000 (rounded). This is the total of column G.

The average annual cost for capital/startup and operation and maintenance costs to industry over the next three years of the ICR is estimated to be $27,000 (rounded).

6(c) Estimating Agency Burden and Cost

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

The average annual Agency cost during the three years of the ICR is estimated to be $27,419.

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

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

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

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

These rates are from the Office of Personnel Management (OPM) A2007 General Schedule@ which excludes locality rates of pay. The rates have been increased by 60% to account for the benefit packages available to government employees. Details upon which this estimate is based appear in Table 2: Average Annual EPA Burden, NSPS for Hospital/Medical/Infectious Waste Incinerators (40 CFR Part 60, Subpart Ec), below.

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

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

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

Number of Respondents
Year	(A) Number of 1 New Respondents	(B) Number of Existing Respondents	(C) Number of Existing Respondents That Keep Records But Do Not Submit Reports	(D) Number of Existing Respondents That Are Also New Respondents	(E) Number of Respondents (E=A+B+C-D)
1	2	7	0	1	8
2	2	8	0	1	9
3	2	9	0	1	10
Average	2	8	0	1	9

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

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

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

Total Annual Responses
(A) Information Collection Activity	(B) Number of Respondents	(C) Number of Responses	(D) Number of Existing Respondents That Keep Records But Do Not Submit Reports	(E) Total Annual Responses E=(BxC)+D
Notification of intent to construct	1	1	n/a	1
Notification of actual startup	1	1	n/a	1
Notification of waste to be combusted	1	1	n/a	1
Notification of HMIWI capacity	1	1	n/a	1
Notification of initial performance tests	1	1	n/a	1
Notification of initial CMS demonstration	1	1	n/a	1
Initial report for the site selection analysis	1	1	n/a	1
Waste reduction plan	1	1	n/a	1
Report of initial performance test	1	1	n/a	1
Notification of exemption claimed	1	1	n/a	1
Annual report	8	1	n/a	8
Semiannual reports	8	2	n/a	16
			Total	34

The number of total respondents is nine.

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

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

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

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

(i) Respondent Tally

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

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

(ii) The Agency Tally

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

6(f) Reasons for Change in Burden

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

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

6(g) Burden Statement

The annual public reporting and recordkeeping burden for this collection of information is estimated to average 195 hours per response. Burden means the total time, effort, or financial resources expended by persons to generate, maintain, retain, or disclose or provide information to or for a Federal agency. This includes the time needed to review instructions; develop, acquire, install, and utilize technology and systems for the purposes of collecting, validating, and verifying information, processing and maintaining information, and disclosing and providing information; adjust the existing ways to comply with any previously applicable instructions and requirements; train personnel to be able to respond to a collection of information; search data sources; complete and review the collection of information; and transmit or otherwise disclose the information.

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

To comment on the Agency's need for this information, the accuracy of the provided burden estimates, and any suggested methods for minimizing respondent burden, including the use of automated collection techniques, EPA has established a public docket for this ICR under Docket ID Number EPA-HQ-OECA-2007-0049. An electronic version of the public docket is available at http://www.regulations.gov which may be used to obtain a copy of the draft collection of information, submit or view public comments, access the index listing of the content of the docket, and to access those documents in the public docket that are available electronically. When in the system, select “search” than key in the docket ID number identified in this document. The documents are also available for public viewing at the Enforcement and Compliance Docket and Information Center in the EPA Docket Center (EPA/DC), EPA West, Room 3334, 1301 Constitution Avenue, N.W., Washington, DC. The EPA Docket Center Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Reading Room is (202) 566-1744, and the telephone number for the Enforcement and Compliance Docket and Information Center Docket is (202) 566-1752. Also, you can send comments to the Office of Information and Regulatory Affairs, Office of Management and Budget, 725 17th Street, N.W., Washington, DC 20503, Attention: Desk Officer for EPA. Please include the EPA Docket ID Number EPA-HQ-OECA-2007-0049 and OMB Control Number 2060-0363 in any correspondence.

Part B of the Supporting Statement

This part is not applicable because no statistical methods were used in collecting this information.

Table 1: Annual Respondent Burden and Cost – NSPS for Hospital/Medical/infectious Waste Incinerators (40 CFR Part 60, Subpart Ec)

	(A)	(B)	(C)	(D)	(E)	(F)	(G)	(H)
Burden item	Person- hours per occurrence	No. of occurrences per respondent per year	Person- hours per respondent per year (C=AxB)	Respondents per year (a)	Technical person- hours per year (E=CxD)	Management person-hours per year (Ex0.05)	Clerical person-hours per year (Ex0.1)	Cost ($) (b)
1. Applications	N/A
2. Survey and Studies	N/A
3. Reporting requirements
Non-pathological HMIWI
A. Read instructions	1	1	1	1	1	0.05	0.1	$102.43
B. Required activities
Initial performance test for CMS c	13	1	13	1	13	0.65	1.3	$1,331.66
Repeat performance test CMS c	13	1	13	0.2 d	2.6	0.13	0.26	$266.33
Development of operating information e	160	1	160	1	160	8	16	$16,389.60
Annual update of operating information f	20	1	20	8 g	160	8	16	$16,389.60
Review of operating information with each operator h	8	2	16	9	144	7.2	14.4	$14,750.64
C. Create information	See 3B
D. Gather existing information	See 3B
E. Write report
Non-pathological HMIWI
Notification of intent to construct	2	1	2	1	2	0.1	0.2	$204.87
Notification of actual startup	2	1	2	1	2	0.1	0.2	$204.87
Notification of waste to be combusted	2	1	2	1	2	0.1	0.2	$204.87
Notification of HMIWI capacity	2	1	2	1	2	0.1	0.2	$204.87
Notification of initial performance test	2	1	2	1	2	0.1	0.2	$204.87
Notification of initial CMS demonstration	2	1	2	1	2	0.1	0.2	$204.87
Initial report for the site selection analysis i	460	1	460	1	460	23	46	$47,120.10
Waste reduction plan j	160	1	160	1	160	8	16	$16,389.60
Report of initial performance test k	40	1	40	1	40	2	4	$4,097.40
Report of initial CMS demonstration	See 3B
Semiannual reports l	74	2 n	148	8 m	1,184	59.2	118.4	$121,283.04
Annual reports	64	1 n	64	8	512	25.6	51.2	$52,446.72
Pathological and co-fired combustors
Notification of relative amounts of hospital, medical/infectious and other waste charged	2	1	2	8	16	0.8	1.6	$1,638.96
Notification of exemption claim	2	1	2	8 o	16	0.8	1.6	$1,638.96
F. Time to enter information
(Non-pathological HMIWI)
Records of startup, shutdown or malfunction	2	52	104	9	936	46.8	93.6	$95,877.16
Records of persons completing review	2	2	4	9	36	1.8	3.6	$3,687.66
Records of annual testing fugitive emissions	See 3E
Records of process and control device	1.5	52	78	9	702	35.1	70.2	$105,350.54
Records of CMS operations and maintenance	0.2	272 q	54.4	9	489.6	24.48	48.96	$50,152.18
Records of emissions exceedances	1.5	52	78	9	702	35.1	70.2	$105,350.54
Records of annual compliance tests	See 3E
5. Recordkeeping requirements
A. Read instructions	See 3A
B. Plan activities	N/A
C. Implement activities	N/A
D. Develop record system	N/A
E. Time to enter information
Non-pathological HMIWI
Documents produced as a result of siting requirements	See 3E
Records of operators training completion	2	2 h	4	1	4	0.2	0.4	$409.74
Records of HMIWI qualified operators	2	2 h	4	1	4	0.2	0.4	$409.74
Records of initial performance test	See 3E
F. Time to train personnel	N/A
G. Time for audits	N/A
Subtotal					5,754.2	287.71	574.62	$656,311.82
TOTAL ANNUAL BURDEN AND COST (rounded)						6,617		$656,312

Assumptions:

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

^b. This ICR uses the following labor rates: $105.86 per hour for Executive, Administrative, and Managerial labor; $92.61 per hour for Technical labor, and $45.32 per hour for Clerical labor. These rates are from the United States Department of Labor, Bureau of Labor Statistics, December 2006, “Table 2. Civilian Workers, by occupational and industry group.” The rates are from column 1, “Total compensation.” The rates have been increased by 110 percent to account for the benefit packages available to those employed by private industry.

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

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

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

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

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

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

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

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

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

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

^m. Respondents must submit semiannual reports.

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

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

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

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

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

	(A)	(B)	(C)	(D)	(E)	(F)	(G)	(H)
Activity	EPA person- hours per occurrence	No. of occurrences per plant per year	EPA person- hours per plant per year (C=AxB)	Plants per year (a)	Technical person- hours per year (E=CxD)	Management person-hours per year (Ex0.05)	Clerical person-hours per year (Ex0.1)	Cost ($) (b)
Activity
1. Attend initial performance test	32	1	32	0.08c	2.56	0.128	0.256	$123.94
2. Repeat performance test
A. Retesting preparation	12	1	12	0.2d	2.4	0.12	0.24	$116.20
B. Attend retesting	32	1	32	0.1e	3.2	0.16	0.32	$154.92
3. Excess emissions	32	1	32	0.1f	3.2	0.16	0.32	$154.92
4. Report review
Review notification of intent to construct	2	1	2	1	2	0.1	0.2	$96.83
Review notification of actual startup	2	1	2	1	2	0.1	0.2	$96.83
Review notification of type(s) of waste to be combusted	2	1	2	1	2	0.1	0.2	$96.83
Review notification of HMIWI capacity	2	1	2	1	2	0.1	0.2	$96.83
Review notification of initial performance test	8	1	8	1	8	0.4	0.8	$387.32
Review notification of initial CMS demonstration	5	1	5	1	5	0.25	0.5	$242.07
Review notification of relative amounts of hospital, medical/infectious, and other waste charged for pathological and co-fired combustors	2	1	2	8g	16	0.8	1.6	$774.64
Review notification of exemption claim for pathological and co-fired combustors	2	1	2	8g	16	0.8	1.6	$774.64
Review study addressing siting requirements	24	1	24	1	24	1.2	2.4	$1,161.96
Review waste reduction plan	8	1	8	1	8	0.4	0.8	$387.32
Review report of initial performance test	42h	1	42	1	42	2.1	4.2	$2,033.43
Review report of initial CMS demonstration	64i	1	64	1	64	3.2	6.4	$3,098.56
Review notification of exemption claim	1	1	1	1	1	0.05	0.1	$48.42
Review performance tests results	18	1	18	8j	144	7.2	14.4	$6,728.82
Review annual report	4	1	4	8	32	1.6	3.2	$1,549.28
Review semiannual reports	12	2 k	24	8j	192	9.6	19.2	$9,295.68
TOTAL ANNUAL BURDEN AND COST (rounded)						657		$27,419
Assumptions:
a. We have estimated that an average of nine facilities have been built or reconstructed after June 20, 1996, and therefore, are subject to NSPS subpart Ec. It is estimated that one additional respondent will become subject over the next three years.
b. The cost is based on the following labor rate which incorporates a 1.6 benefits multiplication factor to account for government overhead expenses. Managerial rates of $58.18 (GS-13, Step 5, $36.36x1.6), Technical rate of $43.17 (GS-12, Step 1, $26.98 x 1.6), and Clerical rate of $23.36 (GS-6, Step 3, $14.60 x 1.6). These rates are from the Office of Personnel Management (OPM) “2007General Schedule” which excludes locality rates of pay.
c. Each year a total of one HMIWI performs an initial performance test. It is assumed that EPA personnel will attend eight percent of these tests.
d. It is assumed that 20 percent will fail the initial performance test, and will have to repeat the test. e. Assume 10 percent of retests are attended by EPA personnel. f. Assume 10 percent of the affected facilities are required to retest as a result of excess emissions, with 10 percent of these tests being attended by EPA personnel. g. Assume that an additional six sources (pathological and co-fired combustors) are also projected each year, but are considered exempt from the rule. It is assumed that there will be one affected facility per respondent. h. Assume it takes six persons-hours per report to review each pollutant. For initial tests there are seven pollutants that are subject to this rule (PM, CO, CDD/CDF, HCI, metals, stack opacity, and fugitive emissions. i. Assume it takes eight person-hours per report to review each CMS demonstration. There are eight CMS that are subject to this rule (temperature, gas flow, charge weight, pH, liquid flow, pressure drop, carbon flow, and lime flow). j. This activity will not be performed for the first year of a new source. k. Respondents must submit semiannual reports.