### 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 Incinerat ors (40 CFR Part 60, Subpart Ce and 40 CFR Part 62, Subpart HHH) (Renewal), EPA I CR Number 1899.0 7 , OMB Control Number 2060

- 0422 **1(b) Short Characterization/Abstract** Th e State and Federal Emission Guidelines for Hospital/Medical/Infectious Waste In cinerators were promulgated on September 15, 1997 (subpart Ce) and September 14, 2000 (subpart HHH), and re vised on October 6, 2009

. Subpart Ce requires either states or tribes to develop plans to impl ement the Emission Guidelines. If approvable state or tribal plans were not developed, the EPA was required to develop a Federal plan ( subpart HHH ) to implement the Emission Guidel ines for such states and tribes. States and tribes may choose to impose requi rements that are more stringent, h owever, the burden estimates provided in this I CR assume that the state and tribal plans mirror the Emission Guidelines. This information is being collected to assure compliance with 40 CFR part 60, subpart Ce and 40 CFR part 62, Subpart HHH

. In general, the Emission Guidelines require initial notifications, performance tests, and periodic reports by

the owners/operators of the affected facilities. They are also required to maintain records of the occurrence and duration of an y startup, shutdown, or malfunction in the operation of an affected facility , or any period during which the monitoring sy stem is inoperative. These notifications, reports, and records are essential in determining compliance, and are required of all affected facilities subject to the Emission Guidelines

. Any owner/operator subject to the provisions of this part shall maintain a file of these measure ments, 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 rep orts are sent directl y to the U.S. Environmental Protection Agency (EPA) regional office. Over the next three ye ars, an average of 79 existing sources located at 73 different facilities will be subject to the standard and no additional respondents per y ear will become subject to the standard

. An estimated 47 of these sources are owned and operated b y the private sector (hospitals, commercial waste disposal companies, pharmaceutical companies, and private universities); 6 are owned and operated b y the Federal government (U.S. military base, veterans hospitals, and Federal research facilities); and 4 are owned and operated b y State or local

### governments (State universities) , and 22 States that require annual State Plan Inventory

.

This I CR 1899.07 is being combined with I CR number 2335.02, (OMB control number 2060

- 0628)

. The number of existing sources is increased from 57 to 79 ; the latter number includes 22 States who must report their annual update of State Plan Inventory. The Office of Manageme nt and Budget (OMB) approved the currentl y active I CR without any

“Terms of Clearance.” Hospital/Medical/Infectious Waste Incinerators (HMIWI ) in the United States are owned and operated b y either the private sector, the Federal government, or state and local governments (the “Affected Public”). The burden to the “Affected Public” may be found below 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)

. The burden to the “Federal Government” burden is attributed entirel y to work performed b y either F ederal employ ees or government contractors and may be found below in Ta ble 2: Average Annual EPA Burden and Cost

– S tate and Federal Emission Guidelines for Hospital/Medical /Infectious Waste Incinerators (40 CFR Part 60, Subpart Ce and 40 CFR Part 62, Subpart HHH) (Renewal)

. **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 an y existing source for an y air pollutant (i) for which air qualit y 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 thi s 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 qualit y health and environmental impacts and energy requirements, determines is achievable for new o r 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 applicab le to existing units. Such guidelines shall include, as provided in this section, each of the elements required by subsection (a) (emissions limitations, notwithstanding an y 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 emi ssion 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 inf ormation necessary

for the purposes set forth in this subsection, or who is subject to an y 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, periodi c or continuous basis to

- (A) establish and maintain such records; (B) make such reports; (C) install, use, and maintain such monito ring equipment, and use such audit procedures, or methods; (D) sample such emissions (in accordance with such procedures or methods, at such locations, at such

### 4 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), dioxin/furans (D/F), h ydrogen chloride (HCl), sulfur dioxide (SO 2 

### ), nitrogen oxide (NO x 

### ), lead (Pb), cadmium (Cd), and mercury (Hg) emissions from hospital, medical, or infectious waste incinerators cause or contribute to air pollution that may reasonabl y 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 s ensure compliance with the applicable regulations which where promulgated in accordance with the Clean Air Act. The collected information is also used for targeting i nspections and as evidence in legal proceedings. Performance tests are required in order to determine an affected facility ’ s initial capability to comp ly

with the emission standards. Continuous em ission monitors are used to ensure compliance with the standards at all times. During the performance test 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 standards are used to inform the Agency or delegated authority when a source becomes subject to the requirements of the regulations. The reviewing authority may then inspect the source to check if the pollution control devices are properl y installed and operate d, leaks are being detected and repaired, and the standards are being met. The performance test may also be observed. The required semiannual reports are used to determine periods of excess emissions, identify problems at the facility , verify operation/m aintenance procedures and for compliance determinations. **3. Non**
**- duplication, 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

.

### 5

**3(a) Non** 
**- duplication**  If the subject standards have not been delegated, the information is sent directl y to the appropriate EPA regional office. Otherwise, the information is sent directl y to the delegated state or local agency . If a state or local agency has a dopted its own similar standards to implement the Federal standards, a cop y 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, duplication does not exi st. **3(b) Public Notice Required Prior to ICR Submission to OMB** An announcement of a public comment period for the renewal of this I CR was published in the Federal Register ( 76 FR 26900) on May 9, 2011. No comments were received on the burden published in the Federal Register

. **3(c) Consultations** The Agency

has consulted i ndustry

experts and internal data sources to project the number of affected facilities and industry growth over the next three y ears. 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 Sy stem (OTIS) which is operated and maintained b y EPA's Office of Compliance. OTI S is EPA’s 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. Industry trade associations and other interested partie s were provided an opportunity to comment on the burden associated with the standard as it was being developed and the standard has been previously

reviewed to determine the minimum information n eeded for compliance purposes. In developing this I CR, we co ntacted : 1) the Healthcare Waste Institute (HWI) , at ( 202 ) 364

- 3724 ; and 2) the Larson

- Miller Medical Waste Disposal Service , at ( 801) 738

- 6545

. 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 frequentl y, the pr oper operation and maintenance of control equipment and the possibility

of detecting violations would be less likely

.

### 6

**3(e) General Guidelines** T hese reporting or recordkeeping requirements do not violate any of the regulations promulgated by OMB under 5 CFR part 1320, section 1320.5. These standards require the respondents to maintain all records, including reports and notifications for at least five y ears. This is consistent with the General Provisions as applied to the standards. EPA believes that the five

- ye ar records retention requirement is consistent the Part 70 permit program and the five

- ye ar statute of limitations on which the permit program is based. Th e retention of records for five ye ars allows EPA to establish the compliance history of a source, an y pattern of non

- compliance and to determine the appropriate level of enforcement action. EPA has found that the most flagrant violators have violations extending bey ond five ye ars. In addition, EPA would be prevented from pursuing the violat ors 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, chapte r 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** T he reporting or recordkeeping requirements in the standard do not include sensitive questions. **4. The Respondents and the Information Requested 4(a) Respondents/SIC Codes**  The respondents to the recordkeeping and reporting requirements are owners and operators of HMIWIfor which construction commenced on or before the date of the rule proposal . The United States Standard Industrial Classification (SI C ) code s for the respondents affected b y the standards and the correspond ing North American Industry Classification Sy stem (NAICS ) codes are listed below for the HM IW I source category

. Not all processes classified in these NAICS codes are subject to the e mission guidelines.

**Standard (40 CFR**  **P art 60,**  **S ubpart Ce and**  **40 CFR P**  **art 62,**  **S ubpart HHH)**  **SIC Codes NAICS Codes**  General Medical and Surgical Hospitals 8062, 8069 622110 Specialty Hospitals 8069 622310

### 7

**Standard (40 CFR**  **P art 60,**  **S ubpart Ce and**  **40 CFR P**  **art 62,**  **S ubpart HHH)**  **SIC Codes NAICS Codes**  Medicinal and Botanical Manufacturing 2833 325411 Pharmaceutical Preparation Manufacturing 2834 325412 Solid Waste Combustors and Incinerators 4953 562213 Colleges, Universities, and Professional Schools 8221 611310 Research and Development in Phy sical, Chemical, and Life Sciences 3721, 3724, 3728, 3761, 3764, 3769, 8731, 8733 54171 0
National Securit y 9711 928110 Public Health Facility 9431 923120 Nursing and Personal Care Facilities 8051, 8052, 8059 623110, 62 33 11 Veterinary

Services 0741, 0742, 8734 541 940 **4(b) Information Requested (i) Data Items**  In this ICR , all the data that is recorded or reported is required b y State and Federal Emission Guidelines for Hospital/Medical/Infectious Waste Incinerat ors (40 CFR P art 60, S ubpart Ce and 40 CFR P art 62, S ubpart HHH)

. A source must make the following reports:
**Notifications** State Plan to implement and enforce emission guidelines 60.39e(a), 60.23(a) Notification of public hearing on State Plan 60.23(d) Certification that public hearing on State Plan conducted according to subpart B State procedures 60.23(f)
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 In crements of progress for HMIWIthat will comply with regulation 60.39e(c) Request for extension to shut down late 60.39e(d)

### 8 **Notifications** Waste management plan 60.35e, 60.353(a), 60.38e(a), 60.55c(c), 60.58c(c), 62.14430 Notification of HMIWIcapacit y 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 of initial performance test 60.38e(a), 60.58c(c), 60.8 (a), 60.58c(d)(6), 62.14463(a) Initial report of v alues 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( d)

– ( f) Annual report of the highest maximum and lowest minimum operating parameters (covering the last two ye ars) 60.38e(a), 60.58c(d), 62.14463(d) Annual and semiannual report s of emissions or operating parameter exceedances, malfunctions, and periods for which data on emissions/operating parameters were not obtained 60.38e(a), 60.58c(d

- e ), 60.7(c

d), 62.14463(g) , 62.14464(b

- c)
Annual report containing results of annual performance test 60.38e( a - b), 60.58c(d), 62.14463(h), 62.14464(b) Annual report of no excess emissions, malfunctions, or operating parameter exceedances 60.38e(a), 60.58c(d), 60.7(c), 62.14463(i) Results of previous performance tests 60.37e(f) , 60.38e(a) Any use of the by

pass stack, duration, reason for malfunction, and corrective ac tion taken 60.38e(a), 60.58c(d), 62.14463(j) Annual update of operating information 60.34(e), 60.53c(i), 62.14423(c)

### 9 **Notifications** Annual review of operating information with each operator 60.34(e), 60.53c(h), 6214425(a) A source must keep the following records: **Recordkeeping** Records of public hearing conducted on State Plan 60.23(e) Retention of records for 5 y ears 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

- b ) Records on a quarterl y basis of periods, when only pathological, low

- level radioactive, and/or chemotherapeutical waste is burned. 60.32e(b

- c ), 62.14400 Records of quarterl y 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

- e ) 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 an y subsequent performance tests 60.38e(a), 60.58c(b), 60.8(f), 62. 14460(f) Records of persons completing reviews of HM IW I 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) Rec ords of operators who have met the qualification requirements 60.38e(a), 60.58c(b), 62.14460( h

- i) Records of calibration of any monitoring devices 60.38e(a), 60.58c(b), 62.14460(j)

### 10 **Recordkeeping** Records of emissions, process, and control device operating parameters 60.38e(a), 60.58c(b), 60.8(f), 62.14460(a) and (b)(2

- 12) Records of initial testing of fugitive ash emissions 60.38e(a) , 60.58c(b)(2)(ii) Electronic Reporting Some of the r espondents are using monitoring equipment that automat ically 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 c ooperation with the respondents continue to create reporting sy stems to transmit data electronically . However, electronic reporting s ys t ems are still not widely used. At this time, it is estimated that approximately 1 5 percent of the respondents use ele ctronic reporting.

**(ii) Respondent Activities**

**Respondent Activities** Read instructions. Develop State Plan and inventory and update inventory

annually

. Conduct public hearing on State Plan. Install, calibrate, maintain, and operate CMS for opacity , or for pressure drop and liquid supply pressure for control device. Perform CMS demonstrations and repeat CMS demonstrations if necessary. Perform initial performance test s and repeat performance tests if necessary

. Develop, update, and review operating information. Perform inspections. Write the notifications and reports listed above. Develop waste management plan. Prepare and review reports of performance tests and CMS demonstrations. Submit the required reports developing, acquiring, installing, and utilizing technology and

### 11 **Respondent Activities** sy stems for the purpose of collecting, validating, and verifying information. Develop, acquire, install, and utilize technology and sy stems for the purpose of processing and maintaining information. Develop, acquire, install, and utilize technology and sy stems for the purpose of disclosing and providing information. Complete operator training and qualification. Train personnel to be able to respond to a collection of information. Maintain the records listed in the table above. Transmit, or otherwise disclose the information. Currently , sources are using monitoring equipment and reporting equipment that provides parameter data in an automated way (e.g., continuous parameter monitoring s ys tem). Although personnel at the source still need to evaluate the data, this ty pe of monitoring equipment has significantl y reduced the burden associated with monitoring and recordkeeping.
**5. The I nformation Collected: Agency Activities, Collection Methodology, and**  **Information Management 5(a) Agency Activities**  EPA conducts the following activities in connection with the acquisition, analy sis, storage, and distribution of the required information. **Agency Activities** Observe initial performance tests and repeat performance tests if necessary

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

. Audit facility

records. Input, anal yz e, and maintain data in the Online Tracking Information Sy stem (OTI S). **5(b) Collection Methodology and Management** Following notification of startup, the reviewing authority could inspect the source to determine whether the pollution control devices are properl y installed and operated.

### 12

Performance test reports are used b y the Agency to discern a source’s initial capab ility to compl y with the emission standard. Data and records maintained by the respondents are tabulated and published for use in compliance and enforcement programs. The semiannual reports are used for problem identification, as a check on source operat ion and maintenance, and for compliance determinations.
In formation contained in the reports is entered into OTI S which is operated and maintained by

EPA's Office of Compliance. OT IS is EPA ’ s database for the collection, maintenance, and retrieval of compliance data for approximately 125,000 industrial and government

- owned facilities. EPA uses the OTI S for tracking air pollution compliance and enforcement b y local and state regulatory agencies, EPA regional offices and EPA headquarters. EPA and its dele gated Authorities can edit, store, retrieve and analyze the data. The records required b y this regulation must be retained by the owner/operator for five ye ars. **5(c) Small Entity Flexibility** A 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 ty pes of control equipment e mploy ed, 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 th em further for small entities. How ever, the regulation includes various provisions that would reduce the burden on HMIWI , including the two HMIWIwithin the respondent universe that ar e classified as small entities. For example, there are provisions allowing HMIWI to skip annual tests and test reports for 2

- ye ar periods if they have demonstrated compliance f or three annual tests in a row. Also, the emission guidelines allow HMIWIto submit previous emission tests to demonstrate compliance with the emission limits in the revised guidelines

. **5(d) Collection Schedule** The specific frequency

for each information collection activity within this request is shown in below Table 1: Annual Respondent Burden and Cost

– State and Federal Emission Guidelines for Hospital/Medical/Infectious Waste In cinerators (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 each of the subparts included in this I CR. The individual burdens are expressed under standardized headings believed to be consistent with the concept of burden under the Paperwork Reduction Act. Where ver appropriate, specific tasks and major ass umptions have been identified. Responses to this information collection are

### 13

mandatory

. The Agency

may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it display s a currently valid OMB Contr ol Number. **6(a) Estimating Respondent Burden** The average annual burden to industry over the next three y ears from these recordkeeping and reporting requirement s is estimated to be 60 , 0 80 hours ( Total Labor Hours from Table 1 below ). T hese hours are based on Agency studies and background documents from the development of the regulation, Agency knowledge and experience with part 60 and part 62 regulations , the previously approved ICR, and any comments received. **6(b) Estimating Respondent Costs (i)**  **Estimating Labor Costs** This I CR uses the following labor rates:

Industry State Government Managerial $ 120.77 ($ 57.51 + 110%) $66.98 ($41.86 + 60%) Technical $ 99.39 ($ 47.33 + 110%) $52.13 ($32.58 + 60%) Clerical $ 50.04 ($ 23.83 + 110%) $24.35 ($15.22 + 60%) The industry rates are from the United States Department of Labor, Bureau of Labor Statistics, December 201 1 , “ Table 2. Civilian Workers, by occupational and industry group. ” The rates are from column 1, “ Total compensation. ” The rates have been increased b y 110 percent to account for the benefit packages available to those employ ed by private industry

. Rates for the State government are from the United States Department of Labor, Bureau of Labor Statistics, May 2011 Nationa l Industry

- Specific Occupational Employ ment and Wage Estimates for State government (NAI CS code 999200). The rates have been increased b y 60 percent to account for the benefit packages available to State government employ ees .

**(ii) Estimating Capital/Startup and Operation and Maintenance Costs**  The ty pe of industry

costs associated with the information collection activities in the subject standards are both labor costs which are addressed elsewhere in this I CR and the costs associat ed with cont inuous 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 monitors and other costs such as photocopying and postage.

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

### 14 **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) **Monitoring costs**

- Privately

- owned HMIWI $3,751 0 $0 $11,957 47 $562,000

- Federally owned HMIWI $3,700 0 $0 $8,317 6 $49,900

- State/locally

- owned HMIWI $3,700 0 $0 $6,275 4 $25,100 Testing 1 $21,000 0 $0 NA 0 $0 File Cabinets 2 $33.5 0 0 $0 NA 0 $0 **Photocopying and postage**

- States N/A 0 $0 $16.27 22 $358

- Privately

- owned HMIWI N/A 0 $0 $50.28 47 $2,363

- Federally owned HMIWI N/A 0 $0 $49.67 6 $298

- State/locally

- owned HMIWI N/A 0 $0 $49.50 4 $198 **Temperature pressure, flow rate, change rate, voltage, and pH monitors 3** 

- Privately

- owned HMIWI N/A 0 $0 $1,800 47 $84,600

- Federally owned HMIWI N/A 0 $0 $1,800 6 $10,800

- State/locally

- owned HMIWI N/A 0 $0 $1,800 4 $7,200 **Subtota l**  **s**

- States $0 $358

- Privately

- owned HMIWI $0 $648,963

- Federally owned HMIWI $0 $60,998

- State/locally

- owned HMIWI $0 $32,498 **TOTAL $742,817** 
Note: This I CR assumes that all existing respondents have already installed monitoring and testing equipment to comply with t he emission guidelines, including equipment for in

- house testing of fugitive ash emissions required by the revised emission guideli nes. Therefore, there is no capital/startup costs associated with this ICR. 1 Average testing cost for all respondents 2 Annualized cost with a capital recovery factor of 0.14238 based on a 10

- year equipment life and a 7 percent interest rate, assuming each facility will purchase one standard four

- drawer file cabinet ($235 per cabinet). 3 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.

### 15

The total capital/startup costs for this I CR are zero. This is the total o f column D in the above table. The total operation and maintenance (O&M) costs for this I CR are $ 742,817

. 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 y e ars of the IC R is estimated to be $ 742,817

. These are recordkeeping costs. **6(c) Estimating Agency Burden and Cost** The only costs to the Agency

are those costs associated with anal ys i s of the reported information. EPA's overall compliance and enforcement program i ncludes 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 th e three y ears of the ICR is estimated to be $1 31 , 043

. This cost is based on the average hourl y labor rate as follows: Managerial $62.27 (GS

- 13, Step 5, $38.92 + 60%) Technical $46.21 (GS

- 12, Step 1, $28.88 + 60%) Clerical $25.01 (GS

- 6, Step 3, $15.63 + 60%) These rates are from the Office of Personnel Management (OPM), 2011 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 employ ees . Details upon which this estimate is based appear below in Table 2: Average Annual EPA 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) (R enewal). **6(d) Estimating the Respondent Universe and Total Burden and Costs** Based on our research for this I CR, on average over the next three ye ars, approximately 79 existing respondents (47 privately

- owned, 6 Federall y - owned, and 4 State/locally

- owned HMIWIresiding in 22 States , plus the individual 22 states. ) will be subject to the standard. It is estimated that no additional respondents per y ear will become subject. The overall average number of respondents, as shown in the table belo w is 7 9 per year. The number of respondents is calculated using the following table that addresses the three ye ars covered b y this ICR.

### 16 **Number of Respondents**

Year (A) Number of Ne w 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 79 0 0 79
2 0 79 0 0 79 3 0 79 0 0 79 Average 0 79 0 0 79 1 New respondent include sources with constructed, reconstructed and modified affected facilities

.



### . C olumn D is subtracted to avoid double

- counting respondents

. As shown above, the average Number of Respondents over the three ye ar period of this ICR is 79

. The total number of annual responses per ye ar is calculated using the following table:

### 17
**(A) Inform**  **ation Collection Activity States**  **Privately**
  ** Owned** **HM IWI**  **Federally**
 

** Owned** **HM IWI**  **State/Locally**

**Owned HM**  **IWI Total** 

State Plan/inventory 1 0 0 0 0 0 Annual update of State Plan inventory 22 0 0 0 22 Notification of initial performance test and CMS demonstration N/A Annual Reports 2 CMS emissions and operating parameters 0 47 6 4 57 Exceedances, malfunctions, and periods for which data not obtained 0 9.4 1.2 0 .8 11.4 Results of performance tests conducted during the year 0 47 6 4 57 Report of no exceedances 0 37.6 4.8 3.2 45.6 Report of annual equipment inspection (small rural HMIWI) 0 2 0 0 2
Semiannual report of exceedances, malfunctions, and periods for which data not obtained 3 0 9.4 1.2 0.8 11.4

**Total 22**  **152.4 19.2**  **12.8 206.4** 
1 This ICR assumes all 22 states have approved State Plans by the first year this ICR. 2 This ICR assumes 20% of respondents report exceedances, and 80% of respondents report no exceedances. 3 Because the semiannual report coincides once each year with the annual report and both reports include information on exceedances, malfunctions, and p eriods for which data were not obtained, the frequency of the semiannual report is shown in the table as only once per year to avoid double

- counting. 

### The number of Total Annual Responses is approximately 2 0 6 (rounded) , ( 22 for States, 152.4 for privatel y - owned HMIWI , 19.2 for Federally

- owned HMIWI, and 12.8 for State/locall y owned HMIWI

. The total annual labor costs are $ 5 , 7 46 , 349

. Details regarding these estimates may be found below 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)

. **6(e) Bottom Line Burden Hours and Cost Tables** The detailed bottom line burden hours and cost calculati ons for the respondents and the Agency are shown in Tables 1 and 2, respectivel y, and summarized below.

### 18 **(i) Respondent Tally** The total annual labor hours are 60 , 0 80

. Details regarding these estimates may be found below 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 29 2 (rounded) hours per response

. The total annual capital/startup and O&M costs to the regulated entity are $ 742 , 817

. The cost c alculations are detailed in Section 6(b)(iii), Capital/Startup vs. Operation and Maintenance (O&M) Costs. **(ii) The Agency Tally** The average annual Agency burden and cost over next three y ears is estimated to be 2 , 908 labor hours at a cost of $1 31 , 043 . See below Table 2: Average Annual EPA 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 decrease in the total estimated burden as currentl y identified in the OM B Inventory of Approved B urdens. The decrease is not due to any program changes. The most recentl y approved ICR (ICR 1899.06) estimated the total burden associated with the regulation by adding together the burdens and costs from the ICR for the existing standard (ICR 1899.05) and the revised standard (I CR 2335.02) ; portions of the rule requirements and burden activities in I CR s 1899.06 and 233 5 .02 overlap

. This ICR u pdat es all estimates and removes an y duplicate burdens. There is no capital/startup cost associated with this I CR, which is a decrease from the most recentl y approved ICR. There are also changes in the O&M costs in this I C R compared to the previous ICR. Th ese changes occurred because the most recently revised standard has been in effect for more than three ye ars and the requirements are different during initial compliance as c ompared to on

- going compliance. This I CR does not include the costs and burden fo r conduct ing initial comp liance tests and notifications. Additionally , this ICR assumes that all sources have alread y purchased monitoring and testing equipment to comply with the standard. **6(g) Burden Statement** The annual public reporting and recordk eeping burden for this collection of information is estimated to average 29 2 hours per response. Burden means the total time, effort, or financial resources expended b y 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,

### 19

acquire, install, and utilize technology and s ys tems for the purposes of collecting, validating, and verifying information, processing and maintaining information, and disclosi ng and providing information; adjust the existing way s to compl y 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 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 t his I CR under Docket ID Number EPA

–HQ

– OECA

–2011

– 0272. 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 contents of the docket, and to access those documents in the public docket that are available electronically . When in the sy stem , select “search,” then key in the docket ID number identified in this document. The documents are al so 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 Ave., NW, 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 holiday s. The telephone number for the Reading Room is (202) 566

- 1744, and the telephone number for the docket center i s (202) 566

- 17 52

. Also, you can send comments to the Office of In formation and Regulatory Affairs, Office of Management and Budget, 725 17th Street, NW, Washington, DC 20503, Attention: Desk Officer for EPA. Please include the EPA Docket ID Number EPA

–HQ

– OECA

–2011

– 0272 and OMB Control Number 2060

- 0422 in any correspondence. **Par t B of the Supporting Statement**  This part is not applicable because no statistical methods were used in collecting this information.

### 20

**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)**

**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 (States)** A. Read instructions 1 1 1 0 0 0 0 $0 B. Required activities c

- Development of State Plan/I nventory 2 , 080 1 2 , 080 0 0 0 0 $0

- Annual update of State Plan I nventory 20 1 20 22 440 22 44 $25,481.28

- Public hearing on State Plan 8 1 8 0 0 0 0 $0 C. Create information Incl. in 3B D. Gather information Incl. in 3B E. Write report

- State Plan/I

nventory Incl. in 3B

- Annual update of State Plan I nventory Incl. in 3B

- Notification of public hearing on State Plan 8 1 8 0 0 0 0 $0

- Certification that public hearing on State Plan conducted according to Subpart B State procedures 2 1 2 0 0 0 0 $0 **Subtotal for Reporting Requirements (States) 506**  **$25,481.28 4. Reporting requirements (privately** 
**- owned**  **HMIWI)** A. Read instructions d 40 1 40 0 0 0 0 $0 B. Required activities e In stallation of CMS 15 1 15 0 0 0 0 $0 Performance specification tests for CMS 8 1 8 0 0 0 0 $0 Repeat performance specification tests/CMS 8 1 8 0 0 0 0 $0 In itial equipment inspection (small rural HMIWI) 20 1 20 0 0 0 0 $0 Annual update of operating information f 20 1 20 47 940 47 94 $103,806.55 Review operating information with each operator g 8 2 16 47 752 37.6 75.2 $83,045.24 Annual equipment inspection (small rural HMIWI) 20 1 20 2 40 2 4 $4,417.30 Annual equipment inspection (all other HMIWI) 20 1 20 45 900 45 90 $99,389.25

### 21

C. Create information See 3B Development of operating information h 160 1 160 0 0 0 0 $0 D. Gather information Incl. in 4B E. Write report e In crements of progress for HMIWI that will Comply Control plan 24 1 24 0 0 0 0 $0 Notification of construction contracts 2 1 2 0 0 0 0 $0 Notification of construction commencement 2 1 2 0 0 0 0 $0 Notification of construction completion 2 1 2 0 0 0 0 $0 Notification of control plan completion 2 1 2 0 0 0 0 $0 Request for extension to shut down date 12 1 12 0 0 0 0 $0 Notification of initial performance test 2 1 2 0 0 0 0 $0 Notification of initial CMS demonstration 2 1 2 0 0 0 0 $0 Waste management plan 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) 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

- rura l, medium, and large HMIWI) 640 1 640 0 0 0 0 $0 Report of initial CMS demonstration See 4B Annual report CMS operating parameters 32 1 32 47 1 , 504 75.2 150.4 $166,090.48 Emissions/parameter exceedances and periods when emission/parameter data not obtained j

- Small rural HMIWI 16 1 16 0.4 6.4 0.32 0.64 $706.77

- All other HMIWI 64 1 64 9 576 28.8 57.6 $63,609.12 Report of annual performance test

- Small rural HMIWI 20 1 20 2 40 2 4 $4,417.30

- All other HMIWI 280 1 280 45 12,600 630 1,260 $1,391,449.50 Report of no exceedances

- Small rural HMIWI 8 1 8 1.6 13 0.6 5 1.3 $1,413.54

- All other HMIWI 32 1 32 36 1,152 57.6 115.2 $127,218.24 Report of annual equipment inspection See 4B Semiannual report of emissions/parameter exceedances and periods when emission/parameter data not obtained (small non

- rural, medium, and large HMIWI) j 32 2 64 9 576 28.8 57.6 $63,609.12 Semiannual report of emissions/parameter exceedances and periods when emission/parameter data not obtained (small rural HMIWI) j 8 2 16 0.4 6.4 0.32 0.64 $706.77 **Subtotal for Reporting Requirements (Privately**
**- owned**  **HMIWI) 21,971**  **$2,109,879.17**

### 22

**5. Reporting requirements (Federally**
**- owned HMIWI)**  A. Read instructions e 1 1 1 0 0 0 0 $0 B. Required activities Annual update of operating information f 20 1 20 6 120 6 12 $13,251.90 Review operating information with each operator g 8 2 16 6 96 4.8 9.6 $10,601.52 Annual control equipment inspection 20 1 20 6 120 6 12 $13,251.90 C. Create information NA D. Gather existing information Incl. in 5B E. Write report Annual report CMS operating parameters 32 1 32 6 192 9.6 19.2 $21,203.04 Emissions/parameter exceedances and periods when emission/parameter data not obtained j 64 1 64 1.2 76.8 3.84 7.68 $8,481.22 Report of annual performance test 40 1 40 6 240 12 24 $26,503.80 Report of no exceedances 32 1 32 4.8 153.6 7.68 15.36 $16,962.43 Report of annual equipment inspection Incl. in 5B Semiannual report of emissions/parameter exceedances and periods when emission/parameter data not obtained j 32 2 64 1.2 76.8 3.84 7.68 $8,481.22 **Subtotal for Reporting Requirements (Federally**
**- owned HMIWI)**  **1,236 $118,737.02**  **6. Reporting requirements (State/locally**
**- owned HMIWI)**  A. Read instructions e 1 1 1 0 0 0 0 $0 B. Required activities 0 0 0 $0 Annual update of operating information 20 1 20 4 80 4 8 $8,834.60 Review operating information with each operator 8 2 16 4 64 3.2 6.4 $7,067.68 Annual control equipment inspection 20 1 20 4 80 4 8 $8,834.60 C. Create information NA D. Gather existing information Incl. in 6B E. Write report Annual report CMS operating parameters 32 1 32 4 128 6.4 12.8 $14,135.36 Emissions/parameter exceedances and periods when emission/parameter data not obtained j 64 1 64 0.8 51.2 2.56 5.12 $5,654.14 Report of annual performance test 40 1 40 4 160 8 16 $17,669.20 Report of no exceedances j 32 1 32 3.2 102.4 5.12 10.24 $11,308.29 Report of annual equipment inspection Incl. in 6B Semiannual report of emissions/parameter exceedances and periods when emission/parameter data not obtained j 32 2 64 0.8 51.2 2.56 5.12 $5,654.14 **Subtotal for Reporting Requirements (State/locally**
**- owned HMIWI)**  **824 $79,158.02** 

### 23

**7. 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 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 combus ted (co

- fired combustors only) 2 1 2 0 0 0 0 $0 **Subtotal for Reporting Requirements (Co**
**- fired combustors and pathological/low** 
**- level**  **radioactive/chemotherapeutic waste combustors) 0**  **$0**
**8. Recordk**

**eeping requirements (States)** A. Read instructions NA B. Plan activities NA C. I mplement activities NA D. Develop record system NA E. Time to enter information NA F. Time to train personnel NA G. Time for audits NA **Subtotal for Recordk**

**eeping Requirements (States) 0**  0 **9. Recordk**

**eeping requirements (privately**
**- owned HMIWI)**  A. Read instructions N/A B. Plan activities N/A C. I mplement activities N/A D. Develop record system N/A E. Time to enter information Records of startup, shutdown, malfunction 1.5 52 78 47 3,666 183.3 366.6 $404,845.55 Records of persons reviewing operating information r 2 2 4 47 188 9.4 18.8 $20,761.31 Records of operators completing training 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 4E Records of process and control device operating parameters

- Small rural HMIWI 0.5 52 26 2 52 2.6 5.2 $5,742.49

- All other HMIWI 1.5 52 78 45 3,510 175.5 351 $387,618.08 Records of CMS operation and maintenance

### 24

- Small rural HMIWI 0.5 250 125 2 250 12.5 25 $27,608.13

- All other HMIWI 1.5 250 375 45 16,875 843.75 1,688 $1,863,548.44 Records of emissions/parameter exceedances and periods when emission/parameter data not obtained j

- Small rural HMIWI 0.5 52 26 0.4 10.4 0.52 1.04 $1,148.50

- All other HMIWI 1.5 52 78 9 702 35.1 70.2 $77,523.62 Records of annual and subsequent compliance tests See 4E Records of annual equipment inspection See 4B F. Time to train personnel 40 1 40 0 0 0 0 $0 G. Time for audits N/A **Subtotal for Recordk**

**eeping Requirements (Privately**
**- owned HMIWI)**  **2 9**  **, 04**  **2 $2,788,796.10**  **10. Recordk**

**eeping requirements (Federally**
**- owned HMIWI)**  A. Read instructions N/A B. Plan activities N/A C. I mplement activities N/A D. Develop record system N/A E. Time to enter information Records of startup, shutdown, malfunction 1.5 52 78 6 468 23.4 46.8 $51,682.41 Records of persons reviewing operating information 2 2 4 6 24 1.2 2.4 $2,650.38 Records of operators completing training 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 5E Records of process and control device operating parameters 1.5 52 78 6 468 23.4 46.8 $51,682.41 Records of CMS operation and maintenance 1.5 250 375 6 2,250 112.5 225 $248,473.13 Records of emissions/parameter exceedances and periods when emission/parameter data not obtained j 1.5 52 78 1.2 93.6 4.68 9.36 $10,336.48 Records of annual and subsequent compliance tests See 5E Records of annual equipment inspection See 5B F. Time to train personnel 40 1 40 0 0 0 0 $ 0 G. Time for audits N/A **Subtotal for Recordk**

**eeping Requirements (Federally**
**- owned HMIWI)**  **3,799 $364,824.81**  **11. Recordk**

**eeping requirements (State/locally**
**- owned HMIWI)**  A. Read instructions N/A B. Plan activities N/A C. I mplement activities N/A D. Develop record system N/A

### 25

E. Time to enter information Records of startup, shutdown, malfunction 1.5 52 78 4 312 15.6 31.2 $34,454.94 Records of persons reviewing operating information r 2 2 4 4 16 0.8 1.6 $1,766.92 Records of operators completing training 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 5E Records of process and control device operating parameters 1.5 52 78 4 312 15.6 31.2 $34,454.94 Records of CMS operation and maintenance 1.5 250 375 4 1,500 75 150 $165,648.75 Records of emissions/parameter exceedances and periods when emission/parameter data not obtained j 1.5 52 78 0.8 62.4 3.12 6.24 $6,890.99 Records of annual and subsequent compliance tests See 5E Records of annual equipment inspection See 5B F. Time to train personnel 40 1 40 0 0 0 0 $0 G. Time for audits N/A **Subtotal for Recordk**

**eeping Requirements (State/Locally**
**- owned HMIWI)**  **2,53 3**  **$243,216.54 12. Recordk** 

**eeping requirements (co**
**- fired and pathological/low** 
**- level radioactive/**  **chemotherapeutic combustors)** A. Read instructions N/A B. Plan activities N/A C. I mplement 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 k 2 4 8 13.4 107.2 5.36 10.72 $11,838.36 Quarterly records of weight of hospital waste and medical/infectious waste combusted, and weight of all other fuels and waste combusted (co

- fired only) k 2 4 8 5 40 2 4 $4,417.30
**Subtotal for Recordk**

**eeping Requirements (Co** 
**- fired and pathological/low level radioactive /**  **chemotherapeutic combustors) 169**  **$16,255.66** F. Time to train personnel N/A G. Time for audits N/A **TOTAL REPORTING REQUIREMENTS (**  **FROM SUBTOTALS )**  **24,53 7**  **$2,333,255 TOTAL RECORDKEEPING**  **REQUIREMENTS ( FROM SUBTOTALS**  **) 35,**  **54 3**  **$3, 413**  **, 093** 
**TOTAL LABOR BURDEN AND COST (ROUNDED)**  **60,0 80**  **$5,7 46**  **, 349** 

### 26

Note: States and tribes may choose to impose requirements that are more stringent. How ever, the burden estimates provided in this ICR assume that the state and tribal plans mirror the federal Emission Guidelines.
**Assu mptions:**  a We have assumed that there are approximately 79 respondents, with no additional new or reconstructed sources becoming subject to the rule over the next three years. The breakdown is as follows: 47 privately

- owned HMIWI (including 2 sm all rural HMIWI ), 6 Federally

- owned HMIWI, and 4 State/locally

- owned HMIWI , and 22 States that require annual State Plan Inventory. b This ICR uses the following labor rates for industry : $ 120.77 per hour for Executive, Administrative, and Managerial labor; $ 99.39 per hour for Technical labor, and $ 50.04 per hour for Clerical labor. These rates are from the United States Department of Labor, Bureau of Labor Statistics, December 2011 “T able 2. Civilian Workers, by Occupational and Industry group.” The rates are from column 1, “Total Compensation.” The rates have been increa sed by 110 percent to account for the benefit packages availab le to those employed by private industry. In addition, this ICR uses the following labor rates for State government: $66.98 for Managerial labor; $52.13 for Technical labor, and $24.35 for Clerical labor. These rates are from the United States Department of Labor, Bureau of Labor Statistics, May 2011 National Industry

- Specifics Occupational Employment and Wage Estimates for State government (NAICS code 999200). The rates have been increased by 60 percent to account for the benefit packages available to State government employees. c Assume all 22 states with HMIWI have approved State Plan by the first year of this ICR. How ever, the State Plan/Inventory is updated on an annual basis. d We have assumed that it will take 40 hours for each new respondent to read requirements. e The zero value for number of respondents indicates that burden was incurred prior to the time period covered by this supporti ng statement or for new respondents. f We have assumed that it would take each respondent 20 hours each to u pdate the annual operating information. g We have assumed that it would take each respondent 8 hours to review the operating information with each operator. h We have assumed that each facility will take 160 hours to develop the operating information. i We have assumed that each facility will rake 40 hours to develop the waste management plan. j Assume 20 percent of respondents report exceedances, and 80 percent report no exceedances

. k We have assumed that all co - fired and pathological/low

- level radio active/ chemotherapeutic combustors units would be owned by the private sector.

### 27

**Table 2: Average Annual EPA Burden and Cost**

**– State and Federal Emission Guidelines for Hospital/Medical/Infectious**  **Waste Incinerators (40 CFR Part 60, Subpart Ce and 40 CFR Pa**  **rt 62, Subpart HHH) (Renewal)**

**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. I nitial 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 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

- Small rural HMIWI 2 1 2 2 4 0.2 0.4 $207.30

- All other HMIWI 6 1 6 55 330 16.5 33 $17,102.09

### 28

Emissions/parameter exceedances and periods when emission/parameter data not obtained c

- Small rural HMIWI 4 1 4 0.4 1.6 0.08 0.16 $82.92

- All other HMIWI 16 1 16 11 176 8.8 17.6 $9,121.11 Results of annual performance test

- Small rural HMIWI 6 1 6 2 12 0.6 1.2 $621.89

- All other HMIWI 24 1 24 55 1,320 66 132 $68,408.34 Report of no exceedances

- Small rural HMIWI 2 1 2 1.6 3.2 0.16 0.32 $165.84

- All other HMIWI 8 1 8 44 352 17.6 35.2 $18,242.22 Review semiannual report of emissions/ parameter exceedances and periods when emission/parameter data not obtained c

- Small rural HMIWI 2 1 2 0.4 0.8 0.04 0.08 $41.46

- All other HMIWI 8 1 8 11 88 4.4 8.8 $4,560.56 Report of annual equipment inspection (Small rural HMI WI ) 4 1 4 2 8 0.4 0.8 $414.60 Report of annual control equipment inspection (All other HMIWI) 4 1 4 0 0 0 0 $0 G. Review reports for States Review annual update of State Plan Inventory d 8 1 8 22 176 8.8 17.6 $9,121.11 4. Prepare annual summary report e 1 1 1 57 57 2.9 5.7 $2,954.00 **TOTAL ANNUAL BURDEN AND COST 2,908**  **$131,043.43**
**Assu mptions:**  a We have assumed that there are approximately 57 respondents, with no additional new or reconstructed sources becoming subject to the rule over the next three years. The 57 respondents are located in 22 States. b This cost is based on the following hourly labor rates times a 1.6 benefits multiplicat ion factor to account for government overhead expenses: $ 62.27 for Managerial (GS

- 13, Step 5, $ 38.92 x 1.6), $ 46.21 for Technical (GS

- 12, Step 1, $ 28.88 x 1.6) and $ 25.01 Clerical (GS

- 6, Step 3, $ 15.63 x 1.6). These rates are from the Office of Personnel Management (OPM) “20 11 General Schedule” which excludes locality rates of pay. c Assume 20 percent of respondents report parameter exceedances , and 80 percent report no exceedances

. d Assume all 22 States have approved State/Plan Inventory by the first y ear of this ICR. All States are expected to update State Plan/Inventory annually.
e We have assumed that all respondents will have to prepare annual summary report.