### SUPPORTING STATEMENT **ENVIRONMENTAL PROTECTION AGENCY NSPS for Hospital/Medical/Infectious Waste Incinerators (40 CFR Part 60, Subpart Ec)**  **(Renewal)**
**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) , EPA I CR Number 1730.09 , OMB Control Number 2060

- 0363 **1(b) Short Characterization/Abstract** The New Sour ce Performance Standards (NSPS) for Hospital/Medical/ Infectious Waste In cinerators (HMIWI) were promulgated on September 15, 1997, and amended on October 6, 2009

. The original standards applied to owners or operators of HMIWIfor which construction commenced after June 20, 1996, or for which modification commenced after March 16, 1998 , but no later than April 6, 2010. Sources subject to the original standards are now covered under the revised Emission Guidelines for HMIWI at 40 CFR part 60, subpart Ce. This information request covers the reporting and re cordkeeping requirements associated with the revised NSPS, which appl y to new facilities only. N ew facilities include those that commenced construction after December 1, 2008 or commenced modification after April 6, 2010 . This information is being collected to assure compliance with 40 CFR part 60, subpart Ec

. In general, all NSPS standards require initial notifications, performance tests, and periodic reports by

the owners/operators of the affected facilities. They ar e 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 s ys tem is inoperative. These notifications, reports, and records are essential in determining compliance, and are required of all affected facilities subject to NSPS

. Any owner/operator subject to the provisions of this part shall maintain a file of these measurements, and retain the file for at least five years following the date of such measurements, maintenance reports, and records. All reports are sent to the delegated state or local authority

. In the event that there is no such delegated authority , the r eports are sent directl y to the U. S. Environme ntal Protection Agency (EPA) regional office. Based on our consultations with industry representatives, there is an average of one affected facility at each plant site and that each plant site has only one respondent (i.e., the owner/operator of the plant site).
Over the next three ye ars, an average of five respondents per ye ar will be subject to the standard s , and one additional respondent per year will become subject to the standard s
. The Office of Management and Budget (OMB) approved the current ICR without any

### 2

“Terms of Clearance”.
The “Affected Public” is owners and operators of HMIWIsubject to the revised NSPS

. The burden to the “Affected Public” may be found below in Table 1: Annual Respondent Burden and Cost

– NSPS for Hospital/Medical/ Infectious Waste Incinerators (40 CFR Part 60, Subpart Ec) (Renewal) . The burden to the “Federal Government” is attributed entirely to work performed b y federal employees or government contractors; this burden is found below in Table 2: Average Annual EPA Burden and Cost

– NSPS for Hospital/Medical/ Infectious Waste Incinerators (40 CFR Part 60, Subpart Ec) (Renewal)

. **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 sy stem of continuous emissions reduction which (taking into consideration the cost of achieving such emissions reduction, or an y non - air quality health and environmental impact and energy requirements) the Administrat or determines has been adequatel y 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 e very four years. In addition, section 114(a) states that the Administrator may require any

owner/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 informat ion as the Admini strator may reasonabl y require.

### 3

In the Administrator's judgment, dioxin/furan, particulate matter (PM), carbon monoxide (CO), h ydrogen chloride (HCl), sulfur dioxide (SO 2 

### ), nitrogen oxides (NO x

### ), lead (Pb), cadmium (Cd), and mercury (Hg) emissions from HMIWI either cause or contribute to air pollution that may reasonably

be anticipated to endanger either public health or welfare. Therefore, the NSPS were promulgated for this source category at 40 CFR part 60, subpart Ec

. **2(b) Pract ical 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 f or 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. 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 c heck if the pollution control devices are properl y installed and operated and leaks are being detected and repaired and the standard are being met. The performance test may also be observed. The required semiannual reports are used to determine periods o f excess emissions, identify problems at the facility , verify operation/maintenance 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 Ec

. **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 adopted 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 exist. **3(b) Pub lic 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 ( 77 FR 47631 ) on August 9, 2012 . No comments were received on the

### 4

burden published in the Fede ral 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 years. 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 needed for compliance purposes. In developing this I CR, we co ntacted : 1) St. Joseph’s Hospital , at (813) 870

- 4000 ; and 2) the Wilkes

- Barre General Hospital , at ( 570) 829

- 8111

. 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 collect ion 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 emiss ion limitations are met. I f 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** 
T hese reporting or recordkeeping requirements do not violate any of the regulations promulgated b y 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 years. 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. The 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 appropriat e level of enforcement action. EPA has found that the most flagr ant violators have violations extending beyond five ye ars. In addition, EPA would be prevented from pursuing the violators due to the destruction or the non - existence of essential records.

### 5

**3(f) Confidentiality** Any information submitted to the Agency f or 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 4 3 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 Inform ation Requested**  **4(a) Respondents/SIC Codes** The respondents to the recordkeeping and reporting requirements are owners and operators of HMIWI

. The United States Standard Industrial Classification (SI C) codes for the respondents affected b y the standards, which corresponds to the North American Industry Classification System (NAI CS) codes, are listed below for this source category

. **Standard ( 40 CFR**  **P art**  **60, S**  **ubpart Ec**  **) SIC Codes**  **NAICS Codes** General Medical and Surgical Hospitals 8062 622110 Specialty Hospitals 8069 622310 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 Physical, Chemical, and L ife Sciences 8731, 8733 541710 National Security 9711 928110 Public Health Facility 9431 923120 **4(b) Information Requested (i) Data Items** 
In this ICR , all the data that is recorded or reported is required b y NSPS for Hospital/ Medical/ Infectious Waste Incinerators (40 CFR Part 60, Subpart Ec)

. A source must make the following reports:

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**Notification s**  Notification and application of construction or modification 60.58c(a) , 60.7(a) Notification of anticipated startup 60.58c(a) , 60.7(a) Notification of actual startup 60.7(a) Notification of ty

pe(s) of waste to be combusted 60.58c(a) (2)(i) Notification of HMIWIcapacit y 60.58c(a) (2)(ii) Notification of initial continuous monitoring sy stem (CMS) demonstration (including CO CEMS) 60.7(a) Notification of initial performance test 60.8(d) Notification of exemption claim for combustors burning pathological, low

- level radioactive, and/or chemotherapeutic waste 60.50c(b)(1) Notification of exemption claim for co

- fired combustors 60.50c(c)(1) **Reports** Statement of intent to construct/modify 60.58c(a)(1)(i) Documentation produced as a result of the siting requirements 60.58c(a) (1)(iv) , 60.54c(c) W aste management plan 60.58c( c ) (3) , 60.55c Analy sis and supporting documentation demonstrating conformance with EPA guidance and specifications for bag leak detection sy stems 60.58c(c) (4) Report of initial performance tests 60.58c(d) (6) , 60.8(a) Initial report of values for site

- specific operating parameters 60.58c(c) (2) , 60.7(a) Annual r eport of values for site

- specific operating parameters 60.58c(d) (1) Annual and semiannual report s of emissions or operating parameter exceedances , malfunctions, and periods for which data on emissions/operating parameters were not obtained 60.58c(d) , 60.58c(e) , 60.7(c) Annual report of no excess emi ssions 60.58c(d) (7) , 60.7(c) Report of results of annual performance test 60.58c(d) (6) Annual report of control equipment inspection 60.58c(d) A source must keep the following records: **Recordkeeping** Retention of records for 5 ye ar s 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 operators completing revie w of HMIWIoperating manual 60.58c(b) (8) Records of operators completing operator training course and qualification requirements 60.58c(b) (9)

- (10)
Records of initial and annual testing of fugitive ash emissions 60.58c(b) (2)(ii)

### 7 **Recordkeeping** Records of process and control device operating parameters 60.58c(b) (2)(iii) (xix) Records of CMS operation and maintenance (including CO CEMS) 60.7(f) Records of emissions or operating parameter exceedances , malfunctions, and periods fo r which data on emissions/operating parameters were not obtained 60.58c(b) (3)

- (5)

Records of initial, annual, and an y subsequent performance tests 60.58c(b) (6) Records of calibration of monitoring devices (including CO CEMS) 60.58c(b) (11) Records of annual control equipment inspections, required maintenance, and repairs not completed during established timeframe 60.58c(b) (2)(xvii) Records of bag leak detection sy stem alarms and corrective action taken 60.58c(b) (2)(xviii)
Records of CO concentrations from CO CEMS 60.58c(b) (2)(xix) Records on quarterl y basis of ty pes and amounts of materials charged for co

- fired combustors and for incinerators burning onl y pathological, low

- level radioactive, and/or chemotherapeutical waste 60.50c (b) , (c)

Electronic Reporting
Some of the r espondents 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 sy stems to transmit data electronically . However, electronic reporting s ys tems are still not widely used. At this time, it is estimated that approximately 10 percent of the respon dents use electronic reporting.

**(ii) Respondent Activities**

**Respondent Activities** Read instructions. Perform CMS demonstrations and repeat CMS demonstrations if necessary. Perform performance tests and repeat performance tests if necessary

. Develop, update, and review operating information. Perform control equipment inspections. Prepare and submit the notifications and reports listed in the table above. Develop waste management plan. Prepare and review reports of performance tests. Prepare and review reports of CMS demonstrations. Document siting requirements.

### 8 **Respondent Activities** Complete operator training and qu alification

. Maintain the records listed in the table above. Train personnel. Currently sources are using monitoring and reporting equipment that provide parameter data in an automated way e.g., continuous parameter monitoring s ys tem. A lthough 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 Information 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

. Observe enforcement activities (retesting) related to excess emissions. Review notifications and reports, including performance test reports, and excess emissions reports, required to be submitted by indus try

. 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. Performance test reports are used b y the Agency to discern a source ’ s initial capability to compl y with the emission standard

. Data and records maintained by the respo ndents 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.
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. EP A uses the OTI S for tracking air pollution compliance and enforcement b y local and state regulatory agenci es, EPA regional offices and EPA headquarters. EPA and its delegated Authorities can edit, store, retrieve and analyze the data.

### 9

The records requir ed b y this regulation must be retained by the owner/operator for five ye ars. **5(c) Small Entity Flexibility** There are no small entities (i.e., small businesses) affected b y this regulation

. 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 employed, the recordke eping 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. However, the regulation includes various provisions that would reduce the burden on HMIWI , including small entities. For example, there are provisions allowing HMIWI to skip annual tests and test reports for the two

- ye ar periods if they have demonstrated compliance for three annual tests in a row

. **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

– NSPS for Hospital/Medical/ In fectious Waste Incinerators (40 CFR Part 60, Subpart Ec) (Renewal)

. **6. Estimating the Burden and Cost of the Collection** Table 1 documents the computation of individual burdens for the recordkeeping and reporting requirements applicable to the industry for the subpart included in this IC R. 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 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 display s a currently valid OMB Control Number. **6(a) Estimating Respondent Burden**
T he average annual burden to industry over the next three years from these recordkeeping and reporting requirement s is estimated to be 3, 912 ( 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 the NSPS program, the previously approved ICR, and an y comments received.

**6(b) Estimating Respondent Costs**

### 10
**(i) Estimating Labor Costs** This I CR uses the following labor rates: Managerial $1 21

. 4 4 ($5 7

. 8 3 + 110%) Technical $ 100

. 23 ($4 7

. 73 + 110%) Clerical $ 50

. 5 1 ($2 4

. 05 + 110%) These rates are from the United States Department of Labor, Bureau of Labor Statistics, March 2012 , “ 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 employed by private industry

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

costs associated with the information collection activities in the subject standard are both labor costs which are addressed elsewhere in this ICR and the costs associated with continuous monitoring. The capital/startu p 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**  **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) DIFF/WS $1,233 1 $1,233 $4,733 5 $23,665 DIFF $967 1 $967 $2,733 5 $13,665 WS $1,233 1 $1,233 $1,133 5 $5,665 SNCR $1,400 1 $1,400 $300 5 $1,500 CO CEMS $17,500 1 $17,500 $25,100 5 $125,500 BLD $1,033 1 $1,033 $1,267 5 $6,335 ACI $0 1 $0 $3,367 5 $16,835 Testing $67,458 1 $67,458 $0 5 $0 Filing Cabinets $100 1 $ 100 $0 5 $0 Photocopying $0 1 $0 $199 5 $995 Postage $0 1 $0 $93 5 $465 **TOTAL** $ 90,924 1 **$90,924** $ 38.925 5 **$ 194,625**  Note: The capital and O&M costs per respondent represents the average cost of large , medium , and small units. 

### The total capital/startup costs for this I CR are $ 90,924

. This is the total o f column D in the above table.

### 11

The total operation and maintenance (O&M) costs for this I CR are $ 194,625

. 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 ye ars of the I CR is estimated to be $ 285,549

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

are those costs associated with anal ys is 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 the three years of the ICR is estimated to be $ 16,717

. This cost is based on the average hourl y labor rate as follows: Managerial $ 6 2.27 (GS

- 13, Step 5, $ 3 8. 92 + 60% ) Technical $ 4 6

. 21 (GS

- 12, Step 1, $ 28. 88 + 60% ) Clerical $2 5.01 (GS

- 6, Step 3, $ 15. 63 + 60% )
These rates are from the Office of Personnel Management (OPM) , 20 1 2 General Schedule , which excludes locality , rates of pay

. The rates have been increased b y 60 percent to account for the benefit packages available to government employees
. Details upon which this estimate is based appear below in Table 2: Average Annual EPA Burden and Cost

– NSPS for Hospital/Medical/ Infectious Waste Incinerators (40 CFR Part 60, Subpart Ec) (Renewal)

. **6(d) Estimating the Respondent Universe and Total Bur den and Costs**  Based on our research for this I CR, on average over the next three ye ars, approximately f ive existing respondents will be subject to the standard s . It is estimated that , after the initial ye ar of each three

- ye ar cycle, one additional respon dent per ye ar will become subject to these same standards . The overall average number of respondents, as shown in the table below , is five per year. The number of respondents is calculated using the following table that addresses the three ye ars covered b y this ICR.

### 12 **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 1 3 0 0 4 2 1 4 0 0 5 3 1 5 0 0 6 Average 1 4 0 0 5 1 New respondents 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 perio d of this ICR is five

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

### 13 **Total Annual Responses** 

(A) Information Collection Activity (B) Number of respondents (C)

Number of responses (D)

Number of respondents that keep records but do not submit reports (E) Total annual responses E = (B x C) + D Notification of intent to construct 1 1 N/A 1 Notification of anticipated commencement of construction 1 1 N/A 1 Notification of anticipated startup 1 1 N/A 1 Notification of actual startup 1 1 N/A 1 Notification of type(s) of waste to be combusted 1 1 N/A 1 Notification of HMIWI capacity 1 1 N/A 1 Notification of initial performance test 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 management plan 1 1 N/A 1 Analysis and supporting documentation demonstrating conformance with EPA guidance and specifications for bag leak detection systems 0.7 1 N/A 0.7 Report of initial performance test 1 1 N/A 1 Report of initial CMS demonstration 1 1 N/A 1 Annual report CMS emissions and operating parameters 5 1 N/A 5 Exceedances, malfunctions, and periods for which data not obtained 1 1 N/A 1 Results of performance tests conducted during the year 5 1 N/A 5 Report of no exceedances 4 1 N/A 4 Report of annual control equipment inspection 5 1 N/A 5 Semiannual report of exceedances, malfunctions, and periods for which data not obtained 1 1 N/A 1
Total 3 3 .7 

### The number of Total Annu al Responses is 3 4

. The total annual labor costs are $ 378 , 826

. Details regarding these estimates may be found below in Table 1: Annual Respondent Burden and Cost

– NSPS for Hospital/Medical/ In fectious Waste Incinerators (40 CFR Part 60, Subpart Ec) (Renewal)

. **6(e) Bottom Line Burden Hours and Cost Tables** The detailed bottom line burden hours and cost calculations for the respon dents and the

### 14

Agency are shown in Tables 1 and 2 below , respectively , and summarized below. **(i) Respondent Tally** The total annual labor hours are 3, 912 at a cost of $378,826

. Details regarding these estimates may

be found below in Table 1: Annual Respondent Burden and Cost

– NSPS for Hospital/Medical/Infectious Waste Incinerators (40 CFR Part 60, Subpart Ec) (Renewal)

. Furthermore, both the annual public reporting and recordkeeping burden s for this collection of information is estimated to avera ge 11 5 hours per response

. The total annual capital/startup and O&M costs to the regulated entity are $ 285 ,5 49

. The cost calculations are detailed in Section 6(b)(iii), Capital/Startup vs. Operation and Maintenance (O&M) Costs. **(ii) The Agency Tally** The aver age annual Agency burden and cost over next three years is estimated to be 371 labor hours at a cost of $ 16,717 . See below Table 2: Average Annual EPA Burden and Cost

– NSPS for Hospital/Medical/ Infectious Waste Incinerators (40 CFR Part 60, Subpart Ec) (Renewal)

. **6(f) Reasons for Change in Burden** There is an adjustment increase in the total estimated burden as currentl y identified in the OMB Inventory

of Approved Burdens ; however, this increase is not due to an y program changes. Instead, the change in the burden and cost estimates occurred because the revised standard has been in effect for more than three ye ars and the requirements are different during initial compliance for new facilities as compared to on

- going compliance for existing facilities. The previous ICR reflected those burdens and costs associated with the initial activities for subject facilities. This includes purchasing monitoring equipment, conducting performance tests and establishing recordkeeping sy stems. This ICR re flects the on

- going burden and costs for existing facilities. Activities for existing source include both the continuously monitoring of pollutants and the submission of semiannual reports. In addition, there are a number of new facilities that are accounted in the initial compliance phase , as described above. The overall result is an increase in : burden hours , labor costs , and O&M costs

. Furthermore, a portion of the labor cost increase is a result of increased labor rates. This I CR uses updated labor rates from the Bureau of Labor Statistics in order to calculate burden costs. Additionally , there is an adjustment decrease in capital costs in this I CR compared to the previous I CR. This is not due to any program changes. The previous I CR assumed all capital costs associated with monitoring were incurred during a single ye ar. By contrast, this I CR calculates the average capital costs for new sources for each year covered under the ICR.

### 15

**6(g) Burden Statement** The annual public reporting and recordkeeping burden s for this collection of information is estimated to ave rage 11 5 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; dev elop, acquire, install, and utilize technology and sy stems 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 an y 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 agenc y m ay

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 this I CR under Docket ID Number EPA

- HQ

- OECA

- 2012

- 0502 . 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 also availa ble 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

- 1 752

. 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

- 2012

- 0502 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.

### 16

**Table 1: Annual Respondent Burden and Cost** 

**– NSPS for Hospital/Medical/ Infectious Wast**  **e Incinerators (40 CFR Part 60, Subpart Ec) (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)** 

**Managem ent**  **person hours per year**  **(Ex0.05) (G)** 

**Clerical person**  **hours per**  **year (Ex0.1)**  **(H)**

**Total Cost Per year**  **b**

1. Applications N/A 2. Survey and Studies N/A 3. Reporting requirements A. Read instructions 1 1 1 1 1 0.05 0.1 $111.35 B. Required activities Perf ormance spec tests ( certif. ) for CMS c 16 1 16 1 16 0.8 1.6 $1,781.65 Repeat perf

ormance spec tests ( certif. ) for CMS c, d 16 1 16 0 0 0 0 $0 Development of operating information e 160 1 160 1 160 8 16 $17,816.48 Annual update of operating information f 20 1 20 5 100 5 10 $ 11,135.30 Review of operating information with each operator g, h 8 2 16 5 80 4 8 $8,908.24 Initial control equipment inspection i 20 1 20 1 20 1 2 $2,227.06 Annual control equipment inspection i 20 1 20 5 100 5 10 $11,135.30 C. Create information See 3B D. Gather existing information See 3B E. Write reports Notification of intent to construct 2 1 2 1 2 0.1 0.2 $222.71 Notification of anticipated commencement of construction g 2 1 2 1 2 0.1 0.2 $222.71

### 17

**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)** 

**Managem ent**  **person hours per year**  **(Ex0.05) (G)** 

**Clerical person**  **hours per**  **year (Ex0.1)**  **(H)**

**Total Cost Per year**  **b**

Notification of anticipated startup g 2 1 2 1 2 0.1 0.2 $222.71 Notification of actual startup g 2 1 2 1 2 0.1 0.2 $222.71 Noti fi cation of type(s) of waste to be combusted 2 1 2 1 2 0.1 0.2 $222.71 Notification of HMIWI capacity 2 1 2 1 2 0.1 0.2 $222.71 Notification of initial performance test h 2 1 2 1 2 0.1 0.2 $222.71 Notification of initial CMS demonstration 2 1 2 1 2 0.1 0.2 $222.71 Initial report for the site selection analysis j 460 1 460 1 460 23 46 $51,222.38 Waste management plan k 160 1 160 1 160 8 16 $17,816.48 Analysis and supporting documentation demonstrating conformance with EPA guidance and specifications for bag leak detection systems l 40 1 40 0.7 28 1.4 2.8 $3,117.88
Report of initial performance test m 8 1 8 1 8 0.4 0.8 $890.82 Report of initial CMS demonstration m See 3B Annual report CMS emissions/operation parameters n 32 1 32 5 160 8 16 $17,816.48 Exceedances/ malfunctions/periods of which data not obtained o , p 48 1 48 1 48 2.4 4.8 $5,344.94 Results of performance tests con ducted during the year q 40 1 40 5 200 10 20 $22,270.60 Report of no exceedances o , p 24 1 24 4 96 4.8 9.6 $10,689.89 Report of annual control equipment inspection See 3B

### 18

**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)** 

**Managem ent**  **person hours per year**  **(Ex0.05) (G)** 

**Clerical person**  **hours per**  **year (Ex0.1)**  **(H)**

**Total Cost Per year**  **b**

Semiannual report of exceedances/ malfunctions/periods for which data not obtained q, p, r 48 1 48 1 48 2.4 4.8 $5,344.94 **Subtotal for Reporting Requirements 1,956**  **.15 $18**  **9 ,**  **411 .47**  4. 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 Documentation produced as a result of sitting requirements See 3E Records of operators completing operator training requirements h 2 2 4 1 4 0.2 0.4 $445.41 Records of operators that have been qualified as HMIWI operators h 2 2 4 1 4 0.2 0.4 $445.41 Records of initial performance test See 3E Records of startup, shutdow n, or malfunction 1.5 52 78 5 390 19.5 39 $43,427.67 Records of persons completing review of operating information h 2 2 4 5 20 1 2 $2,227.06 Records of process and control device operating parameters 1.5 52 78 5 390 19.5 39 $43,427.67 Records of CMS operation and maintenance s 0. 0 3 365 9.1 3 5 45.63 2.28 4.56 $5,080.48

### 19

**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)** 

**Managem ent**  **person hours per year**  **(Ex0.05) (G)** 

**Clerical person**  **hours per**  **year (Ex0.1)**  **(H)**

**Total Cost Per year**  **b**

Records of exceedances/malfunctions/periods for which data not obtained 1.5 52 78 5 390 19.5 39 $43,427.67 Records of annual and any subsequent com pliance tests See 3E Records of annual control equipment inspections See 3B Records of bag leak detection system alarms l 1.5 52 78 3 .3 257.4 12.9 25.7 $28,662.26 F. Time to train personnel t 40 1 40 5 200 10 20 $22,270.60 F. Time for audits N/A **Subtotal for Recordkeeping Requirements 1,956**  **.17 $189,414**  **.23 TOTAL LABOR BURDEN AND COST**  **(rounded) 3,912**  **$378,826**
**Assu mptions:** 
a We have assumed that the average num ber of sources that will be subject to the standard will be 5. There will be one additional new source per year that will become subject to the rule over the three

- year period o f this ICR b This ICR uses the following labor rates: $121.44 per hour for Executive, Administrative, and Managerial labor; $100.23 per h our for Technical labor, and $50.51 per hour for Clerical labor. These rates are from the United States Department of Labor, Bureau of Labor Statistics, March 2012 ” Ta ble 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 empl oyed by private industry.
c We assume that p erformance specification to certify CMS is expected to take approximately 16 hours. d We a ssume no failures of the initial CMS demonstrations; includes CO CEMS.
e We a ssume it will take 160 hrs to develop the operating information. f We a ssume that it will take 20 hours to update the operating information each year. g We a ssume that it will take 8 hours to review the operating information with each operator. h We a ssume that it will take 2 operators per facility to enter information . Also assume there is no operator turnover at the affected facilities. i We assume that annual co ntrol equipment inspection will occur for all sources. j We a ssume that it will take 460 hours to develop the site selection analysis. k We a ssume that it will take 160 hours to develop the waste management plan. l We a ssume that it will take 40 hours to develop the bag leak detection system analysis and 1.5 hours to record bag leak detection system alarms. Assume the

### 20

total number of source s will be evenly distributed among small, medium, and large sources and only new large and medium sources (i.e. two

- thirds of the effected sources) will install baghouses.
m We a ssume that it will take 8 hours for each facility to review th e report of the initial performance test for pollutants and fugitive ash.
n Person

- hours per occurrence are assumed to be 32 hours.
o We have assume that it will take 48 hours and 24 hours per report per affected facility to report monitoring exceedances and no excess emissions, respectively. Because testing and monitoring requirements focus primarily on three pollutants (PM, CO, and HCl), assume three pollutants. p Assume 20 percent of respondents report monitoring exceedances and 80 percent report no exc ess emissions. q Assume 40 hours to revie w report of annual compliance test.
r Because the semiannual report coincides once each year with the annual report and both reports include information on exceedances, malfunctions, and periods for which data were not obtained, the frequency of the semiannual report is shown in the table as only once per year to avoid double

- counting.
s We assume that this activity will be recorded daily. t We assumed that it will take 40 hours once per year to train one person to p erform the Method 9 and Method 22 tests. The labor requirements to train the personnel were estimated to be 8 hr/d for 5 d/yr.

### 21

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

**– NSPS for Hospital/Medical/ Infectious Waste Incinerators (40 CFR**  **Pa rt 60,**  **Subpart Ec) (Renewal)**

**Activity (A)**  **EPA 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)** 

**Managem ent**  **person hours per year**  **(Ex0.05) (G)** 

**Clerical person**  **hours per year**  **(Ex0.1) (H)** 

**Total Cost**  **Per year b** 

1. Attend initial performance test c 32 1 32 0.08 2.56 0.13 0.26 $132.67 2. Repeat performance test A. Retesting preparation d 12 1 12 1 12 0.6 1.2 $621.89 B. Attend retesting e 32 1 32 0.1 3.2 0.16 0.32 $165.84 3. Litigation f NA 4. Excess emissions

– enforcement activities g 32 1 32 0.1 3.2 0.16 0.32 $165.84 5. Report review Review notification of intent to construct 2 1 2 1 2 0.1 0.2 $104 .00 Review notification of anticipated commencement of construction 2 1 2 1 2 0.1 0.2 $104 .00 Review notification of anticipated startup 2 1 2 1 2 0.1 0.2 $104 .00 Review notification of actual startup 2 1 2 1 2 0.1 0.2 $104 .00 Review notification of types of waste to be combusted 2 1 2 1 2 0.1 0.2 $104 .00 Review notification of HMIWI capacity 2 1 2 1 2 0.1 0.2 $104 .00 Review notification of initial performance test 2 1 2 1 2 0.1 0.2 $103.65 Review notification of initial CMS demonstration 2 1 2 2 2 0.1 0.2 $103.65 Review notification addressing sitting requirements 24 1 24 1 24 1.2 2.4 $1,243.79 Review w aste management plan 8 1 8 1 8 0.4 0.8 $414.60

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**Activity (A)**  **EPA 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)** 

**Managem ent**  **person hours per year**  **(Ex0.05) (G)** 

**Clerical person**  **hours per year**  **(Ex0.1) (H)** 

**Total Cost**  **Per year b** 

Review analysis for bag leak detection systems h 8 1 8 0.7 5.6 0.28 0.56 $290.22 Review report of initial performance test i 54 1 54 1 54 2.7 5.4 $2,798.52 Review report of initial CMS demonstration N/A Review annual report CMS emissions/operating parameters j 6 1 6 5 30 1.5 3 $1,554.74 Exceedances/malfunctions/periods for which data not obtained l 8 1 8 1 8 0.4 0.8 $414.60 Results of performance test conducted during the year l PM, CO, HCl 18 1 18 5 90 4.5 9 $4,664.21 Fugitive ash emissions 6 1 6 5 30 1.5 3 $1,554.74 Report of no exceedances m 2 1 2 4 8 0.4 0.8 $414.60 Report of annual control equipment inspection n 4 1 4 5 20 1 2 $1,036.49 Review semiannual report of exceedances/ malfunctions/periods for which data not obtained k, o 8 1 8 1 8 0.4 0.8 $414.60
**TOTAL ANNUAL BURDEN AND COST**  **(rounded) 371**  **$ 16**  **, 717** 

a We have assumed that the average number of sources that will be subject to the standard will be 5. There will be one additi onal new source per year that will become subject to the rule over the three

- year period of this ICR b This ICR uses the following labor rates: Managerial $62.27 (GS

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

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

- 6, Step 3, $15.63 + 60%). These rates are from the Office of Personnel Management (OPM), 2012 General Schedule, which ex cludes locality rates of pay. The rates have been increased by 60 percent to account for the benefit packages available to government employees.
c We a ssume EPA personnel attend 8 percent of the initial p erformance tests

. d We assume that 20 percent will fail the initial performance test, and will have to repeat the performance test.

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e We a ssume 10 percent of re

- tests are attended by EPA personnel. f This ICR does not account for litigation costs. g We a ssume 10 percent of the affected facilities are required to re

- test as a result of excess emissions, and that EPA personnel attend 10 percent of these tests. h We a ssume only new large and medium sources will install baghouses. I We a ssume 6 person

- hours per report per pollutant. For the three ne w HMIWI, nine pollutants are required to be tested. j We a ssume 1 person

- hour per report per CMS. For HMIWI, assume each uses six CMS (flue gas temperature, secondary chamber temperature, charge wei ght, scrubber liquor pH, scrubber liquor flow , and scrubb er energy input). k We a ssume 20 percent of the affected facilities with recurrent burden will report monitoring exceedances. l We a ssume 6 person

- hours per report per pollutant

. For annual tests, there are three pollutants (PM, CO, and HCl) for all HMIWI.
m We a ssume 8 0 percent of the affected facilities with recurrent burden will report no excess emissions.
n We a ssume it will take 4 hours to review the annual control equipment inspection report.
o Because the semiannual repo rt coincides once each year with the annual report and both reports include information on exceedances, malfunctions, and periods for which data were not obtained, the frequency of semiannual report is shown in the table as only once per year to avoid dou b le

- counting.