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 ICR Number 1730.09, OMB Control Number 2060-0363

1(b) Short Characterization/Abstract

The New Source Performance Standards (NSPS) for Hospital/Medical/ Infectious Waste 

Incinerators (HMIWI) were promulgated on September 15, 1997, and amended on October 6, 

2009. The original standards applied to owners or operators of HMIWI for 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 recordkeeping requirements associated with the revised NSPS, 

which apply to new facilities only. New 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 are also required to 

maintain records of the occurrence and duration of any startup, shutdown, or malfunction 

in the operation of an affected facility, or any period during which the monitoring system is 

inoperative. These notifications, reports, and records are essential in determining compliance, 

and are required of all 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 reports are sent directly to the U. S. 

Environmental 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 years, an average of five respondents per year will be subject to the 

standards, and one additional respondent per year will become subject to the standards.

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

The “Affected Public” is owners and operators of HMIWI subject 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 by 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 system of continuous 

emissions reduction which (taking into consideration the cost of 

achieving such emissions reduction, or any non-air quality health 

and environmental impact and energy requirements) the 

Administrator determines has been adequately demonstrated. 

Section 111(a)(l).

The Agency refers to this charge as selecting the best demonstrated technology (BDT). Section 

111 also requires that the Administrator review and, if appropriate, revise such standards every

four years. 

In addition, section 114(a) states that the Administrator may require any owner/operator 

subject to any requirement of this Act to: 

(A) Establish and maintain such records; (B) make such reports; 

(C) install, use, and maintain such monitoring equipment, and use 

such audit procedures, or methods; (D) sample such emissions (in 

accordance with such procedures or methods, at such locations, at 

such intervals, during such periods, and in such manner as the 

Administrator shall prescribe); (E) keep records on control 

equipment parameters, production variables or other indirect data 

when direct monitoring of emissions is impractical; (F) submit 

compliance certifications in accordance with Section 114(a)(3); 

and (G) provide such other information as the Administrator may

reasonably require. 
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In the Administrator's judgment, dioxin/furan, particulate matter (PM), carbon monoxide 

(CO), hydrogen chloride (HCl), sulfur dioxide (SO2), nitrogen oxides (NOx), 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) Practical Utility/Users of the Data

The recordkeeping and reporting requirements in the standard ensure compliance 

with the applicable regulations which where promulgated in accordance with the Clean Air 

Act. The collected information is also used for targeting inspections and as evidence in legal 

proceedings.

Performance tests are required in order to determine an affected facility’s initial 

capability to comply with the emission standard. Continuous emission monitors are used to 

ensure compliance with the standard at all times.

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 check if the pollution control devices are properly 

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 of 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 directly to the 

appropriate EPA regional office. Otherwise, the information is sent directly to the delegated 

state or local agency. If a state or local agency has adopted its own similar standards to 

implement the Federal standards, a copy of the report submitted to the state or local agency can 

be sent to the Administrator in lieu of the report required by the Federal standards. Therefore, 

duplication does not exist.

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

An announcement of a public comment period for the renewal of this ICR was published 

in the Federal Register (77 FR 47631) on August 9, 2012. No comments were received on the 
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burden published in the Federal Register.

3(c) Consultations

The Agency has consulted industry 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 System (OTIS) which is operated 

and maintained by EPA's Office of Compliance. OTIS 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 parties 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 ICR, we contacted: 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 collection would decrease the margin of assurance that 

facilities are continuing to meet the standards. Requirements for information gathering and 

recordkeeping are useful techniques to ensure that good operation and maintenance practices 

are applied and emission limitations are met. If the information required by these standards 

was collected less frequently, the proper operation and maintenance of control equipment and 

the possibility of detecting violations would be less likely.

3(e) General Guidelines

These reporting or recordkeeping requirements do not violate any of the regulations 

promulgated by OMB under 5 CFR part 1320, section 1320.5.

These standards require the respondents to maintain all records, including reports and 

notifications for at least five years. This is consistent with the General Provisions as applied to 

the standards. EPA believes that the five-year records retention requirement is consistent the 

Part 70 permit program and the five-year statute of limitations on which the permit program is 

based. The retention of records for five years allows EPA to establish the compliance history of 

a source, any pattern of non-compliance and to determine the appropriate level of enforcement 

action. EPA has found that the most flagrant violators have violations extending beyond five 

years. In addition, EPA would be prevented from pursuing the violators due to the destruction 

or the non-existence of essential records.
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3(f) Confidentiality

Any information submitted to the Agency for which a claim of confidentiality is made 

will be safeguarded according to the Agency policies set forth in Title 40, chapter 1, part 2, 

subpart B - Confidentiality of Business Information (CBI) (see 40 CFR 2; 41 FR 36902, 

September 1, 1976; amended by 43 FR 40000, September 8, 1978; 43 FR 42251, September 

20, 1978; 44 FR 17674, March 23, 1979).

3(g) Sensitive Questions

The 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 HMIWI. The United States Standard Industrial Classification (SIC) codes for the 

respondents affected by the standards, which corresponds to the North American Industry

Classification System (NAICS) codes, are listed below for this source category.

Standard (40 CFR Part 60, Subpart 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 Life 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 by NSPS for Hospital/

Medical/ Infectious Waste Incinerators (40 CFR Part 60, Subpart Ec). 

A source must make the following reports:
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Notifications

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 type(s) of waste to be combusted 60.58c(a)(2)(i)

Notification of HMIWI capacity 60.58c(a)(2)(ii)

Notification of initial continuous monitoring system (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)

Waste management plan 60.58c(c)(3), 60.55c

Analysis and supporting documentation demonstrating conformance 

with EPA guidance and specifications for bag leak detection systems

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 report of values for site-specific operating parameters 60.58c(d)(1)

Annual and semiannual reports 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 emissions 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 years 60.58c(b)

Records of startup, shutdown, or malfunction 60.7(b)

Documentation produced as a result of siting requirements 60.58c(b)(7)

Records of operators completing review of HMIWI operating 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)
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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 for which data on emissions/operating 

parameters were not obtained

60.58c(b)(3)-(5)

Records of initial, annual, and any 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 system alarms and corrective action 

taken

60.58c(b)(2)(xviii)

Records of CO concentrations from CO CEMS 60.58c(b)(2)(xix)

Records on quarterly basis of types and amounts of materials charged 

for co-fired combustors and for incinerators burning only 

pathological, low-level radioactive, and/or chemotherapeutical waste

60.50c(b), (c)

Electronic Reporting

Some of the respondents are using monitoring equipment that automatically records 

parameter data. Although personnel at the affected facility must still evaluate the data, internal 

automation has significantly reduced the burden associated with monitoring and recordkeeping at 

a plant site. 

Also, regulatory agencies in cooperation with the respondents continue to create reporting 

systems to transmit data electronically. However, electronic reporting systems are still not 

widely used. At this time, it is estimated that approximately 10 percent of the respondents 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.
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Respondent Activities

Complete operator training and qualification.

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 system. Although personnel 

at the source still need to evaluate the data, this type of monitoring equipment has significantly 

reduced the burden associated with monitoring and recordkeeping. 

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

Information Management

5(a) Agency Activities

EPA conducts the following activities in connection with the acquisition, analysis, 

storage, and distribution of the required information.

Agency Activities

Observe initial performance tests and repeat performance tests if necessary.

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 industry.

Audit facility records.

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

5(b) Collection Methodology and Management

Following notification of startup, the reviewing authority could inspect the source 

to determine whether the pollution control devices are properly installed and operated. 

Performance test reports are used by the Agency to discern a source’s initial capability to comply 

with the emission 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 operation and maintenance, and for compliance 

determinations.

Information contained in the reports is entered into OTIS which is operated and 

maintained by EPA's Office of Compliance. OTIS 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 OTIS for tracking air pollution compliance and 

enforcement by local and state regulatory agencies, EPA regional offices and EPA headquarters. 

EPA and its delegated Authorities can edit, store, retrieve and analyze the data.
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The records required by this regulation must be retained by the owner/operator for five

years.

5(c) Small Entity Flexibility

There are no small entities (i.e., small businesses) affected by 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 types of control equipment employed, the recordkeeping and reporting requirements are 

the same for both small and large entities. The Agency considers these to be the minimum 

requirements needed to ensure compliance and, therefore, cannot reduce them further for small 

entities. 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-year 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/ 

Infectious 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 ICR. The 

individual burdens are expressed under standardized headings believed to be consistent with the 

concept of burden under the Paperwork Reduction Act. Wherever appropriate, specific tasks and 

major assumptions have been identified. Responses to this information collection are mandatory.

The Agency may not conduct or sponsor, and a person is not required to respond to, 

a collection of information unless it displays a currently valid OMB Control Number.

6(a) Estimating Respondent Burden

The average annual burden to industry over the next three years from these recordkeeping 

and reporting requirements is estimated to be 3,912 (Total Labor Hours from Table 1 below). 

These hours are based on Agency studies and background documents from the development of 

the regulation, Agency knowledge and experience with the NSPS program, the previously 

approved ICR, and any comments received.

6(b) Estimating Respondent Costs
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(i) Estimating Labor Costs

This ICR uses the following labor rates: 

Managerial $121.44 ($57.83+ 110%) 

Technical $100.23 ($47.73 + 110%)

Clerical $50.51 ($24.05 + 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 by 110 percent to account for 

the benefit packages available to those employed by private industry.

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

The type of industry costs associated with the information collection activities in the 

subject standard are both labor costs which are addressed elsewhere in this ICR and the costs 

associated with continuous monitoring. The capital/startup costs are one time costs when a 

facility becomes subject to the regulation. The annual operation and maintenance costs are the 

ongoing costs to maintain the 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 ICR are $90,924. This is the total of column D in 

the above table. 
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The total operation and maintenance (O&M) costs for this ICR 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 years of the ICR 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 analysis of the reported 

information. EPA's overall compliance and enforcement program includes activities such as the 

examination of records maintained by the respondents, periodic inspection of sources of 

emissions, and the publication and distribution of collected information. 

The average annual Agency cost during the three years of the ICR is estimated to be 

$16,717. 

This cost is based on the average hourly 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), 2012 General Schedule,

which excludes locality, rates of pay. The rates have been increased by 60 percent to account for 

the benefit packages available to government employees. Details upon which this estimate is 

based appear 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 Burden and Costs

Based on our research for this ICR, on average over the next three years, approximately

five existing respondents will be subject to the standards. It is estimated that, after the initial 

year of each three-year cycle, one additional respondent per year 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 

years covered by this ICR. 
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Number of Respondents

Year

(A)

Number of New 

Respondents 1

(B)

Number of 

Existing 

Respondents

(C)

Number of Existing 

Respondents that keep 

records but do not 

submit reports

(D)

Number of Existing

Respondents That 

Are Also New

Respondents

(E)

Number of 

Respondents

(E=A+B+C-D)

1 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.

Column D is subtracted to avoid double-counting respondents. As shown above, the 

average Number of Respondents over the three year period of this ICR is five.

The total number of annual responses per year is calculated using the following table: 
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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 33.7

The number of Total Annual Responses is 34. 

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/ 

Infectious 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 respondents and the 
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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 burdens for this 

collection of information is estimated to average 115 hours per response.

The total annual capital/startup and O&M costs to the regulated entity are $285,549. The 

cost calculations 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 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 currently identified in 

the OMB Inventory of Approved Burdens; however, this increase is not due to any program 

changes. Instead, the change in the burden and cost estimates occurred because the revised 

standard has been in effect for more than three years 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 systems. This ICR reflects 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 ICR 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 ICR compared to the 

previous ICR. This is not due to any program changes. The previous ICR assumed all capital 

costs associated with monitoring were incurred during a single year. By contrast, this ICR 

calculates the average capital costs for new sources for each year covered under the ICR. 
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6(g) Burden Statement

The annual public reporting and recordkeeping burdens for this collection of information 

is estimated to average 115 hours per response. “Burden” means the total time, effort, or 

financial resources expended by persons to generate, maintain, retain, or disclose or provide 

information to or for a Federal agency. This includes the time needed to review instructions; 

develop, acquire, install, and utilize technology and systems for the purposes of collecting, 

validating, and verifying information, processing and maintaining information, and disclosing 

and providing information; adjust the existing ways to comply with any previously applicable 

instructions and requirements; train personnel to be able to respond to a collection of 

information; search data sources; complete and review the collection of information; and 

transmit or otherwise disclose the information.

An agency may not conduct or sponsor, and a person is not required to respond to, a 

collection of information unless it displays a valid OMB Control Number. The OMB Control 

Numbers for EPA regulations are listed at 40 CFR part 9 and 48 CFR chapter 15.

To comment on the Agency's need for this information, the accuracy of the provided 

burden estimates, and any suggested methods for minimizing respondent burden, including the 

use of automated collection techniques, EPA has established a public docket for this ICR under 

Docket ID Number EPA-HQ-OECA-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 system, select “search,” then key in the docket ID number identified 

in this document. The documents are also available for public viewing at the Enforcement and 

Compliance Docket and Information Center in the EPA Docket Center (EPA/DC), EPA West, 

Room 3334, 1301 Constitution 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 

holidays. The telephone number for the Reading Room is (202) 566-1744, and the telephone 

number for the docket center is (202) 566-1752. Also, you can send comments to the Office of 

Information and Regulatory Affairs, Office of Management and Budget, 725 17th Street, 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 Waste 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 

personhours per 

year

(E=CxD)

(F)

Management 

person hours 

per year

(Ex0.05)

(G)

Clerical 

person 

hours 

per 

year

(Ex0.1)

(H)

Total Cost

Per year b

1. Applications N/A

2. Survey and Studies N/A

3. Reporting requirements

 A. Read instructions 1 1 1 1 1 0.05 0.1 $111.35 

 B. Required activities

 Performance spec tests (certif.) for CMS c16 1 16 1 16 0.8 1.6 $1,781.65 

 Repeat performance spec tests (certif.) for CMS c, d16 1 16 0 0 0 0 $0 

 Development of operating information e160 1 160 1 160 8 16 $17,816.48 

 Annual update of operating information f20 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 i20 1 20 1 20 1 2 $2,227.06 

 Annual control equipment inspection i20 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 

personhours 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

 Notification of anticipated startup g2 1 2 1 2 0.1 0.2 $222.71 

 Notification of actual startup g2 1 2 1 2 0.1 0.2 $222.71 

 Notification 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 h2 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 j460 1 460 1 460 23 46 $51,222.38 

 Waste management plan k160 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 m8 1 8 1 8 0.4 0.8 $890.82 

 Report of initial CMS demonstration mSee 3B

 Annual report

 CMS emissions/operation parameters n32 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 conducted 

 during the year q 40 1 40 5 200 10 20 $22,270.60 

 Report of no exceedances o, p24 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 

personhours 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

 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 $189,411.47

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, shutdown, 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 s0.03 365 9.13 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 

personhours 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

 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 compliance

 tests See 3E

 Records of annual control equipment inspections See 3B

 Records of bag leak detection system alarms l1.5 52 78 3.3 257.4 12.9 25.7 $28,662.26 

 F. Time to train personnel t40 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 

Assumptions:

a We have assumed that the average number 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 of this ICR 

b This ICR uses the following labor rates: $121.44 per hour for Executive, Administrative, and Managerial labor; $100.23 per hour 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 ” Table 2. Civilian Workers, by 

occupational and industry group.” The rates are from column 1,’Total compensation.” The rates have been increased by 110 percent to account for the benefit 

packages available to those employed by private industry.

c We assume that performance specification to certify CMS is expected to take approximately 16 hours.

d We assume no failures of the initial CMS demonstrations; includes CO CEMS.

e We assume it will take160 hrs to develop the operating information.

f We assume that it will take 20 hours to update the operating information each year. 

gWe assume that it will take 8 hours to review the operating information with each operator.

h We assume 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 control equipment inspection will occur for all sources. 

j We assume that it will take 460 hours to develop the site selection analysis.

kWe assume that it will take 160 hours to develop the waste management plan.

l We assume 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 sources 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.

mWe assume that it will take 8 hours for each facility to review the 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 excess emissions.

q Assume 40 hours to review 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 perform 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 Part 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 

personhours 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. Attend initial performance test c32 1 32 0.08 2.56 0.13 0.26 $132.67 

2. Repeat performance test

A. Retesting preparation d12 1 12 1 12 0.6 1.2 $621.89 

B. Attend retesting e32 1 32 0.1 3.2 0.16 0.32 $165.84 

3. Litigation f NA

4. Excess emissions – enforcement activities g32 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 waste management plan 8 1 8 1 8 0.4 0.8 $414.60 
22

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 

personhours 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

 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 j6 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 m2 1 2 4 8 0.4 0.8 $414.60 

 Report of annual control equipment inspection n4 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 additional 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 excludes locality rates of 

pay. The rates have been increased by 60 percent to account for the benefit packages available to government employees. 

c We assume EPA personnel attend 8 percent of the initial performance tests.

d We assume that 20 percent will fail the initial performance test, and will have to repeat the performance test. 
23

e We assume 10 percent of re-tests are attended by EPA personnel. 

f This ICR does not account for litigation costs. 

gWe assume 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 assume only new large and medium sources will install baghouses. 

I We assume 6 person-hours per report per pollutant. For the three new HMIWI, nine pollutants are required to be tested. 

j We assume 1 person-hour per report per CMS. For HMIWI, assume each uses six CMS (flue gas temperature, secondary chamber temperature, charge weight, 

scrubber liquor pH, scrubber liquor flow, and scrubber energy input). 

kWe assume 20 percent of the affected facilities with recurrent burden will report monitoring exceedances. 

l We assume 6 person-hours per report per pollutant. For annual tests, there are three pollutants (PM, CO, and HCl) for all HMIWI. 

mWe assume 80 percent of the affected facilities with recurrent burden will report no excess emissions. 

n We assume it will take 4 hours to review the annual control equipment inspection report. 

o 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 semiannual report is shown in the table as only once per year to avoid double-counting.