ALTERNATIVE MONITORING PETITION FOR THE 

SOLID-LIQUID INCINERATOR 

Eli Lilly and Company

Tippecanoe Laboratories 

1650 Lilly Road 

Lafayette, IN 47909 

October 2005 

Revision: 7.0 

 
Eli Lilly and Company

Lafayette, Indiana Alternative Monitoring Petition

TABLE OF CONTENTS 

1.0 INTRODUCTION ................................................................................................................... 1 

2.0 ENGINEERING DESCRIPTION............................................................................................ 3 

2.1 KEY COMPONENTS ...................................................................................................... 3 

2.2 SYSTEM OVERVIEW..................................................................................................... 4 

3.0 CANDIDATES FOR ALTERNATIVE MONITORING UNDER §63.8(f) ................................. 6 

3.1 PARTICULATE MATTER CEMS.................................................................................... 7 

3.1.1 Indicator of Performance ................................................................................. 7 

3.1.2 Measurement Technique................................................................................. 7 

3.1.2.1 Operating Principles......................................................................... 7 

3.1.2.2 Installation Location ......................................................................... 9 

3.1.2.3 Installation........................................................................................ 9 

3.1.2.4 Instrument Span............................................................................... 9 

3.1.2.5 System Start Up (Initial Operation).................................................. 9 

3.1.2.6 PM CEMS Calibration Correlation Test (PM CEMS 

Certification)................................................................................... 12 

3.1.2.7 Routine Operation of the PM CEMS.............................................. 16 

3.1.2.8 Component Replacement .............................................................. 19 

3.1.2.9 Out of Control................................................................................. 19 

3.1.3 Use of the PM CEMS for Compliance with the HWC MACT PM 

Standard ........................................................................................................ 20 

3.1.4 Monitoring Frequency and Averaging Time .................................................. 20 

3.1.5 Rolling Block Average Calculations during Routine Checks and 

System Audits................................................................................................ 21 

3.1.6 Backup to the Particulate Matter CEMS........................................................ 22 

3.1.7 Deviations from Performance Specification 11 ............................................. 23 

3.2 MULTI-METALS CEMS ................................................................................................ 25 

3.2.1 Indicator of Performance ............................................................................... 25 

3.2.2 Measurement Technique............................................................................... 26 

3.2.2.1 Operating Principles....................................................................... 26 

3.2.2.2 Installation Location ....................................................................... 29 

3.2.2.3 Installation...................................................................................... 29 

3.2.2.4 Instrument Span............................................................................. 29 

3.2.2.5 System Start-up (Initial Operation) ................................................ 29 

3.2.2.6 System Start-up (Field Installation)................................................ 30 

3.2.2.7 Performance Specification Test..................................................... 31 

3.2.2.8 Routine Operation of the Multi-Metals CEMS................................ 34 

3.2.2.9 Component Replacement .............................................................. 37 

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3.2.2.10 Out of Control................................................................................. 37 

3.2.3 Use of the XACT Multi Metals CEMS to Demonstrate Compliance

with the HWC MACT Metals Standards ........................................................ 37 

3.2.4 Monitoring Frequency and Averaging Time .................................................. 37 

3.2.5 Block Average Calculations during Multi-Metals CEMS Daily Checks

and Ongoing Quality Assurance Checks....................................................... 39 

3.2.6 Multi-Metals CEMS Backup........................................................................... 39 

3.3 HYDROGEN CHLORIDE (HCl) CEMS......................................................................... 40 

3.3.1 Indicator of Performance ............................................................................... 40 

3.3.2 Measurement Technique............................................................................... 41 

3.3.2.1 Operating Principles....................................................................... 41 

3.3.2.2 Installation Location ....................................................................... 43 

3.3.2.3 Installation...................................................................................... 43 

3.3.2.4 Instrument Span............................................................................. 43 

3.3.2.5 System Start-up (Initial Operation) ................................................ 43 

3.3.2.6 System Start-up (Field Installation)................................................ 44 

3.3.2.7 Performance Specification Test..................................................... 44 

3.3.2.8 Routine Operation of HCl CEMS ................................................... 47 

3.3.2.9 Out Of Control................................................................................ 49 

3.3.3 Use of HCl CEMS for Demonstrating Continuous Compliance with 

the HCl/Cl2 HWC MACT Emission Standard................................................. 49 

3.3.4 Monitoring Frequency and Averaging Time .................................................. 50 

3.3.4.1 Rolling Average Calculations during HCl CEMS Daily

Calibration and Ongoing Quality Assurance Audits....................... 51 

3.3.4.2 Rolling Average Calculations during System Autopurge............... 51 

3.3.4.3 PM and HWC MACT Metals Rolling Average Calculations 

during Ecochem CEMS Daily Calibration and Ongoing

Quality Assurance Audits............................................................... 52 

3.3.5 Backup to the HCl CEMS.............................................................................. 52 

3.4 JUSTIFICATION FOR REQUEST FOR ALTERNATIVE MONITORING

METHOD....................................................................................................................... 53

4.0 ALTERNATIVE MONITORING CANDIDATES UNDER 63.1209(g)................................... 54 

4.1 STACK GAS FLOWMETER DAILY CHECK AND AUTOPURGE................................ 54 

4.2 COMBUSTION GAS FLOW RATE OPERATING PARAMETER LIMIT....................... 54 

4.3 CALCULATION OF ROLLING AVERAGES WHEN ALL ONE-MINUTE 

AVERAGE VALUES ARE NOT AVAILABLE................................................................ 55 

5.0 ALTERNATIVE MONITORING PETITION APPROVAL ..................................................... 56 

6.0 RELEVANT REFERENCES................................................................................................ 57 

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FIGURES 

Figure 1. Block Flow Diagram of Solid-Liquid Incinerator 

Figure 2. Sigrist Particulate Matter CEMS 

Figure 3. T149 CEMS Data Exchange 

Figure 4. Multi-Metals CEMS (XACT) 

Figure 5. Ecochem CEMS (HCl) 

Figure 6. Ecochem Dynamic Spiking Overview 

TABLES 

Table 1. Rotary Kiln Incinerator HWC MACT Operating and Emission Limits

APPENDICIES 

Appendix A: EPA Draft Guidance Document for PM CEMS 

Appendix B: XACT Multi-Metals CEMS Guidance Documents, Performance Specifications, and Quality 

Assurance Documents 

Appendix C: HCl CEMS Performance Specification, HCL CEMS Quality Assurance Documents 

Appendix D: Cited Performance Specifications and Quality Assurance Procedures

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1.0 INTRODUCTION 

Eli Lilly and Company (Lilly) operates a rotary kiln incineration system located at the Lilly Tippecanoe 

Laboratories in Lafayette, Indiana. The rotary kiln is referred to as the solid-liquid incinerator. The solidliquid incinerator is used to burn hazardous and non-hazardous solid wastes and hazardous liquid

wastes. The solid-liquid incinerator is subject to requirements of the hazardous waste combustor 

maximum achievable control technology (HWC MACT) rule under 40 CFR 63 Subpart EEE and the 

General Provisions under 40 CFR 63 Subpart A. 

The HWC MACT places considerable emphasis on continuous monitoring for demonstrating compliance 

with applicable emission standards and operating parameter limits. As such, facilities are required to

install continuous emission monitoring systems (CEMS) that continuously monitor and record emission 

data and continuous parametric monitoring systems (CPMS) that continuously monitor and record

operating data. Section 63.1209(a)(5) of the HWC MACT allows facilities to petition the Administrator 

under Section 63.8(f) of the General Provisions to use CEMS for compliance monitoring for particulate

matter, mercury, semivolatile metals, low volatile metals, and hydrochloric acid/chlorine gas in lieu of

complying with corresponding operating parameters. Section 63.8(f) of the General Provisions allows 

facilities to request approval of an alternative monitoring petition to use alternative CEMS to demonstrate 

compliance with the applicable MACT requirements. In addition, Section 1209(g) of the HWC MACT

allows facilities to submit an application to the Administrator to request approval of alternative monitoring

requirements to document compliance with operating limits monitored by parametric instruments. 

As required by the HWC MACT, Lilly will install and operate a CO and O2 CEMS to demonstrate 

compliance with the CO emission limit, corrected to 7% oxygen. Lilly is also proposing to install and

operate CEMS for multi-metals, particulate matter, and HCl to demonstrate attainment with the semivolatile metals, low-volatile metals, mercury, particulate matter, and HCl/Cl2 emission limits. Pursuant to 

Section 63.1209(a)(5) of the HWC MACT, Lilly will not be required to use CPMSs to continuously monitor

operating parameters identified in Section 1209 of the HWC MACT when CEMS are used to demonstrate

compliance with the metals, particulate matter, and HCl/Cl2 HWC MACT emission standards. However, 

when the CEMS are not in use, Lilly will operate CPMSs to monitor and demonstrate compliance with the 

corresponding operating parameter limits (OPLs) to avoid shutting down hazardous waste feed to the 

solids-liquids incinerator. Table 1 provides a summary of which HWC MACT standards will apply while

operating the alternative CEMS (CEMS mode), and which operating parameter limits will apply when a

CEMS are not in use (parametric mode). 

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Lilly submitted an earlier version of this Alternative Monitoring Petition to EPA in conjunction with the

Comprehensive Performance Test Plan in September 2003 to address alternative requests under Section

40 CFR 63.8(f) Use of an alternative monitoring method and 40 CFR 63.1209(g) Alternative monitoring 

requirements other than continuous emissions monitoring systems (CEMS). EPA responded to the 

majority of the parametric monitoring requests under 40 CFR 63.1209(g) in a letter dated February 27, 

2004 which was signed by George T. Czerniak, Chief of the Air Enforcement and Compliance Assurance

Branch, EPA Region 5. Therefore, those Section 1209(g) parametric monitoring requests formerly in

Section 4.0 of this document addressed by EPA’s February 27, 2004 letter have been removed from this 

revision of the Alternative Monitoring Petition. 

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2.0 ENGINEERING DESCRIPTION 

The key components of the solid-liquid incinerator are described below. The Comprehensive 

Performance Test (CPT) Plan for the solid-liquid incinerator provides a more detailed engineering

description of the incinerator. 

2.1 KEY COMPONENTS 

The following are the key components of the solid-liquid incinerator:

Waste Feed System – The waste feed system is designed to feed solid and liquid wastes to the rotary 

kiln, and liquid wastes to the secondary combustion chamber (SCC). 

Rotary Kiln – The rotary kiln is a refractory-lined cylinder that rotates while incinerating solid and liquid

wastes. 

Wet Ash Handling System – Hot, dry ash from the rotary kiln is cooled and has moisture added in the wet 

ash handling system. 

Vertical Up-Flow SCC – The combustion gases from the rotary kiln enter the SCC which is designed to

complete the combustion of the gases from the kiln, and to burn primary liquid (high BTU content) and

secondary liquid (low BTU content) wastes. 

NOx Abatement System – The hot combustion gases enter the selective non-catalytic reduction (SNCR) 

system which uses urea injection to reduce NOx emissions. The NOx Abatement System does not meet

the regulatory definition of a low or a high-energy wet scrubber and the operation of the NOx abatement 

system is not regulated by the HWC MACT regulations. 

Quench – The combustion gases from the NOx abatement system enter the quench where the 

combustion gases are cooled to their adiabatic saturation temperature. The quench is not designed nor 

intended to be an air pollution control device. The quench does not meet the regulatory definition of a low 

or a high energy wet scrubber and the operation of the quench is not regulated by the HWC MACT

regulations. 

Condenser/Absorber – The combustion gases from the quench enter the condenser/absorber where the

gases are cooled to below their adiabatic saturation temperature. The condenser/absorber provides

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additional conditioning of the combustion gases exiting the quench. The condenser/absorber is

considered a low energy wet scrubber according to the HWC MACT regulations

Hydro-SonicTM Scrubber – The combustion gases from the condenser/absorber enter the Hydro-Sonic 

scrubber where particulate and metals are removed from the combustion gas stream. Removal of acid

gases is also provided. Steam injection can be used to enhance the particulate removal. The HydroSonic scrubber is considered a high energy wet scrubber according to the HWC MACT regulations 

A block flow diagram of the solid-liquid incineration system is provided in Figure 1. 

2.2 SYSTEM OVERVIEW 

The incineration system is designed to combust solid as well as primary and secondary liquid wastes.

Solid wastes are fed through the solid waste feed system on the rotary kiln. Liquid wastes can be fed to

both the rotary kiln and SCC. The combustion gas from the treatment of the wastes is treated in a wet air 

pollution control (APC) system consisting of a NOx abatement system, a full quench, condenser/absorber, 

Hydro-Sonic scrubber, and stack. An induced draft fan is the combustion gas prime mover. 

The function of the quench is to adiabatically cool the combustion gas via saturating water sprays. The 

quench consists of a vertical, cylindrical, brick-lined chamber. Fresh and recirculating water is sprayed 

through quench nozzles to adiabatically saturate and cool the inlet combustion gas. 

Saturated combustion gas from the quench enters the lower portion of the condenser/absorber. 

Combustion gas flows up through the packed section. Recirculated water is introduced to the top of the

packed section and flows countercurrent to the combustion gas flow for additional combustion gas cooling

and conditioning. 

Combustion gas from the condenser/absorber flows to the Hydro-Sonic scrubber. The Hydro-Sonic 

scrubber removes fine particulate matter by inertial impaction. Particulate removal efficiency is a function

of the pressure differential across the Hydro-Sonic scrubber. The differential pressure is dependent on

the flow of combustion gases and water through the Hydro-Sonic scrubber. The combustion gas flow 

changes with changes in the incinerator conditions. The water flow to the Hydro-Sonics scrubber is a

combination of recirculated water and makeup water. Steam injection can be used to enhance the

particulate removal of the Hydro-Sonics scrubber. 

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An induced draft (ID) fan draws the combustion gas through the combustion chamber and APC system

and discharges the gases through an FRP (or equivalent) stack constructed with sampling ports and

platforms. 

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3.0 CANDIDATES FOR ALTERNATIVE MONITORING UNDER §63.8(f)

Lilly intends to install and operate a particulate matter CEMS, a multi-metals CEMS, and an HCl CEMS to 

demonstrate compliance with the particulate matter, metals, and HCl/Cl2 HWC MACT emission

standards. As previously stated, Section 1209(a)(5) of the HWC MACT allows Lilly to petition the 

Administrator under Section 63.8(f) of the General Provisions to use CEMS for compliance monitoring for 

particulate matter, mercury, semivolatile metals, low volatile metals, and hydrochloric acid/chorine gas in 

lieu of complying with the corresponding HWC MACT operating parameter limits. As required in Section

63.8(f), this application must contain a description of the proposed alternative monitoring system and

address the four elements contained in the definition of monitoring in Section 63.2 of the General

Provisions. Those four elements are as follows: 

1) Indicator(s) of Performance: The parameter or parameters you measure or observe for 

demonstrating proper operation of the pollution control measures or compliance with the

applicable emissions limitation or standard. Indicators of performance may include direct or 

predicted emissions measurements and may be expressed as a single maximum or minimum

value; 

2) Measurement Techniques: The means by which you gather and record information of or about 

the indicators of performance. The components of the measurement technique include the

detector type, location and installation specifications, inspection procedures, and quality 

assurance and quality control measures; 

3) Monitoring Frequency: The number of times you obtain and record monitoring data over a

specified time interval. Examples of monitoring frequencies include at least four points equally

spaced for each hour for CEMS; and 

4) Averaging Time: The period over which you average and use data to verify proper operation of 

the pollution control approach or compliance with the emissions limitation or standard. 

Pursuant to Section 63.8(f)(4)(ii), the application must also contain a performance evaluation test plan

(PETP) if requested. The detailed information contained in this petition meets the requirements of 40 

CFR 63.8(e)(3)(i) which specifies the information that must be contained in a CMS PETP. Therefore, the 

PETP requirements for the particulate matter CEMS, the multi-metal CEMS, and the HCl CEMS are met

through submission of the detailed alternative monitoring petition. 

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In addition, Section 3.4 of this alternative monitoring petition includes information justifying the request for

an alternative monitoring method, such as the technical or economic unfeasibility, or the impracticality, of

the affected source using the required method. This meets the requirements of Section 63.8(f)(4)(ii). 

3.1 PARTICULATE MATTER CEMS 

3.1.1 Indicator of Performance

The particulate matter CEMS is designed to continuously monitor the stack gas particulate matter

concentration. Compliance with the particulate HWC MACT emission standard is demonstrated when the

particulate matter measured stack concentration is less than or equal to the applicable standard. 

Currently, Lilly must comply with the interim PM standard of 34 mg/dscm, corrected to 7 percent oxygen, 

specified under Section 63.1203(b) of the HWC MACT. Lilly will comply with the HWC MACT final PM 

standard specified in Section 63.1219(a) no later than the date required by Section 1206(a)(1)(ii) of the

HWC MACT Final Replacement Standards. The averaging time for both the interim and final PM

standard is a 6-hour rolling average, updated every hour. 

3.1.2 Measurement Technique

3.1.2.1 Operating Principles 

The total particulate mass continuous emission monitoring system is a Sigrist Dust Emission Measuring 

System CTNR (or equivalent), manufactured by Sigrist Process-Photometer, AG. The Sigrist system is 

intended to measure particle mass concentration from the incinerator stack. It will withdraw a

representative sample of the exhaust from the stack and transport it, via the Sigrist ring pipe, for 

measurement by the photometer. The sample transport system maintains sample stream temperature at

approximately 160 o

C (320 oF). A portion of the sample stream is separated (reducing orifice) and

measured by the photometer, then merged back into the main sample stream for transport back into the

incinerator stack. A data acquisition system collects particle measurement data from the photometer 

through the Sigrist Controller. Figures 2 and 3 illustrate the major components of the Sigrist CEMS, which

include: 

1. Sample Extraction System

2. Photometer 

3. System Controller 

4. Data Acquisition System (DAS) and Historian 

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3.1.2.1.1 Sample Extraction System 

The Sigrist sample system consists of a sample probe and ring pipe. The sample probe size was 

selected by the manufacturer to provide an inlet gas velocity that is approximately 1.0 - 1.5 times greater

than the normal stack gas velocity when sampling at the preset (design) rate of approximately 1 acm/min. 

This super-isokinetic operating condition is used to minimize particulate measurement error that can be 

significant at sub-isokinetic conditions. The super-isokinetic condition is an alternative to continuous 

monitoring of the stack gas velocity and adjustment of the sampling rate in order to maintain isokinetic 

conditions. 

Stack gases are transferred through a ring pipe where the gas is conditioned by heating to approximately 

160 o

C (320 oF) to vaporize any water and acid droplets that may be present in the gas stream. A

slipstream of the sample gas is extracted for “continuous” analysis by the photometer, which is also

heated to 160°C and kept at a consistent pressure. After analysis, the slip stream gas passes through a

flow measurement venturi and returns to the bypass sample gas stream, which is forwarded by the 

blower, to the sample return probe in the stack. 

3.1.2.1.2 Photometric Analysis 

The PM analysis is performed by the photometer which measures the attenuation in forward light caused

by the PM present in the sample gas. The photometer measures forward light scattered at 15o

 from an

incandescent bulb emitting over the range of 360 to 2800 nanometers. Dual beam compensation is used

in which the light path is split and the intensity of the reference path is adjusted by an attenuator to equal

the intensity of the measurement path. The sample and reference scattered light are combined ahead of 

a photocell, which generates a photoelectric signal that is proportional to the concentration of PM in the

sample stream. The instrument response time is approximately 5 seconds. The photoelectric signal is 

amplified to 4 to 20 milliampere (mA) and output to the data acquisition system (DAS) on one of four 

available channels according to the increasing levels of intensity associated with increasing PM

concentration. An automatic switching device operates relays to block a signal being sent from the other 

three channels. The system can also operate in a single or locked range. The nominal PM

concentrations associated with the four measurement levels are 0-5, 0-1, 0-0.2, and 0-0.05 PLA based on

a polystyrene latex aerosol (PLA) used in factory calibration of the monitor. The monitor’s output signal,

however, is always a single current value in the 4 -20 mA range. 

3.1.2.1.3 System Controller 

The SIGAR 4000 controller, or equivalent, is the connecting link between the photometer, the sample 

transport system, and the DAS. It communicates with the photometer, and processes and displays the

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particle mass reading signal. The SIGAR controller operates the sample transport system valves, 

heaters, blowers, and temperature sensors. The controller outputs critical system information including

the real-time mass reading, sample transport system temperatures, and controller parameters. It stores 

all the threshold parameters for the Sigrist photometer. It provides relay contact input and outputs to 

signal photometer and sample transport system status. It provides the user interface for photometer and 

controller parameter setup and preservation. 

3.1.2.1.4 Data Acquisition System and Historian 

The Sigrist micro controller provides system operation, status, instrument output, and range identification 

to a computerized DAS. The DAS performs all data calculations for compliance. All data, system 

operation, status, and quality assurance data are stored in a historian. 

3.1.2.2 Installation Location 

The Sigrist PM CEMS will be located at a point in the stack that allows a representative sample to be

extracted for subsequent analysis. This location will be at least two duct diameters from the top of the

stack, and at least two duct diameters downstream from the last point of interference. The final PM

CEMS location will be determined during the correlation test. 

3.1.2.3 Installation 

The PM CEMS will be installed per manufacturer’s recommendations. The CEMS will be installed in a 

location such that the correlation between the PM CEMS response and emissions determined by a

reference method will meet the performance specifications stated in this document. Once the system is

installed, it will be commissioned for use. This exercise will verify the system is installed properly per the 

manufacturer’s specification. 

3.1.2.4 Instrument Span 

The operating range of the PM CEMS will be established during the CEMS initial startup and correlation 

test plan period. Lilly will verify that the operating range (zero to span) will encompass the response of

the PM CEMS for all expected waste streams. 

3.1.2.5 System Start Up (Initial Operation) 

The Sigrist will be started and allowed to run using ambient air in the sample line. A valve, located at the

probe, allows Lilly to start the system with ambient air as opposed to flue gas. The system will run on 

ambient air for approximately four weeks. During this time, Lilly will check the operation of the system

and correct any issues that arise. 

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After this approximate four-week period, Lilly will sample the flue gas under different feed conditions 

(surrogate material, liquid waste, solid waste, natural gas, fuel oil). Lilly will sample flue gas for 

approximately 4-8 weeks. The objective is to correct any issues that arise, and begin to compare the type

of waste burned to the output of the Sigrist. Linearity checks will begin during this phase of the PM CEMS 

operation. 

The linearity check is a procedure which checks the instrument drift at five levels. With an instrument

response range of 4 to 20 milliamps, the linearity test checks the instrument drift at approximately 4, 5, 8, 

12, and 16 milliamps. The percent drift will be calculated as: 

Percent Drift = *100

Span

RCEMS − RREF 

where: 

Percent Drift = Amount of drift (%) 

RCEMS = The measured PM CEMS response (mA)

 RREF =The PM reference standard value (mA) 

Span =Span of the instrument (20 mA) 

3.1.2.5.1 Preliminary Correlation Test Plan Period 

The intent of the preliminary correlation test plan period (PCTPP) during the PM CEMS startup is to: (1) 

understand the affect of specific materials (surrogate material and/or hazardous waste) on the response 

of the Sigrist PM CEMS (2) establish a preliminary correlation to predict particulate mass in terms of 

mg/scm, based on the output of the PM CEMS. It is expected that the PCTPP will take up to 16 weeks. 

Activities during the PCTPP will follow guidance in 40 CFR 60 Appendix B, Performance Specification 11

(PS11). The following activities will be conducted during the PCTPP: 

Seven-Day Drift: Prior to beginning the PCTPP, the PM CEMS will have passed a seven-day drift test. 

For seven consecutive days, the linearity check will be completed. The percent drift at five levels will be 

recorded. Each value must be within 5% of the reference value. 

Reference Method: During the PCTPP, Lilly will use Method 5 or Method 5i as the reference method. 

Lilly will use dual trains (perpendicular trains) for the reference method (RM) sampling. The targets are 

60-minute runs. Shorter or longer runs may be necessary. For example, for high particulate loading, the 

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test runs may only be 45 minutes due to excessive pressure drop across the filter, and for very low 

particulate loading, test runs may be 120 minutes. The averaging time for each run will be documented. 

Lilly will treat each sample train result in the data set as an individual data point. 

Data range: During the PCTPP, Lilly will collect at least 15 valid data sets consisting of simultaneous PM

CEMS and dual RM measurements. More may be collected so that certain test results may be rejected. 

Lilly will attempt to collect data in three ranges [(Low) from zero to 50% of maximum measured PM 

concentration; (Mid) 25 – 75% of the maximum measured PM concentration; and (high) 50 to 100 % of

the maximum measured PM concentration]. The goal is to have at least 20% of the total data in each of

the three ranges. A data set can only be used for one range. Lilly will use zero point data for the low 

values if a response at the low level cannot be achieved. 

Reference Method Data: During the PCTPP, Lilly will evaluate the precision of the two sample trains by 

determining the relative standard deviation (RSD) for each paired data set and comparing it to the 

recommended maximum RSD. The RSD will be calculated for each test run using the following equation: 

( )

( ) 100*

a b

a b

C C

C C

RSD

+

− =

where: 

RSD = relative standard deviation (%) 

Ca = concentration measured using Train A, units of concentration

Cb = concentration measured using Train B, same units as Ca. 

Pursuant to Section Z.1.4 of EPA’s Draft Guidance Document on PM CEMS, the recommended maximum

RSD will be determined as follows: 

• For average PM concentrations that are at least 10 mg/dscm (or at least 10 mg/acm), 

the recommended maximum RSD is 10%

• For average PM concentrations that are less than or equal to 1.0 mg/dscm (or less 

than or equal to 1.0 mg/acm), the recommended maximum RSD is 25%; and 

• For average PM concentrations between 1.0 and 10 mg/dscm (or between 1.0 and 

10 mg/acm), the recommended maximum RSD is determined using the following 

equation: 

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(26.67 1.67 ) RSDr = − Cave

where: 

RSDr = recommended maximum RSD for average PM concentration between 1.0

and 10 mg/dscm, (%). 

 Cave = average PM concentration for the Trains A and B, units of concentration 

EPA’s draft guidance document on PM CEMS is provided in Appendix A. 

If the RSD analysis shows that the data for all test runs are within the recommended maximum RSD, no

further assessment of data precision will be performed. If the RSD shows one or more outliers, Lilly will

use the standardized residual method. Under the standardized residual method, Lilly will plot data that

compares Train 1 sampling results to Train 2 sampling results. The linear relationship must have a slope

falling between 0.93 and 1.07. Data sets will be removed until the reference method data meets this

criterion. 

Preliminary Correlation Development: Valid reference method data (Train 1 and Train 2 as individual 

points) will be plotted against the Sigrist output (mA or PLA) averaged over the sample period. The

average Sigrist output will be on the X-axis and RM result, in mg/scm (to represent the conditions in 

sample train standardized to standard temperature and pressure) on the Y-axis. Using the equations in

PS11, Lilly will calculate up to five correlations (1) linear (2) polynomial (3) logarithmic (4) exponential (5) 

power correlation models. Each attempted correlation will have the correlation coefficient, tolerance

interval, and confidence interval calculated as described in PS11. Lilly will compare the correlation 

coefficient, confidence interval, and tolerance interval to the limits in PS 11. A successful preliminary 

correlation will be obtained, that uses real-time CEMS values to predict PM concentrations in mg/scm, if 

all statistical checks in PS11 are met. 

During the correlation development, drift from the linearity checks will be recorded daily. If the drift, for 

any of the values, exceeds 8%, the PM CEMS will be adjusted and a new drift test performed. 

3.1.2.6 PM CEMS Calibration Correlation Test (PM CEMS Certification) 

The objective of the calibration correlation test period (CCTP) is to collect data, while burning hazardous 

waste, to establish a correlation which will predict total particulate mass emissions, in mg/scm, based

upon the output of the Sigrist PM CEMS. PS 11 will be used as guidance to establish a valid calibration 

correlation. 

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The following activities will be conducted during the CCTP: 

Seven day Drift: Prior to beginning the CCTP, the PM CEMS will have passed a seven day drift test 

pursuant to Section 8.5(3) of PS 11. For seven consecutive days, the linearity check will be completed.

The percent drift at five levels will be recored. Each value must be within 5% of the reference value. 

Absolute Correlation Audit: The absolute correlation audit (ACA) evaluates the PM CEMS response to a

series of reference standards covering a full measurement range of the instrument. To conduct this audit 

the PM CEMS will be challenged three times at each of the five audit points. Lilly will follow Section 

10.3(2) of 40 CFR 60 Appendix F Procedure 2 (Procedure 2) as guidance for conducting the ACA. The

average response will be used to calculate the accuracy at each audit point. The ACA will be calculated

using the equation in Procedure 2 listed below. The error cannot exceed 10% of the audit value, or 7.5%

of the applicable standard; whichever is greater. 

ACA Accuracy = *100

REF

CEMS REF

R

R − R

where: 

ACA Accuracy = The ACA accuracy at each audit point, (%) 

RCEMS =the measured PM CEMS response to the reference standard (mA)

 RREF =the PM reference standard value (mA) 

Stratification Test: Lilly will test for PM stratification by following the same general steps specified for 

gaseous pollutants, and following the guidance specified in Section V.5 of EPA’s Draft Guidance

Document on PM CEMS. To determine whether effluent stratification exists, a dual probe system will be

used to determine the average effluent concentration while measurements at each traverse point are

being made. One probe, located at the stack centroid, will be used as a stationary reference point to 

indicate change in the effluent concentration over time. The second probe will be used for sampling at the 

traverse points specified in Method 1 (40 CFR part 60 appendix A). The monitoring system samples 

simultaneously at the reference and traverse points throughout the testing period for approximately fifteen 

minutes at each point. A minimum of 12 sampling points will be used, with 6 sampling points along each 

of the two traverses. Lilly will use Method 5 as the sampling method and sample at least 15 minutes at 

each sampling point. 

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The PM concentrations at each traverse point are then compared to the average of the PM

concentrations for all sampling points to determine the percent stratification using the following equation: 

S = Ci −Cave *100% 

where: 

S = percent stratification 

 Ci

 = PM concentration at sampling point 

 Cave = average PM concentration for all sampling points. 

If the percent stratification is less than or equal to 10 percent for any traverse point, the duct is not 

considered stratified at that location. 

Reference Method: Lilly will use Method 5 or Method 5i as the reference method. Lilly will use dual trains

(perpendicular trains) for the reference method (RM) sampling. The targets are 60-minute runs. Shorter 

or longer runs may be necessary. For example, for high particulate loading, the test runs may only be 45

minutes due to excessive pressure drop across the filter, and for very low particulate loading, test runs

may be 120 minutes. The averaging time for each run will be well documented. Lilly will adhere to PS11

and treat each sample train result in the data set as an individual data point. 

Data range: Lilly will adhere to PS11 for the data collection. This requires at least 15 valid data sets

consisting of simultaneous PM CEMS and dual RM measurements. More may be collected so that

certain test results may be rejected as long as at least 15 valid data sets are used to determine the 

correlation. All data will be reported. 

Lilly will attempt to collect data in three ranges [(Low) from zero to 50% of max PM concentration; (Mid) 

25 – 75% of the max PM concentration; and (high) 50 to 100 % of the max PM concentration]. The goal

is to have at least 20% of the total data in each of the three ranges. A data set can only be used for one

range. Lilly will use zero point data for the low values if a response at the low level cannot be achieved. 

While collecting total particulate mass data during the CCTP, the intention is to collect total particulate 

data that is close to, but not significantly greater than the total particulate mass emission standard.

However, because the purpose of CCTP is to develop an acceptable correlation that can verify

compliance at the emission standard, it is impossible to ensure that the total particulate mass emission

standard will not be exceeded during some of the test runs. Accordingly, emissions standards from parts 

60, 61, 63, 264, 265, and 266 of Title 40 of the Code of Federal Regulations do not apply while

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conducting a correlation testing program. Any permit or other emissions or operating parameter limits or

conditions, including any limitations on work place practices, that are applicable to ensure compliance

with the emissions standards of parts 60, 61, 63, 264, 265, and 266 of Title 40 of the Code of Federal

Regulations also do not apply while conducting a correlation testing program. 

Reference Method Data: Lilly will evaluate the precision of the two sample trains by determining the 

relative standard deviation (RSD) for each paired data set and comparing it to the recommended

maximum RSD. Lilly will follow the guidance provided in Section Z.1.4 of EPA’s Draft Guidance Document

on PM CEMS. The RSD will be calculated for each test run using the following equation: 

( )

( ) 100 *

a b

a b

C C

C C

RSD

+

− =

where: 

RSD = relative standard deviation (%) 

Ca = concentration measured using Train A, units of concentration

Cb = concentration measured using Train B, same units as Ca 

Pursuant to Section Z.1.4 of EPA’s Draft Guidance Document on PM CEMS, the recommended maximum

RSD will be determined as follows: 

• For average PM concentrations that are at least 10 mg/dscm (or at least 10 mg/acm), 

the recommended maximum RSD is 10%

• For average PM concentrations that are less than or equal to 1.0 mg/dscm (or less 

than or equal to 1.0 mg/acm), the recommended maximum RSD is 25%; and 

• For average PM concentrations between 1.0 and 10 mg/dscm (or between 1.0 and 

10 mg/acm), the recommended maximum RSD is determined using the following 

equation: 

(26.67 1.67 ) RSDr = − Cave

where: 

RSDr = recommended maximum RSD for average PM concentration between 1.0

and 10 mg/dscm, (%). 

 Cave = average PM concentration for the Trains A and B, units of concentration 

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If the RSD analysis shows that the data for all test runs are within the recommended maximum RSD, no

further assessment of data precision will be performed. If the RSD shows one or more outliers, Lilly will

use the standardized residual method. Under the standardized residual method, Lilly will plot data that

compares Train 1 sampling results to Train 2 sampling results. The linear relationship must have a slope

falling between 0.93 and 1.07. Data sets will be removed until the reference method data meets this

criterion. All data will be saved and submitted. Regardless of which method is used, any potential outliers 

will be investigated to determine possible causes for the lack of precision. 

Correlation Development: Valid reference method data (Train 1 and Train 2 as individual points) will be 

plotted against the Sigrist output (mA or PLA) averaged over the sample period. The average Sigrist 

output will be on the X-axis and RM result, in mg/scm (to represent the conditions in sample train

standardized to standard temperature and pressure) on the Y-axis. Using the equations in PS11, Lilly will 

calculate up to five correlations (1) linear (2) polynomial (3) logarithmic (4) exponential (5) power 

correlation models. Each attempted correlation will have the correlation coefficient, tolerance interval,

and confidence interval calculated as described in PS11. Lilly will compare the correlation coefficient, 

confidence interval, and tolerance interval to the limits in PS 11. A successful correlation will be 

established that uses real-time CEMS values to predict particulate concentration in mg/scm if all statistical

checks in PS11 are met. If the PM CEMS does not pass the statistical limits for any of the five

correlations, Lilly, with appropriate agency review, may develop an alternative correlation by providing an 

explanation of how compliance demonstration would be assured.

The correlation established during the CCTP for the PM CEMS will supersede any previous correlations, 

which may have been established. 

During the CCTP, drift from the linearity checks will be recorded daily. If the drift, for any of the values,

exceeds 8% once, the PM CEMS will be adjusted and a new drift test performed. 

3.1.2.7 Routine Operation of the PM CEMS 

3.1.2.7.1 On-Going Quality Assurance 

This section describes the on-going quality assurance that will be performed on the PM CEMS to ensure 

that it continues to operate correctly and produces valid data. These quality assurance activities will

occur only when the PM CEMS is operational. Lilly will follow Procedure 2 and EPA’s Draft Guidance 

Document on PM CEMS located in Appendix A of this document when performing on-going quality 

assurance on the PM CEMS. 

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3.1.2.7.2 Routine System Checks 

Daily checks of the PM CEMS will be done according the recommended checklist provided by Sigrist, as

modified by Lilly. Data status flags will be used to troubleshoot any problems that arise in the PM CEMS 

system. This meets the intent of the daily system checks in PS11. 

3.1.2.7.3 Weekly Linearity Drift Checks 

Lilly will perform a linearity check once per week. This will be performed manually according to the

procedure outlined in the Sigrist operational manual. 

The percent drift is calculated as: 

% Drift = *100

Span

RCEMS − RREF

where: 

% Drift = Drift of the CEMS (%) 

RCEMS = the measured PM CEMS response (mA)

 RREF =the PM reference standard value (mA) 

Span =Span of the instrument (20 mA) 

Five values between 0-20 mA will be checked. The actual value(s) will be adjusted when the drift 

exceeds 5% for any of the five values. (Refer to Section 3.1.2.9 for out of control definition). 

The Sigrist will be off-line for up to one hour during the linearity check. All calibration data collected along

with the drift percentage will be recorded. During this time, the 6-hour rolling block average will be frozen. 

3.1.2.7.4 System Audits 

3.1.2.7.4.1 Quarterly Absolute Correlation Audit (ACA) 

The absolute correlation audit (ACA) evaluates the PM CEMS response to a series of reference

standards covering a full measurement range of the instrument. To conduct this audit, Lilly will perform

the linearity drift check. The PM CEMS will be challenged three times at each of the five audit points. The 

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average response will be used to calculate the accuracy at each audit point. The ACA will be calculated

using the Equation 2-1 in Procedure 2 as follows: 

ACA Accuracy = *100

REF

CEMS REF

R

R − R

where: 

ACA Accuracy = Accuracy of the CEMS (%) 

RCEMS = the measured PM CEMS response (mA)

 RREF =the PM reference standard value (mA) 

The error cannot exceed 10% of the audit value, or 7.5% of the applicable standard; whichever is greater.

The ACA will be performed each quarter. 

3.1.2.7.4.2 Quarterly Relative Response Audit (RRA) 

The relative response audit (RRA) is a brief series of tests conducted between annual full response

correlation audits (RCA) to assure the continued validity of the PM CEMS correlation. The RRA will be 

performed by collecting, at current source conditions, three reference method samples and PM CEMS

measurements at the as-found source operating conditions. The data points will be plotted on the current 

calibration correlation function. To meet the RRA performance criteria, the three points must be less than

or equal to the highest CEMS values used for the calibration curve and two of the three sets of PM CEMS 

and RM measurements must fall within a specified area on the graph of the calibration correlation

function. The specified area is two lines parallel with the correlation regression curve, offset at a distance 

of ± 25% of the numerical emission limit value from the correlation regression curve. 

If the PM CEMS does not meet the RRA criteria, Lilly will take the necessary corrective action to eliminate

the problem and repeat the test. If the RRA criteria cannot be achieved, Lilly will perform an RCA. 

3.1.2.7.4.3 Annual Response Correlation Audit (RCA) 

Lilly will perform a response correlation audit (RCA) annually. The quarterly RRA will not be performed in

the same quarter that the annual RCA is preformed. The response correlation audit (RCA) is a series of 

tests conducted to assure the continued validity of the PM CEMS correlation. Lilly will conduct the RCA 

as prescribed in PS11 and Procedure 2. Lilly will collect a minimum of 12 data points attempting to 

disperse the points through low, mid, and high ranges on the calibration correlation function. The points

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will be plotted on the current calibration correlation function. To meet the RCA criteria, 75% of the points 

must fall within a specified area on the correlation regression curve. The specified area is two lines

parallel with the calibration correlation function, offset at a distance of ± 25% of the numerical emission

limit value from the correlation regression curve. 

As defined in Section 10.6 of Procedure 2, if Lilly does not meet the performance criteria, then the two 

data sets (current correlation and the current RCA) will be combined and the correlation statistics in PS11 

applied. If a correlation from the combined data sets passes the statistical limits, this correlation becomes 

the new correlation curve. If the statistical limits are not met with the combined data, Lilly will use only the 

RCA data and run the PS11 statistics. If the statistical limits are met, this is the new correlation curve. If 

the statistical limits are not met for the RCA data, the correlation test will be redone with a minimum of 15

data points, applying the statistics in PS11. If the new data do not meet the statistical criteria for any of 

the five PS11 equations, and assuming no definable problems exist with the PM CEMS, Lilly, with

appropriate agency review, may develop an alternative correlation by providing an explanation of how 

compliance demonstration would be assured. 

While collecting total particulate mass data during the RCA, the intention is to collect total particulate data

that is close to, but not significantly greater than the total particulate mass emission standard. However, 

because the purpose of RCA is to verify that the correlation is suitable for complying with the emission

standard, it is impossible to ensure that the total particulate mass emission standard will not be exceeded 

during some of the test runs. Accordingly, emissions standards from parts 60, 61, 63, 264, 265, and 266

of Title 40 of the Code of Federal Regulations do not apply while conducting a correlation testing

program. Any permit or other emissions or operating parameter limits or conditions, including any 

limitations on work place practices, that are applicable to ensure compliance with the emissions 

standards of parts 60, 61, 63, 264, 265, and 266 of Title 40 of the Code of Federal Regulations also do

not apply while conducting a correlation testing program. 

3.1.2.8 Component Replacement 

During normal operation of the PM CEMS, specific components will need to be replaced. The PM CEMS

standard operating procedures will address the criteria to be met upon replacement of significant 

components. 

3.1.2.9 Out of Control 

Lilly will adjust the PM CEMS when the drift is equal to or greater than 5%. Lilly will consider the PM

CEMS out of control if drift, for any of the five values, exceeds 8%. In addition, the CEMS will be deemed 

out of control if the PM CEMS fails to meet the RCA criteria, RRA criteria, or ACA criteria. 

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The out of control period will begin immediately after the last test run or check of an unsuccessful RCA, 

RRA, ACA, or linearity drift check. The out of control period ends immediately after the last test run or

check of the subsequent successful audit or drift check, when the metals CEMS is used as a back-up, or 

when the incinerator enters parametric mode. When the incinerator is operating in parametric mode, the

PM CEMS will not be deemed out of control. 

3.1.3 Use of the PM CEMS for Compliance with the HWC MACT PM Standard 

Lilly may begin using the PM CEMS to demonstrate continuous compliance with the HWC MACT PM

emission standard only after the following is achieved:

• A successful PM CEMS Calibration Correlation Test as specified in Section 3.1.2.6 following

EPA’s approval of this Alternative Monitoring Petition. 

• A modification to the Title V permit is approved that incorporates the requirements of the 

approved Alternative Monitoring Petition. 

Following completion of the above, on-going quality assurance will be performed on the PM CEMS as 

specified in Section 3.1.2.7 of this document. 

3.1.4 Monitoring Frequency and Averaging Time 

The PM CEMS will provide a six-hour rolling block average in mg/dscm corrected to 7% oxygen. The sixhour block average was selected as representative of the time period to collect three manual particulate

measurement samples. One-minute values will be used to develop 15-minute average values, which will

be used to develop one-hour block average values and six-hour rolling block average values. 

Using the equation from the calibration correlation, the PM CEMS output values will be converted to 

mg/scm each minute. The Ecochem CEMS will send the DAS one-minute average oxygen and moisture

values to use to correct the PM CEMS values to mg/dscm at 7% oxygen. 

The particulate stack concentration will be corrected to 7% oxygen by the following equation: 

21 2

21 7 *

O

PM corr PM uncorr −

− =

where: 

PMcorr = PM concentration corrected to 7% oxygen (mg/dscm) 

PMuncorr = PM stack gas concentration (mg/dscm) 

 O2 = Oxygen stack gas percent (vol % dry) 

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The 15-minute data is the average of the one-minute data within that block of time. Only one valid oneminute value is required to achieve a valid 15-minute average value. 

The hourly block average will be calculated from the four 15 minute averaged values during the hour as 

shown in the following equation: 

4

4

1

∑= = i

Ci

HBA

where: 

HBA = Hourly block average value (mg/dscm corrected to 7% O2) 

Ci = a fifteen minute observation from the CEMS analyzer (mg/dscm corrected to 7% O2.) 

In the event that four valid 15-minute averaged values are not available to calculate an hourly block 

average (i.e. the CEMS produced problematic data), valid results must be available for at least three 15-

minute cycles of operation to calculate a one-hour block average. 

The six-hour rolling average will be calculated based on the average of the six most recent hourly block 

averages as shown in the following equation: 

6

6

1

∑= = i

HBA

SHRA

where: 

SHRA = Six hour rolling average value (mg/dscm corrected to 7% O2) 

HBA = Hourly block average value (mg/dscm corrected to 7% O2) 

The six-hour rolling block average will be updated every hour when a new, valid, hourly block average is 

calculated. 

3.1.5 Rolling Block Average Calculations during Routine Checks and System Audits 

Lilly will put the PM CEMS in a non-measure mode once per week for up to one hour in order to perform

the weekly linearity checks while burning hazardous waste. During this time, block average calculations

will be frozen. Rolling block hour average calculations will resume once the linearity check is successfully 

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performed. The six-hour rolling block average calculations will resume by adding the first valid hour block 

average after the linearity check to the previous five hour block average values. 

The rolling average calculations will also be frozen during the quarterly absolute correlation audits. Block 

hour average calculations will resume once the audit is complete. The ACA auditing may take more than 

one hour to complete. 

The PM CEMS DAS uses the oxygen concentration and moisture content from the Ecochem CEMS to 

correct the one minute average mg/scm concentrations of PM to 7% oxygen, dry basis. Once per day,

the Ecochem will be in calibration mode for up to one hour. During this time the PM block average will 

also be frozen. Incinerator operations will attempt to maintain stable operating parameters during times 

of calibration.

3.1.6 Backup to the Particulate Matter CEMS

In the event the PM CEMS is not operating, Lilly will have the option to use the multi-metals CEMS as a 

backup to the PM CEMS under the following conditions: 

1. Results obtained from parallel operation of the two CEMS will be used to develop a technical

justification of how the metals CEMS provides reasonable assurance of compliance with the PM

emission standard. 

2. When the PM CEMS is not operating and the multi-metals CEMS begins use as a backup, Lilly 

will use its best efforts to avoid introducing new waste streams (i.e. those that have not been 

historically burned while the two CEMS were in parallel operation) from the six “in-feed” 

conveyors to the final “merge” conveyor that leads to the kiln feed chute. 

In order to allow CEMS mode to establish waste streams that are not “new” during its initial

implementation period, the above restrictions on use of the multi-metals CEMS serving as a backup for 

the PM CEMS will apply only after a sufficient time period has elapsed (not to exceed 6 months from the 

first CEMS mode operation) for Lilly to gain experience while processing a variety of existing solid waste

streams. Finally, Lilly will attempt to maintain nominally stable or historically lower feed rates of waste 

while the backup is being used, and will limit the use of the multi-metals CEMS as a back up for the PM

CEMS to 14 consecutive days per episode. 

Lilly will use its best efforts to minimize the time that the multi-metals CEMS acts as a backup to the PM 

CEMS. To facilitate its efforts, Lilly will keep spare parts in stock and will maintain a service relationship 

with the PM CEMS manufacturer, or other qualified consultants, to minimize downtime. If both the PM 

CEMS and the multi-metals CEMS are not in use, Lilly will monitor operating parameter limits defined in

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Section 1209 of the HWC MACT (i.e. parametric operation). Details of the specific operating limits are

provided in the Notification of Compliance (NOC). 

Lilly will incorporate delays when transitioning from the CEMS mode of operation to the parametric mode 

of operation. Specifically, once the primary PM CEMS and the backup multi-metals CEMS are 

unavailable, the control system will automatically switch to the parametric mode of operation. Rolling

averages, related to the Air Pollution Control System (APCS), will not start until the system has been 

under the parametric mode of operation for 10 minutes. This 10-minute time period will allow Lilly time to 

make any adjustments to the APCS to bring the system to within the respective operating parameter

limits. In addition, up to four hours will be allowed before re-starting constituent feed rate rolling average 

operating parameter limits in order to clear the solid feed conveyor system. (Note that, in a similar 

fashion to the “backup” scenario described above, Lilly will use its best efforts to avoid introducing “new” 

waste streams from the six “in-feed” conveyors to the final “merge” conveyor that leads to the kiln feed 

chute during this four hour period. However, during initial CEMS mode operation periods there will be 

practical limitations to this criterion because few waste streams will have been burned.) Feed rates will 

be maintained nominally stable or historically lower than when operating in CEMS mode. If the CEMS 

mode of operation is still not available after four hours, the transition to parametric mode will be

completed and only waste with known composition will be processed in the incinerator so that constituent

feed rate operating parameter limits can be computed. 

3.1.7 Deviations from Performance Specification 11

• The Sigrist PM CEMS samples superisokinetic and may not continuously meet the requirement

of plus or minus 10% isokinetic. The Sigrist system is designed to sample superisokinetic. This 

is normally about 1.2 to 1.5 times isokinetic. Because of the Sigrist design, Lilly cannot be sure

that the system will always be within ±10% of isokinetics. Lilly will adhere to PS11 and provide 

data indicating that isokinetic sampling is not necessary. This data will consist of particulate size 

distribution data showing the PM is predominately small particles; thus acting as a gas. The

particulate size distribution data will be collected during the Comprehensive Performance Test.

• The calibration correlation function will plot Sigrist values (mA or PLA) on the X-axis and the

reference method average in units of mg/scm on the Y-axis. PS11 indicates that the reference

method values for PM should be in the same units as the CEMS (the Sigrist units are mg/Sigrist

m3

). Based upon the experience with the Sigrist at Lilly (PM CEMS demonstrations 1 and 2),

Lilly saw no affect upon the correlation by correcting the Method 5 units to units of the Sigrist. 

The operating pressure inside the photometer is not well defined, making correction to this 

pressure an unknown. Based upon experience, Lilly will standardize the RM data to mg/scm

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(68°F and 29.92 inches). This is also consistent with the way Lilly’s Kinsale, Ireland facility has 

established valid correlations to the two Sigrist units operated at that facility. 

• Lilly will use up to 20% of the correlation data (low range only) for zero points if low PM data

cannot be produced. It is important to provide PM emission data for the correlation that is 

spread across the desired range of measurement. Often, data at the low end of the range is 

difficult to obtain. Given this fact, using zero points for the low data may be required. 

• Lilly will conduct a seven-day drift prior to the calibration correlation. This will be the linearity 

check procedure described in the Sigrist operation manual (checks 5 values between 0-20 mA), 

which is a manual exercise each day for seven days. The criteria will default to the allowable

drift recommended by Sigrist of 5% as opposed to 2% of the span indicated in PS11. Use of the

Sigrist for compliance to a PM standard is new in the US. In our experience, the criteria

specified above are sufficient to understand the drift of the unit and is acceptable based on our 

PM CEMS demonstrations. Sigrist (the CEMS manufacturer) supports using the above criteria. 

• PS11 stipulates immediate compliance with QA/QC requirements (Procedure 2) upon

successfully completing the correlation test outlined in PS11. Lilly will comply with Proposed 

Procedure 2 after final correlation and statistics have been established and the Sigrist PM 

CEMS is deemed ready for use as a compliance tool. Until then, Lilly will use another means 

(surrogate operating parameters or the multi-metals CEMS) to assure compliance with the PM

standard if waste is being burned in the solid-liquid incinerator. 

• Appendix F, Procedure 2 does not discuss time to calibrate for the Sigrist. Lilly will put the

Sigrist in a non-measure mode once per week for up to one hour while continuing to burn

hazardous waste in order to perform the calibration checks. 

• Linearity drift will be checked once per week, not once per day. Lilly will follow PS11 on 

adjusting the zero or upscale value when the drift, per the Procedure 2 equation, is greater than 

5%. Sigrist recommends checking the zero and or upscale drift not more than once per week. 

Since the photometer compensates for electronic drift during each sample, checking the zero

and upscale drift daily is of no value. NOTE: The weekly calibration drift check will check five 

values within the 0 – 100% range of the PM CEMS. This exceeds the zero and upscale drift 

range requirements. 

• PS11 deems the CEMS out of control if the daily, zero or upscale drift exceeds 4% for five

consecutive days, or 8% once. Lilly will adhere to the 8% requirement as described in section

3.1.2.9. 

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• While performing the quarterly ACA the PM CEMS may be off-line for greater than one hour per 

day. The time off-line will not require use of either the multi-metals CEMS or surrogate 

parameters to demonstrate compliance with the HWC MACT. The quarterly audits will not 

require the use of parametric mode. 

3.2 MULTI-METALS CEMS 

3.2.1 Indicator of Performance

Lilly has voluntarily chosen to use a multi-metals CEMS to demonstrate continuous compliance with the

HWC MACT metals emission limits. Using a CEMS to monitor stack gas concentrations of metals is a

relatively new application and as such, the HWC MACT does not require facilities to install and operate a 

multi-metals CEMS for HWC MACT compliance purposes. 

The multi-metals CEMS is designed to continuously monitor the stack gas concentration of mercury, 

arsenic, chromium, cadmium, and lead to demonstrate compliance with the HWC MACT metals emission

limits. Compliance with HWC MACT metals emission standards will be demonstrated when the 

measured stack metals concentrations are less than or equal to the applicable standards. Currently, Lilly 

must comply with the HWC MACT interim standards under 40 CFR 63.1203(b). Compliance with the 

interim HWC MACT mercury standard will be demonstrated when the measured stack concentrations of 

mercury is less than or equal to 45 ug/dscm corrected to 7% oxygen over a 12-hour rolling averaging 

period, updated hourly. Compliance with the low volatile metals HWC MACT interim emission standard

will be demonstrated when the measured stack concentrations of arsenic and chromium and default 

levels of beryllium (see section 3.2.2.1) are less than or equal to 97 ug/dscm combined, corrected to 7%

oxygen over a 12-hour rolling averaging period, updated hourly. Compliance with the semi-volatile metals 

interim HWC MACT emission standard will be demonstrated when the measured stack concentrations of

lead and cadmium are less than or equal to 120 ug/dscm combined, corrected to 7% oxygen over a 12-

hour rolling averaging period, updated hourly. 

Lilly will comply with the HWC MACT final replacement metals emission standards specified in Section 

63.1219(a) no later than the date required by Section 1206(a)(1)(ii) of the HWC MACT Final Replacement 

Standards. 

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3.2.2 Measurement Technique

3.2.2.1 Operating Principles 

The multi-metals CEMS is an X-ray based continuous emission monitor (XACT) manufactured by Cooper

Environmental Services LLC (or equivalent). The XACT extracts a representative stack gas sample and

concentrates the particulate and gas phase metals on a chemically-reactive filter. The concentrations of 

metals in the filter deposits are measured with an energy-dispersive X-ray fluorescence (XRF) analyzer. 

Figures 3 and 4 schematically illustrate the major components of the XACT, which include: 

1. A sample extraction system

2. A sample collection module 

3. A metals analysis module 

4. A flow control module 

5. A system control module 

6. A PC interface 

7. A Data Acquisition System and Historian 

The XACT is designed to measure the concentration of up to 20 elements, including antimony (Sb), 

arsenic (As), barium (Ba), cadmium (Cd), chromium (Cr), cobalt (Co), lead (Pb), manganese (Mn), 

mercury (Hg), nickel (Ni), selenium (Se) silver (Ag), and thallium (Tl). 

Because the XACT is incapable of measuring beryllium (Be), Lilly has developed a default value for 

beryllium emissions. Fortunately, beryllium is a scarce element that is not used in Lilly pharmaceutical 

manufacturing processes. Lilly has examined all its manufacturing processes and associated process 

construction materials (e.g. alloy steels) and found no indication that beryllium should be present.

Therefore, Lilly believes that a conservatively calculated default value for beryllium is technically

defensible. 

Trace levels of beryllium are possible in raw materials and ground water. Lilly has sampled its liquid 

waste and found only sporadic “hits” of beryllium at levels close to the detection limits. Lilly has also done 

some limited sampling of plant trash, some of which might be processed in the solid-liquid incinerator, 

and some low-levels of beryllium were reported. For the purposes of calculating a conservative default

emission concentration, Lilly has assumed that all liquid and solid wastes fed to the solid-liquid incinerator 

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contain Be at the maximum levels detected: 1.0 ppm in the solid waste and 0.01ppm in the liquid wastes. 

The default emission concentration was then calculated using the maximum waste feed rates from the

CPT plan, and an LVM system removal efficiency (SRE) of 98% (which is a factor of two less than the

design SRE of 99% and a factor of 20 less than the SRE of 99.9% obtained during the CPT of another 

Lilly incinerator with a virtually identical scrubber system). The resulting value was just over 1 ug/dscm. 

To be more conservative, Lilly has chosen 2 ug/dscm as a default value. Therefore, a value of 2 ug/dscm

will be added to the measured LVM emission before comparison to the emission standard limit. If the 

CPT data or any other evidence indicates the default value is not appropriate, it will be adjusted 

accordingly. 

Copies of the XACT Multi-Metals CEMS Guidance Documents, Performance Specifications, and Quality 

Assurance Documents are provided in Appendix B. 

3.2.2.1.1 Sample Extraction System 

The extraction system for the XACT is identical to the extraction system used by the Sigrist PM CEMS.

The sample system consists of a sample probe and ring pipe. The sample probe size was selected by

the manufacturer to provide an inlet gas velocity that is approximately 1.0 to 1.5 times greater than the

normal stack gas velocity when sampling at the preset (design) rate of approximately 1 acm/min. This 

super-isokinetic operating condition is used to minimize particulate measurement error that can be

significant at sub-isokinetic conditions. The super-isokinetic condition is an alternative to continuous 

monitoring of the stack gas velocity and adjustment of the sampling rate in order to maintain isokinetic 

conditions. 

Stack gases are withdrawn through a fixed sample probe, transferred through a ring pipe where the gas is 

conditioned by heating to approximately 160 o

C (320 oF) to vaporize any water and acid droplets that may 

be present in the gas stream. A slipstream of the sample gas is extracted isokinetically from the main ring

pipe flow into a large diameter stilling chamber and through the flow control module. 

3.2.2.1.2 Sample Collection Module 

About one liter per minute (lpm) of the stack gas is isokinetically drawn from the stilling chamber through

a sampling tube, mixed with a reducing agent, and filtered through a filter tape for analysis. After 

sampling for approximately 15 minutes, the deposit spot is advanced about two inches where the metals

concentrations per sample deposit are measured by XRF while the next sample is being collected. 

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3.2.2.1.3 Metals Analysis Module 

The metals analysis module of the XACT consists of an energy dispersive multi-element XRF analyzer. 

This multi-element sensor consists of an X-ray tube and a lithium-drifted silicon energy dispersive X-ray 

detector, or equivalent. The energy of the characteristic X-rays provides the qualitative information to 

identify the elements present in the sample while the intensity of each analyte line (X-ray) provides the 

quantitative information to determine the mass of each element present in the deposit. The mass of each 

metal per sample deposit spot is reported to the data acquisition system for subsequent stack gas 

concentration calculations. 

3.2.2.1.4 Flow Control Module 

The filtered gas from the sample module is drawn through the gas conditioning component of the flow 

control module. These components remove moisture and corrosive gases from the stack gas allowing for 

volume measurements in dry standard cubic meters (dscm). The gas is then drawn through a two-way

solenoid valve, pressure transducer, and mass flow controller. Typically, the flow travels directly to a

manual leak check valve and vacuum pump but a flow QA loop is available for cross-checking flows 

against a second mass flow meter. After flowing through the vacuum pump, the sample gas is returned

to the stack. 

3.2.2.1.5 System Control Module 

The system control module consists of programmable logic control devices, firmware, power supplies, 

relays, fuses, etc. to control the temperatures, flows and mechanical aspects of the system. The status of 

these components is monitored by software and firmware associated with the PC module. 

3.2.2.1.6 PC Interface Module 

The PC module contains the overall system control, XRF analysis, and calculation software. This

software monitors the system operating parameters and presents a variety of status and flags when a

component is operating outside of defined control ranges. It also performs quantitative XRF metals

concentration calculations and combines the metals concentrations per sample deposit with the volume 

sampled per sample deposit data to calculate dry stack gas concentrations in micrograms per dscm. 

3.2.2.1.7 Data Acquisition System and Historian 

Metals concentrations, in micrograms per dscm, data status, quality assurance data, status flags, and 

system operational status/alarms are passed to a data acquisition system (DAS). The DAS performs the

data calculations for compliance. All data are saved in a historian. 

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3.2.2.2 Installation Location 

The XACT sample interface inlet will be installed at an accessible location downstream of the air pollution 

control equipment where the metals concentration of the XACT-extracted sample of stack aerosol will be

representative of the metals concentration (ug/m3

) in the effluent emitted from the stack. Specifically, the

monitor location will be at least: 

y 2 equivalent duct diameters downstream from the nearest control device, point of 

pollution generation or other point at which a change in the pollutant concentration or

emission rate may occur. 

y 2 equivalent duct diameters upstream from the effluent exhaust. 

The equivalent duct diameter is calculated as per 40 CFR Part 60, Appendix A, Method 1, Section 2.1. 

A representative sample of stack gas will be drawn from the stack at an approximate rate of one cubic 

meter per minute, immediately heated to a temperature above the dew point for most acids, and 

maintained at that temperature during transport through heat-traced and insulated stainless steel tubing

to an instrument shed housing the CEMS and other monitoring instruments. 

3.2.2.3 Installation 

The XACT CEMS will be installed per manufacturer’s recommendations. Once the system is installed, it 

will be commissioned for use. This exercise will verify the system is installed properly per the 

manufacturer’s specification. 

3.2.2.4 Instrument Span 

The operating range of the XACT CEMS will be established during the CEMS certification period. Lilly will 

verify that the operating range (zero to span) will encompass the response of the XACT CEMS for all

expected waste streams. The HWC MACT emission limits, for the three metal classes, will fall within this

measurement range. 

3.2.2.5 System Start-up (Initial Operation) 

The initial start-up of the XACT CEMS will be at Cooper Environmental Services. The XACT CEMS will

be operated, sampling room air, to shakedown the system. Once the system is operating without errors, 

the XACT CEMS will undergo a Factory Acceptance Test to verify that the system meets or exceeds the 

functional criteria. 

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3.2.2.5.1 Factory Acceptance Test 

The Factory Acceptance Test will be executed at Cooper Environmental Services. The objective of this 

testing is to ensure the XACT CEMS meets or exceeds the functional operating criteria. Results of the 

Factory Acceptance Test will be documented and include the following major components: 

1. Manual Check List 

2. National Institute of Standards and Technology (NIST) Traceable Thin Film Calibration 

3. XRF Energy Alignment Check 

4. Stability Check 

5. Blank Bias Check (zero drift check) 

6. XRF Instrument Drift Check (upscale drift check) 

7. Flow Rate Drift Check

8. MACT Metal Linearity Check 

9. MACT Metal Relative Accuracy Check

3.2.2.6 System Start-up (Field Installation) 

Once the XACT CEMS is installed, the system will undergo an installation qualification (IQ) to ensure the

system is installed to manufacturer’s recommendations and that the system meets all safety 

requirements. Following successful IQ, the system will operate, sampling ambient air, for several weeks. 

Once the XACT CEMS has operated for several weeks without significant issues, Lilly will (1) Calibrate

(or check calibration) the XRF (2) Begin routine daily QA/QC (3) Begin daily system check for appropriate 

operation. The XACT CEMS will operate continuously in this mode (at least four weeks) prior to the

performance specification test. 

3.2.2.6.1 NIST Traceable Thin Film Calibration

During the initial start-up of the XACT CEMS, the XRF will be calibrated using NIST traceable thin film

standards. This calibration will establish calibration factors for each of the metals to be analyzed. The 

calibration factors are used to provide ug/spot quantitation for each metal analyzed. After the XACT

CEMS is installed at Lilly, the calibration factors will be checked by using thin film standards for up to five 

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different metals (at least one metal for each of the three metals classes). The XACT CEMS XRF will be 

re-calibrated if the relative percent difference is greater than 10% by using the following equation: 

CA Accuracy = *100

REF

CEMS REF

R

R − R

where: 

CA = X-ray fluorescence calibration accuracy

RCEMS = the value of the standard reported by the CEMS 

 RREF = the known value of the standard 

3.2.2.6.2 Routine Daily Quality Assurance and Quality Control 

The XACT CEMS conducts automatic precision checks with every sample run as well as daily upscale

and blank measurements (zero and upscale drift checks). These checks ensure that the XRF data is

precise; minimal blank bias is occurring, and significant instrument drift has not taken place. Specifically, 

the XACT CEMS will automatically (1) check energy alignment (2) check XRF stability (3) check zero drift 

(4) check upscale drift (5) check sample flow drift. 

3.2.2.6.3 Daily System Check 

Operations will manually perform a daily check of the XACT CEMS. The daily check will be documented. 

3.2.2.7 Performance Specification Test 

Once the XACT CEMS installation and initial field operation have been achieved, a validation of the 

XACT CEMS will be performed with hazardous waste. Data collected during these tests will provide an 

initial validation of the XACT CEMS. This validation will allow the use of the XACT CEMS to demonstrate

continuous compliance with the HWC MACT metals emission limits. 

The performance specification test will be performed to determine the accuracy, bias, precision, stability,

and cycle time of the XACT CEMS. The following checks will be performed as part of the performance

specification test: 

Cycle Time: The XACT CEMS will adhere to Performance Specification YY (Specifications and Test 

Procedures for X-ray Fluorescence Based Multi-Metals Continuous Emission Monitoring Systems at 

Stationary Sources prepared by Cooper Environmental Services, LLC). Performance Specification YY is 

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provided in Appendix B. Pursuant to Section 1.2.1 of Performance Specification YY, the CEMS must 

have a cycle time that is less than one-third the period of the applicable standard. For this application,

the cycle time will not exceed fifteen minutes. 

Stratification Test: The stratification test, described in section 3.1.2.6, for PM CEMS, will be applied to 

meet this requirement for the XACT CEMS. 

X-ray Fluorescence Calibration Check: The XACT CEMS will adhere to Performance Specification YY 

when conducting the X-ray Fluorescence Calibration Check. Using NIST traceable standards, the XACTXRF is challenged three times for each metal measured. The error is calculated according to the following

equation: 

CA = *100

REF

CEMS REF

R

R − R

where: 

CA = X-ray fluorescence calibration accuracy

RCEMS = the value of the standard reported by the CEMS (ug) 

 RREF = the known value of the standard (ug)

The average error of the three measurements for each metal must be less than 10% of the calibration 

standard’s value for each metal. 

Stability: The 7-Day Calibration Drift Test: The XACT CEMS will adhere to Performance Specification YY

when conducting the 7-day Calibration Drift Test. The stability test will be performed prior to the accuracy

testing. The CEMS must meet the following specifications for each of the seven consecutive days,

without any adjustments or calibrations made to the CEMS: 

• zero drift: ≤20% (of the emission limit value) determined by the following equation: 

*100

Ci

Ri Ri

ZDi CEMS − REF =

 where: 

 ZDi = the zero drift of the ith element (%) 

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 RiCEMS = the measured CEMS response to the zero standard for the ith element 

 RiREF = the reference value of the ith element on the zero standard

Ci = the emission limit of the ith element. 

Lilly will consider the emission limit of the individual metals (Ci) to be equal to the HWC MACT limit for the

metal class. For example, the emission limit for lead will be considered to be 120 ug/dscm for the 

purposes of determining zero drift for the XACT. 

• upscale drift: ≤15% (of the reference value) determined by the following equation: 

 *100

REF

CEMS REF

Ri

Ri Ri

UDi − =

 where: 

UDi = the upscale drift of the ith element (%) 

 RiCEMS = the measured CEMS response to the upscale standard for the ith

element. 

 RiREF = the reference value of the ith element on the upscale standard 

• volume of flow drift: ≤ 20% (of instrument span) determined by the following

equation: 

*100

FS

V V

VD CEMSR − m =

 where: 

VD = Volume drift (%) 

VCEMSR = Sample gas volume or flow measured by the CEMS volume check 

measurement device. 

 Vm = Sample gas volume or flow reported by the multi-metals CEMS

FS = Full scale value of the CEMS volume or flow measurement 

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CEMS Accuracy: The XACT CEMS will adhere to Performance Specification YY when determining the

CEMS accuracy. The accuracy of the XACT CEMS is determined using one of the following four options 

and performance criteria: 

• Option A: Linearity test of the entire CEMS 

− slope: 0.85-1.15 

− r ≥ 0.90 

− intercept < 20% of emission limit for each metal 

• Option B: Linearity test of the XRF and sampling modules separately from the 

sample interface. This option will also include a Transport Efficiency Test. 

− slope: 0.85-1.15 

− r ≥ 0.90 

− intercept < 20% of emission limit for each metal 

− Percent transport ≥90% or ≤110% 

• Option C: Relative bias of the entire CEMS 

− Relative % Bias ≤ 15% for each metal 

− % RSD ≤ 10% for each metal 

− r ≥ 0.90 for the metal used to demonstrate the 3-fold change 

• Option D: Relative bias of the XRF and sampling modules separately from the 

sample interface. This option will also include a Transport Efficiency Test. 

− Relative % Bias ≤ 15% for each metal 

− % RSD ≤ 10% for each metal 

− r ≥ 0.90 for the metal used to demonstrate the 3-fold change 

− Percent transport ≥90% or ≤110% 

3.2.2.8 Routine Operation of the Multi-Metals CEMS 

The quality assurance requirements will adhere to Procedure Z: Quality Assurance Requirements for Xray Fluorescence Based Multi-Metals Continuous Emission Monitoring Systems at Stationary Sources 

prepared by Cooper Environmental Services, LLC. Procedure Z is located in Appendix B. 

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3.2.2.8.1 Daily Quality Assurance Checks 

Each day, operations will manually perform a daily check of the XACT CEMS. Results will be 

documented. The XACT CEMS conducts automatic precision checks with every sample run as well as

daily upscale and blank measurements (zero drift, upscale drift, and volume (flow) checks). These checks 

ensure that the XRF data is precise; minimal blank bias is occurring, and significant instrument drift has 

not taken place. Specifically, the XACT CEMS will automatically (1) check energy alignment (2) check 

XRF stability (3) check zero drift (4) check upscale drift (5) check sample flow drift. For each daily check, 

the percent drift cannot exceed: 

• zero drift: 20% in terms of the emission limit 

• upscale drift: 15% in terms of the baseline value for each metal 

• volume flow: 20% in terms of instrument span 

3.2.2.8.2 Quarterly Audit 

3.2.2.8.2.1 First Quarterly Audit after Performance Specification Test 

The first quarterly audit after the performance specification test will consist of the CEMS accuracy test 

described in Section 3.2.2.7. 

XRF calibration factors will also be checked by performing an X-ray Fluorescence Calibration Audit. For 

each element measured, the percent difference must not exceed 10%. Each quarter, a sample volume

(flow) audit will be performed. The average of three volumes, taken at different measurement cycles,

must not exceed 10% of the reference value. The entire XACT CEMS and transport system will be

examined for problems, such as particulate build up. Appropriate preventative maintenance will be

performed on the CEMS. 

3.2.2.8.2.2 Subsequent Quarterly Audits 

Each quarter the XRF calibration factors will be checked by performing an X-ray Fluorescence Calibration 

Audit. For each element measured, the percent difference must not exceed 10%. Each quarter, a 

sample volume (flow) audit will be performed. The average of three volumes, taken at different 

measurement cycles, must not exceed 10% of the reference value. 

The entire XACT CEMS and transport system will be examined for problems, such as particulate build up. 

Appropriate preventative maintenance will be performed on the CEMS. 

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3.2.2.8.3 Annual Audit 

Annually, in addition to the quarterly checks, the XACT CEMS will be checked for accuracy (Performance

Specification YY). The accuracy will be determined using one of the four options and respective

performance criteria: 

• Option A: Linearity test of the entire CEMS 

− slope: 0.85-1.15 

− r ≥ 0.90 

− intercept < 20% of emission limit for each metal 

• Option B: Linearity test of the XRF and sampling modules separately from the 

sample interface. This option will also include a Transport Efficiency Test. 

− slope: 0.85-1.15 

− r ≥ 0.90 

− intercept < 20% of emission limit for each metal 

− Percent transport ≥90% or ≤110% 

• Option C: Relative bias of the entire CEMS 

− Relative % Bias ≤ 15% for each metal 

− % RSD ≤ 10% for each metal 

− r ≥ 0.90 for the metal used to demonstrate the 3-fold change 

• Option D: Relative bias of the XRF and sampling modules separately from the 

sample interface. This option will also include a Transport Efficiency Test. 

− Relative % Bias ≤ 15% for each metal 

− % RSD ≤ 10% for each metal 

− r ≥ 0.90 for the metal used to demonstrate the 3-fold change 

− Percent transport ≥90% or ≤110% 

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3.2.2.9 Component Replacement 

During normal operation of the XACT CEMS, specific components will need to be replaced. The XACT

CEMS standard operating procedures will address the criteria to be met upon replacement of significant 

components. 

3.2.2.10 Out of Control 

The out of control period will begin immediately after the last test run or check of an unsuccessful zero 

drift, upscale drift, sample flow drift, or unsuccessful accuracy audit. The out of control period ends 

immediately after the last test run or check of the subsequent successful audit or drift check, when the

PM CEMS is used as a back-up or when the incinerator enters parametric mode. When the incinerator is 

operating in parametric mode, the XACT CEMS will not be deemed out of control.

3.2.3 Use of the XACT Multi Metals CEMS to Demonstrate Compliance with the HWC MACT

Metals Standards 

Lilly may begin using the XACT CEMS to demonstrate continuous compliance with the HWC MACT 

metals emission standards only after the following is achieved: 

• A successful Performance Specification Test is performed following EPA’s approval of this

Alternative Monitoring Petition. 

• A modification to the Title V permit is approved that incorporates the requirements of the 

approved Alternative Monitoring Petition. 

Following completion of the above, on-going quality assurance will be performed on the XACT CEMS as

specified in Section 3.2.2.8 of this document. 

3.2.4 Monitoring Frequency and Averaging Time 

The multi-metals CEMS will monitor and record concentration values (μg/dscm) of mercury, low volatile

metals (arsenic and chromium; a default value will be incorporated for beryllium), and semivolatile metals

(lead and cadmium) at least once every 15 minutes. 

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The metals concentrations will be corrected to 7% oxygen by the following equation: 

21 2

21 7 *

O

M corr M uncorr −

− =

where: 

Mcorr= Mercury, semivolatile metals, or low volatile metals concentration corrected to 7% oxygen

 (μg/dscm) 

Muncorr= Mercury, semivolatile metals, or low volatile metals stack gas concentration (μg/dscm) 

 O2= Oxygen stack gas percent (vol % dry) 

An hourly block average will be calculated from the four 15 minute measurements during the hour as

shown in the following equation: 

4

4

1

∑= = i

Ci

HBA

where: 

HBA = Hourly block average value (ug/dscm) 

Ci = a fifteen minute observation from the CEMS analyzer (ug/dscm) 

The established beryllium default value will be added to the fifteen-minute chromium and arsenic CEMS

observations to calculate the LVM hourly block average. 

Valid results must be available for at least three of the 15-minute cycles of operation to calculate a onehour block average. 

Twelve-hour rolling averages will be calculated based on the average of the twelve most recent hourly

block averages as shown in the following equation: 

12

12

1

∑= = i

HBA

THRA

Where: 

THRA = Twelve hour rolling average value (ug/dscm) 

HBA = Hourly block average value (ug/dscm) 

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The twelve-hour rolling average will be updated every hour when a new hourly block average is

calculated. 

3.2.5 Block Average Calculations during Multi-Metals CEMS Daily Checks and Ongoing Quality

Assurance Checks 

The XACT CEMS will be off line up to one hour each day to perform the daily quality assurance checks. 

Block average calculations will be frozen during the daily upscale and zero checks. Lilly will continue to

burn hazardous waste during the daily quality assurance checks. Block average calculations will resume 

once the checks are performed. The twelve-hour rolling block average calculations will resume by adding

the first valid hour block average after the drift check to the previous 11-hour block average values. 

In addition, block average calculations will be frozen during the quarterly and annual audits. Rolling block 

average calculations will resume once these quality assurance checks are completed. 

3.2.6 Multi-Metals CEMS Backup 

In the event the multi-metals CEMS is not operating, Lilly will have the option to use the PM CEMS as a 

backup to the multi-metals CEMS under the following conditions: 

1. Results obtained from parallel operation of the two CEMS will be used to develop a technical

justification of how the PM CEMS provides reasonable assurance of compliance with the HWC 

MACT metals emission standard. 

2. When the multi-metals CEMS is not operating and the PM CEMS begins use as a backup, Lilly 

will use its best efforts to avoid introducing new waste streams (i.e. those that have not been 

historically burned while the two CEMS were in parallel operation) from the six “in-feed” 

conveyors to the final “merge” conveyor that leads to the kiln feed chute. 

In order to allow CEMS mode to establish waste streams that are not “new” during its initial

implementation period, the above restrictions on use of the PM CEMS serving as a backup for the multimetals CEMS will apply only after a sufficient time period has elapsed (not to exceed 6 months from the 

first CEMS mode operation) for Lilly to gain experience while processing a variety of existing solid waste

streams. Finally, Lilly will attempt to maintain nominally stable or historically lower feed rates of waste 

while the backup is being used, and will limit the use of the PM CEMS as a back up for the multi-metals

CEMS to 14 consecutive days per episode. 

Lilly will use its best efforts to minimize the time that the PM CEMS acts as a backup to the XACT CEMS.

To facilitate its efforts, Lilly will keep spare parts in stock and will maintain a service relationship with the

XACT CEMS manufacturer, or other qualified consultants. If both the PM CEMS and the multi-metals

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CEMS are not in use, Lilly will monitor operating parameter limits defined in Section 1209 of the HWC 

MACT (i.e. parametric operation). Details of the specific operating limits are provided in the Notification of

Compliance (NOC). 

Lilly will incorporate delays when transitioning from the CEMS mode of operation to the parametric mode 

of operation. Specifically, once the primary multi-metals CEMS and the backup PM CEMS are 

unavailable, the control system will automatically switch to the parametric mode of operation. Rolling

averages, related to the Air Pollution Control System (APCS), will not start until the system has been 

under the parametric mode of operation for 10 minutes. This 10-minute time period will allow Lilly time to 

make any adjustments to the APCS to bring the system to within the respective operating parameter

limits. In addition, up to four hours will be allowed before re-starting constituent feed rate rolling average 

operating parameter limits in order to clear the solid feed conveyor system. (Note that, in a similar 

fashion to the “backup” scenario described above, Lilly will use its best efforts to avoid introducing “new” 

waste streams from the six “in-feed” conveyors to the final “merge” conveyor that leads to the kiln feed 

chute during this four hour period. However, during initial CEMS mode operation periods there will be 

practical limitations to this criterion because few waste streams will have been burned.) Feed rates will 

be maintained nominally stable or historically lower than when operating in CEMS mode. If the CEMS 

mode of operation is still not available after four hours, the transition to parametric mode will be

completed and only waste with known composition will be processed in the incinerator so that constituent

feed rate operating parameter limits can be computed. 

3.3 HYDROGEN CHLORIDE (HCl) CEMS 

3.3.1 Indicator of Performance

The HCl CEMS is designed to continuously monitor the stack gas HCl concentration. Compliance with the

HCl/Cl2 HWC MACT emission standard will be demonstrated when the measured stack concentration of 

HCl combined with the default chlorine concentration is less than or equal to the applicable standard. 

Currently, Lilly must comply with the HCl/Cl2 HWC MACT interim standard of 21 ppmvd, corrected to 7

percent oxygen, specified under Section 63.1203(b) of the HWC MACT. Lilly will comply with the HWC 

MACT final HCl/Cl2 standard specified in Section 63.1219(a) no later than the date required by Section 

1206(a)(1)(ii) of the HWC MACT final replacement standards. The averaging time is over a 12-hour 

period, updated every minute. 

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3.3.2 Measurement Technique

3.3.2.1 Operating Principles 

The HCl CEMS is an Ecochem Multi-Component Infrared Analyzer (MC3), or equivalent, manufactured by

Ecochem Analytics. The MC3 monitors the stack gas sample for HCl concentrations. The MC3 also 

measures stack gas concentrations of carbon monoxide (CO), oxygen (O2), carbon dioxide (CO2), sulfur

dioxide (SO2) and nitrogen oxides (NOx). In addition, the MC3 measures the moisture content of the

stack gas. Figures 3 and 5 schematically illustrate the major components of the MC3, which include: 

1. Sample Extraction System

2. Pressure Regulation Module

3. Ecochem Multi-Component Infrared Analyzer 

4. System Controller 

5. Data Acquisition System and Historian 

3.3.2.1.1 Sample Extraction System 

The sample extraction system consists of two elements; a sample probe and a heated umbilical line. 

The heated sample probe is M&C Products Sample Drift Probe, or equivalent, manufactured by M&C 

Products. To provide accurate measurement of HCl, the sample extraction system, sample line and 

probe, provides a hot, wet sample to the MC3; eliminating the scrubbing of water-soluble compounds 

such as HCl and SO2. The M&C Products Sample Drift Probe provides the capability of sampling a water 

saturated gas stream, reducing the affect of water droplets at the sample point (first step in eliminating the 

water soluble aerosol). Operation of the sample probe (temperature, sample, purge, calibration modes) is

controlled by a Programmable Logic Controller (PLC); located in the MC3 sample cabinet. 

The sample umbilical line has the function of (1) providing calibration gas to the probe for daily zero and 

upscale span checks (2) providing calibration gas to the probe for linearity audits (3) providing a hot, wet 

sample to the MC3 analyzer. The sample umbilical is designed to operate at temperatures of 

approximately 180 °C; which is imperative for hot, wet sampling of HCl, moisture, and SO2. 

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3.3.2.1.2 Pressure Regulation Module 

The pressure regulation module is designed to remove both free particulates and water-soluble aerosols 

from the gas stream prior to analysis by the MC3 analyzers. The system also provides a sample gas to 

the MC3 at a constant pressure. Control of this system resides with the PLC in the MC3 cabinet. 

The pressure regulation module is designed to maintain a temperature of at least 180 Celsius, minimizing

scrubbing of HCl, moisture, and SO2. 

3.3.2.1.3 Ecochem Multi-Component Infrared Analyzer 

The sample extraction system delivers a hot, wet sample to the Ecochem Multi-Component infrared

Analyzer. The MC3 quantitates stack gas concentrations of CO, O2, CO2, SO2, NOx, H2O and HCl. HCl

analysis occurs by using single beam dual wavelength nondispersive infrared spectroscopy. The HCl gas

absorbs infrared radiation at a specific wavelength, which depends on its molecular structure. The

degree of absorption is proportional to the concentration of the target gas. Final values are reported by

the PLC in ppmv, dry units. 

Because the HCl/Cl2 HWC MACT emission limit is based on combined stack emissions of hydrogen

chloride and chlorine gas and the MC3 only measures hydrogen chloride, Lilly has developed a 

conservative default value for the chlorine concentration. Fortunately the amount of chlorine present in

stack gas from incinerators similar to the solid-liquid incinerator is typically very low, particularly if they

burn aqueous wastes and have wet air pollution control systems. Lilly has tested its incinerator in 

Mayaguez, Puerto Rico that is equipped with the same air pollution control system and burns similar 

liquid wastes as the solid-liquid incinerator. The results showed chlorine levels much less than 1 ppm 

(NOTE: During this testing, the bromine/chlorine and sulfur/chlorine waste composition ratios were below

levels that EPA believes could result in a negative measurement bias.) To be conservative, Lilly will use 

1 ppm as the default value for chlorine. Therefore, a value of 1 ppm will be added to the measured value 

of HCl before comparison to the HWC MACT emission standard. If the CPT data or any other evidence 

indicates the default value is not appropriate, it will be adjusted accordingly. 

3.3.2.1.4 System Controller 

A PLC provides control of the MC3, sample probe, pressure regulation module, and the sample interface. 

The PLC provides one minute averaged data, and validity status, for each analyte measured as well as

flow. The calibration and linearity procedures are also controlled by the PLC. All data, and status flags,

are sent to a data acquisition system for data formatting and compliance determination. 

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3.3.2.1.5 Data Acquisition System and Historian 

HCl concentrations in part per million corrected for moisture, data status, quality assurance data, status 

flags, and system operational status/alarms are passed to a data acquisition system (DAS) via modbus 

communication from the MC3 PLC. The DAS performs the data calculations for compliance. All data,

both system status and HCl concentrations, are saved in an historian. 

3.3.2.2 Installation Location 

The HCl CEMS extracts its sample from the flue gas stream in the stack. Section 3.1.1 of Performance 

Specification 2 provides guidance regarding appropriate monitor location. This measurement location is

at least: 

y 2 equivalent duct diameters downstream from the nearest control device, point of 

pollution generation or other point at which a change in the pollutant concentration or

emission rate may occur. 

y 0.5 equivalent duct diameters upstream from the effluent exhaust. 

3.3.2.3 Installation 

The MC3 system will be installed per manufacturer’s recommendations. Once the system is installed, it

will be commissioned for use. This exercise will verify the system is installed properly per the 

manufacturer’s specification. 

3.3.2.4 Instrument Span 

The span for the HCl CEMS is 100 ppmv. An instrument span which covers the expected peak levels will 

help to ensure that the 12-hour rolling average value correctly accounts for the short periods of more

concentrated emissions. Additionally, 100 ppmv HCl calibration gas is an HCl blending concentration

much preferred by vendors. Due to the high reactivity of HCl, it is difficult to ensure the continuing

accuracy of the calibration gas at lower concentrations. 

3.3.2.5 System Start-up (Initial Operation) 

3.3.2.5.1 Factory Acceptance Test 

The Factory Acceptance Test will be executed at Ecochem Analytics. The objective of this testing is to 

ensure the Ecochem CEMS meets or exceeds the functional operating criteria. Results of the Factory 

Acceptance Test will be documented and include the following major components: 

1. Sample Extraction System

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2. Pressure Regulation Module

3. System Configuration 

4. Ecochem Multi-Component Infrared Analyzer 

5. System Controller 

3.3.2.6 System Start-up (Field Installation) 

Once the Ecochem CEMS is installed, the system will undergo an installation qualification (IQ) to ensure 

the system is installed per the manufacturer recommendations. Following successful IQ of the MC3, the 

system will operate sampling ambient air for several weeks. During this time, MC3 operational issues will

be addressed. Once the MC3 system has operated for several weeks without significant issues, daily QA 

procedures will begin (zero and upscale drift checks, alarm monitoring, and completion of a daily system

check sheet). The MC3 system will operate in this mode until the incinerator is ready to treat waste. 

3.3.2.7 Performance Specification Test 

The certification of the Ecochem CEMS for HCl will follow the HCl CEMS Performance Specification

(attached as appendix C). Specifically, the following will be either tested or documented: 1) data recorder 

scale, 2) daily calibration drift, 3) installation and measurement location, 4) calibration drift test, 5) 

calibration error test, 6) system response time, 7) stratification test, and, 8) accuracy determination. Upon 

successful completion/verification of the above tests, the Ecochem CEMS can be used to show

continuous compliance the HWC MACT HCl/Cl2 emission standard. Each test is described below: 

3.3.2.7.1 Data Recorder Scale 

The range of the data recorder and the measurement range of the HCl CEMS will be documented. The 

daily zero and upscale calibration checks will fall within this range. The HCl CEMS will have a 

measurement range of 0-100 ppm HCl. 

3.3.2.7.2 Daily Calibration Drift 

The zero and upscale drift will be checked once daily. Zero gas (0 ppm HCl) will be used for the zero, 

and approximately 50 -100 ppmv HCl for the upscale. The calibration drift limit will be 5% of the

instrument span, or ± 5 ppmv. Zero and high-level calibration drifts shall be adjusted, at a minimum, 

whenever the 24-hour zero drift exceeds the limits of the calibration drift specification of ±5 ppmv. The

amount of excess zero and high-level drift measured at the 24-hour interval checks will be recorded. 

3.3.2.7.3 Installation and Measurement Location 

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The HCl CEMS extracts its sample from the flue gas stream in the stack. Section 8.1.2 of Performance 

Specification 2 provides guidance regarding appropriate monitor location. This measurement location is

at least: 

y 2 equivalent duct diameters downstream from the nearest control device, point of 

pollution generation or other point at which a change in the pollutant concentration or

emission rate may occur. 

y 0.5 equivalent duct diameters upstream from the effluent exhaust. 

3.3.2.7.4 Seven Day Calibration Drift Test

The procedure outlined in the HCl CEMS Performance Specification (attached as appendix C) will be 

used for this specification. The specification proposed for the calibration drift is 5 ppmv, which is 5% of

the instrument span. This is consistent with the expected drift for HCl monitoring using Fourier Transform 

Infrared Spectroscopy (FTIR) found in Performance Specification 15 (PS15), Section 10.1. It is also

consistent with Lilly’s experience with a similar monitoring system in Ireland, and with others’ experience 

in the U.S. The higher calibration drift for HCl monitoring as compared to that for NOx or SO2 monitoring

appears to be a result of the reactivity of HCl. The chemical’s high reactivity causes it to “stick” to the 

calibration cylinder walls, and to be extracted unevenly from the cylinder during the calibration process. 

Thus, it is the calibration gas itself that is causing variance in the calibration drift results, as well as

whatever drift the analyzer experiences. It is also worth noting that some other performance

specifications, such as PS 4 (for CO) do allow a calibration drift of up to 5% of span. 

3.3.2.7.5 Calibration Error Test 

The Calibration Error test will follow the procedures in the HCl CEMS Performance Specification 

(attached as appendix C). The Ecochem CEMS will be challenged three non-consecutive times with

zero, mid-level, and high-level certified gases. The cylinder gases will not be EPA Protocol 1 gases. The 

calibration gases will be injected into the sample system as close to the sampling probe outlet as practical 

and will pass through all CEMS components used during normal monitoring. The difference between the

instrument response and the reference value (certified gas) will be calculated after each injection and the 

resulting three differences will be averaged to determine the CE at each measurement point. The 

calibration error for each of the three levels will not exceed 5% of span. 

3.3.2.7.6 System Response Time 

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Using the Response Time Test procedure in the HCl CEMS Performance Specification (attached as 

appendix C), Lilly will determine a mean upscale and mean downscale system response time for the 

Ecochem (based upon CO). The slower of the upscale and downscale mean response times will be

considered the system response time. The system response time will meet the requirements specified in 

performance specification (i.e. 2 minutes). 

3.3.2.7.7 Interference Response Determination

The affect of other analytes upon the measurement of HCl will be documented (Ecochem calibration

table). 

3.3.2.7.8 Stratification Test 

The stratification of the gas stream will be determined using guidance in the HCl CEMS Performance 

Specification (attached as appendix C). Due to the low concentration of HCl expected in the gas stream, 

stratification will be documented in terms of velocity. A minimum of 12 sampling points will be used, with

6 sampling points along each of the two traverses. 

The value at each traverse point is then compared to the average value for all sampling points to

determine the percent stratification using the following equation: 

S = Ci −Cave *100% 

where: 

S = percent stratification 

 Ci

 = velocity at sampling point i 

 Cave = average velocity at all sampling points. 

If the percent stratification is less than or equal to 10 percent for any traverse point, the duct is not 

considered stratified at that location 

3.3.2.7.9 Accuracy Determination 

The accuracy of the HCl CEMS will be determined by performing either a Relative Accuracy

determination, or by dynamic spiking. 

3.3.2.7.9.1 Relative Accuracy Determination 

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The procedure outlined in the HCl CEMS Performance Specification (attached as appendix C) will be 

used as a guide for this specification. The RA of the CEMS must not be greater than 20% of the mean 

value of the reference method (RM) test data, or not greater than 10% in terms of the emission standard

(ppmv, dry), or have an absolute difference of less than 5 ppmv between the mean reference value and

the mean CEMS value. 

3.3.2.7.9.2 Dynamic Spiking 

Dynamically spiking may be used in lieu of a Relative Accuracy Test as a means to document the

accuracy, precision, and bias of the HCl CEMS. 

The dynamic spiking will follow the HCl Performance Specification (attached in Appendix C). Linear 

regression is used to establish the accuracy, precision, and bias of the HCl CEMS. The criteria for the

HCl dynamic spiking is (1) The correlation coefficient, r, must be greater than or equal to 0.90 (2) The

slope must be 1.0, +/- 0.15 (3) The Intercept must be equal to or less than 15% of the instrument span.

See Figure 6 for the Ecochem dynamic spiking overview. 

3.3.2.8 Routine Operation of HCl CEMS 

Ongoing quality assurance will follow the CMS operation and maintenance requirements in 40 CFR 

63.8(c) and the quality control program requirements under 40 CFR 63.8(d). In addition, Lilly will perform

daily calibration drift tests, quarterly calibration error audits (absolute calibration audit), and annual 

accuracy test audits as part of on-going quality assurance. 

3.3.2.8.1 Daily Calibration Drift 

The zero and upscale drift will be checked once daily. Zero gas (0 ppm HCl) will be used for the zero, 

and approximately 50 -100 ppmv HCl for the upscale. The calibration drift limit will be 5% of the

instrument span, or ± 5 ppmv. Zero and high-level calibration drifts shall be adjusted, at a minimum, 

whenever the 24-hour zero drift exceeds the limits of the calibration drift specification of ±5 ppmv. The

amount of excess zero and high-level drift measured at the 24-hour interval checks will be recorded. 

The HCl CEMS will be deemed out of control when either the zero or upscale drift exceeds 2x the 

performance specification. See Section 3.3.2.9. 

3.3.2.8.2 Quarterly Absolute Calibration Audit (Calibration Error Test) 

The Calibration Error test will follow the procedures in the HCl CEMS Performance Specification 

(attached as appendix C). The Ecochem CEMS will be challenged three non-consecutive times with

zero, mid-level, and high-level certified gases. The cylinder gases will be certified gases (EPA Protocol 1 

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gases are not available for HCl). The calibration gases will be injected into the sample system as close to 

the sampling probe outlet as practical and will pass through all CEMS components used during normal

monitoring. The difference between the instrument response and the reference value (certified gas) will 

be calculated after each injection and the resulting three differences will be averaged to determine the CE

at each measurement point. The calibration error for each of the three levels will not exceed 5% of span. 

An absolute calibration audit will be performed quarterly, except during the quarter the annual accuracy is 

performed. 

3.3.2.8.3 Annual Accuracy Test Audit 

The accuracy of the HCl CEMS will be determined by performing either a Relative Accuracy

determination, or by dynamic spiking. The location of the sample probe will be verified. 

3.3.2.8.3.1 Seven Day Drift Test

Prior to the start of the accuracy test (either the Relative Accuracy Determination or Dynamic Spiking) you 

must perform a calibration drift test for a period of at least seven days. The seven-day calibration drift test 

must be conducted when the facility is under normal operations. During the calibration drift test period you

must determine the magnitude of the zero calibration drift and the upscale calibration drift at least once

each day. During the stability tests no adjustments or calibrations may be made to the CEMS. If periodic 

automatic or manual adjustments are made to the CEMS zero and calibration settings, conduct the CD 

test immediately before these adjustments, or conduct it in such a way that the CD can be determined. 

The zero and upscale drift each must be less than 5% of the instrument span each day for seven

consecutive days. 

3.3.2.8.3.2 Relative Accuracy Determination 

The procedure outlined in the HCl CEMS Performance Specification (attached as appendix C) will be 

used as a guide for this specification. The RA of the CEMS must not be greater than 20% of the mean 

value of the reference method (RM) test data, or not greater than 10% in terms of the emission standard

(ppmv, dry), or have an absolute difference of less than 5 ppmv between the mean reference value and

the mean CEMS value. 

3.3.2.8.3.3 Dynamic Spiking 

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Dynamically spiking may be used in lieu of a Relative Accuracy Test as a means to document the

accuracy, precision, and bias of the HCl CEMS. 

The dynamic spiking will follow the HCl CEMS Performance Specification (attached in Appendix C).

Linear regression is used to establish the accuracy, precision, and bias of the HCl CEMS. The criteria for 

the HCl dynamic spiking are: (1) The correlation coefficient (r) must be greater than or equal to 0.90, (2) 

The slope must be 1.0, +/- 0.15, (3) The Intercept must be equal to or less than 15% of the instrument

span. See Figure 6 for the Ecochem dynamic spiking overview. 

3.3.2.9 Out Of Control 

Out of control determinations will follow 40 CFR 63.8(c)(7). Specifically, the HCl CEMS will be considered 

out of control if the zero (low-level) or high level calibration drift exceeds two times the applicable

calibration drift specification (i.e. the calibration drift is greater than ± 10 ppmv.) In addition, the HCl

CEMS will also be considered out of control if the CEMS fails the accuracy test audit or absolute

calibration audit. 

When the HCl CEMS is out of control, Lilly will take the necessary corrective action and shall repeat all

necessary tests which indicate that the system is out of control. Lilly will take corrective action and 

conduct retesting until the performance requirements are below the applicable limits. The beginning of 

the out of control period is the hour Lilly conducts a performance check that indicates an exceedance of

the performance requirements. The end of the out of control period will be the hour following the 

completion of corrective action and successful demonstration that the system is within the allowable

limits. When the incinerator is operating in parametric mode, the HCl CEMS will not be deemed out of 

control. 

3.3.3 Use of HCl CEMS for Demonstrating Continuous Compliance with the HCl/Cl2 HWC MACT

Emission Standard 

Lilly may begin using the Ecochem CEMS to demonstrate continuous compliance with the HWC MACT

HCl/Cl2 emission standard only after the following is achieved: 

• A successful Performance Specification Test is performed following EPA’s approval of this

Alternative Monitoring Petition. 

• A modification to the Title V permit is approved which establishes monitoring requirements based

on the results of the approved AMP. 

Following completion of the above, on-going quality assurance will be performed on the Ecochem CEMS

as specified in Section 3.3.2.8 of this document. 

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3.3.4 Monitoring Frequency and Averaging Time 

The Ecochem CEMS will monitor and record an HCl concentration at least once every 15 seconds. A 

one minute average will be calculated from the four 15 second measurements during the minute as

shown in the following equation: 

2

4

1

4

Cl

Ci

OMA i = +

∑=

where: 

OMA = HCl/ Cl2 one-minute average value (ppmvd) 

Ci = HCl fifteen second observation from the CEMS analyzer (ppmvd) 

 Cl2 = Chlorine gas default value (1 ppmvd), 

The twelve hour rolling average will be calculated based on the average of the 720 most recent valid oneminute averages as shown in the following equation: 

720

720

1

∑= = i

OMA

THRA

Where: 

THRA = Twelve hour rolling average value (ppmvd) 

OMA = One minute average value (ppmvd) 

The twelve hour rolling average will be updated every minute when a new one minute average is 

calculated. 

The HCl/Cl2 stack concentration will be corrected to 7% oxygen by the following equation: 

21 2

21 7 *

O

HCl HCl corr uncorr −

− =

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where: 

HClcorr = HCl/Cl2 concentration, expressed as HCl corrected to 7% oxygen (ppmvd) 

HCluncorr = HCl/Cl2 stack gas concentration, expressed as HCl (ppmvd) 

O2 = Oxygen stack gas percent (vol % dry) 

3.3.4.1 Rolling Average Calculations during HCl CEMS Daily Calibration and Ongoing Quality

Assurance Audits 

The Ecochem CEMS will be off-line for up to an hour, daily, to perform the daily quality assurance. 

Hazardous waste will continue to be burned while performing the zero and upscale drift checks for the

Ecochem CEMS (CO, O2, HCl). This is in lieu of the 20 minutes per day provided for in the appendix to

subpart EEE of part 63 (section 6.2 of the appendix). 

Rolling average calculations will be frozen while Lilly performs the daily span drift check and zero drift 

check while continuing to burn hazardous waste, unless a redundant HCl measurement system is

available. The rolling average calculations will be frozen for a period not to exceed one hour while 

burning hazardous waste for the daily calibration test. This hour includes the time needed to calibrate the

Ecochem system for all measured parameters (HCl, CO, O2, SO2, and NOx). Rolling average calculations

will resume once the span drift check and zero drift check have been performed. The twelve-hour rolling

average calculations will resume by adding the first valid one-minute average after the drift check to the

previous 719 one minute average values. 

In addition, rolling average calculations will also be frozen while the quarterly absolute calibration audit is

conducted. Rolling average calculations will resume once the tests have been completed. The one-hour 

rolling average calculations will resume by adding the first valid one-minute average to the previous 59 

one minute average values. The twelve-hour rolling average calculations will resume by adding the first 

valid one-minute average to the previous 719 one minute average values. 

3.3.4.2 Rolling Average Calculations during System Autopurge 

The Ecochem CEMS may be purged automatically once per day while hazardous waste is being burned.

Purging involves directing compressed air through the probe into the stack for a short period of time to

prevent buildup of solids in the probe. The purge period will last approximately 5 minutes. Purging the 

stack probe is necessary for preventive maintenance reasons and is recommended by the CEMS 

manufacturer due to the types of wastes burned in the solid liquid incineration system. 

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During the autopurge period, rolling average calculations for the pollutants monitored by the Ecochem 

system (HCl, CO, O2, SO2, and NOx) will be frozen (similar to when the system is in calibration mode). 

Once the autopurge period is complete and data is available (approximately 5 minutes), rolling average

calculations will be unfrozen. The approximate 5-minute time period when the Ecochem is offline due the 

autopurge should be considered excused downtime. 

3.3.4.3 PM and HWC MACT Metals Rolling Average Calculations during Ecochem CEMS Daily

Calibration and Ongoing Quality Assurance Audits

The stack moisture content measured by the Ecochem is used to calculate the dry stack flowrate. The 

dry stack flowrate is used to determine the rolling average value of the PM emission rate in terms of

mg/dscm. In addition, the PM CEMS and the Multi-Metals CEMS use the stack O2 concentration to 

correct measured stack data to 7% oxygen. Since both the stack moisture content and stack O2 

concentration will be unavailable when the Ecochem is being calibrated, when performing an ACA, or 

when the probe is being purged while burning hazardous waste, the rolling average calculations of the

HWC MACT metals and PM emission rates will be frozen during these periods. This is in addition to 

freezing the rolling average values of the constituents measured by the Ecochem CEMS (HCl, CO, O2, 

SO2, and NOx (See Section 3.3.4.1). Specifically, the rolling averages for the Multi-Metals and PM CEMS 

will be frozen once three consecutive 15-minute average values are unavailable in a one hour block 

average period due to calibration or ACA of the Ecochem, or autopurge of the Ecochem stack probe. In 

addition, Lilly will consider the time period the rolling averages are frozen as excused downtime. 

3.3.5 Backup to the HCl CEMS

Lilly will monitor operating parameter limits defined in Section 1209 of the HWC MACT when the

incinerator is in parametric mode. Details of the specific operating limits are provided in the NOC. 

Lilly will incorporate delays when transitioning from the CEMS mode of operation to the parametric mode 

of operation. Specifically, once the HCl CEMS is unavailable, the control system will automatically switch 

to the parametric mode of operation. Rolling averages, related to the Air Pollution Control System

(APCS), will not start until the system has been under the parametric mode of operation for 10 minutes. 

This 10-minute time period will allow Lilly time to make any adjustments to the APCS to bring the system

to within the respective operating parameter limits. In addition, up to four hours will be allowed before restarting constituent feed rate rolling average operating parameter limits in order to clear the solid feed

conveyor system. (Lilly will use its best efforts to avoid introducing “new” waste streams from the six “infeed” conveyors to the final “merge” conveyor that leads to the kiln feed chute during this four hour period. 

However, during initial CEMS mode operation periods there will be practical limitations to this criterion

because few waste streams will have been burned.) Feed rates will be maintained nominally stable or 

historically lower than when operating in CEMS mode. If the CEMS mode of operation is still not

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available after four hours, the transition to parametric mode will be completed and only waste with known

composition will be processed in the incinerator so that constituent feed rate operating parameter limits 

can be computed. 

3.4 JUSTIFICATION FOR REQUEST FOR ALTERNATIVE MONITORING METHOD 

The HWC MACT final rule (40 CFR 63 Subpart EEE) did not mandate the use of CEMS for parameters 

other than CO, hydrocarbon, oxygen, and particulate matter. (Use of a particulate matter CEMS is 

deferred until EPA promulgates PM CEMS performance specifications and operational requirements). 

However, as stated in the September 30, 1999 preamble to the HWC MACT, 64 Fed. Reg. 52925, the 

EPA has a strong preference for the use of CEMS for demonstration of compliance with emission 

standards. The regulatory preference for CEMS over the use of process operating limits is based on the 

CEMS direct measure of HAPs or surrogate HAPs in the stack gas, a high degree of certainty regarding 

compliance with the emission standards, and provision of better compliance information to the public.

The EPA therefore encourages units like Lilly’s to use CEMS in the manner proposed in this petition as 

an alternative to the HWC MACT mandated process parameter continuous monitoring of 40 CFR 

63.1209. This Alternative Monitoring Petition includes performance specifications and quality assurance 

requirements for each CEMS. 

The use of the PM, multi-metals and HCl CEMS is a significant investment that Lilly has voluntarily 

undertaken in order to receive certain regulatory incentives. Such regulatory incentives allowed to

facilities using alternative CEMS are outlined in the preamble to the September 30, 1999 final HWC 

MACT rule. The incentives include relief from the operating parameter limits prescribed in Section 1209

of the HWC MACT and relief from sampling and analyzing the waste feed streams for ash, mercury, SVM,

LVM, and HCl/Cl2. See Table 1 for the operating and emission limits that apply while the alternative

CEMS are operating. Providing incentives is a key factor for facilities voluntarily operating alternative 

CEMS and encourages the development and implementation of new and emerging CEMS. 

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4.0 ALTERNATIVE MONITORING CANDIDATES UNDER 63.1209(g) 

Lilly has prepared this section of the alternative monitoring petition under Section 63.1209(g) of the HWC 

MACT to request relief from certain operating parameter requirements. 

4.1 STACK GAS FLOWMETER DAILY CHECK AND AUTOPURGE

Section 6.2 of the Appendix to the HWC MACT allows facilities to burn hazardous waste for a maximum 

of 20 minutes while calibrating the CO and oxygen CEMS. No comparable provision exists in the HWC 

MACT rule for routine checks of parameter CMS that monitor operating data. However, the General 

Provisions allow such routine checks to occur during normal operation (40CFR part 63.8 (c)). Lilly will

perform daily routine checks of the stack gas flow meter while burning hazardous waste. 

In addition, the probe tip on the flowmeter monitoring the stack gas flow rate may be purged

approximately once per day while hazardous waste is being burned. Purging involves directing 

compressed air through the probe into the stack for a short period of time to prevent buildup of solids in

the probe. The purge period will last approximately 5 minutes. Purging the stack probe is necessary for 

preventive maintenance reasons and is recommended by the manufacturer due to the types of wastes

burned in the solid liquid incineration system. 

During the daily checks and auto purge periods, the stack gas flowrate rolling average calculations will be 

frozen. Once data is available, rolling average calculations will be unfrozen. Specifically, the first 

available one-minute average value following the autopurge period will be added to the most recent 59

one-minute average values prior to freezing the rolling average calculations. 

4.2 COMBUSTION GAS FLOW RATE OPERATING PARAMETER LIMIT 

The stack moisture content measured by the Ecochem is used to calculate the dry stack flowrate in terms 

of dscf/min. The dry stack flowrate hourly rolling average is compared to the HWC MACT maximum 

combustion gas flowrate limit. The stack moisture content will be unavailable when the Ecochem is being

calibrated, performing an ACA, or the Ecochem probe is being purged. Therefore, the rolling average 

calculations of the combustion gas flowrate will be frozen during these events. In addition, Lilly will

consider the time period the rolling average is frozen as excused downtime. 

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4.3 CALCULATION OF ROLLING AVERAGES WHEN ALL ONE-MINUTE AVERAGE VALUES 

ARE NOT AVAILABLE 

Lilly requests that the calculation of the one hour rolling average values be allowed to continue provided 

that 95% of the one-minute data values, in terms of the applicable limit, are available (i.e. 57 minutes for 

an hourly rolling average and 684 minutes for a 12-hour rolling average). Correspondingly, historical

storage of the data will be considered complete providing that 95% of the values have been captured. 

Purge and calibration times are excluded from the 95% calculation.

This request is based on response to a comment on the April 20, 2004 proposed HWC MACT rule.

Although, EPA was unable to make the change in the final HWC MACT rule signed September 14, 2005, 

the agency stated that it understands the need for such language and has recommended that sources 

use the provisions of 63.1209(g) to request this alternative monitoring approach. 

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5.0 ALTERNATIVE MONITORING PETITION APPROVAL 

Pursuant to Section 63.8(f)(5) of the General Provisions, the Administrator will provide notification of the

approval or intention to disapprove requests made under Section 63.8(f) of the General Provisions within

30 days of receipt of the application, and within 30 days after receipt of any supplementary information

that is submitted. Section 63.1209(g)(1)(iii)(C) states that the timing for approval of requests under 

§63.1209(g) is that the Administrator will provide notification of the approval or intention to disapprove the 

application within 90 days of receipt of the application, and within 60 days after receipt of any 

supplementary information that is submitted. 

However, Lilly would welcome comments at the agency’s earliest convenience since the alternative

monitoring issues identified in this application affect system design and instrument procurement activities,

test planning, control system configuration, and completion of MACT compliance plans.

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6.0 RELEVANT REFERENCES 

1. Performance Specification 11 – Specifications and Test Procedures for Particulate Matter 

Continuous Emission Monitoring Systems at Stationary Sources, 40 CFR Part 60, Appendix B, 

January 12, 2004. 

2. EPA Draft Guidance Documents on PM CEMS, provided to Eli Lilly and Company by EPA Office 

of Air Quality Planning and Standards March 3, 2005.

3. Procedure 2- Quality Assurance Requirements for Particulate Matter Continuous Emission

Monitoring Systems at Stationary Sources, 40 CFR Part 60, Appendix F, January 12, 2004. 

4. Draft Method 301 Evaluation of Candidate Conditional Methods, Cooper Environmental Services, 

LLC., Volume I, June 10, 2005 

• X-ray Based Filter Methods (XFM) 

• Multi-Metals Instrumental Analyzer Procedure (XACT-IAP) 

• Quantitative Reference Aerosol Generator (QAG) 

5. Draft Standard Operating Procedure for Generating a Quantitative Multi-metals Reference

Aerosol with the CES QAG, Cooper Environmental Services, LLC., Draft Method 301 Evaluation

of Candidate Conditional Methods Volume II, Appendix C, June 9, 2005 

6. Draft Performance Specification YY: Specifications and Test Procedures for X-ray Fluorescence

Based Multi-metals Continuous Emission Monitoring Systems at Stationary Sources, Cooper

Environmental Services, LLC., Draft Method 301 Evaluation of Candidate Conditional Methods,

Volume II, Appendix F, June 8, 2005 

7. Draft Procedure Z: Quality Assurance Requirements for X-ray Fluorescence Based Multi-metals 

Continuous Emission Monitoring Systems at Stationary Sources, Cooper Environmental Services, 

LLC., Draft Method 301 Evaluation of Candidate Conditional Methods, Volume II, Appendix F, 

June 9, 2005

8. Draft Determination of Metal Emissions from Stationary Sources Using Filters and Solid Sorbents 

with X-ray Fluorescence Analysis, Cooper Environmental Services, LLC., Draft Method 301

Evaluation of Candidate Conditional Methods, Volume II, Appendix B, June 10, 2005. 

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Lafayette, Indiana Alternative Monitoring Petition

9. Standard Operating Procedure for Generating a Quantitative Multi-Metals Reference Aerosol with

the CES QAG, Cooper Environmental Services, LLC., June, 2005. 

10. Performance Specification 2- Specifications and Test Procedures for SO2 and NOx Continuous 

Emission Monitoring Systems in Stationary Sources, 40 CFR 60 Appendix B, February 2000. 

11. Performance Specification 4A - Specifications and Test Procedures for Carbon Monoxide 

Continuous Emission Monitoring Systems in Stationary Sources, 40 CFR 60 Appendix B, 

February 2000. 

12. Performance Specification 4B - Specifications and Test Procedures for Carbon Monoxide and 

Oxygen Continuous Emission Monitoring Systems in Stationary Sources, 40 CFR 60 Appendix B, 

September 30, 1999. 

13. Appendix to Subpart EEE of Part 63 – Quality Assurance Procedures for Continuous Emissions 

Monitors Used for Hazardous Waste Combustors, 40 CFR 63 Subpart EEE, September 30, 1999. 

14. Performance Specification Z: Specifications and Test Procedures For Hydrogen Chloride (HCL) 

Continuous Emission Monitoring Systems At Stationary Sources, Eli Lilly, November 2005. 

15. Procedure DD: Quality Control and Quality Assurance Requirements for Hydrogen Chloride

(HCL) Continuous Emission Monitoring Systems At Stationary Sources, Eli Lilly, November 2005. 

58 Rev. 7.0