## I NDIANA 

## D EPARTMENT OF 

## E NVIRONMENTAL 

## M ANAGEMENT

We make Indiana a cleaner, healthier place to live.

Mitchell E. Daniels, Jr. 100 North Senate Avenue

Governor Indianapolis, Indiana 46204
(317) 232-8603 Thomas W. Easterly (800) 451-6027

Commissioner www.IN.gov/idem

Page 1 of 2

FNTV-PMOD.dot 03/23/06

Recycled Paper An Equal Opportunity Employer Please Recycle TO: Interested Parties / Applicant

DATE: March 20, 2007

RE: Eli Lilly / 157-22712-00006

FROM: Nisha Sizemore Chief, Permits Branch Office of Air Quality



## Notice of Decision: Approval – Effective Immediately

Please be advised that on behalf of the Commissioner of the Department of Environmental Management, I have issued a decision regarding the enclosed matter. Pursuant to IC 13-17-3-4 and 326 IAC 2, this permit modification is effective immediately, unless a petition for stay of effect iveness is filed and granted, and may be revoked or modified in accordance with the provisions of IC 13-15-7-1.

If you wish to challenge this decision, IC 4-21.5-3-7 an d IC 13-15-7-3 require that you file a petition for

administrative review. This petition may include a request for st ay of effectiveness and must be submitted to the Office Environmental Adjudication, 100 Nort h Senate Avenue, Government Center North, Room 1049, Indianapolis, IN 46204, within eighteen (18) days of the mailing of this notice . The filing of a petition for administrative review is complete on the ear liest of the following dates that apply to the filing: (1) the date the document is delivered to the Office of Environmental Adjudication (OEA); (2) the date of the postmark on the envelope contai ning the document, if the document is mailed to OEA by U.S. mail; or (3) The date on which the document is deposited with a private carrier, as shown by receipt issued by the carrier, if the document is sent to the OEA by private carrier.

The petition must include facts demonstrating that you are either the applicant, a person aggrieved or adversely affected by the decision or otherwise entitled to review by law. Please identify the permit, decision, or other order for which you seek review by permit number, name of the applicant, location, date of this notice and all of the following: (1) the name and address of the person making the request; (2) the interest of the person making the request; (3) identification of any persons repres ented by the person making the request; (4) the reasons, with particularity, for the request; (5) the issues, with particularity, proposed for considerations at any hearing; and (6) identification of the terms and conditions wh ich, in the judgment of the person making the request, would be appropriate in the case in question to satisfy the requirements of the law governing documents of the type issued by the Commissioner.Pursuant to 326 IAC 2-7-18(d), any person may petition the U.S. EPA to object to the issuance of a Title V operating permit or modification within sixty (60) days of the end of the forty-five (45) day EPA review period. Such an objection must be based only on issues that were raised with reasonable specificity during the public comment period, unless the petitioner demonstrates that it was impractible to raise such issues, or if the grounds for such objection arose after the comment period.

To petition the U.S. EPA to object to the iss uance of a Title V operating permit, contact:

U.S. Environmental Protection Agency

401 M Street Washington, D.C. 20406

If you have technical questions regarding the enclos ed documents, please contact the Office of Air Quality, Permits Branch at (317) 233-0178. Calle rs from within Indiana may call toll-free at 1-800-451- 6027, ext. 3-0178.

Enclosures
FNTV-PMOD.doc 03/23/06

## I NDIANA 

## D EPARTMENT OF 

## E NVIRONMENTAL 

## M ANAGEMENT

We make Indiana a cleaner, healthier place to live.

Mitchell E. Daniels, Jr. 100 North Senate Avenue

Governor Indianapolis, Indiana 46204-2251 (317) 232-8603 Thomas W. Easterly (800) 451-6027

Commissioner www.IN.gov/idem

Ms. Beth Brock March 20, 2007

Environmental Team Leader Eli Lilly and Company – Tippecanoe Laboratories 1650 Lilly Road Lafayette, Indiana 47909-9201

Re: 157-22717-00006 Significant Permit Modification to: Part 70 permit No.: T157-6879-00006

Dear Ms. Brock:

Eli Lilly and Company – Tippecanoe Laboratories, was issued Part 70 operating permit T157- 6879-00006 on February 27, 2004 for a stationary pharmaceutical manufacturing plant. Three (3) separate applications, which were combined into Significant Permit Modification 157-22717-00006 to modify the Part 70 permit were received on March 1, 2006, June 2, 2006; and September 18, 2006. Pursuant to the provisions of 326 IAC 2-7-12 a signific ant modification to this permit is hereby approved as described in the attached Technical Support Document.

The permit modification consists of incorporati ng the applicable requirements for boilers 6 and 7, an emergency generator and an emergency air compressor permitted in Significant Source Modification No. 157-21809-00006 issued on June 6, 2006; including the incorporation of an Alternative Monitoring Plan (AMP), approved by US EPA on January 27, 2006 in lieu of the existing Continuous Emission Monitoring Systems (CEMS) for the T149 rotary kiln incinerator.

Please find a copy of the revised Part 70 permit.

This decision is subject to the Indiana Administra tive Orders and Procedures Act - IC 4-21.5-3-5. If you have any questions on this matter, pleas e contact Aida De Guzman OAQ, 100 North Senate Avenue, Indianapolis, Indiana, 46204-2251, or call at (800) 451-6027, and ask for Aida De Guzman or extension (3-4972), or dial (317) 233-4972.

Sincerely,

Original Signed By: Nisha Sizemore, Chief

Permits Branch Office of Air Quality

Attachments

APD



### cc: File -Tippecanoe County Tippecanoe County Health Department Air Compliance Section Inspector – Wanda Stanfield Compliance Data Section Administrative and Development

## I NDIANA 

## D EPARTMENT OF 

## E NVIRONMENTAL 

## M ANAGEMENT

We make Indiana a cleaner, healthier place to live.

Mitchell E. Daniels, Jr. 100 North Senate Avenue

Governor Indianapolis, Indiana 46204
(317) 232-8603 Thomas W. Easterly (800) 451-6027

Commissioner www.IN.gov/idem INDIANA DEPARTMENT OF ENVIRONMENTAL MANAGEMENT



# PART 70 OPERATING PERMIT AND

FLEXIBLE PERMIT AND PLANTWIDE APPLICABILITY LIMITATIONS (PAL) Permit

OFFICE OF AIR QUALITY

Eli Lilly and Company Tippecanoe Laboratories Facility 1650 Lilly Road Lafayette, Indiana 47909

(herein known as the Permittee) is he reby authorized to operate subject to the conditions contained herein, the source described in Section A (Source Summary) of this permit.

The Permittee must comply with all conditions of this pe rmit. Noncompliance with any provisions of this permit is grounds for enforcement action; permit termination, revocation and reissuance, or modification; or denial of a permit renewal application. Noncompliance with any provis ion of this permit, except any provision specifically designated as not federally enforceable, constitutes a viol ation of the Clean Air Act. It shall not be a defense for

the Permittee in an enforcement action that it would have been necessary to halt or reduce the permitted activity in order to maintain compliance with the conditions of this permit. An emergency does constitute an affirmative defense in an enforcement action provided the Permitt ee complies with the applicable requirements set forth in Section B, Emergency Provisions.

This permit is issued in accordance with 326 IAC 2 an d 40 CFR Part 70 Appendix A and contains the conditions and provisions specified in 326 IAC 2-7 as required by 42 U.S.C. 7401, et. seq. (Clean Air Act as amended by the 1990 Clean Air Act Amendments), 40 CFR Part 70.6, IC 13-15 and IC 13-17. This permit also addresses certain new source review requirements for existing equipm ent and is intended to fulfill the new source review procedures pursuant to 326 IAC 2-2 and 326 IA C 2-7-10.5, applicable to those conditions.

Operation Permit No.: T157-6879-00006

Issued by: Original signed by Janet G. McCabe, Assistant Commissioner Office of Air Quality Issuance Date: February 27, 2004

Expiration Date: February 27, 2009

First Significant Permit Modification No: 157-20216-00006, issued on January 19, 2005 First Administrative Amendment No: 157-20003-00006, issued on April 1, 2005 Second Administrative Amendment No: 157-21143-00006, issued on May 11, 2005 Second Significant Permit Modification No: 157-20732-00006, issued on August 15, 2005 Third Significant Permit Modification, Flexible Permit, and PAL Permit No. 157-21811-00006, issued on May 9, 2006

Fourth Significant Permit Modification No. 157-22717-00006

Issued by: Original Signed By:

Nisha Sizemore, Chief

Permits Branch Office of Air Quality Issuance Date: March 20, 2007

Expiration Date: February 27, 2009Eli Lilly and Company-Tippecanoe Labs 4 th Significant Permit Modifica tion No. 157-22717-00006 Page 2 of 226 Lafayette, Indiana Modified by: Aida De Guzman OP No. T157-6879-00006 Permit Reviewer: Dr. Trip Sinha

TABLE OF CONTENTS

A SOURCE SUMMARY ...................................................................................................................... 5 A.1 General Information [326 IAC 2-7-4( c)][326 IAC 2-7-5(15)][326 IAC 2-7-1(22)] A.2 Emission Units and Pollution Control Equipment Summary [326 IAC 2-7-4(c)(3)] [326 IAC 2-7-5(15)] A.3 Insignificant Activities [326 IAC 2-7- 1(21)][326 IAC 2-7-4(c) ] [326 IAC 2-7-5(15)] A.4 Part 70 Permit Applicability [326 IAC 2-7-2]

B GENERAL CONDITIONS .............................................................................................................. 11 B.1 Definitions [326 IAC 2-7-1] B.2 Permit Term [326 IAC 2-7-5(2)] [326 IAC 2- 1.1-9.5] [326 IAC 2-7-4( a)(1)(D)] [IC 13-15-3- 6(a)] B.3 Enforceability [326 IAC 2-7-7] B.4 Termination of Right to Operate [326 IAC 2-7-10] [326 IAC 2-7-4(a)] B.5 Severability [326 IAC 2-7-5(5)] B.6 Property Rights or Exclusive Privilege [326 IAC 2-7-5(6)(D)] B.7 Duty to Provide Inform ation [326 IAC 2-7-5(6)(E)] B.8 Certification [326 IAC 2-7-4(f)] [326 IAC 2-7-6(1)] [326 IAC 2-7-5(3)(C)] B.9 Annual Compliance Certific ation [326 IAC 2-7-6(5)]

B.10 Preventive Maintenance Plan [326 IAC 2-7-5(1), (3) and (13)] [326 IAC 2-7-6(1) and (6)] [326 IAC 1-6-3] B.11 Emergency Provisions [326 IAC 2-7-16] B.12 Permit Shield [326 IAC 2-7-15] [326 IAC 2-7-20] [326 IAC 2-7-12] B.13 Prior Permits Superse ded [326 IAC 2-1.1-9.5] B.14 Deviations from Permit Requirements and Conditions [326 IAC 2-7-5(3)(C)(ii)] B.15 Permit Modification, Reopening, Revocation and Reissuance, or Termination [326 IAC 2-7-5(6)(C)] [326 IA C 2-7-8(a)] [326 IAC 2-7-9] B.16 Permit Renewal [326 IAC 2-7-3] [326 IAC 2-7-4] [326 IAC 2-7-8(e)] B.17 Permit Amendment or Modification [326 IAC 2-7-11][326 IAC 2-7-12] B.18 Permit Revision Under Economic Incentives and Other Programs [326 IAC 2-7-5(8)] [326 IAC 2-7-12 (b)(2)] B.19 Operational Flexibility [326 IAC 2-7-20] [326 IAC 2-7-10.5] B.20 Source Modification Requ irement [326 IAC 2-7-10.5] B.21 Inspection and Entry [326 IAC 2-7-6] [IC 13-14-2-2][IC 13-30 -3-1] [IC 13-17-3-2] B.22 Transfer of Ownership or Oper ational Control [326 IAC 2-7-11] B.23 Annual Fee Payment [326 IAC 2-7-19] [326 IAC 2-7-5(7)][326 IAC 2-1.1-7] B.24 Advanced Source Modification Approval [326 IAC 2-7-5(16)] [326 IAC 2-7-10.5] B.25 Credible Evidence [326 IAC 2-7-5(3)] [ 326 IAC 2-7-6] [62 FR 8314] [326 IAC 1-1-6]

B.26 Term of Conditions [326 IAC 2-1.1-9.5]

C SOURCE OPERATION CONDITIONS .......................................................................................... 24

Emission Limitations and Sta ndards [326 IAC 2-7-5(1)]
C.1 Particulate Emission Limitations For Pr ocesses with Process Weight Rates Less Than One Hundred (100) pounds per hour [326 IAC 6-3-2] C.2 Opacity [326 IAC 5-1] C.3 Open Burning [326 IAC 4-1] [IC 13-17-9] C.4 Fugitive Dust Emissions [326 IAC 6-4]

C.5 Reserved C.6 Stack Height [326 IAC 1-7] C.7 Asbestos Abatement Projects [326 IAC 14-10] [326 IAC 18] [40 CFR 61, Subpart M]

Testing Requirements [326 IAC 2-7-6(1)] C.8 Performance Testing [326 IAC 3-6]

Compliance Requirements [326 IAC 2-1.1-11] C.9 Compliance Requirements [326 IAC 2-1.1-11]Eli Lilly and Company-Tippecanoe Labs 4 th Significant Permit Modifica tion No. 157-22717-00006 Page 3 of 226 Lafayette, Indiana Modified by: Aida De Guzman OP No. T157-6879-00006 Permit Reviewer: Dr. Trip Sinha

Compliance Monitoring Requirements [ 326 IAC 2-7-5(1)] [326 IAC 2-7-6(1)] C.10 Compliance Monitoring [326 IAC 2-7-5(3)] [326 IAC 2-7-6(1)]

C.11 Maintenance of Continuous Emission Monitoring Equipment [326 IAC 2-7-5(3)(A)(iii)] [326 IA C 2-1.1-11] [326 IAC 3-5]

Corrective Actions and Response Steps [326 IAC 2-7-5] [326 IAC 2-7-6] C.12 Emergency Reduction Plans [326 IAC 1-5-2] [326 IAC 1-5-3] C.13 Risk Management Plan [326 IAC 2-7-5(12)] [40 CFR 68] C.14 Compliance Response Plan - Preparation, Implementation, Records, and Reports [326 IAC 2-7-5] [326 IAC 2-7-6] C.15 Actions Related to Noncompliance Demonstrated by a Stack Test [326 IAC 2-7-5] [326 IAC 2-7-6]

Record Keeping and Reporting Requirements [326 IAC 2-7-5(3)] [326 IAC 2-7-19] C.16 Emission Statement [326 IAC 2-7-5(3)(C )(iii)] [326 IAC 2-7-5(7)] [326 IAC 2-7-19(c)] [326 IAC 2-6] C.17 General Record Keeping Requirements [326 IAC 2-7-5(3)] [326 IAC 2-7-6] [326 IAC 2-2] C.18 General Reporting Requirements [326 IAC 2-7-5(3)(C)] [326 IAC 2-1.1-11][326 IAC 2-2]

Stratospheric Ozone Protection C.19 Compliance with 40 CFR 82 and 326 IAC 22-1

D SOURCE OPERATION SECTIONS .............................................................................................. 34 D.1 Utilities Operations D.2 Utilities Support Operations

D.3 Fermented Products – Fermentation Operations D.4 Fermented Products – Purification Operations D.5 Fermented Products – Support Operations D.6 Bulk Pharmaceutical Manufacturing (BPM) Operations D.7 BPM Solvent Recovery Operations D.8 BPM Individual Drain System Operations D.9 BPM Solvent Storage Tanks D.10 BPM Waste Storage Tanks

D.11 BPM Waste Containers D.12 T49 Liquid Waste Incinerator Operations D.13 T149 Rotary Kiln Incinerator Operations D.14 Regenerative Thermal Oxidizer (RTO) System Operations D.15 T79 Fume Incinerator System Operations D.16 BPM Research and Development Operations D.17 BPM General Wastewater Requirements D.18 BPM Chemical Wastewater Treatment Plant Operations

D.19 BPM Transfer of Affected Wa stewater for Offsite Treatment D.20 Boilers 1 through 7, Emergency Generator, and Emergency Air Compressor

E SOURCE OPERATION SECTIONS ............................................................................................ 167 E.1 Leak Detection and Repair (LDAR) fo r BPM Process System Components E.2 Leak Detection and Repair (LDAR) for BPM Waste System Components

F SOURCE OPERATION SECTION .............................................................................................. 183 F.1 Change Management and Flexible Permit Conditions

G SOURCE OPERATION SECTION .............................................................................................. 199 G.1 Plantwide Applicability Limitations Requirements

Quarterly Coal Characteristic and Consumption Report .................................................................... 205 Quarterly Fuel Oil Characteristic and Consumption Report .............................................................. 206 Quarterly Generator Hours Report ........................................................................................................ 207 Streamlined CMS Periodic Report ..................................................................................................208-211Eli Lilly and Company-Tippecanoe Labs 4 th Significant Permit Modifica tion No. 157-22717-00006 Page 4 of 226 Lafayette, Indiana Modified by: Aida De Guzman OP No. T157-6879-00006 Permit Reviewer: Dr. Trip Sinha

Streamlined LDAR Periodic Report ................................................................................................212-213
Semi-Annual Boilers No. 6 and No. 7 Certification .................................................................214 Quarterly CO Emissions Report Boilers No. 6 and No. 7 ..........................................................215 Quarterly Fuel Oil Usage Report Boilers No. 6 ..................................................................216-217 Quarterly Fuel Oil Usage Report Boilers No. 7 ......................................................................218 Annual Hours of Operation Report Emergency Air Compressor .............................................219 Emergency Occurrence Report ......................................................................................................220- 221 Quarterly Deviation and Compliance Monitoring Report .................................................................... 222 Part 70 Operating Permit Ce rtification Quarterly Report .................................................................... 223
Section F.1 and Section G.1 – Quarterly Emission Limit Report ................................................224-226

The remainder of the page is left blank intentionally.Eli Lilly and Company-Tippecanoe Labs 4 th Significant Permit Modifica tion No. 157-22717-00006 Page 5 of 226 Lafayette, Indiana Modified by: Aida De Guzman OP No. T157-6879-00006 Permit Reviewer: Dr. Trip Sinha

SECTION A SOURCE SUMMARY

This permit is based on information requested by the Indiana Department of Environmental Management (IDEM), Office of Air Quality (OAQ). The informat ion describing the source contained in conditions A.1 through A.3 is descriptive information and does not constitute enforceable conditions. However, the Permittee should be aware that a physical change or a change in the method of operation that may render this descriptive information obsolete or inac curate may trigger requirements for the Permittee to obtain additional permits or seek modification of this permit pursuant to 326 IAC 2, or change other applicable requirements presented in the permit application.

A.1 General Information [326 IAC 2-7-4(c)] [326 IAC 2-7-5(15)] [326 IAC 2-7-1(22)]

The Permittee owns and operates a stationary pharmaceutical manufacturing plant.

Responsible Official: Mr. Lawrence J. McShane, General Manager Source Address: 1650 Lilly Ro ad, Lafayette, Indiana, 47909 Mailing Address: 1650 Lilly Road, Lafayette, Indiana, 47909 Source Phone Number: (765) 477-4226 SIC Code: 2833, 2879 County Location: Tippecanoe County

Source Location Status: Attainment for all criteria pollutants Source Status: Part 70 Permit Program; Major Source under PSD; Major Source, Section 112 of the Clean Air Act; 1 of 28 Source Categories

A.2 Emission Units and Pollution Control Equipment Summary [326 IAC 2-7-4(c)(3)] [326 IAC 2-7- 5(15)]

This stationary source consists of the follo wing emission units and pollution control devices:

(a) D.1 Utilities Operations : The utilities operations consist of three coal/natural gas-fired boilers equipped with an ash handling system and supported by a coal pile and coal conveyor system, and two natural gas boilers wi th fuel oil backup supplied by one fuel oil tank. The boilers provide steam to process operations in bulk pharmaceutical manufacturing and fermented products. The det ailed equipment list is located in Section D.1 of this permit. Section D. 1 will be superseded by Section D.20 starting September 13,

2007. This is the effective date of 40 CFR 63 Subpart DDDDD (Boiler MACT). At this time, the coal feed to Boilers No. 1, No. 2, and No. 3 will be shut off, and these boilers will burn 100% natural gas.

(b) D.2 Utilities Support Operations : The utility support facilities include the lime system for the potable water system (T9/T23), glycol tank s for heating and cooling of BPM tanks and chillers, generators and compressors. The det ailed equipment list is located in Section D.2 of this permit.

(c) D.3 Fermented Products - Fermentation Operations : The fermentation processes include the dry material storage area (T46), the raw material prep area (T1), the fermentation production areas (T2, T2A, T2B, T2C) and product storage area (T63). The detailed equipment list is located in Section D.3 of this permit.

(d) D.4 Fermented Products - Purification Operations : The whole broth products from fermentation are stored in Building T63 and then continuously fed to the purification equipment as capacity allows. The purificat ion department consists of extraction and elution processes (T3, T40, and T94), solvent recovery (T4), raw and recovered material storage (T147), and product storage (T39). The detailed equipment list is located in Section D.4 of this permit.Eli Lilly and Company-Tippecanoe Labs 4 th Significant Permit Modifica tion No. 157-22717-00006 Page 6 of 226 Lafayette, Indiana Modified by: Aida De Guzman OP No. T157-6879-00006 Permit Reviewer: Dr. Trip Sinha

(e) D.5 Fermented Products - Support Operations : The support operations for the Fermented Products (FP) area consist of t he FP wastewater treatment plant and FP wastewater sludge storage operat ions. The detailed equipment list is located in Section D.5 of this permit.

(f) D.6 Bulk Pharmaceutical Manufacturing (BPM) - Process Operations : The emission units in the BPM production operations can be genera lly described as process vessels (tanks), crystallizers, filters, centrifuges, dryers , process scrubber systems, and process condenser systems and are referred to as proc ess vents. The detailed equipment list is located in Section D.6 of this permit.

(g) D.7 BPM Support - Solvent Recovery Operations : The BPM solvent recovery emission units can be generally described as column s, stills, evaporators, accumulators and

receivers and are referred to as process vents. The detail ed equipment list is located in Section D.7 of this permit.

(h) D.8 BPM Individual Drain Systems (IDSs) : The BPM IDSs consist of stationary systems used to convey waste streams to a wa ste management unit. Segregated stormwater sewer systems, designed and operated for the so le purpose of collecting rainfall-runoff at a facility, and segregated from all other ID Ss, are excluded from this definition. The detailed equipment list is located in Section D.8 of this permit.

(i) D.9 BPM Support – Solvent Storage Tank Operations : The BPM solvent storage tanks are defined as any vessel designed to store ra w material feedstocks or used solvent to
be recovered that contain VOCs and/or VOH AP. Pressure vessels greater than 204.9 kPa without emissions to the atmosphere, vesse ls attached to motor vehicles, or vessels used to store beverage alcohol are not BPM solvent storage tanks. The detailed equipment list is located in Section D.9 of this permit.

(j) D.10 BPM Support – Waste Storage Tank Operations : The BPM waste storage tanks are defined as any waste management unit designed to contain an accumulation of waste material containing VOCs and/or VOH AP. Pressure vessels greater than 204.9 kPa without emissions to the atmosphere or vessels attached to motor vehicles are not BPM waste storage tanks. The detailed equipment list is located in Section D.10 of this permit.

(k) D.11 BPM Waste Containers : Waste containers are segregated into small and large containers. A small BPM waste container, su ch as a drum, contains VOC/VOHAP with a capacity greater than 26.4 gallons and equal to or less than 110.5 gallons. A large BPM waste container, such as a melon or a tanker truck, contains VOC/VOHAP with a capacity greater than 110.5 gallons. Identificati on of these types of containers have not been individually listed given they are portable and continually change.

(l) D.12 BPM Control Systems – T49 Liquid Waste Incinerator : The T49 liquid waste incinerator provides treatment of Lilly haz ardous and non-hazardous waste to support its operational requirements, including high Btu li quids (primary waste) and low Btu liquids (secondary waste). The T49 incinerator consists of a primary combustion chamber followed by a wet quench system, a condense r/absorber, a particulate matter scrubber, and a stack with continuous emissions monitoring. The detailed equipment list is located in Section D.12 of this permit.

(m) D.13 BPM Control Systems – T1 49 Solids-Liquid Waste Incinerator : The T149 solidsliquid waste incinerator provides treatment of Lilly hazardous and non-hazardous waste to support its operational requirements, in cluding containerized waste (hazardous and non-hazardous), high Btu liquids (primary waste) and low Btu liquids (secondary waste). The T149 incinerator consists of a rotary kiln and vertical up-fired secondary combustion chamber (SCC), a wet ash handling system, a NO

x abatement system, a wet quench system, a condenser/absorber, a particulate matter scrubber, an induced draft (ID) fan,Eli Lilly and Company-Tippecanoe Labs 4 th Significant Permit Modifica tion No. 157-22717-00006 Page 7 of 226 Lafayette, Indiana Modified by: Aida De Guzman OP No. T157-6879-00006 Permit Reviewer: Dr. Trip Sinha

and a stack with continuous emissions monitoring. The detailed equipment list is located in Section D.13 of this permit.

(n) D.14 BPM Control Systems – RTO Operations : The regenerative thermal oxidizer (RTO) system consists of a closed-vent syst em that transports fume streams exhausted from the BPM manufacturing and support operations to the RTOs. The RTOs, designed to thermally destruct the VOC and/or VOH AP laden fume streams from the process and support operations, are also equipped with caustic scrubbing systems to control hydrogen halide and halogen emissions. The det ailed equipment list is located in Section D.14 of this permit.

(o) D.15 BPM Control Systems – T79 Fume Incinerator Operations : The T79 fume incinerator system consists of a closed-v ent system that transports fume streams exhausted from the BPM manufacturing and supp ort operations to the T79 incinerator. The T79 incinerator, designed to thermally destruct the VOC and/or VOHAP laden fume streams from the process and support oper ations, are also equipped with caustic scrubbing systems to control hydrogen halide and halogen emissions. The detailed equipment list is located in Section D.15 of this permit.

(p) D.18 BPM – Chemical Wastewater Treatment Plant : The wastewater generated from the BPM operations is collected in wastewater holding tanks, transferred through a clarification process, followed by the biological treatment fa cility. The detailed equipment list is located in Section D.18 of this permit.

A.3 Insignificant Activities [326 IAC 2-7-1( 21)] [326 IAC 2-7-4(c)] [326 IAC 2-7-5(15)]

(a) This stationary source consists of the following insignificant activities, which are specifically regulated, as de fined in 326 IAC 2-7-1(21):

(1) D.3 Fermented Products - Fermentation Operations: Various mixers, bump tanks

and fermenter tanks in the fermentation operations each emitting less than 5 pounds PM10 per hour or 25 pounds PM10 per day. [326 IAC 6-3]

(2) D.8 BPM Individual Drain Systems (IDSs): Individual drain systems (sumps) in the BPM operating areas each emitting less than less than 3 pounds VOC per hour or 15 pounds VOC per day. [40 CFR 63.1256(e), 40 CFR 63.689(b), and 326 IAC 2-2]

(3) D.10 BPM Support – Waste Storage Tank Operations: Various BPM waste tanks and knock out pots in the BPM operating areas each emitting less than 3 pounds VOC per hour or 15 pounds VOC per day. [40 CFR 63.1256(b), 40 CFR 63.685, 40 CFR 60.110b, 326 IAC 2-2, and 326 IAC 8-5-3]

(4) D.11 BPM Waste Containers: Small and large waste containers in the BPM operating areas each emitting less than less than 3 pounds VOC per hour or 15 pounds VOC per day. [40 CFR 63.1256(d), 40 CFR 63.688, 326 IAC 2-2]

(5) D.6 BPM Production Operations: Heat exchange systems in the BPM operating areas are classified as insignificant activities under the closed loop heating and cooling system clause pursuant to 326 IAC 2-7-1(21)(FF). [40 CFR 63.1252(c)]

(6) D.16 Research and Development Operations : The T71 equipment components
from process piping systems, including pumps, valves, and piping connections [flanges] are classified as insignifican t activities under the research and development facility clause pursuant to 326 IAC 2-7-1(21)(E). [40 CFR 63.1255 and 40 CFR 61, Subpart V]

(b) This stationary source consists of the follo wing types of insignificant activities, as defined in 326 IAC 2-7-1 (21) that do not have applicable requirements:Eli Lilly and Company-Tippecanoe Labs 4 th Significant Permit Modifica tion No. 157-22717-00006 Page 8 of 226 Lafayette, Indiana Modified by: Aida De Guzman OP No. T157-6879-00006 Permit Reviewer: Dr. Trip Sinha

(1) Natural gas-fired combustion sources with heat input equal to or less than 10 MMBtu per hour;

(2) Propane or liquefied petroleum gas, or butane-fired combustion sources with heat input equal to or less than 6 MMBtu per hour;

(3) Equipment powered by internal combustion engines of capacity equal to or less than 0.5 MMBtu per hour, except where to tal capacity of equipment operated by one stationary source exceeds 2 MMBtu per hour;

(4) A gasoline fuel transfer and dispensing operation handling less than or equal to 1300 gallons per day, such as filling of t anks, locomotives, automobiles, having a storage capacity less than or equal to 10,500 gallons;

(5) A petroleum fuel, other than gasoline, dispensing facility, having a storage capacity of less than or equal to 10,500 gallons, and dispensing less than or equal to 230,000 gallons per month;

(6) VOC/HAP storage tanks with capacity less than or equal to 1,000 gallons and annual throughputs less than 12,000 gallons;

(7) VOC/HAP vessels storing lubricating oils, hydraulic oils, machining oils, and machining fluids;

(8) Refractory storage not requiring air pollution control equipment;

(9) Machining where an aqueous cutting coolant continuously floods the machining interface;

(10) Degreasing operations that do not exceed 145 gallons of solvent usage per 12 months, except if subject to 326 IAC 20-6;

(11) Cleaners and solvents having a vapor pressure equal to or less than 2kPa measured at 38°C or having a vapor pressure equal to or less than 0.7kPa measured at 20°C and not exceeding a combined usage rate of 145 gallons per 12 months;

(12) Closed loop heating and coo ling systems; [See Section D.2]

(13) Structural or fabrication cutting 200,00 0 linear feet or less of one inch plate or equivalent or using 80 tons or less of welding consumables;

(14) Activities associated with the treat ment of wastewater streams with an oil and grease content less than or equal to 1% by volume;

(15) Activities associated with the transportation and treatment of sanitary sewage, provided discharge to the treatment plant is under the control of the owner/operator, that is, an on-si te sewage treatment facility;

(16) Any operation using aqueous solutions containing less than 1% by weight of VOCs excluding HAPs;

(17) Forced and induced draft noncontact coo ling tower systems not regulated under a NESHAP;

(18) Replacement or repair of electrostatic precipitators, bags in baghouses and filters in other air filtration equipment;Eli Lilly and Company-Tippecanoe Labs 4 th Significant Permit Modifica tion No. 157-22717-00006 Page 9 of 226 Lafayette, Indiana Modified by: Aida De Guzman OP No. T157-6879-00006 Permit Reviewer: Dr. Trip Sinha

(19) Heat exchanger cleaning and repair;

(20) Process vessel degassing and cleaning to prepare for internal repairs;

(21) Stockpiled soils from soil remediation activities that are covered and waiting transport for disposal;

(22) Paved and unpaved roads and parking lots with public access;

(23) Covered conveyors for coal or coke co nveying of less than or equal to 360 tons per day; [See Section D.1]

(24) Coal bunker and coal scale exhaust s and associated dust collector vents;

(25) Asbestos abatement proj ects regulated by 326 IAC 14-10;

(26) Purging of gas lines and vessels that is related to routine maintenance and repair of buildings, structures, or vehicles at the source where air emissions from those activities would not be associated with any production process;

(27) Equipment used to collect any material that might be released during a malfunction, process upset, or spill cleanup, including catch tanks, temporary liquid separators, tanks and fluid handling equipment;

(28) Blowdown from sight glasses; boilers; compressors; pumps; and cooling towers;

(29) On-site fire and emergency response training approved by the department;

(30) Gasoline emergency generators not exceeding 110 horsepower;

(31) Diesel emergency generators not exce eding 1600 horsepower; [See Section D.2]

(32) Natural gas emergency turbines or reciprocating engines not exceeding 16,000 horsepower;

(33) Other emergency equipment such as stationary fire pumps; [See Section D.2]

(34) Grinding and machining operations contro lled with fabric filters, scrubbers, mist collectors, wet collectors and electrosta tic precipitators with a design grain loading of less than or equal to 0.03 grains per actual cubic foot and a gas flow rate less than or equal to 4000 actual cubic feet per minute, including deburring, buffing, polishing, abrasive blasting, pneumatic conveying, and woodworking operations;

(35) Purge double block and bleed valves;

(36) Filter or coalescer media changeout;

(37) Vents from ash transport systems not operated at positive pressures;

(38) A laboratory as defined in 326 IAC 2-7-1(21)(D);

(39) Research and development facility as defined in 326 AIC 2-7-1(E); [See Section D.21]

(40) Farm operations; and

(41) Other activities below insignificant threshold levels:Eli Lilly and Company-Tippecanoe Labs 4 th Significant Permit Modifica tion No. 157-22717-00006 Page 10 of 226 Lafayette, Indiana Modified by: Aida De Guzman OP No. T157-6879-00006 Permit Reviewer: Dr. Trip Sinha

(A) Portable cleaning and collection tanks less than 3 pounds VOC per hour or 15 pounds VOC per day;

(B) T4 sulfuric acid tank less than 5 pounds PM10 per day or 25 pounds PM10 per day;

(C) T47 trash transfer less than 5 pounds PM10 per day or 25 pounds PM10 per day;

(D) Sump tanks less than 3 pounds VOC per hour or 15 pounds VOC per day;

(E) T116 hydrochloric acid tank less than 5 pounds single HAP per day or 1 ton single HAP per year;

(F) T14 Ranney Well less than 5 pounds single HAP per day or 1 ton single HAP per year;

(G) T99 ethylene glycol expansion tanks/system less than 12.5 pounds combined HAP per day or 2.5 tons combined HAP per year;

(H) T100 MACE tanks/system less than 12.5 pounds per day or 2.5 tons combined HAP per year;

(I) T100 Unit 1 drumming operations less than 5 pounds PM10 per day or 25 pounds PM10 per day;

(J) T99/T100 solids particle sizing equipment (mills and delumpers) less than 5 pounds PM10 per day or 25 pounds PM10 per day; and

(K) Various fermentation and purificati on operations less than 3 pounds VOC per hour or 15 pounds VOC per day, less than 12.5 pounds per day or 2.5 tons combined HAP per year; and less than 5 pounds PM10 per day or 25 pounds PM10 per day. [See Section D.3 and D.4]

A.4 Part 70 Permit Applicability [326 IAC 2-7-2]

This stationary source is required to have a Part 70 permit by 326 IAC 2-7-2 (Applicability)

because:

(a) It is a major source, as defined in 326 IAC 2-7-1(22); and

(b) It is a source in a source category de signated by the United States Environmental Protection Agency (U.S. EPA) under 40 CFR 70.3 (Part 70 - Applicability).Eli Lilly and Company-Tippecanoe Labs 4 th Significant Permit Modifica tion No. 157-22717-00006 Page 11 of 226 Lafayette, Indiana Modified by: Aida De Guzman OP No. T157-6879-00006 Permit Reviewer: Dr. Trip Sinha

SECTION B GENERAL CONDITIONS

B.1 Definitions [326 IAC 2-7-1]

Terms in this permit shall have the definition assigned to such terms in the referenced regulation.

In the absence of definitions in the referenced regulation, the applicable definitions found in the statutes or regulations (IC 13-11, 326 IAC 1-2 and 326 IAC 2-7) shall prevail.

B.2 Permit Term [326 IAC 2-7-5(2)] [326 IAC 2-1.1- 9.5] [326 IAC 2-7-4(a)(1 )(D)] [IC 13-15-3-6(a)]

(a) This permit, T157-6879-00006, is issued fo r a fixed term of five (5) years from the issuance date of this permit, as determined in accordance with IC 4-21.5-3-5(f) and IC 13-15-5-3. Subsequent revisions, modificati ons, or amendments of this permit do not affect the expiration date of this permit.

(b) If IDEM, OAQ, upon receiving a timely and complete renewal permit application, fails to issue or deny the permit renewal prior to the expiration date of this permit, this existing permit shall not expire and all terms and conditions shall continue in effect, including any permit shield provided in 326 IAC 2-7-15 , until the renewal permit has been issued or

denied.

B.3 Enforceability [326 IAC 2-7-7]

Unless otherwise stated, all terms and conditions in this permit, including any provisions designed to limit the source's potential to emit, are enfor ceable by IDEM, the United States Environmental Protection Agency (U.S. EPA) and by citizens in accordance with the Clean Air Act.

B.4 Termination of Right to Operat e [326 IAC 2-7-10] [326 IAC 2-7-4(a)]

The Permittee's right to operate this source term inates with the expiration of this permit unless a timely and complete renewal application is submitt ed at least nine (9) months prior to the date of expiration of the source’s existing permit, cons istent with 326 IAC 2-7-3 and 326 IAC 2-7-4(a).

B.5 Severability [326 IAC 2-7-5(5)]

The provisions of this permit are severable; a determination that any portion of this permit is invalid shall not affect the validity of the remainder of the permit.

B.6 Property Rights or Exclusive Privilege [326 IAC 2-7-5(6)(D)]

This permit does not convey any property ri ghts of any sort or any exclusive privilege.

B.7 Duty to Provide Informat ion [326 IAC 2-7-5(6)(E)]

(a) The Permittee shall furnish to IDEM, OAQ, within a reasonable time, any information that IDEM, OAQ, may request in writing to dete rmine whether cause exists for modifying, revoking and reissuing, or terminating this permit, or to determine compliance with this permit. The submittal by the Permittee does require the certification by the “responsible official” as defined by 326 IAC 2-7-1(34). U pon request, the Permittee shall also furnish to IDEM, OAQ, copies of records required to be kept by this permit.

(b) For information furnished by the Permittee to IDEM, OAQ, the Permittee may include a claim of confidentiality in accordance with 326 IAC 17.1. When furnishing copies of requested records directly to U. S. EPA , the Permittee may assert a claim of confidentiality in accordance with 40 CFR 2, Subpart B.Eli Lilly and Company-Tippecanoe Labs 4 th Significant Permit Modifica tion No. 157-22717-00006 Page 12 of 226 Lafayette, Indiana Modified by: Aida De Guzman OP No. T157-6879-00006 Permit Reviewer: Dr. Trip Sinha

B.8 Certification [326 IAC 2-7-4(f)] [326 IAC 2-7-6(1)] [326 IAC 2-7-5(3)(C)]

(a) Where specifically designated by this permit or required by an applicable requirement, any application form, report, or compliance certification submitted shall contain certification by a responsible official of truth, accuracy, and completeness. This certification shall state that, based on info rmation and belief formed after reasonable inquiry, the statements and information in the document are true, accurate, and complete.

(b) One (1) certification shall be included, us ing the attached Certification Form, with each submittal requiring certification. One (1) ce rtification may cover multiple forms in one (1)

submittal.

(c) A responsible official is defined at 326 IAC 2-7-1(34).

B.9 Annual Compliance Certific ation [326 IAC 2-7-6(5)]

(a) The Permittee shall annually submit a co mpliance certification report which addresses the status of the source’s compliance with the terms and conditions contained in this permit, including emission limitations, sta ndards, or work practices. The initial certification shall cover the time period fr om the date of final permit issuance through December 31 of the same year. All subsequent certifications shall cover the time period from January 1 to December 31 of the previo us year, and shall be submitted in letter form no later than July 1 of each year to:

Indiana Department of Environmental Management Compliance Branch, Office of Air Quality

100 North Senate Avenue Indianapolis, Indiana 46204-2251

and

United States Environmental Protection Agency, Region V Air and Radiation Division, Air Enforcement Branch - Indiana (AE-17J)

77 West Jackson Boulevard Chicago, Illinois 60604-3590

(b) The annual compliance certification report re quired by this permit shall be considered timely if the date postmarked on the envelope or certified mail receipt, or affixed by the shipper on the private shipping receipt, is on or before the date it is due. If the document is submitted by any other means, it shall be considered timely if received by IDEM, OAQ,

on or before the date it is due.

(c) The annual compliance certification report shall include the following:

(1) The appropriate identification of each term or condition of this permit that is the basis of the certification;

(2) The compliance status;

(3) Whether compliance was continuous or intermittent;

(4) The methods used for determining the co mpliance status of the source, currently and over the reporting period consistent with 326 IAC 2-7-5(3); and

(5) Such other facts, as specified in Sect ions D of this permit, as IDEM, OAQ, may require to determine the compliance status of the source.Eli Lilly and Company-Tippecanoe Labs 4 th Significant Permit Modifica tion No. 157-22717-00006 Page 13 of 226 Lafayette, Indiana Modified by: Aida De Guzman OP No. T157-6879-00006 Permit Reviewer: Dr. Trip Sinha

The submittal by the Permittee does require t he certification by the “responsible official” as defined by 326 IAC 2-7-1(34).

B.10 Preventive Maintenance Plan [326 IAC 2-7-5( 1), (3) and (13)] [326 IAC 2-7-6(1) and (6)] [326 IAC 1-6-3]

(a) If required by specific condition(s) in Secti on D of this permit, the Permittee shall prepare

and maintain Preventive Maintenance Plans (PMPs) within ninety (90) days after issuance of this permit, including the following information on each facility:

(1) Identification of the individual(s) res ponsible for inspecting, maintaining, and repairing emission control devices;

(2) A description of the items or conditions that will be inspected and the inspection schedule for said items or conditions; and

(3) Identification and quantific ation of the replacement pa rts that will be maintained in inventory for quick replacement.

If, due to circumstances beyond the Permittee’s control, the PMPs cannot be prepared and maintained within the above timeframe, the Permittee may extend the date an additional ninety (90) days provided the Permittee notifies:

Indiana Department of Environmental Management Compliance Branch, Office of Air Quality

100 North Senate Avenue Indianapolis, Indiana 46204-2251

The PMP extension notification does not requi re the certification by the “responsible official” as defined by 326 IAC 2-7-1(34).

(b) The Permittee shall implement the PMPs, including any required record keeping, as necessary to ensure that failure to implement a PMP does not cause or contribute to an exceedance of any limitation on emissions or potential to emit.

(c) A copy of the PMPs shall be submitted to IDEM, OAQ, upon request and within a reasonable time, and shall be subject to review and approval by IDEM, OAQ. IDEM, OAQ may require the Permittee to revise its PMPs whenever lack of proper maintenance causes or is the primary contributor to an exceedance of any limitation on emissions or potential to emit. The PMP does not require t he certification by the “responsible official” as defined by 326 IAC 2-7-1(34).

(d) To the extent the Permittee is require d by 40 CFR Part 60/63 to have an Operation, Maintenance, and Monitoring (OMM) Plan for a unit, such Plan is deemed to satisfy the PMP requirements of 326 IAC 1-6-3 for that unit and, otherwise, such Plan is deemed to satisfy the applicable PMP requirements for that unit.

B.11 Emergency Provisions [326 IAC 2-7-16]

(a) An emergency, as defined in 326 IAC 2-7- 1(12), is not an affirmative defense for an action brought for noncompliance with a federal or state health-based emission limitation.

(b) An emergency, as defined in 326 IAC 2-7-1( 12), constitutes an affirmative defense to an action brought for noncompliance with a technology-based emission limitation if the affirmative defense of an emergency is demonstrated through properly signed, contemporaneous operating logs or other rele vant evidence that describe the following: (1) An emergency occurred and the Permitt ee can, to the extent possible, identify the causes of the emergency;Eli Lilly and Company-Tippecanoe Labs 4 th Significant Permit Modifica tion No. 157-22717-00006 Page 14 of 226 Lafayette, Indiana Modified by: Aida De Guzman OP No. T157-6879-00006 Permit Reviewer: Dr. Trip Sinha

(2) The permitted facility was at the time being properly operated;

(3) During the period of an emergency, the Permittee took all reasonable steps to

minimize levels of emissions that ex ceeded the emission standards or other requirements in this permit;

(4) For each emergency lasting one (1) hour or more, the Permittee notified IDEM, OAQ, within four (4) daytime business hours after the beginning of the emergency, or after the emergency was discovered or reasonably should have been discovered;

Telephone Number: 1-800-451-6027 (ask for Office of Air Quality, Compliance Section), or Telephone Number: 317-233-0178 (ask for Compliance Section)

Facsimile Number: 317-233-6865

(5) For each emergency lasting one (1) hour or more, the Permittee submitted the attached Emergency Occurrence Report Form or its equivalent, either by mail or

facsimile to:

Indiana Department of Environmental Management Compliance Branch, Office of Air Quality

100 North Senate Avenue Indianapolis, Indiana 46204-2251

within two (2) working days of the time when emission limitations were exceeded due to the emergency.

The notice fulfills the requirement of 326 IA C 2-7-5(3)(C)(ii) and must contain the following:

(A) A description of the emergency;

(B) Any steps taken to mitigate the emissions; and

(C) Corrective actions taken.

The notification, which shall be submitted by the Permittee, does not require the certification by the “responsible offi cial” as defined by 326 IAC 2-7-1(34).

(6) The Permittee immediately took all re asonable steps to correct the emergency.

(c) In any enforcement proceeding, the Permitt ee seeking to establish the occurrence of an emergency has the burden of proof.

(d) This emergency provision supersedes 326 IA C 1-6 (Malfunctions). This permit condition is in addition to any emergency or upset provision contained in any applicable requirement.

(e) IDEM, OAQ, may require that the Preven tive Maintenance Plans required under 326 IAC 2-7-4(c)(9) be revised in response to an emergency.

(f) Failure to notify IDEM, OAQ, by telephone or facsimile of an emergency lasting more than one (1) hour in accordance with (b)(4) and (5) of this condition shall constitute a violation of 326 IAC 2-7 and any other applicable rules.

(g) If the emergency situation causes a deviation from a technology-based limit, the Permittee may continue to operate the affect ed emitting facilities during the emergencyEli Lilly and Company-Tippecanoe Labs 4 th Significant Permit Modifica tion No. 157-22717-00006 Page 15 of 226 Lafayette, Indiana Modified by: Aida De Guzman OP No. T157-6879-00006 Permit Reviewer: Dr. Trip Sinha

provided the Permittee immediately takes a ll reasonable steps to correct the emergency

and minimize emissions.

(h) The Permittee shall include all emergencies in the Quarterly Deviation and Compliance Monitoring Report.

B.12 Permit Shield [326 IAC 2-7-15] [326 IAC 2-7-20] [326 IAC 2-7-12]

(a) Pursuant to 326 IAC 2-7-15, the Permittee has been granted a permit shield. The permit shield provides that compliance with the conditions of this permit shall be deemed compliance with any applicable requirements as of the date of permit issuance, provided that either the applicable requirements are in cluded and specifically identified in this permit or the permit contains an explicit determination or concise summary of a determination that other specifically iden tified requirements are not applicable. The
Indiana statutes from IC 13 and rules from 326 IAC, referenced in conditions in this permit, are those applicable at the time the permit was issued. The issuance or possession of this permit shall not alone constitute a defense against an alleged violation of any law, regulation or standard, except fo r the requirement to obtain a Part 70 permit under 326 IAC 2-7 or for applicable requirements for which a permit shield has been granted.

This permit shield does not extend to app licable requirements, which are promulgated after the date of issuance of this permit unless this permit has been modified to reflect such new requirements.

(b) In addition to the nonapplicability determinations set forth in Sections D of this permit, the IDEM, OAQ has made the following determination regarding this source:

(1) 40 CFR 60, Subpart D – Fossil-fuel fired steam generating units: This source is not subject to 40 CFR Part 60, Subpart D because none of the boilers at the plant site exceed 250 MMBtu/h r in heat input capacity. [40 CFR 60.40(a)(1)]

(2) 40 CFR 60, Subpart Db – Industrial-Commercial-Institutional steam generating units: This source is not subject to 40 CFR Part 60, Subpart Db because none of the boilers at plant site were constructed, reconstructed, or modified after June 19, 1984. [40 CFR 60.40b(a)]

(3) 40 CFR 60, Subpart Dc – Industria l-Commercial-Institutional steam generating units: This source is not subject to 40 CFR Part 60, Subpart Dc because none of the boilers at plant site were constructed, reconstructed, or modified after June 9, 1989. [40 CFR 60.40c(a)]

(4) 40 CFR 60, Subpart E – Incinerators: This source is not subject to 40 CFR Part 60, Subpart E because none of the incinerators at plant site exceed a charging rate of 50 metric tons per day. [40 CFR 60.50(a)]

(5) 40 CFR 60, Subparts Ec and CCCC – Hospital/Medical/Infectious waste

incinerators and Commercial-Industrial solid waste incinerators: This source is not subject to 40 CFR Part 60 Subpart Ec or Subpart CCCC because the combustors at the site are required to have a permit pursuant to Section 3005 of the Solid Waste Disposal Act. [40 CFR 60.50c(d) and 40 CFR 60.2020(g)]

(6) 40 CFR 60, Subparts VV, III, NNN and RR R – Synthetic organic chemical manufacturing: This source is not subject to 40 CFR Part 60, Subparts VV, III, NNN, and RRR because the source is not engaged in the manufacture of synthetic organic chemicals as defined by those standards. The source does not produce, as an intermediate, final produc t, co-product, or by-product, a chemicalEli Lilly and Company-Tippecanoe Labs 4 th Significant Permit Modifica tion No. 157-22717-00006 Page 16 of 226 Lafayette, Indiana Modified by: Aida De Guzman OP No. T157-6879-00006 Permit Reviewer: Dr. Trip Sinha

listed in 40 CFR 60.489 [Subpart VV ], 40 CFR 60.617 [Subpart III], 40 CFR 60.667 [Subpart NNN], or 40 CFR 60.707 [Subpart RRR].

(7) Section 111(d) Emission Guidelines: None of the emission guidelines in 40 CFR Part 60, 40 CFR Part 62, Subpart P, and 326 IAC 11 are applicable to this source because the source does not own or operate an affected facility subject to those requirements. 40 CFR Part 60, Subpart Ce and 326 IAC 11-6, and 40 CFR Part 60, Subpart DDDD and 326 IAC 11- 8 are not applicable to this source because combustors at the site are requi red to have a permit pursuant to Section 3005 of the Solid Waste Disposal Act. [40 CFR 60.32e(d) and 40 CFR 60.2555(g)]

(8) 40 CFR 61, Subpart C – Beryllium: This source is not subject to 40 CFR Part 61, Subpart C and 326 IAC 14-3 because t he incinerators at the source do not incinerate beryllium containing waste. [40 CFR 61.30(a) and 40 CFR 61.31(g)]

(9) 40 CFR 61, Subpart E – Mercury: This source is not subject to 40 CFR Part 61, Subpart E and 326 IAC 14-5, which applies to, among other things, incinerators burning wastewater treatment plant sludge because the source does not incinerate wastewater treatment pl ant sludge in its incinerators.

(10) 40 CFR 61, Subpart FF – Benzene Waste Operations: This source does not handle more than 10 megagrams of benze ne waste per year. Therefore the source is not subject to requirem ents of 40 CFR Part 61, Subpart FF.

(11) 40 CFR 63, Subparts F and G – Syntheti c Organic Chemical Manufacturing: This source is not subject to 40 CFR Part 63, Subparts F and G (326 IAC 20-10) because the source does not manufacture compounds listed in table 1 of Subpart F or use as a reactant compounds list ed in table 2 of Subpart F. [40 CFR 63.100(b)]

(12) 40 CFR 63, Subpart O – Ethylene Oxide Sterilizers: This source is not subject to 40 CFR Part 63, Subpart O and 326 IAC 20-5 because the source does not utilize ethylene oxide in steriliz ation operations. [40 CFR 63.360]

(13) 40 CFR 63, Subpart Q – Industrial Process Cooling Towers: This source is not subject to 40 CFR Part 63, Subpart Q and 326 IAC 20-4 because the source

does not utilize chromium based water treatment compounds in its cooling towers. [40 CFR 63.400]

(14) 40 CFR 63, Subpart T – Halogenated Solvent Cleaning: This source is not subject to 40 CFR Part 63, Subpart T and 326 IAC 20-6 because the source does not use halogenated solvents in any solvent cleaning machines. [40 CFR 63.460]

(15) 40 CFR 63, Subpart YY – Generic MACT categories: This source is not subject to 40 CFR Part 63, Subpart YY and 326 IA C 20-44 because the source is not one of the source categories describ ed in 40 CFR 63.1103. [40 CFR 63.1100]

(16) 40 CFR 63, Subpart MMM – Pesticide Active Ingredient Production: This source is not subject to 40 CFR Part 63, Subpart MMM and 326 IAC 20-45

because the source does not contain an y pesticide active ingredient process units or associated equipment as described in 40 CFR 63.1360. [40 CFR 63.1360]

(17) 326 IAC 6-5 – Fugitive Particulat e Matter Emission Limitations: This source does not have potential fugitive dust emissions greater than 25 tons per year, and is therefore, not subject to the requirements of this rule.Eli Lilly and Company-Tippecanoe Labs 4 th Significant Permit Modifica tion No. 157-22717-00006 Page 17 of 226 Lafayette, Indiana Modified by: Aida De Guzman OP No. T157-6879-00006 Permit Reviewer: Dr. Trip Sinha

(18) 326 IAC 8-3 – Organic Solvent Degreasing Operations: This source does not own or operate degreasing facilities contai ning organic solvent. Therefore, the requirements of 326 IAC 8-3-3/326 IAC 8-3-6 do not apply.

(19) 40 CFR 63, Subpart FFFF – Miscellaneous Organic Chemical Production and Processes: This source is not subjec t to 40 CFR Part 63, Subpart FFFF because

all the affected facilities at the source that would otherwise be subject to Subpart FFFF are subject to 40 CFR 63, Subpart GGG.

(20) 40 CFR 63, Subpart GGGGG – Site Remediation: This source is not subject to 40 CFR Part 63, Subpart GGGGG because t he site remediation activities at Tippecanoe Laboratories are being perfor med under a RCRA corrective action program at a treatment, storage and disposal facility.

(21) 326 IAC 8-4 – Petroleum Sources: This source does not operate any facilities subject to the requirements of 326 IAC 8- 4. 326 IAC 8-4-6 is not applicable to

this source because the source does not accept deliveries of gasoline by transports, as defined by 326 IAC 1-2-84.

(22) 326 IAC 8-6 – Organic Solv ent Emissions Limitations : The provisions of 326 IAC 8-6 are not applicable to this source because the source is subject to other
rules in 326 IAC 8.

(23) 326 IAC 10 – Nitrogen Oxide Rules: This source does not contain any
emission units identified in 326 IAC 10-4. T herefore, the source is not subject to the NOx emission control requirements of that rule.

(24) 326 IAC 11 – Emission Limitations for Specific Types of Operations: This source does not contain any emission unit s described in 326 IAC 11. Therefore, the source is not subject to t he requirements of those rules.

(25) 326 IAC 15 – Lead Rules: This source does not contain any emission units described in 326 IAC 15. Therefore, the source is not subject to the requirements of those rules.

(26) 326 IAC 21 – Acid Deposition: This source does not contain any emission units described in 326 IAC 21. Therefore, the source is not subject to the requirements of those rules.

(c) If, after issuance of this permit, it is deter mined that the permit is in nonconformance with an applicable requirement that applied to the source on the date of permit issuance, IDEM, OAQ, shall immediately take steps to reopen and revise this permit and issue a compliance order to the Permittee to ensure expeditious compliance with the applicable requirement until the permit is reissued. The per mit shield shall continue in effect so long as the Permittee is in compliance with the compliance order.

(d) No permit shield shall apply to any permit term or condition that is determined after issuance of this permit to have been bas ed on erroneous information supplied in the permit application. Erroneous information m eans information that the Permittee knew to be false, or in the exercise of reasonable ca re should have been known to be false, at the

time the information was submitted.

(e) Nothing in 326 IAC 2-7-15 or in this pe rmit shall alter or affect the following:

(1) The provisions of Section 303 of the Cl ean Air Act (emergency orders), including the authority of the U.S. EPA under Section 303 of the Clean Air Act;

(2) The liability of the Permittee for any vi olation of applicable requirements prior to or at the time of this permit's issuance;Eli Lilly and Company-Tippecanoe Labs 4 th Significant Permit Modifica tion No. 157-22717-00006 Page 18 of 226 Lafayette, Indiana Modified by: Aida De Guzman OP No. T157-6879-00006 Permit Reviewer: Dr. Trip Sinha

(3) The applicable requirements of the acid rain program, consistent with Section 408(a) of the Clean Air Act; and

(4) The ability of U.S. EPA to obtain inform ation from the Permittee under Section

114 of the Clean Air Act.

(f) This permit shield is not applicable to any change made under 326 IAC 2-7-20(b)(2) (Sections 502(b)(10) of the Clean Air Ac t changes) and 326 IAC 2-7-20(c)(2) (trading based on State Implementation Plan (SIP) provisions).

(g) This permit shield is not applicable to modifications eligible for group processing until after IDEM, OAQ has issued the modi fications. [326 IAC 2-7-12(c)(7)]

(h) This permit shield is not applicable to minor Part 70 permit modifi cations until after IDEM,
OAQ has issued the modificati on. [326 IAC 2-7-12(b)(8)]

B.13 Prior Permits Superse ded [326 IAC 2-1.1-9.5]

(a) Terms and conditions of previous permit s issued pursuant to permitting programs approved into the state implement ation plan have been either

(1) incorporated as originally stated,

(2) revised, or

(3) deleted

by this permit.

(b) All previous registrations and per mits are superseded by this permit.

B.14 Deviations from Permit Requirements and Conditions [326 IAC 2-7-5(3)(C)(ii)]

(a) Deviations from any permit requirements (for emergencies see Section B - Emergency Provisions), the probable caus e of such deviations, and any response steps or preventive measures taken shall be reported to:

Indiana Department of Environmental Management Compliance Data Section, Office of Air Quality

100 North Senate Avenue Indianapolis, Indiana 46204-2251

using the attached Quarterly Deviation and Compliance Monitoring Report, or its equivalent. A deviation required to be reported pursuant to an applicable requirement that exists independent of this permit, sha ll be reported according to the schedule stated in the applicable requirement and does not need to be included in this report.

The Quarterly Deviation and Compliance Monito ring Report does require the certification by the “responsible official” as defined by 326 IAC 2-7-1(34).

(b) A deviation is an exceedance of a permit limitation or a failure to comply with a requirement of the permit.Eli Lilly and Company-Tippecanoe Labs 4 th Significant Permit Modifica tion No. 157-22717-00006 Page 19 of 226 Lafayette, Indiana Modified by: Aida De Guzman OP No. T157-6879-00006 Permit Reviewer: Dr. Trip Sinha

B.15 Permit Modification, Reopening, Revocati on and Reissuance, or Termination [326 IAC 2-7- 5(6)(C)] [326 IAC 2-7-8(a)] [326 IAC 2-7-9]

(a) This permit may be modified, reopened, revok ed and reissued, or terminated for cause. The filing of a request by the Permittee for a Part 70 permit modification, revocation and reissuance, or termination, or of a not ification of planned changes or anticipated noncompliance does not stay any condition of this permit. [326 IAC 2-7-5(6)(C)] The notification by the Permittee doe s require the certification by the “responsible official” as defined by 326 IAC 2-7-1(34).

(b) This permit shall be reopened and revised und er any of the circumstances listed in IC 13- 15-7-2 or if IDEM, OAQ, determines any of the following:

(1) That this permit contains a material mistake.

(2) That inaccurate statements were made in establishing the emissions standards

or other terms or conditions.

(3) That this permit must be revised or revoked to assure compliance with an applicable requirement. [326 IAC 2-7-9(a)(3)]

(c) Proceedings by IDEM, OAQ to reopen and revise this permit shall follow the same procedures as apply to initial permit issuanc e and shall affect only those parts of this permit for which cause to reopen exists. Such reopening and revision shall be made as expeditiously as practicable. [326 IAC 2-7-9(b)]

(d) The reopening and revision of this permit, under 326 IAC 2-7-9(a), shall not be initiated before notice of such intent is provided to the Permittee by IDEM, OAQ, at least thirty (30) days in advance of the date this permi t is to be reopened, except that IDEM, OAQ may provide a shorter time period in the case of an emergency. [326 IAC 2-7-9(c)]

B.16 Permit Renewal [326 IAC 2-7-3] [326 IAC 2-7-4] [326 IAC 2-7-8(e)]

(a) The application for renewal shall be submitted using the application form or forms prescribed by IDEM, OAQ, and shall include the information specified in 326 IAC 2-7-4. Such information shall be included in the application for each emission unit at this source, except those emission units included on the triv ial or insignificant activities list contained in 326 IAC 2-7-1(21) and 326 IAC 2-7-1(40). The renewal application does require the certification by the “responsible offi cial” as defined by 326 IAC 2-7-1(34).

Request for renewal shall be submitted to:

Indiana Department of Environmental Management Permits Branch, Office of Air Quality 100 North Senate Avenue, Indianapolis, Indiana 46204-2251

(b) A timely renewal application is one that is: (1) Submitted at least nine (9) months prio r to the date of the expiration of this permit; and

(2) If the date postmarked on the envelope or certified mail receipt, or affixed by the shipper on the private shipping receipt, is on or before the date it is due. If the document is submitted by any other means , it shall be cons idered timely if received by IDEM, OAQ on or before the date it is due.

(c) If the Permittee submits a timely and complete application for renewal of this permit, the source’s failure to have a permit is not a violation of 326 IAC 2-7 until IDEM, OAQ, takesEli Lilly and Company-Tippecanoe Labs 4 th Significant Permit Modifica tion No. 157-22717-00006 Page 20 of 226 Lafayette, Indiana Modified by: Aida De Guzman OP No. T157-6879-00006 Permit Reviewer: Dr. Trip Sinha

final action on the renewal application, except that this protection shall cease to apply if, subsequent to the completeness determinati on, the Permittee fails to submit by the deadline specified in writing by IDEM, OAQ, any additional information identified as being needed to process the application.

B.17 Permit Amendment or Modification [326 IAC 2-7-11][326 IAC 2-7-12]

(a) Permit amendments and modifications are governed by the requirements of 326 IAC 2-7- 11 or 326 IAC 2-7-12 whenever the Permittee seeks to amend or modify this permit.

(b) Any application requesting an amendment or modification of this permit shall be

submitted to:

Indiana Department of Environmental Management Permits Branch, Office of Air Quality

100 North Senate Avenue Indianapolis, Indiana 46204-2251

Any such application shall be certified by the “responsible official” as defined by 326 IAC 2-7-1(34).

(c) The Permittee may implement administr ative amendment changes addressed in the request for an administrative amendment immediately upon submittal of the request. [326 IAC 2-7-11(c)(3)]

(d) No permit amendment or modification is required for the addition, operation or removal of a nonroad engine, as defined in 40 CFR 89.2.

B.18 Permit Revision Under Economic Incentives and Other Programs [326 IAC 2-7-5(8)] [326 IAC 2- 7-12(b)(2)]

(a) No Part 70 permit revision shall be required under any approved economic incentives, marketable Part 70 permits, emissions trading, and other similar programs or processes for changes that are provided for in a Part 70 permit.

(b) Notwithstanding 326 IAC 2-7-12(b)(1) and 326 IAC 2-7-12(c)(1), mi nor Part 70 permit modification procedures may be used for Part 70 modifications involving the use of economic incentives, marketable Part 70 permits, emissions trading, and other similar approaches to the extent that such minor Part 70 permit modification procedures are explicitly provided for in the applicable Stat e Implementation Plan (SIP) or in applicable requirements promulgated or approved by the U.S. EPA.

B.19 Operational Flexibility [326 IAC 2-7-20] [326 IAC 2-7-10.5]

(a) The Permittee may make any change or changes at the source that are described in 326 IAC 2-7-20(b), (c), or (e), without a prior per mit revision, if each of the following conditions

is met:

(1) The changes are not modifications under any provision of Title I of the Clean Air Act;

(2) Any preconstruction approval requir ed by 326 IAC 2-7-10.5 have been obtained;

(3) The changes do not result in emissions which exceed the limitations provided in this permit (whether expressed herein as a rate of emissions or in terms of total emissions);

(4) The Permittee notifies the:Eli Lilly and Company-Tippecanoe Labs 4 th Significant Permit Modifica tion No. 157-22717-00006 Page 21 of 226 Lafayette, Indiana Modified by: Aida De Guzman OP No. T157-6879-00006 Permit Reviewer: Dr. Trip Sinha

Indiana Department of Environmental Management Permits Branch, Office of Air Quality

100 North Senate Avenue Indianapolis, Indiana 46204-2251

and

United States Environmental Protection Agency, Region V Air and Radiation Division, Regulation Development Branch - Indiana (AR-18J)

77 West Jackson Boulevard Chicago, Illinois 60604-3590

in advance of the change by written notific ation at least ten (10) days in advance of the proposed change. The Permittee shall attach every such notice to the Permittee's copy of this permit; and

(5) The Permittee maintains records on-site, on a rolling five (5) year basis, which document all such changes and emission trades that are subject to 326 IAC 2-7- 20(b), (c), or (e). The Permittee shall make such records available, upon reasonable request, for public review.

Such records shall consist of all information required to be submitted to IDEM, OAQ, in the notices specified in 326 IAC 2-7-20(b)(1), (c)(1), and (e)(2).

(b) The Permittee may make Section 502(b)(10) of the Clean Air Act changes (this term is defined at 326 IAC 2-7-1(36)) without a permit revision, subject to the constraint of 326 IAC 2-7-20(a). For each such Section 502(b)(10) of the Clean Air Act change, the required written notification shall include the following:

(1) A brief description of the change within the source;

(2) The date on which the change will occur;

(3) Any change in emissions; and

(4) Any permit term or condition that is no longer applicable as a result of the change.

The notification, which shall be submitted, is not considered an application form, report or compliance certification. Therefore, the not ification by the Permittee does not require the certification by the “responsible offi cial” as defined by 326 IAC 2-7-1(34).

(c) Emission Trades [326 IAC 2-7-20(c)]

The Permittee may trade emissions increases and decreases at the source, where the applicable SIP provides for such emission trades without requiring a permit revision, subject to the constraints of Section (a) of this condition and those in 326 IAC 2-7-20(c).

(d) Alternative Operating Scenarios [326 IAC 2-7-20(d)]

The Permittee may make changes at the source within the range of alternative operating

scenarios that are described in the terms and co nditions of this permit in accordance with 326 IAC 2-7-5(9). No prior notification of IDEM, OAQ, or U.S. EPA is required.

(e) Backup fuel switches specifically addressed in, and limited under, Section D of this permit shall not be considered alternative operating scenarios. Therefore, the notification requirements of part (a) of this condition do not apply.Eli Lilly and Company-Tippecanoe Labs 4 th Significant Permit Modifica tion No. 157-22717-00006 Page 22 of 226 Lafayette, Indiana Modified by: Aida De Guzman OP No. T157-6879-00006 Permit Reviewer: Dr. Trip Sinha

B.20 Source Modification Requ irement [326 IAC 2-7-10.5]

A modification, construction, or reconstruction is governed by the require ments of 326 IAC 2, 326

IAC 2-7-10.5.

B.21 Inspection and Entry [326 IAC 2-7-6] [IC 13-14-2-2][IC 13-30 -3-1] [IC 13-17-3-2]

Upon presentation of proper identification card s, credentials, and other documents as may be required by law, and subject to the Permittee’s ri ght under all applicable laws and regulations to assert that the information collected by the age ncy is confidential and entitled to be treated as such, the Permittee shall allow IDEM, OAQ, U.S. EPA, or an authorized r epresentative to perform the following:

(a) Enter upon the Permittee's premises where a Part 70 source is located, or emissions related activity is conducted, or where reco rds must be kept under the conditions of this permit;

(b) As authorized by the Clean Air Act, IC 13- 14-2-2, IC 13-17-3-2, and IC 13-30-3-1, have access to and copy any records that must be kept under the conditions of this permit;

(c) As authorized by the Clean Air Act, IC 13-14 -2-2, IC 13-17-3-2, and IC 13-30-3-1, inspect any facilities, equipment (including monito ring and air pollution control equipment), practices, or operations regulated or required under this permit;

(d) As authorized by the Clean Air Act, IC 13-14 -2-2, IC 13-17-3-2, and IC 13-30-3-1, sample or monitor substances or para meters for the purpose of as suring compliance with this permit or applicable requirements; and

(e) As authorized by the Clean Air Act, IC 13- 14-2-2, IC 13-17-3-2, an d IC 13-30-3-1, utilize any photographic, recording, testing, monitori ng, or other equipment for the purpose of assuring compliance with this permit or applicable requirements.

B.22 Transfer of Ownership or Oper ational Control [326 IAC 2-7-11]

(a) The Permittee must comply with the requirements of 326 IA C 2-7-11 whenever the Permittee seeks to change the ownership or operational control of the source and no other change in the permit is necessary.

(b) Any application requesting a change in the ow nership or operational control of the source shall contain a written agreement containing a specific date for transfer of permit responsibility, coverage and liability betwe en the current and new Permittee. The application shall be submitted to:

Indiana Department of Environmental Management Permits Branch, Office of Air Quality

100 North Senate Avenue Indianapolis, Indiana 46204-2251

The application which shall be submitted by t he Permittee does require the certification by the "responsible official" as defined by 326 IAC 2-7-1(34).

(c) The Permittee may implement administr ative amendment changes addressed in the request for an administrative amendment immediately upon submittal of the request. [326 IAC 2-7-11(c)(3)]Eli Lilly and Company-Tippecanoe Labs 4 th Significant Permit Modifica tion No. 157-22717-00006 Page 23 of 226 Lafayette, Indiana Modified by: Aida De Guzman OP No. T157-6879-00006 Permit Reviewer: Dr. Trip Sinha

B.23 Annual Fee Payment [326 IAC 2-7-19] [326 IAC 2-7-5(7)] [326 IAC 2-1.1-7]

(a) The Permittee shall pay annual fees to IDEM, OAQ, within thirty (30) calendar days of receipt of a billing. Pursuant to 326 IAC 2-7-19 (b), if the Permittee does not receive a bill from IDEM, OAQ, the applicable fee is due April 1 of each year.

(b) Except as provided in 326 IAC 2-7-19(e), failure to pay may result in administrative enforcement action or revocation of this permit.

(c) The Permittee may call the following telephone numbers: 1-800-451-6027 or 317-233- 4230 (ask for OAQ, I/M & Billing Section), to determine the appropriate permit fee.

B.24 Advanced Source Modification Approval [326 IAC 2-7-5(16)] [326 IAC 2-7-10.5]

(a) The requirements to obtain a source modification approval under 326 IAC 2-7-10.5 or a permit modification under 326 IAC 2-7-12 are sa tisfied by this permit for the proposed emission units, control equipment or insignifi cant activities in Sections A.2 and A.3.

(b) Pursuant to 326 IAC 2-1.1-9 any permit authorizing construction may be revoked if construction of the emission unit has not commenced within eighteen (18) months from the date of issuance of the permit, or if duri ng the construction, work is suspended for a continuous period of one (1) year or more.

B.25 Credible Evidence [326 IAC 2-7-5(3)] [ 326 IAC 2-7-6] [62 FR 8314] [326 IAC 1-1-6]

For the purpose of submitting compliance certif ications or establishing whether or not the Permittee has violated or is in violation of any condition of this permit, nothing in this permit shall preclude the use, including the exclusive use, of any credible evidence or information relevant to whether the Permittee would have been in compli ance with the condition of this permit if the appropriate performance or compliance te st or procedure had been performed.

B.26 Term of Conditions [326 IAC 2-1.1-9.5]

Notwithstanding the permit term of a permit to construct, a permit to operate, or a permit modification, any condition established in a permit issued pursuant to a permitting program approved in the state implementation pl an shall remain in effect until:

(a) the condition is modified in a subsequent permit action; or

(b) the emissions unit to which the condit ion pertains permanently ceases operation.Eli Lilly and Company-Tippecanoe Labs 4 th Significant Permit Modifica tion No. 157-22717-00006 Page 24 of 226 Lafayette, Indiana Modified by: Aida De Guzman OP No. T157-6879-00006 Permit Reviewer: Dr. Trip Sinha

SECTION C SOURCE OPERATION CONDITIONS

Entire Source

Emission Limitations and Sta ndards [326 IAC 2-7-5(1)]

C.1 Particulate Emission Limitations For Proces ses with Process Weight Rates Less Than One Hundred (100) pounds per hour [326 IAC 6-3-2]

Pursuant to 326 IAC 6-3-2(e)(2), particulate em issions from any process not exempt under 326 IAC 6-3-1(b) or (c) which has a maximum process weight rate less than 100 pounds per hour and the methods in 326 IAC 6-3-2(b) through (d) do not apply shall not exceed 0.551 pounds per

hour.

C.2 Opacity [326 IAC 5-1]

Pursuant to 326 IAC 5-1-2 (Opacity Limitations), except as provided in 326 IAC 5-1-3 (Temporary Alternative Opacity Limitations), opacity shall meet the following, unless otherwise stated in this permit:

(a) Opacity shall not exceed an average of fo rty percent (40%) in any one (1) six (6) minute averaging period as determined in 326 IAC 5-1-4.

(b) Opacity shall not exceed sixty percent (60% ) for more than a cumulative total of fifteen (15) minutes (sixty (60) readings as measured according to 40 CFR 60, Appendix A, Method 9 or fifteen (15) one (1) minute nonoverlapping integrated averages for a continuous opacity monitor) in a six (6) hour period.

C.3 Open Burning [326 IAC 4-1] [IC 13-17-9]

The Permittee shall not open burn any material ex cept as provided in 326 IAC 4-1-3, 326 IAC 4- 1-4 or 326 IAC 4-1-6. The previous sentence notwithstanding, the Permittee may open burn in accordance with an open burning approval issued by the Commissioner under 326 IAC 4-1-4.1. 326 IAC 4-1-3 (a)(2)(A) and (B) are not federally enforceable.

C.4 Fugitive Dust Emissions [326 IAC 6-4]

The Permittee shall not allow fugitive dust to escape beyond the property line or boundaries of the property, right-of-way, or easement on which the source is located, in a manner that would violate 326 IAC 6-4 (Fugitive Dust Emissions). 326 IAC 6-4-2(4) is not federally enforceable.

C.5 Reserved

C.6 Stack Height [326 IAC 1-7]

The Permittee shall comply with the applicable provisions of 326 IAC 1-7 (Stack Height Provisions), for all exhaust stacks through which a potential (before controls) of twenty-five (25) tons per year or more of particulate matter or sulf ur dioxide is emitted. The provisions of 326 IAC 1-7-2, 326 IAC 1-7-3(c) and (d), 326 IAC 1-7-4( d), (e), and (f), and 326 IAC 1-7-5(d) are not federally enforceable.

C.7 Asbestos Abatement Projects [326 IAC 14-10] [326 IAC 18] [40 CFR 61, Subpart M]

The Permittee shall comply with the applicable requirements of 326 IAC 14-10, 326 IAC 18, and

40 CFR 61.140.Eli Lilly and Company-Tippecanoe Labs 4 th Significant Permit Modifica tion No. 157-22717-00006 Page 25 of 226 Lafayette, Indiana Modified by: Aida De Guzman OP No. T157-6879-00006 Permit Reviewer: Dr. Trip Sinha

The requirement in 326 IAC 14-10-1(a) that the owne r or operator shall use an Indiana Accredited Asbestos Inspector and all the requirements in 32 6 IAC 18 related to licensing requirements for asbestos inspectors are not federally enforceable.

Testing Requirements [326 IAC 2-7-6(1)]

C.8 Performance Testing [326 IAC 3-6]

(a) All testing shall be performed according to the provisions of 326 IAC 3-6 (Source Sampling Procedures), except as provided elsewhere in this permit, utilizing any applicable procedures and analysis methods specified in 40 CFR 51, 40 CFR 60, 40 CFR 61, 40 CFR 63, 40 CFR 75, or other procedures approved by IDEM, OAQ.

A test protocol, except as provided else where in this permit, shall be submitted to:

Indiana Department of Environmental Management Compliance Data Section, Office of Air Quality

100 North Senate Avenue Indianapolis, Indiana 46204-2251

no later than thirty-five (35) days prior to the intended test date. The protocol submitted by the Permittee does not require certification by the "respons ible official" as defined by 326 IAC 2-7-1(34).

(b) The Permittee shall notify IDEM, OAQ of the actual test date at least fourteen (14) days prior to the actual test date. The notificat ion submitted by the Permittee does not require certification by the "responsible offi cial" as defined by 326 IAC 2-7-1(34).

(c) Pursuant to 326 IAC 3-6-4(b), all test repo rts must be received by IDEM, OAQ not later than forty-five (45) days after the completion of the testing. An extension may be granted by IDEM, OAQ, if the source submits to IDEM, OAQ, a reasonable written explanation not later than five (5) days prior to the end of the initial forty-five (45) day period.

Compliance Requirements [326 IAC 2-1.1-11]

C.9 Compliance Requirements [326 IAC 2-1.1-11]

The commissioner may require stack testing, monitoring, or reporting at any time to assure compliance with all applicable requirements by issuing an order under 326 IAC 2-1.1-11. Any monitoring or testing shall be performed in acco rdance with 326 IAC 3 or other methods approved by the commissioner or the U. S. EPA.

Compliance Monitoring Requirements [ 326 IAC 2-7-5(1)] [326 IAC 2-7-6(1)]

C.10 Compliance Monitoring [326 IAC 2-7- 5(3)] [326 IAC 2-7-6(1)] [326 IAC 3-5]

(a) This section applies to the operation and maintenance of equipment and devices specified in Section D of this permit to deter mine or monitor compliance, except that it does not apply to continuous emissions monitoring systems or continuous opacity monitoring systems described in Section D. Section C.11 (Maintenance of Continuous Emission Monitoring Equipment) establishe s the general operation and maintenance requirements for continuous emission moni toring systems and continuous opacity monitoring systems.

(b) Unless otherwise specified in this permi t, all monitoring and record keeping requirements not already legally required shall be impl emented within ninety (90) days of permit issuance. If required by Section D, the Perm ittee shall be responsible for installing any necessary equipment and initiating any requir ed monitoring related to that equipment. IfEli Lilly and Company-Tippecanoe Labs 4 th Significant Permit Modifica tion No. 157-22717-00006 Page 26 of 226 Lafayette, Indiana Modified by: Aida De Guzman OP No. T157-6879-00006 Permit Reviewer: Dr. Trip Sinha

due to circumstances beyond its control, t hat equipment cannot be installed and operated within ninety (90) days, the Permittee may extend the compliance schedule related to the equipment for an additional ninety (90) days provided the Permittee notifies:

Indiana Department of Environmental Management Compliance Branch, Office of Air Quality

100 North Senate Avenue Indianapolis, Indiana 46204-2251

in writing, prior to the end of the initial ninety (90) day compliance schedule, with full justification of the re asons for the inability to meet this date.

The notification, which shall be submitted by the Permittee, does require the certification by the “responsible official” as defined by 326 IAC 2-7-1(34).

(c) Unless otherwise specified in the approval for the new emission unit(s), compliance monitoring for new emission units or emission units added through a source modification shall be implemented when operation begins.

(d) The Permittee shall keep records of mo nitoring system operation that include the following:

(1) All maintenance logs, calibration checks, and other required quality assurance

activities.

(2) All records of corrective and preventive action.

(3) A log of monitoring system dow ntime, including the following:

(A) Date of monito ring system downtime.

(B) Time of commencement and completion of each downtime.

(C) Reason for each downtime.

(e) The Permittee shall submit a report of monitoring system downtime as specified in Section D. The report shall include the following:

(1) Date of monitoring system downtime.

(2) Time of commencement.

(3) Duration of each downtime.

(4) Reasons for each downtime.

(5) Nature of system repairs and adjustments.

(f) Except where permit conditions streamline similar applicable requirements pursuant to 326 IAC 2-7-24, nothing in this permit nor in 326 IAC 3-5 supersedes the monitoring provisions in 40 CFR Part 60 or 40 CFR Part 63.

C.11 Maintenance of Continuous Emission Monitori ng Equipment [326 IAC 2-7-5(3)(A)(iii)] [326 IAC 2- 1.1-11] [326 IAC 3-5]

(a) Unless otherwise specified in this permi t, all monitoring and record keeping requirements not already legally required shall be impl emented within ninety (90) days of permit issuance. If required by Section D, the Perm ittee shall be responsible for installing any necessary equipment and initiating any requir ed monitoring related to that equipment. IfEli Lilly and Company-Tippecanoe Labs 4 th Significant Permit Modifica tion No. 157-22717-00006 Page 27 of 226 Lafayette, Indiana Modified by: Aida De Guzman OP No. T157-6879-00006 Permit Reviewer: Dr. Trip Sinha

due to circumstances beyond its control, t hat equipment cannot be installed and operated within ninety (90) days, the Permittee may extend the compliance schedule related to the equipment for an additional ninety (90) days provided the Permittee notifies:

Indiana Department of Environmental Management Compliance Branch, Office of Air Quality

100 North Senate Avenue Indianapolis, Indiana 46204-2251

in writing, prior to the end of the initial ninety (90) day compliance schedule, with full justification of the re asons for the inability to meet this date.

The notification, which shall be submitted by the Permittee, does require the certification by the “responsible official” as defined by 326 IAC 2-7-1(34).

(b) The Permittee shall install, calibrate, ma intain, and operate all necessary continuous emission monitoring systems (CEMS) and re lated equipment in accordance with applicable federal regulations and 326 IAC 3-5.

(c) This provision applies only to CEMS operat ed solely for monitoring compliance with BACT limitations. The CEMS shall be operated at all times as specified in Section D, except during CEMS malfunctions, reasonable periods of necessary CEMS calibration or

CEMS maintenance activities. CEMS calibra tion and maintenance activities shall be properly documented and shall be conduc ted pursuant to the standard operating procedures under 326 IAC 3-5-4(a).

(d) The Permittee shall keep records in accordance with 326 IAC 3-5-6(b) that includes the following:

(1) All documentation relating to:

(A) design, installation, and testing of all elements of the monitoring system;

and

(B) required corrective action or compliance plan activities.

(2) All maintenance logs, calibration checks, and other required quality assurance

activities.

(3) All records of corrective and preventive action.

(4) A log of plant operations, including the following:

(A) Date of facility downtime.

(B) Time of commencement and completion of each downtime.

(C) Reason for each downtime.

(e) In accordance with 326 IAC 3-5-7(5), the Permittee shall submit reports of continuous monitoring system instrument downtime, except for zero (0) and span checks, which shall be reported separately. The repo rts shall include the following:

(1) Date of downtime.

(2) Time of commencement.

(3) Duration of each downtime.Eli Lilly and Company-Tippecanoe Labs 4 th Significant Permit Modifica tion No. 157-22717-00006 Page 28 of 226 Lafayette, Indiana Modified by: Aida De Guzman OP No. T157-6879-00006 Permit Reviewer: Dr. Trip Sinha

(4) Reasons for each downtime.

(5) Nature of system repairs and adjustments.

(f) Except where permit conditions streamline similar applicable requirements pursuant to 326 IAC 2-7-24, nothing in this permit nor in 326 IAC 3-5 supersedes the monitoring provisions in 40 CFR Part 60 or 40 CFR Part 63.

(g) The permittee shall prepare and submit to IDEM, OAQ a written report of the results of the calibration gas audits and relative accuracy test audits for each calendar quarter within thirty (30) calendar days after the end of each quarter. The report must contain the information required by 326 IAC 3-5-5(e)(2 ). 326 IAC 3-5-5(e)(2) is not federally

enforceable.

Corrective Actions and Response Steps [326 IAC 2-7-5] [326 IAC 2-7-6]

C.12 Emergency Reduction Plans [ 326 IAC 1-5-2] [326 IAC 1-5-3]

Pursuant to 326 IAC 1-5-2 (Emergen cy Reduction Plans; Submission):

(a) The Permittee prepared and submitted wr itten emergency reduction plans (ERPs) consistent with safe operating procedures on December 13, 2000.

(b) Upon direct notification by IDEM, OAQ, that a specific air pollution episode level is in effect, the Permittee shall immediately put into effect the actions stipulated in the approved ERP for the appropriate epis ode level. [326 IAC 1-5-3]

C.13 Risk Management Plan [326 IAC 2-7-5(12)] [40 CFR 68]

If a regulated substance, as defined in 40 CFR 68, is present at a source in more than a threshold quantity, the source must comply with the applicable requirements of 40 CFR 68.

C.14 Compliance Response Plan - Preparation, Im plementation, Records, and Reports [326 IAC 2-7- 5] [326 IAC 2-7-6]

(a) Whenever a Testing and Monitoring condition establishes the requirement to implement a Compliance Response Plan (CRP), the Perm ittee shall prepare a CRP in conformance

with this condition. If a Permittee is re quired to have an Operation, Maintenance and Monitoring (OMM) Plan (or Parametric Monitoring Plan and Start-up, Shutdown, and Malfunction (SSM) Plan) under 40 CFR 60/63, such plans shall be deemed to satisfy the requirements for a CRP for those monitoring conditions. A CRP shall be submitted to IDEM upon request. The CRP shall be prepared wi thin ninety (90) days after issuance of this permit by the Permittee, supplemented from time to time by the Permittee, maintained on site, and comprised of:

(1) Reasonable response steps that may be implemented in the event that a response step is needed pursuant to the r equirements of Section D of this permit; and an expected timeframe for taking reasonable response steps.

(2) If, at any time, the Permittee takes re asonable response step s that are not set forth in the Permittee’s current Compliance Response Plan or Operation, Maintenance and Monitoring (OMM) Plan (or Parametric Monitoring Plan and Start-up, Shutdown, and Malfunction (SSM) Plan) and the Permittee documents such response in accordance with subsection (e) below, the Permittee shall amend its Compliance Response Plan or Operation, Maintenance and Monitoring (OMM) Plan (or Parametric Monitoring Plan and Start-up, Shutdown, and Malfunction (SSM) Plan) to include such response steps taken.Eli Lilly and Company-Tippecanoe Labs 4 th Significant Permit Modifica tion No. 157-22717-00006 Page 29 of 226 Lafayette, Indiana Modified by: Aida De Guzman OP No. T157-6879-00006 Permit Reviewer: Dr. Trip Sinha

The OMM Plan (or Parametric Monitoring and SMM Plan) shall be submitted within the time frames specified by the applicable 40 CFR60/63 requirement.

(b) Reasonable response steps shall be tak en when indicated by the provisions of a monitoring condition as follows:

(1) Reasonable response steps shall be taken as set forth in the Permittee’s current Compliance Response Plan or Operation, Maintenance and Monitoring (OMM) Plan (or Parametric Monitoring Plan and Start-up, Shutdown, and Malfunction (SSM) Plan); or

(2) If none of the reasonable response steps listed in the Compliance Response Plan or Operation, Maintenance and Monitoring (OMM) Plan (or Parametric Monitoring Plan and Start-up, Shutdow n, and Malfunction (SSM) Plan) is applicable or responsive to the excu rsion, the Permittee shall devise and implement additional response steps as ex peditiously as practical. Taking such additional response steps shall not be cons idered a deviation from this permit so long as the Permittee documents such response steps in accordance with this

condition.

(3) If the Permittee determines that additional response steps would necessitate that

the emissions unit or contro l device be shut down, and it will be ten (10) days or

more until the unit or device will be shut down, then the Permittee shall promptly notify the IDEM, OAQ of the expected date of the shut down. The notification shall also include the status of the applicable compliance monitoring parameter with respect to normal, and the results of the response actions taken up to the

time of notification.

(4) Failure to take reasonable response steps shall be considered a deviation from the permit.

(c) The Permittee is not required to take any further response steps for any of the following

reasons:

(1) A false reading occurs due to the malfunction of the monitoring equipment and prompt action was taken to correct the monitoring equipment.

(2) The Permittee has determined that the monitoring parameters established in the permit conditions are technically inappropriate, has previously submitted a request for a minor permit modification to the permit, and such request has not

been denied.

(3) An automatic measurement was tak en when the process wa s not operating.

(4) The process has already returned or is returning to operating within “normal” parameters and no response steps are required.

(d) When implementing reasonable steps in re sponse to a monitoring condition, if the

Permittee determines that an exceedance of an emission limitation has occurred, the Permittee shall report such deviations pursu ant to Section B-Deviations from Permit Requirements and Conditions.

(e) The Permittee shall record all instances when, in accordance with Section D, response steps are taken. In the event of an em ergency, the provisions of 326 IAC 2-7-16 (Emergency Provisions) requiri ng prompt corrective action to mitigate emissions shall prevail.Eli Lilly and Company-Tippecanoe Labs 4 th Significant Permit Modifica tion No. 157-22717-00006 Page 30 of 226 Lafayette, Indiana Modified by: Aida De Guzman OP No. T157-6879-00006 Permit Reviewer: Dr. Trip Sinha

C.14 Actions Related to Noncompliance Demonstrated by a Stack Test [326 IAC 2-7-5] [326 IAC 2-7-6]

(a) When the results of a stack test performed in conformance with Section C - Performance Testing, of this permit exceed the level s pecified in any condition of this permit, the Permittee shall take appropriate response actions. The Permittee shall submit a description of these response actions to IDEM, OAQ, within thirty (30) days of receipt of the test results. The Permittee shall take appropriate action to minimize excess emissions from the affected facility while the response actions are being implemented.

(b) A retest to demonstrate compliance shall be performed within one hundred twenty (120) days of receipt of the original test results. Should the Permittee demonstrate to IDEM, OAQ that retesting in one hundred and twenty (120) days is not practicable, IDEM, OAQ may extend the retesting deadline.

(c) IDEM, OAQ reserves the authority to take any actions allowed under law in response to noncompliant stack tests.

The response action documents submitted pursuant to this condition do require the certification by the “responsible official” as defined by 326 IAC 2-7-1(34).

Record Keeping and Reporting Requirements [326 IAC 2-7-5(3)] [326 IAC 2-7-19]

C.15 Emission Statement [326 IAC 2-7-5(3)(C)(iii)][ 326 IAC 2-7-5(7)][326 IAC 2-7-19(c)][326 IAC 2-6]

(a) Pursuant to 326 IAC 2-6-3(a)(1), the Permitt ee shall submit by July 1 of each year an emission statement covering the previous ca lendar year. The emission statement shall contain, at a minimum, the information spec ified in 326 IAC 2-6-4(c) and shall meet the following requirements:

(1) Indicate estimated actual emissions of all pollutants listed in 326 IAC 2-6-4(a);

(2) Indicate estimated actual emissions of regulated pollutants as defined by 326 IAC 2-7-1(32) (“Regulated pollutant which is used only for purposes of Section 19 of this rule”) from the source, fo r purposes of Part 70 fee assessment.

The statement must be submitted to:

Indiana Department of Environmental Management Technical Support and Modeling Section, Office of Air Quality

100 North Senate Avenue Indianapolis, Indiana 46204-2251

The emission statement does require the cert ification by the “responsible official” as defined by 326 IAC 2-7-1(34).

(b) The emission statement requir ed by this permit shall be considered timely if the date postmarked on the envelope or certified mail re ceipt, or affixed by the shipper on the private shipping receipt, is on or before the date it is due. If the document is submitted by any other means, it shall be considered timely if received by IDEM, OAQ, on or before

the date it is due.

C.16 General Record Keeping Requirements [326 IAC 2-7-5(3)] [326 IAC 2-7-6] [326 IAC 2-2]

(a) Records of all required monitoring data, repo rts and support information required by this permit shall be retained for a period of at l east five (5) years from the date of monitoring sample, measurement, or report. These records shall be physically present or electronically accessible at the source locati on for a minimum of three (3) years. The records may be stored elsewhere for the remain ing two (2) years as long as they areEli Lilly and Company-Tippecanoe Labs 4 th Significant Permit Modifica tion No. 157-22717-00006 Page 31 of 226 Lafayette, Indiana Modified by: Aida De Guzman OP No. T157-6879-00006 Permit Reviewer: Dr. Trip Sinha

available upon request. If the Commissioner makes a request for records to the Permittee, the Permittee shall furnish the records to the Commissioner within a

reasonable time.

(b) Unless otherwise specified in this permi t, all record keeping requirements not already legally required shall be implemented within ninety (90) days of permit issuance.

(c) If there is a reasonable possibility that a “project” (as defined in 326 IAC 2-2-1 (qq)) at an existing emissions unit, other than projects at a source with Plant-wide Applicability Limitation (PAL)), which is not part of a “major modification” (as defined in 326 IAC 2-2-1 (ee)) may result in significant emissions increase and the Permittee elects to utilize the “projected actual emissions” (as defined in 326 IAC 2-2-1 (rr)), the Pe rmittee shall comply with following:

(1) construction of the “project” (as defin ed in 326 IAC 2-2-1 (qq) at an existing emissions unit, document and maintain the following records:

(A) A description of the project.

(B) Identification of any emissions un it whose emissions of a regulated new source review pollutant could be affected by the project.

(C) A description of the applicability test used to determine that the project is not a major modification for any regulated NSR pollutant, including:

(i) Baseline actual emissions;

(ii) Projected actual emissions;

(iii) Amount of emissions excl uded under section 326 IAC 2-2- 1(rr)(2)(A)(iii); and

(iv) An explanation for why t he amount was excluded, and any netting calculations, if applicable.

(2) Monitor the emissions of any regulated NSR pollutant that could increase as a result of the project and that is emitted by any existing emissions unit identified in (1)(B) above; and

(3) Calculate and maintain a record of the annual emissions, in tons per year on a calendar year basis, for a period of five (5) years following resumption of regular operations after the change, or for a peri od of ten (10) years following resumption of regular operations after the change if the project increases the design capacity of or the potential to emit that regul ated NSR pollutant at the emissions unit.

C.17 General Reporting Requirements [326 IAC 2-7-5(3)(C)] [326 IAC 2-1.1-11][326 IAC 2-2]

(a) The Permittee shall submit the attached Quarterly Deviation and Compliance Monitoring Report or its equivalent. Any deviation from permit requirements, the date(s) of each deviation, the cause of the deviation, and t he response steps taken must be reported. This report shall be submitted within thirty (30) days of the end of the reporting period. The Quarterly Deviation and Compliance Monito ring Report shall include the certification by the “responsible official” as defined by 326 IAC 2-7-1(34).

(b) The report required in (a) of this condition and reports required by conditions in Section D of this permit shall be submitted to:

Indiana Department of Environmental Management Compliance Data Section, Office of Air QualityEli Lilly and Company-Tippecanoe Labs 4 th Significant Permit Modifica tion No. 157-22717-00006 Page 32 of 226 Lafayette, Indiana Modified by: Aida De Guzman OP No. T157-6879-00006 Permit Reviewer: Dr. Trip Sinha

100 North Senate Avenue Indianapolis, Indiana 46204-2251

(c) Unless otherwise specified in this permit, any notice, report, or other submission required by this permit shall be considered timely if the date postmarked on the envelope or certified mail receipt, or affixed by the shipper on the private shipping receipt, is on or

before the date it is due. If the document is submitted by any other means, it shall be considered timely if received by IDEM, OAQ, on or before the date it is due.

(d) Unless otherwise specified in this permit, a ll reports required in Section D of this permit

shall be submitted within thir ty (30) days of the end of the reporting period. Unless otherwise specified in this permit, all re ports do require the ce rtification by the “responsible official” as defined by 326 IAC 2-7-1(34).

(e) The first report shall cover the period comme ncing on the date of issuance of this permit and ending on the last day of the reporting period. Reporting periods are based on calendar years, unless otherwise specified in this permit. For the purpose of this permit “calendar year” means the twelve (12) month period from January 1 to December 31

inclusive.

(f) If the Permittee is required to comply with the recordkeeping provisions of (c) in Section C.17 for any “project” (as defined in 326 IAC 2-2-1 (qq)) at an existing emissions unit, and the project meets the following criteria, then t he Permittee shall submit a report to IDEM,
OAQ:

(1) The annual emissions, in tons per year , from the project identified in (c)(1) in

Section C.17 exceed the baseline ac tual emissions, as documented and maintained under Section C.17(c)(1)(C)(i), by a significant amount, as defined in 326 IAC 2-2-1 (xx), for that regulated NSR pollutant, and

(2) The emissions differ from the preconstruction projection as documented and maintained under Section C.17(c)(1)(C)(ii).

(g) The report for project at an existing emissions unit shall be submitted within sixty (60) days after the end of the year and contain the following:

(1) The name, address, and telephone number of the major stationary source.

(2) The annual emissions calculated in accordance with (c)(2) and (3) in Section

C.17.

(3) The emissions calculated under the actual -to-projected actual test stated in 326 IAC 2-2-2(d)(3).

(4) Any other information that the Permi ttee deems fit to include in this report,

Reports required in this part shall be submitted to:

Indiana Department of Environmental Management Air Compliance Section, Office of Air Quality

100 North Senate Avenue Indianapolis, Indiana 46204-2251Eli Lilly and Company-Tippecanoe Labs 4 th Significant Permit Modifica tion No. 157-22717-00006 Page 33 of 226 Lafayette, Indiana Modified by: Aida De Guzman OP No. T157-6879-00006 Permit Reviewer: Dr. Trip Sinha

(h) The Permittee shall make the information required to be documented and maintained in accordance with (c) in Section C.17 availabl e for review upon a request for inspection by IDEM, OAQ. The general public may request this information from the IDEM, OAQ under

326 IAC 17.1.

Stratospheric Ozone Protection

C.18 Compliance with 40 CFR 82 and 326 IAC 22-1

The Permittee shall comply with all the applicabl e provisions of 40 CFR Part 82, wherever applicable to activities at the source.Eli Lilly and Company-Tippecanoe Labs 4 th Significant Permit Modifica tion No. 157-22717-00006 Page 34 of 226 Lafayette, Indiana Modified by: Aida De Guzman OP No. T157-6879-00006 Permit Reviewer: Dr. Trip Sinha

SECTION D.1 UTILITIES OPERATION CONDITIONS

Facility Description [326 IAC 2-7-5(15)]

The information describing the pr ocesses contained in the following facility description boxes is descriptive information and does not constitute enforceable conditions.

This section will no longer be in effect when all of the coal chutes to Boilers No. 1, No. 2, and No. 3 are disconnected, starting September 13, 2007.

(a) The following emission units are subject to applicable requirements described in this D section:

Emission*

Unit ID Emission Unit Description Stack/Vent Nominal Capacity UOM Control

Device

Building T6:

BLR001 Coal/Natural Gas Boiler S-T6-BLR001 92 MMBtu/hr Multiclone001

BLR002 Coal/Natural Gas Boiler S-T6-BLR002 92 MMBtu/hr Multiclone002

BLR003 Coal/Natural Gas Boiler S-T6-BLR003 92 MMBtu/hr Multiclone003

BLR004 Natural Gas/Fuel Oil Boiler S-T6-BLR004 142 MMBtu/hr None

BLR005 Natural Gas/Fuel Oil Boiler S-T6-BLR005 97 MMBtu/hr None

CONASH Ash Handling System PV-T6-
CONASH 1805 lbs/hr Baghouse

* In this permit, boilers BLR001, BLR002, BLR003, BLR004, and BLR005 are referred to as Boilers 1, 2, 3, 4, and 5, respectively.

(b) The following emission units are not subject to applicable requirements described in this D section and are listed only for informational purposes:

Emission

Unit ID Emission Unit Description Stack/Vent Nominal Capacity UOM Control

Device

Outside Building T6:

OILTK001* Fuel Oil Storage Tank PV-T6-
OILTK001 250,000 gallons None

COAL Coal Pile N/A N/A N/A N/A

CNV001-

CNV005 Covered Coal Conveyor System N/A N/A N/A N/A

* Emission units marked with a single aste risk are insignificant activities as defi ned in 326 IAC 2-7-1(21). Specifically, the fuel oil storage tank is an insignificant ac tivity pursuant to 326 IAC 2-7-1(21)(A)-(C).

Emission Limitations and Sta ndards [326 IAC 2-7-5(1)]

D.1.0 SECTION D.1 Requirements Supersession

The requirements of this SECTION D.1 shall be superseded by SECTION D.20 and therefore, shall no longer be in effect starting September 13, 2007.

D.1.1 Particulate Matter (PM) Limitations [326 IA C 6-2-3, 326 IAC 6-3, and PC (79) 1510 Issued March 22, 1982 (Revised by this permit)]

(a) Pursuant to 326 IAC 6-2-3(b) (Particulate Matter Emission Limitations for Sources of Indirect Heating), particulat e emissions from each coal /natural gas -fired boiler (Boilers 1, 2, and 3) shall not exceed 0.56 pounds per million British thermal units (MMBtu) heat input.Eli Lilly and Company-Tippecanoe Labs 4 th Significant Permit Modifica tion No. 157-22717-00006 Page 35 of 226 Lafayette, Indiana Modified by: Aida De Guzman OP No. T157-6879-00006 Permit Reviewer: Dr. Trip Sinha

(b) Pursuant to 326 IAC 6-2-3(c) (Particulate Matter Emission Limitations for Sources of Indirect Heating), particulate emissions fr om Boiler 4 shall not exceed 0.39 pounds per MMBtu heat input.

(c) Pursuant to 326 IAC 6-2-3(c) (Particulate Matter Emission Limitations for Sources of Indirect Heating), particulate emissions fr om Boiler 5 shall not exceed 0.31 pounds per MMBtu heat input. (d) Pursuant to 326 IAC 6-3-2, particulate matter emissions from the ash handling system shall not exceed 3.83 pounds per hour based on a maximum throughput of 0.902 tons of ash per hour.

D.1.2 Sulfur Dioxide (SO 2 ) Limitations [326 IAC 7-1.1-2, and PC (79) 1510 Issued March 22, 1982 (Revised by this permit)]

(a) Pursuant to 326 IAC 7-1.1-2 (Sulfu r Dioxide Emission Limitations), the SO 2 emissions

from each of the coal /natural gas -fired boilers (Boilers 1, 2 and 3) shall not exceed 6.0 pounds per MMBtu heat input.

(b) Pursuant to 326 IAC 7-1.1-2 (Sulfu r Dioxide Emission Limitations), the SO 2 emissions from Boiler 4 shall be limited to 0.5 pounds per MMBtu heat input, when burning No. 2 fuel oil. Pursuant to 326 IAC 7-2-1, compliance with this standard is based on a calendar month average. This emission limit correlates to a maximum fuel oil sulfur content of 0.49 percent by weight.

(c) Pursuant to 326 IAC 7-1.1-2 (Sulfu r Dioxide Emission Limitations), the SO 2 emissions from Boiler 5 shall not exceed 0.5 pounds per MMBtu heat input, when burning No. 2 fuel

oil. This emission limit correlates to a maximu m fuel oil sulfur content of 0.49 percent by weight.

D.1.3 Reserved

D.1.4 Temporary Alternative Opacity Limitations [326 IAC 5-1-3]

Pursuant to 326 IAC 5-1-3 (Temporary Alternativ e Opacity Limitations), the following conditions apply as an alternative to the opacity limitations in Section C – Opacity:

(a) When building a new fire in a boiler, or shutting down a boiler, opacity may exceed the applicable limit established in 326 IAC 5-1-2 and stated in Section C - Opacity. However, opacity levels shall not exceed sixty perc ent (60%) for any six (6) minute averaging period. Opacity in excess of the applicable lim it established in 326 IAC 5-1-2 shall not continue for more than two (2) six (6)-minute averaging periods in any twenty-four (24) hour period.

(b) When removing ashes from the fuel bed or furnace in a boiler or blowing tubes, opacity may exceed the applicable limit established in 326 IAC 5-1-2 and stated in Section C - Opacity. However, opacity levels shall no t exceed sixty percent (60%) for any six (6) minute averaging period and opacity in exce ss of the applicable limit shall not continue for more than one (1) six (6) minute averaging periods in any sixty (60) minute period. The averaging periods shall not be permitted for more than three (3) six (6) minute averaging periods in a twelve (12) hour period.

D.1.5 Preventive Maintenance Plans /Start-up Shutdown, and Malfuncti on Plans [326 IAC 2-7-5(13)] [40 CFR Part 63, Subpart DDDDD]

(a) Until September 12, 2007 or until startup of new boilers, whichever is first, a Preventive Maintenance Plan, in accordance with Secti on B - Preventive Maintenance Plan, of this permit, is required for the coal /natural gas -fired boilers and associated multiclone control

devices.Eli Lilly and Company-Tippecanoe Labs 4 th Significant Permit Modifica tion No. 157-22717-00006 Page 36 of 226 Lafayette, Indiana Modified by: Aida De Guzman OP No. T157-6879-00006 Permit Reviewer: Dr. Trip Sinha

(b) After September 12, 2007 or upon startup of new boilers, whichever is first, a Start-Up Shutdown, and Malfunction Plan is required for each boiler as required by 40 CFR 63 Part DDDDD, and in accordance with Section B – Preventative Maintenance Plan, of this permit.

Additional Emission Limitations and Standards ar e included in Conditions D.1.17 and D.1.18.

Testing and Monitoring Requirements [326 IAC 2-7-6(1), (6)] [326 IAC 2-7-5(1)]

D.1.6 Testing Requirements [326 IAC 2-7- 6(1), (6)] [40 CFR Part 63, Subpart DDDDD]

(a) The Permittee shall perform particulate matter performance tests for Boilers 1, 2 and 3 utilizing Methods 5 or 17 (40 CFR 60, Appendix A) for PM or other methods as approved by the Commissioner. These tests shall be re peated every third calendar year from the calendar year of the most recently comple ted compliance stack test. The requirements for conducting performance tests are descri bed in Section C – Performance Testing.

(b) No emissions testing is required for the bo ilers for compliance with particulate matter for boilers 4, and 5, limit established in Condit ions D.1.1 at this time. However, IDEM may require performance testing when necessar y to determine compliance. The requirements for conducting performance tests are descri bed in Section C – Performance Testing.

(c) All performance testing and/or fuel analys es shall be performed as required by 40 CFR

63 Part DDDDD.

D.1.7 Coal Sampling and Analysis for SO 2 [326 IAC 3-7 and 326 IAC 7-2]

The Permittee shall collect coal sampling and analysis data on a calendar month average in accordance with one of the following method s specified in 326 IAC 3 for each of the coal /natural

gas -fired boilers (Boilers 1, 2 and 3):

(a) Coal sampling and analysis shall be performed using one of the following procedures:

(1) Sampling and analyzing the coal according to the Permittee’s Coal Sampling and Assay Plan, submitted pursuant to 326 IAC 3-7-5(a). The following minimum sampling and analysis requirements shall be met:

(A) The coal sample acquisition point shall be at a location where representative samples of the total coal flow to be combusted by the facility or facilities may be obtained. A single as-bunkered or as-burned sampling station may be used to represent the coal to be combusted by multiple facilities using the same stockpile feed system;

(B) Coal shall be sampled at least two (2) times per day and at least one (1) time per twelve (12) hour period unl ess no coal is bunkered during the preceding twelve (12) hour period. This permit condition satisfies the requirements of 326 IAC 3-7-2(b)(3)(B);

(C) Minimum sample size shall be five hundred (500) grams;

(D) Samples shall be composited and analyzed at the end of each calendar month;

(E) Preparation of the coal sample, heat content analysis, and sulfur content analysis shall be determined pursuant to 326 IAC 3-7-2(c), (d), (e); or

(2) Sample and analyze the coal pursuant to 326 IAC 3-7-2(b).Eli Lilly and Company-Tippecanoe Labs 4 th Significant Permit Modifica tion No. 157-22717-00006 Page 37 of 226 Lafayette, Indiana Modified by: Aida De Guzman OP No. T157-6879-00006 Permit Reviewer: Dr. Trip Sinha

(b) Upon written notification to IDEM by a facility owner or operator, continuous emission monitoring data collected and reported pursuant to 326 IAC 3-5-1 may be used as the means for determining compliance with the emis sion limitations in 326 IAC 7-1.1-2. Upon such notification, the other requirements of 326 IAC 7-2 shall not apply. [326 IAC 7-2- 1(g)]

D.1.8 Fuel Oil Sampling and Analysis for SO 2 [326 IAC 7-2]

The Permittee shall utilize one of the following methods for Boilers 4 and 5 when burning fuel oil:

(a) Provide vendor analysis of quantity, heat cont ent and sulfur content of fuel delivered, if accompanied by a certification;

(b) Analyze the oil sample to determine the sulfur content of the oil via the procedures in 326
IAC 3-7-4.

(1) Oil samples may be collected from the fuel tank immediately after the fuel tank is filled and before any oil is combusted; and

(2) If a partially empty fuel tank is re filled, a new sample and analysis would be required upon filling; or

(c) Conduct a stack test for sulfur dioxide emissions from the boiler, using 40 CFR 60, Appendix A, Method 6 in accordance with the procedures in 326 IAC 3-6, which is conducted with such frequency as to generate the amount of information required by (a) or (b) above. [326 IAC 7-2-1(d)]

D.1.9 Reserved

D.1.10 Alternative Operating Scenarios

(a) The Permittee may elect to perform the tests in D.1.6(a) while burning a mixture of natural gas and coal (co-fire). The Permittee shall inform IDEM in writing whenever the Co-Fire operating scenario is used, in which case the following monitoring requirements and limits apply.

(1) The Permittee shall install and operate a gas flow meter and a steam flow rate flowmeter on each boiler where the co-fire option is used. A Preventative Maintenance Plan, in accordance with Section B – Preventative Maintenance Plan, is required for the monitors.

(2) The 24-hour daily average gas ratio (R) shall be greater than or equal to the value determined in the most recent performance test. The gas ratio shall be calculated by:

R = Average (N 1 /S 1 + N 2 /S 2 + ... + N i /S i )

Where N i = natural gas flow rate, in acfm, for each 15 minute period
S i = steam flow rate from boiler, in lb/hr, for each 15 minute period

(3) If the 24-hour daily gas ratio falls below the gas ratio established pursuant to the performance test, or if the gas-burners fail to operate in a normal manner, the permittee shall take reasonable response steps in accordance with Section C - Compliance Response Plan - Preparation, Implementation, Records, and Reports. Failure to take response steps in accordance with Section C - Compliance Response Plan - Preparation, Implementation, Records, and Reports, shall be considered a deviation from this permit.Eli Lilly and Company-Tippecanoe Labs 4 th Significant Permit Modifica tion No. 157-22717-00006 Page 38 of 226 Lafayette, Indiana Modified by: Aida De Guzman OP No. T157-6879-00006 Permit Reviewer: Dr. Trip Sinha

(b) If the Permittee has conducted a performance te st under co-fired conditions to establish aminimum gas ratio, but subsequently wants to operate a boiler without natural gas cofired or at a gas ratio that is lower than the ratio established at the performance test, then the Permittee must demonstrate that partic ulate matter emissions are less than the emission limits in D.1.1(a) pursuant to a perfo rmance test as described in D.1.6(a) under the desired operating conditions. The Permi ttee may not begin to operate under the new conditions until the performance test results are submitted to IDEM, OAQ.

D.1.11 Visible Emission Notations

(a) Visible emission notations of the stack exhaus ts of Boilers 1, 2 and 3 shall be performed once per day during normal daylight operations. A trained employee shall record whether

emissions are normal or abnormal.

(b) For processes operated continuously, “nor mal” means those conditions prevailing, or expected to prevail, eighty percent (80%) of the time the process is in operation, not counting startup or shutdown time.

(c) In the case of batch or discontinuous opera tions, readings shall be taken during that part of the operation that would normally be ex pected to cause the greatest emissions.

(d) A trained employee is an employee who has worked at the plant at least one (1) month and has been trained in the appearance and char acteristics of normal visible emissions for that specific process.

(e) The Compliance Response Plan for the boilers shall contain troubleshooting contingency and response steps for when an abnormal emission is observed.

Record Keeping and Reporting Requiremen ts [326 IAC 2-7-5(3)] [326 IAC 2-7-19]

D.1.12 Coal Characteristi cs and Consumption Records

The Permittee shall record the information described in items (a) through (d) below on a calendar month basis for Boilers 1, 2, and 3.

(a) The amount (expressed in tons) of coal burned;

(b) The average sulfur content (express ed in percentage) of coal burned;

(c) The average heat content (expressed in Btu per pound) of the coal burned; and

(d) The average sulfur dioxide emission rate (expressed in pounds per MMBtu).

D.1.13 Fuel Oil Characterist ics and Consumption Records

The Permittee shall record the information described in item (a) through (d) below on a calendar month basis for Boiler 4, and Boiler 5:

(a) The amount (expressed in thousands of gallons (Mgal)) of No. 2 fuel oil burned in Boilers 4 and 5;

(b) The average sulfur content (expressed in per centage by weight) of the No. 2 fuel oil burned in Boilers 4 and 5;

(c) The average higher heating value (expressed in Btu per gallon) of the No. 2 fuel oil burned in Boilers 4 and 5; andEli Lilly and Company-Tippecanoe Labs 4 th Significant Permit Modifica tion No. 157-22717-00006 Page 39 of 226 Lafayette, Indiana Modified by: Aida De Guzman OP No. T157-6879-00006 Permit Reviewer: Dr. Trip Sinha

(d) The average sulfur dioxide emission rate (expressed in pounds per MMBtu) of the No. 2

fuel oil for Boilers 4 and 5.

D.1.14 Reserved

D.1.15 Standard Operating Procedures

Pursuant to 326 IAC 3-7-5(a), the Permittee s hall maintain and implement a standard operating procedure (SOP) for coal sampling, handling, analysis, quality control, quality assurance, and data reporting of the information collected pursuant to 326 IAC 3-7-2. In addition, any revision to the SOP shall be submitted to IDEM, OAQ.

D.1.16 Visible Emissions Notations

The Permittee shall record the visible emissions notations of the coal /natural gas -fired boilers
stack exhaust in accordance with Condition D.1.11.

D.1.17 Record Keeping Requirements

(a) Records and data required by D.1.10 shall be maintained for boilers operating under the

co-fire scenario. This condition shall be in effect until September 12, 2007, when coal will no longer be used for fuel.

(b) After September 12, 2007 or upon startup on new boilers, whichever is first, the applicable record keeping requirements of 40 CFR 63 Part DDDDD shall apply.

D.1.18 Reporting Requirements

(a) The Permittee shall submit quarterly summary reports of the monthly coal characteristic and consumption records required by Conditi on D.1.12 for Boilers 1, 2 and 3. This condition shall be in effect until September 12, 2007, when coal will no longer be used for

fuel.

(b) The Permittee shall submit quarterly summary reports of the monthly fuel oil characteristic and consumption records requi red by Condition D.1.13 for Boilers 4 and 5.

(c) Reserved

(d) All reports shall be submitted to the address listed in Section C – General Reporting Requirements, of this permit, using the reporti ng form located at the end of this permit, or its equivalent, within thirty (30) days after the end of the quarter being reported. The report does require the certific ation by the “responsible offi cial” as defined by 326 IAC 2- 7-1(34).

Additional Record Keeping and Reporting Requirements are included in Conditions D.1.22 and D.1.23.

Modifications and Construction Requirements [326 IAC 2-7-10.5, 326 IAC 2-7-12 and 326 IAC 2-2]

D.1.19 Modifications and Construction: Advanc e Approval of Permit Conditions Requirements

The emission units described in this D section are not subject to the advance approval permit

conditions.Eli Lilly and Company-Tippecanoe Labs 4 th Significant Permit Modifica tion No. 157-22717-00006 Page 40 of 226 Lafayette, Indiana Modified by: Aida De Guzman OP No. T157-6879-00006 Permit Reviewer: Dr. Trip Sinha

Emission Limitations and Sta ndards [326 IAC 2-7-5(1)]

D.1.20 National Emission Standards for Hazardous Air Pollutants for Industrial, Commercial, and

Institutional Boilers and Process Heaters [40 CFR Part 63, Subpart DDDDD]

After September 12, 2007 or upon startup of new bo ilers, whichever is first, the Permittee shall comply with the emission limitations and standards of 40 CF R 63, Subpart DDDDD.

D.1.21 General Provisions Relating to NESHAP [326 IAC 20-1][40 CFR Part 63, Subpart A] [40 CFR Part 63, Subpart DDDDD]

(a) Pursuant to 40 CFR 63.7565, the prov isions of 40 CFR 63 Subpart A - General Provisions, which are incorporated as 326 IAC 20-1-1, apply to the affected source for the large solid fuel subcategory (Boilers 1, 2, and 3) and the affected source large gaseous fuel subcategory (Boilers 4 and 5), ex cept when otherwise specified in 40 CFR 63 Subpart DDDDD. The Permittee must comp ly with 40 CFR 63 Subpart A as stated in

40 CFR 63.7565.

(b) Since the applicable requirements associ ated with the compliance options for the affected sources are not included and specific ally identified in this permit, the permit shield authorized by the B section of this per mit in the condition titled Permit Shield, and set out in 326 IAC 2-7-15 does not apply to paragraph (a) of this condition, except as otherwise provided in this condition.

Record Keeping and Reporting Requiremen ts [326 IAC 2-7-5(3)] [326 IAC 2-7-19]

D.1.22 National Emission Standards for Hazardous Air Pollutants for Industrial, Commercial, and Institutional Boilers and Process Heaters - Notification Requirements [40 CFR 63, Subpart DDDDD]

(a) After September 12, 2007 or upon startup of new boilers, whichever is first, the applicable notification and reporting requirements of 40 CFR 63 Part DDDDD shall apply.

(b) All notifications and reports shall be su bmitted to the address listed in Section C – General Reporting Requirements, of this permit. The notifications do require the certification by the “responsible offi cial” as defined by 326 IAC 2-7-1(34).

D.1.23 Requirement to Submit a Significant Pe rmit Modification Application [326 IAC 2-7-12] [326 IAC 2-7-5] [40 CFR Pa rt 63, Subpart DDDDD]

The Permittee shall submit an application for a significant permit modification to IDEM, OAQ to include information regarding whic h compliance option or options will be chosen in the Part 70 permit for the affected source for the large solid fuel subcategory (Boilers 1, 2, and 3).

(a) The significant permit modification application shall be consistent with 326 IAC 2-7-12, including information sufficient for IDEM, OAQ to incorporate into the Part 70 permit the applicable requirements of 40 CFR 63, Subpart DDDDD, a description of the affected source and activities subject to the standard, and a description of how the Permittee will meet the applicable requirements of the standard.Eli Lilly and Company-Tippecanoe Labs 4 th Significant Permit Modifica tion No. 157-22717-00006 Page 41 of 226 Lafayette, Indiana Modified by: Aida De Guzman OP No. T157-6879-00006 Permit Reviewer: Dr. Trip Sinha

(b) The significant permit modification application shall be submitted no later than nine months prior to September 12, 2007.

(c) The significant permit modification application shall be submitted to:

Indiana Department of Environmental Management Permits Branch, Office of Air Quality

100 North Senate Avenue Indianapolis, Indiana 46204-2251Eli Lilly and Company-Tippecanoe Labs 4 th Significant Permit Modifica tion No. 157-22717-00006 Page 42 of 226 Lafayette, Indiana Modified by: Aida De Guzman OP No. T157-6879-00006 Permit Reviewer: Dr. Trip Sinha

SECTION D.2 UTILITIES SUPPO RT OPERATION CONDITIONS

Facility Description [326 IAC 2-7-5(15)]

The information describing the pr ocesses contained in the following facility description boxes is descriptive information and does not constitute enforceable conditions:

(a) The following emissions units are is subject to applicable requirements described in this D

section:

Emission

Unit ID Emission Unit Description Stack/Vent Nominal Capacity UOM Control Device

Building T6:

T121 Diesel Generator N/A 1250 KW None

(b) The following emission units are not subject to applicable requirements described in this D section and are listed only for informational purposes:

Emission

Unit ID Emission Unit Description Stack/Vent Nominal Capacity UOM Control Device

Building T5:

T5* Diesel Generator N/A 380 HP None

Portable Units:

T62* Diesel Generator N/A 1100 KW None

T135* Diesel Generator N/A 390 HP None

T78* Diesel Compressor N/A 58 KW None

T89-1* Diesel Compressor N/A 58 KW None

T89-2* Diesel Compressor N/A 58 KW None

Building T97/T98:

T97/T98* Glycol System N/A 45,000 gallon None

Building T9/T23:

T9/T23* Lime Storage Silo N/A 79.5 lb/hr None

Building T70:

Gen-7001* Diesel Generator N/A 300 KW None

* Emission units marked with a single asterisk are insi gnificant activiti es as defined in 326 IAC 2-7-1(21).

Emission Limitations and Sta ndards [326 IAC 2-7-5(1)]

D.2.1 Nitrogen Oxide (NOx) Emissi on Limitations [326 IAC 2-2 and CP 157-3319 Issued February 21, 1995]

Generator T121 shall not exceed 900 hours of operation per 12 consecutive month period rolled on a monthly basis. This operational limitation limits NOx emissions to less than 40 tons per year; therefore, the Prevention of Significant De terioration (PSD) rules pursuant to 326 IAC 2-2 does not apply.

D.2.2 Preventive Maintenance Plan [326 IAC 2-7-5(13)]

A Preventive Maintenance Plan, in accordance wi th Section B - Preventive Maintenance Plan, of this permit, is not required for the fa cility described in this Section.Eli Lilly and Company-Tippecanoe Labs 4 th Significant Permit Modifica tion No. 157-22717-00006 Page 43 of 226 Lafayette, Indiana Modified by: Aida De Guzman OP No. T157-6879-00006 Permit Reviewer: Dr. Trip Sinha

Testing and Monitoring Requirements

D.2.3 Testing Requirements [326 IAC 2-7-6(1) , (6)] [326 IAC 2-7-6(1)] [326 IAC 2-7-5(1)]

No emissions testing is required for the emission unit s described in this Section, at this time, but IDEM may require compliance testing at any specific time when necessary to determine if the facility is in compliance. The requirements fo r conducting performance tests that may be required by IDEM in the future are described in Section C – Performance Testing.

Record Keeping and Reporting Requiremen ts [326 IAC 2-7-5(3)] [326 IAC 2-7-19]

D.2.4 Generator Hours of Operation

The Permittee shall record the actual hours of operation for Generator T121. The records shall report the actual hours of operation per 12-m onth period, rolled on a monthly basis using the reporting form located at the end of this permit, or equivalent.

D.2.5 Reporting Requirements

A quarterly report of the information specified in Condition D.2.4 shall be submitted to the address listed in Section C - General Reporting Requirements, within thirty (30) days after the end of the quarter being reported. This report submitted by the Permittee requires t he certification by the “responsible official” as defined by 326 IAC 2-7-1(34).

Modifications and Construction Requirements [326 IAC 2-7-10.5, 326 IAC 2-7-12 and 326 IAC 2-2]

D.2.6 Modifications and Construction: Advance A pproval of Permit Conditions Requirements

The emission units described in this D section are not subject to the advance approval permit

conditions.Eli Lilly and Company-Tippecanoe Labs 4 th Significant Permit Modifica tion No. 157-22717-00006 Page 44 of 226 Lafayette, Indiana Modified by: Aida De Guzman OP No. T157-6879-00006 Permit Reviewer: Dr. Trip Sinha

SECTION D.3 FERMENTATION OPERATION CONDITIONS

Facility Description [326 IAC 2-7-5(15)]

The information describing the pr ocesses contained in the following facility description boxes is descriptive information and does not constitute enforceable conditions:

(a) The following emissions units are subject to applicable requirements described in this D section:

Emission

Unit ID Emission Unit Description Stack/Vent Nominal Capacity UOM Control

Device

Building T1 – Raw Material Prep Area:

MIX001* Dry Raw Material Mixer PV-T1-T52348 N/A N/A

MIX002* Dry Raw Material Mixer PV-T1-T52348 N/A N/A

MCNV001 Conveyor of Raw Material Mixers PV-T1-T52348 N/A N/A Dust Collector

T52348**

Building T2 – Fermentation Production Area:

TK001* Bump Tank S-T2-FERM 5000 liters None

TK002* Bump Tank S-T2-FERM 5000 liters None

TK003* Bump Tank S-T2-FERM 5000 liters None

TK004* Bump Tank S-T2-FERM 5000 liters None

TK011* Bump Tank S-T2-FERM 5000 liters None

TK012* Bump Tank S-T2-FERM 5000 liters None

TK013* Bump Tank S-T2-FERM 5000 liters None

TK014* Bump Tank S-T2-FERM 5000 liters None

TK005* Fermentor Tank S-T2-FERM 60000 liters

TK006* Fermentor Tank S-T2-FERM 60000 liters

TK007* Fermentor Tank S-T2-FERM 60000 liters Cyclone

T67457**

TK008* Fermentor Tank S-T2-FERM 60000 liters

TK009* Fermentor Tank S-T2-FERM 60000 liters

TK010* Fermentor Tank S-T2-FERM 60000 liters Cyclone

T67458**

TK015* Fermentor Tank S-T2-FERM 60000 liters Cyclone

T67462**

TK016* Fermentor Tank S-T2-FERM 60000 liters Cyclone

T67463**

TK017* Fermentor Tank S-T2-FERM 60000 liters Cyclone

T67464**

TK018* Fermentor Tank S-T2-FERM 60000 liters Cyclone

T65689**

TK019* Fermentor Tank S-T2-FERM 60000 liters Cyclone

T52221**

TK020* Fermentor Tank S-T2-FERM 60000 liters Cyclone

T52228**Eli Lilly and Company-Tippecanoe Labs 4 th Significant Permit Modifica tion No. 157-22717-00006 Page 45 of 226 Lafayette, Indiana Modified by: Aida De Guzman OP No. T157-6879-00006 Permit Reviewer: Dr. Trip Sinha

Emission

Unit ID Emission Unit Description Stack/Vent Nominal Capacity UOM Control

Device

Building T2A – Fermentation Production Area:

TK021* Bump Tank S-T2-FERM 10000 liters None

TK022* Bump Tank S-T2-FERM 10000 liters None

TK023* Bump Tank S-T2-FERM 10000 liters None

TK024* Bump Tank S-T2-FERM 10000 liters None

TK025* Fermentor Tank S-T2-FERM 120000 liters

TK026* Fermentor Tank S-T2-FERM 120000 liters

TK027* Fermentor Tank S-T2-FERM 120000 liters Cyclone

T67459**

TK028* Fermentor Tank S-T2-FERM 120000 liters Cyclone

T67696**

TK029* Fermentor Tank S-T2-FERM 120000 liters Cyclone

T67697**

TK030* Fermentor Tank S-T2-FERM 120000 liters Cyclone

T67698**

Building T2C – Fermentation Production Area:

TK043* Bump Tank S-T2-FERM 37625 liters Cyclone

T65363**

TK044* Bump Tank S-T2-FERM 37625 liters Cyclone

T65364**

TK048* Fermentor Tank S-T2-FERM 254000 liters Cyclone

T65367**

TK049* Fermentor Tank S-T2-FERM 254000 liters Cyclone

T65359**

TK050* Fermentor Tank S-T2-FERM 254000 liters Cyclone

T65360**

* Emissions units marked with a single asterisk are insigni ficant activities as defined in 326 IAC 2-7-1(21)(A)-(C). ** All control devices are voluntary units and are not requir ed to demonstrate compliance wi th any applicable regulations.

(b) The following emissions units are insignificant activities pursuant to 326 IAC 2-7-1(21)(A)-(C) and are not subject to applicable requirements described in this D section:

Emission Unit

ID Emission Unit Description Stack/Vent Nominal Capacity UOM Control

Device

Building T46 – Material Storage Area:

BIN001 Dry Raw Material Storage Bin PV-T46-T67454 23000 liters

BIN002 Dry Raw Material Storage Bin PV-T46-T67454 23000 liters

BIN003 Dry Raw Material Storage Bin PV-T46-T67454 23000 liters

BIN004 Dry Raw Material Storage Bin PV-T46-T67454 23000 liters Baghouse

T67454**

BIN005 Dry Raw Material Storage Bin PV-T46-T67455 23000 liters

BIN006 Dry Raw Material Storage Bin PV-T46-T67455 23000 liters

BIN007 Dry Raw Material Storage Bin PV-T46-T67455 23000 liters Baghouse

T67455**

BIN008 Dry Raw Material Storage Bin PV-T46-T67455 23000 litersEli Lilly and Company-Tippecanoe Labs 4 th Significant Permit Modifica tion No. 157-22717-00006 Page 46 of 226 Lafayette, Indiana Modified by: Aida De Guzman OP No. T157-6879-00006 Permit Reviewer: Dr. Trip Sinha

Emission Unit

ID Emission Unit Description Stack/Vent Nominal Capacity UOM Control

Device

BIN009 Dry Raw Material Storage Bin PV-T46-T67659 23000 liters

BIN010 Dry Raw Material Storage Bin PV-T46-T67659 23000 liters Baghouse

T67659**

BIN011 Dry Raw Material Storage Bin PV-T46-T67456 23000 liters

BIN012 Dry Raw Material Storage Bin PV-T46-T67456 23000 liters Baghouse

T67456**

Building T1 – Raw Material Prep Area:

BLO001 Railcar Pneumatic Conveyor N/A N/A liters None

DISP001 Automated Dispensing St ation PV-T1-T44984 N/A liters

DISSC001 Dispensing Scale PV-T1-T44984 N/A liters Dust Collector

T44984**

TK121 Make Up Tank PV-T1-314512 10150 liters

TK122 Make Up Tank PV-T1-314512 10150 liters

TK123 Make Up Tank PV-T1-314512 2100 liters Rotoclone

314512**

TK123A Make Up Area Tank N/A 380 liters None

TK124 Make Up Tank PV-T1-314512 2100 liters Rotoclone

314512**

TSLU Slurry Tank N/A 3600 liters None

TK125 Make Up Tank PV-T1-T67489 24600 liters Rotoclone

T67489**

TK126 Make Up Tank PV-T1-T67492 24600 liters Rotoclone

T67492**

SC001 Liquid Weigh Scale Tank N/A N/A liters None

Building T1 – Liquid Storage Area:

TK231 Liquid Storage Tank N/A 20000 liters None

TK232 Whole Broth Storage T ank N/A 200000 liters None

TK233 Whole Broth Storage T ank N/A 200000 liters None

TK234 Whole Broth Storage T ank N/A 200000 liters None

TK235 Whole Broth Storage T ank N/A 200000 liters None

TK236 Waste Holding Tank N/A 200000 liters None

TK237 Liquid Storage Tank N/A 200000 liters None

TK241 Liquid Storage Tank N/A 100000 liters None

TK242 Liquid Storage Tank N/A 100000 liters None

TK243 Liquid Storage Tank N/A 100000 liters None

TK244 Liquid Storage Tank N/A 100000 liters None

TK245 Liquid Storage Tank N/A 100000 liters None

TK246 Liquid Storage Tank N/A 100000 liters None

TK247 Liquid Storage Tank N/A 100000 liters None

TK248 Liquid Storage Tank N/A 30400 liters None

TK249 Liquid Storage Tank N/A 45300 liters None

Building T1 – Filter Room:

TK813 Lime Tank PV-T1-316488 8600 liters RotocloneEli Lilly and Company-Tippecanoe Labs 4 th Significant Permit Modifica tion No. 157-22717-00006 Page 47 of 226 Lafayette, Indiana Modified by: Aida De Guzman OP No. T157-6879-00006 Permit Reviewer: Dr. Trip Sinha

Emission Unit

ID Emission Unit Description Stack/Vent Nominal Capacity UOM Control

Device

TK814 Filter Room Tank (Tank 8.5) PV-T1-316488 9600 liters 316488**

TK143 Slurry Tank N/A 3800 liters None

TK144 Slurry Tank N/A 3800 liters None

Building T63 – Product Storage Area:

TK255 Whole Broth Tank N/A 94700 liters None

** All control devices are voluntary units and are not required to demonstrate compliance with any applicable regulations.

Emission Limitations and Sta ndards [326 IAC 2-7-5(1)]

D.3.1 Non-Applicability Determination of Pharmace utical MACT Standards [40 CFR 63, Subpart GGG]

The emission units associated with the fermentation operations are not subject to the requirements of 40 CFR 63, Subpart GGG (Pha rmaceutical MACT St andards) because these emission units do not process, use, or produce hazardous air pollutant (HAP) emissions in excess of 50 ppmv pursuant to 40 CFR 63.125 1 (Process Vent Definition).

D.3.2 Non-Applicability Determination of State VO C Emission Standards [326 IAC 8-5-3, 326 IAC 8-1- 6]

(a) The emission units associated with the fermentation operations do not manufacture pharmaceutical products by chemical sy nthesis. Therefore, the emission units associated with the fermentation operations are not subject to the requirements of 326 IAC 8-5-3 (VOC Emission Limitations for Synthesized Pharmaceutical Manufacturing Operations).

(b) The emission units associated with the fermentation operations are not subject to the requirements of 326 IAC 8-1-6 (Best Availabl e Control Technologies for VOC Emissions)

because the VOC emissions associated with each emission unit or emission project are less than 25 tons per year.

D.3.3 Particulate Matter (PM) Emission Limitations [326 IAC 6-3-2]

Pursuant to 326 IAC 6-3-2, Registration 157-322 0 Issued September 3, 1993, Registration 157- 4466 Issued May 8, 1995, and Registration 157-7144 Issued December 4, 1996, the emission units presented in the table below shall not exceed the following particulate matter emission rates based on the following maximum throughput rates:

Emission Unit Description Emission Unit ID Maximum Process Weight Rate (ton/hr) Allowable PM

Emission Rate (lb/hr)

Building T1 – Raw Material Prep Area:

Dry Raw Material Mixers + Conveyor for Mixers MIX001, MIX002,
MCNV001 0.881 3.77, combined

Building T2 – Fermentation Production Area:

Bump Tanks TK001 – TK004

Fermentor Tanks TK005 – TK010

Bump Tanks TK011 – TK014

Fermentor Tanks TK015 – TK020 18.3 28.7, combinedEli Lilly and Company-Tippecanoe Labs 4 th Significant Permit Modifica tion No. 157-22717-00006 Page 48 of 226 Lafayette, Indiana Modified by: Aida De Guzman OP No. T157-6879-00006 Permit Reviewer: Dr. Trip Sinha

Emission Unit Description Emission Unit ID Maximum Process Weight Rate (ton/hr) Allowable PM

Emission Rate (lb/hr)

Building T2A – Fermentation Production Area:

Bump Tanks TK021 – TK024

Fermentor Tanks TK025 – TK027,

TK029 – TK030

Fermentor Tank TK028 18.3 28.7, combined

Building 2C – Fermentation Production Area:

Bump Tanks TK043 – TK044

Fermentor Tanks TK048 – TK050 31.6 5.5, combined

D.3.4 Preventive Maintenance Plan [326 IAC 2-7-5(13)]

A Preventive Maintenance Plan, in accordance wi th Section B - Preventive Maintenance Plan, of this permit, is not required for any of the emis sion units or control devices described in this
Section.

Testing and Monitoring Requirements [326 IAC 2-7-6(1) (6)] [326 IAC 2-7-5(1)]

D.3.5 Testing Requirements [326 IAC 2-7-6(1), (6)]

No emissions testing is required for the emission un its described in this Section at this time, but IDEM may require compliance testing at any specific time when necessary to determine if the facility is in compliance. The requirements fo r conducting performance tests that may be required by IDEM in the future are described in Section C – Performance Testing.

Modifications and Construction Requirements [326 IAC 2-7-10.5, 326 IAC 2-7-12 and 326 IAC 2-2]

D.3.6 Modifications and Construction: Advance A pproval of Permit Conditions Requirements

The emission units described in this D section are not subject to the advance approval permit

conditions.Eli Lilly and Company-Tippecanoe Labs 4 th Significant Permit Modifica tion No. 157-22717-00006 Page 49 of 226 Lafayette, Indiana Modified by: Aida De Guzman OP No. T157-6879-00006 Permit Reviewer: Dr. Trip Sinha

SECTION D.4 FERMENTED PRODUCTS - PURIFICATION OPERATION CONDITIONS

Facility Description [326 IAC 2-7-5(15)]

The information describing the pr ocesses contained in the following facility description boxes is descriptive information and does not constitute enforceable conditions:

(a) The following emissions units are subject to applicable requirements described in this D section:

Emission

Unit ID Emission Unit Description Stack/Vent Nominal Capacity UOM Control

Device

Building T3 – Purification Production Area:

T3-RVD040 Rotary Vacuum Dryer Vent 500 gallons Dust Collector**

Building T147 – Storage Tank Module:

T147-TK001 Storage Tank Vent 190 00 gallons Vent Condenser**

T147-TK002 Storage Tank Vent 190 00 gallons Vent Condenser**

T147-TK003 Storage Tank Vent 190 00 gallons Vent Condenser**

T147-TK004 Storage Tank Vent 190 00 gallons Vent Condenser**

T147-TK005 Storage Tank Vent 190 00 gallons Vent Condenser**

T147-TK006 Storage Tank Vent 190 00 gallons Vent Condenser**

T147-TK007 Storage Tank Vent 190 00 gallons Vent Condenser**

T147-TK008 Storage Tank Vent 190 00 gallons Vent Condenser**

T147-TK009 Storage Tank Vent 190 00 gallons Vent Condenser**

T147-TK010 Storage Tank Vent 190 00 gallons Vent Condenser**

T147-TK011 Storage Tank Vent 190 00 gallons Vent Condenser**

T147-TK012 Storage Tank Vent 190 00 gallons Vent Condenser**

** All control devices are voluntary units and are not requir ed to demonstrate compliance wi th any applicable regulations.

(b) The following emission units are not subject to applicable requirements described in this D

section:

Emission

Unit ID Emission Unit Description Stack/Vent Nominal Capacity UOM Control

Device

Building T3 – Purification Production Area:

T3-TK47718* Azo Receiver Tank Vent 1000 gallons None

T3-TK56* Vent Condensate Tank Vent 30 gallons None

T3-CENT001* Stacked Plate Centrifuge Vent 20 gallons None

T3-CENT002* Stacked Plate Centrifuge Vent 20 gallons None

T3-CENT003* Stacked Plate Centrifuge Vent 20 gallons None

T3-CENT004* Stacked Plate Centrifuge Vent 20 gallons None

T3-COL001* East Carbon Column Vent 200 gallons None

T3-TK261* Process Tank Vent 500 gallons NoneEli Lilly and Company-Tippecanoe Labs 4 th Significant Permit Modifica tion No. 157-22717-00006 Page 50 of 226 Lafayette, Indiana Modified by: Aida De Guzman OP No. T157-6879-00006 Permit Reviewer: Dr. Trip Sinha

Emission

Unit ID Emission Unit Description Stack/Vent Nominal Capacity UOM Control

Device

T3-TK327-1T* Process Tank Vent 500 gallons None

T3-TK330* Process Tank Vent 4000 gallons None

T3-TK332-3T* Process Tank Vent 3000 gallons None

T3-TK337-1T* Process Tank - Acid tank Vent 500 gallons None

T3-TK338-1T* Process Tank Vent 500 gallons None

T3-TK338-2T* Process Tank Vent 500 gallons None

T3-TK341-1T* Process Tank Vent 500 gallons None

T3-TK346-1T* Amyl Acetate Tank Vent 500 gallons None

T3-TK353-1T* Receive Amyl Acetate from

EVAP305 Vent 1000 gallons None

T3-TK355-1T* Process Tank Vent 1000 gallons None

T3-TK357-1T* Process Tank Vent 1000 gallons None

T3-TK376-1T* Process Tank Vent 2000 gallons None

T3-TK376-2T* Process Tank Vent 2000 gallons None

T3-TK376-3T* Process Tank Vent 2000 gallons None

T3-TK378-1T* Process Tank Vent 500 gallons None

T3-TK394* Chemical Waste Tank Vent 2000 gallons None

T3-TK397-1T* Spent Aqueous T ank Vent 2000 gallons None

T3-TK399* Acid Wash Tank Vent 500 gallons None

T3-EVAP300* Swenson Evaporator Vent 400 gallons None

T3-EVAP305 Evaporator Vent 800 gallons None

T3-COL002* West Carbon Column Vent 200 gallons None

Building T40 – Purification Production Area:

T40-TK050* Holding Tank Vent 750 gallons None

T40-TK051* Tank Vent 2000 gallons None

T40-TK052* Tank Vent 2000 gallons None

T40-TK053* Holding Tank Vent 2000 gallons None

T40-TK055 Tank Vent 500 gallons None

T40-TK060* Still Vent 2000 gallons None

Building T4 – Solvent Recovery:

T4-COL001 Distilling Column Vent 269 cf None

T4-TK001* Process Tank Vent 1985 gallons None

T4* Tylosin System Vent N/A N/A None

T4-TK101* Process Tank Condenser 25000 gallons Vent Condenser**

Building T39 – Product Storage:

T39-TK021* Storage Tank Vent 2000 gallons None

T39-TK022* Storage Tank Vent 2000 gallons None

T39-TK023* Storage Tank Vent 2000 gallons NoneEli Lilly and Company-Tippecanoe Labs 4 th Significant Permit Modifica tion No. 157-22717-00006 Page 51 of 226 Lafayette, Indiana Modified by: Aida De Guzman OP No. T157-6879-00006 Permit Reviewer: Dr. Trip Sinha

Emission

Unit ID Emission Unit Description Stack/Vent Nominal Capacity UOM Control

Device

T39-TK030* Storage Tank Vent 5000 gallons None

T39-TK031* Storage Tank Vent 5000 gallons None

T39-TK036* Storage Tank Vent 5000 gallons None

Outside Storage Tanks:

TK420-1T* Hydrochloric Acid Tank 12000 gallons Acid Scrubber**

TK434-1T* Sulfuric Acid Tank Scrubber Vent 15000 gallons None

* Emission units marked with an aste risk are insignificant activities as defined by 326 IAC 2-7-1(21)(A)-(C).

** Control devices marked with a double asterisk are vo luntary control units and are not required to demonstrate compliance with any regulations.

Emission Limitations and Sta ndards [326 IAC 2-7-5(1)]

D.4.1 Non-Applicability Determination of Pharmace utical MACT Standards [40 CFR 63, Subpart GGG]

Except for the T3 rotary vacuum dryer, the emission units associated with the purification operations are not subject to the requirement s of 40 CFR 63, Subpart GGG (Pharmaceutical MACT Standards) because these emission units do not process, use, or produce hazardous air pollutant (HAP) emissions in excess of 50 ppmv pursuant to 40 CFR 63.1251 (Process Vent Definition).

D.4.2 Non-Applicability Determination of State VO C Emission Standards [326 IAC 8-5-3, Registration Issued November 8, 1990, and Amendment Issued November 10, 1992]

(a) Except for the T3 rotary vacuum dryer, t he emission units associated with the purification operations do not manufacture pharmaceutic al products by chemical synthesis. Therefore, except for the T3 rotary vacuum dryer, these emission units are not subject to the requirements of 326 IAC 8-5-3 (VOC Emission Limitations for Synthesized Pharmaceutical Manufacturing Operations).

(b) The T3 rotary vacuum dryer does not dry pharmaceutical products by chemical synthesis with a potential to emit equal to or greater than 15 pounds per day. Therefore, this dryer is not subject to the requirements of 326 IAC 8-5-3.

D.4.3 T3 Rotary Vacuum Dryer Process Vent Standard [40 CFR 63.1254(A)(2)]

Pursuant to 40 CFR 63 Subpart GGG (Pharma ceutical MACT Standard), undiluted and uncontrolled process vent streams equal to or greater than 50 ppmv HAP from the T3 rotary vacuum dryer shall be limited to an annual mass lim it of 900 kilograms (kg) per 365-day period to comply with the individual process-based mass limit standards under 40 CFR 63.1254(a)(2)(i). The sum of process vent emissions from a ll uncontrolled processes generated during the manufacturing of pharmaceutical products shall not exceed an annual mass limit of 1800 kg HAP per 365-day period pursuant to 40 CFR 63.1254(a)(2)(ii).

D.4.4 Preventive Maintenance Plan [326 IAC 2-7-5(13)]

A Preventive Maintenance Plan, in accordance wi th Section B - Preventive Maintenance Plan, of this permit, is not required for any of the facilitie s or control devices described in this Section.Eli Lilly and Company-Tippecanoe Labs 4 th Significant Permit Modifica tion No. 157-22717-00006 Page 52 of 226 Lafayette, Indiana Modified by: Aida De Guzman OP No. T157-6879-00006 Permit Reviewer: Dr. Trip Sinha

Testing and Monitoring Requirements [326 IA C 2-7-6(1) (6)] [326 IAC 2-7-5(1)]

D.4.5 Testing Requirements [326 IAC 2-7-6(1), (6)]

N o emissions testing is required for the emission uni ts described in this Section at this time, but IDEM may require compliance testing at any specific time when necessary to determine if the facility is in compliance. The requirements fo r conducting performance tests that may be required by IDEM in the future are described in Section C – Performance Testing.

Record Keeping and Reporting Requiremen ts [326 IAC 2-7-5(3)] [326 IAC 2-7-19]

D.4.6 Record Keeping Requirements [40 CFR 63.1254 (a)(2), 40 CFR 60.116b(b), Registration Issued November 8, 1990, and Amendment Issued November 10, 1992]

(a) The Permittee shall maintain the following records of the T3 rotary vacuum dryer:

(1) Daily rolling annual total HAP emissions from process vent streams equal to or greater than 50 ppmv from the T3 rotary vacuum dryer;

(2) Number of batches per year for each batch process;

(3) Standard batch uncontrolled and controlled emissions for each process;

(4) Actual uncontrolled and controlled emissions for each nonstandard batch,; and

(5) Record whether each batch operated was considered a standard batch.

(b) Pursuant to 40 CFR 60.116b(b) [New Sour ce Performance Standard for Solvent Storage Tanks], the Permittee shall maintain record s of the dimensions and capacity of each storage tank associated with the T147 tank module for the life of the source.

Modifications and Construction Requirements [326 IAC 2-7-10.5, 326 IAC 2-7-12 and 326 IAC 2-2]

D.4.7 Modifications and Construction: Advance A pproval of Permit Conditions Requirements

The emission units described in this D section are not subject to the advance approval permit

conditions.Eli Lilly and Company-Tippecanoe Labs 4 th Significant Permit Modifica tion No. 157-22717-00006 Page 53 of 226 Lafayette, Indiana Modified by: Aida De Guzman OP No. T157-6879-00006 Permit Reviewer: Dr. Trip Sinha

SECTION D.5 FERMENTED PRODUCTS – SUPPORT OPERATION CONDITIONS

Facility Description [326 IAC 2-7-5(15)]

The information describing the pr ocesses contained in the following facility description boxes is descriptive information and does not constitute enforceable conditions:

(a) The following emissions units are subject to applicable requirements described in this D section:

Emission

Unit ID Emission Unit Description Stack/Vent Nominal Capacity UOM Control

Device

Fermented Products Wastewater Sludge Management Operations:

T110-TKA Bio-solids Storage Tank T110 300,000 gallons T110 Iron Sponge Reactor

T110-TKB Bio-solids Storage Tank T110 300,000 gallons T110 Iron Sponge Reactor

T110-TKC Bio-solids Storage Tank T110 300,000 gallons T110 Iron Sponge Reactor

T110-TKD Bio-solids Storage Tank T110 300,000 gallons T110 Iron Sponge Reactor

(b) The following emission units are not subject to applicable requirements described in this D

section:

Emission

Unit ID Emission Unit Description Stack/Vent Nominal Capacity UOM Control

Device

Fermented Products Wastewater Treatment (100 Series Tanks):

T174* Thermal Research

Incinerator T174 17 MMBtu/hr N/A

T10-TK101 Aeration Tank* T174 110,000 gallons None

T10-TK102 Aeration Tank* T174 123,000 gallons None

T10-TK103 Aeration Tank* T174 123,000 gallons None

T10-TK104 Aeration Tank* T174 123,000 gallons None

T10-TK120 Aeration Tank T174 270,000 gallons

T10-TK121 Clarifier* T174 122,000 gallons

T10-TK122 Clarifier* T174 122,000 gallons

T10-TK123 Lift Station* T174 27,000 gallons T174**

Incinerator

T10-TK124 Nitrification Tank* At mosphere 1,700,000 gallons None

T10-TK125 Nitrification Tank* At mosphere 1,700,000 gallons None

T10-TK126 Nitrification Tank* At mosphere 1,700,000 gallons None

T10-TK127 Nitrification Clarifier* Atmosphere 90,000 gallons None

T10-TK128 Nitrification Clarifier* Atmosphere 90,000 gallons None

T10-TK132 Final Clarifier* Atmosphere 155,000 gallons NoneEli Lilly and Company-Tippecanoe Labs 4 th Significant Permit Modifica tion No. 157-22717-00006 Page 54 of 226 Lafayette, Indiana Modified by: Aida De Guzman OP No. T157-6879-00006 Permit Reviewer: Dr. Trip Sinha

Emission

Unit ID Emission Unit Description Stack/Vent Nominal Capacity UOM Control

Device

T10-TK142 Final Clarifier* Atmosphere 155,000 gallons None

T79-TK401 Wastewater Tank At mosphere 21,588 gallons None

T79-TK402 Wastewater Tank At mosphere 21,588 gallons None

Fermented Products Wastewater Sludge Management Operations:

T42 Centrifuge* T174 300 gal/min

T42-A Sludge Centrifuge* T174 100 gal/min

T42-B Sludge Centrifuge* T174 150 gal/min T174

Incinerator**

* Emission units marked with an asterisk are insignificant activities as def ined by 326 IAC 2-7-1(21)(A)-(C).

** Control devices marked with a double asterisk are voluntary units and are not required to demonstrate compliance with any applicable regulations.

Emission Limitations and Sta ndards [326 IAC 2-7-5(1)]

D.5.1 Non-Applicability Determination of Pharmace utical MACT Standards [40 CFR 63, Subpart GGG]

The fermented products support operations are not subject to the requirements of 40 CFR 63, Subpart GGG (Pharmaceutical MACT Standards) because:

(a) The emission units associated with t he fermented products wastewater sludge management operations do not process, use, or produce hazardous air pollutant (HAP) emissions in excess of 50 ppmv pursuant to 40 CFR 63.1251 (Process Vent Definition);

and

(b) The wastewater associated with the ferm ented products wastewater treatment plant do

not contain HAP emissions in excess of 5 ppmw pursuant to 40 CFR 63.1251 (Wastewater Stream Definition).

D.5.2 Non-Applicability Determination of St ate VOC Emission Standards [326 IAC 8-5-3]

The emission units associated with the ferm ented products support operations do not manufacture pharmaceutical products by chemical synthesis. Therefore, these emission units are not subject to the requirements of 326 IAC 8-5-3 (VOC Emission Limitations for Synthesized Pharmaceutical Manufacturing Operations).

D.5.3 Emission Limitations and Standards [326 IA C 2-2, CP 157-4363 Issued August 28, 1996, and Amendment 157-8953 Issued November 12, 1997 (Revised by this permit)]

To avoid the requirements of 326 IA C 2-2 (Prevention of Significant Deterioration), the Permittee shall comply with the following:

(a) The total reduced sulfur (TRS) emissions from the iron sponge reactor shall not equal or exceed 2.28 pounds per hour, which is equivalent to 762 micrograms per liter (ug/l). This

emission limitation also satisfies the emissi on limitations for reduced sulfur compounds and hydrogen sulfide; and

(b) TRS, reduced sulfur compounds and hydrogen sulfide emissions from the transfer of biosolids from the storage tanks to trucks shall be controlled by a vapor balance system that exhausts to the iron sponge reactor.Eli Lilly and Company-Tippecanoe Labs 4 th Significant Permit Modifica tion No. 157-22717-00006 Page 55 of 226 Lafayette, Indiana Modified by: Aida De Guzman OP No. T157-6879-00006 Permit Reviewer: Dr. Trip Sinha

D.5.4 Preventive Maintenance Plan [326 IAC 2-7-5(13)]

A Preventive Maintenance Plan, in accordance wi th Section B - Preventive Maintenance Plan, of this permit, is required for the iron sponge reactor system.

Testing and Monitoring Requirements [326 IAC 2-7-6(1) (6)] [326 IAC 2-7-5(1)]

D.5.5 Sampling and Analysis Requirements [CP 157-4363 Issued August 28, 1996 (Revised by this permit), and Amendment 157-8953 Issued Novemb er 12, 1997 (Revised by this permit)]

The Permittee shall measure and record the TRS outlet concentration of the air stream to the atmosphere once per calendar week using the sampling protocol and analysis methods most recently approved by IDEM.

D.5.6 Monitoring Requirements [CP 157-4363 Issued August 28, 1996 (Revised by this permit), and Amendment 157-8953 Issued November 12, 1997 (Revised by this permit)]

The Permittee shall monitor and record the pressure drop across the iron sponge reactor annubar once per day. Unless operated under condition s for which the Compliance Response Plan (CRP) specifies otherwise, the pressure drop across t he operating reactor shall be maintained within the range of 0.2 and 2 inches of water column. The CRP for the iron sponge reactor system shall contain troubleshooting contingency and response steps for when the pressure reading is outside of the above-mentioned range for any one reading.

Record Keeping and Reporting Requiremen ts [326 IAC 2-7-5(3)] [326 IAC 2-7-19]

D.5.7 Record Keeping Requirements [CP 157-4363 Is sued August 28, 1996 (Revised by this permit), and Amendment 157-8953 Issued November 12, 1997 (Revised by this permit)]

(a) The Permittee shall maintain the following records:

(1) daily pressure drop readings across the iron sponge reactor annubar; and

(2) weekly analysis of the TRS outlet concentration from the iron sponge reactor.

(b) Pursuant to 40 CFR 60.116b(b), Subpart Kb (New Source Performance Standard for Volatile Organic Liquid Storage Vessels) and CP157-4363, issued August 28, 1996, the Permittee shall keep readily accessible records of the dimensions and capacity for each bio-solids storage tank. These records sha ll be kept for the life of the source.

Modifications and Construction Requirements [326 IAC 2-7-10.5, 326 IAC 2-7-12 and 326 IAC 2-2]

D.5.8 Modifications and Construction: Advance A pproval of Permit Conditions Requirements

The emission units described in this D section are not subject to the advance approval permit

conditions.

Compliance Determination Requirements

D.5.9 Operation of Control Equipment [326 IAC 2-7-6(6)] Except as otherwise provided by statute or rule, or in this permit, the Iron Sponge Reactor shall be operated at all times that the emission uni ts vented to the Iron Sponge Reactor are in operation.Eli Lilly and Company-Tippecanoe Labs 4 th Significant Permit Modifica tion No. 157-22717-00006 Page 56 of 226 Lafayette, Indiana Modified by: Aida De Guzman OP No. T157-6879-00006 Permit Reviewer: Dr. Trip Sinha

SECTION D.6 BULK PHARMACEUTICAL MANUFACTURING (BPM) PRODUCTION OPERATIONS

Facility description [326 IAC 2-7-5(15)]

The information describing the proc esses contained in t he facility description boxes is descriptive

information and does not constitute enforceable conditions:

(a) The emission units listed below are subject to applicable requirements described or referred to in

this D section. The emission units in the BPM production operations can be generally described as process vessels (tanks), crys tallizers, filters, centrifuges, dr yers, process scrubber systems, and process condenser systems and are referred to as process vents under the National
Emission Standards of Hazardous Air Pollutants for Pharmaceutical Production Operations (Pharmaceutical MACT) found at 40 CFR Part 63, Subpart GGG.

General activities such as open manway operations, charging a liquid from a drum to a tank, centrifuge emptying operations, drum filling operation s, or loading wetcake into driers are also defined as process vents. Individual identifica tion of these activities are not listed in the description tables given they are not stationary or continually change. Each of these activity types will follow the compliance requirement s outlined in this permit section.

Ancillary activities, such as heat exchange syst ems, are not considered process vents and have not been included in the description tables.

Source ID Equipment Description Stack/V ent ID Nominal Capacity Control Device

Building T27:

T27-TK30-1 Process Tank RTO 200 gal RTO
T27-TK30-2 Process Tank RTO 200 gal RTO
T27-TK31-1 Process Tank RTO 1000 gal RTO T27-TK31-2 Process Tank RTO 1000 gal RTO
T27-TK31-3 Process Tank RTO 1000 gal RTO
T27-TK31-4 Process Tank RTO 1000 gal RTO
T27-TK31-5 Process Tank RTO 1000 gal RTO
T27-TK32-1 Process Tank RTO 1000 gal RTO
T27-TK32-2 Process Tank RTO 1000 gal RTO T27-TK32-3 Process Tank RTO 1000 gal RTO
T27-TK32-4 Process Tank RTO 1000 gal RTO
T27-TK32-5 Process Tank RTO 1000 gal RTO
T27-TK32-6 Process Tank RTO 1000 gal RTO
T27-TK32-7 Process Tank RTO 350 gal RTO
T27-TK33-1 Process Tank RTO 2000 gal RTO T27-TK33-2 Process Tank RTO 2000 gal RTO
T27-TK33-3 Process Tank RTO 2000 gal RTO
T27-TK33-4 Process Tank RTO 2000 gal RTO
T27-TK33-5 Process Tank RTO 500 gal RTO
T27-TK33-6 Process Tank RTO 1000 gal RTO
T27-TK34-1 Process Tank RTO 750 gal RTO T27-TK34-2 Process Tank RTO 750 gal RTO
T27-TK34-4 Process Tank RTO 750 gal RTO
T27-TK34-5 Process Tank RTO 750 gal RTO
T27-TK34-6 Process Tank RTO 750 gal RTO
T27-TK34-7 Process Tank RTO 1000 gal RTOEli Lilly and Company-Tippecanoe Labs 4 th Significant Permit Modifica tion No. 157-22717-00006 Page 57 of 226 Lafayette, Indiana Modified by: Aida De Guzman OP No. T157-6879-00006 Permit Reviewer: Dr. Trip Sinha

Source ID Equipment Description Stack/V ent ID Nominal Capacity Control Device

T27-TK34-8 Process Tank RTO 350 gal RTO
T27-TK35-1 Process Tank RTO 2000 gal RTO
T27-TK35-2 Process Tank RTO 2000 gal RTO
T27-TK35-3 Process Tank RTO 2000 gal RTO T27-TK35-4 Process Tank RTO 2000 gal RTO
T27-TK35-5 Process Tank RTO 500 gal RTO
T27-TK35-6 Process Tank RTO 2000 gal RTO
T27-TK35-10B Process Tank RTO 1000 gal RTO
T27-TK36-1 Process Tank RTO 2000 gal RTO
T27-TK36-2 Process Tank RTO 1000 gal RTO T27-TK36-3 Process Tank RTO 2000 gal RTO
T27-TK36-6 Process Tank RTO 2000 gal RTO
T27-TK36-7 Process Tank RTO 500 gal RTO
T27-TK37-2A Process Tank RTO 300 gal RTO
T27-TK38-3 Process Tank RTO 1000 gal RTO
T27-TK40-1 Process Tank RTO 2000 gal RTO T27-TK40-2 Process Tank RTO 2000 gal RTO
T27-TK40-4 Process Tank RTO 1000 gal RTO
T27-TK40-5 Process Tank RTO 1500 gal RTO
T27-TK40-6 Process Tank RTO 2000 gal RTO
T27-TK40-6A Process Tank RTO 2000 gal RTO
T27-TK40-7 Process Tank RTO 2000 gal RTO T27-TK40-7A Process Tank RTO 2000 gal RTO
T27-TK40-8 Process Tank RTO 2000 gal RTO
T27-TK40-9 Process Tank RTO 1000 gal RTO
T27-TK40-10 Process Tank RTO 1000 gal RTO
T27-TK40-11 Process Tank RTO 1000 gal RTO
T27-TK40-13 Process Tank RTO 750 gal RTO T27-TK40-14 Process Tank RTO 300 gal RTO
T27-TK40-31 Process Tank RTO 500 gal RTO
T27-TK41-1 Process Tank RTO 750 gal RTO
T27-TK41-3 Process Tank RTO 500 gal RTO
T27-TK41-4 Process Tank RTO 500 gal RTO
T27-TK41-5 Process Tank RTO 1000 gal RTO T27-TK41-6 Process Tank RTO 300 gal RTO
T27-TK42-3 Process Tank RTO 500 gal RTO
T27-TK42-5 Process Tank RTO 1000 gal RTO
T27-TK43-1 Process Tank RTO 750 gal RTO
T27-TK43-2 Process Tank RTO 500 gal RTO
T27-TK44-1 Process Tank RTO 2000 gal RTO T27-TK44-4 Process Tank RTO 2000 gal RTO
T27-TK45-2 Process Tank RTO 1000 gal RTO
T27-TK45-3 Process Tank RTO 1000 gal RTO
T27-TK46-1 Process Tank RTO 1000 gal RTO
T27-TK46-5 Process Tank RTO 1000 gal RTO
T27-TK47-1 Process Tank RTO 1000 gal RTO T27-TK47-2 Process Tank RTO 550 gal RTO
T27-TK47-3 Process Tank RTO 1000 gal RTOEli Lilly and Company-Tippecanoe Labs 4 th Significant Permit Modifica tion No. 157-22717-00006 Page 58 of 226 Lafayette, Indiana Modified by: Aida De Guzman OP No. T157-6879-00006 Permit Reviewer: Dr. Trip Sinha

Source ID Equipment Description Stack/V ent ID Nominal Capacity Control Device

T27-TK47-5 Process Tank RTO 300 gal RTO
T27-TK48-1 Process Tank RTO 300 gal RTO
T27-TK48-1A Process Tank RTO 1000 gal RTO
T27-TK48-2A Process Tank RTO 100 gal RTO T27-TK48-3A Process Tank RTO 500 gal RTO
T27-TK49-1 Process Tank RTO 200 gal RTO
T27-TK50-1 Process Tank RTO 650 gal RTO
T27-TK50-2 Process Tank RTO 150 gal RTO
T27-TK50-3 Process Tank RTO 150 gal RTO
T27-TK50-4 Process Tank RTO 500 gal RTO T27-TK372-A Process Tank RTO 500 gal RTO
T27-CENT9 Centrifuge RTO NA RTO
T27-CENT16 Centrifuge RTO NA RTO
T27-CENT19 Centrifuge RTO NA RTO
T27-CENT30 Centrifuge RTO NA RTO
T27-CENT37 Centrifuge RTO NA RTO T27-CENT38 Centrifuge RTO NA RTO
T27-CENT40 Centrifuge RTO NA RTO

T27-DT46-1 Process Tank RTO RTO
T27-RVD53-2 Process Dryer RTO NA RTO

T27-SCR30-4 Process Scrubber RTO NA RTO

T27-SCR33-7 Process Scrubber RTO NA RTO

T27-SCR34-9 Process Scrubber RTO NA RTO

T27-SCR35-10A Process Scrubber RTO NA RTO

T27-SCR35-10B Process Scrubber RTO NA RTO

T27-VC31-1 Process Condenser RTO NA RTO

T27-VC32-1 Process Condenser RTO NA RTO

T27-VC32-2 Process Condenser RTO NA RTO

T27-VC32-3 Process Condenser RTO NA RTO

T27-VC33-1 Process Condenser RTO NA RTO

T27-VC33-2 Process Condenser RTO NA RTO

T27-VC33-3 Process Condenser RTO NA RTO

T27-VC33-4 Process Condenser RTO NA RTO

T27-VC35-1 Process Condenser RTO NA RTO

T27-VC35-2 Process Condenser RTO NA RTO

T27-VC35-4 Process Condenser RTO NA RTO

T27-VC36-1 Process Condenser RTO NA RTO

T27-VC36-2 Process Condenser RTO NA RTO

T27-VC36-3 Process Condenser RTO NA RTO

T27-VC40 Process Condenser RTO NA RTO

T27-VC40-2 Process Condenser RTO NA RTO

T27-VC40-5 Process Condenser RTO NA RTO

T27-VC40-7A Process Condenser RTO NA RTO

T27-VC43-1 Process Condenser RTO NA RTO

T27-VC44-4 Process Condenser RTO NA RTO

T27-VC45-2 Process Condenser RTO NA RTO

T27-VC46-1 Process Condenser RTO NA RTO

T27-VC47-1 Process Condenser RTO NA RTOEli Lilly and Company-Tippecanoe Labs 4 th Significant Permit Modifica tion No. 157-22717-00006 Page 59 of 226 Lafayette, Indiana Modified by: Aida De Guzman OP No. T157-6879-00006 Permit Reviewer: Dr. Trip Sinha

Source ID Equipment Description Stack/V ent ID Nominal Capacity Control Device

T27-VC48-1 Process Condenser RTO NA RTO

T27-VC48-1A Process Condenser RTO NA RTO

T27-VC49-1 Process Condenser RTO NA RTO

T27-VC50-1 Process Condenser RTO NA RTO

T27-VC53-1 Process Condenser RTO NA RTO

T27-VC53-2 Process Condenser RTO NA RTO

T27-VC53-10 Process Condenser RTO NA RTO

T27-PORTVC Portable Process
Condenser RTO NA RTO

Building T28:

T28-CENT1 Heinkel Centrifuge RTO NA RTO T28-CENT2 Heinkel Centrifuge RTO NA RTO
T28-CENT3 Heinkel Centrifuge RTO NA RTO
T28-CENT15 Centrifuge RTO NA RTO
T28-CENT22 Centrifuge RTO NA RTO T28-CENT24 Centrifuge RTO NA RTO
T28-CENT26 Centrifuge RTO NA RTO
T28-TK28-1 Process Tank RTO 2000 gal RTO
T28-TK28-1A Process Tank RTO 300 gal RTO
T28-TK28-2 Process Tank RTO 1000 gal RTO
T28-TK28-3 Process Tank RTO 2000 gal RTO T28-TK28-3A Process Tank RTO 340 gal RTO
T28-TK28-03 Process Tank RTO 2000 gal RTO
T28-TK28-4 Process Tank RTO 1000 gal RTO
T28-TK28-5 Process Tank RTO 1000 gal RTO
T28-TK28-6 Process Tank RTO 1000 gal RTO
T28-TK28-7 Process Tank RTO 2000 gal RTO T28-TK28-8 Process Tank RTO 2000 gal RTO
T28-TK28-9 Process Tank RTO 1000 gal RTO
T28-TK28-10 Process Tank RTO 2000 gal RTO
T28-TK28-10A Process Tank RTO 340 gal RTO
T28-TK28-11 Process Tank RTO 2000 gal RTO
T28-TK28-12 Process Tank RTO 2000 gal RTO T28-TK28-13 Process Tank RTO 2000 gal RTO
T28-TK28-14 Process Tank RTO 2000 gal RTO
T28-TK28-15 Process Tank RTO 2000 gal RTO
T28-TK28-16 Process Tank RTO 2000 gal RTO
T28-TK28-17 Process Tank RTO 1000 gal RTO
T28-TK28-18 Process Tank RTO 750 gal RTO T28-TK28-19 Process Tank RTO 2000 gal RTO
T28-TK28-20 Process Tank RTO 2000 gal RTO
T28-TK28-21 Process Tank RTO 2000 gal RTO
T28-TK28-22 Process Tank RTO 2000 gal RTO
T28-TK28-23 Process Tank RTO 2000 gal RTO
T28-TK28-24 Process Tank RTO 2000 gal RTO T28-TK28-25 Process Tank RTO 1500 gal RTO
T28-TK28-26 Process Tank RTO 1500 gal RTOEli Lilly and Company-Tippecanoe Labs 4 th Significant Permit Modifica tion No. 157-22717-00006 Page 60 of 226 Lafayette, Indiana Modified by: Aida De Guzman OP No. T157-6879-00006 Permit Reviewer: Dr. Trip Sinha

Source ID Equipment Description Stack/V ent ID Nominal Capacity Control Device

T28-TK28-27 Process Tank RTO 140 gal RTO
T28-TK28-29 Process Tank RTO 1000 gal RTO
T28-TK28-30 Process Tank RTO 500 gal RTO
T28-TK28-31 Process Tank RTO 2000 gal RTO T28-TK28-32 Process Tank RTO 2000 gal RTO
T28-PTK1 Portable Charge Tank RTO 300 gal RTO
T28-PTK2 Portable Charge Tank RTO 300 gal RTO
T28-PTK3 Portable Charge Tank RTO 300 gal RTO

T28-SCR1 Process Scrubber RTO NA RTO

T28-SCR2 Process Scrubber RTO NA RTO

T28-SCR3 Process Scrubber RTO NA RTO

T28-SCR4 Process Scrubber RTO NA RTO

T28-SCR6 Process Scrubber RTO NA RTO
T28-SCRTK1 Scrubber Tank RTO 300 gal RTO
T28-SCRTK2 Scrubber Tank RTO 500 gal RTO
T28-SCRTK4 Scrubber Tank RTO 500 gal RTO

T28-VC28-1 Process Condenser RTO NA RTO

T28-VC28-3 Process Condenser RTO NA RTO

T28-VC28-4 Process Condenser RTO NA RTO

T28-VC28-5 Process Condenser RTO NA RTO

T28-VC28-6 Process Condenser RTO NA RTO

T28-VC28-8 Process Condenser RTO NA RTO

T28-VC28-10 Process Condenser RTO NA RTO

T28-VC28-11 Process Condenser RTO NA RTO

T28-VC28-12 Process Condenser RTO NA RTO

Building T29:

T29-CENT1401 Heinkel Centrifuge RTO 70 gal RTO
T29-CENT2401 Heinkel Centrifuge RTO 70 gal RTO
T29-CENT3401 Heinkel Centrifuge RTO 70 gal RTO T29-DRY1501 Cone Dryer RTO 580 gal RTO
T29-DRY2402 Filter Dryer RTO 863 gal RTO
T29-DRY2502 Filter Dryer RTO 863 gal RTO
T29-DRY3501 Cone Dryer RTO 580 gal RTO
T29-IBC8201 Process Tank RTO 100 gal RTO
T29-IBC8203 Process Tank RTO 150 gal RTO T29-IBC8204 Process Tank RTO 150 gal RTO
T29-IBC8205 Process Tank RTO 150 gal RTO
T29-IBC8206 Process Tank RTO 150 gal RTO
T29-IBC8207 Process Tank RTO 150 gal RTO
T29-IBC8209 Process Tank RTO 150 gal RTO
T29-IBC8216 Process Tank RTO 50 gal RTO T29-IBC8217 Process Tank RTO 50 gal RTO
T29-IBC8251 Process Tank RTO 150 gal RTO
T29-IBC8253 Process Tank RTO 150 gal RTO
T29-IBC8254 Process Tank RTO 150 gal RTO
T29-IBC8256 Process Tank RTO 150 gal RTO
T29-IBC8257 Process Tank RTO 150 gal RTOEli Lilly and Company-Tippecanoe Labs 4 th Significant Permit Modifica tion No. 157-22717-00006 Page 61 of 226 Lafayette, Indiana Modified by: Aida De Guzman OP No. T157-6879-00006 Permit Reviewer: Dr. Trip Sinha

Source ID Equipment Description Stack/V ent ID Nominal Capacity Control Device

T29-IBC8259 Process Tank RTO 150 gal RTO
T29-IBC8380 Process Tank RTO 50 gal RTO
T29-IBC8381 Process Tank RTO 50 gal RTO

T29-SFH1121 Process Tank RTO NA RTO

T29-SFH3121 Process Tank RTO NA RTO
T29-TK1201 Process Tank RTO 2000 gal RTO
T29-TK1202 Process Tank RTO 2000 gal RTO
T29-TK1203 Process Tank RTO 2000 gal RTO
T29-TK1204 Process Tank RTO 2000 gal RTO
T29-TK1205 Process Tank RTO 2000 gal RTO T29-TK2201 Process Tank RTO 1600 gal RTO
T29-TK2202 Process Tank RTO 2000 gal RTO
T29-TK2203 Process Tank RTO 2000 gal RTO
T29-TK2204 Process Tank RTO 2000 gal RTO
T29-TK2205 Process Tank RTO 2000 gal RTO
T29-TK3201 Process Tank RTO 2000 gal RTO T29-TK3202 Process Tank RTO 2000 gal RTO
T29-TK3203 Process Tank RTO 2000 gal RTO
T29-TK3204 Process Tank RTO 2000 gal RTO
T29-TK3205 Process Tank RTO 2000 gal RTO
T29-TK4201 Process Tank RTO 1600 gal RTO
T29-TK4203 Process Tank RTO 2000 gal RTO T29-TK7920 Process Tank RTO 200 gal RTO
T29-TK7921 Process Tank RTO 80 gal RTO
T29-TK8211 Process Tank RTO 100 gal RTO
T29-TK8212 Process Tank RTO 100 gal RTO
T29-TK8213 Process Tank RTO 100 gal RTO
T29-TK8214 Process Tank RTO 100 gal RTO T29-TK8216 Process Tank RTO 50 gal RTO
T29-TK8218 Process Tank RTO 50 gal RTO
T29-TK8220 Process Tank RTO 50 gal RTO

T29-TK8501 Process Tank RTO 0.75 sf RTO

T29-HE1201 Process Condenser RTO NA RTO

T29-HE1202 Process Condenser RTO NA RTO

T29-HE1203 Process Condenser RTO NA RTO

T29-HE1204 Process Condenser RTO NA RTO

T29-HE1205 Process Condenser RTO NA RTO

T29-HE2201 Process Condenser RTO NA RTO

T29-HE2202 Process Condenser RTO NA RTO

T29-HE2203 Process Condenser RTO NA RTO

T29-HE2204 Process Condenser RTO NA RTO

T29-HE2205 Process Condenser RTO NA RTO

T29-HE3201 Process Condenser RTO NA RTO

T29-HE3202 Process Condenser RTO NA RTO

T29-HE3203 Process Condenser RTO NA RTO

T29-HE3204 Process Condenser RTO NA RTO

T29-HE3205 Process Condenser RTO NA RTO

T29-HE4201 Process Condenser RTO NA RTOEli Lilly and Company-Tippecanoe Labs 4 th Significant Permit Modifica tion No. 157-22717-00006 Page 62 of 226 Lafayette, Indiana Modified by: Aida De Guzman OP No. T157-6879-00006 Permit Reviewer: Dr. Trip Sinha

Source ID Equipment Description Stack/V ent ID Nominal Capacity Control Device

T29-HE4203 Process Condenser RTO NA RTO
T29-TK1203A Accumulator Tank RTO 70 gal RTO
T29-TK1204A Accumulator Tank RTO 70 gal RTO
T29-TK1401A Accumulator Tank RTO 70 gal RTO T29-TK2401A Accumulator Tank RTO 70 gal RTO
T29-TK3401A Accumulator Tank RTO 70 gal RTO
T29-TK4201A Accumulator Tank RTO 70 gal RTO

T29-SCR1601 Process Scrubber RTO NA RTO

T29-SCR2601 Process Scrubber RTO NA RTO

T29-SCR3601 Process Scrubber RTO NA RTO

Building T31:

T31-CENT Centrifuge RTO 13 cf RTO T31-CENT504 Centrifuge RTO 13 gal RTO

T31-FD803 Filter Dryer RTO 0.6 m 2 RTO
T31-TK601 Process Tank RTO 500 gal RTO
T31-TK602 Process Tank RTO 500 gal RTO
T31-TK603 Process Tank RTO 500 gal RTO T31-TK604 Process Tank RTO 500 gal RTO
T31-TK611 Process Tank RTO 500 gal RTO
T31-TK611DT01 Process Tank RTO 50 gal RTO
T31-TK612 Process Tank RTO 500gal RTO
T31-TK613 Process Tank RTO 500 gal RTO
T31-TK614 Process Tank RTO 500 gal RTO T31-TK631 Process Tank RTO 300 gal RTO
T31-TK641 Process Tank RTO 100 gal RTO
T31-TK643 Process Tank RTO 100 gal RTO

T31-HE501 Process Condenser RTO N/A RTO

T31-HE503 Process Condenser RTO N/A RTO

T31-HE511 Process Condenser RTO N/A RTO

T31-HE512 Process Condenser RTO N/A RTO

T31-HE531 Process Condenser RTO N/A RTO

T31-HE541 Process Condenser RTO N/A RTO

T31-SCR-OZ Process Scrubber (Ozone) RTO N/A RTO
T31-SCR721 Process Scrubber RTO 200 gal RTO

Building T31A:

T31A-CENT981 Centrifuge RTO N/A RTO
T31A-FD861 Filter Dryer RTO 0.6 m2 RTO
T31A-FD874 Filter Dryer RTO 0.6 m2 RTO
T31A-RVD881 Dryer RTO 100 cf RTO
T31A-RVD891 Dryer RTO 100 cf RTO
T31A-DT683 Drowning Tank 001 RTO NA RTO
T31A-TK621 Process Tank RTO 300 gal RTO
T31A-TK622 Process Tank RTO 800 gal RTO T31A-TK623 Process Tank RTO 400 gal RTO
T31A-TK624 Process Tank RTO 300 gal RTOEli Lilly and Company-Tippecanoe Labs 4 th Significant Permit Modifica tion No. 157-22717-00006 Page 63 of 226 Lafayette, Indiana Modified by: Aida De Guzman OP No. T157-6879-00006 Permit Reviewer: Dr. Trip Sinha

Source ID Equipment Description Stack/V ent ID Nominal Capacity Control Device

T31A-TK625 Process Tank RTO 300 gal RTO
T31A-TK626 Process Tank RTO 500 gal RTO
T31A-TK651 Process Tank RTO 450 gal RTO
T31A-TK661 Process Tank RTO 300 gal RTO T31A-TK681 Process Tank RTO 500 gal RTO
T31A-TK682 Process Tank RTO 500 gal RTO
T31A-TK683 Process Tank RTO 500 gal RTO
T31A-TK684 Process Tank RTO 500 gal RTO
T31A-TK691 Process Tank RTO 500 gal RTO
T31A-TK692 Process Tank RTO 500 gal RTO T31A-TK693 Process Tank RTO 500 gal RTO
T31A-TK694 Process Tank RTO 500 gal RTO
T31A-TK861K Process Tank RTO 50 gal RTO

T31A-HE481 Process Condenser RTO N/A RTO

T31A-HE482 Process Condenser RTO N/A RTO

T31A-HE491 Process Condenser RTO N/A RTO

T31A-HE492 Process Condenser RTO N/A RTO

T31A-HE521 Process Condenser RTO N/A RTO

T31A-HE551 Process Condenser RTO N/A RTO

T31A-HE561 Process Condenser RTO N/A RTO

T31A-HE581 Process Condenser RTO N/A RTO

T31A-HE583 Process Condenser RTO N/A RTO

T31A-HE591 Process Condenser RTO N/A RTO

T31A-HE593 Process Condenser RTO N/A RTO

T31A-HE781 Process Condenser RTO N/A RTO

T31A-HE791 Process Condenser RTO N/A RTO

T31A-SCR261 Process Scrubber RTO N/A RTO

T31A-SCR262 Process Scrubber RTO N/A RTO

T31A-SCR781 Process Sc rubber RTO 200 gal RTO

T31A-SCR791 Process Sc rubber RTO 500 gal RTO
T31A-SCRTK781 Process Scrubber Tank RTO 300 gal RTO
T31A-SCRTK791 Process Scrubber Tank RTO 300 gal RTO

Building T99:

T99-CENT Heinkel Centrifuge RTO NA RTO
T99-PD43 Pan Dryer RTO 528 gal RTO T99-PD44 Pan Dryer RTO 528 gal RTO
T99-RVD1 Rotary Vacuum Dryer RTO 1200 gal RTO
T99-RVD2 Rotary Vacuum Dryer RTO 1200 gal RTO
T99-RVD3 Rotary Vacuum Dryer RTO 1200 gal RTO
T99-RVD5 Rotary Vacuum Dryer RTO 1200 gal RTO
T99-RVD6 Rotary Vacuum Dryer RTO 1200 gal RTO T99-RVD7 Rotary Vacuum Dryer RTO 1200 gal RTO
T99-RVD8 Rotary Vacuum Dryer RTO 1200 gal RTO
T99-FD-9D* Filter Dryer RTO NA RTO
T99-D-9D* Portable Tank RTO 155 gal RTO
T99-D-9B* Condensate Tank RTO 10 gal RTO
T99-TK-D41 Process Tank RTO 300 gal RTOEli Lilly and Company-Tippecanoe Labs 4 th Significant Permit Modifica tion No. 157-22717-00006 Page 64 of 226 Lafayette, Indiana Modified by: Aida De Guzman OP No. T157-6879-00006 Permit Reviewer: Dr. Trip Sinha

Source ID Equipment Description Stack/V ent ID Nominal Capacity Control Device

T99-TK-D42 Process Tank RTO 150 gal RTO

T99-HE43 Process Condenser RTO NA RTO

T99-HE44 Process Condenser RTO NA RTO

Building T100:

T100-CENT60 Centrifuge RTO N/A RTO
T100-CENT61 Centrifuge RTO N/A RTO
T100-CENT62 Centrifuge RTO N/A RTO T100-CENT63 Centrifuge RTO N/A RTO
T100-CENT64 Centrifuge RTO N/A RTO
T100-CENT65 Centrifuge RTO N/A RTO
T100-CENT66 Centrifuge RTO N/A RTO
T100-CENT67 Centrifuge RTO N/A RTO
T100-CENT68 Centrifuge RTO N/A RTO T100-CENT69 Centrifuge RTO N/A RTO
T100-CENT70 Centrifuge RTO N/A RTO
T100-TK1 Process Tank RTO 2000 gal RTO

T100-TK1C Process Tank RTO N/A RTO
T100-TK2 Process Tank RTO 4000 gal RTO
T100-TK3 Process Tank RTO 2000 gal RTO T100-TK4 Process Tank RTO 2000 gal RTO
T100-TK5 Process Tank RTO 2000 gal RTO
T100-Tk5C* Accumulator Tank RTO 50 gal RTO
T100-TK6 Process Tank RTO 2000 gal RTO
T100-TK7 Process Tank RTO 4000 gal RTO
T100-TK8 Process Tank RTO 4000 gal RTO T100-TK8C Process Tank RTO 30 gal RTO
T100-TK9 Process Tank RTO 4000 gal RTO
T100-TK10 Process Tank RTO 4000 gal RTO
T100-TK11 Process Tank RTO 4000 gal RTO
T100-TK12 Process Tank RTO 4000 gal RTO

T100-TK13 Process Tank RTO 3300 Gal RTO T100-TK14 Process Tank RTO 4000 gal RTO
T100-TK15 Process Tank RTO 2000 gal RTO
T100-TK16 Process Tank RTO 2000 gal RTO
T100-TK17 Process Tank RTO 2000 gal RTO
T100-TK18 Process Tank RTO 2000 gal RTO
T100-TK18A* Distillate Tank RTO 200 gal RTO T100-TK18B* Charge Tank RTO 60 gal RTO
T100-TK20 Process Tank RTO 4000 gal RTO
T100-TK21 Process Tank RTO 4000 gal RTO
T100-TK22 Process Tank RTO 2000 gal RTO
T100-TK24 Process Tank RTO 4000 gal RTO
T100-TK24D* Distillate Tank RTO 50 gal RTO T100-TK25 Process Tank RTO 4000 gal RTO
T100-TK26 Process Tank RTO 4000 gal RTO
T100-TK27 Process Tank RTO 4000 gal RTO
T100-TK28 Process Tank RTO 4000 gal RTOEli Lilly and Company-Tippecanoe Labs 4 th Significant Permit Modifica tion No. 157-22717-00006 Page 65 of 226 Lafayette, Indiana Modified by: Aida De Guzman OP No. T157-6879-00006 Permit Reviewer: Dr. Trip Sinha

Source ID Equipment Description Stack/V ent ID Nominal Capacity Control Device

T100-TK29 Process Tank RTO 4000 gal RTO
T100-TK30 Process Tank RTO 4000 gal RTO
T100-TK-30A Process Tank RTO 70 gal RTO
T100-TK31 Process Tank RTO 4000 gal RTO T100-TK31B Process Tank RTO 50 gal RTO
T100-TK32 Process Tank RTO 4000 gal RTO
T100-TK33 Process Tank RTO 1000 gal RTO
T100-TK34 Process Tank RTO 1000 gal RTO
T100-TK35 Process Tank RTO 1000 gal RTO
T100-TK36 Process Tank RTO 1000 gal RTO T100-TK37 Process Tank RTO 1000 gal RTO
T100-TK38 Process Tank RTO 1000 gal RTO

T100 Portable Process Tank RTO N/A RTO T100-PTK1 Portable Cleaning Tank RTO 150 gal RTO

T100-HE1 Process Condenser RTO N/A RTO

T100-HE1C Process Condenser N/A

T100-HE2 Process Condenser RTO N/A RTO

T100-HE4 Process Condenser RTO N/A RTO

T100-HE6 Process Condenser RTO N/A RTO

T100-HE7 Process Condenser RTO N/A RTO

T100-HE8 Process Condenser RTO N/A RTO

T100-HE11 Process Condenser RTO N/A RTO

T100-HE12 Process Condenser RTO N/A RTO

T100-HE13 Process Condenser RTO N/A RTO

T100-HE14 Process Condenser RTO N/A RTO

T100-HE14B Process Condenser RTO N/A RTO

T100-HE16 Process Condenser RTO N/A RTO

T100-HE21A Process Condenser RTO N/A RTO

T100-HE21B Process Condenser RTO N/A RTO

T100-HE26 Process Condenser RTO N/A RTO

T100-HE28 Process Condenser RTO N/A RTO

T100-HE31 Process Condenser RTO N/A RTO
T100-TK14A Accumulator Tank RTO 50 gal RTO
T100-TK21A Accumulator Tank RTO 50 gal RTO
T100-TK39 CIP Tank RTO 500 gal RTO

T100-SCR80 Process Scrubber RTO N/A RTO

T100-SCR81 Process Scrubber RTO N/A RTO

T100-SCR82 Process Scrubber RTO N/A RTO

T100-SCR83 Process Scrubber RTO N/A RTO

T100-SCR84 Process Scrubber RTO N/A RTO

T100-SCR85 Process Scrubber RTO N/A RTO T100-TK82 Scrubber Holding Tank RTO 1000 gal RTO
T100-TK83 Scrubber Holding Tank RTO 1000 gal RTO
T100-TK84 Scrubber Holding Tank RTO 1000 gal RTO
T100-TK85 Scrubber Holding Tank RTO 1000 gal RTO

* Emission units marked with an asteri sk are insignificant activities as defined by 326 IAC 2-7-1(21).Eli Lilly and Company-Tippecanoe Labs 4 th Significant Permit Modifica tion No. 157-22717-00006 Page 66 of 226 Lafayette, Indiana Modified by: Aida De Guzman OP No. T157-6879-00006 Permit Reviewer: Dr. Trip Sinha

Emission Limitations and St andards [326 IAC 2-7-5(1)]

D.6.1 Standards for BPM Process Vents [40 CF R 63.1254, 326 IAC 2-2-3, and 326 IAC 8-5-3]

The following streamlined standards for the BPM process operations satisfy the Maximum Achievable Control Technology Standards for Pharmaceutical Production Operations (Pharmaceutical MACT) for process vents [ 40 CFR 63.1254], Prevention of Significant Deterioration Best Available Control Technolog y (PSD BACT) requirements [326 IAC 2-2-3] and Reasonably Available Control Technology (RACT) requirements for synthesized pharmaceutical manufacturing operations [326 IAC 8-5-3]:

(a) Except as otherwise provided in Conditions D.6.1(c) and D.6.2, t he emission limits and standards applicable for each operating BPM process vent containing undiluted and uncontrolled process vent streams equal to or greater than 50 ppmv HAP 50 ppmv VOC or 15 pounds per day VOC are described in Section D.14 of this permit.

(b) The Permittee shall cover all in-proce ss tanks, having an ex posed liquid surface containing VOC greater than 15 pounds per day unless production, sampling, maintenance, or inspection proc edures require operator access.

(c) The Permittee is not required to cont rol emissions from BPM process vents in accordance with (a) of this sect ion, if it would result in a safety hazard, as long as the sum of the uncontrolled BPM process vent streams within an individual BPM process does not exceed an annual mass limit of 900 kilograms (2000 pounds) of HAP per 365- day period and the sum of all uncontrolled process vent emissions generated during the manufacturing of pharmaceutical products do not exceed an annual mass limit of 1800 kilograms (4000 pounds) of HAP per 365-day period.

(d) The Permittee shall enclose all centrifuges, rotary vacuum filters, and other filters having an exposed liquid surface, where the liquid contains VOC and exerts a total vapor pressure of 0.5 pounds per square inch or more at 20 O C.

D.6.2 Control Strategy for Produ ction Equipment Exhaust Systems [ 40 CFR 63.1254][326 IAC 8-5-3] [326 IAC 2-2-3]

(a) Pursuant to 40 CFR 63.1254, producti on equipment exhaust systems containing

undiluted and uncontrolled exhaust streams with HAP concentrations greater than fifty (50) ppm, HAP shall be routed to the RTO control system. The operation, inspection, and maintenance requirements for the RTO contro l system, and it’s closed - vent system,

used to control emissions from these emission units are described in Section D.14 of this permit.

(b) Pursuant to 326 IAC 8-5-3(b)(2), VOC em issions from production equipment exhaust systems shall not exceed thirty -three (33) pounds per day. If uncontrolled VOC emissions from a production equipment exhaust system w ould exceed thirty three (33) pounds per day, then the Permittee shall route VOC em issions from that production equipment exhaust system to the RTO control system. The operation, inspection, and maintenance requirements for the RTO control system, and its closed vent system, used to control

emissions from these emission units are des cribed in Section D.14 of this permit.

(c) Pursuant to 326 IAC 2-2-3, VOC BACT fo r production equipment exhaust systems not meeting the criteria of D.6.2(a) or D.6.2(b) is no controls. If the pr ocess affiliated with a production equipment exhaust system that is not routed to the RTO control system is

modified in a manner that causes the criteria in Condition D.6.2(a) or D.6.2(b) to apply, the Permittee shall connect the production equi pment exhaust system to the RTO control system before beginning any operations that would cause D.6.2(a) or D.6.2(b) to be applicable.Eli Lilly and Company-Tippecanoe Labs 4 th Significant Permit Modifica tion No. 157-22717-00006 Page 67 of 226 Lafayette, Indiana Modified by: Aida De Guzman OP No. T157-6879-00006 Permit Reviewer: Dr. Trip Sinha

D.6.3 Leak Detection and Repair (LDAR) Standards [326 IAC 2-2-3, 326 IAC 8-5-3, and 40 CFR 63.1255]

The LDAR standards that apply to components as sociated with the BPM production operations are described in Sections E.1 and E.2 of this permit.

D.6.4 Heat Exchange System Requirement s [326 IAC 2-2-3 and 40 CFR 63.1252(c)(2)]

(a) The Permittee shall inspect the physical integrity of heat exc hange systems that use water to cool process equipment or materials used in pharmaceutical manufacturing operations in accordance with the following current good manufacturing practice (CGMP) requirements of 21 CFR 211 to satisfy the streamlined standards of the Pharmaceutical MACT for heat exchange systems [40 CFR 63.1252(c)(2)] and the PSD BACT requirements [326 IAC 2-2-3]:

(1) Assignment of responsibility for maintaining equipment;

(2) Maintenance schedules; and

(3) Description in sufficient detail of t he methods, equipment, and materials used in maintenance operations, and the methods of disassembling and reassembling equipment as necessary to assure proper maintenance.

D.6.5 Startup, Shutdown and Malf unction Requirements [326 IAC 2- 2-3, 40 CFR 63.1259(a)(3), and 40 CFR 63.6(e) and 63.8(c)]

The NESHAP General Provisions for Startup, Shutdown and Malfunction (SSM) Plans [40 CFR 63.6(e) and 63.8(c)] shall be used to satisf y the Pharmaceutical MACT standards [40 CFR 63.1259(a)(3)], and PSD BACT requirements [326 IAC 2-1.1-11].

(a) Pursuant to 40 CFR 63.6(e)(3), the Permi ttee shall develop an SSM Plan to ensure that processes are operated and maintained in a manner which satisfies the general duty to minimize emissions established by 40 CFR 63.6(e)(1)(i), and that all malfunctions are corrected as soon as practicable after thei r occurrence in order to minimize excess emissions. The SSM Plan shall contain the following information:

(1) Detailed plans and/or procedures for operating and maintaining the process during periods of SSM; and

(2) Corrective action program for malfunctioning processes.

(b) The startup, shutdown and malfunction ( SSM) requirements for the RTO control system, and associated closed-vent system, are descr ibed in Section D.14 of this permit.

Testing and Monitoring Requirements [326 IAC 2-7-6(1) (6)] [326 IAC 2-7-5(1)]

D.6.6 Requirements

The requirements for the RTO control system, and its associated closed -vent system, used to

control emissions from the emission units listed in this section are described in Section D.14 of this permit.

D.6.7 Monitoring Requirements

The monitoring requirements for the RTO contro l system, and its associated closed-vent system, used to control emissions from the applicable emissi on units listed in this section are described in Section D.14 of this permit.Eli Lilly and Company-Tippecanoe Labs 4 th Significant Permit Modifica tion No. 157-22717-00006 Page 68 of 226 Lafayette, Indiana Modified by: Aida De Guzman OP No. T157-6879-00006 Permit Reviewer: Dr. Trip Sinha

Record Keeping and Reporting [326 IAC 2-7-5(3) and 326 IAC 2-7-19]

D.6.8 Record Keeping and Reporting Requirements

(a) Record Keeping Requirements

(1) RTO Control System Records - The re cord keeping and reporting requirements for the RTO control system, and associated closed-vent systems, used to control

emissions from the emission units listed in this section are described in Section D.14 of this permit.

(2) Process Records - The Permittee shall maintain the following records if the 98% Control Efficiency Emission Standard is used to demonstrate compliance with the requirements of the Pharmaceutical MA CT (40 CFR Part 63, Subpart GGG):

(A) Daily rolling annual total HAP emissions;

(B) Number of batches per year for each batch process;

(C) Standard batch uncontrolled and contro lled emissions for each process;

(D) Actual uncontrolled and contro lled emissions for each nonstandard batch; and

(E) Record whether each batch operated was considered a standard batch.

(3) Heat Exchange System Records - Maint enance records, including the date, time, and sign off or initials of the individual who completed the task, of all heat exchange systems that use water to cool process equipment or materials used in pharmaceutical manufacturing operations. The Permittee shall track the heat exchange systems that use water to cool process equipment or materials used in pharmaceutical manufacturing operations in an operating scenario maintained in the On-Site Implementation Log (OSIL).

(4) LDAR Records - The record keeping and reporting requirements for the LDAR standards are described in Sections E.1and E.2 of this permit.

(5) SSM Records - The Permittee shall maintain the following records:

(A) Records of the current and superseded versions of SSM Plan.

(B) Occurrence/duration records of each process malfunction.

(C) Information to demonstrate conformance with each SSM is consistent with the procedures in the SSM Plan.

(D) Records of actions taken during each SSM when different from SSM

Plan.

(b) Periodic Reporting Requirements

(1) The following streamlined quarterly reporting requirements shall satisfy the
Pharmaceutical MACT standards [40 CFR 63.1256(b)] and the PSD BACT requirements [326 IAC 2-1.1-11]:

(A) SSM summary reports for the processes.Eli Lilly and Company-Tippecanoe Labs 4 th Significant Permit Modifica tion No. 157-22717-00006 Page 69 of 226 Lafayette, Indiana Modified by: Aida De Guzman OP No. T157-6879-00006 Permit Reviewer: Dr. Trip Sinha

(B) The reporting requirements for t he RTO control system, and associated closed-vent system, that controls emissions from the emission units listed in this section are described in Section D.14 of this permit.

(C) The reporting requirements for t he LDAR standards are described in Sections E.1 and E.2 of this permit.

(c) Immediate Reporting Requirements

The reporting requirements in the NESHAP G eneral Provisions for Startup, Shutdown and Malfunction (SSM) Plans [40 CFR 63.6(e)(3 )] shall be used to satisfy the reporting requirements under the Pharmaceutical MA CT standards [40 CFR 63.1259(a)(3)], and PSD BACT requirements [326 IAC 2-1.1-11].

(1) Any time an action taken by the Permi ttee during an SSM event of a process is not consistent with the procedures specified in the SSM Plan, the Permittee shall report the actions taken for that event. The immediate report shall be submitted to the agency via a telephone call or facsimile within 2 working days after commencing actions inconsistent with the plan.

(2) Within 7 working days after the end of an SSM event of a process where an action taken by the Permittee is not consis tent with the procedures specified in the SSM Plan, the Permittee shall submit a letter containing the following information in accordance with 40 CFR 63.10(d)(5):

(A) Name, title and signature of respon sible official certifying accuracy;

(B) Explanation of the circ umstances for the event;

(C) Reason for not following the SSM Plan; and

(D) Report any excess emissions and/ or parameter monitoring exceedances

are believed to have occurred.

Modifications and Construction Requirements [326 IAC 2-7-10.5, 326 IAC 2-7-12 and 326 IAC 2-2]

D.6.9 Modifications and Construction: Ad vance Approval of Permit Conditions

(a) The Permittee may modify any existing emissi on units listed in this section of the permit without obtaining a source modification appr oval (otherwise required by 326 IAC 2-7- 10.5), a Title V permit modification (otherwise required by 326 IAC 2-7-12), or a Prevention of Significant Deterioration permit (otherwise required by 326 IAC 2-2), provided the modified emission units are s ubject to the same applicable requirements listed in this D section, and the Permittee shall comply with the Change Management and Flexible Permit provisions in Section F.1 of this permit.

(b) The Permittee may construct and install new em ission units of the types described in this D section without obtaining a source modifica tion approval (otherwise required by 326 IAC 2-7-10.5), a Title V permit modification (otherwise required by 326 IAC 2-7-12), or a Prevention of Significant Deterioration permit (otherwise required by 326 IAC 2-2), provided the new emission units are subject to the same applicable requirements listed in this D section, and the Permittee shall comply with the Change Management and Flexible Permit provisions in Section F.1 of this permit.Eli Lilly and Company-Tippecanoe Labs 4 th Significant Permit Modifica tion No. 157-22717-00006 Page 70 of 226 Lafayette, Indiana Modified by: Aida De Guzman OP No. T157-6879-00006 Permit Reviewer: Dr. Trip Sinha

SECTION D.7 BPM SUPPORT OPERATIONS – SOLVENT RECOVERY OPERATIONS

Facility Description [326 IAC 2-7-5(15)]

The information describing the proc esses contained in t he facility description boxes is descriptive

information and does not constitute enforceable conditions:

(a) The emission units listed below are subject to applicable requirements described or referred to in this D section. The BPM solvent recovery emis sion units can be generally described as columns, stills, evaporators, accumulators, process condensers and receivers and are referred to as process vents under the National Emission Standards of Hazardous Air Pollutants for Pharmaceutical Production Operations (Pharma ceutical MACT) found at 40 CFR 63, Subpart GGG and OSW MACT found at 40 CFR 63, Subpart DD. The solvent recovery columns may

also be defined as treatment units under the OSW MACT.

Ancillary activities, such as heat exchange syst ems, are not considered process vents and have not been included in the description tables.

Emission

Unit ID Emission Unit Description Stack/Vent Nominal Capacity Control

Device

Building T19:

T19-STL1 Still T79 1500 gal T79

T19-STL2 Still T79 4000 gal T79

T19-COL3 Column T79 NA T79

T19-REC1 Receiver T79 2000 gal T79

T19-REC10 Receiver T79 2000 gal T79

T19-REC11 Receiver T79 5300 gal T79

T19-REC2 Receiver T79 2000 gal T79

T19-REC3 Receiver T79 2000 gal T79

T19-REC6 Receiver T79 or RTO* 500 gal T79 or RTO*

T19-REC7 Receiver T79 or RTO* 500 gal T79 or RTO*

T19-REC8 Receiver T79 or RTO* 500 gal T79 or RTO*

T19-REC9 Receiver T79 500 gal T79

Building T52:

T52-REC52-3 Receiver T79 2000 gal T79

T52-REC52-4 Receiver T79 2000 gal T79

T52-REC52-1 Stainless Receiver T79 or RTO* 2000 gal T79 or RTO*

T52-REC52-11 Receiver T79 or RTO* 4000 gal T79 or RTO*

T52-REC52-12 Receiver T79 or RTO* 4000 gal T79 or RTO*

T52-REC52-13 Receiver T79 or RTO* 4000 gal T79 or RTO*

T52-REC52-2 Stainless Receiver T79 or RTO* 2000 gal T79 or RTO*

T52-ACC10 Accumulator T79 or RTO* NA T79 or RTO*

T52-ACC5 Accumulator T79 or RTO* NA T79 or RTO*

T52-ACC6 Accumulator T79 or RTO* NA T79 or RTO*

T52-COL52-8 Wash Column T79 or RTO* NA T79 or RTO*

T52-EVAP10 Evaporator T79 or RTO* 2000 gal T79 or RTO*

T52-EVAP5 Evaporator T79 or RTO* 2000 gal T79 or RTO*

T52-EVAP6 Evaporator T79 or RTO* 2000 gal T79 or RTO*

T52-STPR52-14 Steam Stripper T79 or RTO* 250 gal T79 or RTO*

T52-ACC14 Accumulator T79 or RTO* NA T79 or RTO*

Building T61:

T61-COL61-1 Column T79 NA T79

T61-COL61-2 Column T79 NA T79Eli Lilly and Company-Tippecanoe Labs 4 th Significant Permit Modifica tion No. 157-22717-00006 Page 71 of 226 Lafayette, Indiana Modified by: Aida De Guzman OP No. T157-6879-00006 Permit Reviewer: Dr. Trip Sinha

Emission

Unit ID Emission Unit Description Stack/Vent Nominal Capacity Control

Device

T61-COL61-3 Column T79 NA T79

T61-REC1 Receiver T79 5000 gal T79

T61-REC2 Receiver T79 5000 gal T79

T61-REC3 Receiver T79 5000 gal T79

T61-REC4 Receiver T79 5000 gal T79

T61-REC5 Receiver T79 5000 gal T79

T61-REC6 Receiver T79 5000 gal T79

T61-REC7 Receiver T79 5000 gal T79

T61-REC8 Receiver T79 5000 gal T79

* This equipment is currently not in servic e; however, this equipment shall be tied into either the RTO control system or t he T79 control system upon startup.

Emission Limitations and Sta ndards [326 IAC 2-7-5(1)]

D.7.1 Standards for BPM Support Process Vents [ 40 CFR 63.1254, CFR 63.690, 326 IAC 2-2-3, and 326 IAC 8-5-3]

The following streamlined standards for the BPM solvent recovery operations satisfy the Pharmaceutical MACT Standards for proc ess vents [40 CFR 63.1254], OSWRO MACT Standards for process vents [40 CFR 63.690], PSD BACT requirements [326 IAC 2-2-3] and RACT requirements for synthesized pharmaceutic al manufacturing operations [326 IAC 8-5-3]:

(a) Except as otherwise provided in Condition D.7.1(c), the emission limits and standards for each operating BPM process vent containing undiluted and uncontrolled process vent streams equal to or greater than 50 ppmv VOHAP and/or 50 ppmv VOC are described in SECTION D.14 for emission units controlled by the RTO control system and described in SECTION D.15 for emission units controlled by t he T79 fume incinerator control system.

(b) The Permittee shall cover all in-process t anks associated with the BPM solvent recovery operations, having an exposed liquid surface containing VOC greater than 15 pounds per day unless production sampling, maintenance, or inspection procedures require operator

access.

(c) The Permittee is not required to control emissions from BPM Support process vents in accordance with (a) of this sect ion, if it would result in a safety hazard, as long as the sum of the uncontrolled BPM Support proces s vent streams within an individual BPM process does not exceed an annual mass limit of 900 kilograms (2000 pounds) of HAP per 365-day period and the sum of all unco ntrolled process vent emissions generated during the manufacturing of pharmaceutical pr oducts do not exceed an annual mass limit of 1800 kilograms (4000 pounds) of HAP per 365-day period.

(d) The Permittee shall enclose all centrifuges, rotary vacuum filters, and other filters having an exposed liquid surface, where the liquid contains VOC and exerts a total vapor pressure of 0.5 pounds per square inch or more at 20 O C.

D.7.2 Treatment Unit Requirements [326 IAC 2-2-3 and 40 CFR 63.684]

When a solvent recovery column is used as t he final treatment step to treat off-site waste containing VOHAP or VOC equal to or greater than 500 ppmw, the Permittee shall reduce the
VOHAP and VOC concentrations of the off-site materi al to a level that is less than 500 ppmw to satisfy the requirements of 326 IAC 2-2-3 and 40 CFR 63.684(b).Eli Lilly and Company-Tippecanoe Labs 4 th Significant Permit Modifica tion No. 157-22717-00006 Page 72 of 226 Lafayette, Indiana Modified by: Aida De Guzman OP No. T157-6879-00006 Permit Reviewer: Dr. Trip Sinha

D.7.3 Leak Detection and Repair (LDAR) for Fugitive Emissions [326 IAC 2-2-3 and 40 CFR 63.1255]

The LDAR standards that apply to components associated with the BPM solvent recovery operations are described in Sections E.1 and E.2 of this permit.

D.7.4 Heat Exchange System Requirement s [326 IAC 2-2-3 and 40 CFR 63.1252(c)(2)]

(a) The Permittee shall inspect the physical integrity of heat exc hange systems that use water to cool process equipment or materials used in pharmaceutical manufacturing operations in accordance with the following current good manufacturing practice (CGMP) requirements of 21 CFR 211 to satisfy the streamlined standards of the Pharmaceutical MACT for heat exchangers [40 CFR 63. 1252(c)(2)] and the PSD BACT requirements [326 IAC 2-2-3]:

(1) Assignment of responsibility for maintaining equipment;

(2) Maintenance schedules; and

(3) Description in sufficient detail of t he methods, equipment, and materials used in maintenance operations, and the methods of disassembling and reassembling equipment as necessary to assure proper maintenance - 211.67(b)(3).

D.7.5 Startup, Shutdown and Malfunc tion Requirements [326 IAC 2-2- 3, 40 CFR 63.1259(a)(3), 40 CFR 63.697(b)(3), and 40 CFR 63.6(e)(3) and 63.8(c)]

The NESHAP General Provisions for Startup, Shutdown and Malfunction (SSM) Plans [40 CFR 63.6(e) and 63.8(c)] shall be used to satisf y the Pharmaceutical MACT standards [40 CFR 63.1259(a)(3)], Offsite Waste MACT stan dards [40 CFR 63.697(b)(3)] and PSD BACT requirements [326 IAC 2-1.1-11].

(a) Pursuant to 40 CFR 63.6(e)(3), the Permi ttee shall develop an SSM Plan to ensure that processes are operated and maintained in a manner which satisfies the general duty to minimize emissions established by 40 CFR 63.6(e)(1)(i), and that all malfunctions are corrected as soon as practicable after thei r occurrence in order to minimize excess emissions. The SSM Plan shall contain the following information:

(1) Detailed plans and/or procedures for operating and maintaining the process during periods of SSM; and

(2) Corrective action program for malfunctioning processes.

(b) The startup, shutdown and malfunction ( SSM) requirements for the RTO control system or T79 control system, and associated closed -vent systems, are described in Sections D.14 and D.15 of this permit, respectively.

Testing and Monitoring Requirements [326 IAC 2-7-6(1) (6)] [326 IAC 2-7-5(1)]

D.7.6 Requirements

(a) The requirements for the RTO control sy stem and T79 control system, and associated closed-vent systems, used to control emission s from the emission units listed in this section are described in Sections D.14 and D.15 of this permit, respectively.

(b) The following streamlined requirements for t he solvent recovery columns that treat offsite waste shall satisfy the Offsite Waste MACT standards [40 CFR 63.684(d) and (e)] and the PSD BACT requirements [326 IAC 2-1.1-11]:Eli Lilly and Company-Tippecanoe Labs 4 th Significant Permit Modifica tion No. 157-22717-00006 Page 73 of 226 Lafayette, Indiana Modified by: Aida De Guzman OP No. T157-6879-00006 Permit Reviewer: Dr. Trip Sinha

(1) An initial and annual demonstration shall be performed within 30 days after first time an owner or operator begins using the treatment process to manage a new off-site material stream equal to or greater than 500 ppmw VOHAP or VOC in accordance with the requirements of eit her § 63.683(b)(1)(ii) or § 63.683(b)(2)(ii).

(2) The Permittee shall establish solvent recovery column temperature limits for each off-site waste material stream equal to or greater than 500 ppmw VOHAP or VOC. The Permittee shall monitor the temperature as follows:

(A) The Permittee shall install and operate the temperature CMS in accordance with 40 CFR 63.8(c).

(B) Each CMS shall be in continuous operation when the solvent recovery column is receiving off-site waste streams equal to or greater than 500 ppmw VOHAP or VOC, except for syst em malfunctions (breakdowns, out of control periods, and associated repairs), maintenance periods, calibration checks and zero (low-level) and high-level calibration drift adjustments.

(C) Continuous operation is defined as the collection of at least one measurement for each successive 15-minute period.

D.7.7 Monitoring Requirements

The monitoring requirements for the RTO contro l system and T79 control system, and associated closed-vent systems, used to control emissions from the applicable emission units listed in this section are described in Sections D.14 and D.15 of this permit, respectively.

Record Keeping and Reporting Requirements [326 IAC 2-7-5(3) and 326 IAC 2-7-19]

D.7.8 Record Keeping and Reporting Requirements

(a) Record Keeping Requirements

(1) RTO Control System and T79 Control System Records - The record keeping requirements for the RTO control system and T79 control system, and associated closed-vent systems, used to control emissions from the emission units listed in this section are described in Sections D.14 and D.15 of this permit, respectively.

(2) LDAR Records - The record keeping requirements for the LDAR standards are described in Sections E.1 and E.2 of this permit.

(3) Process Records – The Permittee shall maintain the following records:

(A) Daily rolling annual total HAP emissions;

(B) Number of batches per year for each batch process;

(C) Standard batch uncontrolled and contro lled emissions for each process;

(D) Actual uncontrolled and contro lled emissions for each nonstandard batch; and

(E) Record whether each batch operated was considered a standard batch.

(4) Solvent Recovery Records – The Permittee shall track how the solvent recovery columns are being utilized in an operating scenario maintained in the On-SiteEli Lilly and Company-Tippecanoe Labs 4 th Significant Permit Modifica tion No. 157-22717-00006 Page 74 of 226 Lafayette, Indiana Modified by: Aida De Guzman OP No. T157-6879-00006 Permit Reviewer: Dr. Trip Sinha

Implementation Log. If a solvent recovery column is used as a treatment column for offsite waste, then the Permittee shall maintain the following records:

(A) Initial and annual demonstration records;

(B) Records of all required CMS data;

(C) Records of each CMS calibration checks;

(D) Maintenance records for each CMS; and

(E) Occurrence/duration records of each CMS malfunction.

(5) Heat Exchange System Records - Maint enance records, including the date, time, and sign off or initials of the individual who completed the task, of all heat exchange systems that use water to cool process equipment or materials used in pharmaceutical manufacturing operations. The Permittee shall track the heat exchange systems that use water to cool process equipment or materials used in pharmaceutical manufacturing operations in an operating scenario maintained in the On-Site Implementation Log (OSIL).

(6) SSM Records - The Permittee shall maintain the following records:

(A) Records of the current and superseded versions of SSM Plan.

(B) Occurrence/duration records of each process malfunction.

(C) Information to demonstrate conformance with each SSM are consistent with the procedures in the SSM Plan.

(D) Records of actions taken during each SSM when different from SSM

Plan.

(7) All records shall be maintained in accordance with Section C - General Record Keeping Requirements, of this permit.

(b) Periodic Reporting Requirements

(1) The following streamlined quarterly reporting requirements shall satisfy the Pharmaceutical MACT standards [40 CF R 63.1256(b)], Offsite Waste MACT [40 CFR 63.697(b)(3)] and the PSD BACT requirements [326 IAC 2-1.1-11]:

(A) SSM summary reports for the processes.

(B) The reporting requirements for the RTO control system, T79 fume incinerator control system, and asso ciated closed-vent systems that

control emissions from the emission units listed in this section are described in Sections D.14 and D.15 of this permit, respectively.

(C) The reporting requirements for t he LDAR standards are described in Sections E.1 and E.2 of this permit.

(c) Immediate Reporting Requirements

The reporting requirements in the NESHAP G eneral Provisions for Startup, Shutdown and Malfunction (SSM) Plans [40 CFR 63.6(e)(3 )] shall be used to satisfy the reporting requirements under the Pharmaceutical MACT standards [40 CFR 63.1259(a)(3)], Offsite Waste MACT standards [40 CFR 63.697(b)(3 ), and PSD BACT requirements [326 IAC 2- 1.1-11].Eli Lilly and Company-Tippecanoe Labs 4 th Significant Permit Modifica tion No. 157-22717-00006 Page 75 of 226 Lafayette, Indiana Modified by: Aida De Guzman OP No. T157-6879-00006 Permit Reviewer: Dr. Trip Sinha

(1) Any time an action taken by the Permi ttee during an SSM event of a process is not consistent with the procedures specified in the SSM Plan, the Permittee shall report the actions taken for that event. The immediate report shall be submitted to the agency via a telephone call or facsimile within 2 working days after commencing actions inconsistent with the plan.

(2) Within 7 working days after the end of an SSM event of a process where an action taken by the Permittee is not consis tent with the procedures specified in the SSM Plan, the Permittee shall submit a letter containing the following information in accordance with 40 CFR 63.10(d)(5):

(A) Name, title and signature of respon sible official certifying accuracy;

(B) Explanation of the circ umstances of the event;

(C) Reason for not following the SSM Plan; and

(D) Report any excess emissions and/ or parameter monitoring exceedances

are believed to have occurred.

Modifications and Construction Requirements [326 IAC 2-7-10.5, 326 IAC 2-7-12 and 326 IAC 2-2]

D.7.9 Modifications and Construction: Ad vance Approval of Permit Conditions

(a) The Permittee may modify any existing emissi on units listed in this section of the permit without obtaining a source m odification approval (otherwise required by 326 IAC 2-7- 10.5), a Title V permit modification (otherwise required by 326 IAC 2-7-12), or a Prevention of Significant Deterioration permit (otherwise required by 326 IAC 2-2), provided the modified emission units are s ubject to the same applicable requirements listed in this D section, and the Permittee shall comply with the Change Management and Flexible Permit provisions in Section F.1 of this permit.

(b) The Permittee may construct and install new em ission units of the types described in this D section without obtaining a source modifica tion approval (otherwise required by 326 IAC 2-7-10.5), a Title V permit modification (otherwise required by 326 IAC 2-7-12), or a Prevention of Significant Deterioration permit (otherwise required by 326 IAC 2-2), provided the new emission units are subject to the same applicable requirements listed in this D section, and the Permittee shall comply with the Change Management and Flexible Permit provisions in Section F.1 of this permit.Eli Lilly and Company-Tippecanoe Labs 4 th Significant Permit Modifica tion No. 157-22717-00006 Page 76 of 226 Lafayette, Indiana Modified by: Aida De Guzman OP No. T157-6879-00006 Permit Reviewer: Dr. Trip Sinha

SECTION D.8 BPM SUPPORT OPERATIONS – INDIVIDUAL DRAIN SYSTEM CONDITIONS

Facility Description [326 IAC 2-7-5(15)]

The information describing the pr ocesses contained in the following facility description boxes is descriptive information and does not constitute enforceable conditions:

The emission units listed below are subject to applicable requirements described or referred to in this D section. These sumps are defined as individual dr ain systems under the Nati onal Emission Standards of

Hazardous Air Pollutants for Pharmaceutical Produc tion Operations (Pharmaceutical MACT) found at 40 CFR 63, Subpart GGG.

Unit ID Unit Description Stack/Vent Nominal Capacity Control

Device

Building T27:

T27-Sump* Sump Tank/Lift Station RTO 2000 gal RTO

Building T28:

T28-Sump* Sump RTO 1300 gal RTO

Building T31:

T31-Sump* Sump RTO 5900 gal RTO

Building T31A:

T31A-Sump* Sump RTO 300 gal RTO
Building T19: T19-1-Sump* Sump None None
Building T149: T149-TK782* IDS None 100 gal None

* Emission units marked with an asterisk are insignificant activities as defined by 326 IAC 2-7-1(21)(A)-(C).

Emission Limitations and Sta ndards [326 IAC 2-7-5(1)]

D.8.1 BPM Individual Drain System (IDS) Standar ds [40 CFR 63.1256(e), 40 CFR 63.689(b), and 326 IAC 2-2-3]

The following streamlined standards for BPM IDSs satisfy the requirements of the Pharmaceutical MACT Standards for individual drain system s [40 CFR 63.1256(e)], OSWRO MACT Standards for transfer systems [40 CFR 63.689(b)], and PSD BACT requirements [326 IAC 2-2-3]:

(a) Definition Standards:

(1) A BPM IDS is defined as any stationar y system used to c onvey waste streams containing HAP or VOC to a waste management unit. A segregated stormwater sewer system, which is a drain and colle ction system designed and operated for the sole purpose of collecting rainfall-run off at a facility, and which is segregated from all other individual drain systems, is excluded from this definition. An IDS that is used for the sole purpose of collecting wastewater from drips, spills and leaks, or water from safety showers, condensation and fire deluge systems, is excluded from this definition. For purpos es of inspections in Section D.8.1(c), a BPM IDS includes any fixed roof, cover, and/or enclosure, and closed vent system section from the IDS to the in let of the production building roof fan exhausting to the control device or to the IDS conservation vent.Eli Lilly and Company-Tippecanoe Labs 4 th Significant Permit Modifica tion No. 157-22717-00006 Page 77 of 226 Lafayette, Indiana Modified by: Aida De Guzman OP No. T157-6879-00006 Permit Reviewer: Dr. Trip Sinha

(b) Operational Standards:

(1) The Permittee shall cover the openings of each operating BPM IDS containing waste equal to or greater than 500 parts per million by weight (ppmw) HAP and/or 500 ppmw VOC at all times during us e except when it is necessary to use the opening for sampling or removal of material, or for equipment inspection, maintenance, or repair; and

(2) Except as otherwise provided in this Condition, the emissi on limits and standards for each operating BPM IDS containing waste equal to or greater than 500 ppmw HAP and/or 500 ppmw VOC are described in SECTION D.14 for emission units controlled by the RTO control system and described in SECTION D.15 for emission units controlled by the T79 fume incinerator control system; or

(3) For each BPM IDS equipped with a water seal, the Permittee is not subject to the requirements in (1) and (2) of this section, but instead shall ensure that the water seal is maintained on a semiannual basis. For example, a flow-monitoring device indicating positive flow from a main to a branch water line supplying a trap or water being continuously dripped into the trap by a hose could be used to verify flow of water to the trap. Visual observ ation is also an acceptable alternative.

(c) Inspection Standards:

(1) For each BPM IDS containing waste equal to or greater than 500 ppmw HAP and/or 500 ppmw VOC, the Permittee shall perform the following visual inspections and, when necessary, comply with the following repair requirements:

(A) Initial and semiannual visual inspections of each BPM IDS for improper work practices such as leaving open any access hatch or other opening when such hatch or opening is not in use for sampling or removal, or for equipment inspection, maintenance, or repair.

(B) Initial and semiannual visual inspections of each BPM IDS for control equipment failures such as a cracked or broken joint, lid, cover, or door.

(C) Initiate repair of any leak no later than 5 calendar days after identification, and complete repair wi thin 15 days after identification, except for the following allowances for delay of repair:

(i) Repair is technically in feasible without a shutdown;

(ii) Emissions resulting from imm ediate repair would be greater than the emissions likely to result from delay of repair. In such cases, repair shall occur by the end of the next shutdown;

(iii) Equipment is emptied or is no longer used to treat waste equal to or greater than 500 ppmw HAP and/or VOC; or

(iv) Unavailability of parts beyo nd the control of the Permittee.

(2) For each BPM IDS containing waste equal to or greater than 500 ppmw HAP and/or 500 ppmw VOC and not operated under negative pressure, the Permittee shall perform the following additional inspections and, when necessary, comply with the following repair requirements:

(A) Initial one-time Method 21 inspection on the cover of each BPM IDS. For new equipment, this inspection shall be performed within 150 days upon startup of the new equipment.Eli Lilly and Company-Tippecanoe Labs 4 th Significant Permit Modifica tion No. 157-22717-00006 Page 78 of 226 Lafayette, Indiana Modified by: Aida De Guzman OP No. T157-6879-00006 Permit Reviewer: Dr. Trip Sinha

(B) Semiannual visual inspections for visible, audible, or olfactory indications

of leaks.

(C) Initiate repair of any leak no later than 5 calendar days after identification, and complete repair wi thin 15 days after identification, except for the following situations:

(i) Delay of repair is allowed if the repair is technically infeasible without a shutdown; or

(ii) Delay of repair is allowed if the emissions resulting from immediate repair would be greater than the emissions likely to result from delay of repair.

(3) For each BPM IDS equipped with a water seal, the Permittee is not subject to the requirements in (1) and (2) of this section, but instead shall ensure that the water seal is maintained on a semiannual basis. For example, a flow-monitoring device indicating positive flow from a main to a branch water line supplying a trap or water being continuously dripped into the trap by a hose could be used to verify flow of water to the trap. Visual observ ation is also an acceptable alternative.

(4) BPM IDSs containing waste equal to or greater than 500 ppmw HAP and/or 500 ppmw VOC that are unsafe or difficult to inspect are not subject to the requirements of D.8.1 (b)(2) and D.8.1(c).

D.8.2 Startup, Shutdown and Malfunc tion Requirements [40 CFR 63.125 9(a)(3), 40 CFR 63.697(b)(3), 326 IAC 2-2-3, 40 CFR 63.6(e) and 40 CFR 63.8(c)]

The NESHAP General Provisions for Startup, Shutdown and Malfunction (SSM) Plans [40 CFR 63.6(e) and 63.8(c)] shall be used to satisf y the Pharmaceutical MACT standards [40 CFR 63.1259(a)(3)], Offsite Waste MACT stan dards [40 CFR 63.697(b)(3)] and PSD BACT requirements [326 IAC 2-1.1-11].

(a) Pursuant to 40 CFR 63.6(e)(3), the Permi ttee shall develop an SSM Plan to ensure that processes are operated and maintained in a manner which satisfies the general duty to minimize emissions established by 40 CFR 63.6(e)(1)(i), and that all malfunctions are corrected as soon as practicable after thei r occurrence in order to minimize excess emissions. The SSM Plan shall contain the following information:

(1) Detailed plans and/or procedures for operating and maintaining the process during periods of SSM; and

(2) Corrective action program for malfunctioning processes.

(b) The startup, shutdown and malfunction ( SSM) requirements for the RTO control system or T79 control system, are described in Sections D.14 and D.15 of this permit, respectively.

Testing and Monitoring Requirements [326 IAC 2-7-6(1) (6)] [326 IAC 2-7-5(1)]

D.8.3 Requirements

(a) The compliance determination requirements for the RTO control system and T79 fume incinerator control system, and associated closed-vent systems, used to control

emissions from the emission units listed in this section are described in Sections D.14 and D.15 of this permit, respectively.Eli Lilly and Company-Tippecanoe Labs 4 th Significant Permit Modifica tion No. 157-22717-00006 Page 79 of 226 Lafayette, Indiana Modified by: Aida De Guzman OP No. T157-6879-00006 Permit Reviewer: Dr. Trip Sinha

(b) The Permittee shall utilize engineering knowledge of the waste stream constituents such

as material balances to demonstrate th e average VOHAP and/or VOC concentration is less than 500 ppmw for each BPM IDS that is not controlled in accordance with D.8.3 (a).

D.8.4 Monitoring Requirements

The monitoring requirements for the RTO control system and T79 fume incinerator control system, and associated closed-vent systems, used to control emissions from the emission units
listed in this section are described in Sectio ns D.14 and D.15 of this permit, respectively.

Record Keeping and Reporting Requirements [ 326 IAC 2-7-10.5, 326 IAC 2-7-12 and 326 IAC 2-2]

D.8.5 Record Keeping and Reporting Requirements

(a) Record Keeping Requirements

(1) RTO Control System and T79 Control System Records - The record keeping requirements for the RTO control system and T79 fume incinerator control system, and associated clos ed-vent systems that cont rol emissions from the

emission units listed in this section are described in Sections D.14 and D.15 of this permit, respectively.

(2) Inspection and Maintenance Records - The Permittee shall maintain the following

records:

(A) Identification and explanation of all BPM IDS covers unsafe to inspect, including a plan for when these IDS covers will be inspected;

(B) Identification and explanation of all BPM IDS covers difficult to inspect, including a plan for when these IDS covers will be inspected;

(C) Visual inspection log of BPM IDSs, including the date of inspection and a

statement that no leaks were detected, if applicable;

(D) One-time Method 21 inspection log of each BPM IDS cover, including the date of inspection and a statement that no leaks were detected, if applicable;

(E) Information on each BPM IDS cover inspection during which a leak is detected, including:

(i) Instrument identification number s, operator name or initials, and identification of the equipment;

(ii) Date the leak was detected and the date of the first attempt to repair the leak;

(iii) Maximum instrument reading measured after leak is successfully repaired or determined to be nonrepairable;

(iv) Reason for any delay of repair if leak not repaired within 15 calendar days after discovery of the leak;

(v) Name, initials, or other form of identification of person whose decision it was that repair could not be effected without a shutdown;Eli Lilly and Company-Tippecanoe Labs 4 th Significant Permit Modifica tion No. 157-22717-00006 Page 80 of 226 Lafayette, Indiana Modified by: Aida De Guzman OP No. T157-6879-00006 Permit Reviewer: Dr. Trip Sinha

(vi) Expected date of successful r epair of leak if leak not required within 15 calendar days after discovery of leak;

(vii) Dates of shutdowns that occur while the equipment is unrepaired; and

(viii) Date of successful repair of the leak.

(F) Documentation of a decision to use a delay of repair due to unavailability of parts shall include a description of the failure, the reason additional time was necessary (including a st atement of why replacement parts were not kept onsite and when deliv ery from the manufacturer is scheduled), and the date when the repair was completed.

(3) SSM Records - The Permittee shall maintain the following records:

(A) Records of the current and superseded versions of SSM Plan.

(B) Occurrence/duration records of each process malfunction.

(C) Information to demonstrate conformance with each SSM are consistent wit the procedures in the SSM Plan.

(D) Records of actions taken during each SSM when different from SSM

Plan.

(4) IDS Waste Stream Records - The Permittee shall identify each IDS not controlled by the RTO or T79 control system and maintain documentation to support the average waste stream constituents of VO HAP and/or VOC concentration are less than 500 ppmw.

(b) Periodic Reporting Requirements

(1) The following streamlined quarterly reporting requirements shall satisfy the

Pharmaceutical MACT standards [40 CFR 63.1256(b)] and the PSD BACT requirements [326 IAC 2-1.1-11]:

(A) Inspections conducted during which a leak was detected; and

(B) SSM summary reports for the processes.

(C) The reporting requirements for the RTO control system, T79 fume incinerator control system, and asso ciated closed-vent systems that

control emissions from the emission units listed in this section are described in Sections D.14 and D.15 of this permit, respectively.

(c) Immediate Reporting Requirements

The reporting requirements in the NESHAP G eneral Provisions for Startup, Shutdown and Malfunction (SSM) Plans [40 CFR 63.6(e)(3 )] shall be used to satisfy the reporting requirements under the Pharmaceutical MACT standards [40 CFR 63.1259(a)(3)], Offsite Waste MACT standards [40 CFR 63.697(b)(3 ), and PSD BACT requirements [326 IAC 2- 1.1-11].

(1) Any time an action taken by the Permi ttee during an SSM event of a process is not consistent with the procedures specified in the SSM Plan, the Permittee shall report the actions taken for that event. The immediate report shall be submitted to the agency via a telephone call or facsimile within 2 working days after commencing actions inconsistent with the plan.Eli Lilly and Company-Tippecanoe Labs 4 th Significant Permit Modifica tion No. 157-22717-00006 Page 81 of 226 Lafayette, Indiana Modified by: Aida De Guzman OP No. T157-6879-00006 Permit Reviewer: Dr. Trip Sinha

(2) Within 7 working days after the end of an SSM event of a process where an action taken by the Permittee is not consis tent with the procedures specified in the SSM Plan, the Permittee shall submit a letter containing the following information in accordance with 40 CFR 63.10(d)(5):

(A) Name, title and signature of respon sible official certifying accuracy;

(B) Explanation of the circ umstances for the event;

(C) Reason for not following the SSM Plan; and

(D) Report any excess emissions and/ or parameter monitoring exceedances

are believed to have occurred.

Modifications and Construction Requirements [326 IAC 2-7-10.5, 326 IAC 2-7-12 and 326 IAC 2-2]

D.8.6 Modifications and Construction: Ad vance Approval of Permit Conditions

(a) The Permittee may modify any existing emissi on units listed in this section of the permit without obtaining a source modification appr oval (otherwise required by 326 IAC 2-7- 10.5), a Title V permit modification (otherwise required by 326 IAC 2-7-12), or a Prevention of Significant Deterioration permit (otherwise required by 326 IAC 2-2), provided the modified emission units are s ubject to the same applicable requirements listed in this D section, and the Permittee shall comply with the Change Management and Flexible Permit provisions in Section F.1 of this permit.

(b) The Permittee may construct and install new em ission units of the types described in this D section without obtaining a source modifica tion approval (otherwise required by 326 IAC 2-7-10.5), a Title V permit modification (otherwise required by 326 IAC 2-7-12), or a Prevention of Significant Deterioration permit (otherwise required by 326 IAC 2-2), provided the new emission units are subject to the same applicable requirements listed in this D section, and the Permittee shall comply with the Change Management and Flexible Permit provisions in Section F.1 of this permit.

Non-Applicability of Requirements

D.8.7 Non-Applicability Determ inations [326 IAC 8-5-3]

The control requirements of the Synthesized Pharmaceutical RACT rules (326 IAC 8-5-3) do not apply to the individual drain systems identified abov e in the Facility Description section because the potential to emit VOC emissions from each fac ility is less than the rule applicability threshold level of 6.8 kilograms per day (15 pounds per day).Eli Lilly and Company-Tippecanoe Labs 4 th Significant Permit Modifica tion No. 157-22717-00006 Page 82 of 226 Lafayette, Indiana Modified by: Aida De Guzman OP No. T157-6879-00006 Permit Reviewer: Dr. Trip Sinha

SECTION D.9 BPM SUPPORT OPERATIONS – SOLVENT STORAGE TANK CONDITIONS

Facility Description [326 IAC 2-7-5(15)]

The information describing the pr ocesses contained in the following facility description boxes is descriptive information and does not constitute enforceable conditions:

Emission

Unit ID Emission Unit Description Stack/Vent Nominal Capacity Control

Device

Building T143 – Tank Module:

T143-TK01 Solvent Tank T79 Incinerator 38,245 gal T79 Incinerator

T143-TK03 Solvent Tank T79 Incinerator 38,245 gal T79 Incinerator

T143-TK05 Solvent Tank T79 Incinerator 38,245 gal T79 Incinerator

T143-TK07 Solvent Tank T79 Incinerator 38,245 gal T79 Incinerator

T143-TK09 Solvent Tank T79 Incinerator 38,245 gal T79 Incinerator

T143-TK11 Solvent Tank T79 Incinerator 38,245 gal T79 Incinerator

T143-TK12 Solvent Tank T79 Incinerator 19,500 gal T79 Incinerator

T143-TK13 Solvent Tank T79 Incinerator 19,500 gal T79 Incinerator

T143-TK14 Solvent Tank T79 Incinerator 19,500 gal T79 Incinerator

T143-TK17 Solvent Tank T79 Incinerator 19,500 gal T79 Incinerator

T143-TK18 Solvent Tank T79 Incinerator 19,500 gal T79 Incinerator

T143-TK19 Solvent Tank T79 Incinerator 19,500 gal T79 Incinerator

T143-TK20 Solvent Tank T79 Incinerator 19,500 gal T79 Incinerator

T143-TK21 Solvent Tank T79 Incinerator 19,500 gal T79 Incinerator

T143-TK22 Solvent Tank T79 Incinerator 19,500 gal T79 Incinerator

T143-TK23 Solvent Tank T79 Incinerator 19,500 gal T79 Incinerator

T143-TK24 Solvent Tank T79 Incinerator 19,500 gal T79 Incinerator

Building T145 – Tank Module:

T145-TK25 Solvent Tank T79 Incinerator 18,900 gal T79 Incinerator

T145-TK26 Solvent Tank T79 Incinerator 18,900 gal T79 Incinerator

T145-TK27 Solvent Tank T79 Incinerator 18,900 gal T79 Incinerator

T145-TK28 Solvent Tank T79 Incinerator 18,900 gal T79 Incinerator

T145-TK29 Solvent Tank T79 Incinerator 18,900 gal T79 Incinerator

T145-TK30 Solvent Tank T79 Incinerator 18,900 gal T79 Incinerator

T145-TK31 Solvent Tank T79 Incinerator 18,900 gal T79 Incinerator

T145-TK32 Solvent Tank T79 Incinerator 18,900 gal T79 Incinerator

T145-TK33 Solvent Tank T79 Incinerator 18,900 gal T79 Incinerator

T145-TK34 Solvent Tank T79 Incinerator 18,900 gal T79 Incinerator

T145-TK35 Solvent Tank T79 Incinerator 18,900 gal T79 Incinerator

T145-TK36 Solvent Tank T79 Incinerator 18,900 gal T79 Incinerator

T145-TK37 Solvent Tank T79 Incinerator 18,900 gal T79 IncineratorEli Lilly and Company-Tippecanoe Labs 4 th Significant Permit Modifica tion No. 157-22717-00006 Page 83 of 226 Lafayette, Indiana Modified by: Aida De Guzman OP No. T157-6879-00006 Permit Reviewer: Dr. Trip Sinha

Emission

Unit ID Emission Unit Description Stack/Vent Nominal Capacity Control

Device

T145-TK38 Solvent Tank T79 Incinerator 18,900 gal T79 Incinerator

T145-TK39 Solvent Tank T79 Incinerator 18,900 gal T79 Incinerator

T145-TK40 Solvent Tank T79 Incinerator 18,900 gal T79 Incinerator

T145-TK41 Solvent Tank T79 Incinerator 18,900 gal T79 Incinerator

T145-TK42 Solvent Tank T79 Incinerator 18,900 gal T79 Incinerator

T145-TK43 Solvent Tank T79 Incinerator 18,900 gal T79 Incinerator

T145-TK44 Solvent Tank T79 Incinerator 18,900 gal T79 Incinerator

T145-TK45 Solvent Tank T79 Incinerator 18,900 gal T79 Incinerator

T145-TK46 Solvent Tank T79 Incinerator 18,900 gal T79 Incinerator

T145-TK47 Solvent Tank T79 Incinerator 18,900 gal T79 Incinerator

T145-TK48 Solvent Tank T79 Incinerator 18,900 gal T79 Incinerator

T145-TK49 Solvent Tank T79 Incinerator 18,900 gal T79 Incinerator

T145-TK50 Solvent Tank T79 Incinerator 10,000 gal T79 Incinerator

T145-TK51 Solvent Tank T79 Incinerator 10,000 gal T79 Incinerator

T145-TK52 Solvent Tank T79 Incinerator 10,000 gal T79 Incinerator

T145-TK53 Solvent Tank T79 Incinerator 10,000 gal T79 Incinerator

T145-TK54 Solvent Tank T79 Incinerator 10,000 gal T79 Incinerator

T145-TK55 Solvent Tank T79 Incinerator 10,000 gal T79 Incinerator

T145-TK56 Solvent Tank T79 Incinerator 10,000 gal T79 Incinerator

T145-TK57 Solvent Tank T79 Incinerator 10,000 gal T79 Incinerator

T145-TK58 Solvent Tank T79 Incinerator 10,000 gal T79 Incinerator

T145-TK59 Solvent Tank T79 Incinerator 10,000 gal T79 Incinerator

Building T146 – Tank Module:

T146-TK01 Solvent Tank RTO 19,500 gal RTO

T146-TK02 Solvent Tank RTO 19,500 gal RTO

T146-TK03 Solvent Tank RTO 19,500 gal RTO

T146-TK04 Solvent Tank RTO 19,500 gal RTO

T146-TK05 Solvent Tank RTO 19,500 gal RTO

T146-TK06 Solvent Tank RTO 19,500 gal RTO

T146-TK07 Solvent Tank RTO 19,500 gal RTO

T146-TK08 Solvent Tank RTO 19,500 gal RTO

T146-TK09 Solvent Tank RTO 19,500 gal RTO

T146-TK10 Solvent Tank RTO 19,500 gal RTO

T146-TK13 Solvent Tank RTO 19,000 gal RTO

T146-TK14 Solvent Tank RTO 19,000 gal RTO

T146-TK15 Solvent Tank RTO 19,000 gal RTO

T146-TK16 Solvent Tank RTO 19,000 gal RTO

T146-TK17 Solvent Tank RTO 19,000 gal RTOEli Lilly and Company-Tippecanoe Labs 4 th Significant Permit Modifica tion No. 157-22717-00006 Page 84 of 226 Lafayette, Indiana Modified by: Aida De Guzman OP No. T157-6879-00006 Permit Reviewer: Dr. Trip Sinha

Emission

Unit ID Emission Unit Description Stack/Vent Nominal Capacity Control

Device

T146-TK18 Solvent Tank RTO 19,000 gal RTO

T146-TK19 Solvent Tank RTO 19,000 gal RTO

T146-TK22 Solvent Tank RTO 19,000 gal RTO

Building T64:

T64-TK2 Phenol Storage Tank RTO 10,000 gal RTO

Emission Limitations and Sta ndards [326 IAC 2-7-5(1)]

D.9.1 Standards for BPM Solvent Storage Tanks [40 CFR 63.1253(c)(1) (i), 40 CFR 60.112b and 60.113b, 326 IAC 8-5-3, and 326 IAC 2-2]

The following streamlined standards for the BPM solvent storage tanks satisfy the requirements
of the Pharmaceutical MACT Standards for stor age tanks [40 CFR 63.1253(c)(1)(i)], Volatile Organic Liquid Storage Vessel Standards [40 CFR 60.112b and 60.113b], PSD BACT requirements [326 IAC 2-2-3] and RACT requi rements for synthesized pharmaceutical manufacturing operations [326 IAC 8-5-3]:

(a) Definition Standards:

(1) A BPM solvent storage tank is defined as any vessel designed to store raw

material feedstocks or used solvent to be recovered that contain VOCs and/or VOHAP. Pressure vessels greater t han 204.9 kPa without emissions to the atmosphere, vessels attached to motor vehicles, or vessels used to store beverage alcohol are not BPM solvent storage tanks. For purposes of inspections in Section D.9.1(c), a BPM so lvent storage tank includes any fixed roof, cover, and/or enclosure, and closed vent system section from the BPM solvent storage tank to the inlet of the production building roof fan exhausting to the control device or to the BPM solvent storage tank conservation vent.

(b) Operational Standards:

(1) Except as otherwise provided in this Condition and in Condition D.9.2, the Permittee shall route the vapors from ea ch operating BPM solvent storage tank through a closed-vent system to either the RTO control system or the T79 fume incinerator control system, which are described in Section D.14 for equipment controlled by the RTO control system and described in Section D.15 for equipment controlled by the T79 fume incinerator control system.

(2) Solvent storage tanks shall be of fixed-roof design.

(c) Inspection Standards:

(1) The Permittee shall conduct one-time Method 21 inspections of the fixed roof for each existing BPM solvent storage tank not operated under negative pressure and not already subject to LDAR within 150 days of the issuance date of this permit, and for each new BPM solvent stor age tank not operated under negative pressure and not subject to LDAR within 150 days upon startup.

(2) The Permittee shall conduct semiannual visual inspections on each BPM solvent storage tank for visible, audible, or olfactory indications of leaks.Eli Lilly and Company-Tippecanoe Labs 4 th Significant Permit Modifica tion No. 157-22717-00006 Page 85 of 226 Lafayette, Indiana Modified by: Aida De Guzman OP No. T157-6879-00006 Permit Reviewer: Dr. Trip Sinha

(3) The Permittee shall initiate repair of any leak on a BPM solvent storage tank no later than 5 calendar days after identificat ion, and complete the repair within 15 days after identification, unless:

(i) The repair is technically infeasible without a shutdown of an operation or

process; or

(ii) It is determined that emissions resulting from immediate repair would be greater than the fugitive emissions likely to result from delay or repair.

Repairs delayed due to either of the caus es described in (A) or (B) shall be completed by the end of the next shutdown.

D.9.2 Exceptions to Standards for BPM Solvent Storage Tanks [40 CFR 63.1253 and 326 IAC 2-2]

(a) The BPM solvent storage tanks are not subj ect to the standards established in Condition D.9.1 (b) during periods of planned routine ma intenance, as long as the planned routine maintenance activities do not exceed 240 hours per 365 day period.

(b) BPM solvent storage tanks storing VOC/VOHAP with a vapor pressure less than 3.5 kPa are not subject to the requirements of D.9.1 (b)(1) and (c).

(c) BPM solvent storage tanks that are unsafe or difficult to inspect are not subject to the requirements of D.9.1(c).

D.9.3 Leak Detection and Repair (LDAR) St andards [40 CFR 63.1255 and 326 IAC 2-2]

The LDAR standards that apply to components asso ciated with the emission units listed in this section are described in Section E.1 of this permit.

D.9.4 Startup, Shutdown and Malfunc tion Requirements [40 CFR 63.1259(a)(3), 326 IAC 2-2-3, 40 CFR 63.6(e) and 40 CFR 63.8(c)]

The NESHAP General Provisions for Startup, Shutdown and Malfunction (SSM) Plans [40 CFR 63.6(e) and 63.8(c)] shall be used to satisf y the Pharmaceutical MACT standards [40 CFR 63.1259(a)(3)], and PSD BACT requirements [326 IAC 2-1.1-11].

(a) Pursuant to 40 CFR 63.6(e)(3), the Permi ttee shall develop an SSM Plan to ensure that processes are operated and maintained in a manner which satisfies the general duty to minimize emissions established by 40 CFR 63.6(e)(1)(i), and that all malfunctions are corrected as soon as practicable after thei r occurrence in order to minimize excess emissions. The SSM Plan shall contain the following information:

(1) Detailed plans and/or procedures for operating and maintaining the process during periods of SSM; and

(2) Corrective action program for malfunctioning processes.

(b) The startup, shutdown and malfunction ( SSM) requirements for the RTO control system or T79 control system, are described in Sections D.14 and D.15 of this permit, respectively.Eli Lilly and Company-Tippecanoe Labs 4 th Significant Permit Modifica tion No. 157-22717-00006 Page 86 of 226 Lafayette, Indiana Modified by: Aida De Guzman OP No. T157-6879-00006 Permit Reviewer: Dr. Trip Sinha

Testing and Monitoring Requirements [326 IAC 2-7-6(1) (6)] [326 IAC 2-7-5(1)]

D.9.5 Requirements

The requirements for the RTO control system and T79 fume incinerator control system, and associated closed-vent systems t hat control emissions from the emission units listed in this section are described in Sections D.14 and D.15 of this permit, respectively.

D.9.6 Monitoring Requirements

The monitoring requirements for the RTO control system, T79 fume incinerator control system, and associated closed-vent systems t hat control emissions from the emission units listed in this section are described in Sections D.14 and D.15 of this permit, respectively.

Record Keeping and Reporting Requirements [326 IAC 2-7-10.5, 326 IAC 2-7-12, 326 IAC 2-2, 40 CFR 60.7, 40 CFR 60 Subpart Kb, and 40 CFR 63 Subpart GGG]

D.9.7 Record Keeping and Reporting Requirements

(a) Record Keeping Requirements

(1) The record keeping requirements fo r the RTO control system, T79 fume incinerator control system, and associat ed closed-vent systems that control

emissions from the emission units listed in this section are described in Sections D.14 and D.15 of this permit, respectively.

(2) Inspection and Maintenance Records - The Permittee shall maintain the following

records:

(A) Identification and explanation of all BPM solvent storage tanks unsafe to inspect, including a plan for when these tanks w ill be inspected;

(B) Identification and explanation of all BPM solvent storage tanks difficult to inspect, including a plan for when these tanks w ill be inspected;

(C) Visual inspection log of BPM solvent storage tanks, including the date of inspection and a statement that no leaks were detected, if applicable;

(D) One-time Method 21 inspection log of each BPM solvent storage tank, including the date of inspection an d a statement that no leaks were detected, if applicable;

(E) Information on each BPM solvent storage tank inspection during which a leak is detected, including:

(i) Instrument identification number s, operator name or initials, and identification of the equipment;

(ii) Date the leak was detected and the date of the first attempt to repair the leak;

(iii) Maximum instrument reading measured after leak is successfully repaired or determined to be nonrepairable;

(iv) Reason for any delay of repair if leak not repaired within 15 calendar days after discovery of the leak;Eli Lilly and Company-Tippecanoe Labs 4 th Significant Permit Modifica tion No. 157-22717-00006 Page 87 of 226 Lafayette, Indiana Modified by: Aida De Guzman OP No. T157-6879-00006 Permit Reviewer: Dr. Trip Sinha

(v) Name, initials, or other form of identification of person whose decision it was that repair could not be affected without a shutdown;

(vi) Expected date of successful r epair of leak if leak not required within 15 calendar days after discovery of leak;

(vii) Dates of shutdowns that occur while the equipment is unrepaired; and

(viii) Date of successful repair of the leak.

(F) Periods of planned routine maintenance; and

(G) Records of BPM solvent storage t anks storing VOC/VOHAP with a vapor pressure less than 3.5 kPa.

(3) SSM Records - The Permittee shall maintain the following records:

(A) Records of the current and superseded versions of SSM Plan.

(B) Occurrence/duration records of each process malfunction.

(C) Information to demonstrate conformance with each SSM is consistent with the procedures in the SSM Plan.

(D) Records of actions taken during each SSM when different from SSM

Plan.

(4) LDAR Records - The record keeping requirements for the LDAR standards are described in Section E.1 of this permit.

(5) Storage Tank Records - Pursuant to New Source Performance Standard for Volatile Organic Liquid Storage Vessels (40 CFR 60.116b(a) and (b)), the Permittee shall, for the life of the source , keep readily accessible records of the dimensions and capacity for each BPM solvent storage tank.

(6) Operating Plan – Pursuant to 40 CFR 60. 115b, the Permittee shall, for the life of the source, maintain a copy of the operating plan required by 40 CFR 60.113b for all tanks with design capacity greater than or equal to 75 cubic meters.

(b) Periodic Reporting Requirements

(1) The following streamlined quarterly reporting requirements shall satisfy the
Pharmaceutical MACT standards [40 CFR 63.1256(b)] and the PSD BACT requirements [326 IAC 2-1.1-11]:

(A) Semiannual visual inspections conducted during which a leak was detected;

(B) Periods of planned routine maintenance; and

(C) SSM summary reports for the processes.

(D) The reporting requirements for the RTO control system, T79 fume incinerator control system, and asso ciated closed-vent systems that

control emissions from the emission units listed in this section are described in Sections D.14 and D.15 of this permit, respectively.Eli Lilly and Company-Tippecanoe Labs 4 th Significant Permit Modifica tion No. 157-22717-00006 Page 88 of 226 Lafayette, Indiana Modified by: Aida De Guzman OP No. T157-6879-00006 Permit Reviewer: Dr. Trip Sinha

(E) The reporting requirements for t he LDAR standards are described in Section E of this permit.

(c) Immediate Reporting Requirements

The reporting requirements in the NESHAP G eneral Provisions for Startup, Shutdown and Malfunction (SSM) Plans [40 CFR 63.6(e)(3 )] shall be used to satisfy the reporting requirements under the Pharmaceutical MA CT standards [40 CFR 63.1259(a)(3)] and PSD BACT requirements [326 IAC 2-1.1-11].

(1) Any time an action taken by the Permi ttee during an SSM event of the process is not consistent with the procedures specified in the SSM Plan, the Permittee shall report the actions taken for that event. The immediate report shall be submitted to the agency via a telephone call or facsimile within 2 working days after commencing actions inconsistent with the plan.

(2) Within 7 working days after the end of an SSM event of the process where an action taken by the Permittee is not consis tent with the procedures specified in the SSM Plan, the Permittee shall submit a letter containing the following information in accordance with 40 CFR 63.10(d)(5):

(A) Name, title and signature of respon sible official certifying accuracy;

(B) Explanation of the circ umstances for the event;

(C) Reason for not following the SSM Plan; and

(D) Report any excess emissions and/ or parameter monitoring exceedances

are believed to have occurred.

Modifications and Construction Requirements [326 IAC 2-7-10.5, 326 IAC 2-7-12 and 326 IAC 2-2]

D.9.8 Modifications and Construction: Advance approval of permit conditions

(a) The Permittee may modify any existing emissi on units listed in this section of the permit without obtaining a source modification appr oval (otherwise required by 326 IAC 2-7- 10.5), a Title V permit modification (otherwise required by 326 IAC 2-7-12), or a Prevention of Significant Deterioration permit (otherwise required by 326 IAC 2-2), provided the modified emission units are s ubject to the same applicable requirements listed in this D section, and the Permittee shall comply with the Change Management and Flexible Permit provisions in Section F.1 of this permit.

(b) The Permittee may construct and install new em ission units of the types described in this D section without obtaining a source modifica tion approval (otherwise required by 326 IAC 2-7-10.5), a Title V permit modification (otherwise required by 326 IAC 2-7-12), or a Prevention of Significant Deterioration perm it (otherwise required by and 326 IAC 2-2), provided the new emission units are subject to the same applicable requirements listed in this D section, and the Permittee shall comply with the Change Management and Flexible Permit provisions in Section F.1 of this permit.Eli Lilly and Company-Tippecanoe Labs 4 th Significant Permit Modifica tion No. 157-22717-00006 Page 89 of 226 Lafayette, Indiana Modified by: Aida De Guzman OP No. T157-6879-00006 Permit Reviewer: Dr. Trip Sinha

SECTION D.10 BPM SUPPORT OPERAT IONS – WASTE TANK CONDITIONS

Facility Description [326 IAC 2-7-5(15)]

The information describing the pr ocesses contained in the following facility description boxes is descriptive information and does not constitute enforceable conditions:

Emission

Unit ID Emission Unit Description Stack/Vent Nominal Capacity Control

Device

Building T27:

T27-TK53-10* Waste Tank RTO 500 gal RTO

Building T28:

T28-TK-28HW* Waste Tank RTO 250 gal RTO
Building T29: T29-TK7902* Waste Tank RTO 1000 gal RTO
Building T31: T31-TK609* Waste Tank RTO 100 gal RTO T31-TK669* Waste Tank RTO 100 gal RTO
Building T31A: T31A-TK451K* Waste Tank RTO 100 gal RTO T31A-TK688* Waste Tank RTO 125 gal RTO
Building T99: T99-TK-1B* Waste Tank RTO 100 gal RTO T99-TK-7B* Waste Tank RTO 210 gal RTO T99-TK-8B* Waste Tank RTO 210 gal RTO T99-TK-D45A* Waste Tank RTO 100 gal RTO
Building T100: T100-TK-10A* Waste Tank RTO 200 gal RTO T100-TK-48* Waste Tank RTO 3300 gal RTO

Building T79:

T79-TK301* Equalization Tank T79 - 32 1 stream 50,000 gal T79 Incinerator

T79-TK302* Equalization Tank T79 - 32 1 stream 50,000 gal T79 Incinerator

T79-TK303* Neutralization Tank T79 - 321 stream 5,000 gal T79 Incinerator

Building T102-RTOs

T102-TK102 * 90 day RCRA Tank RTO 200 gal RTO

Tank Module Building T140:

T140-TK3122 Waste Tank T79 Incinerator 38,425 gal T79 Incinerator

T140-TK3123 Waste Tank T79 Incinerator 38,425 gal T79 Incinerator

T140-TK3124 Waste Tank T79 Incinerator 38,425 gal T79 Incinerator

T140-TK3125 Waste Tank T79 Incinerator 38,425 gal T79 Incinerator

T140-TK3126 Waste Tank T79 Incinerator 38,425 gal T79 Incinerator

T140-TK3227* Waste Tank T79 -324 stream 18,130 gal T79 Incinerator

T140-TK3228* Waste Tank T79 - 324 stream 18,130 gal T79 Incinerator

T140-TK3229* Waste Tank T79 - 32 4 stream 500 gal T79 Incinerator

Tank Module Building T142:

T142-TK01 Waste Tank T79 or RTO 19,500 gal T79 or RTOEli Lilly and Company-Tippecanoe Labs 4 th Significant Permit Modifica tion No. 157-22717-00006 Page 90 of 226 Lafayette, Indiana Modified by: Aida De Guzman OP No. T157-6879-00006 Permit Reviewer: Dr. Trip Sinha

Emission

Unit ID Emission Unit Description Stack/Vent Nominal Capacity Control

Device

T142-TK02 Waste Tank T79 or RTO 19,500 gal T79 or RTO

T142-TK03 Waste Tank T79 or RTO 19,500 gal T79 or RTO

T142-TK04 Waste Tank T79 or RTO 19,500 gal T79 or RTO

T142-TK05 Waste Tank T79 or RTO 19,500 gal T79 or RTO

T142-TK06 Waste Tank T79 or RTO 19,500 gal T79 or RTO

T142-TK07 Waste Tank T79 or RTO 19,500 gal T79 or RTO

T142-TK08 Waste Tank T79 or RTO 19,500 gal T79 or RTO

T142-TK09 Waste Tank T79 or RTO 19,500 gal T79 or RTO

T142-TK10 Waste Tank T79 or RTO 19,500 gal T79 or RTO

T142-TK11 Waste Tank T79 or RTO 19,500 gal T79 or RTO

T142-TK12 Waste Tank T79 or RTO 19,500 gal T79 or RTO

Tank Module Building T143:

T143-TK02* Waste Tank T79 - 325 stream 19,500 gal T79 Incinerator

T143-TK06* Waste Tank T79 - 325 stream 19,500 gal T79 Incinerator

T143-TK10* Waste Tank T79 - 325 stream 19,500 gal T79 Incinerator

T143-TK15* Waste Tank T79 - 325 stream 19,500 gal T79 Incinerator

T143-TK16 Waste Tank T79 Incinerator 19,500 gal T79 Incinerator T143-TK56* Knock Out Pot T79 Incinerator 45 gal T79 Incinerator

Tank Module Building T145:

T145-TK76* Knock Out Pot T79 Incinerator 45 gal T79 Incinerator T145-TK77* Knock Out Pot T79 Incinerator 45 gal T79 Incinerator

Tank Module Building T146:

T146-TK23 Waste Tank RTO 19,000 gal RTO

T146-TK24 Waste Tank RTO 19,000 gal RTO

T146-TK11* Waste Tank RTO 18,644 gal RTO

T146-TK20* Waste Tank RTO 18,644 gal RTO

T146-TK21* Waste Tank RTO 18,644 gal RTO

T146-TK12 Waste Tank RTO 19,500 gal RTO

T146-TK56* Knock Out Pot RTO 45 gal RTO

T48 Tank Farm:

T48-TK3207* Waste Tank T79 - 324 stream 102,759 gal T79 Incinerator

T48-TK3208* Waste Tank T79 - 324 stream 102,759 gal T79 Incinerator

T48-TK3209* Waste Tank T79 - 324 stream 102,759 gal T79 Incinerator

T48-TK3211* Waste Tank T79 - 324 stream 260,650 gal T79 Incinerator

T48-TK3212* Waste Tank T79 - 324 stream 260,650 gal T79 Incinerator

* Emission units marked with an asterisk are insignifican t activities as defined by 326 IAC 2-7-1(21)(A)-(C).Eli Lilly and Company-Tippecanoe Labs 4 th Significant Permit Modifica tion No. 157-22717-00006 Page 91 of 226 Lafayette, Indiana Modified by: Aida De Guzman OP No. T157-6879-00006 Permit Reviewer: Dr. Trip Sinha

Emission Limitations and Sta ndards [326 IAC 2-7-5(1)]

D.10.1 Standards for BPM Waste Storage Tanks [40 CFR 63.1256(b), 40 CFR 63.685, 40 CFR 60.110b, 326 IAC 2-2-3, and 326 IAC 8-5-3]

The following streamlined standards for BPM waste storage tanks satisfy t he requirements of the
Pharmaceutical MACT Standards for wastewater tanks [40 CFR 63.1256(b)], Volatile Organic Liquid Storage Vessel Standards [40 CFR 60.11 0b], OSWRO MACT Standards for waste tanks [40 CFR 63.685], PSD BACT requirements [326 IAC 2-2-3], and RACT requirements for synthesized pharmaceutical manufac turing operations [326 IAC 8-5-3]:

(a) Definition Standards:

(1) A BPM waste storage tank is defined as any waste management unit that is designed to contain an accumulation of waste material containing VOCs and/or VOHAP. Pressure vessels greater t han 204.9 kPa without emissions to the atmosphere or vessels attached to motor vehicles are not BPM waste storage tanks. For purposes of inspections in Section D.10.1(c), BPM waste storage tank includes any fixed roof, cover, and/or enclosure, and closed vent system section from the BPM waste storage tank to the in let of the production building roof fan exhausting to the control device or to the BPM waste storage tank conservation

vent.

(b) Operational Standards:

(1) Except as otherwise provided in this Condition and in Condition D.10.2, the Permittee shall route the vapors from each operating BPM waste storage tank through a closed-vent system to either the RTO control system or the T79 fume incinerator control system, which are described in Section D.14 for equipment controlled by the RTO control system and described in Section D.15 for equipment controlled by the T79 fume incinerator control system.

(2) BPM waste storage tanks sha ll be of fixed-roof design.

(c) Inspection Standards:

(1) The Permittee shall conduct one-time Method 21 inspections on each new fixed roof BPM waste storage tank not operated under negative pressure and not subject to LDAR within 150 days upon startup.

(2) The Permittee shall conduct semiannual visual inspections on the fixed roof and all openings of each BPM waste storage tank for visible, audible, or olfactory

indications of leaks.

(3) The Permittee shall initiate repair of any leak on a BPM waste storage tank no later than 5 calendar days after identificat ion, and complete the repair within 15 days after identification, unless:

(A) The repair is technically infeasible without a shutdown of an operation or

process; or

(B) It is determined that emissions resulting from immediate repair would be greater than the fugitive emissions likely to result from delay or repair. Repairs delayed due to either of the ca uses described in (A) or (B) shall be completed by the end of the next shutdown.Eli Lilly and Company-Tippecanoe Labs 4 th Significant Permit Modifica tion No. 157-22717-00006 Page 92 of 226 Lafayette, Indiana Modified by: Aida De Guzman OP No. T157-6879-00006 Permit Reviewer: Dr. Trip Sinha

D.10.2 Exceptions to Standards for BPM Waste Stor age Tanks [40 CFR 63.1256(b), 40 CFR 63, and 326 IAC 2-2-3]

(a) The BPM waste storage tanks less than 38 cubic meters are not subject to the standards established in Condition D.10.1 (b) during per iods of planned routine maintenance, as long as the planned routine maintenance acti vities do not exceed 240 hours per 365 day period.

(b) BPM waste storage tanks storing VOC/VOH AP with a vapor pressure less than 3.5 kPa are not subject to the requireme nts of D.10.1 (b)(1) and (c).

(c) BPM waste storage tanks that are unsafe or difficult to inspect are not subject to the requirements of D.10.1(c).

D.10.3 Leak Detection and Repair (LDAR) Standar ds [40 CFR 61, Subpart V and 326 IAC 2-2-3]

The LDAR standards that apply to components asso ciated with the BPM waste storage tanks are described in Section E.2 of this permit.

D.10.4 Startup, Shutdown and Malfunc tion Requirements [40 CFR 63.125 9(a)(3), 40 CFR 63.697(b)(3), 326 IAC 2-2-3, 40 CFR 63.6(e) and 40 CFR 63.8(c)]

The NESHAP General Provisions for Startup, Shutdown and Malfunction (SSM) Plans [40 CFR 63.6(e) and 63.8(c)] shall be used to satisf y the Pharmaceutical MACT standards [40 CFR 63.1259(a)(3)], Offsite Waste MACT [40 CFR 63.697(b)(3)], and PSD BACT requirements [326 IAC 2-1.1-11].

(a) Pursuant to 40 CFR 63.6(e)(3), the Permi ttee shall develop an SSM Plan to ensure that processes are operated and maintained in a manner which satisfies the general duty to minimize emissions established by 40 CFR 63.6(e)(1)(i), and that all malfunctions are corrected as soon as practicable after thei r occurrence in order to minimize excess emissions. The SSM Plan shall contain the following information:

(1) Detailed plans and/or procedures for operating and maintaining the process during periods of SSM; and

(2) Corrective action program for malfunctioning processes.

(b) The startup, shutdown and malfunction ( SSM) requirements for the RTO control system or T79 control system, via its associated clos ed vent system, are described in Sections D.14 and D.15 of this permit, respectively.

Testing and Monitoring Requirements [326 IAC 2-7-6(1) (6)] [326 IAC 2-7-5(1)]

D.10.5 Requirements

The requirements for the RTO control system and T79 fume incinerator control system, and associated closed-vent syst ems, used to control emissions from the emission units listed in this section are described in Sections D.14 and D.15 of this permit, respectively.

D.10.6 Monitoring Requirements

The monitoring requirements for the RTO control system and T79 fume incinerator control system

used to control emissions from the emission units listed in this section are described in Sections D.14 and D.15 of this permit, respectively.Eli Lilly and Company-Tippecanoe Labs 4 th Significant Permit Modifica tion No. 157-22717-00006 Page 93 of 226 Lafayette, Indiana Modified by: Aida De Guzman OP No. T157-6879-00006 Permit Reviewer: Dr. Trip Sinha

Record Keeping and Reporting Requirements [326 IAC 2-7-10.5, 326 IAC 2-7-12, 326 IAC 2-2, 40 CFR 60.7, 40 CFR 60 Subpart Kb, 40 CFR 63 Subpart DD, and 40 CFR 63 Subpart GGG]

D.10.7 Record Keeping and Reporting Requirements

(a) Record Keeping Requirements

(1) RTO Control System and T79 Control System Records - The record keeping requirements for the RTO control system and T79 fume incinerator control system used to control emissions from these emission units are described in Sections D.14 and D.15 of this permit, respectively.

(2) Inspection and Maintenance Records - The Permittee shall maintain the following

records:

(A) Identification and explanation of a ll BPM waste storage tanks unsafe to inspect, including a plan for when these tanks w ill be inspected;

(B) Identification and explanation of all BPM waste storage tanks difficult to inspect, including a plan for when these tanks w ill be inspected;

(C) Visual inspection log of BPM wast e storage tanks, including the date of inspection and a statement that no leaks were detected, if applicable;

(D) One-time Method 21 inspection log of each BPM waste storage tank, including the date of inspection an d a statement that no leaks were detected, if applicable;

(E) Information on each BPM waste storage tank inspection during which a leak is detected, including:

(i) Instrument identification number s, operator name or initials, and identification of the equipment;

(ii) Date the leak was detected and the date of the first attempt to repair the leak;

(iii) Maximum instrument reading measured after leak is successfully repaired or determined to be nonrepairable;

(iv) Reason for any delay of repair if leak not repaired within 15 calendar days after discovery of the leak;

(v) Name, initials, or other form of identification of person whose decision it was that repair could not be effected without a shutdown;

(vi) Expected date of successful r epair of leak if leak not required within 15 calendar days after discovery of leak;

(vii) Dates of shutdowns that occur while the equipment is unrepaired; and

(viii) Date of successful repair of the leak.

(F) Periods of planned routine maintenance; and

(G) Records of BPM waste storage tanks storing VOC/VOHAP with a vapor pressure less than 3.5 kPa.Eli Lilly and Company-Tippecanoe Labs 4 th Significant Permit Modifica tion No. 157-22717-00006 Page 94 of 226 Lafayette, Indiana Modified by: Aida De Guzman OP No. T157-6879-00006 Permit Reviewer: Dr. Trip Sinha

(3) SSM Records - The Permittee shall maintain the following records:

(A) Records of the current and superseded versions of SSM Plan.

(B) Occurrence/duration records of each process malfunction.

(C) Information to demonstrate conformance with each SSM are consistent wit the procedures in the SSM Plan.

(D) Records of actions taken during each SSM when different from SSM

Plan.

(4) LDAR Records - The record keeping requirements for the LDAR standards are described in Section E of this permit.

(5) Storage Tank Records - Pursuant to New Source Performance Standard for Volatile Organic Liquid Storage Vessels (40 CFR 60.116b(a) and (b)), the Permittee shall, for the life of the source , keep readily accessible records of the dimensions and capacity for all applicable BPM waste storage tanks.

(6) Operating Plan – Pursuant to 40 CFR 60. 115b, the Permittee shall, for the life of the source, maintain a copy of the operating plan required by 40 CFR 60.113b for all tanks with design capacity greater than or equal to 75 cubic meters.

(b) Quarterly Reporting Requirements

(1) The following streamlined quarterly reporting requirements shall satisfy the

Pharmaceutical MACT standards [40 CFR 63.1256(b)] and the PSD BACT requirements [326 IAC 2-1.1-11]:

(A) Inspections conducted during which a leak was detected;

(B) Periods of planned routine maintenance; and

(C) SSM summary reports for the processes.

(D) The reporting requirements for the RTO control system and T79 fume incinerator control system used to control emissions from these emission units are described in Sections D.14 and D.15 of this permit, respectively.

(E) The reporting requirements for t he LDAR standards are described in Section E of this permit.

(c) Immediate Reporting Requirements

The reporting requirements in the NESHAP G eneral Provisions for Startup, Shutdown and Malfunction (SSM) Plans [40 CFR 63.6(e)(3 )] shall be used to satisfy the reporting requirements under the Pharmaceutical MACT standards [40 CFR 63.1259(a)(3)], Offsite Waste MACT standards [40 CFR 63.697(b)(3 ), and PSD BACT requirements [326 IAC 2- 1.1-11].

(1) Any time an action taken by the Permi ttee during an SSM event of a process is not consistent with the procedures specified in the SSM Plan, the Permittee shall report the actions taken for that event. The immediate report shall be submitted to the agency via a telephone call or facsimile within 2 working days after commencing actions inconsistent with the plan.Eli Lilly and Company-Tippecanoe Labs 4 th Significant Permit Modifica tion No. 157-22717-00006 Page 95 of 226 Lafayette, Indiana Modified by: Aida De Guzman OP No. T157-6879-00006 Permit Reviewer: Dr. Trip Sinha

(2) Within 7 working days after the end of an SSM event of a process where an action taken by the Permittee is not consis tent with the procedures specified in the SSM Plan, the Permittee shall submit a letter containing the following information in accordance with 40 CFR 63.10(d)(5):

(A) Name, title and signature of respon sible official certifying accuracy;

(B) Explanation of the circ umstances for the event;

(C) Reason for not following the SSM Plan; and

(D) Report any excess emissions and/ or parameter monitoring exceedances

are believed to have occurred.

Modifications and Construction Requirements [326 IAC 2-7-10.5, 326 IAC 2-7-12 and 326 IAC 2-2]

D.10.8 Modifications and Construction: Advance approval of permit conditions

(a) The Permittee may modify any existing emissi on units listed in this section of the permit without obtaining a source modification appr oval (otherwise required by 326 IAC 2-7- 10.5), a Title V permit modification (otherwise required by 326 IAC 2-7-12), or a Prevention of Significant Deterioration permit (otherwise required by 326 IAC 2-2), provided the modified emission units are s ubject to the same applicable requirements listed in this D section, and the Permittee shall comply with the Change Management and Flexible Permit provisions in Section F.1 of this permit.

(b) The Permittee may construct and install new em ission units of the types described in this D section without obtaining a source modifica tion approval (otherwise required by 326 IAC 2-7-10.5), a Title V permit modification (otherwise required by 326 IAC 2-7-12), or a Prevention of Significant Deterioration permit (otherwise required by 326 IAC 2-2), provided the new emission units are subject to the same applicable requirements listed in this D section, and the Permittee shall comply with the Change Management and Flexible Permit provisions in Section F.1 of this permit.Eli Lilly and Company-Tippecanoe Labs 4 th Significant Permit Modifica tion No. 157-22717-00006 Page 96 of 226 Lafayette, Indiana Modified by: Aida De Guzman OP No. T157-6879-00006 Permit Reviewer: Dr. Trip Sinha

SECTION D.11 BPM SUPPORT OPERATIONS – WASTE CONTAINER CONDITIONS

Facility Description [326 IAC 2-7-5(15)]

The information describing the pr ocesses contained in the following facility description boxes is descriptive information and does not constitute enforceable conditions:

Emission

Unit ID Emission Unit Description Stack/Vent Nominal Capacity Control

Device

SMALL BPM WASTE CONTAINERS*:

A small BPM waste container, such as a drum, is defined as containing VOC/VOHAP and having a capacity greater than 0.1 cubic meters (26.4 gallo ns) and equal to or less than 0.42 cubic meters (110.5 gallons). Identification of these types of containers have not been indivi dually listed given they are portable and continually change. Each onsite wastewater container and offsite waste container with this description type will follow the compliance requirements outlined in this section.

LARGE BPM WASTE CONTAINERS*:

A large BPM waste container, such as tanker or melon, is defined as containing VOC/VOHAP and having a capacity greater than 0.42 cubic meters (110 .5 gallons). Identification of these types of containers have not been individually listed given th ey are portable and continually change. Each container with this description type will follow the compliance requirements outlined in this section.

* Emission units marked with an asterisk are insignifican t activities as defined by 326 IAC 2-7-1(21)(A)-(C).

Emission Limitations and Sta ndards [326 IAC 2-7-5(1)]

D.11.1 Standards for Small BPM Waste Containers [ 40 CFR 63.1256(d), 40 CFR 63.688, 326 IAC 2-2-3]

The following streamlined standards for small BPM waste containers satisfy the requirements of
the Pharmaceutical MACT Standards for wast ewater containers [40 CFR 63.1256(d)], OSWRO MACT Standards for waste containers [40 CF R 63.688], and PSD BACT requirements [326 IAC 2-2-3]:

(a) Definition Standards:

(1) A small BPM waste container is defined as any portable unit containing

VOC/VOHAP material at concentration s greater than 500 ppmw with a storage capacity of greater than 0.1 cubic meters (26.4 gallons) and less than or equal to 0.42 cubic meters (110.5 gallons).

(b) Operational Standards:

(1) The cover and all openings on each BPM waste container shall be maintained in the closed position, except when adding material, removing material, accessing

material for non-transfer-related routin e activities, openings caused from a pressure relief device, or opening of a safety device.

(2) Each BPM waste container containing VOC/VOHAP shall meet existing Department of Transportation (DOT) spec ifications and testing requirements
under 49 CFR 178.Eli Lilly and Company-Tippecanoe Labs 4 th Significant Permit Modifica tion No. 157-22717-00006 Page 97 of 226 Lafayette, Indiana Modified by: Aida De Guzman OP No. T157-6879-00006 Permit Reviewer: Dr. Trip Sinha

(c) Inspection Standards:

(1) Initial and semiannual visual inspections shall be conducted for improper work practices and control equipment failures.

(2) Inspections that are unsafe or difficult to inspect are not subject to the inspection requirements of D.11.1(c)(1).

(3) The Permittee shall attempt to repair any defect within 24 hours after detection of the defective container and complete the repair within 5 calendar days after detection. If repair of a defect cannot be completed within 5 calendar days, then

the waste shall be removed from the co ntainer and the container shall not be used to manage waste until the defect is repaired.

D.11.2 Standards for Large BPM Wast e Containers [40 CFR 63.1256(d), 40 CFR 63.688, 326 IAC 2-2-3, 326 IAC 2-7-24]

The following standards represent the streamli ned requirements of the Pharmaceutical MACT Standards under 40 CFR 63.1256(d), OSWRO MA CT Standards under 40 CFR 63.688, and Best Available Control Technology (BACT) requirements under 326 IAC 2-2-3:

(a) Definition Standards:

(1) A large BPM waste container is defined as any portable unit containing

VOC/VOHAP material at concentration s greater than 500 ppmw with a storage capacity of greater than 0.42 cu bic meters (110.5 gallons).

(b) Operational Standards:

(1) The cover and all openings on each large BPM waste container shall be maintained in the closed position, an d without leaks, except when adding material, removing material, accessing ma terial for non-transfer-related routine activities, opening from a pressure relief device, and opening of a safety device.

(2) A submerged fill pipe shall be used when pumping BPM liquid waste into a large BPM waste container. The submerged f ill pipe outlet shall extend to no more than 6 inches or within two fill pipe diamet ers of the bottom of the container while the container is being filled.

(c) Inspection Standards:

(1) One-time Method 21 inspections shall be conducted on each new large BPM waste container within 150 days upon first onsite usage.

(2) Initial and semiannual visual inspections shall be conducted for:

(A) Improper work practices;

(B) Control equipment failures; and

(C) Visible, audible, or olfactory indications of leaks.

(3) Inspections that are unsafe or difficult to inspect are not subject to the inspection requirements of D.11. 2(c)(1) and (2).

(4) The Permittee shall attempt to repair any defect within 24 hours after detection of the defective container and complete the repair within 5 calendar days after detection. If repair of a defect cannot be completed within 5 calendar days, thenEli Lilly and Company-Tippecanoe Labs 4 th Significant Permit Modifica tion No. 157-22717-00006 Page 98 of 226 Lafayette, Indiana Modified by: Aida De Guzman OP No. T157-6879-00006 Permit Reviewer: Dr. Trip Sinha

the waste shall be removed from the co ntainer and the container shall not be used to manage waste until the defect is repaired.

(d) The LDAR standards that apply to the co mponents associated with the emission units
listed in this section are described in Section E.2.

Record Keeping and Reporting Requirements [326 IAC 2-7-10.5, 326 IAC 2-7-12 and 326 IAC 2-2]

D.11.3 Record Keeping and Reporting Requirements

(a) Record Keeping Requirements

(1) The Permittee shall maintain the following records for inspections required by

Conditions D.11.1 and D.11.2:

(A) Identification and explanation of all containers unsafe to inspect, including a plan for when these containers will be inspected;

(B) Identification and explanation of all containers difficult to inspect, including a plan for when these containers will be inspected;

(C) Visual inspection log of BPM wa ste containers, including the date of inspection and a statement that no leaks were detected, if applicable;

(D) One-time Method 21 inspection log of each large BPM waste container, including the date of inspection an d a statement that no leaks were detected, if applicable;

(E) Information on each BPM waste container inspection during which a leak is detected, including:

(i) Instrument identification numbers (for Method 21 inspections only), operator name or initials, and identification of the equipment;

(ii) Date the leak was detected and the date of the first attempt to repair the leak; and

(iii) Date of successful repair of the leak or date material removed

from container.

(b) Quarterly Reporting Requirements

(1) The Permittee shall include the inspection records specified in D.11.3 (a)(5) for each inspection conducted during which a leak was detected in the next quarterly report.

Modifications and Construction Requirements [326 IAC 2-7-10.5, 326 IAC 2-7-12 and 326 IAC 2-2]

D.11.4 Modifications and Construction: Ad vance Approval of Permit Conditions

(a) The Permittee may modify any existing emissi on units listed in this section of the permit without obtaining a source modification appr oval (otherwise required by 326 IAC 2-7- 10.5), a Title V permit modification (otherwise required by 326 IAC 2-7-12), or a Prevention of Significant Deterioration permit (otherwise required by 326 IAC 2-2), provided the modified emission units are s ubject to the same applicable requirements listed in this D section, and the Permittee shall comply with the Change Management and Flexible Permit provisions in Section F.1 of this permit.Eli Lilly and Company-Tippecanoe Labs 4 th Significant Permit Modifica tion No. 157-22717-00006 Page 99 of 226 Lafayette, Indiana Modified by: Aida De Guzman OP No. T157-6879-00006 Permit Reviewer: Dr. Trip Sinha

(b) The Permittee may construct and install new em ission units of the types described in this D section without obtaining a source modifica tion approval (otherwise required by 326 IAC 2-7-10.5), a Title V permit modification (otherwise required by 326 IAC 2-7-12), or a Prevention of Significant Deterioration permit (otherwise required by 326 IAC 2-2), provided the new emission units are subject to the same applicable requirements listed in this D section, and the Permittee shall comply with the Change Management and Flexible Permit provisions in Section F.1 of this permit.

The remainder of the page is left blank intentionally.Eli Lilly and Company-Tippecanoe Labs 4 th Significant Permit Modificati on No. 157-22717-00006 Page 100 of 226 Lafayette, Indiana Modified by: Aida De Guzman OP No. T157-6879-00006 Permit Reviewer: Dr. Trip Sinha

SECTION D.12 T49 LIQUID WASTE INCINERATO R, INCLUDING ASSOCIATED AIR POLLUTION
CONTROL EQUIPMENT AND CONTINUOUS MONITORING SYSTEMS

Facility Description [326 IAC 2-7-5(15)]

The information describing the proces ses contained in the following fac ility description box is descriptive

information and does not constitute enforceable conditions:

Emission Unit Description Building Stack/Vent Nominal Capacity Control Device

T49 Liquid Waste Incinerator T49 T49 Stack 75 MMBtu/hr Condenser/Absorber; Hydro-SonicTM Scrubber

Emission Limitations and St andards [326 IAC 2-7-5(1)]

D.12.1 General Applicability Requirements with Em ission Standards [326 IAC 2-2-3 and 40 CFR 63, Subparts DD and EEE]

(a) Pursuant to the Hazardous Waste Combustor (HWC) MACT Standards [40 CFR 63.1206(b)(1)(i)] and the PSD BACT requirements [326 IAC 2-2-3], the emission standards and operating requirements shall a pply as specified in Conditions D.12.2, D.12.3, D.12.4, D.12.5, D.12.6, and D.12.7 except during peri ods of startup, shutdown,

and malfunction.

(b) Pursuant to the Off-Site Waste and Re covery Operations MACT Standards [40 CFR 63.684(b)(5)(i)], the T49 liquid waste incinerat or shall have a permit issued under 40 CFR 270 whenever off-site waste material is treated and destroyed in the T49 liquid waste incinerator. The incinerator shall operate in accordance with the HWC MACT standards under 40 CFR 63, Subpart EEE.

(c) Pursuant to the HWC MACT standards [ 40 CFR 63.1206(b)(5)(ii) and (iii)] and the PSD requirements [326 IAC 2-2-3], the Permittee may make a change in the design, operation, or maintenance practices document ed in the comprehensive performance test plan (CPT plan), Documentation of Compliance (DOC), Notification of Compliance (NOC), or startup, sh utdown, and malfunction plan (SSM plan), as long as the Permittee complies with the following requirements:

(1) If it is determined that the change ma y adversely affect compliance with any emission standard, the Permittee shall comp ly with the requirements specified in 40 CFR 63.1206(b)(5)(i) prior to implementing the change(s).

(2) If it is determined that the change will not adversely affect compliance with the emission standards of this condition, th e Permittee may implement the change(s) but must revise as necessary the per formance test plan, DOC, NOC, and SSM plan, to reflect the change(s).

D.12.2 Particulate Matter Emission Standar ds [40 CFR 63.1203 and 326 IAC 4-2]

In order to satisfy the HWC MACT standards [40 CFR 63.1203(a)(7)], the particulate matter (PM) emissions from the T49 liq uid waste incinerator st ack exhaust shall not exceed 34 milligrams per dry standard cubic meter (mg/dscm) (0.015 grai ns per dry standard cubic feet (gr/dscf)), corrected to 7 percent oxygen.Eli Lilly and Company-Tippecanoe Labs 4 th Significant Permit Modificati on No. 157-22717-00006 Page 101 of 226 Lafayette, Indiana Modified by: Aida De Guzman OP No. T157-6879-00006 Permit Reviewer: Dr. Trip Sinha

D.12.3 Sulfur Dioxide (SO 2 ) Emission Standards [326 IAC 2-2-3]

In order to satisfy the PSD BACT requirements [ 326 IAC 2-2-3], the T49 liquid waste incinerator shall be equipped with a caustic scrubber system to control SO 2 emissions. The SO 2 emissions

from the incinerator stack exhaust shall not exceed 500 ppmv dry corrected to 7% oxygen, averaged over a 24-hour da ily period when burning waste streams. This facility is not subject to
emission limitations and standards in 326 IAC 7 because the incinerator does not have the capability to burn fuel oil.

D.12.4 Oxides of Nitrogen (NOx) Emi ssion Standards [326 IAC 2-2-3]

In order to satisfy the PSD BACT requirements [ 326 IAC 2-2-3], the T49 liquid waste incinerator shall implement good combustion practices to control NO

x emissions. The NOx emissions from

the incinerator stack exhaust shall not exceed 975 ppmv dry corrected to 7% oxygen, expressed
as NO 2 , averaged over a 24-hour daily period when burning waste streams.

D.12.5 Hazardous Air Pollutant (HAP) and Fluori de Emission Standards [40 CFR 63.1203 and 326 IAC 2-2-3]

Except for periods of startup, shutdown and ma lfunction, the following emission standards shall apply at all times the T49 liquid waste incinerator is operating:

(a) Mercury – In order to satisfy the HWC MACT standards [40 CFR 63.1203(a)(2)], the mercury emissions from the T49 liquid waste incinerator stack exhaust shall not exceed 130 ug/dscm, corrected to 7% oxygen.

(b) Lead and Cadmium – In order to satisfy the HWC MACT standards [40 CFR 63.1203(a)(3)], the total semi-volatile metals (lead and cadmium) emissions from the T49 liquid waste incinerator stack exhaust sha ll not exceed 240 ug/dscm, corrected to 7%

oxygen.

(c) Arsenic, Beryllium, and Chromium – In or der to satisfy the HWC MACT standards [40 CFR 63.1203(a)(4)], the total low volatile metals (arsenic, beryllium, and chromium) emissions from the T49 liquid waste inciner ator stack exhaust shall not exceed 97 ug/dscm, corrected to 7 percent oxygen.

(d) Hydrochloric Acid/Chlorine Gas (HCl/Cl 2 ) and Fluorides – In order to satisfy the HWC MACT standards [40 CFR 63.1203(a)(6)], the HCl/Cl 2 emissions from the T49 liquid

waste incinerator stack exhaust shall not ex ceed 77 ppmv dry corrected to 7% oxygen, expressed as HCl equivalent. In order to satisfy the PSD BACT requirements for fluorides [326 IAC 2-2-3], the T49 liquid wast e incinerator control system shall achieve an HCl control efficiency of 98% or greater.

(e) Dioxin/Furans – In order to satisfy HW C MACT standards [40 CFR 63.1203(a)(1)], the dioxin/furan emissions from the T49 liquid waste incinerator stack exhaust shall not exceed 0.40 ng TEQ/dscm, corr ected to 7 percent oxygen.

(f) Principle Organic Hazardous Constituents (POHCs) – In order to satisfy the HWC MACT standards [40 CFR 63.1203(c)(1) and (2)], the Permittee shall comply with the following requirements:

(1) The destruction and removal efficiency (DRE) for each principle organic hazardous constituent (POHC), excluding dioxin-listed hazardous wastes F020, F021, F022, F023, F026, or F027 shall be at least 99.99 percent.

(2) Dioxin-listed hazardous wastes F020, F021, F022, F023, F026, or F027 shall not be burned in the T49 liquid waste incinerator.Eli Lilly and Company-Tippecanoe Labs 4 th Significant Permit Modificati on No. 157-22717-00006 Page 102 of 226 Lafayette, Indiana Modified by: Aida De Guzman OP No. T157-6879-00006 Permit Reviewer: Dr. Trip Sinha

(g) Operating Parameter Limits – In order to comply with the NESHAP from Hazardous Waste Combustors (HWC) emission limits in th is condition, the oper ating parameters of the T49 Incinerator, as established duri ng the performance tests done on August 10 through 12, 2004, shall not exceed limits described below as maximum limits or fail to

achieve limits described as minimum limits.

Operating Parameter Limit Units Averaging

Period Demonstrates Compliance for:

Minimum Atomizing Air

Media Pressure 60 psig 1-HR RA D.12.5(f)

Maximum Primary Waste Feed Viscosity 460 centipoise NA D.12.5(f)

Maximum Secondary Waste Feed Viscosity 460 centipoise NA D.12.5(f)

Maximum Primary

Waste Feed Rate 7,117 lbs/hr 1-HR RA D.12.5(e) D.12.5(f) Maximum Secondary

Waste Feed Rate 18,326 lbs/hr 1-HR RA D.12.5(e) D.12.5(f)

Minimum Combustion Temperature 1,850 o F 1-HR RA D.12.5(e) D.12.5(f)

Maximum Combustion

Air Flow Rate 15,022 acfm 1-HR RA D.12.5(a) D.12.5(b) D.12.5(c) D.12.5(d) D.12.5(e) D.12.5(f) Maximum Mercury

Feed Rate 0.0042 lbs/hr 12-hr RA D.12.5(a)

Maximum Semi-Volatile Metals (SVM) Feed

Rate 0.21 lbs/hr 12-hr RA D.12.5(b)

Maximum Low-Volatile Metals (LVM) Feed

Rate 0.30 lbs/hr 12-hr RA D.12.5(c)

Maximum Ash Feed

Rate 1,710 lbs/hr 12-hr RA D.12.2(a)

Maximum Total
Chlorine Feed Rate 3,690 lbs/hr 12-hr RA D.12.5(d)

Minimum
Condenser/Absorber

Flow Rate 600 gpm 1-HR RA D.12.5(a) D.12.5(b) D.12.5(c) D.12.5(d)

Minimum Differential

Pressure across
Condenser/Absorber 0.5 in.w.c 1-HR RA D.12.5(a) D.12.5(b) D.12.5(c) D.12.5(d)

Minimum Hydro-Sonic

Scrubber Flow Rate 290 gpm 1-HR RA D.12.2(a) D.12.5(a) D.12.5(b) D.12.5(c) D.12.5(d) Minimum Hydro-Sonic Equivalent Differential

Pressure 75 in.w.c 1-HR RA D.12.2(a) D.12.5(a) D.12.5(b)Eli Lilly and Company-Tippecanoe Labs 4 th Significant Permit Modificati on No. 157-22717-00006 Page 103 of 226 Lafayette, Indiana Modified by: Aida De Guzman OP No. T157-6879-00006 Permit Reviewer: Dr. Trip Sinha

Operating Parameter Limit Units Averaging

Period Demonstrates Compliance for:

D.12.5(c) D.12.5(d)

Minimum
Condenser/Absorber pH 4.9 S.U. 1-HR RA D.12.5(d)

Maximum
Condenser/Absorber %

Solids 3.5 %TDS 12-hr RA D.12.2(a) D.12.5(a) D.12.5(b) D.12.5(c)

D.12.6 Carbon Monoxide (CO) Emission Standards [326 IAC 2-2-3, 326 IAC 9-1, and 40 CFR 63.1203]

In order to satisfy the HWC MACT standa rds [40 CFR 63.1203(a)(5)(i)] and the PSD BACT requirements [326 IAC 2-2-3], the CO emissions from the T49 liquid waste incinerator stack exhaust shall not exceed 100 ppmv dry corrected to 7% oxygen, rolled on an hourly basis, at all times the incinerator is operating except during periods of startup, shutdown, and malfunction.

D.12.7 Hydrocarbon (HC) and Volatile Organic Compound (VOC) Emission Standards [326 IAC 2-2-3 and 40 CFR 63.1203]

During the POHC DRE test, the CO emissions shall not exceed an hourly rolling average of 100 ppmv dry corrected to 7% oxygen (monitored wi th continuous emissions monitoring system).

D.12.8 Automatic Waste Feed Cutoff Syst em Requirements [40 CFR 63.1206]

In order to satisfy the HWC MACT standards [40 CFR 63.1206], the Permittee shall operate the T49 liquid waste incinerator with a functioning Automatic Waste Feed Cutoff (AWFCO) system that meets the requirement s of 40 CFR 63.1206(c)(3).

(a) Except as allowed under (c) of this cond ition, the AWFCO system shall be operated such that it immediately and automatically cuts off the hazardous waste feed when any of the following occur at any time:

(1) An operating parameter is exceeded;

(2) An emission standard monitored by the CO CEMS is exceeded;

(3) A span value of any CMS, except a CEMS, is met or exceeded;

(4) Upon malfunction of a CMS (excluding the NOx and SO 2 CEMS) monitoring an operating parameter limit or emission level; or

(5) When any component of the automat ic waste feed cutoff system fails.

(b) During all AWFCO events, the Permittee shall continue to:Eli Lilly and Company-Tippecanoe Labs 4 th Significant Permit Modificati on No. 157-22717-00006 Page 104 of 226 Lafayette, Indiana Modified by: Aida De Guzman OP No. T157-6879-00006 Permit Reviewer: Dr. Trip Sinha

(1) Duct combustion gases to the air pollution control system while hazardous waste remains in the combustion chamber; and

(2) Monitor the applicable combustor operating parameters and emission levels.

(c) The Permittee may ramp down the hazardous waste feed rate of pumpable hazardous waste over a period not to exceed one (1) minute during an AWFCO event in accordance with the procedures in the O&M plan, provid ing the automatic waste feed cutoff is not triggered by an exceedance of any of the following operating limits:

(1) Minimum combustion chamber temperature,

(2) Maximum hazardous waste feed rate, or

(3) Any hazardous waste combustor firing system operating limits.

The procedures for AWFCO event s specified in the O& M plan must include a statement that the ramp down must begin immediately upon initiation of automatic waste feed cutoff and must prescribe a bona fide ramping down.

(d) After an AWFCO event, the Permittee shall not restart the hazardous waste feed until the operating parameters and emission levels are within their respective limits.

(e) If after any AWFCO event, there is an exc eedance of an emission standard or operating requirement, irrespective of whether the ex ceedance occurred while hazardous waste remained in the combustion chamber, the Permittee shall:

(1) Investigate the cause of the AWFCO,

(2) Take appropriate corrective measures to minimize future AWFCOs, and

(3) Record the findings and corrective measures in the operating record.

D.12.9 Leak Detection and Repair (LDAR) Program [ 326 IAC 2-2-3, 40 CFR 63, Subpart DD, 40 CFR 61, Subpart V]

The LDAR standards that apply to components as sociated with the waste transfer/feed systems connected to the T49 liquid waste incinerator ar e described in Section E.2 of this permit.

D.12.10 Inspection Requirem ents [40 CFR 63.1206(c)]

(a) In order to satisfy the HWC MACT standa rds [40 CFR 63.1206(c)(5)], the Permittee shall conduct daily visual inspections of the T49 liquid waste incinerator to ensure the

combustion zone is sealed.

(b) In order to satisfy the HWC MACT sta ndards [40 CFR 63.1206(c)(3)(vii)], the Permittee shall test the AWFCO system and associated al arms at least once per week to verify operability, unless the operating record docum ents that the weekly inspections unduly restrict or upset operations and that less frequent inspection will be adequate. At a minimum, the Permittee shall conduct operability testing monthly.

D.12.11 Training and Certification Requ irements [40 CFR 63.1206(c)(6)]

(a) In order to satisfy the HWC MACT standa rds [40 CFR 63.1206(c)(6)], the Permittee shall establish a Training and Certification Program for all categories of personnel whose activities may reasonably be expected to dire ctly affect emissions of HAPs from all operations associated with the T 49 liquid waste incinerator.Eli Lilly and Company-Tippecanoe Labs 4 th Significant Permit Modificati on No. 157-22717-00006 Page 105 of 226 Lafayette, Indiana Modified by: Aida De Guzman OP No. T157-6879-00006 Permit Reviewer: Dr. Trip Sinha

Said programs shall be of a technical level commensurate with the person’s duties as specified in the training manual. All operating training and certification programs shall be recorded in the operating record.

(b) A certified control room operator shall be on duty at the site at all times the T49 liquid waste incinerator is in operation and t he T49 liquid waste incinerator, including associated air pollution control equipment and continuous monitoring systems, shall be operated and maintained at all times by perso ns who are trained and certified according to the Training and Certification Program.

D.12.12 Plans and Procedures [326 IAC 2-2-3, 40 CFR 63.1206, 40 CFR 63.1211, 326 IAC 2-7-5(13)]

In order to satisfy the HWC MACT Standards [40 CFR 63.1206] and the PSD BACT requirements [326 IAC 2-2-3], the Permittee shall develop and implement the following written plans, which shall be maintained in the operating record:

(a) Operations and Maintenance (O&M) Plan – The O&M Plan shall define operations during periods of normal operation pursuant to 40 CFR 63.1206(c)(1) and (7).

(b) Startup, Shutdown, and Malfunction (S SM) Plan shall be developed and implemented in

accordance with 40 CFR 63. 1206(c)(2), 40 CFR 63.6(e)(3), and 40 CFR 63.8(c), to ensure that the T49 liquid waste incinerator , including associated air emission control equipment and CEMS and CMS, is operated and maintained in a manner which satisfies the general duty to minimize emissions est ablished by 40 CFR 63.6(e)(1)(i), and that all malfunctions are corrected as soon as practicable after their occurrence in order to minimize excess emissions. The SSM Plan shall contain the following information:

(1) Detailed procedures for operating and maintaining the T49 liquid waste incinerator system, including associated CEMS and CMS equipment, during periods of startup, shut down, and malfunction; and

(2) Corrective action program for malfun ctioning process, air pollution control, CEMS, and CMS equipment.

(c) Feedstream Analysis Plan -The Feedstr eam Analysis Plan shall be developed and implemented in accordance with 40 CFR 63. 1209(c)(2) for those parameters with feed

rate limits defined in Condition D.12.15.

(d) Continuous Emissions Monitoring System (CEMS) Standard Operating Procedures (SOP) – The Permittee shall prepare and im plement a SOP that provides step-by-step procedures and operations of the CEMS in accordance with 326 IAC 3-5-4(a)(9) – Preventive maintenance procedur es and corrective maintenance procedures that include those procedures taken to ensure continuous operation and to minimize malfunctions.

Testing and Monitoring Requirements [326 IAC 2-7-6(1) (6)] [326 IAC 2-7-5(1)]

D.12.13 Performance Test Requirements [40 CFR 63.1207, 326 IAC 2-1.1-11, 326 IAC 3-6]

The following streamlined performance test re quirements shall satisfy the NESHAP General Provisions [40 CFR 63.7], the HWC MACT requirements [40 CFR 63.1207 and 63.1209], the PSD BACT requirements for VOC and fluorides [326 IAC 2-1.1-11] and the State emission testing requirements [326 IAC 3-6]:

(a) Initial Comprehensive Performance Test Requirements:

(1) The Permittee shall submit a notificatio n of intention to conduct a comprehensive performance test and CMS performance evaluation and a site-specific test planEli Lilly and Company-Tippecanoe Labs 4 th Significant Permit Modificati on No. 157-22717-00006 Page 106 of 226 Lafayette, Indiana Modified by: Aida De Guzman OP No. T157-6879-00006 Permit Reviewer: Dr. Trip Sinha

and CMS performance evaluation test plan at least one year before the performance test and performance evaluation are scheduled to begin.

(2) The Permittee shall perform initial comprehensive performance tests within 6 months after the HWC MACT compliance date unless an exemption is granted pursuant to 40 CFR 63.1207(e)(3).

(3) The Permittee shall submit a notification of intention to conduct the comprehensive performance test at least 60 calendar days before the test is scheduled to begin.

(4) The initial comprehensive performance tests shall be conducted under operating conditions representative of the extreme range of normal conditions as specified in 40 CFR 63.6(f)(2)(iii)(B) and 63.7(e)(1 ) for the worst case mode associated with each applicable pollutant limit or emission standard.

(5) The operating parameters defined in C ondition D.12.15 shall be monitored during the performance test to establish the parametric limits.

(6) All required comprehensive performance testing shall be completed within 60 days after the date of commencement of the tests pursuant to 40 CFR 63.1207(d)(3).

(7) The Permittee may use previous emissions test data in lieu of the initial comprehensive performance tests as allowed under 40 CFR 63.1207(c)(2).

(8) Pursuant to 40 CFR 63.7(h)(2), indivi dual performance tests may be waived upon written application to the Administrator if, in the Administrator’s judgment, the source is meeting the relevant standard(s ) on a continuous basis, or the source is being operated under an extension of compliance, or the owner or operator has requested an extensio n of compliance and the Administrator is still considering the request.

(9) Pursuant to 40 CFR 63.1207(j), the Permittee shall:

(A) Postmark a Notification of Compliance (NOC) documenting compliance or noncompliance with the emission standards and continuous monitoring system requirements and identify operating parameter limits under 40 CFR 63.1209 within 90 days of completion of the comprehensive performance test; and

(B) Comply with all operating requireme nts specified in the NOC in lieu of the limits specified in the Documentation of Compliance required under 40 CFR 63.1211(c) upon postmark of the NOC.

These submittal requirements satisfy t he reporting requirements of 326 IAC 3-6 as allowed under extension provisions of 326 IAC 3-6-4(b).

(b) Subsequent Comprehensive Performance Tests

(1) Pursuant to 40 CFR 63.1207(d)(4)(i), no subsequent comprehensive performance tests (includi ng DRE tests) shall be required until the U.S. EPA promulgates permanent replacement standards pursuant to the Settlement Agreement noticed in the Federal Regi ster on November 16, 2001, unless the Permittee modifies or otherwise alters op erations such that compliance with the
emission standards of Conditions D.12.2, D.12.5, and D.12.7 cannot be

achieved.Eli Lilly and Company-Tippecanoe Labs 4 th Significant Permit Modificati on No. 157-22717-00006 Page 107 of 226 Lafayette, Indiana Modified by: Aida De Guzman OP No. T157-6879-00006 Permit Reviewer: Dr. Trip Sinha

(2) Upon promulgation of the permanent re placement standards, the Permittee shall comply with the subsequent comprehens ive testing requirements established.

(c) Confirmatory Performance Tests

(1) Pursuant to 40 CFR 63.1207(d)(4)(ii), no confirmatory performance tests shall be required until the U.S. EPA promulgat es permanent replacement standards pursuant to the Settlement Agreement noticed in the Federal Register on November 16, 2001.

(2) Upon promulgation of the permanent re placement standards, the Permittee shall comply with the subsequent comprehens ive testing requirements established.

D.12.14 Continuous Emissions Moni toring Systems (CEMS) Operat ing Requirements [40 CFR 63.1209, 40 CFR 63.8, 326 IAC 2-7-24, 326 IAC 3-5, 326 IAC 2-1.1-11, 40 CFR 60, Appendix B, and 40 CFR 60, Appendix F]

(a) CO and O 2 CEMS Operation Requirements – The following provisions shall be applied at all times the T49 incinerator is in operati on and represent the streamlined requirements of the HWC MACT standards for CO and HC [40 CF R 63.1209(a), (d), (e), (f), and (h)], PSD BACT requirements for CO and VOC [326 IAC 2-1.1-11], and the emission monitoring requirements for MACT and PSD sources [326 IAC 3-5-1(b) and (d)]:

(1) The Permittee shall install and operate the CO and O 2 CEMS in accordance with the QA requirements of the HWC MACT standards [40 CFR 63, Appendix to Subpart EEE], the applicable QC and performanc e evaluation requi rements of 40 CFR 63.1209(d), and the applicable perf ormance specification requirements of 40 CFR 60, Appendix B.

(2) The CEMS shall be installed and operati onal upon certification of the DOC for the

HWC MACT.

(3) Continuous operation is defined as the collection of at least one measurement for each successive 15-minute period.

(b) SO 2 and NOx CEMS Operation Requirements – The following requirements shall apply when the T49 Incinerator is burning waste

(1) The Permittee shall install and operate the SO 2 and NOx CEMS in accordance with the QA/QC criteria set forth in 40 CFR 60, Appendix B and 40 CFR 60, Appendix F, Procedure 1.

(2) Continuous operation is defined as the collection of at least one measurement for each successive 15-minute period.

(3) The Startup, Shutdown, and Malf unction (SSM) Plan required by Condition D.12.12 (b) shall include procedures for monitoring and recording the following information during times of SO 2 or NOx CEMS malfunction:

(A) When the SO 2 CEMS malfunctions, the Permittee shall monitor and record the Hydro-SonicTM equivalent pressure drop and scrubber liquid flow rate as required by Conditi on D.12.15 (a)(3)(C) and (D) and the scrubber liquid pH as required by Condition D.12.15 (a)(5)(C).

(B) When the NOx CEMS malfunctions, the Permittee shall monitor and record the combustion chamber temperature, combustion air flow rate, and primary and secondary waste feed rates as required by Condition D.12.15 (a)(1), and assess NOx emissions, using waste testing, waste shipment and process knowledge, to determine whether the quantity ofEli Lilly and Company-Tippecanoe Labs 4 th Significant Permit Modificati on No. 157-22717-00006 Page 108 of 226 Lafayette, Indiana Modified by: Aida De Guzman OP No. T157-6879-00006 Permit Reviewer: Dr. Trip Sinha

nitrogen fed into the incinerator duri ng that time could have exceeded the worst case 24-hour daily average nitrogen feed rate of 1,650 pounds per
hour that formed the basis of the NOx BACT limit.

D.12.15 Parametric Continuous Monitoring System s (CMS) Requirements [40 CFR 63.8(c), 40 CFR 63.1209, and 326 IAC 2-1.1-11]

(a) The Permittee shall operate the CMS to monitor the Operating Parameter Limits (OPLs) listed in D.12.5(g) in accordance with the quality assurance requirements specified in 40 CFR 63.1209(d) at all times the T49 incinerat or is in operation. To satisfy the HWC MACT standards [40 CFR 63.1209(b), (d), (e), (f), and (h)] and the requirements for PSD sources [326 IAC 2-1.1-11] the parameters li sted in D.12.5(g) shall be monitored at all times the T49 incinerator is in operation.

(b) Continuous operation is defined as the co llection of at least one measurement for each successive 15-second period.

(c) Pursuant to the HWC MACT standards [40 CFR 63.1209(a)(5)] and the compliance monitoring methods for PSD sources [326 IAC 2-1.1-11], the Permittee may petition the Administrator to use CEMS for compliance monitoring in lieu of compliance with the operating parameter limits established in (a) of this condition.

(d) If applicable, the Permittee may document co mpliance using the waiver provisions of 40 CFR 63.1207(m) in lieu of complying with the requirements of (a) and (c) of this condition.

D.12.16 Minimum Data Requirements – SO 2 and NOx Compliance [326 IAC 2-1.1-11]

The following defines when CEMS data must be supplemented with data required by condition D.12.14 (b)(3), D.12.17 (a)(12), and D.12.18 (a)(2):

(a) When the period of incinerator operation (i.e., receiving waste streams) is 4 hours or greater in an operating day and monitoring data are insufficient to constitute a valid hour of data for at least 75 % of the operating hours, or

(b) When the period of incinerator operation (i.e., receiving waste streams) is less than 4 hours in an operating day and more than one of the hours during the period of operation does not constitute a valid hour of data due to insufficient monitoring data.

(c) Monitoring data are insufficient to constitute a valid hour of data if measured values are unavailable for any of the required 15-minute periods within the hour.

Record Keeping and Reporting Requiremen t [326 IAC 2-7-5(3)] [326 IAC 2-7-19]

D.12.17 Record keeping Requirements

(a) The Permittee shall maintain the following records:

(1) Notifications, reports, and other do cuments, such as the Documentation of Compliance, as required by 40 CFR 63.1200, 63.1211(c), and 63.10(b) and (c).

(2) All data recorded by continuous monito ring systems (CMS), including continuous emission monitoring systems (CEMS), required by Conditions D.12.14 and D.12.15;

(3) Documentation that a change will not adversely affect compliance with the emission standards or operating requirements as required by 40 CFR 63.1206(b)(5)(ii);Eli Lilly and Company-Tippecanoe Labs 4 th Significant Permit Modificati on No. 157-22717-00006 Page 109 of 226 Lafayette, Indiana Modified by: Aida De Guzman OP No. T157-6879-00006 Permit Reviewer: Dr. Trip Sinha

(4) Records of the estimated hazardous waste residence time as required by 40 CFR 63.1206(b)(11);

(5) Plans and procedures as required by Condition D.12.12;

(6) Documentation of the results of the inve stigation, corrective measures taken, and

evaluation of excessive exceedances duri ng malfunctions as required by 40 CFR 63.1206(c)(2)(v)(A);

(7) Corrective Measures for any AWFCO that results in an exceedance of an applicable emission standard or operating parameter limit as required by 40 CFR 63.1206(c)(3)(v);

(8) Documentation of the results of the AWFCO operability testing as required by Condition D.12.10 (b) and 40 CFR 63.1206(c)(3)(vii);

(9) Daily visual inspection records of the T49 liquid waste incinerator to ensure the combustion zone is sealed as required by Condition D.12.10 (a) and 40 CFR 63.1206(c)(5);

(10) A copy of the Operator Certificati on and Training Program required by Condition D.12.11 and 4 0 CFR 63.1206(c)(6);

(11) Documentation of the changes in m odes of operation as required by 40 CFR 63.1209(q); and

(12) For days when Condition D.12.16 requires that CEMS data must be supplemented, the documentation of t he information required by Condition D.12.14 (b)(3).

D.12.18 Reporting Requirements

(a) Quarterly Reporting Requirements

(1) The following streamlined quarterly repo rting requirements shall satisfy the HWC MACT standards [40 CFR 63.1211], wh ich references the MACT General Provisions [63.7-63.10], PSD BACT requirements [326 IAC 2-1.1-11], and the continuous emissions monitoring requirements [326 IAC 3-5]:

(A) Reports shall be submitted within 30 days following the reporting period using the reporting forms located at the end of this permit, or their equivalent;

(B) Summary reports of excess emis sions, parameter exceedances, and monitor downtime including informati on specified in 63.10(c)(5)-(c)(13);

(C) SSM summary reports for the T49 waste incinerator control system, including associated CEMS and CMS equipment;

(D) Excessive exceedances report, if applicable, as required by 40 CFR 63.1206(c)(3)(vi); and

(2) In addition to the requirements described in (a)(1) of this condition, the Permittee shall report the following information for the NOx and SO 2 CEMS to satisfy the PSD BACT requirements [326 IAC 2-1.1-11]:

(A) A list of days when condition D.12. 16 requires that CEMS data must be supplemented that provides:Eli Lilly and Company-Tippecanoe Labs 4 th Significant Permit Modificati on No. 157-22717-00006 Page 110 of 226 Lafayette, Indiana Modified by: Aida De Guzman OP No. T157-6879-00006 Permit Reviewer: Dr. Trip Sinha

(B) A detailed report for each day when condition D.12.16 requires that CEMS data must be supplemented:

(i) the information required by Condition D.12.14 (b)(3), and

(ii) an analysis of whether that information indicates continuous compliance with the limit established in Condition D.12.3 or D.12.4, and if the NOx CEMS malfunctions for greater than six continuous hours, an assessment of NOx emissions using waste testing, waste shipment, and process knowledge whether the quantity of nitrogen fed into the incinerator during that time could have exceeded the worst case 24-hour daily average nitrogen feed rate of 1,650 pounds per hour that formed the basis of the
NOx BACT limit.

(b) Immediate Reporting Requirements

(1) The Permittee shall submit any revision to the SSM Plan that may significantly increase emissions of hazardous air pollu tants to the Administrator for approval within 5 days after making a change to the plan to satisfy the reporting requirements under the HWC MACT standa rds [40 CFR 63.1206(c)(2)(ii)(C)].

(2) The reporting requirements in the N ESHAP General Provisions for Startup, Shutdown and Malfunction (SSM) Plans [ 40 CFR 63.6(e)(3)] shall be used to satisfy the reporting requirements unde r the HWC MACT standards [40 CFR 63.1206(c)(2)] and PSD BACT require ments [326 IAC 2-1.1-11].

(A) The Permittee shall report all ac tions taken during a T49 incinerator system SSM event that results in an exceedance of a relevant emission standard when those actions are inconsistent with the procedures specified in the SSM Plan. The immediate report shall be submitted to the agency via a telephone call or facsimile within 2 working days after commencing actions inconsistent with the plan.

(B) Within 7 working days after the end of an SSM event where an action taken by the Permittee is not consistent with the procedures specified in the SSM Plan, the Permittee shall submit a letter containing the following information in accordance with 40 CFR 63.10(d)(5):

(i) Name, title and signature of responsible official certifying

accuracy;

(ii) Explanation of the ci rcumstances of the event;

(iii) Reason for not following the SSM Plan; and

(iv) Report any excess emissions and/or parameter monitoring

exceedances are believed to have occurred.

Modifications and Construction Requirements [326 IAC 2-7-10.5, 326 IAC 2-7-12 and 326 IAC 2-2]

D.12.19 Modifications and Construction: Ad vance Approval of Permit Conditions

(a) The Permittee may modify any existing emissi on units listed in this section of the permit without obtaining a source modification appr oval (otherwise required by 326 IAC 2-7- 10.5), a Title V permit modification (otherwise required by 326 IAC 2-7-12), or a Prevention of Significant Deterioration permit (otherwise required by 326 IAC 2-2), provided the modified emission units are s ubject to the same applicable requirementsEli Lilly and Company-Tippecanoe Labs 4 th Significant Permit Modificati on No. 157-22717-00006 Page 111 of 226 Lafayette, Indiana Modified by: Aida De Guzman OP No. T157-6879-00006 Permit Reviewer: Dr. Trip Sinha

listed in this D section, and the Permittee shall comply with the Change Management and Flexible Permit provisions in Section F.1 of this permit.

(b) The Permittee may construct and install new em ission units of the types described in this D section without obtaining a source modifica tion approval (otherwise required by 326 IAC 2-7-10.5), a Title V permit modification (otherwise required by 326 IAC 2-7-12), or a Prevention of Significant Deterioration permit (otherwise required by 326 IAC 2-2), provided the new emission units are subject to the same applicable requirements listed in this D section, and the Permittee shall comply with the Change Management and Flexible Permit provisions in Section F.1 of this permit.

The remainder of the page is left blank intentionally.Eli Lilly and Company-Tippecanoe Labs 4 th Significant Permit Modificati on No. 157-22717-00006 Page 112 of 226 Lafayette, Indiana Modified by: Aida De Guzman OP No. T157-6879-00006 Permit Reviewer: Dr. Trip Sinha

SECTION D.13 T149 ROTARY KILN INCINERATO R, INCLUDING ASSOCIATED AIR POLLUTION
CONTROL EQUIPMENT AND CONTINUOUS MONITORING SYSTEMS

Facility Description [326 IAC 2-7-5(15)]

The information describing the proces ses contained in the following fac ility description box is descriptive

information and does not constitute enforceable conditions:

Emission Unit Description Building Stack/Vent Nominal Capacity Control Device

T149 Rotary Kiln incinerator with Secondary Combustion Chamber

(Natural Gas for Startup, Fuel Oil for Deslagging Operations) T149 T149 Stack 50 MMBtu/hr SNCR; Condenser/Absorber; Hydro-SonicTM Scrubber

Emission Limitations and St andards [326 IAC 2-7-5(1)]

D.13.1 General Applicability Requirements with Em ission Standards [326 IAC 2-2-3 and 40 CFR 63, Subparts DD and EEE]

(a) Pursuant to the Hazardous Waste Combustor (HWC) MACT Standards [40 CFR 63.1206(b)(1)(i)] and the PSD BACT requirements [326 IAC 2-2-3], the emission standards and operating requirements shall a pply as specified in Conditions D.13.2, D.13.3, D.13.4, D.13.5, D.13.6, and D.13.7 except during peri ods of startup, shutdown,

and malfunction.

(b) Pursuant to the Off-Site Waste and Re covery Operations MACT Standards [40 CFR 63.684(b)(5)(i)], the T149 rotary kiln inciner ator shall have a permit issued under 40 CFR 270 whenever off-site waste material is treated and destroyed in the T149 rotary kiln incinerator. The incinerator shall operate in accordance with the HWC MACT standards under 40 CFR 63, Subpart EEE.

(c) Pursuant to the HWC MACT standards [ 40 CFR 63.1206(b)(5)(ii) and (iii)] and the PSD BACT requirements [326 IAC 2-2-3], the Permittee may make a change in the design, operation, or maintenance practices document ed in the comprehensive performance test plan (CPT plan), Documentation of Compliance (DOC), Notification of Compliance (NOC), or startup, sh utdown, and malfunction plan (SSM plan), as long as the Permittee complies with the following requirements:

(1) If it is determined that the change ma y adversely affect compliance with any emission standard, the Permittee shall comp ly with the requirements specified in 40 CFR 63.1206(b)(5)(i) prior to implementing the change(s).

(2) If it is determined that the change will not adversely affect compliance with the emission standards of this condition, th e Permittee may implement the change(s) but must revise as necessary the per formance test plan, Documentation of Compliance, Notification of Compliance, and startup, shutdown, and malfunction plan, to reflect the change(s).

D.13.2 Particulate Matter Emissi on Standards [40 CFR 63.1203]

In order to satisfy the HWC MACT standards [40 CFR 63.1203(b)(7)], the particulate matter (PM) emissions from the T149 rotary kiln incinerator stack exhaust shall not exceed 34 mg/dscm (0.015 gr/dscf), corrected to 7 percent oxygen.Eli Lilly and Company-Tippecanoe Labs 4 th Significant Permit Modificati on No. 157-22717-00006 Page 113 of 226 Lafayette, Indiana Modified by: Aida De Guzman OP No. T157-6879-00006 Permit Reviewer: Dr. Trip Sinha

D.13.3 Sulfur Dioxide (SO 2 ) Emission Standards [326 IAC 2-2-3 and 326 IAC 7-1.1-2]

(a) In order to satisfy the PSD BACT requirements [326 IAC 2-2-3], the T149 rotary kiln incinerator shall be equipped with a caustic scrubber system to control SO 2 emissions.
The SO 2 emissions from the incinerator stac k exhaust shall not exceed 400 ppmv dry corrected to 7% oxygen, averaged over a 24-hour daily period when burning waste

streams.

(b) In order to satisfy the State SO 2 rules [326 IAC 7-1.1-2], the SO 2 emissions from the combustion of fuel oil during the deslagging process in the T149 rotary kiln incinerator shall not exceed 0.5 pounds per million Br itish thermal units (lbs/MMBtu).

D.13.4 Oxides of Nitrogen (NOx) Emi ssion Standards [326 IAC 2-2-3]

In order to satisfy the PSD BACT requirements [ 326 IAC 2-2-3], the T149 rotary kiln incinerator shall be equipped with selective non-catalytic reduction (SNCR) equipment to control NO

x emissions. The NOx emissions from the incine rator stack exhaust shall not exceed 170 ppmv dry corrected to 7% oxygen, expressed as NO 2 , averaged over a 24-hour daily period when burning

waste streams.

D.13.5 Hazardous Air Pollutant (HAP) Emission Standards [4 0 CFR 63.1203, US EPA approved Alternative Monitoring Petition initially approved January 27, 2006]

Except for periods of startup, shutdown and malf unctions, the following emission standards shall apply at all times the T149 rotary kiln incinerator is operating:

(a) Mercury – Pursuant to the HWC MACT st andards [40 CFR 63.1203(b)(2)], the mercury emissions from the T149 rotary kiln inciner ator stack exhaust shall not exceed 45 ug/dscm, corrected to 7% oxygen on a 12-hour rolling average basis, from block hourly

averages.

(b) Lead and Cadmium – Pursuant to the HWC MACT standards [40 CFR 63.1203(b)(3)], the total semi-volatile metals (lead and cadmium) emissions from the T149 rotary kiln

incinerator stack exhaust shall not exceed 120 ug/dscm, corrected to 7 percent oxygen on a 12-hour rolling average basis, from block hourly averages.

(c) Arsenic, Beryllium, and Chromium – Purs uant to the HWC MACT standards [40 CFR 63.1203(b)(4)], the total low volatile metals (arsenic, beryllium, an d chromium) emissions from the T149 rotary kiln incinerator stack exhaust shall not exceed 97 ug/dscm, corrected to 7 percent oxygen on a 12-hour rolling average basis, from block hourly

averages.

(d) Hydrochloric Acid/Chlorine Gas (HCl/Cl 2 ) and Fluorides - In order to satisfy the HWC MACT standards [40 CFR 63.1203(b)(6)], the HCl/Cl 2 emissions from the T149 rotary kiln

incinerator stack exhaust shall not exceed 21 ppmvdc, expressed as HCl equivalent on a 12-hour rolling average basis, from block hourly averages. In order to satisfy the PSD BACT requirements for fluorides [326 IAC 2-2-3], the T149 rotary kiln incinerator control system shall achieve an HCl control e fficiency of 98 percent or greater.

(e) Dioxin/Furans – Pursuant to HWC MA CT standards [40 CFR 63.1203(b)(1)], the dioxin/furan emissions from the T149 rotary kiln incinerator stack exhaust shall not exceed 0.20 ng TEQ/dscm, corr ected to 7 percent oxygen.

(f) Principle Organic Hazardous Constituents (POHCs) – Pursuant to the HWC MACT standards [40 CFR 63.1203(c)(1) and (2)], the Permittee shall comply with the following requirements:Eli Lilly and Company-Tippecanoe Labs 4 th Significant Permit Modificati on No. 157-22717-00006 Page 114 of 226 Lafayette, Indiana Modified by: Aida De Guzman OP No. T157-6879-00006 Permit Reviewer: Dr. Trip Sinha

(1) The destruction and removal efficiency (DRE) for each principle organic hazardous constituent (POHC), excluding dioxin-listed hazardous wastes F020, F021, F022, F023, F026, or F027 shall be at least 99.99 percent.

(2) Dioxin-listed hazardous wastes F020, F021, F022, F023, F026, or F027 shall not be burned in the T149 rotary kiln incinerator.

(g) Operating Parameter Limits – In order to comply with the NESHAP from Hazardous Waste Combustors (HWC) emission limits in th is condition, the oper ating parameters of the T149 Rotary Kiln Incinerator, as es tablished during the performance tests done on September 20 and 21, 2005, and associated emission control equipment shall not

exceed limits described below as maximum lim its or fail to achieve limits described as

minimum limits.

The limits below are applicable when moni toring is required by D.13.15(a).

Operating Parameter Limit Averaging

Period Operating

Limit Units

Maximum Primary Waste Feed to Primary Combustion

Chamber 1-hr RA 1 1,501 lbs/hr

Maximum Secondary Waste Feed to Primary

Combustion Chamber 1-hr RA 1 4,655 lbs/hr

Maximum Solid Feed Rate 1-hr RA 1 5,529 lbs/hr

Minimum Primary Combustion Chamber Temperature 1-hr RA 1 1,598 o F
Maximum Primary Waste Feed to Secondary

Combustion Chamber 1-hr RA 1 1,801 lbs/hr

Maximum Secondary Waste Feed to Secondary

Combustion Chamber 1-hr RA 1 1,440 lbs/hr

Minimum Secondary Combustion Chamber Temperature 1-hr RA 1 1,809 o F

Maximum Stack Gas Flow Rate 1-hr RA 1 18,812 dscfm

Maximum Waste Feed Viscosity Monthly Analysis 460 Centi-poise

Minimum Waste Atomizing Pressure 1-hr RA 1 75 psig

Maximum Mercury Feed Rate in all Feed Streams 12-hr RA 0.0038 lbs/hr

Maximum SVM Feed Rate in all Feed Streams 12-hr RA 3.2 lbs/hr

Maximum LVM Feed Rate in all Feed Streams 12-hr RA 490 lbs/hr
Maximum LVM feed rate in all Pumpable Feed Streams 12-hr RA 5.0 lbs/hr

Maximum ash feed rate in all feed streams 12-hr RA 4,168 lbs/hr

Maximum Total Chlorine feed rate in all feed streams 12-hr RA 1,977 lbs/hr
Minimum Condenser/Absorber pressure drop 1-hr RA 1 in w.c.
Minimum Condenser/Absorber liquid feed pressure 1-hr RA 5 psig
Minimum Condenser/Absorber scrubber water pH 1-hr RA 2.5 pH
Minimum Condenser/Absorber scrubber liquid flow rate 1-hr RA 980 gpm Minimum Hydro-Sonic Scrubber Equivalent Pressure Drop 1-hr RA 53 in w.c.

Maximum Hydro-Sonic Scrubber conductivity 12-hr RA 2.3 % solids
Minimum Hydro-Sonic Scrubber Liquid Feed Rate 1-hr RA 286 gpm
Minimum Hydro-Sonic Scrubber water pH 1-hr RA 2.5 pH

1. CMS shall be operated as described in D.13.15.Eli Lilly and Company-Tippecanoe Labs 4 th Significant Permit Modificati on No. 157-22717-00006 Page 115 of 226 Lafayette, Indiana Modified by: Aida De Guzman OP No. T157-6879-00006 Permit Reviewer: Dr. Trip Sinha

D.13.6 Carbon Monoxide (CO) Emission Standards [326 IAC 2-2-3, 326 IAC 9-1, and 40 CFR 63.1203]

In order to satisfy the HWC MACT standa rds [40 CFR 63.1203(b)(5)(i)] and the PSD BACT requirements [326 IAC 2-2-3], the CO emissions from the T149 rotary kiln incinerator stack exhaust, as monitored by a continuous emission s monitoring system (CEMS), shall not exceed 100 ppmv dry corrected to 7% oxygen, averaged ov er an hourly rolling basis, at all times the incinerator is operating except durin g startup, shutdown and malfunctions.

D.13.7 Hydrocarbon (HC) and Volatile Organic Compound (VOC) Emission Standards [326 IAC 2-2-3 and 40 CFR 63.1203]

(a) In order to satisfy the HWC MACT st andards [40 CFR 63.1203(b)(5)(i)] and the PSD BACT requirements [326 IAC 2-2-3], the highest hourly rolling average hydrocarbon emissions achieved, as monitored with a CE MS during an acceptable DRE test, shall not exceed 10 ppmv dry corrected to 7% oxygen or 99.99 percent, reported as propane.

(b) During the DRE test for hydrocarbons, the CO emissions shall not exceed an hourly rolling average of 100 ppmv dry corrected to 7% oxygen (monitored with continuous emissions monitoring system).

D.13.8 Automatic Waste Feed Cutoff Syst em Requirements [40 CFR 63.1206]

In order to satisfy the HWC MACT standards, t he Permittee shall operate the T149 rotary kiln

incinerator with a functioning Automatic Waste Feed Cu toff (AWFCO) system that meets the requirements of 40 CFR 63.1206(c)(3).

(a) Except as allowed under (c) of this cond ition, the AWFCO system shall be operated such that it immediately and automatically cuts off the hazardous waste feed when any of the following occur at any time:

(1) An operating parameter is exceeded;

(2) An emission standard monitored by the CO CEMS is exceeded;

(3) A span value of any CMS, except a CEMS, is met or exceeded;

(4) Upon malfunction of a CMS (excluding the NOx and SO 2 CEMS) monitoring an operating parameter limit or emission level; or

(5) When any component of the automat ic waste feed cutoff system fails.

(b) During all AWFCO events, the Permittee shall continue to:

(1) Duct combustion gases to the air pollution control system while hazardous waste remains in the combustion chamber; and

(2) Monitor the applicable combustor operating parameters and emission levels.

(c) The Permittee may ramp down the haza rdous waste feedrate of pumpable hazardous waste over a period not to exceed one (1) minute during an AWFCO event in accordance with the procedures in the O&M plan, provid ing the automatic waste feed cutoff is not triggered by an exceedance of any of the following operating limits:Eli Lilly and Company-Tippecanoe Labs 4 th Significant Permit Modificati on No. 157-22717-00006 Page 116 of 226 Lafayette, Indiana Modified by: Aida De Guzman OP No. T157-6879-00006 Permit Reviewer: Dr. Trip Sinha

(1) Minimum combustion chamber temperature,

(2) Maximum hazardous waste feed rate, or

(3) Any hazardous waste combustor firing system operating limits.

The procedures for AWFCO event s specified in the O& M plan must include a statement that the ramp down must begin immediately upon initiation of automatic waste feed cutoff and must prescribe a bona fide ramping down.

(d) After an AWFCO event, the Permittee shall not restart the hazardous waste feed until the operating parameters and emission levels are within their respective limits.

(e) If after any AWFCO event, there is an exc eedance of an emission standard or operating requirement, irrespective of whether the ex ceedance occurred while hazardous waste remained in the combustion chamber, the Permittee shall:

(1) Investigate the cause of the AWFCO,

(2) Take appropriate corrective measures to minimize future AWFCOs, and

(3) Record the findings and corrective measures in the operating record.

D.13.9 Leak Detection and Repair (LDAR) Program [ 326 IAC 2-2-3, 40 CFR 63, Subpart DD, 40 CFR 61, Subpart V]

The LDAR standards that apply to components as sociated with the waste transfer/feed systems connected to the T149 rotary kiln incinerator are described in Section E.2 of this permit.

D.13.10 Inspection Requirem ents [and 40 CFR 63.1206(c)]

(a) In order to satisfy the HWC MACT standa rds [40 CFR 63.1206(c)(5)], the Permittee shall conduct daily visual inspections of the T149 rotary kiln incinerator to ensure the

combustion zone is sealed.

(b) In order to satisfy the HWC MACT sta ndards [40 CFR 63.1206(c)(3)(vii)], the Permittee shall test the AWFCO system and associated al arms at least once per week to verify operability, unless the operating record docum ents that the weekly inspections unduly restrict or upset operations and that less frequent inspection will be adequate. At a minimum, the Permittee shall conduct operability testing monthly.

D.13.11 Training and Certification Requ irements [40 CFR 63.1206(c)(6)]

(a) Pursuant to the HWC MACT standards [ 40 CFR 63.1206(c)(6)], the Permittee shall establish a Training and Certification Program for all categories of personnel whose activities may reasonably be expected to dire ctly affect emissions of HAPs from all operations associated with the T149 rotary kiln incinerator.

Said programs shall be of a technical level commensurate with the person’s duties as specified in the training manual. All operating training and certification programs shall be recorded in the operating record.

(b) A certified control room operator shall be on duty at the site at all times the T149 rotary kiln incinerator is in operation and the T149 rotary kiln incinerator, including associated air pollution control equipment and continuou s monitoring systems, shall be operated and maintained at all times by persons who are trained and certified according to the Training and Certification Program.Eli Lilly and Company-Tippecanoe Labs 4 th Significant Permit Modificati on No. 157-22717-00006 Page 117 of 226 Lafayette, Indiana Modified by: Aida De Guzman OP No. T157-6879-00006 Permit Reviewer: Dr. Trip Sinha

D.13.12 Plans and Procedures [326 IAC 2-2-3, 40 CFR 63.1206, 40 CFR 63.1211, 326 IAC 2-7-5(13)]

In order to satisfy the HWC MACT Standards [40 CFR 63.1206] and the PSD BACT requirements [326 IAC 2-2-3], the Permittee shall develop and implement the following written plans, which shall be maintained in the operating record:

(a) Operations and Maintenance (O&M) Plan – The O&M Plan shall define operations during periods of normal operation pursuant to 40 CFR 63.1206(c)(1) and (7).

(b) Startup, Shutdown, and Malfunction (SSM ) Plan – The SSM Plan shall be developed and implemented in accordance with 40 CFR 63.1206(c) (2), 40 CFR 63.6(e)(3), and 40 CFR 63.8(c), to ensure that the T149 rotary kiln incinerator, including associated air emission control equipment and CEMS and CMS, is operated and maintained in a manner which satisfies the general duty to minimize emi ssions established by 40 CFR 63.6(e)(1)(i), and

that all malfunctions are corrected as soon as practicable after their occurrence in order to minimize excess emissions. The SSM Plan shall contain the following information:

(1) Detailed procedures for operating and maintaining the T149 rotary kiln incinerator system, including associated CEMS and CMS equipment, during periods of startup, shutdown, and malfunction; and

(2) Corrective action program for malfun ctioning process, air pollution control, CEMS, and CMS equipment.

(c) Emergency Safety Vent (ESV) Operat ing Plan – The ESV Operating Plan shall be developed and implemented in accordance wi th 40 CFR 63.1206(c)(4). The emission standards and operating plans apply even if hazardous waste is in the combustion

chamber.

(d) Feedstream Analysis Plan – The Feedstream Analysis Plan shall be developed and implemented in accordance with 40 CFR 63. 1209(c)(2) for those parameters with feed
rate limits defined in Condition D.13.15.

(e) Continuous Emissions Monitoring System (CEMS) Standard Operating Procedures (SOP) – The Permittee shall prepare and im plement an SOP that provides step-by-step procedures and operations of the CEMS in accordance with 326 IAC 3-5-4(a) (9) – Preventive maintenance procedur es and corrective maintenance procedures that include those procedures taken to ensure continuous operation and to minimize malfunctions.

Testing and Monitoring Requirements [326 IAC 2-7-6(1) (6)] [326 IAC 2-7-5(1)]

D.13.13 Performance Test R equirements [40 CFR 63.1207, 3 26 IAC 2-1.1-11, 326 IAC 3-6]

The following streamlined performance test re quirements shall satisfy the NESHAP General Provisions [40 CFR 63.7], the HWC MACT requirements [40 CFR 63.1207 and 63.1209], the PSD BACT requirements for VOC and fluorides [326 IAC 2-1.1-11] and the State emission testing requirements [326 IAC 3-6]:

(a) Initial Comprehensive Performance Test Requirements:

(1) The Permittee shall submit a notificatio n of intention to conduct a comprehensive performance test and CMS performance evaluation and a site-specific test plan and CMS performance evaluation test plan at least one year before the performance test and performance evaluation are scheduled to begin.Eli Lilly and Company-Tippecanoe Labs 4 th Significant Permit Modificati on No. 157-22717-00006 Page 118 of 226 Lafayette, Indiana Modified by: Aida De Guzman OP No. T157-6879-00006 Permit Reviewer: Dr. Trip Sinha

(2) The Permittee shall perform initial comprehensive performance tests within 6 months following the initial introduction of hazardous waste in the rotary kiln incinerator unless an exemption is granted pursuant to 40 CFR 63.1207(e)(3).

(3) The Permittee shall submit a notification of intention to conduct the comprehensive performance test at least 60 calendar days before the test is scheduled to begin.

(4) The initial comprehensive tests sha ll be conducted under operating conditions representative of the extreme range of normal conditions as specified in 40 CFR 63.6(f)(2)(iii)(B) and 63.7(e)(1) for the wo rst case mode associated with each applicable pollutant limit or emission standard.

(5) The operating parameters defined in C ondition D.13.15 shall be monitored during the performance test to establish the parametric limits.

(6) All required comprehensive performance testing shall be completed within 60 days after the date of commencement of the tests pursuant to 40 CFR 63.1207(d)(3).

(7) The Permittee may use previous emissions test data in lieu of the initial comprehensive performance tests as allowed under 40 CFR 63.1207(c)(2).

(8) Pursuant to 40 CFR 63.7(h)(2), indivi dual performance tests may be waived upon written application to the Administrator if, in the Administrator’s judgment, the source is meeting the relevant standard(s ) on a continuous basis, or the source is being operated under an extension of compliance, or the owner or operator has requested an extensio n of compliance and the Administrator is still considering the request.

(9) Pursuant to 40 CFR 63.1207(j), the Permittee shall:

(A) Postmark a Notification of Compliance (NOC) documenting compliance or noncompliance with the emission standards and continuous monitoring system requirements and identify operating parameter limits under 40 CFR 63.1209 within 90 days of completion of the comprehensive performance test; and

(B) Comply with all operating requireme nts specified in the NOC in lieu of the limits specified in the Documentation of Compliance required under 40 CFR 63.1211(c) upon postmark of the NOC.

These submittal requirements satisfy t he reporting requirements of 326 IAC 3-6 as allowed under extension provisions of 326 IAC 3-6-4(b).

(b) Subsequent Comprehensive Performance Tests

(1) Pursuant to 40 CFR 63.1207(d)(4)(i), no subsequent comprehensive performance tests (includi ng DRE tests) shall be required until the U.S. EPA promulgates permanent replacement standards pursuant to the Settlement Agreement noticed in the Federal Regi ster on November 16, 2001, unless the Permittee modifies or otherwise alters op erations such that compliance with the
emission standards of Conditions D.13.2, D.13.5, and D.13.7 cannot be

achieved.

(2) Upon promulgation of the permanent re placement standards, the Permittee shall comply with the subsequent comprehens ive testing requirements established.Eli Lilly and Company-Tippecanoe Labs 4 th Significant Permit Modificati on No. 157-22717-00006 Page 119 of 226 Lafayette, Indiana Modified by: Aida De Guzman OP No. T157-6879-00006 Permit Reviewer: Dr. Trip Sinha

(c) Confirmatory Performance Tests

(1) Pursuant to 40 CFR 63.1207(d)(4)(ii), no confirmatory performance tests shall be required until the U.S. EPA promulgat es permanent replacement standards pursuant to the Settlement Agreement noticed in the Federal Register on November 16, 2001.

(2) Upon promulgation of the permanent re placement standards, the Permittee shall comply with the subsequent comprehens ive testing requirements established.

D.13.14 Continuous Emissions Monitoring System s (CEMS) Operating Requirements [40 CFR 60, Appendix B and Appendix F, 40 CFR 63.8, 326 IAC 2- 1.1-11, 326 IAC 3-5, Alternative Monitoring Petition initially approved January 27, 2006]]

(a) CO and O 2 CEMS Operation Requirements – The following requirements shall be applied at all times the T149 rotary kiln incinerator is in operation and represent the streamlined requirements of the HWC MACT standards fo r CO and HC [40 CFR 63.1209(a), (d), (e), (f), and (h)], PSD BACT requirements for CO and VOC [326 IAC 2-1.1-11], and the emission monitoring requirements for MACT and PSD sources [326 IAC 3-5-1(b) and (d)]:

(1) The Permittee shall install and operate the CO and O 2 CEMS in accordance with the QA requirements of the HWC MACT standards [40 CFR 63, Appendix to Subpart EEE], the applicable QC and performanc e evaluation requi rements of 40 CFR 63.1209(d), the applicable perform ance specification requirements of 40 CFR 60, Appendix B, and the Alternative Monitoring Petition (“AMP”) initially approved on January 27, 2006 and all s ubsequent revisions to the AMP.

(2) The CEMS shall be installed and operati onal upon certification of the DOC for the

HWC MACT.

(3) Continuous operation is defined as the collection of at least one measurement for each successive 15-second period, re gardless of startup, shutdown and

malfunction.

(b) SO 2 and NOx CEMS Operation Requirements – The following requirements shall apply when the T149 rotary kiln incinerator is burning waste:

(1) The Permittee shall install and operate the SO 2 and NOx CEMS in accordance with the QA/QC criteria set forth in 40 CFR 60, Appendix B, 40 CFR 60, Appendix F, Procedure 1, and the AMP approved on January 27, 2006.

(2) Continuous operation is defined as the collection of at least one measurement for each successive 15-minute period.

(3) The Startup, Shutdown, and Malf unction (SSM) Plan required by Condition D.13.12 (b) shall include procedures for monitoring and recording the following information during times of SO 2 or NOx CEMS malfunction:

(A) When the SO 2 CEMS malfunctions, the Permittee shall monitor and record the Hydro-SonicTM equivalent pressure drop and scrubber liquid flow rate as required by Conditi on D.13.15 (a)(3)(C) and (D) and the scrubber liquid pH as required by Condition D.13.15 (a)(5)(C).

(B) When the NOx CEMS malfunctions, the Permittee shall monitor and record the combustion chamber temperature, combustion air flow rate, and primary and secondary waste feed rates as required by Condition D.13.15 (a)(1), and assess NOx emissions, using waste testing, waste shipment and process knowledge, to determine whether the quantity ofEli Lilly and Company-Tippecanoe Labs 4 th Significant Permit Modificati on No. 157-22717-00006 Page 120 of 226 Lafayette, Indiana Modified by: Aida De Guzman OP No. T157-6879-00006 Permit Reviewer: Dr. Trip Sinha

nitrogen fed into the incinerator duri ng that time could have exceeded the worst case 24-hour daily average nitrogen feed rate of 1,379 pounds per
hour that formed the basis of the NOx BACT limit.

(c) Particulate Matter [PM] CEMS Alter native Operating Scenario Requirements – This permit provides the Permittee with t he following Alternative Operating Scenario for purposes of satisfying the monitoring require ments of 40 CFR 63.1209. The Permittee shall operate the PM CEMS at all times the T 149 Incinerator is in operation, except as provided in paragraphs (3) or (4) below.

(1) The Permittee shall install and operate the PM CEMS in accordance with the QA/QC criteria set forth the AMP approved on January 27, 2006, and all subsequent revisions to the AMP.

(2) Continuous operation is defined as the collection of at least one measurement for each successive 15-minute period. In or der to calculate a valid one-hour block average, valid results must be available for at least three of the four 15-minute cycles in each hour.

(3) During periods when the PM CEMS is malfunctioning or inoperative, the Permittee may use data from the Multi-Metal CEMS, as provided in the AMP approved January 27, 2006.

(4) In lieu of operating the PM CEMS, t he Permittee may satisfy the monitoring requirements of 40 CFR 63.1209 through operation of the Continuous Monitoring System requirements described in Section D.13.15(a).

(d) Multi-Metals [MMX] CEMS Alternat ive Operating Scenario Requirements – This permit provides the Permittee with t he following Alternative Operating Scenario for purposes of satisfying the monitoring requi rements of 40 CFR 63.1209. The Permittee shall operate the MMX CEMS at all times the T1 49 Incinerator is in operation, except as provided in paragraphs (3) or (4) below.

(1) The Permittee shall install and operate the MMX CEMS in accordance with the QA/QC criteria set forth the AMP approved on January 27, 2006, and all subsequent revisions to the AMP.

(2) Continuous operation is defined as the collection of at least one measurement for each successive 15-minute period. In or der to calculate a valid one-hour block average, valid results must be available for at least three of the four 15-minute cycles in each hour.

(3) During periods when the MMX CEMS is malfunctioning or inoperative, the Permittee may use data from the PM CEMS, as provided in the AMP approved on January 27, 2006 and all subsequent revisions to the AMP.

(4) In lieu of operating the MMX CEMS, t he Permittee may satisfy the monitoring requirements of 40 CFR 63.1209 through operation of the Continuous Monitoring System requirements described in Section D.13.15(a).

(e) Hydrogen Chloride [HCl] CEMS Alter native Operating Scenario Requirements – This permit provides the Permittee with t he following Alternative Operating Scenario for purposes of satisfying the monitoring requi rements of 40 CFR 63.1209. The Permittee shall operate the HCl CEMS at all times the T 149 Incinerator is in operation, except as provided in paragraphs (3) or (4) below.

(1) The Permittee shall install and operate the HCl CEMS in accordance with the QA/QC criteria set forth the AMP approved on January 27, 2006, and all subsequent revisions to the AMP.Eli Lilly and Company-Tippecanoe Labs 4 th Significant Permit Modificati on No. 157-22717-00006 Page 121 of 226 Lafayette, Indiana Modified by: Aida De Guzman OP No. T157-6879-00006 Permit Reviewer: Dr. Trip Sinha

(2) Continuous operation is defined as the collection of at least one measurement for each successive 15-minute period.

(3) In lieu of operating the HCl CEMS, t he Permittee may satisfy the monitoring requirements of 40 CFR 63.1209 through operation of the following Continuous Monitoring System requirements de scribed in Section D.13.15(a).

D.13.15 Parametric Continuous Monitoring System s (CMS) Requirements [40 CFR 63.8(c), 40 CFR 63.1209, and 326 IAC 2-1.1-11]

(a) The Permittee shall operate the following CM Ss in accordance with the quality assurance requirements specified in 40 CFR 63.1209(d) at all times the T149 incinerator is in operation. To satisfy the HWC MACT standards [40 CFR 63.1209(b), (d), (e), (f), and (h)] and the requirements for PSD sources [326 IAC 2-1.1-11], the following parameters shall

be monitored at all times the T149 incinerator is in operation. The permittee shall operate the CMS as provided in the table below. The CEMS mode is when the HCl CEMS, and

either the PM and/or the Metal CEMS are in operation in accordance with Condition D.13.14. If the permittee is not operati ng in CEMS mode, then the CMS in the

Parametric Mode must be monitored.

Operating Parameter Monitor

when in

CMS

Parametric

Mode Monitor

when in
CEMS

Mode Averaging

Period Units Parameter for

Maximum Primary Waste Feed to Primary
Combustion Chamber X X 1-hr RA lbs/hr D.13.5(e) D.13.5(f)

Maximum Secondary Waste Feed to Primary
Combustion Chamber X X 1-hr RA lbs/hr D.13.5(e) D.13.5(f)

Maximum Solid Feed Rate X X 1-hr RA lbs/hr D.13.5(e) D.13.5(f)

Minimum Primary
Combustion Chamber Temperature X X 1-hr RA o F D.13.5(e) D.13.5(f)

Maximum Primary Waste Feed to Secondary

Combustion Chamber X X 1-hr RA lbs/hr D.13.5(e) D.13.5(f)

Maximum Secondary Waste Feed to Secondary

Combustion Chamber X X 1-hr RA lbs/hr D.13.5(e) D.13.5(f)

Minimum Secondary

Combustion Chamber Temperature X X 1-hr RA o F D.13.5(e) D.13.5(f)

Maximum Stack Gas Flow

Rate X X 1-hr RA dscfm D.13.5(a) D.13.5(b) D.13.5(c) D.13.5(d) D.13.5(e) D.13.5(f)Eli Lilly and Company-Tippecanoe Labs 4 th Significant Permit Modificati on No. 157-22717-00006 Page 122 of 226 Lafayette, Indiana Modified by: Aida De Guzman OP No. T157-6879-00006 Permit Reviewer: Dr. Trip Sinha

Operating Parameter Monitor

when in

CMS

Parametric

Mode Monitor

when in
CEMS

Mode Averaging

Period Units Parameter for

Maximum waste feed viscosity X X Monthly Analysis Centipoise D.13.5(f)

Minimum Waste Atomizing Pressure X X 1-hr RA psig D.13.5(f)

Maximum Particulate Matter (PM) limit X 6-hr RA mg/dscm D.13.2(a)

Maximum HCl/Cl 2 emissions X 12-hr RA ppmv D.13.5(d)

Maximum Mercury

Emissions X 12-hr RA ug/dscm D.13.5(a)

Maximum SVM emissions X 12-hr RA ug/dscm D.13.5(b)

Maximum LVM Emissions X 12-hr RA ug/dscm D.13.5(c)

Maximum mercury feed

rate in all feed streams X 12-hr RA lbs/hr D.13.5(a)

Maximum SVM feed rate

in all feed streams X 12-hr RA lbs/hr D.13.5(b)

Maximum LVM feed rate

in all feed streams X 12-hr RA lbs/hr D.13.5(c)

Maximum LVM feed rate in all pumpable feed

streams X 12-hr RA lbs/hr D.13.5(c)

Maximum ash feed rate in

all feed streams X 12-hr RA lbs/hr D.13.2(a)

Maximum Total Chlorine

feed rate in all feed

streams X 12-hr RA lbs/hr D.13.5(d)

Minimum
Condenser/Absorber pressure drop X 1-hr RA in w.c. D.13.5(a) D.13.5(b) D.13.5(c) D.13.5(d)

Minimum
Condenser/Absorber liquid feed pressure X 1-hr RA psig D.13.5(a) D.13.5(b) D.13.5(c) D.13.5(d)

Minimum
Condenser/Absorber scrubber water pH X 1-hr RA pH D.13.5(d)

Minimum
Condenser/Absorber scrubber liquid flow rate X 1-hr RA gpm D.13.5(a) D.13.5(b) D.13.5(c) D.13.5(d)Eli Lilly and Company-Tippecanoe Labs 4 th Significant Permit Modificati on No. 157-22717-00006 Page 123 of 226 Lafayette, Indiana Modified by: Aida De Guzman OP No. T157-6879-00006 Permit Reviewer: Dr. Trip Sinha

Operating Parameter Monitor

when in

CMS

Parametric

Mode Monitor

when in
CEMS

Mode Averaging

Period Units Parameter for

Minimum Hydro-Sonic Scrubber Equivalent Pressure Drop X 1-hr RA in w.c. D.13.2(a) D.13.5(a) D.13.5(b) D.13.5(c) D.13.5(d)

Maximum Hydro-Sonic Scrubber conductivity X 12-hr RA % solids D.13.2(a) D.13.5 (a) D.13.5(b) D.13.5(c)

Minimum Hydro-Sonic Scrubber Liquid Feed

Rate X 1-hr RA gpm D.13.2(a) D.13.5(a) D.13.5(b) D.13.5(c) D.13.5(d)

Minimum Hydro-Sonic Scrubber water pH X 1-hr RA pH D.13.5(d)

(b) Continuous operation is defined as the co llection of at least one measurement for each successive 15-second period, regardless of startup, shutdown and malfunction.

(c) Pursuant to the HWC MACT standards [40 CFR 63.1209(a)(5)] and the compliance monitoring methods for PSD sources [326 IAC 2-1.1-11], the Permittee may petition the Administrator to use CEMS for compliance monitoring in lieu of compliance with the operating parameter limits established in (a) of this condition.

(d) If applicable, the Permittee may document co mpliance using the waiver provisions of 40 CFR 63.1207(m) in lieu of complying with (a) and (c) of this condition.

D.13.16 Fuel Oil Sampling and Analysis for SO 2 [326 IAC 2-1.1-11] [326 IAC 3-7-4]

Pursuant to 326 IAC 3-7-4, the Permittee sha ll maintain sampling and analysis certification

records of the fuel oil sulfur content in accordance with approved ASTM methods.

D.13.17 Minimum Data Requirements – SO 2 and NOx Compliance [326 IAC 2-1.1-11]

The following defines when CEMS data must be supplemented with data required by condition D.13.14 (b)(3), D.13.18 (a)(13), and D.13.19 (a)(2):

(a) When the period of incinerator operation (i.e., receiving waste streams) is 4 hours or greater in an operating day and monitoring data are insufficient to constitute a valid hour of data for at least 75 percent of the operating hours, or

(b) When the period of incinerator operation (i.e., receiving waste streams) is less than 4 hours in an operating day and more than one of the hours during the period of operation does not constitute a valid hour of data due to insufficient monitoring data.

(c) Monitoring data are insufficient to constitute a valid hour of data if measured values are unavailable for any of the required 15-minute periods within the hour.Eli Lilly and Company-Tippecanoe Labs 4 th Significant Permit Modificati on No. 157-22717-00006 Page 124 of 226 Lafayette, Indiana Modified by: Aida De Guzman OP No. T157-6879-00006 Permit Reviewer: Dr. Trip Sinha

Record Keeping and Reporting Requiremen t [326 IAC 2-7-5(3)] [326 IAC 2-7-19]

D.13.18 Record keeping Requirements

(a) The Permittee shall maintain the following records:

(1) Notifications, reports, and other do cuments, such as the Documentation of Compliance, as required by 40 CFR 63.1200, 63.1211(c), and 63.10(b) and (c).

(2) All data recorded by continuous monito ring systems (CMS), including continuous emission monitoring systems (CEMS), requi red by Conditions D.13.14, D.13.15, and D.13.17;

(3) Documentation that a change will not adversely affect compliance with the emission standards or operating requirements as required by 40 CFR 63.1206(b)(5)(ii);

(4) Records of the estimated hazardous waste residence time as required by 40 CFR 63.1206(b)(11);

(5) Plans and procedures as required by Condition D.13.12;

(6) Documentation of the results of the inve stigation, corrective measures taken, and

evaluation of excessive exceedances duri ng malfunctions as required by 40 CFR 63.1206(c)(2)(v)(A);

(7) Corrective Measures for any AWFCO that results in an exceedance of an applicable emission standard or operating parameter limit as required by 40 CFR 63.1206(c)(3)(v);

(8) Documentation and results of the AW FCO operability testing as required by Condition D.13.10 (b) and 40 CFR 63.1206(c)(3)(vii);

(9) Corrective measur es for any ESV opening as required by 40 CFR 63.1206(c)(4)(iii);

(10) Daily visual inspection records of the T149 rotary kiln incinerator to ensure the combustion zone is sealed as required by Condition D.13.10 (a) and 40 CFR 63.1206(c)(5);

(11) A copy of the Operator Certificati on and Training Program required by Condition D.13.11 and 40 CFR 63.1206(c)(6); and

(12) Documentation of the changes in m odes of operation as required by 40 CFR 63.1209(q).

(13) For days when condition D.13. 17 requires that CEMS data must be supplemented, the documentation of t he information required by Condition D.13.14 (b)(3).

(14) The time periods in which the Permittee is operating in CEMS mode as the primary monitoring scenario or the CMS systems described in D.13.15 as the primary monitoring scenario.

(b) The record keeping and reporting requirements for the LDAR standards are described in Section E.2 of this permit.

(c) The Permittee shall maintain quarterly record s of all fuel oil used in the T149 rotary kiln incinerator on a calendar month average basis, for the following:Eli Lilly and Company-Tippecanoe Labs 4 th Significant Permit Modificati on No. 157-22717-00006 Page 125 of 226 Lafayette, Indiana Modified by: Aida De Guzman OP No. T157-6879-00006 Permit Reviewer: Dr. Trip Sinha

(1) Sulfur content;

(2) Heat content;

(3) Fuel consumption; and

(4) Sulfur dioxide emission rate in pounds per MMBtu.

D.13.19 Reporting Requirements

(a) Quarterly Reporting Requirements

(1) The following streamlined quarterly repo rting requirements shall satisfy the HWC MACT standards [40 CFR 63.1211], wh ich references the MACT General Provisions [63.7-63.10], PSD BACT requirements [326 IAC 2-1.1-11], and the continuous emissions monitoring requirements [326 IAC 3-5]:

(A) Reports shall be submitted within 30 days following the reporting period using the reporting forms located at the end of this permit, or their equivalent;

(B) Summary reports of excess emis sions, parameter exceedances, and monitor downtime including informati on specified in 63.10(c)(5-(c)(13);

(C) SSM summary reports for the T149 rotary kiln incinerator control system, including associated CEMS and CMS equipment;

(D) Excessive exceedances report, if applicable, as required by 40 CFR 63.1206(c)(3)(vi); and

(E) Emergency safety vent opening reports as require by 40 CFR 63.1206(c)(4)(iv); and

(2) In addition to the requirements described in (a)(1) of this condition, the Permittee shall report the following information for the NOx and SO 2 CEMS to satisfy the PSD BACT requirements [326 IAC 2-1.1-11]:

(A) A list of days when condition D.13. 17 requires that CEMS data must be supplemented

(B) A detailed report for each day when condition D.13.17 requires that CEMS data must be supplemented that provides:

(i) the information required by Condition D.13.14 (b)(3), and

(ii) an analysis of whether that information indicates continuous compliance with the limit established in Condition D.13.3 or D.13.4, and if the NOx CEMS malfunctions for greater than six continuous hours, an assessment of NOx emissions using waste testing, waste shipment, and process knowledge whether the quantity of nitrogen fed into the incinerator during that time could have exceeded the worst case 24-hour daily average nitrogen feed rate of 1,379 pounds per hour that formed the basis of the
NOx BACT limit.Eli Lilly and Company-Tippecanoe Labs 4 th Significant Permit Modificati on No. 157-22717-00006 Page 126 of 226 Lafayette, Indiana Modified by: Aida De Guzman OP No. T157-6879-00006 Permit Reviewer: Dr. Trip Sinha

(b) Immediate Reporting Requirements

(1) The Permittee shall submit any revision to the SSM Plan that may significantly increase emissions of hazardous air pollu tants to the Administrator for approval within 5 days after making a change to the plan to satisfy the reporting requirements under the HWC MACT standa rds [40 CFR 63.1206(c)(2)(ii)(C)].

(2) The reporting requirements in the N ESHAP General Provisions for Startup, Shutdown and Malfunction (SSM) Plans [ 40 CFR 63.6(e)(3)] shall be used to satisfy the reporting requirements unde r the HWC MACT standards [40 CFR 63.1206(c)(2)] and PSD BACT require ments [326 IAC 2-1.1-11].

(A) The Permittee shall report all actions taken during T149 incinerator system SSM event that results in an exceedance of a relevant emission standard when those actions are in consistent with the procedures specified in the SSM Plan. The immediate report shall be submitted to the agency via a telephone call or facsimile within 2 working days after commencing actions inconsistent with the plan.

(B) Within 7 working days after the end of an SSM event where an action taken by the Permittee is not consistent with the procedures specified in the SSM Plan, the Permittee shall submit a letter containing the following information in accordance with 40 CFR 63.10(d)(5):

(i) Name, title and signature of responsible official certifying

accuracy;

(ii) Explanation of the ci rcumstances of the event;

(iii) Reason for not following the SSM Plan; and

(iv) Report any excess emissions and/or parameter monitoring

exceedances are believed to have occurred.

Modifications and Construction Requirements [326 IAC 2-7-10.5, 326 IAC 2-7-12 and 326 IAC 2-2]

D.13.20 Modifications and Construction: Ad vance Approval of Permit Conditions

(a) The Permittee may modify any existing emissi on units listed in this section of the permit without obtaining a source modification appr oval (otherwise required by 326 IAC 2-7- 10.5), a Title V permit modification (otherwise required by 326 IAC 2-7-12), or a Prevention of Significant Deterioration permit (otherwise required by 326 IAC 2-2), provided the modified emission units are s ubject to the same applicable requirements listed in this D section, and the Permittee shall comply with the Change Management and Flexible Permit provisions in Section F.1 of this permit.

(b) The Permittee may construct and install new em ission units of the types described in this D section without obtaining a source modifica tion approval (otherwise required by 326 IAC 2-7-10.5), a Title V permit modification (otherwise required by 326 IAC 2-7-12), or a Prevention of Significant Deterioration permit (otherwise required by 326 IAC 2-2), provided the new emission units are subject to the same applicable requirements listed in this D section, and the Permittee shall comply with the Change Management and Flexible Permit provisions in Section F.1 of this permit.Eli Lilly and Company-Tippecanoe Labs 4 th Significant Permit Modificati on No. 157-22717-00006 Page 127 of 226 Lafayette, Indiana Modified by: Aida De Guzman OP No. T157-6879-00006 Permit Reviewer: Dr. Trip Sinha

SECTION D.14 BPM CONTRO L SYSTEMS – RTO OPERATIONS

Facility Description [326 IAC 2-7-5(15)]

The information describing the proc esses contained in the following facility de scription is descriptive

information and does not constitute enforceable conditions:

(a) The following emissions units are subject to applicable requirements described in this D section:

Emission Unit Description Building Stack/Vent Nominal Capacity Control Device

Regenerative Thermal Oxidizer 1 (RTO1) RTO1 RTO1 Stack 36 MMBtu/hr Caustic Scrubber System

Regenerative Thermal Oxidizer 2 (RTO2) RTO2 RTO2 Stack 36 MMBtu/hr Caustic Scrubber System

The RTO control system consists of two Regener ative Thermal Oxidizers, identified as RTO1 and RTO2, each equipped with caustic scrubbing system s and each exhausting to individual stacks.

The closed vent system (CVS) associated with t he RTO control system begins at the outlet of the production building roof fans exhausting to the RTO fume transport system and at the outlet side

of the tank conservation vents of those tank modules exhausting to the RTO fume transport system and ends at the entranc e of the RTO control system.

Emission Limitations and Sta ndards [326 IAC 2-7-5(1)]

D.14.0 Requirement to Control Emissions [40 CFR 60 Subpart Kb, 40 CFR 63 Subpart GGG, 40 CFR 63 Subpart DD, 326 IAC 2-2- 3, and 326 IAC 8-5-3]

Except for equipment excluded from emission c ontrol requirements and except as otherwise provided by statute or rule, or in this permi t, the fumes from all emission units which reference this section shall be continuously routed to the RTO control system while emission units vented to the control equipment are in operation. Except as otherwise provided by statute or rule, or in this permit

, the RTO control system shall be operated at a ll times that the emission units vented to the control equipment are in operation.

D.14.1 Control Device and Closed Vent System Standar ds [40 CFR 63.1253(b), (c), and (d), 63.1254(a) and (c), 63.1256(b), (e), and (h), 63.1258(b), 40 CFR 63.685(c) and (d), 63.689(b), 63.690(b), 63.693(f), 40 CFR 60.112b(a) and 60.113b(c) , 326 IAC 2-2-3, and 326 IAC 8-5-3(b)]

(a) RTO Control Device Standards – The RTO control device standards shall apply at all times the unit is burning waste fume streams, except as provided in Condition D.14.2 (a):

(1) Carbon Monoxide (CO) – In order to satisfy PSD BACT requirements [326 IAC 2- 2-3], CO emissions at the outlet of t he RTO system shall not exceed a 24-hour daily average of 73 parts per million by volume (ppmv).

(2) Oxides of Nitrogen (NOx) – In order to satisfy PSD BACT requirements [326 IAC 2-2-3], NOx emissions at the outlet of the RTO system shall not exceed a 24- hour daily average of 91 ppmv.Eli Lilly and Company-Tippecanoe Labs 4 th Significant Permit Modificati on No. 157-22717-00006 Page 128 of 226 Lafayette, Indiana Modified by: Aida De Guzman OP No. T157-6879-00006 Permit Reviewer: Dr. Trip Sinha

(3) Sulfur Dioxide (SO 2 ) – In order to satisfy PSD BACT requirements [326 IAC 2-2- 3], SO 2 emissions, as measured at the outl et of the RTO system, shall not exceed a 24-hour daily average of 100 ppmv.

(4) Volatile Organic Compounds (VOC)/Volatile Organic Hazardous Air Pollutant (VOHAP) – In order to satisfy the Phar maceutical MACT requirements [40 CFR 63.1253(b), (c), and (d), 63.1254(a) and (c), and 63.1256(b), (e) and (h), and 63.1258(b)], the Offsite Waste and Recovery Operations MACT requirements [40 CFR 63.685(c) and (d), 63.689(b), 63.690(b), and 63.693(f)], the PSD BACT requirements [326 IAC 2-2-3], the Synthe tic Pharmaceutical RACT requirements [326 IAC 8-5-3(b)], and the New Source Performance Standards for Volatile Organic Liquid Storage Vessel requ irements [40 CFR 60.112b(a) and 60.113b(c)], the Permittee shall meet one of the following streamlined
VOC/VOHAP emission standards:

(A) Concentration Emission Standard:

(i) The VOC/VOHAP emissions shall not exceed 20 ppmv over a 24-hour daily average at the outle t of the RTO system, measured via a TOC CEMS;

(ii) The RTO combustion chamber temperature shall not be less than 1500F over a 24-hour daily average; and

(iii) The RTO combustion chamber residence time shall not be less

than 0.75 seconds over a 24-h our daily average, which is equivalent to a maximum 24-hou r daily average stack exhaust air flow rate of 3340 standard cubic feet per second; or

(B) Control Efficiency Emission Standard:

(i) The VOC/VOHAP emissions shall be reduced by a control efficiency of 98% or more at the outlet of the RTO system;

(ii) The RTO combustion chamber temperature shall not be less than 1500F over a 24-hour daily average; and

(iii) The solvent concentration going to the RTO, measured as a percent of the lower explosive lim it (LEL), shall not exceed a 24- hour daily average established from a compliant stack test.

The Permittee shall conduct a performance test for TOC before the control efficiency monitoring approach is used to assess compliance with this control efficiency standard

(5) Hydrogen Halide/Halogen and Fluorides – In order to satisfy the Pharmaceutical MACT requirements [40 CFR 63.1253(b), (c), and (d), 63.1254(a) and (c), 63.1256(b), (e) and (h), and 63.1258(b)] and PSD BACT requirements for fluorides [326 IAC 2-2-3], the Permittee shall meet one of the following hydrogen halide and halogen emission standards:

(A) Concentration Emission Standard:

(i) The hydrogen halide and halogen emissions, which includes hydrogen fluoride emissions, shall not exceed 20 ppmv over a 24-hour daily average at the outle t of the RTO system, measured via a HCl CEMS; orEli Lilly and Company-Tippecanoe Labs 4 th Significant Permit Modificati on No. 157-22717-00006 Page 129 of 226 Lafayette, Indiana Modified by: Aida De Guzman OP No. T157-6879-00006 Permit Reviewer: Dr. Trip Sinha

(B) Control Efficiency Emission Standard:

(i) The hydrogen halide and halogen emissions, which include hydrogen fluoride emissions, s hall be reduced by a control efficiency of 98% or more at the outlet of the RTO system;

(ii) The 24-hour daily average sc rubber liquid pH of the caustic scrubbing system shall not be less than the value established from a compliant stack test;

(iii) The 24-hour daily average scrubb er liquid recirculation flow rate of the caustic scrubbing system shall not be less than the value established from a compliant stack test; and

(iv) The 24-hour daily average scr ubber caustic flow rate of the caustic scrubbing system shall not exceed the value established from a compliant stack test.

The Permittee shall conduct a performance test for HCl before the control efficiency monitoring approach is used to assess compliance with this control efficiency standard.

(b) RTO Closed Vent System Inspection Standards – The following inspection standards shall apply to the RTO closed vent system (C VS), except as provided in Condition D.14.2 (b):

(1) The Permittee shall comply with the following closed vent system inspection requirements to satisfy the Pharmace utical MACT requirements [40 CFR 63.1256(b)(3) and (e)(1) and 63.1258(h)], the Offsite Waste MACT requirements [40 CFR 63.685(g), 63.689(b), 63.690(b) , 63.693(b) and (c), and 63.695(c)], and the PSD BACT requirements [326 IAC 2-2-3]:

(A) Initial one-time Method 21 inspections shall be conducted on new portions of the RTO closed vent system not operated under negative pressure within 150 days after start up, if not subject to the LDAR requirements established in Section E of this permit.

(B) Portions of the CVS that are oper ated under negative pressure shall be equipped with a pressure gauge or other pressure measurement/ detection. The data output must be viewable from a readily accessible location to verify that negative pressure is being maintained when waste fume streams are going to the control system.

(C) Annual visual inspections of t he RTO closed vent system shall be performed for visible cracks, holes or gaps, loose connections, and broken or missing caps.

(D) Repair of any leak detected on the RTO closed vent system shall be initiated no later than 5 calendar days after identification, and completed within 15 days after identification, unless:

(i) The repair is technically infeasible without a shutdown of an operation or process; or

(ii) It is determined that emissions resulting from immediate repair would be greater than the fugitive emissions likely to result from delay of repair.Eli Lilly and Company-Tippecanoe Labs 4 th Significant Permit Modificati on No. 157-22717-00006 Page 130 of 226 Lafayette, Indiana Modified by: Aida De Guzman OP No. T157-6879-00006 Permit Reviewer: Dr. Trip Sinha

Repairs delayed due to either of the ca uses described in (A) or (B) shall be completed by the end of the next shutdown.

(2) The Permittee shall monitor each bypa ss line on the RTO closed vent system to satisfy the Pharmaceutical MACT requi rements [40 CFR 63.1252(b), 63.1253(b) and (c), and 63.1258(b)], the Offsite Waste MACT requirements [40 CFR 63.685(g), 63.689(b), 63.690(b), and 63.693(c)], and the PSD BACT requirements [326 IAC 2-2-3] using one of the following methods:

(A) Install and monitor the position of t he closed vent system bypass valve at least once every 15 minutes, where the closed position means there is no bypass flow; or

(B) Secure the bypass line valve in the closed position with a car seal or lock and key type configuration. Monthly vis ual inspections of seal or locking device shall be performed to ensure the s eal is not broken or the valve is in the closed position and the vent st ream is not diverted through the bypass line.

D.14.2 Exceptions to RTO Control System St andards [40 CFR 63.1260(g), 40 CFR 63.6(e)(3) and 63.8(c), and 40 CFR 63.681, 63.685(g ), 63.693(b) and 326 IAC 2-2-3]

(a) Exceptions to RTO Control Device Oper ational Standards – The following streamlined standards satisfy the Pharmaceutical MACT standards [40 CFR 63.1260(g)], Offsite Waste MACT standards [40 CFR 63.681, 63.685(g) and 63.693(b)], and PSD BACT requirements [326 IAC 2-2-3]:

(1) The Permittee may open a safety device and bypass the RTO system at any time conditions require it to do so to avoid unsafe conditions.

(2) The provisions of Conditions D.14.1 (a ) shall not apply during periods of startup, shutdown or malfunction that preclude the Permittee from complying with Condition D.14.1 (a), provided the Permi ttee complies with the provisions of the startup, shutdown, and malfunction pl an (SSM Plan) required by Condition

D.14.3.

(b) Exceptions to RTO Closed Vent Syst em Inspection Standards – The following streamlined standards satisfy the Phar maceutical MACT standards [40 CFR 63.1258(h)(6) and (7)], and PSD BACT requirements [326 IAC 2-2-3]:

(1) The Permittee is not required to insp ect if unsafe or difficult to inspect.

D.14.3 Startup, Shutdown, and Malfunction Requirements for RTO Control System [40 CFR 63.1259(a)(3), 40 CFR 63.697(b)(3), 40 CFR 63.6 (e)(3), 40 CFR 63.8(c) and 326 IAC 2-2-3]

(a) The NESHAP General Provisions for Star tup, Shutdown and Malfunction (SSM) Plans [40 CFR 63.6(e)(3)] shall be used to sati sfy the Pharmaceutical MACT standards [40 CFR 63.1259(a)(3)], Offsite Waste MACT standards [40 CFR 63.697(b)(3)], and PSD BACT requirements [326 IAC 2-2.1.11].

(b) Pursuant to 40 CFR 63.6(e)(3), the Permi ttee shall develop an SSM Plan to ensure that the RTO control system, including associated CEMS and CMS equipment, is operated and maintained in a manner which satisfies the general duty to minimize emissions established by 40 CFR 63.6(e)(1)(i), and that all malfunctions are corrected as soon as practicable after their occurrence in order to minimize excess emissions. The SSM Plan shall contain the following information:Eli Lilly and Company-Tippecanoe Labs 4 th Significant Permit Modificati on No. 157-22717-00006 Page 131 of 226 Lafayette, Indiana Modified by: Aida De Guzman OP No. T157-6879-00006 Permit Reviewer: Dr. Trip Sinha

(1) Detailed plans and/or procedures for op erating and maintaining the RTO system, including associated CEMS and CMS equipment, during periods of startup, shutdown, and malfunction; and

(2) Corrective action program for malfunctioning air pollution control, CEMS, and CMS equipment.

Compliance Determination Requirements

D.14.4 Requirement to Control Emissions [40 CFR 60 Subpart Kb, 40 CFR 63 Subpart GGG, 40 CFR 63 Subpart DD, 326 IAC 2-2- 3, and 326 IAC 8-5-3]

Except for equipment excluded from emission c ontrol requirements and except as otherwise provided by statute or rule, or in this permit, the RTO control system shall be operated at all times that the emission units vented to the control equipment are in operation.

Testing and Monitoring Requirements [326 IAC 2-7-6(1) (6)] [326 IAC 2-7-5(1)]

D.14.5 Continuous Emissions Monitoring System (CEMS) Requirements [40 CFR 60, Appendix B and Appendix F, 40 CFR 60.113b(c), 40 CFR 63.1258(b) , 40 CFR 63.693(f), 40 CFR 63.8, 326 IAC 2- 1.1-11, 326 IAC 2-7-24, 326 IAC 3-5]

(a) CO, NOx, and SO 2 CEMS Operation Requirements –The following requirements shall apply when the RTO is burning waste fume streams:

(1) The Permittee shall install and operate the CO, NOx, and SO 2 CEMS in accordance with the quality assurance/qualit y control (QA/QC) criteria set forth in 40 CFR 60, Appendix B, and 40 CFR 60, Appendix F, Procedure 1.

(2) Continuous operation is defined as the collection of at least one measurement for each successive 15-minute period.

(3) The Startup, Shutdown, and Malfuncti on (SSM) Plan required by Condition D.14. 3 (b) shall include procedures for monitoring and recording the following information during times of CO or SO 2 or NOx CEMS malfunction:

(A) When the SO 2 CEMS malfunctions, the Permittee shall monitor and record the scrubber liquid recirculation flow rate and caustic flow rate as required by Condition D.14. 6(b)(1) (A) and (B) respectively and the scrubber liquid pH as required by Condition D.14.6 (b)(1)(C).

(B) When CO CEMS malfunctions, the Permittee shall monitor and record the RTO combustion chamber temperature, and exhaust airflow rate from the RTO as required by D.14.6 (a)(1) and (3), respectively.

(C) When the NOx CEMS malfunctions, the Permittee shall monitor and record the combustion chamber temperature and exhaust airflow rate from the RTO as required by D.14. 6 (a) (1) and (3), and assess NOx emissions, using process knowledge, to determine whether the quantity of nitrogen fed into the RTOs during that time could have exceeded the worst case 24-hour daily average nitrogen feed rate of 1, 085 pounds per
hour that formed the basis of the NOx BACT limit.

(b) TOC CEMS Operation Requirements –The following requirements shall apply only when burning waste fume streams and represent the streamlined requirements of the Pharmaceutical MACT standards [40 CFR 63. 1258(b)], Offsite Waste MACT standards [40 CFR 63.693(f)], NESHAP General Provis ions monitoring requirements [40 CFR 63.8(c)], NSPS Volatile Organic Liquid Storage Vessel requirements [40 CFREli Lilly and Company-Tippecanoe Labs 4 th Significant Permit Modificati on No. 157-22717-00006 Page 132 of 226 Lafayette, Indiana Modified by: Aida De Guzman OP No. T157-6879-00006 Permit Reviewer: Dr. Trip Sinha

60.113b(c)], PSD BACT requirements for VO Cs [326 IAC 2-1.1-11], and emission monitoring requirements for MACT and PSD sources [326 IAC 3-5-1(b) and (d)]:

(1) The Permittee shall install and operate the CEMS in accordance with the QA/QC criteria set forth in 40 CFR 60, A ppendix B, 40 CFR 63.1258(b)(1)(x), and 40

CFR 63.8.

(2) Continuous operation is defined as the collection of at least one measurement for each successive 15-minute period.

(c) HCl CEMS Operation Requirements – The following requirements shall apply only when burning waste fume streams and represent streamlined requirements for the
Pharmaceutical MACT standards for hydrogen halides and halogens [40 CFR 63.1258(b)], NESHAP General Provisions moni toring requirements [40 CFR 63.8(c)], and PSD BACT requirements for fluorides [326 IAC 2-1.1-11]:

(1) The Permittee shall install and operate the HCl CEMS in accordance with the performance and QA/QC criteria established in the Updated Alternative Monitoring Plan for Hydrogen Chloride C ontinuous Emission Monitoring Systems for the Regenerative Thermal Oxidizers submitted to EPA OAQPS on August 15, 2003, as allowed by 40 CFR 63.1258(b) and 40 CFR 63.8.

(2) Continuous operation is defined as the collection of at least one measurement for each successive 15-minute period.

(d) CEMS Standard Operating Procedures (SOP) - The Permittee shall prepare and implement an SOP that provides step-by-step procedures and operations in accordance with 326 IAC 3-5-4(a) (9) – Preventive ma intenance procedures and corrective maintenance procedures that include thos e procedures taken to ensure continuous operation and to minimize malfunctions.

D.14.6 Performance Testing Requirements [40 CFR 60.113b(c), 40 CFR 63.7, 40 CFR 63.1257(b), (c), and (d) and 63.1258(b)(3), 40 CFR 63.693(f), 326 IAC 3-6-3(c), 326 IAC 2-7-24, and 326 IAC 2- 1.1-11]

(a) Initial Comprehensive Performance Test Requirements:

(1) VOC/VOHAP – When applying the contro l efficiency standard, the following streamlined requirements shall apply only when burning waste fume streams to satisfy the Pharmaceutical MACT standa rds [40 CFR 63.1257(b), (c), and (d) and 63.1258(b)], Offsite Waste MACT standard s [40 CFR 63.693(f)], Volatile Organic Liquid Storage Vessel requirements [40 CFR 60.113b(c)], PSD BACT requirements [326 IAC 2-1.1-11], and emission testing requirements for MACT sources [326 IAC 3-6-3(c)]:

(A) Prior to applying the control efficiency emission standard, the Permittee shall conduct an initial performance test in accordance with the methods
set forth in 40 CFR 63.1257.

(B) The Permittee shall submit a notification of the performance test and a site-specific test plan at least 60 days in advance of the intended performance test date.

(C) The operating parameters defined in Condition D.14.1 (a)(4)(B) shall be monitored during the performance test to establish the 24-hour daily average parametric limits, accordi ng to the requirements of 40 CFR 63.1258(b)(3).Eli Lilly and Company-Tippecanoe Labs 4 th Significant Permit Modificati on No. 157-22717-00006 Page 133 of 226 Lafayette, Indiana Modified by: Aida De Guzman OP No. T157-6879-00006 Permit Reviewer: Dr. Trip Sinha

(D) The Permittee shall submit the performance test reports, and upon request, the CMS performance evaluation, within 45 days following the test. The Permittee is allowed an extension if a reasonable explanation is provided within 40 days following the test.

(2) Hydrogen Halide/Halogen – When applying the control efficiency standard, the following requirements shall apply only when burning waste fume streams to satisfy the Pharmaceutical MACT sta ndards [40 CFR 63.1258(b)] and the PSD BACT requirements for fluorides [326 IAC 2-1.1-11]:

(A) Prior to applying the control efficiency emission standard, the Permittee shall conduct an initial performance test in accordance with the methods
set forth in 40 CFR 63.1257.

(B) The Permittee shall submit a notification of the performance test and a site-specific test plan at least 60 days in advance of the intended performance test date.

(C) The operating parameters defined in Condition D.14.1 (a)(5)(B) shall be monitored during the performance test to establish the 24-hour daily average parametric limits, accordi ng to the requirements of 40 CFR 63.1258(b)(3).

(D) The Permittee shall submit the performance test reports, and upon request, the CMS performance evaluation, within 45 days following the test. The Permittee is allowed an extension of 15 days if a reasonable explanation is provided within 40 days following the test.

(b) Subsequent Comprehensive Performance Test Requirements:

If the Permittee is complying with the control efficiency emission standards for VOC/VOHAP and Hydrogen Halide/Halogens, the performance tests shall be repeated at least once every fifth year from the dat e of the most recent valid compliance

demonstration.

D.14.7 Parametric Continuous Monitoring System (CMS) Requirements [40 CFR 63.8(c), 40 CFR 60.113b(c), 40 CFR 63.1257(b), 63.1258(a) and (b ), and 63.1260(e), 40 CFR 63.693(b), 326 IAC 2-1.1-11, 326 IAC 2-7-24, and 326 IAC 3-5-5(d)]

(a) VOC/VOHAP CMS Operation Requirements - The following streamlined requirements shall apply only when burning waste fume st reams to satisfy the Pharmaceutical MACT standards [40 CFR 63.1258(a) and (b)], Offsite Waste MACT standards [40 CFR 63.693(b)], Volatile Organic Liquid Storage Vessel requirements [40 CFR 60.113b(c)], PSD BACT requirements [326 IAC 2-1.1-11], and continuous monitoring requirements for flow rate [326 IAC 3-5-5(d)]:

(1) RTO Combustion Chamber Temperature – The Permittee shall install and operate the RTO combustion chamber temp erature CMS in accordance with 40 CFR 63.8(c).

(2) Lower Explosive Level (LEL) Conc entration – When applying the VOC/VOHAP control efficiency standard, the Permi ttee shall install and operate the LEL CMS in accordance with 40 CFR 63.8(c).

(3) Flow Rate Monitor – When applying the VOC/VOHAP concentration emission standard, the Permittee shall install and operate airflow rate CMS at the stack exhaust in accordance with 326 IAC 3-5-5(d).Eli Lilly and Company-Tippecanoe Labs 4 th Significant Permit Modificati on No. 157-22717-00006 Page 134 of 226 Lafayette, Indiana Modified by: Aida De Guzman OP No. T157-6879-00006 Permit Reviewer: Dr. Trip Sinha

(4) Continuous operation is defined as the collection of at least one measurement for each successive 15-minute period.

(b) Hydrogen Halide/Halogen and Fluorides CM S Requirements – When applying the control efficiency standard requirements shall apply only when burning waste fume streams:

(1) The Permittee shall install and operate the following CMSs in accordance with 40 CFR 63.8(c):

(A) Scrubber liquid pH monitor;

(B) Scrubber liquid recirculation flow rate monitor; and

(C) Scrubber caustic flow rate monitor.

(2) Continuous operation is defined as the collection of at least one measurement for each successive 15-minute period.

(c) CMS Standard Operating Procedure (SOP) – The Permittee shall prepare and implement a SOP for the CMS units in accordance with 40 CFR 63.8(d).

D.14.8 Excursions [40 CFR 63.1258(b)(6), 40 CFR 63.695(e)(4)]

(a) Pursuant to the Pharmaceutical MACT stand ards [40 CFR 63.1258(b)(7)] and the Offsite Waste MACT [40 CFR 63.695(e) (4)], excursions are defined as follows and apply to the CEMS and CMS required by Conditions D.14.4 (b) and (c), and D.14.6, respectively:

(1) When the period of control device operat ion (i.e., receiving waste fume streams) is 4 hours or greater in an operating day and monitoring data are insufficient to

constitute a valid hour of data for at least 75 percent of the operating hours.

(2) When the period of control device operat ion (i.e., receiving waste fume streams) is less than 4 hours in an operating day and more than one of the hours during the period of operation does not constitute a valid hour of data due to insufficient monitoring data.

(b) A valid hour requires at least one data point for each 15-minute period in the operating

hour.

D.14.9 Minimum Data Requirements – SO 2, CO, and NOx Compliance [326 IAC 2-1.1-11]

The following defines when CEMS data must be su pplemented with data required by conditions D.14. 4 (a)(3), D.14.9 (a)(1)(L), and D.14.9 (b)(2):

(a) When the period of RTO operation (i.e., rece iving waste streams) is 4 hours or greater in an operating day and monitoring data are insufficient to constitute a valid hour of data for at least 75 percent of the operating hours, or

(b) When the period of RTO operation (i.e., rece iving waste streams) is less than 4 hours in an operating day and more than one of the hours during the period of operation does not constitute a valid hour of data due to insufficient monitoring data.

(c) Monitoring data are insufficient to constitute a valid hour of data if measured values are unavailable for any of the required 15-minute periods within the hour.Eli Lilly and Company-Tippecanoe Labs 4 th Significant Permit Modificati on No. 157-22717-00006 Page 135 of 226 Lafayette, Indiana Modified by: Aida De Guzman OP No. T157-6879-00006 Permit Reviewer: Dr. Trip Sinha

Record Keeping and Reporting Requiremen t [326 IAC 2-7-5(3)] [326 IAC 2-7-19]

D.14.10 Record Keeping and Reporting Requirements

(a) Record Keeping Requirements

The Permittee shall maintain the following records:

(1) Control Device (RTO) Records – The following streamlined record keeping requirements satisfy the Pharmaceutical MACT requirements [40 CFR 63.1259], the Offsite Waste MACT standards [40 CF R 63.696], Volatile Organic Liquid Storage Vessel requirements [40 CFR 60.115b], PSD BACT requirements [326 IAC 2-1.1-11 and 326 IAC 2-7-5(3)], and t he continuous emission monitoring and performance testing requirements [326 IAC 3-5 and 3-6]:

(A) Log of the operating scenario (i.e ., concentration standard or control efficiency standard) applied to satisfy the VOC/VOHAP and hydrogen halide and halogen emission standards required by Conditions D.14.1 (a)(4) and D.14.1 (a)(5) in an On-Site Implementation Log (OSIL);

(B) Records of the current and superseded versions of SSM Plan;

(C) Description of worst-case operating conditions, if comp lying with control efficiency standard;

(D) Results of control device perf ormance tests and CMS performance evaluations, if complying with control efficiency standard;

(E) Records of all required CMS and CEMS data;

(F) Records of each CMS and CEMS calibration checks;

(G) Maintenance records for each control device, CMS, and CEMS;

(H) Occurrence/duration records of ea ch control device malfunction, CMS malfunction, and CEMS malfunction;

(I) Information to demonstrate conformance with each SSM is consistent with procedures in the SSM Plan;

(J) Records of actions taken during each SSM when different from SSM Plan; and

(K) Record of the current standard operating procedure (SOP) for the RTO

CEMS and CMS units.

(L) For days when condition D.14.8 requires that CEMS data must be supplemented, the documentation of the information required by Condition D.14.4 (a)(3).

(2) Closed Vent System (RTO CVS) Records – The following streamlined record keeping requirements satisfy the Pharma ceutical MACT requirements [40 CFR 63.1259], the Offsite Waste MACT standa rds [40 CFR 63.696], Volatile Organic Liquid Storage Vessel requirements [40 CFR 60.115b], PSD BACT requirements [326 IAC 2-1.1-11 and 326 IAC 2-7-5(3)], and the continuous emission monitoring and performance testing requirements [326 IAC 3-5 and 3-6]:Eli Lilly and Company-Tippecanoe Labs 4 th Significant Permit Modificati on No. 157-22717-00006 Page 136 of 226 Lafayette, Indiana Modified by: Aida De Guzman OP No. T157-6879-00006 Permit Reviewer: Dr. Trip Sinha

(A) Hourly records of bypass flow indi cator operating status and the time and

duration of all diversions detected by the bypass flow indicator, if complying via this method;

(B) Monthly visual inspection reco rds of bypass line valves and the occurrence of all periods the valve position has changed, if complying via this method;

(C) Record each CVS component that is unsafe to inspect, and a plan for inspecting the component as frequent ly as practicable during safe-toinspect times;

(D) Record each CVS component that is difficult to inspect and a written plan for inspecting the component at least once every five years;

(E) Record the following information if no leaks are detected during applicable Method 21 inspections and CVS annual visual inspections:

(i) Date each inspection was performed; and

(ii) Statement for each inspecti on that no leaks were detected.

(F) For each part of the CVS not operated under negative pressure, record the following information for all leaks detected during the initial Method 21 inspection:

(i) Identification of leaking equipment;

(ii) Instrument ID and operator name or initials;

(iii) Date the leak was detected and date of first attempt to repair leak;

(iv) Maximum instrument reading after leak from initial Method 21 is successfully repaired or de clared non-repairable; and

(v) Record of reason for any del ay of repair, name of person responsible for decision, expect ed date of repair, dates of shutdowns when repair is made and date of successful repair of

leak.

(G) Record the following information for all leaks detected from the CVS annual visual inspection:

(i) Identification of leaking equipment;

(ii) Date leak was detected and first attempt to repair leak; and

(iii) Record of reason for any delay of repair, name of person responsible for decision, expect ed date of repair, dates of shutdowns when repair is made and date of successful repair of

leak.

(b) Quarterly Periodic Reports

(1) The following streamlined reporting re quirements satisfy the Pharmaceutical MACT requirements [40 CFR 63.1260 (g)] and the Offsite Waste MACT standards [40 CFR 63.697], which reference the MACT General Provisions [40 CFR 63.7 – 63.10], Volatile Organic Liquid Storage Vessel requirements [40 CFREli Lilly and Company-Tippecanoe Labs 4 th Significant Permit Modificati on No. 157-22717-00006 Page 137 of 226 Lafayette, Indiana Modified by: Aida De Guzman OP No. T157-6879-00006 Permit Reviewer: Dr. Trip Sinha

60.115b], PSD BACT requirements [326 IAC 2-1.1-11], and the continuous emission monitoring requirements [326 IAC 3-5]:

(A) Reports shall be submitted within 30 days following the reporting period using the reporting forms located at the end of this permit, or their equivalent;

(B) If total duration of excess emi ssions, parameter exceedances, or excursions is 1% or greater of total operating time OR total CMS downtime is greater than 5% for reporting period, include:

(i) 15-minute data and daily averages for all operating days out of

range;

(ii) duration of excursions; and

(iii) operating logs and scenarios fo r all operating days out of range;

(C) Summary reports of excess em issions, parameter exceedances, percentage of excursions and monitor downtime including information specified in 63. 10(c)(5)-(c)(13);

(D) Report, when applicable, no exce ss emissions, no exceedances, no excursions, and no CMS have been inoperative, out of control, repaired or adjusted;

(E) For CVS bypass lines with flow indicator, report all periods when vent

stream is diverted from control device through bypass line when on
waste;

(F) For CVS bypass lines without flow indicator, report periods which seal mechanism is broken, position has changed or key to unlock bypass line valve was checked out;

(G) Report each new operating scenari o that has been operated since last report; and

(H) SSM summary reports for the RTO control system, including associated CEMS and CMS equipment.

(2) In addition to the requirements described in D.14. (b)(1) of this condition, the Permittee shall report the following information for the SO 2, CO, and NOx CEMS to satisfy the PSD BACT requirements [326 IAC 2-1.1-11]:

(A) A list of days when condition D.14. 8 requires that CEMS data must be supplemented:

(B) A detailed report for each day when condition D.14.8 requires that CEMS data must be supplemented that provides:

(i) the information required by Condition D.14.4 (a)(3), and

(ii) an analysis of whether that information indicates continuous compliance with the limits established in Condition D.14.1 and if the NOx CEMS malfunctions for greater than six continuous hours, an assessment of NOx emissions, using process knowledge, whether the quantity of nitrogen fed into the RTO during that time could have exceeded the worst case 24-hourEli Lilly and Company-Tippecanoe Labs 4 th Significant Permit Modificati on No. 157-22717-00006 Page 138 of 226 Lafayette, Indiana Modified by: Aida De Guzman OP No. T157-6879-00006 Permit Reviewer: Dr. Trip Sinha

daily average nitrogen feed rate of 1,085 pounds per hour that
formed the basis of the NOx BACT limit.

(c) Immediate Reporting Requirements

The reporting requirements in the NESHAP G eneral Provisions for Startup, Shutdown and Malfunction (SSM) Plans [40 CFR 63.6(e)(3 )] shall be used to satisfy the reporting requirements under the Pharmaceutical MACT standards [40 CFR 63.1259(a)(3)], Offsite Waste MACT standards [40 CFR 63.697(b )(3)], and PSD BACT requirements [326 IAC 2-1.1-11].

(1) The Permittee shall report all acti ons taken during an RTO system SSM event

that results in an exceedance of a relevant emission standard when those actions are inconsistent with the proce dures specified in the SSM Plan. The immediate report shall be submitted to the agency via a telephone call or facsimile within 2 working days after commencing actions inconsistent with the plan.

(2) Within 7 working days after the end of an SSM event where an action taken by

the Permittee is not consistent with t he procedures specified in the SSM Plan, the Permittee shall submit a letter containing the following information in

accordance with 40 CFR 63.10(d)(5):

(A) Name, title and signature of respon sible official certifying accuracy;

(B) Explanation of the circ umstances of the event;

(C) Reason for not following the SSM Plan; and

(D) Report any excess emissions and/ or parameter monitoring exceedances

are believed to have occurred.

Modifications and Construction Requirements [326 IAC 2-7-10.5, 326 IAC 2-7-12 and 326 IAC 2-2]

D.14.11 Modifications and Construction: Advance approval of permit conditions

(a) The Permittee may modify any existing emissi on units listed in this section of the permit without obtaining a source modification appr oval (otherwise required by 326 IAC 2-7- 10.5), a Title V permit modification (otherwise required by 326 IAC 2-7-12), or a Prevention of Significant Deterioration permit (otherwise required by 326 IAC 2-2), provided the modified emission units are s ubject to the same applicable requirements listed in this D section, and the Permittee shall comply with the Change Management and Flexible Permit provisions in Section F.1 of this permit.

(b) The Permittee may construct and install new emission units comparable in function to the

emission units listed in this D section without obtaining a source modification approval (otherwise required by 326 IAC 2-7-10.5), a Title V permit modification (otherwise required by 326 IAC 2-7-12), or a Preven tion of Significant Deterioration permit (otherwise required by 326 IAC 2-2), provided the new emission units are subject to the same applicable requirements listed in this D section, and the Permittee shall comply with the Change Management and Flexible Permit provisions in Section F.1 of this permit.

The remainder of the page is left blank intentionally.Eli Lilly and Company-Tippecanoe Labs 4 th Significant Permit Modificati on No. 157-22717-00006 Page 139 of 226 Lafayette, Indiana Modified by: Aida De Guzman OP No. T157-6879-00006 Permit Reviewer: Dr. Trip Sinha

SECTION D.15 BPM CONTROL SYSTEMS – T 79 FUME INCINERATOR SYSTEM OPERATIONS

Facility Description [326 IAC 2-7-5(15)]

The information describing the proc esses contained in the following facility de scription is descriptive

information and does not constitute enforceable conditions:

(a) The following emissions units are subject to applicable requirements described in this D section:

Emission

Unit ID Emission Unit Description Stack/Vent Nominal Capacity Control

Device

T79-INC309 Fume Incinerator T79- INC309 7.6 MMBtu/hr Scrubber (313)

T79-INC310 Fume Incinerator T79- INC310 7.6 MMBtu/hr Scrubber (314)

(b) The following emission units are not subject to applicable requirements described in this D

section:

Emission

Unit ID Emission Unit Description Stack/Vent Nominal Capacity Control

Device

T79-COL304 Air Stripper Column T79 Inci nerator 4,400 gallons T79 Incinerator

T79-COL305 Air Stripper Column T79 Inci nerator 4,400 gallons T79 Incinerator

The T79 control system consists of two fume incinerators, identified as 309 and 310, each equipped with caustic scrubbing systems, and ea ch exhausting to individual stacks.

The closed vent system (CVS) associated with t he T79 control system begins at the outlet of the production building roof fans exhausting to the T79 fume transport system and at the outlet side

of the tank conservation vents of those tank modules exhausting to the T79 fume transport system and ends at the entranc e of the T79 control system.

Emission Limitations and Sta ndards [326 IAC 2-7-5(1)]

D.15.0 Requirement to Control Emissions [40 CFR 60 Subpart Kb, 40 CFR 63 Subpart GGG, 40 CFR 63 Subpart DD, 326 IAC 2-2- 3, and 326 IAC 8-5-3]
Except for equipment excluded from emission c ontrol requirements and except as otherwise provided by statute or rule, or in this permi t, the fumes from all emission units which reference this section shall be continuously routed to the T 79 control system while emission units vented to the control equipment are in operation. Except as otherwise provided by statute or rule, or in this permit, the T79 control system shall be operat ed at all times that the emission units vented to the control equipment are in operation.

D.15.1 T79 Control Device and Closed Vent Syst em Standards [40 CFR 63.1253(b), (c), and (d), 63.1254(a) and (c), 63.1256(b), (e), and (h), 63.1258(b), 40 CFR 63.685(c ) and (d), 63.689(b), 63.690(b), 63.693(f), 40 CFR 60.112b(a) and 60.11 3b(c), 326 IAC 2-2-3, and 326 IAC 8-5-3(b)]

(a) T79 Control Device Standards – The T79 control device standards shall apply at all times the unit is burning waste fume streams, exc ept as provided in Condition D.15.2 (a):

(1) VOC/VOHAP Emission Standards – In orde r to satisfy the Pharmaceutical MACT requirements [40 CFR 63.1253(b), (c), and (d), 63.1254(a) and (c), and 63.1256(b), (e) and (h), and 63.1258(b)], the Offsite Waste and Recovery Operations MACT requirements [40 CFR 63.685(c) and (d), 63.689(b), 63.690(b), and 63.693(f)], the PSD BAC T requirements [326 IAC 2-2-3], the Synthetic Pharmaceutical RACT requi rements [326 IAC 8-5-3(b)], and the New

Source Performance Standards for Vola tile Organic Liquid Storage Vessel requirements [40 CFR 60.112b(a) and 60. 113b(c)], the Permittee shall meet the following streamlined VOC/VOHAP emission standards:Eli Lilly and Company-Tippecanoe Labs 4 th Significant Permit Modificati on No. 157-22717-00006 Page 140 of 226 Lafayette, Indiana Modified by: Aida De Guzman OP No. T157-6879-00006 Permit Reviewer: Dr. Trip Sinha

(A) The VOC/VOHAP emissions shall be reduced by a control efficiency of 98% or more at the outlet of the T79 control system;

(B) The T79 combustion chamber shall maintain a minimum 24-hour daily average temperature established from a compliant stack test.

(2) Hydrogen halide and halogen Emission Standards – In order to satisfy the Pharmaceutical MACT requirements [40 CFR 63.1253(b), (c), and (d), 63.1254(a) and (c), 63.1256(b), (e) and (h), and 63.1258(b)] and PSD BACT requirements for fluorides [326 IAC 2-2-3], the Permittee shall meet the following streamlined hydrogen halide and halogen (including hydrogen fluoride) emission

standards:

(A) The HCl/Cl 2 emissions shall be reduced by a control efficiency of 98% or more at the outlet of the T79 system; and

(B) The T79 caustic scrubber system shall maintain the following parametric conditions established from a compliant stack test:

(i) Minimum 24-hour daily average scrubber liquid pH;

(ii) Minimum 24-hour daily average scrubber liquid recirculation flow rate; and

(iii) Maximum 24-hour daily averag e scrubber caustic flow rate.

(b) T79 Closed Vent System Inspection Standards – The following inspection standards shall apply to the T79 CVS, except as pr ovided in Condition D.15.2 (b):

(1) The Permittee shall comply with the following CVS inspection requirements to satisfy the Pharmaceutical MACT requi rements [40 CFR 63.1256(b)(3) and (e)(1) and 63.1258(h)], the Offsite Waste MA CT requirements [40 CFR 63.685(g), 63.689(b), 63.690(b), 63.693(b) and (c), and 63.695(c)], and the PSD BACT requirements [326 IAC 2-2-3]:

(A) Conduct an initial one-time Method 21 inspection on new portions of the T79 CVS not operated under negative pressure and not subject to LDAR within 150 days after startup. Portions of the T79 CVS that are operated under negative pressure shall be equipped with a pressure gauge or other pressure measurement/detection. The data output from the must be viewable from a readily accessibl e location to verify that negative pressure is being maintained when waste fume streams are going to the control system.

(B) Perform annual visual inspections of the T79 CVS for visible cracks, holes or gaps, loose connections, and broken or missing caps.

(C) Initiate repair of any leak detected on the T79 CVS no later than 5 calendar days after identification, and complete the repair within 15 days after identification, unless:

(i) The repair is technically infeasible without a shutdown of an operation or process; or

(ii) It is determined that emissions resulting from immediate repair would be greater than the fugitive emissions likely to result from delay of repair.Eli Lilly and Company-Tippecanoe Labs 4 th Significant Permit Modificati on No. 157-22717-00006 Page 141 of 226 Lafayette, Indiana Modified by: Aida De Guzman OP No. T157-6879-00006 Permit Reviewer: Dr. Trip Sinha

Repairs delayed due to either of the ca uses described in (A) or (B) shall be completed by the end of the next shutdown.

(2) The Permittee shall monitor each bypass line on the T79 CVS to satisfy the Pharmaceutical MACT requirements [40 CFR 63.1252(b), 63.1253(b) and (c), and 63.1258(b)], the Offsite Waste MA CT requirements [40 CFR 63.685(g), 63.689(b), 63.690(b), and 63.693(c)], and the PSD BACT requirements [326 IAC 2-2-3] using one of the following methods:

(A) Install and monitor the position of the T79 CVS bypass valve at least once every 15 minutes, where the closed position means there is no bypass flow; or

(B) Secure the bypass line valve in the closed position with a car seal or lock and key type configuration. Monthly vis ual inspections of seal or locking device shall be performed to ensure the s eal is not broken or the valve is in the closed position and the vent st ream is not diverted through the bypass line.

D.15.2 Exceptions to T79 Control System St andards [40 CFR 63.1260(g), 40 CFR 63.6(e)(3) and 63.8(c), and 40 CFR 63.681, 63.685(g ), 63.693(b) and 326 IAC 2-2-3]

(a) Exceptions to T79 Control Device Operational Standards – The following streamlined standards satisfy the Pharmaceutical MACT standards [40 CFR 63.1260(g)], Offsite Waste MACT standards [40 CFR 63.681, 63.685(g) and 63.693(b)], and PSD BACT requirements [326 IAC 2-2-3]:

(1) The Permittee may open a safety device and bypass the T79 system at any time conditions require it to do so to avoid unsafe conditions.

(2) The provisions of Conditions D.15.1 (a ) shall not apply during periods of startup, shutdown or malfunction that preclude the Permittee from complying with Condition D.15.1 (a), provided the Permi ttee complies with the provisions of the startup, shutdown, and malfunction pl an (SSM Plan) required by Condition

D.15.3.

(b) Exceptions to T79 CVS Inspection Standards – The following streamlined standards satisfy the Pharmaceutical MACT standards [40 CFR 63.1258(h)(6) and (7)], and PSD BACT requirements [326 IAC 2-2-3]:

(1) The Permittee is not required to insp ect if unsafe or difficult to inspect.

D.15.3 Startup, Shutdown, and Malfunction Requirements for T79 Control System [40 CFR 63.1259(a)(3), 40 CFR 63.697(b)(3), 40 CFR 63.6 (e)(3), 40 CFR 63.8(c) and 326 IAC 2-2-3]

(a) The NESHAP General Provisions for Star tup, Shutdown and Malfunction (SSM) Plans [40 CFR 63.6(e)(3)] shall be used to sati sfy the Pharmaceutical MACT standards [40 CFR 63.1259(a)(3)], Offsite Waste MACT standards [40 CFR 63.697(b)(3)], and PSD BACT requirements [326 IAC 2-2.1.11].

(b) Pursuant to 40 CFR 63.6(e)(3), the Permi ttee shall develop an SSM Plan to ensure that the T79 fume incinerator control syst em, including associated CEMS and CMS equipment, is operated and maintained in a manner which satisfies the general duty to minimize emissions established by 40 CFR 63.6(e)(1)(i), and that all malfunctions are corrected as soon as practicable after thei r occurrence in order to minimize excess emissions. The SSM Plan shall contain the following information:Eli Lilly and Company-Tippecanoe Labs 4 th Significant Permit Modificati on No. 157-22717-00006 Page 142 of 226 Lafayette, Indiana Modified by: Aida De Guzman OP No. T157-6879-00006 Permit Reviewer: Dr. Trip Sinha

(1) Detailed procedures for operating and maintaining the T79 system, including associated CEMS and CMS equipment, during periods of startup, shutdown, and malfunction; and

(2) Corrective action program for malfunctioning air pollution control equipment.

Compliance Determination Requirements

D.15.4 Requirement to Control Emissions [40 CFR 60 Subpart Kb, 40 CFR 63 Subpart GGG, 40 CFR 63 Subpart DD, 326 IAC 2-2- 3, and 326 IAC 8-5-3]

Except for equipment excluded from emission c ontrol requirements and except as otherwise provided by statute or rule or in this permit, the T79 control system shall be operated at all times that the emission units vented to the control equipment are in operation.

Testing and Monitoring Requirements [326 IAC 2-7-6(1) (6)] [326 IAC 2-7-5(1)]

D.15.5 Performance Testing Requirements [40 CFR 60.113b(c), 40 CFR 63.7, 40 CFR 63.1257(b), (c), and (d) and 63.1258(b)(3), 40 CFR 63.693(f), 326 IAC 3-6-3(c), and 326 IAC 2-1.1-11]

(a) Initial Comprehensive Performance Test Requirements:

(1) VOC/VOHAP Performance Test Requirements – The following streamlined requirements satisfy the Pharmaceutical MACT standards [40 CFR 63.1257(b), (c), and (d) and 63.1258(b)], Offsite Wast e MACT standards [40 CFR 63.693(f)], Volatile Organic Liquid Storage Vessel requirements [40 CFR 60.113b(c)], PSD BACT requirements [326 IAC 2-1.1-11], and emission testing requirements for MACT sources [326 IAC 3-6-3(c)]:

(A) The Permittee shall conduct an initial performance test in accordance
with the methods set forth in 40 CFR 63.1257.

(B) The Permittee shall submit a notification of the performance test and a site-specific test plan at least 60 days in advance of the intended performance test date.

(C) The operating parameters defined in Condition D.15.1 (a)(1) shall be monitored during the performance test to establish the 24-hour daily average parametric limits, accordi ng to the requirements of 40 CFR 63.1258(b)(3).

(D) The Permittee shall submit the performance test reports, and upon request, the CMS performance evaluation, within 45 days following the test. The Permittee is allowed an extension of 15 days if a reasonable explanation is provided within 40 days following the test.

(2) Hydrogen Chloride Performance Test Requirements – The following requirements satisfy the Pharmaceutical MACT standards [40 CFR 63.1258(b)] and the PSD BACT requirements for fluorides [326 IAC 2-1.1-11]:

(A) The Permittee shall conduct a performance test to determine the hydrogen halides and halogens cont rol efficiency standard, which includes fluorides, and conduct an initial performance test in accordance
with the methods set forth in 40 CFR 63.1257.

(B) The Permittee shall submit a notification of the performance test and a site-specific test plan at least 60 days in advance of the intended performance test date.Eli Lilly and Company-Tippecanoe Labs 4 th Significant Permit Modificati on No. 157-22717-00006 Page 143 of 226 Lafayette, Indiana Modified by: Aida De Guzman OP No. T157-6879-00006 Permit Reviewer: Dr. Trip Sinha

(C) The operating parameters defined in Condition D.15.1 (a)(2) shall be monitored during the performance test to establish the 24-hour daily average parametric limits, accordi ng to the requirements of 40 CFR 63.1258(b)(3).

(D) The Permittee shall submit the performance test reports, and upon request, the CMS performance evaluation, within 45 days following the test. The Permittee is allowed an extension of 15 days if a reasonable explanation is provided within 40 days following the test.

(b) Subsequent Comprehensive Performance Test Requirements:

The Permittee shall repeat the perform ance tests for VOC/VOHAP and Hydrogen Halide/Halogens at least once every five y ears from the date of the most recent valid compliance demonstration.

D.15.6 Parametric Continuous Monitoring System (CMS) Requirements [40 CFR 63.8(c), 40 CFR 60.113b(c), 40 CFR 63.1257(b), 63.1258(a) and (b ), and 63.1260(e), 40 CFR 63.693(b), 326 IAC 2-1.1-11, and 326 IAC 3-5-5(d)]

(a) VOC/VOHAP CMS Requirements - The fo llowing streamlined requirements apply only when burning waste fume streams to satisf y the Pharmaceutical MACT standards [40 CFR 63.1258(a) and (b)], Offsite Waste MACT standards [40 CFR 63.684(e)(1)], Volatile Organic Liquid Storage Vessel requirements [40 CFR 60.113b(c)], and PSD BACT requirements [326 IAC 2-1.1-11]:

(1) T79 Combustion Chamber Temperature – The Permittee shall install and operate the T79 combustion chamber temperature CMS in accordance with 40 CFR 63.8(c).

(2) Continuous operation is defined as the collection of at least one measurement for each successive 15-minute period.

(b) Hydrogen Halide/Halogen and Fluorides CMS Requirements – The following requirements apply only when burning waste fume streams to satisfy the Pharmaceutical MACT standards for hydrogen halides a nd halogens [40 CFR 63.1257(b), 63.1258(b), and 63.1260(e)] and the PSD BACT requirement s for fluorides [326 IAC 2-1.1-11]:

(1) The Permittee shall install and operate the following CMSs in accordance with 40 CFR 63.8(c):

(A) Scrubber liquid pH monitor;

(B) Scrubber liquid recirculation flow rate monitor; and

(C) Scrubber caustic flow rate monitor.

(2) Continuous operation is defined as the collection of at least one measurement for each successive 15-minute period.

(c) CMS Quality Control Program – The Permittee shall prepare and implement a quality control program for the CMS units in accordance with 40 CFR 63.8(d).

D.15.7 Excursions [40 CFR 63.1258(b)(6)]

(a) Pursuant to the Pharmaceutical MACT stand ards [40 CFR 63.1258(b)(7)] and the Offsite Waste MACT [40 CFR 63.695(e)(4)], and to satisfy the monitoring for the BACTEli Lilly and Company-Tippecanoe Labs 4 th Significant Permit Modificati on No. 157-22717-00006 Page 144 of 226 Lafayette, Indiana Modified by: Aida De Guzman OP No. T157-6879-00006 Permit Reviewer: Dr. Trip Sinha

requirement [326 IAC 2-1.1-11], excursions are defined as follows and apply to the CEMS and CMS required by Condition D.15.5:

(1) When the period of control device operat ion (i.e., receiving waste fume streams) is 4 hours or greater in an operating day and monitoring data are insufficient to

constitute a valid hour of data for at least 75 percent of the operating hours.

(2) When the period of control device operat ion (i.e., receiving waste fume streams) is less than 4 hours in an operating day and more than one of the hours during the period of operation does not constitute a valid hour of data due to insufficient monitoring data.

(b) A valid hour requires at least one data point for each 15-minute period in the operating

hour.

Record Keeping and Reporting Requiremen t [326 IAC 2-7-5(3)] [326 IAC 2-7-19]

D.15.8 Record Keeping and Reporting Requirements

(a) Record Keeping Requirements

The Permittee shall maintain the following records:

(1) Control Device (T79) Records – The Pharmaceutical MACT record keeping requirements [40 CFR 63.1259] shall serv e as the streamlined requirement that
satisfies the Offsite Waste MACT sta ndards [40 CFR 63.696], Volatile Organic Liquid Storage Vessel requirements [40 CFR 60.115b], PSD BACT requirements [326 IAC 2-1.1-11], and continuous emission monitoring and performance testing requirements [326 IAC 3-5 and 3-6]:

(A) Records of the current and superseded versions of SSM Plan;

(B) Description of worst-case operating conditions;

(C) Results of control device perf ormance tests and CMS performance evaluations;

(D) Records of all required CMS data;

(E) Records of each CMS calibration checks;

(F) Maintenance records for each control device and CMSs;

(G) Occurrence/duration records of ea ch control device malfunction and CMS malfunction;

(H) Information to demonstrate conformance with each SSM are consistent with procedures in the SSM Plan;

(I) Records of actions taken during each SSM when different from SSM Plan; and

(J) Record of the current standard operating procedure (SOP) for the T79

CMS units.

(2) Closed Vent System (T79 CVS) Record s – The Pharmaceutical MACT record keeping requirements [40 CFR 63.12 59] shall serve as the streamlined requirement that satisfies the Offsite Waste MACT standards [40 CFR 63.696],Eli Lilly and Company-Tippecanoe Labs 4 th Significant Permit Modificati on No. 157-22717-00006 Page 145 of 226 Lafayette, Indiana Modified by: Aida De Guzman OP No. T157-6879-00006 Permit Reviewer: Dr. Trip Sinha

Volatile Organic Liquid Storage Vessel requirements [40 CFR 60.115b], PSD BACT requirements [326 IAC 2-1.1-11], and continuous emission monitoring and performance testing requirements [326 IAC 3-5 and 3-6]:

(A) Hourly records of bypass flow indi cator operating status and the time and

duration of all diversions detected by the bypass flow indicator, if complying via this method;

(B) Monthly visual inspection reco rds of bypass line valves and the occurrence of all periods the valve position has changed, if complying via this method;

(C) For each portion of the CVS not operated under negative pressure, record each component that is unsafe to inspect, and a plan for inspecting the component as frequent ly as practicable during safe-toinspect times;

(D) For each portion of the CVS not operated under negative pressure, record each component that is difficult to inspect and a written plan for inspecting the component at least once every five years;

(E) For each part of the CVS not oper ated under negative pressure, record the following information if no leaks are detected during the initial Method 21 inspection or annual visual inspections:

(i) Date each inspection was performed; and

(ii) Statement for each inspecti on that no leaks were detected.

(F) For each part of the CVS not operated under negative pressure, record the following information for all leaks detected during the initial Method 21 inspection:

(i) Identification of leaking equipment;

(ii) Instrument ID and operator name or initials;

(iii) Date the leak was detected and date of first attempt to repair leak;

(iv) Maximum instrument reading after leak from initial Method 21 is successfully repaired or de clared non-repairable; and

(v) Record of reason for any del ay of repair, name of person responsible for decision, expect ed date of repair, dates of shutdowns when repair is made and date of successful repair of

leak.

(G) For each part of the CVS not operated under negative pressure, record the following information for all l eaks detected from the annual visual inspection:

(i) Identification of leaking equipment;

(ii) Date leak was detected and first attempt to repair leak; and

(iii) Record of reason for any delay of repair, name of person responsible for decision, expect ed date of repair, dates ofEli Lilly and Company-Tippecanoe Labs 4 th Significant Permit Modificati on No. 157-22717-00006 Page 146 of 226 Lafayette, Indiana Modified by: Aida De Guzman OP No. T157-6879-00006 Permit Reviewer: Dr. Trip Sinha

shutdowns when repair is made and date of successful repair of

leak.

(b) Quarterly Periodic Reporting Requirements

(1) The following Pharmaceutical MA CT reporting requirements [40 CFR 63.1260(g)], which references the MACT General Provisions [40 CFR 63.7 – 63.10], shall serve as the streamlined r eporting requirements that satisfy the Offsite Waste MACT standards [40 CFR 63.697], Volatile Organic Liquid Storage Vessel requirements [40 CFR 60.115b ], PSD BACT requirements [326 IAC 2- 1.1-11], and continuous emission moni toring requirements [326 IAC 3-5]:

(A) Reports shall be submitted within 30 days following the reporting period using the reporting forms located at the end of this permit, or their equivalent;

(B) If total duration of excess emi ssions, parameter exceedances, or excursions is 1% or greater of total operating time or total CMS downtime is greater than 5% for reporting period, include:

(i) 15-minute data and daily averages for all operating days out of

range;

(ii) duration of excursions; and

(iii) operating logs and scenarios fo r all operating days out of range;

(C) Summary reports of excess emis sions, parameter exceedances, and monitor downtime including informati on specified in 63.10(c)(5)-(c)(13);

(D) Report, when applicable, no exce ss emissions, no exceedances, no excursions, and no CMS have been inoperative, out of control, repaired or adjusted;

(E) CVS bypass lines with flow indicator: report all periods when vent stream is diverted from control device through bypass line;

(F) CVS with bypass lines without flow indicator: report periods which seal mechanism is broken, position has changed or key to unlock bypass line valve was checked out;

(G) Report each new operating scenari o that has been operated since last report;

(H) SSM summary reports for the T79 control system, including associated CEMS and CMS equipment.

(c) Immediate Reporting Requirements

The reporting requirements in the NESHAP G eneral Provisions for Startup, Shutdown and Malfunction (SSM) Plans [40 CFR 63.6(e)(3 )] shall be used to satisfy the reporting requirements under the Pharmaceutical MACT standards [40 CFR 63.1259(a)(3)], Offsite Waste MACT standards [40 CFR 63.697(b )(3)], and PSD BACT requirements [326 IAC 2-1.1-11].

(1) The Permittee shall report all actions taken during a T79 system SSM event that

results in an exceedance of a relevant emission standard when those actions are inconsistent with the procedures specif ied in the SSM Plan. The immediateEli Lilly and Company-Tippecanoe Labs 4 th Significant Permit Modificati on No. 157-22717-00006 Page 147 of 226 Lafayette, Indiana Modified by: Aida De Guzman OP No. T157-6879-00006 Permit Reviewer: Dr. Trip Sinha

report shall be submitted to the agency via a telephone call or facsimile within 2 working days after commencing actions inconsistent with the plan.

(2) Within 7 working days after the end of an SSM event where an action taken by

the Permittee is not consistent with t he procedures specified in the SSM Plan, the Permittee shall submit a letter containing the following information in

accordance with 40 CFR 63.10(d)(5):

(A) Name, title and signature of respon sible official certifying accuracy;

(B) Explanation of the circ umstances for the event;

(C) Reason for not following the SSM Plan; and

(D) Report any excess emissions and/ or parameter monitoring exceedances

are believed to have occurred.

Modifications and Construction Requirements [326 IAC 2-7-10.5, 326 IAC 2-7-12 and 326 IAC 2-2]

D.15.9 Modifications and Construction: Ad vance approval of permit conditions

(a) The Permittee may modify any existing emissi on units listed in this section of the permit without obtaining a source modification appr oval (otherwise required by 326 IAC 2-7- 10.5), a Title V permit modification (otherwise required by 326 IAC 2-7-12), or a Prevention of Significant Deterioration permit (otherwise required by 326 IAC 2-2), provided the modified emission units are s ubject to the same applicable requirements listed in this D section, and the Permittee shall comply with the Change Management and Flexible Permit provisions in Section F.1 of this permit.

(b) The Permittee may construct and install new emission units comparable in function to the

emission units listed in this D section without obtaining a source modification approval (otherwise required by 326 IAC 2-7-10.5), a Title V permit modification (otherwise required by 326 IAC 2-7-12), or a Preven tion of Significant Deterioration permit (otherwise required by 326 IAC 2-2), provided the new emission units are subject to the same applicable requirements listed in this D section, and the Permittee shall comply with the Change Management and Flexible Permit provisions in Section F.1 of this permit.

The remainder of the page is left blank intentionally.Eli Lilly and Company-Tippecanoe Labs 4 th Significant Permit Modificati on No. 157-22717-00006 Page 148 of 226 Lafayette, Indiana Modified by: Aida De Guzman OP No. T157-6879-00006 Permit Reviewer: Dr. Trip Sinha

SECTION D.16 BPM SUPPORT OPERATIONS – RESEARCH AND DEVELOPMENT OPERATIONS

Facility Description [326 IAC 2-7-5(15)]

The information describing the proc esses contained in t he facility description boxes is descriptive

information and does not constitute enforceable conditions:

(a) The emission units listed below are insignificant activities as defined in 326 IAC 2-7-1(21), but are subject to applicable requirements descri bed or referred to in this D section.

Emission

Unit ID Emission Unit Description Stack/Vent Nominal Capacity Control

Device

Building T71:

31A985DUCHT4 Charge Tank Atmosphere 10 gal None

TI0031000MS001 Slurry Mill Atmosphere NA None

T46109 Slurry Mill Atmosphere NA None
T69126 Centrifuge Atmosphere 5 liters None

T63150 Plate Filter Atmosphere 0.15 m 3 None

T44224 Filter Dryer Atmosphere NA None

T71-TK5700 Waste Tank Atmosphere 1000 gallons None

T71-TK9601 Portable Process Tank Atmosphere 50 gallons None

T71-TK9602 Portable Process Tank Atmosphere 50 gallons None

T71-TK9605 Portable Process Tank Atmosphere 30 gallons None

T71-TK9606 Portable Process Tank Atmosphere 50 gallons None

T71-TK9609 Portable Process Tank Atmosphere 30 gallons None

T71-TK9610 Portable Process Tank Atmosphere 50 gallons None

T71-TK9611 Portable Process Tank Atmosphere 50 gallons None

T71-TK9612 Portable Process Tank Atmosphere 50 gallons None
T71-TK9613 Condensate Collection Tank Atmosphere 10 gallons None

T71-TK9614 Condensate Collection Tank Atmosphere 10 gallons None

T71-TK9615 Condensate Collection Tank Atmosphere 10 gallons None

T71-TK9616 Condensate Collection Tank Atmosphere 10 gallons None

T71-TK9617 Condensate Collection Tank Atmosphere 20 gallons None

T71-TK9623 Charge Tank Atmosphere 10 gallons None

T71-TK9624 Charge Tank Atmosphere 10 gallons None

T71-TK9625 Charge Tank Atmosphere 10 gallons None

T71-TK9626 Charge Tank Atmosphere 10 gallons None

T71-RVD9801 Rotary Vacuum Dryer Atmosphere 3 cubic feet None
T71-FLT9901 Single-Plate Filter Atmosphere N/A None

T71-FLT9902 Multi-Plate F ilter Atmosphere N/A None

Emission Limitations and Sta ndards [326 IAC 2-7-5(1)]

D.16.1 Non-Applicability Determination [ 40 CFR 63, Subpart GGG and 326 IAC 8-5-3]

(a) The emission units listed above are not subject to the requirements of 40 CFR 63, Subpart GGG (Pharmaceutical MACT Standards) because these operations are research and development facilities that are exempt pursuant to 40 CFR 63.1250(d) and 63.1251.

(b) The emission units listed above are not subject to the requirements of 326 IAC 8-5-3 because the potential to emit VOC of any fa cility is less than 15 pounds per day.Eli Lilly and Company-Tippecanoe Labs 4 th Significant Permit Modificati on No. 157-22717-00006 Page 149 of 226 Lafayette, Indiana Modified by: Aida De Guzman OP No. T157-6879-00006 Permit Reviewer: Dr. Trip Sinha

D.16.2 Reserved

D.16.3 Leak Detection and Repair (LDAR) for Fugitive Emissions [CP157-4148 (Revised by this permit)]

The LDAR standards that apply to components associated with the process operations in Building T71are described in Section E.1 of this permit and the waste tank in T71 are described in Section E.2 of this permit.

Record Keeping and Reporting Requirements [326 IAC 2-7-5(3) and 326 IAC 2-7-19]

D.16.4 Reserved

Modifications and Construction Requirements [326 IAC 2-7-10.5, 326 IAC 2-7-12 and 326 IAC 2-2]

D.16.5 Modifications and Construction: Advance A pproval of Permit Conditions Requirements

The emission units described in this D section are not subject to the advance approval permit

conditions.

The remainder of the page is left blank intentionally.Eli Lilly and Company-Tippecanoe Labs 4 th Significant Permit Modificati on No. 157-22717-00006 Page 150 of 226 Lafayette, Indiana Modified by: Aida De Guzman OP No. T157-6879-00006 Permit Reviewer: Dr. Trip Sinha

SECTION D.17 BPM SUPPORT OPERATIONS – GENERAL WASTEWATER CONDITIONS

Facility Description [326 IAC 2-7-5(15)]

The information describing the pr ocesses contained in the following facility description boxes is descriptive information and does not constitute enforceable conditions.

(a) BPM Wastewater Operations – The emissi on units associated with the BPM wastewater operations can generally be described as storage and transfer facilities (wastewater tanks, containers and individual drain systems) and treatme nt facilities (chemical wastewater treatment plant, incineration, or offsite treatment). The specific emission units are described in Sections D.8, D.10, D.11, D.12, D.13, D. 18 and D.19 of this permit.

(b) Fermented Products Wastewater Operations – The emission units associated with the fermented products wastewater operations can generally be described as storage and transfer facilities (biosolids tanks) and treatment facilities (biologi cal wastewater treatment plant. The specific
emission units are described in Section D.5 of this permit. The wastewater operations associated with fermented products are not subject to the storage, transfer and treatment requirements of this section of the permit because the wastewat er does not meet the definition of an affected

wastewater.

Emission Limitations and St andards [326 IAC 2-7-5(1)]

D.17.1 Definition of Wastewater [40 CFR 63.1251 and 40 CFR 63.1256(a)(1)(i)]

(a) Wastewater in this section of the permit is defined as any water that is discarded from a pharmaceutical manufacturing process unit th rough a single point of determination (POD) that contains an annual average concentrati on of partially soluble and/or soluble HAP compounds of at least 5 parts per million by weight and a load of at least 0.05 kg/yr. Wastewater does not include the following:

(1) Stormwater from segregated sewers;

(2) Water from fire-fighting and deluge system s, including testing of such systems;

(3) Spills;

(4) Water from safety showers;

(5) Samples of a size not greater than reasonably necessary for the method of analysis that is used;

(6) Equipment leaks;

(7) Wastewater drips from procedures such as disconnecting hoses after clearing lines;

(8) Noncontact cooling water; and

(9) Primary waste (waste with a net positive heating value).

(b) Point of determination (POD) is defined as t he point where a wastewater stream exits the process, storage tank, or last recovery dev ice. If soluble and/or partially soluble HAP compounds are not recovered from water befor e discharge, the discharge point from the process equipment or storage tank is a POD. If water streams are routed to a recovery device, the discharge from the recovery dev ice is a POD. There can be more than one POD per process or pharmaceutical ma nufacturing process unit. [40 CFR 63.1251]Eli Lilly and Company-Tippecanoe Labs 4 th Significant Permit Modificati on No. 157-22717-00006 Page 151 of 226 Lafayette, Indiana Modified by: Aida De Guzman OP No. T157-6879-00006 Permit Reviewer: Dr. Trip Sinha

(c) Affected wastewater is defined as follows:

(1) Any wastewater stream containing part ially soluble HAP compounds at an annual average concentration greater than 1300 ppmw, and the total soluble and partially soluble HAP load in all wastewat er from the PMPU exceeds 0.25 Mg/yr; or [40 CFR 63.1256(a)(1)(i)(A)]

(2) Any wastewater stream containing partially soluble and/or soluble HAP compounds at an annual average concentration greater than 5200 ppmw, and the total soluble and partially soluble HAP load in all wastewater from the PMPU exceeds 0.25 Mg/yr. [40 CFR 63.1256(a)(1)(i)(B)]

Maintenance wastewater is not consid ered an affected wastewater stream.

D.17.2 Maintenance Wastewater [40 CFR 63.1256(a)(4)(iii)]

The Permittee shall prepare a maintenance wastew ater plan and implement this plan as part of the Startup, Shutdown, and Malfunction (SSM) Plan for maintenance wastewater as required under 40 CFR 63.6(e)(3). [ 40 CFR 63.1256(a)(4)(iii)]

D.17.3 Storage and Transfer of Affected Wast ewater [40 CFR 63.1256(b), (d), and (e)]

(a) The following emission units are used to store or transfer affected wastewater from the BPM operations:

(1) BPM Containers – The emission units and performance standards are described in Section D.11 of this permit.

(2) BPM Individual Drain Systems – These emission units and performance standards for the individual drain system s are described in Section D.8 of this permit.

(3) Affected Wastewater Tanks – These emission units and performance standards are streamlined with the requirements fo r BPM waste tanks described in Section D.10 of this permit.

(b) The emission units in the fermented products operations do not store or transfer affected

wastewater.

D.17.4 Treatment of Affected Wastewater [40 CFR 63.1256]

Pursuant to the Pharmaceutical MACT r equirements under 40 CFR 63.1256, the affected

wastewater and residuals shall be treated us ing the following methods as applicable:

(a) Enhanced biological treatment system – The equipment and performance standards for the treatment of affected wastewater using the enhanced biological treatment system are described in Section D.18 of this permit.

(b) Waste incineration – The equipment and performance standards for the thermal destruction of the affected wastewater by in cineration are described in Sections D.12 and D.13 of this permit.

(c) Transfer of affected wastewater stream s for offsite treatment – The performance standards for offsite disposal of affected wastew ater are described in Section D.19 of this permit.Eli Lilly and Company-Tippecanoe Labs 4 th Significant Permit Modificati on No. 157-22717-00006 Page 152 of 226 Lafayette, Indiana Modified by: Aida De Guzman OP No. T157-6879-00006 Permit Reviewer: Dr. Trip Sinha

Testing and Monitoring Requirements [326 IAC 2-7-6(1) (6)] [326 IAC 2-7-5(1)]

D.17.5 Testing and Monitoring Requirements

The requirements for the storage, transfer and treatment of the affected wastewater are described in Sections D.8, D.10, D.11, D.12, D.13, D.18 and D.19 of this permit.

Record Keeping and Reporting Requirements

D.17.6 Record keeping and Reporting Requirements

(a) The following record keeping and reporting requirements apply to the maintenance wastewater plan required under 40 CFR 63.1256(a)(4)(iv) and 63.6(e)(3):

(1) Maintain record of original maint enance wastewater plan for the life of the

affected source or until the affected source is no longer subject to the provisions of this rule;

(2) Maintain updated versions of the main tenance wastewater plan, as necessary;

(3) Maintain records for each instance the plan was implemented and whether the plan was followed; and

(4) Record and report all instances within 2 working days after commencing actions inconsistent with the SSM plan followed by a written letter within 7 working days

after the end of the event.

(b) Each POD as defined in Condition D.17.1 (b ) shall be identified and its wastewater HAP

concentration documented in the On-Site Im plementation Log (OSIL) as required by 40 CFR 63.1259(b)(6) and 40 CFR 63. 1251 – Operating Scenario.

The remainder of the page is left blank intentionally.Eli Lilly and Company-Tippecanoe Labs 4 th Significant Permit Modificati on No. 157-22717-00006 Page 153 of 226 Lafayette, Indiana Modified by: Aida De Guzman OP No. T157-6879-00006 Permit Reviewer: Dr. Trip Sinha

SECTION D.18 BPM SUPPORT OPERATIONS – CHEMICAL WASTEWATER TREATMENT PLANT

CONDITIONS

Facility Description [326 IAC 2-7-5(15)]

The information describing the pr ocesses contained in the following facility description boxes is descriptive information and does not constitute enforceable conditions:

(a) The following emission units are subject to applicable requirements described or referred to in this D section. These emission units represent the enhanced biological treatment system.

Emission

Unit ID Emission Unit Description Stack/Vent Nominal Capacity Control

Device

BPM Wastewater Treat ment Plant (WWTP):

T78-TK511 Activated Sludge Tank Atmosphere 8 million gallons N/A

T78-TK512 Activated Sludge Tank Atmosphere 8 million gallons N/A

(b) The following emission units of the wastewater treatment system are not subject to applicable requirements described in this D section.

Emission

Unit ID Emission Unit Description Stack/Vent Nominal Capacity Control

Device

BPM Wastewater Treat ment Plant (WWTP):

T78-TK520A* Clarifier Atmos phere 1.4 million gallons N/A

T78-TK520B* Clarifier Atmos phere 1.4 million gallons N/A

T78-TK520C* Clarifier Atmosphere 1.4 million gallons N/A

T78-TK522* Thickener Atmos phere 1.4 million gallons N/A

T78-TK550* Emergency Diversion T ank Atmosphere 900,000 gallons N/A

T78-TK551* Sludge Collection Tank Atmosphere 700,000 gallons N/A

TK525* Sludge Tank Atmosphere 193,000 gallons N/A

TK526* Sludge Tank Atmosphere 193,000 gallons N/A

* Emission units marked with an asterisk are insignific ant activities as defined by 326 IAC 2-7-1(21)(A)-(C) and 326 IAC 2-7-1(21)(G)(ix)(AA).

Emission Limitations and Sta ndards [326 IAC 2-7-5(1)]

D.18.1 Pharmaceutical MACT Standards [40 CFR 63.1256]

(a) Pursuant to the Pharmaceutical MA CT standards for wastewater [40 CFR 63.1256(g)(10)], the Permittee may use t he enhanced biological treatment system (activated sludge tank T78-TK511 or T78-TK512) to treat affected wastewater streams, defined in Section D.17 of this permit, except:

(1) Mixed (soluble and partially soluble HAP) wastewater streams greater than 5200 ppmw, where the partially soluble HAP component is equal to or greater than 50

ppmw; or

(2) Wastewater streams containing combi ned partially soluble HAPs greater than 1300 ppmw.Eli Lilly and Company-Tippecanoe Labs 4 th Significant Permit Modificati on No. 157-22717-00006 Page 154 of 226 Lafayette, Indiana Modified by: Aida De Guzman OP No. T157-6879-00006 Permit Reviewer: Dr. Trip Sinha

(b) Pursuant to the Pharmaceutical MACT st andards for wastewater [40 CFR 63.1251 and 40 CFR 63.1256(g)(10)], the Permittee shall ma intain a minimum mixed liquor volatile suspended solids (biomass) concentration of 1 kg/cubic meter (942 mg/l) of the mixed liquor in the enhanced biological treatment system.

Testing and Monitoring Requirements [326 IAC 2-7-6(1) (6)] [326 IAC 2-7-5(1)]

D.18.2 Sampling and Analysis Requirements [40 CFR 63.1258(g)(2)]

Pursuant to the Pharmaceutical MACT standards [40 CFR 63.1258(g)(2)], the Permittee shall measure the following parameters for each enhanced biological treatment unit in use at least once per week and record the weekly average data:

(a) Total suspended solids (TSS), chemical oxygen demand (COD); and

(b) Biomass (VSS) concentration.

Recordkeeping and Reporting Requirement s [326 IAC 2-7-5(3)] [326 IAC 2-7-19]

D.18.3 Record Keeping and Reporting Requirements

(a) The Permittee shall maintain the sampling and analysis records required by Condition

D.18.2 in accordance with the Pharmaceutic al MACT record keeping requirements [40 CFR 63.1259(b)(1)].

Modifications and Construction Requirements [326 IAC 2-7-10.5, 326 IAC 2-7-12 and 326 IAC 2-2]

D.18.4 Modifications and Construction: Advance A pproval of Permit Conditions Requirements

The emission units described in this D section are not subject to the advance approval permit

conditions.

The remainder of the page is left blank intentionally.Eli Lilly and Company-Tippecanoe Labs 4 th Significant Permit Modificati on No. 157-22717-00006 Page 155 of 226 Lafayette, Indiana Modified by: Aida De Guzman OP No. T157-6879-00006 Permit Reviewer: Dr. Trip Sinha

SECTION D.19 BPM SUPPORT OPERATIONS – TRANSFER OF AFFECTED WASTEWATER FOR

OFFSITE TREATMENT CONDITIONS

Facility Description [326 IAC 2-7-5(15)]

The information in this facility description section doe s not constitute enforceable conditions. The transfer

of affected wastewater for offsite treatment re lates to either of the following situations:

(a) Shipment of affected wastewater generated on site to an offsite trea tment facility; or

(b) Receipt of an offsite affected wastewater to be treated onsite.

Emission Limitations and Sta ndards [326 IAC 2-7-5(1)]

D.19.1 Shipment of Affected Wastewater to an O ffsite Treatment Facility [40 CFR 63.1256(a)(5)]

(a) Pursuant to the Pharmaceutical MA CT standards for wastewater [40 CFR 63.1256(a)(5)(i)(B)], the Permittee shall include a notice with each shipment of affected

wastewater or resi dual removed from affect ed wastewater to an offsit e treatment facility.

The notice shall state that the affected wastewater or resid ual contains organic HAP must

be treated in accordance with the treatment requirements of the Pharmaceutical MACT standards. When the transport is continuous or ongoing, the notice shall be submitted to the treatment operator initially and whenever there is a change in the required treatment.

(b) Pursuant to the Pharmaceutical MA CT standards for wastewater [40 CFR 63.1256(a)(5)(ii)], the Permittee shall not tr ansfer the affected wastewater or residual

unless the transferee has submitted to the EPA a written certificatio n that the transferee will manage and treat any affe cted wastewater or residual removed from affected wastewater received from a source subjec t to the requirements of this subpart in accordance with the treatment requirements of the Pharmaceutical MACT standards.

D.19.2 Receipt of Offsite Affe cted Wastewater for Onsite Tr eatment [40 CFR 63.1256(a)(5)]

(a) Where the Permittee is t he transferee, the Permittee s hall submit to EPA a written certification that it will manage and treat any affected wastewater or residual removed

from affected wastewater received from a so urce subject to the requirements of this subpart in accordance with the treatment requirements of the Pharmaceutical MACT standards for wastewater [40 CFR 63.1256(a)(5)(ii) and (iv)].

(b) The Permittee may revoke its certificat ion as allowed under 40 CFR 63.1256(a)(5)(iii).

Record Keeping and Reporting Requiremen ts [326 IAC 2-7-5(3)] [326 IAC 2-7-19]

D.19.3 Record keeping and Reporting Requirements

(a) The Permittee shall keep records of all notifications required by Conditions D.19.1 and D.19.2 in accordance with 40 CFR 63.1259(g).

Modifications and Construction Requirements [326 IAC 2-7-10.5, 326 IAC 2-7-12 and 326 IAC 2-2]

D.19.4 Modifications and Construction: Adv ance Approval of Permit Conditions

The emission units described in this D section are not subject to the advance approval permit

conditions.Eli Lilly and Company-Tippecanoe Labs 4 th Significant Permit Modificati on No. 157-22717-00006 Page 156 of 226 Lafayette, Indiana Modified by: Aida De Guzman OP No. T157-6879-00006 Permit Reviewer: Dr. Trip Sinha

SECTION D.20 FACILITY OPERATION CONDITIONS

Facility Description [326 IAC 2-7-5(15)]

The information describing the pr ocesses contained in the following facility description boxes is descriptive information and does not constitute enforceable conditions:

(a) The following emissions units are subject to applicable requirements described in this D

section:

Emissions

Unit ID Emissions Unit Description Stack/Vent Nominal Capacity UOM Control

Device

Building T6

BLR001 Natural Gas Boiler No. 1 S-T6-BLR001 50 MMBtu/hr None

BLR002 Natural Gas Boiler No. 2 S-T6-BLR002 50 MMBtu/hr None

BLR003 Natural Gas Boiler No. 3 S-T6-BLR003 50 MMBtu/hr None

BLR004 Natural Gas/Fuel Oil

Boiler No. 4 S-T6-BLR004 142 MMBtu/hr None

BLR005 Natural Gas/Fuel Oil

Boiler No. 5 S-T6-BLR005 97 MMBtu/hr None

Building T26

BLR006 Natural Gas/Fuel Oil

Boiler No. 6 S-T26-

BLR006 156.1 MMBtu/hr None

BLR007 Natural Gas/Fuel Oil

Boiler No. 7 S-T26-

BLR007 156.1 MMBtu/hr None

T26-GEN7500A Natural Powered Emergency Generator S-T26- GEN7500A 150 KW None

T26-COMP

5600A Diesel Powered Emergency Air Compressor S-T26- COMP

5600A 125 Hp None

* Emission units marked with a single asterisk are insi gnificant activiti es as defined in 326 IAC 2-7-1(21).

(b) The following emission units are not subject to applicable requirements described in this D section and are listed only for informational purposes:

Emission

Unit ID Emission Unit Description Stack/Vent Nominal Capacity UOM Control

Device

Outside Building T6:

OILTK001* Fuel Oil Storage Tank PV-T6-
OILTK001 250,000 gallons None

* Emission units marked with a single aste risk are insignificant activities as defi ned in326 IAC 2-7-1(21). Specifically, the fuel oil storage tank is an insignificant activity pursuant to 326 IAC 2-7-1(21)(A)-(C).

Emission Limitations and Standa rds [326 IAC 2-7-5(1)]

D.20.0 Natural Gas Fuel Usage

Boilers No.1, No. 2, and No. 3 shall burn only natural gas on and after September 13, 2007.

D.20.1 General Provisions Relati ng to NSPS and NESHAP [326 IAC 12-1] [40 CFR 60, Subpart A] [40 CFR 63, Subpart A] [326 IAC 20-1]

(a) The provisions of 40 CFR Part 60, S ubpart A - General Provisions, which are incorporated by reference in 326 IAC 12-1, apply to Boilers No. 6 and No.7 described in this section except when otherwise specified in 40 CFR Part 60, Subpart Db.Eli Lilly and Company-Tippecanoe Labs 4 th Significant Permit Modificati on No. 157-22717-00006 Page 157 of 226 Lafayette, Indiana Modified by: Aida De Guzman OP No. T157-6879-00006 Permit Reviewer: Dr. Trip Sinha

(b) Pursuant to 40 CFR 63.7505, the Permittee shall comply with the provisions of 40 CFR Part 63, Subpart A – General Provisions, whic h are incorporated by reference as 326 IAC 20-1-1, for Boilers No. 6 and No.7, as specified in Appendix A of 40 CFR Part 63, Subpart DDDDD in accordance with th e schedule in 40 CFR 63, Subpart DDDDD

.

D.20.2 Opacity Limitations [326 IAC 5] [40 CFR 60.43b] [326 IAC 12] [326 IAC 2-7-24]

(a) Notwithstanding Condition C.2, pursuant to 326 IAC 12 the opacity from Boilers No. 6 and No.7 shall not exceed 20% for any 6-minu te block period, except for one 6-minute period per hour of not more than 27 percent op acity. Pursuant to 326 IAC 12, the opacity limit does not apply during periods of startups, shutdowns, or malfunctions. However, the general opacity requirements of Condition C.2 apply at all times. This condition expires when the revisions made to 40 CFR 60 Subpart Db, as amended on February 27, 2006,

become effective as Indiana law. This co ndition is not federally enforceable.

(b) When starting up or shutting down Boilers No. 6 and No.7, opacity may exceed the applicable limit in Condition C.2. However, opacity levels shall not exceed sixty percent (60%) for any six (6)-minute averaging period. Opacity in excess of the applicable limit established in 326 IAC 5-1-2 shall not continue for more than two (2) six (6)-minute averaging periods in any twenty-four (24) hour period.

(c) Pursuant to 40 CFR 60.43b(h)(5), because Boilers No. 6 and No. 7 will burn only very low sulfur oil or natural gas, the boilers are not subject to opacity limitations in 40 CFR 60.43b(f) and (g).

D.20.3 Sulfur Dioxide (SO 2 ) Limitations [326 IAC 7-1.1-2] [ 40 CFR 60.41b] [40 CFR 60.42b(k)] [326 IAC 12] [326 IAC 2-7-24]

(a) Pursuant to 326 IAC 7-1.1 (SO 2 Emission Limitations), 326 IAC 12, and 40 CFR 60, Subpart Db (Standards of Performance for Industrial-Commercial-Institutional Steam Generating Units):

(1) The SO 2 emission rate from Boilers No. 6 and No.7 shall not exceed 0.32 pounds per million Btu heat input; or

(2) The fuel oil shall contain no more than 0.3 weight percent sulfur.

(3) If the Permittee burns either natural gas or very low sulfur oil, the Permittee shall be in compliance with Conditions D.20.3(a)(1) and (2).

(b) Pursuant to 40 CFR 60 Subpart Db, the fuel oil sulfur content or sulfur dioxide emission limit applies at all times, including periods of startup, shutdown, and malfunction.

(c) Pursuant to 326 IAC 7-1.1-2 (Sulfu r Dioxide Emission Limitations), the SO 2 emissions from Boilers No. 4 and No. 5 shall not exceed 0.5 lb/MMBtu of heat input when burning No. 2 fuel oil. Pursuant to 326 IAC 7-2-1, compliance with this standard is based on a calendar month average. This emission limit correlates to a maximum fuel sulfur content of 0.49 percent by weight.

On and after September 13, 2007, section (c) of this Condition D.20.3 shall apply.

D.20.4 Nitrogen Oxides (NOx) Limitations [40 CFR 60.44b] [326 IAC 12]

Pursuant to 40 CFR 60.44b(a), the NOx emission rate from Boilers No. 6 and No.7 shall not exceed 0.2 lb per MMBtu per boiler. The NOx emission limit shall be based on a 30-day rolling average. The NOx emission limit applies at all time s, including periods of startup, shutdown, and

malfunction.Eli Lilly and Company-Tippecanoe Labs 4 th Significant Permit Modificati on No. 157-22717-00006 Page 158 of 226 Lafayette, Indiana Modified by: Aida De Guzman OP No. T157-6879-00006 Permit Reviewer: Dr. Trip Sinha

D.20.5 Particulate Matter (PM) Limitations [40 CFR 63.7505] [40 CFR Subpart DDDDD, Table 1] [326 IAC 20-1] [326 IAC 6-2-3] [326 IAC 2-7-24]

(a) Pursuant to 326 IAC 6-2-3(b) (Particulate Matter Emission Limitations for Sources of Indirect Heating), particulate emissions from each natural gas-fired boiler (Boilers No. 1, No. 2, and No. 3) shall not exceed 0.56 pounds per million British thermal units (MMBtu) heat input.

(b) Pursuant to 326 IAC 6-2-3(c) (Particulate Matter Emission Limitations for Sources of Indirect Heating), particulate emissions fr om Boiler No. 4 shall not exceed 0.39 pounds per MMBtu heat input.

(c) Pursuant to 326 IAC 6-2-3(c) (Particulate Matter Emission Limitations for Sources of Indirect Heating), particulate emissions fr om Boiler No. 5 shall not exceed 0.31 pounds per MMBtu heat input.

(d) Pursuant to 40 CFR 63 Subpart DDDDD, Table 1, and 326 IAC 6-2-4(a), the PM emission rate from each of Boilers No. 6 and No.7 shall not exceed 0.03 pounds per MMBtu heat input. The particulate matter emissi on limit applies at all times except during periods of startup, shut down, or malfunction.

On and after September 13, 2007, sections (a) throu gh (c) of this Condition D.20.5 shall apply.

D.20.6 Hydrogen Chloride (HCl) Limitations [40 CF R 63.7505] [40 CFR 63 Subpart DDDDD, Table 1][326 IAC 20-1]

Pursuant to 40 CFR 63 Subpart DDDDD, Table 1, the HCl emission rate from Boilers No. 6 and No.7 shall not exceed 0.0005 pounds per MMBtu heat input. The hydrogen chloride emission limit applies at all times except during periods of startup, shutdown, or malfunction.

D.20.7 Carbon Monoxide (CO) Limitations [40 CFR 63 Subpart DDDDD, Table 1] [40 CFR 63.7505] [40 CFR 63.7525] [40 CFR 63.7540] [326 IAC 20-1]

Pursuant to 40 CFR 63, Subpart DDDDD, Table 1, CO emission rate from each of Boilers No. 6 and No.7 shall not exceed 400 ppmdv at 3% O xygen based on a rolling 30-day average. The CO emission limit does not apply during periods of startup, shutdown, malfunction, or when boiler loads are below 50% (40 CFR 63.7540(a)(10)(ii).

D.20.8 PSD Minor Limitations for CO [326 IAC 2-2]

(a) The total carbon monoxide emissions from Boilers No. 6 and No.7 shall be less than 98 tons per twelve consecutive month period with the compliance determined at the end of

each month.

During the first twelve (12) months after start up of either Boilers No. 6 or No. 7, the total carbon monoxide emissions divided by the ac cumulated months of operation shall not exceed 8.17 tons up to a maximum total of 98 tons for the first twelve (12) months of operation of the boilers.

(b) The hours of operation of the emergency ai r compressor shall be limited to 500 hours per year. The Permittee shall monitor the operat ing hours of the emergency air compressor with a non-resettable hour meter, as required by 40 CFR 60.4209(a).

Compliance with the CO emission limit of Boile rs No. 6 and No. 7, and the hours of operation of the emergency air compressor will render 326 IAC 2- 2 (Prevention of Signifi cant Deterioration) not applicable to this modification.Eli Lilly and Company-Tippecanoe Labs 4 th Significant Permit Modificati on No. 157-22717-00006 Page 159 of 226 Lafayette, Indiana Modified by: Aida De Guzman OP No. T157-6879-00006 Permit Reviewer: Dr. Trip Sinha

D.20.9 NSPS Capacity Limitations [AMP approv al 11-22-2005] [326 IAC 12] [40 CFR 60, Subpart Db]

The amount of very low sulfur oil with a maxi mum sulfur content of 0.3%, burned in each of Boilers No. 6 and No. 7 shall be less than 976,740 gallons per year.

This will limit the very low sulfur oil annual capaci ty factors of Boilers No. 6 and No.7 to less than 10 percent. This fuel oil use limit will qualify f uel oil use as “infrequent use” under 40 CFR 60.13(i)(20), which is the requirement of an alter native monitoring plan (AMP) for opacity in lieu of installing continuous opacity monitoring systems.

A quarterly summary of the very low sulfur oil use report shall be submitted with the opacity excess emission report. Each quarterly report must be submitted within 30-days after the end of each quarter (January-March, April-June, July-September, and October-December).

This condition expires when the revisions made to 40 CFR 60 Subpart Db as amended on February 27, 2006, become effective as Indiana law. This condition is not federally enforceable.

D.20.10 Required Plans and Procedures [ 40 CFR Part 63, Subpart DDDDD] [326 IAC 20-1]

(a) Pursuant to 63.7505(d), the Permittee s hall develop and submit to the IDEM, OAQ for approval a site-specific monitoring plan fo r Boilers No. 6 and No. 7 that addresses paragraphs 40 CFR 7505 (d)(1)(i) through (iii) . The Permittee must submit this sitespecific monitoring plan at least 60 days before the initial performance evaluation of
CMS.

(b) Pursuant to 40 CFR 63 7505(e), the Permittee must develop and implement a written startup, shutdown, and malfunction plan (SSMP) for Boilers No. 6 and No. 7 according to the provisions in 40 CFR 63.6(e)(3).

(c) Continuous Emission Monitor Standard O perating Procedures (CEMS SOP) – The Permittee shall prepare and implement a CEMS SOP for each required CEMS. The SOP for the CO monitor shall meet the requi rements of 40 CFR 63.8(d) and (e).

D.20.11 Preventive Maintenance Plan [326 IAC 2-7-5(13)]

A Preventive Maintenance Plan, in accordance wi th Section B - Preventive Maintenance Plan, of this permit, is required for the boilers.

Testing and Monitoring Requirements [326 IAC 2-7-6(1), (6)] [326 IAC 2-7-5(1)]

D.20.12 Opacity Monitoring Requirements [U. S. EPA Alternative Monitoring Plan approval 11/22/2005] [326 IAC 12]

(a) At least six consecutive minutes of visible emission observations of the stack exhaust for

Boilers No. 6 and No.7 must be conducted. These must be conducted at least once during each daylight shift during which fuel oil is being combusted. Visible emissions

must be conducted when the maximum rate of f uel oil for that shift is being burned. The observer conducting the visible emissions must be certified to read visible emissions in
accordance with the United States Envir onmental Protection Agency’s Reference Method 9 (USEPA RM9).

(b) At least six consecutive minutes of visi ble emissions must be conducted for each boiler whenever the respective boiler reaches the ex pected operating load after a cold start-up. These visible emissions readings must be conducted by an observer certified in
accordance with USEPA RM9.Eli Lilly and Company-Tippecanoe Labs 4 th Significant Permit Modificati on No. 157-22717-00006 Page 160 of 226 Lafayette, Indiana Modified by: Aida De Guzman OP No. T157-6879-00006 Permit Reviewer: Dr. Trip Sinha

(c) If visible emissions conducted in accordance with either condition (a) or condition (b) above identify an average opacity exceeding 10 percent, the observer must collect at

least two additional sets of consecutive six minute visible emissions readings within that

hour.

(d) The Permittee must create records of visible emissions in accordance with 40 CFR 60.7.

These records must include at least the dat e and time of visible emission observations along with the results of all readings and average calculated.

(e) If at any time the annual capacity factor for burning very low sulfur oil is 10 percent or more, the Permittee will no longer qualify for th is alternative opacity monitoring plan. The Permittee will then be required to propose a schedule for installing, certifying and operating continuous opacity monitoring sy stem for each boiler identified above.

This condition expires when the revisions made to 40 CFR 60 Subpart Db, as amended on February 27, 2006, become effective as Indiana law. This condition is not federally enforceable.

D.20.13 Compliance Requirements for SO 2 [326 IAC 7-2] [40 CFR 60.45b(j)] [40 CFR 60.47b(f)] [326 IAC 12]

Boilers No. 6 and No. 7 are subject to the following requirements:

(a) The Permittee shall burn only natural gas or very low sulfur fuel oil.

(b) The Permittee shall demonstrate that the oil burned meets the definition of very low sulfur fuel oil by:

(1) Following the performance testing procedures as described in 40 CFR 60.45b(c) or 40 CFR 60.45b(d); or

(2) Maintaining fuel receipts as described in 40 CFR 60.49b(r).

Compliance monitoring is not required when burning very low sulfur fuel oil.

On and after September 13, 2007, this condition shall also apply to Boilers No. 4 and No. 5.

D.20.14 Initial Performance Test Requirements for NOx [40 CFR 60.46 b] [326 IAC 12] [326 IAC 3-6-3] [326 IAC 2-7-24] [326 IAC 2-1.1- 11] [40 CFR Part 60.8]

(a) Within 60 days after achieving the maximum production rate, but no later than 180 days after initial startup, the NOx emissions from Boilers No. 6 and No. 7 shall be monitored for 30 successive steam generating unit oper ating days and the 30-day average emission rate shall be used to determine compliance with the nitrogen oxides emission standards under 40 CFR 60.44b. The 30-day average emission rate is calculated as the average of all hourly emissions data recorded by the monitoring system during the 30-day test period.

(b) Subsequent performance test shall be performed upon request by IDEM, OAQ [40 CFR 60.46b (e) (4)].

D.20.15 Initial and Continuous Compliance Requir ements for PM, HCl and CO [40 CFR 63.7506] [40 CFR 63.7510] [40 CFR 63.7530] [40 CFR 63.7540] [326 IAC 20-1]

(a) The Permittee must demonstrate initial compliance with the emission limits of PM and HCl and CO work practice standard no later than 180 days after startup of Boilers No. 6

and No. 7.Eli Lilly and Company-Tippecanoe Labs 4 th Significant Permit Modificati on No. 157-22717-00006 Page 161 of 226 Lafayette, Indiana Modified by: Aida De Guzman OP No. T157-6879-00006 Permit Reviewer: Dr. Trip Sinha

(b) To demonstrate initial compliance with the emission limits of PM and HCl, the Permittee must include a signed statement in the Notifica tion of Compliance Status report required in 40 CFR 63.7545(e) that indicates the Perm ittee burns only liquid fossil fuels other than residual oils, either alone or in combination with gaseous fuels in Boilers No. 6 and No. 7.

(c) To demonstrate continuous compliance wi th the emission limits of PM and HCl, the Permittee must keep records that demonstrate that the Permittee burns only liquid fossil fuels other than residual oils, either alone or in combination with gaseous fuels in Boilers No. 6 and No. 7. The Permittee must also include a signed statement in each semiannual compliance report required in 40 CFR 63.7550 that indicates the Permittee burns only liquid fossil fuels other than residual oils, either alone or in combination with gaseous fuels, during the reporting period.

(d) To demonstrate initial compliance with the work practice standard for CO, the Permittee shall conduct a performance evaluation of t he continuous emission monitoring system for carbon monoxide according to 40 CFR 63.7525(a).

(e) To demonstrate continuous compliance with the work practice standard for CO, the Permittee shall meet the requireme nts of 40 CFR 63.7540(a)(10).

D.20.16 Continuous Emission Monitoring System (CEMS) Requirements [40 CFR 60.13] [40 CFR 60.48b] [40 CFR 63.7525] [40 CFR 63.8] [326 IAC 2-1.1-11] [326 IAC 2-7-24] [326 IAC 3-5] [ 40 CFR 60.48b (e) (2)] [326 IAC 12] [326 IAC 20-1]

(a) NOx CEMS Operation Requirements – The following requirements shall apply to Boilers No. 6 and No. 7 when burning natural gas and/or fuel oil:

(1) The Permittee shall install, calibrate, maintain, evaluate, and operate the NOx CEMS in accordance with the procedures in 40 CFR 60.13 and 40 CFR 60, Appendix F. The span value for the NOx CEMS shall be 500 ppm. If an Alternative Monitoring Plan (AMP) is approved per 40 CFR 60.13(i), then the

conditions in the AMP shall be followed.

(2) The CEMS shall be operational upon startup of the boilers.

(3) Continuous operation is defined as one data point every 15-minute period.

(4) The NOx emissions shall be calculated using stack flow data, or an appropriate F- Factor per 40 CFR 60 Appendix A, Method 19.

(5) The Standard Operating Procedure (SOP) shall include procedures to obtain emission data when nitrogen oxides em ission data are not obtained because of continuous monitoring system breakdowns, repairs, calibration checks and zero and span adjustments. The emission da ta will be obtained by using standby monitoring systems, Method 7, Method 7A, or other approved reference methods to provide emission data for a minimum of 75 percent of the operating hours in each steam generating unit operating day, in at least 22 out of 30 successive steam generating unit operating days.

(6) The 1-hour average nitrogen oxides em ission rates measured by the continuous nitrogen oxides monitor shall be expressed in lb/MMBTU heat input and shall be used to calculate the average emission rates under 40 CFR 60.44b. The 1-hour averages shall be calculated using the data points required under 40 CFR 60.13(b). At least two data points must be used to calculate each 1-hour

average.

(b) CO and O 2 CEMS Operation Requirements – The following requirements shall apply to Boilers No. 6 and No. 7 when burning natural gas and/or fuel oil:Eli Lilly and Company-Tippecanoe Labs 4 th Significant Permit Modificati on No. 157-22717-00006 Page 162 of 226 Lafayette, Indiana Modified by: Aida De Guzman OP No. T157-6879-00006 Permit Reviewer: Dr. Trip Sinha

(1) The Permittee shall install, operate, and maintain the CO and O 2 CEMS according to Performance Specification (PS) 4A of 40 CFR part 60, appendix B [40 CFR 63.7525(a)(1)] and according to the site-specific monitoring plan developed according to 40 CFR 63.7505(d). If an Alternative Monitoring Plan (AMP) is approved per 40 CFR 63.8(f), then the conditions in the AMP shall be

met and followed.

(2) The CEMS shall be installed and operat ional upon startup of the boilers.

(3) Continuous operation is defined as the collection of at least one measurement for each successive 15-minute period, regardless of startup, shutdown and malfunction. [40 CFR 63.7535(a)(3)]

(4) The 30-day rolling average shall be calc ulated on a daily basis as the average of all of the hourly averages in the prec eding 30 days [40 CFR 63.7525(a)(5).

(5) Data recorded during periods of monitoring malfunctions, associated repairs, outof-control periods, required quality assuranc e or control activities, or when the boiler is operating at less than 50 percent of its rated capacity shall not be used to determine compliance. Any period for which the monitoring system is out of control and data are not available for required calculations constitute a deviation from the monitoring requirements. [63.7525(a)(6)]

(c) CEMS Standard Operating Procedures (SOP) – The Permittee shall prepare and implement an SOP that provides step-by-step procedures and operations in accordance with 326 IAC 3-5-4(a). This includes preventive maintenance procedures and corrective actions that include those procedures taken to ensure continuous operation and to minimize malfunctions. The SOP must be submitted to IDEM within 90 days of installation

of the monitors.

(d) The commissioner may require stack testing, monitoring, or reporting at any time to assure compliance with all applicable requirements. Any monitoring or testing shall be performed in accordance with 326 IAC 3 or other methods approved by the commissioner
or the U.S. EPA.

Record Keeping and Reporting Requirements [326 IAC 2-7-5(3)] [326 IAC 2-7-19]

D.20.17 Record Keeping Requirements

The Permittee shall maintain the following records:

(a) The records of the carbon monoxide emissions, in tons per month, from Boilers No. 6 and No. 7 and hours of operation of the emergency compressor;

(b) The monthly records of the amount of very low sulfur oil burned in each Boilers No. 6 and No. 7, and the capacity factor of each of Boilers No. 6 and No. 7;

This condition expires when the revisions made to 40 CFR 60 Subpart Db as amended on February 27, 2006, become effective as I ndiana law. This condition is not federally

enforceable.

(c) Receipts or test analysis for fuel oil bur ned in Boilers No. 6 and No. 7 certifying that the

fuel oil is less than 0.3% sulfur conten t [40 CFR 60.42b(j), 40 CFR 60.49b(r )];

(d) Daily records of all fuel burned in Boile rs No. 6 and No. 7 [40 CFR 60.49b(d), 40 CFR 63.7555(d)(1)];

(e) Annual capacity factor for each fuel burned in Boilers No. 6 and No. 7 calculated monthly using a 12-month rolling average [40 CFR60.49b(d)];Eli Lilly and Company-Tippecanoe Labs 4 th Significant Permit Modificati on No. 157-22717-00006 Page 163 of 226 Lafayette, Indiana Modified by: Aida De Guzman OP No. T157-6879-00006 Permit Reviewer: Dr. Trip Sinha

(f) Records of any visual opacity reading of Boilers No. 6 and No. 7. These records must

include the date and time of the observati ons, the results of all readings, and the averages calculated;

This condition expires when the revisions made to 40 CFR 60 Subpart Db as amended on February 27, 2006, become effective as I ndiana law. This condition is not federally

enforceable.

(g) NOx Emissions data for each of Boilers No. 6 and No. 7 operating day:

(1) Average hourly NOx emissions in lbs/MMBtu [40 CFR 60.49b(g)(2)];

(2) Rolling 30-day average NOx emissions in lbs/MMBtu [40 CFR 60.49b(g)(3)];

(3) Periods when the 30-day NOx average exceeds the limit in D.20.3 [40 CFR 60.49b (g) (4) and 40 CFR 60.49b (h) (4)];

(4) Days when sufficient data was not obtained [40 CFR 60.49b(g)(5)];

(5) Times and reasons for excluding data [40 CFR 60.49b(g)(6)];

(6) Any F factors used to calculate NOx emissions, method of determination, and type of fuel combusted [40 CFR 60.49b(g)(7)];

(7) Times when full span was exceeded [40 CFR 60.49b(g)(8)];

(8) Description of any modifications to the CEMS that could affect the ability of the system to comply with Performance Standard 2 [40 CFR 60.49b(g)(9)]; and

(9) Results of CEMS daily drift tests an d quarterly accuracy assessments [40 CFR 60.49b(g)(10)].

(h) CO Emissions data for Boilers No. 6 and No. 7:

(1) Each period during which a CMS or CEMS on Boilers No. 6 and No.7 is malfunctioning or inoperative (including out -of-control periods) [40 CFR 63.10(b)];

(2) All required measurements needed to demonstrate compliance with the CO standard for Boilers No. 6 and No.7 (including, but not limited to, 15-minute averages of CEMS data, raw perfor mance testing measurements, and raw performance evaluation measurements, t hat support data that the source is required to report) [40 CFR 63.10(b)];

(3) All results of CEMS performance evaluations [40 CFR 63.10(b)];

(4) All measurements as may be necessary to determine the conditions of performance evaluations [40 CFR 63.10(b)];

(5) All CMS calibration checks [40 CFR 63.10(b)];

(6) All adjustments and maintenance perfor med on the CEMS [40 CFR 63.10(b)];

(7) Previous (i.e., superseded) versions of the CEMS SOP as required in 40 CFR 63.8(d) (3);

(8) Records of the date and time that each deviation started and stopped, and whether the deviation occurred during a period of startup, shutdown, or malfunction or during another period [40 CFR 63.7555 (a) (5)];Eli Lilly and Company-Tippecanoe Labs 4 th Significant Permit Modificati on No. 157-22717-00006 Page 164 of 226 Lafayette, Indiana Modified by: Aida De Guzman OP No. T157-6879-00006 Permit Reviewer: Dr. Trip Sinha

(9) Hourly CO average in ppmdv [63.7525(a)(5)];

(10) 30-day rolling CO average in ppmdv calc ulated as average of all hourly averages in the 30 day period [63.7525(a)(5)]; and

(11) The boiler hourly emissions shall be computed using the data points required under 40 CFR 63.8(g) and 40 CFR 63.2, appropriate F factors, and/or the emission factors in the par agraphs (ii) and (iii):

(i) 1-hour averages shall be computed from four or more data points equally spaced over each 1-hour period, ex cept during periods when calibration, quality assurance, or maintenance activities are being performed. During these periods, a valid hourly average shall consist of at least two data points with each representing a 15- minute period. Alternatively, an arithmetic or integrated 1-hour av erage of CEMS data may be used. At least two equally spaced data points must be used to calculate each 1 - hour average; [40 CFR 63.8(g)]

(ii) When burning natural gas: 84 lbs of CO/million cubic feet of gas burned or 12.9 lbs/hr; and

(iii) When burning fuel oil: 5 lbs of CO /thousand gallons of oil or 5.58 lbs/hr.

(i) Records of the operation of T26-GEN-7500A Diesel Powered Emergency Generator in emergency and non-emergency service. This shall include the time of operation and the reason the engine was in operation at that time [40CFR 60.4214(b)].

(j) Pursuant to 40 CFR 63.10(b), the Permitt ee shall maintain files of all information (including all reports and notifications) required by the general provisions and subpart DDDDD of 40 CFR 63. This subsection is applicable only to Boilers No. 6 and No. 7.

(1) The Permittee shall retain each record for at least 5 years following the date of each occurrence, measurement, maintenance, corrective action, report, or record. The most recent 2 years of records shall be retained at the facility. The remaining 3 years of records may be retained off site;

(2) The Permittee may retain records on microfilm, computer disks, magnetic tape, or microfiche; and

(3) The Permittee shall report required information on paper or on a labeled computer disk.

(k) On and after September 13, 2007, the Permitt ee shall record the information described in item (1) through (4) below on a calendar month basis for Boiler No. 4, and Boiler No. 5:

(1) The amount (expressed in thousands of gallons (Mgal)) of No. 2 fuel oil burned in Boilers No. 4 and No. 5;

(2) The average sulfur content (expressed in percentage by weight) of the No. 2 fuel oil burned in Boilers No. 4 and No. 5;

(3) The average higher heating value (expressed in Btu per gallon) of the No. 2 fuel oil burned in Boilers No. 4 and No. 5; and

(4) The average sulfur dioxide emission rate (expressed in pounds per MMBtu) of

the No. 2 fuel oil for Boilers No. 4 and No. 5.Eli Lilly and Company-Tippecanoe Labs 4 th Significant Permit Modificati on No. 157-22717-00006 Page 165 of 226 Lafayette, Indiana Modified by: Aida De Guzman OP No. T157-6879-00006 Permit Reviewer: Dr. Trip Sinha

D.20.18 Reporting Requirements

(a) A certification shall be submitted to the IDEM , OAQ, stating that only Very Low Sulfur Oil was burned in Boilers No. 6 and No. 7 [40 CFR 60.49b(r)] and a statement that only liquid fossil fuels other than residual oil were burned in Boilers No. 6 and No. 7 [40 CFR 63.7506(a)(2)]. The certification does require t he certification by the “responsible official” as defined by 326 IAC 2-7-1(34).

(b) A quarterly summary of the information to document compliance with Conditions D.20.8 (a) and (b) shall be submitted to the IDEM, OA Q, using the reporting forms located at the end of this permit, or their equivalent, within thirty (30) days after the end of the quarter being reported. The report submitted by the Permittee does require the certification by the “responsible official” as defined by 326 IAC 2-7-1(34).

(c) A quarterly summary of the information to document compliance with Condition D.20.9 and 40 CFR 63.7550(c)(4) shall be submitted to the IDEM, OAQ, using the reporting forms located at the end of this permit, or their equivalent, within thirty (30) days after the end of the quarter being reported. The report submitted by the Permittee does require the certification by the “responsible offici al” as defined by 326 IAC 2-7-1(34).

(d) The following information shall be reported quarterly:

(1) For Boilers No. 6 and No. 7, all NOx emission records described in D.20.17(g) [40 CFR 60.49b(i)];

(2) A statement that only very low sulfur fuel was burned in Boilers No. 6 and No. 7 [40 CFR 60.49b(r)];

(3) The total fuel used by Boilers No. 6 and No. 7 for each calendar month [40 CFR 63.7550(c) (4)];

(4) A statement that no new fuels were burned in Boilers No. 6 and No. 7 [40 CFR 63.7550(c) (6)];

(5) SSM report as described in 40 CFR 63. 10(d)(5)(i) [40 CFR 63.7550(c)(9)];

(6) Description of any deviations occurring in Boilers No. 6 and No. 7 containing the information required by 40 CFR 60.7550 (d ) and (e), or a statement that there were none [40 CFR 63.7550(c)(10)];

(7) Description of any CEMS downtime even ts, or a statement that there were none [40 CFR 63.7550(c)(11)];

(8) An excess emissions report for Boilers No. 6 and No. 7 that identifies any opacity excess emissions, the time and date of the visible emission readings and the total time of the visible emission observations for each date, and the total number of hours that oil was burned during each quarter. Excess emissions are any 6- minute period when the average visible emissions exceeded 20%. If oil was not used, then the report shall indicate that fuel oil was not combusted. [40 CFR 60.49b(h)] This condition expires when the revisions made to 40 CFR 60 Subpart Db, as amended on February 27, 2006, becom e effective as Indiana Law. This condition is not federally enforceable; and

(9) The excess emission report for Bo ilers No. 6 and No. 7 must provide the calculations showing the annual capacity fa ctor for burning fuel oil at each boiler. [Opacity AMP] This condition expires when the revisions made to 40 CFR 60 Subpart Db, as amended on February 27, 2006, become effective as Indiana Law. This condition is not federally enforceable.Eli Lilly and Company-Tippecanoe Labs 4 th Significant Permit Modificati on No. 157-22717-00006 Page 166 of 226 Lafayette, Indiana Modified by: Aida De Guzman OP No. T157-6879-00006 Permit Reviewer: Dr. Trip Sinha

(e) Immediate Reporting Requirements

The reporting requirements in the NESHAP G eneral Provisions for Startup, Shutdown and Malfunction (SSM) Plans [40 CFR 63.6(e)(3 )] shall be used to satisfy the reporting requirements under the NESHAP for Industrial, Commercial, and Institutional Boilers and Process Heaters [40 CRF 63.7505(e)].

(1) Any time an action taken by the Permi ttee during an SSM event of a process is not consistent with the procedures specified in the SSM Plan, the Permittee shall report the actions taken for that event. The immediate report shall be submitted to the IDEM, OAQ via a telephone call or facsimile within 2 working days after commencing actions inconsistent with the plan.

(2) Within 7 working days after the end of an SSM event of a process where an action taken by the Permittee is not consis tent with the procedures specified in the SSM Plan, the Permittee shall submit a letter containing the following information in accordance with 40 CFR 63.10(d)(5):

(A) Name, title and signature of responsi ble official certifying accuracy;

(B) Explanation of the circum stances of the event;

(C) Reason for not following the SSM Plan; and

(D) Report any excess emissions and/ or parameter monitoring exceedances

are believed to have occurred.

(f) On and after September 13, 2007, the Permi ttee shall submit quarterly summary reports of the monthly fuel oil characteristic an d consumption records required by Condition

D.20.17 for Boilers No. 4 and No. 5.

D.20.19 Applicability of 40 CFR Part 63 Subpart ZZZZ-National Emission Standards for Hazardous Air Pollutants for Stationary Reciprocating Inte rnal Combustion Engines (RICE MACT).

The emergency generator or the air compressor has a site-rating of less than 500 brake horsepower. Therefore, the emer gency generator and the air compressor are not subject to the requirements of 40 CFR 63, Subpart ZZZZ (Nati onal Emissions Standards for Hazardous Air Pollutants for Stationary Reciprocating Internal Combustion Engines).Eli Lilly and Company-Tippecanoe Labs 4 th Significant Permit Modificati on No. 157-22717-00006 Page 167 of 226 Lafayette, Indiana Modified by: Aida De Guzman OP No. T157-6879-00006 Permit Reviewer: Dr. Trip Sinha

SECTION E.1 LEAK DETECTION AND REPAIR (LDAR) CONDITIONS FOR BPM PROCESS

SYSTEM COMPONENTS

Facility Description [326 IAC 2-7-5(15)]

The following facility description of LDAR components subject to this permit section is descriptive

information and does not constitute enforceable conditions:

(a) BPM process systems consist of process operations and non-waste storage serving bulk pharmaceutical manufacturing operations. LDAR applies to BPM process system components such as pumps, compressors, agitators, pressure relief devices, sampling connection systems, open-ended valves and lines, valves, connectors, instrumentation systems, control devices, and closed-vent systems intended to operate in volat ile organic hazardous air pollutant and/or volatile organic compound (VOHAP/VOC) service for 300 hours or more during the calendar year. In VOHAP/VOC service means that a piece or equipment either contains or contacts a fluid (liquid or gas) that is at least 5 percent by weight VOHAP/VOC.

(b) LDAR BPM process system components are locate d from the point at which raw material serving the BPM operations is unloaded at the plant site to the point of determination (POD) or point where waste exits the pharmaceut ical manufacturing process unit (PMPU). The closed-vent systems not used to control emissions from LDAR components are not subject to the conditions of this section, but instead are subject to the c onditions in Sections D.14, and D.15, as applicable.

Emission Limitations and Sta ndards [326 IAC 2-7-5(1)]

E.1.1 LDAR Standards for BPM Process System Co mponents [40 CFR 63.1255, 40 CFR 61 Subpart I, 326 IAC 8-5-3(b)(6), 326 IAC 2-2, CP1 57-4148 (Revised by this permit)]

Except as provided in Condition E.1.2, the follo wing LDAR standards satisfy the requirements of the Pharmaceutical Production MACT (Pharma MACT) standards [40 CFR 63.1255], Best Available Control Technology (BACT) require ments [326 IAC 2-2-3], Reasonably Available Control Technology (RACT) LDAR requirements for synthesized pharma ceutical manufacturing operations [326 IAC 8-5-3(b)(6)], and constructi on permit [CP157-4148] requirements for LDAR components associated with the research and development operations in Building T71:

(a) The Permittee shall implement the LDAR program under 40 CFR 63.1255 for all BPM process system comp onent types listed in item (a) of t he facility description section from the point at which raw material serving BPM is unloaded at the plant site to the point of determination (POD) or point where wast e exits the pharmaceutical manufacturing process unit (PMPU).

(b) The Permittee shall conduct an initial monitoring survey that includes the total number of each existing BPM process component type and initial monitoring as follows:

(1) Existing BPM process system componen ts in VOHAP service shall be initially monitored between October 21, 2002 and October 21, 2003.

(2) Existing BPM process system componen ts in VOC service shall be initially monitored for purposes of this permit between October 21, 2002 and October 21,

2003.

(3) Subsequent monitoring periods shall be calendar periods, beginning October 22,

2003.

(c) Each new or changed BPM process system component in VOC/VOHAP service identified during the course of each monitoring period shall be incorporated into the existing component list as necessary within 90 days , or by the next LDAR Periodic Report,Eli Lilly and Company-Tippecanoe Labs 4 th Significant Permit Modificati on No. 157-22717-00006 Page 168 of 226 Lafayette, Indiana Modified by: Aida De Guzman OP No. T157-6879-00006 Permit Reviewer: Dr. Trip Sinha

following the end of the monitoring period for the type of component monitored,

whichever is later.

(d) The following BPM process system components in VOHAP/VOC service shall comply with design standards, shall be operated in acco rdance with work practice standards or shall undergo periodic LDAR monitoring in accordance with the provisions cited below. Periodic LDAR monitoring shall be performed in accordance with 40 CFR 60, Appendix A, Method 21 and 40 CFR 63.1255(b)(4)(v). The regulatory language cited by reference in this section appears in full in Appendix A.

(1) Pumps in light liquid service shall be operated in accordance with the standard at 63.1255(c). This section prov ides, generally and in part:

(A) Single seal pumps shall undergo periodic monitoring and visual inspections;

(B) Dual mechanical seal pumps shall meet design, operation, inspection, and alarm requirements;

(C) Pumps designed without a shaft penetrating the pump housing are not required to be inspected or monitored; and

(D) Pumps equipped with a closed-vent system limitable of capturing and transporting any leakage from the s eals back to the process or to a control device are not required to be inspected or monitored.

(2) Compressors shall be operated in accordance with the standards at 63.1255(b)(3), which requires compliance with 63.164. This section provides, generally and in part:

(A) Compressors with barrier fluid seal systems shall meet design, operation, inspection, and alarm requirements.

(B) Compressors equipped with a closed-vent system to capture and transport leakage from the compressor drive shaft seal back to a process or a fuel gas system or to a c ontrol device are not required to be inspected or monitored.

(C) Compressors designated to operate wi th an instrument reading of less than 500 ppmv above background shall be monitored initially and annually.

(3) Pressure relief devices in gas/vapor service shall be operated in accordance with the standard at 63.1255(b)(3), which requires compliance with 63.165. This section provides, generally and in part:

(A) Except during pressure releases , pressure relief devices shall be operated with an instrument reading of less than 500 ppmv above background.

(B) After each pressure release, the device shall be returned to a monitored condition of less than 500 ppmv above background within 5 calendar days after the release, except if delay of repair applies.

(C) A rupture disk satisfies conditi ons E.1.1 (d)(3)(A ) and (B) without monitoring if it is replaced within 5 calendar days after each pressure release, except if delay of repair applies.Eli Lilly and Company-Tippecanoe Labs 4 th Significant Permit Modificati on No. 157-22717-00006 Page 169 of 226 Lafayette, Indiana Modified by: Aida De Guzman OP No. T157-6879-00006 Permit Reviewer: Dr. Trip Sinha

(D) Any pressure relief device satisfie s conditions E.1.1 (d)(3)(i) and (ii) without monitoring if it is routed to a process or fuel gas system or equipped with a closed-vent system limitable of capturing and transporting leakage from the pressure relief device to a control device.

(4) Sampling connection systems shall be o perated in accordance with the standard at 63.1255(b)(3), which requires complianc e with 63.166. This section provides, generally and in part:

(A) Gases displaced during filling of a sample container are not required to be captured or collected.

(B) Each sampling connection system shall be equipped with a closedpurge, closed-loop or closed-vent system, which shall:

(i) Return the purged process fluid directly to the process line;

(ii) Collect and recycle the pur ged process fluid to a process;

(iii) Be designed and operated to c apture and transport the purged process fluid to a control device;

(iv) Collect, store, and transport the purged process fluid to a SOCMI/HON waste management unit (40 CFR Part 63, Subpart G) operated according to the provisions which apply to Group 1
wastewater streams, or to a treatment, storage, or disposal facility subject to regulation under 40 CFR Part 262, 264, 265 or 266 (a RCRA unit), or, if the purged fluids are not hazardous waste, to a facility with an appropriate State permit to manage municipal or industrial solid waste; or

(v) In-situ sampling systems, and sampling systems without purges, have no other obligations under this section.

(5) Open-ended valves or lines shall be operated in accordance with the standard at 63.1255(d). This section provides, generally and in part:

(A) Each open-ended valve and line shall be equipped with a cap, blind flange, plug or second valve, which shall seal the open end at all times except when operations require flui d flow through the open-ended valve or line, or during maintenance or repair.

(B) The cap, blind flange, plug or second valve shall be in place and closed within one hour of cessation of operations requiring fluid flow through the open-ended valve or line, or maintenance or repair. No records are required to document compliance with this provision.

(C) If a second valve is used, the valve on the process fluid end shall be

closed before the other valve is closed.

(D) If a double block and bleed arrangement is used, the bleed valve may remain open during operations requi ring venting the line between the block valves, but shall be closed ot herwise in accordance with E.1.1 (d)(5)(B).

(E) Open-ended valves and lines in an emergency shutdown system which are designed to open automatically in the event of a process upset are not required to comply with E.1.1 (d)(5)(A) through (C).Eli Lilly and Company-Tippecanoe Labs 4 th Significant Permit Modificati on No. 157-22717-00006 Page 170 of 226 Lafayette, Indiana Modified by: Aida De Guzman OP No. T157-6879-00006 Permit Reviewer: Dr. Trip Sinha

(F) Open-ended valves or lines containing materials, which would autocatalytically polymerize are not required to comply with E.1.1 (d)(5)(A) through (C).

(G) Open-ended valves or lines containing materials which could cause a serious safety hazard if capped or equipped with a double block and bleed system are not required to comply with E.1.1 (d)(5)(A) through (C).

(6) Valves in gas/vapor and light liquid serv ice shall be operated in accordance with the standard at 63.1255(e). This sect ion provides, generally and in part:

(A) Valves shall undergo periodic monitoring.

(B) Each monitoring period shall be determined by a calculation based on the percentage of leaking valves measured in prior monitoring periods.

(C) Valves may be placed into subgroups for periodic monitoring purposes, and may be reassigned among subgroups.

(D) After a leaking valve is repaired, it shall be monitored again within 3 months after repair. This monitoring may be considered part of the periodic monitoring, or may, if conducted prior to the periodic monitoring, be considered separately from the periodic monitoring data in determining percent leaking valves for the monitoring period.

(7) Closed-vent systems and control devices used to comply with LDAR shall be operated in accordance with the standard at 63.1255(b)(4)(ii). Operation of these systems, in conformance with Sections D.9, D.14, or D.15, shall constitute compliance with these requirements;

(8) Agitators in gas/vapor and light liqui d service shall be operated in accordance with the standard at 63.1255(c); This section provides, generally and in part:

(A) Single seal agitators shall undergo periodic monitoring and visual inspections.

(B) Dual mechanical seal agitators sha ll meet design, operation, inspection, and alarm requirements.

(C) Agitators designed without a sha ft penetrating the pump housing are not required to be inspected or monitored.

(D) Agitators equipped with a closed-v ent system limitable of capturing and transporting any leakage from the s eals back to the process or to a control device are not required to be inspected or monitored.

(9) Pumps, valves, connectors, and agitators in heavy liquid service, instrumentation systems, and pressure relief devices in liquid service shall be operated in accordance with the standard at 63.1255( b)(3), which requires compliance with 63.169. This section provides, generally and in part:

(A) If a component presents visual, audibl e, or olfactory evidence of a leak, the leak shall be deemed repaired wit hout monitoring if the component meets any of the following:

(i) The visual, audible, or olfactory evidence has been eliminated;Eli Lilly and Company-Tippecanoe Labs 4 th Significant Permit Modificati on No. 157-22717-00006 Page 171 of 226 Lafayette, Indiana Modified by: Aida De Guzman OP No. T157-6879-00006 Permit Reviewer: Dr. Trip Sinha

(ii) No bubbles are observed at potential leak sites during a leak check using soap solutions; or

(iii) The system will hold a test pressure.

(B) If there is visual, audible, or olfact ory evidence of a leak at one of these components, and the leak is not repaired without monitoring, the component shall be monitored within 5 calendar days to confirm whether a leak is in fact present.

(10) Connectors in gas/vapor and light li quid service shall be operated in accordance with the standard at 63.1255(b)(4)(iii). Th is section provides, generally and in part:

(A) Connectors shall undergo periodic monitoring.

(B) Each monitoring period shall be determined by a calculation based on the percentage of leaking connect ors measured in prior monitoring periods.

(C) Nonrepairable connectors may not be counted in monitoring period

calculations. C AN shall be set to zero in the percent leaking connector

calculation.

(D) Inaccessible, ceramic, or ceramic- lined connectors are not required to be monitored, and are exempt from reco rd keeping and reporting. If they are observed to be leaking, they shall be repaired as soon as practicable, but no later than 15 calendar days after the leak is detected, except if delay of repair applies. There is no obligation to make a first attempt at repair within 5 days.

(E) Connectors that are not required to be monitored are not included in the calculation of the percentage of leaking connectors.

(F) An optional credit may be taken for removed connectors where the weld

meets certain test ing requirements.

(e) As an alternative to complying with E.1.1( d), except E.1.1(d)(7), BPM process system components may comply with 63.1255(b)(4)( iv), which incorporates by reference 63.178(b) (Alternative Means of Emission Limitation: Batc h Processes) as follows:

(1) Components shall be pressure tested each time the equipment is reconfigured for production of a different product or in termediate or at least once per calendar year, whichever is more stringent. The pressure testing shall be conducted in accordance with 63.180(f) or (g); and

(2) Components must comply with the leak repair requirements before startup of a process as described in 63.178(b)(4).

(f) As an alternative to complying with E.1.1 (d), except E.1.1 (d)(7), BPM process system components may comply with.179 (Alternative means of emission limitation: Enclosedvented process units), which requires that pr ocess units be enclosed in such a manner that all emissions from equipment leaks are vented through a closed-vent system to a

control device. The enclosure is to be mainta ined under a negative pressure at all times while the process unit is in operation to ensur e that all emissions are routed to the control device. The closed vent system and control device must comply with E.1.1 (d)(7).

(g) Any visible leak of a liquid containing VOHAP/VOC shall be considered a leak for purposes of the obligation to repair. If it is not clear whether the liquid containsEli Lilly and Company-Tippecanoe Labs 4 th Significant Permit Modificati on No. 157-22717-00006 Page 172 of 226 Lafayette, Indiana Modified by: Aida De Guzman OP No. T157-6879-00006 Permit Reviewer: Dr. Trip Sinha

VOHAP/VOC, then Method 21 may be used to c onfirm whether a leak exists. For each component type, the relevant leak definiti on and leak repair requirements in E.1.1 (d) shall apply for this purpose. All leaks shall be marked as provided in 63.1255(a)(10).

(h) The Permittee shall initiate repair of any leak no later than 5 calendar days after identification, and complete the repair within 15 days after identification, except where delay of repair is allowed under 1255(b)(4)(i), which incorporates by reference 63.171. This shall not affect repair periods under Condi tions E.1.1 (d)(3) or (e). 63.1255(b)(4)(i) provides, generally and in part:

(1) Delay of repair of equipment for which leaks have been detected will be allowed if repair within 15 days is technically infeasible without a process unit shutdown. Repair of this equipment shall occu r before the end of the next scheduled process unit shutdown.

(2) Delay of repair for equipment for which leaks have been detected is allowed if the owner or operator determines that repair personnel would be exposed to an immediate danger if attempting to repair without a process shutdown. Such repair shall occur by the end of the nex t scheduled process shutdown.

(3) Delay of repair of equipment for which leaks have been detected will be allowed for equipment that is isolated from the process and that does not remain in
VOC/VOHAP service.

(4) Delay of repair for valves, connectors , and agitators will be allowed if emissions immediate repair would result in greate r emissions than delay of repair, and if purged material generated during the repair is collected and destroyed or

recovered in a control device.

(5) Delay of repair for pumps will be allowed if the repair requires the use of a dual mechanical seal system, or a pump designed without an externally actuated shaft penetrating the pump housing, or ducting of the pump fugitive emissions to a closed vent system and control device, and is completed within 6 months.

(6) Delay of repair beyond a process unit sh utdown will be allowed for a valve if valve assembly replacement is necessary during the process unit shutdown, but the supplies, although adequately stock ed, have been depleted. Delay of repair beyond the second process unit shutdown is not allowed unless the second

shutdown occurs sooner than 6 months after the first shutdown.

(i) Alternative means of emission limitatio ns not already included in 63.1255 may be approved in accordance with 63.1255(b)(3), which incorporates by reference 63.177.

E.1.2 Exceptions to LDAR Standards for BPM Process System Components

(a) The following facilities are not subject to the LDAR standards under this section of the permit:

(1) Research and development facilities, activities and equipment (40 CFR 63.1250(d)) not subject to BACT or construction permit requirements;

(2) Condition E.1.2(a)(2) was deleted pursu ant to Administrative Permit Amendment 157-20003-00006.;

(3) Utilities and non-process lines (40 CFR 63.1255(a)(5));

(4) Bench scale processes (40 CFR 63.1255(a)(6));

(5) Equipment in vacuum service (40 CFR 63.1255(a)(8));Eli Lilly and Company-Tippecanoe Labs 4 th Significant Permit Modificati on No. 157-22717-00006 Page 173 of 226 Lafayette, Indiana Modified by: Aida De Guzman OP No. T157-6879-00006 Permit Reviewer: Dr. Trip Sinha

(6) Waste components (covered by Section E.2 of this permit).

(7) Fermented Products operations;

(8) Equipment in VOHAP/VOC service but that is in such service less than 300 hours per calendar year (40 CFR 63.1255(a)(9));

(9) Closed loop heat exchange sy stems (40 CFR 63.1255(a)(5)); and

(10) Welded fittings (40 CFR 63.1251).

(b) Equipment that is designated as unsafe to moni tor, unsafe to inspect, difficult to monitor, difficult to inspect, or inacce ssible shall comply with 63.1255(f). This section provides, generally, that accessible equipment shall be monitored according to a written plan that provides for monitoring as often as practicabl e, considering safety concerns, but not more often than otherwise applicable. Inaccessible equipment is not required to be routinely monitored at any time, although any observ ed leaks must be repaired within 15 days.

Record Keeping and Reporting Requiremen ts [326 IAC 2-7-5(3)] [326 IAC 2-7-19]

E.1.3 Record Keeping and Reporting Requirements [326 IAC 2-7-5(3)]

(a) Records shall be kept in accordance with 63.1255(g), including but not limited to:

(1) Identification of components that are subject to the rule with information indicating their method of compliance, with justifications as a ppropriate, except that inaccessible, ceramic, or cera mic-lined connectors subject to 40 CFR 63.1255(f)(4) need not be identified;

(2) Schedule for monitoring connectors and valves and the percent connectors and valves found leaking;

(3) Design criteria and any changes to these criteria for each dual mechanical seal system;

(4) List of equipment designated as unsafe to monitor/inspect or difficult to monitor/inspect and a copy of the plan for monitoring or inspecting such equipment;

(5) Equipment complying via the pr ovisions of 40 CFR 63.178(c);

(6) List of equipment added since the last monitoring period, and

(7) If monitoring frequencies are adjusted for time in use, records demonstrating the proportion of the time the equipment is in VOC/VOHAP use during the calendar

year;

(8) Records of visual inspections;

(9) Records of leaks detected, repai r information, and delays of repair;

(10) Records of pressure tests, the test pressure, and the pressure drop observed during the test;

(11) Records of compressor and relief device compliance tests;

(12) Records for closed-vent systems and co ntrol devices subject to E.1.1(d)(7);Eli Lilly and Company-Tippecanoe Labs 4 th Significant Permit Modificati on No. 157-22717-00006 Page 174 of 226 Lafayette, Indiana Modified by: Aida De Guzman OP No. T157-6879-00006 Permit Reviewer: Dr. Trip Sinha

(13) For components in heavy liquid service, records demonstrating that they are in heavy liquid service;

(14) Identification of components exempt because they are in VOHAP/VOC service for less than 300 hours per year; and

(15) Records of alternative means of compliance determination.

(b) Condition E.1.3(b) was deleted pursuant to Administrative Permit Amendment 157-

20003-00006.

(c) Reporting requirements shall be conducted in accordance with 63.1255(h), including:

(1) LDAR Periodic Reports shall cover the monitoring periods from January 1 to June 30, and July 1 to December 31, respectively. Reports shall be submitted 30 days following the 6-month monitoring per iod. The report shall include any revisions to the information reported ea rlier if the method of compliance has changed since the last report. The report shall also contain the following

information:

(A) For equipment not complying via t he alternative standard, the Permittee shall report the following information for pumps, valves, agitators, and connectors subject to per iodic LDAR monitoring:

(i) Number of leaks detec ted and percent leakers;

(ii) Number of leaks not repaired within the required timeframe;

(iii) An explanation of any delay of repairs;

(iv) Notice of a change to monthly monitoring for either pumps or valves, if applicable; and

(v) Notification of a change in connector monitoring alternatives, if applicable.

(B) Results of all monitoring required for applicable compressors, pressure relief devices in gas/vapor service, and closed-vent systems;

(i) Number of leaks not repaired within the required timeframe; and

(ii) An explanation of any delay of repairs.

(C) For equipment complying via the alternative standard at 1255(b)(4)(iv), the Permittee shall report the fo llowing information for each product process equipment train:

(i) Number of pressure tests conducted;

(ii) Number of instances where t he equipment failed either a retest

or 2 consecutive pressure tests;

(iii) Facts that explain any delay of repairs; and

(iv) Results of all monitoring to determine compliance for closed-vent systems used to comply with this section of the permit.Eli Lilly and Company-Tippecanoe Labs 4 th Significant Permit Modificati on No. 157-22717-00006 Page 175 of 226 Lafayette, Indiana Modified by: Aida De Guzman OP No. T157-6879-00006 Permit Reviewer: Dr. Trip Sinha

Modifications and Construction Requirements [326 IAC 2-7-10.5, 326 IAC 2-7-12, 326 IAC 2-2]

E.1.4 Modifications and Construction: Adv ance Approval of Permit Conditions

(a) The Permittee may modify any existing comp onents listed in this section of the permit without obtaining a source modification appr oval (otherwise required by 326 IAC 2-7- 10.5), a Title V permit modification (otherwise required by 326 IAC 2-7-12), or a Prevention of Significant Deterioration permit (otherwise required by 326 IAC 2-2), provided the modified emission units are s ubject to the same applicable requirements listed in this D section, and the Permittee shall comply with the Change Management and Flexible Permit provisions in Section F.1 of this permit.

(b) The Permittee may construct and install new em ission units of the types described in this D section without obtaining a source modifica tion approval (otherwise required by 326 IAC 2-7-10.5), a Title V permit modification (otherwise required by 326 IAC 2-7-12), or a Prevention of Significant Deterioration permit (otherwise required by 326 IAC 2-2), provided the new emission units are subject to the same applicable requirements listed in this D section, and the Permittee shall comply with the Change Management and Flexible Permit provisions in Section F.1 of this permit.

The remainder of the page is left blank intentionally.Eli Lilly and Company-Tippecanoe Labs 4 th Significant Permit Modificati on No. 157-22717-00006 Page 176 of 226 Lafayette, Indiana Modified by: Aida De Guzman OP No. T157-6879-00006 Permit Reviewer: Dr. Trip Sinha

SECTION E.2 LEAK DETECTION AND REPAIR (LDAR) CONDITIONS FOR BPM WASTE SYSTEM

COMPONENTS

Facility Description [326 IAC 2-7-5(15)]

The following facility description of LDAR components subject to this permit section is descriptive

information and does not constitute enforceable conditions:

(a) LDAR applies to BPM waste system component s consisting of pumps, compressors, pressure relief devices, sampling connection systems, ope n-ended valves and lines, valves, connectors, control devices, and closed-vent systems used to comply with this LDAR program, intended to operate in volatile organic hazardous air pollutant and/or volatile organic compound (VOHAP/VOC) service for 300 hours or more during the calendar year. In VOHAP/VOC service means that a piece or equipment either contains or contacts a fluid (liquid or gas) that is at least 10 percent by weight of total VOHAP/VOC.

(b) LDAR BPM waste system components are located from the point of generation (POG) or point of determination (POD), as applicable, to the last component prior to entering the hazardous waste combustor or being loaded onto tankers for transport offsite. The closed-vent systems not used to control emissions from LDAR components are not subject to the conditions of this section, but instead are subject to the conditions in Sections D.10, D.14, and D.15.

Emission Limitations and Sta ndards [326 IAC 2-7-5(1)]

E.2.1 LDAR Standards for BPM Waste System Co mponents [40 CFR 63.691, 326 IAC 8-5-3(b)(6), 326 IAC 2-2, CP157-4148 (Rev ised by this permit)]

Except as provided in Condition E.2, the followi ng LDAR standards satisfy the requirements of the Volatile Organic Liquid Storage Vessel Standards [40 CFR 60.110b], Offsite Waste and Recovery Operations (OSWRO) MACT Standards [40 CFR 63.691], Best Available Control Technology (BACT) requirements [326 IAC 2-2- 3], Reasonably Available Control Technology (RACT) LDAR requirements for synthesized phar maceutical manufacturing operations [326 IAC 8-5-3(b)(6)], and construction permit [CP157- 4148] requirements for LDAR components

associated with the research and devel opment operations in Building T71:

(a) The Permittee shall implement the LDAR program under 40 CFR 61 Subpart V for all BPM waste system component types listed in it em (a) of the facility description section from the point of determination (POD) or at the exit of the pharmaceutical manufacturing process unit (PMPU) to the last piece of regulated equipment prior to entering the

hazardous waste combustor or loaded onto tankers for transport offsite.

(b) Existing BPM waste system components in VOC/VOHAP service are covered under 40 CFR 264 and 265, Subpart BB. Data taken fo r purposes of Subpart BB shall satisfy the data requirements for entry into the alter nate standard at 40 61.243-3. Monitoring periods are calendar periods as defined at 40 CFR 61 Subpart V and 40 CFR 264 and 265, Subpart BB.

(c) Each new or changed BPM waste system component in VOC/VOHAP service identified during the course of each monitoring period shall be incorporated into the existing component list as necessary within 90 days , or by the next LDAR Periodic Report, following the end of the monitoring period for the type of component monitored,

whichever is later.

(d) The following BPM waste system components in VOHAP/VOC service shall comply with design standards, shall be operated in accordance with work practice standards, or shall undergo periodic LDAR monitoring in accordance with the provisions cited below. Periodic LDAR monitoring shall be performed in accordance with 40 CFR 60, Appendix A, Method 21. The regulatory language cited by reference in this section appears in full in Appendix A.Eli Lilly and Company-Tippecanoe Labs 4 th Significant Permit Modificati on No. 157-22717-00006 Page 177 of 226 Lafayette, Indiana Modified by: Aida De Guzman OP No. T157-6879-00006 Permit Reviewer: Dr. Trip Sinha

(1) Pumps shall be operated in accordance with the standard at 61.242-2. This section provides, generally and in part:

(A) Single seal pumps shall undergo periodic monitoring and visual inspections.

(B) Dual mechanical seal pumps shall meet design, operation, inspection, and alarm requirements.

(C) Pumps designed without a shaft penetrating the pump housing shall be monitored initially and annually, but ar e not subject to other inspections.

(D) Pumps equipped with a closed-vent system limitable of capturing and transporting any leakage from the s eals back to the process or to a control device are not required to be inspected or monitored.

(E) Pumps designated as unsafe-to-monitor shall be monitored according to a written plan by which they are m onitored as frequently as possible during safe-to-monitor times, but not more frequently than otherwise applicable.

(2) Compressors shall be operated in acco rdance with the standard at 61.242-3. This section provides, generally and in part:

(A) Compressors with barrier fluid seal systems shall meet design, operation, inspection, and alarm requirements.

(B) Compressors equipped with a closed-vent system to capture and transport leakage from the compressor drive shaft seal back to a process or a fuel gas system or to a c ontrol device are not required to be inspected or monitored.

(C) Compressors designated to operate wi th an instrument reading of less than 500 ppmv above background shall be monitored initially and annually.

(3) Pressure relief devices in gas/vapor service shall be operated in accordance with

the standard at 61.242-4. This sect ion provides, generally and in part:

(A) Except during pressure releases , pressure relief devices shall be operated with an instrument reading of less than 500 ppmv above background.

(B) After each pressure release, the device shall be returned to a monitored condition of less than 500 ppmv above background within 5 calendar days after the release, except if delay of repair applies.

(C) A rupture disk is satisfies cond itions E.2.1 (d)(3)(A) and (B) without monitoring if it is replaced within 5 calendar days after each pressure release, except if delay of repair applies.

(D) Any pressure relief device satisf ies conditions E.2.1 (d)(3)(A) and (B) without monitoring if it is routed to a process or fuel gas system or equipped with a closed-vent system limitable of capturing and transporting leakage from the pressure relief device to a control device.

(4) Sampling Connection Systems shall be oper ated in accordance with the standard at 61.242-5. This section provides, generally and in part:Eli Lilly and Company-Tippecanoe Labs 4 th Significant Permit Modificati on No. 157-22717-00006 Page 178 of 226 Lafayette, Indiana Modified by: Aida De Guzman OP No. T157-6879-00006 Permit Reviewer: Dr. Trip Sinha

(A) Gases displaced during filling of a sample container are not required to be captured or collected.

(B) Each sampling connection system shall be equipped with a closedpurge, closed-loop or closed-vent system, which shall:

(i) Return the purged process fluid directly to the process line;

(ii) Collect and recycle the purged process fluid;

(iii) Be designed and operated to c apture and transport the purged process fluid to a control device;

(iv) Collect, store, and transport the purged process fluid to a SOCMI/HON waste management unit (40 CFR Part 63, Subpart G) operated according to the provisions which apply to Group 1
wastewater streams, or to a treatment, storage, or disposal facility subject to regulation under 40 CFR Part 262, 264, 265 or 266 (a RCRA unit), or, if the purged fluids are not hazardous waste, to a facility with an appropriate State permit to manage municipal or industrial solid waste; or

(v) In-situ sampling systems, and sampling systems without purges, have no other obligations under this section.

(5) Open-ended valves or lines shall be operated in accordance with the standard at 61.242-6. This section provides, generally and in part:

(A) Each open-ended valve and line shall be equipped with a limit, blind flange, plug or second valve, which shall seal the open end at all times except when operations require flui d flow through the open-ended valve or line, or during maintenance or repair.

(B) If a second valve is used, the valve on the process fluid end shall be

closed before the other valve is closed.

(C) If a double block and bleed arrangement is used, the bleed valve may remain open during operations requi ring venting the line between the block valves, but shall be closed ot herwise in accordance with E.2.1 (d)(5)(B).

(D) Open-ended valves and lines in an emergency shutdown system which are designed to open automatically in the event of a process upset are not required to comply with E.2.1 (d)(5)(A) through (C).

(E) Open-ended valves or lines containing materials, which would autocatalytically polymerize are not required to comply with E.2.1 (d)(5)(A) through (C).

(F) Open-ended valves or lines containing materials which could cause a serious safety hazard if capped or equipped with a double block and bleed system are not required to comply with E.2.1 (d)(5)(A) through (C).

(6) Valves shall be operated in accordan ce with the standard at 61.242-7. This section provides, generally and in part:

(A) Each valve shall be monitored m onthly, except as provided below.Eli Lilly and Company-Tippecanoe Labs 4 th Significant Permit Modificati on No. 157-22717-00006 Page 179 of 226 Lafayette, Indiana Modified by: Aida De Guzman OP No. T157-6879-00006 Permit Reviewer: Dr. Trip Sinha

(B) Any valve may be monitored quarterly, in the first month of the quarter, if it has completed two successive months without a leak, as long as it

does not leak.

(C) Each leaking valve shall be monitored monthly after it is repaired until it has completed two successive months without a leak.

(D) Valves designed for no detectable emissions, which have no external actuating mechanism in contact with process fluid, are required only to be monitored initially and annually.

(E) Valves designated as unsafe-to-monitor are required to be monitored only according to a written plan, which provides for their monitoring during safe-to-monitor times.

(F) Valves designated as difficult-to-monitor are required to be monitored only according to a written plan that provides for their monitoring at least

once per year.

(7) Pressure relief devices in liquid se rvice and connectors shall be operated in

accordance with the standard at 61.242-8 This section provides, generally and in part:

(A) If a component presents visual, audibl e, or olfactory evidence of a leak, the leak shall be deemed repaired wit hout monitoring if the visual, audible, or olfactory evidence has been eliminated.

(B) If there is visual, audible, or olfact ory evidence of a leak at one of these components, and the leak is not repaired without monitoring, the component shall be monitored within 5 calendar days to confirm whether a leak is in fact present.

(8) Closed-vent systems and control devices used to comply with Section E.2 of this permit shall be operated in accordance wi th the standard at 61.242-11, as may be applicable. Operation of these systems in conformance with Sections D.9, D.14 or D.15 shall constitute compliance with these requirements.

(9) As an alternative to complying with E.2. 1 (d)(6), above, valves may comply with

the alternative standards for valves-allo wable percentage of valves leaking under 61.243-1. This section provides, generally and in part:

(A) Upon 90 days’ advance notice to the Administrator, the designated process unit shall have no more than 2.0 percent leaking valves.

(B) All valves in the designated process unit shall be monitored initially upon designation, and annually thereafter, and

(C) The annual monitoring of all valv es in the designated process unit shall be completed within one week.

(D) Valve leaks detected shall be repaired within 15 days, except if delay of repair applies, in accordance with 40 CFR 61.242-7(d) and (e).

(10) As an alternative to complying with the monitoring requirements in E.2.1 (d)(6), above, with respect to monitoring requirements alone, valves may comply with

the alternative standards for valves-ski p period leak detection and repair under 61.243-2. This section provides, generally and in part:Eli Lilly and Company-Tippecanoe Labs 4 th Significant Permit Modificati on No. 157-22717-00006 Page 180 of 226 Lafayette, Indiana Modified by: Aida De Guzman OP No. T157-6879-00006 Permit Reviewer: Dr. Trip Sinha

(A) All valves in the proc ess unit shall comply initially with the monitoring requirements of E.2.1 (d)(6).

(B) After 2 consecutive quarterly monito ring periods with the percent leaking valves in the process unit at less than or equal to 2.0 percent, upon 90 days’ advance notice to the Administrator, the designated process unit may begin to skip one of the quarterly monitoring periods.

(C) After 5 consecutive quarterly monito ring periods with the percent leaking valves in the process unit at less than or equal to 2.0 percent, upon notice to the Administrator, the designated process unit may begin to skip three of the quarterly monitoring periods.

(D) If for any monitoring period the perc entage of leaking valves exceeds 2.0 percent, all valves in the process uni t shall comply with the monitoring requirements of E.2.1 (d)(6), but may again elect to use this alternative.

(e) Any visible leak of a liquid containing VOHAP/VOC shall be considered a leak for purposes of the obligation to repair. If it is not clear whether the liquid contains VOHAP/VOC, then Method 21 may be used to c onfirm whether a leak exists. For each component type, the relevant leak definition in E.2.2 (d) shall apply for this purpose. All leaks shall be marked as provided in 40 CFR 61.246(b) with a weatherproof and readily visible identification marked with the equipment identification number. This identification may be removed from the equipment after it has been successfully repaired, except that the identification on a leaking valve may not be removed until the valve has been monitored for 2 successive months without a leak being detected.

(f) The Permittee shall initiate repair of any leak no later than 5 calendar days after identification, and complete the repair within 15 days after identification, except where delay of repair is allowed under 40 CFR 61.242 -10. This shall not affect repair periods under Condition E.2.1 (d)(3). 40 CFR 61.242-10 provides, generally and in part:

(A) Delay of repair of equipment for which leaks have been detected will be allowed if repair within 15 days is technically infeasible without a process unit shutdown. Repair of this equipment shall occur bef ore the end of the next process unit

shutdown.

(B) Delay of repair of equipment for which leaks have been detected will be allowed for equipment that is isolated from the process and that does not remain in
VOC/VOHAP service.

(C) Delay of repair for valves will be allo wed if emissions immediate repair would result in greater emissions than delay of repair, and if purged material generated during the repair is collected and destroy ed or recovered in a control device.

(D) Delay of repair for pumps will be allowe d if the repair requires the use of a dual mechanical seal system, and is completed within 6 months.

(E) Delay of repair beyond a process unit sh utdown will be allowed for a valve if valve assembly replacement is necessary during the process unit shutdown, but the supplies, although adequately stock ed, have been depleted. Delay of repair beyond the second process unit shutdown is not allowed unless the second

shutdown occurs sooner than 6 months after the first shutdown.

(g) Alternative means of emission limitations not already included in 40 CFR 61, Subpart V may be approved in accordance with 40 CFR 61.242-1(d) and 61.244Eli Lilly and Company-Tippecanoe Labs 4 th Significant Permit Modificati on No. 157-22717-00006 Page 181 of 226 Lafayette, Indiana Modified by: Aida De Guzman OP No. T157-6879-00006 Permit Reviewer: Dr. Trip Sinha

E.2.2 Exceptions to LDAR Standards for BPM Waste System Components

The following equipment types are not subject to the LDAR standards described in E.2.1:

(a) Research and development facilities, activities and equipment;

(b) Components on transportation equipment and containers such as tanker trucks, railroad cars, and drums (40 CFR 63.1256 and 40 CFR 63, Subpart DD);

(c) BPM process systems including non-waste storage and process operations (covered by Section E.1 of this permit);

(d) Utilities and non-process lines;

(e) Components in vacuum service (40 CFR 61.242-1);

(f) Equipment in VOC/VOHAP service that is in such service less than 300 hours per calendar year (40 CFR 63.680(c)(3)(iii)); and

(g) Closed loop heat exchange systems.

Record Keeping and Reporting Requiremen ts [326 IAC 2-7-5(3)] [326 IAC 2-7-19]

E.2.3 Record Keeping and Reporting Requirements

(a) Records shall be kept in accordance with 61.246, including but not limited to:

(1) Identification of components that are subject to the rule with information indicating their method of compliance, wi th justifications and signatures as appropriate. No identification is required for welded fittings;

(2) For valves complying via the “skip peri od” alternative, a schedule for monitoring the valves and the percent valves found leaking during each monitoring period;

(3) Changes to each dual mechanical seal system design and operating criteria, including seal system failure criteria;

(4) List of equipment designated as unsafe to monitor/inspect or difficult to monitor/inspect, with the reason for the designation, and a copy of the plan for monitoring or inspecting such equipment;

(5) Records of leaks detected, repai r information, and delays of repair;

(6) Records of compliance tests on equipment (compressors, pumps, or valves) designated for no detectable emissions a nd for pressure relief devices in gas/vapor service;

(7) Records for closed-vent systems and co ntrol devices, subject to E.2.1 (d)(8);

(8) Records of information supporting de signation that components are not in VOHAP/VOC service or are in vacuum service;

(9) Identification of components exempt because they are in VOC/VOHAP service for less than 300 hours per year;

(10) Records of alternative means of compliance determination; andEli Lilly and Company-Tippecanoe Labs 4 th Significant Permit Modificati on No. 157-22717-00006 Page 182 of 226 Lafayette, Indiana Modified by: Aida De Guzman OP No. T157-6879-00006 Permit Reviewer: Dr. Trip Sinha

(11) Records may be kept in one or more recordkeeping systems, providing each record is identified by process unit.

(b) Condition E.2.3(b) was deleted pursuant to Administrative Permit Amendment 157-

20003-00006.

(c) Reporting requirements shall be conduct ed in accordance with 61.247, including:

(1) LDAR Periodic Reports shall cover the periods from January 1 to June 30, and July 1 to December 31, respectively. Reports shall be submitted 30 days following the 6-month period. The report shall include any revisions to the information reported earlier if the met hod of compliance has changed since the last report. The report shall also c ontain the following information, divided and identified by process unit:

(A) For each month during the period covered by the report, the number of leaks detected for valves, pumps, and compressors and the number not repaired within 15 days, with the fact s that explain any delay of repairs, and, where appropriate, why a proc ess unit shutdown was technically infeasible;

(B) The results of all performance tests and monitoring to determine compliance with the alternative st andards for valves at 40 CFR 61.243-1 and 61.243-2;

(C) Results of all monitoring and per formance tests required to determine compliance with no detectable emissions; and

(D) The dates of process unit shutdowns which occurred during the reporting period.

Modifications and Construction Requirements [3 26 IAC 2-7-10.5, 326 IAC 2-7-12, 326 IAC 2-2]

E.2.4 Modifications and Construction: Ad vance Approval of Permit Conditions

(a) The Permittee may modify any existing emissi on units listed in this section of the permit without obtaining a source modification appr oval (otherwise required by 326 IAC 2-7- 10.5), a Title V permit modification (otherwise required by 326 IAC 2-7-12), or a Prevention of Significant Deterioration permit (otherwise required by 326 IAC 2-2), provided the modified emission units are s ubject to the same applicable requirements listed in this D section, and the Permittee shall comply with the Change Management and Flexible Permit provisions in Section F.1 of this permit.

(b) The Permittee may construct and install new em ission units of the types described in this D section without obtaining a source modifica tion approval (otherwise required by 326 IAC 2-7-10.5), a Title V permit modification (otherwise required by 326 IAC 2-7-12), or a Prevention of Significant Deterioration permit (otherwise required by 326 IAC 2-2), provided the new emission units are subject to the same applicable requirements listed in this D section, and the Permittee shall comply with the Change Management and Flexible Permit provisions in Section F.1 of this permit.Eli Lilly and Company-Tippecanoe Labs 4 th Significant Permit Modificati on No. 157-22717-00006 Page 183 of 226 Lafayette, Indiana Modified by: Aida De Guzman OP No. T157-6879-00006 Permit Reviewer: Dr. Trip Sinha

SECTION F.1 Change Management and Flexible Permit Conditions

Facility description [326 IAC 2-7-5(15)]

The information described in the following paragraphs is descriptive information and does not constitute

enforceable conditions:

(a) The areas of the plant site listed below are su bject to the change management and flexible permit

conditions described in this F section. These conditions apply to all emission units listed in the specific sections of the permit listed below and emission units added to the site pursuant to the provisions of this section:

(1) D.6 BPM - Process Operations [referred to as “BPM”] (2) D.7 BPM Support – Solvent Recovery Operations (3) D.8 BPM Support – Individual Drain Systems (4) D.9 BPM Support – Solvent Storage Tank Operations (5) D.10 BPM Support – Waste Storage Tank Operations (6) D.11 BPM Support – Waste Containers (7) D.12 BPM Control Systems – T49 Liquid Waste Incinerator (8) D.13 BPM Control Systems – T1 49 Solids-Liquid Waste Incinerator (9) D.14 BPM Control Systems – RTO Operations (10) D.15 BPM Control Systems – T79 Fume Incinerator Operations

(b) The following operation is not subject to t he change management provisions of this section except for the VOC emission limit require ments in Sections F.1.1(e) and F.1.7(c):

(1) D.18 BPM Support – Chemical Wastewater Treatment Plant

(c) The operations in the areas listed below are not subject to the change management and flexible permit conditions in this G section:

(1) D.1 Utilities (2) D.2 Utilities Support (3) D.3 – D.5 Fermented Products (4) D.16 Research and Development Operations (5) D.19 BPM Transfer Activities (6) Insignificant Activities described in Section A and outside the BPM production and support operations

Emission limits and standa rds [326 IAC 2-7-5(1)]

F.1.1 Emission limits [326 IAC 2-2]

(a) Carbon monoxide (CO) emissions from the fa cilities operating under the flexible permit conditions shall not exceed 150 tons per 12-month period, rolled on a calendar month
basis. Carbon monoxide emissions from the T79 fume incinerators shall not exceed 30 tons per 12-month period, rolled on a calendar month basis.

(b) Fluoride (F) emissions from the facilities operating under the flexible permit conditions shall not exceed 6 tons per 12-month period, rolled on a calendar month basis. Fluoride emissions from the T79 fume incinerators shall not exceed 2 tons per 12-month period,

rolled on a calendar month basis.

(c) Nitrogen oxides (NOx) emissi ons from the facilit ies operating under the flexible permit conditions shall not exceed 300 tons per 12-month period, rolled on a calendar month basis. Nitrogen oxide emissions from the T79 fume incinerators shall not exceed 30 tons per 12-month period, rolled on a calendar month basis.Eli Lilly and Company-Tippecanoe Labs 4 th Significant Permit Modificati on No. 157-22717-00006 Page 184 of 226 Lafayette, Indiana Modified by: Aida De Guzman OP No. T157-6879-00006 Permit Reviewer: Dr. Trip Sinha

(d) Sulfur dioxide (SO 2 ) emissions from the facilities operating under the flexible permit conditions shall not exceed 300 tons per 12-month period, rolled on a calendar month
basis. Sulfur dioxide emissions from the T 79 fume incinerators shall not exceed 5 tons per 12-month period, rolled on a calendar month basis.

(e) Volatile organic compounds (VOC) emissi ons from the facilitie s operating under the flexible permit conditions shall not exce ed 300 tons per 12-month period, rolled on a

calendar month basis.

F.1.2 Site modifications and advance approval of modi fications [326 IAC 2-7-5(9)] [326 IAC 2-7-5(16)]

The Permittee may make modifications described in subsection (a) below to the operations in Sections D.6 through D.15 of this permit. If actual emissions do not exceed the limits in section F.1.1, and the Permittee complies with the other prov isions of this section, then the Permittee is not required to obtain a source modification approv al (otherwise required by 326 IAC 2-7-10.5), a Title V permit modification (otherwise required by 326 IAC 2-7-12), or a Prevention of Significant Deterioration permit (otherwise required by 326 IAC 2-2).

(a) Permitted modifications

The Permittee may implement changes, including but not limited to, the following modifications without triggering the administ rative review processes described above:

(1) BPM Process Operations:

(A) A change in bulk pharmaceutical products or intermediate products manufactured; (B) A change in raw materials stored and utilized; (C) A change in the method of operati on to a process or existing equipment; (D) Piping changes, including but not lim ited to, process piping, waste piping and fume transport piping; (E) A physical change to existing equipment; (F) Reconstruction or replacement of existing equipment, including but not limited to, process tanks, crystallizer s, distillation operations, filters, centrifuges, and dryers; (G) Installation of new equipment, includi ng but not limited to, process tanks, crystallizers, distillation operations, filters, centrifuges, and dryers; (H) Reconstruction or replacement of existing production buildings; and

(2) BPM Support Operations:

(A) A change in solvent material recovered; (B) A change in raw materials stored and utilized; (C) A change in the method of operati on to a process or existing equipment; (D) Piping changes, including but not lim ited to, process piping, waste piping and fume transport piping; (E) A physical change to existing equipment; (F) Reconstruction or replacement of existing equipment, including but not limited to, process tanks, receivers, stills, storage tanks, and container transfer operations; (G) Installation of new equipment, includi ng but not limited to, process tanks, receivers, stills, storage tanks, an d container transfer operations; (H) Reconstruction or replacement of existing solvent recovery operations, storage tanks, storage tank modules, and distillation operations; and

(3) T49 liquid waste incinerator and T149 solids-liquid waste incinerator:

(A) A change in waste materials disposed in the incinerators;Eli Lilly and Company-Tippecanoe Labs 4 th Significant Permit Modificati on No. 157-22717-00006 Page 185 of 226 Lafayette, Indiana Modified by: Aida De Guzman OP No. T157-6879-00006 Permit Reviewer: Dr. Trip Sinha

(B) A change in the use of portable c ontainers, including but not limited to, drums, melons, and tank trailers; (C) A change in the method of operation that does not affect compliance with 40 CFR 63, Subpart EEE; (D) Piping changes; (E) A physical change that does not affect compliance with 40 CFR 63, Subpart EEE; (F) Reconstruction or replacement of incinerator components and support equipment, including but not limited to, cooling towers and waste container management; and (G) Installation of new incinerator equipment components, support equipment or emission control equipment.

(b) Advance approval and applicable requirements

In addition to the emission limits identified in Condition F.1.1 of this permit, the emission limits and standards, compliance demonstrati on requirements, compliance monitoring requirements, record keeping requirements , reporting requirements, and other permit conditions applicable to the type of equipment or operation being modified, replaced, reconstructed or installed are described in Sections D.6 through D.15 of this permit. Each modification will be subject to the relevant provisions of those permit conditions. If a modification would cause an applicable require ment that is not described in this permit to apply, the Permittee must obtain a source modification approval if otherwise required by 326 IAC 2-7-10.5 and a Title V permit modification pursuant to 326 IAC 2-7-12.

Testing and Monitoring Requirements [326 IAC 2-7-6(1) (6)] [326 IAC 2-7-5(1)]

F.1.3 Carbon monoxide (CO) emission limit determination

The Permittee shall determine actual annual emissions by employing the following techniques:

(a) The following requirements apply to the RTOs, the T49 liquid waste incinerator, and the T149 solids-liquid waste incinerator:

(1) CO measurement : The Permittee shall measure CO concentration in the

exhaust of with a CO continuous emission monitoring system (CEMS) that meets the requirements of 40 CFR Part 60, Appendix B and 326 IAC 3.

(2) Flow rate measurement : The Permittee shall measure the actual exhaust gas flow rate from the RTOs and T149 solids-liquid waste incinerator, and measure the combustion and atomized air flow rate into the T49 liquid waste incinerator.

(3) Mass emission calculation : The Permittee shall calculate CO emissions, in tons, each calendar month by using the CEMS data and flow rate data.

(4) Minimum data collection requirements:

(A) For the RTOs, the Permittee shall monitor and record CO concentrations as required in Section D.14.

(B) For the T49 liquid waste incinerator, the Permittee shall monitor and record CO concentrations as required in Section D.12.

(C) For the T149 solids-liquid waste inci nerator, the Permittee shall monitor and record CO concentrations as required in Section D.13.Eli Lilly and Company-Tippecanoe Labs 4 th Significant Permit Modificati on No. 157-22717-00006 Page 186 of 226 Lafayette, Indiana Modified by: Aida De Guzman OP No. T157-6879-00006 Permit Reviewer: Dr. Trip Sinha

(5) Data substitution:

(A) During periods of CEMS calibration, the Permittee shall substitute, in one-minute increments, the last va lid one-minute CO concentration measurement obtained prior to the calibration in lieu of actual readingsfrom the CO CEMS for the RTO and T149 CEMS, and the last valid oneminute CO emission rate measurement obtained prior to the calibration in lieu of actual readings from the CO CEMS for the T49 CEMS.

(B) During periods of flow meter calibration, the Permittee shall substitute, in one-minute increments, the last valid one-minute exhaust gas flow rate measurement obtained prior to the calibration in lieu of actual readings

from the flow meter.

(C) During periods of CEMS maintena nce, malfunction, repair, or other periods of invalid CO data collection, the Permittee shall substitute the following data in lieu of actual readings from the CO CEMS:

(i) When combusting only natural gas, the following CO mass

emission rates shall be substituted:

(1) RTO CO mass emission rate = 0.05 lb/min (2) T49 CO mass emission rate = 0.10 lb/min (3) T149 CO mass emission rate = 0.07 lb/min

(ii) When incinerating a waste stream, the following CO

concentrations shall be substituted:

(1) RTO CO concentration = 73 ppmv (2) T49 CO concentration = 100 ppmv (3) T149 CO concentration = 100 ppmv

(D) During periods of flow meter mainte nance, malfunction, repair, or other periods of invalid exhaust gas flow rate data collection, the Permittee shall substitute the following data in lieu of actual readings from the flow

meter:

(i) When combusting only natural gas, the following CO mass

emission rates shall be substituted:

(1) RTO CO mass emission rate = 0.05 lb/min (2) T49 CO mass emission rate = 0.10 lb/min (3) T149 CO mass emission rate = 0.07 lb/min

(ii) When incinerating a waste st ream, the following exhaust gas

flow rates shall be substituted:

(1) RTO exhaust gas flow rate = 93,000 scfm (2) T49 exhaust gas flow rate = 17,735 dscfm (3) T149 exhaust gas flow rate = 14,340 dscfm

(6) Emissions during RTO bypass periods : When determining compliance with the CO emission limit, the Permittee shall include any known CO emissions from BPM production buildings not emitted through the RTO due to diversions at the fume transport system. The Permittee may use engineering calculation methods based on ideal gas law equations, stoichiome try, or mass balance, to estimate

these emissions.Eli Lilly and Company-Tippecanoe Labs 4 th Significant Permit Modificati on No. 157-22717-00006 Page 187 of 226 Lafayette, Indiana Modified by: Aida De Guzman OP No. T157-6879-00006 Permit Reviewer: Dr. Trip Sinha

(b) The following requirements apply to the T79 fume incinerators (309 and 310):

(1) Natural gas usage : The Permittee shall determine the amount of natural gas burned by the T79 fume incinerators each calendar month.

(2) Emission calculation : The Permittee shall calculate CO emissions, in tons, each calendar month by multiplying the monthly natural gas usage, in mmscf, by

an emission factor of 84 lbs/mmscf and converting the resulting emissions to

tons.

(3) Data substitution : During periods of time when the Permittee is unable to determine natural gas usage because of auditing, calibration, maintenance, malfunction, repair, or other periods when the natural gas meters for the T79 fume incinerators are not collecting valid data, the Permittee shall substitute a natural gas consumption rate for each incinerator of 0.0075 mmscf/hour [based on the nominal heat input rate of 7.626 MMBtu/hr per incinerator].

F.1.4 Fluorides emission limit determination

The Permittee shall determine actual annual emissions by employing the following techniques:

(a) The following requirements apply to the RTOs and the T79 fume incinerators:

(1) Uncontrolled hydrogen fluoride emissions : The Permittee shall determine the mass of fluorine atoms emitted to the RTOs and T79 fume incinerators [as components of fluorinated solvents] by BPM and BPM Support operations, by using engineering calculation methods based on ideal gas law equations, stoichiometry and mass balance. All fluorine atoms shall be considered emitted as hydrogen fluoride (HF) after combus tion in the RTOs or the T79 fume

incinerators.

(2) HF control efficiency: The Permittee shall base fluoride emissions on an RTO and T79 scrubber control efficiency of 98% or a control efficiency determined from an approved stack test. If the compliance monitoring data is not available or indicates the scrubbers are not achieving this control efficiency, the Permittee shall use a control efficiency of zero percent (0%).

(3) Emission calculation : The Permittee shall calculate fluoride emissions, in tons, for each calendar month by multiplying the amount of HF created by combustion of the fluorine atoms in the RTOs and T79 fume incinerators by the respective HF control efficiency.

(4) Emissions during RTO bypass periods : When determining compliance with the fluoride emission limit, the Permittee shall include any known fluoride emissions from BPM production buildings not emitted through the RTO due to diversions at the fume transport system. The Permittee may use engineering calculation methods based on ideal gas law equations, stoichiometry, and mass balance, to estimate these emissions.

(b) The following requirements apply to the T49 liquid waste incinerator and the T149 solidsliquid waste incinerator:

(1) Uncontrolled hydrogen fluoride emissions : When burning liquid wastes, the

Permittee shall determine the mass of fluorine atoms burned in the incinerators by sampling the liquid waste and analyzing the sample for fluorine content, no less frequently than once per quarter. All fluorine atoms shall be considered emitted as hydrogen fluoride (HF). When burning solid wastes in the T149 solids-liquid waste incinerator, the Permittee shall determine monthly HFEli Lilly and Company-Tippecanoe Labs 4 th Significant Permit Modificati on No. 157-22717-00006 Page 188 of 226 Lafayette, Indiana Modified by: Aida De Guzman OP No. T157-6879-00006 Permit Reviewer: Dr. Trip Sinha

emissions by multiplying an emission factor of 0.149 pounds/ton solid waste burned by the monthly solid waste throughput.

(2) HF control efficiency: The Permittee shall base fluoride emissions on an incinerator scrubber control efficiency of 98.0% or a control efficiency determined from an approved stack test. If the compliance monitoring data is not available or indicates the scrubbers are not achieving this control efficiency, the Permittee shall use a control efficiency of zero percent (0%).

(3) Emission calculation : The Permittee shall calculate fluoride emissions, in tons, for each calendar month by multiplying t he amount of uncontrolled HF emissions by the HF control efficiency.

F.1.5 Nitrogen oxides (NO X ) emission limit determination

The Permittee shall determine actual annual emissions by employing the following techniques:

(a) The following requirements apply to the RTOs, the T49 liquid waste incinerator, and the T149 solids-liquid waste incinerator:

(1) NOx measurement : The Permittee shall measure NOx concentration in the

exhaust of with a NOx continuous emi ssion monitoring system (CEMS) in accordance with the requirements of 40 CFR Part 60, Appendix B and 326 IAC 3.

(2) Flow rate measurement : The Permittee shall measure the actual exhaust gas flow rate from the RTOs and T149 solids-liquid waste incinerator, and measure the combustion and atomized air flow rate into the T49 liquid waste incinerator with a system.

(3) Emission calculation : The Permittee shall calculate NOx emissions, in tons, each calendar month by using the CEMS data and flow rate data.

(4) Data substitution:

(A) During periods of CEMS calibration, the Permittee shall substitute, in one-minute increments, the last valid one-minute NOx concentration measurement obtained prior to the calibration in lieu of actual readings from the NOx CEMS for the RTO and T149 CEMS, and the last valid

one-minute NOx emission rate meas urement obtained prior to the calibration in lieu of actual readings from the NOx CEMS for the T49

CEMS.

(B) During periods of flow meter calibration, the Permittee shall substitute, in one-minute increments, the last valid one-minute exhaust gas flow rate measurement obtained prior to the calibration in lieu of actual readings

from the flow meter.

(C) During periods of CEMS maintena nce, malfunction, repair, or other periods of invalid NOx data collection, the Permittee shall substitute the following data in lieu of actual readings from the NOx CEMS:

(i) When combusting only natural gas, the following NOx mass

emission rates shall be substituted:

(1) RTO NOx mass emission rate = 0.03 lb/min (2) T49 NOx mass emission rate = 0.12 lb/min (3) T149 NOx mass emission rate = 0.08 lb/minEli Lilly and Company-Tippecanoe Labs 4 th Significant Permit Modificati on No. 157-22717-00006 Page 189 of 226 Lafayette, Indiana Modified by: Aida De Guzman OP No. T157-6879-00006 Permit Reviewer: Dr. Trip Sinha

(ii) When incinerating a waste stream, the following NOx

concentrations shall be substituted:

(1) RTO NOx concentration = 91 ppmv (2) T49 NOx concentration = 975 ppmvdc (3) T149 NOx concentration = 170 ppmvdc

(D) During periods of flow meter mainte nance, malfunction, repair, or other periods of invalid exhaust gas flow rate data collection, the Permittee shall substitute the following data in lieu of actual readings from the flow

meter:

(i) When combusting only natural gas, the following NOx mass

emission rates shall be substituted:

(1) RTO NOx mass emission rate = 0.03 lb/min (2) T49 NOx mass emission rate = 0.12 lb/min (3) T149 NOx mass emission rate = 0.08 lb/min

(ii) When incinerating a waste st ream, the following exhaust gas

flow rates shall be substituted:

(1) RTO exhaust gas flow rate = 93,000 scfm (2) T49 exhaust gas flow rate = 17,735 dscfm (3) T149 exhaust gas flow rate = 14,340 dscfm

(5) Minimum data collection requirements:

(A) For the RTOs, the Permittee shall monitor and record NOx concentrations as required in Section D.14. (B) For the T49 liquid waste incinerator, the Permittee shall monitor and record NOx concentrations as required in Condition D.12. (C) For the T149 solids-liquid waste inci nerator, the Permittee shall monitor and record NOx concentrations as required in Section D.13.

(6) Emissions during RTO bypass periods : When determining compliance with the NOx emission limit, the Permittee shall include any known NOx emissions from BPM production buildings or storage tank modules not emitted through the RTO due to diversions in the fume transport system. The Permittee may use engineering calculation methods based on ideal gas law equations, stoichiometry, or mass balance to estimate these emissions.

(b) The following requirements apply to the T79 Fume Incinerators:

(1) NOx emission calculation for natural gas usage: The Permittee shall determine the amount of natural gas burned by the T79 Fume Incinerators each calendar month. The Permittee shall calculate NOx emissions from natural gas combustion, in tons, each calendar month by multiplying the monthly natural gas usage by an emission factor of 50 lbs/mmscf and converting the resulting

emissions to tons.

(2) NOx emission calculation for combus tion of nitrogen-containing solvents : The Permittee shall determine the mass of nitrogen atoms emitted to the T79 fume incinerators [as components of solvents containing nitrogen] by the BPM Support operations by using engineerin g calculations based on ideal gas law equations, stoichiometry, or mass balance. Six (6%) of the nitrogen atoms shall be considered emitted as nitrogen oxides after combustion in the T79 fume

incinerators.Eli Lilly and Company-Tippecanoe Labs 4 th Significant Permit Modificati on No. 157-22717-00006 Page 190 of 226 Lafayette, Indiana Modified by: Aida De Guzman OP No. T157-6879-00006 Permit Reviewer: Dr. Trip Sinha

(3) Data substitution: During periods of time when the Permittee is unable to determine natural gas usage because of auditing, calibration, maintenance, malfunction, repair, or other periods when the natural gas meters for the T79 fume incinerators are not collecting valid data, the Permittee shall determine NOx emissions based on a natural gas co nsumption rate of 0.0075 mmscf/hour [based on the nominal heat input rate of 7.626 MMBtu/hr per incinerator].

F.1.6 Sulfur dioxide (SO 2 ) emission limit determination

The Permittee shall determine actual annual emissions by employing the following techniques:

(a) The following requirements apply to RTOs, the T49 liquid waste incinerator, and the T149 solids-liquid waste incinerator:

(1) SO 2 measurement : The Permittee shall measure SO 2 concentration in the exhaust of RTO, and incinerators with a SO 2 continuous emission monitoring system (CEMS) that meets the require ments of 40 CFR Part 60, Appendix B and

326 IAC 3.

(2) Flow rate measurement : The Permittee shall measure the actual exhaust gas flow rate from the RTOs and the T149 solids-liquid waste incinerator, and

measure the combustion and atomized air flow rate into the T49 liquid waste

incinerator.

(3) Emission calculation : The Permittee shall calculate SO 2 emissions, in tons, each calendar month by using the CEMS data and flow rate data.

(4) Data substitution:

(A) During periods of CEMS calibration, the Permittee shall substitute, in one-minute increments, the last valid one-minute SO 2 concentration measurement obtained prior to the calibration in lieu of actual readings
from the SO 2 CEMS for the RTO and T149 CEMS, and the last valid

one-minute SO 2 emission rate measurement obtained prior to the calibration in lieu of actual readings from the SO 2 CEMS for the T49

CEMS.

(B) During periods of flow meter calibration, the Permittee shall substitute, in one-minute increments, the last valid one-minute exhaust gas flow rate measurement obtained prior to the calibration in lieu of actual readings

from the flow meter.

(C) During periods of CEMS maintena nce, malfunction, repair, or other periods of invalid SO 2 data collection, the Permittee shall substitute the following data in lieu of actual readings from the SO 2 CEMS:

(i) When combusting only natural gas, the following SO 2 mass emission rates shall be substituted:

(1) RTO SO 2 mass emission rate = 0.0004 lb/min (2) T49 SO 2 mass emission rate = 0.0007 lb/min (3) T149 SO 2 mass emission rate = 0.0005 lb/min

(ii) When incinerating a waste stream, the following SO 2 concentrations shall be substituted:

(1) RTO SO 2 concentration = 100 ppmv (2) T49 SO 2 Concentration = 500 ppmv (3) T149 SO 2 concentration = 400 ppmvEli Lilly and Company-Tippecanoe Labs 4 th Significant Permit Modificati on No. 157-22717-00006 Page 191 of 226 Lafayette, Indiana Modified by: Aida De Guzman OP No. T157-6879-00006 Permit Reviewer: Dr. Trip Sinha

(D) During periods of flow meter mainte nance, malfunction, repair, or other periods of invalid exhaust gas flow rate data collection, the Permittee shall substitute the following data in lieu of actual readings from the flow

meter:

(i) When combusting only natural gas, the following SO 2 mass emission rates shall be substituted:

(1) RTO SO 2 mass emission rate = 0.0004 lb/min (2) T49 SO 2 mass emission rate = 0.0007 lb/min (3) T149 SO 2 mass emission rate = 0.0005 lb/min

(ii) When incinerating a waste st ream, the following exhaust gas

flow rates shall be substituted:

(1) RTO exhaust gas flow rate = 93,000 scfm (2) T49 exhaust gas flow rate = 17,735 dscfm (3) T149 exhaust gas flow rate = 14,340 dscfm

(5) Minimum data collection requirements:

(A) For the RTOs, the Permittee shall monitor and record SO 2 concentrations as required in Section D.14. (B) For the T49 liquid waste incinerator, the Permittee shall monitor and

record SO 2 concentrations as required in Condition D.12. (C) For the T149 solids-liquid waste inci nerator, the Permittee shall monitor
and record SO 2 concentrations as required in Condition D.13.

(6) Emissions during RTO bypass periods: When determining compliance with
the SO 2 emission limit, the Permittee shall include any known SO 2 emissions from BPM production buildings and storage tank modules not emitted through the RTO due to diversions in the fume transport system. The Permittee may use engineering calculation methods based on ideal gas law equations, stoichiometry, or mass balance to estimate these emissions.

(b) The following requirements apply to the T79 fume incinerators:

(1) SO 2 emission calculation for natural gas usage: The Permittee shall determine the amount of natural gas burned by the T79 fume incinerators each
calendar month. The Permittee shall calculate SO 2 emissions from natural gas combustion, in tons, each calendar month by multiplying the monthly natural gas usage by an emission factor of 0.6 lbs/mmscf and converting the resulting

emissions to tons.

(2) Uncontrolled SO 2 emission calculation for combustion of sulfur-containing

solvents: The Permittee shall determine the ma ss of sulfur atoms emitted to the T79 fume incinerators [as components of solvents containing sulfur] by the BPM Support operations by using engineering calculation methods based on ideal gas law equations, stoichiometry, or mass balanc e. All of the sulfur atoms shall be
considered converted to SO 2 as a result of combustion in the T79 fume

incinerators.

(3) SO 2 control efficiency: The Permittee shall base SO 2 emissions on T79 scrubber control efficiency of 95%. If the compliance monitoring data is not

available or indicates the scrubbers are not achieving this control efficiency, the Permittee shall use a control efficiency of zero percent (0%).Eli Lilly and Company-Tippecanoe Labs 4 th Significant Permit Modificati on No. 157-22717-00006 Page 192 of 226 Lafayette, Indiana Modified by: Aida De Guzman OP No. T157-6879-00006 Permit Reviewer: Dr. Trip Sinha

(4) Emission calculation: The Permittee shall calculate SO 2 emissions, in tons, each calendar month by multiplying the amount of SO 2 created by combustion of the sulfur atoms in the T79 fume incinerators by the scrubber SO 2 control efficiency.

(5) Data substitution: During periods of time when the Permittee is unable to determine natural gas usage because of auditing, calibration, maintenance, malfunction, repair, or other periods when the natural gas meters for the T79 fume incinerators are not collecting data properly, the Permittee shall determine
SO 2 emissions based on a natural gas consumption rate of 0.0075 mmscf/hour [based on the nominal heat input rate of 7.626 MMBtu/hr per incinerator].

F.1.7 Volatile organic compound (V OC) emission limit determination

The Permittee shall determine actual annual emissions by employing the following techniques:

(a) The following requirements apply to the RTOs when compliance is based on the 20 ppmv alternative standard, the T49 liquid waste in cinerator, and the T149 solids-liquid waste

incinerator:

(1) VOC measurement:

(A) For the RTO operations, the Perm ittee shall directly measure TOC concentration, as methane

, in the exhaust gas using a TOC continuous emission monitoring system (CEMS) that meets the requirements of 40 CFR Part 63. The Permittee shall assume VOC, a subset of total organic compounds (TOC), is equal to TOC.

(B) For the T49 liquid waste incinerator and the T149 solids-liquid waste incinerator, the Permittee shall use 10 ppmdvc methane or shall use the highest hourly rolling average HC level achieved during the DRE test runs as the TOC concentration in the exhaust gas, as long as the CO concentration, as measured by the CO CEMS, is less than 100 ppmvdc, averaged over a rolling hourly period. VOC, a subset of total organic compounds (TOC), shall be equal to TOC.

(2) Flow rate measurement: The Permittee shall measure the actual exhaust gas flow rate from the RTOs and the T149 solids-liquid waste incinerator, and

measure the combustion and atomized air flow rate into the T49 liquid waste

incinerator.

(3) Emission calculation : The Permittee shall calculate VOC emissions, in tons, each calendar month by using the TOC CEMS concentration data, measured as methane (MW = 16), and exhaust gas flow rate data.

(4) Data substitution:

(A) During periods of CEMS calibration, the Permittee shall substitute, in one-minute increments, the last valid one-minute TOC/CO concentration measurement obtained prior to the calibration in lieu of actual readings
from the TOC/CO CEMS.

(B) During periods of flow meter calibration, the Permittee shall substitute, in one-minute increments, the last valid one-minute exhaust gas flow rate measurement obtained prior to the calibration in lieu of actual readings

from the flow meter.Eli Lilly and Company-Tippecanoe Labs 4 th Significant Permit Modificati on No. 157-22717-00006 Page 193 of 226 Lafayette, Indiana Modified by: Aida De Guzman OP No. T157-6879-00006 Permit Reviewer: Dr. Trip Sinha

(C) During periods of CEMS maintena nce, malfunction, repair, or other periods of invalid TOC/CO data collection, the Permittee shall substitute the following data in lieu of actual readings from the TOC/CO CEMS:

(i) When combusting only natural gas, the following VOC mass

emission rates shall be substituted:

(1) RTO VOC mass emission rate = 0.003 lb/min (2) T49 VOC mass emission rate = 0.007 lb/min (3) T149 VOC mass emission rate = 0.004 lb/min

(ii) When incinerating a waste stream, the following TOC

concentrations shall be substituted:

(1) RTO TOC concentration = 20 ppmv methane (2) T49 TOC concentration = 10 ppmv methane (3) T149 TOC concentration = 10 ppmv methane

(D) During periods of flow meter mainte nance, malfunction, repair, or other periods of invalid exhaust gas flow rate data collection, the Permittee shall substitute the following data in lieu of actual readings from the flow

meter:

(i) When combusting only natural gas, the following VOC mass

emission rates shall be substituted:

(1) RTO VOC mass emission rate = 0.003 lb/min (2) T49 VOC mass emission rate = 0.007 lb/min (3) T149 VOC mass emission rate = 0.004 lb/min

(ii) When incinerating a waste st ream, the following exhaust gas

flow rates shall be substituted:

(1) RTO exhaust gas flow rate = 93,000 scfm (2) T49 exhaust gas flow rate = 17,735 dscfm (3) T149 exhaust gas flow rate = 14,340 dscfm

(5) Minimum data collection requirements:

(A) For the RTOs, the Permittee shall monitor and record VOC concentrations as required in condition D.14.

(B) For the T49 liquid waste incinerator, the Permittee shall monitor and record VOC concentrations as required in condition D.12.

(C) For the T149 solids-liquid waste inci nerator, the Permittee shall monitor and record VOC concentrations as required in D.13.

(6) Emissions during RTO bypass periods: The Permittee shall include any known VOC emissions from BPM production buildings not emitted through the RTO due to diversions in the fume transport system. The Permittee may use engineering calculation methods based on ideal gas law equations, stoichiometry, or mass balance to estimate these emissions.

(b) The following requirements apply to the RTOs when compliance is based on the 98% control efficiency standard and the T79 fume incinerators:

(1) VOC emission calculation for natural gas usage: The Permittee shall determine the amount of natural gas burned by the RTOs and the T79 fumeEli Lilly and Company-Tippecanoe Labs 4 th Significant Permit Modificati on No. 157-22717-00006 Page 194 of 226 Lafayette, Indiana Modified by: Aida De Guzman OP No. T157-6879-00006 Permit Reviewer: Dr. Trip Sinha

incinerators each calendar month. The Permittee shall calculate VOC emissions from natural gas combustion, in tons, each calendar month by multiplying the monthly natural gas usage by an emission factor of 5.5 lbs/mmscf and converting the resulting emissions to tons.

(2) VOC emission calculation from BPM production operations and BPM support operations exhausting to the RTOs and the T79 fume incinerator system: The Permittee shall estimate the uncontrolled VOC emissions from the BPM production operations and the BPM support operations exhausting to the RTOs and the T79 fume incinerator system by using engineering calculation methods based on ideal gas law equations, stoichiometry, or mass balance. The
Permittee shall base VOC emissions on an RTO and T79 fume incinerator control efficiency of 98%. If the complia nce monitoring data is not available or indicates the RTO or T79 fume incinerator is not achieving this control efficiency, the Permittee shall use a control efficiency of zero percent (0%).

(3) Data substitution: During periods of time when the Permittee is unable to determine natural gas usage because of auditing, calibration, maintenance, malfunction, repair, or other periods when the natural gas meters for the RTOs or T79 fume incinerator system are not collecting valid data, the Permittee may assume that natural gas is consumed at a rate of 0.0075 mmscf/hour [based on the nominal heat input rate of 7.626 MMBtu/hr per incinerator].

(c) Fugitive VOC emissions from BPM and BPM Support Operations, including the Chemical

Wastewater Treatment Plant : The Permittee shall determine monthly fugitive VOC emissions using the following calculation methods:

(1) Emission factors: The Permittee shall develop em ission factors to calculate monthly fugitive VOC emissions. The emission factors shall be developed according to the following methods.

(A) For each VOC compound that the Pe rmittee reports release of in the annual SARA Title III TRI report (“reportable SARA VOCs”), the Permittee shall develop a compound-spec ific emission factor, expressed in pounds of emissions per 100 pound s of solvent usage. Reportable
SARA VOC emission factors shall be derived from mass-balance data used to submit SARA reports. Each compound-specific fugitive emission factor for reportable SARA VOCs shall be updated and applied to monthly fugitive emission calculations beginning July 1 of each year.

(B) For VOC compounds not reported under SARA Title III, the Permittee shall use a generic fugitive emissi on factor, expressed in pounds of emissions per 100 pounds of solvent usage. The generic fugitive emission factor shall be equal to the highest representative emission factor developed in (A) above for a reportable SARA VOC used as a raw material in production processes. In the alternative, the Permittee may develop and apply a compound-specific emission factor for a compound not reported under SARA Title III. T he generic fugitive emission factor and any compound-specific fugitive emission factor shall be updated and applied to monthly fugitive emission calculations beginning July 1 of each

year.

(2) Emission calculation method: For VOCs with a compound-specific emission factor described in (1), the Permitt ee shall calculate monthly fugitive VOC emissions by multiplying the compoun d-specific emission factor by the corresponding compound-specific monthl y solvent usage. For VOCs without a compound-specific emission factor, the Pe rmittee shall calculate monthly fugitive VOC emissions by multiplying the generic em ission factor described in (1)(B) by the monthly solvent usage of those compounds.Eli Lilly and Company-Tippecanoe Labs 4 th Significant Permit Modificati on No. 157-22717-00006 Page 195 of 226 Lafayette, Indiana Modified by: Aida De Guzman OP No. T157-6879-00006 Permit Reviewer: Dr. Trip Sinha

Record keeping and reporting [326 IAC 2-7-5(3)] [326 IAC 2-7-19]

F.1.8 Records and reporting emission lim its [326 IAC 2-7-5(3)] [326 IAC 2-7-19]

(a) The Permittee shall record and maintain records of all information including all

measurements and calculations described in Sections F.1.3 through F.1.7.

(b) The Permittee shall submit a quarterly report of actual emissions of CO, fluorides, NOx,

SO 2 , and VOC, as determined in accordance with Sections F.1.4 through F.1.8, to the address listed in Section C – General Reporti ng Requirements, within thirty (30) days after the end of the calendar quarter being report ed. This report requires the certification by the “responsible official” as defined by 326 IAC 2-7-1(34).

F.1.9 Change managemen t evaluation process

For purposes of the requirements of the Pharma ceutical MACT standards [40 CFR 63, Subpart GGG], the Permittee shall employ a change ma nagement evaluation process to determine whether changes will affect compliance. This change evaluation process shall include the following elements:

(a) New processes, process changes, and phy sical changes to process equipment that increase hazardous air pollutant emissions fr om process vents, wastewater streams, and storage tanks will be consider ed “new process operating scenarios”. Changes which affect fugitive emissions equipment com ponents will not be considered new operating scenarios and will be managed per the relevant provisions of the leak detection and repair program, which includes provisions addressing the addition of, and changes to, components.

(b) Each new process operatin g scenario [as defined in F. 1.10 (a)] will be reviewed to determine whether the change will affect comp liance with the emission standards under the Pharmaceutical MACT requirements. Co mpliance with the following standards will be evaluated: process vent standa rds [40 CFR 63.1254]; storage tank standards [40 CFR 63.1253]; and wastewater streams [40 CFR 63.1256].

(c) Documentation of t he evaluation of each new process operating scenario will contain the following information:

(1) For new or changed process vents, a statement regarding the method for complying with 40 CFR 63.1254. The stat ement shall include an analysis that shows whether the new or changed pr ocess vents fit within an existing compliance demonstration, or whether another demonstration must be

conducted.

(2) For new or changed storage tanks, a statement regarding the method for complying with 40 CFR 63.1253. The stat ement shall include an analysis that shows whether the new or changed storage tank fits within an existing compliance demonstration, or whether another demonstration must be

conducted.

(3) For new or changed wastewater stream s, a statement regarding the method for complying with 40 CFR 63.1256. The stat ement shall include an analysis that shows whether the new or changed wastew ater stream fits within an existing compliance demonstration, or whether another demonstration must be

conducted.

(d) If a new process-operating scenario will trigger applicable requirements not described in this permit or compliance with applicable requirements will be demonstrated byEli Lilly and Company-Tippecanoe Labs 4 th Significant Permit Modificati on No. 157-22717-00006 Page 196 of 226 Lafayette, Indiana Modified by: Aida De Guzman OP No. T157-6879-00006 Permit Reviewer: Dr. Trip Sinha

methodologies not described in this permit, this permit must be revised pursuant to 326
IAC 2-7-12.

F.1.10 Records and reporting of site modification s [326 IAC 2-7-5(16)] [326 IAC 2-7-20(a)] [40 CFR 63.1259] [40 CFR 63.1260]

(a) Changes made pursuant to advance approval provisions:

The Permittee shall record and maintain records of all modifications that would have otherwise required a revision to this permi t pursuant to 326 IAC 2-7-12 or a source modification approval if the provisions of 326 IAC 2-7-10.5 were applicable.

(b) Pharmaceutical MACT operating scenarios:

(1) Pursuant to 40 CFR 63.1259(c), for all equipment subject to the pharmaceutical MACT requirements, the Permittee sha ll develop a record describing operating scenarios that may occur in the BPM operations and BPM Support operations.

(2) Pursuant to 40 CFR 63.1259(f)(4), for all equipment subject to the pharmaceutical MACT requirements, the Pe rmittee shall list all known operating scenarios that may occur in the BPM operations and BPM Support operations in the notification of compliance status report.

(3) Pursuant to 40 CFR 63.1259(b)(8), for all equipment subject to the pharmaceutical MACT requirements, the Permittee shall maintain a log that records, which operating scenarios have been, put into effect in the BPM operations and BPM Support operations.

F.1.11 Notifications for site modi fications [326 IAC 2-1.1-12(e)-(f)]

(a) The Permittee shall submit a notification for any modification that would have otherwise required a source modification approval if the provisions of 326 IAC 2-7-10.5 were applicable, to the address listed in Section C – General Reporting Requirements, at least ten (10) days before implementing the modification.

(b) The notification shall include the following information:

(1) the company name and address and source and permit identification numbers;

(2) a description of the physical or operational change, including an estimate of the potential to emit of the emissi ons associated with the change;

(3) an identification of the emission uni t or units being changed on the layout diagram of the source;

(4) the schedule for constructing each physical change and implementing each operational change;

(5) identification of any applicable requirem ents that are applicable to the physical or operational change and include any monitori ng, record keeping, or reporting requirements to assure compliance with the applicable requirements;

(6) a statement for all regulated pollutant s, except the pollutant for which the emissions limit has been established, t hat demonstrates that the physical or operational change will not trigger any feder al or state permitting requirement for any regulated pollutant; andEli Lilly and Company-Tippecanoe Labs 4 th Significant Permit Modificati on No. 157-22717-00006 Page 197 of 226 Lafayette, Indiana Modified by: Aida De Guzman OP No. T157-6879-00006 Permit Reviewer: Dr. Trip Sinha

(7) a statement that the physical or operat ional change will not result in emissions greater than the emissions limit.

(c) This notification does not r equire the certification by the “responsible official” as defined by 326 IAC 2-7-1(34).

F.1.12 Inclusion of site modifications in Pharmaceutical MACT Periodic Report

(a) Pursuant to 40 CFR 63.1260(g)(2)(vii), the Pe rmittee shall include in the Periodic Report information for each new operating scenario operated since the time period covered by the last periodic report. These reports shall be submitted as required in Conditions D.14.9 or D.15.8 – Reporting Requirements.

(b) Pursuant to 40 CFR 63.1260(h)(1), whenever a new process is introduced, or a change in any of the information submitted in the Notification of Compliance Status Report, the Permittee shall submit the following informati on with the next Periodic report as required in Conditions D.14.9 or D.15.8 – Reporting Requirements:

(1) A brief description of the process change;

(2) A description of any modifications to standard procedures or quality assurance procedures;

(3) Revisions to any of the information reported in the original Notification of Compliance Status Report under pa ragraph (f) of this section; and

(4) Information required by the Notifica tion of Compliance Status Report under paragraph (f) of this section for change s involving the addition of processes or equipment.

(c) Pursuant to 40 CFR 63.1260(h)(2), the Pe rmittee must submit a report 60 days before the scheduled implementation date of either of the following:

(1) Any change in the activity cove red by the Precompliance report.

(2) A change in the status of a control device from small to large.

F.1.13 Reports of changes affected by Hazardous Waste Combustor MACT

(a) Pursuant to 40 CFR 63.1206(b)(5)(iii), a change is defined as any change in design, operation or maintenance practices that were documented in the comprehensive performance test plan, Notification of Complia nce, or startup, shutdown, and malfunction plan.

(b) For changes that may adversely affect co mpliance which are not monitored with a CEMS,

the Permittee shall:

(1) Notify the Administrator at least 60 days prior to the change, unless

circumstances are documented that dict ate that such prior notice is not reasonably feasible.

(2) Conduct a comprehensive performance test under the requirements of 40 CFR 63.1207(f)(1) and (g)(1) to document co mpliance with the affected emission standard(s) and establish operating parameter limits as required under 40 CFR 63.1209, and submit the Administrator a Notification of Compliance under 40 CFR 63.1207(j) and 40 CFR 63.1210(d); andEli Lilly and Company-Tippecanoe Labs 4 th Significant Permit Modificati on No. 157-22717-00006 Page 198 of 226 Lafayette, Indiana Modified by: Aida De Guzman OP No. T157-6879-00006 Permit Reviewer: Dr. Trip Sinha

(3) Not burn hazardous waste for more than a total of 720 hours after such change is made and prior to submitting the not ification of compliance unless the Administrator provides a written approval to burn hazardous waste in the interim.

(c) For changes that will not affect compliance, the Permittee shall document the change in the operating record upon making such change. The Permittee shall revise as necessary the performance test plan, Documentation of Compliance, Notification of Compliance, and startup, shutdown and malfunction plan to reflect these changes.

Other flexible permit requirements

F.1.14 Valid period for Best Available Control Technology [326 IAC 2-2-3(4)]

The modifications that occur under this permit qualify as a single, ongoing phase of construction and modification to Tippecanoe Laboratories. The BACT requirements established in Sections D.6 through D.15 shall remain valid over the ent ire period of this permit. If the time between consecutive modifications exceeds 18 months, t he Permittee shall demonstrate that the initial BACT determination incorporated into the permit is still valid or propose new BACT requirements. The Permittee shall also provide, in its applicati on for renewal of the permit, that the initial BACT determination incorporated into the permit is st ill valid or propose new BACT requirements. Upon expiration of this permit, Major New Source Re view requirements (Prevention of Significant Deterioration and Nonattainment NSR) shall apply.

F.1.15 Emission increases from increased utilization of ancillary equipment [326 IAC 2-2] (Deleted)

Condition F.1.15 was deleted pursuant to Administrative Permit Amendment 157-20003-00006.

F.1.16 NSPS and NESHAP pre-construc tion notification and reviews

The provisions of this permit do not relieve the Permittee of the notificat ion and pre-construction approval requirements found in 40 CFR 60.7, 40 CFR 61.07, 40 CFR 61.08, and 40 CFR 63.5. If the Permittee constructs, reconstructs, or modifies an affected facility in a manner that requires notification or pre-construction approval under 40 CFR 60.7, 40 CFR 61.07, 40 CFR 61.08, or 40 CFR 63.5, the Permittee shall comply with those requirements.

F.1.17 Pollution Prevention Program

The Permittee shall implement a pollution prevention program as described below:

(a) The Permittee shall develop a pollution prev ention strategy that describes the site's

involvement and efforts to reduce the use of raw materials and reduce waste and emissions generation. The plan shall be available to IDEM upon request.

(b) The Permittee shall communicate its pollution prevention strategy to the public by conducting public outreach meetings.

Tippecanoe Laboratories will submit an annual r eport to IDEM describing specific pollution prevention efforts that took place during the calend ar year. The report shall include an estimate of the air emission, wastewater, and waste reductions prevented or achieved by pollution prevention activities.Eli Lilly and Company-Tippecanoe Labs 4 th Significant Permit Modificati on No. 157-22717-00006 Page 199 of 226 Lafayette, Indiana Modified by: Aida De Guzman OP No. T157-6879-00006 Permit Reviewer: Dr. Trip Sinha

SECTION G.1 Plantwide Applicab ility Limitations Requirements

Facility description [326 IAC 2-7-5(15)]

The information described in the following paragraphs is descriptive information and does not constitute

enforceable conditions:

The entire plant site is subject to the plantw ide applicability limitations [PAL] requirements
described in this G section.

Source wide emission limits [326 IAC 2-2.4-7(1)]

G.1.1 Emission limits [326 IAC 2-2.4-7(1)]

(a) Nitrogen oxides (NOx) emissions from the entire source shall not exceed 648 tons per 12 consecutive month period with compliance det ermined at the end of each month. This provision does not supersede any other NOx emission limits contained in this permit.

(b) Sulfur dioxide (SO 2 ) emissions from the entire source shall not exceed 2059 tons per 12- consecutive month period, with compliance determined at the end of each month. This provision does not supersede any other SO 2 emission limits contained in this permit.

General PAL requirements [326 IAC 2-2.4-1]

G.1.2 Major New Source Review Applicability [326 IAC 2-2.4-1(c)]

Any physical change in or change in the method of operation of this source is not a major
modification for NOx or SO 2 , and not subject to the review re quirements of 326 IAC 2-2 provided

the actual emissions of NOx and SO 2 from the entire source do not exceed the emission limits in Condition G.1.1 of this permit. This provision do es not supersede or affect the Flexible Permit requirements in Section F of this permit.

G.1.3 General PAL requirements [326 IAC 2-2.4-7, 326 IAC 2-2.4-8, 326 IAC 2-2.4-9, 326 IAC 2-2.4-10, 326 IAC 2-2.4-11, 326 IAC 2-2.4-15]

(a) The requirements of this section G become effective on the issuance date of the PAL permit, and expire ten years after t he issuance date of the PAL permit.

(b) If the Permittee applies to renew this PAL at least six months prior to expiration of the PAL, but no earlier than eighteen months prior to the expiration of the PAL, then notwithstanding the expiration date in subsecti on G.1.3(a), the PAL shall continue to be effective until the revised permit with the r enewed PAL is issued. The application must

contain the elements described in 32 6 IAC 2-2.4-3 and 326 IAC 2-2.4-10.

(c) Once this PAL expires, if not otherwise renewed, then the requi rements of 326 IAC 2-2.4- 9 are applicable.

(d) The requirements for renewing this PAL are described in 326 IAC 2-2.4-10.

(e) The requirements for increasing the emi ssions limits described in Condition G.1.1 are

described in 326 IAC 2-2.4-11.

(f) The requirements applicable to terminating or revoking this PAL are described in 326 IAC

2-2.4-15.Eli Lilly and Company-Tippecanoe Labs 4 th Significant Permit Modificati on No. 157-22717-00006 Page 200 of 226 Lafayette, Indiana Modified by: Aida De Guzman OP No. T157-6879-00006 Permit Reviewer: Dr. Trip Sinha

Testing and Monitoring Requirements [326 IAC 2-2.4-7(6) & (7)] [326 IAC 2-2.4-12]

G.1.4 Nitrogen Oxides (NO X ) Emission Limit Determination [326 IAC 2-2.4-7(6) & (7)] [326 IAC 2-2.4-12]

The Permittee shall determine actual annual emissions of NOx by employing the following techniques:

(a) The Permittee shall calculate NOx emissions from Boilers 1, 2, and 3, in tons, each calendar month, by multiplying the amount of coal consumed in each calendar month by a NOx

emission factor of 16 lb NOx/ton of coal burned. After the coal feed to Boilers No. 1, No. 2, and No. 3 is shutdown, or starting September 14, 2007, whichever comes first, the NOx

emissions from these boilers shall be calcul ated using an emission factor of 100 lbs NOx/million cubic feet of natural gas burned.

(b) The Permittee shall calculate NOx emissions from burning natural gas in Boilers 4 and 5, in tons, each calendar month, by multiplyi ng the amount of natural gas burned in each calendar month by an NOx emission factor of 280 lb NOx/million cubic feet of natural gas burned in Boiler 4 and 100 lb NOx/million cubic feet of natural gas burned in Boiler 5.

(c) The Permittee shall calculate NOx emissions from burning fuel oil in Boilers 4 and 5, in tons, each calendar month, by multiplying t he amount of fuel oil burned in each calendar month by an NOx emission factor of 24 lb NOx/1000 gallons of fuel oil burned in Boiler 4 and 20 lb NOx/1000 gallons of fuel oil burned in Boiler 5.

(d) The Permittee shall determine NOx emissions from diesel engines, in tons, each calendar month, through one of the methods described in (1) and (2) below. The Permittee shall identify which method it used when it reports emissions pursuant to
Condition G.1.8.

(1) Potential to emit method : The Permittee shall use the following values, which represent the NOx potential to emit of the diesel engines, as the actual

emissions:

(A) For the T121 1250 KW diesel electrical generator – 1.5 ton/month [18.1 ton/yr].

(B) For the T5 380 HP diesel emergency generator – 0.2 ton/month [2.9 ton/yr]

(C) For the T62 1100 KW diesel emer gency generator – 0.7 ton/month [8.9 ton/yr].

(D) For the T135 390 HP diesel emergency generator – 0.3 ton/month [3.0 ton/yr].

(E) For the T78 58 KW diesel compressor engine – 0.9 ton/month [10.6 ton/yr]

(F) For the T89-1 KW diesel compre ssor engine – 0.9 ton/month [10.6 ton/yr].

(G) For the T89-2 KW diesel compre ssor engine – 0.9 ton/month [10.6 ton/yr].

(2) Actual hours of operation method: The Permittee shall calculate NOx emissions from diesel engines by multip lying the actual hours of operation per calendar month for each diesel engine by the engine’s horsepower rating and by an NOx emission factor of 0.024 lb NOx/brake horsepower-hour for dieselEli Lilly and Company-Tippecanoe Labs 4 th Significant Permit Modificati on No. 157-22717-00006 Page 201 of 226 Lafayette, Indiana Modified by: Aida De Guzman OP No. T157-6879-00006 Permit Reviewer: Dr. Trip Sinha

engines greater than 600 brake horse power and 0.031 lb NOx/brake horsepower-hour for diesel engines smaller than 600 brake horse power

(e) The Permittee shall calculate NOx emissions from the T174 Thermal Research Incinerator, in tons, each calendar month, by multiplying the actual hours of operation of the incinerator for each month by a NOx emissi on factor of 2.5 lb NOx/hour of operation.

(f) The methods for determining monthly NOx em issions from the T49 Incinerator, the T149 Incinerator, the RTOs, and the T79 Fume Incine rators are described in Condition F.1.5 of this permit.

(g) NOx emissions from the T71 Pilot Plant are equivalent to the potential to emit for this facility – 0.1 ton/yr.

(h) When determining actual annual emissions of NOx, the Permittee shall include emissions occurring as a result of startups, shutdown, and malfunctions.

(i) The Permittee shall determine NOx emissions from boilers No. 6 and No. 7, in tons, each calendar month, using CEMS data from Condition D.20.16 and using the following

method to determine NOx emission limits in Co ndition D.20.4: NOx emissions in lbs = lbs NOx/MMBTU * fuel usage( scf for natural gas, and gallons for fuel oil) * Heat content per
unit of fuel used. A value of 1000 BTU/scf of natural gas shall be used if heat content data for the natural gas is unavailable. If dat a is not available for calculating the NOx emissions, the following substitution value sha ll be used: 32.0 lbs NOx/Hour. This value represents the maximum potential emissions of each boiler.

G.1.5 Sulfur dioxides (SO 2 ) emission limit determination [326 IAC 2-2.4-7(6) & (7)] [326 IAC 2-2.4-12]

The Permittee shall determine actual annual emissions of SO 2 by employing the following techniques:

(a) The Permittee shall calculate SO 2 emissions from Boilers 1, 2, and 3, in tons, each calendar month, by multiplying the amount of coal consumed in each calendar month by
an SO 2 emission factor of 38*S lb SO 2 /ton of coal burned, where S = the percent sulfur content of the coal as determined by Conditi on D.1.7. In addition, the Permittee shall
calculate the SO 2 emissions from burning natural gas in Boilers 1, 2, and 3, in tons, each calendar month, by multiplying the amount of natural gas burned in each calendar month by an SO 2 emission factor of 0.6 lb SO 2 /million cubic feet of natural gas burned.

After the coal feed to Boilers No. 1, No. 2, and No. 3 is shutdown, starting September 14, 2007, whichever comes first, the Permittee s hall calculate, one hundred percent (100%)
of the SO 2 emissions from Boilers 1, 2, and 3, each calendar month, by multiplying the amount of natural gas burned in each calendar month by a SO 2 emission factor of 0.6 lbs
SO 2 /million cubic feet of natural gas burned.

(b) The Permittee shall calculate SO 2 emissions from burning natural gas in Boilers 4 and 5, in tons, each calendar month, by multiplyi ng the amount of natural gas burned in each calendar month by an SO 2 emission factor of 0.6 lb SO 2 /million cubic feet of natural gas

burned.

(c) The Permittee shall calculate SO 2 emissions from burning fuel oil in Boilers 4 and 5, in tons, each calendar month, by multiplying t he amount of fuel oil burned in each calendar month by an SO 2 emission factor of 69.6 lb SO 2 /1000 gallons of fuel oil burned.

(d) The Permittee shall determine SO 2 emissions from diesel engines, in tons, each calendar month, through one of the methods described in (1) and (2) below. The Permittee shall identify which method it used when it reports emissions pursuant to Condition G.1.8.Eli Lilly and Company-Tippecanoe Labs 4 th Significant Permit Modificati on No. 157-22717-00006 Page 202 of 226 Lafayette, Indiana Modified by: Aida De Guzman OP No. T157-6879-00006 Permit Reviewer: Dr. Trip Sinha

(1) Potential to emit method: The Permi ttee shall use the following values, which represent the SO 2 potential to emit of the diesel engines, as the actual emissions:

(A) For the T121 1250 KW diesel electrical generator – 0.25 ton/month [3.0 ton/yr].

(B) For the T5 380 HP diesel emergency generator – 0.02 ton/month [0.2 ton/yr]

(C) For the T62 1100 KW diesel emer gency generator – 0.1 ton/month [1.5 ton/yr].

(D) For the T135 390 HP diesel emergency generator – 0.02 ton/month [0.2 ton/yr].

(E) For the T78 58 KW diesel compressor engine – 0.06 ton/month [0.7 ton/yr].

(F) For the T89-1 KW diesel compressor engine – 0.06 ton/month [0.7 ton/yr].

(G) For the T89-2 KW diesel compressor engine – 0.06 ton/month [0.7 ton/yr].

(2) Actual hours of operation method: The Permittee shall calculate SO 2 emissions from diesel engines by multiplying t he actual hours of operation per calendar month for each diesel engine by the engine’s horsepower rating and by an SO 2 emission factor of 0.0004045 lb SO 2 /brake horsepower-hour for diesel engines greater than 600 brake horse power and 0.00205 lb SO 2 /brake horsepower-hour for diesel engines smaller than 600 brake horse power

(e) The Permittee shall calculate SO 2 emissions from the T174 Thermal Research Incinerator, in tons, each calendar month, by multiplying the actual hours of operation of the incinerator for each month by a SO 2 emission factor of 4.56 lb SO 2 /hour of operation.

(f) The methods for determining monthly SO 2 emissions from the T49 Incinerator, the T149 Incinerator, the RTOs, and the T79 Fume Incine rators are described in Condition F.1.6 of this permit.

(g) SO 2 emissions from the T71 Pilot Plant are equivalent to the potential to emit for this facility – 1.5 ton/yr [0.125 ton/month].

(h) When determining actual annual emissions of SO 2 , the Permittee shall include emissions occurring as a result of startups, shutdown, and malfunctions.

(i) The Permittee shall calculate SO 2 emissions from burning natural gas in boilers No. 6 and No. 7, in tons, each calendar month by multiplying the amount of natural gas burned in each calendar month by an SO 2 emission factor of 0.6 lb SO 2 /million cubic feet of natural gas burned.

(j) The Permittee shall calculate SO 2 emissions from burning fuel oil in boilers No. 6 and No. 7, in tons, each calendar month, by multip lying the amount of fuel oil burned in eachEli Lilly and Company-Tippecanoe Labs 4 th Significant Permit Modificati on No. 157-22717-00006 Page 203 of 226 Lafayette, Indiana Modified by: Aida De Guzman OP No. T157-6879-00006 Permit Reviewer: Dr. Trip Sinha

calendar month by an SO 2 emission factor of 42.6 lb SO 2 /1000 gallons of fuel oil burned.

G.1.6 Revalidation of emissions determi nation methods [326 IAC 2-2.4-12(i)]

The Permittee shall revalidate the emissions determination methods described in Conditions G.1.4 and G.1.5 through performance testing or ot her scientifically valid means approved by the department no later than five years after the effective date of the PAL provisions.

Record keeping and reporting [326 IAC 2-7-5(3)] [326 IAC 2-7-19]

G.1.7 Record keeping requirements [ 326 IAC 2-7-5(3)] [326 IAC 2-2.4-13]

(a) The Permittee shall retain a copy of all records necessary to determine compliance with the requirements of this G Section, includi ng a determination of each emissions unit’s twelve (12) month rolling total emissions, fo r five years from the date of the record.

(b) The Permittee shall retain a copy of t he PAL permit application, any applications for revisions to the PAL, each annual compliance cert ification as required by Condition B.9 of this permit, and data relied on in the certificat ion for the duration of the PAL plus five

years.

G.1.8 Reporting requirements [326 IAC 2-7-5(3)] [326 IAC 2-2.4-14]

(a) The Permittee shall submit a semi-annual report, containing the information described below, to the address listed in Section C – Gene ral Reporting Requirements, within thirty (30) days after the end of the calendar quarte r being reported. This report requires the certification by the “responsibl e official” as defined by 326 IAC 2-7-1(34). The report shall include the following information:

(1) The identification of the owner and ope rator of the facility and the permit number.

(2) Total emissions of NOx and SO 2 , in tons per rolling 12 month period for each month in the reporting period, as det ermined by Conditions G.1.4 and G.1.5.

(3) All data relied upon, including but not lim ited to, any quality assurance or quality control data, in determining emissions.

(4) A list of any emissions units modified or added to the major stationary source during the reporting period.

(5) If not previously reported pursuant to another condition in this permit, the number, duration, and cause of any deviati ons or monitoring malfunctions, other

than the time associated with zero and span calibration checks, and any

corrective action taken.

(6) If not required to be reported pursuant to another condition in this permit, information about monitoring system shutdowns including the following

information:

(A) Notification to the department of the shutdown of any monitoring system.

(B) Whether the shutdown was permanent or temporary.

(C) The reason for the shutdown.

(D) The anticipated date that the monito ring system will be fully operational or replaced with another monitoring system.Eli Lilly and Company-Tippecanoe Labs 4 th Significant Permit Modificati on No. 157-22717-00006 Page 204 of 226 Lafayette, Indiana Modified by: Aida De Guzman OP No. T157-6879-00006 Permit Reviewer: Dr. Trip Sinha

(E) Whether the emissions unit moni tored by the monitoring system continued to operate.

(F) If the emission unit monitored by the monitoring system continued to operate, the calculation of the:

(i) Emissions of the pollutant; or

(ii) Number determined by method included in the permit, as provided by 326 IAC 2-2.4-12(g).

(b) The procedures for reporting deviations from the requirements of this Section G, and the procedures for reporting emissions in excess of the limits described in Condition G.1.1 are described in Condition B.14. A report that describes emissions exceeding the PAL limits shall include the quantity of emissions em itted by the source. This term satisfies the requirements of 326 IAC 2-2.4-14(c).

(c) The Permittee shall submit to the department the results of any revalidation test or method within three months of completion of the test or method. These results do not require responsible official certification.Eli Lilly and Company-Tippecanoe Labs 4 th Significant Permit Modificati on No. 157-22717-00006 Page 205 of 226 Lafayette, Indiana Modified by: Aida De Guzman OP No. T157-6879-00006 Permit Reviewer: Dr. Trip Sinha



## INDIANA DEPARTMENT OF EN VIRONMENTAL MANAGEMENT
OFFICE OF AIR QUALITY

Section D.1 – Utilities Operations Quarterly Coal Characteris tic and Consumption Report

Source Name: Eli Lilly and Company, Tippecanoe Laboratories Source Address: 1650 Lilly Road, Lafayette, Indiana 47909 Mailing Address: 1650 Lilly Road, Lafayette, Indiana 47909

Part 70 Permit No.: T157-6879-00006 Facility: Boilers 1, 2 and 3
Parameter: SO 2 emissions
Limit: 6.0 lbs/MMBtu

Quarter: _________________ Year: ______________

Month Sulfur Content (% Wt.) Heating Value (Btu/lb) Coal Consumption (tons) Emission Rate (lbs/MMBtu)

Check one of the following:

No deviation occurred in this quarter.

The following deviation/s occurred in this quarter.

Submitted by:__________________________________________________________________

Title / Position: _________________________________________________________________

Signature: ____________________________________________________________________

Date: ________________________________________________________________________

Phone: _______________________________________________________________________

Attach a signed certification to complete this report.Eli Lilly and Company-Tippecanoe Labs 4 th Significant Permit Modificati on No. 157-22717-00006 Page 206 of 226 Lafayette, Indiana Modified by: Aida De Guzman OP No. T157-6879-00006 Permit Reviewer: Dr. Trip Sinha



## INDIANA DEPARTMENT OF EN VIRONMENTAL MANAGEMENT
OFFICE OF AIR QUALITY

Section D.1 – Utilities Operations Quarterly Fuel Oil Characteristic and Consumption Report

Source Name: Eli Lilly and Company, Tippecanoe Laboratories Source Address: 1650 Lilly Road, Lafayette, Indiana 47909 Mailing Address: 1650 Lilly Road, Lafayette, Indiana 47909

Part 70 Permit No.: T157-6879-00006 Facility: Boilers 4 and 5
Parameter: SO 2 emissions
Limit: 0.5 lbs/MMBtu

Quarter: _________________ Year: ______________

Month Sulfur Content (% Wt.) Heating Value (Btu/lb) Fuel Oil Consumption (gallons) Emission Rate (lbs/MMBtu)

Boiler 4:

Boiler 5:

Check one of the following:

No deviation occurred in this quarter.

The following deviation/s occurred in this quarter.

Submitted by:__________________________________________________________________

Title / Position: _________________________________________________________________

Signature: ____________________________________________________________________

Date: ________________________________________________________________________

Phone: _______________________________________________________________________

Attach a signed certification to complete this report.Eli Lilly and Company-Tippecanoe Labs 4 th Significant Permit Modificati on No. 157-22717-00006 Page 207 of 226 Lafayette, Indiana Modified by: Aida De Guzman OP No. T157-6879-00006 Permit Reviewer: Dr. Trip Sinha



## INDIANA DEPARTMENT OF EN VIRONMENTAL MANAGEMENT
OFFICE OF AIR QUALITY

Section D.2 – Utilities Support Operations Quarterly Generator Hours Report

Source Name: Eli Lilly and Company, Tippecanoe Laboratories Source Address: 1650 Lilly Road, Lafayette, Indiana 47909 Mailing Address: 1650 Lilly Road, Lafayette, Indiana 47909

Part 70 Permit No.: T157-6879-00006 Facility: Generator T121

Parameter: NOx Emissions Limit: T121 = 900 hrs of operation per 12 month period, rolled on a monthly basis

Quarter: _________________ Year: ______________

Month Hours Used

This Month Hours/

12 Months

Check one of the following:

No deviation occurred in this quarter.

The following deviation/s occurred in this quarter.

Submitted by:__________________________________________________________________

Title / Position: _________________________________________________________________

Signature: ____________________________________________________________________

Date: ________________________________________________________________________

Phone: _______________________________________________________________________

Attach a signed certification to complete this report.Eli Lilly and Company-Tippecanoe Labs 4 th Significant Permit Modificati on No. 157-22717-00006 Page 208 of 226 Lafayette, Indiana Modified by: Aida De Guzman OP No. T157-6879-00006 Permit Reviewer: Dr. Trip Sinha



## INDIANA DEPARTMENT OF EN VIRONMENTAL MANAGEMENT
OFFICE OF AIR QUALITY

Section D.12-D.15 – Contro l Device CMS Operations Streamlined CMS Periodic Report

Source Name: Eli Lilly and Company, Tippecanoe Laboratories Source Address: 1650 Lilly Road, Lafayette, Indiana 47909 Mailing Address: 1650 Lilly Road, Lafayette, Indiana 47909

Part 70 Permit No.: T157-6879-00006

Quarter: _________________ Year: ______________

PART 1: CMS Exceedance Summary

Regulated

Entity CMS Brief Description Limits/UOM Manufacturer/

Model # Last Audit/ Annual

Calibration Date Description of changes in
CMS/CEMS

PART 2: CMS Downtime Summary

Exceedance Time by Cause (days)

Regulated

Entity Operating Time (days) CMSStartup/ShutdownControlEquipmentProblemProcessProblemOther knownOtherUnknown Total

Exceedance Time (days) Exceedances (as % of Operating Time)Eli Lilly and Company-Tippecanoe Labs 4 th Significant Permit Modificati on No. 157-22717-00006 Page 209 of 226 Lafayette, Indiana Modified by: Aida De Guzman OP No. T157-6879-00006 Permit Reviewer: Dr. Trip Sinha

PART 3: CMS Downtime Details, If Applicable

Control Device: ______________________ CMS/CEMS: ______________________ Operating Time: ______________________

Start

Date Start

Time End

Date End

Time Downtime Type SSM (yes/no) Nature and Cause of

Malfunction Nature of Repairs or Adjustment/ Corrective

Actions/ Preventive Measures

Control Device: ______________________ CMS/CEMS: ______________________ Operating Time: ______________________

Start

Date Start

Time End

Date End

Time Downtime Type SSM (yes/no) Nature and Cause of

Malfunction Nature of Repairs or Adjustment/ Corrective

Actions/ Preventive Measures

Control Device: ______________________ CMS/CEMS: ______________________ Operating Time: ______________________

Start

Date Start

Time End

Date End

Time Downtime Type SSM (yes/no) Nature and Cause of

Malfunction Nature of Repairs or Adjustment/ Corrective

Actions/ Preventive MeasuresEli Lilly and Company-Tippecanoe Labs 4 th Significant Permit Modificati on No. 157-22717-00006 Page 210 of 226 Lafayette, Indiana Modified by: Aida De Guzman OP No. T157-6879-00006 Permit Reviewer: Dr. Trip Sinha

PART 4: CMS Excursion Summary, If Applicable

Regulated Entity Operating Time (days) CMS Number of

Excursions % Excursion

PART 5: CMS Excursion Details, If Applicable

Control Device: ______________________ CMS/CEMS: ______________________ Operating Time: ______________________

Date Duration (days)

PART 6: Bypass Summary

Regulated Entity Date Start Time Building or Fume
Stream Duration (hrs) SSM Event?Eli Lilly and Company-Tippecanoe Labs 4 th Significant Permit Modificati on No. 157-22717-00006 Page 211 of 226 Lafayette, Indiana Modified by: Aida De Guzman OP No. T157-6879-00006 Permit Reviewer: Dr. Trip Sinha

PART 7: SSM Summary

REGULATED SOURCE DATE DURATION (hours) SSM EVENT

TYPE SSM PLAN

FOLLOWED? NOTES

Submitted by:__________________________________________________________________

Title / Position: _________________________________________________________________

Signature: ____________________________________________________________________

Date: ________________________________________________________________________

Phone: _______________________________________________________________________

Attach a signed certification to complete this report.Eli Lilly and Company-Tippecanoe Labs 4 th Significant Permit Modificati on No. 157-22717-00006 Page 212 of 226 Lafayette, Indiana Modified by: Aida De Guzman OP No. T157-6879-00006 Permit Reviewer: Dr. Trip Sinha



## INDIANA DEPARTMENT OF EN VIRONMENTAL MANAGEMENT
OFFICE OF AIR QUALITY

COMPLIANCE DATA SECTION

Section E – Leak Detection and Repair (LDAR) Program Streamlined LDAR Periodic Report

Source Name: Eli Lilly and Company, Tippecanoe Laboratories Source Address: 1650 Lilly Road, Lafayette, Indiana 47909 Mailing Address: 1650 Lilly Road, Lafayette, Indiana 47909

Part 70 Permit No.: T157-6879-00006

Period: _________________ Year: ______________

PART 1: LDAR Report for Process System Components

Process Unit: Equipment Type:
Service

Monitoring Period Number

Tested Number

Leakers Percent Leakers Process Unit Shutdown

Periods

Number of Components Number Added Number Removed

Process Unit: Equipment Type:
Service

Monitoring Period Number

Tested Number

Leakers Percent Leakers Process Unit Shutdown

Periods

Number of Components Number Added Number RemovedEli Lilly and Company-Tippecanoe Labs 4 th Significant Permit Modificati on No. 157-22717-00006 Page 213 of 226 Lafayette, Indiana Modified by: Aida De Guzman OP No. T157-6879-00006 Permit Reviewer: Dr. Trip Sinha

PART 2: LDAR Report for Waste Components

Process Unit: Equipment Type:
Service

Monitoring Period Number

Tested Number

Leakers Percent Leakers Process Unit Shutdown

Periods

Number of Components Number Added Number Removed

Process Unit: Equipment Type:
Service

Monitoring Period Number

Tested Number

Leakers Percent Leakers Process Unit Shutdown

Periods

Number of Components Number Added Number Removed

Submitted by:__________________________________________________________________

Title / Position: _________________________________________________________________

Signature: ____________________________________________________________________

Date: ________________________________________________________________________

Phone: _______________________________________________________________________

Attach a signed certification to complete this report.Eli Lilly and Company-Tippecanoe Labs 4 th Significant Permit Modificati on No. 157-22717-00006 Page 214 of 226 Lafayette, Indiana Modified by: Aida De Guzman OP No. T157-6879-00006 Permit Reviewer: Dr. Trip Sinha



## INDIANA DEPARTMENT OF EN VIRONMENTAL MANAGEMENT
OFFICE OF AIR QUALITY

COMPLIANCE DATA SECTION

PART 70 OPERATING PERMIT
SEMI-ANNUAL BOILERS NO. 6 an d NO. 7 CERTIFICATION

Source Name: Eli Lilly and Company, Tippecanoe Laboratories Source Address: 1650 Lilly Road, Lafayette, Indiana 47909 Mailing Address: 1650 Lilly Road, Lafayette, Indiana 47909

Part 70 Permit No.: T157-6879-00006 Facility: Boilers No. 6 and No.7

Natural Gas Very Low Sulfur Oil

From: To:

I certify that, based on information and belief fo rmed after reasonable inquiry, the statements and information in the document are true, accurate, and complete.

Signature:

Printed Name:

Title/Position:

Phone:

Date:

A certification by the responsible official as defin ed by 326 IAC 2-7-1(34) is required for this report.Eli Lilly and Company-Tippecanoe Labs 4 th Significant Permit Modificati on No. 157-22717-00006 Page 215 of 226 Lafayette, Indiana Modified by: Aida De Guzman OP No. T157-6879-00006 Permit Reviewer: Dr. Trip Sinha



## INDIANA DEPARTMENT OF EN VIRONMENTAL MANAGEMENT
OFFICE OF AIR QUALITY

COMPLIANCE DATA SECTION

Part 70 Quarterly Report

Source Name: Eli Lilly and Company, Tippecanoe Laboratories Source Address: 1650 Lilly Road, Lafayette, Indiana 47909 Mailing Address: 1650 Lilly Road, Lafayette, Indiana 47909

Part 70 Permit No.: T157-6879-00006 Facility: Boilers No. 6 and No.7
Parameter: CO

Limit: 98 tons/12 months

Quarter:__

______________ YEAR:__________

Column 1 Column 2 Column 1 + Column 2

Month

This Month Previous 11 Months 12 Month Total

Month 1

Month 2

Month 3

No deviation occurred in this quarter.

Deviation/s occurred in this quarter. Deviation has been reported on:_____________________________

Submitted by:______________________________________________

Title / Position: _____________________________________________

Signature:_________________________________________________

Date: ____________________________________________________

Phone: ___________________________________________________

Attach a signed certification to complete this report.Eli Lilly and Company-Tippecanoe Labs 4 th Significant Permit Modificati on No. 157-22717-00006 Page 216 of 226 Lafayette, Indiana Modified by: Aida De Guzman OP No. T157-6879-00006 Permit Reviewer: Dr. Trip Sinha



## INDIANA DEPARTMENT OF EN VIRONMENTAL MANAGEMENT
OFFICE OF AIR QUALITY

COMPLIANCE DATA SECTION

Part 70 Quarterly Report for First 12 months of Operation

Source Name: Eli Lilly and Company, Tippecanoe Laboratories Source Address: 1650 Lilly Road, Lafayette, Indiana 47909 Mailing Address: 1650 Lilly Road, Lafayette, Indiana 47909

Part 70 Permit No.: T157-6879-00006 Facility: Boilers No. 6 and No.7
Parameter: CO Limits: (1) 98 ton/12 months (2) Running Monthly Average: 8.17 tons

Quarter:__

______________ YEAR:__________

Column 1 Column 2 Column 1

+ Column 2 (Column 1 + Column 2) . (Total Months of Operation)

Month This

Month Previous

11 Months *Total Months of Operation Running average up to current month

Month 1

Month 2

Month 3

* When determining the total usage for previous 11 months, assume zero usage during the months when the boilers were not in operation.

No deviation occurred in this quarter.

Deviation/s occurred in this quarter. Deviation has been reported on:_____________________________

Submitted by:______________________________________________

Title / Position: _____________________________________________

Signature:_________________________________________________

Date: ____________________________________________________

Phone: ___________________________________________________

Attach a signed certification to complete this report.Eli Lilly and Company-Tippecanoe Labs 4 th Significant Permit Modificati on No. 157-22717-00006 Page 217 of 226 Lafayette, Indiana Modified by: Aida De Guzman OP No. T157-6879-00006 Permit Reviewer: Dr. Trip Sinha



## INDIANA DEPARTMENT OF ENVI RONMENTAL MANAGEMENT
OFFICE OF AIR QUALITY

COMPLIANCE DATA SECTION

Part 70 Quarterly Report

Source Name: Eli Lilly and Company, Tippecanoe Laboratories Source Address: 1650 Lilly Road, Lafayette, Indiana 47909 Mailing Address: 1650 Lilly Road, Lafayette, Indiana 47909

Part 70 Permit No.: T157-6879-00006 Facility: Boiler No.6 Parameter: Very low sulfur oil and hours fuel oil burned Limit: Less than 976,740 gallons/year = < 10% annual capacity for fuel oil

Quarter:__

______________ YEAR:__________

Column 1
This Quarter Column 2

Year Total Column 3 (Column 1 +

Column 2)

Year Total Quarter

No. of gallons No. of

hours No. of gallons No. of

hours No. of gallons No. of

hours Annual Capacity

for fuel oil

Quarter 1 January-March 0.0 0.0

Quarter 2 April-June

Quarter 3 July-September

Quarter 4

OctoberDecember

The boiler‘s maximum capacity to burn fuel oil is 9,767,400 gallons. Annual Capacity = No. of gallons of fuel oil burne d up to date for the year /9,767,400 gallons No deviation occurred in this quarter. Deviation/s occurred in this quarter. Deviation has been reported on:_____________________________

Submitted by:______________________________________________

Title / Position: _____________________________________________

Signature:_________________________________________________

Date: ____________________________________________________

Phone: ___________________________________________________

Attach a signed certification to complete this report.Eli Lilly and Company-Tippecanoe Labs 4 th Significant Permit Modificati on No. 157-22717-00006 Page 218 of 226 Lafayette, Indiana Modified by: Aida De Guzman OP No. T157-6879-00006 Permit Reviewer: Dr. Trip Sinha



## INDIANA DEPARTMENT OF EN VIRONMENTAL MANAGEMENT
OFFICE OF AIR QUALITY

COMPLIANCE DATA SECTION

Part 70 Quarterly Report

Source Name: Eli Lilly and Company, Tippecanoe Laboratories Source Address: 1650 Lilly Road, Lafayette, Indiana 47909 Mailing Address: 1650 Lilly Road, Lafayette, Indiana 47909

Part 70 Permit No.: T157-6879-00006 Facility: Boiler No. 7 Parameter: Very low sulfur oil and hours fuel oil burned Limit: Less than 976,740 gallons/year = < 10% annual capacity for fuel oil Quarter:__

______________ YEAR:__________

Column 1
This Quarter Column 2

Year Total Column 3 (Column 1 +

Column 2)

Year Total Quarter

No. of gallons No. of

hours No. of gallons No. of

hours No. of gallons No. of

hours Annual Capacity

Quarter 1 January-March 0.0 0.0

Quarter 2 April-June

Quarter 3 July-September

Quarter 4

OctoberDecember

The boiler‘s maximum capacity to burn fuel oil is 9,767,400 gallons. Annual Capacity = No. of gallons of fuel oil burne d up to date for the year /9,767,400 gallons No deviation occurred in this quarter. Deviation/s occurred in this quarter. Deviation has been reported on:_____________________________

Submitted by:______________________________________________

Title / Position: _____________________________________________

Signature:_________________________________________________

Date: ____________________________________________________

Phone: ___________________________________________________

Attach a signed certification to complete this report.Eli Lilly and Company-Tippecanoe Labs 4 th Significant Permit Modificati on No. 157-22717-00006 Page 219 of 226 Lafayette, Indiana Modified by: Aida De Guzman OP No. T157-6879-00006 Permit Reviewer: Dr. Trip Sinha



## INDIANA DEPARTMENT OF EN VIRONMENTAL MANAGEMENT
OFFICE OF AIR QUALITY

COMPLIANCE DATA SECTION

Part 70 Annual Report

Source Name: Eli Lilly and Company, Tippecanoe Laboratories Source Address: 1650 Lilly Road, Lafayette, Indiana 47909 Mailing Address: 1650 Lilly Road, Lafayette, Indiana 47909

Part 70 Permit No.: T157-6879-00006 Facility: Emergency Air Compressor (T26-COMP 5600A) Parameter: Hour of operation Limit: 500 Hours/year

YEAR: _____________

Hours of Operation

No deviation occurred in quarter.

Deviation/s occurred in this quarter. Deviation has been reported on:_____________________________

Submitted by:______________________________________________

Title / Position: _____________________________________________

Signature:_________________________________________________

Date: ____________________________________________________

Phone: ___________________________________________________

Attach a signed certification to complete this report.Eli Lilly and Company-Tippecanoe Labs 4 th Significant Permit Modificati on No. 157-22717-00006 Page 220 of 226 Lafayette, Indiana Modified by: Aida De Guzman OP No. T157-6879-00006 Permit Reviewer: Dr. Trip Sinha



## INDIANA DEPARTMENT OF EN VIRONMENTAL MANAGEMENT
OFFICE OF AIR QUALITY

COMPLIANCE BRANCH

100 North Senate Avenue

P.O. Box 6015 Indianapolis, Indiana 46206-6015

Phone: 317-233-0178

Fax: 317-233-6865



### PART 70 OPERATING PERMIT
EMERGENCY OCCURRENCE REPORT

Source Name: Eli Lilly and Company, Tippecanoe Laboratories Source Address: 1650 Lilly Road, Lafayette, Indiana 47909 Mailing Address: 1650 Lilly Road, Lafayette, Indiana 47909

Part 70 Permit No.: T157-6879-00006

This form consists of 2 pages

This is an emergency as defined in 326 IAC 2-7-1(12)

• The Permittee must notify the Office of Air Quality (OAQ), within four ( 4 ) business hours (1-

800-451-6027 or 317-233-0178, ask for Compliance Section); and • The Permittee must submit notice in writing or by facsimile within two ( 2 ) working days

(Facsimile Number: 317-233-6865), and follow the other requirements of 326 IAC 2-7-16.

If any of the following are not applicable, mark N/A

Facility/Equipment/Operation:

Control Equipment:

Permit Condition or Operation Limitation in Permit:

Description of the Emergency:

Describe the cause of the Emergency:Eli Lilly and Company-Tippecanoe Labs 4 th Significant Permit Modificati on No. 157-22717-00006 Page 221 of 226 Lafayette, Indiana Modified by: Aida De Guzman OP No. T157-6879-00006 Permit Reviewer: Dr. Trip Sinha

If any of the following are not applicable, mark N/A

Date/Time Emergency started:

Date/Time Emergency was corrected:

Was the facility being properly operated at the ti me of the emergency? Y N

Describe:

Type of Pollutants Emitted: TSP, PM-10, SO 2 , VOC, NO X , CO, Pb, other:

Estimated amount of pollutant(s) emitted during emergency:

Describe the steps taken to mitigate the problem:

Describe the corrective actions/response steps taken:

Describe the measures taken to minimize emissions:

If applicable, describe the reasons wh y continued operation of the fac ilities are necess ary to prevent imminent injury to persons, severe damage to equipmen t, substantial loss of capital investment, or loss of product or raw materials of substantial economic value:

Form Completed by: ____________________________________________________________

Title / Position: ________________________________________________________________

Date: ________________________________________________________________________

Phone: ______________________________________________________________________

A certification is not required for this report.Eli Lilly and Company-Tippecanoe Labs 4 th Significant Permit Modificati on No. 157-22717-00006 Page 222 of 226 Lafayette, Indiana Modified by: Aida De Guzman OP No. T157-6879-00006 Permit Reviewer: Dr. Trip Sinha



## INDIANA DEPARTMENT OF EN VIRONMENTAL MANAGEMENT
OFFICE OF AIR QUALITY

COMPLIANCE DATA SECTION

PART 70 OPERATING PERMIT
QUARTERLY DEVIATION AND COMPLIANCE MONITORING REPORT

Source Name: Eli Lilly and Company, Tippecanoe Laboratories Source Address: 1650 Lilly Road, Lafayette, Indiana 47909 Mailing Address: 1650 Lilly Road, Lafayette, Indiana 47909

Part 70 Permit No.: T157-6879-00006 Months: ___________ to ____________ Year: ______________

Permit Requirement (specify permit condition #)

Date of Deviation: Duration of Deviation:

Number of Deviations:

Probable Cause of Deviation:

Response Steps Taken:

Permit Requirement (specify permit condition #)

Date of Deviation: Duration of Deviation:

Number of Deviations:

Probable Cause of Deviation:

Response Steps Taken:

Permit Requirement (specify permit condition #)

Date of Deviation: Duration of Deviation:

Number of Deviations:

Probable Cause of Deviation:

Response Steps Taken:

Form Completed by: ____________________________________________________________

Title / Position: ________________________________________________________________

Date: ________________________________________________________________________

Phone: ______________________________________________________________________

Attach a signed certification to complete this report.Eli Lilly and Company-Tippecanoe Labs 4 th Significant Permit Modificati on No. 157-22717-00006 Page 223 of 226 Lafayette, Indiana Modified by: Aida De Guzman OP No. T157-6879-00006 Permit Reviewer: Dr. Trip Sinha



## INDIANA DEPARTMENT OF EN VIRONMENTAL MANAGEMENT
OFFICE OF AIR QUALITY

PART 70 OPERATING PERMIT
CERTIFICATION

Source Name: Eli Lilly and Company, Tippecanoe Laboratories Source Address: 1650 Lilly Road, Lafayette, Indiana 47909 Mailing Address: 1650 Lilly Road, Lafayette, Indiana 47909

Part 70 Permit No.: T157-6879-00006

This certification shall be included when s ubmitting monitoring, testing reports/results or other documents as required by this permit.

Please check what document is being certified:

Annual Compliance Certification Letter

Test Result (specify)_________________________________________________________

Report (specify) ____________________________________________________________

Notification (specify) ________________________________________________________

Affidavit (specify) ___________________________________________________________

Other (specify) _____________________________________________________________

I certify that, based on information and belief fo rmed after reasonable inquiry, the statements and information in the document are true, accurate, and complete.

Signature:

Printed Name:

Title/Position:

Phone:

Date:Eli Lilly and Company-Tippecanoe Labs 4 th Significant Permit Modificati on No. 157-22717-00006 Page 224 of 226 Lafayette, Indiana Modified by: Aida De Guzman OP No. T157-6879-00006 Permit Reviewer: Dr. Trip Sinha



## INDIANA DEPARTMENT OF EN VIRONMENTAL MANAGEMENT
OFFICE OF AIR QUALITY

Sections F.1 and G.1 – Change Manage ment and Flexible Permit Requirements, and Plantwide Applicability Limitations Requirements Quarterly Emission Limit Report

Source Name: Eli Lilly and Company, Tippecanoe Laboratories Source Address: 1650 Lilly Road, Lafayette, Indiana 47909 Mailing Address: 1650 Lilly Road, Lafayette, Indiana 47909

Part 70 Permit No.: T157-6879-00006 Facility: BPM Operations (RTOs, T79, T49, T149, Chemical WWTP, BPM Building Fugitives) Parameter: BPM Operations Emission Limit for VOC, CO, NOx, SO 2 , and Fluorides; T79 Fume Incinerator System Emission Sublimit for VOC

Limit:

Pollutant BPM Operations (tons/yr) T79 Fume Incinerator (tons/yr)

VOC 300 300

CO 150 30

NOx 300 30

SO 2 300 5

Fluorides 6 2

Facility: Source wide Parameter: Plantwide Emission Limits for NOx, and SO 2 ; PAL Limit:

Pollutant (Tons/yr)

NOx 648

SO 2 2,059

The attached spreadsheet provides the monthly actu al emissions for the BPM operations and PAL NOx

and SO 2 limits. The information is used to determine comp liance with the emission limits provided above. This emission summary report was:

Submitted by:__________________________________________________________________

Title / Position: _________________________________________________________________

Signature: ____________________________________________________________________

Date: ________________________________________________________________________

Phone: _______________________________________________________________________

Attach a signed certification to complete this report.Eli Lilly and Company-Tippecanoe Labs 4thSignificant Permit Modification No. 157-22717-00006 Page 225 of 226Lafayette, Indiana Modified by: Aida De Guzman OP No. T157-6879-00006Permit Reviewer: Dr. Trip SinhaSource Name: Eli Lilly and Company, Tippecanoe LaboratoriesSource Address: 1650 Lilly Road, Lafayette, Indiana 47909Mailing Address: 1650 Lilly Road, Lafayette, Indiana 47909Part 70 Permit No.: T157-6879-00006Actual Emission Estimates, tonsQuarter: Year:PollutantMonth 1Previous11 Months12-monthTotalMonth 2Previous 11Months12-monthTotalMonth 3Previous 11Months12-monthtotalRTOsVOC, PointCONOxSO2FluoridesT79 Fume Incinerator SystemVOC, PointCONOxSO2FluoridesT49 Liquid Waste IncineratorVOC, PointCONOxSO2FluoridesT149 Solid-Liquid Waste IncineratorVOC, PointCONOxSO2FluoridesChemical Wastewater Treatment Plant OperationsVOC, PointBPM Building OperationsVOC, FugitiveBPM TotalVOC (Point+ Fugitive)CONOxEli Lilly and Company-Tippecanoe Labs 4thSignificant Permit Modification No. 157-22717-00006 Page 226 of 226Lafayette, Indiana Modified by: Aida De Guzman OP No. T157-6879-00006Permit Reviewer: Dr. Trip SinhaActual Emission Estimates, tonsQuarter: Year:PollutantMonth 1Previous11 Months12-monthTotalMonth 2Previous 11Months12-monthTotalMonth 3Previous 11Months12-monthtotalSO2FluoridesBoilersNOxSO2Foul Air IncineratorNOxSO2Reciprocating EnginesNOxSO2Site TotalPAL LimitsNOxSO2Submitted by: _________________________________________________________________Title / Position: ________________________________________________________________Signature: ____________________________________________________________________Date: ________________________________________________________________________Phone:_______________________________________________________________________Attach a signed certificationto complete this report.

## Indiana Department of Environmental Management Office of Air Quality

Technical Support Document (TSD) for a Part 70 Significant Permit Modification

Source Description and Location

Source Name: Eli Lilly and Company – Tippecanoe Laboratories Source Location: 1650 Lilly Road, Lafayette, IN, 47909 County: Tippecanoe

SIC Code: 2833 and 2834 Operation Permit No.: T157-6879-00006 Operation Permit Issuance Date: February 27, 2004 Significant Permit Modification No.: SPM 157-22717-00006

Permit Reviewer: Aida De Guzman

Existing Approvals

The source was issued a Part 70 Operating Permit T157-6879-00006 on February 27, 2004. The source has since received the following:

(a) Significant Permit Modification No.: 157-20216-00006, issued on January 19, 2005;

(b) Significant Permit Modification No.: 157-20878-00006, issued on March 15, 2005;

(c) Administrative Amendment No.: 157-20003-00006, issued on April 1, 2005;

(d) Administrative Amendment No.: 157-21143-00006, issued on May 11, 2005;

(e) Significant Permit Modification No .: 157-20732-00006, issued on August 15, 2005; and

(f) Significant Permit Modification and PAL Permit No.: 157-21811-00006, issued on May 9,

2006.

County Attainment Status

The source is located in Tippecanoe County.

Pollutant Status

PM 10 Attainment

PM 2.5 Attainment

SO 2 Attainment

NO 2 Attainment

8-hour Ozone Attainment

CO Attainment

Lead Attainment

(a) Volatile organic compounds (VOC) and Nitrogen Oxides (NOx) are regulated under the Clean Air Act (CAA) for the purposes of attaining and maintaining the National Ambient Air Quality Standards (NAAQS) for ozone. Therefore, VOC and NOx emissions are considered when evaluating the rule applicability relating to ozone. Tippecanoe County has been designated as attainment or unclassifiable for ozone. Therefore, VOC and NOx emissions were reviewed pursuant to the r equirements for Prevention of SignificantEli Lilly and Company – Tippecanoe Laboratories Page 2 of 60 Lafayette, Indiana SPM No.:157-22717-00006

Permit Reviewer: Aida De Guzman Deterioration (PSD), 326 IAC 2-2.

(b) Tippecanoe County has been classified as attainment for PM 2.5 . U.S. EPA has not yet established the requirements for Prevention of Significant Deterioration (PSD), 326 IAC 2-

2 for PM 2.5 emissions. Therefore, until the U.S.EPA adopts specific provisions for PSD

review for PM 2.5 emissions, it has directed states to regulate PM 10 emissions as a surrogate for PM 2.5 emissions.

(c) Tippecanoe County has been classified as attainment or unclassifiable for CO, lead, NO 2 , PM 10 , and SO 2 . Therefore, these emissions were reviewed pursuant to the requirements for Prevention of Significant Deterioration (PSD), 326 IAC 2-2.

(d) Since this source is classified as a chem ical process plant, it is considered one of the twenty-eight (28) listed source categories, as specified in 326 IAC 2-2-1(gg)(1).

(e) Fugitive Emissions Since this type of operation is one of the twenty-eight (28) listed source categories under 326 IAC 2-2, fugitive emissions are counted toward the determination of PSD applicability.

Source Status

The table below summarizes the potential to emit of the entire source, prior to the proposed modification, after consideration of all enforc eable limits established in the effective permits:

Pollutant Emissions (tons/year)

PM >100

PM 10 >100

SO 2 >100

VOC >100

CO >100

NO

x >100

(a) This existing source is a major stationary source, under PSD (326 IAC 2-2), because a regulated pollutant is emitted at a rate of 100 tons per year or more, and it is one of the twenty-eight (28) listed source categories, as specified in 326 IAC 2-2-1(gg)(1).

(b) These emissions are based upon 2003 OAQ emission data submitted by Eli Lilly and Company.

The table below summarizes the potential to emit HAPs for the entire source, prior to the proposed modification, after consideration of all enforceable limits established in the effective permits:

HAPs Potential To Emit (tons/year) Single HAP >10

Total HAPs >25

This existing source is a major source of HAPs, as defined in 40 CFR 63.41, because HAP emissions are greater than twenty-five (25) tons per year for a combination of HAPs. Therefore, this source is a major source under Section 112 of the Clean Air Act (CAA).Eli Lilly and Company – Tippecanoe Laboratories Page 3 of 60 Lafayette, Indiana SPM No.:157-22717-00006

Permit Reviewer: Aida De Guzman

Actual Emissions

The following table shows the actual emissions fr om the source. This information reflects the 2003
OAQ emission data.

Pollutant Actual Emissions (tons/year)

PM 10 394

SO 2 1,123

VOC 111

CO 155

NO

x 349

HAP Actual Emissions (tons/year)

METHANOL 11.9

CHLOROFORM 1.01

N,NDIMETHYLFORMAMIDE 0.255

ACETONITRILE 2.77

DICHLOROMETHANE (METHYLENE CHLORIDE) 9.7

ACETOPHENONE 0.13

BENZOYL CHLORIDE 0.503

1,2-DICHLOROETHANE (ETHYLENE DICHLORIDE) 0.255

ETHYLENE GLYCOL 5.65

TOLUENE 3.71

PHENOL 0.005

N-HEXANE 44.4

TRIETHYLAMINE 0.466

N-METHYL-2-
PYRROLIDONE 0.255

MERCURY 0.007

HYDROCHLORIC ACID (1995 AND AFTER "ACID AEROSOLS" ONLY) 10.98

AMMONIA 2.25Eli Lilly and Company – Tippecanoe Laboratories Page 4 of 60 Lafayette, Indiana SPM No.:157-22717-00006

Permit Reviewer: Aida De Guzman Pollutant Actual Emissions (tons/year)

SULFURIC ACID (1994

AND AFTER "ACID AEROSOLS" ONLY) 12.6

CHLORINE 0.503

GLYCOL ETHERS 0.75

LEAD COMPOUNDS 0.013

DIOXIN AND DIOXIN-LIKE

COMPOUNDS Neg.

Background and Description of Proposed Modification

The Office of Air Quality (OAQ) has reviewed a modification application, submitted by Eli Lilly and Company on September 19, 2005, relating to the modification of the issued Part 70 Permit No. 157-6879-00006, issued on February 27, 2004, to include the following:

(a) Incorporation of the applicable require ments including COM alternative Monitoring determined in Significant Source Modi fication No.: 157-21809-00006, issued on June 7, 2006, for the two new natural gas and very low sulfur oil (as defined in 40 CFR 60.41b) fired boilers, one natural gas emergency generator and one diesel emergency compressor. The following is the list of the emissions units:

Emissions

Unit ID Emissions Unit Description Stack/Vent Nominal Capacity UOM Control

Device

Building T26:

BLR006 Natural Gas/Fuel Oil

Boiler No. 6 S-T26-

BLR006 156.1 MMBtu/hr None

BLR007 Natural Gas/Fuel Oil

Boiler No. 7 S-T26-

BLR007 156.1 MMBtu/hr None

T26-GEN7500A Natural Gas Powered Emergency Generator S-T26- GEN7500A 125 KW None

T26-COMP

5600A Diesel Powered Emergency Air Compressor S-T26- COMP

5600A 125 Hp None

(b) Incorporation of the Alternative Moni toring Plan (AMP), approved by US EPA on January 27, 2006 in lieu of the existing Continuous Em issions Monitoring Systems (CEMS) for the T149 rotary kiln incinerator; and

(c) Request changes to existing sections and condi tions of the Part 70 permit, as detailed in

the Changes to the Part 70 section of this TSD.

Enforcement Issue

There are no enforcement actions pending.

Permit Level Determination – Part 70

This modification is subject to 326 IAC 2-7-12(d), Si gnificant Permit Modification, since it involves incorporating applicable requirements for emi ssion units permitted in Significant Source Modification No. 157-21809-0006, issued on June 7, 2006, and a request for significant changes to existing monitoring Part 70 terms or conditions that do not qualify as minor permit modificationEli Lilly and Company – Tippecanoe Laboratories Page 5 of 60 Lafayette, Indiana SPM No.:157-22717-00006

Permit Reviewer: Aida De Guzman or as an administrative amendment.

Federal Rule Applicability Determination

There are no additional federal rules that will be applicable to the source as a result of this permit

modification.

State Rule Applicability Determination

There are no additional state rules that will be applicable to the source as a result of this permit

modification.

Changes to the Part 70 Permit

The changes listed below have been made to the Part 70 Operating Permit No. 157-6879-00006, issued on February 27, 2004. Deleted language appears as strikethroughs and new language appears in bold :

(1) Starting September 13, 2007, Coal/Natural Gas Boilers No. 1, No. 2, and No. 3, found in SECTION A.2(a) and SECTION D.1 will no longer be using coal. These boilers including Natural Gas/Fuel Oil Boilers No. 4, and No. 5 will be moved to SECTION D.20, and SECTION D.20 will supersede SECTION D.1. Therefore, SECTION A.2(a) and SECTION D.20 have been changed as follows:

A.2 Emission Units and Pollution Control Equipment Summary [326 IAC 2-7-4(c)(3)] [326 IAC 2-7- 5(15)]

This stationary source consists of the follo wing emission units and pollution control devices:

(a) D.1 Utilities Operations : The utilities operations consist of three coal/natural gas-fired boilers equipped with an ash handling system and supported by a coal pile and coal conveyor system, and two natural gas boilers with fuel oil backup supplied by one fuel oil tank. The boilers provide steam to process operations in bulk pharmaceutical manufacturing and fermented products. The detailed equipment list is located in Section D.1 of this permit. Section D.1 will be superseded by Secti on D.20 starting September 13, 2007. This is the compliance date of 40 CFR 63 Subpart DDDDD (Boiler MACT). At this time, the coal feed to Boilers No. 1, No. 2, and No. 3 will be shut off, and these boilers will burn 100% natural gas.

SECTION D.1 UTILITIES OPERATION CONDITIONS

Facility Description [326 IAC 2-7-5(15)]

The information describing the processes contained in the following facility description boxes is descriptive

information and does not constitute enforceable conditions:

This section will no longer be in effect when all of the coal chutes to Boilers No. 1, No. 2, and No. 3 are disconnected, starting September 13, 2007.Eli Lilly and Company – Tippecanoe Laboratories Page 6 of 60 Lafayette, Indiana SPM No.:157-22717-00006

Permit Reviewer: Aida De Guzman

(a) The following emission units are subject to app licable requirements described in this D section:

Emission*

Unit ID Emission Unit Description Stack/Vent Nominal Capacity UOM Control

Device

Building T6:

BLR001 Coal/Natural Gas Boiler S-T6-BLR001 92 MMBtu/hr Multiclone001

BLR002 Coal/Natural Gas Boiler S-T6-BLR002 92 MMBtu/hr Multiclone002

BLR003 Coal/Natural Gas Boiler S-T6-BLR003 92 MMBtu/hr Multiclone003

BLR004 Natural Gas/Fuel Oil Boiler S-T6-BLR004 142 MMBtu/hr None

BLR005 Natural Gas/Fuel Oil Boiler S-T6-BLR005 97 MMBtu/hr None

CONASH Ash Handling System PV-T6-
CONASH 1805 lbs/hr Baghouse

* In this permit, boilers BLR001, BLR002, BLR003, BLR004, and BLR005 are referred to as Boilers 1, 2, 3, 4, and 5, respectively.

(b) The following emission units are not subject to applicable requirements described in this D section and are listed only for informational purposes:

Emission

Unit ID Emission Unit Description Stack/Vent Nominal Capacity UOM Control

Device

Outside Building T6:

OILTK001* Fuel Oil Storage Tank PV-T6-
OILTK001 250,000 gallons None

COAL Coal Pile N/A N/A N/A N/A

CNV001-

CNV005 Covered Coal Conveyor System N/A N/A N/A N/A

• Emission units marked with a single aste risk are insignificant activi ties as defined in 326 IAC 2-7-1(21). Specifically, the fuel oil storage tank is an insignificant activity pursuant to 326 IAC 2-7-1(21)(A)-(C).

Condition D.1.0 has been added in SECTION D.1 as follows:

D.1.0 SECTION D.1 Requirements Supersession

The requirements of this SECTION D.1 shall be superseded by SECTION D.20 and therefore, shall no longer be in effect starting September 13, 2007.

(2) Condition D.1.1 has been incorporated in Condition D.20.5 for Boilers 1, 2, and 3, which will take effect starting September 13, 2007. The heat input rating of the natural gas burners for each of boilers no.1, no.2, and no.3 are less than the heat input rating for burning coal, 92 MMBtu/hr rating was changed to 50 MMBtu/hr.

The PM limit of 0.56 lb/MMBtu based on the source’s total heat input capacity (Q), of 276 MMBtu/hr is now 0.88 lb/MMBtu based on Q of 150 MMBtu/hr. However, Eli Lilly, chose to keep the current PM limit, which is lower. 3 (92 MMBtu/hr) = 276 MMBtu/hr 3 (50 MMBtu/hr)) = 150 MMBtu/hr

See Condition D.20.5 for the changes made.

(3) Rule 326 IAC 7-1 in Condition D.1.2 only applies to facilities, burning coal, distillate oil, and residual oil. This condition was incorporated in Condition D.20.3 for Boilers 4 and 5 only, which will take effect starting Septem ber 13, 2007. See Condition D.20.3 below for the changes made.Eli Lilly and Company – Tippecanoe Laboratories Page 7 of 60 Lafayette, Indiana SPM No.:157-22717-00006

Permit Reviewer: Aida De Guzman

(4) Condition D.1.8 requirements are for Boilers 4 and 5 which do not combust coal. However, these boilers will be moved to SECTION D.20 at the same time Boilers 1, 2 and 3 will cease using coal. This condition was incorporated in Condition D.20.13, which will take effect starting September 13, 2007. See Condition D.20.13 below for the changes

made.

(5) Condition D.1.13 requirements are for Boilers 4 and 5 which do not combust coal. However, these boilers will be moved to SECTION D.20 at the same time Boilers 1, 2 and 3 will cease using coal. This condition was incorporated in Condition D.20.17, which will take effect starting September 13, 2007. See Condition D.20.17 below for the changes

made.

(6) Condition D.1.16, D.1.17(a), and D.1.18 are applicable to Boilers 1, 2 and 3 when combusting coal. These conditions will no l onger be applicable starting September 13, 2007, since these boilers will cease using coal for fuel. Condition D.1.18 was incorporated in Condition D.20.18, which will take effect starting September 13, 2007. See Condition D.20.18 below for the changes made.

(7) The following SECTION D.20 has been added to the Part 70 permit to incorporate the applicable requirements for Natural Gas/Fuel Oil Boilers No.6 and No.7, generator (T26- GEN-7500A), and compressor (T26-COMP-5600A), permitted in Significant Source Modification 157-21809-0006. SECTION D.20 will also incorporate requirements for Boilers 1, 2, 3 and Natural Gas/Fuel Oil Boilers BLR004, and BLR005, which would be effective starting September 13, 2007 when using coal for fuel will be discontinued.

The emergency generator T26-GEN-7500A (insigni ficant activity), heat input rating has been changed from 125 KW to 150 KW, in administrative amendment 157-21143-00006, issued on May 11, 2005. This change did not get included in the last permit modification.

SECTION D.20 FACILITY OPERATION CONDITIONS

Facility Description [326 IAC 2-7-5(15)]

The information describing the processes contained in the following facility description boxes is descriptive

information and does not constitute enforceable conditions:

(a) The following emissions units are subject to applicable requirements described in this D

section:

Emissions

Unit ID Emissions Unit Description Stack/Vent Nominal Capacity UOM Control

Device

Building T6

BLR001 Natural Gas Boiler No. 1 S-T6-BLR001 50 MMBtu/hr None

BLR002 Natural Gas Boiler No. 2 S-T6-BLR002 50 MMBtu/hr None

BLR003 Natural Gas Boiler No. 3 S-T6-BLR003 50 MMBtu/hr None

BLR004 Natural Gas/Fuel Oil

Boiler No. 4 S-T6-BLR004 142 MMBtu/hr None

BLR005 Natural Gas/Fuel Oil

Boiler No. 5 S-T6-BLR005 97 MMBtu/hr None

Building T26

BLR006 Natural Gas/Fuel Oil

Boiler No. 6 S-T26-

BLR006 156.1 MMBtu/hr None

BLR007 Natural Gas/Fuel Oil

Boiler No. 7 S-T26-

BLR007 156.1 MMBtu/hr None

T26-GEN7500A Natural Powered Emergency Generator S-T26- GEN7500A 150 KW NoneEli Lilly and Company – Tippecanoe Laboratories Page 8 of 60 Lafayette, Indiana SPM No.:157-22717-00006

Permit Reviewer: Aida De Guzman

T26-COMP

5600A Diesel Powered Emergency Air Compressor S-T26- COMP

5600A 125 Hp None

* Emission units marked with a single asterisk are in significant activities as defined in 326 IAC 2-7-1(21).

(b) The following emission units are not subject to applicable requirements described in this D section and are listed only for informational purposes:

Emission

Unit ID Emission Unit Description Stack/Vent Nominal Capacity UOM Control

Device

Outside Building T6:

OILTK001* Fuel Oil Storage Tank PV-T6-

OILTK001 250,000 gallons None

* Emission units marked with a single asterisk are insignificant activities as defined in326 IAC 2-7-1(21). Specifically, the fuel oil storage tank is an insi gnificant activity pursuant to 326 IAC 2-7-1(21)(A)-(C).

Emission Limitations and Standards [326 IAC 2-7-5(1)]

D.20.0 Natural Gas Fuel Usage

Boilers No.1, No. 2, and No. 3 shall burn only natural gas on and after September 13, 2007.

D.20.1 General Provisions Relating to NSPS and NESHAP [326 IAC 12-1] [40 CFR 60, Subpart A] [40 CFR 63, Subpart A] [326 IAC 20-1]

(a) The provisions of 40 CFR Part 60, Subpart A - General Provisions, which are incorporated by reference in 326 IAC 12-1, apply to Boilers No. 6 and No.7 described in this section except when otherwise specified in 40 CFR Part 60, Subpart Db.

(b) Pursuant to 40 CFR 63.7505, the Permittee shall comply with the provisions of 40 CFR Part 63, Subpart A – General Provisions, which are incorporated by reference as 326 IAC 20-1-1, for Boilers No. 6 and No.7, as specified in Appendix A of 40 CFR Part 63, Subpart DDDDD in accordance with the schedule in 40 CFR 63, Subpart

DDDDD

.

D.20.2 Opacity Limitations [326 IAC 5] [40 CFR 60.43b] [326 IAC 12] [326 IAC 2-7-24]

(a) Notwithstanding Condition C.2, pursuant to 326 IAC 12 the opacity from Boilers No. 6 and No.7 shall not exceed 20% for any 6-minute block period, except for one 6- minute period per hour of not more than 27 percent opacity. Pursuant to 326 IAC 12, the opacity limit does not apply during periods of startups, shutdowns, or malfunctions. However, the general opacity requirements of Condition C.2 apply at all times. This condition expires when the revisions made to 40 CFR 60 Subpart Db, as amended on February 27, 2006, become effective as Indiana law. This condition is not federally enforceable.

(b) When starting up or shutting down Boilers No. 6 and No.7, opacity may exceed the applicable limit in Condition C.2. However, opacity levels shall not exceed sixty percent (60%) for any six (6)-minute averaging period. Opacity in excess of the applicable limit established in 326 IAC 5-1-2 shall not continue for more than twoEli Lilly and Company – Tippecanoe Laboratories Page 9 of 60 Lafayette, Indiana SPM No.:157-22717-00006

Permit Reviewer: Aida De Guzman (2) six (6)-minute averaging periods in any twenty-four (24) hour period.

(c) Pursuant to 40 CFR 60.43b(h)(5), because Boilers No. 6 and No. 7 will burn only very low sulfur oil or natural gas, the boilers are not subject to opacity limitations in 40 CFR 60.43b(f) and (g).

D.20.3 Sulfur Dioxide (SO 2 ) Limitations [326 IAC 7-1.1-2] [40 CFR 60.41b] [40 CFR 60.42b(k)] [326 IAC 12] [326 IAC 2-7-24]

(a) Pursuant to 326 IAC 7-1.1 (SO 2 Emission Limitations), 326 IAC 12, and 40 CFR 60, Subpart Db (Standards of Performance for Industrial-Commercial-Institutional Steam Generating Units):

(1) The SO 2 emission rate from Boilers No. 6 and No.7 shall not exceed 0.32 pounds per million Btu heat input; or

(2) The fuel oil shall contain no more than 0.3 weight percent sulfur.

(3) If the Permittee burns either natural gas or very low sulfur oil, the Permittee shall be in compliance with Conditions D.20.3(a)(1) and (2).

(b) Pursuant to 40 CFR 60 Subpart Db, the fuel oil sulfur content or sulfur dioxide emission limit applies at all times, incl uding periods of startup, shutdown, and

malfunction.

(c) Pursuant to 326 IAC 7-1.1-2 (Sulfur Dioxide Emission Limitations), the SO 2 emissions from Boilers No. 4 and No. 5 shall not exceed 0.5 lb/MMBtu of heat input when burning No. 2 fuel oil. Pursuant to 326 IAC 7-2-1, compliance with this standard is based on a calendar month average. This emission limit correlates to a maximum fuel sulfur content of 0.49 percent by weight.

On and after September 13, 2007, section (c) of this Condition D.20.3 shall apply.

D.20.4 Nitrogen Oxides (NOx) Limitations [40 CFR 60.44b] [326 IAC 12]

Pursuant to 40 CFR 60.44b(a), the NOx emission rate from Boilers No. 6 and No.7 shall not exceed 0.2 lb per MMBtu per boiler. The NOx emission limit shall be based on a 30-day rolling average. The NOx emission limit applies at all times, including periods of startup, shutdown, and malfunction.

D.20.5 Particulate Matter (PM) Limitations [40 CFR 63.7505] [40 CFR Subpart DDDDD, Table 1] 326 IAC 20-1] [326 IAC 6-2-3] [326 IAC 2-7-24]

(a) Pursuant to 326 IAC 6-2-3(b) (Particulate Matter Emission Limitations for Sources of Indirect Heating), particulate emissions fr om each natural gas-fired boiler (Boilers No. 1, No. 2, and No. 3) shall not exceed 0.56 pounds per million British thermal units (MMBtu) heat input.

(b) Pursuant to 326 IAC 6-2-3(c) (Particulate Matter Emission Limitations for Sources of Indirect Heating), particulate emissions from Boiler No. 4 shall not exceed 0.39 pounds per MMBtu heat input.

(c) Pursuant to 326 IAC 6-2-3(c) (Particulate Matter Emission Limitations for Sources of Indirect Heating), particulate emissions from Boiler No. 5 shall not exceed 0.31 pounds per MMBtu heat input.

(d) Pursuant to 40 CFR 63 Subpart DDDDD, Table 1, and 326 IAC 6-2-4(a), the PMEli Lilly and Company – Tippecanoe Laboratories Page 10 of 60 Lafayette, Indiana SPM No.:157-22717-00006

Permit Reviewer: Aida De Guzman emission rate from each of Boilers No. 6 and No.7 shall not exceed 0.03 pounds per MMBtu heat input. The particulate matter emission limit applies at all times except during periods of startup, shutdown, or malfunction.

On and after September 13, 2007, sections (a) through (c) of this Condition D.20.5 shall apply.

D.20.6 Hydrogen Chloride (HCl) Limitations [40 CFR 63.7505] [40 CFR 63 Subpart DDDDD, Table 1][326 IAC 20-1]

Pursuant to 40 CFR 63 Subpart DDDDD, Table 1, the HCl emission rate from Boilers No. 6 and No.7 shall not exceed 0.0005 pounds per MMBtu heat input. The hydrogen chloride emission limit applies at all times except dur ing periods of startup, shutdown, or

malfunction.

D.20.7 Carbon Monoxide (CO) Limitations [40 CFR 63 Subpart DDDDD, Table 1] [40 CFR 63.7505] [40 CFR 63.7525] [40 CFR 63.7540] [326 IAC 20-1]

Pursuant to 40 CFR 63, Subpart DDDDD, Table 1, CO emission rate from each of Boilers No. 6 and No.7 shall not exceed 400 ppmdv at 3% Oxygen based on a rolling 30-day average. The CO emission limit does not a pply during periods of startup, shutdown, malfunction, or when boiler loads are below 50% (40 CFR 63.7540(a)(10)(ii).

D.20.8 PSD Minor Limitations for CO [326 IAC 2-2]

(a) The total carbon monoxide emissions from Boilers No. 6 and No.7 shall be less than 98 tons per twelve consecutive month period with the compliance determined

at the end of each month.

During the first twelve (12) months after startup of either Boilers No. 6 or No. 7, the total carbon monoxide emissions divided by the accumulated months of operation shall not exceed 8.17 tons up to a maximum total of 98 tons for the first twelve (12) months of operation of the boilers.

(b) The hours of operation of the emergency air compressor shall be limited to 500 hours per year. The Permittee shall monito r the operating hours of the emergency air compressor with a non-resettable hour meter, as required by 40 CFR 60.4209(a).

Compliance with the CO emission limit of Boilers No. 6 and No. 7, and the hours of operation of the emergency air compressor will render 326 IAC 2-2 (Prevention of Significant Deterioration) not applicable to this modification.

D.20.9 NSPS Capacity Limitations [AMP approval 11-22-2005] [326 IAC 12] [40 CFR 60, Subpart Db]

The amount of very low sulfur oil with a maximum sulfur content of 0.3%, burned in each of Boilers No. 6 and No. 7 shall be less than 976,740 gallons per year.

This will limit the very low sulfur oil annual capacity factors of Boilers No. 6 and No.7 to less than 10 percent. This fuel oil use limit will qualify fuel oil use as “infrequent use” under 40 CFR 60.13(i)(20), which is the requirement of an alternative monitoring plan (AMP) for opacity in lieu of installing continuous opacity monitoring systems.

A quarterly summary of the very low sulfur oil use report shall be submitted with the opacity excess emission report. Each quarterly report must be submitted within 30-days after the end of each quarter (January-March, April-June, July-September, and OctoberDecember).Eli Lilly and Company – Tippecanoe Laboratories Page 11 of 60 Lafayette, Indiana SPM No.:157-22717-00006

Permit Reviewer: Aida De Guzman

This condition expires when the revisions made to 40 CFR 60 Subpart Db as amended on February 27, 2006, become effective as Indiana law. This condition is not federally

enforceable.

D.20.10 Required Plans and Procedures [40 CFR Part 63, Subpart DDDDD] [326 IAC 20-1]

(a) Pursuant to 63.7505(d), the Permittee shall develop and submit to the IDEM, OAQ for approval a site-specific monitoring plan for Boilers No. 6 and No. 7 that addresses paragraphs 40 CFR 7505 (d)(1)(i) through (iii). The Permittee must submit this site-specific monitoring plan at least 60 days before the initial performance

evaluation of CMS.

(b) Pursuant to 40 CFR 63 7505(e), the Permittee must develop and implement a written startup, shutdown, and malfunction plan (SSMP) for Boilers No. 6 and No. 7 according to the provisions in 40 CFR 63.6(e)(3).

(c) Continuous Emission Monitor Standard Operating Procedures (CEMS SOP) – The Permittee shall prepare and implement a CEMS SOP for each required CEMS. The SOP for the CO monitor shall meet the requirements of 40 CFR 63.8(d) and (e).

D.20.11 Preventive Maintenance Plan [326 IAC 2-7-5(13)]

A Preventive Maintenance Plan, in accordance with Section B - Preventive Maintenance Plan, of this permit, is required for the boilers.

Testing and Monitoring Requirements [326 IAC 2-7-6(1), (6)] [326 IAC 2-7-5(1)]

D.20.12 Opacity Monitoring Requirements [U. S. EPA Alternative Monitoring Plan approval 11/22/2005] [326 IAC 12]

(a) At least six consecutive minutes of visible emission observations of the stack

exhaust for Boilers No. 6 and No.7 must be conducted. These must be conducted at least once during each daylight shift during which fuel oil is being combusted.

Visible emissions must be conducted when the maximum rate of fuel oil for that shift is being burned. The observer conducting the visible emissions must be

certified to read visible emissions in accordance with the United States Environmental Protection Agency’s Reference Method 9 (USEPA RM9).

(b) At least six consecutive minutes of visible emissions must be conducted for each boiler whenever the respective boiler reaches the expected operating load after a cold start-up. These visible emissions readings must be conducted by an observer

certified in accordance with USEPA RM9.

(c) If visible emissions conducted in accord ance with either condition (a) or condition (b) above identify an average opacity exceeding 10 percent, the observer must

collect at least two additional sets of consecutive six minute visible emissions readings within that hour.

(d) The Permittee must create records of visible emissions in accordance with 40 CFR

60.7. These records must include at least the date and time of visible emission observations along with the results of all readings and average calculated.

(e) If at any time the annual capacity factor for burning very low sulfur oil is 10 percent or more, the Permittee will no longer qualify for this alternative opacity monitoring plan. The Permittee will then be required to propose a schedule for installing, certifying and operating continuous opacity monitoring system for each boilerEli Lilly and Company – Tippecanoe Laboratories Page 12 of 60 Lafayette, Indiana SPM No.:157-22717-00006

Permit Reviewer: Aida De Guzman identified above.

This condition expires when the revisions made to 40 CFR 60 Subpart Db, as amended on February 27, 2006, become effective as Indiana law. This condition is not federally

enforceable.

D.20.13 Compliance Requirements for SO 2 [326 IAC 7-2] [40 CFR 60.45b(j)] [40 CFR 60.47b(f)] [326 IAC 12]

Boilers No. 6 and No. 7 are subject to the following requirements:

(a) The Permittee shall burn only natural gas or very low sulfur fuel oil.

(b) The Permittee shall demonstrate that the oil burned meets the definition of very low sulfur fuel oil by:

(1) Following the performance testing procedures as described in 40 CFR 60.45b(c) or 40 CFR 60.45b(d); or

(2) Maintaining fuel receipts as described in 40 CFR 60.49b(r).

Compliance monitoring is not required when burning very low sulfur fuel oil.

On and after September 13, 2007, this condition shall also apply to Boilers No. 4 and No. 5.

D.20.14 Initial Performance Test Requirements for NOx [40 CFR 60.46b] [326 IAC 12] [326 IAC 3-6- 3] [326 IAC 2-7-24] [326 IAC 2-1.1-11] [40 CFR Part 60.8]

(a) Within 60 days after achieving the maximum production rate, but no later than 180 days after initial startup, the NOx emissions from Boilers No. 6 and No. 7 shall be monitored for 30 successive steam generating unit operating days and the 30-day average emission rate shall be used to determine compliance with the nitrogen oxides emission standards under 40 CFR 60.44b. The 30-day average emission rate is calculated as the average of all hourly emissions data recorded by the monitoring system during the 30-day test period.

(b) Subsequent performance test shall be performed upon request by IDEM, OAQ [40 CFR 60.46b (e) (4)].

D.20.15 Initial and Continuous Compliance Requirements for PM, HCl and CO [40 CFR 63.7506] [40 CFR 63.7510] [40 CFR 63.7530] [40 CFR 63.7540] [326 IAC 20-1]

(a) The Permittee must demonstrate initial compliance with the emission limits of PM and HCl and CO work practice standard no later than 180 days after startup of

Boilers No. 6 and No. 7.

(b) To demonstrate initial compliance with the emission limits of PM and HCl, the Permittee must include a signed statement in the Notification of Compliance Status report required in 40 CFR 63.7545(e) that indicates the Permittee burns only liquid fossil fuels other than residual oils, either alone or in combination with gaseous

fuels in Boilers No. 6 and No. 7.

(c) To demonstrate continuous compliance with the emission limits of PM and HCl, the Permittee must keep records that demonstrate that the Permittee burns only liquid fossil fuels other than residual oils, either alone or in combination with gaseous fuels in Boilers No. 6 and No. 7. The Permittee must also include a signed statement in each semiannual compliance report required in 40 CFR 63.7550 thatEli Lilly and Company – Tippecanoe Laboratories Page 13 of 60 Lafayette, Indiana SPM No.:157-22717-00006

Permit Reviewer: Aida De Guzman indicates the Permittee burns only liquid fossil fuels other than residual oils, either alone or in combination with gaseous fuels, during the reporting period.

(d) To demonstrate initial compliance with the work practice standard for CO, the Permittee shall conduct a performance evaluation of the continuous emission monitoring system for carbon monoxide according to 40 CFR 63.7525(a).

(e) To demonstrate continuous compliance with the work practice standard for CO, the Permittee shall meet the requirements of 40 CFR 63.7540(a)(10).

D.20.16 Continuous Emission Monitoring System (CEMS) Requirements [40 CFR 60.13] [40 CFR 60.48b] [40 CFR 63.7525] [40 CFR 63.8] [326 IAC 2-1.1-11] [326 IAC 2-7-24] [326 IAC 3-5] [ 40 CFR 60.48b (e) (2)] [326 IAC 12] [326 IAC 20-1]

(a) NOx CEMS Operation Requirements – The following requirements shall apply to Boilers No. 6 and No. 7 when burning natural gas and/or fuel oil:

(1) The Permittee shall install, calibrate, maintain, evaluate, and operate the NOx CEMS in accordance with the procedures in 40 CFR 60.13 and 40 CFR 60, Appendix F. The span value for the NOx CEMS shall be 500 ppm. If an Alternative Monitoring Plan (AMP) is approved per 40 CFR 60.13(i), then the

conditions in the AMP shall be followed.

(2) The CEMS shall be operational upon startup of the boilers.

(3) Continuous operation is defined as one data point every 15-minute period.

(4) The NOx emissions shall be calculated using stack flow data, or an appropriate F- Factor per 40 CFR 60 Appendix A, Method 19.

(5) The Standard Operating Procedure (S OP) shall include procedures to obtain emission data when nitrogen oxid es emission data are not obtained because of continuous monitoring system breakdowns, repairs, calibration checks and zero and span adjustments. The emission data will be obtained by using standby monitoring systems, Method 7, Method 7A, or other approved reference methods to provide emission data for a minimum of 75 percent of the operating hours in each steam generating unit operating day, in at least 22 out of 30 successive steam generating unit operating days.

(6) The 1-hour average nitrogen oxid es emission rates measured by the continuous nitrogen oxides monitor shall be expressed in lb/MMBTU heat input and shall be used to calculate the average emission rates under 40 CFR 60.44b. The 1-hour averages shall be calculated using the data points required under 40 CFR 60.13(b). At least two data points must be used to calculate each 1-hour average.

(b) CO and O 2 CEMS Operation Requirements – The following requirements shall apply to Boilers No. 6 and No. 7 when burning natural gas and/or fuel oil:

(1) The Permittee shall install, operate, and maintain the CO and O 2 CEMS according to Performance Specification (PS) 4A of 40 CFR part 60, appendix B [40 CFR 63.7525(a)(1)] and according to the site-specific monitoring plan developed according to 40 CFR 63.7505(d). If an Alternative Monitoring Plan (AMP) is approved per 40 CFR 63.8(f), then the conditions in the AMP shall

be met and followed.

(2) The CEMS shall be installed and operational upon startup of the boilers.Eli Lilly and Company – Tippecanoe Laboratories Page 14 of 60 Lafayette, Indiana SPM No.:157-22717-00006

Permit Reviewer: Aida De Guzman

(3) Continuous operation is defined as the collection of at least one measurement for each successive 15-minute period, regardless of startup, shutdown and malfunction. [40 CFR 63.7535(a)(3)]

(4) The 30-day rolling average shall be calculated on a daily basis as the average of all of the hourly averages in the preceding 30 days [40 CFR 63.7525(a)(5).

(5) Data recorded during periods of monitoring malfunctions, associated repairs, out-of-control periods, required quality assurance or control activities, or when the boiler is operating at less than 50 percent of its rated capacity shall not be used to determine compliance. Any period for which the monitoring system is out of control and data are not available for required calculations constitute a deviation from the monitoring requirements. [63.7525(a)(6)]

(c) CEMS Standard Operating Procedures (SOP) – The Permittee shall prepare and implement an SOP that provides step-b y-step procedures and operations in accordance with 326 IAC 3-5-4(a). This includes preventive maintenance procedures and corrective actions that in clude those procedures taken to ensure continuous operation and to minimize malfunctions. The SOP must be submitted to IDEM within 90 days of installation of the monitors.

(d) The commissioner may require stack testing, monitoring, or reporting at any time to assure compliance with all applicable requirements. Any monitoring or testing shall be performed in accordance with 326 IAC 3 or other methods approved by the

commissioner or the U.S. EPA.

Record Keeping and Reporting Requirements [326 IAC 2-7-5(3)] [326 IAC 2-7-19]

D.20.17 Record Keeping Requirements

The Permittee shall maintain the following records:

(a) The records of the carbon monoxide emissions , in tons per month, from Boilers No. 6 and No. 7 and hours of operation of the emergency compressor;

(b) The monthly records of the amount of very low sulfur oil burned in each Boilers No. 6 and No. 7, and the capacity factor of each of Boilers No. 6 and No. 7;

This condition expires when the revisions made to 40 CFR 60 Subpart Db as amended on February 27, 2006, become effective as Indiana law. This condition is not federally enforceable.

(c) Receipts or test analysis for fuel oil burned in Boilers No. 6 and No. 7 certifying that the fuel oil is less than 0.3% sulfur content [40 CFR 60.42b(j), 40 CFR 60.49b(r )];

(d) Daily records of all fuel burned in Boilers No. 6 and No. 7 [40 CFR 60.49b(d), 40 CFR 63.7555(d)(1)];

(e) Annual capacity factor for each fuel burned in Boilers No. 6 and No. 7 calculated monthly using a 12-month rolling average [40 CFR60.49b(d)];

(f) Records of any visual opacity reading of Boilers No. 6 and No. 7. These records must include the date and time of the observations, the results of all readings, and the averages calculated;Eli Lilly and Company – Tippecanoe Laboratories Page 15 of 60 Lafayette, Indiana SPM No.:157-22717-00006

Permit Reviewer: Aida De Guzman This condition expires when the revisions made to 40 CFR 60 Subpart Db as amended on February 27, 2006, become effective as Indiana law. This condition is not federally enforceable.

(g) NOx Emissions data for each of Boilers No. 6 and No. 7 operating day:

(1) Average hourly NOx emissions in lbs/MMBtu [40 CFR 60.49b(g)(2)];

(2) Rolling 30-day average NOx emissions in lbs/MMBtu [40 CFR 60.49b(g)(3)];

(3) Periods when the 30-day NOx average exceeds the limit in D.20.3 [40 CFR 60.49b (g) (4) and 40 CFR 60.49b (h) (4)];

(4) Days when sufficient data was not obtained [40 CFR 60.49b(g)(5)];

(5) Times and reasons for excluding data [40 CFR 60.49b(g)(6)];

(6) Any F factors used to calculate NOx emissions, method of determination, and type of fuel combusted [40 CFR 60.49b(g)(7)];

(7) Times when full span was exceeded [40 CFR 60.49b(g)(8)];

(8) Description of any modifications to th e CEMS that could affect the ability of the system to comply with Performance Standard 2 [40 CFR 60.49b(g)(9)];

and

(9) Results of CEMS daily drift test s and quarterly accuracy assessments [40 CFR 60.49b(g)(10)].

(h) CO Emissions data for Boilers No. 6 and No. 7:

(1) Each period during which a CMS or CEMS on Boilers No. 6 and No.7 is malfunctioning or inoperative (including out-of-control periods) [40 CFR 63.10(b)];

(2) All required measurements needed to demonstrate compliance with the CO standard for Boilers No. 6 and No.7 (including, but not limited to, 15-minute averages of CEMS data, raw performance testing measurements, and raw performance evaluation measurements, that support data that the source is required to report) [40 CFR 63.10(b)];

(3) All results of CEMS performance evaluations [40 CFR 63.10(b)];

(4) All measurements as may be necessary to determine the conditions of performance evaluations [40 CFR 63.10(b)];

(5) All CMS calibration checks [40 CFR 63.10(b)];

(6) All adjustments and maintenance performed on the CEMS [40 CFR 63.10(b)];

(7) Previous (i.e., superseded) versions of the CEMS SOP as required in 40 CFR 63.8(d) (3);

(8) Records of the date and time that each deviation started and stopped, and whether the deviation occurred during a period of startup, shutdown, or malfunction or during another period [40 CFR 63.7555 (a) (5)];Eli Lilly and Company – Tippecanoe Laboratories Page 16 of 60 Lafayette, Indiana SPM No.:157-22717-00006

Permit Reviewer: Aida De Guzman (9) Hourly CO average in ppmdv [63.7525(a)(5)];

(10) 30-day rolling CO average in ppmdv calculated as average of all hourly averages in the 30 day period [63.7525(a)(5)]; and

(11) The boiler hourly emissions shall be computed using the data points required under 40 CFR 63.8(g) and 40 CFR 63.2, appropriate F factors, and/or the emission factors in the paragraphs (ii) and (iii):

(i) 1-hour averages shall be computed from four or more data points equally spaced over each 1-hour period, except during periods when calibration, quality assurance, or maintenance activities are being performed. During these periods, a valid hourly average shall consist of at least two data points with each representing a 15- minute period. Alternatively, an arithmetic or integrated 1-hour average of CEMS data may be used. At least two equally spaced data points must be used to calculate each 1 - hour average; [40 CFR 63.8(g)]

(ii) When burning natural gas: 84 lbs of CO/million cubic feet of gas burned or 12.9 lbs/hr; and

(iii) When burning fuel oil: 5 lbs of CO/thousand gallons of oil or 5.58

lbs/hr.

(i) Records of the operation of T26-GEN-7500A Diesel Powered Emergency Generator in emergency and non-emergency service. Thi s shall include the time of operation and the reason the engine was in operation at that time [40CFR 60.4214(b)].

(j) Pursuant to 40 CFR 63.10(b), the Permittee shall maintain files of all information (including all reports and notifications) required by the general provisions and subpart DDDDD of 40 CFR 63. This subsection is applicable only to Boilers No. 6

and No. 7.

(1) The Permittee shall retain each record for at least 5 years following the date of each occurrence, measurement, maintenance, corrective action, report, or record. The most recent 2 years of records shall be retained at the facility. The remaining 3 years of records may be retained off site;

(2) The Permittee may retain records on microfilm, computer disks, magnetic tape, or microfiche; and

(3) The Permittee shall report required information on paper or on a labeled computer disk.

(k) On and after September 13, 2007, the Permittee shall record the information described in item (1) through (4) below on a calendar month basis for Boiler No. 4,

and Boiler No. 5:

(1) The amount (expressed in thousands of gallons (Mgal)) of No. 2 fuel oil burned in Boilers No. 4 and No. 5;

(2) The average sulfur content (expressed in percentage by weight) of the No. 2 fuel oil burned in Boilers No. 4 and No. 5;

(3) The average higher heating value (expressed in Btu per gallon) of the No. 2 fuel oil burned in Boilers No. 4 and No. 5; andEli Lilly and Company – Tippecanoe Laboratories Page 17 of 60 Lafayette, Indiana SPM No.:157-22717-00006

Permit Reviewer: Aida De Guzman (4) The average sulfur dioxide emission rate (expressed in pounds per MMBtu)

of the No. 2 fuel oil for Boilers No. 4 and No. 5.

D.20.18 Reporting Requirements

(a) A certification shall be submitted to the IDEM, OAQ, stating that only Very Low Sulfur Oil was burned in Boilers No. 6 and No. 7 [40 CFR 60.49b(r)] and a statement that only liquid fossil fuels other than residual oil were burned in Boilers No. 6 and No. 7 [40 CFR 63.7506(a)(2)]. The certification does require the certification by the “responsible official” as defined by 326 IAC 2-7-1(34).

(b) A quarterly summary of the information to document compliance with Conditions D.20.8 (a) and (b) shall be submitted to the IDEM, OAQ, using the reporting forms located at the end of this permit, or their equivalent, within thirty (30) days after the end of the quarter being reported. The report submitted by the Permittee does require the certification by the “responsible official” as defined by 326 IAC 2-7- 1(34).

(c) A quarterly summary of the information to document compliance with Condition D.20.9 and 40 CFR 63.7550(c)(4) shall be submitted to the IDEM, OAQ, using the reporting forms located at the end of this permit, or their equivalent, within thirty (30) days after the end of the quarter being reported. The report submitted by the Permittee does require the certification by the “responsible official” as defined by 326 IAC 2-7-1(34).

(d) The following information shall be reported quarterly:

(1) For Boilers No. 6 and No. 7, all NOx emission records described in D.20.17(g) [40 CFR 60.49b(i)];

(2) A statement that only very low sulfur fuel was burned in Boilers No. 6 and No. 7 [40 CFR 60.49b(r)];

(3) The total fuel used by Boilers No. 6 and No. 7 for each calendar month [40 CFR 63.7550(c) (4)];

(4) A statement that no new fuels were burned in Boilers No. 6 and No. 7 [40 CFR 63.7550(c) (6)];

(5) SSM report as described in 40 CFR 63.10(d)(5)(i) [40 CFR 63.7550(c)(9)];

(6) Description of any deviations occurring in Boilers No. 6 and No. 7 containing the information required by 40 CFR 60.7550 (d) and (e), or a statement that there were none [40 CFR 63.7550(c)(10)];

(7) Description of any CEMS downtime even ts, or a statement that there were none [40 CFR 63.7550(c)(11)];

(8) An excess emissions report for Boilers No. 6 and No. 7 that identifies any opacity excess emissions, the time and date of the visible emission readings and the total time of the visible emission observations for each date, and the total number of hours that oil was burned during each quarter. Excess emissions are any 6-minute period when the average visible emissions exceeded 20%. If oil was not used, then the report shall indicate that fuel oil was not combusted. [40 CFR 60.49b(h)] This condition expires when the revisions made to 40 CFR 60 Subpart Db, as amended on February 27, 2006, become effective as Indiana Law. This condition is notEli Lilly and Company – Tippecanoe Laboratories Page 18 of 60 Lafayette, Indiana SPM No.:157-22717-00006

Permit Reviewer: Aida De Guzman federally enforceable; and

(9) The excess emission report for Boilers No. 6 and No. 7 must provide the calculations showing the annual capacity factor for burning fuel oil at each boiler. [Opacity AMP] This condition expires when the revisions made to 40 CFR 60 Subpart Db, as amended on February 27, 2006, become effective as Indiana Law. This condition is not federally enforceable.

(e) Immediate Reporting Requirements

The reporting requirements in the NESHAP General Provisions for Startup, Shutdown and Malfunction (SSM) Plans [40 CFR 63.6(e)(3)] shall be used to satisfy the reporting requirements under the NESHAP for Industrial, Commercial, and Institutional Boilers and Process Heaters [40 CRF 63.7505(e)].

(1) Any time an action taken by the Permittee during an SSM event of a process is not consistent with the procedures specified in the SSM Plan, the Permittee shall report the actions taken for that event. The immediate report shall be submitted to the IDEM, OAQ via a telephone call or facsimile within 2 working days after commencing actions inconsistent with the plan.

(2) Within 7 working days after the end of an SSM event of a process where an action taken by the Permittee is not consistent with the procedures specified in the SSM Plan, the Permittee shall submit a letter containing the following information in accordance with 40 CFR 63.10(d)(5):

(A) Name, title and signature of responsible official certifying accuracy;

(B) Explanation of the circumstances of the event;

(C) Reason for not following the SSM Plan; and

(D) Report any excess emissions and/or parameter monitoring

exceedances are believed to have occurred.

(f) On and after September 13, 2007, the Permittee shall submit quarterly summary reports of the monthly fuel oil character istic and consumption records required by

Condition D.20.17 for Boilers No. 4 and No. 5.Eli Lilly and Company – Tippecanoe Laboratories Page 19 of 60 Lafayette, Indiana SPM No.:157-22717-00006

Permit Reviewer: Aida De Guzman

D.20.19 Applicability of 40 CFR Part 63 Subpart ZZZZ-National Emission Standards for Hazardous Air Pollutants for Stationary Reciprocating In ternal Combustion Engines (RICE MACT).

The emergency generator or the air compr essor has a site-rating of less than 500 brake horsepower. Therefore, the emergency generator and the air compressor are not subject to the requirements of 40 CFR 63, Subpart ZZZZ (National Emissions Standards for Hazardous Air Pollutants for Stationary Reci procating Internal Combustion Engines).



## INDIANA DEPARTMENT OF ENVIRONMENTAL MANAGEMENT
OFFICE OF AIR QUALITY

COMPLIANCE DATA SECTION

PART 70 OPERATING PERMIT

SEMI-ANNUAL BOILERS NO. 6 and NO. 7 CERTIFICATION

Source Name: Eli Lilly and Company, Tippecanoe Laboratories Source Address: 1650 Lilly Road, Lafayette, Indiana 47909 Mailing Address: 1650 Lilly Road, Lafayette, Indiana 47909

Part 70 Permit No.: T157-6879-00006 Facility: Boilers No. 6 and No.7

Natural Gas Very Low Sulfur Oil

From: To:

I certify that, based on information and belief formed after reasonable inquiry, the statements and information in the document are true, accurate, and complete.

Signature:

Printed Name:

Title/Position:

Phone:

Date:

A certification by the responsible official as defined by 326 IAC 2-7-1(34) is required for this report.Eli Lilly and Company – Tippecanoe Laboratories Page 20 of 60 Lafayette, Indiana SPM No.:157-22717-00006

Permit Reviewer: Aida De Guzman



## INDIANA DEPARTMENT OF ENVIRONMENTAL MANAGEMENT
OFFICE OF AIR QUALITY

COMPLIANCE DATA SECTION

Part 70 Quarterly Report

Source Name: Eli Lilly and Company, Tippecanoe Laboratories Source Address: 1650 Lilly Road, Lafayette, Indiana 47909 Mailing Address: 1650 Lilly Road, Lafayette, Indiana 47909

Part 70 Permit No.: T157-6879-00006 Facility: Boilers No. 6 and No. 7

Parameter: CO

Limit: 98 tons/12 months

Quarter:________________ YEAR:__________

Column 1 Column 2 Column 1 + Column 2

Month

This Month Previous 11 Months 12 Month Total

Month 1

Month 2

Month 3

No deviation occurred in this quarter.

Deviation/s occurred in this quarter. Deviation has been reported on: ___________________________

Submitted by: _____________________________________________

Title / Position:_____________________________________________

Signature:_________________________________________________

Date: _____________________________________________________

Phone: ___________________________________________________

Attach a signed certification to complete this report.Eli Lilly and Company – Tippecanoe Laboratories Page 21 of 60 Lafayette, Indiana SPM No.:157-22717-00006

Permit Reviewer: Aida De Guzman 

## INDIANA DEPARTMENT OF ENVIRONMENTAL MANAGEMENT
OFFICE OF AIR QUALITY

COMPLIANCE DATA SECTION

Part 70 Quarterly Report for First 12 months of Operation

Source Name: Eli Lilly and Company, Tippecanoe Laboratories Source Address: 1650 Lilly Road, Lafayette, Indiana 47909 Mailing Address: 1650 Lilly Road, Lafayette, Indiana 47909

Part 70 Permit No.: T157-6879-00006 Facility: Boilers No. 6 and No. 7

Parameter: CO Limits: (1) 98 ton/12 months (2) Running Monthly Average: 8.17 tons

Quarter:________________ YEAR:__________

Column

1 Column 2 Column 1

+ Column 2 (Column 1 + Column 2) . (Total Months of Operation)

Month This

Month Previous

11 Months *Total Months of Operation Running average up to current month

Month 1

Month 2

Month 3

* When determining the total usage for previous 11 months, assume zero usage during the months when the boilers were not in operation.

No deviation occurred in this quarter.

Deviation/s occurred in this quarter. Deviation has been reported on: ___________________________

Submitted by: _____________________________________________

Title / Position:_____________________________________________

Signature:_________________________________________________

Date: _____________________________________________________

Phone: ___________________________________________________

Attach a signed certification to complete this report.Eli Lilly and Company – Tippecanoe Laboratories Page 22 of 60 Lafayette, Indiana SPM No.:157-22717-00006

Permit Reviewer: Aida De Guzman 

## INDIANA DEPARTMENT OF ENVIRONMENTAL MANAGEMENT
OFFICE OF AIR QUALITY

COMPLIANCE DATA SECTION

Part 70 Quarterly Report

Source Name: Eli Lilly and Company, Tippecanoe Laboratories Source Address: 1650 Lilly Road, Lafayette, Indiana 47909 Mailing Address: 1650 Lilly Road, Lafayette, Indiana 47909

Part 70 Permit No.: T157-6879-00006 Facility: Boiler No. 6 Parameter: Very low sulfur oil and hours fuel oil burned Limit: Less than 976,740 gallons/year = < 10% annual capacity for fuel oil

YEAR:__________

Column 1

This Quarter Column 2

Year Total Column 3 (Column 1 +

Column 2)

Year Total Quarter

No. of gallons No. of

hours No. of gallons No. of

hours No. of gallons No. of

hours Annual Capacity

for fuel oil

Quarter 1 January-March 0.0 0.0

Quarter 2 April-June

Quarter 3 July-September

Quarter 4

OctoberDecember

The boiler‘s maximum capacity to burn fuel oil is 9,767,400 gallons. Annual Capacity = No. of gallons of fuel oil burned up to date for the year /9,767,400 gallons No deviation occurred in this quarter. Deviation/s occurred in this quarter. Deviation has been reported on: ___________________________

Submitted by: _____________________________________________

Title / Position:_____________________________________________

Signature:_________________________________________________

Date: _____________________________________________________

Phone: ___________________________________________________

Attach a signed certification to complete this report.Eli Lilly and Company – Tippecanoe Laboratories Page 23 of 60 Lafayette, Indiana SPM No.:157-22717-00006

Permit Reviewer: Aida De Guzman 

## INDIANA DEPARTMENT OF ENVIRONMENTAL MANAGEMENT
OFFICE OF AIR QUALITY

COMPLIANCE DATA SECTION

Part 70 Quarterly Report

Source Name: Eli Lilly and Company, Tippecanoe Laboratories Source Address: 1650 Lilly Road, Lafayette, Indiana 47909 Mailing Address: 1650 Lilly Road, Lafayette, Indiana 47909

Part 70 Permit No.: T157-6879-00006 Facility: Boiler No. 7 Parameter: Very low sulfur oil and hours fuel oil burned Limit: Less than 976,740 gallons/year = < 10% annual capacity for fuel oil
YEAR:__________

Column 1

This Quarter Column 2

Year Total Column 3 (Column 1 +

Column 2)

Year Total Quarter

No. of gallons No. of

hours No. of gallons No. of

hours No. of gallons No. of

hours Annual Capacity

Quarter 1 January-March 0.0 0.0

Quarter 2 April-June

Quarter 3 July-September

Quarter 4

OctoberDecember

The boiler‘s maximum capacity to burn fuel oil is 9,767,400 gallons. Annual Capacity = No. of gallons of fuel oil burned up to date for the year /9,767,400 gallons No deviation occurred in this quarter. Deviation/s occurred in this quarter. Deviation has been reported on: ___________________________

Submitted by: _____________________________________________

Title / Position:_____________________________________________

Signature:_________________________________________________

Date: _____________________________________________________

Phone: ___________________________________________________

Attach a signed certification to complete this report.Eli Lilly and Company – Tippecanoe Laboratories Page 24 of 60 Lafayette, Indiana SPM No.:157-22717-00006

Permit Reviewer: Aida De Guzman



## INDIANA DEPARTMENT OF ENVIRONMENTAL MANAGEMENT
OFFICE OF AIR QUALITY

COMPLIANCE DATA SECTION

Part 70 Annual Report

Source Name: Eli Lilly and Company, Tippecanoe Laboratories Source Address: 1650 Lilly Road, Lafayette, Indiana 47909 Mailing Address: 1650 Lilly Road, Lafayette, Indiana 47909

Part 70 Permit No.: T157-6879-00006 Facility: Emergency Air Compressor (T26-COMP 5600A) Parameter: Hour of operation

Limit: 500 Hours/year

YEAR:_____________

Hours of Operation

No deviation occurred in quarter.

Deviation/s occurred in this quarter. Deviation has been reported on: ___________________________

Submitted by: _____________________________________________

Title / Position:_____________________________________________

Signature:

_________________________________________________

Date: _____________________________________________________

Phone: ___________________________________________________

Attach a signed certification to complete this report.

(8) Condition C.5 has been deleted, since a requirement to operate emission controlequipment has been added in SECTION Ds. Subsequent conditions have been renumbered accordingly:

C.5 Operation of Equipment [326 IAC 2

- 7

- 6(6)]

Except as otherwise provided by statute or rule, or in this perm it, all air pollution control equipment listed in this permit and used to comply with an applicable requirement shall be operated at all times that the emission units vented to the control equipment is in operation.Eli Lilly and Company – Tippecanoe Laboratories Page 25 of 60 Lafayette, Indiana SPM No.:157-22717-00006

Permit Reviewer: Aida De Guzman (9) Diesel generator (Gen-7001), which is an insignificant activity, has been added in Section D.2(b) as the source requested:

(b) The following emission units are not subject to applicable requirements described in this D section and are listed only for informational purposes:

Emission

Unit ID Emission Unit Description Stack/Vent Nominal Capacity UOM Control Device

Building T5:

T5* Diesel Generator 

### N/A 380 HP None

Portable Units:

T62* Diesel Generator N/A 1100 KW None

T135* Diesel Generator N/A 390 HP None
T78* Diesel Compressor N/A 58 KW None
T89-1* Diesel Compressor N/A 58 KW None
T89-2* Diesel Compressor N/A 58 KW None

Building T97/T98:

T97/T98* Glycol System N/A 45,000 gallon None

Building T9/T23:

T9/T23* Lime Storage Silo N/A 79.5 lb/hr None

Building T70 :

Gen-7001* Diesel Generator N/A 300 KW None

* Emission units marked with a single asterisk are insi gnificant activities as def ined in 326 IAC 2-7-1(21).

(10) The following condition has been added and numbered D.5.9 under Compliance Determination Section, since C.5, Operat ion of Equipment has been deleted from the permit. Subsequent conditions have been re-numbered accordingly:

Compliance Determination Requirements

D.5.9 Operation of Control Equipment [326 IAC 2-7-6(6)]

Except as otherwise provided by statute or rule , or in this permit, the Iron Sponge Reactor shall be operated at all times that the emissi on units vented to the Iron Sponge Reactor are in operation.

(11) An administrative amendment application has been submitted to IDEM, OAQ on February 27, 2006. However, an amendment has never been issued. The following were the requests, which will be included in this proposed significant permit modification:

(a) Remove T27-RVD53-1. This process unit has been removed. (b) Remove T27-IBC8202. This process unit has been removed. (c) Remove T27-IBC8208. This process unit has been removed. (d) Remove T27-IBC8210. This process unit has been removed. (e) Remove T27-IBC8252. This process unit has been removed. (f) Remove T27-IBC8255. This process unit has been removed. (g) Remove T27-IBC8258. This process unit has been removed. (h) Add T99-FD-9D. This is an insignificant activity. (i) Add T99-D-9D. This is an insignificant activity.

(j) Add T99-D-9B. This is an insignificant activity.Eli Lilly and Company – Tippecanoe Laboratories Page 26 of 60 Lafayette, Indiana SPM No.:157-22717-00006

Permit Reviewer: Aida De Guzman (k) Add T100-Tk5C. This is an insignificant activity. (l) Add T100-Tk18A. This is an insignificant activity. (m) Add T100-TK18B. This is an insignificant activity. (n) Add T100-TK24D. This is an insignificant activity. (o) Remove T100 Portable Process Tank. This process unit has been removed.

SECTION D.6 BULK PHARMACEUTICAL MANUF ACTURING (BPM) PRODUCTION OPERATIONS

Facility description [326 IAC 2-7-5(15)]

The information describing the processes contained in the facility description boxes is descriptive

information and does not constitute enforceable conditions:

(a) The emission units listed below are subject to applicable requirements described or referred to in this D section. The emission units in the BPM production operations can be generally described as process vessels (tanks), crystallizers, filters, centrifuges, dryers, process scrubber systems, and process condenser systems and are referred to as process vents under the National Emission
Standards of Hazardous Air Pollutants for Pharma ceutical Production Operations (Pharmaceutical MACT) found at 40 CFR Part 63, Subpart GGG.

General activities such as open manway operati ons, charging a liquid from a drum to a tank, centrifuge emptying operations, drum filling operati ons, or loading wetcake into driers are also defined as process vents. Individual identificat ion of these activities are not listed in the description tables given they are not stationary or continually change. Each of these activity types will follow the compliance requirements outlined in this permit section.

Ancillary activities, such as heat exchange systems, are not considered process vents and have not been included in the description tables.

Source ID Equipment Description Stack/V ent ID Nominal Capacity Control Device

Building T27:

T27-TK30-1 Process Tank RTO 200 gal RTO
T27-TK30-2 Process Tank RTO 200 gal RTO
T27-TK31-1 Process Tank RTO 1000 gal RTO
T27-TK31-2 Process Tank RTO 1000 gal RTO
T27-TK31-3 Process Tank RTO 1000 gal RTO
T27-TK31-4 Process Tank RTO 1000 gal RTO
T27-TK31-5 Process Tank RTO 1000 gal RTO
T27-TK32-1 Process Tank RTO 1000 gal RTO
T27-TK32-2 Process Tank RTO 1000 gal RTO
T27-TK32-3 Process Tank RTO 1000 gal RTO
T27-TK32-4 Process Tank RTO 1000 gal RTO
T27-TK32-5 Process Tank RTO 1000 gal RTO
T27-TK32-6 Process Tank RTO 1000 gal RTO
T27-TK32-7 Process Tank RTO 350 gal RTO
T27-TK33-1 Process Tank RTO 2000 gal RTO
T27-TK33-2 Process Tank RTO 2000 gal RTO
T27-TK33-3 Process Tank RTO 2000 gal RTO
T27-TK33-4 Process Tank RTO 2000 gal RTO
T27-TK33-5 Process Tank RTO 500 gal RTO
T27-TK33-6 Process Tank RTO 1000 gal RTO
T27-TK34-1 Process Tank RTO 750 gal RTOEli Lilly and Company – Tippecanoe Laboratories Page 27 of 60 Lafayette, Indiana SPM No.:157-22717-00006

Permit Reviewer: Aida De Guzman

Source ID Equipment Description Stack/V ent ID Nominal Capacity Control Device

T27-TK34-2 Process Tank RTO 750 gal RTO
T27-TK34-4 Process Tank RTO 750 gal RTO
T27-TK34-5 Process Tank RTO 750 gal RTO
T27-TK34-6 Process Tank RTO 750 gal RTO
T27-TK34-7 Process Tank RTO 1000 gal RTO
T27-TK34-8 Process Tank RTO 350 gal RTO
T27-TK35-1 Process Tank RTO 2000 gal RTO
T27-TK35-2 Process Tank RTO 2000 gal RTO
T27-TK35-3 Process Tank RTO 2000 gal RTO
T27-TK35-4 Process Tank RTO 2000 gal RTO
T27-TK35-5 Process Tank RTO 500 gal RTO
T27-TK35-6 Process Tank RTO 2000 gal RTO
T27-TK35-10B Process Tank RTO 1000 gal RTO
T27-TK36-1 Process Tank RTO 2000 gal RTO
T27-TK36-2 Process Tank RTO 1000 gal RTO
T27-TK36-3 Process Tank RTO 2000 gal RTO
T27-TK36-6 Process Tank RTO 2000 gal RTO
T27-TK36-7 Process Tank RTO 500 gal RTO
T27-TK37-2A Process Tank RTO 300 gal RTO
T27-TK38-3 Process Tank RTO 1000 gal RTO
T27-TK40-1 Process Tank RTO 2000 gal RTO
T27-TK40-2 Process Tank RTO 2000 gal RTO
T27-TK40-4 Process Tank RTO 1000 gal RTO
T27-TK40-5 Process Tank RTO 1500 gal RTO
T27-TK40-6 Process Tank RTO 2000 gal RTO
T27-TK40-6A Process Tank RTO 2000 gal RTO
T27-TK40-7 Process Tank RTO 2000 gal RTO
T27-TK40-7A Process Tank RTO 2000 gal RTO
T27-TK40-8 Process Tank RTO 2000 gal RTO
T27-TK40-9 Process Tank RTO 1000 gal RTO
T27-TK40-10 Process Tank RTO 1000 gal RTO
T27-TK40-11 Process Tank RTO 1000 gal RTO
T27-TK40-13 Process Tank RTO 750 gal RTO
T27-TK40-14 Process Tank RTO 300 gal RTO
T27-TK40-31 Process Tank RTO 500 gal RTO
T27-TK41-1 Process Tank RTO 750 gal RTO
T27-TK41-3 Process Tank RTO 500 gal RTO
T27-TK41-4 Process Tank RTO 500 gal RTO
T27-TK41-5 Process Tank RTO 1000 gal RTO
T27-TK41-6 Process Tank RTO 300 gal RTO
T27-TK42-3 Process Tank RTO 500 gal RTO
T27-TK42-5 Process Tank RTO 1000 gal RTO
T27-TK43-1 Process Tank RTO 750 gal RTO
T27-TK43-2 Process Tank RTO 500 gal RTO
T27-TK44-1 Process Tank RTO 2000 gal RTO
T27-TK44-4 Process Tank RTO 2000 gal RTO
T27-TK45-2 Process Tank RTO 1000 gal RTO
T27-TK45-3 Process Tank RTO 1000 gal RTOEli Lilly and Company – Tippecanoe Laboratories Page 28 of 60 Lafayette, Indiana SPM No.:157-22717-00006

Permit Reviewer: Aida De Guzman

Source ID Equipment Description Stack/V ent ID Nominal Capacity Control Device

T27-TK46-1 Process Tank RTO 1000 gal RTO
T27-TK46-5 Process Tank RTO 1000 gal RTO
T27-TK47-1 Process Tank RTO 1000 gal RTO
T27-TK47-2 Process Tank RTO 550 gal RTO
T27-TK47-3 Process Tank RTO 1000 gal RTO
T27-TK47-5 Process Tank RTO 300 gal RTO
T27-TK48-1 Process Tank RTO 300 gal RTO
T27-TK48-1A Process Tank RTO 1000 gal RTO
T27-TK48-2A Process Tank RTO 100 gal RTO
T27-TK48-3A Process Tank RTO 500 gal RTO
T27-TK49-1 Process Tank RTO 200 gal RTO
T27-TK50-1 Process Tank RTO 650 gal RTO
T27-TK50-2 Process Tank RTO 150 gal RTO
T27-TK50-3 Process Tank RTO 150 gal RTO
T27-TK50-4 Process Tank RTO 500 gal RTO
T27-TK372-A Process Tank RTO 500 gal RTO
T27-CENT9 Centrifuge RTO NA RTO
T27-CENT16 Centrifuge RTO NA RTO
T27-CENT19 Centrifuge RTO NA RTO
T27-CENT30 Centrifuge RTO NA RTO
T27-CENT37 Centrifuge RTO NA RTO
T27-CENT38 Centrifuge RTO NA RTO
T27-CENT40 Centrifuge RTO NA RTO

T27-DT46-1 Process Tank RTO RTO

T2 7

- RVD53

- 1 Process Dryer RTO NA RTO
T27-RVD53-2 Process Dryer RTO NA RTO

T27-SCR30-4 Process Scrubber RTO NA RTO

T27-SCR33-7 Process Scrubber RTO NA RTO

T27-SCR34-9 Process Scrubber RTO NA RTO

T27-SCR35-10A Process Scrubber RTO NA RTO

T27-SCR35-10B Process Scrubber RTO NA RTO

T27-VC31-1 Process Condenser RTO NA RTO

T27-VC32-1 Process Condenser RTO NA RTO

T27-VC32-2 Process Condenser RTO NA RTO

T27-VC32-3 Process Condenser RTO NA RTO

T27-VC33-1 Process Condenser RTO NA RTO

T27-VC33-2 Process Condenser RTO NA RTO

T27-VC33-3 Process Condenser RTO NA RTO

T27-VC33-4 Process Condenser RTO NA RTO

T27-VC35-1 Process Condenser RTO NA RTO

T27-VC35-2 Process Condenser RTO NA RTO

T27-VC35-4 Process Condenser RTO NA RTO

T27-VC36-1 Process Condenser RTO NA RTO

T27-VC36-2 Process Condenser RTO NA RTO

T27-VC36-3 Process Condenser RTO NA RTO

T27-VC40 Process Condenser RTO NA RTO

T27-VC40-2 Process Condenser RTO NA RTO

T27-VC40-5 Process Condenser RTO NA RTOEli Lilly and Company – Tippecanoe Laboratories Page 29 of 60 Lafayette, Indiana SPM No.:157-22717-00006

Permit Reviewer: Aida De Guzman

Source ID Equipment Description Stack/V ent ID Nominal Capacity Control Device

T27-VC40-7A Process Condenser RTO NA RTO

T27-VC43-1 Process Condenser RTO NA RTO

T27-VC44-4 Process Condenser RTO NA RTO

T27-VC45-2 Process Condenser RTO NA RTO

T27-VC46-1 Process Condenser RTO NA RTO

T27-VC47-1 Process Condenser RTO NA RTO

T27-VC48-1 Process Condenser RTO NA RTO

T27-VC48-1A Process Condenser RTO NA RTO

T27-VC49-1 Process Condenser RTO NA RTO

T27-VC50-1 Process Condenser RTO NA RTO

T27-VC53-1 Process Condenser RTO NA RTO

T27-VC53-2 Process Condenser RTO NA RTO

T27-VC53-10 Process Condenser RTO NA RTO

T27-PORTVC Portable Process
Condenser RTO NA RTO

Building T28:

T28-CENT1 Heinkel Centrifuge RTO NA RTO
T28-CENT2 Heinkel Centrifuge RTO NA RTO
T28-CENT3 Heinkel Centrifuge RTO NA RTO
T28-CENT15 Centrifuge RTO NA RTO
T28-CENT22 Centrifuge RTO NA RTO
T28-CENT24 Centrifuge RTO NA RTO
T28-CENT26 Centrifuge RTO NA RTO
T28-TK28-1 Process Tank RTO 2000 gal RTO
T28-TK28-1A Process Tank RTO 300 gal RTO
T28-TK28-2 Process Tank RTO 1000 gal RTO
T28-TK28-3 Process Tank RTO 2000 gal RTO
T28-TK28-3A Process Tank RTO 340 gal RTO
T28-TK28-03 Process Tank RTO 2000 gal RTO
T28-TK28-4 Process Tank RTO 1000 gal RTO
T28-TK28-5 Process Tank RTO 1000 gal RTO
T28-TK28-6 Process Tank RTO 1000 gal RTO
T28-TK28-7 Process Tank RTO 2000 gal RTO
T28-TK28-8 Process Tank RTO 2000 gal RTO
T28-TK28-9 Process Tank RTO 1000 gal RTO
T28-TK28-10 Process Tank RTO 2000 gal RTO
T28-TK28-10A Process Tank RTO 340 gal RTO
T28-TK28-11 Process Tank RTO 2000 gal RTO
T28-TK28-12 Process Tank RTO 2000 gal RTO
T28-TK28-13 Process Tank RTO 2000 gal RTO
T28-TK28-14 Process Tank RTO 2000 gal RTO
T28-TK28-15 Process Tank RTO 2000 gal RTO
T28-TK28-16 Process Tank RTO 2000 gal RTO
T28-TK28-17 Process Tank RTO 1000 gal RTO
T28-TK28-18 Process Tank RTO 750 gal RTO
T28-TK28-19 Process Tank RTO 2000 gal RTO
T28-TK28-20 Process Tank RTO 2000 gal RTOEli Lilly and Company – Tippecanoe Laboratories Page 30 of 60 Lafayette, Indiana SPM No.:157-22717-00006

Permit Reviewer: Aida De Guzman

Source ID Equipment Description Stack/V ent ID Nominal Capacity Control Device

T28-TK28-21 Process Tank RTO 2000 gal RTO
T28-TK28-22 Process Tank RTO 2000 gal RTO
T28-TK28-23 Process Tank RTO 2000 gal RTO
T28-TK28-24 Process Tank RTO 2000 gal RTO
T28-TK28-25 Process Tank RTO 1500 gal RTO
T28-TK28-26 Process Tank RTO 1500 gal RTO
T28-TK28-27 Process Tank RTO 140 gal RTO
T28-TK28-29 Process Tank RTO 1000 gal RTO
T28-TK28-30 Process Tank RTO 500 gal RTO
T28-TK28-31 Process Tank RTO 2000 gal RTO
T28-TK28-32 Process Tank RTO 2000 gal RTO
T28-PTK1 Portable Charge Tank RTO 300 gal RTO
T28-PTK2 Portable Charge Tank RTO 300 gal RTO
T28-PTK3 Portable Charge Tank RTO 300 gal RTO

T28-SCR1 Process Scrubber RTO NA RTO

T28-SCR2 Process Scrubber RTO NA RTO

T28-SCR3 Process Scrubber RTO NA RTO

T28-SCR4 Process Scrubber RTO NA RTO

T28-SCR6 Process Scrubber RTO NA RTO
T28-SCRTK1 Scrubber Tank RTO 300 gal RTO
T28-SCRTK2 Scrubber Tank RTO 500 gal RTO
T28-SCRTK4 Scrubber Tank RTO 500 gal RTO

T28-VC28-1 Process Condenser RTO NA RTO

T28-VC28-3 Process Condenser RTO NA RTO

T28-VC28-4 Process Condenser RTO NA RTO

T28-VC28-5 Process Condenser RTO NA RTO

T28-VC28-6 Process Condenser RTO NA RTO

T28-VC28-8 Process Condenser RTO NA RTO

T28-VC28-10 Process Condenser RTO NA RTO

T28-VC28-11 Process Condenser RTO NA RTO

T28-VC28-12 Process Condenser RTO NA RTO

Building T29:

T29-CENT1401 Heinkel Centrifuge RTO 70 gal RTO
T29-CENT2401 Heinkel Centrifuge RTO 70 gal RTO
T29-CENT3401 Heinkel Centrifuge RTO 70 gal RTO
T29-DRY1501 Cone Dryer RTO 580 gal RTO
T29-DRY2402 Filter Dryer RTO 863 gal RTO
T29-DRY2502 Filter Dryer RTO 863 gal RTO
T29-DRY3501 Cone Dryer RTO 580 gal RTO
T29-IBC8201 Process Tank RTO 100 gal RTO

T29

- IBC8202 Process Tank RTO 150 gal RTO
T29-IBC8203 Process Tank RTO 150 gal RTO
T29-IBC8204 Process Tank RTO 150 gal RTO
T29-IBC8205 Process Tank RTO 150 gal RTO
T29-IBC8206 Process Tank RTO 150 gal RTO
T29-IBC8207 Process Tank RTO 150 gal RTO

T29

- IBC8208 Process Tank RTO 150 gal RTOEli Lilly and Company – Tippecanoe Laboratories Page 31 of 60 Lafayette, Indiana SPM No.:157-22717-00006

Permit Reviewer: Aida De Guzman

Source ID Equipment Description Stack/V ent ID Nominal Capacity Control Device

T29-IBC8209 Process Tank RTO 150 gal RTO

T29

- I BC8210 Process Tank RTO 150 gal RTO
T29-IBC8216 Process Tank RTO 50 gal RTO
T29-IBC8217 Process Tank RTO 50 gal RTO
T29-IBC8251 Process Tank RTO 150 gal RTO

T29

- IBC8252 Process Tank RTO 150 gal RTO
T29-IBC8253 Process Tank RTO 150 gal RTO
T29-IBC8254 Process Tank RTO 150 gal RTO

T29

- IBC8255 Process Tank RTO 150 gal RTO
T29-IBC8256 Process Tank RTO 150 gal RTO
T29-IBC8257 Process Tank RTO 150 gal RTO

T29

- IBC8258 Process Tank RTO 150 gal RTO
T29-IBC8259 Process Tank RTO 150 gal RTO
T29-IBC8380 Process Tank RTO 50 gal RTO
T29-IBC8381 Process Tank RTO 50 gal RTO

T29-SFH1121 Process Tank RTO NA RTO

T29-SFH3121 Process Tank RTO NA RTO
T29-TK1201 Process Tank RTO 2000 gal RTO
T29-TK1202 Process Tank RTO 2000 gal RTO
T29-TK1203 Process Tank RTO 2000 gal RTO
T29-TK1204 Process Tank RTO 2000 gal RTO
T29-TK1205 Process Tank RTO 2000 gal RTO
T29-TK2201 Process Tank RTO 1600 gal RTO
T29-TK2202 Process Tank RTO 2000 gal RTO
T29-TK2203 Process Tank RTO 2000 gal RTO
T29-TK2204 Process Tank RTO 2000 gal RTO
T29-TK2205 Process Tank RTO 2000 gal RTO
T29-TK3201 Process Tank RTO 2000 gal RTO
T29-TK3202 Process Tank RTO 2000 gal RTO
T29-TK3203 Process Tank RTO 2000 gal RTO
T29-TK3204 Process Tank RTO 2000 gal RTO
T29-TK3205 Process Tank RTO 2000 gal RTO
T29-TK4201 Process Tank RTO 1600 gal RTO
T29-TK4203 Process Tank RTO 2000 gal RTO
T29-TK7920 Process Tank RTO 200 gal RTO
T29-TK7921 Process Tank RTO 80 gal RTO
T29-TK8211 Process Tank RTO 100 gal RTO
T29-TK8212 Process Tank RTO 100 gal RTO
T29-TK8213 Process Tank RTO 100 gal RTO
T29-TK8214 Process Tank RTO 100 gal RTO
T29-TK8216 Process Tank RTO 50 gal RTO
T29-TK8218 Process Tank RTO 50 gal RTO
T29-TK8220 Process Tank RTO 50 gal RTO

T29-TK8501 Process Tank RTO 0.75 sf RTO

T29-HE1201 Process Condenser RTO NA RTO

T29-HE1202 Process Condenser RTO NA RTO

T29-HE1203 Process Condenser RTO NA RTO

T29-HE1204 Process Condenser RTO NA RTOEli Lilly and Company – Tippecanoe Laboratories Page 32 of 60 Lafayette, Indiana SPM No.:157-22717-00006

Permit Reviewer: Aida De Guzman

Source ID Equipment Description Stack/V ent ID Nominal Capacity Control Device

T29-HE1205 Process Condenser RTO NA RTO

T29-HE2201 Process Condenser RTO NA RTO

T29-HE2202 Process Condenser RTO NA RTO

T29-HE2203 Process Condenser RTO NA RTO

T29-HE2204 Process Condenser RTO NA RTO

T29-HE2205 Process Condenser RTO NA RTO

T29-HE3201 Process Condenser RTO NA RTO

T29-HE3202 Process Condenser RTO NA RTO

T29-HE3203 Process Condenser RTO NA RTO

T29-HE3204 Process Condenser RTO NA RTO

T29-HE3205 Process Condenser RTO NA RTO

T29-HE4201 Process Condenser RTO NA RTO

T29-HE4203 Process Condenser RTO NA RTO

T29-TK1203A A ccumulator Tank RTO 70 gal RTO

T29-TK1204A A ccumulator Tank RTO 70 gal RTO

T29-TK1401A A ccumulator Tank RTO 70 gal RTO

T29-TK2401A A ccumulator Tank RTO 70 gal RTO

T29-TK3401A A ccumulator Tank RTO 70 gal RTO

T29-TK4201A A ccumulator Tank RTO 70 gal RTO

T29-SCR1601 Process Scrubber RTO NA RTO

T29-SCR2601 Process Scrubber RTO NA RTO

T29-SCR3601 Process Scrubber RTO NA RTO

Building T31:

T31-CENT Centrifuge RTO 13 cf RTO
T31-CENT504 Centrifuge RTO 13 gal RTO

T31-FD803 Filter Dryer RTO 0.6 m 2 RTO
T31-TK601 Process Tank RTO 500 gal RTO
T31-TK602 Process Tank RTO 500 gal RTO
T31-TK603 Process Tank RTO 500 gal RTO
T31-TK604 Process Tank RTO 500 gal RTO
T31-TK611 Process Tank RTO 500 gal RTO
T31-TK611DT01 Process Tank RTO 50 gal RTO
T31-TK612 Process Tank RTO 500gal RTO
T31-TK613 Process Tank RTO 500 gal RTO
T31-TK614 Process Tank RTO 500 gal RTO
T31-TK631 Process Tank RTO 300 gal RTO
T31-TK641 Process Tank RTO 100 gal RTO
T31-TK643 Process Tank RTO 100 gal RTO

T31-HE501 Process Condenser RTO N/A RTO

T31-HE503 Process Condenser RTO N/A RTO

T31-HE511 Process Condenser RTO N/A RTO

T31-HE512 Process Condenser RTO N/A RTO

T31-HE531 Process Condenser RTO N/A RTO

T31-HE541 Process Condenser RTO N/A RTO

T31-SCR-OZ Process Scrubber (Ozone) RTO N/A RTO
T31-SCR721 Process Scrubber RTO 200 gal RTOEli Lilly and Company – Tippecanoe Laboratories Page 33 of 60 Lafayette, Indiana SPM No.:157-22717-00006

Permit Reviewer: Aida De Guzman

Source ID Equipment Description Stack/V ent ID Nominal Capacity Control Device

Building T31A:

T31A-CENT981 Centrifuge RTO N/A RTO
T31A-FD861 Filter Dryer RTO 0.6 m2 RTO
T31A-FD874 Filter Dryer RTO 0.6 m2 RTO
T31A-RVD881 Dryer RTO 100 cf RTO
T31A-RVD891 Dryer RTO 100 cf RTO
T31A-DT683 Drowning Tank 001 RTO NA RTO
T31A-TK621 Process Tank RTO 300 gal RTO
T31A-TK622 Process Tank RTO 800 gal RTO
T31A-TK623 Process Tank RTO 400 gal RTO
T31A-TK624 Process Tank RTO 300 gal RTO
T31A-TK625 Process Tank RTO 300 gal RTO
T31A-TK626 Process Tank RTO 500 gal RTO
T31A-TK651 Process Tank RTO 450 gal RTO
T31A-TK661 Process Tank RTO 300 gal RTO
T31A-TK681 Process Tank RTO 500 gal RTO
T31A-TK682 Process Tank RTO 500 gal RTO
T31A-TK683 Process Tank RTO 500 gal RTO
T31A-TK684 Process Tank RTO 500 gal RTO
T31A-TK691 Process Tank RTO 500 gal RTO
T31A-TK692 Process Tank RTO 500 gal RTO
T31A-TK693 Process Tank RTO 500 gal RTO
T31A-TK694 Process Tank RTO 500 gal RTO
T31A-TK861K Process Tank RTO 50 gal RTO

T31A-HE481 Process Condenser RTO N/A RTO

T31A-HE482 Process Condenser RTO N/A RTO

T31A-HE491 Process Condenser RTO N/A RTO

T31A-HE492 Process Condenser RTO N/A RTO

T31A-HE521 Process Condenser RTO N/A RTO

T31A-HE551 Process Condenser RTO N/A RTO

T31A-HE561 Process Condenser RTO N/A RTO

T31A-HE581 Process Condenser RTO N/A RTO

T31A-HE583 Process Condenser RTO N/A RTO

T31A-HE591 Process Condenser RTO N/A RTO

T31A-HE593 Process Condenser RTO N/A RTO

T31A-HE781 Process Condenser RTO N/A RTO

T31A-HE791 Process Condenser RTO N/A RTO

T31A-SCR261 Process Scrubber RTO N/A RTO

T31A-SCR262 Process Scrubber RTO N/A RTO
T31A-SCR781 Process Scrubber RTO 200 gal RTO
T31A-SCR791 Process Scrubber RTO 500 gal RTO
T31A-SCRTK781 Process Scrubber Tank RTO 300 gal RTO
T31A-SCRTK791 Process Scrubber Tank RTO 300 gal RTO

Building T99:

T99-CENT Heinkel Centrifuge RTO NA RTO
T99-PD43 Pan Dryer RTO 528 gal RTOEli Lilly and Company – Tippecanoe Laboratories Page 34 of 60 Lafayette, Indiana SPM No.:157-22717-00006

Permit Reviewer: Aida De Guzman

Source ID Equipment Description Stack/V ent ID Nominal Capacity Control Device

T99-PD44 Pan Dryer RTO 528 gal RTO
T99-RVD1 Rotary Vacuum Dryer RTO 1200 gal RTO
T99-RVD2 Rotary Vacuum Dryer RTO 1200 gal RTO
T99-RVD3 Rotary Vacuum Dryer RTO 1200 gal RTO
T99-RVD5 Rotary Vacuum Dryer RTO 1200 gal RTO
T99-RVD6 Rotary Vacuum Dryer RTO 1200 gal RTO
T99-RVD7 Rotary Vacuum Dryer RTO 1200 gal RTO
T99-RVD8 Rotary Vacuum Dryer RTO 1200 gal RTO
T99-FD-9D* Filter Dryer RTO NA RTO
T99-D-9D* Portable Tank RTO 155 gal RTO T99-D-9B* Condensate Tank RTO 10 gal RTO T99-TK-D41 Process Tank RTO 300 gal RTO
T99-TK-D42 Process Tank RTO 150 gal RTO

T99-HE43 Process Condenser RTO NA RTO

T99-HE44 Process Condenser RTO NA RTO

Building T100:

T100-CENT60 Centrifuge RTO N/A RTO
T100-CENT61 Centrifuge RTO N/A RTO
T100-CENT62 Centrifuge RTO N/A RTO
T100-CENT63 Centrifuge RTO N/A RTO
T100-CENT64 Centrifuge RTO N/A RTO
T100-CENT65 Centrifuge RTO N/A RTO
T100-CENT66 Centrifuge RTO N/A RTO
T100-CENT67 Centrifuge RTO N/A RTO
T100-CENT68 Centrifuge RTO N/A RTO
T100-CENT69 Centrifuge RTO N/A RTO
T100-CENT70 Centrifuge RTO N/A RTO
T100-TK1 Process Tank RTO 2000 gal RTO

T100-TK1C Process Tank RTO N/A RTO
T100-TK2 Process Tank RTO 4000 gal RTO
T100-TK3 Process Tank RTO 2000 gal RTO
T100-TK4 Process Tank RTO 2000 gal RTO
T100-TK5 Process Tank RTO 2000 gal RTO
T100-Tk5C* Accumulator Tank RTO 50 gal RTO T100-TK6 Process Tank RTO 2000 gal RTO
T100-TK7 Process Tank RTO 4000 gal RTO
T100-TK8 Process Tank RTO 4000 gal RTO
T100-TK8C Process Tank RTO 30 gal RTO
T100-TK9 Process Tank RTO 4000 gal RTO
T100-TK10 Process Tank RTO 4000 gal RTO
T100-TK11 Process Tank RTO 4000 gal RTO
T100-TK12 Process Tank RTO 4000 gal RTO

T100-TK13 Process Tank RTO 3300 Gal RTO
T100-TK14 Process Tank RTO 4000 gal RTO
T100-TK15 Process Tank RTO 2000 gal RTO
T100-TK16 Process Tank RTO 2000 gal RTO
T100-TK17 Process Tank RTO 2000 gal RTOEli Lilly and Company – Tippecanoe Laboratories Page 35 of 60 Lafayette, Indiana SPM No.:157-22717-00006

Permit Reviewer: Aida De Guzman

Source ID Equipment Description Stack/V ent ID Nominal Capacity Control Device

T100-TK18 Process Tank RTO 2000 gal RTO
T100-TK18A* Distillate Tank RTO 200 gal RTO
T100-TK18B* Charge Tank RTO 60 gal RTO T100-TK20 Process Tank RTO 4000 gal RTO
T100-TK21 Process Tank RTO 4000 gal RTO
T100-TK22 Process Tank RTO 2000 gal RTO
T100-TK24 Process Tank RTO 4000 gal RTO
T100-TK24D* Distillate Tank RTO 50 gal RTO T100-TK25 Process Tank RTO 4000 gal RTO
T100-TK26 Process Tank RTO 4000 gal RTO
T100-TK27 Process Tank RTO 4000 gal RTO
T100-TK28 Process Tank RTO 4000 gal RTO
T100-TK29 Process Tank RTO 4000 gal RTO
T100-TK30 Process Tank RTO 4000 gal RTO
T100-TK-30A Process Tank RTO 70 gal RTO
T100-TK31 Process Tank RTO 4000 gal RTO
T100-TK31B Process Tank RTO 50 gal RTO
T100-TK32 Process Tank RTO 4000 gal RTO
T100-TK33 Process Tank RTO 1000 gal RTO
T100-TK34 Process Tank RTO 1000 gal RTO
T100-TK35 Process Tank RTO 1000 gal RTO
T100-TK36 Process Tank RTO 1000 gal RTO
T100-TK37 Process Tank RTO 1000 gal RTO
T100-TK38 Process Tank RTO 1000 gal RTO

T100 Portable Process Tank RTO N/A RTO

T100 Portable Process Tank RTO N/A RTO T100-PTK1 Portable Cleaning Tank RTO 150 gal RTO

T100-HE1 Process Condenser RTO N/A RTO

T100-HE1C Process Condenser N/A

T100-HE2 Process Condenser RTO N/A RTO

T100-HE4 Process Condenser RTO N/A RTO

T100-HE6 Process Condenser RTO N/A RTO

T100-HE7 Process Condenser RTO N/A RTO

T100-HE8 Process Condenser RTO N/A RTO

T100-HE11 Process Condenser RTO N/A RTO

T100-HE12 Process Condenser RTO N/A RTO

T100-HE13 Process Condenser RTO N/A RTO

T100-HE14 Process Condenser RTO N/A RTO

T100-HE14B Process Condenser RTO N/A RTO

T100-HE16 Process Condenser RTO N/A RTO

T100-HE21A Process Condenser RTO N/A RTO

T100-HE21B Process Condenser RTO N/A RTO

T100-HE26 Process Condenser RTO N/A RTO

T100-HE28 Process Condenser RTO N/A RTO

T100-HE31 Process Condenser RTO N/A RTO

T100-TK14A A ccumulator Tank RTO 50 gal RTO

T100-TK21A A ccumulator Tank RTO 50 gal RTO
T100-TK39 CIP Tank RTO 500 gal RTOEli Lilly and Company – Tippecanoe Laboratories Page 36 of 60 Lafayette, Indiana SPM No.:157-22717-00006

Permit Reviewer: Aida De Guzman

Source ID Equipment Description Stack/V ent ID Nominal Capacity Control Device

T100-SCR80 Process Scrubber RTO N/A RTO

T100-SCR81 Process Scrubber RTO N/A RTO

T100-SCR82 Process Scrubber RTO N/A RTO

T100-SCR83 Process Scrubber RTO N/A RTO

T100-SCR84 Process Scrubber RTO N/A RTO

T100-SCR85 Process Scrubber RTO N/A RTO
T100-TK82 Scrubber Holding Tank RTO 1000 gal RTO
T100-TK83 Scrubber Holding Tank RTO 1000 gal RTO
T100-TK84 Scrubber Holding Tank RTO 1000 gal RTO
T100-TK85 Scrubber Holding Tank RTO 1000 gal RTO

* Emission units marked with a single asterisk are in significant activities as defined in 326 IAC 2-7-1(21).

(12) The Permittee has requested the following change to Condition D.6.1, to avoid reporting multiple deviations from conditions that are interrelated. With this change, emission control requirements that control the entir e plant bulk production manufacturing operations
are consolidated in SECTION D.14 and SECTION D.15:

D.6.1 Standards for BPM Process Vents [40 CFR 63.1254, 326 IAC 2-2-3, and 326 IAC 8-5-3]

The following streamlined standards for the BPM process operations satisfy the Maximum Achievable Control Technology Standards fo r Pharmaceutical Production Operations (Pharmaceutical MACT) for process vents [40 CFR 63.1254], Prevention of Significant Deterioration Best Available Control Technology (PSD BACT) requirements [326 IAC 2-2-3] and Reasonably Available Control Technology (RACT) requirements for synthesized pharmaceutical manufacturing operations [326 IAC 8-5-3]:

(a) With the exception of Except as otherwise provided in Conditions D.6.1(c) and D.6.2,

the emission limits and standards applicable for Permittee shall route the vapors from each operating BPM process vent containing undiluted and uncontrolled process vent streams equal to or greater than 50 ppmv HAP 50 ppmv VOC or 15 pounds per day VOC through a closed

- vent system to the RTO control system, The operation, inspection and maintenance requirements for the RTO control system, and its closed

- vent system, used

to control emissions from these emission units are described in Section D.14 of this permit.

(13) The following conditions have been added to SECTION D.14 and SECTION D.15 to referenced the emission units controlled by the RTO and T79 fume incinerator control systems.

D.14.0 Requirement to Control Emissions [40 CFR 60 Subpart Kb, 40 CFR 63 Subpart GGG, 40 CFR 63 Subpart DD, 326 IAC 2-2-3, and 326 IAC 8-5-3]

Except for equipment excluded from emi ssion control requirements and except as otherwise provided by statute or rule, or in this permit, the fumes from all emission units which reference this section shall be continuously routed to the RTO control system while emission units vented to the control equipment are in operation. Except as otherwise provided by statute or rule, or in this permit

, the RTO control system shall be operated at all times that the emission units vented to the control equipment are in operation.Eli Lilly and Company – Tippecanoe Laboratories Page 37 of 60 Lafayette, Indiana SPM No.:157-22717-00006

Permit Reviewer: Aida De Guzman

D.15.0 Requirement to Control Emissions [40 CFR 60 Subpart Kb, 40 CFR 63 Subpart GGG, 40 CFR 63 Subpart DD, 326 IAC 2-2-3, and 326 IAC 8-5-3]

Except for equipment excluded from emi ssion control requirements and except as otherwise provided by statute or rule, or in this permit, the fumes from all emission units which reference this section shall be continuously routed to the T79 control system while emission units vented to the control equipment are in operation. Except as otherwise provided by statute or rule, or in this permit, the T79 control system shall be operated at all

times that the emission units vented to the control equipment are in operation.

(14) The Permittee has requested the following change to Condition D.7.1, to avoid reporting multiple deviations from conditions that are interrelated. With this change, emission control requirements that control the entir e plant bulk production manufacturing operations
are consolidated in SECTION D.14 and SECTION D.15.

D.7.1 Standards for BPM Support Process Vents [40 CFR 63.1254, CFR 63.690, 326 IAC 2-2-3, and 326 IAC 8-5-3]

The following streamlined standards for the BPM solvent recovery operations satisfy the Pharmaceutical MACT Standards for process vents [40 CFR 63.1254], OSWRO MACT Standards for process vents [40 CFR 63.690], PSD BACT requirements [326 IAC 2-2-3] and RACT requirements for synthesized pharmaceutical manufacturing operations [326 IAC 8-5-3]:

(a) With the exception of Except as otherwise provided in Condition D.7.1(c), the

emission limits and standards for the Permitee shall route the vapors from each operating BPM process vent containing undiluted and uncontrolled process vent streams equal to or greater than 50 ppmv VOHAP and/or 50 ppmv VOC through a closed

- vent system to either the RTO control system or T79 fume incinerator control system

, The operation, inspection and maintenance requirements for th e RTO control system and T79 fume incinerator control system, and associated closed

- vent systems, used to control

emissions from these emission units are described in SECTION D.14 for emission units controlled by the RTO control system and described in SECTION D.15 for emission units controlled by the T79 fume incinerator control system and D.15 of this permit, respectively.

(15) A sump was added in SECTION D.8 table that is regulated by the National Emission Standards of Hazardous Air Pollutants for Pharmaceutical Production Operations under 40 CFR 63, Subpart GGG or NESHAP from Off-site Waste and Recovery Operations under 40 CFR 63, Subpart DD.

SECTION D.8 ENTIRE PLANT BULK PHARMACE UTICAL MANUFACTURING (BPM) PRODUCTION

SUPPORT OPERATIONS – INDIVI DUAL DRAIN SYSTEM CONDITIONS

Facility Description [326 IAC 2-7-5(15)]

The information describing the processes contained in the following facility description boxes is descriptive

information and does not constitute enforceable conditions:

The emission units listed below are subject to applicabl e requirements described or referred to in this D section. These sumps are defined as individual dr ain systems under the National Emission Standards of

Hazardous Air Pollutants for Pharmaceutical Produc tion Operations (Pharmaceutical MACT) found at 40 CFR 63, Subpart GGG.Eli Lilly and Company – Tippecanoe Laboratories Page 38 of 60 Lafayette, Indiana SPM No.:157-22717-00006

Permit Reviewer: Aida De Guzman

Unit ID Unit Description Stack/Vent Nominal Capacity Control

Device

Building T27:

T27-Sump* Sump Tank/Lift Station RTO 2000 gal RTO

Building T28:

T28-Sump* Sump RTO 1300 gal RTO

Building T31:

T31-Sump* Sump RTO 5900 gal RTO

Building T31A:

T31A-Sump* Sump RTO 300 gal RTO
Building T19: T19-1-Sump* Sump None None
Building T149: T149-TK782* IDS None 100 gal None

* Emission units marked with an asterisk are insi gnificant activities as defined by 326 IAC 2-7- 1(21)(A)-(C).

(16) The Permittee has requested the following change to Condition D.8.1, to avoid reporting multiple deviations from conditions that are interrelated. With this change, emission control requirements that control the entir e plant bulk production manufacturing operations
are consolidated in SECTION D.14 and SECTION D.15.

D.8.1 BPM Individual Drain System (IDS) Standards [40 CFR 63.1256(e), 40 CFR 63.689(b), and 326 IAC 2-2-3]

The following streamlined standards for BPM IDSs sa tisfy the requirements of the Pharmaceutical MACT Standards for individual drain systems [40 CFR 63.1256(e)], OSWRO MACT Standards for transfer systems [40 CFR 63.689(b)], and PSD BACT requirements [326 IAC 2-2-3]:

(b) Operational Standards:

(1) The Permittee shall cover the openings of each operating BPM IDS containing waste equal to or greater than 500 parts per million by weight (ppmw) HAP and/or 500 ppmw VOC at all times during use except when it is necessary to use the opening for sampling or removal of material, or for equipment inspection, maintenance, or repair; and

(2) Except as otherwise provided in this Condition, the emission limits and

standards for The Permittee shall route the vapors from each operating BPM IDS containing waste equal to or greater than 500 ppmw HAP and/or 500 ppmw

VOC are described in SECTION D.14 for emission units controlled by the RTO control system and described in SECTION D.15 for emission units controlled by the T79 fume incinerator control system. th rough a closed

- vent system to either the RTO control system or T79 fume incinerator control system

, . The operation, inspection and maintenance requirements for the RTO control system and T79 fume incinerator control system, and associated closed

- vent syst ems, used to control emissions from these emission units are described in Sections D.14 and D.15 of this permit, respectively ; orEli Lilly and Company – Tippecanoe Laboratories Page 39 of 60 Lafayette, Indiana SPM No.:157-22717-00006

Permit Reviewer: Aida De Guzman

(17) T143-16 tank has been deleted from Secti on D.9 equipment list, as shown below and has been added to SECTION D.10 equipment as a waste tank.

SECTION D.9 ENTIRE PLANT BULK PHARMACE UTICAL MANUFACTURING (BPM) PRODUCTION

SUPPORT OPERATIONS – SOLVENT STORAGE TANK CONDITIONS

Emission

Unit ID Emission Unit Description Stack/Vent Nominal Capacity Control

Device

Building T143 – Tank Module:

T143-TK01 Solvent Tank T79 Incinerator 38,245 gal T79 Incinerator

T143-TK03 Solvent Tank T79 Incinerator 38,245 gal T79 Incinerator

T143-TK05 Solvent Tank T79 Incinerator 38,245 gal T79 Incinerator

T143-TK07 Solvent Tank T79 Incinerator 38,245 gal T79 Incinerator

T143-TK09 Solvent Tank T79 Incinerator 38,245 gal T79 Incinerator

T143-TK11 Solvent Tank T79 Incinerator 38,245 gal T79 Incinerator

T143-TK12 Solvent Tank T79 Incinerator 19,500 gal T79 Incinerator

T143-TK13 Solvent Tank T79 Incinerator 19,500 gal T79 Incinerator

T143-TK14 Solvent Tank T79 Incinerator 19,500 gal T79 Incinerator

T143

- TK16 Solvent Tank T79 Incinerator 19,500 gal T79 Incinerator

T143-TK17 Solvent Tank T79 Incinerator 19,500 gal T79 Incinerator

T143-TK18 Solvent Tank T79 Incinerator 19,500 gal T79 Incinerator

T143-TK19 Solvent Tank T79 Incinerator 19,500 gal T79 Incinerator

T143-TK20 Solvent Tank T79 Incinerator 19,500 gal T79 Incinerator

T143-TK21 Solvent Tank T79 Incinerator 19,500 gal T79 Incinerator

T143-TK22 Solvent Tank T79 Incinerator 19,500 gal T79 Incinerator

T143-TK23 Solvent Tank T79 Incinerator 19,500 gal T79 Incinerator

T143-TK24 Solvent Tank T79 Incinerator 19,500 gal T79 Incinerator

(18) An administrative amendment application has been submitted to IDEM, OAQ on February 27, 2006. However, an amendment has never been issued. The following requests will be included in this proposed significant permit modification:

(a) In SECTION D.10 table, remove T143-08 because this tank has been permanently

removed from service.

(b) Add T102-TK102 so that requirements will be incorporated in the Part 70 permit, and can be deleted from the RCRA permit.

SECTION D.10 ENTIRE PLANT BULK PHARMACE UTICAL MANUFACTURING (BPM) PRODUCTION

SUPPORT OPERATIONS – WASTE TANK CONDITIONS

Facility Description [326 IAC 2-7-5(15)]

The information describing the processes contained in the following facility description boxes is descriptive

information and does not constitute enforceable conditions:Eli Lilly and Company – Tippecanoe Laboratories Page 40 of 60 Lafayette, Indiana SPM No.:157-22717-00006

Permit Reviewer: Aida De Guzman
Emission

Unit ID Emission Unit Description Stack/Vent Nominal Capacity Control

Device

Building T27:

T27-TK53-10* Waste Tank RTO 500 gal RTO

Building T28:

T28-TK-28HW* Waste Tank RTO 250 gal RTO
Building T29: T29-TK7902* Waste Tank RTO 1000 gal RTO
Building T31: T31-TK609* Waste Tank RTO 100 gal RTO T31-TK669* Waste Tank RTO 100 gal RTO
Building T31A: T31A-TK451K* Waste Tank RTO 100 gal RTO T31A-TK688* Waste Tank RTO 125 gal RTO
Building T99: T99-TK-1B* Waste Tank RTO 100 gal RTO T99-TK-7B* Waste Tank RTO 210 gal RTO T99-TK-8B* Waste Tank RTO 210 gal RTO T99-TK-D45A* Waste Tank RTO 100 gal RTO
Building T100: T100-TK-10A* Waste Tank RTO 200 gal RTO T100-TK-48* Waste Tank RTO 3300 gal RTO

Building T79:

T79-TK301* Equalization Tank T79 - 321 stream 50,000 gal T79 Incinerator

T79-TK302* Equalization Tank T79 - 321 stream 50,000 gal T79 Incinerator

T79-TK303* Neutralization Tank T79 - 321 stream 5,000 gal T79 Incinerator

Building T102-RTOs

T102-TK102* 90 day RCRA Tank RTO 200 gal RTO

Tank Module Building T140:

T140-TK3122 Waste Tank T79 Incinerator 38,425 gal T79 Incinerator

T140-TK3123 Waste Tank T79 Incinerator 38,425 gal T79 Incinerator

T140-TK3124 Waste Tank T79 Incinerator 38,425 gal T79 Incinerator

T140-TK3125 Waste Tank T79 Incinerator 38,425 gal T79 Incinerator

T140-TK3126 Waste Tank T79 Incinerator 38,425 gal T79 Incinerator

T140-TK3227* Waste Tank T79 -324 stream 18,130 gal T79 Incinerator

T140-TK3228* Waste Tank T79 - 324 stream 18,130 gal T79 Incinerator

T140-TK3229* Waste Tank T79 - 324 stream 500 gal T79 Incinerator

Tank Module Building T142:

T142-TK01 Waste Tank T79 or RTO 19,500 gal T79 or RTO

T142-TK02 Waste Tank T79 or RTO 19,500 gal T79 or RTO

T142-TK03 Waste Tank T79 or RTO 19,500 gal T79 or RTO

T142-TK04 Waste Tank T79 or RTO 19,500 gal T79 or RTO

T142-TK05 Waste Tank T79 or RTO 19,500 gal T79 or RTOEli Lilly and Company – Tippecanoe Laboratories Page 41 of 60 Lafayette, Indiana SPM No.:157-22717-00006

Permit Reviewer: Aida De Guzman
Emission

Unit ID Emission Unit Description Stack/Vent Nominal Capacity Control

Device

T142-TK06 Waste Tank T79 or RTO 19,500 gal T79 or RTO

T142-TK07 Waste Tank T79 or RTO 19,500 gal T79 or RTO

T142-TK08 Waste Tank T79 or RTO 19,500 gal T79 or RTO

T142-TK09 Waste Tank T79 or RTO 19,500 gal T79 or RTO

T142-TK10 Waste Tank T79 or RTO 19,500 gal T79 or RTO

T142-TK11 Waste Tank T79 or RTO 19,500 gal T79 or RTO

T142-TK12 Waste Tank T79 or RTO 19,500 gal T79 or RTO

Tank Module Building T143:

T143-TK02* Waste Tank T79 - 325 stream 19,500 gal T79 Incinerator

T143-TK06* Waste Tank T79 - 325 stream 19,500 gal T79 Incinerator

T143

- TK08 Waste Tank T79 Incinerator 19,500 gal T79 Incinerator

T143-TK10* Waste Tank T79 - 325 stream 19,500 gal T79 Incinerator

T143-TK15* Waste Tank T79 - 325 stream 19,500 gal T79 Incinerator

T143-TK16 Waste Tank T79 Incinerator 19,500 gal T79 Incinerator T143-TK56* Knock Out Pot T79 Incinerator 45 gal T79 Incinerator

Tank Module Building T145:

T145-TK76* Knock Out Pot T79 Incinerator 45 gal T79 Incinerator T145-TK77* Knock Out Pot T79 Incinerator 45 gal T79 Incinerator

Tank Module Building T146:

T146-TK23 Waste Tank RTO 19,000 gal RTO

T146-TK24 Waste Tank RTO 19,000 gal RTO

T146-TK11* Waste Tank RTO 18,644 gal RTO

T146-TK20* Waste Tank RTO 18,644 gal RTO

T146-TK21* Waste Tank RTO 18,644 gal RTO

T146-TK12 Waste Tank RTO 19,500 gal RTO

T146-TK56* Knock Out Pot RTO 45 gal RTO

T48 Tank Farm:

T48-TK3207* Waste Tank T79 - 324 stream 102,759 gal T79 Incinerator

T48-TK3208* Waste Tank T79 - 324 stream 102,759 gal T79 Incinerator

T48-TK3209* Waste Tank T79 - 324 stream 102,759 gal T79 Incinerator

T48-TK3211* Waste Tank T79 - 324 stream 260,650 gal T79 Incinerator

T48-TK3212* Waste Tank T79 - 324 stream 260,650 gal T79 Incinerator

* Emission units marked with a single asterisk are in significant activities as defined in 326 IAC 2-7-1(21).

(19) The Permittee has requested the following change to Condition D.9.1, to avoid reporting multiple deviations from conditions that are in terrelated. With this change, emission control requirements that control the entire plant bulk production manufacturing operations are
consolidated in SECTION D.14 and SECTION D.15.Eli Lilly and Company – Tippecanoe Laboratories Page 42 of 60 Lafayette, Indiana SPM No.:157-22717-00006

Permit Reviewer: Aida De Guzman

D.9.1 Standards for BPM Solvent Storage Tanks [40 CFR 63.1253(c)(1)(i), 40 CFR 60.112b and 60.113b, 326 IAC 8-5-3, and 326 IAC 2-2]

The following streamlined standards for the BPM solvent storage tanks satisfy the requirements of the Pharmaceutical MACT Standards for storage tanks [40 CFR 63.1253(c)(1)(i)], Volatile Organic Liquid Storage Vessel Standards [40 CFR 60.112b and 60.113b], PSD BACT requirements [326 IAC 2-2-3] and RACT requirements for synthesiz ed pharmaceutical manufacturing operations [326 IAC 8-5-3]:

(b) Operational Standards:

(1) Except as otherwise provided in this Condition and in Condition D.9.2, T the Permittee shall route the vapors from each operating BPM solvent storage tank through a closed-vent system to either the RTO control system or the T79 fume incinerator control system, which are described in Section D.14 for equipment controlled by the RTO control system and described in Section D.15 for equipment controlled by the T79 fume incinerator control system. The operation, inspection and maintenance requirements for the RTO control system

and T79 fume in cinerator control system, and associated closed

- vent systems,
used to control emissions from these emission units are described in Sections D.14 and D.15 of this permit, respectively

.

(20) Condition D.9.3 has been changed to the following, since Section E.2 does not apply to
the tanks in Section D.9:

D.9.3 Leak Detection and Repair (LDAR) Standards [40 CFR 63.1255 and 326 IAC 2-2 ]

The LDAR standards that apply to components asso ciated with the emission units listed in this
section are described in Sections E.1 and E.2 of this permit.

(21) The Permittee has requested the following change to Condition D.10.1, to avoid reporting multiple deviations from conditions that are interrelated. With this change, emission control requirements that control the entir e plant bulk production manufacturing operations
are consolidated in SECTION D.14 and SECTION D.15.

D.10.1 Standards for BPM Waste Storage Tanks [40 CFR 63.1256(b), 40 CFR 63.685, 40 CFR 60.110b, 326 IAC 2-2-3, and 326 IAC 8-5-3]

The following streamlined standards for BPM waste storage tanks satisfy the requirements of the Pharmaceutical MACT Standards for wastewater tanks [40 CFR 63.1256(b)], Volatile Organic Liquid Storage Vessel Standards [40 CFR 60.110b], OSWRO MACT Standards for waste tanks [40 CFR 63.685], PSD BACT requirements [326 IAC 2-2-3], and RACT requirements for synthesized pharmaceutical manufacturing operations [326 IAC 8-5-3]:

(b) Operational Standards:

(1) Except as otherwise provided in this Condition and in Condition D.10.2, T the Permittee shall route the vapors from each operating BPM waste storage tank through a closed-vent system to either the RTO control system or the T79 fume incinerator control system, which are described in Section D.14 for equipment controlled by the RTO control system and described in Section D.15 for equipment controlled by the T79 fume incinerator control system. The operation, inspection and maintenance requirements for the RTO control system and T79 fume incinerator control system, and associated closed

- vent sys tems,
used to control emissions from these emission units are described in Sections D.14 and D.15 of this permit, respectively.Eli Lilly and Company – Tippecanoe Laboratories Page 43 of 60 Lafayette, Indiana SPM No.:157-22717-00006

Permit Reviewer: Aida De Guzman (22) The LDAR Standards in Condition D.11.1( d) has been deleted, since the LDAR Standards do not apply to small BPM waste containers. However, LDAR Standards apply to the large BPM waste containers. Therefore, the Conditions D.11.1 and D.11.2 have been changed as follows:

D.11.1 Standards for Small BPM Waste Containers [40 CFR 63.1256(d), 40 CFR 63.688, 326 IAC 2-2-3]

The following streamlined standards for small BPM waste containers satisfy the requirements of
the Pharmaceutical MACT Standards for wast ewater containers [40 CFR 63.1256(d)], OSWRO MACT Standards for waste containers [40 CFR 63.688], and PSD BACT requirements [326 IAC 2-2-3]:

(a) Definition Standards:

(1) A small BPM waste container is defined as any portable unit containing VOC/VOHAP material at concentrations greater than 500 ppmw with a storage capacity of greater than 0.1 cubic meters (26.4 gallons) and less than or equal to 0.42 cubic meters (110.5 gallons).

(b) Operational Standards:

(1) The cover and all openings on each BPM waste container shall be maintained in the closed position, except when adding material, removing material, accessing

material for non-transfer-related routi ne activities, openings caused from a pressure relief device, or opening of a safety device.

(2) Each BPM waste container containing VOC/VOHAP shall meet existing Department of Transportation (DOT) spec ifications and testing requirements
under 49 CFR 178.

(c) Inspection Standards:

(1) Initial and semiannual visual inspections shall be conducted for improper work practices and control equipment failures.

(2) Inspections that are unsafe or difficult to inspect are not subject to the inspection requirements of D.11.1(c)(1).

(3) The Permittee shall attempt to repair any defect within 24 hours after detection of the defective container and complete the repair within 5 calendar days after detection. If repair of a defect cannot be completed within 5 calendar days, then

the waste shall be removed from the container and the container shall not be used to manage waste until the defect is repaired.

(d) The LDAR standards that apply to the components associated with the emission units
listed in this section are described in Section E.2.

D.11.2 Standards for Large BPM Waste Containers [40 CFR 63.1256(d), 40 CFR 63.688, 326 IAC 2-2-3, 326 IAC 2-7-24]

The following standards represent the streamlined requirements of the Pharmaceutical MACT Standards under 40 CFR 63.1256(d), OSWRO MACT Standards under 40 CFR 63.688, and Best Available Control Technology (BACT) requirements under 326 IAC 2-2-3:

(a) Definition Standards:

(1) A large BPM waste container is defined as any portable unit containing VOC/VOHAP material at concentrations greater than 500 ppmw with a storageEli Lilly and Company – Tippecanoe Laboratories Page 44 of 60 Lafayette, Indiana SPM No.:157-22717-00006

Permit Reviewer: Aida De Guzman capacity of greater than 0.42 cubic meters (110.5 gallons).

(b) Operational Standards:

(1) The cover and all openings on each large BPM waste container shall be maintained in the closed position, and without leaks, except when adding material, removing material, accessing material for non-transfer-related routine activities, opening from a pressure relief device, and opening of a safety device.

(2) A submerged fill pipe shall be used when pumping BPM liquid waste into a large BPM waste container. The submerged fill pipe outlet shall extend to no more than 6 inches or within two fill pipe diameters of the bottom of the container while the container is being filled.

(c) Inspection Standards:

(1) One-time Method 21 inspections shall be conducted on each new large BPM waste container within 150 days upon first onsite usage.

(2) Initial and semiannual visual inspections shall be conducted for:

(A) Improper work practices;

(B) Control equipment failures; and

(C) Visible, audible, or olfa ctory indications of leaks.

(3) Inspections that are unsafe or difficult to inspect are not subject to the inspection requirements of D.11.2(c)(1) and (2).

(4) The Permittee shall attempt to repair any defect within 24 hours after detection of the defective container and complete the repair within 5 calendar days after detection. If repair of a defect cannot be completed within 5 calendar days, then

the waste shall be removed from the container and the container shall not be used to manage waste until the defect is repaired.

(d) The LDAR standards that apply to the components associated with the emission

units listed in this section are described in Section E.2.

(23) Condition D.12.2(b) has been deleted, since the USEPA has approved the revised requirements of 326 IAC 4-2 into the SIP, which exempts waste combustors that are subject to 40 CFR Part 63, Subpart EEE:

D.12.2 Particulate Matter Emission Standards [40 CFR 63.1203 and 326 IAC 4-2 40 CFR 52, Subpart P]

Except for periods of startup, shutdown and ma lfunctions, the following emission standards shall apply at all times the T149 rotary kiln incinerator is operating:

(a) In order to satisfy the HWC MACT standards [40 CFR 63.1203(a)(7)] and the approved Indiana State Implementation Plan (SIP) applic able to incinerators [40 CFR 52, Subpart P] , the particulate matter (PM) emissions from the T49 liquid waste incinerator stack exhaust shall not exceed 34 milligrams per dry standard cubic meter (mg/dscm) (0.015 grains per dry standard cubic feet (gr/dscf)), corrected to 7 percent oxygen.

(b) In order to satisfy the approved SIP applicable to incinerators [40 CFR Part 52, Subpart P], the T49 liquid waste incinerator shall:

( 1) Consist of primary and secondary chambers or the equivalent. The design and operation of this incinerator in accordance with the requirements of this section ofEli Lilly and Company – Tippecanoe Laboratories Page 45 of 60 Lafayette, Indiana SPM No.:157-22717-00006

Permit Reviewer: Aida De Guzman the permit is equivalent to the desi gn and operation of a primary and secondary chamber,

( 2) Be equipped with a primary burner unless burning wood products,

(3) Comply with 326 IAC 5

- 1 and 326 IAC 2,

(4) Be maintained properly as specified by the manufacturer and approved by the commissioner. The issuance of this permit shall be considered approval by the commissioner,

(5) Be operated according to the manufacturer’s recommendations and only burn waste approved by the commissioner. The issuance of this permit shall be considered approval by the commissioner,

(6) Comply with other state and /or local rules or ordinances regarding installation and operation of incinerators,

(7) Be operated so that emissions of hazardous material including, but not limited to, viable pathogenic bacteria, dangerous chemic als or gases, or noxious odors are

preve nted,

(8) Not emit particulate matter in excess of three

- tenths (0.3) pounds of particulate matter per one thousand (1,000) pounds of dry exhaust gas at standard conditions corrected to fifty percent (50%) excess air, and

(9) Not create a nuisance or a f ire hazard.

If any of the above result, the burning shall be terminated immediately. The terms of Condition D.12.2 (b) will no longer apply upon USEPA approval of the revised requirements of 326 IAC 4

- 2 (26 Ind. Reg. 1071) into the SIP because the T49 liq uid waste incinerator is subject to 40 CFR 63, Subpart EEE.

(24) The following Condition D.12.5(g) has been added to incorporate Operating Parameter Limits (OPLs) for the T49 Incinerator, established during performance tests done on August 10 through 12, 2004:

D.12.5 Hazardous Air Pollutant (HAP) and Fluoride Emission Standards [40 CFR 63.1203 and 326 IAC 2-2-3]

(g) Operating Parameter Limits – In order to comply with the NESHAP for Hazardous Waste Combustors (HWC) emission limits d escribed in this condition, the operating parameters of the T49 Incinerator, as established during the performance tests done on August 10 through 12, 2004, shall not exceed limits described below as

maximum limits or fail to achieve limits described as minimum limits.

Operating Parameter Limit Units Averaging

Period Demonstrates Compliance

for:

Minimum Atomizing

Air Media Pressure 60 psig 1-HR RA D.12.5(f)

Maximum Primary Waste Feed Viscosity 460 centipoise NA D.12.5(f)

Maximum Secondary Waste Feed Viscosity 460 centipoise NA D.12.5(f)

Maximum Primary

Waste Feed Rate 7,117 lbs/hr 1-HR RA D.12.5(e) D.12.5(f) Maximum Secondary 18,326 lbs/hr 1-HR RA D.12.5(e)Eli Lilly and Company – Tippecanoe Laboratories Page 46 of 60 Lafayette, Indiana SPM No.:157-22717-00006

Permit Reviewer: Aida De Guzman

Operating Parameter Limit Units Averaging

Period Demonstrates Compliance

for:
Waste Feed Rate D.12.5(f)

Minimum Combustion Temperature 1,850 o F 1-HR RA D.12.5(e) D.12.5(f)

Maximum

Combustion Air Flow

Rate 15,022 acfm 1-HR RA D.12.5(a) D.12.5(b) D.12.5(c) D.12.5(d) D.12.5(e) D.12.5(f) Maximum Mercury

Feed Rate 0.0042 lbs/hr 12-hr RA D.12.5(a)

Maximum SemiVolatile Metals (SVM)

Feed Rate 0.21 lbs/hr 12-hr RA D.12.5(b)

Maximum LowVolatile Metals (LVM)

Feed Rate 0.30 lbs/hr 12-hr RA D.12.5(c)

Maximum Ash Feed

Rate 1,710 lbs/hr 12-hr RA D.12.2(a)

Maximum Total

Chlorine Feed Rate 3,690 lbs/hr 12-hr RA D.12.5(d)

Minimum

Condenser/Absorber

Flow Rate 600 gpm 1-HR RA D.12.5(a) D.12.5(b) D.12.5(c) D.12.5(d)

Minimum Differential

Pressure across

Condenser/Absorber 0.5 in.w.c 1-HR RA D.12.5(a) D.12.5(b) D.12.5(c) D.12.5(d)

Minimum Hydro-Sonic

Scrubber Flow Rate 290 gpm 1-HR RA D.12.2(a) D.12.5(a)

D.12.5(b) D.12.5(c) D.12.5(d)

Minimum Hydro-Sonic Equivalent Differential

Pressure 75 in.w.c 1-HR RA D.12.2(a) D.12.5(a) D.12.5(b) D.12.5(c) D.12.5(d)

Minimum

Condenser/Absorber pH 4.9 S.U. 1-HR RA D.12.5(d)

Maximum

Condenser/Absorber

% Solids 3.5 %TDS 12-hr RA D.12.2(a) D.12.5(a) D.12.5(b) D.12.5(c)Eli Lilly and Company – Tippecanoe Laboratories Page 47 of 60 Lafayette, Indiana SPM No.:157-22717-00006

Permit Reviewer: Aida De Guzman (25) Condition D.12.6(b) has been deleted, si nce the USEPA has approved the revised requirements of 326 IAC 9-1 into the SIP, which exempts sources with Carbon Monoxide emissions limit under the NESHAP rule. The T49 Liquid Waste Incinerator is subject to NESHAP, Subpart EEE:

D.12.6 Carbon Monoxide (CO) Emission Standards [326 IAC 2-2-3, 40 CFR Part 52, Subpart P, 326 IAC 9-1, and 40 CFR 63.1203]

(b) In order to satisfy the carbon monoxide emission limitations in the appro ved SIP [40 CFR Part 52, Subpart P], the Permittee shall control carbon monoxide emissions in a direct flame afterburner or other controls approved by the Commissioner. Compliance with the emission limits described in D.12.6 (a) constitutes an approved co ntrol methodology. The terms of Condition D.12.6 (b) will no longer apply upon USEPA approval of the revised requirements of 326 IAC 9

- 1

- 2 into the SIP because the T49 liquid waste incinerator is subject to 40 CFR 63, Subpart EEE

. (26) Condition D.12.15 has been changed to the following to reference Operating Parameter Limits for the T49 Incinerator given in D.12.5.

D.12.15 Parametric Continuous Monitoring Systems (CMS) Requirements [40 CFR 63.8(c), 40 CFR 63.1209, and 326 IAC 2-1.1-11]

(a) The Permittee shall operate the following CMSs to monitor the Operating Parameter Limits (OPLs) listed in D.12.5(g) in accordance with the quality assurance requirements specified in 40 CFR 63.1209(d) at all times the T49 incinerator is in operation. To satisfy the HWC MACT standards [40 CFR 63.1209(b), (d), (e), (f) and (h)] and the requirements for PSD sources [326 IAC 2-1.1-11], the following parameters listed in D.12.5(g) shall be monitored at all times the T49 incinerator is in operation. In addition, the operating parameters monitored by the following CMSs shall not exceed the established operating parameter limits at all times the incinerator is burning waste.

(1) Dioxin/Furan CMS Requirements

– Pursuant to the HWC MACT standards [40 CFR

63.12 09(k)], the Permittee shall install and operate CMS monitors for the following
parameters:

(A) Combustion Chamber Temperature

- Minimum rolling hourly average combustion chamber temperature established from the average temperature measured during the thr ee DRE test runs;

(B) Combustion Air Flow Rate

- Maximum hourly rolling average combustion air flow rate established from the average of the maximum hourly rolling average for each performance test run; and

(C) Primary Waste Feed Rate

– Maximum hourly r olling average primary waste feed rate as established from the average of the maximum hourly rolling averages for each performance test run.

(D) Secondary Waste Feed Rate

- Maximum hourly rolling average secondary waste feed rate as established from the a verage of the maximum hourly rolling averages for each performance test run.

(2) DRE Standard CMS Requirements

– Pursuant to the HWC MACT standards [40 CFR 63.1209(j)], the Permittee shall install and operate CMS monitors for those parameters identified i n Condition D.12.15 (a)(1).

(3) Metals CMS Requirements

– Pursuant to the HWC MACT standards [40 CFR 63.1209(l) and (n)], the Permittee shall install and operate CMS monitors for the following parameters:Eli Lilly and Company – Tippecanoe Laboratories Page 48 of 60 Lafayette, Indiana SPM No.:157-22717-00006

Permit Reviewer: Aida De Guzman

(A) Waste Feed Rate

- Maximum 12

- hour rolling ave rage feed rates for total Hg, semi

- volatile metals (cadmium and lead) and low volatile metals (arsenic, beryllium, and chromium) in all waste feedstreams established from the average of the hourly rolling averages for each performance test run and approved extrapolation techniques;

(B) Scrubber Liquids Solid Content

- Maximum 12

- hour rolling average solids content of the scrubber liquid usi ng a continuous monitoring system established from the average of the performance test run averages. This parameter d oes not apply to mercury;

(C) Hydro

- Sonic TM Scrubber equivalent Pressure Drop

- Minimum hourly rolling average pressure drop across the Hydro

- Sonic TM scrubber established from the average of the performance test run averages;

(D) Scrubber Liquid Flow Rat e

- Minimum hourly rolling average scrubber liquid flow rate established from the average of the performance test run averages; and

(E) Flue Gas Flow Rate

- Maximum hourly rolling average flue gas flow rate, the maximum production rate, or another surroga te parameter for gas residence time, established from the average of the maximum hourly rolling averages for each test run.

(4) PM CMS Requirements

– Pursuant to the HWC MACT standards [40 CFR 63.1209(m)], the Permittee shall install and operate CMS moni tors for the following parameters:

(A) Those parameters identified in Condi tion D.12.15 (a)(3)(B), (C), and (D);

and

(B) Ash Feed Rate

- Maximum 12

- hour average ash feed rate established from the average of the test run averages.

(5) HCl/Cl 2 and Fluoride s CMS Requirements

– Pursuant to the HWC MACT standards [40 CFR 63.1209(o)] and compliance monitoring requirements for PSD sources [326 IAC 2

- 1.1

- 11], the Permittee shall install and operate CMS monitors for the following parameters:

(A) Those parameters iden tified in Condition D.12.15 (a)(3)(C), (D) and (E).

(B) Waste Feed Rate

- Maximum 12

- hour rolling average feed rates for chlorine (organic and inorganic) in all waste feedstreams established from the average of the performance test run averages. [40 CFR 63.1209(o)(1)]

(C) Scrubber Liquid pH

- Minimum hourly rolling average scrubber liquid pH established from the average of the performance test run averages. [40 CFR 63.1209(o)(3)(iv)]

(27) Condition D.13.2(b) has been deleted, since the USEPA has approved the revised requirements of 326 IAC 4-2 into the SIP, which exempts waste combustors that are subject to 40 CFR Part 63, Subpart EEE:

D.13.2 Particulate Matter Emission Standards [40 CFR 63.1203 and 40 CFR 52, Subpart P ]

Except for periods of startup, shutdown and ma lfunctions, the following emission standards shall apply at all times the T149 rotary kiln incinerator is operating:Eli Lilly and Company – Tippecanoe Laboratories Page 49 of 60 Lafayette, Indiana SPM No.:157-22717-00006

Permit Reviewer: Aida De Guzman

(a) In order to satisfy the HWC MACT standards [40 CFR 63.1203(b)(7)] and the approved Indiana State Implementation Plan (SIP) applicable to incinerators [40 CFR 52, Subpart P] , the particulate matter (PM) emissions from the T149 rotary kiln incinerator stack exhaust shall not exceed 34 mg/dscm (0.015 gr/dscf), corrected to 7 percent oxygen on a 6-hour rolling average basis, updated every hour.

(b) In order to satisfy the approved SIP applicable to incinerators [40 CFR Part 52, Subpart P], the T149 rotary kiln incinerator shall:

(1) Consist of primary and secondary chambers or the equivalent. The design and operation of t his incinerator in accordance with the requirements of this section of the permit is equivalent to the desi gn and operation of a primary and secondary

chamber.

(2) Be equipped with a primary burner unless burning wood products,

(3) Comply with 326 IAC 5

- 1 and 326 IAC 2,

(4) Be maintained properly as specified by the manufacturer and approved by the commissioner. The issuance of this permi t shall be considered approval by the

commissioner.

(5) Be operated according to the manufacturer’s recommendations and only burn waste approved by the commissioner. The issuance of this permit shall be considered approval by the commissioner.

(6) Comply with other state and/or local rules or ordinances regarding installation and operation of incinerators,

(7) Be op erated so that emissions of hazardous material including, but not limited to, viable pathogenic bacteria, dangerous chemic als or gases, or noxious odors are prevented,

(8) Not emit particulate matter in excess of three

- tenths (0.3) pounds of particulate

m atter per one thousand (1,000) pounds of dry exhaust gas at standard conditions corrected to fifty percent (50%) excess air, and

(9) Not create a nuisance or a fire hazard.

If any of the above result, the burning shall be terminated immediately.

The ter ms of Condition D.13.2 (b)(2) will no longer apply upon USEPA approval of the revised requirements of 326 IAC 4

- 2 (26 Ind. Reg. 1071) into the SIP because the T149 rotary kiln incinerator is subject to 40 CFR 63, Subpart EEE.

(28) Condition D.13.5 has been changed to the following to incorporate the Alternative Monitoring Petition (AMP) that was approved by the US EPA on January 27, 2006, and to incorporate Operating Parameter Limits (OPLs) for the T149 Rotary Kiln Incinerator, established during performance tests done on September 20 and 21, 2005:

D.13.5 Hazardous Air Pollutant (HAP) Emission Standards [40 CFR 63.1203, US EPA approved Alternative Monitoring Petition initially approved January 27, 2006]

Except for periods of startup, shutdown and ma lfunctions, the following emission standards shall apply at all times the T149 rotary kiln incinerator is operating:Eli Lilly and Company – Tippecanoe Laboratories Page 50 of 60 Lafayette, Indiana SPM No.:157-22717-00006

Permit Reviewer: Aida De Guzman (a) Mercury – Pursuant to the HWC MACT standards [40 CFR 63.1203(b)(2)], the mercury emissions from the T149 rotary kiln incinerator stack exhaust shall not exceed 45 ug/dscm, corrected to 7% oxygen on a 12-hour rolling average basis, from block hourly averages.

(b) Lead and Cadmium – Pursuant to the HWC MACT standards [40 CFR 63.1203(b)(3)], the total semi-volatile metals (lead and cadmium) emissions from the T149 rotary kiln incinerator stack exhaust shall not exceed 120 ug/dscm, corrected to 7 percent oxygen on a 12-hour rolling average basis, from block hourly averages.

(c) Arsenic, Beryllium, and Chromium – Pursuant to the HWC MACT standards [40 CFR 63.1203(b)(4)], the total low volatile metals (arsenic, beryllium, and chromium) emissions from the T149 rotary kiln incinerator stack exhaust shall not exceed 97 ug/dscm, corrected to 7 percent oxygen on a 12-hour rolling average basis, from block hourly averages.

(d) Hydrochloric Acid/Chlorine Gas (HCl/Cl 2 ) and Fluorides - In order to satisfy the HWC MACT standards [40 CFR 63.1203(b)(6)], the HCl/Cl 2 emissions from the T149 rotary kiln incinerator stack exhaust shall not exceed 21 ppmvdc, expressed as HCl equivalent on a 12-hour rolling average basis, from block hourly averages . In order to satisfy the PSD BACT requirements for fluorides [326 IAC 2-2-3], the T149 liquid waste incinerator control system shall achieve a HCl control efficiency of 98 percent or greater.

(e) Dioxin/Furans – Pursuant to HWC MACT standards [40 CFR 63.1203(b)(1)], the dioxin/furan emissions from the T149 rotary kiln incinerator stack exhaust shall not exceed 0.20 ng TEQ/dscm, corrected to 7 percent oxygen.

(f) Principle Organic Hazardous Constituents (POHCs) – Pursuant to the HWC MACT standards [40 CFR 63.1203(c)(1) and (2)], the Permittee shall comply with the following requirements:

(1) The destruction and removal effici ency (DRE) for each principle organic hazardous constituent (POHC), excluding dioxin-listed hazardous wastes F020, F021, F022, F023, F026, or F027 shall be at least 99.99 percent.

(2) Dioxin-listed hazardous wastes F020, F021, F022, F023, F026, or F027 shall not
be burned in the T149 rotary kiln incinerator



### .

(g) Operating Parameter Limits – In order to comply with the NESHAP from Hazardous Waste Combustors (HWC) emission limit s in this condition, the operating parameters of the T149 Rotary Kiln Incinerator, as established during the performance tests done on September 20 and 21, 2005, and associated emission control equipment shall not exceed limits described below as maximum limits or

fail to achieve limits described as minimum limits.

The limits below are applicable when monitoring is required by D.13.15(a).

Operating Parameter Limit Averaging

Period Operating

Limit Units

Maximum Primary Waste Feed to Primary

Combustion Chamber 1-hr RA 1 1,501 lbs/hr

Maximum Secondary Waste Feed to Primary

Combustion Chamber 1-hr RA 1 4,655 lbs/hr

Maximum Solid Feed Rate 1-hr RA 1 5,529 lbs/hr
Minimum Primary Combustion Chamber Temperature 1-hr RA 1 1,598 o F

Maximum Primary Waste Feed to Secondary

Combustion Chamber 1-hr RA 1 1,801 lbs/hr

Maximum Secondary Waste Feed to Secondary 1-hr RA 1 1,440 lbs/hrEli Lilly and Company – Tippecanoe Laboratories Page 51 of 60 Lafayette, Indiana SPM No.:157-22717-00006

Permit Reviewer: Aida De Guzman

Operating Parameter Limit Averaging

Period Operating

Limit Units

Combustion Chamber

Minimum Secondary Combustion Chamber Temperature 1-hr RA 1 1,809 o F

Maximum Stack Gas Flow Rate 1-hr RA 1 18,812 dscfm

Maximum Waste Feed Viscosity Monthly Analysis 460 Centi-poise

Minimum Waste Atomizing Pressure 1-hr RA 1 75 psig

Maximum Mercury Feed Rate in all Feed Streams 12-hr RA 0.0038 lbs/hr

Maximum SVM Feed Rate in all Feed Streams 12-hr RA 3.2 lbs/hr

Maximum LVM Feed Rate in all Feed Streams 12-hr RA 490 lbs/hr Maximum LVM feed rate in all Pumpable Feed

Streams 12-hr RA 5.0 lbs/hr

Maximum ash feed rate in all feed streams 12-hr RA 4,168 lbs/hr

Maximum Total Chlorine feed rate in all feed streams 12-hr RA 1,977 lbs/hr
Minimum Condenser/Absorber pressure drop 1-hr RA 1 in w.c.
Minimum Condenser/Absorber liquid feed pressure 1-hr RA 5 psig
Minimum Condenser/Absorber scrubber water pH 1-hr RA 2.5 pH Minimum Condenser/Absorber scrubber liquid flow

rate 1-hr RA 980 gpm

Minimum Hydro-Sonic Scrubber Equivalent Pressure Drop 1-hr RA 53 in w.c.

Maximum Hydro-Sonic Scrubber conductivity 12-hr RA 2.3 % solids
Minimum Hydro-Sonic Scrubber Liquid Feed Rate 1-hr RA 286 gpm
Minimum Hydro-Sonic Scrubber water pH 1-hr RA 2.5 pH

1. CMS shall be operated as described in D.13.15.

(29) Condition D.13.6(b) has been deleted, since the USEPA has approved the revised requirements of 326 IAC 9-1 into the SIP, which exempts sources with Carbon Monoxide emissions limit under the NESHAP rule. The T149 Rotary Kiln Incinerator is subject to NESHAP, Subpart EEE:

D.13.6 Carbon Monoxide (CO) Emission Standards [326 IAC 2-2-3, 40 CFR Part 52, Subpart P 326 IAC

9-1 , and 40 CFR 63.1203]

(b) In order to satisfy the CO emission limitat ions in the approved State Implementation Plan (SIP) [40 CFR Part 52, Subpart P], the Permittee shall control carbon monoxide

emissions in a d irect flame afterburner or other controls approved by the Commissioner. Compliance with the emission limits described in D.13.6 (a) constitutes an approved control methodology. The terms of Condition D.13.6 (b) will no longer apply upon USEPA approval of the revised requirements of 326 IAC 9

- 1

- 2 into the SIP because the T149 rotary kiln incinerator is subject to 40 CFR 63, Subpart EEE.

(30) Condition D.13.14 has been changed to the following, to incorporate the Alternative Monitoring Petition (AMP) that was approved by the US EPA on January 27, 2006:

D.13.14 Continuous Emissions Monitoring Systems (CEMS) Operating Requirements [40 CFR 60, Appendix B and Appendix F, 40 CFR 63.8, 326 IAC 2-1.1-11, 326 IAC 3-5, Alternative Monitoring Petition initially approved January 27, 2006]

(a) CO and O 2 CEMS Operation Requirements – The following requirements shall be applied at all times the T149 rotary kiln incinerator is in operation and represent the streamlinedEli Lilly and Company – Tippecanoe Laboratories Page 52 of 60 Lafayette, Indiana SPM No.:157-22717-00006

Permit Reviewer: Aida De Guzman requirements of the HWC MACT standards for CO and HC [40 CFR 63.1209(a), (d), (e), (f), and (h)], PSD BACT requirements for CO and VOC [326 IAC 2-1.1-11], and the emission monitoring requirements for MACT and PSD sources [326 IAC 3-5-1(b) and (d)]:

(1) The Permittee shall install and operate the CO and O 2 CEMS in accordance with the QA requirements of the HWC MACT standards [40 CFR 63, Appendix to Subpart EEE], the applicable QC and performance evaluation requirements of 40 CFR 63.1209(d), and the applicable performance specification requirements of 40 CFR 60, Appendix B , and the Alternative Monitoring Petition (“AMP”) initially approved on January 27, 2006 and all subsequent revisions to the AMP.

(2) The CEMS shall be installed and operational upon certification of the DOC for the

HWC MACT.

(3) Continuous operation is defined as the co llection of at least one measurement for each successive 15-second period, regardless of startup, shutdown and

malfunction.

(b) SO 2 and NOx CEMS Operation Requirements – The following requirements shall apply when the T149 rotary kiln incinerator is burning waste:

(1) The Permittee shall install and operate the SO 2 and NOx CEMS in accordance with the QA/QC criteria set forth in 40 CFR 60, Appendix B

, and 40 CFR 60, Appendix F, Procedure 1, and the AMP approved on January 27, 2006.

(2) Continuous operation is defined as the co llection of at least one measurement for each successive 15-minute period.

(3) The Startup, Shutdown, and Malfunc tion (SSM) Plan required by Condition D.13.12 (b) shall include procedures for monitoring and recording the following information during times of SO 2 or NOx CEMS malfunction:

(A) When the SO 2 CEMS malfunctions, the Permittee shall monitor and record the Hydro-SonicTM equivalent pressure drop and scrubber liquid flow rate as required by Condi tion D.13.15 (a)(3)(C) and (D) and the scrubber liquid pH as required by Condition D.13.15 (a)(5)(C).

(B) When the NOx CEMS malfunctions, the Permittee shall monitor and record the combustion chamber temperature, combustion air flow rate, and primary and secondary waste feed rates as required by Condition D.13.15 (a)(1), and assess NOx emissions, using waste testing, waste shipment and process knowledge, to determine whether the quantity of nitrogen fed into the incinerator during that time could have exceeded the worst case 24-hour daily average nitrogen feed rate of 1,379 pounds per
hour that formed the basis of the NOx BACT limit.

(c) Particulate Matter [PM] CEMS Alternative Operating Scenario Requirements – This permit provides the Permittee with the following Alternative Operating Scenario for purposes of satisfying the monitoring requirements of 40 CFR 63.1209. The Permittee shall operate the PM CEMS at all times the T149 Incinerator is in operation, except as provided in paragraphs (3) or (4) below.

(1) The Permittee shall install and operate the PM CEMS in accordance with the QA/QC criteria set forth the AMP approved on January 27, 2006, and all subsequent revisions to the AMP.

(2) Continuous operation is defined as the collection of at least one measurement for each successive 15-minute period. In order to calculate aEli Lilly and Company – Tippecanoe Laboratories Page 53 of 60 Lafayette, Indiana SPM No.:157-22717-00006

Permit Reviewer: Aida De Guzman valid one-hour block average, valid results must be available for at least three of the four 15-minute cycles in each hour.

(3) During periods when the PM CEMS is malfunctioning or inoperative, the Permittee may use data from the Multi-Metal CEMS, as provided in the AMP approved January 27, 2006 and all subsequent revisions to the AMP.

(4) In lieu of operating the PM CEMS, the Permittee may satisfy the monitoring requirements of 40 CFR 63.1209 through operation of the Continuous Monitoring System requirements described in Section D.13.15(a).

(d) Multi-Metals [MMX] CEMS Alternative Operating Scenario Requirements – This permit provides the Permittee with the following Alternative Operating Scenario for purposes of satisfying the monitoring requirements of 40 CFR 63.1209. The Permittee shall operate the MMX CEMS at all times the T149 Incinerator is in operation, except as provided in paragraphs (3) or (4) below.

(1) The Permittee shall install and operate the MMX CEMS in accordance with the QA/QC criteria set forth the AMP approved on January 27, 2006, and all subsequent revisions to the AMP.

(2) Continuous operation is defined as the collection of at least one measurement for each successive 15-minute period. In order to calculate a valid one-hour block average, valid results must be available for at least three of the four 15-minute cycles in each hour.

(3) During periods when the MMX CEMS is malfunctioning or inoperative, the Permittee may use data from the PM CEMS, as provided in the AMP approved on January 27, 2006 and all subsequent revisions to the AMP.

.

(4) In lieu of operating the MMX CEMS, the Permittee may satisfy the monitoring requirements of 40 CFR 63.1209 through operation of the Continuous Monitoring System requirements described in Section D.13.15(a).

(e) Hydrogen Chloride [HCl] CEMS Alternative Operating Scenario Requirements – This permit provides the Permittee with the following Alternative Operating Scenario for purposes of satisfying the monitoring requirements of 40 CFR 63.1209. The Permittee shall operate the HCl CEMS at all times the T149 Incinerator is in operation, except as provided in paragraphs (3) or (4) below.

(1) The Permittee shall install and operate the HCl CEMS in accordance with the QA/QC criteria set forth the AMP approved on January 27, 2006, and all subsequent revisions to the AMP.

(2) Continuous operation is defined as the collection of at least one measurement for each successive 15-minute period.

(3) In lieu of operating the HCl CEMS, the Permittee may satisfy the monitoring requirements of 40 CFR 63.1209 through operation of the Continuous Monitoring System requirements described in Section D.13.15(a).

(31) Condition D.13.15, Parametric Continuous Monitoring Systems (CMS) Requirements has been changed to the following:Eli Lilly and Company – Tippecanoe Laboratories Page 54 of 60 Lafayette, Indiana SPM No.:157-22717-00006

Permit Reviewer: Aida De Guzman

D.13.15 Parametric Continuous Monitoring Systems (CMS) Requirements [40 CFR 63.8(c), 40 CFR 63.1209, and 326 IAC 2-1.1-11]

(a) The Permittee shall operate the following CMSs in accordance with the quality assurance requirements specified in 40 CFR 63.1209(d) at all times the T149 incinerator is in operation. To satisfy the HWC MACT standards [40 CFR 63.1209(b), (d), (e), (f), and (h)] and the requirements for PSD sources [326 IAC 2-1.1-11], the following parameters shall be monitored at all times the T149 incinerator is in operation. I n addition, the operating parameters monitored by the following CMSs shall not exceed the established operating parameter limits at all times incinerators are burning waste:

. The permittee shall operate the CMS as provided in the table below

. The CEMS mode is when the HCl CEMS, and either the PM and/or the Metal CEMS are in operation in accordance with Condition D.13.14. If the permittee is not operating in CEMS mode, then the CMS in

the Parametric Mode must be monitored.

Operating Parameter Monitor

when in

CMS

Parametric

Mode Monitor

when in

CEMS

Mode Averaging

Period Units Parameter for:

Maximum Primary Waste Feed to Primary

Combustion Chamber X X 1-hr RA lbs/hr D.13.5(e) D.13.5(f)

Maximum Secondary Waste Feed to Primary

Combustion Chamber X X 1-hr RA lbs/hr D.13.5(e) D.13.5(f)

Maximum Solid Feed

Rate X X 1-hr RA lbs/hr D.13.5(e) D.13.5(f)

Minimum Primary

Combustion Chamber Temperature X X 1-hr RA o F D.13.5(e) D.13.5(f)

Maximum Primary Waste Feed to Secondary

Combustion Chamber X X 1-hr RA lbs/hr D.13.5(e) D.13.5(f)

Maximum Secondary

Waste Feed to Secondary Combustion

Chamber X X 1-hr RA lbs/hr D.13.5(e) D.13.5(f)

Minimum Secondary

Combustion Chamber Temperature X X 1-hr RA o F D.13.5(e) D.13.5(f)

Maximum Stack Gas

Flow Rate X X 1-hr RA dscfm D.13.5(a) D.13.5(b) D.13.5(c) D.13.5(d) D.13.5(e) D.13.5(f)

Maximum waste feed viscosity X X Monthly Analysis Centipoise D.13.5(f)Eli Lilly and Company – Tippecanoe Laboratories Page 55 of 60 Lafayette, Indiana SPM No.:157-22717-00006

Permit Reviewer: Aida De Guzman

Operating Parameter Monitor

when in

CMS

Parametric

Mode Monitor

when in

CEMS

Mode Averaging

Period Units Parameter for:

Minimum Waste Atomizing Pressure X X 1-hr RA psig D.13.5(f)

Maximum Particulate Matter (PM) limit X 6-hr RA mg/dscm D.13.2(a)

Maximum HCl/Cl 2 emissions X 12-hr RA ppmv D.13.5(d)

Maximum Mercury

Emissions X 12-hr RA ug/dscm D.13.5(a)

Maximum SVM

emissions X 12-hr RA ug/dscm D.13.5(b)

Maximum LVM

Emissions X 12-hr RA ug/dscm D.13.5(c)

Maximum mercury feed

rate in all feed streams X 12-hr RA lbs/hr D.13.5(a)

Maximum SVM feed rate

in all feed streams X 12-hr RA lbs/hr D.13.5(b)

Maximum LVM feed rate

in all feed streams X 12-hr RA lbs/hr D.13.5(c)

Maximum LVM feed rate in all pumpable feed

streams X 12-hr RA lbs/hr D.13.5(c)

Maximum ash feed rate

in all feed streams X 12-hr RA lbs/hr D.13.2(a)

Maximum Total Chlorine

feed rate in all feed

streams X 12-hr RA lbs/hr D.13.5(d)

Minimum

Condenser/Absorber pressure drop X 1-hr RA in w.c. D.13.5(a) D.13.5(b) D.13.5(c) D.13.5(d)

Minimum

Condenser/Absorber liquid feed pressure X 1-hr RA psig D.13.5(a) D.13.5(b) D.13.5(c) D.13.5(d)

Minimum

Condenser/Absorber scrubber water pH X 1-hr RA pH D.13.5(d)

Minimum

Condenser/Absorber scrubber liquid flow rate X 1-hr RA gpm D.13.5(a) D.13.5(b) D.13.5(c) D.13.5(d)Eli Lilly and Company – Tippecanoe Laboratories Page 56 of 60 Lafayette, Indiana SPM No.:157-22717-00006

Permit Reviewer: Aida De Guzman

Operating Parameter Monitor

when in

CMS

Parametric

Mode Monitor

when in

CEMS

Mode Averaging

Period Units Parameter for:

Minimum Hydro-Sonic Scrubber Equivalent Pressure Drop X 1-hr RA in w.c. D.13.2(a) D.13.5(a) D.13.5(b) D.13.5(c) D.13.5(d)

Maximum Hydro-Sonic Scrubber conductivity X 12-hr RA % solids D.13.2(a) D.13.5 (a) D.13.5(b) D.13.5(c)

Minimum Hydro-Sonic Scrubber Liquid Feed

Rate X 1-hr RA gpm D.13.2(a) D.13.5(a) D.13.5(b) D.13.5(c) D.13.5(d)

Minimum Hydro-Sonic Scrubber water pH X 1-hr RA pH D.13.5(d)

(1) Dioxin/Furan CMS Requirements

– Pursuant to the HWC MACT stan dards [40 CFR 63.1209(k)], the Permittee shall install and operat e CMS monitors for the following parameters:

(A) Combustion Chamber Temperature

- Minimum rolling hourly average combustion chamber temperature established from the average temperature measu red during the three DRE test runs;

(B) Flue Gas Flow Rate

- Maximum hourly rolling average flue gas flow rate established from the average of the maximum hourly rolling average for each performance test run; and

(C) Primary Waste Feed Rate

– Maximum ho urly rolling average primary waste feed rate as established from the average of the maximum hourly rolling averages for each performance test run.

(D) Secondary Waste Feed Rate

- Maximum hourly rolling average secondary waste feed rate as established from the average of the maximum hourly rolling averages for each performance test run.

(2) DRE Standard CMS Requirements

– Pursuant to the HWC MACT standards [40 CFR 63.1209(j)], the Permittee shall install and operate CMS monitors for those parameters identi fied in Condition D.13.16 (a)(1).

(3) Metals CMS Requirements

– This permit provides the Permittee with the following Alternative Operating Scenario for purposes of satisfying the monitoring requirements of 40 CFR 63.1209. Pursuant to the HWC MACT standar ds [40 CFR 63.1209(l) and (n)], if the Permittee is not operating the MMX or PM CEMS pursuant to Condition D.13.14(d), the Permittee shall install and operate CMS monitors for the following parameters: (A) Waste Feed Rate

- Maximum 12

- hour rolling average feed rates for total Hg, semi

- volatile metals (cadmium and lead) and low volatile metals (arsenic, beryllium, and chromium) in all waste feedstreams establishedEli Lilly and Company – Tippecanoe Laboratories Page 57 of 60 Lafayette, Indiana SPM No.:157-22717-00006

Permit Reviewer: Aida De Guzman from the average of the hourly rolling averages for each performance test run and approved extr apolation techniques;

(B) Scrubber Liquids Solid Content

- Maximum 12

- hour rolling average solids content of the scrubber liquid usi ng a continuous monitoring system established from the average of the performance test run averages. This parameter does n ot apply to mercury;

(C) Hydro

- Sonic TM Equivalent Pressure Drop

- Minimum hourly rolling average pressure drop across the Hydro

- Sonic TM scrubber established from the average of the performance test run averages;

(D) Scrubber Liquid Flow Rate

- Minimum ho urly rolling average scrubber liquid flow rate established from the average of the performance test run averages; and

(E) Flue Gas Flow Rate

- Maximum hourly rolling average flue gas flow rate, the maximum production rate, or another surrogate parameter f or gas residence time, established from the average of the maximum hourly rolling averages for each test run.

(4) PM CMS Requirements

– This permit provides the Permittee with the following Alternative Operating Scenario for purposes of satisfying the mo nitoring requirements of 40 CFR 63.1209. Pursuant to the HWC MACT standards [40 CFR 63.1209(m)], if the Permittee is not operating the PM or MMX CEMS pursuant to Condition D.13.14(c), the Permittee shall install and operate CMS monitors for the following p arameters:

(A) Those parameters identified in Condi tion D.13.15(a)(3)(B), (C), and (D);

and

(B) Ash Feed Rate

- Maximum 12

- hour average ash feed rate established from the average of the test run averages.

(5) HCl/Cl 2 and Fluorides CMS Requirements

– T his permit provides the Permittee with the following Alternative Operating Scenario for purposes of satisfying the monitoring requirements of 40 CFR 63.1209. Pursuant to the HWC MACT standards [40 CFR 63.1209(o)] and compliance monitoring requirements for PSD sources [326 IAC 2

- 1.1

- 11], if the Permittee is not operating the HCL CEMS pursuant to Condition D.13.14(e), the Permittee shall install and operate CMS monitors for the following parameters:

(A) Those parameters identified in Condition D.13.16 (a)(3) (C), (D) and (E).

(B) Waste Feed Rate

- Maximum 12

- hour rolling average feed rates for chlorine (organic and inorganic) in all waste feedstreams established from the average of the performance test run averages. [40 CFR 63.1209(o)(1)]

(C) Scrubber Liqui d pH

- Minimum hourly rolling average scrubber liquid pH established from the average of the performance test run averages. [40 CFR 63.1209(o)(3)(iv)]Eli Lilly and Company – Tippecanoe Laboratories Page 58 of 60 Lafayette, Indiana SPM No.:157-22717-00006

Permit Reviewer: Aida De Guzman

(32) The following condition has been added in Condition D.13.18(a) and was numbered (14).

D.13.18 Record keeping Requirements

(a) The Permittee shall maintain the following records:

(14) The time periods in which the Permittee is operating in CEMS mode as the primary monitoring scenario or the CMS systems described in D.13.15 as the primary monitoring scenario.

(33) The following condition has been added under Compliance Determination Section and numbered as D.14.4, since Condition C.5 Oper ation of Equipment has been deleted from the permit. Subsequent conditions have been re-numbered accordingly:

Compliance Determination Requirements

D.14.4 Requirement to Control Emissions [40 CFR 60 Subpart Kb, 40 CFR 63 Subpart GGG, 40 CFR 63 Subpart DD, 326 IAC 2-2-3, and 326 IAC 8-5-3]

Except for equipment excluded from emi ssion control requirements and except as otherwise provided by statute or rule, or in this permit, the RTO control system shall be operated at all times that the emission units vented to the control equipment are in operation.

(34) The following condition has been added under Compliance Determination Section and numbered as D.15.4, since Condition C.5 Oper ation of Equipment has been deleted from the permit. Subsequent conditions have been re-numbered accordingly:

Compliance Determination Requirements

D.15.4 Requirement to Control Emissions [40 CFR 60 Subpart Kb, 40 CFR 63 Subpart GGG, 40 CFR 63 Subpart DD, 326 IAC 2-2-3, and 326 IAC 8-5-3]

Except for equipment excluded from emi ssion control requirements and except as otherwise provided by statute or rule or in this permit, the T79 control system shall be operated at all times that the emission units vented to the control equipment are in operation.

(35) Starting September 13, 2007, Boilers 1, 2, and 3 will no longer be using coal for fuel, instead 100% of natural gas will be used. C ondition G.1.4(a) has been revised to require the Permittee to calculate the NOx emissions, each month, by multiplying the amount of natural gas burned in each calendar month by a NOx emission factor of 100 lbs NOx/million cubic feet of natural gas burned; and

The following condition for calculating NOx emissions from boilers No 6 and 7, was added and numbered G.1.4(i):

G.1.4 Nitrogen Oxides (NO X ) Emission Limit Determination [326 IAC 2-2.4-7(6) & (7)] [326 IAC 2-2.4-12]

The Permittee shall determine actual annual emi ssions of NOx by employing the following techniques:

(a) The Permittee shall calculate NOx emissions from Boilers 1, 2, and 3, in tons, each calendar month, by multiplying the amount of coal consumed in each calendar month by a NOx

emission factor of 16 lb NOx/ton of coal burned. After the coal feed to Boilers No. 1, No.Eli Lilly and Company – Tippecanoe Laboratories Page 59 of 60 Lafayette, Indiana SPM No.:157-22717-00006

Permit Reviewer: Aida De Guzman 2, and No. 3 is shutdown, or starting September 13, 2007, whichever comes first, the

NOx emissions from these boilers shall be calculated using an emission factor of 100 lbs NOx/million cubic feet of natural gas burned.

(b) The Permittee shall calculate NOx emissions from burning natural gas in Boilers 4 and 5, in tons, each calendar month, by multiplying the amount of natural gas burned in each calendar month by an NOx emission factor of 280 lb NOx/million cubic feet of natural gas burned in Boiler 4 and 100 lb NOx/million cubic feet of natural gas burned in Boiler 5.

(c) The Permittee shall calculate NOx emissions from burning fuel oil in Boilers 4 and 5, in tons, each calendar month, by multiplying the amount of fuel oil burned in each calendar month by an NOx emission factor of 24 lb NOx/1000 gallons of fuel oil burned in Boiler 4 and 20 lb NOx/1000 gallons of fuel oil burned in Boiler 5.

(d) The Permittee shall determine NOx emissions from diesel engines, in tons, each calendar month, through one of the methods described in (1) and (2) below. The Permittee shall identify which method it used when it repor ts emissions pursuant to Condition G.1.8.

(1) Potential to emit method : The Permittee shall use the following values, which represent the NOx potential to emit of the diesel engines, as the actual emissions:

(A) For the T121 1250 KW diesel electr ical generator – 1.5 ton/month [18.1 ton/yr].

(B) For the T5 380 HP diesel emergency generator – 0.2 ton/month [2.9 ton/yr]

(C) For the T62 1100 KW diesel emergency generator – 0.7 ton/month [8.9 ton/yr].

(D) For the T135 390 HP diesel emergency generator – 0.3 ton/month [3.0 ton/yr].

(E) For the T78 58 KW diesel compressor engine – 0.9 ton/month [10.6 ton/yr]

(F) For the T89-1 KW diesel compressor engine – 0.9 ton/month [10.6 ton/yr].

(G) For the T89-2 KW diesel compressor engine – 0.9 ton/month [10.6 ton/yr]. (H) (e) The Permittee shall calculate NOx emissions from the T174 Thermal Research Incinerator, in tons, each calendar month, by multiplying the actual hours of operation of the incinerator for each month by a NOx emission factor of 2.5 lb NOx/hour of operation.

(f) The methods for determining monthly NOx em issions from the T49 Incinerator, the T149 Incinerator, the RTOs, and the T79 Fume Incinerators are described in Condition F.1.5 of this permit.

(g) NOx emissions from the T71 Pilot Plant are equivalent to the potential to emit for this facility – 0.1 ton/yr.

(h) When determining actual annual emissions of NOx, the Permittee shall include emissions occurring as a result of startups, shutdown, and malfunctions.

(i) The Permittee shall determine NOx emissions from boilers No. 6 and No. 7, in tons, each calendar month, using CEMS data from Condition D.20.16 and using the following method to determine NOx emission limits in Condition D.20.4: NOxEli Lilly and Company – Tippecanoe Laboratories Page 60 of 60 Lafayette, Indiana SPM No.:157-22717-00006

Permit Reviewer: Aida De Guzman emissions in lbs = lbs NOx/MMBTU * fuel usage( scf for natural gas, and gallons for fuel oil) * Heat content per unit of fuel used. A value of 1000 BTU/scf of natural gas shall be used if heat content data for the natural gas is unavailable. If data is not available for calculating the NOx emissions, the following substitution value shall be used: 32.0 lbs NOx/Hour. This value represents the maximum potential

emissions of each boiler.

(36) Condition G.1.5(a) has been revised by addi ng the following condition for calculating SO 2 emissions from boilers No 1, No. 2, and No. 3 when burning 100 % natural gas, and Condition G.1.5 (j)was added for calculating SO 2 emissions from boilers No. 6 and No. 7:

G.1.5 Sulfur dioxides (SO 2 ) emission limit determination [326 IAC 2-2.4-7(6) & (7)] [326 IAC 2-2.4-12]

The Permittee shall determine actual annual emissions of SO 2 by employing the following techniques:

(a) The Permittee shall calculate SO 2 emissions from Boilers 1, 2, and 3, in tons, each calendar month, by multiplying the amount of coal consumed in each calendar month by
an SO 2 emission factor of 38*S lb SO 2 /ton of coal burned, where S = the percent sulfur content of the coal as determined by Condi tion D.1.7. In addition, the Permittee shall
calculate the SO 2 emissions from burning natural gas in Boilers 1, 2, and 3, in tons, each calendar month, by multiplying the amount of natural gas burned in each calendar month by an SO 2 emission factor of 0.6 lb SO 2 /million cubic feet of natural gas burned.

After the coal feed to Boilers No. 1, No. 2, and No. 3 is shutdown, or starting September 13, 2007, whichever comes first, the Permittee shall calculate, one hundred percent (100%) of the SO 2 emissions from Boilers 1, 2, and 3, each calendar month, by multiplying the amount of natural gas burned in each calendar month by a SO 2 emission factor of 0.6 lbs SO 2 /million cubic feet of natural gas

burned.

(i) The Permittee shall calculate SO 2 emissions from burning natural gas in boilers No. 6 and No. 7, in tons, each calendar month by multiplying the amount of natural gas burned in each calendar month by an SO 2 emission factor of 0.6 lb SO 2 /million cubic feet of natural gas burned.

(j) The Permittee shall calculate SO 2 emissions from burning fuel oil in boilers No. 6 and No. 7, in tons, each calendar month, by multiplying the amount of fuel oil burned in each calendar month by an SO 2 emission factor of 42.6 lb SO 2 /1000 gallons of fuel oil burned.

Conclusion and Recommendation

The construction of this proposed modification sha ll be subject to the conditions of the attached proposed Part 70 Significant Permit Modification No. 157-22717-00006 . The staff recommends to the Commissioner that this Part 70 Significant Source Modification be approved.