**Indiana Department of Environmental Management**

**Office of Air Quality**

Technical Support Document (TSD) for a combined

Prevention of Significant Deterioration (PSD) Flexible Permit and

Part 70 Operating Permit

**Source Background and Description**

# 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**

**Permit Reviewer:** **Dr. Trip Sinha**

> The Office of Air Quality (OAQ) has reviewed a Part 70 permit
> application and Prevention of Significant Deterioration (PSD) permit
> application from Eli Lilly and Company -- Tippecanoe Laboratories. The
> PSD permit application is for the construction, modification, and
> operation of bulk pharmaceutical manufacturing operations and
> associated support facilities. The Part 70 permit application
> addresses the bulk pharmaceutical manufacturing operations and
> associated support facilities, and fermentation and purification
> operations, research and development facilities, and associated site
> support facilities.
>
> Because Tippecanoe Laboratories is a large and complex source, this
> technical support document describes source-wide emissions information
> and regulatory requirements and references the reader to a series of
> appendices containing more detailed information on various aspects of
> the plant site.

**Permitted Emission Units and Pollution Control Equipment**

The source consists of the following operating areas that are made up of
various types of emission units and pollution control devices. These
operating areas correspond to the various "D" sections of the Part 70
permit and are described in more detail in Appendix A of this TSD.
Appendix A of this TSD also includes a detailed description of the Leak
Detection and Repair (LDAR) program that applies to the emission units
and control equipment. The LDAR program requirements correspond to the
"E" sections of the Part 70 permit.

(a) Utility operations -- The utilities operations consist of three
    coal-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.

(b) Utility support operations -- The utility support operations consist
    of a lime system for the potable water system (T9/T23), glycol tanks
    for heating and cooling of BPM tanks, and chillers, generators and
    compressors.

(c) Fermentation product 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).

(d) Fermentation product purification operations -- The whole broth from
    fermentation are continuously fed to the purification operations
    consisting of extraction and elution equipment located in buildings
    T3 and T40. Products are stored in Building T39. Solvents used in
    the purification processes are stored in tank module T147 and
    recovered in the T4 solvent recovery operation.

(e) Fermentation product support operations -- The support operations
    for the Fermented Products (FP) area consists of the FP wastewater
    treatment plant and FP wastewater sludge storage operations.

(f) Bulk pharmaceutical manufacturing (BPM) process operations -- The
    bulk pharmaceutical manufacturing component of Tippecanoe Labs
    includes Buildings T27, T28, T29, T31/31A, T99, and T100.
    Pharmaceutical products are manufactured by chemical synthesis in
    bulk scale in all of these buildings. Typical production equipment
    includes process vessels (tanks), centrifuges and dryers. Depending
    on the process, production facilities may also utilize process
    condensers and/or process scrubbers. The exhaust streams from the
    process equipment are vented to the RTO system for control of
    emissions.

(g) BPM storage tanks -- Solvents used as raw material in BPM, used
    solvents to be recovered in solvent recovery, and waste solvents
    generated in BPM are stored in several storage tank modules. The
    modules are identified as T140, T142, T143, T145 and T146. The
    exhaust streams from the storage tanks are vented to either the T79
    fume incinerators or RTOs for control of VOC and VOHAP emissions.

(h) Waste containers -- Waste containers from the BPM operations or
    waste containers from other Lilly facilities consist of any portable
    container with a capacity greater than or equal to 0.1 cubic meters
    (26.4 gallons) used to convey, store, treat, or dispose of affected
    waste streams or residuals. Waste containers are located in the BPM
    process operation buildings as well as the T149 container storage
    building.

(i) BPM individual drain system -- The individual drain systems are
    stationary systems, such as sumps, process drains and lift stations,
    used to convey affected wastewater streams or residuals to a waste
    management unit in the BPM operating areas. The exhaust streams from
    the BPM individual drain systems are vented to the RTO system for
    control of VOC and VOHAP emissions.

(j) BPM solvent recovery - Solvent Recovery occurs in buildings T19,
    T52, and T61. This department recovers used solvent collected from
    the BPM production buildings for recycling and reuse. The types of
    equipment used to recover solvents consist of distillation columns,
    evaporators, steam strippers, wash columns, and receivers (tanks).

(k) Waste incinerators -- Liquid solvent waste generated on site and at
    other Lilly sites is burned in the T49 Trane incinerator. A rotary
    kiln incinerator (RKI) is currently under construction and will be
    capable of burning both liquid and solid wastes generated on site
    and at other Lilly sites.

(l) BPM Regenerative Thermal Oxidizers (RTO) general description --
    Emissions from the BPM process operations and some of the BPM
    storage tanks are routed to a common regenerative thermal oxidizer
    (RTO) system. The site has two co-located RTOs that typically
    operate at alternative times. The RTOs are equipped with caustic
    scrubbing systems to remove acid gases. The RTOs reduce CO, VOC, and
    organic HAP emissions, while the scrubbers remove acid gases such as
    SO2, hydrogen chloride (HCl) and hydrogen fluoride (HF).

(m) BPM T79 fume incinerator -- Emissions from the BPM solvent recovery
    operations and some of the BPM storage tanks are routed to the T79
    fume incinerator system. The site maintains two identical T79 fume
    incinerators that typically operate at alternate times. The T79
    incinerators are equipped with caustic scrubbing systems to remove
    acid gases.

(n) BPM wastewater treatment plant -- Wastewater generated by BPM
    production may be voluntarily pretreated by the T79 wastewater
    treatment system before it is transferred to the BPM wastewater
    treatment plant. The T79 wastewater treatment system consists of
    equalization tanks, a neutralization tank, and air stripper columns.
    The exhaust stream from the equalization tanks and air stripper
    columns is vented to the T79 fume incinerators for control of VOC
    and VOHAP emissions.

(o) BPM fugitive emissions -- BPM equipment components such as pumps,
    compressors, agitators, pressure relief devices, sampling connection
    systems, open-ended valves lines, valves, connectors,
    instrumentation systems, control devices, and closed-vent systems
    may generate fugitive emissions. These fugitive emissions are
    minimized through the use of a Leak Detection And Repair (LDAR)
    program.

### **Emission Units and Pollution Control Devices Identified Through the Title V Compliance Transition Program**

This TSD describes facilities and emission units in this operating area
that were identified by the source pursuant to the Title V Compliance
Transition Program under IC 13-7-7 and non-rule policy document
Air-000-NPD \[19 IR 1709\]. Those facilities and emission units are
listed in the specific sections of this TSD relating to individual
operating areas.

**New Emission Units and Pollution Control Equipment** **Receiving
Advanced Source Modification Approval**

Tippecanoe Laboratories has proposed to modify the Bulk Pharmaceutical
Manufacturing operations and supporting areas through a series of
product and process changes, equipment changes, equipment replacement,
and new equipment. The actual nature of these changes is not
specifically defined, but fall into the categories of changes described
in Appendix B. The applicable requirements for these changes, including
Best Available Control Technology, have been defined in the permit and
will apply through the advance approval procedures described in 326 IAC
2-7-6(16).

> This permit serves as advance source modification approval, pursuant
> to 326 IAC 2-2 and 326 IAC 2-7-5(16), of the types of modifications
> and facilities as described in Section F1.

**Insignificant Activities Not Associated with Specific Operating
Areas**

> Most insignificant activities are noted in the specific sections of
> the TSD relating to an individual operating area. The source also
> consists of the following insignificant activities, as defined in 326
> IAC 2-7-1(21), not otherwise listed in specific sections of this TSD:

(a) Natural gas-fired combustion sources with heat input equal to or
    less than ten (10) million Btu per hour;

(b) Propane or liquefied petroleum gas, or butane-fired combustion
    sources with heat input equal to or less than six (6) million
    (6,000,000) Btu per hour;

(c) Equipment powered by internal combustion engines of capacity equal
    to or less than 500,000 Btu/hour, except where total capacity of
    equipment operated by one stationary source exceeds 2,000,000
    Btu/hour;

(d) A gasoline fuel transfer and dispensing operation handling less than
    or equal to 1,300 gallons per day, such as filling of tanks,
    locomotives, automobiles, having a storage capacity less than or
    equal to 10,500 gallons.

(e) 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;

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

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

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

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

(j) Degreasing operations that do not exceed 145 gallons per 12 months;
    except if subject to 326 IAC 20-6;

(k) Cleaners and solvents with a combined use less than or equal to 145
    gallons per 12 months characterized having a vapor pressure equal to
    or less than 2 kPa, 15 mm Hg, or 0.3 psi measured at 38C (100F); or
    having a vapor pressure equal to or less than 0.7 kPa, 5 mmHg, or
    0.1 psi measured at 20C (68F).

(l) Closed loop heating and cooling systems;

(m) Structural and bridge fabrication activities including cutting
    200,000 linear feet or less of one inch plate or equivalent, or
    using 80 tons or less of welding consumables;

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

(o) 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-site sewage
    treatment facility;

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

(q) Noncontact cooling tower systems with forced and induced draft
    cooling tower system not regulated under a NESHAP;

(r) Replacement or repair of electrostatic precipitators, bags in
    baghouses and filters in other air filtration equipment;

(s) Heat exchanger cleaning and repair;

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

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

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

(w) Covered conveyors for coal or coke conveying of less than or equal
    to 360 tons per day;

(x) Coal bunker and coal scale exhausts and associated dust collector
    vents;

(y) Asbestos abatement projects regulated by 326 IAC 14-10;

(z) 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;

(a) 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;

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

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

(d) Emergency generators including gasoline generators not exceeding 110
    horsepower, diesel generators not exceeding 1600 horsepower; and
    natural gas turbines or reciprocating engines not exceeding 16,000
    horsepower;

(e) Stationary fire pumps;

(f) Grinding and machining operations controlled with fabric filters,
    scrubbers, mist collectors, wet collectors and electrostatic
    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 the following:
    deburring; buffing; polishing; abrasive blasting; pneumatic
    conveying; and woodworking operations;

(g) Purge double block and bleed valves;

(h) Filter or coalescer media changeout;

(i) Vents from ash transport systems not operated at positive pressure;

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

(k) Research and development activities defined in 326 IAC 2-7-1(21)(E);

(l) Farm operations; and

(m) Activities with emissions equal to or less than thresholds listed in
    326 IAC 2-7-1(21)(A)-(C) including:

    1.  T100 Unit 1 Drumming Operations;

    2.  T99/T100 Solids Particle Sizing Equipment (mills and delumpers);

    3.  Portable Cleaning and Collection Tanks;

    4.  T4 Sulfuric Acid Tank;

    5.  T47 Trash Transfer;

    6.  Sump Tanks;

    7.  T116 Hydrogen Chloride Storage Tank;

    8.  T14 Ranney Well;

    9.  T99 Ethylene Glycol Expansion Tank System

    10. Fermentation and Purification Activities; and

    11. T71 Development Engineering Facility.

**Existing Approvals**

> The source has been operating under previous approvals including, but
> not limited to, operating permits, registrations, construction
> permits, and source modification approvals. The specific listing of
> existing approvals and how the conditions in those approvals are
> incorporated into this permit are described in the various sections of
> this TSD relating to specific operating areas.
>
> Although incorporation of individual terms are discussed in the
> sections of the TSD specifically relating to an operating, generally
> the following concepts were followed:

(a) Conditions from operating permits issued pursuant to the
    now-repealed 326 IAC 2-1-4 are not incorporated into this permit
    because those conditions are not applicable requirements, as defined
    by 326 IAC 2-7-1(6).

(b) Conditions from registrations, construction permits, and source
    modification approvals for areas that will be operating under the
    flexible permit provisions \[Bulk Pharmaceutical Manufacturing, BPM
    support, and waste incineration\] are not incorporated into this
    permit because those conditions have been replaced by the issuance
    of the combined Part 70 and PSD permit.

(c) Conditions from registrations, construction permits, and source
    modification approvals for areas that will not be operating under
    the flexible permit provisions \[Utilities, Fermented Products, and
    Miscellaneous Operations\] were evaluated on a case-by-case basis to
    determine whether the condition is a relevant and valid applicable
    requirement. In some cases, conditions from these existing approvals
    are modified or deleted by this Part 70 permit.

> The TSD for each operating area will contain a table or similar
> discussion that describes the proposed treatment of these conditions

**Enforcement Issue**

> There are no enforcement actions pending.

**Recommendation**

> The staff recommends to the Commissioner that the combined Part 70
> permit and PSD permit be approved. This recommendation is based on the
> following facts and conditions:
>
> Unless otherwise stated, information used in this review was derived
> from the application and additional information submitted by the
> applicant.
>
> An administratively complete Part 70 permit application for the
> purposes of this review was received on October 10, 1996. Various
> updates to the Part 70 permit application were received between 1997
> and 2003. The flexible PSD permit application, which shall be
> incorporated as part of the Part 70 permit, was received on May 15,
> 2002. Additional information to this application was received in 2002
> and 2003.

**Emission Calculations**

> The calculation methodologies submitted by the applicant have been
> verified and found to be accurate and correct. These calculation
> methodologies can be found in the documentation accompanying the Part
> 70 permit application for the source.

**Potential To Emit**

> Pursuant to 326 IAC 2-1.1-1(16), Potential to Emit (PTE) is defined as
> "the maximum capacity of a stationary source to emit any air pollutant
> under its physical and operational design. Any physical or operational
> limitation on the capacity of a source to emit an air pollutant,
> including air pollution control equipment and restrictions on hours of
> operation or type or amount of material combusted, stored, or
> processed shall be treated as part of its design if the limitation is
> enforceable by the U. S. EPA."
>
> This table reflects the PTE of the entire source before controls.
> Control equipment is not considered federally enforceable until it has
> been required in a federally enforceable permit.

  -------------------------------- --------------------------------------
  Pollutant                        Potential To Emit (tons/year)

  PM                               \> 100 tpy

  PM-10                            \> 100 tpy

  SO~2~                            \>100 tpy

  VOC                              \>100 tpy

  CO                               \>100 tpy

  NOx                              \>100 tpy

  Combined HAPs                    \>25 tpy

  Individual HAPs                  Several \> 10 tpy
  -------------------------------- --------------------------------------

> Note: For the purpose of determining Title V applicability for
> particulates, PM-10, not PM, is the regulated pollutant in
> consideration.
>
> \(a\) The potential to emit (as defined in 326 IAC 2-1.1-1(16)) of CO,
> NOx, PM-10, SO2 and VOC are equal to or greater than 100 tons per
> year. Therefore, the source is subject to the provisions of 326 IAC
> 2-7.
>
> and
>
> \(b\) The potential to emit (as defined in 326 IAC 2-1.1-1(16)) of any
> single HAP is equal to or greater than ten (10) tons per year and the
> potential to emit (as defined in 326 IAC 2-7-1(29)) of a combination
> HAPs is greater than or equal to twenty-five (25) tons per year.
> Therefore, the source is subject to the provisions of 326 IAC 2-7.
>
> and
>
> \(c\) Fugitive Emissions
>
> Since this type of operation is one of the twenty-eight (28) listed
> source categories under 326 IAC 2-2, the fugitive emissions are
> counted toward determination of PSD applicability.

**Actual Emissions**

The following table shows the actual emissions from the source. This
information reflects the 2001 OAQ emission data from the annual emission
statement submitted by the source.

+--------------------------------+-------------------------------------+
| Pollutant                      | Actual Emissions (tons/year)        |
+--------------------------------+-------------------------------------+
| PM                             | 386.2                               |
+--------------------------------+-------------------------------------+
| PM-10                          | 386.2                               |
+--------------------------------+-------------------------------------+
| SO~2~                          | 1589.5                              |
+--------------------------------+-------------------------------------+
| VOC                            | 94.1                                |
+--------------------------------+-------------------------------------+
| CO                             | 182.7                               |
+--------------------------------+-------------------------------------+
| NO~x~                          | 377.5                               |
+--------------------------------+-------------------------------------+
| HAP\* (specify)                | 0.885                               |
|                                |                                     |
| Chlorine                       | 6.39                                |
|                                |                                     |
| Hydrochloric Acid              | 5.69                                |
|                                |                                     |
| Methylene Chloride             |                                     |
+--------------------------------+-------------------------------------+

> \* Report of Billable HAPs Only

**Net Emissions Increase Associated with Modification of BPM and BPM
support operations**

This permit combines the issuance of a Part 70 permit for the entire
source and a PSD permit for modifications to the Bulk Pharmaceutical
Manufacturing \[BPM\] area and its supporting operations.

The table below summarizes the net emissions increase calculated
pursuant to 326 IAC 2-2.

+--------------+--------------+--------------+----------+------------+
| *            | *            | **Past       | **Future | **Net      |
| *Pollutant** | *Significant | actual       | p        | emissions  |
|              | net emission | emissions**  | otential | increase** |
|              | increase     |              | emi      |            |
|              | rate**       | **(1999-2000 | ssions** |            |
|              |              | avg.)**      |          |            |
+--------------+--------------+--------------+----------+------------+
|              | **(tpy)**    | **(tpy)**    | *        | **(tpy)**  |
|              |              |              | *(tpy)** |            |
+--------------+--------------+--------------+----------+------------+
| Carbon       | 100          | 26.2         | 150      | 124        |
| monoxide     |              |              |          |            |
+--------------+--------------+--------------+----------+------------+
| Fluorides    | 0.3          | 0.4          | 6        | 5.6        |
+--------------+--------------+--------------+----------+------------+
| Lead         | 0.6          | 0.12         | 0.24     | 0.12       |
+--------------+--------------+--------------+----------+------------+
| Nitrogen     | 40           | 70.6         | 300      | 229        |
| oxides       |              |              |          |            |
+--------------+--------------+--------------+----------+------------+
| Particulate  | 25           | 7.70         | \<25     | 7.2        |
| matter - TSP |              |              |          |            |
+--------------+--------------+--------------+----------+------------+
| Particulate  | 15           | 7.70         | \<15     | 7.2        |
| matter -     |              |              |          |            |
| PM10         |              |              |          |            |
+--------------+--------------+--------------+----------+------------+
| SO2          | 40           | 46.3         | 300      | 254        |
+--------------+--------------+--------------+----------+------------+
| VOC          | 40           | 92.4         | 300      | 207.6      |
+--------------+--------------+--------------+----------+------------+
| Asbestos     | 0.007        | 0.0          | \<0.007  | \<0.007    |
+--------------+--------------+--------------+----------+------------+
| Beryllium    | 0.0004       | 0.0          | 0.00034  | \<0.0004   |
+--------------+--------------+--------------+----------+------------+
| Mercury      | 0.1          | 0.003        | 0.02     | 0.02       |
+--------------+--------------+--------------+----------+------------+
| Vinyl        | 1            | negligible   | ne       | negligible |
| chloride     |              |              | gligible |            |
+--------------+--------------+--------------+----------+------------+
| Sulfuric     | 7            | 0.02         | 4.0      | 4.0        |
| acid mist    |              |              |          |            |
+--------------+--------------+--------------+----------+------------+
| Hydrogen     | 10           | 0.32         | 0.6      | 0.3        |
| sulfide      |              |              |          |            |
+--------------+--------------+--------------+----------+------------+
| Total        | 10           | 0.32         | 0.6      | 0.3        |
| reduced      |              |              |          |            |
| sulfur       |              |              |          |            |
| compounds    |              |              |          |            |
+--------------+--------------+--------------+----------+------------+
| Reduced      | 10           | negligible   | ne       | negligible |
| sulfur       |              |              | gligible |            |
| compouds     |              |              |          |            |
+--------------+--------------+--------------+----------+------------+
| MWC organics | 3.5 x 10^-6^ | N/A          | N/A      | N/A        |
+--------------+--------------+--------------+----------+------------+
| MWC acid     | 40           | N/A          | N/A      | N/A        |
| gases        |              |              |          |            |
+--------------+--------------+--------------+----------+------------+
| MWC metals   | 15           | N/A          | N/A      | N/A        |
+--------------+--------------+--------------+----------+------------+
| Landfill     | 50           | N/A          | N/A      | N/A        |
| gases        |              |              |          |            |
| /non-methane |              |              |          |            |
| organic      |              |              |          |            |
| compounds    |              |              |          |            |
+--------------+--------------+--------------+----------+------------+
| Ozone        | 100          | 4.3          | 4.3      | 0          |
| depleting    |              |              |          |            |
| substances   |              |              |          |            |
+--------------+--------------+--------------+----------+------------+

**County Attainment Status**

The source is located in Tippecanoe County.

  ---------------------------------- ------------------------------------
  Pollutant                          Status (attainment, maintenance
                                     attainment, or unclassifiable;
                                     severe, moderate, or marginal
                                     nonattainment*)*

  PM-10                              Attainment

  SO~2~                              Attainment

  NO~2~                              Attainment

  Ozone                              Attainment

  CO                                 Attainment

  Lead                               Attainment
  ---------------------------------- ------------------------------------

> \(a\) Volatile organic compounds (VOC) are precursors for the
> formation of ozone. Therefore, VOC emissions are considered when
> evaluating the rule applicability relating to the ozone standards.
> Tippecanoe County has been designated as attainment or unclassifiable
> for ozone. Therefore, VOC emissions were reviewed pursuant to the
> requirements for Prevention of Significant Deterioration (PSD), 326
> IAC 2‑2.

\(b\) Tippecanoe County has been classified as attainment or
unclassifiable for CO, lead, NO2, PM10, and SO2. Therefore, these
emissions were reviewed pursuant to the requirements for Prevention of
Significant Deterioration (PSD), 326 IAC 2‑2.

> \(c\) Fugitive Emissions
>
> Since this type of operation is one of the twenty-eight (28) listed
> source categories under 326 IAC 2-2, the fugitive emissions are
> counted toward determination of PSD applicability.

**Part 70 Permit Conditions**

> This source is subject to the requirements of 326 IAC 2-7, pursuant to
> which the source has to meet the following:
>
> \(a\) Emission limitations and standards, including those operational
> requirements and limitations that assure compliance with all
> applicable requirements at the time of issuance of Part 70 permits.
>
> \(b\) Monitoring and related record keeping requirements which assume
> that all reasonable information is provided to evaluate continuous
> compliance with the applicable requirements.

**Federal Rule Applicability -- New Source Performance Standards**
(NSPS)

\[40 CFR Part 60 and 326 IAC 12\]

(a) **NSPS applicable to source:**

    1.  **Subpart A -- General Provisions:** The provisions of 40 CFR
        60, Subpart A apply to the facilities described in item (2)
        below except when otherwise specified in the relevant Subpart.

    2.  **Subpart Kb -- Solvent Storage Tanks:** This source is subject
        to 40 CFR Part 60, Subpart Kb, which applies to solvent storage
        tanks. The specific applicability of this NSPS and the
        requirements incorporated into this permit are discussed in the
        relevant portions of this TSD.

(b) **NSPS not applicable to source:** IDEM has determined that the
    following NSPS are not applicable to this source:

    1.  **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/hr in heat
        input capacity. \[40 CFR 60.40(a)(1)\]

    2.  **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.  **Subpart Dc -- Industrial-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.  **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.  **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.  **Subparts VV, III, NNN and RRR -- 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 product, co-product, or by-product, a
        chemical 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.  **All other NSPS:** This source is not subject to other NSPS
        requirements not listed here because the source does not own or
        operate the affected facilities subject to those NSPS.

**Federal Rule Applicability -- Section 111(d) Emission Guidelines**

\[40 CFR Part 60 and 326 IAC 11\]

(a) **Emissions guidelines not applicable to source:** IDEM has
    determined that the 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
    required to have a permit pursuant to Section 3005 of the Solid
    Waste Disposal Act. \[40 CFR 60.32e(d) and 40 CFR 60.2555(g)\]

**Federal Rule Applicability -- National Emission Standards for
Hazardous Air Pollutants (NESHAPs)**

\[40 CFR Part 61 and 326 IAC 14\]

(a) **Part 61 NESHAPs applicable to source:**

    1.  **Subpart A -- General Provisions:** The provisions of 40 CFR 61
        Subpart A - General Provisions, apply to the facilities
        described in items (2) through (5) below, except when otherwise
        specified in the relevant Subpart.

> \(2\) **Subpart M -- Asbestos:** This source is subject to 40 CFR Part
> 61, Subpart M and 326 IAC 14-10, which applies to, among other things,
> demolition and renovation operations and asbestos containing
> materials. The requirements of this NESHAP are reflected in Condition
> C.7 of this permit.
>
> \(3\) **Subpart V - Fugitive Emissions From Equipment Leaks:** This
> source has elected to comply with the Off-Site Waste and Recovery
> NESHAPs \[40 CFR 63, Subpart DD\] in part by following the
> requirements of 40 CFR Part 61, Subpart V and 326 IAC 14-8. This
> NESHAP establishes standards for controlling fugitive emissions from
> equipment leaks. The specific applicability of this NESHAP and the
> requirements incorporated into this permit are discussed in Section
> E.1 of this TSD.
>
> \(4\) **Subpart FF -- Benzene Waste Operations:** This source is
> subject to 40 CFR Part 61, Subpart FF, which applies to benzene waste
> operations. The specific applicability and the requirements
> incorporated into this permit are discussed in Sections D.12 (T49
> Liquid Incinerator) and D.13 (T149 Rotary Kiln Solids-Liquid
> Incinerator) of this TSD.

(b) **Part 61 NESHAPs not applicable to source:** IDEM has determined
    that the following NESHAPs are not applicable to this source:

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

    2.  **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 plant sludge in its incinerators.

    3.  **Other Part 61 NESHAP:** This source is not subject to other
        Part 61 NESHAP requirements not listed here because the source
        does not own or operate the affected facilities subject to those
        NESHAPs.

**Federal Rule Applicability -- National Emission Standards for
Hazardous Air Pollutants** (NESHAPs)

\[40 CFR Part 63 and 326 IAC 20\]

(a) **Part 63 NESHAPs applicable to source:**

    1.  **Subpart A -- General Provisions:** The provisions of 40 CFR
        63, Subpart A apply to the facilities described in items (2)
        through (5) below, except when otherwise specified in the
        relevant Subpart.

    2.  **Subpart B -- Case-by-case MACT determination:** This source
        may be subject to 40 CFR Part 63, Subpart B, Sections 63.50,
        through 63.56. This source includes facilities potentially
        subject to NESHAP standards for which USEPA has not promulgated
        final standards. If the USEPA fails to promulgate final NESHAPs
        by the applicable deadlines, this source must submit an
        application for a case-by-case determination of Maximum
        Achievable Control Technology (MACT). This source submitted the
        Part 1 MACT applications, pursuant to 40 CFR 63.52 and 63.53 on
        May 14, 2002. \[40 CFR 63.50\]

    3.  **Subpart I -- Equipment Leaks:** This source is subject to 40
        CFR Part 63, Subpart I and 326 IAC 20-12, which applies to
        pharmaceutical production processes using carbon tetrachloride
        or methylene chloride. The source may comply with this NESHAP by
        complying with equipment leak standards in 40 CFR Part 63
        Subpart H (Equipment Leaks) or 40 CFR Part 63 Subpart GGG
        (Pharmaceutical Production MACT). The source has elected to
        comply with Subpart I by following the requirements of Subpart
        GGG and streamlined permit conditions reflecting the most
        stringent of applicable equipment leak standards. The details of
        these requirements are discussed in Section E.1 (LDAR) of this
        TSD.

    4.  **Subpart DD -- Off-site Waste and Recovery Operations:** This
        source is subject to 40 CFR 63, Subpart DD and 326 IAC 20-23
        which applies to facilities treating and recovering wastes
        originating from other sites. This NESHAP establishes standards
        for controlling point source and fugitive emissions. The
        specific applicability of this NESHAP and the requirements
        incorporated into this permit are discussed in Sections D.7
        (Solvent Recovery), D.10 (Waste Tanks), and D.11 (Waste
        Containers) of this TSD.

    5.  **Subparts OO, PP, QQ, RR, SS, TT, UU, VV, WW:** To the extent
        that these general MACT requirements apply, the source shall
        demonstrate compliance with these generic standards through
        compliance with the requirements established in the Pharma MACT,
        HWC MACT, or OSWRO MACT, as applicable. Specific applicability
        of 40 CFR Part 63 Subparts OO \[Level 1 Tanks\], PP
        \[Containers\], QQ \[Surface Impoundments\], RR \[Individual
        Drain Systems\], SS \[Closed vent systems and control devices\],
        TT \[Equipment leaks -- Level 1\], UU \[Equipment leaks -- Level
        2\], VV \[Separators\], and WW \[Storage Tanks -- Level 2\] (326
        IAC 20-35 through 20-43) are discussed in Sections D.8
        (Individual Drain Systems), D.9 (Solvent Storage Tanks), D.10
        (Waste Tanks), D.11 (Waste Containers), D.14 (RTO Control System
        and associated Closed Vent System), D.15 (T79 Fume Incinerator
        and associated Closed Vent System), and E.1 (LDAR) of this TSD.

    6.  **Subpart EEE -- Hazardous Waste Combustors:** This source is
        subject to 40 CFR Part 63, Subpart EEE and 326 IAC 20-28, which
        applies to hazardous waste incinerators, among other things.
        This NESHAP establishes emission limitations and work practices
        for controlling point source emissions. The specific
        applicability of this NESHAP and the requirements incorporated
        into this permit are discussed in Sections D.12 (T49 Liquid
        Incinerator) and D.13 (T149 Rotary Kiln Liquids-Solid
        Incinerator) of this TSD.

    7.  **Subpart GGG -- Pharmaceuticals Production:** This source is
        subject to 40 CFR Part 63, Subpart GGG, which applies to
        pharmaceutical manufacturing facilities. This NESHAP establishes
        emission limitations and work practice standards for controlling
        point source and fugitive emissions. The specific applicability
        of the various aspects of this NESHAP and the requirements
        incorporated into this permit are discussed in Sections D.6 (BPM
        Operations), D.7 (BPM Solvent Recovery Operations), D.8 (BPM
        Wastewater and BPM Individual Drain System Operations), D.9 (BPM
        Solvent Storage Tanks), D.10 (Waste Tanks), and D.11 (BPM Waste
        Containers) of this TSD.

(b) **Part 63 NESHAPs not applicable to source:** IDEM has determined
    that the following NESHAPs are not applicable to this source:

    1.  **Subparts F and G -- Synthetic 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 listed in table 2 of Subpart F. \[40 CFR
        63.100(b)\]

    2.  **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 sterilization
        operations. \[40 CFR 63.360\]

    3.  **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. \[40 CFR 63.400\]

    4.  **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. \[40 CFR 63.460\]

    5.  **Subpart YY --** **Generic MACT categories:** This source is
        not subject to 40 CFR Part 63, Subpart YY and 326 IAC 20-44
        because the source is not one of the source categories described
        in 40 CFR 63.1103. \[40 CFR 63.1100\]

    6.  **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 any pesticide
        active ingredient process units or associated equipment as
        described in 40 CFR 63.1360. \[40 CFR 63.1360\]

    7.  **Other Part 63 NESHAPs:** This source is not subject to other
        NESHAP requirements not listed here because the source does not
        own or operate the affected facilities subject to those NESHAPs.

**Federal Rule Applicability -- Other Provisions**

(a) **Part 64 -- Compliance Assurance Monitoring:** The provisions of 40
    CFR Part 64 are not applicable to this source because this is the
    initial issuance of a Part 70 permit to this source, and the source
    submitted a complete Part 70 permit application prior to April
    20, 1998. \[40 CFR 64.5\]

(b) **Part 68 -- Chemical Accident Prevention:** The provisions of 40
    CFR Part 68 and 326 IAC 20-2 are applicable to this source because
    the source may have more than a threshold quantity of a substance
    regulated by Part 68. The source is required to prepare a Risk
    Management Plan meeting the requirements of Part 68. The source
    submitted its most recent plan on September 15, 2000.

(c) **Part 70 -- Operating Permits:** This source is a major source, as
    defined by 40 CFR 70.2 and 326 IAC 2-7-1, and is subject to the Part
    70 operating permits program. This permit serves as the Part 70
    operation permit for the source.

(d) **Parts 72-78 -- Acid Rain Program Provisions:** This source is not
    an affected source subject to the Acid Rain Program Provisions found
    in 40 CFR Parts 72-78 and 326 IAC 21.

(e) **Part 82 -- Protection of Stratospheric Ozone:** This source
    conducts maintenance of appliances containing ozone depleting
    substances, and therefore is subject to the recycling and emission
    reduction requirements of 40 CFR Part 82, Subpart F. Condition C.18
    of this permit describes the requirements of these provisions.

(f) **Other Clean Air Act Regulations:** This source is not subject to
    other Clean Air Act requirements not listed in this permit because
    the source does not own or operate the affected facilities subject
    to those requirements nor does it conduct the activities subject to
    those requirements.

**State Rules Applicability**

a.  **326 IAC 1-5-2 (Emergency Reduction Plans):** The source has
    submitted its most recent Emergency Reduction Plan (ERP) on December
    13, 2000. The ERP has been verified to fulfill the requirements of
    326 IAC 1-5-2 (Emergency Reduction Plans). Condition C.11 of this
    permit describes the requirements of these provisions.

b.  **326 IAC 1-6-3 (Preventive Maintenance Plan):** The source is
    required to develop and maintain Preventive Maintenance Plans (PMP)
    for some specific facilities listed in this permit. General PMP
    requirements are described in Section B of this permit, and specific
    PMP requirements for individual facilities are described in specific
    sections of the permit where this requirement is applicable.

c.  **326 IAC 1-7 (Stack Height Provisions):** This source includes
    facilities subject to the minimum stack height requirements of 326
    IAC 1-7. The stack height requirements for the individual facilities
    subject to these requirements are described in the specific sections
    of the permit where this requirement is applicable.

d.  **326 IAC 2 (Permit Review Rules):** This source is subject to the
    permit review rules in 326 IAC 2 as described below.

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1.  **326 IAC 2-1.1 -- General Provisions:** Except where other rules in
    326 IAC 2 require otherwise, the provisions of 326 IAC 2-1.1apply to
    the entire source.

2.  **326 IAC 2-2 -- Prevention of Significant Deterioration \[PSD\] and
    326 IAC 2-2.5 -- Pollution Control Projects:** This source is a
    major stationary source, as defined in 326 IAC 2-2-1, and is
    therefore subject to PSD requirements when major modifications occur
    at the source. This permit serves as a PSD permit for the
    modifications that will occur in Bulk Pharmaceutical Manufacturing
    \[BPM\] operations, BPM support operations, and the waste
    incinerators during the term of this permit.

> The following aspects of the PSD permitting program were reviewed and
> evaluated and determined to satisfy the PSD permitting requirements:

-   Best Available Control Technology \[326 IAC 2-2-3\];

-   Air Quality Analysis \[326 IAC 2-2-4(a) and 326 IAC 2-2-5\],

-   Evaluation of PSD increment consumption \[326 IAC 2-2-6\]; and

-   Additional impacts analysis \[326 IAC 2-2-7\].

> The detailed analyses of the BACT review and Air Quality Modeling
> results can be found in Appendix C and Appendix D of this TSD,
> respectively.

1.  **326 IAC 2-3 -- Emission Offset:** This source is located in an
    area designated as attainment or unclassifiable for all criteria
    pollutants. Therefore, the requirements of 326 IAC 2-3 do not apply
    to this source.

2.  **326 IAC 2-4.1 -- Major Sources of Hazardous Air Pollutants
    \[HAPs\]:** This source is a major source of hazardous air
    pollutants. If the source proposes to construct or reconstruct a
    major source of HAPs, as defined in 40 CFR 63.41, and that major
    source is not excluded pursuant to 326 IAC 2-4.1(b), then the source
    must comply with the requirements of 326 IAC 2-4.1-1(c) and (d) for
    case-by-case Maximum Achievable Control Technology determinations.
    The source does not anticipate constructing or reconstructing a
    major source of HAPs that will be subject to these requirements.

3.  **326 IAC 2-5.1 -- Construction of New Sources:** This source is an
    existing source, and therefore cannot be considered to construct a
    "new source" as defined by 326 IAC 2-1.1-1(10). Therefore, 326 IAC
    2-5.1 does not apply to this source.

4.  **326 IAC 2-7 -- Part 70 Operating Permit Program:** This source is
    a major source, as defined by 326 IAC 2-7-1, and is therefore,
    subject to the requirements of 326 IAC 2-7.

5.  **326 IAC 2-13 -- Interim operating permit revision approvals:**
    This source is eligible to seek interim operating permit revision
    approvals for minor modifications that may occur at the source.

6.  **Other permit review rules:** This source is an existing source
    operating under a Part 70 permit, and therefore, is not subject to
    the requirements of 326 IAC 2-5.5 \[Registrations\], 326 IAC 2-6.1
    \[Minor Source Operating Permit Program\], 326 IAC 2-8 \[Federally
    Enforceable State Operating Permit Program\], 326 IAC 2-9 \[Source
    Specific Operating Agreement Program\], 326 IAC 2-10 \[Permit by
    Rule\], 326 IAC 2-11 \[Permit by Rule for Specific Source
    Categories\], 326 IAC 2-12 \[General Permits\], and 326 IAC 2-14
    \[Portable Sources\].

> \(e\) **326 IAC 2-6 (Emission Reporting):** This source is subject to
> 326 IAC 2-6 (Emission Reporting), because it has the potential to emit
> more than one hundred (100) tons per year) of carbon monoxide,
> nitrogen dioxides, particulate matter, sulfur dioxide, and volatile
> organic compounds. Pursuant to this rule, the owner/operator of the
> source must annually submit an emission statement for the source. The
> annual statement must be received by July 1 of each year and contain
> the minimum requirement as specified in 326 IAC 2-6-4. The submittal
> should cover the period defined in 326 IAC 2-6-2(8)(Operating Year).
>
> \(f\) **326 IAC 3 (Monitoring requirements):** This source includes
> facilities subject to the continuous monitoring, source sampling and
> fuel sampling provisions of 326 IAC 3. The specific monitoring, source
> sampling, and fuel sampling requirements applicable to the source are
> described in specific sections of this permit.
>
> \(g\) **326 IAC 4 (Burning regulations):** This source is subject to
> two aspects of 326 IAC 4. The open burning limitations and standards
> in 326 IAC 4-1 are applicable to the entire source. These limitations
> are described in Condition C.3 of the permit.
>
> 326 IAC 4-2 establishes particulate matter limitations and other
> standards for incinerators. This rule applies to incinerators burning
> solid or liquid wastes. It does not apply to incinerators used to
> reduce emissions from process operations. Therefore, this rule is not
> applicable to the Regenerative Thermal Oxidizers or T79 Fume
> Incinerators.
>
> Because the T49 Liquid Waste Incinerator and the T149 Liquid/Solid
> Waste Incinerator are subject to the requirements of 40 CFR Part 63,
> Subpart EEE \[Hazardous Waste Combustor MACT\], these incinerators are
> not subject to the requirements of 326 IAC 4-2. These incinerators,
> however, are subject to an older version of 326 IAC 4-2 incorporated
> into the State Implementation Plan \[SIP\]. This permit includes
> specific conditions that describe the SIP-approved requirements
> applicable to these incinerators. The permit also states that the
> current SIP-approved requirements will expire if USEPA approves the
> current version of 326 IAC 4-2 into the SIP.
>
> \(h\) **326 IAC 5-1 (Opacity Limitations):** This source includes
> facilities subject to 326 IAC 5, which establishes opacity (visible
> emissions) standards for operations emitting particulate matter. For
> some operations, such as boilers, where opacity limitations are more
> complex, the specific section of the permit addressing those
> operations will include conditions describing the opacity limitations.
> For all other operations emitting particulate matter, the opacity
> requirements are described in a general condition \[Condition C.2\].
>
> \(i\) **326 IAC 6 (Particulate Rules)**

(1) **326 IAC 6-1 -- Nonattainment Area Limitations:** This source is
    located in an attainment area for particulate matter. Therefore, 326
    IAC 6-1 does not apply to any facilities at this source.

(2) **326 IAC 6-2 -- Particulate Emission Limitations for Sources of
    Indirect Heating:** This source includes boilers that are subject to
    the requirements of this rule. The specific limitations and other
    requirements applicable to these facilities are described in
    Sections D.1 (Utilities Operations) of this TSD.

(3) **326 IAC 6-3 -- Process Operations:** This rule establishes
    particulate matter limits for manufacturing processes that emit
    particulate matter. This source includes several facilities subject
    to the requirements of this rule. The permit includes specific
    conditions, including expression of the particulate matter emission
    limitations, incorporating this requirement for manufacturing
    processes and emission units in various locations of the plant site.
    As a result, this requirement will be described in multiple
    locations in the permit. In addition, this permit includes a general
    condition \[Condition C.1\], that generally describes the emission
    limitation for all other manufacturing processes subject to 326 IAC
    6-3 which are not described in detail in D sections of the permit.
    Administrative, maintenance, research and development, and other
    support activities conducted at the source that are not
    manufacturing are not subject to this rule.

(4) **326 IAC 6-4 -- Fugitive Dust Emissions:** This source is subject
    to the fugitive dust limitations in 326 IAC 6-4. The source may not
    allow fugitive emissions to cross the property boundaries of the
    site, including easements and rights-of-way, in a manner that
    violates this rule. Condition C.4 of this permit describes the
    requirements of this rule in greater detail.

(5) **326 IAC 6-5 -- Fugitive Particulate 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.

> \(j\) **326 IAC 7 (Sulfur dioxide rules):** This source includes
> boilers that are subject to the requirements of 326 IAC 7. The
> specific limitations and other requirements applicable to these
> facilities are described in Section D.1 (Utilities Operations) of this
> TSD. No other emission units are subject to the requirements of this
> rule.
>
> \(k\) **326 IAC 8 (Volatile Organic Compound Rules):** This source is
> subject to the VOC control rules in 326 IAC 8 as described below.

1.  **326 IAC 8-1 -- General Provisions:** Because this source operates
    facilities subject to rules in 326 IAC 8, the General Provisions in
    326 IAC 8-1apply to the source. Where a specific provision of 326
    IAC 8-1 is applicable to facilities at this source, those provisions
    will be contained in a specific section of the permit and described
    in the appropriate section of the TSD. Sections 326 IAC 8-1-7,
    8-1-10, 8-1-11, and 8-1-12 are not applicable to this source.

2.  **326 IAC 8-3 -- Organic Solvent Degreasing Operations:** This
    source does not own or operate open top degreasing facilities
    containing organic solvent. Therefore, the requirements of 326 IAC
    8-3-3/326 IAC 8-3-6 do not apply.

3.  **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.

4.  **326 IAC 8-5-3 -- Synthesized Pharmaceutical Manufacturing
    Operations:** This source includes various operations subject to the
    requirements of 326 IAC 8-5-3. This rule establishes emission
    limitations and work practices for production and support equipment
    engaged in manufacturing pharmaceuticals by chemical synthesis. The
    permit includes specific conditions incorporating these
    requirements. The permittee has requested that most of the
    requirements of this rule be "streamlined" into permit conditions
    incorporating the requirements of the Pharmaceutical Production MACT
    \[40 CFR Part 63, Subpart GGG\] and the BACT emission limitations
    and standards established as part of the BACT PSD review described
    in Appendix C this TSD. The specific requirements of this rule, and
    the streamlining of its requirements into other permit conditions
    are described in Appendix A of this TSD.

5.  **326 IAC 8-6 -- Organic Solvent 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.

6.  **Other rules in 326 IAC 8**: This source is not subject to other
    requirements in 326 IAC 8 not listed here because the source does
    not own or operate the affected facilities subject to those rules.

> \(l\) **326 IAC 9 (Carbon Monoxide Rules):** Because the T49 Liquid
> Waste Incinerator and T149 Liquid/Solid Waste Incinerator are subject
> to the requirements of 40 CFR 63, Subpart EEE \[Hazardous Waste
> Combustor MACT\], these incinerators are not subject to the
> requirements of 326 IAC 9-1. These incinerators, however, are subject
> to an older version of 326 IAC 9-1 incorporated into the State
> Implementation Plan \[SIP\]. This permit includes specific conditions
> that describe the SIP-approved requirements applicable to these
> incinerators. The permit also states that the current SIP-approved
> requirements will expire if USEPA approves the current version of 326
> IAC 9-1 into the SIP.

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

\(n\) **326 IAC 11 (Emission Limitations for Specific Types of
Operations):** This source does not contain any emission units described
in 326 IAC 11. Therefore, the source is not subject to the requirements
of those rules.

\(o\) **326 IAC 12 (New Source Performance Standards):** The
applicability of the New Source Performance Standards, as embodied in
Indiana air quality regulations, is described in greater detail in the
section of this TSD addressing the federal NSPS program.

\(p\) **326 IAC 14 (Emission Standards for Hazardous Air Pollutants):**
The applicability of these Emission Standards for Hazardous Air
Pollutants, as embodied in Indiana air quality regulations, is described
in greater detail in the section of this TSD addressing the federal Part
61 NESHAPs program.

\(q\) **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.

> \(r\) **326 IAC 20 (Hazardous Air Pollutants):** The applicability of
> Part 63 National Emission Standards for Hazardous Air Pollutants, as
> embodied in 326 IAC 20, is described in greater detail in the section
> of this TSD addressing the federal Part 63 NESHAPs program.

\(s\) **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.

\(t\) **326 IAC 22 (Emission Standards for Hazardous Air Pollutants):**
The applicability of Part 82 Stratospheric Ozone Protection program, as
embodied in 326 IAC 22, is described in greater detail in the section of
this TSD addressing the Part 82 program.

## Assessment of Hazardous Air Pollutant Impacts

> The proposed modification may increase hazardous air pollutant
> emissions. As a result, IDEM conducted an assessment of the impacts of
> hazardous air pollutant emissions from the source. The results of that
> assessment are found in Appendix D to this TSD.

**Testing Requirements**

The detailed testing requirements for individual facilities are
described in Appendix A of this TSD.

**Compliance Requirements**

> Permits issued under 326 IAC 2-7are required to ensure that source can
> demonstrate compliance with applicable state and federal rules on a
> more or less continuous basis. All state and federal rules contain
> compliance provisions, however, these provisions do not always fulfill
> the requirement for a more or less continuous demonstration. When this
> occurs IDEM, OAQ, in conjunction with the source, must develop
> specific conditions to satisfy 326 IAC 2-7-5. As a result, compliance
> requirements are divided into two sections: Compliance Determination
> Requirements and Compliance Monitoring Requirements.

Compliance Determination Requirements in Section D of the permit are
those conditions that are found more or less directly within state and
federal rules and the violation of which serves as grounds for
enforcement action. If these conditions are not sufficient to
demonstrate continuous compliance, they will be supplemented with
Compliance Monitoring Requirements, also located in Section D of the
permit. Unlike Compliance Determination Requirements, failure to meet
Compliance Monitoring conditions would serve as a trigger for corrective
actions and not grounds for enforcement action. However, a violation in
relation to a compliance monitoring condition will arise through a
source's failure to take the appropriate corrective actions within a
specific time period.

The compliance determination and compliance monitoring requirements for
individual facilities or specific areas of the source are described in
detail in Appendix A of this TSD.

> The draft permit contains provisions related to the Permitee's
> obligation to operate the Continuous Emissions Monitoring Systems
> (CEMS). The most recent federal rules specifically address certain
> situations that that arise outside of Permitee's control. The General
> Provisions of the National Emission Standards for Hazardous Air
> Pollutants addresses this issue at 40 CFR 63.8(c) (4). This provision
> exempts the collection of emissions information during "system
> breakdowns, out-of-control periods, repairs, maintenance periods,
> calibration checks, and zero (low-level) and high-level calibration
> drift adjustments." 40 CFR 63 also requires that the CEMS be included
> in the Startup, Shutdown, and Malfunction Plan for the source to
> ensure that necessary repairs are made as expeditiously as possible.
> The Compliance Assurance Monitoring rule allows downtime at 40 CFR
> 64.7(c) for "monitoring malfunctions, associated repairs, and required
> quality assurance or control activities."
>
> The applicable state rules, 326 IAC 3-5 (Continuos Monitoring of
> Emissions) does not contain such specific exemptions. However, 326 IAC
> 3-5-4(a)(9) requires a preventative maintenance plan to "ensure
> continuous operation and to minimize malfunctions."
>
> 326 IAC 3-5-7(5) requires reports of continuous monitoring system
> downtime. Zero and span checks are reported separately; and reports
> for all other events shall include: the date of the downtime, time of
> commencement, duration of downtime, reasons for each downtime, and the
> nature of system repairs and adjustments.
>
> The state rule requires a plan to minimize, not eliminate
> malfunctions. The IDEM considers the extent and reason for downtime
> when deciding whether to pursue enforcement when small amounts of data
> are not collected due to CEMS malfunction. The draft permit contains
> language at C.10, C.11, D.12.14, D12.15, D12.16, D13.14, D13.15,
> D13.17, D14.4, D14.6, D14.7, D15.5, and D15.6, which require that the
> CEMS be operated at all times except during reasonable, and properly
> documented periods of calibration activities and malfunction. Downtime
> due to malfunction and subsequent repair is not to exceed 3%. The OAQ
> will continue to consider this issue, including public comment on this
> specific permit, prior to making a final decision on this matter.

**Conclusion**

> The operation of this bulk pharmaceutical manufacturing plant and
> associated support facilities shall be subject to the conditions of
> the attached proposed **PSD and Part 70 Permit No. T157‑6879-00006.**