DAQ-2025-002003

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DAQC-CI105170001-25
Site ID 10517 (B1)

MEMORANDUM

TO: FILE – TEVA PHARMACEUTICALS USA – Pharmaceutical Manufacturing
Facility

THROUGH: Chad Gilgen, Minor Source Compliance Section Manager

FROM: Irene Tucker, Environmental Scientist

DATE: March 18, 2025

SUBJECT: FULL COMPLIANCE EVALUATION, Minor, Salt Lake County

INSPECTION DATE: January 5, 2024

SOURCE LOCATION: 575 Chipeta Way, Building 577
Salt Lake City, UT 84108
SOURCE CONTACTS: Tim Rhees CSM, LSP, Senior Director, Operational Safety
Americas, 801-401-7552, (C)-801-867-0097
[e-mail]

Cody Andrew, Senior Manager EHS, (C)-801-336-7529,
[e-mail]

OPERATING STATUS: In operation.

PROCESS DESCRIPTION: Teva Pharmaceutical (TEVA) is a secured pharmaceutical
manufacturer focused on transdermal products and patches,
including nicotine patches, lidocaine patches, and hormone
therapy patches. Coater Dryer Laminators (CDLs) are used in
transdermal patch production. CDLs process vessels of casting
solutions that are pressurized with nitrogen gas. The pressure
moves the casting solution to the metering pumps which
dispense solutions through extruders. Products are packaged
onsite prior to shipment.

TEVA operates three 300,000 Btu/hour Catalytic Thermal
Oxidizers (CTOs) for its processes, and one smaller CTO in its
R&D process. The CTOs have a 97 percent destruction
efficiency (DRE). TEVA also operates two 10.5 MMBtu/hr
boilers, three 9 MMBtu/hr boilers, two 5.86 MMBtu/hr boilers,
and three emergency generators.

/ :
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APPLICABLE REGULATIONS: Approval Order (AO) DAQE-AN105170020-21, dated June 23,
2021
NSPS (Part 60) Dc: Standards of Performance for Small
Industrial-Commercial-Institutional Steam Generating Units,
NSPS (Part 60) Subpart IIII: Standards of Performance for
Stationary Compression Ignition Internal Combustion Engines,
NSPS (Part 60) Subpart JJJJ: Standards of Performance for
Stationary Spark Ignition Internal Combustion Engines,
NSPS (Part 60) Subpart RR: Standards of Performance for
Pressure Sensitive and Label Surface Coating Operations,
MACT (Part 63) Subpart ZZZZ: National Emissions Standards
for Hazardous Air Pollutants for Stationary Reciprocating
Internal Combustion Engines,

SOURCE EVALUATION:

Name of Permittee: Permitted Location:

Teva Pharmaceuticals USA. - Pharmaceutical
Manufacturing Facility

575 Chipeta Way 575 Chipeta Way
Salt Lake City, UT 84108 Salt Lake City, UT 84108

SIC Code: 2834: (Pharmaceutical Preparations)

SECTION I: GENERAL PROVISIONS

I.1 All definitions, terms, abbreviations, and references used in this AO conform to those used in the
UAC R307 and 40 CFR. Unless noted otherwise, references cited in these AO conditions refer to
those rules. [R307-101]

I.2 The limits set forth in this AO shall not be exceeded without prior approval. [R307-401]

I.3 Modifications to the equipment or processes approved by this AO that could affect the emissions
covered by this AO must be reviewed and approved. [R307-401-1]

I.4 All records referenced in this AO or in other applicable rules, which are required to be kept by
the owner/operator, shall be made available to the Director or Director's representative upon
request, and the records shall include the two-year period prior to the date of the request. Unless
otherwise specified in this AO or in other applicable state and federal rules, records shall be kept
for a minimum of two (2) years. [R307-401-8]

I.5 At all times, including periods of startup, shutdown, and malfunction, owners and operators shall,
to the extent practicable, maintain and operate any equipment approved under this AO, including
associated air pollution control equipment, in a manner consistent with good air pollution control
practice for minimizing emissions. Determination of whether acceptable operating and
maintenance procedures are being used will be based on information available to the Director
which may include, but is not limited to, monitoring results, opacity observations, review of
operating and maintenance procedures, and inspection of the source. All maintenance performed
on equipment authorized by this AO shall be recorded. [R307-401-4]

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I.6 The owner/operator shall comply with UAC R307-107. General Requirements: Breakdowns. [R307-107]
I.7 The owner/operator shall comply with UAC R307-150 Series. Emission Inventories. [R307-150] Status: In Compliance. There were no modifications made either to the equipment or processes of this AO. There were no limits exceeded as set forth in this AO. TEVA maintains records for at least two years. TEVA also maintains records of maintenance activities performed on any equipment approved by this AO. The 2022 Emissions Inventory Report indicated compliance with the PTEs of this AO.
SECTION II: PERMITTED EQUIPMENT

II.A THE APPROVED EQUIPMENT

II.A.1 Manufacturing Plant
Salt Lake City Pharmaceutical Manufacturing Plant

II.A.2 575 CHIPETA WAY - MANUFACTURING BUILDING
Includes Items II.A.3 through II.A.11

II.A.3 Two (2) Boilers
Rating: 10.5 MMBtu/hr Each
Fuel: Natural Gas
Control: Low-NOx Burner (30 ppm or less)
NSPS Applicability: Subpart Dc

II.A.4 Two (2) Boilers
Rating: 5.86 MMBtu/hr Each
Fuel: Natural Gas NSPS Applicability: None

II.A.5 One (1) Emergency Generator
Rating: 1,000 kW
Fuel: Diesel
Manufacture Date: 2017
MACT Applicability: Subpart ZZZZ NSPS Applicability: Subpart IIII

II.A.6 One (1) Emergency Generator
Rating: 320 kW
Fuel: Natural Gas
Manufacture Date: 2012
MACT Applicability: Subpart ZZZZ NSPS Applicability: Subpart JJJJ

II.A.7 Various Fume Hoods
Equipment-cleaning rooms with associated fume hoods
Room 1509 and 1910 - Excipient ingredient
Room 1218 - Liquid Reservoir System Equipment
Room 1219 - Matrix equipment
Room 1510 - Lidocaine Equipment
Room 1910 - Dispensing
Room 2117 - Solvent Dispensing
Room 2159 - Mixing
Room 2163 - Mixing
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II.A.8 Three (3) CDLs Coating - Coater-Dryer-Laminator Machines (CDLs) Control: VOC sensors and CTO each 1. Room 1165 Rating: 8.9 feet per hour (8 kg casting solution per hour) 2. Room 1170 Rating: 8.9 feet per hour (8 kg casting solution per hour) 3. Room 1171 Rating: 16 feet per hour (29 kg casting solution per hour) NSPS Applicability: Subpart RR II.A.9 Three (3) Catalytic Thermal Oxidizers (CTOs) Controls: Three (3) CDLs (II.A.8) Fuel: Natural Gas Rating: 300,000 Btu/hr Each II.A.10 One (1) Hydrogel CDL Machine Room 2503 Rating: 10 to 100 feet per minute Includes: Associated Mixers and Three (3) Natural Gas-Fired Burners (rated at 1.3 MMBtu/hr each) for product drying NSPS Applicability: Subpart RR This CDL will process only water-based products; therefore, the only emissions will result from the natural gas combustion in the burners. II.A.11 Waste Water Treatment One (1) Air Stripping Column Capacity: 120 gallons per hour Includes: Two (2) Waste Water Tanks II.A.12 577 CHIPETA WAY -RESEARCH AND DEVELOPMENT BUILDING Includes Items II.A.13 through II.A.18 II.A.13 Three (3) Boilers Rating: 9 MMBtu/hr Each Boiler #1 Control: Low-NOx Burner (less than 30 ppm) Fuel: Natural Gas NSPS Applicability: None II.A.14 One (1) Emergency Generator Rating: 750 kW Fuel: Diesel Installed in 2004 MACT Applicability 40 CFR 63 Subpart: ZZZZ NSPS Applicability: None II.A.15 Two (2) R&D Coating - CDL Machines 1. Room 228 Rating: 8.9 feet per hour (8 kg casting solution per hour) 2. Room 222 Rating: 8.9 feet per hour (8 kg casting solution per hour) NSPS Applicability: Subpart RR II.A.16 One (1) Thermal Oxidizer Controls: R&D CDL (II.A.15) Efficiency: 97%
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II.A.17 Various Fume Hoods Cleaning Areas Room 230 (two (2) fume hoods) Room 238 Room 244 Room 246 Room 287 II.A.18 Various Heaters, Boilers, and Humidifiers Rating: < 5 MMBtu/hr Each Fuel: Natural Gas
Status: In Compliance. There was no new or unapproved equipment observed onsite during
this inspection. The two existing 10.5 MMBtu/hr boilers are equipped with Low-NOx
burners, and are not subject to the new Boiler Rules that took effect on May 1, 2024. The
Combustion Analyses for the boilers were conducted on August 28, 2024, by Mechanical
Service & Systems, Inc. See the attachment for additional information.

SECTION II: SPECIAL PROVISIONS

II.B REQUIREMENTS AND LIMITATIONS
II.B.1 Site-Wide Requirements II.B.1.a The owner/operator shall comply with all applicable requirements in R307-325 and R307-344. [R307-325, R307-401-8] R307-325 Ozone Nonattainment and Maintenance Areas Status: In Compliance. During this inspection, there were no open containers or spills observed onsite. R307-344 Paper, Film, or Foil Coatings Records shall include, but are not limited to, inventory and product data sheets of all coatings and solvents subject to R307-344.
Status: In compliance. The Catalytic Thermal Oxidizers (CTOs) are serviced by the Coating Dryer Laminator (CDL) equipped with VOC sensors to shut off if the CTO is not operating. The CTOs are part of the coded recipe for products containing VOC-emitting chemicals. The CTOs are attached to three CDLs solvent-based mixtures; the 1165 CDL, the 1170 CDL, and the 1171 CDL. The CDL will not start until the CTO has reached the required operating temperature. The CDLs apply the Active Pharmaceutical Ingredient (API)-based coating on the patches. The CDLs producing water-based products do not require the CTO to be in operation. Teva Pharmaceuticals maintains a 12-month record of the amount of solvent applied in the coatings. The VOCs in the solvent include ethyl acetate and vinyl acetate, and the emissions are routed through the CTO which has a 97% DRE. See the lbs/lbs record in the email attachment.
According to the NOI document, VOC and HAP emission factors for CDL machines assume a 97% emission reduction from the Catalytic Oxidizer Control Systems. See the attachment for additional information.
According to TEVA, the operating temperature of the CTOs is greater than 600 degrees Fahrenheit, and the CDL is programmed to not be able to start until the CTOs reach 600 degrees Fahrenheit. If the CTO temperature drops below 600 degrees Fahrenheit, the CDL shuts down.
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To ensure that the CTOs operate as designed to meet the desired DRE of 97%, TEVA conducts an Annual Burner Safety Evaluation of CTOs, an Annual Operation Inspection Evaluation of CDL4 Zone 1, and Zone 3, and also conducts a Semi-Annual PM Efficiency Readings to determine the burn efficiency rate of the Catox. If the burn efficiency drops below 75.5%, the Catox is taken out of service and a new catalyst is installed. See the attachment for additional information.
II.B.1.b The owner/operator shall not allow visible emissions from any point or fugitive emission source subject to this AO to exceed 10% opacity. [R307-401-8] II.B.1.b.1 Opacity observations of emissions from stationary sources shall be conducted in accordance with 40 CFR 60, Appendix A, Method 9. Visible emissions from intermittent sources shall use procedures similar to Method 9, but the requirement for observations to be made at 15-second intervals over a six-minute period shall not apply. Any time interval with no visible emissions shall not be included. [R307-305-3] Status: In Compliance. There were no visible emissions observed from any point or fugitive emission source during this inspection. The opacity observations were conducted in accordance with 40 CFR 60, Appendix A, Method 9. II.B.1.c The owner/operator shall install and maintain sensors to shut off each CDL on all CDLs in the manufacturing plant at 575 Chipeta Way. The sensors shall shut off the CDL if the Catalytic Thermal Oxidizer is not operating. [R307-401-8] Status: In Compliance. TEVA has installed and maintained sensors to shut off each CDL if the Catalytic Thermal Oxidizer is not operating. According to TEVA, “The Catalytic Thermal Oxidizers (CTOs) are serviced by Coating Dryer Laminator (CDL) equipped with VOC sensors to shut off if the CTO is not operating. The CTOs are part of the coded recipe for products containing VOC-emitting chemicals. The CDL will not start operation until the oxidizer has reached operating temperature. The oxidizer is initially heated using natural gas and when at operating temperature will allow the CDL to start processing solvent-based materials. If the oxidizer faults / stops running the CDL coded logic shuts down the CDL and will not allow it to restart until the oxidizer is back fully operational and has reached the correct operating temperature.” “The solvent-based matrix patch production on the CDLs are controlled by the CTOs and operate continuously during solvent-based matrix patch production. The CDL will not run if the CTO is not in operation. The recipe is coded to shut down the CDL if the CTO faults or fails. See above.”
If a CDL is producing water-based products, the CTO that services that specific CDL need not operate during that period of water-based production. “The CDLs producing water-based products operating with the CTO that services the specific CDL for aqueous based products that run on the CDLs the CTO is not used. The software coded recipe for each aqueous product/operation does not command the CTO to be operational like when processing solvent based products.”

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II.B.2 VOC & HAP REQUIREMENTS

II.B.2.a The owner/operator shall not emit more than the following from evaporative sources
(painting, printing, coating, and/or cleaning) on site:

15.9 tons per rolling 12-month period of VOCs
0.07 tons per rolling 12-month period of all HAPs combined.
[R307-401-8]

Status: In Compliance. The Rolling 12-month VOC and HAP emissions from
December 2022 to November 2023, indicated the following:

4.029 tons per rolling 12-month period of VOCs
0.323 tons per rolling 12-month period of all HAPs combined.

See the attachment for additional information.

II.B.2.a.1 The owner/operator shall calculate a new 12-month total by the 20th day of each month
using data from the previous 12 months. The owner/operator shall use a mass-balance
method to calculate emissions from evaporative sources. The owner/operator may use
the following equations with applicable units to comply with the mass-balance method:

VOCs = [% VOCs by Weight/100] x [Density] x [Volume Consumed]

HAP = [% HAP by Weight/100] x [Density] x [Volume Consumed]

For printing processes, a 20% control may be assumed for inks used in printing
processes.

[R307-401-8]

II.B.2.a.2 The owner/operator shall use a mass-balance method to quantify any amount of VOCs
and HAPs reclaimed. The owner/operator shall subtract the amount of VOCs and HAPs
reclaimed from the quantities calculated above to provide the monthly total emissions of
VOCs and HAPs. [R307-401-8]

II.B.2.a.3 The owner/operator shall keep records each month of the following:

A. The name (as per SDS) of the VOC- and HAP-emitting material

B. The maximum percent by weight of VOCs and each HAP in each material used

C. The density of each material used

D. The volume of each VOC- and HAP-emitting material used

E. The amount of VOCs and the amount of each HAP emitted from each material

F. The amount of VOCs and the amount of each HAP reclaimed and/or controlled
from each material

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G. The total amount of VOCs, the total amount of each HAP, and the total amount
of all HAPs combined emitted from all materials (in tons)

[R307-401-8]

Status: In Compliance. TEVA uses a mass-balance method to calculate
emissions from evaporative sources and keeps records of VOCs and HAPs as
required by this AO Condition.

II.B.2.b The owner/operator shall use the Thermal Oxidizer to capture and contain the emissions
from the R&D CDL. [R307-401-8]

Status: In Compliance. TEVA uses the Thermal Oxidizer which has a 97%
destruction efficiency to capture and contain emissions from the R&D CDL.

II.B.2.c The owner/operator shall control emissions from each CDL with a Catalytic Thermal
Oxidizer at all times except times when a CDL is producing water-based products.
During water-based production, the CDL may operate without a catalytic thermal
oxidizer. [R307-401-8]

Status: In Compliance. TEVA controls emissions from each CDL with a Catalytic
Thermal Oxidizer which has a 97% destruction efficiency at all times, except times
when a CDL is producing water-based products, and does not require a catalytic
thermal oxidizer.

II.B.2.c.1 The owner/operator may use the following equations to determine emission totals after
control.

VOCs = [VOCs determined by mass-balance method] x [1 - 97%]
HAP = [HAP determined by mass-balance method] x [1 - 97%].
[R307-401-8]

Status: In Compliance. The emissions are calculated using the formulas provided.
II.B.3 EMERGENCY ENGINE REQUIREMENTS

II.B.3.a The owner/operator shall not operate each emergency engine on site for more than 100
hours per rolling 12-month period during non-emergency situations. There is no time
limit on the use of the engines during emergencies. [R307-401-8, 40 CFR 63 Subpart
ZZZZ]
Status: In Compliance. TEVA operates three emergency generators, and none of the operations exceeded 100 hours in a rolling 12-month period. The emergency generators run for maintenance purposes monthly for about 15 minutes. The Onan 1,000 KW diesel-fueled emergency generator was manufactured in 2017. The hours of operation in a rolling 12-month period from December 2022 to November 2023, indicated 2.78 hours. The Caterpillar 750 KW diesel-fueled emergency generator was manufactured in 2004. The hours of operation in a rolling 12-month period from December 2022 to November 2023, indicated 2.8 hours. The Kohler Spark-Ignition, 320 KW emergency generator was manufactured in 2012, and is configured only for natural gas use. The hours of operation in a rolling 12-month period from December 2022 to November 2023, indicated 2.96 hours. See the logs in the attachment.

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II.B.3.b The owner/operator shall conduct engine maintenance and testing within the following
parameters:

A. Each engine shall be tested between the hours of 8:00 AM and 4:00 PM

B. Only one (1) engine shall be operated for maintenance and testing at a time

C. Each engine shall not exceed 20 minutes of operation per maintenance and
testing per hour.
[R307-401-8]

II.B.3.b.1 To determine compliance with a rolling 12-month total, the owner/operator shall
calculate a new 12-month total by the 20th day of each month using data from the
previous 12 months. Records documenting the operation of each emergency engine shall
be kept in a log and shall include the following:

A. The date and time the emergency engine was used

B. The duration of operation in minutes

C. The reason for the emergency engine usage.
[40 CFR 60 Subpart ZZZZ, R307-401-8]

Status: In Compliance. The emergency generators run monthly for about 15
minutes for maintenance purposes between the hours of 8:00 AM and 4:00 PM.
Only one emergency generator is operated for maintenance and testing at a time.

II.B.3.b.2 To determine the duration of operation, the owner/operator shall install a non-resettable
hour meter for each emergency engine. [R307-401-8, 40 CFR 63 Subpart ZZZZ]

Status: In Compliance. All the emergency generators are each equipped with a
non-resettable hour meter.

II.B.3.c The owner/operator shall only use diesel fuel (e.g. fuel oil #1, #2, or diesel fuel oil
additives) as fuel in engines listed under II.A.5 and II.A.14. The owner/operator shall
only use natural gas as fuel in the engine listed under II.A.6. [R307-401-8]

Status: In Compliance. TEVA uses diesel as fuel in engines listed under II.A.5 and
II.A.14, and natural gas as fuel in the engine listed under II.A.6.

II.B.3.c.1 The owner/operator shall only combust diesel fuel that meets the definition of ultra-low
sulfur diesel (ULSD), which has a sulfur content of 15 ppm or less. [R307-401-8]

II.B.3.c.2 To demonstrate compliance with the ULSD fuel requirement, the owner/operator shall
maintain records of diesel fuel purchase invoices or obtain certification of sulfur content
from the diesel fuel supplier. The diesel fuel purchase invoices shall indicate that the
diesel fuel meets the ULSD requirements. [R307-401-8]

Status: In Compliance. The Fuel Certification from Silver Eagle Refining indicated
that the sulfur content was characterized as Ultra Low Sulfur Diesel (ULSD), and as
6.195 parts per million (ppm). See the attachment for additional information.
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Section III: APPLICABLE FEDERAL REQUIREMENTS

In addition to the requirements of this AO, all applicable provisions of the following federal programs
have been found to apply to this installation. This AO in no way releases the owner or operator from any
liability for compliance with all other applicable federal, state, and local regulations including UAC
R307.

NSPS (Part 60) Dc: Standards of Performance for Small Industrial-Commercial-Institutional Steam Generating
Units

Status: In Compliance. TEVA operates two 10.5 MMBtu/hr natural gas boilers.
NSPS (Part 60) IIII: Standards of Performance for Stationary Compression Ignition Internal Combustion
Engines

Status: In Compliance. The Onan 1,000 KW diesel-fueled emergency generator was manufactured in
2017, and it is equipped with a non-resettable hour meter. According to the Fuel Certification Report
from Silver Eagle Refining, the sulfur content of the diesel indicated 6.195 parts per million (ppm). See
the Fuel Certification Report and the maintenance records in the attachment.
NSPS (Part 60) JJJJ : Standards of Performance for Stationary Spark Ignition Internal Combustion Engines

Status: In Compliance. The Kohler Spark-Ignition, 320 KW emergency generator was manufactured in
2012, and is configured only for natural gas use. It is equipped with a non-resettable hour meter. See the
maintenance records in the attachment.
NSPS (Part 60) RR: Standards of Performance for Pressure Sensitive and Label Surface Coating Operations

Status: In Compliance. From January to December 2022, TEVA fed 16.1 tons of VOCs to the CDL
lines, also meeting the 60.440(b) requirement. TEVA maintains records electronically for at least two
years, and also maintains a calendar month record of all coatings used according to 60.445(a)
requirement. According to TEVA, the coating process is a closed system in which; “the CDL equipment
captures 100% of the solvent vapor.” The solvent destruction temperatures are greater than 600 degrees
Fahrenheit, and are monitored throughout the production process. TEVA has installed and maintained
sensors designed to shut off each CDL if the Catalytic Thermal Oxidizer is not operating. The
temperature sensors are calibrated and the temperature is monitored throughout the process. See the
attachment for additional information.

MACT (Part 63) - ZZZZ: National Emissions Standards for Hazardous Air Pollutants for Stationary
Reciprocating Internal Combustion Engines

Status: In Compliance. The Caterpillar 750 KW diesel-fueled emergency generator was manufactured
in 2004, and it is equipped with a non-resettable hour meter. According to the Fuel Certification Report
from Silver Eagle Refining, the sulfur content of the diesel indicated 6.195 ppm. See the Fuel
Certification Report and the maintenance records in the attachment.

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AREA SOURCE RULES EVALUATION:

The following Area Source Rules were evaluated during this inspection:

R307-203 Emission Standards: Sulfur Content of Fuels

Status: In Compliance. According to the Fuel Certification Report from Silver Eagle Refining, the
sulfur content of the diesel is 6.195 ppm. See the Fuel Certification Report in the attachment.

R307-304 – Solvent Cleaning

Status: Exemption R307-304-3(1). TEVA is claiming this exemption which states that “The
requirements of R307-304 do not apply to the operations that are subject to R307-342 through
R307-347 and R307-349 through R307-355.”

R307-210 - Standards of Performance for New Stationary Sources

Status: In Compliance. This area source rule is applicable to 40 CFR Part 60, Subparts Dc, IIII, and
JJJJ. See Section III for compliance with this requirement.

R307-214 - National Emission Standards for Hazardous Air Pollutants

Status: In Compliance. This area source rule is applicable to 40 CFR Part 63, Subpart ZZZZ. See
Section III for compliance with this requirement.

R307-325 Ozone Nonattainment and Maintenance Areas

Status: In Compliance. During this inspection, there were no open containers or spills observed
onsite.

R307-344. Paper, Film, and Foil Coatings

Records shall include, but are not limited to, inventory and product data sheets of all coatings and solvents
subject to R307-344.

Status: In compliance. The Catalytic Thermal Oxidizers (CTOs) are serviced by the Coating Dryer
Laminator (CDL) equipped with VOC sensors to shut off if the CTO is not operating. The CTOs are
part of the coded recipe for products containing VOC-emitting chemicals. The CTOs are attached to
three CDLs solvent-based mixtures; the 1165 CDL, the 1170 CDL, and the 1171 CDL. The CDL will
not start until the CTO has reached the required operating temperature. The CDLs apply the Active
Pharmaceutical Ingredient (API)-based coating on the patches. The CDLs producing water-based
products do not require the CTO to be in operation. Teva Pharmaceuticals maintains a 12-month
record of the amount of solvent applied in the coatings. The VOCs in the solvent include ethyl acetate
and vinyl acetate, and the emissions are routed through the CTO which has a 97% DRE. See the
lbs/lbs record in the email attachment.

According to the NOI document, VOC and HAP emission factors for CDL machines assume a 97%
emission reduction from the Catalytic Oxidizer Control Systems. See the attachment for additional
information.

According to TEVA, the operating temperature of the CTOs is greater than 600 degrees Fahrenheit,
and the CDL is programmed to not be able to start until the CTOs reach 600 degrees Fahrenheit. If
the CTO temperature drops below 600 degrees Fahrenheit, the CDL shuts down.

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To ensure that the CTOs operate as designed to meet the desired DRE of 97%, TEVA conducts an Annual Burner Safety Evaluation of CTOs, an Annual Operation Inspection Evaluation of CDL4 Zone 1, and Zone 3, and also conducts a semi-Annual PM Efficiency Readings to determine the burn efficiency rate of the Catox. If the burn efficiency drops below 75.5%, the Catox is taken out of service and a new catalyst is installed. See the attachment for additional information.

EMISSION INVENTORY: Status. In Compliance. The 2022 Emissions Inventory Report indicated compliance with the PTEs of this AO.

Listed below are the Actual Emissions Inventory provided from Teva Pharmaceuticals USA. -
Pharmaceutical Manufacturing Facility. A comparison of the estimated total potential emissions (PTE) on
AO: DAQE-AN105170020-21, dated June 23, 2021, is provided.
PTE are supplied for supplemental purposes only.

Criteria Pollutant PTE tons/yr Actuals tons/yr
2022 E.I.
CO2 Equivalent 15962.00 ---
Carbon Monoxide 26.77 13.07
Nitrogen Oxides 25.65 12.33
Particulate Matter - PM10 2.45 1.19
Particulate Matter - PM2.5 2.45 1.19
Sulfur Oxides 0.19 0.09
Volatile Organic Compounds 17.39 4.36

Hazardous Air Pollutant PTE lbs/yr Actuals lbs/yr
Generic HAPs (CAS #GHAPS) 1320 ---

PREVIOUS ENFORCEMENT
ACTIONS: No enforcement actions within the past five years.

COMPLIANCE STATUS &
RECOMMENDATIONS: TEVA is in compliance with the conditions in the Approval
Order (AO) DAQE-AN105170020-21, dated June 23, 2021.
TEVA maintained good housekeeping practices.

HPV STATUS: Not Applicable.

RECOMMENDATION FOR
NEXT INSPECTION: Inspect as usual. Required PPE includes steel-toe boots, safety
glasses, smock, hair net, shoe covers.

NSR RECOMMENDATION: None at this time.

ATTACHMENTS: Applicable Supporting Documentation Included