DAQ-2024-004616

1
DAQC-CI109510001-23
Site ID 10951 (B1)
MEMORANDUM

TO: FILE – FRESENIUS MEDICAL CARE – Ogden Dialysis Products Manufacturing

THROUGH: Chad Gilgen, Minor Source Compliance Section Manager

FROM: Daniel Riddle, Environmental Scientist

DATE: November 20, 2023

SUBJECT: FULL COMPLIANCE EVALUATION, Minor, Weber County

INSPECTION DATE: November 1, 2023

SOURCE LOCATION: 475 West 13th Street
Ogden, UT 84404
SOURCE CONTACTS: Jennifer Johnson, EHS Manager
385-626-2397 [e-mail]
Justin Ipsen, Director of Facilities Operations
385-626-2397 [e-mail]

OPERATING STATUS: Operating normally at the time of inspection.

PROCESS DESCRIPTION: Fresenius Medical Care operates a pharmaceutical
manufacturing plant that prepares peritoneal and hemodialysis
products in Ogden, Utah. Products are pharmaceutical solutions
and disposable devices that are used by persons suffering from
kidney disease. Hemodialysis filters serve as an artificial kidney
and are used to clean impurities in the blood stream.
Hemodialysis dialyzers are produced in three steps: hollow fibers
production, plastic injection molding of housing (case and caps
components), and assembly of fibers and components into
finished filters.

Hollow fiber components production begins in the compounding
room where dimethylacetamide (DMAC) solvent is pumped into
a heated tank with two pre-polymers, polyvinylpyrrolidone
(PVP) and polysulfone. The resulting mixture is pumped into a
60°C (140°F) holding tank. A fiber producing machine is used to
spin the fibers from a precipitant material injected into the
DMAC solution. In the spinner, fibers are produced in small
spinnerets where the polymer and precipitant are extruded
through a circular space. The resultant hollow fibers are
solidified when contacted with water. The fibers are pulled
through several water wash tanks to remove DMAC, and then
are pulled through several drying devices. The normal set
temperatures for the drying sections are 80°C - 130°C (176°F -
266°F) in different cross sections. Dried extruded fibers are
coiled on spools to bundle thickness and cut to length.

2
The discharge water is laden with approximately 2% DMAC.
The discharge water is routed through a distillation complex that
recovers both water and DMAC. The fiber line air, containing
less than 40 ppm DMAC, from the drying sections and above the
water bath is exhausted to one of five dual column packed bed
fume scrubbers or one single column packed bed fume scrubber.

Case Manufacture: Plastic chips are stored in silos and are used
in the injection molding process. The plastic chips are
pneumatically loaded into the mold machine to make
components of the dialyzer casing.

The cut fibers are secured in the dialyzer body by temporary end
caps. Polyurethane resin, a pre-polymer Vorite, and the poly
Polycin, are pumped through a mixing head and injected into the
plastic ends of the rotating filter. The temporary end pieces are
cut away allowing the open ends of the fibers in the tube to be
exposed. The end caps are installed and the product is sealed,
tested, packaged, and sterilized. The entire process is done in a
sterile environment.

The peritoneal products consist of large bags that are produced
with various tubes and valves that are filled with sterile aqueous
solutions containing a variety of pharmaceutical products. The
sterile bags are made by melting plastic tube material in rolls to
varying lengths. Various fittings, tubes, and valves are also
affixed to the bags by melting them onto the bag. The bags are
then filled with the sterile solution that is stored in large stainless
steel vats. The product is packaged and for use in the peritoneal
dialysis.

Emergency generator engines are used to ensure that the
electricity at the source is not interrupted. The generators operate
on diesel fuel and natural gas. The source boilers are used to heat
water and for building heat, operate on natural gas as a primary
fuel and diesel fuel as a back-up fuel during natural gas
curtailment. The boilers use low sulfur fuel oil and are equipped
with low-NOx burners to control emissions.

APPLICABLE REGULATIONS: Approval Order (AO) DAQE-AN109510024-23, dated August
15, 2023
NSPS (Part 60) Dc : Standards of Performance for Small
Industrial-Commercial-Institutional Steam Generating Units,
NSPS (Part 60) IIII : Standards of Performance for Stationary
Compression Ignition Internal Combustion Engines,
NSPS (Part 60) JJJJ : Standards of Performance for Stationary
Spark Ignition Internal Combustion Engines,
MACT (Part 63) JJJJJJ : National Emission Standards for
Hazardous Air Pollutants for Industrial, Commercial, and
Institutional Boilers Area Sources,

3
SOURCE EVALUATION:

Name of Permittee: Permitted Location:

Fresenius Medical Care - Ogden Dialysis Products
Manufacturing

475 W 13th St 475 West 13th Street
Ogden, UT 84404 Ogden, UT 84404

SIC Code: 3842: (Orthopedic, Prosthetic, & Surgical Appliances & Supplies)

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]

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. No limits set forth in this AO appear to have been exceeded. The
source stated that there have been no modifications to the equipment or processes. The
equipment appeared to be properly operated and maintained according to manufacturer
recommendations. Records are kept as required and were made available after the
inspection. No breakdowns have been reported since the previous inspection.

I.8 The owner/operator shall submit documentation of the status of construction or modification to
the Director within 18 months from the date of this AO. This AO may become invalid if
construction is not commenced within 18 months from the date of this AO or if construction is
discontinued for 18 months or more. To ensure proper credit when notifying the Director, send
the documentation to the Director, attn.: NSR Section. [R307-401-18]

Status: In Compliance. Notification of new equipment installation was submitted following
the inspection. See the attachment below.

4
Section II: SPECIAL PROVISIONS

II.A The approved installations shall consist of the following equipment:

II.A.1 Ogden Dialysis Products Manufacturer
Medical device manufacturer

II.A.2 Boiler #1
200 HP (8.4 MMBtu/hr) boiler

II.A.3 Boiler #2
200 HP (8.4 MMBtu/hr) boiler

II.A.4 Boiler #3
400 HP (16.7 MMBtu/hr) boiler,
dual-fuel

II.A.5 Boiler #6
400 HP (16.3 MMBtu/hr) boiler, dual-fuel

II.A.6 Boiler #7
500 HP (16.7 MMBtu/hr) boiler, dual-fuel

II.A.7 Boiler #8
500 HP (16.7 MMBtu/hr) boiler, dual-fuel

II.A.8 Boiler #9
500 HP (16.7 MMBtu/hr) boiler, dual-fuel

II.A.9 Boiler #10
500 HP (20.9 MMBtu/hr) boiler

II.A.10 Boiler #11
500 HP (16.2 MMBtu/hr) boiler

II.A.11 Boiler #14
400 HP (16.39 MMBtu/hr), dual-fuel
Retrofit with an ultra-low NOx burner (NOx emission concentration is at 9 ppm or less) - new
equipment

II.A.12 Boiler #15
500 HP (16.8 MMBtu/hr), dual-fuel

II.A.13 Boiler #16
One (1) boiler rated at 500 HP (20.41 MMBtu/hr)
Primary Fuel: natural gas
Secondary Fuel: fuel oil #2
Manufactured in 2015

II.A.14 Boiler #17
500 HP (20.41 MMBtu/hr), natural gas-fired
Manufactured in 2016

II.A.15 Boiler #18
500 HP (20.41 MMBtu/hr), natural gas-fired
Manufactured in 2016

5
II.A.16 Drum Dryers
Two (2) Drum Dryers (steam)

II.A.17 Drum Dryer #3
One drum dryer rated at 0.715 MMBtu/hr
Controlled by Scrubber Tower #2

II.A.18 Emergency Generator Engines #1 and 2
Two (2) 750 kW (1006 HP) (each) emergency generator engines - diesel-fired
Manufactured in 1998

II.A.19 Emergency Generator Engines #3, 4, 5, and 7
Four (4) 800 kW (1073 HP) (each) emergency generator engines - diesel-fired
One (1) manufactured in 2003, two (2) in 2001, and (1) in 2006.

II.A.20 Emergency Generator Engine #6
One (1) 110 kW (148 HP) emergency generator engine - diesel-fired
Manufactured in 2006

II.A.21 Emergency Generator Engine #8
One (1) 800 kW (1073 HP) emergency generator engine - diesel-fired
Manufactured in 2008

II.A.22 Generator Engine #9
One (1) diesel-fired emergency generator engine rated at 1,000 kW (1,341 HP)
Manufactured in 2014

II.A.23 Emergency Generator Engine #10
One (1) natural gas-fired emergency generator rated at 122 HP

II.A.24 Emergency Generator Engines #11, 12, 13, and 14
Four (4) 905 kW (1214 HP) (each) emergency generator engines - diesel-fired
All manufactured in 2017

II.A.25 Fire Pump Engines
Fire pump engine #1, rated at 200 HP and diesel-fired
Fire pump engine #2, rated at 350 HP and diesel-fired

II.A.26 Electron Beam Sterilization System
Ozone Control

II.A.27 Fiber Spinning/Production Lines
Ten (10) Fiber Spinning Lines (Line 1 through 10)

II.A.28 Fiber Spinning/Production Lines
Two (2) production to fiber lines #11 and 12

II.A.29 Scrubber #1
Dual tower packed bed scrubber

II.A.30 Scrubber #2
Dual tower packed bed scrubber

II.A.31 Scrubber #3
Dual tower packed bed scrubber

II.A.32 Scrubber #4
Single tower packed bed scrubber

6
II.A.33 Project 1014 (including Scrubber #5)
Equipment includes pumps, reactor, feed system, condensers, heat exchangers, vacuum/scrubber
system, filtration devices, and eight tanks sized from 60 to 5,000 gallons

II.A.34 Scrubber #6
One (1) dual-tower packed-bed scrubber with single exhaust

II.A.35 CE-1 Feed Tank
880 gallon tank - 70% DMAC

II.A.36 CE-2 Feed Tank
880 gallon tank - 70% DMAC

II.A.37 CE-3 Feed Tank
One (1) feed tank with a capacity of 3,000 gallons

II.A.38 DMAC Column Feed Tank
3,000 gallon tank - 70% DMAC

II.A.39 Northwest Feed Tank #1
20,000 gallon tank - 2.5% DMAC

II.A.40 South Feed Tank #2
20,000 gallon tank - 2.5% DMAC

II.A.41 North Feed Tank #3
20,000 gallon tank - 2.5% DMAC

II.A.42 Northeast Feed Tank #4
20,000 gallon tank - 2.5% DMAC

II.A.43 Fresh DMAC Tank
8,000 gallon tank - 100% DMAC

II.A.44 DDFT #1
Drum Dryer Feed Tank
900 gallon tank - 30% DMAC

II.A.45 DDFT #2
One (1) drum dryer feed tank with a capacity of 750 gallons

II.A.46 Rect. DMAC Transfer Tank #1
3,000 gallon tank - 100% DMAC

II.A.47 Rect DMAC Transfer Tank #2
5,000 gallon tank - 100% DMAC

II.A.48 DMAC Recirculation Tank #2
10,000 gallon tank - 100% DMAC

II.A.49 DMAC Recirculation Tank #3
12,000 gallon tank - 100% DMAC

II.A.50 DMAC Recirculation Tank #4
20,000gallon tank - 100% DMAC

II.A.51 Rinse Tank #2
8,000 gallon tank - 100% DMAC; nitrogen blanketed

7
II.A.52 Rinse Tank #3
8,000 gallon tank - 70% DMAC; nitrogen blanketed

II.A.53 Double Effect (DE) Feed Tank #1
8,000 gallon tank - 30% DMAC

II.A.54 Double Effect (DE) Feed Tank #2
One (1) double effect feed tank II with a capacity of 8,000 gallons

II.A.55 Thick Drum Feed Tank
700 gallon tank - 80% DMAC

II.A.56 MVR ME Feed Tank
8,000 gallon tank - 9% DMAC

II.A.57 Fire Pump Tank #1
275 gallon tank - diesel fuel

II.A.58 Fire Pump Tank #2
275 gallon tank - diesel fuel

II.A.59 #2 Fuel Oil Tank
6,000 gallon tank; to supply fuel to Boilers #14, 15 and 16

II.A.60 Generator Tank for Gen 1-6
500 gallon tank - diesel fuel

II.A.61 Generator Tank #7
250 gallon tank - diesel fuel

II.A.62 Generator Tank #8
900 gallon tank - diesel fuel

II.A.63 Waste System Vapor Recovery Tank
160 gallon tank - 90% DMAC

II.A.64 Guard Cart and Power Washer
250 gallon tank - diesel fuel

II.A.65 Precip Fluid Mix Tanks 1-11
Total 11 tanks, each with a capacity of 160 gallons - 50% DMAC

II.A.66 Precip Fluid Supply Tanks 1-11
Total 11 tanks, each with a capacity of 100 gallons - 50% DMAC

II.A.67 Fuel Oil Storage Tank
One (1) 8,000 gallon tank - #2 fuel oil

II.A.68 Polyol Storage Tank
One (1) 1,500 gallon tank

II.A.69 Polyol Storage Tanks
Four (4) 3,326 gallon (each) tanks

II.A.70 Polyol Storage Tank
One (1) 9,100 gallon tank

II.A.71 Polyol Storage Tank
One (1) 9,200 gallon tank

8
II.A.72 Polyol Storage Tanks
Two (2) 10,100 gallon (each) tanks

II.A.73 Polydiisocyanate Storage Tank
One (1) 1,500 gallon tank

II.A.74 Polydiisocyanate Storage Tanks
Four (4) 3,326 gallon (each) tanks

II.A.75 Polydiisocyanate Storage Tank
One (1) 9,200 gallon tank

II.A.76 Polydiisocyanate Storage Tanks
Two (2) 10,100 gallon (each) tanks

II.A.77 Isocyanate Storage Tank
One (1) 9,100 gallon tank

II.A.78 Storage Tanks
Four (4) polyol and isocyanate storage tanks, with a capacity of 9,000 gallons each

II.A.79 Polymer Storage Tank
5,000 gallon tank - 100% DMAC

II.A.80 Solvent Recovery Tank
100 gallon tank - 75% DMAC/Potassium Salt

II.A.81 Reactor B Collection Tank
100 gallon tank - 100% DMAC

II.A.82 NPD Building Hoods
One (1) 4' hood and two (2) 6' hoods

II.A.83 Saline Lab/Quality Lab Hoods
Two (2) 4' hoods, one located at first floor, the other at second floor

II.A.84 Dialyzer R&D Hemodialysis Lab Hood
One (1) 4' hood

II.A.85 Dialyzer Maintenance Shop Hood
One (1) ceiling hood

II.A.86 Molding Maintenance Shop (C-8) Hood
One (1) 4' hood

II.A.87 Spin Block Maintenance Hoods
One (1) 10' and one (1) 6' hoods

II.A.88 Compliant Lab Hood
One (1) 4' hood

II.A.89 Polymer/Analytical Lab Hood
One (1) 12' hood

II.A.90 R&D Lab 2 Hood
One (1) 4' hood

II.A.91 Rectification Lab Hood
One (1) 4' hood

9
II.A.92 Fiber Lab Hood
One (1) 4' hood

II.A.93 Dialyzer Lab Hoods
Two (2), 4' and 12' hoods, located at first floor;
Two (2) 12' hoods located at second floor

II.A.94 Activated Carbon Drum
One (1) activated carbon drum that will control air streams from the two flammable cabinets
connected in series
Located at polyurethane room

II.A.95 Spin Mass and Supply Tanks
Eleven (11) spin mass mixes and eleven (11) supply tanks. The tanks have 1,600 gallon capacity
each

II.A.96 Assembly Lines
Seven (7) dialyzer assembly lines - no emissions; for information only

Status: In Compliance. All boilers and engines were observed at the time of inspection. No
unapproved equipment was observed at any time during the inspection.

II.B Requirements and Limitations

II.B.1 Medical Device Manufacturing Plant.

II.B.1.a The owner/operator shall not allow visible emissions from the following emission points to
exceed the following values:

A. Combustion equipment when fuel oil is burned - 20% opacity
B. Combustion equipment when only natural gas is burned - 10% opacity
C. Any other emission points - no visible emissions. [R307-401-8]

II.B.1.a.1 Opacity observations of emission from stationary sources shall be conducted in accordance with
40 CFR 60, Appendix A, Method 9. [R307-401-8]

Status: In Compliance. No visible emissions were observed from any point at the time of
inspection. Method 9 was utilized to verify opacity limits. See attached VEO form.

II.B.1.b The owner/operator shall not consume more than 17.10 tons of isopropyl alcohol per rolling 12-
month period. [R307-401-8]

II.B.1.b.1 To comply with a rolling 12-month total, the owner/operator shall

A. Determine the isopropyl alcohol consumption by examination of the product purchase
records

B. Keep the records on a monthly basis

C. Calculate a new 12-month total using data from the previous 12 months no later than 20
days after the end of each month

D. Keep the records of consumption for all periods when the plant is in operation.
[R307-401-8]

Status: In Compliance. For the rolling 12-month period from October 2022, through
September 2023, a total of 4.88 tons of isopropyl alcohol were consumed. See the
attachment below.

10
II.B.1.c The owner/operator shall not allow the plant-wide emissions of VOCs and HAPs from
evaporative sources (excluding the products of incomplete combustion from boilers or internal
combustion engines) on site to exceed:

34.21 tons per rolling 12-month period for VOCs
1.00 tons per rolling 12-month period from methylene chloride
0.93 tons per rolling 12-month period from all the following HAPs combined including
acetaldehyde, acetonitrile, benzene, chloroform, p-cresol, 1,4-dichlorobenzene, formaldehyde,
hydrazine, hydrochloric acid, methanol, and toluene. [R307-401-8]

II.B.1.c.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]

[R307-401-8]

II.B.1.c.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.1.c.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

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. For the rolling 12-month period from October 2022, through
September 2023, emissions are as follows:

3.6625 tons for VOCs
0.1410 tons for methylene chloride
0.546 tons for HAPS combined

See the attachments below for more information.

11
II.B.2 Requirements on VOC Control Equipment.

II.B.2.a The owner/operator shall use Scrubber #5 listed in II.A.32 to control process streams from
Project 1014. All exhaust air from Project 1014 shall be routed through this wet scrubber before
being vented to the atmosphere. [R307-401-8]

Status: In Compliance. Scrubber #5 was observed to control process streams from Project
1014.

II.B.2.b The owner/operator shall maintain the operating parameters for the wet scrubber (Scrubber #5)
within the following ranges below:

1. The cooling water flow rate shall not be less than 5 gallons per minute (gpm).

2. The pressure drop between the top and bottom scrubber column shall be less than 2.5 inches of
water column. [R307-401-8]

II.B.2.b.1 The readings shall be accurate to within the following ranges:

1. Pressure drop - plus or minus 1.0 inch of water column

2. Liquid flow rate - plus or minus 2 gpm of the indicated water flow rates. [R307-401-8]

II.B.2.b.2 The parameters shall be monitored with instruments located such that an inspector/operator can
safely read the output any time. All instruments shall be calibrated according to the
manufacturer's instructions at least once every 12 months. Recording of the reading is required
on a once per operational day basis. [R307-401-8]

Status: In Compliance. At the time of inspection, the cooling water flow rate was observed
to be 13 gpm, and the pressure drop was observed to be 1.26 inches of water column.
Readings are monitored at all times. Calibration of this gauge was completed on May 31,
2023.

II.B.2.c The owner/operator shall use Scrubber Towers 1 & 2 to control process streams from the four (4)
fiber spinning lines (lines 1, 2, 3, & 4). These wet scrubbers shall be sized to handle at least
5,000 scfm for the existing conditions. All exhaust air from these fiber spinning lines shall be
routed through its dedicated wet scrubber before being vented to the atmosphere. [R307-401-8]

Status: In Compliance. Scrubber Towers 1 and 2 were observed to control the process
streams from the four fiber spinning lines 1, 2, 3, and 4.

II.B.2.d The owner/operator shall maintain the following operating parameters for Scrubber Towers 1 &
2 within the indicated ranges below:

1. The pressure drop shall be less than 2.5 inches of water column

2. The liquid flow rate shall not be less than 30 gpm. [R307-401-8]

II.B.2.d.1 The readings shall be accurate to within the following ranges:

1. Pressure drop - plus or minus 1.0 inch of water column

2. Liquid flow rate - plus or minus 10 gpm of the indicated liquid flow rate. [R307-401-8]

12
II.B.2.d.2 The parameters shall be monitored with instruments located such that an inspector/operator can
safely read the output any time. All instruments shall be calibrated according to the
manufacturer's instructions at least once every 12 months. Recording of the reading is required
on a once per operational day basis. [R307-401-8]

Status: In Compliance. At the time of inspection, the pressure drop was observed to be 1.2
inches of water column for Tower 1 and 1.4 inches of water column for Tower 2. The
cooling water flow rate was observed to be 38 gpm for Tower 1 and 57 gpm for Tower 2.
Readings are monitored at all times. Calibration for Tower 1 occurred on February 28,
2023. Calibration for Tower 2 occurred on May 31, 2023.

II.B.2.e The owner/operator shall use Scrubber Tower 3 to control process streams from the four (4) fiber
spinning lines (5, 6, 7, & 8). This wet scrubber shall be sized to handle at least 7,500 scfm for the
existing conditions. All exhaust air from these fiber spinning lines shall be routed through the
scrubber before being vented to the atmosphere. [R307-401-8]

Status: In Compliance. Scrubber Tower 3 was observed to control the process streams
from the four fiber spinning lines 5, 6, 7, and 8.

II.B.2.f The owner/operator shall maintain the following operating parameters for Scrubber Tower 3
within the indicated ranges below:

1. The pressure drop shall be less than 2.5 inches of water column

2. The liquid flow rate shall not be less than 30 gpm. [R307-401-8]

II.B.2.f.1 The readings shall be accurate to within the following ranges:

1. Pressure drop - plus or minus 1.0 inch of water column

2. Liquid flow rate - plus or minus 10 gpm of the indicated liquid flow rate. [R307-401-8]

II.B.2.f.2 The parameters shall be monitored with instruments located such that an inspector/operator can
safely read the output any time. All instruments shall be calibrated according to the
manufacturer's instructions at least once every 12 months. Recording of the reading is required
on a once per operational day basis. [R307-401-8]

Status: In Compliance. At the time of inspection, the pressure drop was observed to be 1.1
inches of water column, and the cooling water flow rate was observed to be 70 gpm.
Readings are monitored at all times. Calibration for Tower 3 occurred on February 28,
2023, and May 31, 2023.

II.B.2.g The owner/operator shall use Scrubber Tower 4 to control process streams from the two (2) fiber
spinning lines (9 & 10). This wet scrubber shall be sized to handle at least 5,000 scfm for the
existing conditions. All exhaust air from these fiber spinning lines shall be routed through the
scrubber before being vented to the atmosphere. [R307-401-8]

Status: In Compliance. Scrubber Tower 4 was observed to control the process streams
from the two fiber spinning lines 9 and 10.

II.B.2.h The owner/operator shall maintain the following operating parameters for Scrubber Tower 4
within the indicated ranges below:

1. The pressure drop shall be less than 3.0 inches of water column

2. The liquid flow rate shall not be less than 130 gpm. [R307-401-8]

13
II.B.2.h.1 The readings shall be accurate to within the following ranges:

1. Pressure drop - plus or minus 1.0 inch of water column

2. Liquid flow rate - plus or minus 10 gpm of the indicated liquid flow rate. [R307-401-8]

II.B.2.h.2 The parameters shall be monitored with instruments located such that an inspector/operator can
safely read the output any time. All instruments shall be calibrated according to the
manufacturer's instructions at least once every 12 months. Recording of the reading is required
on a once per operational day basis. [R307-401-8]

Status: In Compliance. At the time of inspection, the pressure drop was observed to be 0.36
inches of water column, and the liquid flow rate was 155 gpm. Annual calibration for
Tower 4 took place on February 28, 2023, and May 31, 2023.

II.B.2.i The owner/operator shall use dual-tower packed-bed Scrubber 6 to control process streams from
the two (2) dialyzer fiber production lines (11 & 12). This wet scrubber shall be sized to handle
at least 7,500 scfm for the existing conditions. All exhaust air from the dialyzer fiber production
lines shall be routed through the scrubber before being vented to the atmosphere. [R307-401-8]

Status: In Compliance. Scrubber Tower 6 was observed to control the process streams
from the two fiber production lines 11 and 12.

II.B.2.j The owner/operator shall maintain the following operating parameters for the dual-tower packed-
bed Scrubber 6 within the indicated ranges below:

1. The pressure drop shall be less than 2.5 inches of water column

2. The liquid flow rate shall not be less than 30 gpm. [R307-401-8]

II.B.2.j.1 The readings shall be accurate to within the following ranges:

1. Pressure drop - plus or minus 1.0 inch of water column

2. Liquid flow rate - plus or minus 10 gpm of the indicated liquid flow rate. [R307-401-8]

II.B.2.j.2 The parameters shall be monitored with instruments located such that an inspector/operator can
safely read the output any time. All instruments shall be calibrated according to the
manufacturer's instructions at least once every 12 months. Recording of the reading is required
on a once per operational day basis. [R307-401-8]

Status: In Compliance. At the time of inspection, the pressure drop was observed to be 0.37
inches of water column, and the liquid flow rate was 98.1 gpm. Annual calibration for
Tower 6 took place on February 28, 2023, and May 31, 2023.

II.B.2.k The owner/operator shall use activated carbon drum located in the polyurethane (PU) room to
control the air streams from two flammable cabinets that are connected in series, each cabinet
containing fresh or waste MeCl. All exhaust air from these cabinets shall be routed through the
activated carbon drum before being vented to the atmosphere. [R307-401-8]

Status: In Compliance. The source confirmed the activated carbon drum is located in the
PU room and controls the air streams for the two flammable cabinets.

II.B.2.l The owner/operator shall maintain and replace the activated carbon drum to avoid breakthrough
in accordance with the manufacturer's recommendations and/or instructions. [R307-401-8]

Status: In Compliance. The drum is maintained and tracked in accordance with the
requirements of this condition.

14
II.B.2.m The owner/operator shall use Scrubber #2 to control emissions from Drum Dryer #3. All exhaust
streams shall be routed through the scrubber before being vented to the atmosphere.
[R307-401-8]

Status: In Compliance. Drum dryer #3 emissions are routed through Scrubber Tower 2.

II.B.3 Combustion Equipment: Boilers, Emergency Generators and Fire Pump Engines

II.B.3.a The owner/operator shall not operate each emergency generator 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. [40 CFR 63 Subpart ZZZZZ, R307-401-8]

II.B.3.a.1 Emergency generator engines shall be used for electricity-producing operation only during the
periods when electric power from the public utilities is interrupted, or for regular maintenance of
the generator engines. [R307-401-8]

II.B.3.a.2 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 generator engine shall be kept in a log and shall
include the following:

A. The date the emergency generator engine was used

B. The duration of operation in hours

C. The reason for the emergency generator engine usage. [R307-401-8]

Status: In Compliance. No generator was run for more than 100 hours in the rolling
12-month period from October 2022, through September 2023. See the attached table
below under column "Sep-23 12-month rolling total" for each individual generator.

II.B.3.b The owner/operator shall not operate each fire pump engine for more than 59 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]

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 fire pump engine shall be kept in a log and shall
include the following:

A. The date the emergency fire pump engine was used

B. The duration of operation in hours

C. The reason for the emergency fire pump engine usage. [40 CFR 63 Subpart ZZZZ,
R307-401-8]

Status: In Compliance. No fire pump engine was run for more than 59 hours in the rolling
12-month period from October 2022, through September 2023. See the attached table
below under column "Sep-23 12-month rolling total" for each individual fire pump engine.

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

Status: In Compliance. Each emergency generator and each fire pump engine were
equipped with a non-resettable hour meter.

15
II.B.3.d The owner/operator shall use natural gas or diesel fuel (e.g. fuel oil #1, #2, or diesel fuel oil
additives) as fuel in each emergency engine. [R307-401-8]

II.B.3.d.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.d.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. Only ULSD is used at this source. See the attached fuel invoice from
HF Sinclair.

II.B.3.e The owner/operator shall not consume more than the following for the boilers:

A. 50,000 gallons of total fuel oil consumed in Boilers #3, #6 through #9, #14 and #15 per
rolling 12-month period

B. 168 hours of operation each for Boilers #3, #6 through #9, and #15 per rolling 12-month
period when burning fuel oil

C. 200 hours of operation each for Boilers #14 and #16 per rolling 12-month period when
burning fuel oil

D. 1,705 million standard cubic feet of total natural gas consumed per rolling 12-month
period. [R307-401-8]

II.B.3.e.1 To determine compliance with a rolling 12-month total, the owner/operator shall

A. Record monthly fuel oil consumption for Boilers #3, #6 through #9, #14 and #15 in an
operations log

B. Record monthly hours of boiler operation on fuel oil in an operations log

C. Calculate a new 12-month total using data from the previous 12 months no later than 20
days after the end of each month

D. Determine natural gas consumption by fuel supplier billing records

E. Keep the records for all periods when the plant is in operation. [R307-401-8]

Status: In Compliance. For the rolling 12-month period from October 2022, through
September 2023, consumption totals are as follows:

A) 0 gallons of fuel oil consumed in these boilers
B) 0 hours of operation with fuel oil for these boilers
C) 0 hours of operation with fuel oil for these boilers
D) 1,195 million standard cubic feet of natural consumption

II.B.3.f The owner/operator shall retrofit Boiler #14 with an ultra-low NOx burner. The burner shall be
certified to meet a NOx emission concentration of 9 ppm or lower when burning natural gas as a
fuel. [R307-401-8]

II.B.3.f.1 The owner/operator shall keep a record of the manufacturer's certification of the emission
concentration. The record shall be kept for the life of the equipment. [R307-401-8]

Status: In Compliance. See the attached manufacturer’s certification as well as
maintenance records for Boiler # 14.

16
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. Compliance with this subpart is satisfied by operating the boilers on only
natural gas and tracking use of natural gas. The boilers did not operate on fuel oil during the last 12
months.

NSPS (Part 60) IIII : Standards of Performance for Stationary Compression Ignition Internal Combustion
Engines

Status: In Compliance. This subpart is applicable to all diesel-fired emergency generators at the source
location manufactured after April 1, 2006. Compliance with this subpart is satisfied by maintaining and
operating the engines in accordance with manufacturer's instructions, use of low sulfur diesel fuel, and
not exceeding 100 hours per year for non-emergency use. The source confirmed they operate the
generators in accordance with manufacturer's instructions with maintenance being conducted per the
manufacturer's specifications. Each engine is equipped with a non-resettable hour meter with use being
tracked and categorized.

NSPS (Part 60) JJJJ : Standards of Performance for Stationary Spark Ignition Internal Combustion Engines

Status: In Compliance. This subpart is applicable to the single natural gas-fired emergency generator at
the source location that was manufactured on January 16, 2014. Compliance with this subpart is
satisfied by maintaining and operating the engine in accordance with manufacturer's instructions, use of
low sulfur diesel fuel, and not exceeding 100 hours per year for non-emergency use. The source
confirmed they operate the generator in accordance with manufacturer's instructions with maintenance
being conducted per the manufacturer's specifications. The engine is equipped with a non-resettable
hour meter with use being tracked and categorized.

MACT (Part 63) JJJJJJ : National Emission Standards for Hazardous Air Pollutants for Industrial,
Commercial, and Institutional Boilers Area Sources

Status: Not Applicable. None of the dual-fuel boilers operated on fuel oil during the last rolling
12-month reporting period.

AREA SOURCE RULES EVALUATION:

The following Area Source Rules were evaluated during this inspection:

Emission Standards: Sulfur Content of Fuels [R307-203]

Status: In Compliance. Only ULSD is used at this source. See the attached fuel invoice from HF
Sinclair.

17
Stationary Sources [R307-210]

Status: In Compliance. Compliance with this area source rule is satisfied by compliance with federal
subparts Dc, IIII, and JJJJ. See Section III for more information.

National Emission Standards for Hazardous Air Pollutants [R307-214]

Status: In Compliance. Compliance with this area source rule is satisfied by compliance with federal
subpart ZZZZ. See Section III for more information.

EMISSION INVENTORY:
Listed before are the Actual Emissions Inventory provided from Fresenius Medical Care - Ogden Dialysis
Products Manufacturing 2022 emissions reporting year. A comparison of the estimated total potential
emissions (PTE) on AO: DAQE-AN109510024-23, dated August 15, 2023, is provided.
PTE are supplied for supplemental purposes only.

Criteria Pollutant PTE tons/yr Actuals tons/yr
CO2 Equivalent 103222.00 NA
Carbon Monoxide 67.02 54.07824
Nitrogen Oxides 60.54 27.64133
Particulate Matter - PM10 9.87 4.87996
Particulate Matter - PM2.5 9.87 4.87986
Sulfur Dioxide 6.91 0.46135
Volatile Organic Compounds 36.16 22.95968
Hazardous Air Pollutant PTE lbs/yr Actuals lbs/yr
Formaldehyde (CAS #50000) 26 9.034
Generic HAPs (CAS #GHAPS) 1920 NA
Hexane (CAS #110543) 628 231.126
Methylene Chloride (Dichloromethane) (CAS #75092) 2000 NA

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

COMPLIANCE STATUS &
RECOMMENDATIONS: In regards to Approval Order (AO) DAQE-AN109510024-23,
dated August 15, 2023: In compliance at the time of inspection.
The facility appears to be well-maintained and operated.

HPV STATUS: Not Applicable.

RECOMMENDATION FOR
NEXT INSPECTION: Safety glasses and hearing protection are required PPE for this
inspection.

NSR RECOMMENDATIONS: Change ZZZZZ to ZZZZ in Condition II.B.3.a

ATTACHMENTS: VEO Form, isopropyl alcohol consumption, VOC and HAP
emissions, generator and fire pump usage, gauge calibration,
NOx certification
I.8 – Notification of Completion of AO Construction and Active Status
This project is complete. An email was sent to Director, Bryce Bird and Enqiang He, to submit
documentation for the completion of the project.

II.B.1.b – Consumption of Isopropyl Alcohol

II.B.1.c. – VOC & HAPS Emissions

II.B.1.c. – VOC & HAPS Emissions continued

II.B.1.c – II.B.2.j.2 – Calibrations of Scrubbers
 See separate attachment

II.B.3.a.2 & II.B.3.b – Hours of Emergency Engine Usage & Hours of Fire Pump Usage

Approval Order Monthly Run-Time Limits
Generators < 100 hours per generator per 12-month rolling period
Fire Pumps < 59 hours per fire pump per 12-month rolling total

II.b.3.d.2 – Proof of ULSD Usage/Purchase

II.B.3.e – Boiler Limits

*Note – Other than testing, our Boilers have not ran on Diesel in the 12 months.