NC0006564_Draft_MM_20220829

Baxter Healthcare Corp
NC0006564
Draft Fact Sheet
NPDES Permit No. NC0006564
Permit Writer/Email Contact Amirhossein Adaryani, [e-mail]:
Date: July 13, 2022
Division/Branch: NC Division of Water Resources/NPDES Complex Permitting
Fact Sheet Template: Version 09Jan2017
Permitting Action:
❑ Renewal
❑ Renewal with Expansion
❑ New Discharge
© Modification (Fact Sheet should be tailored to mod request)
1. Basic Facility Information
Facility Information
Applicant/Facility Name:
Baxter Healthcare Corporation
Applicant Address:
65 Pitts Station Rd, Marion, NC 28752
Facility Address:
US Highway 221 at North Cove, Marion, NC 28752
Permitted Flow:
1.2 MGD
Facility Type/Waste:
50% domestic/50% industrial
Facility Class:
Class 3
Treatment Units:
Non -contact Cooling Water, Boiler Feed Water, Process Water, and
Sanitary Wastewater
Pretreatment Program (Y/N)
N
County:
McDowell
Region
Asheville
Briefly describe the proposed permitting action and facility background:
NPDES permitting history
The Baxter Corporation requires a National Pollutant Discharge Elimination System (NPDES) discharge
permit to dispose of treated non -contact cooling water, boiler feed water, process wastewater, and sanitary
wastewater through surface water discharge. The facility manufactures sterile liquid solutions in flexible
bags for medical procedures. Baxter Corporation's NPDES permit expired January 31, 2020; the permit
renewed to be effective on April 15, 2022. The permit was adjudicated by the permittee and a major
modification application submitted to the Division on June 21, 2022.
The source of the wastewater is non -contact cooling water, boiler feed water, process water, and sanitary
wastewater. The facility upgraded its wastewater treatment system and relocated the outfall (001) 550 ft.
upstream to accommodate the upgrade.
After treatment, wastewater is discharged through outfall 001 into the North Fork Catawba River, which is
classified B-Trout Waters, in the Catawba River Basin.
In 1995, the Division of Water Resources issued an Authorization to Construct that permitted the
construction of a new outfall into the North Fork Catawba River 3.2 miles upstream of the confluence with
Armstrong Creek. Prior to 1996, Baxter Healthcare and American Threads discharged through outfalls
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Baxter Healthcare Corp NC0006564
constructed at the same location in the North Fork Catawba River (0.2 miles downstream of the confluence
with Armstrong Creek).
STREAM CONDITIONS
Baxter Healthcare discharges into the North Fork Catawba River, 3.2 miles upstream of the confluence with
Armstrong Creek. In 1994, DWR modeled the North Fork Catawba River from Baxter Corporation's outfall
to Lake James. The model included the interactions of Baxter's discharge with American Threads (no
longer exists). The North Fork Catawba River changes classification at the confluence of Armstrong Creek
and North Fork Catawba River. The upstream classification is B —Tr and the downstream classification is
C. The model was based on the BOD load of 1321 (daily max) and 880 (monthly average). The current
load is substantially lower.
The model indicated that dissolved oxygen concentrations from the outfall to the confluence with
Armstrong Creek did not fall below the state standard of 6.0 mg/L for trout waters. The lowest predicted
value in this reach did not fall below 7.0 mg/L.
Current permitting actions:
In major modification the facility asked for the following items:
- Compliance schedule for temperature
- Reduction in monitoring to weekly and reassessment of turbidity monitoring after one year
- Reduction in monitoring to weekly in accordance with EPA's 1996 interim guidance for NH3-N,
BOD, COD, TSS, FC
- Removing of NH3-N winter limit
Turbidity monitoring and a footnote to effluent temperature monitoring was added, per 15A NCAC 02B
.0211(18) and (21), and .0219, the temperature for trout waters shall not be increased more than 0.5 °C due
to the discharge of heated liquids and not exceed 20°C when the upstream temperature is less than 20°C.
Special condition A. (3.) added for temperature compliance schedule and condition A. (4.) added for
turbidity monitoring.
2. Receiving Waterbodv Information:
Receiving Waterbody Information
Outfalls/Receiving Stream(s):
Outfall 001— North Fork Catawba River
Stream Segment:
11-24-(2.5)
Stream Classification:
B, Tr
Drainage Area (mi2):
31.5
Summer 7Q10 (cfs)
10.2
Winter 7Q10 (cfs):
15.2
30Q2 (cfs):
Average Flow (cfs):
63
IWC (% effluent):
16
303(d) listed/parameter:
No
Subject to TMDL/parameter:
Yes- Statewide Mercury TMDL implementation.
Basin/Sub-basin/HUC:
North Fork Catawba River/03-08-30/03050101
USGS Topo Quad:
D10SE
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Baxter Healthcare Corp
NC0006564
3. Effluent Data Summary
Effluent data for Outfall 001 is summarized below for the period of November 2017 to November 2021.
Table. Effluent Data Summary Outfall 001
Parameter
Units
Average
Max
Min
Permit
Limit
Flow
MGD
0.94
1.54
0.19
MA 1.2
BOD5, 20°C
lbs/day
19.39
124.66
<3.21
MA 460.9
DM 691.4
COD
lbs/day
38.71
154.69
<8.02
MA 1,292.8
DM 1,939.2
Total Suspended Solids
lbs/day
9.26
68.75
<1.6
MA 278
DM 417
Fecal Coliform
#/100mL
MA 200
DM400
Total Residual Chlorine4
µg/1
limits only apply if chlorine
is used
DM 28.0
< 50
compliance)
Temperature
° C
25.92
35
9.3
Monitor
3/week
Conductivity
µS/cm
1,283.14
2,397
429
Monitor
3/week
Dissolved Oxygen,
mg/1
7.64
12.2
5.7
Monitor
3/week
pH
SU
--
7.6
6.4
6.0>pH<
9.0
Oil & Grease
lbs/day
39.90
84.99
<8.02
MA 47.7
DM 95.4
NH3-N
mg/1
0.15
3.1
<0.1
Monitor
2/month
Total Nitrogen
(NO2 + NO3 + TKN)
mg/1
7.40
23.4
0.85
Monitor
1/month
Total Phosphorus
mg/1
1.63
5.5
0.09
Monitor
1/month
Chronic Toxicity
pass/fail
Monitor
1/quarter
MA -Monthly Average, WA -Weekly Average, DM -Daily Maximum, DA=Daily Average
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Baxter Healthcare Corp NC0006564
4. Instream Data Summary
Instream monitoring may be required in certain situations, for example: 1) to verify model predictions when
model results for instream DO are within 1 mg/1 of instream standard at full permitted flow; 2) to verify
model predictions for outfall diffuser; 3) to provide data for future TMDL; 4) based on other instream
concerns. Instream monitoring may be conducted by the Permittee, and there are also Monitoring Coalitions
established in several basins that conduct instream sampling for the Permittee (in which case instream
monitoring is waived in the permit as long as coalition membership is maintained).
If applicable, summarize any instream data and what instream monitoring will be proposed for this permit
action: The current permit requires instream monitoring for dissolved oxygen, temperature, fecal coliform,
and conductivity for Class B, Trout Waters, per 15A NCAC 02B .0200. Review of instream data for the
past four years is summarized below.
Location
Temperature (°C)
Avg
Max
Min
Upstream
15.84
23.8
0
Downstream
16.51
24.3
0
There were differences in temperatures upstream and downstream reported which could violate standard
15A NCAC 02B .0211(18), which requires that the temperature for trout waters shall not be increased by
more than 0.5 °C above the background temperature and not exceed 20 °C. Footnote will be added to the
effluent temperature monitoring limit in the permit.
Is this facility a member of a Monitoring Coalition with waived instream monitoring (Y/N). No
Name of Monitoring Coalition: NA
5. Compliance Summary
Summarize the compliance record with permit effluent limits (past 5 years): The facility reported no limit
violations.
Summarize the compliance record with aquatic toxicity test limits and any second species test results (past
5 years): The facility passed 16 of 16 quarterly chronic toxicity tests between August 2018 and May 2022.
Summarize the results from the most recent compliance inspection: The last facility inspection conducted
December 28, 2021, reported that the facility was well maintained and operated.
6. Water Quality -Based Effluent Limitations (WQBELs)
Dilution and Mixing Zones
In accordance with 15A NCAC 2B.0206, the following streamflows are used for dilution considerations
for development of WQBELs: 1 Q 10 streamflow (acute Aquatic Life); 7Q10 streamflow (chronic Aquatic
Life; non -carcinogen HH); 30Q2 streamflow (aesthetics); annual average flow (carcinogen, HH).
If applicable, describe any other dilution factors considered (e.g., based on CORMIX model results): NA
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Baxter Healthcare Corp NC0006564
If applicable, describe any mixing zones established in accordance with 15A NCAC 2B.0204(b): NA
Oxygen -Consuming Waste Limitations
Limitations for oxygen -consuming waste (e.g., BOD) are generally based on water quality modeling to
ensure protection of the instream dissolved oxygen (DO) water quality standard. Secondary TBEL limits
(e.g., BOD= 30 mg/1 for Municipals) may be appropriate if deemed more stringent based on dilution and
model results.
If permit limits are more stringent than TBELs, describe how limits were developed: NA
Ammonia and Total Residual Chlorine Limitations
Limitations for ammonia are based on protection of aquatic life utilizing an ammonia chronic criterion of
1.0 mg/1 (summer) and 1.8 mg/1 (winter). Acute ammonia limits are derived from chronic criteria, utilizing
a multiplication factor of 3 for Municipals and a multiplication factor of 5 for Non -Municipals.
Limitations for Total Residual Chlorine (TRC) are based on the NC water quality standard for protection
of aquatic life (17 ug/1) and capped at 28 ug/1 (acute impacts). Due to analytical issues, all TRC values
reported below 50 ug/1 are considered compliant with their permit limit.
Describe any proposed changes to ammonia and/or TRC limits for this permit renewal: N/A
Reasonable Potential Analysis (RPA) for Toxicants
The need for toxicant limits is based upon a demonstration of reasonable potential to exceed water quality
standards, a statistical evaluation that is conducted during every permit renewal utilizing the most recent
effluent data for each outfall. The RPA is conducted in accordance with 40 CFR 122.44 (d) (i). The NC
RPA procedure utilizes the following: 1) 95% Confidence Level/95% Probability; 2) assumption of zero
background; 3) use of 1/2 detection limit for "less than" values; and 4) streamflows used for dilution
consideration based on 15A NCAC 2B.0206. Effective April 6, 2016, NC began implementation of
dissolved metals criteria in the RPA process in accordance with guidance titled NPDES Implementation of
Instream Dissolved Metals Standards, dated June 10, 2016.
A reasonable potential analysis was conducted on effluent toxicant data collected between November 2017
and November 2021. Pollutants of concern included toxicants with positive detections and associated water
quality standards/criteria. Based on this analysis, the following permitting actions are proposed for this
permit:
• Effluent Limit with Monitoring. The following parameters will receive a water quality -based
effluent limit (WQBEL) since they demonstrated a reasonable potential to exceed applicable water
quality standards/criteria: None
• Monitoring Only. The following parameters will receive a monitor -only requirement since they
did not demonstrate reasonable potential to exceed applicable water quality standards/criteria, but
the maximum predicted concentration was >50% of the allowable concentration: None
• No Limit or Monitoring: The following parameters will not receive a limit or monitoring, since
they did not demonstrate reasonable potential to exceed applicable water quality standards/criteria
and the maximum predicted concentration was <50% of the allowable concentration: None
Toxicity Testing Limitations
Permit limits and monitoring requirements for Whole Effluent Toxicity (WET) have been established in
accordance with Division guidance (per WET Memo, 8/2/1999). Per WET guidance, all NPDES permits
issued to Major facilities or any facility discharging "complex" wastewater (contains anything other than
domestic waste) will contain appropriate WET limits and monitoring requirements, with several exceptions.
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Baxter Healthcare Corp NC0006564
The State has received prior EPA approval to use an Alternative WET Test Procedure in NPDES permits,
using single concentration screening tests, with multiple dilution follow-up upon a test failure.
Describe proposed toxicity test requirement: The current permit requires quarterly chronic toxicity testing
at 16% using Ceriodaphnia dubia. No changes are proposed.
Mercury Statewide TMDL Evaluation
There is a statewide TMDL for mercury approved by EPA in 2012. The TMDL target was to comply with
EPA's mercury fish tissue criteria (0.3 mg/kg) for human health protection. The TMDL established a
wasteload allocation for point sources of 37 kg/year (81 lb/year) and is applicable to municipals and
industrial facilities with known mercury discharges. Given the small contribution of mercury from point
sources (-2% of total load), the TMDL emphasizes mercury minimization plans (MMPs) for point source
control. Municipal facilities > 2 MGD and discharging quantifiable levels of mercury (>1 ng/1) will receive
an MMP requirement. Industrials are evaluated on a case -by -case basis, depending on if mercury is a
pollutant of concern. Effluent limits may also be added if annual average effluent concentrations exceed
the WQBEL value (based on the NC WQS of 12 ng/1) and/or if any individual value exceeds a TBEL value
of 47 ng/1
Describe proposed permit actions based on mercury evaluation: The current permit does not include limits
or monitoring requirements. Mercury is not expected to be present in effluent, no MMP or limit is required.
No changes are proposed.
Other TMDL/Nutrient Management Strategy Considerations
If applicable, describe any other TMDLs/Nutrient Management Strategies and their implementation within
this permit: The facility is currently required to monitor TN and TP monthly, no changes are proposed.
Other WQBEL Considerations
If applicable, describe any other parameters of concern evaluated for WQBELs: NA
If applicable, describe any special actions (HQW or ORW) this receiving stream and classification shall
comply with in order to protect the designated waterbody: NA
If applicable, describe any compliance schedules proposed for this permit renewal in accordance with 15A
NCAC 2H.0107(c) (2) (B), 40CFR 122.47, and EPA May 2007 Memo:
Compliance schedule for temperature: 10 years eDMR of data have been evaluated for effluent, and 6 years
of available data for instream monitoring. Since June 2016 (establishment of instream monitoring), the daily
average effluent temperature is 23.2 °C, with a maximum of 35 °C. Both may be higher than allowed limits.
The permittee has requested five years to evaluate alternatives, design, construct and make operational
changes to meet outfall 001 and instream temperature criteria. The Division determination is that three
years and six months would be adequate. Therefore, a special condition will be added for the permittee to
conduct evaluation and to submit for approval a Corrective Action Plan (CAP) no later than September 1,
2023. The approved CAP will include actions to be completed by defined dates with compliance no later
than two years and six months from submission of the CAP. The steps listed in special condition, the actions
and deadlines listed in the approved CAP will be considered enforceable parts of the permit.
If applicable, describe any water quality standards variances proposed in accordance with NCGS 143-
215.3(e) and 15A NCAC 2B. 0226 for this permit renewal: NA
7. Technology -Based Effluent Limitations (TBELs)
Describe what this facility produces: Pharmaceuticals, sterile liquid in flexible bags.
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Baxter Healthcare Corp NC0006564
List the federal effluent limitations guideline (ELG) for this facility: 40 CFR 439 Subpart D, 40 CFR 463
Subpart A, 40 CFR 133 secondary treatment standards, and BPJ.
If the ELG is based on production or flow, document how the average production/flow value was calculated:
This ELG is based on the following flows: cooling water from the extruders, non -contact cooling water,
boiler feed, process, and sanitary wastewater streams. The pollutant loading for each process are
summarized below. The information was provided by the facility in 2004, since there have not been any
significant changes in manufacturing, these data were used in the 2004, 2010, 2016, 2022 permit renewal.
Source flow
BOD5 (lb/day) COD (lb/day) TSS (lb/day)
Extrusion ' 106.2 174.2 97.1
Boiler feed 0 0 84.1
Process 1,900.9 3,088.8 28.9
Sanitary 666.7 1,092.9 229
For ELG limits, document the calculations used to develop TBEL limits:
• BOD5, COD, and TSS are based on 40 CFR 439 Subpart D and secondary treatment standards for
the sanitary wastewater component.
• Oil and Grease limits for the cooling water from the extruders are based on 40 CFR 463 Subpart
A, the sanitary wastewater limits are based on BPJ of 30 mg/L DM and 60 mg/L MA.
Comparison of the recalculated limits using current flow data and current permit limits are summarized
below for comparison. The calculated limits are less stringent than the current permit. Since the facility
has no current plans for expansion no changes are proposed.
Table. TBEL Development per 40 CFR 133, 40 CFR 439 Subpart D, 40 CFR 463 Subpart A
Pollutant
Daily Max
Limit
(lb /d)
Current Limit
(lb/d)
Monthly Average
Limit
(lb/d)
Current Limit
(lb/d)
BOD5
645.21
691.40
430.14
460.90
COD
1,766.79
1,939.20
1,177.86
1,292.80
TSS
1,123.48
417.00
748.99
278.00
O&G
95.86
95.40
47.93
47.70
If any limits are based on best professional judgement (BPJ), describe development: The allocation for Oil
and Grease for the sanitary wastewater are based on BPJ of 30 mg/L DM and 60 mg/L MA.
Document any TBELs that are more stringent than WQBELs: The TBELs limits for BOD, COD, Oil and
Grease, and TSS are more stringent than the 1994 model conducted by the Division.
Document any TBELs that are less stringent than previous permit: NA
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Baxter Healthcare Corp NC0006564
8. Antidegradation Review (New/Expanding Discharge):
The objective of an antidegradation review is to ensure that a new or increased pollutant loading will not
degrade water quality. Permitting actions for new or expanding discharges require an antidegradation
review in accordance with 15A NCAC 2B.0201. Each applicant for a new/expanding NPDES permit must
document an effort to consider non -discharge alternatives per 15A NCAC 2H.0105(c)(2). In all cases,
existing instream water uses and the level of water quality necessary to protect the existing use is maintained
and protected.
If applicable, describe the results of the antidegradation review, including the Engineering Alternatives
Analysis (EAA) and any water quality modeling results: NA
9. Antibacksliding Review:
Sections 402(o)(2) and 303(d)(4) of the CWA and federal regulations at 40 CFR 122.44(1) prohibit
backsliding of effluent limitations in NPDES permits. These provisions require effluent limitations in a
reissued permit to be as stringent as those in the previous permit, with some exceptions where limitations
may be relaxed (e.g., based on new information, increases in production may warrant less stringent TBEL
limits, or WQBELs may be less stringent based on updated RPA or dilution).
Are any effluent limitations less stringent than previous permit (YES/NO): NO
If YES, confirm that antibacksliding provisions are not violated: NA
10. Monitoring Requirements
Monitoring frequencies for NPDES permitting are established in accordance with the following regulations
and guidance: 1) State Regulation for Surface Water Monitoring, 15A NCAC 2B.0500; 2) NPDES
Guidance, Monitoring Frequency for Toxic Substances (7/15/2010 Memo); 3) NPDES Guidance, Reduced
Monitoring Frequencies for Facilities with Superior Compliance (10/22/2012 Memo); 4) Best Professional
Judgement (BPJ). Per US EPA (Interim Guidance, 1996), monitoring requirements are not considered
effluent limitations under Section 402(o) of the Clean Water Act, and therefore anti -backsliding
prohibitions would not be triggered by reductions in monitoring frequencies.
11. Electronic Reporting Requirements
The US EPA NPDES Electronic Reporting Rule was finalized on December 21, 2015. Effective December
21, 2016, NPDES regulated facilities are required to submit Discharge Monitoring Reports (DMRs)
electronically. While NPDES regulated facilities would initially be required to submit additional NPDES
reports electronically effective December 21, 2020, EPA extended this deadline from December 21, 2020,
to December 21, 2025. The current compliance date, effective January 4, 2021, was extended as a final
regulation change published in the November 2, 2020 Federal Register This permit contains the
requirements for electronic reporting, consistent with Federal requirements.
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Baxter Healthcare Corp
12.Summary of Proposed Permitting Actions:
A. Table. Current Permit Conditions and Proposed Changes 1.2 MGD
NC0006564
Parameter
Current Permit
Proposed Change
Basis for Condition/Change
Flow
MA 1.2 MGD
No change
15A NCAC 2B .0505
BOD5, 20°C
MA 460.9 lbs/day
DM 691.4 lbs/day
No change
TBEL. 40 CFR 439 Subpart D /Secondary
treatment standards/40 CFR 133/15A
NCAC 2B .0406
COD
MA 1,292.8 lbs/day
DM 1,939.2 lbs/day
No change
TBEL. 40 CFR 439 Subpart D /Secondary
treatment standards/40 CFR 133/15A
NCAC 2B .0406
Total Suspended
Solids
MA 278.0 lbs/day
DM 417.0 lbs/day
No change
TBEL. 40 CFR 439 Subpart D /Secondary
treatment standards/40 CFR 133/15A
NCAC 2B .0406
NH3-N summer,
mg/L
MA 5.3 mg/L
DM 26.4 mg/L
No change
WQBEL. Based on protection of aquatic
life. 15A NCAC 2B.0200
NH3-N winter, mg/L
MA 14.7 mg/L
No change
WQBEL. Based on protection of aquatic
life. 15A NCAC 2B.0200
Fecal Coliform
MA 200 /100m1
DM 400 /100m1
No change
WQBEL. State WQ standard, 15A NCAC
2B .0200
Total Residual
Chlorine4
28 µg/L
No change
WQBEL. State WQ standard, 15A NCAC
2B .0200
Turbidity, NTU
DM 10 NTUs
No change
WQBEL. State WQ standard, 15A NCAC
2B .0211(21)
Temperature, °C
Monitor 3/week
No change
WQBEL. State WQ standard, 15A NCAC
2B .0200 and 15A NCAC 02B .0500
Conductivity,
µS/cm
Monitor 3/week
No change
WQBEL. State WQ standard, 15A NCAC
2B .0200 and 15A NCAC 02B .0500
Dissolved Oxygen,
mg/L
Monitor 3/week
No change
WQBEL. State WQ standard, 15A NCAC
2B .0200 and 15A NCAC 02B .0500
pH
>6.0 and < 9.0 SU
No change
WQBEL. State WQ standard, 15A NCAC
2B .0200 and 15A NCAC 02B .0500
Oil & Grease
MA 47.7 lbs/day
DM 95.4 lbs/day
Monitor 2/month
No change
TBEL. 40 CFR 463/BPJ/40 CFR 133 /15A
NCAC 2B .0406
Total Nitrogen
(NO2 + NO3 +
TKN), mg/L
Monitor 1/month
No change
WQBEL. State WQ standard, 15A NCAC
2B .0200 and 15A NCAC 02B .0500
Total Phosphorus,
mg/L
Monitor 1/month
No change
WQBEL. State WQ standard, 15A NCAC
2B .0200 and 15A NCAC 02B .0500
Chronic Toxicity
Monitor 1/quarter
No change
WQBEL. No toxics in toxic amounts. 15A
NCAC 2B.0200 and 15A NCAC 2B.0500
Total hardness as
CaCO3, mg/L
Monitor 1/quarter
No change
Hardness -dependent dissolved metals WQ
standard, 2016
MGD - Million gallons per day, MA - Monthly Average, WA - Weekly Average, DM - Daily Max
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Baxter Healthcare Corp NC0006564
13. Public Notice Schedule:
Permit to Public Notice: XXXX
Per 15A NCAC 2H .0109 & .0111, The Division will receive comments for a period of 30 days following
the publication date of the public notice. Any request for a public hearing shall be submitted to the
Director within the 30 days comment period indicating the interest of the party filing such request and the
reasons why a hearing is warranted.
14. NPDES Division Contact
If you have any questions regarding any of the above information or on the attached permit, please
contact Amirhossein (Amir) Adaryani at [phone] or via email at [e-mail].
15. Fact Sheet Addendum (if applicable):
Were there any changes made since the Draft Permit was public noticed (Yes/No):
If Yes, list changes and their basis below: N/A
16. Fact Sheet Attachments (if applicable):
• Monitoring reduction calculations
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