NC0090239_Fact Sheet_20240328

Major Modification
PermitNCO090239
Fact Sheet
NPDES Permit No. NC00 a0239
Permit Writer/Email Contact: [e-mail]
Date: February 22, 2024
Division/Branch: NC Division of Water Resources / Industrial NPDES Permitting
Fact Sheet Template: Version 09Jan2017
Permitting Action:
❑ Renewal
❑ Renewal with Expansion
❑ New Discharge
❑X Modification (Fact Sheet should be tailored to mod request)
Note: A complete application should include the following:
• For New Dischargers, EPA Form 2A or 2D requirements, Engineering Alternatives Analysis, Fee
• For Existing Dischargers (POTW), EPA Form 2A, 3 effluent pollutant scans, 4 2nd species WET
tests.
• For Existing Dischargers (Non-POTW), EPA Form 2C with correct analytical requirements based
on industry category.
Complete applicable sections below. If not applicable, enter NA.
1. Basic Facility Information
Facility Information
Applicant/Facility Name:
Ely Lilly and Company RTP
Applicant Address:
1420 Concord Parkway South, Concord, NC 28027
Facility Address:
1420 Concord Parkway South, Concord, NC 28027
Permitted Flow:
Not Limited
Facility Type/Waste:
Minor Industrial
Facility Class:
I
Treatment Units:
Three retention basins
Pretreatment Program (Y/N):
N/A
County:
Cabarrus
Region:
Mooresville
Briefly describe the proposed permitting action and facility background. -
Ely Lilly is planning to build a manufacturing facility for pharmaceutical products in Concord. The
operations will include filling syringes with formulated product and assembling devices for parenteral
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Major Modification Permit NC0090239
products. The construction of the facility utilities is estimated to be completed by the end of October
2023.
All process wastewater (non -contact cooling water, equipment wash water, etc.) and sanitary wastewater
will be discharged to Cabarrus County's municipal sewer system. The facility applied for NPDES permit
to discharge clean HVAC condensate commingled with the stormwater. The facility will not use any
chemical additives for the HVAC system. Clean condensate will be discharged to the site stormwater
sewer system, and flow to the three existing stormwater retention basins with a hydraulic capacity of
approximately 0.8 million gallons, 2.4 million gallons, and 6.5 million gallons. Any rainfall will cause the
ponds to discharge water to wetlands that serve as Unnamed Tributaries (UT) to Coddle Creek.
This is a Major Modification to the existing permit. The modification is necessary to accommodate
discharge from 5 groundwater wells (18 gpm flow each) and basement dewatering (300 gpm flow). The
groundwater extraction and basement dewatering will be a permanent feature of this facility designed to
keep the basement dry. The total new discharge calculated to be 0.56 MGD based on the application, it
will be routed to Outfall 002.
2. Receiving Waterbody Information
Receiving Waterbody Information
Outfalls/Receiving Stream(s):
Outfalls 001, 002, and 003 — UT to Coddle Creek
Stream Segment:
13-17-6-(0.5)
Stream Classification:
WS-II, HQW
Drainage Area (mi2):
Summer 7Q10 (cfs):
0
Winter 7Q10 (cfs):
0
30Q2 (cfs):
0
Average Flow (cfs):
0
IWC (% effluent):
100
303(d) listed/parameter:
Yes, fish community is impaired.
Subject to TMDL/parameter:
Yes — State-wide Mercury TMDL implementation.
Sub-basin/HUC:
03-07-12/03040105
USGS Topo Quad:
3. Effluent Data Summary
N/A — New Discharge permitted on/or about 9/22/23.
4. Instream Data Summary
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Major Modification Permit NC0090239
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: N/A. This is a new permit permitted on/or about 9/22/23. Instream monitoring is not
proposed because the receiving stream is a zero -flow stream.
Is this facility a member of a Monitoring Coalition with waived instream monitoring (YIN): N
Name of Monitoring Coalition: N/A
5. Compliance Summary
Summarize the compliance record with permit effluent limits (past 5 years): N/A
Summarize the compliance record with aquatic toxicity test limits and any second species test results
(past 5 years): N/A
Summarize the results from the most recent compliance inspection: N/A
6. Water Quality -Based Effluent Limitations (WQBELs)
Dilution and Mixing Zones
In accordance with 15A NCAC 213.0206, the following stream flows are used for dilution considerations
for development of WQBELs: 1Q10 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): N/A
If applicable, describe any mixing zones established in accordance with 15A NCAC 2B. 0204(b): N/A
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.
Ifpermit limits are more stringent than TBELs, describe how limits were developed: N/A
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.
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Major Modification
PermitNC0090239
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
If applicable, conduct RPA analysis and complete information below.
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/2 detection limit for "less than" values; and 4) stream flows used for dilution
consideration based on 15A NCAC 213.0206. 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 provided by the facility in the
permit application. Pollutants of concern included toxicants with positive detections and associated water
quality standards/criteria. The facility discharges to the zero flow stream and dilution is not available.
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: N/A, discharges mixture of clean HVAC condensate and
stormwater. Discharges are primarily driven by stormwater events.
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: Cr (VI).
The facility conducted Priority Pollutant Analysis of the groundwater that will be added to the
discharge from Outfall 002. The only parameter above detection level out of 126 analyzed was
Total Chromium at 84.7 µg/L. This value is below state chronic water quality standard for Cr
(III), which is established at 117.7 µg/L. However, it is above state chronic water quality
standard for Cr (VI), which is established at 11.0 µg/L. The facility is not expected to discharge
from stormwater basin on a regular basis. The discharge is likely to occur during storm events,
which would dilute groundwater. In addition, the proportion of the Cr(VI) in the groundwater is
unknown. Therefore, Cr (VI) monitoring has been added to Outfall 002 to evaluate potential
impact on the receiving stream.
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: N/A, please see above.
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. The State has received prior EPA approval to use an Alternative WET Test Procedure in
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Major Modification Permit NC0090239
NPDES permits, using single concentration screening tests, with multiple dilution follow-up upon a test
failure.
Describe proposed toxicity test requirement: N/A
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 (M1VIPs) 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 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/l.
Describe proposed permit actions based on mercury evaluation: N/A.
Other TMDL/Nutrient Management Strategy Considerations
If applicable, describe any other TNDDLs/Nutrient Management Strategies and their implementation
within this permit: N/A
Other WQBEL Considerations
If applicable, describe any other parameters of concern evaluated for WQBELs: N/A
If applicable, describe any special actions (HQW or ORW) this receiving stream and classification shall
comply with in order to protect the designated waterbody.
If applicable, describe any compliance schedules proposed for this permit renewal in accordance with
1 SA NCAC 2H 0 10 7 (C) (2) (B), 40CFR 122.47, and EPA May 2007 Memo.
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: N/A
7. Technology -Based Effluent Limitations (TBELs)
Describe what this facility produces: N/A
List the federal effluent limitations guideline (ELG) for this facility: N/A
If the ELG is based on production or flow, document how the average production/flow value was
calculated: N/A
For ELG limits, document the calculations used to develop TBEL limits: N/A
If any limits are based on best professional judgement (BPJ), describe development: N/A
Document any TBELs that are more stringent than WQBELs: N/A
Document any TBELs that are less stringent than previous permit: N/A
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Major Modification Permit NCO090239
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: The facility provided an EAA to justify the
chosen disposal alternative for this new discharge.
The facility reviewed the following available alternatives: Connection to the Existing Publicly Owned
Treatment Works (POTW), Subsurface Seepage and Atmospheric Evaporation, Wastewater Reuse for
Irrigation, Off -site Spray Irrigation, and Direct Discharge.
Connection to the existing POTW was not available since Cabarrus County regulations prohibits the
discharge of clean condensate to the municipal sewer system.
The Present Value Costs for the next 20 years was calculated for the following alternatives:
Subsurface Seepage — $1,007,179
Wastewater Reuse - $527,179
Off -site Spray Irrigation - $1,523,234
Direct Discharge- Costs are negligible since the stormwater ponds already constructed during building
phase.
As compared to other alternatives, and in accordance with 15A NCAC 2H .0105(c)(2), the Engineering
Alternatives Analysis provided justification for a direct discharge to surface water alternative and
indicated that the direct discharge is the most environmentally sound alternative selected from all
reasonably cost-effective options.
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): N/A
If YES, confirm that antibacksliding provisions are not violated. N/A
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
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Major Modification Permit NC0090239
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. Effective December 21, 2020, NPDES regulated facilities will be required to
submit additional NPDES reports electronically. This permit contains the requirements for electronic
reporting, consistent with Federal requirements.
12. Summary of Proposed Permitting Actions
Table A: Outfall 001, Outfall 002, and Outfall 003.
Parameter
Current Permit
Proposed Change
Basis for Condition/Change
Flow
Monitoring
None
15A NCAC 2B .0500
TSS
Monitoring
None
15A NCAC 2B .0500
Oil and
Grease
Monitoring
None
15A NCAC 2B .0500
pH
6.0 — 9.0 SU
None
WQBEL. State WQ standard,
15A NCAC 2B .0200
MGD — Million gallons per day, MA — Monthly Average, DM — Daily Max
Table B: Outfall 002
Parameter
Current Permit
Proposed Change
Basis for Condition/Change
Cr (VI)
N/A
Monitoring added
WQBEL. State WQ standard,
15A NCAC 2B .0200
MGD — Million gallons per day, MA — Monthly Average, DM — Daily Max
13. Public Notice Schedule
Permit to Public Notice: 05/30/2023
Per 15A NCAC 21-1.0109 & .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 parry filing such request and the
reasons why a hearing is warranted.
14. NPDES Division Contact
If you have questions regarding any of the above information or on the attached permit, please contact
Sergei Chernikov at [phone] or via email at [e-mail].
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Major Modification Permit NC0090239
15. Changes in the Draft Major Modification.
• Monitoring for Cr (VI) has been added to Outfall 002 to evaluate potential impact on the
receiving stream.
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