NC0088811_Fact Sheet_20200825

Permit No. NC0088811
DEQ/DWR
FACT SHEET FOR NPDES PERMIT RENEWAL
NPDES NC0088811
Facility Information
Applicant/Facility Name: Pharmaceutical Product Development (PPD), Inc. LLC
Applicant Address: 929 North Front Street; Wilmington,North Carolina 28402
Facility Address: 929 North Front Street; Wilmington,North Carolina 28402
Permitted Flow 0.029 MGD
Type of Waste: Groundwater Remediation(GW-REM) for metals and ammonia
Facility/Permit Status: Class WW-1 /Renewal
County: New Hanover
Miscellaneous
Receiving Stream: NE Cape Stream SC; Sw
Fear River Classification:
Subbasin: 03-06-23 Index No. 18-74-(61)
Drainage Area(mi2): NA 8-Digit HUC: 03030007
Summer 7Q10 (cfs) Tidal 303(d) Listed? No
Winter 7Q10 (cfs): Tidal Regional Office: Wilmington
30Q2 (cfs) Tidal State Grid/USGS K27NW/Wilmington,NC
Quad:
Average Flow (cfs): Tidal * Permit Writer: Joe R. Corporon P.G.
IWC (%): NA * Date: 25Aug2020
*Tidal conditions preclude instream waste concentration(IWC);assume zero-flow conditions;WET test @90%.
BACKGROUND
Pharmaceutical Products Development, Inc. (PPD) constructed an office building on a 7.48-acre
tract formerly used as a chemical terminal by Almont Shipping. Following construction,
groundwater was observed seeping into the lower parking deck and the adjacent courtyard. To
receive a final Certificate of Occupancy, the City of Wilmington required PPD to recover the
seepage and discharge the wastewaters to the City's sanitary sewer under an approved Industrial
User Permit(IUP).
Wilmington issued the IUP with the condition that PPD investigate an alternative disposal
method, and subsequently DWR required PPD to perform an Engineering Alternatives Analysis
(EAA). The EAA concluded that a direct discharge to the Northeast Cape Fear River was the
most economically feasible disposal alternative to a sanitary sewer discharge; DWR concurred.
PPD remains permitted as an Industrial User with Wilmington's POTW, however both parties
understand that this option is temporary and may be discontinued at Wilmington's discretion. To
date, there has been no surface discharge of wastewaters via the NPDES permit. The Permit
requires PPD to notify the Division of intent to discharge at minimum thirty(30) days in advance
to allow adequate time for treatment-facility inspection [see Supplement to Permit Cover Sheet].
Page 1 of 8

Permit No. NC0088811
ASSUMED CONDITIONS FOR WASTEWATER TREATMENT
Depending on rain events 8,000 gpd to 10,500 gpd of recovered groundwater is discharged to the
POTW. The initial analysis of the ground water yielded high levels of ammonia and arsenic.
PPD's original application included an ion-exchange system proposed to reduce ammonia and
arsenic levels in extracted groundwater prior to discharge. A treatability study was conducted to
determine the optimum treatment system configuration to achieve the target treatment goals of
an arsenic human health (HH) standard of 10 ug/L and an ammonia limitation of 2 mg/L. PPD
reported study results showing the proposed treatment system would treat would achieve effluent
concentrations of< 3 mg/L for ammonia and< 10 ug/L for arsenic.
The proposed treatment system would consist of disposable cartridge pre-filters to remove
suspended materials, a series of ion-exchange tanks to remove arsenic and ammonia, plus a pH
adjustment system. In addition, as the ion system becomes spent, a contract service will be hired
to install new units, remove spent units, and assume responsibility for proper permitted disposal
of spent units.
PPD proposed an optimum treatment design flow of 10 gpm(range 2 to 20 gpm). For permitting
purposes 20 gpm or 0.029 MGD was established to limit permitted flow. The discharge would
flow to a local storm drain [under zero-flow receiving-steam conditions], discharging via Outfall
001 approximately 1,000 feet from the site to the Northeast Cape Fear River.
The Northeast Cape Fear is a class SC; Sw [swamp] waterbody within the Cape Fear River Basin
but is simultaneously influenced by tides. This stream segment is listed on the 2018 303(d) list,
impaired for copper.
START-UP PERMITTING STRATEGY
Wastewaters discharged to the POTW were analyzed for the following parameters as part of
PPD's IUP: the metals As, Cd, Cr, Cu, Zn, Ba, Al,Ni, and Mo; evaluations also included
Ammonia, Chloride, TKN, TSS, pH, Conductivity, and Temperature. Twice a year the facility
tests its discharge for additional pollutants such as Ag, CN, Pb, Phosphorus, and Oil & Grease.
Since limited data was submitted on the effluent with the initial application, IUP data collected
from Jan. 2013 through October 2014, after which time the Permittee was granted a Discharge
Reporting Waiver. Data were evaluated to help determine what parameters should continue to be
limited or removed from the permit (see Final Fact Sheet 2015) summarizes the IUP data.
COMPLIANCE REVIEW
This facility has not yet discharged to surface waters.
No toxicity tests or inspections have been performed.
Page 2 of 8

Permit No. NC0088811
SUMMARY OF PROPOSED CHANGES
The draft permit includes the following significant changes from the existing permit:
1. Language has been updated in Section A. (1) and Section A. (4)requiring electronic
submission of effluent data. Federal regulations require electronic submittal of all
discharge monitoring reports (DMRs).
2. Outfall map has been updated.
3. Language on the Supplement to Permit Cover Sheet has been updated.
4. The facility Classification has been updated to include citation [Section A. (1)].
5. Monitoring for Total Hardness has been added in Section A. (1) as monitoring is required
for hardness-dependent metals—effluent and upstream of the discharge.
6. Updated the footnotes in Section A. (1).
7. Toxicity language in Section A. (2)has been updated.
8. Test has been added detailing Metals Evaluation for Total Hardness.
METALS EVALUATION— for TOTAL HARDNESS
NPDES Implementation of Instream Dissolved Metals Standards—Freshwater Standards
The NC 2007-2015 Water Quality Standard(WQS) Triennial Review was approved by the NC
Environmental Management Commission(EMC) on November 13, 2014. The US EPA
subsequently approved the WQS revisions on April 6, 2016,with some exceptions. Therefore,
metal limits in draft permits out to public notice after April 6, 2016 must be calculated to protect
the new standards - as approved.
Table 1. NC Dissolved Metals Water Quality Standards/Aquatic Life Protection
Parameter Acute FW, µg/1 Chronic FW, µg/1 Acute SW, µg/1 Chronic SW, µg/1
(Dissolved) (Dissolved) (Dissolved) (Dissolved)
Arsenic 340 150 69 36
Beryllium 65 6.5 --- ---
Cadmium Calculation Calculation 40 8.8
Chromium III Calculation Calculation --- ---
Chromium VI 16 11 1100 50
Copper Calculation Calculation 4.8 3.1
Lead Calculation Calculation 210 8.1
Nickel Calculation Calculation 74 8.2
Silver Calculation 0.06 1.9 0.1
Zinc Calculation Calculation 90 81
Page 3 of 8

Permit No. NC0088811
Table 1 Notes:
1. FW= Freshwater, SW= Saltwater
2. Calculation = Hardness dependent standard
3. Only the aquatic life standards listed above are expressed in dissolved form. Aquatic life
standards for Mercury and selenium are still expressed as Total Recoverable Metals due
to bioaccumulative concerns (as are all human health standards for all metals). It is still
necessary to evaluate total recoverable aquatic life and human health standards listed in
15A NCAC 2B.0200 (e.g., arsenic at 10 µg/1 for human health protection; cyanide at 5
µg/L and fluoride at 1.8 mg/L for aquatic life protection).
Table 2. Dissolved Freshwater Standards for Hardness -Dependent Metals
The Water Effects Ratio (WER) is equal to one unless determined otherwise under 15A
NCAC 02B .0211 Subparagraph (11)(d)
Metal
NC Dissolved Standard, µg/1
Cadmium, Acute
WER*{1.136672-[ln hardness](0.041838)} • e^{0.9151 [In hardness]-3.1485}
Cadmium, Acute Trout waters
WER*{1.136672-[ln hardness](0.041838)} • e^{0.9151[In hardness]-3.6236}
Cadmium, Chronic
WER*{1.101672-[ln hardness](0.041838)} • e^{0.7998[ln hardness]-4.4451}
Chromium III, Acute
WER*0.316 • e^{0.8190[1n hardness]+3.7256}
Chromium III, Chronic
WER*0.860 • e^{0.8190[ln hardness]+0.6848}
Copper, Acute
WER*0.960 • e^{0.9422[1n hardness]-1.700}
Copper, Chronic
WER*0.960 • e^{0.8545[1n hardness]-1.702}
Lead, Acute
WER*{1.46203-[ln hardness](0.145712)} • e^{1.273[1n hardness]-1.460}
Lead, Chronic
WER*{1.46203-[ln hardness](0.145712)} • e^{1.273[1n hardness]-4.705}
Nickel, Acute
WER*0.998 • e^{0.8460[ln hardness]+2.255}
Nickel, Chronic
WER*0.997 • e^{0.8460[ln hardness]+0.0584}
Silver, Acute
WER*0.85 • e^{1.72[ln hardness]-6.59}
Silver, Chronic
Not applicable
Zinc, Acute
WER*0.978 • e^{0.8473[ln hardness]+0.884}
Zinc, Chronic
WER*0.986 • e^{0.8473[ln hardness]+0.884}
General Information on the Reasonable Potential Analysis (RPA)
The RPA process itself did not change as the result of the new metals standards. However,
application of the dissolved and hardness -dependent standards requires additional consideration
in order to establish the numeric standard for each metal of concern of each individual discharge.
The hardness -based standards require some knowledge of the effluent and instream (upstream)
hardness and so must be calculated case -by -case for each discharge.
Metals limits must be expressed as `total recoverable' metals in accordance with 40 CFR
122.45(c). The discharge -specific standards must be converted to the equivalent total values for
use in the RPA calculations. We will generally rely on default translator values developed for
each metal (more on that below), but it is also possible to consider case -specific translators
developed in accordance with established methodology.
Page 4 of 8

Permit No. NC0088811
RPA Permitting Guidance/WOBELs for Hardness-Dependent Metals -Freshwater
The RPA is designed to predict the maximum likely effluent concentrations for each metal of
concern,based on recent effluent data, and calculate the allowable effluent concentrations, based
on applicable standards and the critical low-flow values for the receiving stream.
If the maximum predicted value is greater than the maximum allowed value (chronic or acute),
the discharge has reasonable potential to exceed the standard, which warrants a permit limit in
most cases. If monitoring for a particular pollutant indicates that the pollutant is not present(i.e.
consistently below detection level), then the Division may remove the monitoring requirement in
the reissued permit.
1. To perform a RPA on the Freshwater hardness-dependent metals the Permit Writer
compiles the following information:
• Critical low flow of the receiving stream, 7Q10 (the spreadsheet automatically
calculates the 1Q10 using the formula 1Q10= 0.843 (s7Q10, cfs) a993
• Effluent hardness and upstream hardness, site-specific data is preferred
• Permitted flow
• Receiving stream classification
2. In order to establish the numeric standard for each hardness-dependent metal of concern
and for each individual discharge, the Permit Writer must first determine what effluent
and instream(upstream) hardness values to use in the equations.
The permit writer reviews DMR's, Effluent Pollutant Scans, and Toxicity Test results for
any hardness data and contacts the Permittee to see if any additional data is available for
instream hardness values,upstream of the discharge.
If no hardness data is available, the permit writer may choose to do an initial evaluation
using a default hardness of 25 mg/L (CaCO3 or(Ca+Mg)). Minimum and maximum
limits on the hardness value used for water quality calculations are 25 mg/L and 400
mg/L, respectively.
If the use of a default hardness value results in a hardness-dependent metal showing
reasonable potential, the permit writer contacts the Permittee and requests 5 site-specific
effluent and upstream hardness samples over a period of one week. The RPA is rerun
using the new data.
The overall hardness value used in the water quality calculations is calculated as follows:
Combined Hardness (chronic) =
(Permitted Flow, cfs *Avg.Effluent Hardness,mg/L)x(s7Q10,cfs *Avg. Upstream Hardness,mg/L)
(Permitted Flow, cfs+s7Q10, cfs)
The Combined Hardness for acute is the same but the calculation uses the 1Q10 flow.
3. The permit writer converts the numeric standard for each metal of concern to a total
recoverable metal, using the EPA Default Partition Coefficients (DPCs) or site-specific
translators, if any have been developed using federally approved methodology.
Page 5 of 8

Permit No. NC0088811
EPA default partition coefficients or the"Fraction Dissolved"converts the value for
dissolved metal at laboratory conditions to total recoverable metal at in-stream
ambient conditions. This factor is calculated using the linear partition coefficients
found in The Metals Translator: Guidance for Calculating a Total Recoverable
Permit Limit from a Dissolved Criterion (EPA 823-B-96-007, June 1996)and the
equation:
Cdiss = 1
Ctotal 1 + { [Kpo] [ss(1+a)] [10-6] }
Where:
ss=in-stream suspended solids concentration [mg/1],minimum of 10 mg/L used,
and Kpo and a=constants that express the equilibrium relationship between
dissolved and adsorbed forms of metals. A list of constants used for each hardness-
dependent metal can also be found in the RPA program under a sheet labeled DPCs.
4. The numeric standard for each metal of concern is divided by the default partition
coefficient(or site-specific translator) to obtain a Total Recoverable Metal at ambient
conditions.
In some cases, where an EPA default partition coefficient translator does not exist(ie.
silver), the dissolved numeric standard for each metal of concern is divided by the EPA
conversion factor to obtain a Total Recoverable Metal at ambient conditions. This
method presumes that the metal is dissolved to the same extent as it was during EPA's
criteria development for metals. For more information on conversion factors see the June,
1996 EPA Translator Guidance Document.
5. The RPA spreadsheet uses a mass balance equation to determine the total allowable
concentration(permit limits) for each pollutant using the following equation:
Ca= (s7Q10+ Qw) (Cwqs)—(s7Q10) (Cb)
Qw
Where: Ca=allowable effluent concentration(µg/L or mg/L)
Cwqs =NC Water Quality Standard or federal criteria(µg/L or mg/L)
Cb=background concentration: assume zero for all toxicants except NH3* (µg/L
or mg/L)
Qw=permitted effluent flow(cfs, match s7Q 10)
s7Q10= summer low flow used to protect aquatic life from chronic toxicity and
human health through the consumption of water, fish, and shellfish from
noncarcinogens (cfs)
* Discussions are on-going with EPA on how best to address background
concentrations
Flows other than s7Q10 may be incorporated as applicable:
1 Q 10 =used in the equation to protect aquatic life from acute toxicity
QA=used in the equation to protect human health through the consumption of
water, fish, and shellfish from carcinogens
30Q2 =used in the equation to protect aesthetic quality
Page 6 of 8

Permit No.NC0088811
6. The permit writer enters the most recent 2-3 years of effluent data for each pollutant of
concern. Data entered must have been taken within four and one-half years prior to the
date of the permit application(40 CFR 122.21). The RPA spreadsheet estimates the 95th
percentile upper concentration of each pollutant. The Predicted Max concentrations are
compared to the Total allowable concentrations to determine if a permit limit is
necessary. If the predicted max exceeds the acute or chronic Total allowable
concentrations, the discharge is considered to show reasonable potential to violate the
water quality standard, and a permit limit(Total allowable concentration) is included in
the permit in accordance with the U.S. EPA Technical Support Document for Water
Quality-Based Toxics Control published in 1991.
7. When appropriate,permit writers develop facility specific compliance schedules in
accordance with the EPA Headquarters Memo dated May 10, 2007 from James Hanlon to
Alexis Strauss on 40 CFR 122.47 Compliance Schedule Requirements.
8. The Total Chromium NC WQS was removed and replaced with trivalent chromium and
hexavalent chromium Water Quality Standards. As a cost savings measure, total
chromium data results may be used as a conservative surrogate in cases where there are
no analytical results based on chromium III or VI. In these cases, the projected maximum
concentration (95th%) for total chromium will be compared against water quality
standards for chromium III and chromium VI.
9. Effluent hardness sampling and instream hardness sampling, upstream of the discharge,
are inserted into all permits with facilities monitoring for hardness-dependent metals to
ensure the accuracy of the permit limits and to build a more robust hardness dataset.
10. Hardness and flow values used in the Reasonable Potential Analysis for this permit
included:
Parameter Value Comments (Data Source)
Average Effluent Hardness (mg/L)
[Total as, CaCO3 or(Ca+Mg)]
Average Upstream Hardness
(mg/L)
[Total as, CaCO3 or(Ca+Mg)]
7Q10 summer(cfs)
1 Q 10 (cfs)
Permitted Flow(MGD) 0.450 MGD Outfall 001 (per permit)
Page 7 of 8

Permit No. NC0088811
PROPOSED SCHEDULE FOR PERMIT ISSUANCE
Draft Permit to Public Notice: June 10, 2020 (estimate)
Permit Scheduled to Issue: August 30, 2020 (estimate)
Effective Date: October 1, 2020 (estimate)
NPDES DIVISION CONTACT
If you have questions regarding any of the above information or on the attached permit, please contact
Joe R. Corporon P.G via email [[e-mail]].
NAME: x DATE: 25AUG2020
Page 8 of 8

ROY COOPER
a. 'r `_#STATE)
G(rvt'rri g
MICHAEL S.REGANti w.,.• ' I.
SecretaryNr 4.....40.�
LINDA CULPEPPER NORTH CAROLINA
Director Environmental Quality
December 03, 2019
Pharmaceutical Produce Development, LLC.
Attn: Mark Armstrong, Facility Supervisor
929 N Front St
Wilmington, NC 28401
Subject: Permit Renewal
Application No. NC0088811
PPD Groundwater Remediation Site
New Hanover County
Dear Applicant:
The Water Quality Permitting Section acknowledges the November 26, 2019 receipt of your permit renewal application
and supporting documentation. Your application will be assigned to a permit writer within the Section's NPDES WW
permitting branch. Per G.S. 150E-3 your current permit does not expire until permit decision on the application is made.
Continuation of the current permit is contingent on timely and sufficient application for renewal of the current permit. The
permit writer will contact you if additional information is required to complete your permit renewal. Please respond in a
timely manner to requests for additional information necessary to allow a complete review of the application and renewal
of the permit.
Information regarding the status of your renewal application can be found online using the Department of Environmental
Quality's Environmental Application Tracker at:
https://deq.nc.gov/permits-regulations/permit-guidance/environmental-application-tracker
If you have any additional questions about the permit, please contact the primary reviewer of the application using the
links available within the Application Tracker.
Sincerely
Xit0/10 lot •'EaA
Wren Thedford
Administrative Assistant
Water Quality Permitting Section
ec: WQPS Laserfiche File w/application
NorthCaro r D_partnert:fErvronments,Qieatty I D+vs+o n ofWaterRe .rres
Q 1ti' m ngton Reg era Dff x I127 CsrdhnaI Dave Extenstsn I W In ngton,North Caro r.s 2340E
910-796-7215

•
EPA Identification Number NPDES Permit Number Facility Name Form Approved 03/05/19
110043162485 NC0088811 Pharmaceutical Product OMB No.2040-0004
Form U.S.Environmental Protection Agency
1 — EPA Application for NPDES Permit to Discharge Wastewater
NPDES GENERAL INFORMATION
SECTION 1.ACTIVITIES REQUIRING AN NPDES PERMIT(40 CFR 122.21(f)and(f)(1))
1.1 Applicants Not Required to Submit Form 1
Is the facility a new or existing publicly owned Is the facility a new or existing treatment works
1.1.1 1
treatment works? 1. .2 treating domestic sewage?
If yes, STOP. Do NOT complete �✓ No If yes,STOP. Do NOT ✓� No
Form 1.Complete Form 2A. complete Form 1.Complete
Form 2S.
1.2 Applicants Required to Submit Form 1
1.2.1 Is the facility a concentrated animal feeding 1.2.2 Is the facility an existing manufacturing.
f`. operation or a concentrated aquatic animal commercial, mining,or silvicultural facility that is
n production facility? currently discharging process wastewater?
oYes 4Complete Form 1 ❑✓ No ✓� Yes 4 Complete Form No
o and Form 2B. 1 and Form 2C.
0 1.2.3 Is the facility a new manufacturing,commercial, 1.2.4 Is the facility a new or existing manufacturing,
mining,or silvicultural facility that has not yet commercial,mining,or silvicultural facility that
commenced to discharge? discharges only nonprocess wastewater?
Yes 4 Complete Form 1 ✓D No ❑ Yes 4 Complete Form No
o' and Form 2D. 1 and Form 2E.
1.2.5 Is the facility a new or existing facility whose
' discharge is composed entirely of stormwater
associated with industrial activity or whose
discharge is composed of both stormwater and RECEIVED
non-stormwater?
El Yes 4 Complete Form 1 ❑✓ No NOV 2 6 2019
and Form 2F
unless exempted by NCDEQIDWRINPDES
40 CFR
122.26(b)(14)(x)or
b 15 .
SECTION 2.NAME,MAILING ADDRESS,AND LOCATION(40 CFR 122.21(f)(2))
2.1 Facility Name
Pharmaceutical Product Development,LLC. Ground Water Remediation Plant
O 2.2 EPA Identification Number
O 110043162485
2.3 Facility Contact
Name(first and last) Title Phone number
Mark Armstrong Supervisor Facilities and Real Estate [phone]
Email address
[e-mail]
• 2.4 Facility Mailing Address
Street or P.O.box
929 North Front Street
City or town State ZIP code
Wilmington North Carolina 28401
EPA Form 3510-1(revised 3-19) Page 1

EPA Identification Number NPDES Permit Number Facility Name Form Approved 03/05/19
110043162485 NC0088811 Pharmaceutical Product OMB No.2040-0004
6 F 2.5 Facility Location
. .s Street,route number,or other specific identifier
Q 0 929 North Front Street
rn
c o County name County code(if known)
New Hanover not known
a 3 City or town State ZIP code
z R Wilmington North Carolina 28401
SECTION 3.SIC AND NAICS CODES(40 CFR 122.21(f)(3))
3.1 SIC Code(s) Description(optional)
87319902 Medical research,commercial
en
a)
0
0
U
v7
U
3.2 NAICS Code(s) Description(optional)
v541715 Research and Development in the Physical,Engineering,and Life Sciences(except
N
SECTION 4.OPERATOR INFORMATION(40 CFR 122.21(f)(4))
4.1 Name of Operator
Pharmaceutical Product Development,Inc.
0 4.2 Is the name you listed in Item 4.1 also the owner?
❑✓ Yes ❑ No
—
4.3 Operator Status
❑ Public—federal ❑ Public—state ❑ Other public(specify)
0 ❑✓ Private D Other(specify)
4.4 Phone Number of Operator
[phone]
= 4.5 Operator Address
Street or P.O. Box
E 0 929 North Front Street
o 2
.= City or town State ZIP code
w o Wilmington North Carolina 28401
ru
0_ Email address of operator
[e-mail]
SECTION 5.INDIAN LAND(40 CFR 122.21(f)(5))
a -0 5.1 Is the facility located on Indian Land?
la c J ❑Yes ❑✓ No
EPA Form 3510-1(revised 3-19) Page 2

EPA Identification Number NPDES Permit Number Facility Name Form Approved 03/05/19
110043162485 NC0088811 Pharmaceutical Product OMB No.2040-0004
SECTION 6.EXISTING ENVIRONMENTAL PERMITS(40 CFR 122.21(f)(6))
6 1 Existing Environmental Permits(check all that apply and print or type the corresponding permit number for each)
v m NPDES(discharges to surface ❑ RCRA(hazardous wastes) El UIC(underground injection of
o water) fluids)
2 `n NC0088811
w a ❑ PSD(air emissions) ❑ Nonattainment program(CM) 0 NESHAPs(CM)
a)
❑ Ocean dumping(MPRSA) ❑ Dredge or fill(CWA Section 404) 0 Other(specify)
SECTION 7.MAP(40 CFR 122.21(f)(7))
7.1 Have you attached a topographic map containing all required information to this application?(See instructions for
0 specific requirements.)
✓❑Yes ❑No ❑ CAFO—Not Applicable(See requirements in Form 2B.)
SECTION 8.NATURE OF BUSINESS(40 CFR 122.21(f)(8))
8.1 Describe the nature of your business.
Pharmaceutical Product Development,LLC is a global contract research organization providing comprehensive,
integrated drug development,laboratory and lifecycle management services.
cu
U)
0
Co
i z
SECTION 9.COOLING WATER INTAKE STRUCTURES(40 CFR 122.21(f)(9))
9.1 Does your facility use cooling water?
❑ Yes ElNo 4 SKIP to Item 10.1.
i ..?„ 9.2 Identify the source of cooling water.(Note that facilities that use a cooling water intake structure as described at
, 40 CFR 125,Subparts I and J may have additional application requirements at 40 CFR 122.21(r).Consult with your
o Y NPDES permitting authority to determine what specific information needs to be submitted and when.)
o ,�
U
SECTION 10.VARIANCE REQUESTS(40 CFR 122.21(f)(10))
10.1 Do you intend to request or renew one or more of the variances authorized at 40 CFR 122.21(m)?(Check all that
apply. Consult with your NPDES permitting authority to determine what information needs to be submitted and
when.)
d ❑ Fundamentally different factors(CWA ❑ Water quality related effluent limitations(CWA Section
e Section 301(n)) 302(b)(2))
c ❑ Non-conventional pollutants(CWA ❑ Thermal discharges(CWA Section 316(a))
I >
Section 301(c)and(g))
❑✓ Not applicable
EPA Form 3510-1(revised 3-19) Page 3

EPA Identification Number NPDES Permit Number Facility Name Form Approved 03/05/19
110043162485 NC0088811 Pharmaceutical Product OMB No.2040-0004
SECTION 11.CHECKLIST AND CERTIFICATION STATEMENT(40 CFR 122.22(a)and(d))
11.1 In Column 1 below, mark the sections of Form 1 that you have completed and are submitting with your application.
For each section,specify in Column 2 any attachments that you are enclosing to alert the permitting authority.Note
that not all applicants are required to provide attachments.
Column 1 Column 2
✓❑ Section 1:Activities Requiring an NPDES Permit ❑ w/attachments
✓❑ Section 2: Name, Mailing Address,and Location El w/attachments
✓❑ Section 3:SIC Codes ❑ wl attachments
✓❑ Section 4:Operator Information ❑ w/attachments
O Section 5: Indian Land ❑ w/attachments
✓❑ Section 6: Existing Environmental Permits ❑ wl attachments
dEl Section 7:Map watpopographic 1-1 wl additional attachments
c 0 Section 8:Nature of Business ❑ wl attachments
✓❑ Section 9:Cooling Water Intake Structures ❑ w/attachments
-o
❑✓ Section 10:Variance Requests El w/attachments
D Section 11:Checklist and Certification Statement ❑ wl attachments
-
11.2 Certification Statement
U
/certify under penalty of law that this document and all attachments were prepared under my direction or supervision
in accordance with a system designed to assure that qualified personnel properly gather and evaluate the
information submitted. Based on my inquiry of the person or persons who manage the system, or those persons
directly responsible for gathering the information,the information submitted is,to the best of my knowledge and
belief,true,accurate,and complete. I am aware that there are significant penalties for submitting false information,
including the possibility of fine and imprisonment for knowing violations.
Name(print or type first and last name) Official title
Mark Armstrong Supervisor Facilities and Real Estate
Signature
� �/ Date signed
/'f l Ct/2.fPi.�`/2yYLdt1.67- 11/20/2019
EPA Form 3510-1(revised 3-19) Page 4

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ttito
USGS Quad: K27NW Wilmington, NC
Outfall Facility Facility
Latitude: 34° 14'35" N 34° 14'45.2" N
Longitude:77°57'4"W 77°56'56.3"W Location "
Stream Class: SC, Sw
Subbasin:03 06 23 Pharmaceutical Product Development,Inc.
NC0088811
Receiving Stream: Northeast Cape Fear RiverNew Hanover County
North

f
EPA Identification Number NPDES Permit Number Facility Name Form Approved 03/05/19
110043162485 NC0088811 Pharmaceutical Product OMB No.2040-0004
Form U.S.Environmental Protection Agency
2C "EPA Application for NPDES Permit to Discharge Wastewater
NPDES EXISTING MANUFACTURING,COMMERCIAL,MINING,AND SILVICULTURE OPERATIONS
SECTION 1.OUTFALL LOCATION(40 CFR 122.21(g)(1))
1.1 Provide information on each of the facility's outfalls in the table below.
g Numbelr Receiving Water Name Latitude Longitude
U
001 Northeast Cape Fear 34° 14' 35" N 77° 57' 4' W
°
O
SECTION 2.LINE DRAWING(40 CFR 122.21(g)(2))
p, 2.1 Have you attached a line drawing to this application that shows the water flow through your facility with a water
3 balance?(See instructions for drawing requirements. See Exhibit 2C-1 at end of instructions for example.)
J
o ❑✓ Yes ❑ No
SECTION 3.AVERAGE FLOWS AND TREATMENT(40 CFR 122.21(g)(3))
3.1 For each outfall identified under Item 1.1,provide average flow and treatment information.Add additional sheets if
necessary.
**Outfall Number** 001
Operations Contributing to Flow
Operation Average Flow
GROUNDWATER .029 mgd
c
E mgd
,3
mgd
cts mgd
Description Code from Final Disposal of Solid or
(include size,flow rate through each treatment unit, Table 2C-1 Liquid Wastes Other Than
., retention time,etc.) by Discharge
NA NA NA
RECEIVED
NOV 2 6 2019
NCOEQ/DWR/NPDES
EPA Form 3510-2C(Revised 3-19) Page 1

EPA Identification Number NPDES Permit Number Facility Name Form Approved 03/05/19
110043162485 NC0088811 Pharmaceutical Product OMB No.2040-0004
3.1 **Outfall Number**
cont. Operations Contributing to Flow
Operation Average Flow
NA NA mgd
mgd
mgd
mgd
Treatment Units
Description Code from Final Disposal of Solid or
(include size,flow rate through each treatment unit. Table 2C-1 Liquid Wastes Other Than
retention time,etc.) by Discharge
-0 NA NA NA
m
0
V I
a�
E
C)
a�
**Outfall Number**
Operations Contributing to Flow
0 Operation Average Flow
NA NA mgd
d
a' mgd
mgd
mgd
Treatment Units
Description Code from Final Disposal of Solid or
(include size,flow rate through each treatment unit, Table 2C-1 Liquid Wastes Other Than
retention time,etc.) by Discharge
NA NA NA
3.2 Are you applying for an NPDES permit to operate a privately owned treatment works?
❑✓ Yes ❑ No+ SKIP to Section 4.
e. 3.3 Have you attached a list that identifies each user of the treatment works?
❑ Yes ❑✓ No
EPA Form 3510-2C(Revised 3-19) Page 2

EPA Identification Number NPDES Permit Number Facility Name Form Approved 03/05/19
110043162485 NC0088811 Pharmaceutical Product OMB No.2040-0004
SECTION 4.INTERMITTENT FLOWS(40 CFR 122.21(g)(4))
4.1 Except for storm runoff,leaks,or spills,are any discharges described in Sections 1 and 3 intermittent or seasonal?
❑ Yes ❑✓ No 4 SKIP to Section 5.
4.2 Provide information on intermittent or seasonal flows for each applicable outfall.Attach additional pages.if necessary.
Outfall Operation Frequency Flow Rate
Number (list) Average Average Long-Term Maximum Duration
Days/Week Months/Year Average Daily
days/week months/year mgd mgd days
days/week months/year mgd mgd days
LL
days/week months/year mgd mgd days
days/week months/year mgd mgd days
c
days/week months/year mgd mgd days
days/week months/year mgd mgd days
days/week months/year mgd mgd days
days/week months/year mgd mgd days
days/week months/year mgd mgd days
SECTION 5.PRODUCTION t40 CFR 122.21(g)(5))
5.1 Do any effluent limitation guidelines(ELGs)promulgated by EPA under Section 304 of the CWA apply to your facility?
❑ Yes ❑✓ No 4 SKIP to Section 6.
5.2 Provide the following information on applicable ELGs.
w ELG Category ELG Subcategory Regulatory Citation
a
0-
5.3 Are any of the applicable ELGs expressed in terms of production(or other measure of operation)?
❑ Yes ❑ No 4 SKIP to Section 6.
0
5.4 Provide an actual measure of daily production expressed in terms and units of applicable ELGs.
Outfall Operation,Product,or Material Quantity per Day Unit of
-0 Number Measure
co
0
0
0
a`
EPA Form 3510-2C(Revised 3-19) Page 3

EPA Identification Number NPDES Permit Number Facility Name Form Approved 03/05/19
110043162485 NC0088811 Pharmaceutical Product OMB No.2040-0004
SECTION 6. IMPROVEMENTS(40 CFR 122.21(g)(6))
6.1 Are you presently required by any federal,state,or local authority to meet an implementation schedule for constructing,
upgrading,or operating wastewater treatment equipment or practices or any other environmental programs that could
affect the discharges described in this application?
❑ Yes ✓❑ No 4 SKIP to Item 6.3.
6.2 Briefly identify each applicable project in the table below.
a Affected Final Compliance Dates
Brief Identification and Description of Outfalls Source(s)of
Project (list outfall Discharge Required Projected
number)
E
C
In
l.2
a)
0
6.3 Have you attached sheets describing any additional water pollution control programs(or other environmental projects
that may affect your discharges)that you now have underway or planned?(optional item)
❑ Yes ❑ No ✓❑ Not applicable
SECTION 7.EFFLUENT AND INTAKE CHARACTERISTICS(40 CFR 122.21(g)(7))
See the instructions to determine the pollutants and parameters you are required to monitor and, in turn,the tables you must
complete.Not all applicants need to complete each table.
Table A.Conventional and Non-Conventional Pollutants
7.1 Are you requesting a waiver from your NPDES permitting authority for one or more of the Table A pollutants for any of
your outfalls?
❑ Yes ❑✓ No 4 SKIP to Item 7.3.
7.2 If yes, indicate the applicable outfalls below.Attach waiver request and other required information to the application.
Outfall Number Outfall Number Outfall Number
7.3 Have you completed monitoring for all Table A pollutants at each of your outfalls for which a waiver has not been
N requested and attached the results to this application package?
No;a waiver has been requested from my NPDES
R ✓❑ Yes ❑ permitting authority for all pollutants at all outfalls.
Table B.Toxic Metals,Cyanide,Total Phenols,and Organic Toxic Pollutants
R 7.4 Do any of the facility's processes that contribute wastewater fall into one or more of the primary industry categories
listed in Exhibit 2C-3?(See end of instructions for exhibit.)
❑ Yes ✓❑ No 4 SKIP to Item 7.8.
7.5 Have you checked"Testing Required"for all toxic metals,cyanide,and total phenols in Section 1 of Table B?
;, ❑ Yes ❑ No
7.6 List the applicable primary industry categories and check the boxes indicating the required GC/MS fraction(s)identified
in Exhibit 2C-3.
Required GC/MS Fraction(s)
Primary Industry Category (Check applicable boxes.)
❑Volatile 0 Acid 0 Base/Neutral 0 Pesticide
0 Volatile 0 Acid ❑Base/Neutral ❑ Pesticide
❑Volatile ❑Acid 0 Base/Neutral ❑Pesticide
EPA Form 3510-2C(Revised 3-19) Page 4

EPA Identification Number NPDES Permit Number Facility Name Form Approved 03/05/19
110043162485 NC0088811 Pharmaceutical Product OMB No.2040-0004
7.7 Have you checked"Testing Required"for all required pollutants in Sections 2 through 5 of Table B for each of the
GC/MS fractions checked in Item 7.6?
❑ Yes ❑ No
7.8 Have you checked"Believed Present"or"Believed Absent"for all pollutants listed in Sections 1 through 5 of Table B
where testing is not required?
❑✓ Yes ❑ No
7.9 Have you provided(1)quantitative data for those Section 1,Table B,pollutants for which you have indicated testing is
required or(2)quantitative data or other required information for those Section 1,Table B,pollutants that you have
indicated are"Believed Present"in your discharge?
p Yes ❑ No
7.10 Does the applicant qualify for a small business exemption under the criteria specified in the instructions?
❑ Yes 4 Note that you qualify at the top of Table B, ❑✓ No
- then SKIP to Item 7.12.
• 7.11 Have you provided(1)quantitative data for those Sections 2 through 5,Table B,pollutants for which you have
o determined testing is required or(2)quantitative data or an explanation for those Sections 2 through 5,Table B,
y pollutants you have indicated are"Believed Present"in your discharge?
✓❑ Yes ❑ No
v Table C.Certain Conventional and Non-Conventional Pollutants
P. 7.12 Have you indicated whether pollutants are"Believed Present"or"Believed Absent"for all pollutants listed on Table C
for all outfalls?
✓❑ Yes ❑ No
c 7.13 Have you completed Table C by providing(1)quantitative data for those pollutants that are limited either directly or
indirectly in an ELG and/or(2)quantitative data or an explanation for those pollutants for which you have indicated
;° "Believed Present"?
✓❑ Yes ❑ No
w Table D.Certain Hazardous Substances and Asbestos
7.14 Have you indicated whether pollutants are"Believed Present"or"Believed Absent"for all pollutants listed in Table D for
all outfalls?
✓❑ Yes ❑ No
7.15 Have you completed Table D by(1)describing the reasons the applicable pollutants are expected to be discharged
and(2)by providing quantitative data,if available?
❑✓ Yes ❑ No
Table E.2,3,7,8-Tetrachlorodibenzo-p-Dioxin(2,3,7,8-TCDD)
7.16 Does the facility use or manufacture one or more of the 2,3,7,8-TCDD congeners listed in the instructions,or do you
know or have reason to believe that TCDD is or may be present in the effluent?
❑ Yes 4 Complete Table E. ElNo 4 SKIP to Section 8.
7.17 Have you completed Table E by reporting qualitative data for TCDD?
❑ Yes ❑ No
SECTION 8.USED OR MANUFACTURED TOXICS(40 CFR 122.21(g)(9))
8.1 Is any pollutant listed in Table B a substance or a component of a substance used or manufactured at your facility as
an intermediate or final product or byproduct?
❑ Yes ❑✓ No 4 SKIP to Section 9.
0
4,2 8.2 List the pollutants below.
c .
1. 4. 7.
2. 5. 8.
� I
3. 6. 9.
EPA Form 3510-2C(Revised 3-19) Page 5

EPA Identification Number NPDES Permit Number Facility Name Form Approved 03/05/19
110043162485 NC0088811 Pharmaceutical Product OMB No.2040-0004
SECTION 9.BIOLOGICAL TOXICITY TESTS(40 CFR 122.21(g)(11))
9.1 Do you have any knowledge or reason to believe that any biological test for acute or chronic toxicity has been made
within the last three years on(1)any of your discharges or(2)on a receiving water in relation to your discharge?
❑ Yes ✓❑ No 4 SKIP to Section 10.
9.2 Identify the tests and their purposes below.
Submitted to NPDES
Test(s) Purpose of Test(s) Date Submitted
Authority?x Permitting
0
ElYes ElNo
0
0
m ❑ Yes ❑ No
❑ Yes ❑ No
SECTION 10.CONTRACT ANALYSES(40 CFR 122.21(g)(12))
10.1 Were any of the analyses reported in Section 7 performed by a contract laboratory or consulting firm?
❑✓ Yes ❑ No 4 SKIP to Section 11.
10.2 Provide information for each contract laboratory or consulting firm below.
Laboratory Number 1 Laboratory Number 2 Laboratory Number 3
Name of laboratory/firm Pace Analytical,LLC
;, Laboratory addressTo 9800 Kincey Ave,suite 100,
Q
Huntersville,NC 28078
to
to
Phone number
[phone]
Pollutant(s)analyzed
SECTION 11.ADDITIONAL INFORMATION(40 CFR 122.21(g)(13))
11.1 Has the NPDES permitting authority requested additional information?
o ❑ Yes ✓❑ No 4 SKIP to Section 12.
0
m 11.2 List the information requested and attach it to this application.
L
1. 4.
m
c
0
-02. 5.
3. 6.
EPA Form 3510-2C(Revised 3-19) Page 6

EPA Identification Number NPDES Permit Number Facility Name Form Approved 03/05/19
110043162485 NC0088811 Pharmaceutical Product OMB No.2040-0004
SECTION 12.CHECKLIST AND CERTIFICATION STATEMENT(40 CFR 122.22(a)and(d))
12.1 In Column 1 below, mark the sections of Form 2C that you have completed and are submitting with your application.
For each section,specify in Column 2 any attachments that you are enclosing to alert the permitting authority.Note
that not all applicants are required to complete all sections or provide attachments.
Column 1 Column 2
0 Section 1:Outfall Location ✓❑ w/attachments
✓❑ Section 2:Line Drawing ✓❑ w/line drawing ❑ w/additional attachments
Section 3:Average Flows and w/list of each user of
Treatment ❑ w/attachments Elprivately owned treatment
works
❑✓ Section 4:Intermittent Flows ❑ w/attachments
✓❑ Section 5: Production ❑ w/attachments
w/optional additional
❑✓ Section 6: Improvements ❑ w/attachments ❑ sheets describing any
additional pollution control
plans
❑ w/request for a waiver and ❑ w/explanation for identical
supporting information outfalls
w/small business exemption w/other attachments
❑ request ❑
✓❑ Section 7:Effluent and Intake ✓❑ w/Table A 0 w/Table B
Characteristics
0
C ✓❑ w/Table C ❑ w/Table D
47
El w/Table E ❑ w/analytical results as an
c� attachment
C ✓❑ Section 8:Used or Manufactured ❑ w/attachments
N Toxics
❑ Section 9: Biological Toxicity ❑ w/attachments
Tests
U
O Section 10:Contract Analyses ❑ w/attachments
✓❑ Section 11:Additional Information 0 w/attachments
✓❑ Section 12:Checklist and ❑ w/attachments
Certification Statement
12.2 Certification Statement
I certify under penalty of law that this document and all attachments were prepared under my direction or supervision in
accordance with a system designed to assure that qualified personnel properly gather and evaluate the information
submitted. Based on my inquiry of the person or persons who manage the system,or those persons directly
responsible for gathering the information,the information submitted is, to the best of my knowledge and belief,true,
accurate,and complete.I am aware that there are significant penalties for submitting false information,including the
possibility of fine and imprisonment for knowing violations.
Name(print or type first and last name) Official title
Mark Armstrong Supervisor Facilities and Real Estate
Signature Date signed
Na-e,A2,mdtze
11/20/2019
EPA FoPm 3510-2C(Revised 3-19) Page 7

This page intentionally left blank.

EPA Identification Number NPDES Permit Number Facility Name Outfall Number Form Approved 03/05/19 .
110043162485 NC0088811 Pharmaceutical Product 001 OMB No.2040 0004
TABLE A.CONVENTIONAL AND NON CONVENTIONAL POLLUTANTS(40 CFR 122.21(g)(7)(iii))1
Effluent Intake
Waiver (Optional)
licable
Pollutant Requested Units Maximum Maximum Long-Term
(ifapueste) (specify) Daily Monthly Average Daily Number of Long-Term Number of
Discharge Discharge Discharge Analyses Average Value Analyses
(required) (if available) (if available)
0 Check here if you have applied to your NPDES permitting authority for a waiver for all of the pollutants listed on this table for the noted outfall.
Biochemical oxygen demand Concentration mg/L 74.2 74.2 10
1' ❑(BODs) Mass
Chemical oxygen demand Concentration mg/L 57 57 10
2' ❑
(COD) Mass
Concentration - - - -
3. Total organic carbon(TOC) ❑
Mass
Concentration - - - -
4. Total suspended solids(TSS) ❑ •
Mass
Concentration mg/L 69.3 69.3 10
5. Ammonia(as N) 0
Mass
6. Flow ❑ Rate gallons 18408 499550 13495 18825
Temperature(winter) 0 °C °C 13.1 13.1
7.
Temperature(summer) 0 °C °C 26.7 26.7
pH(minimum) 0 Standard units S.U. 7.08 7.08
8.
pH(maximum) 0 Standard units s.u. 8.67 8.67
1 Sampling shall be conducted according to sufficiently sensitive test procedures(i.e.,methods)approved under 40 CFR 136 for the analysis of pollutants or pollutant parameters or
required under 40 CFR chapter I,subchapter N or 0.See instructions and 40 CFR 122.21(e)(3).
EPA Form 3510-2C(Revised 3-19) Page 9

This page intentionally left blank.

EPA Identification Number NPDES Permit Number Facility Name Outfall Number Form Approved 03/05/19
110043162485 NC0088811 Pharmaceutical Product 001 OMB No.2040-0004
4:111N iIeii'14191:114/LII114i0111111�:1= ilULVI�I�aeflZR41011[40111LII _Vaniati AiPk�f'�if s
Presence or Absence
(check one) Effluent Intake
(optional)
Number
Pollutant/Parameter Testing Units Long-Term
(and CAS Number,if available) Required Believed Believed (specify) Maximum Maximum Average Number
Daily of
Long
Present Absent Daily Monthly Term of
Analyses
Discharge Discharge Discharge Analyses Average
(required) (if available) Value
(if available)
❑ Check here if you qualify as a small business per the instructions to Form 2C and,therefore,do not need to submit quantitative data for any of the organic toxic pollutants in Sections
2 through 5 of this table.Note,however,that you must still indicate in the appropriate column of this table if you believe any of the pollutants listed are present in your discharge.
Section 1.Toxic Metals,Cyanide,and Total Phenols
Antimony,total Concentration
1.1 0 El
(7440-36-0) Mass
Arsenic,total Concentration mg/L .0422 .0422 59
1.2 El El
(7440-38-2) Mass
1.3 Beryllium,total ❑ Concentration
El 0
(7440-41-7) Mass
1.4 Cadmium,total 0 Concentration
0 El
(7440-43-9) Mass
Chromium,total0 Concentration mg/L .0733 .0733 59
1.5 0 El
(7440-47-3) Mass _
1.6 Copper,total Concentration mg/L .0597 .0597 59
El El 0
(7440-50-8) Mass _
1.7 Lead,total Concentration
0 El El
(7439-92-1) Mass
1.8 Mercury,total � ❑ Concentration
(7439-97-6) Mass
Nickel,total Concentration mg/L .021 .021 10
1'9 0 El
(7440-02-0) Mass
Selenium,total Concentration
1.10 (7782-49-2) Mass
Silver,total Concentration
1.11 0 0
(7440-22-4) Mass
EPA Form 3510-2C(Revised 3-19) Page 11

EPA Identification Number NPDES Permit Number Facility Name Outfall Number Form Approved 03/05/19
110043162485 NC0088811 Pharmaceutical Product 001 OMB No.2040-0004
1:111•?3 el!it4l_111t671_MBI*01Ell110az Z[el Fc-LlZ111,1;4-L1ZlleilteK4MIit 111110:11UlloU A Fkill
Presence or Absence Intake
(check one) Effluent (optional)
PollutantiParameter Testing Units Long-Term
(and CAS Number,if available) Required Believed Believed (specify) Maximum Maximum Average Number Long Number
Present Absent Daily Monthly Daily of Term of
Discharge Discharge Discharge Analyses Average Analyses
(required) (if available) Value
(if available) _ _
Thallium,total Concentration
1.12 (7440 28 0) El
El
Mass _
1.13 Zinc,total ❑ Concentration mg/L 0.16 0.16 59
D El(7440-66-6) Mass
1.14 Cyanide,total ✓❑ Concentration `
(57-12-5) Mass
------------
1.15 Phenols,total ❑ Concentration
Mass
Section 2.Organic Toxic Pollutants(GC/MS Fraction—Volatile Compounds)
21 Acrolein ❑ Concentration
(107-02-8) Mass
Acrylonitrile Concentration
2.2 (107-13-1) ❑ �
Mass
2.3 Benzene ElConcentration
0 El
(71-43-2) Mass
Bromoform Concentration
2.4 (75-25-2) ❑ ❑ ✓❑ Mass
Carbon tetrachloride 0 Concentration
2.5 (56-23-5) Mass
Chlorobenzene 1=1 Concentration
2.6 (108-90-7) Mass
Chlorodibromomethane 1=1 Concentration
2.7 (124-48-1) Mass
Chloroethane Concentration
2.8 (75-00-3) � �
Mass
EPA Form 3510-2C(Revised 3-19) Page 12

EPA Identification Number NPDES Permit Number Facility Name Outfall Number Form Approved 03/05/19
110043162485 NC0088811 Pharmaceutical Product 001 OMB No.2040-0004
alliteXffeliT14111IC-ING1 11i]40111001: [ I-MI:IibliteLC11.010:1101:1•111Mi lZ'TIMi!I.l ;AVM(. v 1
Presence or Absence Intake
(check one) Effluent (optional)
Pollutant/Parameter Testing Units Long Term
(and CAS Number,if available) Required Believed Believed (specify) Maximum Maximum Average Number Long Number
Present Absent Daily Monthly
Discharge Daily of Term of
ifavailablle Discharge Analyses AValueverage Analyses
(required) )
(if )
2.9 2-chloroethylvinyl ether ❑✓ Concentration
(110-75-8) Mass
Concentration
2.10 Chloroform(67-66-3) ❑ ❑ 0 Mass
•
2.11 Dichlorobromomethane ❑ 0 Concentration
(75-27-4) Mass
2.12 1,1-dichloroethane El 0 ❑ Concentration
(75-34-3) Mass
2.13 1,2-dichloroethane El ElElConcentration
(107-06-2) Mass
2.14 1,1-dichloroethylene 0 0 ❑ Concentration
(75-35-4) Mass
2.15 12-dichloropropane 0 ElElConcentration
(78-87-5) Mass
2.16 1,3-dichloropropylene 0 ❑ Concentration
(542-75-6)
Mass
Ethylbenzene Concentration
2.17 0 El El
(100-41-4) Mass •
2.18 Methyl bromide ID ElConcentration
(74-83-9) Mass
219 Methyl chloride ❑ � Concentration
(74-87-3) Mass
2.20 Methylene chloride El 0 ❑ Concentration
(75-09-2) Mass
2.21 1,1,2,2-tetrachloroethane 0 Concentration
0 El
(79-34-5) Mass
EPA Form 3510-2C(Revised 3-19) Page 13

EPA Identification Number NPDES Permit Number Facility Name Outfall Number Form Approved 03/05/19
110043162485 NC0088811 Pharmaceutical Product 001 OMB No.2040-0004
4AODNIL'd4itl4:1aY_1NIol*001U3:Im Lel!MI 2INUa4_VBrise:1DI gel WIEli'l lfilig:61114
Presence or Absence Intake
(check one) Effluent (optional)
Pollutant/Parameter Testing Units Long Term
(and CAS Number,if available) Required Believed Believed (specify) Maximum Maximum Average Number Long Number
Present Absent Daily Monthly Daily of Term of
Discharge Discharge Dotischarge Analyses Average
Value Analyses
(required) (if available)
available)
2.22 Tetrachloroethylene ❑ ❑ Concentration
(127-18-4) Mass
2.23 Toluene � Concentration
El El(108-88-3) Mass
2.24 1,2-trans-dichloroethylene ❑ 0Concentration
(156-60-5) Mass
2.25 1,1,1-trichloroethane 0 ❑ ❑ Concentration
(71-55-6) Mass
2.26 1,1,2-trichloroethane ❑ ❑ 0 Concentration
(79-00-5) Mass
2.27 Trichloroethylene 0 0Concentration
(79-01-6) Mass
2.28 Vinyl chloride El Concentration
(75-01-4) Mass
Section 3.Organic Toxic Pollutants(GC/MS Fraction—Acid Compounds)
3.1 2-chlorophenol Concentration
(95-57-8) Mass
2,4-dichlorophenol Concentration
3.2 0 El
(120-83-2) Mass
2,4-dimethylphenol Concentration
3.3 0 El El
(105-67-9) Mass
4,6-dinitro-o-cresol Concentration
3.4 (534-52-1) Mass
3.5 2,4-dinitrophenol ❑ ❑ Concentration
(51-28-5) Mass
EPA Form 3510-2C(Revised 3-19) Page 14

EPA Identification Number NPDES Permit Number Facility Name Outfall Number Form Approved 03/05/19
110043162485 NC0088811 Pharmaceutical Product 001 OMB No.2040-0004
Presence or Absence
(check one) Effluent Intake
(optional)
PollutantlParameter Testing Units Long-Term
(and CAS Number,if available) Required Believed Believed (specify) Maximum Maximum Average Number Long- Number
Present Absent Daily Monthly Daily of Term of
Discharge Discharge Discharg Analyses Average Analyses
(required) (if available) Value
(if available)e
3.6 2-nitrophenol Concentration
(88-75-5) Mass
4-nitrophenol Concentration
3.7 (100 02 7) ❑ ❑ El
Mass
3.8 p-chloro-m-cresol Concentration
(59-50-7) ✓ Mass
3.9 Pentachlorophenol 0 Concentration
(87-86-5) Mass
Phenol Concentration
3.10 (108-95-2) 0 0 Mass
3.11 2 4,6-trichlorophenol Concentration
(88-05-2) Mass
Section 4.Organic Toxic Pollutants(GC/MS Fraction—Base/Neutral Compounds)
4.1 Acenaphthene ❑ a Concentration
(83-32-9) Mass
Acenaphthylene Concentration
4.2 (208-96-8) Mass
Anthracene Concentration
4.3 0 El(120-12-7) El
Mass
Benzidine Concentration
4.4 0 El El
(92-87-5) Mass
Benzo(a)anthracene Concentration
4.5 (56-55-3) Mass
4.6 Benzo(a)pyrene El 0 ElConcentration
(50-32-8) Mass
EPA Form 3510-2C(Revised 3-19) Page 15

EPA Identification Number NPDES Permit Number Facility Name Outfall Number Form Approved 03/05/19
110043162485 NC0O88811 Pharmaceutical Product 001 OMB No.2040-0004
Presence or Absence
(check one) Effluent Intake
(optional)
PollutantiParameter Testing Units Long Term
(and CAS Number,if available) Required Believed Believed (specify) Maximum Maximum Average Number Long Number
Present Absent Daily Monthly Daily of Term of
Discharge Discharge Discharge Analyses Average Analyses
(required) (if available) Value
(if available)
4.7 3,4-benzofluoranthene ❑ Concentration
El 0(205-99-2) Mass
4.8 Benzo(ghi)perylene ❑ Concentration
El 0
(191-24-2) Mass
4.9 Benzo(k)fluoranthene ❑ Concentration
(207-08-9) Mass
Bis(2-chloroethoxy)methane 0 Concentration
4.10 0 El
(111-91-1) Mass
Bis(2-chloroethyl)ether 0 Concentration
4.11 (111 44 4) ❑ 0
Mass
Bis(2-chloroisopropyl)ether 0 Concentration
4.12 El 0
(102-80-1) Mass
Bis(2-ethylhexyl)phthalate 0 Concentration
4.13 (117-81-7) ❑ ❑
Mass
4-bromophenyl phenyl ether 0 Concentration
4.14 (101-55-3) Mass
4.15 Butyl benzyl phthalate El Concentration
(85-68-7) Mass
4.16 2-chloronaphthalene ❑ ❑ Concentration
(91-58-7) Mass
4-chlorophenyl phenyl ether 0 Concentration
4.17 (7005 72 3) ❑ ❑
Mass
Chrysene 0 Concentration
4.18 (218-01-9) Mass
4.19 Dibenzo(a,h)anthracene El0 Concentration
El
(53-70-3) Mass
Page 16
EPA Form 3510-2C(Revised 3-19)

EPA Identification Number NPDES Permit Number Facility Name Outfall Number Form Approved 03/05/19
110043162485 NC0088811 Pharmaceutical Product 001 OMB No.2040-0004
1:1Iii eil'iI40CIR_:I[il*ItelElmoi:zmicir1ZUICTITI21[91 ON Isig•111 NI LIZ'1%-nfiI Intal
Presence or Absence Intake
(check one) Effluent (optional)
Pollutant/Parameter Testing Units Long Term
(and CAS Number,if available) Required Believed Believed (specify) Maximum Maximum Average Number Lang Number
Present Absent Daily Monthly Daily of Term of
Dischargee
i d) (if available) Discharge Analyses AverageValue Analyses
(if available)
4.20 12-dichlorobenzene � � Concentration
(95-50-1) Mass
1,3-dichlorobenzene Concentration
4.21 (541-73-1)
Mass
4.22 1,4-dichlorobenzene � Concentration
El
(106-46-7) Mass
4.23 3,3-dichlorobenzidine � 0 Concentration
(91-94-1) Mass
4.24 Diethyl phthalate © Concentration
0 El
(84-66-2) Mass
4.25 Dimethyl phthalate 0 0 Concentration
(131-11-3) Mass
4.26 Di-n-butyl phthalate 0 © Concentration
(84-74-2) Mass
2,4-dinitrotoluene Concentration
4.27 0 El
(121-14-2) © Mass
2,6-dinitrotoluene Concentration
4.28 (606-20-2) Mass
Di-n-octyl phthalate Concentration
4.29 (117-84-0) Mass
4.30 1,2-Diphenylhydrazine � 0 Concentration
(as azobenzene)(122-66-7) Mass
Fluoranthene 0 Concentration
4.31 (206-44-0) Mass
4.32 Fluorene 0 Concentration
(86-73-7) Mass
EPA Form 3510-2C(Revised 3-19) Page 17

EPA Identification Number NPDES Permit Number Facility Name Outfall Number Form Approved 03/05/19
110043162485 NC0088811 Pharmaceutical Product 001 OMB No.2040-0004
TABLE B.TOXIC METALS,CYANIDE,TOTAL PHENOLS,AND ORGANIC TOXIC POLLUTANTS(40 CFR 122.21(g)(7)(v))1
Presence or Absence Intake
(check one) Effluent (optional)
Pollutant/Parameter Testing Units Long-Term
(and CAS Number,if available) Required Believed Believed (specify) Maximum Maximum Average Number Long- Number
Present Absent Daily Monthly Daily of Term of
Discharge Discharge Discharge Analyses Average Analyses
(required) (if available) Value
(if available)
4.33 Hexachlorobenzene ❑ ❑ 0 Concentration
(118-74-1) Mass
4.34 Hexachlorobutadiene ❑ Concentration
(87-68-3) Mass
4.35 Hexachlorocyclopentadiene 0 Concentration
El 0
(77-47-4) Mass
4.36 Hexachloroethane ❑ Concentration
(67-72-1) Mass
Indeno(1,2,3-cd)pyrene Concentration
4.37 (193-39-5) Mass
4.38 Isophorone 0Concentration
0 0
(78-59-1) Mass
4.39 Naphthalene 0 0 Concentration
(91-20-3) Mass
4.40 Nitrobenzene 0Concentration
0 El
(98-95-3) Mass
4.41 N-nitrosodimethylamine El Concentration
El
(62-75-9) Mass
N-nitrosodi-n-propylamine 0 Concentration
4.42 El 0
(621-64-7) Mass
4.43 N-nitrosodiphenylamine 0Concentration
0 El
(86-30-6) Mass
4.44 Phenanthrene 0 0 Concentration
(85-01-8) Mass
Pyrene Concentration
4.45 El 0 0 Mass
EPA Form 3510-2C(Revised 3-19) Page 18

EPA Identification Number NPDES Permit Number Facility Name Outfall Number Form Approved 03/05/19
110043162485 NC0088811 Pharmaceutical Product 001 OMB No.2040-0004
Presence or Absence Intake
(check one) Effluent (optional)
Pollutant/Parameter Testing Units Long-Term
(and CAS Number,if available) Required Believed Believed (specify) Maximum Maximum Average Number Long Number
Present Absent Daily Monthly Daily of Term of
Discharge Discharge Discharge Analyses Average Analyses
(required) (if available) (if available) Value
1,2,4-trichlorobenzene Concentration
4.46 (120-82-1) ❑ ❑ ✓
Mass
Section 5.Organic Toxic Pollutants(GC/MS Fraction—Pesticides)
5.1 Aldrin ❑ ❑ ❑ Concentration
(309-00-2) Mass
a-BHC Concentration
5.2 (319-84-6) ❑ 0 Mass
R-BHC Concentration
5.3 (319-85-7) ❑ 0 Mass
y-BHC Concentration
5.4 (58 89 9) ❑ ❑ 0Mass
6-BHC Concentration
5.5 (319-86-8) 0 0 Mass
5.6 Chlordane ❑ ❑ Concentration
0
(57-74-9) Mass
5.7 4,4'-DDT El ❑ ❑ Concentration
(50-29-3) Mass
5.8 4,4'-DDE ❑ ❑ Q Concentration
(72-55-9) Mass
5.9 4,4'-DDD El ❑ Concentration
0(72-54-8) Mass
5.10 Dieldrin ❑ ❑ ❑ Concentration
(60-57-1) Mass
5.11 a-endosulfan 0
0
0
Concentration
(115-29-7) Mass
EPA Form 3510-2C(Revised 3-19) Page 19

EPA Identification Number NPDES Permit Number Facility Name Outfall Number Form Approved 03/05/19
110043162485 NC0088811 Pharmaceutical Product 001 OMB No.2040-0004
TABLE B.TOXIC METALS,CYANIDE,TOTAL PHENOLS,AND ORGANIC TOXIC POLLUTANTS(40 CFR 122.21(g)(7)(v))l
Presence or Absence Intake
(check one) Effluent (optional)
Pollutant/Parameter Testing Units Long-Term
(and CAS Number,if available) Required Believed Believed (specify) Maximum Maximum Average Number Long Number
Daily Monthly Term
Present Absent Daily of of
Discharge Discharge Discharge Analyses Average Analyses
(required) (if available) Value
(if available)
0 R-endosulfan El 0 Concentration
5.12 (115-29-7) Mass
5.13 Endosulfan sulfate IDConcentration
0 ID
(1031-07-8) Mass
514 Endrin ❑ ❑ 0 Concentration
(72-20-8) Mass
5.15 Endrin aldehyde El D Concentration
(7421-93-4) Mass
5.16 Heptachlor � Concentration
(76-44-8) Mass
Heptachlor epoxide Concentration
5.17 (1024-57-3) El 0 ✓❑ Mass
PCB-1242 Concentration
5.18 (53469-21-9) 0 ❑ ✓❑ Mass
PCB-1254 Concentration
5.19 (11097-69-1) 0 El ✓❑
Mass
PCB-1221 Concentration
5.20 (11104-28-2) ❑ ❑ 0 Mass
PCB-1232 Concentration
5.21 (11141-16-5) 0 ❑ 0
Mass
PCB-1248 Concentration
5.22 (12672-29-6) El ❑ 0 Mass
PCB-1260 Concentration
5.23 (11096-82-5) ❑ 0 ❑ Mass
PCB-1016 Concentration
5.24 (12674-11-2) 0 ❑ 0 Mass
EPA Form 3510-2C(Revised 3-19) Page 20

EPA Identification Number NPDES Permit Number Facility Name Outfall Number Form Approved 03/05/19
110043162485 NC0088811 Pharmaceutical Product 001 OMB No.2040-0004
TABL - •. u _ _. I •T: P.:1• :. I •► ' .I T•. -• • 1.T CI (')(7)(v))t
Presence or Absence
(check one) Effluent Intake
(optional)
Pollutant/Parameter Testing Units Long-Term
(and CAS Number,if available) Required Believed Believed (specify) Maximum Maximum Average Number Long Number
Present Absent Daily Monthly Term
Daily of of
Discharge Discharge Discharge Analyses Average Analyses
(required) (if available) Value
(if available)
Toxaphene Concentration
5.25 (8001-35-2) ❑ ❑ ✓0 Mass
1 Sampling shall be conducted according to sufficiently sensitive test procedures(i.e.,methods)approved under 40 CFR 136 for the analysis of pollutants or pollutant parameters or
required under 40 CFR chapter I,subchapter N or 0. See instructions and 40 CFR 122.21(e)(3).
EPA Form 3510-2C(Revised 3-19) Page 21

Rain Groundwater
Currently permited
Courtyard Catch Basin Garage Floor Drain Garage Sump Pit Flow Meter Sample Port > to discharge into
CFPUA Sewer Sys.

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USGS Quad: K27NW Wilmington, NC
Outfall Facility Facility
Latitude: 34° 14' 35" N 34° 14'45 2" N
Longitude: 77°57'4"W 77° 56' 56.3"W Location
Stream Class: SC, Sw
Subbasin: 03-06-23 Pharmaceutical Product Development, Inc.
Receiving Stream: Northeast Cape Fear River North NCoo8881 I -New Hanover County
L—.

Notice of Intent to Issue a NPDES Wastewater Permit
NCOO88811 Pharmaceutical Product Development, LLC.
Public Notice
North Carolina Environmental Management Commission/NPDES Unit
1617 Mail Service Center
Raleigh,NC 27699-1617
Notice of Intent to Issue a NPDES Wastewater Permit NC0088811 Pharmaceutical Product
Development, LLC.
The North Carolina Environmental Management Commission proposes to issue a NPDES
wastewater discharge permit to the person(s) listed below. Written comments regarding the
proposed permit will be accepted until 30 days after the publish date of this notice. The Director
of the NC Division of Water Resources (DWR)may hold a public hearing should there be a
significant degree of public interest. Please mail comments and/or information requests to DWR
at the above address. Interested persons may visit the DWR at 512 N. Salisbury Street, Raleigh,
NC to review information on file. Additional information on NPDES permits and this notice
may be found on our website: http://deq.nc.gov/about/divisions/water-resources/water-resources-
permits/wastewater-branch/npdes-wastewater/public-notices,or by calling [phone].
"Pharmaceutical Product Development, Inc., 929 North Front Street, Wilmington,New Hanover
County, applied to renew NPDES permit NC0088811 discharging process wastewater to NE
Cape Fear River, Cape Fear River Basin. Parameters of concern that are water-quality limited
include Ammonia Nitrogen [NH3 as N], Total Arsenic, Total Chromium, Total Molybdenum,
and Total Nickel. This discharge may affect future wasteload allocations in this portion of the
receiving stream."
(Ad expected to run in the Wilmington Star News on 6/24/20)
Send Comments To:
NCDEQ/DWR/NPDES
Water Quality Permitting Section
1617 Mail Service Center
Raleigh,NC 27699-1617
Or Email Comments to: [e-mail]
Comment Period Ends: 7/24/20
View draft permit and related document

ATA
NCDENR
North Carolina Department of Environment and Natural Resources
Pat McCrory Donald R. van der Vaart
Governor Secretary
June 12, 2015
Mr. Bob Verdinek,Assoc. Director
Facilities&Engineering Services
Pharmaceutical Product Development Inc.
929 North Front Street
Wilmington, NC 28402
Subject: Issuance of NPDES Permit Renewal
Permit No. NC0088811
Pharmaceutical Product Development, Inc
Groundwater Remediation Plant
New Hanover County
Facility Class I
Dear Mr.Verdinek:
Division personnel have reviewed and approved your application for renewal of the subject permit. Accordingly,we
are forwarding the attached NPDES discharge permit. This permit is issued pursuant to the requirements of North
Carolina General Statute 143-215.1 and the Memorandum of Agreement between North Carolina and the U.S.
Environmental Protection Agency dated October 15, 2007(or as subsequently amended).
As identified previously,the renewal permit contains the following significant changes from your
current permit:
• The requirement to begin reporting discharge monitoring data electronically using the NC DWR's Electronic
Discharge Monitoring Report (eDMR) internet application has been added to your NPDES permit. [See Special
Condition A. (4.)]
For information on eDMR, registering for eDMR and obtaining an eDMR user account, please visit the following web
page: http://portal.ncdenr.org/web/wq/admin/bog/ipu/edmr.
For information on EPA's proposed NPDES Electronic Reporting Rule, please visit the following website:
http://www2.epa.gov/compliance/proposed-npdes-electronic-reporting-rule.
• Discharge data, collected as part of Pharmaceutical Product Development's Industrial User Permit (IUP), was
evaluated for the period of Jan. 2011 through October 2014. A Reasonable potential analysis was performed on
the data to determine what toxic parameters should continue to be limited, removed, or added to the NPDES permit
as follows:
o Effluent monitoring for silver was removed from the permit because all IUP samples were less than the
detection level.
o Bi-annual IUP sampling for cyanide showed one hit at 17 ug/L and six at <5 ug/L during the past four years
(2011-2014). Since this is a limited data set (less than 8 samples) and all samples were non-detect except
one, quarterly monitoring for cyanide was added to the permit with no limitation.
1617 Mail Service Center,Raleigh,North Carolina 27699-1617
Phone:[phone] Internet:www.ncdenr.gov
An Equal Opportunity\Affirmative Action Employer—Made in part by recycled paper

Mr. Bob Verdinek, Assoc. Director
June 12,2015
Page 2 of 2
o Reasonable Potential to violate state Water Quality Standards (WQSs) was shown using IUP discharge data
for arsenic, chromium, molybdenum, and nickel. As a result, arsenic and chromium limitations and monitoring
were maintained in the permit. Limitations and monitoring were added for molybdenum and nickel.
o IUP discharge data for copper showed reasonable potential for the effluent to violate state Water Quality
Standards. IUP discharge data for Zn did not show potential to violate state WQSs; however,the predicted Zn
concentration was greater than 50%of the total allowable concentration. Copper and zinc have action level
standards which apply in conjunction with toxicity test results. Since the facility is not discharging to state
waters at this time, limitations for copper and zinc are not required but quarterly monitoring for both parameters
was maintained in the permit.
• Some of the wording has changed in Special Condition A. (2.),Acute Toxicity Pass/Fail Limit and the testing
organism was changed to Mysid Shrimp. Per EPA guidance,the most sensitive species should be chosen when
testing only one species(USEPA 1991).Although no species is always the most sensitive to all toxicants,
Mysidopsis bahia has been documented to show a greater sensitivity to ion toxicity than other saltwater test species
(Pillard et al. 2000). Language was inserted at the bottom of this condition that describes a permittee's options for
alternative test species selection.
If any parts, measurement frequencies or sampling requirements contained in this permit are unacceptable to you,
you have the right to an adjudicatory hearing upon written request within thirty(30)days following receipt of this
letter. This request must be in the form of a written petition,conforming to Chapter 150B of the North Carolina
General Statutes, and filed with the Office of Administrative Hearings(6714 Mail Service Center, Raleigh, North
Carolina 27699-6714). Unless such demand is made, this decision shall be final and binding.
Please note that this permit is not transferable except after notice to the Division. The Division may require
modification or revocation and reissuance of the permit. This permit does not affect the legal requirements to
obtain other permits which may be required by the Division of Water Resources or any other Federal, State, or
Local governmental permits that may be required.
If you have any questions concerning this permit, please contact Julie Grzyb by email ([e-mail])or
phone at(919)807-6389.
Sincerely,
SIGNED COPY
S. Jay Zimmerman
Director, Division of Water Resources
Enclosure: NPDES Permit NC0088811
cc: NPDES Unit
Central Files
Wilmington Regional Office/Water Quality Program
e-copy:
Susan Meadows,Aquatic Toxicity Branch

Permit NC0088811
STATE OF NORTH CAROLINA
DEPARTMENT OF ENVIRONMENT AND NATURAL RESOURCES
DIVISION OF WATER RESOURCES
PERMIT
TO DISCHARGE WASTEWATER UNDER THE
NATIONAL POLLUTANT DISCHARGE ELIMINATION SYSTEM
(NPDES)
In compliance with the provision of North Carolina General Statute 143-215.1, other lawful standards and
regulations promulgated and adopted by the North Carolina Environmental Management Commission, and
the Federal Water Pollution Control Act, as amended,the
Pharmaceutical Product Development, Inc.
is hereby authorized to discharge wastewater from outfalls located at the
Pharmaceutical Product Development, Inc.
Ground Water Remediation Plant
929 North Front Street
Wilmington, NC 28402
New Hanover County
to receiving waters designated as the Northeast Cape Fear River within the Cape Fear River Basin in
accordance with effluent limitations,monitoring requirements, and other applicable conditions set forth in
Parts I,II and III hereof.
This permit shall become effective August 1,2015.
This permit and authorization to discharge shall expire at midnight on January 31, 2020.
Signed this day June 12,2015.
SIGNED COPY
S.Jay Zimmerman
Director,Division of Water Resources
By Authority of the Environmental Management Commission
Page 1 of 7

Permit NC0088811
SUPPLEMENT TO PERMIT COVER SHEET
All previous NPDES Permits issued to this facility,whether for operation or discharge are hereby revoked. As
of this permit issuance, any previously issued permit bearing this number is no longer effective. Therefore,the
exclusive authority to operate and discharge from this facility arises under the permit conditions,
requirements,terms, and provisions included herein.
Pharmaceutical Product Development, Inc.
is hereby authorized to:
1. After the Division receives written notification that a discharge will commence, at least 30 days
prior to discharge, operate a 0.029 MGD groundwater remediation wastewater treatment plant
that includes the following components:
• Collection wells and transfer station
• Two (2) 20 micron pre-filters
• Six (6) ion exchange tanks
• Two (2) media tanks
• pH adjustment system
• Hoses, piping, controls, and fittings
• Effluent flow meter
This facility is located at Pharmaceutical Products Development, Inc. Ground Water Remediation
Treatment Plant, on 929 North Front Street, Wilmington, NC 28402 in New Hanover County.
2. Discharge from said treatment facility via outfall 001 at a specified location (see attached map)
into Northeast Cape Fear River, a class SC, Sw stream within the Cape Fear River Basin.
Page 2 of 7

Permit NC0088811
PART I
A. (1.) EFFLUENT LIMITATIONS AND MONITORING REQUIREMENTS
[15A NCAC 02B .0400 et seq., 02B .0500 et seq.]
During the period beginning on the effective date of the permit and after the receipt of written notification
that a discharge will commence for a 0.029 MGD remediation treatment facility, and lasting until expiration,
the Permittee is authorized to discharge through outfall 001. Such discharges shall be limited and monitored1
by the Permittee as specified below:
EFFLUENT LIMITS MONITORING REQUIREMENTS
EFFLUENT
Monthly Weekly Daily Measurement Sample Type Sample
CHARACTERISTICS
Average Average Maximum Frequency Location
Flow 0.029 MGD Continuous Recording Effluent
Total Suspended Solids (TSS) 30.0 mg/L 45.0 mg/L 2/Month Grab Effluent
pH Not greater than 8.5 s.u. nor less than 6.8 s.u. 2/Month Grab Effluent
Ammonia as Nitrogen (NH3-N) 2.0 mg/L 10.0 mg/L 2/Month Grab Effluent
(April 1 —October 31)
Ammonia as Nitrogen (NH3-N) 4.0 mg/L 20.0 mg/L 2/Month Grab Effluent
(November 1 — March 31)
Arsenic2 10 pg/L 10 pg/L 2/Month Grab Effluent
Total Chromium 2 20 pg/L 20 pg/L Monthly Grab Effluent
Total Copper 2, pg/L Monitor and Report Quarterly Grab Effluent
Total Cyanide, pg/L Monitor and Report Quarterly Grab Effluent
Total Molybdenum 2 2 pg/L 2 pg/L Monthly Grab Effluent
Total Nickel 2 8.3 pg/L 75 pg/L Monthly Grab Effluent
Total Zinc 2, pg/L Monitor and Report Quarterly Grab Effluent
Acute Toxicity 3 Quarterly Grab Effluent
Footnotes:
1. No later than 270 days from the effective date of this permit, begin submitting discharge monitoring
reports electronically using NC DWR's eDMR application system. See Special Condition A (4).
2. Samples shall be taken in conjunction with Acute Toxicity Tests
3. Acute Toxicity Pass/Fail (Mysid Shrimp) at 90%; quarterly during March, June,
September, and December, See Special Condition A. (2.). The collection of the sample
shall coincide with a common sample taken for all the other permit Effluent
Characteristic parameters.
Effluent shall contain no floating solids or foam visible in other than trace amounts.
There shall be no visible sheen or other surface films on the grab sample, or the receiving stream traceable to the
effluent.
Page 3 of 7

Permit NC0088811
A. (2.) ACUTE TOXICITY PASS/FAIL LIMIT (QUARTERLY)
[15A NCAC 02B .0200 et seq.]
The permittee shall conduct acute toxicity tests on a quarterly basis using protocols defined in the North
Carolina Procedure Document entitled"Pass/Fail Methodology For Determining Acute Toxicity In A Single
Effluent Concentration" (Revised December 2010 or subsequent versions). The monitoring shall be performed
as a Mysid Shrimp (Mysidopsis bahia) 24 hour static test. The effluent concentration at which there may be at no
time significant acute mortality is 90% (defined as treatment two in the procedure document). The tests will be
performed during the months of March,June, September,and December. These months signify the first
month of each three month toxicity testing quarter assigned to the facility. Effluent sampling for this testing
must be obtained during representative effluent discharge and shall be performed at the NPDES permitted
final effluent discharge below all treatment processes.
Should any single quarterly monitoring indicate a failure to meet specified limits,then monthly
monitoring will begin immediately until such time that a single test is passed.Upon passing,this monthly
test requirement will revert to quarterly in the months specified above.
All toxicity testing results required as part of this permit condition will be entered on the Effluent Discharge
Monitoring Form (MR-1) for the month in which it was performed, using the parameter code TGE3E.
Additionally, DWR Form AT-2 (original) is to be sent to the following address:
Attention: North Carolina Division of Water Resources
Water Sciences Section/Aquatic Toxicology Branch
1623 Mail Service Center
Raleigh,North Carolina 27699-1623
Completed Aquatic Toxicity Test Forms shall be filed with the Water Sciences Section no later than 30 days
after the end of the reporting period for which the report is made.
Test data shall be complete and accurate and include all supporting chemical/physical measurements
performed in association with the toxicity tests, as well as all dose/response data. Total residual chlorine of
the effluent toxicity sample must be measured and reported if chlorine is employed for disinfection of the
waste stream.
Should there be no discharge of flow from the facility during a month in which toxicity monitoring is
required,the permittee will complete the information located at the top of the aquatic toxicity (AT) test form
indicating the facility name,permit number,pipe number,county,and the month/year of the report with the
notation of"No Flow" in the comment area of the form. The report shall be submitted to the Water Sciences
Section at the address cited above.
Should the permittee fail to monitor during a month in which toxicity monitoring is required,then monthly
monitoring will begin immediately until such time that a single test is passed. Upon passing,this monthly test
requirement will revert to quarterly in the months specified above. Assessment of toxicity compliance is
based on the toxicity testing quarter,which is the three month time interval that begins on the first day of the
month in which toxicity testing is required by this permit and continues until the final day of the third month
Should any test data from either these monitoring requirements or tests performed by the North Carolina
Division of Water Resources indicate potential impacts to the receiving stream,this permit may be re-opened
and modified to include alternate monitoring requirements or limits.
NOTE: Failure to achieve test conditions as specified in the cited document, such as minimum control
organism survival and appropriate environmental controls, shall constitute an invalid test and will require
immediate follow-up testing to be completed no later than the last day of the month following the month of
the initial monitoring.
Page 4 of 7

Permit NC0088811
USE OF A DIFFERENT TEST ORGANISM
The permittee may request the use of a different test organism upon documentation that the alternate test
organism would provide an equal or greater level of protection and is appropriate based on the characteristics
of the discharge and receiving stream. Such documentation would consist of one of the following:
1. For saltwater classified streams,a fathead minnow may be assigned as the acute testing species if the
salinity of the receiving stream at the point of discharge is <5 ppt throughout the tidally influenced
cycle. This determination may be based on the best professional judgment of DWR staff or data
collection provided by the permittee and approved by DWR staff. This evaluation should include
vertical profiles of salinity/conductivity measurements at both high tide and low tide over several 24
hour cycles.
2. Three consecutive"side-by-side" tests with results indicating that the alternate test organism is as or
more sensitive to the facility's effluent. Each test series would consist of two separate toxicity tests
conducted on the same sample of effluent with the length of exposure specified by the permit,the
only difference between the tests being the organism used.
3. An alternate plan developed by the permittee and approved by the Aquatic Toxicology Unit that
demonstrates an equal level of protection is offered by the test organism.
For items 2 and 3,it must also be demonstrated that viable and standardized culture techniques are available
for that organism and standardized testing methodologies have been developed and validated. This
demonstration should meet guidance provided by EPA in Section 6 of EPA-821-R-02-012,Short Term Methods
for Estimating the Acute Toxicity of Effluents and Receiving Waters to Freshwater Organisms. Fifth Edition,
2002. Requests to use a different test organism and supporting documentation should be sent to NC DWR,
WSS at the address listed above.
A. (3.) ADDITIONAL EFFLUENT TESTING AND REOPENER
[G.S. 143-215.1(b)]
The Division of Water Quality may request further effluent characteristic evaluation by means of a written
request stating the type of analysis, a due date, and the reason for the analysis. If the analysis indicates the
applicable Effluent Guidelines or Water Quality Standards were exceeded, then the permit can be reopened
and the appropriate limits added. In the event of a new limit being added, upon request from the permittee a
compliance timetable will be established.
A.(4.) ELECTRONIC REPORTING OF DISCHARGE MONITORING REPORTS
[G.S. 143-215.1(B)]
Proposed federal regulations require electronic submittal of all discharge monitoring reports (DMRs) and
specify that,if a state does not establish a system to receive such submittals, then permittees must submit
DMRs electronically to the Environmental Protection Agency (EPA). The Division anticipates that these
regulations will be adopted and is beginning implementation in late 2013.
NOTE: This special condition supplements or supersedes the following sections within Part II of this permit
(Standard Conditions for NPDES Permits):
• Section B. (11.) Signatory Requirements
• Section D. (2.) Reporting
• Section D. (6.) Records Retention
• Section E. (5.) Monitoring Reports
Page 5 of 7

Permit NC0088811
1. Reporting[Supersedes Section D. (2.) and Section E. (5.) (a)]
Beginning no later than 270 days from the effective date of this permit,the permittee shall begin reporting
discharge monitoring data electronically using the NC DWR's Electronic Discharge Monitoring Report
(eDMR) internet application.
Monitoring results obtained during the previous month(s) shall be summarized for each month and
submitted electronically using eDMR. The eDMR system allows permitted facilities to enter monitoring
data and submit DMRs electronically using the internet. Until such time that the state's eDMR application
is compliant with EPA's Cross-Media Electronic Reporting Regulation(CROMERR),permittees will be
required to submit all discharge monitoring data to the state electronically using eDMR and will be
required to complete the eDMR submission by printing, signing, and submitting one signed original and a
copy of the computer printed eDMR to the following address:
NC DENR/ DWR/ Information Processing Unit
ATTENTION: Central Files/ eDMR
1617 Mail Service Center
Raleigh,North Carolina 27699-1617
If a permittee is unable to use the eDMR system due to a demonstrated hardship or due to the facility
being physically located in an area where less than 10 percent of the households have broadband access,
then a temporary waiver from the NPDES electronic reporting requirements may be granted and
discharge monitoring data may be submitted on paper DMR forms (MR 1, 1.1,2,3) or alternative forms
approved by the Director. Duplicate signed copies shall be submitted to the mailing address above.
Requests for temporary waivers from the NPDES electronic reporting requirements must be submitted in
writing to the Division for written approval at least sixty (60) days prior to the date the facility would be
required under this permit to begin using eDMR. Temporary waivers shall be valid for twelve (12)
months and shall thereupon expire. At such time,DMRs shall be submitted electronically to the Division
unless the permittee re-applies for and is granted a new temporary waiver by the Division.
Information on eDMR and application for a temporary waiver from the NPDES electronic reporting
requirements is found on the following web page:
http://portal.ncdenr.org/web/wq/admin/bog/ipu/edmr
Regardless of the submission method,the first DMR is due on the last day of the month following the
issuance of the permit or in the case of a new facility,on the last day of the month following the
commencement of discharge.
2. Signatory Requirements [Supplements Section B. (11.) (b) and supersedes Section B. (11.) (d)]
All eDMRs submitted to the permit issuing authority shall be signed by a person described in Part II,
Section B. (11.)(a) or by a duly authorized representative of that person as described in Part II,Section B.
(11.)(b). A person, and not a position,must be delegated signatory authority for eDMR reporting
purposes.
For eDMR submissions,the person signing and submitting the DMR must obtain an eDMR user account
and login credentials to access the eDMR system. For more information on North Carolina's eDMR
system,registering for eDMR and obtaining an eDMR user account,please visit the following web page:
http://portal.ncdenr.org/web/wq/admin/bog/ipu/edmr
Page 6 of 7

Permit NC0088811
Certification. Any person submitting an electronic DMR using the state's eDMR system shall make the
following certification [40 CFR 122.22]. NO OTHER STATEMENTS OF CERTIFICATION WILL BE
ACCEPTED:
"I certify, under penalty of law, that this document and all attachments were prepared under my direction or
supervision in accordance with a system designed to assure that qualified personnel properly gather and evaluate the
information submitted. Based on my inquiry of the person or persons who manage the system, or those persons
directly responsible for gathering the information, the information submitted is, to the best of my knowledge and
belief, true, accurate, and complete. I am aware that there are significant penalties for submitting false information,
including the possibility of fines and imprisonment for knowing violations."
3. Records Retention [Supplements Section D. (6.)1
The permittee shall retain records of all Discharge Monitoring Reports,including eDMR submissions.
These records or copies shall be maintained for a period of at least 3 years from the date of the report. This
period may be extended by request of the Director at any time [40 CFR 122.41].
Page 7 of 7

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USGS Quad: K27NW Wilmington, NC
Outfall Facility Facility
Latitude: 34° 14'35" N 34° 14'45.2" N .:
Longitude:77° 57'4"W 77° 56'56.3"W Location
Stream Class: SC, Sw -*-
Subbasin:03-06-23 Pharmaceutical Product Development, Inc.
Receiving Stream: Northeast Cape Fear River North NC0088811 -New Hanover County

A \'•
ROY COOPER '� t�
Governor '1u� Q
MICHAELS.REGAN ��m , ,_
Secretary tea`aw,w°' "
LINDA CULPEPPER NORTH CAROLINA
Director Environmental Quality
August 26,2019
Christopher Gross,Associate Director of Real Estate and Facility
Pharmaceutical Product Development,Inc.
929 North Front Street
Wilmington,NC 28402
Subject: NC0088811
PPD Remediation Site
Investigative Monitoring
Dear Mr. Gross,
Several emerging compounds have been found in North Carolina waters, including the chemical 1,4-
dioxane. Data reviewed as part of the Third Unregulated Contaminant Monitoring Rule(UCMR3)has
indicated elevated concentrations for 1,4-dioxane in the Cape Fear River Basin. In addition, ambient
monitoring performed by DWR's Water Sciences Section have confirmed the presence of the chemical in
the Cape Fear River Basin. See ambient monitoring study reports listed under the following link:
https://deq.nc.gov/about/divisions/water-resources/waterresources-data/water-sciences-home-page/1-4-
dioxane ,
Background
1,4-dioxane is a clear liquid that is highly miscible in water. It has historically been used as a solvent
stabilizer and is currently used for a wide variety of industrial and manufacturing purposes. The
compound can be found in industrial solvents,paint strippers, and varnishes and is often produced as a
by-product of chemical processes to manufacture soaps,plastics, and other consumer products.
The U.S. EPA has not established a maximum contaminant level for 1,4-dioxane in drinking water but
has characterized it as"likely to be carcinogenic to humans"and has established a drinking water health
advisory of 35 µg/L. North Carolina has a calculated human health surface water criterion with an
associated estimated lifetime cancer risk of one in one million at a concentration for 1,4-dioxane of 0.35
µg/L in water supplies and 80 µg/L in all other waterbodies(15A NCAC 02B .0208).
Required Actions
To assess the levels of these compounds throughout the Cape Fear and to assist DWR in developing a
Management Strategy to address and reduce levels of these emerging compounds,Industries permitted
under the National Pollution Discharge Elimination System(NPDES)which employ processes associated
with the discharge of these compounds are hereby required to perform investigative monitoring at the
treatment plant effluent for 1,4-dioxane once per month for three consecutive months starting in October
2019. Such investigative actions can be required under 15A NCAC 02B .0508 (b)(2)and G.S. 143-
215.66.
Samples collected should be representative of the typical wastewater discharged from your facility.
Sufficiently sensitive test methods shall be used.
• To locate a lab certified to perform 1,4-dioxane analysis using EPA Method 624.1,please
visit https://deq.nc.gov/about/divisions/water-resources/water-resources-data/water-
-�,- N512orthNorth Carolina DepartmentSalisburyStreet1 of1617 EnMavironmentalilService Center II I Division
RaleighNorth of WaterCarolina Resou27rces
, 699-1617
NORTH CAROLINA
wVw wwF irm�,wOvafm 919.707.9000

scienceshome-page/laboratory-certification-branch/certified-laboratory-listings.Be sure to
specify 1,4-dioxane by EPA method 624.1 when contacting the labs.The Division
recommends that the lab uses sufficiently sensitive test procedures with a target Practical
Quantification Level(PQL)of approximately 1 pig/L.
• In addition to reporting the monthly results on the facility's eDMR,please send a copy of all
three monthly results to the DWR NPDES Complex Permitting Unit by January 31,2020 at
the following email address(please include the lab sheets with the test results):
[e-mail] include your NPDES permit number in your subject
heading.
If your effluent samples exceed the human health surface water criteria for 1,4-dioxane pertaining to your
receiving stream classification,DWR NPDES Complex Permitting Staff will evaluate the impact on the
receiving stream based on your facility's discharge and receiving stream volume. If necessary,NPDES
staff will contact you to develop a corrective action plan to begin reducing or eliminating 1,4-dioxane
discharges from your facility.
More Information
The Department looks forward to working closely with you on this important public health issue. Data
from the Cape Fear River Basin will be evaluated to determine next steps to reduce the discharge of 1,4-
dioxane throughout the State.
Please contact any of the following DWR NPDES Complex Permitting Unit staff members if you
have any questions or concerns: Julie Grzyb 919-707-3605, Cassidy Kurtz 919-707-3613 or Nick
Coco 919-707-3609 or via email([e-mail]).
Sincerely,
(,_ LE---
Linda ulpepper,Director
Division of Water Resources,NCDEQ
Cc: Dana Satterwhite,WSS
Julie Grzyb,NPDES
Morella S.King,Wilmington Regional Office