20061376 Ver 1_401 Application_20060912

~~ MULKEY
,t~
PD Box 331 27
RALEIGH, NC 27636
PHONE: 9 1 9-B S 1- 1 9 1 2
FAx: [phone]
LETTER OF TRANSMITTAL
To: Lia Myott Date:
NC DENR/Division of Water Quality,
Wetlands Unit
1650 Mail Service Center,
Raleigh, NC 27699-1650
From: Harold Brady
[phone]
Re: Novartis 404/401 application
Job No
I am sending you the following item(s):
~kp ~ to '" ~ 3 ~ to
September 12, 2006
""HAND DELIVERY'""
2006274.00
COPIES DATE NO. DESCRIPTION
1 9/12/2006 Novartis signed PCN application.

These are transmitted as checked below:
® As requested ® For your use
^ For approval ^ For Signatures
^ For review and comment ^
Remarks:
Lia,
Enclosed are seven copies of the signed PCN. Sorry I had over looked that when I was putting them all
together. Hopefully, that's the only silly mistake I made
Thank you for calling and making me aware of it.
Harold Brady
~~~i~~ ~~
S ~ F 1 ~, 2006
UE:I~i' NJi-.I~Ek.OI)ALI1Y
WETiA.MUS RfvD ~T(?f?iNWF;fER BRAI+ECFI

M _LKEY
_~ ~ I -
US Army Coips of Engineers
Raleigh Regulatory Field Office
6508 Falls of the Neuse Road, Suite
Raleigh, North Carolina 27615
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120 p ~ , I r.~ Q \:%
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ATTENTION: Mr. Monty Matthews ~ 1`~ ti ~'r °
USACE Raleigh Regulatory Representative ~./
~EfV WATGsf'~~~lU LITY
fah r-Met d tr.At~,R BRANCH
DATE: August 29, 2006
SUBJECT: Proposed Novartis Vaccines and Diagnostics Facility Holly Springs, D ~ ~ ~ nd~
Wake County, North Carolina u
SEP 1 1 2006
Please find attached the Pre-Construction Notification (PCN) Application Form pENR -WATER QUALITY
for the referenced project. Novartis has proposed to construct a new pharmaceutical wE'TUwps.tivpST~~,,~NA7~eR>!
facility with associated access roads and parking areas. This work will result in 290
linear feet of unavoidable impacts to one jurisdictional stream channel (an unnamed
tributary of Utley Creek) and an area of isolated wetlands. The purpose of the project is
to facilitate industrial development in Holly Springs, North Carolina. The anticipated let
date for this proposed project is September 2006.
Arrangement of the proposed facility with all the buildings and parking areas was
studied and several versions were produced. However, the production line requires a
specific set-up of building locations with parking arranged around the building instead of
all located at one end. After the building arrangement had been decided upon, the
location of Phase 1 needed to be planned such that there was plenty of land on the
property left for Phases 2 and 3 if needed; while keeping in mind the avoidance and
minimization of stream and wetland impacts. In an attempt to avoid wetland and stream
impacts on the southern portion of the subject property the final design of Phase 1 was
located as far north as possible. The limiting element on the north side of the property is
severe slope associated with another perennial stream which had to be avoided for
construction purposes. Though we were not able to completely avoid impacts to
wetlands and streams with the Phase 1 layout, these impacts have been minimized to the
greatest extent practicable and still meet the needs of the project.
Portions of the existing stream depicted in Figures 2, ZA, and C-JSK-6 as Stream
SD and the isolated wetland WD are proposed to be filled. There is no outfall pipe
proposed, instead the waters that would enter the stream will be diverted along the toe of
the proposed fill slope crossing an access road and emptying back into the original stream
downstream of the proposed reinforced earthen retaining wall.
In order to meet the purpose and need of the proposed project it was not feasible
to entirely avoid wetland or stream impacts. Abridging alternative was studied;
however, due to the severe valley slope the bridge would need to be approximately 80
feet long and take up considerable land area needed for the parking and access roads
which would result in increased stream impacts in another location within the subject
property. This would not leave enough land area to build the potential Phase 2 and 3
MULKEY INC. 6750 7RYCN ROAD GARY. NC 2751 1 P^ BOX 3312`/ RALEIGH. NC 27636 PH: 919-851-191 2 FAX: [phone] © WWW. MtJLK EVINC.CCIM

portions. Another alternative suggested was the use of a concrete retaining wall;
however, according to Jacobs Engineering, the wall would have created approximately
the same amount of impacts as the reinforced earthen slope due to the nearly 27 feet of
fill required to bring the site to grade.
The design presented in this permit application was proposed by Jacobs
Engineering and Novartis during meetings attended by agents from the USAGE and the
NCDWQ conducted the week of July 14 at the Town of Holly Springs municipal
building. Stream mitigation will be required by these regulatory agencies for this
proposed project at varying ratios. Impacted perennial streams require compensatory
mitigation at a 2:1 ratio for the USACE, while NCDWQ requires compensatory
mitigation for perennial streams at a 1:1 ratio. Streams determined by the USAGE to be
intermittent-important require a compensatory mitigation ratio of 1: L NCDWQ does not
require compensatory mitigation for intermittent streams. For this project there are 109
linear feet of perennial stream proposed to be impacted and 181 linear feet of
intermittent-important stream proposed to be impacted. These individual regulatory
agencies do not require separate mitigation; therefore, once the compensatory mitigation
is sufficient for the USAGE (which requires higher mitigation costs) then NCDWQ
requirements generally have been met as well. Therefore, the stream compensatory
mitigation will be for 399 linear feet of stream. In addition, 226 linear feet of
internittent-isolated stream channel and 0.39 acres of isolated wetlands will be impacted
by the proposed project. These waters are solely under the jurisdiction of NCDWQ and
are below thresholds requiring compensatory mitigation.
The North Carolina Ecosystem Enhancement Program (EEP) has agreed to
provide Novartis up to 580 linear feet of stream mitigation upon approval of
environmental permits and submittal of fee. In summary, 399 linear feet of stream
channel will be directly mitigated for by EEP. Attached is a copy of the letter from the
North Carolina Ecosystem Enhancement Program (EEP) granting Novartis the
opportunity to pay into their in-lieu fee mitigation program for anticipated stream impacts
as a result of this proposed project.
The project is located within the Cape Fear River subbasin 03-06-07. There are
seven jurisdictional streams within the 167.0 acre subject property; however, there is only
one jurisdictional stream (UT to Utley Creek) within the 51.0 acre Phase 1 area. The UT
to Utley Creek is not depicted on the USGS Apex, NC topographic quadrangle map, but
has been confirmed to be jurisdictional by the USAGE and the NCDWQ because the
stream displays signs of subsurface input and an uninterrupted bed and bank among other
attributes. The concurrence field meetings were conducted on June 16, 2006 with Mr.
Monty Matthews (USACE) and with Mr. Ian McMillan (NCDWQ) on June 9 and 30,
2006. Utley Creek flows into White Oak Creek approximately 3.0 miles southwest of the
project area. NCDWQ has assigned a best usage classification of "C" to Utley Creek and
a stream index number is 18-7-(5.5). The USGS hydrologic unit is 03030004. There are
no high quality waters (HQW), outstanding resource waters (ORW), drinking water
supply waters (WS-I and WS-II), or 303(d) listed streams within aone-mile radius of the
project study area. An area of isolated wetlands is located above the jurisdictional
stream, and is proposed to be impacted by the proposed project.
The United States Fish and Wildlife Service (USFWS) has identified three
Endangered (E) species (red-cockaded woodpecker, Michaux's sumac and dwarf wedge

mussel) and one Threatened (T) species (bald eagle) for which occurrences have been
recorded in Wake County. The land that will be impacted as a result of this project
consists ofpine-hardwood forest, with an existing maintained sewer line easement, and a
significant network of dirt access roads. No suitable habitat is available within the
project area for any of the protected species, except Michaux's sumac.
• Bald eagles are year-round, transient species in North Carolina. Suitable habitat
for the bald eagle consisting of large areas of open water is not present within the
subject property. An area of open water, Thomas Mill Pond, is located several
hundred feet south of the southern property boundary; however, no nests were
observed near the pond. North Carolina Natural Heritage Program (NCNHP)
maps were reviewed on June 14, 2006 to determine if any bald eagle populations
have been identified at or near the project study area. This map review confirmed
that no bald eagle nests or individuals have been reported within aone-mile radius
of the project site. Proposed project construction will not impact this species.
• Suitable habitat for RCW does not exist within the project area since there are no
pine dominated stands of appropriate diameter or age present. The pines that are
present are young (less than 30 years old) and are within thick stands of
hardwoods. NCNHP maps were reviewed on June 14, 2006 to determine if any
RCW populations have been identified at or near the project study area. This map
review confirmed that no known RCWs are located within aone-mile radius of
the project site. Proposed project construction will not impact this species.
• Suitable habitat for Michaux's sumac consisting of sandy or rocky open woods or
open areas of periodic disturbance is present in the project study area. The project
study area is dominated by clayey textured, thickly vegetated areas. However,
there are several locations throughout the subject property that contain more
rocky soils that contain significantly less vegetation. These areas tend to be along
the existing dirt roads, sewer line easements, as well as areas that were formerly
used for logging decks. A plant by plant survey for Michaux's sumac was
conducted by Mr. Tom Barrett and Mr. Scott Hunt, PE within the project study
area on May 2, 2006 for approximately 8man-hours. No Michaux sumac
individuals were observed during this survey. In addition, North Carolina Natural
Heritage Program (NCNHP) maps were reviewed on June 14, 2006 to determine
if any protected species have been identified at or near the project study area.
This map review confirmed that no populations of 1Vlichaux's sumac are known to
occur within aone-mile radius of the project site. Proposed project construction
will not impact this species.
• Suitable habitat for the dwarf wedgemussel consisting of nearly silt-free streams,
with slow to moderate currents within the Neuse or Pamlico river basins is not
present within the project study area. Several freshwater mussels were observed
in the perennial stream in the northern portion of the subject property (Stream
"SA"); however, due to the subject property's location within the Cape Fear River
basin no dwarf wedgemussel are anticipated to be present. NCNHP maps were
reviewed on June 14, 2006 and this map review confirmed that no populations of
dwarf wedgemussel are known to occur within atwo-mile radius of the project
study area. Proposed project construction will not impact this species.

Following your review and concurrence with the proposed action, please issue a
NWP 39 that will authorize construction activities associated with the filling of
jurisdictional stream channel and isolated wetland and stream areas within the proposed
Novartis Vaccines and Diagnostics facility. If you have any questions or comments
concerning the project, please contact me at [phone]. Thank you for your
assistance.
Sincerely,
Harold M. Brady
Staff Scientist
Attachments
PCN
Figure 1 Project Vicinity
Figure 2 Streams and Wetlands (w/ aerial overlay)
Figure 2A Streams and Wetlands (w/o aerial overlay)
Figure 3 Soils Map
Figure 4 Wake County Soil Survey Map
NCDWQ Express Review Acceptance
EEP Acceptance
Permit Drawings (C-JSK-4, C-JSK-6, C-JSK-8)
Alternative Analysis Drawings
Jurisdictional waters plat map
Stream and wetland forms
Protected Species Technical Report
cc: (7 copies w/ application fee and stormwater plan)
Ms. Lia Myott, NCDWQ-Wetlands Unit, Express Review Project Manager
(single copies)
Ms. Heather Keefer, Town of Holly Springs, Environmental Specialist
Mr. Amer Takieddine, Jacobs, Inc., Project Manager
Ms. Deana Dearborn, Novartis, Project Manager

Office Use Only: Dorm Version March OS
USACE Action ID No. DWQ No. ~X ~ ~ ~o ° (~~ ~9
(If any particular item is not applicable to this project, please enter "Not Applicable" or "N/A".)
I. Processing
1. Check all of the approval(s) requested for this project:
® Section 404 Permit ^ Riparian or Watershed Buffer Rules
^ Section 10 Permit ® Isolated Wetland Permit from DWQ
® 401 Water Quality Certification ® Express 401 Water Quality Certification
2. Nationwide, Regional or General Permit Number(s) Requested: NWP 39
3. If this notification is solely a courtesy copy because written approval for the 401 Certification
is not required, check here: ^
4. If payment into the North Carolina Ecosystem Enhancement Program (NCEEP) is proposed
for mitigation of impacts, attach the acceptance letter from NCEEP, complete section VIII,
and check here:
5. If your project is located in any of North Carolina's twenty coastal counties (listed on page
4), and the project is within a North Carolina Division of Coastal Management Area of
Environmental Concern (see the top of page 2 for further details), check h , .~ . ~
~~ ~ r:- ~ 1
~~ ~~i ~-~' ~d
II. Applicant Information ~;
E P 1 ~' 2006
1. Owner/Applicant Information
urw~uP war ~ uuAUrv
Name: Novartis Vaccines and Diagnostics -Jerry Hoekwater, USFCC pr1~~~1~IDb~~w~T~nyR/U1JCF~
Mailing Address: 4560 Horton Street M/S Z-100
Emeryville. CA 94608
Telephone Number: [phone] Fax Number: [phone]
E-mail Address: Deana Dearborn(a~chiron.com
2. Agent/Consultant Information (A signed and dated copy of the Agent Authorization letter
must be attached if the Agent has signatory authority for the owner/applicant.)
Name: Harold Brady. nroiect scientist
Company Affiliation: Mulke~gineers & Consultants, Inc.
Mailing Address: 6750 Tryon Road
Cary, NC, 27511
Telephone Number: [phone] Fax Number: [phone]
E-mail Address: hbrady~a,mulkeyinc.com
Page 1 of 10

III. Project Information
Attach a vicinity map clearly showing the location of the property with respect to local
landmarks such as towns, rivers, and roads. Also provide a detailed site plan showing property
boundaries and development plans in relation to surrounding properties. Both the vicinity map
and site plan must include a scale and north arrow. The specific footprints of all buildings,
impervious surfaces, or other facilities must be included. If possible, the maps and plans should
include the appropriate USGS Topographic Quad Map and NRCS Soil Survey with the property
boundaries outlined. Plan drawings, or other maps may be included at the applicant's discretion,
so long as the property is clearly defined. For administrative and distribution purposes, the
USACE requires information to be submitted on sheets no larger than 11 by 17-inch format;
however, DWQ may accept paperwork of any size. DWQ prefers full-size construction
drawings rather than a sequential sheet version of the full-size plans. If full-size plans are
reduced to a small scale such that the final version is illegible, the applicant will be informed that
the project has been placed on hold until decipherable maps are provided.
1. Name of project: Novartis USFCC Ho1l~prinPs Facility
2. T.I.P. Project Number or State Project Number (NCDOT Only): N/A
Property Identification Number (Tax PIN): Novartis Vaccines & Diagnostics; PIN#
0639928228.
4. Location
County: Wake Nearest Town: Holly Springs
Subdivision name (include phase/lot number):
Directions to site (include road numbers/names, landmarks, etc.):
From US Highway 1 in Raleigh, take NC Highway 55 South toward Holly Springs (take the
bypass for approximately 4.0 miles. Turn right onto New Hill Rd. and take the first left
(approximately 500 ft.) onto Irving Parkway. Take the first right (approximately 700 ft.~
onto Thomas Mill Rd. Continue until road dead ends. This is the edge of the project area.
5. Site coordinates (For linear projects, such as a road or utility line, attach a sheet that
separately lists the coordinates for each crossing of a distinct waterbody.)
Decimal Degrees (6 digits minimum): 35° 39' 03.93" °N 78° 51' 53.91" °W
6. Property size (acres): 167 acres
7. Name of nearest receiving body of water: Unnamed Tributary to Utley Creek
8. River Basin: Cape Fear
(Note -this must be one of North Carolina's seventeen designated major river basins. The
River Basin map is available at http://h2o.enr.state.nc.us/admin/maps/.)
9. Describe the existing conditions on the site and general land use in the vicinity of the project
at the time of this application: The property is currently forested with a sewer line
Page 2 of 10

easement traversing the southern edge of the property. There is a significant network of
maintain dirt access roads with locations of old logging decks throughout. Undeveloped
forest land adjoins the subject property to the north, west, and south. The existing Corr ag ted
Container facility is adiacent to the subject property to the east with a moderate density
industrial nark beyond.
10. Describe the overall project in detail, including the type of equipment to be used:
Approximately 51.0 acres will be graded for six buildings connected bra spine building_
Standard grading and construction equipment including a pan, dump trucks, excavators, and
a crane will be used to grade the land construct the buildings and associated parking, access,
and stormwater control facilities.
11. Explain the purpose of the proposed work: To provide industrial facility to produce
vaccines and other pharmaceuticals.
IV. Prior Project History
If jurisdictional determinations and/or permits have been requested and/or obtained for this
project (including all prior phases of the same subdivision) in the past, please explain. Include
the USAGE Action ID Number, DWQ Project Number, application date, and date permits and
certifications were issued or withdrawn. Provide photocopies of previously issued permits,
certifications or other useful information. Describe previously approved wetland, stream and
buffer impacts, along with associated mitigation (where applicable). If this is a NCDOT project,
list and describe permits issued for prior segments of the same T.I.P. project, along with
construction schedules. There have been no previous environmental permits applied for or
otherwise) associated with the subject property. The USAGE and NCDWQ have conducted a
field verification meeting concerning the streams and wetlands on the subject property and have
seen the mapping; however, these maps have not been formall~si ng ed by the USAGE due to
internal issues within the USAGE.
V. Future Project Plans
Are any future permit requests anticipated for this project? If so, describe the anticipated work,
and provide justification for the exclusion of this work from the current application.
This permit application deals specially with Phase 1 of the Novartis V&D Holly Springs
program; however, there are two additional phases that could possibly be constructed within the
next ten years if growth in the industry continues. These additional phases are attached to
demonstrate future potential impacts to iurisdictional waters; however, the designs for these
other phases will likely change as needed or may never occur.
Page 3 of 10

VI. Proposed Impacts to Waters of the United States/Waters of the State
It is the applicant's (or agent's) responsibility to determine, delineate and map all impacts to
wetlands, open water, and stream channels associated with the project. Each impact must be
listed separately in the tables below (e.g., culvert installation should be listed separately from
riprap dissipater pads). Be sure to indicate if an impact is temporary. All proposed impacts,
permanent and temporary, must be listed, and must be labeled and clearly identifiable on an
accompanying site plan. All wetlands and waters, and all streams (intermittent and perennial)
should be shown on a delineation map, whether or not impacts are proposed to these systems.
Wetland and stream evaluation and delineation forms should be included as appropriate.
Photographs may be included at the applicant's discretion. If this proposed impact is strictly for
wetland or stream mitigation, list and describe the impact in Section VIII below. If additional
space is needed for listing or description, please attach a separate sheet.
1. Provide a written description of the proposed impacts: The existing stream and isolated
stream and wetland will be filled for the access road and parking, facilities. Water within this
drainage area will be redirected to either the stormwater detention pond or through a ditch
which will traverse along the edge of the proposed fill slope and beneath an access road via a
pipe, emptyinP into the flood lain of the stream downstream of the impacts. These actions
will permanentlypact 109 linear feet of jurisdictional perennial stream channel, 181 linear
feet of intermittent-important stream channel, 226 linear feet of intermittent-isolated stream
channel, and 0.38 acres of isolated wetlands.
2. Individually list wetland impacts. Types of impacts include, but are not limited to
mechanized clearing, grading, fill, excavation, flooding, ditching/drainage, etc. For dams,
separately list impacts due to both structure and flooding.
Wetland Impact
Site Number
(indicate on map)
Type of Impact Type of Wetland
(e.g., forested, marsh,
herbaceous, bog, etc.) Located within
100-year
Floodplain
( es/no) Distance to
Nearest
Stream
(linear feet) Area of
Impact
(acres)

1
Fill
Isolated forested headwater
No Adjacent to
isolated
stream
0.38

Total Wetland Impact (acres) 0.38
3. List the total acreage (estimated) of all existing wetlands on the property: 0.96 acre
4. Individually list all intermittent and perennial stream impacts. Be sure to identify temporary
impacts. Stream impacts include, but are not limited to placement of fill or culverts, dam
construction, flooding, relocation, stabilization activities (e.g., cement walls, rip-rap, crib
Page 4 of 10

walls, gabions, etc.), excavation, ditching/straightening, etc. If stream relocation is proposed,
plans and profiles showing the linear footprint for both the original and relocated streams
must be included. To calculate acreage, multiply length X width, then divide by 43,560.
Stream Impact
Number
(indicate on ma)
Stream Name
Type of Impact
Perennial or
Intermittent? Average
Stream Width
Before Im act Impact
Length
(linear feet) Area of
Impact
(acres)
2 UT to Utley Creek Fill Intermittent
- Isolated 3 feet 226
3 UT to Utley Creek Fill Intermittent 3 feet ] 81
4 UT to Utley Creek Fill Perennial 4 feet 109

Total Stream Impact (by length and acreage) 290 linear
feet (non-
isolated
stream)
5. Individually list all open water impacts (including lakes, ponds, estuaries, sounds, Atlantic
Ocean and any other water of the U.S.). Open water impacts include, but are not limited to
fill, excavation, dredging, flooding, drainage, bulkheads, etc.
Open Water Impact
Site Number

(indicate on ma)
Name of Waterbody
(if applicable)
T e of Im act
yp p Type of Waterbody
lake and estua
( ~ P ry, sound, bay,
ocean, etc.) Area of

Impact
(acres)

Total Open Water Impact (acres)
6. List the cumulative impact to all Waters of the U.S. resulting from the proiect:
Stream Impact (acres):
Wetland Impact (acres): Isolated 0.38
Open Water Impact (acres):
Total Impact to Waters of the U.S. (acres): Isolated 0.38
Total Stream Impact (linear feet): 290
7. Isolated Waters
Do any isolated waters exist on the property? ®Yes ^ No
Describe all impacts to isolated waters, and include the type of water (wetland or stream) and
the size of the proposed impact (acres or linear feet). Please note that this section only
applies to waters that have specifically been determined to be isolated by the USACE.
The USACE has determined that the wetlands that are proposed to be impacted (Wetland
WD -located immediately north of the end of the UT to Utley Creek) are isolated due to a
Page 5 of 10

significant break in the intermittent channel in which nearly all characteristics of the stream
channel are lost. Due to the intermittent nature of the isolated stream it is not currently
regulated by the USACE or NCDWQ. However, the isolated wetland immediately above the
nick point of the isolated stream is regulated by NCDWQ. The isolated headwater forested
wetland comprises approximately 0.38 acre and is planned to be filled entirely
construction of parking areas and an access road. Water that would have entered this stream
and wetland will b c~ onveyed through both stormwater pipes to awet-detention pond and
through a drainage ditch located near the foot of the proposed constructed fill slope emptying
into the UT to Utley Creek downstream of the proposed impacts.
8. Pond Creation
If construction of a pond is proposed, associated wetland and stream impacts should be
included above in the wetland and stream impact sections. Also, the proposed pond should
be described here and illustrated on any maps included with this application.
Pond to be created in (check all that apply): ®uplands ^ stream ^ wetlands
Describe the method of construction (e.g., dam embankment, excavation, installation of
draw-down valve or spillway, etc.): The wet-detention pond will be excavated near the
southwestern corner of the proposed facility and will use to collect and treat stormwater
runoff prior to entering any streams or wetland areas.
Proposed use or purpose of pond (e.g., livestock watering, irrigation, aesthetic, trout pond,
local stormwater requirement, etc.): State stormwater requirements
Current land use in the vicinity of the pond: undeveloped forested land
Size of watershed draining to pond: 26.2 acres Expected pond surface area: 15,772 ft2
VII. Impact Justification (Avoidance and Minimization)
Specifically describe measures taken to avoid the proposed impacts. It may be useful to provide
information related to site constraints such as topography, building ordinances, accessibility, and
financial viability of the project. The applicant may attach drawings of alternative, lower-impact
site layouts, and explain why these design options were not feasible. Also discuss how impacts
were minimized once the desired site plan was developed. If applicable, discuss construction
techniques to be followed during construction to reduce impacts.
The stream and isolated wetland~roposed to be impacted can not be completely avoided and
still achieve the goals of the project. Attempts were made to avoid impacts to the stream by
bridgin ag nd by use of a concrete retaining wall. However, due to the the steep nature of the
valley and the proposed thickness or fill (>27 ft.) the bridge would need to be approximate)} 80-
feet long, which would not leave enough space for the all of the proposed buildings. Use of a
concrete retaining wall was considered, but was determined to provide only minimal (10 to 15
ft.) benefit in avoiding stream impacts. It was decided that the best and safest option would be to
construct a reinforced earthen retaining wall.
Impacts to the stream have been minimized by locating the proposed facility as far north on
the property as possible without impacting the perennial stream (Stream SA) or its associated
floodplain located near the northern property boundary. In addition, the reinforced earthen
retaining wall will be constructed using_a 1:1 slope instead of a typical 2:1 or 3:1 slope. This
will require significant reinforcement, but will significantly minimize impacts to the perennial
stream (Stream SDZ
Page 6 of 10

A draft of this proposal has been previously presented to the USACE and NCDWQ during
initial proiect discussions.
VIII. Mitigation
DWQ - In accordance with 15A NCAC 2H .0500, mitigation may be required by the NC
Division of Water Quality for projects involving greater than or equal to one acre of impacts to
freshwater wetlands or greater than or equal to 150 linear feet of total impacts to perennial
streams.
USACE - In accordance with the Final Notice of Issuance and Modification of Nationwide
Permits, published in the Federal Register on January 15, 2002, mitigation will be required when
necessary to ensure that adverse effects to the aquatic environment are minimal. Factors
including size and type of proposed impact and function and relative value of the impacted
aquatic resource will be considered in determining acceptability of appropriate and practicable
mitigation as proposed. Examples of mitigation that may be appropriate and practicable include,
but are not limited to: reducing the size of the project; establishing and maintaining wetland
and/or upland vegetated buffers to protect open waters such as streams; and replacing losses of
aquatic resource functions and values by creating, restoring, enhancing, or preserving similar
functions and values, preferable in the same watershed.
If mitigation is required for this project, a copy of the mitigation plan must be attached in order
for USACE or DWQ to consider the application complete for processing. Any application
lacking a required mitigation plan or NCEEP concurrence shall be placed on hold as incomplete.
An applicant may also choose to review the current guidelines for stream restoration in DWQ's
Draft Technical Guide for Stream Work in North Carolina, available at
http://h2o.enr.state.nc.us/ncwetlands/strmgide.html.
1. Provide a brief description of the proposed mitigation plan. The description should provide
as much information as possible, including, but not limited to: site location (attach directions
and/or map, if offsite), affected stream and river basin, type and amount (acreage/linear feet)
of mitigation proposed (restoration, enhancement, creation, or preservation), a plan view,
preservation mechanism (e.g., deed restrictions, conservation easement, etc.), and a
description of the current site conditions and proposed method of construction. Please attach
a separate sheet if more space is needed.
The North Carolina Ecosystem Enhancement pro rg_am (NCEEP) has agreed to accept this
project into its in-lieu fee compensatory miti ation program. Payment will be made to the
EEP for all of the required compensatory mitigation including 109 linear feet of perennial
stream channel at a 2:1 ratio and 181 linear feet of intermittent stream channel at a 1:1 ratio.
The acceptance letter from NCEEP is attached.
2. Mitigation may also be made by payment into the North Carolina Ecosystem Enhancement
Program (NCEEP). Please note it is the applicant's responsibility to contact the NCEEP at
[phone] to determine availability, and written approval from the NCEEP indicating
that they are will to accept payment for the mitigation must be attached to this form. For
Page 7 of 10

additional information regarding the application process for the NCEEP, check the NCEEP
website at http://h2o.enr.state.nc.us/wrp/index.htm. If use of the NCEEP is proposed, please
check the appropriate box on page five and provide the following information:
Amount of stream mitigation requested (linear feet): 399 linear feet (109 linear ft. n 2:1
ratio and 181 linear ft. (c~ 1:1 ratio).
Amount of buffer mitigation requested (square feet):
Amount of Riparian wetland mitigation requested (acres):
Amount of Non-riparian wetland mitigation requested (acres):
Amount of Coastal wetland mitigation requested (acres):
IX. Environmental Documentation (required by DWQ)
1. Does the project involve an expenditure of public (federal/state/local) funds or the use of
public (federal/state) land? Yes ^ No
2. If yes, does the project require preparation of an environmental document pursuant to the
requirements of the National or North Carolina Environmental Policy Act (NEPA/SEPA)?
Note: If you are not sure whether a NEPA/SEPA document is required, call the SEPA
coordinator at [phone] to review current thresholds for environmental documentation.
Yes ^ No ^
3. If yes, has the document review been finalized by the State Clearinghouse? If so, please
attach a copy of the NEPA or SEPA final approval letter. Yes ^ No ^
X. Proposed Impacts on Riparian and Watershed Buffers (required by DWQ)
It is the applicant's (or agent's) responsibility to determine, delineate and map all impacts to
required state and local buffers associated with the project. The applicant must also provide
justification for these impacts in Section VII above. All proposed impacts must be listed herein,
and must be clearly identifiable on the accompanying site plan. All buffers must be shown on a
map, whether or not impacts are proposed to the buffers. Correspondence from the DWQ
Regional Office may be included as appropriate. Photographs may also be included at the
applicant's discretion.
1. Will the project impact protected riparian buffers identified within 15A NCAC 2B .0233
(Meuse), 15A NCAC 2B .0259 (Tar-Pamlico), 15A NCAC 02B .0243 (Catawba) 15A NCAC
2B .0250 (Randleman Rules and Water Supply Buffer Requirements), or other (please
identify )? Yes ^ No
2. If "yes", identify the square feet and acreage of impact to each zone of the riparian buffers.
If buffer mitigation is required calculate the required amount of mitigation by applying the
buffer multipliers.
Page 8 of 10

Zone* Impact
(s uare feet) Multiplier Required
Miti ation
1 3 (2 for Catawba)
2 1.5
Total
* Zone 1 extends out 30 feet perpendicular from the top of the near bank of channel; Zonc 2 extends an
additional 20 feet from the edge of 7,one 1.
3. If buffer mitigation is required, please discuss what type of mitigation is proposed (i.e.,
Donation of Property, Riparian Buffer Restoration /Enhancement, or Payment into the
Riparian Buffer Restoration Fund). Please attach all appropriate information as identified
within 15A NCAC 2B .0242 or .0244, or .0260. N/A
XI. Stormwater (required by DWQ)
Describe impervious acreage (existing and proposed) versus total acreage on the site. Discuss
stormwater controls proposed in order to protect surface waters and wetlands downstream from
the property. If percent impervious surface exceeds 20%, please provide calculations
demonstrating total proposed impervious level.
There is currently no impervious surface within the proposed roadway corridor. The
estimated impervious surface that will be generated as a result of this project is 14.3 acres of the
51.0 acres that will be cleared and graded. Stormwater runoff will be collected via curb and
gutter or other Stormwater drain devices and will all be conveyed to a stormwater retention pond
approximately one acre in size, located near the southwest corner of the proposed facility. The
stormwater management plan follows the NCDWQ guidelines and is attached. No direct
discharges into streams will result from the proposed design.
XII. Sewage Disposal (required by DWQ)
Clearly detail the ultimate treatment methods and disposition (non-discharge or discharge) of
wastewater generated from the proposed project, or available capacity of the subject facility.
Wastewater produced by the proposed facility will all be collected and conveyed off-site via
the Town of Holly Springs managed sanitary sewer system. Any chemical byproducts produced
during the manufacturing_process (including fire water) will be processed and treated prior to
entering the sanitary sewer.
XIII. Violations (required by DWQ)
Is this site in violation of DWQ Wetland Rules (15A NCAC 2H .0500) or any Buffer Rules?
Yes ^ No
Is this an after-the-fact permit application? Yes ^ No
Page 9 of 10

XIV. Cumulative Impacts (required by DWQ)
Will this project (based on past and reasonably anticipated future impacts) result in additional
development, which could impact nearby downstream water quality? Yes ^ No
If yes, please submit a qualitative or quantitative cumulative impact analysis in accordance with
the most recent North Carolina Division of Water Quality policy posted on our website at
http://h2o.enr.state.nc.us/ncwetlands. If no, please provide a short narrative description:
This project will currently involve the construction of six buildings with a seventh building
acting as a connector to the other six. Access to the facility will be from Thomas Mill Road. For
this project Thomas Mill Road will require up rg ading which will involve paving and widening to
a two-lane facility, and will end at the front entrance of the facility. All potential wetland and
stream impacts associated with Thomas Mill Road have been avoided, and is being constructed
by the Town of Holly SprinPs, and is therefore been considered a separate project.
Future development of the Novartis property will be conducted to the west of the proposed
Phase 1 facility This growth will be limited to only two more additional phases, all associated
with Novartis' Vaccines and Diagnostics program. No additional stream channel impacts are
anticipated and the anticipated wetland impacts would be minor (keeping within the thresholds
of a Nationwide Permit). Thomas Mill Road has been proposed to provide access to these
additional facilities; however, this will be the extent of the road. There is no planned road spur,
cul-de-sac, or dead end to provide for potential development to the north, south, or west of the
su~ect property. In addition, there is no anticipated development from any of the adjacent
properties to the north, south or west. if any of the adjacent properties were to be developed
those facilities would be required to generate their own separate access roads. All stormwater for
Phase 1 and the potential future phases of the Novartis campus will be collected and conve ey d to
stormwater retention ponds and treated before being released into jurisdictional Waters of the
U.S.
Given all of this information this proposed project should not cause any reasonably
anticipated future impacts to water quality in North Carolina.
XV. Other Circumstances (Optional):
It is the applicant's responsibility to submit the application sufficiently in advance of desired
construction dates to allow processing time for these permits. However, an applicant may
choose to list constraints associated with construction or sequencing that may impose limits on
work schedules (e.g., draw-down schedules for lakes, dates associated with Endangered and
Threatened Species, accessibility problems, or other issues outside of the applicant's control).
A draft of this proposal was presented at meetin sg during the week of July 14, 2006, with
avoidance and minimization comments attempted and where workable integrated. The requested
NWP 39 deals specifically with the 290 linear feet of stream impacts. The requested isolated
waters permit deals specifically with the 0.38 acre of isolated wetland impacts.
~~i
i
7~
Applicant/Agent's Signature ~ Date
(Agent's signature is valid only if an authorization letter from the applicant is provided.)
Page 10 of 10

PLAN NOTES
1~ 1 H:2V REINFORCED EARTH SLOPE
RETAINING WALL OVER PERENNW.
STREAM
20 EXISTING TOPOGRAPHY IN THIS AREA
IS BEING SURVEYED AND WILL BE
REVISED.

` NOTE:
~~, ~ STREAM & WETLAND DELINEATIONS SHOWN
\ RELIEVED 7-13-06 AND PERPARED 8Y
MULKEY ENGINEERS & CONSULTANTS.
SURVEYED BY RONALD L. NESARY PLS
N0. NC L-4535.
TH

i

RNR
IAIE
,.

N0. RENSN)NS DATE
A ISSUE FOR 401 0174

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PUW NOTES
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RELIEVED 7-13-06 AND PERPARED BY
MULKEY ENGINEERS & CONSULTANTS.
SURVEYED BY RONALD L NESARY PLS
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No. REVISIONS DATE
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M U LK EYFigure No.
Novartis V & D Holly Springs site
[ENGINEERS & CONSULTANTS Wake County, North Carolina
1:15,840
Feet
0 500 1,000 2,000 3,000 4,000
Wake County Soil Survey, 1970

Novartis Vaccines & Diagnostics, Inc.
4560 Horton Street
Emeryville, California 946082916
1
~ N O VA RT I S Tel [phone]
` www.novartis.com
August 11, 2006
Harold Brady
Mulkey Engineers & Consultants
6750 Tryon Road
Cary, NC 27511
Re: Section 401/404 Permit Application Process
Proposed Novartis USFCC Facility, Phase 1, Holly Springs, NC
Dear Mr. Brady,
Please accept this letter as authorization for Mulkey Engineers & Consultants to act on
behalf of Novartis Vaccines and Diagnostics in the Section 401 /404 permit application
process for the above referenced project.
Sincerely,
I
Jerry Hoekwater
Novartis Vaccines and Diagnostics
USFCC Project Manager

~~ ~ .
~(,~:
~~~~*A.
Ttit TOWN Of
_~~~~y
Springs
r.o f~, s
I?B S. Main SIreM
Ilnuy Springs, n.c z~5ao
wuw. hnl n~springsnc.ui
(919)55?-6221
Far~(919) 55?-5569
August 11, 2006
Harold Brady
Mulkey Engineers & Consultants
6750 Tryon Road
Cary, NC 27511
~Re: Section 40l/404 Pe-mit Application Process
Proposed Holly Springs Novartis site, Phase 1
~ Dear Mr. Brady,
Please accept this letter as authorization for Mulkey Engineers &
Consultants to act on behalf of the Town of Holly Springs in the Section
401/404 permit application process for the above referenced project.
~ Sincerely,
,-'~
St~i~r7. Sudano, PE
Director of Engineering
cc: Heather V. Keefer, CFM, Environmental Specialist
Project File
Correspondence # 50283
Alavor's gf6cc far.:
(Y14) 552-0634

AUCa-25-2006 17:28 FROM:DWQ-WETLANDS 9197336893
d~O~ ~Ar~gQG
~ ~
~ ~
August 25, 2006
E7c~'RESS REYIEIIV ACCEPTANCE LETTER
'Z+JQVartis Vaccines and Diagnostics
l~,ttsi<: ).Vl;s. Deanna Dearborn
45U0 Morton Street, M/S Z-100
Btncryvillc, CA 94G08
Dear 1V,(s. Dearborn:
Project lvanne: Novartis V&D Holly Springs, North Calralilaa Site
Alan W. Klimek, p.F.. T.hrc~t°r
Division °C Water Quality
Wake County
Ole. Au,fuet 25, 2006, the 401 Clversight!)rxpress Perrrri.ttiztg Unit of the Division of Water Quality received a
req}>:cst from Mr. Harold Brady of Mulkey Engineers and Consultants, regarding. a p~jeet known as " Novartis
V&cD Holly Springs Site" for acceptance iunto the Express Review Program. This letter advises you that your
project will be accepted into the Express Review Program once the following items are received:
l) The application fee of 53,000.04 [for 401 Watex Quality CertilxcatYOn + Isolated Wetlands Permit], made
payabl.c to the North Carolina Division of Water Quality];
2) Hive {5) complete and collated copies of tkte PCN Application p'orm;
3) Ortc (1) copy of the Addendum to the PCN;
4) 1~zvc (5) copies of al] site plax- information pertaining to this project (please .refer to the Addendum
h ttP://I>!2a.enr,state.aC.us!>nCw etlands/sanadd5.ndfj;
5) I£ your project requires a stormwater managetxtent plan (30% impervious surface azea or above}, you are
required to submit those plans along with the. application package
Thank you for your attention to this matter.
xhe clock i:'or this project will not start until receipt of. fire completed application package and required fee are
rccca,vcd. If the impacts arc greater than indicated ort< the Initial lnte7-est Form andlor the services are different,
you z~~ay be required to rctnit ari additional fee.
x£ you laa~~e any questions or wish to discuss these matters further please dQ not he3itate to pall Ni3.. LlA 141yott at
919-73~-9502 or. Dlr. Cynthia Van Der Wicle at 919-715-3473.
Sincerely,
~.
C.ynd>I Karoly, NJanager
401/Express R,evicw Oversite Unit
Cl3TC/cudw
CC: 1~1.1C Copy
4010verslghl !Express Review Permhting Unit
1650 Mail Service Gunter, Raleigh, North Carolina 27699-1650
2321 Crabtree Boulevard, Sulk! 250, Raleigh, North Carolina 276Qt1
Phon®: 919.733.1766 f FAX 919-733$893 J Internet ht :~Yh2~i.cnr.R ¢L [6.tic,u~,~acwed~nds
Michael N. Fa¢lcy, C;nvcrn~r
William (i. )Loss Jr., 5ccrctary
Nurlh Carolina Department n£ k;nvimnmeni and Natural liesources
T0: 98511918 P:2~2
N °YhC.~uol na
J~aCurally
An Equal 4pportunNylAtflrrnative Action Employer- 509'o Reaydedf1t~9'a Post Consumer Paper

D8-21-'D6 13, D9 FROM-UENR EEP 91'~715iDD1 T-143 PD2 U-6531
4~/111
~ a eme~.t
PRQS3tiAM
August 21, 2006
FTarold Brady
Mulkey Engineers
6750 Tryon Road
Cary, NC 27511
Project: Novartis Holly Springs Slte County: 'PVake
The purpose of this letter is to notify you that the North Carolina Ecosystem Enhancement Program (NC EEP) is willing to
accept payment for impacts associated with the above referenced project. Please note that this decision does not assure that
the paymer-t will be approved by the permit issuing agencies as mitigation for project impacts, It is rho responsibility of the
applicant to contact these agencies to determine if payment to the NC EEF will be approved.
This acceptance is valid for six months from the date of this letter, if we have not received a copy of the issaed 404
1Permit/401 Certification within this time frame, this acceptance will expire. It is the applicant's responsibility to send
copies of the 404/401/LAMA permits to NC EEP. Once NC lr1rP receives a copy of the 404 Fermit and/or the 401
Certification an invoice will be issued and payment must be made.
>3ased on the information supplied by you the impacts that may require compensatory mitigation are summarized in the
following table.
River Basin Wetlands Streatn t3uffer 13uffer
Cataloging (Acres) (Linear Feet) Zone 1 zone Z
Unit (Sq. l+`t.} (Sq. Pt.)
Ri arias Non-Ri arias Coastal Marsh Cold Cool Warm
Cape Fear 0 0.38 0 0 U 290 0 0
03030004
'Upon receipt of payment, EEP will take responsibility for providing the compensatory mitigation for the permitted impacts
up to a 2:1 mitigation-to-impact ratio, (buffers, Zone 1 at a 3:1 ratio and Zone 2 at a 1.5: l ratio). The type and amount of the
compensatory mitigation will be as specified in the Section 404 Permit and/or 401 'Water Quality Certification, and/or
CAMA Permit. The mitigation will be performed in accordance with the Memorandum of Understanding between the N. C,
)department of l;nvironment and Natural Resources and the U. S. Army Corps of Engineers datad November 4, 1998,
if you have any questions or need additional information, please contact David Robinson at [phone].
Sincerely,
~ . ~~
' iam b. Gilmore, PE
Director
cc: Cyndi Karoly, Wetlands/441 Unit
Monte Matthews, USACE-Raleigh
Eric Kulz, DWQ-Raleigh
File
Reart~ari`c9... ... Prot+~~iC7;~ Oar Stag

North Carolina Ecosystem Enhancement Program, 1652 Mail Service Center, Raleigh, NC 27699-1652 / 919-715-0476 / www.nceep.net

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EMERYVILLE, CA 94608-2916 1880 WAYCROSS RD.
CINCINNATI, OH 45240
CONTACT: DEANA DEARBORN
(TEL) 510.923-3569 CONTACT: AMER TAKIEDDINE

(FAX) 510-652-6059 (TEL) 513-595.7402
(FAX) 51395-7909

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THE TO" OF Project Aardvark 0 1,000 2,000 3,000 4,000 5,000 6,00oet Figure
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~TOtN"0F Project Aardvark o aoo aoo ,,moo Figure
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~' M U LK EY Holly Town of Holly Springs
- „ ~ , .; ~ ~ a ;, ~ o ., 5 ~,, ~T,,., T 5 Springs Wake County, North Carolina Source: Maptech Terrain Navigator Pro Version 7.01 2
n o R r n C A Ft O L l n A Prepared: June 30, 2006 Apex SW - 2002

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~ THE TOWPI OF 0 400 800 1,200 Figure
8 Holly Project Aardvark i Feet
~= M U LK E Y Springs Town of Holly Springs
- - . " ~ ' ` ~"' - `-' `T ` Source: Maptech Terrain Navigator Pro Version 7.01 3
n 0 R T K CAR 0 L t n A Wake County, North Carolina Apex sw- zoo2

pp 9Dx 331 Z7 RAL.EID*4, NC
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