20061376 Ver 1_401 Application_20060908

Office Use Only: Form Version March OS
USAGE Action ID No. DWQ No. ~X.A ~ ~ - ~ 3 7 ~
(If anv 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 3
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 here: ^
II. Applicant Information D ~ ~ ~ ~ `/ ~ U
1. Owner/Applicant Information ~ ~ P $ 2006
Name: Novartis Vaccines and Diagnostics -Jerry Hoekwater, USFCC proiect m~na~er. . .
Mailing Address: 4560 Horton Street M/S Z-100 YyETLANDSANRSTOkMWATcRBRANCH
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 Bradv, nroiect scientist
Company Affiliation: Mulkey Engineers & 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 IO

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 Holly Springs Facility
2. T.I.P. Project Number or State Project Number (NCDOT Only): N/A
3. 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 Holl~prin~s (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 Tributar~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 adjacent to the subject property to the east with a moderate density
industrial park 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 by a spine building.
Standard rg ading 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 USACE 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 USACE 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~gned by the USACE due to
internal issues within the USACE.
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 Holl~prings
program; however, there are two additional phases that could possibly be constructed within the
next ten nears if growth in the industry continues. These additional phases are attached to
demonstrate future potential impacts to jurisdictional 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 alon tg he edge of the proposed fill slope and beneath an access road via a
ape, em~tying into the floodplain of the stream downstream of the impacts. These actions
will permanently impact 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
Perennial or Average Impact Area of
Number Stream Name Type of Impact
Intermittent? Stream Width Length Impact
(indicate on ma) Before Im act (linear feet) (acres)
2 UT to Utley Creek Fill Intermittent
- Isolated 3 feet 226
3 UT to Utley Creek Fill Intermittent 3 feet 181
4 UT to Utley Creek Fill Perennial 4 feet 109

2901inear
feet (non-
Total Stream Impact (by length and acreage) 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)

Type of Impact Type of Waterbody

(lake, pond, estuary, 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 project:
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 CreekZare 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 bYthe 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 entirel} for
construction of parking areas and an access road. Water that would have entered this stream
and wetland will by conveyed through both stormwater pipes to awet-detention pond and
through a drainage ditch located near the foot of the proposed constructed fill slope emp in
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 ftz
VII. Impact Justif cation (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 proposed 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
bridging_and 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 approximately 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
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 SDI
Page 6 of 10

A draft of this proposal has been previouslypresented to the USACE and NCDWQ during
initial nroiect 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 program (NCEEP) has agreed to accept this
project into its in-lieu fee compensatory mitigation 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): 3991inear feet (109 linear ft. cnie, 2:1
ratio and 181 linear ft. (a, 1:1 ratio).
Amount of buffer mitigation requested (square feet):
Amount of Riparian wetland mitigation requested (acres):
Amount ofNon-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 (federaUstate) 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 ware feet) Multiplier Required
Miti ation
1 3 (2 for Catawba)
2 1.5
Total
* Zone 1 extends out 30 feet perpendiculaz from the top of the neaz bank of channel; Zone 2 extends an
additional 20 feet from the edge of Zone I.
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 mans eg ment 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 waterl 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 anafter-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 corulector 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 Springs, and is therefore been considered a separate prolect•
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
subject 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 convened 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.
C
Applicant/Agent's Signature Date
(Agent's signature is valid only if an authorization letter from the applicant is provided.)
Page 10 of 10