20070173 Ver 2_Public Notice_20160106

Sullivan, Shelton
From: Harrington, Dorothy SAW <DorothvHaningtonKousace.armymi|>
Sent: Wednesday, January 06, 20I63:15PK4
To: Thomas, John T]RSAW
Cc: Collins, Jocelyn GSAW; Porter, Elizabeth DSAW; Shaeffer, David LSAW
Subject: USArmy Corps ofEngineers Public Notice Novo Nordisk Pharmaceutical Industries,
Inc. 20I5 -02I27
As you requested, you are hereby notified that Wilmington District, United States Army Corps
of Engineers has issued a Public Notice, The text of this document can be found on the
Public Notices portion of the Regulatory Division Home Page. Each Public Notice is available
in ADOBE ACROBAT (.pdf) format for viewing, printing or download at
The current notice involves:
Corps Action ZD#: 20I5-02127
Issue Date: 06 January 2016
Applicants: Novo Nordisk Pharmaceutical Industries, Inc. and N[ Department of Transportation
- Div, 4
Project Name: The Bright Sky Project, Active Pharmaceutical Ingredients (API)
Expiration Date: 08 February 2016
Point of Contact: John Thomas
Project Description:
The Raleigh Regulatory Field Office/ Corps of Engineers (Corps) has received an application
from
Novo Nordisk Pharmaceutical Industries, Inc., and The N[ Department of Transportation - Div.
4/
seeking Department of the Army authorization to discharge dredged or fill material into
waters of the United States, associated with the proposed construction of an Active
Pharmaceutical Ingredients (API) production facility project, The Bright Sky project, in
Johnston County, North Carolina.
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0

1 a
US Army Corps PUBLIC NOTICE
Of Engineers
Wilmington District
Issue Date: January 6, 2016
Comment Deadline: February 8, 2016
Corps Action ID Number: SAW -2015-02127
The Wilmington District, Corps of Engineers (Corps) received an application from Novo
Nordisk Pharmaceutical Industries, Inc. seeking Department of the Army authorization to
discharge dredged or fill material into waters of the United States, associated with The
Bright Sky Project, the proposed construction of an Active Pharmaceutical Ingredients
(API) production facility in Johnston County, North Carolina.
Specific plans and location information are described below and shown on the attached
plans. This Public Notice and all attached plans are also available on the Wilmington
District Web Site at
http://www.saw.usace.army.mil/Missionswww.saw.usace.army.mil/Missions/RegulatoDPermitPro_rg am.aspx
Applicants: Novo Nordisk Pharmaceutical Industries, Inc.
Mr. Gary Lohr
3612 Powhatan Road
Clayton, NC 27527
NC Department of Transportation — Division 4
Mr. Timothy M. Little, P.E., Division Engineer
509 Ward Boulevard
Wilson, NC 27895-1670
Agent: Kimley-Horn and Associates, Inc.
Ms. Beth Reed
3001 Weston Parkway
Cary, NC 27513
Authority
The Corps evaluates this application and decides whether to issue, conditionally issue, or
deny the proposed work pursuant to applicable procedures of the following Statutory
Authorities:
❑ Section 404 of the Clean Water Act (33 U.S.C. 1344)
❑ Section 10 of the Rivers and Harbors Act of 1899 (33 U.S.C. 403)
Version 7.8.2014 Page 1

❑ Section 103 of the Marine Protection, Research and Sanctuaries Act of 1972
(33 U.S.C. 1413)
Location
Directions to Site: From Raleigh, take I-40 East towards US -70 East. Take Exit 309 for
US -70 East. Stay on US -70 for approximately 8.5 miles, and then take Exit 326 for US -
70 Business. Turn left onto US -70 Business West, and continue for on US -70 Business
West for approximately 2 miles. Turn right onto Powhatan Road, and continue for 0.75
miles. The Site will be on the right after crossing over the railroad tracks.
Project Area (acres): 296 Nearest Town: Clayton
Nearest Waterway: Reedy Branch River Basin: Neuse
Latitude and Longitude: 35.616392N, 78.402377W
Existing Site Conditions
The proposed project area consists of approximately 296 -acre and is primarily composed
of agricultural fields (most recently utilized for corn production), fallow fields, and
undeveloped mixed -hardwood forest. The only structure located within the project site is
an abandoned farm house located near Gordon Road in the southernmost portion of the
project site. Land use in the vicinity of the project consists of agricultural development,
low to medium density residential housing, industrial facilities, and undeveloped forested
land. The site is located in the Neuse River Basin (USGS 8 -digit HUC: 03020201). A
single stream, an Unnamed Tributary (UT) to Reedy Branch, was identified south of the
NC/Norfolk Southern railroad. The UT to Reedy Branch flows through the site for 1,224
linear feet before exiting the site via a culvert underneath Gordon Road. There are 79.02
acres of wetlands on-site, of which 2.93 acres are considered isolated wetlands. The
jurisdictional wetlands are dominated by swamp tupelo (Nyssa biflora), tulip -poplar
(Liriodendron tulipifera), loblolly pine (Pinus taeda), red maple (Acer rubrum), sweet bay
(Magnolia virginiana), and sweetgum (Liquidambar styraciflua). Common understory
species observed included ti -ti (Cyrilla racemiflora), sweet pepperbush (Clethra
alnifolia), sweetleaf (Symplocos tinctoria), red chokeberry (Aroma arbutifolia), Chinese
privet (Ligustrum sinense), and black highbush blueberry (Vaccinum fuscatum).
Common species observed in the herbaceous layer typically included slender woodoats
(Chasmanthium laxum), giant cane (Arundinaria gigantea), netted chain fern
(Woodwardia areolata), false -nettle (Boehmeria cylindrica), cinnamon fern
(Osmundastrum cinnamomeum), and Japanese stilt -grass (Microstegium vimineum).
Hydrology within the jurisdictional wetlands is driven by groundwater seepage and
diffuse surface flows.
The proposed site is located in the coastal plain physiographic region of North Carolina.
Topography in the project vicinity is comprised of low rolling hills with gentle slopes
down to wide, level floodplains along streams. Elevations at the project site range from
280 to 310 feet above mean sea level.
Version 7.8.2014 Page 2

Applicant's Stated Purpose
The applicant's stated purpose is to construct an API production facility in North
Carolina. According to the applicant, the project is necessary to expand the company's
ability to produce ingredients for current and future diabetes fighting products.
Expanding API production in the U.S. would supplement Novo Nordisk's current API
footprint in Denmark where production capacity is limited and current supply is unable to
meet the growing global demand.
Project Description
The project would consist of the construction of an approximately 900,000 square foot
API production facility adjacent to the existing Novo Nordisk insulin production facility
on Powhatan Road. The proposed project would include construction of the following:
warehouses for raw material, finished product, and consumable/cold storage;
fermentation buildings for raw product growth; recovery buildings for separation of yeast
and byproducts from API; purification buildings for product refinement; waste water
tank, fire water tank, and cooling towers; office space, gowning, and laboratory building;
central utility building housing boilers for clean steam, processed air and water; electrical
substation; gate houses at facility entrances; waste water pre-treatment facility; parking
facilities; stormwater management basins; and internal roadways. In addition to access
off of Powhatan Road, a southern access is proposed off of Gordon Road which would
include a bridge over the Norfolk Southern railroad.
The cumulative project impacts to waters of the United States for the API production
facility and Gordon Road Access would be 5.32 acres of jurisdictional wetlands and 188
linear feet of jurisdictional stream.
Avoidance and Minimization
The applicant provided the following information in support of efforts to avoid and/or
minimize impacts to the aquatic environment: In order for the manufacturing facility to
be operationally efficient, the structural components need to be in close proximity for
production sequencing as well as truck deliveries and pickup. As a result, the on-site
alternatives must be designed to accommodate the physical layout of the facility in a
manner that would make it operationally efficient and functional. Impacts to waters of the
United States have been avoided and minimized by designing the preferred alternative to
be as far west on the site as feasible. Further, the preferred alternative for the Gordon
Road access would be located in a manner that avoids and minimizes onsite impacts to
jurisdictional streams and wetlands.
Compensatory Mitigation
The applicant offered the following compensatory mitigation plan to offset unavoidable
functional loss to the aquatic environment: The quality and function of the headwater
forest wetlands and the perennial stream system on the Site are high; therefore, a
Version 7.8.2014 Page 3

mitigation ratio of 2:1 is proposed to offset unavoidable impacts to these jurisdictional
feature types. The total mitigation proposed for the project is 376 linear feet of stream
mitigation credits and 10.64 acres of riparian wetland mitigation credits.
Novo Nordisk would be responsible for mitigation associated with impacts resulting from
construction of the Novo Nordisk facility only. The North Carolina Department of
Transportation (NCDOT) would be responsible for the mitigation associated with impacts
to the Gordon Road access only. NCDOT would secure mitigation through active
NCDOT-specific mitigation banks or by payment into the North Carolina Division of
Mitigation Services (NCDMS) In -Lieu Fee (ILF) program, based on available credits at
the time NCDOT initiates construction on the access road. It is anticipated that NCDOT
would secure mitigation for 376 linear feet of stream mitigation credits and 6.07 acres of
riparian wetland mitigation credits.
Novo Nordisk proposes to mitigate for permanent impacts to jurisdictional wetlands
associated with the construction of the Novo Nordisk facility by purchasing 4.57 acres of
riparian wetland mitigation credits from Resource Environmental Solutions, LLC (RES)
banks that are active in the Neuse River Basin (HUC 03020201). Due to the credit need
for this project, and the expected timeline for permit review, RES has provided
documentation that based, on anticipated credit release schedules on the active banks in
the watershed, they expect to be able to provide the required mitigation credits. If the
proposed credit release schedule changes and the required credits are not available at the
time of project construction, Novo Nordisk will secure mitigation for the proposed
impacts by payment into the NCDMS ILF program. NCDMS has accepted Novo
Nordisk's request for in -lieu fee payment for up to 10 acres of riparian wetland mitigation
credits.
Essential Fish Habitat
Pursuant to the Magnuson -Stevens Fishery Conservation and Management Act, this
Public Notice initiates the Essential Fish Habitat (EFH) consultation requirements. The
Corps' initial determination is that the proposed project would not effect EFH or
associated fisheries managed by the South Atlantic or Mid Atlantic Fishery Management
Councils or the National Marine Fisheries Service. The National Oceanic and
Atmospheric Administration (NOAA) EFH Mapper was reviewed on December 15, 2015
and no EFH was located in or within 1.0 -mile of the Site boundary.
Cultural Resources
Pursuant to Section 106 of the National Historic Preservation Act of 1966, Appendix C of
33 CFR Part 325, and the 2005 Revised Interim Guidance for Implementing Appendix C,
the District Engineer consulted district files and records and the latest published version
of the National Register of Historic Places and initially determines that:
❑ Should historic properties, or properties eligible for inclusion in the National
Register, be present within the Corps' permit area; the proposed activity requiring
Version 7.8.2014 Page 4

the DA permit (the undertaking) is a type of activity that will have no potential to
cause an effect to an historic properties.
® No historic properties, nor properties eligible for inclusion in the National
Register, are present within the Corps' permit area; therefore, there will be no
historic properties affected. The Corps subsequently requests concurrence from
the SHPO (or THPO).
❑ Properties ineligible for inclusion in the National Register are present within the
Corps' permit area; there will be no historic properties affected by the proposed
work. The Corps subsequently requests concurrence from the SHPO (or THPO).
❑ Historic properties, or properties eligible for inclusion in the National Register,
are present within the Corps' permit area; however, the undertaking will have no
adverse effect on these historic properties. The Corps subsequently requests
concurrence from the SHPO (or THPO).
❑ Historic properties, or properties eligible for inclusion in the National Register,
are present within the Corps' permit area; moreover, the undertaking may have an
adverse effect on these historic properties. The Corps subsequently initiates
consultation with the SHPO (or THPO).
❑ The proposed work takes place in an area known to have the potential for the
presence of prehistoric and historic cultural resources; however, the area has not
been formally surveyed for the presence of cultural resources. No sites eligible
for inclusion in the National Register of Historic Places are known to be present
in the vicinity of the proposed work. Additional work may be necessary to
identify and assess any historic or prehistoric resources that may be present.
The District Engineer's final eligibility and effect determination will be based upon
coordination with the SHPO and/or THPO, as appropriate and required, and with full
consideration given to the proposed undertaking's potential direct and indirect effects on
historic properties within the Corps -identified permit area.
Endangered Species
Pursuant to the Endangered Species Act of 1973, the Corps reviewed the project area,
examined all information provided by the applicant and consulted the latest North
Carolina Natural Heritage Database. Based on available information:
® The Corps determines that the proposed project would not affect federally listed
endangered or threatened species or their formally designated critical habitat.
❑ The Corps determines that the proposed project may affect federally listed
endangered or threatened species or their formally designated critical habitat.
Version 7.8.2014 Page 5

The Corps initiates consultation under Section 7 of the ESA and will not make a
permit decision until the consultation process is complete.
❑ The Corps is not aware of the presence of species listed as threatened or
endangered or their critical habitat formally designated pursuant to the
Endangered Species Act of 1973 (ESA) within the project area. The Corps will
make a final determination on the effects of the proposed project upon additional
review of the project and completion of any necessary biological assessment
and/or consultation with the U.S. Fish and Wildlife Service and/or National
Marine Fisheries Service.
Other Required Authorizations
The Corps forwards this notice and all applicable application materials to the appropriate
State agencies for review.
North Carolina Division of Water Resources (NCDWR): The Corps will generally not
make a final permit decision until the NCDWR issues, denies, or waives the state
Certification as required by Section 401 of the Clean Water Act (PL 92-500). The receipt
of the application and this public notice, combined with the appropriate application fee, at
the NCDWR Central Office in Raleigh constitutes initial receipt of an application for a
401 Certification. A waiver will be deemed to occur if the NCDWR fails to act on this
request for certification within sixty days of receipt of a complete application. Additional
information regarding the 401 Certification may be reviewed at the NCDWR Central
Office, 401 and Buffer Permitting Unit, 512 North Salisbury Street, Raleigh, North
Carolina 27604-2260. All persons desiring to make comments regarding the application
for a 401 Certification should do so, in writing, by January 26, 2016 to:
NCDWR Central Office
Attention: Ms. Karen Higgins, 401 and Buffer Permitting Unit and Ms. Amy
Chapman, Transportation Permitting Unit
(USPS mailing address): 1617 Mail Service Center, Raleigh, NC 27699-1617
Or,
(physical address): 512 North Salisbury Street, Raleigh, North Carolina 27604
North Carolina Division of Coastal Management (NCDCM):
❑ The application did not include a certification that the proposed work complies
with and would be conducted in a manner that is consistent with the approved
North Carolina Coastal Zone Management Program. Pursuant to 33 CFR 325.2
(b)(2) the Corps cannot issue a Department of Army (DA) permit for the
proposed work until the applicant submits such a certification to the Corps and
the NCDCM, and the NCDCM notifies the Corps that it concurs with the
applicant's consistency certification. As the application did not include the
Version 7.8.2014 Page 6

consistency certification, the Corps will request, upon receipt„ concurrence or
objection from the NCDCM.
® Based upon all available information, the Corps determines that this application
for a Department of Army (DA) permit does not involve an activity which would
affect the coastal zone, which is defined by the Coastal Zone Management (CZM)
Act (16 U.S.C. § 1453).
Evaluation
The decision whether to issue a permit will be based on an evaluation of the probable
impacts including cumulative impacts of the proposed activity on the public interest.
That decision will reflect the national concern for both protection and utilization of
important resources. The benefit which reasonably may be expected to accrue from the
proposal must be balanced against its reasonably foreseeable detriments. All factors
which may be relevant to the proposal will be considered including the cumulative effects
thereof; among those are conservation, economics, aesthetics, general environmental
concerns, wetlands, historic properties, fish and wildlife values, flood hazards, flood plain
values (in accordance with Executive Order 11988), land use, navigation, shoreline
erosion and accretion, recreation, water supply and conservation, water quality, energy
needs, safety, food and fiber production, mineral needs, considerations of property
ownership, and, in general, the needs and welfare of the people. For activities involving
the discharge of dredged or fill materials in waters of the United States, the evaluation of
the impact of the activity on the public interest will include application of the
Environmental Protection Agency's 404(b)(1) guidelines.
Commenting Information
The Corps of Engineers is soliciting comments from the public; Federal, State and local
agencies and officials, including any consolidated State Viewpoint or written position of
the Governor; Indian Tribes and other interested parties in order to consider and evaluate
the impacts of this proposed activity. Any comments received will be considered by the
Corps of Engineers to determine whether to issue, modify, condition or deny a permit for
this proposal. To make this decision, comments are used to assess impacts on endangered
species, historic properties, water quality, general environmental effects and the other
public interest factors listed above. Comments are used in the preparation of an
Environmental Assessment (EA) and/or an Environmental Impact Statement (EIS)
pursuant to the National Environmental Policy Act (NEPA). Comments are also used to
determine the need for a public hearing and to determine the overall public interest of the
proposed activity.
Any person may request, in writing, within the comment period specified in this notice,
that a public hearing be held to consider the application. Requests for public hearings
shall state, with particularity, the reasons for holding a public hearing. Requests for a
Version 7.8.2014 Page 7

public hearing shall be granted, unless the District Engineer determines that the issues
raised are insubstantial or there is otherwise no valid interest to be served by a hearing.
The Corps of Engineers, Wilmington District will receive written comments pertinent to
the proposed work, as outlined above, until 5pm, February 8, 2016. Comments should be
submitted to John Thomas, Raleigh Regulatory Field Office,
3331 Heritage Trade Drive, Suite 105 , Wake Forest, North Carolina 27587, at (907) 554-
4884 ext. 25.
Version 7.8.2014 Page 8

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Applicants: Mr. Gray Lohr-Novo Nordisk Pharmaceutical Industries, Inc.
Mr. Timothy M. Little - North Carolina Department of Transportation
Project Name:The Bright Sky Proejct- Active Pharmeceutical Indgredients (API)
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y m m VOLUME FILL = 807 CU YD
+ y Y d Y a y a
Y y
PHASE 2
Y a
+ + m a y +
y + x
a y Y + a
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p m dy Y Yy Yy d" Y " ya
m
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x xY
EE-
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UTILITY ®IMPACT AREA #5 a d yyx
BUILDING EMP WETLAND FILL = 0.11 AC
EMOP O VOLUME FILL = 887 CU YD
LECTRICAL �GUARD
HOUSE Y "
\ E/T7 I SUBSTATION
O EFDEE Engineering Professional Corporation 100 Fluor Daniel Drive, Greenville, SC 29607 License No. C-0742
Novo Nordisk
%novo nordisli I[DiabetesAPWS
COUNTY: JOHNSTON NovoNord111A/S Revision dale: 17DEC15 CIVIL
Clayt°n, North Carolina WATERWAY: Pov�hatanRoad DrawnDesign B B : CIT IMPACT 3,4 & 5
RIVER BASIN: NEUSE RIVER USA : AFZ DETAIL
DATE OF PUBLIC NOTICE: scale:__ GRAPHIC USACE # SAW -2015-02127
FIGURE 4 of 5

Action Id: 2015-02127
Applicants: Mr. Gray Lohr-Nova Nordisk Pharmaceutical Industries, Inc.
Mr. Timothy M. Little- North Carolina Department of Transportation
Project Name:The Bright Sky Proejct- Active Pharmeceutical Indgredients (API)
Sheet 8 of 10
FIGURE 5
0 50' 100' 200' 300' 400' 500'
C ELECT.
SUBST y a y
a y m
x y
y y x
a y a a
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WETLAND IMPACTS
a'
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ROAD ACCESS x
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WILL BE DESIGNED , xa
CONSTRUCTED, AND IMPACTS Yx
MITIGATED BY NCDOT r
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PROPOSED ACCESS ya as YYyy ayxxyx as as
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y y
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O EFDEE Engineering Professional Corporation 100 Fluor Daniel Drive, Greenville, SC 29607 License No. C-0742
COUNTY: JOHNSTON
WATERWAY:
BASIN: NEUSE RIVER
DATE OF PUBLIC NOTICE:
novo nordisli
Novo Nordisk AIS
PwhatanRoad
USA on,NodhCarolina
laytRIVER
Novo Nordisk
Diabetes API -US
Creation date: 28OCT15
CIVIL
IMPACT 6 & 7
DETAIL
USACE # SAW -2015-02127
Revision date: 17DEC15
DraWn6 : CIT
Design B AFZ
s°ale'-- GRaPHIC
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Action Id: 2015-02127
Applicants: Mr. Gray Lohr-Novo Nordisk Pharmaceutical Industries, Inc.
Mr. Timothy M.Little - North Carolina Department of Transportation
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Project Name:The Bright Sky Proejct- Active Pharmeceutical Indgredients (API)
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Legend development/impacts to this area are
proposed and jurisdictional features r
---Stream associated with this area have not;
USACE Jurisdictional Wetland been delineated.
NCDWR Jurisdictional Isolated Wetland
Unregulated Isolated Wetlands,"'` h
Area Not Delineated{
Feet
Project Study Area 0 350 700 1,050 1,400
Figure 5: Jurisdictional Features Map
Bright Sky Project
1 ����� Clayton, Johnston County
December 2015