20070173 Ver 2_Approval Letter_20160303

WaterResources
ENVIRONMENTAL. QUALITY
March 3, 2016
Novo Nordisk Pharmaceutical Industries, Inc.
Attn: Mr. Gary Lohr
3612 Powhatan Road
Clayton, NC 27527
NC Department of Transportation (Division 4)
Attn: Mr. Timothy Little
P 0 Box 3165
Wilson, NC 27895
PAT MCCRORY
Governor
DONALD R. VAN DER VAART
Secretal-1,
S. JAY ZIMMEIRMAN
Director
DWR # 07-0173 v2
Johnston County
Subject: Approval of Individual 401 Water Quality Certification and Neuse Riparian Buffer
Impacts with Additional Conditions
Novo Nordisk — Bright Sky Project Facility Expansion & NCDOT
Gordon Road Access
USACE Action ID, No. SAW -2015-02127
Dear Mr. Lohr:
Attached hereto is a copy of Certification No. 4051 issued to Mr. Gary Lohr, Novo Nordisk
Pharmaceutical Industries, Inc. and North Carolina Department of Transportation (NCDOT), dated
March 3, 2016. Please note that you should get any other federal, state or local permits before
proceeding with the subject project, including those required by (but not limited to) Sediment and
Erosion Control, Non -Discharge, and Water Supply Watershed regulations,
This approval and its conditions are final and binding unless contested. This Certification can be
contested as provided in Articles 3 and 4 of General Statute 150E by filing a written petition for an
administrative hearing to the Office of Administrative Hearings (hereby known as OAH) within sixty
(60) calendar days.
A petition form may be obtained from the OAH at tIlpl/wwwj1c 2L� f1.om or by calling the OAH
Z
Clerk's Office at [phone] for information. A petition is considered filed when the original
and one (1) copy along with any applicable OAH filing fee is received in the OAH during normal
office hours (Monday through Friday between 8:00am and 5:00pm, excluding official state
holidays).
Stade of North Carolina � Environmental Quality I Water Resources
1617 Mail Service Center � Raleigh, Norlh Carolina 27699-1617
919 8076300

Novo Nor -disk Pharmaceutical Industries, Inc.
DWR# 07.0173 v2
Individual Certification #4051
Page 2 of 9
The petition may be faxed to the OAH at [phone], provided the original and one copy of
the petition along with any applicable OAH filing fee is received by the OAH within five (5) business
days following the faxed transmission.
Mailing address for the OAH:
If sending via US Postal Service:
Office of Administrative Hearings
6714 Mail Service Center
Raleigh, NC 27699-6714
If sending via delivery service (UPS, FedEx, etc):
Office of Administrative Hearings
1711 New Hope Church Road
Raleigh, NC 27609-6285
One (1) copy of the petition must also be served to DEQ:
Sam M. Hayes, General Counsel
Department of Environmental Quality
1601 Mail Service Center
Raleigh, NC 27699-1601
mimm�=l
This certification completes the review of the Division under section 401 of the Clean Water Act
and 15A NCAC 02H .0500. Contact me at 919-807-6360 or karen higgirr, Pncdenr,gov or Jennifer
Burdette at 919-807-6364 orf,;gv if you have any questions or
1
190111110Y91161M
Sincerely,
Karen Higgins, Supervisor
401 & Buffer Permitting Branch
cc: Beth Reed, Kimley-Horn and Associates, lnc., P 0 Box 33068, Raleigh, NC 27636
USACE Raleigh Regulatory Field Office
Todd Bowers, EPA, Sam Nunn Federal Center, 61 Forsyth Street SW, Atlanta, GA 30303
DWR RRO 401 file
DWR 401 & Buffer Permitting Branch file
Filename: 0701 73v2 Novo Nord is k Brig htS kyP roject(J oh nston)_401—N R B--,IC.docx

Novo Nordisk Pharmaceutical Industries, Inc.
DWR# 07-0173 v2
Individuai Certification #405
Page 3 of 9
CERTIFICATION #4051 is issued in conformity with the requirements of Section 401, Public Laws
92-500 and 95-2:1.7 of the United States and subject to North Carolina's Regulations in 15A NCAC
02H .0500 and 15A NCAC 02B .0200, to Mr. Cary Lohr, Novo Nordisk Pharmaceutical Industries,
Inc., and NCDCIT who have authorization for the impacts listed below, as described within your
application received by the N.C. Division of Water Resources (Division) on December 22, 2015;
subsequent information on February 4, 2016, Larch 1, 2016 and March 3, 2016; and by Public
Notice issued by the U. S. Army Corps of Engineers and received by the Division on January 6,
2016.
The State of North Carolina certifies that this activity will not violate the applicable portions of
Sections 301, 302, 303, 306, .307 of the Public Laws 92-500 and PL 95-217 if conducted in
accordance with the application, the supporting documentation, and conditions hereinafter set
forth.
.rr r �r r r r• r r • .r r r- •
Conditions of Certification:
1. Impacts Approved
The following impacts are hereby approved provided that all of the conditions of the
Certification and Buffer Rules are met. No other impacts are approved, including incidental
Type of Impact Amount Approved(units _ Amount Approved (units
Permanent Temporary
.._ _......... ......_..........._w_..... _.
404/401 Wetlands �..._._..._.
Site 21 _ WE
1.10 (acres) - _
0 (acres)
Site 31 - WB
1.00 (acres)
0 (acres)
Site 41 - WB
.................... __...... _.
010 (acres)
0 (acres)
Site 5 - WA
0.11 (acres)
0 (acres)
_...._
Site 61 - WA
_.__.............. _
0.50 (acres)
0 (acres)
Site 72 - WA _w
-
0.02 (acres)
0 (acres)
Site 82 - WD
Site 92 -WD
2.41 (acres)
0.012 (acres)
0 (acres)
0 (acres)
Site 10` -. WJ
Novo Nordisk Total
0.09 (acres)
2.31 (acres)
0 (acres)
0 (acres)
r._................
Gordon Road Access Total
3.01 (acres)
0 (acres)

Novo Nordisk Pharmaceutical Industries, Inc,
DWR# 07-01.73 v2
Individual Certification #4051
Page 4 of 9
. . . . ............................... . ........... . . . . . .................... ............. . . . . .....
Type of Impact Amount Approved (units) Amount Approved (units)
Permanent Temporary
Stream
Site 8 (linear feet) 0 (linear feet)
. . . .......... . . .. . .... .... .... . ..... . ...... .......
Buffers –Zone I. . . .
Site 9' 11,570 (square feet) 0 (square feet)
. ........................................
Buffers -Zone 2
Site 9'—re feet) 7_0' (square feet)
Novo Nordisk Impacts
Gordon Road Access Impacts
2. Compensatory Mitigation for Novo Nordisk Site
Mitigation must be provided for the proposed impacts as specified in the table below. The
Division has received an acceptance letter from the NC Division of Mitigation Services (DMS)
to meet this mitigation requirement, Until the DIMS receives and clears your payment, and
proof of payment has been provided to this Office, no impacts specified in this Authorization
Certificate shall occur. For accounting purposes, this Authorization Certificate authorizes
payment to the DMS to meet the following compensatory mitigation requirement, [15A NCAC
02B .0506(h)] and 15A NCAC 02B .0233(10)1
3. Stormwater Management Plan for Novo Nordisk Site
You are required to provide one copy of the approved SMP for the Novo Nordisk site, including
plan details on full-sized plan sheets, with proof of Johnston County's approval. The approved
SMP shall be submitted to the DWR 401 & Buffer Permitting Branch (1617 Mail Service Center,
Raleigh, NC 27699-1617) before any impacts authorized in this certification for the Novo
Nordisk site occur. After it is approved and submitted to the Division, the SMP may not be
modified without prior written authorization from Johnston County. if the SMP is modified in
the future, then you shall provide one modified SMP with proof of approval to the DWR 401 &
Buffer Permitting Branch prior to the commencement of the modifications. [15A NCAC 028.
.0506(c)(5)]
4. Final Design for Gordon Road Access
You are required to provide three copies of the final design plans and request a modification
of the 401 Water Quality Certification if impact quantities are revised before any impacts
authorized in this certification for the Gordon Road Access occur.
Compensatory
River and Sub -basin
Mitigation Required_
Number
404/401 Wetlands
2.31 (acres)
Neuse
03020201
3. Stormwater Management Plan for Novo Nordisk Site
You are required to provide one copy of the approved SMP for the Novo Nordisk site, including
plan details on full-sized plan sheets, with proof of Johnston County's approval. The approved
SMP shall be submitted to the DWR 401 & Buffer Permitting Branch (1617 Mail Service Center,
Raleigh, NC 27699-1617) before any impacts authorized in this certification for the Novo
Nordisk site occur. After it is approved and submitted to the Division, the SMP may not be
modified without prior written authorization from Johnston County. if the SMP is modified in
the future, then you shall provide one modified SMP with proof of approval to the DWR 401 &
Buffer Permitting Branch prior to the commencement of the modifications. [15A NCAC 028.
.0506(c)(5)]
4. Final Design for Gordon Road Access
You are required to provide three copies of the final design plans and request a modification
of the 401 Water Quality Certification if impact quantities are revised before any impacts
authorized in this certification for the Gordon Road Access occur.

Novo Nordisk Pharmaceutical Industries, Inc.
DWR# 07-0173 v2
Individual Certification 44051
Page 5 of 9
5. Compensatp_ry Mitigation Plan for Gordon Road Access
Mitigation must be provided for the proposed impacts as specified in the table below. A final
compensatory mitigation plan must be approved in writing by the Division before cony of the
impacts approved herein for the Gordon Road Access are conducted. [15A NCAC 02H .0506
(b)(6)]
Compensatory Credit Mitigation Required
. ....... . .......
Stream 188 (feet)
404/401 3.01 (acres)
Wetlands
Buffers 50,221 (square feet)
.......... . . ............................. .
& Stormwater Management Plan for Gordon Road Access
A final, written stormwater management plan for the Gordon Road Access shall be submitted
to the DWR 401 & Buffer Permitting Branch (1617 Mail Service Center, Raleigh, NC 27699-
1617). The stormwater management plan shall be designed in compliance with NCDOT's
Individual NPDES, permit NCS00250. The stormwater management plan shall be approved by
the Transportation Permitting Branch of the Division before any land disturbance associated
with the Gordon Road Access may occur. [15A NCAC 02H .0506(16)(5)]
No waste, spoil, solids, or fill of any kind shall occur in wetlands, waters, or riparian areas
beyond the footprint of the impacts depicted in the Pre -Construction Notification for this
project, All construction activities, including the design, installation, operation, and
maintenance of sediment and erosion control Best Management Practices shall be
performed so that no violations of state water quality standards, statutes, or rules occur.
Approved plans and specifications for this project are incorporated by reference and are
enforceable parts of this permit, [15A NCAC 02H .0501 and .0502]
8. Sediment and Erosion Control
Erosion and sediment control practices must be in full compliance with all specifications
governing the proper design, installation and operation and maintenance of such Best
Management Practices. If applicable, the project must comply with the specific conditions
and requirements of the NPDES Construction Stormwater Permit issued to the site and the
following requirements [15A NCAC 02H .0506(b)(3) and (c)(3)]:

Novo Nordisk Pharmaceutical Industries, Inc.
DWR# 07-0173 v2
Individual Certification #4051
Page 6 of 9
a. Design, installation, operation, and maintenance of the sediment and erosion control
measures must be such that they equal or exceed the requirements specified in the
most recent version of the North Carolina Sediment and Erosion Control Manual. The
devices shall be maintained on all construction sites, borrow sites, and waste pile
(spoil) projects, including contractor -owned or leased borrow pits associated with the
project.
lb. For borrow pit sites, the erosion and sediment control measures must be designed,
installed, operated, and maintained in accordance with the most recent version of
the North Carolina Surface Mining Manual.
c. Reclamation measures and implementation must comply with the reclamation in
accordance with the requirements of the Sedimentation Pollution Control Act and the
Mining Act of 1971.
d, Sufficient materials required for stabilization and/or repair of erosion control
measures and stormwater routing and treatment shall be on site at all times,
9. Sediment and erosion control measures shall not be placed in wetlands or waters.
Exceptions to this condition require application submittal to and written approval by the
Division. If placement of sediment and erosion control devices in wetlands and waters is
unavoidable, then design and placement of temporary erosion control measures shall not
be conducted in a manner that may result in dis-equilibrium of wetlands, stream beds, or
banks, adjacent to or upstream and downstream of the above structures. All sediment and
erosion control devices shall be removed and the natural grade restored within two (2)
months of the date that the Division of Energy, Mineral and Land Resources (DEMLR) or
locally delegated program has released the specific area within the project. [15A NCAC 02H
.0501 and .0502)
10. Construction Stormwater Permit NCG010000
An NPDES Construction Stormwater Permit is required for construction projects that disturb
one (1 ) or more acres of land. This Permit allows stormwater to be discharged during land
disturbing construction activities as stipulated in the conditions of the permit. If your project
is covered by this permit, full compliance with permit conditions including the erosion &
sedimentation control plan, inspections and maintenance, self-monitoring, record keeping
and reporting requirements is required. A copy of the general permit (NCG010000),
inspection log sheets, and other information may be found at:
bLtp/portaN.ncdenroMWebZvyq/ sysujr)_p.�_e s.wta b -w. 15A NCAC 02H .0506(b)(5) and
(c) (5)]
11. Work in the Dry
All work in or adjacent to stream waters shall be conducted so that the flowing stream does
not come in contact with the disturbed area. Approved best management practices from the
most current version of the NC Sediment and Erosion Control Manual, or the NC DOT
Construction and Maintenance Activities Manual, such as sandbags, rock berms, cofferdams,

Novo Nordisk Pharmaceutical industries, Inc,
DWR# 07-01,73 v2
Individual Certification #4051
Page 7 of 9
and other diversion structures shall be used to minimize excavation in flowing water. [15A
NCAC 02H .0506(b)(3) and (c)(3)1
12. If concrete is used during the construction, then all necessary measures shall be taken to
prevent direct contact between uncured or curing concrete and waters of the state. Water
that inadvertently contacts uncured concrete shall not be discharged to waters of the state
due to the potential for elevated pH and possible aquatic life/fish kills. [15A NCAC 02B .0200]
13, Placement of Culverts and Other Structures in Waters and. Wetlands [15A NCAC 02H
.0506(b)(2) and (c)(2)]
Culverts required for this project shall be installed in such a manner that the original stream
profiles are not altered and to allow for aquatic life movement during low flows. Existing
stream dimensions (including the cross section dimensions, pattern and longitudinal profile)
must be maintained above and below locations of each culvert.
Placement of culverts and other structures in waters, streams must be below the elevation of
the streambed by one (1) foot for all culverts with a diameter greater than 48 inches, and 20
percent of the culvert diameter for culverts having a diameter less than 48 inches, to allow low
flow passage of water and aquatic life.
Installation of culverts in wetlands must ensure continuity of water movement and be designed
to adequately accommodate high water or flood conditions. Additionally, when roadways,
causeways, or other fill projects are constructed across FEMA -designated floodways or
wetlands, openings such as culverts or bridges must be provided to maintain the natural
hydrology of the system as well as prevent constriction of the floodway that may result in
destabilization of streams or wetlands.
The establishment of native, woody vegetation and other soft stream bank stabilization
techniques must be used where practicable instead of rip rap or other bank hardening
methods.
14. Any riprap required for proper culvert placement, stream stabilization, or restoration of
temporarily disturbed areas shall be restricted to the area directly impacted by the approved
construction activity. All riprap shall be buried and/or "keyed in" such that the original stream
elevation and streambank contours are restored and maintained. Placement of riprap or other
approved materials shall not result in de -stabilization of the stream bed or banks upstream or
downstream of the area. [15A NCAC 02H .0506(b)(2)]
15. Any riprap used for stream stabilization shall be of a size and density to prevent movement by
wave action, current action, or stream flows and consist of clean rock or masonry material free
of debris or toxic pollutants. Riprap shall not be installed in the streambed except in specific
areas required for velocity control and to ensure integrity of bank stabilization measures. [15A
NCAC 02H .0506(b)(2)]

Novo Nordisk Pharmaceutical industries, Inc,
DVVR# 07-0173 v2
Individual Certification #4051
Page 8 of 9
16. A one-time application of fertilizer to re-establish vegetation is allowed in disturbed areas
including riparian buffers, but is restricted to no closer than 10 feet from top of bank of
streams. Any fertilizer application must comply with all other Federal, State and Local
regulations. [15A NCAC 02B.0233(6) and 15A NCAC 02B 0231]
17. This Certification does not relieve the applicant of the responsibility to obtain all other
required Federal, State, or Local approvals.
Mr. Gary Lohr, Novo Nordisk Pharmaceutical Industries, Inc, and the NCDOT shall conduct
construction activities in a manner consistent with State water quality standards (including any
requirements resulting from compliance with section 303(d) of the Clean Water Act) and any
other appropriate requirements of State and Federal law. [15A NCAC 02B 0200] If the
Division determines that such standards or laws are not being met (including the failure to
sustain a designated or achieved use) or that State or federal law is being violated, or that
further conditions are necessary to assure compliance, the Division may reevaluate and modify
this Certification. Before modifying the Certification, the Division shall notify Mr. Gary Lohr,
Novo Nordisk Pharmaceutical Industries, Inc., NCDOT and the U.S. Army Corps of Engineers,
provide public notice in accordance with 15A NCAC 02H .0503 and provide opportunity for
public hearing in accordance with 15A NCAC 02H .0504. Any new or revised conditions shall be
provided to Mr. Gary Lohr, Novo Nordisk Pharmaceutical Industries, Inc. and NCDOT in writing,
shall be provided to the U.S. Army Corps of Engineers for reference in any Permit issued
pursuant to Section 404 of the Clean Water Act, and shall also become conditions of the 404
Permit for the project.
19, This approval is for the purpose and design described in your application and as described in
the Public Notice. The plans and specifications for this project are incorporated by reference
and are an enforceable part of the Certification. If you change your project, you must notify
the Division and you may be required to submit a new application package with the
appropriate fee, If the property is sold, the new owner must be given a copy of this
Certification and is responsible for complying with all conditions. Any new owner must notify
the Division and request the Certification be issued in their name, [15A NCAC 02H .0501 and
,0502]
20. The applicant and/or authorized agent shall provide a completed Certificate of Completion
Form to the DWR 401 & Buffer Permitting Branch within ten days of project completion
(available at: tL aDdpeL it� �a f n S),
.................. . . . ......... _pjy/ QjLL
[15A NCAC 02H .0502(f)]
21. This certification grants permission to the director, an authorized representative of the
Director, or DENR staff, upon the presentation of proper credentials, to enter the property
during normal business hours, [15A NCAC 02H .0502(e)]

Novo Nordisk PharmaceUti4 Industries, Inc.
DWR# 07-0173 v2
Individual C'ertification #4051
Page 9 of 9
This approval to proceed with your proposed impacts or to conduct impacts to waters as
depicted in your application shall expire upon expiration of the 404 or LAMA Permit. The
conditions in effect on the date of issuance shall remain in effect for the life of the project,
regardless of the expiration date of this Certification. [15A NCAC 02H .0507(d)(2) and 15A ICAC
02H .05061
Non-compliance with or violation of the conditions herein set forth may result in revocation of
this Certification and may also result in criminal and/or civil penalties.
This the 3rd day of March 2016
a.
Karen Higgins, Supervisor
401 & Buffer Permitting Branch
EM