20070173 Ver 2_Approval Letter_20160405

WaterResources
ENVIRONMENTAL QUALITY
April 5, 2016
Novo Nordisk Pharmaceutical Industries, Inc.
Attn: Mr. Gary Lohr
3612 Powhatan Road
Clayton, NC 27527
PAT MCCRORY
Governor
DONALD R. VAN DER VAART
Secretary
S. JAY ZIMMERMAN
Director
DWR # 07-0173 v2
Johnston County
Subject: Approval of Individual Isolated and Other Non -404 Jurisdictional Wetlands and Waters
Permit with Additional Conditions
Novo Nordisk — Bright Sky Project Facility Expansion
USACE Action ID. No. SAW -2015-02127
Dear Mr. Lohr:
Attached hereto is a copy of Permit No. IWP000005 issued to Mr. Gary Lohr and Novo Nordisk
Pharmaceutical Industries, Inc., dated April 5, 2016. This permit is required for the project in
addition to Individual Water Quality Certification #4051 and Neuse Buffer Authorization issued for
the project on 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 Permit can be
contested as provided in Articles 3 and 4 of General Statute 150B by filing a written petition for an
administrative hearing to the Office of Administrative Hearings (hereby known as OAH) within
thirty (30) calendar days.
A petition form may be obtained from the OAH at http://www.ncoah.com/ or by calling the OAH
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).
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.
State of North Carolina II Environmental Quality i Water Resources
1617 Mail Service Center I Raleigh, North Carolina 27699-1617
919 807 6300

Mailing address for the OAH:
If sending via US Postal Service:
Office of Administrative Hearings
6714 Mail Service Center
Raleigh, NC 27699-6714
Novo Nordisk Pharmaceutical Industries, Inc.
DWR# 07-0173 v2
Individual Permit #IWP000005
Page 2 of 7
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 Department of Environmental Quality:
Sam M. Hayes, General Counsel
Department of Environmental Quality
1601 Mail Service Center
Raleigh, NC 27699-1601
Unless such a petition is filed, this Permit shall be final and binding.
This Permit completes the review of the Division under section 401 of the Clean Water Act and
15A NCAC 02H .1300. Contact me at 919-807-6360 or [e-mail] or Jennifer
Burdette at 919-807-6364 or [e-mail] if you have any questions or
Sincerely,
{
t,. Karen Higgins, Supervisor
401 & Buffer Permitting Branch
cc: Beth Reed, Kimley-Horn and Associates, Inc., 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: 070173v2Novo Nord iskBrightSkyProject(Johnston)__IWP_IC.docx

Novo Nordisk Pharmaceutical Industries, Inc.
DWR# 07-0173 v2
Individual Permit #IWP000005
Page 3 of 7
NORTH CAROLINA 401 WATER QUALITY PERMIT
PERMIT#IWP000005 is issued in conformity with the requirements of Public Laws 92-500 and 95-
217 of the United States and subject to North Carolina's Regulations in 15A NCAC 02H .1300, to
Mr. Gary Lohr and Novo Nordisk Pharmaceutical Industries, Inc., 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,.March
1, 2016, March 3, 2016 and April 1, 2016, and by Public Notice issued by the Division on March 4,
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.
This approval requires you to follow the conditions listed in the Permit below.
Conditions of Permit:
Impacts Approved
The following impacts are hereby approved provided that all of the conditions of the Permit
are met. No other impacts are approved, including incidental impacts. [15A NCAC 02B
.1300(d)
Type of Impact
Amount Approved (units)
Amount Approved (units)
Permanent
Temporary
Site 1— WG
2.18 (acre)
0 (acre)
Isolated Wetlands
Compensatory Mitigation
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 DMS 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 .1305(4)(6) and S. L. 2015-286, Section 4.18.(d)]

Novo Nordisk Pharmaceutical Industries, Inc.
DWR# 07-0173 v2
Individual Permit #IWP000005
Page 4 of 7
Mitigation requirements for impacts to isolated wetlands only apply to the
amount of impact that exceeds the mitigation threshold of 1 acre of isolated
wetlands in the coastal region.
Stormwater Management Plan
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 02B. .1300(d)(5)]
4. 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 .1301 and .1302]
S. 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 .1305(4)(3)]:
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.
Compensatory
River and Sub -basin
Mitigation Required
Number
Wetlands
1.181 (acres)
Neuse
03020201
Mitigation requirements for impacts to isolated wetlands only apply to the
amount of impact that exceeds the mitigation threshold of 1 acre of isolated
wetlands in the coastal region.
Stormwater Management Plan
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 02B. .1300(d)(5)]
4. 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 .1301 and .1302]
S. 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 .1305(4)(3)]:
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.

Novo Nordisk Pharmaceutical Industries, Inc.
DWR# 07-0173 v2
Individual Permit #IWP000005
Page 5 of 7
b. 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.
6. 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 riot 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 .1301
and .1302]
7. 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:
http://portal.ncdenr.org/web/wq/ws/su/npdessw#tab-w. [15A NCAC 02H .1305(d)(5)]
8. 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,
and other diversion structures shall be used to minimize excavation in flowing water. [15A
NCAC 02H .1305(d)(3)]
9. 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]

Novo Nordisk Pharmaceutical Industries, Inc.
DWR# 07-0173 v2 -
Individual Permit #IWP000005
Page 6 of 7
10. Placement of Culverts and Other Structures in Waters and Wetlands C15A NCAC 02H
.1305(d)(4)]
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.
11. 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 .0200]
12. This Permit does not relieve the applicant of the responsibility to obtain all other required
Federal, State, or Local approvals.
13. Continuing Comr)liance
Mr. Gary Lohr and Novo Nordisk Pharmaceutical Industries, Inc. shall conduct construction
activities in a manner consistent with State water quality standards (including any
requirements resulting from compliance with section 303(4) 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 Permit. Before modifying the Permit, the Division shall notify Mr. Gary Lohr and Novo
Nordisk Pharmaceutical Industries, Inc., provide public notice in accordance with 15A NCAC
02H .1303 and provide opportunity for public hearing in accordance with 15A NCAC 02H .1304.
Any new or revised conditions shall be provided to Mr. Gary Lohr and Novo Nordisk
Pharmaceutical Industries, Inc. in writing. [15A NCAC 02H .1304(c)(2)]

Novo Nordisk Pharmaceutical Industries, Inc.
DWR# 07-0173 v2
Individual Permit #IWP000005
Page 7 of 7
14. 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 Permit. 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 Permit and is
responsible for complying with all conditions. Any new owner must notify the Division and
request the Permit be issued in their name. [15A NCAC 02H .1301 and .1302]
15. 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: htt_p://portal.ncdenr.org/web/wq/swp/ws/401/certsandpermits/apply/forms).
[15A NCAC 02H .1302(f)]
16. This Permit grants permission to the director, an authorized representative of the Director, or
DEQ staff, upon the presentation of proper credentials, to enter the property during normal
business hours. [15A NCAC 02H .1302(e)]
This approval to proceed with your proposed impacts or to conduct impacts to waters as
depicted in your application shall expire 5 years from the date of this 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 Permit. [15A NCAC 02H .1304(c)(2) and 15A NCAC 02H .1305]
Non-compliance with or violation of the conditions herein set forth may result in revocation of
this Permit and may also result in criminal and/or civil penalties.
This the 5th day of April 2016
' r
f Karen Higgins, Supervisor
` 401 & Buffer Permitting Branch
IWP000005