WQ0034603_Final Permit_20100415

Ad4
C®ENR
North Carolina Department of Environment and Natural Resources
Division of Water Quality
Beverly Eaves Perdue Coleen H. Sullins
Governor Director
April 15, 2010
Mr. Lee Willmon — HSE Manager
Novartis Vaccines & Diagnostics Inc.
475 Green Oaks Parkway
Holly Springs, North Carolina 27540
Dear Mr. Willmon:
Subject: Permit No. WQ0034603
Novartis Vaccines &
Dee F-reeman
Secretary
Diagnostics Facility
Conjunctive Reclaimed Water
System
Wake County
In accordance with your permit application received March 10, 2010, and subsequent additional
information received April 5, 2010, we are forwarding herewith Permit No. WQ0034603, dated April 15,
2010, to Novartis Vaccines '& Diagnostics Inc. for the construction and operation of the subject
conjunctive reclaimed water utilization facilities.
This permit shall be effective from the date of issuance until December 31, 2015, and shall be
subject to the conditions and limitations as specified therein. Please pay particular attention to the
monitoring requirements listed in Attachment B. Failure to establish an adequate system for collecting
and maintaining the required operational information shall result in future compliance problems.
Please note that the Town of Holly Springs will be required to modify reclaimed water generation
permit WQ0032289 (issued March 20, 2008) to authorize the Novartis facility as an approved user of
reclaimed water, in accordance with Condition I.4. of the aforementioned permit.
Please pay special attention to the following permit conditions:
➢ Condition I.1. requires that a revised Soil Scientist evaluation be submitted to the Division for
all irrigation areas where site work had not been completed or permanent vegetation had not
been established as of the DWQ site visit conducted on March 16, 2010. The evaluation shall
be completed upon completion of construction and prior to operation of the permitted
reclaimed water irrigation system.
➢ Condition I.2. requires that an education program be developed and implemented to inform
employees about the proper use of reclaimed water prior to the operation of any portion of the
permitted reclaimed water utilization system.
AQUIFER PROTECTION SECTION
1636 Mail Service Center, Raleigh, North Carolina 27699-1636
Location: 2728 Capital Boulevard. Raleigh, North Carolina 27604 Olie
Phone: [phone] FAX 1: 919-715.0588: FAX 2: 919-715-60481 Customer Service: 1-877-623-6748 NorthCarolina
intemet: www.ncwaterguality.arg
An Equal Opportunity 1 Affirmative Action Employer Naturally
" /tp�6yr ���✓py�

Mr. Willmon
April 15, 2010
Page 2 of 2
Attachment B states that irrigation with reclaimed water is only allowed during the months of
April through November.
If any parts. requirements or limitations contained in this permit arc unacceptable, the Permittee
has the right to request an adjudicatory hearing upon written request within 30 days following receipt of
this permit. This request shall be in the form of a written petition, conforming to Chapter 150B of the
North Carolina General Statutes, and filed with the Office of Administrative Hearings at 6714 Mail
Service Center, Raleigh, NC 27699-6714. Unless such demands are made, this permit shall be final and
binding.
One set of approved plans and specifications is being forwarded to you. If you need additional
information concerning this matter, please contact Lori Montgomery at [phone] or
[e-mail].
Sincerely,
Zr Col n �HSullins
cc: Wake County Health Department
Raleigh Regional Office, Aquifer Protection Section
Mark P. Ashness, PE — CE Group
Technical Assistance and Certification Unit
Permit File WQ0034603
Notebook File WQ0034603

c
NORTH CAROLINA
ENVIRONMENTAL MANAGEMENT COMMISSION
DEPARTMENT OF ENVIRONMENT AND NATURAL RESOURCES
RALEIGH
CONJUNCTIVE RECLAIMED WATER SYSTEM PERMIT
In accordance with the provisions of Article 21 of Chapter 143, General Statutes of North. Carolina as
amended, and other applicable Laws, Rules and Regulations
PERMISSION IS HEREBY GRANTED TO
Novartis Vaccines & Diagnostics Inc.
Wake County
FOR THE
construction and operation of a 124,500 gallon per day (GPD) conjunctive reclaimed water utilization
facility consisting of
one (1) master reclaimed water flow meter; one (1) irrigation flow meter; approximately 13.75 acres of
reclaimed water irrigation on highly landscaped areas (average 33,400 GPD); a rainfall sensor; utilization
of reclaimed water for cooling tower make up and boiler wash down in the existing facility operations
area (average 91,000 GPD); and all associated valves, piping, and appurtenances;
to serve Novartis Vaccines & Diagnostics Facility, with no discharge of wastes to surface waters,
pursuant to the application received March 10, 2010, and subsequent additional information received by
the Division of Water Quality, and in conformity with the project plans, specifications, and other
supporting data subsequently filed and approved by the Department of Environment and Natural
Resources and considered a part of this permit.
This permit shall be effective from the date of issuance until December 31, 2015, and shall be subject to
the following specified conditions and limitations:
WQ0034603 Version 1.0 Shell Version 100209 Page 1 of 7

1. SCHEDULES -.1.
1. Upon completion of construction and prior to operation of the permitted reclaimed water conjunctive
irrigation system, a soil scientist evaluation shall be completed by a North Carolina licensed soil
scientist for proposed irrigation areas where site work was not completed or where permanent
vegetative cover was not established as of the DWQ site visit conducted on March 16, 2010. The
report shall certify that the completed irrigation area(s) are capable of accepting the permitted loading
rate. This report shall specifically address soil compaction, properties of fill material, and the soil's
ability to accept the irrigation water. The requested information must be received by the Division of
Water Quality, Aquifer Protection Section, 1636 Mail Service Center, Raleigh, NC 27699-1628, prior
to operation of applicable portions of the conjunctive use reclaimed water irrigation system.
2. Prior to operation of any portion of the permitted reclaimed water conjunctive use system (irrigation
and/or cooling water), an education program shall be developed and implemented to inform
employees about the proper use of reclaimed water in accordance with Condition H1.8. All
educational materials shall be made available to the Division upon request.
3. In accordance with 15A NCAC 02T .0116, upon completion of construction and prior to operation of
this permitted facility, a certification (attached) shall be submitted from a licensed North Carolina
Professional Engineer certifying that the permitted facility has been installed in accordance with this
permit, Division approved plans and specifications, and other supporting documentation, including
the location of all monitoring wells as applicable. If this project is to be completed in phases and
partially certified, the Permittee shall retain the responsibility to track further construction approved
under the same permit, and shall provide a final certificate of completion once the entire project has
been completed. Mail the Certification to the Division of Water Quality, Aquifer Protection Section,
1636 Mail Service Center, Raleigh, NC 27699-1636.
4. The Raleigh Regional Office, telephone number [phone], shall be notified at least 48 hours in
advance (excluding weekends and holidays) of operation of the installed facilities such that an in -
place inspection can be made. Notification to the Aquifer Protection Section's regional supervisor
shall be made from 8:00 a.m. until 5:00 p.m. on Monday through Friday, excluding State Holidays.
5. No later than six months prior to the expiration of this permit, the Permittee shall request renewal of
this permit on official Division forms. Upon receipt of the request, the Division will review the
adequacy of the facilities described therein, and if warranted, will renew the permit for such period of
time and under such conditions and limitations as it may deem appropriate. Please note Rule 15A
NCAC 02T .0105(d) requires an updated site map to be submitted with the permit renewal
application.
II. PERFORMANCE STANDARDS
The subject non -discharge facilities shall be effectively maintained and operated at all times so there
is no discharge to surface waters, nor any contravention of groundwater or surface water standards.
In the event the facilities fail to perform satisfactorily, including the creation of nuisance conditions
due to improper operation and maintenance, or failure of the utilization areas to adequately assimilate
the reclaimed water, the Permittee shall take immediate corrective actions including Division required
actions, such as the construction of additional or replacement wastewater treatment or utilization
facilities.
2. This permit shall not relieve the Permittee of their responsibility for damages to groundwater or
surface water resulting from the operation of this facility.
3. Application rates, whether hydraulic, nutrient or other pollutant, shall not exceed those specified in
Attachment B.
WQ0034603 Version 1.0 Shell Version 100209 Page 2 of 7

0
V 4. Tho-irrigation system shall be connected to a rain or moisture sensor, which shall indicate when
reclaimed water application is not appropriate in accordance with Conditions 111.4. and 111.5. of this
permit.
5. The following shall be requirements for the reclaimed water distribution, storage and utilization
facilities:
a. All reclaimed water valves, storage facilities and outlets shall be tagged or labeled to warn the
public or employees that reclaimed water is not intended for drinking. Where appropriate, such
warning shall inform the public or employees to avoid contact with reclaimed water.
b. All reclaimed water piping, valves, outlets and other appurtenances shall be color -coded, taped or
otherwise marked to identify the source of the water as being reclaimed water.
i. All reclaimed water piping and appurtenances shall be either colored purple (i.e., Pantone
522) and embossed or integrally stamped or marked "CAUTION: RECLAIMED WATER —
DO NOT DRINK" or be installed with a purple (i.e., Pantone 522) identification tape or
polyethylene vinyl wrap. The warning shall be stamped on opposite sides of the pipe and
repeated every three feet or less.
I Identification tape shall be at least three inches wide and have white or black lettering on
purple (i.e., Pantone 522) field stating "CAUTION: RECLAIMED WATER — DO NOT
DRINK." Identification tape shall be installed on top of reclaimed water pipelines, fastened
at least every 10 feet to each pipe length and run continuously the entire length of the pipe.
iii. Existing underground distribution systems retrofitted for the purpose of distributing
reclaimed water shall be taped or otherwise identified as noted above. This identification
need not extend the entire length of the distribution system, but shall be incorporated within
10 feet of crossing any potable water supply line or sanitary sewer line.
c. All reclaimed water valves and outlets shall be of a type, or secured in a manner, that permits
operation by authorized personnel only.
d. Above -ground hose bibs (i.e., spigots or other hand -operated connections) shall not be present.
Hose bibs shall be located in locked below -grade vaults that shall be clearly labeled non -potable.
As an alternative to the use of locked below -grade vaults with standard hose bibs services, hose
bibs, which can only be operated by a special tool or connected to a special hose connection, may
be placed in non -lockable underground services boxes clearly labeled non -potable.
6. The Permittee shall maintain an active cross -connection control program that shall have the following
minimum requirements:
a. No direct cross -connections shall be allowed between the reclaimed water and potable water
systems.
b. Where both reclaimed water and potable water are supplied to a reclaimed water utilization site, a
reduced pressure principle backflow preventer, an approved air gap separation or other Division
of Environmental Health approved device shall be installed at the potable water service
connection to the use area. The installation of the reduced pressure principle backflow prevention
device shall allow proper testing.
c. Where potable water is used to supplement a reclaimed water utilization system, the Permittee or
potable water supplier shall approve and regularly inspect the air gap separation.
7. Reclaimed water distribution lines shall be located 10 feet horizontally from and 18 inches below any
water line where practicable. Where these separation distances cannot be met, the piping and integrity
testing procedures shall meet water main standards in accordance with 15A NCAC 18C.
8. Reclaimed water distribution lines shall not be less than 100 feet from a well unless the piping and
integrity testing procedures meet water main standards in accordance with 15A NCAC 18C, but in no
case shall they be less than 25 feet from a private well or 50 feet from a public well.
WQ0034603 Version 1.0 Shell Version 100209 Page 3 of 7

9. Reclaimed water distribution lines shall meet the separation distances to sewer lirk-s in accordance
with Rule .0305 of Subchapter 02T.
10. The compliance and review boundaries are established at the reclaimed water utilization area
boundaries. Any exceedance of standards at the compliance or review boundary shall require action
in accordance with 15A NCAC 02L .0106.
11. The Permittee shall apply for a permit modification to establish a new compliance boundary prior to
any sale or transfer of property affecting a compliance boundary.
12. In accordance with 15A NCAC 02L .0107(d), no wells, excluding Division approved monitoring
wells, shall be constructed within the compliance boundary except as provided for in 15A NCAC 02L
.0107(g).
13. The facilities permitted herein shall be constructed according to the following setbacks:
a. The setbacks for reclaimed water utilization sites permitted after September 1, 2006 shall be as
follows (all distances in feet):
i. Surface waters not classified SA:
ii. Surface waters classified SA:
iii. Any well with exception to monitoring wells
25
100
100
b. The setbacks for storage and treatment units permitted after September 1, 2006 shall be as follows
(all distances in feet):
i. Any habitable residence or place of public assembly under separate ownership: 100
ii. Any private or public water supply source: 100
iii. Surface waters: 50
iv. Any well with exception of monitoring wells: 100
v. Any property line: 50
III. OPERATION AND MAINTENANCE REQUIREMENTS
1. The facilities shall be properly maintained and operated at all times. The facilities shall be effectively
maintained and operated as a non -discharge system to prevent the discharge of any wastewater
resulting from the operation of this facility. The Permittee shall maintain an Operation and
Maintenance Plan pursuant to 15A NCAC 02T .0913, which at a minimum shall include operational
functions, maintenance schedules, safety measures and a spill response plan.
2. Upon the Water Pollution Control System Operators Certification Commission's (WPCSOCC)
classification of the subject non -discharge facilities, in accordance with 15A NCAC 08G .0200 the
Permittee shall designate and employ a certified operator in responsible charge (ORC) and one or
more certified operator(s) as back-up ORC(s). The ORC or their back-up shall visit the facilities in
accordance with 15A NCAC 08G .0200, and shall comply with all other conditions specified in the
previously cited rules. At the time of this permit issuance, a certified ORC is not required for non -
conjunctive reclaimed water users.
3. A suitable year round vegetative cover shall be maintained on the irrigation areas at all times, such
that crop health is optimized, allows for even distribution of reclaimed water and allows inspection of
the reclaimed water irrigation system.
4. Adequate measures shall be taken to prevent reclaimed water ponding in or runoff from the reclaimed
water irrigation areas listed in Attachment B.
WQ0034603 Version 1.0 Shell Version 100209 Page 4 of 7

10
5. Irrigation shall not be performed during inclement weather or when the ground is in a condition that
will cause ponding or runoff.
6. Only reclaimed water from the Utley Creek WWTP Reclaimed Water System (Town of Holly
Springs), permit WQ0032289. shall be utilized at the sites listed in Attachment B.
7. Public access to the reclaimed water utilization sites shall be controlled during active site use. Such
controls may include the posting of signs showing the activities being conducted at each site.
8. An education program shall be developed and implemented to inform employees about the proper use
of reclaimed water. Educational material shall be provided to all employees in contact with reclaimed
water equipment, and these materials shall be maintained consistent with the reclaimed water uses.
All educational materials shall be made available to the Division upon request.
IV. MONITORING AND REPORTING REQUIREMENTS
1. Any Division required monitoring (including groundwater, plant tissue, soil and surface water
analyses) necessary to ensure groundwater and surface water protection shall be established, and an
acceptable sampling reporting schedule shall be followed.
2. Per 15A NCAC 02H .0800, a Division certified laboratory shall conduct all laboratory analyses for
the required effluent, groundwater or surface water parameters.
3. The Permittee shall maintain adequate records tracking the amount of reclaimed water distributed or
utilized. At a minimum, these records shall include the following information for each utilization site
listed in Attachment B:
a. Date of reclaimed water utilization;
b. Volume of reclaimed water irrigated (monthly total); and
c. Maintenance of cover crops (for irrigation sites);
d. Volume of reclaimed water utilized for cooling tower system (monthly total).
4. Three copies of all operation and utilization records (as specified in Condition IV.3) on Form NDAR-3
for every site in Attachment B shall be submitted on or before the last day of the following month. If
no activities occurred during the monitoring month, monitoring reports are still required documenting
the absence of the activity. All information shall be submitted to the following address:
Division of Water Quality
Information Processing Unit
1617 Mail Service Center
Raleigh, North Carolina 27699-1617
5. A reclaimed water user inspection log shall be maintained at this facility. This log shall be
maintained at the facility for a period of no less than five years, and shall be made available to the
Division upon request. At a minimum, this log shall include:
a. Visual observations of the reclaimed water user facilities; and
b. Record of preventative maintenance (e.g., pump and valve maintenance, cross connection control,
etc.).
WQ0034603 Version 1.0 Shell Version 100209 Page 5 of 7

6. Noncompliance Notification:
The Permittee shall report by telephone to the Raleigh Regional Office, telephone number (919) 791-
4200, as soon as possible, but in no case more than 24 hours, or on the next working day following
the occurrence or first knowledge of the occurrence of any of the following:
a. Any occurrence at the facility resulting in the treatment of significant amounts of wastes that is
abnormal in quantity or characteristic, including the known passage of a hazardous substance.
b. Any process unit failure (e.g., mechanical, electrical, etc.), due to known or unknown reasons,
rendering the facility incapable of adequate wastewater treatment.
c. Any facility failure resulting in a by-pass directly to receiving surface waters.
d. Any time self -monitoring indicates the facility has gone out of compliance with its permit
limitations.
e. Ponding in or runoff from the utilization sites.
Any emergency requiring immediate reporting (e.g., discharges to surface waters, imminent failure of
a storage structure, etc.) outside normal business hours shall be reported to the Division's Emergency
Response personnel at telephone number [phone], [phone], or [phone].
Persons reporting such occurrences by telephone shall also file a written report in letter form within
five days following first knowledge of the occurrence. This report shall outline the actions taken or
proposed to be taken to ensure the problem does not recur.
V. INSPECTIONS
1. The Permittee shall provide adequate inspection and maintenance to ensure proper operation of the
wastewater treatment and utilization facilities.
2. The Permittee or their designee shall inspect the reclaimed water utilization facilities to prevent
malfunctions, facility deterioration and operator errors resulting in discharges, which may cause the
unintended release of reclaimed water, a threat to human health or a public nuisance. The Permittee
shall maintain an inspection log that includes, at a minimum, the date and time of inspection,
observations made, and any maintenance, repairs, or corrective actions taken. The Permittee shall
maintain this inspection log for a period of five years from the date of the inspection, and this log
shall be made available to the Division upon request.
3. Any duly authorized Division representative may, upon presentation of credentials, enter and inspect
any property, premises or place on or related to the wastewater treatment and utilization facilities
permitted herein at any reasonable time for the purpose of determining compliance with this permit;
may inspect or copy any records required to be maintained under the terms and conditions of this
permit, and may collect groundwater, surface water or leachate samples.
VI. GENERAL CONDITIONS
1. Failure to comply with the conditions and limitations contained herein may subject the Permittee to
an enforcement action by the Division in accordance with North Carolina General Statutes 143-
215.6A to 143-215.6C.
2. This permit shall become voidable if the permitted facilities are not constructed in accordance with
the conditions of this permit, the Division approved plans and specifications, and other supporting
documentation.
WQ0034603 Version 1.0 Shell Version 100209 Page 6 of 7

01
3. Thistpermiv*is effective only with respect to the nature and volume of wastes described in the permit
application; Division approved plans and specifications, and other supporting documentation. No
variances to applicable rules governing the construction or operation of the permitted facilities are
granted, unless specifically requested and approved in this permit pursuant to 15A NCAC 02T
.0105(n).
4. The issuance of this permit does not exempt the Permittee from complying with any and all statutes,
rules, regulations, or ordinances, which may be imposed by other jurisdictional government agencies
(e.g., local, state, and federal). Of particular concern to the Division are applicable river buffer rules
in 15A NCAC 02B .0200; erosion and sedimentation control requirements in 15A NCAC Chapter 4
and under the Division's General Permit NCG010000; any requirements pertaining to wetlands under
15A NCAC 02B .0200 and 02H .0500; and documentation of compliance with Article 21 Part 6 of
Chapter 143 of the General Statutes.
5. In the event the permitted facilities change ownership or the Permittee changes their name. a formal
permit modification request shall be submitted to the Division. This request shall be made on official
Division forms, and shall include appropriate property ownership documentation and other supporting
documentation as necessary. The Permittee of record shall remain fully responsible for maintaining
and operating the facilities permitted herein until a permit is issued to the new owner.
The Permittee shall retain a set of Division approved plans and specifications for the life of the
facilities permitted herein.
7. The Permittee shall maintain this permit until all permitted facilities herein are properly closed or
permitted under another permit issued by the appropriate permitting authority pursuant to 15A NCAC
02T .01050).
8. This permit is subject to revocation or unilateral modification upon 60 days notice from the Division.
Director, in whole or part for the requirements listed in 15A NCAC 02T .0110.
9. Unless the Division Director grants a variance, expansion of the permitted facilities contained herein
shall not be granted if the Permittee exemplifies any of the criteria in 15A NCAC 02T .0120(b).
10. The Permittee shall pay the annual fee within 30 days after being billed by the Division. Failure to
pay the annual fee accordingly shall be cause for the Division to revoke this permit pursuant to 15A
NCAC 02T .0105(e)(3).
Permit issued this the 15"' day of April, 2010
NORTH CAROLINA ENVIRONMENTAL MANAGEMENT COMMISSION
.Z A,---
4r Tolegfi H. Sullins, Director
Division of Water Quality
By Authority of the Environmental Management Commission
Permit Number WQ0034603
WQ0034603 Version 1.0 Shell Version 100209 Page 7 of 7

4e
J Permit No. WQ0034603 Conjunctive Reclaimed Water System
Novartis Vaccines & Diagnostics, Inc. April 15, 2010
Novartis Vaccines & Diagmostics Facility Wake County
ENGINEERING CERTIFICATION
❑ Partial ❑ Final
In accordance with 1 5A NCAC 02T .0116, 1, ,
as a duly registered Professional Engineer in the State of North Carolina, having the Permittee's
authorization to ❑ periodically ❑ weekly ❑ fully observe the construction of the permitted facility,
hereby state to the best of my abilities that due care and diligence was used in the observation of the
construction, such that the facility was built within substantial compliance and intent of this permit, the
Division approved plans and specifications, and other supporting documentation.
❑ Any variation to this permit, the Division approved plans and specifications, and other supporting
documentation has been documented in the attached as -built drawings, and shall serve as the
Permittee's minor modification request to amend the permit accordingly.
Provide a brief narrative description of any variations:
Professional Engineer's Name
Engineering Firm
Mailing Address
City
Telephone
State Zip
E-mail NC PE Seal, Signature & Date
THE COMPLETED ENGINEERING CERTIFICATION, INCLUDING ALL SUPPORTING
INFORMATION AND MATERIALS, SHALL BE SENT TO THE FOLLOWING ADDRESS:
NORTH CAROLINA DEPARTMENT OF ENVIRONMENT AND NATURAL RESOURCES
DIVISION OF WATER QUALITY
AQUIFER PROTECTION SECTION
LAND APPLICATION UNIT
By U.S. Postal Service:
1636 MAIL SERVICE CENTER
By Courier/Special Delivery:
2728 CAPITAL BOULEVARD
RALEIGH, NORTH CAROLINA 27699-1636 RALEIGH, NORTH CAROLINA 27604

Irk
ATTACHMENT B - APPROVED UTILIZATION SITES AND LIMITATIONS
Novartis Vaccines & Diagnostics, Inc. — Novartis Vaccines & Diagnostics Facility
Permit Number: WQ0034603 Version: 1.0
IRRIGATION AREA INFORMATION
APPLICATION LIMITATIONS
Zone
Owner
County
Latitude
Longitude
g
Net
Acreage
Dominant
Soil Series
Parameter
Permitted hourly
Precipitation Rate'
Seasonal
Restrictions
Units
1
Novartis Vaccines & Diagnostics. Inc.
Wake
35'39'10'
78'52'01"
13.75
Mayodan sandy
loam
01284 - Application Surface Irrigation
0.20
April - Nov
in/fir
Total
13.75
I . Irrigation shall be limited to the needs of the cover crops.
2. Irrigation with reclaimed water shall be conducted only during the montlis of April — November.
COOLING TONER UTILIZATION
Zone
Owner
County
Latitude
Longitude
2
Novartis Vaccines & Diagnostics. Inc.
Wake
35'39'10"
78'52'01"
Totals
WQ0034603 Version 1.0 Attachment B Page I of I