WQ0034603_Correction_20120222

NCDENR
North Carolina Department of Environment and Natural Resources
Division of Water Quality
Beverly Eaves Perdue Charles Wakild, P.E. Dee Freeman
Governor Director Secretary
February 22 2012
Mr. Lee Willmon — HSE Manager
Novartis Vaccines & Diagnostics Inc.
475 Green Oaks Parkway
Holly Springs, North Carolina 27540
Subject: Correction WQ0034603
Novartis Vaccines &
Diagnostics Facility
Conjunctive Reclaimed Water
System
Wake County
Dear Mr. Willmon:
In accordance with your letter dated February 9, 2012, we are forwarding herewith a correction to
Permit No., WQ0034603, issued April 15, 2010 to Novartis Vaccines & Diagnostics Inc. The permit
4o., description has been corrected to more accurately reflect the current and future reclaimed water flow
condition at your facility, and clarifies that the flow estimates that are part of the permit description are
not limits and are used for planning and tracking purposes only.
If you need additional information concerning this matter, please contact me at [phone] or
[e-mail].
/onRiEd
Environmental Engineer
cc: Raleigh Regional Office, Aquifer Protection Section
Stephanie Sudano, Holly Springs, P.O. Box 8 Holly Springs, NC 27540
Permit File WQ0034603
Notebook File WQ0034603
AQUIFER PROTECTION SECTION
1636 Mail Service Center, Raleigh, North Carolina 27699-1636
Location: 2728 Capital Boulevard, Raleigh, North Carolina 27604
Phone; 919-733-32211 FAX 1: 919-715-0588; FAX 2: 919-715-60481 Customer Service: i-877-623-6748
Intemet: vvwvv.ncwaterquaIiN.o
An Equal Opportunity 1 Affirmative Action Employer
NorthCarolina
;aturallff

i � V it fft CAROM L -NA
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 conjunctive reclaimed water utilization facility consisting of:
..ma�
one (1) master reclaimed water flow meter; one (1) irrigation flow meter; approximately 13.75 acres of
reclaimed water irrigation on highly landscaped areas (expected use of approximately 33,400 GPD); a
rainfall sensor; utilization of reclaimed water for cooling tower make up and boiler wash down in the 10*A,
existing facility operations area (expected use of approximately 163,000 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
Note that the approximated flow values associated with landscape irrigation and cooling water are for
planning use and are not maximum flow limitations. These flow estimates will be updated in future
permit renewals and modifications to more accurately represent the operating condition at the facility.
Usage limits are included in Attachment B of this permit and additional limits may be established as part
of the user agreement with the reclaimed water provider.
This permit shall be effective from the date of issuance until December 31, 20I5, and shall be subject to
the following specified conditions and limitations:
.:.m
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T. FCTT7T)TTTY5
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 soiI'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.
In accordance with ISA NCAC 02T.01 16, 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 an roved
under the same permit, and shall Qrovide 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 (919) 7914200, shall be notified at least 48 hours in
AMIN 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
. i1.1 ,...1c,i: S tt :r.;.- i' ('.
application.
H. 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.
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4. The irrigation system shall he connected to a rain or moisture sensor, which shall.1ndicafe when
reclaimed water application is not appropriate ui accorciance wita Conditions RiA. and 1ll.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: RECLAMIED 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.
ii. 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. 'oft`
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.
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.
S. 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.
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9. RH*nimc4 w, -.for dis+ri',iainr lineF s},all mcet the senarntinn distar.res to sower lines in nccordnnce
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):
L 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
OPERATION AND MAINTENANCE REQUIREMENTS
TI;: ric i!i:ie.. :hali ;( .' ,1I Lill tirnc>. .l_!x I: cili ies ;h;fll he crret-0-4
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
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.
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5. Irrigation shall not be performed during'inelement..weather or when the ground is in atondition that
wiil cause ponuiug or runoi.
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 IV3) 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 activily. All informAinn shall be submitted to the fnllmrine address:
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.).
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5. Noncor-l;liance Notific:-iior
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
.;i;�,'; {�.' '1'. 'i{ .:x'11{'i{iii' t(' ;1, : �;,:I:.i;" .'•r)!? I -i r�ii.'��,
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
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3. This permit is effective only with respect to -the nature and volume of wastes described in the permit
applicalion; Division approvea plaits and spvciticaiioi►s, and ouier 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" 702T
.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 NCGO 10000; 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.
6. 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. 1411)
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
Permit issued this the 15`b day of April, 2010
NORTH CAROLINA ENVIRONMENTAL MANAGEMENT COMMISSION
Aolepq. Sullins, Director
Divi 'on of Water Quality
By Authority of the Environmental Management Commission
Permit Number WQ0034603
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Permit No. WQ0034603 Conjunctive Reclaimed Water Systdm
Novanis Vaccines & UiagnosGcs, hw. fiprll 1�, 206
Novartis Vaccines & Diagnostics Facility Wake County
ENGINEERING CERTIFICATION
❑ Partial ❑ Final
In accordance with 15A NCAC 02T .0 116, I,
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
City State
NC PE Seal
nature & 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:
1630 MAIL 66KVi(-L CEN 1*hK
RALEIGH, NORTH CAROLINA 27699-1636
By Courier/Special Deliverx:
ZiZa CAPITAL13OULEVi-UW
RALEIGH, NORTH CAROLINA 27604

ATTACHM ':NT B - APPROVED UTILIZATION SI AND LIMIITATIONS Permit Number: WQ0034603 Version: 1.0
Novartis Va . Nines & Diagnostics, Inc. — Novartis Vacc : , & Diagnostics Facility
IRRIGATION AREA INFORMA '
Zone Owner County Latitude
1 Novar. Vaccines & Diagnostics, Inc. Wake 35°39'10' 1 '
I
L.
Total
1. Irrigati . shall be limited to the needs of the cover cropF
2. Irrigati: with reclaimed water shall be conducted only the months of April — November.
COOLING TOWER UTILIZATION
Zone Owner County Latitude .�uitude
2 Novarti, Vaccines & Diagnostics, Inc. Wake 3539'10" I >TO1"
i
Totals
WQ0034603 ' ;rsion 1.0 Attachment B ge 1 of t
i
APPLICATION LIMITATIONS
itude
Net
Acreage
Dominant
Soil Series
parameter Permitted Hourly Seasonal
Precipitation Rate Restrictions 2
Uni S
2'01"
13.75
Mat loam
01284 01284 - Application Surface Irrigation 0.20 April - Nov
in/ -
13.75
1. Irrigati . shall be limited to the needs of the cover cropF
2. Irrigati: with reclaimed water shall be conducted only the months of April — November.
COOLING TOWER UTILIZATION
Zone Owner County Latitude .�uitude
2 Novarti, Vaccines & Diagnostics, Inc. Wake 3539'10" I >TO1"
i
Totals
WQ0034603 ' ;rsion 1.0 Attachment B ge 1 of t
i