NCGNE1436_Application_20201110

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Division of Energy, Mineral and Land Resources
Land Quality Section
National Pollutant Discharge Elimination System
NO EXPOSURE CERTIFICATION for Exclusion
Environmental Quality NCGNE0000
FOR AGENCY USE ONLY
Date Received
Year
Month
Day
Certificate of Coverage
N E to
P-p-Z,
National Pollutant Discharge Elimination System application for exclusion from a Stormwater Permit based
on NO EXPOSURE:
Submission of this No Exposure Certification constitutes notification that your facility does not require a
permit for stormwater discharges associated with industrial activity in the State of North Carolina because
it qualifies for a no exposure exclusion. A condition of no exposure at an industrial facility means all
industrial materials and activities are protected by a storm resistant shelter (with some exceptions) to
prevent exposure to rain, snow, snowmelt, and/or runoff.
For permitted facilities in North Carolina, DEMLR must approve your application for No
Exposure Certification before this exclusion is effective. Until you are issued a No
Exposure Certification and your NPDES permit is rescinded, your facility must continue
to abide by the terms and conditions of the current permit.
Industrial materials or activities include, but are not limited to: material handling equipment or activities,
industrial machinery, raw materials, intermediate products, by-products, final products, or waste products.
Material handling activities include the storage, loading and unloading, transportation, or conveyance of
any raw material, intermediate product, final product or waste product. A storm resistant shelter is not
required for the following industrial materials and activities: drums, barrels, tanks, and similar containers
that are tightly sealed, provided those containers are not deteriorated and do not leak. "Sealed" means
banded or otherwise secured and with locked or non -operational taps or valves; adequately maintained
vehicles used in material handling; and final products, other than products that would be mobilized in
stormwater discharges (e.g., rock salt).
A No Exposure Certification must be provided for each facility qualifying for the no exposure exclusion. In
addition, the exclusion from NPDES permitting is available on a facility -wide basis only —not for individual
outfalls. If any industrial activities or materials are, or will be, exposed to precipitation, the facility is not
eligible for the no exposure exclusion. By signing and submitting this No Exposure Certification form, you
certify that a condition of no exposure exists at this facility or site and are obligated to comply with the
terms and conditions of 40 CFR 122.26(g).
If approved, your conditional No Exposure Exclusion has no expiration date
BUT MUST BE self re -certified at least annually.
Please look for information about re -certification under the No Exposure section on this page:
https://deg. nc.gov/about/divisions/energy-mineral-land-resources/energy-mineral-land-permits/stormwater-
For questions, please contact the DEMLR Regional Office for your area. (See page 6)
(Please print or type)
1) Mailing address of ownerloperator (address to which all certification correspondence will be mailed):
Name Novartis Gene Therapies
Contact
Street Address
City
Telephone No.
Stefan P. Wawzyniecki
2512 S. Tricenter Blvd
Durham
984 243-9121
Page 1 of 7
State NC
Fax:
ZIP Code 27713
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NCGNE0000 No Exposure Certification
2) Location of facility producing discharge:
Facility Name Novartis Gene Therapies
Facility Contact
Street Address
City
County
Telephone No.
Stefan P. Wawzyniecki
2512 S. Tricenter Blvd
Durham
Durham
984 243-9121
3) Physical location information:
State NC ZIP Code 27713
Fax:
Please provide a narrative description of how to get to the facility (use street names, state road numbers, and
distance and direction from a roadway intersection). 1-40w to exit 2798, onto NC-147N. Take the Corwallis Rd. exit. Travel 1.6 miles
on Cornwallis Rd. and Tricenter Blvd will be on your left. 2512 S. Tricenter Blvd is approximately 600 feet down on your right.
(A copy of a map with the facility clearly located on it should be included with the certification application.)
4) Is the facility located on Native American Lands?® Yes No
5) Is this a Federal facility? ® Yes A No
6) Latitude 35055'26.7° N Longitude 78°52'58.9" w (deg., min., seconds)
7) This NPDES No Exposure Exclusion application applies to which of the following:
El New or Proposed Facility
® Existing
Date operation is to begin
Date operation began May 2020
® Renewal of existing No Exposure Certification Certification No.: NCGNE
8) Was this facility or site ever covered under an NPDES Stormwater Permit? ® Yes A No
If yes, what is the NPDES Permit Number?,
9) Standard Industrial Classification:
Provide the 4-digit Standard Industrial Classification Code (SIC Code) that describes the primary industrial
activity at this facility
SIC Code: 2 8 3 6
10) Provide a brief description of the types of industrial activities and products produced at this facility:
Pharmaceutical aene therapy manufacturina. No external industrial activities. There is a
loading dock for deliveries and 3 sealed self-contained trash/recycling compactors.
11) Does this facility have any Non -Discharge permits (ex: recycle permits)?
ANo
p Yes
If yes, list the permit numbers for all current Non -Discharge permits for this facility:
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NCGNE0000 No Exposure Certification
Exposure Checklists (12. - 14.)
12) Are any of the following materials or activities exposed to precipitation, now or in the foreseeable
future? (Please check either "Yes" or "No.") If you answer "Yes" to any of these items, you are not
eligible for the no exposure exclusion.
a. Using, storing, or cleaning industrial machinery or equipment, and areas where 0 Yes `r No 0 N/A
residuals from using, storing or cleaning industrial machinery or equipment
remain and are exposed to stormwater
b. Materials or residuals on the ground or in stormwater inlets from spills/leaks 0 Yes KNo in N/A
c. Materials or products from past industrial activity
0 Yes XNo
0 N/A
d. Material handling equipment (except adequately maintained vehicles)
0 Yes �No
0 N/A
e. Materials or products during loading/unloading or transporting activities
0 Yes No
0 N/A
f. Materials or products stored outdoors (except final products intended for outside
0 Yes No
0 N/A
use [e.g., new cars] where exposure to stormwater does not result in the
discharge of pollutants)
g. Materials contained in open, deteriorated or leaking storage drums, barrels,
0 Yes j No
O N/A
tanks, and similar containers
I
h. Materials or products handled/stored on roads or railways owned or maintained
0 Yes No
❑ N/A
by the discharger
i. Waste material (except waste in covered, non -leaking containers [e.g.,
0 Yes No 0 N/A
dumpsters])
j. Application or disposal of process wastewater (unless otherwise permitted)
0 Yes No 0 N/A
k. Particulate matter or visible deposits of residuals from roof stacks and/or vents
0 Yes No 0 N/A
not otherwise regulated (i.e., under an air quality control permit) and evident in the
stormwater outflow
I. Empty containers that previously contained materials that are not properly stored
0 Yes *o 0 N/A
(i.e., not closed and stored upside down to prevent precipitation accumulation)
m. For any exterior ASTs, as well as drums, barrels, tanks, and similar containers
0 Yes No 0 N/A
stored outside, has the facility had any releases in the past three (3) years?
13) Above Ground Storage Tanks (ASTs): If you answer "No" to any of the following items, you are not
eligible for the no exposure exclusion.
a. Are exterior ASTs or piping free of rust, damaged or weathered coating, pits, or Yes 0 No 0 N/A
deterioration, or evidence of leaks?
b. Is secondary containment provided for all exterior ASTs? If so, is it free of any Yes ❑ No ❑ N/A
cracks, holes, or evidence of leaks, and are drain valves maintained locked
shut?
14) Secondary Containment: If you answer "No" to any of the following items, you are not eligible for the
no exposure exclusion.
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NCGNE0000 No Exposure Certification
a. Is secondary containment provided for single above ground storage containers Yes O No in N/A
(including drums, barrels, etc.) with a capacity of more than 660-gallons?
b. Is secondary containment provided for above ground storage containers stored Yes p No ❑ N/A
in close proximity to each other with a combined capacity of more than 1,320- r
gallons?
c. Is secondary containment provided for Title III Section 313 Superfund [ Yes ® No C N/A
Amendments and Reauthorization Act (SARA) water priority chemicals*?
d. Is secondary containment provided for hazardous substances** designated in 1WYes ® No ® N/A
40 CFR §116? //
e. Are release valves on all secondary containment structures locked? Yes in No p N/A
15) Hazardous Waste:
a. Is this facility a Hazardous Waste Treatment, Storage, or Disposal Facility? ®Yes �(No ® N/A
b. Is this facility a Small Quantity Generator (less than 1000 kg. of hazardous Yes ® No ® N/A
waste generated per month) of hazardous waste?
c. Is this facility a Large Quantity Generator (1000 kg. or more of hazardous waste ® Yes 1 No ® N/A
generated per month) of hazardous waste? r
If you answered yes to questions b. or c., please provide the following information:
Type(s) of
waste: Corrosives (acids and bases), ignitables (ethanol, isopropanol), trypan blue, hydrogen peroxide
vendor:
How Is material stored: In drums and bins on secondary containment in a locked waste room
Where is material stored: Inside facility in a locked room on secondary containment
How many disposal shipments per year: -12
Name of transport / disposal
Triumvirate Environmental, Inc.
Vendor address: 1916 Garner Station Blvd, Raleigh, NC 27603
Footnotes to Questions 14) c. & d.
*Note that amounts below the 660-gallon (single) and 1,320-gallon (combined) bulk storage minimums require
secondary containment. However, some exceptions may be made for de minimis amounts of certain substances,
and/or other qualifiers, as described in the exemptions from reporting requirements of Title III SARA 313 in 40 CFR
§372.38.
**Note that amounts below the 660-gallon (single) and 1,320-gallon (combined) bulk storage minimums require
secondary containment. However, some exceptions may be made for amounts less than the Reportable
Quantities of the hazardous substances listed in 40 CFR §117.3.
16) Other information: If you answer "Yes" to any of the following items, you might not be eligible for the
no exposure exclusion. A more in-depth evaluation of the site circumstances may be required.
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NCGNE0000 No Exposure Certification
a. Does your facility store used, recycled, or otherwise reclaimed pallets outside?
Yes in No 13 N/A
b. Does your facility have coal piles on site?
p Yes �No ® N/A
c. Does your facility store other fuel sources outside in piles, such as wood chips,
® Yes No in N/A
sawdust, etc.?
d. Does your facility have air emissions associated with its industrial activity (e.g.,
0 Yes XNo ® N/A
degreasing operations, plating, painting and metal finishing)? If so, describe the
industrial activity:
e. If you answered yes to d., are those emissions permitted by an Air Quality
® Yes ® No XN/A
Permit? Please specify:
f. Please list any other environmental program permits (federal, state, etc.) not
specified earlier in this application (such as Hazardous Waste Permits, etc.):
Permit: NCR000174946 Program: Hazardous Waste SQG
5004 Program: Local Industrial Wastewater Discharge Permit
Permit:
Permit: Program:
Permit: Program:
Permit: Program:
Permit: Program:
Permit: Program:
ook-noNf �or
SNoreA C,n c, eke,&& ke lA ,pQ�
o.h awIll No c-n fas„« Ao r L-,a�tr.
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NCGNE0000 No Exposure Certification
17) Certification:
I certify under penalty of law that I have read and understand the eligibility requirements for claiming a condition of "no
exposure" and obtaining an exclusion from NPDES stormwater permitting.
I certify under penalty of law that there are no discharges of stormwater contaminated by exposure to industrial activities or
materials from the industrial facility or site identified in this document (except as allowed under 40 CFR 122.26(g)(2)).
I understand that I am obligated to maintain no exposure conditions and complete a Self -Recertification form at least once
each year, and if requested, provide this certification to the operator of the local municipal separate storm sewer system
(MS4) into which the facility discharges (where applicable). I understand that I must allow the North Carolina Division of
Energy, Mineral, and Land Resources, or MS4 operator where the discharge is into the local MS4, to perform inspections
to confirm the condition of no exposure and to make such inspection reports publicly available upon request. I understand I
must keep a copy of annual re -certifications on file at the facility.
In the event that the site no longer qualifies for a No Exposure Exclusion, I understand that I must obtain coverage under
an NPDES permit prior to any point source discharge of stormwater from the facility. Additionally, I certify under penalty of
law that this document and all attachments were prepared under my direction or supervision in accordance with a system
designed to assure that qualified personnel properly gathered and evaluated the information submitted. Based on my
inquiry of the person or persons who manage the system, or those persons directly responsible for gathering the
information, the information submitted is to the best of my knowledge and belief true, accurate and complete. I am aware
that there are significant penalties for submitting false information, including the possibility of fine and imprisonment for
knowing violations.
I certify that I am familiar with the information contained in this application and that to the best of my knowledge and belief
such information is true, complete, and accurate.
Printed Name of Person Signing: Stefan P. wawzyniecki
Title: Sr. Environmental Specialist
(Signature df Applicant)
qOc.� ZG2o
(Date Signed)
Please note: This application for the No Exposure Exclusion is subject to approval by the NCDEQ
Regional Office prior to issuance. The Regional Office may inspect your facility for compliance
with no exposure conditions prior to that approval. The Regional Office may also inspect your
facility at any time in the future for compliance with the No Exposure Exclusion.
North Carolina General Statute 143-215.6 B(i) provides that:
Any person who knowingly makes any false statement, representation, or certification in any application, record, report, plan, or other
document filed or required to be maintained under this Article or a rule implementing this Article; or who knowingly makes a false
statement of a material fact in a rulemaking proceeding or contested case under this Article; or who falsifies, tampers with, or knowingly
renders inaccurate any recording or monitoring device or method required to be operated or maintained under this Article or rules of the
[Environmental Management] Commission implementing this Article shall be guilty of a Class 2 misdemeanor which may include a fine
not to exceed ten thousand dollars ($10,000).
There is currently no fee for a No Exposure Exclusion.
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NCGNE0000 No Exposure Certification
Final Checklist
This application should include the following items:
MThis completed application and all supporting documentation.
WA map with the location of the facility clearly marked.
❑ If the site currently has an NPDES Stormwater Permit, be sure to indicate the permit number in Question 8.
Mail the entire package to:
DEMLR - Stormwater Program
Dept. of Environmental Quality
1612 Mail Service Center
Raleigh, North Carolina 27699-1612
Note
The submission of this document does not guarantee the issuance of a No Exposure Exclusion.
For questions, please contact the DEMLR Regional Office for your area.
DEMLR Regional Office Contact Information:
Asheville Office ......
[phone]
Fayetteville Office ...
[phone]
Mooresville Office ...
[phone]
Raleigh Office ........
[phone]
Washington Office
... [phone]
Wilmington Office ...
[phone]
Winston-Salem ......
[phone]
Central Office .........
[phone]
Page 7of7
SWU-NCGNE Last revised 9/28/2016

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RE: DEMLR: Stormwater No Exposure Certification
To: DEMLR -- Stormwater Program; NCDEQ
1612 Mail Service Center
Raleigh, NC 27699-1612
From: Novartis Gene Therapies
2512 S. Tricenter Blvd
Durham, NC 27713
To whom it may concern:
RECEIVED
NOV 10 2020
DENR-LAND QUALITY
STORMWATER PERMITTING
Please find attached a completed application and all supporting documentation for the NPDES No
Exposure Certification (NCGNE0000). This facility's materials and activities are protected to
prevent exposure to rain, snow, snowmelt, and/or runoff.
If you have any questions or comments pertaining to this application, please do not hesitate to
reach out with any inquiries. Thank you.
Respectfully,
, _., g; Z /
Stefan Wawzyniecki, CHMM
Sr. Environmental Specialist
Z1-1
77:�j —
[e-mail]
M: 860-967-8291
O: 984-243-9121
Novartis Gene Therapies
2512 S. Tri-Center Blvd
Durham, NC 27713
Gene Therapies
J) NOVARTIS I Reimagining Medicine

North Carolina Secretary of State Search Results
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• Upload a PDF Filing • Order a Document Online • Add Entity to My Email Notification List • View
Filings • Print a Pre -Populated Annual Report form • Print an Amended a Annual Report form
i
Business Corporation
Legal Name
NOVARTIS LTD.
Information
Sosld: 0398093
Status: Multiple O
Date Formed: 6/4/1996
Citizenship: Foreign
State of Incorporation: DE
Fiscal Month: December
Annual Report Due Date: April 15th
Registered Agent: The Prentice -Hall Corporation System, Inc.
Addresses
Mailing
101 Park Avenue
New York, NY 10178
Officers
Stock
Reg Office
327 Hillsborough Street
Raleigh, NC 27603
Reg Mailing
327 Hillsborough Street
Raleigh, NC 27603
https://www. sosnc.gov/online_services/search/Business_Registration_Results 11 / 17/2020

North Carolina Secretary of State Search Results
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Business Corporation
Legal Name
Novartis Pharmaceuticals Corporation
Prev Legal Name
Sandoz Pharmaceuticals Corporation
Prev Legal Name
Sandoz, Inc.
Prev LegaL Name
Sandoz -wander, Inc.
Information
Sosld: 0128923
Status: Current -Active O
Date Formed: 8/11/1969
Citizenship: Foreign
State of Incorporation: DE
Fiscal Month: December
Annual Report Due Date: April 15th
Registered Agent: Corporation Service Company
Addresses
Reg Office Reg Mailing Mailing
2626 Glenwood Avenue, Suite 550 2626 Glenwood Avenue, Suite 550 59 Route 10
Raleigh, NC 27608 Raleigh, NC 27608 East Hanover, NJ 07936
Officers
President Secretary Chief Financial Officer
FABRICE CHOURAQUI Thomas Kendris John McKenna
59 Route 10 59 Route 10 6201 South Freeway
East Hanover NJ 07936 East Hanover NJ 07936 Fort Worth TX 76134
Stock
CLass: 99 SEE CERT
Shares: 0
Par Value 0
Principal Office
59 Route 10
East Hanover. NJ 07936
https://www.sosnc.gov/online_services/search/Business_Registration_Results 11 / 17/2020