HomeMy WebLinkAboutNCGNE1501_Application_20211004FOR AGENCY USE ONLY
NCGNE 1 5 O 1 RECEIVED
Assigned to: Cw.irSo✓tt
ARO FRO MRO (5 WARO WIRO WSRO OCT 0 4 2021
DEAR -LAND QUALITY
STORMWATER PERMITTING
Division of Energy, Mineral, and Land Resources
National Pollutant Discharge Elimination System
No Exposure Certification for Exclusion
NCGNE0000
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. Industrial materials or activities include, but are not limited to:
• material handling equipment or activities, • by-products,
• industrial machinery, • final products, or
• raw materials, • waste products.
• intermediate 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 industrial materials stored in the following container types, provided
the containers are not deteriorated and do not leak:
• drums, • tanks, and
• barrels, • similar containers.
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rescinded, your facility must continue to abide by the terms and conditions of the current permit.
A No Exposure Certification must be provided for each facility qualifying forthe no exposure exclusion. Additionally,
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 forthe 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 Certification has no expiration date but must be self -recertified at least
annually. Please look for information about recertification under the No Exposure section on this page:
https://deg.nc.gov/about/divisions/energy-mi neral-land-resources/npdes-no-exposure.
Directions: Print or type all entries on this application form. Send the original, signed application to: NCDEMLR
Stormwater Program, 1612 MSC, Raleigh, NC 27699-1612. The submission of this form does not guarantee
exclusion from NPDES stormwater permitting. Prior to exclusion from NPDES stormwater permitting a site
inspection will be conducted.
Page 1 of 5
1. Owner/Operator (to whom all permit correspondence will be mailed):
Name of legal organizational entity:
Legally responsible person (as signed in Item 7 below):
Audentes Therapeutics, Inc.
Pablo Guzman
Street address:
City:
State
Zip Code
6074 Enterprise Drive
Sanford
NC
27330
Telephone number:
Email address:
323-514-8278
pguzman@audentestx.com
Type of Ownership:
Government
❑ County ❑ Federal ❑ Municipal ❑State
Non -government
0 Business (If ownership is business, a copy of NCSOS report must be included with this application)
❑ Individual
2. Industrial Facility (facility requesting exclusion):
Facility name:
Facility environmental contact:
Audentes Therapeutics
Tim Daly
Street address:
Telephone number:
6074 Enterprise Park Drive
919-614-5854
Email address:
tdaly@audentestx.com
City
County
State
Zip Code
Sanford
Lee
NC
27330
Latitude of entrance: 35.562510
Longitude of entrance:-79.155346
Parcel Identification Number (PIN):
965539620500
Date operation began:
Standard Industrial Classification (SIC) Code:
January 2022 (proposed)
2836
Brief description of the types of industrial activities and products produced at this facility:
Pharmaceutical company with manufacturing and QC laboratory facilities producing genetic medicines
3. Consultant (if applicable):
Name of consultant:
Consulting firm:
John Carroll
Trinity Consultants, Inc.
Street address:
City:
State and zip code:
1 Copley Parkway, Suite 205
Morrisville
NC 27560
Telephone number:
Email address:
I
919-500-9426
jcarroll@trinityconsultants.com
4. Exposure Checklists
Are any of the following materials or activities exposed to precipitation, now or in the foreseeable future? If you
answer "Yes" to any of these items, you are not eligible for the no exposure exclusion.
Using, storing, or cleaning industrial machinery or equipment, and areas where residuals from
using, storing, or cleaning industrial machinery or equipment remain and are exposed to
stormwater
❑ Yes 0 No ❑ N/A
Materials or residuals on the ground or in stormwater inlets from spills/leaks
❑ Yes ❑ No El N/A
Materials or products from past industrial activity
❑ Yes El No ❑ N/A
Material handling equipment (except adequately maintained vehicles)
❑ Yes El No ❑ N/A
Page 2 of 5
Materials or products during loading/unloading or transporting activities
El Yes El No ❑ N/A
Materials or products stored outdoors (except final products intended for outside use [e.g., new
cars] where exposure to stormwater does not result in the discharge of pollutants)
❑ Yes El No ❑ N/A
Materials contained in open, deteriorated, non -sealed', or leaking storage drums barrels, tanks,
and similar containers
❑ Yes 0 No ❑ N/A
Materials or products handled/stored on roads or railways owned or maintained by the discharger
❑Yes 0 No ❑ N/A
Final products that would be mobilized in stormwater discharges (e.g., rock salt)
❑ Yes El No ❑ N/A
Waste material (except waste in covered, non -leaking containers [e.g., dumpsters])
❑ Yes 0 No ❑ N/A
Application or disposal of process wastewater (unless otherwise permitted)
❑Yes El No ❑ N/A
Particulate matter or visible deposits of residuals from roof stacks and/or vents not otherwise
regulated (i.e. under an air quality control permit) and evident in the stormwater outflow
❑ Yes El No ❑ N/A
Empty containers that previously contained materials that are not properly stored (i.e., not closed
and stored upside down to prevent precipitation accumulation)
❑ Yes El No ❑ N/A
For any exterior ASTs, as well as drums, barrels, tanks and similar containers stored outside, has
the facility had any releases in the past three (3) years?
❑ Yes El No ❑ N/A
'Sealed means banded or otherwise secured and with locked or non -operational taps or valves.
Above Ground Storage Tanks (ASTs) and Secondary Containment
if you answer "No" to any of the following items, you are not eligible for the no exposure exclusion.
Are exterior ASTs or piping free of rust, damaged or weathered coating, pits, or deterioration, or
ElYes ❑ No ❑ N/A
evidence of leaks?
Is secondary containment provided for all exterior ASTs? If so, is it free of any cracks, holes, or
El Yes ❑No ❑ N/A
evidence of leaks, and are drain valves maintained locked shut?
Is secondary containment provided for single above ground storage containers (including drums,
❑Yes ❑No El N/A
barrels, etc.) with a capacity of more than 660-gallons?
Is secondary containment provided for above ground storage containers stored in close proximity
El Yes ❑No 0 N/A
to each other with a combined capacity of more than 1,320 gallons?
Is secondary containment provided for Title III Section 313 Superfund Amendments and
❑Yes ❑ No El N/A
Reauthorization Act (SARA) water priority chemicals?
Is secondary containment provided for hazardous substances designated in 40 CFR §116?
ElYes El No ❑ N/A
Are release valves on all secondary containment structures locked?
❑Yes [I No El N/A
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.
Are vehicles used in material handling in disrepair and/or leaking fluid?
❑ Yes 0 No ❑ N/A
Does this facility store used, recycled, or otherwise reclaimed pallets outside?
❑Yes El No ❑ N/A
Does this facility have coal piles on site?
❑ Yes El No ❑ N/A
Does this facility store other fuel sources outside in piles, such as wood chips, sawdust, etc.?
❑ Yes El No ❑ N/A
Page 3 of 5
Does this facility have air emissions associated with industrial activity (e.g., degreasing operations, El Yes 0 No ❑ N/A
plating, painting, or metal finishing)?
If yes:
Describe the industrial activity:
Natural gas -fired boilers, hot water heaters, non -contact cooling towers, venting of process reactors
Are those emissions permitted by an Air Quality Permit? DYes E]No
Please specify: The facility is applying to NC DAQ for registration status
S. Other Facility Conditions (check all that apply and explain accordingly):
❑ This facility has other NPDES permits.
If checked, list the permit numbers for all current NPDES permits:
❑ This facility has Non -Discharge permits (e.g. recycle permit).
If checked, list the permit numbers for all current Non -Discharge permits:
❑ This facility stores hazardous waste in the 100-year floodplain.
If checked, describe how the area is protected from flooding:
El This facility is a (mark all that apply)
O Hazardous Waste Generation Facility
❑ Hazardous Waste Treatment Facility
❑ Hazardous Waste Storage Facility
❑ Hazardous Waste Disposal Facility
If checked, indicate:
• Kilograms of waste generated each month: Less than 1,000 kg
• Type(s) of waste: D001 (ignitable), D002 (corrosive), F003 (spent non -halogenated solvents)
• How material is stored: In approved containers
• Where material is stored: Designated areas inside building
• Number of waste shipments per year: TBD
• Name of transport/disposal vendor: Clean Harbors (proposed)
• Transport/disposal vendor EPA ID: TBD
• Vendor address: TBD
❑ This facility is located on a Brownfield or SUPERFUND site.
If checked, briefly describe the site conditions:
❑ This facility is located on Native American Lands.
6. Required Items (Application will be returned unless all of the following items have been included):
0 Copy of most recent Annual Report to the NC Secretary of State (if applicable)
0 This completed application and any supporting documentation
El Copy of county map or USGS quad sheet with the location of the facility clearly marked
Page 4 of 5
7. Applicant Certification
North Carolina General Statute 143-215.613 (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 ... shall be guilty of a Class 2 misdemeanor which may include a fine not
to exceed ten thousand dollars ($10,000). I hereby request exclusion from NPDES stormwater permitting.
Under penalty of law, I certify that:
0 1 am the person responsible for the industrial activity, for satisfying the requirements of this exclusion, and for any civil
or criminal penalties incurred due to violations of this exclusion.
O I have read and understand the eligibility requirements for claiming a condition of "no exposure" and obtaining an
exclusion from NPDES stormwater permitting.
0 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)).
i7 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 applicable, 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 recertifications on file at the facility.
17 I understand that in the event that the site no longer qualifies for a No Exposure Exclusion that I must obtain coverage
under an NPDES permit prior to any point source discharge of stormwater from the facility.
I] The information submitted in this NOI is, to the best of my knowledge and belief, true, accurate, and complete based on
my inquiry of the person or persons who manage the system, or those persons directly responsible for gathering the
information.
Printed Name of Person Signing: Pablo Guzman
Title: Sr. Manager, Facil' 'es and Engineering
- - q Z Z -'2
Signature of pplica Date Signed
Mail the entire package to: DEMLR— Stormwater Program
Department of Environmental Quality
1612 Mail Service Center
Raleigh, NC 27699-1612
Page 5 of 5
_.t BUSINESS CORPORATION ANNUAL REPORT
■
� z
10-2017
NAME OF BUSINESS CORPORATION: Audentes Therapeutics, Inc.
SECRETARY OF STATE ID NUMBER: 1942231 STATE OF FORMATION: DE
REPORT FOR THE FISCAL YEAR END: 12/31/2020
SECTION A: REGISTERED AGENT'S INFORMATION
1. NAME OF REGISTERED AGENT: Corporation Service Corn
2. SIGNATURE OF THE NEW REGISTERED AGENT:
E - Filed Annual
Report
1942231
❑X Changes
SIGNATURE CONSTITUTES CONSENT TO THE APPOINTMENT
3. REGISTERED AGENT OFFICE STREET ADDRESS & COUNTY 4. REGISTERED AGENT OFFICE MAILING ADDRESS
2626 Glenwood Ave Ste 550 2626 Glenwood Ave Ste 550
Raleigh, NC 27608 Wake County
Raleigh, NC 27608
SECTION B: PRINCIPAL OFFICE INFORMATION
1. DESCRIPTION OF NATURE OF BUSINESS: Specific purpose clause Therapy company focusing on rare neuromuscular disease
2. PRINCIPAL OFFICE PHONE NUMBER: (224) 205-5875 3. PRINCIPAL OFFICE EMAIL: Privacy Redaction
4. PRINCIPAL OFFICE STREET ADDRESS 5. PRINCIPAL OFFICE MAILING ADDRESS
600 California St 17th Floor
San Francisco, CA 94108
600 California St 17th Floor
San Francisco, CA 94108
6. Select one of the following if applicable. (Optional see instructions)
❑ The company is a veteran -owned small business
❑ The company is a service -disabled veteran -owned small business
SECTION C: OFFICERS (Enter additional officers in Section E.)
NAME: Natalie Holles
TITLE: President
ADDRESS:
600 California Street 17th FL
San Francisco, CA 94108
NAME: Megan Baierlein NAME: Thomas Soloway
TITLE: Secretary TITLE: Treasurer
ADDRESS:
600 California Street 17th FL
San Francisco, CA 94108
ADDRESS:
600 California Street 17th FL
San Francisco, CA 94108
SECTION D: CERTIFICATION OF ANNUAL REPORT. Section D must be completed in its entirety by a person/business
entity.
Megan Baierlein 4/14/2021
SIGNATURE DATE
Form must be signed by an officer listed under Section C of this form.
Megan Baierlein Secretary
Print or Type Name of Officer Print or Type Title of Officer
This Annual Report has been filed electronically.
MAIL TO: Secretary of State, Business Registration Division, Post Office Box 29525, Raleigh, NC 27626-0525
Site Location
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• File an Annual Report/Amend an Annual Report • 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
Business Corporation
Legal Name
Audentes Therapeutics, Inc.
Information
SOsld: 1942231
Status: Current -Active O
Date Formed: 1/28/2020
Citizenship: Foreign
State of Incorporation: DE
Fiscal Month: December
Annual Report Due Date: April 15th
Currentgnnuat Report Status:
Registered Agent: Corporation Service Company
Addresses
Reg Office
2626 Glenwood Ave Ste 550
Raleigh, NC 27608
Officers
Secretary
Megan Baierlein
600 California Street 17th FL
San Francisco CA 94108
Stock
Reg Mailing
2626 Glenwood Ave Ste 550
Raleigh, NC 27608
President
Natalie Holles
600 California Street 17th FL
San Francisco CA 94108
Mailing
600 California St 17th Floor
San Francisco, CA 94108
Treasurer
Thomas Soloway
600 California Street 17th FL
San Francisco CA 94108
Principal Office
600 California St 17th Floor
San Francisco, CA 94108
AUDENTES>o--
An Astellas Company
September 27, 2021
Ms. Suzanne McCoy
Division of Energy, Mineral, and Land Resources
NC Department of Environmental Quality
1612 Mail Service Center
Raleigh, NC 27699-1612
Re: No Exposure Certification Application
Audentes Therapeutics — Sanford Facility
Sanford, Lee County, NC
Dear Ms. McCoy,
REEF -WED
OCT 0 4 2021
DENR-LAND QUALITY
STORMWATER PERMITTING
Audentes Therapeutics (Audentes) of Sanford is a new facility submitting the attached application for no exposure
certification. The facility is a pharmaceutical manufacturer producing genetic medicines. All industrial activities,
material storage, and operations will occur inside the plant building or otherwise will not be exposed to
stormwater. In addition, all wastewater discharges, including cooling tower blowdown, will be directed to the
process/sanitary sewer. Operations are proposed to commence in January 2022.
If you have any questions regarding this application for no exposure certification, please contact Tim Daly at
(919) 614-5854 or John Carroll of Trinity Consultants at (919) 500-9426.
Sincerely,
Pablo Guzman
Senior Manager, Facilities & Engineering
Audentes Therapeutics
cc: Tim Daly PE, Audentes Therapeutics
John Carroll PE, Trinity Consultants
About Audentes Therapeutics, Inc., an Astellas Company
Audentes Therapeutics, Inc., an Astellas company, is an AAV-based genetic medicines company focused on developing and
commercializing innovative therapies that can offer transformative benefits to patients. In addition to its gene therapy portfolio targeting
serious rare neuromuscular diseases, Audentes is leveraging Astellas' global resources, industry leadership in immune biology, and deep
scientific expertise to expand its reach and deliver valuable new genetic medicines to patients around the world.