HomeMy WebLinkAboutNCGNE1549_Application_20220822FOR
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Division of Energy, Mineral, and Land Resources
National Pollutant Discharge Elimination System
No Exposure Certification for Exclusion
N CG N E0000
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,
• barrels,
• tanks, and
• similar containers.
For new facilities, applicants should apply no earlier than 60 days before the start of operation. This will allow
DEMLR staff to verify conditions during active operation. For facilities that already have an industrial stormwater
permit in North Carolina, DEMUR 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 Until you are issued a No Exposure Certification and your NPDES permit is rescinded, your facility must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 for the 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 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).
For new facilities, applicants should not apply more than 60 days before the start of operation date. This
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-mineral-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 6
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):
Exela Pharma Sciences, LLC
Mr. Brian Eckert
Street address:
City:
State
Zip Code
1245 Blowing Rock Boulevard
Lenoir
NC
28645
Telephone number:
Email address:
630-688-3998
beckert@exela.us
Type of Ownership:
Government
❑ County ❑ Federal ❑ Municipal ❑ State
Non -government
IN Business (If ownership is business, a copy of NCSOS report must be included with this application)
❑ Individual (NCSOS No. 1051484)
2. Industrial Facility (facility requesting exclusion):
Facility name:
Facility environmental contact:
Exela Pharma Sciences, LLC-MICHELLE Facility
Mr. Brian Eckert
Street address:
Telephone number:
1325 William White Place Northeast
630-688-3938
Email address:
beckert@exela.us
City
County
State
Zip Code
Lenoir
Caldwell
North Carolina
28645
Latitude of entrance: 35.945249
Longitude of entrance:-81.532051
Parcel Identification Number (PIN):
09-148-1-38
Date operation began:
Standard Industrial Classification (SIC) Code:
Prior to July 2022
2834
Brief description of the types of industrial activities and products produced at this facility:
Manufacture of sterile injectable solutions and laboratory testing operations
3. Consultant (if applicable):
Name of consultant:
Consulting firm:
Jeff J. Cook
ECS Southeast LLP
Street address:
City:
State and zip code:
2580 Northeast Expressway
Atlanta
30345
Telephone number:
Email address:
470-510-9569
jcook@ecslimited.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 CC No ❑ N/A
Materials or residuals on the ground or in stormwater inlets from spills/leaks
❑ Yes IN No ❑ N/A
Materials or products from past industrial activity
❑ Yes N No ❑ N/A
Material handling equipment (except adequately maintained vehicles)
❑ Yes X No ❑ N/A
Page 3 of 6
Materials or products during loading/unloading or transporting activities
❑ Yes 04 No ❑ N/A
Materials or products stored outdoors (except final products intended for outside use [e.g., new
❑ Yes IN No ❑ N/A
cars] where exposure to stormwater does not result in the discharge of pollutants)
Materials contained in open, deteriorated, non -sealed', or leaking storage drums barrels, tanks,
❑ Yes X No ❑ N/A
and similar containers
Materials or products handled/stored on roads or railways owned or maintained by the discharger
❑ Yes ❑ No ® N/A
Final products that would be mobilized in stormwater discharges (e.g., rock salt)
❑ Yes ❑ No IN N/A
Waste material (except waste in covered, non -leaking containers [e.g., dumpsters])
❑ Yes ® No ❑ N/A
Application or disposal of process wastewater (unless otherwise permitted)
❑ Yes 0 No ❑ N/A
Particulate matter or visible deposits of residuals from roof stacks and/or vents not otherwise
❑ Yes ❑ No IN N/A
regulated (i.e. under an air quality control permit) and evident in the stormwater outflow
Empty containers that previously contained materials that are not properly stored (i.e., not closed
❑ Yes P9 No ❑ N/A
and stored upside down to prevent precipitation accumulation)
For any exterior ASTs, as well as drums, barrels, tanks and similar containers stored outside, has
❑ Yes ❑ No I$ N/A
the facility had any releases in the past three (3) years?
'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
p Yes ❑ No X] N/A
evidence of leaks?
Is secondary containment provided for all exterior ASTs? If so, is it free of any cracks, holes, or
p Yes ❑ No [X N/A
evidence of leaks, and are drain valves maintained locked shut?
Is secondary containment provided for single above ground storage containers (including drums,
El Yes ❑ No 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
❑ Yes ❑ No X 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 ®N/A
Reauthorization Act (SARA) water priority chemicals?
Is secondary containment provided for hazardous substances designated in 40 CFR §116?
❑ Yes ❑ No ® N/A
Are release valves on all secondary containment structures locked?
❑ Yes O No EX 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 ® No ❑ N/A
Does this facility store used, recycled, or otherwise reclaimed pallets outside?
❑ Yes IN No ❑ N/A
Does this facility have coal piles on site?
❑ Yes IN No ❑ N/A
Does this facility store other fuel sources outside in piles, such as wood chips, sawdust, etc.?
❑ Yes ® No ❑ N/A
Page 4 of 6
Does this facility have air emissions associated with industrial activity (e.g., degreasing operations, ❑ Yes ❑ No 9 N/A
plating, painting, or metal finishing)?
I) yes:
Describe the industrial activity:
Are those emissions permitted by an Air Quality Permit? ❑ Yes ❑ No
Please specify:
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:
NA
❑ This facility has Non -Discharge permits (e.g. recycle permit).
If checked, list the permit numbers for all current Non -Discharge permits:
NA
❑ This facility stores hazardous waste in the 100-year floodplain.
If checked, describe how the area is protected from flooding:
NA
❑ This facility is a (mark all that apply)
91 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: Between 100 kg and 1000 kg per month
• Type(s) of waste: Waste flammable solvents and corrosive wastes primarily from laboratory testing operations
• How material is stored: Sealed drums
• Where material is stored: Indoors at lab area and dock area at Michelle
• Number of waste shipments per year: Monthly or as needed
• Name of transport/disposal vendor: Southern Logistics and Environmental, LLC (SLE)
• Transport/disposal vendor EPA ID: NCR 000 163 832
• Vendor address: 2710 Patterson Street, Greensboro, NC 27407
❑ This facility is located on a Brownfield or SUPERFUND site. NA
If checked, briefly describe the site conditions:
❑ This facility is located on Native American Lands. NA
6. Required Items (Application will be returned unless all of the following items have been included):
5d] Copy of most recent Annual Report to the NC Secretary of State (if applicable)
® This completed application and any supporting documentation
KI Copy of county map or USGS quad sheet with the location of the facility clearly marked
Page 5 of 6
7. Applicant Certification
North Carolina General Statute 143-215.68 (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:
IN I 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.
PI I have read and understand the eligibility requirements for claiming a condition of "no exposure" and obtaining an
exclusion from NPDES stormwater permitting.
® 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 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.
IN 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.
IN The information submitted in this NO] 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:
Title:
&/zoaZ
Signature of Applicant Date Signed
Mr. Brian Eckert, EHS Manager
Mail the entire package to: DEMUR —Stormwater Program
Department of Environmental Quality
1612 Mail Service Center
Raleigh, NC 27699-1612
Page 6 of 6
Exela Michelle Facility
1325 William White Place l
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C m E P Ex Ia Pharma S m,cea, LLC-MICHELLE FACILITY
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PROJECTM 49-17869 DRAWRBY: JJC FIGURE
Site Location Map
SCALE: AS SHOWN DATE: J.]2T,2022
° NORTH CAROLINA
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Department of the Secretary of State
CERTIFICATE OF AUTHORIZATION
(Long Form)
I, ELAINE F. MARSHALL, Secretary of State of the State of North Carolina, do hereby
certify that
EXELA PHARMA SCIENCES, LLC
a limited liability company organized under the laws of Delaware was authorized to transact
business in the State of North Carolina by issuance of a certificate of authority on the 30th day of
May, 2008, with its period of duration being Perpetual, under the name Exela Pharma Sciences, LLC
and the following documents have been filed since that date:
Date
Event
5/30/2008
Creation Filing
8/6/2008
Amendment
4/3/2009
Annual Report
8/14/2009
Name Change
4/15/2010
Annual Report
4/14/2011
Annual Report
3/19/2012
Annual Report
4/12/2013
Annual Report
3/28/2014
Annual Report
3/3/2015
Annual Report
1/5/2016
Annual Report
4/12/2017
Annual Report
6/19/2017
Amendment
6/27/2018
Annual Report
3/26/2019
Annual Report
4/10/2020
Annual Report
Scan to verify online.
Filed Document
Application for Certificate of Authority Limited Liability
Articles of Correction
Annual Report LLC
Corporation Name Change (Foreign)
Annual Report LLC
Annual Report LLC
Annual Report LLC
Annual Report LLC
Annual Report LLC
Annual Report LLC
Annual Report LLC
Annual Report LLC
Change of Address of Registered Office/Agent
Annual Report LLC
Annual Report LLC
Annual Report LLC
IN WITNESS WHEREOF, I have hereunto set
my hand and affixed my official seal at the City
of Raleigh, this 9th day of February, 2022.
Certification# 112073297-1 Reference# 18094285- Page: I of 2 Secretary of State
Verify this certificate online at https://www.sosne.gov/verification
Date Event
2/22/2021 Annual Report
Scan to verify online.
Filed Document
Annual Report LLC
IN WITNESS WHEREOF, I have hereunto set
my hand and affixed my official seal at the City
of Raleigh, this 9th day of February, 2022.
Certification# 112073297-1 Reference# 18094285- Page: 2 of 2 Secretary of State
Verify this certificate online at https://www.sosue.gov/verification
I, FURTHER certify that no record is found of other corporate documents having been filed since the 22nd day of February,
2021
I FURTHER certify that the said Iimited liability company's certificate of authority is not suspended for failure to comply with
the Revenue Act of the State of North Carolina; that the said limited liability company's certificate of authority is not revoked for
failure to comply with the provisions of the North Carolina Business Corporation Act; that its most recent annual report required by
G.S. 55-16-22 has been delivered to the Secretary of State; and that a certificate of withdrawal has not been issued in the name of the
said limited Iiability company as of the date of this certificate.
IN WITNESS WHEREOF, I have hereunto set
my hand and affixed my official seal at the City
of Raleigh, this 9th day of February, 2022.
AA
Scan to verify online.
Certification# 112073297-1 Reference# 18094285- Page: 3 of 2 Secretary of State
Verify this certificate online at https://www.sosne.gov/verification
Delaware Page 1
The First State
I, JEFFREY W. BULLOCK, SECRETARY OF STATE OF THE STATE OF
DELAWARE, DO HEREBY CERTIFY "EXELA PHARMA SCIENCES, LLC" IS DULY
FORMED UNDER THE LAWS OF THE STATE OF DELAWARE AND IS IN GOOD
STANDING AND HAS A LEGAL EXISTENCE SO FAR AS THE RECORDS OF THIS
OFFICE SHOW, AS OF THE NINTH DAY OF FEBRUARY, A.D. 2022.
AND I DO HEREBY FURTHER CERTIFY THAT THE SAID "EXELA PHARMA
SCIENCES, LLC" WAS FORMED ON THE THIRTIETH DAY OF MAY, A.D. 2008.
AND I DO HEREBY FURTHER CERTIFY THAT THE ANNUAL TAXES HAVE BEEN
PAID TO DATE.
4554331 8300
5R# 20220443575
You may verify this certificate online at corp.delaware.gov/authver.shtml
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Authentication:202620830
Date: 02-09-22
��, BUSINESS CORPORATION ANNUAL REPORT
ifcnon
NAME OF BUSINESS CORPORATION: EXELA PHARMSCI, INC.
SECRETARY OF STATE ID NUMBER: 1051484 STATE OF FORMATION: VA
REPORT FOR THE FISCAL YEAR END: 12/31 /2021
SECTION A: REGISTERED AGENT'S INFORMATION
1. NAME OF REGISTERED AGENT: Koneru, Phanesh
2. SIGNATURE OF THE NEW REGISTERED AGENT:
E - Filed Annual Report
1051484
CA202210114339
4/11/2022 05:15
Changes
SIGNATURE CONSTITUTES CONSENT TO THE APPOINTMENT
3. REGISTERED AGENT OFFICE STREET ADDRESS & COUNTY 4. REGISTERED AGENT OFFICE MAILING ADDRESS
1245 Blowing Rock Blvd
Lenoir, NC 28645-3618 Caldwell County
SECTION B: PRINCIPAL OFFICE INFORMATION
1245 Blowing Rock Blvd
Lenoir, NC 28645-3618
1. DESCRIPTION OF NATURE OF BUSINESS: Manufacturing Pharmaceutical
2. PRINCIPAL OFFICE PHONE NUMBER: (828) 758-5474 3. PRINCIPAL OFFICE EMAIL: Privacy Redaction
4. PRINCIPAL OFFICE STREET ADDRESS 5. PRINCIPAL OFFICE MAILING ADDRESS
1245 Blowing Rock Blvd 1245 Blowing Rock Blvd
Lenoir, NC 28645-3618 Lenoir, NC 28645-3618
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: Phanesh Koneru NAME:
TITLE: President
ADDRESS:
1245 Bowling Rock Blvd
Lenoir, NC 28645
TITLE:
ADDRESS:
NAME:
TITLE:
ADDRESS:
SECTION D: CERTIFICATION OF ANNUAL REPORT. Section D must be completed in its entirety by a person/business
entity
Phanesh Koneru 4/11/2022
SIGNATURE DATE
Form must be signed by an officer listed under Section C of this form.
Phanesh Koneru
President
Print or Type Name of Officer Print or Type TiNe 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
120221
NOTTRANSFERABLE
STATUTE US 81.106.119
North Carolina Department of Agriculture & Consumer Services
Steve Troxier, Commissioner
Food and Drug Protection Division
LICENSEICERTIFICATE: Outsourcing Facility
TYPE
Expiration Date 12/31/2022
LICENSEE EXELA PHARMA SCIENCES, LLC 1245
OR Blowing Rock Blvd, 1325 William White Place NE,
CERTIFICATOR 320 Cooperative Way, 2101 Morganton Blvd
Lenoir
NC 23645
THIS LICENSEICERTIFICATE MAY BE SUBJECT TO REVOCATION OR SUSPENSION AS PROVIDED BY LAW
120221
NOT TRANSFERABLE
STATUTE GS 81.106.119
North Carolina Department of Agriculture & Consumer Services
Steve Troxler, Commissioner
Food and Drug Protection Division
LICENSE/CERTIFICATE: Manufacturer
TYPE PRESCRIPTION DRUG LICENSE
Expiration Date 12/31/2022
LICENSEE EXELA PHARMA SCIENCES, LLC
OR 1245 Blowing Rock Blvd, 1325 William White Place NE,
CERTIFICATOR 320 Cooperative Way, 2101 Morganton Blvd
Lenoir
NC 28645
THIS LICENSEICERTS9CATE MAY BE SUBJECT TO REVOCATION OR SUSPENSION AS PROVIDED BY LAW
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STEVE TROXLER, COMMISSIONER
LICENSEtCERTIFICATE NO.
764
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STEVE TROXLER, COMMISSIONER