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HomeMy WebLinkAboutNCGNE1593_Application_20230315lVog,jEj5g3 February 24, 2022 Stormwater Permitting Unit Program North Carolina Department of Environmental Quality (DEQ) Division of Energy, Mineral and Land Resources (DEMLR) 1612 Mail Service Center Raleigh NC 27699-1612 1,.;�EcENV® MAR 151013 �RM�R-S\otmWatet PcoV�I' Re: National Pollutant Discharge Elimination System (NPDES) Application for No Exposure Certification for Tergus Pharma, 4018 Stirrup Creek Drive Durham, NC 27703 Dear Sir or Madam: Tergus Pharma is submitting the enclosed application for a No Exposure Certification for Exclusion under the NPDES stormwater permitting program. Enclosed are the following: • DEMLR NCGNE0000 form; • North Carolina Secretary of State (NCSOS) report; and • A site map developed using the Durham County Geographic Information System (GIS). Please review the enclosed application and supporting documentation and issue a Certificate for No Exposure. Thank you for your prompt attention to this matter. Please feel free to direct questions regarding the enclosed application to me at (919)370-6000. Sincerely, Tergus Pharma Aaron Rowlands Off Shift Operations Supervisor FOR AGENCY USE ONLY NCGNE (543 Assigned to: 9. COOK, ARO FRO MRO RRO WARO WIRO WSRO 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 new facilities, applicants should apply no earlier than 60 days before the start of operation. This will allow DEMUR staff to verify conditions during active operation. For facilities that already have an industrial stormwater permit 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). 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: ht�://dea 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): Tergus Pharma, LLC Douglas Haines Street address: City: State Zip Code 4018 Stirrup Creek Drive Durham NC 27703 Telephone number: Email address: 919-549-9700 DHaines@TereusPharma.com Type of Ownership: Government ❑ County ❑ Federal ❑ Municipal ❑ State Non -government O 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: Tergus Pharma Douglas Haines Street address: Telephone number: 4018 Stirrup Creek Drive 919-549-9700 Email address: DHaines@TereusPharma.com City County', State Zip Code Durham _ Durham North Carolina 27703 t Latitude of entrance: 35.917775° Longitude of entrance:-78.847379- Parcel Identification Number (PIN): --- -- — 0748-48-86-8491 - Date operation began:Standard Industrial Classification (SIC) Cade: R&D activities initiated February 2021. Commercial 8734 and 2834 _ production initiated —June 2022. "- Brief description of the types of industrial activities and products produced at this facility: R&D and batch production of topical pharmaceutical creams, ointments, semi -solids, and liquids. 3. Consultant (if applicable): Name of consultant: Consulting firm: Mark Cramer The El Group, Inc. Street address: City: State and zip code: 2101 Gateway Centre Boulevard, Suite 200 Morrisville NC 27560 Telephone number: Email address: 919-459-5229 mcrjMAL2eil.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 ❑x No ❑ N/A Materials or residuals on the ground or in stormwater inlets from spills/leaks ❑ Yes ❑x No ❑ N/A Materials or products from past industrial activity ❑ Yes ❑x 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 ❑x No ❑ N/A Materials or products stored outdoors (except final products intended for outside use [e.g., new ❑Yes ❑x 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 0 No ❑ N/A Final products that would be mobilized in stormwater discharges (e.g., rock salt) ❑ Yes ❑x No ❑ N/A Waste material (except waste in covered, non -leaking containers [e.g., dumpsters]) ❑ Yes ❑x No ❑ N/A One uncovered dumpster is present, but is only used for storing wooden pallets to be transported offsite for composting that do not have residue/staining and do not impact runoff. Application or disposal of process wastewater (unless otherwise permitted) ❑ Yes ❑x 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 ❑x No El N/A Empty containers that previously contained materials that are not properly stored (i.e., not closed ❑Yes ❑x 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 the facility had any releases in the past three (3) years? El Yes ❑ No ❑x 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 fo"r the no exposure exclusion. - Are exterior ASTs or piping free of rust, damaged or weathered coating, pits, or deterioration, or evidence of leaks? - ' ❑.yes ❑ No 0 N/A i•, Is secondary containment provided for all exterior ASTs? If so, is it free of any cracks, holes, or evidence of Leaks, and are drain valves maintained locked shut? ❑Yes ❑ No O N/A - Is secondary containment provided for single above ground storage containers (including drums, barrels, etc.) with a capacity of more than 660-gallons? p Yes'❑ No N/A Is secondary containment provided for above ground storage containers stored in close proximity to each other with a combined capacity of more than 1,320 gallons? ❑Yes ❑ No O N/A Is secondary containment provided for Title III Section 313 Superfund Amendments and Reauthorization Act (SARA) water priority chemicals? ❑Yes ❑ No O N/A Is secondary containment provided for hazardous substances designated in 40 CFR §116? ❑ Yes ❑ No O N/A Are release valves on all secondary containment structures locked? ❑ Yes ❑ No 0 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 Cl N/A Does this facility store used, recycled, or otherwise reclaimed pallets outside? IZI Yes ❑ No ❑ N/A Does this facility have coal piles on site? ❑ Yes ❑x No ❑ N/A Does this facility store other fuel sources outside in piles, such as wood chips, sawdust, etc.? ❑ Yes 0 No ❑ N/A Page 4 of 6 Does this facility have air emissions associated with industrial activity (e.g., degreasing operations, ❑x Yes ❑ No ❑ N/A plating, painting, or metal finishing)? If yes: Describe the industrial activity: Natural gas combustion from boilers, hot water heaters, and emergency generator, as well as minor VOCs from labs and batch production. Are those emissions permitted by an Air Quality Permit? ❑ Yes 19lNo Please specify: Exempt per 15A NCAC 02Q.0102(d), .0102(h)(1)(B), and 5. 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: ❑ This facility is a (mark all that apply) ❑x Hazardous Waste Generation Facility ❑ Hazardous Waste Treatment Facility ❑ Hazardous Waste Storage Facility ❑ Hazardous Waste Disposal Facility-- " - - --- — "-- - - If checked, indicate: • Kilograms of wastegenerafed each month: Small Quantity Generator (SQG) Average 777 kg/morith'in 2022. • Type(s) of waste: Primary RCRA Hazardous Waste is HPLC D001 Waste Flammable Liquids. • How material is stored: DOT steel drums and cardboard lab packs. - • Where material is stored: Hazardous waste cage inside warehouse. , • Number of waste shipments per year: 48 shipments with RCRA hazardous waste in 2022. • Name of transport/disposal vendor: Triumvirate Environmental, Inc ' • Transport/disposal vendor EPA ID:NCR000172031 • Vendor address: 1916 Garner Station Boulevard, Raleigh, NC 27603 - ❑ 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): ❑x Copy of most recent Annual Report to the NC Secretary of State (if applicable) ❑x This completed application and any supporting documentation ❑O 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 143-215.613 (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). 1 hereby request exclusion from NPDES stormwater permitting. Under penalty of law, I certify that: O 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. O 1 have read and understand the eligibility requirements for claiming a condition of "no exposure' and obtainingan exclusion from NPDES stormwater permitting. OThere 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)). 0 1 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. IXI 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. ❑x The information submitted in this N01 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: Douglas Haines Title: Senior Manager, Engineering, Facilities, Maintenance, and Safety 23Ff6Zo2t Signp re Qppl nt Date Signed Mail the entire package to: DEMLR —Stormwater Program Department of Environmental Quality 1612 Mail Service Center Raleigh, NC 27699-1612 Page 6 of 6 UJ f tg LIMITED LIABILITY COMPANY ANNUAL REPORT r= dfA, N._:� IIWW22 NAME OF LIMITED LIABILITY COMPANY: TerguS Pharma, LLC SECRETARY OF STATE ID NUMBER: 1251654 STATE OF FORMATION: NC REPORT FOR THE CALENDAR YEAR: 2022 AMENDING DOC ID SECTION A: REGISTERED AGENT'S INFORMATION 1. NAME OF REGISTERED AGENT: TerguS Pharma, LLC 2. SIGNATURE OF THE NEW REGISTERED AGENT: E - Filed Annual Report 1251654 CA202206906942 3/10/2022 03:15 Changes SIGNATURE CONSTITUTES CONSENT TO THE APPOINTMENT 3. REGISTERED AGENT OFFICE STREET ADDRESS & COUNTY 4. REGISTERED AGENT OFFICE MAILING ADDRESS 4018 Stirrup Creek Dr 4018 Stirrup Creek Dr Durham, NC 27703 Durham County Durham, NC 27703 SECTION B: PRINCIPAL OFFICE INFORMATION 1. DESCRIPTION OF NATURE OF BUSINESS: Pharmaceutical 2. PRINCIPAL OFFICE PHONE NUMBER: (919) 491-3252 3. PRINCIPAL OFFICE EMAIL: Privacy Redaction 4. PRINCIPAL OFFICE STREET ADDRESS 5. PRINCIPAL OFFICE MAILING ADDRESS 4018 Stirrup Creek Dr 4018 Stirrup Creek Dr Durham, NC 27703 Durham, NC 27703 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: COMPANY OFFICIALS (Enter additional company officials in Section E.) NAME: Vijendra Nalamothu NAME: TITLE: Chief Executive Offer TITLE: ADDRESS: 4018 Stirrup Creek Dr Durham, NC 27703 ADDRESS: NAME: TITLE: ADDRESS: SECTION D: CERTIFICATION OF ANNUAL REPORT. Section D must be completed in its entirety by a person/business entity. Vijendra Nalamothu 3/10/2022 SIGNATURE DATE Fomr must be signed by a Company Official listed under Section C of This form. Vijendra Nalamothu Chief Executive Officer Print or Type Name of Company Official Print or Type Title of Company Official This Annual Report has been filed electronically. MAIL TO: Secretary of State, Business Registration Division, Post Office Box 29525, Raleigh, NC 27626-0525 s e ` w � a 1 r . t r: t 3 Pond Site Stirrup Iron Creek r, F