Consent of copyright owner required for any other use. Attachment E. For inspection purposes only. Emissions. EPA Export :15:19:52

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1 Attachment E Emissions i

2 TABLE OF CONTENTS 1 EMISSIONS TO ATMOSPHERE Boiler Emissions Main Emissions Minor Emissions Fugitive & Potential Emissions EMISSIONS TO SEWER Process Emissions Process Effluent Treatment Assessment of Impact of Emissions to Sewer/Waters Sanitary Emissions EMISSIONS TO SURFACE WATERS EMISSIONS TO GROUND WASTEWATER NETWORK INSPECTION Drawing E.1 Main Emission Points to Atmosphere Drawing E.2 Minor Emission Points to Atmosphere Drawing E.3 Potential & Fugitive Emission Points Drawing E.4 Sewer & Stormwater Emission and Monitoring Points ii

3 1 Emissions to Atmosphere The following types of emissions to atmosphere are present at the AbbVie facility: Main Minor Potential & Fugitive 1.1 Boiler Emissions There are currently 4 boilers in operation at the AbbVie facility; 3 gas boilers and a Low Pressure Hot Water (LPHW) woodchip boiler. The natural gas fuelled boilers at the Carrigtwohill facility are below 5MW and hence are classified as minor emissions. The woodchip boiler has a duty of 200kW which is below the 250 kw threshold and hence has also been classified as a minor emission. An additional boiler is being installed for the Creon project. 1.2 Main Emissions Main emissions include all emissions of environmental significance. To determine environmental significance, reference is made to the emission limit value (ELV)/mass emission threshold used in the applicable BAT Guidance Notes for this facility. Regardless of the above the EPA has confirmed that all emissions from equipment that may contain particulate API should be considered main emissions. A summary list of main emission points to atmosphere is provided in Table 1 below, this includes the list of both existing and proposed main emission points. 1

4 Emission Reference Point Description A2-1 Thermal Oxidiser Stack A2-2 R370 Dust Collector Exhaust air A2-3 Process Dust Collector Air Exhaust (M-13-1-DC-001) A2-4 Fluid Bed Dryer Exhaust A2-5 Dust collector exhaust (250mm diam) A2-6 Scale Up Fluid Bed Dryer Exhaust A2-7 Fluid Bed Dryer Exhaust (500mm diam) A2-8 Glatt Vessel Vent A2-9 Glatt Fluid Bed Dryer Exhaust (400mm diam) A2-10 Glatt Fluid Bed Dryer Exhaust (250mm diam) A2-11 Tablet Coater 1 Process Air Exhaust (M-14-1) A2-12 Tablet Coater 2 Process Air Exhaust (M-14-2) A2-13 Coater Exhaust (M-14-3) A2-14 Future Emission Point 1 (Process Equipment) A2-15 Dust Collector Vent to atm. (4 presses) A2-16 Future Emission Point 2 (Process Equipment) A2-17 Future Emission Point 3 (Process Equipment) A2-18 Future Emission Point 4 (Process Equipment) A2-19 Future Emission Dust Collector Vent to atm. A2-20 Future Emission Point 5 (Process Equipment) Table 1: Summary of Main Emission Points to Atmosphere Details on these emissions can be found in Tables E.1(ii) and E.1(iii) of the main application. A location drawing is provided in this attachment. Impacts are addressed in Section I of the application. 2

5 1.3 Minor Emissions Emissions not regarded as environmentally significant and having a discharge associated with them during normal operation are regarded as minor emission points. There are 62 minor emissions from the facility as detailed in Table 2 below. Emission Reference Number Description A3-1 M-172-FN-002 Exhaust (300mm diam.) A3-2 Process Drain (Train B Production) Vent (100mm diam) - East A3-3 Process Vacuum pump exhaust A3-4 Condensate Receiver Vent (50mm diam.) A3-5 IBC Wash Vent Point (250mm diam.) A3-6 Process Drain (Train B Production) Vent (150mm diam) - West A3-7 Purified Water Storage Tank Vent (40mm) A3-8 Purified Water Ozone Generator Vent (6mm diam.) A3-9 Nitrogen PSA Skid Vent (100mm diam.) A3-10 Condensate Receiver Vent (80mm diam.) A3-11 Clean Steam Generator Vent #1 (25mm diam.) A3-12 Clean Steam Generator Vent #2 (40mm diam.) A3-13 Clean Steam Generator Vent #3 (25mm diam.) A3-14 Steam Pressure Reducing Skid Vent #1 (100mm diam) A3-15 Steam Pressure Reducing Skid Vent #2 (100mm diam) A3-16 Vacuum pump vent (40mm diam) A3-17 Vacuum pump vent (50mm diam) A3-18 Process Drain (Scale up facility) Vent (100mm diam) - West A3-19 Process Drain (Scale up facility) Vent (100mm diam) - East A3-20 Scale-Up Facility Shower Area Exhaust A3-21 Scale-Up Facility Steam Header Vent (60mm diam) A3-22 Scale-Up Facility Condensate Receiver Vent (50mm diam.) A3-23 Steam Boiler Flue A3-24 Boiler Blow-Down Tank Vent (200mm diam) A3-25 Steam Boiler (Robey Loos) Flue 3

6 Emission Reference Number Description A3-26 Condensate Storage Tank Vent A3-27 LPHW Boiler Flue Vent A3-28 QC Lab Room 106 Solvent Cabinet Extract A3-29 Lab Fume Hood Exhaust A3-30 Lab Fume Hood (Extract Fan EF-401) Exhaust A3-31 Extract from Filter Sock Dryer (M-182-DR-001) A3-32 PW Storage tank vent (40mm diam) A3-33 Ozone generator vent (8mm diam) A3-34 Vacuum pump exhaust (50mm diam) A3-35 Room R302 Utility Panel Vent (25mm diam.) A3-36 Process Drain Vent (100mm diam) A3-37 Lab Fume Hood (Extract Fan EF-501) Exhaust A3-38 Lab Fume Hood (Extract Fan EF-601) Exhaust A3-39 Lab Fume Hood (Extract Fan EF-701) Exhaust A3-40 QC Lab 2 (Room 106) Fumehood 005 Exhaust A3-41 Process drain vent (100mm diam.) A3-42 Deduster (M-13-3) Vent A3-43 Scale-Up Facility Bed Dryer Dessicant Wheel Exhaust A3-44 Scale-Up Facility Coater Process Air Exhaust A3-45 BMS1-DPS-0504 Vent A3-46 AHU 1 Exhaust Point A3-47 AHU 2 Exhaust Point A3-48 AHU 3 Exhaust Point A3-49 IR AHU 1 Exhaust Point A3-50 IR AHU 1 Exhaust Point A3-51 Encapsulator 1 PTS Skid outlet A3-52 Encapsulator 2 PTS Skid outlet A3-53 PEG Melt vent to atm. A3-54 Coating Solution Preparation Vessel A3-55 Coating Solution Preparation Vessel A3-56 Coater CIP Skid 4

7 Emission Reference Number Description A3-57 IBC Washer A3-58 Main CIP Skid A3-59 Proposed LPHW Boiler A3-60 TBC A3-61 TBC Table 2: Minor Emissions Location drawings are provided in this attachment. Impacts are addressed in Section I of the application. A detailed list of minor emission points to atmosphere is provided in Table E.1 (iv): Minor Atmospheric Emissions. 5

8 1.4 Fugitive & Potential Emissions Potential emission points are those that under Normal Operation do not emit any discharge but may do so in Abnormal Operation, e.g.; pressure release valves. Fugitive emissions are emissions of gases or vapours from pressurised equipment due to leaks and other unintended or irregular releases of gases. Fugitive emissions are also associated with the use of highly volatile substances which are inclined to vaporise in ambient atmospheric conditions, such as the use of volatile organic compounds (VOCs). A summary list of emissions to atmosphere is provided in Table E.1 (v): Fugitive and Potential Atmospheric Emissions. Location drawings are provided in this attachment. The facility has been designed to minimise potential sources of fugitive emissions arising from process areas and buildings. Fugitive emission sources may be limited to minor leakages from connections, isolation and control valves, relief valves, equipment seals and analysers. Fugitive solvent emissions are minimal due to; the closed loop coating and drying systems and dedicated solvent recovery and abatement systems on-site. Good housekeeping practices, including preventative maintenance and routine monitoring of equipment on-site minimise the potential for any equipment leaks. Conservation vents are fitted on all tanks in the bulk storage tank farm to minimise any fugitive emissions during storage of materials. Standard operating procedures will be implemented to minimise any fugitive emissions during road tanker loading/unloading. Additionally, the use of >50 tonnes of organic solvent per annum will require AbbVie to comply with the fugitive emission limit values specified for the activity in European Union (Installations and Activities using Organic Solvents) Regulations 2012, (S.I. No. 565 of 2012). 6

9 2 Emissions to Sewer 2.1 Process Emissions Process wastewater arises from the production areas (process wastewaters generated at the facility are those originating from wash-down activities, namely wet washing of blending bins/pans, washing of utensils/small items, washing of pallets) on-site, laboratory activities and from boiler blowdown. AbbVie currently generates, on average, 130m 3 of process effluent per day. The amount of effluent will vary from day to day depending on various factors including the type of product manufactured, production schedule and availability of purified water for both cleaning and production use. Process effluent arises primarily from: Automatic washings of process vessels (referred to as CIP washes) mostly blending and granulation vessels, and coating and drying equipment; Manual washings of equipment, such as IBCs and small equipment parts between production runs; Hand washes and showers taken by staff working in production. Cooling tower make up water; Boiler blowdown; Laboratory sinks; Surplus purified water; Reverse osmosis plant discharge. The majority of process effluent generated on-site arises from the water purification process. The generation of purified water from potable water creates a waste water that is sent to the effluent treatment system. Approximately one third of the potable water used by the Reverse Osmosis (RO) plant is generated into purified water; two thirds is waste water. Therefore, one-third of purified water is used during production and cleaning activities while the remaining two-thirds is waste water from the purified water generation process. Process effluent generated by CIP washes and manual washings of equipment may potentially contain residual amounts of raw materials and traces of Active Pharmaceutical Ingredients (APIs). Production is not continuous, i.e. products are manufactured in batches, and therefore the volume and quality of effluent varies over time. 7

10 The sinks in the laboratories are for the washing of laboratory glassware only. There are no solvents or chemicals discharged to drain from this source. The scale-up facility is used for production of small quantities of the new products for new process validation and testing. Process effluent undergoes preliminary treatment on-site, consisting of ph and temperature correction, prior to discharge via sewer to the Carrigtwohill WWTP. There is one process emission point to sewer (SE-1) at the AbbVie site which is summarised in Table 3. The new processes will connect to the existing process drainage system and therefore not result in an additional emission point to sewer. Ref No. Location Source SE-1 Existing 305 mm diameter pipe discharging to existing foul water sewer line outside site boundary to the south. Table 3: Emissions to Sewer 2.2 Process Effluent Treatment Process Wastewater Process effluent from all production areas and the warehouse is routed to the main process effluent sump located on the grass verge in front of the production building s main door. There is one smaller collection sump which feeds into the main sump located upstream of the main sump. From the main process effluent sump, the effluent then goes to a 20m 3 collection chamber located adjacent to it in the car park. From here, the process effluent is routed to the ph Correction Plant. From the ph Correction Plant, process effluent is discharged to the Irish Water foul sewer which runs beneath the road in front of the site. AbbVie currently monitors treated process effluent prior to discharge to the Irish Water foul sewer system. A summary of the current Discharge to Sewer monitoring parameters, associated monitoring frequency and emission limits is presented in Table 4. Results of sampling conducted in 2015 has been included in Table 4 as an example of typical post-treatment process effluent characteristics. It is proposed to carry the ELVs of the Discharge to Sewer Licence over to the Industrial Emissions Licence as part of this application. 8

11 Parameter Limits Test Frequency 2015 Results Flow 300 m 3 /day or 50m 3 /hr Continuously Compliant ph Continuously 7.1 Temperature (max.) 34 o C Continuously Compliant B.O.D. Biological Oxygen Demand C.O.D Chemical Oxygen Demand 300 mg/l Weekly 20 mg/l 1,500 mg/l Weekly 168 mg/l Total Suspended Solids 750 mg/l Weekly 40 mg/l Total Phosphorus 4 mg/l Annually 0.32 mg/l Total Nitrogen 50 mg/l Annually 3.2 mg/l Sulphates 100 mg/l Annually 31 mg/l Hydrocarbons 1 mg/l Annually 0.02 mg/l Detergents (anionic, cationic and nonionic) 5 mg/l Annually 0.01 mg/l Table 4: Discharge to Sewer Licence Emission Limit Values The proposed Creon DR process will have effluent discharges from the cleaning of equipment. All CIP solutions and rinses will be sent to drain for treatment. Details on process emissions can be found in Tables E.3(i) and E.3(ii) of the main application. A location drawing is provided in this attachment. Impacts are addressed in Section I of the application. 9

12 2.2.1 Assessment of Impact of Emissions to Sewer/Waters At all stages of the development of the AbbVie site, assessments were carried out on the effluents (independent toxicity, respirometry and biodegradation trials) to ensure that the effluents were: Biodegradable; Non-Toxic; Non-Inhibitory. Respirometry testing previously conducted on process effluent from the AbbVie facility indicated that the process effluent is not adversely affecting the operation of the Carrigtwohill WWTP. The results indicated that the AbbVie sample tested exhibited no acute toxicity/inhibition to a mixed microbial population, including nitrifying organisms in the activated sludge, from the lower aeration basin of Carrigtwohill WWTP A copy of the respirometry test report is included in Attachment I Sanitary Emissions Sanitary wastewater from the AbbVie site is discharged into the IDA Park foul network at two separate locations. Foul effluent consists of the canteen and sanitary effluent from the toilets and canteen which is routed into the Irish Water foul sewer, which ultimately discharges to the Carrigtwohill WWTP. 10

13 3 Emissions to Surface Waters The foul/process wastewater system and surface water system are segregated to minimise the unnecessary treatment of uncontaminated water. Stormwater drainage at the site is collected separately from the process drains and foul drains. The stormwater drainage is a conventional gravity system. The stormwater drainage network serves the carpark, the roofs of the buildings and other outdoor areas of the site. The existing drainage system operates as follow: 1) Roof areas are drained via appropriate falls provided to roof surfaces that allow the surface water run-off discharge to downpipes and into the dedicated existing surface water network. 2) Hardstanding areas such as roads, paths and other hard standing areas are drained by means of a series of gullies & drains that discharge the surface water run-off into a dedicated existing surface water network. There are four petrol interceptors on the stormwater network through which stormwater drains prior to discharge into the Cork County Council storm sewer. The Cork County Council stormwater sewer also serves other facilities in the IDA Business Park within which the AbbVie facility is located. The combined surface water is discharged from the Council stormwater sewer to the receiving waters in the Great Island Channel. Surface water bodies are considered the sensitive receptor in the event of unconfined or uncontrolled loss of contaminated water mixtures from AbbVie. The surface water sewer system discharges ultimately to Slatty Bridge, at a point located approximately 0.8 km south of the site. This is part of Great Island Channel, which is a Special Area of Conservation and a Proposed National Heritage Area. Great Island Channel is connected with Cork Harbour which is a Special Protected Area. The new development will be connected to the existing system and will not result in any additional emission points for storm waters. Storm water discharge points (SW-1 and SW-2) are indicated on the Site Location Map which is provided in the Appendix. 11

14 Ref No. Location Source SW-1 South-eastern Corner of Site (Adjacent to main site entrance) Storm Water Runoff SW-2 Southern boundary of the site Storm Water Runoff Table 5: Emissions to Surface Water The quantities of surface water arising on-site depend on rainfall. Details on this emission can be found in Tables E2(i) and E2(ii). A location drawing is provided in this attachment. Impacts are addressed in Section I of the application. 4 Emissions to Ground There are no emissions to ground from the AbbVie site. Results of groundwater monitoring indicate groundwater is not being impacted by the activities on-site. AbbVie has completed a Baseline Report on soil and groundwater conditions at the facility in compliance with the requirements of the Industrial Emissions Directive. This report can be found in Attachment I.4 of the application. 5 Wastewater Network Inspection Major cleaning of the wastewater drainage network (and CCTV testing) takes place every 3 years, and the last major cleaning event was carried out in the first two weeks of July 2016 during the plant annual shutdown period. Emptying petrol interceptors, underground tanks and the grease trap occurs annually. 12

15 Drawing E.1 Main Emission Points

16 MAIN EMISSIONS TO ATMOSPHERE NOTES: 1. ALL LEVELS RELATE TO ORDNANCE SURVEY DATUM, MALIN HEAD 2. CO-ORDINATES TO IRISH GRID PROJECTION CREON OPTIMISED CONSULTING ENGINEERS 2a RIVER HOUSE, BLACKPOOL PARK, BLACKPOOL, CORK. TEL WEB FOURNIER LABORATORIES IRELAND LTD., IDA Industrial Estate, Carrigtohill, County Cork, Ireland. MAIN EMISSIONS TO ATMOSPHERE (SHEET 1 of 2) L-04 A

17 CREON OPTIMISED CONSULTING ENGINEERS 2a RIVER HOUSE, BLACKPOOL PARK, BLACKPOOL, CORK. TEL WEB FOURNIER LABORATORIES IRELAND LTD., IDA Industrial Estate, Carrigtohill, County Cork, Ireland. MAIN EMISSION TO ATMOSPHERE (SHEET 2 of2) L-04a A

18 Drawing E.2 Minor Emission Points

19 MINOR EMISSIONS TO ATMOSPHERE NOTES: 1. ALL LEVELS RELATE TO ORDNANCE SURVEY DATUM, MALIN HEAD 2. CO-ORDINATES TO IRISH GRID PROJECTION CREON OPTIMISED CONSULTING ENGINEERS 2a RIVER HOUSE, BLACKPOOL PARK, BLACKPOOL, CORK. TEL WEB FOURNIER LABORATORIES IRELAND LTD., IDA Industrial Estate, Carrigtohill, County Cork, Ireland. MINOR EMISSIONS TO ATMOSPHERE (SHEET 1 of 2) L-05 A

20 CREON OPTIMISED CONSULTING ENGINEERS 2a RIVER HOUSE, BLACKPOOL PARK, BLACKPOOL, CORK. TEL WEB FOURNIER LABORATORIES IRELAND LTD., IDA Industrial Estate, Carrigtohill, County Cork, Ireland. MINOR EMISSIONS TO ATHMOSPHERE (SHEET 2 of 2) L-05a A

21 Drawing E.3 Potential & Fugitive Emission Points

22 NOTES: 1. ALL LEVELS RELATE TO ORDNANCE SURVEY DATUM, MALIN HEAD 2. CO-ORDINATES TO IRISH GRID PROJECTION POTENTIAL & FUGITIVE EMISSIONS TO ATMOSPHERE CREON OPTIMISED CONSULTING ENGINEERS 2a RIVER HOUSE, BLACKPOOL PARK, BLACKPOOL, CORK. TEL WEB FOURNIER LABORATORIES IRELAND LTD., IDA Industrial Estate, Carrigtohill, County Cork, Ireland. POTENTIAL & FUGITIVE EMISSIONS TO ATMOSPHERE (SHEET 1 of 2) L-06 A

23 Drawing E.4 Sewer & Stormwater Emission and Monitoring Points

24 EMISSION & MONITORING POINT LOCATIONS NOTES: 1. ALL LEVELS RELATE TO ORDNANCE SURVEY DATUM, MALIN HEAD 2. CO-ORDINATES TO IRISH GRID PROJECTION CREON OPTIMISED CONSULTING ENGINEERS 2a RIVER HOUSE, BLACKPOOL PARK, BLACKPOOL, CORK. TEL WEB FOURNIER LABORATORIES IRELAND LTD., IDA Industrial Estate, Carrigtohill, County Cork, Ireland. SURFACE WATER & SEWER EMISSIONS & MONITORING POINTS L-09 A

25 CREON OPTIMISED CONSULTING ENGINEERS 2a RIVER HOUSE, BLACKPOOL PARK, BLACKPOOL, CORK. TEL WEB FOURNIER LABORATORIES IRELAND LTD., IDA Industrial Estate, Carrigtohill, County Cork, Ireland. POTENTIAL & FUGITIVE EMISSIONS TO ATMOSPHERE (SHEET 2 of 2 ) L-06a A

26 Attachment E.6 Tabular Data on Emissions Points

27 TABLE OF CONTENTS 1 SUMMARY TABULAR DATA ON EMISSION POINTS... 1

28 1 Summary Tabular Data on Emission Points Point Code Point Type Easting Northing Verified Emission A2-1 A Y NO x, SO x, CO, TOC, VOC, Dioxins/Furan A2-2 A Y Particulates A2-3 A Y Particulates A2-4 A Y Particulates A2-5 A Y Particulates A2-6 A Y Particulates, VOC A2-7 A Y Particulates A2-8 A Y Particulates A2-9 A Y Particulates A2-10 A Y Particulates A2-11 A Y Particulates A2-12 A Y Particulates A2-13 A Y Particulates A2-14 A Y Particulates A2-15 A Y Particulates A2-16 A Y Particulates A2-17 A Y Particulates A2-18 A Y Particulates A2-19 A Y Particulates A2-20 A Y Particulates A3-1 A N Water vapour A3-2 A N Water vapour A3-3 A N Water vapour A3-4 A N Water vapour A3-5 A N Water vapour A3-6 A N Water vapour A3-7 A N Water vapour A3-8 A N Ozone A3-9 A N Nitrogen A3-10 A N Water vapour A3-11 A N Water vapour A3-12 A N Water vapour A3-13 A N Water vapour A3-14 A N Water vapour A3-15 A N Water vapour 1

29 Point Code Point Type Easting Northing Verified Emission A3-16 A N Water vapour A3-17 A N Water vapour A3-18 A N Water vapour A3-19 A N Water vapour A3-20 A N Water vapour A3-21 A N Water vapour A3-22 A N Water vapour A3-23 A N NO X, CO 2 A3-24 A N Water vapour A3-25 A N Water vapour A3-26 A N Water vapour A3-27 A N NO X, CO A3-28 A N Solvent vapour A3-29 A N Solvent vapour A3-30 A N Solvent vapour A3-31 A N Water vapour A3-32 A N Water vapour A3-33 A N Ozone A3-34 A N Water vapour A3-35 A N Water vapour A3-36 A N Water vapour A3-37 A N Solvent vapour A3-38 A N Solvent vapour A3-39 A N Solvent vapour A3-40 A N Solvent vapour A3-41 A N Water vapour A3-42 A N Particulates A3-43 A N Particulates A3-44 A N Water Vapour, Particulates A3-45 A N TBC A3-46 A N TBC A3-47 A N TBC A3-48 A N TBC A3-49 A N TBC A3-50 A N Particulate A3-51 A N Particulate A3-52 A N Particulate A3-53 A N N 2/PEG 2

30 Point Code Point Type Easting Northing Verified Emission A3-54 A N Acetone /PMP /Tri-ethyl citrate/dimethicone/cetyl Alcohol A3-55 A N Acetone /PMP /Tri-ethyl citrate/dimethicone/cetyl Alcohol A3-56 A N Water Vapour A3-57 A N Water Vapour A3-58 A N Water Vapour A3-59 A N Proposed LPHW Boiler A3-60 A N TBC A3-61 A N TBC A4-1 A N Particulates A4-2 A N Steam A4-3 A N Steam A4-4 A N Steam A4-5 A N Smoke, particulates A4-6 A N Steam A4-7 A N Steam A4-8 A N Steam A4-9 A N Steam A4-10 A N Steam A4-11 A N Particulates A4-12 A N Steam A4-13 A N Steam A4-14 A N Steam A4-15 A N Steam A4-16 A N Acetone, HPMP, Tri-ethyl citrate, Dimethicone, Cetyl Alcohol A4-17 A N Acetone, HPMP, Tri-ethyl citrate, Dimethicone, Cetyl Alcohol A4-18 A N Acetone, Particulates, Polyethylene A4-19 A N Acetone Glycol, HPMP, Tri-ethyl citrate, Dimethicone, Cetyl Alcohol A4-20 A N Dilute CIP solution (Oxonia) A4-21 A N Dilute CIP solution (Oxonia) A4-22 A N Polyethylene Glycol A4-23 A N Particulates /PEG A5-1 A N Diesel vapour A5-2 A N Diesel vapour 3

31 Point Code Point Type Easting Northing Verified Emission A5-3 A N Acetone vapour SE-1 SE N Treated process waste water SW-1 SW N Uncontaminated stormwater SW-2 SW N Uncontaminated stormwater 4