Screening Statement. Pfizer Ireland Pharmaceuticals. Document Stage Document Version Prepared by Final 2 Pat Doherty MSc, MCIEEM. For and on behalf of

Transcription

1 Screening Statement in Support of Appropriate Assessment Pfizer Ireland Pharmaceuticals, Newbridge, Co. Kildare Doherty Environmental September 2018 EPA Export :03:35:14

2 Screening Statement Pfizer Ireland Pharmaceuticals Document Stage Document Version Prepared by Final 2 Pat Doherty MSc, MCIEEM For and on behalf of Doherty Environmental Prepared By: Pat Doherty Signed: This report has been prepared by Doherty Environmental with all reasonable skill, care and diligence. Information report herein is based on the interpretation of data collected and has been accepted in good faith as being accurate and valid. This report is prepared for Environet Solutions and we accept no responsibility to third parties to whom this report, or any part thereof, is made known. Any such party relies on the report at their own risk. Doherty Environmental i 12/09/2018 EPA Export :03:35:14

3 Table of Contents 1.0 INTRODUCTION STAGE 1 SCREENING METHOD PROJECT SITE DESCRIPTION PROJECT DESCRIPTION GASEOUS EMISSIONS NOISE EMISSIONS DRAINAGE SOLID WASTE PROCESS EFFLUENT ABATEMENT STORM WATER DRAINAGE & CONTAINMENT CONTAINMENT OF SPILLS & LEAKS CONTAINMENT IN THE EVENT OF A FIRE EMISSIONS TO ATMOSPHERE ABATEMENT THE PROJECT & EUROPEAN SITE BASELINE IDENTIFICATION OF EUROPEAN SITES SCREENING STATEMENT CONCLUSION: FINDING OF NO SIGNIFICANT EFFECTS 29 REFERENCES 30 Doherty Environmental ii 12/09/2018 EPA Export :03:35:14

4 1.0 INTRODUCTION Doherty Environmental was commissioned by Environet Solution to undertake a Stage 1 Habitats Directive Assessment Screening for Appropriate Assessment for activities relating to the provision of a new (retrofitted) manufacturing suites dedicated to the manufacture of Eliquis and other similar drugs in the existing manufacturing Buildings 3A and 4-2, located within the existing Pfizer Ireland Pharmaceuticals Newbridge facility. This Screening for Appropriate Assessment forms Stage 1 of the Habitats Directive Assessment process and is being undertaken in order to comply with the requirements of the Habitats Directive Article 6(3). The function of this Screening Exercise is to identify the potential for the project to result in likely significant effects to European Sites and to provide information so that the competent authority can determine whether a Stage 2 Appropriate Assessment is required for the project. 1.1 STAGE 1 SCREENING METHOD The function of the Screening exercise is to identify whether or not the proposal will have the potential to result in likely significant effect on European Sites. In this context likely refers to the presence of doubt with regard to the absence of significant effects (ECJ case C-127/02) and significant means not trivial or inconsequential but an effect that has the potential to undermine the site s conservation objectives (English Nature, 1999; ECJ case C-127/02 &). In other words, any effect that compromises the conservation status of a European Sites and interferes with achieving its conservation objectives would constitute a significant effect. The nature of the likely interactions between the project and the conservation status of European Sites will depend upon the sensitivity of these sites and their reasons for designation to potential impacts arising from the project; the current conservation status of the features for which European Sites have been designated; and any likely changes to key environmental indicators (e.g. habitat structure; vegetation community) that underpin the conservation status of European Sites, in combination with other plans and projects. This Screening exercise has been undertaken with reference to respective National and European guidance documents: Appropriate Assessment of Plans and Projects in Ireland: Guidance for Planning Authorities (DEHLG 2010) and Assessment of Plans and Projects Doherty Environmental 1 12/09/2018 EPA Export :03:35:14

5 Significantly Affecting Natura 2000 sites Methodological Guidance of the Provisions of Article 6(3) and (4) of the Habitats directive 92/43/EEC and recent European and National case law (ECJ C-258/11 & High Court case ref JR). The following guidance documents were also of relevance during this Screening Assessment: A guide for competent authorities. Environment and Heritage Service, Sept Appropriate Assessment of Plans and Projects in Ireland Guidance for Planning Authorities (2010). DEHLG. Assessment of Plans and Projects Significantly Affecting Natura 2000 Sites Methodological Guidance of the Provisions of Article 6(3) and (4) of the Habitats Directive 92/42/EED. European Commission (2001). Managing Natura 2000 Sites The provisions of Article 6 of the Habitats directive 92/43/EEC. European commission (2000). (To be referred to as MN 2000). The EC (2001) guidelines outline the stages involved in undertaking a Screening exercise of a project that has the potential to have likely significant effects on European Sites. The methodology adopted for this Screening exercise is informed by these guidelines and was undertaken in the following stages: 1. Describe the project and determine whether it is necessary for the conservation management of European Sites; 2. Identify European Sites that could be influenced by the project; 3. Where European Sites are identified as occurring within the sphere of influence of the project identify potential effects arising from the project and screen the potential for such effects to negatively affect European Sites identified under Point 2 above; and 4. Identify other plans or projects that, in combination with the project, have the potential to affect European Sites. 2.0 PROJECT SITE DESCRIPTION The Pfizer site is located within the town-land of Little Connell, north east of Newbridge town centre and adjacent to the R445 as shown on Figure 2.1. The current Pfizer landholding Doherty Environmental 2 12/09/2018 EPA Export :03:35:14

6 consists of approximately 48.6 hectares. The facility is currently accessed from the R445 dual carriageway via a roundabout and single access road. The Fossit Level 3 habitats occurring within the site are amenity grassland GA2; dry meadow and grassy verge GS2; HedgerowsWL1/Treelines WL2; immature woodland WS2; and Buildings and artificial surfaces BL3. The buildings and artificial surface habitat on site consists of the footprint of the site buildings and parking areas. Landscaped hedgerows and treelines border the site. No watercourses or drainage ditches occur within or in the surrounding vicinity of the project site. Surrounding land use in the vicinity of the plant is a combination of agricultural, commercial and residential with neighbouring land use as follows: North: Stud Farm South: Supermarket Distribution Company West: Residential Area East: Agricultural Land The majority of the site is utilised by Pfizer for the overall production operation, access roads and car parking requirements. Approximately 60% of the site is utilised for production facilities, wastewater treatment plant and waste storage areas. The remainder is used for internal access road, car parking and open green space. Doherty Environmental 3 12/09/2018 EPA Export :03:35:14

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8 3.0 PROJECT DESCRIPTION This project involves the retrofit of an existing manufacturing suites, which will be dedicated to the drug product manufacturing processes for the preparation of Eliquis and similar drug products within the existing Pfizer facility at Newbridge, Co. Kildare. For Eliquis it is proposed to retrofit an existing processing area in Building 4-2 (see Plate 3.1 for building location) to accommodate the associated manufacturing process. For other similar drugs it is proposed that an Extended Technology Innovation Centre is provided for within the existing production rooms of Building 3A. Here it is proposed to extend existing site pilot plant facilities for supporting future product technical developments for similar drug product manufacturing processes. In order to achieve this it is proposed to retrofit the existing production rooms in Building 3A. Plate 3.1: Location of manufacturing suite within the Pfizer Ireland facility Doherty Environmental 5 12/09/2018 EPA Export :03:35:14

9 3.1 GASEOUS EMISSIONS The project will involve the virtual relocation and modification of selected licenced main emissions to atmosphere that were not previously installed on-site or are off-line. These points are as follows: Eliquis: Building 4 - Emission Point Reference No. A2-60, A2-61, A2-62, A2-67, A2-89, A2-90, A2-91, A2-92, A2-93, A2-94). Extended Technology Innovation Centre: Building 4 - Emission Point Reference No. A2-14, A2-49c. The proposed modifications are as follows: Change the location (building) of emissions points (i.e. A2-49c, A2-60, A2-61, A2-62, A2-67, A2-89, A2-90, A2-91, A2-92, A2-93, A2-94) and modify the vent dimensions (diameter, height above ground) of emissions points A2-49c - height above ground only, A2-60, A2-61, A2-62, A2-67, A2-89, A2-90, A2-91, A2-92, A2-93, A2-94; Modify the source (change in production process that the emission points serve) and reclassify the chemical characteristics (change from hormonal to non-hormonal emissions) for emission points A2-60, A2-61, A2-62, A2-67, A2-89, A2-90, A2-91, A2-92, A2-93, A2-94; Doherty Environmental 6 12/09/2018

10 Decrease the permitted hourly flowrate (with an overall net decrease in daily flowrate) for emission points A2-60, A2-61, A2-62, A2-67, A2-89, A2-90, A2-91, A2-92, A2-93, A2-94; Extend the period of emission (to 24 hours/day for emission point A2-24 and to 365 days/year for emission points A2-14, A2-49c, A2-60, A2-61, A2-62, A2-67, A2-89, A2-90, A2-91, A2-92, A2-93, A2-94. All gaseous emissions arising from the facility will be directed to the HVAC system. The HVAC systems and non-process utility systems shall comprise of the following installations: New Supply and Extract Air Handling Systems to serve the Production and associated Technical areas House Vacuum System Local Exhaust Ventilation (LEV) System Low Pressure Hot Water (LPHW) System Medium Temperature Hot Water (MTHW) System Chilled Water (CHW) System Emergency and Mist Showers Building Management System (BMS) Qualified Building Management System (QBMS). All engineering, design, materials of construction, fabrication, inspection, testing/ commissioning and certification shall conform to the current applicable EU and Irish Standards, Codes & Statutory Requirements. 3.2 NOISE EMISSIONS Noise requirements on site shall be as follows: site perimeter 55 db (daytime) and 45 db (night time). Equipment not meeting these criteria shall be provided with acoustic attenuation as necessary. Doherty Environmental 7 12/09/2018

11 3.3 DRAINAGE There are existing process drains under the first floor slab and ground slabrunning under the footprint of building 3A (Extended Technology Innovation Centre) and 4-2 (Eliquis) respectively. 3.4 SOLID WASTE The handling of solid waste will be as per site procedures. 3.5 PROCESS EFFLUENT ABATEMENT The Pfizer Ireland facility at Newbridge has an onsite enclosed state of the art wastewater pretreatment plant (WWTP) commissioned in 2006 and is used to treat both foul sewer and trade effluent. Both networks serve the entire site through a conveyance system draining to the WWTP to the south-east of the site (see Plate 3.1 for location). Wastewater from the foul sewer and trade effluent networks, enter the WWTP through and an influent wet well. Initial treatment is with a drum screen to remove larger solids. Following screening, the wastewater enters one of two balance tanks which are equipped with propellers and agitators. Following physical treatment, the wastewater undergoes aerobic biological treatment followed by effluent polishing using ozone oxidation. The intent behind biological treatment is to reduce the wastewater bulk organic fraction and in doing so, minimize the downstream ozone demand. MBR technology (biological treatment coupled with ultrafiltration) is in place to yield a high quality effluent devoid of suspended solids and solids-associated APIs. Some removal of certain APIs occurs in the biological system. Ozone oxidation is used to remove APIs that passed through the biological system. The resultant treated wastewater stream (Emission Point Reference No. SE1) is pumped to the tiein with the Kildare County Council municipal sewer. Effluent discharged through this route is monitored in accordance with Schedule C.3.2 of Licence Register No. P Doherty Environmental 8 12/09/2018

12 The Annual Environmental Reports (AERs) for 2010 to 2017 have been reviewed and no exceedances in the emission limit values (ELVs) for all wastewater parameters have been recorded during each year of monitoring. During 2017 integrity tests of the wastewater pipework detected a drop in hydraulic pressures along the pipework. The pipework was repaired within 24 hours of detection of the initial test failure. As all ELVs were complied with there was no potential for the project site to result in the release of contaminated wastewater prior to the detection of the test failure. 3.6 STORM WATER DRAINAGE & CONTAINMENT Surface water generated from a rainfall event is collected through systems of storm water drains networked around the Pfizer site from building roofs, roads and all hard standing areas. The storm water systems are fitted with oil interceptors and flow underground directly to the site surface water discharge point (Emission Point Reference No. SW1), prior to discharge to the municipal surface water drainage system which in turn discharges to the River Liffey. Also located on the site is a 1,400m 3 surface water attenuation tank (to ensure that potential surges of water to the on-site surface water drainage system and subsequent surcharging of the municipal storm water sewer is prevented), which is connected to the surface water network from specific areas of the site and drained through SW1. There is a continuous TOC (Total Organic Carbon) monitor located at the SW1 discharge point, with all other specified parameters monitored periodically in line with the requirements of Schedule C.2.3 of Licence Register No. P The surface water penstock will be activated if the TOC analyser detects dissolved organic substances above an action set point value which has been agreed with the EPA or if the sprinkler system is activated. No issues have been detected either through visual controls or through continuous TOC monitoring. Monitoring results reviewed for 2010 to 2017 (as per AERs) indicate that the surface water discharge from the Pfizer facility at SW1, the surface water outfall point, is of good chemical quality, and surface water discharging from the site is not resulting in impacts to the receiving waters into which it ultimately discharges (i.e. River Liffey). Doherty Environmental 9 12/09/2018

13 3.7 CONTAINMENT OF SPILLS & LEAKS All bulk solvents used and generated on site are stored in above ground tanks in the Solvent Tank Farm which are located in bunds. These solvents are transferred to/from the process area in high integrity steel pipework. Liquid process materials in smaller quantities are stored in drums or intermediated bulk containers, which are stored in bunded Chemstores in designated outdoor impermeable paved areas (pads) or in the Solvent Storage Area located within Building 4 (see Plate 3.1 for location). Spill kits, containing absorbent materials, are stored strategically around the site and relevant staff are trained in the appropriate emergency response actions to take in the event of a spill or leak. If a spill or leak were to occur that is not contained at source, it is collected in either the process wastewater or the storm water drainage systems, depending on the location of the spill or leak. It is anticipated that any spill or leak that could occur cannot easily enter the ground or the groundwater across the site. If spilled or leaked process materials enters the storm water drainage system they would be detected by the continuous TOC monitoring system, as described in Section 3.6, and the penstock would automatically close thereby preventing discharge from the site. This retained surface water would be further analysed to determine the nature and extent of contamination and establish an appropriate means of disposal. If spilled or leaked process materials enter the process wastewater drainage system, they would drain to the waste water treatment plant and would be fully treated on site. 3.8 CONTAINMENT IN THE EVENT OF A FIRE Fire water retention facilities have been provided on site, which have sufficient capacity to contain the potentially contaminated runoff from a fire event from the identified high risk area (i.e. Solvent Tank Farm) combined with rainfall, in compliance with the requirements of the EPA s guidance on fire water retention, Fire-Water Retention Facilities (Draft) Guidance Note To Industry On The Requirements For Fire-Water Retention Facilities, EPA In the event of a fire on site at other areas, water used for fire-fighting initially enters the site surface water network where it would be retained (due to closure of penstock which occurs on Doherty Environmental 10 12/09/2018

14 activation of the sprinkler system) and subsequently pumped to the firewater retention tank for containment until an appropriate treatment route is determined e.g. discharge to the WWTP or off-site disposal. During integrity testing of the fire retention area, a failure was recorded in one of the bunded areas. This bund was taken out of active use until the first quarter of 2018 while repairs and further integrity testing was completed. The issues with the bund have now been rectified. 3.9 EMISSIONS TO ATMOSPHERE ABATEMENT The primary contaminants of air streams at the facility comprise of particulates and Volatile Organic Components (VOCs). Particulates may contain Active Pharmaceutical Ingredients (APIs). Particulate emissions occur mainly as a result of tablet manufacture and to a lesser extent from the tablet packaging process. Emissions are minimised through employing a combination of control and abatement measures. Particulates: Typically, tablet manufacturing process equipment is enclosed with built-in extraction systems. Tablet manufacture and tablet packaging areas also employ house cleaning vacuum systems. For both types of extraction systems, dusts are collected in a combination of cartridge/high Efficiency Particulate Air (HEPA) filters. These filters are designed to capture at least 99.97% of 0.3 m sized particles. To ensure effective operations, differential pressure across the filters is continuously monitored with fault situations (filter blockage/breach) addressed in a timely manner. VOCs: VOCs are produced as a result of solvent use, primarily in tablet manufacture. Both Dichloromethane (DCM) and Methanol are used as carrier agents for the coating material during the coating process of certain products. In order to prevent any emissions to atmosphere, the waste vent gases are vented to the solvent abatement system. Waste solvent generated during this process is recovered through a solvent condensing system. This solvent is then collected on site as hazardous waste and removed by the sites approved waste management company for treatment. Doherty Environmental 11 12/09/2018

15 Site boilers, which operate on natural gas, are fitted with burners to reduce the formation of NOx during the combustion process (low NOx burners). The site has been designed to minimise potential sources of fugitive emissions arising from process areas and buildings i.e. minor leakages from connections, isolation and control valves, relief valves, equipment seals, analysers and solvent dispensing operations. Dust emissions are vented to specific extract systems and house cleaning vacuum systems. Fugitive solvent emissions are minimised by the closed loop systems of the primary solvent coating process (associated with the Efexor process) and dedicated solvent recovery and abatement system on-site. Good housekeeping practices, including preventative maintenance and routine monitoring of equipment on-site minimises the potential for any equipment leaks. 4.0 THE PROJECT & EUROPEAN SITE BASELINE 4.1 IDENTIFICATION OF EUROPEAN SITES Current guidance on undertaking EU Habitats Directive Article 6 Assessments advises that all European Sites occurring within a 15km radius of a project site should be included within a Screening Assessment (Scott Wilson et al., 2006; DEHLG, 2010). Six European Sites, comprising of five SACs and one SPA occur within the surrounding 15km radius of the site (see Figure 4.1; Table 4.1 for list of European Sites). In addition to the European Sites occurring within a 15km area of the project site the DEHLG 2010 guidelines also advise that where the potential exists for a hydrological pathway to occur between the project site and European Sites beyond the 15km distance, then these sites should also be included as part of the Screening Assessment. The River Liffey, which receives both treated surface water and wastewater from the project site drains to Dublin Bay, where a number of European Sites are located. A total of four Doherty Environmental 12 12/09/2018

16 European Sites are located at Dublin Bay. These European Sites are shown in Figure 4.2 and listed Table 4.1. As the nearest European Site (Mouds Bog SAC) is located at a remote distance from the project site, approximately 2km to the northwest as the crow flies, the project will not have the potential to result in direct impacts to European Sites. Thus this Screening exercise focuses on investigating whether the project will have the potential to result in indirect effects to European Sites or effect mobile species associated with European Sites beyond the boundaries of their designated conservation areas. A source-pathway-receptor model has been used to establish which European Sites could occur within the sphere of influence of potential indirect impacts. Under such a model the project, as described in Section 3 of this Screening Report, represents the source. Potential impact pathways are restricted to hydrological and aerial pathways as these represent the principal emissions generated by activities at the project site. The receptors represent European Sites and their associated qualifying features of interest. European Sites and their associated qualifying features are likely to occur in the sphere of influence of the project only where hydrological or aerial pathways establish a link between the project and the European Site. Table 4.1 provides a determination as to whether each European Site within a 15km buffer distance of the project site occur within the sphere of influence of the project. This determination has been undertaken in line with the following assessment questions: Is there a hydrological pathway linking the Project site to European Sites and does this pathway have the potential to function as an impact pathway? Is there an aerial pathway linking the Project site to European Sites and does this pathway have the potential to function as an impact pathway Does the project site have the potential to interact with Annex II qualifying species/ special conservation interest species of these European Sites? Doherty Environmental 13 12/09/2018

17 Doherty Environmental 14 12/09/2018

18 Doherty Environmental 15 12/09/2018

19 Table 4.1: Assessment to Determine whether European Sites occur within the Projects Sphere of Influence European Distance Is there a Hydrological Pathway and Is there an Aerial Pathway and does Do the Project have the potential Do European Sites occur Sites from does it have the potential to function it have the potential to function as an to interact with Mobile Species within the Projects Mouds Bog SAC Project Site 2.2km to the northwest as an Impact Pathway Impact Pathway No. This SAC is designated for Annex 1 peatland habitats, namely raised bog, degraded raised bog and Rhynchosporion depressions. These Annex 1 habitats are ombrotrophic in nature and there is no hydrological pathway linking these habitats or this SAC to the project site. No. An air dispersion modelling study (ARUP, 2018) has been completed for the project. This study assessed the potential impact of dust emissions of the Active Pharmaceutical Ingredient (API) Hormone Treatment (HT), and non-hormonal dust (i.e. Particulate Matter (PM)). The study found that exposure to HT a active concentrations No. No Annex 2 species are listed as qualifying features of interest for this SAC. Sphere of Influence? No. No potential impact pathways link the project site to this SAC. will be exceedingly low for any individual in the vicinity of the Pfizer facility, and many orders of magnitude below the therapeutic dose level. No Doherty Environmental 16 12/09/2018

20 significant impact on air quality is predicted as a result of PM emissions associated with the project and all air quality standards will be complied with. In light of the findings of the Air Dispersion Modelling study, it can be concluded that the no potential aerial pathway exists between the project site and European Sites in the surrounding area and that emissions associated with the project will not have the potential to impact the Conservation Objectives and status of these European Sites. Pollardstown 3km to the No. This SAC is designated for the No. See reasons outlined for Mouds No. This SAC is designated for its No. No potential impact Fen SAC west presence of the Annex 1 habitats Bog SAC above. role in supporting three species of pathways link the project calcareous fens, alkaline fens and the Annex 2 Vertigo snails. These site to this SAC. petrifying spring. Both habitats rely on species are predominantly Doherty Environmental 17 12/09/2018

21 soligenous hydrological processes. There are no surface water or groundwater pathways linking the project site to this SAC and its associated Annex 1 qualifying habitats. sedentary in nature and there will be no potential for them to interact with the project site and associated activities at the project site. Ballynafagh Lake SAC 9km to the north No. This SAC is designated for the presence of the Annex 1 habitat alkaline fens. This habitat relies on soligenous hydrological processes. There are no surface water or groundwater pathways linking the project site to this SAC and its associated Annex 1 qualifying habitat. No. See reasons outlined for Mouds Bog SAC above. No. This SAC is designated for its role in supporting populations of the Annex 2 species marsh fritillary butterfly and Vertigo moulinsiana. No suitable habitat for either species occurs in the vicinity of the project and there are no indirect impacts linking the project to the populations of these species No. No potential impact pathways link the project site to this SAC. supported by this SAC. Ballynafagh 11km to the No. This SAC is designated for Annex 1 peatland habitats, namely raised bog No. See reasons outlined for Mouds No. No Annex 2 species are listed as qualifying features of interest for No. No potential impact pathways link the project Doherty Environmental 18 12/09/2018

22 Bog SAC north and Rhynchosporion depressions. Bog SAC above. this SAC. site to this SAC. These Annex 1 habitats are ombrotrophic in nature and there is no hydrological pathway linking these River Barrow and River Nore SAC 13.5km to the southwest habitats or this SAC to the project site. No. This SAC is designated for a range of lotic, riparian and coastal Annex 1 habitats. This SAC and its associated qualifying habitats are located at a remote distance from the project site and occur within a separate surface water No. See reasons outlined for Mouds Bog SAC above. No. This SAC is designated for its role in supporting Annex 2 freshwater species and the sedentary Killarney fern. This SAC and its associated qualifying species are located at a remote distance from the project No. No potential impact pathways link the project site to this SAC. catchment. As such there is no site and occur within a separate potential for a hydrological impact surface water catchment. As such pathway to occur. there is no potential for an impact pathway to occur between the project site and populations of these Doherty Environmental 19 12/09/2018

23 species supported by this SAC. Poulaphouca 14.7km to No. The wetland habitats associated No. See reasons outlined for Mouds No. This SPA is designated for its No. No potential impact Reservoir the southeast with this SPA are located at a remote Bog SAC above. role in supporting populations of pathways link the project SPA distance upstream from the project site. No hydrological pathway links the project site and associated activities to the wetland habitats of this SPA. greylag goose and lesser blackbacked gull. No suitable habitat for these species occur in the vicinity of the project site and there will be no potential for the project and its associated activities to interact with the populations of these species supported by this SPA. Furthermore there is no potential for an impact pathway site to this SPA. (hydrological or aerial) to link the project and associated activities to populations of these species at this SPA. Doherty Environmental 20 12/09/2018

24 South 65km Yes, there is a hydrological pathway. No. See reasons outlined for Mouds No. No Annex 2 species are listed No. No potential impact Dublin Bay downstream This SAC is designated for the Bog SAC above. as qualifying features of interest for pathways link the project SAC and to the presence of coastal Annex 1 habitats. this SAC. site to this SAC. east Treated wastewater and surface water from the project site eventually discharge to the River Liffey and as shown on Figure 5.2, the River Liffey forms a hydrological pathway between the project site and this SAC. However this hydrological pathway does not function as a potential impact pathway for the following reasons: This SAC is located approximately 65km downstream from the project site. All wastewater generated at the project site undergoes treatment within the onsite WWTP prior to discharge to the Doherty Environmental 21 12/09/2018

25 municipal sewer. The effluent discharged from the onsite WWTP is routinely monitored and no exceedances in ELV s for all parameters analysed have been detected under the current industrial wastewater discharge licence for the project site (IPPC Licence No. P ). In addition the effluent discharged to municipal sewer undergoes a second round of treatment at the municipal wastewater treatment plant at Oberstown prior to final release to the River Liffey. The approach to wastewater treatment on site has to date ensured that the release of treated effluent does not have the potential to negatively affect the surface water quality of the River Liffey or Dublin Bay downstream. This Doherty Environmental 22 12/09/2018

26 approach to the treatment of wastewater will be continued as part of the proposed project. The discharge of surface water generated on site is controlled (TOC, volumetric flow) via the stormwater drainage system prior to release from the site and eventual receiving waters of the River Liffey. No issues in surface water quality for all parameters measured have been detected during routine monitoring undertaken between 2010 and The approach to surface water management on site has to date ensured that the release of surface water does not have the potential to negatively affect the surface water quality of the River Liffey or Dublin Bay Doherty Environmental 23 12/09/2018

27 downstream. This approach to the treatment of surface water will be continued as part of the proposed project. As outlined in Section 3 above infrastructure is in place at the project site to contain and treat fire water. As such the potential for firewater to be released from the project site is very low. In summary, the measures in place at the project site are proven to be effective in ensuring that activities at the project site, including those proposed under the current project, do not have the potential to result in adverse effects to the water quality of the River Liffey. This in turn ensures that the River Liffey will not function Doherty Environmental 24 12/09/2018

28 as a potential impact pathway linking the project site and associated activities to this SAC. North Dublin Bay SAC North Bull Island SPA 65km downstream and to the east 65km downstream Yes there is a hydrological pathway, but this pathway does not have the potential for function as an impact pathway for reasons outlined for South Dublin Bay SAC above. No. See reasons outlined for Mouds Bog SAC above. Yes there is a hydrological pathway, No. See reasons outlined for Mouds but this pathway does not have the Bog SAC above. No. This SAC supports a population of the liverwort Petalophyllum ralfsii. This is a sedentary species and there is no potential for the project to interact with this species. No. This SPA is designated for its role in supporting a number of No. No potential impact pathways link the project site to this SAC. No. No potential impact pathways link the project and to the potential for function as an impact wetland bird species. Individuals site to this SPA. east pathway for reasons outlined for South associated with the SPA Dublin Bay SAC above. populations of these species are very unlikely to occur in the vicinity of the project site and there Doherty Environmental 25 12/09/2018

29 is no potential impact pathway (hydrological or aerial) linking the project site to the foraging and roosting ground upon which these species rely. South Dublin Bay & Tolka Estuary SPA 65km downstream and to the east Yes there is a hydrological pathway, but this pathway does not have the potential for function as an impact pathway for reasons outlined for South Dublin Bay SAC above. No. See reasons outlined for Mouds Bog SAC above. No. This SPA is designated for its role in supporting a number of wetland bird species, including breeding terns. Individuals associated with the SPA populations of these species are very unlikely to occur in the vicinity of the project site and there is no potential impact pathway (hydrological or aerial) linking the No. No potential impact pathways link the project site to this SPA. project site to the foraging, nesting and roosting ground upon which these species rely. Doherty Environmental 26 12/09/2018

30 Table 4.1 above shows that the six European Sites occurring within a 15km radius of the project site and the four European Sites occurring downstream at Dublin Bay do not occur within the sphere of influence of the project site. The Source-Pathway-Receptor model has not identified the presence of an impact pathway, be it hydrological, aerial or mobile species, linking the project site to European Sites in the wider surrounding area. The absence of any potential impact pathways, coupled with the approach to the management of operations and emissions generated at the project site will ensure that this project does not have the potential to result in likely significant effects to European Sites or the local environment surrounding the project site. A Screening Matrix, in line with European Commission (2001) guidelines is provided below in Table 4.2. Table 4.2: Screening Matrix for proposed project. Brief description of the project or plan Brief description of the European Sites Describe the individual elements of the project (either alone or in combination with other plans or projects) likely to give rise to impacts on the European Sites. Describe any likely direct, indirect or secondary impacts of the project (either alone or in combination with other plans or projects) on the European Sites site by virtue of: The project and associated activities are described in Section 2 above. The European Sites occurring in the wider surrounding area are identified and briefly described in Section 4 above. The elements of the project that could (conceivably) size and scale; land-take; distance from the Natura 2000 site or key features of the site; resource requirements (water abstraction etc.); emissions (disposal to land, water or air); excavation requirements; transportation requirements; duration of construction, operation, give rise to potential environmental effects relate to atmospheric, wastewater and surface water emissions arising from the project site and associated activities. The project will not have the potential to result in direct, indirect or secondary impacts to European Sites. As the project is not predicted to result in the emission of potentially polluting substances to the surrounding environment it will not have the potential to combine with other projects in the surrounding area to result in cumulative significant effects to the local environment or European Sites occurring in the wider surrounding area. Doherty Environmental 27 12/09/2018

31 decommissioning, etc.; Describe any likely changes to the site arising as a result of: reduction of habitat area: disturbance to key species; habitat or species fragmentation; reduction in species density; changes in key indicators of conservation value (water quality etc.); climate change. As the project is not predicted to result in the emission of potentially polluting substances to the surrounding environment it will not have the potential to result in changes to qualifying habitats or qualifying species of European Sites occurring in the wider surrounding area. Describe the potential for the project alone or in The project will not have the potential to combination with other plans or projects to result combine with other plans or projects to result in in likely significant effects to European Sites. in likely significant effects to European Sites. The emissions from the project site relate to air and process wastewater. Existing treatment and management systems are in place at the Pfizer Newbridge site that effectively treat all airand process wastewater generated at the project site prior to release to the environment. Ongoing monitoring of the treatment systems on site have shown that all emissions from the project site are consistently within the licenced ELV s and no exceedances in these limits have been recorded during ongoing monitoring at the project site. Given the above, the project will not have the potential to result in the release of emissions to the environment that could combine with other sources of such emissions to result in adverse environmental effects. Describe any likely impacts on the European Sites For reasons set out above the project will not site as a whole in terms of: have the potential to interfere with key interference with the key relationships that define relationships that define the structure and the structure of the site; function of European Sites. interference with key relationships that define the function of the site Doherty Environmental 28 12/09/2018

32 Provide indicators of significance as a result of the identification of effects set out above in terms of: loss; fragmentation; disruption; disturbance; change to key elements of the site (e.g. water quality etc.). For reasons set out above the project will not have the potential to result in such effects to European Sites. Describe from the above those elements of the project or plan, or combination of elements, where the above impacts are likely to be significant or where the scale or magnitude of impacts is not known. The project will not have the potential to result in likely significant effects to European Sites. 5.0 SCREENING STATEMENT CONCLUSION: FINDING OF NO SIGNIFICANT EFFECTS During the Screening of the proposed project and change in use of manufacturing suites in Buildings 3A and 4-2 (to facilitate the manufacture of the Eliquis product and other similar drug products) at the Pfizer Ireland Pharmaceuticals facility at Newbridge it was found that six European Sites occur within a 15km radius of the project site and an additional four European Sites occur at a greater distance (i.e. 65km) downstream. The nearest European Site to the project site is located over 2km to the northwest. All of these European Sites (and their associated qualifying features of interest/special conservation interests) are adjudged to be located outside the sphere of influence of all activities associated with the proposed project. No impact pathways were identified linking the wider Pfizer project site to the surrounding European Sites. In light of the findings of this Screening for Appropriate Assessment it is concluded that the project will not have a significant negative effect on European Sites and will not negatively affect their conservation objectives or integrity. Doherty Environmental 29 12/09/2018

33 This Screening has resulted in a Finding of No Significant Effects and as such a Stage II Appropriate Assessment is not required. REFERENCES ARUP (2018). Air Dispersion Modelling Study of Revised Emissions. Pfizer Newbridge: IE Licence Register No. P Department of the Environment Heritage and Local Government (DEHLG) (2008) Circular letter SEA 1/08 & NPWS 1/08. Department of the Environment Heritage and Local Government (DEHLG) (2010). Appropriate Assessment of Plans and Projects. Guidance for Local Authorities. English Nature (1999). Habitats regulations guidance note no. 3 (HRGN No. 3). Determination of Likely Significant Effect under The Conservation (Natural Habitats &c) Regulations Environment Agency, Environmental statement for the Humber Estuary Tidal Defences. Urgent works, Paull to Kilnsea and Whitton to Pyewipe. European Commission (2000). Managing Natura 2000 sites. The provisions of Article 6 of the Habitats Directive 92/43/EEC. Luxembourg. European Commission (2001). Assessment of plans and projects significantly affecting Natura 2000 sites. Methodological guidance on the provisions of Article 6(3) and (4) of the Habitats Directive 92/43/EEC. Luxembourg. European Commission (1992). EU Habitats Directive. Doherty Environmental 30 12/09/2018

34 Doherty Environmental 31 12/09/2018