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1 Pfizer Biotechnology Ireland Pfizer Monoclonal Antibodies Small Scale Facility IPPC Licence Application ATTACHMENT I.5 Hydrogeological Desk Study (URS 2008) J:\C2000-C2099\C2054\3) DOCUMENTS\40\REPORTS\IPPC LICENCE APPLICATION\IPPC ISSUE\PFIZER BIOTECHNOLOGY IPPC ATTACHMENT I.5.DOC Attachment I.5 Page 1 Arup Consulting Engineers 24 September 2008

2 Pfizer Ireland Pharmaceuticals - IPPC Licence Support Task 1 - Hydrogeological Desk Study Issue No /

3 Project Title: Report Title: Pfizer Ireland Pharmaceuticals - IPPC Licence Support Project No: Report Ref: Status: Client Contact Name: Client Company Name: Issued By: Peter Cudden Pfizer Ireland Pharmaceuticals URS Ireland Euro Business Park Little Island Cork Ireland Tel: Fax: Document Production / Approval Record Issue 1 Prepared by Checked by No: Name Signature Date Position Edel O'Hannelly Kevin Forde 22 August August 2008 Senior Hydrogeologist Technical Director Approved by Kevin Forde 22 August 2008 Technical Director Document Revision Record Issue No Date Details of Revisions 1 22/08/2008 Original issue

4 CONTENTS Section Page No 1. INTRODUCTION Background Objectives SITE SETTING Site Location Topography Hydrology Geology Hydrogeology CONCLUSIONS... 7 Page i

5 1. INTRODUCTION 1.1 Background URS Ireland Limited (URS) is pleased to present this report on the hydrogeological desk study on the Pfizer Biotechnology Ireland site at Shanbally, Ringaskiddy, County Cork, Ireland, undertaken on behalf of Pfizer Ireland Pharmaceuticals (Pfizer). This report has been prepared in accordance with URS proposal dated 08 August 2008 and authorised by Pfizer under their purchase order number N It is understood that Pfizer Biotechnology Ireland have acquired the former ADM facility at Shanbally and are developing a portion of the site as a pilot scale biopharmaceutical production facility, with the potential for future expansion. It is further understood that the proposed development will operate a largely aqueousbased production process and solvent storage and use will involve isopropanol (IPA), ethanol, caustic and acids in relatively small quantities (drum storage rather than bulk storage). 1.2 Objectives The aim of this report is to satisfy the requirement to include an assessment of the site s hydrogeological setting for inclusion with the application for an Integrated Pollution Prevention and Control (IPPC) licence for the new development to be submitted to the Environmental Protection Agency (EPA). Page 1

6 2. SITE SETTING 2.1 Site Location The site is located at a national grid reference of W , approximately 11 km southeast of Cork city centre, 3 km north-east of Carrigaline town centre and 1 km north-west of Ringaskiddy village. The site location is illustrated in Figure 1. The site is situated in an area of industrial development. The following industrial sites are located within 1 km of the Pfizer Biotechnology site: Pfizer Ringaskiddy API pharmaceutical production plant, located immediately east of the site (IPPC licence number P ); Centocor Biologics (Ireland) Limited biopharmaceutical facility is being developed immediately to the south of the site (IPPC licence number P ); Novartis pharmaceutical production plant is located 750 m to the south (IPPC licence number P ); Recordati Ireland Limited pharmaceutical production plant is approximately 1 km to the south (IPPC licence number P ); Carbon Chemicals Group food ingredients and chemical-related production and distribution facility is approximately 1 km to the south; Enva Ireland Limited waste transfer station is approximately 750 m to the west (Waste Licence number W ); Cork County Council Rafeen Landfill and Civic Amenity site is approximately 1 km to the north west (Waste Licence number W ); Cork Deep Water Port at Ringaskiddy, approximately 1 km east of the site; and Premier Molasses molasses importation and distribution facility adjacent to the Port, approximately 500 m east of the site. Remaining land use in the area is a mix of low density residential, agricultural and leisure (the Pfizer Sports and Social Club golf course is located immediately beyond the western site boundary). The site was originally developed in 1969 by Pfizer to produce food chemicals, including citric acid and gluconate products. In 1972 Pfizer began to develop a series of organic synthesis plants in the east of the site for pharmaceutical production. In 1990, Pfizer sold its worldwide citric acid business to Archer Daniels Midland (ADM) and the western portion of the original Pfizer site, which contained the food chemical production facilities, was transferred to the ADM business. Page 2

7 ADM Ringaskiddy submitted an IPC licence application in 1995, which was granted (IPC licence number P053-01). The site ceased operation in 2006 and was acquired by Corrin MDA Ltd., who demolished the majority of the ADM production plant. The site was then acquired by Pfizer in 2007, who plan to redevelop the site as a biotechnology plant, with the initial phase of development being a pilot scale plant. 2.2 Topography The site is at an average elevation of approximately 15 m above Ordnance Datum (OD). Across the site ground slopes from south-west to north-east down to Monkstown Creek, a tidal inlet of Cork Harbour, which forms the northern boundary of the site. Immediately south of the site (on the southern side of the N28 road) is an east-west trending ridge, which reaches a maximum elevation of 53 m above OD. 2.3 Hydrology 2.4 Geology There are no surface water bodies within the site boundary. The nearest surface water body is Monkstown Creek, a tidal inlet through which the Glounatouig Stream, flowing from west to east through Rafeen village, enters Cork Harbour. There are no data available with regard to the water quality of Glounatouig Stream, however Cork Harbour is classified by the EPA as being of Intermediate Quality ( Subsoil Geology The subsoils consist of a layer of glacial sediments comprising stiff, reddish brown, silty, sandy clay with gravel up to boulder size. The gravel and boulders consist of sandstone, shale and limestone. The sediments can also contain random pockets and lenses of cleaner sand and gravel, while around the edge of the ridge to the south, larger areas of fluvio-glacial or marginal moraine sands and gravels occur. The subsoil sediments vary in thickness across the site, due primarily to the irregular nature of the underlying limestone bedrock surface. Results of trial pitting at the site in 2008 (IGSL, Geotechnical Investigation Report 13140, February 2008) found the sediment thickness to range from 0.5 m to 4.9 m below ground level, although the shallower trial pits were terminated because they encountered concrete or made ground, rather than bedrock. However, limestone bedrock outcrops along a small east-west ridge close to the northern site boundary with Monkstown Creek. The maximum thickness of overburden encountered in rotary boreholes drilled at the site in 2008 was 9.5 m (close to the southern site boundary). The rotary boreholes indicate that the depth to bedrock increases from north to south across the site. Page 3

8 The previously developed areas of the site are also covered in varying thickness of made ground (fill material), reportedly up to 4 m in thickness in the area immediately south of the water tanks Bedrock Geology Geological Survey of Ireland (GSI), Bedrock Geology 1:100,000 Sheet 25 indicates that the site is underlain by the Waulsortian limestone formation, a massive unbedded fine grained limestone, which is commonly karstified in the Cork area. In the area of the site, the limestone is reported to be folded. An east-west trending fault immediately south of the site (roughly concurrent with the N28 road) juxtaposes the limestone bedrock beneath the site against younger sandstones and shales of the Kinsale Formation, which form the east-west topographic ridge immediately south of the site. A total of seventeen rotary cored boreholes were drilled across the site in 2008 by IGSL. Limestone bedrock was encountered at all drilling locations. In some locations the limestone was heavily fractured and weathered, consisting of cobbles and boulders to over 12 m in thickness. At one drilling location (RC15) heavily weathered limestone bedrock was present to 20 m below ground level and the depth to competent bedrock was not proven. This is consistent with the known characteristics of Waulsortian limestones as they are prone to solution weathering and karstification. Solutional weathering exploits existing weaknesses in the rock, such as fractures created initially through folding or faulting events. This type of solutional weathering can give rise to open voids, enlarged fracture, caverns and clay in-filling of fractures. 2.5 Hydrogeology Regional Groundwater Use Limestone bedrock beneath the site is classified by the GSI as a Locally Important Karstic aquifer with Extreme to High Vulnerability, given the presence of bedrock close to the surface. According to the GSI database ( there are many wells within 1 km of the site, mostly located across-gradient to the west. The GSI database does not indicate for what purpose these wells are used, or if they are still in use. Typical uses for such wells are domestic, agricultural or industrial supply. It should be noted that the GSI database is not a definitive record, there may be additional wells in the area that are not recorded on the database. However, there are no records to indicate the presence of a Source Protection Zone in the vicinity of the site, indicating that there are no public water supply sources from groundwater in the area of the site. Page 4

9 2.5.2 Groundwater Flow Given the site s location and topography, groundwater is expected to flow from southwest to north-east across the site, with groundwater discharge predominantly occurring along the northern site boundary directly to Monkstown Creek (where bedrock outcrops at the shoreline and groundwater seepages have been noted on the foreshore at low tide) or further to the east via flow through the Pfizer Ringaskiddy API facility to Monkstown Creek. During the geotechnical works undertaken by IGSL in early 2008 it was noted that groundwater was not encountered at all drilling locations. At those locations where groundwater was encountered, the depth to standing groundwater ranged from 4.5 m to 10 m below round level (after groundwater conditions had been allowed to equilibrate). Flow through Waulsortian limestone is expected to be predominantly through shallow weathered horizons and solutionally-enlarged fracture zones, as the rock has negligible matrix porosity. The productivity of wells drilled into Waulsortian limestone is dependent on the borehole intersecting water-bearing fractures that are well-connected to other fractures. If a borehole is drilled into a solid block of limestone with no fractures, or fractures that have not been solutionally enlarged, then the well will have a poor yield. It is difficult to predict where a productive zone of a fractured or karstified aquifer will be encountered, hence the GSI classification of a Locally Important Aquifer, i.e. a poor aquifer that is productive only in localised zones Groundwater Monitoring The site is to be developed as a biotechnology facility, with a pilot plant developed initially. The biopharmaceutical production processes are predominantly aqueous based and the site will use readily degradable organic and inorganic chemicals, principally isopropyl alcohol, ethanol, caustic and acids. Relatively small quantities of these chemicals will be required, therefore chemicals will be stored in small volume containers (such as drums or IBCs) in secondarily contained storage areas (bunds or drum trays), rather than utilising bulk tank storage of chemicals. Though the aquifer beneath the site is not regionally important and not known to be used as a drinking water or industrial process supply resource in vicinity or downgradient of the site, it is classified as being extremely vulnerable to surface-derived contamination and the groundwater flow path is relatively short and discharges to Cork Harbour at Monkstown Creek. Given that chemicals of limited environmental concern will be used and stored on site, albeit readily biodegradable chemicals in relatively small quantities, it is proposed to install a groundwater monitoring network across the pilot plant site to monitor groundwater quality. The proposed groundwater monitoring network for the pilot plant will consist of three monitoring wells, one located on the up-gradient (south-west) side of the pilot plant, with two wells on the down-gradient sides (north and east). The boreholes will be drilled into Page 5

10 bedrock and will be installed as permanent monitoring wells, with discrete screen sections to allow groundwater inflow. Page 6

11 3. CONCLUSIONS The Pfizer Biotechnology Ireland pilot plant site at Shanbally, County Cork is located in a mixed land use area and the site has been used as an industrial site since The proposed development of a biopharmaceutical production facility at the site will entail the use of largely aqueous-based processes and will use relatively small quantities of readily biodegradable organic and inorganic chemicals. Groundwater flow beneath the site is within a locally important fractured, karstified limestone bedrock aquifer. The aquifer is considered to be extremely vulnerable to contamination, give that it is present close to or exposed at the surface. The subsoils sediments, where present, consists of silty, sandy clay with gravel and boulders of glacial origin. Groundwater is not known to be used as a drinking water or industrial process supply resource in the vicinity of the site. Groundwater flow across the site is from south-west to north-east discharging to Monkstown Creek to the north and north-east of the site. Page 7

12 LIMITATIONS URS Ireland Limited (URS) has prepared this Report for the sole use of Pfizer Ireland Pharmaceuticals in accordance with the Agreement under which our services were performed. No other warranty, expressed or implied, is made as to the professional advice included in this Report or any other services provided by us. This Report may not be relied upon by any other party without the prior and express written agreement of URS. Unless otherwise stated in this Report, the assessments made assume that the sites and facilities will continue to be used for their current purpose without significant change. The conclusions and recommendations contained in this Report are based upon information provided by others and upon the assumption that all relevant information has been provided by those parties from whom it has been requested. Information obtained from third parties has not been independently verified by URS, unless otherwise stated in the Report. COPYRIGHT This Report is the copyright of URS Ireland Limited. Any unauthorised reproduction or usage by any person other than the addressee is strictly prohibited. Page 8

N SITE LOCATION PFIZER API NOVARTIS RECORDATI 0 1 2 km APPROXIMATE SCALE GOVERNMENT OF IRELAND OS LICENCE No EN 0001901 Title Location Client SITE LOCATION SHANBALLY, RINGASKIDDY PFIZER BIOTECHNOLOGY

14 N SITE LOCATION PFIZER API NOVARTIS RECORDATI km APPROXIMATE SCALE GOVERNMENT OF IRELAND OS LICENCE No EN Title Location Client SITE LOCATION SHANBALLY, RINGASKIDDY PFIZER BIOTECHNOLOGY IRELAND LTD. App'd TI App'd EO H Reference KF/EO H/COR Job No Euro Business Park Little Island Cork Ireland Tel: (0) Fax: (0) Date AUG 08 Scale AS SHOWN FIGURE 1

3.0 GEOLOGY AND HYDROGEOLOGY

3.0 GEOLOGY AND HYDROGEOLOGY 3.1 Methodology The Geological Survey of Ireland (GSI) publication Geology of South Cork was consulted to establish the nature of the bedrock lithology and Quaternary sediments.