Proposed extension to the Elanco Animal Health Facility ... · Proposed extension to the Elanco Animal Health Facility, Sligo

Proposed extension to the Elanco Animal Health Facility Sligo, Co. Sligo Environmental Impact Statement Volume 2 – Main Report October 2010

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Proposed extension to the Elanco Animal Health Facility, Sligo Environmental Impact Statement Volume 2 – Main Report

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Contents 1.0 INTRODUCTION .......................................................................................................................... 1

1.1 The Project ................................................................................................................................ 1 1.2 EIA Legislation and Requirements............................................................................................ 1 1.3 EIA Objectives and Process...................................................................................................... 1 1.4 EIS Structure ............................................................................................................................. 2 1.5 Project Team ............................................................................................................................. 3

2.0 ENVIRONMENTAL ASSESSMENT PROCESS.......................................................................... 4 2.1 Introduction................................................................................................................................ 4 2.2 Screening .................................................................................................................................. 4 2.3 Aims of the Assessment............................................................................................................ 4 2.4 Outline of EIA Principles ........................................................................................................... 5 2.5 The EIA Scoping Process ......................................................................................................... 8 2.6 Scoping – Environmental Aspects ............................................................................................ 9 2.7 Conclusions............................................................................................................................. 14

3.0 CONSIDERATION OF ALTERNATIVES................................................................................... 15 3.1 Introduction.............................................................................................................................. 15 3.2 Examination of Alternative Options ......................................................................................... 15 3.3 Existing Site Analysis .............................................................................................................. 15 3.4 Masterplanning........................................................................................................................ 18 3.5 Proposed Extension Description ............................................................................................. 20

4.0 PLANNING AND LEGISLATIVE FRAMEWORK ...................................................................... 22 4.1 Introduction.............................................................................................................................. 22 4.2 Site Location & Context........................................................................................................... 22 4.3 Planning History ...................................................................................................................... 23 4.4 National Planning Context....................................................................................................... 23 4.5 Regional Planning Context...................................................................................................... 24 4.6 Local Planning Context ........................................................................................................... 25 4.7 Conclusions............................................................................................................................. 27

5.0 PROJECT DESCRIPTION ......................................................................................................... 29 5.1 Site Location, History & Context ............................................................................................. 40 5.2 Project Background ................................................................................................................. 40 5.3 Construction Phase Overview................................................................................................. 40 5.4 Operational Phase Overview .................................................................................................. 40

6.0 SOCIO ECONOMIC ................................................................................................................... 41 6.1 Introduction.............................................................................................................................. 41 6.2 Methodology............................................................................................................................ 41 6.3 Description of the Existing Environment ................................................................................. 41 6.4 Impacts.................................................................................................................................... 50 6.5 Do-nothing scenario ................................................................................................................ 52 6.6 Residual Impact ...................................................................................................................... 52 6.7 Mitigation ................................................................................................................................. 52

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6.8 Conclusions............................................................................................................................. 52

7.0 ECOLOGY.................................................................................................................................. 53 7.1 Introduction.............................................................................................................................. 53 7.2 Methodology............................................................................................................................ 53 7.3 Description of Existing Environment ....................................................................................... 57 7.4 Characteristics of the Proposed Extension ............................................................................. 68 7.5 Summary of Ecological Evaluation ......................................................................................... 68 7.6 Impacts.................................................................................................................................... 69 7.7 Mitigation ................................................................................................................................. 71 7.8 Residual Impacts..................................................................................................................... 72 7.9 Monitoring................................................................................................................................ 72

8.0 SURFACE WATER AND DRAINAGE ....................................................................................... 73 8.1 Introduction.............................................................................................................................. 73 8.2 Description of the Existing Development ................................................................................ 73 8.3 Description of the Existing Environment ................................................................................. 75 8.4 Impacts.................................................................................................................................... 77 8.5 Mitigation ................................................................................................................................. 78 8.6 Residual Impacts..................................................................................................................... 79 8.7 Conclusions............................................................................................................................. 79

9.0 SOILS, GEOLOGY AND HYDROGEOLOGY............................................................................ 80 9.1 Soils & Geology....................................................................................................................... 80 9.2 Hydrogeology .......................................................................................................................... 88

10.0 NOISE & VIBRATION............................................................................................................. 99 10.1 Introduction .......................................................................................................................... 99 10.2 Methodology ........................................................................................................................ 99 10.3 Legislation and Guidance .................................................................................................. 101 10.4 Description of Existing Environment.................................................................................. 103 10.5 Baseline Noise Survey ...................................................................................................... 103 10.6 Impacts .............................................................................................................................. 106 10.7 Mitigation ........................................................................................................................... 108 10.8 Residual Impacts ............................................................................................................... 109 10.9 Conclusions ....................................................................................................................... 109

11.0 AIR QUALITY AND CLIMATE ............................................................................................. 111 11.1 Introduction ........................................................................................................................ 111 11.2 Methodology ...................................................................................................................... 111 11.3 Description of the Existing Environment............................................................................ 117 11.4 Impacts .............................................................................................................................. 122 11.5 Mitigation ........................................................................................................................... 124 11.6 Residual Impacts ............................................................................................................... 125 11.7 Conclusions ....................................................................................................................... 125

12.0 LANDSCAPE AND VISUAL................................................................................................. 127 12.1 Introduction ........................................................................................................................ 127 12.2 Methodology ...................................................................................................................... 127 12.3 Landscape Planning Context ............................................................................................ 130

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12.4 Existing Environment......................................................................................................... 133 12.5 Characteristics of the Proposed Extension ....................................................................... 136 12.6 Impacts .............................................................................................................................. 136 12.7 Mitigation ........................................................................................................................... 140 12.8 Residual Impacts ............................................................................................................... 140 12.9 Conclusions ....................................................................................................................... 140 12.10 Landscape Guidelines, Information and Policy Reference ............................................... 141

13.0 CULTURAL HERITAGE ....................................................................................................... 142 13.1 Introduction ........................................................................................................................ 142 13.2 Relevant Legislation and Policy Context ........................................................................... 142 13.3 Methodology ...................................................................................................................... 143 13.4 Archaeological Heritage .................................................................................................... 144 13.5 Architectural Heritage ........................................................................................................ 146

14.0 TRANSPORTATION............................................................................................................. 150 14.1 Introduction ........................................................................................................................ 150 14.2 Methodology ...................................................................................................................... 150 14.3 Relevant Legislation and Policy Context ........................................................................... 150 14.4 Description of the Existing Environment............................................................................ 151 14.5 Proposed Development ..................................................................................................... 156 14.6 Impacts .............................................................................................................................. 156 14.7 Mitigation ........................................................................................................................... 158 14.8 Residual Impacts ............................................................................................................... 159 14.9 Conclusions ....................................................................................................................... 159

15.0 WASTE MANAGEMENT...................................................................................................... 160 15.1 Introduction ........................................................................................................................ 160 15.2 Methodology ...................................................................................................................... 160 15.3 Relevant Legislation and Policy Context ........................................................................... 160 15.4 Waste (Liquid) ................................................................................................................... 162 15.5 Description of Existing Environment.................................................................................. 162 15.6 Potential Impacts ............................................................................................................... 163 15.7 Compliance with Legislation .............................................................................................. 167 15.8 Confirmation of discharge compliance from Sligo WWTP ................................................ 167 15.9 Mitigation Measures – Wastewater ................................................................................... 167 15.10 Conclusions ....................................................................................................................... 169 15.11 Waste (Solid) ..................................................................................................................... 169 15.12 Description of the Existing Environment............................................................................ 170 15.13 Impacts .............................................................................................................................. 171 15.14 Mitigation ........................................................................................................................... 176 15.15 Conclusions ....................................................................................................................... 177 15.16 References ........................................................................................................................ 177

16.0 MATERIAL ASSETS ............................................................................................................ 178 16.1 Introduction ........................................................................................................................ 178 16.2 Methodology ...................................................................................................................... 178 16.3 Receiving Environment...................................................................................................... 178 16.4 Characteristics of the Proposed Extension ....................................................................... 179

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16.5 Impact of the Proposed Extension .................................................................................... 179 16.6 Mitigation & Monitoring ...................................................................................................... 180 16.7 Residual Impact ................................................................................................................. 180 16.8 Conclusion ......................................................................................................................... 180

17.0 INTERACTION OF THE FOREGOING AND CUMULATIVE IMPACTS ............................. 181 17.1 Introduction ........................................................................................................................ 181 17.2 Planning Context ............................................................................................................... 181 17.3 Assessment Methodology ................................................................................................. 182 17.4 Interaction of the Impacts .................................................................................................. 182 17.5 Cumulative Impacts ........................................................................................................... 183 17.6 Conclusions ....................................................................................................................... 185

18.0 SUMMARY OF MITIGATION MEASURES.......................................................................... 186

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Glossary Below is a partial glossary of terms used in this statement. The definitions therein are not to be taken as comprehensive but solely as an aid to the non-technical reader. AA Appropriate Assessment

AHU Air Handling Unit is a device used to condition and circulate air as part of a heating, ventilating, and air-conditioning (HVAC) system.

Aquifer

A subsurface layer or layers of rock or other geological strata of sufficient porosity and permeability to allow either a significant flow of groundwater or the abstraction of significant quantities of groundwater.

Alluvium Deposits from a river or stream.

Antigen A substance (as a toxin or enzyme) that stimulates an immune response in the body (especially the production of antibodies).

Archaeology The study of past societies through its surviving structures, artefacts and environmental data.

Architectural Heritage

Structures, buildings, traditional and designed, and groups of buildings including streetscapes and urban vistas, which are of historical, archaeological, artistic, engineering, scientific or technical interest, together with their setting, attendant grounds, fixtures, fittings and contents.

Autoclaved Sterilize or decontaminate of materials.

Axenic A culture of an organism that is entirely free of all other "contaminating" organisms.

Baseflow (hydrogeology)

The flow of water entering stream channels from groundwater sources.

Baseline survey A description of the existing environment against which future changes can be measured.

Bedrock Rock, usually solid, that underlies soil or other unconsolidated, superficial material.

Biological agents Bacteria, viruses, fungi, other microorganisms and their associated toxins.

Biopharmaceutical Products

Medical drugs produced using biotechnology.

Bio-synthesis An enzyme-catalyzed process in cells of living organisms by which substrates are converted to more complex products.

Biotic Processes which relate to living organisms.

Bituminous material Substances in which bitumen is present or from which it can be derived.

BOD Biochemical Oxygen Demand. c. Circa (in approximately). Cancerous (geology) As much as 50% of the rock is calcium carbonate.

Catchment That area determined by topographic features within which falling rain will contribute to run-off at a particular point under

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consideration. CIP Cleaning in Place. COD Chemical Oxygen Demand.

Conservation Status An indicator of the likelihood of that species remaining extant either in the present day or the near future.

Cumulative Impact The addition of many small impacts to create one larger, more significant, impact.

CSO Central Statistics Office.

dB(A) The term used to express a level of sound or decibel level. The (A) denotes that levels are ‘A’-weighted.

Population Demographics

Demographics are the characteristics of a human population as used in government, marketing or opinion research, or the demographic profiles used in such research.

Diffuse Flow A characterisation of some types of Karst aquifers, in which flow is distributed relatively evenly throughout the rock.

DO Dissolved Oxygen.

“Do-Nothing” Scenario The situation or environment that would exist if the extension was not carried out.

“Do-Minimum” Scenario The situation or environment that would exist if minimal intervention or development were carried out.

“Do-Something” Scenario

The situation or environment that would exist if the proposed extension is implemented.

Drift Geology Any sediment laid down by, or in association with, the activity of glacial ice.

Dry Weather Flow The annual minimum daily mean flow rate (expressed in m3/s) at a given location on a river with a probability of exceedance of 0.98 (i.e. with a return period of 50 years).

EC European Community

Environmental Impact Assessment- EIA

The process of examining the environmental effects of the proposed development - from consideration of environmental aspects at design stage through to preparation of an Environmental Impact Statement, evaluation of the EIS by the competent authority and the subsequent decision as to whether the development should be permitted to proceed, also encompassing public response to that decision.

Environmental Impact Statement- EIS

A statement of the likely significant effect, if any, which the proposed development, if carried out, is likely to have on the environment.

EIA Screening Screening is a process used to establish whether an EIA is required as part of the planning process for a proposed development.

EP Enzootic pneumonia. EPA Environmental Protection Agency.

Estuarine Environment associated with semi-enclosed coastal body of water which has a free connection with the open sea and where fresh water, derived from land drainage, is mixed with sea water.

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EU European Union Facade The face or front of a building. Fauna A collective term for the animals of a region.

Fermentation The process of growing microorganisms within an enclosed tank (fermenter) under controlled conditions of aeration, agitation, temperature, and pH.

Fissure (hydrogeology) A fracture or crack in rock along which there is a distinct separation.

Flora A collective term for the plants of a region. Fluvial Pertaining to a river. Free-field noise levels Sound radiates into space from a source uniformly in all directions

Fulacht Fiadh

Small, horseshoe shaped grass covered mounds, composed of burnt and fire cracked stones and a central pit or trough. constructed during the mid to late Bronze Age (c. 1500- c. 500 BC).

Gateway City Designation under the National Spatial Strategy (NSS). g/m3 Grams per metre cubed.

Geology Geology is the science and study of the physical matter and energy that constitute the Earth.

GHG Green House Gases.

Glacial deposits A load of rock material transported and deposited by a glacier. Glacial drift is usually deposited when the glacier begins to melt.

GMO Genetically Modified Organisms.

Gowning Room Area where operators put on the dress requirements (GMP) of the clean room /laboratory.

Groundwater vulnerability

The vulnerability to contamination of groundwater within an aquifer, or the groundwater produced by a well.

GSI Geological Survey of Ireland. ha Hectares = 10,000 square metres. HEPA Filters High Efficiency Particulate Absorbing Filters. Headroom Difference between the actual and allowed quantities. HGV Heavy Goods Vehicle. Hibernacula Locations chosen by an animal for hibernation. Hinterland Undeveloped areas.

HVAC Heating, Ventilation, and Air-Conditioning system regulates room temperature, humidity, and air flow, ensuring that such elements remain within their acceptable ranges.

Hydrogeology Is the area of geology that deals with the distribution and movement of groundwater in the soil and rocks of the Earth's crust

Hydrometric Area Grouping of catchments for monitoring and reporting purposes

Impact The degree of change in the environment resulting from the proposed extension development.

Impact Interactions The reactions between impacts on different environmental factors, whether between the impacts of just one project or between the impacts of the other projects in the area.

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Imperceptible Impact An impact capable of measurement but without noticeable consequences.

Inactivation Any process that destroys the ability of a specific microbiological agent or eukaryotic cell to self-replicate.

Indirect Impact Impacts on the environment which are not a direct result of the project, often produced away from the project or as a result of a complex pathway.

IDA Industrial Development Authority

Infrastructure Basic public facilities e.g. roads, sewers, water supply, telephones and electricity.

Inoculation Addition of an aliquot of a pure culture of microorganism to the primary seed tank to initiate fermentation.

International Ecological Significance

Areas containing internationally important species/habitats.

IPPC

Integrated Pollution Prevention Control - IPPC licences aim to prevent or reduce emissions to air, water and land, reduce waste and use energy/resources efficiently. An IPPC licence is a single integrated licence which covers all emissions from the facility and its environmental management.

ISO International Standards Organisation Lx Sound that exceeds the level L for x% of the sampling duration.

Leq Equivalent continuous steady sound level. Effectively an average value.

Lden The day-evening night composite noise indicator adopted by the EU for the purposes of assessing overall annoyance.

l/s Litres per second. Local Ecological Significance

Other areas not classified as being of International, Regional, or National importance.

Long-Term Impact Impact lasting twenty to fifty years.

Made Ground Solid ground formed by filling in an artificial or natural pit with hard rubble such as broken brick, concrete, etc., or with rubbish.

Magnitude (impact) Impact magnitude depends on the degree and extent to which the project changes the environment.

MD Maximum Demand.

Mean Annual Maximum flow per annum for the full dataset presented as a mean value.

Medium-Term Impact Impact lasting seven to twenty years.

Methodology The specific approach or techniques used to analyse impacts or describe environmental features and conditions.

m/s Metres per second. mg/l Milligrams per litre. m3/day Metres cubed per day. m3/hr Metres cubed per hour. mg/m3 Milligrams per metre cubed. mg/kg Milligrams per kilogramme. MIC Maximum Import Capacity

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mg/m2/day Milligrams per metre squared per day.

Mitigation Measures designed to avoid, reduce, remedy or compensate for adverse impacts.

Mitigation Measures The manner by which a proposed development is modified to avoid, reduce or remedy anticipated adverse environmental effects.

Moderate Impact An impact that alters the character of the environment in a manner that is consistent with the existing and emerging trends.

Mycoplasma hyopneumoniae

A species of bacteria known to cause the disease Porcine Enzootic Pneumonia.

N Nitrogen National Ecological Significance

Areas containing nationally important species/habitats.

Natura 2000 site A site protected under the EU Habitats Directive and the EU Birds Directive.

NHA Natural Heritage Area NIAH National Inventory of Architectural Heritage

Negative Impact

A change which reduces the quality of the environment (for example, by lessening species diversity and the reproductive capacity of the ecosystem, by damaging health, property or by causing nuisance).

Neutral Impact A change which does not affect the quality of the environment. NOX Oxides of Nitrogen. Noise Contours Predicted noise level at a given distance. NRA National Roads Authority NTS Non-Technical Summary NTS (drawings) Not to scale OD Ordnance Datum OPW Office of Public Works Organomercurial An organic compound that contains mercury. OS Ordnance Survey

Overburden The soil and other material that lies above a specific geologic feature.

P Phosphorus PPV Peak Particle Velocity

Perched Groundwater

A perched groundwater layer can be found on top of an impermeable layer rather close to the surface (20 to 100 cm). It covers usually a limited area. The top of the perched water layer is called the perched groundwater table.

Permanent Impact Impact lasting over fifty years. Permeability (hydrogeology)

Capacity for transmitting a fluid.

Pharmacopoeia Is a book containing directions for the identification of samples and the preparation of compound medicines, and published by the authority of a government or a medical or pharmaceutical society.

Piling A column of wood or steel or concrete that is driven into the

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ground to provide support for a structure PM10 Particles measuring 10µm or less).

Positive Impact

A change which improves the quality of the environment (for example, by increasing species diversity and the reproductive capacity of the ecosystem, or by removing nuisances or improving amenities).

Potable Water Water suitable or safe for drinking. Profound Impact An impact which obliterates all previous characteristics.

Propagation Model (Noise)

Noise predictions using the strength and size of the noise source(s), screening effects due to local topography and intervening buildings, dispersion of sound energy over distance, and attenuation due to ground and air absorption.

QA Quality Assurance QC Quality Control Receptor Any element in the environment which is subject to impacts.

Recharge The addition of water to the zone of saturation; also, the amount of water added.

Return Period The frequency with which a certain event would be expected to occur on average over a long period of record.

Residual Impact The degree of environmental change that will occur after the proposed mitigation measures have taken effect.

Regional Ecological Significance

Areas containing regionally important species/habitats.

Ringfort Circular fortified settlements that were mostly built during the Iron Age (800 BCE–400 CE), although some may have been built as late as the Early Middle Ages (up until ~1000 CE).

RMP Record of Monuments and Places SAC Special Area of Conservation Sensitivity (impact) The potential of a receptor to be significantly changed. SRI Sound Reduction Index SPA Special Protection Area TA Luft Technical Instructions for Maintaining Air Quality. Temporary Impact Impact lasting for one year or less. Tyvek Gown Disposable paper gowns. WDC Western Development Commission WRBD Western River Basin district

Vaccine A vaccine is a biological preparation that improves immunity to a particular disease.

Visual Robustness Ability of the visual receptors to incorporate change.

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1.0 INTRODUCTION

1.1 The Project

Proposed extension to the Elanco Animal Health Facility, Sligo, Co. Sligo.

1.2 EIA Legislation and Requirements

This Environmental Impact Statement is produced as part of the Environmental Impact Assessment (EIA) process. The EIA process is defined by, and derived from, the EIA Directive (EU Directive 85/337/EEC as amended by Directives 97/11/EC and 2003/35/EC), which was transposed into Irish legislation in 1989 by the European Communities (Environmental Impact Assessment) Regulations, 1989 (S.I. No. 349 of 1989) and the Local Government (Planning and Development Regulations) by S.I. 25 (1990). Later amendments have been transposed into Irish law through a range of Acts and Regulations, including The Planning & Development Act 2000, The European Communities (Environmental Impact Assessment) Regulations, 1989 to 2006, Local Government (Planning and Development) Regulations, 1994 to 2001, and The Planning & Development Regulations 2001-2009.

The proposal is to construct a new extension to the facility for the manufacture of a animal health vaccine at a scale considerably larger than current manufacturing on site. An EIS is required, as the manufacturing of products using bio-synthesis is a scheduled activity under Part 2, Clause 6(a), Schedule 5, S.I. No. 600 of 2001, Planning and Development Regulations 2001. An EIS is a key component of the impact assessment procedure, and the information to be contained in an EIS is listed in Annex III of the Directive (85/337/EEC) and in Article 25 (Second Schedule) of the European Communities (Environmental Impact Assessment) Regulations, 1989. This document is submitted in accordance with the Planning and Development Act 2000 and the Planning and Development Regulations 2001-2009.

1.3 EIA Objectives and Process

This EIS presents the results of the EIA process, which was undertaken to inform the permitting and decision-making process. The objectives of the EIA may be summarised as follows:

• To identify the likely significant environmental impacts associated with the

construction and operation of the proposed extension having regard to the characteristics of the local environment; and

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• To evaluate the magnitude and significance of likely impacts and to propose appropriate measures to mitigate potential adverse impacts.

The process undertaken involves the following steps:

• Collating existing baseline data for the proposed development site and the surrounding area;

• Undertaking environmental surveys to supplement existing baseline data; • Evaluating the proposed construction and operational activities associated

with the proposed extension; • Identifying features of the existing environment likely to be affected by the

development of the proposed extension; • Identification, description and evaluation of the potential environmental

impacts arising from the proposed extension; • Providing feedback into the planning and design of the proposed extension; • Identifying mitigation and enhancement measures; • Description of residual impacts; and • Production of an EIS to support the planning application.

This EIS is a statutory document which presents the results of the EIA process undertaken for the proposed extension to the Elanco facility. It will be provided to Sligo Borough Council as supporting information for the planning application.

1.4 EIS Structure

The format of this EIS is as follows:

Section 1: Introduction Presents background to the proposed extension and provides an overview of the assessment process. Section 2: Environmental Assessment Process Summarises the assessment methodology adopted including details of the scoping process undertaken. Section 3: Consideration of Alternatives Describes the site selection process and the consideration of alternatives in site layout and design. Section 4: Planning and Legislative Framework Describes the broad planning and environmental legislative framework under which the proposed extension will be carried out. Section 5: Project Description Provides a description of the proposed extension in terms of both its construction and operation phases.

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Sections 6-16: Impact Assessment and Mitigation Describes baseline conditions for various environmental aspects and provides an assessment of significant environmental effects taking into account mitigation measures to be implemented. The following topics have been assessed:

• Socio-economic; • Ecology; • Surface Water & Drainage; • Soils, Geology and Hydrogeology; • Noise & Vibration; • Air Quality & Climate; • Landscape and Visual Impact; • Cultural Heritage; • Transportation; • Waste Management; and • Material Assets.

Section 17: Interaction of the Foregoing and Cumulative Effects Section 18: Summary of Mitigation Measures

1.5 Project Team

The EIS was prepared on behalf of Elanco Ltd. by a study team led and coordinated by Jacobs who were responsible for the overall management of the assessment as well as for the production of the EIS document.

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2.0 ENVIRONMENTAL ASSESSMENT PROCESS

2.1 Introduction

The Environmental Impact Assessment (EIA) process detailed within this Environmental Impact Statement (EIS) has been undertaken in accordance with the Planning & Development Regulations 2001-2009. Consideration has also been given to other relevant guidance, including the Guidelines on the Information to be included in Environmental Impact Statements (EPA, 2002) and Advice notes on Current Practice (in the preparation of Environmental Impact Statements) (EPA, 2003).

2.2 Screening The screening assessment has evaluated the need for an EIS for the proposed extension having regard to the Planning and Development Act and Regulations. The conclusion of the assessment is that an EIS is required for the following reasons. The proposal is to construct a new facility for the manufacture of an animal health vaccine at a larger scale than current manufacturing on site. The scale represents approximately a 100% increase in manufacturing capacity. An EIS is required, as the manufacturing of products using bio-synthesis is a scheduled activity under Part 2, Clause 6(a), Schedule 5, S.I. No. 600 of 2001, Planning and Development Regulations 2001. However, having regard to other assessment criteria set out in the Planning Regulations - the location and characteristics of the proposed extension and the characteristics of the potential impacts, the proposed extension will not create significant adverse environmental impacts and therefore the EIS has been scoped accordingly (see section paragraph 2.6 below).

2.3 Aims of the Assessment

The key objectives of the EIA process undertaken for the proposed extension and reported within this EIS have been to:

• Provide a framework for the assessment of environmental impacts within the

context of the proposed extension, including construction and development phasing;

• Follow on from the environmental scoping exercise undertaken (see Section 2.6 below) and subsequent regulatory feedback by defining the issues requiring assessment;

• Outline the methods and assessment criteria employed in undertaking baseline and environmental impact assessments for each separate aspect;

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• Assess the environmental baseline conditions for all disciplines scoped as requiring assessment;

• Assess the impact of the proposed extension on each of the identified baseline conditions;

• Assess the cumulative impacts of the proposed extension on all identified baseline conditions;

• Outline recommendations to mitigate against all significant impacts identified; • Detail residual impacts assuming mitigation will take place as recommended;

and • Provide conclusions to each section and the EIS as a whole and outline

requirements for further studies and assessments where necessary. The requirements for further studies and assessments will include the monitoring and investigation of measures recommended to mitigate predicted construction and operational impacts.

2.4 Outline of EIA Principles

2.4.1 Overview

The environmental effects of the proposed extension will be predicted for each relevant environmental aspect (e.g. ecological resources, noise, traffic and transport, etc). This will involve comparing the existing baseline environmental conditions with the conditions that would prevail if the proposed extension were to proceed. The environmental effects are predicted in relation to their effect on the receiving environment, that is, people, cultural heritage and natural resources. The process of impact prediction involves the application of a number of the following key principles and concepts:

• Significance of environmental effects; • Geographical (or spatial) scope of the EIA; • Temporal scope of the EIA; and • Technical scope of the EIA.

The application of each of these elements to the proposed extension is further explained in the subsections that follow; further definition, specific to particular technical areas, is provided in each of the technical Sections 6 – 16.

2.4.2 Defining the Significance of Environmental Effects Whilst there is no statutory definition of what constitutes a significant effect, progressive environmental legislation and guidance over the past several decades has established limit values, thresholds and intervention criteria for many of the technical areas assessed. For some topics, such as, for example, landscape and visual assessment, practitioners have defined best practice methods and

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assessment criteria, which provide an agreed framework within which professional judgment is exercised. The impact assessment has been prepared having regard to, amonst others, the following documentation:

• ‘Guidelines on the Information to be included in Environmental Impact

Statements’ (EPA, 2002); and • ‘Advice notes on Current Practice (in the preparation of Environmental Impact

Statements)’ (EPA, 2003). Whether derived from quantitative standards or through professional judgment, the significance of an impact is assessed through a combination of two factors:

• the size or magnitude of the impact (e.g. source noise levels or proximity of

the development to a potential receptor); and • the sensitivity or importance of what is being affected by the development

(e.g. a local landuse sensitive to increased noise levels or a rare and/or designated habitat).

Whilst the above two factors (magnitude and sensitivity) are key factors in assessing significance, it is also important to take into account the likelihood of the impact actually taking place and the period of time for which the impact will be experienced.

2.4.3 Mitigation of Predicted Environmental Effects The role of this EIA within the development process has not merely been to identify, assess and report on impacts that are likely to arise. As impacts have been identified, the EIA team has worked closely with the engineering and design team in identifying measures to prevent, reduce and, where practicable, remedy identified significant adverse impacts. The appointment of environmental specialists by Elanco early on in the planning process has ensured that the design proposals have been developed in conjunction with ongoing environmental evaluation and have been progressed with integrated design and layout solutions that avoid or minimise direct impacts to sensitive receptors within, and within the vicinity of, the proposed Sligo site. Detailed recommendations for mitigation measures to be taken in respect of the proposed extension proposals are detailed in each of the technical Sections 6 – 16, and summarised in Section 18.

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2.4.4 Mitigation Measures In order to reduce the magnitude of an impact, and thus reduce the significance of that impact, mitigation measures may be implemented. The following hierarchy is used when determining mitigation measures:

• Prevent – to avoid adverse impacts as far as possible by designing out or using preventative measures during the construction process thus resulting in an environmental effect of negligible significance;

• Reduce – to minimise the magnitude of adverse impacts as far as possible by using preventative measures thus resulting in an environmental effect of minor – negligible significance; and

• Offset – to compensate for environmental effects of major – moderate significance arising from unavoidable impacts that cannot be further reduced in magnitude.

Mitigation measures can be incorporated at three stages of a development:

• During the design stage in order to design out or reduce the magnitude of

predicted impacts; • During construction in order to minimise the magnitude of adverse impacts

arising during the construction process; and • Following commissioning of the new facility in order to minimise the

magnitude of adverse impacts arising during operation.

2.4.5 Geographical Scope of the EIA The EIA covers the physical extent of the proposed extension and defined by the limits of land to be used, the nature of the current environmental conditions and the manner in which impacts are likely to be generated. In addition, the significance of some predicted impacts can extend beyond the immediate site; for example, depending on prevailing wind conditions, dust and other emissions could be experienced at some distance from the proposed development site, whilst the effects on some species that are primarily located off-site, but which use the site for foraging, have been assessed. The geographical extent of the EIA also considers the potential implications of related and un-related development activities such as:

• Developments that may occur as a consequence of the proposed extension (e.g. provision of road or junction improvements);

• Existing activities which will change or cease as a consequence of the proposed extension (e.g. current landuses undertaken on the site); and

• Potential cumulative effects with other proposed (but unrelated) developments.

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The assessment of cumulative impacts will ensure that where a number of developments are proposed within the wider area, each set of effects (which may in themselves be insignificant) are assessed in combination (i.e. cumulatively) to determine whether the total of these effects is in itself significant.

2.4.6 Temporal Scope of the EIA The temporal scope of the EIA relates to the duration or timescale of potential impacts and is broadly concerned with:

• The anticipated duration of the construction and development phases of the

proposed extension. This currently assumes a start date of circa February/March 2011 with the commissioning of the proposed extension in circa mid-2012; and

• On the assumption that these indicative dates are met, the operational phase of the proposed extension will commence in circa end of 2012. In assessing impacts from the proposed extension, consideration has been given to periods beyond the commissioning date in order to take account of those environmental effects that are dependant upon longer-term considerations, such as traffic and socio-economic outcomes. These longer term considerations have also been incorporated into recommendations for the implementation and maintenance of long term mitigation measures.

2.4.7 Technical Scope of the EIA The range of environmental topics in this EIS has been identified through an informal scoping process (see Section 2.6 below), which has provided the main focus for the technical scope of the EIS.

2.5 The EIA Scoping Process

2.5.1 Overview The aim of the scoping process was to identify key issues specific to the project or the receiving environment, which were to be addressed in detail in the EIA process.

The determination of the likely significant impacts was achieved through:

• A review of the facility’s existing Integrated Pollution Prevention & Control

(IPPC) Licence and application documents; • A review of the previous EIS lodged in association with the manufacturing site

provided by For Dodge Laboratories (1999); • A review of existing assessments / reports previously undertaken in relation to

Elanco Ltd. operations and the proposed development site; • Consultation with Elanco Ltd (e.g. EHS Officer, Mr. Paul Monaghan); • Consultation with the specialists with significant knowledge of the

requirements of the bio-synthetic manufacturing industry; and

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• Consultation with stakeholders such as Sligo Borough Council and statutory consultees such as the Environmental Protection Agency (EPA), Inland Fisheries Ireland and National Parks and Wildlife Service (NPWS) (Please refer to Appendix 2 for consultation letters).

2.5.2 EIS Scoping Format Environmental issues with the potential to be significantly impacted by the proposed extension are addressed under the following headings:

• Socio-economic; • Ecology; • Surface Water & Drainage; • Soils, Geology and Hydrogeology; • Noise and Vibration; • Air Quality and Climate; • Landscape and Visual Impact; • Cultural Heritage; • Transportation; • Waste Management; • Material Assets; and • Interaction of the Foregoing and Cumulative Impacts.

2.6 Scoping – Environmental Aspects

The following environmental aspects will be considered in this EIS:

2.6.1 Socio Economic The study area is contained within the existing boundary of the Main Plant and is located within an established industrial area. The proposed extension will result in a maximum of circa 10 - 15No. new permanent staff. The existing facility has not received any environmental complaints from the public over the past 6 years. Based on the preliminary findings, the following will be undertaken to report on the topic of ‘Socio-Economic’ within the EIS:

• A brief assessment of the demographics of the local region, employment and use of public resources;

• A review of the impacts on surrounding commercial areas in the vicinity of the proposed extension will be carried out;

• Consideration will be given to perceived environmental health issues associated with the use of bio pharmaceutical products;

• An assessment of the commercial impacts of both construction and operations into the local economy; and

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• Potential traffic impacts and mitigation measures / plans for the proposed extension and surrounding road network will be outlined in the “Transportation Section”.

2.6.2 Ecology The site is location approximately 0.7km south of the Garavogue River / Sligo Harbour Estuary which is a part of the Cummeen Strand Special Area of Conservation (SAC), Special Protection Area (SPA), and proposed Natural Heritage Area (pNHA). The potential for a subsurface migratory pathway for contaminants via perched groundwater towards the Sligo Harbour Estuary (i.e. the Cummeen Strand SAC) is recognised. Key issues associated with this section will include:

• Hydrogeological link with the SAC/SPA/pNHA. Based on the preliminary findings, the following will be undertaken to report on the topic of ‘Ecology’ within the EIS:

• Desk-based study, supplemented by preliminary site walk-over findings; • Consultation with the appropriate statutory and non-statutory bodies; • Ecological Impact Assessment Screening; and • Appropriate Assessment Screening.

2.6.3 Surface Water Based on the preliminary findings, the following will be undertaken to report on the topic of ‘Surface Water / Drainage’ within the EIS:

• Desk-based study, supplemented by preliminary site walk-over findings; • Consultation with operators and/or agents of the Sligo WWTP with regards to

any increases in emissions from the proposed extension; • Desk-based assessment of flooding risk; • An assessment of the protection measures required from potential fire water

impacts will also be undertaken; and • Protection measures applicable to the detailed design, construction and

operation phases will be outlined.

2.6.4 Soils, Geology and Hydrogeology Key issues associated with this section include:

• Potential subsurface migration of contaminants via perched groundwater to the SAC; and

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• Confirmation of the soil characteristics at the proposed development site. Based on the preliminary findings, the following will be undertaken to report on the topic of ‘Soils, Geology and Hydrogeology’ within the EIS:

• The existing soils, geology and hydrogeology of the proposed development site will be characterised by firstly undertaking a desk-top study utilising the reports previously commissioned for the site and publicly available information from sources such as the Geological Survey of Ireland (GSI);

• An assessment of soils and rock characteristics and vulnerability; • Investigate potential migratory pathways for contaminants (particularly

potential links to the SAC); • An assessment of mitigative and protective measures to ensure no off-site

impacts arising from the proposed extension; • Review known aquifers and water supplies in the region e.g. private or public

water supplies nearby; and • An assessment of the vulnerability of the aquifers and their significance and

mitigative measures to contain them.

2.6.5 Noise & Vibration The key issues associated with this section are:

• Additional fixed plant and equipment associated with the proposed extension, such as chillers, Air Handling Units etc.

A baseline noise survey will be undertaken at the Elanco Ltd site and at the site of the nearest sensitive receptors. Based on the preliminary findings, the following will be undertaken to report on the topic of ‘Noise & Vibration’ within the EIS:

• The results of baseline noise monitoring measurements will be assessed against the emission limits outlined in the existing IPPC Licence;

• An assessment of the additional noise contribution, which will be demonstrated through suitable noise prediction calculations, from the proposed extension at the nearest sensitive receptors. A detailed computer based propagation model with noise contours is not considered necessary for this EIS;

• An assessment of the potential construction noise impacts will be made using information relating to the likely plant and equipment to be used during the worst-case phases of construction; and

• Consideration will be given to the implementation of noise mitigation measures if deemed required, and those measures considered appropriate will be included within the proposed extension layout and design.

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2.6.6 Air Quality and Climate Key issues associated with this section include:

• Potential emissions of new/additional substances to air. It is considered that any additional air emission loading will be limited in scale and minor in nature;

• Limited increase in traffic movements; and • Addition of equipment using ozone depleting substances and/or fluorinated F-

Gases. Baseline measurements for Nitrogen Dioxide at the proposed development site and in the vicinity will be undertaken. Based on the preliminary findings, the following will be undertaken to report on the topic of ‘Air Quality & Climate’ within the EIS:

• Baseline air quality will be assessed for the pollutants relevant to the scheme

and included in EU Directive 2008/50/EC on Ambient Air Quality and Clean Air for Europe;

• A desk study will be used to further establish the baseline from measurements and predictions made in the Sligo area. Any other relevant sources of information will be taken into account (e.g. published data from EIS’s for nearby developments); and

• An assessment of any additional/new emissions to air will be made. However based on the limited scale of the potential emissions, a detailed dispersion model is not considered necessary for the proposed extension.

2.6.7 Landscape and Visual Impact The following will be undertaken to report on the topic of ‘Landscape & Visual Assessment’ within the EIS:

• The visual impact assessment will include an assessment of the visual robustness or vulnerability of the proposed development site including its local and regional significance;

• An assessment of the impact of any proposed additional onsite lighting during construction and operational stages, on the surrounding environs will be undertaken;

• Appropriate measures for mitigation against long term landscape and visual impacts as a result of the proposed extension will also be addressed; and

• Consideration will be given to surrounding boundary treatments.

2.6.8 Cultural Heritage A desk-based assessment will be undertaken using the following sources of information which will be consulted for a study area extending 150m from the proposed development site boundary line:

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• Record of Monuments and Places (RMP); • National Inventory of Architectural Heritage (NIAH); • Topographic Files of the National Museum of Ireland; • Sligo County Development Plan 2005-2011 for information on Architectural

Conservation Areas; • Excavations Bulletin and www.excavations.ie; • Aerial Photographs held by the Geological Survey of Ireland; • Ordnance Survey and pre-Ordnance Survey mapping; and • National Archives of Ireland.

2.6.9 Transportation Proposed construction and operation traffic associated with the proposed extension will not require additional access and at this stage of the assessment, the impact on road users and adjacent receptors is not considered to be significant. The following will be undertaken to inform the traffic assessment:

• The impacts from both construction and operational traffic will be addressed; • Appropriate consideration will be given to the development of any traffic

mitigation measures / plans for the proposed extension and surrounding road network; and

• Key interests along the proposed route to the development site including relevant land owners and business will be considered.

2.6.10 Waste Management

The assessment of the liquid wastes will include the following:

• Characterisation of waste and minimisation where possible; and • All other aspects related to liquid waste will be addressed in ‘Surface Water

and Drainage’ of the EIS. An assessment of the solid waste management shall include the following:

• Potential for re-use of operational solid waste resulting from the proposed extension;

• Re-use and recycling of construction wastes; and • Assessment of waste reduction strategies both in operational and in

construction phases.

2.6.11 Material Assets This section will provide an assessment of the potential impacts of the proposed extension on material assets. The purpose will be to discuss the utility services that are to be provided for the proposed extension, including:

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• Potable Water; • Waste water; and • Electricity Supply.

2.6.12 Interrelationship between Environmental Factors All of the prescribed topics for the study will be discussed separately in the preceding sections of the EIS. The EPA in its Advice Notes on Current Practice in the Preparation of Environmental Impact Statements (EPA 2002) states that this section should draw attention ‘to significant interaction and interdependencies in the existing environment’.

2.7 Conclusions Whilst the general principles adopted in the EIA of the proposed extension are outlined in Sections 2.2 – 2.6 above, further aspect specific information is included in each of the individual technical sections presented in Sections 6 to 17 below. This EIS represents the principal output of the EIA process and will contribute to, and inform, the permitting decision-making process. The mitigation and monitoring measures identified within this document will form part of the ongoing environmental actions to be undertaken as part of the construction and operation of the proposed extension and the scope of these ongoing actions are summarised within Section 18 of this statement.

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3.0 CONSIDERATION OF ALTERNATIVES

3.1 Introduction This Section of the EIS describes the evaluation of the principle alternatives identified during the proposed extension options process and the main reasons for the selection of the preferred extension option.

3.2 Examination of Alternative Options A master planning exercise was conducted to assess the insertion of the proposed extension on the existing Elanco site. The process of master planning is a co-operative effort with all site and corporate stakeholders. Thus the master plan was developed over a 4 week period with the site team. The methodology adopted was as follows:

• A structured process to understand the historic or existing operations; • The development of a model for the proposed extension (Stellamune Plant); • A holistic look at all potential options; • The ranking and rating of the various options to agreed criteria with the

stakeholders; and • Full “buy-in” of the chosen extension option.

The Master Plan consisted of 3 phases of design investigations:

• A site potential maximisation phase; • A new plant synergy layout phase; and • A design optimisation phase.

Each phase was intensively reviewed at stakeholder sessions. The objective of the master plan was to decide how best to integrate the proposed extension into the existing manufacturing site.

3.3 Existing Site Analysis The manufacturing and support activities for Elanco are currently spread over 4 main buildings in the Finisklin Industrial Estate. See Volume 3, Figure 1.2 for location of each of the main facility buildings:

• The manufacturing plant itself is located on a circa two acre site; • St. Colm’s, the packaging and warehouse facility which is currently leased; • The QA/QC laboratory building housed in an Elanco owned IDA incubator

unit; and • A small leased office / admin premises.

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The existing manufacturing facility is placed centrally on its site, making large scale additions slightly more difficult because of the restricted available site area between the buildings facades and the nearby site boundaries (see Volume 3, Figure 1.2). An analysis of the existing site showed that a disproportionate area is dedicated to manufacturing with relatively modest areas dedicated to logistics, offices or utilities. This is the mark of an intensively and efficiently used manufacturing facility. (See Figure 3.1 below) However one of the consequences of this is that most of the production logistics are at the St. Colm’s facility and many materials are double and triple handled across the IDA Estate.

Figure 3.1 Existing Site Use

3.3.1 Opportunities and Constraints The organisation of the site can be simply described in an opportunities and constraints diagram as shown in Figure 3.2 below.

Existing Site Plan

ADMINISTRATION

PRODUCTION & SUPPORT AREAS

WAREHOUSE

PLANT ROOMS

NEW PRODUCTION

REFURBISHED PRODUCTION

AREAS

NEW WAREHOUSE

NEW PLANT ROOM

N

SITE ZONED: BITPBUSINESS, INDUSTRY & TECHNOLOGY PARK

TANKSOVERFLOWCAR PARKING

SERVICEYARD

STAFFPARKING

EXPANSION SITE

MAINSITE

ENTRANCE

SITEENTRANCE

Greenfield Area

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The key lesson of this diagram is the “natural” placing of utilities, manufacturing and offices to respect the existing pattern. This maximises the leverage of any assets in the existing facility.

Figure 3.2 Site Analysis Opportunities & Constraints

Another development of this is shown on Figure 3.3 below. This figure shows that there is an easy expansion capability of circa 100% of all activities on site. The proposed extension (Stellamune suite) in contrast, needs only a 20 to 25% increase of floor area. From this it is possible to place the proposed extension in a number of locations on the existing site.

SITE ANALYSIS

OPPORTUNITIES &

CONSTRAINTS

SITE FALLS by 2m aprox

SW PREVAILING WINDSEXISTING

TREES

NN

EXPANSION SITE

EXISTING TREESRETAIN IF POSSIBLE

EXISTING TREES

PRIVATEPLANT & DOCKS

MANUFACTURING CORE

PUBLICOFFICES &PARKING

SITE SLOPES

SITEENTRANCE

MAINSITE

ENTRANCE

FIN

ISK

ILLI

N R

OA

D

TO R292(STRANDHILL ROAD)

TO QUAYS,N4 &SLIGO TOWN

NEIGHBOURING PLANT

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Figure 3.3 Existing Site Building Extension options

3.4 Masterplanning

3.4.1 Phase 1 In Phase I master planning, 8 site locations were investigated for the proposed extension. These were grouped according to their relationship to the existing facility. (See Figure 3.4, Option A, hereunder as a typical example).

EXISTING SITE Building Expansion Options

N

ADMINISTRATION


WAREHOUSE

PLANT ROOMS



UTILITY EXPANSION

OFFICE EXPANSION

OFFICE EXPANSION

WAREHOUSEEXPANSION

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Figure 3.4 Option A: Integrated Buildings

The lessons of these first options may be summarised as follows:

1. “A” Option (site integrated options) are best for cost and leveraging existing

facility; 2. “B” Option (site isolated options) are too costly, requiring parallel support

structures, (services, undergrounds, boilers, gowning etc); and 3. “C” Option best for non disruption of operations and potentially less costly

construction.

The conclusion was to develop “A” and “C” options.

3.4.2 Phase 2 The Phase 2 master planning studies considered 5 further options, 3 rear site options, 1 yard area option and one front of site option. The purpose of these options was to identify which option offered the most synergies with the circulation and manufacturing patterns of the existing facility. The additional 5 options are demonstrated together in Figure 3.5 below.

Option A: Integrated Buildings(Existing Manufacturing Area)

N

ADMINISTRATION


WAREHOUSE

PLANT ROOMS

NEW PRODUCTION

REFURBISHED PRODUCTION

AREAS

NEW WAREHOUSE

NEW PLANT ROOM

SITE BOUNDARY

RETAIN EXISTING TREES

PROPOSED ADDITIONAL PARKING

FUTURE BUILDINGEXPANSION

MAIN SITE ENTRANCE

A

B

C

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Figure 3.5 Proposed Extension site options

3.4.3 Phase II Ranking and Rating

These 5 options were assessed by the stakeholder team against ranking criteria such as cost, G.M.P., production disruption etc, so as to bring forward the preferred solutions. Two solutions were judged to be the most appropriate design solution, Option 1 and Option 3.

3.4.4 Phase III Design Optimisation

The design of optimal solution was based on the Option 3 as it offered the best integration with the existing facilities.

3.5 Proposed Extension Description The proposed extension, which will be a phased development, consists of 4 interrelated operational facilities. See Volume 3, Figure 1.3 for a detailed layout of the proposed extension.

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1. The Stellamune “containment level 2 suite” facility consisting of fermentation inactivation, in process laboratory and inoculation laboratory. This suite has its own entrance to minimise cross contamination, its own waste suite and a buffered interface with the existing facility;

2. The “Fill Finish” suite consisting of a formulation suite directly adjacent to the Filling and Capping machine;

3. The “Ancillary Suite” consists of re-using existing facilities for both media and oil dispensing and the staging and logistics associated with the facility, particularly with tray-off; and

4. The “technical support suite” consisting of 2 levels. o The upper mezzanine level holds all the air handling equipment and

access to the wack on ceiling; and o The lower level holds all the cip skids and pumping/chilling skids

associated with the process equipment.

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4.0 PLANNING AND LEGISLATIVE FRAMEWORK

4.1 Introduction

This section of the EIS sets out the planning and development context relating to the proposed extension on the proposed development site. This section reviews the national, regional and local planning policy relevant to the proposed extension. The proposed development site is located in Finisklin Industrial Estate, Sligo, Co. Sligo. The following planning documents are relevant to the assessment of the planning application for the proposed extension:

• National Development Plan (2007 - 2013); • National Spatial Strategy (2002 – 2020); • Regional Planning Guidelines for the Border Region (2004-2024); • Sligo County Development Plan (2005-2011); and • Sligo and Environs Development Plan (2010-2016).

The proposed development site does not fall under one of the Local Area Plans adopted for County Sligo’s Key Support Towns and other settlements.

4.2 Site Location & Context The study area for this assessment consists of developed land within the boundary of the previous Fort Dodge Laboratories Ireland (FDLI) Main Plant now Elanco Animal Health. The extents of the Main Plant consist of the production building itself, a front and rear car park, an access road, a concrete yard area, dedicated waste management areas, a sprinkler holding tank, and small areas of landscaped grounds. The proposed development site is located within the Industrial Development Authority of Ireland (the IDA) Finisklin Industrial Estate, Sligo, and lies approximately 1 km north west of Sligo city centre. The industrial estate consists of a complex of low density two storey buildings and covers an area of approximately 24 hectares (60 acres) within which there are a range of low/high tech industries. Established at its current location in 1991 and operational in 1992, Elanco produces and tests a range of veterinary vaccines (biologicals) which include products to protect the health of cats, dogs, horses and cattle. These products are presented as injectable sterile liquids, both in vials or syringes, and in freeze-dried form. Production facilities in the Main Plant consist of multiple clean room/contained sterile process areas, with a central support area for washing, and dispensing of material.

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4.3 Planning History The manufacturing of vaccines has a 20 year history at Finisklin. The initial planning permission dates from 26/11/1990 (Ref. No. P.D. 3336) requesting the change of use of advance factory No. 3, Finisklin for the manufacture of veterinary medicines. An EIS was attached to this permission and this document focussed on four topics; effluent, air emissions, waste disposal and noise. There have been 6 other smaller planning applications lodged relating to this site between 1998 and 2006. These small planning applications range from the erection of a maintenance stairs and substation at the main factory to the erection of a single storey extension to provide a new entrance foyer & conference room. These projects did not require an EIA to be undertaken.

4.4 National Planning Context1

4.4.1 The National Development Plan (2007-2013) The National Development Plan (NDP) has four basic strategic objectives:

• To continue sustainable national economic and employment growth; • To strengthen and improve Ireland’s international competitiveness; • To foster balanced regional development; and • To promote social inclusion.

The NDP sets out an investment programme which prioritises certain projects under the five strategic headings of:

• Economic Infrastructure; • Enterprise, Science and Innovation; • Human Capital; • Social Infrastructure; and • Social Inclusion.

It is a key objective of the Plan to maintain competitiveness and to continue to attract foreign direct investment into Ireland. It is also an objective of the Plan to integrate regional development in accordance with the National Spatial Strategy. The proposed extension is in line with the investment priorities outlined in the NDP and will help ensure that the returns on these investments are maximised. The proposed extension will provide direct employment for approximately 10 - 15 people. There will be additional contract employees from time to time. The profile of employees will range from highly qualified employees to general operatives. Total capital investment on the Elanco Ltd. site is estimated to be circa €20 million.

1 Only the national planning and development policy considered particularly relevant and appropriate to this proposed extension has been considered in this Section.

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The proposed extension is consistent with the aims of the NDP as it will provide contribute to local and national economic and employment growth. This investment will strengthen Elanco Animal Health position in the marketplace, thereby complying with the investment priorities of the NDP.

4.4.2 The National Spatial Strategy (2002) The National Spatial Strategy (NSS) (2002) for Ireland is a twenty-year planning framework designed to achieve a better balance of social, economic, physical development and population growth between regions. The National Development Plan (2000-2006) identified Dublin, Cork, Limerick/Shannon, Galway and Waterford as existing gateways, the NSS designated four new national level gateways - the towns of Dundalk and Sligo and the linked gateways of Letterkenny/(Derry) and the Midland towns of Athlone/Tullamore/Mullingar. The NSS acknowledges that the economic performance of these gateways is of great importance to the economic well being of the entire country. Therefore, the strategy supports the continued growth of Sligo and acknowledges the importance of towns such as Sligo to attract mobile investment into the north western region. Section three of the NSS sets out the future spatial structure of the country. The NSS aims to strengthen the role and contribution of towns such as Sligo to drive development through enhanced accessibility and capacity for development. The NSS recognises that in, in order to achieve this, a planning, land use and transportation framework is required. This will allow local authorities, business and community interests to focus and agree on how Sligo’s ‘substantial physical capacity for development’ should be achieved. The NSS encourages enterprise development on lands that are aligned with the spatial structure outlined in Section 3 of the strategy. The lands should provide a high quality setting and location, easy access to key infrastructure such as transport, energy, water services and communications and be well integrated with the spatial structure of adjoining urban areas and their educational facilities. The NSS calls on public policies which recognise the locational requirements of enterprise in order to attract investment and support economic development. The development of the proposed extension for industrial development is in full alignment line with the NSS, the site located is within easy access of the necessary supporting infrastructure.

4.5 Regional Planning Context

4.5.1 Regional Planning Guidelines for the Border Region (2004-2024) The Border Region includes the counties of Donegal, Sligo, Leitrim, Cavan, Monaghan and Louth. Therefore the policies and objectives of these Guidelines are

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relevant to this assessment. The strategic goals for the region include the implementation of the National Spatial Strategy through promoting the development of the new Gateways (Sligo being one of these Gateways) and identifying and prioritising investment in economic, social and physical infrastructure in these Gateways. This is particularly crucial for Sligo with its strategic location in the North West. According to this strategy, Sligo is considered to be capable of providing capacity to develop substantially. The proposed extension will help achieve this objective by demonstrating that Sligo is a highly attractive location for international inward investment, building on the skillsets of the existing Elanco workforce.

4.6 Local Planning Context

4.6.1 Sligo County Development Plan (2005-2011) The future development of the proposed extension will be subject to the provisions of the Sligo County Development Plan (2005-2011). Sligo acts as an important manufacturing and distribution centre in the North-West region of the country, in recent years developing as a major industrial, commercial and residential centre. The County has experienced population growth in the past decade with the largest percentage increase in Sligo Borough, leading to significant growth within some electoral divisions adjacent to or within commuting distance to Sligo Borough (e.g. Knockaree which includes the satellite village of Strandhill).

4.6.2 Strategic Context The Sligo County Development Plan (2005-2011) addresses the National Spatial Strategy’s call for balanced development outside of the Gateways. Sligo City itself is dealt with under a separate Plan; the Sligo and Environs Development Plan 2004-2010.

4.6.3 Economic Strategy The Development Plan sets out a number of policies with regard to economic development which are relevant to the proposed extension. These include the following:

5.4.1B “Promote new industrial developments in other centres with existing infrastructural facilities, services and good communications, or where these can be provided at a reasonable cost. 5.4.1F Promote the integration of employment with other land uses and the transportation network and ensure, in particular, that employment-intensive uses are located in proximity to existing and planned strategic routes, where public transport is most viable.

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5.4.1G Acquire sites for industry and enterprise, subject to the availability of funds.” The proposed extension will create a new inward investment into Sligo, with an estimated total capital investment of circa €20 million. It will provide approximately 10 - 15 jobs and will lead to economic spin off benefits for the local area. The creation of direct and indirect employment opportunities at this location will have a positive impact on residents in Sligo, demonstrating that the city is capable of attracting and retaining high quality, internationally mobile investment. The investment in the strategic infrastructure capacity by Sligo County Council at this location will contribute towards achieving significant returns through employment creation.

4.6.4 Sligo and Environs Development Plan (2004-2010) Sligo and Environs Development Plan (2004-2010) covers the Sligo Borough area and extends beyond it to include lands outside this boundary. This plan provides the framework to promote the development of Sligo as a Gateway City. The Plan acknowledges that in order to develop as a Gateway City, it needs to achieve the necessary critical mass to become a ‘Growth driver’ and the ‘City of the Northwest’ with the full range of services, functions and necessary infrastructure for a Gateway City. The IDA promotes Sligo as a Gateway City, a city that serves the western region to which it targets investment. According to this plan “The Local Authority recognises the strategic regional importance of the Finisklin site. …the site is appropriate for future expansion for industrial activity due to the established use in the area and the current and proposed access improvements such as the proposed Inner Relief Road, the proposed Western By-Pass and upgrading of the First Sea Road.” The proposed extension is consistent with the policies of the Sligo and Environs Development Plan (2004-2010) as follows:

• Facilitate and encourage the development of Sligo as a ‘Gateway City’ and economic growth driver for the northwest;

• Encourage the integration of employment locations with other land uses and the transportation network and in particular, ensure that the location of employment intensive land uses are located in proximity to existing and planned strategic routes, where public transport is most viable;

• Where industrial sites are developed adjacent to residential areas ensure there is adequate screening in the form of tree planting and landscaping;

• Liaise with the IDA, Enterprise Ireland and other relevant bodies, to attract international and indigenous industry, enterprise and employment to the city;and

• Facilitate the provision of infrastructure corridors as a means of attracting investment and employment in Sligo.

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4.6.5 Zoning The proposed extension is zoned for BITP (Business, Industry & Technology Park) development in the Plan (see figure 4.1 below). The objective of this zoning is to ‘promote the development of office-based businesses, technology companies and industrial units in dedicated business-industrial parks at Finisklin, Oakfield, Rathbraghan/Ballytivnan and Doonally.’ The proposed extension is in line with the zoning objectives of the Sligo County Development Plan (2005-2011).

Figure 4.1 Extract from Sligo and Environs Development Plan demonstrating the proposed development site is zoned for BITP (Business, Industry & Technology Park) development

4.7 Conclusions This section of the EIS has reviewed the proposed extension in the context of relevant national, regional and local planning policy. The proposed development site is located within the IDA Finisklin Industrial Estate, Sligo, and lies approximately 1 km north west of Sligo City centre. It is national and regional planning policy to promote the competitiveness of new ‘Gateway’ cities by retaining and attracting mobile foreign direct investment into these designated growth centres. The proposed extension will create direct and indirect economic benefits for the economy. The proposed extension will provide direct employment for approximately 10 - 15 people, with total capital investment estimated to be circa €20 million. The proposed extension is in line with the zoning objectives of Sligo and Environs Development Plan (2004-2010) as the proposed development site is zoned for

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BITP (Business, Industry & Technology Park) development. It is also consistent with the economic, employment and economic enterprise policies of the Sligo and Environs Development Plan (2004-2010). The proposed extension will help Sligo County Council achieve their strategic goal for economic development by attracting significant direct investment and improving access to employment opportunities in the area.

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5.0 PROJECT DESCRIPTION

5.1 Site Location, History & Context The proposed development site is located in the Finisklin Industrial Estate which is approximately 1km north west of Sligo City centre and immediately to the west of the N4 Sligo Inner Relief Road. See Figures 1.2 – 1.3 for the site location plan and the local area location plan. The Finisklin industrial estate covers an area of 24 hectares. The estate has a number of low/high tech industries including medical diagnostics, light engineering workshops, food processing and service businesses. The estate is located within the administrative area defined as Outer City and according to the Sligo and Environs Development Plan 2010 – 2016 is zoned as “BITP” which is defined as Business, Industry and Technology Park. This zoning has the specific objective of “promoting of office based businesses, technology companies and industrial units in dedicated business industrial parks of Finisklin, Oakfield, Rathbraghan/ Ballytirnan and Doonally”. The proposed extension site was formally operated by Fort Dodge Laboratories Ireland. This plant was constructed in 1991 and began production of in 1992 and produced a range veterinary vaccines (biologicals). Elanco Animal Health (EAH), the animal health division of Eli Lilly & Co Limited acquired AHP Manufacturing (trading as) Fort Dodge Laboratories Ireland Limited from Pfizer Inc in April 2010. The Elanco site boundaries occupy approx. 4 hectares. The Elanco Facility consists of the following buildings:

• Main Manufacturing/Production Facility located south of Finisklin Road; • Quality control Laboratory at Finisklin House south of the main plant, where

evaluation of raw material, in-process/environmental sample and final product is conducted;

• A Labeling/Packaging Warehousing and administration building at St. Colm’s houses, located north east of the main plant; and

• The leased administration building located across from the Main Building, north of Finisklin Road.

The site boundary includes a greenfield plot lying immediately south of the main manufacturing building. Figure 1.2 in Volume 3 shows the Elanco site boundaries within the Finisklin industrial Estate. Elanco currently operate under the Environmental Protection Agency (EPA) Integrated Pollution Prevention Licence (IPPC) No. P0090-01. This licence was transferred from Fort Dodge Laboratories to Elanco in May 2010. The main production facility and the proposed extension are bounded to the north and west by the Finisklin Road and Abbot Pharmaceutical Ireland, to the south by

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an engineering toolmaker and to the east by a disused engineering manufacturing facility.

Other surrounding land uses in the area include Rathedmond Estate, a relatively large residential estate located south east of the proposed extension and the Ursuline College a third level institution, located to the east of the proposed extension. To the north and east of Finisklin industrial estate lies Sligo Bay and estuary a designated ecological site. See Section 7 for more detail on designated sites.

5.2 Project Background Elanco is proposing to transfer the manufacture of certain vaccines from Pfizer Animal Health, Lincoln, Nebraska and secondary manufacturing of some finished products from Pfizer Animal Health, Louvain la Neuve, Belgium, to their manufacturing site in Sligo. The scope of the proposed extension is to provide additional primary and secondary vaccine manufacturing facilities for the Elanco Stellamune Project that are in compliance with international Good Manufacturing Practice (GMP) regulations, while maintaining production of existing products at the Sligo site. The Sligo site makes several products concurrently. The proposed extension (Stellamune facility) will be adjacent to an existing production building and will share some of the functions of the existing facilities including, gowning rooms, warehousing, dispensary, media preparation, wash and sterilization and some utilities. The new facility will be used to make Stellamune (a vaccine product) and later other sterile dosage forms according to European regulations and will be designed to operate according to international regulations including FDA requirements. The new facility is designed as a multi purpose, multi-product facility for Stellamune animal vaccines using similar processes, in keeping with the rest of the Elanco Facility.

5.2.1 Production Products The Stellamune product is made by the fermentation of Mycoplasma hyopneumoniae, and is a whole cell, natural inactivated vaccine for pigs. The antigen descriptor is Mycoplasma hyopneumoniae Bacterin. The dosage forms are sterile liquid in plastic vials.

Markets At present the market for Stellamune that is to be manufactured in Sligo is Europe. However the facility will be designed and operated according to international GMP regulations so that markets worldwide can be supplied in the future.

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5.3 Construction Phase Overview The construction period is estimated to be 12 - 15 months. The key construction activities will be:

• Site preparation works; • Excavation; • Construction of foundations; • Erection of structures; • Cladding of buildings; • Electrical and mechanical fit out; and • Commissioning, validation and start up.

5.3.1 Employment During the 12 - 15 month construction period, it is estimated that construction employment numbers will increase gradually over the first few months, peaking at approximately 40 – 50 people including management and supervision staff and gradually reducing as construction is completed.

5.3.2 Working Hours Construction working hours in general will be restricted to 07:00 to 19:00 Monday to Friday and 07:00 to 16:00 on Saturday. Requirements for working outside these hours will require prior notification to Sligo Borough Council and will be kept to a minimum to avoid disturbance to the surrounding environs.

5.3.3 Environmental Control - Construction Phase Environmental Management Environmental impacts and mitigation required during construction are detailed within the individual sections of the EIS. Overall, the contractor will be required to submit Construction Environmental Management Plan (CEMP) with detailed method statements at each phase of the development to the Client/Sligo Borough Council. The CEMP shall be in accordance with the following:

• EPA Advice Notes on Current Practice (EPA, 2003); • The National Roads Authority (NRA) series of Environmental Assessment

and Construction Guidelines; and • Relevant CIRIA Best Practice.

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5.4 Operational Phase Overview

5.4.1 Proposed extension The proposed extension consists of 4 interrelated operational facilities as identified below. See Volume 3, Figure 1.3 for details on the proposed extension layout.

1. The Stellamune “containment level 2 suite” facility consisting of fermentation

inactivation, in-process laboratory and inoculation laboratory. This suite has its own entrance to minimise cross contamination, its own waste suite and a buffered interface with the existing facility;

2. The “Fill Finish” suite consisting of a formulation suite directly adjacent to the Filling and Capping machine;

3. The “Ancillary Suite” consists of re-using existing facilities for both media and oil dispensing and the staging and logistics associated with the facility, particularly with tray-off; and

4. The “technical support suite” consisting of 2 levels. o The upper mezzanine level holding all the air handling equipment and

access to the wack on ceiling. o The lower level holds all the cip skids and pumping/chilling skids

associated with the process equipment.

5.4.2 Production Products The product that is the focus of this project is Stellamune. It is a sterile vaccine product made by the fermentation of Mycoplasma hyopneumoniae, and is a whole cell, inactivated vaccine for pigs. The antigen descriptor is Mycoplasma hyopneumoniae Bacterin. The dosage forms are sterile liquid in plastic vials.

Markets At present the market for Stellamune that is to be manufactured in Sligo is Europe. However the facility will be designed and operated according to international GMP regulations so that markets worldwide can be supplied in the future.

5.4.3 Materials Management Materials for the new facility will be managed from an existing GMP-compliant warehouse on the Sligo site. The existing dispensary will be upgraded with the appropriate air locks for materials and for personnel.

5.4.4 Process Technology

The main steps for Stellamune vaccine product manufacture are:

1. Dispensing starting materials; 2. Media Preparation; 3. Upstream solution preparation;

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4. Inoculum preparation and transfer; 5. Bacterial seed growth in a series of sealed fermenters; 6. Inactivation in 1,000l inactivation vessel; and 7. Bulk filling of the vaccine product into bottles or bags.

Media Preparation The existing media preparation room will be used. This is largely the preparation of growth media, sugars etc, to encourage product growth in the fermenters.

Inoculum Preparation An isolator that has been sterilized will be used in a dedicated room to thaw the vial of frozen bacterial seed and to inoculate the required number of seed flasks. These seed flasks are incubated on a rotary shaker at 37ºC ± 2ºC. The seed culture is used to inoculate additional shake flasks in the same isolator and these are also incubated for 48 hours at 37ºC ± 2ºC. Following incubation, the seed culture is transferred to a stainless steel seed transfer vessel or canister which is taken to the fermenter room and is steamed on to the first seed fermenter before it is inoculated. Samples are taken and the isolator is cleaned and sterilized.

Fermentation As the process is fully sealed, closed systems will be used. This ensures that the process is safe and protected. Initially a series of two small fermenters will be used, one with a working volume of circa 10L and the other 100l. A closed system will be used to transfer the contents of the seed/inoculum canister to inoculate the first fermenter. The culture will then be transferred to the second fermenter in a closed transfer pipe and a 1,000l production fermenter will finally produce the product. The fermenters are automated; they are cleaned-in-place and sterilized automatically. All contaminated waste material will be autoclaved prior to being taken out of the facility or inactivated within the vessel in the room. This is for both safety and GMP purposes. Any infectious samples will be contained when they are transported to the QC laboratory. Moreover there is a dedicated in-process control laboratory within the controlled production area.

Inactivation At the end of the cell culture phase, a sterile inactivant will be added to the contents of the production fermenter and mixed for at least one hour, and the entire contents will then be transferred to a pre-sterilized empty 1000L Inactivation vessel. The vessel is agitated, temperature and pH controlled, and inactivation continues to take place for circa. 24 hours. Following the inactivation time, the contents are neutralised and the vessel is incubated for a further 24 hours. The inactivation and

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neutralization kinetics are validated. Inactivation at the scale of operation will be fully qualified. The inactivation and neutralization kinetics are validated. Inactivation at the scale of operation will be fully qualified. Bulk Drug Substance Filling Product Bulk filling of sterile product will be performed in the fermenter room using closed systems. The pipelines are pre-sterilized and the inactivated product is cooled in a stainless steel vessel and dispensed into sterile bags or vessels. These are removed from the area and stored at 2 to 8 ºC.

5.4.5 Definition of Closed Systems for Good Manufacturing Compliance and for Safety Closed systems are used for all production processes in this facility. The term generally means that the system in operation is completely separated from the surrounding environment, and that this separation is validated and monitored. Some typical attributes of a closed system are:

• The system is subjected to clean in place (and also steam in place where

appropriate) before use after it is opened for maintenance; • Transfers are made using proven proprietary aseptic connectors; • Agitators on vessels and process equipment have double mechanical seals or

magnetic drives to ensure containment; • The system is leak tight and is leak tested; • Closed sampling is performed; and • Containment is monitored and breaches are alarmed.

5.4.6 Cleaning Processes An essential component of any closed biopharmaceutical process is it’s integrated cleaning processes. Cleaning is an integral part of the process and cleaning strategies and methods will be transferred and if necessary further developed as part of process development. The facility, equipment and processes will not only be designed to be cleaned, but also designed so that cleaning validation can take place.

Cleaning-in-Place (CIP) The design of Clean-in-Place (CIP) systems where cleaning fluids are re-circulating will be such that there is no possibility of cross contamination between products; the CIP systems will clean themselves.

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5.4.7 Fill Finish Operations Process Technology The main steps for the filling and packaging manufacture are:

• Unpacking and loading of pre-sterilized plastic vials (or bottles); • Sterilization of stoppers and caps; • Sterilization of vessels and filling equipment; • Formulation and Homogenization; • Filling final product into sterile vials; • Capping; • Inspection and labelling; and • Secondary packaging.

The design or the filling operations will follow both the current EU Annex 1 for the manufacture of sterile dosage forms and the requirements of the FDA aseptic processing guide.

Buffer Preparation The solutions used to make buffers used in formulation are sampled for QC and are weighed in the existing dispensary. The buffer solutions are made in a dedicated formulation room. The dissolution process will be qualified. The buffer vessels will be cleaned-in-place and sterilized with clean steam.

Formulation A dedicated Production Suite will be used for formulation. The formulation vessels will be cleaned-in-place and sterilized with clean steam, or cleaned out of place, depending on size.

Homogenization A homogenization process is used to fully blend the mixture. The final formulation vessel, a 1500L vessel, is used on a recirculation basis to homogenize the final formulation.

Filling and Capping Filling will be in a dedicated system with sterile quality clean air. Stoppering will be checked automatically. The filling suite will have dedicated filling machine parts for Stellamune and other products to avoid product mixing. The facility will be designed so that capping is integrated with the filling machine and is performed in a sterile environment. Sterilizing Autoclave An autoclave will be used for the sterilization of equipment, stoppers and caps that opens directly into the filling suite so as to remove any potential for contaminents into the product.

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5.4.8 Quality Control Laboratory

The scope of the project involves an increase in the number of tests that will be performed in existing QC Laboratories and a small extension is planned for this purpose in an adjacent building.

5.4.9 Product Contact Utilities There are sterile utilities within the plant that are used for making product solutions or cleaning of closed systems. These utilities are usually dedicated to a production suite.

Clean Steam Clean steam will conform at the point of use to the Elanco Animal Health standard that is based on the EU, US and Japanese pharmacopoeia. Clean steam will be used for sterilization of vessels and pipes and in sterilizing autoclaves. Clean steam is distributed at high pressure. There is consequently no possibility of cross-contamination via the clean steam system.

WFI Distribution Water for injection (WFI) is generated on site, and distributed. A separate WFI tank and loop is recommended for this new Fill/Finish Suite and bulk production. The EU regulation states that “Water for injection should be produced, stored and distributed in a manner that prevents microbial growth, for example by constant circulation at a temperature above 70°C”. (EU-GMP, Annex 1). The need for loops operated at ambient temperature will be carefully considered, as they impose a risk. Where they are unavoidable, they will be periodically sanitized at 80°C. Distribution valves should be interlocked to prevent the loop velocity falling below the critical value.

Process Compressed Air The quality of air, product contact, at the points of use will comply with international pharmaceutical specifications. An oil-free compressor will be installed as part of the project. There is no possibility of cross-contamination via the process air loop as the air is distributed at high pressure. Drains The drainage systems from the new production facility will be segregated and designed so that there is no possibility of back-contamination via the drains.

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5.4.10 Layout The layout for the facility is in compliance with current GMP. This ensures that the highest standards are applied to every facet of the proposed extension.

5.4.11 Biosafety Introduction The following paragraphs summarise the design features of the proposed extension and also the processes and procedures that will be used to prevent the unplanned release of the viable process microorganism into the environment. The design will be subject to a detailed risk assessment before operations begin. Process Microorganism for Vaccine Manufacture Enzootic pneumonia (EP) is caused by Mycoplasma hyopneumoniae. It is widespread in pig populations and endemic in most herds throughout the world. As an infection in a well-housed and well-managed pig farm it is relatively unimportant and has only a mild effect on the pig. However if there are other infections present the pneumonia can become more complex with serious effects on the pig.). Like most other members of the order Mycoplasmatales, Mycoplasma hyopneumoniae is infective for a single host species. There is evidence of airborne transmission of the bacteria within a herd, but it is slower than with direct contact between pigs. The bacteria spread a short distance from infected pigs to other pigs by coughing. However, mycoplasma does not survive well outside the pig. Transmission from farm to farm is considered most likely through the introduction of infected pigs, but infection that is airborne, by people and by infected objects is reported. A recent assessment of the transmission of Mycoplasma hyopneumoniae by personnel showed that there was no contamination from an infected herd to other herds. However personnel showered and changed clothing when leaving the infected farm. Manufacturing Process and Containment Measures The vaccine manufacturing process involves the culture of Mycoplasma hyopneumoniae in a closed 1,000 litre stainless steel fermentor and then inactivating the whole cells so that they are innocuous, but still retain the physical surface properties that will enable them to create an immune response when injected into a pig. The inactivated whole cells comprise the sterile antigen. The culture must be separated from the environment during growth or it will become contaminated and unusable. The measures used to achieve this separation also ensure that the microorganism does not escape from the closed process equipment. The antigen is stored within the production suite until a test result indicates that the inactivation process has been successful.

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In summary, the process will produce a sterile bulk antigen, containing whole cells, which cannot be sterilised by filtration. It is therefore essential that the process is operated in an aseptic and axenic manner to prevent adventitious contamination from environmental organisms or process additions. This requirement also means that the environment within the facility will be free of the organism and its release from the facility very unlikely. However, the rooms in the suite where the cultures are grown are at a negative pressure to surrounding airlocks and the air leaving these areas is filtered through high efficiency particulate air (HEPA) filters. These will contain the organism within the building in the unlikely event of a spillage from the closed system that remains on the floor before it is disinfected. Waste that is potentially infected is autoclaved out of the antigen production suite and solid waste is bagged for disposal to landfill. Fire water will be collected from the suite and decontaminated chemically before being neutralised. The equipment and suite have been designed and will be commissioned and qualified to meet or exceed the requirements of Containment Level 2 (CL2) as defined in Draft Safety, Health and Welfare at Work (Biological Agents) Regulations 2010 and the current EC Directive and SI No. 248/1998). Any other microorganism species that requires this degree of separation and containment can also be used in the suite in the future. The steps for Stellamune antigen manufacture that involve the handling bacteria are as follows:

• Inoculum preparation and transfer; • Bacterial seed scale-up in intermediate stage fermentors and growth up to

1,000 litre in a production fermentor; • Inactivation and neutralisation in a 1,000 litre inactivation vessel; and • There then follows decontamination of the equipment so that any remaining

bacteria are removed before the next batch is made. These steps are described in more detail below.

Inoculum Preparation and Transfer A vial of frozen cells will be taken from a freezer in the inoculum preparation room located in the CL2 suite and transferred into an isolator that has been pre-sterilized with vapour phase hydrogen peroxide (VHP). The vial of frozen bacterial seed will be thawed and the vial opened in the isolator and used to inoculate the required number of shake flasks. These shake flasks will be incubated within the isolator. Following incubation, the seed culture will be transferred in the isolator from the flasks into a sterile stainless steel inoculum transfer vessel that will be removed from the isolator and taken to the fermentation room. Here it will be connected to the first seed fermentor using a steam-on procedure. When the pipes are cool, the seed will be transferred and the fermentor is inoculated. The transfer will be thus carried out in a closed manner. Samples are taken and the isolator will be cleaned and sterilized.

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Demonstration of isolator integrity is paramount to ensure that the closed process is being maintained. This must be demonstrated through validation and in-process checks and controls, such as leak testing, glove checks, concurrent integrity testing, etc. Access to the isolator will be via a suitable cascade, e.g. two pass through ports. Growth in Fermentors Closed systems will be used, according to a project-specific definition of a closed system. Samples will be taken in a closed manner. The integrity of the fermentation train air filters will be verified after sterilisation and after use to show that the filters have been effective for the removal of bacteria. All additions, samples and transfer from the fermentation train must occur as a closed process. The fermentors will be pre-sterilized and then medium is heat sterilized in the fermentor as well as being filter sterilised into the fermentor, Pre-sterilized fluids will be also added such as anti-foam, depending on the stage of the fermentation. A series of two seed fermentors will be used, one with a working volume of 10 litres and the other 100 litres. A closed system will be used to transfer the contents of the inoculum vessel to inoculate the first seed fermentor as described above. Once sufficiently grown, the culture in the first fermentor will be transferred to the second seed fermentor in a closed transfer pipe and again when sufficiently grown the culture is transferred to the 1,000 litre production fermentor that will produce the product. The fermentors will be automated; they are cleaned-in-place and sterilized automatically. Inactivation to make Stellamune Antigen At the end of the cell growth phase, sterile inactivant will be added to the contents of the production fermentor and mixed for at least one hour, and the entire contents will be then be transferred to a pre-sterilized empty 1,000l inactivation vessel. Sampling for in-process testing must occur prior to inactivant addition. The vessel will be agitated and temperature controlled. Inactivation continues for a validated time period. Following the inactivation time, the contents will be neutralised with sodium thiosulphate and the vessel contents stirred at a controlled temperature for a further 24 hours. Following neutralisation the solution will be adjusted to the required pH using either sterile sodium hydroxide solution of hydrochloric acid solution. The method used of having a second vessel for inactivation rather than doing it in the fermentor itself is in line with EC guidelines as there is no possibility of the inactivated material being re-infected. Inactivated antigen is collected into storage vessels and held in the suite until a test result indicates that it is inactivated and can be removed from the suite.

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There is an in-process control laboratory within the CL2 suite. In-process analysis will be performed within a Class II microbiological safety cabinet. Any infectious samples will be contained when they are transported to the QC laboratory. These samples will be surface decontaminated in the waste pass-through prior to leaving the facility. Decontamination and Waste Disposal Contaminated waste material will be treated and disposed of in accordance with exiting site procedures. Where possible all waste will be treated with moist heat decontamination either steamed in the vessel (liquid waste) or be autoclaved out of the suite or decontaminated within the vessel in the suite, e.g. by the use of proven chemical means. This is for both safety and operational purposes. Liquid waste will exit the fermentation suite via a dedicated waste pass-through autoclave. Fire water from the suite will be collected and decontaminated.

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6.0 SOCIO ECONOMIC

6.1 Introduction This section considers the impact of the proposed extension in the context of population and settlement, land use, employment and other impacts of a social and economic nature. The types of socio-economic issues which developments such as this typically raise (both during construction and operation) include: impacts on amenities and services in the area; additional economic opportunities; increased traffic; and impacts on existing land uses. References are made in this section to other environmental topics (such as traffic, visual, etc.) in so far as they impact indirectly on human beings; they are examined and assessed in detail in other sections of the EIS. The existing Elanco facility currently employs circa 100 personnel; it is anticipated that the proposed extension will result in up to 10 - 15 new permanent members of staff. During the 12 month construction period, it is estimated that construction employment numbers will increase gradually over the first few months, peaking at approximately 40 – 50 people including management and supervision staff and gradually reducing as construction is completed.

6.2 Methodology A desktop review of existing information was initially undertaken. This was followed by a site visit of the site and its environs. Relevant information and statistical sources used to inform this section include:

�

• The National Development Plan 2007-2013; • The National Spatial Strategy 2002-2020; • The Sligo County Development Plan 2005-2011; • The Draft Sligo County Development Plan 2011-2017; • The Sligo and Environs Development Plan (SEDP) 2010-2016; and • other major planning applications were also consulted.

Information from the Central Statistics Office (CSO) on population, demographics, household structure, employment status, etc. has informed the assessment presented in this section.

6.3 Description of the Existing Environment

6.3.1 Planning and Development Context

General The proposed extension will be adjacent to the existing Elanco production building facility. This facility is located in the Finisklin Industrial Estate which is

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approximately 1km north west of Sligo City centre and immediately to the west of the N4 Sligo Inner Relief Road. The proposed development site is located within the administrative area defined as Outer City and according to the Sligo and Environs Development Plan 2010 – 2016 is zoned as “BITP” which is defined as Business, Industry and Technology Park. This zoning has the specific objective of “promoting of office based businesses, technology companies and industrial units in dedicated business industrial parks of Finisklin, Oakfield, Rathbraghan/ Ballytirnan and Doonally”. A separate Planning Section (Section 4.0) provides a detailed assessment of how the proposed extension is consistent with the appropriate planning and development plans of the area.

Land Use Structure adjacent to the Site Finisklin has developed over the past 20 years as a significant industrial area. The Sligo Business & Technology Park in Finisklin, managed by the Industrial Development Authority (IDA), is a fully landscaped 42 hectare (104 acre) business park. A number of industrial sectors have located their businesses here including Abbott Laboratories (Medical Technologies), Stiefel Laboratories (Skincare/Healthcare Products), and companies specialising in engineering and food storage. As stated within the Sligo and Environs Development Plan 2010-2016, the Sligo Borough and County Councils recognise the importance of the IDA industrial estate at Finisklin. The area is a suitable location for business, industry and technology activities. It is easily accessible and close to the city centre. However, as this park is approaching maximum capacity, the need to provide new business/enterprise parks within the Sligo Borough has also been identified. The closest developed residential area to the proposed extension is the Rathedmond Estate which is located approximately 0.22km to the south east.

Socio Economic Factors With an estimated population of circa 25,000 in 2008, Sligo and its Environs (Sligo Borough and five adjoining Electoral Divisions) is the largest urban centre in the North-West. Given its location midway between Galway and Derry (approximately 140 km from each city), Sligo is the capital of a substantial territory in the North-West region. Along with its development potential in terms of existing infrastructure and services, Sligo’s strategic location was a critical element in its designation as a Gateway City under the National Spatial Strategy 2002-2020. The proposed extension forms part of the urban area of Sligo Borough, which has noticeably developed in south, west and northern directions in recent years. The

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Sligo Borough area can be regarded as the immediate area in terms of socio-economic impacts that potentially could arise from the proposed extension. This socio-economic impact assessment concentrates on the Sligo Borough and County Sligo in terms of population and employment and specifically on the general Sligo City area with regards to impacts on recreation, amenities and heritage.

6.3.2 Population Population Change In terms of the County, Region and State, population change is strongly influenced by migration and emigration rates, rather than birth and death rates. The mid to late 1980’s in Ireland was a period of heavy emigration, mainly due to the poor economic and employment situation. Census information shows that since 1990 there has been a large movement of people into the Country due to improvements in the economy of Ireland. Whilst the level of migration into the State has significantly slowed since 2007, the population of the State continues to increase. Table 6.1 shows the changes in population for the primary (Sligo Borough & environs2) and secondary (Sligo County) hinterlands of the proposed extension as well as the State in general.

Table 6.1 Population Change at State, Secondary and Primary Hinterland Level (Source: CSO Census of Population 1996, 2002 and 2006)

1996 2002 2006 % Change 1996-2002

% Change 2002-2006

State 3,626,087 3,917,203 4,234,925 +8% +8% Sligo County 55,821 58,200 60,894 +4% +5% Sligo Borough & environs 18,509 19,735 19,402 +7% -2%

During the period 2002-2006, the population of Sligo Borough and evirons decreased by 333 persons, from 19,735 to 19,402. This represents a loss of 2%, contrasting with the 7% population gain during the period 1996-2002. The overall population of Sligo County saw a steady population growth of 2,379 persons, or 4% between 1996 and 2002 and of 2,694 persons, or 5% between 2002 and 2006.

Over the ten year period from 1996 to 2006 the population of the State grew by approximately 16%, while the population of County Sligo increased by over 9% the population of the Borough increased by 5%. Over 40,000 persons (circa 66% of the County’s population) live in Sligo City or within 10 miles of it.

2 Sligo Borough and Environs as designated by the boundaries determined by the Central Statistics Office include the Borough and the 29 Electoral Divisions within 10 miles of the City Centre.

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According to the SEDP 2010-2016 the loss of population from the Borough to the surrounding areas is in the most part associated with the Rural Renewal Tax Incentive Scheme. This scheme applied to the southern and eastern parts of County Sligo and the adjoining areas of County Leitrim and led to a mini-boom in house construction in towns such as Tobercurry and Ballymote, in smaller villages like Ballysadare, Collooney and Coolaney, and in nearby settlements outside the County boundaries, such as Dromahair, Manorhamilton and Kinlough in County Leitrim. Following the publication of the Census 2006 reports, it became apparent that despite the overall Border Region’s population growing more than anticipated, the Sligo and environs area, as defined by Census boundaries, had lost 1.69 % of its population (333 residents). In summary, the proposed extension will be located in an area that has experienced a slight population decrease within the primary hinterland (within the 2006 period covered by the Census), but a strong increase in population within the secondary hinterland. This strong rate of population growth in the secondary hinterland of the subject site is indicative of the increasing job opportunities and the continuing expansion of the overall Sligo region.

Age Profile The age profile of the population is important in terms of the potential labour force, the demand for schools, amenities and other facilities and future housing demand. Tables 6.2 and 6.3 below show the approximate age profiles for primary (Sligo Borough & environs) and secondary (County Sligo) hinterlands of the proposed extension as well as the overall State profile. This allows comparisons to be made, for 2002 and 2006 figures respectively and allows the changes in the population profile to be compared between Census years.

Table 6.2 Age Profile at State, Secondary and Primary Hinterland Level, 2002 (source: Central Statistics Office Census of Population 2002)

0-14 %

15-24 %

25-44 %

45-64 %

65+ %

Total Persons

State 21 16 30 21 11 3,917,203 Sligo County 20 16 27 23 13 58,200 Sligo Borough and environs

18 21 29 20 12 19,735

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Table 6.3 Age Profile at State, Secondary and Primary Hinterland Level, 2006 (source: Central Statistics Office Census of Population 2006)

Table 6.2 shows that the age profile of the population of Sligo County in 2002 showed a slightly lower percentage within the 0-14 age group, at 20%, compared with the State average of 21%. Sligo Borough and environs recorded a lower figure compared to the Sligo County and the State figures, at 18%. At the other end of the scale the national figure for persons aged 65+ in 2002 was 11% of the population, with Sligo County, and Sligo Borough and environs being higher at 13%, and 12% respectively. In 2002 the percentage of the Sligo County population within the working age group (15-64) amounted to 66%, compared to the State average of 67%. The figure for Sligo Borough and environ was higher, reaching 70%. This may be as a result of the availability of relatively cheap accommodation in a smalltown or village setting, within a short commuting distance of Sligo City, which resulted in families in recent years in moving out of the City. Between the years of 2002 and 2006 the proportion of 0-14 year olds in the State remained at 21% and at Sligo County at 20%. Within the Sligo Borough and Environs during the same period the figure dropped from 18% to 16%. In 2002 the proportion of the State population within the working age group was 67% and this figure has remained the same up to 2006. Sligo County experienced a slight growth in the working age group, increasing from 66% to 67% between 2002 and 2006. Figures published in 2006 show approximately 70% of the Sligo Borough and Environs total population of 19,402, was of working age i.e. fell into the 15-64 age bracket. There were 3,116 children under 14 years and 2,577 aged 65 and over, giving a total dependency ratio of 2.4 to 1 (2.4 persons of working age for every child under 15 or senior over 64), a similar trend to 2002 figures. Data from the 1996, 2002 and 2006 Census of Population suggests that the reason for changes in the age structure may be partly attributed to a young population growing up and becoming working age. A trend visible in many Irish cities is the decrease of the younger population segments combined with a steady increase in the older-age groups.

0-14 %

15-24 %

25-44 %

45-64 %

65+ %

Total Persons

State 21 16 30 21 11 4,234,925 Sligo County 20 15 28 24 13 60,894 Sligo Borough and environs

16 20 30 21 13 19,402

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While the entire Sligo City population has risen by 893 between 1996 and 2006, there were 838 fewer children under 14 in 2006 compared to 1996, and 325 more people over 65 in Sligo Borough and Environs. In summary, the proposed extension will be located in an area that has a working age group slightly higher than the state average according to the most recent published data.

6.3.3 Housing Demand The land use pattern in Sligo and its environs area is characterised by limited residential development within the city centre, combined with expansive low-density housing estates and ribbon development in the outer city and on its fringes. The distribution of employee residences for the large manufacturing companies within the Sligo Outer City is wide with employees living in Sligo City and County, Co. Leitrim and beyond. According to the SEDP 2010-2016 a significant percentage of the population resides within Sligo City or within 10 km of the city. Housing demand arising directly from the proposed development is unlikely to create significant additional housing demand that has not already been anticipated in Regional and Local Planning Documents.

6.3.4 Employment Introduction To assess the potential impacts on employment it is first necessary to examine current employment patterns in terms of:

• The number of persons at work; and • Levels of unemployment.

Numbers at Work Between 1996 and 2006 there was a significant rise of 47% in the total number of persons in employment in the State. Table 6.4 shows changes that have occurred in the State, County Sligo and Sligo Borough and environs. Table 6.4 Numbers of people at work at State, Secondary and Primary Hinterland. (source: Central Statistics Office Census of Population 1996-2006)

Area 1996 2002 2006 1996-2006 % change

State 1,307,236 1,641,587 1,930,042 +47% Sligo County 20,204 23,927 27,235 +35% Sligo Borough and environ 6,803 8,214 8,670 +27%

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The number of people working which reside in County Sligo rose from 20,204 in 1996 to 27,235 in 2006 achieving growth percentage of 35%. The growth in the number of people working in the primary hinterland of Sligo Borough was less at 27%. Between 2002 and 2006 there has been significant growth in the labour force nationally and in each county in the west of Ireland. However, according to statistics compiled by the Western Development Commission (WDC) from Census data, the labour force in County Sligo had the lowest growth rate in the country at 12.4% for the period 2002-2006. This compares with 16.8% nationally and 17.4% within the Western Region. The labour force comprises the employed and the unemployed. The labour force participation rate is an important measure of the dynamism of an economy. The higher the labour force participation rate, the higher the proportion of the population actively engaged in the labour market, either working or seeking work. Nationally the total labour force participation rate was 62.5% in 2006. Overall in the Western Region, it was 60.1% with a percentage rate for Sligo of 60.3% being recorded in 2006. The number of people at work in 2006 is substantially higher in all geographical areas due to the strong economic growth in Ireland since 1996. There has however been a significant economic slowdown which has resulted in significant increases in unemployment since the 2006 Census data was published. Table 6.5 below indicates more recent employment trends at state level. It reflects the economic slowdown with higher unemployment being apparent.

Table 6.5 Recent Employment Status at State Level, 2008-2010 (source: Central Statistics Office)

Levels of Unemployment The Sligo and Environs Development Plan 2010-2016 identifies that Sligo needs a significant boost in terms of employment opportunities. The following are the key policies adopted by Sligo Borough and County Councils to promote economic development:

• facilitate and encourage the business, enterprise and industrial development

of Sligo as a Gateway City and economic growth driver for the North-West;

State Employment (thousands)

Oct-Dec 2008

Jan –Mar 2009

Apr-Jun 2009

Jul-Sep 2009

Oct-Dec 2009

Jan-Mar 2010

Total in employment 2,054.6 1,965.6 1,938.5 1,922.4 1,887.7

1,857.6

Total unemployed 169.7 222.8 264.6 279.8 267.4 275.0 Labour Force 2,224.3 2,188.4 2,203.1 2,202.3 2,155.2 2,132.7

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• liaise with the IDA, Enterprise Ireland and other relevant bodies to attract international and indigenous industry, enterprise and employment to the city; and

• ensure that employment-related development is maintained and consolidated, in particular with regard to the city’s promotion as a major centre for retailing, services, tourism and culture.

Table 6.6 below shows that unemployment levels fluctuated in the Sligo Borough between the years 1996 and 2006. There is no Census data available at this time for the local level employment in the years 2006-2010. However it is expected that national trends are reflected in both primary and secondary hinterlands. Table 6.6 Unemployment Rates at State, County and Local Level (source: Central Statistics Office)

Area 1996 % 2002 % 2006 % 1996-2006 %

change

State 12.9 8.8 4.4 -8.5 Sligo County 7.3 5.0 4.5 -2.8 Sligo Borough and environ 9.2 6.0 6.3 -2.9 As a result of the economic slowdown, unemployment rates have risen quite significantly from recent historical lows. Based on the Quarterly National Household Survey, the CSO estimate the unemployment rate increased from 10.2% in Quarter 1 of 2009 to 12.9% in Quarter 1 of 2010. This brings the unemployment rate to a level comparable with that of 1994 and 1995 when the unemployment rates were 14.7% and 12.2% respectively. There were increases of 6,100 (+9.4%) and 46,200 (+29.2%) in the numbers unemployed in the Border, Midland and Western and Southern and Eastern regions respectively in the same period.

Industry Sectors In terms of employment, there is an important manufacturing base in Sligo City, particularly in IDA’s business park at Finisklin, with firms including Abbott and Elanco. Other firms based in Sligo include firms such as Loftus Automation and Avenue Mould Solutions. Garmoore and Infacta are engaged in tool-making, precision engineering and information technology. While the number of manufacturing jobs has been constantly falling, employment in retail and professional services has seen a rapid expansion. Public-sector jobs also continue to represent a sizeable proportion of the Sligo City’s employment, due to employers such as Sligo Regional Hospital, Sligo local authorities, primary and secondary schools, third-level institutions, and several sections of central government departments.

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In summary the proposed extension will be located in an area which historically has a higher unemployment rate than the rest of the county and state. Therefore the SEDP 2010-2016 has identified Sligo and its environs as needing a significant boost in terms of employment opportunities. The number of manufacturing jobs in the area is also in decline.

6.3.5 Transportation �

The proposed development site is located immediately to the west of the N4 Sligo Inner Relief Road. Access to the existing Main Plant is gained via an access road located off the Finisklin Road. This access point will also be used when the proposed extension is operational. The Finisklin Road forms the North-West boundary of the site and links directly to the N4 Inner Relief Road in the east and with Finisklin Sea Road. Finisklin Road is the main road within the Industrial estate and provides access to a number of businesses located in the vicinity of the Elanco site. Transportation is dealt with in more detail in Section 14 of the EIS.

6.3.6 Tourism, Amenities and Recreation Sligo is situated between the Atlantic Ocean to the west and the shores of Lough Gill to the east. This location, an area of known outstanding beauty, favours tourism. Sligo’s Gateway has a primary role on the main touring route between the West and the North-West. A variety of options in terms of cultural, urban, coastal and upland interests, mean that Sligo is also ideally positioned in terms of tourism. According to figures published by the Western Development Commission, a total of 156,000 tourists visited Sligo County in 2006, generating revenue of €39million. According to the SEDP 2010-2016 the city has a number of public arts and cultural institutions including art galleries, theatres and public buildings, such as Hawk’s Well Theatre, the Factory Performance Space, Sligo Art Gallery and the Yeats Memorial Building. The city centre is crossed by the Garavogue River, which presents a natural amenity corridor and a sensitive ecosystem in the centre of the city. Protected natural heritage sites in the area include; Cummeen Strand/Drumcliff Bay (Sligo Bay) which is a designated candidate Special Area of Conservation (cSAC), a Special Protected Area (SPA) and a proposed Natural Heritage Area (pNHA) and Lough Gill a cSAC and a pNHA.

6.3.7 Human Health The proposed extension will be used to make Stellamune porcine (pig) vaccines and other similar products which are classified as biological materials. The Stellamune vaccine contains an inactivated whole bacterium which is an animal pathogen which cannot be transmitted to humans.

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However, biocontainment procedures will be implemented at the facility to prevent release into the environment and also to prevent cross contamination of the existing vaccine processes. The facility will be designed to operate in accordance with the Draft Safety, Health and Welfare at Work (Biological Agents) Regulations 2010 and also to international Good Manufacturing Practise (GMP) regulations. Please refer to Section 5.4.11 above for more detail on biosafety.

6.4 Impacts The degree of the impact is rated, following its description. This classification is based on the categories suggested in the ‘Guidelines on the Information to be contained in Environmental Impact Statements’ (EPA, 2002).

6.4.1 Planning and Development Context The proposed extension is located within the boundary of the site occupied by the existing Elanco Main Plant in the Finisklin Industrial Estate in Sligo City. This site is located within the administrative area defined as Outer City and according to the Sligo and Environs Development Plan 2010 – 2016 is zoned as “BITP” which is defined as Business, Industry and Technology Park. Therefore there will be a positive neutral impact in relation to planning and development requirements as the proposed development will be in line with local development objectives.

6.4.2 Population �

The proposed extension, once operational, will provide direct employment for up to 10 - 15 additional personnel. There will therefore be a negligible direct impact on the population of Sligo and its environs due to the relatively small scale nature of the proposed extension.

6.4.3 Housing Demand The proposed extension is not likely to increase the population of the immediate area. No effect on housing demand is predicted from the proposed extension of the existing Elanco facility.

6.4.4 Employment

The proposed extension, once operational, will provide direct employment for up to 10-15 additional personnel. The propose extension will also contribute to the security of employment for other employees on site. During the construction phase of the project it is estimated that employment on-site will increase gradually over the first few months of construction, to a peak of 40-50 persons and then fall gradually over the last few months as the project nears completion. It is estimated that this construction stage will last approximately 12 months. The actual numbers that will be employed may vary slightly to those indicated above, depending on operational start levels, level of activity on the rest of the site and other factors. This

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will result in a positive imperceptible impact on employment during construction and operation of the proposed extension. Although the proposed extension will not result in a significant increase of employment, the proposed development is consistent with the support of employment opportunities in the Sligo Borough. It is likely that, as for the existing production, within the facility the workforce will be drawn from a wide geographical area. In the current economic climate the employment associated with the project during both construction and operation will be a slight positive benefit to the immediate and secondary areas and will create a positive economic impact. Total capital investment is estimated to be circa €20 million. It is envisaged that local contractors, services and materials will be utilised where possible. Multiplier Effects Based upon research undertaken by the Economic and Social Research Institute, the direct expenditure on wages and salaries would have a multiplier effect upon further indirect or secondary service employment. According to the ESRI research, for every 100 jobs in direct manufacturing industry, there are 91 associated jobs in the supporting service industry. During operational phase, the proposed extension will result in the direct employment of up to 10-15 more personnel at the facility. Any multiplier effects resulting from this employment will be of negligible positive benefit.

6.4.5 History, Tourism, Amenities and Recreation It is anticipated that during the construction period temporary impacts on the amenity of the area will be negligible. Due to the character of land uses and buildings in the immediate vicinity, the introduction of new construction facilities is not an uncommon feature. The location of compounds and laydown areas at the site will be carefully considered to ensure that they do not cause adverse impacts to amenities in the locality. Other sections in the EIS address issues such as noise, air quality, visual etc. which are often the cause of adverse construction impacts. Where significant impacts are identified mitigation measures are proposed. Following construction, the operational phase of the proposed extension will have a negligible impact on local amenities.

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6.4.6 Transportation This section considers traffic in general terms with regard to its effect on human beings. Section 14 ‘Transportation’ gives a detailed analysis of all traffic impacts and proposed mitigation measures. The existing road network is currently operating within its capacity level; there will be an increase in traffic accessing the site, in particular during construction phase. The impact of the traffic generated by the proposed extension will not result in significant effects on the amenity of the local area. The proposed extension is not expected to have any residual impact on the local road network. Transportation mitigation measures are required at construction stage and are detailed within Section 14.

6.5 Do-nothing scenario If the proposed extension did not proceed the area would not benefit from an increase in employment which will result from the construction and operational phases of the proposed extension.

6.6 Residual Impact The proposed extension of the Elanco facility will have a slight positive long-term impact on Sligo City and County through continued and increased employment.

6.7 Mitigation No specific mitigation measures are proposed in this Section to ameliorate the impacts on human beings as the potential impacts are negligible.

6.8 Conclusions The proposed Elanco extension will have a slight positive long term impact on the immediate hinterland of Sligo Borough and Sligo through increased and continued employment and the associated indirect economic and social benefits.

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7.0 ECOLOGY

7.1 Introduction Scott Cawley Ltd. was commissioned by Jacobs Engineering to undertake an Ecological Impact Assessment of a proposed extension to an existing Elanco facility in the Finisklin Industrial Estate in Sligo City. This Ecological Impact Assessment provides an assessment of the likely significant impacts of the proposed extension on ecological features within the zone of influence of the proposed extension. The aims of this Ecological Impact Assessment were to:

• establish baseline ecological data for the proposed development site and other relevant areas;

• determine the ecological value of the identified ecological features; • assess the impact of the proposed extension on ecological features of value; • recommend mitigation measures to avoid, reduce and remedy the identified

impacts; and • identify any residual impacts after mitigation.

7.2 Methodology

7.2.1 Relevant legislation and policy context The assessment of the likely impacts of the proposed extension on ecological resources has had regard to the following policy documents and legislation: National and International Policy and Legislation

• Wildlife (Amendment) Act (2000); • Flora (Protection) Order, 1999; • European Communities (Natural Habitats) Regulations 1997 S.I. No. 94/1997,

as amended (SI 233/1998 & SI 378/2005), which transposes the European Communities (EC) Habitats Directive 92/43/EEC, (as amended) into Irish law;

• EC Birds Directive 79/409/EEC; • Planning and Development Act, 2000, as amended.

Relevant Local Policies and Plans

• Sligo and Environs Development Plan 2010-2016. References to relevant Objectives and Policies of these plans have been made in this report text where appropriate.

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7.2.2 Relevant guidelines The baseline ecology surveys, evaluation and impact assessment had regard to the following legislation and guidelines: General

• Guidelines for Ecological Impact Assessment in the United Kingdom (IEEM, 2006).

• Advice Notes on Current Practice (in preparation of Environmental Impact Statements) (EPA, 2003).

• Guidelines on the information to be contained in Environmental Impact Statements (EPA, 2002).

Habitats and flora

• Best Practice Guidance for Habitat Survey and Mapping (Heritage Council, January, 2010)

• Habitat Survey Guidelines (Heritage Council, Draft 2005). • A Guide to Habitats in Ireland (Fossitt, 2000).

Fauna

• Bat Mitigation Guidelines for Ireland (NPWS, 2006). • Bat Surveys: Good Practice Guidelines (UK Bat Conservation Trust, 2007). • NRA Series of Environmental Planning and Construction Guidelines (2005 –

2010) • Design Manual for Roads and Bridges Series, in particular Volume 10:

Section 4 Nature Conservation and Volume 11: Section 4 Assessment of Implications on European Sites (UK Highways Agency, 1971 to date)

7.2.3 Desk study A desk study was carried out in order to collect any available information on the local ecological environment. The following resources assisted in the production of this report:

• Ordnance Survey Ireland maps and aerial photography; • Data on species that are rare, protected or threatened located within the zone

of influence of the proposed development, as held by the National Park and Wildlife Service (NPWS) Database, and / or the National Biodiversity Data Centre (www.biodiversityireland.ie);

• Other relevant ecological publications, reports and literature (as provided in the Reference list at the end of this report).

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7.2.4 Consultation As part of the EIA consultation was carried out with the National Parks and Wildlife Service (NPWS) and Inland Fisheries Ireland. Meetings were conducted with these consultees on the 17th August 2010 seeking their comments on the proposed extension. Notes of the meeting can be found in Appendix 7.2.

7.2.5 Field surveys The site was surveyed on the 3rd of August 2010. The survey followed best practice and relevant guidelines and involved a detailed inspection of all external areas of the site. Habitat and Flora Surveys All habitat types were identified and classified using the Guide to Habitats in Ireland (Fossitt, 2000). Within each habitat dominant and abundant plant species, indicator species and / or species of conservation interest were recorded. Plant nomenclature follows that of the Checklist of the Flora of Britain & Ireland (BSBI, 2007), and horticultural plant species nomenclature follows The Horticultural Society’s Encyclopaedia of Garden Plants (Briskell, 1998). Fauna Surveys As opposed to floral investigations, the surveying of faunal usage of subject lands cannot be based upon direct sightings alone. The presence of fauna was substantiated through the detection of field signs such as tracks, habitats, markings, feeding signs, and droppings, as well as by direct observation. Likewise, bird species noted within the study area were recorded along with any notable bird habitats, droppings, or tracks. In addition, the likely fauna species were assessed in relation to the habitats present within the site. The habitats on site were assessed for signs of usage by protected fauna species and other fauna species of conservation importance. In addition the potential of the habitats and any buildings to support these fauna species was assessed. No internal inspections of the buildings were undertaken, as it was determined that the buildings would have very low potential to support roosting bats (see description in section 7.3).

7.2.6 Approach to Ecological Evaluation and Impact Assessment Site Evaluation Criteria The criteria used to assess the ecological value and significance of habitats are provided in Appendix 7.1. These follow the Guidelines for Assessment of Ecological Impacts of National Road Schemes (NRA, 2009) and are consistent with the approach recommended in the Guidelines for Ecological Impact Assessment in the United Kingdom (IEEM, 2006).

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Impact Assessment Criteria The impact significance for terrestrial and aquatic habitats has been assessed using the Guidelines for Ecological Impact Assessment in the United Kingdom (IEEM, 2006). Detailed Ecological Impact Assessment was undertaken for all Sensitive Ecological Receptors (as defined in Appendix 7.1) where there is potential to impact on these receptors due to the existence of a source-pathway-receptor link.3 Based on these guidelines, the criteria used to characterise impacts are outlined in Table 7.1 below. Table 7.1 Characterisation of Impacts Parameter Categories Type of impact Positive/ Negative Magnitude of impact Size or amount of impact Extent Area over which impact occurs (may be the same as

magnitude if whole habitat impacted) Duration Time over which impact is expected to last. For example,

described as Short-term, Medium-term or Long-term in relation to relevant species/ habitat time-scales.

Reversibility Temporary/ Permanent Timing and frequency Timing of impacts in relation to relevant life-stages or

seasons Likelihood of impact occurring

Near-certain: probability >95% Probable: probability 50-95% Unlikely probability 5-50% Extremely unlikely: probability <5%

An impact is considered to be ecologically significant if it impacts the integrity or conservation status of a Sensitive Ecological Receptor within a specified geographical area. If impacts are not found to be significant at the highest geographical level at which the Sensitive Ecological Receptor has been valued, then the impacts may be significant at a lower level. For instance there may be a significant impact at a local level on a species which is valued at an international level. The highest levels of impact significance for each Sensitive Ecological Receptor ‘value’ rating are shown in Table 7.2.

3 In ecological and environmental impact assessment, for an impact to occur there must be a risk enabled by having a 'source' (e.g. construction works at a proposed development site), a 'receptor' (e.g. a SAC or other ecologically sensitive feature), and a pathway between the source and the receptor (i.e. a watercourse which connects the proposed development site to the SAC). The risk of the impact does not automatically mean it will occur, nor that it will be significant. However, identification of the risk does mean that there is a possibility of ecological or environmental damage occurring, with the level and significance of the impact depending upon the nature and exposure to the risk and the characteristics of the receptor.

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Table 7.2 Maximum level of impact significance for Sensitive Ecological Receptors Ecological Sensitive Receptor ‘value’ rating

Highest significance level

International Importance Significant Positive/ Negative impact at International level National Importance Significant Positive/ Negative impact at National level County Importance Significant Positive/ Negative impact at County level Local Importance (higher value)

Significant Positive/ Negative impact at Local level

Local Importance (lower value)

Significant Positive/ Negative impact at Local level

Flora and fauna species have been evaluated in relation to the criteria set out in Appendix 7.1 which includes for example legal protection they may be afforded (at International or National level), their conservation status and local abundance. For instance, a species that is listed on Annex II or IV of the EC Habitats Directive is considered to be of ‘International’ importance. As above, this does not mean that an impact will necessarily be significant at an International level.

7.2.7 Limitations / Data Deficiencies The field survey work was conducted on the 3rd of August 2010. This is an ideal period for the survey of habitats, because most plants are in flower or fruit and are therefore easier to identify. Summer months are not considered to be an optimal time for surveys of Badger setts or Otter holts, because the tall vegetation can obscure entrances to burrows. However this was not a constraint on the Elanco site, as the vegetation was very short in most places, and in areas of higher vegetation it was possible to conduct a detailed search through the undergrowth. Therefore it can be concluded that the timing of the survey has not lead to any limitations or data deficiencies.

7.3 Description of Existing Environment

7.3.1 Overview The proposed development site is located in Finisklin Industrial Estate on the western side of Sligo City (Irish National Grid 167828, 336524). The surrounding lands contain a number of other industrial / pharmaceutical / administrative buildings, in addition to landscaped areas and lawns. These environments have been heavily influenced by construction work, and are generally unlikely to support important habitats or wildlife. The underlying geology of the area is limestone, which is likely to be well-drained. However no flora identified during site surveys suggested calcareous influences in

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the soil, and therefore it is possible that the surface soils in the area were composed of glacial till or imported topsoil, (although this could not be confirmed). It is expected that the scope of influence of the proposed extension will for the most part be limited to within the boundaries of the proposed development site.

7.3.2 Designated Areas Candidate Special Areas of Conservation (cSAC) are designated under the Habitats Directive (92/43/EEC). The EC (Natural Habitats) Regulations (1997) enable the protection, conservation and, where possible and necessary, the restoration of certain habitats and/ or species (habitats listed on Annex I, and species listed on Annex II of the Habitats Directive). Designated SACs are compiled within a framework of protected areas known as Natura 2000. Special Protection Areas (SPAs) are designated under the Birds Directive (79/409/EEC). They are protected for birds listed on Annex I of the Birds Directive, as well as for populations of regularly occurring migratory species. The Directive primarily obliges member states to conserve wetlands, especially those of international importance. This Directive seeks to protect any such areas important for birds from potential impacts of proposed developments. Natural Heritage Areas (NHAs) are designations introduced under the Wildlife (Amendment) Act (2000). Although many NHA designations are not yet fully in force under this legislation (referred to as proposed NHAs or pNHAs), they are offered protection in the meantime under planning legislation which requires that planning authorities give due regard to their protection in planning policies and decisions. The study area lies within 5km of two cSACs, one SPA and three pNHAs. A summary of the sites is listed in Table 7.3 below.

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Table 7.3 Designated Areas within 5km of the Proposed Development (information downloaded from www.npws.ie on 19 August 2010)

Site name and code

Designation Distance from Proposed Development

Designated features (habitats and species)

Relevant Legislation

Cummeen Strand/Drumcliff Bay (627)

SAC, pNHA 0.6km See Appendix 7.2 for full details. Annex I habitats for which the SAC has been selected are;

• Estuaries; • Mudflats and sandflats not

covered by seawater at low tide;

• Embryonic shifting dunes; • Shifting dunes along the

shoreline with Ammophila arenaria (white dunes);

• Fixed coastal dunes with herbaceous vegetation (grey dunes);

• Juniperus communis formations on heaths or calcareous grasslands;

• Petrifying springs with tufa formation (Cratoneurion).

Annex II species for which the SAC has been selected are: • Vertigo angustior (Whorl

Snail) and • Phoca vituline (Common

Seal).

EC (Natural Habitats) Regulations (1997), Wildlife (Amendment) Act (2000)

Cummeen Strand SPA (4035)

SPA 0.6km See Appendix 7.2 for full details. Annex I species for which the SPA has been selected are;

• Branta bernicla hrota (Light-bellied Brent Goose) (internationally important species)

• Pluvialis apricaria (Golden Plover),

• Limosa lapponica (Bar-tailed Godwit)

• Cygnus cygnus (Whooper Swan).

Additional species of conservation interest are: • Haematopus ostralegus

(Oystercatcher) • Tringa totanus (Redshank).

EC (Natural Habitats) Regulations (1997)

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Site name and code

Designation Distance from Proposed Development

Designated features (habitats and species)

Relevant Legislation

Lough Gill (1976)

SAC, pNHA 1.4km Annex I habitats for which the SAC has been selected are;

• Alluvial wet woodlands (a priority habitat)

• Old Oak woodlands • Natural eutrophic lakes,

Annex II species for which the SAC has been selected are;

• Petromyzon marinus (Sea Lamprey),

• Lampetra fluviatilis (River Lamprey),

• Lampetra planeri (Brook Lamprey),

• Austropotamobius pallipes (White-clawed Crayfish)

• Salmo salar (Atlantic Salmon)

• Lutra lutra (Otter) Annex I (Birds Directive) species for which the SPA has been selected are;

• Alcedo atthis (Kingfishers) • Sterna hirundo (Common

Tern) Additional plants of conservation intertest include:

• Yellow Bird's-nest Monotropa hypopitys,

• Lady’s Mantle Alchemilla glaucescens

• Ivy Broomrape Orobanche gederae

• Black Bryony Tamus communis

• Intermediate Wintergreen Pyrola media

• Bird's-nest Orchid Neottia nidus-avis

• Melancholy Thistle Cirsium helenioides

EC (Natural Habitats) Regulations (1997), Wildlife (Amendment) Act (2000)

Knocknarea Mountain And Glen (1670)

pNHA 4.75km Montane habitats with heath / bog. No site synopsis available.

Wildlife (Amendment) Act (2000)

Potential impacts upon European sites have been considered in a Screening Statement for Appropriate Assessment contained in Appendix 7.2. The pNHAs at Cummeen Strand and Lough Gill cover very similar areas to the SACs and therefore they have not been considered separately. As there is no link between the

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Knocknarea Mountain and Glen pNHA, there is no potential for impacts upon this site.

7.3.3 Records of Protected, Rare and Other Notable Flora and Fauna species Data from NPWS A search was undertaken of records of rare, threatened and protected species held by the NPWS, revealing records of Otter (Lutra lutra) and Fallow Deer (Dama dama) in the surrounding grid square G63 (records for many rare / protected species in Ireland are stored in a grid of 10km x 10km across the country). In addition, a data information request was submitted to the NPWS Research Branch for G63 and the adjacent G73, revealing many more records. The results are shown in Table 7.4. Table 7.4 Rare and Protected Species Recorded from the Surrounding 10km Square (information downloaded from www.npws.ie on 19th March 2010)

Latin Name Common Name

Sample Dates

Sample 10 km Square

Level of Protection

Red List Status

Flora Draba incana Hoary

Whitlowgrass 1500 - 1904

G63, G73 Rare

Hyoscyamus niger Henbane 1866 G63 Rare Pseudorchis albida Small-White

Orchid 1885 - 1989

G73 Flora Protection Order (1999)

Vulnerable

Saxifraga aizoides Yellow Saxifrage

1845 - 1984

G63 Rare

Fauna Austropotamobius pallipes

Freshwater Crayfish

2006 G63 Habitats Directive Annex II; Wildlife Act (as amended)

Dama dama Fallow Deer 1990 - 2005

G63, G73 Wildlife Act (as amended)

Lepus timidus subsp. hibernicus

Irish Hare 1991 - 2009


Lutra lutra Otter 1990 - 1991

G63 Habitats Directive Annex II & IV; Wildlife Act (as amended)

Near-Threatened

Martes martes Pine Marten 2004 - 2006

G73 Wildlife Act (as amended)

Meles meles Eurasian Badger

1990 - 2008


Mustela erminea subsp. hibernica

Irish Stoat 1969 - 1972

G73 Wildlife Act (as amended)

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Petromyzon marinus

Sea Lamprey 1983 G63 Habitats Directive Annex II

Indeterminate

Rana temporaria Common Frog 1962 - 2003


The habitats on the proposed development site are not considered suitable for most of these flora species, most of which are generally found in wet, upland areas. However Henbane can be found in waste ground, and therefore it is possible that it could occupy the Recolonising Bare Ground in the southeast of the site. However none of these species were found during surveys. Freshwater Crayfish and Sea Lamprey are species of aquatic habitats, and therefore would not be found within the proposed development site (which contains no standing water or watercourses). All other fauna species could potentially be found on the proposed development site, although none were observed during site surveys, and no breeding places were observed. It is possible that some of these species may use the area for feeding or commuting.

7.3.4 Field survey results Habitats and Flora The following habitat types were identified during the survey (categories taken from Fossitt 2000 are underlined) and Figure 7.4, Volume 3, ‘Site Habitat Survey Results’ illustrates the extent of all habitat types present within the study area.

• Treelines (WL2) • Hedgerows (WL1) • Ornamental / Non-native shrub (WS3) • Dry Meadows & Grassy Verges (GS2) • Amenity Grassland (GA2) • Recolonising Bare Ground (ED3) • Buildings and Artificial Surfaces (BL3) • BC4 Flower Beds and Borders

Woodland Treelines (WL2) Treelines were found along the southern and eastern site boundaries (see an example in photograph 7.1). Some scattered trees were also found along the northern and western boundaries. The trees surrounding the existing main plant were predominantly Poplars Populus spp., with some small Ash Fraxinus excelsior and Willows Salix spp. in the eastern corner, and a Silver Maple Acer saccharinum in the northwest corner. The field to the south of the main plant contained a line of ~10 large Cypresses Cupressus sp.

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Treelines provide habitat for a range of flora and fauna, and it was noted that many of the Poplar trees supported healthy growths of lichens. However, almost all of the trees on site were non-native, and therefore their value is lower than that of native trees. All treelines are considered to be of Local (low) ecological value. Hedgerows (WL1) Hedgerows were also found along the western and northern boundaries of the field in the southern part of the proposed development site (see photograph 7.2). One hedgerow was composed of low tightly-cropped Cypress trees, and the other of non-native shrubs. The hedgerows were thick and dense in places, and may provide habitat for small mammals and nesting birds. However as they are non-native, they are not considered to be as valuable as comparable hedgerows with native species, and therefore are considered to be of Local (low) ecological value at most. Ornamental Non-native Shrub (WS3) Non-native shrubbery was found around the sides of the main plant building (see photograph 7.2). It consisted of a number of non-native trees, shrubs and flowers, planted over a gravel substrate. It also includes some Flower Beds and Borders (BC4), but as the habitats are mixed and of similar ecological value they have not been mapped separately. As these areas have some importance for invertebrates, small mammals and birds, they are considered to be of Local (low) ecological value. Grassland Dry Meadows & Grassy Verges (GS2) The field to the south of the main plant contains a slightly modified form of Dry Meadow (see photograph 7.2). It contains a moderately diverse mixture of grass and forb species, some of which are typical of wet environments. The area is considered to be a future expansion area for Elanco, and has grown wild in previous years. It had previously been overgrown, but had been mown a few weeks prior to survey. It contained a mix of grasses including False Oat-grass Arrhenatherum elatius, Cock’s-foot Dactylis glomerata, Yorkshire-fog Holcus lanatus, Common Bent Agrostis capillaris and Timothy Phleum pratense, in addition to forbs such as Silverweed Potentilla anserina, Ribwort Plantain Plantago lanceolata, Daisy Bellis perennis, Dandelion Taraxacum officinale ag., Creeping Buttercup Ranunculus repens, Bush Vetch Vicia sepium, Common Chickweed Stellaria media, Meadow Vetchling Lathyus pratensis, Field Mouse-ear Cerastium fontanum and Dandelion Taraxacum officinale ag. Soft-rush Juncus effusus was also frequent, and may have been more abundant before mowing. The longer grass at the base of hedgerows supported some Common Knapweed Centaurea nigra, Meadowsweet

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Filipendula ulmaria, Common Couch Elytrigia repens and Redshank Persicaria maculosa. It may be of value for some meadow birds and invertebrates, but overall is considered to be of Local (low) ecological value.

Photograph 7.1 Dry Meadow vegetation in the foreground, with a Hedgerow and Treeline on the left side

Amenity Grassland (GA2) This habitat can be found around the northern and western parts of the proposed development site between the buildings and the roads (see figure 7.2). It was dominated by Perennial Rye-grass, in addition to other common grasses and forb species such as Yorkshire Fog, Rough Meadow-grass Poa trivialis, Daisy, Dandelion and Creeping Buttercup. It appeared to be mowed on a regular basis. It is not considered to be of ecological value.

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Photograph 7.2 Amenity Grassland, Ornamental non-native shrubs and some scattered Poplar trees

Disturbed Ground Recolonising Bare Ground (ED3) Recolonising ground was found in the southeastern corner of the proposed development site adjacent to some service buildings (see photograph 7.3). It was composed of a diverse range of colonising annuals and perennials on gravel and mud, including Knotgrass Polygonum aviculare, Nipplewort Lapsana communis, Colt’s Foot Tussilago farfara, Prickly Sow-thistle Sonchus asper, Smooth Sow-thistle Sonchus oleraceus, Oxeye Daisy Leucanthemum vulgare, Great Willowherb Epilobium hirsutum, Rape Brassica napus, Hedge Bindweed Calystegia sepium, Common Ragwort Senecio jacobaea and a range of common grasses and forbs. Some immature Willow and Ash trees were also present. This area contains a high diversity of species (>35) and vegetation structure in a relatively small area, and is likely to be of importance for local invertebrates, birds and small mammals, which would be particularly important considering the urban nature of the surrounding areas. Therefore this habitat is considered to be of Local (high) ecological value.

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Photograph 7.3 Recolonising Bare Ground in the southeast of the site.

Built Land Buildings and Artificial Surfaces (BL3) All buildings and artificial surfaces (roads and pavements) were classified as BL3 habitat. They supported very limited vegetation cover other than some occasional bryophytes, lichens or other common colonising species. Their potential interest for fauna, primarily bats, is discussed below. They are not considered to be of ecological value. Habitats within the Surrounding Area The proposed development site is located in any industrial estate, and is surrounded by industrial facilities set among lawns, landscaped shrubs / flower beds and hedgerows. Most of the grasslands are mowed and kept at a low level, but some are in a less-intensively managed state. The majority of hedgerows and landscaped areas appear to be composed of non-native species. There are no watercourses on the site, and none were observed within approx. 50m of the site. The EPA watercourse mapping service shows few watercourses in the surrounding area, although the Garvoge estuary lies approx 600m to the northeast. The underlying geology is limestone, and therefore it is possible that the water drains directly into soils and bedrock rather than flowing across the surface.

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Fauna Badgers Meles meles There were no signs of Badgers in the vicinity of the proposed development site, although it is possible that Badgers may use the site for feeding or commuting purposes. Bats No signs of bats (e.g. droppings) were observed around the exterior of the existing plant, and overall the buildings would not be considered to provide ideal roosting opportunities for bats. A maintenance worker reported that no evidence of bats had ever been found within any buildings. A large number of flood-lights were observed around the exterior of the existing plant, and it was reported that all areas immediately adjacent to the plant are lit throughout the night for security reasons. This is likely to completely exclude bats from the proposed development site (excluding the dry meadow to the south), as most bats generally avoid feeding in bright areas. It is expected that bats would not roost within the buildings on the proposed development site, and that foraging / commuting opportunities within the immediate surroundings would be extremely limited. Therefore it is expected that the proposed development site is not of importance for bats, and consequently no internal bat inspections or external bat-detecting surveys were undertaken. Birds Some common species were observed on the proposed development site, including Jackdaw (Corvus monedula), Rook (Corvus frugilegus), Magpie (Pica pica), Wren (Troglodytes troglodytes) and Blackbird (Turdus merula). No bird species of conservation importance were observed on the proposed development site. Some large, untidy nests were observed in the Cypress trees along the southern boundary of the dry meadow, which are likely to be of common species such as Woodpigeon (Columba palumbus), Collared Dove (Streptopelia decaocto) or (Corvids Corvus spp). No nests were observed in any of the Poplar species. Other species The proposed development site may be used by a range of small mammals including Hedgehogs (Erinaceus europaeus) and Pygmy Shrew (Sorex minutes). Common Lizards (Zootoca vivipara), Smooth Newt (Lissotriton vulgaris) and Common Frogs (Rana temporaria) may occupy parts of the proposed development site, although it is noted that there are no wet areas in which amphibians might breed.

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7.4 Characteristics of the Proposed Extension The proposed development will involve the construction of an extension on the eastern side of the existing plant and the creation of road connections in the northeast and northwest of the site. This will involve the removal of areas of Built Land, Amenity Grassland, Ornamental / Non-native Shrubs and some scattered trees. The site of the proposed extension is shown in Photograph 7.4, and one of the proposed road links would pass through the area shown in Photograph 7.2.

Photograph 7.4 Location of the proposed extension to the existing main plant facility. This part of the proposed extension would take place entirely on Built Land (BL3) habitat

7.5 Summary of Ecological Evaluation Table 7.5 provides an ecological evaluation of all identified Sensitive Ecological Receptors. Sensitive Ecological Receptors (those features classified as Local (high) or above) and are defined as per the criteria set out in Appendix 7.1, which takes into consideration legal protection, conservation status and local abundance of ecological features.

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Table 7.5 Ecological Evaluation of Sensitive Ecological Receptors

Habitat / Species

Highest Ecological

Valuation Level

Ecologically Sensitive

Receptor?

Does a source-pathway-receptor

link exist? (i.e. is there potential

to impact on the feature?)

Designated Sites Cummeen Strand/Drumcliff Bay cSAC, pNHA (627)

International Yes Yes

Cummeen Strand SPA (4035)

International Yes Yes

Lough Gill cSAC, pNHA (1976)

International Yes No

Knocknarea Mountain And Glen pNHA (1670)

National Yes No

Habitats Hedgerows (WL1) Local (low) No Yes Treelines (WL2) Local (low) No Yes Ornamental / Non-native Shrubs (WS3)

Local (low) No Yes

Dry Meadow (GS2) Local (low) No Yes Amenity Grassland (GA2) None No Yes Built Land (BL3) None No Yes Recolonising Bare Ground Local (high) No Yes Fauna Birds Local (high) Yes Yes

7.6 Impacts As per relevant guidelines, likely significant impacts have been assessed for Sensitive Ecological Receptors only, as listed in Table 7.5 above. An impact is considered to be ecologically significant if it is predicted to affect the integrity or conservation status of a Sensitive Ecological Receptor at a specified geographical scale.

7.6.1 Construction Phase Impacts Designated sites There will be no direct impacts upon any designated sites, as all are located more than 600m from the site boundaries. Potential indirect impacts upon Natura 2000 sites have been addressed in a Screening Statement for Appropriate Assessment contained in Appendix 7.2.

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Habitats and Flora The extension to the existing main plant will be constructed upon hard-surfaced areas on the eastern side of the main plant. This area is classified as Built Land (BL3), and is considered to be of no ecological value. The proposed road access points in the northeast and northwest of the site will require the clearance of small areas of Artificial Surfaces, Amenity Grassland, Ornamental / Non-native Shrubs and some scattered trees. The first three habitats are considered to be of low ecological value. Depending on the scale of the works, some Poplar, immature Ash or Silver Maple trees may require removal. These trees are considered to be of Local (low) value, but the proposal would involve the removal of less than 5% of the trees on site, and therefore impacts would not be considered to be significant. The proposed development will also involve some additional landscaping works (e.g. hedgerows) along the northern boundary of the site, which would replace any existing trees that will be removed. The proposed extension will not result in any disturbance to the mature Treelines, the Dry Meadow, or the Recolonising Bare Ground. It is possible that surface water runoff may carry pollutants from the proposed development site into the surrounding lands. There are no nearby watercourses that may be affected, however due to the presence of limestone bedrock it is possible that this material may be carried into groundwater and carried offsite. This would have potential to affect habitats or fauna off-site. Fauna Due to the nature of the habitats that will be removed, it is not expected that the development would result in significant impacts upon mammals, reptiles or amphibians. No bird nests were observed in any of the trees that might require removal, and therefore no impacts would be expected upon birds. However it is possible that birds may create nests in the trees prior to the onset of construction works, which may result in death or disturbance of birds and their nests.

7.6.2 Operational Phase Impacts Designated sites As noted for the construction related impacts listed above, the proposed development will not cause any direct impacts upon any designated sites. Potential indirect impacts upon Natura 2000 sites have been addressed in a Screening Statement for Appropriate Assessment contained in Appendix 7.2.

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Habitats and Flora The proposed extension will be self-contained and will incorporate appropriate treatment for any materials produced during its operation. Surface water runoff from the building will be collected and discharged into the local surface water sewer, as is currently the case in the existing development, which ultimately is discharged to Sligo’s wastewater treatment plant. Foul water which is pH corrected will also be discharged into the local foul water sewer, which ultimately is discharged to Sligo’s wastewater treatment plant. Fauna It is expected that there will be no operational impact upon fauna.

7.7 Mitigation Designated Sites Mitigation measures relating to the protection of designated sites during construction works are set out in the Screening Statement for Appropriate Assessment contained in Appendix 7.2. Protection of Habitats All construction works will be largely limited to the footprint of the construction works or in existing hardstanding areas. Limited works, however, (including excavation, material storage or site compounds) will take place within or adjacent to the Treelines, Dry Meadow or Recolonising Bare Ground habitats. If required, exclusion zones will be created around these areas (allowing for root protection zones) in order to demarcate areas of sensitive habitats. Some existing newly planted tress may have to be removed during construction. Additional tree and hedgerow planting will be added along the northern boundary of the site, and this should include only native and naturalised tree species. This would provide greater ecological value than non-native species. The appointed contractor will have regard to the following guidelines to ensure that groundwater is adequately protected from construction work:

• Requirements for the protection of fisheries and habitats during construction and development works at river sites. Eastern Regional Fisheries Board (2006).

The contractor will prepare a method statement, which will have regard to the above and advice from Inland Fisheries Ireland, and will include specific measures in relation to the following:

• Methods to control run-off of silt and suspended solids; • Response measures to potential pollution incidents; • Appropriate storage (e.g. on impermeable surfaces) of fuels, oils, greases

and hydraulic fluids; • Control of run-off from concrete mixing;

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• Appropriate locations and size of stockpile areas for sands and gravel; and • Inspection and maintenance of settlement ponds if they are proposed as a

construction control measure. Nesting birds It is an offence under the Wildlife Act 1976 (as amended) to intentionally kill birds or destroy nests. It is recommended that in accordance with best ecological practice, hedgerows, trees, scrub and woodland areas will not be felled between 1st March and 31st August.

7.8 Residual Impacts Some mitigation measures have been proposed to protect habitats in other parts of the site, to manage surface water runoff, and to protect breeding birds. Due to the small-scale nature of the proposed extension and the low ecological value of the habitats on which it will take place, the proposed extension will not lead to any significant impacts upon habitats, flora or fauna.

7.9 Monitoring No monitoring is recommended.

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8.0 SURFACE WATER AND DRAINAGE

8.1 Introduction

This section discusses the existing and proposed surface water drainage systems, including water quality issues, assessing the potential impacts of the proposed extension and the mitigating measures that will be implemented to ensure that the quality of water bodies are not compromised.

8.2 Description of the Existing Development

There is no direct release of surface water from the existing facility to surface water bodies. The surface water drainage network on site drains surface water run off from hardstanding and roof areas to combine with the process water and foul water systems within the site boundaries. See Figure 8.2 for the existing site drainage plan. The flow is then directed off-site into the local authority combined system before discharging to Sligo’s wastewater treatment plant (WWTP). The WWTP provides tertiary treatment and discharges to Sligo Harbour Estuary (Cummeen Strand SAC). At present, the combined discharge is not treated on site, but is monitored at a point downstream of a new pH correction unit prior to its discharge to foul sewer. The existing facility is supplied with mains water distributed by Sligo Borough Council. Existing usage is approximately 63m3/day. A sprinkler/firewater holding tank is located adjacent to the site. A diesel fuel store delivery area with a concrete pad designed to contain the volume of an approved delivery tank fuel compartment is located on site. On delivery of fuel, a valve at the pad’s sump must be manually closed to mitigate against fuel leaks/spill to the sites surface water drainage lines. There is currently no interceptor in place downstream of this containment area. However, as part of the sites approved capital projects, interceptors are due to be installed in the coming months. The existing concrete-walled bunds containing two double-skinned metal diesel fuel tanks are not fully impermeable to fuel spills. However, all fuel oil deliveries are supervised and documented with standards operating procedure in place and training provided for these activities. These fuel tanks will also supply the proposed extension.

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8.2.1 Description of the Proposed Extension The proposed extension will operate under the existing facility conditions, with new surface water, foul and process water lines constructed in the northern section of the site. See Figure 8.2 for the site drainage plan. The effluent will be combined and discharged with the existing facility effluent, into the local authority sewer. There will be no direct release of surface water from the proposed extension to surface water bodies. The proposed extension is expected to discharge an additional 4 - 5m3/day of foul, process and surface water off site with the option to increase to 9-10 m3/day, to the Sligo WWTP. The composition and characteristics of the discharge and the ability of the WWTP to facilitate this additional discharge is discussed further in Section 15 – Waste Management. It is anticipated that mains water usage will increase by 25-50% on operation of the proposed extension. The existing fire water tank, diesel fuel store delivery area and diesel fuel tanks will be utilised for the proposed extension. If a fire event occurs, the sprinkler system will be automatically activated in the CL2 area and fire water will in the first instance be contained within this area. A dedicated drain system will then be used and will channel the fire water to a dedicated fire water retention tank. The waters will be held in the tank until tested and the disposal route agreed by site personnel and the relevant authorities. If it is deemed that the waters are suitable for discharge, then they will be transferred to the site waste water neutralisation tank where they will undergo normal site waste water treatment and discharge. Where the waters are deemed to not be suitable for inclusion with the site waste waters, then they will be dealt with in a manner approved by site personnel and the relevant authorities.

8.2.2 Fort Dodge Laboratories Ireland Limited IPPC License Elanco (Fort Dodge) currently hold an Integrated Pollution Prevention and Control (IPPC) license for the facility (P0090-01). The existing IPPC license will be amended to include the flows from the proposed extension and submitted to the EPA for approval. As no surface water is released directly from site to surface water bodies, the IPPC contains monitoring requirements and conditions for emission to sewer. Monitoring of emissions to sewer is undertaken upon discharge from the facility. Surface water is not separately monitored on the site, as this combines ultimately with process waste water and foul water prior to connection to the Sligo Waste Water Treatment Plant.

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8.3.1 Methodology of Assessment – Water Quality Water Quality Baseline A desk study was carried out to collate the available information on water quality. Publicly available information, held by the Environmental Protection Agency (EPA), National Parks and Wildlife (NPWS) and Western River Basin District (Water Matters) was reviewed.

The Existing Environment The Elanco site lies within Hydrometric Area 35, Sligo Bay and Drowse. The catchment is drained by the River Drowse and all streams of the hydrometric area enter tidal water in Sligo Bay and between Lenadoon Point and Aughrus Point, Co. Donegal. The Garavogue River, located to the north east of the Elanco site, flows into Garavogue Estuary which forms part of Sligo Bay. The Elanco site lies within the Western River Basin District (WRBD).

Designated Sites A number of designated sites are located within 1km of the proposed extension, namely Cummeen Strand/Drumcliff Bay (Sligo Bay) proposed Natural Heritage Area (pNHA 000627), Cummeen Strand/Drumcliff Bay (Sligo Bay) Special Area of Conservation (SAC 000627) Cummeen Strand Special Protected Area (SPA 004035). However, there is no direct link surface water link to these sites. These designated sites are discussed further in Section 7 – Ecology.

EPA Water Quality Database A review of the information held by the EPA (www.epa.ie), including water quality mapping and water quality reports was carried out to determine recent status and trends in the water quality of the Garavogue River in the vicinity of the proposed extension. The Environmental Protection Agency (EPA) assess the water quality of rivers and streams across Ireland using a biological assessment method, which is regarded as a representative indicator of the status of such waters and reflects the overall trend in conditions of the watercourse. The Q index or biotic indices is used as a classification system for river water quality, having index values of Q1, Q2, Q3, Q4 and Q5. Intermediate classification values are also used (Q1-2, 2-3, 3-4 and 4-5) to denote transitional conditions (EPA, 2005). The biotic indices are related to the four water quality classes as presented in Table 8.1 below.

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Table 8.1: EPA River Water Quality Classification

Biotic Index (Q value)

Quality class Pollution status

Q5, Q4-5, Q4 Class A Unpolluted Q3-4 Class B Slight pollution

Q3, Q2-3 Class C Moderate pollution Q2, Q1-2, Q1 Class D Serious pollution

The Water Framework Directive 2000/60/EC came into force on the 22 December 2000 and was transposed into Irish legislation through S.I. 722 of 2003, European Communities (Water Policy) Regulations 2003. The legislation provides a co-ordinated approach to water policy across Europe, and the establishment of a management structure in which to manage future water policy. The Directive requires that member states must implement the necessary measures to prevent deterioration of the status of all bodies of surface water. The key objectives of the Directive are to:

• Protect all waters, including rivers, lakes, groundwater, transitional and costal

waters; • Achieve “Good Status” in all waters by 2015, and maintaining “High Status”

where it already exists; and • Have water management structure based on River Basin Districts.

Under the Water Framework Directive, 2000 the Q value is used similarly to denote the status of a waterbody at that sampling location, with five status categories. Table 9.2 below shows the classification. "Condition" refers to the likelihood of interference with beneficial or potential beneficial uses.

Table 8.2: Water Framework Directive Classification

Q Value Index Status Condition Q5 High Satisfactory

Q4, Q4-5 Good Satisfactory Q3, Q3-4 Moderate Unsatisfactory Q2, Q2-3 Poor Unsatisfactory Q1, Q1-2 Bad Unsatisfactory

With regards to the classification of river water quality, the closest EPA monitoring station to the Elanco site is The Mall on the River Garavogue, approximately 1.5km east. The water quality at the monitoring station is reported as Q4-5 in 2006 and Q4 in 2009.

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The EPA reports that although ecological conditions remained satisfactory at The Mall in Sligo city in 2009, a slight deterioration from high to good status was noted. Water levels were high due to extensive rainfall all summer, and high levels of silt were observed. Domestic rubbish was a feature of the site, both in-stream and on the banks.

Garavogue Estuary The Garavouge River flows into the Garavogue Estuary (IE-WE-470-0100), in which the Sligo Waste Water Treatment Plant outfall is located. The Garavogue Estuary is a transitional waterbody with an overall ‘Good’ status under the Water Framework Directive classification. In terms of risk to the waterbody, the Western River Basin Management Plan classifies the Garavogue Estuary as ‘Probably as risk’.

Local Flooding The Office of Public Works (OPW) provides a national flood hazard mapping service. (www.floodmaps.ie). The mapping indicates that no flood events have been recorded by the OPW in the area of the proposed extension. The closest occurring flood events (recurring Flood ID 4949) have been recorded at Finisklin Road, adjacent to the point that the railway line crosses the road, approximately 800m from the Elanco site. The flood is cited as rare, but reoccurring, during extreme high tides and heavy rain.

8.4 Impacts Discussion on the following is separated into a description of potential construction impacts and potential operational impacts.

8.4.1 Construction Phase Impacts There will be no direct impacts on local watercourses or the River Garavouge, Sligo Harbour or the Garavouge Estuary (Cummeen Strand SAC, Cummeen Strand/Druncliff Bay SPA and pNHA) during the construction of the proposed extension. The closest watercourse is located approximately 600m from the proposed extension, and no known surface water drainage ditches are present in the vicinity. There shall be no release of surface water from site during the course of construction works, with all surface water discharging to foul sewer. In the unlikely event that contamination occurs during construction, potential causes may be:

• inappropriate handling and storage of fuels, chemicals and oils; • inappropriate handling and storage of hazardous materials and wastes,

including cement, cleaning products, waste electrical and electronic components, batteries, asbestos, wood preservatives, and contaminated soil;

• leakage of drains; and

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• Suspended solid release i.e. from water in excavations, wheel wash area and overland flow into road drains.

The magnitude of these potential impacts is dependant on the mitigation and site management practices implemented during construction. The mitigation measures to address these impacts are described in Section 8.5.

8.4.2 Operational Phase Impacts During the operational phase of the proposed extension, all surface water run off from the site will be discharged to foul sewer. The proposed development site is currently hardstanding, and therefore no increase in impermeable areas/surface water run off from site will occur. Surface water run off has the potential to be contaminated with silt and hydrocarbons such as oils, fuels, lubricants, and chemicals from cars and delivery vehicles present on site which may subsequently enter the local authority foul sewer system and subsequently the Sligo WWTP. The discharge from site will be monitored and reported under the conditions of the IPPC license for the facility. All emissions from site will be directed to foul sewer. Appropriate design, control and monitoring measures will be in place to limit to consequence of these impacts, namely the IPPC license for the facility.

8.4.3 Do-Nothing Impact Should the proposed extension not be constructed, then the surface water runoff will not be altered from the existing run off rate, and continue to be discharge to the local authority sewer off site.

8.5 Mitigation The following sections outline the best practicable mitigation measures that will be employed on the site during construction and operational phases.

8.5.1 Construction Phase Mitigation Mitigation measures applicable to both soils, surface and ground waters are provided in Section 9 Soils, Geology and Hydrogeology and should be referenced for construction mitigation measures relating to surface waters. All surface water runoff on site during construction will be contained and discharged to foul sewer.

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8.5.2 Operational Phase Mitigation A range of mitigation measures have been developed to address surface water quality, drainage and attenuation issues in light of current requirements. Measures include:

• All surface water run off from the existing facility and the proposed extension

will be discharged to local authority foul sewer, and in accordance with the IPPC licensing and monitoring requirements for the facility;

• The manually operated shut off valve is located on the foul, surface water, process waste water line prior to discharge off site to prevent contaminated water used in the event of a fire, being automatically released to the local authority sewer without prior consent/notice;

• The bunded fuel delivery area will be made impermeable to prevent fuel release off site discharging to local authority sewer; and

• All containers holding bulk chemicals, wastes and fuels will be stored on spill trays with a capacity to contain 125% of the volume of material stored.

8.5.3 Operational Water Quality (To Foul Sewer) The emissions to sewer will be monitored in accordance with the conditions of IPPC licence P0090-01 which will be amended to incorporate the proposed extension.

8.6 Residual Impacts The mitigation measures outlined above will be implemented to ensure that there are no significant residual impacts, thus ensuring the protection of water courses, and designated areas.

8.7 Conclusions

The surface water runoff from the proposed extension will be combined with process and foul water on site, and discharged to the local authority sewer and onto the Sligo Waste Water Treatment Works. There will be no other release of surface water from the site.

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9.0 SOILS, GEOLOGY AND HYDROGEOLOGY

9.1 Soils & Geology

9.1.1 Introduction

This section of the EIS describes the natural characteristics of the proposed extension site and its immediate surroundings, in terms of landscape and topography, insitu ground conditions, drift and bedrock geology. Geology and soils determine the environmental characteristics of a region as geology has an influence on landform and provides the parent material from which soils are created. An assessment is made of the likely impact of the proposed extension on these resources and where possible, mitigating measures are put forward to reduce the impact of the proposed extension. References are made in this section to other environmental topics (such as construction, waste disposal, etc.) in so far as they impact indirectly on soils, and geology; they are examined and assessed in detail in other sections of the EIS. The impact of the proposed extension on the existing hydrogeological environment is considered within Section 9.2.

9.1.2 Legislative Background

As no formal methodology for assessing the extent and degree of impact that the proposed extension may have on the geological aspects of the environment exists, an approach has been adopted, based on the document produced by the Institute of Geologists of Ireland, “Geology in Environmental Impact Statements – a Guide”, September 2002. This document outlines the likely impacts and potential mitigation measures for geological issues by topic, although no significance criteria are given by which the impact can be rated.

9.1.3 Methodology As the Geotechnical Investigation (GI) was ongoing, this section of the EIS is based on a desktop review of existing information relating to the soils and geology of the area. In addition, a site walkover has been undertaken to gather specific information relating to the site and the surrounding area. The following sources and reports were consulted during the compilation of this report:

• Geological Survey of Ireland (GSI), Geology of Sligo-Leitrim 1:100,000 Scale Map, Sheet 7 bedrock geology series;

• Geological Survey of Ireland (GSI) Public Data Sets Viewer Maps including Geohazards, Quaternary Geology, Minerals, Geological Heritage, Groundwater, Geotechnical and Bedrock Datasets and;

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• Geological Survey of Ireland (GSI) Groundwater Protection Schemes Maps including groundwater vulnerability (Interim Vulnerability Map), aquifer category, bedrock boundaries, hydrogeological data, Teagasc subsoils data, depth to bedrock data, source protection areas.

Two reports commissioned by Fort Dodge Laboratories Ltd. in 1999 were consulted to scope the August 2010 Ground Investigation and to supplement the information relating to the soils and geology, particularly of the shallow superficial deposits. These reports were:

• Dames and Moore, Phase I Environmental Assessment (1999) • Dames and Moore, Phase II Soils Investigation (1999)

Seven historic ground investigation reports undertaken in the vicinity of the Industrial Estate have been received from the GSI. Three of these reports were carried out within approximately 250m of the proposed extension location. The ground conditions recorded during these investigations are representative of the superficial geology surrounding the site and allow interpolation of the ground conditions beneath the site of the proposed extension. These reports included:

• Extension to existing premises at Bruss Ltd (1984) • Proposed Extension to Stiefel Laboratories (1990) • Extension to Abbott Ireland warehouse, pumps building and car park (2003)

An unpublished report from the GSI and Appendix D of the Sligo County Development Plan 2005-2011 were consulted to evaluate the potential impact of the proposed extension on sites containing a Geological Heritage value.

• “The Geological Heritage of Sligo. An Audit of County Geological Sites in Sligo” (GSI, 2004)

• Sligo County Development Plan 2005-2011, Appendix D “County Geological Heritage Sites”

9.1.4 Description of Existing Environment

The receiving environment is discussed below in terms of landscape and topography, previous land use, geology and ground conditions and bedrock geology. The section on geology and ground conditions is sub-divided into topsoil, made ground and glacial deposits. Landscape and Topography of the site and surrounding Area The topography surrounding the proposed site is generally flat with a regional downward slope, sloping northwards towards the estuary from the Strandhill Road. The local site elevation is approximately 10 m above ordnance datum (above mean sea level) which falls to sea level (0m OD) on the Cummeen Strand to the North of the site.

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The level of the site, in the area of the proposed extension is slightly below that of the surrounding area and is situated approximately 1.5m below the road that forms the northern site boundary. The topography of the area of the extension is flat and is currently a hard standing area used for the storage, delivery and loading of materials to and from the plant. To the south of the hard standing is a slope, approximately 2m high which drops down to an access road and an area containing a water tank storing water for the fire protection sprinkler system. The eastern boundary, consisting of a fence and a hedgerow is adjacent to the area of hard standing. The neighbouring site is approximately 1.5m above the level of the site at the northern end and falls to approximately 2m below at the southern boundary. The ground level slopes gently downhill to the east of the proposed extension on the adjacent site. The existing plant building forms the western boundary of the proposed extension location.

Previous Land use The Dames and Moore Report (1999) details the previous land use associated with the area based on a review of historic maps and photographs. The area of the industrial estate is reported to have been green fields, presumably agricultural in use, prior to the development of several industrial units by the IDA from 1979 onwards. There is a disused municipal dump which was closed in 1996, down gradient of the proposed site location, approximately 350m north east of the industrial estate.

Geology and ground conditions The Teagasc subsoil data, available from the GSI for the area of Finiskilin, indicates that the subsoils beneath the site of the proposed extension consist of Made Ground and Till chiefly derived from Metamorphic rocks. The detailed description of the strata beneath the site location are interpolated from several ground investigation reports provided by the GSI and are consistent with the Teagasc subsoil data from the GSI. Three of the investigations, consisting of seven boreholes, sixteen trial pits and the associated insitu and laboratory testing, were undertaken within 250m of the proposed extension. The ground conditions, typical of all three sites are summarised in Table 9.1.1. The depths of made ground have been inferred from observations made during the site walkover, the investigations carried out by Dames and Moore (1999) and are specific to the site of the proposed extension.

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Table 9.1.1: Typical interpreted ground profile

Stratum Typical Depth to top

of strata (m bgl)

Thickness of strata min - max (m)

Topsoil/Made Ground 0m bgl 0.3 – 1.5m

Soft – firm sandy gravelly CLAY/SILT with cobbles and boulders [Glacial Till]

1.5m bgl 0 – 1.7m

Firm – v. stiff sandy gravelly CLAY/SILT with

cobbles and boulders [Glacial Till]

2.5m bgl >1.4 – 3.5m

Limestone/Shales (Glencar Formation)

>4.2 - 6m Not proven

Topsoil Topsoil is present on the surface of the grassed verge to the north of the site of the proposed extension. Based on the details contained within the previous ground investigations, the topsoil is expected to be present from the ground surface to a depth of 0.3m bgl.

Made Ground Made ground is likely to be present beneath the southern portion of proposed extension site and is likely to be associated with the construction and landscaping of the existing facility. The northern portion of the site is approximately 1.5m below the road and grass verge which form the boundary of the site. The southern portion of the site is approximately 1.5 to 2m above the adjacent site which is presumed to be the original ground level. A slope from the original ground surface at the southern boundary of the site up to the current site level is presumed to consist of made ground.

The shallow soils, recorded as possible made ground or reworked materials were the main focus of the Dames and Moore Phase 1 & 2 Investigations undertaken in 1999 which penetrated to depths of between 1 and 3.9m bgl. The overburden material was described as loose brown sandy gravelly Clay [topsoil] to a maximum depth of 1.5m and as silty gravelly Clay to 3.9m bgl. The investigation locations included two boreholes either side of the proposed extension and five boreholes on an adjacent unused site to the south of the main facility. Environmental laboratory testing undertaken on samples recovered indicated there was no contamination of the shallow made ground or sub soils exceeding the established criteria at the time of the investigation. Metal shavings and an elevated Total Petroleum Hydrocarbon (TPH) reading were detected in a BH to the south of the main facility on an adjacent site, outside of the current main facility site

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boundary. The conclusions of the Dames and Moore report states that the results from this borehole indicate that the contamination has not migrated below 1m bgl.

Glacial Deposits Cohesive Glacial deposits were recorded in each of the ground investigations undertaken in the area of the Industrial Estate beneath the existing topsoil or made ground layers present on the various sites. An upper and a lower till are apparent within the logs, differentiated by the strength description ranges of soft – firm and firm – very stiff. The depth of the soft – firm glacial deposits was recorded to typical depths of between 0m and 1.7m bgl. Occasionally firm – stiff glacial deposits were present beneath the topsoil or made ground layers. The typical depth of the firm – stiff cohesive glacial till was between 0.3m and 3.2m bgl. None of the boreholes reviewed penetrated deeper than 6m bgl, each terminating within the stiff glacial till, on boulder obstructions or possible bedrock. The description of both glacial deposits recorded on the logs was generally of sandy gravelly Clay or Clay/Silt with cobbles and boulders. In one cable percussion borehole, contained within the investigation of the Bruss site, 250m to the north east of the proposed extension, a compact coarse sandy Gravel, slightly claybound with cobbles and boulders was described from 4.4m to 5.8m bgl, at which point the borehole was terminated.

Bedrock The GSI solid geology (1:100,000) map sheet 7: Geology of Sligo – Leitrim, 1996 indicates that the site is underlain by dark Carboniferous Limestone/Shale of the Glencar formation. None of the boreholes provided by the GSI provided details relating to the type of rock beneath the site, however the depth to possible rock can be inferred from the termination depths noted on the logs. These depths ranged from 4.2m to 6.0m bgl.

Geological Heritage Sites and Resources The location of the proposed extension is not within any of the geological heritage sites listed in Appendix D of the 2005 – 2011 Sligo County Development Plan. The scale and location of the proposed extension adjacent to the existing facility and within the confines of the IDA park mean that the likely impact on potential geological heritage sites not yet identified is low.

9.1.5 Impacts

The construction activities associated with the proposed extension will involve the clearance of the existing hard-standing and made ground to expose a suitable formation layer. Foundations are likely to consist of reinforced concrete shallow strip and pad foundations or concrete piles to support the superstructure and internal fittings, plant and machinery. Graded granular material will be imported to provide granular fill below the underside of the floor slab, to provide a suitable foundation or capping layer for access roads and to backfill excavation for services

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and drainage. The excavated soil will be, where possible, reused on site in landscaping bunds to avoid disposal off site. The impact of these construction activities are summarised below in terms of construction impacts and impacts during the operational phase. Construction Phase Impacts The impacts on the soils and geology during the construction of the proposed extension are summarised below;

• Excavations on site will increase the area of superficial material exposed

(including stockpiles) which could result in an increased amount of fine material in the rainfall runoff which could eventually be discharged to local watercourses;

• Material accumulations such as building materials are often stored in outdoor stockpiles. Rainwater can percolate through stockpiles and have the potential to produce leachate which may contaminate the soil;

• Soil will be disturbed and eroded by vehicular activity during the construction phase and may generate dust. Construction traffic may transport soil from exposed surfaces or stockpiles onto local roads;

• A small proportion of excavated material may not be suitable for use as fill within the proposed extension and will need to be disposed off site to a suitably licensed facility;

• There is a potential for leakage or spillage of construction related materials on site affecting soil. These include leaks or spills of fuel from vehicles or temporary storage tanks, spills of raw or uncured concrete and grouts, wash down water from exposed aggregate surfaces, cast-in-place concrete from concrete trucks, fuels, lubricants and hydraulic fluids for equipment used on the proposed extension site, bitumen and sealants used for waterproofing concrete surfaces; and

• There will be a requirement for engineering fill to be used in the construction works. It is envisaged that the material used will be imported engineering fill and will be sourced from outside of the site in local quarries.

The location of the proposed extension is not expected to impact upon any geological resources present beneath the site. No active quarries or mineral resources are identified on the GSI public viewer maps in the area of the proposed extension, the nearest identified point of interest on the GSI Mineral Localities and Quarries (Active 2001) layers are approximately 3km to the west and south west of the Finiskilin area. The scale and location of the proposed extension adjacent to the existing facility and within the confines of the IDA park mean that the likely impact on potential resource sites not yet identified is low. Operational Phase Impacts During the operational phase of the proposed extension, the likely impacts on the soil and geology are described below:

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• Soil contamination could result from leakage of drainage or sewerage pipes due to ground settlement, movement or poor construction;

• Possible soil contamination from the storage of vehicle or machinery fuel and lubrication oils may occur if not appropriately managed;

• The soils and groundwater are at risk from contamination from the leakage of process effluent prior to discharge to the main IDA sewer from the holding tank in the area of the proposed extension. This leakage could be caused by excessive ground settlement, movement or damage during construction of the existing storage tank and;

• The soil and groundwater within and around the proposed extension may be at risk of contamination, during both construction and operation, from road salting, accidents, chemical and residue spillages and fire water contamination.

“Do nothing” impact The ‘Do-nothing’ impact would mean that the geology of the area is likely to be unaltered from its current state with the land remaining as an area of hard standing adjacent to the main facility.

9.1.6 Mitigation

This section describes a range of recommendations and mitigation measures designed to avoid, reduce or offset any of the adverse impacts predicted. Construction Phase Mitigation The mitigation measures during the construction phase for the predicated impacts on the soils and geology are summarised below;

• Earthworks operations shall be carried out such that surfaces as they are

being raised shall be designed with adequate falls, profiling and drainage to promote safe run-off and prevent ponding and flooding. Run-off will be controlled through silt/sediment traps as appropriate to minimise the turbidity of water in outfall areas. Care will be taken to allow that the bank surfaces are stable to minimise erosion.

• Subject to appropriate control and testing, spoil derived from excavation for the proposed extension could be re-used as engineering fill where required for roadways and other structures. The geotechnical properties of this fill would require assessment to determine it’s suitability for such use. This will minimise the requirement to import fill material to site.

• Pollution will be minimised by the implementation of good construction practices. Such practices will include adequate bunding for oil containers, wheel washers and dust suppression on site roads, and regular plant maintenance. The Construction Industry Research and Information Association (CIRIA) provides guidance on the control and management of water pollution from construction sites in their publication “Control of Water Pollution from Construction Sites, Guidance for Consultants and Contractors (Masters-Williams et al, 2001)”. This document will be utilised on site;

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• A contingency plan for pollution emergencies will also be developed by the appointed Contractor prior to work and regularly updated, which would identify the actions to be taken in the event of a pollution incident.

• Best practice construction techniques will be implemented in re-working any excavated material to minimize dust generation, groundwater infiltration and generation of runoff. Construction and demolition waste encountered in reworking this material will be disposed of, if appropriate, off site in accordance with the requirements of the Waste Management Acts, 1996 and 2001.

• Oil storage tanks will be bunded appropriately. Smaller quantities of hydrocarbon substances will be stored in suitable, secure buildings or enclosures with an impermeable floor surface;

• Appropriate measures will be put in place to minimise the risk of soil contamination from re-fuelling of vehicles, e.g., re-fuelling to be undertaken in designated areas with drained hard standing, and spill kits in place;

• Good housekeeping (daily site clean-ups, use of disposal bins, etc.) on the project site, and the proper use, storage and disposal of many substances used on construction sites, such as lubricants, fuels and oils and their containers will be implemented to mitigate against soil contamination; and

• Site specific target levels (SSTLs) will be identified for the soils to be retained within the site that are protective of all human/environmental receptors. Only soils with concentrations below these target levels will be retained on site within the landscaped areas.

Operational Phase Mitigation During the operational phase of the proposed extension, the mitigation measures for the predicated impacts on the soils and geology are summarised below:

• Sewer and drainage connections will not be damaged if designed constructed

using appropriate skill and care. The relevant design codes and construction supervision will be employed to ensure the connections are sufficiently robust and completed to the appropriate standards.

• In most cases, good housekeeping (daily site clean-ups, use of disposal bins, etc.) on the project site, and the proper use, storage and disposal of lubricants, fuels and oils, detergents and other chemicals harmful to the environment and their containers can mitigate against soil contamination.

• Oil storage tanks, if located within the area of the proposed extension, will be sited on bunded hard standing. Smaller quantities of potentially harmful substances will be stored in suitable, secure areas with an impermeable floor surface. Oil interceptors will be installed to intercept spillages of fuel which may occur outside of the bunded area.

9.1.7 Residual Impacts

If the recommended mitigation measures are adhered to, there will be no significant residual negative impacts on the soil and geology.

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There will be a certain amount of material excavated as a result of the proposed extension. It is anticipated that this material will be used as far as possible within the site boundaries to facilitate other elements of the proposed extension, such as landscaping and bunding.

9.1.8 Conclusions

A summary of the key finding is as follows:

• The excavation of both overburden soil and rock will present a number of potential environmental impacts. All mitigation measures noted in this report should be adhered to in full; and

• Material not suitable for re-use on site should be disposed of at a suitable licensed landfill facility. The requirements of the Waste Management Acts, 1996 and 2001 should be adhered to.

9.2 Hydrogeology

9.2.1 Introduction

This section of the EIS addresses the potential hydrogeology impacts that may result from the proposed development. It assesses the potential impacts of the proposed development on groundwater as a resource and pathway and where practicable, outlines measures for avoiding or mitigating these impacts. Groundwater plays an important part in determining the environmental characteristics of a region. Groundwater provides baseflow to local waterways and is linked to many elements of the regional ecosystem, and where redirections in the quality or quantity of groundwater would lead to an unacceptable impact on these receptors, mitigative actions will be required to reduce the impacts to acceptable levels.

9.2.2 Methodology

The hydrogeological site assessment was initially undertaken by conducting desk-top research of available data. The main sources of information used in the study included:

• “Geology in Environmental Impact Statements - A Guide”, Institute of Geologists Ireland (IGI), September, 2002.

• Website of the Geographical Survey of Ireland (www.gsi.ie) • Website of the Environmental Protection Agency (www.epa.ie) • Website of the National Parks and Wildlife Service (www.npws.ie)

The study area for the hydrogeological assessment extends approximately 3 km radially outward from the proposed development site.

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9.2.3 Relevant Legislation

As part of the EU Water Framework Directive groundwater has been characterised and an aquifer map of Ireland has been produced by the GSI (www.gsi.ie). These maps were reviewed and risks accessed using guidance produced by the Institute of Geologists of Ireland, “Geology in Environmental Impact Statements – a Guide”, (2002), in conjunction with further guidance produced by GSI (Groundwater Protection Scheme Guidelines, www.gsi.ie.)

9.2.4 Existing Hydrogeological Environment

The proposed extension is located within the Drumcliff-Strandhill Groundwater Body (GWB: IE WE G 0076). Under the Western River Basin District (RBD) Groundwater Action Programme (WFD, 2010) the Cummeen Strand/Drumcliff Bay SAC is a Groundwater Dependent Terrestrial Ecosystem (GWDTE) linked to the Drumcliff-Strandhill GWB. Under this action plan the Cummeen Strand / Drumcliff Bay (Sligo Bay) SAC GWDTE is currently classed as good but is at risk due to:

• Diffuse pressures from the urban risk; and • Groundwater quality risk.

Ground Water Distribution At the time of writing, geotechnical site investigation data for the proposed extension site was not available. The reviewed information indicates that water levels are across the Drumcliff-Strandhill GWB are 0 – 5m below ground. The average groundwater table encountered during the Ground Investigation (GI), referred to in Section 9.1 was 3mbgl. Bedrock Aquifer The proposed extension is located on a locally important aquifer, moderately productive only in local zones (LI) as categorised by the GSI. See EIS Volume 3: Drawings, Figure 9.3.

Under the GSI aquifer classification these types of aquifers (LI) have a limited and relatively poorly connected network of fractures, fissures and joints, giving a low fissure permeability which tends to decrease further with depth. A shallow zone of higher permeability may exist within the top few metres of more fractured/weathered rock, and higher permeability may also occur along fault zones. In general, the lack of connection between the limited fissures results in relatively poor aquifer storage and flow paths that may only extend a few hundred metres. Due to their low permeability and poor storage capacity, the aquifer has a low ‘recharge acceptance’. There were no direct measurements of permeability testing completed during the site investigations.

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Groundwater Flow There is no groundwater flow data available as the Geotechnical investigation at the site has not been carried. The GSI Drumcliff-Strandhill Ground Water Body Description (GSI, 2004) which encompasses the proposed development site states that the flow paths within this aquifer are relatively short and are likely to be up to 300 m in part. The description states that flow direction typically toward the coastline, which would suggest a north or north easterly flow direction. Groundwater Quality A Groundwater Protection Scheme is currently being prepared for County Sligo by the Geological Survey of Ireland. The overall aim of this scheme will be to preserve the quality of groundwater in County Sligo, particularly for drinking water purposes, for the benefit of present and future generations. Local Groundwater Use Based on information from the Geological Survey of Ireland (GSI) published database there are no registered borehole abstractions within 3km of the site. The closest recorded borehole is approximately 4.5km south west of the site. It should be noted that it is not mandatory to register details of wells in Ireland, and it therefore remains possible that not all wells in the area have been registered. A groundwater ”spring” is identified as being present approximately 2 km southwest of the site at Tobernaveen (www.gsi.ie). The yield class of the spring is classified as Intermediate, with a yield of 1,120m3/day. As regional groundwater flow follows the topography of the land, and flows towards the coast the spring has not been further evaluated. Groundwater Vulnerability Based on their Interim classification scheme, the GSI has classified the proposed extension site and the surrounding area as having a High vulnerability of the groundwater to pollution (GSI Interim classification – July 2010). See EIS Volume 3: Drawings, Figure 9.4. In addition to the GSI information, the site specific vulnerability based on known geological and hydrological conditions from the desk study has also been assessed. The vulnerability of groundwater to pollution is assessed using a matrix developed by the GSI (refer to Table 9.2.1) primarily for bedrock and gravel aquifers, and is mainly a function of the thickness and permeability of the sub-soils and the depth to underlying water-table(s). Thick, unsaturated sub-soils can mitigate the impact of potential pollutants by acting as a protective, filtering layer attenuating any infiltrating contaminants before they reach the groundwater.

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Table 9.2.1: GSI Matrix relating to Vulnerability of Groundwater to Pollution

As discussed in the Soils and Geology Chapter 9.1, the interpreted ground profile contains a sub soil of Glacial Till with a thickness of >6m. although the vulnerability is based on a thickness of 6m, bedrock was not encountered in any of the site investigations reviewed and referenced as no boreholes penetrated deeper that 6mbgl are available for review. The Draft Drumcliff-Strandhill Groundwater Body Description (August 2004) indicates that a bedrock thickness greater than 10m are recorded in the lower lying areas. This greater thickness would afford a higher level of protection to the groundwater/aquifer at the site. On this basis, using the vulnerability assessment matrix, and assuming a Low permeability of the glacial till deposits, the groundwater is considered to have Moderate vulnerability.

9.2.5 Potential Impacts Impact Assessment Framework In accordance with the GSI (2002) guidance, the environmental impacts that may result from the proposed development, during both the construction and operational phases, are assessed in the following sections. The assessment of the sensitivity of the groundwater is made according to the criteria set out and defined in Table 9.2.2. The magnitude of possible/predicted impacts on groundwater was based on the criteria defined in Table 9.2.3 and the combination of sensitivity and magnitude are used to derive the impact significance as detailed in Table 9.2.4.

Geological/Hydrogeological Characteristics Subsoil Permeability (Type) and Thickness Unsaturated

Zone Recharge Type

High permeability (sand /gravel)

Moderate Permeability (sandy till)

Low Permeability (clayey till, clay, peat)

(sand and gravel aquifers only)

Vulnerability Rating

0-3.0m 0-3.0m 0-3.0m 0-3.0m point (>30m radius)

Extreme

>3.0 3.0-10.0m 3.0-5.0m >3.0m diffuse High N/A >10m 5.0-10.0m N/A diffuse Moderate N/A N/A >10.0m N/A diffuse Low Notes: i) N/A = not applicable ii) Release point of contaminants is assumed to be 1-2 m below ground surface

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Groundwater Sensitivity Assessment The criteria used to assess the sensitivity of the groundwater based on these two potential roles are set out in Table 9.2.2 below.

Table 9.2.2: Sensitivity Criteria - Groundwater

Sensitivity Hydrogeological Description High Local groundwater aquifer(s) constitutes a valuable resource because of

its high quality and yield (>100 m3/d), or extensive exploitation for public, private domestic, agricultural and/or industrial supply. Aquifers classified as Regionally Important or Locally Important. Designated sites of nature conservation dependent on groundwater i.e. SAC or SPA. Aquifer is in hydraulic contact with a locally sensitive surface water resource e.g. used for drinking water, and is capable of discharging significant (>10 m3/day) volumes to this receptor.

Medium Local aquifer(s) of limited value because quality does not allow potable or other quality sensitive uses, or because available yields are limited (<100 m3/d). Exploitation of local groundwater is not extensive. Local areas of nature conservation known to be sensitive to groundwater impacts. Aquifer is in hydraulic contact with, but has limited recharge (<10m3/day) to, locally sensitive surface water or drinking water supplies.

Low Poor groundwater quality and/or very low permeabilities make exploitation of the aquifer(s) unfeasible. Changes to groundwater not expected to have an impact on local ecology. Aquifer is not in contact with sensitive receptors (e.g. exploitable drinking water supply).

The aquifer is moderately productive only in local zones and due to the low permeability and poor storage capacity, the aquifer is considered to have a low ‘recharge acceptance’. There is no known abstraction of groundwater from the bedrock aquifer for drinking water, private or public, or any industrial abstraction. The groundwater and surface water interactions for locally important, moderately productive aquifers involve groundwater discharging locally to streams and rivers crossing the aquifer and also to small springs and seeps. Owing to the poor productivity of the aquifers in this body it is unlikely that any major groundwater - surface water interactions occur. Baseflow to rivers and streams is likely to be relatively low and can significantly decrease in the drier summer months. The sensitivity of the groundwater is therefore assessed as being Medium.

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The magnitude (i.e. the severity of consequences) of each potential impact is assessed below in terms of whether they are likely to occur during construction and/or operational phases, using the criteria set out in Table 9.2.3.

Table 9.2.3.: Magnitude of Impact Criteria – Groundwater Magnitude

of Impacts

Description of Degree of Impact to Groundwater.

High Major permanent or long term change to groundwater quality. Existing significant resource use is irreparably impacted upon. Changes to quality or water table levels would have a major impact upon high sensitivity ecosystems or surface water resources (e.g. drinking water resource).

Medium Changes to the local groundwater regime are predicted to have a slight impact on resource use but not rule out any existing supplies. Changes to quality or water table levels would have a minor impact upon high sensitivity ecosystems or surface water resources (e.g. drinking water resource).

Low Changes to groundwater quality, levels or yields do not represent a risk to existing resource use or ecology.

Negligible Very slight change from groundwater baseline conditions approximating to a ‘no change’ situation.

Locally Important Aquifers (LI) are moderately productive, only in local zones and have a limited and relatively poorly connected network of fractures, fissures and joints. In general, the lack of connection between the limited fissures results in relatively poor aquifer storage and flow paths that may only extend a few hundred metres. The groundwater and surface water interactions for these types of aquifers involve groundwater discharging locally to streams and rivers crossing the aquifer and also to small springs and seeps. Owing to the poor productivity of the aquifers in this body it is unlikely that any major groundwater - surface water interactions occur. The magnitude of the impact is therefore assessed as being Low.

9.2.6 Assessment of Significance

In accordance with the GSI (2002) guidance, the assessment of the significance of the potential impacts is determined by matching the site sensitivity classification against the designated magnitude of impact, as set out in Table 9.2.4 below.

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Table 9.2.4: Assessment of Significance Criteria for Impacts on Hydrogeology

Magnitude of Impact Site Sensitivity High Medium Low Negligible High Substantial Substantial Moderate Slight Medium Moderate Moderate Slight Negligible Low Slight Negligible Negligible Negligible

Based on the above scheme, the assessed classification of the potential impact significance is provided in the following sections in terms of the various phases and proposed activities of the development. Do Nothing The current use of the site is industrial with large areas of hardstanding covering the site. Surface water runoff discharges to the local authority foul sewer. The magnitude of any impact to the hydrogeology due to ongoing industrial use is considered to be Negligible. As a result, the assessment of significance for the “Do Nothing” scenario is Negligible (Table 9.2.4). Construction Impacts on groundwater quality at the proposed extension may occur during construction as a result of pollution from contaminating substances used during construction such as concrete and fuels. There may be an indirect impact due to changes in physico-chemical composition of the groundwater. This would have a potential indirect impact on the Cummeen Strand/Drumcliff Bay SAC and Cummeen Strand SPA due to pollutants arising from construction. A variety of construction materials and chemical substances are likely to be used in the works, which could have various polluting potential if spilled adjacent to, or into, groundwater exposed during bulk excavations. Spillage of Hazardous Chemicals In the event of an accidental spillage of pollutants during construction activities, contamination may either migrate through the unsaturated zone or, if this has been removed during construction works, discharge directly to groundwater. However, in the event of a contamination spill during the construction phase, the magnitude of the impact is Medium due to the short flow paths, low permeability at depth and low base flow known for in this type of aquifer. Therefore the likelihood of a significant impact in with regard the aquifers resource potential and pathway is Moderate.

Temporary Dewatering The average groundwater table encountered during the Ground Investigation (GI) was 3mbgl, and so it may be anticipated that some local dewatering will be required during construction. Given the generally low permeability and consequent slow recharge of the drift deposits, dewatering is expected to generate a Negligible magnitude of impact in terms of the groundwater resources. Therefore, the significance of dewatering on the aquifer when considering groundwater as a

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resource is Negligible and when considering groundwater as a pathway is assessed as Slight.

Temporary Pooling Pooling and/or dispersion of greater amounts of surface water tend to occur during construction works. The presence of this excess surface water may increase infiltration into the upper groundwater table, thus increasing the groundwater flow rates for a limited period of time. The magnitude of this type of impact is considered to be Negligible, resulting in a maximum of Negligible overall significance of increased infiltration to the bedrock aquifer during construction.

Removal of Overburden The construction work will involve disturbance and removal of topsoil, made ground and subsoil (overburden). Site works will include clearance, and excavation of the proposed extension area. Given the current flat nature of the site and that the proposed finished levels will generally match that of the existing site levels excavation works are not anticipated to be significant and will be in the region of 3 mbgl. The proposed construction work will be undertaken over a 12-15 month period therefore, any impact will be temporary in nature. If a significant proportion of the glacial till overburden were to be removed or penetrated, there is the potential to expose the deeper groundwater to direct effects from construction activities, hydrocarbon leaks etc. The potential hazard increases where the overburden is thinnest or where the proportion of removal is greatest. Given the limited excavations and relatively shallow depth and the short-term nature and limited direct consequence of this potential impact, the magnitude of this type of impact is considered to be Low, resulting in a maximum of Slight overall significance of increased infiltration the aquifer during construction.

Loss of Aquifer Storage There are likely to be some locations in which excavations penetrate the water table. One consequence of this is that the aquifer’s capacity to store and slowly transmit water may be diminished. The magnitude of impact of this is considered to be Negligible. No loss of aquifer storage impacts in the lower aquifer would be expected, resulting in a Negligible impact in terms of both its resource and pathway values. Operation Leakage of Hazardous Chemicals It is anticipated that some hazardous materials will be used during the Stellamune production process. The magnitude of any leakage to ground is considered Medium. An impact significance of Moderate is assessed for the groundwater in terms of resource potential and Moderate in terms of its pathway value.

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However, any production spillages of hazardous materials occurring within the proposed extension will be contained and at worst discharged to local authority sewer through the process or foul water discharges.

Alterations of Existing Groundwater Regimes The proposed extension will have shallow foundations and which would not be expected to impact greatly on the groundwater regime. It is not envisaged that the proposed extension foundations will cause blockages of groundwater movement. Therefore the magnitude and significance are accessed as Negligible.

9.2.7 Mitigation

Construction Phase Mitigation The following mitigation measures will be implemented as a minimum during the construction stage to mitigate against impacts on the hydrogeology of the site and the Sligo Ground Water Body as a whole:

• To minimise any impact on the underlying subsurface strata from material

spillages, all oils, fuels, solvents and paints used during construction will be stored within specially constructed dedicated temporary bunded areas;

• Oil and fuel storage tank will be stored in these designated areas, when not in use and these areas shall be bunded to a volume of 110% of the capacity of the largest tank/container within the bunded area;

• Filling and draw-off points will be located entirely within the bunded area. Drainage from the bunded area shall be diverted for collection and safe disposal as required under the IPPC licence;

• Where possible refuelling of construction vehicles and the addition of hydraulic oils or lubricants to vehicles, will take place in a designated area of the site which will be away from surface water gulleys or drains;

• An adequate supply of spill kits and hydrocarbon adsorbent packs will be stored in the area;

• All relevant personnel will be fully trained in the use of this equipment. These measures will ensure that accidental inputs to and subsequent contamination of ground water and surface water do not occur during normal and or emergency conditions; and

• All waste management during the construction phase of the propsoed extension will be carried out in compliance with the requirements of the facilities IPPC Licence.

Operational Phase Mitigation The operational standard operating procedures (Refer to the Waste Management Section 15 for further details) will incorporate the correct handling and storage of potentially contaminating materials at the facility, and will go towards achieving full containment. The following measures will be implemented during operation:

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• All process/surface water from the operation of the proposed extension will be discharged to foul sewer in accordance with the conditions of the IPPC licence for the Elanco facility;

• There is no direct release of surface water from the facility to surface water bodies during construction or operation;

• Ultimate release of the water discharges from the Sligo Waste Water Treatment Plant to Slifo Bay will be under the conditions of EPA Waste Water Discharge License held by the WWTP;

• Pollution prevention requirements of the contractor have been proposed and these will reduce the risk of groundwater contamination as a result of construction works.


During construction and operation of the proposed extension, providing the afore mentioned mitigation measures will be implemented it is not considered that any residual impacts will remain, and therefore accessed as Negligible.

9.2.9 Conclusions

Table 9.2.5 below summarises the principal findings of this assessment in terms of potential impacts and the specific mitigation measures which will be used to ensure that the impacts do not occur. Table 9.2.5 Summarised Issues, Impacts and Specific Mitigation Measures

Impact on Groundwater

Issue Aquifer Sensitivity as resource / pathway

Magnitude Significance as resource / pathway

Proposed Mitigation

Accidental spillage of hazardous materials

Bedrock Medium Medium Moderate

Full containment of

hazardous materials, and surface water

runoff

Temporary dewatering

Bedrock Medium Negligible Negligible No specific mitigation required

Temporary pooling

Bedrock Medium Negligible Negligible No specific mitigation required

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Impact on Groundwater

Issue Aquifer Sensitivity as resource / pathway

Magnitude Significance as resource / pathway

Proposed Mitigation

Removal of Overburden

Bedrock Medium Low Slight No specific mitigation required

Loss or Aquifer Storage

Bedrock Medium Negligible Negligible

No specific mitigation required

Leakage of hazardous materials

Bedrock Medium Medium Moderate

Full containment of

hazardous materials, and surface water

runoff

Alterations to groundwater

regimes Bedrock Medium Negligible Negligible

No specific mitigation required

An assessment of potential sensitivities and significance of impact indicates that the proposed extension has the potential for moderate to negligible impacts due to spillages or leakage of hazardous materials. These risks will be mitigated through containment measures to be detailed in the Elanco standard Operating Procedures. All other identified risks to groundwater are considered to have acceptable significance of impacts, but nonetheless they will be also be mitigated through the measures detailed Section 9.2 7 – Mitigation Measures.

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10.0 NOISE & VIBRATION

10.1 Introduction This Section presents the findings of a noise and vibration assessment of the proposed extension development. To aid the understanding of this assessment definitions of some of the terms used are detailed in Appendix 10.1.

10.2 Methodology

10.2.1 Baseline Data Collection In order to give an indication of the existing noise climate, in the vicinity of the proposed extension, a noise survey was undertaken. Noise measurements were undertaken at each of the Elanco facilities located within the IDA Industrial Estate in June and July 2010. In addition, noise measurements were also undertaken at a location considered representative of the nearest noise sensitive receptors in June 2010. Refer to Volume 3, Figure 10.1 ‘Noise Monitoring Locations’,

10.2.2 Construction Noise and Vibration In assessing the potential noise and vibration impact at nearby sensitive receptors during construction, consideration has been given to the likely worst case phase of the construction works. Reference has been made to British Standard 5228: 2009 – Code of practice for noise and vibration control on construction and open sites – Part 1: Noise and Part 2: Vibration. BS 5228 provides information on the factors which affect the acceptability of site noise, guidance on the degree of noise control necessary and on possible mitigation measures.

10.2.3 Assumed Construction Activities At this stage, the exact construction schedule, and plant and equipment to be used, has not been finalised. However, consideration has been given to the likely plant and equipment that would be used during the likely worst case construction activity. A preliminary construction schedule has been produced, as such a typical worst case scenario has been assumed. The assessment looks at the ground works phase and includes plant typically associated with this activity. Details are given within Appendix 10.2

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10.2.4 Operational Noise and Vibration

The following noise sources will be introduced to the proposed extension: • Air Handling Units (AHU); • Chiller; • Condenser/ Refrigeration Units.

With regard to the proposed extension, all equipment, with the exception of 2 condensers, will be enclosed within the facility structure. The existing external equipment will remain in their current position and these operate on a 24 hours basis. Currently one AHU is located on the external façade under the footprint of the proposed extension. This AHU will be dismantled and another suitable location within the new building extension will be found. It should be noted that moving this noise source may affect the existing baseline noise climate, though within this report the impact of moving this item has been considered unlikely to alter any of the baseline noise levels and as such no further consideration is given to the impact of moving of this noise source.

10.2.5 Operational Noise Modelling Methodology

Noise levels at various receptor points associated with the proposed building extension have been predicted through the use of a computer based noise model. The CADNA-A Noise Modelling Software package used utilises the noise propagation algorithms within ISO 9613: Acoustics - Attenuation of sound during propagation outdoors for industrial noise sources. Free-field noise levels have been predicted. The noise model is considered representative of a typical daytime and night-time (operations are considered to be running 24hours a day), and includes all of the buildings within close vicinity of the proposed extension, each building is considered reflective. The ground is considered absorptive throughout the noise model and first order reflections are considered within the noise model. Details of the noise sources included within the computer model are detailed within appendix 10.3

10.2.6 Construction and Operational Road Traffic The construction and operation of the proposed extension is not anticipated to have a significant impact on traffic flows on any nearby roads. On this basis, it is considered that the traffic flows resulting from the proposed extension will not result in any perceptible noise changes at the nearest noise sensitive receptors.

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10.3 Legislation and Guidance

10.3.1 Construction Noise and Vibration BS 5228 In order to give an indication of the potential noise impact from construction activities, reference has been made to British Standard 5228: 2009 – Code of practice for noise and vibration control on construction and open sites – Part 1: Noise and Part 2: Vibration. BS 5228 provides information on the factors which affect the acceptability of site noise and the degree of control necessary. It also provides a methodology for the prediction of site noise at sensitive receptors and provides guidance on possible mitigation measures. NRA Guidance The National Roads Authority (NRA) publication entitled ‘Guidelines for the Treatment of Noise and Vibration in National Road Schemes’ (NRA, 2004) provides guidance on indicative limits for construction noise. Table 10.1 below provides the indicative noise limits typically deemed acceptable by local authorities. Table 10.1 Maximum Permissible Noise Levels at the Façade of Dwellings during Construction Days and Times

LAeq (1-hour) dB LAmax (slow) dB

Monday to Friday 07:00 – 19:00

70 80

Monday to Friday 19:00 – 22:00

60* 65*

Saturday 08:00 – 16:30

65 75

Sunday and Bank Holidays 08:00 – 16:30

60* 65*

Note* Construction activity at these times, other than that required in respect of emergency works, will normally

require the explicit permission of the relevant local authority

According to the NRA publication, there is no published Irish guidance relating to vibration during construction activities. Instead, common practice in Ireland has been to use guidance from internationally recognised standards. Vibration is typically expressed in terms of Peak Particle Velocity (PPV) in millimetres per second (mm/s) In the case of nominally continuous sources, such as road traffic, vibration is perceptible at around 0.5 mm/s, and may become disturbing or annoying at higher magnitudes. However, higher levels of vibration are typically tolerated for single events or events of short duration. For example, vibration levels up to 25 mm/s are typically tolerated for piling works. This guidance is only applicable to daytime

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activities as it is considered unreasonable to expect people to tolerate such activities during the night-time. Reference is made to BS 7385: 1993 - Evaluation and Measurement of Vibration in Buildings, Part 2: Guide to Damage Levels from Ground-borne Vibration and the German standard DIN4150 in determining appropriate limit values for vibration to minimise the risk of even cosmetic damage to buildings. The NRA limit values so that there is little or no risk of even cosmetic damage to buildings are presented in Table 10.2 below: Table 10.2 Allowable Vibration during Construction in order to minimise the Risk of Building Damage

Allowable vibration velocity (Peak Particle Velocity) at the closest part of any sensitive property to the source of vibration, at a frequency of Less than 10Hz 10 to 50Hz 50 to 100Hz(and above)

8mm/s 12.5mm/s 20mm/s

10.3.2 Operational Noise Environmental Protection Agency Integrated Pollution Prevention Control (IPPC) Licence – Reference Number P0090-01 The existing development is currently a regulated process under the IPPC legislation (now codified as Directive 2008/1/EC). The site is in possession of an IPPC licence (Reference Number P0090-01) which is granted by the Environmental Protection Agency (EPA). In accordance with the provisions and conditions of the licence, the “emissions from the activity shall not give rise to sound pressure levels (LAeq 15 minutes) at noise sensitive locations near the activity which exceed the limit values specified”. The limits specified in the licence are 55 dBA (Leq 15 minutes) during the daytime and 45 dBA (LAeq 15 minutes) during the night-time at the nearest noise sensitive location. Environmental Protection Agency Guidance The Environmental Protection Agency (EPA) provides guidance on appropriate noise limits for licensed facilities. The EPA document Entitled ‘Guidance Note for Noise in relation to Scheduled Activities’, 2nd Edition (2006) states that noise attributable to on-site activities should not generally exceed a free-field LAeq noise level of 55 dB by daytime (08:00 to 22:00) and a free-field LAeq noise level 45 dB by night-time (22:00 to 08:00), at any noise sensitive locations. These limits assume that the noise emissions are not tonal or impulsive. If the noise is tonal or impulsive there is a 5 dB penalty. These limits will be considered against likely operational noise levels.

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It should also be noted that, although the above limits are given within the EPA document, the EPA’s preferred method of assessing the likelihood of noise complaint is broadly in line with the BS 4142 (1997) assessment procedure, which is detailed below and has been included within this assessment. BS 4142: 1997 Assessment The likelihood of complaints about noise from industrial establishments, made by persons living in the vicinity, is assessed using the procedures laid out in BS 4142: 1997, Method for Rating Industrial Noise Affecting Mixed Residential and Industrial Areas. A comparison is made between the noise attributable to the proposed extension, expressed as LAeq (defined in BS 4142 as the ‘specific noise’), adjusted to take into account of tonal or impulsive characteristics (‘rating level’), and the existing background noise level expressed as LA90. Where the characteristics of the operational noise are such that it tends to attract attention (i.e. tonal or impulsive noise), a +5 dB correction is made in the assessment. The British Standard states, “A difference of around +10 dB or more indicates that complaints are likely. A difference of around +5 dB is of marginal significance. If the rating level is more than 10 dB below the measured background noise level this is a “positive indication that complaints are unlikely”. This Standard is generally used by Local Authorities in determining acceptable noise levels.

10.4 Description of Existing Environment The proposed extension is situated within the Finisklin Industrial Estate, Finisklin, west of Sligo city and west of the N4 Sligo Inner Relief Road. The site is immediately surrounded by a mainly industrial environment with the more urban environs of Sligo City Centre located approximately 1.7km from the proposed extension. The main industrial properties surrounding the proposed extension include those from the healthcare, medical packaging, food storage and engineering background. The nearest residential properties are located approximately 0.22km south east of the proposed extension in the Rathedmond Estate. The Cummeen Strand /Drumcliff Bay (Sligo Bay) Special Area of Conservation lies approximately 0.7km to the north of the site.

10.5 Baseline Noise Survey Weekday baseline noise measurements are undertaken on a 3 yearly basis in accordance with the provisions of the Fort Dodge IPPC Licence. Data was gathered at measuring positions considered representative of the nearest noise sensitive receptors on the 8th and 9th June 2010, which is located as detailed in Table 10.3 below:

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Table 10.3 Baseline Noise Monitoring Locations

Co-ordinates (ITM) Measurement Location

Location Description xxxxxx yyyyyy

MP15 Residential Estate- Rathedmond 167426 336284

The noise measurement locations are presented in Volume 3, Figure 10.1 ‘Noise Monitoring Locations’.

10.5.1 Instrumentation Measurements were all undertaken using Type 1 precision grade instrumentation. The instruments were located in free field locations, with the microphone at a height of approximately 1.5 metres above ground level. Measurements were undertaken with due regard to BS 7445 Description and Measurement of Environmental Noise Part 1: 2003. The data collected included LAeq, LA90, LA10 and LA1 noise levels. Attended daytime and night-time noise monitoring was undertaken, consisting of 15 minute measurements at each location in turn. The survey was undertaken using a Pulsar Model 33 sound level meter mounted on a tripod. Each 15 minute measurement period is considered representative of an hourly period. Instrumentation was calibrated using an acoustic calibrator. Calibrations were undertaken at the start of the survey and checked at the end of each survey. There were no variations observed in the calibration

10.5.2 Baseline Noise Survey Details and Results Weather Conditions The weather conditions for the daytime measurements on the Tuesday 8th June 2010, at the commencement of the survey, were damp with light winds. These conditions remained largely unchanged throughout the survey other than an occasional light breeze that developed during the period. The wind speed was below 5m/s during the course of the measurement period. The weather conditions for the night-time measurements on Wednesday 9th June 2010 at the commencement of the survey were damp with light winds. These conditions remained largely unchanged throughout the survey other than an occasional light breeze and some light rain that developed during the period. The wind speed was below 5m/s during the course of the measurement period. Access was not available during the night-time survey to measurement positions 11-13 on the 9th June 2010. These surveys were undertaken on the 9th July 2010. The weather conditions were light rain during the monitoring period with a light breeze. The wind speed was below 5m/s during the course of the measurement period.

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10.5.3 Results Summary

The results of the daytime baseline survey are provided in Table 10.4 below: Table 10.4 Summary results of the daytime baseline noise survey

Noise Levels in dB

Measurement Position

Monitoring Reference Period LAeq LAmax LA1 LA10 LA90

Residential Estate- Rathedmond

MP15 17:04 - 17:19

45.5 72.3 53.7 47.4 41.1

The results of the baseline nighttime noise levels are provided in Table 10.5 below: Table 10.5 Summary results of the night-time baseline noise survey

Noise Levels in dB Measurement Position

Monitoring Reference Period LAeq LAmax LA1 LA10 LA90

Residential Estate- Rathedmond

MP15 04:29-04:44

48.6 68.9 58.6 51.4 40.6

Dominant Noise Sources Measurement Position 15 – Rathedmond Residential Estate No noise was noted from the IDA Industrial Estate at measurement position 15 during the daytime surveys. During the night-time survey, a slight humming from the general direction of the IDA Industrial Estate was noted. Noise sources noted during the daytime and night-time surveys were bird song and car movements within the estate. Discussions of Results Daytime and night-time LA90 noise levels remained fairly consistent at 41 dB(A) during both the daytime and night-time surveys, while LA10 levels were 48 dB(A) and 51 dB(A) for the daytime and night-time periods respectively and LAeq levels varied between 46 dB(A) and 49 dB(A) respectively.

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10.6 Impacts Construction activities can give rise to temporary elevated noise levels, which can be the cause of disturbance at nearby residences. During the operation of the proposed building extension there is the possibility of more prolonged increases levels of disturbance at the nearest noise sensitive properties.

10.6.1 Construction Phase Impacts Typical groundworks construction activities were considered within the construction noise assessment. A typical groundworks scenario is likely to include the use of the following items of plant; tracked excavators, articulated dump trucks, and vibratory compactors. The combined sound pressure level (LP) for these noise sources, at a distance of 10m, was calculated to be 85 dB(A), which equates to a noise level of 58 dB(A) at the nearest noise sensitive receptors at Rathedmond estate, when accounting for distance attenuation only. It should be noted that in practice additional noise reductions are likely to occur as a result of the presence of obstacles and screening between the noise sources and the residential receptors. A noise level of 58 dB(A) at the nearest noise sensitive properties is well below the maximum permissible noise level at the façade of dwellings, during construction, given by the NRA for construction during weekday daytime hours (70 dB(A)). Details of the noise levels associated with these items of plant are given in appendix 10.2. The location of the proposed extension is over 200m from the nearest sensitive properties. Based on this relatively large distance and the lack of piling operations during construction (which tend to be the main source of both noise and vibration during construction), it is not considered likely that significant levels of vibration will be generated during construction.

10.6.2 Operational Phase Impacts Noise

Table 10.6 below summarise the predicted noise impact of the proposed building extension at the nearest sensitive receptors location at Rathedmond Estate, and the other monitoring locations considered during the baseline noise survey. Table 10.6 Predicted Operational Noise Levels (Ground Floor Level)

Receptor Reference

Receptor Location Predicted Noise Levels (dBA)

MP 15 Residential Estate- Rathedmond 32.1 The predicted noise levels at the baseline noise receptor locations, associated with noise source being introduced with the proposed extension, vary between 18 and 52 dB(A).

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IPPC Licence Assessment The noise impact associated with the proposed extension, predicted at the nearest noise sensitive properties at Rathedmond Estate (MP15), are shown in tables 10.7 and 10.8, below. Table 10.7 Operational Daytime IPPC Licence Compliance Assessment

Table 10.8 Operational Night-time IPPC Licence Compliance Assessment

*

* Derived facility contribution taken from ‘Environmental Noise Measurements, Elanco Facility (August 2010)’

It should be noted that the derived existing facility night-time noise level was derived using a simple distance correction and does not include any correction for intervening screening between the Elanco facility and the Rathedmond estate. Tables 10.7 and 10.8 both demonstrate that the contribution of the noise sources associated with the proposed extension are not significant at the nearest sensitive properties. The resultant total noise levels have remained unchanged at 46 dB(A) and 45 dB(A), during the daytime and night-time periods respectively, and as such the limits detailed within the IPPC licence have not been exceeded. The noise sources are not considered likely to be either tonal or impulsive, and as such it is considered that the EPA Guideline values will not be exceeded. It has been considered, due to the fact that the noise sources are largely all internal, and that the predicted noise levels are likely to be imperceptible at the nearest sensitive receptors, that the proposed extension will not introduce a tonal or impulsive noise source to the existing noise climate. It should also be noted that the resultant total daytime and night-time noise levels are not predicted to exceed 50dB during the daytime and 45 dB at night, the WHO guideline levels to minimise the risk of sleep disturbance and the level to minimise the risk of moderate annoyance is outdoor living areas, respectively.

Receptor Location

Predicted Noise Level (LAeq)

Existing Ambient Noise Level (LAeq)

Anticipated Total Noise Level (LAeq)

Licence Limit Value (LAeq)

Difference

MP 15 32 46 46 55 9 lower than

limit

Receptor Location


Existing Ambient Noise Level (LAeq)

Derived Existing Facility Contribution Noise Level (LAeq)*

Anticipated Total Noise Level (LAeq)

Licence Limit Value (LAeq)

Difference

MP 15 32 49 45 45 45 0

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BS4142 Assessment Table 10.9 shows the BS4142 noise assessment for the proposed extension. It should be noted that the background noise level is that measured during the 2010 baseline noise survey and as such includes the noise associated with the operation of the existing Elanco Facility. Table 10.9 Operational Daytime and Night-time IBS4142 Assessment

Note: Background noise levels of 41 dB(A) were measured during both the daytime and night-time measurement

periods. The new building is not considered to be introducing tonal or impulsive noise sources, as such the

predicted noise level represents both the specific noise level and the rating level.

Table 10.9 demonstrates that the noise levels associated with the proposed extension are not likely to give rise to complaints, indeed the assessment shows that the noise level at the nearest noise sensitive receptor are predicted to be 14 dB below the level considered to be of marginal significance and just above the level at which there is a positive indication that complaints are unlikely. Vibration The location of the proposed extension is over 200m from the nearest sensitive properties. Based on this relatively large distance it is considered unlikely that vibration associated with the operation of the proposed extension will be significant at the nearby sensitive receptors at Rathedmond estate.

10.7 Mitigation

10.7.1 Construction Phase Mitigation All construction work would be undertaken to the guidance in British Standard 5228: 2009 – Code of practice for noise and vibration control on construction and open sites – Part 1: Noise and Part 2: Vibration. It is considered unlikely that the noise and vibration levels generated during construction will result in significant impacts or exceed any limits imposed by the Local Authority at nearby noise sensitive receptors. As such, it is considered that no specific mitigation measures are likely to be required during the construction phase.

Receptor Location


Existing Background Noise Level (LA90)

Difference Assessment

MP 15 32 41 -9 Less than marginal situation

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10.7.2 Operational Phase Mitigation The noise assessment has demonstrated that the noise impact of the proposed extension is unlikely to result in a breach of the IPPC licence limits for both the daytime and night-time periods. No specific noise mitigation measures have been specified within the noise modelling exercise, indeed no attenuation at the AHU inlet and exhaust louvers has been applied. The proposed extension has been assumed to be constructed entirely from ‘Kingspan Louvre Panel Complete Wall & Façade System’ which has a Sound Reduction Index (SRI) spectrum as shown below: Table 10.10 Significance of Night-time Operational Levels

Wi With the exception of the level of sound reduction required for the main building, Table 10.10 above, no specific noise control measures have been specified. No noise attenuation at the louvers has been included within the noise model.

10.8 Residual Impacts

10.8.1 Construction A residual noise and vibration impact is not anticipated, as a consequence of construction activities, at the nearest sensitive properties to the proposed extension.

10.8.2 Operation Operational noise associated with the proposed extension is not considered to contribute perceptibly to noise levels currently experienced at nearby residential properties. As such, it is anticipated that the proposed extension overall will not result in an adverse noise impact.

10.9 Conclusions • The noise and vibration impact at nearby sensitive properties is considered

unlikely to be significant during the construction phase, and as such no specific noise control measures have been specified.

• The noise impact at nearby noise sensitive properties, during operation, is likely to be within the IPPC licence limits, indeed the noise associated with the proposed extension is considered unlikely to be perceptible at nearby noise sensitive properties.

Frequency (Hz)

63 125 250 500 1k 2k 4k 8k

SRI dB 20 15 17 23 18 25 40 46

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• The likelihood of noise complaint during daytime and night-time operation is considered small, with the noise assessment demonstration a ‘less than marginal’ situation.

• Given the significant distance to nearby sensitive receptors and the lack of significant vibration sources on-site, vibration is not considered to be an issue for either construction or operation of the proposed extension.

• Overall, the potential adverse noise impact from the proposed extension is considered to be slight.

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11.0 AIR QUALITY AND CLIMATE

11.1 Introduction

This Section presents the findings of an air quality impact assessment of the proposed extension at the Elanco production facility in Sligo. The proposed development site is situated within the Finisklin Industrial Estate, Finisklin, west of Sligo city and west of the N4 Sligo Inner Relief Road. The Cummeen Strand /Drumcliff Bay (Sligo Bay) Special Area of Conservation (SAC) and the Cummeen Strand Special Protection Area (SPA) lies approximately 0.5km to the north east of the proposed development site. The nearest residential properties are located approximately 220m south east of the proposed extension in the Rathedmond Estate. The proposed development site within the environs of the industrial estate, is immediately surrounded by a number of industrial properties including those from the healthcare, medical packaging, food storage and engineering background. The proposed year of opening for the extension is 2012, with peak operation expected shortly after opening. The proposed development site will be accessed through the existing entrance into the Elanco production facility. The existing development is currently a regulated process under the Integrated Pollution Prevention and Control legislation (now codified as Directive 2008/1/EC). The site is in possession of an Integrated Pollution Prevention and Control licence (Reference Number P0090-01) which is granted by the Environmental Protection Agency (EPA). In agreement with the EPA, the current IPPC licence will be amended to include the proposed extension. As such, its operation is not permitted to cause any significant harm to the environment. In accordance with the provisions and limits identified in the IPPC licence, the existing production facility monitors for the biological agents and for TA Luft Class III Organics from three specified monitoring points. The main sources of air pollution in the vicinity of the proposed extension are vehicular emissions from traffic accessing the estate. Given the nature of the industrial operations present within the estate, it is not considered that they would be a significant source of air pollutants and as such the background air quality is considered to be good in the context of the European Air Quality Standards (AQS).

11.2 Methodology

11.2.1 Overview The purpose of this work is to assess the impact of the proposed extension on air quality.

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The assessment must identify and quantify any potential significant impacts at the planning stage and recommend mitigation measures so that any impacts can be avoided or minimised. The method includes an assessment of available baseline air quality against the relevant air quality standards for the suitability of the proposed development site for its proposed use. Desk-based research into pollution measurements in the vicinity of the proposed development site, supplemented with indicative pollution measurements around the proposed development site are used to determine the baseline air quality. Consideration is made of the significant sources of air pollution in the area and any local effects that they may have. The baseline air quality is assessed for air pollutants likely to be present in significant quantities around the proposed development site that fall under legislative control. From the baseline air quality, an assessment is made of the ‘headroom’ between the baseline and the air quality standards. The ‘headroom’ can be used to assess the risk of the impact of the development causing exceedences of the air quality standards, at the proposed development site or in its vicinity. The mitigation measures, which are implemented are part of the process operations, are reviewed and an assessment of the likely residual impact is made.

11.2.2 Traffic Emissions The operation of the proposed extension will not have an impact on traffic flows on the nearby roads. A maximum of 10 - 15 additional staff will be employed at the facility. Existing deliveries will continue to the production facility, with a potentially slight increase to accommodate the requirements of the extended production facility. On this basis, it is considered that the traffic flows resulting from the proposed extension will not result in increased emissions to air, with any impact being negligible with no significant effect.

11.2.3 Fixed Emissions Sources As an element of the process operations, high efficiency particulate absorbing (HEPA) filters are currently operating for the existing facility and will be operated to minimise the release of any emissions to air from the proposed extension. The existing emission points will not be affected by the proposed extension and will remain in place. Up to 12 new emission points will be developed with HEPA filters in the new extension. Similar to the existing operations, the HEPA filters will be designed and operated to prevent the emission of biological agents.

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The monitoring undertaken for the IPPC licence for the facility shows that the HEPA filters are effective in preventing the emission of biological agents from the facility. On this basis is not considered that the proposed extension will result in any emissions of biological agents. As for the main process emissions points, a prohibition on the presence of Production Biological Agents is applied and monitored under the IPPC licence for the facility. This prohibition covers the presence of bacteria, virus or Genetically Modified Organisms which are used in the processes. TA Luft Class III Organics, a group of organic compounds defined as pollutants under German legislation, have potential carcinogenic effects. Their concentrations in air are not regulated under the Air Quality Standards Regulations with the exception of benzene, however are monitored at the Elanco facility under the requirements of the EPA IPPC licence which will be extended to included emissions from the proposed extension.

11.2.4 Impact Significance The method for assessing the significance of the predicted impacts is described below. The sensitivity of the receptors has been classified following the principles of health protection as referred to in the Air Quality Standards Regulations 2002 (‘the Regulations’), whereby a scientific risk-based approach is used to protect the population. Table 11.1 Sensitivity Criteria for Receptors

Sensitivity Description

High Receptors with people who are particularly sensitive to air pollution, including hospitals, retirement homes and schools.

Medium Moderately sensitive receptors where all population groups are present, such as residential areas and offices.

Low Receptors where only working population groups are present, for some of the time. These include farmland and industrial areas and ecological receptors.

The Regulations set out standards for the same pollutant which are higher for short periods and lower for longer periods. The objectives use concentrations which are derived from those shown to have adverse effects in the scientific literature, incorporating a margin of safety (Table 10.4). Locations where there is a low level of exposure of the general public (as opposed to the working population) relative to the relevant objectives are assigned a low sensitivity. These are shown in Table 11.1.

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The impact magnitude criteria use readily understandable adjectives to convey the meaning of air quality statistics to a non-technical reader (Table 11.2). A similar subjective assessment of the hazard combined with the probability of air pollution exposure is used to define the significance criteria (Table 11.3).

Table 11.2 Magnitude Criteria

Magnitude Air pollutants regulated under the Air Quality Standards Regulations 2002

High The predicted number of exceedences of a relevant air quality standard is greater than that set out in the Regulations

Medium Predicted concentrations would occasionally exceed relevant Air Quality Standards

Low Predicted concentrations are less than relevant Air Quality Standards

Negligible Change would not be readily detected using current measurement techniques

Table 11.3 Significance Criteria

Sensitivity Magnitude Low Medium High

High Moderate Moderate/Major Major Medium Minor/Moderate Moderate Moderate/ Major Low Minor Minor Minor/ Moderate Negligible

No Significant Effect No Significant Effect /Minor

Minor/No significant effect

Whether the impact is beneficial or adverse depends on the direction of change in level of the air pollutant in question.

11.2.5 Legislation The European Union issues Directives for the control of ambient air pollution, industrial pollution and trans-boundary pollution. Irish Regulations put these Directives into force in Ireland. Ambient air quality is regulated by setting standards or limits for common pollutants. Regulations may set lower limits than in the Directive.

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Up to 1996, separate Directives were issued for the control of air pollution parameters such as Directive 80/779/EEC of 1980 on air quality limits values and guide values for sulphur dioxide and suspended particulates. The 1996 Framework Directive on air quality established a structure for the long term control of air pollution. Subsequent "daughter" Directives set ambient air quality standards for 12 pollutants. The first two of those have been adopted. These control particulates, nitrogen oxides, sulphur dioxide, lead, benzene and carbon monoxide. These have been transcribed into Irish Regulations (S.I No 271 of 2002). The first daughter directive (1999/30/EC) relates to limit values for sulphur dioxide, nitrogen dioxide and oxides of nitrogen, particulate matter and lead in air. The second daughter directive (2000/69/EC) relates to limit values for benzene and carbon monoxide in ambient air. The third Directive controlling ozone has been published (2002/3/EC). Since ozone is a largely trans-boundary air pollutant it is beyond the control of local government to manage its concentration. In 2008, Directive 2008/50/EC was published, which supersedes the foregoing Directives. It has yet to be transposed into Irish law. The Directive drops provisional tighter limits for PM10 and introduces a limit value for a smaller size fraction of particulate matter, PM2.5. Pollution from industrial plant and processes is regulated under the Protection of the Environment Act 2003 (S.I. No. 27 of 2003) which sets into Irish law Council Directive 96/61/EC concerning Integrated Pollution Prevention and Control (IPPC Directive and subsequent amendments – these are now codified in Directive 2008/1/EC). Operators permitted under the system should be prevented from causing harm to the environment and from allowing emissions from their operations to cause exceedences of the air quality standards. The regulations are enforced by the EPA.

11.2.6 Air Quality Standards The Air Quality Standards set out by the EU have been adopted under Irish regulation in the form of the Air Quality Standards Regulations 2002 (SI 271) and a summary of these are presented in Table 11.4 below. Stage 2 limits for PM10 will not be retained since they have been dropped from the 2008 EU Directive, and are not shown.

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Table 11.4 Relevant Air Quality Standards

Objective Pollutant Concentration Measured as

Date to be achieved by

Benzene 5 �g/m3 Annual mean 1 January 2010 200 �g/m3 not to be exceeded more than 18 times a year

1 hour mean 1 January 2010 Nitrogen Dioxide (NO2)

40 �g/m3 Annual mean 1 January 2010 Nitrogen Oxides (NOx)

30 �g/m3 Annual Mean* 17 June 2002

350 �g/m3 Hourly Mean 1 January 2005 125 �g/m3 24 hour mean

Sulphur Dioxide (SO2)

20 �g/m3 Annual Mean* 17 June 2002 50 �g/m3 not to be exceeded more than 35 times a year

24 hour mean 1 January 2005 Particulates (PM10) Stage 1 (2005)

40 �g/m3 Annual mean 1 January 2005 Carbon Monoxide (CO)

10 mg/m3 Running 8 hour mean

1 January 2005

Lead (Pb) 0.5 �g/m3 Annual Mean 1 January 2005

* for the protection of vegetation and ecosystems (this does not apply in industrial areas) Where limits are set for the prevention of harm to health, averaging periods are laid out based on medical evidence as to the periods over which harm has been shown to occur and the technical practicalities of pollution measurement. Air pollutants can be separated into ‘primary’ and ‘secondary’ pollutants. ‘Primary’ pollutants are emitted directly to the atmosphere, and ‘secondary’ pollutants are formed by reactions in the atmosphere. Some pollutants including nitrogen dioxide and PM10 particulate matter are formed from both ‘primary’ and ‘secondary’ components. Benzene and lead are primary pollutants and are emitted in the greater part from cars; emissions and thus ambient concentrations have been controlled by the reduction or replacement of the quantities of these pollutants in petrol. Sulphur dioxide (SO2) emissions and the resulting airborne concentrations arise from the combustion of fuels containing sulphur. Sulphur dioxide concentrations have been brought down by limiting of sulphur content of diesel and reduction in the use of coal for domestic heating. Carbon monoxide (CO) is emitted as a result of the incomplete oxidation of fuel. Emissions of carbon monoxide from cars have been much reduced by the introduction of three-way catalysts to the car fleet.

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Nitrogen oxides (NOx) are comprised of nitrogen dioxide and nitric oxide which are emitted from the combination of nitrogen and oxygen in reactions during combustion. The actual concentration of nitrogen dioxide (NO2) in the atmosphere is mainly influenced by the reaction of nitric oxide (NO) with ozone, and it is mainly a secondary pollutant. Particulate matter (PM10) is emitted as soot during incomplete combustion of fuels, is formed in the air from the reactions of other pollutants, and arises naturally from the Earth’s crustal matter (dust) and sea-salt. PM10 particulate matter may reach the level set in the short term standard, particularly as a result of polluted air being blown on easterly winds from Britain and the continent. Concentrations of ambient lead, benzene, sulphur dioxide and carbon monoxide tend to be well within the standards set down. Levels of ozone have been largely exceeding the standards set down in the EU Daughter Directive in continental Europe and southern Britain. It is a secondary, transboundary air pollutant so it is beyond the control of local governments to manage its concentration at a local level. It is not considered in this assessment. As discussed in section 11.2.3, the TA Luft Class III Organics, and the biological agents are not regulated under the Air Quality Standards Regulations 2002, with the exception of benzene. However, they are considered pollutants and monitored under emissions to atmosphere in accordance with the IPPC licence for the facility.

11.3 Description of the Existing Environment The proposed development site is situated within the Finisklin Industrial Estate, Finisklin, west of Sligo city and west of the N4 Sligo Inner Relief Road. The proposed development site is immediately surrounded by a mainly industrial environment with the more urban environs of Sligo City Centre located approximately 1.7km from the site. The main industrial properties surrounding the proposed extension include those from the healthcare, medical packaging, food storage and engineering background. The nearest residential properties are located approximately 220m south east of the proposed extension in the Rathedmond Estate. The Cummeen Strand /Drumcliff Bay (Sligo Bay) Special Area of Conservation and The Cummeen Strand Special Protection Area lies approximately 0.5km to the north east of the proposed development site.

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11.3.1 Sources of Information Under the provisions of EU Directive 96/62/EC, there is a requirement for air quality measurements to be made at appropriate locations to establish the air quality environment across national regions. An ambient air monitoring programme was undertaken in Sligo City in 2003. Use has also been made of relevant reports, listed below:

• Ambient Air Monitoring in Sligo 20th January 2003 – 2nd October 2003 – Environmental Protection Agency

• Air Quality in Ireland 2008 - Environmental Protection Agency. • Elanco AER

In addition, diffusion tubes to measure nitrogen dioxide (NO2) were deployed around the proposed development site, as a check against the baseline. These measurements are indicative of the annual mean concentration. The locations chosen for measurements are depicted in Figure 11.1, Volume 3. ‘Air Monitoring locations’.

11.3.2 Sources of Air Pollution The principal sources of air pollutants in the subject area are emissions from road traffic, domestic heating and cooking and industrial activities. Given the absence of major ‘heavy’ industry in the area, the sources of air pollution are relatively limited. Roadside pollutant levels adjacent to the N4 Inner Sligo Relief Road and adjacent regional roads may be elevated in comparison to pollutant levels elsewhere. Given the sources of air pollution described above, it is expected that the Air Quality Standards would be met in the vicinity of the proposed development site.

11.3.3 Air Quality at the Elanco Facility In accordance with the provision of the IPPC licence, the existing facility is required to monitor air emissions from the existing production facility from 3 emission points. The 2009 Annual Environmental Report (AER) for the Elanco facility, which was submitted to the EPA, indicates that monthly monitoring is undertaken to verify the absence of biological agents from the production facility and that no biological agents were detected in the air emissions samples taken during 2009 and 2008. The 2009 AER indicates air emissions are also monitored on a quarterly basis for TA Luft Class III Organics. A summary of the quantities of TA Luft Class III Organics emitted in 2008 and 2009 is outlined in the table below:

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Table 11.5 TA Luft Class III Organics Mass Emissions 2008 & 2009

Parameter – TA Luft Class III Organics

Mass Emissions (Kg) - 2008

Mass Emissions (Kg) - 2009

IPPC Licensed Emissions (Kg)

Emission Point A 14 2 5548 Emission Point B 328 252 3650 Emission Point C 13 7 8322

A reduction in the level of mass emissions of TA Luft Class III Organics results from a decrease in the volume of a solvent called Isoproponal which is used in the operation for swabbing of work surfaces, and cleaning of containers. It’s expected that the 2010 emission levels for TA Luft Class III Organics will be in the region of those presented for 2009. The proposed extension will not result in the additional emissions of TA Luft Class III Organics or other chemical substances to the air.

11.3.4 Diffusion Tube Monitoring in the Vicinity of the Proposed Extension A survey of nitrogen dioxide concentrations was carried out in the vicinity of the proposed development site for a period of 1 month, using diffusion tubes in a range of background and roadside locations. The measurements obtained are indicative and comparable to the Air Quality Standards annual mean concentration. Figure 11.1, Volume 3, ‘Air Monitoring locations’ depicts the diffusion tube locations. The results are tabulated below: Table 11.6 Nitrogen dioxide monitoring locations and concentrations

NO2 ug/m3 Receptor ID Location Type x y

June-July 2010

Rathedmond Estate Western Boundary (E1)

Residential 567928 836279 2.34

Rathedmond Estate Southern Boundary (E2a )

Residential 568049 836123 3.13

Rathedmond Estate Southern Boundary (E2b )

Residential 568049 836123 3.23

Rathedmond Estate Eastern Boundary (E3 )

Residential 568223 836187 2.90

St Colms – on Roadside (No. E4a)

Roadside 567996 836632 9.50

St Colms – on Roadside Roadside 567996 836632 8.83

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(No. E4b) St.Colms – Northern Boundary (No. E5)

Background 568006 836686 3.19

SS Building – on Roadside (No. E6)

Roadside 567825 836601 7.91

Production Facility - North West Corner – (No. E7)

Background 567708 836562 Missing*

Production Facility – South West Corner – (No. E8)

Background 567682 836465 Missing*

Production Facility – Southern Boundary (No. E9)

Background 567781 836465 3.40

Production Facility – Eastern Boundary – (No. E10a)

Background 567815 836520 3.42

Production Facility – Eastern Boundary – (No. E10b)

Background 567815 836520 3.04

Production Facility – North East Corner – (No. E11)

Background 567815 836579 3.92

Quality Control Facility – Roadside (No. E12)

Roadside 567675 836348 3.42

Quality Control Facility –South West boundary (No. E13a)

Background 567662 836278 2.29

Quality Control Facility –South West boundary (No. E13b)

Background 567662 836278 2.04

*Diffusion tubes could not be located as a result of removal and replacement of the existing boundary fence on

which the tubes were located.

The indicative diffusion tube results are all well below 40 �g/m3, the Air Quality Standards annual mean value for nitrogen dioxide.

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11.3.5 Air Quality in Sligo City Air quality information has been taken from the Ambient Air Monitoring in Sligo 20th January 2003 – 2nd October 2003 Report. The EPA monitoring station was located in the carpark of Sligo General Hospital which is approximately 2.0km from the proposed development site and which was located in a largely residential area. Data from the report has been reviewed and the pollutant measurements outlined below.

Table 11.7 Air Quality Measurements in Sligo, 2003

Parameter Unit Result

Carbon Monoxide Maximum 8 hours Mean in mg.m3 1.6 Sulphur Dioxide Mean Hourly Value - ug.m-3 11.0 Sulphur Dioxide Maximum 24 Hour Value - ug.m-3 37.4 Nitrogen Dioxide Mean Hourly Limit- ug.m-3 11.7 Nitrogen Dioxide Maximum Hourly Limit - ug.m-3 245 Oxide of Nitrogen Mean Hourly Value - ug.m-3 NO2 18.7 Particulate Matter

(PM10) Mean Daily Value - ug.m-3 17.7

Benzene Mean Hourly Value - ug.m-3 0.4 Lead Concentration of Pb - ug.m-3 0.01

With regards to Carbon Monoxide, there were no exceedances of the AQS standards for this parameter. The AQS limits for sulphur dioxide were not exceeded with the exception of the 20 ug.m-3 limit for the protection of ecosystems. However, this limit is not deemed relevant to air quality monitoring in an urban area. There were 2 exceedances of the limit value for nitrogen dioxide. However, 18 exceedances are necessary in a calendar year for a location to be defined as above a limit value. The limit value for PM10 was exceeded on 7 days during the monitoring period. However, 35 exceedances are necessary in a calendar year for a location to be defined as above a limit value. There were no exceedances of lead or benzene during the monitoring period.

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11.3.6 Air Quality in Ireland 2008 Under the provisions of EU Directive 96/62/EC, each country should be divided into zones. Any monitoring, assessment and reporting of air quality is then undertaken based on these zones. Sligo city has been categorised as Zone C which is defined as a “specified population centres >15,000 inhabitants”. The extent of monitoring in any zone is determined by the population status and the air quality status. No monitoring has been undertaken by the EPA in Sligo since 2003. The Environmental Protection Agency report on Air Quality in Ireland 2008, reports that no standards for PM10, SO2, annual NO2, hourly and long term ozone, lead, CO and benzene were exceeded within the Zone C areas.

11.3.7 Climate Change – Greenhouse Gases Combustion of fossil fuels for energy purposes is the greatest source of greenhouse gases (GHGs) in Ireland, representing 95% of CO2 emissions and 63% of total emissions. The largest share of emissions resulting from the production of energy is from the energy industry (25% of total emissions) and from transport (17%). Transport is likely to contribute around 19% of GHG emissions by 2010 without measures to reduce GHG emissions (DoEHLG 2004).

11.3.8 Summary of Background Air Quality The available data suggests that the air quality in the vicinity of the proposed extension falls well within EU limits at receptor locations. On the basis the information presented, there appears to be significant ‘headroom’ between the background air quality and the Air Quality Standards, such that the proposed extension would be unlikely to threaten breaches of those standards at locations of relevant public exposure. In terms of background air quality, the proposed development site is considered to be suitable for a development of this nature.

11.4 Impacts

Impacts of the proposed extension on the surrounding environment will be different at the construction and operation phases. Construction on the scale proposed can give rise to fugitive dust emissions, which can be the cause of nuisance at nearby residences. On operation, the proposed extension will increase emissions to atmosphere from process emissions however will be mitigated through the use of HEPA filters. As outlined above, the traffic flows resulting from the proposed extension will not result in significantly increased emissions to air.

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The nearest residential properties, the Rathedmond Estate, is located approximately 0.22km from the boundary of the proposed development site.

11.4.1 Construction Phase Impacts The construction phase of the proposed extension will have a duration of 12 months with a peak of 40-50 personnel including management and supervision staff. The construction phase may result in fugitive dust emissions and vehicle exhaust emissions from construction vehicles. Such emissions are generally variable in nature, and their potential impact is primarily dependent on the extent and type of construction activity, ground conditions and weather conditions at the time. In terms of health impacts, the most significant portion of particulate matter is that which is smaller than 10 microns in diameter (PM10). Fugitive dust created from construction activities is generally of significantly greater diameter, and has less potential to cause adverse health impacts. The larger dust particles generated during construction tend to be deposited within 200m of their emission point. Consequently, because of the nature of the emissions, any potential impacts are most likely to be related to nuisance dust deposition in the immediate vicinity of the proposed development site rather than ambient air quality (PM10) concerns. The nearest sensitive receptor is located approximately 0.22km from the proposed development site boundary at the Rathedmond Estate. Industries in the vicinity include Abbott Ireland and Stiefel Laboratories Ireland. The specific details of these operations are not known. However, the production process at these facilities may take place in clean room conditions (with minimised airborne particulate matter) and/or may require an air intake point. Given appropriate mitigation measures, it would not be expected that construction would give rise to fugitive dust sufficient to affect the operations at these facilities or the residential receptors at Rathedmond. For the construction phase, the only potential air quality issue is the potential nuisance from fugitive dust emissions. There will be GHG emissions to the atmosphere during the construction of the proposed extension. Construction Plant will give rise to emissions such as C02 and Nitrogen Dioxide (NO2).

11.4.2 Operational Phase Impacts Anticipated air quality impacts during the operational phase of the proposed extension will be as a result of additional traffic arising from the development. PM10 and NO2 are the two most significant pollutants potentially arising from traffic emissions. During the opening year 2014, the proposed extension is likely to give

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rise to a maximum 10 - 15 additional staff vehicles per weekday and a limited number of additional deliveries. In terms of air quality, this may result in a minor rise in air pollutants in the immediate vicinity of the road into the proposed development site. Given the current air quality and minor increase in additional traffic accessing the proposed development site during the operational phase, the traffic impact from the proposed extension will therefore have no significant effect and the resulting pollutant concentrations are expected to fall well within the Air Quality Standards. The proposed extension will also require additional energy for the production process. Given the minor increase in additional energy required at the proposed extension for the operational phase, the impact from the proposed extension is considered to have no significant effect on climate change and the resulting pollutant concentrations are expected to fall well within the Air Quality Standards. As there are no odour releasing issues with any of the materials used in the process and the proposed extension will have a closed system it is expected that there will be a negligible release of odour to the environment.

11.4.3 Do Nothing If the proposed extension does not take place, it is envisaged that the air quality in the vicinity would remain at the current level.

11.4.4 Impact Significance Assessment The receptors are considered to be of “medium sensitivity” with any increase in pollution considered to be negligible in magnitude as they would be below the current AQS and any change would not be readily detected. Overall, in terms of air quality, it is considered that the proposed extension will have no significant effect in terms of increases in pollutant levels in the vicinity of the proposed development site.

11.5 Mitigation

11.5.1 Construction Phase Mitigation The only likely air quality impact during construction will be the generation of fugitive dust. In order to mitigate any potential emissions arising from fugitive dust during the construction phase, (and hence minimise potential impacts), a ‘Contractors’ Code of Conduct for the Control of Fugitive Dust’ will be developed in consultation with the Local Planning Authority, to avoid, reduce and remedy significant adverse impacts on air quality. Typical elements of such a code are set out in Appendix 11.1 and could be used during construction of the proposed extension.

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Mitigation measures to reduce climate change emissions other than normal engine maintenance by the contractor and their plant will not be required during the construction phase.

11.5.2 Operational Phase Mitigation There will be no additional generator type equipment being for the proposed extension installed, as it is anticipated that capacity of the equipment from the existing facility will be used. In general terms, both climate change and health impact air pollutant emissions from the proposed extension will be reduced approximately in relation to the reduction of the use of fossil fuels to provide energy. The greatest contribution to mitigating the energy consumption of the proposed extension will rely on the extension design and construction. The technologies selected to provide its energy requirements will determine the actual emissions of health impact air pollutants.


11.6.1 Construction With appropriate mitigation in place and given the distance and sensitivity of the residential receptors to the proposed development site, the residual impact of this aspect is considered to be negligible.

11.6.2 Operation The residual effect of the health impact air pollutants emitted as a consequence of the proposed extension is likely to be minor negative at worst as regards the receptors in the vicinity of the proposed development site.

11.7 Conclusions The key findings of the assessment are summarised below:

• Air quality in the vicinity is good relative to EU Standards. • Fugitive dust may cause local nuisance during construction but this will be

mitigated by good construction practice. In any event, the impact will be temporary in nature.

• Given the extent of the proposed extension, the increase in air pollutants as a consequence will have a minor negative effect at worst (during operation) on air quality in the vicinity of the proposed development site.

• 12 additional emission points to air will be added in the extension, which will be served with HEPA filters. Based on monitoring evidence, these will give rise to no significant emissions of biological agents. Therefore the impact of

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the fixed plant emissions on air quality in the vicinity of the proposed development site is likely to have no significant effect.

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12.0 LANDSCAPE AND VISUAL

12.1 Introduction

This section assesses the effects of the proposed extension on the landscape and visual environment. Landscape has two separate but closely related aspects. The first is visual impact; that is the extent to which a proposed development can be seen in the landscape. The second is impact on landscape character; that is the impact that a proposed development may have on the fabric of the landscape. Landscape character is defined as the distinct and recognisable pattern of elements that occur consistently in a particular area. This draws on the appearance of the land; including shape, form and colour, and their particular interactions to create specific images and patterns distinctive to particular localities – in other words to create a ‘sense of place’.

12.2 Methodology

12.2.1 General

Both desktop and site visits were undertaken in the landscape and visual assessment. The desk study allowed for the identification of the relevant landscape and visual designations and guidance policy relating to the local and wider landscape context. The baseline assessment included a review of national and local development plans and relevant documents in order to consider the likely impact of the proposed extension within the context of existing landscape policy for the area. A list of baseline reference documents is provided in Section 12.10. The desk study also included a review of ordnance survey mapping, aerial photography and site plans, together with plans, sections and elevations of the proposed extension. In addition, various local information sources, including internet-based resources, were consulted in the course of the assessment. Other sections of this EIS were also reviewed providing contextual information for this section of the EIS. Site visits were undertaken during June 2010. This involved roadside surveys of the wider setting, together with a walking survey of the existing facilities occupied by Elanco within the Finisklin Industrial Estate and immediate areas in the vicinity of the site.

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12.2.2 Assessment Methodology

The assessment methodology has regard to advice notes and guidelines for landscape and visual assessment as set out in the following documents:

• Advice notes on current practice in the preparation of Environmental Impact

Statements, (EPA, 2003); • Guidelines on information to be contained in Environmental Impact

Statements, (EPA, 2003); and • Guidelines for Landscape and Visual Impact Assessment 2nd Edition,

(IEMA/LI, 2002).

In carrying out the landscape and visual assessment the baseline study of the receiving landscape describes:

• The landscape planning context, including any special values that may apply,

e.g. regional or local landscape designations; • The landscape character, including patterns and scale of landform, land

cover, land use and built development; • The visual landscape, including location of visual receptors; and • In summary, the significance and sensitivity of the landscape and visual

environment.

The effects of the proposed extension on the receiving landscape and visual environment are assessed and impacts described in terms of their significance as described under assessment criteria identified below. In the assessment, landscape impacts are defined as:

• direct effects upon specific landscape elements; • changes in the fabric, character and quality of the landscape; • effects on the overall pattern of landscape, regional and local distinctiveness;

and • effects on designated landscapes, amenity and conservation areas.

Visual impacts are considered in viewer groups and defined as:

• direct effects on views; • effects on viewers, properties; and • effects on visual amenity.

Measures which aim to avoid, reduce and remediate significant impacts are described where appropriate under Mitigation Measures and any remaining significant impacts are noted under Residual Impacts.

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12.2.3 Sensitivity and Significance Assessment Criteria

The construction of the proposed extension and any associated works will give rise to effects on the landscape and visual environment, which are assessed in terms of sensitivity, magnitude and significance levels, details of which are outlined below. Sensitivity Assessment The sensitivity criteria used for this landscape assessment are formed from guidance given in The Guidelines for Landscape and Visual Impact Assessment 2nd Edition (IEMA/LI, 2002). The sensitivity of a landscape is defined as: “the extent to which a landscape can accept change of a particular type and scale without unacceptable adverse effects on its character” (LVIA guidelines). The sensitivity of a landscape receptor is therefore based on its character and quality. The sensitivity criteria for proposed extension are negligible, low, medium, high and very high. Magnitude Assessment The magnitude of an effect is described as the size, extent and duration of an effect on landscape elements, character or visual receptors. The magnitude criteria for the proposed extension are no change, negligible, minor, moderate and major

Significance Assessment The significance criteria used for the landscape and visual impact assessment are given in the Guidelines on the information to be contained in Environmental Impact Statements (EPA, 2002). The significance criteria for the proposed extension are imperceptible, slight, moderate, significant and profound. For full details on the methodology, please refer to Appendix 12.1.

12.2.4 3D Visuals

A number of 3D visualisations of the location, layout and structural detail of the proposed extension have been developed and are presented in Figures 12.1-12.8.

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12.3 Landscape Planning Context

The proposed extension is to be located on lands within the boundary of the existing Elanco production facility located at the Finisklin Industrial Estate, Sligo City, Co. Sligo. The lands are industrial in use. The boundary of the site is defined predominantly by other industrial activities which form part of the industrial estate and also the Finisklin Road located along the western and northern boundaries. The sectors of industrial activities located in the vicinity include those from the healthcare, medical packaging, food storage and engineering backgrounds. The site is located north west of Sligo City Centre and west of the N4 Sligo Inner Relief road. The following provides a detailed overview of landscape objectives, policies, and strategies relevant to the site.

12.3.1 Landscape Planning: National and Regional

National Spatial Strategy for Ireland (NSS) (2002-2020) The NSS is a planning framework which is “designed to achieve a better balance of social, economic, physical development and population growth between regions” in Ireland. The NSS identifies Sligo City as an urban centre “to be developed in the manner of a Gateway City to drive the overall development of the North-West”. The NSS also identifies that to build on the potential national role of Sligo, a framework must be developed which will “utilize its substantial physical capacity for development, while safeguarding its outstanding natural setting”

National Development Plan -Transforming Ireland – A Better Quality of Life for All (NDP) (2007-2013) The NDP refers to the NSS and outlines that the development of the Gateway Cities will also result in growth in the wider regions of which the Gateway Cities (which includes Sligo) are an integral element. The NDP also identifies that growth and development must be undertaken in a manner which will “enhance and protect our natural environment”

Draft Regional Planning Guidelines 2010 – Border Region Authority The Border Regional Authority includes the geographical area of the counties of Cavan, Donegal, Leitrim, Louth, Monaghan and Sligo. The Guidelines are a long term strategic planning document which aims to direct the future growth of the Border Region, and also seek to implement the planning framework set out in the NSS.

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The Guidelines identify a number of key strategic goals (SG) which primarily relate to the sustainable development within the Border Region and which also includes the following:

• “SG5: To protect and enhance the quality of the natural environment and built

heritage of the Region” �

In addition, Section 6.4 of the Guidelines refer to landscape aspects and management of them within the Border Region. A Landscape Policy and Landscape Objectives have been developed for the Border Region and are detailed below:

�

• Landscape Policy

ENVP7 Protect and manage the landscape of the Region;

ENVP8 Local Authorities shall collaborate with adjoining planning authorities so that all development plan policies are consistent in the protection and management of landscape

• Landscape Strategic Objectives

ENVO6 “Adopt policies and measures in County Development Plans to protect, manage and plan landscapes through the provision of Landscape Classification and Character Assessments, in accordance with adopted European (and contemporary National) Landscape Guidance Documents such as ‘Guidelines for the Implementation of the European Landscape Convention, February 2008”

ENVO7 “Inclusion of policies in Development Plans to protect important views and prospects and special amenity areas to facilitate passive enjoyment of the heritage of the landscape.”

12.3.2 Landscape Planning: Sligo and Environs Development Plan (SEDP) 2010-2016 / Sligo County Development Plan 2005-2011

Strategic Environmental Issues - SEDP 2010-2016 Chapter 2 of the Sligo and Environs Plan identifies that the key strategic environmental issue for Sligo and the Environs is

• “the protection of archaeological heritage and sensitive landscape features”

Broad Aims (BA) - SEDP 2010-2016 With regards to environmental quality, the broad aims of the Sligo and Environs Plan identify the following:

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• BA3 –a –“Wisely conserve the natural and built heritage of Sligo City and the surrounding area, including the character of the landscape, views and prospects, and the environmental quality of the urban setting.”

• BA3 –c- “Protect the landscape character and ecological integrity of the coastal and lakeshore zone.”

Zoning – BITP: Business Industry and Technology Park – SEDP (2010-2016) The area of the proposed extension has been designated under “Business, Industry and Technology Park” in the Sligo and Environs Development Plan (2010-2016). The objective for this area is to “promote the development of office based businesses, technology companies and industrial units in dedicated business-industrial parks at Finisklin” Open Space Objectives - SEDP (2010-2016) The Sligo and Environs Development Plan (2010-2016) identifies 9 principal areas which shall be developed as part of the open space strategy. Two of the 9 principal areas are as follows: The O-OS-6 West: Gibraltar / Cumeen –Finisklin Docklands open space objective area is located approximately 0.7km from the proposed extension In addition, the O-OS-13 Gibraltar to Finisklin Green Corridor is located approximately 0.7km from the proposed extension. It is proposed that Sligo Borough will develop a linked green network which shall include each of the designated green corridors.

Landscape Assessment - Sligo County Development Plan (2005-2011) Although the location of the proposed extension is covered by the SEDP (2010-2016), the Sligo County Development Plan (2005-2011) also identifies a number of objectives with regards to the landscape assessment for County Sligo. These are as follows:

• “Seek to preserve the landscape character of County Sligo by assessing all

development proposals against the provisions of the Development Control Policy Map.

• Discourage any developments that would be detrimental to the unique visual character of designated Visually Vulnerable Areas.

• Strictly control new development in designated Sensitive Rural Landscapes, while considering exceptions that can demonstrate a clear need to locate in the area concerned.

• Ensure that any new development in designated Sensitive Rural Landscapes:

• does not impinge in any significant way on the character, integrity and distinctiveness of the area;

• does not detract from the scenic value of the area;

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• meets high standards of siting and design; • satisfies all other criteria with regard to, inter alia, servicing,

public safety and prevention of pollution.

• Preserve the scenic views listed in Appendix F (of the Development Plan) by controlling development along designated Scenic Routes and other roads, while facilitating developments that may be tied to a specific location or the demonstrated needs of applicants to reside in a particular area. In all cases, strict location, siting and design criteria shall apply, as set out in Section 9.”

The Sligo County Development Plan (2005-2011) does not identify the proposed extension to be located within any sensitive or visually vulnerable areas.

Trees and Hedgerows - Sligo County Development Plan (2005-2011) The Sligo County Development Plan (2005-2011) identifies that trees and hedgerows contribute significantly to biodiversity and landscape. The Plans objective with regards to trees and hedgerows is to:

• “Promote the protection of trees and hedgerows from development that would

impact adversely upon them, and the enhancement of existing hedgerows by seeking increased coverage, in conjunction with new development.”

There are no Tree Preservation Orders located in the vicinity of the proposed extension.

Protected Views and Scenic Routes- Sligo County Development Plan (2005-2011) The Sligo County Development Plan (2005-2011) identifies a number of scenic routes and protected views within County Sligo.

The proposed extension is not located in the vicinity of any protected views of scenic routes.

12.4 Existing Environment

The proposed extension is located within the Finisklin Industrial Estate which is approximately 1km from Sligo City. The area is characterised as an industrialised environment with a number of industrial and business premises located in the immediate vicinity. The main industrial properties surrounding the site include those from the healthcare, medical packaging, food storage and engineering background. Sligo City and the N4 Sligo Inner Relief Road lie to the south east and east of the site with the Finisklin Road which abounds the site directly on its northern and western boundaries. The closest residential development, the Rathedmond Estate, is located 0.22km in south easterly direction from the site.

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A green field site located to the south west of the site and consists of a managed grassland area bordered by planted trees. This area is considered to be of low ecological significance.

12.4.1 Landscape Description

The following provides a brief description of the landscape for the surrounding area. The Cummeen Strand /Drumcliff Bay (Sligo Bay) SAC/SPA and pNHA is located 0.7km to the north west of the site. The dominant habitats on this site are estuaries and intertidal sand and mud flats. The site encompasses the Sligo Harbour which receives the waters of the Garavogue River, which flows from Lough Gill where the River originates. Sligo City itself is surrounded by a mountainous skyline, with the ridges of Slieve Daeane and Killery Mountain to the south-east, Cope’s and Keelogyboy Mountains to the northeast, the Knocknarea Mountains to the west and Ben Bulben to the north. These mountains are visible from many locations throughout the city. The most notable heights within the Sligo City are Cairns Hill and the Green Fort, both containing archaeological remains. The closest site of architectural heritage is the Ursuline Convent located on the Finisklin Road which is approximately 1.1km from the proposed extension. The Convent is currently operated as a secondary school. In terms of archaeological heritage, 3 sites are located within 1km of the proposed extension with the closest located approximately 0.15km from the site boundary.

12.4.2 Viewer Groups Description

With the exception of some business/industrial premises within the immediate vicinity, there are no direct views into the site. The Elanco site itself is abounded by a palisade fence and neighbouring industrial operations directly on its eastern and south eastern boundaries. The Finisklin Road directly abounds the site on its northern and western boundaries. The adjacent green field site is located on the south western boundary of the site. The Rathedmond Estate located 0.22km from the site has no direct views into the Finisklin Industrial Estate or more specifically the existing Elanco site or site boundaries. The western boundary of the Rathedmond Estate is abounded by a 2-3m high wall and established conifer tree planting which currently screen any views into the Industrial Estate.

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12.4.3 Landscape and Viewer Group Sensitivity

All of the receptors identified below in Table 12.1 are considered to be of a particular landscape and visual sensitivity in terms of potential alteration or change of their current character and setting.

Table 12.1: Landscape & Visual Receptor Sensitivity

Landscape Receptors Sensitivity Justification

The general landscape fabric of the SAC/SPA area and proposed pNHA

Very High Internationally protected sites located within 1 km of the proposed extension

The green corridor and open space areas at the Gibraltar – Finisklin areas

High It is the objective of the Borough and County Councils under the SEDP 2010-2016 to develop this areas as part of the open space strategy

Setting of the Ursuline Convent which is a Recorded Protected Structure located on the Finisklin Road

High Nationally protected structure located within 1 km of the proposed extension

The setting of the 2no. fulacht fiadh sites in the townlands of Rathedmond and Knappagh More

Medium Nationally protected site located within 1 km of the proposed extension

The setting of a Ringfort site in Rathedmond townland

Medium Nationally protected site located within 1 km of the proposed extension

Access Roads within the Finisklin Business Park

Low Not an important landscape character feature

Visual Receptors Sensitivity Justification Residential properties at the Rathedmond Estate

High Residential receptors within 0.5 km of the proposed extension

Ursuline Convent High receptors within 0.5 km of the proposed extension

Current Business/Industrial Users of the Finisklin Business Park

Low Receptors not affected by change

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12.5 Characteristics of the Proposed Extension

The proposed extension is described in detail in Section 5 of this EIS. As such only a brief description of the proposed extension and its features are noted in the following section.

12.5.1 General Project Description The existing Elanco facility has been operating on the site in excess of 15 years and the proposed extension which is approximately 512m2 in area and 9m in height will be located within the boundaries of the existing production facility. This represent a circa 15% increase in footprint to the existing facility The Main Plant consists of the production building, a front and rear car park, an access road, a concrete yard area, dedicated emissions/waste management areas, a sprinkler holding tank, and small areas of landscaped grounds. The proposed extension will be adjacent to the existing Elanco production building and will share some of the functions of the existing facilities including, gowning rooms, warehousing, dispensary, media preparation, wash and sterilization and some utilities. The proposed extension will comprise a primary production area for fermentation and inactivation with its own personnel access and a secondary fill/finish facility which will be accessed from the existing main changing rooms.

12.6 Impacts

12.6.1 Introduction and Context

In terms of landscape and visual impacts, it is important to provide a level of project-related context that is considered to have a strong influence on the likely perception of these impacts. It is not considered that the proposed extension represents a significant development within the industrialised landscape of the estate. The design and layout of the proposed extension takes cognisance of the design of the existing facility and of its landscape setting within the industrial estate.

12.6.2 Do-nothing Scenario

Should the proposed extension not proceed, it is considered likely that the site will continue in its existing land use for the foreseeable future.

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12.6.3 Visual Impact

Construction Phase Impacts During the construction phase, the initial site earthworks phase will involve the removal and relocation of topsoil within the existing site boundary. Temporary construction works will include the provision of a temporary access road during construction phase into the site. This access road will be provided into the site on the northern boundary which currently abounds the Finisklin Road. Site offices will also be located within the existing site boundary. Off site car parking will be provided for construction site personnel. Temporary visual impacts will also arise from the operation and movement of heavy plant and equipment on site. It is considered that due to construction activity and the movement of construction traffic in the vicinity of the proposed extension, there will be short-term imperceptible-slight negative visual impacts upon the receptors in the immediate area i.e. the Finisklin Road and the existing business / industrial users. Taking into account the limited views into the site and also the distance from the proposed extension, it is considered that visual impact resulting from construction activities on the remaining receptors will be short-term and of imperceptible negative significance during the construction phase.

Operational Phase Impacts The proposed extension is designed to tie in closely with the existing Elanco facility to minimise the level of intrusion on the landscape. This provides a natural continuity in the built form of the existing facility and proposed extension. Due to the, distance from the proposed extension, the filtering/ screening effect of the site boundaries, intervening developments and the intervening trees and hedgerows in a flat landscape setting, the proposed extension will have little to no visual presence at the following receptors:

• SAC/SPA/pNHA Area; • Heritage Properties which includes the Fulacht Fiadh and the Ringfort Sites; • Recorded Protected Structure of the Ursuline Convent; and • Residential properties in particular the Rathedmond Estate

Although these receptors are considered to be of medium-very high in terms of sensitivity, the presence of the proposed extension will not result in a visual impact and therefore is not considered to impact on the landscape value or character of the receptors. In this regards, although the impact is permanent in duration, the significance of the impact is imperceptible at these receptors.

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The area surrounding the proposed extension predominantly consists of commercial and industrial sites and on this basis, the presence of the proposed extension will not result in a significant change to the existing character of the environment. On this basis, with regards to the Finisklin Road and the existing business/industrial users, the presence of the proposed extension is permanent in duration and the impact is imperceptible-slight negative in terms of significance.

12.6.4 Visual Impact at Night

In addition to the Finisklin Road which is illuminated at night, there are also elements of the existing production facility which are also illuminated at night including existing doorways and the access road into the site. The proposed extension will operate on a 24hour basis. There will be a slight increase in the level of general illumination within the area. However, it is not considered that any additional night-time illumination will be a significant feature of the proposed extension. The majority of the operations will be undertaken within the enclosed facility. It is not considered that the level of illumination will give rise to visual impact on any of the receptors identified above. On this basis, it is considered that the development of the proposed extension will result in a permanent imperceptible impact only, in terms of visual impact at night.

12.6.5 Impact on Landscape and Landscape Planning

The majority of the landscape planning objectives and policies relate to the protection and conservation of the landscape character and sensitive landscape features. It is considered that the proposed extension does not conflict with these policies as follows:

Draft Regional Planning Guidelines: ENVO6 Adopt policies and measures in County Development Plans to protect, manage and plan landscapes through the provision of Landscape Classification and Character Assessments, in accordance with adopted European (and contemporary National) Landscape Guidance Documents such as ‘Guidelines for the Implementation of the European Landscape Convention, February 2008’

Draft Regional Planning Guidelines: ENVO7 Inclusion of policies in Development Plans to protect important views and prospects and special amenity areas to facilitate passive enjoyment of the heritage of the landscape.”

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The proposed extension will be located within the Finisklin Industrial Estate and is enclosed within the boundaries of the existing production facility. This area has been specifically designated under “Business, Industry and Technology Park” in the Sligo and Environs Development Plan (2010-2016).

Sligo and Environs Development Plan (2010-2016): BA3 –a –“Wisely conserve the natural and built heritage of Sligo City and the surrounding area, including the character of the landscape, views and prospects, and the environmental quality of the urban setting.” Sligo and Environs Development Plan (2010-2016): BA3 –c- “Protect the landscape character and ecological integrity of the coastal and lakeshore zone.” Sligo County Development Plan (2005-2011): Seek to preserve the landscape character of County Sligo by assessing all development proposals against the provisions of the Development Control Policy Map.

It is clear from the location, nature, scale and setting of the proposed extension that the landscape character of Sligo City, the surrounding areas including the coastal and lakeshore areas will not be impacted. In addition, the proposed extension is not located in the vicinity of and will not impact on any protected views.

Sligo County Development Plan (2005-2011): Discourage any developments that would be detrimental to the unique visual character of designated Visually Vulnerable Areas. Strictly control new development in designated Sensitive Rural Landscapes, while considering exceptions that can demonstrate a clear need to locate in the area concerned. Preserve the scenic views listed in Appendix F (of the Development Plan) by controlling development along designated Scenic Routes and other roads, while facilitating developments that may be tied to a specific location or the demonstrated needs of applicants to reside in a particular area. In all cases, strict location, siting and design criteria shall apply, as set out in Section 9.”

The proposed extension is not located within and will not impact on any designated Visually Vulnerable Area or a Sensitive Rural Landscape as identified under the Sligo County Development Plan. The proposed extension will have no impact on and is not located in the vicinity of any scenic routes. In conclusion, having reviewed the extent of and the location of the proposed extension, within a designated business and technology zone, it is considered that it will have no impact on the landscape character or sensitive landscape features of Sligo City and County Sligo in an overall context.

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12.7 Mitigation

Mitigation for landscape and visual impact has been considered within the design and development of the proposed extension. There are no specific mitigation measures proposed to ameliorate the impacts on the landscape and visual environment. It is considered that the proposed extension has been organised in terms of design and layout to take cognisance of the design of the existing facility and of its setting within the industrial estate. The proposed extension is not considered significant in scale and there will be limited visibility into the site. In addition, as identified in the 3D visualisations in Appendix 12.1, height of the proposed extension and proposed cladding for the external façade will be similar to the green colour of the existing facility.


In terms of visual impact, the proposed extension will have a permanent imperceptible residual impact on its immediate surroundings. It is not considered that the development of the proposed extension will alter the visual context of or the landscape character of the surrounds of the Finisklin Industrial Estate. In terms of overall landscape planning and policy, it is considered that the proposed extension will have no impact on the landscape plans and objectives directly relating to Sligo City and County Sligo in an overall context.

12.9 Conclusions

There will be some visual impacts during the construction phase resulting from the; site earthworks phase and the operation and movement of heavy plant and equipment on site. These impacts will be short-term imperceptible-slight negative visual impacts upon the receptors in the immediate area. The landscape and visual receptors in the surrounding area are considered to be of medium-very high in terms of sensitivity. The operation of the proposed extension will not result in a visual impact and therefore is not considered to impact on the landscape value or character of the receptors. In this regards, although the impact is permanent in duration, the significance of the impact is imperceptible at these receptors. It is considered that the proposed extension does not conflict with Landscape Planning Policies particularly as the area has been specifically designated as “Business, Industry and Technology Park” in the Sligo and Environs Development Plan (2010-2016).

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Overall, based on the location, nature and setting of the proposed extension, it is considered that there will be no impacts in terms of landscape and imperceptible visual impacts. The proposed extension will be located within the boundaries of the existing production facility and it is not expected that the extension will significantly alter the existing landscape and visual context of the immediate surroundings. In addition, there will be limited visibility of the proposed extension.

12.10 Landscape Guidelines, Information and Policy Reference

The assessment has regard to the information as set out in the following documents:

• Landscape and Landscape Assessment – Consultation Draft Guidelines for

Planning Authorities, (Department of Environment and Local Government, 2000).

• Sligo County Development Plan 2005-2011 • Sligo and Environs Development Plan 2010-2016 • Draft Regional Planning Guidelines 2010 – Border Region Authority

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13.0 CULTURAL HERITAGE

13.1 Introduction

This section reports on the results of the archaeological and architectural heritage assessment and was prepared in accordance with the following documents:

• Guidelines on the information to be contained in Environmental Impact

Statements (EPA, 2002); • Advice Notes on Current Practice (in the preparation of Environmental Impact

Statements) (EPA, 2003); and • Guidelines for the Assessment of Archaeological Heritage Impacts of National

Road Schemes, (NRA, 2005a); • Guidelines for the Assessment of Architectural Heritage Impacts of National

Road Schemes, (NRA, 2005b); While this project is not a road scheme, the NRA Guidelines (2005a and 2005b) were used as they offer a best practice approach for the assessment of potential impacts on archaeological and architectural heritage.

13.2 Relevant Legislation and Policy Context

All archaeological sites are protected under the National Monuments Acts 1930 – 2004. The definition of a monument used in Section 2 of the Act includes in effect all man-made structures of whatever form or date except buildings habitually used for ecclesiastical purposes (Minister for Arts, Heritage, Gaeltacht and the Islands 1999, 36). In addition, Section 23 of the National Monuments (Amendment) Act 1930 requires that a person finding an archaeological object must not remove it or otherwise interfere with it unless they have reasonable cause to believe that it was necessary to remove it so as to preserve it or keep it safe. It is also required that the finder of such objects reports them to the Director of the National Museum of Ireland within 96 hours. Section 2(1) of the 1994 Act provides that for any archaeological object found which has no known owner, ownership is vested in the State. Section 12 (1) of the 1994 Act provides that a Record of Monuments and Places (RMP) shall be established. This is maintained by the department of the Environment, Heritage and Local Government. Under Section 12 of this Act any works in relation to a Recorded Monument requires two months notice to the Department of the Environment and Local Government. This includes Zones of Archaeological Potential in urban areas.

Under Section 26 of the 1930 National Monuments Act and Section 21 of the 1994 Act and subsequent amendments, all excavations undertaken for the purpose of finding archaeological remains, or prospection for archaeological purposes, require

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a licence from the National Monuments Service, acting on behalf of the Minister of the Environment, Heritage and Local Government. The Planning and Development Act 2000 also requires that a local authority set up and maintain a Record of Protected Structures which consists of structures that are of special archaeological, historical, archaeological, artistic, cultural, scientific, social or technical interest. Designation of a Protected Structure also confers protection on land and structures within the curtilage4 of the Protected Structure. Structures within this area are therefore subject to the same planning restrictions as the Protected Structure itself. Attendant grounds are defined by the Architectural Heritage Protection Guidelines for Planning Authorities 2004 as lands which lie outside the curtilage of a protected structure, but are intrinsic to its appreciation, function or setting (DEHLG 2004, 192). Features of importance within attendant grounds are not automatically protected as part of the curtilage of a Protected Structure and require specific inclusion in the Record of Protected Structures. National heritage policy is referenced and amplified in the Sligo and Environs Development Plan 2010-2016. The objective of Sligo Borough and County Councils relating specifically to Archaeological and Cultural Heritage are detailed within the Sligo and Environs Development Plan 2010-2016 under O-AH-1 to O-AH-7. Archaeological heritage policies are detailed under P-AH-1 to P-AH-11.

13.3 Methodology

13.3.1 Assessment methodology

A study area was defined extending 150m from the boundary of the proposed extension. For this study area data was gathered from the following sources of information:

• Record of Monuments and Places (RMP); • The Sligo and Environs Development Plan 2010-2016; • The Sligo County Development Plan 2005-2011; • National Inventory of Architectural Heritage (NIAH); • NIAH Survey of Historic Gardens and Designed Landscapes; • Historical mapping and historical aerial photographs available from www.osi.ie;

and • Database of Irish Excavation Reports (www.excavations.ie) and the published

Excavation Bulletins.

The significance of potential impacts was assessed based on the methodology outlined in Guidelines for the Assessment of Archaeological Heritage Impacts of

4 Curtilage is not defined in legislation, however, the Architectural Heritage Protection Guidelines for Planning Authorities states that it can be taken to mean the parcel of land immediately associated with the structure which is or was used for the purposes of the structure (2004, 13.1.1).

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National Road Schemes, (NRA, 2005a); and Guidelines for the Assessment of Architectural Heritage Impacts of National Road Schemes, (NRA, 2005b).

13.4 Archaeological Heritage

13.4.1 Description of the Existing Environment Only one site of archaeological importance has been identified within the study area (Site 1; see Figure 13.1). Located approximately 125m to the south-southwest of the proposed extension, this is the possible site of a fulacht fiadh5 shown on the 3rd edition of the Ordnance Survey 6” map (County Sligo Sheet 14). This site is a Recorded Monument (Reference No. SLO 14-061) and RMP records that while this area was once used as poorly drained pasture with a stream running by the site, it is now located in the Finisklin Industrial Estate and that much of the area has been levelled and built upon, the rest is landscaped and no trace of this site was visible. Two sites have been identified within 500m of the proposed extension (Sites 2 & 3; see Figure 13.1), comprising the possible sites of fulachta fiadh shown on the 3rd edition of the Ordnance Survey 6” map (County Sligo Sheet 14). These sites are also Recorded Monuments (Reference No. SLO 14-059 and SLO 14-060). The RMP records that while this area was once used as poorly drained pasture with a stream running by the site, it is now located in the Finisklin Industrial Estate and that much of the area has been levelled and built upon, the rest is landscaped and no trace of this site was visible. Testing and monitoring undertaken to the west of the development area identified no archaeological sites (Corcoran 2005a, 2005b; O’ Connell 2006a). In addition to the possible fulachta fiadh described above, the proposed extension is located close to the River Garavogue and Sligo Bay. A number of significant archaeological sites, mainly of prehistoric date, were excavated in advance of the N4 Sligo Inner Relief Road, located approximately 1 km to the south-east of the study area. The location of the proposed extension is shown as undeveloped on the first edition of the Ordnance Survey 6” map and 25” map (County Sligo Sheet 14). Evidence from these sources indicates that undeveloped (greenfield) areas could have high potential for the presence of unknown archaeological remains. However the area of the proposed extension has previously been developed and landscaped and is now an area of hardstanding. It is highly likely that this development has removed any surviving archaeological remains. The potential of development area for the presence of unidentified archaeological remains has been assessed as None.

5 While the majority of fulachta fiadh (also known as burnt mounds) have been dated to the Bronze Age, some examples have been dated to the Neolithic and medieval period. Fulacht fiadh usually consist of a U-shaped mound of burnt stone which is often associated with a water-filled trough. It is thought that the heated stones were added to the water in the trough to heat it, although for what purpose remains open to interpretation. The most popular suggestions are that they were used for cooking or as sweat lodges.

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Figure 13.1 Location of sites of Archaeological importance within 500m of the proposed extension (source; DEHLG National Monuments Section – Map Viewer)

13.4.2 Impacts

“Do Nothing” scenario Should the proposed extension not proceed the proposed development site will continue to form part of an industrial park. The magnitude of the do nothing impact on all the sites has been assessed as No Change and the significance of this impact has been assessed as None. Construction Phase Impacts No sites of archaeological importance have been identified within the area of the proposed development and former development is likely to have removed any unknown archaeological remains. Based on this no impacts during construction are predicted. Operational Phase Impacts No impacts during operation are predicted.

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13.4.3 Summary of Mitigation Measures

As no impacts are predicted, no archaeological mitigation is recommended.


Residual Effects can be considered as those that remain significant following the application of mitigation measures, although they are likely to have been reduced in magnitude as a result of mitigation. No impacts are predicted and the residual significance of impact has therefore been assessed as None.

13.4.5 Conclusions One site of archaeological importance has been identified within the study area. This is the possible site if a fulacht fiadh located 125m to the south-southwest of the proposed extension and is a Recorded Monument (Reference No. SLO14-061). The proposed extension will have not have an impact on this site. As the area of the proposed extension has previously been developed in the recent past, the potential of this area for unknown archaeological remains has been assessed to be none. No impacts during construction or operation are predicted. The residual significance of impact on all known sites is predicted to be none.

13.5 Architectural Heritage

13.5.1 Description of Existing Environment

Existing Environment of the Study Area One site of architectural heritage importance has been identified within the study area (Site 4; see Figure 13.2). This is the former site of a demesne associated with Farmhill House (now destroyed) shown on the first edition of the Ordnance Survey six inch map. This site has also been identified by the NIAH Survey of Historic Gardens and Designed Landscapes (Reference No. SL-25-G-675363), which states that “Virtually no recognisable features of this site survive”6. This site has been assessed to be of Local importance.

6 http://www.buildingsofireland.ie/cgi-bin/viewsite.cgi?siteid=4790

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Figure 13.2 Site 4 former site of a demesne associated with Farmhill House (now destroyed – area shaded in darker grey depicts the former extent of the demesne) (source; DEHLG National Inventory of Architectural Heritage) The Ursuline Convent on Finisklin Road is located approximately 1080m from the proposed extension (Site 5; see Figure 13.3). The Convent (operated as a secondary school and referred to as Ursuline College) occupies a detached thirteen-bay three-storey stone convent school, built c. 1860. The building is characterised by the main block with central pedimented breakfront, four bays either side, forward-thrusting gable end, enclosed courtyard to the rear and a Chapel built c.1870. Based on the assessment of importance made by the NIAH, this site has been assessed to be of Regional Importance7. This site is also a protected structure (no.15) under the Sligo and Environs Development Plan 2010-2016.

7 http://www.buildingsofireland.ie/niah/search.jsp?type=record&county=SL&regno=32322003

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Figure 13.3 Location of Ursuline Convent in relation to the proposed extension (source; DEHLG National Inventory of Architectural Heritage – Map Viewer)

13.5.2 Impacts

“Do Nothing” scenario If the proposed extension was not constructed, the identified architectural heritage site would remain in its current condition and use. For this scenario, the significance of impact was predicted to be No Impact for the site.

Construction Phase Impacts The proposed extension is located outside the extent of the former Farmhill House Demesne (Site 4) as shown on the first edition of the Ordnance Survey 6” map. There will be no impact on this site. There will also not be an impact on the Ursuline Convent, there will be no impact on the curtilage of this site. No impacts during construction are therefore predicted. Operational Phase Impacts No trace of Farmhill House Demesne now remains. Operation of the proposed extension will not result in the change of character of the area. The proposed extension is located within an industrial estate and will be surrounded by existing buildings of industrial character. The proposed extension building will form another similar element within this setting.

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Based on this, and the fact that the development is located over 1km from the Ursuline Convent, no impacts during operation are predicted.

13.5.3 Mitigation

Construction Phase Mitigation As no impacts are predicted, no mitigation measures are recommended.

Operational Phase Mitigation As no impacts are predicted, no mitigation measures are recommended.


No residual impacts on architectural heritage sites will result from the proposed extension.

13.5.5 Conclusions

The former site of a demesne associated with Farmhill House (now destroyed) is located within the study area but outside the area of the proposed extension. No impacts during construction or operation are predicted. No mitigation measures are recommended.

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14.0 TRANSPORTATION

14.1 Introduction This section presents the transportation assessment carried out for the proposed extension to the Elanco production facility in Sligo. It is estimated that the proposed extension, once operational, will provide direct employment for a maximum of 10 - 15 No. additional staff. Apart from staff, who will not be generating much additional traffic flow on the local road network, the proposed extension is expected to generate additional heavy goods vehicle movements as the facility distributes ready product to retail facilities across Ireland and abroad.

14.2 Methodology The structure of this section includes a discussion of legislative background, a review of the existing environment, potential impacts in both the construction and operational phases, proposed mitigation measures and residual impacts. An initial site visit was conducted in June 2010 to establish the scale of the proposed extension works and to establish the existing site conditions.

14.3 Relevant Legislation and Policy Context

This section has been prepared taking into account a number of legislative and policy documents. These include:

• Sligo and Environs Development Plan 2010-2016 • Sligo County Development Plan 2005-2011 • Transport 21

Both Development Plans set out specific objectives to meet the changing needs of the areas within its control. All relevant roads objectives and general infrastructure improvements laid out in these documents have been considered and integrated into the assessment where appropriate. ‘Transport 21’ is a capital investment framework under the National Development Plan through which the transport system in Ireland is to be developed. The projects and programmes that make up Transport 21 aim to increase accessibility, sustainability, capacity and quality of public transport throughout the country.

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14.4.1 Site Location The proposed development site is located adjacent to the existing Elanco Production Facility Main Plant. It is located in Finisklin Industrial Estate approximately 1km north west of Sligo City centre, immediately to the west of the N4 Sligo Inner Relief Road. Figure 1.2, Volume 3 shows the location of the site at local level. The existing site is an operational industrial site within the Finisklin Industrial Estate/IDA Business Park. Access to the existing Main Plant is gained via an access road located off the Finisklin Road. The Finisklin Road forms the north west boundary of the site and links directly to the N4 Inner Relief Road in the east and with Finisklin Sea Road (roundabout). Finisklin Road is the main road within the Industrial estate and provides access to a number of businesses located in the vicinity of the Elanco site, including Abbott Ireland and Stiefel Laboratories Ireland. The proposed extension will be operated by Elanco staff. A maximum of 10 - 15 No. additional staff members are predicted as a result of the proposed extension. The facility distributes ready product to retail facilities across Ireland and abroad. Additional heavy good vehicle HGV movements are therefore expected on and off the proposed development site and the adjoining road network. The proposed extension is expected to operate according to existing shift patterns.

14.4.2 Site Description The site is described in detail in Section 5.

14.4.3 Existing Road Network Figure 1.1, Volume 3, shows the existing road network within the vicinity of the proposed development site. The road network includes national, regional and local roads which are discussed in terms of hierarchy below:

14.4.4 National Road Network The national road network in the vicinity primarily comprises the N4 road to Dublin, the N15 to Lifford, County Donegal; and the N16 to Blacklion, County Cavan. The N4 Inner Relief Road opened in September 2005. The road extends for 4.65 km from Carrowroe to Hughes Bridge. It consists of a two-lane, 3.6km dual carriageway through a rural environment from the Sligo-Collooney dual carriageway at Carrowroe to the roundabout at Summerhill College, with grade-separated interchanges at Carrowroe and Caltragh. The final kilometer runs through an urban environment, ending at Hughes Bridge. This new road has improved access to

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Sligo City centre and has greatly reduced traffic volumes in the city. It allowed O’Connell Street to be closed to traffic in August 2006 and will facilitate further enhancements to the city centre in terms of traffic calming and pavement widening. The N4 Inner Relief Road links with the N15 in the north. The N17, N4 (Collooney to Sligo) and the N15 form part of the Atlantic Corridor which loops from Waterford, via Cork, Limerick, Galway, and Sligo to Letterkenny. The upgrading of this route is identified as a specific project to be delivered under Transport 21. There are currently design works ongoing for implementation of the N4/N15 - Sligo to the County Boundary project. A preferred route was adopted by Sligo County Council and Sligo Borough Council in 2006. The route extends from Hughes Bridge in Sligo City to the boundary with Co. Leitrim, a length of 26km. To the east the N4 links with the N16, which is the major link from Sligo to Enniskillen and Belfast.

14.4.5 Regional Road Network A regional road network in the immediate vicinity of the proposed development site comprises:

• The R292 (Strandhill Road) connects Sligo City with Ballysadare (Co.Sligo) via Strandhill, runs parallel to Finisklin Road and is accessed from the estate via Finisklin Sea Road;

• The R291 runs north-west from the N15 (Bundoran Road) to Rosses Point on the northern side of Sligo Bay; and

• The R256 (Hazelwood Road) runs from the N16 in the east, running north from Lough Gill to County Leitrim where it links with N16 again in the village of Shanvaus.

14.4.6 Current and Future Road Network Improvements As outlined in The Sligo and Environs Development Plan 2010- 2016 a Traffic and Transportation Study for Sligo was published in 1999. It recommended the development of a strategic road network, which consisted of the development of the Sligo Inner Relief Road followed by the pedestrianisation of city-centre streets and, at a later stage, by the construction of an Eastern Garavogue Bridge and a Western Distributor Road. Strategic Road Objectives as set out in The Sligo and Environs Development Plan 2010- 2016 are:

Upgrade and realignment of the N4/N15 It is proposed to realign and upgrade this road from Hughes Bridge on the N4, continuing north along the N15 to the Sligo/Leitrim county boundary. Hughes Bridge will be widened to accommodate increased vehicular traffic and will include facilities for cyclists and pedestrians. It is proposed to realign and upgrade the portion of the

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N15 within the Sligo and Environs area to an urban dual carriageway. This will include the upgrading and reorganisation of all junctions to accommodate projected traffic volumes, and to provide facilities for cyclists and pedestrians. In order to improve traffic flows, the N16 shall also be upgraded from the N4/N15 junction to the Duck Street roundabout on the N16. Western Distributor Road. The Western Distributor Road (W2) consists of a two-lane carriageway with cycle lanes and footpaths, beginning at the Caltragh Interchange on the Inner Relief Road and linking to the existing network of roads north of the Strandhill Road via Maugheraboy, Oakfield and Ballydoogan. The road is seen primarily as a route to access and facilitate development in western parts of Sligo. In particular, it will provide access to the proposed new IDA Business Park at Oakfield. The functions of the Western Distributor Road include:

• to provide access to the proposed new IDA Business Park at Oakfield; • to improve access to the existing IDA Business Parks at Finisklin; • to improve access to lands zoned for residential use in the southwestern

quarter of Sligo City; • to improve access to Sligo Regional Airport (Strandhill); and • to provide alternative access to western areas of the City and Environs

without forcing traffic to enter the city centre. Realignment of the N16 Enniskillen Road, It is proposed to realign and upgrade the existing N16 Sligo-Enniskillen Road. The proposal consists of realigning the N16 from the Sligo/Leitrim county border to intersect the existing N15 at Teesan and connect with the realigned N4/N15. A strategic route option for a City Bypass It is proposed to make provision for a future City Bypass. It is envisaged that the bypass will link the N4 at Carrowroe with the realigned N15 and N16 north of the city. A route selection study will determine the optimal route, which will take into account environmental issues, the location of residential areas and the obligation to preserve the integrity of designated ecological sites under the Habitats Directive. Inner Relief Road Corridor Sligo’s Inner Relief Road (IRR) is a strategic transport corridor providing access to the city centre and linkages to the surrounding areas, including the port and Docklands. These linkages need to be maintained and improved. The key to maintaining adequate access and linkages is the ability of the junctions along the IRR to cater for existing and predicted increases in traffic flows over the period of the Plan and beyond. In this regard, the junctions at John Street, Lord Edward Street, Lynns Place and Hughes Bridge need to be improved to increase capacity and maintain the ability of the IRR to provide direct access to the city centre and the surrounding areas, thus facilitating the overall development of the city.

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Among the major roads initiatives being progressed are improvements to the Eastern Garavogue River Bridge which will provide vital access to the eastern side of the city and strengthen the east-west transportation corridors. Also of relevance to the transportation from/to the proposed development site is one of intra-urban roads objectives (Objective T2.4), namely to reserve intra-urban road link from the roundabout on First Sea Road, north to junction with Second Sea Road (L-75011-0), via L-75012-0 (north end of First Sea Road); Second Sea Road (L-25011-0), south-west of Gibraltar Point, east to the Borough Boundary at Finisklin. See figure 14.1 below.

Figure 14.1 - upgrading of Gibraltar Road and its links. All proposed road lines shown on the figure are indicative corridors only.

14.4.7 Existing Traffic Operation Shift patterns at the existing Main Plant are as follows:

• Engineering and production : 06:00 - 14:30 and 14:00 - 22.00; • Production and label packaging: 08:00 - 16:30; • Office personnel: 08:00 - 17:00; and • Bioservices: 06:00am - 14:30 and 12.00 - 20:00.

In addition to car trips related to Elanco staff arrival and departure from site, traffic generated by supply deliveries and finished product leaving the site in HGV occurs daily.

14.4.8 Existing Public Transport Bus Services Existing public transport in the vicinity of the proposed development site includes bus services. Limited public transport bus services currently serve the site directly (no busses go directly past any of the Elanco buildings) but in the wider regional

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context there are substantial bus services that could potentially be linked to the site. Bus Éireann operates four bus routes in the city: one serves the city centre and one serves the western area of the city. The other two routes run from the city to Strandhill and Rosses Point respectively. The bus stop closest to the operating facility is located at 2 km south adjacent to the post depot.

Rail Services Currently Iarnród Éireann provides seven services per day between Sligo and Dublin. Improvements to the Sligo-Dublin rail route identified under NDP 2000-2006 have taken place, resulting in a much improved service, from three trains per day to seven trains per day in each direction. The closest train station to the proposed development site is Sligo City train station, located 1.5 km away. The phased re-opening of the Western Rail Corridor from Ennis to Claremorris is targeted in the current NDP 2007-2013, with the preservation of the line from Claremorris to Collooney included in the Western Rail Corridor project in Transport 21.

14.4.9 Proposed Public Transport Public transport accessibility and catchment area is expected to improve significantly with the implementation of the ‘Transport 21’ Strategy. It may be feasible to use the existing inter-city railway to provide a commuter service from Ballymote to Sligo via Collooney and Ballysadare. The proposed railway station with park-and-ride facilities in Ballysadare would facilitate commuters travelling from West Sligo. The existing railway station in Sligo already functions as a transportation node for the North-West in combination with the nearby bus station. To consolidate the envisaged Transportation Hub, it is proposed to redevelop a wider area by providing an urban square to the east of the railway station and the Inner Relief Road, with good pedestrian linkage to the railway station. As stated in Sligo and Environs Development Plan 2010-2016 as Sligo expands, the bus routes in the city will need to be altered and new routes will have to be created to improve the convenience and accessibility of public transport and to reduce trip-times. The proposed road network enables the provision of a series of loops that can minimise walk times to transport stops and serve the main places of activity (workplaces, schools, the hospital, the Institute of Technology, neighbourhood centres etc.) and the city centre. The local authorities will continue to work with Bus Éireann to optimise bus services for the existing and future city quarters.

14.4.10 Existing Pedestrian Environment The Industrial Estate is served with well-maintained footpaths providing a user-friendly environment for pedestrians. No cycle lanes are currently available within the Finisklin Industrial Estate.

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14.5 Proposed Development

14.5.1 Proposed Site Layout and Access

Access Arrangements The proposed access arrangements and internal layout for the proposed extension is shown in Figure 12.1 – 12.7. During operation, the existing access road will serve the proposed extension as the staff/visitor entrance/access point. The proposed new vehicle entrance is principally for service vehicles only. This entrance will also be used for the construction phase. Temporary safety measures will be in place for all construction traffic. The staff car park will be extended by an additional 6 parking spaces.

14.5.2 Parking Provision Sligo and Environs Development Plan 2010-2016 does not provide requirements or policies on the number of car parking spaces outside the city centre. The existing car park in the north-west corner of the proposed development site will be expanded by 6 additional parking spaces.

14.5.3 Proposed Internal Footpaths The pedestrian route network within the operation area of the proposed development site will be made up of a combination of internal and external corridors and pavements. The internal pedestrian network will provide staff and contractors on site access to work areas as required by operations.

14.5.4 HGV traffic The proposed extension is expected to generate two main types of operational traffic. HGV traffic will be generated. At peak operation approximately 20 Heavy Goods Vehicles (HGVs) are expected to visit the proposed development site on a daily basis to carry out different functions including bringing raw materials, picking up ready products and also removing waste. Car trips will also be generated by staff travelling to work by car every day, however with a minimum increase in staff numbers as result of the proposed extension these will not change significantly.

14.6 Impacts This section outlines the potential impact of the proposed extension based on information outlined above.

14.6.1 Do Nothing Scenario

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The Do Nothing assessment scenario assumes that the proposed extension will not be developed. The existing road network will be subject to the impact generated by normal background traffic growth.

14.6.2 Construction Phase Impacts It is proposed to begin construction immediately after planning permission has been obtained; construction will continue for a period of approximately 12-15 months with a peak of 40-50 personnel including management and supervision staff. Construction works envisaged will include site excavation and spoil removal, building site preparation and laying of foundations and hard surfaces, construction of plant and buildings and out fitting. Construction working hours in general will be restricted to 07:00 to 19:00 Monday to Friday and 07:00 to 16:00 on Saturday. Requirements for working outside these hours will require prior notification to Sligo Borough Council and will be kept to a minimum to avoid disturbance to the surrounding environs.

Construction Staff It is estimated that at during the peak construction period a total of 40-50 construction staff will be required on the site. It is assumed site staff will arrive at the site between 06:00 and 09:00 and leave between 16:00 and 19:00. Construction staff will use a temporary parking area in the site opposite the Elanco facility.

Construction HGV Traffic The number of HGV movements is expected to increase during the construction phase of the proposed extension, particularly during the excavation stage. The number of HGV movements will be primarily dependent upon the amount of excavation required and upon the requirement to move material to and from the proposed development site during the construction period. Access Arrangements There will be a dedicated (temporary) access point for the construction phase (located to the north of the proposed development site).

14.6.3 Operational Phase Impacts Apart from staff, who will not be generating additional traffic flow on the local road network, the proposed development site is expected to generate heavy vehicle movements. However due to a non-significant increase in HGVs entering and exiting the proposed development site’s potential exit points from the Industrial estate namely: Finisklin Road/ N4 Interchange to the east and Finisklin Sea Road/ R292 (Stradhill

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Road), these junctions will not be significantly affected. The overall capacity of national or regional roads will not be affected as a result of operations of the proposed extension.

14.7 Mitigation

14.7.1 Construction Phase Mitigation The contractor will be required to complete a construction traffic management plan to the satisfaction of Sligo Borough Council. The construction traffic management plan will take the following mitigating measures on board: Minimise Construction Vehicle Movements Construction vehicle movements will be minimised through:

• Consolidation of delivery loads to/from the site; • Use of precast/prefabricated materials where possible; • The re-use of ‘cut’ material generated by the construction works on site where

possible, through various accommodation works; • The provision of adequate storage space on site; • The development of a strategy to minimise construction material quantities as

much as possible; • The contractor will endeavour to employ as much of the local population

during the construction phase as deemed feasible in order to reduce travel distances of staff contracted to work on site.

Manage Construction Vehicles Construction traffic will be managed and scheduled in such a way that construction vehicles will not queue on public roads and cause congestion. Vehicle set-down and turning areas on site will vary as the project progresses. They will, however, be located in relation to the vehicle access / egress points, and will be sized to ensure that there is sufficient space within the site to contain the vehicles without causing congestion to the public roads. HGV movements to and from the site will be restricted to specific access routes primarily along the N4 and the Regional R292 routes. Local Environmental Protection The following mitigation and monitoring measures will be implemented to protect the local environment:

• Truck washing facilities will be provided at site entrance to ensure that mud and dust transfer onto the public road surface is minimised;

• Regular road sweeping will take place;

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• Trucks carrying demolition and excavated materials will be covered as required to prevent spread of dust;

• Suitable painted or graphically-covered hoarding around site boundary will be provided; and

• Pre-works survey of general condition of existing access roads will be carried out so that the road network can be restored to its former condition after the construction period.

On-Site Facilities On site accommodation will consist of adequate materials drop-off and storage areas, as well as suitable internal turning area for trucks.

14.7.2 Operational Phase Mitigation As outlined in section 13.4.4 Sligo Borough and Sligo County Council together with the National Roads Authority are progressing a number of road development projects. These improvements to the road network will neutralise any additional trips generated as a result of the proposed extension.


14.8.1 Construction Although every effort will be made to ensure that construction traffic avoids the local road network’s peak periods, there will remain an element of construction traffic at these times. It is expected that the above mitigation measures will reduce the construction traffic impact considerably. It is considered that construction traffic will contribute a relatively negligible increase in traffic volumes on the local road network.

14.8.2 Operation

As outlined in section 13.4.4 Sligo Borough and Sligo County Council together with National Roads Authority are progressing with a number of road development projects. These improvements to the road network will offset any additional trips generated as a result of the proposed extension.

14.9 Conclusions This section presents the transportation assessment out for the proposed extension to the Elanco facility’s Main Plant located in Finisklin Industrial Estate in Sligo. Overall it is considered that construction and operational traffic will contribute a relatively negligible increase in traffic volumes on the local road network. The proposed extension is not expected to have any residual impact on the local road networ

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15.0 WASTE MANAGEMENT

15.1 Introduction This section describes solid and liquid waste generation and management for the proposed extension. An outline of waste management practices and policies is provided from site-specific to regional and national. Potential impacts on liquid and solid wastes are assessed and relevant mitigation measures are proposed.

15.2 Methodology This section of the report assesses the waste management effects of the proposed extension. This has included undertaking a desk-top study of existing documentation and the processes to be included in the proposed development. Consideration has been given to the following with regards to waste management:

• Relevant waste legislation; • EPA, National Waste Report 2006; • EPA, Ireland’s Environment 2008; and • Waste Management Plan for the Connacht Region 2006-2011.

15.3 Relevant Legislation and Policy Context Waste Management is a heavily regulated activity and one on which the European Community places great emphasis. Waste regulation in Ireland has historically been dealt with as a health issue, but as awareness of the environmental impact of increased waste arisings and disposal has grown more complex, legislation has emerged. The Irish government has enacted a number of significant pieces of legislation to ensure compliance with European directives. Four pieces of legislation introduced by the European Community have formed the framework for current European policy and legislation, these are:

• The Framework Directive on Waste i.e. Directive 75/442/EEC as amended by Directive 91/156/EEC;

• The Framework Directive on Hazardous Waste i.e. Council Directive 91/689EEC;

• Council Regulation (EEC) No. 259/93 on the supervision and control of shipments of waste within, into and out of the European Community; and

• Council Directive 1999/21/EC on the landfill of waste.

Such legislation has provided for common terminology and definitions of waste in the requirements for the preparation of waste management plans and for the permitting, control and regulation of waste disposal facilities.

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The Waste Management Act of 1996 (as amended) gave effect to many EU Directives on waste management and has allowed for the publication of many Statutory Instruments on waste management. Within the context of the proposed extension any waste management strategy needs to consider the implications of the Waste Management Plan for the Connaucht Region and its potential to impact both on the construction and operational phases of the proposed extension. EPA National Waste Report, 2008 The National Waste Report found that the total quantity of C&D waste collected in Ireland in 2008 is estimated at 13.5 million tonnes, a drop of 24% from 2007 quantities. The report also shows that of the total volume of C&D waste generated in Ireland, 77% (10.5 million tonnes) of this waste comprised the soils and stones fraction. The remaining 23% (3.0 million tonnes) consisted of waste streams such as rubble, plastic, timber etc The report indicates that 79% (8.4 million tonnes) of the soil and stones fraction was recovered. Of the non soil and stones fraction, there was a reported recovery rate of 62% (1.8 million tonnes).

The report identifies that “the total quantity of C&D waste reported as managed in 2008 (10.5 million tonnes) represented a 24% decrease on that from 2007”.

Ireland’s Environment, EPA, 2008 The EPA’s 2008 report indicates the quality of Ireland’s environment is relatively good, however it recognises that waste generation and resource use have increased considerably in recent years. The report emphasises the importance of the environment as a national asset and the benefit of its protection and enhancement both to the economy and to society. As part of the EPA’s 2020 Vision: Protecting and Improving Ireland’s Environment, the EPA has identified six environmental goals, one of these goals is the sustainable use of resources, including the prevention and minimisation of waste, with the balance safely collected, recycled or recovered and final disposal completed in a way that does not harm the environment. In keeping with the EU waste hierarchy the main conclusion of the report is that prevention is preferable to waste management. Connacht Waste Management 2006 – 2011 This Plan has been developed by the local authorities of Galway City and County, Leitrim, Mayo, Roscommon and Sligo and covers the period from 2006 to 2011. The Connacht waste strategy goals are summarised by the European Union waste hierarchy pyramid (see figure 15.1), which identifies that a new approach to managing waste is required in order to progress towards more sustainable waste

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management. The strategy places emphasis on prevention, minimisation, reuse, recycling and recovery of energy in order to end the over-reliance on landfill disposal. The Waste Management Plan has been formulated to address the challenge of waste management in Connaught, and is guided by international, EU and Irish legislation and policy on waste management. The legal basis for this Plan lies in the Waste Management Acts of 1996 to 2001.

15.4 Waste (Liquid)

15.4.1 Introduction The waste water produced from the proposed extension will comprise two streams:

• Sanitary Wastewater; wastewater from toilets, washrooms and showers facilities; and

• Process Wastewater; – wastewater from production areas.

15.4.2 Description of Existing Environment Elanco is currently regulated under Integrated Pollution Prevention and Control legislation (now codified as Directive 2008/1/EC). The site is in possession of an Integrated Pollution Prevention and Control licence (Reference Number P0090-01) which is granted by the Environmental Protection Agency (EPA). Table 15.1 below gives the licensed emission limits, compared to the actual discharged in 2009 (AER, 2009). The % headroom for additional discharge capacity is also presented. Table 15.1 - Emissions to Foul Sewer

Licensed Actual- (2009) % Head Room

Total Volume 2730 m3/week

(390 m3/day),

430 m3/week

(61.3 m3/day)

85%

Production Facility Volume

2625 m3/week

(375 m3/day)

421 m3/week

(60 m3/day)

84%

Quality Control Building Volume

105 m3/week

(15 m3/day

9 m3/week

(1.3 m3/day)

92%

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As reported in Elanco’s EPA Annual Environmental Report (AER) for 2009, the current average discharge to the foul sewer from the production building is approximately 421 m3/week (60 m3/day). On this basis, the Production Facility is currently utilising 16% of the licensed maximum discharge volume, leaving a head room of 84% for future discharges. The proposed extension will discharge to the same location as the existing Production Facility. A mass emission of 350 kg /week (50kg /day) of chemical oxygen demand (COD) with a concentration limit of 600mg/l is licensed to be discharged to the foul sewer from the production building. As reported in Elanco’s EPA AER, a mass total of 1558kg of COD was discharged to the foul sewer in 2009. This is equivalent to an average discharge of approximately 30kg COD per week. The average COD concentration reported during 2009 was 113 mg/l. Sanitary Waste water from the toilets, washrooms and shower facilities is currently collected on site and combined with process waste water, and surface water runoff into the local authority foul sewer. All waste water is conveyed through the Local Authority system to the Sligo WWTP.

15.4.3 Potential Impacts Process Waste Water The proposed extension processes will generate additional quantities of process wastewater that shall be discharged to foul sewer along with the existing production wastewaters. The process wastewaters from the proposed extension will comprise of a composition of Cleaning In Process (CIP) wastewater which is generated from the cleaning processes required for the pipes and fermentation vessels located within the proposed extension. The average additional volume of process waste water from the proposed extension will be 27 m3/week with a maximum volume up to 34 m3/week for Phase 1 of the proposed extension with an increase of up to 68 m3/week for Phase 2. In addition there will be an increase in COD load of up to approximately 15kg/week.

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The composition of the waste water from the proposed extension is outlined in Table 15.2 below:

Table 15.2 – Proposed Extension Average Waste Water Composition (based on 68 m3/week)

Table 15.3 – Proposed Extension Waste Water Discharge Parameters

Parameter Flow 27-68 m3/wk COD Load ~15.3 kg/wk

Based on a discharge rate of 68 m3/week, the maximum quantity of waste water discharged from the existing Elanco facilities and the proposed extension combined will increase to approximately 498 m3/week.

Waste Water Component

Litres Constituent

(lts)

COD g/l

kg COD/week

Waste Media Soultes and Inactive Bio Mass 550 24 13.2

Drakeol 5 (Homogenised Oil Product) 0.372 0 0

Amphigen (Homogenised Oil Product) 0.124 60 0.08

Polysorbate 80 (Homogenised Oil

Product) 0.280 60 0.016

Monooelate (Homogenised Oil

Product) 0.12 60 0.008

Thimerosal 0 100 0

EDTA 0 300 0

Miscellaneous – Sinks, washrooms etc 2000 1 2

Total kg COD/Week - - 15.3

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Based on a discharge rate of 68 m3/week, the average COD loading discharged from the proposed extension will be approximately 15kg/week which will result in an overall COD loading from the facility of approximately 45 kg/week. The increase in flow from the Elanco facilities, once the proposed extension is operational, will be approximately 6-8% (Phase 1) and increasing up to 16% (Phase 2). The increase in COD loading will be approximately 20-25% (Phase 1) and increasing by up to 50% (Phase 2). At the above revised outputs, this is equivalent to the Elanco site, during the Phase 1 stage, using 0.004% of the dry weather flow hydraulic capacity (12,500,000lts/day) for the Sligo WWTP plant and 0.001% of the WWTP’s COD capacity. Impact of discharges of mercury (Hg) from proposed extension on the WWTP and receiving waters Thimerosal will be used in the new production process as a vaccine preservative. The product is an organomercurial salt chemical. The CIP process will result in concentrations of mercury being discharged in the process wastewaters. To reduce the levels of contaminants from CIP wastewater discharged to the foul sewer, it is proposed to collect the first rinse from the cleaning process instead of discharging to sewer. This material would then be disposed of off site via a licensed waste contractor. The composition of this first rinse wastewater is estimated to contain the largest concentration, up to 90%, of the waste materials. The remaining waste concentrations (10%) will be discharged to the foul sewer in the remaining CIP wastewater. Table 15.4 below summarises the remaining effluent concentration of Hg which will be discharged from the proposed extension to the Sligo WWTP. A conservative approach has been taken here in that the volumes presented assume that there will be no treatment of Hg at the Sligo WWTP and the remaining concentrations will pass through the Sligo WWTP directly to receiving surface water’s.

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Table 15.4 – Effluent Concentrations of Mercury (Hg) from the Proposed Extension

Item Amount Units Notes Flow from proposed extension to WWTP 68,000 lts/wk - Average content of

mercury discharged per week 1000 mg/wk -

Average concentration of Hg to WWTP 0.0147 mg/lt

This figure assumes a steady volume of Hg being discharged

across the week from the proposed extension

Potential concentration of Hg discharged to WWTP from Elanco over one day 0.1029 mg/lt

This figure assumes a worst case scenario, where all the Hg from the

Elanco proposed extension is discharged in one day to the foul sewer and DWF to the WWTP.

Concentration of Hg discharged from WWTP to surface waters over

one day 0.00008 mg/lt

Hg Discharge From WWTP 0.08 ug/lt

This figure assumes a worst case scenario of all the Hg from Elanco being discharged from the WWTP

(assuming no treatment and a WWTP DWF flow of

12,500,000lts/day) directly to the receiving surface waters

The Sligo WWTP’s discharge licence requires that the EC Shellfish Waters Directive is considered for all Hg discharges. The Directive is implemented in Ireland by the European Communities (Quality of Shellfish Waters) Regulations 2006 (SI No 268 of 2006). The limit for Hg contained in the Shellfish Directive is 0.4ug/l. The discharge attributable to Elanco from the proposed extension is 0.08ug/l and therefore even in the absence of dilution in the receiving waters this environmental standard is achieved at ‘end of pipe’ due to Elanco materials being treated at the WWTP. Sanitary Waste Water Sanitary wastewater will be collected in a separate collection system on site and will then be combined with the process water off site and conveyed directly to the Sligo WWTP. Sanitary wastewater will comprise sewage and wastewater from:

• Toilets;

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• Washrooms; and • Shower Facilities.

It is estimated that sanitary wastewater discharge from the proposed extension will result in 1000l per week. In agreement with the EPA, the current IPPC licence will be amended to include the proposed extensions discharge of sanitary wastewater.

15.4.4 Compliance with Legislation Elanco fully recognises its obligations to ensure that discharges to the Sligo County Council sewer will take full account of the requirements of Section 70 of the Water Services Act 2007. Elanco will ensure that Sligo County Council are kept fully aware of any and all changes in the quantity, nature and characteristics of discharges to the sewer which may be caused by changes in production, improvements or upgrading of the facility.

15.5 Confirmation of discharge compliance from Sligo WWTP A meeting was held with Sligo WWTP on the 10th September 2010 to discuss the discharges from the proposed extension.

15.5.1 Mitigation Measures – Wastewater IPPC Licence The sanitary and process wastewater arising from the proposed extension will be managed under the EPA IPPC licence (P0090-01) for the existing facility which will be amended in agreement with the EPA to include waste arsing from the proposed extension. The IPPC licence shall be used to assess the environmental performance of the facility. Manufacturing Process and Containment Measures The vaccine manufacturing process involves the culture of Mycoplasma hyopneumoniae in a closed 1,000 litre stainless steel fermentor and then inactivating the whole cells so that they are innocuous, but still retain the physical surface properties that will enable them to create an immune response when injected into a pig. The inactivated whole cells comprise the sterile antigen. The culture must be separated from the environment during growth or it will become contaminated and unusable. The measures used to achieve this separation also ensure that the microorganism does not escape from the closed process equipment. The antigen is stored within the production suite until a test result indicates that the inactivation process has been successful.

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In summary, the process will produce a sterile bulk antigen, containing whole cells, which cannot be sterilised by filtration. It is therefore essential that the process is operated in an aseptic and axenic manner to prevent adventitious contamination from environmental organisms or process additions. This requirement also means that the environment within the facility will be free of the organism and its release from the facility very unlikely. However, the rooms in the suite where the cultures are grown are at a negative pressure to surrounding airlocks and the air leaving these areas is filtered through high efficiency particulate air (HEPA) filters. These will contain the organism within the building in the unlikely event of a spillage from the closed system that remains on the floor before it is disinfected. Waste that is potentially infected is autoclaved out of the antigen production suite and solid waste is bagged for disposal to landfill. Fire water will be collected from the suite and decontaminated chemically before being neutralised. The equipment and suite have been designed and will be commissioned and qualified to meet or exceed the requirements of Containment Level 2 (CL2) as defined in Draft Safety, Health and Welfare at Work (Biological Agents) Regulations 2010 and the current EC Directive and SI No. 248/1998. Any other microorganism species that requires this degree of separation and containment can also be used in the suite in the future. Site Drainage The proposed extension will be incorporated into the existing site drainage system , with new surface water, foul and process water lines constructed in the northern section of the site. See Figure 8.2 for the site drainage plan. The effluent will be combined and discharged with the existing facility effluent, into the local authority sewer. Environmental Emergency Management Plan Elanco have already established a series of Standard Operating Procedures and Protocols for addressing with Environmental Emergencies. These Procedures and Protocols are predicated on protecting the receiving environment under all circumstances. The Elanco approach is clearly demonstrated by the extent of control and monitoring incorporated into the operation of the existing facility and this will be fully supported for the proposed extension by:

• The development of a comprehensive training programme to ensure that operations staff are properly trained in the operation of the individual unit processes and in the identification of adverse trends which might indicate future problems;

• The incorporation of a detailed programme of preventative maintenance to ensure that all plant and equipment is maintained at optimal performance;

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• The maintenance of an on-site inventory of spares and long delivery replacement equipment;

• Development of effective communication between production team leaders and Sligo WWTP operators;

• Simulation of breakdown and process failure situations to ensure that control systems are working properly; and

• On-going consultation with specialist process providers and industry specialists.

Notwithstanding the best endeavours of management and staff, incidents may occur which can impact the efficiency of the Sligo WWTP and towards this end Elanco will put in place a policy of:

• Recording all incidents; • Communicating all exceedances to Sligo Borough Council; • Investigating all incidents (irrespective of how insignificant) which might have

impacted the efficiency or integrity of the WWTP; • Conducting “lessons learned” with all relevant staff following each such

incident; and • Review of Procedures and Protocols to incorporate the findings of the

“lessons learned” where appropriate.

15.5.2 Conclusions All process waste water and sanitary waste water will continue to be discharged to foul sewer. Based on the additional volumes, characteristics and composition of the waste water arising from the proposed extension it is not anticipated that there will be any negative impact on the Sligo WWTP or the receiving surface waters.

15.6 Waste (Solid)

15.6.1 Introduction Wastes will be generated from the construction and operation phases of the proposed extension. This section of the EIS examines the anticipated types and quantities of wastes generated from both phases. Existing legislation and the legal requirement for the licensing of waste activities, in conjunction with the public awareness of environmental issues, are the driving forces towards sustainable development, energy conservation and waste minimisation. Elanco has a well-developed waste management, minimisation and auditing strategy. This system is aimed at not only managing waste, but also at determining

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the most environmentally beneficial methods for controlling the generation of all wastes, and for reusing, recovering or disposing of them. The approach adopted in this environmental assessment is based on the following:

• Proximity Principle: the treatment of wastes as close to their source as

possible in order to insure that the assimilative capacity of the area is not exceeded and to minimise the indirect effects of the creation of that waste. Adopting this approach will help mitigate against the offsite impacts associated with transport; and

• The Waste Hierarchy: The cornerstone of all waste law is the aim of meeting, as far as is possible, a hierarchy of waste with policies and laws designed to promote measures as high up the hierarchy as possible. See figure 15.1.

Figure 15.1 European Waste Hierarchy Pyramid

15.6.2 Description of the Existing Environment The proposed extension is within the Finisklin Business Park located to the south west of Sligo City. Waste on site currently consists of non hazardous, and hazardous waste. Non-Hazardous Non hazardous waste arisings from site as recorded in the waste management records for the Elanco site in 2009 include; cardboard packaging, waste office paper, used tyvek gowns, mixed dry recyclables, general waste and waste plastic packaging. Hazardous

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Hazardous Waste arisingson site consist of small quantities of chemicals used in the current manufacturing process and the cleaning of the production facility and its equipment. Also waste consumables arising from the manufacturing areas where animal biological agents are used and treated as potentially infectious, or bio hazardous waste. Waste electrical equipment, batteries and fluorescent tubing were also sent off site in 2009 for recycling. All hazardous waste from the facility is disposed of or recycled via licensed waste contractors.

15.6.3 Impacts Do Nothing Scenario In the absence of the proposed extension the Elanco facility will continue to operate and generate the waste streams as discussed above Construction Waste Management- General The EPA estimated that managed construction and demolition waste (C&D waste) generation in Ireland in 2008 was 13.5 million tonnes, of which approximately 69 – 72% was recycled. The typical composition of material is given in Table 15.5 below. C&D waste consists of all waste arising during the construction and demolition stage of a project and is defined under Chapter 17 of the European Waste Catalogue – Construction and Demolition Waste. Table 15.5 Construction and Demolition Waste Composition in Ireland

Category Composition Soils/Stones 45% Concrete, bricks, tiles, ceramics

31%

Metals 6% Asphalt/Tar 1% Wood 7% Other 10%

Source: Construction and Demolition Waste management: A handbook for contractors and Site Managers (2002). A FÁS and Construction Industry Federation Initiative.

Material Quantities The detailed composition and quantity of construction and demolition waste that will be generated during the construction stage of the proposed extension cannot be finalised until the project reaches detailed design and a Bill of Quantities is produced for construction.

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However, initial approximate estimates of materials anticipated in the construction of this facility are shown in Tables 15.6 and 15.7 below.

Table 15.6: Approximate Quantities of Waste generated during Construction (Phase 1)

Waste Type Volume (used)

Units Volumes / Wastes

Earth Moving Cut and Fill

1,000 m3 500

Topsoil 0 m3 0 Imported Gravel 1,000 m3 0 Drainage Materials 600 m 10

Enclosing Wall 200 tonnes 0.5 (Off cuts

only) Precast Concrete 0 m3 0 Site Concrete 300 m3 3

Reinforcement 30 tonnes 1 (Off cuts

only)

Steel 200 tonnes 0.5 (Off cuts

only)

Table 15.7: Approximate Typical Quantities of Wastes (Building Materials) generated during Construction (Phase 1)

Building Materials

Waste Type Volume (used)

Units Volumes / Wastes

Glass / Glazing 100 m2 5 Roofing Materials 700 m2 50 Mechanical Piping 800 Lin meters 50 Electrical Wiring 5,000 Lin meters 500 Insulation 700 m3 50 Internal Walling 400 Lin meters 20 Sample Metric Doors 50 numbers 0

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Generation, Re-use and Disposal of Excavated Materials The construction of the proposed extension will involve the excavation and disposal of materials and importation of construction materials for the fill below buildings etc. It is estimated that approximately 1,000m3 of material will be excavated during the construction period. The spoil generated can generally be divided into two categories, material described as construction and demolition (C&D) material and clean earth, clay and weathered rock (inert). C & D Material The C&D material will predominantly be generated by the removal of any existing hardstanding and around existing buried services. The C&D material will be made up of concrete and bituminous materials. Spoil Handling On-Site C&D material and “unsuitable” material will normally be removed immediately from site. If the Contractor considers that the C&D material is suitable for re-use on site, it can be stockpiled in a suitable location, subject to appropriate conditions stipulated in the contract documents and to the acceptance of the EPA and Local Authority. Waste Segregation Where possible, it is planned to separate waste streams at source so as to make recycling or reuse easier. Food waste will be kept in a separate skip and will be appropriately demarcated. Paints, sealants and hazardous chemicals etc will be kept in purpose made containers and hazardous materials disposed accordingly off site to appropriately licensed land fill sites. Importing Materials In line with the principles of sustainable development, the proposed extension will seek to minimise the amount of materials brought into the construction site. This will be achieved by re-using as much of the materials generated during construction as possible, provided that they satisfy the specific engineering standards. The majority of new materials brought to site, such as earthwork materials and pipes will be used immediately or will be stored on site within the site boundary. Other materials such as asphalt or concrete will be brought directly to the construction site from the relevant batching plant as and when required and immediately placed. Other Construction Wastes Other wastes produced during the construction process include; soil, ballast, concrete, asphalt, bricks, tiles, plaster, masonry, wood, metal, paper and plastics. The Hazardous waste streams which could arise from construction activities may include the following:

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• Waste electrical and electronic components • Batteries • Asbestos • Wood preservatives • Liquid fuels • Contaminated soil

A Waste Management Plan (WMP) will be developed and will identity the onsite opportunities for the minimisation and reuse of excavated material along with the opportunities for incorporating recycled material into the works. Waste disposal will be in accordance with all relevant regulatory requirements. Waste Water During construction, a small amount of temporary facilities such as portable toilets and holding tanks will be required to be installed and regularly maintained and the contents of these tanks pumped out and disposed of at a licensed facility via a licensed contractor. Operation Waste Management The proposed extension will operate under the existing Integrated Pollution Control Licence (P0090-01) which will be extended to include the operations of the extension. Non-Hazardous Wastes A range of non-hazardous waste streams are expected to be generated during the operation of the proposed extension, this will include cardboard packaging, waste office paper, used tyvek gowns, mixed dry recyclables, general waste and waste plastic packaging. Hazardous Waste Hazardous solid wastes will be wastes such as waste oils, batteries, laboratory chemicals, medical waste etc will be generated as a result of the operation of the proposed extension. It is envisaged that they will be segregated at their source. On segregation, they will be stored in suitably labelled containers prior to their removal and disposal offsite by an appropriately licensed third-party waste company. Hazardous solid waste may also be generated as a result of the site processes. Inactivant material which is not used during the site process and is required to be disposed off site by a suitably licensed waste contractor in accordance with the current site practises which are licensed as part of the existing IPPC licence. Table 15.8 outlined below reflects the solid hazardous waste streams generated at the existing facility in 2009. It is envisaged that similar solid waste streams will results from the proposed extension.

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Table 15.8 Potential hazardous waste production and management during operational phase

Elanco reported that in total 65.2 metric tonnes of hazardous waste were disposed off site in 2009 from the existing facility. The current off site recovery and disposal routes have been approved by the EPA as part of the sites IPPC licence. It is considered that the solid waste rates from the proposed extension will be in the region of approximately 30 metric tonnes per annum in total

EWC Code Waste Type

060105* Nitric Acid labs small 060106* Lab Waste (Acidic) 060204* Lab Waste (Caustic) 060205* Lab Waste (Basic) 060404* Lab Smalls (Mercury) 070504 Organic Solvent Waste (I sopropanol) 080111 Waste Paint Tins 130205 Waste (Rubia) Oil 130307 Waste (Antifreeze) Refrigerant 130310 Waste Refrigerant Oil 130899 Waste Oil and Oily Contaminated Water 140603 Waste Formalderhyde Solution 150110 Empty Paint Tins 150202 Wipes Contaminated with Oil 160213 Waste Electrical – Mixed WEEE 160305 Organic Waste Containing Dangerous

Substances 160504 Waste Aerosols 160506 Mixed Lab Chemicals (including mixtures) 160507 Mixed Lab Chemicals (Inorganic) 160508 Mixed Lab Chemicals (Organic) 160601 Waste Batteries 160903 Waste Hydrogen Peroxide 180103 Reject Product (vaccines) 180202 Waste for processes involving live animal

viruses and bacteria 200121 Waste Electrical - Mixed WEE and

Florescent tubes 200123 Waste Electrical 200135 Waste Electrical – Mixed

WEEE

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In addition and as identified above, to reduce the levels of CIP wastewater being discharged to the foul sewer, it is proposed to collect the first rinse from the cleaning process and store this separately on site prior to off site disposal with a licensed waste contractor. It is expected that in the region of an additional 2.6 tonnes approximately per year of this wastewater will require disposal off site from the proposed extension. All volumes, off site recovery, disposals routes and relevant waste records relating to the proposed extension will be undertaken in accordance with legislative requirements and with the requirements of the IPPC licence. Elanco will ensure that the EPA, with regards to the IPPC licence, are kept fully informed of any and all changes in the quantity, nature and characteristics of the waste streams resulting from the proposed extension.

15.6.4 Mitigation Construction Phase Mitigation A site Waste Management Plan (WMP) will be developed during construction which will define a structured approach to the management, and recycling of waste onsite and identify licensed waste management contractors. The WMP objective will be to provide better control of the regulatory risks relating to materials and wastes generated onsite with the result that any queries from the Environmental Protection Agency can be dealt with effectively. This will be prepared as per the Best Practice Guidelines Projects on the Preparation of Waste Management Plans for Construction and Demolition Projects which is available from the Department of Environment, Heritage and Local Government. These guidelines outline, among other recommendations, that waste can be minimised by:

• Ensuring the correct volume of materials is ordered for the work to be undertaken and storing the materials appropriately to avoid contamination or deterioration;

• Co-ordinating with other contractors or developers in the supply of materials and services to avoid repeated deliveries or excavations; and

• Ensuring when preparing contracts for demolition and construction operations that clauses are included requiring the reuse of materials where practicable.

• The waste management plan will typically include: • The organisation of the contractor’s approach to waste management including

permit details etc; • the identification of disposal sites; • the identification of quantities to be excavated and disposed of; • the identification of measures to prevent nuisance; • the identification of the amounts intended to be stored temporarily on site and

the location of such storage; • the identification of intended transport means for materials;

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• procedures for dealing with Waste Management including liaison with third parties, statutory bodies, undertakers and other companies;

• procedures for the control of off-site activities associated with the Waste Management; and

• procedures for the management review/audits to monitor and demonstrate control over the implementation of the WMP.

Operational Phase Mitigation The operational phase of the proposed extension will result in the generation of a range of hazardous and non hazardous wastes including sanitary and process waste water and a limited amount of cardboard, plastic and general waste. The sanitary and process water arising from the proposed extension will be managed under the existing EPA IPPC licence (P0090-01) for the facility which will be amended in agreement with the EPA to include waste arsing from the proposed extension. The IPPC licence shall be used to manage the environmental performance of the facility.

15.6.5 Residual Impacts With the recommended mitigation measures in place the residual impact of the proposed extension are not considered significant.

15.6.6 Conclusions A summary of the key finding is presented below: It is anticipated that approximately 620m3 of waste material will be produced with approximately 570 line meters of piping/wiring and 2 tons of off cuts during the construction phase of the proposed extension A site Waste Management Plan will be developed for the construction phase which will define a structured approach to the management, and recycling of waste onsite and identify licensed waste management contractors. This will give consideration to the proximity principal and the waste hierarchy. The existing IPPC license for the facility will be amended to include for appropriate management and disposal of the process waste water and also the additional solid waste streams which will be generated as a result of the operation of the proposed extension.

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16.0 MATERIAL ASSETS

16.1 Introduction

This section provides an assessment of the potential impacts of the proposed extension on material assets. The purpose of this section is to discuss the utility services that are to be provided for the proposed extension, including:

• Potable Water; • Waste water; and • Electricity Supply.

16.2 Methodology

This section of the EIS was carried out in accordance with the Guidelines on current practice on the Information to be contained in the preparation of an EIS (EPA, 2003).

16.3 Receiving Environment

16.3.1 Potable Water The Elanco site is currently served with potable water by a connection to the existing Sligo Town Water Supply (Sligo County Council water main). On average there is one outage per annum. The water supply is metered and the current annual consumption of water is 23,000m3 (2009) or an average of 63 m3/day. The water is fed into a 400 m3 storage tank and pumped to the main plant boiler house where it supplies the main plant at 6 bar in order to overcome the pressure drops in the pretreatment system. In the event this supply is lost there is also a direct feed from the council mains which is at 2.5bar.

16.3.2 Wastewater The Elanco site currently discharges effluent to the existing Sligo sewerage system via two discharge points; the production building (Main Building) and the quality control department. The facility is currently licensed to discharge up to 375m3/day and 15m3/day respectively under their EPA Integrated Pollution Prevention Control licence (IPPC; P0090-01). See Appendix 8.1 for a copy of Elanco’s IPPC licence. The water discharge is metered and the current annual discharge of wastewater is 21,900m3 (2009). Based on this the current system average demand is circa 60 m3/day.

16.3.3 Electricity Supply

The sites electrical supply is currently served by a connection to the existing ESB 10 kV electricity supply system. The highest measured maximum demand (MD) is

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recorded at 693kVA or 1054 Amps at 380V. The contracted maximum import capacity (MIC) from the ESB is 700kVA, or 1063A at 380V.

16.4 Characteristics of the Proposed Extension

The proposed extension will require additional building space and new process equipment to the existing facility and will have the following demand on utilities.

16.4.1 Potable Water

The proposed extension will increase the overall requirement from the public water supply for use of Deionised (DI) Water, Water for Injection (WFI) and Pure Steam. There will be a slight impact on the Citys water but the increased demand will not exceed 25-50% of the current demand resulting in circa 5750 -11500m3 per annum increased demand in potable water.

16.4.2 Wastewater Production

The current licence limit is 390m3/day to the council sewer. The current system demand is circa 60m3/day; the extra load is not expected to exceed 4% of the current existing discharge resulting in and increased discharge of 4 - 5 m3/day to a 9 - 10 m3/day fro Phase 2. This will not exceed the current IPPC limit.

16.4.3 Electricity

The contracted maximum import capacity (MIC) from the ESB is 700kVA, or 1063A at 380V. Based on the above the current ESB MIC is almost at capacity. An increase in MIC will be required for the proposed extension. The total facility load after the proposed extension will be in the order of 700kVA (existing) + 122 kVA (new) = 822 kVA, minimum MIC increase of 122kVA. There will be a slight impact on the Electricity supply but the increased demand will not exceed 15-25% of the current demand.

16.5 Impact of the Proposed Extension Initial consultation with the relevant utility companies has indicated that the proposed extension will not impact on the existing supply/discharge systems. The anticipated increase in load is acceptable with sufficient capacity available to take the proposed increased volumes of utility use.

16.5.1 Do Nothing Scenario

The do nothing scenario would be no additional consumption/use of the existing infrastructure/utilities.

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16.6 Mitigation & Monitoring

Extensions to utilities will be constructed in accordance with the requirement of the relevant utility companies (the ESB and Sligo County Council etc) to avoid /minimise disruption to their services. Onsite water consumption will continue to be monitored using water meters. Wastewater discharges are limited to the volumes set out in the IPPC licence and will continue to be monitored as required under the IPPC licence. A monitoring programme will be introduced at each operational building unit for energy usage.

16.7 Residual Impact

The proposed extension will have no residual effect on material assets.

16.8 Conclusion

The overall predicted impact will be neutral long term in nature for material assets.

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17.0 INTERACTION OF THE FOREGOING AND CUMULATIVE IMPACTS

17.1 Introduction

This section presents a summary of interactive environmental impacts within the scope of the proposed extension, and a summary of the cumulative impacts with future adjacent proposals.

17.2 Planning Context Schedule 6 of the Planning and Development Regulations 2001, which reflects Article 3 of the EIA Directive, specifies that an EIS should include: A description of the aspects of the environment likely to be significantly affected by the proposed extension, including in particular:

• “Human beings, fauna and flora; • Soil, water, air, climatic factors and the landscape; • Material assets, including the architectural and archaeological heritage, and

the cultural heritage; and • The inter-relationship between the above factors.

A description is also required of the likely significant effects (including direct, indirect, secondary, cumulative, short, medium and long-term, permanent and temporary, positive and negative) of the proposed extension on the environment resulting from:

• the existence of the proposed extension; • the use of natural resources.

The EPA Guidelines define cumulative impacts as; “The addition of many smaller impacts to create one larger more significant impact.” The EPA Guidelines also employ the term Synergistic Impacts, which is defined as: “Where the resultant impact is greater than the sum its constituents.” The EU has also prepared guidelines for this area of EIA: Guidelines for the Assessment of Indirect and Cumulative Impacts as well as Impact Interactions (Office for Official Publications of the European Communities, May 1999). These Guidelines employ the following definitions:

• Cumulative Impacts: Impacts that result from incremental changes caused by

other past, present or reasonably foreseeable actions together with the project.

• Impact Interactions: The reactions between impacts whether between the impacts of just one project or between the impacts of other projects in the areas.

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The potential for significant cumulative impacts and interactions has been addressed in the baseline and impact assessment sections of this EIS; this section provides a summary and overview of these effects.

17.3 Assessment Methodology In the context of the guidance presented above, the assessment of cumulative and interactive impacts resulting from the proposed extension has employed the following definitions: Interactive Impacts - separate environmental impacts resulting from the proposed extension may combine in space or time to create one or more larger, more significant impact. Cumulative Impacts - separate environmental impacts resulting from proposed extension may combine with impacts from surrounding future development schemes (with similar environmental resources), in space or time to create one or more larger, more significant impact(s). Individually the effects of a development may be of minor significance but when combined with the impact of any of the other developments proposed in the wider area the overall significance could be increased above the sum of the individual development effects. As larger and smaller development proposals emerge within the surrounding area, cumulative impacts should be considered to ensure that environmental capacity is not breached and any impacts are adequately foreseen and managed. When assessing interactive and cumulative impacts, the significance of any identified impact is considered by assessing the predicted magnitude of the impact and the sensitivity of the receiving environment. The likelihood of significant interactive, cumulative or combined impacts occurring is also considered. Impacts which are considered to be significant are discussed below. The results of the assessment will enable Sligo Borough Council to ensure that the proposed extension and other foreseeable developments in the surrounding local area are mutually compatible in relation to the environmental capacity of the area / resource on which they impact.

17.4 Interaction of the Impacts

Due to the relatively small nature of the proposed extension and the existing land use being an industrial estate it is not anticipated that there will be significant interactions between impacts either in number or magnitude. The main impact interaction will be in relation to socio economic, air and noise impact as outlined below.

17.4.1 Socio-Economic

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Impacts on the human environment, including the people resident nearby, have been addressed throughout the EIS. While Section 6 (Socio-Economic) deals specifically with the impacts on land-use and planning, population, employment, socio-economics, separate assessments have also been carried out on the other fundamental aspects that can affect people living in the vicinity of the proposed extension, specifically noise and air quality. No significant impacts have been identified in relation to these two aspects and with proposed mitigation measures taken into consideration, the overall (interactional) impact on the human environment is considered to be mildly negative (but temporary) during the construction phase and negligible as the proposed extension moves into the operational stage.

17.5 Cumulative Impacts This section considers the cumulative effects that the proposed extension could cause through interaction with existing activities in the area, as well as the construction and operation of future developments in the vicinity.

17.5.1 Cumulative Effects – Existing Activities Potential effects arising from the construction and operation of the proposed extension have been considered cumulatively, with the effects of existing activities (primarily industrial manufacturing) in the region, throughout the relevant chapters of this EIS. Under each EIS impact heading, the existing baseline environmental conditions were clearly and accurately established prior to identifying and assessing the impacts associated with the proposed extension. In summary, the main baseline studies undertaken for this EIA were as follows:

Socio-Economic – Desk-top and local area surveys were carried out on land-use, population, health and employment in the region. Flora and Fauna – Assessment was based upon the findings of the assessment of ecological impacts which was undertaken by Scott Cawley Environmental Consultants. Field surveys were carried out to establish baseline conditions and a desk-top study examining existing ecological information for the locality was also completed, in conjunction with a literature overview. Surface Water – The baseline status of water quality in the area has been established on the basis of monitoring and reporting conducted by the EPA on the River Garavouge. (Note there are no direct discharges to surface water from the proposed extension). Soils, Geology and Hydrogeology – An extensive desk based investigation have informed this section of the EIS.

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Noise and Vibration – Baseline environmental noise was measured during day-time and night-time surveys at locations around the proposed development site and proximate to the nearest residence to the proposed development site. Air Quality and Climate – A desk-top study of air quality data for the locality was carried out in conjunction with a baseline air quality monitoring programme for nitrogen oxides. Landscape and Visual Impact – Desk-top and local area studies of the site and its environs were conducted to assess the existing quality and type of views in the area and the extent of the visual envelope. Site Archaeology, Architecture and Cultural Heritage – Extensive desk based investigations were carried out to establish baseline conditions of the site. In accordance with the above, the assessments of impacts associated with the proposed extension takes full account of the prevailing environmental effects associated with other existing activities in the area. Similarly, the proposed measures for the mitigation of impacts and the quantification of residual impacts take due regard of other impacts arising from local sources.

17.5.2 Cumulative Effect – Future Projects Other known future projects outside the scope of the proposed extension which may be undertaken in the vicinity of the proposed development site are:

1. The proposed redevelopment of the grounds of Ursuline College to mixed

residential and commercial landuse. This proposed development is approx 340 m south east of the proposed extension; and

2. The proposed development of 130m of roadway to facilitate access within the Finisklin Industrial Estate, located approx 155m south east of the proposed extension.

Where appropriate, this EIS has considered in general terms the potential impacts of future projects. These projects in turn require their own planning permission and appropriate environmental assessments. This EIS has considered cumulative impacts where it is felt that they are relevant to the proposed extension.

There are no other known developments currently at planning or early construction stage in proximity to the proposed development site. Based on the relative sizes and types of activities that would be undertaken at the known proposed developments, it is concluded that these will not give rise to significant cumulative effects during construction or operation.

In addition, objectives within the Sligo and Environs Development Plan 2010-2016 include:

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• The promotion of development of office-based business, technology

companies and industrial units within the Finisklin industrial estate; and • The redevelopment of the ground of Ursuline College as mixed residential

and commercial land.

Therfore both the proposed extension and redevelopment are in line with the objectives set out in the SEDP 2010-2016. This plan has been subject to Strategic Environmental Assessment (SEA) under the European SEA Directive 2001/42/EC, the process by which environmental considerations are required to be fully integrated into the preparation and adoption of plans and programmes.

17.6 Conclusions

Based on the above assessment the conclusions in relation to cumulative effects are:

• The receiving environment is robust. • Services have sufficient capacity. • The cumulative effects of all developments, when combined, will not

adversely affect the receiving environment.

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18.0 SUMMARY OF MITIGATION MEASURES The following environmental commitments are an integral element of the application for Approval. Development in new technology may offer opportunities to further reduce the significance of impact and, in some cases, improve the residual impact. In this way the mitigation strategies, objectives and implementation measures set out below may be refined so to provide the optimum solution based on available construction techniques and technologies at the time of construction. Best practice and good construction practice when referred to in this document refer to measures contained in modern guidance documents which set out the practice and procedures for environmental protection during construction and operational phases of a development. Where Legislation, Standards or Guidance Documents are referred to it should be noted that at the time of construction or operation of the proposed extension any amendments to these documents are applicable. The purpose of this document is to provide a summary of the main commitments under each of the environmental headings listed. Full details of the various commitments should be obtained by reference to the individual sections and to the Environmental Impact Statement as a whole. In the following tables "C" denotes a commitment which refers mainly to the construction phase and "O" denotes a commitment which refers mainly to the operational phase of the proposed extension.

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18.1 Socio-Economic

No. Stage Socio-Economic Commitments EIS Reference

1 C/O

No specific mitigation measures are proposed in this Section to ameliorate the impacts on human beings as the potential impacts are negligible.

6.7

18.2 Ecology

No. Stage Ecology Commitments EIS

Reference

1 C

Protection of Habitats All construction works will be largely limited to the footprint of the construction works or in existing hardstanding areas. Limited works, however, (including excavation, material storage or site compounds) will take place within or adjacent to the Treelines, Dry Meadow or Recolonising Bare Ground habitats. If required, exclusion zones will be created around these areas (allowing for root protection zones) in order to demarcate areas of sensitive habitats. Some existing newly planted tress may have to be removed during construction.

7.7

2 C

Additional tree and hedgerow planting will be added along the northern boundary of the site, and this should include only native and naturalised tree species. This would provide greater ecological value than non-native species.

7.7

3 C

The appointed contractor will have regard to the following guidelines to ensure that groundwater is adequately protected from construction work:

� Requirements for the protection of fisheries and

habitats during construction and development works at river sites. Eastern Regional Fisheries Board (2006).

7.7

4 C

The contractor will prepare a method statement, which will have regard to the above and advice from Inland Fisheries Ireland, and will include specific measures in relation to the following: � Methods to control run-off of silt and suspended solids; � Response measures to potential pollution incidents;

7.7

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No. Stage Ecology Commitments EIS

Reference � Appropriate storage (e.g. on impermeable surfaces) of

fuels, oils, greases and hydraulic fluids; � Control of run-off from concrete mixing; � Appropriate locations and size of stockpile areas for

sands and gravel; and � Inspection and maintenance of settlement ponds if

they are proposed as a construction control measure.

5 C

Nesting birds It is an offence under the Wildlife Act 1976 (as amended) to intentionally kill birds or destroy nests. It is recommended that in accordance with best ecological practice, hedgerows, trees, scrub and woodland areas will not be felled between 1st March and 31st August.

7.7

18.3 Surface Water and Drainage

No. Stage Surface Water Commitments EIS Reference

1 C

Mitigation measures applicable to both soils, surface and ground waters are provided in Section 9 Soils, Geology and Hydrogeology and should be referenced for construction mitigation measures relating to surface waters. All surface water runoff on site during construction will be contained and discharged to foul sewer.

8.5.1

2 O

A range of mitigation measures have been developed to address surface water quality, drainage and attenuation issues in light of current requirements. Measures include: � All surface water run off from the existing facility and

the proposed extension will be discharged to local authority foul sewer, and in accordance with the IPPC licensing and monitoring requirements for the facility;

� The manually operated shut off valve is located on the foul, surface water, process waste water line prior to discharge off site to prevent contaminated water used in the event of a fire, being automatically released to the local authority sewer without prior consent/notice;

� The bunded fuel delivery area will be made impermeable to prevent fuel release off site discharging to local authority sewer; and

8.5.2

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� All containers holding bulk chemicals, wastes and fuels will be stored on spill trays with a capacity to contain 125% of the volume of material stored.

3 O The emissions to sewer will be monitored in accordance with the conditions of IPPC licence P0090-01 which will be amended to incorporate the proposed extension.

8.5.3

18.4 Soils and Geology

No. Stage Soils and Geology Commitments EIS

Reference

1 C

Earthworks operations shall be carried out such that surfaces as they are being raised shall be designed with adequate falls, profiling and drainage to promote safe run-off and prevent ponding and flooding. Run-off will be controlled through silt/sediment traps as appropriate to minimise the turbidity of water in outfall areas. Care will be taken to allow that the bank surfaces are stable to minimise erosion.

9.1.6

2 C

Subject to appropriate control and testing, spoil derived from excavation for the proposed extension could be re-used as engineering fill where required for roadways and other structures. The geotechnical properties of this fill would require assessment to determine it’s suitability for such use. This will minimise the requirement to import fill material to site.

9.1.6

3 C

Pollution will be minimised by the implementation of good construction practices. Such practices will include adequate bunding for oil containers, wheel washers and dust suppression on site roads, and regular plant maintenance. The Construction Industry Research and Information Association (CIRIA) provides guidance on the control and management of water pollution from construction sites in their publication “Control of Water Pollution from Construction Sites, Guidance for Consultants and Contractors (Masters-Williams et al, 2001)”. This document will be utilised on site.

9.1.6

4 C

Good housekeeping (daily site clean-ups, use of disposal bins, etc.) on the project site, and the proper use, storage and disposal of many substances used on construction sites, such as lubricants, fuels and oils and their

9.1.6

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containers will be implemented to mitigate against soil contamination.

5 C

Best practice construction techniques will be implemented in re-working any excavated material to minimize dust generation, groundwater infiltration and generation of runoff. Construction and demolition waste encountered in reworking this material will be disposed of, if appropriate, off site in accordance with the requirements of the Waste Management Acts, 1996 and 2001.

9.1.6

6 C

Oil storage tanks will be bunded appropriately. Smaller quantities of hydrocarbon substances will be stored in suitable, secure buildings or enclosures with an impermeable floor surface.

9.1.6

7 C

Appropriate measures will be put in place to minimise the risk of soil contamination from re-fuelling of vehicles, e.g., re-fuelling to be undertaken in designated areas with drained hard standing, and spill kits in place.

9.1.6

8 C

A contingency plan for pollution emergencies will also be developed by the appointed Contractor prior to work and regularly updated, which would identify the actions to be taken in the event of a pollution incident.

9.1.6

9 C

Site specific target levels (SSTLs) will be identified for the soils to be retained within the site that are protective of all human/environmental receptors. Only soils with concentrations below these target levels will be retained on site within the landscaped areas.

9.1.6

10 O

Sewer and drainage connections will not be damaged if designed constructed using appropriate skill and care. The relevant design codes and construction supervision will be employed to ensure the connections are sufficiently robust and completed to the appropriate standards.

9.1.6

11 O

In most cases, good housekeeping (daily site clean-ups, use of disposal bins, etc.) on the project site, and the proper use, storage and disposal of lubricants, fuels and oils, detergents and other chemicals harmful to the environment and their containers can mitigate against soil contamination.

9.1.6

12 O Oil storage tanks, if located within the area of the 9.1.6

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proposed extension, will be sited on bunded hard standing. Smaller quantities of potentially harmful substances will be stored in suitable, secure areas with an impermeable floor surface. Oil interceptors will be installed to intercept spillages of fuel which may occur outside of the bunded area.

18.5 Hydrogeology

No. Stage Hydrogeology Commitments EIS

Reference

1 C

The following mitigation measures will be implemented as a minimum during the construction stage to mitigate against impacts on the hydrogeology of the site and the Sligo Ground Water Body as a whole:

9.2.7

2 C

� To minimise any impact on the underlying subsurface strata from material spillages, all oils, fuels, solvents and paints used during construction will be stored within specially constructed dedicated temporary bunded areas;

9.2.7

3 C

� Oil and fuel storage tank will be stored in these designated areas, when not in use and these areas shall be bunded to a volume of 110% of the capacity of the largest tank/container within the bunded area;

9.2.7

4 C

� Filling and draw-off points will be located entirely within the bunded area. Drainage from the bunded area shall be diverted for collection and safe disposal as required under the IPPC licence;

9.2.7

5 C

� Where possible refuelling of construction vehicles and the addition of hydraulic oils or lubricants to vehicles, will take place in a designated area of the site which will be away from surface water gulleys or drains;

9.2.7

6 C � An adequate supply of spill kits and hydrocarbon

adsorbent packs will be stored in the area;

9.2.7

7 C � An adequate supply of spill kits and hydrocarbon

adsorbent packs will be stored in the area;

9.2.7

8 C � All relevant personnel will be fully trained in the use of

this equipment. These measures will ensure that 9.2.7

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accidental inputs to and subsequent contamination of ground water and surface water do not occur during normal and or emergency conditions; and

9 C

� All waste management during the construction phase of the propsoed extension will be carried out in compliance with the requirements of the facilities IPPC Licence.

9.2.7

10 O

The operational standard operating procedures (Refer to the Waste Management Section 15 for further details) will incorporate the correct handling and storage of potentially contaminating materials at the facility, and will go towards achieving full containment. The following measures will be implemented during operation:

9.2.7

11 O

� All process/surface water from the operation of the proposed extension will be discharged to foul sewer in accordance with the conditions of the IPPC licence for the Elanco facility;

9.2.7

12 O

� There is no direct release of surface water from the facility to surface water bodies during construction or operation;

9.2.7

13 O

� Ultimate release of the water discharges from the Sligo Waste Water Treatment Plant to Slifo Bay will be under the conditions of EPA Waste Water Discharge License held by the WWTP;

9.2.7

14 O

� Pollution prevention requirements of the contractor have been proposed and these will reduce the risk of groundwater contamination as a result of construction works.

9.2.7

18.6 Noise and Vibration

No. Stage Noise and Vibration Commitments EIS Reference

1 C

All construction work would be undertaken to the guidance in British Standard 5228: 2009 – Code of practice for noise and vibration control on construction and open sites – Part 1: Noise and Part 2: Vibration.

10.7.1

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2 C

It is considered unlikely that the noise and vibration evels generated during construction will result in significant impacts or exceed any limits imposed by the Local Authority at nearby noise sensitive receptors. As such, it is considered that no specific mitigation measures are likely to be required during the construction phase.

10.7.1

3 O

The noise assessment has demonstrated that the noise impact of the proposed extension is unlikely to result in a breach of the IPPC licence limits for both the daytime and night-time periods. No specific noise mitigation measures have been specified within the noise modelling exercise, indeed no attenuation at the AHU inlet and exhaust louvers has been applied. The proposed extension has been assumed to be constructed entirely from ‘Kingspan Louvre Panel Complete Wall & Façade System’ which has a Sound Reduction Index (SRI) spectrum as shown in Table 10.10. With the exception of the level of sound reduction required for the main building no specific noise control measures have been specified. No noise attenuation at the louvers has been included within the noise model.

10.2.7

18.7 Air Quality

No. Stage Air Quality Commitments EIS Reference

1 C

The only likely air quality impact during construction will be the generation of fugitive dust. In order to mitigate any potential emissions arising from fugitive dust during the construction phase, (and hence minimise potential impacts), a ‘Contractors’ Code of Conduct for the Control of Fugitive Dust’ will be developed in consultation with the Local Planning Authority, to avoid, reduce and remedy significant adverse impacts on air quality. Typical elements of such a code are set out in Appendix 11.1 and could be used during construction of the proposed extension.

11.5.1

2 C

Mitigation measures to reduce climate change emissions other than normal engine maintenance by the contractor and their plant will not be required during the construction phase.

11.5.1

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3 O

There will be no additional generator type equipment being for the proposed extension installed, as it is anticipated that capacity of the equipment from the existing facility will be used.

11.5.2

4 O

In general terms, both climate change and health impact air pollutant emissions from the proposed extension will be reduced approximately in relation to the reduction of the use of fossil fuels to provide energy. The greatest contribution to mitigating the energy consumption of the proposed extension will rely on the extension design and construction. The technologies selected to provide its energy requirements will determine the actual emissions of health impact air pollutants.

11.5.2

18.8 Landscape and Visual

No. Stage Landscape and Visual Commitments EIS Reference

1 C/O

Mitigation for landscape and visual impact has been considered within the design and development of the proposed extension.

12.7

2 C/O

There are no specific mitigation measures proposed to ameliorate the impacts on the landscape and visual environment.

12.7

3 C/O

It is considered that the proposed extension has been organised in terms of design and layout to take cognisance of the design of the existing facility and of its setting within the industrial estate. The proposed extension is not considered significant in scale and there will be limited visibility into the site. In addition, as identified in the 3D visualisations in Appendix 12.1, height of the proposed extension and proposed cladding for the external façade will be similar to the green colour of the existing facility.

12.7

18.9 Cultural Heritage

No. Stage Cultural Heritage Commitments EIS Reference

1 C/O As no impacts are predicted, no archaeological mitigation is recommended.

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18.10 Transport

No. Stage Transport Commitments EIS Reference

1 C

The contractor will be required to complete a construction traffic management plan to the satisfaction of Sligo Borough Council. The construction traffic management plan will take the following mitigating measures on board: Minimise Construction Vehicle Movements Construction vehicle movements will be minimised through:

� Consolidation of delivery loads to/from the site; � Use of precast/prefabricated materials where possible; � The re-use of ‘cut’ material generated by the

construction works on site where possible, through various accommodation works;

� The provision of adequate storage space on site; � The development of a strategy to minimise

construction material quantities as much as possible; � The contractor will endeavour to employ as much of

the local population during the construction phase as deemed feasible in order to reduce travel distances of staff contracted to work on site.

14.7.1

2 C

Manage Construction Vehicles Construction traffic will be managed and scheduled in such a way that construction vehicles will not queue on public roads and cause congestion.

Vehicle set-down and turning areas on site will vary as the project progresses. They will, however, be located in relation to the vehicle access / egress points, and will be sized to ensure that there is sufficient space within the site to contain the vehicles without causing congestion to the public roads.

HGV movements to and from the site will be restricted to specific access routes primarily along the N4 and the Regional R292 routes.

14.7.1

3 C Local Environmental Protection The following mitigation and monitoring measures will be

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implemented to protect the local environment:

� Truck washing facilities will be provided at site entrance to ensure that mud and dust transfer onto the public road surface is minimised;

� Regular road sweeping will take place; � Trucks carrying demolition and excavated materials

will be covered as required to prevent spread of dust; � Suitable painted or graphically-covered hoarding

around site boundary will be provided; and � Pre-works survey of general condition of existing

access roads will be carried out so that the road network can be restored to its former condition after the construction period.

4 C

On-Site Facilities On site accommodation will consist of adequate materials drop-off and storage areas, as well as suitable internal turning area for trucks.

14.7.1

5 O

As outlined in section 13.4.4 Sligo Borough and Sligo County Council together with the National Roads Authority are progressing a number of road development projects. These improvements to the road network will neutralise any additional trips generated as a result of the proposed extension.

14.7.2

18.11 Waste

No. Stage Waste Commitments EIS Reference

1 O

Liquid Waste IPPC Licence The sanitary and process wastewater arising from the proposed extension will be managed under the EPA IPPC licence (P0090-01) for the existing facility which will be amended in agreement with the EPA to include waste arsing from the proposed extension. The IPPC licence shall be used to assess the environmental performance of the facility. Manufacturing Process and Containment Measures The vaccine manufacturing process involves the culture of Mycoplasma hyopneumoniae in a closed 1,000 litre

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stainless steel fermentor and then inactivating the whole cells so that they are innocuous, but still retain the physical surface properties that will enable them to create an immune response when injected into a pig. The inactivated whole cells comprise the sterile antigen. The culture must be separated from the environment during growth or it will become contaminated and unusable. The measures used to achieve this separation also ensure that the microorganism does not escape from the closed process equipment. The antigen is stored within the production suite until a test result indicates that the inactivation process has been successful. In summary, the process will produce a sterile bulk antigen, containing whole cells, which cannot be sterilised by filtration. It is therefore essential that the process is operated in an aseptic and axenic manner to prevent adventitious contamination from environmental organisms or process additions. This requirement also means that the environment within the facility will be free of the organism and its release from the facility very unlikely. However, the rooms in the suite where the cultures are grown are at a negative pressure to surrounding airlocks and the air leaving these areas is filtered through high efficiency particulate air (HEPA) filters. These will contain the organism within the building in the unlikely event of a spillage from the closed system that remains on the floor before it is disinfected. Waste that is potentially infected is autoclaved out of the antigen production suite and solid waste is bagged for disposal to landfill. Fire water will be collected from the suite and decontaminated chemically before being neutralised. The equipment and suite have been designed and will be commissioned and qualified to meet or exceed the requirements of Containment Level 2 (CL2) as defined in Draft Safety, Health and Welfare at Work (Biological Agents) Regulations 2010 and the current EC Directive and SI No. 248/1998. Any other microorganism species that requires this degree of separation and containment can also be used in the suite in the future.

2 O Site Drainage The proposed extension will be incorporated into the existing site drainage system, with new surface water, foul

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and process water lines constructed in the northern section of the site. See Figure 8.2 for the site drainage plan. The effluent will be combined and discharged with the existing facility effluent, into the local authority sewer.

3 O

Environmental Emergency Management Plan Elanco have already established a series of Standard Operating Procedures and Protocols for addressing with Environmental Emergencies. These Procedures and Protocols are predicated on protecting the receiving environment under all circumstances. The Elanco approach is clearly demonstrated by the extent of control and monitoring incorporated into the operation of the existing facility and this will be fully supported for the proposed extension by:

• The development of a comprehensive training

programme to ensure that operations staff are properly trained in the operation of the individual unit processes and in the identification of adverse trends which might indicate future problems;

• The incorporation of a detailed programme of preventative maintenance to ensure that all plant and equipment is maintained at optimal performance;

• The maintenance of an on-site inventory of spares and long delivery replacement equipment;

• Development of effective communication between production team leaders and Sligo WWTP operators;

• Simulation of breakdown and process failure situations to ensure that control systems are working properly; and

• On-going consultation with specialist process providers and industry specialists.

15.5.1

4 O

Notwithstanding the best endeavours of management and staff, incidents may occur which can impact the efficiency of the Sligo WWTP and towards this end Elanco will put in place a policy of:

• Recording all incidents; • Communicating all exceedances to Sligo Borough

Council; • Investigating all incidents (irrespective of how

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insignificant) which might have impacted the efficiency or integrity of the WWTP;

• Conducting “lessons learned” with all relevant staff following each such incident; and

• Review of Procedures and Protocols to incorporate the findings of the “lessons learned” where appropriate.

5 C

Solid Waste A site Waste Management Plan (WMP) will be developed during construction which will define a structured approach to the management, and recycling of waste onsite and identify licensed waste management contractors.

The WMP objective will be to provide better control of the regulatory risks relating to materials and wastes generated onsite with the result that any queries from the Environmental Protection Agency can be dealt with effectively. This will be prepared as per the Best Practice Guidelines Projects on the Preparation of Waste Management Plans for Construction and Demolition Projects which is available from the Department of Environment, Heritage and Local Government. These guidelines outline, among other recommendations, that waste can be minimised by:

• Ensuring the correct volume of materials is ordered

for the work to be undertaken and storing the materials appropriately to avoid contamination or deterioration;

• Co-ordinating with other contractors or developers in the supply of materials and services to avoid repeated deliveries or excavations; and

• Ensuring when preparing contracts for demolition and construction operations that clauses are included requiring the reuse of materials where practicable.

• The waste management plan will typically include: • The organisation of the contractor’s approach to

waste management including permit details etc; • the identification of disposal sites; • the identification of quantities to be excavated and

disposed of; • the identification of measures to prevent nuisance; • the identification of the amounts intended to be

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stored temporarily on site and the location of such storage;

• the identification of intended transport means for materials;

• procedures for dealing with Waste Management including liaison with third parties, statutory bodies, undertakers and other companies;

• procedures for the control of off-site activities associated with the Waste Management; and

• procedures for the management review/audits to monitor and demonstrate control over the implementation of the WMP.

6 O

The operational phase of the proposed extension will result in the generation of a range of hazardous and non hazardous wastes including sanitary and process waste water and a limited amount of cardboard, plastic and general waste.

The sanitary and process water arising from the proposed extension will be managed under the existing EPA IPPC licence (P0090-01) for the facility which will be amended in agreement with the EPA to include waste arsing from the proposed extension. The IPPC licence shall be used to manage the environmental performance of the facility.

15.6.4

18.12 Material Assets

No. Stage Material Assets Commitments EIS Reference

1 C/O

Extensions to utilities will be constructed in accordance with the requirement of the relevant utility companies (the ESB and Sligo County Council etc) to avoid /minimise disruption to their services.

16.6

2 C/O Onsite water consumption will continue to be monitored using water meters.

16.6

3 C/O

Wastewater discharges are limited to the volumes set out in the IPPC licence and will continue to be monitored as required under the IPPC licence.

16.6

4 C/O A monitoring programme will be introduced at each operational building unit for energy usage.

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