3. site and scheme description 3.2 plant location … · 3. site and scheme description ... the gum...

Pfizer Ireland Pharmaceuticals, D&n Laoghaire. Co. Dublin Aseptic Production Expansion EIS

3. SITE AND SCHEME DESCRIPTION

3.1 Introduction This chapter presents a description of the Aseptic Production Expansion Project. The existing operations and neighbouring land uses are also described.

3.2 Plant Location and History

The Pfzer Dublin Sterile Products Facility is located on Pottery Road, Dun Laoghaire. The site is approximately 12ktn to the southeast of Dublin City centre and 3.5kn.r southwest of the commercial centre of Dun Laoghaire. The general site location is shown in Figure 3.1 and the location on Pottery Road is shown in Figure 3.2.

Warner-Lambert Ireland Ltd was the original owner of the Pfizer Dublin Sterile Products Facility. Pfizer purchased Warner-Lambert Ireland Ltd in 2000. Pfizer Ireland Pharmaceuticals was formed at that time. The Warner-Lambert confectionery businesses were sold to Cadbury Schweppes and the pharmaceutical and health-care businesses were retained by Pfizer.

Warner-Lambert Ireland Ltd’s history in Dublin can be summarised as follows:

In 1956 it opened a distribution centre to supply its products to the Irish market.

In the early 1960s a manufacturing plant was established at Abbey Road, Blackrock, County Dublin. The company manufactured ethical and consumer products in this plant, which also functioned as a distribution depot, and employed 75 people.

In 1972 the company moved to the current location at Pottery Road, Dlin Laoghaire, when the Gum Base plant was opened. In 1973 a Finished Gum operation was established in the Gum Base building and employment increased to 300.

In 1976 the General Diagnostics Building was constructed on the Pottery Road site, resulting in an increase in employment to 500. This plant manufactured medical diagnostic reagents. Suites to manufacture the drug substances Elase and Thrombin were added to the General Diagnostics Building in 1980.

The Finished Gum operation ceased in 198 1 and General Diagnostics manufacturing ceased in 1984.

Aseptic production commenced in 1980.

Warner-Lambert Ireland Ltd purchased by Pfizer in 2000.

The gum base plant was leased to Cadbury Schweppes for three years.

3.3 Neighbouring Land Uses

Pottery Road forms the southwestern boundary of the site. The National Rehabilitation Hospital is located in extensive grounds which adjoin the site, to the north. Light industrial units and a sports ground are located to the northeast of the site. There is housing adjoining the site to the south and on the western side of Pottery Road. A number of small housing estates lie to the west of Pottery Road and are served by access roads from it. There are industrial plants on the western side of Pottery road, towards its northern end, close to its junction with Clonkeen Crescent. There are offices and laboratories for the Environmental Protection Agency to the south of the site and a petrol station further south, close to the junction of Pottery Road and Johnstown Avenue.

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Pfizer Ireland Pharmaceuticals, DGn Laoghaire, Co. Dublin Aseptic Production Expansion EIS

The general area is long established and has a wide range of uses. It is mainly residential but other uses include recreational and amenity, institutional, educational and commercial, as well as industrial.

3.4 Current Plant Layout and Facilities The site is circa 6.89ha in area (circa 17 acres). The complex currently comprises two main buildings, the pharmaceutical building and the gum base building, and a number of ancillary buildings and facilities. Figure 3.3 shows the existing site layout plan.

The pharmaceutical building is on three levels. Two production suites, the aseptic filling operation, the warehouse and the laboratories are on the first floor, plant rooms are on the second floor, and offices, canteen, staff facilities and utilities, such as water for injection and deionised water production, the boilers and one production suite, are on the ground floor.

The gum base building is single storey and accommodates manufacturing, warehouse and ancillary facilities.

Ancillary facilities include the security gate house at the site entrance, car and truck parking areas, single storey office accommodation, a switch room, cooling towers, emergency generator, waste storage compound, refrigeration units, nitrogen storage, waste water balancing and neutralisation plant, and firewater retention tanks.

To the east of the main buildings there are a car park and a hard standing area. The remainder of this area is in grass. Circa 3ha (7.5 acres) to the north of the existing facility is being purchased from the National Rehabilitation Hospital. This land currently is in pasture.

3.5 Current Site Production Facilities

Currently, there are two production activities in the complex. Finished pharmaceuticals are manufactured and formulated in the Pfizer plant and chewing gum base is manufactured in the Cadbury Schweppes gum base building.

Tthe primary focus of the Dublin plant is sterile manufacturing. Active pharmaceutical ingredients ( i.e. the ingredient in a drug which gives the therapeutic effect), sourced from other Pfizer plants in Ireland and overseas, are compounded in aqueous solutions, sterile filtered and filled into sterile glass vials, which range in size fi-om 2ml to 3Oml. Water for injection, which is water treated to achieve a very high standard of purity, is produced on site and used in the solutions. Some of the sterile liquid vials are freeze-dried. The filled vials are then either individually labelled and packed for distribution and sale, or packed in bulk cartons and sent to another Pfuer facility for later labelling and packing. The active pharmaceutical ingredient for a number of proprietary human pharmaceutical products are also manufactured in the Dublin plant, using a fractionation process to extract proteins.

Production operations are carried out with a very high level of control, in clean rooms, to protect the products from contamination. There is extensive sampling at every stage of the operation for quality assurance, and testing is undertaking in the site laboratories.

The production operations on site are batch operations. Very detailed equipment cleaning protocols are implemented between batches, using detergent and hot water, or isopropyl alcohol. Occasionally caustic soda is used as a cleaning agent. The sterile suites and other process areas are disinfected periodically.

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Pfizer Ireland Pharmaceuticals, Dlin Laoghaire, Co. Dublin Aseptic Production Expansion EIS

3.6 Main Features of the Expansion Project

3.6.1 Introduction

The Aseptic Production Expansion project will involve increasing the capacity of the existing aseptic production activity. This is the compounding of APIs made on site, or brought in from other Pfizer facilities, in aqueous solutions, filling into sterile glass vials, freezing-drying most of the vials, labelling and packaging.

The current aseptic production capacity is approximately seven million vials per annum. One of the new production modules will increase the capacity by circa fourteen million vials per annum, and the second module will increase the capacity by another fourteen million vials per annum, approximately. These are approximate numbers, as the actual numbers of vials produced depend on a large number of variables.

The activities will take place in clean room conditions.

Refer to Figure 3.4 for a schematic diagram of the production process.

3.6.2 New Buildings

The expansion will involve two main new buildings and ancillary facilities. There will also be modifications to the existing pharmaceutical building. The proposed site layout is shown in Figure 3.5. For full details on the buildings refer to the planning application drawings.

3.6.3 Production Modules 2 and 3 and Warehouse

This building will be located on the north-eastern side of the existing pharmaceutical building. The production modules will be circa 45m by 54m in plan and circa 19m in height to the main parapet level. The roof of the second floor plant rooms will extend approximately 5m above the main parapet level.

The ground floor of the two production modules will be at a level of approximately 39.4mOD, which will be approximately 2.4m above the ground floor level of the existing pharmaceutical building. The main parapet level of the two production modules will be at about 5.8m above the main parapet of the existing pharmaceutical building.

In the two production modules the ground floor level will be the main utilities level. Utilities and ancillary operations including the generation of purified water, water for injection and clean steam, the glycol system, the electrical substations, the uninterruptible power supply system, the equipment clean-in-place support systems, and the maintenance workshop and stores, will be located on the ground floor of these buildings.

The main production activities will take place on the first floor. The equipment and vial preparation and cleaning, active pharmaceutical ingredient compounding, vial filling, freeze drying, capping, and inspection operations will take place at this level. There will also be a series of spaces at this level for ancillary activities including staff changing and gowning rooms, stores, and staging. There will be two compounding suites, four freeze-dryers and two capping lines in each building.

Equipment and transfers will be in closed systems, by pumping or conveyor, to protect the product, and operations will be automated where feasible. Equipment will be cleaned using clean-in-place systems where feasible. Cleaning operations will use heat, hot water, detergents and caustic soda.

While there will be some controlled unclassified areas, most of the first floor will be clean rooms. There will be inner areas of grade B and the filling machine and the capping machines will be grade A clean room spaces. A grade A clean room is designed and operated to exclude micro organisms. The design and operation of graded clean rooms is specified in the

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Pfizer Ireland Pharmaceuticals, Wn Laoghaire, Co. Dublin Aseptic Production Expansion EIS

guidelines for manufacturing facilities published by the Irish Medicines Board.

The air handling and filtering plant for the clean room spaces will be located in the second floor plant rooms.

The warehouse area will be in the northern part of the building and will be circa 77Sm by 55.5m in plan. The main floor of the warehouse will be at a level of 43.37mOD. There will be pedestrian links from the warehouse area to production module 2 at this level.

The warehouse will accommodate the dispensing function, quality control inspection and sampling of incoming materials, as well as storage of incoming materials and outgoing product.

3.6.4 Laboratories and Canteen Building

This will be a two storey building with a penthouse plant room. It will be located at the north- western comer of the existing pharmaceutical building, to which it will be linked at ground floor and first floor levels. It will accommodate the main plant reception area, the staff canteen and locker rooms at ground floor level and process control laboratories at first floor level. The entire second floor will be a plant room.

The building will be L-shaped, with a road frontage of circa 35m and a depth of circa 46m. The main parapet will be approximately 2m higher than the parapet of the existing offices and the parapet of the plant room will be approximately lm higher than the parapet of the plant room of the existing pharmaceutical building.

There will be an enclosed walkway linking the laboratories and canteen building with the production module 2.

3.6.5 Security Building

The new security building will be located to the northwest of the existing gum base building, adjacent to the new main entrance. The building will accommodate a room for employee training as well as facilities for the site security staff to monitor and control all traftic to and from the site. It will be a small, single storey building with an irregular floor plan.

3.6.6 Central Utilities Building

The central utilities building will be approximately 36m by 19m in plan and two storeys in height. It will be located to the north of the gum base building. The ground floor will accommodate three boilers and an MV switch room. The first floor will accommodate the chillers, the boiler water treatment system, and an LV switch room. The exhaust stacks from the boilers, will project above the roof of the building. An emergency generator, and associated diesel storage tank, will be located to the south-east of the central utilities building. The cooling towers will be located to the southwest. This will serve process equipment in the new production modules as well as the existing production suites.

A pipe-rack will link the central utilities building with the warehouse,

3.6.7 Existing Facilities and Utilities to be Retained

The pump house and the water storage tank, which is located to the south of the existing pharmaceutical building and which is used for the storage of water for use in the process and for fire-fighting, will be retained. A pipe-rack will be erected from the pump house to the walkway, which will link the laboratories and canteen building to production module 2. The two tanks, which are for fire-water retention and which are located to the south of the pump house and water storage tank, will also be retained.

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Pfizer Ireland Pharmaceuticals, Dbn Laoghaire, Co. Dublin Aseptic Production Expansion EIS

3.6.8 Modifications to the Existing Pharmaceutical Building

The area on the ground floor of the existing pharmaceutical building, currently occupied by the canteen, kitchen and the reception area, will be used for conference and training rooms. The computer room on the ground floor will also be expanded. On the first floor, the warehouse functions of inspection, dispensing and storage will be relocated to the new warehouse and the space vacated will be used for the packaging operations and archive storage. The thrombin cold stores will be retained. There will be a glazed link from existing pharmaceutical building to the new laboratories and canteen building.

There are no specific plans, as part of the project, for a new use for the gum base building which will be vacated when the Cadbury Schweppes lease expires.

3.6.9 Site Works

The site works will include the removal of the existing car park and hard-standing area to the north-east of the existing pharmaceutical building. This area will be re-graded, which will involve the excavation of approximately 60,000m3 of soil. Much of this soil will be reused on site for landscape berms but approximately 20,000m3 will be disposed of off-site. Retaining walls will be constructed and berms formed. The parts of the site, affected by the expansion project, will be landscaped.

The temporary offices, to the front of the existing pharmaceutical building, will be removed.

The existing waste compound will be relocated and a new diesel-fired emergency generator will be installed in its place, close to the north-eastern comer of the existing pharmaceutical building. The existing waste water balancing plant, close to the eastern boundary, will become redundant. A new balancing plant, with capacity for both the existing and new production modules, will be installed near the north-eastern comer of the existing pharmaceutical building. A new nitrogen tank will be located close to the new balancing plant.

The area to the north of the gum base building will be re-graded, landscaped and a car park for 379 cars will be constructed.

The existing gatehouse will be removed and the existing main entrance realigned and a new main site entrance constructed.

3.7 Phasing of the Development It is proposed to construct the facilities in one phase. However, construction of production module 3 may be undertaken later than the other elements of the development.

3.8 Health, Safety and Environmental Aspects

3.8.1 Introduction

The management of the Pfizer Dublin Sterile Products Facility is committed to good environmental practice. Pfizer operates an Environmental, Health and Safety Management System and has procedures and equipment in place to respond to emergencies. The management system and procedures will be extended to the new facilities.

3.8.2 Site Environmental, Health and Safety Management System

The plant has a dedicated environmental, health and safety (EHS) department, which comprises the EHS Manager, EHS Administrator and an Environmental Officer. An occupational physician and an occupational health nurse, both of whom are on site part time, are also in the department.

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Pfizer Ireland Pharmaceuticals, D&I Laoghaire, Co. Dublin Aseptic Production Expansion EIS

The EHS department are responsible for the operation of the plant’s EHS Management System. EHS management meetings take place on a monthly basis to discuss the progress and performance of the EHS department, general EHS issues, compliance issues and the allocation of resources and responsibilities for completion of EHS objectives and targets.

The EHS Management System comprises seven key elements aimed at continuous improvement strategy.

A brief explanation of each of the seven elements within the EHS Management System is given below.

Organisation and Personnel

This element defines the following requirements within the EHS Management System:

l The definition and documentation of roles and responsibilities of all employees

l The training awareness and competence of all employees and contractors on site

l Procedures to be implemented to respond to internal and external queries relating to the Environmental Management System.

Iden@ Hazard

This includes the systematic identification of hazards within the workplace and the implementation of proper controls to minimise risks and maintain a safe working environment for all employees.

Operational Control

This element includes the requirement for documented procedures and work instructions for all activities within the facility. This includes operating criteria and the control of procurement and contracted activities. Every procedure written on site requires EHS agreement before it can be approved.

Management of Change

This includes the identification of potential incidents or environmental affects, which could result from any planned modifications or installations. This is controlled internally by the requirement for environmental, health and safety approval, either at management level or at corporate level, for all site capital purchase acquisitions and change note requests.

Planning for Emergencies

This involves the identification of potential accidents and the implementation of prevention and mitigation measures in the form of a site Emergency Plan and associated procedures. The periodic testing of these procedures and required dedicated training is included in this element.

Monitoring PerjTormance

The implementation of procedures to evaluate the performance of the facility against the environmental, health and safety objectives and targets as well as relevant regulatory and legislative requirements is an integral part of achieving continuous improvement within the Environmental Management System. The data obtained is combined with the data resulting from monthly departmental self-assessments and the annual environmental, health and safety self-assessment completed on site and is used to compile the EHS Plan for the following year.

Audit and Review

This examines the amalgamation of all elements of the management system in order to assess its overall success in achieving compliance with the Environmental Management System,

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Pfizer Ireland Pharmaceuticals, tin Laoghaire, Co. Dublin Aseptic Production Expansion EIS

management commitment, improvement of environmental performance, compliance to regulatory requirements and employee awareness and training.

3.8.3 Pfizer Ireland Pharmaceuticals Environmental, Health and Safety Policy

The Pfizer Ireland Pharmaceuticals Environmental, Health and Safety policy, which is implemented on the Pottery Road site, is as follows:

‘Consistent with our mission of improving the health and well-being ofpeople worldwide, Pfizer has long considered effective management of the natural and workplace environment to be one of our highest corporate priorities. We reaffirm that commitment and pledge our continued efforts to protect our communities and the environment.

We shall:

Seek continuous improvements in our environmental, health and safety per$ormance by.

Monitoring scientific and technical developments, and remaining sensitive to environmental, health and safety expectations and community needs;

Establishing corporate guidelines and model programs for conducting operations in a safe and environmentally sound manner, with legal requirements as the starting point;

Insuring the development and implementation of environmental, health and safety policies andprocedures at the group/divisional level that refrect the corporate guidelines; and

Measuring environmental, health and safety per$ormance through regular assessments of compliance with internal guidelines/procedures and external regulations.

Maintain safe and environmentally sound manufacturing operations by:

a Designing and developing facilities which are efficient in the use of energy, minimizing the generation of waste, and disposing of any residual materials safely and responsibly;

a Assessing and controlling environmental, health and safety impacts of existing operations, or before starting up a new project or facility, or before decommissioning an existing one;

0 Understanding the implications of waste materials generated by facility operations and modifying and/or controlling such operations to prevent adverse health effects or environmental degradation; and

e Developing and maintaining, where significant hazards exist, emergency preparedness plans in conjunction with local emergency services, relevant authorities, and the local communi&.

integrate environmental, health and safety considerations into our research andproduct development activities by.

a Continuing to investigate potential impacts on the natural and workplace environment of processes and products and the means of avoiding adverse impacts;

8 Developingproductpackaging which can be recycled or reused or disposed of safely;

a Contributing to the dissemination of safe and environmentally sound technologies and management methods, consistent with intellectual property rights; and

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Pfizer Ireland Pharmaceuticals, Wn Laoghaire, Co. Dublin Aseptic Production Expansion EIS

l Seeking environmental, health and safety improvement through technological development.

Contribute to the common eflort to protect the natural and workplace environment by:

l Educating, training, and motivating employees to conduct their activities in a safe and environmentally responsible manner;

l Advising purchasers and users, as appropriate, about the safe handling and disposal of our-products; and

l Supporting the formulation of responsible and scienttfkally valid business, governmental, and intergovernmentalprograms andpolicies that will enhance environmentalprotection and sustainable development.

Foster openness and dialogue with employees and the public by:

l Anticipating and responding to concerns about the potential impacts ofproducts, operations, or wastes on the natural or workplace environment. ’

3.8.4 Fire and Emergency Procedures

Measures and procedures are in place to prevent fires and emergency situations and to mitigate their effects.

The construction of the plant and buildings, and the materials used, comply with recognised standards and regulations for fire safety. The buildings are equipped with sprinkler systems as appropriate. There are fire hydrants located around the site. There is a comprehensive fire detection and alarm system through out the plant. Weekly checks are carried out on the fire protection systems, including the sprinkler system, fne water pumps, fire extinguishers, hydrants and fire hose reels.

There is a tank for the storage of water, to be used in fire-fighting, adjacent to the mains water pump house. The tank provides water for the sprinkler system in all process areas and offices, The water storage capacity is 1 680m3. Diesel powered pumps are provided for the tire- fighting water systems, to ensure that they are independent of the power supply.

The fire detection system is linked to the main alarm panel in the Maintenance Office. There is also an indicator panel in the Security Office, at the main gate. Security is maintained around the clock with site inspection rounds every two hours during nights and weekends. The on-call supervisor can be contacted by the security personnel outside normal office hours, should the need arise.

3.9 Regulatory Control of the Facility

The Pfizer Dublin Sterile Products Facility operates under an IPC Licence, Licence Number 19, granted by the Environmental Protection Agency. The plant requires an IPC Licence, under the 1992 EPA Act, in order to produce active pharmaceutical ingredients. The aseptic production activity, which is being expanded, does not require an IPC licence because it has a very low potential for environmental impact. However, once one activity on the site requires an IPC Licence, all activities on the site come within the scope of the licence.

The complete licence can be viewed on the EPA’s website www.epa.ie. The table of contents for the IPC licence is as follows:

1. Scope

2. Management of the Activity

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Pfizer Ireland Pharmaceuticals, Dtin Laoghaire, Co. Dublin Aseptic Production Expansion EIS

3. Interpretation

4. Notification

5. Emissions to Atmosphere

6. Emissions to Sewer

7. Wastes

8. Noise

9. Non-Process Water

10. Monitoring

11. Recording and Reporting

12. Emergency Response

13. Agency Charges

14. Sanitary Authority Charges

The licence requires the company to take various actions to meet its environmental obligations, particularly by monitoring emissions and reporting results to the EPA, maintaining the site environmental management programme, and continuing waste minimisation and the use of clean technology.

The Council Directive 96/6 1 /EC on Integrated Pollution Prevention and Control @‘PC) will be implemented in Ireland by Section 15 of the Protection of the Environmental Act 2003. The changes to the licensing framework will include an extension to the range of activities to be licensed and a greater emphasis on energy efficiency, residuals management and reducing natural resource consumption. As established activities have to be compliant with the Directive by October 2007, most IPC licences are likely to require review. This will also be the case with Pfizer’s licence. Under the Directive, IPPC licences are to be determined having regard to the principle of Best Available Techniques (BAT) which in turn are based on the Reference Documents on Best Available Techniques being developed for the various sectors by the EU.

3.10 Greenhouse Gas Emissions Permit

The member states of the EU, including Ireland, are signatories to the Kyoto Protocol, which requires reductions in emissions of greenhouse gases by specific amounts over a period from 2008 to 2012 and beyond. The EU has undertaken to reduce greenhouse gas emissions by 8% on average below 1990 levels. The EU Emissions Trading Directive (Directive 2003/87/EC) is being implemented to achieve this target.

The EPA is responsible for implementing the Emissions Trading Directive in Ireland. The Directive establishes an allowance-trading scheme for emissions to promote reductions of greenhouse gases, in particular carbon dioxide.

To implement the Directive, the EPA has developed a Greenhouse Gas Emissions Permit system. Installations covered by Annex 1 of the directive require a Greenhouse Gas Emissions Permit. Each installation will receive an allocation of greenhouse gas emissions at the beginning of each year. If there is a gap between this allocation and the actual emissions, the installations can buy or sell allowances anywhere in the EU.

Annex 1 of the Directive includes combustion installations with a rated thermal input exceeding 20 MW (except hazardous or municipal waste installations). The current installed capacity of the Pfizer Sterile Products Facility is circa 7.5MW. Following the expansion

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Pfizer Ireland Pharmaceuticals, Dbn Laoghaire, Co. Dublin Aseptic Production Expansion EIS

project the installed capacity will increase to 34.8MW. The expanded facility will then require Greenhouse Gas Emissions Permit.

3.11 Part 11 of the Planning and Development Regulations

Part 11 of the Planning and Development Regulations, SI 600 of 2001, sets down requirements for developments at establishments to which the European Council Directive 96/82/EC, on the Control of Major Accident Hazards Involving Dangerous Substances, applies. Part 11 does not apply the Pfizer Dublin Sterile Products Facility, currently, and will not apply to the extended facility.

3.12 Provision for Decommissioning

The proposed new facilities have a projected life span of 30 years, though this may be extended through upgrading or the replacement of equipment. Should circumstances arise whereby the plant becomes surplus to Pfizer’s requirements, Pfizer will endeavour to sell the facility as a going concern. If it became necessary to cease operations, Pfuer will implement a decommissioning programme to ensure that any negative environmental impact is minimised. The programme will include:

l Removal of any chemicals or materials stored on site. Any oils, lubricants or fuels that are on site at the time of closure will be recycled/disposed of through appropriate registered contractors.

l Plant, equipment and machinery will be emptied on ceasing operations, dismantled and stored under suitable conditions until sold, or if a suitable buyer cannot be located, recycled/disposed of through appropriate licensed waste disposal contractors.

l The plant buildings will be subject to thorough house cleaning procedures prior to final departure.

l The site and buildings will be left in a secure manner and appropriate security maintained on site in the event of the site potentially being vacant for an extended period of time.

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4.

4.1

PLANNING AND POLICY CONTEXT

Introduction This chapter presents a description of the planning and policy context of the proposed Pfizer Aseptic Production Expansion project. The proposed development has been examined in the context of the policies and objectives of the documents listed below:

National Policy Context

0 The National Spatial Strategy 2002-2020 People, Places and Potential, Department of the Environment and Local Government, Nov 2002

a Ireland-National Development Plan 2000-2006, Government of Ireland, 1999

o Sustainable Development - A Strategy fir Ireland, Department of the Environment and Local Government, 1999

e The National Climate Change Strategy, Department of the Environment and Local Government, October 2000

Local Policy Context

0 D&t Laoghaire-Rathdown County Development Plan 2004-2010

* Strategic Planning Guidelines for the Greater Dublin Area, March 1999 and Annual Review and Update for 2000,200 1 and 2002

e An Integrated Strategy for Social, Economic and Cultural Deveiopment 2002-2012, June 2002, D6n Laoghaire-Rathdown County Development Board

The expansion project complies with the relevant Irish Government policies, the relevant policies of the D6n Laoghaire-Rathdown County Development Plan and with the land use zoning for the site.

4.2 National Policy Context

4.2.1 The National Spatial Strategy 2002-2020 People, Piaces and Potential, Department of the Environment and Local Government, November 2002

The National Spatial Strategy is a 20-year national planning framework designed to achieve a better balance of social, economic and physical development and population growth between regions. The National Spatial Strategy recognises that much of Ireland’s recent prosperity has been generated in the Greater Dublin Area (which includes Dtin Laoghaire-Rathdown County) and that the performance of the Greater Dublin Area will remain pivotal to the overall economic well being of Ireland. It is recognised that the form of development in the Greater Dublin Area has created acute pressures in areas like traffic congestion and housing supply. The fundamental approach to the National Spatial Strategy is to encourage greater spatial balance by strengthening areas and places in a structural way rather than seeking to stop growth in Dublin. It is essential to the National Spatial Strategy that the past performance of the economy of the Greater Dublin Area and surrounding counties is built upon so that its success, competitiveness and national role are sustained into the future. The physical consolidation of Dublin, supported by effective land use policies for the urban area itself, is an essential requirement for a competitive Dublin.

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Pfizer Ireland Pharmaceuticals, Drin Laoghaire, Co. Dublin Aseptic Production Expansion EIS

Conformance of the Project to the Policy Objectives

The proposed development will be a beneficial element in consolidating the Dublin regions contribution to the overall national economic development. Pfizer’s investment signifies its commitment to expanding its operations to ensure that it remains competitive and continues to meet the highest quality standards.

4.2.2 Ireland - National Development Plan 2000 - 2006, Government of Ireland, 1999

The National Development Plan is designed to strengthen and improve on Ireland’s international competitiveness so as to support continued, but more balanced, economic and social development. The National Development Plan has four basic strategic objectives as follows:

l to continue sustainable national economic and employment growth,

l to strengthen and improve Ireland’s international competitiveness,

l to foster balanced regional development, and

0 to promote social inclusion.

The National Development Plan states that activity in the Productive Sector (which includes manufacturing industry), is essentially the driver of economic growth and as such is relied on to deliver jobs and wealth creation. The Plan notes that a primary focus of Ireland’s industrial policy in recent years has been to win the highest possible share of quality inward investment in, inter aZia, targeted manufacturing. In relation to Foreign Direct Investment, the strategy will aim to

“increase the value and sustainability of overseas companies in Ireland and secure their future in Ireland.... ”

The Plan states that the industrial development agencies will increasingly work with the existing base of foreign companies in Ireland to ensure that they become more embedded in the Irish economy and that they are constantly moving up the value chain in terms of their Irish operations.


The proposed development conforms to the policy objectives of the National Development Plan by helping to consolidate and build on the Region’s recent economic performance. A key element of the overall strategy of social inclusion is the continuation of sustainable economic growth to promote jobs. The proposed development will create employment in addition to increasing the level of Foreign Direct Investment in the Dublin region.

4.2.3 Sustainable Development-A Strategy for Ireland, Department of Environment and Local Government, 1999

The Department of Environment and Local Government published the Sustainable Development Strategy in 1997. The central aim of the Strategy is to provide a comprehensive analysis and framework that will ensure development is undertaken in a sustainable manner in Ireland. It also supports the commitment that Ireland made to sustainable development at the Earth Summit in Rio de Janeiro in 1992.

The Strategy acknowledges that multi-national companies represent a considerable proportion of the Irish industrial base and that these companies are required, and accustomed, to operate to high environmental standards. For industry, the overall objective of the Strategy is to ensure that development:

l is environmentally sound, maximising advantage and maintaining quality

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Ptizer Ireland Pharmaceuticals, Dlin Laoghaire, Co. Dublin Aseptic Production Expansion EIS

. optimises the use of natural resources

. minimises the production of waste and emissions

. uses chemicals and other substances with potentially adverse environmental impacts sparingly and safely, and

e has a strongly defined clean production and clean technology ethos.

In relation to industry’s interaction with the environment, the Plan states that it is essential for industry to recognise and address its potential for extensive impacts on the natural environment. However, it acknowledges that industrial emissions are, in general, well regulated. The minimisation of industrial wastes is a major objective of national policy, and the Plan states that measures such as cleaner production processes, life-cycle analysis and other eco-efficient approaches in the industrial sector will contribute to realising this objective.

The Plan says that public regulation and control have an important place in the environmental management of industry, but it also acknowledges that substantial complementary action can, and is, been taken by industry, both to minimise environmental impact and to increase efficiency. Progressive voluntary policies by industry can reduce the need for vigorous regulation, by, for example:

o participation in environmental management schemes

* the development of dedicated codes of practice to cover, for example, waste prevention and energy saving.


The proposed development conforms to the policy objectives of the Sustainable Development Strategy. The plant operation is regulated under an integrated pollution control licence @PC) from the EPA. This requires the company to undertake various actions to meet its environmental obligations, including ongoing efforts at waste minimisation and the implementation of clean technology. Pfizer is committed to an Environmental Management Programme and sets out environmental goals and objectives for the facility to achieve year- on-year improvements within each of the areas of environmental management stated in their IPC Licence.

The Pfizer Environmental Health and Safety Policy (to which Pfizer Pottery Road adheres, and which is quoted in Section 3.8.3 above) sets out a number of aims and objectives which relate to sustainable development including designing and developing facilities which are efficient in the use of energy, minimizing the generation of waste, disposing of any residual materials safely, and maintaining safe and environmentally sound manufacturing operations.

4.2.4 The National Chafe Change Strategy, Department of Environment and Local Government, October 2000

The National Climate Change Strategy, which was produced by the Government in October 2000, provides a framework for achieving greenhouse gas emission reductions, and has helped the country prepare for ratification of the Kyoto Protocol on 3 1 May 2002.

The main objectives of the Strategy are as follows:

. to meet Ireland’s legally binding commitments under the Kyoto Protocol, and

. to position Ireland to be able to adhere to potentially more stringent targets in the years following 20 12.

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Pfizer Ireland Pharmaceuticals, D&n Laoghaire, Co. Dublin Aseptic Production Expansion EIS

4.3


The heating requirements of the development will be met by natural gas. Natural gas is a fuel that generates less greenhouse gases than oil, peat or coal. Pfizer implements an environmental management system, which is described in Section 3.8.1 above. Achievements of the programme for 2003 included implementation of a refrigerant management programme and an energy reduction plan.

Local Policy and Planning Context

4.3.1 Dcin Laoghaire - Rathdown County Development P/an 2004-2010

The Dun Laoghaire-Rathdown County Development Plan outlines the aims and policies for future planning and development of the County. It was prepared in accordance with the requirements of the Local Government (Planning and Development) Act 2000 and Regulations 2001. The Plan was adopted in March 2004.

The general aims, objectives and policies of the County Development Plan are supportive of industrial development. Chapter 8 of the Plan is devoted to employment. The vision of the Plan in relation to employment is:

‘The vision of this Plan is to facilitate the creation of economic growth across a wide range of sectors in the County while fostering existing employment centres and realizing the potential of the knowledge economy. The generation of economic growth will be required to many with the principles of sustainable development. ’

The Plan was formulated

‘in the context of national and regional plans, policies and strategies. At national level these include the National Spatial Strategy 2002-2020, DOELG, 2002, Sustainable Development-A Strategy for Ireland, DOE, I997 and Ireland-National Development Plan 2000-2006, GOI, 1999. The regional context is provided by the Strategic Planning Guidelines for the Greater Dublin Area, 1999 and Strategy 2000-2016 A Platform for Change, DTO, 2001’

The strategy set out in the plan to achieve the vision is as follows:

’ The strategic vision of this Plan is to encourage the expansion of existing industries, to concentrate development into existing employment centres and to facilitate the growth of employment opportunities for the residents of the County, in a sustainable manner. The focus on employment creation will be based on consolidating the strong job generation capacity of high technology and knowledge based industries and the needfor starter/incubator units to promote small to medium enterprise. The attraction of these industries and other employment generators to the County will be facilitated by, the provision of a transportation infrastructure which will allow the efJicient movement of people and services throughout the County and which would promote modal change to public transport, cycling and walking, the provision of a communications infrastructure, including broadbandfacilities to support the knowledge industries, the enhancement of the existing high levels of educational attainment in the County and the availability of suficient zoned serviced lands. The need to ensure linkages between the employment centres and transportation hubs is an integral element of the plan and is one of the basic tenets of achieving the sustainable economic development of the County into the future. ’

The Plan states, in Policy E17, that

‘it is the policy of the Council to encourage the development of science and technology based enterprise in the county’.

In Policy E7, the Plan states that

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‘it is the policy of the Council to ensure that all economic activity in the County operates in accordance with current European and National environmental legislation. ’

Conformance of the Project to Policy Objectives

The proposed development conforms to the policy objectives of the Development Plan. It is an expansion of an existing employment centre. The existing plant and proposed expansion are science based, and utilise very advanced technology. The proposed development will operate in accordance with National and European environmental legislation and will not impact negatively on the surrounding areas. The expansion project has been designed to be sustainable and incorporates design features, which promote energy conservation, minimisation of the use of resources and protection of the environment.

4.3.2 Strategic Planning Guidelines for the Greater Dublin Area, March 1999 and Annual Review and Update for 2000,200l and 2002

The principal objective of the Guidelines is the provision of a broad planning framework for the Region including the future investment in transport, sanitary services and other infrastructure. The Guidelines propose a sustainable settlement strategy, which will offer choice in terms of residential and employment location and a much improved transportation system.

Conformance of the Project to Policy Objectives

The proposed development conforms to the policy objectives of the Strategic Planning Guidelines in general terms by helping to consolidate economic performance and to f&her the creation of sustainable employment in the area.

4.3.3 An Integrated Strategy for Social, Economic and Cultural Development 2002 - 2012, June 2002, Dbn Laoghaire - Rathdown County Development Board

In 1998, the Government established an Inter-Departmental Task Force to address the issue of the integration of Local Government and Local Development Systems. The Task Force recommended the establishment of County and City Development Boards, with the principal objective of each County and City Development Board being to prepare and implement a 1 O- year strategy relating to the economic, social, and cultural development of the county or city. The Dtin Laoghaire-Rathdown County Development Board was established in April 2000 and produced a Strategy document in 2002.

In relation to economic development, the Strategy states that the County already enjoys a successful economic growth pattern and embraces a diversity of economic activity. The Strategy states that a successful commercial base is fundamental to the county and is therefore designed to support educational, training and family support provision that will effect a positive change in the work-life balance.

The Strategy framework had regard to, for example the National Development Plan and the then forthcoming National Spatial Strategy and Development Plan. It was envisaged that the Strategy would provide significant contribution to the Development Plan in terms of sustainable spatial development and attracting new enterprise to the County whilst recognising the contribution of existing business organisations.


The proposed development will be located on an existing industrial site and will continue to f%rther sustainable economic development within the County.

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Pfizer Ireland Pharmaceuticals, tin Laoghaire, Co. Dublin Aseptic Production Expansion EIS

4.4 Planning and Development Evaluation

4.4.1 Site Zoning

The Pfizer site is zoned for industrial use in the County Development Plan. The land use zoning is Zone E - To provide for economic development and employment. In this zoning the following uses are permitted in principle:

‘Abattoir, Advertisements and Advertising Structures, Carpark, Cash & Carry/Wholesale Outlet, Creche/Nursery School, Enterprise Centre, Heavy Vehicle Park, Hospital, Household Fuel Depot, Industry-General, Industry-Light, Industry-Special, Motor Sales Outlet, Office Based Industry, Ofice less than 2OOsq.m, OfJices 200sq.m - I, OOOsq.m, OfJices over I, OOOsq.m , Open Space, Petrol Station, Public Services, Refuse Transfer Station, Retail Warehouse, Rural Industry-Food, Science and Technology Based Industry, Scrap Yard, Service Garage, Transport Depot, Traveilers Accommodation, Warehousing. ’

Figure 4.1 indicates the zoning of the site and surrounding area.

The Development Plan also includes general guidance on the County Council requirements in relation to design considerations in various development classes. These include features such as landscaping, screening, parking and access roads and drainage design. These requirements are addressed in the relevant chapters.


The proposed development conforms to the zoning specified in the County Development Plan.

4.5 References Department of Economic Development and Planning, Dun Laoghaire-Rathdown County Council Dun Lao&air-e-Rathdown County Develonment Plan 2004-20 10

Dublin and Mid-East Regional Authorities (1999 et seq.) Strategic Planning Guidelines for the Greater Dublin Area (March 1999 and Annual Review and Update for 2000) Dublin City Council and The Department of Environment and Local Government

Dun Laoghaire-Rathdown County Development Board (2002) An Integrated Strategv for Social. Economic and Cultural Development 2002-2012

Government of Ireland (1999) Ireland - National Development Plan 2000-2006 The Stationery Office, Dublin

Government of Ireland (1999) Sustainable Develonment - A Stratepv for Ireland The Stationery Office, Dublin

Government of Ireland (2000) The National Climate Change Strategy The Stationery Office, Dublin

Government of Ireland (2002) The National Saatial Stratew 2002-2020 People, Places and Potential The Stationery Office, Dublin

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Pfizer Ireland Pharmaceuticals, D&II Laoghaire, Co. Dublin Aseptic Production Expansion EIS

5. VISUAL IMPACT

5.1 Introduction This assessment of the landscape impact of the proposed development is made on the basis of the ‘Guidelines on Information to be Contained in Environmental Impact Statements’, prepared by the EPA in 2002. In particular, the assessment is made with regard to the visual impact of the development, the extent to which the development can be seen, and also with regard to the impact on the existing character of the suburban landscape.

The assessment was carried out by visiting the site and its surroundings in April 2004, by analysis of the proposals through plans, sections, aerial photographs and photomontages and by reference to the Dun Laoghaire-Rathdown County Development Plan 2004-2010. In order to assist in presenting the likely visibility of the proposed development, a number of photomontages representative of views from the surrounding areas have been included in the assessment. In each case the ‘as existing’ and ‘as proposed’ view is given.

5.2 Impact Significance

This criteria used in assessing level of impact is as suggested in the ‘Guidelines on Information to be Contained in Environmental Impact Statements’. The significance of impacts, which may be positive, neutral or negative are rated as follows:

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

Slight: An impact which causes noticeable changes in the character of the environment without affecting its sensitivities.

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

Significant: An impact which, by its character, magnitude, duration or intensity alters a sensitive aspect of the environment.

Profound: An impact which obliterates previous characteristics

Where positive, neutral or negative are defined as follows:

Neutral: A change which does not affect the quality of the environment.

Positive: A change which improves the quality of the environment.

Negative: A change which reduces the quality of the existing environment.

In terms of duration impacts may be:

Temporary: Impact lasting one year or less.

Short-term: Impact lasting one to seven years.

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