Pfizer Ireland Pharmaceuticals · 2019. 3. 7. · Pfizer Ireland Pharmaceuticals Building 3C-2 Development ... Directive 2011/92/EU, as amended 2014/52/EU (EIA Directive). ... by

Pfizer Ireland Pharmaceuticals

Building 3C-2 Development

Environmental Impact Assessment Screening Report

Final Issue | 28 February 2019

This report takes into account the particular

instructions and requirements of our client.

It is not intended for and should not be relied

upon by any third party and no responsibility

is undertaken to any third party.

Job number 264181-00-00

Ove Arup & Partners Ireland Ltd

Arup

50 Ringsend Road

Dublin 4

D04 T6X0

Ireland

www.arup.com

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Pfizer Ireland Pharmaceuticals Building 3C-2 Development Environmental Impact Assessment Screening Report

| Final Issue | 28 February 2019 | Arup

\\GLOBAL\EUROPE\DUBLIN\JOBS\264000\264181-00\4. INTERNAL\4-03 DESIGN\4-03-02 CONSULTING\IED APPLICATION\COMBINED LICENCE\5. STAKEHOLDER

ENGAGEMENT\EIA SCREENING\EIA SCREENING REPORT-FINAL 27022019REV.DOCX

Contents Page

1 Introduction 1

2 Legislation and Guidance 2

2.1 Introduction 2

2.2 Overview 2

2.3 EIA Directive 2014/52/EU 3

2.4 European Union (Planning and Development) (Environmental Impact Assessment) Regulations 2018 4

2.5 Planning and Development Acts 2000 to 2018 5

2.6 Planning and Development Regulations 2001 to 2018 5

2.7 EIA Screening Methodology 7

3 Background 11

3.1 Introduction 11

3.2 Background 11

3.3 Site and Context 13

4 Existing Environment 17

4.1 Introduction 17

4.2 Location of the Proposed Development 17

4.3 Existing Environment 17

5 Characteristics of the Proposed Development 44

5.1 Introduction 44

5.2 Overview 44

5.3 Construction Phase 45

5.4 Operational Phase 47

6 Characteristics of Potential Effects 50

6.1 Construction Phase 50

6.2 Operational Phase 56

7 Screening Checklist 65

8 Conclusions 76

9 References 78

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Page 1

1 Introduction

Arup has been appointed by Pfizer Ireland Pharmaceuticals to undertake an

Environmental Impact Assessment (EIA) Screening appraisal to determine

whether an EIA is required for development at the existing facility in Newbridge,

Co. Kildare.

The ‘proposed development’ as referred hereafter, will facilitate the introduction

of new production processes for the manufacture of Gastrointestinal Therapeutic

System (GITS) products, and to provide additional capacity at the existing

Technology Innovation Centre (TIC). This will involve the retrofitting of existing

buildings, including the installation of new processing equipment (as well as the

introduction of additional new particulate and solvent emission points),

installation of a number of additional penthouse louvres at roof level for the Air

Handling Unit (AHU) intake and exhaust, modification to the existing solvent

tank farm, the provision of two new tanks adjacent to Building 7, the installation

of two end-of-line Volatile Organic Compound (VOC) abatement units (thermal

oxidation) and one non-thermal end-of-line VOC abatement unit, for the treatment

of solvent vapour emissions, and the installation of a new steam boiler.

Kildare County Council, as the competent planning authority, have determined

that the proposed development constitutes ‘exempted development’ under Section

5 of the Planning and Development Act 2000 (as amended). This EIA Screening

Report was submitted to Kildare County Council to inform this determination.

The findings of this EIA Screening appraisal conclude that the proposed

development would not be likely to have significant effects on the environment.

Therefore, it is the view of Arup that an EIA is not required for the proposed

development.

This report forms part of the application for a revised Industrial Emissions (IE)

Licence, as issued by Pfizer Ireland Pharmaceuticals to the Environmental

Protection Agency (EPA) to take into account the proposed new production

processes at the existing Pfizer Newbridge facility.

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2 Legislation and Guidance

2.1 Introduction

This section describes the relevant European, national and local legislation and

guidance for this EIA Screening Report.

2.2 Overview

The current requirements for EIA are set out by the European Union in Council

Directive 2011/92/EU, as amended 2014/52/EU (EIA Directive). This legislation

guides member states on the assessment of the effects of certain public and private

projects on the environment.

The 2014 EIA Directive came into effect in May 2017 and was transposed into

Irish legislation as the European Union (Planning and Development)

(Environmental Impact Assessment) Regulations 2018 (S.I. No. 296 of 2018). In

Ireland, the requirements for EIA in relation to planning consents are specified in

Part X of the Planning and Development Act, 2000, as amended, and in Part 10 of

the Planning and Development Regulations, 2001, as amended. A review of this

legislation was undertaken for the purpose of this EIA screening report.

The following guidance and consultation documents have also been considered

during the preparation of this report:

• Department of Housing, Planning, Community and Local Government (2017) Transposition of 2014 EIA Directive (2014/52/EU) in the Land Use Planning and EPA Licencing Systems;

• Department of Housing, Planning, Community and Local Government (2017) Implementation of Directive 2014/52/EU on the effects of certain public and private projects on the environment (EIA Directive): Advice on the Administrative Provisions in Advance of Transposition;

• Department of the Environment, Community and Local Government (2013) Guidelines for Planning Authorities and An Bord Pleanála on carrying out Environmental Impact Assessment;

• Department of the Environment, Heritage and Local Government (2003) Environmental Effect Assessment (EIA) Guidance for Consent Authorities regarding Sub-Threshold Development;

• Environmental Protection Agency (2017) Revised Guidelines on the Information to be contained in Environmental Impact Statements (Draft August 2017);

• Environmental Protection Agency (2015) Advice Notes for Preparing Environmental Impact Statements Draft September 2015;

• Environmental Protection Agency (2003) Advice Notes on Current Practice in the Preparation of Environmental Impact Statements;

• Environmental Protection Agency (2002) Guidelines on the Information to be contained in Environmental Impact Statements; and

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• European Commission (2001) Guidance on EIA Screening.

2.3 EIA Directive 2014/52/EU

A European Directive for EIA has been in force since 1985 since the adoption of

Council Directive 85/337/EEC on the assessment of the effects of certain public

and private projects on the environment.

The EIA Directive of 1985 has been amended three times by Council Directives

97/11/EC, 2003/35/EC and 2009/31/EC. It was ultimately codified and repealed

by Council Directive 2011/92/EU on 13 December 2011. This Directive was

further amended in 2014 by Council Directive 2014/52/EU which sets out the

current requirements for member states on the assessment of the effects of certain

public and private projects on the environment.

The EIA Directive sets out the requirements of the EIA process, including

screening the need for an EIA. Projects listed in Annex I of the EIA Directive

require a mandatory EIA whilst projects listed in Annex II require screening to

determine as to whether an EIA is required.

Articles 4(4) and 4(5) of the EIA Directive set out the requirements for EIA

screening of Annex II projects as follows:

“4(4) Where Member States decide to require a determination for projects listed in Annex II,

the developer shall provide information on the characteristics of the project and its likely

significant effects on the environment. The detailed list of information to be provided is

specified in Annex IIA. The developer shall take into account, where relevant, the available

results of other relevant assessments of the effects on the environment carried out pursuant

to Union legislation other than this Directive. The developer may also provide a description

of any features of the project and/or measures envisaged to avoid or prevent what might

otherwise have been significant adverse effects on the environment.

4(5) The competent authority shall make its determination, on the basis of the information

provided by the developer in accordance with paragraph 4 taking into account, where

relevant, the results of preliminary verifications or assessments of the effects on the

environment carried out pursuant to Union legislation other than this Directive. The

determination shall be made available to the public and:

(a) where it is decided that an environmental effect assessment is required, state the main

reasons for requiring such assessment with reference to the relevant criteria listed in Annex

III; or

(b) where it is decided that an environmental effect assessment is not required, state the main

reasons for not requiring such assessment with reference to the relevant criteria listed in

Annex III, and, where proposed by the developer, state any features of the project and/or

measures envisaged to avoid or prevent what might otherwise have been significant adverse

effects on the environment.”

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2.4 European Union (Planning and Development)

(Environmental Impact Assessment) Regulations

2018

The European Union (Planning and Development) (Environmental Impact

Assessment) Regulations 2018 (SI No. 296 of 2018) transpose the requirements of

Directive 2014/52/EU, amending previous Directive 2011/52/EU, on the

assessment of the effects of certain public and private projects on the environment

(the EIA Directive) into planning law with effect from 1 September 2018.

Regard has also been had to the provisions of the Planning and Development Acts

2000 to 2018 and the Planning and Development Regulations 2001 to 2018 as

they apply now.

Section 172(1) of Part X of the Planning and Development Acts 2000 to 2018 states:

(1) An environmental impact assessment shall be carried out by the planning authority or the Board, as the case may be, in respect of an application for consent for proposed development where either—

(a) the proposed development would be of a class specified in—

(i) Part 1 of Schedule 5 of the Planning and Development Regulations 2001, and either—

(I) such development would equal or exceed, as the case may be, any relevant quantity, area or other limit specified in that Part, or

(II) no quantity, area or other limit is specified in that Part in respect of the development concerned, or

(ii) Part 2 of Schedule 5 of the Planning and Development Regulations 2001 and either—

(I) such development would equal or exceed, as the case may be, any relevant quantity, area or other limit specified in that Part, or

(II) no quantity, area or other limit is specified in that Part in respect of the development concerned, or

(b) (i) the proposed development would be of a class specified in Part 2 of Schedule 5 of the Planning and Development Regulations 2001 but does not equal or exceed, as the case may be, the relevant quantity, area or other limit specified in that Part, and

(ii) the planning authority or the Board, as the case may be, determines that the proposed development would be likely to have significant effects on the environment.]

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Page 5

Section 5(1) of the Planning and Development Acts 2000 to 2018 provides that:

“If any question arises as to what, in any particular case, is or is not development or is or is not exempted development within the meaning of this Act, any person may, on payment of the prescribed fee, request in writing from the relevant planning authority a declaration on that question, and that person shall provide to the planning authority any information necessary to enable the authority to make its decision on the matter.”

2.5 Planning and Development Acts 2000 to 2018

As noted in Section 2.2, the current requirements for EIA in Ireland are outlined

in Part X of the Planning and Development Acts 2000 to 2018 and in Part 10 of

the Planning and Development Regulations 2001 to 2018.

Section 4(4) of the Planning and Development Acts 2000 to 2018 and Article 9 of the Planning and Development Regulations 2001 and 2018 provide that certain development, including development of the kind the subject of this Report, shall not be exempted development if it gives rise to a need for EIA.

Kildare County Council, as the competent planning authority, have determined

that the proposed development constitutes ‘exempted development’ under Section

5 of the Planning and Development Act 2000 (as amended). This AA Screening

Report was submitted to Kildare County Council to inform this determination.

2.6 Planning and Development Regulations 2001 to

2018

The prescribed classes of development and thresholds that trigger the need for an EIA are set out in Schedule 5 of the Planning and Development (Amendment) Regulations 2001 – 2018.

Section 2.5 of this report defines the criteria whereby a mandatory EIA is required, under the Planning and Development Acts 2000 to 2018, relevant to the class of developments listed under Part 1 and Part 2 of Schedule 5 of the Planning and Development Regulations 2001 to 2018.

A review of the classes of development listed under Part 1 and Part 2 of Schedule 5 of the Planning and Development Regulations 2001 to 2018 was therefore carried out to determine whether the proposed development falls into any of the development classes which require an EIA.

The proposed development does not relate to any of the development classes outlined in Part 1 of Schedule 5 and as such, there is no requirement to carry out a mandatory EIA. Similarly, the proposed development does not relate to any of the development classes outlined in Part 2, Schedule 5.

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However, Section 15 of Part 2, Schedule 5 sets out the requirement for EIA Screening where “Any project listed in this Part [Part 2] which does not exceed a quantity, area or other limit specified in this Part [Part 2] in respect of the relevant class of development but which would be likely to have significant effects on the environment, having regard to the criteria set out in Schedule 7.” This is referred to as ‘sub-threshold development.’

Section 92 of the Planning and Development (Amendment) Regulations 2001-2018 defines sub-threshold development as ‘development of a type set out in Schedule 5 which does not exceed a quantity, area or other limit specified in that Schedule in respect of the relevant class of development.’

The existing Pfizer Newbridge facility is considered to be a class of development described under Section 10(b)(iv) of Part 2, Schedule 5 of the Planning and Development (Amendment) Regulations 2001 – 2018:

10.Infrastructure projects

(a) Industrial estate development projects, where the area would exceed 15 hectares.

(b) (i) Construction of more than 500 dwelling units.

(ii) Construction of a car-park providing more than 400 spaces, other than a car-park provided as part of, and incidental to the primary purpose of, a development.

(iii) Construction of a shopping centre with a gross floor space exceeding 10,000 square metres.

(iv) Urban development which would involve an area greater than 2 hectares in the case of a business district, 10 hectares in the case of other parts of a built-up area and 20 hectares elsewhere.

(In this paragraph, “business district” means a district within a city or town in which the predominant land use is retail or commercial use.)

The proposed development relates to an increase in production at the Pfizer Newbridge facility of approximately 9%. As the existing Pfizer Newbridge facility is considered to be a class of development described under Section 10(b)(iv) of Part 2, Schedule 5, it has therefore been determined that the proposed development could be considered ‘sub-threshold development’ with regards to Section 13(ii) of Part 2, Schedule 5, whereby:

“13. Changes, extensions, development and testing

(a) Any change or extension of development already authorised, executed or in the process of being executed (not being a change or extension referred to in Part 1) which would:

(i) result in the development being of a class listed in Part 1 or paragraphs 1 to 12 of Part 2 of this Schedule, and

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Page 7

(ii) result in an increase in size greater than - 25 per cent, or - an amount equal to 50 per cent of the appropriate threshold, whichever is the greater.”

As such, under the provisions of Section 15 of Part 2, Schedule 5 of the Planning and Development (Amendment) Regulations 2001 – 2018, an assessment is required to determine the likely significant effects of the proposed development, and the subsequent need for an EIA.

2.7 EIA Screening Methodology

2.7.1 Overview

This EIA Screening Report, to facilitate an assessment of the ‘likely significant

effects’ of the proposed development, has been prepared in accordance with

Annex IIA and Annex III of the EIA Directive and Schedule 7 and Schedule 7A

of the Planning and Development (Amendment) Regulations 2001 – 2018.

2.7.2 Requirements of the EIA Directive

Annex IIA of the EIA Directive outlines the information that is required from the

developer to enable the competent authority to determine the need for an EIA.

This is set out in Article 4(4) of the EIA Directive, which states that:

“Where Member States decide to require a determination for projects

listed in Annex II, the developer shall provide information on the

characteristics of the project and its likely significant effects on the

environment. The detailed list of information to be provided is specified in

Annex IIA.”

Annex III of the 2014 EIA Directive outlines criteria for determining whether a

development is likely to have significant effects on the environment. This is set

out in Article 5(5a) which states that:

“(a) where it is decided that an environmental impact assessment is

required, state the main reasons for requiring such assessment with

reference to the relevant criteria listed in Annex III; or

(b) where it is decided that an environmental impact assessment is not

required, state the main reasons for not requiring such assessment with

reference to the relevant criteria listed in Annex III, and, where proposed

by the developer, state any features of the project and/or measures

envisaged to avoid or prevent what might otherwise have been significant

adverse effects on the environment.”

Discretion is given to member states in determining the need for an EIA, in

respect of Annex II projects. As such, the relevant Irish legislation and associated

guidance is pertinent for this EIA screening report, as detailed in Section 2.6.3

below.

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2.7.3 Irish Guidance

The criteria outlined in Annex IIA of the EIA Directive (i.e. for determining the

information that is required from the developer to enable the competent authority

to determine the need for an EIA) have been transposed into Irish legislation

through Schedule 7A of the Planning and Development (Amendment)

Regulations 2001 – 2018. Table 2.1 identifies the criteria outlined in Schedule 7A

and demonstrates where these requirements have been addressed in this screening

report.

Table 2.1: Criteria outlined in Schedule 7A of the Planning and Development

(Amendment) Regulations 2001-2018

Schedule 7A requirements Relevant section of this

screening report

1. A description of the proposed development, including in

particular:

(a) a description of the physical characteristics of the

whole proposed development and, where relevant, of

demolition works; and

(b) a description of the location of the proposed

development, with particular regard to the

environmental sensitivity of geographical areas likely

to be affected.

Section 5

Section 4 and Section 6

2. A description of the aspects of the environment likely to be

significantly affected by the proposed development.

Section 5 and Section 6

3. A description of any likely significant effects, to the extent

of the information available on such effects, of the

proposed development on the environment resulting from:

(a) the expected residues and emissions and the production

of waste, where relevant; and

(b) the use of natural resources, in particular soil, land,

water and biodiversity.

Section 6

The criteria outlined in Annex III of the EIA Directive, (i.e. for determining

whether a development is likely to have significant effects on the environment)

have been transposed into Irish legislation through Schedule 7 of the Planning and

Development (Amendment) Regulations 2001 – 2018. Table 2.2 identifies the

criteria outlined in Schedule 7.

Table 2.2: Criteria outlined in Schedule 7 of the Planning and Development

(Amendment) Regulations 2001-2018

Characteristics of proposed development

The characteristics of proposed development, in particular-

(a) the size and design of the whole of the proposed development,

(b) cumulation with other existing development and/or development the subject of a consent for

proposed development for the purposes of section 172(1A) (b) of the Act and/or development

the subject of any development consent for the purposes of the Environmental Impact

Assessment Directive by or under any other enactment,

(c) the nature of any associated demolition works,

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Page 9

(d) the use of natural resources, in particular land, soil, water and biodiversity,

(e) the production of waste,

(f) pollution and nuisances,

(g) the risk of major accidents, and/or disasters which are relevant to the

project concerned, including those caused by climate change, in

accordance with scientific knowledge, and

(h) the risks to human health (for example, due to water contamination

or air pollution).

Location of proposed development

The environmental sensitivity of geographical areas likely to be affected by the

proposed development, with particular regard to—

(a) the existing and approved land use,

(b) the relative abundance, availability, quality and regenerative capacity

of natural resources (including soil, land, water and biodiversity) in

the area and its underground,

(c) the absorption capacity of the natural environment, paying particular attention to the

following areas:

(i) wetlands, riparian areas, river mouths;

(ii) coastal zones and the marine environment;

(iii) mountain and forest areas;

(iv) nature reserves and parks;

(v) areas classified or protected under legislation, including Natura 2000 areas designated

pursuant to the Habitats Directive and the Birds Directive and;

(vi) areas in which there has already been a failure to meet the environmental quality standards

laid down in legislation of the European Union and relevant to the project, or in which it is

considered that there is such a failure; (vii) densely populated areas;

Type and characteristics of the potential impacts

The likely significant effects on the environment of proposed development in relation to criteria

set out under paragraphs 1 and 2, with regard to the impact of the project on the factors

specified in paragraph (b)(i)(I) to (V) of the definition of ‘environmental impact assessment

report’ in section 171A of the Act, taking into account—

(a) the magnitude and spatial extent of the impact (for example,

geographical area and size of the population likely to be affected),

(b) the nature of the impact,

(c) the transboundary nature of the impact,

(d) the intensity and complexity of the impact,

(e) the probability of the impact,

(f) the expected onset, duration, frequency and reversibility of the impact

(g) the cumulation of the impact with the impact of other existing and/or development the

subject of a consent for proposed development for the purposes of section 172(1A) (b) of the

Act and/or development the subject of any development consent for the purposes of the

Environmental Impact Assessment Directive by or under any other enactment, and

(h) the possibility of effectively reducing the impact.

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For the purpose of this EIA Screening Report, the criteria outlined in Schedule 7

of the Planning and Development (Amendment) Regulations 2001 – 2018 are

grouped under the following three headings, which are individually addressed in

the following sections:

(i) Characteristics of proposed development (Section 5);

(ii) Location of proposed developments (Section 4); and

(iii) Characteristics of potential effects (Section 6).

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3 Background

3.1 Introduction

The Pfizer Ireland Pharmaceuticals (formerly Wyeth Medica Ireland) Newbridge

facility, is a pharmaceutical production facility.

The Pfizer Newbridge facility was established in County Kildare in 1992. Since

then, successive expansions have seen the site grow from 40 to over 120 acres in a

facility of over 1,000,000 sq. ft. making it one of Europe's largest manufacturers

of solid dose pharmaceuticals. Today, Pfizer Newbridge is a centre of excellence

for the global and regional supply of established products as well as a

manufacturer for new and innovative therapies that are currently in the research

and development pipeline.

Since 2006, over €350 million has been invested in Pfizer Newbridge to expand

its development and manufacturing capabilities. The facility currently supplies

over 80 product formulations across a wide range of product categories including

central nervous system, hormone therapy and oral contraceptives to more than 100

markets around the world.

This Section provides a description of existing site and operations at the Pfizer

facility in Newbridge.

3.2 Background

The Pfizer Newbridge site was previously owned by AHP Manufacturing B.V.

(Netherlands) (trading as Wyeth Medica Ireland). Wyeth Medica obtained

planning permission from Kildare County Council in 1992 to develop the lands,

formerly owned by the Polaroid Corporation, as tablet making and packaging

facility, with the construction being carried out in 1993.

Having obtained planning permission from Kildare County Council to expand the

facility, Wyeth Medica applied for an Integrated Pollution Control (IPC) licence

in July 1996 as the expansion plans meant that the company would now use in

excess of ten tonnes per annum of organic solvents in coating processes. The IPC

Licence (Reg. No. P0153-01) was issued on the 14th January 1997.

This licence was revised on the 27th March 1998 (Reg. No. P0153-02) to take into

account the installation of new emission points to the atmosphere, allowing the

use of new pharmaceutical compounds in the manufacture of new products, and

minor amendments to the emissions to sewer.

A further revised IPC Licence (Reg. No. P0153-03) was issued on the 15th

February 2002 in relation to proposed changes to result in 12 additional emissions

to atmosphere from the process, installation of back-up steam boilers, and a

revision of the emission limit values (ELVs) for existing emission points.

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In 2004, Wyeth Medica was issued with a further revised licence (Reg. No.

P0153-04) to take into account the proposed expansion of their production

facilities.

This expansion involved the installation of a new bulk solvent tank farm

containing 6 No. 30m3 solvent tanks and additional utilities. This review of the

licence resulted in the installation being classified under Class 12.2.1, due to the

use of over 200 tonnes per annum of solvent in coating processes.

This licence was revised, as an Integrated Pollution Prevention Control (IPPC)

Licence, on the 20th October 2006 (Reg. No. P0153-05) to take into account the

installation of new emission points to the atmosphere for the manufacture of new

products, and utilities to support the associated manufacturing processes (boilers,

wastewater pre-treatment plant, waste management compound).

The IPPC Licence (Re. No. P0153-05) was transferred to Pfizer Ireland

Pharmaceuticals from AHP Manufacturing B.V. t/a Wyeth Medica Ireland on the

25th January 2011.

An Environmental Protection Agency (EPA) review of the licence was conducted

in 2013 in order to determine whether the IPPC licence could be brought into

conformity with the provisions and requirements of the Industrial Emissions (IE)

Directive Council Directive 2010/75/EU). Following this review, the EPA was

satisfied that the conditions of the existing IPPC Licence (P0153-05) fulfilled the

requirements of the IE Directive.

Over the period September 2007 to October 2017 a number of Technical

Amendments to Licence P0153-05 (to facilitate changes to existing emission

points to the atmosphere) have been approved by the EPA (at the time of writing

the latest approved Technical Amendment is ‘J’ and 2 Technical Amendment

submissions are currently undergoing review by the EPA). On the 6th April 2016,

the EPA amended (Clerical/Technical Amendment I) IE Licence Reg. No. P0153-

05. This amendment changed the name of the licence from an IPPC Licence to an

IE Licence. The amendment also introduced some new conditions, mainly related

to the reporting of environmental incidents. The IE Licence (P0153-05) is now

read in conjunction with the above-mentioned amendments.

The Pfizer Newbridge facility’s existing IE Licence currently permits the

following activities:

Class 12.2.1 The surface treatment of products using organic solvents in

particular for printing, coating, with a consumption capacity of

more than 200 tonnes per year.

Facility operations are based on formulation activities, consisting of the blending

of raw materials, granulation, drying and coating processes, with subsequent

filling and packaging operations and product distribution from the site.

Pfizer Ireland Pharmaceuticals intends to apply to the EPA for a revision to its

current IE licence to accommodate the proposed changes on site as outlined herein

(Section 5).

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3.3 Site and Context

The Pfizer facility at Newbridge is located within the townland of Little Connell,

northeast of Newbridge town centre and adjacent to the R445 as shown on Figure

3.1.

Figure 3.1: Site Location (Source: Bing Maps. Site indicated as red dot)

The current Pfizer Newbridge landholding consists of 48.6 hectares, of which

approximately 60% is utilised for production facilities, wastewater treatment

plants and waste storage areas. The remainder is used for internal access roads, car

parking and green space.

The facility is currently accessed from the R445 dual carriageway via a

roundabout and single access road. The existing development within the Pfizer

Newbridge site is located principally within the north-western area, with

undeveloped space located in the southern and eastern margins of the lands. These

undeveloped lands are largely Greenfield, comprised of agricultural and

landscaped grasslands.

The surrounding land use in the vicinity of the site is a combination of agricultural

and residential with neighbouring land use comprising stud farms to the north and

west of the site, a supermarket (Lidl) distribution centre to the south-east of the

site, agricultural land to the east (where expansion of the supermarket distribution

centre is currently taking place) and residential areas to the west of the site.

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3.3.1 Existing Pfizer Newbridge Facility

There are 2 main Primary Production Units (PPUs) on the Pfizer Newbridge site,

namely Pharma and Speciality Health Care, in which Pfizer perform a variety of

operations required for the manufacture of pharmaceutical products. The main

production buildings are 3, 3A, 3B, 3C and 4, with a packaging area (Building 2)

and other facilities comprising of solvent recovery plant, boilers and Combined

Heat & Power (CHP) plant and laboratories. There is also a pilot plant facility

(referred to the Technology Innovation Centre; effectively 1/10 scale of the

manufacturing processes) which supports future technical/technological

developments/requirements. Figure 3.2 provides an overview of the main

production buildings on site.

Other facilities include warehousing (of raw materials, intermediates and finished

goods), external materials storage, utility services including steam, compressed

air, nitrogen, cooling water and process water, electrical substation compounds, a

Wastewater Pre-Treatment Plant (main WWTP for the treatment of API from the

process wastewater), Oils Fats & Grease Wastewater -Treatment Plant (OFG

WWTP for the treatment of wastewater from the canteen which in turn discharges

to the main WWTP), engineering workshops, a contractors compound,

administration office buildings and canteen.

Figure 3.2: Overview of the Pfizer Newbridge Site

3.3.2 Process Operations

As outlined in Section 3.1, the manufacture of solid dose pharmaceutical products

at Pfizer Newbridge is based on formulation activities, consisting of the blending

of raw materials, granulation, drying and coating processes, with subsequent

filling and packaging operations and product distribution from the site.

Pfizer manufactures tablets and capsules in the Pharma and Speciality Health Care

PPUS for the following major product groups:

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• Pharma (non-hormonal products): Anti-depressant (Efexor), Central Nervous

System (CNS) treatment, Novel Oral Anticoagulants and

Immunosuppressants; and,

• Speciality Health Care (hormonal products): Hormone Therapy (HT),

Menopausal Hormone Therapy (MHT) and Oral Contraceptives (OC);

While the manufacturing operations may vary depending on the product

specifications, the following are the general unit operations undertaken at the

Pfizer Newbridge facility:

1. Dispensing

2. Sieving

3. Milling

4. Granulation

5. Drying

6. Blending

7. Spheronization

8. Coating (aqueous & solvent)

9. Compression

10. Encapsulation

11. Sorting

12. Printing

13. Inspection

14. Polishing

15. Packaging

The existing facility comprises over 100 No. main dust emission points, 7 No.

main solvent emission points, 8 No. boiler (including CHP) emission points, 1 No.

combined trade & foul wastewater drainage point and 1 No. surface water (storm

water) drainage point. All processes and associated emissions are, where

applicable, designed/treated in accordance with Best Available Technology (BAT)

principles in order to ensure compliance with the IE Licence Emissions Limit

Values (ELV), which in turn ensures that inputs to, and subsequent contamination

of the ambient environment does not occur during normal and/or emergency

conditions e.g.

• Particulate Dust emissions: High Efficiency Particulate Air (HEPA) filtration;

• VOC Emissions: Condensing/Absorption System for Efexor process;

• Wastewater Discharge: Wastewater Pre-Treatment Plant for the removal of

API from the wastewater (refer to Section 4.3.4.2).

3.3.3 Environmental Management Systems

Pfizer operates an integrated approach to the management of environmental

aspects of the site, and environmental protection and compliance has always been

a key consideration. Since operations commenced, the site has operated under the

former IPPC and now IE licensing system. The site environmental management

system (EMS) is certified to the international standard ISO14001. The

environmental management system is based on a combination of technical

measures and documented environmental management programmes and

procedures, whose objectives include:

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• Complying with all environmental legislation including the requirements of

the site IE licence;

• Eliminating the risk of accidental events which could give rise to significant

releases to the environment; and

• On-going continuous improvement of site environmental performance.

In addition, the Pfizer Newbridge facility has developed its Environmental and

Energy Management Systems based on the requirements of ISO system standards.

In March 2006 Pfizer Newbridge signed an agreement with the Sustainable

Energy Authority of Ireland (SEAI) to put a certified energy-management system

in place. This Energy Management System puts a structure around how the

Newbridge facility manages its energy and helps to identify and minimise the sites

energy consumption. The Pfizer Energy Management System is certified to the

international standard ISO50001.

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4 Existing Environment

4.1 Introduction

This section describes the location of the proposed development with particular

regard to environmental sensitivities on site and in the surrounding area (the

‘existing environment’).

4.2 Location of the Proposed Development

The proposed development is located at the existing Pfizer facility in Newbridge,

Co. Kildare, as described in Section 3.3.

The proposed development will be take place entirely within the existing envelope

of the existing Pfizer Newbridge facility (Refer to Figure 3.1 and Figure 3.2).

4.3 Existing Environment

4.3.1 Population and Human Health

4.3.1.1 Baseline Environment- Population

Kildare is one of the most populated counties in the State and has the fifth highest

population of all local authorities in Ireland.

Kildare has experienced a major and consistent expansion of its population in

recent years. Over a 20-year period (1991 to 2011), Kildare experienced a 71.5%

increase in its population base. This expansion is the result of both a high birth

rate and high levels of inward migration into the county.

The proposed development is located in Newbridge Municipal District. According

to the Central Statistics Office (CSO), the population of the Newbridge Municipal

District was 52,861 in 2016, representing a population increase of 5.5% since

2011.

With regards to principal economic status, some 55% of the population reported

themselves as being ‘at work’, with 7.9% of the population reporting themselves

as being unemployed. Of the population of the municipal district who are at work,

the largest reported employment industry was that of ‘commerce and trade.’ Some

12.3% of the population of the municipal district are employed in ‘manufacturing

industries.’

Some 59% of the population of the municipal district reported that their journey

time to work, school or college was less than 30 minutes.

The proposed development is further located in the Electoral Division ‘081

Oldconnell.’ The Electoral Division of Oldconnell is shown in Figure 4.1.

According to the 2016 CSO results, the total population of Oldconnell was 983 in

2016. This represents a population increase of 8.7% since 2011.

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Figure 4.1: Electoral Division of Oldconnell

4.3.1.2 On-site Operations-Population

The Pfizer Newbridge site operates 24 hours per day, 5 days per week, with up to

750 employees on site. There are currently limited production activities over the

weekend period.

4.3.1.3 Baseline Environment- Human Health

The 2016 Census results provides information on the self-perceived health status

of the country. Table 4.1 outlines the self-perceived health status of the

population living within the Municipal District of Newbridge. Some 87.5% of the

population of Newbridge Municipal District rated their health as either ‘very

good’ or ‘good.’

Table 4.1: Self-Perceived Health Status of the population of Newbridge MD

According to the 2016 Census, some 7,178 people in the Municipal District have

a disability, representing 13.6% of the total population.

The EPA ENVision Webmapper was reviewed in order to determine the risk of

the existing Pfizer Newbridge site to exposure to Radon. According to the EPA,

between 1 and 5% of the homes in this 10km grid square are estimated to be

subject to radon concentrations in excess of the national Reference Level of 200

bequerel per cubic metre (Bq/m3).

It is the policy of Pfizer Ireland Pharmaceuticals to conduct its business

responsibly and in a manner designed to protect the health and safety of its

employees, customers, the public and the environment.

Municipal

District

Very

good

Good Fair Bad Very bad Not stated

Newbridge 31,754 14,384 4,097 732 160 1,591

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Pfizer is conscious of the environmental health and safety regulatory requirements

which apply to its activities and has taken necessary measures to ensure

compliance with these requirements. Pfizer continue to comply with the spirit as

well as the letter of national and local laws and regulations relating to

environmental health and safety of employees.

Although other environmental legislation is also of relevance to the Pfizer

Newbridge site, the sites existing IE Licence is the key regulatory tool applied to

the site and its operations. The licence covers a wide range of environmental

issues relevant to site operations, including discharges to water, emissions to air,

waste management and disposal. The licence sets conditions under which the site

must operate, including quantitative limits on discharges to air and water and

more general duties such as monitoring and reporting.

4.3.2 Biodiversity

Newbridge Municipal District enjoys a unique geographical setting which creates

an unrivalled urban context.

The town is surrounded by The Curragh to the south and west, Mouds Bog and

Pollardstown Fen to the north and northwest, the River Liffey to the east. There

are also a number of open urban spaces throughout the area, the largest being an

8-ha park (20 acres) linking the developments of Lakeside, Dara Park and

Highfield. A number of large stud farms are also located along key approaches

from Naas and Kildare.

Tree lines and hedgerows are important components of Newbridge’s ecological

networks, allowing for linkages between and within designated ecological sites

and the non-designated surrounding countryside.

The existing Pfizer site at Newbridge consists of buildings and artificial surfaces

with limited biodiversity. The site is surrounded by agricultural and amenity

grassland and is bound by Newbridge Town to the east. Within the town of

Newbridge, there is a central dominance of buildings and artificial surfaces and

many of the buildings are surrounded by gardens.

Detailed habitat mapping for Newbridge was prepared by RPS as part of the

Strategic Environmental Assessment of the Newbridge Local Area Plan 2013 –

2019. The map is reproduced in Figure 4.2, with the Pfizer Newbridge site

indicated as a ‘black dot’.

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Figure 4.2: Newbridge Habitat Mapping (Source: Strategic Environmental Assessment of the Newbridge Local Area Plan 2013-2019) (the Pfizer

facility is indicated with a ‘black dot’

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Special Areas of Conservation (SACs) have been selected for protection under the

European Council Directive on the conservation of natural habitats and of wild

fauna and flora (92/43/EEC) - referred to as the Habitats Directive.

Natural Heritage Areas (NHA’s) are a national network of sites selected for the

conservation and protection of nationally important plant and animal species and

their habitats.

They are also designated to conserve and protect nationally important landforms,

geological or geomorphological features. The legal basis for NHA’s are provided

for under the Wildlife (Amendment) Act, 2000.

There are multiple Special Areas of Conservation (SAC) and Proposed Natural

Heritage Areas (pNHA) identified within 5km of the Pfizer Newbridge site. These

are illustrated in Figure 4.3 (with the Pfizer Newbridge site indicated as a ‘black

dot’) and listed below:

• Pollardstown Fen SAC and pNHA (000396) located approximately 4.2km

west of the site;

• Mouds Bog SAC and pNHA (000395) located approximately 5km north-west

of the site;

• Curragh (Kildare) pNHA (000392) located approximately 4.5km south-west

of the site; and

• Grand Canal pNHA (002104) located approximately 3.5km south-east of the

site.

• Liffey Bank Above Athgarvan pNHA (001396) located approximately 4.1km

south-east of the site.

Pollardstown Fen is also designated as a RAMSAR site and Nature Reserve.

None of the SACs or pNHAs listed above are directly connected to the Pfizer

Newbridge site. However, as described in detail in Section 4.3.4, the site

discharges storm water to the River Liffey via the municipal storm water network.

A continuous Total Organic Carbon (TOC) monitor is fitted at the point of

discharge from the site, and no storm water contamination issues have been

detected either through continuous TOC monitoring or daily visual inspections.

As such, the existing Pfizer Newbridge facility does not impact on either the River

Liffey or the Liffey Bank Above Athgarvan pNHA.

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Figure 4.3: Designated Sites in vicinity of the Pfizer Newbridge site (the Pfizer

facility is indicated with a ‘black dot’)

4.3.3 Land & Soils

4.3.3.1 Baseline Environment

The CORINE Land Cover (CLC) inventory is a Pan-European land use and

landcover mapping programme. It supplies spatial data on the state of the

European environmental landscape and how it is changing over time. CORINE

Land Cover mapping classifies land cover under various headings. The main land-

use of the Pfizer Newbridge site is that of ‘artificial surfaces’.

The Pfizer Newbridge site is generally flat, but slopes in a northeast-southwest

direction. The north-eastern boundary lies at an approximate elevation of 90.0 m

Above Ordnance Datum (AOD) and the south-western boundary lies at

approximately 84.5mAOD.

According to the Geological Survey of Ireland (GSI) Groundwater Webmap, the

bedrock geology underlying the Pfizer Newbridge site is Dinantian Pure Bedded

Limestone. The subsoils overlying the bedrock within the site consist primarily of

Made Ground (including roads – tarmacadam; hardstanding areas –

concrete/gravel surfaces; landscaped areas, lawns), with limestone sands and

gravels to the north and south, as outlined in Figure 4.4 with the Pfizer

Newbridge site indicated as a ‘black dot’.

There are no sites of geological significance located within or in the vicinity of the

Pfizer Newbridge site.

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Figure 4.4: Sub-soils in the vicinity of the existing Pfizer Newbridge site (the Pfizer

facility is indicated with a ‘black dot’)

The Geological Survey of Ireland (GSI) rates aquifers based on their

hydrogeological characteristics as well as on the value of the groundwater

resource. Ireland’s entire land surface is divided into aquifer categories.

According to the GSI Webmap, the bedrock aquifer beneath the Pfizer Newbridge

site is classified as a Regionally Important Aquifer – Karstified (Rkd). Rkd

aquifers are those in which flow is more diffuse, storage is higher, there are many

high yielding wells and development of bored wells is less difficult (County

Kildare Groundwater Protection Scheme, 2002). The groundwater vulnerability at

the Pfizer Newbridge site and surrounding area is classified as High.

According to a GSI well database search 2 no. private wells are located within 1

km of the Pfizer Newbridge facility. These wells are located approximately 900m

to the southwest (i.e. upgradient) of the facility and a further 3 no. wells are

located just over a kilometre to the southwest. The yield and class of these wells is

unknown.

The Curragh Camp Public Water Supply is the only public water supply located

within approximately 10 km of the Pfizer site in Newbridge.

According to the Groundwater Source Protection Zone Map of Co. Kildare, the

Pfizer site is not located within a source protection zone. The closest source

protection zone is located around 3 of the wells of the Curragh Camp Public

Water Supply at the Curragh camp, 5km to the southeast of the Pfizer Newbridge

site.

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One other well, which is part of the Curragh Camp Public Water Supply is located

approximately 2.5km west north west of the Pfizer Newbridge site, in the

townland of Cornelscourt. This well does not currently have a source protection

zone delineated.

4.3.3.2 On-Site Operations

The Pfizer Newbridge facility is not required, under the conditions of their

existing IE Licence, to carry out soil monitoring on site. Groundwater levels

within four monitoring wells (AGW1 – AGW4) have been recorded on a bi-

annual basis since 1997 to date, in compliance with the condition of the sites IE

Licence.

The Pfizer Newbridge Annual Environmental Reports (AERs) for 2010 to 2017

were reviewed. Based on the groundwater monitoring information contained

therein, slightly elevated levels of particular compounds have been detected in the

groundwater, underlying the Pfizer Newbridge facility. However, these elevations

do not indicate the existence of an on-site contamination source given the nature

of operations conducted at the site and the groundwater protection measures in

place.

The quality of the groundwater is considered to be of a good standard and with

interferences from natural geological conditions and off-site agricultural sources

reducing the quality slightly.

All bulk solvents used are stored in above ground tanks in the Solvent Tank Farm

which are located in bunds. These solvents are transferred to/from the process area

in high integrity steel pipework. Liquid process materials in smaller quantities are

stored in drums or intermediated bulk containers, which are stored in bunded

Chemstores in designated outdoor impermeable paved areas (pads) or in the

Solvent Storage Area located within Building 4. Spill kits, containing absorbent

materials, are stored strategically around the site and relevant staff (Emergency

Response Team) are trained in the appropriate emergency response actions to take

in the event of a spill or leak.

If a spill or leak were to occur that is not contained at source, it is collected in

either the process wastewater or the storm water drainage systems, depending on

the location of the spill or leak. It is anticipated that any spill or leak that could

occur cannot easily enter the ground or the groundwater across the site. If spilled

or leaked process materials enters the storm water drainage system they would be

detected by the continuous TOC monitoring system, and the penstock would

automatically close (on reaching an EPA approved TOC action level) thereby

preventing discharge of potentially contaminated surface water from the site. This

retained surface water would be further analysed to determine the nature and

extent of contamination and establish an appropriate means of disposal. If spilled

or leaked process materials enter the process wastewater drainage system, they

would drain to the main WWTP and would be fully treated on site.

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4.3.4 Water


Since 2000, Water Management in the EU has been directed by the Water

Framework Directive 2000/60/EC (WFD).

The WFD has been transposed into Irish legislation by the European Communities

(Water Policy) Regulations 2003 (SI No. 722 of 2003) and requires that all

member states implement the necessary measures to prevent deterioration of the

status of all waters - surface, ground, estuarine and coastal - and protect, enhance

and restore all waters with the aim of achieving good status by 2015.

As part of the implementation of the EU Water Framework Directive 2000/60/EC

(WFD), EU member states are required to produce a River Basin Management

Plan(s) for each of their River Base Management Districts.

The Government of Ireland has recently published the second-cycle River Basin

Management Plan for Ireland 2018 – 2021. The Plan sets out the actions that

Ireland will take to improve water quality and achieve ‘good’ ecological status in

water bodies (rivers, lakes, estuaries and coastal waters) by 2027. For this second

cycle, a single national River Basin District has been defined. This has been

broken down into 46 catchment management units and 583 sub-catchment

management units.

The Pfizer Newbridge site is located in Hydrometric area 09: Liffey and Dublin

Bay, as well as in the WFD classified Catchment of the same name. The site is

located in the WFD classified sub- catchment ‘Liffey_SC_030.’

The nearest surface water body to the Pfizer Newbridge site is the River Liffey

located approximately 1km west of the site. The River Liffey rises in the Wicklow

Mountains, about 32km southwest of Dublin, and flows in a generally

northwesterly direction from its source to the Lackan Reservoir. The river then

runs westward in the Kildare lowland and gradually turns northwestward to

Newbridge and northeast to Celbridge and Leixlip. It then flows eastward through

the city of Dublin, in which it is extensively canalized and bordered with quays. It

empties into Dublin Bay, an arm of the Irish Sea, after a course of 80 km.

As part of the implementation of the WFD, baseline risk assessments of the water

bodies within each River Basin District were completed by the EPA over the

period 2006 – 2015. These assessments were made using water pollution

indicators, point and diffuse pollution sources, water abstractions and detail on

commercial activities. The risk assessment assigned a water quality status to each

waterbody and indicated a risk status namely, whether the water body would meet

the criteria for “good status” or would be considered “at risk” of not meeting the

standards by 2015.

According to the EPA ENVision Webmapper, the water quality of the River

Liffey north west of the Pfizer Newbridge site (down gradient) is classified as

‘good status (Q4)’ and water quality south west of the site (up gradient) is also

classified as ‘good status (Q4)’.

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Furthermore, the River Liffey down gradient to the Pfizer Newbridge site is

classified as ‘not at risk’ and thereby meeting the standards by 2015.

Flooding

Under Section 28 of the Planning and Development Act 2000, as amended, the

DoEHLG published guidelines entitled “The Planning System and Flood Risk

Management Guidelines for Planning Authorities” (November 2009).

These guidelines require planning authorities to introduce flood risk assessment as

an integral and leading element of the plan making process.

The Draft Strategic Flood Risk Assessment (SFRA), carried out as part of the

Newbridge Local Area Plan 2013 – 2019, provides an assessment of flood risk in

the area to inform strategic land-use decisions.

The SFRA has recommended that development proposals for the areas identified

as being at risk of flooding be subject to a site-specific flood risk assessment.

These areas are outlined in green in Figure 4.5. The Pfizer Newbridge site is

indicated with a ‘black dot’, and as indicated in Figure 4.5, is outside the 100-

year flood zone.

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Figure 4.5: Flood Risk in Newbridge (Source: Draft Strategic Flood Risk Assessment (SFRA) of the Newbridge Local Area Plan 2013 – 2019) (the

Pfizer facility is indicated with a black dot)

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Trade& Foul Wastewater

The Pfizer facility at Newbridge has an on-site enclosed state of the art

wastewater pre-treatment plant (main WWTP for the treatment of API from the

process wastewater), commissioned in 2006 and is used to treat both trade

(process) and foul (domestic) effluent. Both networks serve the entire site through

a conveyance system draining to the main WWTP to the south-east of the site (an

OFG WWTP treats wastewater from the canteen and is subsequently discharged

to the main WWTP).

Wastewater from the trade sewer and foul effluent networks, enter the WWTP

through an influent wet well. Initial treatment is with a drum screen to remove

larger solids. Following screening, the wastewater enters one of two balance tanks

which are equipped with propellers and agitators.

Following physical treatment, the wastewater undergoes aerobic biological

treatment followed by effluent polishing using ozone oxidation. The intent behind

biological treatment is to reduce the wastewater bulk organic fraction and in doing

so, minimize the downstream ozone demand. MBR technology (biological

treatment coupled with ultrafiltration) is in place to yield a high-quality effluent

devoid of suspended solids and solids-associated APIs. Some removal of certain

APIs occurs in the biological system.

Ozone oxidation is used to remove APIs that passed through the biological

system.

The resultant treated wastewater stream (Emission Point Reference No. SE1) is

pumped to the tie-in with the Kildare County Council municipal sewer. Effluent

discharged through this route is monitored in accordance with Schedule C.3.2 of

IE Licence Register No. P0153-05.

Wastewater from Newbridge town, including treated wastewater from Pfizer

Newbridge, is ultimately treated at Osberstown Wastewater Treatment Plant,

where treated wastewater is subsequently discharged into the River Liffey.

The Pfizer Newbridge AERs for 2010 to 2017 have been reviewed and no

exceedances in the emission limit values (ELVs) for all wastewater parameters

have been recorded during each year of monitoring.

Storm Water Drainage

Surface water generated from a rainfall event is collected through systems of

storm water drains networked around the Pfizer site from building roofs, car

parks, roads and all hard-standing areas. The storm water systems are fitted with

oil interceptors and flow underground directly to the site surface water discharge

point (Emission Point Reference No. SW1), prior to discharge to the municipal

surface water drainage system which in turn discharges to the River Liffey.

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Also located on the site is a 1,400m3 surface water attenuation tank (to ensure that

potential surges of water to the on-site surface water drainage system and

subsequent surcharging of the municipal storm water sewer is prevented), which

is connected to the surface water network from specific areas of the site and

drained through SW1. There is a continuous TOC (Total Organic Carbon) monitor

located at the SW1 discharge point, with all other specified parameters monitored

periodically in line with the requirements of Schedule C.2.3 of Licence Register

No. P0153-05.

The surface water penstock will be activated if the TOC analyser detects dissolved

organic substances above warning and action set point values which have been

agreed with the EPA or if the sprinkler system is activated.

No issues have been detected either through visual controls or through continuous

TOC monitoring (the TOC action setpoints have not been exceeded due to a

contamination event since installation of the TOC analyser).

Monitoring results reviewed for 2010 to 2017 (as per Pfizer Newbridge AERs)

indicate that the surface water discharge from the Pfizer facility at Emission Point

Reference No. SW1, the surface water outfall point, is of good chemical quality,

and surface water discharging from the site is not resulting in impacts to the

receiving waters into which it ultimately discharges (i.e. River Liffey).

4.3.5 Noise and Vibration


The Environmental Noise Directive (END) (2002/49/EC) requires that action is

taken by each member state, with a view to preventing and reducing

environmental noise where necessary (particularly where exposure levels can

induce harmful effects on human health) and to preserving environmental acoustic

quality where it is good. The relevant local authorities have been designated by

the Environmental Noise Regulations, S.I. Regulations No. 140 of 2006, as the

bodies charged with development and making of ‘Noise Action Plans’.

Kildare County Council prepared the second Noise Action Plan for County

Kildare in 2013. This Noise Action Plan primarily considers the long term

environmental noise impact from road, rail and air traffic noise sources, and sets

out an approach to review noise impact levels near to the major sources assessed

during the strategic noise mapping in 2012 with a view to identifying locations

where noise reduction is deemed necessary in the first instance. In County Kildare

there are no major agglomerations or major airports subject to noise mapping or

action planning.

Strategic Noise Maps have been prepared for all roads deemed to fall within the

threshold of 3 million vehicles a year. The total length of identified major roads

included within the strategic noise mapping was 258 km which amounts to 10.2%

of the total road network which is relatively large compared to other counties.

This broke down into 157 km of motorways and national roads, 94.4 km of

regional roads and 6.4 km of local road.

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The Pfizer Newbridge facility is located on the R445 regional road. The Noise

Action Plan identifies the R445 as a major road which qualifies for noise

mapping.

The Strategic Noise Map showing the section of the R445 in proximity to the

Pfizer Newbridge site is illustrated in Figure 4.6 for the Day time levels and

Figure 4.7 for the Night time levels (Pfizer Newbridge site is indicated with a

‘black dot’ in each figure).

Noise levels emanating from the section of the R445 road located along the Pfizer

Newbridge facility and subsequently experienced at the site, range from 55-64dB

during the day (refer to Figure 4.6) and 50-54dB at night (refer to Figure 4.7).

Figure 4.6: Strategic Noise Mapping of R445: Day (the Pfizer facility is indicated

with a black dot)

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Figure 4.7: Strategic Noise Mapping of R445: Night (the Pfizer facility is indicated

with a black dot)

The plan concludes that that there are an estimated 969 people in County Kildare

experiencing noise levels above the Lden threshold for noise from road traffic

sources, and an estimated 5564 people experiencing noise levels above the Lnight

threshold (which consists of 3,674 people experiencing noise levels from road

traffic sources and 1,890 people experiencing noise levels from rail traffic

sources).

The plan notes that a programme for further assessment and the implementation of

potential noise mitigation measures in areas above the threshold of assessment

will be required. The general approach to be taken by Kildare County Council in

managing the environmental noise in the area will involve:

• Noise reduction at source;

• Land use planning adapted to noise goals;

• Procedures to reduce noise impact; and

• Operating restrictions to reduce noise emissions.

Kildare County Council has developed a detailed Programme of Works for the

duration of the Noise Action Plan (2013 to 2018) and proposed to implement the

programme subject to the availability of the requisite technical staff, expertise and

financial resources.

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In accordance with their existing IE Licence, the Pfizer Newbridge facility is

required to comply with the noise limits outlined in Table 4.2 for day and night

time operations at nearby noise sensitive locations.

Table 4.2: Operational Noise Limits for the Pfizer Newbridge facility

Daytime dB(A) LAeq (30 minutes) Night-time dB(A) LAeq (30 minutes)

55 45

Pfizer Newbridge carries out an environmental noise survey of the site annually,

in compliance with Condition 6.13 of their IE Licence.


exceedances in the emission limit values (ELVs) for noise have been recorded

during each year of monitoring.

4.3.6 Air Quality and Climate


Air Quality

The EPA measures the levels of a number of atmospheric pollutants throughout

Ireland in order to measure compliance with Air Quality Standards Regulations,

2011 (S.I. No. 180 of 2011). For the purposes of monitoring in Ireland, four zones

are defined in the Regulations:

• Zone A: Dublin Conurbation;

• Zone B: Cork Conurbation;

• Zone C: Other Cities and Large Towns; and

• Zone D: Rural Ireland which is the remainder of the State excluding Zones A,

B and C.

Newbridge is located in Zone C. The Air quality in Zone C as reported in the EPA

report ‘Air Quality in Ireland 2016” is summarised in Table 4.3 below.

Table 4.3: Air Quality Assessment Zone C Concentrations compared to Air Quality

Standards

Parameter Zone Average measured

concentration (µg/m3)

Air quality standard

(µg/m3)

NO2 Zone C 9.25 40

SO2 Zone C 16.5 20

CO Zone C 2 10

PM10 Zone C 15 40

PM2.5 Zone C 10 20

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The EPA manages the National Ambient Air Quality Network. This Network sets

legislative limit and target values for protection of human health and vegetation.

According to the ‘Air Quality in Ireland Report 2016’ no levels above the EU

limit values were recorded in Ireland in 2016.

The EPA 2016 dioxin survey shows that concentrations of dioxins and similar

pollutants remain at a consistently low level in the Irish environment.

Current and future challenges to air quality in Ireland were identified as follows:

• Reduction of solid fuel use;

• Efficient traffic management and provision of choice in terms of public

transport in towns; and,

• Transboundary impacts of ozone, to which Ireland’s air mass is subject.

Climate

The existing climate at the Pfizer Newbridge site corresponds with the general

climatic conditions for Ireland which is dominated by the Atlantic Ocean and its

air and oceanic currents. Consequently, the Kildare region does not suffer from

extremes of temperature. According to Met Éireann, average annual temperature

is about 9°C. Mean annual wind speed varies between about 4 m/sec in the east

midlands and 7 m/sec in the northwest.

Average rainfall in the Kildare region varies between about 800 and 2,800 mm.

Rainfall accumulation tends to be highest in winter and lowest in early summer.

According to the United Nations Integrated Panel on Climate Change, in line with

the global picture, Ireland's average temperature has increased by about 0.7°C

over the last 100 years, and the rate of increase has been higher in the last couple

of decades. The increase has not been uniform over time, with a warming period

from 1910 to the 1940s, followed by a cooling period up to the 1960s. The current

warming period commenced around 1980.

At the time of writing of this report, 2006 was the warmest year recorded in

Ireland since the record-breaking year of 1995 at both Malin Head and Phoenix

Park, which have observations dating back over 100 years, and also at Casement

Aerodrome, Kilkenny and Rosslare.

At the time of writing of this report, 2016 has been recorded as the warmest year

since 2006, and the last 10 years have been the warmest decade. Whilst we can be

less categorical about wind speeds, there is some evidence of a reduction in

annual average wind speeds, with a corresponding decrease in the frequency of

high wind speeds and gusts. Increases in total annual rainfall in parts of the west

and north of Ireland have been observed, with some increase in the number of

days with heavier rain but there is no clear pattern of change in other areas.

While the national scale of potential change is evident, translating the potential

effects of climate change to a region is a process of inference on what will happen

to Ireland at large being reduced to a regional scale. Temperatures in Ireland are

predicted to increase by 1.25 – 1.5°C by 2040 compared to 1961 to 2000.

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Rainfall is expected to increase in Ireland in winter by about 15% and summer

projections range from no change to a 20% decrease, potentially along the east

coast of the country.

Studies have shown that extreme rainfall events associated with climate change

show more marked changes with more events occurring in autumn and a 20%

increase in 2-day extreme rain amounts, especially in northern areas. Taking the

projected precipitation changes into account, there will be the potential for a

significant increase in the number of extreme discharge events and a slight

increase in their intensity, leading to an increased probability of flooding in the

future.

The potential rise in global temperature might affect the intensity and frequency

of storms in the North Atlantic. As a consequence of stormy weather there exists

the potential for flash flooding and erosion which would affect a wide range of

ecosystems and economic sectors.

Climate Change Targets

In December 2008, the EU Climate Change and Renewable Energy Package set

out a number of commitments. This package commits to reduce the EU’s

Greenhouse Gas (GHG) emissions from non-Emission Trading Scheme (ETS)

sectors (such as transport, agriculture, residential and waste) by 20% on 2005

levels by 2020 or by a more ambitious 30% in the event of a comprehensive

global agreement.

As part of the effort-sharing proposal of this package, Ireland is one of the

countries facing the highest target of a 20% reduction on 2005 levels for non-ETS

sectors.

This will result in a limit of approximately 38 million tonnes CO2 equivalent for

Ireland’s non-ETS emissions in 2020, together with annual binding limits for each

year from 2013 to 2020.

In October 2014, EU leaders agreed a 2030 policy framework to reduce

greenhouse gas emissions by at least 40% compared to a 1990 baseline. No

agreement on the contribution of individual EU Member states has yet been

reached.

The Climate Action and Low Carbon Development Act was published by

government in January 2015. The Act sets out the national objective of

transitioning to a low carbon, climate resilient and environmentally sustainable

economy in the period up to 2050.

The EPA produces greenhouse gas emission projections on an annual basis for all

sectors of the economy. According to the latest set of projections (April 2017),

based on two different scenarios, Ireland’s emissions in 2020 could be in the

range of 4-6% below 2005 levels. The projection figures indicate Ireland is likely

to exceed its annual targets over the remainder of the period to 2020.

It is noted that while energy consumption reduction and water conservation

programmes are adopted at the site, additional on-site developments will result in

increased energy and water usage at the site.

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Notwithstanding, the proposed developments are designed to include energy

reduction and water conservation aspects.

Pfizer Newbridge has been granted a Greenhouse Gas Emission Permit (Permit

Register No. IE-GHG057-10372-3) by the EPA. This permit authorises Pfizer

Newbridge to undertake energy consumption activities associated with onsite

boilers and the combined heat and power (CHP) plant (combustion installation)

which result in emissions of the greenhouse gas, carbon dioxide. Participation in

the continued development of appropriate climate change and greenhouse gas

policies of the EU Emissions Trading Schemes facilitates Pfizer Newbridge to

reduce energy consumption and associated greenhouse gas emissions at the site.

The publication Ireland’s Environment 2016 – An Assessment (EPA, 2016)

provides a high-level summary on the status of greenhouse gases and climate

change in an Irish context. It describes the key drivers and pressures and

responses to climate change that may occur, providing an outlook of greenhouse

gas projections to 2020, and also identifies future challenges to be addressed.


The existing Pfizer Newbridge facility currently has over 100 licenced

atmospheric emission points. These emission points include particulate dust

emission points, Volatile Organic Compound (VOC) emission points, and boiler

emission points (gas combustion). There are also many minor emission points on

the Pfizer Newbridge site, mainly relating to laboratory operations and HVAC

emissions (clean building air).

The primary contaminants of air streams at the facility comprise of dust

particulates and VOCs. Particulates may contain Active Pharmaceutical

Ingredients (APIs). Particulate emissions occur mainly as a result of tablet

manufacture and to a lesser extent from the tablet packaging process. Emissions

are minimised through employing a combination of abatement (e.g. HEPA

filtration) and control (e.g. continuous differential pressure monitoring across

HEPA filters to ensure they are operating correctly) measures.

Under the provisions of their existing IE Licence, the Pfizer Newbridge facility is

required to carry out monitoring of emissions to atmosphere.


exceedances in the emission limit values (ELVs) for any of the atmospheric

emission points have been recorded during this period.

4.3.7 Traffic and Transportation


The Pfizer Newbridge facility is located approximately 1km to the North East of

Newbridge town centre on the R445. The entrance to the existing facility is

located 85m southeast of Buckley’s crossroads along the Greatconnell Road.

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The R445, formerly the N7, formed the national primary route from Dublin to

Limerick until the opening of the M7 motorway bypass of Newbridge. This road

has since been downgraded to a regional road. The R445 now forms the most

direct road from Newbridge to Naas and provides access to the M7 motorway.


The Pfizer Newbridge site operates 24 hours per day, 5 days per week, with up to

750 employees on site. There are currently limited production activities over the

weekend period.

The site currently generates approximately 40 HGV (Heavy Goods Vehicle)

movements per day, 5 days per week. The Pfizer Newbridge facility is currently

accessed via an entrance located on the western boundary of the site, and a

signalised junction at the north-eastern corner of the site.

The Transport Infrastructure Ireland (TII) Traffic Data website was also reviewed

in order to assess the relevant data collected from the TII traffic counters on the

National Road Network. The TII traffic counter of closest proximity to the Pfizer

Newbridge facility is located on the M7, between Junction 12 at Newbridge and

the Junction of the M7/M9 at Greatconnell, Co. Kildare. Table 4.4 outlines the

annual traffic count data at this location.

Table 4.4: M7 Traffic Count Data in proximity to the Pfizer Newbridge Site

2018 2017 2016

Annual Average

Daily Traffic 44,353 45,116 37,285

% Heavy Goods

Vehicles 7.5% 7.3% 7.1%

Coverage 72.9% 99.7% 99.7%

4.3.8 Material Assets

4.3.8.1 Land-Use

As described in Section 5, the proposed development site is entirely within the

existing envelope of the Pfizer Newbridge facility, which is owned by Pfizer

Ireland Pharmaceuticals.

4.3.8.2 Services and Utilities

There is a 110kV sub station (Building 12) located to the south east of the site

adjacent to the main WWTP. There is also a Combined Heat and Power (CHP)

plant on the site to supplement the energy provided by the boilers. The CHP plant

provides power and hot water to the site in addition to the national grid. The CHP

plant is fuelled by natural gas. The boilers are also fuelled by natural gas with

diesel only used if there is a shortage in the natural gas supply (which has not

occurred to date at the time of writing this report).

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In addition to these systems, there are emergency generators for short-term power

supply to individual building areas located on the site (selected generators or fire

pumps have localised storage of diesel in bunded areas). Diesel refuelling is

carried out using a bowser to refuel these tanks.

The site is currently served by a Bord Gais low pressure gas main.

4.3.8.3 Water Supply

Currently Newbridge town is connected to the Ballymore Eustace Reservoir, as

part of the Mid-Regional Water Supply Scheme. Water supply is adequate to

serve the present needs of the town and will be enhanced in the long term with the

completion of the River Barrow Abstraction Scheme. Kildare County Council

constructed a distribution main in the Great Connell and Little Connell areas in

recent years and this has improved the distribution network within the town.

The Pfizer Newbridge site is currently served with potable water by a connection

to the existing Newbridge town supply (Kildare County Council water main) and

currently receives some 500 m3/d of potable water from this supply.

4.3.8.4 Drainage

Refer to Section 4.3.4.3 of this Screening Report for a description of the existing

drainage network at the Pfizer Newbridge site.

4.3.8.5 Wastewater Treatment

Refer to Section 4.3.4.2 of this Screening Report for a description of the existing

wastewater treatment at the Pfizer Newbridge site.

As previously outlined, a Wastewater Pre-Treatment Plant (main WWTP) is

located on the existing Pfizer Newbridge site, and resultant treated wastewater

stream the (Emission Point Reference No. SE1) is pumped to the tie-in with

Kildare County Council municipal sewer where it is ultimately treated at

Osberstown Wastewater Treatment Plant.

In 2015, Irish Water identified that the previously existing infrastructure of

Osberstown wastewater treatment plant was under pressure and unable to support

future economic and social development in the region. Irish water subsequently

announced a major upgrade of the wastewater treatment plant. This €30.3 million

upgrade represented the largest single investment to date in the upgrade of a

wastewater treatment plant by Irish Water.

Construction of the plant has recently been completed, and process proving has

commenced. The plant now has a final treatment capacity of 130,000 Population

Equivalent (PE) and a higher level of treatment in full compliance with EPA

environmental licenses. The newly upgraded plant serves the many industries,

local businesses and homes in Newbridge including the treated wastewater from

the Pfizer Newbridge site.

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The Osberstown wastewater treatment plant discharges treated wastewater into the

River Liffey making it one of the largest inshore discharge points in the country.

4.3.9 Waste Management

The Pfizer Newbridge facility routinely generates production related hazardous

and non-hazardous waste i.e. wastes generated during the production process.

Hazardous wastes include solid and liquid pharmaceutical waste, non-chlorinated

solvents and chlorinated solvents. Non-hazardous wastes include general domestic

waste, cardboard/paper, glass and plastic from both day-to-day operational and

construction/project activities.

The site records details of all wastes produced at the site and maintain records of

all waste movements from the site, including waste contractors used and final

recycling/recovery/disposal (incineration, landfill) means.

The Pfizer Newbridge AER for the year 2017 was reviewed to inform this

baseline assessment. Table 4.5 outlines the quantity of waste generated on site in

2017.

Table 4.5: 2017 Waste Quantities

Total

(Tonnes)

Landfill

(Tonnes)

Incineration(Tonnes) Recycled

(Tonnes)

Hazardous 720 - 330 390

Non-Hazardous 940 2 55 883

4.3.10 Archaeology, Architectural and Cultural Heritage

4.3.10.1 Archaeological Heritage

A record of archaeological heritage is maintained on the ‘Record of Monuments

and Places’ which was established under Section 12 of the National Monuments

(Amendment) Act, 1994 (No. 17 of 1994). Structures, features, objects or sites

listed in this Record are known as Recorded Monuments.

The Record of Monuments and Places (RMP) comprises a list of recorded

monuments and places and accompanying maps on which such monuments and

places are shown for each county.

The National Monuments Service of the Department of Arts, Heritage, Regional,

Rural and Gaeltacht Affairs will advise on the protection applying to any

particular monument or place under the National Monuments Acts by reason of it

being entered in the Record of Monuments and Places and should be consulted if

there is any doubt as to the status of the site.

The archaeological heritage of Newbridge includes structures, constructions,

groups of buildings, developed sites, recorded monuments as well as their

contexts, and moveable objects, situated on land. Archaeological heritage is not

confined to the archaeological sites within the Record of Monuments and Places.

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It includes any archaeological site that may not have been as yet recorded, as well

as archaeology beneath the ground surface, and the context of any site.

According to the database, one Recorded Monuments was noted within the Pfizer

Newbridge site-KD023-110, which is classified as a ‘burial.’

In 2004, portion of a pottery vessel containing fragments of cremated bone was

found during a programme of unlicensed monitoring of topsoil-stripping at the

Pfizer facility. The feature was archaeologically excavated under licence (Licence

no. 04E1555 www.excavations.ie) with the assistance of a conservator and

appears to represent the remains of a Bronze Age cremation burial that was

contained within a small upright pottery vessel.

The vessel was initially removed from the site in a stabilised earthen block and

later excavated in controlled laboratory conditions.

Figure 4.8 illustrates existing features of archaeological, architectural and cultural

heritage (indicated as ‘red dots’) in proximity to the Pfizer Newbridge site (the

Pfizer facility is indicated with a ‘black dot’).

4.3.10.2 Architectural and Cultural Heritage

As defined by the Heritage Act, 1995, 'architectural heritage' includes all

structures, buildings, traditional and designed, and groups of buildings including

streetscapes and urban vistas, which are of historical, archaeological, artistic,

engineering, scientific, social or technical interest.

The National Inventory of Architectural Heritage (NIAH) is a state initiative

under the administration of the Department of Arts, Heritage, Regional, Rural and

Gaeltacht Affairs and established on a statutory basis under the provisions of the

Architectural Heritage (National Inventory) and Historic Monuments

(Miscellaneous Provisions) Act 1999.

The purpose of the NIAH is to identify, record, and evaluate the post-1700

architectural heritage of Ireland, uniformly and consistently as an aid in the

protection and conservation of the built heritage. NIAH surveys provide the basis

for the recommendations of the Minister for Arts, Heritage, Regional, Rural and

Gaeltacht Affairs to the planning authorities for the inclusion of particular

structures in their Record of Protected Structures (RPS).

While a number of Protected Structure are located in Newbridge Town, according

to the database, there are no Protected Structures at, or in close proximity to the


Figure 4.8 illustrates existing features of archaeological, architectural and cultural

heritage (indicated as ‘blue dots’) in proximity to the Pfizer Newbridge site (the

Pfizer facility is indicated with a ‘black dot’).

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Figure 4.8: Features of Archaeological and Architectural significance in proximity

to the Pfizer Newbridge site (the Pfizer facility is indicated with a black dot)

4.3.11 Landscape and Visual

4.3.11.1 Landscape

The location and context of the existing Pfizer Newbridge site is outlined in

Section 3.3.

A Landscape Character Assessment (LCA) of the county has recently been

prepared as part of the Kildare County Development Plan. 2017-2023. The LCA

focused on characterisation i.e. the discernment of the character of the landscape

based on its land cover and landform, but also on its values, such as historical,

cultural, religious and other understandings of the landscape.

The County is divided into 15 geographically specific Landscape Character Areas

(LCA’s) The Pfizer Newbridge site is located in the Northern Lowlands LCA.

In order to inform the Landscape Character Assessment, a landscape sensitivity

map was prepared. Landscape sensitivity is a measure of the ability of the

landscape to accommodate change or intervention without suffering unacceptable

effects to its character and values.

The sensitivity of the Northern Lowlands is deemed to be of ‘Low-Sensitivity’

and is defined as an area ‘with the capacity to generally accommodate a wide

range of uses without significant adverse effects on the appearance or character

of the area.’

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As outlined in Section 4.3.3, and as defined by The CORINE Land Cover (CLC)

inventory, the main land-use of the Pfizer Newbridge site is that of ‘artificial

surfaces’.

4.3.11.2 Visual

The Pfizer Newbridge facility is a significant landmark upon entry to Newbridge

town along the R445 located to the east of the facility. The character of the Pfizer

Newbridge site is that of a large-scale industrial development with well-

maintained landscaped grounds and mature boundary vegetation located at the

fringes of an expanding urban centre.

Lands to the east of the Pfizer Newbridge site comprise open farmland (where

expansion of the supermarket distribution centre is currently taking place) with

scattered residential dwellings and farm buildings; to the west are mainly

residential properties.

Views from Major Roads

Travelling southwest along the R445 towards Newbridge town, there are partial

views of the upper portions of the existing Pfizer facility through boundary

hedgerows and mature trees. The visibility of these existing buildings increases on

the approach to the Buckley’s Cross roundabout near the current Pfizer

Newbridge site entrance. These are significant views as the development falls

within the line of sight for approximately 1.5km on this north-eastern approach to

the Pfizer site.

Views from Other Roads and Transport Routes

The second road vista is from Greatconnell Road at the Pfizer Newbridge site

western/southern boundary, which also serves as an access road for the facility.

From this road south of the site entrance, roadside planting and landscaped

mounds filter views into the site.

Only taller structures within the existing facility are evident as the viewer moves

further south towards Baroda Court residential estate and Great Connell. Beyond

this point, roadside vegetation completely screens views of the Pfizer site.

There are open views towards the Pfizer site from the road leading from

Greatconnell Road to the Lidl Distribution depot. Other significant views of the

Pfizer site from local roads include that from Sex’s Road, running adjacent in the

vicinity of the River Liffey at this point. These views are potentially significant

due to the proximity to Newbridge town centre and the River Liffey itself, but

existing mature trees located along the riverside and on intervening lands limit

these views.

Views from Public Buildings, Open Space & Residential Areas

There are no public buildings in the vicinity of the Pfizer Newbridge site.

Designated Open Space lies adjacent to the River Liffey within the grounds of

Newbridge College, west of the Pfizer site. There are partial views of the Pfizer

site from here, where taller buildings appear through existing vegetation.

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Residential areas with views of the Pfizer site mostly lie in close proximity to the

site. Several residences located along Greatconnell Road have partial views that

are obscured at intervals by Pfizer boundary vegetation.

There are a number of residences located relatively close to the Buckley’s Cross

roundabout where views into the Pfizer site are partially obscured by intervening

vegetation located between these properties and the road. The housing estate

located further south along Greatconnell Road at Baroda Close has less scope for

views of the Pfizer site due to existing vegetation although the taller structures of

the existing Pfizer site are visible from this location.

There are residences north of the site that have potentially significant views of the

Pfizer site, although these are partially obscured by existing vegetation. The first

of these is Oldconnell House, which lies some 350m northwest of the Pfizer site

and is partially screened by intervening vegetation. A single house occurs north of

the site adjacent to the R445, while there is also a farmhouse located to the

northeast of the site; both have filtered views through intervening trees into the

Pfizer.

There are views of the taller existing buildings within the Pfizer facility from

residences at the Grange housing estate along Sex’s Road, adjacent to the River

Liffey to the west. However, these views are partially obscured by mature

vegetation in the grounds of Newbridge College. The grounds of Newbridge

College are afforded similar views to the taller existing structures on the Pfizer

site.

Views from Sites of Historical Importance. Archaeological Sites and

Designated Viewpoints

There are no protected structures within the vicinity of the Pfizer Newbridge site

that will be affected, and the site does not fall within an Area of Archaeological

Interest.

The available viewpoints along the River Liffey are largely confined to points

located along Sex’s Road where breaks in the vegetation afford views to the taller

existing structures on the Pfizer site. Elsewhere views are obscured by intervening

vegetation, such as that within the grounds of Oldconnell House, or by the

existing town.

4.3.12 Risk of Major Accidents and/or Disasters

4.3.12.1 Natural Disasters

Ireland’s geographic position means it is less vulnerable to natural disasters such

as earthquakes or tsunamis, which might pose risk to projects of this nature and

scale in other locations. However, in recent times there has been an increase in the

number of severe weather events in the country, particularly those leading to

flooding and flash flood incidents.

As outlined in Section 4.3.4.1, Pfizer Newbridge site is outside the 100-year flood

zone of the River Liffey and is therefore not ask risk from flooding.

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4.3.12.2 Major Accidents

An Environmental Liabilities Risk Assessment (ELRA) was carried out for the

existing Pfizer Newbridge facility in 2015. According to the ELRA, the

reasonable and plausible worst-case scenario risk of a major accident occurring on

site was identified is a fire starting in Production Building 3A.

This scenario, taken from the URS 2011 Firewater Retention Study, involves a

fire starting within one of the Glatt® fluidised bed dryer units located in Building

3A, which spreads throughout the 3A production building where processes

involve the handling of APIs and organic solvents.

Although the sprinklers are activated, it is assumed that the fire will still spread

and will require firefighting from 4 fire tenders linked to the site hydrant system.

The resultant fire is assumed to be contained within the 3A production building

and lasts for two hours.

The worst-case scenario risk identified would result in injury or loss of life to

employees of the Pfizer Newbridge facility.

Two industries in County Kildare are affected by the Seveso II Directive under

the European Communities (Control of Major Accident Hazards Involving

Dangerous Substances) Regulations, 2006 S.I. No. 74 of 2006. This Directive is

concerned with the prevention of major accidents that involve dangerous

substances and the limitation of their consequences for humans and the

environment. Those industries affected are;

• Irish Industrial Explosives Clonagh, Enfield (Upper Tier Site) (approximately

20km from the Pfizer Newbridge site);

• Intel Ireland Ltd Collinstown Industrial Park, Leixlip (Lower Tier Site)

(approximately 20km from the Pfizer Newbridge site).

There is an Internal Emergency Plan for both establishments but there is also an

External Emergency Plan in place for Irish Industrial Explosives, as it is an Upper

Tier Site. The common objectives of internal and external emergency plans are as

follows:

• Containing and controlling incidents so as to minimise the effects and to limit

damage to people, the environment and property;

• Implementing measures necessary to protect people and the environment from

the effects of major accidents;

• Communicating necessary information to the public and to the services or

authorities concerned in the area;

• Providing for the clean-up and restoration of the environment following a

major accident.

The existing Pfizer Newbridge facility is not classified as either a lower or upper

tier facility under the European Communities (Control of Major Accident Hazards

Involving Dangerous Substances) Regulations.

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5 Characteristics of the Proposed

Development

5.1 Introduction

This section describes the physical characteristics of the proposed development

with particular regard to design, construction and operational elements of

relevance to this EIA Screening Report.

5.2 Overview

As outlined in Section 1, the proposed development is required to facilitate the

introduction of new production processes for the manufacture of GITS products,

and to provide additional capacity at the existing TIC.

The proposed development will involve the retrofitting of existing buildings,

including the installation of new processing equipment (as well as the introduction

of additional new particulate and solvent emission points), installation of a

number of additional penthouse louvres at roof level for the Air Handling Unit

(AHU) intake and exhaust, modification to the existing solvent tank farm, the

provision of two new tanks adjacent to Building 7, the installation of two end-of-

line VOC abatement units (thermal oxidation) and one non-thermal end-of-line

VOC abatement unit, for the treatment of solvent vapour emissions, and the

installation of a new steam boiler.

Figure 5.1 illustrates the location of the proposed development, at the existing

Pfizer Newbridge facility.

Figure 5.1: Overview of the Pfizer Newbridge Site with outline location of proposed

development indicated

Further detail on the proposed development is provided in Section 5.3 and Section

5.4.

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5.3 Construction Phase

The construction phase of the proposed development would primarily relate to the

retrofitting of existing buildings, including the installation of new processing

equipment, installation of a number of additional penthouse louvres at roof level

for the Air Handling Unit (AHU) intake and exhaust, modification to the existing

solvent tank farm, the provision of two new tanks adjacent to Building 7 and the

installation of two end-of-line VOC abatement units (thermal oxidation) and one

non-thermal end-of-line VOC abatement unit, for the treatment of solvent vapour

emissions. The proposed development will involve the introduction of additional

main emission points (3 No. solvent; ~10 No. dust; 1 No. boiler).

It is anticipated that the construction phase of the proposed development will

occur over a period of approximately 9 months.

All construction works will be carried out during day time hours.

These works are described in more detail in Section 5.3.1 – Section 5.3.4.

5.3.1 Building 3 (Extended Technology Innovation Centre)

The construction phase of the proposed development will involve the retrofitting

of a previously used manufacturing area in Building 3 (one floor) and the

installation of new manufacturing equipment to provide additional capacity for the

site.

The VOC emissions emanating from the extended TIC coating process in

Building 3 will exhaust to an end-of-line non-thermal solvent abatement unit,

which is likely to be located externally to Building 3.

The non-thermal end-of-line VOC abatement unit will utilise an existing vent

stack located on the roof of Building 3.

The proposed installation of the external end-of-line VOC abatement unit will

require some minor groundworks in order to connect the installations to existing

site services and utilities. However, the depth of excavations required to facilitate

these works is expected to be minor and all works will take place on the existing


5.3.2 Building 3C-2

The construction phase of the proposed development will involve the retrofitting

of Building 3C-2 to provide for the installation of new upstream GITS process

equipment, including new drying ovens in Building 3C-2, for solvent granulation

and coating, and solvent solution preparation.

The works involved in the installation of this equipment will be internal (Building

3C-2) and will occur over the 3 existing floors of Building 3C-2. The proposed

new process equipment will require the introduction of a number of new dust

emission points on the roof of Building 3C-2 measuring 21m (above ground

level).

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5.3.3 Building 8

The construction phase of the proposed development will involve the

removal/decommissioning of building internals from Building 8, including the

steam boiler system, chilled water system, cooling tower system, water pipes,

compressed air plan and equipment, electrical equipment and other mechanical

plant and equipment. It will also involve the installation of two end-of-line VOC

abatement units for the treatment of VOC’s from the GITS processes (one end-of-

line unit for Non-Chlorinated VOCs and one end-of-line unit for Chlorinated

VOCs). The end-of-line VOC abatement units will utilise the existing main vent

stack at Building 8 (currently used for boiler emissions).

5.3.4 Tanks

The proposed development relates to a minor extension to the south of the

existing solvent tank farm. Two of the existing solvent storage tanks will also be

repurposed to facilitate the storage of Acetone and Methanol (which will be

required to support the GITS manufacturing process). A new acetone waste tank

will be located at the existing solvent tank farm.

One new bulk chlorinated waste storage tank (for waste from the Reverse

Osmosis scrubbing process for the end-of-line VOC abatement units) and one new

caustic tank will be installed adjacent to Building 7.

These tanks will include for a tight design with double-walls, nitrogen blanket,

vapour balanced for loading/unloading operations to minimise fugitive emissions.

It is proposed that four centrifugal pumps will be installed in the solvent tank

farm.

The proposed installation of the bulk storage tanks will require some minor

groundworks in order to connect the installations to existing site utilities.

However, the depth of excavations required to facilitate these works is predicted

to be minor and all works will take place on the existing Pfizer Newbridge site.

5.3.5 Steam Boiler

The proposed development relates to the installation of a steam boiler in the existing

Central Utilities Building (Building 5) to support the GITS manufacturing process.

The boiler will normally run on natural gas. In the event of interruption of the gas

supply to the site a back-up diesel oil (<0.2% sulphur) supply will be used.

The proposed installation of the steam boiler will require some minor

groundworks in order to connect the installations to existing site utilities.

However, the depth of excavations required to facilitate these works is predicted

to be minor and all works will take place on the existing Pfizer Newbridge site.

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5.4 Operational Phase

The proposed development involves the introduction of new production processes

at the existing Pfizer Newbridge facility for the manufacture of GITS products.

The new products will be used for the manufacture of hypertension, anxiety, type

II diabetes, high blood pressure and arthritis.

5 No. Active Pharmaceutical Ingredients (APIs) will be used in the manufacture

of the GITS products. These are outlined in Table 5.1.

Table 5.1: GITS Products, Product Indication and API associated with each

product

Product Product Indication API

Cardura XL Treatment of hypertension & benign prostate hyperplasia Doxazosin

Mesylate

Glucotrol XL Treatment of Type II diabetes Glipizide

Minipress

XL

Treatment of hypertension & anxiety Prazosin

Hydrochloride

Procardia XL Treatment of high blood pressure Nifedipine

Xeljanz Treatment of Treatment of Rheumatoid, Psoriatic

Arthritis & Ulcerative colitis

Tofacitinib Citrate

It is anticipated that, once fully operational, the proposed development would give

rise to the production of approximately 720 million tablets/capsules when

operating under full capacity. This relates to an increase in production of

approximately 9%.

Figure 5.2 outlines an example product flow of the proposed new GITS

production processes.

Figure 5.2: Example Product Flow of Proposed New GITS Production Processes

The new GITS production processes will be similar to those already carried out on

site, but would consist of two new end-of-line VOC abatement technologies

(Thermal Oxidation) for the treatment of solvent vapour emissions (i.e. DCM,

Acetone, Ethanol and Methanol).

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https://urldefense.proofpoint.com/v2/url?u=http-3A__www.webmd.com_drugs_mono-2D9061-2DGLIPIZIDE-2BTABLET-2B-2D-2BORAL.aspx-3Fdrugid-3D10094-26drugname-3DGlipizide-2BOral&d=DwMCaQ&c=UE1eNsedaKncO0Yl_u8bfw&r=Bnti25pp9wJaVpbqJbjcP7KXtkdiOffuc_u7N3ZyOhU&m=rVGxiRT90kOVIzWjrAkuyf3fdZxy00SynK39_stGC_s&s=4p0kecOrmqMasVYFvwSbWCuyD4dXzAh910-5GONClVY&e=





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As outlined in Section 5.3.3, it is therefore proposed to install two end-of-line

VOC abatement units (Thermal Oxidation) in Building 8 (which will be designed

in accordance with Best Available Technology (BAT) principles to abate potential

solvent emissions. These emissions will be abated to ensure compliance with

Emission Limit Values (ELVs) specified in the revised the Industrial Emissions

(IE) licence and/or limits set out in the IE Directive.

The end-of-line VOC abatement units consist of a number of beds filled with

ceramic packing which are used in sequence with the bed that just come off line

being used to pre-heat the incoming gases.

The end-of-line VOC abatement units will work by breaking down the organic

compounds used in production processes, within a carefully controlled system in

the presence of heat and air, into combustion products including carbon dioxide

and water. Oxides of nitrogen and carbon monoxide can be produced from the

combustion process. Treated emissions will then be discharged to the existing

28m stack (previously used to house stack from boilers which have since been

decommissioned).

When the DCM is thermally oxidised, Hydrochloric Acid (HCL) and Chlorine

(CL) are formed in the internal airstream as part of the process. In order to remove

HCL and CL from the internal airstream, the end-of line VOC abatement units

will require the use of a water-based solution, containing caustic and sodium

bisulfite,

This removal process (scrubbing) will result in the formation of a waste stream

consisting of a salt solution with some excess caustic and sodium bisulphite, or

some excess HCl, depending on the pH point at which the scrubber blowdown is

discharged.

It is proposed that the scrubbing waste stream will be concentrated to remove a

significant proportion of the water, which will be discharged to the existing on-

site main WWTP for treatment, prior to discharge to the municipal sewer. The

concentrated waste will then be transferred to a bulk storage tank adjacent to

Building 7 for storage and subsequent removal from site for disposal.

The end-of-line VOC abatement units will be fitted with differential pressure

monitoring, conductivity alarms and will contain an interlock in order to prevent

high levels of sodium and chloride ending up in the main WWTP.

As outlined in Section 5.3.1, the proposed development also relates to the

installation of one non-thermal end-of-line VOC abatement unit (to be located

external to Building 3), to abate potential solvent emissions from the proposed

extended TIC. The proposed TIC extension would facilitate the potential

introduction of additional new production processes, at a future time. These

processes would likely be similar to those already conducted on site.

The VOC emissions emanating from the proposed extended TIC coating process

in Building 3 will exhaust to an end-of-line non-thermal solvent abatement unit,

which is likely to be located externally to Building 3.

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The non-thermal end-of-line VOC abatement unit will utilise an existing vent

stack located on the roof of Building 3. Emissions will be limited in accordance

with Best Available Technology.

A number of new dust emission points are proposed as part of the proposed

development. These will be positioned at various locations and will emit in

accordance with current licence limits for dust emissions. The stack heights of all

new emission points will be minimised to the level of existing stacks, where

possible.

As outlined in Section 5.3.3, the existing solvent tank farm will be repurposed for

the storage of Methanol & Acetone. A new acetone waste tank will be located at

the existing solvent tank farm.

In addition, two new storage tanks will be provided adjacent to Building 7 - One

new bulk chlorinated waste storage tank (for waste from the Reverse Osmosis

scrubbing process for the end-of-line VOC abatement units) and one new caustic

tank.

A new steam boiler will be installed in the existing Central Utilities Building

(Building 5) to support the GITS manufacturing process. The boiler will normally

run on natural gas. In the event of interruption of the gas supply to the site a back-

up diesel oil (<0.2% sulphur) supply will be used. The boiler combustion unit will

be fitted with a low NOX burner (burner which produces low concentrations of

nitrogen oxides) to ensure the potential for formation of NOX in the air emissions

is kept to a minimum.

The introduction of new production processes is likely to give rise to an increased

quantity of trade and foul wastewater produced on-site, during the operational

phase of the proposed development. An increase in the licenced volume of

wastewater discharged from the site will be included in the scope of the IE

Licence Review for the proposed development.

All wastewater will be discharged to the existing on-site wastewater treatment

plant for treatment, prior to discharge to the municipal sewer. It has been

determined that the existing on-site main WWTP has sufficient capacity to

facilitate the proposed development and subsequent increase in the volume of

wastewater discharges. All process effluent will be compliant with the limits

outlined in Directive 2010/75/EU of the European Parliament and the Council on

industrial emissions (‘the Industrial Emissions Directive’). Refer to Section 6.2.5

for further information on potential effects on trade and foul water effluent.

No changes to surface water discharges are expected due to the proposed

development as no additional hardstanding areas are proposed.

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6 Characteristics of Potential Effects

6.1 Construction Phase

6.1.1 Population and Human Health

6.1.1.1 Population

The proposed development will give rise to the temporary employment of a small

number of construction staff, as well as the employment of those involved in the

installation of the proposed new facilities and equipment.

The provision of new job opportunities and income to the local area is predicted to

result in a potential temporary, positive effect on the population.

6.1.1.2 Human Health

As outlined in Section 5.3, the proposed development will give rise to limited

construction works. However, there is potential for construction works to cause

limited disruption to nearby residents, road users and pedestrians during the

proposed works.

There is also the potential for the proposed construction works to give rise to

some noise and dust emissions as described in Section 6.1.5 and Section 6.1.6

below.

However, in considering the nature and scale of the proposed construction works,

which will predominately be completed within buildings as opposed to outside of

buildings, it is not considered that any potential noise or air emissions would be

significant. Further, best construction practice will be implemented to ensure that

noise and dust emissions will be kept within the required limits and a traffic

management plan will be implemented for the duration of the construction works.

The proposed development therefore has the potential to give rise to a slight

negative, temporary effect on human health during the construction phase.

6.1.2 Biodiversity

As outlined in Section 4.3.2, the Pfizer Newbridge site consists mainly of

buildings and artificial surfaces, with limited biodiversity. In considering the

existing baseline, as well as the nature and scope of the proposed construction

works, it is not considered that the construction phase of the proposed

development will give rise to a significant negative impact on biodiversity.

As outlined in Section 4.3.2, a number of designated sites are located within 5km

of the proposed development, but do not occur within the sphere of influence of

the project site. No Source-Pathway-Receptor link, be it hydrological, aerial or

mobile species linking the proposed development to designated sites in the wider

surrounding area has been identified.

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In considering the nature and scale of the proposed construction works and the

absence of any potential impact pathways, no potential likely significant effect on

any of the identified designated sites is predicted.

A report for the purposes of Appropriate Assessment (AA) Screening has been

prepared to determine the potential for impacts on Natura 2000 sites in respect of

the proposed development. As outlined in the report, it is Arup’s determination

that it is possible to exclude, on the basis of objective information and beyond

reasonable scientific doubt, that the development, alone or in combination with

other plans projects will have significant effects on any Natura 2000 sites, and

therefore it is the view of Arup that it is not necessary to undertake any further

stage of the Appropriate Assessment process.

6.1.3 Land and Soils

As described in Section 5, the construction works relating to the proposed

development will be minimal and restricted largely restricted to the internal

retrofitting of existing buildings.

The proposed installation of the new storage tanks and the non-thermal end-of-

line VOC abatement unit and steam boiler will however require some minor

groundworks in order to connect the installations to existing site services and

utilities. However, the depth of excavations required to facilitate these works is

predicted to be minor and all works will take place on the existing Pfizer

Newbridge site. In considering that the land-use classification of the site is that of

‘artificial surfaces’ and that it is underlain by ‘made ground’, it is not predicted

that the proposed groundworks would have the potential to result in a significant

negative effect on the land or soil.

The accidental spillage of fuels, oils, paints and solvents during the construction

phase could result in a potential impact on soil should it be allowed to infiltrate

the ground and groundwater.

However, all possible measures shall be made to protect the soils, bedrock

geology and hydrogeology of the site during construction. All oils, solvents and

paints used will be stored within specially constructed dedicated temporary

bunded areas. Refuelling of construction vehicles and the addition of hydraulic

oils or lubricants to vehicles will take place in a designated area of the site, away

from surface water gulley’s or drains.

If a spill or leak were to occur on site during the construction phase of the

proposed development, it will be collected in either the process wastewater or the

storm water drainage systems, depending on the location of the spill or leak.

If spilled or leaked process materials enters the storm water drainage system they

would be detected by the continuous TOC monitoring system, and the penstock

would automatically close thereby preventing discharge from the site. This

retained surface water would be further analysed to determine the nature and



would drain to the main WWTP and would be fully treated on site.

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As such, the construction phase of the proposed development is not predicted to

result in potential for significant negative effects on land and soils.

6.1.4 Water

As described in Section 5, the construction works relating to the proposed

development will be minimal, and primarily restricted to the internal retrofitting

of existing buildings.

The construction phase of the proposed development will not give rise to any

additional surface water run-off to which is already generated on site. Any surface

water collected during the construction phase of the proposed development will be

collected through the sites existing systems of systems of storm water drains for

treatment at the main WWTP on-site.

As outlined in Section 6.1.3, should a spill or leak occur on site during the

construction phase of the proposed development, it will be collected in either the

process wastewater or the storm water drainage systems, depending on the

location of the spill or leak. If spilled or leaked process materials enters the storm

water drainage system they would be detected by the continuous TOC monitoring

system, and the penstock would automatically close thereby preventing discharge

from the site. This retained surface water would be further analysed to determine

the nature and extent of contamination and establish an appropriate means of

disposal. If spilled or leaked process materials enter the process wastewater

drainage system, they would drain to the main WWTP on-site and would be fully

treated on site.

No potential for significant negative effects on water has been identified as a

result of the construction phase of the proposed development.


As outlined in Section 5, the construction phase of the proposed development will

involve minimal construction works at the site primarily relating to the internal

retrofitting of existing buildings.


line VOC abatement unit and steam boiler will require some minor groundworks

in order to connect the installations to existing site services and utilities. However,

the depth of excavations required to facilitate these works is predicted to be minor

and all works will take place on the existing Pfizer Newbridge site.

Given the range of activities currently on-site and the noise levels associated with

each, as well as baseline noise levels (Refer to Section 4.3.5), activities associated

with the construction phase, including the proposed minor groundworks, are not

expected to add to any notable levels of noise beyond the Pfizer Newbridge site

boundary.

The flow of construction traffic to and from the Pfizer Newbridge facility is also a

potential source of elevated noise levels. However, as outlined in Section 6.1.7, it

is expected that construction traffic generated during the construction phase of the

proposed development will be limited.

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As such, no potential significant negative noise impacts are predicted at nearby

sensitive receptors during the construction phase of the proposed development.

As such, it is not considered that there will be potential for significant negative

vibration effects during the construction phase of the proposed development.


There is the potential for emissions to atmosphere during the construction phase

of the proposed development. In particular, construction activities may generate

quantities of dust in the immediate region of the construction facility. However, in

considering the nature and scale of the proposed construction works which will

predominately completed within buildings as opposed to outside of buildings, no

significant negative potential effect on air quality is predicted.

The movement of construction vehicles to and from the Pfizer Newbridge site will

also give rise to potential effects on air quality. However, as outlined in Section

6.1.7 below, the level of construction traffic which will be generated as a result of

the construction phase of the proposed development will be minimal. As such, no

significant effect on air quality is predicted.


Typical construction working hours will be from 08.00 to 17.30 Monday to

Friday. The estimated length of time for all construction works to be completed is

9 months.

As outlined in Section 5, the construction works relating to the proposed

development will be minimal, and primarily restricted to the internal retrofitting

of existing buildings.

As such, the number of construction staff and construction related vehicles will

not be significant.

Construction traffic will largely consist of construction staff vehicles, material

deliveries and general plant and machinery such as Heavy Goods Vehicles

(HGVs), lifting and hoisting equipment etc. Access for construction traffic to the

Pfizer Newbridge site will be via existing access routes. The Pfizer Newbridge

facility is currently accessed via an entrance located on the western boundary of

the site, and a signalised junction at the north-eastern corner of the site.

Where it is deemed necessary, the works will be subject to a Construction Stage

Temporary Traffic Management Plan, to be agreed with Kildare County Council

and An Garda Síochána. This plan will identify proposals for the transportation of

staff to and from the site.

The quantum of parking required for construction staff will be facilitated by

existing car parking facilities at the Pfizer Newbridge site.

No significant effect on traffic and transportation is therefore predicted as a result

of the construction phase of the proposed development.

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As outlined in Section 4.3.8, the proposed development will take place entirely

within the existing envelope of the Pfizer Newbridge facility. No acquisition of

land will be required for the proposed development to proceed.




it is not expected that the proposed groundworks would result in any disruption to

the existing services or utilities.

As such, it is not predicted that the proposed development will result in an effect

on material assets during construction.


It is anticipated that construction activities, in particular the retrofitting of existing

buildings, will generate a range of waste materials including wood, steel, plastic,

waste paint etc. In considering the nature and scale of the proposed construction

works, the quantity of construction waste which will be generated during the

construction phase of the proposed development is not predicted to be significant.

In accordance with Pfizer Newbridge waste management procedures, he

appointed construction contractor will be required to operate a segregation system

on site, such that each waste is segregated in separate covered skips, within a

dedicated waste management area. Materials will be sent off-site for recycling

where possible, or to an appropriate waste management facility.

As such, no significant negative potential effect on waste management is

predicted as a result of the proposed development.

6.1.10 Archaeology, Cultural and Architectural Heritage

As outlined in Section 4.3.10, one Recorded Monument is noted within the Pfizer

Newbridge site- KD023-110, which is classified as a ‘burial’. The monument was

removed from the site following its discovery in 2004. As such, the proposed

construction works are not expected to have any effect on features of

archaeological significance.





and all works will take place on the existing Pfizer Newbridge site. In considering

that the land-use classification of the site is that of ‘artificial surfaces’ and that it

is underlain by ‘made ground’ with no record of sub-surface archaeology, it is not

predicted that the proposed groundworks would have the potential to result in a

significant negative effect on archaeology. No Protected Structures have been

identified on, or in close proximity to the site.

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As such, it is not considered that the proposed development has the potential to

give rise to significant negative effects on archaeology, architectural or cultural

heritage.


Proposed construction works will not result in any significant negative effect on

the landscape. All development will take place on the existing artificial surfaces

of the Pfizer Newbridge site, and within the existing envelope.





and all works will take place on the existing Pfizer Newbridge site. In considering

that the land-use classification of the site is that of ‘artificial surfaces’ and that it

is underlain by ‘made ground’, it is not predicted that the proposed groundworks

would have the potential to result in a significant negative effect on the existing

landscape.

With regards to the potential for visual impact, the construction phase of the

proposed development will result in the presence of significant plant and materials

on site, including either fixed or mobile cranes for use in the construction of the

proposed new vent stacks. However, it is expected that the existing landscaping

berms at the Pfizer Newbridge facility will work to screen the majority of

construction related visual impacts, with the exception of any fixed or mobile

cranes.

A potential temporary, minor negative visual effect is therefore predicted during

the construction phase of the proposed development.

6.1.12 Risk of Major Accident and/or Disasters

The construction phase of the proposed development is likely to give rise to an

increased risk of major accidents due to the use of large, mobile machinery and

heavy equipment and materials.

However, it is expected that standard best practice construction measures will be

implemented by the contractor during construction which will reduce the risk of

accidents occurring. All works will also be carried out in accordance with the

Safety, Health, and Welfare at Work (Construction) Regulations, 2006 (SI No.

504 of 2006). Further, all works will be carried out within the perimeter of the

Pfizer Newbridge facility with no uninvited public access permitted.

If a spill or leak were to occur on site during the construction phase of the

proposed development, it will be collected in either the process wastewater or the

storm water drainage systems, depending on the location of the spill or leak.

If spilled or leaked process materials enters the storm water drainage system they

would be detected by the continuous TOC monitoring system, and the penstock

would automatically close thereby preventing discharge from the site.

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This retained surface water would be further analysed to determine the nature and



would drain to the main WWTP on-site and would be fully treated on site.

As such, it is considered that the construction phase of the proposed development

has the potential to give rise to a temporary, minor increased risk of major

accidents occurring on site.

6.2 Operational Phase

6.2.1 Population

The proposed development is expected to give rise to approximately 80 new

permanent manufacturing and production jobs at the Pfizer Newbridge facility.

The provision of new job opportunities and income in the local area has the

potential to give rise to a likely significant, permanent and positive effect on the

population.

6.2.2 Human Health

A significant level of existing infrastructure is currently in place at the Pfizer

Newbridge facility to minimise the potential for operations to result in

contamination to the surrounding environment, and subsequent potential impact

on human health.

The introduction of the proposed two end-of-line VOC abatement units (thermal

oxidation) and the non-thermal end-of-line VOC abatement unit will result in

improved abatement of atmospheric emissions than the existing abatement

system. Further, the operational phase of the proposed development will be

according to BAT principals and in compliance with the licence for the site to

ensure that there would be no contamination or pollution of the ambient

environment.

With this infrastructure in place and associated procedures for treating and

managing potential emissions generated on site, it is not considered that the

operational phase of the proposed development will give rise to a significant

negative impact on human health.

6.2.3 Biodiversity

As outlined in Section 4.3.2, the Pfizer Newbridge site consists mainly of

buildings and artificial surfaces, with limited biodiversity. In considering the

existing baseline, as well as the nature and scope of the proposed development, it

is not considered that the operational phase of the proposed development will give

rise to a significant negative impact on biodiversity.

As outlined in Section 4.3.2, a number of designated sites are located within 5km

of the proposed development, but do not occur within the sphere of influence of

the project site.

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No Source-Pathway-Receptor link, be it hydrological, aerial or mobile species

linking the proposed development to designated sites in the wider surrounding

area has been identified. The absence of any potential impact pathways, coupled

with the approach to the management of operations and emissions generated from

the proposed development site will ensure that there is no potential for the

operational phase of the proposed development to result in a likely significant

effect on any of the identified designated sites.

A report for the purposes of Appropriate Assessment (AA) Screening has been

prepared to determine the potential for impacts on Natura 2000 sites in respect of

the proposed development. As outlined in the report, it is Arup’s determination

that it is possible to exclude, on the basis of objective information and beyond

reasonable scientific doubt, that the development, alone or in combination with

other plans projects will have significant effects on any Natura 2000 sites, and

therefore it is the view of Arup that it is not necessary to undertake any further

stage of the Appropriate Assessment process.

6.2.4 Land and Soils

The operational phase of the proposed development will be according to BAT

principles and in compliance with the licence for the site to ensure that inputs to,

and subsequent contamination of the land and soil does not occur during normal

and/or emergency conditions.

All bulk solvents used or generated as part of the proposed development will be

stored in the proposed additional above ground solvent tanks, which will be

located in bunds, in the existing Solvent Tank Farm. The Solvent Tank Farm is

concreted with properly sealed joints to prevent the potential for leaks or spills.

Liquid process materials in smaller quantities will be stored in drums or

intermediated bulk containers, in bunded Chemstores. The Chemstores will be

located either in designated outdoor impermeable paved areas (pads) or in the

Solvent Storage Area located within Building 4.

Further, the spill control procedures that are already in place at the Pfizer

Newbridge facility for solvent & diesel tanker loading/unloading will be applied

to the operations relating to the proposed development.

It is therefore not considered that the operational phase of the proposed

development has the potential to give rise to significant negative effects on land or

soil.

6.2.5 Water


principles and in compliance with the licence for the site to ensure that inputs to,

and subsequent contamination of the water environment does not occur during

normal and/or emergency conditions.

As outlined in Section 6.2.4, all bulk solvents used or generated as part of the

proposed development will be stored in the proposed additional above ground

solvent tanks, which will be located in bunds, in the existing Solvent Tank Farm.

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The Solvent Tank Farm is concreted with properly sealed joints to prevent the

potential for leaks or spills.

Liquid process materials in smaller quantities will be stored in drums or

intermediated bulk containers, in bunded Chemstores. The Chemstores will be

located either in designated outdoor impermeable paved areas (pads) or in the

Solvent Storage Area located within Building 4.

Further, the spill control procedures that are already in place at the Pfizer

Newbridge facility for solvent and diesel tanker loading/unloading will be applied

to the operations relating to the proposed development.

No potential effects on surface water is therefore identified during the operational

phase of the proposed development.

6.2.5.1 Trade & Foul Effluent

The operational phase of the proposed development will give rise to an increase of

123m3/day waste water effluent discharged to public sewer, representing an

increase of 15.8% in volume to the existing discharge. An increase in the licenced

volume and flow of wastewater discharged from the site will be included in the

scope of the IE Licence Review for the proposed development.

As outlined in Section 5.4, Hydrochloric Acid (HCL) and Chlorine (CL) are

formed when DCM is thermally oxidised. In order to remove HCL and CL from

the internal airstream, the end-of line VOC abatement units will require the use of

a water-based solution, containing caustic and sodium bisulfite,

This removal process (scrubbing) will result in the formation of a waste stream

consisting of a salt solution with some excess caustic and sodium bisulphite, or

some excess HCl, depending on the pH point at which the scrubber blowdown is

discharged.

It is proposed that the scrubbing waste stream will be concentrated to remove a

significant proportion of the water, which will be discharged to the existing on-

site main WWTP for treatment, prior to discharge to the municipal sewer. The

concentrated waste will then be transferred to a bulk storage tank adjacent to

Building 7 for storage and subsequent removal from site for disposal.

The end-of-line VOC abatement units will be fitted with differential pressure

monitoring, conductivity alarms and will contain an interlock in order to prevent

high levels of sodium and chloride ending up in the main WWTP.

Boiler blowdown will be generated from the new steam boiler.

It has been determined that the existing on-site main WWTP has sufficient

capacity to facilitate the proposed development and subsequent increase in the

volume of wastewater discharges.

All process effluent will be compliant with the limits outlined in Directive

2010/75/EU of the European Parliament and the Council on industrial emissions

(‘the Industrial Emissions Directive’).

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6.2.5.2 Surface Water Drainage

The discharge of surface water generated on site is controlled via the existing

storm water drainage system prior to release from the site and eventual discharge

to the River Liffey. The approach to surface water management on site has to date

ensured that the release of surface water does not have the potential to negatively

affect the surface water quality of the River Liffey or Dublin Bay downstream.

This approach to the treatment of surface water will be continued as part of the

proposed development.


The potential for noise generation during the operational phase of the proposed

development relates to new process machinery, the two-proposed end-of-line

VOC abatement units (thermal oxidation), the non-thermal end-of-line VOC

abatement unit, AHU’s, drying ovens and the proposed 4 No centrifugal pumps

located in the tank farm.

The potential noise impacts relating to the operation of the proposed. end-of-line

VOC abatement units principally derive from noise generated from operation of

fans associated with the equipment.

However, the operational phase of the proposed development will be in

accordance with BAT principles, and in compliance with the IE licence for the

site to ensure that inputs to, and subsequent contamination of the ambient

environment does not occur during normal and/or emergency conditions. The

noise limits set out in the facility’s existing IE Licence, and as reproduced in

Table 4.2 in Section 4.3.5.2. It should be noted that as part of the review of the

existing IE licence, a new evening time limit of 50dBLAeq is likely to be

implemented.

Further, given the range of activities currently on-site and the noise levels

associated with each, as well as baseline noise levels (Refer to Section 4.3.5),

activities associated with the operational phase are not expected to add to any

notable levels of noise beyond the site boundary.

Additional vehicular traffic on public roads also has the potential to result in

increased noise levels at the Pfizer Newbridge site, and nearby sensitive receptors.

However, as outlined in Section 6.2.8, there will be no increase in traffic on local

road networks during the operational phase of the proposed development. As

such, no potential significant negative noise effect of the proposed development

on nearby sensitive receptors is predicted.

The operation of the proposed development is not anticipated to result in any

significant vibration impacts.

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principles and in compliance with the IE licence for the Pfizer Newbridge site to

ensure that inputs to, and subsequent contamination of the atmospheric

environment does not occur during normal and/or emergency conditions.

As outlined in Section 5, the proposed development involves the introduction of a

number of additional atmospheric emission points. Proposed chlorinated

atmospheric emissions will be generated from the following activities during

GITS production:

• Membrane coating;

• Solvent coating and solution preparation;

• Laser drilling;

• Oven Drying;

• DCM and Waste Storage.

Potential non-chlorinated atmospheric emissions will be generated from the

following activities:

• Membrane coating;

• Solvent coating and solution preparation;

• Fluid bed drying- granulation;

• Oven drying;

• Acetone, methanol and waste storage.

All proposed new atmospheric emissions (solvent, dust, boiler) will be compliant

with the ELVs set out in the Pfizer Newbridge facility existing/amended IE

Licence and will comply with relevant BAT limits.

The proposed development relates to the introduction of a number of new dust

emission points. These will be located on the roof of Building 3C and will

measure 21m above ground level. All dust emissions will be compliant with the

emission limit values outlines in the site’s IE Licence.

The proposed development will reuse the existing stack on site that measures 28m

above ground level for the proposed emissions from the end-of-line VOC

abatement units.

As outlined in Section 6.2.8 below, the operational phase of the proposed

development is not predicted to give rise to an increase in traffic on the local road

network. As such, no significant increase in traffic or subsequent emissions are

predicted during the operational phase of the proposed development.

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During the operational phase of the proposed development it is anticipated that the

number of personnel working in the new manufacturing areas would amount to

approximately 1,000 persons (approximately 830 staff + 170 contractors). It

should be noted that prior to 2010, the number of personnel working on site

amounted to approximately 1,900 personnel (1,400 staff + 500 contractors).

The increase in the number of personnel accessing and egressing the Pfizer site is

predicted to amount to approximately 80 staff. No subsequent significant increase

in traffic is predicted during the operational phase of the proposed development.

It is considered that the existing parking facilities at the Pfizer Newbridge facility

will provide for any increase in parking requirements.

As such, no potential significant negative effect on traffic and transportation is

predicted during the operational phase of the proposed development.


The proposed development is likely to result in a minor increase in demand on the

local electricity, gas and water supply. However, it is expected that the relevant

service networks have capacity to accommodate the proposed development.

It is therefore not considered that the proposed development has the potential to

give rise to a significant negative effect on material assets during operation.


Existing site procedures for the management (storage, transport, off-site

recycling/recovery/disposal) of hazardous and non-hazardous waste generated at

the Pfizer site will also apply to waste generated during the construction and

operational phases of the proposed development. These procedures are in

compliance with Condition 8 and Schedule C of the Pfizer Newbridge IE Licence.

All waste generated will be collected and stored in designated waste storage areas

prior to removal by an appropriately licensed waste management contractor for

off-site recycling/recovery/disposal. No waste will be disposed of at the Pfizer

Newbridge site.

In accordance with Pfizer Newbridge environmental objectives, every effort will

be made to minimise the quantity of waste generated during the construction and

operational phases of the proposed development. Notwithstanding this a slight

increase in the quantity of waste produced on site is predicted as a result of the

operational phase of the proposed development. The waste management

contractor (and the waste facilities that they use) for the

recycling/recovery/disposal of waste generated from the Pfizer Newbridge facility

have the capacity to accept and treat any waste generated during the construction

and operational phases of the proposed development.

It is therefore considered that the operational phase of the proposed development

will not give rise to potential significant negative effects on waste management.

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6.2.11 Archaeology, Architectural and Cultural Heritage

The operational phase of the proposed development has no potential to give rise to

negative effects on archaeology, architectural or cultural heritage.


As previously outlined, the proposed development provides for the introduction of

a number of new particulate (dust) emission points. These will be located on the

roof of Building 3C-2 and will measure 21m (above ground). The height of the

proposed new emission points will be lower than emission points already installed

at this location.

The VOC emissions emanating from the new GITS manufacturing processes in

Building 3C-2 will exhaust to the existing main vent stack at Building 8

(previously used for boiler emissions).

As outlined in Section 5.3.3, the existing solvent tank farm will be repurposed for

the storage of Methanol & Acetone. A new acetone waste tank will be located at

the existing solvent tank farm.

The proposed development also provides for the installation of a Caustic Storage

Tank and a Chlorinated Waste Storage Tank (located adjacent to Building 7). All

proposed bulk storage tanks will measure 8m in height (above ground), which is

the same height as the existing tanks located at the Solvent Tank Farm.

The VOC emissions emanating from the new manufacturing processes associated

with the extended TIC in Building 3 will exhaust to an end-of-line non-thermal

solvent abatement unit (which is likely to be located externally to Building 3). The

non-thermal end-of-line VOC abatement unit will utilise an existing vent stack

located on the roof of Building 3.

Existing landscaping at the Pfizer Newbridge site consists of planted berms, trees

and hedgerows. While it is expected that these will provide a level of screening, it

is predicted that the new vent stacks proposed as part of the proposed

development will still be visible from certain external viewpoints.

The proposed development is in keeping with the land use zoning for the area (i.e.

industrial and warehousing) and no change to the building façade is proposed.

In considering the semi-urban context of the proposed development as well as the

existing screening, a permanent, minor negative visual impact of the proposed

development (as is currently the case for these existing buildings) will continue

during the operational phase of the proposed development, given that the

proposed development will be constructed within the footprint of existing building

structures.

6.2.13 Risk of Major Accident and/or Disaster

The proposed development has the potential to give rise to an increased risk of

major accident occurring during the operational phase of the development.

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As outlined in Section 4.3.12.2, the existing Pfizer Newbridge facility is not

classified as either a lower or upper tier facility under the European Communities

(Control of Major Accident Hazards Involving Dangerous Substances)

Regulations, and the introduction of the proposed development will not result in

any change to this non-classification.

The existing environmental management and control systems currently employed

on site will also apply to the proposed development (Refer to Section 6.1.3 and

6.1.2). For this reason, while the potential exists for chemical spills relating to the

proposed new tanks associated with the proposed development, no significant risk

of a major accident or disaster from chemical spills or leaks is predicted during

the operational phase of the proposed development.

As described in Section 5, the proposed development includes the installation of 2

No. end-of-line VOC abatement units (1 No. Thermal Oxidizer for Non-

Chlorinated VOCs and 1 No. Thermal Oxidizer for Chlorinated VOCs).

As with any thermal abatement of VOCs, potential malfunctions associated with

the vent collection systems and thermal oxidisers associated with the proposed

development have the potential to result in fire and explosion hazards, such as:

• Interruption to power supply;

• Instrumentation problems;

• Control system problems;

• Mixing of vent streams;

• Reduction in air flow rates;

• Fluctuations in VOC flow rates;

• Process deviations;

• Bringing new vessels or processes on line.

A HAZOP or process hazard review will be carried out as part of the detailed

design for the proposed development, in order to ensure that the safety and

integrity of the system has not been compromised and that any changes in

operating conditions have been taken into account. The end-of-line VOC

abatement units associated with the proposed development represent established

technology, which has proven successful in terms of safety requirements, where

used in similar settings. Furthermore, the end-of-line VOC abatement units

associated with the proposed development will be fitted with explosion relief in

the form of high intensity control and safety systems. The likelihood of a fire or

explosion occurring at either of the proposed end-of-line VOC abatement units is

therefore considered low.

The non-thermal VOC abatement unit associated with the extended TIC at

Building 3 will also be fitted with high intensity control and safety systems. The

likelihood of a fire or explosion occurring at this abatement unit is therefore

considered low.

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The Pfizer Newbridge facility will continue to operate in compliance with all Irish

and European regulations governing safety in the work place with specific regard

to the regulations implemented under the Safety, Health & Welfare at Work Act,

2005.

As such, the operational phase of the proposed development is not considered to

give rise to potential significant risks of major accidents or disasters.

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7 Screening Checklist

The potential environmental effects associated with the proposed development has

been outlined in the previous sections of this report.

The EC Guidance on EIA Screening (EC, 2017) provides a checklist to help users

decide whether EIA is required based on the characteristics of a project and its

environment. This screening checklist is included in Table 7.1.

Table 7.1: Screening Checklist to determine if EIA is required based on the

characteristics of a project and its environment

Brief Project Description Yes/No Is this likely to result in a significant impact

Yes/No - Why

1. Will construction, operation or

decommissioning of the project involve

actions which will cause physical

changes in the locality (topography,

land use, changes in waterbodies, etc.)?

No No.

The proposed development will take place entirely

within the envelope of the existing Pfizer Newbridge

site. The site is currently industrial by nature and

comprised of ‘artificial surfaces.’

2. Will construction or operation of the

project use natural resources such as

land, water, materials or energy,

especially any resources which are

non-renewable or in short supply?

Yes No.

The operational phase of the proposed development

will result in an increase in demand on the local

water, electricity and gas supply. However, it is

considered that the relevant service providers have

sufficient capacity to meet these demands.

3. Will the project involve use, storage,

transport, handling or production of

substances or materials which could be

harmful to human health or the

environment or raise concerns about

actual or perceived risks to human

health?

Yes No.

Existing site procedures for the management (storage,

transport, off-site recycling/recovery/disposal) of

hazardous and non-hazardous waste generated at the

Pfizer Newbridge site will also apply to waste

generated during the construction and operational

phases of the proposed development. These

procedures are in compliance with Condition 8 and

Schedule C of the Pfizer Newbridge IE Licence. All

waste generated will be collected and stored in

designated waste storage areas prior to removal by an

appropriately licensed waste management contractor

for off-site recycling/recovery/disposal. No waste

will be disposed of at the Pfizer Newbridge site.

In accordance with Pfizer Newbridge environmental

objectives, every effort will be made to minimise the

quantity of waste generated during the construction

and operational phases of the proposed development.

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Yes/No - Why

Notwithstanding this a slight increase in the quantity

of waste produced on site is predicted as a result of


The waste management contractor (and the waste

facilities that they use) for the

recycling/recovery/disposal of waste generated from

the Pfizer Newbridge facility have the capacity to

accept and treat any waste generated during the

construction and operational phases of the proposed

development.

4. Will the project produce solid wastes

during construction or operation or

decommissioning?

Yes No.

It is anticipated that construction activities, in

particular the internal retrofitting of existing

buildings, will generate a range of waste materials

including wood, steel, plastic, waste paint etc. In

considering the nature and scale of the proposed

construction works, the quantity of construction

waste which will be generated during the

construction phase of the proposed development is

not predicted to be significant.

The appointed contractor will be required to operate a

segregation system on site, such that each waste is

segregated in separate covered skips, within a

dedicated waste management area. Materials will be

sent off-site for recycling where possible, or to an

appropriate waste disposal facility.


will be carried out in compliance with Condition 8

and Schedule C of the Pfizer Newbridge IE Licence.

To this end by strictly adhering to plant operating

instructions, no significant negative potential effect

on waste management is predicted as a result of the

proposed development.

5. Will the project release pollutants or

any hazardous, toxic or noxious

substances to air or lead to exceeding

Ambient Air Quality standards in

Directives 2008/50/EC and

2004/107/EC?

Yes No.


will be according to BAT principles and in

compliance with the licence for the site to ensure that

inputs to, and subsequent contamination of the

atmospheric environment does not occur during

normal and/or emergency conditions.

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Yes/No - Why

As outlined in Section 5, the proposed development

involves the introduction of a number of additional

dust emission points.

All proposed new atmospheric emissions will be

compliant with the ELV’s set out in the Pfizer

Newbridge facility’s existing/amended IE Licence

and will comply with relevant BAT limits.

6. Will the project cause noise and

vibration or release of light, heat

energy or electromagnetic radiation?

Yes No.

As outlined in Section 5, the construction phase of

the proposed development will involve minimal

construction works at the site primarily relating to the

internal retrofitting of existing buildings

The proposed installation of the new storage tanks

the non-thermal end-of-line VOC abatement unit and

the steam boiler will require some minor

groundworks in order to connect the installations to

existing site services and utilities. However, the depth

of excavations required to facilitate these works is

predicted to be minor and all works will take place on

the existing Pfizer Newbridge site.

Given the range of activities currently on-site and the

noise levels associated with each, as well as baseline

noise levels (Refer to Section 4.3.5), activities

associated with the construction phase are not

expected to add to any notable levels of noise beyond

the site boundary.

The flow of construction traffic to and from the

Pfizer Newbridge facility is also a potential source of

elevated noise levels. However, as outlined in Section

6.1.7, it is expected that construction traffic generated

during the construction phase of the proposed

development will be limited.

The potential for noise generation during the

operational phase of the proposed development

relates to process machinery, in particular the

proposed. end-of-line VOC abatement units, AHU’s,

drying ovens and the proposed 4 No centrifugal

pumps located in the tank farm.

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Yes/No - Why

However, the operational phase of the proposed

development will be in accordance with BAT

principles, and in compliance with the licence for the

site to ensure that inputs to, and subsequent

contamination of the ambient environment does not

occur during normal and/or emergency conditions.

The noise limits set out in the facility’s existing IE

Licence, and as reproduced in Table 4.2 in Section

4.3.5.2. It should be noted that as part of the review

of the existing IE licence, a new evening time limit of

50dBLAeq is likely to be implemented.

Further, given the range of activities currently on-site

and the noise levels associated with each, as well as

baseline noise levels (Refer to Section 4.3.5),

activities associated with the operational phase are

not expected to add to any notable levels of noise

beyond the site boundary.

Additional vehicular traffic on public roads also has

the potential to result in increased noise levels at the

Pfizer Newbridge site, and nearby sensitive receptors.

However, as outlined in Section 6.2.8, there will be

no increase in traffic on local road networks during


7. Will the project lead to risks of

contamination of land or water from

releases of pollutants onto the ground

or into surface waters, groundwater,

coastal wasters or the sea?

No No.

If a spill or leak were to occur on site during the

construction or operational phase of the proposed

development, it will be collected in either the process

wastewater or the storm water drainage systems,

depending on the location of the spill or leak.

If spilled or leaked process materials enters the storm

water drainage system they would be detected by the

continuous TOC monitoring system, and the penstock

would automatically close thereby preventing

discharge from the site.

This retained surface water would be further analysed

to determine the nature and extent of contamination

and establish an appropriate means of disposal. If

spilled or leaked process materials enter the process

wastewater drainage system, they would drain to the

on-site waste water pre-treatment plant (main

WWTP) and would be fully treated on site.

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Yes/No - Why

8. Will there be any risk of accidents

during construction or operation of the

project which could affect human

health or the environment?

Yes No.

The construction phase of the proposed development

is likely to give rise to an increased risk of major

accidents due to the use of large, mobile machinery

and heavy equipment and materials.

However, it is expected that standard best practice

construction measures will be implemented by the

contractor during construction which will reduce the

risk of accidents occurring. All works will also be

carried out in accordance with the Safety, Health, and

Welfare at Work (Construction) Regulations, 2006

(SI No. 504 of 2006). Further, all works will be

carried out within the perimeter of the Pfizer

Newbridge facility with no uninvited public access

permitted.

The proposed development has the potential to give

rise to an increased risk of major accident occurring

during the operational phase of the proposed

development.

Potential malfunctions on-site have the potential to

result in fire and explosion hazards in the thermal

oxidiser and vent collection systems.

A HAZOP or process hazard review will be carried

out prior to development, and periodically, to ensure

that the safety and integrity of the system has not

been compromised and that any changes in operating

conditions have been taken into account. Further, the

end-of-line VOC abatement units will be fitted with

explosion relief in the form of high intensity control

and safety systems.

The likelihood of a fire or explosion occurring at any

of the proposed end-of-line VOC abatement units is

therefore considered low.

The operation of the Pfizer Newbridge facility will

continue to operate in compliance with all Irish and

European regulations governing safety in the work

place with specific regard to the regulations

implemented under the Safety, Health & Welfare at

Work Act, 2005.

Refer to the above section for information regarding

risk of contamination of land, soil and water.

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Yes/No - Why

9. Will the Project result in social

changes, for example, in demography,

traditional lifestyles, employment?

Yes No.

The proposed development will result in an increase

in the number of people employed at the Pfizer

Newbridge site, creating job opportunities and

income in the local area.

10.Are there any other factors which

should be considered such as

consequential development which

could lead to environmental effects or

the potential for cumulative impacts

with other existing or planned activities

in the locality?

No No.

The proposed development is considered to be minor

in nature, and no potential for cumulative impacts

with other projects or development are therefore

identified.

11. Is the project located within or

close to any areas which are protected

under international, EU, or national or

local legislation for their ecological,

landscape, cultural or other value,

which could be affected by the project?

Yes No.

There are five sites of ecological significant located

within 5km of the proposed development. None of

the sites are directly connected to the proposed

development site. No recorded monuments or

protected structures are located within the existing


Given the nature and scale of the proposed

development, no potential negative effects on any of

these sites are predicted.

12. Are there any other areas on or

around the location which are

important or sensitive for reasons of

their ecology e.g. wetlands,

watercourses or other waterbodies, the

coastal zone, mountains, forests or

woodlands, which could be affected by

the project?

Yes No.

The nearest surface water body to the site is the River

Liffey located approximately 1km west of the site.

No potential negative effects on the River Liffey or

any other sensitive areas are predicted.

13. Are there any areas on or around

the location which are used by

protected, important or sensitive

species of fauna or flora e.g. for

breeding, nesting, foraging, resting,

overwintering, migration, which could

be affected by the project?

Yes No.

There are five sites of ecological significant located

within 5km of the proposed development. None of

the sites are directly connected to the proposed

development site. No recorded monuments or

protected structures are located within the existing




these sites or sensitive species are predicted.

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Yes/No - Why

14. Are there any inland, coastal,

marine or underground waters (or

features of the marine environment) on

or around the location that could be

affected by the project?

Yes No.

The nearest surface water body to the site is the River

Liffey located approximately 1km west of the site.

A Regionally Important Aquifer – Karstified (Rkd) of

high vulnerability is located under the Pfizer

Newbridge site. 2 no. private wells are located within

1 km of the Pfizer facility. One other well, which is

part of the Curragh Camp Public Water Supply is

located approximately 2.5km west north west of the

Pfizer site, in the townland of Cornelscourt.

The Curragh Camp Public Water Supply is the only

public water supply located within approximately 10

km of the Pfizer site in Newbridge.

The Pfizer Newbridge site is not located within a

source protection zone. The closest source protection

zone is located around 3 of the wells of the Curragh

Camp Public Water Supply at the Curragh camp,

5km to the southeast of the Pfizer site.


will be according to BAT principles and in


inputs to, and subsequent contamination of the water

environment does not occur during normal and/or

emergency conditions.

As outlined in Section 6.2.4, all bulk solvents used or

generated as part of the proposed development will

be stored in the proposed additional above ground

solvent tanks.

A number of measures are and will be in place for the

prevention of spills/leaks resulting in the

contamination of water features (see above sections).

All wastewater generated at the project site

undergoes treatment within the onsite state of the art

wastewater pre-treatment plant (main WWTP) prior

to discharge to the municipal sewer. In addition, the

effluent discharged to municipal sewer undergoes a

second round of treatment at the municipal

wastewater treatment plant at Osberstown prior to

final release to the River Liffey.

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Yes/No - Why

The discharge of surface water generated on site is

controlled via the existing storm water drainage

system prior to release from the site and eventual

discharge to the River Liffey.

15. Are there any areas or features of

high landscape or scenic value on or

around the location which could be


No No. The sensitivity of the Northern Lowlands is

deemed to be of ‘Low-Sensitivity’ and is defined as

an area ‘with the capacity to generally accommodate

a wide range of uses without significant adverse

effects on the appearance or character of the area.’

16. Are there any routes or facilities on

or around the location which are used

by the public for access to recreation or

other facilities, which could be affected

by the project?

No No. The proposed development will take place

entirely within the existing envelope of the Pfizer

Newbridge site, which is not publicly accessible.

17. Are there any transport routes on or

around the location which are

susceptible to congestion or which

cause environmental problems, which

could be affected by the project?

No No.

The Pfizer Newbridge facility is located

approximately 1km to the North East of Newbridge

town centre on the R445. The entrance to the existing

facility is located 85m southeast of Buckley’s

crossroads along the Greatconnell Road.

The R445, formerly the N7, formed the national

primary route from Dublin to Limerick until the

opening of the M7 motorway bypass of Newbridge.

This road has since been downgraded to a regional

road. The R445 now forms the most direct road from

Newbridge to Naas and provides access to the M7

motorway.

The number of construction staff and subsequent

number of construction related vehicles will not be

significant.

There will be no increase in the number of people

entering or egressing the Pfizer Newbridge site as a

result of the operational phase of the proposed

development.

18. Is the project in a location where it

is likely to be highly visible to many

people?

Yes No.

Existing landscaping at the Pfizer Newbridge site

consists of planted berms, trees and hedgerows.

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Yes/No - Why

While it is expected that these will provide a level of

screening, it is predicted that the proposed vent stacks

will still be visible from certain external viewpoints.

The proposed development is in keeping with the

land use zoning for the area and the nature and

character of the existing structures at the Pfizer

Newbridge site.

In considering the semi-urban context of the

proposed development as well as the existing

screening, a permanent, minor negative visual impact

of the proposed development is predicted during the

operational phase.

19. Are there any areas or features of

historic or cultural importance on or

around the location which could be


No No. There are no features of historical or cultural

importance located within the site of the proposed

development.



these sites or sensitive species are predicted.

20. Is the project located in a

previously undeveloped area where

there will be loss of greenfield land?



Newbridge site

21. Are there existing land uses on or

around the location e.g. homes,

gardens, other private property,

industry, commerce, recreation, public

open space, community facilities,

agriculture, forestry, tourism, mining

or quarrying which could be affected

by the project?

Yes No.

The proposed development will take place entirely

within the existing envelope of the Pfizer Newbridge

facility.

22. Are there any plans for future land

uses on or around the location which

could be affected by the project?

No No.

The proposed development is considered to be minor

in nature, and no potential for cumulative impacts

with other projects or development are therefore

identified.


the location which are densely

populated or built-up, which could be


Yes No.

The Pfizer facility at Newbridge is located

approximately 1km from Newbridge Town.

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Yes/No - Why


will be according to BAT principals and in


there would be no contamination or pollution of the

ambient environment.

With this infrastructure in place and associated

procedures for treating and managing potential

contamination and emissions generated on site, it is

not considered that the operational phase of the

proposed development will give rise to a significant

negative impact on population or human health at

Newbridge town.


the location which are occupied by

sensitive land uses e.g. hospitals,

schools, places of worship, community

facilities, which could be affected by

the project?



Newbridge site. No sensitive land uses are identified

within close proximity to the proposed development.

Further, it is not expected that the proposed

development will result in any negative effect on the

receiving environment.


the location which contain important,

high quality or scarce resources e.g.

groundwater, surface waters, forestry,

agriculture, fisheries, tourism,

minerals, which could be affected by

the project?

Yes No. The proposed development will take place


Newbridge site. It is not expected that the proposed

development will result in any negative effect on the

receiving environment.


the location which are already subject

to pollution or environmental damage

e.g. where existing legal environmental

standards are exceeded, which could be


No No.

No areas in close proximity to the existing

Newbridge site have been identified as being already

subject to pollution or environmental damage.

27. Is the project location susceptible

to earthquakes, subsidence, landslides,

erosion, flooding or extreme or adverse

climatic conditions e.g. temperature

inversions, fogs, severe winds, which

could cause the project to present

environmental problems?

No No.

The Draft Strategic Flood Risk Assessment (SFRA),

carried out as part of the Newbridge Local Area Plan

2013-2019, provides an assessment of flood risk in

the area to inform strategic land-use decisions.

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Yes/No - Why

The SFRA has recommended that development

proposals for the areas identified as being at risk of

flooding be subject to a site-specific flood risk

assessment.

The Pfizer Newbridge site is outside the 100-year

flood zone.

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8 Conclusions

The prescribed classes of development and thresholds that trigger a mandatory

EIAR are set out in Schedule 5 of the Planning and Development (Amendment)

Regulations 2001 – 2018. A review of the project types listed in Schedule 5 of the

Planning and Development (Amendment) Regulations 2001 – 2018 has been

carried out. It is considered that the proposed Building 3C-2 development at the

existing Pfizer Newbridge site does not correspond with any of the development

types listed in Schedule 5. Therefore, a mandatory EIAR is not required.

Section 92 of the Planning and Development Regulations, 2001, as amended

define sub-threshold development as follows:

“sub-threshold development’ means development of a type set out in

Schedule 5 which does not exceed a quantity, area or other limit specified

in that Schedule in respect of the relevant class of development;”

The existing Pfizer Newbridge facility is considered to be a class of development described under Section 10(b)(iv) of Part 2, Schedule 5 of the Planning and Development (Amendment) Regulations 2001 – 2018:

10.Infrastructure projects

(a) Industrial estate development projects, where the area would exceed 15 hectares.

(b) (i) Construction of more than 500 dwelling units.

(ii) Construction of a car-park providing more than 400 spaces, other than a car-park provided as part of, and incidental to the primary purpose of, a development.

(iii) Construction of a shopping centre with a gross floor space exceeding 10,000 square metres.

(iv) Urban development which would involve an area greater than 2 hectares in the case of a business district, 10 hectares in the case of other parts of a built-up area and 20 hectares elsewhere.

(In this paragraph, “business district” means a district within a city or town in which the predominant land use is retail or commercial use.)

The proposed development relates to an increase in production at the Pfizer

Newbridge facility of approximately 9%. As the existing Pfizer Newbridge

facility is considered to be a class of development described under Section

10(b)(iv) of Part 2, Schedule 5, it has therefore been determined that the proposed

development could be considered ‘sub-threshold development’ with regards to

Section 13(ii) of Part 2, Schedule 5, whereby:

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“13. Changes, extensions, development and testing

(a) Any change or extension of development already authorised, executed or in the process of being executed (not being a change or extension referred to in Part 1) which would: -

(i) result in the development being of a class listed in Part 1 or paragraphs 1 to 12 of Part 2 of this Schedule, and

(ii) result in an increase in size greater than – - 25 per cent, or - an amount equal to 50 per cent of the appropriate threshold, whichever is the greater.”

As such, under the provisions of Section 15 of Part 2, Schedule 5 of the Planning

and Development (Amendment) Regulations 2001 – 2018, Arup has prepared an

EIA Screening report which will provide the competent authority, Kildare County

Council, with the information necessary to undertake the EIA screening

assessment in respect of the proposed development.

The EIA screening contained herein includes an examination of whether the

proposed development would or would not, individually and in combination with

other development, be likely to have significant effects on the environment having

regard to the criteria set out in Schedule 7 of the Planning and Development

(Amendment) Regulations 2001 – 2018. Consideration has also been given in

relation to the requirements of Annex III of Directive 2014/52/EU.

In this respect, it is considered that the proposed development is not likely to have

significant effects on the environment having regard to the criteria set out in

Schedule 7 of the Planning and Development (Amendment) Regulations 2001 –

2018 and Annex III of Directive 2014/52/EU.

Based on the foregoing analysis of the characteristics of the development, its

proposed location and the characteristics of the potential effects, it is concluded

that the proposed development would not be likely to have significant effects on

the environment. Therefore, it is the view of Arup that an EIA is not required for

the proposed development.

The final determination as to whether an EIAR is required will be made by

Kildare County Council, as the competent authority, in its screening assessment.

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9 References

Department of Housing, Planning, Community and Local Government

(DoHPCLG), 2017. Transposition of 2014 EIA Directive (2014/52/EU) in the

Land Use Planning and EPA Licencing Systems. Dublin, Ireland.

DoHPCLG, 2017. Implementation of Directive 2014/52/EU on the effects of

certain public and private projects on the environment (EIA Directive): Advice on

the Administrative Provisions in Advance of Transposition. Dublin, Ireland.

Department of the Environment, Community and Local Government (DoECLG),

2013. Guidelines for Planning Authorities and An Bord Pleanála on carrying out

Environmental Impact Assessment. Dublin, Ireland.

Department of the Environment, Heritage and Local Government (DoEHLG),

2003. Environmental Impact Assessment (EIA) Guidance for Consent Authorities

regarding Sub-Threshold Development. Dublin, Ireland.

European Commission (EC), 2017. Environmental Impact Assessment of Projects

– Guidance on Screening. Office for Official Publications of the EC,

Luxembourg.

European Communities (Environmental Impact Assessment) (Amendment)

Regulations (S.I. No. 93 of 1999).

Environmental Protection Agency (EPA), 2015. Draft Revised Guidelines on the

Information to be contained in Environmental Impact Statements.

EPA, 2015. Draft Advice Notes for preparing Environmental Impact Statements.

EPA, 2003. Advice Notes on Current Practice in the Preparation of

Environmental Impact Statements. Johnstown Castle Estate, Wexford, Ireland.

EPA, 2002. Guidelines on the Information to be contained in Environmental

Impact Statements. Johnstown Castle Estate, Wexford, Ireland.

Planning and Development Act, 2000 (No. 30 of 2000), as amended.

Planning and Development Regulations, 2001 (S.I. No. 600 of 2001), as amended.

Transport Infrastructure Ireland, 2014. Good Practice Guidance for the Treatment

of Noise during the Planning of National Road Schemes.

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Pfizer Ireland Pharmaceuticals · 2019. 3. 7. · Pfizer Ireland Pharmaceuticals Building 3C-2 Development ... Directive 2011/92/EU, as amended 2014/52/EU (EIA Directive). ... by