baseline report in accordance with article 22(2) of the ... · baseline report for the proposed new...

18
GROUP Baseline Report in accordance with Article 22(2) of the Industrial Emissions Directive Issue date: 19 December 2013 Celebrating 40 Years in Business Jazz Pharmaceuticals Ireland Project Rock IE0311133-22-RP-0011, Issue: A For inspection purposes only. Consent of copyright owner required for any other use. EPA Export 30-12-2013:23:24:29

Upload: others

Post on 27-May-2020

7 views

Category:

Documents


0 download

TRANSCRIPT

Page 1: Baseline Report in accordance with Article 22(2) of the ... · baseline report for the proposed new state-of-the-art pharmaceutical development and manufacturing facility at a greenfield

GROUP

Baseline Report in accordance with Article 22(2) of

the Industrial Emissions Directive

Issue date: 19 December 2013

Celebrating 40 Years in Business

Jazz Pharmaceuticals Ireland Project Rock IE0311133-22-RP-0011, Issue: A

For

insp

ectio

n pur

pose

s only

.

Conse

nt of

copy

right

owne

r req

uired

for a

ny ot

her u

se.

EPA Export 30-12-2013:23:24:29

Page 2: Baseline Report in accordance with Article 22(2) of the ... · baseline report for the proposed new state-of-the-art pharmaceutical development and manufacturing facility at a greenfield

GROUP

162.TP.09, Issue 6, 14/01/2013 Formal Issue

Document Sign Off

Baseline Report

Jazz Pharmaceuticals Ireland Project Rock IE0311133-22-RP-0011, Issue A

File No: IE0311133.22.040

CURRENT ISSUE

Issue No: A Date: 19/12/2013 Reason for issue: For IEA Licence

Sign Off Originator Checker Reviewer Approver Customer Approval (if required)

Print Name Ciarán Reay Rory O’Dwyer Alistair Finlayson

Signature Authorised Electronically

Date

PREVIOUS ISSUES

Issue No

Date Originator Checker Reviewer Approver Customer Reason for issue

For

insp

ectio

n pur

pose

s only

.

Conse

nt of

copy

right

owne

r req

uired

for a

ny ot

her u

se.

EPA Export 30-12-2013:23:24:29

Page 3: Baseline Report in accordance with Article 22(2) of the ... · baseline report for the proposed new state-of-the-art pharmaceutical development and manufacturing facility at a greenfield

PA\GROUP

Jazz Pharmaceuticals Ireland Project Rock

IE0311133-22-RP-0011, Issue A 19/12/2013

IE0311133-22-RP-0011_A_01.DOC Page 3 of 19 Formal Issue

Contents

1 Introduction 4

1.1 Background 4

1.2 Requirement for Baseline Report 4

1.3 Scope of the Report 5

2 Land use 7

2.1 Current Use 7

2.2 Past Use 7

3 Soil & Groundwater Baseline Conditions 8

3.1 Soils 8

3.2 Bedrock Geology 11

3.3 Hydrogeology 12

4 Soil and Groundwater Contamination Hazards 16

4.1 Surface Water Runoff 16

4.2 Above Ground Tanks 16

4.3 Failure of Sanitary Wastewater System 17

4.4 Firewater 17

4.5 Chemical Spills 17

5 Conclusions 18

Attachment 1 19

Site Drawings 19

Attachment 2 20

Environmental Groundwater & Soil Report 20

Attachment 3 21

Geotechnical Interpretive Report 21

For

insp

ectio

n pur

pose

s only

.

Conse

nt of

copy

right

owne

r req

uired

for a

ny ot

her u

se.

EPA Export 30-12-2013:23:24:29

Page 4: Baseline Report in accordance with Article 22(2) of the ... · baseline report for the proposed new state-of-the-art pharmaceutical development and manufacturing facility at a greenfield

PA\GROUP

Jazz Pharmaceuticals Ireland Project Rock

IE0311133-22-RP-0011, Issue A 19/12/2013

IE0311133-22-RP-0011_A_01.DOC Page 4 of 19 Formal Issue

1 Introduction

This report has been prepared on behalf of Jazz Pharmaceuticals Ireland Limited (JPIL) as a baseline report for the proposed new state-of-the-art pharmaceutical development and manufacturing facility at a greenfield site in Monksland, Athlone, Co. Roscommon. The purpose of the report is to meet the requirements of Article 22(2) of the Industrial Emissions Directive (2010/75/EU). The scope of this report is further described in Section 1.3.

1.1 Background

The proposed development will develop, manufacture, and package drug products. The proposed development will initially employ 30 people Athlone region. The location of the proposed development is shown in Figure 1.1.

A planning application was submitted to Roscommon County Council in October 2013 (reference no. PD/13/328). A site plan and drainage layout drawings for the proposed facility are included in Attachment 1.

This report forms part of the IEA licence application.

1.2 Requirement for Baseline Report

1.2.1 European Legislation

The Industrial Emissions Directive (2010/75/EU) or ‘IED’ entered into force within the European Union on 6 January 2011. The IED brings together the Integrated Pollution Prevention and Control Directive (2008/1/EC), the Waste Incineration Directive (2000/76/EC) and five other directives in a single Directive on industrial emissions.

For industrial activities regulated by the IED, such as the proposed development, Article 22(2) of Chapter II of the IED states that:

“Where the activity involves the use, production or release of relevant hazardous substances and having regard to the possibility of soil and groundwater contamination at the site of the installation, the operator shall prepare and submit to the competent authority a baseline report before starting operation of an installation or before a permit for an installation is updated for the first time after 7 January 2013.

The baseline report shall contain the information necessary to determine the state of soil and groundwater contamination so as to make a quantified comparison with the state upon definitive cessation of activities provided for under paragraph 3.

The baseline report shall contain at least the following information:

(a) Information on the present use and, where available on past uses of the site;

(b) Where available, existing information on soil and groundwater measurements that reflect the state at the time the report is drawn up or, alternatively, new soil and groundwater measurements having regard to the possibility of soil and groundwater contamination by those hazardous substances to be used, produced or released by the installation concerned.

Where information produced pursuant to other national or Union law fulfils the requirements of this paragraph that information may be included in, or attached to, the submitted baseline report.

The Commission shall establish guidance on the content of the baseline report.”

1.2.2 Irish Legislation

Article 22(2), as part of Chapter II of the IED, was transposed into Irish national law on 23 April 2013 by the European Union (Industrial Emissions) Regulations 2013 (S.I. No. 138 of 2013) and resulting amendments to the Environmental Protection Agency Act 1992.

For

insp

ectio

n pur

pose

s only

.

Conse

nt of

copy

right

owne

r req

uired

for a

ny ot

her u

se.

EPA Export 30-12-2013:23:24:29

Page 5: Baseline Report in accordance with Article 22(2) of the ... · baseline report for the proposed new state-of-the-art pharmaceutical development and manufacturing facility at a greenfield

PA\GROUP

Jazz Pharmaceuticals Ireland Project Rock

IE0311133-22-RP-0011, Issue A 19/12/2013

IE0311133-22-RP-0011_A_01.DOC Page 5 of 19 Formal Issue

Section 86B of the Environmental Protection Agency Act 1992, as amended, states that:

“(1) Where an industrial emissions directive activity involves the use, production or release of relevant hazardous substances, and having regard to the possibility of soil and groundwater contamination at the site of an installation concerned, the Agency shall require an applicant under this Part for a licence or review of a licence or revised licence relating to the activity, including such a review by the Agency of its own volition, to furnish to the Agency a baseline report in accordance with regulations under section 89.”

“(2) In relation to an installation, a baseline report shall contain the information necessary to determine the state of contamination of soil and groundwater at the time the report is drawn up in order that a quantified comparison may be made to the state of the site upon the permanent cessation (including cessation by abandonment) of the industrial emissions directive activity concerned and the applicant in preparing the baseline report shall include any information prescribed in regulations under section 89.”

“(3) Notwithstanding the generality of subsection (2), a baseline report shall include at least the following information-

(a) The current use and, where available, the past use of the site,

(b) Any available information-

i. On soil or groundwater measurements that reflect the state of the site at the time that the baseline report is drawn up, or

ii. On new soil and groundwater measurements, having regard to the possibility of soil and groundwater contamination by the hazardous substances proposed to be used, produced or released by the installation concerned.

(4) Any information furnished to the Agency or to any other body under any enactment or rule of law or a law of the European Union, which complies with the requirements of subsection (2) or (3), may be furnished to the Agency in or with the baseline report.

(5) For the purposes of determining the information to be contained in a baseline report under this section the Agency shall have regard to, and shall for the purposes of subsection (2), make publicly available any guidance documents published by the Commission of the European Union in accordance with Article 22(2) of the Industrial Emissions Directive.”

1.3 Scope of the Report

This report compiles the soil and groundwater information from the Environmental Impact Statement (EIS), which was included in the planning application for the proposed development.

The current use and past use of the site are described in Section 2 of this report.

Available information on soil and groundwater measurements for the site are included in Section 3 of this report, with supporting data in Attachments 2 and 3. In accordance with Section 86(B)(4) of the EPA Act 1992, the information in Section 3 includes the results of soil and groundwater investigations completed during the course of the preparation of the EIS for the proposed development.

The possibility of soil and groundwater contamination by hazardous substances is addressed in Section 4 of this report, considering the potential sources of pollution on-site and other sources in the surrounding area.

It is noted that at the time of preparation of this report, the European Commission has not established guidance on the content of the baseline report as required by Article 22(2) of the IED. The scope of the report is therefore limited to the requirements of the legislation described at Section 1.2, as those requirements are currently understood.

For

insp

ectio

n pur

pose

s only

.

Conse

nt of

copy

right

owne

r req

uired

for a

ny ot

her u

se.

EPA Export 30-12-2013:23:24:29

Page 6: Baseline Report in accordance with Article 22(2) of the ... · baseline report for the proposed new state-of-the-art pharmaceutical development and manufacturing facility at a greenfield

PA\GROUP

Jazz Pharmaceuticals Ireland Project Rock

IE0311133-22-RP-0011, Issue A 19/12/2013

IE0311133-22-RP-0011_A_01.DOC Page 6 of 19 Formal Issue

Figure 1.1: Site Location

SSSIIITTTEEE LLLOOOCCCAAATTTIIIOOONNN

For

insp

ectio

n pur

pose

s only

.

Conse

nt of

copy

right

owne

r req

uired

for a

ny ot

her u

se.

EPA Export 30-12-2013:23:24:29

Page 7: Baseline Report in accordance with Article 22(2) of the ... · baseline report for the proposed new state-of-the-art pharmaceutical development and manufacturing facility at a greenfield

PA\GROUP

Jazz Pharmaceuticals Ireland Project Rock

IE0311133-22-RP-0011, Issue A 19/12/2013

IE0311133-22-RP-0011_A_01.DOC Page 7 of 19 Formal Issue

2 Land use

2.1 Current Use

The subject site is a large, industrially zoned and undeveloped site in Monksland, Athlone, Co. Roscommon. The site is located west of the already existing Monksland Industrial Estate. The L75841 local road runs along the northern boundary of the site. There are a number of individual dwellings on the northern side of the L75841 immediately to the north of the site and one dwelling neighbours the site at its north-western corner.

The local area is characterised by significant industrial and pharmaceutical developments of varying scale, which are present in Monksland Industrial Estate, as well as undeveloped land. Much of the land surrounding the Monksland Industrial Estate remains undeveloped. The M6 motorway runs along the eastern and southern boundary of the proposed site, but is separated from the proposed site by a large tract of green field land. Similarly, while the R362 Regional Road and the Westpoint Business Park bound the Monksland Industrial Estate to the north, a large area of undeveloped green field lands intervenes between the R362 and the development site.

The propose development site is located at the westernmost edge of Athlone Town, approximately 2.5 km from the centre of the Town. The wider area accommodates a number of large residential developments, including those to the northwest of the development site, those to the north of Westpoint Business Park and those to the east of the M6 motorway.

2.2 Past Use

The only known use of the site in the past is for agricultural purposes. There is no evidence of previous industrial activities in the past.

For

insp

ectio

n pur

pose

s only

.

Conse

nt of

copy

right

owne

r req

uired

for a

ny ot

her u

se.

EPA Export 30-12-2013:23:24:29

Page 8: Baseline Report in accordance with Article 22(2) of the ... · baseline report for the proposed new state-of-the-art pharmaceutical development and manufacturing facility at a greenfield

PA\GROUP

Jazz Pharmaceuticals Ireland Project Rock

IE0311133-22-RP-0011, Issue A 19/12/2013

IE0311133-22-RP-0011_A_01.DOC Page 8 of 19 Formal Issue

3 Soil & Groundwater Baseline Conditions

3.1 Soils

The soil is defined as a mixture of ‘Alluvium’ and ‘Limestone Sands and Gravel’ according to Geological Survey of Ireland (GSI) records, and the subsoil is classified by GSI as a mix of ‘Alluvium’ and ‘Glaciofluvial Sands and Gravel’. These soil and subsoil areas are shown in Figures 3.1 and 3.2.

Figure 3.1 Soil Classification Map (Red Line = Site Boundary)

Limestone Sands and Gravel

Alluvium Soil

Made Ground

For

insp

ectio

n pur

pose

s only

.

Conse

nt of

copy

right

owne

r req

uired

for a

ny ot

her u

se.

EPA Export 30-12-2013:23:24:29

Page 9: Baseline Report in accordance with Article 22(2) of the ... · baseline report for the proposed new state-of-the-art pharmaceutical development and manufacturing facility at a greenfield

PA\GROUP

Jazz Pharmaceuticals Ireland Project Rock

IE0311133-22-RP-0011, Issue A 19/12/2013

IE0311133-22-RP-0011_A_01.DOC Page 9 of 19 Formal Issue

Figure 3.2 Sub-Soil Maps (Red Line = Site Boundary)

Quaternary geological/database maps from the GSI online mapping indicate that the local quaternary deposits (sub soils) comprise glaciofluvial-derived sands and gravels, boulder clay and silt. Overburden thicknesses are known to vary to over 8m in depth.

Geotechnical investigations carried out at the site have revealed the ground conditions to comprise the following:

- Topsoil

- Peat

- Light to mid grey sandy silt / sandy clayey silt

- Grey and grey brown slightly clayey sandy gravel

- Limestone bedrock (Waulsortian, highly variable and subjected to significant karstification)

Topsoil or peat mantles the site and thickness varies from approximately 0.10m up to 0.85m. The topsoil is described as a sandy silt / clay with rootlets throughout. The peat is fibrous to amorphous in nature and locally contains gravels or cobbles.

Underlying the topsoil or peat is a mid-grey sandy silt or sandy clayey silt with horizons or lenses of fine to medium sand. These soils are deemed to represent slightly over-consolidated alluvial deposits and extend to depths of 5 to 7m bgl (below ground level). A thin layer of glacial soils were found to be sandwiched between the alluvial deposits and upper bedrock. The glacial soils consist of sandy clayey gravel and with medium to high cobble content.

Glaciofluvial Sands and Gravel

Alluvium Soil

Made Ground

For in

spec

tion p

urpo

ses o

nly.

Conse

nt of

copy

right

owne

r req

uired

for a

ny ot

her u

se.

EPA Export 30-12-2013:23:24:29

Page 10: Baseline Report in accordance with Article 22(2) of the ... · baseline report for the proposed new state-of-the-art pharmaceutical development and manufacturing facility at a greenfield

PA\GROUP

Jazz Pharmaceuticals Ireland Project Rock

IE0311133-22-RP-0011, Issue A 19/12/2013

IE0311133-22-RP-0011_A_01.DOC Page 10 of 19 Formal Issue

Soil Investigation

As part of the ground investigation by IGSL Ltd. for the proposed development, a soil sampling programme was undertaken in order to verify the condition of the land at the site, in terms of any existing contamination. A copy of the laboratory results is included in Attachment 2.

Samples were transferred into appropriate sampling containers at the site and stored in cooler boxes prior to dispatch to an accredited laboratory (Jones Environmental Laboratory). Each sample was analysed for the following suite of parameters:

- Total Poly Aromatic Hydrocarbons (PAH)

- Extractable Petroleum Hydrocarbons (EPH)

- Mineral Oil

- Gasoline Range Organics (GRO)

- Benzene, Toluene, Ethylbenzene, Xylene (BTEX)

- Pesticides

- Polychlorinated Biphenyls (PCB)

- Total Phenols

- Natural Moisture Content, Chloride, Sulphide, Chromium VI, heavy metals, pH, Total Cyanide, Free Cyanide, and Thiocyanate

The results are outlined in Table 3.1. Results have been compared to standards outlined in the EPA publication Towards Setting Environmental Quality Objectives for Soil Developing a Soil Protection Strategy for Ireland, A Discussion Document, EPA 2002. In the absence of standards in this document Dutch Target and Intervention Values from the Ministry of Housing, Spatial Planning and Environment, Directorate-General for Environmental Protection, 2000, were used.

Table 3.1: Results of Soil Analysis

Parameter Units Result from

TP15 Environmental Guideline Value

Environmental Guideline Source

pH pH Units 8.05 N/A1 N/A

Moisture Content 25.4 % N/A N/A

Chloride 17 mg/kg N/A N/A

Sulphide <10 mg/kg N/A N/A

Total Sulphate 303 mg/kg N/A N/A

Total Cyanide <0.5 mg/kg N/A N/A

Free Cyanide <0.5 mg/kg 20 Dutch Intervention Value

Tiocyanate <0.6 mg/kg 20 Dutch Intervention Value

Gasoline Range Organics (GRO)

<100 µg/kg N/A N/A

Mineral Oils <30 mg/kg 5,000 Dutch Intervention Value

Poly Aromatic Hydrocarbons (PAHs)

<0.6 mg/kg 40 Dutch Intervention Value

Extractable Petroleum Hydrocarbons (EPH)

42 mg/kg N/A N/A

BTEX2 <5 µg/kg 1

3 Dutch Intervention Value

1 N/A – Not Available

For

insp

ectio

n pur

pose

s only

.

Conse

nt of

copy

right

owne

r req

uired

for a

ny ot

her u

se.

EPA Export 30-12-2013:23:24:29

Page 11: Baseline Report in accordance with Article 22(2) of the ... · baseline report for the proposed new state-of-the-art pharmaceutical development and manufacturing facility at a greenfield

PA\GROUP

Jazz Pharmaceuticals Ireland Project Rock

IE0311133-22-RP-0011, Issue A 19/12/2013

IE0311133-22-RP-0011_A_01.DOC Page 11 of 19 Formal Issue

Parameter Units Result from

TP15 Environmental Guideline Value

Environmental Guideline Source

Total Phenols <0.15 mg/kg 40 Dutch Intervention Value

Polychlorinated Biphenyls (PCBs)

<35 µg/kg N/A N/A

Pesticides <1 µg/kg N/A N/A

Aluminium 3351 mg/kg 10,000 – 80,000 EPA Guideline Value

Arsenic 7 mg/kg 1 – 50 EPA Guideline Value

Boron 1.1 mg/kg 20 – 1000 EPA Guideline Value

Cadmium 0.8 mg/kg 0.1 – 1 EPA Guideline Value

Chromium 7.3 mg/kg 2 – 250 EPA Guideline Value

Chromium VI <0.3 mg/kg N/A N/A

Copper 13 mg/kg 2 – 100 EPA Guideline Value

Lead 7 mg/kg 2 – 80 EPA Guideline Value

Mercury <0.1 mg/kg 0.03 – 0.8 EPA Guideline Value

Nickel 19.9 mg/kg 0.5 – 100 EPA Guideline Value

Selenium <1 mg/kg 0.2 – 2 EPA Guideline Value

Sulphur 0.05 mg/kg 200 – 1,500 EPA Guideline Value

Zinc 38 mg/kg 10 – 200 EPA Guideline Value

3.2 Bedrock Geology

According to the GSI online database the bedrock geology below the study area comprises of Carboniferous Limestone of the Waulsortian Formation (WA). The Waulsortian Formation comprises of medium grey, massive, mostly unbedded fine grained limestones which are widespread across much of the country. Approximately 0.5km to the north of the site are the Visean limestones (VIS), which are the undifferentiated shelf limestones that occasionally crop out above the Waulsortian Limestones.

It is highlighted that Waulsortian Limestone is particularly susceptible to solution weathering (termed ‘karstification’) and manifestation of subsidence features. The GSI database does not show any karst features in the immediate vicinity of the site however the core drillholes carried out as part of the geotechnical investigation identified penetrative weathering which is attributed to karstification of the upper bedrock.

The cores drilled for the geotechnical investigation show that the upper bedrock or rock mass consists of pale grey, fine-grained Limestone, ranging from slightly weathered and strong to highly or completely weathered. Where the highly weathered material is present it has the structure of dense ‘clayey’ Gravel / Cobbles. The limestone exhibits signs of dolomitization and the weathering of the original rock is so pronounced that it has given rise to a heavily altered rock mass.

2 Benzene, Toluene, Ethylbenzene, Xylene

3 Lowest value for BTEX used, i.e. Benzene – 1mg/kg

For

insp

ectio

n pur

pose

s only

.

Conse

nt of

copy

right

owne

r req

uired

for a

ny ot

her u

se.

EPA Export 30-12-2013:23:24:29

Page 12: Baseline Report in accordance with Article 22(2) of the ... · baseline report for the proposed new state-of-the-art pharmaceutical development and manufacturing facility at a greenfield

PA\GROUP

Jazz Pharmaceuticals Ireland Project Rock

IE0311133-22-RP-0011, Issue A 19/12/2013

IE0311133-22-RP-0011_A_01.DOC Page 12 of 19 Formal Issue

3.3 Hydrogeology

As part of the ground investigation carried out by IGSL Ltd. groundwater samples were taken from the boreholes and analysed by Jones Environmental Laboratory, an accredited laboratory. Parameters monitored were those required for the IEA licence, which include the following:

- pH, temperature, conductivity

- Total ammonium (as N)

- Nitrates and Nitrites

- Orthophosphate, Phosphorus

- Dissolved Oxygen

- Metals

- Sulphate, Phosphate

- Total Organic Carbon

- Fluoride

- Phenol

- Faecal Coliforms, Total Coliforms

Groundwater was sampled at two boreholes (EMBH1 and EMBH2), one to the north of the site and one to the south. It is understood that groundwater flow runs from north to south towards the Cross River, therefore the boreholes represent the upstream and downstream conditions of the proposed development site. The results are outlined in Table 3.2. Results have been compared to standards outlined in the European Communities Environmental Objectives (Groundwater) Regulations, 2010 (S.I. No. 9 of 2010), and where standards were not available in the aforementioned regulations standards were referenced from Towards Setting Guideline Values for the Protection of Groundwater in Ireland Interim Report, EPA 2003 (EPA IGV). A copy of the groundwater laboratory results is included in Attachment 2.

Table 3.2: Results of Groundwater Analysis

Parameter Units EMBH1

(North of Site)

EMBH2 (South of

Site)

Environmental Guideline Value

Environmental Guideline

Source

Dissolved Oxygen mg/l 2 3 No Abnormal

Change EPA IGV

Conductivity µS/cm 1116 747 800 – 1875 S.I. 9 of 2010

Total Alkalinity (as CaCO3)

mg/l 424 360 No Abnormal

Change EPA IGV

pH pH Units 7.45 7.36 6.5 – 9.5 EPA IGV

Total Coliforms CFU/100ml 110 2 0 EPA IGV

Faecal Coliforms CFU/100ml <1 <1 0 EPA IGV

Total Organic Carbon mg/l <2 19 No Abnormal

Change EPA IGV

Total Solids mg/l 729 467 1000 EPA IGV

Fluoride mg/l <0.3 <0.3 1 EPA IGV

Sulphate mg/l 100.2 33.8 187.5 S.I. 9 of 2010

Chloride mg/l 77.1 23.7 24 – 187.5 S.I. 9 of 2010

Nitrate (as NO3) mg/l <0.2 10.9 37.5 S.I. 9 of 2010

For

insp

ectio

n pur

pose

s only

.

Conse

nt of

copy

right

owne

r req

uired

for a

ny ot

her u

se.

EPA Export 30-12-2013:23:24:29

Page 13: Baseline Report in accordance with Article 22(2) of the ... · baseline report for the proposed new state-of-the-art pharmaceutical development and manufacturing facility at a greenfield

PA\GROUP

Jazz Pharmaceuticals Ireland Project Rock

IE0311133-22-RP-0011, Issue A 19/12/2013

IE0311133-22-RP-0011_A_01.DOC Page 13 of 19 Formal Issue

Parameter Units EMBH1

(North of Site)

EMBH2 (South of

Site)

Environmental Guideline Value

Environmental Guideline

Source

Nitrite (as NO2) mg/l <0.02 1.54 0.375 S.I. 9 of 2010

Nitrate (as N) mg/l <0.05 2.45 N/A N/A

Nitrite (as N) mg/l <0.006 0.47 N/A N/A

Orthophosphate (as PO4)

mg/l 0.18 <0.06 N/A N/A

Orthophosphate (as P)

mg/l 0.06 <0.03 N/A N/A

Total Oxidised Nitrogen (as N)

mg/l <0.2 2.9 No Abnormal

Change EPA IGV

Total Ammonia (as N) mg/l 0.07 0.05 0.065 – 0.175 S.I. 9 of 2010

Extractable Petroleum Hydrocarbons (C8-

C40) µg/l <10 <10 N/A N/A

Gasoline Range Organics (>C4-C8)

µg/l <10 <10 N/A N/A

Gasoline Range Organics (>C8-C12)

µg/l <10 <10 N/A N/A

Gasoline Range Organics (>C4-C12)

µg/l <10 <10 N/A N/A

Phenol mg/l <0.01 <0.01 0.0005 EPA IGV

Aluminium µg/l <20 <20 150 S.I. 9 of 2010

Arsenic µg/l 7.7 3.0 7.5 S.I. 9 of 2010

Barium µg/l 85 114 N/A N/A

Boron µg/l 23 <12 750 S.I. 9 of 2010

Cadmium µg/l <0.5 <0.5 3.75 S.I. 9 of 2010

Calcium mg/l 121.5 108 200 EPA IGV

Chromium µg/l <1.5 <1.5 37.5 S.I. 9 of 2010

Copper µg/l <7 <7 1500 S.I. 9 of 2010

Iron µg/l 32 <20 200 EPA IGV

Lead µg/l <5 <5 18.75 S.I. 9 of 2010

Magnesium mg/l 21 23.8 50 EPA IGV

Manganese µg/l 1866 256 50 EPA IGV

Mercury µg/l <1 <1 0.75 S.I. 9 of 2010

Nickel µg/l 25 4 15 S.I. 9 of 2010

Phosphorus µg/l 14 11 N/A N/A

Potassium mg/l 5.7 0.9 5 EPA IGV

Selenium µg/l <3 <3 N/A N/A

Silver µg/l <5 <5 N/A N/A

Sodium mg/l 89.3 12.9 150 S.I. 9 of 2010

For

insp

ectio

n pur

pose

s only

.

Conse

nt of

copy

right

owne

r req

uired

for a

ny ot

her u

se.

EPA Export 30-12-2013:23:24:29

Page 14: Baseline Report in accordance with Article 22(2) of the ... · baseline report for the proposed new state-of-the-art pharmaceutical development and manufacturing facility at a greenfield

PA\GROUP

Jazz Pharmaceuticals Ireland Project Rock

IE0311133-22-RP-0011, Issue A 19/12/2013

IE0311133-22-RP-0011_A_01.DOC Page 14 of 19 Formal Issue

Parameter Units EMBH1

(North of Site)

EMBH2 (South of

Site)

Environmental Guideline Value

Environmental Guideline

Source

Zinc µg/l <3 <3 100 EPA IGV

Cyanide mg/l <0.01 <0.01 0.0375 S.I. 9 of 2010

The groundwater at the site was found to be in good quality with the majority of groundwater quality parameter value below or within acceptable ranges of the relevant quality standards. There are some results which are higher than applicable standards. Total coliforms show values above the standards for both borehole locations. This may be due to the fact that there has been, up until recently, bloodstock grazing in these areas. Other exceedences such as Orthophosphate, Arsenic, and Potassium are only slightly exceeded and do not represent poor groundwater quality. Manganese values found at the site are significantly higher than the relevant standard, which can be a common occurrence. Elevated manganese levels do not pose a health risk however.

The WaterMaps online mapping system (www.wfdireland.ie) was consulted in order to determine the status of the groundwater body in the vicinity of the proposed development site. The proposed development site presides over the Athlonewest_1 water body (IE_SH_G_018) for the most part. A small section of the site along its western boundary presides over the Athlone urban water body (IE_SH_G_017). Both groundwater bodies are of Good status with an overall objective to Protect.

Groundwater Vulnerability

Information from the GSI’s online database for Roscommon indicates the following:

- The site has an aquifer classification of LI, indicating that the site is underlain by a “locally important” bedrock aquifer, which is generally moderately productive in local zones.

- The Groundwater Protection Zone within which the site falls is classed as LI/H, indicating that the site is a “locally important aquifer of high vulnerability” (H). This means that whilst the aquifer is only of local importance, it is however considered highly vulnerable to potential pollution due to a reduced overburden cover.

- There are no Source Protection Areas on, or in the immediate vicinity of, the site, according to the GSI national database. A Source Protection Area is a land area that contributes groundwater to a borehole or spring.

These aquifer and aquifer vulnerability areas are shown in Figures 3.3 and 3.4 obtained from Geological Survey of Ireland (GSI) online records.

For

insp

ectio

n pur

pose

s only

.

Conse

nt of

copy

right

owne

r req

uired

for a

ny ot

her u

se.

EPA Export 30-12-2013:23:24:29

Page 15: Baseline Report in accordance with Article 22(2) of the ... · baseline report for the proposed new state-of-the-art pharmaceutical development and manufacturing facility at a greenfield

PA\GROUP

Jazz Pharmaceuticals Ireland Project Rock

IE0311133-22-RP-0011, Issue A 19/12/2013

IE0311133-22-RP-0011_A_01.DOC Page 15 of 19 Formal Issue

Figure 3.3 Aquifer Classification Map (Red line = Site Boundary)

Figure 3.4 Aquifer Vulnerability Classification Map (White Line = Site Boundary)

LI – Locally important Aquifer Bedrock which is moderately productive only in local zones

LI/H -Locally important Aquifer of High Vulnerability

For

insp

ectio

n pur

pose

s only

.

Conse

nt of

copy

right

owne

r req

uired

for a

ny ot

her u

se.

EPA Export 30-12-2013:23:24:29

Page 16: Baseline Report in accordance with Article 22(2) of the ... · baseline report for the proposed new state-of-the-art pharmaceutical development and manufacturing facility at a greenfield

PA\GROUP

Jazz Pharmaceuticals Ireland Project Rock

IE0311133-22-RP-0011, Issue A 19/12/2013

IE0311133-22-RP-0011_A_01.DOC Page 16 of 19 Formal Issue

4 Soil and Groundwater Contamination Hazards

The facility has been designed to ensure the protection of soil and groundwater. All materials handling will be undertaken indoors and external areas of hardstanding are designed to eliminate a direct pathway for any hazardous substances to pollute the underlying ground. The facility will be operated under an Environmental Management System which will ensure adequate procedures and work practices are in place to prevent pollution of the environment.

In addition, the solvent that will be used in the production process for dissolution and mixing of raw materials is water. There will be no solvent waste or emissions from the proposed facility. The proposed development will not use or produce genetically modified organisms (GMOs), or particularly hazardous materials in the manufacturing processes, e.g. substances with Risk Phrases such as R45 (May cause cancer), R46 (May cause inheritable genetic damage), R50 (Very toxic to aquatic organisms), R58 (May cause long-term adverse effects in the environment), R61 (May cause harm to the unborn child) and R63 (Possible risk of harm to the unborn child, which are high risk.

Therefore, considering the source-pathway-receptor approach, it is concluded the potential for contamination of soil and groundwater by hazardous substances is limited to the following potential sources which are reviewed in further detail below.

- Contamination of surface water runoff (e.g. by spill etc.) leading to subsequent contamination of soil/groundwater;

- Loss of containment from above ground tanks;

- Failure of sanitary wastewater treatment system;

- Fire on-site resulting in the generation of contaminated firewater;

- Chemical spills and leaks on areas of hardstanding draining to ground.

4.1 Surface Water Runoff

It is proposed to construct a surface water drainage system for the site. This will collect runoff from roofs, roads and paved areas. The surface water drainage system carries the storm water to an attenuation pond located south of the proposed buildings.

Should the stormwater comply with the discharge conditions of the IEA Licence, it will be released to the existing drainage ditch and on to the Cross River. All road and paving gullies will be trapped. No flood waters will be allowed to leave the site up to and including a 1:100 year event in accordance with the Greater Dublin Strategic Drainage Study. A hydrobrake flow control device will limit the flow of stormwater to the existing ditch and ultimately to the Cross River. Furthermore a class 1 bypass petrol interceptor will be installed on the surface water drainage system.

In the event that discharge from the stormwater attenuation pond is outside of the licensed parameters for discharge, a shut-off valve will be provided on the outlet of the surface water attenuation pond in order for it to be isolated. The non-compliant stormwater may be sent to the nearby Monksland WWTP for treatment or held in the attenuation pond for interim storage pending a decision on its fate.

4.2 Above Ground Tanks

The following tanks will be installed above ground:

- 1 no. emergency generator with associated ‘belly’ tank (Diesel Storage)

- 1 no. process effluent balancing tank

- 2 no. water tank for potable and firewater supply

The emergency generator will contain a small volume of diesel for running the back-up generator. It will be located away from drains and watercourses and held in double contained tank.

For

insp

ectio

n pur

pose

s only

.

Conse

nt of

copy

right

owne

r req

uired

for a

ny ot

her u

se.

EPA Export 30-12-2013:23:24:29

Page 17: Baseline Report in accordance with Article 22(2) of the ... · baseline report for the proposed new state-of-the-art pharmaceutical development and manufacturing facility at a greenfield

PA\GROUP

Jazz Pharmaceuticals Ireland Project Rock

IE0311133-22-RP-0011, Issue A 19/12/2013

IE0311133-22-RP-0011_A_01.DOC Page 17 of 19 Formal Issue

Process drainage is primarily generated during cleaning of the process equipment. A separate underground piped drainage system will be installed to transport process waste to the onsite waste water balancing system. The proposed waste water balancing system will carry out balancing in terms of hydraulic flow and pH. Effluents from the waste water balancing system will be discharged to the onsite foul drainage system and onward to the proposed foul pumping station. The pump station will then pump the effluent to a proposed new sewer adjacent to the L75841 and then on to the existing Monksland WWTP for treatment.

The water tanks for potable and firewater supply will be used solely for the storage of water and will not store hazardous substances.

4.3 Failure of Sanitary Wastewater System

The sanitary or domestic effluent arising at the facility will be generated by kitchen facilities, sinks, toilets etc. It is proposed to construct a new separate gravity foul drainage system on the site. The domestic foul effluent will be collected by an underground gravity sewer and carried to a new onsite pump station. The pump station will then pump the effluent to a proposed new gravity sewer adjacent to the L75841 which will then fall by gravity to the existing Monksland WWTP for disposal.

The following mitigation measures will be adopted in order to ensure that the provision of foul sewerage facilities will not adversely affect the water environment;

- All foul sewers will be pressure tested and surveyed prior to connection to the existing mains foul sewer.

- Roscommon County Council approval will be sought and obtained prior to the connection of sewerage to the Monksland WWTP.

- There are no further remedial or reductive measures as it is expected that sewerage for the development will be adequately designed to cater for the proposed use that there are adequate mains sewer capacities and sewage treatment capacity will be provided.

Subject to frequent inspection and regular scheduled maintenance, there is limited potential for contamination arising from the sanitary effluent treatment plant and foul water drainage system on-site.

4.4 Firewater

It has been determined through a firewater retention risk assessment that a firewater retention facility is not required for the proposed development. However, the surface water attenuation pond will also act as the site firewater retention facility in the unlikely event of a fire. In this scenario a shut-off valve will be provided on the outlet of the surface water attenuation pond in order for it to be isolated. This will ensure that any potential contaminated firewater run-off will not enter the drainage ditch, and ultimately the Cross River system.

4.5 Chemical Spills

Detailed procedures and training will be established for the use, handling and storage of all chemicals on-site to ensure that the risk of spills is minimised. Chemicals will be stored in designated, labelled areas and bunding will be provided where required. Bunding will be designed in accordance with EPA requirements. Preventative maintenance and routine monitoring of tanks and equipment will minimise the likelihood of leaks/spills occurring and ensure that any leaks are quickly detected and controlled. All bunds and external tanks will be subject to regular inspection and maintenance.

For

insp

ectio

n pur

pose

s only

.

Conse

nt of

copy

right

owne

r req

uired

for a

ny ot

her u

se.

EPA Export 30-12-2013:23:24:29

Page 18: Baseline Report in accordance with Article 22(2) of the ... · baseline report for the proposed new state-of-the-art pharmaceutical development and manufacturing facility at a greenfield

PA\GROUP

Jazz Pharmaceuticals Ireland Project Rock

IE0311133-22-RP-0011, Issue A 19/12/2013

IE0311133-22-RP-0011_A_01.DOC Page 18 of 19 Formal Issue

5 Conclusions

This report includes the results of soil and groundwater monitoring for the proposed site in advance of the planned construction of a new state-of-the-art pharmaceutical development and manufacturing facility. These results describe the baseline conditions at the existing greenfield site, as of September 2013.

There is no indication of significant pollution of soil at the current site, consistent with the current land use and historic land use as understood. The groundwater at the site was found to be in good quality with the majority of groundwater quality parameter value below or within acceptable ranges of the relevant quality standards. There are some results which are higher than applicable standards. Total coliforms show values above the standards for both borehole locations. This may be due to the fact that there has been, up until recently, bloodstock grazing in these areas. Other exceedences such as Orthophosphate, Arsenic, and Potassium are only slightly exceeded and do not represent poor groundwater quality. Manganese values found at the site are significantly higher than the relevant standard, which can be a common occurrence. Elevated manganese levels do not pose a health risk however.

The proposed development has been designed to ensure the protection of soil and groundwater. All materials handling will be undertaken indoors and accordingly there is a relatively low risk of soil/groundwater pollution arising during normal operations. The main hazards for contamination of soil and groundwater comprise:

- Spills resulting in the contamination of surface water or soil;

- Loss of containment from storage tanks or the sanitary system;

- Contaminated runoff in the event of fire.

As described in Section 4, the design of the facility coupled with robust environmental management practices on-site will ensure that the risk of the above unplanned events will be minimised.

In the event of cessation of site activities, the site will be closed in accordance with the Closure Plan which has been submitted as supporting information with IEA licence application (PM Document No. IE0311133-22-RP-0008, Issue A). Furthermore an Environmental Liability Risk Assessment (ELRA) (PM Document No. IE0311133-22-RP-0007, Issue A) has been carried out and included in the IEA application. This ELRA will be updated as required throughout the operational lifetime of the proposed development. This will ensure that any potentially polluting substances are removed from the site in a controlled manner and that there will be no significant residual pollution of soil or groundwater.

For

insp

ectio

n pur

pose

s only

.

Conse

nt of

copy

right

owne

r req

uired

for a

ny ot

her u

se.

EPA Export 30-12-2013:23:24:29