site condition reportin september 2016, alexion was granted permission for a three-storey biologics...

kCExioN· PA\ GROUP

Site Condition Report

Issue date: 29 Nov 2018

Alexion Pharma International Operations UC AAMF Level 2 Cell Culture IE0312344-22-RP-0001, 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 04-12-2018:03:57:14

PM GROUP

Formal Issue

Document Sign Off

Site Condition Report

Alexion Pharma International Operations UC AAMF Level 2 Cell Culture IE0312344-22-RP-0001, Issue A

File No:IE0312344.22.040

CURRENT ISSUE

Issue No: A Date: 29/11/2018 Reason for issue: For IE Licence Application

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

Print Name Darragh O’Brien AINE.MONAGHAN STEPHEN.BURKE

Signature Authorised Electronically

Date 29/11/2018 29/11/2018 29/11/2018

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 04-12-2018:03:57:14

PM GROUP

Alexion Pharma International Operations UC AAMF Level 2 Cell Culture

IE0312344-22-RP-0001, Issue A 29 Nov 2018

IE0312344-22-RP-0001_A_02.DOCX of 28 Formal Issue

Contents

1 Introduction 4

1.1 Site Location and Description 4

2 Development and Operational History of the Site 7

3 Site Environmental Conditions 8

3.1 Soils 8

3.2 Subsoils 9

3.3 Bedrock 10

3.4 Hydrogeology 16

3.5 Surface Water 20

3.6 Air Quality 25

3.7 Noise 26

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 04-12-2018:03:57:14

PM GROUP


IE0312344-22-RP-0001, Issue A 29 Nov 2018


1 Introduction

This Site Condition Report has been prepared for Alexion Pharma International Operations UC (referred to hereinafter as Alexion) as part of an application for an Environmental Protection Agency (EPA) Industrial Emissions (IE) licence at its facility at Monksland Industrial Estate, Athlone, Co. Roscommon. The IED Licence will allow Alexion to carry out the following activity which is listed in the amended First Schedule of the EPA Act 1992, as amended;

5.16: The production of pharmaceutical products including intermediates (production means the production on an industrial scale by chemical or biological processing).

Alexion is a global biopharmaceutical company focused on serving patients with rare and ultra-rare disorders through the innovation, development and commercialisation of life-transforming therapeutic products. Headquartered in Boston, Massachusetts, USA, today Alexion has more than 2,500 employees worldwide, including operations in more than 30 countries in Europe, to serve patients with severe and life-threatening rare diseases.

The Alexion Athlone site consists of an Administration and Laboratory Building, a Sterile Fill Finish Building and a Central Utilities Building (CUB). In September 2016, Alexion was granted permission for a three-storey Biologics Manufacturing Building, as well as other extensions and amendments to the site (Planning Ref No. 16287). In April 2017, Alexion was granted permission (Planning Ref No. 1775) for alterations and additions to a previously approved development reference number 16287.

The Biologics Manufacturing Building has since been constructed; however Level 2 had been left fallow under the original project. A project is currently underway to fitout Level 2 to a clinical scale cell culture area, to accommodate the manufacture of biologically-derived drug substances, up to 2,000L bioreactor scale (project hereinafter referred to as Level 2 Cell Culture (L2CC)). It is L2CC process which has triggered the requirement for an IE licence from the EPA as the site will fall under Activity Class 5.16 as described above.

This Site Condition Report has been prepared to comply with Section 4.8 of the online EPA Licence application system, and has been prepared in accordance with the EPA’s Licence Application Form Guidance – Industrial Emissions (IE), Integrated Pollution Control (IPC) and Waste, Issue 1 (2017).

1.1 Site Location and Description

The Alexion site is located approximately 2.5 km west of Athlone town centre (See Figure 1.1) and covers an area of approximately 2.4 hectares (6 acres).

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 04-12-2018:03:57:14

PM GROUP


IE0312344-22-RP-0001, Issue A 29 Nov 2018


Figure 1.1: Alexion Site Boundary and Location (Alexion Site outlined in red; Source: Google Earth; Annotated by PM Group)

Lands in the immediate vicinity of the site are predominantly industrial (See Figure 1.2). A facility operated by Arran Chemicals bounds the site to the north and another facility operated by Alkermes Pharma Ireland Ltd (Alkermes) bounds the site to the north, east and west. To the south of the site is an area of undeveloped land, beyond which is the M6/N6 motorway and the Dublin to Galway railway line. The wider area is characterised by a mixture of industrial, commercial and residential development. To the South of the site is a small wetland area. Alexion Athlone operates as a fully independent site.

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 04-12-2018:03:57:14

I!:! C..P ..... m-· • LMu9 lCUWJI o- •""""'""*" --- -locmC... Pa'lllughl.nllll*Y o~a~ ....... o~u.. - TraMNNI~ - Putlk....._

-M·~ o~A--- - ~N--i PMwyAl)iM O NHA..,..... --- ~Ura"'* D s...gic~ ~lrdmlMo~Fad ~ .x._ ....

PM GROUP


IE0312344-22-RP-0001, Issue A 29 Nov 2018


Figure 1.2: Land Use Zoning Objectives (Alexion Site Highlighted in red; Source: Roscommon County Council Development Plan 2014-2020; Annotated by PM Group)

There are 10 SACs and 3 SPAs located within 15 km of the proposed development site, these are outlined below in Section 3.5.1 of this report.

The Alexion site holds a Trade Effluent Discharge Licence issued by Irish Water (IW-DTS-788194-02) and managed by Irish Water and Roscommon County Council. The sterile filling process does not involve any solvents and general quantities stored on site are very low. The existing Sterile Fill Finish Building is supported by an adjoining single storey Warehouse, an Administration and Laboratory Building as well as a Central Utilities Building. In general terms, there is only 1 primary activity carried out at the existing Alexion Athlone site, this involves the sterile filling of vials with drug substance manufactured in bulk at another location. The filling process is largely automated and once filled, the sterile vials are palletised and sent off site for final packaging. The existing facility commenced the manufacturing of commercial batches in May 2016.

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 04-12-2018:03:57:14

PM GROUP


IE0312344-22-RP-0001, Issue A 29 Nov 2018


2 Development and Operational History of the Site

Originally the site belonged to Elan Corporation who set up its manufacturing operation in the Monksland Industrial Park in 1978. In September 2011 and on completion of a merger transaction, the former Elan Corporation Athlone site was named as Alkermes Pharma Ireland Limited (APIL) a subsidiary of Alkermes plc. In February 2014, Alexion Pharma International Trading (APIT) acquired part of the former Alkermes site.

The potential presence of contamination due to historical leaks from EPA licenced facilities up gradient of the Alexion site was identified during desk top assessment and scoping as part of the Environmental Impact Statement (2016). A detailed environmental assessment of the extent of soil and groundwater contamination in the development area was undertaken (by AWN consultants and Geosyntec Consultants Ltd.) to determine the extent of a contaminated plume emanating from a historical up-gradient source.

A full list of planning permissions granted since Alexion took over ownership of the site is included in Attachment-6-1-Stakeholder-Engagement of this licence application form.

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 04-12-2018:03:57:14

• "'"e.f°$11'1C!s-~'-t .. ,..eund,,.d9'•·e

• W¥S.ed-M1,,.e.i:~1r,.e1.C...,t":i

• 11 ICt • Mtdt 9rowf'td

iAC • lACiJl!J' "• t'J'C)e so, .J

Scree. Scttt

• Bm"'s.:-r. .5 .. .,~ s>e•r, po,otfyd .. , ned fl'\"'f"t ,.,, !i.7 ffl c e-1"1" "s~r.. S"'• w ro<~, PH~ f'<OI"",. P'l•~,m,...,.. tor"':Oe(•t ~ ... .,bHC

• e.,;o,. e •• ,..,~., • Ft!-rPt. r't" pee~

• ~,>, - Ruocl Peo, • c ... ~ · Ci..":O\e, c.,"TA""'t p,e:,, .A MlN-A ,e ,.,,,,.,., • A .,1,1R1. • .:. • .,..,rl)

ef"'! '°'?O.M ,,.~;• poo,!yett f'll~d Pl.a fli'ybu c Br- "'~DP~ - P'et:-1 OOOf') era f"O'Q"" .. ,e~e ~• "Y b., c

Alexion Site

A.""'nS,•.:.S.,.a,o.,,,at dr•ntOt'f!f"ere. Ut.ny o<<I c

• A-ri nr,-.//. O•.p ~• C!"• nee r, ,_.,. v. r", ecoc

• Affl nOO-'-' f't'tt PoO'f','4'• !"<td ,.•, f'll:,•Cd<

PM GROUP


IE0312344-22-RP-0001, Issue A 29 Nov 2018


3 Site Environmental Conditions

3.1 Soils

The soil distribution is shown in Figure 3.1. The soils are described on the Soil association Map of Ireland compiled by Teagasc

1, as primarily BminSW- Shallow well-drained mineral (Mainly basic)

with AlluvMIN- Alluvial (mineral) located just to the South of the site.

Figure 3.1: Teagasc Map of Soils Underlying and Surrounding the Alexion Site

1 https://dcenr.maps.arcgis.com/apps/MapSeries/index.html?appid=a30af518e87a4c0ab2fbde2aaac3c228

(Last Accessed November 2018)

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 04-12-2018:03:57:14

https://dcenr.maps.arcgis.com/apps/MapSeries/index.html?appid=a30af518e87a4c0ab2fbde2aaac3c228

Cut Cu, ove: ra sec peat BasEslc Es ers compr sec of grave s of bas c react on Gcs Grave s cer ved 'rom L mes:ones • •

Alexion Site

t

PM GROUP


IE0312344-22-RP-0001, Issue A 29 Nov 2018


3.2 Subsoils

The subsoil distribution is shown on Figure 3.2. The soils are described on the Quaternary Sediment maps of Ireland, compiled by Geological Survey Ireland (GSI), as GLs- Gravels derived from Limestones.

Figure 3.2: Subsoils Surrounding the Alexion Site

3.2.1 Soil Investigation

As part of a desk top study carried out by AWN (Technical note dated May 1st 2016) six

representatives soil samples (leachate analysis) were analysed for Volatile Organic Compound (VOC) suite, no exceedances of any VOC above detection limit were noted. Waste Acceptance Criteria (WAC) analysis was undertaken in 14 representative soil samples and confirmed that the soil is suitable for inert disposal.

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 04-12-2018:03:57:14

D Visean rnestones und uerent ated

[] Wau sort an mestones

Alexion Site

• \

N t

PM GROUP


IE0312344-22-RP-0001, Issue A 29 Nov 2018


3.3 Bedrock

3.3.1 Bedrock Geology

Figure 3.3 which has been taken from the Geological Survey of Ireland website, shows that the site is underlain by a bedrock consisting of Waulsortian Limestones with areas of Visean Limestone (undifferentiated) located to the north. Waulsortian Limestones are a Massive unbedded lime-mudstone. These are pale grey in colour and typically 300-500m thick. These formed during the Carboniferous system and Dinantian series in the lower visean stage. Drilling within the Alexion site boundary indicates that the bedrock is highly weathered from 0.9 – 5.8 m (reported as angular gravel/cobbles) below ground level (m bgl) with more competent rock generally encountered after 5 m bgl. The limestone is characterised by a large number of open sub-horizontal fractures with a dip of 1° – 5°. The fractures are commonly clay or gravel-filled and the observed frequency of fracture zones decreases with depth.

Figure 3.3: Bedrock Geology of the Site and Surrounding Area

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 04-12-2018:03:57:14

GOLDEN IS LANO

(Kllm1 ne)

COLDt'.N ISLAND

CRANNAGH IIORE

BUN AR BIIA

KILNA ANA H

Athlone

River Shannon Callows

CRANNAGH

CRAN CAM

CRANNACH eirc Alexion Site

• -, CUILLEEN

11 ...

PM GROUP


IE0312344-22-RP-0001, Issue A 29 Nov 2018


3.3.2 Geological Heritage

Figure 3.4 which has been taken from the Geological Survey of Ireland website, shows that a Geological heritage site, the River Shannon Callows, is located 2 km to the South-East of the Alexion site. The River Shannon Callows is a long, flat site which includes the Shannon river floodplain. The site has extensive areas of callow, or seasonally flooded, semi-natural, lowland wet grassland, along both sides of the river.

Figure 3.4: Geological Heritage Sites in the Surrounding Area

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 04-12-2018:03:57:14

IIUNNA

t

l~OlllURE 1, ... t.lOYNURE

11\ 's1u Supe,.rc e So ut on Feeture.

(: s.,a o.-, 1-'o e

-,..r1ough

KILUOCOLUOCK

KHLT'I'

CRANNAOH IIORE IC() Bore hoe

Q u.e Ory Ila t>;

e Enc; o,ed :>e p<en on

"O Sp, "9

DEL Rf A

CRAN CAI.I

KILHAIIANAGH TADUFf W£S1

CRAHNAOH

EEN DOOVOGE CREACH

Alexion Site

BELLAUOH

llELLANAUIILLIA

a.rao1n.vnuffl.a

PM GROUP


IE0312344-22-RP-0001, Issue A 29 Nov 2018


3.3.3 Karst Features

Figure 3.5 which has been taken from the Geological Survey of Ireland website, shows that there are 2 no. karstic features located in the vicinity of the Alexion site. This includes an Enclosed Depression 3 km to the South and a Spring 3.5 km to the South-West.

Figure 3.5: Karstic Features nearby to the Alexion Site.

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 04-12-2018:03:57:14

Alexion Site

I Castlesmapson Quarry

N f

PM GROUP


IE0312344-22-RP-0001, Issue A 29 Nov 2018


3.3.4 Economic Geology

Figure 3.6 which has been taken from the Geological Survey of Ireland website, shows that the Castlesampson Quarry is located 7.8 km to the west of the Alexion site. This is an active limestone quarry.

Figure 3.6: Economic Geology Near the Alexion Site

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 04-12-2018:03:57:14

Landslide Event

···""j •

B.illykeet.in

Athlone

Alexion Site

Bell,m.imulh.i l •

~

N t

PM GROUP


IE0312344-22-RP-0001, Issue A 29 Nov 2018


3.3.5 Geo-Hazards

There is only 1 no. Geo-Hazard event recorded which occurred in the vicinity of the Alexion Site. This was a landslide which occurred on the 1

st January 2013 at Tullywood Bog, 10 km to the East

of the Alexion site (See Figure 3.7), which has been taken from the Geological Survey of Ireland website.

Figure 3.7: GeoHazard Events Which Occurred Near the Alexion Site.

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 04-12-2018:03:57:14

1 o/o - 5%

5% - 10%

10% - 20%

> 20%

< 1 o/o

•

Alexion Site

Between one and five per cent of the homes in this 10km grid square are estimated to be above the Reference Level

Radon Map ~ N t

PM GROUP


IE0312344-22-RP-0001, Issue A 29 Nov 2018


3.3.6 Radon

Figure 3.8 which has been taken from the EPA Radon Map2 shows that between one and five per

cent of homes in the same 10 km grid as the Alexion site are estimated to be above the Reference level of 200 bequerel per cubic metre (Bq/m

3) of radon.

Figure 3.8: Radon Levels in the Area Surrounding the Alexion Site

2 http://www.epa.ie/radiation/radonmap/ (Last Accessed November 2018)

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 04-12-2018:03:57:14

http://www.epa.ie/radiation/radonmap/

Alexion Site

• • •

At

Rice - ~eg one ly Im portent Aquifer - Kerst r ed (condu :)

LI - Locelly lmportent AGu 'er - Bedrocc which s Moderete y :>roduct,ve only n _oce Zones

Locelly mportent Greve( Aquifer

Reg one y Important Grave Aqu 'er ~---

'<;

N f

PM GROUP


IE0312344-22-RP-0001, Issue A 29 Nov 2018


3.4 Hydrogeology

3.4.1 Aquifer Classification

Aquifers are underground layers of rock which contain water and which are capable of yielding it to surface waters such as streams or rivers and groundwater-fed ecosystems. The GSI has developed a classification system for the aquifers based on the value of the resource and the hydrogeological characteristics. The bedrock beneath the site is characterised by the GSI as Li- Locally Important Aquifer- Bedrock which is Moderately Productive only in Local Zones. The Aquifer classification is seen on Figure 3.9 below which has been taken from the Geological Survey of Ireland website.

Figure 3.9: Aquifer Classification in the area Surrounding the Alexion Site

3.4.2 Groundwater Flow Direction

The natural groundwater flow direction is from north to south with an approximate elevation range of 39 – 40m above Ordnance Datum (m AOD) across the Alexion site, with a gentle gradient of 0.003 m/m.

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 04-12-2018:03:57:14

• H-Hgh

• M. Modera:e

• L-Lo,.

• X • 0oe< a: o, n~ar s~r'ace o< ..:."':

E- E.t<treme

t N ..

Alexion Site

PM GROUP


IE0312344-22-RP-0001, Issue A 29 Nov 2018


3.4.3 Groundwater Vulnerability

Vulnerability is defined by the GSI as the intrinsic geological and hydrogeological characteristics that determine the ease with which groundwater may be contaminated by human activities. Vulnerability categories range from Extreme (E) to High (H) to Moderate (M) to Low (L) and are dependent on the nature and thickness of subsoils above the water table. The GSI Vulnerability map indicates that the site is located upon an area of Moderate vulnerability but surrounded by areas of high vulnerability. The Groundwater Vulnerability map is shown in Figure 3.10 and the vulnerability ratings are defined in Table 3.1 which has been taken from the Geological Survey of Ireland website.

Fgure 3.10: Groundwater Vulnerability in the Area Surrounding the Alexion Site

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 04-12-2018:03:57:14

Ce<n~fUII,>

•

/ ~onSite

Athlone

• SI- nner Pro ect°or'I Area

SO-Outer Protec: O" ree

)

t N

PM GROUP


IE0312344-22-RP-0001, Issue A 29 Nov 2018


Table 3.1: Groundwater Vulnerability Mapping Guidelines3

Vulnerability Rating

Hydrogeological Conditions

Subsoil Permeability (Type) and Thickness Unsaturated

Zone Karst

Features

High Permeability (sand/gravel)

Moderate Permeability (e.g. sandy

subsoil)

Low Permeability (e.g. Clayey

subsoil, clay and peat)

(Sand/gravel aquifers only)

(<30m radius)

Extreme (E) 0 – 3.0m 0 – 3.0m 0 – 3.0m 0 – 3.0m -

High (H) >3.0m 3.0 – 10.0m 3.0 – 5.0m >3.0m N/A

Moderate (M) N/A >10.0m 5.0 – 10.0m N/A N/A

Low (L) N/A N/A >10.0m N/A N/A

Notes:

(1) N/A = not applicable

(2) Precise permeability values cannot be given at present

(3) Release point of contaminants is assumed to be 1-2m below ground surface

3.4.4 Source Protection Areas

A source Protection Area is a land area that contributes groundwater to a borehole or spring. Figure 3.11 which has been taken from the Geological Survey of Ireland website, shows that the nearest Source Protection area is located 6 km west of the Alexion site.

Figure 3.11: Source Protection

3 Department of the Environment, Community and Local Government (DoECLG), EPA & GSI, (1999), Groundwater

Protection Scheme Guidelines

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 04-12-2018:03:57:14

~A BOY f NEST

Borehole

CREAGH

BELLANAMULLIA

KllHA AHAGH

BUHHAf

DOOVOGE:

Alexion Site

GAHFIH

Betliln«nulla

( t N Borehole

PM GROUP


IE0312344-22-RP-0001, Issue A 29 Nov 2018


3.4.5 Groundwater Wells and Springs

Figure 3.12 which has been taken from the Geological Survey of Ireland website, shows that there are several Boreholes surrounding the Alexion site. Two of these are located 0.5 km to the South-West and 2 no. of these are located within 3km North-west of the site.

Figure 3.12: Groundwater Wells and Springs in the Area Surrounding the Alexion Site

3.4.6 Groundwater Quality

The S.I. No. 9 of 2010, EC Environmental Objectives (Groundwater) Regulations 2010, as amended, give effect to the criteria and standards to be used for classifying groundwater in accordance with the requirements of the Water Framework Directive (WFD). The current status of the groundwater under the Alexion site is classified as Poor.

As both Arran Chemicals and Alkermes are licenced by the EPA, there is a significant ground water quality data set available for the local area. There are no licenced discharges to ground within the immediate area, however a number of historical accidental discharges resulting in shallow groundwater contamination have occurred and been reported to the EPA;

- a leak in a sewer line which contained Volatile Organic Compounds (VOCs) at Arran (reported by Arran as occurring prior to 1997);

- a loss of Trichloroethene (TCE) at Alkermes (1993) and;

- a solvent spill with Tetrachloroethene (PCE) at an undetermined location but resulting in highest concentrations at a borehole installed on the eastern site boundary of Arran Chemicals with Alkermes c. 70 metres northwest of the Alexion site boundary.

Monitoring of groundwater quality at the Alexion site has detected the chlorinated solvents perchloroethylene PCE and TCE at concentrations that exceed both the Groundwater Threshold Value (GTV) and Drinking Water Standards (DWS) for these compounds. The GTV for the total concentration of PCE as 7.5 μg/L and the DWS is 10 μg/L.

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 04-12-2018:03:57:14

PM GROUP


IE0312344-22-RP-0001, Issue A 29 Nov 2018


In the Groundwater Regulations (S.I. 9 of 2010), the threshold value for the sum of PCE+TCE is 7.5g/l.

A review of available historical data was undertaken (by Geosyntec Consultants Ltd.) to confirm the current local groundwater quality and to facilitate representative soil and groundwater sample collection within the Alexion site, in order for the impacts of construction and operation to be fully assessed.

Nine new boreholes were installed to provide a comprehensive assessment of groundwater quality beneath the footprint of the new Biologics Building and surrounding area. Together with two existing boreholes this allowed assessment of the geology, water levels and water quality beneath the area where piling and deepest excavation is required during construction. It should be noted that all of these groundwater samples were analysed for full Volatile Organic (VOC) suite and only PCE was detected above laboratory detection limit. Concentrations exceeding threshold concentrations (7.5ug/l) were noted in groundwater across the footprint of the Biologics Building, with slightly decreasing concentration eastwards towards the location of the surface water attenuation tank. PCE levels have decreased in recent years, this is clear as the highest concentration recorded in 2016 was 377 μg/L, while the highest PCE level recorded at the Alexion site in 2013 was 253 μg/L.

3.5 Surface Water

There are no watercourses within the subject lands of the Alexion site apart from the drainage ditch located in the south of the site. The closest surface water body to the site is Monksland Spring, which flows from east to west, approximately 70 m from the southern site boundary and flows into the Cross River approximately 300 m downstream. The Cross River flows generally towards the southeast and flows into the River Shannon approximately 3.5 km southeast of the site. This can be seen in Figure 3.13 below, which has been taken from the Geological Survey of Ireland website. The Cross river is classified as being of ‘Good’ status and ‘unpolluted’ quality (WFD; 1984 – 2014). The status, however upstream the Cross River is identified as being at risk of not achieving ‘Good’ status (2010 - 2012).

Figure 3.13: Surface Water Map

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 04-12-2018:03:57:14

PM GROUP


IE0312344-22-RP-0001, Issue A 29 Nov 2018


3.5.1 Alexion Storm Water Emissions

Storm water emissions from the Alexion site consist of uncontaminated rainwater runoff from building roofs and other hard standing areas such as the car park, roads and footpaths. There are 3 no. storm water drainage lines at the site as follows:

1. Runoff from the main car park to the west of this Fill Finish and Warehouse Building.

2. Runoff from the Fill Finish and Warehouse Building, the Admin and Laboratory building, the CUB and the Waste Storage and Sprinkler Tank Storage Area to the east of the Biologics Manufacturing Building

3. Runoff from the Biologics Manufacturing Building and the surrounding hard standing area.

Line 3 drains into Line 2 prior to leaving the Alexion site. Line 2 then drains into Line 1 to the west of the Alexion boundary.

It is noted that Line 1 contains storm water runoff from the Alkermes site from both a northerly and easterly direction. Runoff from the Alexion car park to the west of the Fill Finish and Warehouse Building connects to the Alkermes line from the north as it passes through the Alexion site. A line containing Alkermes storm water runoff from the east connects to this Line 1 before it leaves the Alexion site to the west.

Alkermes currently monitors storm water runoff at a location to the west of the Alexion site, which contains the storm water runoff form the Alexion car park discussed above. The results of monitoring in 2017 detected PCE in the Monksland Spring at a concentration of 108μg/l. The results for an Alkermes downstream monitoring point SW2 located in the Cross River, indicate that the PCE concentration attenuates rapidly downstream. The average PCE concentration in SW2 since March 2013 is 12.2 μg/L. SW2 is located on the Monksland Stream just upstream of its confluence with the River Cross.

The AER submitted to the EPA from Alkermes concluded on the matter that “the elevated PCE concentration (>PNEC) in the freshwater stream is localised to a section of Monksland Stream downstream of Monksland Spring and is likely to be of insignificant environmental concern in terms of potential ecological impact to the downstream surface water receptor, the River Cross”.

Figure 3.14 below outlines the storm water drainage system at the Alexion site.

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 04-12-2018:03:57:14

RCCStorm Water Drain

Al ex ion Site Boundary

From Alkermes site to the East

Car park to the west of site

From Alkermes site to the North

1111 Bypass

Hydrocarbon Interceptor

Car park to the north-west of site

----.... Northern portion of site --;t~5~Ciiiii.iii1

----.... Southern portion of site

----.... Off-site Storm Water Line

INN Storm Water Emission Point

Line 3

Line 2

Line 1

PM GROUP


IE0312344-22-RP-0001, Issue A 29 Nov 2018


Figure 3.14: Storm Water Drainage Schematic

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 04-12-2018:03:57:14

PM GROUP


IE0312344-22-RP-0001, Issue A 29 Nov 2018


3.5.2 Ecologically Sensitive Aquatic Environment

The development will not take place within or adjacent to a Natura 2000 site; however 10 no. SACs and 3 no. SPAs have been identified within 15km radius of the Alexion site as follows 9refer to Figure 3.15):

- 000216 River Shannon Callows SAC

- 000440 Lough Ree SAC

- 000576 Fin Lough (Offaly) SAC

- 000580 Mongan Bog SAC

- 001625 Castlesampson Esker SAC

- 001776 Pilgrim’s Road Esker SAC

- 002214 Killeglan Grassland SAC

- 002336 Carn Park Bog SAC

- 002337 Crosswood Bog SAC

- 002339 Ballynamona Bog and Corkip Lough SAC

- 004017 Mongan Bog SPA

- 004064 Lough Ree SPA

- 004096 Middle Shannon Callows SPA

Under the Habitats Directive, an Appropriate Assessment is required to be carried out by the competent authority where a plan or project may impact on the designated site’s conservation status. The Appropriate Assessment must determine whether significant impacts on the status are likely, and if so, recommend avoidance or mitigation measures. An Appropriate Assessment was not included as part of the planning application submitted to Roscommon County Council in connection with the approved extension (Planning Ref No. PD/16/287) at the Alexion site. This was deemed unnecessary by an Appropriate Assessment Screening Report which was carried out.

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 04-12-2018:03:57:14

Mongan Bog SAC/SPA

Y//\

t N

Pilgrim's Road Esker SAC

Castlesampson Esker SAC

Crosswood Bog SAC

s emeen Carn Park Bog SAC

1>,1llymore ~

Lough Ree SPA/SAC

Ho,vor

Ballvmnhon

Cl

~ Ballyd,,ng.u,

Ab~yshlul~ /

PM GROUP


IE0312344-22-RP-0001, Issue A 29 Nov 2018


Figure 3.15: Natura 2000 Sites within 15km of the Alexion Site4

4 Source: National Parks and Wildlife Service, http://webgis.npws.ie/npwsviewer (Annotated by PM Group)

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 04-12-2018:03:57:14

http://webgis.npws.ie/npwsviewer

PM GROUP


IE0312344-22-RP-0001, Issue A 29 Nov 2018


3.6 Air Quality

The EPA manages the national ambient air quality network. The existing environment with regards air quality has been described with reference to the most recently published EPA air quality monitoring data for Ireland

5,6.

The Air Framework Directive deals with each EU member state in terms of "Zones". The Air Quality Standards Regulations 2011 state “The Agency shall establish zones and agglomerations throughout the territory of the State for the purpose of air quality assessment and air quality management”. The zones and agglomerations are defined as follows:

- Agglomeration A: Dublin Conurbation

- Zone B: Cork Conurbation

- Zone C: Other large cities and towns comprising Galway, Limerick, Waterford, Clonmel, Kilkenny, Sligo, Drogheda, Wexford, Athlone, Ennis, Bray, Naas, Carlow, Tralee, Dundalk, Navan, Letterkenny, Celbridge, Newbridge, Mullingar, and Balbriggan.

- Zone D: Rural Ireland, i.e. the remainder of the State excluding Zones A, B and C.

Alexion facility falls under Zone C. The EPA monitors ambient air quality at a number of locations throughout this Zone. Annual mean ambient air quality data for 2016 for all the monitoring stations in Agglomeration C is summarised in Table 3.2 below.

Table 3.2: Annual Mean Ambient Air Quality Data for Monitoring Stations in Agglomeration C for 2016

Pollutant Parameter 2016 Range of Annual Mean

Concentrations Reported at Different Monitoring Stations (µg/m

3)

Hourly Nitrogen Dioxide (NO2) 6.6-11.1

Hourly Oxides of Nitrogen (NOx) 9.7-18.9

Hourly Sulphur Dioxide (SO2) 1.3-3.7

8-Hour Carbon Monoxide (CO) 400

Daily Particulate Matter (PM10) 11.7-17.2

Daily Particulate Matter (PM2.5) 8.0-12.0

8-Hour Ozone (O3) 43.5-49.9

Daily Benzene 0.2

Toluene 0.28-2.07

Ethylbenzene 0.01-0.17

M- and P-Xylene 0.06-0.93

O-Xylene 0-0.22

Monthly Lead (Pb) 0.00923

Monthly Arsenic (As) 0.00005

Monthly Cadmium (Cd) 0.00019

Monthly Nickel (Ni) 0.00067

5 EPA (2017), Air Quality in Ireland 2016 Key Indicators of Ambient Air Quality

6 EPA (2017), 2016 Air Quality Report - supplemental information

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 04-12-2018:03:57:14

PM GROUP


IE0312344-22-RP-0001, Issue A 29 Nov 2018


3.7 Noise

In order to describe the existing noise environment in the vicinity of the Alexion site, baseline surveys were carried out by PM Group on the 30

th and 31

st October 2018. The baseline surveys

were carried out in accordance with the EPA’s NG4 Guidance Note7 and was carried out at three

noise sensitive locations (NSL) in the vicinity of the Alexion site as described in Table 3.3 and Figure 3.15.

As per the NG4 Guidance Note, sound pressure levels at each NSL were measured over;

- three 15-minute periods at all NSLs during the daytime survey (07:00-19:00 hours);

- a single 15-minute period at each NSL during the evening time survey (19:00-23:00 hours); and

- two 15-minute periods at each NSL during the evening time survey (23:00-07:00 hours).

Table 3.3: Description of Noise Monitoring Points

Noise Monitoring Point (NMP)

Location Description Irish Grid Co-

ordinates

N1 Residence ca. 150m beyond the western site boundary of Alexion 200542E, 240903N

N2 Residence located at end of Cluain Broc housing estate, ca. 200m beyond the eastern site boundary of Alexion

201102E, 240779N

N3 Residence located on the Old Galway Road, ca. 180m beyond the south-eastern site boundary of Alexion

201033E, 240632N

Figure 3.15: Nearest NSLs to the Alexion Site included in this Assessment

A summary of the results of the baseline monitoring are presented in the following section.

7 EPA (2016). Guidance Note for Noise: Licence Applications, Surveys and Assessments in Relation to Scheduled

Activities (NG4)

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 04-12-2018:03:57:14

PM GROUP


IE0312344-22-RP-0001, Issue A 29 Nov 2018


3.7.1 Results of Baseline Noise Survey

According to the EPA NG4 Guidance Note, Section 4.4.2, a location can be defined as a ‘Quiet Area’ or an ‘Area of Low Background Noise’ if each of the following criteria is satisfied for that location:

- Average Daytime Background Noise Level ≤40dB LAF90, and;

- Average Evening Background Noise Level ≤35dB LAF90, and;

- Average Night-time Background Noise Level ≤30dB LAF90.

Location N1

The dominant noise source at N1 during the daytime survey was traffic noise from the M6 motorway. The average results for N1 were 53dB LAeq and 47dB LA90 for the daytime period.

The dominant noise source at N1 during the evening time survey was traffic from the M6 motorway. The results for N1 were 50dB LAeq and 44dB LA90 for the evening time period.

The dominant noise source at N1 during the night-time survey was traffic noise from the M6 motorway. The average results for N1 were 45dB LAeq and 41dB LA90 for the night-time period.

Based on the EPA NG4 Guidance Note, N1 is not classified as a ‘Quiet Area’ or an ‘Area of Low Background Noise’ as it does not satisfy the criteria outlined above.

Location N2


The dominant noise source at N2 during the evening time survey was traffic noise from the M6 motorway. The results for N2 were 42dB LAeq and 37dB LA90 for the evening time period.



Location N3


The dominant noise source at N3 during the evening time survey was traffic noise from the M6 motorway. The results for N3 were 51dB LAeq and 44dB LA90 for the evening time period.



Tonal Analysis

Tonal analysis was carried out on the results of all noise surveys. This involved the analysis of the unweighted spectrum of noise levels recorded at each monitoring location with respect to the frequencies (Hz) at which they occurred.

1/3 octave band tonal analysis was employed which involved the measurement of an averaged noise level to represent the frequencies within each third of an octave. These noise levels were then compared with the noise levels calculated for the adjacent 1/3 octave bands. If a noise level meets the criteria outlined in Section 3.1.2 with regard to the noise levels representing the adjacent bands then it is considered tonal, since it is significantly louder than noise levels at similar frequencies.

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 04-12-2018:03:57:14

PM GROUP


IE0312344-22-RP-0001, Issue A 29 Nov 2018


There was one tone identified during the third daytime monitoring period at NSL1 at a level 37dB in the 10,000Hz 1/3 octave band. There were no tones identified during any of the other monitoring periods.

Impulsive Noise

An impulsive noise is a noise that is of short duration (typically less than one second), the sound pressure level of which is significantly higher than the background e.g. hammer blow to metal sheet.

There was no impulsive noise observed during any of the monitoring periods during the daytime, evening time or night-time surveys.

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 04-12-2018:03:57:14

site condition reportin september 2016, alexion was granted permission for a three-storey biologics...

Documents