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Novartis Ringaskiddy Limited
Annual Environmental Report 2013
31-May-2014
IEL Register Number P0006-03
Section 1: Introduction:
IEL Register Number
Name and Location of the Site
Description of Activities at the Site
Company Environmental Policy
Company Organisation Chart for Environmental Management
Current Site Plan
Section 2: Summary Information:
Emissions to Atmosphere Summary
Emissions to Sewer Summary
Surface Water Emissions Report
Agency Monitoring and Enforcement
Waste Management Report
Resource Consumption Record
Complaints Summary
Reported Incidents Summary
Summary of On-Site Incineration Record
Section 3: Management of the Activity:
Environmental Expenditure Summary: Capital and Current
Environmental Management Programme - Proposal
Environmental Management Programme - Report

European Pollutant Release and Transfer Register (PRTR) Report for
2013
Schedule of Environmental Objectives and Targets - 2013 (Update)
Schedule of Environmental Objectives and Targets - 2014
Section 4: Licence Specific Reports:
Report on List I and II Substance Reductions
Tank and Pipeline Testing and Inspection Report
Noise Monitoring Report
Groundwater Monitoring Summary
Energy Audit Report
Effluent Toxicity Report
Environmental Liability Risk Assessment (Update)
Closure, Restoration and Aftercare Management Plan (Update)

Section 1: Introduction:
IEL Register Number
Name and Location of the Site
Description of Activities at the Site
Company Environmental Policy
Company Organisation Chart for Environmental Management
Current Site Plan

IEL Register Number: P0006-03
Name and Location of Site:
Ringaskiddy, County Cork, Ireland
Description of Activities at the Site:
Industry Sector (NACE Code): D21.2
Activity: Manufacture of basic pharmaceutical products
Novartis Ringaskiddy Limited is engaged in the manufacture of active substances for speciality
drugs used in the treatment of immunologic, dermatologic, cardiovascular, oncological and
central nervous system diseases.
Schedule of Activities Licensed:
Paragraph: 5.16
Description: The production of pharmaceutical products including intermediates (production
means the production on an industrial scale by chemical or biological processing).
Paragraph: 11.2 (c)

Description: Disposal or recovery of hazardous waste with a capacity exceeding 10 tonnes per
day involving blending or mixing prior to submission to any of the activities listed in paragraph
11.2 or 11.3
Paragraph 11.2 (e)

Description: Disposal or recovery of hazardous waste with a capacity exceeding 10 tonnes per
day involving solvent reclamation or regeneration.
Paragraph 11.3 (b)

Description: Disposal or recovery of waste in waste incineration plants or in waste co-
incineration plants for hazardous waste with a capacity exceeding 10 tonnes per day.
Paragraph 11.6
Description: Temporary storage of hazardous waste, (other than waste referred to in paragraph
11.5) pending any of the activities referred to in paragraph 11.2, 11.3, 11.5 or 11.7 with a total
capacity exceeding 50 tonnes, other than temporary storage, pending collection, on the site
where the waste is generated.
Company Environmental Policy:
The company's environmental policy is reproduced in full on the following page.

Novartis Ringaskiddy Limited Health, Safety and Environment Policy
As a member of the Novartis Group of companies Novartis Ringaskiddy Limited wants to be known for being a responsible
corporate citizen. This means that we do everything that we can to operate in a manner that is sustainable: Economically,
socially and environmentally in the best interest of long-term success for our enterprise. We expect all our employees to
implement this policy and the Group policy on Corporate Responsibility.
We integrate Health, Safety and Environmental Protection into our business strategies to add value to the enterprise, to
manage risk and to enhance the reputation of the company.
The health and safety of our employees, neighbours, customers and consumers, and the protection of the environ-
ment are company priorities consistently pursued at all levels in the organisation.
We take HSE into account in all business decisions and activities. All departments establish proper structures and al-
locate sufficient resources in order to live up to this policy.
Each employee shall comply with the HSE guidelines and the laws applicable to their area of operational responsibility.
We want to be a leader in Health, Safety and Environmental Protection by managing these disciplines actively, consistently
and efficiently.
We strive for continual improvement in our HSE performance. We measure progress and verify compliance with No-
vartis Corporate HSE guidelines and National regulatory requirements through audits and management reviews. To
this end we set clear annual objectives and targets, which are assessed on an on-going basis.
We foster awareness and a sense of responsibility for HSE among our employees; to this end we provide appropriate
information and training and develop their HSE skills.
We optimise the use of natural resources and minimise the environmental impact of our activities so as to conduct
our business in as sustainable a manner as is possible.

We assess HSE implications to ensure that the benefits of manufacturing new products and introducing new technolo-
gies and processes outweigh remaining risks.
We care about the expectations and concerns of our stakeholders.
We provide our employees with safe workplaces. We promote programmes to maintain or improve the health of our
employees.
We cooperate with our suppliers and contractors and offer assistance to enable them to achieve an HSE performance
matching our own.
We recognise the interest of our employees, neighbours, customers, the authorities and the public at large in our
societal behaviour; and the HSE impacts of our business. We provide relevant information and actively listen to stake-
holders. We openly communicate and provide the information necessary to understand the risks and effects of our
operations on health, safety and the environment.
David Mitchell, 12-Jul-2012
Managing Director, Novartis Ringaskiddy Limited

Company Organisation Chart for Environmental Management:
An overall company organisation chart is reproduced on the following page. Organisation charts
follow this in turn for the two functions involved in day-to-day environmental management:
The Health, Safety and Environment (HSE) Support Unit, which is involved in regulatory
aspects of environmental management; and
The Technical Services Support Unit, which is involved in the day-to-day operation of
environmental protection modules at the facility.
Health Safety & Environment (HSE)
Issue Date: 16 Nov 2012
Revision Number: 29
Approved By: Jimmy OLeary
Jimmy OLeary
Head of HSE
Site Co Ordinator - Shift

Christine Horgan (Part Time) Liam Higgins
Vincent Boyton Liam OSullivan David Montgomery Arthur Cox, Kelly Flanagan, Declan
Betty ODonovan
Occupational Health Nurse
EIHL Services Manager Safety & Security Mgr Process Safety Manager Fire Officer Harrington, Michael Kenneally,
John McIntyre
Dr Jack Cantillon
Rose Scanlan 11 Security Personnel
Occupational Health Physican Richella Murray
OH Administrator
Industrial Hygienist Contract
Part Time
Leonard Scannell
Environmental Analyst
- SU High Level Summary Chart
Martin OSullivan
Head of Tech. Services
Engineering
Stores
Admin Support (1) Coordinator (1)
Operators (1)
Civil, Structural,
Engineering Architectural (CSA)
Support (10) Coordinator (1)
Operator (1)
Maintenance Operations
Maintenance Plant Manager (1)
Facilitator (1) Operators (26)
Coordinators (3) TS Operations Coordinator (1)
Craftsperson's (27) Site Support Lead (1)
Contract craft (27) Training & Development Lead (1)
Apprentices (2)
*Contract
- SU Head of Technical Services ** Apprentice
Martin O Sullivan
CSA Engineering Stores

Maintenance Co-ordinator Co-Ordinator
Site Services Admin
Owen Murphy
Maintenance Facilitator Lorraine OSullivan* Edwin McNally
Kevin Creedon Operator Operator
Maintenance Team Co-ordinators Anthony Cullinane Ken Murphy
Eugene OReilly
James OShea
Declan Moore
Craftsperson's
Anthony Lane Kevin Sexton Engineering Operations
Arthur Depuis* Liam Cox Support Team Operations Facilitator
Damien ODriscoll John Harrington
Barry Walsh* Liam OFlynn*
Dominic Falvey TS Operations Co-ordinator
Brendan Wolohan Mick Barr*
Graham Cato* Eddie Kelleher
Brian Duane Malachy Kennedy
Kevin Warner Site Support Lead
Brian Foster Maurice Brennan*
John Mullaney* Alex Greene
Brian Kenneally Michael Glavin
Noel Aherne* Training & Development Lead
Brian Murphy* Mick Leahy*
Mark Meehan
Brian OLeary Michael OLeary Patricia Kelleher*
Operators
Con Casey* Michael OLeary* Robert Condon*
Daniel Kenneally* Michael Taylor* Robert Slowey Lorcan Aherne Michael Relihan
Derek Costello Nick Smith* Tim Barry Joseph Barry Anthony OLeary
Donal Dennehy* Owen OSullivan John Creedon Mark Finglas
Fiona Foley Owen Wills David Duff Mick Fitton
Frank Williams Pat Healy Martin Kelleher Kevin Hanley
Garrett Murphy* Pat ODonovan* Roy Maye Michael McCarthy
Gavin Clancy* Peter OHalloran Brian Mitchell Joe Murphy
Glen Barton* Pierce Fitzgerald Liam Monaher Sammy ODriscoll
Jer Buckley* Robin ODonovan* Michael Morrissey Declan Curtin
John Cahill Roy Ahern* Sean ODonovan Paul Desmond
John Coleman Roy Casey* Mark OKeeffe Paul Freyne
John Cotter Roy ODonovan* Trevor ORourke Kline Pennefather
John Howard Sean Sexton Neil OSullivan Barry ONeill
John Flanagan* Shane Donnellan
John Lane* Tom ODriscoll* Supports
John ODonovan Wayne Depuis*
Utilities, Tank Farm, Thermal
John Troy* Chris Buckley**
John Wall Eoin Lynch**
Treatment, Solvent Recovery
NIPBI, NRL Campus
Supports PUs , SUs, NIPBI & NRL
Campus
Updated Site Plan
The current site plan (drawing number 000-121005-1 Rev 19) is reproduced as an insert
overleaf.
Also included are:
Drawing Number 000-517043-1 Rev 2 Main Emission Points with Irish Grid Projection; and
Drawing Number 000-517044-1 Rev 1 Main Sampling and Monitoring Points with Irish Grid
Projection.
01 02 03 04 05 06 07 08 09 10
A
A
B B
ACCESS ROAD
TCH
SECURITY FENCE
DI
GATE
720
FENCE
CATCHMENT
663
C ELECTRICAL No.10 CALOR GAS C
655 TANK
SWITCH YARD 664
721
TRUCK
CAT. 9 WAREHOUSE
UNLOADING
BOLLARDS
AREA
TANK FARM
MAIN SWITCHGEAR CONTROL BUILDING (EAST) CAT. 2
VALVE
BUILDING
622 651 HOUSE WAREHOUSE
652 SAFETY
TRANSFORMER SHOWER
POTABLE SOLVENT 666
WATER TANK RECOVERY
(EAST)
PUMP CATCHMENT CATCHMENT CATCHMENT CATCHMENT
SECURITY
GATE 623
HOUSE 621 Nos.7&8 Nos.6&9 Nos. Nos.
E
C CONSTRUCTION CAR PARK 3&4 1&2
FEN
FIRE 653 CAT. 3 & 4
WAREHOUSE
WATER TANK 640 CATEGORY 6.
CATCHMENT
WAREHOUSE
Smoking
Hut
SPILL
No.5 662
BASIN
Bicycle
V V V V Shed
SIAC Container
WC
Rockwell Storage BOLLARDS
Lyne
ce
Canteen
Offi
l
Lyne
Rockwel
ng
D.
Canteen
Dryi
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M.L. TANK
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PJH
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Purcel
GAS STORAGE
D.
ce
Offi
Compound EPS Denco WESP
Offi
BIO DETECTOR SKID PLATFORM
PJH 1
Container
DEL
59
Canteen
DEL
56
Container
DEL
58 661 574
PJH 2
DEL
561
WC
57 DORNAN
Dr
WC
PJH 4
WI I
yi
WI Insulation DEL 55
TRASH
ng Cant
D
IFL
PROJECT
nsul
Workshop Container
DEL Drying Room Office
DEL
54 D
KCH 64
552 ALCOVE &
at
WAREHOUSE
i
Killcronagh
on
een
First Aid Office
ec.
PSC
L
EPS
Aherne El
510 INCINERATOR
Storage
Killcronagh Aherne Elec.
Office
Purcell
WI Office Storage
CONSTRUCTION
543 SSF
LIQUID/VAPOUR
572
Workshop
INCINERATOR
Purcell Scaffold
COMPOUND
553 576
Laydown Area
GATE QUENCH TANKS COMBUSTER
GAS PAD
BMD
550
ner
ner
ner
BMD
TCH
STAINLESS STEEL CARBON STEEL

Contai
Contai
Contai
WORK SHOP WORK SHOP WWTA

WC
PI
WORKSHOP WORKSHOP BULK STORAGE

571
Cont
LIQUID ANNEX TRAILER PARK

BMD
BMD Canteen
BMD BMD
Office
BMD PB 1A
ai
10 9 8 7
PB 2 PB 1
ner
Office
BMD
Office BMD BMD BMD Canteen
BMD BMD
Office
BMD FLAME EXP
Storage
1 2 3 4 5 6 PLATFORM
ARRESTER
471
PROJECTS OFFICE
421 431 TRANSFORMER 575
TRANSFORMER
540 BULIC CHARGING
LIQUID NITROGEN
WASTE WATER TREATMENT ALOX BIN STORE
SKID
CONTROL BUILDING
GATE 554 DHS SKID
ACCESS STAIRS
LAY DOWN TO PIPERACK

470
PSA
OFFICES
512 TEMP ELEC HUT TRANSFORMER AIRLOCK
SWITCHROOM
EAST / WEST CORRIDOR
REDUNDANT
TRANS. PAD
LLER
BLOWER
EQUIPMENT BUILDING
AERATION
CHI
SECURITY FENCE FUEL

STORAGE GLYCOL CHILLERS DIGESTER
TANK
NG
OIL
475
TOW ER
COOLI
MAINTENANCE UTILITY BUILDING AERATION AERATION
ICE PLANT 541
GEN. PAD
COMPOUND
474 SPILL TANK TANK
BASIN
E E
WASTE PACKAGING PSA CLARIFIER
420 AREA
442
CLARIFIER
441 473
DGE
BRI
430
ON
GH
ANALYZER
SATI
LIFT
W EI
MAIN
NEUTRALI
STATION SHED
TRANSFORMER WAREHOUSE EQUALIZATION
451 TANK
SECURITY FENCE
CHEMICAL
STORAGE 472
GATE TECHNICAL SERVICES LABORATORY
432 BUILDING BUILDING
GAS METER
STATION
SECURITY FENCE 342 LOADING DOCK

CANOPY
TRANSFORMER
IRISH GAS
GATE STATION
BICYCLE SHED
ADMINISTRATION
BUILDING GENERAL NOTES:
341
1. ALL LEVELS IN METRES POOLBEG DATUM
H
F F
TC
2. FOR SITE LAYOUT WITH FUTURE STRUCTURES REFER TO 000-121006-1.

DI
CAR PARK 361

SECURITY FENCE
CAR PARK
GUARD HOUSE
SECURITY FENCE
GENERAL LEGEND
NIPBI BUILDING
STORM WATER ESB
RETENTION POND SUB-STATION
BUILDINGS
MAIN ROAD
014 242
BUILDING NUMBER 552
MAIN PLANT ENTRANCE

WATER METER
CAR PARK
HOUSE
FENCING LEGEND
241 CHAINLINK FENCE WITH
G CRANKED CONCRETE POSTS G
2.4m PLASTIC COATED CHAINLINK

FENCE WITH STEEL POSTS
STONE WALL
POND
CONCRETE POST AND RAIL FENCE
BOUNDARY OUTLINE
CE
FEN
OWNER
TECHNICAL OWNER
This document is the property of Novartis Ringaskiddy Limited and is not to be used, reproduced or disclosed
in whole or in part without the prior written permission of Novartis Ringaskiddy Limited.
H H

Ringaskiddy, Co. Cork, Ireland
Drawing Title
OVERALL SITE LAYOUT

SHOWING EXISTING STRUCTURES
REVISION
SHEET DWG.
SCALE 1:1250 SIZE A0 000-121005 SHEET
1 OF
1
DO NOT SCALE
NO. 19
01 02 03 04 05 06 07 08 09 10
Section 2: Summary Information:
Emissions to Atmosphere Summary
Emissions to Sewer Summary
Surface Water Emissions Report
Agency Monitoring and Enforcement
Waste Management Report
Resource Consumption Record
Complaints Summary
Reported Incidents Summary
Summary of On-Site Incineration Record

Emission Point Reference Number 3 (Solid Waste Incinerator)
Emissions to Atmosphere Summary 2013
Parameter Mass Emission (kg) Controlled Discharge (kg)
Carbon Monoxide 11 3,833

Sulphur Dioxide 5 3,833
Oxides of Nitrogen 846 30,660
Total Organic Carbon 6 767
Hydrochloric Acid 1 767
Total Particulates 1 767
Hydrogen Fluoride 7 77
Hydrogen Bromide 9 153
Dioxins and Dibenzofurans 0.000000031 0.000007665
Notes: A summary of the non-compliances reported for Emission Point Reference

Number 03 to the Agency during 2013 is presented on the page after next. More
detailed information on these non-compliances is contained in the Reported
Incidents Summary section of this AER.
Emission Point Reference Number 3
100
90
80
70
60
50
40
30
20
10
0
CO SO2 NOx TOC HCl Dust HF HBr Dioxin
Mass Discharges from Solid Waste Incinerator (first column) Expressed as a

Percentage of the Discharge Regulated Under IEL Register Number P0006-03
(second column): 2013
Legend: CO: Carbon Monoxide

SO2: Sulphur Dioxide
NOx: Oxides of Nitrogen
TOC: Total Organic Carbon
HCl: Hydrochloric Acid
Dust: Particulates
HF: Hydrogen Fluoride
HBr: Hydrogen Bromide
Dioxin: Dioxins and Dibenzofurans
Novartis Ringaskiddy Limited Monitoring Data: Emission Point Reference No. 3
Solid Waste Incinerator:
January to December 2013
Continuous monitoring data submitted to the Environmental Protection Agency for the period of January
to December 2013:
Valid 10 minute means: 12,265 Complying 10 minute means: 12,265
Valid 24 hour means: 1,099 Complying 24 hour means: 1,099
Excursions above Emission Limit Values as outlined in Schedule B 1, IEL Register Number P0006-03:
Twenty-nine Carbon Monoxide (CO) ten-minute means exceeded the relevant ELV for CO during the period of
January to December, 2013. The mass discharges of CO associated with the aforementioned readings were less
than the amount regulated under IEL Register Number P0006-03. A total of 12,265 ten-minute means were
recorded for CO during the period of January to December, 2013. Note that 95% of all 10 minute means recorded
for CO to during the period of January to December, 2013 remained less than 150 mg/Nm 3.
Three CO thirty-minute means exceeded the relevant ELV for CO during the period of January to December, 2013.
The mass discharges of CO associated with the aforementioned readings were less than the amount regulated
under IEL Register Number P0006-03. A total of 4,088 thirty-minute means were recorded for CO during the period
of January to December, 2013.
Compliance with IEL Register Number P0006-03 in terms of ELVs (10 minute; 30 minute; and 24 hour
means) was 100 %, with the exception of three thirty-minute (concentration) means for Carbon Monoxide.
Mass discharges of all parameters (10 minute; 30 minute; and 24 hour means) were in 100 % compliance.
Quarterly and Bi-annual monitoring data submitted to the Environmental Protection Agency for the period
of January to December 2013:
Dioxin and dibenzofuran; metal; and hydrogen fluoride and hydrogen bromide emissions were in 100 %
compliance.
Emission Point Reference Number 04 (Liquid Vapour Incinerator)
Emissions to Atmosphere Summary 2013
Carbon Monoxide 49 18,250

Sulphur Dioxide 172 18,250
Oxides of Nitrogen 7,739 146,000
Total Organic Carbon 26 3,650
Hydrochloric Acid 28 3,650
Total Particulates 99 3,650
Hydrogen Fluoride 27 365
Hydrogen Bromide 106 730
Dioxins and Dibenzofurans 0.000000163 0.0000365
Notes: A summary of the non-compliances reported for Emission Point Reference

Number 04 to the Agency during 2013 is presented on the page after next. More
detailed information on these non-compliances is contained in the Reported
Incidents Summary section of this AER.
100
90
80
70
60
50
40
30
20
10
0
CO SO2 NOx TOC HCl Dust HF HBr Dioxin
Mass Discharges from Liquid Vapour Incinerator (first column) Expressed as a

Percentage of the Discharge Regulated Under IEL Register Number P0006-03
(second column): 2013

Dust: Particulates
HF: Hydrogen Fluoride
HBr: Hydrogen Bromide
Dioxin: Dioxins and Dibenzofurans
Novartis Ringaskiddy Limited Monitoring Data: Emission Point Reference No. 4
Liquid Vapour Incinerator:
January to December 2013
Continuous monitoring data submitted to the Environmental Protection Agency for the period of January
to December 2013:
Valid 24 hour means: 2,555 Complying 24 hour means: 2,555
Excursions above Emission Limit Values as outlined in Schedule 1 (i), IEL Register Number P0006-03:
Twenty-one Carbon Monoxide (CO) ten-minute means exceeded the relevant ELV for CO during the period of
January to December 2013. The mass discharges of CO associated with the aforementioned readings were less
than the amount regulated under IEL Register Number P0006-03. A total of 51,410 ten-minute means were
recorded for CO during the period of January to December 2013. Note that 95% of all 10 minute means recorded
for CO during the period of January to December 2013 remained less than 150 mg/Nm 3.
One Hydrochloric Acid (HCl) thirty-minute mean exceeded the relevant ELV for HCl during the period of January to
December 2013. The mass discharge of HCl associated with the aforementioned reading was less than the amount
regulated under IEL Register Number P0006-03. A total of 17,425 thirty-minute means were recorded for HCl
during the period of January to December 2013. Note that 97% of all thirty-minute means recorded for HCl during
the period of January to December 2013 remained less than 10 mg/Nm 3.
Compliance with IEL Register Number P0006-03 in terms of ELVs (10 minute; 30 minute; and 24 hour
means) was 100 %.
Mass discharges of all parameters (10 minute; 30 minute; and 24 hour means) were in 100 % compliance.
Liquid Vapour Incinerator on-line availability factor: 99.8 %
Quarterly and Bi-annual monitoring data submitted to the Environmental Protection Agency for the
reporting period of January to December 2013:
Dioxin and dibenzofuran; metal; and hydrogen fluoride and hydrogen bromide emissions were in 100 %
compliance.
Emissions to Sewer Summary 2013
Total Suspended Solids 16,962 82,125

Chemical Oxygen Demand 46,608 229,950
Total Phosphorus 589 3,650
Total Nitrogen 1,628 11,680
Total Ammonia 66 1,830
Biochemical Oxygen Demand 1,581 82,125
Copper 4 183
Zinc 3 365
Parameter Discharge (m3) Controlled Discharge (m3)
Flow 188,676 328,500
Parameter Values Controlled Values
pH 6 to 9 6 to 9
Toxicity (Fish) < 3.1 Toxic Units 10 Toxic Units
Toxicity (Invertebrate) < 3.1 Toxic Units 10 Toxic Units
Toxicity (Bacteria) < 2.2 Toxic Units 10 Toxic Units
Notes: Neither copper nor zinc is used in production processes at Novartis Ringaskiddy
Limited.
A detailed summary of the non-compliances reported to the Agency for Emission

Point Reference Number 100 during 2013 is presented in the Reported Incidents
Summary section of this AER.
100
90
80
70
60
50
40
30
20
10
0
TSS COD BOD TP TN NH3-N Cu Zn Flow
Mass Discharges from Wastewater Treatment Plant (first column) Expressed as a

Percentage of the Discharge Regulated Under Industrial Emissions Licence
Register Number P0006-03 (second column): 2013
Legend: TSS: Total Suspended Solids

COD: Chemical Oxygen Demand
BOD: Biochemical Oxygen Demand
TP: Total Phosphorus
TN: Total Nitrogen
NH3-N: Total Ammonia
Cu: Copper
Zn: Zinc
Flow: Flow
Surface Water Emissions Summary 2013
A total of 12 monthly reports were prepared and held on site for Agency inspection in relation to
surface water emissions from the facility during 2013. All discharges of surface water from the
facility were compliant with the requirements of IEL Register Number P0006-03.
A description of the facility's Surface Water Protection System is included on the following
pages.
Novartis Ringaskiddy Limited: Surface Water Protection System
1. General Overview
A significant contribution to environmental protection can be achieved by incorporating the principle of

CONTAINMENT, in addition to the principles of AVOID, REDUCE, REUSE and RECYCLE, in the
design of production facilities. At Novartis Ringaskiddy Limited this has been achieved from a total
concept with contributions from all areas.
The design of the Novartis Ringaskiddy Limited facility incorporates detailed attention to the prevention of
contamination of surface water. Bunded and segregated drainage systems form a major part of this
strategy. Areas where spillage of liquid is possible, such as the Tank Farm or Solvent Recycling Unit, are
bunded to retain spilled material. The bunded water sewer is a stainless steel pipe that drains spillages from
the Tank Farm bunds to one of two Spill Basins, one with a capacity of 299 m3 and the other with a
capacity of 162 m3. This allows the interception of large spillages, which could incapacitate the Wastewater
Treatment Plant. This material can then be treated in an appropriate manner.
The concept adopted for the draining and discharge of storm water run-off is aimed at minimising the
possibility of surface water contamination and preventing the release of contaminated material from a
spillage, firefighting or other incident. All buildings where a fire risk exists are surrounded by an
impermeable apron to intercept any spillages or firefighting water in the event of an incident. Run off is
collected by a buried concrete gravity sewer which feeds a Storm Water Protection Pond (SWRP). The
SWRP was originally sized to hold two hours of the largest fire water demand, in addition to 20 mm of
rainfall over the site paved area, in a total holding capacity of 5,000 m 3. The SWRP is lined with a 2 mm
HDPE liner and is divided into two compartments for operational and maintenance purposes.
Novartis Ringaskiddy Limited engaged the services of Arup Consulting Engineers in mid-2009 to review
the basis for design of the SWRP and this resulted in the issue of the report titled Surface Water Drainage
and Fire Water Retention Pond Assessment in August of 2009. That report was reproduced as in insert to
the 2010 revision of the Annual Environmental Report. One of the key findings of the report was that:
the required volume of fire water to be retained on site will need to be circa 9,000 m In order to
achieve the required storage capacity it will be necessary to raise the level of the embankment and
pond liner around the pond to a level of 19.9 m. This will facilitate a storage volume of 9,100 m
and also include a free board of 200 mm. The free board is required in order to prevent any wind
induced waves spilling over the embankment.
It should be noted that if the pond embankment is raised a further 200 mm to a level of 20.1 m
then this will increase the pond volume to 9,975 m, which would cater for an additional 9,000 m
(0.9 Ha) of development, which is an increase of circa 9% of impervious area across the site. It
should be noted that the general ground level of the pathway surrounding the pond area is higher
than the 20.1 m level.
Civil works were undertaken following the issue of this report to effectively implement the
recommendation as outlined in the second paragraph above. This now means that the retention capacity
on-site has been effectively doubled from an original 5,000 m3 to approximately 10,000 m3.
Uncontaminated storm water routinely discharges, via one of the two compartments, to the storm outfall
sewer, which is located on the opposite ends of the SWRP compartments. The second compartment is
maintained empty and in standby mode. In the event of possible contamination, a deviation above the
background level is sensed by the continuous monitors located on the inlet to the compartments of the
SWRP. This results in the outlet valve of the operational compartment to the storm sewer automatically
closing. Potentially contaminated water can then be gathered in the sealed compartment and subject to
more detailed laboratory assessment. If necessary, this water can be pumped to the site's Wastewater
Treatment Plant for biodegradation.
The flow of surface water run off can be routed to the second compartment of the SWRP once the
continuous analysers have indicated that the quality of the run off has returned to specified levels. This
means that the surface water protection system remains operational even in the event of a potential
problem having been intercepted and quarantined.
Retention capacity monitoring was installed during 2005 to provide for rapid determination of the
available retention capacity in the two compartments of the Storm Water Retention Pond. The system uses
radar probes in each compartment to calculate the volume of water present and this information is fed
back in real time to the Environmental Controls Department (ECD) control room. The information is also
available at other control rooms throughout the facility.
Additional civil work was carried out during 2010, which has further optimized the management of
surface water at the facility. A new module the Low Flow Transfer Station was installed at the point
where surface water flows from the site during periods of rainfall into the SWRP. The Low Flow Transfer
Station is used to automatically intercept low flows of surface water that are flagged by data provided by
continuous environmental analysers. This water is then routed directly to the companys Wastewater
Treatment Plant. The purpose of the module is that the maximum capacity for retaining a major spillage at
the facility is maintained at all times.
Novartis Ringaskiddy Limited engaged the services of Arup Consulting Engineers in late 2010 to evaluate
the existing bunding arrangements for the Tank Farm and the Category 6 Warehouse at Novartis
Ringaskiddy Limited; and compare the outcome of this evaluation with the requirements of Industrial
Emissions Licence (IEL) Register Number P0006-03. A report was subsequently issued on 26-Jan-2013
titled Novartis Ringaskiddy Limited Review of Tank Farm and Category 6 Warehouse Bund Capacity.
This report was in turn revised on foot of a request for clarification from the Agency and reissued on 25-
Mar-2013; and subsequently revised again and reissued on 04-Jul-2013.
The revised report, which was submitted to the Agency, was reproduced as an insert in this section of the
AER for 2012. The report also details the current operational procedures for both Spill Basin 1 and 2 and
their respective capacities. These are the remote bunds serving the Tank Farm area. During the preparation
of this report the company also engaged the services of Arup Consulting Engineers to prepare a risk
assessment titled Novartis Ringaskiddy Limited - Surface Water Protection -Risk Assessment - Multiple
Tank Failure, which evaluated the likelihood of multiple tank failures in multiple catchments and the
impact that this would have on the surface water protection system. This risk assessment, which
compliments the report titled Novartis Ringaskiddy Limited Review of Tank Farm and Category 6
Warehouse Bund Capacity, was originally issued on 11-Feb-2013 and subsequently revised and reissued
again on 28-Jun-2013 and was also reproduced as an insert in this section of the AER for 2012.
The revised report and the revised risk assessment should be read in conjunction with the Surface Water
Drainage and Fire Water Retention Pond Assessment C1438.18 Issue 2 which outlines the design criteria
for the surface water drainage network and fire water retention ponds and which was included as an insert
in this section in the AER for 2010.
In line with the recommendations of the inserted reports a number of additional improvements in respect
of surface water (and ground water) protection were implemented during the course of 2012 and these
included optimising the retention volumes in the facilitys two remote bunds (the Spill Basins) together with
improving the existing bunding arrangements at the Category 6 Warehouse. A more comprehensive closed
circuit television inspection of the surface water draining system beneath the facility was also undertaken
during 2012; together with the implementation of an annual cleaning of both compartments of the
companys storm water retention pond. Some additional remedial work was also undertaken during 2013
on some sections of the surface water drainage system.
2. Warning and Action Levels
Storm water run-off from the site to the SWRP is continuously analysed for Total Organic Carbon (TOC)
and pH. Information from both TOC and pH analysers is continuously fed back to the ECD Control
Room through the site's Distributed Control System (DCS). The DCS enables the ECD to automatically
close the outlets from the SWRP compartments once predefined Action Levels have been recorded by one
or both of the analysers located at the inlet of the SWRP. These Action Levels have been notified to the
Environmental Protection Agency and are set as outlined on the following table:
____________________________________________________________________________________________
SURFACE WATER PROTECTION ACTION LEVELS

____________________________________________________________________________________________
Total Organic Carbon : Action Level : 40 mg/L TOC
pH : Action Levels : Less than 6.5 and

greater than 9.5
____________________________________________________________________________________________
The Action Levels also trigger an audible alarm in the ECD Control Room. This serves to notify ECD
personnel that there may be a potential change in the quality of storm water running off site and that this
water is being gathered and quarantined in one of the SWRP's compartments. This alarm has to be
acknowledged by ECD personnel before it is inactivated. Responding to the alarm does not result in the
outlets from the SWRP automatically opening.
A sample of the water gathered and quarantined in the SWRP can then be taken for more detailed
laboratory analysis. ECD personnel may activate the second standby compartment of the SWRP if the
output from the continuous analysers indicates that the quality of the storm water no longer exceeds the
Action Levels. Water can only be released from the quarantined compartment to the storm water sewer
based on a detailed laboratory analysis.
The surface water protection system also incorporates Warning Level alarms for TOC and pH. These
Warning Levels have been set as follows:
____________________________________________________________________________________________
SURFACE WATER PROTECTION WARNING LEVELS

____________________________________________________________________________________________
Total Organic Carbon : Warning Level : 20 mg/L TOC
pH : Warning Levels : 7.0 to 6.5 and

9.0 to 9.5
____________________________________________________________________________________________
The purpose of setting a Warning Level is to indicate to ECD personnel that there is a potential drift in the
quality of the storm water running off the site. Once these predefined Warning Levels have been reached,
by one or both analysers at the inlet of the SWRP, an audible alarm is activated, via the DCS, in the ECD
Control Room. ECD personnel are then required to acknowledge the alarm and to continue monitoring the
output from the TOC and pH analysers. ECD personnel may then close the outlet from the operational
compartment of the SWRP if there is a continuous drift towards the Action Levels. This anticipates the
automatic response effected by the DCS when the Action Levels are reached. Again, once storm water has
been gathered and quarantined in one of the SWRP's compartments a more detailed laboratory analysis is
required before a decision can be made as to whether the water can be released to the storm water sewer.
3. Reference Drawing Numbers
020-114001-1 that details the site underground storm sewer pipe layout and Storm Water Retention Pond.
020-114005-1 that details the site underground bunded sewer pipe layout and the Spill Basin.
Both drawings were included in SANDOZ (now Novartis) Ringaskiddy Limited's Application to the
Environmental Protection Agency for an Integrated Pollution Control Licence: Attachment Number 2:
Complete application documentation (including drawings) for Water Licence Register Number WP (S)
7/93 (R).
Up-to-date copies are also included as an insert in this document:
020-114001-1 Rev 19
020-114005-1 Rev 31
01 02 03 04 05 06 07 08 09 10
NOTES
:14
5 :40
1
14
n.20
ed .Ja
ign 22
.S n xt,
Dig Owe gTe
y trin BUNDED SEWER NOTES:
rph nS
Mu catio
Lo
1. ALL PIPES ARE STAINLESS STEEL SCHEDULE 10S GRADE TP 316L
2. FOR DETAILS OF BUNDED MANHOLES REFER TO DRAWING No. 020-114009
3. FOR DETAILS OF FLOWMETER CHAMBER REFER TO DWG. 020-114009 A

A
4. DELETED.
5. STORM SEWERS ON THIS DRAWING ARE SHOWN FOR INFORMATION ONLY.

REFER TO DRAWING 020-114001-1 FOR STORM SEWER LAYOUT.
6. FLAT PLATE WELDED ON TEE. TEE IS FACING UPWARDS IN DIRECTION.

GATE
BUNDED SEWER LEGEND
BUNDED SEWER
FENCE
B2
B29
CATCHMENT BUNDED MANHOLES/CLEANOUTS
B30No.10 CALOR GAS

8" TANK BUNDED MANHOLES/CLEANOUTS
J6
B B
TRUCK
B26
NOTE 6
B28 CAT. 9 WAREHOUSE
UNLOADING J39
10"x8" 8" BUNDED SEWER BOLLARDS
REDUCER AREA B27
DOUBLE GULLY FOR

TRUCK UNLOADING TANK FARM
B20
N SWITCHGEAR 6"-WBW-285025-D3
CONTROL BUILDING (EAST) CAT. 2
B34 B24 VALVE
BUILDING HOUSE WAREHOUSE
IL.27.325
10"- W BW - 285026- D3
SAFETY
SFORMER SHOWER
SOLVENT
RECOVERY
Clean out
Clean out (EAST)
6"-WBW-285020-D3 6"-WBW-285021-D3 DRAINAGE PIT
6"-WBW-285010-D3 DRAINAGE PIT
IL.27.036 6"-WBW-285011-D3
C
CATCHMENT
B21 CATCHMENT IL.26.680
CATCHMENT CATCHMENT CLEANOUT
CLEANOUT
6"
C
B14 B13
Nos.7&8 Nos.6&9 12"x10"
REDUCER
Nos. Nos.
B35
IL.26.680 3&4 1&2 DRAINAGE PIT
B41
CAT. 3 & 4
REDUCER
6"-WBW-285019-D3 IL.26.500
DRAINAGE PIT
WAREHOUSE
6"-WBW-285009-D3
6"-WBW-285012-D3 B15 CATEGORY 6.
6"- W BW - 285029- D3
(C.O.) B19
B22
8"- W BW - 285018- D3
4"- W BW - 285007- D3
CATCHMENT 10"-WBW-285005-D3 31
6"- W BW - 285008- D3
SPILL
(C.O.) B18
Clean out WAREHOUSE
6"- W BW - 285004- D3
B17 No.5
BASIN 6"-WBW-285015-D3
IL.27.060
IL=25.885 J40 B31
B23 REFERENCE DRAWINGS
B4
12"-WBW-285022-D3
ST221
NOTE 5 B36 6"-WBW-285023-D3 6" PUMPED FROM BUNDED 6" 6" J3 J6 B12 6"
IL=25.450 B32.1 B32 IL.27.050 B2 B42
SEWER HOLDING TANK
GAS STORAGE M.L. TANK
6"- W BW - 285004- D3
D
BLANKED 6"
WESP D
BIO DETECTOR SKID
E 789.350
PLATFORM
N 526.900
IL. 26.425
SCHEDULE OF BUNDED MANHOLES/CLEANOUTS
Manhole Cover Invert Northing Easting

PROJECT TRASH Junction Level Level
ALCOVE & Number
WAREHOUSE B1 27.928 27.049 516.770 706.113
INCINERATOR B2 - 26.861 516.770 734.550
LIQUID/VAPOUR J3 - 26.471 516.800 776.125
B4 27.874 25.888 516.800 867.800

SSF INCINERATOR B5 25.310 23.603 448.500 867.705
J6 - 26.368 516.800 789.275
B10 25.008 23.963 448.500 925.200
B11 24.772 22.407 373.876 867.742

QUENCH TANKS COMBUSTER B12 27.645 26.170 516.720 796.350
B13 28.443 27.100 554.750 797.100

E GAS PAD E
B14 28.525 27.170 554.800 789.350
WWTA B15 28.450 27.980 535.640 785.865

6"
B17 28.190 27.118 531.500 706.540
6"-WBW-285003-D3
B5
B10 B18 28.181 27.125 533.530 706.090
IL.23.940 BULK STORAGE IL.23.940

DRAINAGE OVERFLOW TO STORM
OVERFLOW TO STORM
B19 28.176 27.644 536.880 703.880
CHANNEL
LIQUID ANNEX (FLOWMETER) B37 TRAILER PARK B20 34.483 31.850 586.607 734.096
PB 1A 6"-WBW-285024-D3 B38 FLANGED RODDING EYE
PB 2 PB 1 150mm IL.23.800 B21 28.199
27.488
27.465
557.485 683.370
FLAME EXP STAINLESS
OVERFLOW TO STORM FLANGED RODDING EYE
B22 28.132 27.372 536.097 683.440
STEEL PIPE PLATFORM
ARRESTER IL.23.600
B23 28.051 27.170 520.192 683.440
B24 34.330 - 584.031 720.438
B26 24.827 31.410 598.470 715.260

TRANSFORMER
B27 33.510 32.365 597.275 754.150
TRANSFORMER B28 33.437 32.383 600.000 755.255

BULIC CHARGING
WASTE WATER TREATMENT ALOX BIN STORE B29 33.386 32.593 620.000 755.255
LIQUID NITROGEN
SKID DHS SKID CONTROL BUILDING B30 33.395 32.549 616.000 756.100
ACCESS STAIRS B31 28.076 26.285 522.190 707.730

B32 27.926 27.020 517.000 705.290
F PSA F
TEMP ELEC HUT TRANSFORMER AIRLOCK 6" B34 34.582 31.235 583.960 706.530
B35 28.284 550.575 706.300
EAST / WEST CORRIDOR B36 26.700 25.535 517.575 607.800
B37 25.400 23.490 440.600 867.730

TRANS. PAD
B38 24.500 23.800 440.985 899.665

BLOWER
J39 597.828 736.150
BUILDING
FUEL AERATION J40 521.202 705.931
GLYCOL CHILLERS OVERFLOW TO DIGESTER
TANK B41 27.698 26.900 544.627 813.629
NG
STORM SEWER
OIL
TOW ER
COOLI
ST712 B42 27.721 26.100 516.223 813.629

UTILITY BUILDING NOTE 5 AERATION AERATION
ICE PLANT
GEN. PAD
SPILL
B11 TANK TANK
BASIN
SECURITY FENCE
GATE
CLARIFIER
720
PSA
FENCE
663
IL.22.355 ELECTRICAL
SWITCH YARD
721
655
CATCHMENT
No.10 CALOR GAS
TANK
664
TRUCK
CAT. 9 WAREHOUSE
UNLOADING
BOLLARDS
AREA
TANK FARM
VALVE
BUILDING
622 651 HOUSE WAREHOUSE
652 SAFETY
TRANSFORMER SHOWER
POTABLE SOLVENT 666
WATER TANK RECOVERY
(EAST)
PUMP
CLARIFIER
SECURITY CATCHMENT CATCHMENT CATCHMENT CATCHMENT
GATE 623
CONSTRUCTION CAR PARK 3&4 1&2
FIRE 653 CAT. 3 & 4
WAREHOUSE
SPILL
CATCHMENT
WAREHOUSE 662
No.5
BASIN
G
V V V V V V
BOLLARDS
M.L. TANK
G
DGE
GAS STORAGE

WC. KTN. 661 574
DORNAN
ELECTRICAL
PROJECT
561 TRASH
C/S/A
ALCOVE &
WAREHOUSE
510 552 INCINERATOR
BRI
CONSTRUCTION
MECH.
543 SSF
LIQUID/VAPOUR
572
INCINERATOR
COMPOUND Smoking
Hut
553 576
BMD
STAINLESS STEEL
BMD
CARBON STEEL
550 GAS PAD
WORK SHOP WORK SHOP WWTA
ON
LIQUID PB 1A ANNEX TRAILER PARK 571

GH
PB 2 PB 1
FLAME EXP
PLATFORM
ANALYZER
ARRESTER
SATI
471
LIFT
575
W EI
TRANSFORMER
OFFICES TRANSFORMER
540 BULIC CHARGING
LIQUID NITROGEN
GATE 421 431 554
SKID
CONTROL BUILDING
CONSTRUCTION MANAGEMENT OFFICES
LAY DOWN 470
PSA
TEMP ELEC HUT TRANSFORMER AIRLOCK
SWITCHROOM
MAIN
NEUTRALI
REDUNDANT
TRANS. PAD
LLER
BLOWER
EQUIPMENT BUILDING
AERATION
CHI
SECURITY FENCE FUEL
TANK
NG
OIL
475
TOW ER
SHED
COOLI
ICE PLANT 541
GEN. PAD
COMPOUND
474 SPILL TANK TANK
BASIN
STATION
420 AREA
442
CLARIFIER
441 473
430
ON
ANALYZER
SATI
LIFT
MAIN
NEUTRALI
STATION SHED
WAREHOUSE EQUALIZATION
EQUALIZATION
TRANSFORMER
WAREHOUSE
451 TANK
SECURITY FENCE
CHEMICAL
STORAGE 472
TRANSFORMER 432 BUILDING BUILDING

GAS METER
STATION
SECURITY FENCE 342
TANK
TRANSFORMER
IRISH GAS
GATE STATION
BICYCLE SHED
ADMINISTRATION
BUILDING
341
CAR PARK 361

SECURITY FENCE
CAR PARK
GUARD HOUSE
SECURITY FENCE
NIPBI
NIPBI BUILDING
EXP.
STORM WATER ESB
CHEMICAL 014
242
MAIN ROAD
MAIN PLANT ENTRANCE
STORAGE WATER METER

HOUSE
241
TECHNICAL SERVICES LABORATORY

BUILDING BUILDING KEY PLAN
GAS METER OWNER TECHNICAL OWNER

STATION This document is the property of Novartis Ringaskiddy Limited and is not to be used, reproduced or disclosed
H H

LOADING DOCK Drawing Title

SECURITY FENCE CANOPY
SITE - UNDERGROUND PIPING

BUNDED SEWER LAYOUT
TRANSFORMER
IRISH GAS REVISION
SCALE 1:500 SHEET
A0
DWG.
020-114005 SHEET 1 OF 1
STATION DO NOT SCALE
SIZE NO. 31
01 02 03 BICYCLE SHED 04 05 06 07 08 09 10
Agency Monitoring and Enforcement Summary 2013
The Environmental Protection Agency undertook unannounced emission sampling and analysis
for the following emission points during 2013:
Emission Point Reference Number 100 (Discharge from Wastewater Treatment Plant):
17-Jul-2013
Emission Point Reference Number SW1 (Surface Water Discharge Point):
17-Jul-2013
Emission Point Reference Number W1 (Incinerator Effluent Discharge Point):
This emission point was not sampled on 17-Jul-2013 as the main section of the Liquid Vapour
Incinerator was shutdown for annual maintenance and inspection.
The results reported for the various samples were compliant with the requirements of IEL
Register Number P0006-03.
Catalyst Environmental also sampled the Liquid Vapour Incinerator for emissions of Total
Particulate Matter, Hydrogen Chloride, Hydrogen Fluoride, Hydrogen Bromide, Total VOCs (as
carbon), Oxides of Nitrogen (as NO2), Sulphur Dioxide and Carbon Monoxide on 07-Mar-2103.
The results reported were compliant with the requirements of IEL Register Number P0006-03.
The Agency did not issue any written notification of non-conformance during 2013.
The Agency issued a number of Compliance Investigations (CI) during 2013, which were
tracked through the Agencys ALDER reporting portal. A total of eight CI Actions; and two CI
Instructions were issued and these are outlined on the following page.
The CIs arose from an audit that the Agency undertook of the facility on 23-Apr-2013.
Novartis
Integrity testing of mobile bunds
Ringaskiddy CI Action 30/08/2013 Closed
on-site
Limited
Update appendix B of the report
Novartis
titled ' Review of Tank Farm and
Category 6 warehouse bund
Limited
capacity'
Novartis Testing of bunds in accordance
CI
Ringaskiddy with BS8007 and/or Agency N.A. N.A.
Instruction
Limited guidance
Novartis Difference between standards
Ringaskiddy CI Action BSP16 and BS8007 other than 07/06/2013 Closed
Limited duration of the test
Novartis
CI If any bunds are replaced on site
Ringaskiddy N.A. N.A.
Instruction keep a written record of this
Limited
Novartis
Site policy for bunds that fail
integrity testing
Limited
Novartis
Ringaskiddy CI Action Bund Emptying Procedure 28/06/2013 Closed
Limited
Novartis
Update and amendment of bund
checklist
Limited
Novartis
Annual Environmental Report for
2012
Limited
Pump discharge valve and an
Novartis
isolation valve from the road
tanker spool are located outside
Limited
spill basin 1
Waste Management Record 2013
Further to Condition 10.10.; and Schedules C.4 and D.; of IEL Register Number P0006-03,
Novartis Ringaskiddy Limited wishes to submit the relevant data for waste management
operations, during 2013, to the Environmental Protection Agency (EPA). This information is
listed in the relevant waste summary pages from the Agencys electronic reporting proforma,
which forms Attachment 1 to this section of the AER. An analysis of this data is included in
Attachment 2 to this section to allow a clearer differentiation to be made between on- and off-
site recovery, treatment and disposal.
Results from the analyses of the companys wastewater treatment plant sludge to meet the
requirements of Schedule C.4 of IEL Register Number P0006-03 are presented in Attachment
Number 3 of this report. Note that this material is first dried and subsequently incinerated in
licenced facilities. Following a request from the Agency the company is currently in the process
of generating additional compositional data on the wastewater treatment plant sludge; and this
data will be used as part of the data set to be input into the Agencys hazardous waste
classification tool.
All other relevant waste analytical data will be held at the facility for inspection by the Agency.
Attachment Number 1
Sheet : Treatment Transfers of Waste AER Returns Workbook 15/4/2014 17:10
5. ONSITE TREATMENT & OFFSITE TRANSFERS OF WASTE | PRTR# : P0006 | Facility Name : Novartis Ringaskiddy Limited | Filename : P0006_2013.xls | Return Year : 2013 | 15-04-2014 17:11
5 82 Please enter all quantities on this sheet in Tonnes 0
Haz Waste : Name and
Licence/Permit No of Next
Destination Facility Non Haz Waste : Address of Next Name and License / Permit No. and
Quantity Haz Waste: Name and Destination Facility Address of Final Recoverer / Actual Address of Final Destination
(Tonnes per Licence/Permit No of Non Haz Waste: Address of Disposer (HAZARDOUS WASTE i.e. Final Recovery / Disposal Site
Year) Method Used Recover/Disposer Recover/Disposer ONLY) (HAZARDOUS WASTE ONLY)
Waste
European Waste Treatment Location of
Transfer Destination Code Hazardous Quantity T/Year
Description of Waste Operation M/C/E Method Used Treatment Name and Licence / Permit No. of Recoverer / Disposer / Broker Address of Recoverer / Disposer / Broker Name and Address of Final Destination i.e. Final Recovery / Disposal Site (HAZARDOUS WASTE ONLY) Licence / Permit No. of Final Destination i.e. Final Recovery / Disposal Site (HAZARDOUS WASTE ONLY)
Sava
Sonderabfallverbrennungsa
Veolia Environmental nlagen
Services Technical Solutions GmbH,A51G00508,Osterwe
Limited,EPA Waste Licence Corrin,Fermoy,County ute,1,Brunsbuttel,25541,Ger Osterweute,1,Brunsbuttel,25
To Other Countries 06 02 05 Yes 0.033 other bases D10 M Weighed Abroad Number W0050-2 Cork,.,Ireland many 541,Germany
Novartis Ringaskiddy
Limited,IPPCL Register
Novartis Ringaskiddy Number P0006-
Limited,IPPCL Register Ringaskiddy,County Cork, , 03,Ringaskiddy,County Ringaskiddy,County
Within the Country 07 05 01 Yes 359.221 aqueous washing liquids and mother liquors D10 C Number P0006-03
Volume Calculation Onsite of generation ,Ireland Cork,.,.,Ireland Cork,.,.,Ireland
Veolia Environmental Lagan Cement

Services Technical Solutions Limited,IPPCL P0487-
Limited,EPA Waste Licence Corrin,Fermoy,County 06,Killaskillen,Kinnegad,Cou Killaskillen,Kinnegad,County
Within the Country 07 05 01 Yes 1722.816 aqueous washing liquids and mother liquors R2 M Weighed Offsite in Ireland Number W0050-2 Cork,.,Ireland nty Meath,MEATH,Ireland Meath,MEATH,Ireland
Veolia Environmental
Services (UK)
Veolia Environmental Limited,BS51931E,Bridges
Services Technical Solutions Road,Ellesmere Port,South Bridges Road,Ellesmere
Limited,EPA Waste Licence Corrin,Fermoy,County Wirral,CH65 4EQ,United Port,South Wirral,CH65
To Other Countries 07 05 01 Yes 743.685 aqueous washing liquids and mother liquors D10 M Weighed Abroad Number W0050-2 Cork,.,Ireland Kingdom 4EQ,United Kingdom
Veolia Environmental Veolia Sotrenor,DCVC-EIM-

Services Technical Solutions FT n 2005-195,Route Route
Limited,EPA Waste Licence Corrin,Fermoy,County d'Harnes,62,Courrieres ,FR d'Harnes,62,Courrieres ,FR
To Other Countries 07 05 01 Yes 1901.675 aqueous washing liquids and mother liquors R1 M Weighed Abroad Number W0050-2 Cork,.,Ireland 62710,France 62710,France
Sava
To Other Countries 07 05 01 Yes 28.046 aqueous washing liquids and mother liquors D10 M Weighed Abroad Number W0050-2 Cork,.,Ireland many 541,Germany
other organic solvents, washing liquids and Limited,IPPCL Register Ringaskiddy,County Cork, , 03,Ringaskiddy,County Ringaskiddy,County
Within the Country 07 05 04 Yes 1984.747 mother liquors R1 C Number P0006-03
Within the Country 07 05 04 Yes 249.208 mother liquors D8 E Number P0006-03
other organic solvents, washing liquids and Limited,IPPCL Register Ringaskiddy,County Cork, , 03,Ringaskiddy, ,County Ringaskiddy, ,County Cork,
Volume Calculation Onsite of generation ,Ireland Cork, ,Ireland ,Ireland
| PRTR# : P0006 | Facility Name : Novartis Ringaskiddy Limited | Filename : P0006_2013.xls | Return Year : 2013 | Page 1 of 8

Waste

other organic solvents, washing liquids and Limited,EPA Waste Licence Corrin,Fermoy,County 06,Killaskillen,Kinnegad,Cou Killaskillen,Kinnegad,County
Within the Country 07 05 04 Yes 4647.786 mother liquors R2 M Weighed Offsite in Ireland Number W0050-2 Cork,.,Ireland nty Meath,MEATH,Ireland Meath,MEATH,Ireland
MP Storage and
Veolia Environmental Blending,WML60102,Deep
Services Technical Solutions Water Wharf,Cargo Deep Water Wharf,Cargo
other organic solvents, washing liquids and Limited,EPA Waste Licence Corrin,Fermoy,County Fleet,Middlesborough,TS3 Fleet,Middlesborough,TS3
To Other Countries 07 05 04 Yes 396.94 mother liquors R2 M Weighed Abroad Number W0050-2 Cork,.,Ireland 8AS,United Kingdom 8AS,United Kingdom
Sava
other organic solvents, washing liquids and Limited,EPA Waste Licence Corrin,Fermoy,County ute,1,Brunsbuttel,25541,Ger Osterweute,1,Brunsbuttel,25
To Other Countries 07 05 04 Yes 21.545 mother liquors D10 M Weighed Abroad Number W0050-2 Cork,.,Ireland many 541,Germany
Veolia Environmental SITA Ecoservices Treatment

Services Technical Solutions BV,EMT/2008/2694,Bedrijve Bedrijvenpark Tewnte
other organic solvents, washing liquids and Limited,EPA Waste Licence Corrin,Fermoy,County npark Tewnte 243,.,.,7602 243,.,.,7602
To Other Countries 07 05 04 Yes 62.02 mother liquors R2 M Weighed Abroad Number W0050-2 Cork,.,Ireland Almelo,Netherlands Almelo,Netherlands
Within the Country 07 05 10 Yes 0.3631 other filter cakes and spent absorbents D10 M Weighed Number P0006-03
Onsite of generation ,Ireland Cork,.,.,Ireland Cork,.,.,Ireland
Sava
To Other Countries 07 05 10 Yes 40.537 other filter cakes and spent absorbents D10 M Weighed Abroad Number W0050-2 Cork,.,Ireland many 541,Germany
ERAS ECO Limited,EPA
sludges from on-site effluent treatment Waste Licence Permit Foxhole,Youghal,County
Within the Country 07 05 12 No 745.26 other than those mentioned in 07 05 11 R1 M Weighed Offsite in Ireland Number W0211-01 Cork, ,Ireland
solid wastes containing dangerous Limited,IPPCL Register Ringaskiddy,County Cork, , 03,Ringaskiddy,County Ringaskiddy,County
Within the Country 07 05 13 Yes 2.55587 substances D10 M Weighed Number P0006-03
Sava
solid wastes containing dangerous Limited,EPA Waste Licence Corrin,Fermoy,County ute,1,Brunsbuttel,25541,Ger Osterweute,1,Brunsbuttel,25
To Other Countries 07 05 13 Yes 13.184 substances D10 M Weighed Abroad Number W0050-2 Cork,.,Ireland many 541,Germany
Greenstar Recycling Sarsfieldcourt Industrial
(Munster) Limited,EPA Estate,Sarsfield
Waste Permit Number Court,Glanmire,County
Within the Country 15 01 01 No 60.26 paper and cardboard packaging R3 M Weighed Offsite in Ireland W0136-03 Cork,Ireland
Limited,IPPCL Register Ringaskiddy,County Cork, ,
Within the Country 15 01 02 No 0.14728 plastic packaging D10 M Weighed Number P0006-03
Onsite of generation ,Ireland

Waste
Services Technical Solutions
Limited,EPA Waste Licence Corrin,Fermoy,County
Within the Country 15 01 02 No 10.081 plastic packaging R3 M Weighed Offsite in Ireland Number W0050-2 Cork,.,Ireland
Within the Country 15 01 03 No 0.03252 wooden packaging D10 M Weighed Number P0006-03
Within the Country 15 01 03 No 39.602 wooden packaging R3 M Weighed Offsite in Ireland W0136-03 Cork,Ireland
G. Keohane Pallets
Recycling Limited,WCP-CK- Kilnap,Old Mallow
Within the Country 15 01 03 No 51.84 wooden packaging R3 M Weighed Offsite in Ireland 08-2570-01 Road,Cork, ,Ireland
Waste Recovery Services
(Fermoy) Limited,EPA
Waste Licence Number Cullenagh,Fermoy,County
Within the Country 15 01 03 No 33.38 wooden packaging R3 M Weighed Offsite in Ireland W0107-3 Cork, ,Ireland
Cork Metal Company
Limited (Clearcircle
Environmental),WCP-LK-08-
Within the Country 15 01 04 No 103.03 metallic packaging R4 M Weighed Offsite in Ireland 589-01 Dublin Hill, ,Cork, ,Ireland
Within the Country 15 01 06 No 0.45072 mixed packaging D10 M Weighed Number P0006-03
packaging containing residues of or Limited,IPPCL Register Ringaskiddy,County Cork, , 03,Ringaskiddy,County Ringaskiddy,County
Within the Country 15 01 10 Yes 28.39577 contaminated by dangerous substances D10 M Weighed Number P0006-03
Sava
packaging containing residues of or Limited,EPA Waste Licence Corrin,Fermoy,County ute,1,Brunsbuttel,25541,Ger Osterweute,1,Brunsbuttel,25
To Other Countries 15 01 10 Yes 29.151 contaminated by dangerous substances D10 M Weighed Abroad Number W0050-2 Cork,.,Ireland many 541,Germany
Veolia Environmental Services Technical Solutions
Services Technical Solutions Limited,EPA Waste Licence
packaging containing residues of or Limited,EPA Waste Licence Corrin,Fermoy,County Number W0050-2,Corrin, Corrin, ,Fermoy,County
Within the Country 15 01 10 Yes 1.283 contaminated by dangerous substances R4 M Weighed Offsite in Ireland Number W0050-2 Cork,.,Ireland ,Fermoy,County Cork,Ireland Cork,Ireland
Services (UK)
packaging containing residues of or Limited,EPA Waste Licence Corrin,Fermoy,County Wirral,CH65 4EQ,United Port,South Wirral,CH65
To Other Countries 15 01 10 Yes 0.384 contaminated by dangerous substances D10 M Weighed Abroad Number W0050-2 Cork,.,Ireland Kingdom 4EQ,United Kingdom
absorbents, filter materials (including oil Limited,IPPCL Register
filters not otherwise specified), wiping Novartis Ringaskiddy Number P0006-
cloths, protective clothing contaminated by Limited,IPPCL Register Ringaskiddy,County Cork, , 03,Ringaskiddy,County Ringaskiddy,County
Within the Country 15 02 02 Yes 29.02006 dangerous substances D10 M Weighed Number P0006-03

Waste
Sava
absorbents, filter materials (including oil Veolia Environmental nlagen
filters not otherwise specified), wiping Services Technical Solutions GmbH,A51G00508,Osterwe
cloths, protective clothing contaminated by Limited,EPA Waste Licence Corrin,Fermoy,County ute,1,Brunsbuttel,25541,Ger Osterweute,1,Brunsbuttel,25
To Other Countries 15 02 02 Yes 21.781 dangerous substances D10 M Weighed Abroad Number W0050-2 Cork,.,Ireland many 541,Germany
absorbents, filter materials, wiping cloths Novartis Ringaskiddy
and protective clothing other than those Limited,IPPCL Register Ringaskiddy,County Cork, ,
Within the Country 15 02 03 No 1.44815 mentioned in 15 02 02 D10 M Weighed Number P0006-03
absorbents, filter materials, wiping cloths Services Technical Solutions
and protective clothing other than those Limited,EPA Waste Licence Corrin,Fermoy,County
Within the Country 15 02 03 No 431.24 mentioned in 15 02 02 R5 M Weighed Offsite in Ireland Number W0050-2 Cork,.,Ireland
KMK Metals Recycling

Limited,Recycling
Veolia Environmental Certification Number RC-
discarded equipment containing hazardous Services Technical Solutions 003438,Cappincur Industrial Cappincur Industrial
components (16) other than those Limited,EPA Waste Licence Corrin,Fermoy,County Estate,Daingean Estate,Daingean
Within the Country 16 02 13 Yes 1.537 mentioned in 16 02 09 to 16 02 12 R4 M Weighed Offsite in Ireland Number W0050-2 Cork,.,Ireland Road,County Offaly, ,Ireland Road,County Offaly, ,Ireland
organic wastes containing dangerous Limited,IPPCL Register Ringaskiddy,County Cork, , 03,Ringaskiddy,County Ringaskiddy,County
Tradebe Fawley
Veolia Environmental Limited,ERP/FP3935KL,Cha
Services Technical Solutions rlston Charlston
gases in pressure containers (including Limited,EPA Waste Licence Corrin,Fermoy,County Road,Hardley,Southampton, Road,Hardley,Southampton,
To Other Countries 16 05 04 Yes 0.037 halons) containing dangerous substances D10 M Weighed Abroad Number W0050-2 Cork,.,Ireland SO45 3ZA,United Kingdom SO45 3ZA,United Kingdom
laboratory chemicals, consisting of or Novartis Ringaskiddy Number P0006-
containing dangerous substances, including Limited,IPPCL Register Ringaskiddy,County Cork, , 03,Ringaskiddy,County Ringaskiddy,County
Within the Country 16 05 06 Yes 13.06746 mixtures of laboratory chemicals D10 M Weighed Number P0006-03
Sava
laboratory chemicals, consisting of or Services Technical Solutions GmbH,A51G00508,Osterwe
containing dangerous substances, including Limited,EPA Waste Licence Corrin,Fermoy,County ute,1,Brunsbuttel,25541,Ger Osterweute,1,Brunsbuttel,25
To Other Countries 16 05 06 Yes 0.024 mixtures of laboratory chemicals D10 M Weighed Abroad Number W0050-2 Cork,.,Ireland many 541,Germany
Sava
discarded inorganic chemicals consisting of Limited,EPA Waste Licence Corrin,Fermoy,County ute,1,Brunsbuttel,25541,Ger Osterweute,1,Brunsbuttel,25
To Other Countries 16 05 07 Yes 5.68 or containing dangerous substances D10 M Weighed Abroad Number W0050-2 Cork,.,Ireland many 541,Germany
Sava
discarded organic chemicals consisting of Limited,EPA Waste Licence Corrin,Fermoy,County ute,1,Brunsbuttel,25541,Ger Osterweute,1,Brunsbuttel,25

Waste
Rilta Environmental
Limited,EPA Waste Licence
W0192-03,Grants
Rilta Environmental Grants Drive,Block Drive,Block 402,Greenogue Grants Drive,Block
Limited,EPA Waste Licence 402,Greenogue Business Business 402,Greenogue Business
Within the Country 16 06 02 Yes 0.121 Ni-Cd batteries R4 M Weighed Offsite in Ireland Number W0192-03 Park,Rathcoole,Ireland Park,Rathcoole,Ireland Park,Rathcoole,Ireland
Rilta Environmental Grants Drive,Block
Limited,EPA Waste Licence 402,Greenogue Business
Within the Country 16 06 04 No 0.13 alkaline batteries (except 16 06 03) R4 M Weighed Offsite in Ireland Number W0192-03 Park,Rathcoole,Ireland
Johnson Matthey
Veolia Environmental plc,VP3430BN/PCC/JMP/1
Services Technical Solutions 1/07,Orchard Orchard
spent catalysts contaminated with Limited,EPA Waste Licence Corrin,Fermoy,County Road,Royston,Hertfordshire, Road,Royston,Hertfordshire,
To Other Countries 16 08 07 Yes 10.926 dangerous substances R8 M Weighed Abroad Number W0050-2 Cork,.,Ireland SG8 5HE,United Kingdom SG8 5HE,United Kingdom
Heraeus Precious Metals
GmbH &
Co.,F44RD0069,Heraeusstr
spent catalysts contaminated with Heraeus Precious Metals Heraeusstrasse 12 - 14,.,.,D- asse 12 - 14,.,.,D-63450 Heraeusstrasse 12 - 14,.,.,D-
To Other Countries 16 08 07 Yes 84.926 dangerous substances R8 M Weighed Abroad GmbH & Co.,F44RD0069 63450 Hanau,Germany Hanau,Germany 63450 Hanau,Germany
mixture of concrete, bricks, tiles and Ashgrove Recycling,EPA Churchfield Industrial
ceramics other than those mentioned in 17 Waste Licence Number Estate,John F. Connolly
Within the Country 17 01 07 No 72.48 01 06 D5 M Weighed Offsite in Ireland W0147-01 Road,Cork, ,Ireland
Cork Metal Company
Within the Country 17 04 05 No 85.1 iron and steel R4 M Weighed Offsite in Ireland 589-01 Dublin Hill, ,Cork, ,Ireland
Cork Metal Company
cables other than those mentioned in 17 04 Environmental),WCP-LK-08-
Within the Country 17 04 11 No 4.4 10 R4 M Weighed Offsite in Ireland 589-01 Dublin Hill, ,Cork, ,Ireland
bottom ash and slag other than those Limited,EPA Waste Licence Corrin,Fermoy,County
Within the Country 19 01 12 No 1.92 mentioned in 19 01 11 D14 M Weighed Offsite in Ireland Number W0050-2 Cork,.,Ireland
Greenstar Holdings Limited
bottom ash and slag other than those (Knockharley Knockharley,Navan,County
Within the Country 19 01 12 No 27.54 mentioned in 19 01 11 D5 M Weighed Offsite in Ireland Landfill),W0146-03 Meath,.,Ireland
Veolia Environmental Revatech

Services Technical Solutions SA,DDT35/KJ/MV,Zoning Zoning
Limited,EPA Waste Licence Corrin,Fermoy,County Industriel,Ehein,Engis,B- Industriel,Ehein,Engis,B-
To Other Countries 19 01 13 Yes 30.598 fly ash containing dangerous substances R5 M Weighed Abroad Number W0050-2 Cork,.,Ireland 4480,Belgium 4480,Belgium
Cork Metal Company
Within the Country 19 12 02 No 1.5 ferrous metal R4 M Weighed Offsite in Ireland 589-01 Dublin Hill, ,Cork, ,Ireland
Rehab Recycle,Cork County
Council Waste Permit Monahan Road, ,Cork ,
Within the Country 20 01 02 No 13.74 glass R5 M Weighed Offsite in Ireland Number 08/04 ,Ireland
Greenstar Environmental
Services Limited,EPA Waste Forge Hill,Kinsale
Within the Country 20 01 08 No 16.95 biodegradable kitchen and canteen waste R3 M Weighed Offsite in Ireland Permit Number W0173-01 Road,Cork, ,Ireland

Waste
Sava
To Other Countries 20 01 14 Yes 0.946 acids D10 M Weighed Abroad Number W0050-2 Cork,.,Ireland many 541,Germany

Limited,Recycling
Services Technical Solutions 003438,Cappincur Industrial Cappincur Industrial
fluorescent tubes and other mercury- Limited,EPA Waste Licence Corrin,Fermoy,County Estate,Daingean Estate,Daingean
Within the Country 20 01 21 Yes 0.232 containing waste R4 M Weighed Offsite in Ireland Number W0050-2 Cork,.,Ireland Road,County Offaly, ,Ireland Road,County Offaly, ,Ireland
Irish Lamp Recycling
Company Limited,Kildare
Irish Lamp Recycling County Council Permit
Company Limited,Kildare Woodstock Industrial Number WFP-KE-08-0384-
County Council Permit Estate,Kilkenny 01,Kilkenny
fluorescent tubes and other mercury- Number WFP-KE-08-0384- Road,Athy,County Road,Athy,County Kildare, Kilkenny Road,Athy,County
Within the Country 20 01 21 Yes 0.344 containing waste R5 M Weighed Offsite in Ireland 01 Kildare,Ireland ,Ireland Kildare, ,Ireland
Sava
paint, inks, adhesives and resins containing Limited,EPA Waste Licence Corrin,Fermoy,County ute,1,Brunsbuttel,25541,Ger Osterweute,1,Brunsbuttel,25
Holcim
Veolia Environmental Belgique,38.152.BP,Rue de
Services Technical Solutions Courriere,Z.I.B de Rue de Courriere,Z.I.B de
Limited,EPA Waste Licence Corrin,Fermoy,County Feluy,Seneffe,B- Feluy,Seneffe,B-
To Other Countries 07 05 01 Yes 90.674 aqueous washing liquids and mother liquors R2 M Weighed Abroad Number W0050-2 Cork,.,Ireland 7181,Belgium 7181,Belgium
Holcim
other organic solvents, washing liquids and Limited,EPA Waste Licence Corrin,Fermoy,County Feluy,Seneffe,B- Feluy,Seneffe,B-
To Other Countries 07 05 04 Yes 244.62 mother liquors R2 M Weighed Abroad Number W0050-2 Cork,.,Ireland 7181,Belgium 7181,Belgium
Veolia Environmental Veolia ES

Services Technical Solutions Garston,FP3133GL,King King
other organic solvents, washing liquids and Limited,EPA Waste Licence Corrin,Fermoy,County Street,Garston,Liverpool,L19 Street,Garston,Liverpool,L19
To Other Countries 07 05 04 Yes 32.56 mother liquors R2 M Weighed Abroad Number W0050-2 Cork,.,Ireland 8EG,United Kingdom 8EG,United Kingdom

Limited,EPA Waste Licence Corrin,Fermoy,County npark Tewnte 243,.,.,7602 243,.,.,7602
To Other Countries 06 01 06 Yes 0.609 other acids D10 M Weighed Abroad Number W0050-2 Cork,.,Ireland Almelo,Netherlands Almelo,Netherlands
Sava
organic halogenated solvents, washing Limited,EPA Waste Licence Corrin,Fermoy,County ute,1,Brunsbuttel,25541,Ger Osterweute,1,Brunsbuttel,25
To Other Countries 07 05 03 Yes 2.396 liquids and mother liquors D10 M Weighed Abroad Number W0050-2 Cork,.,Ireland many 541,Germany

Waste
Services (UK)
gases in pressure containers (including Limited,EPA Waste Licence Corrin,Fermoy,County Wirral,CH65 4EQ,United Port,South Wirral,CH65
To Other Countries 16 05 04 Yes 0.173 halons) containing dangerous substances D10 M Weighed Abroad Number W0050-2 Cork,.,Ireland Kingdom 4EQ,United Kingdom
Services (UK)
discarded inorganic chemicals consisting of Limited,EPA Waste Licence Corrin,Fermoy,County Wirral,CH65 4EQ,United Port,South Wirral,CH65
To Other Countries 16 05 07 Yes 0.01 or containing dangerous substances D10 M Weighed Abroad Number W0050-2 Cork,.,Ireland Kingdom 4EQ,United Kingdom
Enva Ireland Limited,W0041-

Smithstown Industrial 01,Smithstown Industrial Smithstown Industrial
Enva Ireland Limited,W0041- Estate,Shannon,County Estate,Shannon,County Estate,Shannon,County
Within the Country 07 05 01 Yes 771.14 aqueous washing liquids and mother liquors D9 M Weighed Offsite in Ireland 01 Clare, ,Ireland Clare, ,Ireland Clare, ,Ireland
absorbents, filter materials, wiping cloths
and protective clothing other than those Greenstar Limerick,W0082- Ballykeefe Townland,Dock
Within the Country 15 02 03 No 2.92 mentioned in 15 02 02 R12 M Weighed Offsite in Ireland 02 Road,Limerick, ,Ireland
linings and refractories from non- Greenstar Environmental

metallurgical processes other than those Services Limited,EPA Waste Forge Hill,Kinsale
Within the Country 16 11 06 No 4.64 mentioned in 16 11 05 D5 M Weighed Offsite in Ireland Permit Number W0173-01 Road,Cork, ,Ireland
Roadstone Wood Limited. C Belgard

bituminous mixtures containing other than +D Recycling Facility.,WFP- Quarry,Fortunestown,Tallag
Within the Country 17 03 02 No 407.06 those mentioned in 17 03 01 R5 M Weighed Offsite in Ireland DS-11-0005-01 h,Dublin 24,Ireland
Cork Metal Company
Within the Country 02 01 10 No 3.12 waste metal R4 M Weighed Offsite in Ireland 589-01 Dublin Hill, ,Cork, ,Ireland
discarded equipment containing hazardous County Council Permit Estate,Kilkenny 01,Kilkenny
components (16) other than those Number WFP-KE-08-0384- Road,Athy,County Road,Athy,County Kildare, Kilkenny Road,Athy,County
Within the Country 16 02 13 Yes 6.87 mentioned in 16 02 09 to 16 02 12 R4 M Weighed Offsite in Ireland 01 Kildare,Ireland ,Ireland Kildare, ,Ireland

Limited,Recycling
Certification Number RC-
KMK Metals Recycling Cappincur Industrial 003438,Cappincur Industrial Cappincur Industrial
discarded equipment containing Limited,Recycling Estate,Daingean Estate,Daingean Estate,Daingean
Within the Country 16 02 11 Yes 0.576 chlorofluorocarbons, HCFC, HFC R4 M Weighed Offsite in Ireland Certification Number 014904 Road,County Offaly,.,Ireland Road,County Offaly, ,Ireland Road,County Offaly, ,Ireland
KMK Metals Recycling Cappincur Industrial

discarded equipment other than those Limited,Recycling Estate,Daingean
Within the Country 16 02 14 No 0.494 mentioned in 16 02 09 to 16 02 13 R4 M Weighed Offsite in Ireland Certification Number 014904 Road,County Offaly,.,Ireland
components removed from discarded KMK Metals Recycling Cappincur Industrial

equipment other than those mentioned in Limited,Recycling Estate,Daingean
Within the Country 16 02 16 No 1.074 16 02 15 R4 M Weighed Offsite in Ireland Certification Number 014904 Road,County Offaly,.,Ireland

Waste

Within the Country 15 01 06 No 65.168 mixed packaging R1 M Weighed Offsite in Ireland W0136-03 Cork,Ireland
Within the Country 15 01 06 No 16.292 mixed packaging D5 M Weighed Offsite in Ireland W0136-03 Cork,Ireland
* Select a row by double-clicking the Description of Waste then click the delete button
Link to previous years waste data

Link to previous years waste summary data & percentage change
Link to Waste Guidance
Attachment Number 2
2013 AER Waste Data Analysis
Haz Waste : Name and Licence/Permit

Quantity No of Next Destination Facility Haz Waste : Address of Next Destination Name and License / Permit No. and Actual Address of Final Destination i.e.
(Tonnes per Non Haz Waste: Name and Facility Non Haz Waste: Address of Final Recoverer / Disposer Final Recovery / Disposal Site
Year) Method Used Licence/Permit No of Recover/Disposer Address of Recover/Disposer (HAZARDOUS WASTE ONLY) (HAZARDOUS WASTE ONLY)
Waste
Treatment Location of
Transfer Destination European Waste Code Hazardous Quantity T/Year
Limited,IPPCL Register Number Ringaskiddy,County Cork, ,
Within the Country 15 01 02 No 0.14728 plastic packaging D10 M Weighed Onsite of generation P0006-03 ,Ireland
Within the Country 15 01 03 No 0.03252 wooden packaging D10 M Weighed Onsite of generation P0006-03 ,Ireland
Within the Country 15 01 06 No 0.45072 mixed packaging D10 M Weighed Onsite of generation P0006-03 ,Ireland
absorbents, filter materials, wiping cloths and Novartis Ringaskiddy
protective clothing other than those mentioned in Limited,IPPCL Register Number Ringaskiddy,County Cork, ,
Within the Country 15 02 03 No 1.44815 15 02 02 D10 M Weighed Onsite of generation P0006-03 ,Ireland
Veolia Environmental Services
Technical Solutions
bottom ash and slag other than those mentioned Limited,EPA Waste Licence Corrin,Fermoy,County
Within the Country 19 01 12 No 1.92 in 19 01 11 D14 M Weighed Offsite in Ireland Number W0050-2 Cork,.,Ireland
Churchfield Industrial
mixture of concrete, bricks, tiles and ceramics Ashgrove Recycling,EPA Waste Estate,John F. Connolly
Within the Country 17 01 07 No 72.48 other than those mentioned in 17 01 06 D5 M Weighed Offsite in Ireland Licence Number W0147-01 Road,Cork, ,Ireland
bottom ash and slag other than those mentioned (Knockharley Landfill),W0146- Knockharley,Navan,County
Within the Country 19 01 12 No 27.54 in 19 01 11 D5 M Weighed Offsite in Ireland 03 Meath,.,Ireland
linings and refractories from non-metallurgical Greenstar Environmental
processes other than those mentioned in 16 11 Services Limited,EPA Waste Forge Hill,Kinsale Road,Cork,
Within the Country 16 11 06 No 4.64 05 D5 M Weighed Offsite in Ireland Permit Number W0173-01 ,Ireland
Sarsfieldcourt Industrial
Greenstar Recycling (Munster) Estate,Sarsfield
Limited,EPA Waste Permit Court,Glanmire,County
Within the Country 15 01 06 No 16.292 mixed packaging D5 M Weighed Offsite in Ireland Number W0136-03 Cork,Ireland
Sub-total non-hazardous waste disposed: 124.95067

Waste
ERAS ECO Limited,EPA Waste

sludges from on-site effluent treatment other Licence Permit Number W0211- Foxhole,Youghal,County Cork,
Within the Country 07 05 12 No 745.26 than those mentioned in 07 05 11 R1 M Weighed Offsite in Ireland 01 ,Ireland
Within the Country 15 01 06 No 65.168 mixed packaging R1 M Weighed Offsite in Ireland Number W0136-03 Cork,Ireland
absorbents, filter materials, wiping cloths and
protective clothing other than those mentioned in Ballykeefe Townland,Dock
Within the Country 15 02 03 No 2.92 15 02 02 R12 M Weighed Offsite in Ireland Limerick,W0082-02
Greenstar Recycling (Munster) Road,Limerick,Industrial
Sarsfieldcourt ,Ireland
Within the Country 15 01 01 No 60.26 paper and cardboard packaging R3 M Weighed Offsite in Ireland Limited,EPA Waste Permit Estate,Sarsfield
Technical Solutions
Within the Country 15 01 03 No 39.602 wooden packaging R3 M Weighed Offsite in Ireland Number W0136-03 Cork,Ireland
G. Keohane Pallets Recycling Kilnap,Old Mallow Road,Cork,
Within the Country 15 01 03 No 51.84 wooden packaging R3 M Weighed Offsite in Ireland Limited,WCP-CK-08-2570-01 ,Ireland
(Fermoy) Limited,EPA Waste Cullenagh,Fermoy,County Cork,
Within the Country 15 01 03 No 33.38 wooden packaging R3 M Weighed Offsite in Ireland Licence Number W0107-3 ,Ireland
Services Limited,EPA Waste Forge Hill,Kinsale Road,Cork,
Within the Country 20 01 08 No 16.95 biodegradable kitchen and canteen waste R3 M Weighed Offsite in Ireland Permit Number W0173-01 ,Ireland
Cork Metal Company Limited
(Clearcircle
(Clearcircle
(Clearcircle
Within the Country 17 04 11 No 4.4 cables other than those mentioned in 17 04 10 R4 M Weighed Offsite in Ireland 589-01 Dublin Hill, ,Cork, ,Ireland
(Clearcircle
(Clearcircle
discarded equipment other than those mentioned Limited,Recycling Certification Estate,Daingean Road,County
Within the Country 16 02 14 No 0.494 in 16 02 09 to 16 02 13 R4 M Weighed Offsite in Ireland Number 014904 Offaly,.,Ireland
components removed from discarded equipment Limited,Recycling Certification Estate,Daingean Road,County
Within the Country 16 02 16 No 1.074 other than those mentioned in 16 02 15 R4 M Weighed Offsite in Ireland Number 014904 Offaly,.,Ireland
absorbents, filter materials, wiping cloths and Technical Solutions
protective clothing other than those mentioned in Limited,EPA Waste Licence Corrin,Fermoy,County
Within the Country 15 02 03 No 431.24 15 02 02 R5 M Weighed Offsite in Ireland Number W0050-2 Cork,.,Ireland
Council Waste Permit Number
Within the Country 20 01 02 No 13.74 glass R5 M Weighed Offsite in Ireland 08/04 Monahan Road, ,Cork , ,Ireland
Roadstone Wood Limited. C +D Belgard
bituminous mixtures containing other than those Recycling Facility.,WFP-DS-11- Quarry,Fortunestown,Tallagh,D
Within the Country 17 03 02 No 407.06 mentioned in 17 03 01 R5 M Weighed Offsite in Ireland 0005-01 ublin 24,Ireland
Sub-total non-hazardous waste recovered: 2076.349

Waste
Sava
Veolia Environmental Services Sonderabfallverbrennungsanlag
Technical Solutions en
Limited,EPA Waste Licence Corrin,Fermoy,County GmbH,A51G00508,Osterweute, Osterweute,1,Brunsbuttel,25541
To Other Countries 06 02 05 Yes 0.033 other bases D10 M Weighed Abroad Number W0050-2 Cork,.,Ireland 1,Brunsbuttel,25541,Germany ,Germany
Novartis Ringaskiddy Limited,IPPCL Register Number
Limited,IPPCL Register Number Ringaskiddy,County Cork, , P0006-03,Ringaskiddy,County Ringaskiddy,County
Within the Country 07 05 01 Yes 359.221 aqueous washing liquids and mother liquors D10 C Volume Calculation Onsite of generation P0006-03 ,Ireland Cork,.,.,Ireland Cork,.,.,Ireland

Veolia Environmental Services (UK) Limited,BS51931E,Bridges
Technical Solutions Road,Ellesmere Port,South Bridges Road,Ellesmere
Sava
To Other Countries 07 05 01 Yes 28.046 aqueous washing liquids and mother liquors D10 M Weighed Abroad Number W0050-2 Cork,.,Ireland 1,Brunsbuttel,25541,Germany ,Germany
Sava
other organic solvents, washing liquids and Limited,EPA Waste Licence Corrin,Fermoy,County GmbH,A51G00508,Osterweute, Osterweute,1,Brunsbuttel,25541
To Other Countries 07 05 04 Yes 21.545 mother liquors D10 M Weighed Abroad Number W0050-2 Cork,.,Ireland 1,Brunsbuttel,25541,Germany ,Germany
Within the Country 07 05 10 Yes 0.3631 other filter cakes and spent absorbents D10 M Weighed Onsite of generation P0006-03 ,Ireland Cork,.,.,Ireland Cork,.,.,Ireland
Sava
To Other Countries 07 05 10 Yes 40.537 other filter cakes and spent absorbents D10 M Weighed Abroad Number W0050-2 Cork,.,Ireland 1,Brunsbuttel,25541,Germany ,Germany
Within the Country 07 05 13 Yes 2.55587 solid wastes containing dangerous substances D10 M Weighed Onsite of generation P0006-03
Veolia Environmental Services ,Ireland
Corrin,Fermoy,County Cork,.,.,Ireland
Sava Cork,.,.,Ireland
Osterweute,1,Brunsbuttel,25541
To Other Countries 07 05 13 Yes 13.184 solid wastes containing dangerous substances D10 M Weighed Abroad Technical Solutions Cork,.,Ireland Sonderabfallverbrennungsanlag ,Germany
packaging containing residues of or Limited,IPPCL Register Number Ringaskiddy,County Cork, , P0006-03,Ringaskiddy,County Ringaskiddy,County
Within the Country 15 01 10 Yes 28.39577 contaminated by dangerous substances D10 M Weighed Onsite of generation P0006-03 ,Ireland Cork,.,.,Ireland Cork,.,.,Ireland
Sava
packaging containing residues of or Limited,EPA Waste Licence Corrin,Fermoy,County GmbH,A51G00508,Osterweute, Osterweute,1,Brunsbuttel,25541
To Other Countries 15 01 10 Yes 29.151 contaminated by dangerous substances D10 M Weighed Abroad Number W0050-2 Cork,.,Ireland 1,Brunsbuttel,25541,Germany ,Germany

absorbents, filter materials (including oil filters Novartis Ringaskiddy Limited,IPPCL Register Number
not otherwise specified), wiping cloths, protective Limited,IPPCL Register Number Ringaskiddy,County Cork, , P0006-03,Ringaskiddy,County Ringaskiddy,County
Within the Country 15 02 02 Yes 29.02006 clothing contaminated by dangerous substances D10 M Weighed Onsite of generation P0006-03 ,Ireland Cork,.,.,Ireland Cork,.,.,Ireland
Sava
absorbents, filter materials (including oil filters Technical Solutions en
not otherwise specified), wiping cloths, protective Limited,EPA Waste Licence Corrin,Fermoy,County GmbH,A51G00508,Osterweute, Osterweute,1,Brunsbuttel,25541
To Other Countries 15 02 02 Yes 21.781 clothing contaminated by dangerous substances D10 M Weighed Abroad Number W0050-2 Cork,.,Ireland 1,Brunsbuttel,25541,Germany ,Germany
Within the Country 16 03 05 Yes 0.00491 organic wastes containing dangerous substances D10 M Weighed Onsite of generation P0006-03 ,Ireland Cork,.,.,Ireland Cork,.,.,Ireland
Tradebe Fawley
Veolia Environmental Services Limited,ERP/FP3935KL,Charlst
Technical Solutions on Charlston
gases in pressure containers (including halons) Limited,EPA Waste Licence Corrin,Fermoy,County Road,Hardley,Southampton,SO Road,Hardley,Southampton,SO
To Other Countries 16 05 04 Yes 0.037 containing dangerous substances D10 M Weighed Abroad Number W0050-2 Cork,.,Ireland 45 3ZA,United Kingdom 45 3ZA,United Kingdom
laboratory chemicals, consisting of or containing Novartis Ringaskiddy Limited,IPPCL Register Number
dangerous substances, including mixtures of Limited,IPPCL Register Number Ringaskiddy,County Cork, , P0006-03,Ringaskiddy,County Ringaskiddy,County
Within the Country 16 05 06 Yes 13.06746 laboratory chemicals D10 M Weighed Onsite of generation P0006-03 ,Ireland Cork,.,.,Ireland Cork,.,.,Ireland
Sava
laboratory chemicals, consisting of or containing Technical Solutions en
dangerous substances, including mixtures of Limited,EPA Waste Licence Corrin,Fermoy,County GmbH,A51G00508,Osterweute, Osterweute,1,Brunsbuttel,25541
To Other Countries 16 05 06 Yes 0.024 laboratory chemicals D10 M Weighed Abroad Number W0050-2 Cork,.,Ireland 1,Brunsbuttel,25541,Germany ,Germany
Sava
discarded inorganic chemicals consisting of or Limited,EPA Waste Licence Corrin,Fermoy,County GmbH,A51G00508,Osterweute, Osterweute,1,Brunsbuttel,25541
To Other Countries 16 05 07 Yes 5.68 containing dangerous substances D10 M Weighed Abroad Number W0050-2 Cork,.,Ireland 1,Brunsbuttel,25541,Germany ,Germany
Sava
discarded organic chemicals consisting of or Limited,EPA Waste Licence Corrin,Fermoy,County GmbH,A51G00508,Osterweute, Osterweute,1,Brunsbuttel,25541
To Other Countries 16 05 08 Yes 1.133 containing dangerous substances D10 M Weighed Abroad Number W0050-2 Cork,.,Ireland 1,Brunsbuttel,25541,Germany ,Germany
Sava
To Other Countries 20 01 14 Yes 0.946 acids D10 M Weighed Abroad Number W0050-2 Cork,.,Ireland 1,Brunsbuttel,25541,Germany ,Germany
Sava
paint, inks, adhesives and resins containing Limited,EPA Waste Licence Corrin,Fermoy,County GmbH,A51G00508,Osterweute, Osterweute,1,Brunsbuttel,25541
To Other Countries 20 01 27 Yes 2.414 dangerous substances D10 M Weighed Abroad Number W0050-2 Cork,.,Ireland 1,Brunsbuttel,25541,Germany ,Germany
Veolia Environmental Services SITA Ecoservices Treatment
Technical Solutions BV,EMT/2008/2694,Bedrijvenpa
Limited,EPA Waste Licence Corrin,Fermoy,County rk Tewnte 243,.,.,7602 Bedrijvenpark Tewnte
To Other Countries 06 01 06 Yes 0.609 other acids D10 M Weighed Abroad Number W0050-2 Cork,.,Ireland Almelo,Netherlands 243,.,.,7602 Almelo,Netherlands
Sava
organic halogenated solvents, washing liquids Limited,EPA Waste Licence Corrin,Fermoy,County GmbH,A51G00508,Osterweute, Osterweute,1,Brunsbuttel,25541
To Other Countries 07 05 03 Yes 2.396 and mother liquors D10 M Weighed Abroad Number W0050-2 Cork,.,Ireland 1,Brunsbuttel,25541,Germany ,Germany

gases in pressure containers (including halons) Limited,EPA Waste Licence Corrin,Fermoy,County Wirral,CH65 4EQ,United Port,South Wirral,CH65
To Other Countries 16 05 04 Yes 0.173 containing dangerous substances D10 M Weighed Abroad Number W0050-2 Cork,.,Ireland Kingdom 4EQ,United Kingdom

discarded inorganic chemicals consisting of or Limited,EPA Waste Licence Corrin,Fermoy,County Wirral,CH65 4EQ,United Port,South Wirral,CH65
To Other Countries 16 05 07 Yes 0.01 containing dangerous substances D10 M Weighed Abroad Number W0050-2 Cork,.,Ireland Kingdom 4EQ,United Kingdom
other organic solvents, washing liquids and Limited,IPPCL Register Number Ringaskiddy,County Cork, , P0006-03,Ringaskiddy,County Ringaskiddy,County
Within the Country 07 05 04 Yes 249.208 mother liquors D8 E Volume Calculation Onsite of generation P0006-03 ,Ireland Cork,.,.,Ireland Cork,.,.,Ireland
Estate,Shannon,County Clare, Estate,Shannon,County Clare, Estate,Shannon,County Clare,
Within the Country 07 05 01 Yes 771.14 aqueous washing liquids and mother liquors D9 M Weighed Offsite in Ireland Enva Ireland Limited,W0041-01 ,Ireland ,Ireland ,Ireland
Sub-total hazardous waste disposed: 2364.74417

Waste
Veolia Environmental Services Veolia Sotrenor,DCVC-EIM-FT

Technical Solutions n 2005-195,Route
Limited,EPA Waste Licence Corrin,Fermoy,County d'Harnes,62,Courrieres ,FR Route d'Harnes,62,Courrieres
To Other Countries 07 05 01 Yes 1901.675 aqueous washing liquids and mother liquors R1 M Weighed Abroad Number W0050-2 Cork,.,Ireland 62710,France ,FR 62710,France
Within the Country 07 05 04 Yes 1984.747 mother liquors R1 C Volume Calculation Onsite of generation P0006-03 ,Ireland Cork,.,.,Ireland Cork,.,.,Ireland
other organic solvents, washing liquids and Limited,IPPCL Register Number Ringaskiddy,County Cork, , P0006-03,Ringaskiddy, ,County Ringaskiddy, ,County Cork,
Within the Country 07 05 04 Yes 372.119 mother liquors R1 C Volume Calculation Onsite of generation P0006-03 ,Ireland Cork, ,Ireland ,Ireland
Veolia Environmental Services Lagan Cement Limited,IPPCL
Technical Solutions P0487-
Limited,EPA Waste Licence Corrin,Fermoy,County 06,Killaskillen,Kinnegad,County Killaskillen,Kinnegad,County
Within the Country 07 05 01 Yes 1722.816 aqueous washing liquids and mother liquors R2 M Weighed Offsite in Ireland Number W0050-2 Cork,.,Ireland Meath,MEATH,Ireland Meath,MEATH,Ireland
Within the Country 07 05 04 Yes 4366.5 mother liquors R2 C Volume Calculation Onsite of generation P0006-03 ,Ireland Cork,.,.,Ireland Cork,.,.,Ireland
Veolia Environmental Services Lagan Cement Limited,IPPCL
Technical Solutions P0487-
other organic solvents, washing liquids and Limited,EPA Waste Licence Corrin,Fermoy,County 06,Killaskillen,Kinnegad,County Killaskillen,Kinnegad,County
Within the Country 07 05 04 Yes 4647.786 mother liquors R2 M Weighed Offsite in Ireland Number W0050-2 Cork,.,Ireland Meath,MEATH,Ireland Meath,MEATH,Ireland
MP Storage and
Veolia Environmental Services Blending,WML60102,Deep
Technical Solutions Water Wharf,Cargo Deep Water Wharf,Cargo
Veolia Environmental Services SITA Ecoservices Treatment
Technical Solutions BV,EMT/2008/2694,Bedrijvenpa
other organic solvents, washing liquids and Limited,EPA Waste Licence Corrin,Fermoy,County rk Tewnte 243,.,.,7602 Bedrijvenpark Tewnte
To Other Countries 07 05 04 Yes 62.02 mother liquors R2 M Weighed Abroad Number W0050-2 Cork,.,Ireland Almelo,Netherlands 243,.,.,7602 Almelo,Netherlands
Technical Solutions Holcim Belgique,38.152.BP,Rue
Limited,EPA Waste Licence Corrin,Fermoy,County de Courriere,Z.I.B de Rue de Courriere,Z.I.B de
To Other Countries 07 05 01 Yes 90.674 aqueous washing liquids and mother liquors R2 M Weighed Abroad Number W0050-2 Cork,.,Ireland Feluy,Seneffe,B-7181,Belgium Feluy,Seneffe,B-7181,Belgium
Technical Solutions Holcim Belgique,38.152.BP,Rue
other organic solvents, washing liquids and Limited,EPA Waste Licence Corrin,Fermoy,County de Courriere,Z.I.B de Rue de Courriere,Z.I.B de
To Other Countries 07 05 04 Yes 244.62 mother liquors R2 M Weighed Abroad Number W0050-2 Cork,.,Ireland Feluy,Seneffe,B-7181,Belgium Feluy,Seneffe,B-7181,Belgium
Veolia Environmental Services Veolia ES
Technical Solutions Garston,FP3133GL,King King
Technical Solutions Limited,EPA Waste Licence
Within the Country 15 01 10 Yes 1.283 contaminated by dangerous
discarded equipment substances
containing hazardous R4 M Weighed Offsite in Ireland Number W0050-2
Veolia Environmental Services Cork,.,Ireland
Corrin,Fermoy,County ,Fermoy,County Cork,Ireland
KMK Metals Recycling Cork,Ireland
Cappincur Industrial
Within the Country 16 02 13 Yes 1.537 components (16) other than those mentioned in R4 M Weighed Offsite in Ireland Technical Solutions Cork,.,Ireland Limited,Recycling Certification Estate,Daingean Road,County
Rilta Environmental
Rilta Environmental Grants Drive,Block W0192-03,Grants Drive,Block Grants Drive,Block
Limited,EPA Waste Licence 402,Greenogue Business 402,Greenogue Business 402,Greenogue Business
Veolia Environmental Services Limited,Recycling Certification
Technical Solutions Number RC-003438,Cappincur Cappincur Industrial
fluorescent tubes and other mercury-containing Limited,EPA Waste Licence Corrin,Fermoy,County Industrial Estate,Daingean Estate,Daingean Road,County
Within the Country 20 01 21 Yes 0.232 waste R4 M Weighed Offsite in Ireland Number W0050-2 Cork,.,Ireland Road,County Offaly, ,Ireland Offaly, ,Ireland
Irish Lamp Recycling Company
Limited,Kildare County Council
Irish Lamp Recycling Company Woodstock Industrial Permit Number WFP-KE-08-
discarded equipment containing hazardous Limited,Kildare County Council Estate,Kilkenny 0384-01,Kilkenny
components (16) other than those mentioned in Permit Number WFP-KE-08- Road,Athy,County Road,Athy,County Kildare, Kilkenny Road,Athy,County
Within the Country 16 02 13 Yes 6.87 16 02 09 to 16 02 12 R4 M Weighed Offsite in Ireland 0384-01 Kildare,Ireland ,Ireland Kildare, ,Ireland
Limited,Recycling Certification
KMK Metals Recycling Cappincur Industrial Number RC-003438,Cappincur Cappincur Industrial
discarded equipment containing Limited,Recycling Certification Estate,Daingean Road,County Industrial Estate,Daingean Estate,Daingean Road,County
Within the Country 16 02 11 Yes 0.576 chlorofluorocarbons, HCFC, HFC R4 M Weighed Offsite in Ireland Number 014904 Offaly,.,Ireland Road,County Offaly, ,Ireland Offaly, ,Ireland
Veolia Environmental Services Revatech
Technical Solutions SA,DDT35/KJ/MV,Zoning
Limited,EPA Waste Licence Corrin,Fermoy,County Industriel,Ehein,Engis,B- Zoning Industriel,Ehein,Engis,B-
Irish Lamp Recycling Company
Limited,Kildare County Council
Irish Lamp Recycling Company Woodstock Industrial Permit Number WFP-KE-08-
Limited,Kildare County Council Estate,Kilkenny 0384-01,Kilkenny
fluorescent tubes and other mercury-containing Permit Number WFP-KE-08- Road,Athy,County Road,Athy,County Kildare, Kilkenny Road,Athy,County
Within the Country 20 01 21 Yes 0.344 waste R5 M Weighed Offsite in Ireland 0384-01 Kildare,Ireland ,Ireland Kildare, ,Ireland
Johnson Matthey
Veolia Environmental Services plc,VP3430BN/PCC/JMP/1
Technical Solutions 1/07,Orchard Orchard
spent catalysts contaminated with dangerous Limited,EPA Waste Licence Corrin,Fermoy,County Road,Royston,Hertfordshire,SG Road,Royston,Hertfordshire,SG
To Other Countries 16 08 07 Yes 10.926 substances R8 M Weighed Abroad Number W0050-2 Cork,.,Ireland 8 5HE,United Kingdom 8 5HE,United Kingdom
Heraeus Precious Metals GmbH
&
Co.,F44RD0069,Heraeusstrasse
spent catalysts contaminated with dangerous Heraeus Precious Metals GmbH Heraeusstrasse 12 - 14,.,.,D- 12 - 14,.,.,D-63450 Heraeusstrasse 12 - 14,.,.,D-
To Other Countries 16 08 07 Yes 84.926 substances R8 M Weighed Abroad & Co.,F44RD0069 63450 Hanau,Germany Hanau,Germany 63450 Hanau,Germany
Sub-total hazardous
waste recovered: 15,959.870
Total non-hazardous
waste: 2,201.300
Total hazardous
waste: 18,324.614
Total waste: 20,525.914

Attachment Number 3
Environmental and Industrial Hygiene Laboratory. Telephone: 021/4862324.
Novartis Ringaskiddy Limited, Fax: 021/4862355.
Ringaskiddy, Co. Cork.
REPORT: DEWATERED AEROBICALLY DIGESTED SLUDGE LEACHATE ANALYSIS
EMISSION POINT REFERENCE NUMBER 100 (WASTEWATER TREATMENT PLANT)
SCHEDULE C.4; INTEGRATED POLLUTION PREVENTION AND CONTROL LICENCE REGISTER

NUMBER P0006-03
REPORTING PERIOD: March, 2013
Schedule C.4 of Integrated Pollution Prevention and Control Licence (IPPCL) Register Number P0006-03 requires that a
leachate test be carried out on dewatered aerobically digested sludge produced as a by-product of effluent treatment. An
analysis for heavy metals (individual), organic matter and water content is required a quarterly basis; and an analysis for
organic compounds is required on an annual basis. Note that this requirement dates from a time when such material was
sent for landfill. This is no longer the case. The sludge is first dried and then subsequently incinerated (with heat
recovery) in suitably licensed facilities.
Novartis Ringaskiddy Limited engaged the services of Environmental Laboratory Services, Acorn Business Campus,
Mahon Industrial Park, Blackrock, Cork, to carry out a distilled water leachate test and some additional tests on a sample
of this material. The leachate method reference method was to the standard ISEN12457-4 2002 10/1.
The following table summarises the analytical results of the eluate from the leachate procedure (single leaching):
________________________________________________________________________________________________
PARAMETER RESULT
________________________________________________________________________________________________
Sampling Date: 26-Mar-2013
Total Organic Carbon: 19 g/kg DW
Zinc: 2 mg/kg DW
Copper: <0.3 mg/kg DW
Dry Matter: 14 %
________________________________________________________________________________________________
NOTE: Neither Copper nor Zinc has been used at Novartis Ringaskiddy Limited up to this point in time.
A subsample of the leachate was analysed by Environmental Laboratory Services for organic compounds. The results of
this analysis are reproduced on the test certificate on the following page.
Signed : Vincent Boyton.
Dated : 03-Jun-2013.
ENVIRONMENTAL
LABORATORY SERVICES
Acorn Business Campus
Mahon Industrial Park,
Blackrock,
Cork
Ireland
Tel: +353 21 453 6141
Fax: +353 21 453 6149
Web: www.irishwatertesting.com
Contact Name Vincent Boyton Report Number 64864 - 1

Address Novartis Ringaskiddy Limited Sample Number 64864/001
IDA Estate, Date of Receipt 27/03/2013
Ringaskiddy, Date Started 27/03/2013
Tel No 021- 4862324 Received or Collected Courier

Fax No Condition on Receipt Good
Customer PO 0P-107629 Date of Report 07/05/2013
Quotation No QN001292 Sample Type Sludge-Solid
Customer Ref NO: 20130515 26/3/13 SOURCE:WWTP SLUDGE
CERTIFICATE OF ANALYSIS
TEST ANALYTE SUB METHOD LOQ SPEC RESULT UNITS ACCRED. OOS
AQ2-UP2 Leachate
Chloride (Leachate-Calc) EW154M 260.00 800 3740.20 mg/kg DW OOS-A
Sulphate (Leachate-Calc) EW154M 100.00 1000 <100.00 mg/kg DW
Dissolved Organic Carbon (DOC)
Dissolved Organic Carbon-Leachate (Calc) EW123 25.00 500 1778.67 mg/kg DW OOS-A
Extraction -Organics (Solids)
Extraction -Organics (Solids) GLP027 Yes
GCMS-Polynucleur Aromatic Hydrocarbons (PAH)
Naphthalene (Solid sample) EO129 0.100 <0.100 mg/kg DW
Acenaphthylene (Solid sample) EO129 0.100 <0.100 mg/kg DW
Acenaphtene (Solid sample) EO129 0.100 <0.100 mg/kg DW
Fluorene (Solid sample) EO129 0.100 <0.100 mg/kg DW
Phenanthrene (Solid sample) EO129 0.100 <0.100 mg/kg DW
Anthracene (Solid sample) EO129 0.100 <0.100 mg/kg DW
Fluoranthene (Solid sample) EO129 0.100 <0.100 mg/kg DW
Pyrene (Solid sample) EO129 0.100 <0.100 mg/kg DW
Chrysene (Solid sample) EO129 0.100 <0.100 mg/kg DW
Dibenzo(a,h)anthracene (Solid sample) EO129 0.100 <0.100 mg/kg DW
Benzo(a)-pyrene (Solid sample) EO129 0.100 <0.100 mg/kg DW
Benzo (b)-Fluoranthene (Solid sample) EO129 0.100 <0.100 mg/kg DW
Benzo (k)-Fluoranthene (Solid sample) EO129 0.100 <0.100 mg/kg DW
Benzo (g,h,i)-Perylene (Solid sample) EO129 0.100 <0.100 mg/kg DW
Indeno(1, 2, 3-c, d)pyrene (Solid sample) EO129 0.100 <0.100 mg/kg DW
Benzo(a)-anthracene (Solid sample) EO129 0.100 <0.100 mg/kg DW
Ion Chromatography
Flouride Leachate (Calc) EW137 4.00 10 8.36 mg/kg DW
Leaching Per ISEN12457-4 2002- 10/1
Dry Weight Sample used (Wet Wt * Solids%) GLP027 0.000 0.034 kg
Sample Volume ( litres) GLP027 0.00 0.35 L
Metals-Leachate
Arsenic-Total (Leachate) EM130 0.020 0.5 <0.020 mg/kg DW
Barium-Total (Leachate) EM130 0.100 20 1.289 mg/kg DW
Cadmium-Total (Leachate) EM130 0.010 0.04 <0.010 mg/kg DW
Chromium-Total (Leachate) EM130 0.100 0.5 <0.100 mg/kg DW
Mercury-Total (Leachate) EM130 0.002 0.01 <0.002 mg/kg DW
Molybdenum-Total (Leachate) EM130 0.100 0.5 0.107 mg/kg DW
Signed : 07/05/2013
Technical Manager (or Deputy): Sinead Murray

NOTES
1.This Report shall not be Reproduced except in full, without the permission of the laboratory and only relates to the items tested.
2.SPEC= Allowable limit or parametric value
3.OOS=Result which is outside specification highlighted as OOS
4.LOQ=Limit of Quantification or lowest value that can be reported for the test
5.ACCRED=Indicates matrix accreditation for the test,a blank field indicates not accredited
Page 1 of 2
ENVIRONMENTAL
LABORATORY SERVICES
Blackrock,
Cork
Ireland
Tel: +353 21 453 6141
Fax: +353 21 453 6149

Tel No 021- 4862324 Received or Collected Courier

Customer PO 0P-107629 Date of Report 07/05/2013
Customer Ref NO: 20130515 26/3/13 SOURCE:WWTP SLUDGE
Metals-Leachate
Nickel-Total (Leachate) EM130 0.050 0.4 0.124 mg/kg DW
Lead-Total (Leachate) EM130 0.030 0.5 <0.030 mg/kg DW
Antimony-Total (Leachate) EM130 0.010 0.06 <0.010 mg/kg DW
Selenium-Total (Leachate) EM130 0.020 0.1 <0.020 mg/kg DW
Zinc-Total (Leachate) EM130 0.100 4 1.629 mg/kg DW
Copper-Total (Leachate) EM130 0.300 2 <0.300 mg/kg DW
Organic Matter (Sub)
TOC-Organic Matter-Solid- (Convert to mg/kg * Default 1.0 30000 19000.0 mg/kg DW YES
Sub)
PCBs (Sub)
PCB 101 (Solid sample) * Default 0.100 <0.100 mg/kg DW
PCB Total (Solid sample) * Default 0.100 1 <0.100 mg/kg DW
PhenolsTotal -Index (Sub1)
Phenols-Total (Leachate) (Convert to mg/kg) * Default 1.50 1 <1.50 mg/kg DW
Solids Content (Solid Samples)
Solids Content (Solid Samples) EM113 1.0 14.1 % w/w
Total Dissolved Solids (TDS)
Total Dissolved Solids -Leachate (Calc) EW046 1500.00 4000 6062.58 mg/kg DW OOS-A
TPH Spec. 3 (Sub)
EH >C6-C40 (Mineral Oil) (Solid sample) * Default 50.00 500 <50.00 mg/kg DW YES
VOC-BTEX
Total BTEX (Calc) (Solid sample) EO025 0.1 6 <0.1 mg/kg DW
Benzene (Solid sample) EO025 0.1 <0.1 mg/kg DW
Toluene (Solid sample) EO025 0.1 <0.1 mg/kg DW
Ethylbenzene (Solid sample) EO025 0.1 <0.1 mg/kg DW
Xylene-O (Solid sample) EO025 0.1 <0.1 mg/kg DW
Xylene P&M (Solid sample) EO025 0.1 <0.1 mg/kg DW
Signed : 07/05/2013
Technical Manager (or Deputy): Sinead Murray

NOTES
Page 2 of 2

NUMBER P0006-03
REPORTING PERIOD: June, 2013
________________________________________________________________________________________________
PARAMETER RESULT
________________________________________________________________________________________________
Sampling Date: 25-Jun-2013
Zinc: 1 mg/kg DW
Copper: < 0.3 mg/kg DW
Dry Matter: 17 %
________________________________________________________________________________________________
Dated : 02-Sep-2013.
ENVIRONMENTAL
LABORATORY SERVICES
Blackrock,
Cork
Ireland
Tel: +353 21 453 6141
Fax: +353 21 453 6149

Tel No 021- 4862324 Received or Collected Hand

Fax No Condition on Receipt See Comments
Customer PO OP-112428 Date of Report 26/08/2013
Customer Ref Sample Number: 20131043
AQ2-UP2 Leachate
Chloride (Leachate-Calc) EW154M 260.00 800 2195.56 mg/kg DW OOS-A
Sulphate (Leachate-Calc) EW154M 100.00 1000 2207.94 mg/kg DW OOS-A
Batch-Change Sample Type
Batch-Change Sample Type Default 0 Yes
Ion Chromatography
Flouride Leachate (Calc) EW137 4.00 10 <4.00 mg/kg DW
Metals-Leachate
Arsenic-Total (Leachate) EM130 0.020 0.5 0.046 mg/kg DW
Signed : 26/08/2013
Technical Manager (or Deputy): Brendan Murray

NOTES
Page 1 of 2
ENVIRONMENTAL
LABORATORY SERVICES
Blackrock,
Cork
Ireland
Tel: +353 21 453 6141
Fax: +353 21 453 6149

Tel No 021- 4862324 Received or Collected Hand

Fax No Condition on Receipt See Comments
Customer Ref Sample Number: 20131043
Metals-Leachate
Nickel-Total (Leachate) EM130 0.050 0.4 0.503 mg/kg DW OOS-A
Selenium-Total (Leachate) EM130 0.020 0.1 0.041 mg/kg DW
TOC-Organic Matter-Solid- (Convert to mg/kg * Default 1.0 30000 360000.0 mg/kg DW YES OOS-A
Sub)
PCBs (Sub)
Phenols-Total (Leachate) (Convert to mg/kg) * Default 1.50 1 4.32 mg/kg DW OOS-A
TPH Spec. 3 (Sub)
EH >C6-C40 (Mineral Oil) (Solid sample) * Default 50.00 500 11000.00 mg/kg DW YES OOS-A
VOC-BTEX
Total BTEX (Calc) (Solid sample) EO025 0.1 6 0.7 mg/kg DW
Toluene (Solid sample) EO025 0.1 0.5 mg/kg DW
Xylene-O (Solid sample) EO025 0.1 0.1 mg/kg DW
Xylene P&M (Solid sample) EO025 0.1 0.1 mg/kg DW
Signed : 26/08/2013

NOTES
Page 2 of 2

NUMBER P0006-03
REPORTING PERIOD: October, 2013
________________________________________________________________________________________________
PARAMETER RESULT
________________________________________________________________________________________________
Sampling Date: 01-Oct-2013
Zinc: 1 mg/kg DW
Dry Matter: 7%
________________________________________________________________________________________________
Dated : 17-Dec-2013.
ENVIRONMENTAL
LABORATORY SERVICES
Blackrock,
Cork
Ireland
Tel: +353 21 453 6141
Fax: +353 21 453 6149

Tel No 021- 4862324 Received or Collected ELS-PickUp

Customer Ref Sample Number 20131679 Sludge Cake Source WWTP 01/10/13
AQ2-UP2 Leachate
Chloride (Leachate-Calc) EW154M-1 260.00 800 955.38 mg/kg DW OOS-A
Sulphate (Leachate-Calc) EW154M-1 100.00 1000 408.52 mg/kg DW
Dissolved Organic Carbon-Leachate (Calc) EW123 25.00 500 226.07 mg/kg DW
Ion Chromatography
Metals-Leachate
Arsenic-Total (Leachate) EM130 0.020 0.5 0.023 mg/kg DW
Signed : 14/11/2013

NOTES
Page 1 of 2
ENVIRONMENTAL
LABORATORY SERVICES
Blackrock,
Cork
Ireland
Tel: +353 21 453 6141
Fax: +353 21 453 6149


Customer Ref Sample Number 20131679 Sludge Cake Source WWTP 01/10/13
Metals-Leachate
Nickel-Total (Leachate) EM130 0.050 0.4 <0.050 mg/kg DW
TOC-Organic Matter-Solid- (Convert to mg/kg * Default 1.0 30000 110000.0 mg/kg DW YES OOS-A
Sub)
PCBs (Sub)
TPH Spec. 3 (Sub)
EH >C6-C40 (Mineral Oil) (Solid sample) * Default 50.0 500 600.0 mg/kg DW YES OOS-A
VOC-BTEX
Total BTEX (Calc) (Solid sample) EO025 0.1 6 0.2 mg/kg DW
Xylene-O (Solid sample) EO025 0.1 0.1 mg/kg DW
Signed : 14/11/2013

NOTES
Page 2 of 2

NUMBER P0006-03
REPORTING PERIOD: December, 2013
________________________________________________________________________________________________
PARAMETER RESULT
________________________________________________________________________________________________
Sampling Date: 13-Dec-2013
Zinc: < 1 mg/kg DW
Dry Matter: 11 %
________________________________________________________________________________________________
Dated : 28-Mar-2014.
ENVIRONMENTAL
LABORATORY SERVICES
Blackrock,
Cork
Ireland
Tel: +353 21 453 6141
Fax: +353 21 453 6149


Customer Ref Sludge Cake Sample Number: 20132144 Sampled: 13/12/13
AQ2-UP2 Leachate
Chloride (Leachate-Calc) EW154M-1 260.00 800 4379.39 mg/kg DW OOS-A
Sulphate (Leachate-Calc) EW154M-1 100.00 1000 3714.12 mg/kg DW OOS-A
Ion Chromatography
Metals-Leachate
Arsenic-Total (Leachate) EM130 0.020 0.5 <0.020 mg/kg DW
Barium-Total (Leachate) EM130 0.100 20 <0.100 mg/kg DW
Signed : 20/01/2014

NOTES
5.ACCRED=Indicates matrix accreditation for the test,a blank field indicates not accredited Page 1 of 3
ENVIRONMENTAL
LABORATORY SERVICES
Blackrock,
Cork
Ireland
Tel: +353 21 453 6141
Fax: +353 21 453 6149


Metals-Leachate
Molybdenum-Total (Leachate) EM130 0.100 0.5 <0.100 mg/kg DW
Nickel-Total (Leachate) EM130 0.050 0.4 <0.050 mg/kg DW
Zinc-Total (Leachate) EM130 0.100 4 <0.100 mg/kg DW
TOC-Organic Matter-Solid- (Convert to * Default 1.0 30000 150000.0 mg/kg DW YES OOS-A
mg/kg Sub)
PCBs (Sub)
TPH Spec. 3 (Sub)
EH >C6-C40 (Mineral Oil) (Solid sample) * Default 50.0 500 410.0 mg/kg DW YES
VOC-BTEX
Total BTEX (Calc) (Solid sample) EO025 0.1 6 <0.1 mg/kg DW
Xylene-O (Solid sample) EO025 0.1 <0.1 mg/kg DW
Signed : 20/01/2014

NOTES
ENVIRONMENTAL
LABORATORY SERVICES
Blackrock,
Cork
Ireland
Tel: +353 21 453 6141
Fax: +353 21 453 6149


VOC-BTEX
Signed : 20/01/2014

NOTES
REPORT: DEWATERED AEROBICALLY DIGESTED SLUDGE COMPOSITIONAL ANALYSIS

NUMBER P0006-03
REPORTING PERIOD: October, 2013
Mahon Industrial Park, Blackrock, Cork, to carry out additional compositional analysis on a number of the companys
dewatered aerobically digested sludge produced as a by-product of effluent treatment following a request from the
Environmental Protection Agency.
The certificate on the following summarises the analytical results for a sample than was taken on 01-Oct-2013.
Dated : 17-Dec-2013.
ENVIRONMENTAL
LABORATORY SERVICES
Blackrock,
Cork
Ireland
Tel: +353 21 453 6141
Fax: +353 21 453 6149


Customer Ref Sample Number: 20131679 Sludge Cake Source: WWTP 01/10/13
AQ2-UP2
Chloride EW154M-1 50.0 725.7 mg/kg DW
Sulphate EW154M-1 20.0 263.7 mg/kg DW
Metals-Total
Beryllium-Total EM130 5.0 <5.0 mg/kg DW
Cobalt-Total EM130 5.0 <5.0 mg/kg DW
Molybdenum-Total EM130 5.0 7.4 mg/kg DW
Thallium-Total EM130 5.0 <5.0 mg/kg DW
Vanadium-Total EM130 5.0 <5.0 mg/kg DW
Chromium-Total (Solid) EM130 5.0 27.6 mg/kg DW
Antimony-Total (Solid) EM130 0.5 2.2 mg/kg DW
Arsenic-Total (Solid) EM130 1.0 3.5 mg/kg DW
Cadmium-Total (Solid) EM130 0.5 <0.5 mg/kg DW
Copper-Total (Solid) EM130 5.000 85.134 mg/kg DW
Lead-Total (Solid) EM130 1.5 24.1 mg/kg DW
Mercury-Total (Solid) EM130 0.50 0.75 mg/kg DW
Nickel-Total (Solid) EM130 2.5 17.8 mg/kg DW
Selenium-Total (Solid) EM130 1.0 3.3 mg/kg DW
Barium-Total (Solid) EM130 5.0 48.2 mg/kg DW
Zinc-Total (Solid) EM130 5.0 1053.3 mg/kg DW
SVOC (Sub)(Solid)
2,3,4,6-Tetrachlorophenol * Default 1.0 <1.0 mg/kg
2,4,5-Trichlorophenol * Default 1.0 <1.0 mg/kg
2,4-Dichlorophenol * Default 1.0 <1.0 mg/kg
2,4-Dimethylphenol * Default 1.0 <1.0 mg/kg
2,4-Dinitrophenol * Default 1.0 <1.0 mg/kg
2-Chlorophenol * Default 1.0 <1.0 mg/kg
2-Methyl-4,6-Dinitrophenol * Default 1.0 <1.0 mg/kg
2-Methylphenol * Default 1.0 <1.0 mg/kg
2-Nitrophenol * Default 1.0 <1.0 mg/kg
3&4-Methylphenol * Default 1.0 <1.0 mg/kg
4-Chloro-3-methylphenol * Default 1.0 <1.0 mg/kg
Signed : 16/10/2013

NOTES
Page 1 of 1

NUMBER P0006-03
REPORTING PERIOD: November, 2013
The certificate on the following summarises the analytical results for a sample than was taken on 25-Nov-2013.
ENVIRONMENTAL
LABORATORY SERVICES
Blackrock,
Cork
Ireland
Tel: +353 21 453 6141
Fax: +353 21 453 6149


AQ2-UP2
Metals-Total
Selenium-Total (Solid) EM130 1.0 <1.0 mg/kg DW
SVOC (Sub)(Solid)
Signed : 03/01/2014

NOTES
Page 1 of 1

NUMBER P0006-03
REPORTING PERIOD: December, 2013
The certificate on the following summarises the analytical results for a sample than was taken on 13-Dec-2013.
ENVIRONMENTAL
LABORATORY SERVICES
Blackrock,
Cork
Ireland
Tel: +353 21 453 6141
Fax: +353 21 453 6149


AQ2-UP2
Metals-Total
Selenium-Total (Solid) EM130 1.0 <1.0 mg/kg DW
SVOC (Sub)(Solid)
Signed : 07/01/2014

NOTES
Page 1 of 1
Resource Consumption Summary 2013: Water and Energy
Water Source Consumption (m3)
Municipal Supply 262,619
Total 262,619
Fuel Type Consumption (GigaJoule)
Marked Gas Oil 2,355

Natural Gas 192,815
Electricity 157,510
Solvent Incinerated 51,851
On-Site
Total 404,531
Trend analyses for water, natural gas and electricity consumption/kg of product produced are
included on the following pages. Data for the years 2009 to 2013 are included on the trends.
Note that there was a significant impact on many of the environmental metrics reported on in
this section of the 2011 AER due to the later than anticipated start-up of the new E1W process
in the Diovan Process Unit during the first-quarter of 2011. Novartis Ringaskiddy Limited
introduced the E1W process during 2011. This work was undertaken in collaboration with
Novartis Pharmas Technical Research and Development Group and with the additional input of
the Diovan Process Units in Basel, Switzerland and Grimsby in the United Kingdom and has
demonstrated significant material and energy savings. These savings have been effected
primarily through process modification and optimisation; and there is further scope for saving as
the new process is established by increasing yield. A full years savings could not be realised
during 2011 as the new process was only successfully established at the end of the first-
quarter. A clearer view of the new process impact can now be seen in the data set for 2012 and
2013.
Water Consumption
Water consumption is expressed as m3 consumed per kilogramme of product manufactured.
m3 water/kg product
0.9
0.8
0.7
0.6
0.5
0.4
0.3
0.2
0.1
0
2009 2010 2011 2012 2013
Natural Gas Consumption
Natural Gas consumption is expressed as GigaJoule consumed per kilogramme of product

manufactured.
0.9
0.8
gigajoule/kg product
0.7
0.6
0.5
0.4
0.3
0.2
0.1
0
2009 2010 2011 2012 2013
Electricity Consumption
Electricity consumption is expressed as GigaJoule consumed per kilogramme of product

manufactured.
0.6
0.5
0.4
0.3
0.2
0.1
0
2009 2010 2011 2012 2013
Complaints Summary 2013
Complaint Class Noise Odour Water Dust Procedural Miscellaneous Total
Total (to NRL): 1 0 0 0 0 0 1

Total (to EPA): 0 1 0 0 0 0 1
The company received one complaint from a local neighbour in respect of noise that was being
generated during the daytime cleaning of one of the compartments of the companys Storm
Water Retention Pond that is located in the vicinity of the neighbours house. The company
ceased the activity on the day and contacted the neighbour to explain what was happening in
respect of the cleaning works.
The Environmental Protection Agency received one complaint of an environmental nature in

respect of the company. The complaint was in respect of odours that were detected at a
location to the southeast of the facility. The complaint was investigated by the company and it
does not consider that it was the source of the odours referred to in the complaint.
Reported Incidents Summary 2013
Novartis Ringaskiddy Limited did not report any major incident to the Agency during 2013. The
overall environmental compliance of Novartis Ringaskiddy Limited in respect of the imposed
licence conditions was 99.98 % during the period from January 2013, to December, 2013
(inclusive). Fifty-four readings out of a total of more than 228,000 were judged to be in non-
compliance and were reported to the Environmental Protection Agency. All non-compliances
were judged to be minor deviations and did not present the potential for having an adverse
effect on the local environment. Note from the Emissions to Atmosphere Summary and the
Emissions to Sewer Summary of this AER that the mass discharges of all licensed parameters
were substantially below the regulated amounts and that the overall performance of key
environmental control modules at the facility was excellent during 2013. It is also worth noting
that despite this performance that the regulatory requirement in respect of testing has grown
significantly in recent years. A total of more than 133,000 test results were reported on during
2005 compared to more than 228,000 results in 2013.
Category of Notified Incidents: All five deviations fell into Category 1
(Environmental incidents are categorised from 1 to 5 based on Agency Guidance; and also
those emissions that do not comply with the requirements of IEL Register Number P0006-03)
Table Environmental Impact Assessment Criteria (Agency Guidance)
Ranking Classification Impact on the environment

1 Minor No contamination, localised effects
Minor effect on air quality as evidenced by dust or
odour complaint(s)
ELV breaches
An emission which does not comply with the
requirement of the licence (A pattern of repeated minor
incidents should be taken into account when
considering the level of response)
2 Limited Simple contamination, localised effects of short
duration
Local limited impact to water, land and air
Notification to and short term closure of potable water
extractors required
3 Serious Simple contamination, widespread effects of
extended duration
Significant effects on water quality
Major damage to an ecosystem (e.g. significant impact
on fish population)
Longer term closure of potable water extractors
Significant reduction in amenity value
Significant Damage to agriculture or commerce
Significant Impact on man
4 Very Serious Heavy contamination, localised effects of extended
duration
5 Catastrophic Very heavy contamination, widespread effects of
extended duration
The following three pages briefly summarise the aforementioned five non-compliances. This
summary is then followed by a more detailed breakdown of the non-compliances.
Novartis Ringaskiddy Limited: Environmental Compliance Data:
Summary: January 2013 to December 2013 (inclusive).
The overall environmental compliance of Novartis Ringaskiddy Limited in respect of the imposed licence
conditions was 99.98 % during the period from January 2013 to November 2013 (inclusive). Fifty-four
readings out of a total of more than 228,000 were judged to be in non-compliance and were reported to
the Environmental Protection Agency. All non-compliances were judged to be minor deviations and did
not present the potential for having an adverse effect on the local environment. More detailed information
on compliance reporting to the Environmental Protection Agency is given on the following pages.
Solid Waste Incinerator (Emission Point Reference Number 3)
Continuous Monitoring: Carbon Monoxide: >99% compliance (30 minute means)

" (Non-compliance 3 out of 4,088 readings)
Sulphur Dioxide: 100% compliance
Hydrochloric Acid: 100% compliance
Particulates: 100% compliance
Total Organic Carbon: 100% compliance
Nitrogen Oxides 100% compliance
Flow: 100% compliance
Occasional Monitoring: Hydrogen Fluoride: 100% compliance

Hydrogen Bromide: 100% compliance
Dioxins and
Dibenzofurans: 100% compliance
Metals: 100% compliance
Liquid Vapour Incinerator (Emission Point Reference Number 4)
Continuous Monitoring: Carbon Monoxide: 100% compliance

Sulphur Dioxide: 100% compliance
Particulates: 100% compliance
Hydrochloric Acid: 100% compliance
Total Organic Carbon: 100% compliance
Nitrogen Oxides 100% compliance
Occasional Monitoring: Hydrogen Fluoride: 100% compliance

Hydrogen Bromide: 100% compliance
Dioxins and
Dibenzofurans: 100% compliance
Metals: 100% compliance
NOTE: Daily mass discharges of all parameters from Emission Point Reference Number 3 and 4 were in 100% compliance
with the requirements of Industrial Emissions Licence Register Number P0006-03
_____________________________________________________________________________________________________
Parameters as required by Industrial Emissions Licence (IEL) Register Number P0006-03.
Air Emissions were controlled under Air Pollution Register Number: A.P. 2/1993 (R) up to 16-May-1995 after which Integrated
Pollution Control Licence (IPCL) Register Number 6, issued by the Environmental Protection Agency, came into force. IPCL
Register Number 6 was superseded by IPCL Register Number 545 on 31-Oct-2000. This was superseded in turn by IEL
Register Number P0006-03 on 02-Feb-2006.
Treated Effluent (Wastewater Treatment Plant)(Emission Point Reference Number 100)
Daily Monitoring of Mass Discharges and Concentrations:
Total Suspended Solids: 97% compliance

(Non-compliance 10 out of 365 readings)
Total Phosphorus: 100% compliance
Total Kjeldahl Nitrogen: 100% compliance
Total Ammonia: 100% compliance
Nitrate Nitrogen 100% compliance
Chemical Oxygen Demand: 89% compliance
(Non-compliance 41 out of 365 readings)
Biochemical Oxygen Demand: 100% compliance
Copper: 100% compliance
Zinc: 100% compliance
Continuous Monitoring of pH:
pH: 100% compliance
Daily Monitoring of Conductivity:
Conductivity: 100% compliance
Occasional Monitoring of Treated Effluent Toxicity:
Toxicity: 100% compliance
Sound Level Monitoring

Sound levels at the boundary of Novartis Ringaskiddy Limited were demonstrated to be compliant with the requirements of
Industrial Emissions Licence Register Number P0006-03 during the annual sound level surveys between 2004 and 2013.
Groundwater Quality
The quality of the groundwater beneath the facility has remained the same as that established prior to the commencement of
the development at Novartis Ringaskiddy Limited.
Surface Water Quality

All surface water leaving the site was monitored, found to be of an acceptable quality for discharge and conformed to the
requirements of Industrial Emissions Licence Register Number P0006-03.
_____________________________________________________________________________________________________
Parameters as required by Industrial Emissions Licence (IEL) Register Number P0006-03.
Treated effluent emissions and the quality of groundwater under the facility were controlled under Licence Register Number:
W.P. (S) 7/1993 (R) up to 16-May-1995 after which IPCL Register Number 6, issued by the Environmental Protection Agency,
came into force. IPCL Register Number 6 was superseded by IPCL Register Number 545 on 31-Oct-2000. This was
superseded in turn by IEL Register Number P0006-03 on 02-Feb-2006.
Sound levels at the boundary of the facility were controlled under Planning Register Reference Number: S/2989/89 up to 16-
May-1995 after which IPCL Register Number 6, issued by the Environmental Protection Agency, came into force. IPCL Register
Number 6 was superseded by IPCL Register Number 545 on 31-Oct-2000. This was superseded in turn by IEL Register
Number P0006-03 on 02-Feb-2006.
Reported Incidents Summary 2013: Emission Point Reference Number 3
Date: 20-Aug-2103: 16:30 to 17:00
20-Aug-2103: 17:30 to 18:00
06-Dec-2103: 21:00 to 21:30

Parameter: Carbon Monoxide (CO).
Emission Point Emission Point Reference Number 3 (Solid Waste Incinerator).
Reference Number:
Number of 3 out of 4,088 (> 99 % compliance)(thirty minute mean concentration
Exceedences vs. levels).
Number of 0 out of 4,088 (100 % compliance)(thirty minute mean mass
Samples: discharges).
Maximum 109 mg/Nm3 vs. 100 mg/Nm3. (Corresponding mass discharge 0.09 kg
Exceedence vs. vs. 0.50 kg).
Emission Limit
Value:
Cause: Readings of 20-Aug-2013:
The primary cause of these reportable deviations was that an off-set on

the CO analyser needed to be reset to its normal operational position
following QAL2 validation on the Continuous Emission Monitoring
(CEM) System for the Solid Waste Incinerator. This was considered to
be the main contributory factor that gave rise to these two readings
being reported. Note that the two readings overstated the actual
emission and were relatively conservative.
The secondary underlying cause of the deviations was insufficient

oxygen to support combustion over a period of some three to four
minutes during the time periods in question. Although the air induction
fans did increase in speed to introduce more air into the combustion
chamber it wasnt enough during this critical period.
Reading of 06-Dec-2013:
The initial investigation on Monday 09-Dec-2013 indicated that:
1. The loader ram had not completed a full cycle (thereby leaving a
waste pack undischarged to the incinerator in the hopper).
2. A second pack of floor sweepings (housekeeping from under the

Solid Waste Incinerator) was loaded manually to the loader hopper.
3. The operator did not see the other pack in the hopper as it he
assumed the hopper was empty since the ram was retracted.
4. The operator noticed after a short time period that the loader ram
needed to be reset, which was carried out by an
Electrical/Instrumentation craft person.
The introduction of two lots of solid waste rather than one resulted in
a short-term reduction in oxygen concentrations that consequently
resulted in the generation of CO.
Corrective Action: Readings of 20-Aug-2013:
The control systems on the Solid Waste Incinerator stopped feeding

waste to the unit once the trend to elevated concentrations was
recorded. The system would have recommenced the solid waste stream
at a reduced loading to ensure that there were no subsequent repeat
readings. No further ELV breaches were recorded on Tuesday 20-Aug-
2013.
A number of corrective and preventative actions were identified

following an initial investigation on the morning of Wednesday 21-
Aug-2013 and these were followed up on-site:
1. A review was undertaken to determine whether the pleated filter

bags that are used in the baghouse need to be changed as this may be
affecting the differential pressure across the bagfilter housing, which
may in turn affect the performance of the Solid Waste Incinerator.
These have been in place for approximately five years. It is unlikely
that this was a significant contributory factor to the two reported
results.
2. Full implementation of the QAL2 testing for the Solid Waste

incinerator CO analyser was implemented, however a recent evaluation
of the monitoring system indicated that the current readings were
approximately 20% greater than the actual readings because an off-set
factor that was used to support the QAL testing needs to be
implemented. This was already scheduled to take place at the time of
the incident by an outside contractor. The off-set on the CO analyser
was subsequently reset to its normal operational position and the
Continuous Emission Monitoring (CEM) System for the Solid Waste
Incinerator is now fully validated. This is considered to be the main
contributory factor that gave rise to these two readings being reported.
Note that the two readings overstated the actual emission and were
quite conservative.
3. A full mechanical inspection of the Solid Waste Incinerator was

undertaken to ensure that there was no ingress of air that may be
adversely affecting the concentration of oxygen in the exhaust stack
(where the sample for emissions monitoring is taken). A damper in the
primary combustion zone was subsequently found to have failed open.
This would not have resulted in the generation of excess Carbon
Monoxide. An actuator and two positioners were replaced in the
damper, which is now opening and closing depending on the demand
for combustion air in the primary combustion chamber. It is unlikely
that this was a significant contributory factor to the two reported
results.
4. Undertake a refresher information session with the Process Units

that generate waste to emphasis the types of waste that can be sent for
on-site solid incineration and how this waste needs to be labelled and
weighed correctly. This type of training was last delivered
approximately twelve months ago.
Reading of 06-Dec-2013:
The control systems on the Solid Waste Incinerator stopped feeding

waste to the unit once the trend to elevated concentrations was
recorded. The system would have recommenced the solid waste stream
at a reduced loading to ensure that there were no subsequent repeat
readings. No further ELV breaches were recorded on Friday 06-Dec-
2013.
The following initial corrective actions were identified and

implemented:
1. Erect signage that before commencing auto/manual loading that the

ram/loader is cycled once in manual before commencing incineration
operations.
2. Signage to include that on all resets of the ram/loader that it is

manually cycled before commencing incineration activities.
3. Insert these instructions into the electronic logbook for the

Environmental Controls Department area.
4. Inform all operational personnel by email of these requirements.
All Solid Waste Incinerator area housekeeping waste needs to be logged

and tracked on the Waste Tracking System.
Percentage compliance for thirty-minute (concentration) mean CO

emissions from the Solid Waste Incinerator was greater than 99 %
during 2013. Percentage compliance for ten-minute and twenty-four
hour (concentration) mean CO emissions was 100%. All mass
discharges of CO were within the controlled amounts; and note that
the mass discharge of CO was less than 1% of the controlled amount
over the course of the year.
100
90
80
70
60
50
40
30
20
10
0
CO
Mass Discharge of Carbon Monoxide (CO) from Solid Waste Incinerator

(first column) Expressed as a Percentage of the Discharge Regulated
Under IEL Register Number P0006-03 (Second Column): 2013

Date: 23-Apr-2013: 00:00 to 24:00
24-Apr-2013: 00:00 to 24:00
14-May-2013: 00:00 to 24:00
15-May-2013: 00:00 to 24:00
16-May-2013: 00:00 to 24:00
17-May-2013: 00:00 to 24:00
18-May-2013: 00:00 to 24:00
19-May-2013: 00:00 to 24:00
20-May-2013: 00:00 to 24:00
21-May-2013: 00:00 to 24:00
22-May-2013: 00:00 to 24:00
23-May-2013: 00:00 to 24:00
27-May-2013: 00:00 to 24:00
28-May-2013: 00:00 to 24:00
29-May-2013: 00:00 to 24:00
30-May-2013: 00:00 to 24:00
31-May-2013: 00:00 to 24:00
01-Jun-2013: 00:00 to 24:00
02-Jun-2013: 00:00 to 24:00
03-Jun-2013: 00:00 to 24:00
04-Jun-2013: 00:00 to 24:00
05-Jun-2013: 00:00 to 24:00
06-Jun-2013: 00:00 to 24:00

07-Jun-2013: 00:00 to 24:00
08-Jun-2013: 00:00 to 24:00
09-Jun-2013: 00:00 to 24:00
10-Jun-2013: 00:00 to 24:00
12-Jun-2013: 00:00 to 24:00
13-Jun-2013: 00:00 to 24:00
14-Jun-2013: 00:00 to 24:00
15-Jun-2013: 00:00 to 24:00
16-Jun-2013: 00:00 to 24:00
17-Jun-2013: 00:00 to 24:00
18-Jun-2013: 00:00 to 24:00
19-Jun-2013: 00:00 to 24:00
20-Jun-2013: 00:00 to 24:00
21-Jun-2013: 00:00 to 24:00
29-Jun-2013: 00:00 to 24:00
30-Jun-2013: 00:00 to 24:00
01-Jul-2013: 00:00 to 24:00
02-Jul-2013: 00:00 to 24:00

Parameter: Chemical Oxygen Demand (COD).
Emission Point Emission Point Reference Number 100 (Wastewater Treatment Plant).
Reference Number:
Number of 41 out of 365 (89 % compliance).
Exceedences vs.
Number of
Samples:
Maximum 1,630 mg/L vs. 700 mg/L. (Corresponding mass discharge 880 kgs vs.
Exceedence vs. 630 kgs).
Emission Limit
Value:
Cause: Detailed communication was undertaken with the Environmental
Protection Agency in respect of the readings recorded during May, June
and July of 2013, the underlying issues with the Wastewater Treatment
Plant, relevant corrective actions and the environmental impact
associated with these readings. A copy of the correspondence with the
Agency up to the end of July, 2013 is appended to this document.
Corrective Action: The readings were not of especial environmental significance. The
deviations recorded for COD were associated with a loss of biomass
(bacterial and fungal material) that is used to treat aqueous waste. The
underlying treatment of aqueous waste was not affected during this
period. The biomass that was lost would be co-mixed with untreated
sanitary wastewater from the nearby town of Carrigaline and it would
finally discharge (without further treatment) in deep water inside the
mouth of Cork Harbour. No adverse environmental impact is
anticipated given the biodegradable nature of the biomass and the fact
that the monthly mass discharges for COD were less than the
controlled amounts during the reporting period.
Note that the annual mass discharge of COD was approximately one-
fifth of the controlled amount during 2013.
100
90
80
70
60
50
40
30
20
10
0
COD
Mass Discharge of Chemical Oxygen Demand from Wastewater Treatment Plant

Legend: COD: Chemical Oxygen Demand

Date: 02-Feb-2013: 00:00 to 24:00
04-Feb-2013: 00:00 to 24:00
05-Feb-2013: 00:00 to 24:00
17-May-2013: 00:00 to 24:00
27-May-2013: 00:00 to 24:00
31-May-2013: 00:00 to 24:00
02-Jun-2013: 00:00 to 24:00
03-Jun-2013: 00:00 to 24:00
04-Jun-2013: 00:00 to 24:00
05-Jun-2013: 00:00 to 24:00

Parameter: Total Suspended Solids (TSS).
Emission Point Emission Point Reference Number 100 (Wastewater Treatment Plant).
Reference Number:
Number of 10 out of 365 (97 % compliance).
Exceedences vs.
Number of
Samples:
Maximum 1,320 mg/L vs. 500 mg/L. (Corresponding mass discharge 634 kgs vs.
Exceedence vs. 225 kgs).
Emission Limit
Value:
Cause: Readings of February, 2013:
The readings of February, 2013 were related to poor settlement in one

of the two operational clarifiers of the Wastewater Treatment Plant;
and the underlying biological treatment in the Wastewater Treatment
Plant was not affected. Corrective action was instigated on the morning
of Monday 04-Feb-2013. The forward flow through the affected
clarifier was reduced to aid settlement. The companys Wastewater
Treatment Plant consultants were also on-site and recommended the
use of Aluminium Chloride to further aid settlement in the affected
clarifier. This immediate corrective action returned the plant to a good
performance on the afternoon of Monday 04-Feb-2013.
Readings of May and June, 2013:

Detailed communication was undertaken with the Environmental
Protection Agency in respect of these readings, the underlying issues
with the Wastewater Treatment Plant, the relevant corrective actions
and the environmental impact associated with these readings. A copy of
the correspondence with the Agency up to the end of July, 2013 is
appended to this document.
Corrective Action: Readings of February, 2013:
The local root cause investigation by the area Coordinator found that
the polymer addition to the Clarifier in question was not functioning
correctly and insufficient polymer had been fed to the Clarifier. The
reason for insufficient polymer addition to the Clarifier was a defective
pump /check valve. A replacement pump was sourced on Tuesday 05-
Feb-2013 and in the meantime polymer was added to the Clarifier
manually.
An upgraded pump was installed on Thursday 07-Feb-2013 and

addition of polymer to the Clarifier was verified. A further evaluation
will be taken on upgrading the polymer pumping-in station and also a
facility to add Aluminium Chloride to each Clarifier when necessary. A
simple visual check of the final effluent for weekend periods will also
be developed and implemented.
The readings were not of especial environmental significance. The

deviations recorded for TSS were associated with a loss of biomass
(bacterial and fungal material) that is used to treat aqueous waste. As
noted above the underlying treatment of aqueous waste was not
affected during this period. The biomass that was lost would be co-
mixed with untreated sanitary wastewater from the nearby town of
Carrigaline and it would finally discharge (without further treatment)
in deep water inside the mouth of Cork Harbour. No adverse
environmental impact is anticipated given the biodegradable nature of
the biosolids and the relatively small amounts involved.
Readings of May and June, 2013:
The readings were not of especial environmental significance. The

deviations recorded for TSS were associated with a loss of biomass
(bacterial and fungal material) that is used to treat aqueous waste. The
underlying treatment of aqueous waste was not affected during this
period. The biomass that was lost would be co-mixed with untreated
sanitary wastewater from the nearby town of Carrigaline and it would
finally discharge (without further treatment) in deep water inside the
mouth of Cork Harbour. No adverse environmental impact is
anticipated given the biodegradable nature of the biomass and the fact
that the monthly mass discharges for TSS were less than the controlled
amounts during the reporting period.
Note that the annual mass discharge of TSS was approximately one-
fifth of the controlled amount during 2013.
100
90
80
70
60
50
40
30
20
10
0
TSS
Mass Discharge of Total Suspended Solids from Wastewater Treatment Plant

Legend: TSS: Total Suspended Solids

Attachment 1
Correspondence with the Environmental Protection Agency

in respect of the deviations recorded for TSS and COD
during May, June and July of 2013
Vincent Boyton Novartis Ringaskiddy Limited
E + IH Services Manager Ringaskiddy
Health, Safety and Co. Cork
Environmental Protection Ireland
Tel +353-21-4862324
Fax +353-21-4862358
Enforcement Team B
OEE Regional Office
Environmental Protection Agency
Inniscarra
County Cork
01 Aug 2013
IPC10433_update 01 Aug 2013.doc
Fax: 021- 4875545 (42 pages including this one)
FAO: Enforcement Team B
Re: Notification of IPPCL Non-Compliance
To whom it may concern,
attached is an update to the preliminary notification of an IPPCL non-compliance for

emissions of Chemical Oxygen Demand (COD) from the companys Wastewater Treatment
Plant (WWTP), which in turn is caused by the loss of Total Suspended Solids (TSS) from the
WWTP. The issue is related to poor settlement in the one operational Clarifier in the
WWTP; and the underlying biological treatment in the WWTP is not affected.
Note that the mass discharge of COD was 64% of the controlled amount during the month
of May; 57% of the controlled amount during the month of June; and 16% of the controlled
amount during the month of July.
Note that the mass discharge of TSS was 56% of the controlled amount during the month of
May; 56% of the controlled amount during the month of June; and 17% of the controlled
amount during the month of July.
Corrective action was instigated on the morning of Wednesday, 15-May-2013. The forward
flow through the affected clarifier has been reduced to aid settlement. The companys
WWTP consultants have also been on-site and are currently trying to optimise the use of
polymers to further aid settlement.
A number of additional corrective actions were taken on 16-May-2013:
Forward feed is now at minimum rate consistent with maintaining adequate ullage in
the equalisation tank (13 m3/h). This will be reviewed again in the morning.
1 tonne of Nutrifeed M was added to the operational aeration basin to boost

inorganics and aid settlement (as per yesterday).
Biomass booster added to the operational aeration basin at 14:00 today. Additions to
continue for the next three days.
Forward feed is now split so that approximately half of the forward feed going into
the WWTP will be diverted to a holding basin. This is to give the biomass a better
opportunity to return to a state of good settlement.
Nutrifeed M will continue to be added to the operational aeration basin to boost

inorganics and aid settlement over the weekend.
Additional Biomass booster will be added to the operational aeration basin over the
next two days.
Additional phosphoric acid will be added to boost the nutrients available to the
existing and new biomass.
A sample of the treated effluent will be analysed for particle size distribution. The
test, which can take up to four days to complete, will be used to evaluate the options
for use of a mobile filter if good settlement is not restored in the coming days.
A sample of the influent waste streams will be analysed for respiratory inhibition
(note that there appears to be good biological removal of COD within the treatment
process at this point in time).
Pending the availability of particle size test results on the solids in the treated effluent
some preparatory work is to be undertaken to facilitate the installation of an on-line
filter after the effluent passes through the operational clarifier and before the
composite sampler. The particle size analysis result is anticipated to be available on
Tuesday 21-May-2013.
The concentration of the influent COD to the WWTP has decreased significantly over
the past two months from approximately 7,000 mg/l to 3,500 mg/l COD. There is
good uptake of the available COD in the treatment plant and from today it is
proposed to bring the concentration of the influent COD up to approximately 5,000
mg/l. It may be that the relatively low input of COD may be having an adverse effect
on the WWTPs biomass in respect of its settlement profile.
An additional mechanical walk-down of the WWTP is to be undertaken today to

ensure that no blockages, air pockets etc. are being overlooked.
The concentration of the influent COD to the WWTP has been increased over the
past twenty-four hours to approximately 5,000 mg/l by the addition of a
supplementary mixture of water and Ethyl Acetate. This will be maintained over the
coming days. This action does appear to have stimulated additional metabolic activity
in the biological section of the WWTP and may play a role in promotion of a biomass
with a better settlement profile.
The possibility of adding an external source of biomass to the biological section of

the WWTP is under review. A number of potential sources have been identified; and a
decision on implementing this measure will only be taken after two days to three days
of maintaining an influent wastewater with a COD of approximately 5,000 mg/l.
The particle size analysis of the treated effluent is still under determination in a
specialist laboratory in the United Kingdom.

One tonne of Ferric Chloride has been added to the biological section of the WWTP
after recent jar tests indicated that it was having a beneficial effect in terms of
clarifying the treated effluent.
A filter housing unit has been put in line with the treated effluent discharge from the
clarifier in the WWTP. This unit, which holds a 100 micron filter, is upstream of the
composite sampler at Emission Point Reference Number 100. The performance of this
unit will be evaluated on 23-May-2013.
The decision on the use of an external source of biomass has been deferred pending
an evaluation of the use of the filter housing unit and the addition of Ferric Chloride.
The addition of Ferric Chloride has had a positive effect on promotion of better
settlement of the biomass in the clarifier. A grab sample of treated effluent that was
taken at 09:00 on 23-May-2013 indicates an effluent with a COD of 588 mg/l and a
TSS of 166 mg/l; and a potentially compliant sample for the period of 08:00, 23-May-
2013 to 08:00, 24-May-2013 (to be confirmed tomorrow).
The addition Ferric Chloride will be continued over the coming days to enable better
settlement of the biomass.
The 100 micron filter housing unit did not have any appreciable effect on solids
removal and a filter with a smaller pore size of 20 microns is being trialed today.
The target influent COD concentration of 5,000 mg/l will be maintained over the
coming days at it would appear to have promoted better biological activity within the
one operational aeration basin.
Update: 24-May-2013:
The addition of Ferric Chloride has had a positive effect on promotion of better
settlement of the biomass in the clarifier. The twenty-four hour composite sample of
treated effluent that was sampled between 08:00, 23-May-2013 and 08:00, 24-May-
2013 was compliant both for COD with a reading of 583 mg/l (mass discharge of 315
kgs); and TSS with a reading of 152 mg/l (mass discharge of 82 kgs). A grab sample of
treated effluent that was taken at 09:00 on 24-May-2013 indicates continuing
improvement and an effluent with a COD of 127 mg/l and a TSS of 49 mg/l (and a
second potentially compliant sample for the period of 08:00, 24-May-2013 to 08:00,
25-May-2013).
The addition Ferric Chloride will be continued over the weekend to enable better
settlement of the biomass.
The 20 micron filter housing unit did not have any appreciable effect on solids
removal and a filter with a smaller pore size of 1.5 microns is being trialed today (as a
back-up to the use of Ferric Chloride).
The target influent COD concentration of 5,000 mg/l will be maintained over the
coming days at it would appear to have promoted better biological activity within the
one operational aeration basin.
Additional inorganic material was added to aid flocculation once the trend towards
elevated TSS in the treated effluent was identified.
The 1.5 micron filter housing unit did not have any appreciable effect on solids
removal and a filter with a smaller pore size of 1 micron is currently being sourced.
A number of cleaning agents used in various parts of the facility are to be removed
from the influent wastewater streams to the WWTP as a precautionary measure. These
are bacterial disinfectants used in relatively small amounts.
A twice daily cleaning regime is to be implemented on the oxygen probe in the

operational aeration basin as the air input to the aeration basin is more variable than
what would be expected from organic content of the influent wastewater streams to
the WWTP.
A filter with a smaller pore size of 1 micron is currently being installed (as a back-up
to the use of Ferric Chloride). Note that this is a relatively small pore size and gives
some indication as to the small size of the pin-flocs of biomass that are causing the
current problem.
An additional corrective action was taken on 29-May-2013:
Agreement was reached on-site to stop all of the main process related aqueous
wastewater streams entering the WWTP. A further meeting is scheduled for 30-May-
2013 to identify alternative treatment options for these wastewater streams.
Agreement was reached on-site to divert all of the main process related aqueous
wastewater streams away from the WWTP until such time as the WWTP can be
returned to a sustainable compliant state of operation. These streams will be routed
for off-site treatment on an interim basis. The other main streams currently entering
the WWTP include the inputs from the sites sanitary system and utility related
operations such as boiler blowdowns and blowdowns from water purification systems.
Confirmation was received from all of the Production Units on-site that the main
process related aqueous wastewater streams have been diverted away from the WWTP
until such time as the WWTP can be returned to a sustainable compliant state of
operation.
A monitoring plan has been put in place for the forthcoming weekend to track
changes arising from the removal of the main process related aqueous wastewater
streams from the influent waste streams. This will be important as the biological
section of the WWTP will require some supplementary feed until such time as it is
restored to a normal operating condition.
A number of additional corrective actions were taken on 04-Jun-2013:
Aqueous waste streams continue to be diverted away from the WWTP until such time
as the WWTP can be returned to a sustainable compliant state of operation.
Daily meetings held over the Bank Holiday weekend (01-Jun-2013 to 03-Jun-2013)
between Operations and site HSE to keep abreast of the situation to ensure that
agreed actions continue to be implemented
In consultation with our consultants (ENVA), an evaluation is being performed on

the existing biomass and its likely rate of recovery.
Examining options to revive WWTP by transfer in of external biomass to the aeration

basin. (source to be determined)
ENVA carrying out pilot plant testing at present to ascertain the most effective
option.
Aqueous waste streams continue to be diverted away from the WWTP until such
time as the WWTP can be returned to a sustainable compliant state of operation.
The aeration basin is showing signs of recovery as indicated by filtered COD sample.
Results of a polytox test carried out by ENVA have shown a significant increase in the
oxygen uptake of the plant.
Pilot plant testing by ENVA has identified a potential biomass from a local
biopharmaceutical plant will enhance the recovery of the WWTP.
The next site formal incident review meeting will be held on 06-Jun-2013.
Aqueous waste streams continue to be diverted away from the WWTP until such
time as the WWTP can be returned to a sustainable compliant state of operation.
The overall health of the WWTP is showing signs of improvement as can be seen
from the results in the Details of the ELV Exceedance section of this document.
Biomass from a neighbouring pharmaceutical facility WWTP will be used to

supplement the recovery of the aeration basins. Initially 40 tonnes will be added to the
aeration basin on 07-Jun-2013 with an additional 60 tonnes to be added over 10-Jun-
2013 and 11-Jun-2013.
Commenced transfer in of biomass (34 tonnes) from neighbouring pharmaceutical
API facility to supplement the recovery of the aeration basin.
WWTP is being allowed to settle over the weekend and transfer in of biomass (66
tonnes) from neighbouring pharmaceutical API facility will re-commence on Monday
10-Jun-2013.
A significant improvement has been noticed in the TSS and COD figures.
Transfer in of biomass (34 tonnes) from neighbouring pharmaceutical API facility has
continued on 10-Jun2013.
It is planned to transfer in a further 32 tonnes of biomass in the latter half of this

week.
The twenty-four hour composite sample of treated effluent that was sampled between
08:00, 10-Jun-2013 and 08:00, 11-Jun-2013 was compliant both for COD with a
reading of 580 mg/l (mass discharge of 191 kgs); and TSS with a reading of 176 mg/l
(mass discharge of 58 kgs).
We will assess the plant over next week prior to the reintroduction of process
streams.
It is planned to transfer in a further 32 tonnes of biomass in the latter half of this

week.
as the WWTP can be returned to a sustainable compliant state of operation
We will continue to monitor the recovery of the plant and adjust the addition of feed
to maintain optimum MLSS at 5000 mg/l in the aeration basin.
On-going corrective actions on 13-Jun-2013:
as the WWTP can be returned to a sustainable compliant state of operation
The plant will be monitored over the weekend with samples being taken and
analysed by ENVA and reported daily to relevant Site Heads
A number of additional corrective actions were agreed on 17-Jun-2013:
Preparations are now underway on-site to reactivate one of the WWTPs other
aeration basins and the one other clarifier, which was off-line for inspection and
maintenance.
It has been agreed with the companys WWTP consultants that the second
combination of aeration basin and clarifier will be started in parallel to the currently
operational aeration basin and clarifier; and will be seeded with biomass sourced
externally.
Final hydraulic testing of the aeration basin that is to be reactivated; and the clarifier
that was off-line for inspection and maintenance will take place on Tuesday 18-Jun-
2013.
A number of (continuing and) additional corrective actions were agreed on 18-Jun-2013:
Preparations are now underway on-site to reactivate one of the WWTPs other
aeration basins and the one other clarifier, which was off-line for inspection and
maintenance.
externally. Confirmation of the source will be made on Wednesday 19-Jun-2013.
that was off-line for inspection and maintenance is currently taking place (Tuesday 18-
Jun-2013).
that was off-line for inspection and maintenance has been completed.
Preparations are now underway on-site to reseed one of the WWTPs other aeration
basins and make the one other clarifier, which was off-line for inspection and
maintenance, operational.
externally. It is hoped to deliver the first batch of this biomass on Thursday.
Operations are now underway on-site to reseed one of the WWTPs other aeration
externally. The first batch of this biomass is currently being introduced to the aeration
basin and this will be bulked up under controlled conditions over the coming days.
Operations are now continuing on-site to reseed one of the WWTPs other aeration
externally. The first batch of this biomass was introduced to the aeration basin on
Thursday 20-Jun-2013; and additional material is currently being added on Friday 21-
Jun-2013. This will be bulked up under controlled conditions over the coming days.
A number of continuing corrective actions are on-going as of 24-Jun-2013:
maintenance, operational. The aeration basin in question is now approximately half-
full. Externally sourced biomass was added to this basin on Thursday 20-Jun-2013;
and Friday 21-Jun-2013. No further additions are anticipated and the plan is to bulk
this material up under controlled conditions over the coming days.
maintenance, operational. The aeration basin in question is now approximately half-
full. Externally sourced biomass was added to this basin on Thursday 20-Jun-2013;
and Friday 21-Jun-2013. No further additions are anticipated and the plan is to bulk
this material up under controlled conditions over the coming days. Note that four
consecutive twenty-four hour composite samples have returned compliant results over
the past four days.
maintenance, operational. The aeration basin in question is now approximately three-
quarters full. Externally sourced biomass was added to this basin on Thursday 20-Jun-
2013; and Friday 21-Jun-2013. No further additions are anticipated and the plan is to
bulk this material up under controlled conditions over the coming days. Note that five
consecutive twenty-four hour composite samples have returned compliant results over
the past four days.
As part of this work forward feed (less the production aqueous waste streams that
have been diverted away from the wastewater treatment plant) is being introduced to
this aeration basin at a rate of approximately 2 m3/hour together with some sanitary
wastewater. This will help increase the residence time in the one operational aeration
basin and help progress towards a stable and compliant operation.
Six consecutive days of compliant readings for the discharge of COD and TSS have
been notified to the EPA since Saturday 22-Jun-2013. While there has been a
recovery in the operational aeration basin it still isnt at a stage where process
wastewater streams can be reintroduced to the Wastewater Treatment Plant
(WWTP). The EPA will continue to be updated on a daily basis until such time as
routine treatment of process wastewater streams resumes at the facility.
maintenance, operational. The aeration basin in question is now nearly full; and will
commence overflowing to the recently serviced clarifier in the coming day or two.
Externally sourced biomass was added to this basin on Thursday 20-Jun-2013; and
Friday 21-Jun-2013. No further additions are anticipated and the plan is to bulk this
material up under controlled conditions over the coming days. It may be possible to
consider the phased reintroduction of process wastewater streams from the end of
next week depending on the growth curve of this new biomass.
As part of this reseeding work forward feed (less the production aqueous waste
streams that have been diverted away from the wastewater treatment plant) is being
introduced to this aeration basin at a rate of approximately 4 m3/hour together with
some sanitary wastewater. This will help increase the residence time in the one
operational aeration basin possibly help to promote a more stable biomass in that
basin.
A number of continuing corrective actions are on-going as of 01-Jul-2013:
maintenance, operational. The aeration basin in question is now full and has
commenced overflowing to the recently serviced clarifier, which will now fill over the
coming days.
Externally sourced biomass was added to this basin on Thursday 20-Jun-2013; and
Friday 21-Jun-2013. No further additions are anticipated and the plan is to bulk this
material up under controlled conditions over the coming days. It may be possible to
consider the phased reintroduction of process wastewater streams from the end of
this week depending on the growth curve of this new biomass.
introduced to this aeration basin at a rate of approximately 4 m 3/hour together with
basin.
commenced overflowing to the recently serviced clarifier, which is now nearly full
and is anticipated to start discharging later today or tomorrow.
It may be possible to consider the phased reintroduction of process wastewater

streams from the end of this week depending on the growth curve of this new
biomass; and the compliance status of the treated effluent.
basin.
commenced overflowing to the recently serviced clarifier, which is now full and is
slowly overflowing to the treated effluent discharge line
It may be possible to consider the phased reintroduction of process wastewater

streams from the end of this week depending on the growth curve of this new
biomass; and the compliance status of the treated effluent.
basin. It is anticipated that the feed rate of will be slowly increased over the coming
days as this aeration basin takes more of the forward feed, which is made up
primarily of sanitary wastewater and utility related blowdowns.

slowly overflowing to the treated effluent discharge line.
A decision on the phased reintroduction of process wastewater swill now be

deferred until next week and will depend on the growth curve of this new biomass;
and the compliance status of the treated effluent.
basin.
slowly overflowing to the treated effluent discharge line. This has resulted in an
improvement in the quality of the treated effluent leaving the site.

deferred until next week and will depend on the growth curve of this new biomass;
and the compliance status of the treated effluent.
some sanitary wastewater. This process will continue during the coming week as
more of the site load is transferred on to this aeration basin.

maintenance, operational. The aeration basin in question is now nearly fully
operational and forward feed (less the production aqueous waste streams that have
been diverted away from the wastewater treatment plant) is being introduced to this
aeration basin at a rate of approximately 10 m3/hour together with some sanitary
wastewater. This process will continue during the coming week as more of the site
load is transferred on to this aeration basin.

deferred until the end of the current week and will depend on the growth curve of
this new biomass; and the compliance status of the treated effluent.
Operations are now continuing on-site to reseed one of the WWTPs other aeration basins
and make the one other clarifier, which was off-line for inspection and maintenance,
operational. The aeration basin in question is now nearly fully operational and forward feed
(less the production aqueous waste streams that have been diverted away from the
wastewater treatment plant) is being introduced to this aeration basin at a rate of
approximately 10 m3/hour together with some sanitary wastewater. This process will
continue during the coming week as more of the site load is transferred on to this aeration
basin. A decision on the phased reintroduction of process wastewater will now be made at
the end of the current week.
operational. The aeration basin in question is now fully operational and forward feed (less
the production aqueous waste streams that have been diverted away from the wastewater
treatment plant) is being introduced to this aeration basin at a rate of approximately 10
m3/hour together with approximately half of the sites sanitary wastewater. Most of the
sites load has now been transferred on to this aeration basin. A decision on the phased
reintroduction of process wastewater will be made at the end of the current week.
reintroduction of process wastewater will be made at the end of the current week. Note that
eight consecutive days of compliant readings have been recorded at this point in time.
Operations have now been completed on-site to reseed one of the WWTPs other aeration
basins and make the one other clarifier, which was off-line for inspection and maintenance,
reintroduction of process wastewater streams will be made at the start of the coming week.
Note that nine consecutive days of compliant readings have been recorded at this point in
time.
Operations have now been completed on-site to reseed one of the WWTPs other aeration
basins and make the one other clarifier, which was off-line for inspection and maintenance,
m3/hour together with approximately half of the sites sanitary wastewater.
Most of the sites load has now been transferred on to this aeration basin. The phased
reintroduction of process wastewater streams has now commenced and these will be brought
back on-line over a three week period. Note that twelve consecutive days of compliant
readings have been recorded at this point in time.
Planning has also commenced to fully reseed another aeration basin using externally
sourced biomass in the coming weeks.
A number of continuing corrective actions are on-going as of 16/17-Jul-2013:
Most of the sites load has now been transferred on to the aeration basin that was reseeded
over the past number of weeks using externally sourced biomass. The phased reintroduction
of process wastewater streams has now commenced and these will be brought back on-line
over a three week period. Note that two weeks of compliant readings have been recorded at
this point in time.
A number of continuing corrective actions are on-going as of 22/23-Jul-2013:
Most of the sites load has now been transferred on to the aeration basin that was reseeded
over the past number of weeks using externally sourced biomass. The phased reintroduction
of process wastewater streams has been on-going for over one week; and these will be
brought back on-line over another two week period. Note that approximately three weeks of
compliant readings have been recorded at this point in time.
A number of continuing corrective actions are on-going as of 24/25/26-Jul-2013:

The sites load has now been transferred on to the aeration basin that was reseeded over the
past number of weeks using externally sourced biomass. The phased reintroduction of
process wastewater streams has been on-going for two weeks; and these will be brought
back on-line over another two week period. Note that over three weeks of compliant
sourced biomass during the coming week. This aeration basin will be used as a back-up to
the one that is now currently functioning to specification.
The aeration basin whose biomass was adversely affected during the months of May, June
and early July is now being drained down and the contents transferred to the Wastewater
Treatment Plants aerobic digester. This basin will be cleaned and inspected for any
mechanical issues that may have had a contributory adverse effect its correct operation.
A number of continuing corrective actions are on-going as of 29/30/31-Jul-2013:
The sites load has now been transferred on to the aeration basin that was reseeded over the
past number of weeks using externally sourced biomass. The phased reintroduction of
process wastewater streams has been on-going for three weeks; and is now complete. Note
that four weeks of compliant readings have been recorded at this point in time.
The reseeding of another aeration basin using externally sourced biomass has now
commenced. This aeration basin will be used as a back-up to the one that is now currently
functioning to specification. The biomass that will be used to reseed this aeration basin will
come from the same source that was used to fully reseed the aeration basin that is now fully
operational and processing the site load.
The aeration basin whose biomass was adversely affected during the months of May, June
and early July is now being drained down and the contents transferred to the Wastewater
Treatment Plants aerobic digester. This basin will be cleaned and inspected for any
mechanical issues that may have had a contributory adverse effect its correct operation.
Annex 1 Incident Notification Form
Licence/COA Number IPPC Licence Register Number P0006-03

Licence/COA Name Novartis Ringaskiddy Limited
Licensee/COA Address: Ringaskiddy,
County Cork,
Ireland.
Incident notification form Vincent Boyton

submitted by:
Licensees/COA holders 1
Environmental Impact
Ranking: No contamination, localised effects
ELV breaches (An emission which does not comply with the
requirement of the licence/COA (A pattern of repeated
minor incidents should be taken into account when
considering the level of response)
Details of incident: Exceedence of licence limits for the discharge of Chemical Oxygen
Demand (COD), which in turn is caused by the loss of Total Suspended
Solids (TSS) from the companys Wastewater Treatment Plant (WWTP).
The issue is related to poor settlement in the one operational Clarifier in the
WWTP; and the underlying biological treatment in the WWTP is not
affected.
Note that the mass discharge of COD was 64% of the controlled amount
during the month of May; 57% of the controlled amount during the month
of June; and 16% of the controlled amount during the month of July.
Note that the mass discharge of TSS was 56% of the controlled amount
during the month of May; 56% of the controlled amount during the month
of June; and 17% of the controlled amount during the month of July.
Date of incident: Wednesday, 15-May-2013; Thursday, 16-May-2013; Friday 17-May-2013;
Saturday 18-May-2013; Sunday 19-May-2013; Monday 20-May-2013;
Tuesday 21-May-2013; Wednesday, 22-May-2012; Thursday, 23-May-
2013; Monday, 27-May-2013; Tuesday, 28-May-2013; Wednesday, 29-
May-2013; Thursday, 30-May-2013; Friday, 31-May-2013; Saturday, 01-
Jun- 2013; Sunday, 02-Jun-2013; Monday, 03-Jun-2013; Tuesday, 04-Jun-
2013; Wednesday, 05-Jun-2013; Thursday, 06-Jun-2013; Friday, 07-Jun-
2013; Saturday, 08-Jun-2013; Sunday, 09-Jun-2013; Monday, 10-Jun-2013;
Wednesday, 12-Jun-2013; Thursday, 13-Jun-2013; Friday, 14-Jun-2013;
Saturday 15-Jun-2013; Sunday, 16-Jun-2013; Monday, 17-Jun-2013;
Tuesday, 18-Jun-2013; Wednesday, 19-Jun-2013; Thursday, 20-Jun-2013;
Friday, 21-Jun-2013; Saturday, 29-Jun-2013; Sunday, 30-Jun-2013;
Monday, 01-Jul-2013; Tuesday, 02-Jul-2013; and Wednesday, 03-Jul-2013.
Approximate start time of Tuesday, 14-May-2013. This result is being reported on the twenty-four
incident(Provide range if time is not hour composite sample of treated effluent that was sampled between 08:00,
known) 14-May-2013 and 08:00, 15-May-2013; the twenty-four hour composite
sample of treated effluent that was sampled between 08:00, 15-May-2013
and 08:00, 16-May-2013; the twenty-four hour composite sample of treated
effluent that was sampled between 08:00, 16-May-2013 and 08:00, 17-
May-2013; the twenty-four hour composite sample of treated effluent that
was sampled between 08:00, 17-May-2013 and 08:00, 18-May-2013; the
twenty-four hour composite sample of treated effluent that was sampled
between 08:00, 18-May-2013 and 08:00, 19-May-2013; the twenty-four
hour composite sample of treated effluent that was sampled between 08:00,
19-May-2013 and 08:00, 20-May-2013; the twenty-four hour composite
between 08:00, 26-May-2013 and 08:00, 27-May-2013; the twenty-four
27-May-2013 and 08:00, 28-May-2013; the twenty-four hour composite
between 08:00, 31-May-2013 and 08:00, 01-Jun-2013; the twenty-four
01-Jun-2013 and 08:00, 02-Jun-2013; the twenty-four hour composite
sample of treated effluent that was sampled between 08:00, 02-Jun-2013
and 08:00, 03-Jun-2013; the twenty-four hour composite sample of treated
effluent that was sampled between 08:00, 03-Jun-2013 and 08:00, 04-Jun-
2013, the twenty-four hour composite sample of treated effluent that was
sampled between 08:00, 04-Jun-2013 and 08:00, 05-Jun-2013; the twenty-
four hour composite sample of treated effluent that was sampled between
08:00, 05-Jun-2013 and 08:00, 06-Jun-2013; and the twenty-four hour
composite sample of treated effluent that was sampled between 08:00, 06-
Jun-2013 and 08:00, 07-Jun-2013; the twenty-four hour composite sample
of treated effluent that was sampled between 08:00, 07-Jun-2013 and
08:00, 08-Jun-2013; the twenty-four hour composite sample of treated
2013; the twenty-four hour composite sample of treated effluent that was
08:00, 11-Jun-2013 and 08:00, 12-Jun-2013; the twenty-four hour
08:00, 01-Jul-2013; the twenty-four hour composite sample of treated
effluent that was sampled between 08:00, 01-Jul-2013 and 08:00, 02-Jul-
2013; and the twenty-four hour composite sample of treated effluent that
was sampled between 08:00, 02-Jul-2013 and 08:00, 03-Jul-2013.
Details of when incident On the morning of Wednesday, 15-May-2013.
first noticed:
Still ongoing: Yes/No Yes, however corrective action was instigated on the morning of
Wednesday, 15-May-2013. The forward flow through the affected clarifier
Finish time and date has been reduced to aid settlement. The companys WWTP consultants
have also been on-site and are currently trying to optimise the use of
polymers to further aid settlement. A number of corrective actions have
been implemented and these are outlined below.
New or reoccurring This is a new incident. The last time that there were settlement problems
incident1 with in the final stage of wastewater treatment was in February of 2013.
Note that one of the companys two Clarifiers is off-line for essential
inspection and maintenance and that this may have affected the overall
pattern of settlement.
Update 17-Jun-2013: The second of the two clarifiers is due to undergo
hydraulic testing on 18-Jun-2013 with a view to being returned to an
operational state (in conjunction with one of the other WWTP aeration
basins).
Update 19-Jun-2013: The second of the two clarifiers has successfully
undergone hydraulic testing on 18/19-Jun-2013 with a view to being
returned to an operational state (in conjunction with one of the other
WWTP aeration basins).
Update: 15-Jul-2013: The phased reintroduction of aqueous process
wastewater streams has commenced; and this will proceed in steps over a
three week time period. Approximately two weeks of fully compliant
Update: 01-Aug-2013: Process related aqueous wastewater streams are now
being treated in one aeration basin that was reseeded with externally
sourced biomass. A second standby aeration basin is now going to be
reseeded with biomass from the same source. At this point in time there is
good underlying treatment of the streams and the quality of the treated
effluent in consistently in specification.
Uncontrolled release: Not an uncontrolled release.
Incident Nature Breach of ELV. Please refer to the data for COD and TSS in the section
(Explosion, Fire, Spillage, Odour, Breach after next. This COD is associated with the loss of biosolids from the
of ELV, Monitoring Equipment offline, WWTP and the underlying treatment process in the WWTP is not affected.
Trigger Level Reached, Uncontrolled
Note that the mass discharge of Total Suspended Solids was also non-
Release, Other specify)
compliant for the samples that were taken between 08:00, 16-May-2013
and 08:00, 17-May-2013; 08:00, 27-May-2013 and 08:00, 28-May-2013;
08:00, 30-May-2013 and 08:00, 31-May-2013; 08:00, 01-Jun-2013 and
08:00, 02-Jun-2013; 08:00, 02-Jun-2013 and 08:00, 03-Jun-2013; 08:00,
03-Jun-2013 and 08:00, 04-Jun-2013; 08:00, 04-Jun-2013 and 08:00, 05-
Jun-2013; and 08:00, 06-Jun-2013 and 08:00, 07-Jun-2013.
Details of any vulnerable No vulnerable receptors.
receptors
Details of ELV Exceedance Parameter COD COD COD COD COD COD COD
if available2
(Provide measurement units for values Value 1,154 1,324 991 907 729 1,467 1,321
provided) mg/l mg/l mg/l mg/l mg/l mg/l mg/l
(COD: emission limit value: 700 mg/l and Value 565 636 674 553 328 381 436
a controlled discharge amount of 630 kgs)
kgs kgs kgs kgs kgs kgs kgs
Date 15- 16- 17- 18- 19- 20- 21-
May- May- May- May- May- May- May-
2103 2013 2013 2013 2013 2013 2013
Parameter COD COD COD COD COD COD COD
Value 1,399 946 583 614 688 806 867

mg/l mg/l mg/l mg/l mg/l mg/l ml/l
Value 532 445 315 295 289 322 624
Date 22- 23- 24- 25- 26- 27- 28-
2103 2013 2013 2013 2013 2013 2013
Value 1,025 1,410 1,290 1700 1750 1440 1740

mg/l mg/l mg/l mg/l mg/l mg/l mg/l
Value 543 649 490 680 682 562 696
Date 29- 30- 31- 01- 02- 03- 04-
May- May- May- Jun- Jun- Jun- Jun-
2103 2103 2013 2013 2013 2013 2013
Value 1630 1153 1273 796 891 731 580

Value 880 426 636 239 437 329 191
Date 05- 06- 07- 08- 09- 10- 11-
Jun- Jun- Jun- Jun- Jun- Jun- Jun-
2013 2013 2013 2013 2013 2013 2013
Value 718 788 969 1,028 979 1,075 1,100

Value 330 355 397 411 303 366 451
Date 12- 13- 14- 15- 16- 17- 18-
2013 2013 2013 2013 2013 2013 2013
Value 1,120 1,027 837 482 506 505 495

Value 459 401 243 164 162 162 188
Date 19- 20- 21- 22- 23- 24- 25-
2013 2013 2013 2013 2013 2013 2013
Value 398 322 490 779 1,112 1,165 1,084

Value 127 77 74 101 156 151 184
Date 26- 27- 28- 29- 30- 01- 02-
Jun- Jun- Jun- Jun- Jun- Jul- Jul-
2013 2013 2013 2013 2013 2013 2013
Value 713 622 544 390 257 249 532

Value 185 311 245 199 118 137 330
Date 03- 04- 05- 06- 07- 08- 09-
Jul- Jul- Jul- Jul- Jul- Jul- Jul-
2013 2013 2013 2013 2013 2013 2013
Value 429 129 226 204 135 110 128

Value 330 66 104 122 76 54 87
Date 10- 11- 12- 13- 14- 15- 16-
Jul- Jul- Jul- Jul- Jul- Ju- Jul-
2013 2013 2013 2013 2013 2013 2013
Value 296 338 73 38 47 73 94

Value 110 132 28 18 16 29 45
Date 17- 18- 19- 20- 21- 22- 23-
2013 2013 2013 2013 2013 2013 2013
Value 28 31 39 44 32 24 18
Value 14 15 20 24 17 14 11
Date 24- 25- 26- 27- 28- 29- 30-
2013 2013 2013 2013 2013 2013 2013
Parameter COD
Value 29
mg/l
Value 18
kgs
Date 31-
Jul-
2013
Details of ELV Exceedance Parameter TSS TSS TSS TSS TSS TSS TSS
if available2
(Provide measurement units for values Value 360 456 416 112 172 345 464
provided) mg/l mg/l mg/l mg/l mg/l mg/l mg/l
(TSS emission limit value of 500 mg/l and Value 176 219 283 68 77 90 153
a controlled discharge amount of 225 kgs)
Date 15- 16- 17- 18- 19- 20- 21-
2013 2013 2013 2013 2013 2013 2013
Parameter TSS TSS TSS TSS TSS TSS TSS
Value 468 232 152 228 198 298 372

Value 178 109 82 109 83 119 268
Date 22- 23- 24- 25- 26- 27- 28-
2013 2013 2013 2013 2013 2013 2013
Value 408 460 640 464 715 630 665

Value 216 212 243 186 279 239 266
Date 29- 30- 31- 01- 02- 03- 04-
May- May- May- Jun- Jun- Jun- Jun-
2103 2103 2013 2013 2013 2013 2013
Value 535 346 505 310 290 285 176

Value 289 128 253 93 142 128 58
Date 05- 06- 07- 08- 09- 10- 11-
2013 2013 2013 2013 2013 2013 2013
Value 304 330 310 480 355 390 480

Value 140 149 127 192 110 133 197

Date 12- 13- 14- 15- 16- 17- 18-

2013 2013 2013 2013 2013 2013 2013
Value 422 330 290 92 84 78 120

Value 173 129 84 31 27 25 kgs 46

kgs kgs kgs kgs kgs kgs
Date 19- 20- 21- 22- 23- 24- 25-

2013 2013 2013 2013 2013 2013 2013
Value 70 63 105 255 470 500 544

Value 22 15 16 33 66 65 kgs 92
Date 26- 27- 28- 29- 30- 01-Jul- 02-

Jun- Jun- Jun- Jun- Jun- 2013 Jul-
2013 2013 2013 2013 2013 2013

Value 296 300 168 102 28 54 256
Value 77 150 76 52 28 54 kgs 159

Date 03- 04- 05- 06- 07- 08-Jul- 09-

Jul- Jul- Jul- Jul- Jul- 2013 Jul-
2013 2013 2013 2013 2013 2013
Value 246 46 160 79 11 11mg/l 56

mg/l mg/l mg/l mg/l mg/l mg/l
Value 176 23 74 47 6 kgs 5 kgs 38

kgs kgs kgs kgs kgs
Date 10- 11- 12- 13- 14- 15-Jul- 16-

2013 2013 2013 2013 2013 2013
Value 102 109 59 11 <10 <10 54

Value 38 43 23 5 kgs 4 kgs 4 kgs 26

kgs kgs kgs kgs
Date 17- 18- 19- 20- 21- 22-Jul- 23-
2013 2013 2013 2013 2013 2013
Value < 10 10 10 <10 <10 <10 14

Value <5 5 kgs 5 kgs 5 kgs 5 kgs 6 kgs 8 kgs

kgs
Date 24- 25- 26- 27- 28- 29-Jul- 30-
2013 2013 2013 2013 2013 2013
Parameter TSS
Value 10
mg/l
Value 6 kgs
Date 31-
Jul-
2013
Grab or Composite sample Composite samples.
Location of incident: Emission Point Reference Number 100.
Wastewater Treatment Plant.
Discharge point/Other
Digital Photographs taken: No.
Odour3 No.
Odours detected No.
Extent4 Intermittent Persistent
Sensitivity5 Remote Low Moderate High Extra
Intensity6 Faint Moderate Strong Very strong
Weather at time of incident: Clear sky.
Wind Direction: Blowing from the West/north-West.
Details of who was notified: EPA by telephone Yes.
Local Authority Yes.
Fisheries Yes.
Other
Corrective actions taken: The forward flow through the affected clarifier has been reduced to aid
settlement. The companys WWTP consultants have also been on-site and
are currently trying to optimise the use of polymers to further aid
settlement.
Forward feed is now at minimum rate consistent with maintaining

adequate ullage in the equalisation tank (13 m3/h). This will be reviewed
again in the morning.
1 tonne of Nutrifeed M was added to the operational aeration basin to
boost inorganics and aid settlement (as per yesterday).
Biomass booster added to the operational aeration basin at 14:00 today.
Additions to continue for the next three days.
Forward feed is now split so that approximately half of the forward feed
will be diverted to a holding basin. This is to give the biomass a better
opportunity to return to a state of good settlement.
Nutrifeed M will continue to be added to the operational aeration basin to
boost inorganics and aid settlement over the weekend.
Additional Biomass booster will be added to the operational aeration basin
over the next two days.
Additional phosphoric acid will be added to boost the nutrients available
to the existing and new biomass.
A sample of the treated effluent will be analysed for particle size
distribution. The test, which can take up to four days to complete, will be
used to evaluate the options for use of a mobile filter if good settlement is
not restored in the coming days.
A sample of the influent waste streams will be analysed for respiratory
inhibition (note that there appears to be good biological removal of COD
within the treatment process at this point in time).

Pending the availability of particle size test results on the solids in the
treated effluent some preparatory work is to be undertaken to facilitate the
installation of an on-line filter after the effluent passes through the
operational clarifier and before the composite sampler. The particle size
analysis result is anticipated to be available on Tuesday 21-May-2013.
The concentration of the influent COD to the WWTP has decreased
significantly over the past two months from approximately 7,000 mg/l to
3,500 mg/l COD. There is good uptake of the available COD in the
treatment plant and from today it is proposed to bring the concentration of
the influent COD up to approximately 5,000 mg/l. It may be that the
relatively low input of COD may be having an adverse effect on the
WWTPs biomass in respect of its settlement profile.
An additional mechanical walk-down of the WWTP is to be undertaken
today to ensure that no blockages, air pockets etc. are being overlooked.
The concentration of the influent COD to the WWTP has been increased
over the past twenty-four hours to approximately 5,000 mg/l by the
addition of a supplementary mixture of water and Ethyl Acetate. This will
be maintained over the coming days. This action does appear to have
stimulated additional metabolic activity in the biological section of the
WWTP and may play a role in promotion of a biomass with a better
settlement profile.
The possibility of adding an external source of biomass to the biological
section of the WWTP is under review. A number of potential sources have
been identified; and a decision on implementing this measure will only be
taken after two days to three days of maintaining an influent wastewater
with a COD of approximately 5,000 mg/l.
The particle size analysis of the treated effluent is still under determination
in a specialist laboratory in the United Kingdom.
One tonne of Ferric Chloride has been added to the biological section of
the WWTP after recent jar tests indicated that it was having a beneficial
effect in terms of clarifying the treated effluent.
A filter housing unit has been put in line with the treated effluent
discharge from the clarifier in the WWTP. This unit, which holds a 100
micron filter, is upstream of the composite sampler at Emission Point
Reference Number 100. The performance of this unit will be evaluated on
23-May-2013.
The decision on the use of an external source of biomass has been deferred
pending an evaluation of the use of the filter housing unit and the addition
of Ferric Chloride.
The addition of Ferric Chloride has had a positive effect on promotion of

better settlement of the biomass in the clarifier. A grab sample of treated
effluent that was taken at 09:00 on 23-May-2013 indicates an effluent with
a COD of 588 mg/l and a TSS of 166 mg/l; and a potentially compliant
sample for the period of 08:00, 23-May-2013 to 08:00, 24-May-2013 (to be
confirmed tomorrow).
The addition Ferric Chloride will be continued over the coming days to
enable better settlement of the biomass.
The 100 micron filter housing unit did not have any appreciable effect on
solids removal and a filter with a smaller pore size of 20 microns is being
trialed today.
The target influent COD concentration of 5,000 mg/l will be maintained
over the coming days at it would appear to have promoted better biological
activity within the one operational aeration basin.
Update: 24-May-2013:
The addition of Ferric Chloride has had a positive effect on promotion of

better settlement of the biomass in the clarifier. The twenty-four hour
May-2013 and 08:00, 24-May-2013 was compliant both for COD with a
reading of 583 mg/l (mass discharge of 315 kgs); and TSS with a reading of
152 mg/l (mass discharge of 82 kgs). A grab sample of treated effluent that
was taken at 09:00 on 24-May-2013 indicates continuing improvement and
an effluent with a COD of 127 mg/l and a TSS of 49 mg/l (and a second
potentially compliant sample for the period of 08:00, 24-May-2013 to
08:00, 25-May-2013).
The addition Ferric Chloride will be continued over the weekend to enable
better settlement of the biomass.
The 20 micron filter housing unit did not have any appreciable effect on
solids removal and a filter with a smaller pore size of 1.5 microns is being
trialed today (as a back-up to the use of Ferric Chloride).
The target influent COD concentration of 5,000 mg/l will be maintained
over the coming days at it would appear to have promoted better biological
activity within the one operational aeration basin.
Additional inorganic material was added to aid flocculation once the trend
towards elevated TSS in the treated effluent was identified.
The 1.5 micron filter housing unit did not have any appreciable effect on
solids removal and a filter with a smaller pore size of 1 micron is currently
being sourced.
A number of cleaning agents used in various parts of the facility are to be
removed from the influent wastewater streams to the WWTP as a
precautionary measure. These are bacterial disinfectants used in relatively
small amounts.
A twice daily cleaning regime is to be implemented on the oxygen probe

in the operational aeration basin as the air input to the aeration basin is
more variable than what would be expected from organic content of the
influent wastewater streams to the WWTP.
A filter with a smaller pore size of 1 micron is currently being installed (as
a back-up to the use of Ferric Chloride). Note that this is a relatively small
pore size and gives some indication as to the small size of the pin-flocs of
biomass that are causing the current problem.

Agreement was reached on-site to stop all of the main process related
aqueous wastewater streams entering the WWTP. A further meeting is
scheduled for 30-May-2013 to identify alternative treatment options for
these wastewater streams.
Agreement was reached on-site to divert all of the main process related
aqueous wastewater streams away from the WWTP until such time as the
WWTP can be returned to a sustainable compliant state of operation. These
streams will be routed for off-site treatment on an interim basis. The other
main streams currently entering the WWTP include the inputs from the
sites sanitary system and utility related operations such as boiler
blowdowns and blowdowns from water purification systems.
Confirmation was received from all of the Production Units on-site that
the main process related aqueous wastewater streams have been diverted
away from the WWTP until such time as the WWTP can be returned to a
sustainable compliant state of operation.
A monitoring plan has been put in place for the forthcoming weekend to
track changes arising from the removal of the main process related aqueous
wastewater streams from the influent waste streams. This will be important
as the biological section of the WWTP will require some supplementary
feed until such time as it is restored to a normal operating condition.
Aqueous waste streams continue to be diverted away from the WWTP

until such time as the WWTP can be returned to a sustainable compliant
state of operation.
Daily meetings held over the Bank Holiday weekend (01-Jun-2103 to 03-
Jun-2103) between Operations and site HSE to keep abreast of the situation
to ensure that agreed actions continue to be implemented
In consultation with our consultants (ENVA), an evaluation is being
performed on the existing biomass and its likely rate of recovery.
Examining options to revive WWTP by transfer in of external biomass to
the aeration basin. (source to be determined)
ENVA carrying out pilot plant testing at present to ascertain the most
effective option.

state of operation.
The aeration basin is showing signs of recovery as indicated by filtered
COD sample. Results of a polytox test carried out by ENVA have shown a
significant increase in the oxygen uptake of the plant.
Pilot plant testing by ENVA has identified a potential biomass from a local
biopharmaceutical plant will enhance the recovery of the WWTP
The next site formal incident review meeting will be held on 06-Jun-2013.

state of operation.
The overall health of the WWTP is showing signs of improvement as can
be seen from the results in the Details of the ELV Exceedance section of
this document.
Biomass from a neighbouring pharmaceutical facility WWTP will be used
to supplement the recovery of the aeration basins. Initially 40 tonnes will be
added to the aeration basin on 07-Jun-2013 with an additional 60 tonnes to
be added over 10-Jun-2013 and 11-Jun-2013.

state of operation.
Commenced transfer in of biomass (34 tonnes) from neighbouring
pharmaceutical API facility to supplement the recovery of the aeration
basin.
WWTP is being allowed to settle over the weekend and transfer in of
biomass (66 tonnes) from neighbouring pharmaceutical API facility will re-
commence on Monday 10-Jun-2013.

state of operation.
A significant improvement has been noticed in the TSS and COD figures.
Transfer in of biomass (34 tonnes) from neighbouring pharmaceutical API
facility has continued on 10-Jun2013.
It is planned to transfer in a further 32 tonnes of biomass in the latter half
of this week.

state of operation.
The twenty-four hour composite sample of treated effluent that was
sampled between 08:00, 10-Jun-2013 and 08:00, 11-Jun-2013 was
compliant both for COD with a reading of 580 mg/l (mass discharge of 191
kgs); and TSS with a reading of 176 mg/l (mass discharge of 58 kgs).
We will assess the plant over next week prior to the reintroduction of
process streams.
It is planned to transfer in a further 32 tonnes of biomass in the latter half
of this week.

state of operation
We will continue to monitor the recovery of the plant and adjust the
addition of feed to maintain optimum MLSS at 5000 mg/l in the aeration
basin.

state of operation
basin.

state of operation.
basin.
The plant will be monitored over the weekend with samples being taken
and analysed by ENVA and reported daily to relevant Site Heads
A number of additional corrective actions were agreed on 17-Jun-2013:
Preparations are now underway on-site to reactivate one of the WWTPs

other aeration basins and the one other clarifier, which was off-line for
inspection and maintenance.
combination of aeration basin and clarifier will be started in parallel to the
currently operational aeration basin and clarifier; and will be seeded with
biomass sourced externally.
Final hydraulic testing of the aeration basin that is to be reactivated; and
the clarifier that was off-line for inspection and maintenance will take place
on Tuesday 18-Jun-2013.
A number of (continuing and) additional corrective actions were agreed on

18-Jun-2013:
Preparations are now underway on-site to reactivate one of the WWTPs

other aeration basins and the one other clarifier, which was off-line for
inspection and maintenance.
biomass sourced externally. Confirmation of the source will be made on
Wednesday 19-Jun-2013.
the clarifier that was off-line for inspection and maintenance is currently
taking place (Tuesday 18-Jun-2013).
19-Jun-2013:

the clarifier that was off-line for inspection and maintenance has been
completed.
Preparations are now underway on-site to reseed one of the WWTPs other
aeration basins and make the one other clarifier, which was off-line for
inspection and maintenance, operational.
biomass sourced externally. It is hoped to deliver the first batch of this
biomass on Thursday.

20-Jun-2013:
Operations are now underway on-site to reseed one of the WWTPs other
biomass sourced externally. The first batch of this biomass is currently
being introduced to the aeration basin and this will be bulked up under
controlled conditions over the coming days.

21-Jun-2013:
Operations are now continuing on-site to reseed one of the WWTPs other
biomass sourced externally. The first batch of this biomass was introduced
to the aeration basin on Thursday 20-Jun-2013; and additional material is
currently being added on Friday 21-Jun-2013. This will be bulked up under
inspection and maintenance, operational. The aeration basin in question is
now approximately half-full. Externally sourced biomass was added to this
basin on Thursday 20-Jun-2013; and Friday 21-Jun-2013. No further
additions are anticipated and the plan is to bulk this material up under
now approximately half-full. Externally sourced biomass was added to this
basin on Thursday 20-Jun-2013; and Friday 21-Jun-2013. No further
additions are anticipated and the plan is to bulk this material up under
controlled conditions over the coming days. Note that four consecutive
twenty-four hour composite samples have returned compliant results over
the past four days.
now approximately three-quarters full. Externally sourced biomass was
added to this basin on Thursday 20-Jun-2013; and Friday 21-Jun-2013. No
further additions are anticipated and the plan is to bulk this material up
under controlled conditions over the coming days. Note that five
consecutive twenty-four hour composite samples have returned compliant
results over the past four days.
As part of this work forward feed (less the production aqueous waste
streams that have been diverted away from the wastewater treatment plant)
is being introduced to this aeration basin at a rate of approximately 2
m3/hour together with some sanitary wastewater. This will help increase
the residence time in the one operational aeration basin and help progress
towards a stable and compliant operation.
Six consecutive days of compliant readings for the discharge of COD and
TSS have been notified to the EPA since Saturday 22-Jun-2013. While
there has been a recovery in the operational aeration basin it still isnt at a
stage where process wastewater streams can be reintroduced to the
Wastewater Treatment Plant (WWTP). The EPA will continue to be
updated on a daily basis until such time as routine treatment of process
wastewater streams resumes at the facility.
now nearly full; and will commence overflowing to the recently serviced
clarifier in the coming day or two.
Externally sourced biomass was added to this basin on Thursday 20-Jun-

2013; and Friday 21-Jun-2013. No further additions are anticipated and the
plan is to bulk this material up under controlled conditions over the coming
days. It may be possible to consider the phased reintroduction of process
wastewater streams from the end of next week depending on the growth
curve of this new biomass.
As part of this reseeding work forward feed (less the production aqueous
waste streams that have been diverted away from the wastewater treatment
plant) is being introduced to this aeration basin at a rate of approximately 4
the residence time in the one operational aeration basin possibly help to
promote a more stable biomass in that basin.
now full and has commenced overflowing to the recently serviced clarifier,
which will now fill over the coming days.
Externally sourced biomass was added to this basin on Thursday 20-Jun-

2013; and Friday 21-Jun-2013. No further additions are anticipated and the
plan is to bulk this material up under controlled conditions over the coming
days. It may be possible to consider the phased reintroduction of process
wastewater streams from the end of this week depending on the growth
curve of this new biomass.
which is now nearly full and is anticipated to start discharging later today
or tomorrow.
It may be possible to consider the phased reintroduction of process

curve of this new biomass; and the compliance status of the treated effluent.
which is now full and is slowly overflowing to the treated effluent
discharge line
It may be possible to consider the phased reintroduction of process

promote a more stable biomass in that basin. It is anticipated that the feed
rate of will be slowly increased over the coming days as this aeration basin
takes more of the forward feed, which is made up primarily of sanitary
wastewater and utility related blowdowns.
discharge line.
A decision on the phased reintroduction of process wastewater swill now

be deferred until next week and will depend on the growth curve of this
new biomass; and the compliance status of the treated effluent.
discharge line. This has resulted in an improvement in the quality of the
treated effluent leaving the site.

be deferred until next week and will depend on the growth curve of this
new biomass; and the compliance status of the treated effluent.
m3/hour together with some sanitary wastewater. This process will
continue during the coming week as more of the site load is transferred on
to this aeration basin.
now nearly fully operational and forward feed (less the production aqueous
plant) is being introduced to this aeration basin at a rate of approximately
10 m3/hour together with some sanitary wastewater. This process will
to this aeration basin.

be deferred until the end of the current week and will depend on the growth
now nearly fully operational and forward feed (less the production aqueous
plant) is being introduced to this aeration basin at a rate of approximately
10 m3/hour together with some sanitary wastewater. This process will
to this aeration basin. A decision on the phased reintroduction of process
wastewater will now be made at the end of the current week.
now fully operational and forward feed (less the production aqueous waste
Most of the sites load has now been transferred on to this aeration basin. A
decision on the phased reintroduction of process wastewater will be made
at the end of the current week.
now fully operational and forward feed (less the production aqueous waste
Most of the sites load has now been transferred on to this aeration basin. A
decision on the phased reintroduction of process wastewater will be made
at the end of the current week. Note that eight consecutive days of
Operations have now been completed on-site to reseed one of the

WWTPs other aeration basins and make the one other clarifier, which was
off-line for inspection and maintenance, operational. The aeration basin in
question is now fully operational and forward feed (less the production
aqueous waste streams that have been diverted away from the wastewater
treatment plant) is being introduced to this aeration basin at a rate of
approximately 10 m3/hour together with approximately half of the sites
sanitary wastewater. Most of the sites load has now been transferred on to
this aeration basin. A decision on the phased reintroduction of process
wastewater streams will be made at the start of the coming week. Note that
nine consecutive days of compliant readings have been recorded at this
point in time.
Operations have now been completed on-site to reseed one of the

WWTPs other aeration basins and make the one other clarifier, which was
off-line for inspection and maintenance, operational. The aeration basin in
question is now fully operational and forward feed (less the production
aqueous waste streams that have been diverted away from the wastewater
treatment plant) is being introduced to this aeration basin at a rate of
approximately 10 m3/hour together with approximately half of the sites
sanitary wastewater.
Most of the sites load has now been transferred on to this aeration basin.
The phased reintroduction of process wastewater streams has now
commenced and these will be brought back on-line over a three week
period. Note that twelve consecutive days of compliant readings have been
recorded at this point in time.
Planning has also commenced to fully reseed another aeration basin using
externally sourced biomass in the coming weeks.
A number of continuing corrective actions are on-going as of 16/17-Jul-

2013:
Most of the sites load has now been transferred on to the aeration basin
that was reseeded over the past number of weeks using externally sourced
biomass. The phased reintroduction of process wastewater streams has now
commenced and these will be brought back on-line over a three week
period. Note that two weeks of compliant readings have been recorded at
this point in time.
A number of continuing corrective actions are on-going as of 22/23-Jul-

2013:
Most of the sites load has now been transferred on to the aeration basin
that was reseeded over the past number of weeks using externally sourced
biomass. The phased reintroduction of process wastewater streams has been
on-going for over one week; and these will be brought back on-line over
another two week period. Note that approximately three weeks of
A number of continuing corrective actions are on-going as of 24/25/26-Jul-

2013:
The sites load has now been transferred on to the aeration basin that was
reseeded over the past number of weeks using externally sourced biomass.
The phased reintroduction of process wastewater streams has been on-
going for two weeks; and these will be brought back on-line over another
two week period. Note that over three weeks of compliant readings have
been recorded at this point in time.
externally sourced biomass during the coming week. This aeration basin
will be used as a back-up to the one that is now currently functioning to
specification.
A number of continuing corrective actions are on-going as of 29/30/31-Jul-

2013:
The sites load has now been transferred on to the aeration basin that was
reseeded over the past number of weeks using externally sourced biomass.
The phased reintroduction of process wastewater streams has been on-
going for three weeks; and is now complete. Note that four weeks of
The reseeding of another aeration basin using externally sourced biomass

has now commenced. This aeration basin will be used as a back-up to the
one that is now currently functioning to specification. The biomass that will
On-Site Incineration Record Summary 2013:
Emission Point Reference Number 3 (Solid Waste Incinerator)
EWC Code Waste Material Description Quantity Incinerated (kgs)
07 05 01 (*) Aqueous washing liquids and other liquors 0

07 05 04 (*) Other organic solvents, washing liquids and mother 0
liquors
07 05 10 (*) Other filter cakes and spent absorbents 363.10
07 05 13 (*) Solid wastes containing dangerous substances 2,555.87
15 01 01 Paper and cardboard packaging 0
15 01 02 Plastic packaging 147.28
15 01 03 Wooden packaging 32.52
15 01 06 Mixed packaging 450.72
15 01 10 (*) Packaging containing residues of or contaminated by 28,395.77
dangerous substances
15 02 02 (*) Absorbents, filter materials (including oil filters not 29,020.06
otherwise specified), wiping cloths, protective clothing
contaminated by dangerous substances
15 02 03 Absorbents, filter materials, wiping cloths and 1,448.15
protective clothing other than those
mentioned in 15 02 02
16 03 05 (*) Organic wastes containing dangerous substances 4.91
16 05 06 (*) Laboratory chemicals, consisting of or containing 13,067.46
dangerous substances, including mixtures of
laboratory chemicals
Total Quantity Incinerated 2013 (tonnes): 75.486
Note that a total of 31,143 kgs of fibreboard drums were incinerated (primarily under the other codes as waste containers). The 2013 total also
includes 443 kgs of plastic drums. A total of 16,062 plastic bags were also incinerated (as waste containers)
On-Site Incineration Record Summary 2013:
Emission Point Reference Number 4 (Liquid Vapour Incinerator)
EWC Code Waste Material Description Quantity Incinerated (Tonnes)
07 05 01 Aqueous washing liquids and other liquors 359.221

07 05 04 Other organic solvents, washing liquids and mother liquors (Liquid 1,984.747
waste)
07 05 04 Gaseous wastes containing organic and inorganic gases (Vapour 372.119
waste)
Total Quantity Incinerated 2013: 2,716.087

Section 3: Management of the Activity:
Environmental Expenditure Summary: Capital and Current
Environmental Management Programme - Proposal
Environmental Management Programme - Report
European Pollutant Release and Transfer Register (PRTR) Report for

2013
Schedule of Environmental Objectives and Targets - 2013 (Update)
Schedule of Environmental Objectives and Targets - 2014

Environmental Expenditure Summary: Capital and Current Expenditure 2013
Capital expenditure for environmental protection 2013: 3,390,370
Current expenditure for environmental protection 2013: 13,400,807
Fulltime employees for environmental protection 2013: 20

Environmental Management Programme
(Eighteenth Revision)
01-Apr-2014
This site has an Environmental

Management System and its environmental
performance is reported on to the public in
accordance with the Community Eco-
Management and Audit Scheme.
(Registration Number IE - 002)

Novartis Ringaskiddy Limited_________Environmental Management Programme (2014)
Novartis Ringaskiddy Limited and Responsible Care
As a member of the PharmaChemical Ireland group Novartis

Ringaskiddy Limited strongly supports the unique initiative
developed by the international chemical industry, called
RESPONSIBLE CARE, and is fully committed to the set of health,
safety and environment Guiding Principles drawn up under
Responsible Care by PCI.
Accordingly, Novartis Ringaskiddy Limited is committed to

"managing its activities so that they present an acceptably high
level of protection for health and safety of employees, customers,
the public and the environment", and in doing so will "work closely
with public and statutory bodies".
But more than this, since the underlying philosophy of Responsible

Care is very much focused on continuous improvement of the
performance of the chemical industry in every aspect, Novartis
Ringaskiddy Limited is already voluntarily committed to the principle
of environmental improvement
on a continuous planned basis.
ii
List of Abbreviations Used Frequently in the Text of this Document:
% Percent
AER Annual Environmental Report
BOM Bill of Material
CEM Continuous Emission Monitor
CIP Cleaning In Place
DCS Distributed Control System
EC European Community
EEC European Economic Community
EIS Environmental Impact Statement
ELV Emission Limit Value
EMAS Eco-Management and Audit Scheme
EMP Environmental Management Programme
EPA Environmental Protection Agency
E-PRTR European Pollutant Release and Transfer Register
ESB Electricity Supply Board
HSA Health and Safety Authority
HSE Health, Safety and Environmental Protection
HVAC Heating, Vacuum and Air Conditioning
IED Industrial Emissions Directive
IEL Inductrial Emissions Licence
IDA Industrial Development Authority
IPCL Integrated Pollution Control Licence
IPPCL Integrated Pollution Prevention and Control Licence
kg Kilogramme
LVI Liquid Vapour Incinerator
m3 Cubic metre
PB1 Production Building 1
PB1A Production Building 1A
PB2 Production Building 2
SEI Sustainable Energy Ireland
SOP Standard Operating Procedure
SWI Solid Waste Incinerator
TALAS T.A. Luft Analytical System
TOC Total Organic Carbon
iii
Page Number
List of Abbreviations iii
Table of Contents iv
1.0 INTRODUCTION 1
2.0 EIGHTEENTH REVISION TO SITE ENVIRONMENTAL MANAGEMENT PROGRAMME 4
3.0 ENVIRONMENTAL STATEMENT 2010 to 2012 8
4.0 MANAGEMENT OF THE ACTIVITY 11
4.1 Process Modifications Resulting in Improved Yields, 12

Elimination or Reduction of Wastes or the Use of Alternative
Less hazardous Materials
4.1.1 Site Waste Management Group 13
4.1.2 Electronic Waste Tracking System 13
4.1.3 Off-Site Reuse of Inert Adsorbent 14
4.1.4 Biodegradable Sludge Management 14
4.1.5 Installation of Weigh Bridge 14
4.1.6 Diversion of Spent Lime and Activated Carbon 15

to Beneficial Reuse
4.1.7 New Segregation System for Non-Hazardous Waste 16
4.1.8 New Source Segregation of Biodegradable/Compostable Waste 16
4.1.9 Reclassification of Bottom Ash and Slag 17
4.2 Improved Process Control (Equipment and Management) 17

to Reduce Waste
4.2.1 Automation in Process Control 17
4.2.2 Sequence of Use of Automation in Production 17
4.3 Improvements in Equipment Cleaning Procedures 17

Resulting in Reduced Materials Usage or Alternative
Materials Usage
4.4 Maintenance and Calibration of Key Control and Monitoring Equipment 18
4.4.1 Maintenance and Calibration of Key Atmospheric Emissions 18

Abatement/Treatment Control Equipment
4.4.2 Maintenance and Calibration of Key Atmospheric Emissions 18

Abatement/Treatment Monitoring Equipment
4.4.3 Maintenance and Calibration of Key Sewer Emissions 19
iv
4.4.4 Maintenance and Calibration of Key Sewer Emissions 19

4.5 Improvements in Treatment/Abatement Systems to Reduce Emissions 19
4.5.1 Improvements Proposed for the Solid Waste Incinerator 20
4.5.2 Improvements Proposed for the Liquid Vapour Incinerator 21
4.5.3 Improvements Proposed for the Wastewater Treatment Plant 22
4.5.4 Improvements Proposed for the Main Production Buildings 24
4.6 The Use of Alternative Treatment/Abatement Systems 25
4.6.1 Redundancy Option on Liquid Vapour Incinerator 25
4.6.2 Wet Electrostatic Precipitator Option on Liquid Vapour Incinerator 25
4.6.3 Scrubbing Option On Redundant Vapour Treatment Module 25
4.7 Recovery, Reuse, Recycling of Waste Material Both On-Site and Off-Site 25
4.7.1 Solvent Reuse and Recycling 25
4.7.2 Metal Recycling 26
4.7.3 Installation of Recycling Point 26
4.7.4 Reuse of Inert Adsorbent Material 27
4.7.5 Recycling of Waste Oil 27
4.7.6 Improved Segregation of Non-Hazardous Waste 27
4.8 Reduction in Fugitive Emissions 27
4.9 Prevention of Incidents with the Potential for Environmental 28

Consequences and the Preparation and Implementation of
Contingency Plans in the Event of an Incident
4.9.1 General Overview 28
4.9.2 Prevention of Incidents with the Potential for 28

Environmental Consequences
4.9.3 Hazard Potential of Chemicals in use at 29

4.9.4 Preparation and Implementation of Contingency Plans 29

in the Event of an Incident
4.10 Savings in Energy and Materials Usage 30
4.10.1 Savings in Energy Usage 30
v
4.10.2 Savings in Materials Usage 34
4.11 Prevention of Emissions of Carcinogenic Substances 34
4.12 Relevant Employee Training 36
4.13 Novartis Ringaskiddy Limited: Pollutant Release and Transfer Register 36
4.14 Novartis Ringaskiddy Limited: Public Information 38

on Environmental Activities
4.15 Sound Level Survey 38
4.16 Programme for Reduction in Sound Level Emissions 38

from Specified Sources
4.17 Programme for the Protection of Surface Water 39
4.17.1 General Overview 39
4.17.2 Warning and Action Levels 39
4.17.3 Reference Drawing Numbers 39
4.17.4 Improvements Proposed for the Surface 39

Water Protection System
4.18 Groundwater Quality and Identification of Contamination 41
5.0 EXPECTED RESULTS OF THE NOVARTIS RINGASKIDDY LIMITED 43

ENVIRONMENTAL MANAGEMENT PROGRAMME
5.1 General Comments 43
5.2 Emissions from Production and Chemical Storage Equipment 43
5.3 Compliance with Industrial Emissions Licence 45

Register Number P0006-03
5.4 Expected Progress 2014 46
Schedule of Objectives for 2014 46
6.0 REFERENCES 48
vi
1.0 INTRODUCTION
Novartis AG provides innovative healthcare solutions that address the evolving needs of patients and
societies. Headquartered in Basel, Switzerland, Novartis offers a diversified portfolio to best meet these
needs: innovative medicines, eye care, cost-saving generic pharmaceuticals, preventive vaccines and
diagnostic tools, over-the-counter and animal health products. Novartis is the only global company with
leading positions in these areas. In 2013, the Group achieved net sales of USD 57.9 billion, while
Research and Development throughout the Group amounted to approximately USD 9.9 billion (USD 9.6
billion excluding impairment and amortization charges). Novartis Group companies employ approximately
136,000 full-time-equivalent associates and operate in more than 140 countries around the world.
Further Group information is available at http://www.novartis.com.
Novartis in Ireland is involved in the distribution of medications and the manufacture of drug substances
for pharmaceuticals. Novartis Ringaskiddy Limited, the companys pharmaceutical production plant at
Ringaskiddy, County Cork, currently employs approximately 564 people and manufactures a wide range
of speciality drug substances used in the treatment of immunologic, dermatologic, cardiovascular,
oncological and central nervous system diseases. The company has currently developed about 30 ha of
what is now a 53 ha site for the manufacture and purification of a range of drug substances. The end
products are exported worldwide to formulation and packaging plants, for incorporation into forms
suitable for the end user (tablet, phial, etc.).
Novartis Ringaskiddy Limited is located on the western side of a large industrially zoned area in
Ringaskiddy, County Cork. Areas of mixed agriculture and a number of small villages including
Ringaskiddy itself border the industrial zone. Ringaskiddy has been developed over the past twenty-five
years into the deep-water berth for the Port of Cork; and further significant development of the port area
is planned in the coming years.
The design and construction of the facility at Ringaskiddy provided for the most up to date environmental
concepts. The ever improving approach over the course of the last century to environmental concepts
applied to chemical factories has reached a point with Novartis Ringaskiddy Limited where the factory
has central treatment for all process related activities and only one wastewater discharge point. This
permits accurate, and in many cases continuous, monitoring of emissions from the facility to the
environment.
Of further special note in this context is the fact that the wastewater treatment plant is fully enclosed and
that the air used in the treatment of wastewater is subsequently used as the combustion air for the
incinerator. This concept dramatically reduces emissions and avoids odours and also makes it possible to
measure accurately all emissions and discharges so that the highest standards of environmental
responsibility are set and maintained.
Resources such as solvents (liquids used for dissolving solids), paper, metal, biodegradable waste,
plastic and glass are recycled wherever economically practicable and solvent recovery units have been
installed to ensure that a high proportion of solvents can be recycled on-site.
1
Protection of surface water and groundwater has also been catered for in the design of the facility. All
surface water, for example, rain water or fire water, which falls on the site, is guided to a retention pond.
Water from this pond can only be released after testing has proved that it is not contaminated. If any
contamination is found, the water is pumped to the wastewater treatment plant for treatment prior to
discharge.
Novartis manufacturing facility in Ringaskiddy is comprised of three main production buildings, which are
known as Production Buildings 1, 1A and 2. A dedicated Small Scale Facility (SSF) has also been
developed at the facility. The SSF plant is located north of Production Building 1A. The SSF, which was
commissioned during 2008, was first used for the manufacture of certain low volume high value products
during 2009. Civil enabling works in respect of a proposed extension to Production Building 1A were
undertaken during 2013. However, at the time of writing it appears unlikely that the proposed extension
will now go ahead.
All production buildings are supported by a Technical Services Support Unit which supplies raw materials,
utility services and waste management services. The latter scope of work includes solvent recovery;
wastewater treatment; and air emission control. The facility also has a dedicated Health, Safety and
Environment (HSE) Support Unit, which is dedicated to maintaining full regulatory compliance in all
aspects of HSE.
The company shipped 270.236 tonnes of active drug substances in 2011; 441.870 tonnes of drug
substances in 2012; and 393.240 tonnes of drug substances in 2013. The relatively low volumes in 2011
were caused by a delay in the start-up of a new and more efficient production process for Diovan during
the first-quarter of 2011. This new efficient process ran for a full calendar years in 2012 and 2013 and
had a very positive impact on many of the environmental metrics that the company measures its progress
against.
The Environmental Protection Agency (EPA) regulates aspects of Novartis Ringaskiddy Limited's
operations that might impact on the environment. The company was issued with an Integrated Pollution
Prevention and Control Licence (IPPCL) by the Agency Register Number P0006-03 dated 02-Feb-
2006. This IPPCL superseded Integrated Pollution Control Licence (IPCL) Register Number 545, which
had been in force since 31-Oct-2000. The latter IPCL superseded the company's original IPCL (Register
Number 6), which was issued to the company by the EPA on 16-May-1995. IPPCL Register Number
P0006-03 introduced a number of new requirements for the company - some of which are addressed in
Section 4 of this document.
The Agency issued a technical amendment to the companys IPPCL on 30-Dec-2013, which had the
effect of bringing the licence into conformity Directive 2010/75/EU (Industrial Emissions Directive). The
register number of the companys licence remains the same P0006-03 but it is now referred to an
Industrial Emissions Licence (IEL) rather than an IPPCL.
The Agency also issued Novartis Ringaskiddy Limited with a Greenhouse Gas Emissions Permit (Permit
Register Number GHG078-1) on 29-Mar-2004. This permit was subsequently updated by the Agency on
23-Sep-2005 when Greenhouse Gas Emissions Permit (Permit Register Number IE-GHG078-2) was
issued; 12-Aug-2008 when Greenhouse Gas Emissions Permit (Permit Register Number IE-GHG078-3)
was issued; and 18-Jul-2013 when Greenhouse Gas Emissions Permit Register Number IE-GHG078-
10386-1 was issued.
2
Novartis Ringaskiddy Limited's site is also host to another Novartis company. Novartis International
Pharmaceutical Branch Ireland is part of a Novartis owned technology and proprietary company and is
responsible for controlling chemical production of bulk raw material on a global basis by Novartis Pharma
AG. It is comprised of quality control, logistics and quality assurance departments. Another of the
companys principal functions is the provision of assistance to Novartis various manufacturing sites in the
procurement of raw materials. This operation currently employs approximately 187 people. These
employees are housed in a single storey building that is comprised of an administration block and a
quality assurance/quality control service laboratory block.
Total numbers employed at the Novartis Ringaskiddy Campus have increased from 572 in 2011 to 751 in
2013.
Full details of the Novartis International Pharmaceutical Branch Ireland development have already been
forwarded to the EPA (correspondence of 24-Sep-1998, ref.: IPC10159.doc).
3
2.0 EIGHTEENTH REVISION TO SITE ENVIRONMENTAL
MANAGEMENT PROGRAMME
Novartis Ringaskiddy Limited was required, under Conditions 2.1 and 2.3; and Schedule 6 (i) of IPCL
Register Number 6, to submit its first Environmental Management Programme (EMP) to the EPA on 16-
Nov-1995. The EPA subsequently approved the aforementioned EMP on 19-Jan-1996 without any
changes. A report on the implementation of this EMP was forwarded to the EPA on 03-Feb-1997 in
accordance with the provisions of Schedule 6 (i) of the company's IPCL. This report was approved by the
Agency on 18-Feb-1997.
The company submitted its first annual revision to the site EMP, required under Schedule 6(i) of IPCL
Register Number 6, on 21-Nov-1996. This revision was approved by the Agency on 02-Dec-1996 without
any changes. A report on the implementation of the first revision was forwarded to the EPA on 11-Feb-
1998 in accordance with the provisions of Schedule 6 (i) of the company's IPCL.
Novartis Ringaskiddy Limited submitted its second annual revision to the site EMP, required under
Schedule 6(i) of IPCL Register Number 6, on 21-Nov-1997. This revision was approved by the Agency on
30-Dec-1997 without any changes. A report on the implementation of the second revision of the EMP
(covering the calendar year 1998) was forwarded to the EPA on 23-Feb-1999 in accordance with the
provisions of Schedule 6 (i) of the company's IPCL.
The company submitted its third annual revision to the site EMP, required under Schedule 6(i) of IPCL
Register Number 6, on 07-Dec-1998. A report on the implementation of the third revision of the EMP
(covering the calendar year 1999) was forwarded to the EPA on 10-Feb-2000 in accordance with the
provisions of Schedule 6 (i) of the company's IPCL.
The company submitted its fourth annual revision to the site EMP, required under Schedule 6(i) of IPCL
Register Number 6, on 15-Dec-1999. A report on the implementation of the fourth revision of the EMP
(covering the calendar year 2000) was submitted to the EPA as part of the company's Annual
Environmental Report (AER) for 2000.
In the intervening period IPCL Register Number 6, which was issued on 16-May-1995, was superseded
by IPCL Register Number 545 on 31-Oct-2000.
The company submitted its fifth annual revision to the site EMP, required under Schedule 5(i) of IPCL
Register Number 545, on 01-Feb-2001. A report on the implementation of the fifth revision of the EMP
(covering the calendar year 2001) was submitted to the EPA as part of the company's AER for 2001
(dated 01-Feb-2002).
The company submitted its sixth annual revision to the site EMP, required under Schedule 5(i) of IPCL
Register Number 545, on 01-Feb-2002. A report on the implementation of the sixth revision of the EMP
(covering the calendar year 2002) was submitted to the EPA as part of the company's AER for 2002
(dated 01-Apr-2003).
4
The company submitted its seventh annual revision to the site EMP, required under Schedule 5(i) of IPCL
Register Number 545, on 31-Mar-2003. A report on the implementation of the seventh revision of the
EMP (covering the calendar year 2003) was submitted to the EPA as part of the company's AER for 2003
(dated 31-Mar-2004).
The company submitted its eighth annual revision to the site EMP, required under Schedule 5(i) of IPCL
Register Number 545, on 01-Apr-2004. A report on the implementation of the eight revision of the EMP
(covering the calendar year 2004) was submitted to the EPA as part of the company's AER for 2004.
The company submitted its Ninth annual revision to the site EMP, required under Schedule 5(i) of IPCL
Register Number 545, on 01-Apr-2005. A report on the implementation of the ninth revision of the EMP
(covering the calendar year 2005) was submitted to the EPA as part of the company's AER for 2005.
In the intervening period IPCL Register Number 545, which was issued on 31-Oct-2000, was superseded
by IPPCL Register Number P0006-03 on 02-Feb-2006.
The company submitted its Tenth annual revision to the site EMP, required under Condition 2.2.2.3 and
Schedule D of IPPCL Register Number P0006-03, on 01-Apr-2006. A report on the implementation of the
tenth revision of the EMP (covering the calendar year 2006) was submitted to the EPA as part of the
company's AER for 2006.
The company submitted its Eleventh annual revision to the site EMP, required under Condition 2.2.2.3
and Schedule D of IPPCL Register Number P0006-03, on 01-Apr-2007. A report on the implementation
of the eleventh revision of the EMP (covering the calendar year 2007) was submitted to the EPA as part
of the company's AER for 2008.
The company submitted its Twelfth annual revision to the site EMP, required under Condition 2.2.2.3 and
Schedule D of IPPCL Register Number P0006-03, on 01-Apr-2008. A report on the implementation of the
twelfth revision of the EMP (covering the calendar year 2008) was submitted to the EPA as part of the
company's AER for 2008.
The company submitted its Thirteenth annual revision to the site EMP, required under Condition 2.2.2.3
of the thirteenth revision of the EMP (covering the calendar year 2009) was submitted to the EPA as part
The company submitted its Fourteenth annual revision to the site EMP, required under Condition 2.2.2.3
of the fourteenth revision of the EMP (covering the calendar year 2010) was submitted to the EPA as part
The company submitted its Fifteenth annual revision to the site EMP, required under Condition 2.2.2.3
of the fifteenth revision of the EMP (covering the calendar year 2011) is currently being submitted to the
EPA as part of the company's AER for 2011.
5
The company submitted its Sixteenth annual revision to the site EMP, required under Condition 2.2.2.3
and Schedule D of IPPCL Register Number P0006-03, on 31-Oct-2012. A report on the implementation
of the sixteenth revision of the EMP (covering the calendar year 2012) was submitted to the EPA as part
The company submitted its Seventeenth annual revision to the site EMP, required under Condition
2.2.2.3 and Schedule D of IPPCL Register Number P0006-03, on 31-Aug-2013. A report on the
implementation of the seventeenth revision of the EMP (covering the calendar year 2013) is currently
being submitted to the EPA as part of the company's AER for 2013.
This document is the eighteenth annual revision to the site EMP required under Condition 2.2.2.3 and
Schedule D of IEL Register Number P0006-03. By default it is a more concise document than the original
and subsequent revisions. The structure of this eighteenth revision follows that of the seventeen
preceding documents. Consequently, cross-reference is made to the preceding documents where there
have been no significant changes. Subject to approval by the Agency, a report on the implementation of
this eighteenth revision of the EMP (covering the calendar year 2014) will be forwarded to the EPA as
part of the company's AER for 2014 (due 31-Mar-2015) in accordance with the provisions of Condition
2.2.2.3 and Schedule D of IEL Register Number P0006-03.
Section 3.0 of this document presents the company's Environmental Statement for the three years
covering 2010 to 2012. This document was produced to meet the requirements of the European
Communitys Eco-Management and Audit Scheme (EMAS) Regulation (Regulation 1221/2009). With the
publication of this independently verified document Novartis Ringaskiddy Limited completed eighteen
years of continuous participation in EMAS. Now into its eight cycle of EMAS participation the company
intends to publish an independently verified interim Environmental Statement (for the calendar year 2013)
during the second-half of 2014. Novartis Ringaskiddy Limited was the first Irish company in the
Chemical/Pharmaceutical sector to register under the scheme.
The objective of EMAS is to
"promote continual improvements in the environmental performance organisations by:
(a) the establishment and implementation of environmental policies, programmes and

management systems by organisations;
(b) the systematic, objective and periodic evaluation of the performance of such systems;
(c) the provision of information of environmental performance and an open dialogue with the
public and other interested parties;
(and)
6
(d) the active involvement of employees in the organisation and appropriate initial and
advanced training that makes participation in the tasks referred to under (a) possible."
Participation in EMAS is voluntary and the Irish Government actively supports such participation.
To assist in the provision of information concerning environmental performance to the public, EMAS
requires participating companies to prepare an Environmental Statement. The contents of this Statement
have to be validated by an independent and nationally accredited verifying organisation. In Novartis
Ringaskiddy Limited's case this is SGS United Kingdom Limited. Environmental Statements are normally
produced every three years. However, EMAS participation also requires companies to produce annual
interim Environmental Statements during years when a full Environmental Statement is not being
prepared. The contents of such interim statements also have to be independently verified. The document
reproduced in Section 3.0 is Novartis Ringaskiddy Limited's latest Environmental Statement covering the
calendar years 2010 to 2012.
The contents of the 2010 to 2012 Environmental Statement underline Novartis Ringaskiddy Limited's on-
going commitment to environmental protection. The document complements the company's first
Environmental Statement of 1996 (covering the years 1994 and 1995); second Environmental Statement
of 1998 (covering the years 1996 and 1997); third Environmental Statement of 2001 (covering the years
1998, 1999 and 2000); fourth Environmental Statement of 2004 (covering the years 2001, 2002 and
2003); fifth Environmental Statement of 2007 (covering the years 2004, 2005 and 2006); and sixth
Environmental Statement of 2010 (covering the years 2007, 2008 and 2009); meetings with the local
community and the records of the approximately 228,000 analyses that are carried out on an annual
basis to check the company's environmental performance and which are also available to the public.
It is noteworthy that despite this transparent and long-term commitment to improving environmental
performance that implementation of IEL Register Number P0006-03 necessitated an approximate 71%
increase in environmental analyses (from approximately 133,000 analyses per annum in 2005 to
approximately 228,000 analyses per annum in 2013); together with additional regulatory requirements.
As noted above the next interim Environmental Statement will be issued during the second-half of this
year and will outline the company's efforts in respect of environmental protection for the calendar year
2013.
Section 4.0 of this proposal outlines any changes to the Management of the Activity (more correctly
referred to as aspects of the Environmental Management System (EMS) at Novartis Ringaskiddy
Limited). Some of the changes/modifications outlined in this section will not be completed during the
lifetime of this proposed revision to the EMP. This is because of the detailed nature of the work involved.
However, subsequent revisions to this document will present an update on the proposals described in this
document.
Section 5.0 outlines the 2014 EMP and associated targets. This section is slightly modified in that it now
takes cognisance of the requirements of Condition 2.2.2.3 of IEL Register Number P0006-03.
7
3.0 ENVIRONMENTAL STATEMENT 2010 to 2012
One of the requirements of Novartis Ringaskiddy Limiteds participation in the EMAS scheme is that the
company makes key data in relation to its environmental performance freely available to the general
public. The primary vehicle for doing this is an Environmental Statement. The contents of this statement
are subject to independent verification on an audit cycle of not longer than three years. During intervening
years key environmental data is made available in a more concise annual report whose contents are also
independently audited.
The Environmental Statement and the Interim Environmental Statements provide information on:
The companys direct environmental aspects:
general progress in the area of environmental protection;
production volumes;
water and energy consumption;
emissions to water and air;
noise;
groundwater quality; and
waste.
The companys indirect environmental aspects:
participation in Novartis Corporate Citizenship programmes;
supporting Novartis in the Global Reporting Imitative;
supporting the Novartis global Community Partnership Day; and
enhancing local biodiversity; and provision of local amenity walkways.
These documents are available to the public.
8
To-date Novartis Ringaskiddy Limited has produced seven Environmental Statements as part of the
companys registration under the EMAS scheme. The most recent Environmental Statement issued by
the company covers the calendar years 2010 to 2012 is included as an inset on the page after next.
Taken on an annual basis the key environmental data in the companys Environmental Statements and
interim Environmental Statements should serve to demonstrate how consumption of resources and
emissions to the environment, expressed per tonne of product, are progressively decreasing at the
Ringaskiddy facility. The data set for the years up to 2012 confirms that this generally continues to be the
case at Novartis Ringaskiddy Limited. These data can be compared with data for the years from 1994
(when manufacturing commenced at the facility) to 2012 and which have been included in the companys
original EMP and subsequent revisions.
Novartis Ringaskiddy Limited considers that the information contained in the following pages compares
favourably with preceding reports.
9
Insert: EMAS Environmental Statement 2010 to 2012
10
ENVIRONMENTAL STATEMENT
2010 to 2012
(Prepared to Meet the Requirements of the European Communitys EMAS Regulation)
This site has an Environmental Management System and

its environmental performance is reported on to the public
in accordance with the Community Eco-Management
and Audit Scheme.
(Registration Number IE-002)

ENVIRONMENTAL STATEMENT 2010 to 2012
FOREWORD I have pleasure in presenting Novartis Ringaskiddy Limiteds Environmental Statement for
the years 2010 to 2012. It summarises the companys environmental performance during
these years; identifies the companys environmental targets for 2013; and describes the
means by which the facilitys impact on the environment is minimised. I think that we can
recognise some excellent progress in respect of environmental protection when one com-
pares this data set with that of the preceding three year period between 2007 and 2009.
Although the volume and types of drug substances shipped during these two three-
year periods was quite similar there were a number of changes made to the way we run
our business that have fed into an improved environmental performance. One of the
key drivers was the introduction of the E1W Process in the Diovan Process Unit during
2011, which has brought important production and material efficiencies.
This can be clearly seen in the relative decrease of approximately 17% in the con-
sumption of fresh solvent required between 2010 and 2012 when compared to 2007 to
2009. In total this represents a decrease of some 5,000 tonnes of fresh solvent required
to support the same level of production, which is excellent news.
In addition to improving existing processes the company has commenced the manu-
facture of four new drug substances for market between 2010 and 2012 as it rejuve-
nates its production portfolio. Further additions to the portfolio are currently underway
and although undoubtedly the introduction of these new processes will bring challenges
they also lay an important foundation for the future of the Ringaskiddy operation as the
output of some of the companys older products decreases.
External recognition for our efforts is always welcome and in this respect a highlight
of the past three years was the conferring on the company of a Novartis Corporate HSE
Energy Excellence Award in 2011 for a thought-leading refrigeration project; and a No-
vartis Corporate HSE Energy and Environment Excellence Award in 2012 for an energy
optimisation project. The latter project involved the installation of a wet electrostatic pre-
cipitator at the companys liquid vapour incinerator; and also a district heating system
based on the recovery of low grade heat from the liquid vapour incinerator.
These efforts are reflected in the data presented in this Environmental Statement where
it can be seen that the relative energy consumption was reduced by approximately 9%
when the years 2010 to 2012 are compared with the preceding three years. Of special
note is the energy consumption data for 2012 represented an historic low for the facil-
ity. I extend my thanks to the facilitys Energy Management Group and the local energy
committees that have helped to facilitate this great achievement.
We can also see that the improvements in materials management and energy man-
agement are having a positive impact on emissions to atmosphere from the facility. In
particular emissions of Carbon Dioxide underwent a relative decrease of some 7% when
the current three-year period is compared with the years 2007 to 2009. This of course
built on the relative reduction of 17% when the latter period is compared with the years
2004 to 2006.
Fugitive emissions of Organic Carbon also underwent a relative reduction of some 23%
when the years 2010 to 2012 are compared with the preceding three-year period. This
too built on the relative reduction of 61% that was recorded when the latter period is
compared with the years 2004 to 2006.
The company has implemented a number of significant waste management projects

over the past number of years and these, together with process improvements in produc-
II
tion, have fed through to a relative reduction of some 17% in the volumes of hazardous
waste generated between 2010 and 2012 when compared to the preceding three-year
period. In quantitative terms this represents approximately 5,000 tonnes of hazardous
waste, which mirrors the reduced requirement for fresh solvent in production over the
same time period.
I also note that the amount of non-hazardous waste generated at the facility was re-
duced in relative terms by 9% when the current three-year time period is compared with
the years 2007 to 2009. And of course it is good to note that the company is sending
some 90% of this material for reuse and recycling off-site. One of the really positive ini-
tiatives undertaken in recent years has been the progressive roll-out of collecting food
waste for composting, which is something that we as individuals can all contribute to.
Finally I know that all of us on the Campus are aware of the significant challenges
posed to the operation of the companys wastewater treatment plant during 2013. How-
ever, it would be remiss not to note the very significant improvements made over the
past decade. For example, the total volume of effluent discharged from the facility has
decreased by some 20% when the data in this Environmental Statement is compared
with that in the two previous Environmental Statements, which represents a decrease of
some 138,000 tonnes of effluent.
During the same period the key parameter of Chemical Oxygen Demand has been
reduced by some 10%, which represents a decrease of 9.6 tonnes. I am confident that
the recent upgrading works at the wastewater treatment plant together with changes in
which the plant is operated on a day-to-day basis will enable the company to consolidate
on the excellent progress made over the past number of years and will feed through to a
positive outcome when the next Environmental Statement is published in 2016.
I hope that you find this current Environmental Statement both informative and inter-
esting.
David Mitchell
Managing Director
III
TABLE OF CONTENTS
1 INTRODUCTION ECO-MANAGEMENT AND AUDIT SCHEME 1
2 NOVARTIS RINGASKIDDY LIMITED PRODUCT PORTFOLIO 2010 to 2012 2
3 NOVARTIS RINGASKIDDY LIMITED SITE HSE POLICY 7
4 ENVIRONMENTAL IMPACTS AND CONTINUOUS IMPROVEMENT IN THE AREA

OF ENVIRONMENTAL PROTECTION 8
4.1 TOTAL PRODUCTION 8
4.2 WATER AND ENERGY CONSUMPTION 12
4.3 DISCHARGES TO WATER/GROUNDWATER AND SURFACE WATER PROTECTION 15
4.4 EMISSIONS TO AIR/AMBIENT AIR QUALITY/NOISE 17
4.5 NON-HAZARDOUS WASTE 19
4.6 HAZARDOUS WASTE 20
4.7 LOCAL BIODIVERSITY 21
2010 BIODIVERSITY UPDATE 22
5 SOCIAL PERFORMANCE and CORPORATE RESPONSIBILITY 26
5.1 CORPORATE RESPONSIBILITY POLICY 27
5.2 COMMUNITY PARTNERSHIP DAY 30
6 ENVIRONMENTAL MANAGEMENT SYSTEM 35
6.1 ENVIRONMENTAL MANAGEMENT 35
6.2 IPPC LICENCE 36
6.3 ENVIRONMENTAL MANAGEMENT PROGRAMME 36
6.4 ENVIRONMENTAL AUDITING 37
6.5 ENVIRONMENTAL REGISTERS 38
6.6 CORPORATE COMMITMENT 38
6.7 INVESTMENTS AND EXPENDITURES IN SAFETY AND ENVIRONMENTAL PROTECTION 38
6.8 SITE ENVIRONMENTAL COMMITTEE/TECHNICAL COORDINATION COMMITTEE/ENERGY

MANAGEMENT GROUP 39
IV
TABLE OF CONTENTS (continued) V
6.9 ENVIRONMENTAL COMMUNICATION 39
6.10 EMERGENCY MANAGEMENT 40
7 ENVIRONMENTAL OBJECTIVES 42
7.1 INTRODUCTION 42
7.2 IPPC LICENCE COMPLIANCE 42
7.3 RESOURCE CONSERVATION 42
7.4 ENVIRONMENTAL TARGETS 2013 43
7.5 UPDATE ON ENVIRONMENTAL TARGETS 2010 to 2012 45
8 VERIFIERS DECLARATION 46
9 FURTHER INFORMATION 46
APPENDIX 1 ENERGY SAVING INITIATIVES 2010 to 2012 47
APPENDIX 2 ENVIRONMENTAL TARGETS 2010 to 2012 49
A.2.1 YEAR END UPDATE ON ENVIRONMENTAL TARGETS 2010 49
APPENDIX 3 COMMITMENT TO BAT 62
APPENDIX 4 ENVIRONMENTAL IMPACT DATA 2010 to 2012 65
A.4.1 TOTAL PRODUCTION 65
A.4.2 - WATER CONSUMPTION 65
A.4.3 ENERGY CONSUMPTION 65
A.4.4 DISCHARGES TO WATER 66
A.4.5 EMISSIONS TO AIR 68
A.4.6 HAZARDOUS WASTE 70
A.4.7 NON-HAZARDOUS WASTE 72
A.4.8 NOISE 73
A.4.9 AMBIENT AIR QUALITY 73
A.4.10 GROUNDWATER AND SURFACE WATER QUALITY 73
V
TABLE OF CONTENTS (continued) VI
APPENDIX 5 RESOURCE CONSERVATION 2007 to 2012 74
A.5.1 NATURAL GAS CONSUMPTION 75
A.5.2 ELECTRICITY CONSUMPTION 75
A.5.3 WATER CONSUMPTION 75
A.5.4 FUGITIVE EMISSIONS 75
A.5.5 TOTAL HAZARDOUS WASTE GENERATED 75
A.5.6 NON-HAZARDOUS WASTE TO BE TREATED/DISPOSED 76
A.5.7 SOLVENT TO BE RECTIFIED 76
APPENDIX 6 ASSESSMENT OF SIGNIFICANCE OF ENVIRONMENTAL ASPECTS 77
APPENDIX 7 EMAS CORE INDICATORS 2010 to 2012 79
A.7.1 EMAS CORE INDICATORS 2010 75
VI
1 INTRODUCTION
This Environmental Statement has been prepared in accordance with the provisions ECO-MANAGEMENT
of the European Communitys Eco-Management and Audit Scheme - more commonly AND AUDIT SCHEME
known as EMAS.
The objective of EMAS is to promote continual improvements in the environmental

performance of organisations by:
(a) the establishment and implementation of environmental management systems by

organisations;
(b) the systematic, objective and periodic evaluation of the performance of such sys-
tems;
(c) the provision of information on environmental performance and an open dialogue

with the public and other interested parties; and
(d) the active involvement of employees in the organisation and appropriate initial and
advanced training that makes active participation in the tasks referred to under (a)
possible.
Participation in EMAS is voluntary and the Irish Government actively supports such
participation.
To assist in the provision of information concerning environmental performance to

the public, EMAS requires participating companies to prepare an Environmental State-
ment on a cycle of not more than three years and Interim Environmental Statements
during the intervening years. The purpose of the Interim Environmental Statement is to
provide for an annual update to the information contained in the most recent Environ-
mental Statement. The contents of both types of Statement have to be validated by an
independent and nationally accredited verifying organisation. In Novartis Ringaskiddy
Limiteds case this is SGS United Kingdom Limited.
This is the seventh Environmental Statement that Novartis Ringaskiddy Limited has
published and covers the years 2010 to 2012. It refers to the data already published in
the companys 2010 and 2011 Interim Environmental Statements; in addition to com-
plementing the information presented in the companys previous Environmental State-
ments, which cover the years from 1995 to 2009.
The document updates the companys product portfolio and highlights progress in the
area of environmental protection. The companys Health, Safety and Environment (HSE)
Policy is also included. Detailed environmental performance data is included as an ap-
pendix to this document. This data provides for a year-by-year comparison of key data
over a six-year period.
The next externally verified Environmental Statement (covering the calendar years
2013 to 2015) will be issued in June of 2016. The next externally verified Interim Envi-
ronmental Statement (covering the calendar year 2013) will be issued in June of 2014.

2 NOVARTIS RINGASKIDDY LIMITED
PRODUCT PORTFOLIO Novartis Ringaskiddy Limited is designed to produce the drug substances for what are
2010 to 2012 often life-saving treatments for people around the world. The company does this while
being keenly aware of societys other demands for cost-effectiveness and environmental
excellence.
The drug substances produced at the facility are shipped ultimately to Novartis for-
mulation plants around the world, where these substances, which are responsible for
the therapeutic effect in a medicine, are formulated into tablets, capsules, ointment and
other dosage forms. To manufacture the medically active component of such medica-
tions it is necessary to go through many production cycles to ensure the purity and
potency of the active substance.
Novartis Ringaskiddy Limited manufactures a variety of pharmaceutical compounds

by standard chemical synthesis routes. Such synthesis and the related separation and
purification steps are carried out in standard chemical process equipment. The compa-
ny also manufactures active substances through application of purification procedures
(rather than chemical synthesis). Fermentation processes in existing facilities outside
Ireland produce the raw materials for the active substances falling into this category.
Crude materials, which are isolated from the fermentation slurry, are sent to the facility
at Ringaskiddy for final purification.
Novartis Ringaskiddy Limited exported 398 tonnes of pharmaceutical drug substances

in 2010; 270 tonnes in 2011 and 442 tonnes in 2012. The corresponding data for the
previous three years was as follows: 426 tonnes shipped in 2007; 317 tonnes shipped
in 2008; and 375 tonnes shipped in 2009. This represents a comparable production
output when the two sequential three-year periods are compared.
The 2010 to 2012 portfolio consisted of the following sixteen products, five of which
are among Novartis Pharmas top ten products based on global sales during 2012. Fur-
ther information on Novartis products is available from the companys website, which is
located at
http://www.novartis.com
Asmex 03 is an immediate precursor for the product Elidel (Pimecrolimus), a non-

steroid cream developed for treating atopic eczema. It is one of the first new eczema
treatments to have been introduced since the 1950s, when topical corticosteroids the
mainstay of therapy until now became available. Atopic eczema is a common skin
condition in which the patients skin is typically dry and from time-to-time becomes
inflamed, itchy and may crack, become infected, weep and form crusts. Elidel cream
1% is indicated as second-line therapy for the short-term and non-continuous chronic
treatment of mild to moderate atopic dermatitis in non-immunocompromised adults
and children 2 years of age and older, who have failed to respond adequately to other
topical prescription treatments, or when those treatments are not advisable. A total of
4,762 kgs of Asmex 03 was manufactured at Novartis Ringaskiddy Limited between
2010 and 2012.
Calcitonin, sold as Miacalcic, is a peptide that regulates calcium metabolism and is

mainly used in the treatment of osteoporosis. Osteoporosis is a disease that develops
with age and is characterised by a progressive and symptomless loss of bone mass,
leading to fragility of bones and an increased risk of fracture, notably in the spine, hip
and forearm. Calcitonin is a thyroid hormone that regulates the calcium content of the
blood. Available as a daily nasal spray, which is particularly easy and safe to use, Mia-
calcic prevents further loss of bone mass and promotes healthy normal bone forma-

tion. Miacalcic is effective, safe and well tolerated. As a peptide Calcitonin is one of PRODUCT PORTFOLIO
the companys low volume, high value products and a total of 6 kgs of Calcitonin was 2010 to 2012
manufactured at Novartis Ringaskiddy Limited between 2010 and 2012. (Continued)
Clozapine is one of the companys older products and was not manufactured at No-
vartis Ringaskiddy Limited in many years. During 2010 and 2012 the company was
requested to product and ship 5,281 kgs of Clozapine to make up a shortfall in output
from other manufacturing sites. The product is an antipsychotic agent that has the ben-
efit of the virtual absence of the severe side effects that are usually observed with other
antipsychotic agents when used for long-term treatment. The product is sold as Lep-
onex/Clozaril in its final formulation.
Cyclosporine is the active ingredient of Neoral (capsules and oral solution) an im-
munosuppressant used to prevent organ rejection following a kidney, liver or heart trans-
plant. Neoral is one of the worlds most commonly used primary immunosuppressants,
largely replacing its predecessor Sandimmun, which revolutionized organ transplanta-
tion when it was introduced by Novartis in 1982. First launched in 1995, Neoral is also
used in treating select autoimmune disorders such as psoriasis and rheumatoid arthritis.
Sandimmun/Neoral is one of Novartis Pharmas top twenty global products (based
on 2012 sales). Cyclosporine accounted for approximately 8% of all drug substances
shipped from Novartis Ringaskiddy Limited between 2010 and 2012 representing
some 87,507 kgs.
Darifenacin is the active drug substance in Emselex (also known as Enablex in the
United States (US)) a once-daily oral treatment for overactive bladder. This product was
approved in the European Union (EU) and the US in 2004 and has been shown to reduce
the number of weekly urge urinary incontinence episodes by up to 83% versus pla-
cebo. A total of 5,786 kgs of Darifenacin was shipped from Novartis Ringaskiddy Limited
between 2010 and 2012.

PRODUCT PORTFOLIO Diovan (Valsartan) and Co-Diovan/Diovan HCT (Valsartan and Hydrochlorothiazide)
2010 to 2012 are leaders in the angiotensin-II receptor blocker (ARB) class of high-blood pressure
(Continued) agents and together comprise the worlds best-selling brand of high blood pressure
medicines. Diovan is the only agent in its class approved to treat all of the following:
Patients with high blood pressure, high-risk heart attack survivors and patients with heart
failure. The efficacy and safety profile of Diovan has been well-established by a large body
of evidence. Diovan inhibits a hormone, angiotensin II, from binding to a receptor that
causes arteries to tighten and narrow, an action that can cause high blood pressure. The
single-pill combination product Co-Diovan includes the diuretic hydrochlorothiazide and
provides additional efficacy for patients needing a greater reduction in blood pressure. In
July 2011, the US Food and Drug Administration (FDA) approved Diovan HCT as a first-line
therapy. First launched in 1996, Diovan is available in more than 100 countries.
Diovan is currently one of Novartis Pharmas flagship products accounting for ap-
proximately 20% of Novartis Pharmas worldwide sales in 2012. It also accounted for
approximately 67% of all drug substances shipped from Novartis Ringaskiddy Limited
between 2010 and 2012 representing some 741,197 kgs and is one of the compa-
nys great achievements of recent years.
Fluvastatin, sold as Lescol and as Lescol XL in an extended release formulation, is

a drug that is used in the treatment of high cholesterol levels. The drug affects a broad
range of lipid parameters, including high-density lipoprotein (HDL) cholesterol. In 70
percent of all patients with coronary heart disease, HDL cholesterol levels are too low.
Lescol XL raises HDL cholesterol (the good cholesterol) by up to 20 percent and has
also been shown in trials to provide effective and comprehensive lipid management. It
reduces low-density lipoprotein (LDL) (bad) cholesterol levels by up to 38 percent and
lowers triglycerides (TG) by up to 25 percent. Fluvastatin accounted for approximately
8% of all drug substances shipped from Novartis Ringaskiddy Limited between 2010
and 2012 representing some 86,955 kgs.
Glivec (also known as Gleevec in the United States) (Imatinib Mesylate/Imatinib)

is a signal transduction inhibitor approved to treat certain forms of chronic myeloid
leukemia (CML) and gastrointestinal stromal tumours (GIST). First launched in 2001,
Glivec is available in more than 80 countries. It is one of the first oncology drugs
that validates rational drug design based on an understanding of how some cancer
cells work. It is a signal transduction inhibitor and it interferes with the pathways that
stimulate the growth of tumour cells. In the US, Gleevec/Glivec is used to treat newly
diagnosed adult and paediatric patients with a form of CML: this condition is a rare form
of cancer but one of the most common adult leukemias, and it usually tests positive for
the presence of the Philadelphia (Ph) chromosome.
Gleevec/Glivec is also indicated for the treatment of patients with certain forms of
GIST and, in the US, Gleevec/Glivec is also approved for aggressive systemic mas-
tocytosis. In 2008 Gleevec/Glivec received US regulatory approval for an adjuvant
treatment of patients with GIST and is awaiting approval in Europe. Gleevec/Glivec
is also approved in the US and Europe for the treatment of Philadelphia-positive acute
lymphoblastic leukemia (ALL) and in certain markets for use in various rare cancers.
Novartis Ringaskiddy Limited takes particular pride in its role in making this treat-
ment available to patients as it was the manufacturing launch site for the active drug
substance. A total of 107,504 kgs of Glivec were manufactured at Novartis Ringaskiddy
Limited between 2010 and 2012 representing approximately 10% of the facilitys prod-
uct output. Glivec was the highest ranked of Novartis Pharmas top ten products based
on 2012 global sales.

Glycopyrronium Bromide is the active ingredient of Seebri Breezhaler, a long-acting PRODUCT PORTFOLIO
muscarinic antagonist (LAMA) and received its first regulatory approvals in September 2010 to 2012
2012. Seebri Breezhaler 44 mcg delivered dose (equivalent to 50 mcg measured dose (Continued)
per capsule) received approval in the EU as a once-daily inhaled maintenance bron-
chodilator treatment to relieve symptoms for adult patients with chronic obstructive
pulmonary disease (COPD) (chronic bronchitis and emphysema). The Jananese regula-
tory authorities approved once-daily Seebri Inhalation Capsules 50 mcg administered
through the Breezhaler device as an inhaled maintenance bronchodilator treatment for
the relief of various symptoms due to airway obstructive disease in COPD. A Phase III
clinical trial program for Glycopyrronium Bromide has been agreed with the FDA. Filing
in the US is expected in 2014. Seebri is the second inhaled COPD product delivered to
patients via the low resistance Breezhaler device. A total of 50 kgs of Glycopyrronium
Bromide was shipped from Novartis Ringaskiddy Limited in 2012.
Indacaterol Maleate is the active ingredient of Arcapta Neohaler/Onbrez Breezhaler

and is a long-acting beta2-agonist administered in a single-dose dry powder inhaler
indicated for long-term, once-daily maintenance bronchodilator treatment of airflow ob-
struction in patients with COPD. Once-daily Onbrez Breezhaler was first approved in the
EU in November 2009 and is now approved in more than 90 countries. In July 2011,
the FDA approved a 75 mcg once-daily dose of indacaterol under its US trade name,
Arcapta Neohaler, and Japanese regulatory authorities approved Onbrez Inhalation Cap-
sules in a 150 mcg once-daily dose. In 2012, Onbrez Breezhaler 150 mcg was also ap-
proved in China. It was the first inhaled COPD product administered to patients via the
low resistance Breezhaler device. Indacaterol Maleate is now approved in approximately
100 countries. A total of 124 kgs of Indacaterol Maleate was shipped from Novartis Rin-
gaskiddy Limited in 2012.
Ketotifen Hydrogen Fumarate is the active ingredient of Zaditen, an oral asthma pro-
phylactic and anti-allergic that is used in the treatment and prevention of paediatric
asthma, allergic skin diseases (atopic dermatitis and urtiaria) and allergic rhinitis (hay
fever). It is a non-bronchodialator anti-asthmatic drug with marked anti-anaphylactic
properties and a specific antihistaminic effect. A total of 585 kgs Ketotifen Hydrogen
Fumarate was shipped from Novartis Ringaskiddy Limited between 2010 and 2012.
Octreotide Acetate is the active ingredient of Sandostatin LAR/Sandostatin SC,

which is used for the treatment of patients with acromegaly, a chronic disease in adults
caused by over-secretion of pituitary growth hormone. It is also approved for use to treat
certain symptoms associated with carcinoid tumours and other types of gastrointestinal
neuroendocrine and pancreatic tumours. Sandostatin is a synthetic protein that mim-
ics the action of somatostatin, a naturally occurring hormone.
New technology has enabled patients to be treated once a month with injections of
Sandostatin LAR Depot (long-acting release), allowing them greater freedom. Two vari-
ants of Octreotide Acetate can be produced at Novartis Ringaskiddy Limited, one of
which uses state-of-the-art technology to assemble the Octreotide Acetate molecule. As
a peptide Octreotide Acetate is one of the companys low volume, high value products
and a total of 160 kgs of Octreotide Acetate was manufactured at Novartis Ringaskiddy
Limited between 2010 and 2012. Sandostatin LAR/Sandostatin SC is one of Novartis
Pharmas top ten products (based on worldwide sales in 2012).
Pasireotide Diaspartate is the active ingredient of Signifor and is a multireceptor tar-

geting somatostatin analog. Signifor was approved in the EU in April 2012 and in the
US in December 2012 for the treatment of adult patients with Cushings disease, an
endocrine disorder caused by excessive cortisol, for whom surgery is not an option or

PRODUCT PORTFOLIO has failed. Signifor is the first approved pituitary-targeted medicine for Cushings dis-
2010 to 2012 ease. A Phase III study of Signifor long acting release (LAR) in inadequately controlled
(Continued) acromegaly recently met the primary endpoint. Novartis Ringaskiddy Limited shipped a
total of 3 kgs of Pasireotide Diaspartate during 2012.
Ruxolitinib Phosphate is the active ingredient of Jakavi and is an oral inhibitor of the
JAK 1 and JAK 2 tyrosine kinases indicated for the treatment of disease-related splenom-
egaly or symptoms in adult patients with primary myelofibrosis, post-polycythemia vera
myelofibrosis or post-essential thrombocythemia myelfibrosis. Jakavi is currently ap-
proved in more than 45 countries, with additional regulatory filings underway. Data pre-
sented at the European Hematology Association Annual Meeting showed that Jakavi im-
proves overall survival and sustained reductions in spleen size compared to conventional
therapy. In this three-year follow-up analysis of the Phase III COMFORT-II study, a 52%
reduction in risk of death was observed in the Jakavi arm compared with conventional
therapy. Novartis Ringaskiddy Limited shipped a total of 115 kgs of Ruxolitinib Phos-
phate during 2012.
Tasigna (Nilotinib) is a signal transduction inhibitor of the tyrosine kinase activity of Bcr-
Abl, KIT and the PDGF-receptor. Since its launch in 2007, Tasigna has been approved in
more than 95 countries to treat patients with Ph+ CML in the chronic and/or accelerated
phase who are resistant or intolerant to existing treatment, such as Gleevec/Glivec. It is
also approved in more than 70 markets, including the US, EU, Switzerland and Japan, to
treat newly diagnosed patients in the chronic phase. Results from the global, randomized
Phase III trial called ENESTnd (Evaluating Nilotinib Efficacy and Safety in Clinical Trials of
Newly Diagnosed Ph+ CML Patients), a head-to-head comparison against Gleevec/Glivec,
showed that Tasigna produced faster and deeper responses than Gleevec/Glivec in adult
patients with newly diagnosed Ph+ CML. In the ENESTnd four-year follow-up, the difference
in the rates of deep molecular response continued to be significantly higher for Tasigna than
for Gleevec/Glivec, with the difference in favour of Tasigna increasing over time. In ad-
dition, a sub-analysis showed that more than three times as many patients achieved early
molecular response (reduction in Bcr-Abl transcript levels to 10% at months three
and six) with Tasigna as first-line therapy instead of Gleevec/Glivec. In addition to the
on-going studies in Ph+ CML, trials are also underway examining the use of Tasigna in
patients with c-Kit mutated, advanced melanoma. Novartis Ringaskiddy Limited shipped
a total of 1,276 kgs of Tasigna in 2012.
Terbinafine is the active ingredient in Lamisil. In fungal nail infections (onychomy-

cosis), nails can become discoloured or thickened and even splinter as dermatophyte
fungi attack the nail plate, nail bed or nail matrix. Such fungal nail infections are highly
prevalent throughout the world, and an estimated 20% of the population aged between
40 and 60 suffers from this condition. Popular public areas such as swimming pools,
fitness rooms and even hotel carpets offer ideal conditions for the continuing spread of
fungal infections. Treatment with Lamisil tablets is innovative in that it actually eradi-
cates the fungus causing the infection from the inside. Other antifungals merely prevent
the fungus from reproducing. Lamisil is well-tolerated and has a well-established safety
profile and over 22 million patients have been treated with Lamisil tablets, which are
available in more than 50 countries. Terbinafine accounted for approximately 6% of all
drug substances shipped from Novartis Ringaskiddy Limited between 2010 and 2012
representing a total volume of 66,478 kgs.

3 NOVARTIS RINGASKIDDY LIMITED SITE HSE POLICY
Novartis Ringaskiddy Limited Health, Safety and Environment Policy
As a member of the Novartis Group of companies Novartis Ringaskiddy Limited wants to be known for being a responsible
corporate citizen. This means that we do everything that we can to operate in a manner that is sustainable: Economically,
socially and environmentally in the best interest of long-term success for our enterprise. We expect all our employees to
implement this policy and the Group policy on Corporate Citizenship.
We integrate Health, Safety and Environmental Protection into our business strategies to add value to the enterprise, to
manage risk and to enhance the reputation of the company.
The health and safety of our employees, neighbours, customers and consumers, and the protection of the environ-
ment are company priorities consistently pursued at all levels in the organisation.
We take HSE into account in all business decisions and activities. All departments establish proper structures and al-
locate sufficient resources in order to live up to this policy.
Each employee shall comply with the HSE guidelines and the laws applicable to their area of operational responsibility.
We want to be a leader in Health, Safety and Environmental Protection by managing these disciplines actively, consistently
and efficiently.
We strive for continual improvement in our HSE performance. We measure progress and verify compliance with No-
vartis Corporate HSE guidelines and National regulatory requirements through audits and management reviews. To
this end we set clear annual objectives and targets, which are assessed on an on-going basis.
We foster awareness and a sense of responsibility for HSE among our employees; to this end we provide appropriate
information and training and develop their HSE skills.
We optimise the use of natural resources and minimise the environmental impact of our activities so as to conduct
our business in as sustainable a manner as is possible.

We assess HSE implications to ensure that the benefits of manufacturing new products and introducing new technolo-
gies and processes outweigh remaining risks.
We care about the expectations and concerns of our stakeholders.
We provide our employees with safe workplaces. We promote programmes to maintain or improve the health of our
employees.
We cooperate with our suppliers and contractors and offer assistance to enable them to achieve an HSE performance
matching our own.
We recognise the interest of our employees, neighbours, customers, the authorities and the public at large in our
societal behaviour; and the HSE impacts of our business. We provide relevant information and actively listen to stake-
holders. We openly communicate and provide the information necessary to understand the risks and effects of our
operations on health, safety and the environment.
David Mitchell, 12-Jul-2012

Managing Director, Novartis Ringaskiddy Limited

OF ENVIRONMENTAL PROTECTION
4.1 Production volumes at Novartis Ringaskiddy Limited were approximately the same over
TOTAL PRODUCTION the years 2010 to 2012, when compared to the previous three years. Approximately
1,110 tonnes of drug substances were shipped between 2010 and 2012 compared to
approximately 1,118 tonnes of drug substances shipped between 2007 and 2009. It is
anticipated that production volumes will remain at a similar level over the coming three
years.
The largest volume product during the years 2010 to 2012 was Diovan, which ac-
counted for 67% of the 1,110 tonnes of drug substances shipped during this period.
Special focus was given to optimising the Diovan process during 2010 and 2011 in an
effort to optimise energy inputs, material use, product yield and hazardous waste man-
agement associated with the product.
A total of five of the sixteen drug substances shipped during the years 2010 to 2012
accounted for over 98% of the facilitys output. In addition to Diovan, Glivec, Cy-
closporine, Fluvastatin and Terbinafine were also relatively high volume products and
accounted for 10%, 8%, 8% and 6% respectively of shipped material during the years
2010 to 2012. The product portfolio remained largely the same over the years 2010 to
2012 when compared to the years 2007 to 2009, however, there were some notable new
additions to the companys product portfolio towards the end the three-year period of
2010 to 2012.
Recently launched products accounted for USD 16.3 billion or 29% of Novartis Group
net sales in 2012 - up from 25% in 2011. Continuing to rejuvenate its portfolio, the
Pharmaceuticals Division achieved 11 major regulatory approvals for innovative medi-
cines and new indications in the US and the EU. Included in these key approvals were
Ruxolitinib Phosphate in the EU for the treatment of myelofibrosis, and Glycopyrronium
Bromide in the EU for patients with COPD both of which were manufactured at Novartis
Ringaskiddy Limited during 2012.
Two other notable additions to Novartis Ringaskiddy Limiteds product portfolio in-
clude Indacaterol Maleate, which is used as a once-daily maintenance bronchodilator
treatment of airflow obstruction in patients with COPD; and Pasireotide Diaspartate,
which is used for the treatment of adult patients with Cushings disease, an endocrine
disorder caused by excessive cortisol, for whom surgery is not an option or has failed.
The Environmental Statement for 2007 to 2009 highlighted the potential of both Pa-
sireotide Diaspartate and Indacaterol Maleate and their progress to market in the inter-
vening period is indicative of the probable direction of manufacturing at the facility in
the coming years. To support the introduction of such products a dedicated Small Scale
Facility (SSF) has been developed at Novartis Ringaskiddy Limited. The SSF plant is lo-
cated north of Production Building 1A. The SSF commenced manufacture of these types
of low volume high value products during 2009 and is now fully operational.
The main inputs to production processes at the facility in respect of raw materials
are the solvents that are used in chemical reactions and purification processes. These
solvents do not form part of the final product and need subsequent recycling for reuse
The company has or suitable waste management, for example, incineration with heat recovery. The volume
commenced the of fresh solvent used is typically large with 7,453 tonnes of fresh solvent purchased in
manufacture of four 2010; 7,658 tonnes purchased in 2011; and 9,846 tonnes purchased in 2012.
new drug substances
between 2010 and 2012
as it rejuvenates
its production portfolio

There was a significant reduction in the requirement for purchase of fresh solvent over 4.1
the years 2010 to 2012 when compared to the preceding period of 2007 to 2009: A TOTAL PRODUCTION
decrease from 30,235 tonnes to 24,957 tonnes. This was significant as it was effected (Continued)
against a similar product portfolio and a similar product output. The key driver for this
change was a significant modification to the Diovan process during 2010 and 2011.
When normalised to production output the relative consumption of fresh solvent de-
creased from 27.0 kg of solvent per kg of product shipped between 2007 and 2009
to 22.5 kg of solvent per kg of product shipped between 2010 and 2012 or a relative
decrease of some 17%. The company primarily uses non-chlorinated solvents of which
Cyclohexane and Ethyl Acetate are used in the largest volumes (both accounted for ap-
proximately 30% of fresh solvent inputs during the period between 2010 and 2012).
Other solvents used in relatively large volumes include Methanol, Tetrahydrofuran, Ac-
etone and Isopropyl Acetate.
There was a relative

decrease of approximately
17% in the consumption
of fresh solvent material
between 2007 and 2009;
and 2010 and 2012 down
from a figure of 27.0 kg
of solvent per kg of product
shipped between 2007
and 2009 to 22.5 kg/kg
of product shipped between
2010 and 2012

4.1 New Production Process for Diovan is Successfully Introduced

TOTAL PRODUCTION
(Continued) Reducing the number of steps on a chemical synthesis pathway or telescoping
is an established method of reducing material inputs and energy consumption.
This is normally made possible when a new chemical synthesis route is developed
in the laboratory and transferred to the production plant. Savings are typically
made through less use of production equipment, utilities and raw materials. The
E1W (short for Eliminate 1 Work-up) process in Diovan also achieved this goal of
telescoping two process steps into one but without a fundamental change in the
chemistry of the manufacturing process. The elimination of one process step was
achieved by introducing controlled Near Infra-Red (NIR) technology, which allowed
the determination of a seeding point in the process. This was not possible on the old
production process. The change enabled a reduction in the number of crystallisa-
tion steps from two to one. NIR technology is also finding wide application in proc-
ess optimisation in other production processes at Novartis Ringaskiddy Limited.
Novartis Ringaskiddy Limited introduced the E1W process to the Diovan manufac-
turing plant during 2011. This work was undertaken in collaboration with Novartis
Pharmas Technical Research and Development Group and with the additional input
of the Diovan Process Units in Basel, Switzerland and Grimsby in the United King-
dom and has demonstrated significant material and energy savings. These savings
have effected primarily through process modification and optimisation; and there
is further scope for saving as the new process is established by increasing yield. A
full years savings could not be realised during 2011 as the new process was only
successfully established at the end of the first-quarter, however, a clearer view of the
new process impact can be seen in the data set for 2012.
The manufacturing process used to make Diovan at Novartis Ringaskiddy Limited,

up to the end of 2010, required two crystallisations, two filtrations and two drying
steps. Novartis Pharmas Technical Research and Development Group recognised,
in collaboration with the actual manufacturing sites, that is should be possible to
telescope two process steps into one but without a fundamental change in the
chemistry of the manufacturing process. The Technical Research and Development
Group proposed that the elimination of one process step on the old production
process could be achieved by introducing controlled NIR technology to allow the
determination of a seeding point in the process.
The new E1W Process was

introduced in the Diovan
Process Unit during 2011
bringing important
production and material
efficiencies
10
There are a number of key resource conservation implications for Novartis Rin- 4.1
gaskiddy Limited that have arisen from the implementation of this project. TOTAL PRODUCTION
(Continued)
The first is that for each batch of Diovan that is now manufactured on-site the use
of one crystalliser is no longer required; and that the use of one Nutsche (which is
used for filtration and drying after that crystalliser) is no longer required. To facilitate
product demand a total of three manufacturing lines were run in parallel on the old
procedure so in total the use of three crystallisers and three Nutsches is no longer
required. These production modules have now been freed up for other applications.
Consequently significant savings in the use of electricity have been achieved; and
additional savings in the use of heat that is generated by the use of natural gas have
also been secured.
The second is that significant savings have also been effected in the use of solvent
material in the new E1W process with a reduction in the requirement for the use of
fresh Ethyl Acetate by 15%; the use of recovered Ethyl Acetate by 25%; the use of
fresh Cyclohexane by 50%; and the use of recovered Cyclohexane by 30%. There-
fore additional energy savings have been made in the reduced requirement for the
operation of solvent recovery equipment. The on-site solvent recovery process is
powered by natural gas generated steam; so in addition to the energy savings for
this part of the project there are significant Scope 1 reductions of Carbon Dioxide.
There was a significant

reduction in
the requirement for both
fresh and recovered
Cyclohexane (solvent) with
the start-up of the E1W
process in Diovan
11
4.2 As noted in the 2007 to 2009 Environmental Statement significant progress was made in
WATER AND ENERGY the area of water and energy conservation over the years 2007 to 2009. Water consump-
CONSUMPTION tion was reduced from 0.91 m3/kg of drug substance shipped in 2003 to 0.73 m3/kg
of drug substance shipped by the end of 2006. A similarly positive trend was recorded
for total energy consumption during the same period: It decreased from 1.43 GigaJoule
(GJ)/kg of drug substance shipped to 1.33 GJ/kg of drug substance shipped.
There was a further decrease in the relative consumption of both resources during the
period between 2010 and 2012 so that at the end of 2012 water consumption was 0.59
m3/kg of drug substance shipped and energy consumption was 1.00 GJ/kg of drug sub-
stance shipped. This was effected through the completion of a number of very successful
energy saving and water conservation projects (see below). The company is confident
that the positive trend established over the past number of years (refer to the graphs in
Appendix 4 and Appendix 5 of this Environmental Statement) can be maintained and to
this end has again included very specific energy targets as part of the overall site envi-
ronmental targets for 2013.
Water consumption decreased from 0.79 m3/kg of drug substance shipped to 0.71
m3/kg of drug substance shipped when the consecutive three-year periods of 2007 to
2009; and 2010 to 2012 are compared. Energy consumption decreased from 1.36 GJ/
kg of drug substance shipped to 1.25 GJ/kg of drug substance shipped when the same
three-year periods are compared. The significance of this is that the production portfolio
and product output were broadly comparable during both three-year periods, which
indicates that real efficiencies have been secured.
During the years 2010 to 2012 the company continued to optimise its use of the
facilitys Energy Monitoring System; consolidated its participation in the Sustainable
Energy Authority of Irelands (SEAI) Annual Self Audit and Statement of Energy Accounts
Scheme; and fostered employee awareness, for example by participating in the Electric-
ity Supply Boards (ESB) Winter Demand Reduction Incentive; Energy Awareness Weeks;
and by conducting its own very successful Energy Awareness Campaign. The latter, which
was coordinated by the sites Energy Management Group, involved the distribution of
promotional and educational material to foster greater awareness of energy reduction
both in the workplace and at home.
A summary of the energy saving initiatives undertaken during the years 2010 to 2012
is included in Appendix 1. Implementation of these measures was overseen by the sites
Energy Management Group, which is chaired by the Technical Services Support Unit but
which has representatives from all of the main energy consuming areas on site.
A number of energy saving initiatives are now planned for 2013 following the Energy
and Water Assessment that was undertaken at Novartis Ringaskiddy Limited in Novem-
ber 2012 by energy experts from Novartis Pharma AG and energy consultants from BMG
Engineering Limited. The assessment identified some potential energy savings in the
sites Solvent Recovery facility that will be evaluated during 2013.
Water consumption was

These include investigation of heat integration particularly for the 108/109 continu-
reduced by approximately
ous process recovery columns. It may be possible to use condensation heat at high
10% - from 0.79 m3/kg
temperature for the first column; and then use an evaporate sump at a lower tempera-
of product shipped
ture for the second column, which could potentially result in lower steam consumption
of the order of 800 kg/hour. The same assessment also identified that the filters used
to 0.71 m3/kg of product
for the sites compressed air system were of a higher specification than was required and
that replacement with a suitably specified filter would result in energy savings based on
and 2012
a lower differential pressure.
12
2010 Special Corporate Recognition for Proposed Wind Turbine Project 4.2
WATER AND ENERGY
In 2010 Novartis Ringaskiddy Limited was actively looking at the option of install- CONSUMPTION
ing two wind turbines at the facility. There are a number of benefits that would flow (Continued)
from this project and the two key ones are that approximately 30% of the com-
panys electricity consumption could be generated on-site; and that additional
green or renewable electricity would be freed up for use elsewhere on the National
grid. The company saw this as a further means of consolidating on its current use
of electricity that is renewably generated on a wind farm that is located in County
Kerry. The proposed project was the recipient of special recognition as part of the
Novartis Corporate HSE Energy Excellence Awards during 2010. The special recog-
nition noted that
Novartis Ringaskiddy was collaborating with six neighbouring companies and that this
approach supports a more feasible size of project, gives a united approach to working
with authorities and increases awareness for the carbon-free energy source.
2011 Corporate Energy Excellence Award for Local Energy Project
Is it possible to achieve a COP in excess of 10 for a refrigeration plant?
The Coefficient of Performance (COP) is the leading key performance indicator (KPI)
for chiller efficiency. It challenged the team in Ringaskiddy to optimise the plants
chiller system with an innovative approach. As a result, they were able to reduce
electricity needs for this system by 60%.
The starting point for the project was the legal requirements on eliminating synthet-
ic HCFC refrigerants that were still in use at the site. Supported by the local energy
authorities, the team used a systematic methodology to select and design the new
chiller and as a result, decided to apply novel energy efficiency technologies. After
analysing the chilled water needs for the site, specifications for the new machine
were developed together with a number of possible vendors. The prospective sup-
pliers were challenged to propose their best technology to fulfill the specification,
instead of selecting any particular technology in the first place.
Energy consumption was

reduced by approximately
9% - from 1.36 GJ/kg
of product shipped
to 1.25 GJ/kg of product
and 2012
13
4.2 The solution chosen as a result of this rigorous process is a breakthrough combi-
WATER AND ENERGY nation of existing technologies that deliver what is now considered to be the most
CONSUMPTION energy efficient refrigeration plant in Ireland. Energy-saving technologies applied in-
(Continued) clude a single variable speed multi-piston ammonia compressor and smart control
system dedicated to ensure efficient part-load operation.
The basis for this optimisation was extensive use of monitoring data. The judging
panel noted that the systematic approach on energy management, including the
challenging of the vendors with clear and simple specifications, is definitely worth
replicating at other sites.
2012 Corporate Energy and Environment Excellence Award for Local Energy Project
Energy Recovery - Optimizing on-site incineration reduces natural gas consumption

by over 40%
Novartis Ringaskiddy Limited is one of the major chemical production plants in the
Novartis Pharma Division, covering two large production and purification facilities
and a flexible small-scale production unit. The effective combination of heat recov-
ery and waste minimization/solvent recycling enabled the site to reduce its natural
gas usage by more than 40%.
Wet electrostatic precipitation allows more lower-grade solvents to be incinerated

without exceeding emission license limits. Heat recovery from the incineration scrub-
ber is used to generate 55C hot water. The water is then fed into a site-wide low-
temperature district heating loop and used as the heat source for building heating.
As a result, the energy efficiency of air handling units can be substantially improved
and greatly reduces the need for natural gas in room heating.
The integration of waste optimization with heat recovery and low-temperature dis-
trict heating is the first project of this type in Ireland. The recovery of low-tempera-
ture heat from incineration scrubbing is an innovative and highly replicable solution
for other sites. These unique factors contributed to the viability of the project and
enabled it to be selected for financial support by the Irish government. Novartiss
investment of USD 6.5 million - supported by a 25% government grant will pay
back in 3 years.
Novartis Corporate HSE

conferred the company
with an Energy Excellence
Award in 2011
for a thought-leading
refrigeration project;
and an Energy and
Environment Excellence
Award in 2012 for an energy
optimisation project
14
Novartis Ringaskiddy Limited operates an enclosed wastewater treatment plant, which is 4.3
used to treat lightly contaminated water that is used in processing activities, in addition DISCHARGES TO
to sanitary wastewater. The effluent is treated by a mixture of physical and biological WATER/GROUNDWATER
treatment before being discharged to the Local Authoritys (Cork County Council) ma- AND SURFACE WATER
rine outfall pipeline. This pipeline services a number of local towns and industries and PROTECTION
discharges in deep water in the outer section of Cork Harbour.
There were continuing improvements recorded in discharges to water from the compa-
nys wastewater treatment plant during the period from 2010 to 2012 when compared
to the data presented in the companys last Environmental Statement. The discharges,
which are controlled under the companys Integrated Pollution Prevention and Control
Licence (IPPCL) issued by the Environmental Protection Agency (EPA), were significantly
below the regulated discharges permitted.
The relative discharge of nutrients, which can act inappropriately as fertilizers in the
aquatic environment, showed a small reduction when compared to the 2007 to 2009
data set. However, a more significant improvement was noted in the discharge of Chemi-
cal Oxygen Demand (COD), which is one of the parameters used to measure the potential
for oxygen depletion of the discharge (and which can adversely affect fish).
There was an absolute reduction of 2.8 tonnes when both three-year periods are com-
pared. This reduction built on progress that was made during the years 2007 to 2009
when an absolute decrease of 6.7 tonnes was recorded when compared to the years
2004 to 2006; and can been seen in some of the graphs in Appendix 4 at the back of
this Environmental Statement. An equally significant improvement was also noted in the
discharge of Total Suspended Solids: an absolute reduction of 5.1 tonnes when the years
2007 to 2009; and 2010 to 2010 are compared. The significance of this is that the pro-
duction portfolio and product output were broadly comparable during both three-year
periods, which indicates that real improvements have been secured.
The company undertook an evaluation of the potential benefits of upgrading the aeration
system that is used in wastewater treatment during 2012. Up to this point in time a jet
aeration/mixing system has been in use in the biological section of the wastewater treat-
ment plant. A number of vendors were assessed to determine if an alternative fine bub-
ble diffused aeration system would help the overall energy efficiency of the wastewater
treatment process. A decision was taken in late 2012 to proceed with this project, which
when implemented should result in a plant with better control of aeration that is more
energy efficient and one that requires less wastewater treatment chemical input.
Discharge of Chemical
Oxygen Demand was
reduced by 2.8 tonnes
when the years 2007
to 2009; and 2010
to 2012 are compared
15
4.3 The quality of the groundwater under the site is checked twice per annum and surface
DISCHARGES TO water (primarily rainfall) running off the site is continuously monitored. The quality of the
WATER/GROUNDWATER groundwater under the site did not change during the period between 2010 and 2012
AND SURFACE WATER when compared to the time when manufacturing activities commenced at the facility.
PROTECTION All surface water discharges were suitable for direct discharge to the local Owenabwee
(Continued) estuary during the period between 2010 and 2012.
A number of significant upgrades have been made at the facility over the past number
of years to improve both surface water and groundwater protection. Additional contain-
ment around the process lift station and the neutralisation basin in the wastewater treat-
ment plant was installed as a further safeguard to prevent any inadvertent contamina-
tion of soil or groundwater. The capacity of the companys storm water retention pond
was increased from approximately 5,000 m3 to 10,000 m3; and a new low flow transfer
station was also installed on the inflow to the storm water retention pond. The low flow
transfer station is used to automatically intercept low flows of surface water that are
flagged by data provided by continuous environmental analysers. This water is then
routed directly to the companys wastewater treatment plant. The purpose of the module
is that the maximum capacity for retaining a major spillage at the facility is maintained
at all times.
Additional improvements in respect of surface water and groundwater protection were

implemented during 2012 and these include optimising the retention volumes in the
facilitys two remote bunds (the spill basins); improving the existing bunding arrange-
ments at Warehouse Number 6; and connection of the fuel oil and glycol bunds to the
process sewer. A more comprehensive closed circuit television inspection (CCTV) of the
surface water drainage system beneath the facility was also undertaken during 2012 for
the first time; together with the implementation of an annual cleaning of both compart-
ments of the companys storm water retention pond. The inspection of the surface water
drainage system will now be added to the scheduled three-yearly inspection and test
programme for other underground pipelines at the facility.
A number of surface water protection improvement projects are scheduled to be un-

dertaken over the course of 2013/2014. These include:
Upgrading of the tiled bunded area located to the east of the equalisation tank in the
wastewater treatment plant Aaea (2013)
Repositioning of a valve set at spill basin 1 to ensure that it operates within a catch-
ment/bunded area in line with IPPC Licence requirements (2013)
Upgrading of the storm water retention pond software to include a capacity alarm
for Environmental Controls Department operators
Undertake all remedial works identified in the CCTV survey of the sites surface wa-
ter drainage system (2013)
Reinstatement of the integrity of the sanitary sewer that runs from the Sports Clubs
house that is located on the west side of the site (2014)
Discharge of Total
Suspended Solids
Installation of a new drain in the cooling tower to facilitate ease of drainage to the
was reduced by 5.1 tonnes
process sewer when testing and inspection is required (2014)
when the years 2007
to 2009; and 2010
to 2012 are compared
16
There were some very positive trends to be noted in the profile of the companys emis- 4.4
sions to air during the period from 2010 to 2012. These emissions, which are also EMISSIONS
controlled under the companys IPPCL issued by the EPA, were significantly below the TO AIR/AMBIENT
regulated emissions permitted. Such emissions arose primarily from the companys two AIR QUALITY/NOISE
natural gas fired boilers and two incinerators.
Of especial note is that the relative emission of Carbon Dioxide underwent a significant
relative reduction from 52 kg/kg of drug substance shipped in 2009 to a figure of 42 kg/
kg of drug substance shipped during 2012. Emissions of Nitrogen Oxides also showed
a positive trend over the same period: down from a relative emission of 0.04 kg/kg of drug
substance shipped in 2009 to 0.03 kg/kg of drug substance shipped in 2012.
This data can also be compared for the consecutive three-year periods between 2007
and 2009; and 2010 and 2012. The relative emission of Carbon Dioxide underwent a re-
duction from 54 kg/kg of drug substance shipped between 2007 and 2009 to 50 kg/kg
of drug substance shipped between 2010 and 2012. The relative emission of Nitrogen
Oxides underwent a reduction from 0.049 kg/kg of drug substance shipped between
2007 to 2009 to 0.047 kg/kg of drug substance shipped between 2010 and 2012.
Fugitive emissions data, which arise from a large number of small sources showed
a continuing reduction over the years 2010 and 2012 when compared to the previous
three years: down from 0.013 kg/kg of drug substance shipped between 2007 and 2009
to 0.010 kg/kg of drug substance shipped between 2010 and 2012. This was effected
through the introduction of new specific environmental targets during these years aimed
at reducing such emissions.
The significance of these reductions is that the companys production portfolio and
product output were broadly comparable during both three-year periods, which indi-
cates that real improvements in respect of emissions to air have been secured.
During 2010, 2011 and 2012 Novartis Ringaskiddy Limited participated in the second
phase of the European Union Emissions Trading Scheme (EU ETS). The overall purpose
of the scheme is to move the EU to a position where it can stabilise its emissions of
Carbon Dioxide at 1990 levels in line with the Kyoto protocol. This was the companys
eight consecutive year of participation in the scheme.
Emissions of Carbon Dioxide

underwent a significant
relative reduction from
54 kg/kg of drug substance
and 2009 to a figure
of 50 kg/kg of drug
substance shipped
a relative decrease of 7%
17
4.4 In Ireland the EU ETS is administered by the EPA and the Agency has issued the
EMISSIONS company with a Greenhouse Gas (GHG) permit (permit number GHG078-3) which is
TO AIR/AMBIENT available on the Agencys webpage at www.epa.ie. The permit came into full force at the
AIR QUALITY/NOISE beginning of 2005. The final Carbon Dioxide emission figures of 10,360 tonnes for 2010;
(Continued) 7,883 tonnes for 2011; and 6,806 tonnes for 2012 for the purposes of the second phase
of the Emissions Trading Scheme (ETS) were determined before the end of March of the
following respective years and were verified by SGS Ireland Limited. The second phase
of the EU ETS covers the years 2008 to 2012.
The figures were subsequently updated on the Emissions Trading Registry. The com-
pany had a relatively small surplus of Carbon credits for each of the three years. Note
that not all sources of the Carbon Dioxide that is generated on-site are included in the
EU-ETS, which mainly covers the companys natural gas fired boilers and light fuel oil
operated generators and pumps. The company also submitted all of the required data
during late 2011 and early 2012 to permit the issuing of a revised GHG permit to cover
the years 2013 to 2020. This was a detailed exercise that confirmed the companys sta-
tus as a relatively low greenhouse gas emitter under the terms of the EU ETS.
The company also continues to actively contribute to the local animal health sur-
veillance scheme that is run by the Veterinary Department of the Local Authority in
collaboration with the EPA. This scheme, which has been running since 1993, has not
identified any animal health issues in the Cork area that can be associated with air
emissions arising from industrial activity. The most recent report was issued during
December 2005, covers the years 2001 to 2004 and is available from the Agency. It is
anticipated that a report covering the years 2005 to 2010 will be issued by the Local
Authority in 2013.
Sound levels at the boundary of the facility have remained in compliance with the
terms of the companys planning permission and the relevant EPA Guidelines based on
the results of annual sound level monitoring that have been submitted to the Agency and
which are publicly available.
Fugitive emissions
of Organic Carbon
underwent a relative
reduction from 0.013 kg/kg
of drug substance shipped
to a figure of 0.010 kg/kg
of drug substance shipped
a relative decrease of 23%
18
Non-hazardous waste generated between 2010 and 2012 at Novartis Ringaskiddy Lim- 4.5
ited included office, cafeteria, non-contaminated glass, metal and inert absorbent wastes, NON-HAZARDOUS
wastewater treatment plant sludge and biodegradable and compostable waste. WASTE
The company has made very significant steps in the area of management of non-haz-
ardous waste over the past number of years. The total amount of non-hazardous waste
that is generated at the facility has been systematically reduced: Down from a figure
of 5.47 kg/kg of product shipped between 2007 and 2009 to a figure of 4.54 kg/kg of
product shipped between 2010 and 2012. Two waste streams account for approximately
61% of all non-hazardous waste generated at the facility (based on 2012 data): dewa-
tered wastewater treatment plant sludge (684 tonnes) and used inert absorbent (432
tonnes) both of which are now shipped on a recycle/recovery code from the facility.
On closer inspection that data indicates that the amount of non-hazardous waste seg-
regated and sent for recycling has increased by approximately 3% when the years 2007
to 2009; and the years 2010 to 2012 are compared (or an increase from a figure of
4.01 kg/kg of product shipped to a figure of 4.13 kg/kg of product shipped). In addition,
during the same period the amount of non-hazardous waste sent for final treatment or
disposal fell by approximately 73% (or a reduction from a figure of 1.46 kg/kg of product
shipped between 2007 to 2009 to a figure of 0.40 kg/kg of product shipped between
2010 and 2012.
One of the new developments in the management of non-hazardous waste at the facil-
ity during 2010 was the segregation of biodegradable and compostable waste prima-
rily waste foodstuff. This waste stream was previously landfilled. A total of approximately
five tonnes of such waste was sent for composting during 2010 and the larger amount
of approximately 10 tonnes was sent during 2011 (as the segregation initiative was only
rolled out during the middle of 2010). This work was consolidated on during 2012 when
a facility for the additional segregation for biodegradable wastes in the main cafeteria
and break areas at the facility was installed. Approximately 14 tonnes of biodegradable
waste was sent for composting in 2012.
In respect of infrastructure a new dedicated non-hazardous waste transfer station was

installed at the west side of the facility during 2011 for use by the companys contrac-
tors working on a variety of projects. The area is designed for easy segregation of metal,
timber and construction related debris and has a finished surface to help with soil and
groundwater protection.
The amount
of non-hazardous waste
generated at the facility was
reduced from 5.47 kg/kg
of product shipped to 4.54
kg/kg of product shipped
when the years 2007 to
2009; and 2010 to 2012
are compared a relative
decrease of 17%
19
4.6 Hazardous waste generated during the years 2010 to 2012 comprised mainly solvents,
HAZARDOUS WASTE but also included smaller quantities of acids, alkalis and other chemical wastes. Sig-
nificant efforts are underway to reuse/recycle as much of this material as possible. In
common with its approach to non-hazardous waste the company actively applies the
hierarchical approach to waste management of:
Avoiding waste generation (including substitution of hazardous compounds)
Reducing waste generation (through upgrading of manufacturing processes)
Reusing waste that is generated (preferably on site)
Recycling waste that is generated (preferably on site)
Recycling waste with heat recovery (preferably on site)
Treatment of waste (preferably on site)
The environmental objectives and targets for the years 2010 to 2012 included a
number of specific items targeting both the generation of hazardous waste including
implementation of the Diovan E1W process, which has resulted in significant material
input and output efficiencies for the largest volume product manufactured at the facility
during these years. The following projects were also implemented to improve hazardous
waste management at the facility:
Re-commissioning of solvent recovery column numbers 116; 117; 118; and 119 to
support more efficient solvent recovery in the Diolat process.
Improved management of waste solvent segregation to optimise the use of the re-
cently installed wet electrostatic precipitator and generate more heat from waste
on-site. The key focus of this work will be to segregate all waste distillate and mother
liquor production waste streams.
Optimisation of existing tank farm infrastructure to facilitate increased site storage

of operationally critical solvents; and management of waste solvent segregation.
The total amount of hazardous waste that is generated at the facility was reduced from
a figure of 49.22 kg/kg of product shipped between 2007 and 2009 to a figure of 44.60
kg/kg of product shipped between 2010 and 2012, which is a relative reduction of ap-
proximately 9%.
On-site solvent recovery data tells the same story. Volumes recycled increased from
a figure of 13.39 kg/kg of product shipped between the years 2007 to 2009 to 14.57
kg/kg of product shipped between the years 2010 to 2012, which is a relative increase
The amount of hazardous of approximately 8%.
waste generated at the
facility was reduced from
49.22 kg/kg of product
shipped to 44.60 kg/kg
of product shipped when
the years 2007 to 2009;
and 2010 to 2012
are compared a relative
decrease of 9%
20
Extensive landscaping was undertaken during the initial development of the facility at 4.7
Novartis Ringakiddy Limited over 21 years ago. The total site area is approximately LOCAL BIODIVERSITY
53,000 m2 of which approximately one third has been left undeveloped and used for
amenity and biodiversity purposes. Part of the landscaping involved planting a substan-
tial number of native Irish deciduous trees with the goal of recreating a native woodland
setting; and mixing this with open parkland type areas. The largest landscaped area is
located to the west of the main facility and this now incorporates a number of amenity
walkways, which are used by both employees and members of the local community. The
tree population is now well established and has transformed what was once an area that
was used primarily for agriculture. As such it provides an essential and natural counter-
balance to the large manmade structures of the company.
An initial biodiversity survey was undertaken in the autumn of 2005 by Ecological

Consultant, Tom Gittings, with a view to cataloguing the flora present in the landscaped
areas of the Novartis Ringaskiddy Limited site.
The report suggested improvements in how management of the landscaped areas

could be optimised to encourage natural biodiversity. Some of the key recommenda-
tions, to maintain and enhance the nature conservation value of the Novartis site, are
summarised below. Many of these have already been implemented.
Dry meadows and grassy verges
Annual cutting of the dry meadows and grassy verges habitat inside the security
fence in autumn, with removal of the cuttings
Conversion of areas of amenity grassland to dry meadows and grassy verges habitat
Marsh habitat
Control of willow scrub by cutting every few years
Development of semi-natural grassland and scrub buffer zone
Immature woodland
Conversion of selected areas to native woodland by gradual removal of non-native

tree and shrub species
No herbicide treatment of ground flora
Development of woodland edge habitat
The company continued to further this work during 2006 with a preliminary survey of
the breeding bird species that are present in the landscaped areas. This work was also
undertaken by Tom and led to the issue of a report that was extremely well received
across the facility.
Tom has subsequently returned to the facility on an annual basis to undertake an an-
nual breeding bird survey and has built a substantial record of the avian biodiversity that
is present in the amenity areas of the Ringaskiddy Campus.
21
4.7 Overall, the Novartis Campus has a diverse breeding bird population reflecting the
LOCAL BIODIVERSITY ecological quality of the site and enhancing the amenity experience in the landscaped
(Continued) grounds. With appropriate management as the habitats continue to develop and the
woodlands mature, additional species will colonise the Campus, further enhancing its
biodiversity
The Novartis Campus occupies a total of 53,000 m2. Of this approximately 35,000 m2
is build-up (buildings, roadways, car parks and site infrastructure); and the remaining
portion of 18,000 m2 is managed as an amenity area. The latter area forms the focus of
the on-going biodiversity studies; and the associated management plans to optimise the
potential of this area in terms of biodiversity.
2010 Biodiversity Update
Tom recorded a total of 36 species within the Novartis Campus during 2010, of which
23 were likely to be breeding wholly within the Novartis Campus. A further four species
were considered to have local breeding populations that probably make significant use
of the Novartis Campus. Another nine species were classified as occasional visitors or
non-breeding migrants. Tom also recorded three other species in areas adjacent to the
site and one other species overflying the site. Two of the species that were recorded were
the first records for the site:
A single Spotted Flycatcher on 28 May 2010. This species is a late arriving summer
migrant and this bird was probably passing through the site on migration.
A single Treecreeper on 19 June 2010. This species is associated with mature wood-
land and may breed in the Coolmore woodland belt.
Tom considered that both these species were non-breeding visitors to the site in 2010
but that they might breed in the future as the woodland habitat matures. Other changes
compared to 2009 in the breeding species were:
The occurrence again of Pheasant, Whitethroat and Linnet. These species occurred
in 2007 and 2008 but were not recorded in 2009.
The absence of Mistle Thrush.
Some species that Tom recorded as non-breeding, based on the results of his three
survey visits to the area outside the security fence, may have bred in areas within the
security.
Tom recorded seven species (Kestrel, Swift, Swallow, House Martin, Starling, House
Sparrow and Linnet) within the Novartis Campus that are now included in the amber
list of birds of conservation concern. However, one amber-listed species, the Stonechat,
which had a regular breeding population between 2006 and 2008 was not present in
2010. Tom also recorded two additional species in areas adjacent to the Novartis site
that are included in the amber list of birds of conservation concern: Stock Dove and
Skylark. All these species are widespread and common over much of Ireland. However,
Skylarks have become rare as a breeding species in the Cork Harbour area and Stock
Doves may be scarce in the Ringaskiddy area.
22
2011 Biodiversity Update 4.7

LOCAL BIODIVERSITY
Tom recorded a total of 33 species within the Novartis Campus during 2011, of which (Continued)
21 were likely to be breeding wholly within the Novartis Campus. A further six species
were considered to have local breeding populations that probably make significant use
of the Novartis Campus. Another six species were classified as rare occasional visitors or
non-breeding migrants. Tom also recorded two species in areas adjacent to the site and
one other species overflying the site. One of the species that Tom recorded, the Reed
Bunting, was his first record for the site.
Tom noted some changes compared to 2010 in the breeding species that included:
The occurrence again of Mistle Thrush. This species occurred during the years 2007
to 2009 but was not recorded in 2010.
The absence of Stock Dove and Linnet.
Some species that Tom recorded as non-breeding, or which he did not record, based
on the results of his three survey visits to the area outside the security fence, may have
bred in areas within the internal security fence.
Tom recorded six species (Swift, Swallow, House Martin, Starling, House Sparrow and
Linnet) within the Novartis Campus that are now included in the amber list of birds of
conservation concern. However, one amber-listed species, the Stonechat, which had a reg-
ular breeding population in the years 2006 to 2008, was not present in 2011. Tom also
recorded one additional species, the Skylark, in areas adjacent to the Novartis campus,
that is included in the amber list of birds of conservation concern. All these species are
widespread and common over much of Ireland. However, as noted in the 2010 survey
Skylarks have become rare as a breeding species in the Cork Harbour area.
23
4.7 2012 Biodiversity Update

LOCAL BIODIVERSITY
(Continued) In 2012 Tom recorded 29 species within the Novartis Campus of which 22 were likely to
be breeding wholly within the Novartis Campus. A further four species had local breeding
populations that probably made significant use of the Novartis Campus. Another three
species were occasional visitors or non-breeding migrants. Tom also recorded one addi-
tional species adjacent to the Campus and seven other species overflying the Campus.
Changes compared to 2011 in the breeding species included:
The absence of Mistle Thrush. This species occurred during the years 2007 to 2009;
and 2011.
The occurrence of Whitethroat apparently holding territory in along the hedgerows

in the eastern section of the Campus.
Some species that Tom recorded as non-breeding, or which he did not record, based
on the results of the three 2012 survey visits to the area outside the security fence, may
have bred in areas within the security fence.
The commonest species in 2012 was the Wren, followed by Chaffinch, Swallow, Robin
and Blackbird. The numbers of each species recorded in the 2010 to 2012 point count
surveys are compared in the accompanying table. Most species occurred in numbers
around, or above, the five-year mean. Compared to the five-year mean, the number of
ground-feeding insectivores and tree and shrub feeding insectivores were lower, with
the latter mainly due to low numbers of resident species. The numbers of seedeaters
were higher, but this was due to a flock of Linnets on the third visit that was feeding in
the rapeseed crop adjacent to the Campus and was probably not breeding within the
Campus. Compared with the original 1991 to 1992 baseline data, the numbers of all
guilds were higher.
In 2012 Tom recorded three species (Swift, Swallow and Linnet) within the Novartis
Campus that are now included in the amber list of birds of conservation concern. How-
ever, one amber-listed species, the Stonechat, which had a regular breeding population
in the years 2006 to 2008, was not present in 2012. Tom also recorded one additional
species, the Skylark, in areas adjacent to the Novartis Campus that is included in the am-
ber list of birds of conservation concern. All these species are widespread and common
over much of Ireland. However, as noted in the surveys of 2010 and 2011 Skylarks have
become rare as a breeding species in the Cork Harbour area.
24
Bird species recorded at the Novartis Ringaskiddy campus
during the surveys between 2010 and 2012 and their likely breeding status
Species Scientific name 2012 Status1 2011 Status1 2010 Status1

Little Egret Egretta garzetta overflying not recorded not recorded
Grey Heron Ardea cinerea overflying not recorded not recorded
Cormorant Phacrocorax carbo overflying not recorded not recorded
Shelduck Tadorna tadorna overflying not recorded not recorded
Mallard Anas platyrhynchos not recorded overflying overflying
Pheasant Phasianus colchicus breeding (part) breeding (part) adjacent
Sparrowhawk Accipiter nisus not recorded not recorded non-breeding
Kestrel Falco tinnunculus not recorded not recorded non-breeding
Moorhen Gallinula chloropus not recorded not recorded not recorded
Lesser Black-backed Gull Larus fuscus overflying not recorded not recorded
Herring Gull Larus argentatus overflying not recorded not recorded
Stock Dove Columba oenas overflying not recorded adjacent
Woodpigeon Columba palumbus breeding breeding breeding
Collared Dove Streptopelia decaocto breeding (part) breeding (part) breeding (part)
Swift Apus apus non-breeding non-breeding non-breeding
Skylark Alauda arvensis adjacent adjacent adjacent
Swallow Hirundo rustica breeding breeding breeding
House Martin Delichon urbica not recorded breeding (part) breeding (part)
Meadow Pipit Anthus pratensis breeding breeding breeding
Pied Wagtail Motacilla alba breeding adjacent breeding
Wren Troglodytes troglodytes breeding breeding breeding
Dunnock Prunella modularis breeding breeding breeding
Robin Erithacus rubecula breeding breeding breeding
Stonechat Saxicola torquata not recorded not recorded not recorded
Species Scientific name 2012 Status1 2011 Status1 2010 Status1
Blackbird Turdus merula breeding breeding breeding
Song Thrush Turdus philomelos breeding breeding breeding
Mistle Thrush Turdus viscivorus not recorded breeding (part) not recorded
Whitethroat Sylvia collybita breeding (part) non-breeding non-breeding
Blackcap Sylvia atricapilla breeding breeding breeding
Chiffchaff Phylloscopus collybita breeding breeding breeding
Willow Warbler Phylloscopus trochilus not recorded not recorded non-breeding
Goldcrest Regulus regulus breeding breeding breeding
Spotted Flycatcher Muscicapa striata not recorded not recorded non-breeding
Treecreeper Certhia familiaris not recorded non-breeding non-breeding
Long-tailed Tit Aegithalos caudatos breeding breeding breeding
Coal Tit Parus ater breeding breeding breeding
Blue Tit Parus caeruleus breeding breeding breeding
Great Tit Parus major breeding breeding breeding
Magpie Pica pica breeding breeding breeding
Jackdaw Corvus monedula breeding breeding breeding
Rook Corvus frugilegus breeding (part) breeding (part) breeding (part)
Hooded Crow Corvus corone cornix non-breeding non-breeding non-breeding
Starling Sturnus vulgaris not recorded non-breeding non-breeding
House Sparrow Passer domesticus not recorded breeding (part) breeding (part)
Chaffinch Fringilla coelebs breeding breeding breeding
Greenfinch Carduelis chloris breeding breeding breeding
Goldfinch Carduelis carduelis breeding breeding breeding
Linnet Carduelis cannabina non-breeding not recorded breeding
Redpoll Carduelis flammea not recorded not recorded not recorded
Bullfinch Pyrrhula pyrrhula breeding breeding breeding
Reed Bunting Emberiza schoeniclus not recorded non-breeding not recorded
25
5 SOCIAL PERFORMANCE and CORPORATE RESPONSIBILITY
5.1 As a pharmaceutical company and a member of the Novartis Group of companies, No-
CORPORATE vartis Ringaskiddy Limited is fully committed to Corporate Responsibility. Corporate Re-
RESPONSIBILITY POLICY sponsibility at Novartis worldwide is an integral part of how the company operates and
is a key to its success. Novartis believes that Corporate Responsibility is the right thing
to do and essential to maintaining the companys license to operate, innovate and grow.
Through responsible business, Novartis endeavours to create value for society. Corporate
Responsibility commitment at Novartis rests on five pillars: Patients, associates, share-
holders, healthcare partners, and society.
Patients
Novartis is committed to creating value for all patients including those who cannot
afford treatment. The company has specific requirements in relation to patient benefit
and safety; research and development; product quality and safety; and access to health-
care. In all Novartis research activities the company strives to ensure the rights, safety
and wellbeing of all participants. Compromising patient benefit or safety is not an option.
When the company has to use animals for research purposes it is committed to mini-
mising their discomfort and pain. Novartis will use alternatives to animal research when-
ever possible. The company discovers, develops and manufactures high-quality products
that meet all regulatory requirements, and pursues quality beyond compliance in both
Novartis products and processes. As a healthcare company, the companys primary re-
sponsibility is to discover and develop new products to prevent and cure diseases. With
collaborators around the world, it also works to enhance access to healthcare for patients
through medical research, new business models and actions to strengthen healthcare
systems in both developing and advanced economies.
26
Associates 5.1
CORPORATE
Novartis has specific requirements in relation to looking after the well-being of its as- RESPONSIBILITY POLICY
sociates. These include requirements in respect of fair working conditions; diversity and (Continued)
inclusion; associate appraisal and development; and freedom of opinion, speech and
association. The company is committed to providing its associates fair and competitive
wages based on performance and ethical conduct. It treats its associates fairly, equally
and respectfully. In return it expects associates to demonstrate respect toward each
other and the company does not tolerate any form of harassment or discrimination. No-
vartis seeks to create an inclusive work environment where associates regardless of their
backgrounds can contribute fully. The company appreciates the diversity and individual-
ity of its associates and does not discriminate based on personal characteristics such
as nationality, gender, age, ethnicity, religion, sexual orientation or disability. Novartis
believes that a diverse workforce that reflects the global community of our patients and
customers is critical to its success. The company offers opportunities for its associates
to develop, grow and continuously improve individual skills to strengthen the competen-
cies of Novartis as a whole. The company respects the right of associates to choose to
join an association, provided that local law is respected. Novartis engages in constructive
dialogue with associates and their representatives. It recognises that every associate is
entitled to freedom of opinion, expression and speech, provided these do not interfere
with the associates ability to fulfil their job responsibilities or conflict with the Novartis
Code of Conduct.
Shareholders
Novartis has specific requirements in relation to supporting the interests of its share-
holders. These include requirements in respect of financial integrity, business continuity,
safeguarding of corporate assets, information security and avoiding conflicts of interest.
The company provides timely, accurate and complete financial information to its share-
holders and financial markets. It maintains effective controls over financial reporting to
ensure a complete and accurate record of its financial transactions. Novartis believes
that business continuity management is critical for its patients, customers, associates
and other stakeholders, and is part of responsible management practice. In the event
of an emergency or significant business disruption, the company is committed to doing
its utmost to ensure uninterrupted supply of key products and services. The company
works to protect assets of Novartis against threats. This applies to its associates, repu-
tation, intellectual property, information, products, property and other assets. Novartis
protects the confidentiality, integrity and availability of critical information, regardless of
its form and location. Personal interests must not influence the business judgment or
decision making of Novartis associates.
27
5.1 Healthcare Partners

CORPORATE
RESPONSIBILITY POLICY Novartis has specific requirements in relation to its dealings with its healthcare part-
(Continued) ners. These include requirements in respect of customer satisfaction, anti-bribery and
corruption, fair competition, marketing practices and commitment to all laws and regu-
lations. The company strives for the highest customer satisfaction. It listens to its cus-
tomers and creates solutions that add value and create mutual benefit for them and for
Novartis. The company does not tolerate any form of bribery or corruption. Novartis is
committed to fair competition and will not breach competition laws and regulations. The
company markets and sells its products in compliance with all applicable rules and regu-
lations, and in line with high ethical standards. This commitment also applies to all its
other activities relating to the commercialisation of its products, such as the collection
and communication of medical and other information. Novartis complies with all laws
and regulations applicable to its activities. The company also implements and complies
with its own internal policies. Novartis expects third parties with whom it works with to
comply with the law, to adhere to ethical business practices, and to observe its standard
requirements concerning labour, health, safety, environmental protection and manage-
ment systems.
Society
Novartis has specific requirements in relation to societal wellbeing. These include re-
quirements in respect of Corporate Responsibility; transparency; human rights; data pri-
vacy; and health, safety and environmental protection. By actively contributing to social,
ecological, cultural, and other projects and programmes, Novartis strives to contribute to
the solution of societal problems. It is committed to the United Nations Global Compact,
the worlds largest Corporate Citizenship initiative. Novartis is open and transparent with
respect to its business principles and practices and complies with all applicable laws and
regulations. The company strives to ensure that activities within its sphere of influence
do not negatively impact fundamental human rights, as set out by the United Nations
Bill of Rights and the core conventions of the International Labour Organisation, either
directly or through the companys business relations. Novartis respects the privacy rights
of its associates, patients, physicians, and other stakeholders.
28
Novartis strives to be a leader in all aspects of occupational health, safety and envi- 5.1
ronmental protection. The company systematically identifies and manages health, safety CORPORATE
and environmental risks in its activities and over the entire value chain of its products RESPONSIBILITY POLICY
and services. Novartis proactively fosters and encourages a strong culture of safe behav- (Continued)
iour. The company makes efficient use of natural resources and minimises the environ-
mental impact of its activities and products over their life cycle.
A general overview of the Novartis approach to Corporate Responsibility can be

found at:
http://www.novartis.com/corporate-responsibility/index.shtml
A copy of the Novartis Policy on Corporate Responsibility and the Novartis Code of Con-
duct is available at:
http://www.novartis.intra/downloads/about-novartis/
code-of-conduct/code-of-conduct-english.pdf
We aspire to be the worlds most respected and successful healthcare company. We can only
realise this aspiration if we earn and maintain the trust and support of our key stakeholder groups:
our patients, our associates, our shareholders, our healthcare partners, and society at large.
Joerg Reinhardt, Chairman, Novartis

Joseph Jimenez, CEO, Novartis
29
5.2 Community Partnership Day is an annual day of service celebrated by Novartis employ-
COMMUNITY ees worldwide. Usually held in April, Community Partnership day gives Novartis associ-
PARTNERSHIP DAY ates the chance to support the communities in which they live and work. This is a unique
event in that nearly every Novartis location worldwide participates at the same time
demonstrating on one day our personal commitment to Corporate Responsibility by
helping the communities closest to us.
Community Partnership Day at Novartis Campus in Ringaskiddy has grown in impor-

tance and popularity over the years with more and more associates participating each
year. A key feature is also the contribution made by many of the companys contractors.
Consequently our personal contact with local communities has grown stronger over the
years. Community Partnership Day gives employees at the Novartis Ringaskiddy campus
a real opportunity to make a difference in the lives of some of the companys most im-
portant stakeholders the people who live and work in the communities nearby.
The following Six projects were undertaken during

Community Partnership Day 2010:
Annual Senior Citizens Invitational Lunch
The 2010 annual lunch for local senior citizens proved to be another great success.
Senior citizens from the community were invited to the Novartis campus where Gerry
and his team in the cafeteria treated them to a delicious four-course meal. Music and
dancing followed and guests left in a jubilant mood counting the days until next year.
Mahon Youth Center, Mahon, Cork
The Mahon Youth Network provides essential services for at risk young people and
provides educational and recreational support. Thanks to the efforts of the Novartis as-
sociates the centre now has a renovated building that will help bring more young people
in to avail of its services.
Brothers of Charity Center, Douglas, Bishopstown, Cork
The Novartis volunteers faced a disused and fairly dilapidated space and had one day
to transform it into a usable indoor soccer hall. From repairing and painting the floor to
fixing the lighting and making the hall suitable for use, the associates involved did an
amazing job.
30
Local Area Tidy Up Shanbally and Ringaskiddy Villages 5.2

COMMUNITY
In the two years leading up to 2010 Novartis associates from the Ringaskiddy Campus PARTNERSHIP DAY
participated in a local area tidy-up of the local villages of Shanbally and Ringaskiddy and (continued)
also the local external environs of the Campus. So on the morning of the 22nd of April
the Novartis troops again headed off on foot early in the morning to do a round-up of any
unwanted rubbish or litter in the local area. With the County Council on call for collection
and the support of the Local Residents Association, this was a great exercise, building
relationships across both neighbouring communities. It was an exceptionally busy morn-
ing with associates collecting litter on foot, and also driving around and collecting bags
for delivery to a drop zone for the Council pick up! This was a great local initiative and
tremendous effort by everyone involved.
Cork Mental Health Housing Association, Cork
The Cork Mental Health Housing Association was one of the beneficiaries of the 2010
Novartis Community Day. Work on this project included painting, gardening and outdoor
lighting. The day was a great success and Brendan McCarthy, Development Manager of
the Association, in thanking all of the volunteers who took part said I would like to thank
you all for your excellent work which will have a very positive impact on the residents
health and well-being.
Cork Simon Community, Cork
The work at the Cork Simon Project saw work on the garden of the centre and the
refurbishment of the some of the rooms inside. Making the garden a centre of calm and
relaxation for the residents, and helping to make the rooms themselves more like a home
was a great contribution for Cork Simon.
31
5.2 The following five projects were undertaken during

COMMUNITY Community Partnership Day 2011:
PARTNERSHIP DAY
(continued) Annual Senior Citizens Invitational Lunch
The 2011 annual lunch for local senior citizens proved to be another great success.
Senior citizens from the community were invited to the Novartis campus where Emer
Moran and Mary Magner along with their teams of volunteers and the Sodexo staff in the
cafeteria treated them to a delicious four-course meal. Music and dancing followed and
both guests and volunteers left in a jubilant mood counting the days until next year.
Local Area Tidy Up Shanbally and Ringaskiddy Villages
In the three years leading up to 2011 Novartis associates from the Ringaskiddy Cam-
pus participated in a local area tidy-up of the local villages of Shanbally and Ringaskiddy
and also the local external environs of the Campus. So on the morning of the 14th of April
the Novartis volunteers under the able direction of Dieter Spoerri set off on foot early in
the morning to do a round up of any unwanted rubbish or litter in the local area. With the
County Council on call for collection and the support of the Local Residents Association,
this was a great exercise, building relationships across both neighbouring communities. It
was an exceptionally busy morning with associates collecting litter on foot, and also driving
around and collecting bags for delivery to a drop zone for the Council pick up! As in previ-
ous years this was a great local initiative and a tremendous effort by everyone involved.
The Sundays Well Life Centre, Sundays Well, Cork
The Sundays Well Life Centre is a voluntary organization that offers one-to-one educa-
tion, counseling and support for early school leavers. Paul Downey and the team of vol-
unteers put in a great days work for this very deserving organisation. The team worked
on carpentry, plumbing and lots and lots of painting.
32
Ringaskiddy Lower Harbour National School, Ringaskiddy, County Cork 5.2

COMMUNITY
Lorcan Aherne and his team did a great days work in helping to upgrade the schools PARTNERSHIP DAY
staffroom. The team undertook general cleaning duties, sanding and varnishing and (continued)
painting on the day.
Cork Penny Dinners, Little Hanover Street, Cork
Cork Penny Dinners is one of Cork Citys oldest and independent caring organisations.
It offers a nourishing midday meal to those in need in exchange for a small coin. This
project, which was headed up by Stephen Crowley and John Fitzgibbon, had one of the
biggest team of volunteers on Community Partnership Day 2011. The volunteers car-
ried out decoration and repair work to help improve the Cork Penny Dinners premises
in Little Hanover Street. The volunteers also served soup and sandwiches to Cork Penny
Dinners clientele on the day.
The following four projects were undertaken during

Community Partnership Day 2012:
Annual Senior Citizens Invitational Lunch
Senior citizens from the community were once again invited to the Ringaskiddy Cam-
pus where Emer Moran and Mary Magner along with their teams of volunteers from
both Novartis and Alcon; and the Sodexo staff in the cafeteria treated them to some fine
cuisine and some great entertainment. By noon the guests started to arrive and meet
up with their friends and acquaintances from the locality. Orders were taken and lunch
was served by the volunteers, which resulted in some very happy guests and a highly
charged atmosphere for the by now traditional game of Pongo. Fuelled with trifle and
meringue the singing and dancing kicked off! The advance organisation and preparation
that the organisers had put into the event coupled with the enthusiastic volunteers was
evident in the many thank yous received from the departing guests as they picked up
their goodie bags.
Nagle Community College, Mahon, Blackrock, Cork
Nagle Community College is a centre of education that encourages holistic develop-

ment in a caring and respectful environment. This 2012 Community Partnership Day
project was coordinated by Mark Finglas and involved a team of some 15 associates in
the creation of a sensory garden as part of the Colleges programme for children with
autism. The busy programme involved installation of a water feature; lighting; weeding
and planting; some additional electrical work; and also a general tidy-up.
33
5.2 St. Lukes Home, Castle Road, Mahon, Cork

COMMUNITY
PARTNERSHIP DAY St. Lukes Home is a well-respected and leading provider of residential care and
(continued) support services to older people in the Cork region. On a fine day for outdoor work
associates from the Ringaskiddy Campus joined forces with colleagues from the Alcon
Division of Novartis to work on the creation of a sensory garden for the newly built De-
mentia Unit in St. Lukes Home as part of Community Partnership Day 2012. Under the
supervision of the project leader Stephen Crowley the volunteers were split into teams,
each tasked with a specific area of the garden to complete. The teams were comprised
of two Alcon associates plus six to eight Novartis associates with each Alcon associate
partnered by a Ringaskiddy Campus associate, which really contributed to an open,
friendly and most importantly productive atmosphere. In addition to the main scope of
work on the sensory garden the associates also did some electrical work and undertook
a general tidy-up.
Local Area Tidy Up, Shanbally and Ringaskiddy Villages
Under the able direction of Kline Pennefather the Ringaskiddy Campus volunteers
headed off on foot early in the morning to do a round-up of any unwanted rubbish or
litter in the immediate vicinity of the plant and also the approach routes to the nearby
villages of Shanbally and Ringaskiddy. Thankfully the weather was good for this outdoor
project. Cork County Council was on call for collection of the not insignificant amount of
refuse collected; and additional support was provided by the Local Residents Associa-
tion. A key feature of the day was the participation of a class from Shanbally National
School, which brought a new and energetic dimension to this annual project. As in previ-
ous years this was a very worthwhile and enjoyable project to participate in and there
was a palpable buzz as the volunteers scoured the highways and byways in search of the
litter that can be such a problem in quiet communities
34
6 ENVIRONMENTAL MANAGEMENT SYSTEM
The task of minimising the impact of Novartis Ringaskiddy Limiteds activities on the 6.1
environment is borne by all of the companys employees at all levels in accordance ENVIRONMENTAL
with their function, authority, knowledge and training. The responsibilities for day-to-day MANAGEMENT
operation of environmental protection equipment and the day-to-day monitoring of the
environmental performance of the site as a whole have been assigned to two separate
Support Units (Departments) at Novartis Ringaskiddy Limited.
The Technical Services Support Unit is responsible for operation of the companys
wastewater treatment plant, solvent recycling equipment, surface water protection sys-
tem and incinerators. This Support Unit also co-ordinates the collection system for paper,
plastic, glass and metal recycling; and food waste for composting. The Technical Services
Plant Manager is responsible for carrying out this work in association with a number of
engineers, operators and craftpersons. Other members of the Technical Services Support
Unit provide additional support to the Technical Services Plant Manager.
The Health, Safety and Environment (HSE) Support Unit is responsible for monitoring
environmental performance at Novartis Ringaskiddy Limited. This includes monitoring
the performance of environmental protection equipment, the local environment and also
other items of equipment on-site, for example, the utility boilers, which are operated on
natural gas. Working out of a specially designed Environmental Laboratory, the Environ-
mental and Industrial Hygiene Services Group oversee the hundreds of analyses which
are carried out on a daily basis. It is noteworthy that the number of regulatory environ-
mental tests increased by approximately 8% over the three years covered by this Envi-
ronmental Statement to a figure of greater than 230,000 tests per annum. A significant
portion of this activity is highly automated and computerised.
The HSE Support Unit is also responsible for reporting environmental performance to
the EPA under the terms of the companys IPPCL. The most recent revision of the com-
panys IPPCL (Register Number P0006-03) was issued on 02-Feb-2006 and is available
on the EPAs website
http://www.epa.ie
The IPPCL, together with the Novartis Corporate Responsibility Code of Conduct and
other policies and guidelines, Corporate HSE guidelines and guidance notes and the
companys own HSE Policy, defines the minimum environmental performance against
which Novartis Ringaskiddy Limiteds activities are assessed.
The HSE and Technical Services Support Units make use of a computerised Document
Management System because of the necessity to record and store information related
to Environmental Management Activities. This system allows the writing, approval, stor-
age and retrieval of the Standard Operating Procedures which are used by both Support
Units and a number of other Process Units and Support Units on-site.
Computerised storage of test data is also carried out at Novartis Ringaskiddy Limited.
This allows inspection of past environmental performance and also indicates any trends,
which may necessitate taking appropriate action before a problem occurs in the opera-
tion of environmental protection equipment. The company utilises a computerised sys-
tem for scheduling and implementing preventative maintenance. This system is referred
to by its proprietary name of Maximo. This system will be superceded by a SAP based
system in 2013.
35
6.2 Novartis Ringaskiddy Limited operates under the EPAs Integrated Pollution Prevention
IPPC LICENCE and Control regime. The company submitted an eight volume application for its original
IPPCL. This documentation, which is available to the public, provides a comprehensive
overview of Novartis Ringaskiddy Limiteds approach to environmental protection.
In addition to committing itself to meeting the strict requirements of the original IPPCL,
Novartis Ringaskiddy Limited also successfully undertook the many programmes arising
from the original licence and the subsequently issued revisions. These included:
Site Environmental Management Programme (EMP)
Site Pollution Emission Register
Programme for Reduction of Fugitive Emissions
Public Access to Information
Noise Reduction Programme
Wastewater Effluent Studies
Regular Reports on Emission Monitoring
Conducting detailed energy audits
Preparation of an Environmental Liability Risk Assessment
Preparation of a Residuals Management Plan
Many of these programmes are revised on an annual basis and the information re-
quired to support all of the programmes is updated on an on-going basis with the results
made available to the public.
As noted above two revisions have been made to the company's original IPPCL (Reg-
ister Number P0006-01). The first revision (IPPCL Register Number P0006-02) was
issued on 31-Oct-2000; and the second revision (IPPCL Register Number P0006-03)
was issued on 02-Feb-2006). All of the programmes arising from the issue of the revised
IPPCLs have been implemented. The company anticipates submitting documentation to
the EPA in 2013 to permit the transition of the existing IPPCL to an Industrial Emissions
Directive compliant licence.
6.3 Novartis Ringaskiddy Limited prepares an annual revision to the site EMP. This document
ENVIRONMENTAL summarises progress in meeting the previous years environmental objectives in addi-
MANAGEMENT tion to defining new objectives for the coming year.
PROGRAMME
The original EMP has been updated seventeen times (annual updates), with the revi-
sions being forwarded to the EPA prior to implementation. An annual report on the im-
plementation of the EMP is also prepared and forwarded to the Authorities.
36
The primary responsibility for auditing the companys environmental performance rests 6.4
with the HSE Support Unit. As outlined in the previous section describing Environmental ENVIRONMENTAL
Management at Novartis Ringaskiddy Limited, this Support Unit operates independently AUDITING
of the Support Unit that is responsible for the day-to-day operation of environmental
protection equipment and the Functions responsible for production.
The results from such auditing activities are used both to maintain and, where pos-
sible, improve the companys environmental performance and to form the basis of the
environmental compliance reports that the company is required to submit to the EPA
under the terms of the companys IPPCL.
Corporate audits by Novartis HSE auditors take place at intervals no longer than three
years. Novartis personnel who are completely independent of the site carry out these
audits.
Sandoz Group Safety and Environmental Protection auditors (prior to the formation
of Novartis) were responsible for conducting the initial environmental review of the facil-
ity at Ringaskiddy. This review provided a comprehensive analysis of the environmental
issues, impact and performance at the site. These auditors were also responsible for
performing the first environmental audit of the site to ascertain compliance with the
EMAS Regulation. The initial environmental review document was subsequently updated
during 2006; and is now revised on an annual basis to ensure an on-going evaluation of
the companys non-significant and significant direct and indirect environmental aspects
and impacts.
By participating in the EMAS scheme, Novartis Ringaskiddy Limiteds Environmen-

tal Statement has to be validated, at a minimum every three years, by an accredited
and nationally recognised verifying organisation. During 2010 and 2011 the contents
of the companys annual Interim Environmental Statements were also independently
validated.
The EPA audits the company on a regular basis. Representatives of the EPA also take
routine, unannounced, samples from all of the sites main emission points for independ-
ent analysis.
37
6.5 To ensure that the company is in a position to meet its legal and corporate environmental
ENVIRONMENTAL requirements Novartis Ringaskiddy Limited maintains three environmental registers:
REGISTERS
The Register of Environmental Effects and Significant Environmental Effects
This register systematically documents information relating to those aspects of the

companys operations that present the potential for having a significant effect on the
environment.
The Register of Environmental Legislation
The company maintains an up-to-date web-based register of all relevant environmen-

tal legislation on-site. This register is updated on frequent basis as legislation is enacted;
is tailored to reflect the companys environmental aspects and impacts; and is readily
available to all interested employees.
The Register of Environmental Communication
The purpose of this register is to document internal and external communication in

relation to environmental issues, which tends to be primarily with the regulatory authori-
ties.
6.6 At a corporate level, Novartis AGs HSE Group prepares the internal environmental Guide-
CORPORATE lines and Guidance Notes that are applied throughout the entire Novartis Group of compa-
COMMITMENT nies. These Guidelines have the full backing of the Executive Board.
Novartis Ringaskiddy Limited has implemented and adapted the Novartis Corporate
Responsibility Code of Conduct and the associated policies and guidelines at a site level
(where relevant).
6.7 Novartis Ringaskiddy Limited spent a total of 9,115,841 on HSE investments during
INVESTMENTS 2010 of which 5,702,600 were related to environmental protection; 3,835,767 during
AND EXPENDITURES 2011 of which 665,850 were related to environmental protection; and 6,954,855 dur-
IN SAFETY AND ing 2012 of which 3,370,630 were related to environmental protection.
ENVIRONMENTAL
PROTECTION Day-to-day HSE related running costs during 2010 amounted to 11,475,354 of which
9,666,670 were related to environmental protection; 11,949,182 during 2011 of
which 10,164,513 were related to environmental protection; and 14,950,104 during
2012 of which 13,177,572 were related to environmental protection.
CAPITAL SPENDING FOR OPERATIONAL SPENDING FOR

ENVIRONMENTAL PROTECTION (1,000 ) ENVIRONMENTAL PROTECTION (1,000 )
38
To ensure that real progress is made towards meeting the companys environmental 6.8
obligations and objectives a Site Environmental Committee meets every two months. SITE ENVIRONMENTAL
This multi-discipline group forms an effective focus for addressing issues arising from COMMITTEE/TECHNICAL
internal and external environmental audits, new corporate environmental regulations COORDINATION
and strategies; new EPA requirements, monitoring site environmental targets and estab- COMMITTEE/SITE ENERGY
lishing new site environmental objectives to name but a few. MANAGEMENT GROUP
The Technical Coordination Committee is the group responsible for overseeing the
implementation of various projects on-site - including those related to environmental
protection. This group meets on a monthly basis.
The Site Energy Management Group also meets on a monthly basis. The focus of this
group is to oversee the implementation of energy saving initiatives and projects; and to
develop proposals for new energy conservation measures.
All three groups have a number of representatives of higher management present to

ensure that the necessary resources can be allocated to implement new initiatives in the
area of environmental protection.
Novartis Ringaskiddy Limited has maintained an open two-way dialogue with local resi- 6.9
dents since the inception of the project at Ringaskiddy. ENVIRONMENTAL
COMMUNICATION
The companys Environmental Statements and Interim Annual Environmental State-
ments prepared to meet the requirements of the EMAS Regulation are freely available
to all interested parties. These reports are specifically designed to summarise the large
volume of technical data which Novartis Ringaskiddy Limited generates to assess its
environmental impact in an easily understandable format.
Novartis Ringaskiddy Limited reports more than 230,000 environmental measure-

ments to the EPA on an annual basis. Many other environmental reports are also submit-
ted to the EPA. All of this information is available to the public - either at the facility itself
or through the EPA.
In addition to making this information available to its employees, regular monthly up-
dates on environmental performance are made available to all employees via a shared
computer drive. The minutes of the Site Environmental Committee and the Site Energy
Management Group are also freely circulated, primarily by e-mail to keep employees
informed on new environmental issues that may affect the companys operations.
The companys HSE Policy is communicated to all employees at induction training;

and updates are communicated through the minutes of the Site Environmental Commit-
tee and via the companys internal e-mail system. A copy is also available to employees
via the HSE Support Units internal webpage.
39
6.10 Novartis Ringaskiddy Limited falls into the category of industrial activities covered under
EMERGENCY the Major Accident Hazards of Certain Industrial Activities Regulations (the so-called
MANAGEMENT Seveso Directive), the quantities and nature of materials stored at the facility are at the
level at which the more serious provisions of the regulations come into force.
During 2000 Novartis Ringaskiddy Limited prepared a Major Accident Prevention Pol-
icy (MAPP) document to meets its requirements under the Control of Major Accident
Hazards Regulations, 2000 (S.I. Number 476 of 2000). This document was finalised
towards the end of 2001 and forwarded to the relevant competent body in the State, the
Health and Safety Authority (HSA).
Subsequent to this the company prepared a Safety Report in anticipation of (the then)
future requirements arising under the Control of Major Accident Hazards Regulations
2000, which were subsequently updated to the European Communities (Control of Major
Accident Hazards Involving Dangerous Substances) Regulations, 2006 (S.I. Number 74
of 2006). This Safety Report was forwarded to the HSA during 2010. This was reviewed
and approved by the HSA during 2011.
A full update to the Safety Report is required for any major changes to the facility
that may impact on the risk presented both on- and off-site; or every five years. In the
absence of any major change at the facility the next full update of the Safety Report was
undertaken during 2012. It is anticipated that this document will be issued; and then
reviewed and approved by the HSA during 2013.
A copy of the revised Safety Report is retained on site for inspection both by the HSA
and the EPA.
Novartis Ringaskiddy Limited has examined the risks to public safety that could arise
from fire, explosion or another emergency at the plant. Taking into account all aspects
of the operation the company does not consider that there are any likely circumstances
in which an accident at the plant could pose a significant risk to the safety of local resi-
dents.
This judgement is based on the nature and quantities of materials stored on the site as
well as the very high standard in respect of safety and environmental protection installed
at the facility.
Protection against process upset has been incorporated into the design of the plant
using the concept of Superimposed Safety. This means that processes are automati-
cally monitored at a number of different points, which permits the computerised control
system to take immediate action, for example, in the event of an unexpected rise in
temperature. Processes involving the use of bulk flammable liquids are carried out in the
absence of oxygen as a protection against fire and explosion.
40
To complement this very specific protection system the company has implemented a 6.10
hierarchy of three additional protective measures: EMERGENCY
MANAGEMENT
Structural protection which physically prevents the spread of fire. This includes use (Continued)
of specially constructed fire walls, fire doors and fire seals.
Automatic fire fighting protection which is employed should excessive heat be de-
tected. This includes the site wide sprinkler system, water deluge system and foam
deluge systems.
Automatic protection is augmented by early warning and detection systems for fire,
excessive heat, smoke, spillages and/or process specific problems which enable
manual intervention at an early stage should this be required. Situations where
rapid decision making is necessary, to prevent serious environmental impact, have
been identified to ensure that adequate control measures are in place.
The use of closed production systems, containment, bunded areas, two spill basins and
a storm water retention pond at Novartis Ringaskiddy Limited ensures that chemicals,
including water used to extinguish fires, are kept within the premises under all envisaged
circumstances, and prevent any direct contact with persons or animals nearby.
The bunding of the bulk chemicals stored on site is as specified in the US National Fire
Protection Association Code 30 on the Storage of Flammable Liquids which follows the
best international practice in this regard. Warehousing on-site complies with a Novartis
Corporate Guideline, which represents best international practice. The Guideline incor-
porates such elements as:
Segregation of chemicals according to their individual properties and inherent risks.
Provision for the containment of chemicals in the event of spillage.
Use of automatic systems to detect spillages.
Provision for the extinguishing of fires by appropriate means.
Training of personnel.
Security and regular inspection.
Prior to commencement of trial production during the latter half of 1994, Sandoz Rin-
gaskiddy Limited put in place its Local Emergency Management (LEM) strategy, which
was implemented in the event of an incident. This system was subject to routine drilling
at the facility, including visits by and drills with the Local Authority Emergency Services.
Following the formation of Novartis this system has now been renamed the Novartis
Emergency Management (NEM) strategy. In this respect the company pioneered the
concept of a special contact telephone number, which is only available to local residents,
in the Ringaskiddy area. This number allows the company's neighbours to be updated by
a specially trained Public Information Team on an incident without any undue delay.
41
7 ENVIRONMENTAL OBJECTIVES
7.1 INTRODUCTION Novartis Ringaskiddy Limited is convinced that the Environmental Management System
(EMS) that it has in place delivers the highest standards in environmental protection.
Novartis Ringaskiddy Limited was one of the first companies in Ireland to submit an
overview of its EMS, together with an Environmental Management Programme (EMP)
based on the EMS, to the EPA in 1995. The EMS and associated EMP received the ap-
proval of the EPA in January, 1996.
The company has subsequently updated the original document on an annual basis
and has appraised the EPA of the revisions. The company also provides an annual report
on the implementation of the EMP to the Agency. All of the information referred to above
is also available to the public. The sites current EMP outlines the companys current
environmental objectives, which are supported through a system of target setting and
tracking that was introduced in 2004. The company also continues to be committed to
consolidation of the two main target areas up to the end of 2003: IPPCL Compliance;
and Resource Conservation.
7.2 The EMS in place at Novartis Ringaskiddy Limited delivers a high degree of compliance
IPPC LICENCE with the very strict conditions stipulated in the companys IPPCL issued by the EPA. The
COMPLIANCE company performs more than 230,000 readings (tests) per year to check its compliance
with its IPPC licence. Novartis Ringaskiddy Limited has set an internal target to show a
minimum compliance of 99.9 %. This means that a maximum of 120 readings out of
100,000 could be associated with non-compliances presenting the potential for an ad-
verse effect on the environment.
This internal target was achieved during 2010 when 10 non-compliant results out of
a total of more than 218,000 were notified to the EPA. The target was also achieved in
2011 when 5 non-compliant results out of a total of more than 223,000 were reported.
2012 saw a consolidation of this work when 7 non-compliant results out of a total of
more than 230,000 results were notified. It is noteworthy that the number of regulatory
environmental tests increased by approximately 8% over the three years covered by this
Environmental Statement; and by approximately 84% since 2004 (from approximately
125,000 reported results).
All the reported deviations were of a minor technical nature and did not result in any
adverse environmental effect.
7.3 The significant environmental aspects of the companys operations have been mini-
RESOURCE mised through careful design and planning.
CONSERVATION
Implementation of the companys EMS should continue to minimise their impacts. The
efficacy of the EMS in this respect will be ascertained by independent auditing. Its on-site
implementation is overseen by the site Environmental Committee, which meets formally six
times a year. Implementation of Novartis Ringaskiddy Limiteds current EMP is, therefore, to
consolidate on the progress made in the area of resource management at the facility and
this is to be effected through the setting of Process Unit and Support Unit specific targets as
outlined in the following sub-section. Novartis Ringaskiddy Limited sees two advantages in
following this approach: Further reduction in the environmental impact of operations at the
facility; and allowing greater employee input to improving environmental performance.
Tracking of progress towards meeting the 2013 environmental targets is to be undertaken

by the site Environmental Committee at its scheduled meetings. A report on the progress
towards meeting the targets specified for 2013 will be presented in the companys next
Interim Environmental Statement, which is due to be published by June of 2014.
42
Schedule of Environmental Targets for 2013 7.4

ENVIRONMENTAL
All Process and Support Units TARGETS 2013
1. All Process and Support Units. The agreed 2013 overall site hazardous waste tar-
get is set at 38.99 kg hazardous waste/kg of product shipped (which is a 6%
reduction on the 2010 figure of 41.48 kg/kg). Plan activities to meet the Novartis
Pharma 2010 to 2015 hazardous waste reduction target (Third year of five year
programme). Note that this expression of the target includes on-site solvent recov-
ery activities.
(To support the objective of reusing/recycling more of the hazardous waste that is
generated on-site (optimisation of the use of natural resources); and the objective
of striving for continual improvement in our HSE performance)
2. All Process and Support Units. The agreed 2013 overall site non-hazardous waste
target is set at 4.115 kg non-hazardous waste/kg of product shipped (which is a 6%
Pharma 2010 to 2015 non-hazardous waste reduction target (Third year of five
year programme).
43
7.4
ENVIRONMENTAL Technical Services Support Unit
TARGETS 2013
(Continued) 3. Technical Services Support Unit. Coordinate site projects and activities to meet the
agreed overall site energy target for 2013 of a 6% reduction on the relative con-
sumption of natural gas and electricity when compared to the 2008 baseline figure
of 1.4113 GJ/kg (Third year of five year programme). This gives a target of 1.3267
GJ/kg to work towards. Plan activities to meet the Novartis Pharma HSE 2015 en-
ergy optimisation target (Current five year programme).
(To support the objective of conducting our business in as sustainable a manner as

is possible; the objective of optimising the use of natural resources; and the objec-
tive of striving for continual improvement in our HSE performance)
4. Technical Services Support Unit. Coordinate site projects and activities to meet the
overall site water efficiency target of a 6% reduction on the 2012 relative water con-
sumption figure of 0.60 m3/kg. This gives a target of 0.55 m3/kg to work towards.
Plan activities to support the 2013 Novartis Pharma HSE water consumption target.

5. Technical Services Support Unit. Achieve an internal compliance rate of 99.98% (or
greater) in respect of the number of Out Of Expectation (OOE) results reported for
operation of environmental controls modules. An OOE result is one that is outside the
normal operating range but one which is still compliant with IPPCL requirements.
(To support the objective of measuring progress and verifying compliance with
National regulatory requirements)
6. Technical Services Support Unit. Install a quench and scrubbing system on the
Redundant Vapour Treatment (RVT) Module exhaust. The system should cool the
exhaust stream and remove Hydrochloric Acid (HCl), meeting Emission Point Refer-
ence Number 4s HCl Emission Limit Value while the RVT Module is on line.
(To support the objective of striving for continual improvement in our HSE perform-
ance; the objective of verifying compliance with National regulatory requirements;
and the objective of conducting our business in as sustainable a manner as is pos-
sible)
7. Technical Services Support Unit. Apply the rRCI methodology to understand the
root cause of the generation of Wastewater Treatment Plant biomass with a poor
settlement profile that can result in non-compliant readings being recorded for dis-
charges of Total Suspended Solids at Emission Point Reference Number 100 (and
the associated Chemical Oxygen Demand).
(To support the objective of striving for continual improvement in our HSE per-
formance; the objective of verifying compliance with National regulatory require-
ments; and the objective of conducting our business in as sustainable a manner as
is possible)
44
Update on Schedule of Environmental Targets for 2010 to 2012 7.5

UPDATE ON
Novartis Ringaskiddy Limited undertook a large number of projects, which shared the ENVIRONMENTAL
common theme of working towards the companys goal of continuous improvement in TARGETS 2010 to 2012
its environmental performance, over the past three years. Some of these projects were
specific to certain departments within the company; and others were company-wide.
They drew on the companys employees skills and experience to make a real difference
in helping to reduce the facilitys environmental impact. Details on the individual pro-
grammes can be found in Appendix 2.
45
8 VERIFIERS DECLARATION 9 FURTHER INFORMATION
Further to consideration of the documen- Further information regarding the contents

tation, data and information resulting from of this Environmental Statement is avail-
the organisations internal procedures ex- able from: Dr. Vincent Boyton at 00 353
amined on a sampling basis during the (0)21 4862324. Copies of the previous En-
verification process at Novartis Ringaskid- vironmental Statements of 2001 to 2003;
dy Limited, it is evident that the Environ- 2004 to 2006; and 2007 to 2009; and
mental Policy, Programme, Management the Interim Environmental Statements for
System, Review (or Audit Procedure) and 2010 and 2011 are also available.
Environmental Statement meet the re-
quirements of Regulation 1221/2009 (the Novartis Ringaskiddy Limited
EMAS Regulation) Ringaskiddy, County Cork,
Ireland
Signed:
Novartis Ringaskiddy Limited is part of the
Amanda Thorpe. pharmaceuticals division of Novartis AG.
SGS United Kingdom Limited.
Personnel
EMAS Accreditation Number: (2012): 545
UK-V-0007
Site Area: 53 ha
Rossmore Business Park,
Ellesmore Port, Industry Sector
Cheshire, (NACE Code): D21.2
CH65 3EN,
United Kingdom. Activity: Manufacture of basic
pharmaceutical products
Date: 15-Dec-2013.
Novartis Ringaskiddy Limited is engaged
The next externally verified Environmen- in the manufacture of active substances
tal Statement (covering the years 2013 to for speciality drugs used in the treatment
2015) will be issued during June of 2016. of immunologic, dermatologic, cardiovas-
The contents of this Environmental state- cular, oncological and central nervous sys-
ment will be independently validated prior tem diseases.
to publication.
46
APPENDIX 1
ENERGY SAVING INITIATIVES 2010 to 2012
The following energy saving initiatives were implemented in 2010:
In 2010, the Site Energy Management Group oversaw a number of projects that helped
mitigate the impact of manufacturing at the facility in respect of energy consumption.
These were undertaken with the goal of meeting a fixed target of an absolute reduction
of 15,000 GJ in consumption to be delivered through the implementation of specific
projects. Some of these projects included:
Upgrading the sites compressed air system
Optimising the use of cooling water
Reducing the base load energy consumption during building shutdowns
Increasing the supply temperature of cold glycol to -20 oC
Reducing the operating pressure of the refrigeration condenser
Upgrading the hot glycol pumping system
In 2011, the Site Energy Management Group oversaw a number of major projects
that helped mitigate the impact of manufacturing at the facility in respect of energy
consumption; and which when operated with the new Diovan manufacturing process
have helped to deliver significant energy savings during 2012 (and in subsequent years).
These major projects included:
Installation of a Wet Electrostatic Precipitator
The Technical Services Support Unit undertook a project that involved upgrading of
the sites liquid vapour incinerator to include what is known as a Wet Electrostatic
Precipitator (WESP). The key benefit from this project is that liquid waste streams
with a high calorific content that were being shipped off-site for third party treat-
ment can now be processed on-site using incineration with heat recovery supported
by the WESP. The project maximises the use of the existing waste incineration ca-
pacity as outlined the companys IPPCL and permission to proceed with the project
was granted by the EPA. In addition to significantly reducing the number of bulk
waste liquid shipments from the facility the project also maximises the use of the
existing heat recovery unit on the liquid vapour incinerator such that steam produc-
tion from the liquid vapour incinerator will deliver a 24% reduction in the facilitys
natural gas consumption (estimated at 1,900,000 Nm3/year).
Installation of a District Heating System
In parallel with the WESP project the Technical Services Support Unit also pro-
ceeded with a project that recovers low grade heat from the scrubber section of
the liquid vapour incinerator (using a new heat exchanger) and that distributes the
waste heat from this source to air conditioning units on-site to further reduce the
facilitys reliance on natural gas.
47
APPENDIX 1
ENERGY SAVING INITIATIVES 2010 to 2012
Installation of Heat Recovery on the Solid Waste Incinerator
The installation of the WESP also facilitated the location of a new re-heater for plume
suppression purposes on the liquid vapour incinerator. The new re-heater is of a spe-
cialised construction and a key feature is that it has a dual energy source one of which
utilises waste low grade heat from the nearby but much smaller solid waste incinerator.
The company has been exploring the possibilities for heat recovery from the solid waste
incinerator for some time; and in addition to being a good strategic fit this project has
been estimated to have a payback time of less than two years.
The Site Energy Management Group tracked the implementation of a number of en-
ergy related programmes during 2012. 2012 also saw an additional focus from Novartis
Pharma AG in respect of minimising energy usage at its various facilities worldwide,
which provided an additional impetus at site level. One of the key projects was the sub-
mission for planning permission for two 3MW wind turbines.
In summary the final project will if realised:
Generate approximately 30% of the facility's electricity supply from a renewable

source at the site (based on two 3MW wind turbines)
Further reduce Scope 2 CO2 emissions by approximately 9,700 tonnes of CO2 an-
nually (based on two 3 MW wind turbines)
Represent a strong commitment to environmental sustainability
Is in-line with an Irish government policy related to reducing carbon emissions
Bring multi-million euro investments into the site
Improve the competitiveness of each of the local operation, making it more attrac-
tive for continued operation, investment and long term employment
Provide employment during design and construction phase
The initial work in respect of preparing the planning submission commenced with the
collection of wind energy data in late 2008. Baseline ecological studies were subsequent-
ly undertaken in 2009. The project then went through feasibility and conceptual design
work; before advancing to the submission for planning permission in 2012.
In addition to this significant project the Energy Management Group also oversaw a
significant energy efficient upgrade to the (external) sight lighting; and also helped with
the optimisation of the two key projects implemented in 2011: the WESP project; and
the District Heating System project.
48
APPENDIX 2
ENVIRONMENTAL TARGETS 2010 to 2012
Year End Update on Schedule of Environmental Targets for 2010 APPENDIX 2.1
UPDATE
ON ENVIRONMENTAL
Technical Services Support Unit TARGETS 2010
1. Technical Services Support Unit. Maximise Batch Still throughput to reduce fresh
solvent consumption and the amount of hazardous waste requiring final treatment.
Contribute to achieving an overall site hazardous waste reduction target of 5%
based on the 2009 relative rate of hazardous waste generation. Note that this target
excludes solvent that is recovered on-site.
Status: Complete. A total of 23.76 kgs of hazardous waste/kg of product shipped was
generated compared to the target figure of 26.96 kgs of hazardous waste/kg of prod-
uct shipped. Solvent recovery throughput increased from 6,222 tonnes in 2009 to
7,046 tonnes in 2010, which represented a relative increase of approximately 13%.
overall site energy target of a 10% reduction on the 2006 baseline relative energy
consumption figure (equates to 2.5% for each year 2007, 2008, 2009 and 2010).

Status: Complete. Total site energy consumption was 1.43 GJ/kg of product shipped
in 2006. At the end of 2010 this figure had been reduced to 1.27 GJ/kg of product
shipped, which represents an 11% relative reduction. Relative energy consump-
tion decreased from 1.33 GJ/kg of product shipped during 2009 to 1.27 GJ/kg of
product shipped during 2010, which represents a 4% relative reduction. Note that
proportionately more saving were made in the use of electricity as the increased
solvent recovery throughput required additional use of natural gas.
3. Technical Services Support Unit. Install and commission a low flow transfer station
at the storm water retention pond to further optimise the facilitys firewater reten-
tion capacity (in line with the Environmental Liability Risk Assessment).
(To support the objective of minimising the environmental impact of our activities)
Status: Complete. The new module was installed and successfully commissioned
during the first-half of 2010. This module is used to intercept low flows of potentially
contaminated surface water and route it for wastewater treatment as a precautionary
approach, which provides for maintenance of maximum retention capacity in the
companys storm water retention pond.
4. Technical Services Support Unit. Reduce the amount of fugitive emissions of organic
carbon arising from vent disconnections and/or unavailability by 10% using the 2008
figure of 1,621 kgs as the baseline (note that the 2009 target was not achieved).

(To support the objective of minimising the environmental impact of our activities;
and the objective of striving for continual improvement in our HSE performance)
49
APPENDIX 2 (Continued)
Status: Complete. The target figure was set at 1,459 kgs and the calculated figure
for 2010 was 1,466 kgs.
5. Technical Services Support Unit. Develop an implementation plan for the possible
use of a wet electrostatic precipitator at the liquid vapour incinerator to facilitate
more on-site treatment of waste with heat recovery; and further reduce emissions
of inorganic particulate material.
Status: Complete. A complete implementation plan was produced to enable a sub-

mission to be made to the EPA at the start of January, 2011. Capital funding for the
proposed project was also secured during 2010. Full implementation of this project
will now take place during the first-half of 2011.
operation of environmental controls modules. An OOE result is one that is outside
the normal operating range but one which is still compliant with IPPCL require-
ments.
Status: Not complete. Note, however, that a total of 10 deviations required reporting
to the EPA during 2010 (out of more than 218,000 reported results) and none of
these were of environmental significance.
Production Building 2 Process Units
7. Diovan Process Unit. Maintain the rate reduction of 0.25 g/kg in the discharge
of residual amounts of Diovan from the wastewater treatment plant that was
achieved in 2007.
Status: Not complete. The 2010 discharge rate of Diovan in the treated effluent
was 0.52 g of Diovan per kg of Diovan shipped as product. A significant process
modification is to be initiated on the Diovan process at the start of 2011, which
should make a significant contribution to consistently meeting the 0.25 g/kg rela-
tive discharge rate target.
8. Ciclo/Peptides/SSF Process Unit. Eliminate the discharge of residual amounts

of Cyclosporine to the wastewater treatment plant; and minimise the discharge
of aqueous solvent to the wastewater treatment plant from washing of the A-col-
umn.
50
Status: On-going. A significant decrease in the discharge of aqueous solvent was

effected between February and November of 2009 (a decrease from 4,653 kgs
per batch (measured as Chemical Oxygen Demand) to 3,195 kgs per batch. This
was consolidated during 2010 (3,118 kgs per batch) but further optimisation and
management of this aqueous waste stream is possible. This work has freed up sig-
nificant treatment capacity in the companys wastewater treatment plant.
9. Production Building 2. Reduce the amount of fugitive emissions of organic carbon

from Production Building 2 by 10% using the 2008 discharge of 1,373 kgs as the
baseline.
Status: The calculated discharge for 2010 was 1,000 kgs when compared to the
target figure of 1,236 kgs. The overall site performance was 2,177 kgs when com-
pared to the target figure of 2,369 kgs. The latter represented an approximate 44%
relative decrease when the 2009 and 2010 data are compared.
10. Production Building 2. Reduce electricity consumption by 2.5% relative to produc-

tion (intermediates and products) to actively contribute to the site energy conserva-
tion target; and achieve an absolute reduction of 1.25 % based on the implementa-
tion of specific projects.
the objective of conducting our business in as sustainable a manner as is possible;
Status: Complete. The facilitys overall relative electricity consumption in 2010 was
0.40 GJ of electricity/kg of product shipped compared to the 2009 figure of 0.44
GJ of electricity/kg of product shipped. This represents a relative decrease of ap-
proximately 9%.
11. Production Building 2. Maintain a schedule of potential and realised improvements

in increasing the efficiency of use of raw materials (for example through the imple-
mentation of Lean and IQP projects).

tive of striving for continual improvement in our HSE performance) (To support the
objective of measuring progress and verifying compliance with National regulatory
requirements)
Status: Complete. However, more focus will be given to maintaining this schedule
during 2011 as much good work is going unrecognised.
Production Building 1 and 1A Process Units
12. Lescol/Glivec Process Unit. Maintain the residual release rate of 3.7 g of Fluvasta-
tin/kg of Fluvastatin produced in the discharge from the wastewater treatment plant.
51

Status: Not complete. The 2010 discharge rate of Fluvastatin in the treated effluent
was 4.3 g of Fluvastatin per kg of Fluvastatin shipped as product.
13. Production Buildings 1 and 1A. Stabilise the amount of fugitive emissions of or-
ganic carbon from Production Buildings 1 and 1A at the 2009 discharge level of
1,133 kgs.
Status: Complete. The calculated discharge for 2010 was 1,178 kgs when com-
pared to the target figure of 1,133 kgs. The overall site performance was 2,177
kgs when compared to the target figure of 2,369 kgs. The latter represented an
approximate 44% relative decrease when the 2009 and 2010 data are compared.
14. Production Buildings 1 and 1A. Reduce electricity consumption by 2.5% relative to
production (intermediates and products) to actively contribute to the site energy
conservation target; and achieve an absolute reduction of 1.25 % based on the
implementation of specific projects.
Status: Complete. The facilitys overall relative electricity consumption in 2010 was
0.40 GJ of electricity/kg of product shipped compared to the 2009 figure of 0.44
GJ of electricity/kg of product shipped. This represents a relative decrease of ap-
proximately 9%.
15. Production Buildings 1 and 1A. Maintain a schedule of potential and realised im-
provements in increasing the efficiency of use of raw materials (for example through
the implementation of Lean and IQP projects).

requirements)
Status: Complete. However, more focus will be given to maintaining this schedule
during 2011 as much good work is going unrecognised.
Health, Safety and Environment
16. HSE. Coordinate the implementation of the EPAs requirements in respect of the
quality of self-monitoring compliance data (as per the Agencys letter of 18-Nov-
2009).
Status: Complete
52
APPENDIX 2.2
Year End Update on Schedule of Environmental Targets for 2011 UPDATE
ON ENVIRONMENTAL
TARGETS 2011
Technical Services Support Unit
1. Technical Services Support Unit. Maximise solvent recovery throughput to reduce

fresh solvent consumption and the amount of hazardous waste requiring final
treatment. Contribute to achieving an overall site hazardous waste reduction tar-
get of 2.5% based on the 2010 relative rate of hazardous waste generation (and
plan activities to meet the Novartis Pharma 2012 hazardous waste reduction
target).
Status: Not Complete. There was a reduction in the amount of solvent that was
recovered at the facility that coincided both with the reduced output level of Dio-
van manufactured during the first-quarter of 2011 and the process improve-
ments secured from the new E1W Diovan process: A reduction from 7,046 tonnes
recovered during 2010 to 4,102 tonnes recovered during 2011, which represented
a decrease of some 14% when normalised to production. As a result of this and a
high number of product changeovers in the Multi Synthesis Process Unit during
the summer of 2011 the facilitys total amount of hazardous waste that was gener-
ated increased from a figure of 41.48 kg/kg of product shipped in 2010 to a figure
of 54.66 kg/kg of product shipped in 2011. However, the company anticipates a
significant reduction on the 2011 figure during 2012 when the new E1W Diovan
process will be operational for a full calendar year.
overall site energy target of a 2% reduction on the 2010 relative energy consump-
tion figure (and plan activities to meet the Novartis Pharma HSE 2015 energy
optimization target).

Status: Not Complete. Significant progress was made in the area energy conser-
vation over the years 2004 to 2009 with a very positive trend recorded for total
energy consumption: It decreased from 1.68 GJ/kg of drug substance shipped to
1.33 GJ/kg of drug substance shipped. This positive trend was consolidated on dur-
ing 2010 when energy consumption was 1.27 GJ/kg of drug substance shipped.
However, it was not possible to improve on this trend during 2011 with the reduc-
tion in production volumes at the facility and the delayed start-up of the new E1W
Diovan manufacturing process in the first-quarter. The corresponding figure for
2011 was 1.82 GJ of energy/kg of drug substance shipped. However, the company
anticipates a significant improvement on the 2011 figure during 2012 when the
new E1W Diovan process will be operational for a full calendar year.
overall site water efficiency target of a 3% reduction on the 2010 relative water con-
sumption figure (and plan activities to meet the Novartis Pharma HSE 2012 water
consumption target).
53

Status: Not Complete. Significant progress was made in the area of water conserva-
tion over the years 2004 to 2009. Water consumption was reduced from 1.11 m3/
kg of drug substance shipped in 2004 to 0.73 m3/kg of drug substance shipped by
the end of 2009. This positive trend was consolidated on during 2010 when water
consumption was 0.69 m3/kg of drug substance shipped. However, it was not possi-
ble to improve on this trend during 2011 with the reduction in production volumes
at the facility and the delayed start-up of the new Diovan manufacturing process
in the first-quarter. The corresponding figure for 2011 was 0.89 m3 of water/kg of
drug substance shipped. However, the company anticipates a significant improve-
ment on the 2011 figure during 2012 when the new E1W Diovan process will be
operational for a full calendar year.
4. Technical Services Support Unit. Reduce the amount of fugitive emissions of or-
ganic carbon arising from vent disconnections and/or unavailability by 2.5% using
the 2010 figure of 1,466 kgs as the baseline.
Status: Not Complete. The calculated emission for 2011 was 2,800 kgs. Note,
however, that the calculated figure is of the same order of magnitude as the figure
calculated for 2010 and the difference is not significant from an environmental
impact perspective. Note that there was a relatively high availability rate of 99.7%
for the facilitys liquid vapour incinerator during the calendar year 2011. The
liquid vapour incinerator is the main abatement system used for emissions to
atmosphere.
5. Technical Services Support Unit. Install and commission a wet electrostatic precipi-
tator at the liquid vapour incinerator to facilitate more on-site treatment of waste
with heat recovery; and further reduce emissions of inorganic particulate material.
Status: Complete. This project was successfully implemented and some more
potential improvements were identified for 2012. In addition to further reducing
emissions of inorganic particulate matter to atmosphere one of the key benefits
from this project is that liquid waste streams with a high calorific content that
were being shipped off-site for third party treatment can now be processed on-
site using incineration with heat recovery supported by the WESP. In addition to
significantly reducing the number of bulk waste liquid shipments from the facility
the project also maximises the use of the existing heat recovery unit on the liquid
vapour incinerator such that steam production from the liquid vapour incinerator
will deliver a projected 24% reduction in the facilitys natural gas consumption
(estimated at 1,900,000 Nm3/year).
6. Technical Services Support Unit. Achieve an internal compliance rate of 99.98%

(or greater) in respect of the number of OOE results reported for operation of
54
environmental controls modules. An OOE result is one that is outside the normal
operating range but one which is still compliant with IPPCL requirements.
Status: Complete. Five readings out of a total of more than 223,000 were judged to
be in non-compliance and were reported to the Environmental Protection Agency.
All non-compliances were judged to be minor deviations and did not present the
potential for having an adverse effect on the local environment.
7. Technical Services Support Unit. Install and commission a low grade heat recovery
system to utilise energy from the quench and scrubber section of the liquid vapour
incinerator in heating, ventilation and air conditioning units elsewhere on-site.

Status: Complete. This project was successfully implemented. The new system re-
covers low grade heat from the scrubber section of the liquid vapour incinerator
(using a new heat exchanger) and distributes the waste heat from this source to air
conditioning units on-site, which reduces the facilitys reliance on and consumption
of natural gas.
8. Technical Services Support Unit. Develop an implementation plan for the possible
recovery of low grade waste heat at the solid waste incinerator for use in plume
suppression in the adjacent liquid vapour incinerator.

Status: Complete. This project was successfully implemented. The installation of a

WESP on the liquid vapour incinerator also facilitated the location of a new re-heater
for plume suppression purposes on the liquid vapour incinerator. The new re-heater
is of a specialised construction and a key feature is that it has a dual energy source
one of which utilises waste low grade heat from the nearby but much smaller solid
waste incinerator. The company has been exploring the possibilities for heat recovery
from the solid waste incinerator for some time; and in addition to being a good strate-
gic fit this project has been estimated to have a payback time of less than two years.
Production Building 2 Process Units
9. Diovan Process Unit. Maintain the rate reduction of 0.25 g/kg in the discharge
of residual amounts of Diovan from the wastewater treatment plant that was
achieved in 2007. A significant process modification is to be initiated on the Dio-
van process at the start of 2011, which should make a significant contribution to
consistently meeting the 0.25 g/kg relative discharge rate target.
55
Status: Not Complete. A discharge rate of 1.53 g/kg was recorded for the year
2011. It may have been that the result quoted for 2011 was adversely affected by
the delayed start-up to the new E1W manufacturing process in the Diovan Proc-
ess Unit. The Diovan Process Unit will continue to track and where possible mini-
mise the discharge of residual Diovan to the companys wastewater treatment
plant during 2012.
10. Ciclo/Peptides/SSF Process Unit. Eliminate the discharge of residual amounts of

Cyclosporine to the wastewater treatment plant; and minimise the discharge of
aqueous solvent to the wastewater treatment plant from washing of the A-column.
Status: On-going. Significant improvements have been made to managing the

washing of the A-column, which have reduced the organic loading on the compa-
nys wastewater treatment plant. The possibility of reusing/regenerating the pack-
ing material of the A-Column is to be evaluated during 2012. The used packing
material contributed some 497 tonnes to the companys overall figure of 1,394
tonnes of non-hazardous waste generated during 2012.
11. Production Building 2. Stabilise the amount of fugitive emissions of organic carbon
from Production Buildings 2 at the 2010 discharge level of 1,000 kgs.
Status: Not Complete. The calculated amount of fugitive emissions during 2011
was 1,707 kgs. Note, however, that the calculated figure is of the same order of
magnitude as the figure calculated for 2010 and the difference is not significant
from an environmental impact perspective. The 2010 and 2011 data represent a
relatively low loss in respect of fugitive emissions from Production Building 2 and
this emission will continue to be tracked during 2012.
12. Production Building 2. Reduce electricity consumption by 2% relative to produc-

tion (intermediates and products) to actively contribute to the site energy conserva-
tion target; and achieve an absolute reduction of 1% based on the implementation
of specific projects.

Status: Not Complete. A total of 0.0560 GJ of electricity was consumed per kg of
product shipped. This building specific target was adversely affected by the delay
in introducing the new E1W process in the Diovan Process Unit during the first-
quarter. Note that the main aim of this target was to engender greater end user
awareness of patterns of energy consumption. Additional focus is to be given to this
by the facilitys Energy Management Group during 2012.
13. Production Building 2. Maintain a schedule of potential and realised improvements

in increasing the efficiency of use of raw materials (for example through the imple-
mentation of Lean and IQP projects).
56

requirements)
Status: Complete. The key project that was undertaken in Production Building 2
during 2011 was the introduction of the new E1W process in the Diovan Process
Unit. This new process is expected to deliver significant savings in respect of raw
material use (particularly the bulk solvents Ethyl Acetate and Cyclohexane) and en-
ergy consumption as two process steps have been telescoped into one. Additional
process improvement work was also undertaken on the Cyclosporine and SOM230
production trains during 2011.
Production Building 1 and 1A Process Units
14. Multi Synthesis Process Unit. Maintain the release rate of 3.7 g/kg produced of
residual Fluvastatin in the discharge from the wastewater treatment plant.
Status: Not complete. A discharge rate of 4.3 g/kg was recorded for the year 2011.
A number of improvements have been made to the equipment used in the Fluvas-
tatin production train over the past twenty-four months with a view to reducing the
discharge of residual amounts of Fluvastatin to the companys wastewater treat-
ment plant. The Multi Synthesis Process Unit also intends to make some additional
changes during 2012 and will continue to track and where possible minimise the
discharge of residual Fluvstatin to the companys wastewater treatment plant dur-
ing 2012.
15. Production Buildings 1 and 1A. Stabilise the amount of fugitive emissions of or-
ganic carbon from Production Buildings 1 and 1A at the 2010 discharge level of
1,178 kgs.
Status: Not Complete. The calculated amount of fugitive emissions during 2011
was 1,769 kgs. Note, however, that the calculated figure is of the same order of
magnitude as the figure calculated for 2010 and the difference is not significant
from an environmental impact perspective. It may be that the difference can be
account for by the large number of changes of campaigns and the introduction of
new launch products, particularly during the summer months of 2011. The 2010
and 2011 data represent a relatively low loss in respect of fugitive emissions from
Production Buildings 1 and 1A and this emission will continue to be tracked dur-
ing 2012.
16. Production Buildings 1 and 1A. Reduce electricity consumption by 2% relative to

production (intermediates and products) to actively contribute to the site energy
conservation target; and achieve an absolute reduction of 1% based on the imple-
mentation of specific projects.
57
Status: Complete A total of 0.0766 GJ of electricity was consumed per kg of prod-

uct shipped. Note that the main aim of this target was to engender greater end user
awareness of patterns of energy consumption. Additional focus is to be given to this
by the facilitys Energy Management Group during 2012.
17. Production Buildings 1 and 1A. Maintain a schedule of potential and realised im-
provements in increasing the efficiency of use of raw materials (for example through
the implementation of Lean and IQP projects).

requirements)
Status: Complete. Process improvement work was undertaken on the F12 step of
the Glivec production process during 2012. Some additional process improve-
ment work was undertaken on the Clozapine process; however, this particular prod-
uct will not be manufactured at the facility during 2012.
Health, Safety and Environment
18. HSE. Coordinate the implementation of the outcomes of the EPA site inspection of
10-Aug-2010; and the EPA site audit of 16-Nov-2010.
Status: Complete. Note that another audit was undertaken by the EPA on 04-Oct-
2011 and a schedule of corrective actions is currently being implemented.
58
Year End Update on Schedule of Environmental Targets for 2012 APPENDIX 2.3
UPDATE
ON ENVIRONMENTAL
All Process and Support Units TARGETS 2012
1. All Process and Support Units. The agreed 2012 overall site hazardous waste tar-
get is set at 47.51 kg hazardous waste/kg of product shipped (which is a 10%
Pharma 2008 to 2012 hazardous waste reduction target (Final year of five year
programme). Note that this expression of the target includes on-site solvent recov-
ery activities.
Status: Complete A total of 41.26 kg hazardous waste was generated per kg of

product shipped.
Technical Services Support Unit
agreed overall site energy target for 2012 of a 4% reduction on the relative con-
sumption of natural gas and electricity when compared to the 2008 baseline figure
of 1.4113 GJ/kg (Final year of five year programme). This gives a target of 1.3548
GJ/kg to work towards. Plan activities to meet the Novartis Pharma HSE 2015 en-
ergy optimisation target (Pending three year programme).

Status: Complete A total of 0.8439 GJ of natural gas and electricity was con-
sumed per kg of product shipped.
overall site water efficiency target of a 6% reduction on the 2010 relative water
consumption figure of 0.69 m3/kg (Final year of two year programme). This gives a
target of 0.65 m3/kg to work towards. Plan activities to meet the Novartis Pharma
HSE 2012 water consumption target, which includes preparation of a site water
balance.

Status: Complete A total of 0.59 m3 of water was used per kg of product shipped.
59
Status: Complete - Seven readings out of a total of more than 230,000 were judged
to be in non-compliance and were reported to the Environmental Protection Agen-
cy. Additional details on these seven readings can be found in the Reported Inci-
dents Summary in Section 2 of the companys Annual Environmental Report, which
is available through the EPAs website.
5. Technical Services Support Unit. Evaluate the options for installation of a quench
and scrubbing system on the Redundant Vapour Treatment (RVT) Module exhaust.
The system should cool the exhaust stream and remove Hydrochloric Acid (HCl),
meeting Emission Point Reference Number 4s HCl Emission Limit Value while the
RVT Module is on line.
ments; and the objective of conducting our business in as sustainable a manner
as is possible)
Status: Complete Two separate proposals from different vendors were under
technical and financial evaluation at year end, once of which is to be selected to go
forward for capital allocation at the beginning of 2013.
6. Technical Services Support Unit. Review and update the facilitys Surface Water
Management System taking into account the findings from the EPA Audit of Oc-
tober 2012; and the actions identified in the Surface Water Protection Rapid Root
cause Investigation (rRCI).
(To support the objective of striving for continual improvement in our HSE perform-
ance; the objective of verifying compliance with National regulatory requirements;
and the objective of conducting our business in as sustainable a manner as is pos-
sible)
Status: Complete All technical measures identified and implemented. There are
a small number of items that will be closed out during the first few weeks of 2013.
Further details are available in the Surface Water Emissions Report in Section 2 of
the companys Annual Environmental Report, which is available through the EPAs
website.
7. Technical Services Support Unit. Apply the rRCI methodology to understand the
root cause of short-term generation of Carbon Monoxide in the combustion process
of the Solid Waste Incinerator. Identify actions to minimise the potential for genera-
tion of excess Carbon Monoxide in the Solid Waste Incinerator.
as is possible)
60
Status: Complete One 10-minute OOE result was recorded between August and
December of 2012 since completion of the rRCI, which is a major improvement
on the first-half of 2012. There were no reportable deviations recorded during the
same time period.
Technical Services Support Unit and Multi Synthesis Process Unit
8. Technical Services Support Unit and Multi Synthesis Process Unit. Apply the rRCI
methodology to understand the root cause of elevated concentrations of Ammonia
in the companys treated effluent. Identify actions to minimise the potential for
discharging elevated levels of Ammonia in the treated effluent.
as is possible)
Status: Complete The root cause of the elevated concentrations was identified as
a reduced cycle time in the production batches of Darifenacin 1/2. Aqueous waste
from this process will no longer be treated in the Wastewater Treatment Plant.
61
APPENDIX 3
COMMITMENT TO BAT
Novartis Ringaskiddy Limited is fully committed to implementing the concept of Best

Available Technology (BAT) (within the framework of Integrated Pollution Prevention and
Control licensing in Ireland) at all stages in the hierarchy of:
Avoid
Reduce
Reuse/Recycle
Contain
Treatment/Disposal of Residual Material
The figures on this and the following pages are graphic representations of how the
companys environmental performance during 2010 to 2012 was better than the re-
quirements of its IPPCL issued by the EPA. This licence, inter alia, defines the minimum
performance to be expected when BAT is implemented at a site.
MASS DISCHARGES FROM WASTEWATER

TREATMENT PLANT (bright yellow column)
EXPRESSED AS A PERCENTAGE OF THE
DISCHARGE REGULATED UNDER IPPCL REGISTER
NUMBER P0006-03 (dark yellow): 2010

NUMBER P0006-03 (dark yellow): 2011

NUMBER P0006-03 (dark yellow column): 2012
Legend:
TSS: Total Suspended Solids

COD: Chemical Oxygen Demand
BOD: Biochemical Oxygen Demand
TP: Total Phosphorus
TN: Total Nitrogen
62
COMMITMENT TO BAT
MASS EMISSIONS FROM LIQUID VAPOUR

INCINERATOR (bright yellow) EXPRESSED
AS A PERCENTAGE OF THE EMISSION
REGULATED UNDER IPPCL REGISTER NUMBER
P0006-03 (dark yellow): 2010

P0006-03 (dark yellow): 2011

P0006-03 (dark yellow): 2012
Legend:
CO: Carbon Monoxide

Dust: Particulates
63
COMMITMENT TO BAT
MASS EMISSIONS FROM SOLID WASTE

INCINERATOR (bright yellow column) EXPRESSED
P0006-03 (dark yellow column): 2010


Legend:
CO: Carbon Monoxide

Dust: Particulates
64
APPENDIX 4
ENVIRONMENTAL IMPACT DATA 2010 to 2012
Novartis Ringaskiddy Limited shipped 398 tonnes of drug substances in A.4.1

2010; 270 tonnes in 2011; and 442 tonnes in 2012. This increase repre- TOTAL PRODUCTION
sents a comparable level of production at the facility when compared to the
previous three year period. The companys product portfolio for 2010 to
2012 is described in detail on page numbers 2 to 6 of this document.
Average water consumption in 2010 was 0.69 m3/kg of drug substance A.4.2
shipped; 0.93 m3/kg of drug substance shipped in 2011; and 0.59 m3/kg of WATER CONSUMPTION
drug substance shipped in 2012. This data is compared with data from the
year 2007 in the accompanying bar chart.
WATER CONSUMPTION
(m3 per kg product)
In 2010, Novartis Ringaskiddy Limited consumed a total of 504,931 Gi- A.4.3

gaJoules (GJ) of energy; in 2011 437,959 GJ; and in 2012 441,837 GJ. ENERGY CONSUMPTION
There was an on-going decrease in the companys relative energy consump-
tion when expressed as GJ per kg of product shipped: Down to 1.00 GJ/kg
of product shipped during 2012 from a figure of 1.22 GJ/kg of product
shipped during 2007. Note from the accompanying graphs for natural gas
and electricity consumption that the overall long-term trend continues to
be positive and a number of measures have been put in place for 2013 to
consolidate this positive trend.
Natural gas and electricity are the main energy types used on-site. Natural
gas is used in the two utility boilers to generate steam and also in the liquid
vapour incinerator and solid waste incinerator to ensure that adequate op-
erating temperatures are maintained. The other types of energy consumed
on-site are solvent material whose incineration incorporates heat recovery to
generate steam; and light fuel oil which is used in the facilitys own electric-
ity generator.
NATURAL GAS CONSUMPTION
(GJ per kg product)
The following two charts indicate the companys performance in relation to
consumption of electricity and natural gas during the years 2007 to 2012.
ELECTRICITY CONSUMPTION
(GJ per kg product)
65
A.4.4 Treated wastewater is discharged through the Cork County Council marine
DISCHARGES TO WATER outfall to deep water near the mouth of Cork Harbour. Discharges to water
are controlled under the companys IPPCL issued by the EPA.
The key monitoring data are summarised on the following tables. Graphi-
cal comparisons of the relative discharges of some of the key parameters
between 2007 and 2012 are also included in this section.
DISCHARGE TO WATER ANNUAL

2010 DISCHARGE
Suspended solids 8 tonnes
Biological oxygen 4 tonnes

demand (BOD)
Chemical oxygen 26 tonnes

demand (COD)
Total nitrogen < 1 tonne
Total phosphorus < 1 tonne
Data rounded to the nearest tonne

2011 DISCHARGE

demand (BOD)

demand (COD)
DISCHARGE OF COD (dark yellow column)
DISCHARGE OF BOD (bright yellow column) Total nitrogen 1 tonne
(kg per kg product)
DISCHARGE OF NITROGEN (dark yellow)

DISCHARGE OF PHOSPHORUS (bright yellow)
(kg per kg product)
66

2012 DISCHARGE

demand (BOD)

demand (COD)
Total nitrogen 1 tonne
Notes: Suspended solids are a non-hazardous by-product of biological treatment.

Discharges of such suspended solids are not significant in the context of an
estuarine environment at the mouth of a large catchment area. Consequently,
the following graphical comparisons focus on nitrogen and phosphorus dis-
charges; and BOD and COD discharges.
Nitrogen and phosphorus discharges are associated with these solids. Nitro-
gen and phosphorus can act as inappropriate fertilisers in the aquatic environ-
ment and may cause algal blooms. The figures quoted for 2010/2012 are not
significant in this context.
BOD and COD measure the potential of the discharge to result in oxygen de-
pletion in the aquatic environment. The figures quoted for 2010/2012 do not
represent a significant potential for oxygen depletion.
67
A.4.5 Emissions to air at Novartis Ringaskiddy Limited between 2010 and 2012
EMISSIONS TO AIR came from four main sources: Two utility boilers fired on natural gas, the
liquid vapour incinerator and the solid waste incinerator. The companys two
incinerators are controlled under the companys IPPCL issued by the EPA.
The emission monitoring methodology is based on European Community

and German National standards. Careful design of the facility has routed all
process-related emissions to one central treatment point. This has permitted
detailed, and in many cases continuous, monitoring of emissions to atmos-
phere from the facility.
EMISSION TO AIR ANNUAL

2010 EMISSION
Carbon dioxide 20,033 tonnes
Carbon monoxide < 1 tonne
Sulphur dioxide < 1 tonne
Nitrogen oxides 21 tonnes
Particulates < 1 tonne
Total organic carbon < 0.2 tonne

(LVI and SWI only)
Hydrochloric acid < 0.2 tonne

(LVI and SWI only)
Organic carbon 2.2 tonnes

(fugitive emissions)
LVI: Liquid Vapour Incinerator

SWI: Solid Waste Incinerator
EMISSIONS OF CARBON DIOXIDE

(kg per kg product)
68

2011 EMISSION
Particulates < 1 tonne

(LVI and SWI only)

(LVI and SWI only)

LVI: Liquid Vapour Incinerator

SWI: Solid Waste Incinerator

2012 EMISSION

FUGITIVE EMISSIONS OF ORGANIC CARBON
Particulates < 1 tonne (kg OC per kg product)

(LVI and SWI only)

(LVI and SWI only)

LVI: Liquid Vapour Incinerator EMISSIONS OF NITROGEN OXIDES

SWI: Solid Waste Incinerator (kg per kg product)
69
A.4.6 Hazardous waste generated during the years 2010 to 2012 comprised
HAZARDOUS WASTE mainly solvents, but also included smaller quantities of acids, alkalis and
other chemical wastes. Significant efforts are underway to reuse/recycle as
much of this material as possible. For example, additional solvent recovery
capacity has been installed at the facility to increase the amount of rectified
solvent that can be reused by the production buildings. The company is also
recovering solvent material off-site that was here-to-fore being incinerated.
HAZARDOUS WASTE 2010
Total hazardous waste 16,496 tonnes

generated
Total recycled/reused 14,721 tonnes
On-site incineration with heat recovery 1,736 tonnes
On-site solvent recovery (see foot note) 7,046 tonnes
Off-site incineration with heat recovery 5,529 tonnes
Off-site solvent recovery 357 tonnes
Other waste for off-site recovery 53 tonnes
Total treated 1,775 tonnes
On-site incineration without heat recovery 338 tonnes
On-site wastewater treatment 336 tonnes
Off-site incineration 1,102 tonnes

(primarily incineration without heat recovery)
Note: Solvents are recycled many times within the production buildings. Following
such reuse the solvents are transferred to the solvent recovery unit. The figure
quoted in the table for recycling refers only to recycling of solvents in the facili-
tys solvent recovery unit, together with a smaller amount of solvent material
that was recycled off-site.
70
Total hazardous waste generated 14,772 tonnes
Off-site solvent recovery 524 tonnes
Off-site treatment 471 tonnes

(primarily incinerationwithout heat recovery)
Total hazardous waste generated 18,230 tonnes

TOTAL HAZARDOUS WASTE GENERATED
Off-site solvent recovery 317 tonnes (kg per kg product)
Off-site treatment (primarily incineration 1,196 tonnes

(without heat recovery)
HAZARDOUS WASTE REUSED/RECYCLED
Data rounded to the nearest tonne (kg per kg product)
71
A.4.7 Non-hazardous waste generated during the years 2010 to 2012 at Novartis
NON-HAZARDOUS WASTE Ringaskiddy Limited included office, cafeteria, non-contaminated glass, met-
al and inert absorbent wastes, wastewater treatment plant sludge and bio-
degradable and compostable waste. A significant quantity of these materials
was sent off-site for recycling. Inert absorbent wastes, wastewater treatment
plant sludge and biodegradable and compostable data are based on weigh-
bridge readings, while data for office, cafeteria, non-contaminated glass and
metal waste are now also based on weigh-bridge readings.
NON-HAZARDOUS WASTE 2010
Non-hazardous waste generated 1,741 tonnes
Total recycled 1,627 tonnes
Total disposed 101 tonnes
Total treated 14 tonnes

TOTAL NON-HAZARDOUS WASTE GENERATED
(kg per kg product)
NON-HAZARDOUS WASTE RECYCLED/REUSED Data rounded to the nearest tonne

(kg per kg product)

NON-HAZARDOUS WASTE TREATED/DISPOSED
(kg per kg product) Data rounded to the nearest tonne
72
Sound levels at the boundary of the facility have remained in compliance with the terms A.4.8
of the companys IPPCL and the relevant EPA Guidelines over the years 2010 to 2012. NOISE
This is based on the results of annual sound level monitoring that have been submitted
to the Agency.
The company has discontinued monitoring of ambient air in the vicinity of the facility A.4.9
as there have been a number of other industrial developments in vicinity of Novartis AMBIENT AIR QUALITY
Ringaskiddy Limited over the past number of years. In its place the company actively
contributes to the local animal health surveillance scheme that is run by the Veterinary
Department of the Local Authority on behalf of the EPA. This scheme, which has been
running since 1993, has not identified any animal health issues in the Cork area that
can be associated with industrial activity. The most recent report was issued during De-
cember 2005 and covers the years 2001 to 2004 and is available from the Agency. It
is anticipated that a report covering the years 2005 to 2010 will be issued by the Local
Authority in 2013.
The quality of the groundwater beneath the 53 hectare site at Novartis Ringaskiddy A.4.10
Limited has remained the same as that prior to the commencement of operations at the GROUNDWATER
facility. Groundwater is sampled twice a year from four on-site monitoring wells and is AND SURFACE
subject to detailed analysis. These data are compared with the data on the quality of the WATER QUALITY
groundwater that was established prior to the commencement of manufacturing activi-
ties on-site.
There are limited groundwater reserves on-site and the groundwater in the local area,
which is a small peninsula in Cork Harbour, is subject to saline intrusion. Consequently,
it tends not to be used as a supply of potable water.
All surface water, mainly rainfall falling on paved areas, was analysed prior to leaving
the facility to ensure that it was not contaminated. Surface water was routed by a gravity
fed pipeline to one of two compartments of a large storm water retention pond. Here
the water was continuously analysed to confirm its suitability for discharge. If necessary
the water was automatically quarantined; and subsequently manually sampled and ana-
lysed to ensure suitability for discharge from the site. If surface water was quarantined in
one compartment then the other compartment was available for operational use.
A number of significant upgrades have been made at the facility over the past number
of years to improve both surface water and groundwater protection. Additional contain-
ment around the process lift station and the neutralisation basin in the wastewater treat-
ment plant was installed as a further safeguard to prevent any inadvertent contamination
of soil or groundwater. The capacity of the storm water retention pond was increased
from approximately 5,000 m3 to 10,000 m3; and a new low flow transfer station was
also installed on the inflow to the storm water retention pond to intercept potential low
volume spillages so that maximum retention capacity is maintained at the storm water
retention pond.
Additional improvements in respect of surface water and ground water protection were
evaluated during 2012 and these include optimising the retention volumes in the facili-
tys two remote bunds (the Spill Basins) together with improving the existing bunding
arrangements at Warehouse 6. A more comprehensive closed circuit television inspec-
tion of the surface water draining system beneath the facility was also undertaken for the
first time during 2012; together with the implementation of an annual cleaning of both
compartments of the companys storm water retention pond.
73
APPENDIX 5
RESOURCE CONSERVATION 2007 to 2012
The company is continuing to seek to make environmental progress by effecting a rela-

tive reduction in the consumption of:
Natural gas;
Electricity; and
Water;
effecting relative reductions in the amounts of:
Hazardous waste (primarily liquid waste for incineration) requiring treatment;
Non-hazardous waste requiring final disposal and treatment; and
Fugitive emissions to the atmosphere;
and rectifying more solvent for reuse via the companys solvent recovery facility.
A graphical representation of the company's performance in respect of these param-

eters from 2007 to 2012 is presented in this appendix.
Inputs in the assessments are expressed per kilogramme of final product manufac-
tured. Note that savings in water, natural gas and electricity consumption should lead
to reduced wastewater discharge volumes to be treated and to reduced emissions (less
running time of boilers and utility plants).
The 2007 to 2012 figures in the following graphs are based on actual data. Data on
water, natural gas and electricity consumption are based on meter readings; data on
fugitive emissions are based on regular measurements; while the data on hazardous and
non-hazardous waste and rectified solvent are based on the company's measurements
and/or records. All data have been made publicly available.
74
A.5.1
NATURAL GAS CONSUMPTION
Natural gas consumption is expressed as

GJ consumed per kilogramme of product
manufactured.
A.5.2
ELECTRICITY CONSUMPTION
Electricity consumption is expressed as

GJ consumed per kilogramme of product
manufactured.
A.5.3
WATER CONSUMPTION
Water consumption is expressed as m3

consumed per kilogramme of product
manufactured.
A.5.4
FUGITIVE EMISSIONS
Fugitive emissions are expressed as kilo-

gramme of organic carbon per kilogramme
of product manufactured.
A.5.5
TOTAL HAZARDOUS WASTE
GENERATED
Total hazardous waste generated is expressed

as kilogramme generated per kilogramme of
product manufactured.
75
A.5.6
NON-HAZARDOUS WASTE
TO BE TREATED/DISPOSED
Non-hazardous waste to be treated/dis-

posed of is expressed as kilogramme per
kilogramme of product manufactured.
A.5.7
SOLVENT TO BE RECTIFIED
Solvent to be rectified of is expressed as

kilogramme of rectified solvent per kilo-
gramme of product manufactured.
76
APPENDIX 6
ASSESSMENT OF SIGNIFICANCE OF ENVIRONMENTAL ASPECTS
Section 3 of Annex I of the EMAS Regulation states that it is a requirement of participants

to define the criteria for assessing the significance of the environmental aspects of its
activities, products and services, to identify those that have a significant environmental
impact. The criteria for determining significance need to be comprehensive, capable of
independent checking and made publicly available.
Novartis Ringaskiddy Limiteds methodology for assessing the significance of its direct
and indirect environmental aspects has been developed in collaboration with RPS Group
Limited and the following is an extract from the companys most recent review of its
direct and indirect environmental aspects, which was undertaken in collaboration with
RPS Group Limited.
The criteria used to assess the significance of each identified direct and indirect envi-
ronmental aspect were:
Legislative compliance
Resource depletion
Potential impact on air, water and land
Stakeholder interest
The significance of each aspect was assessed using a matrix to rank its significance
refer to Table A.6.1 below. The matrix allowed each aspect to be scored using the relevant
criteria. Each criterion was assigned a weighting factor to reflect its importance. The envi-
ronmental impact and resource depletion criteria had been considered more important
than legislation/regulation and stakeholder interest criteria and were originally assigned
a weighting factor of 3. However, on reflection in the 2012 review, the scoring system
was amended to increase the weighting factor for legislation/regulation from 2 to 3 com-
mensurate with the importance of this criterion. In this regard, where an aspect is subject
to IPPC compliance and/or other regulation, by default it is considered significant. This
does not suggest that the impact is significant, merely the aspect. The score from each
criterion is multiplied by the relevant weighting factor and then all criteria scores are
summed to give a total score for the aspect under normal operating conditions.
Reference:
Aspect:
Impact:
Score Weighting
Criteria Score
3 2 1 0 Factor
Legislation/
Existing Impending None 3
Regulation
Resource
High Medium Low None 3
depletion
Environmental
impact
Stakeholder
interest
Maximum possible score= 33, significant aspect score 16
Table A.6.1 Matrix for assessing the significance of a direct or indirect environmental aspect under normal
operating conditions
77
APPENDIX 6
ASSESSMENT OF SIGNIFICANCE OF ENVIRONMENTAL ASPECTS (Continued)
The EMAS Regulation also requires that each aspect be assessed taking other operating
conditions such as accident, previous, planned and abnormal conditions, into account.
Assessment of the identified environmental aspects under other conditions was under-
taken using Table A.6.2 below.
Reference:
Aspect:
Impact:
Score Score
Criteria
12 6 3 0
Increased Reduced
Abnormal
environmental No change environmental
operations
impact impact
Increased Reduced
Accident/
environmental No change environmental
emergency
impact impact
Evident/ Possible
Past
requires damage/difficult - No damage
activities
action to evaluate
Increased Reduced
Planned
- environmental No change environmental
activities
impact impact
Maximum possible score= 30, significant aspect score 15
Table A.6.2 Matrix for assessing the significance of a direct or indirect environmental aspect under other
conditions
The scores for normal operating and other conditions were assessed and a signifi-
cance threshold set for each direct or indirect environmental aspect. The threshold was
set at 50% of the maximum possible score (>15) for both normal operating conditions
and other conditions. This threshold level allowed the significant aspects to be identi-
fied and included in the companys register of significant environmental aspects and the
insignificant aspects scoped out.
Further information on the application of the methodology is available on request.
78
APPENDIX 7
EMAS CORE INDICATORS 2010 to 2012
A. 7.1 EMAS CORE INDICATORS 2010 AIR EMISSIONS
GENERAL FIGURES Sulphur dioxide: < 1 tonne
Total HSE Investments: 9,115,841 Nitrogen oxides: 21 tonnes
Investments for Environmental Protection: 5,702,600 Particulates: < 1 tonne
Total HSE Costs: 11,475,354 Carbon dioxide: 20,033 tonnes
Costs for Environmental Protection: 9,666,670 Carbon monoxide: < 1 tonne
Total HSE Personnel: 27 Hydrochloric acid: < 0.2 tonne

(LVI and SWI only)
Environmental Protection Personnel: 20
Total organic carbon: < 0.2 tonne
Total Personnel: 430 (LVI and SWI only)
Total Production: 397.684 tonnes Organic carbon: 2.2 tonnes

Site Area: 53 ha
Built Area: 35 ha
Amenity Area: 18 ha WASTE
Total Non-Hazardous Waste 1,741 tonnes

CONSUMPTION OF RESOURCES
Recycled: 1,627 tonnes
Total water consumption: 272,907 m3
Treated: 14 tonnes
Total energy consumption: 504,931
GigaJoules Disposed of: 101 tonnes
Renewable energy 39 Total Hazardous Waste: 16,496 tonnes

(On-site solar panels) GigaJoules
Recycled/reused: 14,721 tonnes
Fresh solvent consumption: 7,453 tonnes
On-site incineration with heat recovery: 1,736 tonnes
WATER DISCHARGES On-site solvent recovery: 7,046 tonnes
Total treated effluent discharged: 548 m3/day Off-site incineration with heat recovery: 5,529 tonnes
Suspended solids: 8 tonnes Off-site solvent recovery: 357 tonnes
Biochemical oxygen demand: 4 tonnes Other waste for off-site recovery: 53 tonnes
Chemical oxygen demand: 26 tonnes Treated: 1,775 tonnes
Total nitrogen: < 1 tonne On-site incineration without heat recovery: 338 tonnes
Total phosphorus: < 1 tonne On-site wastewater treatment: 336 tonnes
Data rounded to the nearest tonne Off-site treatment (primarily incineration 1,102 tonnes
without heat recovery):
79
APPENDIX 7
EMAS CORE INDICATORS 2010 to 2012 (Continued)
Investments for Environmental Protection: 665,850 Particulates: < 1 tonne
Total HSE Costs: 11,949,182 Carbon dioxide: 17,120 tonnes

(LVI and SWI only)

Site Area: 53 ha
Built Area: 35 ha
Total Non-Hazardous Waste: 1,472 tonnes

Treated: 12 tonnes

Total nitrogen: 1.4 tonnes On-site incineration without heat recovery: 522 tonnes
Data rounded to the nearest tonne Off-site treatment (primarily incineration 471 tonnes
without heat recovery):
80
APPENDIX 7
EMAS CORE INDICATORS 2010 to 2012 (Continued)
Investments for Environmental Protection: 3,370,630 Particulates: < 1 tonne
Total HSE Costs: 14,950,104 Carbon dioxide: 18.622 tonnes

(LVI and SWI only)

Site Area: 53 ha
Built Area: 35 ha

Treated: 11 tonnes

Total nitrogen: 1 tonne On-site incineration without heat recovery: 495 tonnes
Data rounded to the nearest tonne Off-site treatment (primarily incineration 1,196 tonnes
(without heat recovery):
81
www.ie.novartis.com
4.0 MANAGEMENT OF THE ACTIVITY
This section updates section 4.0 and associated sub-sections of the facility's original EMP (dated 16-Nov-
1995); the first revision to that EMP (dated 21-Nov-1996); the second revision (dated 21-Nov-1999); the
third revision (dated 07-Dec-1998); the fourth revision (dated 15-Dec-1999); the fifth revision (dated 01-
Feb-2001); the sixth revision (dated 01-Feb-2002); the seventh revision (dated 31-Mar-2003); the eight
revision (dated 01-Apr-2004); the ninth revision (dated 01-Apr-2005); the tenth revision (dated 01-Apr-
2006); the eleventh revision (dated 01-Apr-2007); the twelfth revision (dated 01-Apr-2008); the thirteenth
revision (dated 01-Apr-2009); the fourteenth revision (dated 01-Apr-2010); the fifteenth revision (dated
01-Apr-2011); the sixteenth revision (dated 01-Apr-2012); and the seventeenth revision (dated 01-Apr-
2013). Cross-reference is made to the original document in the first instance and then to the subsequent
revisions, where there have been no significant changes. The various sub-sections of this document
retain the same headings and numbering systems as the preceding documents.
The various revisions are referred to in section 4.0 as follows:

____________________________________________________________________________________
Version Date Covering the Year Referred to as

____________________________________________________________________________________
Original 16-Nov-1995 1996 Rev 0
First Revision 21-Nov-1996 1997 Rev 1
Second Revision 21-Nov-1997 1998 Rev 2
Third revision 07-Dec-1998 1999 Rev 3
Fourth Revision 15-Dec-1999 2000 Rev 4
Fifth Revision 01-Feb-2001 2001 Rev 5
Sixth Revision 01-Feb-2002 2002 Rev 6
Seventh Revision 31-Mar-2003 2003 Rev 7
Eight Revision 31-Mar-2004 2004 Rev 8
Ninth Revision 01-Apr-2005 2005 Rev 9
Tenth Revision 01-Apr-2006 2006 Rev 10
Eleventh Revision 01-Apr-2007 2007 Rev 11
Twelfth Revision 01-Apr-2008 2008 Rev 12
Thirteenth Revision 01-Apr-2009 2009- Rev 13
Fourteenth Revision 01-Apr-2010 2010 Rev 14
Fifteenth Revision 01-Apr-2011 2011 Rev 15
Sixteenth Revision 01-Apr-2012 2012 Rev 16
11
Seventeenth Revision 01-Apr-2013 2013 Rev 17
Eighteenth Revision 01-Apr-2014 2014 Rev 18

____________________________________________________________________________________
4.1 Process Modifications Resulting in Improved Yields, Elimination or Reduction of

Wastes or the Use of Alternative Less Hazardous Materials
Please refer to the corresponding sub-section of Rev 0 and subsequent revisions Revs 1 to 16.
A number of significant process modifications were made on the Diovan, Glivec, Cyclosporine,
QAB149 and Darifenacin processes. over the course of Revs 15 and 16.
A number of process modifications were also undertaken on the Diovan, Cyclosporine and Octreotide
SPPS processes during the course of Rev 17 with the goal of improving yield, reducing the requirement
for raw materials, reducing waste and minimising energy consumption, however, these were of a
somewhat smaller scale than some of the projects that were run over the past number of years.
The Cyclosporine project centred around product offload weighing and recording. It was designed to
simplify the workflow so that the use of pre-SAP labels was eliminated; transcription errors to the batch
records and SAP were minimised; movements to and from the Cyclosporine Offload Room for label
collection were significantly reduced; there is no future need to make a final gross weight check versus
the batch record; and there is no further requirement to re-open drums to apply SAP labels to liners.
The Octreotide project centred on improving the yield per batch of the SPC step in the process from 1.87
kgs to 2.0 kgs (Octreotide itself is a low volume, high value product). All Process parameters that may
introduce variability in the yield output were examined: Flowrates, pressures, times on HPLC columns,
alarms etc. In parallel with the process a review of the SPC step cycle time was also be undertaken. An
additional Octreotide optimisation project focused on the optimisation of the evaporator performance in
the SPPS step in the process. The goal of this work was to minimise the formation of thiols and dimers in
the process, which can result in a batch not meeting quality control requirements and the requirement to
rework batches and/or dispose of batches.
Additional optimisation work was also undertaken on the Diovan, process, which focused on the use of
the NIR instrumentation that was installed in recent years. The work was aimed at securing additional
energy savings by using on-line instrumentation to identify when the drying cycle has reached the end
point.
12
4.1.1 Site Waste Management Group
Please refer to the corresponding sub-section of Rev 4.
4.1.2 Electronic Waste Tracking System
Please refer to the corresponding sub-section of Revs 3 and 4.
It was proposed to introduce a new electronic tracking system (the Waste Tracking System (WTS) for
solid waste destined for the site's Solid Waste Incinerator during 2002 as part of the sixth revision to the
EMP. The aim of the WTS was to replace the then existing paper based system and to incorporate the
provisions of Schedule 3 (ii) of IPCL Register Number 545. During the course of 2002 it became clear
that the proposed WTS could also be used to track other wastes on site and consequently, the roll-out of
the WTS was deferred until 2003. Tracking stations were installed throughout the site and the software
application to support the WTS was rolled out to a number of key workstations. The WTS went live during
the first third of 2003 (as anticipated in Rev 7). During the last nine months of 2003 the WTS was used
for the tracking of solid waste that was incinerated in the facilitys Solid Waste Incinerator. From 2004 the
WTS started to be used for tracking consignments of waste shipped off-site for treatment (as anticipated
in Rev 8).
During 2005 the WTS was integrated successfully with a new weigh bridge (refer to section 4.1.5) that
was installed at the facility. This permits the accurate weighing of each load of waste material leaving the
site and allows for an accurate reconciliation to be made between the site recorded weight and the weight
that is returned to the site on the certificate of treatment/disposal in the case of hazardous waste).
The use of the WTS was further rolled out between 2006 and 2008 to include practically all non-
hazardous waste shipments leaving the facility. The company also moved to making the WTS to be the
reporting tool of choice to meet the requirements of Condition 11.10 of IPPCL Register Number P0006-
03 (to be backed up with the relevant paper based documentation) during 2008. Of especial note during
2008 was the full integration of the projects department into the WTS, which ensures that all waste
arising from project type activities items such as construction and demolition waste, waste metal from
pipework modifications etc are now tracked electronically rather than using a paper based tracking
system.
Capital of the order of 100,000 was committed to this project (over the years 2003 to 2007); and an
additional tranche of funding of the order of 75,000 was committed to fully update the waste tracking
system during 2008.
To compliment this work a more focused segregation at source of solid hazardous waste was rolled out
across the facility during the course of 2009. This work involved retraining all personnel whose work
involves packing and labelling of hazardous waste in the new segregation system and its interface with
the WTS. All access to the WTS was disabled until successful completion of the training. The purpose of
the new segregation system is to better separate the solid hazardous waste fractions arising at the facility
so as to better optimise waste management and treatment. Additional re-fresher training in respect of
source segregation and use of the WTS was carried out throughout 2011 and 2012.
13
A major new revision to the Waste Tracking System software was rolled out in mid-2012. The new
revision builds on the companys experience of using the older version and includes many new features.
The cost of this upgrade was of the order of 100,000.
4.1.3 Off-site Reuse of Inert Adsorbent
Please refer to the corresponding sub-section of Revs 6 to 8; and Rev 10.
4.1.4 Biodegradable Sludge Management
Please refer to the corresponding sub-section of Revs 6 to 9; and Rev 11.
The company proposed to use the ERAS ECO Limited (previously AVR Environmental Solutions Limited)
facility in Foxhole, Youghal, County Cork (EPA Waste Permit Number W0211-01) to dry the companys
non-hazardous sludge prior to subsequent treatment as part of the twelfth revision to the EMP (in addition
to the other waste management facilities already used).
One of the reasons for starting to utilise this waste management contractor is that there was no change in
the relative amount of non-hazardous waste to be disposed between 2006 and 2007 a figure of 0.0028
tonne/kg of product shipped was recorded for both years. The main reason for this was that practically all
of the non-hazardous wastewater treatment plant sludge shipped from the facility during 2006 and 2007
was under a D code. This changed to an R code during 2008 as a result of using the ERAS ECO
Limited facility, which helped maintain the progress towards maximising reuse and recycling of non-
hazardous waste arising at the facility. During 2009, 2010, 2011, 2012 and 2013 all sludge arising from
wastewater treatment plant operations was shipped to the Youghal Facility under an R1 code and
comprising of some 977 tonnes, 829, 482, 684 and 745 tonnes for the respective years.
The other key reason for using this outlet was that it maintained the companys approach of incinerating
the sludge arising from wastewater treatment to ensure that any residual drug substances were treated in
a way that ensured full destruction. The ERAS ECO Limited facility provided an economic way of doing
this by drying the sludge locally prior to onward shipment to a thermal treatment facility in Europe. At this
point in time the company is actively working to reopen its original route to a licensed thermal treatment
facility for sludge that has not been dried beforehand. The need to do this has arisen because of the
current permit status of the ERAS ECO Limited facility. A number of facilities in Europe have been
identified and work is underway to put a Transfrontier Shipment Notification in place; together with some
local engineering modifications that will need to be made to allow for suitable packing of this waste for
onward shipment.
4.1.5 Installation of Weigh Bridge
Please refer to the corresponding sub-section of Rev 9; and Rev 11.
14
4.1.6 Diversion of Spent Lime and Activated Carbon to Beneficial Reuse
Please refer to the corresponding sub-sections of Rev 9 and Rev 10.
The following outlets are currently used by the company to treat the mixture of spent lime and activated
carbon that arises as part of the flue gas cleaning system on the companys Solid Waste Incinerator
(Emission Point Reference Number 3).
Description of Hazardous Waste D/R Location of Name of Waste Disposal Licence/Perm

EWC Code Waste Tag Code Disposal/Recovery Recovery Contractor it Reference
(c) Veolia Es Onyx

Limited. Charleston Veolia Environmental
41 Hazardous Road, Hardley, Services Technical
Flyash containing Thermal Southampton SO45 Solutions Limited, Corrin, EPA Waste
dangerous Treatment 3NX., United Fermoy, County Cork, Licence
19 01 03 substances Residues D10 Kingdom Ireland W0050-02
41 Hazardous (c) Revatech S.A., Services Technical
Flyash containing Thermal Zoning Industriel Solutions Limited, Corrin, EPA Waste
dangerous Treatment D'Ehein, B-4480, Fermoy, County Cork, Licence
19 01 03 substances Residues R4 Belgium Ireland W0050-02
To facilitate this proposal a number of small physical modifications were proposed as part of the ninth
revision to the EMP. These have since been implemented and include:
1. Replacement of the existing rotary valve at the off-load station with a smaller unit to increase the
available height under the discharge point, which allows an FIBC big bag to be fitted.
2. An ILC Dover attachment has been fitted to the new rotary valve. This allows the FIBC big bag to
be connected/disconnected in a contained manner and avoid local dusting. The stub end contains
any spent lime and activated carbon that gets caught up in the discharge from the rotary valve.
3. There has been a change from the smaller plastic bags that were previously used to FIBC big
bags.
This work also included removal of redundant equipment around the discharge station, upgrading of local
lighting and cleaning down the area. Some further small modifications were implemented during the
course of Rev 11 to facilitate ease of movement of the packed spent lime and activated carbon. These
will be complimented by some improvements in respect of containment during off-loading, which were
completed during the course of the twelfth revision to the EMP.
As noted in sub-sections 4.1.3 and 4.1.4 the company has made significant progress in recent years to
recycle and reuse specific waste streams that were previously landfilled. Implementation of this project
has resulted in a reduction in the amount of non-hazardous waste going to landfill in that the lime
component of the spent lime and activated carbon was previously landfilled as part of a mixture of bottom
ash and slag (once the carbon component had been incinerated).
15
4.1.7 New Segregation System for Non-Hazardous Waste
During the course of 2005 Novartis Ringaskiddy Limited rolled out an improved segregation system at the
facility for solid non-hazardous waste (not including wastewater treatment plant sludge or used inert
adsorbent) with the objective of diverting more material from landfill to reuse/recycling. Following a review
the company focused on what might be called the residual non-hazardous waste that is generated at the
facility, items such as paper, cardboard, plastic and glass. Some of these were already being recycled
but the review indicated that with better on-site organisation that the amounts of these materials that
could be reused and recycled could be increased quite dramatically.
During late 2004 a dedicated sorting and packing facility was built on site as part of the preparation for a
major drive to start segregating this waste for reuse and recycling. This new facility is manned five days a
week and from 2005 onwards commenced a support service for all of the major areas on site in respect
of paper, cardboard, plastic and glass. A significant part of the process was to engage the companys
employees directly in the process and this took place throughout 2005 as the new system was rolled out.
Local segregation of these types of waste has now become the norm for all areas. During the course of
the tenth and eleventh revisions to the EMP the work focused in consolidating the implementation of at
source segregation; optimisation of metal recycling; and to track the amounts of non-hazardous waste
that are being generated using the companys new weighbridge (refer to sub-sections 4.1.2 and 4.1.5).
As noted in sub-section 4.1.2 of especial note during the course of Rev 13 was the full integration of the
projects department into the WTS, which ensures that all waste arising from project type activities items
such as construction and demolition waste, waste metal from pipework modifications etc are now
tracked electronically rather than using a paper based tracking system.
A new dedicated segregation area for non-hazardous waste generated by the projects department was
installed at the west side of the facility during early 2012. This has dedicated parking bays for skips to
remove items such as wood, metal and construction and demolition waste from the facility. The area has
been given a finished surface to provide for additional soil and groundwater protection and suitable
drainage to the facilitys (controlled) surface water system.
4.1.8 New Source Segregation of Biodegradable/Compostable Waste
One of the new developments in the management of non-hazardous waste at the facility during 2010 was
the segregation of biodegradable and compostable waste primarily waste foodstuff. This waste stream
was previously landfilled. A total of approximately five tonnes of such waste was sent for composting
during 2010 and the larger amount of approximately ten tonnes was sent during 2011. To consolidate on
this work the scheme was extended during 2012 to the facilitys satellite break areas; and a customer
segregation system was also introduced in the main cafeteria. This has helped to maximise the amount
of such material being diverted from landfill to composting. A total of approximately 14 tonnes was sent
for composting during 2012; and this figure increased to approximately 17 tonnes during 2013 as the use
of the segregation scheme was consolidated.
16
4.1.9 Reclassification of Bottom Ash and Slag
Following a request from the Agency the company undertook a classification of the bottom ash and slag
that arises at the facilitys Solid Waste Incinerator using the Agencys hazardous waste classification tool.
Following a detailed sampling and analytical programme it was found that the amount of Zinc Oxide in the
bottom ash and slag rendered the waste stream hazardous. The Zinc Oxide arises when galvanised base
plates and metal clamps and bands from packaging waste is incinerated. The company is investigating
ways in which this galvanised material might be routed away from solid incineration on-site. In the interim
this waste stream is now shipped from the facility as a hazardous waste under the European Waste
Catalogue (EWC) code 19 01 11* to EMV Germany, at EMV the material is pre-treated, stabilised and
mixed with other waste streams and then sent to TRV (under 19 02 04*) for incineration. Details of both
facilities are outlined below:
EMV: (D13)
Entsorgungsgesellschaft mbH
fur Mecklenburg - Vorpommern
Admannshager Damm 18
18211 Bargeshagen
Licence No: M51ZL-016
TRV: (D10)
Thermische Rckstandsverwertung GmbH & Co. KG
Rodenkirchener Strae
50389 Wesseling
Licence No: E36232112
4.2 Improved Process Control (Equipment and Management) to Reduce Waste
Please refer to the corresponding sub-section of Rev 0 and Revs 6 and 7.
4.2.1 Automation in Process Control
4.2.2 Sequence of Use of Automation in Production
4.3 Improvements in Equipment Cleaning Procedures Resulting in Reduced Materials

Usage or Alternative Materials Usage
Please refer to the corresponding sub-section of Rev 0; Rev 2; and Rev 4.
17
4.4 Maintenance and Calibration of Key Control and Monitoring Equipment
It was proposed in Rev 10 to the EMP that environmentally critical instrumentation and equipment would
have a dedicated field on the companys Computerised Maintenance Management System (CMMS) to
enable more transparent data searches. This work was successfully during the course of 2006 and is
now fully functioning.
The company migrated from its existing CMMS called Maximo to a new SAP based CMMS in the second-
half of 2013. This was a major project that was undertaken for the scheduled maintenance and calibration
of all key equipment on-site; and full training was rolled out across all Process and Support Units on-site
to ensure continuity of maintenance and calibration of key (environmental) control and monitoring
equipment. All environmental preventative maintenance activities and calibrations have been created with
a type ZIE01PM2 on the new SAP based CMMS to distinguish them and allow easy traceability.
The migration of the CMMS at Novartis Ringaskiddy Limited to SAP formed part of the global roll-out of
SAP as the platform for maintenance management at Novartis globally. In this respect it forms one of the
pillars of the Novartis integrated Engineering, along with COMOS and eCalibration.
4.4.1 Maintenance and Calibration of Key Atmospheric Emissions

Note that all maintenance work complies with Condition 2.2.2.9 of IEL Register Number P0006-03.
4.4.2 Maintenance and Calibration of Key Atmospheric Emissions

Please refer to the corresponding sub-sections of Revs 0 to 9.
Novartis Ringaskiddy Limited, in addition to its own internal calibration programme for both sets of
Continuous Emission Monitors (CEMs) (for the Liquid Vapour Incinerator and the Solid Waste
Incinerator), now has annual independent verification of their performance undertaken as an additional
safeguard to ensure that emissions are accurately monitored and quantified. All maintenance work is
undertaken and complies (in particular) with Conditions 2.2.2.9 and 4.1.1. (iii) of IEL Register Number
P0006-03.
It was proposed to install new monitoring software for the CEMs during the course of the eleventh
revision to the EMP. The software was to be fully compliant both with the requirements of IEL Register
Number P0006-03; and the Incineration of Waste Directive 2000/76/EC. The software was only validated
18
to the required standard by the sole European supplier during the first-half of 2007; and was installed on-
site during the second-half of 2007.
The existing on-line particulate analysers for both the Liquid Vapour Incinerator and the Solid Waste
Incinerator were replaced towards the end of the twelfth revision to the EMP and at the start of the
thirteenth. Both units had been in use for over ten years and were at the end of their working lives. The
new monitoring system continues to meet the requirements of IEL Register Number P0006-03; and the
Incineration of Waste Directive 2000/76/EC. A capital allocation of the order of 130,000 was made to
effect the replacement together with upgrading of the associated sampling system.
Both analysers underwent QAL-2 testing as part of the installation work and commissioning; and the
QAL-2 testing was extended to the all of the remaining on-line analysers monitoring the emissions from
the Liquid Vapour Incinerator and the Solid Waste Incinerator at the beginning of 2009. This work took
slightly longer than was originally anticipated and following the outcome of stratification testing some new
sampling points were installed to facilitate optimal sampling of all pollutants requiring on-line monitoring.
The complete body of work was only finalised during later 2009/2011 and a report is available for
inspection by the Agency of the full QAL-2 testing programme and outcome.
During 2013 the software on the CEMs computers was updated to ensure compliance with the EPA
guidance on the Waste Incineration Directive (WID) CEM confidence Intervals that was issued in late
2012. Correction factors that are generated during the QAL-2 testing that compare the site CEMs to a
reference test analyser, were inputted to the CEMs computers and applied in a specific manner. This
work required re-programming the software of these computers to accept these new correction factors.
4.4.3 Maintenance and Calibration of Key Sewer Emissions

4.4.4 Maintenance and Calibration of Key Sewer Emissions

4.5 Improvements in Treatment/Abatement Systems to Reduce Emissions
Please refer to the corresponding sub-section of Rev 0; and Revs 2 to Rev 7.
19
As part of the continuing improvements at the facility Novartis Ringaskiddy Limited proposes to effect a
number of modifications to the treatment/abatement systems for the Solid Waste Incinerator (Emission
Point Reference Number 3), the Liquid Vapour Incinerator (Emission Point Reference Number 4) and the
Wastewater Treatment Plant (Emission Point Reference Number 100) during the coming year. All of the
proposed changes are designed to improve the operation of already reliable equipment.
4.5.1 Improvements Proposed for the Solid Waste Incinerator
4.5.1.1 Heat Exchanger Tube Bundle Replacement (from Rev 5 - Item complete)
4.5.1.2 Bagfilter Housing Upgrade (from Rev 5 - Item complete)
4.5.1.3 Introduction of New Control Software (from Rev 5 - Item complete)
4.5.1.4 Bagfilter Housing Replacement (from Rev 6 - Item complete)
4.5.1.5 Upgrade of Solid Waste Feed Hopper (from Rev 7 Item complete)
4.5.1.6 Upgrade to Discharge of Spent Lime and Activated Carbon (from Rev 8 Item complete)
4.5.1.7 Heat Exchanger Replacement (from Rev 10 Item complete)
4.5.1.8 Study on Heat Recovery (from Rev 10 Item complete)
4.5.1.9 Upgrading of Reburn Tunnels (New Access Points (from Rev 11 Item complete)
4.5.1.10Upgrading of Reburn Tunnels (Installation of Air Injection Plenum) (from Rev 11 Item complete)
4.5.1.11 Installation of Waste Feed Conveyor System (from Rev 12 Item complete)
4.5.1.12 Installation of Heat Recovery on the Solid Waste Incinerator (from Rev 15 Item complete)
4.5.1.13 Installation of High Efficiency Burners on the Solid Waste Incinerator (from Rev 15
Item on-going)
Reason for modification:
Following a review of energy use at the Solid Waste Incinerator it is proposed to replace the units
existing auxiliary burners that run on natural gas with new high efficiency burners that will
20
significantly reduce the consumption of natural gas while maintaining the required operating
temperatures while solid waste is being incinerated.
Anticipated results from modification:
The new burners are expected to result in a saving of approximately 10% in natural gas
consumption at the Solid Waste Incinerator.
4.5.2 Improvements Proposed for the Liquid Vapour Incinerator
4.5.2.1 Bypass of Wastewater Treatment Plant by Quench and Scrubber Stream (from Rev 5 Item
complete)
4.5.2.2 Additional Control on Combustion Air from Wastewater Treatment Plant (from Rev 5 - Item
complete)
4.5.2.3 Reuse of Condensate for Cooling of Induction Fans (from Revs 4 to 6 - Item complete)
4.5.2.4 New Fire Protection System for Computer Control System (from Rev 7 Item complete)
4.5.2.5 Installation of New Air Conditioning System in CEMs Cabin (from Rev 8 Item complete)
4.5.2.6 Replacement of Refractory Lining (from Rev 9 Item complete)
4.5.2.7 Replacement of Flue Gas Reheater Heat Exchanger (from Rev 10 Item complete)
4.5.2.8Upgrade Induction Fan to a Variable Speed Drive (from Rev 14 Item on-going)
Both existing induction fans have been operational for more than 10 years and require
replacement.
Installation of induction fans with variable speed drives will facilitate better optimisation of
combustion (adjusting to the calorific load on the unit); and will also be more energy efficient.
4.5.2.8Upgrade to Reheater at Liquid Vapour Incinerator (from Rev 15 Item complete)
21
4.5.3 Improvements Proposed for the Wastewater Treatment Plant
4.5.3.1 Provision of Additional Storage Space Near the Blower Building (from Rev 5 - Item complete)
4.5.3.2 Upgrading of Flow Control on Blowers to the Aeration Basins

(from Revs 4 and 5 Item complete)
4.5.3.3 Addition of Third Aeration Basin and Second Clarifier (from Rev 5 - Item complete)
4.5.3.4 Installation of Interconnection Line between the Aeration Basins and Second Clarifier
(from Rev 6 - Item complete)
4.5.3.5 Replacement of Neutralisation Chamber Pumps (from Rev 6 - Item complete)
4.5.3.6 Installation of Duplex Filters in Lift Station (from Rev 6 - Item complete)
4.5.3.7 Installation of New Mechanical/Electrical Workshop in Environmental Controls Building

(from Rev 6 - Item complete)
4.5.3.8 Installation of a New Conveyor System for Dewatered Sludge (from Rev 8 Item complete)
4.5.3.9 Sealing of Neutralisation Basin and Spill Basins for Improved Odour Control (from Rev 9 Item
complete)
4.5.3.10New Composite Samplers for Emission Point Reference Numbers 100 and W1 (from Rev 10
Item complete)
4.5.3.11Provision of Secondary Containment for Lift Station (from Rev 11 Item complete)
4.5.3.12Provision of Secondary Containment for Neutralisation Basin (from Rev 11 Item complete)
4.5.3.13Provision of Additional Groundwater Monitoring Well (from Rev 11 Item complete)
4.5.3.14Increase Capacity of Air Blowers for Biological Treatment (from Rev 13 Item complete)
4.5.3.15Evaluation of Potential of Filtering Belt Filter Press Washwater (from Rev 13 Item complete)
4.5.3.16Installation of New Storage Area for WWTP Equipment (from Rev 14 Item on-going)
22
A secure location has been required for a number of portable items of Wastewater Treatment
Plant equipment these (mainly sections of metallic piping that are used for temporary
connections) have been stored in inappropriate locations from time-to-time (unpaved areas etc).
Improved housekeeping in the vicinity of the Wastewater Treatment Plant.
4.5.3.17Upgrading of Aeration System in use at the WWTP (from Rev 16 Item complete this
investment incurred a cost of 686,000)
23
4.5.4 Improvements Proposed for the Main Production Buildings
Please refer to the corresponding sub-section of Rev 4; and to subsection 4.1 of this document.
4.5.4.1 Addition of High Level Switch Protection to Emergency Relief Receivers

(From Rev 6 - Item complete)
4.5.4.2 Installation of Primary Bunding on the Ground Floor Corridor (from Rev 10 Item complete)
4.5.4.3Upgrading of Process Flow Chambers (directing flow to WWTP) (from Rev 16 Item on-going)
The company undertook to evaluate the potential benefits of upgrading the process flow
chambers where the process drains from the main production buildings are tied into the process
sewer system that drains to the Wastewater Treatment Plant as part of Rev 16 to the EMP. A
number of process flow chambers (including P48 (Production Building 2), P49 (Production
Building 2), P66 (Production Building 1)) were evaluated and consideration was also given to the
possible need for a new process flow chamber (which should be identified as chamber P37A)
adjacent to existing manhole P37 (Production Building 1A). The purpose of this chamber is that it
will allow for process flow monitoring from P37. The main upgrade that was evaluated was to
identify a suitable removable strainer/filter within each chamber so as any solids or debris passing
through the relevant chamber could be removed; and the chamber itself be more easily
maintained and inspected.
Improved access for inspection and cleaning of the process flow chambers; in addition to
improved retention of extraneous matter that might otherwise be directed to the wastewater
treatment plant. This work was scheduled to be undertaken during 2013; and the new process
flow chamber P37A was included as part of the scope of work. The work still needs to be finished
in P49 and P66 and this is dependent on a suitable production window being made available.
4.5.4.4Addition of High Level Overflow to Process Flow Chamber P48 (from Rev 17 Item complete)
24
4.6 The Use of Alternative Treatment/Abatement Systems
Please refer to the corresponding sub-section Rev 0 and Revs 3 to 7.
4.6.1 Redundancy Option on Liquid Vapour Incinerator (from Revs 5 to 8 Item complete)
4.6.2 Wet Electrostatic Precipitator Option on Liquid Vapour Incinerator (from Rev 9 Item complete)
4.6.3 Scrubbing Option on Redundant Vapour Treatment Module (From Rev 16 Item on-going)
The Redundant Vapour Treatment (RVT) Module of the Liquid Vapour Incinerator acts a sitewide
redundancy system to the Liquid Vapour Incinerator LVI for dealing with Volatile Organic Vapour
(VOC) off-gases and vapours (refer to item 4.6.1 of Revs 5 to 8). The module doesnt have the
facility to treat chlorinated vapours or off-gases containing traces of Hydrochloric Acid (HCl), so
when the RVT Module is on line, the emission licence limit for HCl can be exceeded resulting in
the need to stop certain process steps. This is not an issue with the Liquid Vapour Incinerator as
this unit has a water quench and a caustic scrubber to clean the exhaust gases. Another item to
be considered is that the RVT Modules equipment on the outlet of the burning chamber has
corroded over its ten year life due to the trace presence of unscrubbed HCl from the vapour
streams and needs to be upgraded. Consequently it is proposed to install a chlorine abatement
system to allow the RVT Module to treat chlorinated solvent vapours or vent gases containing HCl
when the main section of the Liquid Vapour Incinerator is offline. It is also proposed to upgrade
the equipment on the outlet of the units combustion chamber with new acid resistant components.
Two technical options to meet this requirement were evaluated throughout the course of 2012 and
one was decided on in early 2013. This was installed during the second-half of 2013 and full
functionality testing is scheduled for 2014. The total value of this investment is 1,974,000
The RVT Module will be able to function as a full back-up for the main section of the Liquid
Vapour Incinerator in respect of treatment of off-gases and vapours.
4.7 Recovery, Reuse, Recycling of Waste Material Both On-Site and Off-Site
4.7.1 Solvent Reuse and Recycling
Please refer to the corresponding sub-section of Rev 0; and Revs 2 to 5.
Project: Diovan Solvent Recovery Increased Solvent Recovery throughput (Update from Rev 14)
Current Status / Progress:
25
In absolute terms the following quantities of solvent were recovered between 2006 and 2013:
2006: 4,212 tonnes
2007: 5,165 tonnes
2008: 3,588 tonnes
2009: 6,222 tonnes
2010: 7,046 tonnes
2011: 4,102 tonnes
2012: 5,566 tonnes
2013: 4,367 tonnes
4.7.2 Metal Recycling
Refer to the corresponding sub-section of Rev 3; and Rev 9
During the course of revision 10 to the EMP all metal waste consigned off site for recycling was weighted
on the companys weight bridge and tracked through the companys Waste Tracking System (WTS). One
of the companys targets during the course Rev 11 to evaluate the possibility of reuse/reconditioning of
used metal drums in preference to recycling the used metal drums. However, on balance it was decided
that it remained a preferable option to have these metal drums recycled rather than reconditioned in the
unlikely event that there might be some residual contamination left in the drums.
4.7.3 Installation of Recycling Point
Refer to the corresponding sub-section of Revs 3 and 4.
26
4.7.4 Reuse of Inert Adsorbent Material
Refer to sub-section 4.1.3 of this document.
4.7.5 Recycling of Waste Oil
Refer to the corresponding sub-section of Revs 8, 9 and 10.
4.7.6 Improved Segregation of Non-Hazardous Waste
Refer to sub-section 4.1.7 of this document.
4.8 Reduction in Fugitive Emissions
Please refer to the corresponding sub-section of Revs 0 to 5.
The following table summarises the total fugitive emissions from the existing facility for the years 2007 -
2013.
____________________________________________________________________________________
Fugitive Emissions From the Existing Facility (expressed as kg organic carbon/year)

____________________________________________________________________________________
2007 2008 2009 2010 2011 2012 2013
7,396 3,740 3,244 2,181 3,476 5,039 9,807
(Production volume 2007: 426 tonnes; Production volume 2013: 393 tonnes)
____________________________________________________________________________________
27
4.9 Prevention of Incidents with the Potential for Environmental Consequences and the
Preparation and Implementation of Contingency Plans in the Event of an Incident
As indicated in Rev 6 during 2000 Novartis Ringaskiddy Limited prepared a Major Accident Prevention
Policy (MAPP) document to meets its requirements under the Control of Major Accident Hazards
Regulations, 2000 (S.I. Number 476 of 2000). This document was finalised towards the end of 2001 and
forwarded to the relevant competent body in the State, the Health and Safety Authority (HSA). The MAPP
document complements the contents of this section of the EMP, and was reproduced as an insert in Rev
7 of the EMP.
As noted in Rev 8 the company prepared a Safety Report in anticipation of (the then) future requirements
arising under the Control of Major Accident Hazards Regulations 2000, which were subsequently updated
to the European Communities (Control of Major Accident Hazards Involving Dangerous Substances)
Regulations, 2006 (S.I. Number 74 of 2006). This Safety Report was forwarded to the relevant competent
body in the State, the HSA during the course of Rev 11. This was reviewed and approved by the HSA
during the course of Rev 12.
A full update to the Safety Report is required for any major changes to the facility that may impact on the
risk presented both on- and off-site; or every five years. In the absence of any major change at the facility
the next full update of the Safety Report was undertaken during 2012. This document was issued for
review by the HSA during 2013.
A copy of the revised Safety Report is retained on site for inspection by the Agency.
4.9.1 General Overview
Please refer to the corresponding sub-section of Rev 0 and the MAPP document (See Rev 7); and the
companys Safety Report.
4.9.2 Prevention of Incidents with the Potential for Environmental Consequences
companys revised Safety Report of 2013.
The company plans to make a number of investments over the course of 2014 that will entail minimising
some of the hazards identified in the revised Safety Report:
The company proposes to install a series of three gullies along the Tank Farm road to the south
of the Tank Farm in 2014. The purpose of the gullies is to provide a mechanism of tertiary
containment in the event of a tank failure and subsequent containment basin over-topping. The
natural gradient in the area is a southerly flow towards the production buildings and the gullies will
28
contain any over-topping at the Tank Farm road and prevent the possibility of a flow of material to
production causing a domino effect.
The company also proposes to construct a 2.1 meter high wall between the above ground
installation (AGI) for the natural gas supply in the Environmental Controls Area and the Slow Fill
Area (where liquid waste solvent is loaded to road tankers for consignment off-site). This wall will
provide a physical barrier against any potential gas jet fire from the natural gas AGI causing
damage to a road tanker at the tanker Slow Fill Area (or pool fire causing a gas explosion).
Both of these projects will incur an investment of approximately 138,000
The company is also going to relocate the one waste solvent loading area located to the north of
the Liquid Vapour Incinerator to the Slow Fill Area in the Environmental Controls Area. This will
remove a significant safety and environmental hazard and this project will incur an investment of
approximately 360,000
4.9.3 Hazard Potential of Chemicals in use at Novartis Ringaskiddy Limited
companys revised Safety Report of 2013.
4.9.4 Preparation and Implementation of Contingency Plans

in the Event of an Incident
Please refer to the corresponding sub-section of Revs 0 to 5 and the MAPP document (See Rev 7); and
the companys revised Safety Report of 2013.
The components of the Novartis Emergency Management (NEM) system are fully described in section
4.9 of Rev 0 and the MAPP document (See Rev 7); and the companys revised Safety Report of 2013.
29
4.10 Savings in Energy and Materials Usage
4.10.1 Savings in Energy Usage
Please refer to the corresponding sub-section of Revs 0 to 12 and to section 4 of the 2008 Annual
Environmental Report (AER).
The following is a summary of energy conservation initiatives undertaken since Rev 8:
4.10.1.1 Replacement of chilled water condensers (Electricity) (from Rev 8 - Item complete with an
estimated GJ reduction of 900).
4.10.1.2 Reduction chilled water system users setpoint to 1.2 bar (Electricity) (from Rev 8 - Item
complete with an estimated GJ reduction of 200).
4.10.1.3 Reduction for evaporation requirements in the Cyclosporine process as a result of

introduction of the new purification process (Electricity) (refer to subsection 4.1 of this
document and Rev 8) (from Rev 8 - Item complete with an estimated GJ reduction of
12,779).
4.10.1.4 Reduction of lyophilizer drying time on the Fluvastatin process (Electricity) (Projected GJ
saving of 1,452) (from Rev 8 - Project deferred to 2007).
4.10.1.5 Reduction of condensing pressure on process chillers and operation of both water chillers
(Electricity) (from Rev 8 - Item complete with an estimated GJ reduction of 1,800).
4.10.1.6 Improved oxygen trim control on the companys second natural gas fired boiler (Natural
Gas) (from Rev 8 - Study completed in 2004 and implemented in 2005 with an estimated
GJ reduction of 2,010).
4.10.1.7 Reduction in the use of once through hot water in mobile filters in the production areas
(Natural Gas and Electricity) (from Rev 8 - Item complete with an estimated GJ reduction
of 3,083).
4.10.1.8 Removal of the chilled water booster pump (Electricity) (from Rev 8 - Item complete with
an estimated GJ reduction of 133).
4.10.1.9 Operation of both water chillers (Electricity) (Projected GJ saving of 216) (from Rev 9 -
Following a technical evaluation it was decided not to proceed with this project).
30
4.10.1.10 Produce a report on water usage at the facility focusing in particular on Cooling Tower
make-up, reverse osmosis and once through use of water (Water) (Potential GJ saving of
300) (from Rev 9 Item complete the report was prepared and a number of projects
were initiated).
4.10.1.11 Installation of energy efficient lighting in Production Building 1 (Electricity) (from Rev 9
Item complete with an estimated GJ reduction of 456).
4.10.1.12 Implementation of a new passivation procedure in Production Building 1 (Electricity) (from

Rev 9 Item complete with an estimated GJ reduction of 39)
4.10.1.13 Upgrade cooling water pumps (Electricity) (Projected GJ saving of 11,498) (From Rev 10
and also identified in the water usage report Item complete with an estimated GJ
reduction of 8,482))
4.10.1.14 Reduce chilled water flow rate (Electricity) (Projected GJ saving of 651) (From Rev 10 and
also identified in the water usage report project currently continuing on an on-going
basis)
4.10.1.15 Develop a proposal for a new energy efficient replacement option for the companys
existing use of glycol as a chiller refrigerant (From Rev 10 - ongoing) (Electricity)
(Projected GJ saving of 2,239) (Note that actual implementation of this project will not take
place during 2008/2009 a certain amount of preparatory work was undertaken during
2008/2009)
4.10.1.16 Installation of energy efficient lighting in the Tank Farm area (Electricity) (From Rev 11 -
Item complete with an estimated GJ reduction of 456)
4.10.1.17 Installation of NIR detector on Fluvastatin driers (Electricity) (From Rev 12 Item compete
with an estimated GJ reduction of 72)
4.10.1.18 Installation of NIR detector on Valsartan driers (Electricity) (From Rev 12 Item complete
with an estimated GJ reduction of 396)
See comments for item 4.10.1.18 above
4.10.1.19 Installation of Additional On-site Electricity Meters (Electricity) (From Rev 13 Item
complete)
4.10.1.20 Installation of New On-site Gas Meters (Natural Gas) (From Rev 13 Item complete)
4.10.1.21 Installation of energy efficient lighting in Production Building 2 (Electricity) (From Rev 13
Item complete with an estimated GJ saving of 456)
31
4.10.1.22 Modification to Glivec Production Process (Electricity) (From Rev 13 Item complete with
an estimated GJ saving of 540)
4.10.1.23 Compressed Air System Upgrade (Electricity) (From Rev 14 Item complete with an
estimated GJ saving of 9,163)
4.10.1.24 Optimise Use of Cooling Water (Electricity) (From Rev 14 Item complete with an
4.10.1.25 Increase Supply Temperature of Cold Glycol (Electricity) (From Rev 14 Item on-going)
(Projected GJ saving of 1,512)
Working in collaboration with the Production Process Units the Technical Services Support
Unit will identify ways to increase the supply temperature of cold glycol from the existing
supply temperature of 25 oC to 20 oC. A number of production processes will need to
be reviewed to ensure that the quality of the product is not adversely affected by
increasing the supply temperature. However, this has been identified as an area where
real progress can be made following an external review of patterns of energy consumption
within the facility.
4.10.1.26 Reduce Refrigeration Condenser Pressure (Electricity) (From Rev 14 Item complete with
an estimated GJ saving of 1,814)
4.10.1.27 Reduce Requirement for Pumping Hot Glycol (Electricity) (From Rev 14 Item on-going)
(Projected GJ saving of 3,421)
Working in collaboration with the Production Process Units the Technical Services Support
Unit will identify ways of ensuring that the hot glycol that is supplied from the Utility area is
used productively. This has been identified as an area where some progress can be made
following an external review of patterns of energy consumption within the facility.
4.10.1.28 Chilled Water Plant Upgrade (Electricity) (From Rev 15 Item complete with an estimated
GJ saving of 5,418)
4.10.1.29 Boiler Stand-by Heating Coil (Natural Gas) (Item complete with an estimated GJ saving of
5,058)
4.10.1.30 Recovery of Low Grade heat from Liquid Vapour Incinerator (Natural Gas) (From Rev 15
Item complete with an estimated GJ saving of 135,921)
32
4.10.1.31 Planning Application for Two 3MW Wind Turbines (Electricity) (From Rev 15 Item
complete Planning permission for a 3MW has been granted)
4.10.1.32 Upgrade to (external) Site Lighting (Electricity) (From Rev 16 Item complete with an
4.10.1.33 Investigate potential energy savings in Solvent Recovery through heat integration (Natural
Gas) (From Rev 17 Item on-going) (Projected savings of 20,600 GJ)
The Energy and Water Assessment that was undertaken at Novartis Ringaskiddy Limited
between 14-Nov-2012 and 16-Nov-2013 by energy experts from Novartis Pharma AG and
energy consultants from BMG Engineering Limited identified some potential energy
savings in the sites Solvent Recovery facility that will be evaluated during 2013. These
include investigation of heat integration particularly for the 108/109 continuous process
recovery columns. It may be possible to use condensation heat at high temperature for the
first column; and then use an evaporate sump at a lower temperature for the second
column, which could potentially result in lower steam consumption of the order of 800
kg/hour).
4.10.1.34 Replacement of compressed air supply filters (Electricity) (From Rev 17- Item complete
with an estimated GJ saving of 525)
4.10.1.35 Replacement of air supply to Wastewater Treatment Plant (Electricity) (From Rev 16- Item
complete with an estimated GJ saving of 5,655)
Note that this project was initially listed under the section detailing improvements to be
made at the companys Wastewater Treatment Plant. In addition to the significant
operational improvements that the new system brought there were also significant energy
savings in electricity use of the order of 5,655 GJ per annum.
4.10.1.36 Implement a new energy efficient replacement option for the companys existing use of
glycol as a chiller refrigerant (Initiated during Rev 10) (Electricity) (Projected GJ saving of
2,239)
Note that actual implementation of this project will now take place during September of
2014. A total investment of 2,291,100 is anticipated for this project.
Implementation of these measures is overseen by the sites Energy Management Group, which is chaired
by the Technical Services Support Unit but which has representatives from all of the main energy
consuming areas on site. The Energy Management Group meets once a month to review progress on the
implementation of the various energy conservation programmes.
33
4.10.2 Savings in Materials Usage
Refer to sub-section 4.7 of this document.
4.11 Prevention of Emissions of Carcinogenic Substances
Novartis Ringaskiddy Limited is not using any of the compounds which are known to be carcinogenic for
man (Category 1 Carcinogens) to which the Safety, Health and Welfare at Work (Carcinogens)
Regulations, 2001 (Statutory Instrument Number 78 of 2001) and the Safety, Health and Welfare at Work
(Chemical Agents) Regulations, 2001 (Statutory Instrument Number 619 of 2001) and its associated
Code of Practice of 2011 apply.
The company may use three compounds, in limited quantities, which carry the risk phrases
R45 May cause cancer
R49 May cause cancer by inhalation
R46 May cause heritable genetic damage
Two of the compounds, Dimethyl Sulphate and Hydrazine Hydrate, have not been used at Novartis
Ringaskiddy Limited to-date. The other, 2-Amino-4-Nitrotoluene, has been used in limited quantities
under enclosed handling conditions.
The company has implemented the Third Schedule of the Safety, Health and Welfare at Work
(Carcinogens) Regulations, 2001 (Statutory Instrument Number 78 of 2001) which defines the approach
to be taken when handling such materials. The company has planned to:
Limit the quantities of these substances stored and used at Novartis Ringaskiddy Limited.
Keep as low as possible the number of employees handling these materials.
Avoid the release of these materials into the workplace or the environment through the
used of Closed Production Systems.
Define those personal protective measures that are required by personnel working with
such materials.
Use an extraction system to vent such Closed Production Systems to the site's Liquid
Vapour Incinerator.
Apply appropriate Standard Operating Procedures when handling these compounds.
34
Operate a defined cleaning/hygiene regime in areas where such materials are being
handled.
Provide suitable training and information for employees working with these materials.
Use sealed containers, clearly and visibly labelled, when storing, handling or transporting
these materials.
Provide a means for safe collection, storage and disposal of carcinogenic or mutagenic
waste by employees, including the use of double lined and sealed containers that are
clearly and visibly labelled.
Designate special areas within the production building where these materials are handled.
For example, 2-Amino-4-Nitrotoluene was only handled in two designated areas.
The aforementioned procedures are also implemented when physically isolating certain reaction mixtures
that contain a constituent known to produce a positive Ames test. A positive Ames test for a substance
indicates that there may be a possibility that the substance could be carcinogenic. This provides an
additional safeguard in relation to the goal of preventing emissions of carcinogenic substances, both in
the workplace and in the environment.
A third category of carcinogen/mutagen exists and while these fall outside the specific scope of the
Carcinogen Regulations they must still be assessed under the Safety, Health and Welfare at Work Act
and the Chemical Agents Regulations.
Category 3 carcinogens are defined as substances which cause concern owing to possible carcinogenic
effects but the available information is not adequate. There is some evidence from animal studies but this
is insufficient to place the substance in category 2. A similar definition is given to category 3 mutagens.
Category 3 substances are labeled:
R40 Limited evidence of carcinogenic effect
R68 Possible risk of irreversible effects
The company uses/manufactures the following materials that contain either one or both of these labels:
Cyclosporine A; Methylene chloride; Epothilon A; and Imatinib Mesylate.
All of the aforementioned procedures are also applied when handling these substances.
The company continuously updates its material safety data information to take account of new
information becoming available on the materials which are in use at Novartis Ringaskiddy Limited and
also to take cognisance of changing occupational exposure limits under the aforementioned legislation.
35
4.12 Relevant Employee Training
Please refer to the corresponding sub-section of Revs 0 to 10; Revs 15 to 17.
Function specific training in the area of solvent recovery, control of emissions to atmosphere, surface
water protection and wastewater treatment plant operations is scheduled for personnel in the
Environmental Controls Department to build on targeted training received by this group under Revs 0 to
17. A new curriculum has been built for each individual working in the area of Environmental Controls and
this curriculum will be implemented during the course of 2013 and 2014. Some of the key topics to be
covered during the 2014 round of training include:
Control of Major Accident Hazards
Permit Awareness for Operators
Model of a Major Tank Farm Incident
New Aeration Diffusion System at the Wastewater Treatment Plant
HVAC Isolation Training
The HSE Support Unit also runs periodic induction courses for new personnel on site (both new company
employees and contract personnel) which covers, among other things, the companys operation under
the auspices of the EPAs IPPC licensing regime and the sites participation in the EMAS scheme. This
induction also covers key aspects of the environmental training module that was run during 2012.
Other conduits for raising general environmental awareness are the minutes of the meetings of the Site
Environmental Committee; the workings of the Energy Management Group, and EMAS related
documentation, which is available to all personnel via PC. The HSE Support Unit also maintains an
informative webpage on the companys internal intranet.
4.13 Novartis Ringaskiddy Limited: European Pollutant Release and Transfer Register
Please refer to the corresponding sub-section of Revs 0 to 13.
The companys E-PRTR report for the calendar year 2013 has been reported in electronic format to the
Agency (29-Mar-2014). A hard copy of the electronic submission can be found in section 4.0 of the 2013
AER.
The company proposes to continue to include, where appropriate, the following pollutants from Annex II
of the E-PRTR Regulation (EC) No 166/2006 concerning the establishment of a European Pollutant
Release and Transfer Register, in its 2014 E-PRTR:
36
____________________________________________________________________________________
Annex II Number Pollutant
2 Carbon monoxide
3 Carbon dioxide
7 Non-methane volatile organic compounds
8 Nitrogen oxides
11 Sulphur oxides
12 Total Nitrogen
13 Total Phosphorus
14 Hydrochlorofluorocarbons
20 Copper
24 Zinc
35 Dichloromethane
47 PCDD + PCDF (dioxins and furans)
73 Toluene
76 Total organic carbon
79 Chlorides
83 Fluorides
____________________________________________________________________________________
37
4.14 Novartis Ringaskiddy Limited: Public Information on Environmental Activities
In addition to continuing the activities outlined in sub-section 4.14 of Rev 0 and subsequent revisions the
company will be issuing the following document to the general public for 2013 (a copy will also be
provided to the EPA):
Novartis Ringaskiddy Limited Environmental Statement 2010 to 2012 (Prepared to Meet the
Requirements of the European Communitys EMAS Regulation) (Covering the Sites
Environmental Performance during the calendar years 2010 to 2012).
It is anticipated that Novartis Ringaskiddy Limited will issue an independently verified interim
Environmental Statement (covering the calendar year 2013) during the second-half of 2014. This
document will be made available to a wide audience.
To meet the requirements of Condition 3.2 of IEL Register Number P0006-03 an Installation Notice Board
has been erected at the main entrance to the facility. The board contains the following information:
The name and telephone number of the installation;
The normal hours of opening;
The name of the licence holder;
An emergency out of hours contact telephone number;
The licence reference number; and
Where environmental information relating to the installation can be obtained.
4.15 Sound Level Survey
Novartis Ringaskiddy Limited will submit a separate proposal in respect of the proposed sound level
survey for 2014 to the Agency. This proposal will meet the requirements of Condition 6.10; Schedule B.4
of IEL Register Number P0006-03; and relevant Agency guidance on sound level surveys. A report on the
survey that is to be undertaken during 2014 will be included in the AER for 2014.
4.16 Programme for Reduction in Sound Level Emissions from Specified Sources
Please refer to the corresponding sub-section Rev 0 and Rev 8.
38
No further work is scheduled for 2014. The annual sound survey report included in the 2013 AER
indicates that the company is complying with the terms of its IEL in respect of sound emissions from the
facility.
4.17 Programme for the Protection of Surface Water
4.17.1 General Overview
Please refer to the corresponding sub-section of Rev 0 and Rev 2.
4.17.2 Warning and Action Levels
4.17.3 Reference Drawing Numbers
4.17.4 Improvements Proposed for the Surface Water Protection System
4.17.4.3 New Tanker Parking Facility (From Revs 6 and 7 Item complete)
4.17.4.4 Installation of New Submersible Pumps in Storm Water Retention Pond

(From Rev 7 Item complete)
4.17.4.5 Installation of Retention Capacity Monitoring in Storm Water Retention Pond (from Rev 8
Item complete)
4.17.4.6 Installation of Primary Bunding on the Ground Floor Corridor (Also reference in sub-
section 4.5.4.2 of this EMP) (from Rev 10 Item complete)
4.17.4.7 New Bunded Storage Facility (from Rev 10 Item complete)
4.17.4.8 Installation of a Class I Full Retention Separator (from Rev 10 Item complete)
39
4.17.4.9 Maximise Retention Capacity of Spill Basin 2 (from Rev 13 Item complete)
4.17.4.10 Increase Capacity of SWRP from 5,000 m3 to 10,000 m3 (From Rev 14 Item complete)
4.17.4.11 Install a Low Flow Transfer Station at the SWRP (From Rev 14 Item complete)
4.17.4.12 Increase Holding Capacity of Spill Basins 1 and 2 (From Rev 16 Item complete The
Arup report Review of Tankfarm and Category 6 Warehouse Bund Capacity, 04 July
2013) confirms that the capacity of Spill Basin 1 is now 299 m3 and the capacity of Spill
Basin 2 is now 162 m3)
4.17.4.13 Increase Holding Capacity of Spill Basin 2 (From Rev 16 Item complete - The
Arup report Review of Tankfarm and Category 6 Warehouse Bund Capacity, 04 July
2013) confirms that the proposed modification to Spill Basin 2 (640.285) involving its
associated pumps; pipework and automation that would enable Spill Basin 2 to be pumped
out to a low level has been implemented)
4.17.4.14 Connection of Category 6 Warehouse Sumps to Bunded Sewer Network (From Rev 16
Item complete The Arup report Review of Tankfarm and Category 6 Warehouse Bund
Capacity, 04 July 2013) confirms that the necessary infrastructural work has been
undertaken to connect all of the floor drains and sumps within the Category 6 warehouse
(area 661) to the bunded sewer network (020.285))
4.17.4.15 Connection of Fuel Oil and Glycol Bunds to Process Sewer (From Rev 16 Item complete
All changes implemented as outlined in Rev 16))
4.17.4.16 Additional Precautions for the Storage of Acetic Acid and Sodium Hydroxide (From Rev 16
Item complete The automation change as outlined in Rev 16 has been implemented;
however it was decided to install a conductivity probe rather than a pH probe in Catchment
Basin 5 (where Sodium Hydroxide tank 652.201 is located). This will alarm in the event of
it detecting an increase in conductivity (- detecting a Sodium Hydroxide leak). An
automation change associated with installing this probe was made such that in the event
of a high conductivity alarm in Catchment Basin 5 the alarm will interlock all transfers into
and all transfers out of Acetic tank 652.201. Transfers will remain interlocked until such
time as any issue has been resolved and the conductivity alarm has been reset.
4.17.4.17 Surface Water Protection Improvement Projects 2013/2014 (New Item)
A number of surface water protection improvement projects are scheduled to be

undertaken over the course of 2013/2014. These include:
40
Upgrading of the tiled bunded area located to the east of the Equalisation Tank in the
Wastewater Treatment Plant Area (2013) (Item now complete)
Repositioning of a valve set at Spill Basin 1 to ensure that it operates within a

catchment/bunded area in line with IPPC Licence requirements (2013) (Item now
complete)
Upgrading of the Storm Water Retention Pond software to include a capacity alarm for
Environmental Controls Department operators (2014) (Item now complete)
Undertake all remedial works identified in the CCTV survey of the sites surface water
drainage system (2013) (Item now complete)
Reinstatement of the integrity of the sanitary sewer that runs from the Sports Clubs house
that is located on the west side of the site (2014).
Installation of a new drain in the Cooling Tower to facilitate ease of drainage to the process
sewer when testing and inspection is required (2014).
The schedule of works form part of an environmental Capital Allocation Request valued at
170,000 that has been approved on-site to enhance environmental protection at the
facility. The projects identified above will provide additional protection for surface water at
the facility.
4.17.4.18 Replacement of On-line TOC Analyser (New Item)
The existing unit has been operational for a number of years and the availability of spare
parts and technical support for the existing unit is becoming an issue. A total investment of
99,000 is to be made on this project.
Continued on-line monitoring of surface water with high availability.
4.18 Groundwater Quality and Identification of Contamination
Please refer to the corresponding sub-section of Rev 0 and Rev 1.
The companys on-going programme of groundwater sampling and analysis will be continued in 2013 to
meet the requirements of Schedule C.6 of IEL Register Number P0006-03. Data submitted to the Agency
to-date have indicated that the quality of the groundwater beneath the site at Novartis Ringaskiddy
Limited has remained the same as that prior to the commencement of the development.
41
The groundwater monitoring points listed in Schedule C.6 of IEL Register Number P0006-03 have been
included in the site's maintenance programme and will be inspected on a biannual basis. Any necessary
maintenance will be carried out based on this inspection.
Condition 9.4.4 of IPCL Register Number 545, which came into force on 31-Oct-2000, required that:
'The licensee shall undertake a programme of testing and inspection of underground tanks and pipelines
to ensure that all underground effluent and foul sewer pipes are tested at least once every three years. A
report on such tests shall be included in the Annual Environmental Report.'
A proposal in respect of testing and inspection of underground tanks and pipelines (based on a three
year cycle) was included as part of the revision to the company's EMP included as part of the year 2000
AER. The provisions of Condition 9.4.4 of IPCL Register Number 545 were new at that time in respect of
this facility. A report on the implementation of the relevant part of the EMP was subsequently furnished as
part of the reporting requirements of IPCL Register Number 545 in the 2003 AER.
The company advised the Agency that the second round of testing and inspection of underground tanks
and pipelines was to be undertaken before the end of 2006 in revision 10 to the EMP. This work was
subsequently undertaken and was reported on separately in the AER for 2006.
Condition 9.4.4 of IPCL Register Number 545 has subsequently superseded by Condition 6.8 of IEL
Register Number P0006-03, which requires that:
The integrity and water tightness of all underground pipes and tanks and their resistance to penetration
by water or other materials carried or stored therein shall be tested and demonstrated by the licensee.
This testing shall be carried out by the licensee at least one every three years thereafter and reported to
the Agency on each occasion. A written record of all integrity tests and any maintenance or remedial work
arising from them shall be maintained by the licensee.
The fourth round of testing was completed in 2012 and a report on the outcome of the testing programme
was submitted to the Agency as an addendum to the AER for 2012.
The fifth round of testing is scheduled to be completed no later than 2015 and a report on the outcome of
the testing programme will be submitted to the Agency as an addendum to the AER for 2015.
42
5.0 EXPECTED RESULTS OF THE NOVARTIS RINGASKIDDY LIMITED
ENVIRONMENTAL MANAGEMENT PROGRAMME
5.1 General Comments
Novartis Ringaskiddy Limited is convinced that the EMP that is in place guarantees the highest standards
in safety and environmental protection. This EMP is revised and updated on an annual basis. The
information provided in this document and the preceding revisions of the EMP, in the form of Annual
Safety and Environmental Performance Reports, and in the sites Environmental Statements of 1996,
1998, 2000, 2003, 2006; 2009 and 2012 confirm that this is the case. Novartis Ringaskiddy Limited is
committed under the terms of its participation in the European Communitys EMAS scheme to appraise
the general public of its performance in this regard.
5.2 Emissions from Production and Chemical Storage Equipment
Please refer to the corresponding sub-section of Rev 0; and Revs 1 to 12.
Quantitative information in respect of this performance is available in summary form for 1994 on page
number 8 of Rev 0; for 1995 on page number 10 of Rev 1 for 1996; for 1997 on pages number 8 and 9 of
Rev 3; for 1998 on page number 19 of Rev 4; for 1999 on page number 19 of Rev 5; for 2000 on page
number 21 of the insert in Rev 6; for 2001 on page number 48 of the insert in Rev 9; for 2002 on page
number 71 of the insert in Rev 12; for 2005 on page number 72 of the insert Rev 12; for 2006 on page
number 76 of the insert Rev 15; for 2009 on page number 77 of the insert in Rev 15; for 2010 on page
number 47 of the insert in Rev 16; and for 2011 on page number 47 of the insert in Rev 17.
The verified data for 2012 is summarised on the following page.
The data for 1994 to 2012 have been independently verified as part of the companys participation in
EMAS.
Novartis Ringaskiddy Limited is currently reporting on the results of implementation of Rev 17 of the EMP
to the EPA as part of the company's AER for 2013; and the company is scheduled to report on the effects
of implementing this current (Rev 18) proposal as part of the AER for 2014.
43
VERIFIED DATA 2012 EMAS CORE INDICATORS 2012
GENERAL FIGURES____________________ AIR EMISSIONS________________________
Total HSE Investments: 6,954,855 Sulphur dioxide: < 1 tonne
Investments for Environmental Nitrogen oxides: 14 tonnes

Protection: 3,370,630
Particulates: < 1 tonne
Total HSE Costs: 14,950,104
Carbon dioxide: 18.622 tonnes
Costs for Environmental
Protection: 13,177,572 Carbon monoxide: < 1 tonne

(LVI and SWI only)

(LVI and SWI only)
Total Personnel: 545
Organic carbon: 5.0 tonnes
Total Production: 441.870 tonnes (fugitive emissions)

Site Area: 53 ha
Built Area: 35 ha
WASTE_______________________________
Amenity Area: 18 ha
CONSUMPTION OF RESOURCES_________
Total water consumption: 262,895 m 3 Treated: 11 tonnes
Total energy consumption: 441,837 Disposed of: 242 tonnes

GigaJoules

(On-site solar panels)......................GigaJoules
Fresh solvent consumption: 9,846 tonnes On-site incineration with heat recovery: 2,926 tonnes
On-site solvent recovery: 5,566 tonnes

WATER DISCHARGES__________________
Off-site incineration with heat recovery: 7,381 tonnes
3
Total treated effluent discharged: 542 m /day Off-site solvent recovery: 317 tonnes
Suspended solids: 10 tonnes Other waste for off-site recovery: 97 tonnes
Biochemical oxygen demand: 3 tonnes

Treated: 1,942 tonnes
Chemical oxygen demand: 31 tonnes On-site incineration without heat recovery: 495 tonnes
Total nitrogen: 1 tonne On-site wastewater treatment: 251 tonnes
Off-site treatment (primarily incineration 1,196 tonnes

Total phosphorus: < 1 tonne without heat recovery):
Data rounded to the nearest tonne Data rounded to the nearest tonne
44
5.3 Compliance with Industrial Emissions Licence Register Number P0006-03
The EMP in place at Novartis Ringaskiddy Limited guarantees an extremely high degree of compliance
with the very strict conditions stipulated in the company's IEL. The company performs approximately
228,000 readings (tests) per year to check its compliance with the aforementioned licence. The company
has set an internal objective to show a minimum compliance of 99.9 %. This means that 200 readings out
of 200,000 could be associated with non-compliances presenting the potential for an adverse effect on
the environment. However, the company is confident that all non-compliances will be shown to be minor
deviations and not, in fact, presenting the potential for having an adverse effect on the environment. The
company will report all non-compliances, if there are any, together with an evaluation of their implication,
to the EPA.
The overall environmental compliance of Novartis Ringaskiddy Limited in respect of the imposed licence
conditions was 99.98 % during the period from January to December, 2013 (inclusive). Fifty-four readings
out of a total of more than 228,000 were judged to be in non-compliance and were reported to the
Environmental Protection Agency. All non-compliances were judged to be minor deviations and did not
present the potential for having an adverse effect on the local environment.
It is noteworthy that despite this transparent and long-term commitment to improving environmental
performance that implementation of IEL Register Number P0006-03 necessitated an approximate 71%
increase in environmental analyses (from approximately 133,000 analyses per annum in 2005 to
approximately 228,000 analyses per annum in 2013); together with additional regulatory requirements.
45
5.4 Expected Progress 2014
Novartis Ringaskiddy Limited sees, at this point in time, no major opportunity to decrease its emissions
because they are already at a very low level for an operation of this nature and are better than the results
which would be expected through the implementation of Best Available Technology as outlined in the
relevant EPA Sector Guidance Documents.
Compliance with the company's strict IEL is very high and the company will make every effort to maintain
this standard.
The company has also made significant progress in the area of resource management over the past
number of years and will commit itself to monitor, report and maintain the high standard that has been set
and where appropriate better these standards.
The key targets that form the basis of the 2014 EMP are summarised as follows. Some of these items will
run over a number years and this is indicated where appropriate:
Schedule of Environmental Targets for 2014:
1. All Process and Support Units. The agreed 2014 overall site hazardous waste target is set at
38.16 kg hazardous waste/kg of product shipped (which is an 8% reduction on the 2010 figure of
41.48 kg/kg). Plan activities to meet the Novartis Pharma 2010 to 2015 hazardous waste
reduction target (Fourth year of five year programme). Note that this expression of the target
includes on-site solvent recovery activities.
(To support the objective of reusing/recycling more of the hazardous waste that is generated on-
site (optimisation of the use of natural resources); and the objective of striving for continual
improvement in our HSE performance)
2. All Process and Support Units. The agreed 2014 overall site non-hazardous waste target is set
at 4.0278 kg non-hazardous waste/kg of product shipped (which is an 8% reduction on the 2010
figure of 4.378 kg/kg). Plan activities to meet the Novartis Pharma 2010 to 2015 non-hazardous
waste reduction target (Fourth year of five year programme).
(To support the objective of reusing/recycling more of the non-hazardous waste that is generated
on-site (optimisation of the use of natural resources); and the objective of striving for continual
3. Technical Services Support Unit. Coordinate site projects and activities to meet the agreed
overall site energy target for 2014 of an 8% reduction on the relative consumption of natural gas
and electricity when compared to the 2008 baseline figure of 1.4113 GJ/kg (Fourth year of five
year programme). This gives a target of 1.2984 GJ/kg to work towards. Plan activities to meet the
Novartis Pharma HSE 2015 energy optimisation target (Current five year programme).
(To support the objective of conducting our business in as sustainable a manner as is possible;
the objective of optimising the use of natural resources; and the objective of striving for continual
46
4. Technical Services Support Unit. Coordinate site projects and activities to meet the overall site
water efficiency target of a 3% reduction on the 2013 relative water consumption figure of 0.67
m3/kg. This gives a target of 0.65 m3/kg to work towards. Plan activities to support the 2013
Novartis Pharma HSE water consumption target.
(To support the objective of conducting our business in as sustainable a manner as is possible;
the objective of optimising the use of natural resources; and the objective of striving for continual
5. Technical Services Support Unit. Achieve an internal compliance rate of 99.98% (or greater) in
respect of the number of Out Of Expectation (OOE) results reported for operation of
environmental controls modules. An OOE result is one that is outside the normal operating range
but one which is still compliant with IEL requirements.
(To support the objective of measuring progress and verifying compliance with National regulatory
requirements)
6. Technical Services Support Unit. Install a quench and scrubbing system on the Redundant
Vapour Treatment (RVT) Module exhaust. The system should cool the exhaust stream and
remove Hydrochloric Acid (HCl), meeting Emission Point Reference Number 4s HCl Emission
Limit Value while the RVT Module is on line.
(To support the objective of striving for continual improvement in our HSE performance; the
objective of verifying compliance with National regulatory requirements; and the objective of
conducting our business in as sustainable a manner as is possible)
7. Technical Services Support Unit. Full implementation of CAR Numbers 2012055 and 2013042
in respect of improving surface water protection at the facility. Full revision of the procedures in
respect of operation of the Storm Water Retention Ponds. Improved management of the 2013 to
2015 bunds, containment basins and underground pipeline testing and inspection programmes.
(Five year programme initiated after the EPA audit of 2011 and running until 2015)
(To support the objective of striving for continual improvement in our HSE performance; the
objective of verifying compliance with National regulatory requirements; and the objective of
conducting our business in as sustainable a manner as is possible)
47
6.0 REFERENCES
6.1 Sandoz Ringaskiddy Limited: Application to the Environmental Protection Agency for an
Integrated Pollution Control Licence, 01-Sep-1994.
6.2 Integrated Pollution Control Licence Register Number 6. Issued to Sandoz Ringaskiddy Limited by
the Environmental Protection Agency, 16-May-1995.
6.3 Integrated Pollution Control Licence Register Number 545. Issued to Novartis Ringaskiddy Limited
by the Environmental Protection Agency, 31-Oct-2000.
6.4 Integrated Pollution Prevention and Control Licence Register Number P0006-03. Issued to
Novartis Ringaskiddy Limited by the Environmental Protection Agency, 02-Feb-2006.
6.5 Industrial Emissions Licence Register Number P0006-03. Technical Amendment to Integrated
Pollution Prevention and Control Licence Register Number P0006-03. Issued to Novartis
Ringaskiddy Limited by the Environmental Protection Agency, 30-Dec-2013.
6.6 Greenhouse Gas Emissions Permit Register Number GHG078-1. Issued to Novartis Ringaskiddy
Limited by the Environmental Protection Agency, 29-Mar-2004.
6.7 Greenhouse Gas Emissions Permit Register Number IE-GHG078-2. Issued to Novartis
Ringaskiddy Limited by the Environmental Protection Agency, 23-Sep-2005.
6.8 Greenhouse Gas Emissions Permit Register Number IE-GHG078-3. Issued to Novartis
Ringaskiddy Limited by the Environmental Protection Agency, 12-Aug-2008.
6.9 Greenhouse Gas Emissions Permit Register Number IE-GHG078-10386-1. Issued to Novartis
Ringaskiddy Limited by the Environmental Protection Agency, 18-Jul-2013.
6.10 Sandoz Ringaskiddy Limited. Environmental Management Programme (16-Nov-1995).
6.11 Sandoz Ringaskiddy Limited: First Revision to Environmental Management Programme (18-Nov-
1996).
6.12 Novartis Ringaskiddy Limited: Second Revision to Environmental Management Programme (21-
Nov-1997).
6.13 Novartis Ringaskiddy Limited: Third Revision to Environmental Management Programme (07-Dec-
1998).
48
6.14 Novartis Ringaskiddy Limited: Fourth Revision to Environmental Management Programme (15-
Dec-1999).
6.15 Novartis Ringaskiddy Limited: Fifth Revision to Environmental Management Programme (01-Feb-
2001).
6.16 Novartis Ringaskiddy Limited: Sixth Revision to Environmental Management Programme (01-Feb-
2002).
6.17 Novartis Ringaskiddy Limited: Seventh Revision to Environmental Management Programme (31-
Mar-2003).
6.18 Novartis Ringaskiddy Limited: Eighth Revision to Environmental Management Programme (01-
Apr-2004).
6.19 Novartis Ringaskiddy Limited: Ninth Revision to Environmental Management Programme (01-Apr-
2005).
6.20 Novartis Ringaskiddy Limited: Tenth Revision to Environmental Management Programme (01-
Apr-2006).
6.21 Novartis Ringaskiddy Limited: Eleventh Revision to Environmental Management Programme (01-
Apr-2007).
6.22 Novartis Ringaskiddy Limited: Twelfth Revision to Environmental Management Programme (01-
Apr-2008).
6.23 Novartis Ringaskiddy Limited: Thirteenth Revision to Environmental Management Programme

(01-Apr-2009).
6.24 Novartis Ringaskiddy Limited: Fourteenth Revision to Environmental Management Programme

(01-Apr-2010).
6.25 Novartis Ringaskiddy Limited: Fifteenth Revision to Environmental Management Programme (01-
Apr-2011).
6.26 Novartis Ringaskiddy Limited: Sixteenth Revision to Environmental Management Programme (01-
Apr-2012).
49
6.27 Novartis Ringaskiddy Limited: Seventeenth Revision to Environmental Management Programme

(01-Apr-2013).
6.28 Sandoz Ringaskiddy Limited: Report on the Implementation of the Environmental Management
Programme of 16-November-1995 (03-Feb-1997).
6.29 Novartis Ringaskiddy Limited: Report on the Implementation of the First Revision to
Environmental Management Programme (11-Feb-1998).
6.30 Novartis Ringaskiddy Limited: Report on the Implementation of the Second Revision to
6.31 Novartis Ringaskiddy Limited: Report on the Implementation of the Third Revision to
6.32 Novartis Ringaskiddy Limited: Report on the Implementation of the Fourth Revision to
6.33 Novartis Ringaskiddy Limited: Report on the Implementation of the Fifth Revision to
6.34 Novartis Ringaskiddy Limited: Annual Environmental Report 2001 (01-Feb-2002).
6.35 Novartis Ringaskiddy Limited: Annual Environmental Report 2002 (01-Apr-2003).
50
6.44 Novartis Ringaskiddy Limited: Annual Environmental Report 2011 (31-Oct-2012).
6.45 Novartis Ringaskiddy Limited: Annual Environmental Report 2012 (31-Aug-2013).
6.47 Sandoz Ringaskiddy Limited. Safety and Environmental Performance 1994.
6.48 Sandoz Ringaskiddy Limited. Safety and Environmental Performance 1995.
6.49 Sandoz Ringaskiddy Limited: Environmental Statement 1996 (Covering the year 1995) (Prepared
to Meet the Requirements of the European Communitys EMAS Regulation).
6.50 Novartis Ringaskiddy Limited: Environmental Statement 1998 (Covering the years 1996 and 1997)
(Prepared to Meet the Requirements of the European Communitys EMAS Regulation).
6.51 Novartis Ringaskiddy Limited: Environmental Statement 1998 to 2000 (Prepared to Meet the
Requirements of the European Communitys EMAS Regulation).
6.56 Planning Register Reference Number S/2989/89 (Decision by An Bord Pleanla following appeal
of Planning Register Reference Number S/2989/89 (Original Decision by Cork County Council))
6.57 Council Regulation (EC) No 1221/2009 Allowing Voluntary Participation by Organisations in a

Community Eco-Management and Audit Scheme (EMAS).
51
6.58 Novartis Ringaskiddy Limited: Major Accident Prevention Policy. December, 2001. Prepared to
meet the requirements of the Control of Major Accident Hazards Regulations, 2000 (S.I Number
476 of 2000).
6.59 Novartis Ringaskiddy Limited: Safety Case 2008. Prepared to meet the requirements of the
European Communities (Control of Major Accident Hazards Involving Dangerous Substances)
Regulations, 2006 (S.I. Number 74 of 2006).
6.60 Novartis Ringaskiddy Limited: Safety Case 2013. Prepared to meet the requirements of the
European Communities (Control of Major Accident Hazards Involving Dangerous Substances)
Regulations, 2006 (S.I. Number 74 of 2006).
52
Environmental Management Programme - Report 2013
Progress in Resource Conservation Activities
Novartis Ringaskiddy Limiteds seventeenth revision to its EMP (dated 01-Apr-2013) and
covering the period 2013 continued to shift the emphasis from making continued progress in the
area of resource management and conservation towards consolidating the progress that had
been made over the past number of years. In addition to this process of consolidation a series
of specific targets were elaborated for 2013 (continuing a process that commenced in 2004) and
these are reported on elsewhere in this Annual Environmental Report. The following areas were
identified as ones in which consolidation of previous progress would be maintained:
Natural gas consumption.
Electricity consumption.
Water consumption.
Fugitive emissions to atmosphere.
Hazardous waste to be treated.
Non-Hazardous waste to be disposed.
Rectification of solvent material.
Updates on progress in relation to resource management and conservation based on

implementation of the companys EMP during 2013 are presented on the following pages. Data
on natural gas, electricity and water consumption are based on meter readings; data on fugitive
emissions are based on regular measurements; while the data on hazardous and non-
hazardous waste and rectified solvent material are based on the companys measurements
and/or records.
Input in the following assessments is expressed per kilogramme of final product. Note that
savings in water, natural gas and electricity consumption should lead to reduced wastewater
discharge volumes to be treated and to reduced emissions (less running time of boilers and
utility plant).
The 2009 to 2013 figures are based on actual data. The actual data for the years 2009 to 2012
have also been independently verified as part of the companys participation in EMAS and it is
anticipated that the data for the year 2013 will be independently verified as part of the
companys participation in EMAS during the first half of 2014.
Note that there was a significant impact on many of the environmental metrics reported on in
this section of the 2011 AER due to the later than anticipated start-up of the new E1W process
in the Diovan Process Unit during the first-quarter of 2011. Novartis Ringaskiddy Limited
demonstrated significant material and energy savings. These savings have been effected
primarily through process modification and optimisation; and there is further scope for saving as
the new process is established by increasing yield. A full years savings could not be realised
during 2011 as the new process was only successfully established at the end of the first-
quarter. A clearer view of the new process impact can be seen in the data set for 2012 and
2013.
Water consumption. Average water consumption in 2013 was 0.57 m3/kg of drug
substance shipped. This data is compared with data from the year 2009 in the
accompanying bar chart. Note that while the relative water consumption in 2013 was
slightly higher than 2012 it was still less than the years 2009, 2010 and 2011.
Natural gas and electricity consumption. In 2013, Novartis Ringaskiddy Limited

consumed a total of 404,531 GigaJoules (GJ) of energy compared to 441,836 GJ in
2012. There was a very slight increase in the companys relative energy consumption
when expressed as GJ per kg of product shipped: Up from 1.00 GJ/kg of product shipped
during 2012 to a figure of 1.03 GJ/kg of product shipped during 2013. Note from the
accompanying graphs for natural gas and electricity consumption that the overall long-
term trend continues to be positive and the 2013 relative energy consumption figure is
comparable with the 2012 figure, which was an historic low for the facility.
Fugitive emissions to atmosphere. There was an increase in fugitive emissions between

2012 and 2013 up from 0.011 kg of organic carbon/kg of product shipped to 0.025 kg of
organic carbon/kg of product shipped. Additional monitoring will be undertaken during
2014 with a view to returning the relative emission rate to a rate comparable with the
preceding four years. The relative emission rate that was recorded during 2013 was
typical of the levels recorded between 2000 and 2007; and may be an artefact of the
reduced monitoring that was undertake during 2013. The data reported for 2013 is not of
especial environmental significance.
Rectification of solvent material. There was a decrease in the actual amount of solvent
material recovered in the facilitys solvent recovery unit between 2012 and 2013: Down
from a figure of 5,566 tonnes recovered during 2012 to a figure of 4,367 tonnes
recovered during 2013. This reflected a reduced volume of suitable solvent material for
recovery, which arose from a change to the profile of the companys product portfolio.
The relative amount of solvent recovered at the facility has decreased from 12.60 kg/kg
of product shipped during 2012 to 11.10 kg/kg of product shipped during 2013.
Hazardous waste to be treated. The total amount of hazardous waste that is generated at
the facility was reduced from a figure of 54.66 kg/kg of product shipped in 2011 to a
figure of 41.26 kg/kg of product shipped in 2012 or a relative reduction of approximately
25%. This performance marked an historic low for the company and represents the
culmination of the implementation of a number of very successful waste management
optimisation programmes. Unfortunately this figure increased to 46.60 kg/kg of product
shipped in 2013, which arose primarily for the need to ship significant quantities of
aqueous waste off-site during a period of operational difficulty with the companys
Wastewater Treatment Plant during the months of May. June and July of 2013.
Non-Hazardous waste to be treated/disposed. There was an increase in the total amount

of non-hazardous waste that is generated at the facility between 2012 and 2013: Up from
a figure of 4.12 kg/kg of product shipped in 2012 to a figure of 5.60 kg/kg of product
shipped in 2013. Notwithstanding this there was a significant improvement in the relative
amount of non-hazardous waste that was sent for reuse and/or recycling: up from a
figure of 3.55 kg/kg of product shipped in 2012 to a figure of 5.28 kg/kg of product
shipped in 2013.
Water Consumption:
Water consumption is expressed as m3 consumed per kilogramme of product manufactured.
1
m3 water/kg product
0.9
0.8
0.7
0.6
0.5
0.4
0.3
0.2
0.1
0
2009 2010 2011 2012 2013
Natural Gas Consumption:
Natural Gas consumption is expressed as GigaJoule consumed per kilogramme of product

manufactured.
0.9
0.8 gigajoule/kg product
0.7
0.6
0.5
0.4
0.3
0.2
0.1
0
2009 2010 2011 2012 2013
Electricity Consumption:
Electricity consumption is expressed as GigaJoule consumed per kilogramme of product

manufactured.
0.6
0.5
0.4
0.3
0.2
0.1
0
2009 2010 2011 2012 2013
Hazardous Waste to be Treated:
Hazardous Waste to be treated is expressed as tonne treated per kilogramme of product

manufactured.
0.007
0.006
0.005
0.004
0.003
0.002
0.001
0
2009 2010 2011 2012 2013
Non-Hazardous Waste to be Treated/Disposed:
Non-Hazardous Waste to be treated/disposed of is expressed as tonne per kilogramme of

product manufactured.
0.0006
0.0005 tonne/kg product
0.0004
0.0003
0.0002
0.0001
0
2009 2010 2011 2012 2013
Fugitive Emissions:
Fugitive emissions from Production Buildings 1, 1A and 2 (the main production and purification
buildings) are expressed as kilogramme of Organic Carbon emitted per kilogramme of product
manufactured.
0.025
kg/kg product
0.02
0.015
0.01
0.005
0
2009 2010 2011 2012 2013
Rectified Solvent:
Solvent rectified (not including material recycled within the production buildings) is expressed as
kilogramme per kilogramme of product manufactured.
18
kg/kg product
16
14
12
10
0
2009 2010 2011 2012 2013
European Pollutant Release and Transfer Register (PRTR) - Report for 2013
The requirement to prepare a Pollutant Release and Transfer Register (PRTR) arises from the
requirements of Schedule D of IEL Register Number P0006-03; and the Agencys
correspondence on the subject dated 18-Jan-2007, which was included in Attachment Number
1 of the corresponding section of the AER for 2006. At the time the company proposed to
include, where appropriate, the following pollutants from Annex II of the E-PRTR Regulation
(EC) No 166/2013 concerning the establishment of a European Pollutant Release and Transfer
Register in its 2013 E-PRTR and will do likewise for the 2013 E-PRTR:
____________________________________________________________________________
Annex II Number Pollutant
2 Carbon monoxide
3 Carbon dioxide
7 Non-methane volatile organic compounds
8 Nitrogen oxides
11 Sulphur oxides
12 Total Nitrogen
13 Total Phosphorus
14 Hydrochlorofluorocarbons
20 Copper
24 Zinc
35 Dichloromethane
47 PCDD + PCDF (dioxins and furans)
73 Toluene
76 Total organic carbon
79 Chlorides
83 Fluorides
____________________________________________________________________________
The E-PRTR data for 2013 was submitted to the Agency in electronic format (as required).
Attachment Number 1 contains a hard copy summary of the aforementioned data.
Attachment Number 1
Sheet : Releases to Air AER Returns Workbook 6/5/2014 16:7
4.1 RELEASES TO AIR Link to previous years emissions data | PRTR# : P0006 | Facility Name : Novartis Ringaskiddy Limited | Filename : P0006_2013.xls | Return Year : 2013 | 06-05-2014 16:07
8 14 22 24 32 34 6 12 6 13 6 10 34
SECTION A : SECTOR SPECIFIC PRTR POLLUTANTS
RELEASES TO AIR Please enter all quantities in this section in KGs
POLLUTANT METHOD QUANTITY
Emission Point Emission Point Emission Point
Emission Point Emission Point Reference Reference Reference
Emission Point Reference Emission Point Reference Reference Number 01 Reference Number Number 05 Number 06 Number 07
Number 03 (Solid Waste Number 04 (Liquid Vapour (Utility Boiler Number 02 (Utility Boiler (Emergency (Firewater Pump (Firewater Pump
Method Used Incinerator) Incinerator) 1) Number 2) Generator) 1) 2)
A
T (Total) (Accidental) F (Fugitive)
No. Annex II Name M/C/E Method Code Designation or Description Emission Point 1 Emission Point 2 Emission Point 3 Emission Point 4 Emission Point 5 Emission Point 6 Emission Point 7 KG/Year KG/Year KG/Year
11 Sulphur oxides (SOx/SO2) M ALT 10/23-8.11 EN 5.0 172.0 0.0 0.0 0.0 0.0 0.0 177.0 0.0 0.0
08 Nitrogen oxides (NOx/NO2) M ALT 10/23-8.11 EN 846.0 7739.0 274.0 2116.0 0.0 0.0 0.0 10975.0 0.0 0.0
07 Non-methane volatile organic compounds (NMVOC) M ALT 10/23-8.11 EN 6.0 26.0 0.0 0.0 0.0 0.0 0.0 32.0 0.0 0.0
BS EN 1948-1: 2006 and
47 PCDD + PCDF (dioxins + furans)(as Teq) M PER BS EN 1948:96 0.000000031 0.000000163 0.0 0.0 0.0 0.0 0.0 ####### 0.0 0.0
BS EN 14385 and BS EN
18 Cadmium and compounds (as Cd) M ALT 13211 0.013 0.064 0.0 0.0 0.0 0.0 0.0 0.077 0.0 0.0
BS EN 14385 and BS EN
21 Mercury and compounds (as Hg) M ALT 13211 0.001 0.012 0.0 0.0 0.0 0.0 0.0 0.013 0.0 0.0
03 Carbon dioxide (CO2) C ETS 1623154.0 6978226.0 841797.0 4839337.0 164003.0 4316.0 4316.0 ####### 0.0 0.0
* Select a row by double-clicking on the Pollutant Name (Column B) then click the delete button
SECTION B : REMAINING PRTR POLLUTANTS

Site
Refrigerat
Emission Point Emission Point Emission Point ion and
Emission Point Reference Reference Reference Freeze
Emission Point Reference Emission Point Reference Emission Point Reference Number Number 05 Number 06 Number 07 Drying
Number 03 (Solid Waste Number 04 (Liquid Vapour Reference Number 01 02 (Utility Boiler (Emergency (Firewater Pump (Firewater Pump Equipme
Method Used Incinerator) Incinerator) (Utility Boiler 1) Number 2) Generator) 1) 2) nt
A
Emission T (Total) (Accidental F (Fugitive)
No. Annex II Name M/C/E Method Code Designation or Description Emission Point 1 Emission Point 2 Emission Point 3 Emission Point 4 Emission Point 5 Emission Point 6 Emission Point 7 Point 8 KG/Year ) KG/Year KG/Year
02 Carbon monoxide (CO) M ALT 10/23-8.11 EN 11.0 49.0 5.0 28.0 0.0 0.0 0.0 0.0 93.0 0.0 0.0
Off-site contract laboratory

84 Fluorine and inorganic compounds (as HF) M OTH test - BS EN 15713:2006 7.0 27.0 0.0 0.0 0.0 0.0 0.0 0.0 34.0 0.0 0.0
Estimation of losses based

on HCFC replacement
14 Hydrochlorofluorocarbons (HCFCs) E OTH requirements during 2013 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0
SECTION C : REMAINING POLLUTANT EMISSIONS (As required in your Licence)

Emission Point Reference Emission Point Reference

Number 03 (Solid Waste Number 04 (Liquid Vapour Production Building Production
Method Used Incinerator) Incinerator) Production Building 1 1A Building 2
F
A (Accidental) (Fugitive)
Pollutant No. Name M/C/E Method Code Designation or Description Emission Point 1 Emission Point 2 Emission Point 3 Emission Point 4 Emission Point 5 T (Total) KG/Year KG/Year KG/Year
244 Total Particulates M ALT 1.0 99.0 0.0 0.0 0.0 100.0 0.0 0.0

214 Hydrogen bromide M OTH test - US EPA Method 26 9.44 106.0 0.0 0.0 0.0 115.44 0.0 0.0
Estimation of fugitive
emissions of non-chlorinated
solvents to atmosphere from
diffuse sources - based on
237 Volatile organic compounds (as TOC) E OTH PID measurements 0.0 0.0 3382.0 1466.0 4959.0 9807.0 0.0 0.0
Additional Data Requested from Landfill operators
For the purposes of the National Inventory on Greenhouse Gases, landfill operators are requested to provide summary data on landfill gas
(Methane) flared or utilised on their facilities to accompany the figures for total methane generated. Operators should only report their Net methane
(CH4) emission to the environment under T(total) KG/yr for Section A: Sector specific PRTR pollutants above. Please complete the table below:
Landfill: Novartis Ringaskiddy Limited
Please enter summary data on the

quantities of methane flared and / or utilised Method Used
Designation or Facility Total Capacity m3
additional_pollutant_no T (Total) kg/Year M/C/E Method Code Description per hour
Total estimated methane generation (as per site
model) 0.0 N/A
Methane flared 0.0 0.0 (Total Flaring Capacity)
Methane utilised in engine/s 0.0 0.0 (Total Utilising Capacity)
Sheet : Releases to Air AER Returns Workbook 6/5/2014 16:7
Net methane emission (as reported in Section A

above) 0.0 N/A
4.3 RELEASES TO WASTEWATER OR SEWER Link to previous years emissions data | PRTR# : P0006 | Facility Name : Novartis Ringaskiddy Limited | Filename : P0006_2013.xls | Return Year : 201306-05-2014
| 16:07
8 15 23 25 6 6 6 6 25
SECTION A : PRTR POLLUTANTS
OFFSITE TRANSFER OF POLLUTANTS DESTINED FOR WASTE-WATER TREATMENT OR SEWER Please enter all quantities in this section in KGs
Emission Point Reference
Method Used Number 100
No. Annex II Name M/C/E Method Code Designation or Description Emission Point 1 T (Total) KG/Year A (Accidental) KG/Year F (Fugitive) KG/Year
EO 025 - Off-site contract
laboratory test - Purge and
73 Toluene M CRM Trap/GC/MS 0.095 0.095 0.0 0.0
EM 130 - Off-site contract
20 Copper and compounds (as Cu) M CRM laboratory test 4.0 4.0 0.0 0.0
EM 130 - Off-site contract
24 Zinc and compounds (as Zn) M CRM laboratory test 3.0 3.0 0.0 0.0
EW146 - Off-site contract
13 Total phosphorus M CRM laboratory test 589.0 589.0 0.0 0.0
EW 140 - Off-site contract
12 Total nitrogen M CRM laboratory test 1628.0 1628.0 0.0 0.0
Based on ENVCM-021 -
76 Total organic carbon (TOC) (as total C or COD/3) C OTH test 15536.0 15536.0 0.0 0.0
SAL Reference 212423
001 - Based on US EPA
Method 1613 - Off-site
47 PCDD + PCDF (dioxins + furans)(as Teq) M CRM contract laboratory test 0.0 0.0 0.0 0.0
EW154M-1 - Off-site
06 Ammonia (NH3) M CRM contract laboratory test 66.0 66.0 0.0 0.0
SECTION B : REMAINING POLLUTANT EMISSIONS (as required in your Licence)

OFFSITE TRANSFER OF POLLUTANTS DESTINED FOR WASTE-WATER TREATMENT OR SEWER Please enter all quantities in this section in KGs
Method Used
Pollutant No. Name M/C/E Method Code Designation or Description Emission Point 1 T (Total) KG/Year A (Accidental) KG/Year F (Fugitive) KG/Year
ENVCM-021 - Off-site
306 COD M CRM contract laboratory test 46608.0 46608.0 0.0 0.0
EW 001 - Off-site contract
303 BOD M CRM laboratory test 1581.0 1581.0 0.0 0.0
ENVCM-034 - Off-site
240 Suspended Solids M CRM contract laboratory test 16962.0 16962.0 0.0 0.0
Schedule of Objectives and Targets 2013 (Update)
Note that these Objectives are not a Requirement of IEL Register Number P0006-03
The schedule of environmental objectives and targets listed here are not a requirement of
Schedule D of IEL Register Number P0006-03. Further information on the objectives and
suggested benefits are described in Sections 4.0 and 5.0 of the 2013 Environmental
Management Programme (Rev 16)(which forms part of 2011 Annual Environmental Report).
1. All Process and Support Units. The agreed 2013 overall site hazardous waste target is
set at 38.99 kg hazardous waste/kg of product shipped (which is a 6% reduction on the
2010 figure of 41.48 kg/kg). Plan activities to meet the Novartis Pharma 2010 to 2015
hazardous waste reduction target (Third year of five year programme). Note that this
expression of the target includes on-site solvent recovery activities.
generated on-site (optimisation of the use of natural resources); and the objective of
striving for continual improvement in our HSE performance)
Status: A total of 46.60 kg of hazardous waste/kg of product shipped was generated

during 2014. This increase arose primarily for the need to ship significant quantities of
aqueous waste off-site during a period of operational difficulty with the companys
Wastewater Treatment Plant during the months of May. June and July of 2013. This was
unforeseen and an improvement in performance is anticipated during 2014.
target is set at 4.115 kg non-hazardous waste/kg of product shipped (which is a 6%
reduction on the 2010 figure of 4.378 kg/kg). Plan activities to meet the Novartis Pharma
2010 to 2015 non-hazardous waste reduction target (Third year of five year programme).
Status: There was an increase in the total amount of non-hazardous waste that is
generated at the facility between 2012 and 2013: Up from a figure of 4.12 kg/kg of
product shipped in 2012 to a figure of 5.60 kg/kg of product shipped in 2013.
Notwithstanding this there was a significant improvement in the relative amount of non-
hazardous waste that was sent for reuse and/or recycling: up from a figure of 3.55 kg/kg
of product shipped in 2012 to a figure of 5.28 kg/kg of product shipped in 2013.
agreed overall site energy target for 2013 of a 6% reduction on the relative consumption
of natural gas and electricity when compared to the 2008 baseline figure of 1.4113 GJ/kg
(Third year of five year programme). This gives a target of 1.3267 GJ/kg to work towards.
Plan activities to meet the Novartis Pharma HSE 2015 energy optimisation target
(Current five year programme).
(To support the objective of conducting our business in as sustainable a manner as is

possible; the objective of optimising the use of natural resources; and the objective of
Status: The relative consumption of natural gas and electricity during 2013 was 0.8909
GJ/kg of product shipped, which was significant ahead of the target figure.
consumption figure of 0.60 m3/kg of product shipped. This gives a target of 0.55 m3/kg of
product shipped to work towards. Plan activities to support the 2013 Novartis Pharma
HSE water consumption target.

Status: The relative consumption figure for water during 2013 was 0.67 m3/kg of product
shipped, which although higher than the figure of 0.59 m3/kg of product shipped that was
recorded in 2012 was still less than the relative amounts recorded in the other nine years
of the preceding ten years.
(To support the objective of measuring progress and verifying compliance with National
regulatory requirements)
Status: The total number of reportable deviations recorded during 2013 was 53
(primarily due to the operational difficulties encountered at the Wastewater Treatment
Plant during May, June and July of 2013). These deviations are described in greater
detail in Section 2 of this Annual Environmental Report).
exhaust stream and remove Hydrochloric Acid (HCl), meeting Emission Point Reference
Number 4s HCl Emission Limit Value while the RVT Module is on line.
(To support the objective of striving for continual improvement in our HSE performance;
the objective of verifying compliance with National regulatory requirements; and the
objective of conducting our business in as sustainable a manner as is possible)
Status: The new unit was installed at the end of 2013 and will undergo full functionality
testing in early 2014.
7. Technical Services Support Unit. Apply the rRCI methodology to understand the root
cause of the generation of Wastewater Treatment Plant biomass with a poor settlement
profile that results in non-compliant readings being recorded for discharges of Total
Suspended Solids at Emission Point Reference Number 100 (and the associated
Chemical Oxygen Demand).
Status: This process was applied over a number of weeks during May and June of 2013
and helped to identify the key causative factors behind the significant deterioration in the
performance of the companys Wastewater Treatment Plant during May, June and July.
Corrective actions were implemented; and these together with the subsequent
installation of a new aeration system for the biological section of wastewater treatment
resulted in a significant improvement in the performance of the Wastewater Treatment
Plant during the latter part of 2013.
Schedule of Objectives and Targets 2014
Note that these Objectives are not a Requirement of IEL Register Number P0006-03
The schedule of environmental objectives and targets listed here are not a requirement of
Schedule D of IEL Register Number P0006-03. Further information on the objectives and
suggested benefits are described in Sections 4.0 and 5.0 of the 2013 Environmental
Management Programme (Rev 18) (which forms part of this Annual Environmental Report).
1. All Process and Support Units. The agreed 2014 overall site hazardous waste target is
set at 38.16 kg hazardous waste/kg of product shipped (which is an 8% reduction on the
2010 figure of 41.48 kg/kg). Plan activities to meet the Novartis Pharma 2010 to 2015
hazardous waste reduction target (Fourth year of five year programme). Note that this
expression of the target includes on-site solvent recovery activities.
target is set at 4.0278 kg non-hazardous waste/kg of product shipped (which is an 8%
reduction on the 2010 figure of 4.378 kg/kg). Plan activities to meet the Novartis Pharma
2010 to 2015 non-hazardous waste reduction target (Fourth year of five year
programme).
(To support the objective of reusing/recycling more of the non-hazardous waste that is
agreed overall site energy target for 2014 of an 8% reduction on the relative consumption
of natural gas and electricity when compared to the 2008 baseline figure of 1.4113 GJ/kg
(Fourth year of five year programme). This gives a target of 1.2984 GJ/kg to work
towards. Plan activities to meet the Novartis Pharma HSE 2015 energy optimisation
target (Current five year programme).

consumption figure of 0.67 m3/kg. This gives a target of 0.65 m3/kg to work towards. Plan
activities to support the 2013 Novartis Pharma HSE water consumption target.
(To support the objective of measuring progress and verifying compliance with National
regulatory requirements)
exhaust stream and remove Hydrochloric Acid (HCl), meeting Emission Point Reference
Number 4s HCl Emission Limit Value while the RVT Module is on line.
7. Technical Services Support Unit. Full implementation of CAR Numbers 2012055 and
2013042 in respect of improving surface water protection at the facility. Full revision of
the procedures in respect of operation of the Storm Water Retention Ponds. Improved
management of the 2013 to 2015 bunds, containment basins and underground pipeline
testing and inspection programmes. (Five year programme initiated after the EPA audit of
2011 and running until 2015)
Section 4: Licence Specific Reports:
Report on List I and II Substance Reductions
Tank and Pipeline Testing and Inspection Report
Noise Monitoring Report
Groundwater Monitoring Summary
Energy Audit Report
Effluent Toxicity Report

Report on List I and II Substance Reductions 2013
There is no specific Condition in IEL Register Number P0006-03 in relation to reducing

emissions of List I and II substances. However, Condition 2.4 and Schedule 6 (i) of Integrated
Pollution Control Licence Register Number 6 required that:
"The licensee shall put in place a programme to identify methods by which a reduction in the
emissions of List II substances, and all priority candidate Black List substances, from the activity
may be achieved. The licensee shall provide a report to the Agency on an annual basis, setting
out the reductions achieved with regard to these compounds in the previous year, and also
setting out targets for improvement in the following year."
Novartis Ringaskiddy Limited proposes, subject to the agreement of the Agency, that it continue
to report in the format in which data on List I and II substances were reported during previous
years. To this end information for the years 1994 to 2013 is summarised on the following pages:
1. No Black List substances were used in production at Novartis Ringaskiddy Limited during
the years 1994 to 2013 (inclusive).
2. Of the so-called List II substances and priority candidate Black List substances Toluene
was used between 1994 and 2013 (inclusive); and Cyclohexane was used between 1995
and 2013 (inclusive).
3. Total annual volume discharges of treated effluent from the wastewater treatment plant at
Novartis Ringaskiddy Limited for the years 1994 to 2013 were as follows:
1994: 159,000 m3 1995: 137,400 m3
1996: 141,840 m3 1997: 148,545 m3
1998: 173,720 m3 1999: 193,000 m3
2000: 154,720 m3 2001: 207,320 m3
2002: 236,360 m3 2003: 245,910 m3
2004: 238,400 m3 2005: 246,280 m3
2006: 222,950 m3 2007: 212,320 m3
2008: 211,080 m3 2009: 206,415 m3

2010: 199,940 m3 2011: 170,729 m3
2012: 198,538 m3 2013: 188,676 m3
4. The total emission of Toluene from the facility to the aquatic environment between 1994
and 2013, based on independent characterisation by the EPA; Enterprise Ireland; BHP
Laboratories and Environmental Laboratory Services Limited (data previously submitted
both to Cork County Council (1994) and the EPA (1994 to 2013)) has been calculated as
follows:
1994: < 0.159 kg 1995: < 0.446 kg
1996: < 0.250 kg 1997: < 0.200 kg
1998: < 0.220 kg 1999: < 0.193 kg
2000: < 0.400 kg 2001: < 207.32 kgs (*)

(*) based on limit of detection
2002: < 236.36 kgs (*) 2003: < 245.91 kgs (*)
(*) based on limit of detection (*) based on limit of detection
2004: < 71.52 kgs (*) 2005: < 1.48 kgs (*)
2006: < 0.279 kg (*) 2007: < 1.062 kg (*)

2008: < 0.106 kg (*) 2009: < 0.103 kg (*)

2010: < 0.010 kg (*) 2011: < 0.100 kg (*)

2012: < 0.100 kg (*) 2013: < 0.100 kg (*)

Note that the figures are generally based on analytical results at the limit of detection of
the Gas Chromatography/Mass Spectrometry technique used. This data can also be
expressed as gram emission per kilogram of product produced:
1994: < 0.032 g/kg 1995: < 0.045 g/kg
1996: < 0.007 g/kg 1997: < 0.003 g/kg
1998: < 0.003 g/kg 1999: < 0.003 g/kg
2000: < 0.003 g/kg 2001: < 0.879 g/kg (*)

2002: < 0.869 g/kg (*) 2003: < 0.763 g/kg (*)
2004:< 0.239 g/kg (*) 2005:< 0.005 g/kg (*)

2006:< 0.001 g/kg (*) 2007:< 0.003 g/kg (*)

2008:< 0.001 g/kg (*) 2009:< 0.001 g/kg (*)

2010:< 0.001 g/kg (*) 2011:< 0.001 g/kg (*)

2012:< 0.001 g/kg (*) 2013:< 0.001 g/kg (*)

5. The total emission of Cyclohexane from the facility to the aquatic environment between
1995 to 2013, based on independent characterisation by the EPA; Enterprise Ireland; BHP
Laboratories and Environmental Laboratory Services Limited (data previously submitted
both to Cork County Council (1994) and the EPA (1994 to 2013)) has been calculated as
follows:
1995: < 0.900 kg 1996: < 1.000 kg
1997: < 0.800 kg 1998: < 0.910 kg
1999: < 0.965 kg 2000: < 0.774 kg
2001: < 207.32 kgs (*) 2002: < 236.36 kgs (*)
2003: < 245.91 kgs (*) 2004: < 166.88 kgs (*)
2005: < 2.47 kgs (*) 2006: < 11.15 kgs (*)
2007: < 10.62 kgs (*) 2008: < 21.11 kgs (*)
2009: < 20.65 kgs (*) 2010: < 19.994 kgs (*)
2011: < 17.08 kgs (*) 2012: < 19.86 kgs (*)
2013: < 18.87 kgs (*)

The analytical method of Gas Chromatography/Mass Spectrometry was used in

quantitation. This data can also be expressed as gram emission per kilogram of product
produced:
1995: < 0.100 g/kg 1996: < 0.030 g/kg
1997: < 0.010 g/kg 1998: < 0.009 g/kg
1999: < 0.011 g/kg 2000: < 0.006 g/kg
2001: <0.879 g/kg (*) 2002: < 0.869 g/kg (*)

2003: < 0.763 g/kg (*) 2004: < 0.557 g/kg (*)
2005: < 0.007 g/kg (*) 2006: < 0.033 g/kg (*)
2007: < 0.025 g/kg (*) 2008: < 0.067 g/kg (*)
2009: < 0.056 g/kg (*) 2010: < 0.051 g/kg (*)
2011: < 0.064 g/kg (*) 2012: < 0.045 g/kg (*)
2013: < 0.048 g/kg (*)

6. Because of the very low concentrations and total amounts of the substances in question, it
is not possible to set meaningful targets for reduction in emissions of these substances to
the aquatic environment. This is because most of the measurements used in quantifying
the emissions were, generally, quoted as limits of detection. Where positive results were
recorded they were in the range of the limits of detection.
7. Because the company is committed under the terms of its Industrial Emissions Licence to
regularly monitor the emissions of trace levels of organic compounds, including Toluene
and Cyclohexane, it will be possible to ascertain whether the existing condition of very low
emissions to the aquatic environment continues to prevail at Novartis Ringaskiddy Limited.
8. This data is presented in graphical form for the years 2008 to 2013 on the following pages.
0.12
0.1
0.08
0.06
0.04
0.02
0
2008 2009 2010 2011 2012 2013
Figure 1. Emissions of Toluene (in kgs) to the Aquatic Environment from Novartis
Ringaskiddy Limited (2007 to 2013)
0.001
0.0009
0.0008
0.0007
0.0006
0.0005
0.0004
0.0003
0.0002
0.0001
0
2008 2009 2010 2011 2012 2013
Figure 2. Emissions of Toluene (in g/kg product) to the Aquatic Environment from
Novartis Ringaskiddy Limited (2007 to 2013)
25
20
15
10
0
2008 2009 2010 2011 2012 2013
Figure 3. Emissions of Cyclohexane (in kgs) to the Aquatic Environment from

Novartis Ringaskiddy Limited (2007 to 2013)
0.07
0.06
0.05
0.04
0.03
0.02
0.01
0
2008 2009 2010 2011 2012 2013
Figure 4. Emissions of Cyclohexane (in g/kg product) to the Aquatic Environment

from Novartis Ringaskiddy Limited (2007 to 2013)
Tank and Pipeline Testing and Inspection Report 2013
Conditions 3.6.5; 3.11; and 6.8; and Schedule D, of IEL Register Number P0006-03 require
that:
"The integrity and water tightness of all the bunding structures and their resistance to
penetration by water or other materials stored therein shall be tested and demonstrated by the
licensee at least once every three years. This testing shall be carried out in accordance with any
guidance published by the Agency;
The provision of a catchment system to collect any leaks from flanges and valves of all over
ground pipes used to transport material other than water shall be examined. This shall be
incorporated into a schedule of objectives and targets set out in Condition 2.2 of this licence for
the reduction in fugitive emissions; and
"The integrity and water tightness of all underground pipes and tanks and their resistance to
penetration by water or other materials carried or stored therein shall be tested and
demonstrated by the licensee. This testing shall be carried out by the licensee at least once
every three years thereafter and reported to the Agency on each occasion. A written record of
all integrity tests and any maintenance or remedial work arising from them shall be maintained
by the licensee"
The companys first proposal in respect of testing and inspection of underground tanks
and pipelines was included as part of the revision to the company's EMP included as part
of the year 2000 AER. The provisions of Condition 9.4.4 of IPCL Register Number 545
were at that time new in respect of this facility. A report on the implementation of the first
round of testing, which commenced during the latter part of the year 2003, and the
inspection programme was submitted to the Agency as part of the AER for 2003.
A report on the implementation of the second round of testing and associated inspection
programme, which covered the period between 2004 and 2006, was submitted to the
Agency as part of the AER for 2006.
A report on the implementation of the third round of testing and associated inspection
A report on the implementation of the fourth round of testing and associated inspection
A schedule of works for those items that were identified during the latter testing period has a
number of items that are to be addressed during 2014. These were not identified at the time as
requiring immediate attention; and will be closed out prior to the commencement of the fifth
round of testing.
Two lines of the Sanitary Sewer system (SA50 to SA49; and SA 49 to SA47) require
repair work to be completed within 5 years and one line (SA47 to SA43) requires repair
work to be completed within 2 years.
The Sanitary Sewer system outfall line from the Waste Water Treatment Area (SA47 to
SA43) has some minor dips in the pipe and some distortion in the pipe shape just before
manhole SA 43. The integrity of the pipe has not been compromised and the line will be
surveyed on an annual basis until repair works are carried out.
The Waste Oil Bund (430-762-001) failed its hydrostatic test and has been taken out of
service. The reason for this failure is to be investigated, remedial measures are to be
identified and implemented and the bund will be subjected to a new hydrostatic test.
One of the channels in Warehouse 8 (451766003) failed the hydrostatic test. The
reason for this failure is to be investigated, remedial measures are to be identified and
implemented and the channel will be subjected to a new hydrostatic test. Note that the
main sump in Warehouse 8 (451-766-003) passed the hydrostatic test.
General cleaning is required to some of the fixed bunds within a three-year time period.
Eight of the 19 catchment basins inspected require some minor maintenance items to be
carried out within 2 years.
____________________________________________________________________________
The fifth round of testing and inspection of underground tanks and pipelines is to be completed
no later than the end of 2015; and will be reported on in the AER for the calendar year 2015.
In respect of the requirement to examine he provision of a catchment system to collect any

leaks from flanges and valves of all over ground pipes used to transport material other than
water Novartis Ringaskiddy Limited wishes to point out that all such flanges and valves are
effectively contained by the surface water protection system, which formed part of the design of
the facility at Novartis Ringaskiddy Limited. A description of this protection system, which
formed part of the company's proposal to the EPA (dated 03-Oct-1995) for the setting of action
and warning levels with reference to the quality of surface water leaving the site, is included as
part of the Annual Summary Report on Surface Water Emissions in this AER. Further
information on this system is contained in Attachment Number 22 of the company's original
application to the EPA for an Integrated Pollution Control Licence (dated 01-Sep-1994).
Information on the quality of surface water leaving Novartis Ringaskiddy Limited is summarised
for the EPA on a monthly basis. These monthly reports are held at the facility for inspection by
the Agency at any time. Any deviations in respect of surface water emissions are required to be
notified to the Agency as part of the quarterly reporting process under IEL Register Number
P0006-03. The monitoring data for 2013 indicated that all surface water leaving the facility was
of a quality suitable for discharge to the local Cork County Council storm sewer.
Of further interest in this regard is the application of the Novartis principle of containment in the
use of hard piped, closed systems. This concept has been extended to overhead pipes so that
the number of flanges are minimised and where possible they are substituted by welds which
are amenable to pressure and X-Ray testing.
Application of this system of containment from the design phase of the facility has ensured that
the quality of groundwater under the site has remained the same as that prior to the
commencement of the development at Novartis Ringaskiddy Limited. Confirmation of this is to
be found in the company's reports on groundwater monitoring, which are submitted to the EPA
on an annual basis. These reports confirm that the quality of the groundwater beneath the
facility at Ringaskiddy has remained the same as that prior to the commencement of the
development. The company is currently submitting groundwater monitoring data for 2013
(sampling dates: 19-Apr-2013 and 28-Sep-2013) as part of this AER. The data confirm that
groundwater beneath the Ringaskiddy site has not been affected by manufacturing activities at
Novartis Ringaskiddy Limited.
Consequently, the company is reporting that there were no reportable incidents involving leaks
from over-ground pipes and valves during 2013; and that all such potential emissions are
contained.
A copy of the most recent revision of Drawing Number 000-121018 Revision 4 Civil Register of
Bunds, Catchment Basins, Sumps and Storage Areas is included in Attachment I.
Attachment I
01 02 03 04 05 06 07 08 09 10
:55
NOTES
4:34
31
.2 01
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ne 8.N
. Sig xt ,0
Dig Kevin gTe
1. ALL LEVELS IN METRES POOLBEG DATUM.
r trin
a rne nS
W catio
Lo
2. THIS DRAWING INDICATES ALL BUNDED AREAS ONLY.
SECURITY FENCE
2K GATE
A
A FENCE 5B
CATCHMENT
ELECTRICAL No.10 CALOR GAS
SWITCH YARD TANK
2S TRUCK
CAT. 9 WAREHOUSE
UNLOADING
BOLLARDS
AREA
TANK FARM
VALVE
BUILDING HOUSE WAREHOUSE
2G 2J 2C SAFETY 5A
TRANSFORMER SHOWER
POTABLE SOLVENT
WATER TANK RECOVERY
(EAST)
PUMP
5F
SECURITY CATCHMENT CATCHMENT CATCHMENT CATCHMENT
5E
HOUSE 2E
GATE Nos.7&8 Nos.6&9 Nos. Nos.
E
C CONSTRUCTION CAR PARK 3&4 1&2
N
FIRE CAT. 3 & 4 5C
FE
WATER TANK 2A WAREHOUSE
CATEGORY 6.
1D CATCHMENT
WAREHOUSE
5D
Smoking SPILL
Hut No.5 2B
B BASIN B
Bicycle
V V V V Shed 2L 5G
BOLLARDS 2M 2N/2P/2Q
GAS STORAGE M.L. TANK
WESP
WC. KTN. ELECTRICAL 2H 2F 2D 2U
DORNAN
PROJECT TRASH
C/S/A
ALCOVE &
WAREHOUSE
INCINERATOR
MECH. LIQUID/VAPOUR
CONSTRUCTION SSF INCINERATOR
COMPOUND
2R
3D
BMD BMD 1E GAS PAD
TCH
STAINLESS STEEL CARBON STEEL

WWTA
WORK SHOP WORK SHOP
3C
PI
LIQUID ANNEX TRAILER PARK

PB 1A
PB 2 PB 1 3B
FLAME EXP
PLATFORM
ARRESTER
C C
TRANSFORMER
OFFICES BULIC CHARGING

TRANSFORMER

LIQUID NITROGEN LEGEND
SKID DHS SKID CONTROL BUILDING
CONSTRUCTION MANAGEMENT OFFICES
GATE 1N 1A 1P 1B 1L ACCESS STAIRS

PSA
TEMP ELEC HUT TRANSFORMER AIRLOCK
OFFICES
5R 3E PERMANENT BUNDS
SWITCHROOM
EAST / WEST CORRIDOR 3A
REDUNDANT
TRANS. PAD
LLER
BLOWER
EQUIPMENT BUILDING
CATCHMENT BASINS
AERATION
CHI
SECURITY FENCE FUEL
TANK
NG
OIL
TOW ER
COOLI
UTILITY BUILDING AERATION AERATION STORAGE AREAS DRAINING TO PROCESS SEWER
MAINTENANCE ICE PLANT
GEN. PAD
COMPOUND SPILL TANK TANK
BASIN 3F UNDERGROUND SUMPS
1M
AREA CLARIFIER
1C
DGE
REFERENCE DRAWINGS
BRI
1G
ON
5L
GH
ANALYZER
SATI
LIFT
W EI
1U MAIN
NEUTRALI
1H 1J 1K 5M STATION 5N SHED
TANK
2T
5P CHEMICAL
STORAGE 1F
D SECURITY FENCE
D
BUILDING BUILDING 5H
1Q
GAS METER
STATION
LOADING DOCK
SECURITY FENCE CANOPY
TRANSFORMER
IRISH GAS
GATE 16m WIDE SERVICES RESERVATION STATION
BICYCLE SHED
ADMINISTRATION
BUILDING
H
TC
DI
CAR PARK
SECURITY FENCE
E CAR PARK E
GUARD HOUSE
SECURITY FENCE
NIPBI BUILDING
STORM WATER ESB
1R
MAIN ROAD
1S
MAIN PLANT ENTRANCE

WATER METER
CAR PARK
HOUSE
F F
POND
REGISTER OF BUNDS, CATCHMENT BASINS, SUMPS & STORAGE AREAS DRAINING TO PROCESS SEWER
ID TITLE 9-DIGIT CODE ID TITLE 9-DIGIT CODE ID TITLE 9-DIGIT CODE ID TITLE 9-DIGIT CODE LOCATION ID TITLE 9-DIGIT CODE LOCATION ID TITLE 9-DIGIT CODE ID TITLE 9-DIGIT CODE
SECURITY FENCE
GATE
720
FENCE
CATCHMENT
663
ELECTRICAL No.10 CALOR GAS
655 TANK
SWITCH YARD 664
721
TRUCK
CAT. 9 WAREHOUSE
1 PERMANENT BUNDS 1R SWRP CHEMSTORE 1 014-762-002 2M LVI GROUND FLOOR 572-763-001 4 OUTDOOR MOBILE BUNDS/ BUNDED VESSELS - -
UNLOADING
MOBILE BUND 16 000-765-016 - LIQUID WASTE MOBILE VESSEL (BUNDED) 451-000-031 622
MAIN SWITCHGEAR
BUILDING
AREA
652
TANK FARM
CONTROL BUILDING (EAST)
651
BOLLARDS
SAFETY
VALVE
HOUSE
CAT. 2
WAREHOUSE
TRANSFORMER SHOWER
POTABLE SOLVENT 666
WATER TANK RECOVERY
(EAST)
PUMP CATCHMENT CATCHMENT CATCHMENT CATCHMENT
SECURITY
GATE 623
CONSTRUCTION CAR PARK 3&4 1&2
FIRE 653 CAT. 3 & 4
WAREHOUSE
662
1A UTILITY AREA GLYCOL BUND 430-762-001 1S SWRP CHEMSTORE 2 014-762-003 2N LVI FIRST FLOOR WASTE TANK STORAGE 572-763-002 - - -
CATCHMENT
WAREHOUSE
MOBILE BUND 1 000-765-001 GLYCOL DRUM HOLDING BUND - SERVICE YARD LIQUID WASTE MOBILE VESSEL (BUNDED) 451-000-032
SPILL
No.5
G MOBILE BUND 17 000-765-017 LAB. WASTE SOLVENT CAGE V V V V V V

BASIN
DORNAN
BOLLARDS
WC. KTN.
GAS STORAGE
BIO DETECTOR SKID
661 574
M.L. TANK
PLATFORM G
ELECTRICAL
PROJECT
561 TRASH
C/S/A
ALCOVE &
WAREHOUSE
510 552 INCINERATOR
CONSTRUCTION
MECH.
543 SSF
LIQUID/VAPOUR
572
INCINERATOR
COMPOUND Smoking
Hut
553 576
1B UTILITY AREA FUEL OIL BUND 430-762-002 1U WASTE OIL BUND 430-762-011 2P LVI FIRST FLOOR WASTE TANK STORAGE 572-763-003 - MOBILE BUND 2 000-765-002 OIL STORAGE CAGE - OUTSIDE ENG STORES - MOBILE BUND 18 000-765-018 EAST WEST CORRIDOR (PB2 LAYDOWN) 5 UNDERGROUND SUMPS BMD
STAINLESS STEEL
WORK SHOP
WORKSHOP
BMD
CARBON STEEL
WORK SHOP
GATE
550
QUENCH TANKS
BULK STORAGE
GAS PAD
WWTA
COMBUSTER
WORKSHOP
LIQUID PB 1A ANNEX TRAILER PARK 571
PB 2 PB 1
FLAME EXP
PLATFORM
ARRESTER
471
TRANSFORMER 575
OFFICES TRANSFORMER
540 BULIC CHARGING
LIQUID NITROGEN
GATE 421 431 554
SKID
CONTROL BUILDING
CONSTRUCTION MANAGEMENT OFFICES LAY DOWN
TEMP ELEC HUT AIRLOCK
PSA 470
TRANSFORMER
1C SPILL BASIN 1 474-762-001 2Q LVI FIRST FLOOR WASTE TANK STORAGE 572-763-004 - - 5A
SWITCHROOM
MOBILE BUND 3 000-765-003 OIL STORAGE CAGE - OUTSIDE ENG STORES MOBILE BUND 19 000-765-019 EAST WEST CORRIDOR (WAREHOUSE LAYDOWN) WAREHOUSE 2 SUMP 1 664-766-001 REDUNDANT
TRANS. PAD
LLER
BLOWER
EQUIPMENT BUILDING
AERATION
CHI
SECURITY FENCE FUEL
TANK
NG
OIL
475
TOW ER
COOLI
ICE PLANT 541
GEN . PAD
COMPOUND
474 SPILL TANK TANK
BASIN

420 AREA
442
CLARIFIER
441 473
430
ON
ANALYZER
SATI
LIFT
MAIN
NEUTRALI
STATION SHED
451 TANK
1D SPILL BASIN 2 640-762-001 2 CATCHMENT BASINS 2R BULK STORAGE TRAILER PARK 576-763-001 - MOBILE BUND 4 000-765-004 OIL STORAGE CAGE - OUTSIDE ENG STORES - MOBILE BUND 20 000-765-020 EAST WEST CORRIDOR (WAREHOUSE LAYDOWN) 5B WAREHOUSE 2 SUMP 2 664-766-002 SECURITY FENCE
GATE
432
TECHNICAL SERVICES
BUILDING
LABORATORY
BUILDING
GAS METER
STATION
CHEMICAL
STORAGE 472
SECURITY FENCE 342

TRANSFORMER
IRISH GAS
GATE STATION
BICYCLE SHED
1E SSF TANKER AREA BUND 561-762-001 2A CATCHMENT 1 652-763-001 2S AREA 655 TANKER OFFLOAD AREA 655-763-001 - MOBILE BUND 5 000-765-005 OIL STORAGE CAGE - OUTSIDE ENG STORES - MOBILE BUND 21 000-765-021 - WEST CORRIDOR (PB2 LAYDOWN CAGE)
EAST 5C WAREHOUSE 3 SUMP 1 662-766-001 341
ADMINISTRATION
BUILDING
CAR PARK 361

SECURITY FENCE
CAR PARK
GUARD HOUSE
SECURITY FENCE
NIPBI
NIPBI BUILDING
1F WWTP NEUTRALISATION CHEMICAL STORAGE AREA 470-762-001 2B CATCHMENT 2 652-763-002 2T UREA AND PHOSPHORIC ACID TROUGH 470-763-001 - - 5D
EXP.
MOBILE BUND 6 000-765-006 BULK STORAGE TRAILER PARK (CANOPY) WAREHOUSE 3 SUMP 2 662-766-002
STORM WATER ESB
MOBILE BUND 22 000-765-022 EAST WEST CORRIDOR (WAREHOUSE LAYDOWN)

- RETENTION POND SUB-STATION
014 MAIN ROAD
242
MAIN PLANT ENTRANCE

WATER METER
HOUSE
1G UTILITY AREA: CHEMSTORE 1 430-762-003 2C CATCHMENT 3 652-763-003 2U WAREHOUSE 6 CATCHMENT 661-763-001 - MOBILE BUND 7 000-765-007 RD TANKER STORAGE AREA ECD (CANOPY) - CMT BUND 1 510-765-001 BMD YARD 5E WAREHOUSE 4 SUMP 662-766-003 241
1H UTILITY AREA: CHEMSTORE 2 430-762-004 2D CATCHMENT 4 652-763-004 - MOBILE BUND 8 000-765-008 RD TANKER STORAGE AREA ECD (CANOPY) - CMT BUND 2 510-765-002 BMD YARD 5F WAREHOUSE 3/4 LOBBY SUMP 1 662-766-004
KEY PLAN
1J UTILITY AREA: CHEMSTORE 3 430-762-005 2E CATCHMENT 5 652-763-005 3 STORAGE AREAS WHICH DRAIN TO PROCESS SEWER - MOBILE BUND 9 000-765-009 BULK STORAGE TRAILER PARK (CANOPY) - CMT BUND 3 510-765-003 BMD YARD 5G WAREHOUSE 3/4 LOBBY SUMP 2 662-766-005
OWNER TECHNICAL OWNER

1K UTILITY AREA: CHEMSTORE 4 430-762-006 2F CATCHMENT 6 652-763-006 3A ALOX SHED 575-764-001 - MOBILE BUND 10 000-765-010 - - LAB LIQUID WASTE MOBILE VESSEL (BUNDED) 242-001-360 - 5H WAREHOUSE 5 SUMP 1 451-766-002
This document is the property of Novartis Ringaskiddy Limited and is not to be used, reproduced or disclosed
1L UTILITY AREA: COOLING TOWER BUND 1 430-762-007 2G CATCHMENT 7 652-763-007 3B WASTE WATER TA GENERAL STORAGE 571-764-001 - MOBILE BUND 11 000-765-011 COOLING TOWER DOSING TANK BUND - SERVICE YARD - LAB LIQUID WASTE MOBILE VESSEL (BUNDED) 242-001-361 - 5L WAREHOUSE 8 SUMP 451-766-003
H H
1M UTILITY AREA: COOLING TOWER BUND 2 430-762-008 2H CATCHMENT 8 652-763-008 3C LVI MOBILE VESSEL AREA 572-764-001 - MOBILE BUND 12 000-765-012 COOLING TOWER DOSING TANK BUND - SERVICE YARD - LAB LIQUID WASTE MOBILE VESSEL (BUNDED) 242-001-362 - 5M WW LIFT STATION SUMP 473-766-001 Novartis Ringaskiddy Limited
1N UTILITY AREA: GLYCOL CHARGING STATION BUND 430-762-009 2J CATCHMENT 9 652-763-009 3D SWI ASH PIT 572-764-002 - MOBILE BUND 13 000-765-013 COOLING TOWER DOSING BUND - LIQUID BROMINATING - LAB LIQUID WASTE MOBILE VESSEL (BUNDED) 441-001-030 - 5N NEUTRALISATION TANK SUMP 470-766-001
Drawing Title
1P UTILITY AREA: FUEL OIL PUMP BUND 430-762-010 2K CATCHMENT 10 652-763-010 3E WWTP ANTIFOAM, POLYMER & NUTRIFEED TROUGHS 471-764-001 - MOBILE BUND 14 000-765-014 CHEMSTORE SB II - LAB LIQUID WASTE MOBILE VESSEL (BUNDED) 441-001-031 - 5P MECHANICAL WORKSHOP SUMP 432-766-001
CIVIL
1Q QA AREA CHEMICAL STORE BUND 441-762-001 2L SOLVENT RECOVERY GROUND FLOOR 653-763-001 3F WWTP DECANTER BFP POLYMER TROUGH 471-764-002 - MOBILE BUND 15 000-765-015 CHEMSTORE SB II - LAB LIQUID WASTE MOBILE VESSEL (BUNDED) 441-001-032 - 5R DHS SKID SUMP 553-766-001 REGISTER OF BUNDS, CATCHMENT BASINS,
SUMPS & STORAGE AREAS
REVISION
SCALE 1:1000 SHEET DWG.
000-121018 SHEET 1 1
OF
DO NOT SCALE
SIZE A0 NO. 4
01 02 03 04 05 06 07 08 09 10
Noise Monitoring Report 2013
Condition 6.10 of IEL Register Number P0006-03 requires that:
'The licensee shall carry out a noise survey of the site operations annually. The survey
programme shall be undertaken in accordance with the methodology specified in the
Environmental Noise Survey Guidance Document as published by the Agency.'
Novartis Ringaskiddy Limited engaged the services of Dixon Brosnan Environmental

Consultants of Shronagreehy, Kealkill, Bantry, County Cork to undertake the survey.
The survey for 2013 was undertaken in line with the new EPA Guidance on noise surveys:
Guidance Note for Noise: Licence Applications, Surveys and Assessments in Relation to
Scheduled Activities (NG4).
The 2013 survey was undertaken during the daytime and night-time of Wednesday 19-Jun-2103
and Thursday 20-Jun-2013 at five monitoring points on the external perimeter of the facility:
Monitoring Point Location
1 West perimeter. This is a noise sensitive location located approximately

270 West of the nearest operational building at the facility, which houses
the main utility modules. This perimeter faces onto a ribbon development
of residential dwellings and a main road.
2 South perimeter. This perimeter faces onto a main road and an industrially
zoned area. The monitoring point is approximately 160 m south of the
company's main environmental control modules.
3 North East perimeter. This section of the perimeter also faces onto an
industrially zoned area and a secondary road. It is located approximately
270 m North East of the company's main environmental control modules.
4 North perimeter. This section of the perimeter faces onto an industrially

zoned area and a secondary road. It is located approximately 250 m north
of the company's main environmental control modules and approximately
190 m north of the company's solvent recovery facility.
5 North West perimeter. This section of the perimeter faces onto a
residential area (to the West) and an industrially zoned area (to the North).
A main road to the West and a secondary road to the North border it. The
monitoring point is approximately 660 m North West of the nearest
operational building at the facility, which houses the main utility modules.
Dixon Brosnans report is reproduced in full in the following pages; and the following is an
extract from the reports main findings:
Site specific noise levels throughout the daytime survey were significantly less than the 55 dB
daytime limit specified in IEL Register Number P0006-03 at all five monitoring stations. Night-
time levels were less than the 45 dB night-time limit. No audible impulsive or tonal emissions
were noted. Site emissions were continuous, steady and broadband in character.
Sound Level Monitoring Report 2013
DixonBrosnan
noise & ecology specialists
dixonbrosnan.com
Project
2013 annual environmental noise survey at
Novartis Ringaskiddy Ltd., Ringaskiddy, Co. Cork
Client
Environmental Laboratory Services Ltd.
Project no No pages Client reference DixonBrosnan 2013

1159 25 IPPC P0006-03 v140613
DixonBrosnan Shronagreehy Kealkil Bantry Co Cork

Tel 086 813 1195 | damian@dixonbrosnan.com | www.dixonbrosnan.com
Report no Date Edit Prepared by Chkd

1159.3.1 28.06.13 Release 1 Damian Brosnan CD
This report and its contents are copyright of DixonBrosnan. It may not be reproduced without permission. The report is
to be used only for its intended purpose. The report is confidential to the client, and is personal and non-assignable.
No liability is admitted to third parties. Do you really need a printed copy of this report?
Contents
1 Introduction 3
2 Results 3
3 Conclusions 4
Appendix 1: Monitoring stations 5
Appendix 2: P0006-03 noise conditions 6
Appendix 3: Survey details 7
Appendix 4: Noise data 11
Appendix 5: Frequency data 14
Appendix 6: Time history profiles & frequency spectra 17
Appendix 7: Glossary 25
Summary
This report describes the 2013 annual environmental noise survey carried out
by DixonBrosnan at Novartis Ringaskiddy Ltd. The survey is a requirement of
IPPC licence P0006-03. The survey consisted of daytime and night-time
monitoring undertaken 19.06.1321.06.13. It is understood that the facility was
operating normally throughout the survey.
Site specific noise levels throughout the daytime survey were significantly less
than the 55 dB daytime limit specified in IPPC licence P0006-03 at all five
monitoring stations. Night-time levels were less than the 45 dB night-time limit.
No audible impulsive or tonal emissions were noted. Site emissions were
continuous, steady and broadband in character.
___________________________________________________________________________________________
2013 annual environmental noise survey at Novartis Ringaskiddy Ltd., Ringaskiddy, Co. Cork DixonBrosnan report 1159.3
Client: Environmental Laboratory Services Ltd. 2
1 Introduction
1.1 DixonBrosnan noise consultants were instructed by Environmental Laboratory Services Ltd., on behalf of their
client Novartis Ringaskiddy Ltd. (NRL), to carry out the 2013 annual environmental noise survey in the vicinity of
the latters pharmaceutical facility at Ringaskiddy, Co. Cork. The objectives of the survey were as follows:
To measure noise levels at five monitoring stations (N1-N5) agreed previously with the Environmental Protection
Agency (stations shown in appendix 1).
To assess measured levels in the context of noise limits attached to IPPC licence P0006-03 issued by the
agency 02.02.06 in respect of the site (limits presented in appendix 2).
1.2 The noise survey was undertaken during daytime hours on Wednesday 19.06.13 and Thursday 20.06.13, and
night-time hours from 2300 on both dates. Survey methodology, equipment specifications and weather conditions
are listed in appendix 3. Intervals of 30 minutes were used at each station. Additional intervals of 15 minutes were
recorded at station N1 on the clients instructions.
1.3 The survey was carried out in accordance with Environmental Protection Agency document NG4 Guidance
note for noise: Licence applications, surveys and assessments in relation to scheduled activities (2012) and
International Standard ISO 1996-2 Acoustics Description, measurement and assessment of environmental
noise, Part 2: Determination of environmental noise levels (2007). As IPPC licence P0006-03 predates the NG4
document, evening monitoring was not required.
1.4 It is understood that the NRL facility was operating normally throughout the survey. Noise emissions arose
from various processing plant around the site, and from trucks onsite. Emissions also arose occasionally from
onsite construction plant. Offsite noise sources included traffic on local roads, aircraft and birdsong. At certain
locations, noise emissions were audible from other facilities in the vicinity.
2 Results
2.1 Noise data recorded are presented in appendix 4, and summarised in table 1 below. Tabulated frequency
data are presented in appendix 5. Frequency spectra and time history profiles are shown in appendix 6. LAF90 30
min data are generally representative of specific NRL noise levels due to their continuous and steady character,
and due to the influence of extraneous sources such as road traffic on measures LAeq 30 min levels.
___________________________________________________________________________________________
Table 1: Noise data summarised.
Station N1 N2 N3 N4 N5 N1 N2 N3 N4 N5
Period Day Day Day Day Day Night Night Night Night Night
Facility specific LAeq 30 min (dB) <41 42-44 40-46 41-46 <38 33-40 41-42 39-44 42-44 <26
Tone objectively detected x x x x x x x x x x
Tone attributable to facility x x x x x x x x x x
Facility audibly tonal x x x x x x x x x x
Facility audibly impulsive x x x x x x x x x x
Facility rated LReq 30 min (dB) <41 42-44 40-46 41-46 <38 33-40 41-42 39-44 42-44 <26
Limit (dB) 55 55 55 55 55 45 45 45 45 45
Compliance
2.2 Daytime specific noise levels attributable to the NRL facility were highest at stations N3 and N4, approaching
46 dB at both. Levels approached 44 dB at N2. Levels were noticeably lower at the more distant stations N1 and
N5. A similar pattern was evident during the night-time, with levels approaching 44 dB at N3 and N4, and 42 dB at
N2. Levels were again lower at N1 and N5 at night. In all cases, site specific noise levels were lower than the
daytime 55 dB and night-time 45 dB limits included in IPPC licence P0006-03.
2.3 NRL noise consisted chiefly of continuous steady broadband emissions arising from onsite processes. At
times, emissions from truck and construction plant movements onsite were slightly audible, generally at levels
insufficient to affect measured data. NRL emissions were not audibly or objectively tonal, and did not contain
impulsive elements. Data presented in appendices 5 and 6 confirm the absence of tones.
3 Conclusions
3.1 At all five monitoring stations, specific NRL noise levels throughout the daytime survey were significantly less
than the 55 dB daytime limit specified in IPPC licence P0006-03. Night-time levels were less than the 45 dB night-
time limit.
3.2 No audible impulsive or tonal emissions were noted. NRL emissions were continuous, steady and broadband
in character.
___________________________________________________________________________________________
Appendix 1: Noise stations
Station ITM NGR Location Propagation route terrain

N1 576114 563594 SW boundary of site, 5 m from residential Semi-mature deciduous trees and
boundary, approx. 270 m W of nearest NRL lagoon area, low mound (planted) along
building route
N2 576824 563674 Immediately outside SE corner of site operations Grassed, with planted boundary, level
area terrain
N3 576883 563946 NE corner of field on E boundary of site, approx. Young cereal crop, slightly rising terrain
270 m NE of NRL environmental control modules
N4 576683 563988 Emergency gate at NE corner of site operations Semi-mature deciduous trees, with gap
area on access
N5 575879 564055 Adjacent to road junction to NW of site, approx. Parkland, level terrain
660 m NW of nearest NRL building
N3
N2
N4
N1
N5
___________________________________________________________________________________________
Appendix 2: P0006-03 noise conditions
Note: 5 monitoring stations have been agreed with the EPA, as shown in appendix 1.
___________________________________________________________________________________________
Appendix 3: Survey details
File Project ref. 1159
Client ELS on behalf of Novartis
Location Novartis Ringaskiddy
Stations N1 N2 N3 N4 N5
Purpose 2013 annual IPPC licence compliance survey
Comment Facility operating DAYTIME SURVEY ROUNDS 1 & 2
Event Period Daytime
Date 19.06.13
Day Wednesday
Time 1000-1730
Operator Damian Brosnan BSc MIOA MIEI
Conditions Cloud cover 30-50 %
Precipitation 0 mm
Temperature 14 rising to 22 0C
Wind Direction NW
Speed 0-2 m/s
Measurement Anemo anemometer 2 m above ground level
Sound level meter Instrument Bruel & Kjaer Type 2250
Instrument serial no. 2506594
Microphone serial no. 2529531
Application BZ7224 Version 2.5
Bandwidth Broadband & 1/3 octaves
Max input level 141.16 dB
Broadband weightings Time: Fast Frequency: AC
Spectrum weightings Time: Fast Frequency: Z
Windscreen correction UA-1650
Sound field correction Free-field
UKAS calibration 17.01.12
Calibrating laboratory Bruel & Kjaer Denmark
Calibration certificate Available on request
Onsite calibration Time 19/06/2013 09:56:52
Calibration type External
Sensitivity 47.74 mV/Pa
Post measurement check 93.9 dB
Onsite calibrator Instrument Bruel & Kjaer Type 4231
Methodology Standards ISO 1996 Part 1 (2003) & Part 2 (2007) EPA NG4 (2012)
Exceptions -
Intervals 30 min + 15 min at N1
___________________________________________________________________________________________
Comment Facility operating DAYTIME SURVEY ROUND 3
Event Period Daytime
Date 20.06.13
Day Thursday
Time 1215-1545
Conditions Cloud cover Increasing to 100 % by 1300
Precipitation 0 mm
Temperature 17 0C
Wind Direction SE
Speed 0-2 m/s
Exceptions -
___________________________________________________________________________________________
Comment Facility operating NIGHT-TIME SURVEY ROUND 1
Event Period Night-time
Date 19.06.1320.06.13
Day Wednesday night to Thursday morning
Time 2300-0230
Conditions Cloud cover 0%
Precipitation 0 mm
Temperature 13 0C
Wind Direction -
Speed 0 m/s
Exceptions -
___________________________________________________________________________________________
Comment Facility operating NIGHT-TIME SURVEY ROUND 2
Event Period Night-time
Date 20.06.1321.06.13
Day Thursday night to Friday morning
Time 2300-0230
Conditions Cloud cover 90 %
Precipitation 0 mm
Temperature 16 falling to 14 0C
Wind Direction NW
Speed 0-2 m/s
Exceptions -
___________________________________________________________________________________________
Appendix 4: Noise data
Daytime levels
Station Time LAeq 30 min LAF10 30 min LAF90 30 min Specific Noise audible
dB dB dB level* dB
N1 1244-1314 43 43 38 38 Novartis broadband emissions
continuously slightly audible, not
19.06.13
significant. Public road traffic
intermittently audible at low level to W.
Voices from sporadic pedestrians
passing nearby dominant when present.
Occasional voices and activity audible in
domestic garden 80 m SW. Intermittent
gun shots or bird scaring devices clearly
1314-1329 43 44 38 38 audible several hundred metres to W.
Lightly rustling vegetation. Aircraft. Local
19.06.13
birdsong occasionally significant.
1558-1628 45 47 41 <41 Generally as above. Construction plant
slightly audible at Novartis facility.
19.06.13
Repeated dog barking 2-300 m NW
1628-1643 46 48 41 <41 audible at low level. Chainsaw
occasionally audible in distance to S.
19.06.13
1408-1438 46 46 37 37 Novartis emissions continuously audible
at low level. Occasional truck or plant
20.06.13
movements slightly audible onsite.
1438-1453 43 44 38 38 Extraneous noise audible from road to
W. Birdsong, aircraft, and bird scarer
20.06.13
device or gunshots audible several
hundred metres to W.
N2 1008-1038 52 55 44 44 Novartis emissions continuously clearly
audible, broadband and not significant.
19.06.13
Sporadic truck movements slightly
audible onsite. Intermittent R613 traffic
dominant when present. Bird song/calls
and aircraft.
1408-1438 54 58 43 43 As above.
19.06.13
1217-1247 56 60 42 42 Continuous Novartis emissions audible
at low level. Additional onsite noise
20.06.13
arising occasionally from truck
movements and construction activity
inside SE corner. Intermittent R613
traffic dominant when present. Hiss from
nearby gas installation faintly audible.
Bird song/calls and aircraft.
19.06.13
Continuous emissions from Janssen to
N also clearly audible. Occasional local
road traffic dominant when present.
Intermittent R613 traffic to S faintly
audible when present. Bird song/calls
and aircraft.
*Specific level: Sound pressure level contribution considered attributable to facility, determined using real time assessment,
field notes, time history profiles, statistical analysis, frequency spectra, near field correction if applicable, and other parameters.
NOTE: Parameters presented re additional 15 min intervals (shaded rows above, measured at N1 on clients instructions)
are LAeq 15 min, LAF10 15 min and LAF90 15 min.
___________________________________________________________________________________________
Daytime levels continued
dB dB dB level* dB
N3 1446-1516 45 45 41 40 As previous measurement.
19.06.13
1256-1326 48 50 46 46 Novartis broadband emissions
continuously clearly audible. No other
20.06.13
noise auidble apart from sporadic local
road traffic, intermittent R613 traffic
noise to S audible at low level, and local
birdsong. Janssen emissions inaudible.
N4 1120-1150 48 50 43 42 Novartis broadband emissions
continuously clearly audible. Janssen
19.06.13
emissions also clearly audible at slightly
lower level. Occasional truck
movements at Novartis site slightly
audible. Sporadic passing traffic on
public road dominant when present. N25
traffic to N slightly audible continuously.
Bird song/calls, aircraft and lightly
rustling trees.
1519-1549 47 51 42 41 As above, minus rustling trees. Mobile
plant audible at low level at Novartis site
19.06.13
1530-1531.
1330-1400 51 51 46 46 Novartis broadband emissions
continuously clearly audible and
20.06.13
dominant. Occasional truck and forklift
truck movements audible onsite.
Sporadic local traffic dominant when
present. Road traffic to SE frequently
slightly audible. Birdsong. Voices from
road bowling group at 20 m significant
from start of interval to 1340.
N5 1155-1225 53 58 35 <35 No Novartis emissions audible.
Strimmer in use at adjacent premises
19.06.13
continuously audible and dominant until
1205. No other emissions audible while
strimmer in use, apart from intermittent
road traffic through nearby road junction
and occasional traffic passing N5.
Following strimmer shut off at 1205,
extraneous sources becoming audible:
bird song/calls, aircraft and distant
traffic. Novartis still inaudible.
Intermittent gun shots or bird scaring
devices clearly audible several hundred
metres SW.
1651-1721 50 50 35 <35 As above, minus strimmer. Local road
traffic increased.
19.06.13
1501-1531 50 49 38 <38 Novartis emissions slightly audible
continuously. Intermittent road traffic
20.06.13
through local junction dominant when
present, particularly sporadic traffic
using side road. Bird song/calls and
aircraft. Lightly rustling vegetation.
___________________________________________________________________________________________
Night-time levels
dB dB dB level* dB
N1 2308-2338 41 41 40 40 Novartis emissions audible at low level
continuously, broadband and not
19.06.13
significant. Occasional traffic clearly
2338-2353 42 43 41 40 audible on road to W. Distant traffic
almost continuously slightly audible. Bird
19.06.13
calls and dog barking audible in
surrounding area. Aircraft.
0137-0207 34 36 33 33 Novartis emissions continuously audible
at low level, predominant due to
21.06.13
absence of other sources. Only other
0207-0222 36 37 34 34 noise: sporadic traffic on road to W, and
distant dog barking.
21.06.13
N2 0008-0038 46 44 42 42 Novartis continuous emissions clearly
audible, and masking all extraneous
20.06.13
sources other than sporadic R613 traffic,
and faintly audible hiss from nearby gas
installation.
0052-0122 50 43 41 41 Novartis emissions continuously
dominant. Hiss at nearby gas installation
21.06.13
also faintly audible. No other noise
audible apart from passing vehicles on
road x2 at end of interval.
audible and dominant, broadband. No
20.06.13
other noise audible apart from sporadic
traffic on R613.
0017-0047 42 43 41 39 Novartis emissions continuously clearly
audible. Janssen emissions also
21.06.13
continuously audible, and only
marginally lower than Novartis
emissions. Occasional traffic slightly
audible on R613.
audible and dominant. No other noise
20.06.13
audible.
2338-0008 43 44 42 42 Novartis emissions continuously clearly
audible. Janssen emissions also
20.06.13
continuously slightly audible. No other
noise audible, apart from passing car x1.
N5 0155-0225 31 29 25 25 Novartis emissions continuously slightly
20.06.13
Distant road traffic faintly audible
continuously. Voices nearby during first
min. Distant dog barking audible.
Vehicle movement x1 through nearby
junction.
2301-2331 39 41 26 <26 No facility emissions audible.
Occasional road traffic through nearby
20.06.13
junction dominant when present. Distant
traffic to W and NW continuously slightly
audible. Lightly rustling vegetation.
Occasional dog barking in distance
audible. Aircraft.
NOTE: Parameters presented re additional 15 min intervals (shaded rows above, measured at N1 on clients instructions)
are LAeq 15 min, LAF10 15 min and LAF90 15 min.
___________________________________________________________________________________________
Appendix 5: Frequency data
Level differences suggested by annex D of International Standard ISO 1996-2 Acoustics Description,
measurement and assessment of environmental noise, Part 2: Determination of environmental noise levels (2007):
15 dB in the third octave bands 25-125 Hz.

Level differences in the 10-160 Hz range which exceed the above criteria will not be of tonal significance if LZeq
values in those bands are lower than hearing threshold levels as follows:
Band (Hz) 10 12.5 16 20 25 31.5 40 50 63 80 100 125 160

LZeq (dB) 92 87 83 74 64 56 49 43 42 40 38 36 34
As NRL emissions were generally continuous and steady, and therefore best represented by the LAF90 30 min
parameter in most cases, it follows that LZF90 30 min spectra are more appropriate than LZeq 30 min spectra. LZF90 30 min
spectra are shown in appendix 6. Tabulated values are shown over. No tones were detected in LZF90 30 min spectra.
While some energy was detected in the 125 Hz band at stations N3 and N4 during both night-time surveys, most
likely attributable to NRL emissions, this energy was not objectively or audibly tonal.
___________________________________________________________________________________________
Band N1 (dB) N2 (dB) N3 (dB)
Daytime Night-time Daytime Night-time Daytime Night-time
(Hz)
1/3 2/3 3/3 1/2 2/2 1/3 2/3 3/3 1/2 2/2 1/3 2/3 3/3 1/2 2/2
LZF90 LZF90 LZF90 LZF90 LZF90 LZF90 LZF90 LZF90 LZF90 LZF90 LZF90 LZF90 LZF90 LZF90 LZF90
6.30 42 52 42 39 39 61 51 54 40 47 44 43 56 40 57
8 44 50 43 42 41 60 50 53 43 46 45 44 55 44 55
10 46 50 45 45 44 58 49 53 45 46 45 44 53 46 54
12.50 52 52 50 47 46 56 50 52 48 47 49 48 51 48 52
16 46 48 46 46 44 54 49 50 46 46 47 46 50 46 49
20 51 51 48 49 46 53 51 51 48 48 49 49 50 48 50
25 47 49 48 48 46 52 50 50 47 47 50 47 49 47 47
31.50 47 48 47 47 44 52 51 50 45 46 49 46 49 45 48
40 49 49 48 50 47 50 50 50 47 47 51 47 51 47 50
50 50 49 47 50 47 54 54 54 53 50 50 47 55 46 50
63 48 47 44 47 44 51 50 50 48 46 47 45 50 43 45
80 46 45 42 47 44 52 51 50 50 48 46 44 46 43 40
100 43 41 39 43 40 48 47 47 46 44 43 42 44 40 38
125 39 35 32 41 37 44 44 47 43 42 42 45 45 45 44
160 36 28 24 41 35 42 42 42 41 37 37 39 40 38 36
200 29 26 24 43 33 36 35 35 33 31 33 33 34 34 32
250 26 26 24 36 27 32 31 31 30 30 32 32 31 33 33
315 29 28 26 34 25 34 33 31 34 33 32 30 30 33 35
400 30 30 30 31 24 34 33 34 34 34 31 31 31 32 34
500 31 31 28 29 22 36 33 32 33 33 31 32 33 33 31
630 29 32 28 30 21 36 33 31 33 33 30 30 35 35 30
800 28 32 27 30 21 35 34 32 33 32 30 30 38 36 31
1000 27 32 27 27 19 33 32 31 30 31 31 30 38 35 31
1250 24 29 24 24 17 32 32 30 33 28 30 29 36 34 29
1600 21 25 22 20 14 32 31 28 29 26 29 28 34 31 27
2000 19 23 20 16 12 31 28 26 26 25 29 27 35 31 26
2500 19 21 17 13 12 28 24 23 22 23 30 25 31 29 23
3150 15 19 15 10 9 27 20 20 19 19 29 24 30 28 23
4000 14 17 13 8 8 23 16 17 14 16 26 23 28 25 21
5000 13 15 10 7 7 19 13 15 11 14 24 20 25 23 20
6300 12 13 9 7 7 16 11 12 8 10 20 16 21 18 16
8000 11 11 8 7 7 14 9 10 7 8 15 12 16 12 13
10000 9 10 7 7 7 11 9 9 7 7 10 9 11 8 10
12500 9 9 7 7 7 10 8 8 7 7 8 9 8 7 8
16000 8 9 7 7 7 9 8 8 7 7 7 8 7 7 8
20000 8 8 8 7 7 8 8 8 7 7 7 8 7 7 7
A 38 41 37 40 33 44 43 42 42 41 42 41 46 44 41
___________________________________________________________________________________________
Band N4 (dB) N5 (dB)
Daytime Night-time Daytime Night-time
(Hz)
1/3 2/3 3/3 1/2 2/2 1/3 2/3 3/3 1/2 2/2
LZF90 LZF90 LZF90 LZF90 LZF90 LZF90 LZF90 LZF90 LZF90 LZF90
6.30 50 44 48 42 44 43 42 43 38 36
8 50 45 48 45 45 43 42 43 41 38
10 49 46 49 47 46 44 43 45 43 39
12.50 50 49 50 49 48 46 47 50 45 43
16 49 48 50 48 47 44 45 47 42 40
20 49 49 50 49 48 45 46 49 46 43
25 49 48 49 49 47 43 44 46 42 36
31.50 48 47 50 48 46 43 45 44 41 38
40 50 48 50 49 48 43 45 44 41 38
50 50 50 51 48 49 42 44 43 41 37
63 46 46 47 45 43 40 42 39 34 33
80 45 44 47 45 43 39 38 37 30 28
100 43 43 45 44 42 32 35 34 27 24
125 42 47 47 47 48 28 31 33 25 21
160 39 41 42 41 41 25 28 31 23 19
200 32 33 36 34 32 26 27 30 22 19
250 30 30 33 32 29 24 25 28 20 19
315 30 31 34 33 30 24 24 27 20 19
400 31 30 36 35 31 24 25 31 17 18
500 32 31 36 34 31 24 25 29 16 17
630 33 31 37 35 31 25 25 27 14 16
800 33 32 37 34 32 25 26 27 13 18
1000 32 31 35 32 31 25 27 27 12 18
1250 30 29 34 30 28 23 24 24 10 15
1600 30 29 35 28 28 21 22 23 8 11
2000 30 30 35 29 30 20 19 21 6 8
2500 29 26 29 27 26 19 17 20 5 7
3150 25 24 28 25 23 18 15 18 5 6
4000 23 20 26 23 20 16 14 16 5 7
5000 20 17 22 19 17 14 13 14 6 7
6300 18 14 18 16 14 13 13 12 7 7
8000 15 11 14 13 11 11 12 11 7 7
10000 13 10 14 12 12 9 9 9 7 7
12500 10 8 8 7 8 9 8 8 7 7
16000 9 8 8 7 7 8 8 8 7 7
20000 8 8 8 7 7 8 8 8 7 7
A 43 42 46 43 42 35 35 38 25 26
___________________________________________________________________________________________
Appendix 6: Time history profiles & frequency spectra
___________________________________________________________________________________________
___________________________________________________________________________________________
___________________________________________________________________________________________
___________________________________________________________________________________________
___________________________________________________________________________________________
___________________________________________________________________________________________
___________________________________________________________________________________________
___________________________________________________________________________________________
Appendix 7: Glossary
Ambient Total noise environment at a location, including all sounds present.
A-weighting Weighting or adjustment applied to sound level to approximate non-linear frequency response of human
ear. Denoted by suffix A in parameters such as LAeq T, LAF10 T, etc.
Background level LAF90 T. A-weighted sound pressure level of residual noise exceeded for 90 % of time interval T.
Broadband Noise which contains roughly equal energy across frequency spectrum. Does not contain tones, and is
generally less annoying than tonal noise.
Decibel Shortened to dB. Unit of noise measurement scale. Based on logarithmic scale so cannot be simply
added or subtracted. 3 dB difference is smallest change perceptible to human ear. 10 dB difference is
perceived as doubling or halving of sound level. Throughout this report noise levels are presented as
decibels relative to 20 Pa. Examples of decibel levels are as follows: 20 dB: very quiet room; 30-35
dB: night-time rural environment; 55-65 dB: conversation; 80 dB: busy pub; 100 dB: nightclub.
Fast response 0.125 seconds response time of sound level meter to changing noise levels. Denoted by suffix F in
parameters such as LAF10 T, LAF90 T, etc.
Frequency Number of cycles per second of a sound or vibration wave. Low frequency noise may be perceived as
hum, while whine represents higher frequency. Range of human hearing approaches 20-20,000 Hertz.
Hertz Shortened to Hz. Unit of frequency measurement.
Impulse Noise which is of short duration, typically less than one second, sound pressure level of which is
significantly higher than background.
Interval Time period T over which noise monitoring is conducted. Denoted by T in LAeq T, LAF90 T, etc.
LAeq T Equivalent continuous sound level during interval T, effectively representing average A-weighted noise
level.
LAF Sound pressure level averaged over one second, and changing each second in fluctuating noise
environment.
LAF10 T Sound pressure level exceeded for 10% of interval T, usually used to quantify traffic noise.
LAF90 T Sound pressure level exceeded for 90% of interval T, usually used to quantify background noise. May
also be used to describe noise level from continuous steady or almost-steady source, particularly where
local noise environment fluctuates.
LReq T Rating noise level, derived from LAeq T plus specified adjustments for tonal and impulsive characteristics.
Equivalent to LAr T used by EPA.
Noise sensitive location Any dwelling house, hotel or hostel, health building, educational establishment, place of worship or
entertainment, or any other facility or area of high amenity which for its proper enjoyment requires
absence of noise at nuisance levels.
1/3 octave band Frequency spectrum may be divided into octave bands. Upper limit of each octave is twice lower limit.
Each octave may be subdivided into thirds, allowing greater analysis of tones.
Residual level Noise level remaining when specific source is absent or does not contribute to ambient.
Specific level Sound pressure level contribution arising from specific noise source, measured directly or by estimation
or calculation.
Tone Character of noise caused by dominance of one or more frequencies which may result in increased noise
nuisance.
Z-weighting Standard weighting applied by sound level meters to represent linear scale. Denoted by suffix Z in
parameters such as LZeq T, LZF90 T, etc. used to describe 1/3 octave band levels in frequency spectra.
In this report units are generally presented using US National Institute Of Standards & Technology guidelines.
___________________________________________________________________________________________
Groundwater Monitoring Summary 2013
Further to Schedule C.6 of IEL Register Number P0006-03, Novartis Ringaskiddy Limited
wishes to present monitoring data for all parameters on groundwater sampled from the four
monitoring wells specified in Schedule C.6 of the aforementioned licence.
Attachment I contains a copy of a report on groundwater quality of four samples taken from
Monitoring Well Numbers MW1, MW2, MW3 and Artesian Well AW6 on 31-Oct-2013.
Attachment II contains a copy of a report on groundwater quality of four samples taken from
Monitoring Well Numbers MW1, MW2, MW3 and Artesian Well AW6 on 05-Dec-2013.
It was not possible to undertake a round of sampling during the first-half of the year due to
operational difficulties at the companys Wastewater Treatment Plant, details of which are
described in Section 2 of this AER>
Note that both reports also contain an analysis on an additional monitoring well Monitoring
Well 6, which was installed at the Wastewater Treatment Plant in recent years. This well is not
specifically covered under the requirements of IEL Register Number P0006-03 and was
installed as a risk reduction measure arising from implementation of the Environmental Liability
Risk Assessment process at the facility.
Attachment III contains a copy of Drawing Number 000-121007 (Rev 1) Civil Location of
Groundwater Monitoring Wells
The results indicate that the quality of the groundwater under the site at Novartis Ringaskiddy
Limited has remained the same as that prior to the commencement of the development at
Novartis Ringaskiddy Limited.
ATTACHMENT I
ENVIRONMENTAL
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Tel No 021- 4862324 Received or Collected ELS-Sampled

Quotation No QN001791 Sample Type Ground Waters
Customer Ref AW6
Ammonia
Ammonia (as N) EW154M-1 0.007 0.087 mg/l N INAB
Ammonium (as NH4)(Calc) EW154M-1 0.009 0.112 mg/l NH4 INAB
AQ2-UP1
Nitrate (as N) EW154M-1 0.12 <0.12 mg/l N INAB
Nitrate (as NO3)(Calc) EW154M-1 0.53 <0.53 mg/l NO3 INAB
Nitrite (as N) EW154M-1 0.013 <0.013 mg/l N INAB
Nitrite (as NO2)(Calc) EW154M-1 0.043 <0.043 mg/l NO2 INAB
Phosphate-Ortho(as P) EW154M-1 0.009 <0.009 mg/l P INAB
Phosphate-Ortho (as PO4) EW154M-1 0.028 <0.028 mg/l PO4
AQ2-UP2
Chloride EW154M-1 2.6 13.7 mg/L INAB
Sulphate EW154M-1 1.0 9.7 mg/L INAB
COD
COD EW094 8 <8 mg/L INAB
GCFID-Organic Solvents (Liquid Injection)
Acetic Acid EO089 0.1 <0.1 mg/L
Acetonitrile EO089 0.1 <0.1 mg/L
Cyclohexane EO089 0.1 <0.1 mg/L
Ethanol EO089 0.1 <0.1 mg/L
Ethyl Acetate EO089 0.1 0.5 mg/L
Heptane EO089 0.1 <0.1 mg/L
IPA (2-Propanol) EO089 0.1 <0.1 mg/L
Isopropyl Acetate EO089 0.1 <0.1 mg/L
Isopropyl Ether EO089 0.1 <0.1 mg/L
Methanol EO089 0.1 <0.1 mg/L
N,N-Dimethylformamide EO089 0.1 <0.1 mg/L
n-Butyl Alcohol.(Butanol) EO089 0.1 <0.1 mg/L
n-Hexane EO089 0.1 <0.1 mg/L
sec-Butyl Alcohol EO089 0.1 <0.1 mg/L
Triethylamine EO089 0.1 <0.1 mg/L
GW Levels (Site)
Ground Water Level Default 0.0 20.1 m
Borehole Depth Default 0.0 50.0 m
GW Depth (Calc) Default 0.0 29.9 m
Metals-Dissolved
Signed : 25/11/2013

NOTES
Page 1 of 20
ENVIRONMENTAL
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Ireland
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Customer Ref AW6
Metals-Dissolved
Iron-Dissolved EM130 20.0 <20.0 ug/L INAB
Manganese-Dissolved EM130 1.0 7.2 ug/L INAB
Aluminium-Dissolved EM130 5.0 14.9 ug/L INAB
Cadmium-Dissolved EM130 0.1 <0.1 ug/L INAB
Calcium-Dissolved EM130 1.0 38.6 mg/L INAB
Chromium-Dissolved EM130 1.0 1.1 ug/L INAB
Copper-Dissolved EM130 0.003 0.003 mg/L INAB
Lead-Dissolved EM130 0.3 <0.3 ug/L INAB
Magnesium-Dissolved EM130 0.3 1.3 mg/L INAB
Nickel-Dissolved EM130 0.5 1.0 ug/L INAB
Zinc-Dissolved EM130 1.0 5.5 ug/L INAB
Mercury-Dissolved EM130 0.02 <0.02 ug/L INAB
Titralab
pH EW153 0.0 7.8 pH Units INAB
Conductivity @20 DegC EW153 25 227 uscm-1@20 INAB
Alkalinity Total (R2 pH4.5) EW153 10 100 mg/L CaCO3 INAB
Alkalinity Carbonate (R1 pH8.3) EW153 10 <10 mg/L CaCO3
Alkalinity Bicarbonate(Calc) EW153 10 100 mg/L CaCO3
Total Organic Carbon (TOC)
Total Organic Carbon (TOC) EW123 0.25 2.55 mg/L INAB
VOC Full Suite
Dichlorodifluoromethane EO025 10.0 <10.0 ug/L
Chloromethane EO025 0.5 <0.5 ug/L
Ethyl Chloride/Chloroethane EO025 0.5 <0.5 ug/L
Vinyl Chloride EO025 0.5 <0.5 ug/L
Bromomethane EO025 0.5 <0.5 ug/L INAB
Trichloromonofluoromethane EO025 0.5 <0.5 ug/L
Ethyl Ether/Diethyl Ether EO025 0.5 <0.5 ug/L INAB
11 Dichloroethene EO025 0.5 <0.5 ug/L INAB
Acetone EO025 2.0 <2.0 ug/L
Iodomethane/Methyl Iodide EO025 0.5 <0.5 ug/L INAB
Carbon Disulphide EO025 0.5 <0.5 ug/L INAB
Allyl Chloride EO025 0.5 <0.5 ug/L INAB
Dichloromethane EO025 5.0 <5.0 ug/L INAB
Chlormethyl Cyanide/Chloroacetonitrile EO025 0.5 <0.5 ug/L INAB
Nitrobenzene EO025 0.5 <0.5 ug/L
Signed : 25/11/2013

NOTES
Page 2 of 20
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Customer Ref AW6
VOC Full Suite
Propanenitrile EO025 10 <10 ug/L
Hexachlorobutadiene EO025 0.5 <0.5 ug/L INAB
Trans-1,2 Dichloroethene EO025 0.5 <0.5 ug/L INAB
MtBE EO025 0.5 <0.5 ug/L INAB
1,1-dichloroethane EO025 0.5 <0.5 ug/L INAB
2,2-dichloropropane EO025 0.5 <0.5 ug/L INAB
cis-12 Dichloroethene EO025 0.5 <0.5 ug/L INAB
2-Butanone EO025 5.0 <5.0 ug/L
Methyl Acrylate EO025 0.5 <0.5 ug/L INAB
Bromochloromethane EO025 0.5 <0.5 ug/L INAB
Methacrylonitrile EO025 5.0 <5.0 ug/L
Tetrahydrofuran EO025 0.5 <0.5 ug/L INAB
Chloroform EO025 1.0 <1.0 ug/L INAB
1,1,1-trichloroethane EO025 0.5 <0.5 ug/L INAB
1-Chlorobutane EO025 0.5 <0.5 ug/L INAB
Carbon Tetrachloride EO025 0.5 <0.5 ug/L INAB
11 Dichloropropene EO025 0.5 <0.5 ug/L INAB
Benzene EO025 0.1 <0.1 ug/L INAB
1,2 dicloroethane EO025 0.1 <0.1 ug/L INAB
Trichloroethene EO025 0.1 <0.1 ug/L INAB
Dibromomethane EO025 0.5 <0.5 ug/L INAB
Methyl Methacrylate EO025 0.5 <0.5 ug/L INAB
Bromodichloromethane EO025 2.0 <2.0 ug/L INAB
13 Dichloropropene,cis EO025 2.0 <2.0 ug/L INAB
MIBK/4 Methyl 2 Pentanone EO025 2.0 <2.0 ug/L INAB
Toluene EO025 0.5 <0.5 ug/L
Analyst QC Comment QC:Due to quality failure during this test run the following result is indicative.
13 Dichloropropene,trans EO025 2.0 <2.0 ug/L INAB
Ethyl Methacrylate EO025 2.0 <2.0 ug/L INAB
112 Trichloroethane EO025 0.5 <0.5 ug/L INAB
Tetrachloroethene EO025 0.1 <0.1 ug/L INAB
2-Hexanone EO025 1.0 <1.0 ug/L INAB
Dibromochloromethane EO025 1.0 <1.0 ug/L INAB
1,2-dibromoethane EO025 0.5 <0.5 ug/L INAB
Chlorobenzene EO025 0.5 <0.5 ug/L INAB
Signed : 25/11/2013

NOTES
Page 3 of 20
ENVIRONMENTAL
LABORATORY SERVICES
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Cork
Ireland
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Fax: +353 21 453 6149


Customer Ref AW6
VOC Full Suite
1,1,1,2-tetrachloroethane EO025 2.0 <2.0 ug/L INAB
Ethylbenzene EO025 0.5 <0.5 ug/L INAB
Xylene P&M EO025 0.5 <0.5 ug/L INAB
Xylene -o EO025 0.5 <0.5 ug/L INAB
Styrene EO025 2.0 <2.0 ug/L INAB
Bromoform EO025 1.0 <1.0 ug/L INAB
Isopropylbenzene EO025 0.5 <0.5 ug/L INAB
Bromobenzene EO025 0.5 <0.5 ug/L INAB
1,2,3-trichloropropane EO025 2.0 <2.0 ug/L INAB
Trans 14 Dichloro 2 Butene, tran EO025 2.0 <2.0 ug/L
Propylbenzene EO025 0.5 <0.5 ug/L INAB
2-chlorotoluene EO025 0.5 <0.5 ug/L INAB
1,3,5-trimethylbenzene EO025 0.5 <0.5 ug/L INAB
Tert Butyl Benzene EO025 0.5 <0.5 ug/L INAB
sec-butylbenzene EO025 0.5 <0.5 ug/L INAB
1,3-dichlorobenzene EO025 0.5 <0.5 ug/L INAB
P Isopropyltoluene EO025 0.5 <0.5 ug/L INAB
N Butyl Benzene EO025 0.5 <0.5 ug/L INAB
Hexachloroethane EO025 5.0 <5.0 ug/L INAB
1,2-dibromo-3-chloropropane EO025 2.0 <2.0 ug/L INAB
1,2,4-trichlorobenzene EO025 0.5 <0.5 ug/L INAB
Naphthalene EO025 2.0 <2.0 ug/L
Signed : 25/11/2013

NOTES
Page 4 of 20
ENVIRONMENTAL
LABORATORY SERVICES
Blackrock,
Cork
Ireland
Tel: +353 21 453 6141
Fax: +353 21 453 6149


Customer Ref MW6
Ammonia
AQ2-UP1
Nitrate (as N) EW154M-1 0.12 1.10 mg/l N INAB
Nitrate (as NO3)(Calc) EW154M-1 0.53 4.86 mg/l NO3 INAB
AQ2-UP2
COD
GW Levels (Site)
Metals-Dissolved
Iron-Dissolved EM130 20.0 28.6 ug/L INAB
Signed : 25/11/2013

NOTES
Page 5 of 20
ENVIRONMENTAL
LABORATORY SERVICES
Blackrock,
Cork
Ireland
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Customer Ref MW6
Metals-Dissolved
Copper-Dissolved EM130 0.003 <0.003 mg/L INAB
Titralab
VOC Full Suite
Signed : 25/11/2013

NOTES
Page 6 of 20
ENVIRONMENTAL
LABORATORY SERVICES
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Cork
Ireland
Tel: +353 21 453 6141
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Customer Ref MW6
VOC Full Suite
Tetrahydrofuran EO025 0.5 17.5 ug/L INAB
Signed : 25/11/2013

NOTES
Page 7 of 20
ENVIRONMENTAL
LABORATORY SERVICES
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Cork
Ireland
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Customer Ref MW6
VOC Full Suite
Signed : 25/11/2013

NOTES
Page 8 of 20
ENVIRONMENTAL
LABORATORY SERVICES
Blackrock,
Cork
Ireland
Tel: +353 21 453 6141
Fax: +353 21 453 6149


Customer Ref MW1
Ammonia
AQ2-UP1
AQ2-UP2
COD
COD EW094 8 27 mg/L INAB
GW Levels (Site)
Metals-Dissolved
Signed : 25/11/2013

NOTES
Page 9 of 20
ENVIRONMENTAL
LABORATORY SERVICES
Blackrock,
Cork
Ireland
Tel: +353 21 453 6141
Fax: +353 21 453 6149


Customer Ref MW1
Metals-Dissolved
Copper-Dissolved EM130 0.003 0.005 mg/L INAB
Titralab
VOC Full Suite
Signed : 25/11/2013

NOTES
Page 10 of 20
ENVIRONMENTAL
LABORATORY SERVICES
Blackrock,
Cork
Ireland
Tel: +353 21 453 6141
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Customer Ref MW1
VOC Full Suite
Signed : 25/11/2013

NOTES
Page 11 of 20
ENVIRONMENTAL
LABORATORY SERVICES
Blackrock,
Cork
Ireland
Tel: +353 21 453 6141
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Customer Ref MW1
VOC Full Suite
Signed : 25/11/2013

NOTES
Page 12 of 20
ENVIRONMENTAL
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Customer Ref MW2
Ammonia
AQ2-UP1
AQ2-UP2
COD
GW Levels (Site)
Metals-Dissolved
Signed : 25/11/2013

NOTES
Page 13 of 20
ENVIRONMENTAL
LABORATORY SERVICES
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Cork
Ireland
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Fax: +353 21 453 6149


Customer Ref MW2
Metals-Dissolved
Chromium-Dissolved EM130 1.0 <1.0 ug/L INAB
Lead-Dissolved EM130 0.3 0.5 ug/L INAB
Titralab
VOC Full Suite
Signed : 25/11/2013

NOTES
Page 14 of 20
ENVIRONMENTAL
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Tel: +353 21 453 6141
Fax: +353 21 453 6149


Customer Ref MW2
VOC Full Suite
Signed : 25/11/2013

NOTES
Page 15 of 20
ENVIRONMENTAL
LABORATORY SERVICES
Blackrock,
Cork
Ireland
Tel: +353 21 453 6141
Fax: +353 21 453 6149


Customer Ref MW2
VOC Full Suite
Signed : 25/11/2013

NOTES
Page 16 of 20
ENVIRONMENTAL
LABORATORY SERVICES
Blackrock,
Cork
Ireland
Tel: +353 21 453 6141
Fax: +353 21 453 6149


Customer Ref MW3
Ammonia
AQ2-UP1
AQ2-UP2
COD
GW Levels (Site)
Metals-Dissolved
Signed : 25/11/2013

NOTES
Page 17 of 20
ENVIRONMENTAL
LABORATORY SERVICES
Blackrock,
Cork
Ireland
Tel: +353 21 453 6141
Fax: +353 21 453 6149


Customer Ref MW3
Metals-Dissolved
Aluminium-Dissolved EM130 5.0 <5.0 ug/L INAB
Titralab
VOC Full Suite
Signed : 25/11/2013

NOTES
Page 18 of 20
ENVIRONMENTAL
LABORATORY SERVICES
Blackrock,
Cork
Ireland
Tel: +353 21 453 6141
Fax: +353 21 453 6149


Customer Ref MW3
VOC Full Suite
Signed : 25/11/2013

NOTES
Page 19 of 20
ENVIRONMENTAL
LABORATORY SERVICES
Blackrock,
Cork
Ireland
Tel: +353 21 453 6141
Fax: +353 21 453 6149


Customer Ref MW3
VOC Full Suite
Signed : 25/11/2013

NOTES
Page 20 of 20
ATTACHMENT II
ENVIRONMENTAL
LABORATORY SERVICES
Blackrock,
Cork
Ireland
Tel: +353 21 453 6141
Fax: +353 21 453 6149


Customer Ref MW3
Ammonia
AQ2-UP1
Phosphate-Ortho(as P) EW154M-1 0.009 0.053 mg/l P INAB
Phosphate-Ortho (as PO4) EW154M-1 0.028 0.161 mg/l PO4
AQ2-UP2
COD
COD EW094 8 9 mg/L INAB
Ethyl Acetate EO089 0.1 <0.1 mg/L
GW Levels (Site)
Metals-Dissolved
Signed : 17/12/2013

NOTES
Page 1 of 20
ENVIRONMENTAL
LABORATORY SERVICES
Blackrock,
Cork
Ireland
Tel: +353 21 453 6141
Fax: +353 21 453 6149


Customer Ref MW3
Metals-Dissolved
Titralab
VOC Full Suite
Iodomethane/Methyl Iodide EO025 0.5 <0.5 ug/L
Analyst QC Comment QC:Due to quality failure during this test run the following result is indicative.
Signed : 17/12/2013

NOTES
Page 2 of 20
ENVIRONMENTAL
LABORATORY SERVICES
Blackrock,
Cork
Ireland
Tel: +353 21 453 6141
Fax: +353 21 453 6149


Customer Ref MW3
VOC Full Suite
Toluene EO025 0.5 <0.5 ug/L INAB
Signed : 17/12/2013

NOTES
Page 3 of 20
ENVIRONMENTAL
LABORATORY SERVICES
Blackrock,
Cork
Ireland
Tel: +353 21 453 6141
Fax: +353 21 453 6149


Customer Ref MW3
VOC Full Suite
Signed : 17/12/2013

NOTES
Page 4 of 20
ENVIRONMENTAL
LABORATORY SERVICES
Blackrock,
Cork
Ireland
Tel: +353 21 453 6141
Fax: +353 21 453 6149


Customer Ref AW6
Ammonia
AQ2-UP1
AQ2-UP2
Chloride EW154M-1 2.6 <2.6 mg/L INAB
COD
GW Levels (Site)
Metals-Dissolved
Signed : 17/12/2013

NOTES
Page 5 of 20
ENVIRONMENTAL
LABORATORY SERVICES
Blackrock,
Cork
Ireland
Tel: +353 21 453 6141
Fax: +353 21 453 6149


Customer Ref AW6
Metals-Dissolved
Titralab
VOC Full Suite
Signed : 17/12/2013

NOTES
Page 6 of 20
ENVIRONMENTAL
LABORATORY SERVICES
Blackrock,
Cork
Ireland
Tel: +353 21 453 6141
Fax: +353 21 453 6149


Customer Ref AW6
VOC Full Suite
Signed : 17/12/2013

NOTES
Page 7 of 20
ENVIRONMENTAL
LABORATORY SERVICES
Blackrock,
Cork
Ireland
Tel: +353 21 453 6141
Fax: +353 21 453 6149


Customer Ref AW6
VOC Full Suite
Signed : 17/12/2013

NOTES
Page 8 of 20
ENVIRONMENTAL
LABORATORY SERVICES
Blackrock,
Cork
Ireland
Tel: +353 21 453 6141
Fax: +353 21 453 6149


Customer Ref MW6
Ammonia
AQ2-UP1
AQ2-UP2
COD
GW Levels (Site)
Metals-Dissolved
Signed : 17/12/2013

NOTES
Page 9 of 20
ENVIRONMENTAL
LABORATORY SERVICES
Blackrock,
Cork
Ireland
Tel: +353 21 453 6141
Fax: +353 21 453 6149


Customer Ref MW6
Metals-Dissolved
Titralab
VOC Full Suite
Signed : 17/12/2013

NOTES
Page 10 of 20
ENVIRONMENTAL
LABORATORY SERVICES
Blackrock,
Cork
Ireland
Tel: +353 21 453 6141
Fax: +353 21 453 6149


Customer Ref MW6
VOC Full Suite
Signed : 17/12/2013

NOTES
Page 11 of 20
ENVIRONMENTAL
LABORATORY SERVICES
Blackrock,
Cork
Ireland
Tel: +353 21 453 6141
Fax: +353 21 453 6149


Customer Ref MW6
VOC Full Suite
Signed : 17/12/2013

NOTES
Page 12 of 20
ENVIRONMENTAL
LABORATORY SERVICES
Blackrock,
Cork
Ireland
Tel: +353 21 453 6141
Fax: +353 21 453 6149


Customer Ref MW1
Ammonia
AQ2-UP1
AQ2-UP2
COD
GW Levels (Site)
Metals-Dissolved
Signed : 17/12/2013

NOTES
Page 13 of 20
ENVIRONMENTAL
LABORATORY SERVICES
Blackrock,
Cork
Ireland
Tel: +353 21 453 6141
Fax: +353 21 453 6149


Customer Ref MW1
Metals-Dissolved
Titralab
VOC Full Suite
Signed : 17/12/2013

NOTES
Page 14 of 20
ENVIRONMENTAL
LABORATORY SERVICES
Blackrock,
Cork
Ireland
Tel: +353 21 453 6141
Fax: +353 21 453 6149


Customer Ref MW1
VOC Full Suite
Signed : 17/12/2013

NOTES
Page 15 of 20
ENVIRONMENTAL
LABORATORY SERVICES
Blackrock,
Cork
Ireland
Tel: +353 21 453 6141
Fax: +353 21 453 6149


Customer Ref MW1
VOC Full Suite
Signed : 17/12/2013

NOTES
Page 16 of 20
ENVIRONMENTAL
LABORATORY SERVICES
Blackrock,
Cork
Ireland
Tel: +353 21 453 6141
Fax: +353 21 453 6149


Customer Ref MW2
Ammonia
AQ2-UP1
AQ2-UP2
COD
GW Levels (Site)
Metals-Dissolved
Signed : 17/12/2013

NOTES
Page 17 of 20
ENVIRONMENTAL
LABORATORY SERVICES
Blackrock,
Cork
Ireland
Tel: +353 21 453 6141
Fax: +353 21 453 6149


Customer Ref MW2
Metals-Dissolved
Lead-Dissolved EM130 0.3 0.3 ug/L INAB
Titralab
Total Organic Carbon (TOC) EW123 0.25 <0.25 mg/L INAB
VOC Full Suite
Signed : 17/12/2013

NOTES
Page 18 of 20
ENVIRONMENTAL
LABORATORY SERVICES
Blackrock,
Cork
Ireland
Tel: +353 21 453 6141
Fax: +353 21 453 6149


Customer Ref MW2
VOC Full Suite
Signed : 17/12/2013

NOTES
Page 19 of 20
ENVIRONMENTAL
LABORATORY SERVICES
Blackrock,
Cork
Ireland
Tel: +353 21 453 6141
Fax: +353 21 453 6149


Customer Ref MW2
VOC Full Suite
Signed : 17/12/2013

NOTES
Page 20 of 20
ATTACHMENT III
Energy Audit Report 2013
Although the requirement for an Energy Audit was a new inclusion in the revised Integrated
Pollution Control Licence (IPCL) (Register Number 545) issued to Novartis Ringaskiddy Limited
by the EPA on 31-Oct-2000; and is also included in Condition 7 of IEL (Register Number
P0006-03) issued to Novartis Ringaskiddy Limited by the EPA on 02-Feb-2006, the company
has in fact been active in this field since 1994, when manufacturing operations commenced at
the facility. More detailed information is contained in the sub-section 4.10.1 of Revs 0 to 18 of
the company's EMP.
The report prepared for the Agency in respect of Condition 11 of IPCL Register Number 545
('Energy Audit') was forwarded on 12-Dec-2001 (our reference: IPC10222.doc) and was also
included in the AER for 2001.
During 2002 Novartis Ringaskiddy Limited participated in the Negotiated Agreement Pilot
Programme, coordinated by the then Sustainable Energy Ireland (SEI), as part of a National
initiative to identify ways in which the country can meet its agreed targets in respect of
stabilising and reducing emissions of Carbon Dioxide. Part of the programme required
participants to carry out an independent in-depth energy audit. Novartis Ringaskiddy Limited's
audit was carried out by Enviros Consulting Limited of Manchester, a company with significant
international and industrial experience. A copy of the audit report was forwarded to the Agency
as part of the AER for 2002.
The company suggests that both of the aforementioned documents meet the new requirement
of Condition 7.1 of IEL Register Number P0006-03.
As part of this on-going process the company, with the support of the then SEII commissioned a
technical review of site operations in respect of good energy management by the Danish
consultancy of Viegand Maagoe, which was undertaken during December of 2006. A copy of
this report together with a documentation gap analysis for the Irish Energy Management
Standard IS 393 was submitted as part of the AER for 2006. The outcome of the technical
review was implemented (where appropriate) by the site Energy Management Group.
To consolidate the progress made in respect of the aforementioned audits an additional

Novartis Pharma Corporate energy audit was undertaken by consultants BMG Engineering AG
between 01-Sep-2009 and 03-Sep-2009. The auditors presented a number of recommended
actions, which were followed up on at site level. A copy of the audit report was submitted as part
of the AER for 2009. The key recommendations from the audit of 2009 were summarised in this
corresponding section in the 2011 AER. A significant number of the recommended actions were
implemented over the course of 2010 to 2013 with the implementation of a significant low-
exegetic heat use project; a new heat recovery project; and planning for the possible generation
of renewable electricity at the facility. These projects are outlined in Rev 15, Rev 16, Rev 17
and Rev 18 of the companys EMP.
During 2013 the company continued to optimise its use of the Energy Monitoring System
(described in Rev 2 of the company's EMP); consolidated its participation in Sustainable Energy
Authority of Ireland's (SEAI) Annual Self Audit and Statement of Energy Accounts Scheme; and
fostered employee awareness, for example by participating in the Electricity Supply Board's
(ESB) Winter Demand Reduction Incentive; Energy Awareness Week; and by involving all of
the main energy consuming Process Units at the facility in the Energy Management Group.
Further information is presented in the companys Environmental Management Programme,
which is included elsewhere in this AER.
As noted in this corresponding section in the 2012 AER a new Novartis Pharma Corporate
energy and water audit was undertaken between 14-Nov-2012 and 16-Nov-2012. The audit was
conducted by energy experts from Novartis Pharma AG and energy consultants from BMG
Engineering Limited. A copy of the report was included in the 2012 AER.
The following is a summary of the energy (and water) saving opportunities identified in the 2102
audit. The company is elaborating a programme of work to implement as many of the
opportunities as is practical over the timeframe of 2013 to 2015.
The site has already defined own energy saving projects which sum up to ~0.75 MUSD/y
of cost savings. The energy savings realised with the implemented projects are sufficient
to fulfill the defined (Novartis Corporate) energy saving targets for 2015 already.
The detailed discussion on the electricity supplier contract shows that the site purchases
90% green electricity already. This helps to reach the defined (Novartis Corporate) GHG
targets. Without the purchasing of green electricity the achievement of the targets would
be more challenging.
The site plans to install 2 wind turbines. It should be pointed out, that the co-operation
with other companies in the area helps to reduce the effort for local approval procedures.
Note: Within the creation of the report the site has got the approval from the local
government to install only one turbine. The next steps would be starting the CAR process
of the project. The estimated additional CO2 reduction due to the wind turbines would
help to reach also future possibly more stringent (Novartis Corporate) targets as well as
to reduce dependency on the future market trend for green electricity (possible price
increase).
The future plans for the site growth as well as expected possible changes in production
would have a huge influence on the power supply and necessary modernisations and
extensions of the utilities on site. Most of the identified energy saving potentials from the
audit from 2009 have been realised. Also more complex projects, such as the district
heating system (DHS) using waste heat have been realised. Further "low hanging fruits"
are hard to find. More complex topics like changes on the steam generation or
improvements on the process units have not been evaluated in detail.
To proceed with the site development a holistic view is needed to define a site energy
strategy. The discussion during the assessment shows that it is most important to:
Define the major decision driver for the site (for example, cost, production growth,
GHG and energy saving targets).
Decide about future energy supply of the site (for example, new steam boiler)
including the future use of renewable energies (for example, the planned wind
turbine).
Furthermore, it is recommended to clarify the possible saving opportunities on the

process side more in detail (for example, changes in the hot and cold glycol loop).
Additionally, a number of energy saving potentials has been identified during the
assessment, which are recommended to be further analysed and evaluated by the sites
engineering group.
A total of energy cost savings of roughly ~1.5 MUSD/y (30 %) has been estimated
(including open projects from energy audit 2009 and site project list), which corresponds
to ~21 % of the sites energy costs (electricity and steam costs) in 2011.
A comparison of the relative consumption of natural gas and electricity at the facility is
presented on the following table. The table updates information that was forwarded as part of
the Energy Audit Report of December, 2001.
____________________________________________________________________________
Year Energy Source Relative Consumption

____________________________________________________________________________
1996 Natural Gas 4.32 GJ/kg product
2013 Natural Gas 0.49GJ/kg product
1996 Electricity 2.79 GJ/kg product
____________________________________________________________________________
Natural gas and electricity are the two main sources of energy utilised at Novartis Ringaskiddy
Limited.
Note that there was a significant impact on the energy metrics reported in the corresponding
section of the 2011 AER due to the later than anticipated start-up of the new E1W process in
the Diovan Process Unit during the first-quarter of 2011. Novartis Ringaskiddy Limited
demonstrated significant material and energy savings. These savings have effected primarily
through process modification and optimisation; and there is further scope for saving as the new
process is established by increasing yield. A full years savings could not be realised during
2011 as the new process was only successfully established at the end of the first-quarter. A
clearer view of the new process impact can be clearly seen in the data set for 2012 and 2013.
Effluent Toxicity Report 2013
Schedule C.3.2 of IEL Register Number P0006-03 requires that the toxicity of emissions to
sewer be monitored on an annual basis.
The company carried its annual toxicity testing, using the Shannon Aquatic Toxicity Laboratory
of Enterprise Ireland, during April of 2013. Data from this round of testing is presented in the
following attachment. The attached report was prepared on a twenty-four hour flow
proportionate composite sample of 580 m3, sampled between 08:00, Sunday, 14-Apr-2013, and
08:00, Monday, 15-Apr-2013. The sample was couriered directly to Enterprise Ireland following
completion of sampling.
The following is a summary of the report's findings:
___________________________________________________________________________
Test Species Test Parameter Number of Toxic Units
Psetta maxima (turbot) 96 hour LC50 < 3.1
Tisbe battagliai (marine copepod) 48 hour LC50 < 3.1
Vibrio fischeri (mictotox test) 30 minute EC50 < 2.2
___________________________________________________________________________
All tests were compliant with the emission limit value of 10 toxic units specified in Schedule B.3
of IEL Register Number P0006-03.
ATTACHMENT I
CONFIDENTIAL REPORT
SHANNON AQUATIC TOXICITY LABORATORY
Front Cover Report Sheet

Dept. Toxicity
Sheet no. 1 of 4 sheets Tox F020 Ver. 2.2
Customer Title
Novartis Ringaskiddy Ltd Toxicological analysis of two
Ringaskiddy samples
Co. Cork
Attn: Mr. Vincent Boyton
Report reference: 13T025 Order no.: OP-112142
Report by: Kathleen O Rourke

Robert Hernan
Date received: 15.04.13 Approved by: Ann Harte

Quality Manager
Copies to: R.6. Files Date of issue: 10.05.13
Standard Terms & Conditions for Testing and Consultancy Assignments
1. Reports issued by the Shannon Aquatic Toxicity Laboratory of 5. No action or legal proceeding shall be taken (except in the
Enterprise Ireland are copyright to Enterprise Ireland and shall case of wilful neglect or default) against Enterprise Ireland or
not be used, either in whole or in part, for the purpose of the Board or any member of the Board or any committee
advertising, publicity or litigation without the written consent appointed by the Board or any officer or servant of Enterprise
of the Chief Executive or his nominee. Ireland by reason of or arising out of the carrying out of
research, investigation, test or analysis or the publication of
2. Reports shall only be reproduced in full. the results thereof in the name of Enterprise Ireland.
3. Non-perishable samples received for testing or laboratory work 6. Enterprise Ireland will not release any information received
shall be disposed of after three months from date of receipt from or provided to the client in relation to this report
unless claimed or unless instructions to the contrary have except as may be required by law, including the Freedom of
been notified to Shannon Aquatic Toxicity Laboratory, Information Act 1997, or as specified by the client.
Enterprise Ireland by the client within the said three month
period.
7. This contract is governed by the laws of Ireland whose courts
4. Payment for work carried out shall be in accordance with the shall have exclusive jurisdiction.
terms stated on Enterprise Irelands invoices
Test report relates only to the sample(s) tested

TOXICOLOGICAL ANALYSIS REPORT Form No.: ToxF035-1 Ver 2.3
TEST RESULTS
Customer: Novartis Ringaskiddy Ltd
Customer sample description: Treated effluent, 24 h flow proportionate

composite sample,
14-15.04.13
Sample no.: 20130615
Tox. Ref. No.: 13T025-1
Test Date: 15.04.13 Psetta maxima

16.04.13 Tisbe battagliai
16.04.13 Vibrio fischeri
Test Results
Test Parameter Concentration Toxic Units 95% Method of
% vol./vol. Confidence Calculation
Limits
% vol./vol.
96 h LC50 to >32 <3.1 n/a n/a
Psetta maxima
48 h LC50 to >32 <3.1 n/a n/a
Tisbe battagliai
30 min EC50 to >45 <2.2 n/a n/a
Vibrio fischeri
Comments:
96 h LC50 to Psetta maxima

No mortality occurred at 32% vol./vol.
48 h LC50 to Tisbe battagliai

30 min EC50 to Vibrio fischeri

Less than 6% light inhibition occurred at 45% vol./vol.
- compared to the control.
Test Method(s): (see Appendix on back of page 4)

Method 7: Marine fish, Psetta maxima
Method 3: Marine copepod, Tisbe battagliai
Method 2: Marine bacterium, Vibrio fischeri
S:\SATL Reports\2013\13T025.doc Page 2 of 4

TEST RESULTS
Customer: Novartis Ringaskiddy Ltd
Customer sample description: Ash sample, 12.04.13,

Sample No.: 20130608
Tox. Ref. No.: 13T025-2E (eluate, 100g in 1L water,

15-16.04.13)
Test Date: 16.04.13
Test Results
Test Parameter Concentration Toxic Units 95% Method of
% vol./vol. Confidence Calculation
Limits
% vol./vol.
48 h LC50 to 30.7 3.3 26.3-40.4 Maximum
Tisbe battagliai Likelihood
Probit
30 min EC50 to 0.68 147 0.62-0.74 Microtox
Vibrio fischeri
*30 min EC50 to >45 <2.2 n/a n/a
Vibrio fischeri
Comments:
48 h LC50 to Tisbe battagliai

55% mortality occurred at 32% vol./vol.
5% mortality occurred at 18% vol./vol.
30 min EC50 to Vibrio fischeri: pH 12.6, Non-pH-adjusted

100% light inhibition occurred at 2.25% vol./vol.
*30 min EC50 to Vibrio fischeri: pH 7.4, pH-adjusted

Less than 6% light inhibition occurred at 45% vol./vol.
pH adjustment of the eluate was carried out with HCl (1.0M), prior to testing.
Test Method(s): (see Appendix on back of page 4)

Method 3: Marine copepod, Tisbe battagliai
Method 2: Marine bacterium, Vibrio fischeri
Method 11: Eluate generation

SAMPLE INFORMATION
SATL Customer Other

Sampled by:
3
Collected by: 3
Tox Ref. No. 13T025-1 13T025-2E
Sampling procedure n/a n/a
Date of analysis 15.04.13 16.04.13
Storage conditions (C) 33 33
Temperature (C) 17.9 21.0
pH 7.3 12.6
(at 18.1C) (at 21.3C)
Dissolved oxygen (mg/l) 5.7 8.5
Dissolved oxygen 61 94
(% saturation)
Conductivity 1029 8.1
(S/cm at 25C) (mS/cm at 25C)
Salinity (ppt at 20C) <1 4.5

Appendix
Toxicity Test Methods and Procedures
1. Freshwater Crustacean
Method 6.1 based on ISO 6341:1996/Cor.1:1998: Water quality Determination
of the inhibition of the mobility of Daphnia magna Straus (Cladocera, Crustacea)
Acute toxicity test
2. Marine Bacterium
Method 6.2 based on ISO 11348-3:2007: Water quality - Determination of the
inhibitory effect of water samples on the light emission of Vibrio fischeri
(Luminescent bacteria test) Part 3: Method using freeze-dried bacteria
3. Marine Copepod
Method 6.3 based on ISO 14669:1999: Water quality Determination of acute
lethal toxicity to marine copepods (Copepoda, Crustacea)
4. Marine Algae
Method 6.4 based on ISO 10253:2006: Water quality - Marine algal growth
inhibition test with Skeletonema costatum and Phaeodactylum tricornutum
5. Freshwater Algae
Method 6.5 based on ISO 8692:2004 : Water quality Freshwater algal growth
inhibition test with unicellular green algae
6. Freshwater Plant
Method 6.6 based on ISO 20079:2005: Water quality Determination of the
toxic effect of water constituents and waste water to duckweed (Lemna minor)
Duckweed growth inhibition test
7. Marine Fish
Method 6.7 based on OECD 1992: Guideline 203: - Fish, acute toxicity test
8. Freshwater Fish
Method 6.8 based on OECD 1992: Guideline 203: - Fish, acute toxicity test
9. Estuarine Crustacean
Method 6.9 based on MAFF SOP No. BEG/030:1996: Brown Shrimp (Crangon
crangon) 96 h acute toxicity for liquid effluents and wastes
10. Sampling
Method based on ISO 5667-16:1998: Water quality Sampling - Part 16:
Guidance on biotesting of samples
11. Eluate Generation

Procedure 4.7.8. Eluate Generation based on DIN 38 414 part 4, 1984:
Sludge and Sediments (Group S) Determination of leachability by water (S4)
The following pages contain the companys Environmental Liability Risk Assessment (ELRA),
which was updated at the start of 2014. It outlines the measures taken and/or adopted at the
site in relation to the prevention of environmental damage. Also enclosed is a letter of guarantee
making financial provision to cover any of the liabilities identified in the ELRA.
Note that the company completed a number of large capital projects during the course of 2008,
2009 and 2010 with a view to reducing previously identified potential liabilities. These are
described in the fourteenth revision to the companys Environmental Management Programme
(EMP), which was also submitted as part of the 2009 AER. The projects are reproduced here:
____________________________________________________________________________
4.5.3.11Provision of Secondary Containment for Lift Station (from Rev 11 Item complete)
The Wastewater Treatment Plant Lift Station was identified as a potential source of groundwater
contamination in the companys 2006 Environmental Liability Risk Assessment. To-date there
has been no evidence of groundwater contamination. This modification is of a precautionary
nature. A capital allocation of the order of 500,000 was made for this work and the work
described in sub-section 4.5.3.12 below.
Significantly reduced risk of groundwater contamination from the Wastewater Treatment Plant Lift
Station. This work was completed during the latter half of 2013.
4.5.3.12Provision of Secondary Containment for Neutralisation Basin (from Rev 11 Item complete)
The Wastewater Treatment Plant Neutralisation Basin was identified as a potential source of
groundwater contamination in the companys 2006 Environmental Liability Risk Assessment. To-
date there has been no evidence of groundwater contamination. This modification is of a
precautionary nature. A capital allocation of the order of 500,000 was made for this work and the
work described in sub-section 4.5.3.11 above.
Significantly reduced risk of groundwater contamination from the Wastewater Treatment Plant
Neutralisation Basin. This work was completed during the latter half of 2013.
4.5.3.13Provision of Additional Groundwater Monitoring Well (from Rev 11 Item complete)

The Wastewater Treatment Plant Lift Station and Neutralisation Basin were identified as a
potential source of groundwater contamination in the companys 2006 Environmental Liability
Risk Assessment. To-date there has been no evidence of groundwater contamination. This
modification is to enable additional groundwater monitoring to be undertaken in the vicinity of the
Wastewater Treatment Plant if required.
Significantly reduced risk of groundwater contamination from the Wastewater Treatment Plant Lift
Station. Additional groundwater monitoring point available in the vicinity of the Wastewater
Treatment Plant.
4.17.4.10 Increase Capacity of SWRP from 5,000 m3 to 10,000 m3 (From Rev 14 Item complete)
During 2009 Arup Consulting Engineers was asked to undertake a study of the companys
surface water protection system. The purpose of the system is to intercept large spillages
and cater for run-off of firewater in the event of a major incident on site.
The original design was to cater in a worst case scenario for the firewater that would be
generated in fighting a fire for two hours in the Tank Farm in addition to the then worst
case rainfall scenario. Since that time there have been a number of developments on site
that have resulted in a greater amount of paved areas than was originally foreseen but
perhaps more importantly the pattern of rainfall has also changed.
Arup subsequently issued a report on the outcome of the study titled 'Surface Water
Drainage and Fire Water Retention Pond Assessment'. The report found that:
Based on an analysis of the surface water drainage network, it is evident that the
existing network has the capacity to cater for the 20 year 24 hour rainfall event as
well as the firewater flow from the tank farm.
The network does experience a surcharge effect but this is an acceptable

hydraulic effect during a rainfall event of this return period.
The analysis of the capacity of the ponds has indicated that the capacity of the
ponds is not capable of meeting the required rainfall and firewater flow rates and
will need to have their existing capacity increased from a combined 5,000 m3 to
9,000 m3.
Civil work was initiated and progressed during the last three months of 2009 with a view to
increasing the retention capacity to 10,000 m3 in line with the Arup reports
recommendation. Additional work is also scheduled so that in addition to substantially
increasing the retention capacity of the Storm Water Retention Pond its operational
management will also be optimized.
The holding capacity of the Storm Water Retention Pond will match site requirements
taking into account all civil developments at the facility and also taking into account
updated meteorological data.
4.17.4.11 Install a Low Flow Transfer Station at the SWRP (From Rev 14 Item complete)
In parallel with the study referred to in item 4.17.4.10 above a requirement for some
facility for transferring surface water run-off collected under conditions of low flow but with
a high concentration of Total Organic Carbon (TOC) directly to the Wastewater Treatment
Plant was identified. This typically happens under conditions of low to no flow during dry
periods and when the on-line TOC analyser has no real sample to analyse. This will result
in the outlet of the Storm Water Retention Pond closing as a precautionary measure. The
issue is when this type of event is followed by normal rainfall that the holding capacity of
the Storm Water Retention Pond to cater for a real spillage is compromised pending a
sample being taken for laboratory analysis.
The new holding capacity of 10,000 m3 at the Storm Water Retention Pond will be
continuously available to meet the requirements of holding a significant spillage at the
facility; or water used in the event of a major incident at the facility.
The company also proceeded with a number of projects in 2012 with a view to consolidating the
work undertaken above (to reduce previously identified potential liabilities). These are described
in the sixteenth revision to the companys Environmental Management Programme (EMP),
which was also submitted as part of the 2013 AER. The projects, which will enhance surface
water and groundwater protection at the facility, are reproduced here:
4.17.4.12 Increase Holding Capacity of Spill Basins 1 and 2 (Item Complete)
A review is to be carried out on the capacity of both Spill Basins 1 and 2 (474.285 &
640.285), and the feasibility of increasing the liquid retention capacity of both basins is to
be evaluated. Subject to feasibility, the capacity of both basins is to be increased and this
is to be reflected an updated revision to the Arup report Review of Tankfarm and
Category 6 Warehouse Bund Capacity, 26 January 2013, Job No. C2978.12)
Provision of additional retention capacity for the Catchment Basins in the Tank Farm area
and enhanced surface water protection. Note that full details of this improvement can be
found in the document titled Review of Tankfarm and Category 6 Warehouse Bund
Capacity, 25 March 2013, Job No. C332978.12) which is included in the Surface Water
Emissions Report of Section 2 of this current AER.
4.17.4.13 Increase Holding Capacity of Spill Basin 2 (Item Complete)
A modification is proposed for Spill Basin 2 (640.285) involving its associated pumps;
pipework and automation that would enable Spill Basin 2 to be pumped out to a low level
in line with one of the recommendations of the Arup report Review of Tankfarm and
Category 6 Warehouse Bund Capacity, 26 January 2013, Job No. C2978.12)

Provision of additional retention capacity for the Catchment Basins in the Tank Farm area
and enhanced surface water protection. Note that full details of this improvement can be
found in the document titled Review of Tankfarm and Category 6 Warehouse Bund
Capacity, 25 March 2013, Job No. C332978.12) which is included in the Surface Water
Emissions Report of Section 2 of this current AER.
4.17.4.14 Connection of Category 6 Warehouse Sumps to Bunded Sewer Network (Item Complete)
A project is to be undertaken to connect all of the floor drains and sumps within the
Category 6 warehouse (area 661) to the bunded sewer network (020.285) in line with one
of the recommendations of the Arup report Review of Tankfarm and Category 6
Warehouse Bund Capacity, 26 January 2013, Job No. C2978.12)
Provision of additional retention capacity for the Category 6 Warehouse and enhanced
surface water protection. Note that full details of this improvement can be found in the
document titled Review of Tankfarm and Category 6 Warehouse Bund Capacity, 25
March 2013, Job No. C332978.12) which is included in the Surface Water Emissions
Report of Section 2 of this current AER.
4.17.4.15 Connection of Fuel Oil and Glycol Bunds to Process Sewer (Item Complete)
A surface water protection project is to be undertaken in the Utilities Area. The Glycol and
Fuel Oil Storage (430.350 and 430.500) systems have 4 separate bunds, each with its
own gully and valved outlet pipe which connects the bunds into the surface water manhole
ST38. The 4 bunds in question are as follows:
Glycol Bund.
Glycol Charging Station Bund.
Fuel Oil Bund.
Fuel Oil Pump Bund.
It is proposed to disconnect each of the bunds from the surface water drainage system,
and connect each of the bunds to the sites process sewer network.
Implementation of this change will prevent future potential contamination of surface water
runoff from the bunds and utility yard area into the surface water drainage system.
4.17.4.16 Prevention of a potential adverse reaction between Acetic Acid and Sodium Hydroxide
(Catchments Basins 4 and 5) (Item Complete)
An assessment was undertaken on the likelihood and possible impact of a reaction

between Acetic Acid and Sodium Hydroxide, which are both stored in bulk vessels within
the Tank Farm area (area 652) within separate catchments (both of which are connected
to Spill Basin 1). There are LEL detectors in Catchment Basin 4 and Spill Basin 1, which
will alarm in the event of an Acetic Acid spillage. LEL detectors will not alarm in the event
of a spillage of Sodium Hydroxide. Two modifications are proposed to be made in line with
the recommendations of the assessment:
Automation change - In the event of an LEL alarm in Catchment Basin 4 (where Acetic
Acid tank 652.201 is located) this should interlock all transfers into and all transfers out
of Sodium Hydroxide tank 652.212. Transfers will remain interlocked until such time as
any issue has been resolved and the LEL alarm has been reset.
Install a pH probe within Spill Basin 1 and/or Catchment Basin 5 (where Sodium
Hydroxide tank 652.201 is located), which will alarm in the event of it detecting a high pH
(- detecting a Sodium Hydroxide leak). Automation change associated with installing this
probe - in the event of a high pH alarm in Catchment Basin 5 this should interlock all
transfers into and all transfers out of Acetic tank 652.201. Transfers will remain interlocked
until such time as any issue has been resolved and the pH alarm has been reset. (Note
that it was subsequently decided to install a conductivity probe rather than a pH probe but
using the same principle that it alarms in the event of it detecting a high conductivity,
which would be indicative of a Sodium Hydroxide leak).
Implementation of this change will prevent future potential adverse reaction between
Acetic Acid and Sodium Hydroxide in the event of a leak from one or both of the bulk
storage tanks; and enhance surface water protection at the facility.
The company has now decided to proceed with a number of projects in 2014 with a view to
consolidating the work undertaken above (to reduce previously identified potential liabilities).
These are described in the current revision to the companys Environmental Management
Programme (EMP), which is also submitted as part of this AER for 2013. The projects, which
will enhance surface water and groundwater protection at the facility, are reproduced here:
4.17.4.17 Surface Water Protection Improvement Projects 2013/2014 (New Item)
A number of surface water protection improvement projects are scheduled to be

undertaken over the course of 2013/2014. These include:
Upgrading of the tiled bunded area located to the east of the Equalisation Tank in the
Wastewater Treatment Plant Area (2013) (Item now complete)
Repositioning of a valve set at Spill Basin 1 to ensure that it operates within a

catchment/bunded area in line with IPPC Licence requirements (2013) (Item now complete)
Upgrading of the Storm Water Retention Pond software to include a capacity alarm for
Environmental Controls Department operators (2014) (Item now complete)
Undertake all remedial works identified in the CCTV survey of the sites surface water
drainage system (2013) (Item now complete)
Reinstatement of the integrity of the sanitary sewer that runs from the Sports Clubs house
that is located on the west side of the site (2014).
Installation of a new drain in the Cooling Tower to facilitate ease of drainage to the process
sewer when testing and inspection is required (2014).
The schedule of works form part of an environmental Capital Allocation Request valued at
170,000 that has been approved on-site to enhance environmental protection at the facility.
The projects identified above will provide additional protection for surface water at the facility.
Environmental Liability Risk
Assessment 2014
DOCUMENT CONTROL SHEET
Client: Novartis Ringaskiddy Limited
Project Title: Environmental Liability Risk Assessment 2014
Document Title: Environmental Liability Risk Assessment Report
Document No: MDE0970Rp0013
DCS TOC Text List of Tables List of Figures No. of Appendices

This Document
Comprises:
1 1 48 - - 2
Rev. Status Author(s) Reviewed By Approved By Office of Origin Issue Date
D01 Draft P. Chadwick C. Reilly C. Reilly West Pier 15/04/2014
A01 Final P. Chadwick C. Reilly C. Reilly West Pier 12/05/2014
rpsgroup.com/ireland
Novartis Ringaskiddy Limited Environmental Liability Risk Assessment Report
TABLE OF CONTENTS
EXECUTIVE SUMMARY........................................................................................................................ III

1 INTRODUCTION ........................................................................................................................ 1
2 SCOPING ................................................................................................................................... 3
3 RISK IDENTIFICATION ............................................................................................................. 5
3.1 METHODOLOGY ................................................................................................................ 5
3.2 SITE OPERATION ............................................................................................................. 5

3.2.1 Production Buildings......................................................................................... 6
3.2.2 Tank Farm ........................................................................................................ 9
3.2.3 Solvent Recovery Unit .................................................................................... 11
3.2.4 Warehouses ................................................................................................... 12
3.2.5 Drainage Network........................................................................................... 12
3.2.6 Storm Water Retention Pond (SWRP) ........................................................... 13
3.2.7 Waste Water Treatment Plant (WWTP) ......................................................... 13
3.2.8 Liquid Vapour Incinerator (LVI) ...................................................................... 15
3.2.9 Solid Waste Incinerator (SWI) ........................................................................ 16
3.2.10 Utility Building and Service Yard .................................................................... 16
3.2.11 Technical Services Building ........................................................................... 16
3.3 OPERATOR PERFORMANCE ............................................................................................ 17
3.3.1 Environmental Management .......................................................................... 17
3.3.2 Compliance History ........................................................................................ 17
3.3.3 EPA Audit ....................................................................................................... 18
3.3.4 Complaints...................................................................................................... 18
3.3.5 Incidents ......................................................................................................... 18
3.4 ENVIRONMENTAL SENSITIVITY ........................................................................................ 19
3.4.1 Groundwater................................................................................................... 19
3.4.2 Surface Water................................................................................................. 19
3.4.3 Emissions to Sewer ........................................................................................ 20
3.4.4 Air Quality ....................................................................................................... 20
3.4.5 Human Beings ................................................................................................ 20
3.4.6 Natural Habitats and Protected Species ........................................................ 20
3.5 RISKS IDENTIFIED .......................................................................................................... 21
4 RISK ANALYSIS...................................................................................................................... 25
5 RISK EVALUATION................................................................................................................. 36
6 RISK TREATMENT.................................................................................................................. 40
7 QUANTIFICATION AND COSTING ........................................................................................ 43
7.1 IDENTIFICATION OF THE W ORST CASE SCENARIO ............................................................ 43
7.2 QUANTIFICATION AND COSTING ...................................................................................... 44
MDE0970Rp0013 i Rev A01

8 CONCLUSION ......................................................................................................................... 48
LIST OF FIGURES
Figure 3.1: Overview of Materials Flow on site ....................................................................................... 6
Figure 3.2: Flow Diagram of Material Flow through Production Buildings .............................................. 8
LIST OF TABLES
Table 2.1: IED activity classes relevant to the Novartis Ringaskiddy Limited facility.............................. 3
Table 3.1: Overview of catchment basins in the tank farm ................................................................... 10
Table 3.2: Modules contained in WWTP system .................................................................................. 14
Table 3.3: Project Risk Register ............................................................................................................ 22
Table 4.1: Risk Classification Table Likelihood .................................................................................. 25
Table 4.2: Risk Classification Table Consequence ............................................................................ 25
Table 4.3: Risk Analysis at the Novartis Ringaskiddy Limited facility ................................................... 27
Table 5.1: Risk evaluation table ............................................................................................................ 37
Table 5.2: Risk Matrix............................................................................................................................ 39
Table 6.1: Statement of Measures ........................................................................................................ 41
Table 7.1: Solvent treatment feasibility at the WWTP........................................................................... 45
Table 7.2: Quantification and Costing of Worst Case Scenario ............................................................ 47
APPENDICES
APPENDIX A Site Layout Map
APPENDIX B Parent Company Guarantee
MDE0970Rp0013 ii Rev A01

EXECUTIVE SUMMARY
Novartis Ringaskiddy Limited is a pharmaceutical production plant at Ringaskiddy, County Cork which
currently employs approximately 564 people and manufactures a wide range of speciality drug
substances used in the treatment of immunologic, dermatologic, cardiovascular, oncological and
central nervous system diseases. The end products are exported worldwide to formulation and
packaging plants, for incorporation into forms suitable for the end user (tablet, phial, etc.).
Novartis Ringaskiddy Limited is located on 53 ha site, 30 ha of which has been developed, on the
western side of a large industrially zoned area in Ringaskiddy, County Cork. Areas of mixed
agriculture and a number of small villages including Ringaskiddy itself border the industrial zone.
The site is licensed by the Environmental Protection Agency (Register Number P0006-03). The licence
was amended by the EPA in December 2013 to conform with the provisions and requirements of
Council Directive 2010/75/EU (the Industrial Emissions Directive) and as such is deemed an Industrial
Emissions Licence for the following activities:
5.16 The production of pharmaceutical products including intermediates (production means the
production on an industrial scale y chemical or biological processing)
11.2 (c) Disposal or recovery of hazardous waste with a capacity exceeding 10 tonnes per day
involving blending or mixing prior to submission to any of the other activities listed in
paragraph 11.2 or 11.3
11.2 (e) Disposal or recovery of hazardous waste with a capacity exceeding 10 tonnes per day
involving solvent reclamation or regeneration
11.3 (b)Disposal or recovery of waste in waste incineration plants or in waste incineration plants for
hazardous waste with a capacity exceeding 10 tonnes per day.
11.6 Temporary storage of hazardous waste, (other than waste referred to in paragraph 11.5)
pending any of the activities referred to in paragraph 11.2, 11.3, 11.5 or 11.7 with a total
where the waste is generated
The ELRA process follows the EPA Guidance on assessing and costing environmental liabilities
2014. This report updates the original ELRA prepared in 2006, which has been subsequently updated
on an annual basis to take account of the implementation of risk reduction measures at the facility, and
the current report reflects the existing risk profile of the Novartis Ringaskiddy Limited facility in 2014.
As part of this assessment a series of 55 plausible risks have been identified at the facility with the
potential to pose environmental damage. These risks cover all aspects of the site from the production
buildings, tank farm, wastewater treatment plant, etc. Each risk has been categorised based on the
potential likelihood of an incident occurring coupled with the consequence of the damage if that
incident occurs. Risks have then been ranked and for the highest risks a statement of mitigation
measures has been provided to reduce the future risk.
For the worst case risk, i.e. the risk that poses the maximum consequence, a detailed quantification
and costing of the liability incurred as a result of this incident occurring has been provided. In the case
of the Novartis Ringaskiddy Limited facility the worst case risk is considered to be a fire at the tank
farm (Risk ID 53). As a knock on effect of this risk there are a number of associated domino risks that
may also occur as a consequence of the fire relating to the firewater collection and containment
systems.
MDE0970Rp0013 iii Rev A01

These combined risks are considered the worst case scenario for the facility and are quantified and
costed for the purposes of financial provision. While each of these risks is predicted to have a very
low likelihood of occurrence, such an event represents the worst case liability and the financial
provision is based on such an event in line with EPA guidance.
The Financial Provision has been based on the combined risks that pose the worst case scenario.
This is the maximum liability that may be incurred at the facility and as such, financial provision for the
facility is calculated as 139,370 (including contingency) based on this event.
Novartis Ringaskiddy Limited has submitted a Parent Company Guarantee (Appendix B) to the EPA
in respect of financial provisions for potential unknown liabilities, taking the outcome of this updated
ELRA into account. This guarantee will be reviewed and updated as necessary to reflect changed
circumstance or risk profiles on site as identified during the ELRA process.
MDE0970Rp0013 iv Rev A01

1 INTRODUCTION
Novartis Ringaskiddy Limited in Ireland is involved in the distribution of medications and the
manufacture of drug substances for pharmaceuticals. Novartis Ringaskiddy Limited is the companys
pharmaceutical production plant located on a 53 ha site, 30 ha of which has been developed, at
Ringaskiddy, County Cork. The company currently employs approximately 564 people and
manufactures a wide range of speciality drug substances used in the treatment of immunologic,
dermatologic, cardiovascular, oncological and central nervous system diseases.
Ringaskiddy itself border the industrial zone.
The site is licensed by the Environmental Protection Agency (EPA) to carry out the following activities:
In December 2013, the facilities licence (Register Number: P0006-03) was amended by the EPA to
conform with the provisions and requirements of Council Directive 2010/75/EU and as such is deemed
an Industrial Emissions Licence.
A major part of the licensing upgrade focuses on the requirement of companies to assess their risks to
the environment and set aside adequate financial provisions to account for all environmental liabilities.
Condition 12.3 of licence P0006-03 specifically makes reference to these requirements. The
conditions are quoted below:
Condition 12.3 Environmental Liabilities
12.3.2 The licensee shall arrange for the completion, by an independent and appropriately
qualified consultant, of a comprehensive and fully costed Environmental Liabilities
Risk Assessment (ELRA), which addresses the liabilities from past and present
activities. The assessment shall include those liabilities and costs identified in
Condition 10 for execution of the RMP
MDE0970Rp0013 1 Rev A01

12.3.3 As part of the measures identified in Condition 12.3.1, the licensee shall, to the
satisfaction for the Agency, make financial provision to cover any liabilities identified in
Condition 12.3.2.
In order to meet this requirement, Novartis Ringaskiddy Limited prepared an initial ELRA in 2007 and
has carried out a series of annual reviews of the ELRA every subsequent year. This report presents
the findings of the ELRA review carried out in January 2014.
The ELRA process follows the EPA Guidance on assessing and costing environmental liabilities
2014.
MDE0970Rp0013 2 Rev A01

2 SCOPING
Novartis Ringaskiddy Limited is a pharmaceutical manufacturing company operating in Ringaskiddy,

Co. Cork. Novartis Ringaskiddy Limited is engaged in the manufacture of active substances for
speciality drugs used in the treatment of immunologic, dermatologic, cardiovascular, oncological and
central nervous system diseases.
The site is licensed by the Environmental Protection Agency (Register Number P0006-03) for the
activities listed in Table 2.1.
Table 2.1: IED activity classes relevant to the Novartis Ringaskiddy Limited facility
Class Activity
The production of pharmaceutical products including intermediates (production means the

5.16
production on an industrial scale by chemical or biological processing)
Disposal or recovery of hazardous waste with a capacity exceeding 10 tonnes per day involving
11.2 (c) blending or mixing prior to submission to any of the other activities listed in paragraph 11.2 or
11.3
Disposal or recovery of hazardous waste with a capacity exceeding 10 tonnes per day involving
11.2 (e)
solvent reclamation or regeneration
Disposal or recovery of waste in waste incineration plants or in waste co-incineration plants for
11.3 (b)
hazardous waste with a capacity exceeding 10 tonnes per day
Temporary storage of hazardous waste, (other than waste referred to in paragraph 11.5)
pending any of the activities referred to in paragraph 11.2, 11.3, 11.5 or 11.7 with a total capacity
11.6
exceeding 50 tonnes, other than temporary storage, pending collection, on the site where the
waste is generated
The scope of this ELRA is defined in Condition 12.2 as the liabilities from past and present activities.
As such, this ELRA considers all potential liabilities associated with incidents associated with all
operations located within the IED licence site boundary.
RPS undertakes an annual review of the ELRA for Novartis Ringaskiddy Limited and this report
presents the findings of the review undertaken in January 2014.
The ELRA review consisted of discussion of operational conditions on site with regard to alterations in
site operations and infrastructure since the previous review. While there have been no significant
alterations to manufacturing operations or site infrastructure since the previous ELRA, a series of two
additional risk items have been added to the risk register. In doing this, the scenarios developed in the
companys Safety Report that was prepared to meet the requirements of S.I. 74 Control of Major
Accidents involving Dangerous Substances Regulations 2006 were considered for inclusion in the
ELRA process.
The project risk register has been fully reviewed and all new hazards identified in this review have
been added. All hazards have been assessed as presented in Section 4 of this report.
Where mitigation measures have been fully implemented resulting in a reduction in risk score for a
hazard, the financial liabilities were recalculated using the updated risk score.
MDE0970Rp0013 3 Rev A01

Closure and aftercare liabilities associated with the plant are not addressed in this report but are
identified in full in the Closure, Restoration and Aftercare Management Plan (RPS Report
MDE0970Rp0013).
MDE0970Rp0013 4 Rev A01

3 RISK IDENTIFICATION
3.1 METHODOLOGY
Risk identification was initially undertaken during a Risk Management Workshop in 2007. This
workshop was chaired by RPS personnel and included the Novartis Ringaskiddy Limited
Environmental and Production managers. The risk identification process involved:
The identification of production processes that posed potential hazards to the environment.
The identification and quantification of the risks using a Failure Mode Effect Analysis (FMEA)
worksheet.
The identification of potential environmental receptors at the facility.
Further risk workshops were undertaken during the annual ELRA reviews and the risk identification
process identified in this report includes the combined risks of all reviews to date.
3.2 SITE OPERATION
The various processes undertaken at the Novartis Ringaskiddy Limited site have been identified
during the annual site walkovers. In order to gain an overview of the flow of materials, processes on
site and the relationship between each working area, Figure 3.1 over summarises the various flow of
materials raw materials to finished product.
MDE0970Rp0013 5 Rev A01

Figure 3.1: Overview of Materials Flow on site
Raw Solvents
Materials
Category Tank Farm Solvent Recovery

Warehouses
Lay-down
Production Building Production Building 1

2 (PB2) (PB1) and PB1A
SSF Associated with
PB1
Products Environmental Controls Module Products
Each of the identified areas has inherent environmental risks associated with them. A brief description
of each of the areas and a summary of their processes are included in the following sections.
3.2.1 Production Buildings
There are three main production buildings on the Novartis Ringaskiddy Limited site, which perform a
variety of operations required for the manufacture of bulk pharmaceutical actives, a summary of the
processes undertaken within the production buildings are outlined below and summarised in Figure
3.2.
A Small Scale Production plant was built and commissioned in 2008. The process undertaken is low
volume, high value. The process is integrated into the existing effluent treatment and air abatement
systems and there are no significant additional emissions or hazards associated with this building.
Production Building 1 (PB1): This is a seven story process building which contains a variety of multi-
purpose equipment ranging from reactors, crystallisers and separators, solid/liquid separators, driers,
evaporators and a range of auxiliary equipment which flow from top floor down. The production lines
can be configured for different production trains as required and the plant is capable of coping with all
standard processes required to produce fine chemicals.
Production Building 2 (PB2): This is a seven story process building which contains a variety of
equipment such as separators, reactors, crystallisers, dissolvers or various sizes, solid/liquid
MDE0970Rp0013 6 Rev A01

separators, driers, evaporators and a range of auxiliary equipment from top floor down. Equipment
within this building is used predominately for the same family of products, predominately Diovan and
Cyclosporine. The equipment is capable of being configured for different production trains however,
this occurs on a less frequent basis.
Production Building 1A (PB1A): This is a four story building used for process steps where a higher
degree of safety and environmental protection is required. The use of water reactive chemical
substances, hydrogenation, and low temperature reactions are all undertaken in this building. Much of
the equipment housed in this building is similar to that contained in PB1 and PB2.
The three buildings have been designed in order to contain any releases of substances within the
manufacturing process, in addition procedures are set down in order to minimise the potential for
environmental risks, and these include:
Process floor drains throughout the buildings flow directly into process drains. These drains
flow into the sites WWTP lift station, but can alternatively be diverted into Spill Basin 1 in the
event of a large spillage or release of liquids with high solvent concentrations.
All production trains in the production buildings are linked to the Liquid Vapour Incinerator
(LVI) for the purpose of vapour and off-gas treatment.
HVAC system in production buildings circulate air exchange, filters are replaced on regular
basis by dedicated team.
Containment suites are used for highly potent substances.
Raw materials are brought in on a strict requirement basis to avoid stockpiling within
production buildings.
Similarly, waste materials are suitably labelled and removed to designated storage areas post
generation.
Full clean down of vessels and equipment on regular basis.
Figure 3.2 provides an outline of the vertical processes within a typical production building
from top floor material input to ground floor product out.
The Small Scale facility (SSF) plant is located north of Production Building 1A. The SSF was
commissioned during 2008/09 and is now used for the manufacture of certain low volume high value
product. It is a relatively small two-storey building of modular design that will allow incorporation of
additional modules as required.
MDE0970Rp0013 7 Rev A01

Figure 3.2: Flow Diagram of Material Flow through Production Buildings
Top Floor
Liquids Charging Liquid
Filters Solids Charging
Vessels Vessels
Pumps
Separators Separators Liquids Solids Solids

Charging
Dryers / mill/ blenders Vessels
Dryer Unloading Pumps
Raw
Ground Floor Material
Products
MDE0970Rp0013 8 Rev A01

3.2.2 Tank Farm
This area is located to the north of the site and is used for the bulk storage of liquids, principally
solvents, which are directed into production buildings via overhead pipelines. Un-reusable and un-
recyclable waste solvent and process liquids awaiting incineration are stored in this area also. The
3
Tank Farm consists of 100 tank compartments with capacities ranging between 25 to 100m with a
3
total storage capacity of 3,200m .
The tank farm is bunded to contain any spillages and incompatible liquids are bunded separately. The
majority of materials stored in the tank farm are compatible. The notable exceptions are acetic acid
and sodium hydroxide (caustic) which are deliberately stored in tanks located in separate catchment
areas.
The primary bunds on site are operated on the basis of catchment areas, in so far as if a spill from a
tank occurs then the liquid is drained away from the tank area and directed to a remote storage bund
in either in Spill Basin 1 or Spill Basin 2. This procedure is in place in order to direct any flammable
liquid that may have leaked from a tank away from the remaining liquid being stored within the
catchment area. Table 3.1 provides an overview of the ten separate catchments in the tank farm, the
relevant spill basin and the number and type of tanks in each catchment.
Following an EPA audit in 2012, a series of recommendations were made in relation to the storage
and transfer of materials including the tank farm area and spill basins. A range of infrastructural
changes were implemented by Novartis Ringaskiddy Limited in these areas including the following:
Modifications to Spill Basins 1 and 2 to increase the capacities of both basins for compliance
with EPA guidance.
Modification to Spill Basin 2 to ensure that liquid is kept to the minimum level.
Installation of a conductivity probe in the Tank Farm Area to detect a leak of Sodium
Hydroxide. This compliments the existing LEL (lower explosive limit) detectors, which are
used to detect a leak of solvent.
These works have been fully implemented by the Novartis Ringaskiddy Limited team to reduce the risk
of incident at the facility. The current capacities of the infrastructure are presented below:
3
Spill Basin 1 has an actual volume of 299m and is located adjacent to the Wastewater Treatment
Plant and caters for the following bund/catchment areas:
Tank Farm Catchment Basins No.1, 2, 3, 4 and 5

Truck Unloading Area.
Solvent Recovery Area (East)
Liquid Vapour Incinerator
Bulk Storage Trailer Park
Pumped Discharge from Spill Basin 2
Warehouse No. 6
If any release of liquid is discharged to Spill Basin 1 then it is collected within the basin where it is
assessed and then pumped to the Wastewater Treatment Plant where possible. The Bulk Storage
Trailer Park has an overall capacity for fifteen Road Tankers, however it would be very unusual for all
the spaces to be occupied at the same time. Of the 15 spaces, there are 3 that are permanently
3
occupied by three 26m tankers (at the slow fill arms) while the remaining 12 other spaces cater for
MDE0970Rp0013 9 Rev A01

3
trailers with a capacity of 20m . The average number of road tankers stored in these spaces would be
6 to 7 but for the purpose of the bund capacity assessment all spaces are conservatively assumed as
occupied.
Table 3.1: Overview of catchment basins in the tank farm
Number of Catchment Total Tank

Spill Basin Catchment No. 3 3 Solvents
Tanks Volume (m ) Volume (m )
Butyl Acetate
Methyl Ethyl Ketone
1 8 87.168 272.24 n-Methylpiperizine
3-methyl-1-butanol
Solvent Waste
Tert butyl methyl ether
Ethyl Acetate
2 11 106.764 334.46 Heptane
Solvent Waste
Aqueous Waste
Toluene
Butanol
1 3 8 94.996 272.24
Cyclohexane
Ethanol
Tetrohydrofuran
Acetonitrile
Acetic Acid
t-amyl-alcohol
4 10 116.045 340.03
Isopropyl alcohol
Ethanol
Dimethyl formamide
Isopropyl acetate
Caustic
5 3 66.140 102.09
Solvent Waste
Isopropyl acetate
Acetone
Ethyl Acetate
6 10 170.013 621.63
Methanol
Isopropyl alcohol/water
Solvent Waste
7 8 109.829 372.78 Isopropyl acetate
Ethyl acetate
Ethyl acetate
Heptane/Isopropyl
2
8 10 141.122 620.20 alcohol
Heptane/Acetone
Acetone
Cyclohexane/Ethyl
acetate
9 12 88.176 466.65 Cyclohexane
Ethyl acetate
Ethyl acetate/Water
Isopropyl acetate
10 9 118.193 373.32 Tetrohydrofuran
Water/Acetone
3
Spill Basin 2 has an available volume of 162m and is located adjacent to Catchment Basin No.7 and
caters for the following catchment basins:
Tank Farm Catchment Basin No. 6, 7, 8, 9 and 10.
MDE0970Rp0013 10 Rev A01

The water level within Spill Basin 2 is kept to a minimum as a result of the installed low level outlet to
the surface water drain. In the event that the outlet valve is closed then the collected liquid is
automatically pumped to Spill Basin 1, which ensures that the water level in Spill Basin 2 is kept to the
minimum level which ensures that the maximum storage volume is maintained within Spill Basin 2.Spill
Basin 2 has been designed to pump any collected liquid directly into Spill Basin No.1. The combined
3
capacity of the two spill basin amounts to 461m . In the highly unlikely event that all tanks failed in the
above catchment basins, the liquid would discharge to the Storm Water Retention Pond via the
overflows in each spill basin.
A full review of the capacities of all bunding on site was carried out by Arup Consulting Engineers in
2013 and the relevant reports have been issued to and approved by the EPA. This review was carried
out to determine the compliance levels of all bunds with the EPA guidance as follows:
Containment bunds that cater for a single tank shall have a capacity equal to 110% of the
capacity of the tank.
Containment bunds that cater for more than one tank shall have a capacity of 110% of the
largest tank or 25% of the capacity of all the tanks whichever is the greater.
The following were the primary conclusions of this assessment:
Both Spill Basin No.1 and 2 can cater for liquid from either a single tank or multiple tank failure
within an individual catchment for both the 110% and 25% rule.
In a the unlikely catastrophic event of multiple tanks failing in multiple catchments basins then
liquids will discharge to both Spill Basins and any excess volumes will discharge to the Storm
3
Water Retention Pond which has a capacity of circa 10,000m storage. This scenario has
been the subject of a separate risk assessment that has been submitted to the EPA.
As a recommendation for site safety under the COMAH Regulations, Novartis Ringaskiddy Limited
propose to install a series of three gullies along the tank farm road to the south of the tank farm in
early 2014. The purpose of the gullies is to provide a mechanism of tertiary containment in the event
of a tank failure and subsequent bund overtopping. The natural gradient in the area is a southerly flow
towards the production buildings and the gullies will contain any overtopping at the tank farm road and
prevent the possibility of a flow of material to production causing a domino effect.
Another recommendation for site safety under the COMAH Regulations in the ECD area and the
construction of a 2.1 meter high wall between the above ground installation (AGI) and the slow fill
area. This wall will provide a physical barrier against any potential gas jet fire from the natural gas AGI
causing damage to a road tanker at tanker slow fill (or pool fire causing a gas explosion).
3.2.3 Solvent Recovery Unit
This area is located to the north east of the site and is involved in the recovery by distillation of
solvents from the processes. The unit consists of 15 distillation columns with still pots of varying
capacity. Solvents awaiting recovery and recovered solvents are stored in the main Tank Farm.
The recovery unit is bunded to contain any spillages. The capacity of each bund is not less than 110%
of the largest tank. All bunded areas or containment tanks are directly linked to the process flow
drains, which flow directly into a designated spill basin.
MDE0970Rp0013 11 Rev A01

3.2.4 Warehouses
A variety of storage warehouses are located within the Novartis Ringaskiddy Limited grounds, mostly
towards the east of the site. These are used for separate storage of raw materials, products and
intermediates. Each warehouse contains substances classified by their storage category using the
Novartis Corporate HSE warehouse guidelines. These segregate goods on their physical, ecological
and toxicological properties and their combustion properties. The design of each warehouse inclusive
of the layout, density of stock, fire control and other specific contingency arrangements are related to
the nature of the stored goods.
The Category 6 Warehouse is located to the north of the site adjacent to the Tank Farm. This
warehouse is used for the storage of flammable materials in containers typically of the order of 200
litres; although large IBCs of up to 1,000 litres can also be stored in this area. The warehouse has a
3
capacity to store 94.76m of materials (refer Arup Report Storm Water Protection Concept, March
3
2013). Allowing for the 110% rule the warehouse has a storage requirement for 1.1m (110% of pallet
3
storage volume) and based on the 25% rule the warehouse has a requirement to store 23.69m of
3
liquid. Given that the existing bund capacity in the warehouse is only 4.707m , the engineering review
concluded that connecting the existing open channels/bund directly to the process drainage network at
two locations from the warehouse was the optimum approach to ensure containment. In addition, leak
detection has also been installed within the open channels to provide an early warning system of any
uncontrolled discharge. This work has been completed and Warehouse 6 has now been integrated
into the bunded process network that drains to Spill Basin 1 (remote bund).
The Category 8 warehouse is located within the main warehouse and is used for the storage of non-
3
flammable materials with a capacity of 47.408m of material. The area is bunded with a series of floor
sumps to collect small scale spillages of up to one full container (e.g. a 200 litre container) with a
3
capacity of 4.61m . As such, the Category 8 warehouse does not currently comply with the 25% rule
3
and in the event that greater than 4 pallets (4m ) of material spilled then there would be a overspill of
containment. In such a scenario, the sumps would overflow and the material would drain to the SW
drainage network on the external areas of the warehouse and drain to the Storm Water Retention
Pond. Novartis Ringaskiddy Limited are currently carrying out a risk review to determine the potential
risk of more than four pallets spilling simultaneously.
During 2013 a number of operational controls have also been introduced for the warehouse:
The warehouses have been upgraded to replace the existing racking.
Liquid materials can no longer be stored above ground level.
SAP control systems have been implemented to reduce the risk of operations.
As a result, the potential for incident in the warehouses is reduced and the subsequent impact of a
discharge from the Category 6 warehouse is also reduced due to the improved containment.
3.2.5 Drainage Network
The process drainage network is made up of process floor drains throughout the production buildings
which flow directly into process flow chambers external to the buildings. These chambers flow into the
WWTP lift station and ultimately to the WWTP for treatment. The discharges can alternatively be
diverted into Spill Basin 1 in the event of a large spillage or release of liquids with high solvent
concentrations. All process drains are contained uPVC pipes (a pipe within a pipe) and are tested and
inspected every three years as per the conditions of the licence. In 2013 the following infrastructural
changes were made to the network.
MDE0970Rp0013 12 Rev A01

A process drain was installed at the cooling tower that diverts any spill or residue into the
process network.
The capacity of the process flow chambers was enhanced through the modification of the inlet
chamber and installation of an overflow diverting to the storm water network.
The surface water network diverts all storm flows across the site to the SWRP as described in the
following section.
3.2.6 Storm Water Retention Pond (SWRP)
The storm water retention pond is located to the south west of the site, within the lowest gradient area
of the site. This consists of two separated lined holding lagoons with a combined storage capacity of
3
10,000m . The pond is used to avoid the possible discharge of contaminated surface water arising
from a spill and/or fire incident or other accident involving contaminated water flowing into the storm
water drain system. All water flowing into this system is continuously monitored with a system in place
for retaining any contaminated water in the event of exceedance of storm sewer water quality limits
which can be pumped directly back to the WWTP for treatment prior to discharge.
The system delivers a warning alarm and an automatic shut off mechanism of the valve between the
storm ponds and the discharge outlet when levels of pH and/or TOC are at the warning emission
levels, set by Novartis Ringaskiddy Limited. The alarm alerts the environmental control division that
there is a drift in the storm water quality. A second alarm is activated when storm water levels are at
action emission levels. This system ensures that no contaminated water in breach of the sites IED
Emission Limit Values (ELVs) occurs.
Following from the study undertaken by Novartis Ringaskiddy Limited in 2009 (refer to report Surface
Water Drainage and Fire Water Retention Pond Assessment, Arup Consulting Engineers, 07-Aug-
3
2009) retention capacity at the Storm Water Retention Pond was increased from 5,000m to the
3
current 10,000m .
To ensure that maximum capacity is available at all times, a Low Flow Transfer Station (LFTS) with
TOC monitor was installed on inflow, which can automatically divert small volume, high TOC water to
the WWTP during normal operations. The LFTS was commissioned in 2010 and is now fully
operational.
3.2.7 Waste Water Treatment Plant (WWTP)
This area is located to the east of the site and is used to treat all process water and sewer water prior
to discharge from the site. As a direct result of the potential hazards identified during the ELRA
procedure in 2007, Novartis Ringaskiddy Limited implemented major works at the WWTP in 2008. The
process water lift station was removed and a new tank installed above ground. The old tank (concrete)
was inspected during removal and was observed to be in good condition with no evidence of leakage.
The new tank is visible and of stainless steel construction.
Work was also undertaken on the neutralisation basin to provide additional protection through the
installation of a stainless steel tank. The neutralisation basin is now contained in a bund within a
bund. Novartis Ringaskiddy Limited invested heavily in this mitigation project with total costs in
excess of 500,000 for the WWTP works. The system is now comprised of the modules outlined in
Table 3.2
MDE0970Rp0013 13 Rev A01

The containment system for the chemical dosing area at the WWTP was upgraded in 2012 and
included the construction of a designated bunded area for the dosing chemicals (phosphoric acid, urea
and anti-foam polymers).
Table 3.2: Modules contained in WWTP system
Original
Module Source of Water Function Controls
Construction
Sealed/lined
Stainless steel tank,
gases vented to
Liquid Vapour
Process Water Incinerator (LVI) Production and utility
Pumping Station
Lift station Since major works buildings, floor drains
in 2008, the entire
structure is now
visible and free
standing
Sanitary Lift Underground,
Sanitary effluent Pumping Station
Station concrete tank
Underground, lined Tank farm/solvent
Spill Basin concrete tank open to recovery/liquid vapour Pumping Station
the surface incinerator bunds
Overground, lined
concrete tank , fitted All monitoring
Primary
Equalisation Tank with monitoring Process Lift Station and control
Treatment
system, covered and functions are
vented to LVI controlled by
Above ground, free Distributed
Neutralization standing tank lined Primary Control Systems
Equalisation Tank by gravity
Basin stainless steel, vented Treatment (DCS)
to LVI
Overground, lined
Pumped from Neutralization Secondary
Aeration Basin concrete tank covered
Basin Treatment
and vented to LVI
Overground, Fed by gravity from Aeration Secondary
Clarifier
permaglass tank basin Treatment
Overground, lined
concrete tank,
Digester Discharged from Clarifier Sludge Handling
covered and vented to
LVI
Mechanical Press
Sludge
Belt Filter Press Filter, bunded in Pumped from Digester
Dewatering
building
Pumped from Digester
Steel drum and motor, Sludge
Centrifuge (used as alternative to Belt
bunded in building Dewatering
filter press)
The three Aeration Tanks in the WWTP used a Jet Aeration/Mixing System to meet the Biological
Oxygen Demand (BOD). This method of aerating and mixing uses a relatively large amount of energy.
The one Digester tank in uses an alternative Diffused Aeration system. Over the course of 2013 and
2014, Novartis Ringaskiddy Limited proposed to remove the existing jet aeration/mixing pumps and
associated pipework from the three aeration tanks and install a high efficiency Fine Bubble Diffused
Aeration System that supplies the required amount of air on demand.
During 2013, the tiled bunded area for the storage of sulphuric acid to the south of the neutralisation
tank in the WWTP area was noted to be in significant disrepair. A potential spillage of acid may have
lifted the tiles and compromised the integrity of the bund. Novartis Ringaskiddy Limited immediately
undertook bund repair works followed by a full integrity test to ensure that integrity of the bund was
reinstated. A detailed investigation indicated that no soil contamination arose as a result of the
damage to the bund
MDE0970Rp0013 14 Rev A01

During May, June and July of 2013 compliance issues were recorded with regard to the COD
emissions from the WWTP. A rapid root cause investigation was carried out by Novartis Ringaskiddy
Limited to identify the issue and it was found that a modified cleaning practice in the production areas
was the cause. The cleaning practices were using sporocides which impaired the biological treatment
capacity in the WWTP once the sporocides drained to the plant. A corrective action system was put in
place to ensure that the incidents would not be repeated. Novartis Ringaskiddy Limited communicated
the above incidents and corrective actions to the EPA at the time.
3.2.8 Liquid Vapour Incinerator (LVI)
The LVI is located to the east of the site boundary in the environmental controls area of the site. This
system is used for the destruction of non-recoverable solvents, process wastes and process vapours
in addition to the recovery of heat for steam generation and energy conservation. The system consists
of the following elements:
A series of 5 liquid feed tanks

A vapour intake system
A combustion chamber
A heat recovery unit to provide district heating to the production buildings.
Cooling and washing of the flue gases in a water quench section.
Further washing of the flue gases in a packed Chlorine scrubber.
Air emissions are monitored on a continual basis using the Continuous Emissions Monitoring System
(CEMS), which compares emissions against the requirements of the European Waste Incineration
Directive. The unit has an automatic shut down system in place in the event of temperature drop,
and/or emission limit value exceedance. The site incinerator emission analyser software has
undergone a full upgrade in 2013 to comply with EPA guidelines.
Liquid waste tanks on the LVI are located in catchments that drain via the bunded sewer network to a
remote bund (Spill Basin 1) whose contents are transferred to the WWTP.
There is an aqueous discharge from the quench and scrubber of the LVI. This is a licensed discharge
reference W1 and is subject to the limits specified in Schedule B.3 of the IED licence prior to
entering the WWTP.
In 2011, Novartis Ringaskiddy Limited installed a Wet Electrostatic Precipitator (WESP) at the LVI to
treat the off gases from the incineration process. This additional abatement facilitated the increased
treatment of solvents with high inorganic salt content without the subsequent emissions of inorganic
particulate matter. This lead to a corresponding decrease in the volumes of waste solvent sent for
disposal off-site and an increase in heat recovery and subsequent decrease in natural gas
consumption.
As a back up to the LVI, there is a Redundant Vapour Treatment Module (RVTM) located adjacent to
the LVI. The RVTM operates for a total of approximately two weeks per year during periods when the
LVI is undergoing maintenance. Both sources discharge through the same emission point and are
subject to the same emission limit values (Emission Point Reference No. 4, Schedule B).
The RVTM does not have the facility to treat chlorinated vapours, so when the RVTM is on line, the
emission licence limit for chlorine can be exceeded resulting in the need to stop process steps using
chlorinated materials. The product mix using chlorinated materials at Novartis Ringaskiddy Limited
MDE0970Rp0013 15 Rev A01

has increased from 10 weeks production in 2008 to 35 weeks in 2012. During operations in 2011,
elevated levels of HCl were periodically detected being emitted from the RVTM and a series of internal
investigations were carried out to identify the source. Novartis Ringaskiddy Limited determined that
the RVTM had difficulty abating the Chlorine constituent in production off gases and procedures have
been implemented to ensure no such gases are discharged to the RVTM during the two week period
of back up operation. During 2013 a chlorine vapour abatement equipment (quench, scrubber and
reheater) was installed on the RVTM outlet. The quench will cool the exhaust vapours and the
scrubber will remove Chlorine Acid vapours (HCl), controlling the sites Chlorine (HCl) limit when the
RVTM is on line.
The current location of the tanker slow fill at Area 572 is in close proximity to the LVI combustor heads.
A potential hazard exists whereby a leaking gas main at the combustor heads could cause a road
tanker explosion. This slow fill area will be relocated during 2014 to the Tanker Slow Fill (Area 576).
3.2.9 Solid Waste Incinerator (SWI)
The SWI is located to the east of the site boundary in the environmental controls area of the site.
This incinerator is a much smaller system than that of the LVI. It is used for the destruction of
contaminated packaging and other combustible wastes. The system consists of multiple chambers
fired with natural gas and a flue gas cleaning system. Air emissions are monitored on a continual
basis using the CEMS which compares emissions against the requirements of the European Waste
Incineration Directive. Environmental controls include automatic lock out of additional waste allowed
into chambers if any of the control parameters are outside optimal operating ranges, predominately
temperature ranges or exceedences in ELVs which are continually monitored.
3.2.10 Utility Building and Service Yard
This area of the facility is located within the mid west area of the site and houses the heating systems
consisting of two gas fired boilers with oil as backup, air compressors, water softening plant and
chillers. External to the building, the services yard contains a cooling tower, a gasoil fired generator
and a bunded fuel oil and glycol storage area. During 2012, all drains have been tied directly to the
process drainage network which discharges directly to the WWTP to ensure all spills/emissions are
captured and treated.
The building is laid over underground floor drains, which in the event of accident or spill would drain
into the process drains. Any contamination therefore flows into the lift station for treatment in the
WWTP. Any chemicals or dangerous substances are held in contained bunds within this area of the
building.
There is an external paved yard located to the north of the Utility Building that is used for the
segregation of non-hazardous waste arising from on-going projects around the facility. The storage
area was constructed of gravel aggregate but this has been replaced with a hard standing tarmac
base in 2012 in line with an EPA request in 2011.
3.2.11 Technical Services Building
This building is used for the maintenance and repair of plant and equipment, a workshop and also
houses the works fire brigade.
MDE0970Rp0013 16 Rev A01

3.3 OPERATOR PERFORMANCE
3.3.1 Environmental Management
Novartis Ringaskiddy Limiteds Environmental Management System and its environmental

performance is reported on to the public in accordance with the Community Eco-Management and
Audit Scheme (EMAS) (Registration Number IE - 002) as required under Regulation 1221/2009. With
the publication of this independently verified document Novartis Ringaskiddy Limited has recently
completed sixteen years of continuous participation in EMAS. Novartis Ringaskiddy Limited was the
first Irish company in the Chemical/Pharmaceutical sector to register under the scheme. During the
EMAS audit of December 2013 no non-conformances were issued to Novartis Ringaskiddy Limited by
the auditors. The next EMAS audit is due in June of 2014.
3.3.2 Compliance History
The following is a summary of the compliance status of the Novartis Ringaskiddy Limited facility
In 2011, the Solid Water Incinerator (SWI) demonstrated 100% compliance in terms of ELVs (10
minute; 30 minute; 24 hour means). Similarly mass discharges of all parameters (10 minute; 30
minute; and 24 hour means) were in 100 % compliance. Dioxin and dibenzofuran; hydrogen fluoride
and hydrogen bromide; and metal emissions were in 100 % compliance.
In 2012 there were five noted breaches of the CO emission limit on the SWI (30 min average). An
investigation was carried out by Novartis Ringaskiddy Limited management and identified the source
of the breaches as fibre waste containers which have a high calorific value resulting in high CO levels.
Waste management practices have been altered at the site to ensure this waste stream is prohibited
from entering the SWI in future events.
In 2013, the SWI demonstrated 99% compliance, with three noted breaches of the CO emission limit
on the SWI (30 min average). An investigation was carried out by Novartis Ringaskiddy Limited
management and identified the source of the breaches as an off-set on the CO analyser needed to be
reset to its normal operational position following QAL2 validation. The primary cause of the third
breach was the introduction of two lots of solid waste rather than one which resulted in a short-term
reduction in oxygen concentrations that resulted in the generation of CO.
In 2011, the Liquid Vapour Incinerator (LVI) demonstrated 100% compliance in terms of ELVs (10
minute; 30 minute; and 24 hour means), with the exception of two twenty-four hour (concentration)
means for Hydrochloric Acid; one twenty-four hour (concentration) mean for particulates (Dust); and
one thirty-minute (concentration) mean for Carbon Monoxide. Mass discharges of all parameters (10
minute; 30 minute; and 24 hour means) were in 100 % compliance, with the exception of one thirty-
minute mean for Particulates (out of a total of 17,449 readings). Dioxin and dibenzofuran; hydrogen
fluoride and hydrogen bromide; and metal emissions were in 100 % compliance. In 2013, daily mass
discharges of all parameters demonstrated 100% compliance with the requirements of the Industrial
Emissions licence.
Emissions from the waste water treatment plant demonstrate 100% compliance with the ELVs of the
Industrial Emissions licence in 2011, with the exception of Total Ammonia which demonstrated 98%
compliance (Non-compliance 1 out of 52 readings). In April 2012, two further deviations from the
ELVs were noted for ammonia in this discharge. A rapid route cause investigation was carried out by
Novartis Ringaskiddy Limited management and identified the source of the breaches in the production
process. A subsequent corrective action procedure has been put in place to modify the process and
prohibit further breaches. In 2013, emissions from the waste water treatment plan demonstrated 100%
compliance with the ELVs, with the exception of Total Suspended Solids and Chemical Oxygen
Demand, which demonstrated 97% compliance (Non-compliance 10 out of 365 readings) and 89%
MDE0970Rp0013 17 Rev A01

compliance (Non-compliance 41 out of 365 readings) respectively. A rapid Root Cause Investigation
was carried out by Novartis Ringaskiddy Limited management over a number of weeks and identified
the root cause as the use of a new sanitising agent in some of the production clean rooms, which was
introduced at a time when the WWTP was operating on one aeration basin. A number of continuing
corrective actions were implemented.
Noise levels at the boundary of Novartis Ringaskiddy Limited were demonstrated to be compliant with
the requirements of the IED Licence Register Number P0006-03 during the annual sound level
surveys between 2004 and 2013.
The quality of the groundwater beneath the facility has remained the same as that established prior to
the commencement of the development at Novartis Ringaskiddy Limited.
All surface water leaving the site was monitored, found to be of an acceptable quality for discharge
and conformed to the requirements of the IED Licence Register Number P0006-03.
3.3.3 EPA Audit
rd
The EPA carried out an audit of the Novartis Ringaskiddy Limited facility on the 23 April 2013. The
EPA issued one non compliance to the facility relating to the following:
Bund register incomplete include the mobile bunds and bulk storage trailer park as part of
the catchment area for spill basin 1.
This non-compliance was addressed to the satisfaction of the EPA. A total of thirteen observations
were also issued following the audit and were addressed to the satisfaction of the EPA.
3.3.4 Complaints
In 2013, two complaints (one noise and one odour) made directly to Novartis Ringaskiddy Limited and
the EPA by one individual. Both complaints were investigated by the company and both the EPA and
the complainant were updated on the outcomes of the investigations. The company evaluated that
there was no significant adverse environmental impact associated with these complaints.
3.3.5 Incidents
In 2013, Novartis Ringaskiddy Limited did not report any major incident to the EPA during 2013. Fifty-
four readings out of a total of more than 228,000 were judged to be in non-compliance and were
reported to the EPA. All non-compliances were judged to be minor deviations and did not present the
Elevated 30-min mean CO from the SWI (3 in total)
Elevated Suspended Solids from the WWTP (10 in total)
Elevated COD from the WWTP (41 in total)
Each of these incidents was considered minor with no significant damage to the surrounding
environment.
MDE0970Rp0013 18 Rev A01

3.4 ENVIRONMENTAL SENSITIVITY
The term environmental receptors describes those parts of the surroundings likely to be affected by
the processes that are ongoing at the Novartis Ringaskiddy Limited site. The significant environmental
receptors are listed below. These receptors are used as a starting point to ensure that all significant
hazards are identified and all major aspects of the environment are taken into account.
On the 2009 implementation of the Environmental Liabilities Regulations in Ireland (Statutory

Instrument 547 of 2008), Novartis Ringaskiddy Limited (as a Schedule 3 activity) are also liable for
damages to natural habitats and protected species. As such, these environmental receptors are
included in this assessment.
Groundwater
Surface Water
Human Beings
Air Quality
Natural Habitats and Protected Species
3.4.1 Groundwater
As part of the sites licence, emissions to groundwater are monitored on a bi-annual basis at four
groundwater monitoring wells (MW-1, MW-2, MW-3 and AW-6) all located within the grounds of the
facility. The locations of the wells have been chosen to represent the most vulnerable areas down
gradient of groundwater flowing throughout the site.
In late 2010 a new groundwater well (MW6) was installed beside the lift station for the wastewater
treatment plant. This well was recorded as dry in 2011 but subsequent monitoring in 2012 and 2013
has yielded groundwater. To date, two rounds of groundwater monitoring from this borehole have
been undertaken and all results confirm that the quality of the groundwater beneath the facility remains
the same as that established in the baseline studies undertaken prior to the commencement of
production activities in the early 1990s.
Monitoring parameters are as per Schedule C6 of the licence. The quality of groundwater is assessed
in terms of the drift in quality between ambient baseline determined before the facility commenced
operation. Monitoring to date at these wells up to 2013 has not resulted in any change in quality when
compared to baseline quality levels when manufacturing activities commenced at the facility. This
indicates that there has been no observed impact to groundwater quality from the facilitys operation.
3.4.2 Surface Water
Surface water is collected through a series of storm water drain networks around the site from building
roofs, roads and all hard standing areas. The storm water drains flow directly via a buried gravity drain
into the storm water retention pond located in the south west of the site and out to the Cork County
Council storm water sewer. Water flowing into the retention pond is monitored using a continual water
chemical monitoring system to check compliance with water quality levels suitable for discharge into
the storm water sewer. The system checks levels of pH and Total Organic Carbon (TOC) the levels of
which are fed back to the Environmental Controls Department (ECD). Monitoring of the surface water
discharge has shown full compliance in the Annual Environmental Reports (AER) to-date. The storm
water drainage network is inspected as part of the three-yearly programme of testing and inspection of
underground pipes.
MDE0970Rp0013 19 Rev A01

3.4.3 Emissions to Sewer
Novartis Ringaskiddy Limited operates an enclosed wastewater treatment plant (WWTP) that is used
to treat lightly contaminated water that is used in processing activities, in addition to sanitary
wastewater. The effluent is treated by a mixture of physical and biological treatment before being
discharged to the Local Authoritys (Cork County Council) marine outfall pipeline. This pipeline
services a number of local towns and industries and discharges in deep water in the outer section of
Cork Harbour.
3.4.4 Air Quality
Emissions to atmosphere are from four main emission points on the site as follows:
Solid Waste Incinerator (SWI, Emission Point No. 3).
Liquid Vapour Incinerator/Vapour Treatment Module (LVI, Emission Point 4).
Two natural gas boilers.
Both incinerator are equipped with CEMS and operate within the stringent controls set out in Schedule
C.1.1 and emission limits set out in Schedule B.1 of the IED licence. The total quantities and waste
streams that are permitted for disposal in each of the SWI and LVI are restricted to the limits
presented in Schedule A of the licence. One of the principle restrictions on material being combusted
in the incinerators is a <1% organohalogen content as specified in Schedule A.2 Table A.2 Waste
Categories for disposal by incineration on-site.
3.4.5 Human Beings
The location of the Novartis Ringaskiddy Limited site is situated northwest of the village of Ringaskiddy
within IDA industrial estate grounds.
The nearest residential receptors to the site boundary are located adjacent to the western site
boundary. The distance between site buildings and activities are approximately 200-300m from the
nearest properties.
The operation of the site will be most noticeable in terms of noise emissions and potentially from
odours. Noise levels are monitored as part of the sites IED licence on an annual basis. This includes
measurements at the sites boundary and at the nearest noise sensitive locations. The facility must
comply with noise emission limits of 55dB LAeq during day time hours and 45dB LAeq during night time
periods. The operation of the Novartis Ringaskiddy Limited site has shown full compliance with these
day and night time licence limits to date. Odours are controlled through ventilation systems on the
WWTP and enclosed venting systems leaving the production buildings to the LVI.
3.4.6 Natural Habitats and Protected Species
Under the definitions of the Environmental Liability Regulations, damage to natural habitats and
protected species means any damage that has significant adverse effects on reaching or maintaining
the favourable conservation status of certain habitats or species. The species and habitats covered
MDE0970Rp0013 20 Rev A01

are those listed in Annex I of the Birds Directive (79/409/EEC) and Annex I, II or IV of the Habitats
Directive (92/43/EEC).
Novartis Ringaskiddy Limited has been carrying out annual bird surveys at the facility since 2007 to
monitor local biodiversity with results published in the annual environmental statements. The most
recent survey was carried out in 2013 and no Annex I species are identified on the site.
The nearest designated ecological site to the Novartis Ringaskiddy Limited facility is the Cork Harbour
Special Protection Area (SPA Site Code 4030). The SPA site comprises most of the main intertidal
areas of Cork Harbour, including all of the North Channel, the Douglas Estuary, inner Lough Mahon,
Lough Beg, Whitegate Bay and the Rostellan inlet. The nearest point to the Novartis Ringaskiddy
Limited facility is the Lough Beg estuary approximately 700 metres east of the facility boundary.
Given the remote nature of the designated habitats and the absence of protected species on the site,
the potential for impacts to these ecological receptors is low.
3.5 RISKS IDENTIFIED
As part of the original ELRA in 2007, a facilitated workshop was undertaken on site to systematically
identify the risks at the site. A total of 42 risks were identified in the 2007 workshop and these have
been reviewed on an annual basis with additional risks added to the register as required. Up to 2013
there have been 53 hazards identified at the Novartis Ringaskiddy Limited facility. During the 2014
review one additional hazard has been identified following a cross check with the COMAH Safety
Report and a second has been added based on a recorded bund integrity concern as follows:
Risk ID 54: Release of Toxic Gas (Hydrogen Chloride)
Risk ID 55: Failure of Sulphuric Acid bund at WWTP
The combined list of all risks identified on site are summarised in Table 3.3. The risks identified are a
general overview of potential risks within each area of the Novartis Ringaskiddy Limited site as
determined over the period 2007 to 2014.
As a general overview of the facilities activities and control measures in place, many of the risks
identified do not pose a significant risk due to the safeguards already in place at the facility. A large
majority of the risks identified relate to potential spillages/leaks and risks to ground and water
contamination. These potential risks rely heavily on the integrity of the various bunds, catchment
areas, spill basins and process and solvent drains. These control measures are therefore the
weakest link in the risk chain and have been therefore given high priority as part of the assessment.
All underground pipes/lines and tanks similarly are automatically at a higher risk due to the potential
for undetected leaks occurring from these structures containing potentially contaminated substances.
MDE0970Rp0013 21 Rev A01

Table 3.3: Project Risk Register
Principle Impacted
Risk Area/Issue Potential Failure Mode / Risk
Receptors
Production Buildings 1 and 2
1 Manifold connections Minor Spillages Solvents Groundwater/Soils
Backfill of materials resulting in
2 Manifold management Groundwater/Soils
overfill of tanks
Air Quality/Residential
3 Hydrogenator in PB1 Explosion of Hydrogenator Properties/
Groundwater/Soils
4 Plant equipment Potential Failure of reaction vessels Groundwater/Soils
Dryer in Cyclosporine
5 Seal failure in cyclosporine dryer Groundwater/Soils
process in PB1
6 Production floor Spillages of solvents- bio-degradable Groundwater/Soils
Spillages of solvents- non bio-
7 Production floor Groundwater/Soils
degradable
Air Quality/ Human Beings
8 HVAC Failure of HVAC filter systems
Properties
50 Fire in Production Major fire in production areas
Groundwater/Soils
Production Building 1A
Air Quality/Residential
9 Hydrogenator Explosion of Hydrogenator Properties/
Groundwater/Soils
10 Plant equipment PB1 Solid/powder spill Groundwater/Soils
General spillages in process non-
11 Production floor Groundwater/Soils
biodegradable material (up to 300kg)
Explosion of reacting materials if Air Quality/ Human Beings
12 Water sensitive materials
exposed to water /Groundwater/Soils
Warehouse
Spillage of Materials from storage
13 Minor spillage of substances Groundwater/Soils
vessels
43 Category 8 warehouse Major Spillage of liquid Groundwater/Soils
44 Category 6 warehouse Major Spillage of liquid Groundwater/Soils
51 Fire in Main Warehouse Major fire in main warehouse
Groundwater/Soils
52 Fire in Category 6 warehouse Major fire in Category 6 warehouse
Groundwater/Soils
Release of Toxic Gas Unscheduled release of HCl gas to
54 Air Quality/ Human Beings
(Hydrogen Chloride) atmosphere.
Tank Farm
14 Delivery of solvents Overturned tanker Groundwater/Soils
Failure of tanks over catchment
15 Catchment basins 6-9 Groundwater/Soils
basins
Failure of tanks over catchment
16 Catchment basins 1-5 Groundwater/Soils
basins
17 Tanks Manual leaks due to sampling points Groundwater/Soils
Leaks from failure of flange (gasket
18 Tanks Groundwater/Soils
failing) valves breaking
Failure of overhead lines/leaks in
19 Overhead lines (Solvent) Groundwater/Soils
lines
20 Loading bay Leaking between tanker and tanks Groundwater/Soils
53 Fire in Tank Farm Major fire in the tank farm
Groundwater/Soils
MDE0970Rp0013 22 Rev A01

Principle Impacted
Receptors
Overfill of tankers to rear of
21 Loading area Groundwater/Soils
incinerator
Redundant Vapour Treatment Air Quality/Residential
47 Elevated emissions of HCl
Module (RVTM) Properties
Solid Waste Incinerator
Burning of unauthorised material in
22 Burning of material Air Quality/Human Beings
incinerator
23 Release to Atmosphere Exceedences in ELV's of Dioxins Human Beings
Transport of waste ash/liquid Accident from haulage vehicle
24 Human Beings
waste transporting waste ash & liquid waste
Waste (general)
Metal Waste Drum Potential for contaminated drums
25 Human Beings
Decontamination being exported for recycling
Waste Oil in Process Potential for spillages/leaks of waste
26 Groundwater/Soils
Buildings oil in process areas
Storage of waste skips on gravel area
Non-Haz waste storage yard
48 and potential for ground Groundwater/Soils
for projects
contamination
Solvent Recovery unit
27 Purging process Build up for solid residue in still pot Groundwater/Soils
Storm Water Retention Pond
Overflow of retention pond due to
28 Pond Capacity inadequate capacity (worst case Groundwater/Soils
scenario)
29 Pond Lining Leakage from liner Groundwater/Soils
Process Drains
30 Line Integrity Stainless steel lines Groundwater/Soils
31 Line Integrity Double containment lines Groundwater/Soils
32 Spill basin 1 Potential leaks Groundwater/Soils
33 Spill basin 2 Potential leaks Groundwater/Soils
Potential degradation of concrete
34 Storm drains Groundwater/Soils
lines
35 WWTP tanks (overground ) Potential leakage from tanks Groundwater/Soils
WWTP underground tanks -
36 Potential leaks to underground Groundwater/Soils
lift station
WWTP underground tanks-
37 Potential leaks to underground Groundwater/Soils
neutralisation tank
Major Spillage of liquid to SB1 and
45 Spill Basin 1 (SB1) Groundwater/Soils
failure/overflow of SB1
Major Spillage of liquid to SB2 and
46 Spill Basin 2 (SB2) Groundwater/Soils
Breach of catchment tray used for
WWTP dosing chemical
49 secondary containment of dosing Groundwater/Soils
storage
chemicals
WWTP sulphuric acid bund
55 Loss of sulphuric acid to ground. Groundwater/Soils
failure
External Storage Areas
Risks from leaking of fuel oil tank
38 Fuel Oil Groundwater/Soils
(into bund)
39 Fuel Oil Filling of tanks Groundwater/Soils
40 Fuel Oil Filling of Vehicles Groundwater/Soils
41 Glycol storage Potential leakage Groundwater/Soils
MDE0970Rp0013 23 Rev A01

Principle Impacted
Receptors
Potential for contamination of
Solvent usage for cleaning
42 degreasing materials for tool Groundwater/Soils
tools in workshop
cleaning.
MDE0970Rp0013 24 Rev A01

4 RISK ANALYSIS
Potential hazards identified in Table 3.3 are assessed against the Risk Classification Tables (RCT) in
Tables 4.1 and 4.2. The RCTs were designed to reflect the levels of risk appropriate to the Novartis
Ringaskiddy Limited facility. Ratings, taken from the risk classification table, were applied to the
severity and likelihood of occurrence of each risk. A risk score was calculated for each risk using the
ratings.
Table 4.1: Risk Classification Table Likelihood
Likelihood
Rating
Category Description
1 Very Low Very low chance of hazard occurring
2 Low Low chance of hazard occurring
3 Medium Medium chance of hazard occurring
4 High High chance of hazard occurring
5 Very High Very high chance of hazard occurring
Table 4.2: Risk Classification Table Consequence
Consequence
Rating
Category Description
1 Trivial No damage or negligible change to the environment.
2 Minor Minor impact/localised or nuisance and low clean up costs.
3 Moderate Moderate damage to environment and significant clean up costs.
4 Major Severe damage to local environment and remediation cost required.
Massive damage to a large area, irreversible in medium term and
5 Massive
significant remediation costs.
Table 4.3 sets out the risk analysis register for those risks identified in Table 3.3 against the criteria in
Tables 4.1 and 4.2. This risk analysis is carried out based on the current mitigation controls in place
at the time of the assessment.
The key risks identified in at the Novartis Ringaskiddy Limited facility are presented in Table 4.3 and a
description of each heading of the table is presented below:
Risk ID Provides a unique identifier for each risk.
Processes Lists the sites process which gives rise to the potential risk.
Potential failure mode / risk Identifies the potential failure mode that could result in the risk
occurring.
Likelihood Rates the likelihood of the potential risk occurring given the current controls. The
occurrence rating is ranked against the Risk Classification Table (RCT) as provided in Table
4.1.
Basis for likelihood rating Identifies the basis for the selected occurrence rating.
MDE0970Rp0013 25 Rev A01

Consequence Rates the environmental impact and potential costs due to the risk event
occurring given the current controls ranked against the Risk Classification Table (RCT) as
provided in Table 4.2.
Basis for consequence rating Identifies the basis for the selected consequence rating.
Risk score Provides a risk score to allow the ranking of each risk. The risk score is based on
the product of the consequence rating and the likelihood rating for the hazard.
Table 4.3 presents the full list of all risks identified in the annual reviews from 2007 to 2014.
MDE0970Rp0013 26 Rev A01

Table 4.3: Risk Analysis at the Novartis Ringaskiddy Limited facility
Risk
Risk ID Process Potential Hazards Likelihood Basis of Likelihood Consequence Basis of Consequence
Score
Connections from Manifolds part of daily Spillages caught in floor drains of building
Manifold Minor Spillages
1 5 processes, leaks likely to occur on a very high 1 and into contained treatment system. No 5
Connections Solvents
frequency. major cost for clean up.
Leak from sample points occurs on a regular
Manual leaks from basis (sample frequency 2-4 times per day) Tank containment basins flow into spill
17 Tank Farm 5 1 5
tanks sampling points due to non correct closure of lids, overfilling of basin, and treated on site.
tanker.
All liquids in bund are chemically tested
Some Glycol is sent back from PB1 to small prior to discharge. If contaminated,
Potential leakage from
tank in bund and into other larger tanks, one pumped out and treated. Cost absorbed
41 Glycol storage tank/connections into 5 1 5
in 5 samples from bund (3 month period) will in operating system. Since 2012
bund
be contaminated. drainage network connected to process
drains and WWTP so all spills captured.
Testing undertaken every 3 years for integrity,
regular checks for visual inspection, single Underground structure, leaks may go
32 Spill Basin 1 Potential leaks 2 containment basin with potential of mixed 2 undetected and lead to high investigation 4
solvents held in tank. Capacity increased and and clean up costs.
new control valve installed in 2013.
Testing undertaken every 3 years for integrity,
Underground structure leaking may go
regular checks for visual inspection. Pump
33 Spill Basin 2 Potential leaks 2 2 undetected and lead to high investigation 4
installed which diverts standing water to SB1.
and clean up costs.
Capacity increased in 2013.
Any large leaks would be detected as
Tanks are visually inspected as over ground,
WWTP tanks Potential leakage from over ground. Low contamination in water
35 2 tanks tested twice to date on site. All passed 2 4
(over ground ) tanks (>90% water) typically with biodegradable
tests for integrity.
solvent. No chlorinated solvents.
Wide range of flammable liquids stored in
Category 6 Warehouse in moderate
No firewater resulting. Some cleanup of
Fire in the Category 6 quantities. Cat 6 warehouse employs a foam
52 Warehouse 2 2 the foam suppressant and fire materials 4
Warehouse suppressant to stop fire no firewater.
from the warehouse.
Emergency Response Team on site with
rapid fire fighting response.
Occurred in 2013 whereby a small leak of One IBC of material maximum stored at
WWTP sulphuric Loss of sulphuric acid acid lifted all of the tiles within the bund. The any time. While the immediate impact to
55 2 2 4
acid bund failure to ground. bund remained in tack and integrity tests ground would be severe there would be
showed no loss to ground. No long term residual impacts.
MDE0970Rp0013 27 Rev A01

Risk
Score
Leaks from failure of Flange (gasket breaking) valve may fail
Any solvents released are caught in
18 Tank Farm flange on tanks (gasket 4 (failure to close). Has happened to date on 1 4
control system and treated on site.
failing) valves breaking site but rare.
Filling of mobile Potential Spillages are caught in new bund and

Occurs on regular basis during normal
39 tanks from fuel leakage/spillage to 4 1 surrounding area connected to process 4
operation.
oil tank ground drainage network.
All solvent and fire water would discharge

to process drains and diverted lift station
and WWTP. Some material may overtop
Low volumes of material stored in Production
process network and overflow may enter
Fire in a Production Buildings. Production buildings equipped with
50 Production 1 3 SW network and would discharge to 3
Building sprinkler system. Emergency Response
Storm Water Retention Pond. Firewater
Team on site with rapid fire fighting response.
would be contained and tested followed
by treatment in WWTP or tankered off
site.
All fire water would discharge to process
Flammable materials not stored in the main
drains and diverted lift station and
Fire in the Main warehouse. Warehouse equipped with
51 Warehouse 1 3 WWTP. Firewater would be contained 3
Warehouse sprinkler system. Emergency Response
and tested followed by treatment in
Team on site with rapid fire fighting response.
WWTP or tankered off site.
All solvent and fire water would discharge
Wide range of flammable liquids stored in to spill basins and onto Storm Water
Tank Farm in large quantities COMAH Retention Pond. Firewater would be
Lower Tier Site. Tanks separated by contained and tested followed by
53 Tank Farm Fire in the Tank Farm 1 3 3
catchments and equipped with sprinkler treatment in WWTP or tankered off site.
system. Emergency Response Team on site Any solvent that overtops the bund will be
with rapid fire fighting response. retained in the newly installed gullies
along the tank farm road.
Overspill is caught in control system, may
potentially result in contamination of
Manifold lines can be misconnected and
Misconnections of lines tanker with mixing of solvents, additional
result in product filling back to tanker, has
Manifold resulting in overflow of cost of incineration. Small volume
2 3 happened previously. In 2012 there was a 1 3 3
Management tanks as a result of (83m ). Underground structures are
new roll out of staff training in the area of
backfilling considered to pose highest severity in
routine and non-routing manifold connections.
terms of potential ground contamination
and clean up costs
MDE0970Rp0013 28 Rev A01

Risk
Score
Instructions on proper handling may not be
Production Spillages of bio- Fully contained in control system and
6 3 followed leading to incidents. Opening of 1 3
Floors degradable solvents treated in WWTP
incorrect values, mis-reading labels etc
Small volumes <200 litres. Any spillages
PB2 contains highest volume of non- caught in process drains which flow into
Spillages of solvents-
7 Production Floor 3 biodegradable substances, potential for 1 WWTP system. Potential for some 3
non bio-degradable
spillages during non-routine operations leaking between source and holding area
leading to potential minor impacts
No dispensing, offload all in contained system
comes in as raw material in drums. Contained Spillages all contained in control system
Plant equipment
10 Solid/powder spillage 3 system with PTS, control is to sweep up and 1 and treated accordingly. Worst case - 3
PB 1&2
avoid where possible going down drain. 10kg spillage
Washed with water in drains (<1kg)
All spillages flow into process drains.
Spillage In process Minor spillages have occurred in past most
Production Floor Filters fitted on inlet to WWTP. Material
11 non-biodegradable 3 likely to occur during non-routine operations. 1 3
of PB1A cleaned and disposed of off site as
material (up to 300kg) Manual intervention, opening closed system
waste.
Spillages are caught in concrete plinth
Filling of Potential external to bund, potential for waste oil to
Occurrence reduced as only 4 filling
40 vehicles from leakage/spillage to 3 1 seep into ground below, area not subject 3
operations carried out per year.
fuel oil tank ground to test. Potential clean up and
investigation costs
Potential for Small amounts used over long time
Degreasing agents used on site, waste
Solvent usage contaminated of period, all containers are within contained
42 3 degreaser is stored and held in tanks and 1 3
for cleaning tools solvents to warehouse bunds, floor drains flow into WWTP.
removed off site
floor Process sewer flows into oil interceptor
Located at side of building to explode
Hasn't occurred to date on plant. Strict
outwards. Majority of content would be
Hydrogenator Explosion of controls in place in accordance with BAT
3 1 2 contained in event of explosion, in 2
PB2 Hydrogenator in PB2 guidance. Inert environment with strictly
process drains, vapour drains, etc.
controlled EX rated equipment.
Potential release to external area is low
Annex building designed for hydrogen
reaction safety including vessels in
contained room, detectors in building and
System designed to BAT and safety
Hydrogenator in dedicated H2 vents etc ejected materials
9 Risk of explosion 1 guidelines. No history to date of failure or 2 2
Annex 1 inside and outside building, emergency
faults
system will have controlled severity.
Release of solvent and debris- flow into
process drains (potential into storm
MDE0970Rp0013 29 Rev A01

Risk
Score
drains redirected to WWTP). Costs of
external clean up and small soil/ground
testing required to sign off as clean up
Predominant damage contained inside,

Potential for reaction of potential damage to lines and building. If
Held in contained and segregated areas,
PB1A water sensitive exploded outside, potential for
12 1 control systems in place. No such instances 2 2
Production areas materials leading to contamination of small grassed area-
have occurred to date
explosion ground water and soil in non-paved and
non bunded areas external to plant
Tanks are designed to withstand impact in Potential impact will be ground
Delivery of Overturned tanker
case of accident. Traffic management contamination from non-paved or non
14 Solvents to Tank during vehicle 1 2 2
controls, speed limits on site, low congestion bunded areas. Typical volumes less than
Farm movement on site 3
on site. No incident in sites history to date 10m .
LEL detection from Spill Basin 2, tank
contains rainwater which is now emptied
Failure of tanks over No tank failure or rupture of tanks recorded in
Catchment regularly, potential for overflow into
catchment basins, site history. No history of damage of tank
15 Basins 6-10 in 1 2 surface water drains and into SWRP. 2
leading to ground (rusting) or tap leaking to date. Probability of
Tank Farm Considered minor- contained in either
contamination full rupture very low
spill pits or SWRP and sent back to
WWTP for treatment or pumped out
No tank failure or rupture of tanks recorded in
Catchment
Failure of tanks over site history. No history of damage of tank Spillage diverts towards Spill Basin 1 and
16 Basins 1-5 in 1 2 2
catchment basins (rusting) or tap leaking to date. Probability of pumped out for treatment
Tank Farm
full rupture very low
Potential for accidents on haul route.
Typically during cold and icy weather
Accident from haulage Major severity if accident occurred, cost
Transport of impacting roads. All internal roads are salted
vehicle transporting high, 24 hr staff from Novartis
24 waste ash/liquid 1 as required. There has never been a haulage 2 2
waste ash & liquid Ringaskiddy Limited on call trained in
waste on site accident recorded at the site in 15 years of
waste accident/emergency procedures
operation. In 2011 all road markings were
upgraded to improve visibility.
MDE0970Rp0013 30 Rev A01

Risk
Score
Exothermic decomposition- unlikely to occur
Build up for solid due to purging process, process risk Control measures in place reduce
Solvent residue in still pot assessment has identified such risks. Filter severity of risk. May lead to explosion,
27 1 2 2
Recovery Unit resulting in exothermic on incoming feed & automated system- leads can lead to fracturing of line and potential
reaction to emergency cooling and disables production spray onto non-hard surfaces
process
Stainless steel lines from tank farms
inspected every 3 yrs including CCTV, visual Undetected leaking to ground if
Stainless steel Loss of integrity of inspections of manholes, bund tests line tests undetected between 3 year surveys can
drains between stainless steel lines etc. Small potential for hairline fractures in lead to high clean up costs and ground
30 1 2 2
tank farm and resulting in ground line with minor leakages going to ground. investigation costs. However, a major
spill basins contamination Incidences of spilling have been recorded but leak would be easily detected by control
these are very rare and are dependant on a room.
line rupturing.
Inspections every 3 years. Leaks detection
Leakages in lines may result in major
tests undertaken periodically. Manholes
costs due to high reliance as a control
Process drains inspected on site- under 'as need'
Line integrity of double measure Undetected leaking to ground if
31 from production 1 requirement, if observations made. Double 2 2
contained uPVC lines undetected between 3 year surveys can
buildings contained lines provide additional safeguard.
lead to high clean up costs and ground
Significant leaks would be detected at the
investigation costs.
LFTS.
Major spillage would require several tanks to
rupture simultaneously. The existing remote SB1 is diverted straight to the Storm
bund is designed to contain 110% of the Pond in the event of an overflow. May
Major Spillage of liquid
Spill Basin 1 largest tank and is integrity checked every 3 require use of tankers to remove waste
45 to SB1 and 1 2 2
(SB1) years. All drains in the remote bund material from Storm Pond. SB1 is larger
failure/overflow of SB1 3
equipped with detectors which immediately (299m ) than SB2 and would require
alert control room, fire crew and security of more costs to deal with the discharge.
the breach to limit any spill.
Major spillage would require several tanks to
rupture simultaneously. The existing remote If there was an overflow to SB2, the
bund is designed to contain 110% of the excess is discharged to SB1 and then
Spill Basin 2 largest tank and is integrity checked every 3 diverted to the Storm Pond for
46 to SB2 and 1 2 2
(SB2) years. All drains in the remote bund containment. May require use of tankers
equipped with detectors which immediately to remove waste material from Storm
alert control room, fire crew and security of Pond
the breach to limit any spill.
Potential Failure of Regular inspection of system, computerised Any release from vessel caught in
Plant equipment
4 reaction vessels 2 maintenance system in place as control 1 process drains, vapour is removed via 2
PB 1&2
leading to spillage of measure vapour hoods, some solvent can
MDE0970Rp0013 31 Rev A01

Risk
Score
product potentially drain into storm water system,
fed back to WWTP due to containment in
lagoon and detection method in system.
Cost of clean up will not be major due to
systems of control already in place
Seal failure in Release of powder/slurry from dryer, rare
Dryer in
cyclosporine dryer, occurrence, never happened in production, Fully contained, treated in WWTP, all
5 Cyclosporine 2 1 2
leading to release of happened once during cleaning of drum. products in PB2 are fully bio-degradable
process PB2
product Cleaning occurs 4 times per year on 4 dryers
Drums washed in production area, visually
Potential for and LEL (gas) checked and recorded.
Metal Waste
contaminated drums Manually labelled - not tracked, labels are Potential for contamination at end waste
25 Drum 2 1 2
being exported for kept on drums. Most hazardous materials are receiver
Decontamination
recycling dry and lined in drum. Some double/tripled
lined
Degradation of Since 2012 this lines are tested as part of the
Large dilution washed down drain from
concrete lines leading 3 year integrity cycle. Concrete underground
34 Storm drains 2 1 rainwater and dilution of any spills. 2
to potential ground pipes, likelihood of leaking over 30 year
Severity of contamination low
contamination periods, medium
Any liquids in contained bunds are
Risks from leaking of Potential for tank leakage over 30 yr life span,
38 Fuel Oil Tank 2 1 pumped to WWTP for treatment. 2
fuel oil tank (into bund) also potential for leaks in connections
Controlled in system
Storage of waste skips Some potential for surface water run off
Non-Hazardous Storage area was located in gravel yard
on gravel area and from the waste skips but very low
48 waste storage 2 adjacent to Utilities Building up to 2012. Yard 1 2
potential for ground potential for contamination of ground or
yard for projects not hard standing tarmac and kerbed.
contamination groundwater.
Failure of HVAC filter
Low, regular inspection of filters visually and
systems resulting in Low, internal building has containment
of pressure differential changes etc.
8 HVAC potential release of 1 1 measures for all high risk category 1
Dedicated team of staff for all HVAC systems
lightly contaminated air substances
involved in maintenance checking
emissions
Low, no spillage occurrence during life span Low, materials are segregated according
Spillage of Materials of Plant, control measures in place. Tanks are to substance and category type. All areas
13 Warehouse 1 1 1
from storage vessels designed to withstand impact in case of connected to process drains and
accident treatment areas
MDE0970Rp0013 32 Rev A01

Risk
Score
Stainless steel welded lines, with exception of Over paved areas, going to storm drains
Failure of overhead flange areas. For non-routine applications and detected in storm detection system.
Overhead lines lines/leaks in lines, lines tested prior and after production. For Can be contained. Pump feeding line
19 1 1 1
(Solvent) leading to ground routine areas, no checks of lines. Would be would continue to run unless manually
contamination detected in storm monitoring system. No switched off. Detection sys in storm water
failure to date in 13 yr period retention would trigger
Tankers are double valved; tankers are
chalked and charged during filling. Overfilling
Leaking/spillages Tanker filling area in hard-standing area,
of tank unlikely due to switch off mechanism
20 Loading Bay between tanker and 1 1 any spillages from leaking are contained 1
when full. Flow rates are slow due to gravity
tanks in process drains flowing into spill basin
filling. Occurrence very low- never happened
to date
Overfill of tankers to Low, automatic filling system with alarm
Liquid Vapour Low all spillages caught in process flow
21 rear of incinerator in 1 system in place, no history of overfill in life 1 1
Incinerator drains/spill basin
loading area span of site
Has occurred in past, controlled by training in
Burning of place for staff, tracking system in place for ID,
Solid Waste
22 unauthorised material 1 measuring system in place, person 1 Low. No major cost for clean up 1
Incinerator
in incinerator responsible for packing can be traced. This
has reduced frequency of occurrence
Monitoring of SWI has resulted typically full
compliance, through independent and EPA No major cost to clean up. Any
Solid Waste Exceedance in Dioxins
23 1 monitoring. Use of system does not allow 1 exceedance would be minor and short 1
Incinerator ELVs
burning to occur below required temperature, lived
switch off and door lock mechanism in place
Potential for Waste Oil contained in IBC's on plastic mobile Held in bunded pallets and flow into
Process spillages/leaks of bunds/pallets. Oil handling study undertaken process drains if overflowed. Potential
26 1 1 1
Buildings waste oil in process on site- findings of report all implemented. (9- problem flowing into storm water pond,
areas 15 tonnes/year) clean up would require cleaning of pond
Calibration of probes TOC- every 2 weeks,
Overflow of retention pH once/month. During calibration one of the
Overflow can lead to flow into river
Storm water pond due to retention ponds is held full. Potential instance
28 1 1 estuary outfall causing potential for high 1
retention pond inadequate capacity for spillage area washed down into storm
environmental costs
(worst case scenario) drain filling 2nd lagoon in addition to a fire
event on-site
Leakage from liner 2003 test of SWRP liner stated liner passed Potential ground and soil contamination if
Storm water leading to all checks (visually). Tested every 3 yrs. undetected between 3 year checks and
29 1 1 1
retention pond contamination of Annual visual checks undertaken- sub contaminated water is held in lagoon for
ground contractors required to repair if noted. Over long periods at a time
MDE0970Rp0013 33 Rev A01

Risk
Score
30 yr period, likelihood of lining to wear and
tear is moderate
High volume of solids containing acids left in
WWTP Potential leaks to soils/ All lines are double contained and now
sump, leading to corrosion. Problems for
36 underground groundwater/ from lift 1 1 drain into an outer tank with no 1
testing, patches in lining required to be
tanks station environmental impact.
replaced. 10m underground
Most vulnerable structure for reaction due to Constructed as a tank within a tank.
WWTP Potential leaks to
various substances in vessel, lining of Underground tanks leaking may go
37 underground soils/groundwater from 1 1 1
polymer, have had problems with integrity in undetected and lead to high investigation
tanks neutralisation tank
lining and clean up costs.
Floor sumps are sufficient to take minor
Category 8 warehouse is a controlled spills (1 x 200L drum). Large spill would
environment with only 1 trained forklift fill sump and migrate towards emergency
Category 8 on warehouse flow
43 1 operator at any time and no recorded 1 exits to the east of the warehouse. 1
warehouse leading to overflow and
incidence of spillages. Only non-flammable Material would be intercepted to SW
ground contamination
liquids located in this area. system and diverted to the Storm Pond
for containment.
Category 6 warehouse has a series of floor
Category 6
Major Spillage of liquid sumps capable of containing 110% of the
(flammable Major spill would be contained in Spill
44 in Category 6 storage 1 largest containment unit in the warehouse 1 1
material) 3 Basin 1 and treated in WWTP.
area (1m IBC). Any spill is now diverted directly
warehouse
to Spill Basin 1.
RVTM only used as back up to LVI
Redundant approximately 2 weeks per annum (4%) and
Low environmental impact as such a
Vapour Elevated emissions of typically for short durations of 4-5 days at a
47 1 1 short term discharge will dilute and 1
Treatment HCl time. Production altered to prevent Cl
disperse rapidly in the atmosphere.
Module (RVTM) compounds to unit. New scrubber installed
on RVTM in 2013.
In the event of a spill the drains would
discharge into the SW drainage system.
Breach of catchment In 2012 dosing chemicals (phosphoric acid,
No alert systems for these chemicals at
WWTP dosing tray used for urea, anti-foaming agent) installed in newly
49 1 1 the Storm Pond so no automatic 1
chemical storage secondary containment constructed bund adjacent to the
isolation. Potential to discharge to
of dosing chemicals neutralisation tank over hard standing area.
surface water but all material
biodegradable.
Hydrogen Chloride is supplied in a In the event of a No unscheduled d
Release of Toxic Unscheduled release
Manifolded Cylinder Pallet containing 6 discharge the primary concern is human
54 Gas (Hydrogen of HCl gas to 1 1 1
cylinders. Each MCP is protected from impact health. Once into the atmosphere the
Chloride) atmosphere.
by a protective cage. The potential for gas will dilute and disperse readily with
MDE0970Rp0013 34 Rev A01

Risk
Score
releases due to cylinder damage, in view of no residual impact.
the robust design, is thought to be small.
MDE0970Rp0013 35 Rev A01

5 RISK EVALUATION
Based on the risk analysis carried out in Table 4.3, the risks have been prioritised to identify the risks
with the highest profile and allow for prioritisation of risk treatment. The prioritised risks are presented
in Table 5.1.
The prioritisation in Table 5.1 indicates that the risks with the highest consequence rating relate to
fires in production (Risk ID 50), the main warehouse (Risk ID 51) and the tank farm (Risk ID 53). In
these cases the likelihood of the event is considered very low given the current controls but the
consequence of such and event is deemed moderate. This is due to the wide variety of impacts of
such events including air emissions, fire water generation, firewater containment and firewater
treatment. There is significant site infrastructure in respect of firewater containment and the option for
on-site treatment of contaminated firewater. This minimises the actual environmental impact.
In addition to the risk evaluation table in Table 5.1, a risk matrix has been developed to allow the risks
to be easily displayed. The consequence and likelihood ratings are used in the matrix with the level of
consequence forming the x-axis and the likelihood forming the y-axis. This matrix provides a visual
tool for regular risk reviews since the success of mitigation can be easily identified. The risk matrix is
displayed in Table 5.2.
The risks have been colour coded in the matrix to provide a broad indication of the critical nature of
each risk. The colour code is as follows:
Red These are considered to be high-level risks requiring priority attention.

Amber These are medium-level risks requiring treatment, but are not as critical as a red
coded risk.
Green These are the lowest-level risks and indicate a need for continuing awareness and
monitoring on a regular basis. Whilst they are currently low or minor risks, some have the
potential to increase to medium or even high-level risks and must therefore be regularly
monitored and if cost-effective mitigation can be carried out to reduce the risk even further
this should be pursued.
The Risk Matrix indicates that there are no risks in the red zone requiring priority treatment or in the
amber zone requiring treatment through mitigation or management action. This is as a result of the
ongoing risk management at the facility for EPA and COMAH requirements resulting is a site with a
low risk profile.
All other risks are located in the green zone indicating the need for continuing awareness and
monitoring on a regular basis. However, assessment of the green zone risks has indicated that a
number of these risks can be reduced through the implementation of mitigation measures. These risk
treatment measures should be adopted where considered cost-effective to further reduce the risks.
The Novartis Ringaskiddy Limited facility is well managed in terms of environmental controls, resulting
in a very low number of risks with high likelihood and only one risk with a high consequence. In cases
where hazards were identified as occurring on a regular basis, the severity of environmental damage
and remedial cost was generally found to be minor as a result of control measures integrated into daily
operations, site design and risk management on site.
In summary, of the 55 hazards identified in Table 3.3, 21 of these hazards are assigned a risk score of
> 2 and are assessed for risk treatment in Section 6 of this report. The remaining 34 hazards have a
risk score 2 and therefore considered minor risks and are not assessed for risk treatment in
Section 5 of this report.
MDE0970Rp0013 36 Rev A01

Table 5.1: Risk evaluation table
Risk ID Potential Hazards Likelihood Consequence Risk Score

1 Minor spillages of solvents from manifold connections 5 1 5
Manual leaks from tanks sampling points in Tank
17 5 1 5
Farm
Potential leakage from glycol storage
41 5 1 5
tank/connections into bund
32 Potential leaks Spill Basin 1 2 2 4
33 Potential leaks Spill Basin 2 2 2 4
35 Potential leakage from WWTP tanks 2 2 4
52 Fire in the Category 6 Warehouse 2 2 4
55 WWTP sulphuric acid bund failure 2 2 4
Leaks from failure of flange on tanks in Tank Farm
18 4 1 4
(gasket failing) valves breaking
39 Fuel tanks - Potential leakage/spillage to ground 4 1 4
50 Fire in a Production Building 1 3 3
51 Fire in the Main Warehouse 1 3 3
53 Fire in the Tank Farm 1 3 3
Misconnections of lines resulting in overflow of tanks
2 3 1 3
as a result of backfilling from manifold connections
6 Spillages of bio-degradable solvents in Production 3 1 3
Spillages of solvents- non bio-degradable in
7 3 1 3
Production
10 Solid/powder spillage in Production 3 1 3
Spillage In process non-biodegradable material (up to
11 3 1 3
300kg) in Production
40 Potential leakage/spillage to ground from Fuel Tank 3 1 3
Potential for contamination of cleaning solvents to
42 3 1 3
warehouse floor
3 Explosion of Hydrogenator in PB2 1 2 2
9 Risk of explosion 1 2 2
Potential for reaction of water sensitive materials
12 1 2 2
leading to explosion
14 Overturned tanker during vehicle movement on site 1 2 2
Failure of tanks over catchment basins, leading to
15 1 2 2
16 Failure of tanks over catchment basins 1 2 2
Accident from haulage vehicle transporting waste ash
24 1 2 2
& liquid waste
Build up for solid residue in still pot resulting in
27 1 2 2
exothermic reaction
Loss of integrity of stainless steel lines resulting in
30 1 2 2
31 Line integrity of double contained uPVC lines 1 2 2
Major Spillage of liquid to SB1 and failure/overflow of
45 1 2 2
SB1
Major Spillage of liquid to SB2 and failure/overflow of
46 1 2 2
SB2
Potential Failure of reaction vessels leading to
4 2 1 2
spillage of product
Seal failure in cyclosporine dryer, leading to release
5 2 1 2
of product
Potential for contaminated drums being exported for
25 2 1 2
recycling
Degradation of concrete lines leading to potential
34 2 1 2
38 Risks from leaking of fuel oil tank (into bund) 2 1 2
Storage of waste skips on gravel area and potential
48 2 1 2
for ground contamination
MDE0970Rp0013 37 Rev A01

Risk ID Potential Hazards Likelihood Consequence Risk Score

Failure of HVAC filter systems resulting in potential
8 1 1 1
release of lightly contaminated air emissions
13 Spillage of Materials from storage vessels 1 1 1
Failure of overhead lines/leaks in lines, leading to
19 1 1 1
20 Leaking/spillages between tanker and tanks 1 1 1
Overfill of tankers to rear of incinerator in loading
21 1 1 1
area
22 Burning of unauthorised material in incinerator 1 1 1
23 Exceedance in Dioxins ELVs 1 1 1
Potential for spillages/leaks of waste oil in process
26 1 1 1
areas
Overflow of retention pond due to inadequate
28 1 1 1
capacity (worst case scenario)
Leakage from liner leading to contamination of
29 1 1 1
ground
36 Potential leaks to soils/ groundwater/ from lift station 1 1 1
Potential leaks to soils/groundwater from
37 1 1 1
neutralisation tank
Major Spillage of liquid on warehouse flow leading to
43 1 1 1
overflow and ground contamination
44 Major Spillage of liquid in Category 6 storage area 1 1 1
47 Elevated emissions of HCl 1 1 1
Breach of catchment tray used for secondary
49 1 1 1
containment of dosing chemicals
54 Release of Toxic Gas (Hydrogen Chloride) 1 1 1
MDE0970Rp0013 38 Rev A01

Table 5.2: Risk Matrix
V. High 5
1, 17, 41
Likelihood High 4
18, 39
Medium 3 2, 6, 7, 10,
11, 40, 42
Low 2 4, 5, 25, 34, 32, 33, 35,

38, 48 52, 55
8, 13, 19, 20,

21, 22, 23, 3, 9, 12, 14,
V. Low 1 26, 28, 29, 15, 16, 24,
50, 51, 53
36, 37, 43, 27, 30, 31,
44, 47, 49, 45, 46
54
Trivial Minor Moderate Major Massive
1 2 3 4 5
Consequence
MDE0970Rp0013 39 Rev A01

6 RISK TREATMENT
During the review of the Environmental Liabilities Risk Assessment (ELRA) each risk has been
examined and changes to mitigation measures/operating conditions were assessed. Where mitigation
measures, which were recommended in the annual reviews from 2007 to 2014, have been
implemented successfully, the updated risk score is presented in Table 4.3. Where mitigation is in
development stage, no change to the risk score is applied. Only on completion of mitigation measures
will the revised risk scores be applied.
All key risks (i.e. those where the risk score is > 2) are assessed for current controls and possible
additional mitigation as presented in Table 6 .1.
Significant mitigation measures identified in the original ELRA were implemented in the period 2007 to
2014. The result of these capital projects has been a reduction in risk score and potential liability
estimates for a number of high score risks associated with the WWTP and Storm Water Retention
Ponds. It is evident from the updated risk matrix that Novartis Ringaskiddy Limited has been proactive
in mitigating risk at the site and has consistently reduced risk scores since commencement of the
ELRA process in 2007.
Novartis Ringaskiddy Limited successfully combines the ELRA with the site EMS and EMP. The site
environmental committee meets every two months and reviews the established EMP for the year.
Actionable items from ELRA are implemented in EMP and reviewed throughout the year.
Although the operation of the facility is unlikely to see any major changes in operation and controls,
there is potential however for processes and conditions to change. This assessment should therefore
be considered to be a live document and be reviewed in line with Condition 12.3.2 of the companys
IED licence.
MDE0970Rp0013 40 Rev A01

Table 6.1: Statement of Measures
Risk Risk Target Owner/Contact

Potential Risk Mitigation Measures to be taken Outcome Action
ID Score Date Person
Carry out training needs
Improve awareness Plant Manager
Minor spillages of solvents Training of staff and regular manifold analysis for all relevant
1 5 and response to Ongoing Technical
from manifold connections inspections staff and execute
such events. Services
refresher course.
Manual leaks from tanks Training of staff on correct closure Improve awareness Plant Manager
analysis for all relevant
17 sampling points in Tank 5 procedures. Regular testing of solvent and response to Ongoing Technical
staff and execute
Farm lines such events. Services
refresher course.
Potential leakage from Control measures are considered
41 glycol storage 5 adequate. Checked as part of integrity NA NA Ongoing Utilities Engineer
tank/connections into bund programme
Groundwater well installed (MW6) at Lift
Better detection of
Potential leaks Spill Basin Station in close proximity to Spill Basin 1
32 4 groundwater Completed. NA NA
1 to monitor and alert of any groundwater
contamination.
impact.
Potential leaks Spill Basin A submersible pump has been installed Reduced frequency
33 4 Completed. NA NA
2 in SB2. of standing water
Improved detection Plant Manager
Potential leakage from Tanks to be inspected as part of ongoing Include tanks in routine
35 4 of loss of tank Ongoing Technical
WWTP tanks routine maintenance. inspection program.
integrity. Services
Current controls are adequate with
Fire in the Category 6
52 4 revised containment measures recently NA NA NA NA
Warehouse
introduced in this warehouse.
Current controls meet COMAH
Increased
Requirements. Ensure MAPP is updated
53 Fire in the Tank Farm 3 environmental Completed NA NA
to ensure adequate environmental
protection.
protection measures are fully robust.
Leaks from failure of flange
on tanks in Tank Farm No mitigation measured recommended.
18 4 NA NA NA NA
(gasket failing) valves Current controls capture all leaks.
breaking
Training of staff to ensure tap is filled
over concrete plinth. Plinth can be lined Carry out training needs
Improve awareness
Fuel tanks - Potential to ensure oil is not leaking into ground analysis for all relevant
39 4 and response to NA NA
leakage/spillage to ground below. 2009 update: Concrete plinth staff and execute
such events.
examined and cleaned and plinth was refresher course.
lined in May 2007
55 WWTP sulphuric acid bund 2 Carry out annual vidual inspection of all Improve detection Updated routine Q2 2014 Plant Manager
MDE0970Rp0013 41 Rev A01

failure bunds to detect any defects. system maintenance checks. Technical

Services
Current controls are adequate based on
Fire in a Production the review of containment capacity
50 3 NA NA NA NA
Building identified in the production areas during
2012 and 2013.
Containment in Category 8 warehouse Known FWR
Fire in the Main does not meet 110% rule. Fire water risk containment
51 3 assessment should be reviewed to capacity for this Completed NA NA
Warehouse
assess containment capacities. area.
Misconnections of lines
resulting in overflow of Improve awareness
Training of staff for awareness. analysis for all relevant Technical
2 tanks as a result of 3 and response to Ongoing
staff and execute Services
backfilling from manifold such events.
refresher course.
connections
Spillages of bio- Training of staff on correct closure Improve awareness
analysis for all relevant Technical
6 degradable solvents in 3 procedures. and response to Ongoing
staff and execute Services
Production such events.
refresher course.
Training of staff to prevent occurrence of
spillages including the appropriate Carry out training needs
Spillages of solvents- non Improve awareness
handling of materials, clean up of analysis for all relevant Technical
7 bio-degradable in 3 and response to Ongoing
spillages and will focus on mopping up staff and execute Services
Production such events.
and removal as solid waste. refresher course.

Staff awareness training, inspections of Improve awareness
Solid/powder spillage in analysis for all relevant Technical
10 3 process drains and response to Ongoing
Production staff and execute Services
such events.
refresher course.
Training of staff to prevent occurrence of
spillages including the appropriate Carry out training needs
Spillage In process non- Improve awareness
handling of materials, clean up of analysis for all relevant Technical
11 biodegradable material (up 3 and response to Ongoing
spillages and will focus on mopping up staff and execute Services
to 300kg) in Production such events.
and removal as solid waste. refresher course.

Training of staff to ensure tap is filled Improve awareness
Potential leakage/spillage analysis for all relevant
40 3 over concrete plinth. and response to Utilities Engineer
to ground from Fuel Tank staff and execute
such events.
refresher course.
Potential for contamination Control measures are considered
42 of cleaning solvents to 3 adequate NA NA NA NA
warehouse floor
MDE0970Rp0013 42 Rev A01

7 QUANTIFICATION AND COSTING
7.1 IDENTIFICATION OF THE WORST CASE SCENARIO
Section 5 of this report presents the risk analysis for the Novartis Ringaskiddy Limited facility and
ranks all risks in descending order of risk score (refer Table 5.1).
The prioritisation in Table 5.1 indicates that the risks with the highest consequence rating relate to
fires in production (Risk ID 50), the main warehouse (Risk ID 51) and the tank farm (Risk ID 53). In
these cases the likelihood of the event is considered very low given the current controls but the
consequence of such and event is deemed moderate. This is due to the wide variety of impacts of
such events including air emissions, fire water generation, firewater containment and firewater
treatment. There is significant site infrastructure in respect of firewater containment and the option for
on-site treatment of contaminated firewater. This minimises the actual environmental impact.
Other major fires, such as in the Category 6 Warehouse (Risk ID 52), have a lower consequence
score due to the use of foaming suppressant as opposed to water which reduces the subsequent
clean up costs.
Given the solvent quantities stored on the tank farm compared to the production and warehouse
areas, the consequences of a fire in the tank farm (Risk ID 53) is considered the work case scenario
for the Novartis Ringaskiddy Limited facility and the financial provision for ELRA is based on this
incident occurring.
However, it should be noted that there are a number of associated risks that must also be considered
in such an event. In the event of a fire in the Tank Farm the contaminated firewater will be contained
in the relevant catchment followed by diversion through a stainless steel process line to the spill basins
and ultimately being contained in the storm water retention pond. As a result, each of the following
risks must also be considered as part of this scenario:
Risk ID 15 and 16: Failure of the tanks and the catchment basins leading to ground
contamination.
Risk ID 30: Failure of the stainless steel lines between the catchment basins and the spill
basins.
Risk ID 45 and 46: Potential overflow and major spillage of material from the spill basins.
Risk ID 32 and 33: Potential underground leaks of the spill basins.
Risk ID 28: Overflow of the storm water retention pond.
Risk ID 29: Breach of the liner leading to ground contamination under the pond.
Each of these associated risks is also considered as part of the worst case scenario costed in the
following section.
MDE0970Rp0013 43 Rev A01

7.2 QUANTIFICATION AND COSTING
The worst case scenario as described in Section 7.1 has been developed to allow for a meaningful
quantification of the potential costs that would be incurred following such an extreme event. The
assumptions that have been employed in this scenario are outlined in the following paragraphs.
It has been assumed that all tanks in the tank farm contain flammable liquids and the design pressures
of the steel tanks (primary containment) range from atmospheric to 6 bar while operating pressures
are up to 0.4bar. Tanks are maintained under positive pressure by bleeding nitrogen gas into the
headspace.
This scenario assumes a multiple tank failure and fire that includes all tanks in one catchment basin
(secondary containment). The UK Health and Safety Laboratory have reported estimated failure rates
for various tanks and the rate for a catastrophic failure of the large tank containing flammable liquids is
-5
1.6 x 10 per vessel year (i.e. one in one hundred thousand). The probability of a multiple tank failure
is dependent on whether the failure was caused by a common event such as plane strike or
-7
earthquake (2.2 x 10 per vessel year) or caused by a domino effect such as knock on fires (5.51 x
-6
10 per vessel year). For a robust costing it has been assumed that all tanks in the catchment are
breached in the fire regardless of the cause.
The Tank Farm is a restricted area under the COMAH Regulations and only EX rated equipment may
be used in the area reducing the potential for ignition. A Work Permit regime is in place for all works
carried out in the area.
There is a fully trained fire crew on site at all times that have been trained in the treatment of fires in
the tank farm. The estimated time for the fire crew to attend any fire in the tank farm is less than 10
minutes.
There are low and high level gas detectors located in the tank farm to allow for early detection of any
fire, the immediate cessation of any transfers to, from and within the tank farm and the on site fire crew
is alerted. There are two sprinkler lines - one filled with gas /bulbs and one dry active line. On
activation the sprinkler system provides a deluge of water (mixed with foam) to cool the tanks and
suppress the fire. Each catchment basin has a separate sprinkler system. The tank farm fire
suppression system is checked on a monthly basis by the fire officer.
The use of the rapid response on-site fire crew as well as the deluge from the sprinkler systems is
considered adequate to mitigate any potential risk of secondary effects in other catchments and it is
assumed that the fire is restricted to one catchment. Calculations undertaken as part of the COMAH
Safety Report indicate that in the event of a fire, the time for a tank containing the most volatile solvent
(tert-butyl methyl ether) to reach boiling point will be 9.2 minutes before the integrity of this tank is
compromised.
The catchment basin that contains the largest solvent volume is Catchment 6 (refer Table 3.1) which
3
stores 10 tanks with a combined capacity of 621.63m including various solvents and solvent waste as
listed below. It should be noted that incompatible liquids are not stored in the same catchments so the
impact of mixing incompatible liquids is not considered further in this assessment.
Isopropyl acetate
Acetone
Ethyl Acetate
Methanol
Solvent Waste
MDE0970Rp0013 44 Rev A01

3
Catchment 6 has a capacity of 170.013m through which the material will divert to the secondary
3
containment in Spill Basin 2 (162m actual volume) via a 150mm stainless steel process drain.
3
Spill Basin 2 has been designed to allow for pumping of excess material to Spill Basin 1 (299m actual
volume) when the online TOC analyser hits a trigger point. This material then discharges directly to
the WWTP. In the event of a fire some material may be diverted to Spill Basin 1.
There is also a 300mm high water overflow in Spill Basin 2 which forms part of the storm water
network and discharges straight to the Storm Water Retention Pond. In the event of a fire in
Catchment 6 the bulk of the fire water would be routed through this overflow and held in the Storm
3
Water Retention Pond (tertiary containment). The pond can hold up to 10,000m and has been
designed to meet the capacity of firewater required for a major catastrophic event on the site following
a detailed fire water retention study in 2009.
3
This scenario assumes that all tanks in Catchment 6 are full (621.63m ) at the time of the fire and the
majority of firewater is discharged through Spill Basin 2 to the Storm Water Retention Pond. It is
assumed that no solvent is lost through combustion or evaporation (as a conservative assessment). It
3
has also been assumed that up to 2,000m of firewater will be used to suppress the fire (both from the
3
sprinklers and the fire crew). This 2,621m mixture will quickly reach the capacity of the catchment
3 3
basin 170m and Spill Basin 2 (162m actual volume) and will be diverted from the overflow to the
Storm Water Retention Pond. Small volumes may be diverted to Spill Basin 1.
In normal operations, Novartis Ringaskiddy Limited would typically test the water and then divert to the
WWTP for treatment. Table 7.1 lists the principle solvents employed at the facility in 2013 along with
a note on whether these solvents are biodegradable and treatable in the WWTP. The solvent n-
Methylpiperazine is the only solvent employed at the facility that may not be treated in the WWTP.
However, this solvent accounts for less than 1% of the annual usage in 2013 and, as such, it is
assumed that the firewater mix from the tank farm on the whole may be adequately treated in the
WWTP.
Table 7.1: Solvent treatment feasibility at the WWTP
Solvent Biodegradable Treatable in WWTP

n-Heptane Yes Yes
3-Methyl-1-Butanol Yes Yes
Acetone Yes Yes
Acetonitrile Yes Yes
Cyclohexane Yes Yes
Ethanol denatured with Isopropanol Yes Yes
Ethanol denatured with Toluene Yes Yes
Ethyl Acetate Yes Yes
Glacial Acetic Acid Yes Yes
Isopropanol Yes Yes
Isoproply Acetate Yes Yes
Methanol Yes Yes
Methyl Ethyl Ketone Yes Yes
n,n-Dimethylformamide Yes Yes
n-Butanol Yes Yes
n-Butlyacetate Yes Yes
n-Methylpiperazine No No
t-Amyl Alcohol Yes Yes
tert-Butyl Methyl Ether Yes Yes
Tetrahyrdofuran Yes Yes
Toluene Yes Yes
MDE0970Rp0013 45 Rev A01

The costings assume a detailed site investigation will be carried out following the incident to confirm if
any ground contamination occurred during the event. It has also been assumed that given the
extensive containment on site and routine testing/maintenance no significant contamination will be
encountered and no remediation works will be required.
Given the number of conservative assumptions presented above, a robust worst case scenario has
been established for the site in the event of such an incident. Table 7.2 presents an estimation of the
costs associated with controlling, cleaning and investigating the pollution cased by this scenario. A
contingency of 10% has been added to the costing to ensure that any uncertainty in the assessment is
adequately covered.
MDE0970Rp0013 46 Rev A01

Table 7.2: Quantification and Costing of Worst Case Scenario
Measurement Unit Rate Cost

Task Description Quantity (No.)
Unit () ()
Fire fighting and Onsite Fire Services 1 day 0 0

containment Fire suppression consumables (foams, booms, etc.) 1 event 12,000 12,000
Removal of tank farm debris (contractor) 5 days 1,400 7,000
Removal of tank farm debris (transport) 10 loads 400 4,000
Removal of tank farm debris (disposal/recovery) 10 tanks 350 3,500
Decontamination of tank farm area 10 days 1,900 19,000
Drain jetting of stainless steel channel 100 metre 6 600
Clean Up Operation
Cleaning of Spill Basin 2 5 days 1,900 9,500
Cleaning of Spill Basin 1 2 days 1,900 3,800
Drain jetting of Spill Basin 2 Overflow channel to WWTP 500 metre 6 3,000
3
On site disposal of contaminated firewater in the WWTP 2621 m 0 0
Decontamination of SWRP 10 days 1,900 19,000
Site Investigation (Consultant Costs) 15 days 750 11,250
Trial pits at Catchment Basin 4 pits 100 400
Boreholes around Catchment Basin 4 boreholes 2,000 8,000
Site Investigation Boreholes at Spill Basin 2 1 boreholes 2,000 2,000
Boreholes at SWRP 8 boreholes 2,000 16,000
Soil testing (3 rounds) 12 samples 150 1,800
Groundwater Testing (3 rounds) 39 samples 150 5,850
Total () 126,700
Contingency (%) 10%
Total including contingency() 139,370
MDE0970Rp0013 47 Rev A01

8 CONCLUSION
The ELRA process follows the EPA guidance document entitled Guidance on assessing and costing
environmental liabilities 2014. This report updates the original ELRA prepared in 2007 and the series
of annual reviews of the ELRA every subsequent year since. This report presents the findings of the
ELRA review carried out in January 2014.
The 2014 review of the Environmental Liabilities Risk Assessment (ELRA) was undertaken during a
site visit to the Novartis Ringaskiddy Limited facility in order to review the operational conditions and
implementation of mitigation measures identified during previous annual risk workshops.
During the workshop the project risk register was reviewed in detail. Each hazard was examined and
changes to mitigation measures were assessed. An additional two risks were identified and added to
register for assessment. Where mitigation measures have been implemented successfully, a set of
revised risk scores have been applied.
The Financial Provision has been based on the combined risks that pose the worst case scenario.
This is the maximum liability that may be incurred at the facility and as such, financial provision for the
facility is calculated as 139,370 (including contingency) based on this event.
Novartis Ringaskiddy Limited is committed to ensuring the highest level of environmental performance
and environmental protection in its operations, and regards this as an integral part of its normal
business practice. Novartis Ringaskiddy Limited is a component site of Novartis AG. Novartis AG
operates a global network of manufacturing sites, including both bulk manufacture and final dosage
formulation facilities, together with logistics facilities, and technical support functions. Novartis AG, in
common with many large multinational companies, provides central funds to its operating units through
standard financial mechanisms.
Novartis Ringaskiddy Limited has submitted a Parent Company Guarantee (Appendix B) to the EPA
in respect of financial provisions for potential unknown liabilities, taking the outcome of this updated
ELRA into account. This guarantee will be reviewed and updated as necessary to reflect changed
circumstance or risk profiles on site as identified during the ELRA process.
MDE0970Rp0013 48 Rev A01

APPENDIX A
SITE LAYOUT MAP

APPENDIX B
PARENT COMPANY GUARANTEE

The following pages contain the companys Closure, Restoration and Aftercare Management
Plan (CRAMP), which was updated at the start of 2013. It outlines the measures to taken and/or
adopted at the site in relation to a partial or complete closedown of the facility.
Closure, Restoration and Aftercare
Management Plan 2014
DOCUMENT CONTROL SHEET
Client: Novartis Ringaskiddy Limited
Project Title: Closure Restoration and Aftercare Management Plan 2014
Document Title: Closure Restoration and Aftercare Management Plan
Document No: MDE0970Rp0013
DCS TOC Text List of Tables List of Figures No. of Appendices

This Document
Comprises:
1 2 40 - - 2
Rev. Status Author(s) Reviewed By Approved By Office of Origin Issue Date
A01 Final P. Chadwick C. Reilly C. Reilly West Pier 12/05/14
rpsgroup.com/ireland
Novartis Ringaskiddy Limited Closure, Restoration and Aftercare Management Plan
TABLE OF CONTENTS
EXECUTIVE SUMMARY........................................................................................................................ IV
1 INTRODUCTION ........................................................................................................................ 1
2 SITE EVALUATIION .................................................................................................................. 3
2.1 FACILITY OVERVIEW......................................................................................................... 3
2.2 OPERATOR PERFORMANCE .............................................................................................. 4
2.2.1 Environmental Management ............................................................................ 4
2.2.2 Compliance History .......................................................................................... 4
2.2.3 EPA Audit ......................................................................................................... 6
2.2.4 Complaints........................................................................................................ 6
2.2.5 Incidents ........................................................................................................... 6
2.3 ENVIRONMENTAL PATHWAYS AND SENSITIVITY .................................................................. 6
2.3.1 Groundwater..................................................................................................... 6
2.3.2 Surface Water................................................................................................... 7
2.3.3 Emissions to Sewer .......................................................................................... 7
2.3.4 Air Quality ......................................................................................................... 7
2.3.5 Human Beings .................................................................................................. 7
2.3.6 Natural Habitats and Protected Species .......................................................... 8
2.3.7 Environmental Pathways .................................................................................. 8
2.4 FACILITY PROCESS AND ACTIVITIES .................................................................................. 9
2.4.1 Production Buildings....................................................................................... 10
2.4.2 Tank Farm ...................................................................................................... 13
2.4.3 Solvent Recovery Unit .................................................................................... 15
2.4.4 Warehouses ................................................................................................... 15
2.4.5 Storm Water Retention Pond ......................................................................... 16
2.4.6 Waste Water Treatment Plant (WWTP) ......................................................... 16
2.4.7 Liquid Vapour Incinerator (LVI) ...................................................................... 16
2.4.8 Solid Waste Incinerator (SWI) ........................................................................ 16
2.4.9 Utility Building and Service Yard .................................................................... 16
2.4.10 Technical Services Building ........................................................................... 17
2.4.11 Waste Management ....................................................................................... 17
2.5 SITE INVENTORY ............................................................................................................ 17
3 CLOSURE TASKS AND PROGRAMME................................................................................. 23
3.1 CLOSURE CONSIDERATIONS ........................................................................................... 23
3.2 PROGRAMME TO ACHIEVE CLOSURE ................................................................................ 24
3.3 CLOSURE PLAN .............................................................................................................. 26
4 CRITERIA FOR SUCCESSFUL CLOSURE............................................................................ 33

5 CLOSURE PLAN VALIDATION .............................................................................................. 34
MDE0970Rp0013 i Rev A01

6 CLOSURE PLAN COSTING.................................................................................................... 35

7 CLOSURE PLAN UPDATE AND REVIEW ............................................................................. 38
8 COST SUMMARY .................................................................................................................... 39
9 CONCLUSION ......................................................................................................................... 40
LIST OF FIGURES
Figure 2.1: Overview of Materials Flow on site ..................................................................................... 10
Figure 2.2: Flow Diagram of Material Flow through Production Buildings ............................................ 12
Figure 3.1: Flow Diagram of Likely Order of Full Site Closure .............................................................. 25
Figure 3.2: Flow Diagram of Decommissioning of Production Buildings (Step 1)................................. 28
LIST OF TABLES
Table 2.1: Summary of Products Manufactured at Novartis Ringaskiddy Limited (2013) ...................... 3
Table 2.2: List of all licensed emission points and potential pathways ................................................... 9
Table 2.3: List of Site Buildings and Plant on Novartis Ringaskiddy Limited facility ............................. 18
Table 2.4: Tank Farm Inventory ............................................................................................................ 19
Table 2.5: List of solvent usage in 2013................................................................................................ 20
Table 2.6: Inventory of warehouses at the Novartis Ringaskiddy Limited facility ................................. 20
Table 2.7: Modules contained in WWTP system .................................................................................. 21
Table 2.8: Summary of 2013 Total Waste Arisings on Site (tonnes) .................................................... 22
Table 2.9: Breakdown of 2013 Hazardous and Non-Hazardous Waste Produced on Site (tonnes) .... 22
Table 3.1: Proposed use of WWTP Units.............................................................................................. 31
Table 6.1: Costing of closure of the Novartis Ringaskiddy Limited facility............................................ 36
Table 8.1: Future Cost Estimates for Closure of the Novartis Ringaskiddy Limited facility .................. 39
MDE0970Rp0013 ii Rev A01

APPENDICES
APPENDIX A Site Layout Map and Location of Monitoring Points
APPENDIX B Waste Inventory for 2013
MDE0970Rp0013 iii Rev A01

EXECUTIVE SUMMARY
Condition 10 of the Novartis Ringaskiddy Limited Industrial Emissions Licence (IEL, Register No.
P0006-03) requires the company to prepare a Closure, Restoration and Aftercare Management Plan
for the closure of the facility. RPS have reviewed the CRAMP in 2014 to update the costs and outline
any new developments at the facility. There is no known ground contamination at the Novartis
Ringaskiddy Limited facility and hence this plan is prepared and costed as a closure scenario with no
requirement for restoration or aftercare management.
The EPA guidance document entitled Guidance on assessing and costing environmental liabilities
2014 has been used as the basis for the methodology in preparing this report, hereafter referred to as
EPA 2014.
The closure aspect of the plan outlines the step by step approach to the planned tasks and programs
for the cessation of activity, the decontamination and decommissioning of the production facility and
ancillary services, the removal of all residual materials/fuels/wastes. In order to provide a robust worst
case costing it has been assumed that the closure of the plant will be an unplanned event and all tank
farms, warehousing etc. are full at the time of closure. In addition, it has been assumed that all tasks
will be carried out by third parties and not Novartis Ringaskiddy Limited personnel as a worst case
assumption.
MDE0970Rp0013 iv Rev A01

The calculated Financial Provision for the closure of the facility is 2,803,249 (exclusive of VAT). This
figure is based on a detailed analysis of the closure tasks and rates are based on existing suppliers
and industry norms. Where there is uncertainty in the task or program a conservative estimate has
been provided and a high level of contingency (20%) has been has been applied to the costing to
ensure a robust financial provision. Finally, all costs have been projected based on a 2% inflation rate
but no discounting has been applied and VAT has not been added.
Novartis AG provides central funds to its operating units through standard financial mechanisms.
Because of the likely lengthy interval between a decision to close the Novartis Ringaskiddy Limited
site and its actual closure, adequate time would be available to ensure that an allowance for central
funding would be incorporated into the site budget to implement the CRAMP.
MDE0970Rp0013 v Rev A01

1 INTRODUCTION
At the end of 2013, the IPPC licence (Register Number: P0006-03) was amended by the EPA to
conform with the provisions and requirements of Council Directive 2010/75/EU and as such is deemed
an IEL.
Condition 10 of the Novartis Ringaskiddy Limited IEL specifically refers to these requirements. These
specific conditions are quoted below:
Condition 10.2 Residuals Management Plan (RMP)
10.1.1 The licensee shall prepare, to the satisfaction of the agency, a fully detailed and
costed plan for the decommissioning or closure of the site or part thereof. This plan
shall be submitted to the Agency for agreement within six months of the date of grant
of this licence
10.1.2 The plan shall be reviewed annually and proposed amendments thereto notified to the
Agency for agreement as part of the AER. No amendments may be implemented
without agreement of the Agency
MDE0970Rp0013 1 Rev A01

Since 2006 RPS has prepared the Closure, Restoration and Aftercare Management Plan (CRAMP) in
conjunction with Novartis Ringaskiddy Limiteds site environmental management team. This report
presents the 2014 update of the CRAMP for the facility as per the requirements of Condition 10.2.2 of
the IEL.
2014 has been used as the basis for the methodology in preparing this report, hereafter referred to as
EPA 2014.
MDE0970Rp0013 2 Rev A01

2 SITE EVALUATIION
2.1 FACILITY OVERVIEW
Novartis Ringaskiddy Limited in Ireland was formed in March 1997 following the merger of Ciba and
Sandoz. Prior to this date, the facility operated under Sandoz from 1994 to 1997. Novartis
Ringaskiddy Limited manufactures a variety of pharmaceutical compounds by standard chemical
synthesis routes. Such synthesis and the related separation and purification steps are carried out in
standard chemical process equipment. The company also manufactures active substances through
application of purification procedures (rather than chemical synthesis).
Novartis Ringaskiddy Limited exported 393 tonnes of pharmaceutical drug substances in 2013 as
summarised in Table 2.1 below:
Table 2.1: Summary of Products Manufactured at Novartis Ringaskiddy Limited (2013)
Name Description
Asmex 03 This is an immediate precursor for the product Elidel (pimecrolimus), a non-steroid cream
developed for atopic eczema. A total of 3,034 kgs of Asmex 03 was shipped from the facility
during 2013.
Calcitonin This ingredient is sold as Miacalcic, which is a peptide that regulates calcium metabolism
and is mainly used in the treatment of osteoporosis. It is one of the companys low volume,
high value products with a total of 0.1 kg shipped during 2013.
Clozapine Clozapine is an antipsychotic agent that is exceptional in terms of the virtual absence of
severe side effects which are usually observed with other antipsychotic agents when used
for long term treatment. It is also particularly effective with patients who do not respond
to standard medicines. The final formulation is sold as Leponex/Clozaril and a total of
1,120 kgs of Clozapine was shipped from the facility during 2013.
Cyclosporine This is the active ingredient of Sandimmun a drug used in the prevention of transplant
rejection. Neoral is an advanced, microemulsion formulation of Cyclosporine and is the
most commonly used primary immunosuppressant after largely replacing its predecessor
Sandimmun. Some 29,455 kgs of Cyclosporine was shipped from the company during
2013.
Darifenacin Darifenacin is the active drug substance in Emselex a once-daily oral treatment for
overactive bladder. This product was approved in the European Union and the United States
in 2004 and has been shown to reduce the number of weekly urge urinary incontinence
episodes by up to 83% versus placebo. A total of 3,969 kgs of Darifenacin was shipped from
Novartis Ringaskiddy Limited during 2013.
Diovan Diovan (or Valsartan) belongs to the class of blood pressure-lowering medicines known as
angiotensin II receptor blockers (ARBs). It is the most prescribed brand in the ARB class of
compounds. Diovan accounted for approximately 69% of all drug substances shipped from
Novartis Ringaskiddy Limited during 2013 representing some 271,429 kgs.
Fluvastatin This is sold as Lescol and as Lescol XL in an extended release formulation and is a drug
that is used in the treatment of high cholesterol levels. Fluvaststin accounted for
approximately 7% of all drug substances shipped from Novartis Ringaskiddy Limited during
2013.
Glivec Glivec has clinical indications in the treatment of chronic myeloid leukaemia (CML) and
gastrointestinal stromal tumours. It is one of Novartis Ringaskiddy Limited Pharmas flagship
oncology products and Novartis Ringaskiddy Limited is the main manufacturing facility for this
life saving medicine. A total of 41,777 kgs of Glivec was shipped from the facility during
2013.
Ketotifen This is the active ingredient of Zaditen, an oral asthma prophylactic and anti-allergic that is
Hydrogen used in the treatment and prevention of paediatric asthma, allergic skin diseases (atopic
Fumarate dermatitis and urtiaria) and allergic rhinitis (hay fever). A total of 574 kgs of this substance
MDE0970Rp0013 3 Rev A01

Name Description
was shipped from the facility during 2013.
Indacaterol 84 kgs of Indacaterol Maleate was shipped from the facility during 2013 for commercial use.
Maleate This drug substance is used in the commercially available product Onbrez/Arcapta, which is
used for the treatment of chronic obstructive pulmonary disorder (COPD). COPD is a chronic,
progressive respiratory condition characterized by gradual airway obstruction, shortness of
breath, cough and sputum production.
Octreotide This product is sold as Sandostatin, which mimics another peptide that regulates growth
processes. Two variants of Octreotide are produced at Novartis Ringaskiddy Limited, one of
which uses state-of-the-art technology to assemble the Octreotide molecule. It is another one
of the companys low volume, high value products with a total of 68 kgs shipped during
2013.
Pasireotide 15 kgs of Pasireotide Diaspartate was shipped from the facility during 2013 for commercial
Diaspartate use. This drug substance is used in the commercially available product Signifor, which is
used for the treatment of adult patients with Cushing's disease for whom pituitary surgery is
not an option or has not been curative. Cushing's disease most commonly affects adults as
young as 20 to 50 years and affects women three times more often than men. It may present
with weight gain, central obesity, a round, red full face, severe fatigue and weakness, striae
(purple stretch marks), high blood pressure, depression and anxiety. Cushing's disease can
cause severe illness and death with mortality up to four times higher than in the healthy
population.
Rivastigamine Rivastigmine is the active ingredient of Exelon and the transdermal system Exelon Patch.
Rivastigmine is a cholinesterase inhibitor indicated for the treatment of Alzheimers disease
(AD) dementia and Parkinsons Disease (PD) dementia. A total of 1,349 kgs of Rivastigamine
was shipped from the facility during 2013.
Ruxolitinib 244 kgs of Ruxolitinib Phosphate was shipped from the facility during 2013 for commercial
Phosphate use. This drug substance is used in the commercially available product Jakavi. Jakavi is
indicated for the treatment of disease-related splenomegaly or symptoms in adult patients
with primary myelofibrosis (also known as chronic idiopathic myelofibrosis), post
polycythaemia vera myelofibrosis or post essential thrombocythaemia myelofibrosis.
Terbinafine This is the active ingredient in Lamisil. In fungal nail infections (onychomycosis), nails can
become discoloured or thickened and even splinter as dermatophyte fungi attack the nail
plate, nail bed or nail matrix. Terbinafine accounted for approximately 4% of all drug
substances shipped from Novartis Ringaskiddy Limited during 2013, which represents 14,404
kgs.
2.2 OPERATOR PERFORMANCE
2.2.1 Environmental Management
Novartis Ringaskiddy Limiteds Environmental Management System and its environmental

performance is reported on to the public in accordance with the Community Eco-Management and
Audit Scheme (EMAS) (Registration Number IE - 002) as required under Regulation 1221/2009.
Novartis Ringaskiddy Limited has recently completed sixteen years of continuous participation in
EMAS. Novartis Ringaskiddy Limited was the first Irish company in the Chemical/Pharmaceutical
sector to register under the scheme. During the EMAS audit of December 2013 no non-conformances
were issued to Novartis Ringaskiddy Limited by the auditors. The next EMAS audit is due in June
2014.
2.2.2 Compliance History
The following is a summary of the compliance status of the Novartis Ringaskiddy Limited facility
MDE0970Rp0013 4 Rev A01

In 2011, the Solid Water Incinerator (SWI) demonstrated 100% compliance in terms of ELVs (10
minute; 30 minute; 24 hour means). Similarly mass discharges of all parameters (10 minute; 30
minute; and 24 hour means) were in 100 % compliance. Dioxin and dibenzofuran; hydrogen fluoride
and hydrogen bromide; and metal emissions were in 100 % compliance.
In 2012 there were five noted breaches of the CO emission limit on the SWI (30 min average). An
investigation was carried out by Novartis Ringaskiddy Limited management and identified the source
of the breaches as fibre waste containers which have a high calorific value resulting in high CO levels.
Waste management practices have been altered at the site to ensure this waste stream is prohibited
from entering the SWI in future events.
In 2013, the SWI demonstrated 99% compliance, with three noted breaches of the CO emission limit
on the SWI (30 min average). An investigation was carried out by Novartis Ringaskiddy Limited
management and identified the source of the breaches as an off-set on the CO analyser needed to be
reset to its normal operational position following QAL2 validation. The primary cause of the third
breach was the introduction of two lots of solid waste rather than one which resulted in a short-term
reduction in oxygen concentrations that resulted in the generation of CO.
In 2011, the Liquid Vapour Incinerator (LVI) demonstrated 100% compliance in terms of ELVs (10
minute; 30 minute; and 24 hour means), with the exception of two twenty-four hour (concentration)
means for Hydrochloric Acid; one twenty-four hour (concentration) mean for particulates (Dust); and
one thirty-minute (concentration) mean for Carbon Monoxide. Mass discharges of all parameters (10
minute; 30 minute; and 24 hour means) were in 100 % compliance, with the exception of one thirty-
minute mean for Particulates (out of a total of 17,449 readings). Dioxin and dibenzofuran; hydrogen
fluoride and hydrogen bromide; and metal emissions were in 100 % compliance. In 2013, daily mass
discharges of all parameters demonstrated 100% compliance with the requirements of the IEL.
Emissions from the waste water treatment plant demonstrate 100% compliance with the ELVs of the
licence in 2011, with the exception of Total Ammonia which demonstrated 98% compliance (Non-
compliance 1 out of 52 readings). In April 2012, two further deviations from the ELVs were noted for
ammonia in this discharge. A rapid route cause investigation was carried out by Novartis Ringaskiddy
Limited management and identified the source of the breaches in the production process. A
subsequent corrective action procedure has been put in place to modify the process and prohibit
further breaches. In 2013, emissions from the waste water treatment plan demonstrated 100%
compliance with the ELVs, with the exception of Total Suspended Solids and Chemical Oxygen
Demand, which demonstrated 97% compliance (Non-compliance 10 out of 365 readings) and 89%
compliance (Non-compliance 41 out of 365 readings) respectively. A rapid Root Cause Investigation
was carried out by Novartis Ringaskiddy Limited management over a number of weeks and identified
the root cause as the use of a new sanitising agent in some of the production clean rooms, which was
introduced at a time when the WWTP was operating on one aeration basin. A number of continuing
corrective actions were implemented.
Noise levels at the boundary of Novartis Ringaskiddy Limited were demonstrated to be compliant with
the requirements of IEL Register Number P0006-03 during the annual sound level surveys between
2004 and 2013.
The quality of the groundwater beneath the facility has remained the same as that established prior to
the commencement of the development at Novartis Ringaskiddy Limited.
All surface water leaving the site was monitored, found to be of an acceptable quality for discharge
and conformed to the requirements of IEL Register Number P0006-03.
MDE0970Rp0013 5 Rev A01

2.2.3 EPA Audit
rd
The EPA carried out an audit of the Novartis Ringaskiddy Limited facility on the 23 April 2013. The
EPA issued one non compliance to the facility relating to the following:
Bund register incomplete include the mobile bunds and bulk storage trailer park as part of
the catchment area for spill basin 1.
This non-compliance was addressed to the satisfaction of the EPA. A total of thirteen observations
were also issued following the audit and were addressed to the satisfaction of the EPA.
2.2.4 Complaints
In 2013, two complaints (one noise and one odour) made directly to Novartis Ringaskiddy Limited and
the EPA by one individual. Both complaints were investigated by the company and both the EPA and
the complainant were updated on the outcomes of the investigations. The company evaluated that
there was no significant adverse environmental impact associated with these complaints.
2.2.5 Incidents
In 2013, Novartis Ringaskiddy Limited did not report any major incident to the EPA during 2013. Fifty-
four readings out of a total of more than 228,000 were judged to be in non-compliance and were
reported to the EPA. All non-compliances were judged to be minor deviations and did not present the
Elevated 30-min mean CO from the SWI (3 in total)
Elevated Suspended Solids from the WWTP (10 in total)
Elevated COD from the WWTP (41 in total)
Each of these incidents was considered minor with no significant damage to the surrounding
environment.
2.3 ENVIRONMENTAL PATHWAYS AND SENSITIVITY
2.3.1 Groundwater
As part of the sites IEL, emissions to groundwater are monitored on a bi-annual basis at four
groundwater monitoring wells (MW-1, MW-2, MW-3 and AW-6) all located within the grounds of the
facility. The locations of the wells have been chosen to represent the most vulnerable areas down
gradient of groundwater flowing throughout the site.
In late 2010 a new groundwater well (MW6) was installed beside the lift station for the wastewater
treatment plant. This well was recorded as dry in 2011 but subsequent monitoring in 2012 and 2013
has yielded groundwater.
Monitoring parameters are as per Schedule C6 of the licence. The quality of groundwater is assessed
in terms of the drift in quality between ambient baseline determined before the facility commenced
operation. Monitoring to date at these wells up to 2013 has not resulted in any change in quality when
MDE0970Rp0013 6 Rev A01

compared to baseline quality levels when manufacturing activities commenced at the facility. This
indicates that there has been no observed impact to groundwater quality from the facilitys operation.
2.3.2 Surface Water
Surface water is collected through a series of storm water drain networks around the site from building
roofs, roads and all hard standing areas. The storm water drains flow directly via a buried gravity drain
into the storm water retention pond located in the south west of the site and out to the Cork County
Council storm water sewer. Water flowing into the retention pond is monitored using a continual water
chemical monitoring system to check compliance with water quality levels suitable for discharge into
the storm water sewer. The system checks levels of pH and Total Organic Carbon (TOC) the levels of
which are fed back to the Environmental Controls Department (ECD). Monitoring of the surface water
discharge has shown full compliance in the Annual Environmental Reports (AER) to-date. The storm
water drainage network is inspected as part of the three-yearly programme of testing and inspection of
underground pipes.
2.3.3 Emissions to Sewer
Novartis Ringaskiddy Limited operates an enclosed wastewater treatment plant (WWTP) that is used
to treat lightly contaminated water that is used in processing activities, in addition to sanitary
wastewater. The effluent is treated by a mixture of physical and biological treatment before being
discharged to the Local Authoritys (Cork County Council) marine outfall pipeline. This pipeline
services a number of local towns and industries and discharges in deep water in the outer section of
Cork Harbour.
2.3.4 Air Quality
Emissions to atmosphere are from four main emission points on the site as follows:
Solid Waste Incinerator (SWI, Emission Point No. 3).
Liquid Vapour Incinerator/Vapour Treatment Module (LVI, Emission Point 4).
Two natural gas boilers.
Both incinerator are equipped with CEMS and operate within the stringent controls set out in Schedule
C.1.1 and emission limits set out in Schedule B.1 of the IEL. The total quantities and waste streams
that are permitted for disposal in each of the SWI and LVI are restricted to the limits presented in
Schedule A of the IEL. One of the principle restrictions on material being combusted in the
incinerators is a <1% organohalogen content as specified in Schedule A.2 Table A.2 Waste
Categories for disposal by incineration on-site.
2.3.5 Human Beings
The location of the Novartis Ringaskiddy Limited site is situated northwest of the village of Ringaskiddy
within IDA industrial estate grounds.
MDE0970Rp0013 7 Rev A01

The nearest residential receptors to the site boundary are located adjacent to the western site
boundary. The distance between site buildings and activities are approximately 200-300m from the
nearest properties.
The operation of the site will be most noticeable in terms of noise emissions and potentially from
odours. Noise levels are monitored as part of the sites IEL on an annual basis. This includes
measurements at the sites boundary and at the nearest noise sensitive locations. The facility must
comply with noise emission limits of 55dB LAeq during day time hours and 45dB LAeq during night time
periods. The operation of the Novartis Ringaskiddy Limited site has shown full compliance with these
day and night time licence limits to date. Odours are controlled through ventilation systems on the
WWTP and enclosed venting systems leaving the production buildings to the liquid vapour incinerator.
2.3.6 Natural Habitats and Protected Species
Under the definitions of the Environmental Liability Regulations, damage to natural habitats and
protected species means any damage that has significant adverse effects on reaching or maintaining
the favourable conservation status of certain habitats or species. The species and habitats covered
are those listed in Annex I of the Birds Directive (79/409/EEC) and Annex I, II or IV of the Habitats
Directive (92/43/EEC).
Novartis Ringaskiddy Limited has been carrying out annual bird surveys at the facility since 2007 to
monitor local biodiversity with results published in the annual environmental statements. The most
recent survey was carried out in 2013 and no Annex I species are identified on the site.
The nearest designated ecological site to the Novartis Ringaskiddy Limited facility is the Cork Harbour
Special Protection Area (SPA Site Code 4030). The SPA site comprises most of the main intertidal
areas of Cork Harbour, including all of the North Channel, the Douglas Estuary, inner Lough Mahon,
Lough Beg, Whitegate Bay and the Rostellan inlet. The nearest point to the Novartis Ringaskiddy
Limited facility is the Lough Beg estuary approximately 700 metres east of the facility boundary.
Given the remote nature of the designated habitats and the absence of protected species on the site,
the potential for impacts to these ecological receptors is low.
2.3.7 Environmental Pathways
Table 2.2 provides an inventory of all licensed emission and monitoring points at the Novartis
Ringaskiddy Limited facility. Also presented is the potential pathway and impact from these sources.
MDE0970Rp0013 8 Rev A01

Table 2.2: List of all licensed emission points and potential pathways
Reference Description Licence Potential Pathways and Impacts

Conditions
EP01 Natural gas boiler NA Human health and ecosystems.
EP02 Natural gas boiler NA Human health and ecosystems.
EP03 Solid Water Incinerator Limits B.1 Human health and ecosystems.
Controls C.1.1
Monitoring C.1.2
EP04 Liquid Vapour Incinerator Limits B.1 Human health and ecosystems.
(and RVTM)
Controls C.1.1
Monitoring C.1.2
EP05 Emergency Generator NA Human health and ecosystems.
EP06 Pump house generator NA Human health and ecosystems.
EP07 Pump house generator NA Human health and ecosystems.
EP100 Discharge from WWTP Limits B.3 Cork County Council Sewer and ultimately
marine outfall in Cork Harbour water and
Controls C.3.1 ecosystems.
Monitoring C.3.2
W 01 Wastewater from Limits B.3 Cork County Council Sewer and ultimately
incineration activities prior marine outfall in Cork Harbour water and
to mixing with other effluent Monitoring C.3.2 ecosystems.
(EP 100).
SW1 Storm water emission Monitoring C.2.3 Surface water and ecosystems
MW1 Groundwater Monitoring C.6 Groundwater, soils
AW6 Groundwater Monitoring C.6 Groundwater, soils
2.4 FACILITY PROCESS AND ACTIVITIES
The facility at Novartis Ringaskiddy Limited is designed for flexible batch processing with two major
process buildings, termed Production Building 1 (PB1) and Production Building 2 (PB2). PB1 also has
its own synthesis annex termed PB1A. The production buildings are used for chemical processes
such as alkylation, condensation, salt extraction, distillation and separation. The synthesis Annex is
equipped for low temperature and water sensitive processes and also catalytic hydrogenation. Raw
materials are held in the tank farm and storage warehouses and fed into the production buildings on
an as need basis. All waste materials are either extracted via vent hoods or hard piped to the liquid
vapour incinerator (gas and solvent wastes), into the solvent recovery unit (solvent waste) for
recycling, or segregated and recycled or incinerated in solid waste incinerator (solid waste).
A Small Scale Production plant was built and commissioned in 2008. The process undertaken is low
volume, high value. The process is integrated into the existing effluent treatment and air abatement
systems and there are no significant additional emissions or hazards associated with the new building.
MDE0970Rp0013 9 Rev A01

A summary of processes and material flows within the facility is set out in Figure 2.1. A full inventory
of all buildings and structures on the site are provided in Table 2.3 and a site layout map is presented
in Appendix A.
Figure 2.1: Overview of Materials Flow on site
Raw Solvents
Materials
Category Tank Farm Solvent Recovery

Warehouses
Lay-down
Production Building Production Building 1

2 (PB2) (PB1) and PB1A
SSF Associated with
PB1
Products Environmental Controls Module Products
Each of the identified areas has inherent environmental risks associated with them. A brief description
of each of the areas and a summary of their processes are included in the following sections.
2.4.1 Production Buildings
There are three main production buildings on the Novartis Ringaskiddy Limited site, which perform a
variety of operations required for the manufacture of bulk pharmaceutical actives, a summary of the
processes undertaken within the production buildings are outlined below and summarised in Figure
2.2.
Production Building 1 (PB1): This is a seven story process building which contains a variety of multi-
purpose equipment ranging from reactors, crystallisers and separators, solid/liquid separators, driers,
evaporators and a range of auxiliary equipment which flow from top floor down. The production lines
can be configured for different production trains as required and the plant is capable of coping with all
standard processes required to produce fine chemicals.
Production Building 2 (PB2): This is a seven story process building which contains a variety of
equipment such as separators, reactors, crystallisers, dissolvers or various sizes, solid/liquid
MDE0970Rp0013 10 Rev A01

separators, driers, evaporators and a range of auxiliary equipment from top floor down. Equipment
within this building is used predominately for the same family of products, predominately Diovan and
Cyclosporine. The equipment is capable of being configured for different production trains however,
this occurs on a less frequent basis.
Production Building 1A (PB1A): This is a four story building used for process steps where a higher
degree of safety and environmental protection is required. The use of water reactive chemical
substances, hydrogenation, and low temperature reactions are all undertaken in this building. Much of
the equipment housed in this building is similar to that contained in PB1 and PB2.
The three buildings have been designed in order to contain any releases of substances within the
manufacturing process, in addition procedures are set down in order to minimise the potential for
environmental risks, and these include:
Process floor drains throughout the buildings flow directly into process drains. These drains
flow into the sites WWTP lift station, but can alternatively be diverted into Spill Basin 1 in the
event of a large spillage or release of liquids with high solvent concentrations.
All production trains in the production buildings are linked to the Liquid Vapour Incinerator
(LVI) for the purpose of vapour and off-gas treatment.
HVAC system in production buildings circulate air exchange, filters are replaced on regular
basis by dedicated team.
Containment suites are used for high category substances.
Raw materials are brought in on a strict requirement basis to avoid stockpiling within
production buildings.
Similarly, waste materials are suitably labelled and removed to designated storage areas post
generation.
Full clean down of vessels and equipment on regular basis.
Figure 2.2 provides an outline of the vertical processes within a typical production building
from top floor material input to ground floor product out.
The Small Scale facility (SSF) plant is located north of Production Building 1A. The SSF was
commissioned during 2008/09 and is now used for the manufacture of certain low volume high value
product. It is a relatively small two-storey building of modular design that will allow incorporation of
additional modules as required.
MDE0970Rp0013 11 Rev A01

Figure 2.2: Flow Diagram of Material Flow through Production Buildings
Top Floor
Liquids Charging Liquid
Filters Solids Charging
Vessels Vessels
Pumps
Separators Separators Liquids Solids Solids

Charging
Dryers / mill/ blenders Vessels
Dryer Unloading Pumps
Raw
Ground Floor Material
Products
MDE0970Rp0013 12 Rev A01

2.4.2 Tank Farm
This area is located to the north of the site and is used for the bulk storage of liquids, principally
solvents, which are directed into production buildings via overhead pipelines. Un-reusable and un-
recyclable waste solvent and process liquids awaiting incineration are stored in this area also. The
3
Tank Farm consists of 100 tank compartments with capacities ranging between 25 to 100m with a
3
total storage capacity of 3,200m .
The tank farm is bunded to contain any spillages and incompatible liquids are bunded separately. The
majority of materials stored in the tank farm are compatible. The notable exceptions are acetic acid
and sodium hydroxide (caustic) which are deliberately stored in tanks located in separate catchment
areas.
The primary bunds on site are operated on the basis of catchment areas, in so far as if a spill from a
tank occurs then the liquid is drained away from the tank area and directed to a remote storage bund
in either in Spill Basin 1 or Spill Basin 2. This procedure is in place in order to direct any flammable
liquid that may have leaked from a tank away from the remaining liquid being stored within the
catchment area.
Following an EPA audit in 2012, a series of recommendation were made in relation to the storage and
transfer of materials including the tank farm area, spill basins. A range of infrastructural changes were
implemented by Novartis Ringaskiddy Limited in these areas including the following:
Modifications to Spill Basins 1 and 2 to increase the capacities of both basins for compliance
with EPA guidance.
Modification to Spill Basin 2 to ensure that liquid is kept to the minimum level.
Installation of a conductivity probe in the Tank Farm Area to detect a leak of Sodium
Hydroxide. This compliments the existing LEL (lower explosive limit) detectors, which are used
to detect a leak of solvent.
These works have been fully implemented by the Novartis Ringaskiddy Limited team to reduce the risk
of incident at the facility. The current capacities of the infrastructure are presented below:
3
Spill Basin 1 has an actual volume of 299m and is located adjacent to the Wastewater Treatment
Plant and caters for the following bund/catchment areas:
Tank Farm Catchment Basins No.1, 2, 3, 4 and 5

Truck Unloading Area.
Solvent Recovery Area (East)
Bulk Storage Trailer Park
Pumped Discharge from Spill Basin 2
Warehouse No. 6
If any release of liquid is discharged to Spill Basin 1 then it is collected within the basin where it is
assessed and then pumped to the Wastewater Treatment Plant where possible. The Bulk Storage
Trailer Park has an overall capacity for fifteen Road Tankers, however it would be very unusual for all
the spaces to be occupied at the same time. Of the 15 spaces, there are 3 that are permanently
3
occupied by three 26m tankers (at the slow fill arms) while the remaining 12 other spaces cater for
3
trailers with a capacity of 20m . The average number of road tankers stored in these spaces would be
MDE0970Rp0013 13 Rev A01

6 to 7 but for the purpose of the bund capacity assessment all spaces are conservatively assumed as
occupied.
3
Spill Basin 2 has an available volume of 162m and is located adjacent to Catchment Basin No.7 and
caters for the following catchment basins:
Tank Farm Catchment Basin No. 6, 7, 8, 9 and 10.
The water level within Spill Basin 2 is kept to a minimum as a result of the installed low level outlet to
the surface water drain. In the event that the outlet valve is closed then the collected liquid is
automatically pumped to Spill Basin 1, which ensures that the water level in Spill Basin 2 is kept to the
minimum level which ensures that the maximum storage volume is maintained within Spill Basin 2.
Spill Basin 2 has been designed to pump any collected liquid directly into Spill Basin No.1. The
3
combined capacity of the two spill basin amounts to 461m . In the highly unlikely event that all tanks
failed in the above catchment basins, the liquid would discharge to the Storm Water Retention Pond
via the overflows in each spill basin.
A full review of the capacities of all bunding on site was carried out by Arup Consulting Engineers in
2013 and the relevant reports have been issued to and approved by the EPA. This review was carried
out to determine the compliance levels of all bunds with the EPA guidance as follows:
Containment bunds that cater for a single tank shall have a capacity equal to 110% of the
capacity of the tank.
Containment bunds that cater for more than one tank shall have a capacity of 110% of the
largest tank or 25% of the capacity of all the tanks whichever is the greater.
The following were the primary conclusions of this assessment:
Both Spill Basin No.1 and 2 can cater for liquid from either a single tank or multiple tank failure
within an individual catchment for both the 110% and 25% rule.
In a the unlikely catastrophic event of multiple tanks failing in multiple catchments basins then
liquids will discharge to both Spill Basins and any excess volumes will discharge to the Storm
3
Water Retention Pond which has a capacity of circa 10,000m storage. This scenario has
been the subject of a separate risk assessment that has been submitted to the EPA.
As a recommendation for site safety under the COMAH Regulations, Novartis Ringaskiddy Limited
propose to install a series of three gullies along the tank farm road to the south of the tank farm in
early 2014. The purpose of the gullies is to provide a mechanism of tertiary containment in the event
of a tank failure and subsequent bund overtopping. The natural gradient in the area is a southerly flow
towards the production buildings and the gullies will contain any overtopping at the tank farm road and
prevent the possibility of a flow of material to production causing a domino effect.
Another recommendation for site safety under the COMAH Regulations in the ECD area and the
construction of a 2.1 metre high wall between the above ground installation (AGI) and the slow fill
area. This wall will provide a physical barrier against any potential gas jet fire from the natural gas AGI
causing damage to a road tanker at tanker slow fill (or pool fire causing a gas explosion).
Table 2.4 provides a full inventory of the ten separate catchments in the tank farm, the relevant spill
basin and the number and type of tanks in each catchment. Table 2.5 provides details of the solvent
usage for the last calendar year (2013).
MDE0970Rp0013 14 Rev A01

2.4.3 Solvent Recovery Unit
This area is located to the north east of the site and is involved in the recovery by distillation of
solvents from the processes. The unit consists of 15 distillation columns with still pots of varying
capacity. Solvents awaiting recovery and recovered solvents are stored in the main Tank Farm.
The recovery unit is bunded to contain any spillages. The capacity of each bund is not less than 110%
of the largest tank. All bunded areas or containment tanks are directly linked to the process flow
drains, which flow directly into a designated spill basin.
2.4.4 Warehouses
A variety of storage warehouses are located within the Novartis Ringaskiddy Limited grounds, mostly
towards the east of the site. These are used for separate storage of raw materials, products and
intermediates. Each warehouse contains substances classified by their storage category using the
Novartis Corporate HSE warehouse guidelines. These segregate goods on their physical, ecological
and toxicological properties and their combustion properties. The design of each warehouse inclusive
of the layout, density of stock, fire control and other specific contingency arrangements are related to
the nature of the stored goods.
The Category 6 Warehouse is located to the north of the site adjacent to the Tank Farm. This
warehouse is used for the storage of flammable materials in containers typically of the order of 200
litres; although large IBCs of up to 1,000 litres can also be stored in this area. The warehouse has a
3
capacity to store 94.76m of materials (refer Arup Report Storm Water Protection Concept, March
3
2013). Allowing for the 110% rule the warehouse has a storage requirement for 1.1m (110% of pallet
3
storage volume) and based on the 25% rule the warehouse has a requirement to store 23.69m of
3
liquid. Given that the existing bund capacity in the warehouse is only 4.707m , the engineering review
concluded that connecting the existing open channels/bund directly to the process drainage network at
two locations from the warehouse was the optimum approach to ensure containment. In addition, leak
detection has also been installed within the open channels to provide an early warning system of any
uncontrolled discharge. This work has been completed and Warehouse 6 has now been integrated
into the bunded process network that drains to Spill Basin 1 (remote bund).
The Category 8 warehouse is located within the main warehouse and is used for the storage of non-
3
flammable materials with a capacity of 47.408m of material. The area is bunded with a series of floor
sumps to collect small scale spillages of up to one full container (e.g. a 200 litre container) with a
3
capacity of 4.61m . As such, the Category 8 warehouse does not currently comply with the 25% rule
3
and in the event that greater than 4 pallets (4m ) of material spilled then there would be a overspill of
containment. In such a scenario, the sumps would overflow and the material would drain to the SW
drainage network on the external areas of the warehouse and drain to the Storm Water Retention
Pond. Novartis Ringaskiddy Limited are currently carrying out a risk review to determine the potential
risk of more than four pallets spilling simultaneously.
During 2013 a number of operational controls have also been introduced for the warehouse:
The warehouses have been upgraded to replace the existing racking.
Liquid materials can no longer be stored above ground level.
SAP control systems have been implemented to reduce the risk of operations.
As a result, the potential for incident in the warehouses is reduced and the subsequent impact of a
discharge from the Category 6 warehouse is also reduced due to the improved containment.
MDE0970Rp0013 15 Rev A01

2.4.5 Storm Water Retention Pond
The storm water retention pond is located to the south west of the site, within the lowest gradient area
of the site. This consists of two separated lined holding lagoons with a combined storage capacity of
3
10,000m . The pond is used to avoid the possible discharge of contaminated surface water arising
from a spill and/or fire incident or other accident involving contaminated water flowing into the storm
water drain system. All water flowing into this system is continuously monitored with a system in place
for retaining any contaminated water in the event of exceedance of storm sewer water quality limits
which can be pumped directly back to the WWTP for treatment prior to discharge.
2.4.6 Waste Water Treatment Plant (WWTP)
This area is located to the east of the site and is used to treat all process water and sewer water prior
to discharge from the site. Table 2.7 provides an inventory of all tanks in the WWTP.
2.4.7 Liquid Vapour Incinerator (LVI)
The LVI is located to the east of the site boundary in the environmental controls area of the site. This
system is used for the destruction of non-recoverable solvents, process wastes and process vapours
in addition to the recovery of heat for steam generation and energy conservation. As a back up to the
LVI, there is a Redundant Vapour Treatment Module (RVTM) located adjacent to the LVI. The RVTM
operates for a total of approximately two weeks per year during periods when the LVI is undergoing
maintenance. Both sources discharge through the same emission point and are subject to the same
emission limit values (Emission Point Reference No. 4, Schedule B). In 2011, Novartis Ringaskiddy
Limited installed a Wet Electrostatic Precipitator (WESP) at the LVI to treat the off gases from the
incineration process.
2.4.8 Solid Waste Incinerator (SWI)
The SWI is located to the east of the site boundary in the environmental controls area of the site.
This incinerator is a much smaller system than that of the liquid vapour. It is used for the destruction
of contaminated packaging and other combustible wastes. The system consists of a multiple chamber
fired with natural gas and a flue gas cleaning system.
2.4.9 Utility Building and Service Yard
This area of the facility is located within the mid west area of the site and houses the heating systems
consisting of two gas fired boilers with oil as backup, air compressors, water softening plant and
chillers. External to the building, the services yard contains a cooling tower, a gasoil fired generator
and a bunded fuel oil and glycol storage area.
Adjacent to the Utility Building is an external yard for the storage of segregated non-hazardous waste
from ongoing projects around the facility. The storage area was constructed of gravel aggregate but
this has been replaced with a hard standing tarmac base in 2012 in line with an EPA request in 2011.
MDE0970Rp0013 16 Rev A01

2.4.10 Technical Services Building
This building is used for the maintenance and repair of plant and equipment, a workshop and also
houses the in-house fire brigade.
2.4.11 Waste Management
The non-hazardous waste management area is located adjacent to the utility building. An inventory of
the waste volumes for 2013 are presented in Tables 2.8 and 2.9. A detailed list of the wastes
produced along with the relevant EWC codes are presented in Appendix B.
2.5 SITE INVENTORY
The main facility buildings, plant raw materials and wastes are itemised in Tables 2.3 to 2.9 in the
following pages.
MDE0970Rp0013 17 Rev A01

Table 2.3: List of Site Buildings and Plant on Novartis Ringaskiddy Limited facility
Building/Plant Area Function

PB1 Synthesis of bulk chemicals (Multi-synthesis)
PB1A Annex building to PB1 for sensitive reactions
Synthesis and Purification of bulk chemicals (Predominately Diovan and
PB2
Cyclosporine
Main Warehouse Storage of raw materials (solids/powders/liquids) Category 5, 7, 8 10 Warehouses
Storage of substances liable to undergo auto-reaction or spontaneously flammable
Category 2 Warehouse
substances
Category 3 & 4 Storage of substances igniting or producing flammable gases when in contact with
Warehouse water
Category 6 Warehouse Storage of Flammable liquids with a flashpoint of less than 56C
Category 9 Warehouse Storage of compressed and liquefied gases
Tank Farm Storage of bulk liquids and solvents as raw materials
Solvent recovery area Recovery of solvents through distillation of solvents used in production
Solid Waste Incinerator
Incineration of authorised packaging and other combustible wastes
(SWI)
Liquid Vapour Incinerator Incineration of non-recoverable solvents, process wastes and process vapours and
(LVI) recovery of heat from steam generation and energy conservation
Redundant Vapour
Back up abatement option for the LVI during shut downs and scheduled
Treatment Module
maintenance
(RVTM)
Wet Electrostatic
Treatment of off gases from the LVI for particulates/metals
Precipitator (WESP)
Waste Water Treatment
Treatment of all process and effluent water prior to discharge from the site
Plant (WWTP)
Utility Building Housing of gas and oil heating air compressors, water softening plant and chillers
Storage area Housing of Fuel oil and Glycol storage tanks in addition to cooling tower and chillers
Storm water retention Holding pond for any contaminated fire water or storm water discharge prior to
pond discharge
Administration Building Main office and admin area, including canteen, staff toilets etc
NIPBI building Supply chain management and QC/Reference Standards activities
Fire water tank Storage of water for fire emergency use
Portable water tank Storage of water
Bunded areas Containment of spillages
Catchment Basins Containment of spillages
Spill Basins 1 and 2 Containment of spillages
SSF As with all process buildings
Transport of liquid raw materials and liquid waste materials to and from production
Overhead solvent lines
buildings
MDE0970Rp0013 18 Rev A01

Table 2.4: Tank Farm Inventory
Number of Catchment Total Tank

Spill Basin Catchment No. 3 3 Solvents
Tanks Volume (m ) Volume (m )
Butyl Acetate
Methyl Ethyl Ketone
1 8 87.168 272.24 n-Methylpiperizine
3-methyl-1-butanol
Solvent Waste
Ethyl Acetate
2 11 106.764 334.46 Heptane
Solvent Waste
Aqueous Waste
Toluene
Butanol
3 8 94.996 272.24
Cyclohexane
Ethanol
1
Tetrohydrofuran
Acetonitrile
Acetic Acid
t-amyl-alcohol
4 10 116.045 340.03
Isopropyl alcohol
Ethanol
Dimethyl formamide
Isopropyl acetate
Caustic
5 3 66.140 102.09
Solvent Waste
Liquid/Vapour
6 - 42.45 Solvent Waste
Recovery
Solvent
21 - 77.71 Solvent Waste
Recovery
Isopropyl acetate
Acetone
Ethyl Acetate
6 10 170.013 621.63
Methanol
Solvent Waste
7 8 109.829 372.78 Isopropyl acetate
Ethyl acetate
Ethyl acetate
Heptane/Isopropyl
2
8 10 141.122 620.20 alcohol
Heptane/Acetone
Acetone
Cyclohexane/Ethyl
acetate
9 12 88.176 466.65 Cyclohexane
Ethyl acetate
Ethyl acetate/Water
Isopropyl acetate
10 9 118.193 373.32 Tetrohydrofuran
Water/Acetone
MDE0970Rp0013 19 Rev A01

Table 2.5: List of solvent usage in 2013
Solvent Raw Materials Names 2013 Quantity (kgs)
n-Heptane (HPTF) 50,920
3-Methyl-1-Butanol 650,160
Acetone (ACT) 842,560
Acetonitrile (ACNL) 99,780
Cyclohexane (CHXA) 1,159,119
Ethanol denatured with Isopropanol (ALI) 42,180
Ethanol denatured with Toluene (ALABD) 88,225
Ethyl Acetate (ESTP) 2,219,800
Glacial Acetic Acid (EEMA) 17,860
Isopropanol (IPK) 176,074
Isoproply Acetate (IPA) 567,020
Methanol (MY) 1,393,453
Methyl Ethyl Ketone (MEK) 218,100
n,n-Dimethylformamide (DIF) 246,750
n-Butanol (BLN) 617,460
n-Butlyacetate (BLNAK) 693,960
n-Methylpiperazine (MPI) 79,880
t-Amyl Alcohol (TAA) 13,900
tert-Butyl Methly Ether (TBME) 382,860
Tetrahyrdofuran (THFU) 581,700
Toluene (TO) 167,620
Table 2.6: Inventory of warehouses at the Novartis Ringaskiddy Limited facility
Warehouse Materials
Storage of raw materials (solids/powders/liquids) Category 5, 7, 8 10
Main Warehouse
Warehouses
Storage of substances liable to undergo auto-reaction or spontaneously
Category 2 Warehouse
flammable substances
Storage of substances igniting or producing flammable gases when in contact
Category 3 and 4 Warehouse
with water
Category 6 Warehouse Storage of Flammable liquids with a flashpoint of less than 56C
Category 9 Warehouse Storage of compressed and liquefied gases
MDE0970Rp0013 20 Rev A01

Table 2.7: Modules contained in WWTP system
Original
Module Source of Water Function Controls
Construction
Sealed/lined
Stainless steel tank,
gases vented to
Liquid Vapour
Process Water Incinerator (LVI) Production and utility
Pumping Station
Lift station Since major works buildings, floor drains
in 2008, the entire
structure is now
visible and free
standing
Sanitary Lift Underground,
Sanitary effluent Pumping Station
Station concrete tank
Underground, lined Tank farm/solvent
Spill Basin concrete tank open to recovery/liquid vapour Pumping Station
the surface incinerator bunds
Overground, lined
concrete tank , fitted All monitoring
Primary
Equalisation Tank with monitoring Process Lift Station and control
Treatment
system, covered and functions are
vented to LVI controlled by
Above ground, free Distributed
Neutralization standing tank lined Primary Control Systems
Equalisation Tank by gravity
Basin stainless steel, vented Treatment (DCS)
to LVI
Overground, lined
Pumped from Neutralization Secondary
Aeration Basin concrete tank covered
Basin Treatment
and vented to LVI
Overground, Fed by gravity from Aeration Secondary
Clarifier
permaglass tank basin Treatment
Overground, lined
concrete tank,
Digester Discharged from Clarifier Sludge Handling
covered and vented to
LVI
Mechanical Press
Sludge
Belt Filter Press Filter, bunded in Pumped from Digester
Dewatering
building
Pumped from Digester
Steel drum and motor, Sludge
Centrifuge (used as alternative to Belt
bunded in building Dewatering
filter press)
MDE0970Rp0013 21 Rev A01

Table 2.8: Summary of 2013 Total Waste Arisings on Site (tonnes)
Waste 2009 2010 2011 2012 2013
Total quantity of waste produced in

18,793 18,237 16,244 20,050 19,162
calendar year (tonnes)
Total quantity of waste disposed of on-site 868 675 809 749 684
Total quantity of waste disposed of off-site 1,289 1,214 545 1,447 1,806
Total quantity of waste recovered on-site 8,076 8,782 5,857 8,492 6,723
Total quantity of waste recovered off-site 8,560 7,566 9,033 9,362 9,949
Table 2.9: Breakdown of 2013 Hazardous and Non-Hazardous Waste Produced on Site (tonnes)
2009 2010 2011 2012 2013
Quantity of non-hazardous waste

1,919 1,741 1,472 1,820 2,201
produced in calendar year (tonne)
Quantity of non-hazardous waste disposed

1 2 3 2 2
of on-site
Quantity of non-hazardous waste disposed

182 112 75 251 123
of off-site

0 0 0 0 0
recovered on-site

1,736 1,627 1,394 1,567 2,076
recovered off-site
2009 2010 2011 2012 2013
Quantity of hazardous waste produced

16,874 16,496 14,772 18,230 16,961
in calendar year (Tonnes)
Quantity of hazardous waste disposed of

867 673 805 747 682
on-site
Quantity of hazardous waste disposed of

1,107 1,102 471 1,196 1,683
off-site
Quantity of hazardous waste recovered

8,076 8,782 5,857 8,492 6,723
on-site
Quantity of hazardous waste recovered

6,824 5,939 7,639 7,795 7,873
off-site
MDE0970Rp0013 22 Rev A01

3 CLOSURE TASKS AND PROGRAMME
3.1 CLOSURE CONSIDERATIONS
The requirements of Condition 10.1 of the IEL requires Novartis Ringaskiddy Limited to render safe or
remove for disposal/recovery, any soil, subsoils, buildings, plant or equipment, or any waste, materials
or substances or other matter contained therein or thereon, that may result in environmental pollution.
In order to develop a fully costed Closure Plan for the Novartis Ringaskiddy Limited facility, a number
of assumptions have been made:
It has been assumed that the closure of the facility will be an unforeseen event with no
planning incorporated into the day to day operation of the site. This is a worst case scenario
as typically for such a facility, the closure would be a well-planned event and production
schedules and raw materials purchasing and storage will be planned to reflect this. For this
closure scenario, it is assumed that the warehouses, tank farm and waste storage areas are at
capacity at the time of closure.
The entire industrial facility will be fully decontaminated (i.e. cleaned) and decommissioned
(i.e. rendered safe and removed from the site where stated). All solvents, wastes, materials,
etc. on the site will be removed and treated as waste.
It has been assumed that the costs of decontamination and decommissioning will be based on
contractors carrying out such works, i.e. these are not standard Novartis Ringaskiddy Limited
operational costs.
It is proposed that the LVI, SWI and WWTP will remain operational through the closure
process. The cost for the operation of this plant has been incorporated into the plan to off set
the costs for disposal of material off-site. The LVI and SWI will operate with in the capacity
constraints and waste types listed in Schedule A of the IEL.
It is not proposed to demolish any of the buildings or infrastructure (e.g. WWTP) on the site. It
has been assumed that the site and buildings may be sold by Novartis Ringaskiddy Limited to
any interested party but the fee value of any such acquisition has not been factored into the
costing presented in Section 6 of this plan. In other words, any credit gained from the sale of
the site and/or plant has not been used to offset the debit of the closure costs.
This Closure Plan will be subject to annual reviews, particularly focusing on the cost and
suitable financial provisions and take into account any changes in the activities carried out at
the facility.
Based on the information contained in the previous sections, which has taken into account the
processes, environmental risks posed by the facility and its compliance history, there is no
requirement for restoration or aftercare management at the Novartis Ringaskiddy Limited site. This is
based on the fact that the site has no appreciable sources of ground or soil contamination, which will
require aftercare management, and the environmental controls in place are considered sufficient to
maintain a non-contaminated site status until closure. As such, this plan includes for the closure of the
facility to meet the requirements of Condition 10.1 of the IEL. The closure plan will take account of the
decontamination and decommission of all plant buildings and equipment (i.e. to render safe the site).
MDE0970Rp0013 23 Rev A01

Upon closure, it is recommended to conduct a validation of clean closure by way of outline soil/ground
water assessment in key potential source areas to verify that significant soil/groundwater contaminants
do not present additional long-term liability that requires restoration and aftercare management.
3.2 PROGRAMME TO ACHIEVE CLOSURE
The production processes at Novartis Ringaskiddy Limited are carried out under well-defined and strict
controls. These controls include Standard Operating Procedures (SOPs), Good Manufacturing
Practice (GMP) and legislative and regulatory controls.
In the event that the entire facility is closed, all areas of the facility will be decommissioned and
decontaminated. Figure 3.1 summarises the likely methodology employed in fully decommissioning
and decontaminating the entire facility.
It is estimated that the closure of the production facility and associated infrastructure would take a 12
month timeframe to achieve all steps in Figure 3.1.
MDE0970Rp0013 24 Rev A01

Figure 3.1: Flow Diagram of Likely Order of Full Site Closure
Decommissioning of Plant Buildings

Step 1
Emptying of Warehouses and

Shipments of raw materials to Decommissioning of buildings Step 2
suppliers/incinerated
Cleaning procedure as per Emptying of Tank Farm

CIP/COP Step 3
Shutdown and Decommission of Liquid

Vapour Incinerator Step 4
Shutdown & Decommission of Cooling

Sludge removed for land filling Towers Step 5
Removal of Glycol by Drainage of Glycol Tanks Step 6

contractor
Removal and Collection by Decommission of Chillers

contractor Step 7
Waste Emptying of Fuel Oil Tanks

Step 8
Shutdown and Decommission of Boilers

Step 9
Clear out of Contractors Compound

Step 10
Shut down and Decommission of Solid

Waste Incinerator Step 11
Contaminated waters Decommission of WWTP

discharged to SB1 Step 12
and tankered off-site
MDE0970Rp0013 25 Rev A01

3.3 CLOSURE PLAN
Step 1: Decommissioning and Decontamination of Production Buildings
There are three production buildings at the Novartis Ringaskiddy Limited facility PB1, PB1A and
PB2. In addition, the small scale facility will be closed following the procedures outlined below.
Due to the operations conducted on the Novartis Ringaskiddy Limited site there is a large emphasis
placed on ensuring that all plant equipment is fully decontaminated during switch over of drug batches,
which use the same equipment. This is especially true for Production Buildings 1 and 1A, which are
used for the multi-synthesis of bulk chemicals.
Decontamination of production equipment buildings is included as part of a site wide Standard

Operating Procedure (SOP). The Cleaning Validation Masterplan Cleaning Procedure document
outlines the principles and procedures that are to be followed when carrying out all plant cleaning
validation services. For dedicated equipment, validation is limited to the removal of detergents,
disinfectants and prevention of microbiological contamination. This is part of regular practice in the
plant and therefore would not incur significant costs, resources or time to undertake. Figure 3.2
illustrates the likely sequence and methodology employed in fully decommissioning and
decontaminating a production building. The steps are described in further detail below:
Step 1.1: Emptying & decontamination of all vessels
Assume final product in the production building has been processed. Solvent waste must then be
removed from vessels using SOP.
The steps contained in the Cleaning Validation Master Plan will be followed in order to ensure that all
vessels are fully decontaminated. This will involve manual cleaning performed manually by an
operator using specified cleaning material which might include high pressure jetting but is equipment
specific and Clean out of place (COP) procedures involving disassembling process equipment and
cleaning using manual methods or re-circulating washers.
Cleaning sequences involve:
Preliminary Cleaning: Use of designated solvents with brushing or high powered jets.
Main Cleaning: Cleaning of equipment with solvent. A sample last rinse/final cleaning is
analysed.
Validation Protocol: Similar to procedures used for new batch products, an authorised
validation protocol must be followed and approved by head of production and head of quality
assurance.
Step 1.2: Removal of excess raw materials/IBCs /FIBCs in production building
This stage will involve the safe removal of any additional raw materials back to storage warehouses as
per category storage. Novartis Ringaskiddy Limited operates a system where raw materials are
brought into production areas on an as-need basis only in order to avoid stockpiling supplies on the
production floor. In the event of closure raw materials can be treated on site in the liquid vapour
incinerator or the solid waste incinerator as appropriate.
MDE0970Rp0013 26 Rev A01

Step 1.3: Isolate all manifolds and drain back to bulk storage & purge manifolds
To be undertaken as per line cleaning and validation procedures. No specific residual associated with
this step.
Step 1.4: Cleaning of overhead lines/floors & removal of air filters
All high level contaminants are kept within a contained system within production buildings, which
should ensure that overhead lines are not contaminated. Procedural steps involved in this stage will
be as per the sites cleaning validation master plan. All overhead pipes will involve preliminary and
main cleaning, involving analytical validation of decontaminated lines.
Removal of HVAC filters will be undertaken by dedicated members of staff involved in maintenance of
HVAC systems. All filters will be bagged, labelled and incinerated in the SWI. Ducts upstream and
down stream of filters will be cleaned down and dismantled.
Step 1.5: Decommissioning of lines between Liquid Vapour Incinerator (LVI) and Production
Building
Once all solvents are fully removed from production building, the LVI lines can be isolated and
decommissioned. A full purge and cleaning of the lines will be required. All vapour hoods will be
decontaminated and dismantled. All liquid flame arrestors will be handled with reasonable care to
prevent the potential for fire hazard in the production areas.
Step 1.6: Removal of plant items
All plant items when certified as decontaminated and non-hazardous can be safely removed from the
building. Vessels and other high-grade metal/stainless steel items can be sold. Other plant items will
be disposed off site by a licensed/permitted waste management operator.
Step 1.7: Walls, floors and process drains flushed
This final stage of building decontamination will involve a complete power wash of walls, ceilings and
process drains by contract cleaners. All contaminated waters will be drained to Spill Basin 1 and
treated in the WWTP or tankered off site for treatment.
Plant Status at Completion of Closure Scenario 1
Plant items decontaminated and removed safely from production building
All solvent lines, LVI lines and glycol lines isolated and decommissioned from Production
Building
Production Building fully decontaminated and decommissioned
MDE0970Rp0013 27 Rev A01

Figure 3.2: Flow Diagram of Decommissioning of Production Buildings (Step 1)
Emptying of all vessels

Step 1.1
Clear out of all vessels as per CIP standard All waste

CIP and GMP Spec procedures solvents/cleaning
testing solvents incinerated
All containment suites and Removal of all excess raw materials/IBCs Raw materials sent to
containment units to be in production building storage warehouse and
dismantled and incinerated
Step 1.2
incinerated
Isolate all process manifolds and drain back

to bulk storage and purge manifolds Step 1.3
Cleaning of overhead pipes/lines and floors
Step 1.4
Removal of HVAC Filters

Filters bagged and
incinerated
Cleaning of duct work at Inlet and Outlet

areas
Decommissioning of lines between LVI and Step 1.5

PB.
Recovery of plant items Removal of Plant Items Step 1.6

where possible
depending on resale
value. Disposal of other
plant items where no
monetary value is
associated
Floor Cleaning/Process Drains Power Contaminated waters

Step 1.7 discharged to SB1
External Contractor washed, decontaminated
and treated in WWTP
or tankered off-site
Testing and Certification of Building

Decontamination
MDE0970Rp0013 28 Rev A01

Step 2: Emptying of Warehouses & Decommissioning of Warehouse Buildings
Each of the relevant warehouses will be emptied on a phased basis depending on the closure of the
production buildings. All raw materials will be disposed of through the sites solid waste incinerator and
liquid vapour incinerator where safe to do so. For unsuitable materials, these will be stored in
sufficient bulk containers for collection by licensed contractors for recovery/disposal off-site. Emptied
warehouse buildings will be decontaminated fully. Contractor cleaners will fully decontaminate walls,
ceilings and floor drains.
All non-hazardous waste will be segregated and sorted for recycling/reuse or disposal by licensed
contractors.
All washing water generated during cleaning process will flow into the process drains in the relevant
warehouse buildings. These flow directly into the lift station of the WWTP. In the event where washed
waters are highly concentrated with pollutants this liquid can be diverted to Spill Basin 1 for
temporary storage and fed through the WWTP to suit the treatment load of the system or pumped out
for off-site treatment.
Step 3: Emptying, Decontamination and Decommissioning of Tank Farm and Solvent Recovery
Unit
The planned shut down of the plant and tank farm will make provisions to ensure adequate solvents
used for decontamination and cleaning in all process areas in addition to ensuring excessive solvents
are not in storage at the time of shut down. All tanks will be emptied and purged into the LVI
(approximately 50% at a time). The licensed capacity of the LVI is 1,100 kg per hour (Schedule A.2 of
the IEL) which equates to approximately 800 tonnes per month. As a worst case assumption that all
3
tanks were at full capacity (3,200m or 2,400 tonnes approximately) at closure, the time frame for
emptying all tank farm contents is three months as a maximum.
The annual cost to operate the LVI is estimated at 1,116,000 which includes personnel costs,
consumables, resource consumption, etc. This equates to a monthly cost of 93,000.
All lines will be isolated from tanks and tanks fully cleaned and decontaminated using SOP for
cleaning and validation. Decontaminated tanks will be dismantled. High-grade steel tanks can be
sold.
All bunded areas and solvent/process drains will be flushed and cleaned. All liquid waste generated
during cleaning processes will be directed to the process drains in the tank farm/solvent recovery area.
These flow directly into the lift station of the WWTP. In the event where washed waters are highly
concentrated with pollutants this liquid can be diverted to the spill basin for temporary storage and
fed through the WWTP to suit the treatment load of the system or pumped out for off-site treatment.
Step 4: Shutdown and Decommission of Liquid Vapour Incinerator
After all tanks farm and solvent recovery areas are emptied, the LVI can be discontinued. Vapour line
from WWTP can be isolated at this point and a peat absorption filter used in its place. The
decommissioning of the LVI will involve purging and isolation of all feeder lines.
As a back up to the LVI, there is a Redundant Vapour Treatment Module (RVTM) located adjacent to
the LVI. The RVTM operates for a total of approximately two weeks per year during periods when the
LVI is undergoing maintenance. In 2012, Novartis Ringaskiddy Limited installed a Wet Electrostatic
Precipitator (WESP) at the LVI to treat the off gases from the incineration process. The Redundant
MDE0970Rp0013 29 Rev A01

Vapour Treatment Module (RVTM) and Wet Electrostatic Precipitator (WESP) will also be
decommissioned as part of this step.
Step 5: Decommission of Cooling Towers
Cooling towers will be shutdown and decommissioned. All non-contact cooling water will be treated as
hazardous waste and providing it meets licence requirements, will be incinerated on-site.
Step 6: Drainage of Glycol Tanks
All residual glycol to be removed from tanks and stored in adequate bulk containers for collection by
contractor for recovery. Tank to be fully decontaminated using COP system.
Step 7: Decommission of Chiller Units
Chiller units are to be shut down and fully decommissioned. Currently, no new R22 gas is used on
site and use of the existing R22 is being phased out. Ammonia is now used as a refrigerant and will
ultimately fully replace the use of R22 over the next two to three years at the facility. Any residual
refrigerant to be put into bullet containers and collected for re-processing by licensed contractor.
Step 8: Emptying of Fuel Oil Tanks
All fuel oil tanks including fuel oil in firewater pump house to be emptied and collected by licensed
contractor.
Step 9: Shutdown and Decommission of Boilers
This step will involve the decommissioning of the boiler house and associated system, return of boiler
treatment chemicals to supplier and collection of lubricating oils by contractor.
Step 10: Contractors Compound
The Contractors compound on the west of the facility will be used throughout the Closure. Activities at
the Compound will be overseen by Novartis Ringaskiddy Limited to ensure compliance with legislative
and EMS requirements. Once the main contractors have finished, the compound site will be cleared
and all waste remove off site by licensed contractors.
Closure of this area of the site will involve dismantling of cabins, removal and safe disposal of wastes
hazardous chemicals, paints to be collected by licensed contractor. All non hazardous waste will be
segregated for recycling/recovery or disposal and will be collected by appropriate licensed contractors.
Following the 2004 EMAS audit, remediation was undertaken in the compound to ensure that no
residual soil or groundwater contamination existed. The results indicate no contamination. All waste
arising in this area is tracked through the Novartis Ringaskiddy Limited waste tracking system.
Step 11: Decommissioning of the Solid Waste Incinerator
The solid waste incinerator may be decommissioned once all waste streams listed in Table A.2 of the
IEL have been disposed of safely. The licensed capacity of the SWI is 200 kg per hour (Schedule A.2
MDE0970Rp0013 30 Rev A01

of the IEL) which equates to approximately 146 tonnes per month. On average approximately 60
tonnes of waste is disposed of annually through the SWI and conservatively assuming that ten times
this annual volume of material would be generated upon closure (600 tonnes), the operation of the
SWI would be required for approximately 4 months.
The annual cost to operate the SWI is estimated at 1,149,000 which includes personnel costs,
consumables, resource consumption, etc. This equates to a monthly cost of 95,750.
Decommissioning of the SWI will involve the shut down and decommission of this item of plant. A full
clean and decontamination will be undertaken as per the sites CIP and COP procedures.
Wastes generated from the incinerator will be disposed of as per normal practice. Bottom ash and
slag will be removed off site to an external waste handler in Germany under the TFS Regulations for
further treatment in a licensed hazardous waste treatment facility. Spent lime and activated carbon
will be removed, shipped to an external waste handler in Belgium under the TFS Regulations for reuse
in a licensed hazardous waste treatment facility.
Step 12: Decommission Waste Water Treatment Plant (WWTP)
The WWTP will be one of the last items of plant to be fully decommissioned as all wash water from the
decontamination of the production areas, warehouses, tank farm, etc. will be routed to the WWTP for
treatment. The decommissioning of the WWTP will involve a phased closing of various tanks in order
to allow for the staged treatment of all waste water from the site.
The WWTP capacity can be halved to allow for partial shut down and cleaning of tanks in the system.
Table 3.1 summarises potential partial shut down of the WWTP to allow for cleaning of the system.
Table 3.1: Proposed use of WWTP Units
WWTP Unit Secondary Function

Equalisation tank Moved to Aeration Tank 1
Aeration Tank 2 Digester
Aeration Tank 3 Aeration Tank 3
Clarifier 1 Clarifier 1
Clarifier 2 Emptied
The WWTP can continue treating water prior to discharge while the remaining tanks are cleared and
cleaned. After full decommissioning of non-operational tanks, the final system can be drained and
cleared. Sludge to be removed for off-site treatment (approximately 745 tonnes as an annual total in
2013) and it has been assumed that one years sludge would be removed from the site.
Upon final drainage of the WWTP tanks, all tanks located below ground level (lift station, neutralisation
tank and spill basin) to be fully emptied. Following full emptying of the WWTP, this system will need to
be fully decommissioned.
Residual Waste Disposal/Recovery
The operation of the LVI, SWI and WWTP on the Novartis Ringaskiddy Limited facility enables much
of the waste generated as a result of the closure to be disposed of on-site. All residual waste will be
stored and sent off site for recovery/disposal by a suitably permitted operator. The waste volumes
MDE0970Rp0013 31 Rev A01

anticipated at closure for disposal/recovery off-site are based on the 2013 annual volumes as
presented in Table 2.9.
MDE0970Rp0013 32 Rev A01

4 CRITERIA FOR SUCCESSFUL CLOSURE
In order to achieve clean closure, the following benchmark set of criteria will need to be met as per
EPA 2014 document;
Full decontamination and decommissioning of all production buildings, including ancillaries

such as the incinerators and tank farms with shipping records for dispatch (if being exported),
All end products dispatched off site,
All excess raw materials are removed from site,
All warehouse and storage buildings have been fully emptied and stored material transported
or disposed of,
All waste has been disposed or recovered in a manner which complies with regulatory
requirements,
All site services have been fully decontaminated and decommissioned and verified using
analytical testing and certified,
All relevant records relating to waste and materials movement and transfer or disposal will be
managed and retained throughout the closure process,
Independent verification that no soil or groundwater contamination exists on the site upon
closure through additional site investigation, and
Independent verification and certification of clean closure status.
MDE0970Rp0013 33 Rev A01

5 CLOSURE PLAN VALIDATION
Novartis Ringaskiddy Limited management will notify the OEE of all plans to cease operations with full
closure of the site. An agreed time frame and methodology will be submitted to the EPA for
agreement prior to any cessation.
Other statutory bodies including the local authority will be notified of plans to cease operation and
proposed closure time frame.
A test programme will be implemented on sequential planned order of closure in order of:
1. Decontamination verification;
2. Final investigation/integrity test of underground structures; and
3. Soil and groundwater validation investigation.
Upon completion of implementation of the Closure Plan, Novartis Ringaskiddy Limited will conduct a
validation audit to demonstrate to the EPA that the closure plan has been implemented. The
qualification and experience of the auditor will be provided to the Agency prior to the validation
commencing and a validation report will be submitted to the Agency upon completion.
MDE0970Rp0013 34 Rev A01

6 CLOSURE PLAN COSTING
Table 6.1 presents an estimation of the costs associated with achieving the closure of the facility to
comply with Condition 10.1 of the IEL. The costs presented have been estimated based on the
following assumptions:
Assuming the warehouse and tank farms are at typical capacities at the time of closure, i.e.
they are not reduced as part of a planned closure.
Assuming the operation of the LVI for a 3 month period to fully dispose of all suitable solvent
waste on site in line with the IEL.
Assuming the operation of the SWI for a 4 month period to fully dispose of all suitable solid
waste on site in line with the IEL.
Assuming the operation of the WWTP for 6-12 months to treat all wash waters from the
decontamination and decommissioning processes.
Assuming the waste volumes are four times the typical annual volumes as a worst case and
the waste disposal/recovery options are as per the existing arrangements.
The costing assumes that the closure of the facility is a totally unplanned event and the costs for
carrying out cleaning, decontamination and decommissioning works are based on a third party
carrying out the works and not Novartis Ringaskiddy Limited personnel.
MDE0970Rp0013 35 Rev A01

Table 6.1: Costing of closure of the Novartis Ringaskiddy Limited facility
Quantity Measurement Unit Rate Cost

Task Description
(No.) Unit () ()
Production Building PB1 - Cleaning contractor costs (1 supervisor, 4 operatives) 5 day 2,100 10,500
Production Building PB1A - Cleaning contractor costs (1 supervisor, 4 operatives) 5 day 2,100 10,500
Production Building PB2 - Cleaning contractor costs (1 supervisor, 4 operatives) 5 day 2,100 10,500
Small Scale Facility (SSF) - Cleaning contractor costs (1 supervisor, 4 operatives) 3 day 2,100 6,300
Main Warehouse - Cleaning contractor costs (1 supervisor, 4 operatives) 5 day 2,100 10,500
Category 2 Warehouse - Cleaning contractor costs (1 supervisor, 4 operatives) 1 day 2,100 2,100
Category 3&4 Warehouse - Cleaning contractor costs (1 supervisor, 4 operatives) 2 day 2,100 4,200
Plant and equipment Waste Management Area - Cleaning contractor costs (1 supervisor, 4 operatives) 3 day 2,100 6,300
decontamination Laboratory - Cleaning contractor costs (1 supervisor, 4 operatives) 2 day 2,100 4,200
Administration Building, Control Rooms, NIPBI Building, Technical Services 5 day 2,100 10,500
Utilities Building (personnel costs) 3 day 2,100 6,300
Solvent Tanks in the Tank Farm (personnel costs) 116 unit 1,200 139,200
Solvent Recovery Area (personnel costs) 5 day 2,100 10,500
Glycol Storage Tanks (personnel costs) 2 day 2,100 4,200
Fuel Storage Tanks (personnel costs) 1 day 2,100 2,100
Purging of overhead solvent lines (personnel costs) 5 day 2,100 10,500
Process drain jetting (personnel costs) 5 day 2,100 10,500
Decontamination of the WWTP (personnel costs) 20 day 2,100 42,000
Plant and equipment Production Building PB1 - contractor costs (1 supervisor, 3 operatives) 10 day 2,000 20,000
decommissioning, i.e. Production Building PB1A - contractor costs (1 supervisor, 3 operatives) 10 day 2,000 20,000
removal from service Production Building PB2 - contractor costs (1 supervisor, 3 operatives) 10 day 2,000 20,000
for plant and
Small Scale Facility (SSF) - contractor costs (1 supervisor, 3 operatives) 3 day 2,000 6,000
equipment.
Laboratory - contractor costs (1 supervisor, 3 operatives) 3 day 2,000 6,000
Solvent Tanks in the Tank Farm 116 unit 750 87,000
Solvent Recovery Area (Distillation Units) 15 unit 800 12,000
Glycol Storage Tanks 1 unit 4,000 4,000
Fuel Storage Tanks 2 unit 1,500 3,000
Nitrogen Storage 1 unit 3,000 3,000
Boilers 2 unit 4,000 8,000
Chillers and Cooling Towers 1 unit 10,000 10,000
Liquid Vapour Incinerator, RVTM and WESP 1 unit 25,000 25,000
Solid Waste Incinerator 1 unit 25,000 25,000
MDE0970Rp0013 36 Rev A01

Quantity Measurement Unit Rate Cost

Task Description
(No.) Unit () ()
Contractors Compound and Project Warehouse 3 day 2,000 6,000
Waste Solvent Disposal through LVI 3 month 93,000 279,000
Solid Waste Disposal through the SWI 4 months 95,750 383,000
Waste Management Area non hazardous waste (gate fee including levy) 123 tonne 120 14,760
Waste Management Area non hazardous waste (transport) 123 tonne 15 1,845
Waste Waste Management Area hazardous waste (gate fee) 1,683 tonne 150 252,450
Disposal/Recovery Waste Management Area hazardous waste (transport) 1,683 tonne 75 126,225
WWTP Sludge (gate fee) 745 tonne 200 149,000
WWTP Sludge (transport) 745 tonne 70 52,150
Residual fuels from decontamination stage (transport and disposal) 10 tonne 75 750
Interceptor sludge (transport and disposal) 5 tonne 70 350
Site Investigation (Consultant Costs) 20 days 650 13,000
Groundwater Monitoring (5 wells biannually as per C.6 ) 10 sample 200 2,000
Environmental Surface Water Monitoring SW1 (as per C.2.3 for 1 year) 1 annual 5000 5,000
monitoring Emissions to Sewer Monitoring (W1 and EP100 as per C.3.2 for 1 year) 1 annual 10000 10,000
Noise monitoring (annually) 1 annual 3000 3,000
Waste monitoring (assuming 20 samples for Classification Tool) 20 sample 300 6,000
Site Security Security personnel (1 year for 24 hour security presence on site) 12 month 25000 300,000
Validation audit Validation Report (Consultant costs) 10 day 650 6,500
Management (Site Manager, part time 2 days per week) 104 days 500 52,000
Management Costs
Other administration overheads 12 month 2000 24,000
Total () 2,245,330
Contingency (%) 20%
Total including contingency() 2,694,396
MDE0970Rp0013 37 Rev A01

7 CLOSURE PLAN UPDATE AND REVIEW
In accordance with the IEL the plan shall be reviewed annually and proposed amendments thereto
notified to the Agency for agreement as part of the AER. The CRAMP is reviewed annually by RPS in
conjunction with Novartis Ringaskiddy Limited and reported through the AER. The review for 2014 is
the most recent and includes a number of amendments and revisions of cost estimates based on
experience gained and market conditions. This Plan will be reviewed annually and amended to reflect
any significant alterations on site.
MDE0970Rp0013 38 Rev A01

8 COST SUMMARY
Summary costs for closure, restoration and aftercare management as calculated in 2014 are
2,694,396 (including 20% contingency).
In order to future proof the costs against inflation, the predicted costs (including contingency) have
been projected including an annual inflation rate of 2% (for projects in the medium to long term). The
inflation rate of 2% is derived from the government Project Discount & Inflation Rates as published on
the Department of Public Expenditure and Reform http://per.gov.ie/project-discount-inflation-rates/. No
discounting has been applied to the costs.
Table 8.1 presents a predicted cost for the closure of the Novartis Ringaskiddy Limited facility
accounting for inflation and assuming that the facility will cease operation in 2015 and closure will be
completed in 2016.
The results of the projections indicate that for the full closure of the facility the financial provision to
cover the future liability including contingency and accounting for inflation is 2,599,366. This figure is
exclusive of VAT.
Table 8.1: Future Cost Estimates for Closure of the Novartis Ringaskiddy Limited facility
Year Scenario Closure Cost ()

2013 CRAMP Prepared 2,694,396
2014 Cessation of Activity 2,748,284
2015 Closure of Production Area and drawdown of Costs 2,803,249
MDE0970Rp0013 39 Rev A01

9 CONCLUSION
Condition 10 of the Novartis Ringaskiddy Limited IEL (P0006-03) requires the company to prepare a
Closure, Restoration and Aftercare Management Plan for the closure of the facility. RPS has reviewed
the CRAMP in 2014 to update the costs and outline any new developments at the facility.
2014 has been used as the basis for the methodology in preparing this report.
The calculated Financial Provision for the closure of the facility is 2,803,249 (exclusive of VAT). This
figure is based on a detailed analysis of the closure tasks and rates are based on existing suppliers
and industry norms. Where there is uncertainty in the task or program a conservative estimate has
been provided and a high level of contingency (20%) has been has been applied to the costing to
ensure a robust financial provision. Finally, all costs have been projected based on a 2% inflation rate
but no discounting has been applied and VAT has not been added.
Novartis Ringaskiddy Limited is committed to ensuring the highest level of environmental performance
and environmental protection in its operations, and regards this as an integral part of its normal
business practice. Novartis Ringaskiddy Limited is a component site of Novartis AG. Novartis AG
operates a global network of manufacturing sites, including both bulk manufacture and final dosage
formulation facilities, together with logistics facilities, and technical support functions.
Novartis AG, in common with many large multinational companies, provides central funds to its
operating units through standard financial mechanisms. Because of the likely lengthy interval between
a decision to close the Novartis Ringaskiddy Limited site and its actual closure, adequate time would
be available to ensure that an allowance for central funding would be incorporated into the site budget
to implement the CRAMP.
MDE0970Rp0013 40 Rev A01

APPENDIX A
SITE LAYOUT MAP

APPENDIX B
WASTE INVENTORY FOR 2013

5. ONSITE TREATMENT & OFFSITE TRANSFERS OF WASTE | PRTR# : P0006 | Facility Name : Novartis Ringaskiddy Limited | Filename : P0006_2013.xls | Return Year : 2013 | 28-03-2014 14:45
5 82 Please enter all quantities on this sheet in Tonnes 0
Waste
Sava
To Other Countries 06 02 05 Yes 0.033 other bases D10 M Weighed Abroad Number W0050-2 Cork,.,Ireland many 541,Germany
Within the Country 07 05 01 Yes 359.221 aqueous washing liquids and mother liquors D10 C Number P0006-03

Limited,EPA Waste Licence Corrin,Fermoy,County 06,Killaskillen,Kinnegad,Cou Killaskillen,Kinnegad,County
Within the Country 07 05 01 Yes 1722.816 aqueous washing liquids and mother liquors R2 M Weighed Offsite in Ireland Number W0050-2 Cork,.,Ireland nty Meath,MEATH,Ireland Meath,MEATH,Ireland
Services (UK)
Veolia Environmental Veolia Sotrenor,DCVC-EIM-

Services Technical Solutions FT n 2005-195,Route Route
Limited,EPA Waste Licence Corrin,Fermoy,County d'Harnes,62,Courrieres ,FR d'Harnes,62,Courrieres ,FR
To Other Countries 07 05 01 Yes 1901.675 aqueous washing liquids and mother liquors R1 M Weighed Abroad Number W0050-2 Cork,.,Ireland 62710,France 62710,France
Sava
To Other Countries 07 05 01 Yes 28.046 aqueous washing liquids and mother liquors D10 M Weighed Abroad Number W0050-2 Cork,.,Ireland many 541,Germany
Within the Country 07 05 04 Yes 249.208 mother liquors D8 E Number P0006-03
other organic solvents, washing liquids and Limited,IPPCL Register Ringaskiddy,County Cork, , 03,Ringaskiddy, ,County Ringaskiddy, ,County Cork,
Volume Calculation Onsite of generation ,Ireland Cork, ,Ireland ,Ireland

Waste

other organic solvents, washing liquids and Limited,EPA Waste Licence Corrin,Fermoy,County 06,Killaskillen,Kinnegad,Cou Killaskillen,Kinnegad,County
Within the Country 07 05 04 Yes 4647.786 mother liquors R2 M Weighed Offsite in Ireland Number W0050-2 Cork,.,Ireland nty Meath,MEATH,Ireland Meath,MEATH,Ireland
MP Storage and
Veolia Environmental Blending,WML60102,Deep
Services Technical Solutions Water Wharf,Cargo Deep Water Wharf,Cargo
Sava
other organic solvents, washing liquids and Limited,EPA Waste Licence Corrin,Fermoy,County ute,1,Brunsbuttel,25541,Ger Osterweute,1,Brunsbuttel,25
To Other Countries 07 05 04 Yes 21.545 mother liquors D10 M Weighed Abroad Number W0050-2 Cork,.,Ireland many 541,Germany

other organic solvents, washing liquids and Limited,EPA Waste Licence Corrin,Fermoy,County npark Tewnte 243,.,.,7602 243,.,.,7602
To Other Countries 07 05 04 Yes 62.02 mother liquors R2 M Weighed Abroad Number W0050-2 Cork,.,Ireland Almelo,Netherlands Almelo,Netherlands
Within the Country 07 05 10 Yes 0.3631 other filter cakes and spent absorbents D10 M Weighed Number P0006-03
Sava
To Other Countries 07 05 10 Yes 40.537 other filter cakes and spent absorbents D10 M Weighed Abroad Number W0050-2 Cork,.,Ireland many 541,Germany
ERAS ECO Limited,EPA
sludges from on-site effluent treatment Waste Licence Permit Foxhole,Youghal,County
Within the Country 07 05 12 No 745.26 other than those mentioned in 07 05 11 R1 M Weighed Offsite in Ireland Number W0211-01 Cork, ,Ireland
solid wastes containing dangerous Limited,IPPCL Register Ringaskiddy,County Cork, , 03,Ringaskiddy,County Ringaskiddy,County
Sava
solid wastes containing dangerous Limited,EPA Waste Licence Corrin,Fermoy,County ute,1,Brunsbuttel,25541,Ger Osterweute,1,Brunsbuttel,25
To Other Countries 07 05 13 Yes 13.184 substances D10 M Weighed Abroad Number W0050-2 Cork,.,Ireland many 541,Germany
Within the Country 15 01 01 No 60.26 paper and cardboard packaging R3 M Weighed Offsite in Ireland W0136-03 Cork,Ireland
Within the Country 15 01 02 No 0.14728 plastic packaging D10 M Weighed Number P0006-03

Waste
Within the Country 15 01 03 No 0.03252 wooden packaging D10 M Weighed Number P0006-03
Within the Country 15 01 03 No 39.602 wooden packaging R3 M Weighed Offsite in Ireland W0136-03 Cork,Ireland
G. Keohane Pallets
Recycling Limited,WCP-CK- Kilnap,Old Mallow
Within the Country 15 01 03 No 51.84 wooden packaging R3 M Weighed Offsite in Ireland 08-2570-01 Road,Cork, ,Ireland
(Fermoy) Limited,EPA
Waste Licence Number Cullenagh,Fermoy,County
Within the Country 15 01 03 No 33.38 wooden packaging R3 M Weighed Offsite in Ireland W0107-3 Cork, ,Ireland
Cork Metal Company
Within the Country 15 01 06 No 0.45072 mixed packaging D10 M Weighed Number P0006-03
packaging containing residues of or Limited,IPPCL Register Ringaskiddy,County Cork, , 03,Ringaskiddy,County Ringaskiddy,County
Within the Country 15 01 10 Yes 28.39577 contaminated by dangerous substances D10 M Weighed Number P0006-03
Sava
packaging containing residues of or Limited,EPA Waste Licence Corrin,Fermoy,County ute,1,Brunsbuttel,25541,Ger Osterweute,1,Brunsbuttel,25
To Other Countries 15 01 10 Yes 29.151 contaminated by dangerous substances D10 M Weighed Abroad Number W0050-2 Cork,.,Ireland many 541,Germany
Services Technical Solutions Limited,EPA Waste Licence
Within the Country 15 01 10 Yes 1.283 contaminated by dangerous substances R4 M Weighed Offsite in Ireland Number W0050-2 Cork,.,Ireland ,Fermoy,County Cork,Ireland Cork,Ireland
Services (UK)
absorbents, filter materials (including oil Limited,IPPCL Register
filters not otherwise specified), wiping Novartis Ringaskiddy Number P0006-
cloths, protective clothing contaminated by Limited,IPPCL Register Ringaskiddy,County Cork, , 03,Ringaskiddy,County Ringaskiddy,County
Within the Country 15 02 02 Yes 29.02006 dangerous substances D10 M Weighed Number P0006-03

Waste
Sava
absorbents, filter materials (including oil Veolia Environmental nlagen
filters not otherwise specified), wiping Services Technical Solutions GmbH,A51G00508,Osterwe
cloths, protective clothing contaminated by Limited,EPA Waste Licence Corrin,Fermoy,County ute,1,Brunsbuttel,25541,Ger Osterweute,1,Brunsbuttel,25
absorbents, filter materials, wiping cloths Novartis Ringaskiddy
and protective clothing other than those Limited,IPPCL Register Ringaskiddy,County Cork, ,
Within the Country 15 02 03 No 1.44815 mentioned in 15 02 02 D10 M Weighed Number P0006-03
absorbents, filter materials, wiping cloths Services Technical Solutions
and protective clothing other than those Limited,EPA Waste Licence Corrin,Fermoy,County
Within the Country 15 02 03 No 431.24 mentioned in 15 02 02 R5 M Weighed Offsite in Ireland Number W0050-2 Cork,.,Ireland

Limited,Recycling
discarded equipment containing hazardous Services Technical Solutions 003438,Cappincur Industrial Cappincur Industrial
components (16) other than those Limited,EPA Waste Licence Corrin,Fermoy,County Estate,Daingean Estate,Daingean
Within the Country 16 02 13 Yes 1.537 mentioned in 16 02 09 to 16 02 12 R4 M Weighed Offsite in Ireland Number W0050-2 Cork,.,Ireland Road,County Offaly, ,Ireland Road,County Offaly, ,Ireland
organic wastes containing dangerous Limited,IPPCL Register Ringaskiddy,County Cork, , 03,Ringaskiddy,County Ringaskiddy,County
Tradebe Fawley
Veolia Environmental Limited,ERP/FP3935KL,Cha
Services Technical Solutions rlston Charlston
gases in pressure containers (including Limited,EPA Waste Licence Corrin,Fermoy,County Road,Hardley,Southampton, Road,Hardley,Southampton,
To Other Countries 16 05 04 Yes 0.037 halons) containing dangerous substances D10 M Weighed Abroad Number W0050-2 Cork,.,Ireland SO45 3ZA,United Kingdom SO45 3ZA,United Kingdom
laboratory chemicals, consisting of or Novartis Ringaskiddy Number P0006-
containing dangerous substances, including Limited,IPPCL Register Ringaskiddy,County Cork, , 03,Ringaskiddy,County Ringaskiddy,County
Within the Country 16 05 06 Yes 13.06746 mixtures of laboratory chemicals D10 M Weighed Number P0006-03
Sava
laboratory chemicals, consisting of or Services Technical Solutions GmbH,A51G00508,Osterwe
containing dangerous substances, including Limited,EPA Waste Licence Corrin,Fermoy,County ute,1,Brunsbuttel,25541,Ger Osterweute,1,Brunsbuttel,25
To Other Countries 16 05 06 Yes 0.024 mixtures of laboratory chemicals D10 M Weighed Abroad Number W0050-2 Cork,.,Ireland many 541,Germany
Sava
discarded inorganic chemicals consisting of Limited,EPA Waste Licence Corrin,Fermoy,County ute,1,Brunsbuttel,25541,Ger Osterweute,1,Brunsbuttel,25
Sava
discarded organic chemicals consisting of Limited,EPA Waste Licence Corrin,Fermoy,County ute,1,Brunsbuttel,25541,Ger Osterweute,1,Brunsbuttel,25

Waste
Rilta Environmental
W0192-03,Grants
Rilta Environmental Grants Drive,Block Drive,Block 402,Greenogue Grants Drive,Block
Limited,EPA Waste Licence 402,Greenogue Business Business 402,Greenogue Business
Johnson Matthey
Veolia Environmental plc,VP3430BN/PCC/JMP/1
Services Technical Solutions 1/07,Orchard Orchard
spent catalysts contaminated with Limited,EPA Waste Licence Corrin,Fermoy,County Road,Royston,Hertfordshire, Road,Royston,Hertfordshire,
To Other Countries 16 08 07 Yes 10.926 dangerous substances R8 M Weighed Abroad Number W0050-2 Cork,.,Ireland SG8 5HE,United Kingdom SG8 5HE,United Kingdom
Heraeus Precious Metals
GmbH &
Co.,F44RD0069,Heraeusstr
spent catalysts contaminated with Heraeus Precious Metals Heraeusstrasse 12 - 14,.,.,D- asse 12 - 14,.,.,D-63450 Heraeusstrasse 12 - 14,.,.,D-
To Other Countries 16 08 07 Yes 84.926 dangerous substances R8 M Weighed Abroad GmbH & Co.,F44RD0069 63450 Hanau,Germany Hanau,Germany 63450 Hanau,Germany
mixture of concrete, bricks, tiles and Ashgrove Recycling,EPA Churchfield Industrial
ceramics other than those mentioned in 17 Waste Licence Number Estate,John F. Connolly
Within the Country 17 01 07 No 72.48 01 06 D5 M Weighed Offsite in Ireland W0147-01 Road,Cork, ,Ireland
Cork Metal Company
Cork Metal Company
cables other than those mentioned in 17 04 Environmental),WCP-LK-08-
Within the Country 17 04 11 No 4.4 10 R4 M Weighed Offsite in Ireland 589-01 Dublin Hill, ,Cork, ,Ireland
bottom ash and slag other than those Limited,EPA Waste Licence Corrin,Fermoy,County
Within the Country 19 01 12 No 1.92 mentioned in 19 01 11 D14 M Weighed Offsite in Ireland Number W0050-2 Cork,.,Ireland
bottom ash and slag other than those (Knockharley Knockharley,Navan,County
Within the Country 19 01 12 No 27.54 mentioned in 19 01 11 D5 M Weighed Offsite in Ireland Landfill),W0146-03 Meath,.,Ireland
Veolia Environmental Revatech

Services Technical Solutions SA,DDT35/KJ/MV,Zoning Zoning
Limited,EPA Waste Licence Corrin,Fermoy,County Industriel,Ehein,Engis,B- Industriel,Ehein,Engis,B-
Cork Metal Company
Council Waste Permit Monahan Road, ,Cork ,
Within the Country 20 01 02 No 13.74 glass R5 M Weighed Offsite in Ireland Number 08/04 ,Ireland
Services Limited,EPA Waste Forge Hill,Kinsale
Within the Country 20 01 08 No 16.95 biodegradable kitchen and canteen waste R3 M Weighed Offsite in Ireland Permit Number W0173-01 Road,Cork, ,Ireland

Waste
Sava
To Other Countries 20 01 14 Yes 0.946 acids D10 M Weighed Abroad Number W0050-2 Cork,.,Ireland many 541,Germany

Limited,Recycling
Services Technical Solutions 003438,Cappincur Industrial Cappincur Industrial
fluorescent tubes and other mercury- Limited,EPA Waste Licence Corrin,Fermoy,County Estate,Daingean Estate,Daingean
Within the Country 20 01 21 Yes 0.232 containing waste R4 M Weighed Offsite in Ireland Number W0050-2 Cork,.,Ireland Road,County Offaly, ,Ireland Road,County Offaly, ,Ireland
County Council Permit Estate,Kilkenny 01,Kilkenny
fluorescent tubes and other mercury- Number WFP-KE-08-0384- Road,Athy,County Road,Athy,County Kildare, Kilkenny Road,Athy,County
Within the Country 20 01 21 Yes 0.344 containing waste R5 M Weighed Offsite in Ireland 01 Kildare,Ireland ,Ireland Kildare, ,Ireland
Sava
paint, inks, adhesives and resins containing Limited,EPA Waste Licence Corrin,Fermoy,County ute,1,Brunsbuttel,25541,Ger Osterweute,1,Brunsbuttel,25
Holcim
Limited,EPA Waste Licence Corrin,Fermoy,County Feluy,Seneffe,B- Feluy,Seneffe,B-
To Other Countries 07 05 01 Yes 90.674 aqueous washing liquids and mother liquors R2 M Weighed Abroad Number W0050-2 Cork,.,Ireland 7181,Belgium 7181,Belgium
Holcim
other organic solvents, washing liquids and Limited,EPA Waste Licence Corrin,Fermoy,County Feluy,Seneffe,B- Feluy,Seneffe,B-
To Other Countries 07 05 04 Yes 244.62 mother liquors R2 M Weighed Abroad Number W0050-2 Cork,.,Ireland 7181,Belgium 7181,Belgium
Veolia Environmental Veolia ES

Services Technical Solutions Garston,FP3133GL,King King

Limited,EPA Waste Licence Corrin,Fermoy,County npark Tewnte 243,.,.,7602 243,.,.,7602
To Other Countries 06 01 06 Yes 0.609 other acids D10 M Weighed Abroad Number W0050-2 Cork,.,Ireland Almelo,Netherlands Almelo,Netherlands
Sava
organic halogenated solvents, washing Limited,EPA Waste Licence Corrin,Fermoy,County ute,1,Brunsbuttel,25541,Ger Osterweute,1,Brunsbuttel,25
To Other Countries 07 05 03 Yes 2.396 liquids and mother liquors D10 M Weighed Abroad Number W0050-2 Cork,.,Ireland many 541,Germany

Waste
Services (UK)
gases in pressure containers (including Limited,EPA Waste Licence Corrin,Fermoy,County Wirral,CH65 4EQ,United Port,South Wirral,CH65
To Other Countries 16 05 04 Yes 0.173 halons) containing dangerous substances D10 M Weighed Abroad Number W0050-2 Cork,.,Ireland Kingdom 4EQ,United Kingdom
Services (UK)
discarded inorganic chemicals consisting of Limited,EPA Waste Licence Corrin,Fermoy,County Wirral,CH65 4EQ,United Port,South Wirral,CH65
To Other Countries 16 05 07 Yes 0.01 or containing dangerous substances D10 M Weighed Abroad Number W0050-2 Cork,.,Ireland Kingdom 4EQ,United Kingdom

Enva Ireland Limited,W0041- Estate,Shannon,County Estate,Shannon,County Estate,Shannon,County
Within the Country 07 05 01 Yes 771.14 aqueous washing liquids and mother liquors D9 M Weighed Offsite in Ireland 01 Clare, ,Ireland Clare, ,Ireland Clare, ,Ireland
absorbents, filter materials, wiping cloths
and protective clothing other than those Greenstar Limerick,W0082- Ballykeefe Townland,Dock
Within the Country 15 02 03 No 2.92 mentioned in 15 02 02 R12 M Weighed Offsite in Ireland 02 Road,Limerick, ,Ireland
linings and refractories from non- Greenstar Environmental

metallurgical processes other than those Services Limited,EPA Waste Forge Hill,Kinsale
Within the Country 16 11 06 No 4.64 mentioned in 16 11 05 D5 M Weighed Offsite in Ireland Permit Number W0173-01 Road,Cork, ,Ireland
Roadstone Wood Limited. C Belgard

bituminous mixtures containing other than +D Recycling Facility.,WFP- Quarry,Fortunestown,Tallag
Within the Country 17 03 02 No 407.06 those mentioned in 17 03 01 R5 M Weighed Offsite in Ireland DS-11-0005-01 h,Dublin 24,Ireland
Cork Metal Company
discarded equipment containing hazardous County Council Permit Estate,Kilkenny 01,Kilkenny
components (16) other than those Number WFP-KE-08-0384- Road,Athy,County Road,Athy,County Kildare, Kilkenny Road,Athy,County
Within the Country 16 02 13 Yes 6.87 mentioned in 16 02 09 to 16 02 12 R4 M Weighed Offsite in Ireland 01 Kildare,Ireland ,Ireland Kildare, ,Ireland

Limited,Recycling
Certification Number RC-
KMK Metals Recycling Cappincur Industrial 003438,Cappincur Industrial Cappincur Industrial
discarded equipment containing Limited,Recycling Estate,Daingean Estate,Daingean Estate,Daingean
Within the Country 16 02 11 Yes 0.576 chlorofluorocarbons, HCFC, HFC R4 M Weighed Offsite in Ireland Certification Number 014904 Road,County Offaly,.,Ireland Road,County Offaly, ,Ireland Road,County Offaly, ,Ireland

discarded equipment other than those Limited,Recycling Estate,Daingean
Within the Country 16 02 14 No 0.494 mentioned in 16 02 09 to 16 02 13 R4 M Weighed Offsite in Ireland Certification Number 014904 Road,County Offaly,.,Ireland
components removed from discarded KMK Metals Recycling Cappincur Industrial

equipment other than those mentioned in Limited,Recycling Estate,Daingean
Within the Country 16 02 16 No 1.074 16 02 15 R4 M Weighed Offsite in Ireland Certification Number 014904 Road,County Offaly,.,Ireland

Waste

Within the Country 15 01 06 No 65.168 mixed packaging R1 M Weighed Offsite in Ireland W0136-03 Cork,Ireland
Within the Country 15 01 06 No 16.292 mixed packaging D5 M Weighed Offsite in Ireland W0136-03 Cork,Ireland
* Select a row by double-clicking the Description of Waste then click the delete button
Link to previous years waste data

Link to previous years waste summary data & percentage change
Link to Waste Guidance

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Novartis Ringaskiddy Limited

Annual Environmental Report 2013

Annual Environmental Report 2013

IEL Register Number P0006-03

IEL Register Number

Name and Location of the Site

Description of Activities at the Site

Company Environmental Policy

Company Organisation Chart for Environmental Management

Current Site Plan

Section 2: Summary Information:

Emissions to Atmosphere Summary

Emissions to Sewer Summary

Surface Water Emissions Report

Agency Monitoring and Enforcement

Waste Management Report

Resource Consumption Record

Reported Incidents Summary

Summary of On-Site Incineration Record

Section 3: Management of the Activity:

Environmental Expenditure Summary: Capital and Current

Environmental Management Programme - Proposal

Environmental Management Programme - Report

Schedule of Environmental Objectives and Targets - 2013 (Update)

Schedule of Environmental Objectives and Targets - 2014

Section 4: Licence Specific Reports:

Report on List I and II Substance Reductions

Tank and Pipeline Testing and Inspection Report

Noise Monitoring Report

Groundwater Monitoring Summary

Energy Audit Report

Effluent Toxicity Report

Environmental Liability Risk Assessment (Update)

Closure, Restoration and Aftercare Management Plan (Update)

Annual Environmental Report 2013

IEL Register Number P0006-03

IEL Register Number

Name and Location of the Site

Description of Activities at the Site

Company Environmental Policy

Company Organisation Chart for Environmental Management

Current Site Plan

Name and Location of Site:

Novartis Ringaskiddy Limited

Ringaskiddy, County Cork, Ireland

Description of Activities at the Site:

Industry Sector (NACE Code): D21.2

Activity: Manufacture of basic pharmaceutical products

Schedule of Activities Licensed:

Paragraph: 11.2 (c)

Paragraph 11.2 (e)

Paragraph 11.3 (b)

Company Environmental Policy:

The company's environmental policy is reproduced in full on the following page.

We care about the expectations and concerns of our stakeholders.

David Mitchell, 12-Jul-2012

Managing Director, Novartis Ringaskiddy Limited

Site Co Ordinator - Shift

CSA Engineering Stores

Also included are:

First Aid Office

GATE QUENCH TANKS COMBUSTER

STAINLESS STEEL CARBON STEEL