Roche Ireland Limited Annual Environmental Report 2008 · Roche Ireland Limited aims to achieve the...

Roche Ireland Limited

Safety & Environment, Clarecastle

Roche Ireland Limited Annual Environmental Report 2008

Roche Ireland Limited

Safety & Environment, Clarecastle

Document Location Roche Ireland Document Registry

Document Title ROCHE IRELAND Ltd ANNUAL ENVIRONMENTAL REPORT - 2008

Version Issue 11.0

File Name G:\ENVIRONMENT\4.4 IMPLEMENTATION & OPERATION\4.4.3 COMMUNICATION\4.4.3.2 LETTERS (EPA)\AER\AER 2008\AER 2008.DOC

Author(s) Jim Denieffe, Gerry Cahill

Associated Documentation

Environmental Management Programme Environmental Management Systems Manual The IPPC Licence No P0012-04

Review Reviewed by Name Signature Date

Senior Environmental Scientist

Jim Denieffe

Approval Approved by Name Signature Date

Senior Environmental Scientist

Jim Denieffe

Head of Safety & Environment

Gerry Cahill

Document History

Version Reason for Change Date effective

1.0 New 22/3/99

2.0 New AER for 1999 1/4/00

3.0 New AER for 2000 1/5/01

4.0 New AER for 2001 1/5/02

5.0 New AER for 2002 1/5/03

6.0 New AER for 2003 1/4/04

7.0 New AER for 2004 1/4/05

8.0 New AER for 2005 1/4/06

9.0 New AER for 2006 01/04/07

10.0 New AER for 2007 01/04/08

11.0 New AER for 2008 30/03/09

Contents Executive Summary ...................................................................................................................................................1 1. Introduction ...................................................................................................................................................2 1.1. Roche Ireland Environmental Policy......................................................................................2 1.2. Roche Ireland's Organisation Chart for Environmental Management ....................3 2. Report structure...........................................................................................................................................3 3. Monitoring data of emissions from the installation.......................................................................3 3.1. Emissions to Water/Sewer ........................................................................................................4 3.1.1. Final Effluent ....................................................................................................................4 3.1.2. Surface Water ..................................................................................................................5 3.1.3. Incinerator Scrubber Water........................................................................................6 3.2. Emissions to atmosphere through the Incinerator Stack and Boilers.....................7 4. Waste Analysis Summary.........................................................................................................................8 4.1 Solvent/aqueous waste for on-site incineration ..............................................................8 4.2 Solvent/aqueous waste for off-site incineration ..............................................................8 4.3 Header gas analysis.....................................................................................................................9 4.4 Sludge from Waste Water Treatment plant......................................................................10 5. Waste Management Report – Summary..........................................................................................11 5.1 On-Site Hazardous Waste Disposal ....................................................................................11 5.2 Off-site Hazardous Waste Disposal.....................................................................................12 5.3 Off-site Non-Hazardous Waste Disposal ..........................................................................15 6. Agency Monitoring and Enforcement...............................................................................................16 7. Resource Consumption Summary ......................................................................................................18 7.1. Energy Consumption.................................................................................................................18 7.2. Water Consumption...................................................................................................................18 8. Complaints Summary...............................................................................................................................19 9. Reported Incidents Summary ...............................................................................................................19 10. Environmental Management Programme .......................................................................................20 10.1 Schedule of Environmental Objectives and Targets.....................................................20 10.2 Environmental Management Programme: Review of 2008 .......................................20 10.3 Environmental Management Programme: proposal for 2009...................................29 11. Noise Monitoring Report 2008.............................................................................................................33 11.1 Introduction...................................................................................................................................33 11.2 Survey Details...............................................................................................................................33 11.3 Noise Levels at Boundary and Houses ..............................................................................36 11.4 Compliance with IPPC Limits .................................................................................................36 11.5 Comparison with Previous Years..........................................................................................36 11.6 Tonal/Impulsiveness Analysis................................................................................................36

12. Ambient Monitoring Summary ............................................................................................................39 12.1 IPPC Licence Monitoring Summary ...................................................................................39 12.2 Groundwater Monitoring Report on the Wider Site Network...................................49 13. Tank and Pipeline Testing and Inspection Report .......................................................................52 14. Bund Test Report.......................................................................................................................................52 15. Energy Efficiency .......................................................................................................................................52 16. Landfill Status Report ..............................................................................................................................53 H2 cell ...........................................................................................................................................................53 16.1 Landfill Leachate Data for 2008 ................................................................................................53 17. Landfill Monitoring Report ....................................................................................................................54 18. Resource Usage and Reduction Report...........................................................................................57 18.1 Efficiency of raw material usage in production..............................................................57 18.2 Water demand and discharge minimisation....................................................................57 19. Environmental Liabilities Risk Assessment Review.....................................................................57 19.1 Introduction...................................................................................................................................57 19.2 Programme to achieve closure ............................................................................................58 Tables Table 1: Summary of final effluent emissions to the Fergus Estuary, in 2008 .......................4 Table 2: Summary of emissions to the Fergus Estuary from the Surface Water discharge point in 2008..............................................................................................................5 Table 3: Summary of monthly loads from the surface water discharge point in 2008. .....5 Table 4: Summary of wastewater from incineration activities (2008) prior to mixing with other on-site effluent. .................................................................................................................6 Table 5: Summary of the measured emissions to atmosphere from the liquid vapour incinerator for 2008 ......................................................................................................7 Table 6: Composition of Solvent/Aqueous waste incinerated on site during 2008. ...........8 Table 7: Organic solvents sent for off-site incineration 2008 ......................................................9 Table 8: Quarterly header gas results for 2008................................................................................10 Table 9: Analysis of WWTP sludge........................................................................................................10 Table 10: Waste Summary for the period 2004-2008.......................................................................11 Table 11: Off-site Disposal or Recycling of Hazardous Waste during 2008 – Other Wastes ................................................................................................................................12 Table 12: Non-hazardous waste disposed of or recycled off-site during 2008. ...................15 Table 13: Agency data obtained for split samples of final effluent taken by the Agency from the installation. .................................................................................................16 Table 14: Agency data obtained for split samples of storm water taken by the Agency from the installation in 2008. .................................................................................17 Table 15: Energy consumption in GJ/annum for 2008. ...................................................................18 Table 16: Water consumption for 2008..................................................................................................18

Table 17: Complaints received during 2008 ........................................................................................19 Table 18: Complaints received during 2003 to 2008 ........................................................................19 Table 19: Daytime and night time noise measurements, boundary positions B1 to B9 and houses H1 to H6, 25th/26th July 2008........................................................................37 Table 20: Comparison of Night time Specific Noise Levels, (attributed to Roche) 1997-2008 boundary and houses.........................................................................................38 Table 21: Borehole data for routine parameters. Sampled 16th. May 2008 ...........................39 Table 22: Borehole data for routine parameters. Sampled 14th. Oct. 2008............................40 Table 23: Groundwater Analysis:- VOC’s (µg/l) Round 1 June 2008.........................................41 Table 24: Groundwater Analysis :- Semi volatiles (µg/l) Round 1 June 2008........................43 Table 25: Groundwater Analysis:- VOC’s (µg/l) Round 2 2nd Oct. 2008...................................45 Table 26: Groundwater Analysis :- Semi volatiles (µg/l) Round 2 2nd Oct. 2008 ..................47 Table 27: Landfill Leachate Analytical Data for 2008 ......................................................................53 Table 28: Boundary Drain Analytical Data for 2008 .........................................................................54 Table 29: Landfill Gas Monitoring for 2008 .........................................................................................54 Figure 1: Flow Diagram of Likely Order of Full Site Closure ........................................................59 Annex 1: Monthly data for effluent discharge to Fergus Estuary Annex 2: Data set for emissions to atmosphere from incinerator and notification review Annex 3: Noise Monitoring Locations Annex 4: AER/PRTR 2008

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Executive Summary

Roche Ireland Ltd. operates to IPPC Licence No. P0012-04. The following is a summary of the contents of the AER. Further details are available in the full report. Emissions to Water Roche treated effluent is emitted to the Fergus Estuary at Emission Point 15. Table 1 contains analytical details of the of the emissions for 2008. All licenced parameters are monitored in accordance with Schedule C.2.2 of the IPPC Licence, P0012-04. In every case the results are well within the emission limit values set out in Schedule B.2 of the licence. The results of independent monitoring carried out by the EPA on three occasions in 2008 are shown in Table 13. All parameters are well within the emission limit values. Emissions to Air Emissions to air from the liquid/vapour incinerator occur at Emission point 16. Table 5 contains analytical details of the of the emissions to atmosphere in 2008. Continuous monitoring is carried out as per Schedule C1.1 of the licence and the emission limit values are detailed in Schedule B.1 of the licence. In every case the emissions are well within the licenced requirements. Waste Management Table 10 shows a summary of all waste produced on site with comparisons to previous years. 2008 continues the trend in waste reduction. Table 11 shows details of all hazardous waste generated on site and shipped off site for treatment or recycling. Table 12 shows details of the continued emphasis being placed on recycling. A new waste management barcode system will be introduced in 2009 to further improve the efficiency of waste management on site. Water Consumption Water consumption continues to be reduced year on year due to continued emphasis on the reduction of water usage/ waste. (Table 16). Energy Consumption The efficient use of energy is continually emphasised on site. In 2008 Roche Ireland was accredited the IS393 Energy Management Standard, by the NSAI. Roche Ireland was also awarded a responsible care award from Roche Corporate as a result of on-going energy improvements. Continued focus on energy management has resulted in ongoing improvements. (Table 15). .

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1. Introduction

Roche Ireland Register Number: P0012-04 The Roche Ireland plant, a bulk pharmaceutical facility, is located in the village of Clarecastle, Co. Clare, on a 79 acre site, National Grid Reference E1353-N1738. Roche Ireland is both an ISO 14001:2004 and IS393:2005 accredited site. Reporting date for the site is 31st March annually. 1.1 Roche Ireland Environmental Policy

Roche Ireland Limited aims to achieve the highest standards of environmental performance in the interests of all our stakeholders, be they employees, owners, neighbours, the public at large or the natural environment itself. We will make every effort to fully comply with the terms of our Integrated Pollution Prevention and Control Licence and with other applicable and relevant environmental legislation. We will adhere to the principles of Responsible Care and will pursue a policy of continuous improvement in the implementation of its associated codes. These codes will be referenced in the register of aspects and the site's objectives and targets. We reiterate our commitment to Pollution Prevention which comprises one of these codes. By preparing and implementing environmental policies, systems and procedures and regularly reviewing them at senior management level, we will administer a continuous improvement programme designed to minimise the impact of our operations on the environment. The company's environmental aspects register will be reviewed on a regular basis and environmental objectives and targets will be set accordingly. Progress against these will be reviewed regularly and results will be shared with management and employees. The environmental implications of introducing new processes and products will be carefully evaluated and cleaner technologies will be utilised where possible. Waste avoidance and waste reduction and minimisation initiatives will be vigorously pursued, in accordance with the best eco-efficiency practices. Materials and energy used in manufacturing and associated activities will be carefully conserved. This will be done by optimising product yield, maximising the recycle of materials where this is feasible and eliminating, leaks, spills and reworks. We will ensure that processes are safe by subjecting them to rigorous hazard analysis and by administering comprehensive training to operating staff. Emergency procedures and equipment will be maintained in readiness to minimise the impact of any accidents that could occur and to safeguard the environment. Emergency crews will continue to be trained in techniques for dealing with incidents. ______________________ Managing Director

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1.2 Roche Ireland's Organisation Chart for Environmental Management

2. Report Structure The structure of this report follows the requirements of IPPC licence P0012-04 and the

guidance given in the EPA Guidance Note for the Annual Environmental report. 3. Monitoring Data of Emissions From the Installation

Licence Requirement: Condition 5 of the IPPC licence requires Roche Ireland Ltd to ensure that the emissions from the installation do not exceed the emission limit values set out in Schedule B: Emission Limits of the licence. This requires self monitoring of the emissions in accordance with condition 6 of the IPPC licence; this condition requires that the requirements of Schedule C and clauses within condition 6 for the sampling, analyses, measurements, examinations, maintenance and calibrations are met.

Dr. Frank Cox, Managing Director

Joe Murphy Director of Regulatory Compliance

Gerry Cahill Head of Safety and Environment

Des Ryan Director of Operations

Mattie McDonagh Head of Facilities

Sean Rodgers Facilities Administrator

Una Dardis

Facilities Engineer

Tony Barrett Facilities Coordinator

Jim Denieffe Snr. Environmental Scientist

Diarmuid McSweeney Michael Daly

Nicky Moloney Environmental Scientists

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3.1 Emissions to Water/Sewer

Licence requirements: Condition 5.1 sets out that no emission from the installation shall exceed the emission limit values set out in Schedule B of the IPPC licence.

3.1.1 Final Effluent

Data for the final effluent emissions in 2008 are shown below in table 1. Data for the period 2004-2007 is shown for comparison purposes. The full monthly data set for final effluent emissions is included as Annex 1.

Emission Reference Point: 15

Compliance level with the terms of the licence is 100%. Table 1: Summary of final effluent emissions to the Fergus Estuary, in 2008

Parameter Licence Limits (kg)

Mass Emissions (kg) 2004



Mass Emissions (Kg) 2007

Mass Emissions (Kg) 2008

Volume treated effluent to the Fergus Estuary (m3)

255,500 139,686 136,212 125,434 123,917 140,794

BOD 182,500 44,869 24,974 15,655 9,665 15,446

COD 584,000 335,817 270,177 180,835 44,564 35,096

Phosphate (P) 2,920 121 94 1,06.3 107 102

Nitrogen (N) 2,920 194 230 246.9 81 195

Heavy Metals (Kg) - 0 61.9 67.1 11.4 20

Total Suspended Solids

45,625 10,975 5,401 3,861 3,452 1,806

Bromide (Br-) 1,314,000 N/A N/A 529,169 8,713 6,155

Phenols 146 0 0.6 0 0 0

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3.1.2 Surface Water

Emission Reference Point: SW1. Table 2: Summary of emissions to the Fergus Estuary from the Surface Water discharge point in 2008.

Parameter IPPC licence limits Average monthly concentration

Average monthly load

Total annual load emitted

Flow. - 5,566 m³ 66,793 m³

pH pH Range: 6.0 to 9.0

7.8 - -

TOC 150 mg/L 40.1 mg/l 182.3 Kg 2187.6 Kg

Table 3: Summary of monthly loads from the surface water discharge point in 2008.

Total organic

carbon (Kg)

Volume discharged

m³

January 268 18553

February 127.2 5256

March 280 7563

April 194.3 3512

May 226 3005

June 110.8 5400

July 37.1 1411

August 241.8 7402

September 117 3961

October 459 6686

November 61.9 3612

December 65 2532

Totals 2188.1 66793

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3.1.3 Incinerator Scrubber Water

Emission Reference Point: W2.

Table 4: Summary of wastewater from incineration activities (2008) prior to mixing with other on-site effluent.

Parameter Licence Limits Maximum concentration

mg/L

Maximum concentration emission

mg/L

Number of occasions over ELV

Total suspended solids 30 - 45 18 0

Mercury and its compounds, expressed as mercury

0.03 0.0001 0

Cadmium and its compounds, expressed as cadmium

0.05 0.0004 0

Thallium and its compounds, expressed as thallium

0.05 0.0013 0

Arsenic and its compounds, expressed as arsenic

0.15 0.016 0

Lead and its compounds, expressed as lead

0.2 0.002 0

Chromium and its compounds, expressed as chromium

0.5 0.067 0

Copper and its compounds, expressed as copper

0.5 0.012 0

Nickel and its compounds, expressed as nickel

0.5 0.008 0

Zinc and its compounds, expressed as zinc

1.5 0.034 0

Dioxins / furans 0.3 ng/L 0.0485 ng/l 0

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3.2 Emissions to Atmosphere Through the Incinerator Stack and Boilers

Emission point: 16

Data for 2004 - 2007 are included for comparison purposes. An account of reported incidents relating to the liquid vapour incinerator is included in Annex 2. Compliance level: 100%

Table 5: Summary of the measured emissions to atmosphere from the liquid

vapour incinerator for 2008

Parameter Licensed Mass

Emissions (kg)

Total Mass emissions (kg) 2004





Average hourly stack flow m3/hour 30,000 m3 8,491 9,007 9,875 8,721 7,190

Sulphur dioxide 13,140 633 616 157 132 136

Nitrogen Oxides 26,280 7,716 7,891 10,025 7,607 5,688

Particulates 2,628 84 49 130 82 90

Carbon dioxide - 33,026,000 12,946,676 24,269,275 26,571,000 25,157,000

VOC halogenated - - - - - -

VOC Non-halogenated 2,628 78 67 47.99 31 36

Hydrogen Chloride 2,628 61 59 66 59 67

Carbon monoxide 13,140 39 70 97 164 102

Annual Dioxins/Furans (Averaged) mg 26.3 mg

0.58 (Max measured 0.79 mg) 3.3 mg (max) 2.9 mg 2.9 0.43

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4. Waste Analysis Summary 4.1 Solvent/Aqueous Waste for On-Site Incineration

Licence requirement: Schedule C.4 requires monitoring of the liquid waste input to the incinerator.

Table 6: Composition of Solvent/Aqueous waste incinerated on-site during 2008.

Component Calorific value

kJ/kg

2008

weight (tonnes)

Water 103.52

Methanol 19500 518.39

Acetone 30850 285.86

Ethyl Acetate 25513 659.7

Isopropyl alcohol (IPA)

33080 4.89

Ethanol 26960 66.92

Dichloromethane (DCM)

7735 181.41

Heptane 48046 0.16

Tetrahydrofuran (THF)

32725 87.56

Toluene 42450 71.94

Hexane 48342 236.39

Others 4.12

Total 2,220.87

4.2 Solvent/Aqueous Waste for Off-Site Incineration

Licence requirement: Schedule C.4 requires monitoring of the liquid waste sent for off-site incineration.

The weights of individual solvents are calculated for each consignment against its net weight. The annual mass of individual organic solvents sent off-site during 2008 is given in Table 7.

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Table 7: Organic solvents sent for off-site incineration 2008.

Substance Units Annual mass

Acetone tonnes 62.18

Dichloromethane tonnes 70.28

Ethyl acetate tonnes 90.19

Ethanol tonnes 37.89

Hexane tonnes 19.24

Methanol tonnes 510.29

Tetrahydrofuran tonnes 21.33

Toluene tonnes 16.09

IPA tonnes 6.66

Heptane tonnes 2.46

Other tonnes 47.04

Water tonnes 1068.32

TOTAL tonnes 1951.96

4.3 Header Gas Analysis

Licence requirement: Schedule C.4 requires quarterly monitoring of the gaseous

input to the incinerator.

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Table 8: Quarterly header gas results for 2008

Substance Units 20/03/08 26/08/08 29/09/08 10/11/08

Acetone mg/Nm3 4 4.5 20 34

Methyl chloride mg/Nm3 < 1.0 < 0.9 < 0.6 < 1.0

Dichloromethane mg/Nm3 277 280 4 96

Ethyl acetate mg/Nm3 69 <0.3 680 5860

Ethanol mg/Nm3 26 44 13 70

Hexane mg/Nm3 2937 227 440 8000

Methanol mg/Nm3 20 7.7 <0.2 < 0.3

Tetrahydrofuran mg/Nm3 440 682 40 5.0

Toluene mg/Nm3 2447 2447 4520 590

Chlorine % w/w 3.75 6.4 6.4 0.6

4.4 Sludge from Waste Water Treatment Plant

Licence requirement: Schedule C.4 requires quarterly monitoring of the sludge from the WWTP for organic matter and water content.

Sludge from the WWTP is analysed for water content by loss on drying and for organic matter content by loss on ignition.

Previously the Loss on Drying was reported as Dried Solids Content. Table 9: Analysis of WWTP sludge

Substance Units 08/01/08 01/04/08 29/07/08 17/10/08

Loss on drying % w/w 86% 85% 85% 86%

Loss on ignition % w/w 89% 87% 90% 88.5%

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5. Waste Management Report – Summary Table 10: Waste Summary for the period 2004-2008

Waste 2004 (tonnes)

2005 (tonnes)

2006 (tonnes)

2007 (tonnes)

2008 (tonnes)

Total waste produced 28,719 20,461 28,936.52 8,898.97 5353

Total waste disposed of on-site 4,039 3,363 54.28 0 0

Total waste disposed of off-site 3,164 2,093 4,912.54 4,049.09 3501.07

Total waste recovered on site 21,103 13,786 23,164.63 4,356.57 989

Total waste recovered off-site 413 1,224 805.07 493.31 862.93

Quantity of non-hazardous waste produced

1,006 760 2,428.2 1383 1032.225

Non hazardous waste disposed of on-site 523 371 54.28 0 0

Non-hazardous waste disposed of off-site 105 98 2,079 997 609.07

Non-hazardous waste recovered on-site

0 0 0 0 0

Non-hazardous waste recovered off-site 378 291 295 386 423.155

Quantity of hazardous waste produced

27,713 19,706 26,508.32 7,515.97 4320.775

Hazardous waste disposed of on-site 3,516 2,992 0 0 0

Hazardous waste disposed of off site

3,059 1,995 2,834.01 3,052.09 2892

Hazardous waste recovered on-site 21,103 13,786 23,164.63 4,356.57 989

Hazardous waste recovered off-site 35 933 509.68 107.31 439.775

5.1 On-Site Hazardous Waste Disposal

The hazardous waste generated is not disposed of on the Roche site; it either is used as fuel (energy recovery) in the on-site incinerator or is sent off-site for energy recovery, recycling or re-use. Section 4 refers to the composition of the waste, either liquid or gaseous, used for on-site energy recovery as fuel for the incinerator.

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5.2 Off-site Hazardous Waste Disposal

See Table 7 for breakdown of Solvent waste disposed of off-site in 2008.

Table 11: Off-site Disposal or Recycling of Hazardous Waste during 2008 – Other Wastes

Description EWC Code Weight (Tonnes)

Contractor Disposal Method

Nerolin still bottoms from Tetrahydrofuran/Toluene recovery containing Toluene and 6-methoxynaphthalene

070508* 120 AVG Incineration

Carbon and mofetil 070510* 45396 AVG Incineration Silica gel and mofetil 070510* 24336 AVG Incineration Lab waste 070513* 12358 AVG Incineration Dicyclohexylurea/Acetone 070513* 13475 AVG Incineration Incinerator ash 070513* 900 AVG Incineration Sump cleanings 070599* 2390 AVG Incineration Drummed liquid waste 070501* 3301 AVG Incineration Drummed liquid waste 070503* 14380 AVG Incineration Drummed liquid waste 070504* 12184 AVG Incineration Bales of fibre drums 150110 33740 AVG Incineration Empty contaminated drums 150110 2580 AVG Incineration Plastic drum liners/ppe 150110 88130 AVG Incineration Cuno Filters 150202 13478 AVG Incineration Airhandling filters 150202 4159 AVG Incineration Empty paint cans 150110 2720 AVG Incineration Waste paint, PPE and brushes 80111 280 AVG Incineration Obsolete inorganic chemicals(sodium sulphite, Magnesium turnings, silica gel, celite)

160507 50 AVG Incineration

Obsolete organic chemicals 160508 990 AVG Incineration Obsolete chemicals(acid) 060106* 260 AVG Incineration Osmosis filters 150202 230 AVG Incineration PPE, liners and empty uncleaned bags that previously contained sodium hydroxide powder (BASIC)


Synthetic Lubricant (Mobil SHC 630) 130206* 160 AVG Incineration Triphenylphosphine 070513* 120 AVG Incineration Sodium Hydroxide Powder (BASIC) 060204* 40 AVG Incineration Air compressor filters contaminated with lubricating oils

070513* 40 AV G Incineration

Silica-alumina and Waste pharmaceutical powders (retain samples) including nicardipine hydrochloride, THL-Hydroxy-beta-lactone and Orlistat


PPE, liners and empty uncleaned bags that previously contained sodium hydroxide powder (BASIC)


Drum containing Ethylene 99.5% 160504 10 AVG Incineration Drum containing Magnesium granules, Copper powder Copper turnings


Drum containing Zinc powder 160507 10 AVG Incineration

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Drum containing Chromium (VI) Oxide 99.9%, Chromium Trioxide [ACIDIC]


Lab Smalls containing Potassium dichromate and potassium chromate [LIMITED QUANTITIES]


Lab Smalls containing Hydrogen Peroxide, 27.5% Sol in water [LIMITED QUANTITIES}


Lab Smalls containing Platinum (IV) oxide, Platinum dioxide, Potassium peroxodisulfate, Calcium hypochlorite Bismuth oxynitrate, Silver nitrate, Lithium perchlorate acs reagent


Lab Smalls containing Potassium hydrogen di-iodate [LIMITED QUANTITIES]


Lab Smalls containing Ammonium Persulphate, Tetrapropylammonium perruthenate


Potassium Hexachlorplatinate (IV) [ACIDIC] [LIMITED QUANTITIES]


Lab Smalls containing Isobutyl chloroformate and N,N,N,N-Tetramethyl-1,6 hexane diamine. [BASIC]


Lab Smalls containing Piperidine, Di-n-butylamine, N,N-Dimethyloctylamine. [BASIC]


Containing Mercury [NO SEG] 060404 10 AVG Incineration Lab Smalls containing Bromine. [ACIDIC] 060106 10 AVG Incineration Limited Quantities of Class 5.1 containing Phosphomolybdic acid hydrate


Lab Smalls containing Epibromohydrin, Methyl chloroacetate, 1,3-Dicyclohyxylcarbodiimide


Lab Smalls containing 1,10-phenanthroline, 4-Chloro-7-nitrobenzofurazan


Lab Smalls containing Lactonitrile, O-toluidine, Brucine, Mercuric Acetate, Mercuric Chloride and Sodium Fluoride


Lab Smalls containing 2,3 Dimethylanilline, Methyl Dichloroacetate, Sodium cyanide, copper(I) cyanide, Pentachlorophenol and 4-Dimethylaminopyridine


Containing Silica-aluminium catalyst support grade, 135


Lab smalls containing Sodium Nitrate 0.1N. [No Seg]


N,N-Dicyclohexylcarbodiimide 070513 880 AVG Incineration Plastic Liners/PPE contaminated with Nicardipine hydrochloride(200L)


Lab Waste - sharps,vials,clothing(200L) 070513 380 AVG Incineration Air handling filters contaminated with Nicardipine hydrochloride(FIBC)


PTH-Aminoalcohol 070513 110 AVG Incineration Triphenylphosphine 070513 140 AVG Incineration DAD-1 Chloro: Methyl 1-(2-chloroethyl)-3-methoxycarbonyl-2-pyrroleacetate)


GPS –Cyanopyrimidine (GPS-01) 070513 10 AVG Incineration GPS -Guaiacolether (GPS-03) 070513 230 AVG Incineration

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Saquinavir 070513 90 AVG Incineration Bentronite Acid-leached powder (filtrol) 160303 60 AVG Incineration Mycophenolate Mofetil 070513 780 AVG Incineration Mycophenolic Acid 070513 580 AVG Incineration Cyclohexanecarboxylic acid sodium salt 070513 50 AVG Incineration 4-Dimethylaminopyridine 070513 50 AVG Incineration THL-Hydroxy-beta-lactone 070513 310 AVG Incineration Quinaldic acid 070513 80 AVG Incineration Sodium dithionite 070513 30 AVG Incineration Asparagine monohydrate 070513 170 AVG Incineration Isobutyryl chloride 070504 210 AVG Incineration Sulconazole nitrate 070513 150 AVG Incineration Mibefradil Dihydrochloride 070513 130 AVG Incineration Nicardipine Hydrochloride 070513 150 AVG Incineration Dimethyl 1,3 acetonedicarboxylate [DAD] 070504 40 AVG Incineration Isopropyl acetate 070504 50 AVG Incineration Sodium sulphite 070513 990 AVG Incineration Ethyl acetate 070504 80 AVG Incineration Ethanol solution 070504 390 AVG Incineration Tetrahydrofuran 070504 160 AVG Incineration Morpholine 070504 30 AVG Incineration Methyl tert butyl ether 070504 390 AVG Incineration Benzoyl chloride 160305 750 AVG Incineration Isobutyryl chloride 070504 1270 AVG Incineration Empty contaminated steel drums 150110 13000 enva recycling Empty contaminated plastic drums 150110 1130 enva recycling COD Vials 060404* 180 enva recycling WEEE 200135 10 rehab recycling N,N-Dicyclohexylcarbodiimide 07 05 13 270 AVG Incineration Thionyl Chloride. [ACIDIC] 060106 310 AVG Incineration Trimethylacetyl Chloride (Pivaloyl Chloride). [ACIDIC]


Potassium Carbonate 060205 210 AVG Incineration Waste sodium chloride 07 05 13 320 AVG Incineration Contaminated electrical cables 07 05 99 400 AVG Incineration Diluted Ansulite (fire-fighting foam) 160508 6400 AVG Incineration Plastic Liners/PPE contaminated with Nicardipine hydrochloride(FIBC)

15 01 10 100 AVG Incineration

Non cooking oil 130205 2300 enva recycling

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5.3 Off-site Non-Hazardous Waste Disposal Table 12: Non-hazardous waste disposed of or recycled off-site during 2008.

Description EWC code Weight (tonnes)

Disposal method Waste Contractor

Domestic Refuse landfilled off-site

20 03 01 75.09 landfill Clean Ireland

Construction Waste landfilled off-site

17 09 04 14.46 landfill Clean Ireland

Construction Waste landfilled off-site

17 09 04 145.98 landfill Martin's construction

Glass 15 01 07 2.6 recycling Rehab

Scrap/Timber pallets 15 01 03 20.04 recycling Connaught timber

Scrap/Timber pallets 15 01 03 23.8 recycling Clean Ireland

Scrap/Timber pallets 15 01 03 52.54 recycling Wood systems

Plastics/shrink wrap 15 01 02 1.82 recycling Clean Ireland

Plastics-uncontaminated plastic drum lids,pallets and drums

15 01 02 11.92 recycling JFC plastics

Cardboard 15 01 01 8.19 recycling Clean Ireland newsprints 20 01 01 0.82 recycling Greenstar

Office waste paper (inc. archive docs for destruction)

20 01 01 8.6 recycling Shred-it

Metal drum rings 20 01 40 6.84 recycling Galway metal

Scrap metal 20 01 40 285.645 recycling Galway metal

Printer toner cartridges 08 03 18 0.24 recycling Clean Ireland

cooking oil 20 01 25 0.1 recycling MT oils

Wet sludge from WWTP 07 05 12 373.54 Incineration AVG

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6. Agency Monitoring and Enforcement The Agency took samples from the facility on 3 occasions during 2008 as indicated

below. Table 13: Agency data obtained for split samples of final effluent taken by the

Agency from the installation.

Parameter Units Specification Results

26/02/08 13/05/08 27/08/08

pH -- 6.0-9.0 8.21 8.41 8.19

COD mg/L 4000 mg/L 283 331 119

BOD mg/L 1250 mg/l - 12.0 3.0

Suspended solids

mg/L 250 mg/L 72 35 8.0

Ammonia – N

mg/L 10 mg/L 0.184 < 2.0 0.561

Total Phosphorus

mg/L 20 mg/L 0.29 < 0.20 1.54

Nitrate –N mg/L 10 mg/L 0.5 - 0.2

Nitrite mg/L -- 0.141 0.020 0.121

Total Ox. Nitrogen

mg/L -- 0.61 - 0.37

Total Nitrogen

mg/L -- 9.67 4.83 4.34

Chloride mg/L -- 1300 3696 2460

Bromide mg/L 9000 mg/L 29.7 10.5 47.6

Sulphate mg/L 1200 mg/L 26.8 19.1 15.2

Phenols mg/L 1 mg/l 0.027 0.03 0.04

Be µg/L - <0.5 < 5.0 < 5.0

Fe mg/L - 2.34 - -

Mn µg/L - 0.180 - -

Bo mg/L - - - -

Se µg/L - < 1.0 34.2 139

Cd mg/L - - - -

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Parameter Units Specification Results

26/02/08 13/05/08 27/08/08

As µg/L - < 1.0 8.8 37.9

Sb µg/L - 0 < 1.0 < 1.0

Cr mg/L - 0.02 0.021 0.020

Cu mg/L - 0.037 0.096 0.057

Ni mg/L - 0.047 0.014 0.10

Pb mg/L - < 0.001 < 0.001 < 0.001

Zn mg/L - 0.030 0.033 0.025

VOC µg/L - 26.6 68

Mo mg/L - - -

Hg µg/L - < 0.10 < 0.10 < 0.10

Th Mg/L - - - -

Tin mg/L - - - -

Tl mg/L - - - -

Appearance - - - -

Dioxins . furans

Ng/m3 0.1 ng/m3 - - -

Table 14: Agency data obtained for storm water from the installation in 2008.

Parameter Units Specification 26/02/08 13/05/08 27/08/08

pH -- 6.0-9.0 7.42 7.66 8.52

COD mg/l - 156 44 275

TOC Mg/l - 26.6 11.1 59.8

Appearance - - No colour. Low turbidity. No surface film. No solids

Pale straw colour. V slight turbidity. A few dark solids. No surface film.

Colourless. No turbidity. No gross solids. No surface film.

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7. Resource Consumption Summary

Licence requirement: Condition 7 of the IPPC licence is aimed at ensuring efficient use of resources and energy in all site operations. Clauses within this condition address energy efficiency audits, energy efficiency, reduction in water demand and efficiency of raw materials usage.

7.1 Energy Consumption

The table below compares energy consumption data for 2008 with the preceding years 2003 to 2007.

Table 15: Energy consumption in GJ/annum for 2008.

Source of the energy 2003 2004 2005 2006 2007 2008

Natural gas 6,907 69,453 108,953 94,393 100,264 102,956

Fuel Oil 96,688 6,375 2,997 880 697 190

Coal 0 0 0 0 0 0

Liquid wastes 43,775 60,125 52,330 79,520 67,992 56,682

Gaseous wastes 41,446 56,902 41,354 33,093 20,742 13,174

Electricity 96,952 99,670 86,411 89,107 74,038 66,628

7.2 Water Consumption

The table below compares water consumption data for 2008 with the preceding years 2003 to 2007.

Table 16: Water consumption for 2008.

2003 2004 2005 2006 2007 2008

On-site Ground Water 0 0 0 0 0 0

On-site surface water 0 0 0 0 0 0

Municipal supply m³ 229,760 231,943 222,336 219,131 190,525 178,180

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8. Complaints Summary

Licence requirement: Condition 11.4 requires Roche Ireland Ltd to record all complaints of an environmental nature related to the operation of the plant and to record the response made in each case.

During 2008 there was one complaint received from a member of the local community (Table 18). During 2008 there were no major incidents on site resulting in complaints or environmental damage.

Table 17: Complaints received during 2008

Date Category Cause Actions

11/01/08 Odour Complaint of odour from local resident. Investigation showed that it may have originated from a process being carried out in the pilot plan.

Carbon replaced in the scrubber unit. Complainant invited to site to witness the new controls put in place.

Table 18: Complaints received during 2003 to 2008

2003 2004 2005 2006 2007 2008

Odour 3 1 0 0 1 1

Noise 0 2 0 1 0 0

Water 0 0 0 1 0 0

Air 0 0 0 1 0 0

Procedural 0 0 0 0 0 0

Miscellaneous 0 0 0 1 0 0

Note: Anonymous complaints or complaints that cannot be validated are not considered to be valid by the company.

9. Reported Incidents Summary

Licence requirement: Condition 11 and its clauses require Roche to record incidents. Condition 9 states the requirements for accident prevention and emergency response. There were no major incidents on site during 2008 resulting in damage to the environment. Other minor reportable incidents were reported to the Agency and are referred to elsewhere in the report.

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10. Environmental Management Programme

Licence Requirement: condition 2.2 and its clauses of the IPPC licence requires the licencee to maintain an Environmental Management System (EMS). As part of this requirement an Environmental Management Programme is required. 10.1 Schedule of Environmental Objectives and Targets

Eight objectives were identified for the site in 2008:- Objective 1: Groundwater and Surface water protection Objective 2: Residuals Management Plan & Environmental Liabilities Objective 3: Resource efficiency Objective 4: Wastewater treatment plant Objective 5: Protection of the atmosphere Objective 6: Waste management Objective 7: Environmental Management Objective 8: Community Relationships

10.2 Environmental Management Programme: Review of 2008

1.0 Objective: Protect Surface Water, Soil and Groundwater

Target No.

IPPC licence condition

Target Result Responsibility

1.1 6.11 To control Ground water migration and monitor its quality. Groundwater will be pumped from 4 wells to the WWTP where it will be treated to reduce TOC concentrations.

Ongoing Head of Facilities

Biannual checks on the well heads to be implemented. URS to report on well heads

Complete Environment

1.2 6.11 A monitoring and reporting system will be established to ensure groundwater pumping from wells 401,402,403 and 404 is maintained at all times in accordance with licence requirements.

Daily volumes of groundwater pumped will be recorded


1.3 3.6 Ongoing bund management programme to ensure that all bunds meet requirements of IPPC 3.6: suitability and capacity of tank and drum storage areas.

Ongoing Head of Maintenance

1.4 3.6.5 Develop a standard specification for bund design for implementation on all new or altered bunds in accordance with IPPC requirements

On hold Head of Projects

1.5 3.6 Develop local controls and accountability to ensure the emptying of bunds is carried out in accordance with site procedures

SOP in place. Sampling ongoing

Operations/Environment.

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1.0 Objective: Protect Surface Water, Soil and Groundwater

Target No.



1.6 6.1 Ensure appropriate controls are employed to prevent Plant drains overflowing thereby potentially contaminating storm water

Ongoing Operations/Environment/Head of Facilities

1.7 Use and manage the 06 Catch and release for floor drains to prevent overfill of floor drains and buffer any accidental releases

Complete Head of Facilities

1.8 Ensure all routine and non routine activities in the Facilities area are assessed in terms of potential for surface water infiltration and implement suitable controls. The impacts of compressor and boiler house operations in particular need to be assessed.


1.9 Develop an appropriate response to the potential for storm water contamination which does not compromise the firewater retention capacity

Ongoing Environment/Head of Facilities

1.10 3.6 All drums to be moved to and from the production buildings shall be stored in an area impervious to the contents should they be released. No liquids shall be stored in the driveways unless in a manner where any potential losses are contained.

Ongoing Director Manufacturing

1.11 7.3 Water conservation: Conduct a feasibility report on the possible recycling of storm water and effluent within the plant

To be considered in 2009

Facilities/Environment

1.12 6.11 As part of the ongoing bund management programme check the integrity of the surface water liner

Not done in 2008

Head of Maintenance

1.13 6.11 Establish a means of checking the integrity of the floor drains/collection system

Not done in 2008

Head of Maintenance

1.14 2.1.2 Training of forklift drivers in storm water protection in the event of spillage. Increase awareness among staff of job specific environmental considerations.

Include in training plan for 2009.

Environment/Training department

1.15 6.1 Conduct a survey for API levels in the site final effluent

Complete Environment/Technical services

1.16 HCL tank storage bund upgrade Complete Head of Maintenance

1.17 6.10 Prevent surface water from the possibility of contamination which could be caused by leaking transfer lines. Enhanced risk management.

Ongoing Head of Maintenance.

1.18 To maintain and improve the management on the underground drains. CCTV survey and repairs plan

Survey in 2008. Improvements planned for 2009

Head of Maintenance

1.19 6.11 Prevent spillages to ground during forklift fuelling and waste oil loading

No spillages recorded in 2008. Review current system status.

Head of Facilities

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2.0 Objective: Residuals Management Plan & Environmental Liabilities

Target No.


Plan Result Responsibility

2.1 10 Prepare and submit a construction quality assurance plan for the capped landfill


2.2 10 Carryout the landscaping of the capped landfill Complete. Projects

2.3 10 Progress remediation of H2 area, obtain credit application approval

Work planned for 2009

Environment/ Facilities/projects

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3.0 Objective: Resource Efficiency

Target No.


Plan Result Responsibility

3.1 7.2 Enhance the management of site’s consumption of energy resources.

Obtained registration to IS 393 in 2008.

Director of Facilities

3.2 7.0 Direct and control energy usage within every business function by achieving accreditation to IS393 energy management system

Complete Energy Management Team

3.3 7.4 Pursue waste avoidance, reduction and minimization vigorously in accordance with best eco-efficiency practices. Materials and energy used in site operations will be carefully conserved.

Goals in place and regular monitoring

Operations

3.4 7.4 Establish waste minimisation, structure, organisation, programme and joint goals led by the Env. Team. Regular EMP meetings with waste minimisation as an agenda item with three waste minimisation site review meetings to discuss progress and exchange ideas and achievements.

.

Site EMP in place Environment

3.5 7.4 Enhanced resource management:: Minimize the use of filters on site by optimizing their operation.

Ongoing Head of Maintenance.

3.6 7.4 Develop mass balances for all site processes and present in a simplified waste map so that inputs outputs and losses are readily identifiable.

Mass balance in place. Waste maps not updated.

Environment

3.7 084007 Evaluate wind-power as an alternative . Obtain planning permission and erect the necessary wind speed analysis installation.

Wind speed pilot tower installed and trials commenced.

Project put on hold Project Manager

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4.0 Objective Wastewater Treatment Plant Management

Target No.



4.1 Authorisation and approval protocol for all waste streams introduced to the WWTP. Evaluate new or reintroduced waste streams in accordance with BREF.

System in place Head of Environment

4.2 Develop an annual plan for 2008 waste streams based on production plan and disposal route (offsite, incineration, WWTP).

Waste stream management ongoing

Environment/ Production/ Facilities

4.3 Agree and document acceptance criteria for waste streams with Operations and Facilities

Ongoing Environment

4.4 Develop a Quality implementation plan addressing continuous improvement in ISO 17025, Inter-calibration and microbiology.

QIP in place. Head of Environment

4.5 7.4 Engage an external consultant to benchmark best practices in WWTP management. Hold regular meetings with all party representation i.e. SHE,/ Facilities/Multi-products. Visit two other facilities.


4.6 7.4 Develop a plan for the reduction of sludge kg per BOD kg treated.

Complete. MLSS reduced to 2500 mg/l

Facilities/Environment

4.7 064029 Further improve the efficiency of the WWTP by completion of project for piping macerator and CTW overflows so as to eliminate any possible negative impact on WWTP or volumes

Ensure that possible CTW overflows and waste from the macerator are piped to Eq. Tanks

Complete Facilities

4.8 074044 Inline ammonia meters TKN and TOC meters

To improve control/performance of the WWTP

Complete Facilities/Projects

4.9 074020 Re piping the multi products waste streams Not done in 2008

4.10 Further improve the efficiency of the WWTP by reviewing/improving the methodology used for sampling of waste for dispatch to Facilities from Operations.

Develop plan for reviewing sampling of the waste tanks to ensure representative waste samples.

Ongoing Manufacturing

4.11 Improved control on nutrient additions to Eq. Tanks

Fit timers to pumps for phosphoric acid and urea charge tanks.

Complete Facilities.

4.12 084004 Improve decanter performance

Optimise decanter operations & install turbidity meter on decanter centrate

Performance improved in 2009. Facilities Engineer

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5.0 Objective Protection of the Atmosphere

Target No.



5.1 5.2 Conduct a risk assessment of odour risks and controls for each operational area, Implement a site wide monitoring and reporting programme.

Complete actions identified in odour risk assessments

Qtr. 2/Ongoing

Ongoing. One complaint received in 2008.

Environment/Operational Areas

5.2 7.2 CO2 is the most significant air emission contributor to the site eco-balance. The Energy Management Programme is key to meeting the Roche corporate CO2 environmental performance target of 10% by 2010.

Qtrly reports on performance of the Energy Programme.

CO2 reduction in 2008. Registration to IS 393

Head of Environment/ Facilities

5.3 Implement a consistent approach to the recording and investigation of vent lifts during incinerator shut down

Improvement in process. Facilities

5.4 6.7 Prepare a programme for the identification and reduction of fugitive emissions

Started. Programme to be completed in 2009.

Environment/Operations

5.5 5.2 To enhance the management/control of possible dust emissions to air and prevent the emission of API’s to atmosphere from the on site dust collectors.

Monitor the alarmed pressure differential monitoring system on points 9 to 13 in accordance with schedule C1.1. Investigate possibility of interlocking the alarm to the fan. Qtr 2 - ongoing

Monitoring in place. Environment/ Operational areas

5.6 084005 Reduce emissions resulting from mixing of LTC with cooling tower water and subsequent emissions at the cooling tower..

Install NIR probes to give early warning of LTC losses to cooling towers and link to control systems

LTC losses reduced through ongoing monitoring.

Tech Services/Facilities

5.7 5.1 HCFC capital project planned. Replacement of HCFC’s plant wide planned by 2010.

K6 plan being implemented.

Facilities Director

5.8 084018 Replace the incinerator refractory brick Complete Maintenance /Facilities

5.9 084005 Upgrade the NIRA pipe work and controls on PCTW

Enhance the management of risk of MeOH losses and ensure ongoing compliance with IPPC.

Project deferred. Maintenance/Facilities

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6.0 Objective Waste Management

Target No.



6.1 8.3 Segregate ,manage and present waste streams such that the objectives of the bar-coding project is successful

Complete. Bar-coding to be fully implemented in early 2009

Manufacturing

6.2

6.3 Develop the PRTR proposal and to compile the PRTR to meet the Legislative requirement

Complete Head of Environment

6.4 Maintain a record of solvent inputs and outputs for each plant area.

Ongoing Manufacturing

6.5 Continuous improvement: Examination of current sampling and waste solvent analytical methods for accuracy and precision.

Action arising from audits of waste contractors

Samplers installed to prevent layering occurring in tanks.

Head of Technical Services / Q.C

6.6 074047 Bar coding of the waste management area waste streams from the production plant

Ongoing in 2008. to be completed in early 2009.

Facilities.

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7.0 Objective Ongoing EMP activities for Environmental Management

Target No.



7.1 2.1.2 Build awareness, inform and consult area teams such that local EMPs are developed in such a way as is consistent with the site EMP, thereby meeting corporate and legal requirements.

Implement site training on sustainability and waste minimisation in the production areas, maintenance and contractors.

EMP completed annually

Environment

7.2 2.1 Conduct a site environmental training needs analysis and develop an implementation plan.

Meet with the individual areas to develop plan.

Full training plan to be implemented in 2009

Environment

7.3 2.2 Review and update (as required) the register of Aspects.


7.4 2.1 Promote environmental awareness through site wide communication of key figures on a regular basis using available channels and area EMP meetings

Ongoing Environment

7.5 6.1.3 Meet the requirements of the recently introduced PRTR as part of the annual environmental report


7.6 To meet the ISO 14001 requirement for internal audits to check the performance of the EMS

Full set of audits completed in early 2009.

Head of Environment

7.7 2.2 Management review of EMS Complete Head of Environment

7.8 Establish the feasibility of a local area eco-balance to allow area comparisons and demonstrate improvements i.e. scoring the area waste map

Deferred Environment/ Operational areas

7.9 Develop a data collection system which simplifies the collation of data for CSE key figures, AER and site sustainability reports. Information management: Improve data collation systems for CSE in line with the PWC report

Data collection and reporting improved. Ongoing

Facilities/Logistics/Environment

7.10 2.2 Develop the legal register database to demonstrate compliance with requirements

Ongoing Environment

7.11 2.2 Review and update environmental SOPS in accordance with the Condor document management schedule

Complete. Progress reported monthly

Environment

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Ongoing EMP activities for Community Relationships Responsible care code: Community Awareness and Emergency Response

Target No.



7.12 Issue the following reports report. as part of the Communication programme :

AER; ,CSE key figures and the sustainability report.


7.13 To continue the involvement with the local community by regular communication

To hold at least 3 Community Liaison Group (CLG) meetings during 2007


7.14 Communication: Facilitate the sharing of information and monitoring of local EMP implementation progress by holding regular meetings with operational area.

Ongoing Environment

7.15 5.2 To proactively respond to community concerns by monitoring noise and odour on site and to reduce the risk of complaints.

Monthly Noise and odour surveys

Complete. Ongoing monitoring in place.

Head of Environment

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10.3 Environmental Management Programme: proposal for 2009 1.0 Waste Minimisation

TARGET No PLAN TARGET FOR CALENDAR YEAR RESPONSIBILITY

1.1 New process introduction: CETP.

Achieve the target yields for each step in the CETP process in the current GMP7 campaign. Report on performance to plan.

CETP Project Manager

1.2 New waste stream assessment

Evaluate possibility of on site treatment for the sodium hydroxide scrubber solutions from the CAT 12 and CAT 13 processes (currently sent off site). Develop options for when CETP becomes a commercial product


Head of Environment.

1.3 New waste stream: reuse/recycle

Develop options for reuse/recycling of the CAT 12 concentrated sulphuric acid stream. Develop working relationship with outside company.




Work with PTDA Basel to develop route for the TPPO waste from the CAT 25 process step.



Examine the potential for solvent recovery of the solvents used when CETP becomes a commercial product.


1.6 New waste stream: treatment

Monitor the volumes of CAT 11 and CAT 12 aqueous streams produced . Demonstrate that the streams can be effectively treated in the WWTP.



1.7 Establish Quarterly Waste Minimisation Meetings for Facilities group.

Identify and prioritise savings. Goal is to save 50K in 2009.

Head of Facilities

1.8 Enable waste reduction from the production plants.

Carry out a Kaizen event in the Facilities area involving Production and Environmental Lab personnel on the waste streams being generated and their disposal routes. Specific targets tbd.

Head of Facilities.

1.9 Product yield improvement

Arising from Kaizen event in 2008, goal set for yield improvement in MMF production.

04 Plant Manager.

1.10 Product yield improvement

Improve Orlistat yields. 05 Plant Manager

1.11 Reduce LTC losses Put action plan in place to address losses of LTC. Plan in place Q1 and

04/05 Plant Manager

07 Plant Manager

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monthly report on progress Head of Facilities.

1.12 Material use reduction

Reduce carbon charge from 100 to 75 kg.

04 Plant Manager

1.13 Chinagrin yield improvement

Set up Kaizen event to examine possible yield improvements

07 Plant Manager

2.0 Waste Water Treatment Plant

TARGET NO. PLAN TARGET FOR CALENDAR YEAR

RESPONSIBILITY

2.1 Increase efficiency in the management of the WWTP

Improve the use of PAT (NH3, TOC, TKN) in the running of the plant to achieve project benefits.

Head of Facilities


2.2 Improve efficiency in the Environmental Lab.

Carry out review of all analyses carried out by the lab. Set targets to achieve efficiency gain

Head of Environment

2.3 Maintain the level of MLSS at the optimum for the volume of waste being produced/fed forward.

Monitor and maintain the MLSS at the target level. Significant savings possible.

Head of Facilities


2.4 Improve efficiency of the decanter operation.

Installation of turbidity meter on the decanter in order. Monitor the quantity of sludge disposed of.

Head of Facilities


2.5 WWTP Operation efficiency. Evaluate which of the three cells is the most cost effective and operationally effective

Head of Facilities


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3.0 Energy

TARGET No PLAN TARGET FOR CALENDAR YEAR

RESPONSIBILITY

3.1 Drive continuous improvement in energy utilization

Retain registration to IS393 Energy/Maintenance Manager

3.2 Reduce the volume of water consumed.

High: 158000m³

Target: 165575 m³

Low: 174000m³

Energy/Maintenance Manage

3.3 Monitor and reduce Electricity usage

High: 16834 MWHrs

Target: 17200

Low: 17550


3.4 Monitor and reduce Gas usage

High: 29390 MWHrs

Target: 30000

Low: 30610


(gas fig has allowance of 455 MWHrs for expected use in plant shut)

3.5 Obtain MCERTS registration for stack monitoring equipment

Obtain registration by Q4 Head of Facilities

3.6 Improve energy efficiency of toluene distillation process

Combine two distillations into one

04 Plant Manager

3.7 Energy reduction Replace existing heating system in Engineering, Training Centre and Contractors Canteen with Solar powered system.

Energy/Maintenance Manager

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4.0 Projects

TARGET No PLAN TARGET FOR CALENDAR YEAR

RESPONSIBILITY

4.1 Refrigeration system upgrade in line with K6

Complete in 2009 Head of Facilities

4.2 Improve waste management control

Barcode system for waste. Q1

Head of Facilities

4.3 Complete capping of H2 area per plan agreed by EPA.

Capping complete Q4. Head of Facilities

4.4 Establish H2 area monitoring schedule.

Set up monitoring programme of the Nature ponds during the project. Set up baseline study in line with EPA requirements

Head of Environment

4.5 Improve management of 04 CTW

Pipe 04 CTW run off to the 04 waste tank as part of K6 project.

Head of Facilities

4.6 Improved underground drainage system

Carry out improvements identified from CCTV survey

Head of Maintenance

4.7 Reduce/eliminate possibility of plant dust extract entering the environment

Carry out actions identified in K1 Gap Analysis

07 Plant Manager

4.8 Reduction in air emissions Upgrade the Pilot Plant Scrubber System.

Head of Technical Services.

4.9 Maintenance upgrade and improved containment

Upgrade MP and 04 Plants heating batteries and condensate piping

07 Plant Manager

04 Plant Manager

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11. Noise Monitoring Report 2008

11.1 Introduction An environmental noise survey was commissioned by Roche Ireland Ltd to fulfil

the requirements for an annual noise survey as specified in the IPPC licence Reg No. P0012-04 from the Environmental Protection Agency.

The survey was undertaken in July 2008. It consisted of measurement of noise levels around the plant boundary and at nearby residences, by day and by night.

11.2 Survey Details

Methodology The survey methodology was in accordance with ISO 1996 "Description and measurement of environmental noise", and the EPA Environmental Noise Survey Guidance document (2003). Measurement Locations Nine boundary measurement locations and six house locations were surveyed. These locations are marked in Figure 1 and are as follows: Boundary Locations

B1 At car park entrance to graveyard

B2 At entrance to Roche, near ESB substation

B3 Between training centre and O4 labs

B4 Near Quay Road gate

B5 At Roche sign, facing plant

B6 Facing main plant building

B7 At north corner of effluent plant

B8 Near tank farm, towards boundary

B9 Not accessible due to earthworks, measured at nearest point on access road, as shown in Figure 1

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House Locations

H1 At No. 36, Beechwood

H2 Bungalow on Clare Hill, beside “Greenlawn”

H3 At rear of houses on Patrick Street, accessed from lane

H4 Quay Rd.

H5 Hilltop cottage on N18, on right hand side in direction of Shannon

H6 Cottage fronting N18, on left hand side in direction of Shannon

The noise levels at houses were assessed by measurement where there was

public access, generally within 20 metres of the house.

Measurement Parameters The measurement parameters for assessing environmental noise levels are LAeq, LA90, LA50 and LA10. These were measured at all locations.

The objective of the survey was to quantify the specific noise levels due to noise

emissions from the plant. The method of determining plant specific noise level is outlined below:

Description of Noise Parameter best representing specific noise from plant

Plant noise dominant, no other significant noise sources

LAeq

Intermittent interfering noise (e.g. birds, traffic, wind), with underlying plant noise audible

LA50 if plant clearly audible, with occasional interference from other noise sources or LA90 if plant not clearly audible, i.e. continual interfering noise

Plant barely audible (i.e. not immediately noticeable, unless actively listening) Plant not audible

< LA90 (up to 5 dB lower) Not Detectible (ND) <<LA90 (more than 5 dB lower than LA90)

The determination of plant specific noise as described above was verified by correlation of the live sound level meter readings with the audible sound.

Investigation of tonal content at houses at night time was done subjectively, and by 1/3-octave real-time analysis.

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Instrumentation

Manufacturer Instrument Calibrated by

Calibration reference

Last Laboratory Calibration

Brüel & Kjær SLM 2250-L

Class1 serial no. 2579999

Bruel & Kjaer

Certificate of conformance

2579999

19/03/2007

Svantek SLM 947

(Type 1)

serial no. 5283

AV Calibration 0806337 09/06/2008

Castle Calibrator GA 607 serial no. 040520

AV Calibration No. 0708323 31/08/2007

Note: In accordance with EPA guidance, sound measurement instrumentation is calibrated at a certified laboratory every two years. Laboratory calibrations for the ANV Technology instrument stock is staggered, so that at any time there is always one instrument which is no more than one year from primary laboratory calibration. Regular comparison calibrations are carried out in-house between instruments to verify that there is no drift in calibration.

The measurement duration was 15 minutes at boundary locations, and 30 minutes at house locations.

Survey Times and Meteorological Conditions:

Daytime 24th July 2008. Wind: west, Beaufort 1 to 2 (light), dry, 18 ºC.

The night time survey was conducted on the 24th /25th July 2008. Wind: west, Beaufort 0 to 1 (calm to light), dry, 14 ºC.

Plant Operating Conditions

The plant was in normal production during the surveys.

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11.3 Noise Levels at Boundary and Houses

Results of the daytime and night time noise measurements at the plant boundary and nearby houses are presented in the following tables:

Table 21. Daytime and night time Noise Measurements, Boundary and

Houses

Table 23. Specific Noise Levels, Boundary and Houses 1997 to 2008

11.4 Compliance with IPPC Limits The IPPC night time noise limit of 45 dB(A) applies at noise sensitive locations, i.e.

the closest houses to Roche. The night time noise limit was complied with at all house locations.

(See table 1) The IPPC daytime noise limit of 55 dB(A) applies at noise sensitive locations, i.e. the

closest houses to Roche. The daytime noise limit was complied with at all house locations. (See table 1)

The specific night time noise levels attributable to Roche at the houses were in the

range 29 dB(A) to 45 dB(A), and within the night time noise limit of 45 dB(A). The highest plant noise level detected at a house was 45 dB(A) at H4 (Quay Road).

11.5 Comparison with Previous Years

A comparison between the night time noise levels attributed to the Roche plant from 1996 to 2008 is presented in Table 3.. The variations in noise levels at the houses, in recent years are within the normal range expected for field measurements, carried out under varying climatic conditions.

11.6 Tonal/Impulsiveness Analysis The 1/3 octave frequency analysis at house and boundary locations is given in

Appendix B. Subjectively the noise was broadband in character at all residential locations. There was no tonal features observed at measurement locations.

The plant noise was non-impulsive at all locations.

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Table 19: Daytime and night time noise measurements, boundary positions B1 to B9,

and houses H1 to H6, 25th and 26th July 2008.

Measured Noise Level dB(A) 1 Location

See Map Time

LAeq LA90 LA50 LA10 Specific 2 Comment

Nighttime

B1 01:13 48 46 47 49 46 Steady low level plant noise

B2 01:10 50 49 50 51 49 Steady plant noise, intermittent traffic noise.



B5 23:50 48 47 48 49 47 Steady plant noise & intermittent traffic





H1 02:08 40 39 40 41 39 Low level plant noise and intermittent distant traffic.



H4 02:47 47 45 46 47 45 Steady low level plant noise, occasional car pass by.

H5 03:30 59 35 36 44 35 Steady low level plant noise audible, occasional

distant car.

H6 02:52 34 29 31 36 29 Low level plant noise, occasional distant car,

rain drops.

Daytime

B1 13:35 52 49 51 53 49 Steady plant noise, distant traffic noise.

B2 13:30 53 49 51 55 49 Steady plant noise, local cars.

B3 11:00 52 51 52 53 51 Steady low level plant noise from Louvre opposite,

distant traffic, birdsong.

B4 11:20 49 46 48 51 46 Steady plant noise from main building, trees in breeze,

birdsong.

B5 11:25 50 49 50 52 49 Steady plant noise from Roche.

B6 11:38 47 45 46 49 45 Steady plant noise, intermittent distant traffic,

tree movement in breeze.

B7 11:50 53 51 51 54 51 Steady low level plant noise, hedge trimming nearby.

B8 12:05 49 44 46 49 44 Steady low level plant noise, hedge trimming nearby.

B9 12:20 51 48 50 53 48 Steady plant noise, trees in breeze, aircraft noise.

H1 13:56 50 44 46 52 44 Steady low level plant noise, local traffic,

dogs barking, trees in breeze.

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H2 15:10 55 46 49 56 46 Steady low level plant noise from Roche,

distant intermittent traffic, birdsong, trees in breeze.

H3 14:35 52 48 50 55 < 48 Low level plant noise barely audible in lulls, tree movement in breeze, birdsong, local traffic, aircraft.

H4 15:45 50 46 48 52 < 46 Low level plant noise barely audible in lulls,

trees in breeze, local and distant traffic.

H5 16:51 54 47 51 57 << 47 Trees in breeze, distant N18 traffic, Roche not audible.

H6 16:21 72 48 63 75 << 48 Roadside position, local traffic, birdsong,

Roche not audible.

1 measurement period was 15 minutes at each boundary position, and 30 minutes at houses 2 component of noise attributable to Roche

Table 20: Comparison of Night time Specific Noise Levels, (attributed to Roche) 1997-2008 boundary and houses

1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008

49 49 54 51 49 49 45 48 49 50 49 46

42 48 51 50 50 50 48 49 44 46 49 49

52 52 54 54 57 52 57 56 46 56 54 52

47 43 45 44 50 46 46 45 46 47 46 45

51 46 55 51 52 51 50 51 52 51 49 47

53 52 56 57 55 55 53 54 50 55 51 51

58 57 54 56 55 59 56 56 55 54 51 50

49 49 51 49 46 49 53 51 47 49 49 45

46 46 50 50 41 41 46 48 44 43 44 42

37 41 44 43 44 42 39 39 36 41 44 39

38 42 41 44 45 44 41 42 38 40 43 40

42 38 37 46 42 41 42 44 40 41 40 42

45 40 42 46 45 44 45 45 45 45 43 45

42 33 32 42 41 38 39 37 36 43 37 35

43 31 28 42 45 35 41 37 40 42 37 29

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12. Ambient Monitoring Summary

Licence requirement: Schedule C.6 details the monitoring frequency and parameters for groundwater monitoring across the site. There are two biannual surveys conducted; one by Roche covering the boreholes and groundwater wells specified in the IPPC licence and the other conducted by URS over the wider borehole network across the site to examine the migration and concentration of historic solvents. 12.1 IPPC licence monitoring summary

The nine IPPC ambient monitoring locations were sampled on 16th. May and 14th. October 2008.

Table 21: Borehole data for routine parameters. Sampled 16th. May 2008

COD mg/L Ammonia mg/L

TOC mg/L pH Conductivity mS

D2 96 12 25 6.66 4.06

E2 67 8.6 21 6.60 5.28

F2 42 1.0 9.0 6.93 2.66

G2 57 4.3 14 7.32 1.89

H2 28 0.8 6.0 6.86 0.87

401 64 5.0 10 7.11 2.59

402 35 1.2 7.0 6.43 2.57

403 86 12 20 6.55 4.89

404 66 2.7 11 6.69 1.65

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Table 22: Borehole data for routine parameters. Sampled 14th October 2008

COD mg/L

Ammonia mg/L

TOC mg/L

pH Conductivity mS

D2 84 11 186 6.92 3.73

E2 46 - 180 7.33 4.0

F2 16 0.3 94 7.01 2.27

G2 35 3.1 131 6.94 1.77

H2 - - 21 8.21 0.12

401 45 4.1 103 7.14 2.10

402 11 0.4 91 6.95 0.76

403 70 8.9 192 7.01 4.24

404 44 2.1 116 7.12 1.43

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Table 23: Groundwater Analysis:- VOC’s (µg/l) Round 1 June 2008

Monitoring Well BH401 BH402 BH403 BH404 H2 G2 F2 E2 D2

Dichlorodifluoromethane - - - - - - - - -

Chloromethane - - - - - - - - -

Vinyl Chloride - - - - - - - - -

Bromomethane - - - - - - - - -

Chloroethane - - - - - - - - -

Trichlorofluoromethane - - - - - - - - -

trans-1,2-Dichloroethene - - - - - - - - -

Dichloromethane - - - - - - - - -

Carbon disulphide - - - - - - - - -

1,1-Dichloroethene - - - - - - - - -

1,1-Dichloroethane - - - - - - - - -

tert-butyl methyl ether - - - - - - - - -

cis-1,2-Dichloroethene - - - - - - - - -

Bromochloromethane - - - - - - - - -

Chloroform - - - - - - - - -

2,2-Dichloropropane - - - - - - - - -

1,2-Dichloroethane - - - - - - - - -

1,1,1-Trichloroethane - - - - - - - - -

1,1-Dichloropropene - - - - - - - - -

Benzene - - - - - - - - -

Carbontetrachloride - - - - - - - - -

Dibromomethane - - - - - - - - -


Bromodichloromethane - - - - - - - - -

Trichloroethene - - - - - - - - -

cis-1,3-Dichloropropene - - - - - - - - -

trans-1,3-Dichloropropene - - - - - - - - -


Toluene 0.007 - 0.004 0.003 0.002 - 0.003 0.003 0.0041,3-Dichloropropane - - - - - - - - -

Dibromochloromethane - - - - - - - - -

1,2-Dibromoethane - - - - - - - - -

Tetrachloroethene - - - - - - - - -

1,1,1,2-Tetrachloroethane - - - - - - - - -

Chlorobenzene - - - - - - - - -

Ethylbenzene - - - - - - - - -

p/m-Xylene - - - - - - - - -

Bromoform - - - - - - - - -

Styrene - - - - - - - - -


o-Xylene - - - - - - - - -

1,2,3-Trichloropropane - - - - - - - - -

Isopropylbenzene - - - - - - - - -

Bromobenzene - - - - - - - - -

2-Chlorotoluene - - - - - - - - -

Propylbenzene - - - - - - - - -

4-Chlorotoluene - - - - - - - - -

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1,2,4-Trimethylbenzene - - - - - - - - -

4-Isopropyltoluene - - - - - - - - -


1,2-Dichlorobenzene - - - - - - - - -


sec-Butylbenzene - - - - - - - - -

tert-Buylbenzene - - - - - - - - -


n-Butylbenzene - - - - - - - - -

1,2-Dibromo-3-chloropropane - - - - - - - - -

1,2,4-Trichlorobenzene - - - - - - - - -

Naphthalene - - - - - - - - -


Hexachlorobutadiene - - - - - - - - -

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Table 24: Groundwater Analysis :- Semi volatiles (µg/l) Round 1 June 2008

Monitoring Well BH401 BH402 BH403 BH403 H2 G2 F2 E2 D2 Acenaphthene - - - - - - - - -

Acenaphthylene - - - - - - - - -

Anthracene - - - - - - - - -

Azobenzene - - - - - - - - -

Benzo(a)anthracene - - - - - - - - -

Benzo(a)pyrene - - - - - - - - -

Benzo(b)fluoranthene - - - - - - - - -

Benzo(ghi)perylene - - - - - - - - -

Benzo(k)fluoranthene - - - - - - - - -

Bis(2-chloroethoxy)methane - - - - - - - - -

Bis(2-chloroethyl)ether - - - - - - - - -

Bis(2-ethylhexyl)phthalate - - - - - - - - -

4- Bromophenylphenylether - - - - - - - - -

Butylbenzylphthalate - - - - - - - - -

Carbazole - - - - - - - - -

4- Chloro-3-methylphenol - - - - - - - - -

4- Chloroaniline - - - - - - - - -

2- Chloronaphthalene - - - - - - - - -

2- Chlorophenol - - - - - - - - -

4- Chlorophenylphenylether - - - - - - - - -

Chrysene - - - - - - - - -

Dibenzo(a,h)anthracene - - - - - - - - -

Dibenzofuran - - - - - - - - -

1,2- Dichlorobenzene - - - - - - - - -



2,4- Dichlorophenol - - - - - - - - -

Diethyl phthalate - - - - - - - - -

Dimethyl phthalate - - - - - - - - -

2,4- Dimethylphenol - - - - - - - - -

Di-n-butylphthalate - - - - - - - - -

2,4- Dinitrotoluene - - - - - - - - -

2,6- Dinitrotoluene - - - - - - - - -

Di-n-octylphthalate - - - - - - - - -

Fluoranthene - - - - - - - - -

Fluorene - - - - - - - - -

Hexachlorobenzene - - - - - - - - -


Hexachloroethane - - - - - - - - -

Hexchlorocyclopentadiene - - - - - - - - -

Indeno(123-cd)Pyrene - - - - - - - - -

Isophorone - - - - - - - - -

2- Methylnaphthalene - - - - - - - - -

2- Methylphenol - - - - - - - - -

4- Methylphenol - - - - - - - - -

Naphthalene - - - - - - - - -

2- Nitroanaline - - - - - - - - -

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3- Nitroaniline - - - - - - - - -

4- Nitroaniline - - - - - - - - -

Nitrobenzene - - - - - - - - -

2- Nitrophenol - - - - - - - - -

4- Nitrophenol - - - - - - - - -

N-nitrosodi-n-propylamine - - - - - - - - -

Pentachlorophenol - - - - - - - - -

Phenanthrene - - - - - - - - -

Phenol - - - - - - - - -

Pyrene - - - - - - - - -

2,4,5- Trichlorophenol - - - - - - - - -


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Table 25: Groundwater Analysis:- VOC’s (µg/l) Round 2 Oct. 2008 Monitoring Well 401 402 403 404 H2 G2 F2 E2 D2

Dichlorodifluoromethane - - - - - - - - -

Chloromethane - - - - - - - - -

Vinyl Chloride - - - - - - - - -

Bromomethane - - - - - - - - -

Chloroethane - - - - - - - - -

Trichlorofluoromethane - - - - - - - - -

trans-1,2-Dichloroethene - - - - - - - - -

Dichloromethane - - - - - - - - -

Carbon disulphide - - - - - - - - -

1,1-Dichloroethene - - - - - - - - -

1,1-Dichloroethane - - - - - - - - -

tert-butyl methyl ether - - - - - - - - -

cis-1,2-Dichloroethene - - - - - - - - -

Bromochloromethane - - - - - - - - -

Chloroform - - - - - - - - -


1,2-Dichloroethane - - - - - - - - -


1,1-Dichloropropene - - - - - - - - -

Benzene - - - - - - - - -

Carbontetrachloride - - - - - - - - -

Dibromomethane - - - - - - - - -


Bromodichloromethane - - - - - - - - -

Trichloroethene - - - - - - - - -

cis-1,3-Dichloropropene - - - - - - - - -

trans-1,3-Dichloropropene - - - - - - - - -


Toluene - - - - - - - - -


Dibromochloromethane - - - - - - - - -

1,2-Dibromoethane - - - - - - - - -

Tetrachloroethene - - - - - - - - -


Chlorobenzene - - - - - - - - -

Ethylbenzene - - - - - - - - -

p/m-Xylene - - - - - - - - -

Bromoform - - - - - - - - -

Styrene - - - - - - - - -


o-Xylene - - - - - - - - -

1,2,3-Trichloropropane - - - - - - - - -

Isopropylbenzene - - - - - - - - -

Bromobenzene - - - - - - - - -

2-Chlorotoluene - - - - - - - - -

Propylbenzene - - - - - - - - -

4-Chlorotoluene - - - - - - - - -

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4-Isopropyltoluene - - - - - - - - -




sec-Butylbenzene - - - - - - - - -

tert-Buylbenzene - - - - - - - - -


n-Butylbenzene - - - - - - - - -

1,2-Dibromo-3-chloropropane - - - - - - - - -


Naphthalene - - - - - - - - -



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Table 26: Groundwater Analysis :- Semi volatiles (µg/l) Round 2 Oct. 2008

Monitoring Well 401 402 403 404 H2 G2 F2 E2 D2 Acenaphthene - - - - - - - - -

Acenaphthylene - - - - - - - - -

Anthracene - - - - - - - - -

Azobenzene - - - - - - - - -

Benzo(a)anthracene - - - - - - - - -

Benzo(a)pyrene - - - - - - - - -

Benzo(b)fluoranthene - - - - - - - - -

Benzo(ghi)perylene - - - - - - - - -

Benzo(k)fluoranthene - - - - - - - - -

Bis(2-chloroethoxy)methane - - - - - - - - -

Bis(2-chloroethyl)ether - - - - - - - - -

Bis(2-ethylhexyl)phthalate - - - - - - - - -

4- Bromophenylphenylether - - - - - - - - -

Butylbenzylphthalate - - - - - - - - -

Carbazole - - - - - - - - -

4- Chloro-3-methylphenol - - - - - - - - -

4- Chloroaniline - - - - - - - - -

2- Chloronaphthalene - - - - - - - - -

2- Chlorophenol - - - - - - - - -

4- Chlorophenylphenylether - - - - - - - - -

Chrysene - - - - - - - - -

Dibenzo(a,h)anthracene - - - - - - - - -

Dibenzofuran - - - - - - - - -




2,4- Dichlorophenol - - - - - - - - -

Diethyl phthalate - - - - - - - - -

Dimethyl phthalate - - - - - - - - -

2,4- Dimethylphenol - - - - - - - - -

Di-n-butylphthalate - - - - - - - - -

2,4- Dinitrotoluene - - - - - - - - -

2,6- Dinitrotoluene - - - - - - - - -

Di-n-octylphthalate - - - - - - - - -

Fluoranthene - - - - - - - - -

Fluorene - - - - - - - - -

Hexachlorobenzene - - - - - - - - -


Hexachloroethane - - - - - - - - -

Hexchlorocyclopentadiene - - - - - - - - -

Indeno(123-cd)Pyrene - - - - - - - - -

Isophorone - - - - - - - - -

2- Methylnaphthalene - - - - - - - - -

2- Methylphenol - - - - - - - - -

4- Methylphenol - - - - - - - - -

Naphthalene - - - - - - - - -

2- Nitroanaline - - - - - - - - -

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3- Nitroaniline - - - - - - - - -

4- Nitroaniline - - - - - - - - -

Nitrobenzene - - - - - - - - -

2- Nitrophenol - - - - - - - - -

4- Nitrophenol - - - - - - - - -

N-nitrosodi-n-propylamine - - - - - - - - -

Pentachlorophenol - - - - - - - - -

Phenanthrene - - - - - - - - -

Phenol - - - - - - - - -

Pyrene - - - - - - - - -



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12.2 Groundwater monitoring report on the wider site network Groundwater from seventeen selected monitoring wells was sampled by URS in June 2008. Sampling was conducted in accordance with strict URS protocol to minimise the risk of cross-contamination between sample events and maintain sample integrity. The samples were analysed for a site specific suite of four compounds – tetrahydrofuran (THF), toluene, dichloromethane (DCM) and acetone.

Compared to the November 2007 results and previous monitoring results, concentrations of the four site-specific contaminant compounds in June 2008 have remained relatively low across the site. A total of seventeen monitoring wells were sampled from across the site in June 2008. The main concentration increases of note between November 2007 and June 2008 were: THF Well 517 from <0.005 mg/L to 0.415 mg/L; Well 21 from 0.1 mg/L to 0.495 mg/L; Well 401 from <0.005 mg/L to 0.01 mg/L. Toluene Well 301 from <0.005 mg/L to 8.5 mg/L; Well 302 from 5.1 mg/L to 41 mg/L; Well 21 from <0.005 mg/L to 17 mg/L; Well 216 from 6 mg/L to 84 mg/L. The main concentration decreases of note in June 2008 were: THF Well 302 from 3.2 mg/L to <0.01 mg/L; Well 216 from 0.8 mg/L to 0.615 mg/L; Well 702 from 0.8 mg/L to 0.135 mg/L. DCM Well 216 from 0.52 mg/L to <0.3 mg/L.

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The following points summarise the June 2008 Hydraulic containment monitoring round results: Acetone was below reporting limits in all monitoring wells across the site, suggesting that the net flux of acetone to the River Fergus via groundwater flow in June 2008 is zero. Concentrations of toluene ranged from below detection (wells 207, 308 and G2) to 84 mg/L in the H2 landfill area. Elevated concentrations of toluene were detected in well 21 (17 mg/L) and well 216 (84 mg/l) in the H2 landfill area. In the Production Area, toluene was detected in wells 301 and 302 at elevated concentrations of 8.5 mg/L and 41 mg/L respectively. The low levels of toluene detected (not greater than 0.007 mg/L) along the down-gradient site boundary in June 2008 suggest that toluene is being attenuated by biodegradation and/or sorption along the groundwater flow path to the site boundary. The net flux of toluene to the River Fergus via groundwater flow is inferred to be negligible in June 2008. Whilst THF is not adsorbed or biodegraded as readily as toluene, in June 2008 it was only detected at a trace concentration in well 401 (0.01 mg/L) along the down-gradient site boundary. The increases in THF concentrations in the landfill area in December 2005 are considered to have been due to the mobilisation of contamination following trial pitting in this area in mid-2005. The THF concentrations site-wide declined substantially in May 2007 and have remained low in the subsequent monitoring rounds up to June 2008.

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.

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13. Tank and Pipeline Testing and Inspection Report

Underground Storm water/Foul Sewer Inspection Pipe Relining / Repairs at Roche Ireland. A full inspection of all underground services was carried out using CCTV in 2008. While no significant deterioration has occurred since the last survey (2005/2006) that would pose any concerns with containment, we have identified a programme of work to further improve integrity and this will take place in 2009.

14. Bund Test Report Our inspection strategy is in place to inspect every concrete containment bund for leak tightness and mechanical integrity. This is carried out on an annual basis & the schedule was fully complied with. Two bunds, #1 & #3 were upgraded as per our 2008 EMP. Our SOP was updated to ensure compliance with the current IPPC license conditions and observations regarding documented close out of remediation activities were improved.

15. Energy Efficiency

2008 Electricity Consumption Reduced by 6.4% 2008 Natural Gas Consumption Reduced by 8.5% 2008 Water Consumption Reduction 2.9% Achieved IS393 accreditation Achieved >98% Employee Awareness training sessions 2009 Initiatives/Plan: Electricity, Gas and Water Consumption Target <3% 2008 Actual

• Develop “Utilities on demand” concept further and implement any opportunities that arise

• Repeat Steam trap survey and continue to improve thermal efficiencies

• Quarterly Compressed Air/N2 leak survey using Ultrasonic Technology

• Continue with occupancy lighting switches.

• Incinerator at 850 C.

• Maintain accreditation to Energy Management System IS393

• Continue with Employee suggestion scheme & implement opportunities as they arise

• Implement operational changes to aeration cells in WWTP that will deliver significant reductions in electricity consumption.

• Implement Refrigeration Upgrade to comply with Corporate directive K6 which will also generate energy reduction opportunities

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16. Landfill Status Report

Following the completion of the landfill capping project in 2007 the area covering cells 3,4,5,6,7 was landscaped with various types of shrubs and grassed areas. Leachate pumping and groundwater monitoring programs continue as normal in the area. Cells 1,2 will be landscaped in early 2009.

H2 cell The H2 cell is an unlined cell, which received a variety of wastes commencing in 1977. Extensive soil and groundwater investigations have been undertaken since 1985. Based on these investigations and other available information, RPS consultants, at the request of Roche Irl., prepared a Conceptual Site Model (CSM) for the H2 cell in the last quarter of 2006. This CSM contains remediation proposals for the H2 site. Following further work in 2007, a detailed remediation plan was drawn up. This plan was presented to the EPA in early 2008. From discussions with the EPA it was decided to cap the landfilled area. A project was approved in late 2008. Work has begun on this and the capping is expected to be complete in September 09. 16.1 Landfill Leachate Data for 2008

Licence requirement: Condition 5.4 places a requirement on Roche to ensure that the leachate generated in the landfill site does not result in environmental pollution as a result of controlled or uncontrolled migration. Leachate effluent in the sumps around the landfill area and locations in the boundary drain were monitored for TOC and pH.

Table 27: Landfill leachate analytical data for 2008

March ‘08 August ‘08

Samples pH TOC mg/L pH TOC mg/L

Cell 2 7.14 21.71 6.86 19.02

Cell 3 6.93 215.66 7.22 354.47

Cell 4 7.05 217.0 7.57 9.58

Cell 5 7.51 21.71 7.74 12.28

Cell 6 7.07 189.29 7.42 9.58

Cell 7 7.06 84.21 7.74 6.20

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Table 28: Boundary drain analytical data for 2008

March ‘08 August ‘08

Samples pH TOC mg/L pH TOC mg/L

Boundary drain

opposite D2

7.37 4.73 6.93 8.90

Boundary drain

opposite F2

7.7 12.54 6.92 2.81

17. Landfill Monitoring Report

Licence Requirement: Condition 3.16 specifies the conditions under which the on-site landfill should operate. This includes requirements for control of landfill gas and leachate levels. Condition 11.1.3 requires reporting of any instances where the methane exceeds 1% and / or the CO2 exceeds 1.5% at any point external to the non-hazardous landfill. Due to the extensive work carried out on the landfill (landfill capping) gas monitoring was carried out once in 2007.

Table 29: Landfill Gas monitoring for 2008

Sample point 04/04/08

Oxygen % Methane % CO2 %

Sump Cell 2A 20.5 0 < 1

2B 20.6 0 < 1

2C 20.5 0 < 1

3A 20.7 0 < 1

3B 20.7 0 < 1

3C 20.7 0 < 1

4A 20.8 0 < 1

4B 20.8 0 < 1

4C 20.8 0 < 1

5 20.9 0 < 1

6 20.9 0 < 1

7 20.9 0 < 1

Borehole D2 21.0 0 < 1

Borehole G2 20.9 0 < 1

Borehole H2 20.8 0 < 1

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Sump Cell 2A 20.8 0 < 1

2B 20.7 0 < 1

2C 20.8 0 < 1

3A 20.8 0 < 1

3B 20.8 0 < 1

3C 20.8 0 < 1

4A 21.0 0 < 1

4B 20.9 0 < 1

4C 20.9 0 < 1

5 20.8 0 < 1

6 20.8 0 < 1

7 20.8 0 < 1






Sump Cell 2A 20.9 0 < 1

2B 20.9 0 < 1

2C 20.9 0 < 1

3A 20.9 0 < 1

3B 20.9 0 < 1

3C 21.0 0 < 1

4A 21.0 0 < 1

4B 20.9 0 < 1

4C 20.9 0 < 1

5 20.9 0 < 1

6 20.9 0 < 1

7 20.9 0 < 1

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Borehole F2 20.8 0 -





Sump Cell 2A 20.9 0 < 1

2B 20.9 0 < 1

2C 21.0 0 < 1

3A 20.8 0 < 1

3B 20.9 0 < 1

3C 20.9 0 < 1

4A 20.9 0 < 1

4B 21.0 0 < 1

4C 20.9 0 < 1

5 20.9 0 < 1

6 20.9 0 < 1

7 21.0 0 < 1


Borehole F2 20.9 0 -



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18. Resource Usage and Reduction Report

18.1 Efficiency of raw material usage in production A review of raw material efficiency in 2008 is contained in Section 10.2 EMP Review 2008. The goals around the efficient use of resources and materials for 2009 are contained in the EMP for 2009, section 10.3.

18.2 Water demand and discharge minimisation

Water is used extensively in the manufacturing process to provide either heating or cooling of the production process. The site also uses water for domestic purposes. In 2008 the overall water withdrawal from the public supply decreased from 190,525 m³ in 2007 to 178,180 m³. Ref. Table 16.

19. Environmental Liabilities Risk Assessment Review

19.1 Introduction In May 2006, Roche updated their Integrated Pollution Control Licence (IPC Licence) to an Integrated Pollution Prevention and Control Licence (IPPC), Register Number: P0012-04. This was undertaken in order to meet the requirements of the European Incineration of Waste Directive 2000/76/EC and the IPPC directive (96/61/EC) which was transposed into Irish Law in 2003 with the enactment of the Protection of the Environment Act (PoE) 2003. 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.

Licence requirements: Condition 12.2 of licence P0012-04 specifically makes reference to these requirements. These specific conditions are quoted below:

Condition 12.2 Environmental Liabilities 12.2.2 ‘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/CRAMP……’

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12.3.2 ‘As part of the measures identified in Condition 12.2.1, the licensee shall, to the satisfaction for the Agency, make financial provision to cover any liabilities identified in Condition 12.2.2….’

In order to meet the requirements of condition 12 of the facility’s IPPC licence outlined in Section 1, RPS Group were contracted by Roche Ireland Limited to carry out an Environmental Liabilities Risk Assessment (ELRA) of the facility. The ELRA was submitted and approved by the EPA. The licence states that ELRA should be reviewed as necessary to reflect any significant change on site, and in any case every three years following the initial agreement. No significant change occurred on site during 2008 which would necessitate a change to the ELRA. The ELRA will be reviewed in 2009 as per the schedule.

19.2 Programme to achieve closure

The production processes at Roche Ireland 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 shall be decommissioned and decontaminated. Figure 4 summarises the likely methodology employed in fully decommissioning and decontaminating the entire facility. Decontamination of production equipment is included as part of these controls and is part of regular practice in the plant and therefore would not incur significant additional costs, resources or time to undertake at time of closure. Ground investigations, soil and groundwater testing programmes have been undertaken at the Roche facility over a number of decades. These investigations have focused on the landfill area, the area under the production building and the vicinity of the WWTP. As identified in the Closure Plan, contamination may exist in certain areas of the production facility as well as in the landfill. It is therefore proposed to deal with the Restoration and Aftercare of the facility in two sections:

• RAMP for the production area, utilities and wastewater treatment plant

• RAMP for the Landfill

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Figure 1: Flow Diagram of Likely Order of Full Site Closure

Decommission Production Buildings

Empty Warehouses and Decontaminate buildings and

drains

Empty Tank Farm and Fuel Tanks

Shutdown and Decommission Liquid Vapour Incinerator

Shutdown and Decommission Boilers

Shutdown & Decommission Cooling Towers and Chillers

Decommission Nitrogen Plant

Decommission Compressed Air

Shutdown and Decommission Water Purification Unit

Decommission Laboratories

Clear Contractors Compound

Ship raw materials to suppliers/sister plants

Cleaning procedure as per SOP

Remove coolant water for incineration and collect

refrigerants

Clean Waste Management Area

Step 1

Step 2

Step 3

Step 4

Step 5

Step 6

Step 7

Step 8

Step 10

Step 9

Step 11

Step 12

Remove waste chemicals to Waste Management Area

Decommission WWTP Remove Waste Sludge for disposal. Remove excess Reagents

Step 13

Liquidate production equipment, resale or scrap

Liquidate LVI equipment, resale or scrap

Offer for resale or scrap

Offer units for resale or scrap

Offer unit for resale or scrap

As part of Restoration, Aftercare Plan

Offer units for resale or scrap

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Annex 1: Monthly Data for Final Effluent Discharge to Fergus Estuary

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Annex 2: Emissions to atmosphere from incinerator and notification review Table 5 contains a summary of the measured emissions to atmosphere from the liquid/ vapour incinerator for 2008. All licenced parameters were well within the emission limit values required by the licence. Reported Incidents

• In January the Incinerator stack analyser spectrometer failed and was sent for repair. The new FTIR analyser which had been installed on the stack in 2008 as backup for the main analyser was commissioned and from this date, this analyser was used as the primary instrument for stack emission analysis.

• Between 22nd July and 16th August a total of 39 30-min segments were reported as ‘Failure for the HCl Neo Laser analyser. This was due to an airline fault on the stack which has been rectified.

• On 14th, 15th August and 18th August, a total of 70 30-min segments were reported as ‘Maintenance’ for the dust analyzer. This was due to a defective shutter motor and repositioning of the flywheel. (Incident Report #1929)

• On 23rd November, 1 30-min segment and on 24th November 6 30-min segments were reported as ‘Failure’ for the HCl Neo Laser analyser. This was due to low signal transmission strength (<30%) caused by misalignment of the laser. (Incident Report #1966)

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Annex 3 Noise Monitoring Locations

H1 H2

H3

H4

H6

H5

B1 B2

B3

B4

B5 B6

B7

B8

B9

Annex 4 : AER/PRTR 2008

Roche Ireland Limited Annual Environmental Report 2008 · Roche Ireland Limited aims to achieve the...

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