LEO Pharma - epawebapp.epa.ie

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LEO Pharma

ANNUAL ENVIRONMENTAL REPORT 2008

1. INTRODUCTION .............................................................. 2 1.1 SITE DETAILS.............................................................. 2 1.2 ACTIVITIES AT THE SITE............................................... 2 1.3 COMPANY ENVIRONMENT POLICY................................... 2 1.4 RESPONSIBLE CARE ..................................................... 3 1.5 ENVIRONMENTAL MANAGEMENT ORGANISATION ............. 3 1.6 IPPC LICENCE.............................................................. 3

2. SUMMARY INFORMATION ............................................... 4 2.1 MAIN FEATURES OF AER 2008 ....................................... 4 2.2 COMPLIANCE WITH IPPC LICENCE - SUMMARY TABLES ... 6 2.3 LEVELS OF EMISSIONS TO ATMOSPHERE 2008 ................ 9 2.4 LEVELS OF EMISSIONS TO FOUL SEWER 2008 ............... 10 2.5 ENVIRONMENTAL INCIDENTS AND COMPLAINTS - 2008 .. 11 2.6 SUMMARY OF NOTIFICATIONS TO EPA 2008 .................. 12 2.7 AGENCY MONITORING RESULTS .................................. 13

3. ENVIRONMENTAL MANAGEMENT REPORT 2008 ............ 15 3.1 SIGNIFICANT ISSUES IN 2008..................................... 15 3.2 SOLVENT USAGE 2008................................................ 16 3.3 WASTE 2008 ............................................................. 17 3.4 ENERGY USAGE 2008 ................................................. 20 3.5 WATER USAGE 2008................................................... 21 3.6 PROGRESS ON OTHER ENVIRONMENTAL ISSUES IN 2008 22 3.7 ABATEMENT MEASURES – EFFLUENT ............................ 24 3.8 ENVIRONMENTAL TRAINING 2008 ................................ 25 3.9 2008 EPA SITE INSPECTION ........................................ 25

4. ENVIRONMENTAL MANAGEMENT PROGRAMME 2009 .... 28 4.1 KEY FEATURES OF THE EMP......................................... 28 4.2 ENERGY, WATER AND RAW MATERIAL EFFICIENCY ......... 29 4.3 TARGETS AND OBJECTIVES 2009 ................................. 31 4.4 OTHER ENVIRONMENTAL ISSUES................................. 32 4.5 5 YEAR TARGETS ....................................................... 32

5. APPENDICES................................................................. 34

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1. INTRODUCTION

1.1 SITE DETAILS LEO Pharma is the main Irish pharmaceutical manufacturing subsidiary of the LEO Group of Companies which has its headquarters in Denmark and is owned by the LEO Foundation. IPPC Licence Register Number : Reg. No. P0008-01 Licensee : LEO Laboratories Ltd. Location of Site : Cashel Road, Crumlin, Dublin 12. Licence Enforcement Category : B3

1.2 ACTIVITIES AT THE SITE The company’s core business is the manufacture of pharmaceutical topical products for worldwide markets. The ointments, creams and gels produced on this site are used in the treatment of eye infections and dermatological conditions including psoriasis and eczema. Over 62 million tubes of product were manufactured in 2008.

1.3 COMPANY ENVIRONMENT POLICY With regard to the environment, the Company seeks to minimise the impact of its operations on the environment, by means of a programme of continuous improvements. To advance this goal, LEO Pharmaceutical Products Ltd., the parent company formulated an overall Environmental Policy Statement signed into effect by the Group Managing Director in November 1996. The implementation of the Group policy on the Dublin site was affirmed in 2008 when the Managing Director and Operations Director signed the Environment, Health and Safety Policy (ref. EHS 01 01). Within this policy the Company is committed to identifying and reducing environmental impacts resulting from the company operations. A copy of this policy is included in Appendix I.

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1.4 RESPONSIBLE CARE As a member of Pharmachemical Ireland, LEO Pharma strongly supports the initiative developed by the international chemical industry, called Responsible Care, and is fully committed to the set of health, safety and environment Guiding Principles drawn up under Responsible Care by Pharmachemical Ireland.

1.5 ENVIRONMENTAL MANAGEMENT ORGANISATION The Environmental Management Organisation of the Company is set out in the organogram included as part of this report. In 2008 the Company set up a dedicated Environment, Health and Safety management system. Policies and procedures relating to the Environment are being located within this dedicated system.

1.6 IPPC LICENCE This Annual Environmental Report has been prepared in accordance with condition 2.3 of the IPPC licence which requires that such reports be submitted on an annual basis.

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2. SUMMARY INFORMATION

2.1 MAIN FEATURES OF AER 2008

1. An unannounced site inspection of the Company by the EPA took place

on 29/01/08. The Company was found to be in compliance with its licence. There were three observations which did not constitute a breach of the licence. The observations have been addressed and progress is detailed in this report. In its written summary the Agency made the following observation:

“The Agency commends you and the staff of Leo Laboratories Limited on having a compliant audit and notes the efforts being made to ensure such compliance”.

2. The Company compliance with its IPPC licence continues at a very high

level. In 2008 it was 99.80%.

3. Mass emissions to the foul sewer for oils, fats and grease, suspended solids, BOD and COD were the lowest on record. Significant reductions in energy usage, water consumption and waste generation were also recorded.

4. Production at the Company’s Penicillin Plant ceased in December 2007

and demolition began in June 2008. Synthesis work ceased at the Diuretic Synthesis Plant in December 2007 and all remaining work finished in March 2008.

5. The Company received two environmental complaints in 2008. While

not reaching its target of zero complaints, this was still a considerable achievement given the sensitive location of the factory and given that the Penicillin Plant was completely demolished this year.

6. The Company continued the upgrade of its waste facilities in 2008 and

work is ongoing in 2009. The benefits are improved conditions for the handling, separation and disposal of waste.

7. Commissioning of the extension to the Topicals Manufacturing Plant continued in 2008.

8. The Company has set ambitious targets for 2009 and in its 5 year plan.

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ENVIRONMENTAL MANAGEMENT ORGANISATION

SITE ENGINEERING & EHS DEPARTMENT

Project Department

Environment, Health and

Safety Department

Environmental Compliance Manager

Brian O’Neill*

EHS Executives Barry Conheady

Kevin Reid #

Facilities Department

Waste Operatives

Joe Butler Tony Clinton

Site Engineering & EHS Manager

Martin Carmody

* Brian O’Neill retired in August 2008 # An additional EHS executive will be appointed in May 2009

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2.2 COMPLIANCE WITH IPPC LICENCE - SUMMARY TABLES

Monitoring – Compliance Statistics

NO. IN COMPLIANCE % COMPLIANCE

Effluent Monitoring 2633 2627 99.77%

Surface Water Monitoring

72 72 100%

Ground Water Monitoring

12 12 100%

Air Monitoring 220 220 100%

Vault Water Monitoring 4 4 100%

TOTALS 2941 2935 99.80%

COMPLIANCE LEVEL 2004 – 2008 The following table details the level of compliance of LEO Pharma with its IPPC Licence since 2004.

2004 2005 2006 2007 2008

99.92% 99.83% 99.75% 99.97% 99.80%

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LEVEL OF LICENCE COMPLIANCE 2008 Licence compliance is reviewed in the attached tables. Overall compliance for 2008 was 99.80%. The level of compliance for most parameters was 100%. All non-compliances were reported and explained to the Agency at the time they occurred and are documented in the section on notifications to the EPA.

LEVEL OF LICENCE COMPLIANCE – EFFLUENT

PARAMETER

FOUL

DRAIN NO.

NO. OF SAMPLES

LIMIT

NO. WITHIN LIMIT

% COMPLIANCE

Temperature 4 365 35°C 361 98.9%

pH 4 245 6 – 10 243 99.2%

BOD 4 12 2000 ppm 12 100%

COD 4 245 4000 ppm 245 100%

Suspended Solids 4 52 400 ppm 52 100%

MBAS 4 12 100 mg/l 12 100%

Ammonia as N 4 4 50 mg / l 4 100%

Oils/Fats and Grease

4 168 100mg/l 168 100%

MIBK 4 233 10 ppm 233 100%

Methanol 4 233 140 ppm 233 100%

Acetone 4 233 460 ppm 233 100%

Ethanol 4 233 1290 ppm 233 100%

Isopropanol 4 233 1750 ppm 233 100%

Volume to Foul Sewer

4 365 500m³/d 365 100%

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LICENCE COMPLIANCE EFFLUENT 2004 – 2008

YEAR NO. OF SAMPLES NO. OF SAMPLES IN COMPLIANCE

%

2004 3193 3190 99.91%

2005 3182 3176 99.81%

2006 3316 3308 99.76%

2007 3308 3307 99.97%

2008 2633* 2627 99.77%

* Continuous solvent monitoring of effluent stopped in June 2008, and accounts for the reduction in the number of samples. The number of samples will be further reduced in 2009, the first full year after ending this monitoring.

LEVEL OF LICENCE COMPLIANCE 2008 – VARIOUS

LEVEL OF LICENCE COMPLIANCE – SURFACE WATER MONITORING

PARAMETER NO. OF

SAMPLES LIMIT

NO. WITHIN LIMIT

% COMPLIANCE

pH 24 7 – 11 24 100%

TOC 24 100 ppm 24 100%

COD 24 200 ppm 24 100%

LEVEL OF LICENCE COMPLIANCE – GROUND WATER MONITORING

NO. OF SAMPLES NO. WITHIN LIMIT % COMPLIANCE

12 12 100%

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LEVEL OF LICENCE COMPLIANCE – TANK FARM VAULT WATER ANALYSIS

NO. OF SAMPLES NO. WITHIN LIMIT % COMPLIANCE

4 4 100%

Vault water samples were taken and analysed bi-monthly during 2008 until the tank farm was decommissioned and demolished.

LEVEL OF LICENCE COMPLIANCE – AIR MONITORING

PARAMETER NO. OF

SAMPLES LIMIT

NO. WITHIN LIMIT

% COMPLIANCE

Penicillin 220 60 mcg/m3 220 100%

The Penicillin and Diuretic Synthesis Plants closed in 2007. As the scheduled air emission monitoring points were associated with these plants, no air monitoring for ammonia, VOC’s or particulates was carried out in 2008. Monitoring for penicillin was carried out during the demolition of the Penicillin Plant as agreed with the Agency.

2.3 LEVELS OF EMISSIONS TO ATMOSPHERE 2008 Following the closure of the Penicillin and Diuretic Plants in 2007, there were no emissions from the licensed emission points in these plants in 2008. The production processes in the remaining General Pharmaceutical Plant involve only the blending and mixing of materials and no solvents are used in these processes. The remaining licensed air emission points are associated with the laboratory fume-hoods and the boiler stacks. The laboratory points are classified as minor emission points and are not significant sources of VOC’s or particulates. The boilers are run exclusively on natural gas.

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2.4 LEVELS OF EMISSIONS TO FOUL SEWER 2008

The following summary table sets out the various emission amounts sent to the foul sewer in 2008 together with licensed limit values.

Parameter Mass

Emissions 2008

Licensed Mass Emissions

Mass Emissions 2008 % Allowed Load

Volume m3 38,998 182,500 21.37%

Oils, Fats and Grease kg

1,038 18,250 5.69%

Suspended Solids kg 3,050 73000 4.18%

COD kg 11,579 730,000 1.59%

BOD kg 4,192 365,000 1.15%

Ammonia kg * 0 9,125 0.00%

Detergents (As MBAS) kg

17 18,250 0.10%

Methyl-isobutyl-ketone kg *

7 1,825 0.38%

Methanol kg * 119 25,550 0.47%

Acetone kg * 76 83,950 0.09%

Ethanol kg * 31 235,425 0.01%

Isopropanol kg * 22 319,375 0.01%

*As these materials are no longer in use on the site, monitoring for them ended in 2008 and emission figures will not be reported in future AER’s.

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2.5 ENVIRONMENTAL INCIDENTS AND COMPLAINTS - 2008 1. Environmental Incidents In 2008 LEO Pharma had 7 exceedences of its IPPC licence. The Agency was notified on each occasion in the agreed manner as specified in the IPPC licence. Copies of the licence exceedences and the remedial action arising from them are kept and are available for inspection in the Company’s EPA notifications file and are recorded in Section 2.6 below. 2. Complaints In accordance with condition 11.3, the Company is required to record and notify the Agency of any complaints received on a monthly basis. In 2008, two valid environmental complaints were made.

Date

Nature of complaint

Cause

Corrective

Action

Date of

Notification to EPA

12/07/08 Unusual noise coming intermittently from premises

There was a broken connection on the air exhaust of the nitrogen generator

The connection was repaired. In future the connection will be replaced regularly as part of the preventative maintenance on this system.

10.08.08

27/10/08 Demolition noise coming from LEO Pharma site on a public holiday

The demolition contractors were based in the UK and did not observe the Irish public holiday, but worked as normal

Work was halted when the complaint was received. The contractor was informed that they would not be allowed to work on Irish public holidays in future

04.11.08

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2.6 SUMMARY OF NOTIFICATIONS TO EPA 2008

Date Non-

Compliance

Level of Non-

Compliance Cause

Corrective Action

Date of Notification

to EPA 30/07/08 Temperature

of effluent Temperature of 36 -38oC for 75 minutes Licence limit ≤ 35oC

Discharge of hot water from washing processes during warm weather.

In as far as possible discharges of hot water were delayed to maximise natural cooling

31/07/08

01/08/08 Temperature of effluent

Temperature of 37 - 39oC for 2 hours Licence limit ≤ 35oC



05/08/08


Temperature of 36oC for 75 minutes Licence limit ≤ 35oC



22/08/08

24-25/08/08

pH of effluent

pH of 11.9 for 75 minutes and pH of 11.6 for 75 minutes

The dosing system malfunctioned when the cable to the pH probe became loose and severed

The exceedence was corrected when a new pH cable and probe were fitted

25/08/08


Temperature of 36 - 37oC for 90 minutes Licence limit ≤ 35oC


Usage of hot water on site was reviewed with a view to reducing discharges

27/08/08

30-31/10/08

pH of effluent

pH of 10.0 – 10.64 intermittently over 7.5 hours

The pH probe in the neutralisation chamber failed

The exceedence was corrected when a new pH cable and probe were fitted

04/11/08

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SUMMARY OF NOTIFICATIONS TO EPA 2008

Date Non-

Compliance

Level of Non-

Compliance Cause

Corrective Action

Date of Notification

to EPA 12 -13/11/08

pH of effluent

pH of 10.08 – 10.64 intermittently over 20 hours

Alkaline effluent was discharged to the neutralisation chamber as a result of demolition works occurring on the site. This effect was not anticipated and the on-hand stock of acid was exhausted

The exceedence was corrected when additional acid stocks were delivered and dosed to the neutralisation chamber

13/11/08

2.7 AGENCY MONITORING RESULTS

Effluent Emissions – Agency Monitoring Results in 2008

In 2008, EPA personnel visited the site on 1 occasion and Dublin City Council personnel on 11 occasions. On each occasion a sample of effluent was taken for analysis, with LEO Pharma taking a parallel sample. A total of 48 tests were carried out at LEO Pharma on the parallel samples. The EPA results for the analysis carried out on the sample collected on 12/06/08 are tabulated below.

Parameter IPC Licence* Limits 12-06-08

Flow m3/day 500 Nm

Temp. °C 35° Nm

pH 6 – 10 7.2

BOD mg/l O2 3000 3

COD mg/l 02 5000 832

Suspended Solids mg/l 500 182

Oils, Fats and Grease mg/l 150 231#

Ethanol mg/l 1290 < 10

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Parameter IPC Licence* Limits 12-06-08

< 10 Isopropanol mg/l 1750

< 10 Methanol mg/l 140

< 10 Acetone mg/l 460

< 10 MIBK mg/l 10

Ammonia mg/l 75 0.16

* Emission limit values are for grab samples values, Nm = not measured # This result has been reviewed by the Agency and is not regarded as a non-compliance as the balancing tank was not discharging at the time of sampling. .

AIR EMISSIONS – AGENCY MONITORING IN 2008 No air monitoring was carried out on behalf of the Agency in 2008. Licensed air emission points remaining active on the site are limited to the two boiler stacks and the two minor emission points associated with the laboratories.

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3. ENVIRONMENTAL MANAGEMENT REPORT 2008

3.1 SIGNIFICANT ISSUES IN 2008 Many significant changes took place in Environmental Management in 2008. 1. Closure and demolition of the Penicillin Plant The Penicillin Plant closed in December 2007. This plant was a multi-functional integrated production facility. Within this plant, an Active Pharmaceutical Ingredient (API) department synthesised and purified various penicillins from basic starting materials. These were then formulated elsewhere in the plant into different dosage forms including tablets, parenterals and intramammaries. The finished products were then packaged and prepared for shipment. The closure of this plant, along with closure of the Diuretic Synthesis Plant (see below), significantly changed the environmental profile of the LEO Pharma site. The solvent and waste solvent storage facilities of the tank farm were no longer required. Many air emissions points became redundant and the site usage of water and energy dropped considerably, as did the volumes of waste being produced. A number of options for the future use of the building were considered and it was decided that it should be demolished. A demolition plan, including an environmental risk assessment was prepared and submitted to the Agency for approval. Demolition of the plant began in June 2008 and was completed in February 2009. A monitoring programme was in place for the duration of the demolition and it confirmed that there were no environmentally significant emissions to atmosphere, surface water, sewer or noise emissions during the project. A communication programme was in place and our neighbours were informed on a number of occasions on the progress of the works. We received one valid complaint during the project when work was carried out on a public holiday. This is detailed in section 2.5 above. 2. Closure of the Diuretic Synthesis Plant The Diuretic Synthesis Plant produced a drug used in the treatment of high blood pressure. This was made in a multi-stage chemical process and was followed by micronisation, a particle size reduction process. The finished drug was then exported to other Group facilities for tablet production. Synthesis operations ceased in December 2007 and micronisation of remaining stocks finished in March 2008. Two licenced air emission points became redundant when this plant closed and there were savings in water and energy usage and a reduction in waste generation. The plant has been cleaned and all chemicals have been removed from it, leaving it in a safe and secure condition. A formal decommissioning plan will be produced in Quarter 2, 2009.

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3. Total Waste Management Contract The Company entered into a Total Waste Management contract with a major waste contractor in May 2008. The contract included all hazardous, non-hazardous and recyclable waste streams arising on the site. Through the expertise of this contractor, considerable progress has been achieved in the efficient processing, recycling and disposal of the waste arising here. It is hoped that further reductions in overall waste volumes and increases in the quantities being recycled will result in 2009. 4. Extension to Topicals Manufacturing Plant Commissioning of the extension to the Topicals Manufacturing Plant continued in 2008. The new extension is for the manufacture of sterile ophthalmic products. As submitted at the planning permission stage for the building, the new extension will not have any affect on the scope of the IPPC licence i.e. Condition I. 5. Preparation of Environmental Risk Assessments and Environmental Liability Risk Assessment The Environmental Management Programme for 2008 outlined that 15 areas had been identified for risk assessment and these assessments were carried out in 2008. In addition, an Environmental Liability Risk Assessment was carried out in Quarter 4, 2008 with the assistance of an external consultant. A copy of this assessment has been delivered to the Agency. A Closure, Restoration and Aftercare Management Plan has also been prepared and was sumitted to the Agency in Quarter 1, 2009.

3.2 SOLVENT USAGE 2008 In earlier Annual Environmental Reports, solvent usage was reported as a significant parameter, as considerable quantities of solvents were used on site in the Penicillin and Diuretic Synthesis Plants. With the closure of these plants in 2007, solvent usage has almost been eliminated. No solvents are used in the production processes remaining on site, and only small quantities are used for ancillary activities such as analytical testing and sanitising. Stocks of solvent remaining from the plants which had been closed, were disposed in 2008, and the solvent tank-farm was decommissioned and removed. Continuous monitoring of effluent for solvent stopped in June 2008. Daily checks were carried out when the solvent tanks were being removed in October and November and these results have been submitted to the Agency. All results were within licence limits

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3.3 WASTE 2008

PARAMETER 2007 2008

Total quantity of waste (tonnes)

1156 757

Non-recovered waste 828 451

Recovered waste 328 306

WASTE ECO-PRODUCTIVITY INDEX 2008

Parameter 1991 2006 2007 2008

Output (tonnes) 986 2396 2286 2210*

Waste (tonnes) 470 694 828 451

Ratio of Output/Waste 2.10:1 3.5:1 2.8:1 4.90:1

Waste – eco productivity index 100 167 133 233

Waste generated (tonne) per tonne of product shipped

0.477 0.290 0.362 0.204

* The output tonnage used in this and the following sections is based on the total weight of product exported, i.e. product and associated packaging. The total amount of bulk pharmaceutical product made in 2008 was 1347 tonnes. The eco-productivity for waste is based as before on the amount of waste landfilled or incinerated and excludes all waste recovered. The figures for waste for 2008 show a substantial reduction in waste volumes both in real terms and by comparison to product output. It was noted in the 2007 AER that the target eco productivity for waste of 200 was not met, due to a number of exceptional circumstances. However the figures for 2008 indicate that waste performance has recovered since then, surpassing the 2006 as well as the 2007 figures. The closure of the Diuretic Synthesis and Penicillin Plants in 2007 resulted in the disposal of associated redundant chemicals in 2008 and these are reflected in the figures shown above. It is anticipated that further improvements will be reported in next year’s AER when activities on the site are concentrated on the core topicals manufacturing plant. The disposal of waste associated with the demolition of the Penicillin Plant is not included in the figures above. A specialist decommissioning and demolition company was contracted to carry out this project. They dealt with this according to the waste hierarchy, with useful equipment being sold on to other plant operators. Most of the remaining materials were recycled including the reinforcing and structural steel and the concrete and masonry, with only the minimum being sent to landfill. The demolition finished in February 2009 and a full report on the waste management aspects of it will be included in the 2009 AER.

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Recovered Waste 2004 - 2008

YEAR WASTE TONNES

2004 874.12

2005 502.63

2006 426.78

2007 328.01

2008 306.44

RECOVERY, RE-USE, RECYCLING 2008

EWC CODE

WASTE MATERIAL TYPE

QUANTITY (TONNES)

RECOVERY METHOD

1. 200101 Waste Paper/Cardboard 87.81 Recovery/

Recycle

2. 150104 Aluminium 0 n/a

3. 170407 Steel Barrels 2.71 Recovery

4. 150103 Timber 46.96 Recovery

5. 200102 Glass 1.37 Recycle

6. 160213* WEEE 0.74 Recovery

7. 200139 Plastic 5.93 Recovery/

Recycle

8. 160602* Obsolete Batteries 0.073 Recovery

9. 200121* Fluorescent Tubes 0.116 Recovery

10. 200108 Canteen Waste 2.78 Recovery

11. 170107 Rubble 19.06 Recovery

12. 200301 Mixed Recyclable Waste 135.21 Recovery/

Recycle

13. 070504* Waste Solvents 3.68 Recovery

TOTAL 306.44 Tonnes

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LEO Pharma recovers, re-uses and recycles packaging and waste materials, where such facilities exist and where feasible, as already detailed in this section on waste management. In 1999, the Company joined Repak Ltd., an approved scheme under the 1997 Waste Management (Packaging) Regulations to fulfil the Company’s obligations for recycling packaging waste. LEO Pharma fulfils its commitments as a member of Repak Ltd. by providing Repak with half yearly statistical data on packaging waste together with an Annual Waste Management Plan. The Environment Department introduced a scheme of waste segregation at source in 2007 and extended this to all areas of the site in 2008. This system uses colour coded bags for paper/cardboard (blue), mixed recyclable (green), landfill waste (grey) and hazardous waste (red). This system is helping to ensure that waste is prepared and dispatched to its proper disposal location, as well as maximising recovery/ recycling and minimising landfilling of waste. Non-Recovered Waste (tonnes) 2004 - 2008

Description 2004 2005 2006 2007 2008

Dry Waste

(Non recyclable packaging/paper

etc.)

25 83 152 264* 130

Drummed waste (liquids,

ointments, raw materials etc.)

263 205 306 305 213

Liquid Bulk

(Solvents) 196 212 236 259 108

TOTAL (tonnes) 484 500 694 828 451

Ratio waste / product shipped

21.2% 20.6% 28.9% 36.2% 20.4%

*Includes C & D Waste

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In addition to an analysis of recovered and non-recovered waste, the Company also tracks waste by the amounts classified as hazardous and non-hazardous. Non-Hazardous and Hazardous Waste 2008

PARAMETER 2007 2008

Total Quantity of waste (Tonnes) 1156 757

Quantity of Non-Hazardous Waste (Tonnes)

590 432

Quantity of Hazardous Waste (Tonnes)

566 325

3.4 ENERGY USAGE 2008 Gas and Electricity Usage 2008

Parameter 2007 2008 Change

2007 – 2008

Natural Gas (MW.h)

20,643 15,390 -25.45%

Electricity (MW.h) 17,172 11,789 -31.35%

Total Energy (MW.h)

37,815 27,179 -28.13%

Eco-Productivity Index Energy 2008

Parameter 1991 2007 2008

Output (tonnes) 986 2286 2210

Energy Usage (MW.h) 22,100 37,815 27,179

Ratio of output to Energy/100 4.46:1 6.04:1 8.13:1

Energy Eco Productivity Index 100 135 182

Energy Consumption/Tonne of Product

22.4 16.5 12.3

Energy usage reduced substantially in real terms in 2008. This reduction occurred in a year where there was only a slight reduction in overall production output. This resulted in an increase in the Eco Productivity Index, indicating a significant improvement in energy efficiency.

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The two principal reasons were:

1. A number of projects were completed in the last year, and which are contributing to on-going energy savings. These projects are reported in Appendix IV, Capital Projects Report 2008.

2. The Penicillin and Diuretic Plants which closed in 2007 were relatively old facilities, and the processes involved were energy intensive. The improvement in Eco Productivity Index reflects the lower energy requirements and the relative efficiency of the processes and equipment in the remaining topicals manufacturing facility.

3.5 WATER USAGE 2008

Water Usage and Eco-productivity Index 2008

Parameter 1991 2006 2007 2008

Output (tonnes) 986 2396 2286 2210

Water Usage(m3/year) 81,425 74,257 76,816 50,086

Ratio of Output to Water/100 1.21:1 3.23:1 3.0:1 4.41:1

Water Eco Productivity Index 100 270 248 365

Water Consumption/Tonne of

Product 82.6 31.0 33.6 22.7

Water usage is calculated as the total of all metered water supplies to the site. The effluent figures below refer to process related water discharges, the balance being made up of water contained within the product, as well as water used for the canteen, toilets etc.

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Effluent Discharge Figures 2004 – 2008

YEAR ANNUAL EFFLUENT DISCHARGES m3

2004 57,913

2005 56,150

2006 62,414

2007 63,116

2008 38,998

Water usage reduced significantly in real terms in 2008, corresponding with the closure of the Penicillin Plant and Diuretic Synthesis Plant. This reduction in water usage is reflected in both the water taken in the site which reduced by almost 35% and in the reduced discharge of effluent which reduced by over 38%. Water sprays were used to as a dust control measure during the demolition of the Penicillin Plant and accounted for significant usage of water as well as the generation of increased effluent. Surface water drains in the vicinity of the demolition site were also diverted to the process drain for the duration of the project, and this also resulted in increased effluent discharges. Although the demolition project was not completed until the end of February 2009, it is expected that significant further reductions in water and effluent will be achieved in the coming year. The installation of new water meters will identify locations of high usage and will be used to implement a water reduction programme

3.6 PROGRESS ON OTHER ENVIRONMENTAL ISSUES IN 2008

The following is the outcome for goals and objectives set out in the Management Programme section of last year’s Annual Environmental Report. 1. Licence Compliance

Target

Progress Update

To maintain or improve on the level of compliance achieved in 2007.

The Company achieved a high level of compliance, 99.80%, in 2008 although this is slightly below the 99.97% achieved in 2007. A total of 7 licence exceedences were recorded, compared to 2 in 2007.

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2. Complaints

Target

Progress Update

To achieve zero complaints in 2008. In setting this target, the Company realises that this may be difficult given the location of the site.

Two complaints were received in 2008. Although the target was not met, the low level of complaints reflected the considerable efforts undertaken by the Company in this respect, and in particular during the demolition project.

3. Recovery, Re-use and Recycling

Target

Progress Update

To recover, re-use or recycle all non-hazardous waste.

In 2008, 61% of non-hazardous waste was recovered. This was an increase from 55% in 2007.

4. Abatement Control

Target

Progress Update

To maintain the levels achieved in 2001 for oils, fats and grease, suspended solids and COD.

Amount of permitted load emitted to foul sewer Parameter 2008 2001 Oils, Fats, grease (kg)

1,038 3,363

COD (kg) 11,579 41,951 Suspended Solids (kg)

3,050 5,081

The results for oils, fats and grease, suspended solids and COD are better than the target set and the lowest on record.

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5. Environmental Training

Target

Progress Update

The objective of environmental training is to ensure that staff are aware of the conditions of the IPPC licence, to ensure the highest possible level of licence compliance, and to highlight awareness of the procedures for dealing with an environmental emergency. Priority is given to training new staff.

Environmental training is provided on an on-going basis. Records relating to this training are available in the Environment Department. A total of 19 new employees received induction training in 2008. Further details of training are included in section 3.9 below.

3.7 ABATEMENT MEASURES – EFFLUENT LEO Pharma strives to reduce emissions to the foul drain. By the use of better equipment and improved procedures the levels of emissions to this drain continue to fall. The following tables illustrate the record for key parameters since 2004.

2004 2005 2006 2007 2008 Reduction in 2007 – 2008

COD kg 25,482 32,763 26,424 25,606 11,579 54.78%

BOD kg 12,263 14,646 9,570 14,569 4,192 71.22%

Some of the reduction in the last year is related to the closure of two plants and the elimination of the related waste streams. However, an examination of the figures for oils, fats and grease, which are key ingredients in the remaining topical business, illustrate the progress made in reducing emissions to sewer at a time when usage was increased.

2004 2005 2006 2007 2008

Usage of oils, fats and grease (kg)

716,029 812,296 713,626 668,469 735,897

To Drain (kg) 1,776 2,272 2,232 1,878 1,038

% to drain 0.25% 0.28% 0.3% 0.28% 0.14%

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3.8 ENVIRONMENTAL TRAINING 2008

Environmental training was provided on an on-going basis throughout 2008. An introduction to environmental procedures and responsibilities forms part of the induction process for all new employees. A total of 19 new employees received environmental inductions in 2008. An EHS induction is mandatory for all contractors coming to work on the LEO Pharma site. The environmental topics covered include protection of surface water, waste disposal and recycling and the prevention of noise complaints. Over 600 contractors received this induction in 2008. The EHS department held regular briefing sessions during 2008. These sessions were aimed at key personnel in appropriate departments including Engineering, Production and QC. Topics covered in 2008 included the AER and Energy Teams. Training related to waste management and recycling was provided for EHS employees as well as key production personnel and waste contractors.

3.9 2008 EPA SITE INSPECTION As part of the enforcement of the licence an unannounced Site Inspection of the Company took place on 29th January 2008. The site inspection commenced at 09:45 hrs and was conducted by Ms. Maeve O’Reilly, Inspector, Office of Environmental Enforcement. Progress on the Environmental Management Programme was presented to the Inspector. A tour of the site then took place – special attention was paid to waste segregation at site sources, the waste compound, the Penicillin Plant and spill kits. The tour was followed by a review of documentation related to licence conditions. A number of company representatives were interviewed in the course of the inspection. At the closing meeting the findings detailed here were reported. A written report on the outcome of the Site inspection was received dated 7th February 2008. The Company was found to be in compliance with its IPC licence and three observations which did not constitute a breach of the licence were highlighted. Corrective actions arising were attended to and the EPA was notified of the Company’s response by letter dated 27th February 2008.

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The following general comments were made in the EPA’s written report on the Site Inspection. “The licensee’s attitude towards licence compliance was observed to be very positive and well organised during the audit. The penicillin plant closed on 21/12/07 and all relevant emission points from this plant are no longer in use. The plant is currently being cleaned out and the licensee is preparing a decommissioning proposal and residual management plan which is to be submitted to the Agency for approval prior to implementation. Decommissioning of the plant is projected to take six months and there is currently no plan for the future use of the site. The licensee is preparing a communications programme to keep local residents informed about the project.” The Site Inspection findings are detailed in this report together with the corrective actions taken.

SITE INSPECTION 29.01.2008

OBSERVATION

COMPANY RESPONSE 1. Emergency Response Procedure Local Authority or Fisheries Board are not listed as bodies requiring notification where relevant following an incident. Contact numbers for the Agency were out of date. Relevant Category of incident was not included on the Notification Form. Corrective Action Required The licensee shall review the ERP having regard to the Agency Guidance note “Guidance to licensees on the Notification, Management and Communication of Incidents” and update the ERP accordingly.

The emergency response procedure was updated taking into account the Agency Guidance Note. The relevant and updated contact numbers are now included in the procedure. The category of incident is now included on the notification form.

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SITE INSPECTION 29.01.2008

2. Spillage Training A spillage management procedure has been drafted since the last site inspection on 20/10/07. However formal training in this procedure has not been delivered. Corrective Action Required The licensee shall ensure that spillage management training is given to all relevant personnel and that training records are retained for future inspection by authorised persons of the Agency.

The spill kits on site contain standard materials such as cloths, absorbent socks and oil-soak, the use of which is self-evident. Informal training has been given to key members of the emergency response team and directions for use are stored with each kit. The Company will ensure that formal documented training in the use of these materials will be given to all relevant personnel by the end of May 2009.

3. Stockpiling of raw material Mr. Carmody informed the inspector that the facility is stockbuilding White Soft Paraffin (WSP) in tankers on-site for use later in the year. There may be up to nine tankers of WSP stored on-site at a time. This material is solid at planned storage conditions but corresponds to an increase in the raw materials being handled by the facility. Corrective Action Required The licensee is required under Condition 1.2 to inform the Agency in writing of its intention to increase WSP storage on site. A risk assessment on the implications of storing this material on-site for the specified time shall also be included.

The stockpiling of material was confirmed to the Agency by e-mail on 05/02/08, and a copy of the risk assessment was sent to the Agency on 27/02/08.

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4. ENVIRONMENTAL MANAGEMENT PROGRAMME 2009

4.1 KEY FEATURES OF THE EMP The main features of the Environmental Management Programme for 2009 are: 1. Set and implement targets to comply with good management of the

IPPC licence

Included in this Environmental Management Programme are targets set to:

(a) Achieve full compliance with the licence (b) Set a target of having no complaints (c) Recover, re-use and recycle waste streams in as far as possible (d) Maintain low levels for emission of key parameters to the foul sewer (e) Train staff in environment awareness and hold in 2009 an

Environmental Awareness seminar.

2. To progress various capital projects through design and

implementation stages

A listing of proposed capital projects is included in Appendix IV of this report. These projects are seen to have significant environmental benefits and will help to achieve the targets set in this AER. Permission to proceed with these projects is currently awaiting approval from Group Headquarters.

3. To review certain areas of the licence where non-compliances have

occurred

The licence non-compliances which occurred in 2008 centred around the neutralisation chamber and the discharge of effluent which exceeded the licence limits. A full review of all aspects of the operation of this area will be held in Quarter 2, 2009 to ensure that a dependable and robust system is in place with the target of zero non-compliances in 2009.

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4.2 ENERGY, WATER AND RAW MATERIAL EFFICIENCY Energy Efficiency 2009 As a condition of the IPPC Licence the company conducted an audit in 2007 of the energy efficiency of the site identifying opportunities for energy use reduction and efficiency. The audit was carried out in accordance with the Agency’s guidance note for energy efficiencies. The recommendations of the audit were reported in the last AER. In 2008 a number of these recommendations were brought to completion including the replacement of the HVAC chiller and the upgrade of the process chiller. Details of these projects are included in the Capital Projects Report 2008, Appendix IV. The Capital Projects Programme 2009, see Appendix IV, includes details of projects to be undertaken in 2009. Included in this are proposals to further the design process of providing a Combined Heat and Power plant on this site. This plant has the potential to produce substantial energy savings as a source on both hot water and locally generated electricity. The generation of electricity on-site has the potential to significantly reduce our overall carbon footprint, as the substantial energy losses associated with electricity transmission are not incurred. It is likely that the water reduction programme (see below) will result in savings not only in water usage but also in the energy used to heat this water. Reduction in Water Usage 2009 In 2009, the Company will seek to identify the areas of highest water usage and then identify opportunities to reduce consumption including recycling and reuse initiatives. Primary water lines are already fitted with meters. Meters have been installed on end-user supply lines. The Building Management System (BMS) will be upgraded in Quarter 1, 2009 to enable trending and analysis of water usage data from the new and existing systems. It is planned that this initiative will be set up and operational by Quarter 2, 2009.

The date obtained will be reviewed in Quarter 3, 2009 and a further programme of water reduction will be incorporated in the Annual Environmental Programme for 2010. A report on the operation of Clean in Place (CIP) systems was produced by FDT Consultant Engineers in 2008. This report investigated the wash cycles employed and the different washing facilities available. The recommendations of this report are currently under review. It is hoped that this work will bring about savings both in water and energy consumption.

The Company has set a target for annual effluent discharges to fall below 35,000 m3 in 2009 and is confident that this target will be reached.

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Reduction in Waste Generated and the Efficient Use of Raw Materials

Efficient use of Raw Materials Subject to the constraints of Good Manufacturing Practice, the Company will continue to investigate the efficient use of raw materials and energy through process optimisation, increases in batch sizes, bulk purchasing of raw materials and manufacturing of products in multiple batch campaigns. The Company set up an Operational Excellence department in 2008. This group is tasked with improving operational efficiencies across the site. Although at the early stages of analysis of production methods and facilities, the group has the potential to improve environmental performance by reducing processing times and production related losses. To achieve savings in office paper usage, all printers/ copiers with a duplex feature are set to this by default. Documents are then printed on both sides of the paper sheet unless specifically requested by the user. Only printers with this duplex feature will be purchased in future.

New Waste Compound In 2009 the Company is continuing the project started in 2007 to expand and upgrade the Waste Compound. A drum compactor has been purchased for bagged hazardous waste. The bags are packed into drums prior to dispatch off-site. By compacting the drum contents, the weight per drum is much increased, reducing the number of drums used and also reducing the number of collections required. The former drum storage area will be upgraded and made available as an extension of the waste compound. Total Waste Management Contract The Company will continue to work with our Total Waste Management Contractor to identify waste streams that are not currently recovered, with a view to reducing the proportion of waste that is currently landfilled.

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4.3 TARGETS AND OBJECTIVES 2009 The Company has set the following targets and objectives for 2009:

Target Method to Achieve Responsibility

To maintain or improve on the level of compliance achieved in 2008

Continued attention to detail and systematic investigation of all non-compliances

The EHS Manager and staff, the Managers of all relevant Departments

To achieve zero valid complaints

Consideration of external environmental impacts when permitting works and improved awareness among LEO personnel and contractors

The EHS Manager and staff working with Project Engineers and Contract Supervisors

To recover and recycle at least 65% of the non-hazardous waste generated on site and to reduce the landfilled waste to 35%

Improve on the achievements of 2008

The EHS Manager and staff working with the Production Department Managers and the Total Waste Contractor

To maintain or improve the levels achieved in 2008 for COD, BOD, Oils Fats and Grease and Suspended Solids

Review results two monthly and calculate loads emitted. Investigate if levels do not meet targets set.

The EHS Manager and staff working with the Production Department Managers

The EHS Manager and staff working with the Technical Services Department

To achieve overall energy savings on 5% compared to 2008

Progress various energy projects and review on-going energy usage

To conduct induction training with all new staff and to reinforce environmental awareness among existing personnel

Train key personnel whose duties relate to the environment. Conduct an environmental awareness seminar in 2009

The EHS Manager and staff.

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4.4 OTHER ENVIRONMENTAL ISSUES Pollutions Emission Register (PER) Under condition 2.2 of the Company’s IPPC licence it is required to prepare a Pollution Emissions Register. The purpose of the Register is to ensure that the route of disposal or loss of certain substances is tracked, including discharges to air, water, inceration off-site, recovery and recycling and loss in product. Following the closure of the Penicillin and Diuretic Synthesis Plant, and the elimination of solvent usage in production activity, the only remaining relevant activity on-site is the operation of the gas-fired boilers. The generation of combustion gases is detailed in the releases to air section of the eAER which forms part of this report.

4.5 5 YEAR TARGETS The Penicillin and Diuretic Synthesis Plants were decommissioned in 2008, following their closure in 2007. It is the Company’s intention to regard 2009 as the first full year in which its activities have been solely focussed on its on-going business, the manufacture of Topical Products. The current year, 2009, will be taken in future as the new base-line year for the setting of eco-productivity indices. The Company is setting itself a 5-year target of achieving 5% reductions each year for the key parameters of water and waste, as well as improvements in recycling rates and a 35% reduction in carbon dioxide emissions. The Company acknowledges that these ambitious targets may be impacted over the period by changes in market conditions, new products and changing technology, but remains confident that they can be achieved.

5 YEAR TARGETS 2009 - 2013

LICENCE OBJECTIVES COMPANY TARGETS

To reduce the total waste generated in operational activities by 5% each year

Waste Reduction

To increase to 75% the quantity of non-hazardous waste that is recovered, re-

used and recycled

Recovery, re-use and recycling of materials

Water consumption To reduce effluent discharges by 5% each

year

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5 YEAR TARGETS 2009 - 2013

LICENCE OBJECTIVES COMPANY TARGETS

To reduce the total carbon dioxide emissions associated with energy usage on

site (i.e. natural gas and electricity combined) by 35% compared to 2008

Energy

To maintain the mass emissions of these parameters at 2008 levels. This does not

preclude further improvement.

COD, Oils, Fats and Grease, and Suspended Solids

To strive towards the Company goal of 100% compliance with all IPPC licenced

parameters Licence Compliance

Ensure that training continues to be made available to all new employees and to

existing employees whose duties relate to any aspect of the IPPC licence

Training

Complaints To achieve a target of nil valid complaints.

This is a difficult but important target, given our urban location.

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5. APPENDICES

LEO PHARMA

ANNUAL ENVIRONMENTAL REPORT 2008

Appendix I: Environment, Health and Safety Policy, EHS 01 01 Appendix II: eAER, Data Tables 2008 Appendix III: Noise Survey Report 2008 and Noise Survey

Programme 2009 Appendix IV: Capital Projects Report 2008 and Capital Projects

Programme 2009 Appendix V: Annual Groundwater Monitoring Report 2008 and

Monitoring Programme 2009

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Appendix I

Title:

ENVIRONMENT, HEALTH AND SAFETY

POLICY (EHS 01 01)

research based, people driven

LEO Pharma

ENVIRONMENT, HEALTH AND SAFETY (EHS) POLICY As a leading producer of topical pharmaceutical products, LEO Pharma provides a safe and healthy working environment for employees, contractors and visitors. We also work to protect our neighbours and the natural environment from adverse situations arising from our operations or actions. We comply with legal, regulatory and licensed requirements by implementing best practice, industrially recognised systems and other sources of guidance and codes of practise. Environment, Health and Safety (EHS) issues are prioritised here at LEO Pharma. We strive to develop a proactive, continuous improvement ethos in which good EHS practice is integrated into the company’s management programmes and working culture. We will:

• Identify hazards arising from our operations and put appropriate control measures in place to eliminate or reduce the risks and consequences relating to them.

• Actively embrace best practise techniques to identify and reduce environmental impacts resulting from our operations (for example waste, energy, emissions and pollution control).

• Invest in the elimination of known EHS hazards in a phased, prioritised and cost effective manner. • Assign specific EHS duties to LEO Pharma employees, contractors and visitors and ensure that

these duties are fulfilled to the highest standards. • Ensure that adequate resources are always available to implement this policy - including the

continued provision of a dedicated, competent EHS department and occupational health service. • Ensure that practical and effective procedures are implemented and regularly tested to prevent

the occurrence/ control the effects of emergency situations. • Actively encourage communication and the involvement of employees on EHS matters. • Train employees so that they are competent to conduct their work safely and ensure that

awareness of EHS matters always remains a high priority. • Encourage employees and contractors to report unsafe situations so that serious incidents can be

avoided through preventative action. • Investigate all adverse incidents and accidents and ensure that effective corrective actions are not

only put in place, but closed out to prevent re-occurrence. • Audit and monitor operations to ensure compliance with EHS procedures, policies and best

practice. • Ensure that visitors and contractors are aware of, and comply with, LEO Pharma EHS policies and

procedures. Managers and supervisors will be held accountable for non compliance (to EHS policy) of personnel or operations under their direct control. Employees and contractors must observe their legal responsibilities to work safely and to protect themselves, their colleagues and the environment. They must comply with all site and local area EHS rules which have been set down to preserve health, safety and the environment. Failure to follow an EHS policy, procedure or rule may result in referral to the company’s disciplinary procedures. We warmly welcome visitors. Nevertheless, we require that they comply fully with LEO Pharma EHS rules. All employees, contractors and visitors must co-operate with LEO Pharma on matters relating to EHS. All accidents, near misses and unsafe situations must be reported immediately.

Date 01/05/08 Revision Draft 02

Operations Director

Appendix II

Title:

eAER SUMMARY DATA

Appendix III

Title:

NOISE SURVEY REPORT 2008

AND

NOISE SURVEY PROGRAMME 2009

IPPC Licence Condition 8.2

NOISE SURVEY REPORT 2008

Introduction A proposal for the annual noise survey was included in the AER submitted to the Agency in March 2008. This survey was carried out on 20th October 2008 and the report is included in this appendix. It was concluded in the report that “operations at the LEO Pharma site are in compliance with the limits and schedules set out in the company’s IPC licence”.

NOISE SURVEY PROGRAMME 2009

It is proposed that the noise survey carried out in 2008 will be repeated in 2009.

Appendix IV

Title:

CAPITAL PROJECTS REPORT 2008

AND

CAPITAL PROJECTS PROGRAMME 2009

Appendix IV

Capital Projects Report 2008

Many projects were undertaken in 2008. The environmental benefits of some of these projects are outlined in this appendix. 1. HVAC Chiller

The HVAC chilller was replaced in 2008. This has resulted in on-going energy savings of 130 kW.

2. Modifications to the Process Chiller

Modifications to the process chiller have resulted in on-going savings of 70 kW.

3. New Inverters on the Main Air Handling Units

The provision of new inverters on the main air handling units (AHU) has resulted in on-going energy savings of 32 kW.

4. Improvements to waste handling facilities

A new waste compactor has been installed at the tube unloading area. This facilitates the separation and baling of plastic waste arising in this department. Additional racking was provided in the waste compound, allowing improved segregation of waste. A compactor was purchased for the waste compound, to compress bagged hazardous waste, increasing the load held in each drum. This will reduce the number of drums required and also result in less collections of waste. This was brought into operation in January 2009.

5. Upgrade of QC solvent store and gas compound

This project was completed in 2008. The modernised facilities provide more secure storage and containment for laboratory chemicals and compressed gas cylinders.

Appendix IV

CAPITAL PROJECTS PROGRAMME 2009

EHS Projects Programme 2009

All capital projects are reviewed by the Environmental Department at approval stage to ensure that environmental considerations have been taken into account and that they are consistent with the 5 year plan targets. The projects listed below have been proposed for implementation or progression in 2009. The various projects have been submitted to Group headquarters in Denmark and are currently awaiting approval. They are included in this report because they are seen to have particular environmental benefits. 1. Laboratory Upgrade It is planned to upgrade the analytical laboratory this year. Benefits associated with this project include provision of motion detection lighting, improved energy efficiency through modernised heating systems, use of variable speed drive fans and improved control of extract systems. 2. Combined Heat and Power A feasibility study into the provision of a combined heat and power plant was completed in late 2008. This study reviewed electricity and heating needs on the site and identified that a ‘trigen’ CHP plant was a viable alternative to the use of externally generated electricity and separate water heating by gas. The Company intends to proceed with detailed project design in 2009. 3. Replacement of Manufacturing Plant Design work is continuing for the replacement of an existing topicals manufacturing plant. The plant being replaced was installed in the 1980’s and its replacement offers opportunities for improved energy and materials efficiencies. 4. Upgrade of Yard Drains It is planned to upgrade the yard drains in the vicinity of the demolished Penicillin Plant. When this plant was operational, some of the yard drains, along with rain-water flows from some roof areas were piped to the neutralisation chamber and discharged as effluent to the foul sewer. After this upgrade, surface water arising in the area will instead be discharged to Surface Water Drain A, reducing the loading to the foul sewer especially during heavy rain.

Appendix V

Title:

ANNUAL GROUNDWATER MONITORING REPORT 2008

GROUNDWATER MONITORING PROGRAMME 2009

IPPC Licence - Schedule 6(i)

Groundwater monitoring report 2008 Introduction Groundwater samples were taken for analysis from each of the monitoring wells each quarter, as set out in the Groundwater Monitoring Programme 2008. All samples were analysed for Total Organic Carbon (TOC). Analytical Results All results in ppm TOC Warning limit : 50 ppm TOC

Location Quarter 1 Quarter 2 Quarter 3 Quarter 4

Monitoring Well 1 30.24 25.04 29.89 15.23

Monitoring Well 2 33.71 17.90 41.30 0.74

Monitoring Well 3 29.93 22.24 25.10 4.28

Well Locations Monitoring Well 1: Adjacent to Diuretic Synthesis Plant Monitoring Well 2: Adjacent to Main Entrance (Background monitoring well) Monitoring Well 3: Adjacent to Neutralisation Chamber These analytical results were also submitted to the Agency each quarter. The results indicate that no contamination of groundwater has taken place during the monitoring period.

Groundwater monitoring programme 2009 The quarterly monitoring programme carried out in 2008 will be repeated in 2009. A warning limit of 50 ppm TOC will continue to be used. In the event of any sample exceeding the 50 ppm limit, the well will be re-sampled and the sample will be analysed by Gas Chromatography - Mass Spectroscopy to determine the exact nature of the organic material present.