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Covidien Pharmaceuticals Dublin AER 2010

Page 1 of 17

Table of Contents

1. Introduction 3

2. Company Background 3

3. Summary Information 6

3.1 Self Monitoring Data 63.1.1 Emissions to Atmosphere 63.1.2 Emission to Sewer 63.1.3 Emissions to Surface Water 73.1.4 Waste 83.1.5 Resource Consumption 8

4. Environmental Incidents and Complaints 9

4.1 Incidents 9

4.2 Complaints 10

5. Management of the Activity 11

5.1 Covidien Pharmaceuticals Dublin Environmental Management System 11

5.2 Environmental Management Programme Report and Proposal 11

5.3 Pollution Emission Register Report and Proposal 11

5.4 Other Significant Environmental Activities 125.4.1 EPA Inspections and Sampling 12 5.4.2 Environmental Management System Accreditation 12 5.4.3 Energy Initiatives 12

6. License Specific Reports 13

6.1 Noise Monitoring Report 13

6.2 Groundwater Monitoring Report 13

6.3 Bund and Sump Integrity Reports 13

6.4 Tank and Pipeline Inspection Report 15

6.5 Report on List I and II Substance Reductions 15

6.6 Review of Closure, Restoration and Aftercare Management Plan 15

6.7 Review of Environmental Liabilities Risk Assessment 15

6.8 Energy Efficiency Audit 16

7. Conclusions 17


Page 2 of 17

List of Appendices

Appendix 1 Electronic Environmental Data Submission

Appendix 2 IPPC Emissions Summary

Appendix 3 Proposed Environmental Management Programme 2011-2015

Appendix 4 Environmental Management Programme Report 2010

Appendix 5 Pollution Emission Register Report 2010

Appendix 6 Groundwater Monitoring Report 2010

Appendix 7 Bund and Sump Report 2010

Appendix 8 CRAMP- April 2007

Appendix 9 Summary of Environmental Liability Risk Assessment

Appendix 10 Noise Report 2010


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1.

This is the Annual Environmental Report of Mallinckrodt Medical Imaging Ireland (trading as Covidien Pharmaceuticals Dublin) as per Condition 2.9.2 of the Integrated Pollution Control Licence No. P0050-02.

INTRODUCTION

This Annual Environmental Report 2010 has been prepared using the guidelines from the Environmental Protection Agency’s publication “Integrated Pollution Control Licensing, Guidance note for Annual Environmental Report”, published in October 2000.

As specified in the EPA AER guidance document all summary information is presented for the previous calendar year 2010, unless otherwise specified.

A submission of summary information in electronic format will be made to the EPA, as requested in the guidance document. This can be found located in Appendix 1.

2. COMPANY BACKGROUND

Mallinckrodt Medical Imaging Ireland, trading as Covidien Pharmaceuticals Dublin, is located in Damastown Industrial Estate, Mulhuddart, Dublin 15. The plant is a continuous manufacturing pharmaceutical facility which produces Ioversol, a bulk API for Optiray, an X-ray Contrast imaging Agent.

Production began at the site in 1993 after a 16 month construction project. The plant was built on a green-field site. The original development was subject to a capacity expansion project 5 years later in 1998 converting the chemical processing to a new ‘Alternative Synthesis’ process. The site was further expanded in 2008 increasing production of Ioversol by 30%.

There are 104 employees across management, production, engineering, quality, finance and administration with production operating on a four shift rota 24 hours/day for approximately 355 days per year.

In July 2007, Tyco Healthcare split from Tyco International evolving to the new corporation Covidien. With this, the site is now formally trading as Covidien Pharmaceuticals Dublin as reported formally to the EPA in January 2010. Our current Legal entity remains as Mallinckrodt Medical Imaging – Ireland.


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The site covers a total area of 120,000m2, 60,000m2

• Security

of which has been developed by the company. The remaining land is reserved. The developed area contains:

• Boiler room; • Administration (with canteen); • Cooling Tower; • Fire Water Retention Pond; • Tank Farm; • Laboratories • Waste Water Treatment Plant; • Warehouse; • Water Storage; • Process Building; • Drum Store; • Maintenance Building; • Carparks.

The site has been licensed by the Environmental Protection Agency (EPA) since 1995, and is accredited to ISO14001:2004 Environmental Management System Standard since 2006. The scope of this management system is the manufacture and testing of Ioversol, analytical testing of Optiray and related services.

The site Environmental, Health and Safety policy can be found overleaf. It was updated in August 2010 and communicated to all staff operating from the site. It is also posted around the site.


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Page 6 of 17

3.

3.1

SUMMARY INFORMATION

3.1.1 Emissions to Atmosphere

Self Monitoring Data

All emissions to air were within the terms of the license. The boilers operated without visible smoke emissions.

In 2010, studies were being undertaken in the replacement of the site abator for energy reduction and upgrade purposes. This was reported to the EPA in July 2010.

There were no non-compliances relating to air emissions from the site in 2010. A summary table of the air emissions is included in Appendix 1 and has been submitted in electronic form to the Agency.

The full list of parameters of our license as they relate to air monitoring water from the discharge points are included below and in Appendix 2.

Emission Point Parameter IPPC Mass ELV (kg/yr)

Mass Emission 2009 (kgs)

Mass Emission 2010 (kgs)

AB-02 & AB-06 Total Dust (kg/yr) 6622 216.3935 178.86

ABAS-02 TA Luft Organics Class 1 876 19.704 26.304

ABAS-02 TA Luft Organics Class 2 17520 17.472 11.945

AB-03 TA Luft Class 3 Vapour Inorganics 2628 8.736 8.736

ABAS-01 TA Luft Class 3 Carcinogens 219 8.736 15.24

AB-04 & AB-05 NOx 19272 17392.851 13504

AB-04 & AB-05 CO 9636 134.403 135

3.1.2 Emission to Sewer

The summary information required for this AER has been submitted electronically to the Agency. A copy of this submission is included in Appendix 1. The full list of parameters of our license as they relate to monitoring of waste water from the discharge point to sewer is included below and in Appendix 2.

There were no non-compliances relating to emissions to sewer in 2010. All parameters were within IPPC limits. Significant efforts were made to reduce the volume of low strength waste water flowing to sewer, thereby reducing the overall volume of waste water by 60% over 2010.


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As per condition 6.5 of the IPPC license, Microtox and Respirometry were approved as the appropriate testing regimes for toxicity testing of discharges to sewer. All results were within IPPC limits specified.

Pilot trials were held over the Summer of 2010 to further assess WWT capability to deal with higher plant production rate considerations such as higher flows of DMAc.

A summary of compliance is provided below.

Parameter Frequency IPPC Mass ELV (kg/yr)

Mass Emission 2009

Mass Emission 2010

Flow Continuous 803000m 359505 m3 383899m3 3

BOD Monthly 481800 13367 12878.29

COD Monthly 963600 173900 142842.83

Suspended solids Monthly 481800 34520 38631.53

Sulphates as SO4 Monthly 240900 15245 16041.75

Copper as Cu Monthly 4015 459 1.67

Fats, Oils, Grease Monthly 16060 2983 2291.67

Phosphates as P Monthly 16060 2824 1881.90

Iodinated Compounds Monthly 240900 40199 33315.44

Chlorides Monthly 3613500 737902 792473.40

Ammonia as N Monthly 80300 4240 7678.07

Nitrates as N Monthly 20075 3996 1053.11

Kjeldahl Nitrogen Monthly 160600 12908 11898.21

Total Nitrogen Monthly 240900 14571 13931.26

Parameter Frequency IPPC ELV Emission 2010

Temperature Continuous 42o 31 max o max

pH Continuous 6 – 10 8.8 max

Toxicity Quarterly 10 TU <2.2

Organic Solvents Biannually Solvent Screen Process No elevated results

3.1.3 Emissions to Surface Water

All emissions to Surface water were within the terms of the IPPC license. On line pH and TOC analysers are in place on the surface water discharge to the River Tolka and are fed back to the DCS plant control system. These are configured to activate an alarm in the event of an excursion of pH or TOC and automatically divert any surface water flowing to the surface water to the Firewater Retention Pond.

All diversions in 2010 were fully investigated, and were normally as a result of TOC pump issues due to environmental conditions or ingress of detritus to the TOC monitoring system. Low flow in the TOC pot led to several non-conformance investigations. These resulted in the replacement of the TOC pump to reduce the impact of low liquid flow on the TOC monitoring system.


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Trends relating to TOC and pH monitoring were included in the quarterly reports to the EPA, and there was one category 3 incident notification to the EPA relating to freezing weather impacting on the TOC analyzer system. Corrective actions were put in place to prevent reoccurrence.

No spill incidents occurred in 2010 that led to any emission to surface water.

The Surface Water drainage system was subject to underground pipeline inspection as part of IPPC compliance assessment in 2009. Due to regular surface water maintenance, there was little evidence of detritus, damage or any material ingress in the system. Findings from this assessment are now being underway as a site improvement project, and will be completed to the end of 2011.

3.1.4 Waste

Overall the waste recycling on site was 34% in 2010 in comparison to 38% in 2009 and 42% in 2008 .

The recycling rate reduced slightly due to removal of stored resin and carbon waste from the site over the year following reclassification of this waste as non-hazardous through use of the analysis and application of the EPA Waste Classification Tool.

A summary table of the waste generated is included in Appendix 1 as part of PRTR reporting, and has been submitted in electronic form to the Agency.

3.1.5

Data for energy usage and water consumption is included in the Environmental Data Submission included in Appendix 2. Based on 536.16 tonnes of product produced, these are the metrics for resource consumption.

Resource Consumption

Natural Gas use is subject to production efficiency work that is being carried out and is in line with Greenhouse Gas Permit allowance and permit, and in relation to water use, a water process map is being prepared for the site to identify further reductions.

Parameter Unit 2008 2009 2010

Light Fuel Oil M3 0.57 /yr 0.58 0.82

Natural Gas M3 3960153 /yr 3679984 3,723,464

M3 8.721 /Kg Product 7.208 6.944

Electricity MWhr 11519.7 12011.7 12178.9

MWhr/kg Product

0.025

0.023 0.022

Municipal water use

m3 348684 /yr 343380 429,571

m3/kg Product 0.767

0.673

0.801


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4.

4.1 Incidents

ENVIRONMENTAL INCIDENTS AND COMPLAINTS

Please see below the summary of environmental incidents in 2010 as defined under EPA guidance on reporting of incidents.

As part of the site IPPC Licence there is a requirement to inform the Agency of any release to atmosphere from any potential emission point; any emission which does not comply with the requirements of the licence; any malfunction or breakdown of control equipment or monitoring equipment which is likely to lead to loss of control of the abatement system; and any incident with the potential for environmental contamination of surface water or groundwater, or posing an environmental threat to air or land, or requiring an emergency response by the Local Authority.

All incidents were reported to the EPA as required over the course of the year. All reported incidents were Category 3 Environmental incidents in 2010.

Date Issue Corrective Action Preventive Actions

04/01/10 Loss of SC-2051 scrubbing solution from SC-2051 Ejector pump PU-2051-31

Solution contained in bund. Diverted to process sump then on to WWTP for treatment.

Feedback from scrubber pumps and seal pot improved. All actions completed.

07/01/10 Surface water TOC analyser reading above 100mg/l due to internal fault with analyser

Service engineer contacted and fixed.

Project for TOC analyser pump change out. All actions completed.

29/03/2010 ETO Analysers not reconnected after calibration.

Analysers re-connected. Contractor contacted for report.

Inspections of EHS critical equipment implemented. Permit procedures updated. All Actions completed.

17/06/10 HCL release from tank seal leg to bund during tanker unloading

Stop tanker unloading. Effected area was washed down. Blockage cleared on SC-911. Top up seal leg undertaken. Check of conservation vent.

Process safety mechanical integrity programme being developed to address passing valves and venting. Actions completed.

19/06/10 Loss of circa 3500ltrs DI from TA-2066 to bund due to filter leakage.

Housing locked & isolated. Bund pumped to process sump. Water only.

Daily bund inspections and leak surveys reinforced. Actions completed.

08/06/10 Loss of continuous monitoring due to power outage

Visual assessment of EHS control equipment. Assessment of operation status to determine whether emissions possible. No emissions based on state of operations.

Assess safe state of operations when power outage occurs. Actions completed.


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Date Issue Corrective Action Preventive Actions

19/11/10 Scrubber and abator EtO analysers alarming due to emission from pump at low level.

Scrubber assessed and RCA undertaken. Blockages, corrosion and correct operation assessed.

PM Schedule to check for corrosion and blockages internally every 2 years. Actions completed

28/11/10 T-912 low strength water over-flowing to bund area

Bund of water pumped to T-940 and the pump was restarted.

Additional checks during cold weather required on DCS, PI with walkabouts. Actions completed.

28/11/10 TOC monitoring reading zero on surface water

System reset on the surface water system. Investigation completed.

None required. Ongoing monitoring through Pi and DCS plant monitoring system. Actions completed.

30/11/10 NPW isolation valve burst at Methanol recovery

Pump isolated, valve removed and the line was capped.

Additional walkabouts and checks for freezing weather conditions. Risk Assessment and actions list for environmental conditions compiled. Actions completed.

4.2 Complaints

No environmental complaints were received in 2010.


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5.

5.1

MANAGEMENT OF THE ACTIVITY

Covidien Pharmaceuticals Dublin is certified to the Environmental Management System Standard ISO14001:2004, and is audited externally to ensure ongoing conformance with this standard.

Covidien Pharmaceuticals Dublin Environmental Management System

The Plant Manager has overall responsibility for environmental management at the site with designated responsibilities for performance and compliance support assigned to the EHS Manager. The EHS Department comprises of three full time employees- EHS Manager, EHS Officer and EHS Engineer.

The key elements of the environmental management system comprises of identifying environmental aspects associated with site activities, the determination of suitable operational controls (engineering and administrative); the identification of pertinent legal requirements; definition and implementation of objectives and targets; ongoing monitoring of performance and compliance; and management review of performance on a periodic basis. Emergency planning and good internal stakeholder structures are also features of the system. These elements are structured to meet the requirements of both ISO14001 and Covidien Corporate requirements to provide for continual improvement in environmental performance.

5.2

The proposed EMP for 2011 – 2015 is included in Appendix 3. Additional to the programme for 2010 are the objectives and targets proposed as follows:

Environmental Management Programme Report and Proposal

a. The objective to improve the environmental incident investigation procedures.

In line with ISO 14001, all objectives in the five year plan are based on the significant environmental aspects of the site and related compliance requirements.

The status report on the success of the Environmental Management Programme 2010 is located in Appendix 4.

5.3 As per IPPC Condition 2.4, the substances for the 2010 Pollution Emission Register are:

Pollution Emission Register Report and Proposal

• Total Nitrogen (CAS No. 7727-37-9)

• 2-Chloroethanol (CAS No. 107-07-3)

It is proposed that in 2010 Total Nitrogen and 2-Chloroethanol will be reported.

Copies of the PER are in Appendix 5.


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5.4

5.4.1

Other Significant Environmental Activities

• There was one site EPA inspection carried out in 2010. There were no non-compliances noted.

EPA Inspections and Sampling

• There was one visit by Euro Environmental on behalf of the EPA to carry out air emissions monitoring. There were no non-compliances associated with this visit.

• There was a visit by the EPA to take waste water treatment samples. A split sample was taken by Covidien Pharmaceuticals Dublin at that time. There were no non-compliances associated with samples taken.

5.4.2 External Environmental Management System Audits

• A surveillance audit to ISO14001:2004 was carried out in June 2010, with a full three yearly recertification audit carried out in November 2010. There were no major non-conformances.

• The site was awarded BEST Environmental Award by Covidien Corporate for excellent environmental performance of the environmental management system at the site.

5.4.3 Energy Initiatives

• Engineering Projects following previous energy audits at the plant resulted in significant energy reduction and optimisation within process operations resulting in an additional 17% reduction in gas use/kg product from 2008 production figures, and overall a 28% reduction in gas use/kg product from 2007 production figures since the programme inception. The implementation of the programme resulted in shortlisting for award with Sustainable Energy Ireland (SEI).


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6.

There are a number of license specific reports to be provided as part of the site IPPC license on a periodic basis. A summary of the status of these follows:

LICENSE SPECIFIC REPORTS

Report Type License Requirement Report Due in AER

Noise Monitoring Every 3 years AER 2010 (March 11)

Bund and Sump Integrity Every 3 years AER 2011 (March 12)

Groundwater Monitoring Every 2 years AER 2010 (March 11)

Tank and Pipeline testing & Inspection Report

Every 3 years AER 2011 (March 12)

6.1

An environmental noise assessment was carried out in September 2010.

Noise Monitoring Report

From previous background noise surveys undertaken when the plant was shutdown, background noise levels at the nearest Noise Sensitive Location are high due to traffic on the nearby Navan dual carriage way and proximate industrial activity in Damastown Industrial estate.

During the assessment of environmental noise in 2010, there was little difference noted. Background noise levels remained high, and noise contribution from the facility did not negatively impact on adjacent premises. The nearest sensitive receptor is an adjacent pharmaceutical company.

The 2010 noise survey indicated that the contribution made to the noise environment by the Covidien facility was observed to be minimal.

The next environmental noise survey will be carried out in 2013 as required by the License.

The noise monitoring report is included in Appendix 10

6.2

Groundwater monitoring was undertaken in August 2010. During the August 2010 monitoring period, samples were obtained from six groundwater monitoring wells, namely; MW1, MW2, MW3, MW4, MW5 and MW6.

Groundwater Monitoring Report

The results of the groundwater are compared with the Groundwater Threshold Values (GTV) as set out in the Report “European Communities Environmental Objectives (Groundwater) Regulations 2010 (S.I. N o. 9 of 2010) and the EPA Interim Guideline Values (IGV) as set out in the Interim Report “Towards Setting Guideline Values for the Protection of Groundwater in Ireland”. Any parameters which exceed their respective guideline values were compared to the previous monitoring event in December 200.


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Exceedances of their respective GTV’s and IGV’s have occurred for the following parameters:

Inorganics: Calcium (MW2, MW3, MW4, MW5, MW6), Magnesium (MW5), Sulphate (MW2,MW5).

Metals: Iron (All wells), Nickel (MW2, MW3, MW4, MW5), Manganese (All wells), Zinc (MW-5), Arsenic (MW1), Aluminium (All wells), Barium (All wells), Cadmium (MW2, MW3, MW4).

Results indicate negligible impact from the site on groundwater. Where elevated results were found, these were noted in both up gradient and down gradient wells with the exception of magnesium and sulphates which were found in down gradient wells only. There are no sources of magnesium or sulphate stored or used on the site and this do not bioaccumulate so it is not believed to be a contribution from site activities.

The result of the monitoring event show general groundwater improvement compared to the December 2008 monitoring event. There has been a significant drop on the concentration of many heavy metals, with less exceedance noted. Exceedances in VOC’s and Hydrocarbons which were previously noted were undetected for this monitoring event.

The Groundwater Monitoring Report 2010 can be found in Appendix 6.

6.3

Bund and Sump testing was started in 2010 in line with IPPC requirements. A report on bund and sump condition is required in March 2012.

Bund and Sump Integrity Reports

All bunds are under a process of reassessment since August 2010 as to structural integrity through inspection and through water integrity testing where practical and safe to do so.

Sump testing has not been possible on all structures to date due to production requirements and lack of ability to control sump inflows outside of shutdown periods. This will be undertaken during the bi-annual shutdown in September 2010.

The last extensive surveying and work on tank bunds and underground sumps was undertaken in 2008. Extensive investment was conducted in 2008 in bund replacement and repair. A copy of this report was submitted as part of the AER in 2009.

All bund upgrades, volume determination and rechecks were undertaken in line with recommendations from the 2008 assessment.

Daily and weekly visual checks are undertaken on all structures, and where any issues arise, these are dealt with within the site maintenance.

The Bund and Sump Integrity Report 2010 can be found in Appendix 7.


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6.4

As per condition 9.4.5 of the IPPC license CCTV surveys were carried out in 2009 to inspect and test underground pipeline systems including surface water, effluent and foul sewers. This process of inspection was completed by February 2010 due to operational constraints. At the site, there are no underground pipelines or tanks storing hazardous materials on site.

Tank and Pipeline Inspection Report

In undertaking CCTV surveys, no high risk issues were identified with underground pipework that could lead to significant environmental impact. Where further checks and repairs have been identified as being required, these will continue to be undertaken until completed.

Over ground tank and pipeline inspection is carried out on site as part of a comprehensive Preventive Maintenance Programme involving daily and weekly walkabout, and equipment specific PM routines. There were no leaks or failures involving any risk to the environment from overground tanks or pipelines in 2010.

6.5

This report was completed in 2004 and is available for inspection on site. The principal conclusion was that a ca. 7.5 % reduction in the amount of 2-Chloroethanol was planned to be achieved from mid 2002 onwards. The actual achieved was ca. 10.5 % in 2003. The process is now fully optimised in terms of the use of 2-Chloroethanol.

Report on List I and II Substance Reductions

6.6

The Residuals Management Plan (RMP) was submitted to the Agency in December 2002 and approved by the Agency in March 2002. This was subject to confirmation of the financing of the plan which was provided to the Agency in June 2002. Subsequently, an updated RMP was then submitted for approval to the Agency in April 2007.

Review of Closure, Restoration and Aftercare Management Plan

A Closure, Restoration and Aftercare Management Plan (CRAMP) was then reviewed by an independent consultant and submitted to the Agency for agreement in May 2007.

Financing of the plan continues to be subject to corporate review with inflation added on an annual basis (currently 5% annually).

A copy of the CRAMP report is located in Appendix 8.

6.7

An Environmental Liabilities Risk Assessment review was conducted in April 2007. This was submitted for agreement to the Agency for agreement in May 2007.

Review of Environmental Liabilities Risk Assessment

A copy of the Environmental Liabilities Risk Assessment report is located in Appendix 9.


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6.8

In 2008, an energy map project was undertaken on site in conjunction with SEI. A key focus for 2009 was energy reduction in line with the projects identified as part of the mapping exercise. Following from implementation of these improvements in 2009, investigations and changes in the design of steam production and condensate systems has led to significant savings in energy. A gas reduction project which entailed installation of alternative energy technology for process water removal reducing the requirement for steam processing led to short listing for an energy award with SEI.

Energy Efficiency Audit

In 2010, the focus on energy efficiency continued with production efficiency projects to optimise resource use thereby increasing energy efficiency requirements.

In line with environmental objectives and targets, 7% electricity reduction/kg product on 2007 figures has been achieved and 34% gas reduction/kg product.


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7.

In ensuring ongoing compliance of the site to the IPPC License, and the ongoing commitment of the company to the pursuit of excellence in environmental performance, the site continued to demonstrate strong environmental performance in 2010.

CONCLUSIONS

There were no non-compliances noted and no incidents of environmental importance.

The site has continued to succeed in progressing and delivering on the agreed environmental programme with excellent success especially in the areas of resource optimisation and energy reduction. This was primarily as a result of the implementation of energy projects following from the site energy audits and investigations carried out over 2007 and 2008.

Increased management of environmental monitoring criteria at plant level, and an increased focus on compliance criteria embedded to the company has resulted in increased ownership and awareness of environmental requirements and performance across the plant.

The site wishes to continue to operate to a very high standard in environmental performance, and is committed to maintaining good stakeholder relations with the Agency, public and surrounding community in providing good environmental protection.


FILE 2 MAIN BODY + APPEN 1 COVER

APPENDIX 1

ELECTRONIC ENVIRONMENTAL DATA SUBMISSION


APPENDIX 2

IPPC EMISSIONS SUMMARY


Summary of IPPC Emissions

Energy Usage

Energy Consumption Sulphur Content Unit 2008 2009 2010

Heavy Fuel Oil M3/yr 0 0 0

Light Fuel Oil 0.05% M3/yr 0.57 0.58 0.82

Natural Gas 0.0007 M3/yr 39601526 3679984 3723464

Electricity MWhr 11519.7 12011.7 12178.9

Coal Kg/yr 0 0 0

Water Unit 2008 2009

On-site groundwater use m3/yr 0 0 0

On-site surface water use m3/yr 0 0 0

Municipal water use m3/yr 348684 343380 429571

Process Emissions to Waters

Indicate Yes if emissions are to: Freshwater or Sewer

No Yes

Parameter Unit

Max. Licensed Emission per

year 2008 2009 2010

Volume M3/yr 803000 327612 349505 383899

Suspended Solids Kg/yr 481800 42084 34520 38631.528

BOD Kg/yr 481800 24872 13367 12878.289

COD Kg/yr 963600 123948 173900 142842.83

Total Dissolved Solids Kg/yr Not Applicable

Total Nitrogen Kg/yr 240900 19118 14571 13931.255

Total Phosphorous Kg/yr 16060 3424 2824 1881.9

Toxicity Max. TU 10 <2.2 <2.2 <2.2

Hg Kg/yr Not Applicable

Cd Kg/yr Not Applicable

Pb Kg/yr Not Applicable

Cr Kg/yr Not Applicable

As Kg/yr Not Applicable

Zn Kg/yr Not Applicable

Cu Kg/yr 4015 65 459 1.6749327

Ni Kg/yr Not Applicable

Sulphates Kg/yr 240900 28392 15245 16041.751


Fats ,Oils ,Grease Kg/yr 16060 1575 2983 2291.6712

Iodinated Compounds Kg/yr 240900 36465 40199 33315.437

Chlorides Kg/yr 3613500 635950 737902 792473.4

Ammonia Kg/yr 80300 4602 4240 7678.0718

Nitrates Kg/yr 20075 1033 3996 1053.112

Kjeldahl Nitrogen Kg/yr 160600 10299 12908 11898.211

% Compliance % 100 99.7 100

Number of samples 525 590 602

Emissions to air

Parameter Unit

Max. Licensed Emission per year 2008 2009 2010

General Dust Kg/yr 6622.6 186.4 216.39 178.86

Particulates Kg/yr 481.8 - 134.4 -

Sox Kg/yr 3372.6 - 134.4 -

Nox Kg/yr 19272 - 17392.85 13504

CO Kg/yr 9636 - 134.4 135

TA Luft Class I Kg/yr 876 8.764 19.704 26.304

TA Luft Class II Kg/yr 17520 36.246 18.872 11.945

TA Luft Class III (Car & Inorg) Kg/yr 2628 17.524 17.472 15.24

Total Organic (as C) Kg/yr Not Applicable

Non-Methane VOC Kg/yr Not Applicable

Ammonia Kg/yr Not Applicable

Total Heavy Metals Kg/yr Not Applicable

Benzene Kg/yr Not Applicable

PAHs Kg/yr Not Applicable

Dichloromethane Kg/yr Not Applicable

PCDDs/PCDFs Kg/yr Not Applicable

% Compliance % 100 100 100

Number of samples 27 28 28


APPENDIX 3

PROPOSED ENVIRONMENTAL MANAGEMENT PROGRAMME 2011-2015

Update on EMP for 2011 – 2015

1

Aspect no.

Aspect No. Objective 2011 2012 2013 2014 2015

1 Emissions to air

1 Phase out ozone depleting compounds on site 50% 100% 2 Replace the EtO (scrubber) abator 100

%

3 Meet CO2 100 % emission allowances by: 100 % 100 % 100% 100%

8 & 12 General &

Recyclable waste

4 To increase the recycling rate to: 36% 38% 39% 40% 42%

5 Use of water

5 To decrease the civic water usage on-site from 2009 figures based on kgs of Ioversol produced by:

1% 2% 3% 4% 5%

6 Use of energy

6 Reduce the Electricity usage on-site based on kgs of Ioversol produced from 2009 figures year on year by:

1% 2% 3% 4% 5%

7 Reduce the gas consumption on site based on kgs of Ioversol produced from 2009 figures year on year by:

1% 2% 3% 4% 5%

14 Release to sewer

8 Investigate the process liquid waste relationships and WWT control parameters to determine whether it is possible to reduce and control the chemical burden on the waste water treatment plant & reduce releases to foul sewer.

50% 75% 100%

N/A Management systems

9 Improve internal incident investigation procedure for environmental incidents 100%

13 Releases to Waste Water treatment plant

10 Increase the recovery rate of DMAC to the following rates year by year (with result of 67.5 % by 2015 or <0.4kg/kg Ioversol):

65% 65.5% 66% 67% 67.5%

11 Increase the recovery rate of Methanol to the following rates year by year (with result of 97.5 % by 2015 or <0.4kg/kg Ioversol):

97.0% 97.2% 97.3% 97.4% 97.5%

2&3 Releases to land & surface water

12 Prevent deterioration of ground water resources through implementation of underground pipeline report requirements

75% 100%


1

Environmental Objective Number: 01

Scope: To phase out ozone depleting compounds on site

Related to: Ozone depleting compounds Legislation

Target date: 100% by 31/12/2012

Project Summary: The aim of this project is to ensure that the site complies with the expected legislation implementation date of 2012.

Responsibility:

Action Responsible Date

List all locations & volumes of Ozone depleting compounds on site

DM Complete

Identify suitable replacements

ND Complete

Phase in 50% replacements

ND Complete

Phase in the remainder 50% replacements of R-22

ND Complete

Determine any other replacement requirements for next phase of legislation

ND 30/06/11

Determine any further capital requirements

ND 30/12/11

Implement project of replacement

ND 30/12/12

Investment: Costs to be determined


2


Scope: To upgrade and replace the current EtO scrubber abator system

Related to: IPPCL under “emissions to air “and previous EPA Category 3 environmental incidents.

Target date: 100% by 31/12/2011

Project Summary: The aim of this project is to upgrade/replace the current EtO scrubber abator used to treat production emissions. This will be in line with the best available technology.

Responsibility:


Review of current available (BAT) technology

ND Complete

CER generation ND Complete

Detailed design ND Complete

EPA Approval ND/EHS In progress

Installation ND 31/06/2011

Commissioning ND 31/12/2011

Investment: TBC estimated to be in the region of €400k


3


Scope: Meet GHG CO2

emissions allowances

Related to: IPPCL under “emissions to air” and Green House Gas permit IE-GHG019-02

Target date: 100% for 2011 of the NAP II allowances.

Project Summary: The aim of this objective is ensure that we meet the MAPP II greenhouse gas allowances and reduce our overall CO2

emissions where possible.

Responsibility:


Monthly Monitoring of gas bills

ND 31/12/11

Assess impact of new greenhouse gas legislation

MOL 31/12/11

Determine actions required to site to meet changes and allowances.

MOL 30/06/11

Implement changes as required

MOL 31/12/11

This objective is linked to objectives No. 6 and 7.

Investment: None


4


Scope: To increase the recycling rate to 40% by 2014

Related to: IPPCL under “waste “and Irish Legislation

Target date: By 31/12/2014

Project Summary: The aim of this project is to increase the recycling rate on-site and thus reduce the amount of waste going to landfill.

Responsibility:


Roll out waste awareness presentation to all employees on-site.

EHS Complete (Mar 2010)

Implement viable waste recycling initiatives suggested during waste awareness presentations.

EHS (+ relevant departments)

01/12/2010

Review hazardous waste classifications on site.

EHS 31/12/2010

Assess waste streams across plant through process flow. Determine opportunities for further recycling.

EHS 31/12/2011

Implement waste reductions and recycling opportunities.

EHS 31/12/2011



5


Scope: To reduce the electricity usage on-site based on 2009 figures of kgs of Ioversol produced by 5%

Related to: IPPCL under “Energy usage “

Target date: 31/12/2014

Project Summary: The aim of this project is reduce the amount of electricity used per kg of Ioversol produced thus reducing the overall amount of natural resources consumed by the site.

Responsibility:


Conduct energy consumption review - SEI energy map

EHS Complete

Conduct energy awareness training with all employees.

EHS Complete

Conduct detailed energy audit and mapping

ENG (CC) In Progress

Implement recommendations

ENG 2014



6


Scope: To reduce the gas usage on site based on 2009 figures of kgs of Ioversol produced by 5%

Related to: IPPCL under “Energy usage “

Target date: 31/12/2014

Project Summary: The aim of this project is to reduce the quantity of gas consumed to produce Ioversol thus reducing the overall amount of natural resources consumed by the site.

Responsibility:


Install fuel conditioning system

COG Complete

Conduct HVAC design review

CC Complete

Review further reduction opportunities

ND 01/12/2011



7


Scope: Investigate liquid process waste streams and WWTP biology to determine whether it is possible to reduce the chemical burden on the waste water treatment plant & further reduce emissions to sewer.

Related to: Emissions to sewer

Target date: 100% by 31/12/2013

Project Summary: The aim of this project is to determine whether it is possible to further reduce the chemical burden on the WWTP and further reduce emissions to sewer.

Responsibility:


Conduct WWTP pilot trials EHS/BOR/ TOF Complete

Implement recommendations as a result of pilot trials.

EHS 01/12/2010

Assessed and underway

Assess viability of pre-treating DMAc before WWT.

BC/BOR/TOF 01/08/2010

Assessed and not viable

Assess further DMAc recovery options and relationship with WWT.

EHS & Production 31/12/12

Implement upgrades to WWT monitoring for further control

Engineering 30/06/13



8


Scope: Improve the internal environmental incident investigation procedure

Related to: N/A

Target date: 100% by 01/12/2010

Project Summary: The aim of this project is to streamline and improve the methods of reporting and addressing environmental incidents relating to environmental compliance to ensure awareness of staff in what needs to be reported; to provide means and tools to investigate all issues to root cause and determine adequate actions to prevent reoccurrences.

Responsibility:


Review existing incident management process

EHS 30/03/11

Identify any gaps or room for improvement in plant level investigation relating to IPPC conditions.

MOL 30/06/11

Train employees and audit conformance to new incident management process.

MOL 31/12/11

Investment: None



9

Scope: To increase the DMAC recovery on-site to 67% by 2014 or <0.4kg/kg Ioversol

Related to: Aspect No 13


Project Summary: The aim of this project is increase the amount of DMAc recovered which will reduce the amount of DMAc purchased and the amount being sent to the waste water treatment plant.

Responsibility:


Conduct mass balance of system to identify all potential loss points. Identify opportunities for recovery improvement for 2011.

ENG (RD) 01/12/2011

Recommendations to be implemented

ENG 31/12/2014



10


Scope: To increase the Methanol recovery on-site to 97.4% by 2014



Project Summary: The aim of this project is increase the amount of methanol recovered which will reduce the amount of methanol purchased and the amount being sent to the waste water treatment plant.

Responsibility:


Change the packing in the MeOH column to increase recovery efficiency.

BOR/ ND 01/12/2011

Not possible in 2010 due to freezing weather impacts. Due in shutdown 2011.

Full review of MeOH recovery process to identify further opportunities for recovery improvement.

ENG 01/12/2012

Recommendations from process review to be implemented.

BOR & ENG 01/12/2014




Scope: To prevent deterioration of ground water resources


Target date: 100% by 31/12/11

Project Summary: The aim of this project is ensure all underground pipework is adequately maintained to ensure there are no impacts to groundwater

Responsibility:


Review underground pipeline reports for surface and foul water

EHS Complete

Based on report reviews, plan work with engineering and utilities

EHS & Engineering 31/12/11

Implement checks and repairs as determined by report

Utilities & Engineering 31/12/12



APPENDIX 4

ENVIRONMENTAL MANAGEMENT PROGRAMME REPORT 2010

Environmental Management Programme: Status of Objectives and Targets 2010 Aspect

no. Aspect No. Objective 2010 Target Actual

1 Emissions to air

1 Phase out ozone depleting compounds on site 100% Complete for R-22 as determined by legislation.

2 Replace the EtO (scrubber) abator 50% Complete.

Specified and planned.

3 Meet CO2 100% emission allowances by: Complete

GHG submission & verified

8 & 12 General &

Recyclable waste

4 To increase the recycling rate to: 34% Complete

34% recycling rate.

5 Use of water

5 To decrease the civic water usage on-site from 2009 figures based on kgs of Ioversol produced by:

0.5% Complete

6 Use of energy

6 Reduce the Electricity usage on-site based on kgs of Ioversol produced from 2009 figures by:

1% Complete

7 Reduce the gas consumption on site based on kgs of Ioversol produced from 2009 figures by:

1% Complete

14 Release to sewer

8 Investigate the process liquid waste to determine whether it is possible to reduce and control the chemical burden on the waste water treatment plant & reduce releases to foul sewer.

100% Complete

N/A Management systems 9 Improve internal non conformance AAR system. 100% Complete

13 Releases to Waste Water treatment plant

10 Increase the recovery rate of DMAC to:

64.5% Complete

65.28% Recovery

11 Increase the recovery rate of Methanol to: 96% Complete

96.83% Recovery

2&3 Releases to land & surface water

12 Prevent deterioration of ground water resources through implementation of underground pipeline report requirements

50% 50%


APPENDIX 5

POLLUTION EMISSION REGISTER REPORT 2010

Covidien Pharmaceuticals Dublin

POLLUTION EMISSION REGISTER 2010

Licensee: Mallinckrodt Medical Imaging Ireland Damastown Industrial Estate Mulhuddart Dublin 15 Licence No: P0050-02

Approved by: Sharon Mulvey EHS Manager

Submission Date:

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1

This is the Pollution Emission Register of Mallinckrodt Medical Imaging Ireland (trading as Covidien Pharmaceuticals Dublin) as per Condition 2.4 of the Integrated Pollution Control Licence No. P0050-02.

INTRODUCTION

The substances for the 2010 Pollution Emission Register are:

• Total Nitrogen (CAS No. 7727-37-9)

• 2-Chloroethanol (CAS No. 107-07-3)

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2

2.1

MASS BALANCES

2.1.1 Process Description

TOTAL NITROGEN

N,N,Dimethylacetamide (DMAc) is charged to the process from a bulk tank in the tank farm. The DMAc molecule is ca. 16.1% nitrogen. The second source of nitrogen is the raw material for the process (MP-104). This comprises 6.0% nitrogen. The product, Ioversol, comprises 5.2% nitrogen. The nitrogen remaining in the waste water treatment effluent discharged to Sewer is measured as part of the IPPC license requirements. The emission to air, comprising largely nitrogen as a result of nitrification / denitrification in the waste water treatment plant is estimated by difference.

We maintain a high proportion of nitrifying bacteria in the waste water treatment plant. We monitor the ammonia levels closely as this parameter is a good indicator of the operation of the nitrification / denitrification process.

2.1.2 Final Mass Balance A final mass balance for Total Nitrogen is shown below. This is based on the actual usage data for year 2010.

The quantities in Streams 1 and 2 are based on actual purchases. Stream 3 is based on measurements. Stream 5 is based on measurements. Stream 4 is estimated by difference.

The emissions to air are predominately pure nitrogen from the nitrification / denitrification processes in waste water treatment.. We have estimated from previous PER work on DMAc that only 6.7 kgs of this total quantity relates to fugitive losses of pure DMAc.

Stream No. 1 2 3 4 5

Description. MP-104 In

(as N)

DMAc in

(as N)

Product Out

(as N)

Emit to Air

(as N)

Emit to Sewer

(as N)

Kgs p.a. 32748 42672 27934 32915 14571

% 37.0% 43.6% 19.3%

Process WWT

Product

3

Air

4

MP-104

1

DMAc

2 Sewer

5

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2.1.3 Fugitive Emissions Estimates from previous mass balances for DMAc indicated that the total fugitive emissions associated with this material are ca. 42 kg/yr comprising ca, 6.7 kg of N. This represents ca. 0.01 % of the total nitrogen input. This shows the negligible extent of fugitive emissions of DMAc.

2.2

2.2.1 Process Description

2-CHLOROETHANOL (CE)

2-Chloroethanol is charged to the process from 200 litre drums in a dedicated drum charging area. A portion of the Chloroethanol is reacted as part of the manufacturing process. The remainder is chemically destroyed by treatment with sodium hydroxide to form ethylene glycol. The waste water is treated in the on site waste water treatment facilities. The vents from the vessels containing Chloroethanol are directed to the catalytic abator.

The destruction routes for CE have been verified by measurements at the Abator Outlet, the CE destruction vessel and the outlet to the sewer. Additional measurements of these locations made during 1999 have been used to verify the balances in the above table.

2.2.2 Final Mass Balance A final mass balance for 2-ChloroEthanol is shown below. This is based on the actual usage data for year 2010

3

5

2-Chloroethanol

1

4a 4b 4c 4d

4

1a Process facilities

2 Waste Water Treatment

Discharge tosewer

4e 4f

1b CEDestruction

Stream No. 1 1a 1b 2 3 4a

Description CE in CE Reacted CE Destroyed

Degraded in WWT

Emit to Sewer

Drum Charge Losses

Kgs p.a. 183755 62274.570 121443.765 5.880 0.000 0.008

% 100 33.89 66.090 0.003 0 0.000

Stream No. 4b 4c 4d 4e 4f 5

Description ETO Abator Outlet

Building Vent Losses

Air Strip Loss

HS Waste Tank

Other Fugitive

To offsite incineration

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Losses

Kgs p.a. 30.062 0.237 0.215 0.263 0.000 0.000 % 0.01636 0.00013 0.00012 0.00014 0.00000 0.00000

The quantity in Streams 1 is based on the number of batches manufactured. Streams 2, 3, 4a, 4b, 4c, 4d are based on past measurements. Stream 1a is based on stoichiometry. Stream 4e is based on an estimate based on a measurement of TOC. Stream 1b is estimated by difference. No Chloroethanol is sent for incineration offsite.

The above table shows that the mass balance is close to less than 0.01%. This is well within the 15% allowance for existing plant (and the 5% allowance for new plant) under EU Directive 1999/13/EC.

2.2.3 Fugitive Emissions The measurements for the mass balance indicate that the extent of fugitive emissions (streams 4a, 4c, 4d, 4e) amount to less than 0.5 % of the solvent input. These values show the negligible extent of fugitive emissions of 2-Chloroethanol in the process.

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3

3.1

FUTURE DEVELOPMENTS

As the total nitrogen discharge to Sewer is 6% of the licence limit we consider that the material is under excellent control with no negative impact arising. We believe that no further reduction measures are warranted at this time.

TOTAL NITROGEN

Covidien Pharmaceuticals Dublin will endeavour to minimise the amount of nitrogen being discharged to sewer by ensuring that the treatment facilities operate to optimise the degradation of nitrogen containing wastes. The objective will be to remain within our licence limits on all parameters at all times.

3.2

The overall reduction achieved since the CE usage optimisation commenced in 2002 is in excess of 10%. No further optimisation is planned at this time due to process chemistry constraints.

2-CHLOROETHANOL (CE)

Covidien Pharmaceuticals Dublin will endeavour to minimise the amount of all solvents being directed to waste water treatment and will ensure that the treatment facilities operate to optimise the degradation of these wastes. The objective will be to remain within our licence limits on all parameters at all times.

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4

The treatment of nitrogen containing compounds is well controlled and the destruction routes are well documented and environmentally friendly with no negative environmental impact.

CONCLUSIONS

The use of 2- Chloroethanol is well controlled and the destruction routes are well documented and very environmentally friendly with no negative environmental impact.

Appendix A

Pollution Emission Register Form

Pollution Emissions Register

PER does not apply to your license, please tick here

Input

Outputs

Pollutant Name CAS No. Input Gross Usage

Emissions to air MOM

Emissions to waters MOM Waste MOM Product MOM Recovery Treated Unaccounted

2-Chloroethanol 107-07-3 183755 183755 30.78 C 0 M 5.88 M 62274.57 M 0 121443.76 0

Total Nitrogen 7727-37-9 75420 27934 32915.18 E 14571 M 0 C 27934 M 0 0 0


APPENDIX 6

GROUNDWATER MONITORING REPORT 2010

For the Attention of: Prepared by: Ms. Meabh O’Loughlin Mr. Eamonn Lee EHS Engineer, Environmental Scientist Covidien Pharmaceuticals, Damastown Industrial Estate, Reviewed by: Mulhuddart, Mr. Peter Coogan Dublin 15. Monitoring Team Leader

Report No: ECS3724-GW Monitoring Date: 2nd September 2010 Reporting Date: October 2010 This report shall not be reproduced except in full, without the approval of Bord na Móna Technical Services.

All queries concerning the report or its contents should be forwarded to the Monitoring Team leader.

BIENNIAL IPPC COMPLIANCE

MONITORING OF GROUNDWATER AT

MALLINCKRODT MEDICAL IMAGING

IRELAND, DAMASTOWN, MULHUDDART,DUBLIN 15.

IN ACCORDANCE WITH IPPC LICENCE

P0050-02

Mallinckrodt Medical Imaging Ireland Report No. ECS3724-GW

Bord na Móna, Technical Services Page 2 October 10

EXECUTIVE SUMMARY

The Mallinckrodt Medical Imaging Ireland site was visited by two Bord na Móna Environmental Scientists on the 2nd of August 2010 for the purpose of conducting the company’s biennial groundwater monitoring programme for the 2009/2010 monitoring period, in accordance with IPPC Licence Reg. No. P0050-02.

During the August 2010 monitoring period, samples were obtained from six groundwater monitoring wells, namely; MW1, MW2, MW3, MW4, MW5 and MW6.

The results of the groundwater are compared with the Groundwater Threshold Values (GTV) as set out in the Report “European Communities Environmental Objectives (Groundwater) Regulations 2010 (S.I. N o. 9 of 2010) and the EPA Interim Guideline Values (IGV) as set out in the Interim Report “Towards Setting Guideline Values for the Protection of Groundwater in Ireland”. Any parameters which exceed their respective guideline values are compared to the previous monitoring event in December 2008 (See URS Report - 49341670).

Exceedences of their respective GTV’s and IGV’s have occurred for the following parameters:

Inorganics -Calcium (MW2,MW3,MW4,MW5,MW6), -Magnesium (MW5)

-Sulphate (MW2,MW5),

Metals - Iron (All wells), - Nickel (MW2,MW3,MW4,MW5)

- Manganese (All wells), - Zinc (MW-5), - Arsenic (MW1), - Aluminium (All wells) - Barium (All wells) - Cadmium (MW2, MW3, MW4)

The result of the monitoring event show general groundwater improvement compared to the December 2008 monitoring event. There has been a significant drop on the concentration of many heavy metals, with less exceedence noted. Exceedences in VOC’s and Hydrocarbons which were previously noted were undetected for this monitoring event. Respectively Submitted, ___________________________ ___________________________ Mr. Eamonn Lee Mr. Peter Coogan Environmental Scientist Monitoring Team Leader



CONTENTS

1.0 INTRODUCTION

2.0 METHODOLOGY

2.1 Borehole Locations 2.2 Representative Groundwater Sampling 2.3 Analysis

3.0 ENVIRONMENTAL SETTING

3.1 Surrounding Land Use 3.2 Geology and Hydrology

4.0 COMMITMENT TO QUALITY

4.1 INAB Accreditation 4.2 Interlaboratory Proficiency Schemes 4.3 Control Chain of Custody

5.0 RESULTS 6.0 DISCUSSION

APPENDICES

APPENDIX 1: Drawing Illustrating Groundwater Flow Direction and Monitoring Locations.

APPENDIX 2: USEPA 524.2 Compound Listing



1.0 INTRODUCTION

In accordance with the company’s IPPC Licence, Register No. P0050-02 [Schedule 4 (ii)], Mallinckrodt Medical Imaging Ireland is required to conduct a biennial monitoring programme of the groundwater monitoring boreholes at their site. Bord na Móna Technical Services was commissioned to perform the sampling and analysis for this monitoring event. The site was subsequently visited by two Bord na Móna Environmental Scientists on the 2nd of September 2010 to carry out a groundwater monitoring event. Groundwater samples were subsequently returned to the Bord na Mona INAB accredited laboratory in Newbridge, Co. Kildare for analysis. This report outlines the accurate sampling and analytical methodologies adopted, including an interpretation of the results obtained. The Mallinckrodt Medical Imaging Ireland site is located in Damastown, Mulhuddart, Co. Dublin, as shown in Figure 1.1 below. Figure 1.1 Site Location Map



2.0 METHODOLOGY

2.1 Borehole Locations

The locations of all groundwater monitoring boreholes (MW-1, MW-2, MW-3, MW-4, MW-5 and MW-6) are presented in Table 2.1 below, and are illustrated on the site map provided in Appendix 1.

TABLE 2.1:LOCATION OF GROUNDWATER MONITORING BOREHOLES Borehole ID Location

MW-1 North of site Approx. 50m west of fire pump house

MW-2 Eastern boundary of site Near contractors portacabin offices.

MW-3 South of site Approx. 6m west of the south east car-park

MW-4 Western boundary of site Midway along established electric fence-wire

MW-5 North-east boundary of site Approx. 25m north of contractors entrance

MW-6 South-east boundary of site On grass lawn south east of main reception area.

2.2 Representative Groundwater Sampling Groundwater’s were extracted in accordance with the following recognised standards;

ISO Standard Description

ISO 5667-1-2006 Guidance on the design of sampling programmes and sampling techniques

ISO 5667-3-2004 Guidance on sample preservation and handling ISO 5667-14-1998 Guidance on quality assurance of environmental sampling &

handling ISO 5667-11-2009 Guidance on sampling groundwater’s

Groundwater in the well casing and in close proximity to the well is not considered representative of the general groundwater at a given location. In order to ensure that the groundwater samples extracted from the monitoring bores were representative of the water held in the subsurface strata and not water held stagnant in the borehole casing, it was necessary to evacuate the monitoring bores prior to sampling. A common procedure is to pump a well until between 2 and 6 bore volumes have been removed as cited in Bord na Móna Environmental Ltd’s Standard of Field Protocols (SOP) and as recommended in numerous technical publications (e.g. Marsh and Lloyd 1980 and



Boateng 1987). The purged volumes were calculated on-site from the measured static water levels (measured using an electronic well dipper) and the total depth of the bores. In order to ensure the efficiency of the evacuation procedure, the temperature and conductivity of the extracted water was continually monitored. Evacuation was deemed to be complete on stabilisation of both parameters. Therefore samples were extracted for both non-volatile and volatile organic analysis from the monitoring wells after purging the required volumes from each of the monitoring boreholes and on stabilisation of the parameters outlined above.

The "Waterra inertial lift pump" system was used to evacuate all of the monitoring bores. The system comprises of three main components:

a. Manual drive HDPE

b. Riser tubing (HDPE or Teflon) c. Non return foot value

The required length of tubing was cut so as to allow a 1–m excess above the top of the well casing. A non-return stainless steel foot valve was fitted to the bottom of the tubing and inserted into the bore to the required depth. The pump was operated by vertically oscillating the tubing in the bore. A discharge rate of 2 - 3 l min-1 was achieved using the system described. Separate tubing and foot valves were used at each monitoring bore to eliminate the possibility of cross contamination.

The methodology for sampling of the boreholes for organics are as follows:

(i) A 1–m long narrow diameter Waterra organic sampling bailer is inserted (2 to 5m) into the wider diameter riser tubing.

(ii) Samples from the narrow bore tubing are filled directly into a 100 ml amber conditioned bottle with a PTFE stoppered lid. The sampling bottles are brim filled.

(v) Separate VOC sampling tubes are used at each monitoring borehole.

(vi) Samples are taken in 1 litre polypropylene containers (inorganic) and 100–ml PTFE capped glass bottles (organic), returned to the laboratory for immediate analysis.

All samples were returned to the laboratory, and stored between 1-8°C.



2.3 Analysis

All samples returned to the laboratory were stored at 1 - 8°C. Subsequent analysis of all samples was carried out in strict accordance with recognised standard methods as detailed in Table 2.2 below

TABLE 2.2: METHODS AND LIMITS OF DETECTION PARAMETER METHOD L.O.D. / Range

pH (pH Units) G/05 0.1 - 14

COD (mg/l) Based on APHA, 2005, 21st Edition, 5220D, Closed Reflux, colourimetric

method. (G/03) <10 mg/l COD

USEPA list 524.2 Volatile Organic Compounds (VOC) µg/l

Headspace GC-MS <10µg/l

Speciated Total Petroleum Hydrocarbons Gas Chromatography <10

Major Anions (mg/l)

Ion Chromatography

<0.2mg/l NO3-N <0.01 mg/l PO4-P <0.02mg/l NO2-N

<2 mg/l Cl

Major Cations G/57 ICP-MS Hg <1µg/l

Fe <0.1mg/l Others: <2µg/l

Total Alkalinity (mg/l) Based on standard methods for examination of water +waste-water, 2005, 21st edition,

4500-P.E.

<10 mg/l

GC-FID scan (Methanol, Ethanol, Acetone, IPA, Acetonitrile (mg/l)

Based on ASTM Method D3695. (G/14) <0.5 mg/l

NOTES APHA American Public Health Association, Standard Methods for the Examination of Waters and Wastewaters, 20th Edition, 1998. ASTM American Society for Testing Materials, Annual Book of ASTM Standards 1997 G = Bord na Móna Environmental Technical Services Analytical Laboratory Standard Operating Procedures Manual < = Less than



3.0 ENVIRONMENTAL SETTING

3.1 Surrounding Land Use The Mallinckrodt Medical Imaging Ireland facility is located in Damastown, Mulhuddart, Co. Dublin in a predominantly industrial area. Other facilities in the area include Yamanouchi Ireland Ltd., IBM, Henkel, Barclay Chemicals, Helsinn Pharmacueticals and Kepak. The topography in the vicinity of the site is generally flat. Resedential developments are located approximately 1.5 kilometres to the east and southeast (Mulhuddart) with the nearest private residences located approximately 1km to the west and north of the site. There have reportedly been no historical incidents at the site that would have affected groundwater quality and currently there are no known licensed operational emissions to ground.

3.2 Geology and Hydrology According to the Geological Survey of Ireland (GSI) the site is underlain by dark-grey to black limestone and shale of the Calp formation. This formation is generally unproductive but with some high yielding zones. During sampling, the depth to the water level below the top of the plastic pipe level (mbpl) was recorded for each of the monitoring wells. All wells were previously surveyed by Murphy Surveys Limited and results tied into the Malin Head Datum. Both the field measurements and survey data were used to determine groundwater flow direction. The results of field measurements taken at each monitoring borehole are presented in Table 5.1. The site is located between the River Pinkeen to the north and the River Tolka to the south. The resultant groundwater flow direction is influenced by both these rivers with shallow groundwater on the northern side of the site flowing to the northeast and shallow groundwater on the southern side of the site flowing to the southeast.



4.0 COMMITMENT TO QUALITY

4.1 INAB Accreditation

Bord na Móna Technical Services analytical laboratories is accredited to ISO 17025 by the National Accreditation Board (INAB). ISO 17025 accreditation ensures that the laboratory operates a quality system with technically competent staff. The laboratory has accreditation since 1997 and it is the policy of the laboratory to achieve and maintain a high standard of quality consistent with client's requirements in all aspects of the work carried out within the laboratory.

4.2 Interlaboratory Proficiency Schemes

To ensure the accuracy of the analytical testing the laboratory participates in several external proficiency schemes. The ongoing competence of the laboratory and its staff is assessed by participation in various inter-laboratory proficiency testing schemes, such as LGC Aquacheck scheme and the EPA Intercalibration programme organised for environmental laboratories throughout Ireland. Bord na Móna Technical & Laboratory Services Analytical Laboratoriy is listed on the EPA’s register of Quality Controlled Laboratories

4.3 Control Chain of Custody

As part of the Quality System in place in Bord na Móna, Technical Services., measures are taken to ensure controlled chain of custody. An outline of the chain of custody is given overleaf.



CONTROLLED CHAIN OF CUSTODY

SITE TRANSPORT LABORATORY

Sampling and packaging of all samples were

carried out by Bord na Móna Technical Team:

Mr. Eamonn Lee & Mr. Peter Coogan

Transport Document

Form

Transport to laboratory by Bord na Móna

Technical Team.

Sample Reception

Form

Receiving of samples at Bord na Móna Environmental Laboratory complex

by: Laboratory Manager

(Secure laboratory complex access to authorised personnel only)

→ → ↓

Storage of all samples for 1 month period after report issue.

↓

Supervised Disposal



5.0 RESULTS

The results of the onsite investigations carried out by Bord na Móna Technical Services are presented as follows;

Table 5.1: Results of Field Measurements taken at each Monitoring Borehole.

Table 5.2: Results of Inorganic Chemical Analysis of Groundwater Samples.

Table 5.3: Results of Heavy Metal Screening of Groundwater Samples. Table 5.4: Results of Petroleum Hydrocarbon Analysis of Groundwater Samples.

Table 5.5: Results of Organic Analysis of Groundwater Samples.

TABLE 5.1: RESULTS OF FIELD MEASUREMENTS TAKEN AT EACH MONITORING BOREHOLE

Borehole ID Elevation of top of well

(mOD)

Static Water Level

(mbpl) Note 1

Elevation of static

water level (mOD)

Recharge rate cm/s

Temp.(oC)

MW-1 63.11 3.05 60.06 1cm/ 2sec 14.4

MW-2 NA 1.93 - 1cm/ 2sec 14.6

MW-3 Note 2 61.695 1.65 60.045 1cm/ 10sec 14.1

MW-4 Note 2 64.161 2.77 61.391 1cm/ 10sec 14.6

MW-5 62.241 2.80 59.441 1cm/ 5sec 12.7

MW-6 61.975 2.62 59.355 1cm/ 3sec 14.7

Note 1: mbpl – meters below pipe level. Note 2: Wells were purged and left to recharge several times before a sample was taken as the recharge

rate was very slow.



TABLE 5.2 RESULTS OF INORGANIC CHEMICAL ANALYSIS OF GROUNDWATER SAMPLES

Borehole Identification MW1 MW2 MW3 MW4 MW5 MW6 Parameter

Upgradient

Down gradient

Upgradient

Upgradient

Down gradient

Down gradient

Guideline Threshold Values Note1

pH (pH units) 7.5 7.5 7.7 7.9 7.4 7.6 6.5-9.5

Alkalinity(mg/l) 378 320 294 324 237 334 -Conductivity

(µS/cm) 736 1089 850 798 813 887 800-1875

COD (mg/l) <10 15 15 21 21 19 -

Calcium (mg/l) 192 1190 1899 1602 932 207 200 Note 2 Magnesium

(mg/l) 28 30 29 37 68 20 50 Note 2

Potassium (mg/l) 1.8 1.3 1.3 4.2 0.5 1.5 5 Note 2

Sodium (mg/l) 23 9.5 8.8 10 8.4 17 150

Sulphate (mg/l) 33.8 284.27 182 14.48 203.78 152.14 187.5

Chloride (mg/l) 10.91 9.43 10.88 8.1 17.93 14.9 24 – 187.5

Nitrate (mg/l) <0.05 0.09 <0.05 <0.05 <0.05 <0.05 8.47*

Note: Note 1 : GTV = Groundwater Threshold Values refers to "European Communities Environmental

Objectives (Groundwater) Regulations, 2010 (S.I. No. 9 of 2010)". "Threshold Values" have been established for pollutants that are causing a risk to groundwater bodies. Exceedance of a relevant threshold value at a representative monitoring point triggers further investigation to confirm whether the criteria for poor groundwater chemical status are being met.

Note 2: Guide Values refers to EPA Guideline Values for the Protection of Groundwater in Ireland, IGV =

Interim Guideline Value. Note these standards are presented for guideline purposes only, therefore, due care should be exercised in cross-referencing these standards with the groundwater results obtained.

< = Less than laboratory limit of detection. * = Converted GTV for Nitrate as N mg/l.

Results highlighted in bold represent results in exceedence of their respective GTV’s / IGV’s



TABLE 5.3 RESULTS OF HEAVY METAL SCREENING OF GROUNDWATER SAMPLES


Up gradient

Down gradient

Up gradient

Up gradient

Down gradient

Down gradient

Guideline Threshold Values Note1

Nickel (µg/l) 5 18 38 243 17 4 15

Iron (mg/l) 3 1.6 2.8 25 50 0.5 0.2 Note 2 Manganese

(µg/l) 1563 17070 15990 30230 3738 3044 50 Note 2

Chromium (µg/l) <2 4 2 <2 6 <2 37.5

Copper(µg/l) 10 23 2 <2 14 4 1500

Tin (µg/l) <2 <2 <2 <2 <2 <2 -

Zinc (µg/l) 30 63 43 68 143 30 100 Note 2

Cadmium (µg/l) <2 13 26 8 3 <2 3.75

Arsenic (µg/l) 41 4 5 6 <2 <2 7.5 Aluminium

(µg/l) 507 4125 597 266 1115 306 150

Barium (µg/l) 125 424 454 2969 181 121 100 Note 2 Antimony

(µg/l) <2 <2 <2 <2 <2 <2 -

Selenium (µg/l) 3 16 5 <2 7 <2 -

Cobalt (µg/l) 2 7 13 51 3 <2 -

Silver (µg/l) <2 <2 <2 <2 <2 <2 -

Berylium (µg/l) <2 <2 <2 <2 <2 <2 -

Lead (µg/l) 7 17 <2 <2 12 <2 18.75

Boron (µg/l) 65 38 47 57 38 46 750

Mercury (µg/l) <1 <1 <1 <1 <1 <1 0.75 Note:

Note 1 : GTV = Groundwater Threshold Values refers to "European Communities Environmental Objectives (Groundwater) Regulations, 2010 (S.I. No. 9 of 2010)". "Threshold Values" have been established for pollutants that are causing a risk to groundwater bodies. Exceedance of a relevant threshold value at a representative monitoring point triggers further investigation to confirm whether the criteria for poor groundwater chemical status are being met.

Note 2: Guide Values refers to EPA Guideline Values for the Protection of Groundwater in Ireland, IGV =


< = Less than laboratory limit of detection. * = Converted Interim Guideline Values for Ammonia as N mg/l, Nitrate as N mg/l and Nitrite as N mg/l. Results highlighted in bold represent results in exceedence of their respective GTV’s / IGV’s



TABLE 5.4: RESULTS FOR TOTAL PERTOLEUM HYDROCARBONS

Borehole Identification MW1 MW2 MW3 MW4 MW5 MW6 Parameter Note 1

Up gradient

Down gradient

Up gradient

Up gradient

Down gradient

Down gradient

Interim Guideline Values Note 2

C5-C6 Aliphatic(µg/l) <5 <5 <5 <5 <5 <5 10µg/l C6-C8 Aliphatic (µg/l) <5 <5 <5 <5 <5 <5 10µg/l

C8-C10 Aliphatic (µg/l) <5 <5 <5 <5 <5 <5 10µg/l C10-C12 Aliphatic (µg/l) <5 <5 <5 <5 <5 <5 10µg/l C12-C16 Aliphatic (µg/l) <10 <10 <10 <10 <10 <10 10µg/l C16-C21 Aliphatic (µg/l) <10 <10 <10 <10 <10 <10 10µg/l C21-C35 Aliphatic (µg/l) <10 <10 <10 <10 <10 <10 10µg/l

Total Aliphatics (µg/l) <10 <10 <10 <10 <10 <10 10µg/l C6-C7 Aromatic (µg/l) <5 <5 <5 <5 <5 <5 10µg/l C7-C8 Aromatic (µg/l) <5 <5 <5 <5 <5 <5 10µg/l

C8-C10 Aromatic (µg/l) <5 <5 <5 <5 <5 <5 10µg/l C10-C12 Aromatic (µg/l) <5 <5 <5 <5 <5 <5 10µg/l C12-C16 Aromatic (µg/l) <10 <10 <10 <10 <10 <10 10µg/l C16-C21 Aromatic (µg/l) <10 <10 <10 <10 <10 <10 10µg/l C21-C35 Aromatic (µg/l) <10 <10 <10 <10 <10 <10 10µg/l

Total Aromatics (µg/l) <10 <10 <10 <10 <10 <10 10µg/l TPH (µg/l) <5 <5 <5 <5 <5 <5 10µg/l

MBTE (µg/l) <5 <5 <5 <5 <5 <5 10µg/l Benzene (µg/l) <5 <5 <5 <5 <5 <5 10µg/l Toluene (µg/l) <5 <5 <5 <5 <5 <5 10µg/l

Ethylbenzene (µg/l) <5 <5 <5 <5 <5 <5 10µg/l Xylene (µg/l) <10 <10 <10 <10 <10 <10 10µg/l

Note 1; Analysis of hydrocarbons was subcontracted. Note 2: Guide Values refers to EPA Guideline Values for the Protection of Groundwater in Ireland, IGV =


< = Less than laboratory limit of detection.



TABLE 5.4: RESULTS OF ORGANIC ANALYSIS OF GROUNDWATER SAMPLES


Up gradient

Down gradient

Up gradient

Up gradient

Down gradient

Down gradient

Guideline Threshold

Values

USEPA 524.2 (µg/l)Note 1 <10 <10 <10 <10 <10 <10 -

Methanol (mg/l) <0.5 <0.5 <0.5 <0.5 <0.5 <0.5 -

Ethanol (mg/l) <0.5 <0.5 <0.5 <0.5 <0.5 <0.5 - Acetonitrile

(mg/l) <0.5 <0.5 <0.5 <0.5 <0.5 <0.5 -

Acetone (mg/l) <0.5 <0.5 <0.5 <0.5 <0.5 <0.5 -

IPA (mg/l) <0.5 <0.5 <0.5 <0.5 <0.5 <0.5 - Note 1: No compounds listed in this method (See Appendix 2) were detected above 10µg/l



6.0 DISCUSSION

Reference is made throughout a number of sections in the discussion of this report to the EPA Interim Guideline Values IGV’s and Guideline Threshold Values GTV’s. IGV’s are set out in the Interim Report “Towards Setting Guideline Values for the Protection of Groundwater in Ireland” 2004. GTV’s are set out in the Report “European Communities Environmental Objectives (Groundwater) Regulations 2010 (S.I. N o. 9 of 2010). Any parameters which exceed their respective guideline values are compared to the previous monitoring event in December 2008 (See URS Report - 49341670). Inorganics The results or in-organic chemical analysis are presented in Table 5.2. The IGV for Calcium (200 mg/l) was exceeded at 5 out of the 6 monitoring locations, namely; MW2, MW3, MW4, MW5 and MW6. This represents an improvement on the 2008 monitoring event when all 6 boreholes exceeded the EPA IGV for calcium. When comparing the Calcium concentrations to the 2008 results; MW1 (348→192 mg/l) and MW6 (248→207 mg/l) show a reduction. The remaining monitoring wells however show a notable increase, namely; MW2 (351→1190 mg/l), MW-3 (738→1899 mg/l), MW4 (1290→1602 mg/l) and MW5 (678→932 mg/l). It is worth noting however that the highest Calcium concentrations are recorded in wells up-gradient (MW3 and MW4) of the Mallinckrodt facility. This would suggest that activity within the facility is not responsible for elevated levels of Calcium down-gradient of the facility. The magnesium concentration at MW5 (68mg/l) exceeds the EPA IGV (50 mg/l). The sulphate concentration at locations MW2 (156→248.27mg/l) and MW5 (85→203.78mg/l) show considerable increase compared to the December 2008 monitoring event and now exceed the GTV (187.5 mg/l). At MW3, a concentration of 182 mg/l was detected, which shows that a high concentration of sulphate exists up-gradient of the site. All remaining inorganic parameter results (See Table 5.2) were within their respective EPA guideline values (IGV’s/GTV’s). Heavy Metals The results or heavy metals analysis are presented in Table 5.3. In 2008 the Nickel concentrations ranged from 60.9→400 mg/l. The results of the 2010 monitoring event display a significant reduction in Nickel concentration (5→243 mg/l), however 5 out of the 6 monitoring locations still exceed their respective limit of 15 µg/l.



Iron concentrations ranged from 0.5 to 50 mg/l, exceeding the EPA IGV (0.2 mg/l) for all locations monitored. Manganese results ranged from 1563→30,230 µg/l. As per the 2008 monitoring event, manganese concentration at each monitoring location remains well above the EPA IGV (50µg/l). As the highest manganese concentration was detected up-gradient of the facility at MW4 (30,230 µg/l), it is reasonable to suggest that activity within the Mallinckrodt facility are not responsible for elevated levels of Manganese. High levels of manganese in water do not pose any threat to the consumer, but may lead to an undesirable taste. The Zinc concentration at MW5 (143mg/l) exceeds the EPA IGV (100 mg/l). This represents a significant improvement compared to the 2008 monitoring event when all boreholes monitored exceeded the EPA IGV for zinc, with results ranging from 110 to 420 µg/l. Cadmium results ranged from below the laboratory limit of detection at locations MW1 and MW6 to 26 mg/l at MW6, with 3 out of the 6 samples exceeding the EPA GTV (3.75 µg/l). This represents a significant improvement compared to the 2008 monitoring event when results were considerably higher (4.1→32.5µg/l), and exceeded the GTV at all locations. Monitoring location MW1 which is up-gradient of the Mallinckrodt facility exceeded the EPA GTV for Arsenic (7.5 µg/l) with a concentration of 41µg/l. All remaining locations were below the EPA GTV. This represents a significant improvement compared to the 2008 monitoring event when results were considerably higher (6→124µg/l). The concentration of aluminium is above the EPA GTV (150 µg/l) at all monitoring locations, with results ranging from 266 µg/l at MW4 µg/l to 4125 at MW2. The concentration of barium is above the EPA IGV (100 µg/l) at all monitoring locations, with results ranging from 121 µg/l at down-gradient location MW6 to 2969 µg/l at up-gradient location MW4. The evidence would suggest that the Mallinckrodt facility is not responsible for elevated levels of barium. Volatile Organic Compounds (VOC) The results or VOC analysis are presented in Table 5.4. No VOC’s were detected for the 2010 monitoring event. This represents an improvement compared to the 2008 monitoring event when the following parameters were detected at MW1; 1,3,5-trimethylbenzene (1.1 µg/l), 1,2,4-trimethylbenzene (3.5 µg/l) and sec-butylbenzene (1.1 µg/l).



Hydrocarbons The results or Total Particulate Hydrocarbon (TPH) analysis are presented in Table 5.5. TPH parameters were not detected above their respective laboratory limits of detection for any of the boreholes sampled. This represents a significant improvement, as various TPH parameters were detected for the December 2008 monitoring event.



APPENDIX 1

DRAWING ILLUSTRATING GROUNDWATER FLOW DIRECTION AND MONITORING LOCATIONS AT THE MALLINCKRODT FACILITY


Bord na Móna, Technical Services Page 20October 10



APPENDIX 2

USEPA METHOD 524.2 COMPOUND LISTING



USEPA Method 524.2 Compound List

Dichlorodifluoromethane Chloromethane Vinyl chloride Bromomethane Chloroethane Trichlorofluoromethane 1,1-Dichloroethene Dichloromethane trans-1,2-Dichloroethene 1,1-Dichloroethane cis-1,2-Dichloroethene 2,2-Dichloropropane Bromochloromethane Chloroform 1,1,1-Trichloroethane Carbon tetrachloride 1,1-Dichloropropene Benzene 1,2-Dichloroethane Trichloroethene 1,2-Dichloropropane Dibromomethane Bromodichloromethane cis-1,3-Dichloropropene Toluene trans-1,3-Dichloropropene 1,1,2-Trichloroethane Tetrachloroethene 1,3-Dichloropropane Dibromochloromethane 1,2-Dibromoethane Chlorobenzene Ethylbenzene p-Xylene m-Xylene Styrene o-Xylene Isopropylbenzene Bromoform 1,2,3-Trichloropropane Bromobenzene 2-Chlorotoluene n-propylbenzene 4-Chlorotoluene 1,3,5-Trimethylbenzene 1,2,4-Trimethylbenzene tert-Butylbenzene 1,3-Dichlorobenzene sec-Butylbenzene 1,2-Dichlorobenzene n-Butylbenzene 1,2,4-Trichlorobenzene 1,2-Dibromo-3-chloropropane Naphthalene Hexachlorobutadiene 1,1,1,2–Tetrachloroethane 1,2,3 Trichlorobenzene 1,4–Dichlorobenzene

4-Isopropyltoluene


APPENDIX 7

BUND AND SUMP REPORT 2010


COVIDIEN PHARMACEUTICALS DUBLIN

BUND AND SUMP REPORT 2010 Licensee: Mallinckrodt Medical Imaging Ireland Damastown Industrial Estate Mulhuddart Dublin 15 Licence No: P0050-02


1. INTRODUCTION AND OBJECTIVES Bund and sump integrity testing was carried out at Covidien Pharmaceuticals Dublin between July and October 2010.

In total thirty-nine bunds and thirteen sumps were included in the assessment as per the conditions of Integrated Pollution Control (IPC) license no. P0050-02.

The objective of this project was to assess the integrity and water tightness of bunds and sumps based on a detailed visual inspection/survey and hydrostatic testing.

2. SCOPE OF WORKS

The scope of works employed during the testing program was based on IPC guidance note Environmental Protection Agency (EPA) 2004, “Environmental Protection Agency: IPC Guidance Note on Storage and Transfer of Materials for Scheduled Activities”.

Bund testing at Covidien Pharmaceuticals Dublin consisted of:

• Preliminary inspection and structural survey.

• Identification of bunds that required hydrostatic testing with regard to:

− Necessity;

− Practicability; and

− Safety.

• Controlled, supervised hydrostatic testing of identified bunds.

• Reporting of survey and integrity testing.

3. METHODOLOGY

The methodology employed for the surveying and hydrostatic testing of bund and sump structures in this report was derived with reference to the EPA IPC guidance document note (EPA 2004) and British Standard (BS 8007): 1987 Code of Practice for Design of Concrete Structures for Storage of Aqueous Liquids (BS 8007), (as referenced in the EPA 2004).

3.1 Preliminary Inspection and Structural Survey

A preliminary condition inspection was carried out by the Project Engineer and Environmental Engineer of Covidien Pharmaceuticals Dublin to determine the current condition of the bunds; and practicability and safety of integrity testing bunds at the site.

ORS Consulting Engineers were contracted as certified engineers to conduct a structural survey of the bunds at Covidien Pharmaceuticals Dublin. A certified structural engineer conducted a structural survey of 35 bunds to determine whether it was necessary, practicable and safe to hydrostatically test each. The structural survey report is presented in Appendix B.


The four new bunds were not included in the assessment, and it was not operationally possible to inspect the sumps during this inspection due to production requirements.

3.2 Retention Capacity of Bunds

EPA guidance (EPA, 2004) states that the retention capacity of bunded structures provided locally or remotely should not be less than the greater of the following:

− 110% of the capacity of the largest tank or drum within the bunded area,

− 25% of the volume of the substance which could be stored within the bunded area

Covidien provided information on the retention capacity of the bunded structures and the volume of the largest tank contained within them.

3.3 Selection of Bunds and Sumps for Hydrostatic Testing

The selection of bunds for hydrostatic testing was based on the observations and recommendations of the structural survey, the practicability of testing the bund/sump in an operational facility and health and safety considerations.

The purpose of the hydrostatic test was to assess bund/sump integrity. According to EPA guidance (EPA, 2004):

“Where a bund has been deemed safe and practicable to test, a prescribed test method shall be used which shall be appropriate to the nature of the containment situation and the material of construction of the bund. In all cases the test procedure should be specified, supervised and reported on by a suitably qualified person”.

3.4 Hydrostatic Testing - Methodology

Bunds and sumps were filled with water to a predetermined level and left to stabilise for 24 hours. The depth of water in each bund was then measured by the junior EHS engineer and the bund/sump was isolated for between 24 and 48 hours depending on the practicability of isolating the particular bund/sump. After the test period the depth of water in the bund was measured and the two measurements were compared.

In addition, a control vessel was also filled with water and placed in the vicinity of the bunds/sumps being tested for the duration of the test. This was used to determine the influence of evaporation and/or rainfall. It was measured at the beginning and end of the test and the difference recorded (if any) was used to correct the measurements from the bunds/sumps.

Determining whether a bund/sump has passed or failed the integrity test was based on BS8007 (as referenced in EPA, 2004), which recommends an ideal test period of 7 days and states:

“…the total permissible drop in level, after allowing for evaporation and rainfall, should not exceed 1/500th of the average water depth of the full tank, 10mm or another specified amount”


Most bunds and sumps were tested over a period of 2 days therefore a nominal value of +/- 5mm (0.5 times the 10mm stipulated in BS8007) was considered appropriate and conservative to determine a pass or fail during hydrostatic testing. Values of <5mm were considered insignificant. Values of greater than 5mm were considered significant and could potentially indicate that the structure was not watertight.

3.5 Changes since Last Reporting Period

Since the last reporting period under the IPPC conditions, the following issues noted below were identified and rectified.

During 2009 the Company verified retention capacity of 5 bunds identified and based on this information, all 5 are now considered to be suitable for retention. These are B15, B22, B29, B30 and B34

Bunds B10, B11, B12, B21, S1, S5 and S11 were bunds and sumps that passed on visual inspection previously and following work, these were retested by the Company in 2009 and were considered to have passed based on hydrostatic testing.

B17, B18 and B32 were reassigned for visual inspection by a structural engineer alone as they are hard standing areas.

The following 3 bunds were considered to have passed the assessment of integrity and water tightness based on detailed visual inspection/survey and hydrostatic testing but at the time of assessment in 2008 had insufficient bund retention volume. These bunds were replaced in 2008- B23, B27, B28, and B23 has since been removed.

In addition the following bunds were replaced by the Company in 2008- B17 (Drip Trays) & B18 (Drip Trays) were removed with the hard standing and chemstore remaining; B24, B25 and B26 were replaced for utilities boiler dosing chemicals. B22 was decommissioned.

Concrete repairs were completed by the Company on the following bunds in late 2008- B11, B12, B17, B18 and B19

Cleaning and visual inspection was conducted on the following sump in 2009- S7

Concrete repairs and visual inspections were completed on the following sumps in 2009- S4, S2.

The following additions have been made to bunds and sumps at the site:

• A DMAc Waste tank bund which is linked to B10 and B11 – B11A

• Linked bunding for two equalisation tanks and a salt derived low strength waste water tank- B37, B38 & B39

• New ASI Extension Sump- S13

These have been designed in accordance with EPA recommended specifications.


4. RESULTS

The following sections present a summary of the results of the bund and sump surveying and hydrostatic testing (where completed).

4.1 Preliminary Inspection and Structural Surveys

The preliminary condition inspection was carried out by the Project Engineer and Environmental Engineer of Covidien Pharmaceuticals Dublin to determine the current condition of the bunds; and practicability and safety of integrity testing bunds at the site.

It was recommended that a deep clean and power washing was required to remove residual debris and detritus from the bunds in order to adequately structurally inspect the bunds.

The structural survey report completed by ORS is included in Appendix B. The following is a summary of the results.

The structural condition of all bunds and sumps was reported as “…..generally good with no considerable structural deficiencies” with the following exceptions:

All but 7 of the bunds (bunds 5, 8, 12, 13, 14, 17 & 18 and 35) surveyed were deemed readily suitable for hydrostatic testing. Of the other 7; repair of the bund lining is recommended for 5 bunds (bunds 5, 8, 12, 13 and14) and repair of drains and cracked slab areas are recommended for the other 2 bunds(bunds 17 & 18 and 35).

There was no assessment made of the new sump or four new bunds as they are certified and will be subject to assessment during the next reporting period.

Due to operational production constraints on the sumps, these were not subject to inspection by ORS. It was decided to carry out sump assessment and testing during shutdown periods and as is possible under confined space entry by maintenance engineering staff.

Please refer to Appendix C for details on Sump inspection, testing and repairs.

4.2 Retention Capacity of Bunds

Information on the retention capacity of bunds and sumps is presented in Table 1. The following is a summary of the results.

All bunds had the appropriate retention capacity based on the EPA guidelines with the exception of B29 Polymer bund. This will be upgraded in 2011. The retention of B33 under ownership of the ESB was not confirmed. This will be assured in 2011.

The following bunds were not applicable as they are not bunds per se but containment features: - B15, B17, B18, B21, B32 & B35.

B23 was not compliant in 2008 and was removed from service.


Please refer to Appendix A for full details relating to Bund Retention Volumes.

4.3 Hydrostatic Testing

Of the bunds assessed, it was found that 5 were better suited to being assessed by visual inspection and through sump inspection due to the free bund draining to those sumps below. 7 further bunds were deemed by the structural engineer not to be practicable, safe and necessary to hydrostatically test. Of these, 2 of the bunds were unsafe to test due to chemical and electrical hazards.

The following bunds were not considered practicable for hydrostatic testing:

Bund Ref Tank Bund/Sump Name Comments B5 T-940 H.S Waste Repairs required B8 T-871 MeOH Recovery Repairs required B9 T-5031 CAC Unsafe to Test. B12 SC-2011 Scrubber Repairs required

B13 TA-2021 Process Pumps under

TA-2021 Repairs required B14 TA-2048/2049 DMAC Recovery Repairs required

B17 IBCs/Drums Chemstore Hard

standing Designed to empty to sump beneath

B18 IBCs/Drums Drumstore Hard standing Designed to empty to sump beneath

B21 Charging scales Charging scales bund Designed to empty to sump beneath

B32 IBCs/Drums Hard standing Designed to empty to sump beneath

B33 N/A Transformer Restricted access to ESB only. Unsafe.

B35

Tanker Unloading

polychannel Polychannel Designed to empty to sump beneath

Of those that required repair, these were completed in 2010, hydrostatically tested and passed:

Bund Ref Tank Bund/Sump Name Comments B12 SC-2011 Scrubber Repaired and Passed

B13 TA-2021 Process Pumps under

TA-2021 Repaired and Passed B14 TA-2048/2049 DMAC Recovery Repaired and Passed


It was not practicable to test sumps hydrostatically due to operational production constraints and lack of ability to control inputs safely. Confined space entry inspections continue to be performed by Covidien during shutdown periods in lieu of the hydrostatic test.

Three confined space entries were carried out on sumps in December 2009 for S7, S10 and S12

The following two bunds were considered unsafe to test:

• B9 (CAC): This bund was considered unsafe for hydrostatic testing as the contents of the tank within the bund react with water.

• B33 (Transformer): This bund was considered unsafe for hydrostatic testing due to presence of electrical infrastructure within the bund.


Appendix A

Bund Retention Volumes


FILE 6 APPEN 7 BUND TO BUND APPENDIX

Table 1 Bund Retention Volumes Covidien Pharmaceuticals Dublin 2010

Ref

Bund/Sump Name Location

Bund Retention Volume (L)

Primary Vessel Storage Volume(L)

110% volume of primary vessel

Pass/Fail

B1 MeOH Tank Farm 34453 30000 33000 Pass

B2 Waste MeOH Tank Farm 35074 22300 24530 Pass

B3 NaOH Tank Farm 33695 27500 30250 Pass

B4 HCl Tank Farm 35700 30200 33220 Pass

B5 H.S Waste Rear of Process Building 12960 7500 8250 Pass

B6 L.S Waste West Utilities Building 12807 5765 6341.5 Pass

B7 MeOH Recovery

Rear West Process Building 20540 4000 4400 Pass

B8 MeOH Recovery

Rear West Process Building 19430 500 550 Pass

B9 CAC Tank Farm 35700 30000 33000 Pass

B10 DMAC (virgin) Tank Farm 103750 37850 41635 Pass

B11 DMAC Storage Tank Farm 103750 37850 41635

Pass

B11A DMAC waste Tank Farm 103750 63000 69300

Pass

B12 Scrubber Rear of Process Building 7735 4000 4400 Pass

B13 Process Pumps under TA-2021

Rear Process Building 18616 8000 8800

Pass

B14 DMAC Recovery

Rear of Process Building 16836 7400 8140 Pass

B15 Scrubber West Process building 19300 4000 4400

Pass

B16 R.O Make-up Tanks

West Process Building 35200 30000 33000 Pass

B17 Chemstore Hardstanding Drumstore Area

Drainage to sump beneath.

B18 Drumstore Hardstanding Drumstore Area

Drainage to sump beneath.



Ref

Bund/Sump Name Location

Bund Retention Volume (L)

Primary Vessel Storage Volume(L)

110% volume of primary vessel

Pass/Fail

B19 Diesel Generator Bund

North of Warehouse 756 100 110

Pass

B20 Portable Bund

CE Drum charging area 200L 25L 30L Pass

B21 Charging scales bund CE Drum charging Drainage to sump beneath.

-

B22 Two small bunds.

Portable Bund- 2 IBCs 250 200 275 Pass

B23 Polymer Feed Pump Polymer room Removed N/A

B24 Utilities Building

Fixed Bund (Boiler Chemical Dosing) 412.5 375 412.5

Pass



Pass



Pass

B27 Utilities Building NaOH Day Tank 555 379 416.9 Pass

B28 Utilities Building HCl Day Tank 555 379 416.9 Pass

B29 Polymer Polymer Room 1445 2000 2200 Fail

B30 Foamatrol Polymer Room 750 500 550 Pass

B31 Temp Bund Outside the aeration blowers 10880 1200 1320 Pass

B32 Hardstanding Drumstore Area Drainage to sump beneath. -

B33 Transformer Outside Maintenance

No access. ESB only

No confirmation

No confirmation

-

B34 TOC Bund Drumstore Area 72 N/A NA Pass

B35 Polychannel Tank farm Drainage to sump beneath. -

B37 Equalisation Tank 1

Wastewater Treatment 750000 25000 44000

Pass

B38 Equalisation Tank 2


Pass

B39 Low Strength Waste Tank


Pass



Appendix B

ORS Structural Survey

ORS Consulting Engineers Condition Survey of bunds, Covidien, Mulhuddart, Dublin 15.

Project No: 101_210

SOP-OP-006 VERIFY PRINTED COPY IS THE CORRECT REVISION BEFORE USE

REV 1 Printed Date: 14/10/2010

REV DATE: 8/05/08

Structural Condition Survey

of Bunds at Covidien,

Damastown, Mulhuddart,

Dublin 15.

September 2010

Client Revision Date Compiled Checked Approved

Meabh O’ Loughlin, A 14/10/10 BB FMS BB

Covidien, B 14/10/10 BB FMS BB

Damastown,

Mulhuddart,

Dublin 15.


Project No: 101_210



REV DATE: 8/05/08

Index

1.0 INTRODUCTION

2.0 CONCLUSIONS

3.0 OBSERVATIONS AND RECOMMENDATIONS

Appendix A Photographs


Project No: 101_210



REV DATE: 8/05/08

1.0 INTRODUCTION

i) ORS Consulting Engineers were instructed by Covidien to visually inspect

bunded areas and sumps on their behalf at Damastown, Mulhuddart.

ii) A visual inspection was carried out by Brian Broderick of ORS on Thursday

23rd September 2010.

iii) The inspection was entirely visual; no residues or finishes were removed

from walls or bases.

iv) The inspection was carried out in the order as outlined below and not in

numerical order.

v) Bunds 17 & 18 are taken as the same bund for the purposes of the survey

as they are ultimately contained within the same area.

2.0 CONCLUSIONS

i) The bund type and form of construction varied between reinforced

concrete structures, plastic bunds and steel trays. The condition of the

bunds was generally good with no considerable structural deficiencies.

ii) Different recommendations are given for the different scenarios and forms

of construction.

iii) All but 7 of the bunds (bunds 5, 8, 12, 13, 14, 17 & 18 and 35) surveyed are

deemed readily suitable for hydrostatic testing.

iv) Of the other 7; repair of the bund lining is recommended for 5 bunds

(bunds 5, 8, 12, 13 and14) and repair of drains and cracked slab areas are

recommended for the other 2(bunds 17 & 18 and 35).


Project No: 101_210



REV DATE: 8/05/08

3.0 OBSERVATIONS AND RECOMMENDATIONS

Bund no. Practicable

and Safe to

test?

Comments Necessary

to test?

Recommendations

B17 and B18

Yes Concrete slab with small

plinth wall to three sides.

Drains to sump. Many

Storage drums contained

within independent

proprietary steel

containers. Some

previous remediation to

plinth wall evident. Lining

of channel and slab

compromised in one

location. There is other

minor cracking in the slab

and plinth walls which

may not compromise

integrity.

Yes Recommend repair

and sealing of channel

lining and slab where

compromised. Not

evident from visual

inspection whether

construction designed

to BS 8007 or BS 8110.

Carry out controlled,

supervised Hydrostatic

Testing in accordance

with relevant codes,

standards & guidelines

B11a

Yes Concrete bund. Some

previous repairs to wall

visible. Lining and integrity

appear to be good

generally. There is

evidence of minor

cracking in areas but this

may not compromise

integrity of the bund.

Yes Not evident from visual

inspection whether


to BS 8007 or BS 8110.





standards & guidelines.

Care to be taken to

protect electrical

equipment during

testing.

B9

Yes Concrete Bund. An

indication of confined

space training

requirements prevented

full access to this area.

Where observed the

bund appeared to be in

good condition with no

evidence of significant

structural flaws with only

minor cracking evident in

some areas.


inspection whether


to BS 8007 or BS 8110.






Care to be taken to

protect electrical

equipment during

testing.


Project No: 101_210



REV DATE: 8/05/08


and Safe to

test?

Comments Necessary

to test?

Recommendations

B4

Yes Concrete Bund. Evidence

of previous repairs to the

bund structure. The

walkway/ladder access

to the bund was noted as

being unsteady. The lining

appears to be in good

condtion generally. The

lining was stained in

locations under pipework.


inspection whether


to BS 8007 or BS 8110.






Care to be taken to

protect electrical

equipment during

testing.

B1

Yes Concrete Bund. Evidence

of previous repairs to the

bund structure. Some

minor cracking present

but this does not

necessarily compromise

integrity. The lining

appears to be generally

ok.


inspection whether


to BS 8007 or BS 8110.






Care to be taken to

protect electrical

equipment during

testing.

B35

Yes Concrete bund

incorporating drain and

slab area, drains into

sump 5 (Not inspected).

Drain lining generally

seems ok but is ruptured

slightly in one location.

Cracking evident in slab

where dug up and

replaced previously.

Yes Recommend repair of

drain and slab area

where compromised.

Not evident from visual

inspection whether


to BS 8007 or BS 8110.






Care to be taken to

protect electrical

equipment during

testing.


Project No: 101_210



REV DATE: 8/05/08


and Safe to

test?

Comments Necessary

to test?

Recommendations

B2

Yes Concrete Bund. Lining

appears to be ok

generally. Previous repairs

and sealing visible. Minor

cracking evident but

doesn’t necessarily

compromise integrity.


inspection whether


to BS 8007 or BS 8110.






Care to be taken to

protect electrical

equipment during

testing.

B3


appears to be ok







inspection whether


to BS 8007 or BS 8110.






Care to be taken to

protect electrical

equipment during

testing.

B10


appears to be ok







inspection whether


to BS 8007 or BS 8110.






Care to be taken to

protect electrical

equipment during

testing.


Project No: 101_210



REV DATE: 8/05/08


and Safe to

test?

Comments Necessary

to test?

Recommendations

B11

Yes Concrete Bund.

Significant previous

repairs and sealing visible.

Minor cracking evident

but doesn’t necessarily



inspection whether


to BS 8007 or BS 8110.






Care to be taken to

protect electrical

equipment during

testing.

B23

Yes Plastic bund. No defects

noted.

Yes Carry out controlled,





B22

Yes Steel containment bunds. Yes Carry out controlled,





B6 Yes Concrete bund. Previous

repairs to bund visible.

Lining may be

compromised in locations

locally.


inspection whether


to BS 8007 or BS 8110.






Care to be taken to

protect electrical

equipment during

testing.

B27 and B28 Yes Concrete interlinked

bunds. Appear to be in

reasonable condition.

Residue may mask

defects on the base of

the bund and the sumps

are not visible.


inspection whether


to BS 8007 or BS 8110.






Care to be taken to

protect electrical

equipment during

testing.


Project No: 101_210



REV DATE: 8/05/08


and Safe to

test?

Comments Necessary

to test?

Recommendations

B25, B25 and B26

Yes Steel containment bunds.

No defects noted.







repairs visible. Lining

pealing in locations.

Residue may mask

defects in areas. Minor

cracking in locations but

may not affect integrity.


lining where pealed.

Not evident from visual

inspection whether


to BS 8007 or BS 8110.






Care to be taken to

protect electrical

equipment during

testing.


repairs visible. Lining worn

off, possibly by chemicals,

in locations. Residue may

mask defects in areas.

Minor cracking in

locations but may not

affect integrity.


lining where worn. Not

evident from visual

inspection whether


to BS 8007 or BS 8110.






Care to be taken to

protect electrical

equipment during

testing.


Project No: 101_210



REV DATE: 8/05/08


and Safe to

test?

Comments Necessary

to test?

Recommendations


repairs visible. Minor

cracking in locations but

may not affect integrity.

The bund lining is worn off

in patches, possibly by

chemicals.



evident from visual

inspection whether


to BS 8007 or BS 8110.






Care to be taken to

protect electrical

equipment during

testing.

B5 Yes Concrete bund. Good

condition generally.

Lining observed to be

wearing off in patches.

Minor cracking in

locations but not

structurally significant.

Minor previous repairs are

visible.



evident from visual

inspection whether


to BS 8007 or BS 8110.






Care to be taken to

protect electrical

equipment during

testing.

B8 Yes Concrete bund.

Chemicals appear to be

breaking down concrete

slab in localised areas.

Parches worn off lining in

localised areas. Previous

repairs to bund are

visible.


lining where worn,

preferably with a lining

that will protect the

concrete slab from

chemicals. Not evident

from visual inspection

whether construction

designed to BS 8007 or

BS 8110. Carry out

controlled, supervised

Hydrostatic Testing in

accordance with

relevant codes,


Care to be taken to

protect electrical

equipment during

testing.


Project No: 101_210



REV DATE: 8/05/08


and Safe to

test?

Comments Necessary

to test?

Recommendations

B7 Yes Concrete bund

comprising 2 sections.

Previous repairs to bund

visible. The lining has

been patched in areas

previously. Minor cracking

is evident but this may not

affect the integrity of the

bund.


inspection whether


to BS 8007 or BS 8110.






Care to be taken to

protect electrical

equipment during

testing.

B20

Yes Steel containment bund

draining into bund 21. No

defects noted. Dirt and

leaves may mask defects.






Judgement to be

made by URS on codes

and standards to be

used.

B21 Yes Concrete slab and bund

draining to sump (not

inspected). Minor

cracking visible in

locations but this may not

affect the integrity of the

slab or bund.


inspection whether


to BS 8007 or BS 8110.






Care to be taken to

protect electrical

equipment during

testing.

B15

Yes Concrete bund in good

condition generally.

Minor cracking is evident

in location but this may

not affect the integrity of

the bund. The bund walls

appear to have been

raised in the past. The

lining of the bund is in

good condition generally.


inspection whether


to BS 8007 or BS 8110.






Care to be taken to

protect electrical

equipment during

testing.


Project No: 101_210



REV DATE: 8/05/08


and Safe to

test?

Comments Necessary

to test?

Recommendations

B16

Yes Concrete bund. Minor

cracking visible in

locations but may not

affect integrity of the

bund. No internal bund

lining evident but lining

covers some walls along

perimeter of the main

building. Generally in

good condition.


inspection whether


to BS 8007 or BS 8110.






Care to be taken to

protect electrical

equipment during

testing.

B34 Yes Steel containment bunds.

No defects noted but

residue may mask some

defects.






Judgement to be

made by URS on codes

and standards to be

used.


Project No: 101_210



REV DATE: 8/05/08

Appendix A

Photographs

Appendix C

Sump Inspection, Testing and Repair Details

Covidien Pharmaceuticals Dublin AER 2010 Table 2 Sump Details Covidien Pharmaceuticals Dublin 2010

Sump Description location Status

S1 Lab East process building Not possible to control infilling. Confined Space Entry only

S2 Process Sump West of process building

Repair to inner lining in June 2009

S3 ASI process Sump ASI Lower Not possible to control infilling. Confined Space Entry only

S4 Utilities sump Boiler house Repair to inner lining in June 2009

S5 Tank farm Tank farm Not possible to control infilling. Confined Space Entry only

S6 Warehouse NE process building Not possible to control infilling. Confined Space Entry only

S7 Confluence tank WWTP Inspection complete Dec 09

S8 Oil/water interceptor South utilities building

Not possible to control infilling. Confined Space Entry only

S9 CE sump West process building


S10 Diverter valve( 2 chambers) Front lawn Inspection complete Dec 09

S11 Scrubber Sump ( ref B 15)

West process building


S12 Weir to pond ( 2 chambers) Front lawn Inspection complete Oct 09

S13 ASI Extension Rear Warehouse New


APPENDIX 8

CRAMP – APRIL 2007.


APPENDIX 9

SUMMARY OF ENVIRONMENTAL LIABILITY RISK ASSESSMENT –

APRIL 2007


APPENDIX 10

NOISE REPORT 2010

Covidien Ireland Ltd IE0310297-22-RP-0001 Issue A Noise Monitoring 17 September 2010

IE0310297-22-RP-0001_A_01.DOC Page 2 of 20

CONTENTS

1. INTRODUCTION 3

1.1 Scope 3

2. NOISE SURVEY 4

2.1 Noise Monitoring Locations 4

2.2 Noise Monitoring 4

2.3 Noise Guidance & Standards 4

2.4 Equipment 5

2.5 Weather Conditions 5

2.6 Measurement Parameters 5

3. NOISE MONITORING RESULTS 7

4. DISCUSSION 11

4.1 Monitoring Location NSL 1 11

4.2 Monitoring Location N1 11

4.3 Monitoring Location N2 12

4.4 Monitoring location N3 12

4.5 Monitoring location N4 12

4.6 Tonal Analysis 13

5. CONCLUSION 14

APPENDIX A 16

Drawing Showing Locations of Noise Monitoring points 16

APPENDIX B 18

1/3 Octave Spectrum Graph of Noise Sources for Identification of Tonal Qualities 18


IE0310297-22-RP-0001_A_01.DOC Page 3 of 20

1. INTRODUCTION

PM Group (PM) was requested by Meabh O’Loughlin, EHS Engineer of Covidien to carry out an Environmental Noise Survey in compliance with Schedule 8 of the site’s IPPC Licence as follows:

The noise survey is undertaken to assess the site compliance with Condition 8.2 and 8.3 of the IPPC licence.

Condition 8.2 and 8.3 state:

‘Activities on-site shall not give rise to noise levels off-site, at noise sensitive locations, which exceed the following sound pressure limits (Leq, 15 min) subject to Condition 3 of this licence:

8.2.1 Daytime: 55 dB(A;,

8.2.2 Night-time: 45 dB(A).

There shall be no clearly audible tonal component or impulsive component in the noise emission from the activity at any noise sensitive location.’

Condition 3.4 Noise also states the following;

“3.4.1 Noise from the activity shall not give rise to sound pressure levels (Leq, 15) measured at noise sensitive locations which exceed the limit value(s) by greater than 2 dB(A).”

1.1 Scope

The scope of the work carried out is as follows:

• Daytime noise monitoring at 4 boundary locations and 1 sensitive location over a 30 minute period

• Night time noise monitoring at 4 boundary locations and 1 sensitive location over a 15 minute period

• 1/3rd octave band analysis at each location for the day and night time scenarios

The noise survey was carried out on 1st September 2010 in accordance with EPA Environmental Noise Survey Guidance Document (2003). This report details the noise levels recorded during the survey. A drawing showing the location of monitoring locations is included in Appendix A.


IE0310297-22-RP-0001_A_01.DOC Page 4 of 20

2. NOISE SURVEY

2.1 Noise Monitoring Locations

The noise monitoring study was carried out by PM on the 1st September 2010. Readings were taken at five different locations around the Covidien site with the Covidien facility visible from all locations. See Table 2.1 below for noise monitoring location descriptions & Figure 1 in Appendix A. The monitoring locations were selected during the IPPC Licence Application.

Table 2.1: Description of Noise Monitoring Points

Noise Monitoring Points Description

NSL 1 Located to the Southeast of the facility between the Astellas boundary and the Covidien boundary along Damastown Drive

N1 Located to the west of the facility along the western field boundary

N2 Located to the north of the facility at facility’s northern boundary corner

N3 Located to the south of the within the facility’s boundary near local roundabout

N4 Located to the east of the facility within the facility’s eastern boundary corner

2.2 Noise Monitoring

During the survey, the noise levels were recorded over 30 minute measurement periods for daytime monitoring and 15 minute measurement periods for night time monitoring. The measurements were taken at least 3.5 m from reflecting surfaces and the measurement height was 1.2 m above ground level.

The following parameters were recorded at each location, along with details concerning the weather and noise sources identified:

• LAeq

• LAMax

• LA10

• LA90

Refer to Section 2.6 for a description of the noise terminology used in this report.

2.3 Noise Guidance & Standards

The noise monitoring was conducted in accordance with the following guidance:

• EPA Environmental Noise Survey Guidance Document (2003)

• International Standard ISO 1996-1:2003 - Acoustics – Description and Measurement of Environmental Noise (2003)


IE0310297-22-RP-0001_A_01.DOC Page 5 of 20

2.4 Equipment

The following noise measurement equipment was used to conduct the noise monitoring:

• Bruel and Kjaer 2260 Sound Level Meter1 c/w Bruel and Kjaer type 4189 Microphone

• Bruel and Kjaer Type 4231 Calibrator. The Sound Level Meter was calibrated before and after the survey using the calibrator.

• Tripod

The Sound Level Meter and calibrator were last calibrated by the manufacturers Brüel & Kjaer UK Ltd, on 13/08/10 in accordance with procedure documented in BS7580:Part 1:1997.

2.5 Weather Conditions

Day time 01 September 2010: Dry, slight breeze, clear sky

Night time 01 September 2010: Dry, no breeze, clear sky

2.6 Measurement Parameters

Noise is measured in terms of decibels (dB). The various measurement parameters and noise terminology are defined below.

• Decibel (dB)

Decibel (dB) is the standard unit for expressing the noise level (sound pressure level). It is calculated as a logarithm of the intensity of sound. It is derived from the logarithm of the ratio between the value of a quantity and a

reference quantity. For sound pressure level the reference quantity is 20µPa which is the threshold of normal hearing and equates to 0dB. At the upper end of the scale 140dB is the threshold of pain.

• A-weighted Decibel (dBA)

Decibels measured on a sound level meter incorporating a frequency weighting (A weighting) which differentiates between sound of different frequency (pitch) in a similar way to the human ear. This takes account of the fact that the human ear has different sensitivities to sound at different frequencies.

• Leq

The equivalent continuous sound level – the sound pressure level of a steady sound having the same energy as a fluctuating sound over a specified measuring period. It can be considered similar to an average level. The LAeq value is the A-weighted Leq.

1 The Bruel and Kjaer 2260 Sound Level Meter is a Type 1 meter


IE0310297-22-RP-0001_A_01.DOC Page 6 of 20

• LA90 and LA10 Values

The LA90 and LA10 values represent the A-weighted sound pressure levels exceeded for a percentage of the instrument measuring time. The LA90 represents the sound pressure level exceeded for 90% of the monitoring period and is a good indicator of the background noise level excluding peak noise events. LA10 indicates the sound pressure level exceeded for 10% of the monitoring period and is a good parameter for expressing event noise such as passing traffic.

• LAr T

The equivalent continuous A- weighted sound pressure level during a specified time interval, T, plus specified adjustments for tonal character and impulsiveness of the sound.

• Tonal Noise

One-third octave band tonal analysis involves the calculation of an averaged, unweighted noise level to represent the frequencies within each third of an octave. These noise levels are then compared with the noise levels calculated for the adjacent one-third octave bands. If a noise level is at least 5dB higher than the noise levels representing the adjacent bands then it is considered tonal, since it is significantly louder than noise levels at similar frequencies.

• Impulsive Noise

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

Covidien Ireland Ltd IE0310297-22-RP-0001Issue A Noise Monitoring 17 September 2010

IE0310297-22-RP-0001_A_01.DOC Page 7 of 20

3. NOISE MONITORING RESULTS

The results of the Environmental Noise Monitoring for the day time and night time periods are summarised in Tables 3.1 and 3.2 below. Appendix A includes a drawing illustrating the location of each monitoring point.

Table 3.1: Environmental Noise Monitoring Results – Day Time Monitoring

Noise Measurement

Description Start Time LAeq dB(A)

LAMAX dB(A)

LA10 dB(A)

LA90 dB(A)

Audible sounds during measurement period

NSL1 Located to the Southeast of the facility between the Astellas boundary and the Covidien boundary along Damastown Drive

13:11 66 85 71 48 • Traffic along Damastown Drive (dominant noise source)

• Hum from Covidien facility

• Hum from Astellas facility

• Trees rustling in breeze

• Overhead air traffic

• Birdsong

• People walking and talking on foot path (approx 10m from noise meter)


12:25 53 66 54 51 • Traffic from the surrounding road network especially the N3 (dominant noise source)



• Clanking of steel against steel from facility scaffolding


• Birdsong

• Faint HGV noise from adjacent industrial facilities


IE0310297-22-RP-0001_A_01.DOC Page 8 of 20

Noise Measurement


LAMAX dB(A)

LA10 dB(A)

LA90 dB(A)


N2 Located to the north within facility boundary

15:36 55 63 55 54 • Constant hum from waste water treatment plant (WWTP) control building (dominant noise source


• Hum from generators beside WWTP


• Birdsong

• Short whine from adjacent industrial facilities

• Traffic in distance from surrounding road network

• Door banging at waste water station

N3 Located to the south within facility boundary

14:20 61 78 63 55 • Heavy traffic on local roundabout (dominant noise source)

• Truck entering, reversing and leaving facility



• Covidien plant slightly audible

• Car entering Covidien

N4 Located to the east within facility boundary

15.03 51 65 54 45 • Waste water treatment plant (dominant noise source)


• Traffic on Damastown Drive

• Sudden bang from truck trailer going over speed bump on entrance to IBM



IE0310297-22-RP-0001_A_01.DOC Page 9 of 20

Table 3.2: Environmental Noise Monitoring Results – Night Time Monitoring

Noise Measurement


LAMAX dB(A)

LA10 dB(A)

LA90 dB(A)


NSL1 Located to the Southeast of the facility between the Astellas boundary and the Covidien boundary along Damastown Drive

22.49 59 80 56 47 • Hum from Covidien facility (dominant noise source)

• Traffic from the surrounding road network especially the N3


• Slight hum from Astellas facility


22.22 52 59 53 49 • Traffic from the surrounding road network especially the N3 (dominant noise source)



N2 Located to the north within facility boundary

23:55 55 60 56 54 • Constant hum from waste water treatment plant (WWTP) control building (dominant noise source)


• Hum from cooling water tower system beside WWTP control building

N3 Located to the south within facility boundary

23.11 59 68 62 53 • Heavy traffic on local roundabout (dominant noise source)

• Traffic on N3

• Horn is distance

• Slight rustle of trees


• Covidien plant audible

• Car leaving Covidien facility


IE0310297-22-RP-0001_A_01.DOC Page 10 of 20

Noise Measurement


LAMAX dB(A)

LA10 dB(A)

LA90 dB(A)


N4 Located to the east within facility boundary

23.35 46 57 49 42 • Waste water treatment plant (dominant noise source)


• Traffic in distance on N3 and local road network


IE0310297-22-RP-0001_A_01.DOC Page 11 of 20

4. DISCUSSION

The environmental noise measurement results for the daytime and night-time noise monitoring periods at locations NSL1, N1 – N5 are outlined in Table 3.1 and Table 3.2. The Covidien facility was visible at all monitoring locations.

4.1 Monitoring Location NSL 1

Monitoring location NSL1 is located to the Southeast of the Covidien facility. NSL 1 is located along Damastown Drive between the Covidien and Astellas boundary.

Day Time

During the day time monitoring period, traffic along Damastown Drive was the dominant noise source. The LAeq,30 min for the day time monitoring period was 66

dB(A). The measurement LA90, obtained during the survey was 48dB(A). As this represents 90% of the monitored sound pressure level it is a good indicator of the background noise level excluding peak noise events. Background noise at NSL 1 consists of noise from the Covidien facility, Astellas facility and the constant hum of traffic from the N3. The LA,max for the monitoring period was 85 dB(A) which was the result of a bus travelling along Damastown Drive. As NSL 1 is influenced heavily from off site noises and noise emissions from the Covidien plant are considered continuous in nature the LA90 gives a more accurate measure of site noise than the LAeq. Therefore it is considered that IPPC Licence daytime noise limit of 55dBA at the NSL, resulting from the Covidien facility, is met.

Night Time

The Covidien facility was the main noise contributor during this monitoring period with traffic noise from the N3 and local road network also contributing. The LAeq,15 min for the night time monitoring period was 59 dB(A). The LA90, obtained at NSL 1 during the night time monitoring period was 47dB(A). This value represents the noise from the facility as well as some traffic noise from the N3 which was also relatively constant. The LA,max for the monitoring period was 80 dB(A) which was the result of a car travelling along Damastown Drive. Therefore it is considered that IPPC Licence night time noise limit of 45dBA (+2dB(A)) at the NSL, resulting from the Covidien facility, is met.

4.2 Monitoring Location N1

Monitoring location N1 is located to the west of the Covidien facility in the adjacent field.

Day Time

During the day time monitoring period, traffic from the N3 and local road network was the dominant noise source. The LAeq,30 min for the day time monitoring period was 53 dB(A). The LA90, obtained during the survey was 51dB (A). LA,max for the monitoring period was 66 dB(A) which was the result of overhead air traffic. The Covidien facility was slightly audible during this monitoring period.

Night Time

The Covidien facility was the main contributor during this monitoring period with traffic noise from the N3 and local road network also contributing. The LAeq,15 min for the night time monitoring period was 52 dB(A). The LA90, obtained at N1 during the night time monitoring period was 49dB(A). The LA,max for the monitoring period was 59 dB(A) which was the result of overhead air traffic.


IE0310297-22-RP-0001_A_01.DOC Page 12 of 20

4.3 Monitoring Location N2

Monitoring location N2 is located at the northern corner of the Covidien facility.

Day Time

The dominant noise source during the day time monitoring period was the WWTP control building. The LAeq,30 min for the day time monitoring period was 55 dB(A). The LA90, obtained during the survey was 54dB(A). LA,max for the monitoring period was 63 dB(A) which was the result of over head air traffic. It was noted that the doors to the WWTP control building were open and that noise at this location could be minimised by ensuring doors remain closed.

Night Time The WWTP control building was the main noise contributor during this monitoring period. The LAeq,15 min for the night time monitoring period was 55 dB(A). The LA90, obtained at N2 during the night time monitoring period was 54dB(A). The LA,max for the monitoring period was 60 dB(A) which was the result of over head air traffic. It was noted that the doors to the WWTP control building were again open and that noise at this location could be minimised by ensuring doors remain closed.

4.4 Monitoring location N3

Monitoring location N3 is located to the south of the Covidien facility.

Day Time

The dominant noise source during the day time monitoring period was local traffic. The LAeq,30 min for the day time monitoring period was 61 dB(A). The LA90, obtained during the survey was 55dB(A). LA,max for the monitoring period was 78 dB(A) which was the result of HGV movement on the local roundabout. The Covidien facility was faintly audible during the day time survey.

Night Time

An influx of local traffic on the roundabout during the monitoring period was the major noise contributor at this location. The LAeq,15 min for the night time monitoring period was 59 dB(A). The LA90, obtained at N3 during the night time monitoring period was 53dB(A). The LA,max for the monitoring period was 68 dB(A) which was the result of a car with a sport exhaust on the local roundabout. The influx of traffic which resulted in a high measurement came from Damastown Drive and so indicates a possible shift change in the International Business Machines (IBM) facility during the measurement period. Plant noise from the Covidien facility was also audible at this location.

4.5 Monitoring location N4

Monitoring location N4 is located to the east of the Covidien facility.

Day Time

The dominant noise source during the day time monitoring period was the WWTP and traffic on the local road network. The LAeq,30 min for the day time monitoring period was 51 dB(A). The LA90, obtained during the survey was 45dB(A). LA,max for the monitoring period was 65 dB(A) which was the result of over head air traffic.


IE0310297-22-RP-0001_A_01.DOC Page 13 of 20

Night Time

The WWTP was the main noise contributor during this monitoring period. The LAeq,15

min for the night time monitoring period was 48 dB(A). The LA90, obtained at N4 during the night time monitoring period was 42dB(A). The LA,max for the monitoring period was 57 dB(A) which was the result of an unknown noise source located off site.

4.6 Tonal Analysis

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

One-third octave band tonal analysis was employed and involves the calculation of an unweighted averaged noise level to represent the frequencies within each third of an octave. These noise levels are then compared with the noise levels calculated for the adjacent one-third octave bands. If a noise level is at least 5dB higher than the noise levels representing the adjacent bands then it is considered tonal, since it is significantly louder than noise levels at similar frequencies.

Tonal analysis results are given in Table 4.1 and Table 4.2. The aim of tonal analysis is to identify any tonal element to the noise emitted from the Covidien facility.

Table 4.1: Tonal Noise Results – Day time Noise Measurement Noise Level dB Frequency (Hz)

NSL 1 Tonal Noise not detected N1 Tonal Noise not detected N2 68 100 N3 Tonal Noise not detected N4 Tonal Noise not detected

The results in Table 4.1 indicate that tonal noise was present during the day time monitoring period at N2. Appendix B includes a graph of the 1/3 octave spectrum of noise sources for identification of tonal qualities for N2.

Table 4.2: Tonal Noise Results – Night time Noise Measurement Noise Level dB Frequency (Hz)

NSL 1 Tonal Noise not detected N1 Tonal Noise not detected N2 69 100 N3 Tonal Noise not detected N4 Tonal Noise not detected

The results in Table 4.2 indicate that tonal noise was present during the night time monitoring period at N2. Appendix B includes a graph of the 1/3 octave spectrum of noise sources for identification of tonal qualities for N2.

Condition 8.3 of the IPPC licence states:

‘There shall be no clearly audible tonal component or impulsive component in the noise emission from the activity at any noise sensitive location’

As such the Covidien facility is in compliance with condition 8.3 as no tonal noise was detected at the nearest noise sensitive location (NSL 1).

Although the Covidien facility is in compliance with Condition 8.3, tonal noise was detected at N2. It is believed that the source of this tonal noise came from the WWTP control building which is located approx 15m from N2. It was observed that the doors to the WWTP were open during both the day and night noise monitoring


IE0310297-22-RP-0001_A_01.DOC Page 14 of 20

periods and the tonal noise detected at N2 could possibly be eliminated by keeping these doors closed.

5. CONCLUSION

The findings of the noise monitoring at the Covidien site indicate that noise levels have reduced since the last IPPC Noise report. Ambient monitored LAeq noise levels are dominated by significant air traffic from Dublin Airport, and road traffic due to the industrial nature of the area and the proximity to a major national route (N3). Given the significant difference between the LAeq and LA90 (indicative of the Covidien facility contribution - see below) of greater than 10dB at the NSL it is considered that the Covidien facility is not a significant noise contributor at NSL 1.

Covidien’s IPPC licence requires that activities on-site shall not give rise to noise levels off-site, at noise sensitive locations, which exceed the limits of LAeq of 55dB(A) during the day and 45db(A) at night. The licence also states that

“Noise from the activity shall not give rise to sound pressure levels (Leq, 15) measured at noise sensitive locations which exceed the limit value(s) by greater than 2 dB(A).”

As noise emissions from the facility are considered continuous in nature it is deemed that the LA90 provides a good indication of noise arising from the Covidien facility. When analysing the LA90 for NSL 1, consideration also needs to be given to the fact that the LA90 is influenced by other external continuous noise sources, such as traffic from the N3 and the neighbouring Astellas facility.

During the day time noise monitoring period a LA90 of 48 dB(A) was measured at NSL 1 and as such noise levels at NSL 1 do not exceed the 55 dB(A) limit considering the continuous noise contribution of motor traffic and industrial noise from other adjacent premises.

During the night time noise monitoring period a LA90 of 47 dB(A) was measured at NSL 1 and as such noise levels at NSL 1 do not exceed the 45 dB (A) limit by greater than 2 dB(A) as per Condition 3 of the IPPC Licence.

Therefore the Covidien facility is deemed to be in compliance with condition 8.2 of their IPPC licence.

The results obtained at N1-N4 are the noise levels from within the Covidien-owned property and as such are not required to meet the respective 55 dB(A) and 45 dB(A) day and night time limits.

No tonal noise was detected at NSL 1 and therefore the Covidien facility is in compliance with condition 8.3 of the IPPC licence.

Tonal noise was detected at N2 which is believed to be a result of the doors to the WWTP control building being left open. In order to mitigate the detected tonal noise it is recommended that WWTP control building doors remain closed in so far as is reasonably possible.

No Covidien facility-related impulsive noises were audible during the monitoring periods.

No complaints in relation to noise emissions have been received by Covidien for the past year.


IE0310297-22-RP-0001_A_01.DOC Page 15 of 20

As IPPC compliance only relates noise impacts to the nearest noise sensitive location (NSL 1) the Covidien facility is deemed to be in compliance with Conditions 8.2 and 8.3 of the site’s IPPC licence considering existing background noise levels in the area and the facility’s noise contribution.


IE0310297-22-RP-0001_A_01.DOC Page 16 of 20

APPENDIX A

DRAWING SHOWING LOCATIONS OF NOISE MONITORING POINTS


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Figure 1: Locations of Noise Monitoring Points

NSL 1

N1

N3

N2

N4


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APPENDIX B

1/3 OCTAVE SPECTRUM GRAPH OF NOISE SOURCES FOR

IDENTIFICATION OF TONAL QUALITIES


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Day time Tonal Noise Analysis Figure 1: Frequency Spectrum for Day time Monitoring Period at N2

Figure 1: Frequency Spectrum for Daytime Monitoring Period at N2

0

10

20

30

40

50

60

70

80

16Hz

25Hz

40Hz

63Hz

100H

z

160H

z

250H

z

400H

z

630H

z

1000

Hz

1600

Hz

2500

Hz

4000

Hz

6300

Hz

1000

0Hz

Frequency

LLeq (

dB

)


IE0310297-22-RP-0001_A_01.DOC Page 20 of 20

Night time Tonal Noise Analysis Figure 2: Frequency Spectrum for Night time Monitoring Period at N2

Figure 2: Frequency Spectrum for Night time Monitoring Period at N2

0

10

20

30

40

50

60

70

80

16Hz

25Hz

40Hz

63Hz

100H

z

160H

z

250H

z

400H

z

630H

z

1000

Hz

1600

Hz

2500

Hz

4000

Hz

6300

Hz

1000

0Hz

Frequency

LL

eq

(d

B)

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