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Annual Environmental Report

for

Medtronic Galway

Licence Register No P0264-01

January – December 2008

March 2009

Medtronic Galway Annual Environmental Report for 2008

IPPC Register No P0264-01 March 2009

Table of Contents

1 INTRODUCTION ...................................................................................................................................... 1 1.1 GENERAL ............................................................................................................................................. 1 1.2 MEDTRONIC ENVIRONMENTAL, HEALTH, SAFETY AND ENERGY (EHSE) POLICY ............................ 2 1.3 COMPANY ORGANISATION CHART FOR ENVIRONMENTAL MANAGEMENT ........................................ 3

2 SUMMARY INFORMATION.................................................................................................................. 4 2.1 SELF-MONITORING DATA ................................................................................................................... 4

2.1.1 Emissions to Atmosphere Summary............................................................................................... 4 2.1.2 Summary of Emissions to Sewer.................................................................................................... 7 2.1.3 Summary of Groundwater Monitoring .......................................................................................... 8 2.1.4 Noise Monitoring ........................................................................................................................... 9 2.1.5 Waste Management Summary ..................................................................................................... 10

2.2 AGENCY MONITORING AND ENFORCEMENT ..................................................................................... 17 2.2.1 Site Inspection Report.................................................................................................................. 17 2.2.2 Agency Monitoring....................................................................................................................... 17

2.3 ENERGY & WATER CONSUMPTION ................................................................................................... 18 2.3.1 Energy Consumption.................................................................................................................... 18 2.3.2 Water Consumption ..................................................................................................................... 19

2.4 ENVIRONMENTAL INCIDENTS & COMPLAINTS.................................................................................. 20 2.5 AER RETURNS WEBFORM................................................................................................................. 20

3 MANAGEMENT OF THE ACTIVITY ................................................................................................ 21 3.1 INTRODUCTION .................................................................................................................................. 21 3.2 SCHEDULE OF ENVIRONMENTAL OBJECTIVES & TARGETS............................................................... 21 3.3 ENVIRONMENTAL MANAGEMENT PROGRAMME (EMP) REPORT FOR 2008 ..................................... 22 3.4 ENVIRONMENTAL MANAGEMENT PROGRAMME 2009 TO 2013........................................................ 24 3.5 POLLUTANT RELEASE AND TRANSFER REGISTER............................................................................. 30

3.5.1 Pollutant Release and Transfer Register Proposal..................................................................... 30 3.6 SOLVENT USAGE ............................................................................................................................... 31

3.6.1 Solvent Management Plan ........................................................................................................... 31 4 LICENCE-SPECIFIC REPORTS.......................................................................................................... 33

ANNEX A: AER RETURNS WEBFORM ANNEX B: MEDTRONIC GALWAY’S AER RETURNS WEBFORM PROPOSAL ANNEX C: BUND TEST CERTIFICATES


IPPC Licence Register No P0264-01 1 March 2009

1 Introduction

1.1 General This Annual Environmental Report (AER) is submitted to the Environmental Protection Agency (EPA) in compliance with Condition 2.9.2 of the Integrated Pollution Control (IPPC) Licence, Register No. P0264-01. In April 2007 Medtronic Galway was issued with an amended licence by way of a technical amendment. The AER contains information on the environmental performance of Medtronic Galway for the year January to December 2008. The following items are covered in this report:

• Emissions to atmosphere; • Emissions to sewer; • Groundwater analysis; • Waste management report; • Agency monitoring and enforcement; • Environmental incidents and complaints; • Energy consumption; • Environmental objectives and targets; • Environmental management programme; • Pollutant Release and Transfer Register; • Licence Specific Reports.

Medtronic Galway manufactures cardiovascular healthcare products at their plant in Parkmore Industrial Estate, Galway. At the end of 2008, the Company employed 2,293 people. Medtronic Galway operates an environmental management system certified to ISO 14001, a Safety Management System certified to OHSAS 18001 and an Energy Management System certified to IS 393.



1.2 Medtronic Environmental, Health, Safety and Energy (EHSE) Policy Consistent with our Mission, Code of Conduct, and EHS Vision, Medtronic is committed to conducting business in a safe, energy efficient and environmentally sustainable manner that promotes the health of our employees, customers, community and the Environment. All employees are expected to understand, follow and promote this Policy. Compliance We will comply with all applicable Environmental, Health, Safety and Energy (EHSE) laws, regulations and Medtronic Standards. We will conduct audits and implement practices to ensure compliance with these requirements. Continual Improvement We will establish EHSE goals, objectives and targets to continually improve our performance, in the efficient use of energy, in environmental, health and safety management and we will publicly report our progress. Business Integration We will integrate EHSE into business decisions to proactively ensure the health and safety of our employees and promote environmentally sustainable and energy efficient practices. Specifically, we will integrate an EHSE evaluation into product design manufacturing and distribution business processes and services that will reduce EHSE risk, improve EHSE performance, and promote pollution prevention and the efficient use of energy. Communication and Education We will communicate this policy to our employees, customers, shareholders, suppliers, community and other stakeholders. We will provide training and resources to enable employees to implement this Policy and share best practices throughout Medtronic in order to se energy efficiently, promote human and environmental health. Infrastructure We will maintain an EHSE infrastructure to assure the proper resources and accountability is established to meet this Policy. Gerard P. Kilcommins VP Global Vascular Operations and Managing Director Galway Site This Policy is implemented through Medtronic’s EHSE Management System.



1.3 Company Organisation Chart for Environmental Management Medtronic Galway’s Organisation Chart for Environmental Management is shown in Figure 1.

Figure 1: Medtronic Galway Environmental Management Organisational Chart

V.P of Operations & General Manager

V.P Operations

Senior Facilities Manager

1 × EHS Engineer 3 × EHS Specialists

EHS Manager



2 Summary Information

2.1 Self-Monitoring Data Unless stated otherwise, this summary information is provided for the period January to December 2008 inclusive as specified in the EPA’s Guidance Note for the Annual Environmental Report. This information is presented in accordance with the Guidance Note as annualised mass emission figures, derived from the average mass emission values multiplied by the duration of the emissions.

2.1.1 Emissions to Atmosphere Summary

Since the licence was granted in July 1997, the use of the licenced emission points has changed due to process changes and improvements, as notified to the Agency. The Emission Limit Values (ELVs) for emissions to atmosphere from the licenced emission points are set out in Schedule 1(i) of the Licence. Table 1 summarises their status during 2008. Table 1: Licensed Emission Points to Atmosphere (1

Emission Point Location Status

VEP-111 (1 Building 1 In operation



VEP-128 Building 1 Redundant since 1997




VEP-228 Building 2 Redundant since 2001 (1: These emission points are monitored on a quarterly basis.

Emissions are monitored from those emission points in operation on a quarterly basis by Enterprise Ireland on Medtronic Galway’s behalf. During 2008 emissions from additional emission points were also monitored, as requested by and agreed with the Agency. The additional monitoring was carried out at the emission points listed in Table 2.



Table 2: Additional Emission Points to Atmosphere Monitored in 2008

Emission Point Location Description

VEP-147 (1 Building 1 Extract from LEV (3 unit

VEP-136 (2 Building 1 Extract from LEV unit


VEP-152 (2 Building 1 Extract from isolator / LEV unit












VEP-313 (2 Building 3 Extract from LEV unit (1: These emission points are monitored on a quarterly basis. (2: These emission points were monitored in the 3rd and 4th quarters in 2008 at the request of the Agency. (3: Local Exhaust Ventilation

In order to estimate the annual mass emissions, the flow measured at the time of sampling was assumed to be representative of the average flow during plant operation, i.e. 16 hours per day, 236 days per year. Table 3 summarises the mass emissions to atmosphere from the licenced emission points during 2008. All mass emissions during the year were within the calculated annual Emission Limit Values (ELVs). As requested in the Agency’s Site Inspection Report issued in August 2006, emissions to atmosphere are reported as TA Luft Class I, II or III organic substances.



Table 3: Summary of Licensed Emissions to Atmosphere for 2008

Parameter Mass Emission 2008 (kg)

Licensed Emission Value (kg/yr)

TA Luft Class I <254.3 566

TA Luft Class II <254.3 2,832

TA Luft Class III <306.4 4,248

Total Class I, II & III <815.0 4,248

No non-compliances with regard to emission concentrations or mass emissions of organic compounds were recorded during the reporting period. Table 4 summarises the results of the additional monitoring carried out in the third and fourth quarters of 2008. The results from the two quarters have been pro-rated to estimate the quantities emitted to atmosphere for the full year. Table 4: Summary of Additional Monitoring of Emissions to Atmosphere in Q3 & Q4 for 2008

Parameter Mass Emission 2008 (kg)

TOC (1 <675

Ethanol <82.3

Chloroform <191

Active Ingredient <2.2 (1: Excludes the TOC contribution of ethanol and chloroform where both TOC and ethanol / chloroform

are analysed for.



2.1.2 Summary of Emissions to Sewer

Schedule 2(i) of the Licence sets out the ELVs for four licensed emission points to sewer. These are listed in Table 5. Table 5: Licensed Emission Points to Sewer

Emission Point Location Status

SEP-101 Building 1, East Side In operation, ongoing monitoring discontinued in 2005

SEP-102 Building 1, West Side In operation

SEP-201 (1 Building 2, East Side Process discharge discontinued in 2001

SEP-202 (1 Building 2, West Side Process discharge discontinued in 2000 (1: The designation of SEP-201 and SEP-202 in Schedule 2(i) of the licence is given as VEP-101 and VEP-102,

respectively In addition to the licenced emission points to sewer in Table 5, the Agency requested that monitoring of emissions to sewer at emission point SEP-401, a new emission point as notified to the Agency prior to the introduction of a new process in Building 4, be carried out in the third and fourth quarters of 2008. Tables 6 and 7 summarise the results of the monitoring carried out at the two emission points, SEP-102 and SEP-401, respectively. Table 6: Emissions to Sewer at SEP-102 in 2008

Average Measured Value

Licence Limit Parameter

Concentration (mg/l)

Annual Load

(kg) (2 Concentration

(mg/l) Annual Load

(kg) pH 7.6 - 6 – 9 -

BOD <60 <1.53 50 826 COD <286 <7.29 200 3,304 Suspended Solids <85 <2.17 100 1,652 Total Heavy Metals (1 <0.28 <0.007 1 16.5 Oils, Fats & Grease <1 <0.026 - - Organic Solvents <0.032 <0.0008 - -

(1: Parameters of Water Quality – Interpretation and Standards, EPA (2001). (2: The annual load for 2008 is based on a nominal flow rate of 108 litres per day.

Table 7: Emissions to Sewer at SEP-401 in 2008

Parameter Units Average Measured Concentration

pH pH units 8.1 BOD mg/l <3.5 COD mg/l <21 Suspended Solids mg/l <1 Total Heavy Metals (1 mg/l 0.077 Oils, Fats & Grease mg/l <1 Organic Solvents mg/l 0.022



(1: Parameters of Water Quality – Interpretation and Standards, EPA (2001). Due to the nature of the emission from SEP-102, there is not always a sufficient quantity of discharge to sample. In addition, due to a fault by the test laboratory carrying out the analysis on the samples, results for only six samples were available from SEP-102 for the year. Two samples were taken at SEP-401 during the third and fourth quarters of 2008. During 2008, the discharge from SEP-102 exceeded the licenced emission limit values for COD, BOD and suspended solids, as summarised in Table 8. In addition, the annual average concentrations of COD and BOD were in excess of the licenced emission limit value. However, the annual loads for all licenced parameters were significantly below the licenced annual load. Table 8: Non-compliances of Emissions to Sewer (2008)

Date Parameter Measured Concentration (mg/l)

Emission Limit Value (mg/l)

COD 504 200 BOD 96 50 October 2008 Suspended Solids 212 100 COD 811 200 BOD 156 50 November 2008 Suspended Solids 257 100 COD 251 200 December 2008 BOD 74 50

Additional monitoring of the discharge from the laboratory giving rise to the emission from SEP-102 was carried out in February 2009 in order to determine the cause of the non-compliances. The results and findings of this monitoring will be reported in the AER for 2009.

2.1.3 Summary of Groundwater Monitoring

The IPPC Licence states that groundwater from a borehole at the North-East corner of Building 1 should be analysed twice a year. However, in 2002 this requirement was revised by the Agency to one monitoring event per year. Two samples were taken from the borehole, in April and October 2008, and analysed by Environmental Laboratory Services Limited (ELS). The results of the analysis are summarised in Table 9, including comparison with the parametric values (PV) from SI 439 of 2000, the European Communities (Drinking Water Regulations) 2000, which came into force in January 2004. This comparison is for indicative purposes only as the groundwater from the well is not a source of drinking water. The Interim Guideline Values published in the Agency’s Interim Report Towards Setting Guideline Values for the Protection of Groundwater in Ireland are also included in this Table for comparison.



Table 9: Summary of Groundwater Monitoring Results

Parameter Units Drinking Water PV EPA IGV April October

pH pH units 6.5 – 9.5 6.5 – 9.5 7.3 7.6

Conductivity µS/cm 2,500 1,000 604 619

COD mg/l - - <8 <8

Total Ammonia mg/l 0.3 0.15 0.12 0.16

Total Nitrogen mg/l - - 1 3

Chloride mg/l 250 30 23.8 24

Organic Solvents mg/l - - ND ND

Organohalogens mg/l - - ND ND (1: Concentration was below the limit of detection

The Agency’s Site Inspection Report issued in August 2006 required that the parameters used in the production process be analysed for separately. The analysis carried out by Environmental Laboratory Services Limited includes analysis for a wide range of volatile organic compounds, including those used in the production process. The results of the two sampling rounds in 2008 showed that each of the VOCs analysed for was below the limit of detection.

2.1.4 Noise Monitoring

A noise survey was carried out at the site on 22nd December 2008. The results of this survey are summarised in Tables 10 and 11. Table 10: Summary of Sound Pressure Levels (unweighted) per Octave Band

Location Octave bands (Hz) & sound pressure levels (dB) 31.5 63 125 250 500 1k 2k 4k 8k

Impulsive or tonal qualities

DAYTIME Rear of B1 61 63 54 48 47 49 44 33 27 none Rear of B2 65 65 57 52 52 52 50 46 39 none Rear of B3 62 62 51 48 45 53 41 37 33 none Rear of B4 68 64 56 52 49 50 47 42 35 none NSL 1 68 70 66 67 68 72 67 57 48 none NSL 2 72 76 70 69 68 72 68 58 50 none

NIGHT TIME

Rear of B1 55 57 50 44 44 45 39 33 31 none Rear of B2 64 59 52 45 44 45 39 35 33 none Rear of B3 59 56 48 44 41 39 36 37 34 none Rear of B4 60 49 41 37 41 37 34 28 34 none NSL 1 65 62 59 59 62 66 61 50 39 none NSL 2 64 68 59 60 62 67 63 52 43 none



Table 11: Summary of Sound Pressure Levels (dB(A))

Location L(A)eq L(A)10 L(A)90 DAYTIME

Rear of Building 1 52 54 49 Rear of Building 2 57 56 50 Rear of Building 3 49 50 46 Rear of Building 4 54 55 51 Noise Sensitive Location 1 75 79 56 Noise Sensitive Location 2 75 79 65

NIGHT TIME

Rear of Building 1 48 49 46 Rear of Building 2 48 49 46 Rear of Building 3 45 46 44 Rear of Building 4 42 47 44 Noise Sensitive Location 1 68 72 44 Noise Sensitive Location 2 49 71 48

The results summarised in Table 11 indicate that the noise levels at the noise sensitive locations (houses to the north and south of the industrial estate) are greater than 55 dB(A) and 45 dB(A), respectively. However, the noise survey report concluded that the noise levels at these locations are determined by traffic levels on the road network (the estate access road, the N6, the N17 and local roads in the area). The report also concluded that there was no evidence of noise emanating from any of the Medtronic buildings at the noise sensitive locations.

2.1.5 Waste Management Summary

In compliance with condition 7 of the Licence, a register of hazardous and non-hazardous waste is maintained at Medtronic Galway. The following information is recorded in the waste register:

a) The names of the agent and transporter of the waste; b) The names of the persons responsible for the ultimate disposal or recovery of the

waste; c) The ultimate destination of the waste; d) Written confirmation of the acceptance and disposal/recovery of any hazardous

waste consignments sent off-site; e) The tonnage and European Waste Catalogue (EWC) Codes for the waste materials

listed in Schedule 3(i) and 3(ii) of the IPC Licence, where these materials have been disposed as waste during the year;

f) Details of any rejected consignments; g) Details of Waste Collection Permit Numbers of those transferring the waste.

Table 12 presents a summary of the waste arising during 2008. Details of Waste Collection Permit numbers are given in Table 13. Details of waste treatment facility permit numbers are given in Table 14.



Table 12: Summary of Waste Arisings for 2008

EWC Code

Hazardous Yes/No

Description of Waste

Quantity (tonnes)

Method of Disposal/ Recovery

Location of Disposal/ Recovery

Name of Waste Disposal/Recovery

Contractor

Name of Waste Collection Contractor

06 01 02 Yes

Hydrochloric acid & Hydrogen peroxide

0.59 D10

(c) AVG, Hamburg , Germany (c) Indaver NV, Belgium

Indaver Ireland Indaver /Cyril McGuinness Transport

06 01 05 Yes Nitric Acid 1.80 D10



06 01 06 Yes Laboratory smalls 0.11 D10



06 02 05 Yes Laboratory smalls 0.02 D10 (c) AVG, Hamburg ,

Germany Indaver Ireland Indaver /Cyril McGuinness Transport

07 05 04 Yes Hydrocarbon waste 2 68.39 D10



07 05 04 Yes Contaminated glassware 7.74 D10



08 03 12 Yes Ink tins 0.43 D10



08 04 09 Yes Contaminated plastic sharps 3.59 D10



(a) Waste is disposed of / recycled on-site, (b) Waste is disposed of / recycled off-site in Ireland, (c) Waste is disposed of / recycled abroad



Table 12: Summary of Waste Arisings for 2008 (cont/d)

EWC Code

Hazardous Yes/No


Quantity (tonnes)




Contractor


11 01 06 Yes Electropolish Solution (acids)

27.2 D10



13 08 99 Yes Waste lubricating & hydraulic oil

0.18 D10 (c) AVG, Hamburg , Germany Indaver Ireland Indaver /Cyril McGuinness

Transport

14 06 02 Yes

Waste chloroform, dichloro-methane & packaging

15.27 D10

(c) AVG, Hamburg , Germany (c) Indaver NV, Belgium (c) ATM, Netherlands


14 06 03 Yes Hydrocarbon waste 1 15.9 D10



14 06 03 Yes Laboratory smalls 0.08 D10 (c) AVG, Hamburg ,


15 01 10 Yes Empty containers 5.36 D10



15 02 02 Yes Waste wipes 38.42 D10



16 02 13 Yes WEEE (computer monitors)

1.22 R3/R4 (b) Tullamore, Co Offaly KMK Metals Recycling Ltd. KMK Metals Recycling Ltd.





EWC Code

Hazardous Yes/No


Quantity (tonnes)




Contractor


16 03 03 Yes Waste base 0.23 D10



16 03 05 Yes Waste base 0.17 D10 (c) AVG, Hamburg , Germany Indaver Ireland Indaver /Cyril McGuinness

Transport

16 05 04 Yes Waste aerosol cans 0.04 D10 (c) AVG, Hamburg ,


16 05 06 Yes Laboratory smalls 0.20 D10



16 05 07 Yes Laboratory smalls 0.01 D10 (c) AVG, Hamburg,




16 06 01 Yes Lead acid batteries 0.64 R4

(c) HJ Enthoven, UK (c) AppaRec NV, Belgium

Returnbatt Limited

Indaver /Cyril McGuinness Transport KMK Metals Recycling Ltd.

16 09 04 Yes Cidex 0.76 D10 (c) AVG, Hamburg, Germany Indaver Ireland Indaver /Cyril McGuinness

Transport



18 01 03 Yes Waste biohazard material

0.04 D10 (c) AGR Vertrieb, Germany Ecosafe Systems Limited Indaver /Cyril McGuinness

Transport

20 01 21 Yes Fluorescent tubes 0.214 R4/R5

(b) Athy, Co. Kildare (c) Essen, Germany

Irish Lamp Recycling Company Limited DELA GmbH. Recycling

Irish Lamp Recycling Company Limited Enva





EWC Code

Hazardous Yes/No


Quantity (tonnes)




Contractor


15 01 01 No Cardboard 85.12 R3

(c) Glasgow, UK (c) Dordrecht, The Netherlands

Highlander International Recycling Peute Paper Recycling

Barna Waste

15 01 03 No Timber 67.02 R3

(b) Redmondstown, Clonmel, Tipperary (b) Scariff, Co. Clare (b) Ballinrobe, Co. Mayo

Willamette Europe Ltd. Finsa Forest Products Ltd. Mid West Pallets

Barna Waste

15 01 04 No Aluminium cans 0.24 R4 (c) Tyne and Wear, UK Alternative Waste Solutions Barna Waste

16 02 14 No Electronic waste 1.35 R4 (b) Tullamore, Co

Offaly KMK Metals Recycling Ltd. KMK Metals Recycling Ltd.

16 02 16 No Electronic waste 0.11 R4 (b) Tullamore, Co

Offaly KMK Metals Recycling Ltd. KMK Metals Recycling Ltd.

17 04 07 No Scrap metal 0.69 R4 (c) Tyne and Wear, UK Alternative Waste Solutions Barna Waste

20 01 01 No Paper 96.5 R3

(c) Glasgow, UK (c) Dordrecht, The Netherlands

Highlander International Recycling Peute Paper Recycling

Barna Waste

20 01 02 No Glass 3.4 R5 (b) Parkmore Business Park West, Co. Galway (b) Kilrush, Co. Clare

Rehab Enterprises Limited Tullagower Quarries

Rehab Enterprises Limited Barna Waste

20 01 08 No Canteen Waste 50.52 R10 (b) Headford Road, Co. Galway

Carrowbrowne Composting Facility City Bin Company

20 01 25 No Cooking Oil 1.06 R9 (c) Strabane, Co Tyrone Frylite Frylite





EWC Code

Hazardous Yes/No


Quantity (tonnes)




Contractor


20 01 39 No Plastics 42.7 R5 (c) Tyne and Wear, UK (c) London, UK (c) Glasgow, UK

Alternative Waste Solutions Asia Global Trade Ltd. Highlander International Recycling

Barna Waste

20 03 01 No General Waste 169.34 D1 (b) Ballinasloe, Co. Galway

East Galway Residual Landfill Site (Greenstar) Barna Waste




Table 13: Waste Collection Permit Details

Waste Collection Contractor Waste Collection Permit Number Issuing Authority

Barna Waste CW 74 Mayo County Council

City Bin Company CW 26 Mayo County Council

Cyril McGuinness Transport CW 52 Mayo County Council

Frylite CW 227 Mayo County Council

Irish Lamps Recycling Co. CW 95 Mayo County Council

KMK Metals Recycling Ltd CW 93 Mayo County Council

Rehab Enterprises Limited CW 190 Mayo County Council

Table 14: Waste Disposal / Recovery Permit / Licence Details

Waste Disposal / Recovery Contractor

Waste Licence / Permit Number Issuing Authority

Alternative Waste Solutions YNA838807CB UK Environment Agency AGR mbH, RZR Herten / Im Linen E56252039 Bezirksregierung Munster

AppaRec N.V. MLAV1/9700000299/GVD

A/ DLAMV/00070572/1000

OVAM, Belgium

Asia Global Trade Ltd., London TNE/377194/B Environment Agency

ATM Netherlands 02/03762 – AVE200213784 821780 SenterNoven

AVG Hamburg, Germany IB2234/AVG-GENB-2 Umweltbehorde Carrowbrowne Composting Facility W0013-01 EPA

Connaught Timber Products WR/01-3 Galway County Council DELA GmbH. Recycling, Essen, Germany E11315322 LANU

East Galway Residual Landfill Site (Greenstar) W0178-01 EPA

Finsa Forest Products Ltd. W0022-01 EPA

H.J. Enthoven A57205 Environment Agency

Highlander International Recycling SCO/044794/CB SEPA

Indaver NV, Belgium. MLAVI/9800000485 OVAM, Belgium

Irish Lamps Recycling Co 02/2000A Kildare County Council

KMK Metals Recycling Limited W0113-01 EPA

Mid-West Pallets n/a n/a Peute Paper Recycling, the Netherlands OPK 2005 OPK

Rehab Enterprises Limited CW190 Mayo County Council

Returnbatt 97/2002 Kildare County Council

Tullagower Quarries, 011/02/WP/CL Clare County Council



Table 14: Waste Disposal / Recovery Permit / Licence Details (cont/d)

Waste Disposal / Recovery Contractor

Waste Licence / Permit Number Issuing Authority

Rilta Environmental W0192-02 EPA

TechRec WP 98099 Dublin City Council

Willamette Europe Ltd. W0593-01 EPA

2.2 Agency Monitoring and Enforcement

2.2.1 Site Inspection Report

On 21st July 2008 the Agency visited Medtronic Galway and carried out a site inspection. The inspection report highlighted a single non-compliance with the conditions of the licence. In addition, the Agency made four observations regarding the overall environmental performance of the site. Medtronic replied to the Agency addressing the non-compliance and observations highlighted in the inspection report.

2.2.2 Agency Monitoring

The Agency visited the site on 6th June 2008 and carried out monitoring of emissions to atmosphere from four emission points: VEP 113, VEP 152, VEP 153 and VEP 158. The results of this monitoring are summarised in Table 15. Table 15: Results of Agency Monitoring of Emissions to Atmosphere on 6th June 2008

Parameter VEP 113 VEP 152 VEP 153 VEP 158

Class I Organics

mg/Nm3 ND (1 ND ND 11.8

kg/h ND ND ND 0.015

Class II Organics

mg/Nm3 ND ND ND ND

kg/h ND ND ND ND

Class III Organics

mg/Nm3 15 ND ND ND

kg/h 0.07 ND ND ND (1: Not detected.



The Agency visited the site on 26th February 2008 and again on 18th September 2009 to sample the discharge from emission points SEP-101 and SEP-102. During both visits there was no flow at SEP-101 and during the visit in September there was no flow at SEP-102. Therefore, the only results obtained by the Agency were from SEP-102 in February 2008. These results are listed in Table 16. Table 16: Results of Agency Monitoring of SEP-102 on 26th February 2008

Parameter Units Value Licence Limit

Temperature °C 11.4 25°C

pH (at 20°C) pH units 7.7 6 to 9 pH units

BOD mg/l O2 1.4 50 mg/l

COD mg/l O2 <25 200 mg/l

Suspended Solids mg/l <8 100 mg/l

Chromium µg/l <1 -

Nickel µg/l <1 -

Copper µg/l 33 -

Zinc µg/l 240 -

Cadmium µg/l 0.70 -

Lead µg/l <1 -

Total Heavy Metals µg/l nm (1 1 mg/l

Toxicity TU nm 5 TU (1: not measured

2.3 Energy & Water Consumption

2.3.1 Energy Consumption

The energy consumed by Medtronic Galway during the year as electricity, gas oil (heating oil), liquid petroleum gas (LPG) and natural gas is summarised in Table 17 and Figure 2. All values are given in megawatt hours (MWh). Table 17: Summary of Energy Consumption 2003− 2008

Energy Source

Usage 2004 (MWh)

Usage 2005 (MWh)

Usage 2006 (MWh)

Usage 2007 (MWh)

Usage 2008 (MWh)

Electricity 10,372 11,075 12,594 13,601 13,134

Gas Oil 5,276 5,613 4,005 1,362 1,249

LPG 669 862 475 427 442

Natural Gas - - 1,738 5,468 6,118

Total Energy 16,317 17,550 18,812 20,858 20,943



Historical Energy Consumption

0

2,000

4,000

6,000

8,000

10,000

12,000

14,000

16,000

Electricity Gas Oil LPG Natural Gas

Ene

rgy

Cons

umpt

ion

(MW

h)

20042005200620072008

Figure 2: Historical Energy Consumption

2.3.2 Water Consumption

Medtronic Galway’s water consumption for 2008 is given in Table 16 below. Consumption for previous years is included for comparison. Table 18: Summary of Water Consumption for 2008

Water Source

Usage 2004 (m3)

Usage 2005 (m3)

Usage 2006 (m3)

Usage 2007 (m3)

Usage 2008 (m3)

Municipal Supply 18,867 35,160 35,956 39,564 28,507

During 2008, a number of projects were carried out to target water consumption at the site. These projects delivered significant water savings towards the end of the year and are expected to deliver further savings during 2009.



2.4 Environmental Incidents & Complaints There were no environmental incidents in 2008. Medtronic did not receive any complaints during the reporting period.

2.5 AER Returns Webform The AER Returns Webform for Medtronic Galway is attached in Annex A to this report.



3 Management of the Activity

3.1 Introduction In this section of the AER, we report on the initiatives taken at Medtronic Galway to improve our environmental performance. We also set out our objectives and targets and report on the progress of our Environmental Management Programme during 2008.

3.2 Schedule of Environmental Objectives & Targets Our Environmental Objectives and Targets, as set out in the Environmental Management Programme contained in our last AER, are summarised in Table 19. Table 19: Schedule of Environmental Objectives & Targets from 2008-2012 EMP

Top tier Environmental Objective

Environmental Targets

1. Optimise use of cleaner production techniques in manufacturing

1.1 Assess the environmental impact of new developments. 1.2 Assess the environmental impact of transferred products from

other Medtronic sites. 1.3 Optimise storage quantities of chemicals so as to reduce

waste 1.4 Reduce chemical usage, waste and air emissions from DES

production 1.5 Reduce fugitive emissions to meet the requirements of the

Solvent Regulations by October 2007 1.6 Reduce solid waste from cleaning operations in

manufacturing

2. Optimise energy efficiency and utilities usage

2.1 Perform trend analysis on energy and water usage. 2.2 Devise performance indicators and set reduction targets. 2.3 Minimise compressed air leaks 2.4 Investigate use of CHP. 2.5 Establish and certify an Energy Management System to IS

393 2.6 Reduce specific (employee) water consumption

3. Maximise recovery, re-use and recycling of waste

3.1 Implement an auditing programme for waste contractors. 3.2 Reduce quantity of compostable waste sent to landfill 3.3 Reduce input packaging waste 3.4 Reduce Product Packaging 3.5 Optimise Recycling of waste packaging

4. Minimise the frequency and impact of environmental incidents

4.1 Implement a testing programme for bunded areas. 4.2 Implement a testing programme for underground pipes and

drains.

5. Develop and implement an integrated Environmental, Health & Safety (EHS) management system

5.1 Maintain environmental management system to ISO 14001 5.2 Provide training in environmental management 5.3 Maintain emergency response capability at high level 5.4 Reduce number of single-occupancy car journeys to site by

employees



3.3 Environmental Management Programme (EMP) Report for 2008 Our report on the progress made against our environmental targets in 2008, as listed in Table 19, is set out below. Target Ref.

Report

1. Optimise Use of Cleaner Production Techniques in Manufacturing

1.1 Environmental impact assessments were carried out on new products and product variations introduced during 2008 in accordance with the procedure in the Design History File.

1.2 Environmental impact assessments were carried out on transferred products (from other Medtronic site to the Galway facility) during 2008 in accordance with the procedure in the Design History File.

1.3 The roll-out of new work benches, which reduce chemicals usage, continued in 2008. A site-wide audit of chemicals storage was carried out in 2008 in manufacturing areas. Checklists on storage locations were introduced. Audits of chemicals storage have now been incorporated into the routine area audits. The optimisation of chemical storage quantities is now complete for the present.

1.4 A reduction in the use of chloroform by a third in DES manufacturing was achieved by devising and validating a change from a 3-rinse to a 2-rinse process. Efforts to reduce ethanol usage by a third in DES cleaning continued in 2008 and are ongoing. The replacement of ethanol with a detergent-based cleaner is being investigated.

1.5 Quarterly solvent mass balances were conducted in 2008. The annual mass balance indicates that the level of fugitive emissions in 2008 was less than 10% of the total solvent input for the year (see also Section 3.6.1 of the AER).

1.6 The results of the hygiene study undertaken in 2007 were written up. Some changes were implemented, e.g. the sequencing of transferring material to/from isolators and changes in handling practices. A proposal to reduce the use of gloves in certain areas requires Medtronic Corporate approval and this is being processed.

2. Optimise Energy Efficiency and Utilities usage

2.1 The BMS installations are fully complete. Data on gas, water and electricity usage in the production buildings was extracted and analysed during 2008.

2.2 The following energy saving projects were completed in 2008: − C-flow hoods in DES manufacturing are now switched off during hours of non-occupancy; − A solar water heating system was installed in Building 1; − The ventilation rate in all the manufacturing areas was reduced to 20 air changes per hour,

down from 35 air changes per hour in some instances; − A closed-loop cooling water system for installed for the modular stent oven in Building 1; − A solenoid valve was installed on the cooling water discharge from the moulding machine

in Building 3, thus limiting the discharge to when the machine is in use; − Light fitting in the clean rooms in Building 2 where changed from type T8 to the more

energy efficient type T5.



Target Ref.

Report

2. Optimise Energy Efficiency and Utilities usage

2.3 Annual leak detection surveys were carried out in 2008 and all leaks were repaired promptly.

2.4 The proposal to install a CHP plant was not approved as the project was not economical due to the changes in energy costs.

2.5 Medtronic Galway received certification to IS 393 for its Energy Management System in August 2008.

2.6 There was no progress on benchmarking water usage in 2008 because of the continued difficulty with the accuracy of the water consumption data for the site. Good monitoring data is now available from the BMS systems and water consumers are being targeted through awareness schemes (water consumption at Medtronic Galway is driven by employee usage rather than production usage).

3. Maximise Recovery, Re-use and Recycling of Waste

3.1 The non-hazardous waste contractor was audited in 2008. The hazardous waste contractor will be audited in 2009.

3.2 Trending of compostable waste diverted from landfill continued in 2008. In 2008, 9.75% of total non-hazardous waste, and 14.5% of recycled waste, was composted.

3.3 The paper copy of the instructions for use (IFUs) contained in each product carton have been eliminated in two product lines. The IFUs have been replaced by an online system which can be accessed by the physicians.

3.4 Work on reducing Endeavor packaging from a double to a single pouch continued in 2008.

3.5 The project to reduce packaging waste that requires shredding before recycling was completed. An audit of the recyclable waste contractor was carried out in July 2008 to identify improvements that would increase the amount of recyclables. The findings will be implemented in 2009.

4. Minimise the Frequency and Impact of Environmental Incidents

4.1 The oil storage, chemstore and waste chemical yard bunds were all tested during 2008 and certified.

4.2 The next test programme for the underground pipelines and drains is due in 2009 under the 3-year test frequency.

5. Develop & Implement an Integrated EHS Management System

5.1 Internal audits of the environmental management system were completed during 2008. The EMS was reviewed quarterly by senior management.

5.2 Environmental management training was provided to new personnel as part of the induction process in 2008. Refresher training was provided to staff. A Sustainability Week was held at Medtronic Galway in February 2008 with the focus on energy and water usage, and waste, both in the home and in the workplace. Information stands were set up in the canteens with information provided on inter alia solar panels, home insulation and boiler efficiency. It is planned to hold a Sustainability Week as an annual event in future.



Target Ref.

Report

5. Develop & Implement an Integrated EHS Management System

5.3 On-site training was provided for the Emergency Response Team during 2008, which included a simulated spill exercise. A fire simulation and another simulated chemical spill exercise will be carried out in 2009. Two groups from the Emergency Response Team attended fire and chemical spill training at the Fire Training Centre in Sligo. A third group will attend in 2009.

5.4 A bus service is now provided to the industrial park.

3.4 Environmental Management Programme 2009 to 2013 Our Environmental Management Programme for 2009 to 2013 is set out on the following pages, with targets and actions grouped under the individual top-tier environmental objectives. Each action is assigned to a particular function group within Medtronic Galway and start and finish dates are set.



Table 20: Environmental Management Programme 2009-2013

Objective No 1 Optimise use of Cleaner Production Techniques in Manufacturing

Target Action Responsibility Start Date Finish Date 1.1 Assess the environmental impact of

new developments. • Conduct impact assessments in accordance with the procedure in the

Design History file.

B1, B2 & B3 Manufacturing

Ongoing Ongoing

1.2 Assess the environmental impact of transferred products from other Medtronic sites.

• Conduct impact assessments in accordance with the procedure in the Design History file.

B1, B2 & B3 Manufacturing

Ongoing Ongoing

1.3 Reduce chemical usage, waste and air emissions from DES production.

• Reduce ethanol usage. DES Manufacturing

Q1 08 Q2 09

1.4 Eliminate use of methylene chloride. • Investigate replacing methylene chloride with ethanol for cleaning stents.

DES Manufacturing

Q1 09 Q3 09

1.5 Reduce fugitive emissions to meet the requirements of the Solvent Regulations.

• Complete solvent mass balance for 2008 and conduct quarterly solvent mass balances in 2009.

Environment, Health & Safety

Dept

Q1 09

Ongoing



Table 20 (cont’d): Environmental Management Programme 2009-2013

Objective No 2 Optimise Energy Efficiency & Utilities Usage

Target Action Responsibility Start Date Finish Date

2.1 Perform trend analysis on energy and water usage.

• Extract and analyse data on oil, water and electricity usage from new BMS’ in Buildings 1, 2 & 3.

Facilities Dept.

Ongoing

Ongoing

2.2 Reduce electricity consumption and green house gases emissions by 10% by 2013 based on 2007 figures.

• Devise and implement reduction programmes based on performance indicators for electricity, gas and water usage. Target air compressors, chillers, boilers and lighting.

Facilities Dept. Q3 08 Q4 13

2.3 Minimise compressed air leaks. • Conduct annual leak detection surveys. B1, B2 & B3 Manufacturing

Annual

Annual

2.4 Maintain an Energy Management System to IS 393.

• Roll out the elements of IS 393 across the site. Environment, Health & Safety

Dept.

Q1 09

Q4 09

2.5 Reduce specific (employee) water consumption.

• Benchmark Medtronic’s water consumption against the healthcare industry.

• Set water reduction targets for consumers.

Facilities Dept. Q3 09

Q4 10

Q3 10

Q4 11




Objective No 3 Maximise Recovery, Re-use & Recycling of Waste

Target Action Responsibility Start Date Finish Date 3.1 Implement an auditing programme

for waste contractors.

• Audit hazardous waste contractor. Environment, Health & Safety

Dept.

Q3 09 Q3 09

3.2 Reduce quantity of compostable waste sent to landfill

• Implement composting of canteen waste. Trend percentage of waste composted over time.


Dept.

Ongoing

Ongoing

3.3 Reduce input packaging waste • Identify opportunities for reducing input packaging waste as part of roll-out of new Supplier/Inventory Management System

Planning

Q1 08 Q4 09

3.4 Reduce product packaging • Reduce complexity and size of Endeavor packaging

R&D Q4 07 Q2 09

3.5 Optimise recycling of waste packaging

• Implement findings from July 2008 waste audit to shift the sorting function for recyclable waste to the waste contractor.


Dept.

Q2 09 Q4 09




Objective No 4 Minimise the Frequency & Impact of Environmental Incidents

Target Action Responsibility Start Date Finish Date

• Inspect and test bunded areas and underground tanks at 3-year intervals.

Facilities Dept. Q1 11

Q4 11

4.1 Implement a testing programme for bunded areas.

• Seal the hardstanding area in front of the Chemical Stores to maintain the integrity of this bunded area.


4.2 Implement an inspection programme for underground pipes and drains

• Carry out an inspection of underground pipelines and drains at 3-year intervals.





Objective 5 Develop & Implement an Integrated Environmental, Health & Safety (EHS) Management System

Target Action Responsibility Start Date Finish Date 5.1 Maintain environmental management

system to ISO 14001.

• Conduct internal audits. • Conduct formal reviews of the EHS system.


Dept.

Ongoing Ongoing

• Implement environmental awareness programme across the site and repeat annually.


Dept.

Ongoing Ongoing 5.2 Provide training and awareness in environmental management.

• Hold a Sustainability Week on the site for employees as an annual event.


Dept.

Q1 09 Q1 09

• Conduct simulation exercises annually.


Dept.

Ongoing Ongoing 5.3 Maintain emergency response capability at high level.

• Provide off-site training module for third group from Emergency Response Team.


Dept.

Q3 09 Q3 09



3.5 Pollutant Release and Transfer Register Table 21 lists the emissions reported to the Agency in the AER Returns Webform under the Agency’s Web-Based Reporting System and the PRTR in accordance with EC Regulation 166/2006 concerning the establishment of a European Pollutant Release and Transfer Register and following correspondence from the Agency outlining the requirements of this new reporting framework. These emissions are included in Annex A and submitted to the Agency electronically. Table 21: Emissions Reported in the AER Returns Webform for 2008

Emission

Release Medium Type of Emission / Potential Emission

Carbon Dioxide Air Routine (combustion) Carbon Monoxide Air Routine (combustion) Dichloromethane Air Routine (process) Hydrochlorofluorocarbons Air Accidental (refrigerants) Hydrofluorocarbons Air Accidental (refrigerants) Methane Air Accidental (natural gas) Nitrogen Oxides Air Routine (combustion) Non-methane VOCs Air Routine (process) Sulphur Oxides (SOX/SO2) Air Routine (combustion) TA Luft Organics Class I Air Routine (process) TA Luft Organics Class II Air Routine (process) TA Luft Organics Class III Air Routine (process) Trichloromethane Air Routine (process) BOD Water (Sewer) Routine (process) COD Water (Sewer) Routine (process) Oils, Fats & Grease Water (Sewer) Routine (process) Suspended Solids Water (Sewer) Routine (process) Total Heavy Metals Water (Sewer) Routine (process) Total Organic Compounds (as C or COD/3) Water (Sewer) Routine (process)

It should be noted that dichloromethane, as a named PRTR substance and also a non-methane VOC, is reported under both categories in the AER Returns Webform. The emissions of natural gas and refrigerants are estimated on the basis that no accidental releases occurred during 2008.

3.5.1 Pollutant Release and Transfer Register Proposal

Medtronic Galway’s proposal for reporting under the PRTR and the Agency’s Web Based Reporting System for 2009 is attached in Annex B to this report.



3.6 Solvent Usage At the request of the Agency, in a letter dated 15th October 2002, VOCs are reported as Total Organic Carbon. In 2008, these VOCs included ethyl alcohol, denatured ethyl alcohol, isopropyl alcohol, acetonitrile, butanone and acetone. Table 22 lists the solvents used at the site during 2008. Table 22: Solvent Usage (2008)

No. Material Units Usage 2007 Usage 2008

1 Total Organic Carbon kg 38,350 38,235

2 Halogenated Organic Compounds (excluding Methylene Chloride) kg 4,931 6,616

3 Methylene Chloride kg 3,576 5,047

4 Xylene kg 2.2 1.2

5 Ethylbenzene kg 0.7 0.4

3.6.1 Solvent Management Plan

During 2007, Medtronic Galway developed a Solvent Management Plan in order to assist in the monitoring and control of fugitive solvent emissions from the site. This plan identified the inputs of solvents into the manufacturing process at the site, the generation of waste solvent and subsequent disposal from the site, including solvent contained within waste wipes, and the solvent emissions to atmosphere from the licenced emission points. A solvent mass balance was carried out for the full calendar year 2008 to quantify the fugitive emissions from the site. Figure 3 shows a schematic for the mass balance. The results of the solvent mass balance indicate that the fugitive solvent emissions to air from Medtronic Galway’s operations in 2008 were less than 5% of the total solvent input. In our 2007 AER we identified a number of measures to develop the accuracy of the data used in the mass balance, in particular to carry out additional sampling of the waste solvent to determine its water content. This sampling was carried out in 2008 and the results were applied to the 2008 mass balance calculation. Additional sampling of the waste solvent will be carried out in 2009 to further refine the accuracy of the data used in the balance. Table 23 summarises the solvent balance for 2008.



Table 23: Solvent Mass Balance

Item Solvent Quantity

Solvent In 84,023 Bulk solvents (kg) 83,702 Solvents in inks (kg) 321

Solvent Out: 82,806 Solvent in Product (kg) 0 Waste Solvent in Drums (kg) 73,628 Solvent in Waste Wipes (kg) 7,026 Solvent in Waste Inks (kg) 0 Solvent Emissions from Licenced Stacks (kg) 2,152 Solvent Emissions from Minor Emission Points (kg) 0 Solvent Emissions from AHU Discharges (kg) 0

Fugitive Solvent Emission (kg) 1,217

% Fugitive Emission 1.45%

Figure 3: Solvent Mass Balance at Medtronic Galway

Solvents in emissions from licenced stacks

Solvents in emissions from AHUs

Unaccounted-for solvent emissions

Solvents in emissions from minor emission points

MEDTRONIC GALWAY’S

OPERATIONS

Waste solvents

Solvents in waste mixes

Solvents in waste wipes

Residual solvents in product

Purchased raw solvents

Solvents in purchased mixes (e.g. inks)



4 Licence-Specific Reports During 2008 the oil storage, chemstore and waste chemical yard bunds were tested. The test certificates are attached in Annex C.


IPPC Licence Register No P0264-01 March 2009

Annex A

AER Returns Webform

| PRTR# : P0264 | Facility Name : Medtronic Vascular Galway Limited | Filename : 270-X058 2008 Medtronic Galway AER Returns Webform P0264_2008.xls | Return Year : 2008 | 3694 31/03/2009 12:41

Version 1.1.02REFERENCE YEAR 2008

1. FACILITY IDENTIFICATIONParent Company Name Medtronic Vascular Galway Limited

Facility Name Medtronic Vascular Galway LimitedPRTR Identification Number P0264

Licence Number P0264-01

Waste or IPPC Classes of ActivityNo. class_name

Address 1 Medtronic Vascular Galway Ltd.Address 2 Parkmore Industrial EstateAddress 3 GalwayAddress 4

Country IrelandCoordinates of Location 13402283

River Basin DistrictNACE Code 325

Main Economic Activity Manufacture of medical and dental instruments and suppliesAER Returns Contact Name Catherine Kinsella

AER Returns Contact Email Address [email protected] Returns Contact Position EHS Engineer

AER Returns Contact Telephone Number 091-708223AER Returns Contact Mobile Phone Number

AER Returns Contact Fax Number 091-708656Production Volume 0.0

Production Volume UnitsNumber of Installations 0

Number of Operating Hours in Year 0Number of Employees 0

AER Returns Worksheet

User Feedback/CommentsWeb Address

2. PRTR CLASS ACTIVITIESActivity Number Activity Name

3. SOLVENTS REGULATIONS (S.I. No. 543 of 2002)Is it applicable?

Have you been granted an exemption ?If applicable which activity class applies (as per

Schedule 2 of the regulations) ?Is the reduction scheme compliance route being

used ?

4.1 RELEASES TO AIR | PRTR# : P0264 | Facility Name : Medtronic Vascular Galway Limited | Filename : 270-X058 2008 Medtronic Galway AER Returns Webform P0264_2008.xls | Return Year : 2 31/03/2009 12:418 8 16 25 33 35 6 6 6 11 6 9 28

SECTION A : SECTOR SPECIFIC PRTR POLLUTANTS

QUANTITY

No. Annex II Name M/C/E Method Code Designation or Description Emission Point 1 T (Total) KG/Year A (Accidental) KG/Year F (Fugitive) KG/Year0.0 0.0 0.0 0.0

* Select a row by double-clicking on the Pollutant Name (Column B) then click the delete button

SECTION B : REMAINING PRTR POLLUTANTS

QUANTITY

VEP-111 VEP-112 VEP-113 VEP-227Additional

Emission PointsSite Combustion

Plant

No. Annex II Name M/C/E Method Code Designation or Description Emission Point 1 Emission Point 2 Emission Point 3 Emission Point 4 Emission Point 5 Emission Point 6 T (Total) KG/YearA (Accidental) KG/Year

F (Fugitive) KG/Year

03 Carbon dioxide (CO2) C OTH

Application of CO2 emissionfactor to combustion of natural gas, gas oil and LPGused at the site. 0.0 0.0 0.0 0.0 0.0 1682092.0 1682092.0 0.0 0.0

02 Carbon monoxide (CO) E Estimate 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0

35 Dichloromethane (DCM) M OTHCharcoal tube samples andGC\FID analysis 0.0 0.0 0.0 0.0 52.1 0.0 52.1 0.0 0.0

04 Hydro-fluorocarbons (HFCs) E Estimate 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.014 Hydrochlorofluorocarbons (HCFCs) E Estimate 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.001 Methane (CH4) E Estimate 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.008 Nitrogen oxides (NOx/NO2) E Estimate 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0

07 Non-methane volatile organic compounds (NMVOC) M OTHPortable FID and mass balance 276.4 44.2 0.0 442.4 325.4 0.0 2305.4 0.0 1217.0

11 Sulphur oxides (SOx/SO2) E Estimate 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.058 Trichloromethane E Estimate 0.0 0.0 0.0 0.0 191.0 0.0 191.0 0.0 0.0


SECTION C : REMAINING POLLUTANT EMISSIONS (As required in your Licence)

QUANTITYVEP-111 VEP-112 VEP-113 VEP-227

Pollutant No. Name M/C/E Method Code Designation or Description Emission Point 1 Emission Point 2 Emission Point 3 Emission Point 4 T (Total) KG/YearA (Accidental) KG/Year

F (Fugitive) KG/Year

230 TA Luft organic substances class 1 M OTH

Adsorption onto charcoaltubes and subsequent screening using Gas Chromatography / Mass Spectrometry 92.1 14.7 0.0 147.5 254.3 0.0 0.0






Additional Data Requested from Landfill operators

Landfill: Medtronic Vascular Galway LimitedPlease enter summary data on the quantities of methane flared and / or utilised

additional_pollutant_no T (Total) kg/Year M/C/E Method CodeDesignation or

DescriptionFacility Total Capacity m3

per hourTotal estimated methane generation (as per sit

model) 0.0 N/AMethane flared 0.0 0.0 (Total Flaring Capacity)

Methane utilised in engine/s 0.0 0.0 (Total Utilising Capacity)Net methane emission (as reported in Section A

above) 0.0 N/A

For the purposes of the National Inventory on Greenhouse Gases, landfill operators are requested to provide summary data on landfill gas (Methane) flared or utilised on their facilities to accompany the figures for total methane generated. Operators should only report their Net methane (CH4) emission to the environment under T(total) KG/yr for Section A: Sector specific PRTR pollutants above. Please complete the table below:

Method Used

RELEASES TO AIRPOLLUTANT METHOD

Method Used

POLLUTANT

RELEASES TO AIR

RELEASES TO AIR

Method UsedMETHOD

POLLUTANT METHOD

Method Used

4.2 RELEASES TO WATERS | PRTR# : P0264 | Facility Name : Medtronic Vascular Galway Limited | Filename : 270-X058 2008 Medtronic Galway AER Returns Webform P0264_2008.xls | Ret 31/03/2009 12:418 8 16 16 24 24 6 6 6 6 6 6

SECTION A : SECTOR SPECIFIC PRTR POLLUTANTS Data on ambient monitoring of storm/surface water or groundwater, conducted as part of your licence requirements, should NOT be submitted under AER / PRTR Reporting as this only concerns Releases from your facility

QUANTITY



SECTION B : REMAINING PRTR POLLUTANTS

QUANTITY



SECTION C : REMAINING POLLUTANT EMISSIONS (as required in your Licence)

QUANTITY

Pollutant No. Name M/C/E Method Code Designation or Description Emission Point 1 T (Total) KG/Year A (Accidental) KG/Year F (Fugitive) KG/Year0.0 0.0 0.0 0.0


RELEASES TO WATERS

RELEASES TO WATERS

Method Used

POLLUTANTMethod Used

POLLUTANT

POLLUTANTRELEASES TO WATERS

Method Used

4.3 RELEASES TO WASTEWATER OR SEWER | PRTR# : P0264 | Facility Name : Medtronic Vascular Galway Limited | Filename : 270-X058 2008 Me 31/03/2009 12:418 8 16 20 6 6 6 6 0

SECTION A : PRTR POLLUTANTS

QUANTITYSEP-102

No. Annex II Name M/C/E Method Code Designation or Description Emission Point 1 T (Total) KG/Year A (Accidental) KG/Year F (Fugitive) KG/Year

76 Total organic carbon (TOC) (as total C or COD/3) M CRM

3rd Party INAB accredited laboratory method (TM 00010, closed reflux calorimectric) 2.43 2.43 0.0 0.0


SECTION B : REMAINING POLLUTANT EMISSIONS (as required in your Licence)

QUANTITY

Pollutant No. Name M/C/E Method Code Designation or Description Emission Point 1 T (Total) KG/Year A (Accidental) KG/Year F (Fugitive) KG/Year

303 BOD M OTH 3rd Party laboratory method 1.53 1.53 0.0 0.0

306 COD M CRM

3rd Party INAB accredited laboratory method (TM 00010, closed reflux calorimectric) 7.29 7.29 0.0 0.0

314 Fats, Oils and Greases M OTH 3rd Party laboratory method 0.026 0.026 0.0 0.0

240 Suspended Solids M CRM

3rd Party INAB accredited laboratory method (EW013, suspended solids by gravimetric analysis) 2.17 2.17 0.0 0.0

347 Total heavy metals M CRM

3rd Party INAB accredited laboratory method (EM 130, metals by ICP-MS) 0.007 0.007 0.0 0.0


OFFSITE TRANSFER OF POLLUTANTS DESTINED FOR WASTE-WATER TREATMENT OR SEWER

OFFSITE TRANSFER OF POLLUTANTS DESTINED FOR WASTE-WATER TREATMENT OR SEWER

Method Used

Method Used

POLLUTANT METHOD

POLLUTANT METHOD

4.4 RELEASES TO LAND | PRTR# : P0264 | Facility Name : Medtronic Vascular Galway Limited | Filename : 270-X058 2008 Medtronic Galway AER Returns Webform P0264_ 31/03/2009 12:428 8 16 16 6 6 6 6

SECTION A : PRTR POLLUTANTS

QUANTITY

No. Annex II Name M/C/E Method Code Designation or Description Emission Point 1 T (Total) KG/Year A (Accidental) KG/Year0.0 0.0 0.0


SECTION B : REMAINING POLLUTANT EMISSIONS (as required in your Licence)

QUANTITY

Pollutant No. Name M/C/E Method Code Designation or Description Emission Point 1 T (Total) KG/Year A (Accidental) KG/Year0.0 0.0 0.0


POLLUTANT METHODMethod Used

RELEASES TO LAND

RELEASES TO LAND

POLLUTANT METHODMethod Used

5. ONSITE TREATMENT & OFFSITE TRANSFERS OF WASTE | PRTR# : P0264 | Facility Name : Medtronic Vascular Galway Limited | Filename : 270-X058 2008 Medtronic Galway AER Returns Webform P0264_2008.xls | Return Year : 2008 | 31/03/2009 12:425 43 0

Transfer DestinationEuropean Waste

Code HazardousQuantity T/Year Description of Waste

Waste Treatment Operation M/C/E Method Used

Location of Treatment

Name and Licence / Permit No. of Recoverer / Disposer /

BrokerAddress of Recoverer /

Disposer / Broker

Name and Address of Final Destination i.e. Final

Recovery / Disposal Site (HAZARDOUS WASTE

ONLY)

Licence / Permit No. of Final Destination i.e. Final


ONLY)

To Other Countries 06 01 02 Yes 0.59 Hydrochloric acid & hydrogen peroxide D10 M Weighed Abroad Indaver, W0036-02Tolka Quay Road, Dublin Port, Dublin 1

AVG, Hamburg, GermanyIndaver NV, Belgium

IB2234/AVG-GENB-2MLAVI/9800000485

To Other Countries 06 01 05 Yes 1.8 Nitric acid D10 M Weighed Abroad Indaver, W0036-02Tolka Quay Road, Dublin Port, Dublin 1



To Other Countries 06 01 06 Yes 0.11 Laboratory smalls D10 M Weighed Abroad Indaver, W0036-02Tolka Quay Road, Dublin Port, Dublin 1



To Other Countries 06 02 05 Yes 0.02 Laboratory smalls D10 M Weighed Abroad Indaver, W0036-02Tolka Quay Road, Dublin Port, Dublin 1 AVG, Hamburg, Germany IB2234/AVG-GENB-2

To Other Countries 07 05 04 Yes 68.39 Hydrocarbon waste no. 2 D10 M Weighed Abroad Indaver, W0036-02Tolka Quay Road, Dublin Port, Dublin 1



To Other Countries 07 05 04 Yes 7.74 Contaminated glassware D10 M Weighed Abroad Indaver, W0036-02Tolka Quay Road, Dublin Port, Dublin 1



To Other Countries 08 03 12 Yes 0.43 Ink tins D10 M Weighed Abroad Indaver, W0036-02Tolka Quay Road, Dublin Port, Dublin 1



To Other Countries 08 04 09 Yes 3.59 Contaminated plastic sharps D10 M Weighed Abroad Indaver, W0036-02Tolka Quay Road, Dublin Port, Dublin 1



To Other Countries 11 01 06 Yes 27.2 Electropolish solution (acids) D10 M Weighed Abroad Indaver, W0036-02Tolka Quay Road, Dublin Port, Dublin 1



To Other Countries 13 08 99 Yes 0.18 Waste lubricating & hydraulic oil D10 M Weighed Abroad Indaver, W0036-02Tolka Quay Road, Dublin Port, Dublin 1 AVG, Hamburg, Germany IB2234/AVG-GENB-2

To Other Countries 14 06 02 Yes 15.27Waste chloroform, dichloromethane & packaging D10 M Weighed Abroad Indaver, W0036-02

Tolka Quay Road, Dublin Port, Dublin 1

AVG, Hamburg, GermanyIndaver NV, BelgiumATM, Netherlands

IB2234/AVG-GENB-2MLAVI/980000048502/03762 – AVE200213784821780

To Other Countries 14 06 03 Yes 15.9 Hydrocarbon waste no. 1 D10 M Weighed Abroad Indaver, W0036-02Tolka Quay Road, Dublin Port, Dublin 1




To Other Countries 15 01 10 Yes 5.36 Empty containers D10 M Weighed Abroad Indaver, W0036-02Tolka Quay Road, Dublin Port, Dublin 1



To Other Countries 15 02 02 Yes 38.42 Waste wipes D10 M Weighed Abroad Indaver, W0036-02Tolka Quay Road, Dublin Port, Dublin 1



Within the Country 16 02 13 Yes 1.22 WEEE (computer monitors) R5 M Weighed Offsite in IrelandKMK Metals Recycling, W0113-01

Cappincur, Tullamore, Co Offaly

KMK Metals Recycling, Cappincur, Tullamore, Co Offaly W0113-01

To Other Countries 16 03 03 Yes 0.23 Waste base D10 M Weighed Abroad Indaver, W0036-02Tolka Quay Road, Dublin Port, Dublin 1



To Other Countries 16 03 05 Yes 0.17 Waste base D10 M Weighed Abroad Indaver, W0036-02Tolka Quay Road, Dublin Port, Dublin 1 AVG, Hamburg, Germany IB2234/AVG-GENB-2

To Other Countries 16 05 04 Yes 0.04 Waste aerosol cans D10 M Weighed Abroad Indaver, W0036-02Tolka Quay Road, Dublin Port, Dublin 1 AVG, Hamburg, Germany IB2234/AVG-GENB-2

To Other Countries 16 05 06 Yes 0.2 Laboratory smalls D10 M Weighed Abroad Indaver, W0036-02Tolka Quay Road, Dublin Port, Dublin 1





To Other Countries 16 06 01 Yes 0.64 Lead acid batteries R4 M Weighed Abroad

Indaver, W0036-02

Returnbatt, 97/2002

Tolka Quay Road, Dublin Port, Dublin 1Old Mill Industrial Estate, Kill, Co. Kildare

Apparec NV, Belgium

HJ Enthoven, UK

MLAV1/9700000299/GVDA/DLAMV/00070572/1000

A57205

To Other Countries 16 09 04 Yes 0.76 Cidex D10 M Weighed Abroad Indaver, W0036-02Tolka Quay Road, Dublin Port, Dublin 1 AVG, Hamburg, Germany IB2234/AVG-GENB-2


To Other Countries 18 01 03 Yes 0.04 Waste biohazard material D10 M Weighed AbroadEcosafe Systems Limited, W0054-01

Unit 1 A, Allied Industrial Estate, Kylemore Road, Ballyfermot, Dublin 10, Dublin.

AGR mbH, RZR Herten/Im Linen, Germany E56252039

Within the Country 20 01 21 Yes 0.214 Fluorescent tubes R4 M Weighed Offsite in IrelandIrish Lamp Recycling Company Limited, 02/2000A

Woodstock Industrial Estate, Kilkenny Road, Athy, Co Kildare

Irish Lamp Recycling Company Limited, Woodstock Industrial Estate, Kilkenny Road, Athy, Co Kildare 02/2000A

Method Used

Transfer DestinationEuropean Waste

Code HazardousQuantity T/Year Description of Waste

Waste Treatment Operation M/C/E Method Used

Location of Treatment

Name and Licence / Permit No. of Recoverer / Disposer /

BrokerAddress of Recoverer /

Disposer / Broker

Name and Address of Final Destination i.e. Final


ONLY)

Licence / Permit No. of Final Destination i.e. Final


ONLY)

Method Used

To Other Countries 15 01 01 No 85.12 Cardboard R3 M Weighed Abroad

Highlander International Recycling, SCO/044794/CBPeute Paper Recycling, OPK 2005

Highlander House, 1 Teign Grove, East Kilbride, Glasgow, UKBaanhoekweg 4, 3313 LA Dordrecht, The Netherlands

Within the Country 15 01 03 No 67.02 Timber R3 M Weighed Offsite in IrelandFinsa Forest Products Limited, P0022-01 Scariff, Co. Clare

To Other Countries 15 01 04 No 0.24 Aluminium cans R4 M Weighed AbroadAlterantive Waste Solutions, YNA838807CB

Britannia Business Park, Point Pleasant Industrial Estate, Wallsend, Newcastle-Upon-Tyne, UK

Within the Country 16 02 14 No 1.35 Electronic waste R5 M Weighed Offsite in IrelandKMK Metals Recycling, W0113-01


Within the Country 16 02 16 No 0.11 Electronic waste R5 M Weighed Offsite in IrelandKMK Metals Recycling, W0113-01


To Other Countries 17 04 07 No 0.69 Scrap metal R4 M Weighed AbroadAlterantive Waste Solutions, YNA838807CB


To Other Countries 20 01 01 No 96.5 Paper R3 M Weighed Abroad

Highlander International Recycling, SCO/044794/CBPeute Paper Recycling, OPK 2005

Highlander House, 1 Teign Grove, East Kilbride, Glasgow, UKBaanhoekweg 4, 3313 LA Dordrecht, The Netherlands

Within the Country 20 01 02 No 3.4 Glass R5 M Weighed Offsite in IrelandTullagower Quarries, 011/02/WP/CL Kilrush, Co. Clare

Within the Country 20 01 08 No 50.52 Canteen waste R3 M Weighed Offsite in IrelandCarrowbrowne Composting Facility, W0013-01 Carrowbrowne, Galway

To Other Countries 20 01 25 No 1.06 Cooking oil R9 C Volume Calculation Abroad Frylite, NI00201Orchard Road, Strabane, Co Tyrone, Northern Ireland

To Other Countries 20 01 39 No 42.7 Plastics R5 M Weighed AbroadAlterantive Waste Solutions, YNA838807CB


Within the Country 20 03 01 No 169.34 General waste D1 M Weighed Offsite in Ireland Greenstar, W0178-01East Galway Residual Landfill Site, Galway

* Select a row by double-clicking the Description of Waste then click the delete button



Annex B

Proposal for Reporting under the Pollution Release & Transfer Register (PRTR)



Pollution Release & Transfer Register (PRTR) Regulation

List of Substances to be Reported by Medtronic Galway for 2009

Emission Release Medium

Type of Emission / Potential Emission.

Carbon Dioxide Air Routine (combustion) Carbon Monoxide Air Routine (combustion) Dichloromethane Air Routine (process) Hydrochlorofluorocarbons Air Accidental (refrigerants) Hydrofluorocarbons Air Accidental (refrigerants) Methane Air Accidental (natural gas) Nitrogen Oxides Air Routine (combustion) Non-methane VOCs Air Routine (process) Sulphur Oxides (SOx/SO2) Air Routine (combustion) TA Luft Organics Class I1 Air Routine (process) TA Luft Organics Class II1 Air Routine (process) TA Luft Organics Class III1 Air Routine (process) Trichloromethane Air Routine (process) BOD1 Water (Sewer) Routine (process) COD1 Water (Sewer) Routine (process) Oils, Fats & Grease Water (Sewer) Routine (process) Suspended Solids1 Water (Sewer) Routine (process) Total Heavy Metals1 Water (Sewer) Routine (process) Total Organic Compounds (as C or COD/3) Water (Sewer) Routine (process)

1 These emissions are licensed emissions.



Annex C

Bund Test Certificates

annual environmental report for medtronic galway · annual environmental report for medtronic...

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