IPPC Application Summary & Update · Engineer, Metrology Helen Brigdale Assistant, Administration...

EXECUTIVE SUMMARY ....................................................................... 1

1.0 INTRODUCTION ............................................................................... 2

1.1 General ......................................................................................... 2 1.2 Brief Site Description .................................................................... 2 1.3 Environmental, Health and Safety Policy ...................................... 3 1.4 Organisational Structure --- Administration ................................... 4 1.5 Organisational Structure --- Environmental ................................... 5

2.0 SUMMARY OF EMISSIONS 2017 ...................................................... 6

2.1 Emissions to Air ............................................................................ 6 2.2 Emissions to Sewer (Trade Effluent Discharges) .......................... 8 2.3 Emissions to Surface Water ........................................................ 10 2.4 Waste Management .................................................................... 10 2.5 Resource Consumption .............................................................. 14 2.6 2017 Environmental Incidents & Complaints ............................... 15 2.7 EPA Monitoring and Enforcement ............................................... 15

3.0 MANAGEMENT OF THE ACTIVITY ................................................ 16

3.1 Environmental Management Programme (EMP) ......................... 16 3.2 Pollution Release and Transfer Register (PRTR) ........................ 16

4.0 LICENCE SPECIFIC REPORTS ....................................................... 17

4.1 Environmental Noise Monitoring Report ...................................... 17 4.2 2017 Solvent Management Plan ................................................. 19 4.3 Energy Efficiency Auditing .......................................................... 23 4.4 Decommissioning Management Plan (DMP) Review .................. 23 4.5 Environmental Liabilities Risk Assessment (ELRA) Review ........ 23 4.6 Statement of Measures ............................................................... 24 4.7 Testing of Underground Tanks, Sewer Pipes and Bunds ............ 24 4.8 Waste Prevention, Minimisation and Recycling Summary ........... 24 4.9 Raw Material Usage and Efficiency ............................................ 24 4.10 Minimisation of Water Demand and Trade Effluent ..................... 24 4.11 Long Range Environmental Improvement Goals (2014-2018)..... 24 4.12 Submitted Reports 2017 ............................................................. 25

APPENDIX A – AER RETURNS WORKSHEET ....................................... 26

5.1 Releases To Air 2017 ....................................................................... 27 5.2 Releases To Water 2017 .................................................................. 28 5.3 Releases To Sewer 2017 ................................................................. 29 5.4 Site Transfers of Waste 2017 ........................................................... 30

APPENDIX B – 2017 EMP UPDATE ....................................................... 33

APPENDIX C – 2018 EMP PROPOSAL ................................................... 35

31-March 2018 2 of 37 Annual Environmental Report 2017

1.0 Introduction

1.1 General

Abbott Ireland Vascular Division (Abbott), Cashel Road, Lawlesstown, Clonmel, Co. Tipperary, holds an IPPC Licence Register No. P0847-01, for “The use of coating materials in processes with a capacity to use at least 10 tonnes per year of organic solvents”. The Licence was issued by the EPA on 16th of December 2008. This Annual Environmental Report (AER) represents the fourth full AER for the Clonmel site and covers the period from 01-January 2017 to 31-December, 2017. The AER has been prepared in accordance with the EPA ‘Guidance Note for Annual Environmental Report’ and other relevant updated guidance notes as provided by the EPA on the agency website (www.epa.ie).

1.2 Brief Site Description

The site is located on a 7.8 hectare site, 2 km north of Clonmel town. Abbott is a medical device manufacturer which manufactures bare metal cardiac stents, drug coated cardiac stents and balloon dilatation catheters and vessel closure devices. There are four main production areas:

1. Implants (Bare Metal Stent Manufacture) – Xience, Xience P, Ultra,

The stent manufacturing process involves the cutting of small diameter metal tubes using high powered laser cutters. Stents are polished and cleaned with acids and solvent.

2. Stent Delivery System (SDS) – ML8, Graftmaster, Armada 14, Omnilink Elite In SDS stent delivery catheters are assembled, the principal operations are physical assembly, tubing necking (i.e. thinning tubing down to a specific diameter) and bonding (usually by table-top laser).

3. Drug Eluting Stent (DES) – Xience V, Xience Prime, Xience Xpedition

In the DES process the stent is coated with a solvent based drug/polymer solution. Solvents are also used here for both cleaning and spraying equipment.

4. Vessel Closure Devices (VC) – Starclose, Proglide, Prostar

Vessel closure products facilitate the secure closure of the vascular access site after coronary and peripheral catheterizations. The devices are hand assembled in stages using a range of metal and plastic parts bonded together with solvent and solvent wipes used for cleaning parts and work stations.

Site support services include offices, canteen, laboratories, shipping, warehousing, utilities, engineering, etc. The site currently employs approximately 1,400 personnel and operates two 8-hour shifts per day, Monday to Thursday, and two 7-hour shifts on Friday.

http://www.epa.ie/


1.3 Environmental, Health and Safety Policy


1.4 Organisational Structure --- Administration

Pat McLoughlin

Site Director, AVD

Clonmel

Deirdre Mullins

Director, Operations

Michael Tarrant

Manager, Operations

Liam O’Carroll

Director, Human

Resources

Pat Kealy

Director, Quality

Sarah Noonan

Manager, Quality Assurance

(M/L)

Elaine O’Mahony (LOA)


Sean Ward

Manager, Engineering Pat Walsh

Manager, Operations

David McElroy

Manager, Engineering

William Boxwell

Senior Director,

Manufacturing

Operations

Aisling Cooney

Manager, Operations

Aiden Heney


Elaine Gleeson

Manager, Operations

Kevin Finn

Manager, Business ExcellenceConor Rainsford

Director, Operations

Diarmuid Meagher

Director, Innovation &

Technology Advancement

Sean Corkery

Financial Controller

Danny Flannery

Controller, Global

Operations

Pauline Hanley

Senior Director, QA

Operations

Margaret Morrissey

Country Director, HR

Joan Casey

Executive Assistant

Tony Mannion

Director, IT Business

Relationships, Global

Manufacturing

Kerry Williams

Manager,R & D

Melissa Devane


David Fleming

GL, Component Engineering

Ger Murphy

Manager, Facilities

Mike Crowe

DVP, Manufacturing

Operations

Priscilla Kerr


Maeve Corcoran

Financial Controller (M/L)

Maureen Slattery (P/L)

Manager, Supply Chain

Fiona Sinnott


Rodney Poche

Manager, IT Business

Relationships


1.5 Organisational Structure --- Environmental

Barry McGrathSupervisor, Facilities

Peader Furlong Engineer, Metrology

Helen Brigdale Assistant,

Administration

Gary Doyle Calibration,

Equipment & Facilities Dispatcher

Alan Lee Mark Hickey

Brian Shinnick Technician, Calibration

John Kiely Gerry Millea Paul Burke

Damien KelleherJohn FoxOpen x 1

Technician, Facilities

Sean ReadeBrendan RyanPeadar Furlong

Associate, Facilities

Lorcan CarrollGroup Lead, EHS

Nigel Hickey, Environmental

Coordinator

Gerard MurphyManager,

Facilities/EHS


2.0 Summary of Emissions 2017 2.1 Emissions to Air

2.1.1 Emissions to Air Overview

Air emissions are monitored on a quarterly basis for Total Organic Carbon (TOC) and twice yearly for Pharmaceutical Dust in accordance with Schedule B.1 & C.1.2 of our IPPC Licence. Monitoring was completed in accordance with EPA Guidance Note AG2. Sampling of air emissions was conducted by ‘Catalyst Environmental’ for the operational licensed emission points. Of the eight main emission points only four (A2-1, A2-2, A2-7 and A2-8) were operational during 2017 for stent manufacture. The results for these four emission points were calculated using the relevant quarterly and biannual monitoring data results. A mass emission (kg/hr) was calculated for each sample and an average figure calculated for each parameter. The average value was then multiplied by the hours of operation to generate an annual mass emission value. A summary of emissions to air for 2017 is outlined in Table 2.1.1(a) below.

Table 2.1.1 (a), Summary of 2017 TOC & Pharmaceutical Dust Emissions to Atmosphere

Emission Type

Air Stack Ref.

Location Monitoring

Frequency

Analysis Method

2016 Mass Load (Kg’s)

2017 Mass Load

(Kg’s)*

Mass Load Limit (Kg’s)

Complies with

Licence Limit

Total Organic Carbon (TOC)

A2-1

Suite No.2 – Stent coating, oven drying operations and equipment repair fumehood.

Quarterly I.S. EN 12619. (FID)

237.40 381.58 4785 Yes

A2-2 Suite No.2 – Mandrel solvent cleaning.

495.29 827.02 3790 Yes

A2-7 Suite No.1 – Stent coating and drying operations.

343.38 286.52 4785 Yes

A2-8 Suite No.1 – Drug Formulation.

78.12 151.67 3790 Yes

A2-3 New Vessel Closure Manufacture

Re-monitoring due after planned 2018 line changes, EPA submission to be completed after

same.

458.27 458.27 n/a n/a

A2-4 318.24 318.24 n/a n/a

A2-5 129.42 129.42 n/a n/a

Pharma Dust

A2-1

Suite No.2 – Stent coating, oven drying operations and equipment repair fumehood.

Biannually ISO 9096

Total Particulate

<0.004 <0.002 4.1 Yes

A2-2 Suite No.2 – Mandrel solvent cleaning.

<0.002 <0.002 4.1 Yes

A2-7 Suite No.1 – Stent coating and drying operations.

<0.004 <0.002 4.1 Yes

A2-8 Suite No.1 – Drug Formulation.

<0.003 <0.002 4.1 Yes

*Based on the average quarterly mass emissions (kg/hr) x 16 (hrs/day) x 255 (days/yr) plus a basic 5% weekend overtime correction. For all TOC (as C) concentration limits:- The average of all readings in one monitoring exercise shall not exceed the emission limit values; and no hourly average shall exceed 1.5 times the emission limit. At least three consecutive readings shall be obtained in each monitoring exercise.


Table 2.1.1 (b), Summary of 2017 Emissions to Air (Maximum result as % of Limit)

Table 2.1.1 (c), Summary of 2017 TOC & Pharmaceutical Dust Emissions Flowrates

Emission Type

Air Stack Ref.

2017 Average Hourly

Flowrate (m3)

2017 Maximum Hourly

Flowrate (m3)*

Hourly Flowrate Limit

(m3)

Complies with Licence Limit

Volumetric Flowrate

A2-1 7259 8221 11729 Yes

A2-2 6832 7552 9288 Yes

A2-7 7236 7630 11729 Yes

A2-8 5900 7548 9288 Yes

Note: (*) Maximum flowrates are limited by fan speeds.

2.1.2 Interpretation of Emissions to Air Data

There were no Emission Limit Value (ELV) or Flowrate exceedances for emissions to atmosphere during 2017. Three new emission points (Vessel Closure Manufacture) were in use during 2017 for solvent discharges only (A2-3, A2-4, A2-5). Initial baseline VOC exhaust monitoring was completed for these emission points but planned changes to Vessel Closure operations in 2018 will require re-monitoring to be completed. On completion of monitoring a formal results submission to the EPA will be made. During 2018 the site will continue to explore opportunities to reduce solvent emission to air via improved operational controls. The sites pharmaceutical dust monitoring results continue to show levels below the analytical detection limit. The site expects the high level of air emissions compliance to continue during 2018.

TOC A2-1

TOC A2-2

TOC A2-7

TOC A2-8

Pharma Dust A2-1

Pharma Dust A2-2

Pharma Dust A2-7

Pharma Dust A2-8

31

0.05

0.05

0.05

0.05

18

Parameter

25

8

Annual Air

Emissions

(Max result as % of

EPA limit)

0 25 50 75 100


2.2 Emissions to Sewer (Trade Effluent Discharges)

2.2.1 Emissions to Sewer Overview

A summary of trade effluent emissions to sewer for 2017 are shown in Table 2.2.1(a) below. Table 2.2.1(a), Summary of 2017 Emissions to Sewer

Ref Parameter

Sampling

Frequency

Analysis Method

Mass Emissions (Kg’s) 2016

Mass Emissions (Kg’s) 2017

Licensed Mass Emission Limit

(Kg’s)*

Complies with

Licence

SE-1

Volume Daily 17401 m3 15252 m3 73,000 m3 Yes

Temperature Continuous 18.59°C

(Max) 21.39 °C

(Max) 35°C Yes

pH Continuous Min: 6.61

Max: 9.26 Min: 5.68 Max: 9.16

5-10 Yes

BOD Quarterly G/04 APHA

2005, Method 5210B

941.1 2898.2 29,200 Yes

COD Quarterly G/03 APHA

2005 Method 5220D

1793.2 6266.1 45,625 Yes

Suspended Solids

Quarterly G/19 APHA

2005, Method 2540B

1428.5 972.7 29,200 Yes

Orthophosphate Quarterly G/67 APHA 2005, 4500-

PE 1.9 4.8 730 Yes

Oils, Fats & Grease

Quarterly G/032 APHA

Method 5520B

173.7 325.6 2,738 Yes

Sulphate Quarterly

G/67 Konelab

764 444.1 3,650 Yes

Total Heavy Metals

Annual

USEPA 200.8

14.6 4.8 N/A Yes

Acetone Annual G/14 Based

on ASTM Method D3695

243.6 442.3 N/A Yes

IPA Annual 14.2 30.5 N/A Yes

Other Organics**

Annual <L.O.D <L.O.D N/A Yes

Table Notes:

*Based on 365 days/year, i.e., kg/day Emissions Limit Values x 365. ** Results for other Organic Compounds (other than Acetone and IPA) were below their respective limits of detection (LOD) – this includes DCM, Heptane, Cyclohexanone, Methanol and Acetonitrile. N/A – Not Applicable. <LOD – Less than the level of detection.

The above results are based upon average composite sample monitoring data for each parameter. The average figures were multiplied by the total annual flow to calculate the mass emissions for 2017. Sampling was conducted by ANUA (Bord Na Mona) in accordance with Schedule B.3 & C.3.2 of the Licence for the sites licensed emission point, SE-1. Changes between 2017 and 2016 reported data are due to normal sampling variation with no significant process or operational changes to report.


Table 2.2.1(b), Summary of 2017 Maximum Emissions Concentrations to Sewer (As a % of Limit)

Table 2.2.1(c), 2017 Toxicity Testing Results

Test Parameter Result Toxicity Limit

(Toxicity Units-TU)

Complies with Limit

48h EC50 to Daphnia Magna <1 <10 TU Yes

Note: Sample Date: 12-December 2017.

2.2.2 Interpretation of Emissions to Sewer Data (SE1) All 2017 laboratory analysis results for trade effluent emissions were below licence limits. Trade effluent flowrate compliance was 100%. All quarterly monitoring results continue to be significantly below relevant Emission Limit Values (ELV’s) with no parameter greater than 40% of the licence limit. EPA monitoring at SE1 was conducted on the 9-January 2017 with no measured parameter greater than 4.4% of the associated licence limit. Annual toxicity testing was completed for SE1 by Enterprise Environmental on the 12th December 2017 with results significantly below the sites licence limit. Respirometry testing could not be completed in 2017 as Clonmel WWTP (Irish Water) refused access to their plant to allow collection of a sludge sample. This issue was caused by Irish Water placing a restriction on all such works until a new legal agreement covering this work had been agreed. This agreement has since been finalised and Respirometry testing will resume in 2018. Note: Respirometry has been completed every year since 2009 and in each case it have been shown that Abbott’s Trade Effluent is suitable for treatment causing no adverse impact on the WWTP’s activated sludge (microbes). Annual heavy metals analysis identified metal levels in trade effluent at less than 40% of the limit, approximately 50% of this result is due to metals already present in the incoming towns water. The site expects the current high level of compliance with respect to this aspect to continue during 2018.

BOD5 100%

BOD Load 100%

COD 100%

COD Load 100%

Suspended Solids 100%

Suspended Solids Load 100%

Phosphate 100%

Phosphate Load 100%

Sulphate 100%

Sulphate Load 100%

Fats, Oils & Greases 100%

Fats, Oils & Greases Load 100%

Total Heavy Metals 100%

25

3

1.5

18

20

9

28

<40

Parameter

13

31

25

10

3

2017

IPPCL %

Compliance0 25 50 75 100

Max Result

(as % of EPA Limit)


2.3 Emissions to Surface Water

2.3.1 Emissions to Surface Water Overview

A summary of 2017 emissions to surface water are included in Table 2.3.1 below. Sampling of emissions was conducted in accordance with Schedule C.2.3 of the Licence for the sites licensed emission point, SW-1. Monthly surface water monitoring was completed by ANUA (Bord Na Mona) and Eurofins Labs with weekly testing completed by Abbott. A summary of surface water analysis results is shown in the table below. Table 2.3.1, Summary of 2017 Emissions to Surface Water

Emission Point

Parameter Monitoring Frequency

2017 Results

2017 Results Average

SW1

Visual Inspection Weekly Normal n/a

pH min-max range Weekly 6.31 – 8.22 6.95

Conductivity (mg/l) Monthly 355 - 639 515

Parameter Monitoring Frequency

2017 Range Average Jan-Dec 2017

COD (mg/l) Monthly <10 – 23 17.1

2.3.2 Interpretation of Surface Water Data

Weekly pH testing and visual inspections have not identified signs of surface water contamination during 2017. Chemical Oxygen Demand (COD) results have returned to normal levels following the two elevated readings recorded in April and May 2016.

2.4 Waste Management

2.4.1 Waste Management Overview In accordance with Condition 11 of our licence, Abbott maintains full records of all waste streams arising from site activities.

Disposal and recovery routes for each waste stream and permit/licence details for all waste contractors used are outlined in the AER Returns Worksheet submitted electronically by uploading to the EPA Website as required by the Licence. A copy of the AER Returns Worksheet has also been included in this document, see Appendix A.


Table 2.4.1 (a), Summary of 2017 Waste Collections

Table 2.4.1 (b), 2017 Non-Hazardous Waste Collections

Waste 2016 (Tonnes) 2017 (Tonnes)

Total Waste Collections 601.836 710.01

Total waste disposed 55.314 105.30

Total waste recycled 442.853 479.506

Total waste recovered 103.8 125.206

Total Waste Recycling % 73.6% 67.5%

Non-Hazardous Waste Collections 507.62 544.693

Non-Hazardous waste recovered 67.45 65.92

Non-Hazardous waste recycled 440.17 478.773

Non-Hazardous Waste Recycling % 86.7% 87.9%

Hazardous Waste Collections 94.347 165.32

Hazardous waste disposed 55.314 102.80

Hazardous waste recovery 36.35 61.786

Hazardous waste recycled 2.683 0.733

Hazardous waste recycle & recovery % 41.37% 37.8%

Waste Type EWC Code 2017 (Tonnes)

Toners 08 03 18 0.28

Cardboard 15 01 01 69.10

Plastic 15 01 02 2.53

Mixed Recycle 15 01 06 194.64

Antifreeze 16 01 15 1.6

Carpark Trap (Water/Trace Oil) 16 10 02 2.5

Glass 17 02 02 4.9

Confidential Paper 20 01 01 32.05

Compost 20 01 08 42.65

Greasetrap Waste 20 01 25 37.24

Canteen Oil 20 01 25 2.7

Wood 20 01 38 67.20

Metals 20 01 40 13.38

MSW Waste (SRF) 20 03 01 61.82

C&I 20 03 07 12.10

2017 Non-Hazardous Waste Total: 544.69


Table 2.4.1(c), 2017 Hazardous Waste Collections

Waste Type EWC Code 2017 (Tonnes)

Electroglo 300 (Acidic Electropolish) 06 01 01* 1.018

Hydrochloric Acid 06 01 02* 0.189

Nitric Acid 06 01 05* 0.776

Other Acids (Vision Polish) 06 01 06* 46.388

Organic solvents and mother liquors 07 05 04* 24.66

Solid waste containing dangerous substances 07 05 13* 22.887

Waste Adhesives 08 04 09* 0.783

Waste Oil 13 02 08* 1.2

Packaging containing dangerous substance residues 15 01 10* 25.497

Adsorbents and filters containing dangerous substances 15 02 02* 36.168

Waste Electrical Equipment 16 02 15* 0.495

Waste Glycol 16 05 08* 4.806

Biological Medical Waste 18 01 03* 0.2166

Lamps 20 01 21* 0.238

2017 Hazardous Waste Total: 165.32

Some minor waste streams reported in 2016 do not appear in the 2017 report as they were produced late in 2017 and were not collected for disposal until early 2018. These streams will be reported as part of the sites 2018 submission.

2.4.2 Interpretation of 2017 Waste Data

The waste details outlined in Tables 2.4.1 (a, b & c) above represents all waste collections from the Clonmel site during 2017. The site recorded an absolute total waste increase during 2017 of 18% due to production and headcount increases and a number of exceptional (once off) waste events (eg, significant hazardous waste carry over from last quarter 2016 into 2017, offsite warehouse cleanouts.) 2017 total waste is down by 1% on a production normalised basis. The site again during 2017 sent no waste to landfill and continues to focus on diverting hazardous wastes from disposal to recovery (waste to energy). Table 2.4.2(a), 5-Year Total Waste Reduction Goal Tracking (15% Absolute Reduction by 2018)

Aspect 2014 2015 Actual 2016 Actual 2017 Goal 2018 Goal

Total Waste Baseline

Year -13%

v 2014 -12.5% v 2014

+4% v 2014

-15% v 2014

At the end of 2017 total waste versus 2014 on a production normalised basis is down 15%. Waste Recycling and Recovery Summary: Abbott maintains detailed waste handling procedures and comprehensive waste segregation facilities to promote high levels of onsite waste segregation. The site audits waste segregation compliance and tracks waste recycling percentages. Total waste recycle in 2017 saw a decrease from 73.6% to 67.6% owing largely to a significant increase in hazardous waste collections during 2017. Total waste recycled and recovered saw a decrease from 90.8% to 85.2% for the same reason.


Table 2.4.2 (b), Non-Hazardous Waste Recycling Percentage (2009-2017)

Hazardous Waste Summary: The site recorded an increase in 2017 hazardous waste collections of 77.1% due to production increases and a large volume of waste generated in Q4 2016 being disposed of in 2017. The site has taken corrective action to ensure that wastes generated in one year are collected in the same year. Table 2.4.2 (c), Annual Hazardous Waste Collections (Metric Tonnes) (2008-2017)

During 2018 the site is focused on minimising increases in total waste whilst increasing production output and headcount.


2.5 Resource Consumption A summary of site energy and water consumption for 2017 is presented below.

Energy Consumption & CO2 Emissions

2.5.1(a) 2017 Primary Energy Consumption: Overall primary energy usage (Gas & Electricity) decreased by 4.5% following the completion of energy reduction projects during 2017. Table 2.5.1(a), 2017 Primary Energy Consumption kWhr (Absolute)

Aspect 2016 2017

Primary Energy (Gas & Elec) 60,596,400 57,862,417 (-4.5% v 2016)

Diesel (Litres) 200 510

Table 2.5.1(b), 5-Year Primary Energy Reduction Goal Tracking (5% Absolute Reduction by 2018)

Aspect 2013 2014 Actual 2015 Actual 2016 Actual 2017 Actual 2018 Goal

Primary Energy (Gas & Elec)

Baseline Year

+1.9% v 2013

- 2% v 2013

-3.44% v 2013

-8% v 2013

-5% v 2013

2.5.2 2017 Electrical Consumption: Total electrical consumption on site reduced by 3.6% as a result of reduced demand linked to a number of energy reduction projects during 2017. Table 2.5.2(a), 2017 Electricity Consumption (Absolute)

Site Electricity Usage 2016 – 2017 (kWhr)

Energy Stream Annual Quantity 2016 Annual Quantity 2017

Electricity Imported 13,524,436 13,476,120

Electricity Generated Onsite (CHP) 9,117,680 8,340,990

Total Electricity Consumed Onsite 22,642,116 21,817, 110 (-3.6%)

2.5.3 2017 Natural Gas Consumption Gas consumption for the site reduced by 9.8% as a result of a CHP Demand-Off Agreement with the grid. Table 2.5.3 (a), 2017 Natural Gas Consumption (Absolute)

Energy Stream Annual Quantity 2016 Annual Quantity 2017

Natural Gas for CHP 22,786,486 20,822,158

Natural Gas Total 26,785,310 24,172,117 (-9.8%)

2.5.4 2017 CO2 Emissions Site CO2 emissions reduced by 41% as a result of a 4.5% reduction in actual primary energy usage and a move to 100% of the sites imported electricity now being generated from renewable sources via SSE Airtricity.

Table 2.5.4 (a), 2017 CO2 Emissions

Aspect 2016 2017

CO2 (Kg) 8,385,032 4,943,198 (-41% v 2016)


2.5.5 2017 Towns Water Consumption Towns water consumption decreased by 1.9% during 2017 despite increases in headcount and production, the sites greywater recycling system installation has experienced some delays with commissioning due to be completed in the first half of 2018. Table 2.5.5 (a), 2017 Water Consumption (Absolute)

Aspect 2016 2017

Water (m3) 48,180 47310 (-1.9% v 2016)

Table 2.5.5(b), 5-Year Water Reduction Goal Tracking (15% Absolute Reduction by 2018)

Aspect 2013 2014 Actual 2015 Actual 2016 Actual 2017 Actual 2018 Goal

Water (m3) Baseline

Year +6.7% v 2013

+21.2% v 2013

+9.4% v 2013

+7.5% v 2013

-15% v 2013

Water usage at the end of 2017 versus 2013 is down 20% on a production normalised basis.

2.6 2017 Environmental Incidents & Complaints

2.6.1 IPPC Licence Exceedances There were no licence exceedances during 2017.

2.6.2 EPA Reportable Incidents There was one EPA reportable incident during 2017. Table 2.6.1(a), EPA Reportable Incidents

Incident Type Date Status

None N/A N/A

2.6.2 General Public Complaints

No environmental complaints were received from the general public during 2017. The site has not received an environmental complaint of any type in the last 12 years.

Table 2.6.2 (a), General Public Complaints

Year 2006 - 2017 2017

Complaints 0 0

2.7 EPA Monitoring and Enforcement

2.7.1 EPA Site Inspections Abbott received one EPA Inspector site visit on the 16th August 2017, no licence non-conformances were raised during this visit.

2.7.2 EPA Environmental Emissions Monitoring The following table summarises on-site emissions monitoring undertaken by the Agency during 2017.

Table 2.7.2(a), Agency Emissions Monitoring 2017

Monitoring Type / Number of Visits Monitoring Date Non-Compliances

EPA Trade Effluent Sampling Visits: 1 9-Jan 2017 None


3.0 Management of the Activity

3.1 Environmental Management Programme (EMP)

3.1.1 2017 EMP Report The site targeted completion of 24 individual tasks under it’s 2017 Environmental Management Program, 22 were completed during the year. Full 2017 program details are provided in Appendix B.

3.1.2 2018 EMP Proposal Abbott’s 2018 Draft Environmental Management Program has been prepared and is included in this document (Appendix C) for the Agencies review and approval.

3.2 Pollution Release and Transfer Register (PRTR)

3.2.1 Pollution Release and Transfer Register Report 2017 Under the European Pollutant Release and Transfer Register Regulation (EC) No. 166/2006, and subsequently the site’s Licence, Abbott are required to annually report emissions of relevant substances and wastes to the EPA. Abbott reviewed all PRTR pollutants (Annex II, EC Reg’s No. 166/2006) to determine the pollutants relevant to Abbott’s activities. The PRTR substances identified as being emitted from the site and reported in the PRTR for 2017 are detailed in Table 3.2.1 below. Table 3.2.1(a), 2017 PRTR Chemical List

Pollutant No. Pollutant Description

2 Carbon Monoxide

3 Carbon Dioxide

4 Hydro-fluorocarbons (HFCs) - HFC134A

7 NMVOC’s

8 Nitrogen Oxides (NOx/NO2)

11 Sulphur Oxides (SOx/SO2)

17-24 Metals

35 Dichloromethane (DCM)

58 Chloroform

80 Chlorine and inorganic compounds (as HCL)

Other pollutants which are outlined in the Licence are also tracked and reported. The quantities emitted have been reported on the AER Returns Worksheet and submitted electronically by uploading to the EPA website as required by the sites IPPC Licence. A copy of the AER Returns Worksheet has also been enclosed as Appendix A. In addition, a copy of the PRTR has been submitted to the Water Services Authority (South Tipperary County Council) as required by the sites IPPC Licence.

3.2.2 2018 PRTR Proposal

The list of substances to be tracked and reported for 2018 sees one change from the 2017 PRTR Chemical List. Chloroform will not be used for R&D purposes during 2018.


4.0 Licence Specific Reports

4.1 Environmental Noise Monitoring Report

4.1.1 2017 Noise Monitoring Data Overview

An environmental noise assessment was conducted 10 – 12th July 2017 by Abbott Global Environmental, Health & Safety. Monitoring and measurements were completed according to the guidance contained within the agency Guidance Note for Noise: Licence Applications, Surveys and Assessments in Relation to Scheduled Activities (NG4).

Table 4.1.1(a) 2017 Environmental Noise Monitoring – Noise Sensitive Locations (NSL’s)

Location

Day/ Night

LAeq dB(A)

LA90 dB(A)

Tonal Noise

LAr,T

Comments

NSL1 Day 56 45.3 No 56.0 • All LAF90 values are significantly below IPPC licence limits.

• The LAr values are above IPPC licence limits.

• There is no tonal noise or impulsive characteristics coming from the

Abbott Vascular site at NSL1 and NSL2.

NSL1 Day 55.3 46.5 No 55.3

NSL1 Day 55.2 45.6 No 55.2

NSL1 Night 46.3 34.4 No 46.3

NSL1 Night 45.1 33.5 No 45.1

NSL2 Day 64.1 45.7 No 64.1

NSL2 Day 64.5 46.9 No 64.5

NSL2 Day 64.7 46.6 No 64.7

NSL2 Night 57.1 32.0 No 57.1

NSL2 Night 53.8 28.9 No 53.8

Table 4.1.1(b), 2017 Environmental Noise Monitoring - Site Boundary Monitoring

Location Day/ Night

LAeq dB(A)

LA90 dB(A)

Tonal noise

LAr,T

Comments

N1 Day 59.5 50.7 No 59.5 • At N1 LAr values (based on LAeq obtained) are above the limits. This

is caused by the close proximity (30 m approx.) of the sampling

point to the R688 route where heavy road traffic occurs. The LA90

value is a more representative figure to express the noise from

Abbott because it filters out loud, intermittent interferences such as

traffic noise. All LA90 levels were well below the limits at N1.

• At N2, night time noise levels were above the night time limit of 45

dBA and the CUB was the dominant noise source. One night-time

noise measurement result also had a tonal component at 1600 Hz

detected by 1/3 octave analysis. This tonal component was not

present in any other results for N2 and other sampling locations in

this survey. All N2 daytime values were consistently well below the

IPPCL limit of 55dBA without any tonal component.

• At N4, most LAr values (based on LAeq obtained) exceed the limit

while the remaining result was below the relevant limit. This is

primarily caused by road traffic on the R688 with little contribution

from site traffic because N4 location is also very close to the R688

and the main site exit. The LA90 values are a more representative

figure to express the noise from Abbott Vascular at specific points

because it filters out loud, intermittent interferences such as traffic

noise. All LA90 values recorded for daytime and night time were

significantly within the IPPCL limits for day and night time.

N1 Day 58.3 49 No 57.4

N1 Day 56.6 48.2 No 56.6

N1 Night 57.3 40.6 No 46.0

N1 Night 52.1 38.1 No 44.4

N2 Day 48.6 46.6 No 48.6

N2 Day 50 47.2 No 50.0

N2 Day 51.6 48.1 No 51.6

N2 Night 43.5 40.3 No 43.5

N2 Night 49.2 45.5 No 49.2

N2 Night 49.6 48.6 No 49.5

N4 Day 56.5 45.5 No 56.5

N4 Day 57.4 48.8 No 57.4

N4 Day 56.6 48.6 No 56.6

N4 Night 46 38.9 No 46

N4 Night 44.4 38.1 No 44.4


4.1.1(c) 2017 Noise Monitoring Location Map

Notes:

Boundary noise measurement points: N1, N2, N4. Noise Sensitive Location measurement points: NSL1, NSL2. Nearest noise sensitive location:

4.1.2 Interpretation of 2017 Noise Monitoring Data

a) Noise Levels at Nearest Noise Sensitive Locations (NSL’s) The nearest NSL to the site is a private dwelling situated 200 meters to the north east of the site boundary, (see on plan above). The Clonmel to Cashel Road (R688) divides the site from this dwelling with the road passing directly in front of the house. NSL1 and NSL2 monitoring point readings taken adjacent to this dwelling were found to exceed the daily and night environmental noise limits. LA90 readings were also taken and indicate that the predominant noise contribution is from road traffic on the R688 Clonmel-Cashel main road. No audible or tonal noise was identified at noise sensitive monitoring locations. b) Boundary Noise Levels No audible or repeatable tonal noise was identified at the site boundary. Noise at N1 and N4 are mainly influenced by road traffic from the R688 (Clonmel to Cashel Road).

In summary, Abbott Vascular does not give rise to noise levels that cause nuisance to it’s neighbours and has received no noise complaints during 2017. In fact the Abbott site has not received a single noise related compliant since operations commenced in 2006.

N1

N4

N2

NSL1

NSL2

R688

Boston Scientific

Abbott Vascular

Business Park R688


4.2 2017 Solvent Management Plan

4.2.1. Introduction

A Solvent Management Plan (SMP) is required to be submitted for each calendar year. A SMP for 2017 has been prepared based on a mass balance approach and taking into account the guidelines outlined in Annex III of the Solvents Directive. Solvents in use at Abbott are:

• Acetone

• Isopropyl Alcohol (IPA)

• Cyclohexanone

• Heptane

• Dichloromethane (DCM)

• Methanol

• Acetonitrile

• Chloroform

On Site Solvent Storage Facilities

4.2.2. 2017 Site Solvent Mass Balance As part of the sites annual environmental report the site completes an annual mass balance of solvent usage on site. The site over the last eight years has implemented a range of projects to minimise solvent use at a time of significant production growth. Production increases have resulted in total site solvent usage increasing by 12% during 2017. The bulk of the sites solvent usage is for general cleaning, laboratory usage and solvent cleaning operations associated with coating. The figures shown for coating solvent in Table 4.2.2 (b) represent solvent used for actual coating and solvent cleaning associated with coating. Table 4.2.2 (a), 2017 Solvent Consumption Summary (Absolute)

Aspect 2016 2017

Total Solvent Usage 26,347 29,601 (+12% v 2016)

4.2.2(b) Coating & Total Site Solvent Usage History (Kg)


A site mass balance of all solvent inputs and outputs during 2017 has been performed with the detail outlined on Page 21, Table 4.2.2(c). Table 4.2.2(c) Mixed Solvent Waste Analysis

Parameter Average %

IPA 35.0

Acetone 25.0

Acetonitrile 6.0

Cyclohexanone 0.3

Heptane 0.5

Dichloromethane, Methanol, Chloroform 0.0

Water Content 33.2

ND - None detected.

4.2.3. Discussion on 2017 SMP Result - Assessment of compliance with VOC Fugitive Emission Limit

The mass balance shown below in Table 4.2.2(c) identifies unaccounted for (fugitive) emissions to be 13.8% of the sites total solvent usage during 2017. This figure is compliant with the 20% limit set by the sites IPPC Licence.

4.2.4. Solvent Usage & Fugitive Emissions Reduction Update

As a medical device manufacturer solvent usage for cleaning activities plays a critical role in ensuring patient safety. As a result the site often has limited scope to make radical changes if in doing so might reduce the effectiveness of cleaning. The site will continue to investigate operational improvements to minimise solvent spillages and unnecessary solvent evaporation. Baseline solvent emissions monitoring was completed for the sites new Vessel Closure manufacturing unit in 2017, however planned production changes will require additional monitoring to be completed in 2018 with a full report submitted to the agency on completion of 2018 monitoring.

4.2.5. Solvent Recovery, Reuse & Substitution Given the nature of the sites strictly regulated manufacturing processes there are limited options open to Abbott with regards to on-site solvent recovery and reuse. A common requirement for the medical device industry is the significant use of solvents for cleaning of medical device parts and clean down of manufacturing work stations and equipment. The vast majority of the solvent used for workstation wipe down evaporates to the general work environment and is non-recoverable. The solvents used by Abbott are those most suitable for use with medical devices and therefore it is not feasible to replace them with less harmful alternatives (i.e. water based solvents.). The site has also examined the feasibility of using solvents of a lower strength (i.e. 50% Acetone) but they proved ineffective in providing the degree of cleaning efficacy required.


Table 4.2.2 (c) 2017 Site Solvent Mass Balance

Component Methanol IPA Acetone DCM Chloroform n-Hexane Cyclohexanone Heptane Acetonitrile TOTAL (Kg)

I1 – Inputs 213.0 15620.1 12010.4 40.5 0.0 0.0 399.0 297.6 1020.5 29601.1

I2 – Internal recycle (N/A) 0 0 0 0 0 0 0 0 0 0

I - Total Input 213.0 15620.1 12010.4 40.5 0.0 0.0 399.0 297.6 1020.5 29601.1

O1 Solvent emissions in Waste Gases 0 655 2665 0 0 0 57.7 0 0 3379

O2 Solvents lost in Water (SE1) 0 31 442.00 0 0 0 0 0 0 472.50

O3 Solvents residue on Product (N/A) 0 0 0 0 0 0 0 0 0 0

O5 Solvent Treated or Reacted (Carbon Filters) 0 110 129 0 0 0 56 0 0 295

O6 Collected Waste Solvent 0 1609 0 0 0 0 0 0 0 1609

O7 Solvent for sale as a product (N/A) 0 0 0 0 0 0 0 0 0 0

O8 Solvent for reuse elsewhere 0 10360 7400 0 0 0 79 147 1776 19763

O9 Solvent released in other ways (N/A) 0 0 0 0 0 0 0 0 0 0

O-Total Output 0.0 12764.9 10636.8 0 0 0 192.8 147.1 1776.1 25518

O4 Fugitive Emissions/ Unaccounted For 213.0 2855.2 1815.6 40.5 0.0 0.0 206.2 150.5 -756 4083.40

13.8Total Fugitive (Loss to Air) %:


The sources of data used for each input and output to complete the sites solvent mass balance are outlined below (these reflect the terminology used in the Solvents Directive): Solvent Inputs (I): I1 - Solvent Inputs – the amount of fresh solvent consumed on site during 2017 was calculated from data obtained from the sites Supply Chain Solvent Usage Tracker, solvent supplied by VWR (VMI) and solvent ordered directly via the sites electronic purchasing system (Xiam). I2 – Internal Recycle – no recovered solvent is reused onsite, virgin solvent is used for all coating and cleaning operations. Solvent Outputs (O): O1 - Solvent Emissions in Waste Gases. Figures calculated from quarterly monitoring data of main emissions points which were operational during 2017: A2-1, A2-2, A2-3, A2-4, A2-5, A2-7 and A2-8. Solvents emissions from the Hazmat area were included based on historic monitoring data. There are no other point source emissions on site likely to give rise to detectable levels of VOC’s. O2 - Solvents Lost in Water. This has been calculated from annual solvent monitoring of SE1 (Trade Effluent) and the total trade effluent flow for 2017. O3 - Solvents Residue on Product – cardiac stents are implantable medical devices and therefore contain no residual solvent on the product. O5 - Solvent Treated or Reacted (Absorbed or incinerated) – calculated based on an estimate of the quantity of Solvent used as part of the Primer Spray process which is captured on an activated carbon filter. This process uses a Labcaire ductless fumehood fitted with carbon filters. O6 - Collected Waste Solvent – Waste containing solvent sent off site for disposal (as opposed to recovery) includes solvent soaked wipes used for cleaning with IPA. Solvent which is sent for reuse/recovery is classed under O8 (Solvent Reused/Recovered Off-Site) below. O7 - Solvent for Sale as a Product - This term does not apply to the Abbott site. O8 - Solvent for Reuse elsewhere – this includes waste from Abbott which is sent off-site for recovery as the definition of recovery for reuse under the legislation is ‘the use of organic solvents recovered from an installation for any technical or commercial purpose and including use as a fuel’. IBC’s of solvent waste for recovery offsite are analysed for solvent content, this data is used as a basis to estimate the breakdown of all waste solvent sent off site for recycling. O9 - Organic Solvents released in Other Ways - This term is not relevant to the Abbott site.

O4 - Fugitive Solvent Emissions – fugitive emissions have been calculated based on solvent mass balance difference, i.e., the unaccounted value. In addition, solvents lost in water (O2) and solvent residue on product (O3) are required to be counted as fugitive emissions. Hence, the unaccounted value resulting from the mass balance, plus O2 and O3, has been taken as the level of fugitive solvent emissions from the site. Fugitive/Unaccounted Losses = I1+I2 – (O1+O2+O5+O6+O8) Spillages/Incidents: There were no significant spillages/incidents involving solvent during 2017.


4.3 Energy Efficiency Auditing Introduction The last comprehensive site energy audit was completed by Project Management (PM) in March 2015 with the next audit scheduled for 2019. A Corporate energy usage review is scheduled for 2018 together with a gap analysis for the Energy Management Standard ISO50001.

Site Energy Management System Overview Site headcount recorded at the end of 2017 was 1,401 people working onsite. The facility operates on a 5 day, 2 x 8 hour shift basis, occasionally there is overtime on Saturdays between 7am – 1pm. The current energy management system includes the following:

• Electrical consumption data is provided by Airtricity. A detailed breakdown of site energy consumption is available via the new onsite Energy Management System (EFT) with over 100 energy meters installed on site.

• Gas consumption data is provided by ESBI through monthly billing. The onsite BMS also records gas consumption data for the site and for the Combined Heat & Power plant (CHP).

• Data from EFT and the Building Management System (BMS) is used to produce usage trends for the key energy users on site, eg, HVAC, Chilled Water, Lighting, 208 Voltage System, Compressors and General Services.

The site completes periodic site energy audits to identify opportunities for energy reduction. A history of relevant energy reviews completed at the Clonmel site is shown below:

• Project Management (PM) Energy Assessment March 2015.

• Electric Ireland Site Energy Review, September 2014.

• Abbott Global Energy Management (GEM), April 2014.

• Chilled Water System Review, September 2011.

• Low Pressure Hot Water System Review 2011.

• Site Energy Survey, Dec 2009.

• Chilled Water Survey Report (Johnson Controls/Retrofit Services), Aug 2008.

• HVAC Energy Savings Audit Report (Curley Smith Design Ltd), Nov 2007.

• Sustainable Energy Ireland (SEI) Audit, Sept 2007.

• Abbott Global Energy Group (GEM) Energy Audit, July 2007.

Energy improvement projects identified from the above audits and/or reviews are tracked via the sites register of energy reduction opportunities with individual projects tracked via the sites annual Environmental Management Program (EMP). Projects completed in 2017 and planned for 2018 are detailed within the EMP updates provided in Appendices B & C of this document.

4.4 Decommissioning Management Plan (DMP) Review

The last DMP/CRAMP revision was submitted to the agency on the 31-March 2016 with EPA approval of the document received on the 6-July 2016.

4.5 Environmental Liabilities Risk Assessment (ELRA) Review The last ELRA revision was submitted to the agency on the 31-March 2016 with EPA approval of the document received on the 6-July 2016.


4.6 Statement of Measures

A statement of measures in relation to prevention of environmental damage and remedial actions (Environmental Liabilities) is required to be submitted in the AER. The Abbott Corporation will act as guarantor for all future environmental liabilities arising at the Clonmel site. Environmental liabilities on site will continue to be controlled as outlined in the current ELRA. Abbott Ireland issued a third party bond to the EPA covering all the Abbott sites in Ireland, confirmation of EPA Approval for this financial provision was received on the 13-Sep 2017.

4.7 Testing of Underground Tanks, Sewer Pipes and Bunds

In accordance with Condition 6.10 of the sites licence three yearly testing and inspection of all trade and domestic sewage pipelines was completed in 2017 with required corrective actions addressed on a prioritised basis. Testing included both camera surveying and hydrostatic pressure testing. Three yearly testing and inspection of bunds was also completed during 2017.

4.8 Waste Prevention, Minimisation and Recycling Summary The site is currently experiencing significant production and headcount growth which makes it very difficult to reduce absolute total waste volumes year on year. The site continues to see waste reductions on a production normalised basis. The vast majority of processes on site are mature with most of the feasible waste reduction improvements already implemented. The site recycles the vast majority of its non-hazardous waste and non-hazardous materials that cannot be recycled (general waste) is sent for recovery (Solid Refuse Fuel). Opportunities for recycling of hazardous waste are limited but the site has made significant progress in diverting waste streams from disposal to recovery (Waste to Energy, Indaver Meath).

4.9 Raw Material Usage and Efficiency One of the key elements of the sites Operational Excellence Program is the focus on Lean Manufacturing. Key metrics are maintained for all manufacturing lines to minimise scrap and maximise material usage efficiency. Abbott Corporate during 2018 will complete continuous improvement reviews covering water and energy usage and waste generation.

4.10 Minimisation of Water Demand and Trade Effluent Water usage decreased in 2017 by 1.9% with commissioning of the sites greywater collection system due for completion in the first half of 2018.

4.11 Long Range Environmental Improvement Goals (2014-2018)

The site has set the following long range goals covering the period 2014 to 2018.

Aspect 2018 Long Range Goal Currently Tracking

(End of 2017)

Primary Energy (Absolute) Reduce primary energy by 5%. Down 8%

CO2 (Absolute) Reduce CO2 by 15%. Down 62.2%

Total Waste Reduction (Absolute) Reduce total waste by 15%. Up 4%

Water Conservation (Absolute) Reduce water usage by 15%. Up 9%


4.12 Submitted Reports 2017

The following reports were submitted in full to the EPA during the year:

• 2016 Annual Environmental Report (AER), 31-Mar-17.

• 2016 Pollutant Releases & Transfer Register (PRTR), 31-Mar-17.

4.13 Document History • Document uploaded to Eden on 31-March 2018.

• Document re-submitted on 15-May-18 to address minor errors to Table 2.1.1 c


APPENDIX A – PRTR Returns Worksheets

REFERENCE YEAR 2017

1. FACILITY IDENTIFICATION

Parent Company Name Abbott Ireland

Facility Name Abbott Ireland (Vascular Division) (Clonmel)

PRTR Identification Number/Licence Number P0847 / P0847-01

Classes of Activity

No. class_name

- Refer to PRTR class activities below

Address 1 Vascular Division

Address 2 Cashel Road, Lawlesstown, Clonmel, Tipperary

Coordinates of Location -7.72183 52.3729

River Basin District IESE

NACE Code 3250

Main Economic Activity Manufacture of medical and dental instruments and supplies

AER Returns Contact Name Nigel Hickey

AER Returns Contact Email Address [email protected]

AER Returns Contact Position Environmental Coordinator

User Feedback/Comments Increases in BOD, COD and FOG caused by trade discharges during maintenance of the sites chilled water system.

Differences in trade effluent: Suspended Solids, Metals, Sulphate, Solvents and Phosphates caused by normal

sampling variation. Waste increases caused by increases in production, headcount and once off carry forward of

waste from 2016 into 2017. Significant reduction in COD to Water caused by remedial works implemented following

issues seen in 2016. Changes in TOC emissions caused by production increases and normal monitoring variation.

Significant reductions in COD emissions caused by all 2017 imported electricity being now sourced from

renewables. Reduction in fugitive solvent emissions caused by more accurate calculation of solvent outputs.

2. PRTR CLASS ACTIVITIES

Activity Number Activity Name

50.1 General

3. SOLVENTS REGULATIONS (S.I. No. 543 of 2002)

Is it applicable? No

4. WASTE IMPORTED/ACCEPTED ONTO SITE

Do you import/accept waste onto your site for on-

site treatment?

No


5.1 Releases To Air 2017

SECTION B : REMAINING PRTR POLLUTANTS

Main

Emission

Points

(A2-1, A2-

2, A2-7,

A2-8)

New

Vessel

Closure

Emission

Points

(A2-3, A2-

4, A2-5)

Boilers

(A3-3, A3-

4, A3-5)

and CHP

(A3-19)

Minor

Emission

Point A3-

13,

Hazmats

Minor

Emission

Point A3-

11

Implants

Main

Emission

Points

(A2-6) Not

In Use

No.

Annex II Name 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/Year

07

Non-methane volatile

organic compounds

(NMVOC) C MAB

MAB and EN12619

USEPA Method 26

(modified). SMP for

fugitive levels.

Measurement for main

emissions points. 2723.1 570.3 0.0 85.1 0.0 0.0 7461.5 0.0 4083.0

80

Chlorine and inorganic

compounds (as HCl) M CRM

FTIR Analysis using

ASTM D6348-03 0.0 0.0 0.0 0.0 117.0 0.0 117.0 0.0 0.0

35 Dichloromethane (DCM) C MAB

SMP: Input minus

recovered waste. 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0

02 Carbon monoxide (CO) M

EN

15058:2004

Using SEAI Gas

Conversion Factor

2016: 204.7gCO2/kWhr 0.0 0.0 22043 0.0 0.0 0.0 22043 0.0 0.0

03 Carbon dioxide (CO2) C OTH 0.0 0.0 4948032 0.0 0.0 0.0 4948032 0.0 0.0

08 Nitrogen oxides (NOx/NO2) M

EN

14792:2005 0.0 0.0 13332 0.0 0.0 0.0 13332.0 0.0 0.0

11 Sulphur oxides (SOx/SO2) M

EN

14791:2005 0.0 0.0 6390 0.0 0.0 0.0 6390.0 0.0 0.0

04 Hydro-fluorocarbons (HFCs) E OTH 0.0 0.0 0 0.0 0.0 0.0 128.0 0.0 128.0

QUANTITY

A2-1 A2-2 A2-7 A2-8

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/Year

A

(Accidental)

KG/Year

F (Fugitive)

KG/Year

337 Pharmaceutical actives M ALT EN13284-1:2002 0.004 0.002 0.004 0.003 0.013 0.0 0.0

RELEASES TO AIR

POLLUTANT METHOD

Method Used

QUANTITY

SECTION C : REMAINING POLLUTANT EMISSIONS

A (

Acc

ide

nta

l) K

g/Y

ear

RELEASES TO AIR

M/C

/E

F (F

ugi

tive

) K

g/Y

ear

POLLUTANT METHOD

Method Used


5.2 Releases To Water 2017

SECTION A : SECTOR SPECIFIC PRTR POLLUTANTS

QUANTITY

No. Annex II Name M/C/E Method Code Designation or Description

n/a n/a n/a n/a n/a 0.0 0.0 0.0 0.0

SECTION B : REMAINING PRTR POLLUTANTS

QUANTITY

No. Annex II Name M/C/E Method Code Designation or Description

n/a n/a n/a n/a n/a 0.0 0.0 0.0 0.0

SECTION C : REMAINING POLLUTANT EMISSIONS

QUANTITY

SW1

Pollutant No. Name M/C/E Method Code Designation or Description

Emission

Point 1

T (Total)

KG/Year

306 COD M ALT

G/03 Based on APHA 2005, 21ST

Edition, 5220D, Closed Reflux,

colorimetric method. 933.0 933.0 0.0 0.0

RELEASES TO WATERS

POLLUTANT

Method Used

A

(Accidental)

KG/Year

A

(Accidental)

KG/Year

F (Fugitive)

KG/Year

RELEASES TO WATERS

POLLUTANT

Method Used Emission

Point 1

F (Fugitive)

KG/Year

RELEASES TO WATERS

POLLUTANT

Method Used Emission

Point 1

T (Total)

KG/Year

A

(Accidental)

KG/Year

F (Fugitive)

KG/Year

T (Total)

KG/Year


5.3 Releases To Sewer 2017

SECTION A : PRTR POLLUTANTS

QUANTITY

SE1

No.

Annex II Name M/C/E

Method

Code Designation or Description

Emission

Point 1

19 Chromium and compounds (as Cr) M CRM Heavy Metals: G/57 ICP-Ms based on EP Method 200.8 0.08 0.08 0.0 0.0

20 Copper and compounds (as Cu) M CRM Heavy Metals: G/57 ICP-Ms based on EP Method 200.8 0.2 0.2 0.0 0.0

24 Zinc and compounds (as Zn) M CRM Heavy Metals: G/57 ICP-Ms based on EP Method 200.8 0.66 0.66 0.0 0.0

SECTION B : REMAINING POLLUTANT EMISSIONS

QUANTITY

SE1

Pollutant

No. Name M/C/E

Method

Code Designation or Description

Emission

Point 1

303 BOD M CRM G/04 APHA 2005, Method 5210B 2898.2 2898.2 0.0 0.0

306 COD M CRM G/03 APHA 2005 Method 5220D 6266.0 6266.0 0.0 0.0

314 Fats, Oils and Greases M CRM G/032 APHA Method 5520B 325.6 325.6 0.0 0.0

330 Organic solvents M CRM G/14 Based on ASTM Method D3695 472.81 472.81 0.0 0.0

332 Ortho-phosphate (as PO4) M CRM G/67 APHA 2005, 4500-PE 4.8 4.8 0.0 0.0

343 Sulphate M CRM G/67 Konelab 444.1 444.1 0.0 0.0

347 Total heavy metals M CRM USEPA 200.8 3.59 3.59 0.0 0.0

240 Suspended Solids M CRM G/19 APHA 2005, Method 2540B 972.7 972.7 0.0 0.0

F (Fugitive)

KG/Year

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

POLLUTANT METHOD

Method Used

T (Total)

KG/Year

A

(Accidental)

KG/Year

F (Fugitive)

KG/Year

A

(Accidental)

KG/Year

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

POLLUTANT METHOD

Method Used

T (Total)

KG/Year


5.4 Site Transfers of Waste 2017

H az Waste : N ame and

Licence/ P ermit N o o f N ext

D est inat io n F acility

H az Waste :

A ddress o f N ext


M/C

/E

Meth

o

d U

sed N o n H az Waste: N ame and

Licence/ P ermit N o o f

R eco ver/ D ispo ser

N o n H az Waste:

A ddress o f


To Other

Countries 06 01 01 Yes 0.705

Sulphuric acid and

sulphurous acid D9 M Weighed Abroad

Indaver NV,M LAVI/9800000485/M V/BD

Poldervlietweg 5 Haven 550 Antwerp 3

BE-2030 Belgium

Poldervlietweg 5,Haven

550,Antwerp 3,BE-2030,

Belgium

Indaver

NV,M LAVI/9800000485/M V/BD,

Poldervlietweg 5,Haven 550, Antwerp

3,BE-2030, Belgium


550, Antwerp 3, BE-

2030, Belgium

To Other


Sulphuric acid and

sulphurous acid D15 M Weighed Abroad



BE-2030 Belgium


550,Antwerp 3,BE-2030,

Belgium

Indaver

NV,M LAVI/9800000485/M V/BD,

Poldervlietweg 5, Haven 550, Antwerp

3, BE-2030, Belgium


550, Antwerp 3, BE-

2030, Belgium

To Other

Countries 06 01 02 Yes 0.189 Hydrochloric acid D10 M Weighed Abroad



BE-2030 Belgium


550, Antwerp 3, BE-2030,

Belgium

Indaver

NV,M LAVI/9800000485/M V/BD,


3,BE-2030, Belgium


550,Antwerp 3, BE-

2030, Belgium

To Other


Nitric acid and nitrous

acid D15 M Weighed Abroad AVG,IB2234/AVG-GenB-2

BorsigstraBe2, Hamburg,

22113, Germany

AVG ,IB2234/AVG-GenB-2,

BorsigstraBe2, Hamburg, 22113,

Germany

BorsigstraBe2,

Hamburg, 22113,

Germany

To Other


6.1.1 Vision Polishing

Solution D9 M Weighed Abroad


Poldervlietweg 5, Haven 550, Antwerp 3

BE-2030, Belgium

Poldervlietweg 5, Haven

550, Antwerp 3, BE-2030,

Belgium

Indaver NV,

M LAVI/9800000485/M V/BD,


3, BE-2030, Belgium


550, Antwerp 3, BE-

2030, Belgium

Within the

Country 07 05 04 Yes 24.66

Drug (Evero limus)

Solvent Waste R12 M Weighed

Offsite in

Ireland Indaver, W0036-02

Tolka Quay Road,Dublin

Port, Dublin, D1, Ireland

Indaver Ireland Limited, W0036-2,

Tolka Quay Road, Dublin Port, Dublin,

Ireland

Tolka Quay Road,

Dublin Port, Dublin,

Ireland

Within the

Country 07 05 13 Yes 22.887

Solid Waste potentially

contaminated with

trace quantities of drug

Evero limus R1 M Weighed

Offsite in

Ireland Indaver M eath (M E1), W0167-03

Carranstown, Duleek,

M eath, Ireland Indaver M eath (M E1), W0167-03


M eath, Ireland

Within the

Country 08 03 18 No 0.28 Printer Cartridges R13 M Weighed

Offsite in

Ireland

Starrus Eco Holdings Ltd, WFP-KK-14-

0007-02

Unit 15/16,Hebron

Industrial Estate, Hebron

Road, Kilkenny, Ireland

To Other


Waste adhesives and

sealants containing

organic so lvents or

dangerous substances D15 M Weighed Abroad AVG,IB2234/AVG-GenB-2


22113, Germany

AVG ,IB2234/AVG-GenB-2,


Germany

BorsigstraBe2,

Hamburg,22113,

Germany

Within the

Country 13 02 08 Yes 1.2

Other engine, gear and

lubricating o ils R9 M Weighed

Offsite in

Ireland

ENVA,W-184-2 Clonminam Industrial

Estate. Portlao ise, County Laois,

Ireland

Clonminam Industrial

Estate, Portlao ise,

County Laois, Ireland

ENVA,W-184-2, Clonminam Industrial

Estate, Portlao ise, County Laois,

Ireland




Within the

Country 15 01 01 No 69.1

Cardboard & Paper

Bales R13 M Weighed

Offsite in

Ireland


0007-02

Unit 15/16, Hebron



M etho d Used

Lo

cati

on

of

Tre

atm

en

t N ame and License / P ermit

N o . and A ddress o f F inal

R eco verer / D ispo ser

(H A Z A R D OUS WA ST E ON LY)

A ctual A ddress o f

F inal D est inat io n

i.e . F inal R eco very

/ D ispo sal Site

(H A Z A R D OUS

WA ST E ON LY)Waste

Tre

atm

en

t

Op

era

tio

n

Tra

nsfe

r

Desti

nati

on

Eu

rop

ean

Waste

Co

de

Hazard

ou

s

Qu

an

tity

T/Y

ear

Descri

pti

on

of

Waste





H az Waste :

A ddress o f N ext


M/C

/E

Me

tho

d U

se

d N o n H az Waste: N ame and



N o n H az Waste:

A ddress o f


Within the

Country 15 01 02 No 2.53 Plastic Bales R13 M Weighed

Offsite in

Ireland


0007-02

Unit 15/16,Hebron



Within the

Country 15 01 06 No 194.64 M ixed Recyclables R13 M Weighed

Offsite in

Ireland


0007-02

Unit 15/16,Hebron

Industrial Estate,Hebron


To Other


Packaging containing

dangerous substances D10 M Weighed Abroad


Poldervlietweg 5, Haven 550, Antwerp 3

BE-2030 Belgium


550, Antwerp 3, BE-2030,

Belgium

Indaver NV,

M LAVI/9800000485/M V/BD,


3, BE-2030, Belgium


550, Antwerp 3, BE-

2030, Belgium

To Other


Packaging containing

dangerous substances D15 M Weighed Abroad AVG,IB2234/AVG-GenB-2


22113, Germany

AVG, IB2234/AVG-GenB-2,


Germany

BorsigstraBe2,

Hamburg, 22113,

Germany

To Other


Adsorbents and Filters

containing Dangerous

Substances R1 M Weighed Abroad Indaver M eath (M E1), W0167-03


M eath, Ireland Indaver M eath (M E1), W0167-03


M eath, Ireland

To Other


Adsorbents and Filters

containing Dangerous

Substances D10 M Weighed Abroad



BE-2030 Belgium


550,Antwerp 3, BE-2030,

Belgium

Indaver NV,

M LAVI/9800000485/M V/BD,


3, BE-2030, Belgium


550, Antwerp 3, BE-

2030, Belgium

Within the

Country 16 01 15 No 1.6

Antifreeze fluids other

than those mentioned

in 16 01 14 R3 M Weighed

Offsite in

Ireland

ENVA,W-184-2 Clonminam Industrial

Estate . Portlao ise County Laois Ireland




Within the

Country 16 02 15 Yes 0.495

Hazardous

Components removed

from discarded

equipment R13 M Weighed

Offsite in

Ireland

KM K M etals Recycling Limited.,W0113-

04

Cappicur Industrial

Estate,Daingean

Road,Tullamore County

Offaly, R35 NY29, Ireland

KM K M etals Recycling Ltd,W0113-

04,Cappicur Industrial

Estate,Daingean Road,Tullamore Co

Offaly, R35 NY29, Ireland

Cappicur Industrial

Estate,Daingean

Road,Tullamore Co

Offaly,R35 NY29,Ireland

To Other


Discarded organic

chemicals consisting

of or containing

dangerous substances D15 M Weighed Abroad



BE-2030 Belgium


550,Antwerp 3, BE-2030,

Belgium

Indaver NV,

M LAVI/9800000485/M V/BD,


3, BE-2030, Belgium


550, Antwerp 3, BE-

2030, Belgium

Within the

Country 16 10 02 No 2.5

Aqueous liquid wastes

other than those

mentioned in 16 10 01 R12 M Weighed

Offsite in

Ireland

M cBreen Environmental Drain Services

Ltd,WFP-CN-16-001-01

Fairtown, Cavan, Co.

Cavan, Ireland

Within the

Country 18 01 03 Yes 0.2166 Bio logical Waste R3 M Weighed

Offsite in

Ireland

SRCL,W0055-2, 430 Beech

Road,Western Industrial Estate, Naas

Road, Dublin 12, Ireland

430 Beech Road,Western

Industrial Estate, Naas

Road, Dublin 12, Ireland

SRCL, W0055-2, 430 Beech Road,

Western Industrial Estate, Naas Road,

Dublin 12, Ireland

430 Beech Road,

Western Industrial

Estate, Naas Road,

Dublin 12, Ireland

Waste

Tre

atm

en

t

Op

era

tio

n M etho d Used

Lo

cati

on

of

Tre

atm

en








/ D ispo sal Site

(H A Z A R D OUS

WA ST E ON LY)Tra

nsfe

r

De

sti

na

tio

n

Eu

rop

ea

n

Waste

Co

de

Hazard

ou

s

Qu

an

tity

T/Y

ea

r

Descri

pti

on

of

Wa

ste





H az Waste :

A ddress o f N ext


M/C

/E

Me

tho

d U

se

d N o n H az Waste: N ame and



N o n H az Waste:

A ddress o f


Within the

Country 20 01 01 No 32.05 Paper Confidential R12 M Weighed

Offsite in

Ireland


0007-02

Unit 15/16, Hebron



Within the

Country 20 01 02 No 4.9 Glass R13 M Weighed

Offsite in

Ireland


0007-02

Unit 15/16,Hebron



Within the

Country 20 01 08 No 42.64 Compost R13 M Weighed

Offsite in

Ireland


0007-02

Unit 15/16,Hebron

Industrial Estate,Hebron


Within the

Country 20 01 21 Yes 0.238

Fluorescent Tubes and

other M ercury-

containing waste R4 M Weighed

Offsite in

Ireland

Irish Lamps Recycling Co, WFP-KE-14-

0072-01

Woodstock Industrial

Estate, Kilkenny Road,

Athy, Kildare, Ireland

Irish Lamp Recycling,WFP-KE-14-0072-

01,Woodstock Industrial Estate,

Kilkenny Road, Athy, Kildare, Ireland

Woodstock Industrial

Estate, Kilkenny Road,

Athy, Kildare, Ireland

Within the

Country 20 01 25 No 37.24 Grease Traps R4 M Weighed

Offsite in

Ireland

M cBreen Environmental Drain Services

Ltd,WFP-CN-16-001-01

Fairtown, Cavan, Co.

Cavan, Ireland

Within the

Country 20 01 25 No 2.7 Canteen Oil R9 M Vo

lum

e

Ca

lcu

latio

nOffsite in

Ireland Frylite, WFP-G-17-0007-02

Kilco lgan, Co Galway, H91

YK53, Ireland.

Within the

Country 20 01 38 No 67.2 Wood R13 M Weighed

Offsite in

Ireland

Starrus Eco Holdings Ltd,WFP-KK-14-

0007-02

Unit 15/16,Hebron



Within the

Country 20 01 40 No 13.38 M etals R13 M Weighed

Offsite in

Ireland


0007-02

Unit 15/16,Hebron



Within the

Country 20 03 01 No 61.82

M ixed M unicipal Waste

(SRF) R13 M Weighed

Offsite in

Ireland


0007-02

Unit 15/16,Hebron


Road,Kilkenny,Ireland

Within the

Country 20 03 07 No 12.1 C&I (Bulky Waste) R13 M Weighed

Offsite in

Ireland


0007-02

Unit 15/16,Hebron


Road,Kilkenny,Ireland

Tra

ns

fer

De

sti

na

tio

n

Eu

rop

ea

n W

as

te

Co

de

Ha

za

rdo

us

Qu

an

tity

T/Y

ea

r

De

sc

rip

tio

n o

f

Wa

ste

Wa

ste

Tre

atm

en

t

Op

era

tio

n

M etho d Used

Lo

cati

on

of

Tre

atm

en








/ D ispo sal Site

(H A Z A R D OUS

WA ST E ON LY)


APPENDIX B – 2017 EMP Update


2017 Environmental Management Program Report

Aspect Project Description Status

Complete 2017 rol l out of HVAC (ACPH) as per plan (Implants) Completed.

Complete Si te LED Lighting Review & Complete Canteen Upgrades . Completed.

Complete review of EFT KPI Tracking Capabi l i ty Completed.

Complete Rainwater Harvesting System Commiss ioning Delayed to 2018.


Complete Annual Waste Stream Analys is . Completed.

Final ise arrangements for sending Low Level Acid Waste To Indaver Meath. Completed.

Complete Waste Recycle/Reuse Review in Warehouse Area. Completed.

Maintain Zero Waste To Landfi l l Status Completed.

Review Greasetrap Clean Frequency Completed.


Supply Chain Complete Si te Dangerous Goods Safety Advisor (DGSA) Program Review. Completed.


Surface Water Complete review of Spi l l Prevention Technica l Standard and Si te Spi l l

Prevention Arrangements Completed.

Aspect Project Description StatusComplete Vessel Closure VOC Emiss ions Report & Submiss ion to EPA. Delayed to 2018,

see comments

Section 2.1.1

Complete Annual Solvent Mass Balance (For AER) Completed.


Submit 2016 Annual Environmental Report to EPA. Completed.

Submit 2016 Pol lution Release and Transfer Regis ter (PRTR) to EPA. Completed.

Complete ENHESA Environmental Regulatory Review. Completed.

Complete Review of a l l Abbott Environmental Technica l Standards Completed.

Address any Corporate 3-Yearly EHS Audit Environmental Findings Completed.


Complete Internal Audits covering ISO14001 2015 Changes . Completed.

Complete Management Review covering ISO14001 2015 requirements . Completed.

Update Environmental Aspects SOP to include Li fecycle cons iderations . Completed.

Complete Internal Auditor Trans i tion Tra ining. Completed.

Issue new ISO14001 2015 a l igned Environmental Manual . Completed.

Complete ISO14001 Re-Certi fication & ISO14001 2015 Trans i tion. Completed.

Energy &

Resource Usage

Waste

Management

Air Emissions

Compliance

ISO14001 2015

Transition


APPENDIX C – 2018 EMP Proposal


Abbott Clonmel 2018 Environmental Management Programme

2018 Environmental Management Programme Overview:

In accordance with Condition 2.2.2.3 the sites 2018 Environmental Management Programme (EMP) proposal is presented below. The EMP includes Objectives and Targets prepared in accordance with Condition 2.2.2.3.

The EMP for the site has been prepared taking into account the significant environmental aspects identified during an evaluation exercise of each aspect conducted in accordance with ISO: 14001:2015. Specific IPPC Licence related requirements and specific site and/or Abbott Corporate related goals are also included where applicable.

The Aspects identified and evaluated are outlined as follows: -

Aspect 1: Non-Hazardous Waste Aspect 2: Trade Effluent Emissions to Wastewater Aspect 3: Hazardous Waste Aspect 4: Supply Side Activities Aspect 5: Energy and Resource Usage Aspect 6: Emissions to Atmosphere Aspect 7: Hazardous Materials Aspect 8: Contractors Activities Aspect 9: Transport Aspect 10: Surface Water & Non-Trade Effluents Aspect 11: Visual Impact Aspect 12: Environmental Noise Aspect 13: Potential Land Contamination Misc 1: Other Environmental Risks & Opportunities Misc 2: Stakeholders Requirements

The objectives within the sites 2018 EMP were identified from the following:

• A review and re-rating of the sites environmental aspects to identify significant aspects.

• A review of any open actions from the 2017 EMP.

• Identification of any IPPC related actions to be completed during 2018.

• A review of internal environmental audits and compliance reviews.

• Any other site and/or Abbott Corporate specific requirements.

• A review of other risks and opportunities and other stakeholder requirements.

The objectives and targets to be achieved within the EMP are outlined below and include the means and timeframe by which they will be achieved and responsibilities for implementation.

All the major environmental aspects on site have long-term programmes associated with them. These include Energy, Water Conservation and Waste Reduction. The 2018 EMP presents many of the shorter-term actions required to achieve continued environmental improvement and forms part of the sites 5-year long range environmental plan (2014-2018).

2018 Environmental Management Programme


Objective Aspect 2018 Project Description

Complete LED Lighting installation as per plan.

Complete ISO50001 Certification Gap Analysis

1 Complete Rainwater Harvesting System Commissioning

Complete Site Energy Reduction Assessment.

Complete Site Water Reduction Assessment


Complete Annual Waste Stream Analysis.

Complete Canteen Waste Handling/Segregation Review

2 Optimise Greasetrap Clean Frequency

Complete Site Waste Reduction Opportunities Assessment

Complete onsite Contractor Waste Management Refresher Training


3 Surface Water Complete Annual Bund and Storage Tank Risk Assessments.


Complete Vessel Closure VOC Emissions Monitoring Post Line Moves

Complete 2017 Solvent Mass Balance.


5 Hazardous Materials Complete spill detection installation for double skinned external tanks.


Submit 2017 Annual Environmental Report to EPA.

Submit 2017 Pollution Release and Transfer Register (PRTR) to EPA.

Complete Annual ENHESA Environmental Regulatory Review.

Implement improved EHS Document Review Process.

Complete Corporate Environmental Data Accuracy Audit

Conduct EHS Culture Survey.


7 Environmental Noise Complete Environmental Noise Monitoring Training (Site EHS Staff)

Air Emissions4

6 Environmental Compliance

All actions for closure between 1-Jan-18 and 31-Dec 2018.

Energy & Resource Usage

Waste Management

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