EXECUTIVE - Environmental Protection Agency · EXECUTIVE SUMMARY ... 4.2 2015 Solvent Management Plan ... 179.20 89.4 4785 Yes A2-2 Suite No.2 – Mandrel solvent cleaning

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 2015 .......................................................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 2015 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 2015 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) .... 25 4.12 Submitted Reports 2015 ............................................................. 25

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

5.1 Releases To Air 2015 ....................................................................... 27 5.2 Releases To Water 2015 .................................................................. 28 5.3 Releases To Sewer 2015 ................................................................. 29 5.4 Site Transfers of Waste 2015 ........................................................... 30

APPENDIX B – 2015 EMP UPDATE ........................................................33

APPENDIX C – 2016 EMP PROPOSAL ...................................................35

31-March 2016 1 of 42 Annual Environmental Report 2015

EXECUTIVE SUMMARY 2015 was a busy year for the Clonmel site with the site commencing manufacture of the new Vessel Closure range of medical devices. Our employees on-going commitment to continuous improvement and environmental excellence has produced further improvements across a range of key environmental indicators as the site continues to progress towards achieving it’s 2018 long range goals. Total waste generated on site during 2015 reduced by 7.5% with Hazardous waste reducing by 15.2% and non-hazardous waste reducing by 7%. Total waste recycle showed the seventh consecutive year on year increase, with the sites recycle rate moving from 81.5% in 2014 to 86% in 2015. The site continues to maintain it’s zero waste to landfill Corporate Certification. 2015 total primary energy usage reduced by 3.5% with a corresponding reduction in annual CO2 emissions of 8%. The site installed it’s first electric car (E-Car) charging point to encourage sustainable employee commuting. Trade effluent analysis continues to demonstrate excellent compliance with no analysis result greater than 50% of a licence limit. Similarly emissions to air continue to demonstrate excellent licence compliance with all monitored parameters less than 20% of the applicable limit. The site for the tenth consecutive year received no environmental complaints from it’s neighbours during the course of 2015. The site completed 28 continuous improvement tasks in 2015 as part of the sites current 5-year environmental improvement plan (2014-2018). 2015 was a good year from an external audit perspective with audits completed on site by Abbott Corporate and the British Standards Institute (BSi) (ISO14001). No significant environmental findings were identified from these audits. As part of our Moving to Zero Program the site will continue to work with its main stakeholders to build further upon the strong performance achieved in 2015. New Onsite E-Car Charging Station

Pat McLoughlin Site Director


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 2015 to 31-December, 2015. 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. 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 1,205 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

Pat Kealy

Manager, Operations

Muriel Bryan

Acting Director, Human

Resources

Pauline Hanley

Director, Quality

Madeleine Ryan

Manager, Quality Assurance

Priscilla Kerr


David McElroy

Manager, Engineering Pat Walsh

Manager, Operations

Kevin Finn

Manager, Engineering

Rodney Poche

Manager, IT Business

Relationship

Maureen Slattery

Manager, Supply Chain

Michael Crowe

DVP, WW Manufacturing

Operations

Aisling Cooney

Manager, Operations

Aiden Heney


Elaine Gleeson

Manager, Operations

Michael Tarrant

Manager, Business

Excellence

Conor Rainsford

Director, Operations

Diarmuid Meagher

Director, Innovation,

Technology & EHS

Ger Murphy

Manager, Facilities/EHS

James Hally

Financial Controller

James McCarthy

Controller, Global Operations

Kara Carter

Senior Director, QA Operations

Margaret Morrissey

Country Director, HR

Joan Casey

Senior Administrative Assistant

Tony Mannion

Director, IT Business

Relationships, Global

Manufacturing

Eilis Ryan

Supervisor /EHS

Kerry Williams

R&D

Margo O’Regan

Component Eng.


1.5 Organisational Structure --- Environmental

Waste Technicians (x2)

Energy Management (x1)

Effluent Systems (x1)

Security (x7)

Supervisor, Facilities

Manager, Facilities

EHS Coordinator

Emergency Response

Environmental Coordinator

Supervisor, EHS

Director, Innovation, Technology & EHS


2.0 Summary of Emissions 2015 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 2015 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 2015 is outlined in Table 2.1.1(a) below.

Table 2.1.1 (a), Summary of 2015 TOC & Pharmaceutical Dust Emissions to Atmosphere

Emission Type

Air Stack Ref.

Location Monitoring

Frequency

Analysis Method

2014 Mass Load (Kg’s)

2015 Mass Load (Kg’s)

Mass Load Limit (Kg’s)

Complieswith

Licence Limit

Total Organic Carbon

A2-1

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

Quarterly

I.S. EN 12619. (FID)

179.20 89.4 4785 Yes

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

767.71 887.09 3790 Yes

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

139.48 93.84 4785 Yes

A2-8 Suite No.1 – Drug Formulation.

21.09 102.92 3790 Yes

Pharma Dust

A2-1

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

Biannually ISO 9096

Total Particulate

<0.02 0.002 4.1 Yes

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

<0.02 0.0023 4.1 Yes

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

<0.02 0.002 4.1 Yes

A2-8 Suite No.1 – Drug Formulation.

<0.02 0.0021 4.1 Yes

*Based on the mass emissions limit (kg/hr) x 16 (hrs/day) x 255 (days/yr). 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 2015 Emissions to Air (Maximum result as % of Limit)

Table 2.1.1 (c), Summary of 2015 TOC & Pharmaceutical Dust Emissions Flowrates

Emission Type

Air Stack Ref.

2015 Average Hourly

Flowrate (m3)

2015 Maximum Hourly

Flowrate (m3)*

Hourly Flowrate Limit

(m3)

Complies with Licence Limit

Volumetric Flowrate

A2-1 5318 6878 11729 Yes

A2-2 5924 8302 9288 Yes

A2-7 5932 8134 11729 Yes

A2-8 4546 7220 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 2015. During 2016 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 2016.

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

0 25 50 75 100

23

Parameter

2

2.7

Annual Air Emissions

(as % of EPA limit)

1.9

0.05

0.05

0.05

0.05


2.2 Emissions to Sewer (Trade Effluent Discharges)

2.2.1 Emissions to Sewer Overview

A summary of trade effluent emissions to sewer for 2015 are shown in Table 2.2.1(a) below. Table 2.2.1(a), Summary of 2015 Emissions to Sewer

Ref Parameter

Sampling

Frequency

Analysis Method

Mass Emissions (Kg’s) 2014

Mass Emissions (Kg’s) 2015

Licensed Mass Emission Limit

(Kg’s)*

Complies with

Licence

SE-1

Volume Daily 17569 m3 14616 m3 73,000 m3 Yes

Temperature Continuous 11.78°C

(Max) 14.75°C (Max)

35°C Yes

pH Continuous Min: 6.88

Max: 9.03 Min: 6.88 Max: 9.44

5-10 Yes

BOD Quarterly G/04 APHA

2005, Method 5210B

1133.2 1069.5 29,200 Yes

COD Quarterly G/03 APHA

2005 Method 5220D

3730.3 2805.0 45,625 Yes

Suspended Solids

Quarterly G/19 APHA

2005, Method 2540B

4206.7 2234.7 29,200 Yes

Orthophosphate Quarterly G/67 APHA 2005, 4500-

PE 8.3 7.3 730 Yes

Oils, Fats & Grease

Quarterly G/032 APHA

Method 5520B

301.2 148.6 2,738 Yes

Sulphate Quarterly

G/67 Konelab

642.9 480.0 3,650 Yes

Total Heavy Metals

Annual

USEPA 200.8

7.6 5.0 N/A Yes

Acetone Annual G/14 Based

on ASTM Method D3695

0.46 0.5 N/A Yes

IPA Annual <L.O.D <L.O.D 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 2015. 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.


Table 2.2.1(b), Summary of 2015 Maximum Emissions Concentrations to Sewer (As a % of Limit)

Table 2.2.1(c), 2015 Toxicity Testing Results

Test Parameter Result Toxicity Limit

(Toxicity Units-TU)

Complies with Limit

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

Respirometry (180 min EC50 Sludge Sensitivity Test)

10 Normal Criteria:

2 - 25 Yes

Note: Test Date: 26-November 2015.

2.2.2 Interpretation of Emissions to Sewer Data (SE1) All 2015 laboratory analysis results for trade effluent emissions were below licence limits. Trade effluent flowrate compliance was at 99.7% with one daily volume/flowrate exceedance recorded on the 3rd January 2015. All laboratory monitored parameters continue to be significantly below relevant Emission Limit Values (ELV’s) with all parameters <33% of the licence limit. EPA monitoring at SE1 was conducted on the 23-April 2015 with all results <11% of the licence limit. Annual toxicity testing was completed for SE1 by Enterprise Environmental on the 26th November 2015 with results significantly below the sites licence limit. Respirometry testing was also completed on the 26-November 2015 and confirmed the continued suitability of the sites trade effluent for treatment at Clonmel Wastewater Treatment Plant. Testing showed the sites effluent to be within the normal range for sludge sensitivity. Annual heavy metals analysis identified metal levels in trade effluent at 34% of the limit, most of this is due to heavy metals in incoming towns water. The site expects the current high level of compliance with respect to this aspect to continue during 2016.

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%

2015

IPPCL %

Compliance0 25 50 75 100

Max Result

(as % of EPA limit) Parameter

7

5

13

9

20

8

8

1

18

15

29

33

1


2.3 Emissions to Surface Water

2.3.1 Emissions to Surface Water Overview

A summary of 2015 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) with weekly testing completed by Abbott. The range of results for each parameter is presented below. Table 2.3.1, Summary of 2015 Emissions to Surface Water 2015

Emission Point

Parameter Monitoring Frequency

2015 Range Average

SW1

Visual Inspection Weekly No evidence of contamination. n/a

pH min-max range Weekly 6.24 – 8.22 7.14

Conductivity (µS/cm) Monthly 310 – 1469 580

COD (mg/l) Monthly <10 – 84 39

2.3.2 Interpretation of Surface Water Data

Weekly pH testing and visual inspections have not identified signs of surface water contamination during 2015. Following modifications completed on the sites Cooling Towers in May 2015 the site has seen a significant reduction in Conductivity and COD levels compared to 2014. Table 2.3.2, Conductivity 2014 v 2015 Comparison

2014 2015 2015 (May-Dec)*

Conductivity (Average) 1216 580 444

Conductivity (Maximum) 8090 1469 692

* Process modifications completed in May 2015.

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 2015 Waste Collections

Table 2.4.1 (b), 2015 Non-Hazardous Waste Collections

Waste 2014 (Tonnes) 2015 (Tonnes) Change

2015 Total Waste Collections 682.125 599.17 12.16%

Total waste disposed 126.025 83.461 33.77%

Total waste recycled 556.1 515.709 7.26%

Total Waste Recycling % 81.5% 86.0% 4.5%

2015 Non-Hazardous Waste Collections 520.01 483.88 7%

Non-hazardous disposed 0 0 0

Non-hazardous recycled 520.01 483.88 6.95%

Non-Hazardous Waste Recycling % 100% 100% 0

2015 Hazardous Waste Collections 162.115 115.291 28.88%

Hazardous disposed 126.025 83.461 33.77%

Hazardous recycled 36.09 31.83 11.8%

Hazardous Waste Recycling % 22.26% 27.61% 5.35%

Waste Type EWC Code

2015 (Tonnes)

Toners 080318 0.24

Filter Cake (Non-Haz) 110110 2.62

Cardboard 150101 53.24

Plastic 150102 1.3

Mixed Recycle 150106 169.36

Glass 170202 3.4

Confidential Paper 200101 26.99

Compost 200108 32.67

Greasetrap Waste 200125 30.0

Canteen Oil 200125 2.2

Wood 200138 51.24

Metals 200140 26.12

MSW Waste (SRF) 200301 74.58

C&I 200307 9.92

2015 Non-Hazardous Waste Total: 483.88


Table 2.4.1(c), 2015 Hazardous Waste Collections

Waste Type EWC Code 2015 (Tonnes)

Sulphuric Acid 06 01 01* 1.097

Nitric Acid 06 01 05* 1.016

Other Acids 06 01 06* 29.264

Organic solvents and mother liquors 07 05 04* 12.4

Solid waste containing dangerous substances 07 05 13* 13.64

Waste Oil 13 02 05* 2.2

Petrol Interceptor 13 05 03* 5.0

Packaging containing dangerous substances 15 01 10* 15.628

Adsorbents and filters containing dangerous substances 15 02 02* 31.047

Waste Electrical Equipment 16 02 15* 3.069

Laboratory chemicals consisting of dangerous substances 16 05 06* 0.058

Discarded organic chemicals containing dangerous substances 16 05 08* 0.227

Biological Medical Waste 18 01 03* 0.315

Lamps 20 01 21* 0.330

2015 Hazardous Waste Total: 115.29

In accordance with Schedule C.4 Waste Monitoring, the analysis results for 2015 mixed solvent waste is shown below in Table 2.4.1 (d). Table 2.4.1(d) 2015 Mixed Solvent Waste Analysis

Parameter Average %

IPA 34.3

Acetone 26.6

Acetonitrile 6.7

Cyclohexanone 1.6

Heptane 3.0

Dichloromethane, Methanol, Chloroform ND

Water Content 31.7

ND - None detected.

2.4.2 Interpretation of 2015 Waste Data

The waste details outlined in Tables 2.4.1 (b) and 2.4.1 (c) above represents all waste collections from the Clonmel site during 2015. All off-site disposal and recovery routes used by the site are approved by the agency. The site recorded a reduction of 12.2% in total waste collections during the year versus 2014. Total waste generated in 2015 versus 2014 showed a reduction of 7.5%*. * (Some Q4 2015 wastes collected for disposal in January 2016.).

Waste Recycling 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 showed the sixth consecutive year on year increase from 81.5% in 2014 to 86% in 2015. The sites strong focus on recycling is demonstrated by Table 2.4.2 (a) shown below.


Table 2.4.2 (a), Total Site Waste Recycling Percentage (2009-2015)

During 2015 the Clonmel site again sent zero waste to landfill and was re-certified by Abbott Corporate as a ‘Zero Waste to Landfill’ facility. During 2015 the site completed Corporate approval of the Indaver ‘Waste To Energy’ facility in County Meath which now allows the site to generate a recycle code for some previously non-recycled waste streams.

Hazardous Waste Summary: The sites recorded a reduction in hazardous waste collections of 28.9% versus 2014 with some waste collections postponed until Q1 2016 in order to minimise waste collection visits. Hazardous waste generated in 2015 saw a reduction of 15.2% versus 2014 due to the following:

A 12% reduction in units manufactured in key waste producing operations units

More efficient usage of solvent for parts cleaning (less waste)

Increased usage of bottle washing facility to remove trace contamination and allow non-hazardous waste recycling.

Table 2.4.2 (b), Annual Hazardous Waste Collections (Metric Tonnes) (2008-2015)

The site continues to work closely with all it’s key waste stakeholders (e.g. employees, waste vendors, Corporate) with a view to making further waste improvements during 2016 in support of the sites 2018 environmental goals.


2.5 Resource Consumption

A summary of site energy and water consumption for 2015 is presented below.

Energy Consumption & CO2 Emissions

2.5.1(a) 2015 Primary Energy Consumption: Overall primary energy usage (Gas & Electricity) decreased by 3.5% [Table 2.5.1 (b)] following the completion of a number of energy reduction projects during 2015. Table 2.5.1(a), Primary Energy Consumption kWhr (Absolute)

Aspect 2013 Baseline 2014 2015

Primary Energy (Gas & Elec) 100% 101.9 (+1.9%) 98% (- 2%)

Table 2.5.1(b), Primary Energy Consumption kWhr (Absolute)

Aspect 2014 2015

Primary Energy (Gas & Elec) 63,813,449 61,642,408 (-3.5%)

Diesel (Litres) 200 190 (-5%)

2.5.2 2015 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 2015. Table 2.5.2(a), 2015 Electricity Consumption (Absolute)

Site Electricity Usage 2014 – 2015 (kWhr)

Energy Stream Annual Quantity 2014 Annual Quantity 2015

Electricity Imported 14285523 13845861

Electricity Generated Onsite (CHP) 9823000 9393950

Total Electricity Consumed Onsite 24108523 23239811 (-3.6%)

2.5.3 2015 Gas Consumption Gas consumption for the site reduced by 3.8% as a result of less CHP demand and reduced demand for onsite space heating. Table 2.5.3 (a), 2015 Gas Consumption (Absolute)

Energy Stream Annual Quantity 2014 Annual Quantity 2015

Natural Gas for CHP 22,805,663 22,550,182

Natural Gas Total 28,099,619 27,027,755 (-3.8%)


2.5.4 2015 CO2 Emissions Site CO2 emissions reduced by 8.0% as a result of a 3.5% reduction in primary energy and a greener fuel mix from Airtricity during 2015. Table 2.5.4 (a), CO2 Emissions 2015

Aspect 2014 2015

CO2 (Kg) 11,024,399 10,141,793 (-8%)

2.5.5 2015 Water Consumption Water usage increased by 13.6% during 2015 due to increased water demand from site utilities. Water management will be a key area of site focus during 2016 as the site endeavours to meet it’s 2018 water reduction target of 15% versus 2013 usage. Table 2.5.5 (a), Water Consumption 2015 (Absolute)

Aspect 2010 2011 2012 2013 2014 2015

Water (m3) 50,078 48,726 43,237 44,029 46,982 53,373 (+13.6%)

2.6 2015 Environmental Incidents & Complaints

2.6.1 EPA Reportable Incidents There was one licence exceedance reported to the agency during 2015. Table 2.6.1(a), EPA Reportable Incidents

Incident Type Date Status

Trade effluent flowrate and daily flow exceedance (SE-1)

3-Jan-2015 Remedial action completed.

2.6.2 General Public Complaints

No environmental complaints were received from the general public during 2015. The site has not received an environmental complaint of any type in the last 10 years.

Table 2.6.2 (a), General Public Complaints

Year 2006 - 2014 2015

Complaints 0 0

2.7 EPA Monitoring and Enforcement

2.7.1 EPA Site Inspections The site received no inspector inspections during the course of 2015.

2.7.2 EPA Environmental Emissions Monitoring The following table summarises on-site emissions monitoring undertaken by the Agency during 2015.

Table 2.7.2(a), Agency Emissions Monitoring 2015

Monitoring Type Monitoring Date Non-Compliances

EPA Trade Effluent Sampling 23-April 2015 None


3.0 Management of the Activity

3.1 Environmental Management Programme (EMP)

3.1.1 2015 EMP Report The site targeted completion of 28 individual tasks under it’s 2015 Environmental Management Program, all 28 were completed during the year. Full 2015 program details are provided in Appendix B.

3.1.2 2016 EMP Proposal Abbott’s 2016 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 2015 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 2015 are detailed in Table 3.2.1 below. Table 3.2.1(a), 2015 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 2016 PRTR Proposal

The substances to be tracked and reported for 2016 will remain the same as 2015.


4.0 Licence Specific Reports

4.1 Environmental Noise Monitoring Report

4.1.1 Noise Monitoring Data Overview

An environmental noise assessment was conducted on the 07th September 2015 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) 2015 Environmental Noise Monitoring – Noise Sensitive Locations (NSL’s)

Location

Day/ Night

LAeq dB(A)

LA90 dB(A)

Tonal Noise

LAr,T

Comments

NSL1 Day 66.8 54.4 No 66.8 The LAr is higher than the limits mentioned in the

license. The exceedance is caused by road traffic on

the R688. Traffic movement is constant on the

R688 and vehicles pass at a rate of between 12 and

24 vehicles per minute during day time. At night

time less, but still clear audible. Abbott Vascular

has only stationary noise sources which are

positioned at the rear of the buildings and therefore

screened from NSL 1 and NSL 2. The LA90 value

during night periods is 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. If

we base the LAr on LA90 no exceedance is

observed.

There is no audible or tonal noise coming from the

Abbott Vascular site at NSL 1 and NSL 2.

NSL1 Day 64.6 45 No 64.6

NSL1 Day 66.1 48.4 No 66.1

NSL1 Night 50.8 32 No 50.8

NSL1 Night 52.8 36 No 52.8

NSL2 Day 69.7 48.5 No 69.7

NSL2 Day 68.4 38 No 68.4

NSL2 Day 68.5 43.5 No 68.5

NSL2 Night 46.2 28.5 No 46.2

NSL2 Night 52.7 33 No 52.7

Table 4.1.1(b), 2015 Environmental Noise Monitoring - Site Boundary Monitoring

Location Day/ Night

LAeq dB(A)

LA90 dB(A)

Tonal noise

LAr,T

Comments

N1 Day 52.1 47.4 No 52.1 No boundary locations are adjacent to NSL 1 or NSL2.

At N1 the LAr values based on LAeq are relative high.

This is caused by road traffic on the R688. Furthermore,

during night time an alarm from a neighbour company

affected the results negative with approximately 3

dB(A).

At N2, two readings were initially above the night limit

due to noise issues from the CHP unit. After corrective

maintenance work was completed re-monitoring was

completed on the 22-23 September and levels were

found to below the limit.

At N4 the LAr values based on LAeq are relative high.

This is caused by road traffic on the R688. It is

supported by the fact that the LA90 values were relative

low.

N1 Day 49 41.4 No 49

N1 Day 49.5 44.4 No 49.5

N1 Night 41.3 37.8 No 41.3

N1 Night 43.6 40 No 43.6

N2 Day 50.2 48.4 No 50.2

N2 Day 47 45 No 47

N2 Day 47.2 45.2 No 47.2

N2 Night 45.1 44.4 No 54.1

N2 Night 44.4 43.8 No 44.4

N4 Day 54.9 48.5 No 54.9

N4 Day 52.7 41 No 52.7

N4 Day 54 45.5 No 54

N4 Night 44 37 No 44

N4 Night 43.9 38.5

No 43.9


4.1.1(c) 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 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 noise limit. LA90 readings were also taken and indicate that the predominant noise contribution is from road traffic on the R688. No audible or tonal noise was identified at noise sensitive monitoring locations. b) Boundary Noise Levels No audible or tonal noise was identified at the site boundary. Noise at N1 and N4 is mainly influenced by road traffic from the R688, Clonmel to Cashel Road. High noise levels at N2 were attributable to noise issues with the adjacent Combined Heat & Power Unit (CHP). This issue was addressed via planned maintenance and the noise returned to a level below the night limit. The agency has informed the site that ongoing monitoring at N3 is now no longer required.

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 2015. 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 2015 Solvent Management Plan

4.2.1. Introduction

A Solvent Management Plan (SMP) is required to be submitted for each calendar year. A SMP for 2015 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, N-Hexane Dichloromethane (DCM) Methanol Acetonitrile Chloroform

On Site Solvent Storage Facilities

4.2.2. 2015 Site Solvent Mass Balance A mass balance on solvent input and output has been performed on each of these solvents for 2015 and is outlined on page 21, Table 4.2.2(b). The site over the last six years has implemented a range of projects to minimise solvent use at a time of significant production growth. The site has reached a point where its absolute usage has been declining since 2012, see Table 4.2.2(a) below. 4.2.2(a) Coating & Total Site Solvent Usage (Kg)


4.2.3. Discussion on 2015 SMP Result - Assessment of compliance with VOC Fugitive Emission Limit

The mass balance shown below in Table 4.2.2(b) demonstrates that the unaccounted for figure treated as fugitive emission is 18.7% of the solvent input, which is below the VOC fugitive emissions limit of 20% of the solvent input set by the sites IPPC licence. Hence, the site is compliant with the VOC fugitive emission limit.

4.2.4. 2015 Fugitive Emissions Reduction Update

The following activities were completed during the course of 2015 and/or are planned for 2016: 1. More efficient use of solvent for cleaning of DES parts during 2015. 2. Initial solvent usage assessments have been completed in the new Vessel Closure area.

These assessments shall be finalised in 2016 as Vessel Closure ramps to normal manufacturing levels.

3. The site will complete baseline solvent stack monitoring in Vessel Closure during 2016 as the process reaches normal manufacturing levels.

4.2.5. Solvent Recovery, Reuse & Substitution Given the nature of the sites manufacturing processes there are limited options open to the site with regards to on-site solvent recovery and reuse. The site has reviewed the feasibility of substituting solvents with less harmful ones but this was found to be impracticable.


Table 4.2.2 (b) 2015 Site Solvent Mass Balance

Component Methanol IPA Acetone DCM Chloroform Cyclohexanone n-

Hexane Heptane Acetonitrile

TOTAL (Kg)

I1 – 2015 Inputs 95.6 10485.1 106.48 30.4 0 466.5 0 464.4 651.7 22842

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

I - TOTAL INPUT 95.6 10485.1 106.48 30.4 0 466.5 0 464.4 651.7 22842

O1 Solvent emissions in Waste Gases 0 85 1843 0 0 39.9 0 0 0

O2 Solvents lost in Water (SE1) 0 0 0.5 0 0 0 0 0 0 0.5

O3 Solvents residue on Product (N/A) 0 0 0 0 0 0 0 0 0 0 O5 Solvent Treated or Reacted (Primer Spray Carbon Filters) 0 0 113 0 0 49 0 0 0 161

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

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 7734 5861 0 0 319 0 591 1742 16247

O9 Solvent released in other ways (N/A) 0 129 0 0 0 0 0 0 0 129

O- 2015 TOTAL OUTPUT 0 8003 7704.5 0 0 407.4 0 591 1742 18565

O4 Fugitive Emissions: 95.6 2482.1 2944.2 30.4 0 59.1 0 -126.6 -1090 4276.5

Total Fugitive Solvent Losses (Air and Water): 18.7%


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 2015 was calculated from data obtained from the Supply Chain Solvent Usage Tracker and from separate Xiam orders placed by Laboratories. I2 – Internal Recycle – no recovered solvent is reused onsite, virgin solvent is required for all operations. Solvent Outputs (O): O1 - Solvent Emissions in Waste Gases. Figures calculated from quarterly monitoring data of main emissions points which were operational during 2015: A2-1, A2-2, 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 2015. 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) – Solvent used as part of the Primer Spray process is captured in an activated carbon filter. O6 - Collected Waste Solvent – Waste containing solvent sent off site for disposal (as opposed to recovery) includes wipes used for cleaning with acetone and IPA. The content of IPA and acetone on these wipes has been estimated using results of weighing wipes before and after use. 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’. Drums of solvent waste for recovery offsite were analysed for solvent content, this data was used as a basis to estimate the breakdown of all waste solvent sent off site for recycling during 2015. 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 2015.


4.3 Energy Efficiency Auditing Introduction The last comprehensive site energy audit was completed by Project Management (PM) in March 2015.

Site Energy Management System Overview Site headcount recorded at the end of 2015 was 1,205 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 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 2015 and planned for 2016 are detailed within the EMP updates provided in Appendices B & C of this document.

4.4 Decommissioning Management Plan (DMP) Review

The DMP was last revised in 2014 with the update submitted to the agency on the 18-November 2014. A further revision to this document is to be completed and submitted to the agency before the 31-March 2016.

4.5 Environmental Liabilities Risk Assessment (ELRA) Review The sites ELRA document was also revised during 2014 and the report submitted to the agency on the 18-November 2014. A further revision to this document is also to be completed and submitted to the agency before the 31-March 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 have issued a third party bond to the EPA. Abbott are awaiting approval from the Agency prior to the bond being issued by Abbott’s insurer.

4.7 Testing of Underground Tanks, Sewer Pipes and Bunds

The testing and inspection of all underground pipes, tanks and bunds was completed during 2014 for all trade and domestic sewage pipelines. Testing included both camera surveying and hydrostatic pressure testing. The 2014 pipeline inspection regime identified a program of preventative maintenance works with timelines for completion extending to the end of 2016. Abbott is on track to complete this program in the first half of 2016.

4.8 Waste Prevention, Minimisation and Recycling Summary During 2015 the site continued to reduce hazardous waste generation on site and continued to increase total waste recycling rates. Total hazardous waste quantities generated during 2015 showed a drop of 15.2% versus 2015. Total waste recycling increased from 81.5% to 86%. Waste reduction will continue to be a key focus for the site during 2016 in support of the sites 2018 waste reduction goals.

4.9 Raw Material Usage and Efficiency During 2015 the sites total solvent usage decreased by 17%. The main solvent usage changes during 2015 are detailed below:

Reduced acetone usage for DES parts cleaning (more efficient use)

Reduced isopropanol usage in SDS due to a change of product mix (less ultrasonic cleaning).

The planned use of Chloroform for laboratory testing has been postponed.

4.10 Minimisation of Water Demand and Trade Effluent Water usage increased in 2015 by 13.6% due to increased water demand from site utilities. Water management will be a key area of site focus during 2016 as the site endeavours to meet it’s 2018 water reduction target of 15% baselined to our 2013 usage. The site has already improved it’s water metering during 2015 and will improve tracking and analysis of water usage by linking the meter outputs into it’s EFT energy tracking system. The site is also committed to the installation of a new greywater recycling system within the next 2 years.


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

Primary Energy Reduce primary energy by 5% versus 2013 baseline.

Total Waste Reduction Reduce total waste by 15% versus 2013 baseline.

Total Waste Recycle % Increase total waste recycle figure to > 85%.

Water Conservation Reduce water usage by 15% versus 2013 baseline.

4.12 Submitted Reports 2015 The following reports were submitted in full to the EPA during the year:

2014 Annual Environmental Report (AER) & PRTR

Acid Scrubber Switch-Off Proposal

Proposal for Extended Period of Surface Water Conductivity Testing

Results of Extended Surface Water Conductivity Testing

31-March 2016 Annual Environmental Report 2015

APPENDIX A – AER Returns Worksheet


5.1 Releases To Air 2015

SECTION B : REMAINING PRTR POLLUTANTS

QUANTITY

Main

Emission

Points (A2-1,

A2-2, A2-7,

A2-8)

Boilers (A3-

3, A3-4, A3-

5) and CHP

(A3-19)

Minor

Emission

Point -

Scrubber

(A3-13)

Minor

Emission

Point

A3-11

Hazmats

No.

Annex II 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

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. 1937.9 0.0 0.0 85.1 6304.5 0.0 4281.5

80

Chlorine and inorganic

compounds (as HCl) M CRM

FTIR Analysis using

ASTM D6348-03 117.0 0.0 0.0 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

02 Carbon monoxide (CO) M EN 15058:2004

Using Bord Gais

Conversion Factor:

205.6gCO2/kWhr 0.0 24647.0 0.0 0.0 24647.0 0.0 0.0

03 Carbon dioxide (CO2) C OTH 0.0 5527176.0 0.0 0.0 5527176.0 0.0 0.0

08 Nitrogen oxides (NOx/NO2) M EN 14792:2005 0.0 14907.0 0.0 0.0 14907.0 0.0 0.0

11 Sulphur oxides (SOx/SO2) M EN 14791:2005 0.0 7145.0 0.0 0.0 7145.0 0.0 0.0

04 Hydro-fluorocarbons (HFCs) E OTH 0.0 0.0 0.0 0.0 100.0 0.0 100.0

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 0.002 0.0023 0.002 0.0021 0.0084 0.0 0.0

SECTION C : REMAINING POLLUTANT EMISSIONS

Method Used

RELEASES TO AIR

POLLUTANT METHOD

Method Used

RELEASES TO AIR

POLLUTANT METHOD


5.2 Releases To Water 2015

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

A (Accidental)

KG/Year

F (Fugitive)

KG/Year

306 COD M ALT

G/03 Based on APHA 2005, 21ST

Edition, 5220D, Closed Reflux,

colorimetric method. 2704.0 2704.0 0.0 0.0

POLLUTANT

RELEASES TO WATERS

POLLUTANT

Method Used

RELEASES TO WATERS

Method Used

RELEASES TO WATERS

POLLUTANT

Method Used

T (Total)

KG/Year

A (Accidental)

KG/Year

F (Fugitive)

KG/Year

Emission

Point 1

T (Total)

KG/Year

A (Accidental)

KG/Year

F (Fugitive)

KG/Year

Emission

Point 1


5.3 Releases To Sewer 2015

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 0.04 0.04 0.0 0.0

20 Copper and compounds (as Cu) M CRM Heavy Metals: G/57 ICP-Ms based on EP Method 200.8 0.45 0.45 0.0 0.0

24 Zinc and compounds (as Zn) M CRM Heavy Metals: G/57 ICP-Ms based on EP Method 200.8 0.76 0.76 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 1069.5 1069.5 0.0 0.0

306 COD M CRM G/03 APHA 2005 Method 5220D 2805.0 2805.0 0.0 0.0

314 Fats, Oils and Greases M CRM G/032 APHA Method 5520B 148.6 148.6 0.0 0.0

330 Organic solvents M CRM G/14 Based on ASTM Method D3695 0.5 0.5 0.0 0.0

332 Ortho-phosphate (as PO4) M CRM G/67 APHA 2005, 4500-PE 7.3 7.3 0.0 0.0

343 Sulphate M CRM G/67 Konelab 480.0 480.0 0.0 0.0

347 Total heavy metals M CRM USEPA 200.8 5.0 5.0 0.0 0.0

240 Suspended Solids M CRM G/19 APHA 2005, Method 2540B 2234.7 2234.7 0.0 0.0

POLLUTANT METHOD

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

POLLUTANT METHOD

Method Used

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

Method Used

T (Total)

KG/Year

T (Total)

KG/Year

A

(Accidental)

KG/Year

F

(Fugitive)

KG/Year

A

(Accidental)

KG/Year

F

(Fugitive)

KG/Year


5.4 Site Transfers of Waste 2015




APPENDIX B – 2015 EMP Update


2015 Environmental Management Program Report

Objective Targets & Objectives Status

Update

1. Energy Installation of new EFT Energy Monitoring System. Complete

Roll Out of New Site Energy Team. Complete

Lighting: Motion sensor controls for DES offices, DES suites circulation corridor. Complete

Lighting: Motion sensor control review of the DES Suites 4 & 3. Complete

Lighting: complete feasibility study into change to LED light fittings. Complete

Energy Awareness: complete energy awareness communications plan for

management review. Complete

ECar Charging Point: Secure financing for installation in Q1 2016. Complete

Equipment Switch Off – Complete investigation into potential for switching off

production equipment at night and/or over the weekend. Complete

Investigate replacement of primary Chilled water pumps with Grunfoss unit. Complete

Investigate installation of high efficiency water softener. Complete

Investigate Chilled water and LTHW secondary system flow adjustments. Complete

Investigate Chilled water flows and pump speeds to be adjusted to reduce power and equalise flows to each chiller. Complete

Investigate Chiller Sensor calibrations. Complete

Investigate Potable water pump replacement with Grunfoss control unit. Complete


2. Waste

Complete site waste review to identify opportunities for reduction and/or recycle. Complete

Complete review and approval of CJ Sheeran for the resale of wooden pallets. Complete

Investigate use of reusable bulk container for collection/transport of DES waste. Complete

Complete approvals for use of Indaver’s new Meath ‘Waste To Energy’ Facility. Complete

Obtain Abbott Corporate Zero Waste To Landfill Re-certification. Complete


3. Resource Usage

Complete Annual Solvent Mass Balance based on 2014 Solvent Data. Complete

Complete Vessel Closure Solvent Usage Review. Complete

Complete Vessel Closure Baseline Solvent Stack Analysis. Complete


4. Water Complete study to identify water savings at the sites cooling towers. Complete

Complete Water Harvesting (Grey water) Feasibility Study. (Non-Financial) Complete

Complete Surface Water Conductivity Site Survey. Complete

Submit Heavy Metals in Trade Effluent Report to the EPA. Complete

Investigate Feasibility of adding a special Environmental Permit To Work to the

existing electronic contractor permitting system. Complete

Complete Annual Trade Effluent Toxicity Testing. Complete


APPENDIX C – 2016 EMP Proposal


Abbott Clonmel 2016 Environmental Management Programme

2016 Environmental Management Programme Overview:

In accordance with Condition 2.2.2.3 the sites 2016 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: 14001:2004. 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

The objectives within the sites 2016 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 2015 EMP.

Identification of any IPPC related actions to be completed during 2016.

A review of internal environmental audits and compliance reviews.

Any other site and/or Abbott Corporate specific 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 2016 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).

2016 Environmental Management Programme

SHE2062444

Rev G

Page 37 of 39


Objective 1 Aspect

Actions

Energy

Aspect 5: Complete Gap Analysis of ISO50001 Standard and present proposal to Facilities Management/EHS.

Complete HVAC review to identify energy saving opportunities.

Complete installation of LED lighting in site canteen.

Upgrade of EFTE Tracking System to include water metering.

Complete site review to identify water reduction opportunities.

Complete Annual Solvent Mass Balance.

Objective 2 Aspect Actions

Waste Aspect 1 & 3:

Complete Annual Waste Stream Analysis.

Explore feasibility of sending Implants Waste To Meath Energy Recovery Facility.

Complete full review of waste segregation practices in DES.

Objective 3 Aspect

Actions

Supply Chain Aspect: 5 Agree process with Supply Chain for off-site reuse of good quality wooden pallets.

Review opportunities for supplier take-back of cardboard.

Objective 4 Aspect

Actions

Water Aspect 5 + 10

Water Usage

Complete follow-up review of Surface Water Conductivity results following 2015 improvements.

Complete Review of Water Tank Chlorination Operation.

Objective 5 Aspect

Actions

Air Aspect: 6 Complete Baseline VOC Stack Emission monitoring in Vessel Closure Suite (at full production).

Determine Site Solvent Fugitive Emissions.

Confirm Vessel Closure Solvent Usage and Solvent Fugitive Emissions (at full production).

Objective 6 Aspect

Actions

Regulatory Compliance N/A Submit 2015 Annual Environmental Report and Pollutant Release & Transfer Register (PRTR) to EPA.

Complete full review of Corporate Environmental Technical Standards.

Submit Environmental Liability Risk Assessment (ELRA) and Decommissioning Management Plan (DMP) revisions to the EPA.

Objective 7 Aspect

Actions

Other Requirements N/A Complete full ISO14001 2015 Gap Analysis and return transition questionnaire to BSi.

Complete ISO14001 2015 transition training for key subject matter experts (SME's).

Complete ISO14001 2015 documentation system revisions.

Complete ISO14001 2015 Readiness Review with BSi. All actions for closure between 1-Jan 2016 and 31-Dec 2016.

Documents

EXECUTIVE - Environmental Protection Agency · EXECUTIVE SUMMARY ... 4.2 2015 Solvent Management Plan ... 179.20 89.4 4785 Yes A2-2 Suite No.2 – Mandrel solvent cleaning