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Vistakon Ireland Ltd AER 2010Rev1 IPPC Licence Compliance

AAnnnnuuaall EEnnvviirroonnmmeennttaall RReeppoorrtt 22001100

Integrated Pollution Prevention & Control Licence Reg. No. P0818 - 02


CCoonntteennttss 1. Introduction

1.1 General

1.2 Environment, Health & Safety and Quality Policy Statements

1.3 Organisation Chart for Environmental Management

1.4 Water Emissions Monitoring Data

1.5 Air Emissions Monitoring Data

1.6 IPPC Licence Compliance

1.7 Noise Survey

1.8 Waste Arising

1.9 Resource Consumption

1.10 Environmental Incidents and Complaints

2. Management of the Activity

2.1 Introduction

2.2 Status Report on Schedule of Objectives and Targets

2.3 Environmental Management Plan

3. Pollution Release and Transfer Register (PRTR)

4. Bund Integrity Assessment Report

5. Tank and Pipeline Testing and Inspection

6. Environmental Liabilities and Residual Management

7. Licence Specific Reports:

Attachment 1 – Environment, Health & Safety Policy

Attachment 2 - ISO14001 Certification

Attachment 4 – Summary of Energy Management

Attachment 5 – Fire Water Risk Assessment

Attachment 6 - Summary of Emissions and Waste PRTR

Attachment 7 – Decommissioning Management Plan & ELRA

Attachment 8 – Ground Water Monitoring Plan

Attachment 9 – Solvent Management Plan


1. INTRODUCTION

1.1 General

Vistakon Ireland Ltd develops, manufactures and distributes a range of soft, disposable contact

lenses. The facility is located in the National Technology Park, Castletroy, Co. Limerick. The site

was granted an Integrated Pollution Prevention and Control (IPPC) Licence in August 2007 (No.

P0818-01) and a revised IPPC Licence (No. P0818-02) in July 2011.

Vistakon Ireland obtained planning permission for the construction of the first phase of the

existing buildings, the contact lens manufacturing process and ancillary facilities in 1994. The

second production block and ancillary services were installed in 1997-1998, along with ancillary

support areas. Until 2007, the production of the disposable contact lenses included a water-

based washing step. During 2007 and 2008, 20% of production lines were converted to include a

solvent based washing step using Iso-Propyl Alcohol (IPA)/water mixture. The production of

these new products required the use of IPA in quantities that exceed thresholds set for a Class

12.2.1 Activity in the EPA Act 1992-2004 and hence the site required an Integrated Pollution

Prevention and Control (IPPC) Licence. The site was granted an IPPC Licence in August 2007 (No.

P0818-01). A revised Licence (P0818-02) was issue in July 2010 to include for a new CCP

(Combined Cooling and Power) facility and a geothermal cooling project. CCP is a CHP

(Combined Heat and Power) based system designed to supply electrical energy and cooling

using natural gas. It was installed as part of the site’s on-going energy efficiency and CO2

reduction programs.

The main production operations and supporting functions are conducted primarily inside the

main production building. This building houses the following areas:

Manufacturing Area

Administration and Laboratory

Canteen

Offices

Warehouse

Outside of the main building, on the site, are located:

Service Compound

Utilities


Sprinkler pumps (diesel driven)

Warehouse chemical store

Water room

Electrical sub-station and transformers

Process/manufacturing area bunds

Tanker offloading/loading area with full tanker containment

Tank Farm

Thermal Oxidiser

Fire water retention pond

CCP Compound

Parking for the site is located to the south of the site, in front of the administration area.

Since operations began in 1996, there has been a very strong focus on continuously improving environmental performance. In 1999, the Limerick site became the first contact lens manufacturing plant in the world to receive the ISO 14001 environmental management standard. The Irish site has been a global leader in developing innovative processes and technologies resulting in significant environmental performance improvements and efficiencies.Vistakon has achieved very ambitious annual targets on carbon reduction and energy efficiency. Electricity Usage per lens produced has been reduced by 30% during the period 2007-2010. Significant also is the fact that 50% of that electricity used is sourced from renewable sources. This had been achieved with a sustainability focused strategic vision, proactive employee participation

The Annual Environmental Report (AER) has been prepared for the period 1st January 2010 – 31st

December 2010 in accordance with Condition No. 11.9 of Vistakon’s licence. Reference has been

made to the EPA Guidance Note for Annual Environmental Report in preparing the report.

1.2 Environment, Health & Safety Policy Statement

The site’s Environment, Health & Safety Policy is included in Attachment 1.

1.3 Organisation Chart for Environmental Management

The organizational chart for the Vistakon Facility contained in the Vistakon Ireland

Environmental Systems Manual can be seen in Figure 1.1 below.


Organisational Chart 2010

EHS SPECIALIST EHS SPECIALIST

EHS MANAGER

FACILITIES TEAMLEADER

SITE SECURITY

FACILITIES TECHNICIANS CAL/WR TECHNICIANS

FACILITIES ENGINEERS

LOGISTICS PERSONNEL

PUR/WH/SP

LOGISTICS DIRECTOR

HR SPECIALISTS

HR DIRECTOR

QUALITY TECHNICIANS

QC/MICRO/CHEM

QUALITY TEAM LEADERS

QUALITY DIRECTOR

FINANCE TEAM

FINANCE DIRECTOR

TOOL ROOM TECHNICIANS

MET

ENGINEERING TEAM LEADERS

ENGINEERING DIRECTOR

PROCESS TECHNICIANS

OPERATIONS ENGINEERS

BUSINESS UNIT MANAGERS

OPERATIONS DIRECTOR

FACILITIES DIRECTOR

General Manager

VP WW OPERATIONS

VP WW SUPPLY CHAIN


1.4 Water Emissions Monitoring

1.4.1 Emissions to Surface Water (SW1)

There is one emission point to the Mulkear River from the Vistakon site. SW-1 consists of

uncontaminated surface water runoff. A sampling chamber allows for monitoring of the surface

water. Storm water checks at SW-1 are recorded on the daily inspection check sheets. No

unusual results were evident in the storm water drain monitoring points during 2010.

1.4.2 Emissions to Sewer (SE1)

There is one licensed emission (SE-1) to sewer at the Vistakon site. All trade effluent

wastewaters from Vistakon are discharged to the National Technology Park’s fouls sewerage

system that discharges to the Castletroy Wastewater Treatment Plant (WWTP) operated by

Limerick County Council. Results of sampling between January and December 2010 can be seen

in Table 1.1 below.

As can be seen from Table 1.1 the mass emissions of all parameters are below the emission limit values. Spot samples were also taken during 2010 by the EPA and no significant issues were identified.

1.4.3 Groundwater Monitoring

There were three environmental assessments completed on the quality of groundwater within the site area. These were carried out in February, September and December. The resultant data is presented in Attachment No. 8. No significant issues were identified during 2010.


Table 1.1: SE1 Emission to Castletroy Wastewater Treatment Plant (January – December 2010)

1.5 Air Emissions Monitoring

There is one licensed emission point (with limits) to the atmosphere from the Regenerative Thermal Oxidiser (A2-1). A2-1 is continuously monitored for TOC and bi-annual samples are taken for Nitrogen Oxides and Carbon Oxide. The results for 2010 are presented in Table 1.2.

Table 1.2: Thermal Oxidiser Emissions January 2010 – December 2010 Parameter Mass

Emissions

(Kg) 2008

Mass

Emissions (Kg) 2009

Mass

Emissions

(Kg) 2010

Licensed

Mass

Emissions

(kg)

Organic

carbon (TOC

as C)

463 380 494 5,265

Nitrogen

Oxides (NOx)

39 684 1,173 14,016

Carbon

Monoxide

(CO)

5 108 141 7,008

Volumetric

Flow (Nm3/h)

4,213 3,523 5,357 9,000

Parameter Mass Emission

2008 (Kg)

Mass Emission

2009 (Kg)

Mass Emission

2010 (Kg)

Licensed Mass

Emissions (Kg)

Volume Daily Max

(m3) 227,760 301,628 261,223 529,250

BOD 65,638 184,513 189,480 370,475

COD 218,280 321,592 428,144 584,000

Total Phosphorus 136 233 93 1058.5

Suspended Solids 2,774 4,709 6,813 52,925

Total Dissolved

Solids 609,463 919,184 873,333 2,646,250

Fats, Oils, Grease 2,577 1,415 2,068 18,523

Detergent (as

MBAS) 6.9 10.9 73 10,585


A survey of the boilers and CCP emissions was conducted during 2010 data is presented in Attachment No. 3.

1.6 IPPC Licence Compliance

The site is generally compliant with its IPPC Licence conditions. There were reported weekly BOD & COD exceedences between January & July pending the new discharge limits in the revised IPPCL issued July 2011. Agreement had been received from Limerick County Council on the increased flow to their sewer system for treatment in 2010. The site was the subject of an EPA Inspection in November 2010 and a number of visits from Agency staff to take samples of groundwater, process effluent and air samples. No non-compliances were raised as a result of any of these visits. The site also operates an environmental management system (ISO 14001 re-certified October 2011 Attachment No. 8) resulting in regular internal and external environmental audits. A summary of the incidents is provided in Section 1.10 below.

1.7 Noise Survey

An environmental survey was undertaken to determine compliance with Condition 4.5 of the site’s IPPC Licence (Register No. P0818-02). Noise Levels were measured at the 4 No. boundary locations and at 2 No. nearest noise sensitive locations (NSLs). These are detailed in Table 1.3

Table 1.3: Noise Measurement Locations

Location No. Description

AN1 North Boundary: in front of the cooling towers

AN2 North eastern Boundary: adjacent to the pump house

AN3 Eastern Boundary

AN4 Southern Boundary: at the site entrance car park

AN5 (NSL1) North east of the facility at the entrance gate of a farm approximately

100m west of the Mulkear River.

AN6 (NSL2) Located to the south east of the facility, at the end of residential cul de

sac. This location is on the lands of Bohemians Rugby grounds.

1.7.1 Results

Condition 4.5 states: “Noise from the installation shall not give rise to sound pressure levels (Leq, T) measured at the boundary/NSLs of the installation which exceed the limit value(s).”

Table B.4: Noise Emissions Limits IPPC Licence Boundary Location

Reference Day-time dB (A) LAeq (30 minutes)

Night-time dB (A) LAeq (30 minutes)

AN1 163743E 158106N 61 61

AN2 163881E 157950N 55 49

AN3 163737E 157843N 55 45

AN4 163609E 157879N 55 45

Noise sensitive locations

-- 55Note 1

45Note 1


Note 1: There shall be no clearly audible tonal component or impulsive component in the noise emission from the activity at the noise sensitive location.

Table 1.4: Noise Monitoring Results Location No. LAeq,

Daytime2009 LAeq, Night-time

2009 LAeq,

Daytime2010 LAeq, Night-time 2010

AN1 59.3 57.6 59.9 60.5

AN2 51.7 57.6 50.8 47.8

AN3 57 51.2 52.7 48.0

AN4 54.6 48.5 54.4 45.3

AN5 (NSL1) 58.5 49.5 52.6 50.7

AN6 (NSL2) 44.5 44.5 49.0 44.0

The daytime and night time noise levels recorded at AN1, AN2, AN3, AN4, AN5 and AN6 are similar and in some cases better than those recorded during the 2009 survey. Additional noise bunding was installed on fans in the IPA yard closest to AN2 and AN3 during 2010. The facility is located close to busy roads including the N7 and background traffic noise levels are a significant contributor to noise levels. In addition:

No Vistakon facility-related impulsive or tonal noises were recorded during the monitoring periods.

Both monitoring location closest to the primary noise source of the facility are in full compliance.

The facility is in full compliance at all the monitoring points not directly affected by traffic.

No tonal noise was recorded at night at any of the six monitoring locations at night.

Locations AN3, AN4 and AN5 are significantly impacted by local traffic noise and it may be worthwhile considering alternative locations more appropriate to monitoring any noise emissions from the Vistakon facility.


1.8 Waste Arising – Final Updated by AI 29/03/2011- Completed

Annual waste arising for 2010 is summarized in Tables 1.5 and Table 1.6 below. Records for hazardous waste shipments sent off-site including waste contractor documentation, TFS (Transfrontier Shipment) forms and C1 Consignment forms are held on site and are available for viewing.

Table 1.5: Annual Hazardous Waste Arising 2010 Waste Description

EWC Code Quantity Tonnes/Year

Transporter Further Treatment (Method, Location & Undertaker)

Recovery, reuse or recycling (Method, Location & Undertaker)

Final Disposal (Method, Location & Undertaker)

Medical/Sharps – Bio Waste

18 01 01* 0.31

Collected by: SRCL Collection Permit WCP/LK/11707C WCP-DC-09-1178-01

N/A

N/A Disposal by: SRCL Dublin W0055-002

UV & Florescent Tubes

20 01 21* 2.84

Collected by: Irish Lamp Recycling Co. Kildare Licence No. WFP/KE/08/0348/01 Collection Permit No. WCP/DC/08/1115/01

N/A Recycling by Irish Lamp Recycling

Disposed by: Irish Lamp in Kildare

Chemicals Note: Mainly Solvent contaminated wipes

15 02 02* 07 05 04 20 01 27

18.93 Collected by: Veolia previously AVR Limited/ Waste Permit No: W0050-2 Transport Waste Collection No. WCP/CK//08/0578 South Coast

N/A N/A Disposed by: Sava GMBH, Germany


Waste Description EWC Code Quantity Tonnes/Year




Batteries Dry & Lead 16 06 01* 16 06 05

0.00 Returnbatt, Co Kildare Waste Permit No.W0192/03 Waste Collection Permit No. WCP/DC/09/1192/01

N/A Recycled by: Returnbatt

N/A

Waste Oil 13 01 10* 13 01 09

6.13

Atlas Oil, Co. Laois Waste Permit No: 184-1 Waste Collection Permit No. WCP/EC/08/1116/01

N/A Recycled by: Atlas Oil

N/A

IPA organic solvent 14 06 03* 4,339.19

Enva/Indaver N/A Recycled by: SRM, Sunderland PPC Permit BV4673IM

N/A

Propylene Glycol 07 05 04* 425.26 Enva/Indaver N/A Recycled by: SRM, Sunderland PPC Permit BV4673IM

N/A

Non Hazardous Liquids

07 01 01* 07 05 13

4.81

Veolia /Waste Permit No: W0050-2 Waste Collection No. WCP/CK/08/0578

N/A N/A Disposed by: Remondis Sava GMBH, Germany


Table 1.6: Annual Non-Hazardous Waste Arising 2010





General Inclusive of Shredding Waste

20 03 01 20 01 39

453.64 Collected by: Greenstar Waste Collection No: WCP/DC/08/1120/01

N/A N/A

Connaught Residual Landfill WO 178-01

WEEE Including Visual Display Units

20 01 36 4.3

Greenstar WCP/DC/08/1120/01

N/A Recovery/Recycled/ Reused as per WEEE Directive KMK Metal Recycling Permit No: WO113-03

N/A

Cardboard 20 01 01 327.3

Collected by: Greenstar Collection Perm WCP/LK/31005B

N/A Recycled by: Marwin Broker Number IRE-G027-08

N/A

Secondary Cartons

15 01 02 117.6

Collected by: Greenstar Collection Permit WCP/DC/08/1120/01

N/A Recycled by: Marwin Broker Number IRE-G027-08

N/A






Foil 20 01 40 31.8 Greenstar Collection Permit WCP/LK/31005B

N/A Recycled by: Marwin Permit IREGO27/08

N/A

Timber 20 01 38 166.0 Collected by: CF Sheeran WCP-DC-09-1171 -01

N/A Recycled by: CF Sheeran WCP-DC-09-1171 -01

N/A

Metal Waste 20 01 40

57.8 Collected by: PJ Hegarty & Sons/ Waste Permit No: WP-05-04 Waste Collection No: WCP/LK/08-589-01

N/A Recycled by: PJ Hegarty & Sons

N/A

Plastic Packaging & Containers

15 01 02 83.2 Collected by: Greenstar Collection permit WCP/LK/08-589-01

N/A Recycled by: Greenstar in Cork

N/A

Paper 20 01 01 5.9 Rehab/Waste Permit No: 08/04 Reg. No. 635 Waste Collection No. CK.WMC.146/03 WCP/LK/119/05c Licence No. 03/07635

N/A Recycled by: Rehab

N/A

Vegetable Oil

20 01 25 4.8 Collected by Frylight WCP/MO/09/0624/01 Waste Collection No: WCP/LK/176/06c

N/a Recycled by: Power Generation UK & Europe

N/A






Dry Mixed Recyclables Paper/Cardboard/Plastic Steel Cans/Compost

20 01 01 12.6 Collected by: Greenstar WCP/DC/08/1120/01


AWS YNA1838807/CB Davis Recycling IREAG004/08 Hammond Lane CK(S) 456/08 O’Tooles WP01/07/A

PP/PS 15 01 02

3,610.6

Collected by Thorndale Permit Number WCP-LK-500-08b

N/A Recycled by: Thorndale

N/A

Grease Interceptor Waste

20 01 08

4.0

Collected by Lehane Environmental Grease Trap Waste Collection WCPLK0662B

N/A Recycled by: Milton Composting Facility WM-WP-28-03

N/A

Composted Material 20 01 08

19.9

Collected by Greenstar Collection Permit WCP/DC/08/1120/01

N/A Recycled by: Milton Composting Facility WM-WP-28-03

Agricultural Fetilizer

Empty Monomer IBC’s & Drums

20 01 39

16.0 Collected by Norman Lauder Agent

N/A Recycled by: Schutz UK WML 43575

N/A

Secondary Recovered 20 01 01

133.5 Collected by Greenstar Collection Permit WCP/DC/08/1120/01


N/A


1.9 Resource Consumption

1.9.1 Energy Consumption

The annual energy and water consumption is summarized in Table 1.7 below.

Table 1.7: Annual Energy Consumption 2010 Item Quantity 2009 Quantity 2010

Natural Gas 19,429.835 MWh -2009 34,486.371 MWh Electricity 72,367.990 MWh -

2009

65,109.660 MWh

Borehole water 257,804m3 240,774 m3 Mains water 62,883 m3 124,992 m3

The 2010 Energy Audit Summary for the facility is provided in Attachment No. 4. Therein various energy saving projects implemented during 2010 are detailed. There have been significant improvements in energy efficiencies in production.

1.9.2 Solvents

The bulk solvent used at Vistakon is Iso-Propyl Alcohol and Propylene Glycol. The Solvent Management Plan is provided in Attachment No. 9.

1.10 Environmental Incidents and Complaints

1.10.1 Environmental Notifications

There were a number of environmental notifications as per Condition 11.1 of the licence during 2010, these related to one incident of malfunctioning of monitoring equipment, and a small number of BOD/ COD exceedences - all were reported to the Agency and are summarized below in Table 1.8. The incidents involved did not result in any significant environmental releases.

Table 1.8: Summary of Environmental Notifications 2010 Date Notification

8th

January – 2nd

July 2010 BOD / COD notifications (25/01, 03/03, 01/04, 30/04, 04/06), – Water is discharged to Limerick County Council (LCC), LCC had agreed to increase BOD (from 700 to 1100 mg/L) and COD (from 1400 to 2000 mg/L) discharge concentrations for Vistakon increased production. The inclusion of these new discharge limits was pending in the revised IPPC Licence issued in July 2010. On-going notification was required until the new licence took effect.

12th

May 2010 Notification of malfunction of monitoring equipment. The FID unit on the TO Emissions shut down on the 11/05/10 at 17.00hrs. Root cause identified as related to the hydrogen supply pressure following an earlier automatic cylinder change over. FID Unit


came back on-line on the 12/05/10 at 10.00hrs.

24th

November – 25th

November 2010

Notification of lost continuous data. An extended power outage due to an electrical fault in an area of the plant housing the continuous monitoring PC / PLC on 24/11/10 has caused the loss of data from 13.20hrs on the 24/11/10 to 08.30hrs on the 25/11/10. The power back-up UPS system failed after 10 minutes. Unable to retrieve lost data.

15th

June 2010 BOD & COD result on weekly composite samples

10th

September 2010 BOD & COD result on weekly composite sample due to contaminated sample container

1.10.2 Environmental Complaints Seven complaints were received during 2010: (1) Date:06/01/10 Ref:01/2010 Complaint received from EPA – local resident complained of early morning noise. Area around facility checked for abnormal noise, noise levels checked at AN2 – noise levels found to be normal. A comprehensive noise survey had been undertaken during the December 2009 including a study of background noise levels during the plant shutdown. No significant issues were identified. Plan presented to install additional noise bunding to minimise background levels and prevent complaints. (2) Date: 28/01/10 Ref:02/2010 Complaint received from the EPA – local resident complaining of loud noise from plant, EPA Inspector visited site. Area around facility checked for abnormal noise, facility was operating as normal, noise from the facility could be heard at the Foley residence, this noise comes from the IPA utility yard, noise measurements undertaken in the area did not indicate any exceedence of licence conditions. However, in an effort to address the complaint additional noise bunding of fans in the area was agreed with the Agency. (3) Date:01/04/10 Ref:03/2010 Complaint received from the EPA – local resident complaining of noise, likely to be from Truck cleaning road near site perimeter. Full noise survey had been undertaken in March and all locations were found to be compliant. (4) Date:09/06/10 Ref:04/2010 Complaint received from the EPA – local resident complaining of noise, from the plant previous week-end. No noise issues identified on-site. Local farmer had cut silage in the field between plant and resident during the week-end. (5) Date: 18/06/10 Ref:05/2010 Complaint received from the EPA – local resident complaining of noise, plant external area surveyed no issues found. A full noise survey had been undertaken during May, to assess impact of additional bunding installed. Ambient noise levels had reduced from earlier surveys. All areas remain compliant with Licence conditions. (6) Date: 25/11/10 Ref:06/2010


Complaint received from the local resident complaining of emissions seen over the plant. This is the water vapor (steam) from the CCP plant visible during cold weather. This was explained to the person involved. (7) Date: 02/12/10 Ref:07/2010

Complaint received from the EPA – local resident complaining of noise, from the plant, plant external area surveyed no issues found.

2. Management of the Activity

2.1 Introduction

As part of the Environmental Management Programme an update of objectives and targets for the following environmental issues was undertaken and is presented in Table 2.1 below:


2.2 Status Report on Schedule of Objectives and Targets 2010

Table 2.1: Schedule of Objectives and Targets

Objectives Targets Outcome Responsible

Person

1 Environmental Awareness of Suppliers & Contractors

Ensure that all Contractors and high-risk suppliers are fully familiar with Johnson & Johnson Safety and Environmental requirements.

Contractor EHS Guidelines developed and booklet issued to all contractors at EHS induction and pre-start EHS meetings. Rigorous monitoring of contractor environmental performance during CCP construction program on-site 2010, construction site contractor was accreditated to ISO14001

EHS Manager

2 On-going compliance with IPPC Licence Conditions

Zero non-compliance with Licence conditions Zero government-issued violations Zero accidental releases

No major non-compliances of environmental signifigance during 2010. Revised IPPC Licence issued to include for CCP and geothermal cooling project. Extensive work to meet new IIPC licence conditions involving installation of monitoring equipment, extension of environmental monitoring programs and revision of environmental management and monitoring procedures. IPPCL tracker database established.

EHS Manager

3 Wastewater Zero non-compliance with Licence conditions Zero government-issued violations Zero accidental releases

Successful pilot study undertaken on oxidative treatment options to reduce organic load. Revised IPPC Licence limits issued. No major non-compliances of environmental signifigance during 2010.

EHS Manager

4 Noise Zero non-compliance with Licence conditions Zero complaints

No non-compliance with licence limits, a small number of complaints received, a number of noise surveys were undertaken, opportunities to further reduce ambient noise levels were identified, additional bunding costing in excess of €20,000 was

Facilities Director /EHS Manager


installed in response to complaints received to reduce ambient noise levels. Some 70,000 was spend on BAT attenuation on the fans associated with CCP installation to minimse noise levels.

5 Hazardous Waste Generation and Disposal

10% Absolute Reduction by 2010 (baseline 2007).

IPA solvent usage per lens produced has been reduced by 40% in the period 2007-2010. Environmental audits undertaken at waste disposal facilities during 2010.

Facilities Director /EHS Manager

6 Water Consumption 10% Absolute Reduction by 2010 (baseline 2007).

A series of water use reduction projects undertaken in production during 2010, in the period 2007-2010 water use per lens produced has been reduced by 30%. Water awareness campaign undertaken with all employees.

Facilities Director

7 Energy use and conservation

To ensure that we can where possible minimize the amount of energy used in production and support areas.

Significant energy and CO2 projects commissioned/constructed in 2010 including CCP and geothermal cooling. Energy use per lens produced has been reduced by 25% in the period 2007-2010. Site won J&J Worldwide Sustainability Award for Energy Excellence. Energy awareness campaign undertaken with all employees.

Facilities Director

Environmental Management Plan 2011

The environmental objectives and targets for 2011 and the associated environmental management plan to achieve same during 2011 is outlined below. The O&T were developed following the annual environmental review of the register of aspects and impacts and 2010 performance. The 2010 objective on environmental awareness of suppliers and contractors was considered closed in 2010 and now part of routine activities and is not included in the 2011 plan.


EMP Objective Number: 1

On Going Compliance with IPPC Licence Conditions.

Aspect No. 001 in the Site Environmental Review received a Rating of 5,000 in the Aspects & Impacts Meeting for 2011.

Target: Zero non-compliances with Licence conditions, Zero government-issued

violations, Zero accidental releases Rationale:

IPPC Licence requires compliance with it’s conditions, J&J MAARS standard also requires compliance with local regulatory standards.

Timeframe: Ongoing through 2007 - 2012

Measure: Zero non-compliances with Licence conditions, Zero EPA-issued violations,

Zero accidental releases

Responsibility: Facilities Director/EHS Manager

Resources Required: EHS & Facilities Maintenance Personnel involved in continuous monitoring,

control and vigilance.

Actions: The activities during 2011 include:

Training on Licence Compliance as part of the Induction Training. Training on Licence compliance requirements for facilities personnel. Annual Awareness Training for all employees. Routine measurement and monitoring of environmental data. Ongoing development of Environmental Management System. EHS to review monitor and trend results weekly Testing/Calibration and maintenance of equipment to ensure that we comply with specification of the IPPC Licencing requirements. New equipment will also be investigated. On-going reviews of site activities via internal audits to ensure compliance. Use IPPC tracker database to monitor progress.



Wastewater

Aspect No. 023 in the Site Environmental Review received a Rating of 5,000 in the

Aspects & Impacts Meeting for 2011.

Target: Zero non-compliances with Licence conditions

Zero government-issued violations Zero accidental releases

Rationale:

Company goals developed from IPPC Licence, Site Environmental Review, Register of Aspects and Impacts and the Healthy Planet 2010 Goal.

Timeframe: Ongoing through 2017-2012

Measure: Zero non-compliances with Licence conditions Zero government-issued violations Zero accidental releases

Responsibility: EHS Manager/Facilities Manager

Resources Required: EHS & Facilities Maintenance Personnel involved in continuous monitoring,

control and vigilance. Actions: The activities during 2011 include:

Routine measurement and monitoring of wastewater data. EHS to review monitor and trend results weekly Testing/Calibration and maintenance of continuous monitoring equipment to ensure that we comply with specification of the IPPC Licencing requirements. Investigate feasibility of on-site treatment of wastewater to reduce load, complete lab and pilot scale studies and commence design and construction.



Noise


Target: Zero non-compliances with Licence conditions

Zero complaints

Rationale:

Company goals developed from Site Environmental Review, Register of Aspects and Impacts and IPPC Licence


Measure: Zero non-compliances with Licence conditions Zero complaints

Responsibility: EHS Manager/Facilities Manager

Resources Required: EHS Resources & finance for any additional noise control

Actions: Activities for 2011 are: Conduct Annual Noise Survey, Identify appropriate opportunities to minimise noise from process equipment and implement abatement solutions where feasible. Identify any opportunities to reduce ambient noise at site perimeter and implement abatement solutions where feasible. Develop noise awareness program for facilities personnel.



Hazardous Waste Generation and Disposal.


Target: 10% absolute reduction of total waste generation (hazardous and non-hazardous waste disposal) and waste use by 2015, baseline 2010.

Rationale:

Company goals developed from Site Environmental Review, register of Aspects and Impacts.


Measure: SRM in the UK are receiving our waste IPA/PG and it is being recycled and used in another process. Progress to a recovery solution where possible. Reduce volume of waste sent to landfill.

Responsibility: EHS Manager/Engineering Manager /Lean Manager

Resources Required: EHS Personnel

Actions: Activities for 2011 are:

Audit Hazardous Waste Facilities Implementation of process improvements for alternative/less volatile solvent on production lines. Process optimization to reduce monomer use. Integrate and support with waste element of lean six sigma projects.



Water Consumption

Aspect No. 004 in the Site Environmental Review received a Rating of 1200 in the Aspects & Impacts Meeting for 2011.

Target: 10% reduction by 2015, baseline 2010. Best practices evaluation.

We will continue to ensure that we can where possible minimise

the amount of water used in production and support areas.

Rationale:

Company goals developed from Site Environmental Review, register of Aspects and Impacts and the Healthy Planet 2015 Goal.

Timeframe: Ongoing through 2010 - 2015.

Measure: To ensure that we can where possible minimise the amount of

Water used in Production and Support areas.

Responsibility: Facilities Director/ EHS Manager/Engineering Manager

Resources Required: On going with Facilities and Engineering & Operations Personnel

Actions: Activities for 2011 are: On-going projects with the Facilities and Engineering Teams to address water use and reduction plant wide and to minimize usage where possible. Further implementation of hydration water use reduction initiative. Water awareness campaign for all employees during 2011. Water reduction suggestion scheme for all employees. Installation of additional monitoring meters in Facilities to track usage.



Energy Use and Conservation

Aspect No. 002 in the Site Environmental Review received a Rating of 1200 in the Aspects & Impacts Meeting for 2011.

Target: To ensure that we can where possible minimise the amount of

Energy used in Production and Support areas. 10% reduction in facility CO2 emissions by

2015. Increase onsite clean-tech energy capacity to 5 MW

Rationale: Company goals developed from Site Environmental Review, register of Aspects and

Impacts, Annual Energy Report for IPPC Licence and the Healthy Planet 2015 Goal.

Timeframe: Ongoing through 2010 -2015.

Measure: To ensure that we can where possible minimise the amount of Energy used in

Production and Support areas. Monitor in monthly & annual facilities reports

& AER. Evaluate additional clean energy options.

Responsibility: Facilities Director/EHS Manager/Engineering Manager

Resources Required: On going with Facilities/Engineering/EHS Personnel

Actions: On-going projects with the Facilities and Engineering Teams to address energy usage and reduction plant wide during 2011:

Facilities and production investigations to identify options for energy reduction and implementation where feasible Monthly EHS focus topic. Employee suggestion scheme and awards to be implemented. Weekly statistics to be issued by facilities to all employees. Benchmarking performance in SEI large energy users group and J&J Campus Ireland. Wind energy project feasibility to be completed.


3. Pollution Release and Transfer Register (PRTR)

The PRTR report will be submitted electronically as part of the AER electronic submission form. Copies of the data are provided in Attachment No. 6.

4. Bund Integrity Assessment Report

A site bund integrity assessment report was completed and submitted in the 2008 AER, testing frequency is every three years- due 2011.

5. Tank and Pipeline Testing and Inspection

An inspection for leaks on all flanges and valves on over-ground pipes used to transport materials other than water is carried out weekly and findings recorded. All underground pipelines are to be inspected at least once every three years the last inspection occurred in December 2009. No significant issues were found.

6. Environmental Liabilities and Residual Management

The ELRA and Residuals Management Plan were originally submitted to EPA in September 2008.

These have been reviewed as per conditions 10.2 and 12.3 of the IPPC Licence. A copy of the

amended reports is presented in Attachment No. 7.

7. Licence Specific Reports

The following reports are included as Attachments to this Report:

Attachment 1 Environment, Health & Safety Policy Attachment 2 ISO14001 Certification Attachment 3 Air Emission Data Attachment 4 Summary Energy Audit Report Attachment 5 Fire Water Risk Assessment Attachment 6 Summary of Emissions and Waste PRTR Attachment 7 Decommissioning Management Plan & ELRA Attachment 8 Groundwater Monitoring Data Attachment 9 Solvent Management Plan

Vistakon Ireland Ltd AER 2010 IPPC Licence Compliance

AER Attachment No. 1: Environment, Health & Safety Policy

The EHS policy is as follows:

EEnnvviirroonnmmeenntt,, HHeeaalltthh && SSaaffeettyy PPoolliiccyy We are committed to protecting the health and safety of our employees, contractors and visitors and preserving our environment. It is our goal to provide an injury and illness free workplace, prevent pollution and achieve healthy lifestyles. Environment, Health & Safety (EHS) is an operational function that impacts the productivity, quality and profitability of the organization. In support of this commitment: • Health, safety and preserving the environment are the responsibilities of each employee. • Senior Leaders will provide the vision, focus and resources to ensure that safe, healthy and

sustainable practices are central to all activities on site. • Senior leaders will manage and monitor EHS efforts as they would any other operational

function. EHS objectives and targets will be set and reviewed for continuous improvement by reducing the environmental, health and safety impacts of our processes and products.

• We are committed to operating in compliance with all applicable regulatory and J&J Corporate EHS standards.

• Information instruction, training is provided to ensure all employees possess the knowledge and skill required for the healthy and safe performance of their work with minimum environmental impact and to promote their involvement and accountability in EHS activities.

• We strive to create products and processes that are inherently safe and that incorporate the principles of pollution prevention, waste minimization, energy efficiency and process safety.

• We maintain and periodically test the Emergency Response Plan. • We provide an occupational health service that includes physical and psychosocial health needs

such as; absence & disability management, employee assistance, health & wellness. • We strive to ensure that the site’s environmental footprint is minimised by purchasing

sustainable resources and energy where practicable. • We promote the use of the health & safety, environmental and energy management systems by

suppliers and contractors. • Where accidents or incidents do occur; we take prompt corrective action, investigate root

causes, actively seek to prevent recurrences and disseminate experiences learned. • We support EHS awareness and education based programs within the community.

We must consider EHS in every decision we make and in every activity we perform. We care about the health and safety of our fellow employees, their families, their communities, our customers, contractors and visitors. We operate in a manner, which minimises adverse impact on employees, local community and environment, utilising energy and other resources responsibly and efficiently.

Signed: _______________________________ Date : ____________________ GENERAL MANAGER


AER Attachment No. 2: ISO14001

Certification


AER Attachment No. 3: Air Emission Data

Margaret Stokes

Vistakon

National Technology Park

Limerick

Work carried out on: 26th

October 2010

Job No: 5005_Vistakon_Annual

By Mr. Jon Connor

Report Approved by:

Mr. Jon Connor

Senior Environmental Consultant

MCERTS Level 2

___________________________

Report of the Emissions Monitoring carried out at Vistakon – Limerick

VISTAKON City Analysts Ltd

October 2010 Environmental

Report: VISTAKON_5005_Annual Page 2 of 8

1.0 INTRODUCTION

City analysts were requested to carry out an emissions monitoring survey on a Boiler

by Vistakon at thier site in Limerick. The survey was carried out over one day. The

Boiler was monitored on the 26th October for combustion gases. The installation ran

normally during the monitoring.

2.0 METHODOLIGY

The Methods used for the monitoring survey and the parameters sampled for are

detailed in table 2.1 below:

Table 2.1 Monitoring Method

Emission

Point Ref Parameter Method Analysis

Boiler

A3-58

Oxygen ISO 12039 Electro Chemical

Cell

Oxides of Nitrogen ISO 10849 Electro Chemical

Cell

Carbon Monoxide ISO 12039 Electro Chemical

Cell

2.1 Monitoring of emissions to the atmosphere

Sampling was carried out by Mr. Jon Connor, a member of the technical staff from City

Analysts Air Monitoring Department, who has MCERTS Level 2 personnel

certification. MCERTS Registration no: MM 04 526. All sampling was carried out in

strict accordance with recognised standard procedures as detailed below.

2.2 Combustion gases - O2, CO, CO2 and NOX (as NO2)

To determine the individual gases present in the stack gas stream sampling was

undertaken in accordance with the procedures in ISO 12039 and ISO 10849. The

analyser used was a testo 350 xl electro chemical cell. The analyser was calibrated at the

start of each run and again at the end of each run. Ambient air was used to Zero the

analyser and also to span the analyser Oxygen reading. Averaged one minute readings




were taken over a period of 30 minutes for each run. The results are expressed in

mg/Nm3 and Kg/hr.

2.3 Volume Flow

The volume flow was determined using an S-type pitot tube and K-type

thermocouple.

3.0 SAMPLING RECORD

The times of the sampling are detailed in table 3.1

Table 3.1 Sampling Record of A3-58

Run

No Date and Time

Parameter

1 26th October 15:10 – 15:40 TOC and Combustion gases




4.0 RESULTS The results of the monitoring are detailed in table 4.1 and 4.2 below:

Table 4.1 30 Minute Averages

Time O2 CO NOX Flue Temp

hh:mm % ppm ppm °C

15:10 – 15:40 6.02 3.1 29 111.3

(Actual) Average Stack Velocity 8.5 m/s Stack Diameter 0.6 m (Actual ) Volume Flow 8,696 m3/hour (Normalised) Volume Flow 6,164 Nm3/hour

Table 4.2 30 Minute Averages (All concentrations expressed at

273K, 101.3kPa dry gas, 3% Oxygen Reference)

Time CO CO NOX NOX

hh:mm mg/m3 Kg/hr mg/m3 (as NO2) Kg/hr

15:10 – 15:40 4 0.02 60 0.37




Appendix - Work Sheets




Volume Flow

CLIENT Vistakon OPERATORS JC/SC

SITE Limerick DATE 26/10/2010

Date 26/10/2010

Stack ID A3-58

Operator JC/SC

Stack Diameter/cm 60

Barometric Pressure/kPa 101.3

Static Pressure/Pa -135

Position in stack/cm Pressure/Pa Temp/°C

55 32 111

54 31 113

48 39 112

42 34 111

36 37 114

30 33 113

24 32 112 T/289 1.33218

18 31 110 100000/100000+Ps 1.001352

12 29 111 Std Press/Barom 1.000247

5 37 113 Stack Area 0.282743

Averages 33.5 112 273/T 0.709091

Actual Stack Velocity 8.54 m/s

Actual Volume Flow 8696.24 m3/hr

Normalised Vol Flow 6164.90 Nm3/hr

STACK VELOCITY = D x ((T/289) x (100000/100000+PS) x (Pv))^0.5

D = Density of air (1.291 kg/m3 at 289K)

T = Stack Temp (K)

PS = Static Pressure (Pa)

Pv = Pressure in Stack (Pa)




Testo Zero



Zero Span

Time CO Value/ppm CO Reading/ppm NOX Value/ ppm NOX Value/ ppm O2 Value/ % O2 Reading/ %

15:00 0 0 0 0 20.9 20.42

15:50 0 0 0 0 20.9 20.93

Ambient air was used for the span and zero




Data



Time O2 CO CO2 NOX SO2 Flue Temp

hh:mm % ppm % ppm ppm °C

15:10 5.21 1 7.93 30 1 113

15:11 6.18 1 8.22 30 1 112

15:12 5.12 1 6.37 36 1 113

15:13 6.18 13 7.98 28 0 109

15:14 5.17 4 7.86 30 0 117

15:15 6.18 1 5.68 30 0 115

15:16 5.28 1 8.39 41 1 114

15:17 6.27 5 4.63 41 1 118

15:18 5.21 1 4.34 35 0 106

15:19 6.26 11 4.40 35 0 106

15:20 5.26 1 3.87 68 0 109

15:21 6.27 1 4.41 78 1 108

15:22 5.13 1 3.74 24 1 115

15:23 8.33 1 3.50 12 1 106

15:24 5.23 7 3.54 12 1 113

15:25 5.23 1 3.09 2 0 119

15:26 6.25 1 3.24 2 0 113

15:27 5.28 1 3.26 8 0 111

15:28 4.19 11 3.90 19 0 110

15:29 8.25 5 4.36 20 0 111

15:30 6.32 1 4.20 22 1 112

15:31 5.22 2 5.54 23 1 109

15:32 6.38 1 4.73 14 1 110

15:33 5.28 6 4.94 47 0 113

15:34 6.39 1 4.89 24 0 112

15:35 5.18 6 4.52 35 0 110

15:36 6.95 1 4.51 22 1 110

15:37 7.43 1 3.65 37 1 109

15:38 7.40 3 3.80 36 1 110

15:39 6.30 1 2.97 34 1 107

15:40 7.36 1 3.05 37 0 107

AVERAGE 6.02 3.08 4.82 29.44 0.53 111.34

Margaret Stokes

Vistakon

National Technology Park

Limerick

Work carried out on: 26th

October 2010

Job No: 5005_Vistakon_Generatord

By Mr. Jon Connor

Report Approved by:

Mr. Jon Connor

Senior Environmental Consultant

MCERTS Level 2

___________________________

Report of the Emissions Monitoring carried out at

Vistakon – Limerick



Report: VISTAKON_5005_Generators Page 2 of 11

1.0 INTRODUCTION

City analysts were requested to carry out an emissions monitoring survey on two

generators by Vistakon at their site in Limerick. The survey was carried out over one

day. The generators were monitored on the 26th October for combustion gases. The

installations ran normally during the monitoring.

2.0 METHODOLIGY

The Methods used for the monitoring survey and the parameters sampled for are

detailed in table 2.1 below:

Table 2.1 Monitoring Method

Emission

Point Ref Parameter Method Analysis

Generators

A3-106

&

A3-107

Oxygen ISO 12039 Electro Chemical Cell

Oxides of Nitrogen ISO 10849 Electro Chemical Cell

Carbon Monoxide ISO 12039 Electro Chemical Cell

2.1 Monitoring of emissions to the atmosphere

Sampling was carried out by Mr. Jon Connor, a member of the technical staff from City

Analysts Air Monitoring Department, who has MCERTS Level 2 personnel

certification. MCERTS Registration no: MM 04 526. All sampling was carried out in

strict accordance with recognised standard procedures as detailed below.

2.2 Combustion gases - O2, CO, CO2 and NOX (as NO2)

To determine the individual gases present in the stack gas stream sampling was

undertaken in accordance with the procedures in ISO 12039 and ISO 10849. The

analyser used was a testo 350 xl electro chemical cell. The analyser was calibrated at the

start of each run and again at the end of each run. Ambient air was used to Zero the

analyser and also to span the analyser Oxygen reading. Averaged one minute readings

were taken over a period of 30 minutes for each run. The results are expressed in

mg/Nm3 and Kg/hr.




2.3 Volume Flow

The volume flow was determined using an S-type pitot tube and K-type

thermocouple.

3.0 SAMPLING RECORD

The times of the sampling are detailed in table 3.1

Table 3.1 Sampling Record

Stack

Ref Date and Time

Parameter

A3-107 26th October 13:15 – 13:45 Combustion gases

A3-106 26th October 13:50 – 14:20 Combustion gases




4.0 RESULTS The results of the monitoring are detailed in table 4.1 and 4.2 below:

Table 4.1 30 Minute Averages

Stack Ref O2 CO NOX Flue Temp

% ppm ppm °C

A3-107 11.57 470 91 118

A3-106 13.26 342 94 119

Table 4.2 Volume Flow and Temperature

Stack Ref

Volume Flow Actual

Volume Flow Normalised Flue Temp

m3/hr Nm3/hr °C

A3-107 8,603 5,999 118

A3-106 9,246 6,460 118

Table 4.3 30 Minute Averages (All concentrations expressed at

273K, 101.3kPa dry gas, 6.5% Oxygen Reference)

Stack Ref CO CO NOX NOX

mg/m3 Kg/hr mg/m3

(as NO2) Kg/hr

A3-107 587 3.80 188 1.21

A3-106 427 2.56 193 1.16




Appendix - Work Sheets




Volume Flow A3-107



Date 26/10/2010

Stack ID A3-58

Operator JC/SC





55 180 116

54 178 117

48 176 117

42 198 118

36 193 119

30 186 118

24 176 117 1.351557

18 174 117 1.017294

12 175 118 T/289 1.000247

5 187 119 100000/100000+Ps 0.125664

Averages 182.3 117.6 Std Press/Barom 0.698925

Stack Area

Actual Stack Velocity 20.44 m/s 273/T





T = Stack Temp (K)






Testo Zero A3-107



Zero Span


13:00 0 0 0 0 20.9 20.77

14:30 0 0 0 0 20.9 20.56

Ambient air was used for the span and zero




Data A3-107




hh:mm % ppm ppm °C

13:15 10.41 496 89 124

13:16 10.96 512 102 123

13:17 12.59 492 85 120

13:18 12.25 456 94 116

13:19 12.45 508 91 127

13:20 12.84 408 90 124

13:21 11.34 460 90 124

13:22 12.14 500 100 125

13:23 12.06 520 84 115

13:24 10.93 420 98 115

13:25 12.76 472 97 115

13:26 12.48 496 81 114

13:27 10.61 428 89 125

13:28 12.89 476 89 117

13:29 10.69 516 102 119

13:30 10.44 496 91 129

13:31 11.57 456 90 123

13:32 10.08 424 98 117

13:33 10.66 484 97 119

13:34 12.84 516 87 118

13:35 10.05 460 86 122

13:36 10.77 416 82 116

13:37 11.09 444 81 118

13:38 10.32 400 94 121

13:39 11.57 476 85 124

13:40 11.14 448 98 120

13:41 13.04 468 102 119

13:42 12.52 476 100 119

13:43 11.28 428 87 116

13:44 12.69 512 94 114

13:45 11.29 504 82 115

AVERAGE 11.57 469.94 91.43 119.68




Volume Flow A3-106



Date 26/10/2010

Stack ID A3-58

Operator JC/SC





55 161 117

54 154 119

48 176 120

42 149 121

36 153 119

30 162 119

24 170 119 1.354325

18 152 115 1.017294

12 155 117 T/289 1.000247

5 143 118 100000/100000+Ps 0.125664

Averages 157.5 118.4 Std Press/Barom 0.697496

Stack Area

Actual Stack Velocity 19.02 m/s 273/T





T = Stack Temp (K)






Testo Zero A3-106



Zero Span


13:00 0 0 0 0 20.9 20.77

14:30 0 0 0 0 20.9 20.56




Data A3-106




hh:mm % ppm ppm °C

13:50 12.06 375 90 124

13:51 12.31 321 93 123

13:52 12.61 330 98 120

13:53 12.19 366 97 116

13:54 14.12 309 95 127

13:55 15.09 309 90 124

13:56 12.21 372 95 124

13:57 15.13 318 96 125

13:58 13.81 381 92 115

13:59 11.92 339 94 115

14:00 15.25 360 95 115

14:01 14.80 363 89 114

14:02 13.38 309 98 125

14:03 14.13 390 99 117

14:04 12.59 333 96 119

14:05 11.68 312 98 129

14:06 14.27 303 94 123

14:07 12.24 378 94 117

14:08 12.50 381 92 119

14:09 14.82 324 95 118

14:10 10.09 315 89 122

14:11 13.42 333 97 116

14:12 11.48 306 93 118

14:13 11.96 336 95 121

14:14 12.39 339 96 124

14:15 12.71 345 95 120

14:16 14.36 384 90 119

14:17 15.11 357 90 119

14:18 14.68 312 89 116

14:19 14.91 372 95 114

14:20 12.89 327 93 115

AVERAGE 13.26 341.95 93.92 119.68


AER Attachment No. 4: Summary Energy Audit Report

- 1 - Vistakon Energy Audit 2010

Energy Audit Summary Report 2010


1.0 Introduction This Energy audit was in accordance with EPA Guidance Note on Energy efficiency Auditing (2003). The report gives a general overview of the major energy (gas and electricity) consumers on the Vistakon site and reports on the usage levels over the past two years. Vistakon Ireland, as a subsidiary of the Johnson & Johnson group, are tackling energy usage and efficiency on many fronts. There is an annual Johnson & Johnson World Wide CO2 Fund that is available to fund energy projects. Every year the Vistakon Energy Team identifies and bids for project funding. The main electrical users on site consists on the main production power for the production lines (32% of site load), the compressed air (16%) to drive the lines and the nitrogen generation plant (15%). The main focus on site is to look at ways to reduce these main users and investigate a more efficient way to control the plant and to deliver the required load at a reduced cost. Vistakon have invested heavily in metering of their electrical load, with all main outgoing LV circuits being metered. This allows the demand profile to be carefully managed. Virtual electrical meters have been developed which group together all the plant associated with a particular load types, and totalises these figures. This metering system and other metering data reports to the BMS (Building Management System) and is used to developed Key Performance Indicators (KPIs) which are maintained weekly and any unusual trends are investigated and rectified. The gas usage is also closely monitored to ensure the boiler plant is running as efficiently as possible. Utilities such as Nitrogen and Compressed Air are fed directly to the production lines. These are all individually monitored. These figures are sent on a weekly email to the key production personnel who investigate high users identified from the metering data. A number of recommendations for energy reduction have been made. These projects are planned to be delivered in 2011.

2.0 Energy Consumption 2010 2.1 Electrical Vistakon’s current Maximum Import Capacity (MIC) from the ESB network is 10.3MVA or 10,300 kVA. This has grown steadily as the factory developed with the addition of more production lines and production line optimisations. The demand profile is very flat both day and night. The summer load is actually higher with the increase in the chilled water plant and the cooling towers that serve the compressors and the chillers on site.


In 2007, the actual total electrical energy demand consumed on site was 63,385,310 kWh or 63.4 Giga Watt hours. In 2008, the actual total electrical energy demand consumed on site was 72,555,311 kWh or 72.5 Giga Watt hours. In 2009, the actual total electrical energy demand consumed on site was 72,367,990 kWh or 72.3 Giga Watt hours. In 2010, the actual total electrical energy demand consumed on site was 72,422,660 kWh or 72,422 Giga Watt hours, of which: ‐65,104,260 kWh or 65,104 Giga Watt hours were imported from ESB network, ‐7,318,400 kWh or 7,318 Giga Watt hours were generated on site from CCP Plant. Vistakon installed a gas engine Combined Cooling & Power (CCP) Plant during 2010, which have came on line September 2010. This generates 2950 kWh of electrical energy per hour. Figure 1 shows the actual energy import (imported from ESB network) over the past four years, 2007, 2008, 2009 and 2010. The four traces on the graph show the actual use for 2007, 2008, 2009 and 2010. A large drop in energy imported can be seen since CCP Plant came on line in September 2010. For 2011 our predicted import from the ESB network will be in the region of 48,131,180 kWh or 48.1 GWh of electric power. Total electricity generated on site from the CCP will be in the region of 24,291,480 kWh or 24,291 GWh of electric power (assuming uptime of 94%).


Figure 1: Electricity Import 2007‐2010


2.2 Gas Usage on Site The site has three main boilers that are capable of delivering 5000 kg per hour of steam each. The boiler’s main purpose is to provide steam for the hydration cells across the site. They also provide heating for the water tanks in the water room and heating for the HVAC system. There is also a gas supply to a Thermal Oxidiser (TO) in the IPA tank farm area that treats the solvents used in the 3GT lines. The gas consumption of the TO is very low in comparison to the main site boilers. The gas supply also feeds the kitchen area located at the front of the building and a low pressure hot water boiler. In 2010, a combined Cooling and Power plant was commissioned, this plant will provide some 30% of the electrical requirement for the site and is gas powered. This is a much more energy efficient method of electricity generation. Table 2 showing the gas consumption of the three gas consumers across the site. Typical usage level per

week Typical usage in kWh (Calorific value of 39MJ/m3 Conversion factor ~~ 11)

Main site boilers (3‐off) 38,000 m3 418,000 kWh Thermal Oxidiser 500 m3 5500 kWh Kitchen 185 m3 2035 kWh CCP 109,090m3 1,200,000

Table 2: On site gas consumption 3.0 Energy Management & Reporting Systems The main site electrical demand is monitored by the ESB Energy Tracked system. This provides reports every 15 minutes on the Energy PC in the FAC department. The site has 11 distribution transformers across the 4 phases. Each main feeder from the transformer has an energy meter, which provides the total load for that individual low voltage (LV) switch board. All outgoing circuits from the main LV board have their own energy meters fitted and these all report back to the main Energy Management PC. The software allows for each of these meter outputs to be configured into “virtual meters”. These virtual meters allow all the electrical power used to provide the different utilities to the site to be monitored. The virtual meter that are used are listed below:‐

1. Total compressed air plant 2. Total nitrogen plant 3. Total chiller plant 4. Total AHU plant


5. Total motor control plant (all site Motor Control Cabinets (MCC)) 6. Total lighting and small power 7. Total production power for each phase individually 8. Total production power for the entire plant

These meters are used on a daily basis to monitor the site load and ensure that plant is operating as efficiently as possible. There are typical profiles for each virtual meter and any deviation from this profile will be investigated and rectified. Vistakon also has an extensive Building Management System (BMS), which monitors and controls everything from the temperature of the offices to the operation of all of the critical utilities on the site. Extensive metering has been invested for the mechanical services across the plant reporting to the BMS. A summary of site electrical usage is shown below:

Figure 2: Breakdown of utilities usage The Facilities department reviews the energy Key Performance Indicators (KPIs) on a weekly basis. This ensures that that any changes to the trends are identified and rectified. The Compressed Air and Nitrogen usage levels are two areas that are given close attention as the levels of use can vary significantly from line to line. The Facilities Department send weekly emails to the key production staff and senior managers to keep everyone’s mind focused on the energy costs associated with running the production lines.

4.0 Energy Reduction & Efficiency Projects 2010 and 2011


The tables below provide data on projects competed during 2010 and those planned for 2011 to reduce energy consumption(Tables 6.1 & 6.2). As part of the Johnson & Johnson worldwide energy saving budget, every year Vistakon is funded for energy saving projects, both to reduce the cost of running plant and to reduce the carbon footprint of the site. Below (Table 6.1) is a list of projects that were undertaken and delivered in 2010.


Table 6.1 Energy Projects Completed at Vistakon – 2010

Est Annual Saving Kwh Savings Code Project Title

€ $ Elec Gas

CO2 Saving (tonnes)

STATUS

E055 Conversion of additional AHUs to allow Free Cooling Confidential Confidential 1,394,998 0 934 COMPLETE

E057 Fit No 155 venturi orifice steam straps Confidential Confidential 0 686,279 124 ONGOING

E059 Construct & commission CCP Facility Confidential Confidential ‐ 0 6000 COMPLETE

E060 Install and commission geothermal cooling system Confidential Confidential ‐ 800 Complete Q1 2011

E070 Roll out 4 bar pressure to Lines � Confidential Confidential 510,000 0 341 ONGOING


Table 6.2 Energy Projects planned for in 2011 at Vistakon Below is a list of new Energy projects which Vistakon have applied to the Johnson & Johnson World Wide Engineering for funding to deliver them. Each Energy project has a project charter which outlines key milestone dates for the projects.

Est Annual Saving Kwh Savings Code Project Title

€ $ Elec Gas CO2 Saving (tonnes)

01 Replace Air Blowers in Hydration

Confidential Confidential 63,972 0 43

02 Hydration DI water heating (per line)

Confidential Confidential 40495 0 27

03 N2 leakage reduction modifications


04 Central vacuum systems

Confidential Confidential 235200 157

05 Upgrade energy management system


06 LED lighting trial 10 x 240W

Confidential Confidential 16,819 0 11

07 Feasibility on renewable wind project �

Confidential Confidential ‐ ‐ ‐

AER Attachment No. 5: Fire Water Risk Assessment

1 Vistakon Fire Water Risk Assessment Supplemental Report March 2011

Johnson & Johnson Vision Care Ireland

Fire Water Risk Assessment

Supplemental Report March 2011


Johnson & Johnson Vision Care Ireland

Fire‐Water Risk Assessment

Supplemental Report March 2011

Contents 1.0 Introduction .............................................................................................................................. 3 2.0 Overview of Firewater Retention Studies carried out to‐date................................................. 3 3.0 Method of Assessment of Environmental Risk......................................................................... 5 3.1 Fire Risk ............................................................................................................................ 5 3.1.1 Likelihood of Fire Occurring........................................................................................... 5 3.1.2 Consequences of a Fire .................................................................................................. 6 3.1.3 Overall Fire Risk............................................................................................................. 8

3.2 Environmental Risk........................................................................................................... 9 3.2.1 Likelihood of an environmental release ........................................................................ 9 3.2.2 Consequences .............................................................................................................. 10

3.3 Overall Environmental Risk................................................................................................. 12

3.3 Firewater Runoff Risk.......................................................................................................... 12

Attachment No.1 ‐ Firewater Environmental Risk Assessments(1‐17) ........................................ 14 Attachment No. 2 – 3D Emergency Map ...................................................................................... 24


1.0 Introduction Condition 3.9 of the sites Integrated Pollution Prevention & Control Licence (P0818‐02) requires: The licensee shall, re‐assess if the firewater retention facilities are sized in accordance with the Environmental Protection Agency Draft Guidance Note to Industry on the Requirements for Firewater Retention Facilities. A report on this reassessment shall be submitted to the Agency in the AER. This report provides for the re‐assessment of the fire water retention facilities as required by the IPPC Licence.

2.0 Overview of Firewater Retention Studies carried out to‐date Two previous fire water risk assessments have been carried out on‐site. These reports detailed

all major areas within the plant and described the materials used by Vistakon, the fire fighting

facilities, and the drainage systems. The total quantity of firewater likely to be applied in the

event of a fire was calculated in accordance with the methods described in the EPA Draft

Guidance Note to Industry on Requirements for the Establishment of Firewater Retention

Facilities. Recommendations were made for the protection of surrounding waters against

possible pollution from such an incident. In addition to this, the environmental risk was

assessed, taking into account fire load, fire risk and environmental load, and other factors

identified by the EPA in its draft Guidance Note. Finally, the impact of rainfall on a firewater

run‐off event was evaluated.

Firewater Runoff Study PM 2023‐23‐RP‐002 ‐ October 1996

A fire risk assessment was carried out to determine the possible effects of a run‐off in the event

of a fire at Vistakon’s site at the National Technology Park. The assessment concluded that:

• The management systems in place ensure the likelihood of a fire occurring in the first

place is minimized.

• The design features; firewalls, detection and alarm systems, sprinkler systems, etc.

ensure that the risk of fire growth and spread from one area to another is minimized.


• The 24 hour manning of reception and production areas, fire teams, emergency

response plan, etc. ensure prompt action is taken to mitigate the consequences of a

fire.

• The process areas drain to the trade effluent system which flows to the Castletroy

Wastewater Treatment Plant.

• The inventories of materials held within any section of site are well below the guideline

criteria used in the assessment for firewater retention in facilities storing/using water

hazardous material.

Final Conclusion – in view of the above, the risk of environmental damage due to firewater run‐

off is low and it is the opinion that there is no requirement for a firewater retention facility at

the site.

Fire Water Risk Assessment PM 011644.22.040 ‐ November 2007

The IPA Tanker Loading and Bulk Storage Area had been constructed at the facility to the plant

in 2007. As the use of IPA requires an IPPC licence, the firewater risk assessment was repeated

but only for to include the new area. The results of this assessment concluded that:

• Under the EPA Draft Guidance Note to Industry on the Requirements for Fire Water

Retention Facilities, a 60 minute fire event was assessed which resulted in a retention

requirement of 282m3.

• The Lörürl guide provides a method for calculating required fire water retention for

chemical storage areas.

• This method determined that the maximum required fire water retention capacity at

the site is 200m3.

• The current design allowed for 300m3 retention and was considered to be sufficient to

comply with both the Lörürl and EPA methodologies.

This supplemental report provides for the re‐assessment of the fire water retention facilities as required by the licence (P0818‐02).


3.0 Method of Assessment of Environmental Risk The methodology for this assessment has been developed with reference to the Environmental Protection Agency Draft Guidance Note to Industry on the Requirements for Fire‐Water Retention Facilities, 1995. Prior to commencing the assessment the site is logically divided into separate areas on the basis of significant distance and/or fire containment properties. Each of these areas is then assessed for the following:

1. Fire Risk which includes the likelihood of a fire occurring and the likely consequences of such a fire. 2. Environmental Risk which includes the likelihood of contaminated firewater runoff arising and reaching an environmental receptor and the likely consequences of such an event.

3.1 Fire Risk The elements of fire risk are assessed, i.e. the likelihood of the event occurring (in this case the likelihood of a fire occurring in the assessment area) and the consequence of the fire.

3.1.1 Likelihood of Fire Occurring

Three conditions are essential for a fire to occur: a fuel source, heat and oxygen. Normally the heat required is initially supplied by an external source, i.e. an ignition source, and then provided by the combustion process. If one of the essential conditions is missing then fire does not occur and, if one of these is removed, then fire is extinguished. Controlling each of these conditions reduces the likelihood of a fire occurring and each condition must be assessed in order to assess the likelihood of a fire occurring. Therefore the likelihood of a fire occurring depends on a variety of factors including the following: a) Nature of Materials Nature of the material which takes into account the presence of fuel sources in the assessment area. Fuel sources include:

• Flammables • Explosives • Oxidising Materials • Other Physio‐Chemical Properties • Combustibles


Definitions of the above fuel source types are provided in Appendix A. b) Ignition/Heat Sources The presence of heat/ignition sources in the assessment area, a contributing factor to which may be system controls. Factors which reduce the likelihood of an ignition source being present include:

• Ex rating/hazardous area classification • Permit to work system • Inerting systems • Earthing of equipment • No smoking policy • Procedural controls • Staff training

c) Oxygen Oxygen is generally present under most fuel storage, handling and use conditions. Some processes use gas inerting, e.g. nitrogen, to eliminate oxygen. In most cases the presence of oxygen is assumed. Once the facility‐specific information regarding factors which will affect the likelihood of a fire occurring has been assessed Table 1.1 can be used to determine that likelihood in terms of High, Medium and Low. Likelihood Factor High Flammable, oxidising or explosive materials present

and Potential for ignition source to be present

Medium Flammable, oxidising or explosive materials present and Low potential for ignition/heat source to be present or Combustible materials only present and Potential for ignition/heat source to be present

Low Combustible materials only present and Low potential for ignition/heat source to be present

Table 1‐1: Likelihood of Fire Occurring

3.1.2 Consequences of a Fire

The potential consequences of a fire can range from being relatively local to being significant. The extent and consequence of a fire will be influenced by the following variables:

• Quantity of flammable/oxidising materials in assessment area


• Fire detection and protection measures • Emergency response • Fire containment • Quantity and nature of firewater runoff generated

a) Quantity of flammable/oxidising materials in assessment area

The quantity of flammable/oxidising materials in the assessment area will be a contributing factor to determining the physical extent of the fire. The nature, thermal radiation levels generated and ability of the fire to spread will all be at least partially determined by the materials present in the assessment area. b) Fire detection and protection measures The purpose of fire detection systems is to identify fire as quickly as possible, thereby maximising effectiveness of fire fighting, and ensuring adequate time for evacuation. Elements of a fire detection/alarm system may include:

• Smoke detectors • Heat detectors • Manual call points • Breakable Glass Units (BGUs)

Fire protection provides immediate fire abatement for on‐site facilities. The more efficient the fire detection and protection features are, the less severe the consequences are likely to be. Fire protection facilities may include;

• Sprinkler system, consisting of reservoir, pumps and distribution network including deluge systems • Fire extinguishers • Hydrants • Other extinguishing media (foams, etc.)

c) Emergency response Efficiency of emergency response procedure can reduce consequences. Crisis management, emergency response training and awareness are preparation tools which improve emergency response. d) Fire containment Fire containment limits the spread of the fire, thereby reducing consequences. Fire containment is achieved by;

• Fire rated walls and structures prevent the spread of fire. These are generally rated to resist fire for a specific time period i.e. 1 & 2 hours.


• Distance between areas. A distance of 15 m should be retained between areas of flammable material storage. This will prevent the spread of fire.

e) Quantity and nature of firewater runoff generated The consequences due to firewater runoff (predominantly environmental) will be proportional to quantity of runoff generated. If large quantities of flammable liquid are present, there is potential for the firewater to spread the flammable material and escalate the fire. Once the facility‐specific information regarding factors which will affect the consequence of a fire has been assessed Table 1.2 can be used to determine that likelihood in terms of Severe, Moderate and Minor. Consequence Factor Severe Large quantities of firewater runoff generated

Poor fire detection/protection/emergency response system Large storage tank/container damage – release of hazardous materials Poor fire containment

Moderate Some quantities of firewater runoff generated Some fire detection/protection/emergency response system Some storage tank/container damage – release of hazardous materials Some fire containment

Minor Limited quantities of firewater runoff generated Good fire detection/protection/emergency response system Limited storage tank/container damage – release of hazardous materials Good fire containment.

Table 1‐2: Consequence of a Fire

3.1.3 Overall Fire Risk

The agreed likelihood and consequence categories determined for the fire hazard are combined, using the following matrix, to qualitatively predict the fire risk associated with each assessment area. Consequences Severe Moderate Minor

High High High Medium Medium High Medium Low

Likelihood

Low Medium Low Low Table 1‐3: Overall Fire Risk


3.2 Environmental Risk

The environmental risk is a combination of the likelihood of the event occurring (in this case the likelihood of contaminated firewater being discharged to the environment) and the consequence of the event on the environment.

3.2.1 Likelihood of an environmental release

The two principal factors affecting the likelihood of contaminated firewater being released to the surrounding environment are:

• The level of containment provided for materials in the assessment area • The pathways from the assessment area to environmental receptors

The level of containment provided for spillages and/or releases of a material in the event of a fire situation will affect the extent of contamination of the firewater and the migration potential of any contaminated firewater. A number of measures can contribute to a high level of containment on site including:

• Bunding of tanks and other material storage areas (e.g. drum stores) in accordance with recommended guidelines. • The use of spill containment equipment (e.g. spill pallets) for the storage of smaller quantities of materials. • Proper maintenance of all tanks, bunds and other material containing structures. • Procedural controls, e.g. emergency response procedures to contain and mitigate spillages and/or accidental releases of a material . • Maintaining appropriate equipment (e.g. adsorbent materials, booms) on site to contain any spillages and/or accidental releases of a material.

The pathway is defined as the physical route by which released materials (i.e. contaminated firewater) may travel from the source to an environmental receptor such as a receiving waterway. It is necessary to take into account all of the pathways by which the material may reach the environmental receptor. Potential pathways for contaminated firewater include:

• All water drainage systems on site including sewers, drains and culverts • Any damage to the site drainage systems which provide other potential pathways (e.g. cracked pipe work which allows firewater to drain to underlying soil and groundwater). • The surface area of the site if the volume of firewater exceeds the capacity of the site drains. • Areas of the site that do not have a hard surface or relatively impermeable cover (e.g. concrete) which would allow firewater to drain to the underlying soil and groundwater Factors which limit the potential pathways for contaminated firewater include:


Control mechanisms incorporated into the site drainage system (e.g. shut‐off valves) which can stop or divert the flow of firewater.

Impermeable surfaces on site to prevent firewater draining to the underlying ground and groundwater.

Once the facility‐specific information regarding factors which will affect the likelihood of firewater reaching an environmental receptor has been assessed Table 1.4 can be used to determine that likelihood in terms of High, Medium and Low. Likelihood Factor High No containment provided for spillages and/or accidental releases of materials

and Numerous pathways to environmental receptors

Medium No containment provided for spillages and/or accidental releases of materials or Some Pathways to environmental receptors

Low Containment provided for spillages and/or accidental releases of materials and Limited pathways to environmental receptors

Table 1‐4: Likelihood of contaminated firewater reaching an environmental receptor

3.2.2 Consequences

The factors influencing the consequences of firewater runoff to the environment are:

• The nature and properties of materials on site • The quantity of materials on site • The sensitivity of environmental receptors in the surrounding environment

a) Nature and Properties of Materials The nature and properties of the material on site will to a large extent determine the consequences of a release of the material to the environment. If the material does not possess any hazardous properties, it is unlikely to have any significant adverse impacts if released to the environment. Toxicological (eco) and associated classifications of a material can be used to assess the consequences of a release of the material to the environment. A number of physical, chemical and biochemical properties of the material influence the likely environmental fate of the material once it is released to the environment including:

• Water Solubility – Water soluble chemicals will more rapidly disperse in the environment and tend to be more biodegradable


• Octanol / Water Partition co‐efficient ‐ This indicates the relative solubility of the material in fatty materials. Fat soluble materials are more likely to bio‐accumulate in fatty tissues of fauna and are generally less biodegradable. • Bio‐accumulation Factor – This also indicates the bioaccumulation potential of the material • Bio‐dedegradibility –The more biodegradable the material the more rapidly it will be degrade in the environment and the less likely it is to have a long term impact • Volatility – indicated by Vapour Pressure and Latent Heat of Vaporisation –Volatile materials tend to evaporate and disperse more rapidly • Oxygen Demand of material (BOD) – Materials with high oxygen demand are likely to deplete the dissolved oxygen levels in an aquatic environment and thus have an adverse impact • The potential visual impact of a material (e.g. dyes, detergents, oil) on a receiving water body will be influenced by a number of physical and chemical properties such as colour, solubility, dispersal characteristics.

b) Quantity of Materials on Site The other key factor influencing the consequences of a release of a material to the environment is the quantity of material released. The larger the quantity of material released as contaminated firewater the greater the consequences on the environment will be. Additionally, there may be threshold quantities below which the escape to a watercourse may not have a significant environmental impact. c) Sensitivity of Environmental Receptors The sensitivity of the receiving environment / environmental receptors to which the contaminated firewater is discharged will also influence the consequences of the discharge. Therefore it is necessary to identify the receptors and assess the sensitivity of receptors in the surrounding environment. The presence and nature of the environmental receptor can be thought of as the fixed point in any hazard or risk assessment. Although the site operator is able to modify sources and, to some extent perhaps, on‐site pathways, altering the receptor is more difficult. Short of diverting rivers or moving abstraction points, there is usually little that can be done to change the receptors. The following criteria can be used to assess the sensitivity of environmental receptors in the surrounding environment.:

• Characteristics of aquifers in the area: − The vulnerability of the aquifer – Extreme (E), High (H), Moderate (M), Low (L) ‐ based on the Geological Survey of Ireland (GSI) classification system. − The importance of the aquifer – Regionally Important (R), Locally Important (L), Poor (P). − Aquifers located within Source Protection Zones.

• Rivers or other watercourses with a high fisheries potential including rivers designated as salmonid waters and as shellfish waters


• Rivers or other watercourses from which water is abstracted for drinking purposes. • Waters designated as bathing waters . • Areas covered by a scientific or conservation designation such as a Special Area of Conservation (SAC), a Natural Heritage Area (NHA), a Special Protection Area (SPA) or other conservation designation. • Areas covered by special amenity orders or other environmental or recreational designations in the local authority development plan

Once the facility‐specific information regarding factors which will affect the consequence of firewater reaching an environmental receptor has been assessed Table 1.5 can be used to determine that likelihood in terms of Severe, Moderate and Minor. Consequence Factor Severe Long term adverse environmental effects

Large quantity of hazardous materials released Materials reach sensitive environmental receptor(s)

Moderate Materials have medium term impact Medium quantity of hazardous materials released Materials have limited impact on environmental receptor(s)

Minor Materials are rapidly degraded and dispersed in the environment Small quantity of hazardous materials released Materials do not reach any sensitive environmental receptors

Table 1‐5: Consequences of contaminated firewater discharged to the environment

3.3 Overall Environmental Risk

The agreed likelihood and consequence categories determined for the environmental hazard are combined, using the following matrix, to qualitatively predict the environmental risk associated with each assessment area. Consequences Severe Moderate Minor


Likelihood

Low Medium Low Low Table 1‐6: Overall Environmental Risk

3.3 Firewater Runoff Risk

The agreed fire and environmental risk are then used to determine the overall site risk in terms of the requirement for firewater runoff risk assessment.


Consequences High Medium Low


Likelihood

Low Medium Low Low Table 1‐7: Risk Associated with Firewater Runoff

Where:

1. HIGH Firewater runoff containment will be required if further risk reduction measures are not implemented 2. MEDIUM Firewater runoff containment may not be required if further risk reduction measures are implemented 3. LOW Firewater runoff containment not required.

4.0 Fire Risk Assessment Results

Since 2007, the only significant change has been the introduction of the CCP (Combined Cooling and

Power Plant. This re‐assessment will essentially cover the fire risk associated with this facility and review

previous assessments.

The fire risk assessment was undertaken for each of 17 areas (Attachment 1). No additional fire water

detention measures were identified for the site.


Attachment No.1 Firewater Environmental Risk Assessments(117)

1. Production Area & Support Areas – Phase 1 (Lines 13‐19) & Phase 2 (19‐23)

Item Description

Activities

Contact lens manufacturing and support areas include corridors, offices, change rooms and lockers, goods lift, tool room, spare parts store, waste room, QC laboratory, cleaning stores, electrical room, raw materials staging & resin rooms

Materials

Final product , packaging, resins, monomer, aqueous salt solutions, production machinery, small quantities of solvent (<1 litre) stored in flameproof cabinet.

Fire Fighting

Automatic water sprinklers. Smoke detection and alarm systems, site occupied 24/7, emergency response teams, fire extinguishers throughout the area. Area enclosed by 2 hour fire resistant compartment walls.

Destination of Firewater

All fire water would go to process effluent drains located in the production areas.

Sprinkler Coverage Area (m2)

Phase 1 ‐ 4600m2 ; Phase 2 – 3600m2

Fire Risk (Likelihood X Consequence)

Low - Sources of ignition are confined to electrical equipment. Automatic sprinklers would extinguish most fires within a short period of time, and certainly minimise the risk of fire spread. 24/7 emergency response.

Overall Environmental Risk ((Likelihood X Consequence)

Low – materials used in the manufacture of lens and packaging, polystyrene and polypropylene resin and monomer (bunded container) are non‐dispersed and soluble in water and not hazardous to water (WGK=0). The remaining materials grease, lubricants, paper, ink, solvent are held in small quantities. Material quantities stored on site are limited. The total inventory of R52/WGK 1 material is signifjcantly less than 100t.

Additional fire retention required No

2. Production Area & Support Areas – 3GT (Lines 30‐37)

Item Description

Activities

Contact lens manufacturing and support areas include corridors, offices, change rooms and lockers, waste room, raw materials staging & resin rooms

Materials

Final product , packaging, resins, monomer, aqueous salt solutions, production machinery, IPA solvent (<50 litre). The total inventory of R52/WGK 1 material is signifjcantly less than 100t.

Fire Fighting

Automatic water sprinklers. Smoke detection and alarm systems, site occupied 24/7, emergency response teams, fire extinguishers throughout the area. Area enclosed by 2 hour fire resistant compartment walls. On fire/LEL or PEL alarm IPA supply is shut‐off.



Sprinkler Coverage Area (m2) 3600m2



Low - Sources of ignition are confined to electrical equipment. All ATEX rated equipment used with IPA, Automatic sprinklers would extinguish most fires within a short period of time, and certainly minimise the risk of fire spread. 24/7 emergency response.


Low – materials used in the manufacture of lens and packaging, polystyrene and polypropylene resin and monomer (bunded container) are non‐dispersed and soluble in water and not hazardous to water (WGK=0). The remaining materials grease, lubricants, paper, ink, solvent are held in small quantities. Material quantities stored on site are limited. IPA and PG has a WGK of 1 low hazard to water. The total inventory of R52/WGK 1 material is signifjcantly less than 100t.


3. Production Area & Support Areas – Phase 3 (Lines 24‐29) & Phase 4 (Lines 40‐45)

Item Description

Activities

Contact lens manufacturing and support areas include corridors, offices, change rooms and lockers, raw materials staging & resin rooms

Materials

Final product , packaging, resins, monomer, aqueous salt solutions, production machinery, small quantities of solvent (<1 litre) stored in flameproof cabinet.

Fire Fighting





8200m2




Low – materials used in the manufacture of lens and packaging, polystyrene and polypropylene resin and monomer (bunded container) are non‐dispersed and soluble in water and not hazardous to water (WGK=0). The remaining materials grease, lubricants, paper, ink, solvent are held in small quantities. Material quantities stored on site are limited. The total inventory of R52/WGK 1 material is signifjcantly less than 100t.



4. Materials Store and Distribution (Warehouse) Area

Item Description Activities

Storage of raw materials / products being delivered to/from the site.

Materials

Final product , packaging, resins, external bunded fire proof chemical store for oils and monomer.

Fire Fighting

Automatic water sprinklers. High level early suppression fast response (ESFR) sprinkler system. Smoke detection and alarm systems, site occupied 24/7, emergency response teams, fire extinguishers throughout the area. Area enclosed by 2 hour fire resistant compartment walls.




2400m2




Low – materials used in the manufacture of lens and packaging, polystyrene and polypropylene resin and monomer (bunded container) are non‐dispersed and soluble in water and not hazardous to water (WGK=0). The remaining materials grease, lubricants, paper, ink, solvent are held in small quantities. Material quantities stored on site are limited. Warehouse area (including chemistry & microbiology labs and facilities workshop) is separated from the service corridor and nearby waste plastic and boiler room by a 4 hour fire resisting compartment wall. Main warehouse area is separated from labs and facilities workshop by a 1 hour fire resisting compartment wall. There are 2 bund areas provided in the warehouse – 1) chemical lock‐up; 2) bund for temporary storage. The total inventory of R52/WGK 1 material is signifjcantly less than 100t.


5. PG External Storage Area

Item Description

Activities

Supply of Propylene Glycol to production areas in Phase 3GT & storage of PG within a dedicated bund area.

Materials

Propylene Glycol

Fire Fighting

Fire Extinguishers, Foam System (using Arctic foam – fire brigade only).emergency response teams, fire extinguishers throughout the area. Area enclosed by 2 hour fire resistant compartment walls.


The storage sheds and the yard area is bunded


N/A

Fire Risk Low - The material is not flammable and there are no sources of


(Likelihood X Consequence)

ignition in the area as the area had been designed originally for flammable material storage. 24/7 emergency response.


Low – PG is non‐toxic and not hazardous to water (WGK=0). The environmental load which could potentially cause damage to the receiving waters is low. PG is readily biodegradable and it is not classified as being dangerous to aquatic organisms.


6. IPA Tanker Loading & Bulk Storage Area

Item Description

Activities

Storage area for Iso‐Propyl Alcohol (IPA), before being pumped into main production plant for use in the manufacturing process.

Materials

Iso‐propyl alcohol

Fire Fighting

Foam System in place. The IPA facilities are 15 metres from the production building, which gives adequate distance in the case of a fire to consider this area as a separate fire zone. Area contains two bund storage units of 70m2 each.


Fire water retention pond


N/A


Medium ‐ IPA is stored in bulk liquid storage tanks in the Bulk Storage Area which is situated in the north west corner of the site. From the Bulk Storage tanks IPA is pumped into the main production plant for use in the process. Therefore as a result of the Hazardous Area Classification study undertaken at the site the IPA Tanker Loading and Bulk Storage Area has been identified as a hazardous area. Following from this equipment and work activities are controlled in this area to reduce the potential for ignition. On this basis the likelihood of a fire in the IPA Tanker Loading and Bulk Storage Area has been taken as medium. The suppression measures include a foam system in the IPA Tanker Loading and Bulk Storage Area. The IPA Tanker Loading and Bulk Storage Area is a fire zone providing fire containment. Explosion relief is also provided. However there is significant quantities of IPA stored in this area and, therefore, there is the potential for significant quantities of firewater run‐off to be generated if a fire occurred in this area.


Low – There is a low likelihood of environmental release as containment for spillages and accidental releases is provided, the tanker area is bunded and drainage is controlled by a TOC analyser to prevent accidental run‐off to storm drains. There would be a moderate environmental consequence as a result of a fire as a medium quantity of hazardous material would be released as the IPA would be retained in the fire water pond. Also the material would have a limited impact on the environment (IPA has a WGK of 1 – low hazard to water). The Mulkear is the receiving river and has a quality index of 4 which means it a good river quality status.

Additional fire retention required

Yes and provided as per Fire Water Risk Assessment PM Report

011644.22.040 ‐ November 2007


7. Combined Cooling Plant (CCP) Facility

Item Description

Activities

Two CCP engines produce 3MW of electricity for use within the plant. This provides for approx. 33% of the electrical load for the plant. There are 2 chillers provided and these provide 50% of the cooling load for the plant. 2 Electrical switch rooms.

Materials

Performax 3400; Biospherse 3001; Brewbrom TA; diluted in aqueous solution in separate enclosed bunded area. Not flammable or combustible.

Fire Fighting

Inergen Gas suppression system; gas supply slam shut on alarm, Fire Extinguisher.Smoke detection and alarm systems, site occupied 24/7, emergency response teams, fire extinguishers throughout the area.


Drains to process effluent drain and storm water in the area‐ oil interceptor provided.


N/A


Low – low potential for ignition. Automatic supression would extinguish most fires within a short period of time, and certainly minimise the risk of fire spread. 24/7 emergency response.


Low – materials used held in small quantities and diluted and stored in separate store external to gas engines.. Gaseous fire suppression system.


8. Waste Management Compound

Item Description

Activities

Storage of waste chemicals (small volume, bulk storage in separate area) and processing of waste cardboard/product waste.. There are two small chemical stores:

Materials

IPA Wipes and Rags; solvent waste (200L); monomers (400L); Waste Oil (1000L), Cardboard; Paper;. The total inventory of R51/WGK 1 material is signifjcantly less than 100t. All held in bunded areas. Compatible waste segregation arrangement.

Fire Fighting

Hydrants, fire brigade units if required (foam supplied on‐site); fire extinguishers. Fire Extinguisher. Smoke detection and alarm systems, site occupied 24/7, emergency response teams, fire extinguishers throughout the area.


Drains to process effluent drain and storm water in the area.


N/A


Low –waste management compound is outdoors, low potential for ignition


Low ‐ minimum quantities of chemicals in the area.



9. Laboratories (Chemistry & Microbiology)


General laboratory testing of products

Materials

Laboratory chemicals, small quantities of solvent (<2.5litre) stored in flameproof cabinet.

Fire Fighting



All fire water would go to process effluent drains


2250m2




Low – IPA wipes, ethanol, and acetone are all readily biodegradable and are not expected to significantly bioaccumulate. All, have low potential to have any toxic effect on aquatic organisms. Material quantities stored on site are limited.


10. Water Room and Utilities (Chillers, Compressors)

Item Description

Activities

Housing of water room and utilities, including 6 No. Chillers and 11 No. Compressors.

Materials

Water treatment chemicals (small quantities not flammable); electrical panels; motors.

Fire Fighting

Automatic water sprinklers. Smoke detection and alarm systems, site occupied 24/7, emergency response teams, fire extinguishers throughout the area. Area enclosed by fire resistant compartment walls. Area containment is as follows:

• Water room / boiler room – 3 hour fire resisting wall. • Water room / waste plastic – 1 hour fire resisting wall. • Water room / compressors & chillers – 1 hour fire resisting

wall. Water room / service corridor – 2 hour fire resisting wall.


All fire water would go to process effluent drains located in the areas.


Waste Plastics 1 ‐ 200m2 ; Waste Plastics 2 – 170m2 ; Waste Plastics 3 – 230m2



Overall Environmental Risk Low – all the chemicals in the area are used in water treatment, and


((Likelihood X Consequence) hence, they have very low levels of toxicity to receiving waters. Additional fire retention required No

11. Waste plastics (1, 2 & 3)


3 waste plastics rooms – manage the waste plastic from the production lines.

Materials

Waste plastic

Fire Fighting

Automatic water sprinklers. Smoke detection and alarm systems, site occupied 24/7, emergency response teams, fire extinguishers throughout the area. Area enclosed by fire resistant compartment walls. Area containment is as follows: Waste Plastic (phase 1):

• Waste plastic / water room – 1 hour fire resisting wall. • Waste plastic / service corridor – 2 hour fire resisting wall.

Waste Plastic (phase 2): • Waste plastic / service corridor & electrical sub‐station – 2

hour fire resisting wall. Waste Plastic (phase 3/4):

• Waste plastic / service corridor & electrical sub‐station – 2 hour fire resisting wall.

Waste plastic / compressors room – 1 hour fire resisting wall. Destination of Firewater



8200m2




Low –


12. Administration / Kitchen / Canteen Area

Item Description

Activities

Reception area, security room, passenger lift, offices, conference rooms, training rooms, toilets, kitchen, canteen and kitchen.

Materials

Stationary; Paper; Cooking oil in canteen; Cardboard; Chemicals.

Fire Fighting

Fire extinguishers, fire blankets and sprinklers. Smoke detection and alarm system throughout the area, except for the kitchen where a heat detection system is in place. Extra fire fighting equipment in kitchen / canteen area:

• 2 x fire blankets; • 2 x Wet chemical;


• 2 x CO2. Kitchen & canteen – enclosed by a 1 hour fire resistant compartment wall. Office Area:

• Office area wall adjacent to the Production area – 1 hour fire resistant wall.

• Production area wall adjacent to office area – 2 hour fire resistant wall.


Administration Area – to trade effluent drains. Kitchen Area – feeds into fowl sewer; Dishwasher drains to a grease trap.


Sprinklers: • Canteen – 345m2; • Kitchen / stores area / washing up area – 155 m2 • Administration – 3600 m2




Low


13. Boiler Room

Item Description

Activities

The Boiler Room houses natural gas boilers, boiler water treatment and the emergency smoke purge generator ( to be used in a fire only if requested by fire brigade.

Materials

Diesel; Natural Gas

Fire Fighting

Automatic fire suppression over boilers. Fire Extinguishers. High Level Sprinklers. Heat detection and alarm system throughout the area. Gas detectors located over the burner of each boiler, on alarm gas supply to area is slammed shut. Area protected by four hour fire resistant compartment.




250 m2


Low ‐ due to the fire safety systems and control measures in place. There are high level sprinkles covering the entire Boiler room. There are numerous fire extinguishers throughout the area.


Low



14. External Utilities Area (Cooling Tower, Nitrogen Generation Compound, Natural Gas Skid)

Item Description

Activities

External utility areas include cooling towers, nitrogen generation compound

Materials

Nitrogen , Natural Gas

Fire Fighting

Fire Extinguishers. Cooling Tower – protected by high level sprinklers, activation of which activates an alarm at reception.


Process effluent and storm drains


N/A


Low ‐ due to the fire safety systems and control measures in place. There are numerous fire extinguishers throughout the area. The area is external to the main building & fire spread to another area is considered unlikely.


Low


15. 38kV / 10kV Transformer Compound


The 38kV ESB Substation is located in a fenced off compound to the north west corner of the site. Compound contains 2 transformers.

Materials

Mineral Oil 5000L

Fire Fighting

Fire Extinguishers. All equipment is rated for high voltage and switchgear is metal clad. Al cabling is bare copper


To storm water drains – oil interceptor provided, which has the capacity to retain a full inventory of transformer oil.


N/A


Low – the probability of a fire occurring is considered to be low. Each transformer has lightning arrestors. An automatic fire detection system is provided at the transformer. The transformer compound is located away from the main building and the spread if fire is unlikely.


Low – the insulating oils used in the transformer are mineral oils, and therefore, non‐toxic. There are no other chemicals used in the compound. The drains from the transformer flow to an interceptor and thence to the oil interceptor before flowing to the storm drain.



16. 10kV / 400V Transformer Compounds (x4) & Switch Stations


4 No. 10kV / 400V transformer compounds (2 outdoor & 2 indoors)

Materials

Mineral Oil (maximum of 3000 litres)

Fire Fighting

Fire Extinguishers. All equipment is rated for high voltage and switchgear is metal clad. All cabling is bare copper. Indoor transformers – sprinkler system, fire extinguishers and smoke detection.


To storm water drains – oil interceptor provided, which has the capacity to retain a full inventory of transformer oil.


180 m2 each


Low – the probability of a fire occurring is considered to be low. Each transformer has lightning arrestors. An automatic fire detection system is provided at the transformer.


Low – the insulating oils used in the transformer are mineral oils, and therefore, non‐toxic. There are no other chemicals used in the compound. The drains from the transformer flow to an interceptor and thence to the oil interceptor before flowing to the storm drain.


17. Sprinkler Tank (x2) & Pump House

Item Description

Activities

The sprinkler tanks (2 No.) house the water supply for the sprinkler system throughout the plant. Tank 1 – 385m3 of water. Tank 2 – 382m3 of water. The pump house contains a quantity of diesel.

Materials

Diesel; grease; water;

Fire Fighting

Sprinkler system; Foam supply (for fire brigade use only) – held in bund area. Smoke detection system in pump house.


To Storm Water Drains, but oil inceptors are in place to prevent any oil‐like material passing into the storm water drain system.


180 m2 each


Low ‐ due to the fire safety systems and control measures in place. The pump house is protected by high level sprinklers. There are fire extinguishers located in the pump house. Although the area is not continuously manned, a smoke detection and alarm system is in place which activates an alarm at reception.


Low –Diesel stored within bunded area. The drains from the transformer flow to an interceptor and thence to the oil interceptor before flowing to the storm drain.



Attachment No. 2 – 3D Emergency Map


AER Attachment No. 6: Summary of Emissions & Waste PRTR Data

| PRTR# : P0818 | Facility Name : Johnson & Johnson Vision Care (Ireland) Limited trading as Vistakon Ireland | Filename : P0818_2010.xls | Return Year : 2010 | 5032 31/03/2011 19:50

Guidance to completing the PRTR workbook

Version 1.1.11REFERENCE YEAR 2010

1. FACILITY IDENTIFICATION

Parent Company NameJohnson & Johnson Vision Care (Ireland) Limited trading as Vistakon Ireland

Facility NameJohnson & Johnson Vision Care (Ireland) Limited trading as Vistakon Ireland

PRTR Identification Number P0818Licence Number P0818-02

Waste or IPPC Classes of ActivityNo. class_name

12.2.1 ######################################################

Address 1 National Technology ParkAddress 2 PlasseyAddress 3 LimerickAddress 4

Country IrelandCoordinates of Location -8.53814 52.6720

River Basin District IEGBNISHNACE Code 3250

Main Economic Activity Manufacture of medical and dental instruments and suppliesAER Returns Contact Name Margaret Stokes

AER Returns Contact Email Address [email protected] Returns Contact Position Environment, Health & Safety Manager

AER Returns Contact Telephone Number 061 203141AER Returns Contact Mobile Phone Number 087 2663652

AER Returns Contact Fax Number 061 232141Production Volume 0.0

Production Volume UnitsNumber of Installations 1

Number of Operating Hours in Year 8760Number of Employees 670

User Feedback/CommentsWeb Address

2. PRTR CLASS ACTIVITIESActivity Number Activity Name

9(c)

Installations for surface treatment of substances,objects or products using organic solvents,in particular dressing,printing,coating,degreasing,waterproofing,sizing,painting,cleaning or impregnating

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

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

Schedule 2 of the regulations) ? Activity 8 Is the reduction scheme compliance route being

used ? Compliance route

AER Returns Workbook

Sheet : Releases to Air AER Returns Workbook 31/3/2011 17:14

4.1 RELEASES TO AIR Link to previous years emissions data | PRTR# : P0818 | Facility Name : Johnson & Johnson Vision Care (Ireland) Limited trading as Vistakon Ireland | Filename : P0818_2010.xls | Return Year : 2010 | 31/03/2011 19:508 10 18 18 26 27 6 7 6 6 6 6 10

SECTION A : SECTOR SPECIFIC PRTR POLLUTANTSPlease enter all quantities in this section in KGs

QUANTITY

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

F (Fugitive) KG/Year

0.0 0.0 0.0 0.0 0.002 Carbon monoxide (CO) M ALT ISO12039 & ISO10849 141.0 0.0 0.0 0.0 0.008 Nitrogen oxides (NOx/NO2) M ALT ISO12039 & ISO10849 1173.0 0.0 0.0 0.0 0.0

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

SECTION B : REMAINING PRTR POLLUTANTSPlease enter all quantities in this section in KGs

QUANTITY

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


SECTION C : REMAINING POLLUTANT EMISSIONS (As required in your Licence)Please enter all quantities in this section in KGs

QUANTITY

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

351 Total Organic Carbon (as C) M OTH CEN 13526 494.0 494.0 0.0 0.0* Select a row by double-clicking on the Pollutant Name (Column B) then click the delete button

Additional Data Requested from Landfill operators

Landfill: Johnson & Johnson Vision Care (Ireland) Limited trading as Vistakon Irelan

Please enter summary data on the quantities of methane flared and / or utilised

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

DescriptionFacility Total Capacity m3

per hourTotal estimated methane generation (as per sit

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

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

above) 0.0 N/A

POLLUTANT METHODMethod Used

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

Method Used

Method Used

RELEASES TO AIRPOLLUTANT METHOD

Method Used

POLLUTANT

RELEASES TO AIR

RELEASES TO AIRMETHOD

| PRTR# : P0818 | Facility Name : Johnson Johnson Vision Care (Ireland) Limited trading as Vistakon Ireland | Filename : P0818_2010.xls | Return Year : 2010 | Page 1 of 1

Sheet : Releases to Wastewater or Sewer AER Returns Workbook 31/3/2011 17:9

4.3 RELEASES TO WASTEWATER OR SEWER Link to previous years emissions data | PRTR# : P0818 | Facility Name : Johnson & Johnson Vision Care (Ireland) Limited trading a 31/03/2011 19:508 9 17 23 6 8 6 6 22

SECTION A : PRTR POLLUTANTSPlease enter all quantities in this section in KGs

QUANTITY

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

A (Accidental) KG/Year

F (Fugitive) KG/Year

0.0 0.0 0.0 0.0 0.0 0.013 Total phosphorus M OTH APHA Methodology 93.0 0.0 0.0 93.0 0.0 0.0


SECTION B : REMAINING POLLUTANT EMISSIONS (as required in your Licence)Please enter all quantities in this section in KGs

QUANTITY

Pollutant No. Name M/C/E Method Code Designation or Description Emission Point 1 T (Total) KG/Year A (Accidental) KG/Year F (Fugitive) KG/Year303 BOD M OTH APHA Methodology 189480.0 189480.0 0.0 0.0306 COD M OTH APHA Methodology 428144.0 428144.0 0.0 0.0240 Suspended Solids M OTH APHA Methodology 6813.0 6813.0 0.0 0.0308 Detergents (as MBAS) M OTH APHA Methodology 73.0 73.0 0.0 0.0314 Fats, Oils and Greases M OTH APHA Methodology 2068.0 2068.0 0.0 0.0363 Total Dissolved Solids M OTH APHA Methodology 873333.0 873333.0 0.0 0.0

0.0 0.0 0.0 0.0* Select a row by double-clicking on the Pollutant Name (Column B) then click the delete button

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

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

Method Used

Method Used

POLLUTANT METHOD

POLLUTANT METHOD

Link to previous years emissions data Page 1 of 1

Sheet : Treatment Transfers of Waste AER Returns Workbook 31/3/2011 17:9

5. ONSITE TREATMENT & OFFSITE TRANSFERS OF WASTE | PRTR# : P0818 | Facility Name : Johnson & Johnson Vision Care (Ireland) Limited trading as Vistakon Ireland | Filename : P0818_2010.xls | Return Year : 2010 | 31/03/2011 19:505 77 Please enter all quantities on this sheet in Tonnes 35

Quantity (Tonnes per

Year)

Haz Waste : Name and Licence/Permit No of Next

Destination Facility Non Haz Waste: Name and Licence/Permit No of

Recover/Disposer

Haz Waste : Address of Next Destination Facility

Non Haz Waste: Address of Recover/Disposer

Name and License / Permit No. and Address of Final Recoverer /

Disposer (HAZARDOUS WASTE ONLY)

Actual Address of Final Destination i.e. Final Recovery / Disposal Site (HAZARDOUS WASTE ONLY)

Transfer DestinationEuropean Waste

Code Hazardous Quantity T/Year Description of Waste

Waste Treatment Operation M/C/E Method Used

Location of Treatment Name and Licence / Permit No. of Recoverer / Disposer / Broker Address of Recoverer / Disposer / Broker Name and Address of Final Destination i.e. Final Recovery / Disposal Site (HAZARDOUS WASTE ONLY) Licence / Permit No. of Final Destination i.e. Final Recovery / Disposal Site (HAZARDOUS WASTE ONLY)

Within the Country 18 01 01 No 0.31 sharps (except 18 01 03) D10 C Weighed Onsite in IrelandSRCL Dublin (formerly ECO Safe),W0055-002

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

Within the Country 20 01 21 Yes 2.84fluorescent tubes and other mercury-containing waste R12 C Weighed Onsite in Ireland

Irish Lamp Recycling,WCP/DC/08/1115/01

Woodstock Industrial Estate,Kilkenny Road,Athy,Co. Kildare,Ireland

Irish Lamp Recycling,WCP/DC//08/1115/01,Athy,.,Kildare,.,Ireland .,.,.,.,Ireland

Irish Lamp Recycling,WCP/DC/08/1115/01

Woodstock Industrial Estate,Kilkenny Road,Athy,Co. Kildare,Ireland

To Other Countries 15 02 02 Yes 18.93

absorbents, filter materials (including oil filtersnot otherwise specified), wiping cloths, protective clothing contaminated by dangerous substances R12 C Weighed Abroad Veolia (AVR),W0050-02

Corin,Fermoy,Cork ,Co. Cork,Ireland

Sava ,A51-G00 508,Sava ,GMBH,Germany,Germany,Germany

Sava ,GMBH,Germany,Germany,Germany

To Other Countries 07 05 04 Yes 18.93other organic solvents, washing liquids and mother liquors R12 C Weighed Abroad Veolia (AVR),W0050-02


Sava ,A51-G00 508,Sava ,GMBH,Germany,Germany,Germany


Within the Country 16 06 01 Yes 0.0 lead batteries R12 C Weighed Onsite in IrelandRetrunbatt Ltd,WCP/DC/09/1192/01

Old Mill ,Industrial Estate,Kill,Co. Kildare,Ireland

Returnbatt,W0192/03,Kill,.,Kildare,.,Ireland Kill,.,Kildare,.,Ireland

Within the Country 16 06 05 No 0.0 other batteries and accumulators R12 C Weighed Onsite in IrelandRetrunbatt Ltd,WCP/DC/09/1192/01

Old Mill ,Industrial Estate,Kill,Co. Kildare,Ireland

Within the Country 13 01 10 Yes 6.13 mineral-based non-chlorinated hydraulic oils R12 C Weighed Onsite in IrelandAtlas Oil (ENVA Ireland),184-1

Atlas Oil (ENVA Ireland),Portlaoise,Co. Laois,Ireland,Ireland

Atlas Oil,184-1/WCP/DC/08/1116/01,Laois,Co. Laois,.,.,Ireland .,.,.,.,Ireland

Within the Country 13 01 09 Yes 6.13 mineral-based chlorinated hydraulic oils R12 C Weighed Onsite in IrelandAtlas Oil (ENVA Ireland),184-1

Atlas Oil (ENVA Ireland),Portlaoise,Co. Laois,Ireland,Ireland

Atlas Oil,184-1/WCP/DC/08/1116/01,Laois,Co. Laois,.,.,Ireland .,.,.,.,Ireland

To Other Countries 14 06 03 Yes 4339.19 other solvents and solvent mixtures R12 C Weighed Abroad SRM Sunderland,BV4673IM

SRM Sunderland,Weeland Road,Knottingly,West Yorkshire,United Kingdom

SRM Sunderland,BV4673IM,Weeland Road,Knottingly,West Yorkshire,WF.11 8 DZ,United Kingdom .,.,.,.,United Kingdom

To Other Countries 07 05 04 Yes 425.26other organic solvents, washing liquids and mother liquors R12 C Weighed Abroad SRM Sunderland,BV4673IM

SRM Sunderland,Weeland Road,Knottingly,West Yorkshire,United Kingdom

SRM Sunderland,BV4673IM,Weeland Road,Knottingly,West Yorkshire,WF.11 8 DZ,United Kingdom .,.,.,.,United Kingdom

To Other Countries 07 01 01 Yes 4.81 aqueous washing liquids and mother liquors R12 C Weighed Abroad Veolia (AVR),W0050-02Corin,Fermoy,Cork ,Co. Cork,Ireland

Sava ,A51-G00508,Sava ,GMBH,Germany,Germany,Germany


To Other Countries 07 05 03 Yes 4.81organic halogenated solvents, washing liquidsand mother liquors R12 C Weighed Abroad Veolia (AVR),W0050-02


Sava ,A51-G00508,Sava ,GMBH,Germany,Germany,Germany


Within the Country 20 03 01 No 453.64 mixed municipal waste D1 C Weighed Offsite in Ireland

Greenstar Landfill ( Connaught Residual Landfill Site),WO 178-01

Connaught Residual Landfill Site,Kilagh More ,kilconnel ,Ballinasloe Co. Galway,Ireland

Within the Country 20 03 01 No 453.64 mixed municipal waste D1 C Weighed Offsite in Ireland



Within the Country 20 01 39 No 453.64 plastics D1 C Weighed Offsite in Ireland



Method Used




Year)



Recover/Disposer










Method Used

Within the Country 20 01 36 No 4.3

discarded electrical and electronic equipment other than those mentioned in 20 01 21, 20 01 23 and 20 01 35 R12 C Weighed Onsite in Ireland

KMK Metals Recycling Limited,W0113-03

Cappincur ,1E Daingean Road,Tullamore,Co. Offally,Ireland

Within the Country 20 01 01 No 327.3 paper and cardboard R12 C Weighed Onsite in Ireland Marwin ,IREG027/08

Marvin Environmental ,27 Carraig Aoil,Cloughduv,Co. Cork,Ireland

Within the Country 15 01 02 No 117.6 plastic packaging R12 C Weighed Onsite in Ireland Marwin ,IREG027/08


Within the Country 20 01 01 No 12.6 paper and cardboard R12 C Weighed Onsite in Ireland Marwin ,IREG027/08


0.0

Within the Country 15 01 02 No 3610.6 plastic packaging R12 C Weighed Onsite in Ireland Thorndale,WCP-LK-500-08b

77 Clooney Road,Campsie,London Derry,Northern Ireland,Ireland

Within the Country 20 01 08 No 4.0 biodegradable kitchen and canteen waste R12 C Weighed Offsite in IrelandMiltown Composting,WM-WP-28-03

Miltow More,Fethard,Tipperary,Co. Tipperary,Ireland





To Other Countries 20 01 39 No 16.0 plastics R12 C Weighed Abroad Schutz Uk,WML 43575

Claylands Avenue,Worksop,Nottinghamshire,S81 7BE,United Kingdom

Within the Country 20 01 01 No 133.5 paper and cardboard R12 C Weighed Offsite in Ireland Marwin ,IREG027/08


Within the Country 20 01 40 No 31.8 metals R12 C Weighed Offsite in Ireland Marwin ,IREG027/08


Within the Country 20 01 40 No 31.8 metals R12 C Weighed Onsite in Ireland Marwin ,IREG027/08


Within the Country 20 01 38 No 166.0 wood other than that mentioned in 20 01 37 R12 C Weighed Offsite in IrelandCF Sheeran,WCP-DC-09-1171

Shannon Street,Mounrath,Laois,Co. Laois,Ireland

Within the Country 20 01 40 No 57.8 metals R12 C Weighed Offsite in IrelandES Metals Ireland (formerly Hegartys Metals),WCP-05-04

Hegartys,Ballysimon Road,Ballysimon ,Limerick,Ireland

R12

Within the Country 15 01 02 No 83.2 plastic packaging R12 C Weighed Offsite in IrelandGreenstar,WCP/DC/08/1120/1

Sarcfield Court Industrial Estate,Glanmire,Cork,Co. Cork,Ireland

Within the Country 20 01 01 No 5.9 paper and cardboard R12 C Weighed Offsite in Ireland Rehab,WCP/DC/10/1257/01Rehab,Monahan Road,Co Cork,Cork,Ireland

Within the Country 20 01 25 No 4.8 edible oil and fat R12 C Weighed Offsite in Ireland Frylight,CP/LK/176/06c

278 Melmount Road,Victoria Bridge,Stabane,Co. Tyrone,Ireland

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




Year)



Recover/Disposer










Method Used

Link to previous years waste dataLink to previous years waste summary data & percentage change



AER Attachment No. 7: Decommissioning Management Plan & ELRA

Vistakon Ireland Ltd 011644-22-RP-0003 Issue B IPPC Licence Compliance 29 March 2011

011644-22-RP-0003_B_01.DOC Page 2 of 30

CONTENTS

1. EXECUTIVE SUMMARY 4

2. INTRODUCTION 6

2.1 Facility and Licence Details 6

2.2 Facility Closure Scenarios covered in this Plan 6

3. METHODOLOGY 8

3.1 Screening and Operational Risk Assessment 8

4. SITE EVALUATION 10

4.1 Facility Description and History 10

4.2 Facility Compliance Status 10

4.3 Facility Processes and Activities 11

4.4 Inventory of Site Buildings, Plant, Raw Materials and Wastes 12

5. CLOSURE CONSIDERATIONS 15

5.1 General 15

5.2 Clean or Non-Clean Closure Declaration 15

5.3 Plant or Equipment Decontamination Requirements 15

5.4 Plant Disposal or Recovery 15

5.5 Waste Disposal or Recovery 15

5.6 Soil Removal 15

6. IMPLEMENTATION OF DECOMMISSIONING MANAGEMENT PLAN 16

6.1 Production Areas 16

6.2 Utilities/Chemical Stores 16

6.3 Tank Farms 17

6.4 Cooling Towers 17

6.5 Fuel Tanks 17

6.6 Maintenance and Engineering 18

6.7 Offices, Administration, Reception 18

6.8 Laboratory Areas 18

6.9 Canteen and Kitchen 19

6.10 Warehouse 19

6.11 IPPC Licence Documentation 19

6.12 Other Areas 19

7. CRITERIA FOR SUCCESSFUL CLOSURE 21

8. CLOSURE PLAN COSTING 22


011644-22-RP-0003_B_01.DOC Page 3 of 30

8.1 Decommissioning Costs 22

8.2 Funding of DMP 26

9. CLOSURE PLAN UPDATE AND REVIEW 27

9.1 Proposed Frequency of Review 27

9.2 Proposed Scope of Review 27

10. CLOSURE PLAN IMPLEMENTATION 28

10.1 Statutory Authority Notifications 28

10.2 Full or Partial Closure Considerations 28

11. CLOSURE PLAN VALIDATION 29

11.1 Closure Validation Audit 29

11.2 Closure Validation Audit Report 30

ATTACHMENT 1 27 J&J Facility Decommissioning Guide 27


011644-22-RP-0003_B_01.DOC Page 4 of 30

1. EXECUTIVE SUMMARY

Vistakon Ireland Ltd develops, manufactures and distributes a range of soft, disposable contact lenses. The facility is located in the National Technology Park, Castletroy, Co. Limerick.

In 1994, Vistakon Ireland obtained planning permission for the construction of the first phase of the existing buildings, the manufacturing process and ancillary facilities. The second production block and ancillary services were installed in 1997-1998, along with ancillary support areas. The site infrastructure includes bulk storage and transfer facilities, thermal oxidiser/carbon absorber, combined cooling and power (CCP) system and firewater retention facilities.

Until 2007, the production of the disposable contact lenses included a water-based washing step. Vistakon has since converted some of the existing production to the manufacture of products using either Isopropyl Alcohol or propylene glycol (PG) in mixture with water. This is in addition to the existing de-ionised water process.

This Decommissioning Management Plan (DMP) was prepared in order to furnish the information required by Condition 10.2.1 of Vistakon’s Integrated Pollution Prevention Control (IPPC) Licence (Registration No. P0818-02), addressing the remediation, decommissioning, restoration and aftercare of the facility. This Decommissioning Management Plan is based on the Environmental Protection Agency’s (EPA) ‘Guidance on Environmental Liability Risk Assessment, Residuals Management Plans and Financial Provision’ (2006). This document has been prepared based on a complete review of the Closure, Restoration and Aftercare Management Plan (PM report 011644-22-RP-0003 Issue A), prepared for Vistakon in compliance with the previous IPPC licence (ref. P0818-01).

A review of the screening and operational risk assessment of the facility indicates that the facility lies in the high risk category (Category 3).

The scope of this plan addresses the key issues, which will occur in an orderly closure of all the site activities on a phased basis over an estimated time period of six months. The basis of the plan is to ensure that, upon completion of the plan, the facility would be in a suitable state for future industrial use and its condition would not pose a risk to public health and safety or to the environment. It is not intended to remove all structures or systems from the site. In general, specialist equipment will be distributed for re-use to other plants or sold off in the event of closure.

Vistakon intends to utilise existing staff resources to form a team to manage and execute the plan, supplemented where appropriate by external resources. This team would be responsible for managing and executing the complete plan. External contractors required for cleaning, waste disposal, incineration or recycling activities will be fully approved and licensed.

In the event of a spillage, leak or fire during decommissioning, Vistakon’s Emergency Response Plan would be fully implemented in order to minimise the risk to health and the environment.


011644-22-RP-0003_B_01.DOC Page 5 of 30

The costs associated with decommissioning are generally related to the disposal and recycling of equipment and the use of external resources to implement the Decommissioning Management Plan (DMP). In certain instances, costs will be recouped through the sale of equipment or materials or fixed assets.

It is estimated that a cost of approximately €475,800 (including 10% contingency) would be incurred to decommission the site, including external resource costs.

Vistakon confirms that the company has more than adequate resources from operations to fund the DMP. In addition, the value of the facility itself as a fixed asset worth in excess of €134m will far outweigh any remediation cost.


011644-22-RP-0003_B_01.DOC Page 6 of 30

2. INTRODUCTION

2.1 Facility and Licence Details

Vistakon develops, manufactures and distributes a range of soft, disposable

contact lenses, including the ACUVUE Disposal Contact Lens, the SUREVUE

Daily Wear Contact Lens and the 1-DAY ACUVUE TruEye disposable Contact Lens recommended for daily replacement.

The site was granted a review of its IPPC Licence in July, 2010 (ref. P0818-02). This Decommissioning Management Plan (DMP) has been prepared in order to furnish the information required by Condition 10.2.1 of the IPPC Licence.

“The licensee shall maintain a fully detailed and costed plan for the decommissioning or closure of the site or part thereof.”

This DMP is based on the EPA’s Guidance on Environmental Liability Risk Assessment, Residuals Management Plans and Financial Provision (2006). This document has been prepared based on a complete review of the Closure, Restoration and Aftercare Management Plan (PM report 011644-22-RP-0003 Issue A), prepared for Vistakon in compliance with the previous IPPC licence (ref. P0818-01). This DMP takes account of the new developments and operational changes on-site, which have taken place since the CRAMP document was issued in February 2008.

A review of the screening and operational risk assessment indicated that the facility lies in the high risk category.

2.2 Facility Closure Scenarios covered in this Plan

To develop a fully detailed and costed DMP, it is necessary to present a number of assumptions regarding the mode and management of a hypothetical site shut down.

Site closure is considered to include:

• Cessation of the IPPC licensed activity under Article 90 of EPA Act, 1992 as amended by the POE (Protection of the Environment) Act 2003;

• Voluntary or involuntary liquidation of the company or organisation holding the IPPC licence which results in the cessation of the activity;

• Transfer of ownership under Article 91 of EPA Act, 1992 as amended by the POE (Protection of the Environment) Act 2003;

• Site closure as a result of corporate rationalisation or relocation;

• Mothballing.

Vistakon Ireland is a subsidiary of Johnson & Johnson, a world-leading healthcare corporation. Vistakon is continuously expanding its state-of-the-art

manufacturing operation in Limerick, Ireland where it produces ACUVUE and other market-leading disposable contact lenses for the European and Asian market.


011644-22-RP-0003_B_01.DOC Page 7 of 30

The company operates a strict environmental policy. Therefore, it is firstly assumed that any shutdown of the site will be a well-planned and well-resourced event. This implies that the shutdown date will be known well in advance and that both production schedules and raw materials purchasing will be planned with the shutdown already factored in.

It is not intended to remove all structures or systems from the site. In general, specialist equipment will be distributed to sister plants or sold off in the event of closure.

Vistakon will have the resources in terms of both financial inputs and manpower to implement the DMP through to completion, with no requirement for external financing or manpower other than for expert advice. Vistakon intends to utilise existing staff resources to form a team to manage and execute the plan, supplemented where appropriate by outside resources. This Decommissioning Management Team would be responsible for managing and executing the complete plan. Outside contractors required for cleaning, waste disposal, incineration or recycling activities would be fully approved and licensed.

It is estimated that the duration of decommissioning and decontamination would be 3 to 6 months. Environmental monitoring would continue while the plan is in operation and for a period following the completion of the plan to be determined by the EPA and/or local authority. The EPA and the local authority would be informed of the results of the monitoring programme and the status of the plan. The objective of the plan is to ensure that, upon completion of the plan, the facility would be in a suitable state for future industrial use and its condition would not pose a risk to public health and safety or the environment.


011644-22-RP-0003_B_01.DOC Page 8 of 30

3. METHODOLOGY

The Environmental Protection Agency (EPA) issued ‘Guidance on Environmental Liability Risk Assessment, Residuals Management Plans and Financial Provision’ in 2006. The methodology incorporates three elements:

1. Closure, Restoration, Aftercare Management Plan (CRAMP), or Decommissioning Management Plan (DMP);

2. Environmental Liabilities Risk Assessment (ELRA); and

3. Financial Provisions (indemnity).

An Initial Screening and Operational Risk Assessment were performed on the facility to establish whether it was a low, medium or high risk facility. The findings of the initial screening and operational risk assessment are contained in the original CRAMP document completed in 2008 (PM document 011644-22-RP-0003 Issue A). For the purposes of this DMP, this screening and operational risk assessment has been fully updated and revised, taking account of new developments/process changes on-site. This review has been completed in compliance with Condition 10.2 of the IPPC licence.

Depending on the resulting classification, the EPA Guidance Document gives direction on how to complete the three elements.

3.1 Screening and Operational Risk Assessment

The review of the Screening and Operational Risk Assessment carried out established that the plant is a high risk facility (Category 3). The risk assessment is shown in Table 3.1 below.


011644-22-RP-0003_B_01.DOC Page 9 of 30

Table 3.1: Initial Screening and Operational Risk Assessment

Complexity1

Activity Band (G1-G5) Score

Class 12.2.1 G4 4

Environmental Sensitivity

Environmental Attribute Sub-Matrix Score

Score

Human Occupation: 50-250m2 3

GW Protection: Locally Important Aquifer

Vulnerability: High3

1

2

Sensitivity of receiving waters: Class A4 3

Air Quality and Topography: Simple terrain5 0

Protected ecological sites: <1km from site6 1

Sensitive agricultural receptors: >150m from site boundary

7

0

Total = 10

Environmental Sensitivity Classification Moderate 2

Compliance Record

Licensed facility with minor non-compliances 3

Overall Risk Score (Complexity x Environmental Sensitivity) x Compliance Record)

4x2x3 24

Risk Category Category

3

1 Based on IPPC and Waste Activities Complexity Look-Up Tables Vistakon falls into paragraph ‘12.2.1 The surface treatment

of substances, objects or products using organic solvents, in particular for dressing, printing, coating, degreasing, waterproofing, sizing, painting, cleaning or impregnating, with a consumption of more than 150kg per hour; resulting in Band G4

2 House to the south east beside Bohemian rugby grounds is between 50m and 250m from Vistakon.

3 Source GSI: http://spatial.dcenr.gov.ie/imf/imf.jsp?site=Groundwater. Locally Important Aquifer, Vulnerability = High to Low

(HL – only an interim study took place). Vulnerability score assumed High = 2

4 EPA River Quality Map for Ireland, the River Mulkear is classed as Q4, good status which is classed at A - Source EPA:

http://maps.epa.ie/InternetMapViewer/MapViewer.aspx.

5 Vistakon is situated on flat terrain

6 Vistakon is situated near a Special Area of Conservation (SAC). 002165, Lower Shannon River including the Mulkear River -

Source NPWS: http://www.designatednatureareas.ie/mapviewer/mapviewer.aspx.

7 There is no farming activity within 150m of Vistakon


011644-22-RP-0003_B_01.DOC Page 10 of 30

4. SITE EVALUATION

4.1 Facility Description and History

Vistakon develops, manufactures and distributes a range of soft, disposable contact lenses. Vistakon lenses are provided in compact cardboard multi-pack containers. Each lens is immersed in a sterilised, buffered, saline solution and enclosed in a separate polypropylene blister package that will maintain the lens in a sterile condition for up to five years.

Vistakon was founded in Buffalo, New York, U.S.A, in 1959 as Frontier Contact Lens Inc and relocated to Jacksonville Florida in 1962. In 1981, Johnson and Johnson acquired Frontier Contact Lens Inc and in June 1982, the name was changed to Vistakon.

Until 1994 all lenses were manufactured at the company's Headquarters in Jacksonville, Florida. Vistakon decided to locate in Ireland because of the favourable regime towards manufacturing investment and the availability of skilled labour. A major factor in their decision to locate in Limerick was the availability of a large greenfield site in a fully serviced high technology industrial park within easy travelling distance of Shannon Airport.

Vistakon Ireland's parent company, Johnson & Johnson, has many other manufacturing facilities throughout Ireland including; Alza/Cordis, DePuy, Janssen Pharmaceuticals and Janssen Biologics. With the exception of DePuy, these sites are also IPPC licensed.

Until 2007, the production of the disposable contact lenses included a water-based washing step. Vistakon converted some of the existing production to the manufacture of products which use Pharmacopoeia (high purity) grade Isopropyl Alcohol (IPA) or propylene glycol (PG) in mixture with water. This is in addition to the existing de-ionised water process.

The manufacture of current Vistakon products requires the use of IPA/PG as a cleaning agent in quantities that exceed thresholds set for a Class 12.2.1 Activity in the EPA Act 1992-2004 and hence the site is required to operate under an IPPC licence. A revised IPPC Licence (ref. P0818-02) was granted in July 2010.

The revised licence included for a Combined Cooling and Power facility and a geothermal cooling project.

4.2 Facility Compliance Status The site is generally compliant with its IPPC Licence conditions. Between 2007 and 2010, a small number of administrative/minor non-compliances were reported. These related to BOD and COD levels discharged to public sewer, above the limits permitted under IPPC licence P0818-01.

However increased discharge limits were previously agreed with Limerick County Council, pending approval by the EPA. These increased discharge limits were subsequently granted under licence P0818-02. Ongoing notification to the EPA regarding compliance with previous IPPC discharge limits was required until the new licence took effect in July 2010.

Other notifications to the EPA from 2007 to 2010 related to malfunctioning monitoring equipment. There have been no serious environmental incidents at the site, which may have caused significant pollutant release or potential


011644-22-RP-0003_B_01.DOC Page 11 of 30

damage to the environment. The site also operates an Environmental Management System (EMS), of which regular internal environmental audits are an element.

4.3 Facility Processes and Activities

Brief descriptions of the steps involved in the contact lens production process are provided below. It should be noted that the lens manufacturing machines are fully integrated and automated.

1. Injection Moulding

The injection moulding equipment makes lens moulds from amorphous thermoplastics and transfers the moulded parts to the Lens Fabrication Cell.

2. Lens Fabrication

Moulds are filled and the monomer is then cured. The cured lenses are demoulded.

3. Hydration

The lenses are hydrated as they move through the process where de-ionised water flows through the lenses. The production of the newest products requires the use of IPA or propylene glycol in mixture with water.

4. Primary Packaging

The primary packaging equipment receives raw material (hydrocarbon thermoplastic), moulds primary packages and transfers these parts for dosing with a lens followed by lens packing solution.

5. Post Hydration

The lenses are placed into the primary packages. The packages and lenses are then transferred through the automated inspection module. Defective lenses are rejected and good lenses are transferred to the heat seal unit. The sealed packages are then transferred to the Sterilizer Cell.

6. Sterilization

Products are steam sterilized. Once a valid sterilization cycle is completed, the lenses are removed from the sterilizer and transferred to the packaging area.

7. Cartoning

The Cartoning cell loads lenses into preformed cartons.

These process steps are supported by typical plant utilities including; water systems, boilers, compressed air, nitrogen gas and HVAC. In addition, the solvent-rich off-gases are vented to an abatement system. The abatement system comprises of a thermal oxidiser (TO) and carbon beds back-up system.


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4.4 Inventory of Site Buildings, Plant, Raw Materials and Wastes

Description of the Plant

The main production operations and supporting functions are conducted primarily inside the main production building. This building houses the following areas:

• Production (comprising Injection Moulding, Lens Fabrication, Hydration, Primary Packaging, Post Hydration, Sterilization, Cartoning)

• Administration and Laboratory

• Canteen

• Offices

Outside of the main building, on the site, are located:

• Existing Service Compound

• Combined Cooling & Power (CCP) plant

• Boiler chemical storage areas

• Cooling tower chemical store

• Sprinkler pumps (diesel driven)

• Warehouse chemical store

• Water room stores and water dosing area

• Transformers

• Contractor waste chemical stores

• Tanker offloading/loading area with full tanker containment

• Tank Farm

• Fire water retention pond

Parking for the site is located to the south of the site, in front of the administration area.

4.4.1 Stock Inventory, Raw Materials Information

The raw materials, packaging and finished product used in the production are stored in the Warehouse. The maximum quantity of material in these stores is 65T.

Non-hazardous waste materials are stored in designated waste receptacles in the yard prior to disposal.


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4.4.2 Hazardous Materials

Process solvents/reagents will be run down to minimum stock levels as part of the shutdown sequence. The small remaining amounts will be sent back to the supplier, which is the preferred method of disposal. If this is not possible, the materials will be sent for offsite disposal using an appropriate method as per the IPPC licence.

Current materials and maximum storage quantities are shown in Table 4.2.

Table 4.2: Process Material Storage On-site

Material Estimated Maximum Quantity

Storage Area (Tonnes)

Monomer 1 5

108 Staging

Monomer 2 1

Monomer 3 1

Monomer 4 1

Tween 1

Polymer 1 59

Polymer 3 20

Polymer 4 20

Isopropyl Alcohol 300 300 IPA Tank Farm

Propylene Glycol 17 17

2

PG Storage Compound

Methanol 0.01

3.5 Chemical

Store/Lock-up

Hydrocarbon Mineral Transformer Oil

0.05

Hydraulic 32 - Lubricating Oil

2.5

Hydraulic 46 oil 0.6

Gear Oil 0.1

Tri-solvent 0.25

Nitrogen 200 200 N2 Tank Farm

Acetone 0.005

0.65 Chemistry Lab Acetonitrile 0.025

Lab standard 0.6

AZO Wipes -

Diesel Fuel 1.36 1.36

Fire Pump House

Hydrochloric Acid

(Battery)/Water room

0.1

33.9 Water Room

2 Mass of propylene glycol (PG) estimated conservatively, assuming 100% concentration and density of PG equal to

1036kg/m3. It is noted that approx. 50% of PG stored on-site is 90% concentration with 10% water.


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Material Estimated Maximum Quantity

Storage Area (Tonnes)

Polyethylene glycol 0.001

Sodium Hydroxide 0.2

Amertrol BCL A

60SM

0.5

Sulfuric Acid 0.02

Sodium Chloride 22.6

Sodium Borate 0.15

Roclean 2 0.1

Diovasin Activ Hydrogen Peroxide

Acetic acid

Peracetic acid

0.06

Drewbrom TA 1

Drewgard (Performax) 2021A

1

R-134a 7

Performax 330 0.3

Sodium Hypochlorite

0.3

Amersite 0.5

Colorant 0.05 0.05 Colours Lab

Polymer 2

0.5 0.5 Production

Biosperse 3001 0.3

0.9 CCP Chemical

Store Drewbrom TA 0.3

Performax 3400 0.3


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5. CLOSURE CONSIDERATIONS

5.1 General Vistakon as a corporation does have a prescribed Decommissioning Guide to be adhered to in the event of planned or unplanned closure or divestiture of the site. A copy of this is provided in Attachment 1.

5.2 Clean or Non-Clean Closure Declaration Upon cessation of operations and subsequent decommissioning at the facility, it is anticipated that there will be no remaining environmental liabilities, i.e. clean closure is expected.

5.3 Plant or Equipment Decontamination Requirements All plant and equipment will be decontaminated to ensure the removal of any hazardous materials. Equipment will be verified either analytically or through a visual inspection, as appropriate.

5.4 Plant Disposal or Recovery Plant may be removed for use at other locations, left in place as part of the asset to be disposed of, or scrapped, based on risk assessment and cost benefit analysis.

Utility plant will be left with the asset, as mothballed equipment or ready-to–operate, depending on the best economic option.

5.5 Waste Disposal or Recovery All wastes, both non-hazardous and hazardous, will be sent for appropriate recycling, recovery, treatment or disposal, as per the conditions of the IPPC licence.

5.6 Soil Removal The facility is not obliged under its IPPC licence to conduct regular soil monitoring, as the processes conducted on site have little potential for the contamination of soil. Under Vistakon’s current IPPC licence annual monitoring of groundwater takes place and this will indicate if any contamination of soil has occurred or if testing is required.


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6. IMPLEMENTATION OF DECOMMISSIONING MANAGEMENT PLAN

Particular actions are listed below for specific areas of the facility as part of the DMP. In general, care and attention will be given during the implementation of the plan to ensure that the potential risks associated with the plan are avoided. In the event of a spillage, leak or fire during decommissioning, Vistakon’s Emergency Response Plan will be fully implemented in order to minimise the risk to health and the environment.

6.1 Production Areas The DMP for all production areas will consist of the following actions:

• Cessation of all production other than completion of work in progress.

• All products will be sent for suitable re-use, recovery, treatment or disposal. Any hazardous waste arising from the plant and utilities areas will be removed from site by an authorised haulier and disposed of to a suitably licensed facility.

• Cleaning and decontamination of all equipment which has had contact with hazardous materials. Existing site cleaning procedures would be sufficient for these operations. Additional specific procedures would be developed, if required. The state of cleanliness would be verified either analytically or through a visual inspection, as appropriate.

• Cleaning and decontamination of any ducting or enclosure that would have hazardous material contact.

• Shutting off unnecessary services to the building. Heating and ventilation capability would be maintained.

• Maintenance of key instrumentation and computer systems required for on-going monitoring of the status of the equipment; the remaining instrumentation to be disconnected and rendered safe.

• Cleaning and decontamination of all floor drains and sumps.

• All remaining specialised equipment will be sent for suitable re-use or sold to an interested party. Obsolete equipment will be recycled where possible or otherwise disposed of by a licensed contractor.

6.2 Utilities/Chemical Stores The DMP for the utilities areas would consist of shutting down the following systems on a phased basis, depending on plant status and requirements:

• Removal of any associated chemicals, oils or any other materials used in the utilities/staging area for redistribution, return to vendor or disposal, if required, according to best practice.

• The firewater pump house/water room including the water supply system would be maintained due to the needs for fire protection and sanitary services.


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• Waste oils, lubricants and diesel will be sent for suitable re-use, recovery, treatment or disposal as appropriate. Any hazardous waste arising from the plant and utilities areas will be removed from site by an authorised haulier and disposed of to a suitably licensed facility.

6.3 Tank Farms

• Running down any chemicals or material in the tanks

• Cleaning and decontamination of the tanks.

• All remaining chemicals will be sent for suitable re-use, recovery, treatment or disposal, as appropriate. Any hazardous waste arising from the plant and utilities areas will be removed from site by an authorised haulier and disposed of to a suitably licensed facility.

• The Thermal Oxidiser and Carbon Beds will be decommissioned in accordance with good engineering practice and the manufacturer’s recommendations.

6.4 Cooling Towers The DMP for the cooling towers would consist of the following actions:

• Cleaning and decontamination of the tanks;

• Any hazardous waste arising from the cooling towers area will be removed from site and disposed of to a suitably licensed facility

• Methods adopted will ensure any risk of contracting legionnaires disease is minimal;

• Dismantling of equipment and general cleaning and maintenance.

The site currently has the following cooling towers installed:

• 2 No. twin cell open circuit cooling tower: F1-EX-CT-1 & 2, F1-EX-CT-7 & 8;

• 2 No. open circuit cooling tower: F1-EX-CT-3, F1-EX-CT-4;

• 2 No. closed circuit cooling towers: F1-EX-CT5, F1-EX-CT6;

• 8 No. CCP dry air cooler: CCP3/1 thro CCP3/8;

• 1 No. dry air cooler: F1-EX-DAC1 (Emergency Back-Up).

6.5 Fuel Tanks The DMP for the fuel tank would consist of shutting down the following systems on a phased basis, depending on plant status and requirements:

• Removal of any associated materials used in the fuel tank area for redistribution, return to vendor or disposal, if required, according to best practice;


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• Waste oils, lubricants and diesel will be sent for suitable re-use, recovery, treatment or disposal. Any hazardous waste arising from the plant and utilities areas will be removed from site and disposed of by an authorised haulier to a suitably licensed facility;

• Dismantling of equipment and general cleaning and maintenance.

The site has 2 x 1000l tanks at the pumphouse that supply the generator that runs the water sprinkler system and 1 x 50l tank for the boilerhouse emergency generator.

6.6 Maintenance and Engineering

• All engineering documentation including drawings, process and instrumentation diagrams, validation documentation, vendor manuals and data, project files, maintenance records, inspection records and all other appropriate documentation will be securely archived.

• All remaining equipment will be disconnected to leave in a secure state. Equipment will be sent for suitable re-use or sold to an interested party. Obsolete equipment will be recycled where possible, otherwise disposed of by a licensed contractor.

6.7 Offices, Administration, Reception The DMP for the offices, administration areas, and reception would involve the removal of administration equipment for reuse or sale to interested party, where possible, otherwise for disposal by a licensed contractor.

6.8 Laboratory Areas The DMP for laboratory areas would consist of the following actions:

• Completion of all necessary analytical work on production in progress and all final products before removal from site.

• Return to vendor or sell on all unopened and in-date laboratory chemicals

• Removal of all opened chemical containers and out-of-date chemicals for recycling or for disposal by a licensed contractor.

• Cleaning and decontamination of laboratory instruments

• Cleaning and decontamination of all glassware, storage areas, waste systems and any other equipment or systems.

• Shutting down of all computer systems other than those deemed necessary for ongoing monitoring of the area.

• All remaining specialised equipment will be sent for suitable re-use or sold to an interested party. Obsolete equipment will be recycled where possible, otherwise disposed of by a licensed contractor.


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6.9 Canteen and Kitchen Canteen equipment would be removed for reuse or sale to an interested party, where possible, otherwise it would be disposed of by a licensed contractor.

6.10 Warehouse The DMP for the stores warehouse would consist of the following actions:

• Cancellation of all orders for incoming materials to the site;

• Negotiation with other plants with a view to distribution of unused materials;

• Negotiation with relevant suppliers to return unused materials to supplier;

• Dispatch of opened containers and non-returnable or out-of-date goods for appropriate treatment or disposal;

• Cleaning and decontamination of the storage areas.

6.11 IPPC Licence Documentation

All IPPC related documentation will be maintained on file at a designated location for a minimum of 7 years post closure of the facility. Where a transfer of the IPPC Licence takes place, the associated IPPC documentation will reside with the new Licensee.

6.12 Other Areas

The following other actions would be required to ensure the implementation of the DMP on a site-wide basis:

• Cessation of any construction project work on site so that the site is left in a safe and orderly condition. Contractors will be required to decommission any construction compounds and remove all construction equipment, construction materials and waste, storage units and temporary offices from the site at the completion of construction projects.

• Disbandment of contract personnel, facilities and equipment.

• Termination of all non-essential maintenance and other contracts.

• Removal from site any temporary offices or storage areas.

• Continuation of ongoing monitoring programmes to insure the integrity of the groundwater and surface waters on site.

• Rationalisation of the site electricity supply. This would involve removing transformers from service, allowing remaining site operations to run from one transformer. Oils would be removed from redundant transformers.

• Testing of soils and groundwater at the time of decommissioning would be performed and remediation carried out, if necessary. Groundwater wells on-site shall be capped and locked off.


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• Retention of all necessary fire alarms and fire protection systems.

• Retention of standard security patrols, CCTV monitoring and defined site access procedures.

• Removal of all items that may contain mercury (for example fluorescent lights) or any other controlled compounds for recycling or disposal if necessary.

• Decommissioning of underground sumps in the tanker loading and unloading bay / foul / process and drainage area with be emptied and cleaned following the completion of cleaning and decommission of the areas they serve. The drains and sumps will be surveyed. The sumps will then be filled with inert material (if not longer needed) and sealed to prevent unauthorized access. The silt traps will be cleaned out and the contents disposed of as per the IPPC licence.

• The contents of the petrol interceptors shall be emptied and disposed of by an authorised contractor to a suitable licensed facility.

• The boilers onsite will be decommissioned in accordance with good engineering practice and the manufacturer’s recommendations. It will be prepared for ‘dry storage’ or removal.


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7. CRITERIA FOR SUCCESSFUL CLOSURE

Successful clean closure will be expected to be achieved when it can be demonstrated through an Environmental Due Diligence Audit that there are no remaining environmental liabilities at the site. In practice this will require demonstration that the following criteria have been met:

• Continued compliance with IPPC requirements;

• All plant was safely decontaminated using standard procedures and authorised contractors;

• All wastes were handled, packaged, temporarily stored and disposed of or recovered in a manner which complies with regulatory requirements;

• All relevant records relating to waste and materials movement and transfer or disposal were managed and retained throughout the closure process;

• There was no soil or groundwater contamination at the site. This was verified using monitoring data and a soil/groundwater assessment at the time of closure (if required);

• The Environmental Management System remained in place and was actively implemented during the closure period;

• The asset is suitable for use as a commercial development site, as demonstrated by an environmental due diligence assessment.


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8. CLOSURE PLAN COSTING

8.1 Decommissioning Costs The costs associated with decommissioning are generally related to the disposal and recycling of equipment and the use of external resources to implement the DMP. In certain instances, costs will be recouped through the sale of equipment or materials.

It is expected that external resources will be required in order to implement the DMP in full. A list of these resources and associated costs is shown in Table 8.1 below. These costs were initially determined at 2008 unit prices for the purposes of the CRAMP issued previously. A 5% discount has been applied to unit prices, owing to deflation and increased market competition due to economic circumstances, resulting in lower costs.


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Table 8.1: Decommissioning Costs

Item Breakdown of Costs1 Estimated Cost (€)

Production Areas

Cleaning and Maintenance of all equipment 4 persons/4 weeks at €48/hr 30,720

Disposal of contaminated wash-water €1102/tonne (~75 tonnes)

3 8250*

Dismantling and transport costs in bringing to buyer 4 persons/4 weeks at €48/hr 30,720

Disposal cost of unsold equipment4 10T @ €190/T 1,900

Utilities Area

Cleaning and Maintenance 2 persons/2 weeks at €48/hr 7,680

Disposal of chemicals from store €110/tonne(~40 tonnes

chemicals run down 10%) 440*

Return of diesel to supplier 1 drum @ €24/drum 24

Tank Farm

Disposal/Treatment of all remaining chemicals €110/tonne (~10 tonnes

chemicals) 1,100*

Cleaning and Decontamination of the tanks 2 persons/2 weeks at €48/hr 7,680

1 Based on 40hr working week and cost rate per hour equal to €48 (average)

1 Based on decommission time of x persons / x weeks for area and an overall decommissioning time of 6 months for the site.

2 Figure subject to change depending on content of chemicals

3 Based on chemical in Staging and Production areas

4 Assumes minimum quantity


011644-22-RP-0003_B_01.DOC Page 24 of 30


Disposal of contaminated wash-water5 €110/tonne (~500 tonnes)

6 55,000

Cooling Towers

Cleaning and Decontamination of the cooling towers 2 persons/2 weeks at €48/hr 7,680

Dismantling of equipment and general cleaning and maintenance 2 persons/2 weeks at €48/hr 7,680

Fuel Tank

Disposal of all remaining chemicals €110/tonne (~1 tonnes) 110*

Dismantling of equipment and general cleaning and maintenance 2 persons/1 weeks at €48/hr 3,840

Environmental Monitoring of Site

IPPC Licence monitoring 6 months 4,750

Security

€38/hr (24/7for 6 months) 166,440

Laboratory

Dismantling of other equipment and general cleaning and maintenance 2 persons/2 weeks at €48/hr 7,680

Cleaning and Decontamination of the Laboratory/Instruments 2 persons/2 weeks at €48/hr 7,680

Removal of all opened chemical containers and out-of-date chemicals for recycling or for disposal by a licensed contractor

€110/tonne ~1 ton 110

5 Cleaning volume based on full fill of tanks

6 2 x 150m

3 IPA Storage Tanks + 200T N2 storage Tank


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Offices

Cleaning and Maintenance 2 persons/2 weeks at €48/hr 7,680

Warehouse

Cleaning and Decontamination of the storage area 2 persons/2 weeks at €48/hr 7,680

General waste

Disposal of general waste 10 T 7@ €190

8/T 1,900

Recycling of cardboard/packaging waste 25 T @ €190/T9 4,750

Other

Civil and structural, mechanical, electrical and instrumentation contractors 5 persons/4 weeks at €48/hr 38,400

Decommissioning of underground sumps 2 persons/3 weeks 7,600

Groundwater Testing 4 Boreholes x €335 1,340

Environmental Due Diligence Audit by professional consultancy 13,680

Subtotal 432,514

Contingency (10%) 43,251.40

Total €475,765

7 Based on estimate

8 Figure subject to change depending on content of material

* Based on 10% of total current storage volumes. Assumes stock allowed to run down to minimum levels


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It is estimated that a cost of approximately €475,800 would be incurred to decommission the site, including external resources costs.

The following assumptions were made in estimating the likely costs involved:

• The processes and operations at the facility do not give rise to any reasonable probability that site remediation in the form of groundwater or soil cleanup would be a likely requirement.

• The site would be left in a clean condition, i.e. decontaminated and certified as being free of any chemical hazard. All buildings would be retained. All raw materials, products, and hazardous materials would be removed.

• No liabilities would be incurred due to activities of contractors storing and disposing of materials removed from the Vistakon site, as Vistakon will continue to apply its current waste management principles.

• No civil liability would be incurred as a result of third parties alleging environmental damage arising from the operational phase or closure.

• Normal practice would be applied to minimise ongoing liabilities and to fulfil insurance requirements.

• It is assumed that the planning authority would not take any action to prevent site dereliction, as the existing facilities would be maintained in a condition suitable for future beneficial use. The planning authority will be notified of the plans to decommission and will be consulted in relation to the isolation of facilities and services on site.

• In addition, no factors have been identified that would indicate an unusual liability for the site in comparison with other process industry sites.

8.2 Funding of DMP Vistakon confirms that the company has more than adequate resources from operations to fund the DMP as set out above.

In addition, the value of the facility itself as a fixed asset worth in excess of €134m will far outweigh any remediation cost.


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9. CLOSURE PLAN UPDATE AND REVIEW

9.1 Proposed Frequency of Review The DMP will be reviewed annually and submitted to the EPA as part of the site’s Annual Environmental Report.

9.2 Proposed Scope of Review The scope of the annual review of the DMP will cover the following at a minimum:

• Review compliance with the facility’s IPPC Licence conditions;

• Review any incidents that may result in soil contamination;

• Review changes on site including processes and associated ancillary developments.


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10. CLOSURE PLAN IMPLEMENTATION

10.1 Statutory Authority Notifications The EPA and local authority will be notified of Vistakon’s intentions to fully or partially decommission the facility. In addition, local stakeholders including Shannon Development and the IDA will also be notified.

10.2 Full or Partial Closure Considerations Any partial closure of the facility will be dealt with as a change of activity, as long as the licensable activity remains on the site.


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11. CLOSURE PLAN VALIDATION

11.1 Closure Validation Audit Condition 10.4 of the IPPC licence requires that “A final validation report to include a certificate of completion for the Decommissioning Management Plan, for all or part of the site as necessary, shall be submitted to the Agency within three months of execution of the plan. The licensee shall carry out such tests, investigations or submit certification, as requested by the Agency, to confirm that there is no continuing risk to the environment.”

The scope of due diligence will be based on the size and complexity of the subject transaction, facility, and the property. The following measures will be taken into account when executing the due diligence audit:

• An environmental consulting firm will be retained to conduct the due diligence audit under the direction of Vistakon.

• The due diligence audit will follow a phased approach, designed to provide more in-depth information with each successive phase.

• Ample time will be allowed to complete all phases, including any required fieldwork and associated analytical testing.

• Where required, the scope of environmental assessments will comply with applicable standards, such as the ASTM Standard Practice for Environmental Assessments: Phase 1 Environmental Site Assessment Process.

A due diligence report will be prepared which shall include a summary and a detailed explanation of issues, grouped as follows:

• Environmental liabilities, past and present;

• Regulatory non-compliance issues along with a ranking of their severity and implications;

• Major environmental risks;

• Approximate cost estimate to bring closure to these issues.

Such an environmental due diligence audit would take approximately 8 weeks to execute and would cost in the region of €13,680. These costs included for soil and groundwater sample collection and analysis.

Divestitures and Exiting Leases

When divesting of facilities or real estate properties, an environmental assessment will be conducted to identify all environmental liabilities and establish a baseline report on the environmental conditions of the property at the time of transfer. These conditions should be documented and communicated to the purchaser representatives. A copy of the environmental assessment report will be submitted to Johnson & Johnson.

If environmental contamination is discovered, the decision to remediate conditions shall be agreed upon with the purchaser, in consultation with Johnson & Johnson and shall be reflected in the agreement of sale.


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If long-term (greater than two years) environmental warranty is given to purchaser, the scope of environmental assessment will be accordingly expanded to allow for the establishment of a much more comprehensive baseline. In these cases, at a minimum, sewer integrity testing should be added to the scope of the environmental assessment, unless testing had been recently completed.

11.2 Closure Validation Audit Report For an IPPC licence to be transferred or surrendered there must be a consultation process with the EPA. Normally, the EPA conducts a post-closure audit of the site and thereafter the EPA must be satisfied that the facility is fully compliant with its licence conditions at the time of closure in order to facilitate the formal surrender or transfer of a licence. Vistakon will implement any closure plan in consultation with the Agency, towards satisfying the authority that no residual risk(s) will remain.


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ATTACHMENT 1

J&J FACILITY DECOMMISSIONING GUIDE

Version 1.1 1 May 14, 2010

FACILITY DECOMMISSIONING GUIDE

Facility:

Address:

Site Contact: Phone:

Title: Fax:

Completed by: Date:

Reason for completion:

Version 1.1 2 May 14, 2010

INTRODUCTION

The Facility Decommissioning Guide is intended to assist the Decommissioning Project Manager in systematically assessing the numerous requirements to effectively and safely manage a facility closure. The guide is divided into several chapters and includes checklists with important criteria to consider when executing a closure project. Careful review should be taken to ensure that these facility closure considerations are evaluated and addressed appropriately. In addition, an understanding of national/local legislation and/or regulation will need to be defined. The Facility Decommissioning Guide includes six chapters. Each chapter addresses specific aspects of a decommissioning project that should be considered. It is important that the Decommissioning Project Manager create a file to include all records of evidence where documentation is required. Chapter 1: Facility Decommissioning - General This section contains general items that should be reviewed prior to completing the specific chapters. Chapter 2: Facility Decommissioning - Environmental This section addresses the environmental aspects of a decommissioning project. Chapter 3: Facility Decommissioning – Quality & Compliance Services This section addresses the quality & compliance aspects of a decommissioning project. Chapter 4: Facility Decommissioning - Health & Safety This section addresses the health & safety aspects of a decommissioning project. Chapter 5: Facility Decommissioning – Laboratories This section addresses the unique laboratory aspects of a decommissioning project. Chapter 6: Facility Decommissioning - Loss Prevention/Risk Management This section addresses the risk management of a decommissioning project and is divided into two sections:

1. During Facility Deactivation

2. Facility Closure Guidelines

Version 1.1 3 May 14, 2010

PURPOSE & SCOPE The purpose of this Facility Decommissioning Guideline is to describe the common requirements and activities that comprise the facility decommissioning process. The guideline checklists highlight the various discipline recommended actions necessary to carry out a successful decommissioning project. The final decommissioning report should include all documentation necessary to provide details of the steps taken to ensure proper closure of the facility. Each chapter will provide a list of recommended documents that should be included in the final report. The guideline is intended to assist in the closure of a facility but may be used for the transfer of facility activities. Initial commissioning of a new, or re-commissioning of a previously decommissioned facility, or entire facility demolition (limited demolition is included) is outside the scope of this guideline. If the facility is intended to be demolished, contact WW EHS, and/or your franchise EHS leader, for guidance.

HOW TO USE THIS GUIDE

The Facility Decommissioning Guide contains information for the project team responsible for the shut-down of a facility. Complete each chapter by answering each question, ensuring that any supporting documentation is transferred to the Decommissioning Project Manager. It should be noted that “Yes” answers to the questions in the checklists should drive a need for documentation in many cases, i.e. proof of completion. “No” responses to the questions in the checklists may include comments as to why it‟s not needed and a Decommissioning Action Item (DAI) may be developed to track closure. . In certain circumstances, decommissioning may include process safety management covered processes that require special attention, for example thermal oxidizers. In such cases, process safety management subject matter experts should be consulted prior to decommissioning such operations. If the decommissioning project includes selective demolition, particular attention should be given to items such as asbestos, local exhaust ventilation systems including dust collectors, chemical tank farms and process piping. In such cases, subject matter experts should be consulted prior to all demolition activities.

Criticality/Scale of the Decommissioning Project

Proper facility decommissioning is a critical step in the lifecycle of a facility. Just as we build facilities to be compliant with all J&J policies, governmental rules and regulations, the decommissioning process needs to do the same. It is important to follow these steps and answer the questions identified in this document to assure that the key aspects of all affected departments are met when decommissioning the facility.

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The effort required to decommission a facility should not be underestimated. There are many department personnel involved including Environmental, Health & Safety, Engineering, Risk Management, Quality, and others that must ensure the success of the overall decommissioning project. The effort needed will depend on the size and type of facility to be decommissioned. A small office building will require less effort than a laboratory or a pharmaceutical manufacturing facility. The level of effort should be commensurate with the level of risk that the decommissioning project creates for Johnson & Johnson.

RESPONSIBILITIES 1. Decommissioning Project Manager (DPM)

The Decommissioning Project Manager (DPM) has overall responsibility for the project and maintaining all documentation related to the closure project, including the following:

Ensure all project team members for the site are trained in this guideline.

Responsible for coordinating all decommissioning activities and ensure required inputs/

outputs and relevant communications are distributed to and/ or received from all parties

included in this guideline.

Ensure all documentation supporting the decommissioning effort conforms to the

requirements of local legislation, good documentation practices in general, and to all

other governing procedures, work instructions and quality practices specified in other

chapters of this guideline.

Ensure all work performed in the decommissioning effort by Facilities‟ contractors

conforms with: J&J WWEHS standards, local EHS regulations, proof of Insurance with

acceptable liability & coverage, etc.

Ensure the shutdown plan is aligned with the milestones and timetable of the larger

deactivation plan.

Report progress to management on key milestones until the facility is shut down.

Identify key personnel (i.e. Quality, EHS, Facilities, etc.) required to ensure the complete,

efficacious and compliant decommissioning of the facilities.

2. Decommissioning Project Team

The Decommissioning Project Team led by the Decommissioning Project Manager, should at a minimum have representation from Facilities, Risk Management, Engineering, Maintenance Environmental, Health & Safety, Legal, and site/area manager. Representation from Quality, Loss Prevention and Sterilization Process Technology should be selected if applicable based on project scope. The Decommissioning Project Team is responsible for collaborating on the planning, execution, verification and closure activities associated with the project. Depending on the project parameters, other individuals may also become members as the need arises.

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3. Subject Matter Experts

There are times during a decommissioning project where consultation is needed with subject matter experts prior to commencing the project, especially when limited demolition work is planned. The list below includes departments within Johnson & Johnson World Headquarters that include subject matter experts or can direct you to those experts who should be consulted when unique aspects of a decommissioning project arise.

• Engineering & Design • Quality Compliance Services • Risk Management • Sterile Process

Technology • Worldwide Environmental, Health & Safety

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DEFINITIONS & ACRONYMS

BOM - Bill of Material

CAD Drawings (Computer Aided Drafting) associated with a specific facilities system or

set of facilities systems that are maintained current and under revision control throughout

the associated system's life cycle.

CAR - Capital Appropriation Request

CE - Conformity Standard (European)

Commissioning (COM) - A well planned, documented, and managed engineering

approach to the startup and turn-over of a facility system to the Owner/ User that results

in a safe and functional environment that meets established design requirements and

documented expectations.

DAI - Decommissioning Action Items

Decommissioning - A well planned, documented, and managed engineering approach to

remove a facility system from use or qualified status.

DPM – Decommissioning Project Manager

Facility - Building and all the contents including utilities & process equipment

Facility System - An organization of engineering outputs that have a defined operational

function (e.g., buildings, utilities, mfg equipment, instrumentation, controls, etc.).

EHS – Environment, Health & Safety

HVAC - Heating, Venting and Air Conditioning

IQ - Installation Qualification

JSA - Job Safety Analysis

MSDS - Material Safety Data Sheets

NRC - Nuclear Regulatory Commission (United States)

OQ - Operational Qualification

Owner - An individual or department that has the responsibility for the operation and

maintenance of a system and bears the ultimate responsibility for compliance with

regulatory requirements for that system (typically Facilities Maintenance).

PPE - Personal Protection Equipment

PQ - Performance Qualification

SOP - Standard Operating Procedure

User - An individual or department that is the beneficiary of the services provided by a

system or interacts directly with a system; can be different from the owner. In the latter

case, the system user bears the ultimate responsibility for conformance to product/

process requirements for that system.

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CHAPTER 1

GENERAL

FACILITY DECOMMISSIONING – GENERAL CONSIDERATIONS 1. GENERAL:

Management appoints a Decommissioning Project Manager (DPM) to ensure that the decommissioning is done in compliance with all applicable rules, regulations, norms and standards.

The Decommissioning Project Manager is responsible for the implementation of the shutdown plan.

The DPM has developed a process for the transition, consulting with Johnson & Johnson Corporate resources as needed.

The DPM needs to be aware of the site‟s history, its operations, its high risk activities, and the high risk activities introduced by the decommissioning itself. This will complement and give context to the decommissioning action items.DAI

Plans have been made for the archiving of appropriate records (Quality, Environmental, Health and Safety and Employee Health). If operations will be transferred to another Johnson & Johnson facility, pertinent records need to be transferred to the receiving facility (such as standard operating procedures, emergency plans, Material Safety Data Sheets (MSDS), chemical inventory, waste characterization data, process flow diagrams, decommissioning documents, etc.).

The Project Team shall specify a person or organization that is responsible for the long-term, post-decommissioning management and retention of these records.

There is a communication plan in place to address inquiries from stakeholders and the community.

The impact on emergency response teams has been evaluated and action plans established to assure their ongoing effectiveness.

All pre-post transfer costs from above have been included in the move‟s capital appropriation request (CAR).

Each specific section in this document should be completed.

2. EQUIPMENT:

Determine whether equipment will be retained within Johnson & Johnson or sold. If equipment is to be sold or redeployed within Johnson & Johnson, the EquipNet Asset Redeployment Management System (ARMS) must be used. [refer to # 3 below]

In case of equipment transfer to other locations, a plan identifying functional

responsibilities and key personnel for handling the various aspects of the transfer

activities must be deployed.

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Ensure vital computer software (Building & Process Controls/Systems) critical to plant

functions and regulatory compliance has been maintained.

3. ASSET REDEPLOYMENT MANAGEMENT SYSTEM (ARMS) – A process for redeploying

assets, including internal redeployment and external sales.

When any piece of equipment is to be redeployed within J&J or sold externally via the EquipNet Asset Redeployment Management System (ARMS), a process must be followed in order to have the equipment eligible for redeployment or sale in the system. The first course of action will be to complete all of the questions which MUST be answered. Once the answers are submitted, an e-mail will be generated to the appropriate EHS professional to ensure review and sign off. After the EHS professional approves the form, the equipment can continue through the process for redeployment or sale. The ARMS system will track all approval flows via an electronic system that can be easily referenced and tracked to ensure the correct approval processes have taken place before equipment is redeployed or sold. It is important to note that equipment cannot be redeployed or sold externally until the appropriate EHS approval. After this initial step is completed, the equipment will continue through the redeployment process to be evaluated for legal, insurance and financial purposes before it is released for redeployment or sale. Click for link to EquipNet ARMS website

FACILITY EQUIPMENT/PROCESS: YES NO Comments Does the plan address requirements for transferring/shipping of a specific process, including transfer of related documentation (e.g., equipment manuals, maintenance/calibration documents)?

Before transferring, has the specific equipment/process been evaluated for compliance with current engineering codes, standards and practices (i.e., ASME, NEC, J&J Zero Access, etc.)?

For transferred processes, is the following information available: process and product hazard analysis risk, JSAs, SOPs and specifications, materials waste profiles and or analytical data (if any)?

Has an inventory of equipment for sale, transfer or scrap been developed?

Has an inventory of the assets on site of the decommission facility been created to ensure they are accounted for during the entire process. (Computers, AV equipment, LCD projects, etc.)

Has a consensus been reached with the receiving (for Johnson & Johnson locations) on upgrades (i.e., rewiring for new voltages, shipment to machine rebuilders, CE upgrading to comply with European regulations and local language requirements)?

For equipment planned for transfer - Has an equipment inspection visit been conducted to determine final equipment planned (including spare parts, guarding, manuals, etc) for Johnson & Johnson companies or outside purchasers?

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Has management agreement been obtained regarding decisions (price/acceptance) on all equipment dispositions (scrapping, relocation, or sale to competitive companies)?

Has the ARMS process been completed regarding the availability of equipment for locations inside and outside the company?

Has the ARMS process been followed regarding plans to disassemble, disconnect, scrap, and group equipment by recognized industry types? (Textile, material handling, shop tools, packaging, facilities equipment, liquids, tanks, and other appropriate groupings)?

Has an action plan been established to define roles and responsibilities, timetables, and scope relating to the transfer of equipment and work within the facility?

Are appropriate safe work rules and practices for contractors / internal personnel during disassembly operations established, enforced and confirmed?

Has an individual been assigned to gather, control and maintain confidential information on all computer equipment?

Has equipment been identified to match and mark critical parts, (e.g. Zero Access™ guards) for reassemble at final location?

Has equipment spare parts been collected to group them with equipment to be sold?

Has all equipment been appropriately packaged to ensure the safe storage, transportation, and arrival at the final destination?

If the equipment itself is subject to government registration, licensing, or permitting (e.g. lasers, RF), is there a plan to terminate the registration or license?

FACILITY - GENERAL: YES NO Comments

Have steps been taken for the shutdown and lockout of all non-vital functions including the following:

a) Maintain & periodically inspect all fire protection systems, equipment and operations e.g. fire extinguishers, fire watch, permits, hoses, and emergency gear during closedown?

b) Modify contracts for waste disposal, fuel delivery, water treatment chemicals and other production related services?

c) Adjust to meet the needs of changing activities within the facilities, (vending machines, cafeteria contracts termination, outside services as appropriate)?

d) Maintain vital subcontractor services (snow removal, grass cutting, landscape maintenance, reduced housekeeping etc), and reduce or terminate non-essential building related services?

e) Clean production residue in/on building systems/ structures to limit potential liability and safety related issues (toxic materials, silicone contamination, flammable materials, asbestos, tritium exit signs, mercury filled devices, heavy metal wastes etc.)?

f) Optimize energy management systems for none operational situation?

g) Winterize (or weatherproof) building-related non-operational functions?

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If there are any EHS issues that could expose Johnson & Johnson to third party liability, have all items been communicated to the Decommissioning Project Manager?

Does the plan include transfer of product, raw materials, chemicals, and work-in-process materials? Specifically, have any required hazard communications obligations, including MSDSs and labelling, been generated? Have the materials been properly classified, packaged, marked and labelled for transportation as per regulations by a regulatory qualified person?

Have waste chemicals, residual oils and other hazardous materials been properly disposed while maintaining required documentation?

Have company-related signs on exterior or interior facades been removed?

Does management plan to repair Building Code related deficiencies to pass inspection by local building code officials for future approval (electrical issues, plumbing issues, roof repairs, broken curbs, stack and vent removal, local re-roofing, signage, and health & safety issues relating to building occupancy- emergency exits)? If yes, are all action items added to the project DAI?

Are there plans to repair the facility for sale, remove extraneous foundations, fill concrete holes / trenches, remove excess conduit / wire-way ducts and add or relocate light fixtures appropriate with equipment removal? If yes, are all action items added to the project DAI?

Is there a plan to prepare the building for sale condition (painting plan, roofing repairs, re-lamping of fixtures, carpeting or tile replacement in worn areas, and parking lot repairs, etc.)? If yes, are all action items added to the project DAI?

If there are plans to lease back space from a facility buyer, are any risks present that need to be addressed.

If we are leasing space from the new buyer, has the purchasing company's EHS professional(s) performed a risk assessment of both areas providing a report with all EHS issues of concern?

Heating Ventilation and Air Conditioning (HVAC) Systems Was the HVAC unit used for general office space or pharmaceutical / laboratory processing / research areas? (To determine risk and how in depth the decontamination project would have to be.

Has an overall inspection of the system been conducted? Did the visual inspections of the system determine if humidifiers are part of the system? If yes, are these systems functioning as intended? (Note* Improper functioning humidifiers can lead to microbial growth and other indoor air quality issues.)

Is the ductwork a potential source of historical contamination from chemicals, biological, or radiological materials or fiberglass due to the materials of construction? If yes, consider testing to confirm contamination to determine whether the system needs to be cleaned, isolated, or removed.

Have visual inspections been conducted to ensure the HVAC units condensate drip pans function as intended and are free of any microbial growth due to standing water/moisture?

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If the HVAC units are to be removed, have the refrigerants been captured prior to the planned demolition work?

If the HVAC units are to be removed, have all of the connections to plant utilities been disconnected and all of the interconnecting piping and coils drained? If not, are proper lock out tag out procedures in place?

If the ductwork is to remain during any demolition work, have air intakes or returns been isolated to prevent contamination of the HVAC system and/or cross-contamination of other areas.

If the HVAC system is to remain during the decommissioning project but will eventually be removed, the system can be used as a means to provide negative pressure in the areas being demolished as long as the ductwork does not become contaminated from the demolition process.

Have all of the components in the ductwork system been disconnected from utilities (hot water, electrical, chilled water, steam, etc) ie reheat coils, humidifiers, VAV boxes, etc?

Has the ductwork insulation been tested for asbestos or other hazardous materials?

If the HVAC system is to be removed or partially removed: a. Is there a process or method developed to safely cut into and remove system components (piping, filters, collectors, etc.) along with protection for the contractors performing the work?

b. Does the historical use of the system allow for decontamination? c. Does the historical use of the system allow for recycling? d. Does the historical use of the system justify isolating the system components (e.g. capping the ends of the ductwork) and removing it as a classified waste?

e. For HVAC – Are there current drawings of the systems available with defined demolition boundaries, if not how will demolition be controlled?

Local Exhaust Ventilation (LEV) Systems & Pollution Control Devices

If the facility LEV system including fans, ductwork, and pollution abatement equipment (dust collector, thermal oxidizer, activated carbon bed, and scrubber) is to remain with the building, have these systems been cleaned to a predefined criterion?

a. Has this item been reviewed by the functional area responsible for the transfer of the property?

If the LEV system is to be removed or partially removed: a. Is there a process or method developed to safely cut into and remove system components (piping, filters, collectors, etc.) along with protection for the contractors performing the work?

b. Does the historical use of the system allow for decontamination? c. Does the historical use of the system allow for recycling? d. Does the historical use of the system justify isolating the system components (e.g. capping the ends of the ductwork) and removing it as a classified waste?

e. For LEV – Are there current drawings of the systems available with defined demolition boundaries, if not how will demolition be controlled?

MANAGEMENT: YES NO Comments

Will key safety services be maintained during phase-down and facility close-down for fire, first aid, security, winterizing equipment plans, and critical contracting services?

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Will key facilities maintenance equipment / people maintain the building to provide vital services during sale/transfer?

Are there firm dates to terminate appropriate operating and regulatory permits / contracts, (i.e., radiation licenses, waste disposal, sewer, environmental, gas, electric, water, supply contracts etc.)? If no, have all action items added to the project DAI?

Has the lead time to obtain government closure of permits, licensing, etc. been estimated or determined to understand the potential impact on the project timeline?

Has all vital information been archived on personnel issues/MSDS/health records, hazardous substance exposure monitoring data, chemical inventories, equipment operating instructions, equipment bill of materials, appropriate drawings, and building-related vital information, permits and operating instructions etc.? If no, have all action items added to the project DAI?

PRODUCTION PROCESS – GENERAL: YES NO Comments

Has the decommissioning plan included action items for the safe termination of production, return or scrap remaining raw materials), cleaning of storage tanks (confined space issues), cleaning of equipment, and shutdown and lockout of appropriate energy sources while maintaining essential building services?

Has the safe shipment of final production inventory, disposal of questionable products, return/transfer of remaining raw materials, and closedown relating to production assets been completed?

Is there critical Material Handling Equipment available to maintain a safe working environment and a final release date for the sale/transfer (i.e., maintenance of building high lift and heavy duty lift trucks?

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CHAPTER 2

ENVIRONMENTAL

FACILITY DEACTIVATION – ENVIRONMENTAL CONSIDERATIONS

There are two aspects that need to be considered in the deactivation of facilities:

A. Issues relating to the manufacturing facility that is closing and/or transferring manufacturing out.

B. Issues relating to the facility that will be receiving additional manufacturing.

This section addresses both aspects. It is intended as a tool to effect a smooth transition.

A. THE TRANSFERRING (CLOSING) FACILITY OR THE FACILITY THAT IS TRANSFERRING MANUFACTURING OUT

All environmental systems and procedures are to remain in effect throughout the closedown period until manufacturing ceases. The following issues need to be taken into account in these particular circumstances, in addition to the routine management of environmental affairs.

GENERAL: YES NO Comments

Is there a plan to ensure that, if tenured personnel are lost, all items pertaining to the environmental compliance of the facility (during and post-operations) will be transferred to an equally competent individual?

Has an assessment been conducted and documented to identify all EHS liabilities and establish a baseline report on the EHS conditions prior to transfer of the property?

The facility must identify any regulatory requirements relative to the closure of a facility and ensure that the assessment performed satisfies those obligations. The assessment is mandatory and should be performed in accordance with ASTM E1527 - 05 Standard Practice for Environmental Site Assessments: Phase I Environmental Site Assessment Process (or equivalent), with the additional elements required by the applicable authorities.

Has management ratified a corrective action or remedial action work plan to address any/all issues identified during the Phase I assessment, particularly any issues that are required to be resolved to achieve formal regulatory agency approval for closure? (The DPM is encouraged to seek WW EHS input for this process.)

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In the event corrective or remedial actions are projected to continue beyond the date that the facility is vacated, and/or beyond the date of property transfer outside of J&J, has a J&J EHS professional been identified to manage and drive the actions to closure?

In the event corrective or remedial actions will continue beyond the date that the facility is vacated, and/or beyond the date of property transfer outside of J&J, does the Finance department have a mechanism in place to provide appropriate financial reserve on an ongoing basis to fund the corrective/remedial actions required, up to and including obtaining any formal regulatory agency approval?

In the event corrective or remedial actions will continue beyond the date that the facility is vacated, and/or beyond the date of property transfer outside of J&J, has a member of the J&J Law Dept. been formally engaged to represent the interest of the Company in any real estate negotiations related to maintaining access to allow for remedial actions, sharing in costs if appropriate, and establishing any relevant indemnifications?

Has the minimum capability of the emergency response organization (staffing, equipment, materials) required to support both the safe and controlled decline in operations and the concurrent decommissioning activities been formally determined and vetted with management?

Have alternative (i.e., potentially external) arrangements for emergency response capability to support declining operations and ongoing decommissioning activities been identified?

If this risk will be addressed via a third party(ies), has an agreement been ratified such that, as soon as the minimum capability of the internal emergency response organization (staffing, equipment, materials) is not able to be reliably satisfied internally), the third party service will commence?

Has management considered establishing special/additional training sessions for temporary personnel (with no facility experience) that may need to be utilized to support the facility's normal operations during decommissioning (non-employees/standing contractors)?

Have all contractors providing decontamination, waste removal, and/or deconstruction/demolition support during the facility decommissioning received site and project task specific EHS training commensurate with their work during the facility decommissioning?

For those who have not, has a training needs assessment been performed and delivery system been developed?

For any equipment being transported to a) either a receiving facility or b) third party, which contain any regulated liquid or gaseous materials that might be released in transport, for example, mercury containing devices (switches, bulbs, thermostats), oil reservoirs, and/or gases (refrigerant, flammable, and/or toxic), are there plans to ensure those materials are properly removed and containerized at the facility prior to any transportation of the equipment?. (Any removed materials must also be disposed of properly, as is the case with all regulated wastes.)

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Has an inventory of all wastes (including non-regulated) to be generated pursuant to the decommissioning, including non-routine wastes (cement, roofing, textiles) and projected quantities, indicating disposal method and facility, been generated? Have all disposal facilities been confirmed as being capable and legally permitted to receive the intended wastes, and been confirmed to satisfy any applicable J&J TSDF approval process?

Are plans in place to maintain and archive all documentation related to disposal (agreements, audits, manifests/bills of lading, disposal instructions/restrictions, waste profiles/analytical data, weight tickets, confirmation of end fate (i.e., certificate of recycling, certificate of disposal)?

In the event of demolition, has a screening been performed for any/all potential environmental issues (for example, asbestos, silica, polychlorinated biphenyls (PCB) in caulk, deposited active materials, etc.) been identified or determined not to be present, and, if present, have proper containment, abatement, and disposal activities been arranged?

Are plans are in place for the final submission of environmental data to the regulatory agencies and WWEHS, such as waste volumes, energy use, water use, etc?

REGULATORY: YES NO Comments

Are plans in place to notify regulatory agencies to rescind permits and regulatory approvals when operations cease?

Has a list of all required formal documents/reports routinely (minimum 1/five years) submitted to regulatory agencies been generated?

Has someone been identified and a plan created to notify the party(ies) receiving these documents?

Have plans been formalized to inform these third parties that the facility is no longer subject to the requirement to report?

Does the plan include the timeline for mailing each report, based on the decommissioning timeline?

If there are environmentally related units that require obtaining a formal closure certificate from regulatory agencies (i.e., underground tanks, incinerators, and waste management units) are plans in place to submit the closure application well in advance of operation cessation to allow ample time for regulatory review?

B. THE RECEIVING FACILITY

GENERAL: YES NO Comments

Has management considered providing training to the facility‟s environmental professionals (by the transferring operations management) on aspects of environmental issues of the operations being transferred?

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Are there plans in place to obtain pertinent records from the transferring facility, (i.e., standard operating procedures, emergency plans, MSDS, chemical inventory, waste characterization data, process flow diagrams, etc.)?

(Each item requires its own response.) Is there a plan to carefully review environmental aspects of operations being transferred, such as water use, wastewater discharge, waste generation, chemicals use, air emissions, to ensure that:

a) Adequate storage facilities are in place for the safe storage of materials and chemicals?

b) Adequate waste disposal infrastructure is in place regionally to manage the waste generated from operations being transferred?

c) The facility‟s emergency response and preparedness/prevention are adequate for the additional operations and if not, that pertinent modifications are made to ensure their adequacy?

d) Adequate resources are in place to manage the environmental affairs of the operations being transferred?

e) Facility‟s emission control and discharge treatment system are in place or are adequate to handle the additional load?

f) Considerations are made to minimize environmental impacts of operations?

REGULATORY: YES NO COMMENTS

Are plans in place to review the aspects of operations being transferred to determine what new permits or modifications to existing ones are required to absorb the operations?

Are plans in place to review the aspects of operations being transferred to determine what additional regulatory requirements, approval, and reporting will result from the new operations?

Are plans in place to review the additional pollution load from the new operations to evaluate if there are limiting factors in obtaining the permits and/or authorizations from the regulatory agencies for handling the additional load (i.e., the local sewerage authority may have reached its capacity and cannot receive additional wastewater load)?

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CHAPTER 3

QUALITY & COMPLIANCE SERVICES

FACILITY DEACTIVATION – QUALITY CONSIDERATIONS

There are two categories of issues that should be considered in facility deactivation: A. Issues relating to the manufacturing facility that is closing and/or transferring manufacturing

out. B. Issues relating to the facility that will be transferring in/receiving additional manufacturing or

will be supplying new countries. This section addresses issues in both categories. It is intended as a tool to effect a smooth transition.

A. THE TRANSFERRING (CLOSING) FACILITY OR FACILITY THAT IS TRANSFERRING MANUFACTURING OUT

All existing quality systems, policies and procedures are to remain in operation throughout the closedown period until all manufacturing ceases, or until the particular processes in question are transferred out. The following issues need to be taken into account in these particular circumstances, in addition to the routine running of the quality system.

COMPLAINT HANDLING: YES NO Comments

Does a complaint handling system remains in place through the expiration date of the last product manufactured?

Has an adequately trained person been assigned the responsibility of complaint handling?

COMPONENTS/INVENTORY: YES NO Comments

Has the Decommissioning Project Manager assigned someone responsibility to transfer existing components/inventory? If Yes:

a) Are there documented provisions to protect components/materials from contamination or damage during transit?

b) Do the provisions include requirements for transferring related documentation (e.g. material/component specifications, LHRs)?

c) Do the provisions for special handling/environmental controls as required, during the transfer of components/inventory?

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EQUIPMENT: YES NO Comments

Has the Decommissioning Project Manager assigned someone responsibility for equipment transfer to another facility? If Yes:

a) Will the transfer of equipment address requirements for transferring/shipping including transfer of related documentation (e.g. equipment manuals, maintenance/calibration documents)?

FACILITY: YES NO Comments

Has the Decommissioning Project Manager assigned someone responsibility to oversee any space renovations, construction, electrical, utility or heating, ventilation & air conditioning (HVAC) modifications? If Yes:

a) Is there documented re-qualification activities for any product which will not be transferred?

b) Does the documentation include provisions for protecting components/products from adulteration or contamination?

c Does the documentation include provisions for performing validations of the facility changes or changes affecting other elements

of the master validation plan?

d) Is there a facility cleaning validation plan?

HANDLING, STORAGE, AND DISTRIBUTION: YES NO Comments

Have relevant procedures been documented related to handling, storage and distribution been reviewed and adapted in preparation for the transition to a marketing company?

MANAGEMENT RESPONSIBILITY: YES NO Comments

Has an in-depth quality risk assessment been performed and documented to identify potential issues of concern and their possible impact?

Is there a documented contingency quality plan in place to monitor and identify any possible, deliberate tampering or interference with product and processes, or deliberate attempts to compromise quality or compliance by dissatisfied employees?

Is there a documented contingency plan, or have adequate provisions been made should loss of key operations or of quality personnel, occur prior to close down or transfer?

Are there adequate resources to fulfil ongoing quality responsibilities as manufacturing continues, to monitor the closedown or to assist in the transfer?

Has the Decommissioning Project Manager assigned an adequately trained, sufficiently senior person to assume responsibility for the quality function once manufacturing ceases (e.g., manufacturing ceases but marketing continues)?

PERSONNEL: YES NO Comments

Has the Decommissioning Project Manager identified functional responsibilities and key personnel for handling the various aspects of the closedown or to transfer activities?

Has adequate training been provided to those staff responsible for closing down and/or transferring processes?

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Are there sufficient personnel to achieve the tasks required?

Has a written policy been established that addresses the use of temporary employees during the closedown period or transfer?

Does this written policy address where temporary employees may or may not be employed?

Has the regulatory impact of the use of temporary employees been taken into account?

Have limits been documented regarding the authority and/or decision making powers that may be delegated to temporary employees?

Are there provisions for the adequate training and documentation of such training for temporary employees?

PURCHASING: YES NO Comments

Have alternate suppliers (including JOHNSON & JOHNSON companies) been identified to replace product manufactured in-house?

Have detailed requirements been clearly communicated to the supplying company?

Are such companies able to supply product that will comply with requirements?

Will the supplying company be able to comply with regulatory requirements?

Is the formulation or the makeup of the product being acquired equivalent to that which had been manufactured locally?

Do proposed labelling and packaging comply with requirements?

Has the supplying company been informed of any requirements to notify companies receiving product of any product or packaging changes?

Are there any external manufacturers who will no longer be manufacturing for the company?

Is there a documented quality plan in place to handle the closing down of manufacturing at the external manufacturer?

Will any external manufacturers continue manufacturing for the company after internal manufacturing has closed down? If Yes:

a) Have adequate internal resources and personnel been allocated to monitor and maintain ongoing quality at the external manufacturer, as the quality function in the JOHNSON & JOHNSON company is scaled down?

Have any requirements or regulations been identified calling for the local testing of incoming product?

Have requirements for quality-related documents to accompany products been communicated to the supplying company?

Have proposed packaging and shipping containers from the supplying company been reviewed and evaluated for acceptability and performance?

QUALITY SYSTEM: YES NO Comments

Is the quality system being reviewed and redeveloped to take into account the transition?

Have existing CAPA‟s been reviewed and adapted to take into account the specific requirements of closing down/transferring out manufacturing?

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Has a documented action plan been prepared that incorporates quality considerations for the closedown and/or transfer of manufacturing?

Does a documented action plan include provisions made to maintain or increase the level of quality assessments during transition?

Is there a documented action plan to review and/or redevelop the quality system if the facility is not transferring all product lines & plans to continue manufacturing other product?

Is there a documented action plan to review the CAPA to ensure that system deficiencies will be corrected so that the same deficiencies will not be inherited by the receiving facility if processes are being transferred?

Is there a system for appropriate executive management review of complaints and stability results through the lifetime of the last product manufactured?

RECORDS: YES NO Comments

Has a documented review been carried out of all records to ascertain those which must be retained and those which need to be transferred to the supplying company, or company to whom any equipment/processes are being transferred?

Has a documented action plan been developed to include a provision for records that are to be retained and archived for at least two years, or for the life of the product, or according to regulatory requirements?

Have the documented action plan provisions been made for retrieval of records for possible inspection (especially electronic records)?

Has a documented action plan been established for the official removal and disposition of all documents from circulation (e.g.: specifications, test methods, batch records etc.)?


Is there a documented action plan to notify regulatory bodies of the facility changes and transfer of product?

Have appropriate regulatory bodies been notified?

Is there a timeline in place to ensure supply to market while submission for change of site is under review by the regulatory bodies?

Is there a system in place to update regulatory filings with stability results when required?

Is there a plan to notify environmental agencies?

RETAIN SAMPLES AND STABILITY STUDIES: YES NO Comments

Has a documented action plan been developed to include provisions made for the maintenance of an existing retains sample program?

Have documented action plans been made for continuing or transferring any stability studies that are ongoing In support of marketed product?

If product on stability study is to be transferred, have arrangements been made to transport this product under the correct environmental conditions?

Are all retains labelled in compliance with regulatory requirements (chemical name and hazard)? Have arrangements been made to ensure that relocation and/or storage activities are conducted safely and in compliance with regulatory requirements?

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B. THE RECEIVING FACILITY THAT WILL BE TRANSFERRING IN/RECEIVING ADDITIONAL

MANUFACTURING OR WILL BE SUPPLYING NEW COUNTRIES.

All existing quality systems, policies and procedures are to remain in operation throughout the closedown period until all manufacturing ceases, or until the particular processes in question are transferred out. The following issues need to be taken into account in these particular circumstances, in addition to the routine running of the quality system.

B.THE RECEIVING FACILITY

COMPONENTS/INVENTORY: YES NO Comments

Is there a documented action plan for receiving, inspecting, testing, identifying and segregating components/inventory being transferred from another facility?

Does the documented action plan include requirements for reviewing related documentation for completeness and adequacy (e.g. material/component specifications, LHRs)?

Are there documented provisions for special handling/environmental controls as required by components/inventory and/or by standards and testing procedures?

EQUIPMENT: YES NO Comments

Is there a documented Master Validation Plan for qualifying and validating equipment being transferred from another facility?

Is there a documented action plan to address equipment-cleaning validation?

Is there a documented action plan to address equipment calibration and maintenance?

Is there a documented action plan to verify receipt of related documentation from the transferring facility (e.g. equipment manuals, maintenance/calibration documents)?

FACILITY: YES NO Comments

Is there adequate space to transfer new equipment, product, inventory and personnel?

Is there a documented action plan to perform any space renovations, construction, electrical, utility or heating, ventilation & air conditioning (HVAC) modifications? If Yes:

a) Does the documented action plan include provisions for protecting components/products from adulteration or contamination?

b) Does the documented action plan include provisions for performing qualifications and validations of the facility changes or changes affecting other elements of the master validation plan for any products being manufactured before the transfer?

Is there a facility cleaning validation documented action plan?

Is there a documented action plan to address material flow changes?

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QUALITY SYSTEM: YES NO Comments

Is there a documented action plan to review and/or redevelop the quality system to ensure all required systems are in place to manufacture the transferred product?

Is there a documented action plan to review the CAPA to ensure that system deficiencies identified in the transferring facility are corrected so that the same deficiencies will not be inherited by the receiving facility?

Are there documented action plans to develop inspection, testing and audit programs to ensure the integrity and quality of the product being transferred into the facility?

Are there documented action plans to conduct product, process and test method validations?

Are there documented action plans for retain samples, stability testing and test method transfer?

PERSONNEL: YES NO Comments

Is there a documented action plan to identify functional responsibilities and key personnel for handling the various aspects of the transfer activities?

Has the Decommissioning Project Manager assigned an adequately trained, senior person been identified to assume management responsibility for the quality function?

Are there adequate resources and training for personnel in each functional discipline?

Has a written policy been established that addresses the use of temporary employees during the scale up period?

Has the written policy regarding temporary employees addressed the need for adequate documented training?

PURCHASING: YES NO Comments

Is there a documented action plan to notify existing suppliers of the transfer?

Is there a documented action plan to use new suppliers or external manufacturers? If Yes:

a) Is there a documented action plan to evaluate, assess, qualify and then monitor the quality of product to be supplied by new suppliers?

Is there a documented action plan to communicate detailed requirements to suppliers?

Has the inventory control system been updated to reflect changes in manufacturing (e.g. lead times, production schedules)?

RECORDS: YES NO Comments

Is there a documented action plan for storing and/or archiving quality and production records?

Is there a documented action plan to review all specifications and related quality and production documentation for adequacy and completeness prior to manufacturing?

Is there a documented action plan to address compatibility of systems and hardware used to store data electronically?

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Is there a documented action plan to notify regulatory bodies of the facility changes and transfer of product?

Is there a documented action plan to notify environmental agencies?

Are there plans to change components, materials or formulations? If Yes:

a) Are there documented action plans to conduct equivalency testing, compatibility testing, etc.?

Is there a documented action plan to assign responsibilities for complaint handling?

Is there a timeline for regulatory approval in each country where product will be marketed?

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CHAPTER 4

HEALTH & SAFETY

The H&S section checklist is intended to help identify hazards & programs that need to be evaluated and managed as appropriate during any decontamination/deactivation process. The H&S topics covered by this section includes: Hazard communication, emergency response, flammable liquids, general safety (confined space, LO/TO, welding, elevated heights), industrial hygiene, personal protective equipment, biosafety and decontamination procedures. For radiation, lead, asbestos and silica hazard, subject matter experts should be consulted. A general principal that should be followed prior to beginning any decontamination activities is to conduct very thorough baseline hazard and risk assessment to understand the scope of the work that needs to be completed. Based on the risk assessment conclusions, develop a project specific plan to manage all the activities until work is complete. If the team does have the appropriate subject matter expert, then ensure help, perhaps from corporate resources, should be requested. It‟s important to recognize that the attached checklist is not designed to address all scenarios but rather serve as a prompt for issues that need to be considered while develop and managing the task at hand.

Hazard Communications YES NO Comments Is there a hazard communications plan in place for both employees and contractors?

Is this plan incorporated into the contractor safety training program?

Has a review of historical processes, utilities and equipment to identify the hazards and risks from past or current operations in building(s) been identified and documented?

Do any identified hazards require any specialty training, authorization (including licensing or professional qualification), or equipment to be able to decontaminate and or remove? i.e. ( HAZMAT, Radioactive, Asbestos, Bio-hazards, lead etc.)

Is there a plan in place to assure appropriate warning signage is in place while specific tasks are being performed?

Are proper interim storage containers or areas in place before work starts, along with proper signage?

Have all required documentation of known hazards been made available to associates or contractors? (MSDSs, etc.)

Emergency Response YES NO Comments Are procedures or system in place to identify either internal or external local emergency responses to typical situations?

Are these procedures or systems part of employee and/or contractor safety training programs?

Are appropriate emergency response phone or contact numbers clearly posted for contractors to access?

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If emergency response is by internal associates, is proper equipment in place and easily accessed?

Have travel routes and emergency access to specific areas been considered for emergency responders?

Before dealing with specific hazardous tasks will/are emergency responders pre-warned of activities? (i.e. local fire departments)

Flammable Liquids YES NO Comments Have all flammable liquids to be removed been identified and located?

Are proper procedures in place to remove and appropriate disposal routes identified?

Have proper grounding and bonding procedures been developed?

Is remaining flammable liquids properly tagged, appropriate warning signage in place, and stored in a properly ventilated area?

Are there any liquids that require specialty training for handling or disposal?

Are proper interim storage containers or areas in place before decommissioning work starts, along with proper signage? (approved flammable liquid containers required?)

Confined Space YES NO Comments Have all known confined space areas been identified before decommissioning work begins?

Are proper procedures in place for working in confined space?

Is proper equipment and signage available for working in confined space? (i.e. retrieval equipment, air testing, communication devices, etc.)

Are these procedures or systems, and equipment part of employee and/or contractor safety training programs?

Lock Out Tag Out YES NO Comments Is there a LO/TO procedure in place for both employees and contractors?

Are these procedures or systems part of employee and/or contractor safety training programs?

Is there appropriate equipment and signage available for use to LO/TO? ( are suitable locks and tags on site or on location, includes locks for electrical and pressure systems)

For systems to be de-energized and locked out permanently is there a transfer process in place for the turnover or documenting of keys?

Have updated drawings and inventory of systems that will require LO/TO before work starts, been made available to the right personnel?

Have boundary of work drawings been made available to right personnel? i.e which systems will remain intact and which to be decommissioned?

Welding/Cutting YES NO Comments Is a process or procedure in place to control welding & cutting operations by using a hot works permit or other control system?

Is this part of the contractor training process?

Are appropriate system checks in place to tanks or piping that will be cut to assure cleaned or decontaminated?

Is there a list of required safety equipment to be on site and or in place before work starts? (extinguishers, signage, spark cloths, etc)

Is proper attaching of welding lead ground in place? (is clamp to building ground sufficient or specific local grounds required?)

Are there any local emergency responders that need to be notified of specific welding or cutting tasks?

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Elevated Heights YES NO Comments Does site have a current policy and or requirements for working at elevated heights (or fall protection)?

Is working at elevated heights part of the contractor safety training program?

Are all ladders, platforms, scaffolds, man-lifts, fall restraint, etc. used compliant with local legislation?

Is this equipment supplied by the contractor or site?

Is an inspection frequency in place to check any equipment being used on site?

Industrial Hygiene YES NO Comments Have we identified all the hazardous chemicals that may be present?

Do we have MSDSs for all these chemicals?

Do we have established OELs for all these chemicals?

Have we conducted a qualitative risk assessment for the activities that will be performed?

Is it necessary to conduct a quantitative risk assessment for inhalation and dermal hazards? If so:

Is there validated air and wipe sampling methods available?

Is there air and wipe sampling plan developed and reviewed by the project coordinator before the assessment is conducted?

Is the exposure controls (engineering, work practices and PPE) required based on the risk assessment results?

Has training on the proper use of the engineering controls been provided to all impacted employees and contractors?

Has a written strategy to conduct a post–decontamination „clearance‟ assessment been developed? Does the plan need to include air and/or wipe sampling?

Personal Protective Equipment (PPE) YES NO Comments Has appropriate (exposure level, compatibility, durability) personal protective equipment (gloves, coveralls, respirators, work boots, head protection, eye and face protection) requirements been identified to safely handle hazardous materials and are these requirements based on risk assessment results?

Are gloves selected for hand hazards present (chemical, puncture, laceration) hazards?

Have procedures been implemented to properly remove, collect and dispose of used PPE to minimize chemical contamination?

Are disposable coveralls required? If so, are they are compatible with the chemicals, equipment and activities being decommissioned?

If respirators are required, have they been selected based on results of chemical risk assessment, e.g. appropriate protection factors and chemical cartridges?

Has medical clearance provided for all workers utilizing respirators?

Have employees been provided appropriate facilities and training for gowning and de-gowning based on the PPE requirements including cleaning and disposal?

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Biosafety YES NO Comments

Were biological agents, toxins, and materials used at the site?

Have risk assessments been completed for decommissioning activities involving biological agents, toxins, research animals, and animal tissue materials?

Are biohazard labels applied to contaminated equipment, materials, and containers?

Are biosafety procedures and training requirements established for workers performing decontamination and decommissioning tasks inside BSL/ABSL spaces?

Are workers performing activities involving bio-hazardous and/or biological materials included in medical surveillance programs?

Are cleaning/disinfecting agents such as 10% bleach solution or Cidex specified for removing contaminants and contaminant residues from contaminated equipment, materials, and surfaces?

Are equipment cleaning and removal activities sequenced in a manner that will allow appropriate engineering controls (ventilation, waste containment systems) to remain in use until contaminated equipment, materials, and surfaces are containerized and/or decontaminated?

Are biohazard labels removed from equipment and material surfaces prior to its removal from the facility?

Decontamination and Work Zone YES NO Comments

For hazardous materials has a work zone or containment area been established to minimize exposures outside of containment area?

Are contaminated equipment, materials, and spaces designated for decontamination activities identified?

Will portable airlock, showers and change room be required to properly decontaminate people and equipment before exiting the containment zone?

Are agents and processes expected for use during decontamination activities determined to be effective in removing contaminants from contaminated equipment and material prior to its removal from the site? Can they be safely handled?

Are “clean” endpoint criteria identified for decontaminated equipment and material?

Where applicable, are the criteria defined by sample collection and laboratory analysis?

Are valid sampling and analytical methods developed for contaminants of concern?

Do assessments specify hazard mitigation and/or minimization methods to be used during decontamination activities, i.e., administrative controls, engineering controls; and personal protective equipment (PPE)?

Do decontamination procedures maximize the use of engineering controls for worker safety?

Are procedures implemented that identify equipment, material, and personnel traffic flow into and from contaminated or “hot” areas?

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Ergonomics YES NO Comments Has an Ergonomics Risk Assessment been completed for any proposed materials handling activities? (J&J preferred tool is the MHEJA : Manual Handling Ergonomics Job Analyser)

Have measures been implemented to reduce the risk of injury from manual materials handling activities to as low a level as reasonably practicable.

If transferring equipment to another J&J site has an appropriate Ergonomics Risk Assessment been passed to the EHS contact (consideration should be given to changes in anthropometric details of the new working population).

Special Consideration – Radiation, Asbestos, Lead, Silica, Steroids, Beta-Lactams

YES NO Comments

Have an assessment for the presence of radiation, lead, silica and/or asbestos been conducted? If so, have appropriate procedures and controls to safely manage these hazards been developed? Consult a subject matter expert to obtain technical input.

Will sensitive or regulated materials/equipment be transferred/stored to an intermediate location (neither the facility subject to decommissioning nor the destination facility)? If yes:,

a. Have adequate provisions for the security, safety, control, and inspection of these materials been established?

b. Have any/all regulatory registration and/or notification been identified and processed?

c. Has the interim facility‟s property insurer been contacted to ensure appropriate asset coverage is secured?

Were steroids or beta-lactams used in the facility planned for decommissioning? If yes:

a) What methods will be used to determine the level of contamination?

b) What is the desired target level below which is considered clean?

c) What method(s) will be used to ensure the area has been cleaned to a desired target level?

d) Is there a sampling plan to measure areas before/after cleaning? (e.g. aggressive air sampling)

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CHAPTER 5

LABORATORIES

The laboratory decommissioning section applies to all laboratory and auxiliary spaces serving as laboratories. The decommissioning process should be the same for these spaces as if decommissioning any other building or facility. Facilities with laboratories should also answer questions in the other chapters referenced in this guideline. The laboratory checklist can be used as a guide to eliminate and/or manage risks in laboratories when they are:

Vacated1,

Remodeled

Moved to another building,

Relocated to another laboratory area within the same building,

Decommissioned due to a change in laboratory function This checklist should be used in conjunction with Johnson & Johnson‟s Laboratory Decommissioning Guidelines and American National Standard Institute‟s (ANSI) Laboratory Decommissioning Standard (ANSI Z9.11-2008) or local legislation. The decommissioning process should, at a minimum, have a written plan that includes, but is not limited to a scope of work, risk assessment and characterization (historical, initial, etc.), decontamination and remediation, verification of decontamination and documentation.

LABORATORY QUESTIONS YES NO Comments Is there a written decommissioning plan defining the scope or work, risk assessment process, decontamination procedures, and final documentation deliverables?

Has risk assessment been conducted to characterize the existing facility conditions and hazards? This includes historical and current uses of the decommissioned areas and includes a historical document review, interviews of occupant and other knowledgeable individuals and inspection of the facility.

Has sampling been performed to determine if potential contaminants are present and to delineate the extent of contamination?

Has a review been conducted to document and manage chemicals (including active pharmaceutical ingredients) and biological materials used and stored in the laboratory? This includes chemical raw materials, working solutions, unknown materials including container integrity and labelling (chemical name & hazards), chemical reactivity, etc.?

If a perchloric acid fume hood was used, special precautions must be made prior to removing or dismantling the hood.

1 This includes laboratory operations at Johnson & Johnson owned properties, leased properties or spaces, or

external contract laboratory sites

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Was mercury or mercury containing devices (i.e. thermometers) used in the laboratory? If yes:

a. Were there any mercury spills or releases? Is a mercury vapor

survey needed to delineate the extent of any contamination?

Are all compressed gas cylinders removed from the area?

Were radioactive materials used in the laboratory? If so, answer questions a to l.

a) Has the Radiation Safety Officer, Health Physicist, qualified

radiation professional, consultant, etc. been notified?

b) Has a historical site assessment of the radioactive materials used

in the laboratory been conducted? This includes types of

radioactive materials, activities performed, areas of use, control

measures, etc.

c) Has radiation survey or sampling plan been developed to assess

levels and extent of contamination?

d) Has a release criteria been established to determined what

equipment or structures (floors, bench tops, hoods, etc.) need to

be decontaminated or disposed?

e) Is a Final Status Survey Report (FSSR) or similar document

required to be prepared and submitted to the governing authority

to document the radiological release criterions have been

satisfied?

f) Has the shipping and disposal of the radioactive waste been

coordinated with an appropriate licensed disposal company?

g) Is an amendment required to terminate or modify your radioactive

materials license? If so, has the appropriate paperwork been

submitted to the governing authority?

h) Is the radioactive material(s) being transferred to another

laboratory or facility? If so, laboratory listed on the material

license or does the receiving facility have the appropriate license

or permit?

i) Were any sealed sources (i.e. scanning gauges) or generally

licensed devices (i.e. liquid scintillation counters, tritium exit signs)

used?

j) Were all the personnel monitoring badges collected?

k) Have all the radioactive materials labels, placards, etc. been

removed?

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l) Has a final walk-through been conducted by the Radiation Safety

Officer, Health Physicist, qualified radiation safety professional,

consultants, etc. to review documentation and release the space

for unrestricted use?

Are any of the biological agents or stocks or hazardous chemicals being transferred or shipped to another location? If yes:,

a. Does the receiving facility have the appropriate license or

permits?

b. Does the person shipping the material have the appropriate

dangerous goods/IATA training

c. Is the material packaged in accordance with applicable

transportation specifications (i.e. IATA, DOT, etc.)

d. Are any special permits required to transport this material?

Are all the unwanted biological agents or stocks destroyed or deactivated? Note: Select agents or regulated agents may require the appropriate documentation?

Has the biological and chemical waste and contaminated consumables that cannot be decontaminated been segregated, labeled and packaged in accordance governing regulations?

Has the biological and chemical waste been removed from the laboratory and shipped with an approved and licensed disposal company?

Is an amendment required to terminate or modify the facility‟s permit or license to handle biological and/or regulated agents? If so, has the appropriate paperwork been submitted to the governing authority?

Have all the biological and chemical materials labels, placards, etc. been removed?

Has a final walk-through been conducted by the Biological Safety Officer, EH&S, consultants, etc. to ensure decontamination and removal of biological agents and hazardous waste, review documentation and release the space for unrestricted use?

Has a historical site assessment of the active pharmaceutical ingredients or pharmaceutical intermediate materials used in the laboratory been conducted? This includes the areas where these compounds were used and stored, activities performed, equipment used in conjunction with the compounds, control measures, and any known spills.

Is there a decommissioning scope of work that defines the acceptable decontamination process and release criteria (i.e. total removal, partial removal, encapsulate in place, etc.)?

Has EH&S performed a final review of the decontamination reports and conducted a final walk-thru of the space prior to releasing for unrestricted use?

Has the decontamination of work surfaces, storage areas, equipment and control measures with the appropriate disinfectant been performed and documented?

Has a release criteria been established to determined what equipment or structures (floors, bench tops, hoods, etc.) need to be decontaminated or disposed?

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Has the appropriate cleaning or disinfection solution been identified for the specific contaminant(s)?

Has the personal protective equipment required to decontaminate the structures, equipment, control devices (hoods, HEPA filters, etc.) been defined?

Has the decontamination waste generated been classified and disposed in the proper waste stream?

Has a final walk-through been conducted EH&S, consultants, etc. to ensure decontamination, removal waste, review documentation and release the space for unrestricted use?

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CHAPTER 6

LOSS PREVENTION/RISK MANAGEMENT This section contains two parts: A. Loss Prevention during facility decommissioning provides guidance on the issues to be

addressed before and during the deactivation of a facility. B. Facility Closure Guidelines covers issues to be addressed when a facility is closed.

A. LOSS PREVENTION DURING FACILITY DECOMMISSIONING

Facilities being decommissioned present a significant threat of property loss. A recent analysis of losses by FM Global over a 26 year period in these facilities indicated a total of 1,112 losses amounting to $393 million in total loss. Loss costs broken down by peril were: Fire – 48% Arson / vandalism / theft – 20% Weather related – 31% Other – 1% Contractor activities are a major source of destructive fires in industrial and commercial buildings. Decommissioning activities in particular are the cause of such fires. This is sometimes due to the lack of adequate guidance given to contractors. The term “decommissioning” applies to those activities necessary to prepare facilities in anticipation of selling the building, preparing the building or a portion thereof for a different type of manufacturing operation or demolishing the building. It is assumed that production stock has been removed but that utilities and piping systems are still activated when the contractors arrive at the plant. This document provides a checklist covering the planning and preparations to be taken before the contractor begins operations, precautions to be instituted during contractor activities, and the requirements to be followed to place the fire protection into a custodial status. This checklist covers the more common loss prevention issues that must be considered when decommissioning a facility. There are many types of equipment and systems that may be found in J&J plants that are not specifically covered in this checklist. There are resources available at J&J Risk Management and FM Global to provide specific advice. When informed of the decommissioning of a facility, FM Global will normally arrange for an engineer to visit the facilities to provide advice specific to the facility. The term “contractor” shall include Company employees engaged in similar activities on Company premises.

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The term “Decommissioning Coordinator” shall mean a qualified representative of the Company designated by JOHNSON & JOHNSON (J&J) to coordinate fire, safety and environmental matters and to oversee the enforcement of J&J standards and national regulations, whether explicitly written in the contract, or not.

Preparation for Decommissioning YES NO Comments Has a qualified employee been designated as the “Decommissioning Coordinator”?

Have additional employees been qualified to assist the Decommissioning Coordinator as Needed?

Has responsibility for building and equipment preparation and critical housekeeping functions been established before the arrival of contractors and the start of the decommissioning process (i.e. purging of pipelines, cleaning and waste removal, etc)?

Have Johnson & Johnson Risk Management and FM Global, the fire insurance company, been advised of the plans to decommission the facility and given the opportunity to provide advice regarding loss prevention?

Have all areas of the facility been designated as No Smoking areas?

If smoking areas are needed, are they located outside the facility and provided with proper receptacles for cigarette butts?

Have fire extinguishers, fire hose, shut-off valves, fire pumps, sprinkler systems and other emergency equipment been inspected and any needed testing, repairs, and replacements been completed prior to the start of decommissioning activities?

Have hot work and impairment procedures been reviewed and implemented and has a supply of hot work permits and impairment tags been obtained from FM Global?

Are safe cleaning methods being used for any equipment that may require cleaning prior to being removed from the site?

Has equipment for storage or transfer to other locations been moved to an isolated staging area (i.e. an onsite warehouse or decommissioned area of the property) and has proper security been provided to control access to this area?

Contractor Specifications YES NO Comments Have all contractors been instructed to work closely with the Decommissioning Coordinator throughout the project?

Have all contractors been instructed on all J&J rules regarding their work?

Does all equipment being used by contractors conform to J&J requirements?

Do J & J employees present at the facility have the ability to immediately shut down a portion of the work or the entire project, if any unsafe practices are being performed?

Are periodic meetings (at least once weekly) held to coordinate removal work, to assure fire-safe operations and continuity of fire protection at all times?

Are all contractors aware of J&J fire prevention rules?

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Are all contractors aware of their responsibility to prevent damage to the building and equipment (i.e. fire equipment, sprinkler piping, heating equipment, electrical equipment, etc.) during the course of their decommissioning activities?

Are contractors aware of the proper methods to disconnect utilities and equipment and is this work performed by qualified contractor employees?

Fire Protection Systems and Equipment YES NO Comments Is it planned that building sprinkler systems are to remain in operation at all times including prior to any deactivation work?

Before any portion of the building‟s fire protection is permanently impaired or terminated, has prior written approval of the Decommissioning Coordinator and J&J Risk Management been obtained?

Is the closing of any sprinkler system valves under the control of the Decommissioning Coordinator?

Is FM Global notified of all fire protection control valve closures?

Are impairment tags being used to assure that no system valve is inadvertently left closed and is FM Global notified when valves are reopened?

Before any transfer or removal of fire protection equipment, has prior written approval of the Decommissioning Coordinator and J&J Risk Management been obtained?

If plant air systems are planned to be shutdown, are alternate sources of air provided for fire protection systems such as dry pipe sprinkler systems?

During freezing weather, is sufficient heat maintained to prevent fire protection equipment from freezing?

During freezing weather, are large wall or roof openings properly closed to retain building heat?

Is the fire alarm system maintained in service at all times?

Is FM Global notified if work is being done on fire alarm systems?

Are only qualified contractors being used for work on fire protection systems and equipment and fire alarm systems?

Hot Work YES NO Comments Are alternatives to hot work utilized whenever possible?

Are all contractors familiar with the hot work procedures and use of the hot work permit system?

Are hot work permits used at all times except in areas specifically designated for hot work operations?

Is the area where hot work is done checked by the hot work permit issuer both before and after the work is completed?

Are trained fire-watchers provided during hot work operations?

Is sprinkler protection in service when hot work is being done?

Is a fire watch provided to periodically monitor the area when hot work is done?

Housekeeping YES NO Comments Is trash removed from each area before a contractor is permitted to begin work?

Is combustible trash and liquid waste removed promptly by the contractor as it is generated?

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Is combustible trash and liquid waste properly disposed of?

Is particular attention paid to areas where trash tends to accumulate?

Are residues, oil, lint and other combustibles removed as needed?

Are spilled oils and other flammable liquids properly and promptly cleaned up?

Flammable Liquids YES NO Comments Are alternatives to the use of flammable liquids used whenever possible?

If flammable liquids must be used, are less hazardous Class II and III materials used instead of Class I materials?

Are flammable liquids stored properly in a designated area?

Are approved safety containers used for transporting flammable liquids?

Are all safety containers returned to the designated flammable liquid storage area during off hours?

Are flammable liquid wastes collected in approved waste containers and properly disposed of?

Are oily rags or wiping waste placed in approved containers and properly disposed of?

Are proper cleaners used for floors, walls, windows, light fixtures etc. And not flammable liquids?

Are pipelines containing flammable or combustible liquids properly purged and flushed before any decommissioning activities are performed on the equipment?

Fuel / Compressed Gas Systems YES NO Comments When gas fired equipment is disconnected, is the gas supply shut off at the supply piping, disconnected and the opening plugged?

Are cylinder manifolds for compressed gases shut and the cylinders disconnected?

Are all compressed gas cylinders in the facility on an approved cart of vehicle and properly secured?

Is an approved area provided for the storage and replacement of empty and full cylinders?

Are all empty and full cylinders in this area properly secured?

Are qualified contractors used for decommissioning gaseous fuel and compressed gas systems?

B. FACILITY CLOSURE GUIDELINES

Whenever a plant is idle or vacated, proper safeguards against fire and other perils take on added importance. There may be less plant supervision, and operations such as de-activation, can increase the chances of a fire. The following represents general guidelines to reduce the chance of a loss occurring at an idle or vacant facility. Most of the loss prevention guidelines and requirements under Section A above for facilities being deactivated also apply to idle or vacated facilities. Some additional important guidelines and requirements are covered below.

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1. Definitions

A. Vacated Plant

The term “vacated plant” refers to a location where normal operations have been halted and will not be resumed. Most or all of the production equipment is removed from a vacated plant. Sprinkler systems, gravity tanks, fire pumps, and other protective equipment remain in service.

B. Idle Plant

An idle plant is a location where normal operations have been temporarily

interrupted. Both protective equipment and production facilities are maintained

serviceable.

Electric Power YES NO Comments Are lights maintained in service and emergency systems tested regularly?

Is power maintained in service for fire pumps, sump pumps, etc., and tested regularly?

For circuits that are not be in use, are the switches open (at main switchboard if possible)?

Are transformers shut down, except those providing needed power for essential equipment?

Flammable Liquids and Substances YES NO Comments Are flammable liquids and substances stored in portable containers removed from the site?

Except when needed for building heat, are discharge valves on butane or propane storage tanks closed?

Except when needed for building heat, are the pumps that supply fuel oil under pressure to plant distribution piping shutoff and the valves shut to isolate this equipment?

Are all in-service tanks monitored and checked for leakage?

Are all valves on gauge glasses closed?

Are all lines, tanks and other systems carrying flammable liquids or substances drained and purged or are at least valves closed to isolate this equipment to prevent release of contents?

Fire Protection Equipment YES NO Comments Unless all combustibles are removed and the building is totally of non-combustible construction, is sprinkler protection in service and sufficient heat provided to prevent sprinkler systems from freezing?

Have J&J Risk Management and FM Global been notified if any sprinkler systems are removed from service?

Is fire protection equipment inspected periodically to ensure that it is in proper working order?

Are all fire doors kept closed to reduce fire spread were a fire to occur?

Natural Gas, Flammable and Other Compressed Gases YES NO Comments Are main gas valves closed outside buildings or at the meters?

Are all burner valves closed?

Version 1.1 38 May 14, 2010

Are all compressed gas cylinders shutoff or disconnected at manifolds?

Is the number of portable cylinders inside buildings reduced to the minimum required for building needs?

Heating YES NO Comments Is sufficient heat maintained as needed for the buildings and to prevent water lines, plumbing fixtures, etc. from freezing or has this equipment been drained?

Housekeeping and Waste Disposal YES NO Comments Has all waste material from buildings and from the yard been removed and properly disposed of?

Has all lint or combustible deposits from machines, electric motors, switchgear, fixtures and the building structure been removed and properly disposed of?

Have all residues from equipment, hoods and ducts been removed and properly disposed of?

Has vegetation been trimmed as needed to maintain proper access to the facility and to fire protection equipment?

Maintenance of Protective Equipment YES NO Comments Is all fire protection equipment periodically inspected to make sure it is in proper working order and are any deficiencies found promptly repaired?

For an idle plant, is fire protection equipment maintained and tested?

For a vacated plant, is fire protection equipment maintained and tested if it is practicable to do so?

Notification of Shutdowns YES NO Comments Have J & J Risk Management and FM Global, the insurance carrier, been notified of plans to idle or vacate the facility?

Has the public fire department been notified of plans to idle or vacate the facility?

Plant Supervision YES NO Comments Is the plant alarm system and/or guard service being maintained at all times or has watchman service been provided/

Are hot work operations properly supervised with a written permit system used?

Are guards and any remaining plant employees kept aware of proper procedures to follow in case of an emergency?

Have public authorities (such as the fire department) been notified that the plant is shut down so they can respond properly in case of an emergency?

Security YES NO Comments Has an assessment been carried out to establish the level of security needed at an idle or vacated plant and the types of security systems that may need to be provided?

Are guards on each shift properly trained to operate security and fire alarm systems?

Is a remote monitoring system (such as a central station system) provided for fire alarm and security systems with the information being relayed to a central monitoring station?


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CONTENTS

1. EXECUTIVE SUMMARY 3

2. INTRODUCTION 5

2.1 Operational Changes since previous issue of ELRA 5

3. METHODOLOGY 6

4. DECOMMISSIONING MANAGEMENT PLAN 8

5. ENVIRONMENTAL LIABILITY RISK ASSESSMENT – UNKNOWN LIABILITIES11

5.1 Introduction 11

5.2 Assessment of Risks 17

5.3 Identification and Assessment of Mitigation Actions 20

5.4 Risk Management Programme 25

6. ASSESSMENT OF POTENTIAL ENVIRONMENTAL LIABILITIES 28

6.1 Types of Environmental Liabilities 28

6.2 ‘Unknown’ Environmental Liabilities – Current Status 28

6.3 Review of Risk Assessment 29

7. FINANCIAL PROVISION 30

7.1 Unknown Environmental Liabilities 30

APPENDIX A 31 Risk Assessment Table 31

APPENDIX B 35 Financial Model – Most Likely Scenario 35


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1. EXECUTIVE SUMMARY

Vistakon Ireland Ltd develops, manufactures and distributes a range of soft, disposable contact lenses. The facility is located in the National Technology Park, Castletroy, Co. Limerick.

In 1994, Vistakon Ireland obtained planning permission for the construction of the first phase of the existing buildings, the manufacturing process and ancillary facilities. The second production block and ancillary services were installed in 1997-1998, along with ancillary support areas. The site infrastructure includes bulk storage and transfer facilities, thermal oxidiser/carbon absorber, combined cooling and power (CCP) system and firewater retention facilities.

Until 2007, the production of the disposable contact lenses included a water-based washing step. Vistakon has since converted some of the existing production to the manufacture of products, using either Isopropyl Alcohol (IPA) or propylene glycol (PG) in mixture with water. This is in addition to the existing de-ionised water process.

The site was granted Integrated Pollution Prevention Control (IPPC) Licence Register Number P0818-01 by the EPA in August 2007. A Technical Amendment to the Licence was granted in December 2008 to cater for increased production and the resultant increase in wastewater volumes. The site was granted a review of its IPPC Licence (ref. P0818-02) to allow for the following developments on-site:

1. Installation of three number wells to abstract water from the aquifer below the site to be used as non-contact cooling water.

2. Use of propylene glycol (PG) in the hydration and washing stages of two production lines, replacing IPA in some processes

3. Installation of the Combined Cooling and Power (CCP) plant to minimise energy use

4. Increase in flow rate from emission point associated with Thermal Oxidiser (TO).

Condition 12.3.2 of the current IPPC Licence requires that:

“The licensee shall arrange for the completion, by an independent and appropriate qualified consultant, of a comprehensive and fully costed review of the Environmental Liabilities Risk Assessment (ELRA) to address the proposed changes on-site.

PM Group has been retained by Vistakon to carry out a review of the existing ELRA (011644-22-RP-0004 Issue Number A) in accordance with the requirement of Condition 12.3.2. The findings of this review are detailed in this report and this document comprises a complete update of the ELRA previously undertaken in August 2008. This Environmental Liabilities Risk Assessment (ELRA) is based on the EPA’s “Guidance on Environmental Liabilities, Risk Assessment, Residual Management Plans and Financial Provision” (2006).


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The Decommissioning Management Plan (DMP) (PM report number 011644-22-RP-0003 Issue B) addresses the remediation, decommissioning, restoration and aftercare of the facility (known liabilities). The cost of implementation of the DMP is estimated to be of the order of €475,800.

The existing mitigatory measures in place on the site are deemed adequate to manage the environmental risks satisfactorily.

Taking the most likely scenario costs and probability for each risk, costs are ascribed for remediation. The maximal cost determined for an unplanned environmental liability associated with the operational phase of the facility is €66,375 (including 20% contingency).

Vistakon confirms that the company has more than adequate resources from operations to fund the ELRA. In addition, the value of the facility itself as a fixed asset worth in excess of €134m will far outweigh any remediation cost.

The Environmental Liabilities Risk Assessment will be reviewed as necessary to reflect any significant change on site, and the financial provisions made to address unknown environmental liabilities will be reviewed and revised as necessary, at least annually, per Condition 12.3 of the licence.


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2. INTRODUCTION

Vistakon Ireland Ltd develops, manufactures and distributes a range of soft,

disposable contact lenses, including the ACUVUE Disposal Contact Lens, the

SUREVUE Daily Wear Contact Lens and the 1-DAY ACUVUE TruEye disposable Contact Lens recommended for daily replacement.

The site is licensed by the EPA under Integrated Pollution Prevention and Control (IPPC) Licence Register Number P0818-02, granted in August 2007. Condition 12.3.2 of this IPPC Licence requires that:

“The licensee shall arrange for the completion, by an independent and appropriate qualified consultant, of a comprehensive and fully costed review of the Environmental Liabilities Risk Assessment (ELRA), to address the proposed changes on-site. The assessment shall include those liabilities and costs identified in Condition 10 for execution of the DMP. A report on this review shall be submitted to the Agency for agreement within twelve months of date of grant of this licence. The ELRA shall be further reviewed as necessary to reflect any significant change on site, and in any case every three years following initial agreement. The results of the reviews shall be notified as part of the AER.”

PM Group (PM) was appointed by Vistakon Ireland Ltd to perform the review of the ELRA.

2.1 Operational Changes since previous issue of ELRA

The previous issue of the ELRA for Vistakon’s Limerick facility was completed in August 2008 (PM report number 011644-22-RP-0004 Issue A). Since this time, new developments and operational changes on-site affecting the ELRA may be summarised as follows:

A Technical Amendment to the previous IPPC Licence (ref. P0818-01) was granted in December 2008 to cater for increased production and the resultant increase in wastewater volumes. The site was subsequently granted a review of its IPPC Licence (ref. P0818-02) to allow for the following developments on-site:

1. Installation of three wells to abstract water from the aquifer below the site to be used as non-contact cooling water;

2. Use of propylene glycol (PG) (400l/day) in the hydration and washing stages of two production lines, replacing IPA in some processes;

3. Installation of a Combined Cooling and Power (CCP) plant to minimise energy use;

4. Increase in flow rate from the emission point associated with the Thermal Oxidiser (TO).

Otherwise there have been no significant developments or alterations to processes carried out on-site.


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3. METHODOLOGY

Environmental risk can be defined as the likelihood or expected frequency of a specified adverse environmental consequence. It expresses the likelihood of contamination arising from potentially polluting sources or activities (called the hazard). A hazard presents a risk when it is likely to affect something of value (the receptor). It is the combination of the probability of damage caused by the hazard occurring and its consequence that is the basis of a risk assessment.

Materials released from a source travels by means of a pathway to a receptor. Therefore, in assessing the hazard rating to the environment, the assessment must consider:

• The source – refers solely to the hazardous materials present on the site. Other site related factors are considered, for example management of the risk, the presence or absence of alarms or fail-safe devices, and the effectiveness of existing primary containment and any secondary containment which relate to the risk of release of hazardous materials.

• The pathway – the means by which any pollutant can escape to the environment. Pathways may be internal (i.e. within the boundaries of the site) or external; in the latter case pathways can extend for several kilometres or more.

• The receptor – the humans, animals, fish, plants and watercourses which would be affected (directly or indirectly) by the escape of the pollutants to the receiving environment.

Refer to Figure 3.1 for the source, pathway and receptor model. Identifying environmental risks with this approach requires a sufficient level of information on the characteristics of the environment around the site, with particular attention being paid to sensitive receptors such as designated areas, ecologically important and/or high quality habitats and protected species in the wider environment.

It is also necessary to understand the pathways by which uncontrolled releases from a site might enter and travel through the environment under a range of weather and seasonally-related conditions.

Figure 3.1: Source, Pathway, Receptor model

Source(e.g. oil or chemical tank)

Pathway (surface runoff

or through substrata) Receptor (e.g. lake,

sea, watercourse)

Receptor (groundwater)


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The methodology followed herein is that specified for detailed site-specific ELRAs in the EPA’s Guidance on Environmental Liability Risk Assessment, Residuals Management Plans and Financial Provision for Category 3 sites.

It comprises the following elements:

• Preparation of risk classification tables to evaluate and rank risks compared with one another;

• Identification and tabulation of the risks at the Vistakon site;

• Ranking of the identified risks to prioritise mitigation and management measures;

• Identification of planned mitigation measures and revision of risk scores subject to mitigation; and

• Quantification (costing) of the environmental liabilities associated with the identified risks.

The risk assessment process should be reviewed on a three years basis (as per Condition 12.3 of the IPPC licence) for relevance and accuracy.


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4. DECOMMISSIONING MANAGEMENT PLAN

A Decommissioning Management Plan (DMP) was prepared separately by PM in order to furnish the information required by Condition 10 of the IPPC Licence, addressing the remediation, decommissioning, restoration and aftercare of the facility. The DMP, PM report number 011644-22-RP-0003 Issue B, shall be submitted to the Agency with the Annual Environmental Report in March 2011. The DMP and ELRA are based on the EPA’s “Guidance on Environmental Liabilities, Risk Assessment, Residual Management Plans and Financial Provision” (2006).

An initial screening and operational risk assessment of the facility indicated that the facility lies in the high risk category (See Table 4.1 & 4.2). The risk assessment did not show any likelihood of significant residual liabilities.

Table 4.1: Risk Category

Risk Category Total Score

Low >5

Medium 5 – 23

High >23

The scoring index applied is detailed fully in the Guidance Documents. The following ratings have been applied to Vistakon:


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Table 4.2: Operational Risk Assessment

Complexity1 Score

Licenced Activity Class Band (G1-G5) Class 12.2.1

The surface treatment of substances, objects or products using organic solvents, in particular for cleaning with a consumption capacity of more than 150 kg per hour or more than 200 tonnes per year

G4 4

Environmental Sensitivity Sub-Matrix

Score Score

Human Occupation: 50-250m2 3

GW Protection: Locally Important Aquifer

Vulnerability: High-Low (HL)3

1

2

Sensitivity of receiving waters: Class A4 3

Air Quality and Topography: Simple terrain5 0

Protected ecological sites: <1km from site6 1

Sensitive agricultural receptors: >150m from site boundary

7

0

Total Environmental Sensitivity 10 2

Compliance Record

Licensed facility with minor non-compliances 3

OVERALL RISK SCORE (Complexity x Environmental Sensitivity) x Compliance Record)

4x2x3= 24

RISK CATEGORY Category 3

(High)

1 Based on IPPC and Waste Activities Complexity Look-Up Tables Vistakon falls into paragraph 12.2.1 The surface treatment

of substances, objects or products using organic solvents, in particular for dressing, printing, coating, degreasing, waterproofing, sizing, painting, cleaning or impregnating, with a consumption of more than 150kg per hour resulting in Band G4

2 House to the south east beside Bohemian rugby grounds is between 50m and 250m.

3 Source GSI: http://spatial.dcenr.gov.ie/imf/imf.jsp?site=Groundwater. Locally Important Aquifer, Vulnerability = High to Low

(HL – only an interim study took place). Vulnerability score assumed High = 2.

4 EPA River Quality Map for Ireland, the River Mulkear is classed as Q4, good status which is classed at A - Source EPA:

http://maps.epa.ie/InternetMapViewer/MapViewer.aspx.

5 Vistakon is situated on flat terrain.

6 Vistakon is situated near a Special Area of Conservation (SAC). 002165, Lower Shannon River - Source NPWS:

http://www.designatednatureareas.ie/mapviewer/mapviewer.aspx

7 There is no farming activity within 150m of Vistakon


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Site conditions and compliance have been evaluated and a plan for the implementation of successful clean closure drawn up, with associated cost estimates. The DMP assumes that the site will be brought to a state whereby the buildings may be sold on for re-use, i.e. they retain their value as a fixed asset.

Baseline groundwater quality at the site was assessed during the initial development of the site in 1993 and later in 1996. In general the groundwater at the site appears to be of good quality and further sampling undertaken in 2006 from boreholes GW1 (MW1) and GW2 (MW2) indicated no contamination of the aquifer in the area surrounding the Vistakon plant. All the parameters measured were stated as being within the limits set down in the EU Directive on the quality of surface water intended for the abstraction of drinking water with the exception of total and faecal coliforms. Elevated levels of these two parameters were detected in GW1 (MW1).

Following consultation with a hydrogeological consultant and a review of the drainage drawings for the site, it was determined that this contamination did not originate from a source at Vistakon. A land drain is located adjacent to the borehole, which takes run-off from an adjacent agricultural field. Coliform contamination can originate from farm animal waste products. There are no Vistakon foul sewer lines within 50m of the borehole.

A biannual programme of groundwater monitoring on-site was initiated in 2008, in compliance with the conditions of the IPPC licence in place at the time (ref. P0818-01). Groundwater monitoring was carried out at the site on four occasions during the 2008-2009 period, by independent groundwater consultants. The results of the monitoring programme for both 2008 and 2009 show no significant exceedance above the recommended guideline values, with the exception of chloride. Chloride levels were measured slightly in excess of the EPA Interim Guideline Value of 30mg/l. Further monitoring has been recommended to investigate the source of elevated chloride levels. The levels of chloride as measured to date do not indicate a pollution event at the Vistakon site nor do they constitute a non-compliance with the conditions of the IPPC licence.

The frequency of groundwater monitoring has been increased in 2010-2011, from biannual to quarterly, in compliance with Condition 6.15 of the revised IPPC licence (ref P0818-02) granted in July 2010. A professional assessment report on the results for groundwater monitoring shall be reported in the AER for 2010, to be submitted in March 2011.

Overall, the risk of any soil or groundwater contamination developing is considered low given the widespread use of secondary containment on-site and the operation of an extensive environmental management system. This indicates that there are no residual liabilities arising from past incidents/activities on the site.


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5. ENVIRONMENTAL LIABILITY RISK ASSESSMENT – UNKNOWN

LIABILITIES

5.1 Introduction

Environmental Liability Risk Assessment (ELRA) considers the risk of unplanned events occurring during the operation of a facility that could result in unknown liabilities materialising. As the initial risk assessment categorised the facility as a Category 3 facility (see Table 4.2), the site specific ELRA approach outlined in the EPA’s “Guidance on Environmental Liability Risk Assessment, Residuals Management Plans and Financial Provision” (2006) is required.

The potential for unknown liabilities to arise should be considered and financially provided for by way of ensuring that potential risks are covered by financial provision instruments.

The risks listed in Table 5.1 below were considered in relation to the facility.

In addition a firewater risk assessment (Report No. 011644-22-RP-0001) was completed as part of the IPPC licence application process. It was assessed that a 300m2 firewater retention pond was required at the Vistakon facility given the risk associated with any potentially contaminated firewaters from the IPA Tanker Storage and Unloading Area.

Furthermore Vistakon has in place an on site Emergency Response Plan which is designed to address unplanned events with potential risk to both the environment and human beings.


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Table 5.1: Unplanned Events that may result in Environmental Liability

Unplanned Event Comment

1.0

Fire at facility

Flammable solvents (IPA, propylene glycol) are used within the process at Vistakon Ireland Ltd.

The facility is provided with automatic fire detection and fire fighting systems. The CCP plant is provided with automatic fire suppression, controlled by heat detection.

Fixed fire fighting facilities, i.e. sprinklers and fire hoses are present on site at the Vistakon facility.

An automatic diverter valve is fitted to the surface water system. In the event of a fire alarm or a TOC exceedance, this valve will automatically divert all flow to the fire water retention system, which has a capacity of 300m

3. The firewater retention pond is

designed to protect the surface water system. Essentially this system is designed to take the volume of contaminated firewater that would overflow into the surface water system in the event of a fire, which would involve 60 minutes of fire water usage and tank failure of the largest tank in the bund.

This system, described in more detail in the Firewater Risk Assessment report (011644-22-RP-0001) submitted to and agreed with the EPA, ensures that contaminated firewater or chemical spillages are prevented from entering the River Mulkear and from contaminating surrounding land and hence groundwater.

All process wastewater is drained to the tank farm area and then to the process sump. The process wastewaters are directed to the process sewer normally or to the firewater system on activation of the fire alarms. In the event any bunds are contaminated the tank farm area sump pump out will have a manual option to direct the contaminated waste to the waste tanker loading arm.

Should there be a fire at the facility and the run-off is deemed hazardous subsequent to analysis, it will be disposed of as part of normal operating costs.

2.0

Leaks from above ground storage tanks

There are 6 no. aboveground storage tanks at the Vistakon facility.

All vessels and tanks containing hazardous materials are bunded according to the EPA volume requirements, i.e. 110% of the stored volume of the largest vessel in the bund.

In addition to the retention pond, chemical spill response materials, such as absorbent mats, are maintained on-site.

High level alarms are installed on solvent storage tanks to mitigate overfilling.

3.0

Leaks from underground storage tanks

There are no underground storage tanks at the Vistakon facility in the National Technology Park, Castletroy, Co Limerick.


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4.0

Spillages from bunds

All bunds are designed, tested and operated in accordance with the requirements of the EPA Guidance Note on the Storage and Transfer of Materials for Scheduled Activities.

5.0

Leaks from process and effluent drains

All pipe work used to carry foul and process effluent is designed appropriately according to use. Inspections as part of routine maintenance checks are conducted regularly which identify any leaks. Any leaks identified are repaired as soon as practicable.

6.0

Leaks/Rupture from underground/above ground pipes

Underground pipelines that carry process waste liquids are inspected by CCTV cameras at a minimum every three years.

The main above-ground pipes carrying liquids are those in the Process areas.

All pipe work used to carry foul and process effluent is designed appropriately according to use. Inspections as part of routine maintenance checks are conducted regularly which identify any leaks. All inspections include all flanges and joints. Any leaks identified are repaired as soon as practicable. Good design and installation of pipes was applied at the Vistakon site.

7.0

Overspill from fire water storage at facility

Firewater for hydrants and the sprinkler system is currently stored in two 400m3 firewater storages tank at the Vistakon facility.

These tanks are enclosed and there is no risk of overspill.

8.0

Any tank overflows

High level indicators in place on tanks make this scenario unlikely.

Nonetheless, any material overflowing from a tank will enter either local bunding/containment or the process effluent system, which drains to the WWTP.

9.0

Mobile tanker spills on site

The materials brought on or offsite in tankers are Isopropyl Alcohol (IPA) (70%), propylene glycol (PG) (90-100%) and diesel.

The delivery of this material by mobile tanker is covered in the site Standard Operating Procedure for Unloading of Bulk Chemicals. Surface water drains are protected against spillage when unloading is taking place by control valves. It is established site practice that Vistakon personnel must be present when loading/unloading occurs.


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10.0

Leak/rupture of a container during loading/unloading.

Chemicals are brought on site in bulk quantities. Unloading of Bulk Chemicals procedure covers these operations. Surface water drains are protected against spillage when unloading by control valves.

The storage, containment and handling facilities for all materials at the facility are designed in accordance with statutory requirements and best practice to minimise the likelihood of accidental leaks/spillages occurring and to contain any such leaks / spillages should they occur. There are dedicated tanker unloading areas surrounded by a drainage channel which drain to a sump designed to contain 110% volume of the tanker. All hazardous materials used on-site are stored in bunded areas or on spill pallets appropriate to the quantity of material stored.

Propylene glycol is pumped directly from IBC storage to the production line.

Preventative maintenance and routine monitoring of tanks and equipment will minimise the likelihood of leaks/spills occurring and ensure that any leaks are quickly detected and controlled.

11.0

Failure/Leaks from underground sumps

A sump is located under the tanker unloading area. According to the Condition 6.10 of Vistakon’s IPPC Licence ‘The integrity and water tightness of all underground pipes, tanks, bunding structures and containers and their resistance to penetration by water or other materials carried or stored therein shall be tested and demonstrated by the licensee at least once every three years and reported to the Agency on each occasion. This testing shall be carried out in accordance with any guidance published by the Agency. A written record of all integrity tests and any maintenance or remedial work arising from them shall be maintained by the licensee.’

A bund integrity assessment report was completed in January-February 2009, with results reported in the 2008 AER. Bund integrity assessment shall be repeated at least once every three years, with a planned assessment scheduled for 2012. All remedial works and reassessment have been completed based on the 2009 report.


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12.0

Leak of Fire Water Retention Pond

Water testing will occur every three years in all bunds and will be completed in the Firewater Retention Pond. Condition 3.9.1 of Vistakon’s IPPC licence requires that a reassessment of the existing firewater retention facilities be completed. The main results are as follows:

The LÖRÜRL guide provides a method for calculating required fire water retention for chemical storage areas. This method determined that the maximum required fire water retention capacity at the site is 200m

3.

Under the EPA Draft Guidance Note to Industry on the Requirements for Fire Water Retention Facilities a 60 minute fire event was assessed which resulted in a retention requirement of 289m

3 being determined.

The current design allows for 300m3 retention and is considered to be sufficient to comply with both the LÖRÜRL and EPA

methodologies. Therefore a leak or overspill in the event of a fire from the Fire Water Retention Pond is unlikely. Please refer to 011644-22-RP-001 for more details.

13.0

Uncontrolled releases to Atmosphere from the Thermal Oxidiser (TO)

In the event of a TO failure/shutdown, the process vents will be diverted to the carbon beds. It is anticipated that this will not occur more than 2% of the plant operating time. Modelling has indicated that during this time, Irish and UK ground level Environmental Action Levels will not be exceeded.

14.0

Uncontrolled releases to Atmosphere from the Carbon beds

The Carbon bed is a secondary (backup) abatement method and procedures are in place for regular maintenance and inspection of system.

15.0

Employee struck by large plant or reversing trucks

Proper traffic management system, speed limits and signage is in place. Reversing beacons on machinery.


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16.0

Contaminated water released to the River Mulkear

All vessels and tanks containing hazardous materials are bunded according to the EPA volume requirements, i.e. 110% of the stored volume of the largest vessel in the bund.

In addition to the retention pond, chemical spill response materials, such as absorbent mats, are maintained on-site. An automatic diverter valve is fitted to the surface water system. In the event of a fire alarm or a TOC exceedance, this valve will automatically divert all flow to the fire water retention system, which has a capacity of 300m

3. This system, described in more detail in the

firewater report submitted to and agreed with the EPA, ensures that contaminated firewater or chemical spillages are prevented from entering the River Mulkear and from contaminating surrounding land and hence groundwater.

17.0

Incorrect disposal of waste

All waste contractors on site are licenced operators for the collection and disposal of waste. Waste management procedures in place on site.

18.0

Noise limit exceedance

Annual monitoring at 4No. Boundary location and 2No. Noise sensitive locations as per IPPC licence conditions. Complaints procedure in place.


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5.2 Assessment of Risks

A large number of risks were identified at the Vistakon site and are listed in Table 5.1. These risks were assessed against the risk classification table (RCT) as provided in Table 5.2. The risk classification table was designed to reflect the critical levels of risk appropriate to the site.

Ratings, taken from a risk classification table, were applied to the severity and chance of occurrence of each risk. A risk score was calculated for each risk using the ratings. The risks were then ranked and compared based on the risk scores.

5.2.1 Risk Classification Table

The Risk Classification Table (RCT) has been designed to reflect the critical levels of risk appropriate to the site. The table is provided in Table 5.2 below.

Table 5.2: Risk Classification Table

Rating

Occurrence/ Severity

Occurrence Severity

Category Description Likelihood of

Occurrence (%)

Financial Cost

(€’000’s)

1 V. Low Very low chance (0-5%) of hazard occurring in 30 yr period

0-5 0-1

2 Low Low chance (5-10%) of hazard occurring in 30 yr period

5-10 1-10

3 Medium Medium chance (10-20%) of hazard occurring in 30 yr period

10-20 10-50

4 High High chance (20-50%) of hazard occurring in 30 yr period

20-50 50-100

5 V. High High Greater than 50% chance of hazard occurring in 30 yr period

>50 100-1000

The RCT provides appropriate levels of probability and severity for the ranking of risks. The levels for each parameter reflect suitable levels for assessing and ranking the risks identified at the site, and allocating appropriate management measures.


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5.2.2 Risk Ranking

Risk ratings were applied to each risk for severity and occurrence as taken from the RCT. A risk score was then calculated for each risk using the ratings. The risk score is based on the product of the severity rating and the occurrence rating. This system allowed the risks to be ranked and compared. The risk register listing all the major risks identified at the site was provided in Table 5.1.

Table 5.3 outlines the risk register ranked by risk scores for the site but a more extensive version is explained in Appendix A.

Table 5.3: Risk Register Ranked by Risk Scores

Risk ID

Description Severity Rating

Occurrence Rating

Risk Score

1 Fire at facility 4 2 8

2 Leaks from above ground storage tanks

3 2 6

3 Leaks from underground storage tanks

1 1 1

4 Spillages from bunds 4 2 8

5 Leaks from process and effluent drains

3 3 9

6 Leaks from above ground pipes 3 3 9

7 Overspill from fire water storage at facility

4 2 8

8 Any tank overflows 3 2 6

9 Mobile tanker spills on site 3 3 9

10 Leak/rupture of a container during loading/unloading

3 3 9

11 Leaks from underground sumps 2 1 2

12 Failure/Leak of Fire Water Retention Pond

3 2 6

13 Uncontrolled releases to Atmosphere from the TO

3 2 6

14 Uncontrolled releases to Atmosphere from the Carbon beds

3 2 6

15 Employee Struck by large plant or reversing trucks

4 2 8

16 Contaminated water released to the River Mulkear

3 2 6

17 Incorrect disposal of waste 3 1 3

18 Noise limit exceedance 2 2 4


011644-22-RP-0004_B_01.DOC Page 19 of 36

5.2.3 Risk Matrix

The Risk Matrix has been developed to allow the risks to be easily displayed and prioritised. The severity and occurrence ratings are used in the matrix; with the level of severity forming the x-axis and the likelihood of occurrence forming the y-axis. This matrix will provide a visual tool for regular risk reviews since the success of mitigation can be easily identified. The risk matrix is displayed here in Table 5.4. The risks have been colour coded in the matrix to provide a broad indication of the critical nature of each risk. The colour code is as follows:

• Red – These are considered to be high-level risks requiring priority attention. These risks have the potential to be catastrophic and as such should be addressed quickly.

• Amber / Yellow – These are medium-level risks requiring action, but are not as critical as a red coded risk.

• Green (light and dark green) – These are lowest-level risks and indicate a need for continuing awareness and monitoring on a regular basis. Whilst they are currently low or minor risks, some have the potential to increase to medium or even high-level risks and must therefore be regularly monitored and if cost effective mitigation can be carried out to reduce the risk even further this should be pursued.

Table 5.4: Risk Matrix

Occu

rren

ce

V. High

5

High

4

Medium

3 5,6,9,10

Low

2 18 2,12,13,14,16, 8

1,4,7,15

V. Low

1 3 11 17

V. Low Low Medium High V. High

1

2 3 4 5

Severity

The risk matrix indicates that there are no risks in the red or yellow/amber zone requiring priority attention. All remaining risks are located in the green zone indicating a need for continuing awareness and monitoring on a regular basis.


011644-22-RP-0004_B_01.DOC Page 20 of 36

5.2.4 Discussion of Risk Levels

All risks lie in the green zone. These risks require continuing awareness and monitoring on a regular basis. If not carried out these risks may have the potential to increase to yellow or red zone risks.

The main areas which need to be maintained are:

• Complaints procedure;

• Annual noise monitoring;

• All vessels and tanks containing hazardous materials are bunded according to the EPA volume requirements, i.e. 110% of the stored volume of the largest vessel in the bund;

• Use of approved waste contractors;

• Use of chemical spill response materials, such as absorbent mats;

• Proper traffic management system;

• Testing and demonstration of the integrity and water tightness of all underground pipes, tanks, bunding structures and containers (to occur every three years);

• Preventative maintenance and routine monitoring of tanks and equipment;

• Unloading of Bulk Chemicals procedure;

• Surface water drains are protected against spillage when unloading by control valves;

• Vistakon personnel must be present when loading/unloading occurs;

• Any leaks identified are repaired as soon as practicable;

• All bunds are designed, tested and operated in accordance with the requirements of the EPA Guidance Note on the Storage and Transfer of Materials for Scheduled Activities.

The continued mitigation measures above and regular monitoring and maintenance should keep the risks in the low or minor risk category and prevent them from increasing to medium or even high-level risks.

5.3 Identification and Assessment of Mitigation Actions

5.3.1 Identification of Mitigation Actions

Table 5.5 provides the risks in descending order of risk score with the proposed mitigation measure. The current controls are also provided.


011644-22-RP-0004_B_01.DOC Page 21 of 36

5.3.2 Effectiveness of Mitigation Measures in Risk Reduction

The Risk Scores can be re-calculated on the basis that the mitigation measures are fully implemented. Table 5.5 provides the revised risk scores after the implementation of the risk mitigation measures, and compares them to the current risk score.

Note: All of the risks were judged to have satisfactory current risk controls and additional mitigation measures were not identified. In this instance the Risk owner is required to ensure that the current risk levels of control are maintained and that the level of risk does not increase.


011644-22-RP-0004_B_01.DOC Page 22 of 36

Table 5.5: Risk Mitigation Measures

Risk Potential Failure

Mode/Risk Current Controls

Recommended Mitigation Measures

Current Risk Score

Revised Risk Score

9 Mobile tanker spills on site Site personnel monitoring when unloading. Spill clean up equipment and procedures for tankers loading/unloading in place. Unloading is carried out in bunded area

None – actions in place already results in low risk (any risks score above 15 would be considered medium to high level risks requiring action)

9 9

10 Leak/rupture of a container during loading/unloading

Site personnel monitoring when unloading. Spill clean up equipment and procedures for tankers loading/unloading in place Unloading is carried out in bunded area

None – actions in place already results in low risk

9 9

5 Leaks from process and effluent drains

Routine maintenance / monitoring and procedures in place


9 9

6 Leaks from above ground pipes

Routine maintenance / monitoring and procedures in place / valve positioning allows for shutting-off supply


9 9

15 Employee struck by large plant or reversing trucks

Proper traffic management system and signage is in place. Reversing beacons on machinery


8 8

7 Failure/overspill from fire water storage tanks at facility

Routine maintenance / monitoring and procedures in place


8 8

1 Fire at facility Control of ignition sources; smoking banned; correct electric installations; proper welding tools and inspection of


8 8


011644-22-RP-0004_B_01.DOC Page 23 of 36




Current Risk Score

Revised Risk Score

waste. Fire training of all personnel. Maintenance of site security procedures

4 Spillages from bunds Routine maintenance / monitoring and procedures in place


8 8

12 Leak of Fire Water Retention Pond

Routine maintenance and monitoring. None – actions in place already results in low risk

6 6

2 Leaks from above ground storage tanks

Routine maintenance / monitoring and procedures in place / good design and procedural controls / any spills or fire water run-off will be contained in bund / spill response procedure / equipment & trained operators to respond to spill


6 6

8 Any tank overflows 110% bund capacity and water tightness test occurs every 3 years


6 6

13 Uncontrolled releases to Atmosphere from the TO

Routine maintenance and monitoring. Continuous gas monitoring on site. Procedure for regular maintenance and inspection of system


6 6

14 Uncontrolled releases to Atmosphere from the Carbon beds

Routine maintenance and monitoring. Continuous monitoring on site


6 6

16 Contaminated water released to the River Mulkear

Maintenance and continuous monitoring of TOC.


6 6


011644-22-RP-0004_B_01.DOC Page 24 of 36




Current Risk Score

Revised Risk Score

18 Noise limit exceedance Annual monitoring at 4 no. boundary locations and 2 no. noise sensitive locations as per IPPC licence conditions. Complaints procedure in place.


4 4

17 Incorrect disposal of waste All waste contractors on site are licenced operators for the collection and disposal of waste. Waste management procedures in place on site. Audit of waste contractors (three year audit cycle) and maintenance of disposal records


3 3

11 Leaks from underground sumps

Routine maintenance and monitoring. None – actions in place already results in low risk

2 2

3 Leaks from underground storage tanks

Routine maintenance / monitoring and procedures in place and water tightness test occur every three years as per IPPC Licence conditions.


1 1


011644-22-RP-0004_B_01.DOC Page 25 of 36

5.4 Risk Management Programme

5.4.1 General

Every risk requires a certain amount of management in order to reduce the risk or manage the risk at an acceptable level. Risk owners have therefore been allocated to each risk to undertake this role. For the all of the risks identified, the management of the risk will involve the maintenance of current controls.

The risks were judged to have satisfactory current risk controls and additional mitigation measures were not identified. In this instance the Risk owner is required to ensure that the current levels of controls are maintained and that the level of risk does not increase.

5.4.2 Risk Management Programme

The risk owner must be someone competent enough to understand the risk and the suggested mitigation proposals for that risk, and have the authority to implement the mitigation measure. The risk owner must also be able to be held ultimately responsible for the risk also. The person considered suitable to act as risk owner at the site is:

• Facilities Director

• EHS Manager

The proposed timescales for the implementation of the mitigation measures must be realistic and appropriate to the level of risk. The mitigation measures have been assigned to various risk owners and a timescale selected. A list of these measures, owners and a timescale has been tabulated in Table 5.6 grouped by the owner. It should however be noted that ultimately the company is responsible and is the risk owner for all of the risks at the site.


011644-22-RP-0004_B_01.DOC Page 26 of 36

Table 5.6: Proposed Risk Mitigation Measures and Maintenance of Current Controls with owners and timescales

Owner Risk Mitigation

Measures/Maintenance Current Controls

Relevant Risk ID

Mitigation Measure Completion Date

Facilities Director


Enforcement of speed limits and traffic management procedures

15 Current Controls in place

Facilities Director

Mobile tanker spills on site / Leak/rupture of a container during loading/unloading.

Maintenance of spill clean up equipment and procedures for tankers loading/unloading in place

9,10 Current Controls in place

Facilities Director

Leak/rupture of a container during loading/unloading.

Routine maintenance and monitoring.

6,11 Current Controls in place

Facilities Director

Failure/overspill from fire water storage tanks at facility

110% bund capacity should be applied to all tanks


Facilities Director

Fire at facility Regular and appropriate fire training of all personnel to be carried out.


Facilities Director

Fire at facility Review site security and assess risk of vandalism or arson


Facilities Director

Leaks from underground storage tanks / Any tank overflows / Leaks from above ground storage tanks / Leak of FWRP / Spillages from bunds / Leaks from process and effluent drains

Water tightness test occurs every 3 years

4,12,2,8,3,5 Part of the preventative main system

Facilities Director

Uncontrolled releases to Atmosphere from the Carbon beds/ Uncontrolled releases to Atmosphere from the TO

Procedure for regular maintenance and inspection of system

13,14 Part of the preventative main system

Facilities Director


Maintenance and monitoring of TOC meter

16 Part of the preventative main system

Facilities Director

Incorrect disposal of waste

Audit of waste contractors and maintenance of disposal records

17 Current controls in place (ongoing three year audit cycle)


011644-22-RP-0004_B_01.DOC Page 27 of 36

Owner Risk Mitigation

Measures/Maintenance Current Controls

Relevant Risk ID

Mitigation Measure Completion Date

Facilities Director


Annual site noise survey be completed

18 Noise survey completed annually in accordance with conditions of IPPC Licence


011644-22-RP-0004_B_01.DOC Page 28 of 36

6. ASSESSMENT OF POTENTIAL ENVIRONMENTAL LIABILITIES

6.1 Types of Environmental Liabilities

The assessment of potential environmental liabilities can be broken down into two separate sections, the “known” environmental liabilities and the potential or “unknown” environmental liabilities associated with the environmental risks identified at the site.

The “known” environmental liabilities are those liabilities associated with environmental protection events that will definitely occur in the course of the life of the facility. This includes the decommissioning of the site and costs associated with that which are discussed in the Decommissioning Management Plan (DMP) for the site. The “unknown” environmental liabilities are those that may or may not arise due to the occurrence of the environmental risks identified in the risk assessment.

6.2 ‘Unknown’ Environmental Liabilities – Current Status

The ‘unknown’ environmental liabilities are associated with the environmental risks at the site and may or may not occur. The best case scenario is that none of the environmental risks occur, and hence at the end of the assessment period of 30 years, the additional costs incurred by Vistakon due to the environmental risks are zero. Alternatively, should a significant number of the risks materialise, significant additional costs could be incurred.

The known environmental liabilities for the site have already been calculated through the preparation and costing of the DMP (PM document 011644-22-RP-0003 Issue B).

For unknown liabilities associated with the environmental risks identified above (Appendix B), the following methodology has been used:

1. The probability of occurrence of each risk is assigned a percentage value as per Table 5.2;

2. This model considers the most likely scenario and so uses the median probability of the occurrence of the risk;

3. The cost implication given in Table 4.1 is based on the severity rating, considering the sector in which the site operates;

4. Multiplying the cost range by the median probability gives the most likely scenario cost;

5. A factor of 20% for contingency has then been added to each scenario cost;

The Most Likely Scenario Financial Model Table is included as Appendix B.

The maximum estimated cost of unknown environmental liability is €66,375 (including a contingency of 20%).


011644-22-RP-0004_B_01.DOC Page 29 of 36

6.3 Review of Risk Assessment

The Environmental Liabilities Risk Assessment will be further reviewed as necessary to reflect any significant change on site, and in any case every three years, as per Condition 12.3 of the licence.

Table 6.1: Summary of Potential “Unknown” Environmental Liabilities

Description Estimate of

“Unknown”Environmental Liabilities

Assumptions

Highest Cost Scenario € 971,000 Assumes all risks occur at their maximum cost

Lowest Cost Scenario € 0 Assumes none of the risks occur

Most Likely Scenario € 66,375

Based on median probability and severity for each risk after implementation of control measures


011644-22-RP-0004_B_01.DOC Page 30 of 36

7. FINANCIAL PROVISION

The main objective of financial provision is to ensure that sufficient financial resources are available to cover:

• Known environmental liabilities that will arise at the time of facility closure

• Known environmental liabilities that are associated with the aftercare and maintenance of the facility until such time as the facility is considered to no longer pose a risk to the environment

• Unknown environmental liabilities that may occur during the operating life of the facility.

7.1 Unknown Environmental Liabilities

The greatest likely scenario cost of an unknown environmental liability relating to the site is given by this Risk Assessment as €66,375 (including 20% contingency).

Unknown environmental liabilities that could occur during the aftercare phase and post-surrender of the licence have not been specifically addressed. It is considered that the likelihood of occurrence of such liabilities will be extremely low, provided that all significant environmental issues are identified and addressed during the closure, restoration and aftercare phases, as per the Decommissioning Management Plan (PM report number 011644-22-RP-0003 Issue B).

Financial provision encompasses two aspects:

• Quantifying the financial amount of the environmental liabilities (known and unknown), and

• Selecting appropriate financial instrument(s) to underwrite the liabilities.

The amount of financial provisions required for the facility was determined using the DMP and ELRA. The known liabilities established in the DMP are of the order of €475,800; associated costs with regard to the unknown liabilities in the ELRA are €66,375. In combination, these give a total required financial provision for the site of €542,175.

The financial provisions made by Vistakon to address unknown environmental liabilities will be further reviewed and revised as necessary, at least annually, per Condition 12.3 of the licence. Vistakon also confirms that the company has more than adequate resources from operations to fund the ELRA. In addition, the value of the facility itself as a fixed asset worth in excess of €134m will far outweigh any remediation cost.


011644-22-RP-0004_B_01.DOC Page 31 of 36

APPENDIX A

RISK ASSESSMENT TABLE


011644-22-RP-0004_B_01.DOC Page 32 of 36

Table 5.3-A: Risk Register Ranked by Risk Scores

Risk ID

Process Potential Hazards Environmental

Effect Severity Rating

Basis of Severity Occurrence

Rating Basis of

Occurrence

Risk Score (severity x

occurrence)

1 Fire or explosion Fire at facility Contamination of air and firewater

4 Potential for smoke, fume, odorous, irritating and harmful gases and vapours to be released off-site. Could cause contamination of the local environment and local residences

2 Assumes low probability

8

2 Storage tanks Leaks from above ground storage tanks

Surface and Groundwater contamination

3 Cost of remediation 2 Assumes low probability

6

3 Storage tanks Leaks from underground storage tanks


1 Cost of remediation 1 Low level due to high level of control

1

4 Spillages during transfer of materials

Spillages from bunds



8

5 Effluent from all of the processes and sanitary waste

Leaks from process and effluent drains


3 Cost of remediation 3 Medium probability

9

6 Leaks from above ground process pipes carrying liquids

Leaks from above ground pipes



9

7 Flammable Solvent Storage in Tank Farm

Overspill from fire water storage at facility



8

8 Storage tanks Any tank overflows Surface and 3 Cost of remediation 2 Assumes low 6


011644-22-RP-0004_B_01.DOC Page 33 of 36

Risk ID




Rating Basis of

Occurrence


occurrence)

Groundwater contamination

probability

9 Spillages during transfer of materials

Mobile tanker spills on site



9

10 Leaks during transfer of materials

Leak/rupture of a container during loading/unloading



9

11 Storage tanks Leaks from underground sumps


2 Cost of remediation 1 Low level due to high level of control

2

12 Construction Failure/Leak of Fire Water Retention Pond



6

13 Process use and recovery of solvents

Uncontrolled releases to Atmosphere from the TO

Impact to local air quality

3 Could cause contamination of the local environment and local residences


6

14 Process use and recovery of solvents

Uncontrolled releases to Atmosphere from the Carbon beds

Impact to local air quality

3 Could cause contamination of the local environment and local residences


6

15 Movement of vehicles on site


Health impact on human beings

4 Rehabilitation costs 2 Assumes low probability

8

16 Failure of TOC equipment


Surface water contamination


6


011644-22-RP-0004_B_01.DOC Page 34 of 36

Risk ID




Rating Basis of

Occurrence


occurrence)

17 Waste Contractors Incorrect disposal of waste

Soil/ Groundwater contamination

3 Cost of soil and groundwater remediation

1 Low level due to high level of control

3

18 Noise is generated by process and utilities equipment and site activities such as transport and construction


Noise impact, causing nuisance to local residences

2 Minor once off events, but nuisance level rises with rising incidences


4


011644-22-RP-0004_B_01.DOC Page 35 of 36

APPENDIX B

FINANCIAL MODEL – MOST LIKELY SCENARIO


011644-22-RP-0004_B_01.DOC Page 36 of 36

Risk ID

Severity Rating

Cost Rating (€’000’s)

Median Severity (€)

Occurrence Rating

Occurrence Probability Range

(%)

Median Occurrence

Probability (%)

Most likely Scenario Cost - median

severity x median probability (€)

Most likely Scenario Cost +

20% contingency (€)

1 4 50-100 75,000 2 5-10 7.5 5,625 6,750

2 3 10-50 30,000 2 5-10 7.5 2,250 2,700

3 1 0-1 500 1 0-5 2.5 13 15

4 4 50-100 75,000 2 5-10 7.5 5,625 6,750

5 3 10-50 30,000 3 10-20 15 4,500 5,400

6 3 10-50 30,000 3 10-20 15 4,500 5,400

7 4 50-100 75,000 2 5-10 7.5 5,625 6,750

8 3 10-50 30,000 2 5-10 7.5 2,250 2,700

9 3 10-50 30,000 3 10-20 15 4,500 5,400

10 3 10-50 30,000 3 10-20 15 4,500 5,400

11 2 1-10 5,500 1 0-5 2.5 138 165

12 3 10-50 30,000 2 5-10 7.5 2,250 2,700

13 3 10-50 30,000 2 5-10 7.5 2,250 2,700

14 3 10-50 30,000 2 5-10 7.5 2,250 2,700

15 4 50-100 75,000 2 5-10 7.5 5,625 6,750

16 3 10-50 30,000 2 5-10 7.5 2,250 2,700

17 3 10-50 30,000 1 0-5 2.5 750 900

18 2 1-10 5,500 2 5-10 7.5 413 495

Total 55,313 66,375


AER Attachment No. 8: Groundwater Monitoring Data

MARCH 2011

VISTAKON IRELAND LIMITEDGROUNDWATER MONITORING

IPPC Groundwater MonitoringDecember 2010

REPO

RT

Report Number. 10507140021.R3.A0

Distribution:

2 Copies Vistakon Johnson & Johnson

1 Copy - Golder Associates

Submitted to:

EHS ManagerVistakon Johnson & JohnsonNational Technological ParkCastletroyLimerick

March 2010


IPPC Biannual GroundwaterMonitoring - February 2010

REPO

RT

Report Number: 1050714021R.1/A.0

Submitted to:

EHS Manager,Vistakon Johnson & Johnson,National Technological Park,Castletroy,Limerick.

IPPC BIANNUAL GROUNDWATER MONITORING - FEBRUARY2010

March 2010Report No. 1050714021R.1/A.0

Record of Issue

Company Client Contact Version Date Issued Method of Delivery

Vistakon Johnson &

Johnson

Margaret Stokes B.0

Vistakon Johnson &

Johnson

Margaret Stokes A.0


March 2010Report No. 1050714021R.1/A.0 i

Table of Contents

1.0 INTRODUCTION ........................................................................................................................................................1

2.0 SCOPE OF WORKS ..................................................................................................................................................1

3.0 RESULTS...................................................................................................................................................................2

3.1 Groundwater Levels ......................................................................................................................................2

3.2 Groundwater Sampling and Field Results.....................................................................................................2

3.3 Results of Laboratory Analysis on Groundwater Samples ............................................................................3

3.4 Groundwater Flow Direction..........................................................................................................................4

4.0 CONCLUSIONS AND RECOMMENDATIONS ..........................................................................................................6

TABLES

Table 1: Groundwater Monitoring Well Water Levels & Depths...........................................................................................2

Table 2: Field Results..........................................................................................................................................................3

Table 3: Results of Analysis ................................................................................................................................................5

FIGURES

Figure 1 Site Location Map

Figure 2 Site Layout Map

Figure 3 Groundwater Contour Plan

APPENDICES

Appendix A Groundwater Monitoring Results – VOCs and SVOCs


March 2010Report No. 1050714021R.1/A.0 1

1.0 INTRODUCTION

This report details the findings of biannual groundwater monitoring conducted in February 2010 at the

Vistakon Johnson & Johnson Plant. The plant is located at the National Technological Park, Castletroy, on

the outskirts of Limerick City (Figure 1).

The plant was established in Limerick in 1996 and now employs some 1,000 people. They are one of the

largest producers of disposable contact lenses in the world.

As part of their Integrated Pollution Prevention and Control Licence (IPPC) Ref: No. P0818-01, biannual

groundwater monitoring must be carried out on four groundwater monitoring wells located around the

boundary of the Facility (Figure 2).

2.0 SCOPE OF WORKS

A scope of works was specified by Vistakon and was detailed in the proposal (No. P10507140021/P.1/V.0)

submitted in January 2010. This included carrying out the following:

Undertaking a Global Positioning System (GPS) survey to accurately define the locations and

elevations of four groundwater monitoring locations to derive the groundwater flow direction across

the Site.

Water level measurement (‘dip round’) indicating depth to groundwater in all wells;

Well purging to remove stagnant water from each well to ensure that a groundwater sample

representative of that in the aquifer is collected for laboratory analysis;

Measurement of unstable water quality parameters (pH, temperature, electrical conductivity, redox

potential and dissolved oxygen) using a calibrated field meter;

Collection of groundwater samples for laboratory analysis. Samples will be collected in laboratory

supplied sample containers by experienced field staff to ensure sample integrity. Where necessary,

samples will be filtered in the field; and

Completion of appropriate Chain of Custody (COC) documentation for sample traceability purposes

and dispatch of samples to the laboratory by overnight courier;



3.0 RESULTS

3.1 Groundwater Levels

A GPS survey was undertaken to confirm locations and establish the top of casing (TOC) levels of the four

monitoring wells on-Site so a groundwater contour map could be derived from the dipped water levels.

Depths from the top of casing (TOC) to water level were recorded and are tabulated in Table 1 below.

Groundwater levels were measured in all four groundwater monitoring wells; GW1, GW2, GW3 and GW4.

GW3 is an abstraction well with water being used as part of the manufacturing process at the facility. This

well is likely to be subject to a cone of depression due to continuous abstraction. Water level monitoring was

undertaken in all four groundwater monitoring wells using a Solinst Water Level Meter and conducted in

accordance with Golder Associates (Golders) procedures for water level monitoring.

Table 1 also shows water levels in meters Ordnance Datum (mOD). Figure 3 attached at the end of this

report illustrates the groundwater flow direction across the site.

Table 1: Groundwater Monitoring Well Water Levels & Depths

Monitoring WellTop of Casing

(TOC)levelGroundwater Level

ID (mOD) (mBTOC) mOD

GW 1 13.03 1.58 11.45

GW 2 11.24 2.93 8.32

GW 3 10.10 10.31 -0.21

GW 4 12.53 1.77 10.76

3.2 Groundwater Sampling and Field Results

Dedicated Waterra Highflow inertial lift tubing and stainless steel foot valves had been installed in GW1,

GW2 and GW4 during previous monitoring rounds. A Waterra Inertial Pump connected to the dedicated

tubing was used to abstract at least three borehole volumes to ensure a representative sample was collected

for laboratory analysis. A sampling tap leading from the rising main was used to retrieve the sample at GW3.

This was let run for several minutes before filling the sampling containers.

Field parameters were measured during purging and sampling of the monitoring wells. These are tabulated

in Table 2 below. A Hanna Multi-parameter meter was used to measure field parameters. This was

calibrated prior to undertaking the sampling round. Field parameters were all within the accepted ranges of

the EPA’s Interim Guideline values (IGV’s).



Samples recovered from GW1 & GW2 were very silty with sediment settling at the bottom of the containers

once recovered. GW3 & GW4 were relatively clear and free of silt. The sampling method employed would

lead to some disturbance of sediments particularly in shallow overburden wells giving a silty sample.

Groundwater sampling was carried out in accordance with Golders procedures for groundwater monitoring.

Table 2: Field Results

Monitoring Well pH Temperature Conductivity Dissolved Oxygen

ID ⁰C µS/cm mg/L

GW 1 7.1 8.9 763 9.0

GW 2 7.4 8.2 945 9.0

GW 3 7.3 10.2 735 7.0

GW 4 7.2 10.1 716 3.0

3.3 Results of Laboratory Analysis on Groundwater Samples

All groundwater samples were collected in laboratory supplied containers and stored in a cooler box with ice

packs. The laboratory Chain of Custody (COC) was completed and samples were couriered to Jones

Environmental Laboratories in the United Kingdom. Results of analysis are tabulated in Table 3 and are

compared to the EPA’s Interim Guideline Values (IGV) with exceedances highlighted in red for identification

purposes.

A duplicate sample of GW 3 was included for QA/QC purposes and sent to the laboratory for analysis.

These results are also tabulated in Table 3 and denoted GW3/D. An ionic balance was carried out on the

results supplied for the four monitoring wells to check the quality of the data supplied by the lab. This ranged

between 0.11% and 4.51% for the five samples. An ionic balance of less than 10% is deemed acceptable

for laboratory data. All Volatile Organic Compound (VOC) and Semi Volatile Organic Compound (SVOC)

parameters analysed for were below laboratory Limits of Detection (LODs). These are included in Appendix

A located at the end of this report.

The recommended IGV level for Chloride is 30 mg/L. This was exceeded in GW 2 (45.1 mg/L) and GW 3

(46.6 mg/L). These were the only exceedances identified in this monitoring round. Whilst not present in

alarming concentrations, sodium is also slightly elevated in GW2 and Gw3 compared to the other wells

suggesting a possible saline intrusion.

GW2 and GW3 which both show exceedances are located towards the north west of the site with a distance

of ca.137m between them while GW1 and GW4 are located ca. 360m and 380m respectively south east of

GW3 and neither of these exceeded the guideline value of 30mg/L.



3.4 Groundwater Flow Direction

Figure 3 illustrates the groundwater contour levels across the site compiled using water levels taken on the

day of monitoring for the four monitoring wells. The groundwater contour plan shows a positive gradient

from GW1, GW2 & GW4 towards GW3. As stated previously the continuous abstraction of water from GW3

gives rise to a cone of depression with water moving from around the site towards this abstraction point. This

could also lead to groundwater outside the boundary of the site flowing towards GW2 and GW3 particularly

from the north western boundary.

IPPC BIANNUAL GROUNDWATER MONITORING - FEBRUARY 2010


Table 3: Results of Analysis

Parameter Name Units EPA GW1 GW2 GW3 GW3D GW4

Lab ID IGV's

Alkalinity (Total) mg/L CaCO3 - 352 400 340 344 376

pH pH Units ≥6.5 and

≤9.5

7.42 7.27 7.86 7.83 7.47

Conductivity (Groundwater) µS/cm -

1@25C

1000 725 935 820 806 771

Redox Potential m/v 175 158 151 147 157

COD (Ground Water) mg/L - <7 7 <7 <7 <7

Solids (Total Suspended) mg/L - 1996 5737 13 <10 <10

Sodium mg/L 150 10.94 22.71 25.00 24.59 13.63

Potassium mg/L 5 1.90 1.90 1.24 1.22 1.41

Magnesium mg/L 50 12.32 31.81 19.39 19.12 12.25

Calcium mg/L 200 138.60 145.30 118.20 116.10 131.40

Ammonia mg/L as N 0.155 <0.23 <0.23 <0.23 <0.23 <0.23

Ammonia mg/L as NH4 - <0.3 <0.3 <0.3 <0.3 <0.3

Fluoride mg/L 1 <0.3 <0.3 <0.3 <0.3 <0.3

Chloride mg/L 30 22.4 45.1 46.6 46.5 28.2

Cyanide µg/L 10 <40 <40 <40 <40 <40

Phosphate (Ortho) mg/L as P - <0.01 <0.01 <0.01 <0.01 <0.01

Phosphate (Ortho) mg/L as PO43-

0.03 <0.03 <0.03 <0.03 <0.03 <0.03

Nitrite mg/L as N - <0.006 <0.006 <0.006 <0.006 <0.006

Nitrite mg/L as N02-

0.1 <0.02 <0.02 <0.02 <0.02 <0.02

Nitrate mg/L as N - 0.16 0.54 0.32 0.68 0.25

Nitrate mg/L as N032-

25 0.7 2.4 1.4 3.0 1.1

Sulphate mg/L as SO4 200 22.94 29.81 22.96 22.89 22.04

Semi Volatile Organic Compounds

(Total)

µg/L See Appendix A See Appendix A See Appendix A See Appendix A See Appendix A

Volatile Organic Compounds (Total) µg/L See Appendix A See Appendix A See Appendix A See Appendix A See Appendix A


6

4.0 CONCLUSIONS AND RECOMMENDATIONS

All parameters were below the recommended guideline values except chloride in two wells. As stated, levels

of chloride were elevated in previous rounds of groundwater monitoring carried out. This may be associated

with a saline influence.

Groundwater monitoring is carried out biannually as specified in the IPPC Licence. It is recommended that a

review of data is undertaken to assess groundwater quality is improvements over time.


8

FIGURES

TOWN CENTRE HOUSE, DUBLIN ROAD, NAAS, CO. KILDARETEL.: 045 874411 - FAX:045 874549

www.golder.com - email:[email protected]

VISTAKON (JOHNSON & JOHNSON)

LIMERICK

IPPC GROUNDWATER MONITORING

SITE LOCATION MAPPOB

CC

DK

10.5071.4.0021

N.T.S

01CLIENT Feb. '10 A

SITE

LOCATION

ORDNANCE SURVEY IRELAND LICENCE NUMBER

AR0056010

File Location

GW3GW2

GW4

GW1

SITE LAYOUT MAPVISTAKON (JOHNSON & JOHNSON)

Client:


Project:

LIMERICK

Location:

Title:

1:2,000 A3 1:3,000 A4

Scale

10.5071.4.0021

02ORDNANCE SURVEY IRELAND LICENCE NUMBER

AR0056010

Issue to Date

Feb. '10 ATO CLIENT

DrawingProject number

File LocationGRAPHICS (JULY 2008)/MANUFACTURING/

VISTAKON/AS-BUILT/AUTOCAD/SET/02-feb10

Reviewed by

Checked by

Created By Version

CC

DK

POB

NOTES:

GW1 BOREHOLE LOCATION& REFERENCE NUMBER

GW3GW2

GW4

GW1

7.0

8.0

9.0

10.0

11.0

3.0

4.0

5.0

6.0

2.0

1.0

2.0

3.0

4.0

5.0

6.0

7.0

8.0

9.0

10.0

GROUNDWATER CONTOUR PLAN- February 2010 dip levels

VISTAKON (JOHNSON & JOHNSON)

Client:


Project:

LIMERICK

Location:

Title:

1:2,000 A3 1:3,000 A4

Scale

10.5071.4.0021

03ORDNANCE SURVEY IRELAND LICENCE NUMBER

AR0056010

Issue to Date

Feb. '10 ATO CLIENT

DrawingProject number

File LocationGRAPHICS (JULY 2008)/MANUFACTURING/

VISTAKON/AS-BUILT/AUTOCAD/SET/03-feb10

Reviewed by

Checked by

Created By Version

CC

DK

POB

NOTES:

GW1 BOREHOLE LOCATION

& REFERENCE NUMBER

10.00 FEBRUARY 2010GROUNDWATER CONTOUR


9

APPENDIX AGroundwater Monitoring Results – VOCs and SVOCs

Sample ID GW1 GW2 GW3 GW4 GW3D

Sample Date 09/02/10 09/02/10 09/02/10 09/02/10 09/02/10

Dichlorodifluoromethane <2 μg/l <2 <2 <2 <2 <2

Methyl Tertiary Butyl Ether <2 μg/l <2 <2 <2 <2 <2

Chloromethane# <3 μg/l <3 <3 <3 <3 <3

Vinyl Chloride <2 μg/l <2 <2 <2 <2 <2

Bromomethane <1 μg/l <1 <1 <1 <1 <1

Chloroethane# <3 μg/l <3 <3 <3 <3 <3

Trichlorofluoromethane# <3 μg/l <3 <3 <3 <3 <3

1,1-Dichloroethene# <6 μg/l <6 <6 <6 <6 <6

Carbon Disulphide# <3 μg/l NA NA NA NA NA

Dichloromethane# <3 μg/l <3 <3 <3 <3 <3

trans-1-2-Dichloroethene# <3 μg/l <3 <3 <3 <3 <3

1,1-Dichloroethane# <3 μg/l <3 <3 <3 <3 <3

cis-1-2-Dichloroethene# <3 μg/l <3 <3 <3 <3 <3

2,2-Dichloropropane <1 μg/l <1 <1 <1 <1 <1

Bromochloromethane# <2 μg/l <2 <2 <2 <2 <2

Chloroform# <3 μg/l <3 <3 <3 <3 <3

1,1,1-Trichloroethane# <3 μg/l <3 <3 <3 <3 <3

1,1-Dichloropropene# <3 μg/l <3 <3 <3 <3 <3

Carbon tetrachloride# <2 μg/l <2 <2 <2 <2 <2

1,2-Dichloroethane# <2 μg/l <2 <2 <2 <2 <2

Benzene# <3 μg/l <3 <3 <3 <3 <3

Trichloroethene <3 μg/l <3 <3 <3 <3 <3

1,2-Dichloropropane# <2 μg/l <2 <2 <2 <2 <2

Dibromomethane# <3 μg/l <3 <3 <3 <3 <3

Bromodichloromethane# <3 μg/l <3 <3 <3 <3 <3

cis-1-3-Dichloropropene# <2 μg/l <2 <2 <2 <2 <2

Toluene# <3 μg/l <3 <3 <3 <3 <3

trans-1-3-Dichloropropene# <2 μg/l <2 <2 <2 <2 <2

1,1,2-Trichloroethane# <2 μg/l <2 <2 <2 <2 <2

Tetrachloroethene# <3 μg/l <3 <3 <3 <3 <3

1,3-Dichloropropane# <2 μg/l <2 <2 <2 <2 <2

Dibromochloromethane# <2 μg/l <2 <2 <2 <2 <2

1,2-Dibromoethane# <2 μg/l <2 <2 <2 <2 <2

Chlorobenzene# <2 μg/l <2 <2 <2 <2 <2

1,1,1,2-Tetrachloroethane# <2 μg/l <2 <2 <2 <2 <2

Ethylbenzene# <3 μg/l <3 <3 <3 <3 <3

p/m-Xylene# <5 μg/l <5 <5 <5 <5 <5

o-Xylene# <3 μg/l <3 <3 <3 <3 <3

Styrene# <2 μg/l <2 <2 <2 <2 <2

Bromoform# <2 μg/l <2 <2 <2 <2 <2

Isopropylbenzene# <3 μg/l <3 <3 <3 <3 <3

1,1,2,2-Tetrachloroethane <4 μg/l <4 <4 <4 <4 <4

Bromobenzene# <2 μg/l <2 <2 <2 <2 <2

1,2,3-Trichloropropane# <3 μg/l <3 <3 <3 <3 <3

Propylbenzene# <3 μg/l <3 <3 <3 <3 <3

2-Chlorotoluene# <3 μg/l <3 <3 <3 <3 <3

1,3,5-Trimethylbenzene# <3 μg/l <3 <3 <3 <3 <3

4-Chlorotoluene# <3 μg/l <3 <3 <3 <3 <3

tert-Butylbenzene# <3 μg/l <3 <3 <3 <3 <3

1,2,4-Trimethylbenzene# <3 μg/l <3 <3 <3 <3 <3

sec-Butylbenzene# <3 μg/l <3 <3 <3 <3 <3

4-Isopropyltoluene# <3 μg/l <3 <3 <3 <3 <3

1,3-Dichlorobenzene# <3 μg/l <3 <3 <3 <3 <3


n-Butylbenzene# <3 μg/l <3 <3 <3 <3 <3


1,2-Dibromo-3-chloropropane <2 μg/l <2 <2 <2 <2 <2

1,2,4-Trichlorobenzene <3 μg/l <3 <3 <3 <3 <3

Hexachlorobutadiene#

<3 μg/l <3 <3 <3 <3 <3

Naphthalene <2 μg/l <2 <2 <2 <2 <2

1,2,3-Trichlorobenzene <3 μg/l <3 <3 <3 <3 <3

VOCs

LOD Units

Sample Date GW1 GW2 GW3 GW4 GW3D

Batch Number 09/02/10 09/02/10 09/02/10 09/02/10 09/02/10

Phenols

2-Chlorophenol <10 μg/ l <10 <10 <10 <10 <10

2-Methylphenol <10 μg/ l <10 <10 <10 <10 <10

2-Nitrophenol <10 μg/ l <10 <10 <10 <10 <10

2,4-Dichlorophenol <10 μg/ l <10 <10 <10 <10 <10

2,4-Dimethylphenol <10 μg/ l <10 <10 <10 <10 <10

2,4,5-Trichlorophenol <10 μg/ l <10 <10 <10 <10 <10

2,4,6-Trichlorophenol <10 μg/ l <10 <10 <10 <10 <10

4-Chloro-3-methylphenol <10 μg/ l <10 <10 <10 <10 <10

4-Methylphenol <10 μg/ l <10 <10 <10 <10 <10

4-Nitrophenol <10 μg/ l <10 <10 <10 <10 <10

Pentachlorophenol <10 μg/ l <10 <10 <10 <10 <10

Phenol <10 μg/ l <10 <10 <10 <10 <10

PAHs

2-Chloronaphthalene <10 μg/ l <10 <10 <10 <10 <10

2-Methylnaphthalene <10 μg/ l <10 <10 <10 <10 <10

Naphthalene <10 μg/ l <10 <10 <10 <10 <10

Acenaphthylene <10 μg/ l <10 <10 <10 <10 <10

Acenaphthene <10 μg/ l <10 <10 <10 <10 <10

Fluorene <10 μg/ l <10 <10 <10 <10 <10

Phenanthrene <10 μg/ l <10 <10 <10 <10 <10

Anthracene <10 μg/ l <10 <10 <10 <10 <10

Fluoranthene <10 μg/ l <10 <10 <10 <10 <10

Pyrene <10 μg/ l <10 <10 <10 <10 <10

Benz(a)anthracene <10 μg/ l <10 <10 <10 <10 <10

Chrysene <10 μg/ l <10 <10 <10 <10 <10

Benzo(bk)fluoranthene <10 μg/ l <10 <10 <10 <10 <10

Benzo(a)pyrene <10 μg/ l <10 <10 <10 <10 <10

Indeno(123cd)pyrene <10 μg/ l <10 <10 <10 <10 <10

Dibenzo(ah)anthracene <10 μg/ l <10 <10 <10 <10 <10

Benzo(ghi)perylene <10 μg/ l <10 <10 <10 <10 <10

Phthalates

Bis(2-ethylhexyl) phthalate <10 μg/ l <10 <10 <10 <10 <10

Butylbenzyl phthalate <10 μg/ l <10 <10 <10 <10 <10

Di-n-butyl phthalate <10 μg/ l <10 <10 <10 <10 <10

Di-n-Octyl phthalate <10 μg/ l <10 <10 <10 <10 <10

Diethyl phthalate <10 μg/ l <10 <10 <10 <10 <10

Dimethyl phthalate <10 μg/ l <10 <10 <10 <10 <10

Other SVOCs

1,2-Dichlorobenzene <10 μg/ l <10 <10 <10 <10 <10

1,2,4-Trichlorobenzene <10 μg/ l <10 <10 <10 <10 <10



2-Nitroaniline <10 μg/ l <10 <10 <10 <10 <10

2,4-Dinitrotoluene <10 μg/ l <10 <10 <10 <10 <10

2,6-Dinitrotoluene <10 μg/ l <10 <10 <10 <10 <10


4-Bromophenylphenylether <10 μg/ l <10 <10 <10 <10 <10

4-Chloroaniline <10 μg/ l <10 <10 <10 <10 <10

4-Chlorophenylphenylether <10 μg/ l <10 <10 <10 <10 <10


Azobenzene <10 μg/ l <10 <10 <10 <10 <10

Bis(2-chloroethoxy)methane <10 μg/ l <10 <10 <10 <10 <10

Bis(2-chloroethyl)ether <10 μg/ l <10 <10 <10 <10 <10

Carbazole <10 μg/ l <10 <10 <10 <10 <10

Dibenzofuran <10 μg/ l <10 <10 <10 <10 <10

Hexachlorobenzene <10 μg/ l <10 <10 <10 <10 <10

Hexachlorobutadiene <10 μg/ l <10 <10 <10 <10 <10

Hexachlorocyclopentadiene <10 μg/ l <10 <10 <10 <10 <10

Hexachloroethane <10 μg/ l <10 <10 <10 <10 <10

Isophorone <10 μg/ l <10 <10 <10 <10 <10

N-nitrosodi-n-propylamine <10 μg/ l <10 <10 <10 <10 <10

Nitrobenzene <10 μg/ l <10 <10 <10 <10 <10

SVOCs

LOD Units

Golder Associates Ireland

Town Centre House

Dublin Road

Naas

Co. Kildare

Ireland

T: +353 45 87 4411

March 2011


IPPC Biannual GroundwaterMonitoring September 2010

REPO

RT

Report Number. 10507140021.R2.A0

Distribution:

2 Copies Vistakon Johnson & Johnson

1 Copy - Golder Associates

Submitted to:

EHS ManagerVistakon Johnson & JohnsonNational Technological ParkCastletroyLimerick

BIANNUAL GROUNDWATER MONITORING SEPTEMBER 2010

March 2011Report No. 10507140021.R2.A0

Record of Issue

Company Client Contact Version Date IssuedMethod ofDelivery

Golder Associates Internal Review D.0 November 2010

Vistakon Johnson& Johnson

Margaret Stokes B.0 November 2010


Margaret Stokes B.1 January 2011


Margaret Stokes B.2 March 2011


Margaret Stokes A.0 March 2011

March 2011Report No. 10507140021.R2.A0 i

Table of Contents

1.0 INTRODUCTION........................................................................................................................................................ 1

2.0 SCOPE OF WORKS.................................................................................................................................................. 1

3.0 METHODOLOGY....................................................................................................................................................... 1

4.0 RESULTS .................................................................................................................................................................. 2

4.1 Groundwater Levels...................................................................................................................................... 2

4.2 Groundwater Sampling and Field Results .................................................................................................... 2

4.3 Results of Laboratory Analysis ..................................................................................................................... 2

4.4 Discussion of Laboratory Results ................................................................................................................. 5

4.5 Quality Assurance/Quality Control (QA/QC) ................................................................................................. 2

5.0 CONCLUSIONS AND RECOMMENDATIONS.......................................................................................................... 5

6.0 5

TABLES

Table 1: Groundwater Monitoring Well Water Levels and Depths....................................................................................... 2

Table 2: Field Parameter Measurements ............................................................................................................................ 2

Table 3: Results of Laboratory Analysis.............................................................................................................................. 4

APPENDICES

APPENDIX A

Figures

APPENDIX BGroundwater Monitoring Results - VOCs and SVOCs

APPENDIX CHistorical Groundwater Monitoring Results


March 2011Report No. 10507140021.R2.A0 1

1.0 INTRODUCTION

This report details the findings of biannual groundwater monitoring conducted in September 2010 at the

Vistakon Johnson & Johnson Plant. The plant is located at the National Technological Park, Castletroy, on

the outskirts of Limerick City (Figure 01).






2.0 SCOPE OF WORKS



■ Water level measurement (‘dip round’) indicating depth to groundwater in all wells;

■ Well purging to remove stagnant water from each well to ensure that a groundwater sample


■ Measurement of unstable water quality parameters (pH, temperature, electrical conductivity, redox


■ Collection of groundwater samples for laboratory analysis. Samples will be collected in laboratory



■ Completion of appropriate Chain of Custody (COC) documentation for sample traceability purposes

and dispatch of samples to the laboratory by overnight courier.

3.0 METHODOLOGY

Groundwater levels were measured in three of the four groundwater monitoring wells: GW1, GW2 and GW4.

GW3 is an abstraction well with water being used as part of the manufacturing process at the facility. This

well is likely to be subject to a cone of depression due to continuous abstraction. Groundwater level

monitoring was undertaken in all three wells using as a Solinst Water Level Meter and conducted in

accordance with Golder Associate’s (Golder’s) procedure for water level monitoring.




for laboratory analysis. A sampling tap leading from the rising main was used to retrieve the sample at GW3.

This was run for several minutes before filling the sampling containers.

Field parameters were measured during purging and sampling of the monitoring wells. A Hanna Multi-

parameter meter was used to measure field parameters. This was calibrated prior to undertaking the

sampling round.



Environmental Laboratories in the United Kingdom.



4.0 RESULTS


Groundwater levels recorded on the day of monitoring are tabulated in Table 1 below. Depths from the Top

of Casing (TOC) to water level were measured at the three locations. Figure 02 shows the locations of all

groundwater monitoring wells.

Table 1: Groundwater Monitoring Well Water Levels and Depths

Monitoring Well IDTOC Level Groundwater Level

mOD mBTOC mOD

GW1 13.03 3.63 9.40

GW2 11.24 4.29 6.95

GW3 10.10 - -

GW4 12.53 3.26 9.27


As stated above, field parameters were measured during purging and sampling of the groundwater

monitoring wells. These are tabulated in Table 2 below. Field parameters were all within the accepted

ranges of the EPA’s Interim Guideline Values (IGV’s).

Samples recovered from GW1 & GW2 were silty with sediment settling at the bottom of the containers once

recovered. GW3 & GW4 were relatively clear and free of silt. The sampling method employed would lead to

some disturbance of sediments, particularly in shallow overburden wells, giving a silty sample.

Table 2: Field Parameter Measurements

Monitoring Well IDpH Temperature Conductivity

(°C) (µS/cm)

GW1 7.3 9.5 771

GW2 7.2 9.2 866

GW3 7.5 11.3 695

GW4 7.6 9.4 756

4.3 Results of Laboratory Analysis

Results of analysis are tabulated in Table 3 and are compared to the EPA’s Interim Guideline Values (IGV)

with exceedances highlighted in red for identification purposes. All Volatile Organic Compound (VOC) and

Semi Volatile Organic Compound (SVOC) parameters analysed for were below laboratory Limits of Detection

(LODs). These are included in Appendix B located at the end of this report.

The recommended IGV for Chloride is 30 mg/L. This was exceeded in all four wells; GW1 (37.5 mg/L), GW2

(39.8 mg/L), GW3 (35.0 mg/L) and GW4 (34.9 mg/L). These were the only exceedances identified in this

monitoring round.

4.4 Quality Assurance/Quality Control (QA/QC)

In order to ascertain the sampling precision (i.e. repeatability or reproducibility) field duplicate samples were

collected. This entailed repeat sampling from the same location. Duplicate samples give a measure of

analytical and total sampling variance due to sampling, containers, storage and analysis. One duplicate

sample was collected in the field for this purpose from GW4 and sent to the laboratory for analysis.





between -6.19% and 5.30% for the five samples. An ionic balance of less than 10% is deemed acceptable

for laboratory data.

No significant difference was observed between the original and duplicate sample.

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4.5 Discussion of Laboratory Results

As mentioned above, all parameters were below the recommended guideline values for this monitoring

round except chloride which exceeded the recommended guideline value in all four monitoring wells.

Results of previous monitoring rounds for 2009 and 2010 are tabulated in Appendix C attached to this report.

When chloride levels are compared over the course of the four monitoring rounds, levels were elevated in

monitoring wells GW2 and GW3 on all occasions and above the recommended IGV level of 30 mg/L.

It can also be seen that levels in GW2 and GW3 fluctuated over this period but are decreasing slightly over

time.

Although chloride was above the recommended guideline value in the four monitoring wells for this round,

the levels are still relatively low with the highest level of 39.8mg/L recorded in GW2. S.I. No. 9 of 2010,

European Communities Environmental Objectives (Groundwater) Regulations, 2010 suggests a threshold

level of between 24 – 187.5 mg/L for chloride.

The Geological Survey of Ireland (GSI) has developed groundwater body descriptions for groundwater

bodies across Ireland. According to the Limerick City East GWB which the Site is located in, “background

chloride concentrations will be higher than in the Midlands, due to proximity to the sea” (GSI 2004).

Chloride originates from both natural, mainly rainfall, and anthropogenic sources, such as run-off containing

de-icing salts for road networks, the use of inorganic fertilizers, landfill leachates, septic tank effluents,

animal feeds, industrial and domestic effluents. It may also arise from seawater intrusion in coastal areas

(EPA 2005).

As part of their IPPC Licence, Vistakon are required to undertake inspections of all bunded tanks and areas

where waste is stored on-Site. Camera surveys of underground ducting are also undertaken to ensure the

integrity of underground services. No leaks or accidental emissions from tanks or service have been

reported to the EHS department.


Groundwater monitoring has been carried out by Golder biannually, as specified in the IPPC Licence. In the

most recent monitoring round, all parameters were below the recommended guideline value except chloride

in all four monitoring wells.

Fluctuating chloride concentrations have been observed in all monitoring wells at the Site for the last two

years. For the most part, no significant deterioration in water quality has been noted to date. Although the

levels exceed the recommended guideline value of 30mg/L, they are still relatively low and fall well short of

the recommended drinking water guideline value of 250mg/L. It is recommended that a regular review of the

data is undertaken to assess changes in groundwater quality overtime.

6.0 REFERENCES

Geological Survey of Ireland (GSI 2004) – Limerick City East GWB: Draft 2 5th

January 2004

http://www.gsi.ie/NR/rdonlyres/072CDD54-85AA-4393-A1B5-4E26ED86979F/0/Limerick.pdf.

Accessed March 2011.

Environmental Protection Agency (EPA 2005) - Water Quality in Ireland 2001 - 2003



APPENDIX AFigures

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Figure:



APPENDIX BGroundwater Monitoring Results - VOCs and SVOCs


Sample Date Units LOD 16/09/10 16/09/10 16/09/10 16/09/10 16/09/10

Phenols

2-Chlorophenol μg/ l <10 <10 <10 <10 <10 <10

2-Methylphenol μg/ l <10 <10 <10 <10 <10 <10

2-Nitrophenol μg/ l <10 <10 <10 <10 <10 <10

2,4-Dichlorophenol μg/ l <10 <10 <10 <10 <10 <10

2,4-Dimethylphenol μg/ l <10 <10 <10 <10 <10 <10

2,4,5-Trichlorophenol μg/ l <10 <10 <10 <10 <10 <10


4-Chloro-3-methylphenol μg/ l <10 <10 <10 <10 <10 <10


4-Nitrophenol μg/ l <10 <10 <10 <10 <10 <10

Pentachlorophenol μg/ l <10 <10 <10 <10 <10 <10

Phenol μg/ l <10 <10 <10 <10 <10 <10

PAHs

2-Chloronaphthalene μg/ l <10 <10 <10 <10 <10 <10

2-Methylnaphthalene μg/ l <10 <10 <10 <10 <10 <10

Naphthalene μg/ l <10 <10 <10 <10 <10 <10

Acenaphthylene μg/ l <10 <10 <10 <10 <10 <10

Acenaphthene μg/ l <10 <10 <10 <10 <10 <10

Fluorene μg/ l <10 <10 <10 <10 <10 <10

Phenanthrene μg/ l <10 <10 <10 <10 <10 <10

Anthracene μg/ l <10 <10 <10 <10 <10 <10

Fluoranthene μg/ l <10 <10 <10 <10 <10 <10

Pyrene μg/ l <10 <10 <10 <10 <10 <10

Benz(a)anthracene μg/ l <10 <10 <10 <10 <10 <10

Chrysene μg/ l <10 <10 <10 <10 <10 <10

Benzo(bk)fluoranthene μg/ l <10 <10 <10 <10 <10 <10

Benzo(a)pyrene μg/ l <10 <10 <10 <10 <10 <10

Indeno(123cd)pyrene μg/ l <10 <10 <10 <10 <10 <10

Dibenzo(ah)anthracene μg/ l <10 <10 <10 <10 <10 <10

Benzo(ghi)perylene μg/ l <10 <10 <10 <10 <10 <10

Phthalates

Bis(2-ethylhexyl) phthalate μg/ l <10 <10 <10 <10 <10 <10

Butylbenzyl phthalate μg/ l <10 <10 <10 <10 <10 <10

Di-n-butyl phthalate μg/ l <10 <10 <10 <10 <10 <10

Di-n-Octyl phthalate μg/ l <10 <10 <10 <10 <10 <10

Diethyl phthalate μg/ l <10 <10 <10 <10 <10 <10

Dimethyl phthalate μg/ l <10 <10 <10 <10 <10 <10

Other SVOCs

1,2-Dichlorobenzene μg/ l <10 <10 <10 <10 <10 <10

1,2,4-Trichlorobenzene μg/ l <10 <10 <10 <10 <10 <10



2-Nitroaniline μg/ l <10 <10 <10 <10 <10 <10

2,4-Dinitrotoluene μg/ l <10 <10 <10 <10 <10 <10



4-Bromophenylphenylether μg/ l <10 <10 <10 <10 <10 <10

4-Chloroaniline μg/ l <10 <10 <10 <10 <10 <10

4-Chlorophenylphenylether μg/ l <10 <10 <10 <10 <10 <10


Azobenzene μg/ l <10 <10 <10 <10 <10 <10

Bis(2-chloroethoxy)methane μg/ l <10 <10 <10 <10 <10 <10

Bis(2-chloroethyl)ether μg/ l <10 <10 <10 <10 <10 <10

Carbazole μg/ l <10 <10 <10 <10 <10 <10

Dibenzofuran μg/ l <10 <10 <10 <10 <10 <10

Hexachlorobenzene μg/ l <10 <10 <10 <10 <10 <10

Hexachlorobutadiene μg/ l <10 <10 <10 <10 <10 <10

Hexachlorocyclopentadiene μg/ l <10 <10 <10 <10 <10 <10

Hexachloroethane μg/ l <10 <10 <10 <10 <10 <10

Isophorone μg/ l <10 <10 <10 <10 <10 <10

N-nitrosodi-n-propylamine μg/ l <10 <10 <10 <10 <10 <10

Nitrobenzene μg/ l <10 <10 <10 <10 <10 <10

SVOC Results



Dichlorodifluoromethane μg/l <2 <2 <2 <2 <2 <2

Methyl Tertiary Butyl Ether μg/l <1 <1 <1 <1 <1 <1

Chloromethane# μg/l <3 <3 <3 <3 <3 <3

Vinyl Chloride μg/l <2 <2 <2 <2 <2 <2

Bromomethane μg/l <1 <1 <1 <1 <1 <1

Chloroethane# μg/l <3 <3 <3 <3 <3 <3

Trichlorofluoromethane# μg/l <3 <3 <3 <3 <3 <3

1,1-Dichloroethene# μg/l <3 <3 <3 <3 <3 <3

Carbon Disulphide# μg/l <3 NA NA NA NA NA

Dichloromethane# μg/l <3 <3 <3 <3 <3 <3

trans-1-2-Dichloroethene# μg/l <3 <3 <3 <3 <3 <3

1,1-Dichloroethane# μg/l <3 <3 <3 <3 <3 <3

cis-1-2-Dichloroethene# μg/l <3 <3 <3 <3 <3 <3

2,2-Dichloropropane μg/l <1 <1 <1 <1 <1 <1

Bromochloromethane# μg/l <2 <2 <2 <2 <2 <2

Chloroform# μg/l <2 <2 <2 <2 <2 <2

1,1,1-Trichloroethane# μg/l <2 <2 <2 <2 <2 <2

1,1-Dichloropropene# μg/l <3 <3 <3 <3 <3 <3

Carbon tetrachloride# μg/l <2 <2 <2 <2 <2 <2


Benzene# μg/l <1 <1 <1 <1 <1 <1

Trichloroethene# μg/l <3 <3 <3 <3 <3 <3

1,2-Dichloropropane# μg/l <2 <2 <2 <2 <2 <2

Dibromomethane# μg/l <3 <3 <3 <3 <3 <3

Bromodichloromethane# μg/l <2 <2 <2 <2 <2 <2

cis-1-3-Dichloropropene# μg/l <2 <2 <2 <2 <2 <2

Toluene# μg/l <2 <2 <2 <2 <2 <2

trans-1-3-Dichloropropene# μg/l <2 <2 <2 <2 <2 <2


Tetrachloroethene# μg/l <3 <3 <3 <3 <3 <3


Dibromochloromethane# μg/l <2 <2 <2 <2 <2 <2

1,2-Dibromoethane# μg/l <2 <2 <2 <2 <2 <2

Chlorobenzene# μg/l <2 <2 <2 <2 <2 <2

1,1,1,2-Tetrachloroethane# μg/l <2 <2 <2 <2 <2 <2

Ethylbenzene# μg/l <2 <2 <2 <2 <2 <2

p/m-Xylene# μg/l <3 <3 <3 <3 <3 <3

o-Xylene# μg/l <2 <2 <2 <2 <2 <2

Styrene# μg/l <2 <2 <2 <2 <2 <2

Bromoform# μg/l <2 <2 <2 <2 <2 <2

Isopropylbenzene# μg/l <3 <3 <3 <3 <3 <3

1,1,2,2-Tetrachloroethane μg/l <4 <4 <4 <4 <4 <4

Bromobenzene# μg/l <2 <2 <2 <2 <2 <2

1,2,3-Trichloropropane# μg/l <3 <3 <3 <3 <3 <3

Propylbenzene# μg/l <3 <3 <3 <3 <3 <3

2-Chlorotoluene# μg/l <3 <3 <3 <3 <3 <3

1,3,5-Trimethylbenzene# μg/l <3 <3 <3 <3 <3 <3


tert-Butylbenzene# μg/l <3 <3 <3 <3 <3 <3


sec-Butylbenzene# μg/l <3 <3 <3 <3 <3 <3

4-Isopropyltoluene# μg/l <3 <3 <3 <3 <3 <3

1,3-Dichlorobenzene# μg/l <3 <3 <3 <3 <3 <3


n-Butylbenzene# μg/l <3 <3 <3 <3 <3 <3


1,2-Dibromo-3-chloropropane μg/l <2 <2 <2 <2 <2 <2

1,2,4-Trichlorobenzene μg/l <3 <3 <3 <3 <3 <3

Hexachlorobutadiene# μg/l <3 <3 <3 <3 <3 <3

Naphthalene μg/l <2 <2 <2 <2 <2 <2


VOC Results

Para

met

erN

ame

Uni

tsEP

A

Lab

IDIG

V's

25/0

6/09

26/1

1/09

09/0

2/10

16/0

9/10

25/0

6/09

26/1

1/09

09/0

2/10

16/0

9/10

25/0

6/09

26/1

1/09

09/0

2/10

16/0

9/10

25/0

6/09

26/1

1/09

09/0

2/10

16/0

9/10

pHpH

Units

≥6.5

and≤9

.57.

27.

637.

427.

797.

57.

277.

277.

467.

27.

847.

867.

987.

17.

377.

477.

91

Cond

uctiv

ityus

cm-1

@25

C10

0078

668

672

579

310

2475

593

587

976

052

282

072

480

564

777

178

7

Diss

olve

dO

xyge

nm

g/L

-7.

08.

09.

09.

09.

97.

09.

04.

06.

210

.07.

03.

07.

18.

03.

04.

0

COD

mg/

L-

67.

00<7

<78

12.0

07.

0011

.00

<5<7

<7<7

<5<7

<7<7

Tota

lSus

pend

edSo

lids

mg/

L-

9853

1996

1128

950

5737

568

<2<1

013

1647

<10

<10

6

Sodi

umm

g/L

150

9.07

9.69

10.9

419

.90

17.0

516

.76

22.7

120

.20

12.6

319

.23

25.0

019

.90

10.3

89.

3213

.63

18.6

0

Pota

ssiu

mm

g/L

51.

302.

251.

901.

601.

492.

591.

901.

400.

963.

611.

241.

201.

461.

221.

411.

70

Mag

nesiu

mm

g/L

509.

227.

7012

.32

15.4

012

.64

8.70

31.8

117

.10

15.2

18.

7819

.39

19.7

09.

879.

3612

.25

14.4

0

Calci

umm

g/L

200

135.

0094

.82

138.

6012

3.50

172.

1011

2.80

145.

3016

1.70

120.

0062

.50

118.

2010

9.60

106.

3098

.68

131.

4013

9.50

Amm

onia

mg/

LasN

0.15

50.

01<0

.23

<0.2

3<0

.23

0.01

<0.2

3<0

.23

<0.2

30.

01<0

.23

<0.2

3<0

.23

<0.0

1<0

.23

<0.2

3<0

.23

Amm

onia

mg/

LasN

H4

0.01

<0.3

<0.3

<0.3

0.01

<0.3

<0.3

<0.3

0.01

<0.3

<0.3

<0.3

<0.0

1<0

.3<0

.3<0

.3

Fluo

ride

mg/

L1

0.32

<0.3

<0.3

<0.3

0.27

<0.3

<0.3

<0.3

0.22

<0.3

<0.3

<0.3

0.24

<0.3

<0.3

<0.3

Chlo

ride

mg/

L30

26.5

720

.24

22.4

437

.50

50.6

134

.58

45.0

739

.84

32.5

636

.83

46.6

135

.03

29.0

020

.53

28.1

734

.94

Cyan

ide

ug/L

10<5

<40

<40

<40

<5<4

0<4

0<4

07.

00<4

0<4

0<4

04.

00<4

0<4

0<4

0

Phos

phat

e(O

rtho

)m

g/La

sP-

<0.0

05<0

.019

<0.0

1<0

.019

<0.0

05<0

.019

<0.0

1<0

.019

0.07

7<0

.019

<0.0

1<0

.019

<0.0

05<0

.019

<0.0

1<0

.019

Phos

phat

e(O

rtho

)m

g/La

sPO

43-0.

03<0

.015

<0.0

6<0

.03

<0.0

6<0

.015

<0.0

6<0

.03

<0.0

60.

24<0

.06

<0.0

3<0

.06

<0.0

15<0

.06

<0.0

3<0

.06

Nitr

item

g/La

sN-

<0.0

030.

02<0

.006

<0.0

06<0

.003

<0.0

061

<0.0

06<0

.006

<0.0

030.

02<0

.006

<0.0

06<0

.003

0.02

<0.0

06<0

.006

Nitr

item

g/La

sN0 2

-0.

1<0

.009

80.

05<0

.02

<0.0

2<0

.009

8<0

.02

<0.0

2<0

.02

<0.0

098

0.06

<0.0

2<0

.02

<0.0

098

0.05

<0.0

2<0

.02

Nitr

ate

mg/

LasN

-0.

850.

750.

160.

950.

111.

780.

540.

232.

071.

180.

321.

290.

991.

130.

251.

13

Nitr

ate

mg/

LasN

0 32-

253.

763.

280.

654.

200.

497.

912.

360.

979.

165.

191.

385.

704.

385.

011.

055.

02

Tota

lAlk

alin

itym

g/L

CaCO

3-

302

346

352

354

351

390

400

462

308

239

340

333

311

298

376

377

sVO

Csug

/L-

--

--

--

--

--

--

--

-

Sulp

hate

mg/

LasS

O4

200

26.0

316

.57

22.9

448

.16

50.2

722

.18

29.8

166

.01

23.2

427

.45

22.9

620

.68

28.2

714

.34

22.0

437

.94

VOCs

ug/L

--

--

--

--

--

--

--

--

GW1

GW3

GW2

GW4

Golder Associates Ireland Limited

Town Centre House

Dublin Road

Naas

Co. Kildare

Ireland

T: +353 45 87 4411

GROUNDWATER MONITORING DECEMBER 2010


Record of Issue

Company Client Contact Version Date IssuedMethod ofDelivery

Golder Associates Internal Review D.0 January 2010


Margaret Stokes B.0 January 2010


Margaret Stokes A.0 March 2010

March 2011Report No. 10507140021.R3.A0 i

Table of Contents

MARCH 2011...................................................................................................................................................................... 1

1.0 INTRODUCTION........................................................................................................................................................ 1

2.0 SCOPE OF WORKS.................................................................................................................................................. 1

3.0 METHODOLOGY....................................................................................................................................................... 1

4.0 RESULTS .................................................................................................................................................................. 2

4.1 Groundwater Levels...................................................................................................................................... 2

4.2 Groundwater Sampling and Field Results .................................................................................................... 2

4.3 Results of Laboratory Analysis ..................................................................................................................... 2

4.4 Quality Assurance/Quality Control (QA/QC) ................................................................................................. 2

4.5 Discussion of Laboratory Results ................................................................................................................. 5

5.0 CONCLUSIONS AND RECOMMENDATIONS.......................................................................................................... 5

6.0 REFERENCES........................................................................................................................................................... 5

TABLES

Table 1: Groundwater Monitoring Well Water Levels and Depths....................................................................................... 2

Table 2: Field Parameter Measurements ............................................................................................................................ 2

Table 3: Results of Laboratory Analysis.............................................................................................................................. 4

APPENDICES

APPENDIX A

Site Maps

APPENDIX BGroundwater Monitoring Results - SVOCs and VOCs




1.0 INTRODUCTION

This report details the findings of groundwater monitoring conducted in December 2010 at the Vistakon

Johnson & Johnson Plant. The plant is located at the National Technological Park, Castletroy, on the

outskirts of Limerick City (Figure 01).






2.0 SCOPE OF WORKS



Water level measurement (‘dip round’) indicating depth to groundwater in all wells;

Well purging to remove stagnant water from each well to ensure that a groundwater sample


Measurement of unstable water quality parameters (pH, temperature, electrical conductivity, redox


Collection of groundwater samples for laboratory analysis. Samples will be collected in laboratory



Completion of appropriate Chain of Custody (COC) documentation for sample traceability purposes and

dispatch of samples to the laboratory by overnight courier.

3.0 METHODOLOGY

Groundwater levels were measured in all four groundwater monitoring wells: GW1, GW2, GW3 and GW4.

Groundwater level monitoring was undertaken using as a Solinst Water Level Meter and conducted in

accordance with Golder Associate’s (Golder’s) procedure for water level monitoring. GW3 is an abstraction

well with water being used as part of the manufacturing process at the Facility. This well is likely to be

subject to a cone of depression due to continuous abstraction.




for laboratory analysis. In a recent monitoring round a dedicated bailer was installed in GW2 as it was

difficult to retrieve a water sample using the Waterra tubing due to the low water level in the monitoring well.

A sampling tap leading from the rising main was used to retrieve the sample at GW3. This was run for

several minutes before filling the sampling containers.

Field parameters were measured during purging and sampling of the monitoring wells. A Hanna Multi-

parameter meter was used to measure field parameters. This was calibrated prior to undertaking the

sampling round.



Environmental Laboratories in the United Kingdom within 24 hours.



4.0 RESULTS


Groundwater levels recorded on the day of monitoring are tabulated in Table 1 below. Depths from the Top

of Casing (TOC) to water level were measured at the three locations. Figure 02 shows the locations of all

groundwater monitoring wells. As stated previously, GW3 is an abstraction well with water being abstracted

on a continuous basis and used as part of the manufacturing process at the Facility. Measured groundwater

levels taken on the day of monitoring show that abstraction from this well creates a cone of depression. This

would lead to groundwater in the vicinity being drawn to this location.

Table 1: Groundwater Monitoring Well Water Levels and Depths

Monitoring Well IDTOC Level Groundwater Level

mOD mBTOC mOD

GW1 13.03 2.67 10.36

GW2 11.24 4.17 7.07

GW3 10.10 11.08 -0.98

GW4 12.53 2.08 10.45


As stated above, field parameters were measured during purging and sampling of the groundwater

monitoring wells. These are tabulated in Table 2 below. Field parameters were all within the accepted

ranges of the EPA’s Interim Guideline Values (IGV’s).

Samples recovered from GW1 & GW2 were very silty with sediment settling at the bottom of the containers

once recovered. GW3 & GW4 were relatively clear and free of silt. The sampling method employed would

lead to some disturbance of sediments, particularly in shallow overburden wells, giving a silty sample.

Table 2: Field Parameter Measurements

Monitoring Well IDpH Temperature Conductivity

(°C) (µS/cm)

GW1 7.1 8.1 779

GW2 6.8 8.4 965

GW3 7.2 9.1 705

GW4 7.3 8.9 690

4.3 Results of Laboratory Analysis

Results of analysis are tabulated in Table 3 and are compared to the EPA’s Interim Guideline Values (IGV)

with exceedances highlighted in red for identification purposes. All Volatile Organic Compound (VOC) and

Semi Volatile Organic Compound (SVOC) parameters analysed for were below laboratory Limits of Detection

(LODs). These are included in Appendix B located at the end of this report.

The recommended IGV for Chloride is 30mg/L. This was exceeded in two of the four monitoring wells; GW2

(44.3 mg/L) and GW3 (41.6 mg/L). These were the only exceedances identified in this monitoring round.

4.4 Quality Assurance/Quality Control (QA/QC)

In order to ascertain the sampling precision (i.e. repeatability or reproducibility) field duplicate samples were

collected. This entailed repeat sampling from the same location. Duplicate samples give a measure of

analytical and total sampling variance due to sampling, containers, storage and analysis. One duplicate

sample was collected from GW1 for this purpose and sent to the laboratory for analysis.





between -5.06% and 0.72% for the five samples. An ionic balance of less than 10% is deemed acceptable

for laboratory data.

No significant difference in the laboratory results was observed between the original and duplicate sample.

GR

OU

ND

WA

TE

RM

ON

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GD

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010

Marc

h2011

Rep

ort

No

.10507140021.R

3.A

04

Tab

le3:

Resu

lts

of

Lab

ora

tory

An

aly

sis

Sa

mp

leID

Un

itIG

VV

alu

eG

W1

GW

1D

GW

2G

W3

GW

4

pH

pH

Un

its

≥6.5

and≤9

.56

.90

6.9

66

.72

7.0

47

.10

Ele

ctr

icalC

ond

uctivity

µS

/cm

10

00

82

87

42

98

67

52

71

0

Dis

solv

ed

Oxyg

en

mg

/L-

98

57

6

Re

do

xP

ote

ntia

lm

/v-

30

49

84

11

31

06

CO

Dm

g/L

-<

7<

7<

7<

7<

7

To

talS

uspe

nde

dS

olid

sm

g/L

-1

44

29

56

11

17

<1

0<

10

So

diu

m-

dis

so

lve

dm

g/L

15

01

1.2

10

.61

7.6

18

.91

2.5

Po

tassiu

m-

dis

so

lve

dm

g/L

51

.91

.91

.81

.31

.5

Ma

gn

esiu

m-

dis

so

lve

dm

g/L

50

12

.11

1.9

15

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8.6

11

.0

Ca

lciu

m-

dis

solv

ed

mg

/L2

00

13

6.4

13

3.9

17

6.5

11

5.1

12

8.0

Am

mon

iam

g/L

as

N0

.15

50

.15

0.1

50

.15

<0

.15

<0

.15

Am

mon

iam

g/L

as

NH

4-

0.2

0.2

0.2

<0

.2<

0.2

Flu

orid

em

g/L

1<

0.3

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Ch

lori

de

mg

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6.4

26

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41

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lph

ate

mg

/La

sS

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20

03

1.1

23

2.2

66

0.7

82

3.3

22

3.9

2

To

talC

ya

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10

<1

0<

10

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0<

10

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0

Ph

osph

ate

(Ort

ho

)m

g/L

as

P-

<0

.01

9<

0.0

19

<0

.01

9<

0.0

19

<0

.01

9

Ph

osph

ate

(Ort

ho

)m

g/L

as

PO

43-

0.0

3<

0.0

6<

0.0

6<

0.0

6<

0.0

6<

0.0

6

Nitri

tem

g/L

as

N-

<0

.00

6<

0.0

06

<0

.00

6<

0.0

06

<0

.00

6

Nitri

tem

g/L

as

NO

2-

0.1

<0

.02

<0

.02

<0

.02

<0

.02

<0

.02

Nitra

tem

g/L

as

N-

0.7

50

.86

0.9

31

.65

1.2

0

Nitra

tem

g/L

as

NO

32-

25

3.3

3.8

4.1

7.3

5.3

To

talA

lka

linity

mg

/LC

aC

O3

-3

69

37

84

87

36

03

64

VO

Cs

µg

/L-

Ap

pe

ndix

B

SV

OC

sµ

g/L

-A

pp

en

dix

B



4.5 Discussion of Laboratory Results

As mentioned above, all parameters were below the recommended guideline values for this monitoring

round except chloride which exceeded the recommended guideline value in two out of the four monitoring

wells (GW2 & GW3). Results of previous monitoring rounds for 2009 and 2010 are tabulated in Appendix C

attached to this report. When chloride levels are compared over the course of the five monitoring rounds,

levels were elevated in monitoring wells GW2 and GW3 on all occasions and above the recommended IGV

level of 30 mg/L.

It can also be seen that levels in GW2 and GW3 fluctuated over this period but are decreasing slightly over

time.

Although chloride was above the recommended guideline value in the two monitoring wells for this round, the

levels are still relatively low with the highest level of 44.3 mg/L recorded in GW2. S.I. No. 9 of 2010,

European Communities Environmental Objectives (Groundwater) Regulations, 2010 suggests a threshold

level of between 24 – 187.5 mg/L for chloride.

The Geological Survey of Ireland (GSI) has developed groundwater body descriptions for groundwater

bodies across Ireland. According to the Limerick City East GWB which the Site is located in, “background

chloride concentrations will be higher than in the Midlands, due to proximity to the sea” (GSI 2004).

Chloride originates from both natural, mainly rainfall, and anthropogenic sources, such as run-off containing

de-icing salts for road networks, the use of inorganic fertilizers, landfill leachates, septic tank effluents,

animal feeds, industrial and domestic effluents. It may also arise from seawater intrusion in coastal areas

(EPA 2005).

As part of their IPPC Licence, Vistakon are required to undertake inspections of all bunded tanks and areas

where waste is stored on-Site. Camera surveys of underground ducting are also undertaken to ensure the

integrity of underground services. No leaks or accidental emissions from tanks or service have been

reported to the EHS department.


Groundwater monitoring has been carried out by Golder, as specified in the IPPC Licence. In the most

recent monitoring round, all parameters were below the recommended guideline values except chloride

which exceeded the recommended IGV level of 30 mg/L in GW2 and GW3.

Fluctuating chloride concentrations have been observed in all monitoring wells at the Site for the last two

years. For the most part, no significant deterioration in water quality has been noted to date. Although the

levels exceed the recommended guideline value of 30mg/L, they are still relatively low and fall well short of

the recommended drinking water guideline value of 250mg/L. It is recommended that a regular review of the

data is undertaken to assess changes in groundwater quality overtime.

6.0 REFERENCES

Geological Survey of Ireland (GSI 2004) – Limerick City East GWB: Draft 2 5th

January 2004

http://www.gsi.ie/NR/rdonlyres/072CDD54-85AA-4393-A1B5-4E26ED86979F/0/Limerick.pdf.

Accessed March 2011.

Environmental Protection Agency (EPA 2005) - Water Quality in Ireland 2001 - 2003

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APPENDIX BGroundwater Monitoring Results - SVOCs and VOCs

Sample ID GW1 GW1/D GW2 GW3 GW4


Phenols

2-Chlorophenol μg/ l <10 <10 <10 <10 <10 <10


2-Nitrophenol μg/ l <10 <10 <10 <10 <10 <10

2,4-Dichlorophenol μg/ l <10 <10 <10 <10 <10 <10

2,4-Dimethylphenol μg/ l <10 <10 <10 <10 <10 <10



4-Chloro-3-methylphenol μg/ l <10 <10 <10 <10 <10 <10


4-Nitrophenol μg/ l <10 <10 <10 <10 <10 <10

Pentachlorophenol μg/ l <10 <10 <10 <10 <10 <10

Phenol μg/ l <10 <10 <10 <10 <10 <10

PAHs

2-Chloronaphthalene μg/ l <10 <10 <10 <10 <10 <10

2-Methylnaphthalene μg/ l <10 <10 <10 <10 <10 <10

Naphthalene μg/ l <10 <10 <10 <10 <10 <10

Acenaphthylene μg/ l <10 <10 <10 <10 <10 <10

Acenaphthene μg/ l <10 <10 <10 <10 <10 <10

Fluorene μg/ l <10 <10 <10 <10 <10 <10

Phenanthrene μg/ l <10 <10 <10 <10 <10 <10

Anthracene μg/ l <10 <10 <10 <10 <10 <10

Fluoranthene μg/ l <10 <10 <10 <10 <10 <10

Pyrene μg/ l <10 <10 <10 <10 <10 <10

Benz(a)anthracene μg/ l <10 <10 <10 <10 <10 <10

Chrysene μg/ l <10 <10 <10 <10 <10 <10

Benzo(bk)fluoranthene μg/ l <10 <10 <10 <10 <10 <10

Benzo(a)pyrene μg/ l <10 <10 <10 <10 <10 <10

Indeno(123cd)pyrene μg/ l <10 <10 <10 <10 <10 <10

Dibenzo(ah)anthracene μg/ l <10 <10 <10 <10 <10 <10

Benzo(ghi)perylene μg/ l <10 <10 <10 <10 <10 <10

Phthalates

Bis(2-ethylhexyl) phthalate μg/ l <10 <10 <10 <10 <10 <10

Butylbenzyl phthalate μg/ l <10 <10 <10 <10 <10 <10

Di-n-butyl phthalate μg/ l <10 <10 <10 <10 <10 <10

Di-n-Octyl phthalate μg/ l <10 <10 <10 <10 <10 <10

Diethyl phthalate μg/ l <10 <10 <10 <10 <10 <10

Dimethyl phthalate μg/ l <10 <10 <10 <10 <10 <10

Other SVOCs


1,2,4-Trichlorobenzene μg/ l <10 <10 <10 <10 <10 <10







4-Bromophenylphenylether μg/ l <10 <10 <10 <10 <10 <10

4-Chloroaniline μg/ l <10 <10 <10 <10 <10 <10

4-Chlorophenylphenylether μg/ l <10 <10 <10 <10 <10 <10


Azobenzene μg/ l <10 <10 <10 <10 <10 <10

Bis(2-chloroethoxy)methane μg/ l <10 <10 <10 <10 <10 <10

Bis(2-chloroethyl)ether μg/ l <10 <10 <10 <10 <10 <10

Carbazole μg/ l <10 <10 <10 <10 <10 <10

Dibenzofuran μg/ l <10 <10 <10 <10 <10 <10

Hexachlorobenzene μg/ l <10 <10 <10 <10 <10 <10

Hexachlorobutadiene μg/ l <10 <10 <10 <10 <10 <10

Hexachlorocyclopentadiene μg/ l <10 <10 <10 <10 <10 <10

Hexachloroethane μg/ l <10 <10 <10 <10 <10 <10

Isophorone μg/ l <10 <10 <10 <10 <10 <10

N-nitrosodi-n-propylamine μg/ l <10 <10 <10 <10 <10 <10

Nitrobenzene μg/ l <10 <10 <10 <10 <10 <10

SVOC Results

Sample ID GW1 GW1/D GW2 GW3 GW4


Dichlorodifluoromethane μg/l <2 <2 <2 <2 <2 <2

Methyl Tertiary Butyl Ether μg/l <1 <1 <1 <1 <1 <1

Chloromethane# μg/l <3 <3 <3 <3 <3 <3

Vinyl Chloride μg/l <2 <2 <2 <2 <2 <2

Bromomethane μg/l <1 <1 <1 <1 <1 <1

Chloroethane# μg/l <3 <3 <3 <3 <3 <3

Trichlorofluoromethane# μg/l <3 <3 <3 <3 <3 <3

1,1-Dichloroethene# μg/l <3 <3 <3 <3 <3 <3

Carbon Disulphide# μg/l <3 NA NA NA NA NA

Dichloromethane# μg/l <3 <3 <3 <3 <3 <3

trans-1-2-Dichloroethene# μg/l <3 <3 <3 <3 <3 <3


cis-1-2-Dichloroethene# μg/l <3 <3 <3 <3 <3 <3

2,2-Dichloropropane μg/l <1 <1 <1 <1 <1 <1

Bromochloromethane# μg/l <2 <2 <2 <2 <2 <2

Chloroform# μg/l <2 <2 <2 <2 <2 <2


1,1-Dichloropropene# μg/l <3 <3 <3 <3 <3 <3

Carbon tetrachloride# μg/l <2 <2 <2 <2 <2 <2


Benzene# μg/l <1 <1 <1 <1 <1 <1

Trichloroethene# μg/l <3 <3 <3 <3 <3 <3


Dibromomethane# μg/l <3 <3 <3 <3 <3 <3

Bromodichloromethane# μg/l <2 <2 <2 <2 <2 <2

cis-1-3-Dichloropropene# μg/l <2 <2 <2 <2 <2 <2

Toluene# μg/l <2 <2 <2 <2 <2 <2

trans-1-3-Dichloropropene# μg/l <2 <2 <2 <2 <2 <2


Tetrachloroethene# μg/l <3 <3 <3 <3 <3 <3


Dibromochloromethane# μg/l <2 <2 <2 <2 <2 <2

1,2-Dibromoethane# μg/l <2 <2 <2 <2 <2 <2

Chlorobenzene# μg/l <2 <2 <2 <2 <2 <2

1,1,1,2-Tetrachloroethane# μg/l <2 <2 <2 <2 <2 <2

Ethylbenzene# μg/l <2 <2 <2 <2 <2 <2

p/m-Xylene# μg/l <3 <3 <3 <3 <3 <3

o-Xylene# μg/l <2 <2 <2 <2 <2 <2

Styrene# μg/l <2 <2 <2 <2 <2 <2

Bromoform# μg/l <2 <2 <2 <2 <2 <2

Isopropylbenzene# μg/l <3 <3 <3 <3 <3 <3

1,1,2,2-Tetrachloroethane μg/l <4 <4 <4 <4 <4 <4

Bromobenzene# μg/l <2 <2 <2 <2 <2 <2

1,2,3-Trichloropropane# μg/l <3 <3 <3 <3 <3 <3

Propylbenzene# μg/l <3 <3 <3 <3 <3 <3




tert-Butylbenzene# μg/l <3 <3 <3 <3 <3 <3


sec-Butylbenzene# μg/l <3 <3 <3 <3 <3 <3

4-Isopropyltoluene# μg/l <3 <3 <3 <3 <3 <3



n-Butylbenzene# μg/l <3 <3 <3 <3 <3 <3


1,2-Dibromo-3-chloropropane μg/l <2 <2 <2 <2 <2 <2


Hexachlorobutadiene# μg/l <3 <3 <3 <3 <3 <3

Naphthalene μg/l <2 <2 <2 <2 <2 <2


VOC Results

Para

met

erN

ame

Uni

tsEP

A

Lab

IDIG

V's

25/0

6/09

26/1

1/09

09/0

2/10

16/0

9/10

07/1

2/10

25/0

6/09

26/1

1/09

09/0

2/10

16/0

9/10

07/1

2/10

25/0

6/09

26/1

1/09

09/0

2/10

16/0

9/10

07/1

2/10

25/0

6/09

26/1

1/09

09/0

2/10

16/0

9/10

07/1

2/10

pHpH

Uni

ts≥6

.5an

d≤9

.57.

27.

637.

427.

796.

907.

57.

277.

277.

466.

727.

27.

847.

867.

987.

047.

17.

377.

477.

917.

10

Cond

uctiv

ityus

cm-1

@25

C10

0078

668

672

579

382

810

2475

593

587

998

676

052

282

072

475

280

564

777

178

771

0

Diss

olve

dO

xyge

nm

g/L

-7.

08.

09.

09.

09.

09.

97.

09.

04.

05.

06.

210

.07.

03.

07.

07.

18.

03.

04.

06.

0

COD

mg/

L-

67.

00<7

<7<7

812

.00

7.00

11.0

0<7

<5<7

<7<7

<7<5

<7<7

<7<7

Tota

lSus

pend

edSo

lids

mg/

L-

9853

1996

1114

4228

950

5737

568

1117

<2<1

013

16<1

047

<10

<10

6<1

0

Sodi

umm

g/L

150

9.07

9.69

10.9

419

.90

11.2

17.0

516

.76

22.7

120

.20

17.6

12.6

319

.23

25.0

019

.90

18.9

10.3

89.

3213

.63

18.6

012

.5

Pota

ssiu

mm

g/L

51.

302.

251.

901.

601.

901.

492.

591.

901.

401.

80.

963.

611.

241.

201.

301.

461.

221.

411.

701.

5

Mag

nesiu

mm

g/L

509.

227.

7012

.32

15.4

012

.112

.64

8.70

31.8

117

.10

15.2

15.2

18.

7819

.39

19.7

018

.69.

879.

3612

.25

14.4

011

.0

Calc

ium

mg/

L20

013

5.00

94.8

213

8.60

123.

5013

6.4

172.

1011

2.80

145.

3016

1.70

176.

512

0.00

62.5

011

8.20

109.

6011

5.1

106.

3098

.68

131.

4013

9.50

128.

0

Amm

onia

mg/

Las

N0.

155

0.01

<0.2

3<0

.23

<0.2

30.

150.

01<0

.23

<0.2

3<0

.23

0.15

0.01

<0.2

3<0

.23

<0.2

3<0

.15

<0.0

1<0

.23

<0.2

3<0

.23

<0.1

5

Amm

onia

mg/

Las

NH 4

0.01

<0.3

<0.3

<0.3

0.2

0.01

<0.3

<0.3

<0.3

0.2

0.01

<0.3

<0.3

<0.3

<0.2

<0.0

1<0

.3<0

.3<0

.3<0

.2

Fluo

ride

mg/

L1

0.32

<0.3

<0.3

<0.3

<0.3

0.27

<0.3

<0.3

<0.3

<0.3

0.22

<0.3

<0.3

<0.3

<0.3

0.24

<0.3

<0.3

<0.3

<0.3

Chlo

ride

mg/

L30

26.5

720

.24

22.4

437

.50

26.4

050

.61

34.5

845

.07

39.8

444

.27

32.5

636

.83

46.6

135

.03

41.6

529

.00

20.5

328

.17

34.9

427

.34

Sulp

hate

mg/

Las

SO4

200

26.0

316

.57

22.9

448

.16

31.1

250

.27

22.1

829

.81

66.0

160

.78

23.2

427

.45

22.9

620

.68

23.3

228

.27

14.3

422

.04

37.9

423

.92

Cyan

ide

ug/L

10<5

<40

<40

<10

<10

<5<4

0<4

0<1

0<1

07.

00<4

0<4

0<1

0<1

04.

00<4

0<4

0<1

0<1

0

Phos

phat

e(O

rtho

)m

g/L

asP

-<0

.005

<0.0

19<0

.01

<0.0

19<0

.019

<0.0

05<0

.019

<0.0

1<0

.019

<0.0

190.

077

<0.0

19<0

.01

<0.0

19<0

.019

<0.0

05<0

.019

<0.0

1<0

.019

<0.0

19

Phos

phat

e(O

rtho

)m

g/L

asPO

43-0.

03<0

.015

<0.0

6<0

.03

<0.0

6<0

.06

<0.0

15<0

.06

<0.0

3<0

.06

<0.0

60.

24<0

.06

<0.0

3<0

.06

<0.0

6<0

.015

<0.0

6<0

.03

<0.0

6<0

.06

Nitr

item

g/L

asN

-<0

.003

0.02

<0.0

06<0

.006

<0.0

06<0

.003

<0.0

061

<0.0

06<0

.006

<0.0

06<0

.003

0.02

<0.0

06<0

.006

<0.0

06<0

.003

0.02

<0.0

06<0

.006

<0.0

06

Nitr

item

g/L

asN

0 2-

0.1

<0.0

098

0.05

<0.0

2<0

.02

<0.0

2<0

.009

8<0

.02

<0.0

2<0

.02

<0.0

2<0

.009

80.

06<0

.02

<0.0

2<0

.02

<0.0

098

0.05

<0.0

2<0

.02

<0.0

2

Nitr

ate

mg/

Las

N-

0.85

0.75

0.16

0.95

0.75

0.11

1.78

0.54

0.23

0.93

2.07

1.18

0.32

1.29

1.65

0.99

1.13

0.25

1.13

1.20

Nitr

ate

mg/

Las

N0 3

2-25

3.76

3.28

0.65

4.20

3.3

0.49

7.91

2.36

0.97

4.1

9.16

5.19

1.38

5.70

7.3

4.38

5.01

1.05

5.02

5.3

Tota

lAlk

alin

itym

g/L

CaCO

3-

302

346

352

354

369

351

390

400

462

487

308

239

340

333

360

311

298

376

377

364

sVO

Csug

/L-

--

--

--

--

--

--

--

--

--

--

VOCs

ug/L

--

--

--

--

--

--

--

--

--

--

-

GW

1G

W2

GW

3G

W4

Golder Associates Ireland Limited

Town Centre House

Dublin Road

Naas

Co. Kildare

Ireland

T: +353 45 87 4411


AER Attachment No. 9: Solvent Management Plan

Vistakon Ireland Ltd IPPC Licence Compliance

Solvent Management Plan AER 2010 Revision 0

Contents

1. Introduction

2. Solvent Emissions Directive 2.1 Introduction 2.2 Compliance 2.3 Vistakon Compliance Thresholds

3. Vistakon Solvent Management Plan 3.1 Introduction 3.2 Methodology 3.3 Compliance Verification

4. Conclusion

1. INTRODUCTION Vistakon Ireland Ltd, have prepared a Solvent Management Plan (SMP) to fulfil Condition 6.19 of the Integrated Pollution Prevention Control (IPPC) Licence (Register No. 818) The condition is as follows: ‘The licensee shall prepare and report a Solvent Management Plan for the site for each calendar year. The organic solvents to be included in the SMP shall be determined by reference to the definition of an organic solvent in Council Directive 1999/13IEC. The SMP shall be prepared in accordance with any relevant guidelines in Annex I11 of the Directive or as issued by the Agency and shall be submitted as part of the AER. The licensee shall keep records of the data from which the reported information was derived and supporting documentation including a description of the methodology used for data collection.’ This report details the following:

• Background to the Solvents Directive and related Regulations

• Compliance Requirements

• Vistakon’s Solvent Management Plan

2. SOLVENT EMISSIONS DIRECTIVE

2.1 Introduction The European Council Directive (Limitation of Emissions of Volatile Organic Compounds due to the Use of Organic Solvents in Certain Activities and Installations) 1999/13/EEC has been implemented in Ireland by the Emissions of Volatile Organic Compounds from Organic Solvents Regulations (S.I. No. 543 of 2002).

The Regulations aim to prevent or reduce direct and indirect effects of emissions of volatile organic compounds (VOCs) into the environment and the potential risks to human health by providing measures and procedures to be implemented for specified activities and also to phase out the use of more harmful solvents such as carcinogens, mutagens and those toxic to reproduction. The First Schedule of these Regulations requires that coating activities be subject to compliance with the Regulations. Under the Second Schedule of the Regulations the activity defined as “Other Coating including metal, plastic, textile” (i.e. Activity number 8) detail the solvent consumption thresholds under which Vistakon must comply.

2.2 Compliance Requirements An installation or activity operating above the solvent consumption threshold will need to either:

• Meet an emission limit value (Schedule 2) in waste gases (mg C/Nm3) and a fugitive emission limit value (percentage of solvent use); or

• Implement a solvent reduction scheme1 (Schedule 3) to reduce emissions from the installation equal to those that would be achieved by meeting the total emission value.

1Note: The reduction scheme cannot be used for certain R‐phase compounds The dates by which the company needs to meet the requirements of the Regulations depend on whether it is a new or existing installation and whether it is meeting ‘Emission Limit Values’ or complying with a ‘Reduction Scheme’. A ‘new’ installation is one put into operation on or after 1 July 2003. An ‘existing’ installation is in operation on or before 30 June 2003. As Vistakon has been in operation since before the commencement date of the Directive, it is considered an ‘Existing’ installation.

2.2.1 Solvent Management Plan To demonstrate compliance with the Regulations, the operator must complete a solvent management plan annually. The solvent management plan serves the following purposes:

1. Identifies the principles to be applied.

2. Provides a framework for the mass balance.

3. Verification of compliance with:

a) the reduction option; or

b) emission limit values in waste gases, fugitive emission values and/or total

emission limit values as stated in Schedule 2;

Condition 6.17 of the Vistakon’s IPPC licence requires Vistakon to prepare a SMP. The SMP shall demonstrate compliance with the solvent and fugitive emission limit requirements.

2.2.2 Risk Phrases Certain substances classified as carcinogenic, mutagenic or toxic (Risk Phrases R45, R46, R49, R60, R61) must be replaced where possible with less harmful substances, and these substances along with halogenated volatile organic compounds with Risk Phrase R40 must comply with separate emission limit values regardless of the overall compliance method.

The Solvent Emission Directive states: “For discharges of the VOCs with R_Phrases R45, R46, R49, R60, R61, where the mass flow of the sum of the compounds causing the labeling referred to in that paragraph is greater than, or equal to, 10g/h, an emission limit value of 2 mg/Nm3 shall be complied with. The emission limit refers to the mass sum of the individual compounds.” And; “For discharges of halogenated VOCs which are assigned the risk phrase R40, where the mass flow of the sum of the compounds causing the labeling R40 is greater than, or equal to, 100g/h, an emission limit value of 20 mg/Nm3 shall be complied with. The emission limit value refers to the mass sum of the individual compounds.”

2.3 Vistakon Compliance Thresholds To demonstrate compliance with the Regulations, Vistakon will use the Emission Limit Value Scheme. Under the Second Schedule of the Regulations the activity defines as “Other Coating including metal, plastic, textile” (i.e. Activity number 8) detail the solvent consumption and Emission Limit Value thresholds under which Vistakon must comply:

Table 2.1: Vistakon Emission Limit Values Activity Threshold (solvent consumption) ELV in waste gases Fugitive EV

Tonnes/year Mg/Nm3 % of solvent input 8 >200 75 15%

3. VISTAKON SOLVENT MANAGEMENT PLAN

3.1 Introduction The following sections outline the methodologies adopted for the determination of solvent (including R‐phrase solvents) and fugitive emission levels from the Vistakon facility and for the verification of compliance.

3.2 Methodology 3.2.1 Solvent Emissions

The solvent emission levels from the Vistakon facility were determined through a screening assessment of solvent (VOC) consumption inventories and evaluation of VOC emission discharges. For the purpose of this assessment, VOCs were defined as:

“any organic compound having at 293.15 K a vapour pressure of 0.01 kPa or more, or having a corresponding volatility under the particular conditions of use” Only organic solvents used in process activities and in volumes exceeding 100 l or names R‐phrases and deemed to satisfy the above definition for a VOC (as defined in the Solvent Emission Directive) were included in the assessment. Measurement of VOC emission at point source discharges was carried out to determine compliance with the Regulations. All measurements were carried out by an independent accredited laboratory.

3.2.2 Fugitive Emissions A mass balance methodology is applied for the determination of fugitive emissions using either of the following equation: F = I1 – O1 – O5 – O6 – O7 – O8 Or F = O2 + O3 + O4 + O9 The fugitive emission value is expressed as a proportion of the input, which can be calculated according to the following equation – I = I1 + l2

Mass Balance Definitions Inputs of organic solvents (I) – I1 The quantity of organic solvents or their quantity in preparations purchased in 2009 which are

used as input into the process in the time frame over which the mass balance is being calculated.

l2 The quantity of organic solvents or their quantity in preparations recovered and reused as solvent input into the process.

Mass Balance Definitions – continued Outputs of organic solvents (O) – O1 Emissions in waste gases O2 Organic solvents lost water, if appropriate, taking into account waste water treatment when

calculating O5 O3 The quantity of organic solvents which remains as contamination or residue in products output

from the process O4 Uncaptured emissions of organic solvents to air. This includes the general ventilation of rooms,

where air released to the outside environment via windows, doors, vents and similar openings

O5 Organic solvents and/or organic compounds lost due to chemical or physical reactions (including for example those which are destroyed e.g. by incineration or other waste gas or waste water treatments, or captured e.g. by absorption, as long as they are not counted under O^, O7 or O8.

O6 Organic solvents contained in collected waste O7 Organic solvents, or organic solvents contained in preparation, which are sold or are intended

to be sold as a commercially valuable product. O8 Organic solvents contained in preparations recovered for reuse but not as input into the

process, as long as not counted under O7. O9 Organic solvents released in other ways

3.3 Compliance Verification

3.3.1 Vistakon VOC Emissions Solvent Inventory The following table details solvents in use at the Vistakon facility, their CAS number & the Risk Phrase associated with them (where not deemed confidential due to commercial sensitivity) and the volume used in 2009.

Table 3.1: Solvents and Quantities used at Vistakon No. Compound CAS Number Risk Phrases Usage (kg) /yr 1 Isopropyl Alcohol 67‐63‐0 R11,36,67 2,669,960 2 Propylene Glycol 57‐55‐6 N/A 452,000 Total 3121960 For the purpose of this assessment, solvent emission values for 2009 will be used to determine compliance with the requirements of the Solvent Emissions Directive (SED). This is due to the availability of monitoring data for solvent emissions. All solvents were identified on site. Propylene Glycol (PG) was introduced as a potential alternative to IPA, it is a material with very low volatility (PG evaporation rate = 1.57E‐02, where (n‐Butyl Acetate = 1) and Iso‐Propyl Alcohol is 1.5) Only IPA and Propylene Glycol was assessed against the requirements of the SED as it accounts for over 99.9% of all solvent use. All the other solvents used within the process at the Vistakon site make up less them 0.1% solvent use.

3.3.2 Fugitive Emissions All solvents were identified on site and only IPA & PG was assessed against the requirements of the SED as it accounts for 99.9% of all use. For purposes of the fugitive emission calculations, specific density was used to determine an input value in kilograms in Table 3.3.

Table 3.2: Solvent Consumption in kg No Name Consumption kg/Year 1 Isopropyl Alcohol 2,669,960 Propylene Glycol 452,000 Total 2,702,800 Fugitive emissions were calculated based on the VOC emission measured during a VOC survey of minor roof vents undertaken during 2008. The total VOC measured was 4.4x10‐2kg/hour, which equates to 385kg/year. Because of its low volatility PG potential fugitive emissions are estimated at zero. During 2010 waste solvents with high water content was sent off‐site for disposal and is accounted for in O6. Any trace IPA/PG in the wastewater is sent for treatment in the local wastewater treatment plant, IPA & PG are very biodegradable in these systems. Based on the average COD in the wastewater IPA/PG concentrations are expected to be less than 100mg/L of each solvent leaving the site, this would equate to 26122kg/year in the wastewater. Any remaining IPA/PG emissions are directed to the thermal oxidizer/abatement system, a total of 494kg/year, which equates to 824kg as IPA (59.9% VOC).

3.3.3 Receipt of Solvent to Site IPA solution is supplied by road tanker to the Vistakon site on a routine basis. In 2010 a total of 2669T of IPA was shipped to site. A tanker un‐loading panel is provided including dedicated discharge pump, filter, mass flow meter and shut‐off isolation valve. The tanker bay is located within a bunded area, with drainage to a containment sump, sized to hold the total capacity of the road tanker plus 10% in the event of accidental spillage. The containment sump is isolated during the un‐loading & loading operation. Rainwater collected within the sump is tested prior to disposal. Contaminated rainwater is collected for off‐site disposal by a waste disposal tanker. Non‐contaminated rainwater is discharged into the storm water sewer which enters an interceptor prior to the municipal system. PG is supplied in IBC’s to the Vistakon site on a routine basis. In 2010 a total of 452T of PG was shipped to site. The IBC’s are stored in a small bunded area. Contaminated rainwater is collected for off‐site disposal by a waste disposal tanker. Non‐contaminated rainwater is discharged to the process effluent.

3.3.4 Solvent Storage and Distribution

The IPA storage tanks are provided with a conservation vent and nitrogen for blanketing and relief device for emergency pressure / vacuum protection. Displaced vapours from the tank are vented via a common collection header to an abatement system prior to discharge to atmosphere at emission point A2‐1. Tank instrumentation will include a level transmitter for

monitoring and control and high and low level switches for pump shutdown protection. During IPA off‐loading, the vapour is collected and treated in the abatement system. Clean IPA from the bulk storage tank is pumped by the clean IPA supply pumps to a day buffer tank (3,500 L) located within the distribution building. The bulk clean IPA is heated or cooled, depending upon the ambient temperature, by a plate heat exchanger, from ambient temperature to a set point temperature. The clean IPA is then pumped to the manufacturing lines. The day tank is provided with a conservation vent and nitrogen for blanketing and relief device for emergency over‐pressure protection. Tank instrumentation includes level, pressure and temperature transmitters for monitoring and control and high and low level switches for pump shutdown protection. The tank vents to a collection header for abatement in the abatement system. From the clean IPA day tank, duty/standby pumps transfer IPA into supply and return distribution loop to serve the manufacturing lines or re‐circulate back to the day tank. The PG IBCs are pumped directly to the manufacturing area, there are no fugitive emissions generated in this process as the PG has negligible potential vapor emissions.

3.3.5 Disposal of Used Solvent from Site The used IPA rinse solution is collected within a sump in the lens manufacturing machine and pumped back to the used IPA day tank (2,500 L). This is located outside in the bulk tank area. Used IPA is pumped from the used IPA day tank to the used IPA bulk storage tank. IPA, which has been used in the manufacturing process, is removed by road tanker from the Vistakon site and supplied to a 3rd party licensed facility for external solvent recovery. In 2010 a total of 4291 T of 51% IPA was shipped offsite for external solvent recovery. As water is added to the IPA for the process there is a greater volume of liquid leaving the site than is received. The used PG is pumped directly for collection in waste IBC’s for supply to a 3rd party licensed facility for external solvent recovery. In 2010 a total of 425T of 95% PG was shipped offsite for external solvent recovery.

3.3.6 Mass Balance Calculation The mass balance based on the aforementioned figures is presented below:

Table 3.3: Mass Balance Calculations Solvent No. 1 2 Total kg I1 Consumed 2669960 452,000 3,100,800 O1 Air Emissions 824 0 634 O2 Wastewater 26 26 60 O4 Fugitive VOCs in air 0.4 0 0.4 O5 Abatement 457823 26766 484589 O6 Liquid Waste Disposal 2212987 425260 2,631,665

The total fugitive solvent value is less than the figure calculated below in Table 3.4 demonstrating that fugitive emissions for the site are in compliance with the required cap of the 15% total solvent usage. All other solvents are used in closed loop processes with no opportunity for fugitive emissions.

Table 3.4: Fugitive Emission Calculations Input kg/y

Output kg/y

Fugitive kg/year

No. Solvent

I1 O1 O5 O6 F 1 IPA 2669960 824 457823 2212987 26 2 PG 452,000 0 26766 452260 26 Total 3,100,800 634 70,441 2,631,665 52 Limit (15% of

total input) 468294 ‐ ‐ ‐ 0 Schedule 2 ‘Thresholds and Emission Controls’ of the Regulations specifies a fugitive emission values for existing installations of 15% of solvent input. The value obtained above is well within this limit.

4. Conclusion Vistakon is in compliance with S.I. No. 543 of 2002 (Emissions of Volatile Organic Compounds from Organic Solvents) as outlined in the Second Schedule of the Regulations for the activity defined as “Other Coating including metal, plastic, textile” (i.e. Activity number 8). Vistakon, as outlined in this report meets the specific emission limit value in waste gases of 75 mg C/Nm3 and the 15% fugitive emission limit requirement.