Pfizer Ireland Pharmaceuticals, Little Island · 2014-12-16 · • Compressed air generation • Nitrogen ... The latest IPPCL for Pfizer Ireland Pharmaceuticals has been effective

Annual Environmental Report 2010

Pfizer Ireland Pharmaceuticals, Little Island IPPC Licence Reg. No. P0136-04

ANNUAL ENVIRONMENTAL REPORT 2010 ______________________________________________________________________________________

This Annual Environmental Report 2010, has been prepared using the guidelines from the Environmental Protection Agency’s publication “Integrated Pollution Control Licensing, Guidance note for Annual Environmental Report”, published in October 2000. As specified in the guidance document all summary information is presented for the previous calendar year 2010, unless otherwise specified. A submission of summary information in electronic format will be made to the EPA, as requested in the guidance document.


CONTENTS 1.0 INTRODUCTION

1.1 Pfizer Ireland Pharmaceuticals, Little Island 1.2 Site description 1.3 Environmental, Health and Safety Policy 1.4 Company Organisation

2.0 2010 Summary Data

2.1 Emissions to atmosphere 2.2 Emissions to sewer 2.3 Emissions to surface water 2.4 Non Compliances 2010 2.5 Waste Management 2.6 Ambient Monitoring 2.7 Agency monitoring and enforcement 2.8 Noise Monitoring 2.9 Resource consumption 2.10 Environmental incidents & complaints 2.11 Energy Efficiency Audit Report Summary

3.0 Environmental Management Programme Report

4.0 Pollution Release and Transfer Register 5.0 Proposals for AER period January to December 2011

5.1 Objectives and Targets 5.2 EMP Proposal 5.3 Noise monitoring programme proposal

Appendix

1. Ground Water Summary 2. Environmental Management Programme Report for 2010 3. Environmental Management Programme Proposal for 2011 4. Bund Integrity Report 5. Electronic PRTR 6. Review of Decommissioning Management Plan 7. Statement of Measures Covering Environmental Liabilities 8. Underground pipe line testing summary for 2010 9. Water demand and trade effluent generation minimisation

ANNUAL ENVIRONMENTAL REPORT 2010 ______________________________________________________________________________________ 1.0 INTRODUCTION

1.1 Pfizer Ireland Pharmaceuticals, Little Island

IPC Licence Register Number : P0136-04

Site name : Pfizer Irl. Pharmaceuticals

Site location : Little Island Industrial Estate, Wallingstown, Little Island, Co. Cork.

1.2 Site Description

The Pfizer Ireland Pharmaceuticals Ltd. facility in Wallingstown, Little Island, Co. Cork, Ireland is a manufacturer conducting chemical synthesis of bulk active ingredients for use in pharmaceutical manufacturing. The site was developed from green field in 1978.

Production is batch wise, with batch sizes ranging from 10kg – 1,700 kg. Production takes place in 10 “reactor groups” with groups typically consisting of:

• 2 reactors with 1 receiver • crystaliser • centrifuge • dryer

The current site is comprised of approximately 4.8 hectares of useable land. Current production facilities occupy approximately 8,600 m2 of the site comprising:

• two-story building, housing laboratories and administration • multi-story pilot plant building ( a high containment facility) • single-story warehouse building • two-story production building • two-story utilities building • main fresh solvent drum and waste storage area • tank farm for raw materials and waste solvents • an outdoors drum store, on hard standing with secondary containment • wastewater treatment plant • multi-story dryer building • a drum storage building


2 2

The following utilities are listed and are mainly located in the utilities building: • Steam generation • Electricity from the ESB • Mains water from Cork County Council • De-ionised water generation • Compressed air generation • Nitrogen • Chilling systems

An IPPC Licence application was made to the EPA in July 2010, to facilitate the use of clean distillates in the sites steam boilers and enable waste acceptance on site. The latest IPPCL for Pfizer Ireland Pharmaceuticals has been effective since Jan 2011 (P136-04). This AER has been generated in compliance with IPPC licence the effective IPPC licence for 2010 (P0136-03).


3 3

1.3 Environmental, Health and Safety Policy Pfizer Ireland Pharmaceuticals, Little Island OPS 1-3 is involved in the manufacture

of active pharmaceutical ingredients. These products make an important contribution

to the healthcare industry.

We are committed to conducting our operations in a manner that protects the

environment, our colleagues, contractors, the public and the local community and in

compliance with all relevant environmental, health and safety regulations and Pfizer

requirements. Our belief is that if a job cannot be done safely, it will not be done.

Pfizer Ireland Pharmaceuticals, Little Island is committed to continually seeking to

improve our EHS performance by reporting of near-misses and other EHS incidents,

by investigating these to root cause and by timely closure of improvement actions.

While responsibility for safety on site is through line management, everyone on site is

expected to work in a manner which does not put themselves or others at risk.

The Company implements and maintains programmes to:

Minimise the risk of injuries, and major and minor incidents occurring, through a risk

assessment approach,

Monitor and evaluate, on a routine basis, the site environment, health and safety

protection programmes to assure high standards are being maintained.

Design, construct, operate, maintain and manage its operations to high standards.

Provide procedures and training to ensure all employees can carry out their duties in a

manner which does not compromise safety, product quality or the environment.

Foster a culture of ownership and accountability for Safety through delivery of the

“Safety Commitments” and associated goals.

We are committed to conserving natural resources and preventing pollution by where

possible reducing wastes at source, reusing and recycling material and disposing of

waste safely. We will aim for innovative and environmentally sound technologies

throughout our business activities.

We foster openness and dialogue with colleagues and the public about our health,

safety and environmental performance, responding, in particular, to any concerns they

have about the potential hazards and impacts of our operations, products, emissions

and waste. We encourage and facilitate colleague involvement in the planning,

implementation and evaluation of safety and environmental projects and initiatives.


4 4

We encourage similar health, safety and environmental standards to our own from all

third parties involved with our business - suppliers, contractors and vendors.

We are committed to operating an Environment and Health & Safety Management

System and a Major Accident Prevention Plan as per ‘Control of Major Accident

Hazards involving Dangerous Substances’ This provides Pfizer Ireland

Pharmaceuticals, Little Island with the framework for implementing this policy and

setting and reviewing safety and environmental goals, objectives and targets.

The Company’s Environmental, Health and Safety Policy is publicly available,

communicated to all employees, made available to stakeholders and the public and

regularly reviewed to reflect legislative and company changes.


5 5

1.4 Company Organisation

Environmental aspects are integrated into the company at the top management level. New processes and changes to existing processes are scrutinised to ensure compliance with the company’s environmental, health and safety policy. The following charts 1.4.1 to 1.4.2 show the site leadership structure and the EHS Department structure.


Site Leadership Team Figure 1.4.1

Site Leader Seamus Fives

Operations Leader Ian O’Driscoll

QO & EHS Leader

Rachael Buckley

Materials Team Leader

Alastair Dunne

Human Resources Leader

Deirdre O’Brien

Tech Services Leader

Billy Oakes

Op Ex Leader Vacant

Finance Lead Fiona MacCarthy

Administrator Deirdre Furney


EHS Department

Figure 1.4.2 The site operates an Environmental, Health & Safety Management System.

ANNUAL ENVIRONMENTAL REPORT 2010 ______________________________________________________________________________________ Key Elements of Environmental, Health & Safety Management System

ORGANIZATION AND PERSONNEL

MONITORING PERFORMANCE

OPERATIONAL CONTROL

IDENTIFY HAZARDS

PLANNING FOR EMERGENCIES

MANAGEMENT OF CHANGE

AUDIT AND REVIEW


9 9

2.0 2010 Summary Data 2.1 Summary of Emissions to Atmosphere

A summary of the figures recorded for emissions to atmosphere from the plant for 2010 are included in Tables 2.1.1, 2.1.2 & 2.1.3. The results for Table 2.1.1 were calculated using grab sample data from samples taken throughout the year. A mass emission (kg/hr) was calculated for each grab sample. An average figure was determined and the annual value calculated using the total hours of operation for the year. Results are reported only for V46 and V6 as V8 was not used in 2010 hence monitoring was not carried out at this vent.

Table 2.1.1 Thermal Oxidiser V46

Parameter

Monitoring Frequency

Mass Emissions (kg)

Licensed Mass

Emissions (kg)

2009

2010

TA Luft Class 1 Organics

Monthly - -

876


Monthly 1,316 173

17,520


Monthly 909 1024

26,280

Sulphur Dioxide

Annually

1095 <1095

NS1

Ammonia

Annually 0.219 8.541

NS1

HCl

Continuous 0.00 0.00

2621

Dioxins

Annually 2.628 x 10-7 3.504 x 10-7

NS1

NOx

Annually 4380 8103

NS1

CO

Annually 1752 1095

NS1

Note 1 NS - Not specified. No loading limits are specified in the licence for these

parameters


10 10

Table 2.1.2 Adtec V6

Parameter


2009

2010

Limit

HCL Continuous <1kg <1.2kg 2,628 kg

Chlorine Continuous <1g 0.74g 438kg

Ammonia Annually 0.0005Kg 0.0009Kg NS1

TA Luft II Monthly <0.090Kg <0.012Kg 17,520kg

TA Luft III Monthly <0.450Kg <0.012Kg 26,280kg

Note 1 : NS – Not Specified. No loading limits are specified in the licence for these

parameters. Table 2.1.3 Boilers V1 & V28

Parameter

Vent


2009

2010

NOx

V1

Biannually 106ppm 106ppm

V28

Biannually 84ppm 88ppm

Combustion Efficiency

V1

Biannually 93.60% 95.39%

V28

Biannually 93.45% 95.70%

Note 1: Light oil fuel or diesel oil were not used in 2009 & 2010.


11 11

Table 2.1.4 Dust Extraction Vents (V4, V5, V9 & V59)

Parameter


Concentration (mg/m3)

2009

2010

Dust from V4 Annually <0.10 <0.33



Dust from

V59 Annually <0.10 <0.24

Table 2.1.5 Contractors Employed for Air Monitoring Contractor M CERT Qualifications/

Accreditation Laboratory Standard

City analyst Level 2 ISO 17025 Axis Environmental Services

Level 2 ISO 17025


12 12

2.2 Summary of Emissions to Sewer A summary of the figures recorded for emissions to sewers from the plant for 2010 are included in Table 2.2.1, 2.2.2 and 2.2.3. This data is based upon average monitoring data available from analysis carried out in accordance with schedule 2(i) of the IPPC Licence. Non-compliances recorded in 2010 are presented in Table 2.2.3.

Table 2.2.1

Parameter


2009

2010

Licence Limits

pH

Daily

6.6 - 8.1 (Range)

6.8 – 7.9 (Range)

6.5-8.5 (Range)

Maximum Temperature (°C)

Daily

30 30

Not more than

30°C

Table 2.2.2 Toxicity Testing

Parameter


June 2010 December

2010

Toxicity

Vibrio fisheria 5 min

EC50 (Microtox

test)

Biannually <2.2 <2.2

Vibrio fisheria 15 min EC50 (MIcrotox

test)

Biannually <2.2 <2.2

Inhibition of oxygen

consumption by activated

sludge Toxic Units

Biannual < 2TU <2TU


13 13

Table 2.2.3 Emissions to sewer.

Parameter


Mass Emissions (kg)

Licensed

Mass Emissions

(kg)

2009

2010

Flow

Continuous 104,824m3 118,677m3

365,000m³

COD

Daily 59,149 19,213

219,000

BOD

Weekly 3,878 1,564

109,500

Suspended solids

Weekly 14,184 5,825

36,500

Phosphorous

Monthly 446 224

18,250

Total Nitrogen

Monthly 1,818 1,116

36,500

Nitrogen as Ammonia

Weekly 84 193

3,650

Fats, Oils & Greases

Monthly <2096 <1187

7,300

Sulphate

Monthly 18,632 18,029

NS1

Chloride

Monthly 34,103 35,366

NS1

Total heavy metals

Annually <48.39 <45.73

182.5

Aluminium

Annually <21.0 <15.5

NS1

Arsenic

Annually 0.104 <0.178

NS1

Cadmium

Annually <0.05 <0.04

NS1

Chromium

Annually 0.09 0.24

NS1

Zinc

Annually 0.99 1.59

NS1


14 14

Parameter


Mass Emissions (kg)

Licensed

Mass Emissions

(kg)

2009

2010

Copper

Annually 1.05 <12.35

NS1

Mercury

Annually 0.01 <0.01

NS1

Manganese

Annually 8.33 3.02

NS1

Nickel

Annually 4.06 3.13

NS1

Lead

Annually 0.10 <0.08

NS1

Tin

Annually <10.48 <6.08

NS1

Titanium

Annually <10.48 <6.53

NS1

Note 1 NS - Not specified. No loading limits are specified in the licence for these

parameters


15 15

Table 2.2.4 Summary of GC Monitoring of final effluent

Analysis of final effluent, monthly, for VOCs, semivolatiles and major solvents gave results less than the detection limit, except for the following samples. Parameter Jan

Feb

Mar

Apr

May

Jun

Jul

Aug Sep

Oct

Nov

Dec

Toluene (ppm) LOD LOD LOD LOD LOD LOD LOD LOD LOD LOD LOD LOD Cyclopentanone (ppm) LOD LOD LOD LOD LOD LOD LOD LOD LOD LOD LOD LOD Acetone (ppm) LOD LOD LOD LOD LOD LOD LOD LOD 0.05 0.03 0.02 LOD Ethyl Aceate (ppm)

LOD LOD LOD LOD LOD LOD LOD LOD LOD LOD LOD LOD

Methanol (ppm)

LOD 1.30 LOD LOD LOD LOD LOD LOD LOD LOD LOD LOD

Hexane (ppm) LOD LOD LOD LOD LOD LOD LOD LOD LOD LOD LOD LOD Isopropyl Alcohol (ppm)


Ethanol (ppm) LOD LOD LOD LOD LOD LOD LOD LOD LOD LOD LOD LOD Triethylamine (ppm) LOD LOD LOD LOD LOD LOD LOD LOD LOD LOD LOD LOD MTBE (ppm) 2.30 2.60 1.50 LOD LOD 0.02 LOD 0.01 0.01 LOD LOD 5.00 THF (ppm) LOD 1.80 LOD LOD LOD LOD LOD LOD LOD LOD LOD LOD TMOF (ppm) LOD LOD LOD LOD LOD LOD LOD LOD LOD LOD LOD LOD Di-isopropyl amine (ppm)


Tert butyl acetate (ppm)


LOD: Less than the limit of detection


2.3 Summary of Emissions to Surface Water

A summary of the figures recorded for emissions to surface waters from the plant for 2009 & 2010 are included in Table 2.3.1. Table 2.3.1 Emissions to surface water.

Parameter


Mass Emissions (kg)

2009 2010

Flow (m3)

N/S

1,239,003m3

Note 1 589,551m3

Temperature (ºC)

Monthly 8.5 – 20.9 7.4 – 21.0

TOC

Monthly 0-150mg/l

Note 2 0-150mg/l

Note 2

PH

Continuous > 5 and < 9

Note 2 > 5 and < 9

Note 2

Visual Check / Odour

Daily All samples were clear and

odourless

Note 1 The storm water flow for 2009 and 2010 was calculated by taking the final

effluent flow from the total water used on site. Note 2 TOC and pH of storm water are continuously monitored prior to discharge. The

automated system shuts the final outfall valve when the action limits as specified in the IPPC licence are reached, and diverts the storm water into the firewater retention pond.


2.4 Non- Compliances for 2010 Table 2.4.1. Non-compliances for 2010 Date Non-compliance Corrective Action There were no non-compliances in 2010.


2.5 Waste Management

Pfizer Ireland Pharmaceuticals Ltd., Little Island, maintains a full record of all waste arising on site. From this information it is possible to compile a yearly summary of all hazardous and non-hazardous waste produced. Table 2.4.1 presents the yearly totals for hazardous waste and non-hazardous waste produced on site while Table 2.4.2 presents the disposal contractor details. The Waste Management Records are available on-site for review and contain the details of all waste shipments off-site. Due to the size of this document and with prior permission from the Agency it is not included in this AER. Table 2.4.3 presents data for inclusion in the National Waste Database (NWD).


Table 2.5.1 Details on hazardous and non- Hazardous waste produced in 2010 on the Little Island Site

Waste material EWC code Source

(Tonnes /

Annum)

Hazardous (Yes/No)

Quantity / annum

Method of Disposal Recovery

Name of Waste Disposal /Contractor

Location of disposal Recovery

Caustic Scrubber waste 06 02 05 Production 22.12 Yes 22.1 D10 Sava Brunsbuttel, Germany

Aqueous washing liquors and mother liquors 07 05 01 Production 3582.92 Yes

26.6 D13 Blending Facitily Fermoy Corrin, Fermoy Co.Cork 66.4 D10 Pfizer Sandwich, E 2.6 D10 Willacy Guinard Holdings Ltd. Southhampton UK

675.9 D10 Veolia Ellesmere Port

Bridges Road, Ellesmere Port,Cheshire L65 4EQ, UK

37.7 D10 Sava Brunsbuttel, Germany 556.7 D13 Blending Facitily Fermoy Corrin, Fermoy Co.Cork

1988.5 D13 Blending Facitily Fermoy Corrin, Fermoy Co.Cork 23.9 R13 Blending Facitily Fermoy Corrin, Fermoy Co.Cork

204.7 R2 Blending Facitily Fermoy Corrin, Fermoy Co.Cork Acetone for recovery 07 05 04 Production 616.53 Yes 616.5 R2 Pfizer Ringaskiddy Ringaskiddy Co.Cork Toluene for recovery 07 05 04 Production 297.36 Yes 297.4 R2 Pfizer Ringaskiddy Ringaskiddy Co.Cork MTBE for recovery 07 05 04 Production 1538.11 Yes 1538.1 R2 Pfizer Ringaskiddy Ringaskiddy Co.Cork

Other organic solvents 07 05 04 Production 9203.98 Yes

21.7 D13 Blending Facitily Fermoy Corrin, Fermoy Co.Cork 1423.7 R13 Blending Facitily Fermoy Corrin, Fermoy Co.Cork 5473.5 R2 Blending Facitily Fermoy Corrin, Fermoy Co.Cork

21.3 R12 GVS GmbH & Co.KG Germany 0.1 D10 Remondis NL Bramsche GmbH

42.5 R2 Sita Eco Services Almelo, Netherlands

ANNUAL ENVIRONMENTAL REPORT 2010 _____________________________________________________________

20 20


(Tonnes /

Annum)

Hazardous (Yes/No)

Quantity / annum




Other organic solvents

07 05 04

Production

7540.4

Yes

45.2 D13 Veolia ES Fermoy Corrin, Fermoy Co.Cork

546.2 R2 Veolia Garston King Street , Liverpool, Lancashire L19 8EG,UK

0.1 D10 Willacy Guinard Holdings Ltd. Southhampton UK 1072.1 R2 SRM Morecambe, UK

352.9 R3 SRM Morecambe, UK 204.7 R2 BIP Organics Cheshire, UK

Organic Liquid Waste 07 05 04 Production 9.48 Yes 9.5 D10 Sava Brunsbuttel, Germany Excess sludge

07 05 12 Waste Water

Treatment Plant

622.08

No 622.1 R1 Eras Eco Foxhole, Youghal, Co. Cork

Solids/Packaging 07 05 13 Plant wide 114.67

Yes 114.2 D10 Sava Brunsbuttel, Germany

0.4 D13 Veolia ES Fermoy Corrin, Fermoy Co.Cork Waste Printer /Toner 08 03 18 Plant wide 1.08 No 1.1 R13 Source Imaging Ltd Banagher Co. Offaly

Ferrous Metal Filllings & Turnings 12 01 01 Maintenance 0.63

No 0.6 R4 KMK Metals Tullamore, Co. Offaly Other engine, gear and

lubricating oils 13 02 08 SiteWide

0.29 Yes 0.29 R2 Veolia ES Fermoy Corrin, Fermoy Co.Cork 3.80 Yes 3.80 D9 Enva Ireland Portlaoise, Co. Laois 0.12 Yes 0.12 D10 Sava Brunsbuttel, D 0.04 Yes 0.04 R13/R4 Veolia ES Fermoy Corrin, Fermoy Co.Cork


21 21


(Tonnes /

Annum)

Hazardous (Yes/No)

Quantity / annum




Fuel Mixtures 13 07 03 Site Wide 2.00 Yes 2.00 D9 Enva Ireland Portlaoise, Co. Laois Timber Pallets

20 01 38 Plant Wide 48.10 No 48.1 R13 Veolia Forge Hill

Forge Hill, Kinsale Road, Co. Cork

Iron and Steel 20 01 40 Plant wide 18.96 No 19.0 R4 Cork Metal Dublin Hill, Cork Metal (Drinks Cans ) 15 01 04 Plant Wide 7.97 No 8.0 R4 Rehab Recycling partnership Monahan Road , Cork

Drums (empty)

15 01 10 Production 166.30

Yes

13.0 D10 Sava Brunsbuttel, Germany 24.8 D13 Veolia ES Fermoy Corrin, Fermoy Co.Cork

127.5 R4 Veolia ES Fermoy Corrin, Fermoy Co.Cork 0.4 D10 Willacy Guinard Holdings Ltd. Southhampton UK 0.2 R13 Blending Facility Fermoy Corrin, Fermoy Co.Cork 0.4 D13 Veolia ES Fermoy Corrin, Fermoy Co.Cork

PPE- Filter NOS contaminated with

dangerous substances 15 02 02 Production 11.48

Yes

11.4 D10 Sava Brunsbuttel, Germany

0.1 D13 Veolia ES Fermoy Corrin, Fermoy Co.Cork TV's & Monitors 16 02 13

Site Wide 1.00 Yes 1.0 R4 KMK Metals Tullamore, Co. Offaly

Electrical Waste (PC's) 16 02 14 4.10 No 4.1 R4 KMK Metals Tullamore, Co. Offaly Scrap Cables 16 02 16

Production 0.71 No 0.7 R4 KMK Metals Tullamore, Co. Offaly

Gas Cycliners 16 05 04 0.09 Yes 0.1 D10 Willacy Guinard Holdings Ltd. Southhampton UK Lab Smalls- Inorganic 16 05 07 Laboratories 0.41 Yes 0.4 D10 Sava Brunsbuttel, Germany

Gas Cylinders

16 05 08 Plant wide 1.42 Yes 0.3 D10 Sava Brunsbuttel, Germany Yes 1.1 D10 Sava Brunsbuttel, Germany Yes 0.0 R2 Sava Brunsbuttel, Germany

Batteries - lead 16 06 01 Plant wide 0.59 Yes 0.6 R4 KMK Metals Tullamore, Co. Offaly


22 22


(Tonnes /

Annum)

Hazardous (Yes/No)

Quantity / annum




Batteries - Ni-Cd 16 06 02 Plant wide 0.05 Yes 0.0 R4 KMK Metals Tullamore, Co. Offaly Batteries - Alkaline 16 06 04 Plant wide 0.04 No 0.0 R4 KMK Metals Tullamore, Co. Offaly

Spent catalyst containing heavy metals - Nickel 16 08 02 Production 66.57 Yes 66.6 R4 Nickelhuette Aue GmbH

Rudolf-Breitscheid-StraBe, 08280 Aue, Germany

Fibre Kegs/Cardboard/Paper 20 01 01 Plant Wide 32.28

No 32.3 R13 Veolia Forge Hill Forge Hill, Kinsale Road, Co. Cork

Glass 20 01 02 Plant Wide 3.33 No 3.3 R13 Rehab Recylicng Partnership Monahan Road , Cork Solids/Packaging (Acids)

20 01 14 Plant wide 33.68 Yes 27.9 D13 Veolia ES Fermoy Corrin, Fermoy Co.Cork Yes 0.0 D15/D10 Veolia ES Fermoy Corrin, Fermoy Co.Cork Yes 5.8 D10 Sava Brunsbuttel, Germany

Flourescent tubes & other mercury containing

waste 20 01 21 Plant wide 0.34

Yes 0.1 R4 Irish Lamp Recycling Athy, Co. Kildare

Yes 0.3 R4 KMK Metals Tullamore, Co. Offaly Cooking oil

20 01 25 Canteen 0.76 No 0.8 D13 Blending facility Fermoy Corrin, Fermoy Co.Cork 0.11 No 0.1 D10 Sava GmbH & Co. KG Brunsbuttel, Germany

Paints, Inks & Adhesives 20 01 27 Plant wide 1.79

Yes 1.8 D10 Sava GmbH & Co. KG Brunsbuttel, Germany Rubble

17 01 07 Site Wide 59.44 No 59.4 R13 Green Star- Forgehill

Green Star- Forgehill, Cork

Concrete 17 01 01 Picket Fence

Thickner 40.28 No 40.3 R5 Ashgrove

Churchfield Industrial Estate Cork


23 23


(Tonnes /

Annum)

Hazardous (Yes/No)

Quantity / annum




Mixed Construction & Demolition waste 17 09 04 New gram

lab 2.02 No 2.0 D1 Ashgrove

Churchfield Industrial Estate Cork

GW Composting 20 01 08 Canteen 9.10

No 9.1 R3 Miltown Composting Facility Fethard Co. Tipperary General waste

20 03 01 Plant wide 66.50 No 66.5 D1 Veolia Forge Hill

Forge Hill, Kinsale Road, Co. Cork

ANNUAL ENVIRONMENTAL REPORT 2010 ______________________________________________________________________________________ Table No. 2.5.2 : Waste Disposal/Contractor and Licence Permit Reference



Licence Permit Reference

Sava Brunsbuttel, D A51/V00605 Veolia ES Fermoy Corrin, Fermoy Co.Cork W050-2 Pfizer Sandwich, UK HP 3539LX Willacy Guinard Holdings Southhampton UK EPR/FP3935KL

Veolia Ellesmere Port Bridges Road, Ellesmere Port,Cheshire L65 4EQ, UK CH654EQ

GVS GmbH& Co.KG Mainheim, Germany H19139480 Remondis NL Bramsche, Germany CFD000000 Sita Eco Services Almelo, Netherlands OV501854VIHB Pfizer Ringaskiddy Ringaskiddy Co.Cork P0013-04

Veolia Garston King Street , Liverpool, Lancashire L19 8EG,UK

EA UK NTFS/AG 3363/BJ8391

SRM (Mor) Morecambe, Lancashire, UK AG 9248 BIP organics Cheshire , UK BS5223IH Eras Eco Foxhole, Youghal, Co. Cork W0211-01 Source Imaging Ltd Banagher Co. Offaly WP 124/06

Greenstar(Veolia Forge Hill) Forge Hill, Kinsale Road, Co. Cork W0173-01

KMK Metals Tullamore, Co. Offaly W0113-03 Enva Ireland Portlaoise, Co. Laoise W-184-1 Cork Metal Dublin Hill, Cork WCP-LK-589

Nickelhuette Aue GmbH Rudolf-Breitscheid-StraBe, 08280 Aue, Germany

64-8823-9104-1.3 &648823.12-9

Ashgrove, Chruch Field Industrial Estate, Cork W041

Rehab Recylicng Partnership Monahan Road , Cork 635 Miltown Composting Facility Fethard Co. Tipperary WP 019 02


25 25

Table 2.5.3 National Waste Database report sheet Industrial Sector NACE Code DG 24 Year 2010 Number of Employees : 240 Item Tonnes Total Quantity of Waste Produced in 2010 16592.6 Total Quantity of Waste Disposed on On-Site 0.0 Total Quantity of Waste Disposed of Off-Site 3730.6 Total quantity of waste Recovered On-Site 0.0 Total Quantity of Waste Recovered Off-Site 12862.1 Item Tonnes Total Quantity of Non-Hazardous Waste Produced in 2010 917.5 Total Quantity of Non-Hazardous Waste Disposed on On-Site 0.0

Total Quantity of Waste Non-Hazardous Disposed of Off-Site 69.4

Total quantity of Non-Hazardous waste Recovered On-Site 0.0 Total Quantity of Non-Hazardous Waste Recovered Off-Site 848.1

Item Tonnes Total Quantity of Hazardous Waste Produced in 2010 15675.4 Total Quantity of Hazardous Waste Disposed on On-Site 0.0 Total Quantity of Hazardous Waste Disposed of Off-Site 3661.3

Total quantity of Hazardous waste Recovered On-Site 0.0 Total Quantity of Hazardous Waste Recovered Off-Site 12014.0


26 26

2.6 Ambient Monitoring As part of IPPC licence P136-03, Pfizer Little Island were required to complete headspace monitoring on an annual basis for 2009 & 2010

Sampling point

Parameter 2009

mg/m3 2010

mg/m3

Headspace above the connection point with the sewer.

Methanol <LOD <LOD

IPA <LOD <LOD

MTBE <LOD <LOD

Hexane <LOD <LOD

Ethyl Acetate

<LOD <LOD

Ethanol <LOD <LOD

<LOD <LOD

TA Luft Class III

<LOD <LOD

<LOD <LOD

THF <LOD <LOD

Toluene <LOD <LOD

<LOD <LOD

TA Luft Class II

<LOD <LOD

Table No.2.6.1


27 27

2.7 Agency Monitoring and Enforcement

EPA analysis reports for aqueous and atmospheric emissions were compared with equivalent results conducted by Pfizer Ireland Pharmaceuticals for 2010. It was not possible to compare all analysis with an equivalent Pfizer result, as the parameters were not scheduled for analysis at the time of sampling by the EPA (e.g. annual and biannual tests). The EPA reports are as follows: Air Monitoring report 22 Sept 2010 Surface water report 24 Apr 2010 Final effluent report 28 Apr 2010 Surface water report 17 Aug 2010 Final effluent report 17 Aug 2010 Surface water report 27 Oct 2010 Final effluent report 27 Oct 2010

In comparing the Agency monitoring with monitoring carried out on-site there were no significant differences in results obtained by Pfizer and those obtained by the EPA,.

ANNUAL ENVIRONMENTAL REPORT 2010 ______________________________________________________________________________________ EPA Inspections / Audits Table 2.7.1 . There was one site inspection by the EPA in 2010 (13 July 2010) Observation Corrective Action Table 2.5.1 of the AER – Waste materials given the EWC codes of 07 05 01 and 07 05 03, were named as packaging’s in the descriptions column. These codes represent “aqueous washing liquids and mother liquids” and “organic halogenated solvents, washing liquids and mother liquors.

Correct Table 2.5.1 with correct descriptions.

Table 2.7.2 There was one site audit by the EPA in 2010 (09 Nov 2010) Observation Corrective Action Environmental Management System targets required to address a five year time frame.

Incorporate 5 year time frame for objectives and targets in AER for 2010.

Additional Information required on bund test sheet

Bund test sheet updated to incorporate recommendations

No example of how compliance is monitored in the noise monitoring report for 2010

Compliance example to be entered into noise monitoring report for 2011.


29

2.8 Noise Monitoring

An environmental noise survey was commissioned by Pfizer Ireland Pharmaceuticals, Little Island, to monitor compliance with the noise limits assigned in IPPC Licence Register No. P0136-03 issued by the Environmental Protection Agency.

The licence assigns a noise limit of 55dB(A) by day and 45dB(A) by night at the nearest

noise sensitive locations (Leq,30minutes). In addition, there shall be no clearly audible tonal or impulsive noise component in the noise emission from the activity at any noise sensitive location. The measured specific noise levels attributable to Pfizer at the nearest noise sensitive locations, and at the plant boundaries, are summarised in Table S1. The measurement locations and nighttime specific noise levels are shown in Figure S1. The daytime and nighttime noise limits were complied with at the noise sensitive locations. There was no clearly audible or measurable tonal or impulsive noise component in the noise emission from the activity at any noise sensitive location.


30

Location Specific Noise Level dB(A) 1

Label Description Daytime Nighttime

Noise Sensitive Locations (subject to IPPC noise limits)

NSL1 St. Lappan’s Place <<49 <44

NSL2 North Eske <<49 <44

NSL3 Factory Hill <<49 <<40

Plant boundaries (not subject to IPPC noise limits)

B1 South East corner of Pfizer site 50 52

B2 South West corner of Pfizer site 54 60

B3 North West corner of Pfizer site <57 60

B4 Northern Boundary <56 56

B5 North East corner of Pfizer site <59 51 Table S.1. Specific Noise Levels, Pfizer Ireland Pharmaceuticals, Little Island,

August 2010 1 The Specific Noise Level is the noise level attributable to Pfizer


31

Figure S.1. Measurement Locations and nighttime specific noise levels, Pfizer Ireland

Pharmaceuticals Little Island, August 2010

NSL1 St. Lappan’s <44dB(A)

NSL2 North Eske <44dB(A)

NSL3 Factory Hill <<40dB(A)

B1 52dB(A)

B2 60dB(A)

B3 60dB(A)

B4 56dB(A) B5

51dB(A)

N


32

Environmental Noise Survey

Pfizer Ireland Pharmaceuticals, Little Island, Cork, August 2010

INTRODUCTION An environmental noise survey was commissioned by Pfizer Ireland Pharmaceuticals,

Little Island, to monitor compliance with the noise limits assigned in Integrated Pollution Prevention and Control (IPPC) Licence Register No.P0136-03 issued by the Environmental Protection Agency (EPA).

The licence assigns a noise limit of 55dB(A) by day and 45dB(A) by night at noise

sensitive locations (Leq,30minutes). In addition, there shall be no clearly audible tonal or impulsive noise component in the noise emission from the activity at any noise sensitive location.

Noise levels were measured at plant boundary and nearest noise sensitive locations by

day and by night. The survey was carried out on the 26th /27th August 2010.

MEASUREMENT DETAILS

Methodology

The survey methodology followed the Environmental Protection Agency (EPA) “Environmental Noise Survey Guidance Document” (2003), EPA “Guidance Note for Noise in Relation to Scheduled Activities” (2006), and ISO 1996 “Description and measurement of environmental noise”.

The measurement duration at each noise sensitive location was 30 minutes during both daytime and night-time. The noise limits apply at the noise sensitive locations only, and do not apply at the plant boundaries. Measurements at reference positions at the plant boundaries are carried out annually to identify trends in overall noise emissions from the site.


33

Measurement Locations

Noise measurements were made at 3 house locations and 5 boundary locations. These are described in Table 1 and indicated in Figure 1. The label notation was modified to a standardised format in 2009, whereby noise sensitive locations are denoted “NSL”, and boundaries are denoted with the prefix “B”. The correspondence with the previous location labels is shown in Table 1.

Location Current Label

Previous Label 1 Description

Noise Sensitive Locations

NSL1 E St. Lappan’s Place At sport’s field 2

NSL2 F North Eske Roadside beside house

NSL3 G Factory Hill Roadside at “Clonmellon”

Plant Boundaries

B1 A South East corner of Pfizer site, in car park adjacent to gas reduction station

B2 B South West corner of Pfizer site, adjacent to Bord Gas site

B3 C North West corner of Pfizer site, in contractors compound

B4 H Northern Boundary, opposite Thermal Oxidiser

B5 D North East corner of Pfizer site, at boundary on bend of access road

Table 1. Noise measurement locations

Note 1: labelling system used in environmental reports up to 2008 Note 2: measurement position selected so that there was good line of sight to Pfizer, but line of sight to

other industrial plants was blocked by the sport’s building.


34

Figure 1. Noise measurement locations

NSL1 St. Lappan’s

NSL2 North Eske

NSL3 Factory Hill

B1 B2

B3 B4 B5

N


35

Measurement and Assessment Parameters

At each measurement location, the average noise level was measured (LAeq), along with the statistical parameters: LA90, LA50, and LA10. These parameters are defined in the Appendix.

The limits in the IPPC licence refer to the component of noise emitted from the licensed activity, as received at the noise sensitive locations. This component of the noise is termed the “specific noise”. The measured total noise level includes the specific noise, and also noise from other sources, such as traffic. The other noise sources are termed the “residual noise”.

Total Noise = Residual Noise + Specific Noise

LAeq (total) = LAeq(residual) + LAeq (specific) During the survey, the specific noise levels due to noise emissions from Pfizer were

established, based primarily on the noise level statistics. This was supplemented, when necessary, by examination of the noise profile (noise levels logged at 10 second intervals). The method of determining the specific noise level is summarised in Table 2.

Description of Noise Noise parameter best representing specific noise from plant

Plant noise dominant, no other significant noise sources LAeq

Interfering noise (e.g. traffic, birds, wind), with underlying plant noise audible

LA90, if plant noise steady and clearly audible in lulls in the interfering noise or LA50, if plant noise slowly varying and clearly audible, with occasional interference from other noise sources

Plant barely audible (i.e. not immediately noticeable, unless actively listening)

< LA90 (up to 5 dB lower)

Plant not audible Not Detectible (ND) <<LA90 (more than 5 dB lower than LA90)

The plant specific noise is established during the survey by correlating the live sound level meter readings with the audible sounds, as described above. The plant specific noise is verified, where necessary, by examining the profile of logged noise levels.

Table 2. Methodology for determination of plant specific noise


36

Measurement Details and Conditions

The survey conditions and instrumentation used are detailed in Table 3. The sound level meter calibration was checked before and after measurement.

Survey Conditions

Survey period Daytime 26th August 2010 Nighttime 26th /27th August 2010

Weather conditions Daytime Dry, light northeasterly breeze (Beaufort 2). Temperature 20°C, humidity 35%.

Nighttime Dry, light northeasterly breeze (Beaufort 1-2). Temperature 11°C, humidity 78%.

Measurement period 30 minutes at each noise sensitive location, 15 minutes at each boundary Plant Operating Conditions

The plant was operating normally during the survey period.

Survey Personnel Colin Doyle BA(mod) M.Sc. PgDip(env) MIOA of ANV Technology

Instrumentation Details

Manufacturer Instrument Calibrated by Calibration reference

Last Laboratory Calibration

Svantek SLM 947 (Type 1) serial no. 5283

AV Calibration 0907329 23/07/09

Svantek SLM 949 (Type 1) serial no. 8183

AV Calibration 0907334

28/7/09

Brüel & Kjær Calibrator 4231 serial no. 1859044

AV Calibration UKAS

04716 21/07/09

Table 3. Survey Conditions and instrumentation details.


37

RESULTS

Noise Levels at Houses and Boundaries The specific noise levels determined at houses and plant boundaries are summarised in

Table 4. Detailed measurement results are presented in Table 5.

Location Specific Noise Level dB(A) 1

Label Description Daytime Nighttime

Noise Sensitive Locations (subject to IPPC noise limits)

NSL1 St. Lappan’s Place <<49 <44

NSL2 North Eske <<49 <44

NSL3 Factory Hill <<49 <<40

Plant boundaries (not subject to IPPC noise limits)

B1 South East corner of Pfizer site 50 52

B2 South West corner of Pfizer site 54 60

B3 North West corner of Pfizer site <57 60

B4 Northern Boundary <56 56

B5 North East corner of Pfizer site <59 51

Table 4. Mean Specific Noise Levels, Pfizer Ireland Pharmaceuticals, August 2010 1 The Specific Noise Level is the noise level attributable to Pfizer

Tonal and Impulsive Analysis

Subjectively the noise was broadband in character at the noise sensitive locations. There were no audible tones or impulsive sounds audible from Pfizer. Measured noise spectra (night-time) at site boundaries and at house locations are shown in Appendix B. The 1/3rd octave analysis of the noise at the noise sensitive locations showed no significant peaks. The noise spectra were determined mainly by distant traffic.


38

Label Date Time2 Measured Noise Level dB(A)

Comments LAeq LA90 LA50 LA10 Specific1

Daytime

NSL1 26/8 14.15 57 49 52 61 <<49 Local and distant traffic, gardening works, plant noise not audible

NSL2 26/8 14.50 57 49 51 58 <<49 Local and distant traffic noise, plant not audible

NSL3 26/8 15.30 56 49 51 55 <<49 Local and distant traffic noise, plant not audible

B1 26/8 11.45 56 50 52 55 50 Low level plant noise, site traffic, distant traffic, short fire alarm test

B2 26/8 13.00 57 54 56 58 54 Low level plant noise, distant traffic

B3 26/8 12.25 59 57 59 61 <57 Constant traffic noise, plant barely audible

B4 26/8 12.15 61 56 58 60 <56 Constant distant traffic noise, lower level plant noise, occasional works and vehicles nearby

B5 26/8 11.55 62 59 61 64 <59 Constant traffic noise, plant barely audible, short fire alarm test

Nighttime NSL1 27/8 00.20 50 44 47 53 <44 Distant traffic, plant noise just audible NSL2 27/8 01.00 47 44 46 49 <44 Distant traffic, plant noise just audible NSL3 27/8 01.40 46 40 46 49 <<40 Distant traffic, plant noise not audible

B1 26/8 23.15 57 52 54 55 52 Distant traffic, plant noise

B2 26/8 23.35 60 59 60 61 60 Plant noise (sounded like high velocity extract or vent on top of Operations 1)

B3 26/8 23.45 60 58 60 62 60 Plant noise, from direction of Operations 1

B4 26/8 23.25 58 56 58 59 56 Plant noise, traffic B5 26/8 23.20 56 51 55 58 51 Traffic, low level plant noise

Table 5. Measured noise levels, Pfizer Little Island August 2010 1 The Specific Noise Level is the noise level attributable to Pfizer 2 Measurement period, 30 minutes at NSL’s and 15 minutes at boundaries


39

Compliance With IPPC Licence Noise Limits

Daytime Limit 55 dB(A) The daytime noise limit was complied with at all noise sensitive locations. The specific noise was <<49dB(A) at all three locations.

Nighttime Limit 45 dB(A) The nighttime noise limit was complied with at all noise sensitive locations. The specific noise ranged from <<40 dB(A) to <44 dB(A). Tonality/Impulsiveness There was no audible or measurable tonal or impulsive component in the noise at the noise sensitive locations.

COMPARISON WITH PREVIOUS SURVEYS

The results of noise surveys at Pfizer from 2005 to 2010 are presented in Table 6, and in Figure 2. The historical comparison is confined to nighttime specific noise levels, due to the difficulty detecting plant noise during the daytime surveys. The specific industrial noise level can vary from survey to survey due to weather conditions, plant operating conditions, measurement precision, and the technique used to extract the specific industrial noise component from the total ambient noise. The estimated industrial specific noise components at NSL1 to NSL3 were consistent with the levels measured in 2009. Noise levels at the plant boundaries were similar to levels measured in 2009. There is consequently no indication of any significant systematic change in overall noise emission from the site. The slight increase of 3 dB at B2 and B3 was due to a noise source near the top of operations 1. This source was not detectible at the noise sensitive locations, and it is concluded that the impact off-site is negligible.


40

Location Nov 2005

Dec 2006

May 2007

Aug 2008

May 2009

August 2010 Type Label Description

Noise Sensitive Location

NSL1 St. Lappan’s Place <<44 <<52 <<45 <<48 42 <44

NSL2 North Eske <<44 <<43 <<45 <<40 43 <44 NSL3 Factory Hill <<43 <<47 <<43 <<42 42 <<40

Boundary

B1 South East 55 <55 <53 53 52 52 B2 South West 53 <54 56 54 57 60 B3 North West 54 53 59 55 57 60 B4 North 56 59 58 57 60 56 B5 North East <59 54 <57 49 51 51

Table 6. Comparison of night-time specific noise levels, 2005 to 2010

Figure 2. Variation of specific noise levels at nearest houses to Pfizer, from 2005 to

2010

20

30

40

50

60

70

Nov 05 Dec 06 May 07 Aug 08 May 09 Aug 10

dB(A

) NSL1NSL2NSL3


41

APPENDIX A - TERMINOLOGY dB(A) a logarithmic noise scale, called the decibel. The "A" indicates that a

frequency weighting has been applied to take account of the variation in the sensitivity of the human ear as a function of frequency.

LAeq the average noise level during the measurement period. It includes all noise

events. The LAeq value has been found to correlate well with human tolerance of noise, and is the value normally used in setting and monitoring industrial noise limits.

LA90 the noise level exceeded for 90% of the time. It is generally taken as being

representative of the steady background noise at a location. It tends to exclude short events such as cars passing, dogs barking, aircraft flyovers etc., and provides a good estimation of steady plant noise, when there is significant interference from other noise sources

LA50 the noise level exceeded for 50% of the time. This statistical parameter provides

a good estimation of plant noise, when there is occasional intermittent interference from other noise sources

LA10 the noise level exceeded for 10% of the time, and is a measure of the higher

noise levels present in the ambient noise LAS, LAF the live displayed noise level, updated at 1 second intervals, measured with the

instrument’s response time set to standardised "Slow" or "Fast" response. The live meter reading provides survey personnel with corroborative data for determining the noise level due to a specific audible sound source. The highest value measured is termed LAmax, and the lowest level detected is termed LAmin.

Total Noise the overall noise level (LAeq), due to all noise noises (also termed ambient noise) Specific Noise a component of the total noise that can be quantified and attributed to a

specific source. Residual Noise the noise level that would exist in the absence of the specific noise source Noise Profile noise level logged at short intervals (10 second intervals in this survey).


42

Appendix B - Night-time Noise Spectra

NSL 3 Factory Hill 01.40

20

30

40

50

60

70

50 63 80 100

125

160

200

250

315

400

500

630

800

1K

1.25

K

1.6K 2K

2.5K

3.15

K

4K 5K

Frequency, Hz

dB (L

)

LeqL90

NSL1 St. Lappan's 00.20

20

30

40

50

60

7050 63 80 10

0

125

160

200

250

315

400

500

630

800

1K

1.25

K

1.6K 2K

2.5K

3.15

K

4K 5K

Frequency, Hz

dB (L

)

.

LeqL90

NSL 2 North Eske 01.00

20

30

40

50

60

70

50 63 80 100

125

160

200

250

315

400

500

630

800

1K

1.25

K

1.6K 2K

2.5K

3.15

K

4K 5KFrequency, Hz

dB (L

)

.

LeqL90

Traffic engine noise Traffic tyre &

aerodynamic noise


43

B1 23.15

20

30

40

50

60

70

50 63 80 100

125

160

200

250

315

400

500

630

800

1K

1.25

K

1.6K 2K

2.5K

3.15

K

4K 5K

Frequency, Hz

dB (L

)

LeqL90

B2 23.35

20

30

40

50

60

70

50 63 80 100

125

160

200

250

315

400

500

630

800

1K

1.25

K

1.6K 2K

2.5K

3.15

K

4K 5K

Frequency, Hz

dB (L

)

LeqL90

B3 23.45

20

30

40

50

60

70

50 63 80 100

125

160

200

250

315

400

500

630

800

1K

1.25

K

1.6K 2K

2.5K

3.15

K

4K 5K

Frequency, Hz

dB (L

)

.

LeqL90

Short duration unidentified noise

10 d


44

B5 23.20

20

30

40

50

60

70

50 63 80 100

125

160

200

250

315

400

500

630

800

1K

1.25

K

1.6K 2K

2.5K

3.15

K

4K 5K

Frequency, Hz

dB (L

)

LeqL90

B4 23.25

20

30

40

50

60

70

50 63 80 100

125

160

200

250

315

400

500

630

800

1K

1.25

K

1.6K 2K

2.5K

3.15

K

4K 5K

Frequency, Hz

dB (L

)

.LeqL90


45

2.9 Resource Consumption

A summary of energy and water consumption for 2007 is presented in Table 2.9.1 with comparative figures for the previous two years.

Year

Natural Gas

(MWh)

Electricity

(MWh)

Water (m3)

2008 16,389.09 1,214,281 890,000

2009 18,846,243 1,394,764 1,332,9631

2010 17,483,917 1,503,475 708,228

Table 2.9.1 Energy & Water consumption

Note 1 : Details on the decrease of water usage in 2010 are covered in the EMP – Report on the Progress made and proposals being developed to minimise water demand and the volume of trade effluent.


46

2.10.1. Energy Efficiency Audit Report Summary Audit Type System Audited/Surveyed Audit/Survey by Technical HVAC OP1 and OP2 Eirdata

Technical Compressed Air Leakage Survey&Repair

O Niell Indiustiral

Technical Durr Service report post Ceramic Exchange

Durr Gmbh

Technical Design/Feasibility of Splitting Chiller system (Ongoing)

CEL

Technical Boiler Efficiency Check Saacke

Technical Annual Energy Aspects Review Pfizer /RPS Internal Audit/Systems Internal Audit (EnMS Review) Pfizer/RPS – Internal

Audit Internal Audit/Systems Thermal Oxidiser Pfizer/RPS – Internal

Audit Internal Audit/Systems HVAC Pfizer/RPS – Internal

Audit

Internal Audit/Systems Chillers Pfizer/RPS – Internal Audit

Internal Audit/Systems Boilers Pfizer/RPS – Internal Audit

Internal Audit/Systems Compressed Air Pfizer/RPS – Internal Audit

Internal Audit/Systems PSA Plant Pfizer/RPS – Internal Audit

Table 2.10.2 The relevant environmental targets and objectives will be considered with respect to the recommendations of energy audits.


47

2.11 Environmental Incidents & Complaints Table 2.11.1 Environmental Incidents in 2010 Date Incident Detail Corrective Action 24/Feb/2010 Equipment Malfunction - Low flow readings from, flow meter

FT 500705 from the WWTP – PW 1. All discharges from PW1 are well within the IPPC licence limit of 1,000m3 / day, in the region of 300-400m3/day.

Root Cause: Instrument drift Preventative Action: Closely monitored and maintenance request to be issued in the event of any irregularity.

28/April/2010 Unexpected release Chlorine Leak- Emergency evacuation of the site due to a leak of chlorine in OP1, at a conc of 0.5ppm chlorine. Localised minor incident.

Root Cause: Leak from a butterfly valve and charge canister arrangement Preventative Action :A revised sequence of testing for leak tests on the valves was implemented.

26/ Nov /2010 Equipment malfunction Storm water TOC Biotectar analyser at SW2. All storm water was diverted to the firewater retention pond.

Root cause – Corrosion of tubing by acid Preventative Action : Corrosion resistant connections installed.

Table 2.11.2 Environmental Complaints 2010 Date Complaint Cause Corrective action N/A There were no environmental

complaints in 2010 N/A N/A

ANNUAL ENVIRONMENTAL REPORT 2009 ___________________________________________________________________________________

48

3.0 Environmental Management Programme Report

A report on progress on the 2010 Environmental Management Programme is shown in

the Appendix 2.


- 49 -

4.0 Pollution Release and Transfer Register Table 4.1 PRTR Table

The following substances are reported for 2010, through the EPA’s web-based reporting system. No. Substance

2 Carbon Monoxide (CO) 3 Carbon Dioxide (CO2) 6 Ammonia (NH3) 7 Non methane volatile

organic compounds 8 Nitrogen oxides

(NOx/NO2) 11 Sulphur Oxides (Sox/SO2) 12 Total Nitrogen 13 Total phosphorous 22 Nickel and compounds (as

Ni) 35 DCM 47 PCDD + PCDF (dioxins +

furans) as (Teq)(10) 73 Toluene 76 Total organic carbon (TOC)

(as total C or COD/3) 79 Chlorides (as total Cl) 80 Chlorine and inorganic

compounds (as HCL)


- 50 -

4.1 Proposal for Pollutant Release and Transfer Register (PRTR) Summary This proposal will outline the material to be reported in the Pollutant Release and Transfer Register (PRTR) covering the period January to December 2011. Introduction Under the E- Pollutant Release and Transfer Register Regulation (EC) no. 166/2006, which was brought under Irish law through S.I no. 123 of 2007, operators of activities shall annually report emissions to it’s competent authority. Under condition 6.14 of the IPPC licence “the licensee shall prepare and report a PRTR for the site. The substances and/or waste to be included in the PRTR shall be agreed by the Agency each year by reference to EC Regulation No.166/2006 concerning the establishment of the European Pollutant Release and Transfer Register and amending Council Directives 91/689/EEC and 96/61/EC. The PRTR shall be prepared in accordance with any relevant guidelines issued by the Agency and shall be submitted electronically in specified format and as part of the AER.” The PRTR, for January 2011 to December 2011 will be submitted to the Agency, electronically through the Agency’s web based system and also through the AER. The following substances, listed in PRTR are used/emitted from the site and the quantities of these materials emitted to air, water and sewer, as appropriate, will be reported. PRTR No. Pollutant 2 Carbon Monoxide (CO) 3 Carbon Dioxide (CO2) 6 Ammonia (NH3) 7 Non methane volatile organic

compounds 8 Nitrogen oxides (NOx/NO2) 11 Sulphur Oxides (Sox/SO2) 12 Total Nitrogen 13 Total phosphorous 22 Nickel and compounds (as Ni) 35 Chloromethane (DCM) 47 PCDD + PCDF (dioxins +

furans) as (Teq)(10) 73 Toluene 76 Total organic carbon (TOC) (as

total C or COD/3) 79 Chlorides (as total Cl) 80 Chlorine and inorganic

compounds (as HCL)


- 51 -

Data Determination The data for the PRTR will be obtained using the following methods: ° Measured ° Calculated ° Estimated Where possible, direct measurement will be used to determine emissions. But where this is not possible calculation and estimation techniques may also be required.


- 52 -

Proposals for AER period January to December 2011 Table 5.1 Objectives and targets

NO

OBJECTIVE

TARGET

DATE

1 To develop process modifications

which will allow for improved yields, the elimination / reduction of wastes and which will allow for the use of alternative less hazardous materials.

• Review solvent and water usage for the product Y process.

• Review solvent and water usage for the product X process

• Review solvent and water usage for the API process

• Replace the current product X and Y process with the product C process.

• Trial the treatment of product C aqueous brine streams in the WWTP

• Implement solvent recovery for raw material O1 and raw material A1 from the product C & product Z process for re-use on site.

Q3 2011

Q3 2011

Q3 2011 Q4 2011

Q3/Q4 2011

Q3/Q4 2011

2 To improve process control (equipment and management) in order to reduce

waste.

• Complete Installation of a solid waste compactor on site

Q2 2011

3 To maintain and calibrate key control

and monitoring equipment. • Install a spiral heat exchanger in the WWTP • Implement ppk tools for WWTP parameters

Q3 2011 Q2 2011

4 To improve treatment / abatement systems to reduce emissions.

• Install two weak stream upset lines Q3 2011

5 Reduction in fugitive emissions • Upgrade the OP1 vent header system • Reduce fugitive emissions using PAT

technology- On line sampling • Reduce fugitive emissions from products C and

Z by minimising IPT’s

Q2 2012 Q4 2011 Q4 2011

6 To prevent incidents with the potential for environmental consequences and to

prepare and implement contingency plans in the event of an emergency.

• Construct a dedicated storage area for acetic acid, caustic and nickel drums

• Maintain Emergency Management Team and Emergency Response Team training schedule

• Ensure integrity of bunded structures. • Complete repairs on liner in the firewater

retention pond

Q2 2011

2011

Q4 2011 Q1 2011

7 To identify savings in energy, water and material usage.

• Complete a feasibility study on the installation of a chilled water loop in OP1

• Investigate the installation of a VSD on the fixed speed compressors currently in operation.

• Energy Aspects Review ’10 and update EMP • Reduce airflow to FD5701 • Site-wide Energy Awareness Campaign • Complete test burn on boiler A with distillates • Configure CEMS & production for the use of

distillates as an alternative to gas in Boiler A.

Q1 2011

Q2 2011

Q1 2011 Q2 2011 Q2 2011

Q2 2011 Q3 2011

8 To improve site-wide environmental management in accordance with IPC

Licence, Corporate.

• Complete Environmental Site Management Review

• Participation in laboratory proficiency scheme

Q2 2011

Q4 2011


- 53 -

• Update the current laboratory management system to comply with ISO 17025

Q4 2011


- 54 -

5.2 Environmental Management Programme proposal

The proposal for the Environmental Management Programme proposal for 2011 is

shown in the Appendix 3 .


- 55 -

5.3 Noise monitoring programme proposal For the coming year we propose to measure noise levels at noise sensitive

locations. Readings will be taken during day-time and night-time conditions. We

also propose to take measurements at the boundary fence.

We will retain the services of an outside consultant to carry out this work.


- 56 -

Appendix

1. Ground Water Summary 2. Environmental Management Programme Report for 2010 3. Environmental Management Programme Proposal for 2011 4. Bund Integrity Report 5. Electronic PRTR 6. Review of Decommissioning Management Plan 7. Statement of Measures Covering Environmental Liabilities 8. Underground pipe line testing summary for 2010 9. Water demand and trade effluent generation minimisation

APPENDIX 1 Ground Water Summary Report for 2010


Pfizer Little Island IPPC Groundwater Monitoring Annual Groundwater Summary

Pfizer Ireland Pharmaceuticals\49342237 Pfizer Little Is GW 2010\CKRP0003/EO/EO

30 March 2011

Final

CKRP0003

Project Title: Pfizer Little Island IPPC Groundwater Monitoring

Report Title: Annual Groundwater Summary

Project No: 49342237

Report Ref: CKRP0003

Status: Final

Client Contact Name: Marian Slattery

Client Company Name: Pfizer Island Pharmaceuticals

Issued By: URS Ireland Acorn Business Campus Mahon Industrial Park Blackrock Cork Ireland Tel: 353.(0).21.453.61.36/37 Fax: 353.(0).21.435.06.66 (shared)

Document Production / Approval Record

Issue No: Name Signature Date Position

Prepared by

Trent Reed

30 March 2011

Senior Environmental Scientist

Checked by

Edel O'Hannelly

30 March 2011

Senior Hydrogeologist

Approved by

Kevin Forde

30 March 2011

Technical Director



30 March 2011

Page i

Final

CKRP0003

CONTENTS

Section Page No

1. INTRODUCTION.............................................................................................................. 1

2. GROUNDWATER MONITORING RESULTS.................................................................. 3

2.1 Volatile Organic Compounds (VOCs) .............................................................................. 3 2.2 Other VOC Results........................................................................................................... 6 2.3 Other Groundwater Results ............................................................................................. 7

3. DISCUSSION OF THE REMEDIATION PROGRAM ...................................................... 8

4. POTENTIAL IMPACT ON SURROUNDING ENVIRONMENT........................................ 9

5. CONCLUSIONS AND RECOMMENDATIONS ............................................................. 10

6. LIMITATIONS ................................................................................................................ 11

7. COPYRIGHT.................................................................................................................. 11

FIGURES

TABLES



30 March 2011

Page 1

Final

CKRP0003

1. INTRODUCTION

URS Ireland Ltd. (URS) are pleased to present the annual groundwater summary report

for 2010 detailing the groundwater monitoring program completed for the year at the

Pfizer Ireland Pharmaceuticals, Little Island API plant (Little Island). This summary report

has been completed in accordance with URS Proposal 3077859 and authorised by Pfizer

under their purchase order number N-2164264, dated 10 March 2010.

The round 1 (April) 2010 groundwater monitoring program comprised sampling of the

following fifteen wells:

• 200 series wells – 201, 202, 203, 205A, 206 and 207;

• 300 series wells – 301, 302, 303, 304 and 305;

• 400 series wells – 403, 404 and 405; and

• 500 series wells – 501.

In May 2010, the EPA agreed to remove wells 403 and 501 from the sampling schedule

and requested that wells 206 and 303 be monitored every two years, as opposed to

biannually.

As such the monitoring round 2 (October) 2010 program was reduced and comprised

sampling of the following eleven wells:

• 200-series wells – 201, 202, 203, 205A and 207;

• 300-series wells – 301, 302, 304 and 305; and

• 400-series wells – 404 and 405.

Groundwater samples from the wells were submitted for analysis of the following

parameters (as outlined in Pfizer Little Island’s IPPC licence):

• Volatile Organic Compounds (US EPA 524.2 by GC-MS); and

• Semi-volatile Organic Compounds (US EPA 524.2 by GC-MS).

Groundwater samples from the 200- and 300- series wells were also submitted for

analysis of the following parameters (as outlined in Pfizer Little Island’s IPPC licence):

• Major Ions (sodium, potassium, magnesium, calcium, sulphate, total alkalinity,

chloride and nitrate).

The sample schedule for 2010 is presented in Table 1.



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The following parameters were measured in the field at each well to comply with licence

requirements:

• pH;

• Electrical conductivity;

• Temperature; and

• Dissolved oxygen.

The findings of the 2010 groundwater monitoring programme for the Pfizer Little Island

site are summarised in the following sections of this report.



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2. GROUNDWATER MONITORING RESULTS

Table 1 presents an inventory of samples taken throughout 2010. Figure 1 shows the

locations of monitoring wells at the Pfizer Little Island site.

2.1 Volatile Organic Compounds (VOCs)

MTBE and Toluene

MTBE and toluene have been the principal contaminant compounds of concern at the

Pfizer Little Island site.

Toluene was not detected above the laboratory method detection limit (MDL) in the

groundwater samples collected in 2010.

MTBE was detected in groundwater from several wells, however, concentrations are

following declining trends, with the result that the Draft IGV for MTBE (0.03 mg/L) was

exceeded by only one well in October 2010 (well 203).

Table 2 presents the results for toluene and MTBE for key wells in 2010 and significant

contaminant trends for each well in 2010 are summarised below.

Well 201

Well 201, screened within the sand and gravel aquifer was sampled in April and

October 2010.

During 2010, MTBE concentrations in groundwater from well 201 remained considerably

below the Dutch Intervention Value (DIV) for MTBE of 9.2 mg/L and the Draft IGV of

0.030 mg/L. The MTBE concentration remained relatively static at 0.018 mg/L in April

2010 and 0.010 mg/L in October 2010, the lowest MTBE result in this well since

monitoring began. MTBE concentrations in groundwater from well 201 have been below

0.020 mg/L since March 2009.

Well 202

Well 202, screened within the sand and gravel aquifer, was sampled in April and

October 2010.

The MTBE concentration in groundwater from well 202 was 0.006 mg/L in April 2010, it’s

lowest concentration to date for this well. The MTBE concentration increased slightly to

0.009 mg/L in October 2010. Since August 2008, MTBE concentrations from well 202

have generally been below the Draft IGV of 0.030 mg/L.

Well 203

Well 203, screened within the sand and gravel aquifer, was sampled April and

October 2010.



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The MTBE concentration in groundwater from well 203 decreased to 0.062 mg/L in

October 2010, compared to 0.256 mg/L in April 2010. While the MTBE concentration

remains marginally above the Draft IGV (0.030 mg/L), it has been below the DIV since

September 2006.

Well 205A

Well 205A, screened within the sand and gravel aquifer, was monitored in April and

October 2010.

For the first time since a peak concentration of 28.75 mg/L was reported in May 2006, the

MTBE concentration in groundwater from well 205A was below the Method Detection

Limit (MDL, 0.001 mg/L) in April 2010 and remained so in October 2010. MTBE at well

205A has been below the DIV since December 2006.

Well 206

Well 206, screened within the sand and gravel aquifer, was monitored in April 2010.

MTBE was not detected above the MDL (0.001 mg/L) in groundwater from well 206 in

2010.

Well 207

Well 207, screened within the sand and gravel aquifer, is located up-gradient of the

majority of the Little Island API site and was monitored in April and October 2010.


2010.

Well 301

Well 301, screened within the sand and gravel aquifer, was monitored in April and

October 2010.

Groundwater from well 301 recorded MTBE concentrations of 0.018 mg/L and

0.005 mg/L in April and October 2010, respectively. In 2010 MTBE concentrations

declined below 0.010 mg/L for the first time since 2005. MTBE concentrations have not

exceeded the Draft IGV (0.030 mg/L) since March 2008.

Well 302


October 2010.

The MTBE concentration in groundwater from well 302 decreased slightly from

0.040 mg/L in April 2010 to 0.022 mg/L, reducing below the Draft IGV (0.030 mg/L).



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Well 303

Well 303, screened within the sand and gravel aquifer, was monitored in April 2010.


2010.

Well 304


October 2010.

The MTBE concentration in groundwater from well 304 decreased from 0.005 mg/L in

April 2010 to 0.004 mg/L in October 2010. MTBE concentrations in groundwater from well

304 have declined (compared to monitoring results from 2008 and 2009) and have been

below the DIV (9.2 mg/L) since December 2005. 2010 was the first year since monitoring

began that MTBE concentrations have been below the draft IGV (0.030 mg/L) for the full

year.

Well 305

Well 305, screened within the sand and gravel aquifer, was sampled in April and

October 2010.

MTBE increased from below the reporting limit (0.001 mg/L) in April 2010 to 0.007 mg/L

in October 2010 in groundwater from well 305 (below the Draft IGV of 0.030 mg/L).

Well 403

Well 403, screened within the (former) perched aquifer, was sampled in April 2010. The

well is frequently dry, as was the case throughout 2008 and in March 2009. Well 403 was

also sampled in September 2009.

MTBE was detected in groundwater from well 403 at a concentration of 0.015 mg/L

(below the Draft IGV of 0.030 mg/L).

Well 404

Well 404, monitoring a localised area of low permeability ground close to the former

location of Sump G, was sampled in April and October 2010.

At well 404 MTBE concentrations declined, compared to 2009 results. The MTBE

concentration declined to 0.572 mg/L in April 2010 and was below the MDL in October

2010. The 2010 results in well 404 are among the lowest on record for this well, as

MTBE concentrations had exceeded the DIV in the three monitoring rounds from

November 2008 to March 2009 and was above the draft IGV to April 2010.



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Well 405

Well 405 was sampled in April and October 2010.

The MTBE concentration in groundwater from well 405 decreased to 0.004 mg/L in

October 2010 from 0.005 mg/L in April 2010. MTBE concentrations from well 405 have

been below the DIV since April 2007 and were below the Draft IGV (0.030 mg/L)

throughout 2010.

Well 501

Well 501, in the (former) perched aquifer, was sampled in April 2010, historically the well

has frequently been dry.

In April 2010, MTBE was detected in groundwater from well 501 at a concentration of

0.003 mg/L, unchanged from the September 2009 monitoring result and below the Draft

IGV (0.030 mg/L).

2.2 Other VOC Results

Several other VOCs (chloroform, 1,2-dichlorobenzene and 1,1,1-trichloroethane) were

detected in groundwater in 2010 at isolated locations and generally at trace (<0.020

mg/L) concentrations. The majority of other VOCs were below the relevant reporting

limits.

Chloroform was detected in groundwater from four wells 206, 207, 403 and 404 in April

2010 and in wells 207 and 404 in October 2010. The majority of chloroform

concentrations were <0.010 mg/L. Chloroform concentrations above the Draft IGV

(0.012 mg/L) were recorded in groundwater from well 403 (0.020 mg/L) in April 2010 and

well 404 (0.087 mg/L) in October 2010. Chloroform had previously been detected in

these wells in September 2009, with the concentrations declining in 2010.

Chloroform concentrations in groundwater from up-gradient boundary well 207 are low

but stable, and suggest a source that is off-site and up-gradient of the Pfizer Little Island

facility. However, the detections at wells 403 and 404 may indicate a residual shallow

source in the former perched groundwater horizon.

1,2-Dichlorobenzene was detected at trace concentrations in groundwater from well 202

(0.004 mg/L) in April 2010.

The October 2010 monitoring recorded detections of 1,1,1-trichloroethane in groundwater

from one well, 404 (0.006 mg/L). This concentration does not exceed any defined

threshold for 1,1,1-trichloroethane. 1,1,1-Trichloroethane has historically been

intermittently detected at trace levels in groundwater from the site.

The majority of other VOCs were below the relevant MDLs in 2010 monitoring.



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2.3 Other Groundwater Results

No significant detections of semi-volatile organic compounds, alcohols, major ions or

groundwater chemistry parameters were recorded during groundwater sampling at the

Little Island API facility in 2010.



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3. DISCUSSION OF THE REMEDIATION PROGRAM

A remediation system consisting of pumps in wells 403 and 404 was installed in April

2003 at the Little Island site. At the time it was designed to remove MTBE and toluene

contaminated groundwater from the perched aquifer in the Old Aeration Basin and

discharge it into the site effluent drainage system.

Well 501 was added to the pumping programme in July 2004 and proved to be the most

productive of the three pumping wells. Pumping from well 501 ceased in March 2006 due

to repeated calcium sulphate encrustation, once the well pH declined from initially

elevated levels.

Various leaks in the weak and strong stream effluent system have historically contributed

to the elevated MTBE concentration in well 404. Due to the impermeable soils around

well 404, the removal of this material by pumping was slow, however the contamination

appeared to be localised.

By the end of 2007, given the general improvement in groundwater quality in the former

Aeration Basin area of the site, due to infrastructural upgrades to the site drainage

systems and, the groundwater remediation system was no longer considered necessary.

The excavation for the new weak stream tank in the Old Aeration Basin area in early

2008 breached the basal clay layer and consequently a perched aquifer no longer exists

in this area of the site, wells screened within the former perched aquifer (wells 403 and

501) are frequently dry.

Increased MTBE concentrations were recorded for well 404 in 2008 (relative to the low

results in mid-late 2007) however these declined during 2009 and 2010, with MTBE

below the MDL in well 404 in October 2010. The elevated MTBE detections in this well in

2008 may have been due to ground disturbance during installation of the nearby weak

stream tank, as groundwater in well 404 likely represents localised perched groundwater

present in a pocket of lower permeability sub surface soils.

To date, there is no evidence that the increase in MTBE in well 404 in 2008 has had any

impact on the wider groundwater quality, with concentrations declining site-wide during

2009 and 2010 in the main aquifer.



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4. POTENTIAL IMPACT ON SURROUNDING ENVIRONMENT

Groundwater from the site discharges to Bury’s Bridge Basin, a shallow tidal inlet of

Lough Mahon (upper part of Cork Harbour). The basin comprises of a mudflat, and a

narrow intertidal channel. It was designated as a National Heritage Area on the basis of

its importance as a heronry. However, this part of Cork Harbour has subsequently been

heavily industrialised, having been substantially modified by infilling and reclamation for

industry and road developments (unpublished information from National Parks and

Wildlife Service). The building of the Lee Tunnel, which passes within 500 metres of the

basin, is thought to have caused further changes to the area.

Bury’s Bridge Basin is not considered to have any significant sea fishery resources based

on the scale of industrialisation that has occurred in the area, but mudflats in areas of the

basin could host a diverse shellfish population, which are not known to be exploited

commercially.

A literature review and the ecotoxicology testing carried out by URS in December 2000

showed that MTBE is a low toxicity contaminant with respect to aquatic organisms. The

MTBE concentrations observed in 2000, and the likely worst-case concentrations

predicted in Bury’s Bridge Basin, were 10 to 1000 times lower than the acutely toxic

concentrations. In addition, MTBE does not cause long-term genetic effects at low

concentrations and does not bioaccumulate in the food chain.

Therefore, the migration of MTBE into Bury’s Bridge Basin at the prevailing groundwater

concentrations in 2000 was not considered to be of ecological concern to the aquatic life

and bio-diversity in the basin and no additional groundwater controls were deemed

necessary at the site to protect the exposed receptors.

Risk assessment modelling (November 2002) showed that the ‘worst case’ groundwater

MTBE contamination reaching Bury’s Bridge Basin posed an insignificant risk to surface

water quality in the basin via groundwater transport in the gravel aquifer.

The 2010 data for MTBE in groundwater from wells 301 and 302 (the wells closest to

Bury’s Bridge Basin) are significantly lower than the 2000 data on which the risk

assessment was based and do not indicate that this conclusion needs to be revised.



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5. CONCLUSIONS AND RECOMMENDATIONS

The main conclusions of the 2010 groundwater monitoring programme at the Pfizer Little

Island API facility are as follows:

• MTBE is the only remaining compound of concern in groundwater at the Pfizer Little

Island site (with an exceedence of the Draft IGV in groundwater from only one well,

203, in October 2010).

• Concentrations of MTBE have declined significantly in recent years, following

infrastructural improvements.

• The MTBE concentration in groundwater from well 404 declined in 2010 (compared

to 2008 and 2009 results) and was below the MDL in October 2010. This suggests

that the elevated concentrations in 2008 were due to localised disturbance in this

area during engineering works in early 2008.

• The risk posed to down-gradient receptors (i.e. Bury’s Bridge Basin) by the

contamination in the former Aeration Basin area is considered to be negligible,

based on the November 2002 risk assessment modelling and on the subsequent

significant decline in both toluene and MTBE concentrations in groundwater at the

site.

• Toluene concentrations were below reporting limits in all groundwater samples at

the site in 2010.

• As in 2009, chloroform was detected in four wells in 2010. The 2010 chloroform

concentrations in the wells are lower than the 2009 results and also generally below

the Draft IGV.

• Other VOCs are detected in groundwater, but are generally isolated detections at

trace concentrations.

• The wells should be monitored in 2011 in accordance with the schedule set out in

Section C.6 of the site’s revised IPPC Licence (No. P0136-04, dated 07 January

2011), as follows:

o Monitored on a biannual basis for pH, temperature, dissolved oxygen,

conductivity, major anions and cations, volatile and semi volatile organic

compounds:

− 200 series wells - 201, 202, 203, 205A, and 207; and

− 300 series wells - wells, 301, 302, 304 and 305.

o Monitored biannually for volatile and semi volatile organic compounds only.

− 400 series wells - 404 and 405 (if groundwater is detected).



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6. LIMITATIONS

URS Ireland Limited (URS) has prepared this Report for the sole use of Pfizer Island

Pharmaceuticals in accordance with the Agreement under which our services were

performed. No other warranty, expressed or implied, is made as to the professional

advice included in this Report or any other services provided by us. This Report may not

be relied upon by any other party without the prior and express written agreement of

URS. Unless otherwise stated in this Report, the assessments made assume that the

sites and facilities will continue to be used for their current purpose without significant

change. The conclusions and recommendations contained in this Report are based upon

information provided by others and upon the assumption that all relevant information has

been provided by those parties from whom it has been requested. Information obtained

from third parties has not been independently verified by URS, unless otherwise stated in

the Report.

Where field investigations have been carried out, these have been restricted to a level of

detail required to achieve the stated objectives of the services. The results of any

measurements taken may vary spatially or with time and further confirmatory

measurements should be made after any significant delay in using this Report.

7. COPYRIGHT

© This Report is the copyright of URS Ireland Limited. Any unauthorised reproduction or

usage by any person other than the addressee is strictly prohibited.



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Figures

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GROUNDWATER MONITORING WELL

INACCESSIBLE GROUNDWATER MONITORING WELL

E N V I R O N M E N T A L C O N S U L T A N T S

Job No. SCALE

TRACED CHECKED

REV.

DRAWN APPROVED

SML DATE

A

07.02.11

Key CLIENT

PROJECT LOCATION

DRAWING TITLE

EF EO’H/COR

49342237AS SHOWN

North

PFIZER IRELAND PHARMACEUTICALS

LITTLE ISLAND, CORK

FIGURE 1 - SITE PLAN AND WELL LOCATION MAP

ACORN BUSINESS CAMPUS,MAHON INDUSTRIAL PARK, BLACKROCK, CORK

TEL: 00 353 (0)21 4536136 FAX: 00 353 (0)21 4350666



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CKRP0003

Tables

Table 1

Sampling Schedule for Pfizer Little Island 2010

LocationMonitoring

Well ID

Screen

Interval

(m)

Apr-10 Oct-10

201 6.0-10.0 O O

202 6.0-10.0 O O

203 4.5-10.0 O O

205A 3.4-7.4 O O

206* 7.0-13.0 O N/A

207 10.5-13.5 O O

301 6.0-10.0 O O

302 2.0-7.0 O O

303* 3.2-6.2 O N/A

304 5.6-9.6 O O

305 2.9-6.9 O O

403^ 1.5-3.0 X N/A

402 5.0-6.5 N/A N/A

404 1.7-4.7 X X

405 5.1-6.1 X X

501^ 2.1-4.1 X N/A

502 5.3-6.8 N/A N/A

503 2.1-4.1 N/A N/A

N/A = Not analysed

* As agreed with the EPA (May 2010), wells 206 and 303 will be monitored biennially, next monitoring round April 2012

^ As agreed with the EPA (May 2010), wells 403 and 501 were removed from monitoring schedule

200-Series

Wells

Major Ions, Electrical Conductivity, Dissolved Oxygen, Temperature and pH.

300-Series

Wells

Notes

400-Series

Wells

"O" = Full suite to be analysed on a biannual basis, to include VOCs, semi Volatile Organic Compounds (sVOCs),

"X" = Volatile Organic Compounds (VOCs) semi Volatile Organic Compounds (sVOCs),and pH only to be anaylsed.

500-Series

Wells

URS Ireland Ltd J:\Cork-Jobs\Pfizer Ireland Pharmaceuticals\49342237 Pfizer Little Is GW 2010\Technical\2010 GW AER\Table 1 Sampling Schedule 2010.xls

Table 2 - Key Contaminant Concentration Trends in Monitored Wells (mg/L), Pfizer Little Island,

2010

Apr-10 Oct-10 Apr-10 Oct-10

201 402

MTBE 9.200 0.018 0.010 MTBE 9.200 ns ns

Toluene 1.000 - - Toluene 1.000 ns ns

202 403

MTBE 9.200 0.006 0.009 MTBE 9.200 0.02 ns

Toluene 1.000 - - Toluene 1.000 -

203 404

MTBE 9.200 0.256 0.062 MTBE 9.200 0.572 -

Toluene 1.000 - - Toluene 1.000 - -

205A 405

MTBE 9.200 - - MTBE 9.200 0.005 0.004

Toluene 1.000 - - Toluene 1.000 - -

206 501

MTBE 9.200 - ns MTBE 9.200 0.003 ns

Toluene 1.000 - ns Toluene 1.000 - ns

207 502

MTBE 9.200 - - MTBE 9.200 ns ns


301 503

MTBE 9.200 0.018 0.005 MTBE 9.200 ns ns


302

MTBE 9.200 0.040 0.022 Notes:

Toluene 1.000 - - ns Indicates well not sampled

303 BOLD Indicates result above DIV

MTBE 9.200 - ns

Toluene 1.000 - ns

304

MTBE 9.200 0.005 0.004

Toluene 1.000 - -

305

MTBE 9.200 - 0.007

Toluene 1.000 - -

- Indicates result below method reporting limit

Monitoring RoundWell / VOC DIV Well / VOC DIV

Monitoring Round

URS Ireland Limited J:\Cork-Jobs\Pfizer Ireland Pharmaceuticals\49342237 Pfizer Little Is GW 2010\Technical\2010 GW AER\Table 2 Key Contaminant Trends 2010.xls

APPENDIX 2 EMP – Environmental Management Programme Report for 2010


ENVIRONMENTAL MANAGEMENT PROGRAMME REPORT 2010 .

- 1 -

1.0 INTRODUCTION

The Environmental Management Programme, incorporating the schedule of objectives and targets, is prepared in accordance with the requirements of Condition 2 of Pfizer Ireland Pharmaceuticals, Little Island’s Integrated Pollution Control Licence (Reg. No. 136-03). Cognisance has also been taken of the sections relating to the preparation of EMPs contained in the EPA’s Guidance Note for Annual Environmental Reports.

2.0 ENVIRONMENTAL MANAGEMENT PROGRAMME

This section sets out the Environmental Management Programme for Pfizer Little Island. The programme is broken down into a number of categories as follows:

1. Process modifications resulting in elimination or reduction of wastes or the use of alternative less hazardous materials

2. Improved process control to reduce waste

3. Maintenance and calibration of key control and monitoring equipment

4. Use and Improvements in treatment / abatement systems to reduce emissions

5. Recovery, reuse, recycling of waste material both on-site and off-site

6. Reduction in fugitive emissions

7. Prevention of incidents with the potential for environmental consequences

8. Savings in energy, water and material usage

9. General environmental management

For each of these headings, the following information is outlined:

• Objective

• Rationale behind the objective

• Specific targets to achieve the objective

• Plan to achieve the targets

• Timescale

• Persons responsible

ENVIRONMENTAL MANAGEMENT PROGRAMME REPORT 2010 .

- 2 -

1.0 Objective

To develop process modifications which will allow for improved yields, the elimination / reduction of wastes and which will allow for the use of alternative less hazardous materials.

Rationale:

Pfizer is committed to improving yields, elimination or reduction of wastes and / or the use of alternative less hazardous materials both at a Corporate and local level. This process is implemented at the earliest stage (by the Technical Services Department) of the process transfer to the plant. Specific requirements relating to the efficiency in use of raw materials and the reduction in waste generated are contained in Pfizer Little Island’s IPPC Licence (Reg. No. 136-03).

No.

Target

Plan/ Update

Responsibility

Timescale

1.1 Review solvent and water usage in the product Y process

Optimisation of PRODUCT Y process: (1) Trial the treatment of 3 aqueous waste streams to the WWTP, if successful facilitate continuous treatment of these streams on site. (2) Investigate the feasibility of increasing the PRODUCT Y raw materials by 10% while utilising the same conc of solvents and water. (3) Complete a mass balance on the PRODUCT Y process to minimise loss and optimise yield. Update :1) Batch record updated to enable Cuno Rinse Stream to go to strong stream 2) Trials on 10% increase were unsuccessful 3) Green Belt was carried out to optimise yield. As a consequence Yield increase was delivered ~1.5%.

(1) P Lang (Production) & MS (EHS) (2&3) TS (Leo Ryan)

Q3 2010

1.2 Review solvent and water usage in the product X process

Identify and implement potential changes to reduce solvent and water usage in the PRODUCT X process: (1) Investigate the feasibility of a 5% increase in PRODUCT X raw materials while utilising the same conc of solvents and water (2) Investigate further the feasibility of recovering and reusing toluene from the PRODUCT X process on site (As covered in 5.2 ) Update: 1) Implemented on site, 2) Raw material O1 lab trials completed and not possible to recover on site. Approx 300 tons of raw material O1 was sent to Ringaskiddy for Recovery from September of 2010.

(1& 2) L.Ryan (TS) Q3 2010

3

No.

Target

Plan/ Update

Responsibility

Timescale

1.3 Review solvent and water usage in the product A &Z process

Identify and implement potential changes to reduce solvent and water usage in the API process: (1) Investigate the feasibility of reducing the raw material A1 charged to PRODUCT X by 10-25%. (2) Investigate the feasibility of reducing the volumes of cleaning solvents by 10-20% Update: 1) Trials in laboratory successful, implemented on plant in Sept approx 30% reduction in the second charge of raw material A1 . 2) Study completed and implemented a reduction of approx 300l/batch of raw material Z for cleaning.

TS (C Brack) Q4 2010

.4 Upscale and validate the new product C and Z process. Optimise yields, solvents and raw material usage to minimise the volumes of waste generated and maximise waste that can be treated on site.

(1) Complete scale up of Step 2 and Step 3 of the new product Z process (2) Investigate the feasibility re-using raw material O1 in the new product C process (3) Investigate the feasibility of on-site treatment of brine waste stream Update ; 1) The product C step was validated in Group 4. The product Z validation campaign was put on hold as the first two batches did not filter well. The investigation and the validation will be completed once this investigation is completed and remedial measures put in place. 2) Trials on re-using the raw material O1 stream were unsuccessful. Trials undertaken by PDC on recovering and using the material have been favourable further work ongoing . 3) Pilot studies in treating of brine streams in the WWTP have been undertaken. Plant modifications are in progress – to facilitate the treatment of product X and Yes streams in the WWTP. It is expected that approx 61 tons per month of waste will be sent to the WWTP instead of disposal off site.

(1 & 2) B Pyne (TS), 3 T&I team

Q4 2011

4

5

2.0 Objective

To improve process control (equipment and management) in order to reduce waste.

Rationale:

The introduction of new equipment (e.g. automated control systems and monitoring equipment) and management tools will improve process control at Pfizer Little Island and will contribute to the reduction of waste.

No.

Target

Plan

Responsibility

Timescale

2.1 Reduce the volume of non hazardous material being sent off site for landfill. Optimise recycling opportunities on site

Complete an audit with Veolia on site to identify target areas where opportunities to optimise waste segregation and recycling can be undertaken. Update : Complete 29th March 2010. Compost bin to be placed in canteen to ensure site wide compostable waste is disposed of appropriately.

T. O'Leary & Veolia Q1 2010

2.2 Reduce the volume of liners and PPE waste sent off site

Install a solid waste compactor on site, this will maximise the volume of liners and PPE sent out per load and reduce the volume of packaging for same. Update: The compactor has been delivered to the site, installation and commissioning are complete, Review of waste stream suitability to be completed in 2011.

M Maguire (EHS) Q2 2010

2.3 Reduce the volume of waste drums sent off site

Install a drum washer and crusher on site, this will maximise the volume of waste drums sent out per load, thereby reducing the number of loads from the site. Update: This project will not be progressed at this stage, due to excessive costs.


6

3.0 Objective

To maintain and calibrate key control and monitoring equipment.

Rationale:

Specific requirements relating to the maintenance and calibration of key control and monitoring equipment are contained in Pfizer Little Island’s IPC Licence (Reg. No. 136-03).

No.

Target

Plan

Responsibility

Timescale

3.1 Optimise the effective operation of the Durr Thermal Oxidiser

As part of shut down complete a full maintenance exercise on the TO. Update: Maintenance programme completed.

M Madigan (Utilities) Q3 2010

3.2 Optimise operations and monitoring at the South Monitoring Station for Storm Water

Investigate the feasibility of upgrading the current Shimadzu TOC analyser on the South monitoring location for storm water Update : Investigation Complete, 5 Actions Identified, 4 Completed Alarm to be configures to the EHS operators pager in the event of a fault on the TOC analyser – Expected Completion date Q2 2011.

C Scully (EHS) Q3 2010

7

4.0 Objective

To improve treatment / abatement systems to reduce emissions.

Rationale:

The evaluation of environmental impacts has identified aqueous emissions as significant for the site. In addition, specific requirements relating to the improvement of treatment / abatement systems are contained in Pfizer Little Island’s IPPC Licence (Reg. No. 136-03)

No.

Target

Plan

Responsibility

Timescale

4.1 Optimise operation of WWTP to optimize performance

Complete the Six Sigma project initiated in 2009 : The project is currently in the data analysis phase, identifying key parameters that have a high influence on WWTP performance. Sampling completion, data analysis and implementation of improvements (Electricity and consumable consumption) will be undertaken. Update: The Six Sigma project initiated in 2009 is now completed having achieved it’s goals: With the introduction of State Point Analysis all 2050 polymer usage has been stopped since 01/March/2010. A 45kW Jet Mixing Pump PU 1037 which fed the Aeration Basin (AB1) manifold, was switched off as part of the Aeration Basin 1 bypass in August 2010. The associated motor MT 1037 was measured to be using 45 kW and was running 24/7 for 365 days a year. Aeration Electricity Usage. A smaller blower (55kW) was installed in place of the original 160kW blower The combined electricity reduction is equivalent to an annual reduction of 647 Tonnes of Carbon Dioxide to the atmosphere.

S O'Grady (RFT) Q3 2010

8

No. Target Plan Responsibility Timescale 4.2 Reduce the volume of storm water being

treated in WWTP Complete a feasibility study on the sending of bund material to storm water as per the low risk bunds identified in the assessment completed in 2009. Update : Complete – Estimated Cost 22,000€ works will not be progressed at this time.

M Slattery (EHS) Q 4 2010

4.3 Provide weak stream diversion options to Fire Water retention Pond and old weak stream tank

Install two weak stream upset lines from weak stream tank TK-230304 in Bund 517 and one to the Firewater Retention Pond & the Old Weak Stream tank TK-1135. This ensures that if there is a chemical spill onsite of concentrate material that enters the site weak stream drainage system, there are options available to divert this from the WWTP for more appropriate treatment. Update : CPA approved expected start date Feb 2011.

Projects Engineering (G Mc Namara)

Q 4 2010

5.0 Objective

To develop the use of alternative treatment / abatement systems to reduce emissions.

9

Rationale:

Specific requirements relating to the use of alternative treatment / abatement systems are contained in Pfizer Little Island’s IPPC Licence (Reg. No. 136-03).

No.

Target

Plan

Responsibility

Timescale

5.1 Recover raw material V from the PRODUCT X process

Investigate the feasibility of recovering the raw material V from the PRODUCT X waste stream and re-using in the PRODUCT X process. Update : Current plant set up does not lend itself to recovery of raw material V. However, trials off-site using this material as a waste with Sita Ecoservices, have been successful. The site has been audited and the process of approval for use by Pfizer corporate is ongoing.

L Ryan (TS) Q 2 2010

5.2 Recover and re-reuse raw material O1 in the new product A Process

Investigate the feasibility of recovering off site and re-using the raw material O1 waste stream in the product C process Raw material O1 lab trials completed and results are favourable, potential implementation in Q4 2011. (Recovery in Ringaskiddy). This timeline has moved out due to the moving out of the commercial manufacture of product C and Z.

B Pyne (TS) Q4 2010

10

6.0 Objective

To develop a programme for the reduction of fugitive emissions

Rationale:

Specific requirements relating to the reduction of fugitive emissions are contained in Pfizer Little Island’s IPPC Licence (Reg. No. 136-03).

No.

Target

Plan

Responsibility

Timescale

6.1

Reduce the fugitive emissions generated from storage tanks and vessels in operation on site

Complete a leak survey on OP3, OP2 and OP1 and the tank farm; Update: OP3, OP2 & Tank farm done this year (a number of N2 PCV’s have been repaired/replaced – particularly outside after the harsh winter) 1 tank to check during shutdown in tank farm as it is tied into TO header

E Creedon (Engineering)

September 2010

6.2

Reduce the number of bypass events on the thermal Oxidiser

Continuously monitor and evaluate the root cause of thermal oxidiser bypasses events in an attempt to reduce the number of bypass events Update: Ongoing TO bypasses Q1 – 2, Q2 -8, Q3 -5, Q4 -4.

S O'Brien (Production ) E Callery (EHS )

Ongoing

6.3

Reduce fugitive Emissions from the product X and Yes Process

Minimise fugitive losses by completing on line testing, complete temporary or permanent installation of 4 systems which will eliminate the need for sampling. Update : 100% Complete. Of 14 IPT tests identified, PAT for 5 has been identified as suitable, 3pH, and 2 assays. Implementation of these projects is complete.

PMc Gauley (T&I) Q3 2010

11

No.

Target

Plan

Responsibility

Timescale

6.4

Reduce fugitive Emissions from the product C and Z Process

Minimise fugitive losses by completing on line testing, complete feasibility study on 5 systems and complete installation of 5 temporary or permanent systems which will eliminate the need for sampling. Update :PO approved and order in place purchase PAT technology to use in conjunction with current PAT technology as part of an overall project to eliminate in process testing and associated sampling for the process

PMc Gauley (T&I) Q3 2011

6.5

Minimise the potential of fugitive emissions from HCL and caustic lines on sites

Upgrading of the older caustic and HCL pipework to 316L stainless Steel and PTFE Lined carbon steel from polypropylene & carbon steel pipe work. Update: 100% Complete.

G Mc Namara (Engineering)

December 2010

12

7.0 Objective

To prevent incidents with the potential for environmental consequences and to prepare and implement contingency plans in the event of an emergency.

Rationale:

Pfizer are committed to maintaining plans and procedures to identify the potential for and respond to incidents and emergency situations and for predicting and mitigating the environmental impacts that may be associated with them. In addition, specific requirements relating to the prevention of incidents with the potential for environmental consequences are contained in Pfizer Little Island IPPC Reg. No. 136-03).

No.

Target

Plan

Responsibility

Timescale

7.1 Ensure site is prepared in the event of an emergency

Maintain Emergency Management Team and Emergency Response Team training schedule Update: 5 ERT shift sessions completed, and 1 EMT sessions completed.(Annual Cost over 100,000€)

EHS (D.O'Herlihy) Continuous

7.2 To develop a programme for testing the integrity and water tightness of all bunding structures on site

Continue programme for testing integrity and water tightness of all bunding structures on site. Update: 100% Complete

EHS (M.Slattery) Continuous

7.3 Reduce the number of TOC diversions on the storm water system

The LTC cooling system in was identified as the main contributor to TOC diversions in 2009. It is now planned to narrow down the key vessels and processes which contribute to the TOC diversions Update: System installed to collect samples form diversions. Project plan in place to blow down jacket residues from key vessels to weak stream if successful programme will be rolled out to all key reactors. Significant reduction in storm water diversions from June to Dec (Approx 90 %)

M.Slattery (EHS) , S.O'Brien (Production), G. O'Riordan (RFT)

July 2010

13

No. Target Plan Responsibility Timescale 7.4 Test the integrity of the fire water retention

pond Complete repairs identified in 2009 and carry out spark testing. Update: Work 70% complete, expected completion due to unsuitable weather conditions (Frost & rain) this work has to be moved out to Q1 2011

B. Minehane (Engineeing)

June 2010

7.5 Install level indication on Fire Water retention Pond

Manufacture and install a level indicator on the Fire Water Retention Pond so as to enable accurate visual determination of capacity Update: Complete


June 2010

14

8.0 Objective

To identify savings in energy, water and material usage.

Rationale:

The evaluation of environmental impacts has identified energy and water use as significant for the site. In addition, specific requirements relating to the identification of savings in energy and material usage are contained in Pfizer Little Island’s IPPC Licence (Reg. No. 136-04).

No.

Target

Plan

Responsibility

Timescale

8.1 Reduce the volume of once through cooling water used on site

Complete the replacement of cooling water to OP3 with a closed recirculation cooling water loop. Update : Complete


Q1 2010


Tempered Water Loop OP1 (Group 3,6, &7) : Once through water on three condensers with a closed tempered water loop LTC (Low temperature Coolant), with an estimated saving of approximately 350 m3 / day. Update : Complete


Q1 2010


Install Cooling Tower For PRODUCT Y Process: Replacement of the once through water to OP3 with a closed recirculation cooling water loop, with an estimated saving of 200 m3/day . Update : Not pursuing Cooling Tower Tie In. Plan in place to pipe Cooling water in Series to 3 pumps. This will reduce the flow rate by 6m3/hr : Complete



Continued Process Optimisation: Survey individual users and jacket set points . Update: Ongoing

M Madigan (Utilities) Continuous

8.5 Reduce the volume of water used on site Raise Site Awareness: Provide regular updates on trends for water usage on site to key stakeholders. Update ; Ongoing


15

No.

Target

Plan

Responsibility

Timescale

8.6 Energy Aspects Review and update EMP In order to continually manage energy onsite effectively, it is vital that all data pertinent to energy flows onsite are gathered and communicated to pertinent stakeholders. Accordingly, the Energy Aspects will be updated at the end of the year and the Energy Management Programme will be updated quarterly. Update: Completed. Energy Aspect 2009 developed in Jan 2010. EMP live document.

M Madigan (Utilities) Q 1 2010

8.7 Reduce Energy usage on site Carry out a CIP of the evaporator heat exchangers to remove fouling on internal surfaces and increase heat exchange efficiency. Update: Complete – Slight improvement in chiller efficiency


8.8 Reduce Energy usage on site Carry out a compressed air site leak detection survey in 2010. Update: Annual Inspection Complete. Slight reduction in compressed air usage.


8.9 Reduce Energy usage on site Replace the porcelain in the thermal oxidizer bed with honeycomb type to reduce gas consumption. Update: Complete : 8% Reduction is gas site usage.


Q3 2010

8.10 Site-wide Energy/ Environmental Awareness Campaign

To reduce energy wastage by improving everyone’s knowledge of energy conservation and their role in reducing energy usage on site, and provide a form for collecting suggestions on energy conservation on site. Update: Week of the 22nd of Feb.

M Madigan (Utilities) & M Slattery

Q1 2010

16

No.

Target

Plan

Responsibility

Timescale

8.11 Reduce energy usage at WWTP Bypassing one of the aeration basins in the WWTP has been identified as having potential for a significant reduction in Energy. Install smaller aeration blower in place of 160Kw units currently in operation Update: Complete, 4%reduction in site electricity usage

M Maguire (EHS) & M Madigan (Utilities)

Q3 2010

8.12 Reduce Energy Usage on Site Carry out feasibility study into the installation of a smaller boiler to service site steam demand more efficiently. Update: An alternative fuel source was identified for the sites steam boiler, under WID an IPPC licence application was prepared and submitted in July to enable co-incineration to be undertaken on site.

T&I Team Q3 2010

8.13 Reduce Energy usage on site Organise brain storming sessions for all departments to identify potential areas where energy could be saved. Update: Brainstorms including utilities usage, competed in January with Depts and Process Teams. All projects assessed for feasibility and if suitable progressed including installation of a wood pellet boiler and solar panels.

T&I Team Q1 2010

17

9.0 Objective

To improve site-wide environmental management in accordance with IPPC Licence, and Corporate requirements

Rationale:

The development and implementation of improved and formalised environmental management systems and procedures will provide a structured framework for co-ordinating site-wide environmental affairs and sustaining Pfizer’s policy of continual improvement. The establishment and maintenance of an Environmental Management System is a specific requirement of the IPC Licence (Condition 2.1) and will be used as a basis for ensuring the fulfilment of Pfizer’s requirements under the Licence.

No.

Target

Plan

Responsibility

Timescale

9.1 Continue to maintain a site wide Environmental Health and Management System

Complete MSR Plan : Complete Management System review Update: Complete 17th May

M Slattery (EHS) Q2 2010

9.2 Maintain the laboratory test method standards

Participate in the Aquacheck proficiency scheme operated by LGC Standards Proficiency Testing at least 4 times in 2010. Update: 5Samples received on site to date in 2010, all results generated were within the accepted tolerances

E Callery (EHS) Q4 2010

9.3 To migrate the paper based legal register to an electronic system

Upgrade form a paper based system to an electronic system. Update : Complete April 2010


18

APPENDIX 3 EMP – Environmental Management Programme Proposals for 2011


ENVIRONMENTAL MANAGEMENT PROGRAMME PROPOSALS 2011 .

1

1.0 INTRODUCTION

The Environmental Management Programme, incorporating the schedule of objectives and targets, is prepared in accordance with the requirements of Condition 2 of Pfizer Ireland Pharmaceuticals, Little Island’s Integrated Pollution Control Licence (Reg. No. 136-04). Cognisance has also been taken of the sections relating to the preparation of EMPs contained in the EPA’s Guidance Note for Annual Environmental Reports.

2.0 ENVIRONMENTAL MANAGEMENT PROGRAMME

This section sets out the Environmental Management Programme for Pfizer Little Island. The programme is broken down into a number of categories as follows: No. Objectives Target dates 1 Process modifications resulting in elimination or

reduction of wastes or the use of alternative less hazardous materials

Q4 2011

2 Improved process control to reduce waste

Q2 2011

3 Maintenance and calibration of key control and monitoring equipment

Q3 2011

4 Use and Improvements in treatment / abatement systems to reduce emissions

Q3 2011

5 Reduction in fugitive emissions

Q4 2011

6 Prevention of incidents with the potential for environmental consequences

Q3 2012

7 Savings in energy, water and material usage

Ongoing

8 General environmental management

Ongoing

For each of these headings, the following information is outlined:

• Objective

• Rationale behind the objective

• Specific targets to achieve the objective

• Plan to achieve the targets

• Timescale

• Persons responsible

ENVIRONMENTAL MANAGEMENT PROGRAMME PROPOSALS 2011 .

2

1.0 Objective

To develop process modifications which will allow for improved yields, the elimination / reduction of wastes and which will allow for the use of alternative less hazardous materials.

Rationale:

Pfizer is committed to improving yields, elimination or reduction of wastes and / or the use of alternative less hazardous materials both at a Corporate and local level. This process is implemented at the earliest stage (by the Technical Services Department) of the process transfer to the plant. Specific requirements relating to the efficiency in use of raw materials and the reduction in waste generated are contained in Pfizer Little Island’s IPPC Licence (Reg. No. 136-03).

No.

Target

Plan/ Update

Responsibility

Timescale

1.1 Review solvent and water usage in the PRODUCT Yes process

Optimisation of PRODUCT Yes process: (1) Investigate the feasibility of reducing the raw material Yes charge by 10% (2kg) (2) Investigate the feasibility of reducing the raw material H used by 10%. (3) Investigate the feasibility of reducing the raw material S wash in CE 306 by 10%.

(1) P Lang (Production) & Leo Ryan (TS)

Q3 2011

1.2 Review solvent and water usage in the PRODUCT X process

Identify and implement potential changes to reduce solvent and water usage in the PRODUCT X process: (1) Investigate the feasibility of reducing the frequency of FD 5701 plate washes, thereby reducing the volume of raw material Z that is used in the process ( 1,000L per batch).

(1) A Fahy, & J Hogan (Production)

Q2 2011

1.3 Review solvent and water usage in the product A & Z process

Identify and implement potential changes to reduce solvent and water usage in the product A&Z process: (1) Investigate the feasibility of reducing the mill clean downs thereby reducing the volumes of raw material Z used and disposed of.

TS (C Brack) Q4 2011

3

No.

Target

Plan/ Update

Responsibility

Timescale

1.4 Replace the current product X,Y & A with the product C & Z process.

Initiate full scale manufacture of product Z with the product C process to deliver a to d below.

a. The process yields significant reductions in hazardous materials. Raw materials, C1 (~170MT/yr), raw material G1(~20MT/Yr) and highly flammable hydrogen gas are not used in the product C&Z process.

b. Butane gas will no longer be emitted from the process which will no longer require special venting and treatment.

c. Elimination of requirement for low temp (<-60ºC) chemistry

d. Reduced solvent and reagent loading (>10%).

PRODUCT C&Z process team

Q3/Q4 2011

1.5 Reduction of off-site transport & treatment of waste

Trial the treatment of 3 aqueous brine waste streams to the WWTP, if successful facilitate continuous treatment of these streams on site from start up of full scale manufacture.


Q3/Q4 2011

1.6 Solvent recovery Implement solvent recovery for raw material O1 and A1 from start up of full scale manufacture


Q3/Q4 2011

4

2.0 Objective

To improve process control (equipment and management) in order to reduce waste.

Rationale:

The introduction of new equipment (e.g. automated control systems and monitoring equipment) and management tools will improve process control at Pfizer Little Island and will contribute to the reduction of waste.

No.

Target

Plan

Responsibility

Timescale

2.1 Reduce the volume of liners and PPE waste sent off site

Complete installation of a solid waste compactor on site, this will maximise the volume of liners and PPE sent out per load and reduce the volume of packaging for same. Compactor installed, commissioning complete, review of waste stream suitability to be completed.


5

3.0 Objective

To maintain and calibrate key control and monitoring equipment.

Rationale:

Specific requirements relating to the maintenance and calibration of key control and monitoring equipment are contained in Pfizer Little Island’s IPC Licence (Reg. No. 136-03).

No.

Target

Plan

Responsibility

Timescale

3.1 Ensure compliance with IPPC licence for discharges from the clarifier for temperature

Install a spiral heat exchanger in the WWTP, this project has been approved at a cost of approx €100,000.

G Mc Namara Q3 2011

3.2 Initiate \ system for using mini-tab tools to track the performance of the WWTP

Implement ppk tools for WWTP parameters to monitor performance, including suspended solids, COD and nutrients.

E Callery Q2 2011

6

4.0 Objective

To improve treatment / abatement systems to reduce emissions.

Rationale:

The evaluation of environmental impacts has identified aqueous emissions as significant for the site. In addition, specific requirements relating to the improvement of treatment / abatement systems are contained in Pfizer Little Island’s IPPC Licence (Reg. No. 136-03)

No.

Target

Plan

Responsibility

Timescale

4.1 Provide weak stream diversion options to Fire Water retention Pond and old weak stream tank

Install two weak stream upset lines from weak stream tank TK-230304 in Bund 517 and one to the Firewater Retention Pond & the Old Weak Stream tank TK-1135. This ensures that if there is a chemical spill onsite of concentrate material that enters the site weak stream drainage system, there are options available to divert this from the WWTP for more appropriate treatment. CPA approved expected start date Feb 2011. €65,000

Projects Engineering (G Mc Namara)

Q 3 2011

7

5.0 Objective

To develop a programme for the reduction of fugitive emissions

Rationale:

Specific requirements relating to the reduction of fugitive emissions are contained in Pfizer Little Island’s IPPC Licence (Reg. No. 136-03).

No.

Target

Plan

Responsibility

Timescale

5.1 Reduce the number of bypass events on the thermal Oxidiser

Continuously monitor and evaluate the root cause of thermal oxidiser bypasses events in an attempt to reduce the number of bypass events.

E Callery (EHS ) Ongoing

5.2

Reduce the number of TO bypasses on the Thermal Oxidiser – By an upgrade of the OP1 vent header system to lean headers.

1. Complete project on scope of the project.

2. Raise and approve CPA. 3. Order equipment & Components 4. Install equipment and components.

E Callery (EHS) & G McNamara (Engineering)

Q2 2012

5.3

Reduce fugitive Emissions from the Product C&Z Process- Minimise fugitive losses by completing on line testing where suitable.

1. Install the raman spectrometer for the PRODUCT C&Z process

2. Qualify and commission the PAT (process analytical technology) currently in use for product C,Z &A for PRODUCT C&Z .

P Mc Gauley (T&I)

Q2 2012

5.4

Reduce fugitive Emissions from the Product C&Z Process- Minimise fugitive losses by eliminating IPTS (In process testing) where not necessary.

Complete a green belt project on the PRODUCT C&Z IPTS to determine the feasibility of eliminating non value added testing.

B Furlong (QC) Q3 2012

8

6.0 Objective

To prevent incidents with the potential for environmental consequences and to prepare and implement contingency plans in the event of an emergency.

Rationale:

Pfizer are committed to maintaining plans and procedures to identify the potential for and respond to incidents and emergency situations and for predicting and mitigating the environmental impacts that may be associated with them. In addition, specific requirements relating to the prevention of incidents with the potential for environmental consequences are contained in Pfizer Little Island IPPC Reg. No. 136-03).

No.

Target

Plan

Responsibility

Timescale

6.1 Ensure site is prepared in the event of an emergency

Maintain Emergency Management Team and Emergency Response Team training schedule

EHS (D O'Herlihy) Continuous

6.2 To develop a programme for testing the integrity and water tightness of all bunding structures on site

Continue programme for testing integrity and water tightness of all bunding structures on site.

EHS (M.Slattery) Continuous

6.3 Ensure adequate containment in the event of leakage or spillage

Construct a dedicated storage area for acetic acid, caustic and nickel drums cost approved approx €75,000

Engineering (G Mc Namara)

Q2 2011

6.4 Test the integrity of the fire water retention pond

Complete repairs and carry out spark testing. Work 80% complete, expected completion due to unsuitable weather conditions (Frost & rain) this work has to be moved out to Q1 2011


Q1 2011

9

7.0 Objective

To identify savings in energy, water and material usage.

Rationale:

The evaluation of environmental impacts has identified energy and water use as significant for the site. In addition, specific requirements relating to the identification of savings in energy and material usage are contained in Pfizer Little Island’s IPPC Licence (Reg. No. 136-03).

No.

Target

Plan

Responsibility

Timescale


Complete a feasibility study on the installation of chilled water loop in OP1 in place of the current low temp distribution system

M Madigan Q1 2011

7.2 Reduce Air Usage Investigate the installation of a VSD on the fixed speed compressors currently in operation

M Madigan Q2 2011

7.3 Reduce Energy Usage Reduce airflow FD-5701 M Madigan Q2 2011 7.4 Reduce electricity Usage on site Install smart cool controllers on Site Chillers M Madigan Q2 2011 7.5 Reduce energy usage on site Insulate cavity wall of external wall of

Admin. Building M Madigan Q1 2011


Continued Process Optimisation: Survey individual users and jacket set points .


7.7 Reduce the volume of water used on site Raise Site Awareness: Provide regular updates on trends for water usage on site to key stakeholders.


10

No.

Target

Plan

Responsibility

Timescale

7.8 Energy Aspects Review and update EMP In order to continually manage energy onsite effectively, it is vital that all data pertinent to energy flows onsite are gathered and communicated to pertinent stakeholders. Accordingly, the Energy Aspects will be updated at the end of the year and the Energy Management Programme will be updated quarterly.


7.9 Reduce Energy usage on site Carry out a compressed air site leak detection survey in 2011.


7.10 Site-wide Energy/ Environmental Awareness Campaign

To reduce energy wastage by improving everyone’s knowledge of energy conservation and their role in reducing energy usage on site, and provide a form for collecting suggestions on energy conservation, waste & water reduction site.

M Slattery (EHS) & M Madigan (Utilities)

Q2 2011

7.11 Reduce Energy Usage on Site Following the IPPC licence review for use of distillates as a fuel in the boiler,

1) Complete the boiler test burn 2) Complete configuration to enable

distillates from product X,Y &A to be used

3) Complete configuration & set up to enable Product C&Z distillates to be used.

T&I Team, EHS, Engineering

1) Q2 2011 2) Q3 2011

3) Q4 2011

11

8.0 Objective

To improve site-wide environmental management in accordance with IPPC Licence, and Corporate requirements

Rationale:

The development and implementation of improved and formalised environmental management systems and procedures will provide a structured framework for co-ordinating site-wide environmental affairs and sustaining Pfizer’s policy of continual improvement. The establishment and maintenance of an Environmental Management System is a specific requirement of the IPC Licence (Condition 2.1) and will be used as a basis for ensuring the fulfilment of Pfizer’s requirements under the Licence.

No.

Target

Plan

Responsibility

Timescale

8.1 Continue to maintain a site wide Environmental Health and Management System

Complete MSR Plan : Complete Management System review


8.2 Maintain the laboratory test method standards

Participate in the Aquacheck proficiency scheme operated by LGC Standards.


8.3 Optimise laboratory Standards Update the current laboratory management system to comply with ISO 17025.


12

APPENDIX 4 EMP – Bund Integrity 2010


Bund Test Data 2010 Bund

Number Bund Description Bund Location Year Last

Tested Month Tested Status in 2010

103 Solvent Tanks(TK201,202,203) Tank Farm (Central Aspect) 2007 Aug Passed

104 TBIN Tanks (TK207/208) Tank Farm (Central Aspect) 2007 Aug Passed

105 HCl Tank(TK204) Tank Farm (Central Aspect) 2007 Aug Passed

107 Ni Ion Exchange pre treatment Area South of Tank Farm 2007 June Passed

110 Pump Bund (TBIN)(PU247,248,243,242,241)

Tank Farm (Southern side) 2007 Aug Passed

115a Pump Bund Adjacent to 115 Tank Farm (Western side) New bund July Passed

116 Pyrophorics Storage Area NW Aspect of Tank Farm 2007 July Passed

117 Northside Foam Tank Bund Northern Aspect of Tank Farm 2007 July Passed

118 Ator M/L Distillation Unit South of Tank Farm 2007 Aug Passed

119 Pump Bund East of Tank Farm 2007 July Passed

122 Liquid/liquid Extraction Column Tank Farm (Southwest side) 2007 July Passed

123 ATC Skid Plastic Bund ATC Skid 2007 Aug Passed

124 ATC Skid Plastic Bund ATC Skid 2007 Aug Passed

301 Tk904/ DR201 SE Aspect of OP1 2007 Aug Passed

309 SC 401 NE Aspect of OP1 2007 Aug Passed

313 Vacuum Pump VP681201 Transvac Room S Aspect of OP1 2007 Sept Failed Initial test bund was repaired

and re-tested.

413 Northside Pumphouse (Diesel Tank) Northern Perimeter of Site 2007 Sept Passed

426 Diesel Generator Equipment In New Utilities Building 2007 Oct Failed Initial test bund was repaired

and re-tested.

427 Paint Storage Cabinet South west of maintenance Building 2007 Aug Passed

428 Tanker Lay Down Area Northern Perimeter of Site 2007 Oct

Failed Initial test bund was repaired

and re-tested.

501 WWTP Pumps / Aeration System In New Utilities Building 2007 Sept Failed Initial test bund was repaired

and re-tested.

504 Temporary Drum Storage Area Southern Aspect of WWTP 2007 Sept Passed

505 New waste drum store plinth Eastern Aspect of WWTP 2007 Sept Failed Initial test bund was repaired

and re-tested.

506 Truck Loading Station North Eastern Aspect of WWTP 2007 Aug Passed

507 Sulphuric Acid Dosing North Eastern Aspect of WWTP 2007 June Passed

508 Sulphuric Acid Dosing North Eastern Aspect of WWTP 2007 June Passed

509 NaOH Dosing North Eastern Aspect of WWTP 2007 June Passed

510 NaOH Dosing North Eastern Aspect of WWTP 2007 June Passed

511 Urea Dosing North Eastern Aspect of WWTP 2007 June Passed

512 Polymer Dosing North Eastern Aspect of WWTP 2007 June Passed

521 Caustic Storage Area West of Grp 5 Installed - 2010

May Passed

522 Nickel ASP Storage Area

West of Grp 5 Installed - 2010 May Passed

523 Waste Oil Storage In maintenance yard Installed - 2010

May Passed

524 Laboratory Waste Staging Area East Entrance to warehouse Installed - 2010

May Passed

PB 007

Portable Bund DIW 2007 Oct Passed

PB 008

Portable Bund DIW 2007 Oct Passed

B124 Portable Bunds

ATC Skid 2007 Aug Passed

B123 Portable Bunds

ATC Skid 2007 Aug Passed

APPENDIX 5 PRTR 2010


APPENDIX 6 Review of Decomissioning Management Plan


Pfizer Ireland Pharmaceuticals\46402006 Pfizer Anninfo RMP ELRA 2010\DURP0001/JAG/JAG

DMP Update 2011

Decommissioning Management Plan

31 March 2011 Final

Issue No 1 46402007 /

DMP Update 2011


Pfizer Ireland Pharmaceuticals\46402006 Pfizer Anninfo RMP ELRA 2010\DURP0001/JAG/JAG 31 March 2011

Final

Project Title: DMP Update 2011

Report Title: Decommissioning Management Plan


Report Ref:

Status: Final


Client Company Name: Pfizer Ireland Pharmaceuticals

Issued By: URS Ireland Iveagh Court 6-8 Harcourt Road Dublin 2 Ireland Tel: +353 (0) 1 415 5100 Fax: +353 (0) 1 415 5101


Name Signature Date Position

Prepared by

John Grumley

31-03-2011 Project Manager

Checked & Approved by

Peter Hassett

31-03-2011 Director, URS Ireland Ltd

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CONTENTS

Section Page No

1. INTRODUCTION .............................................................................................................. 1

1.1 Requirement for a Decommissioning Management Plan (DMP) ..................................... 1 1.2 Key Changes since previous RMP update ...................................................................... 2 1.3 Basis for the DMP ............................................................................................................ 3 1.4 Site Close-Down Scenario: Comments and Assumptions ............................................... 3 1.5 DMP Report Structure ...................................................................................................... 4

2. PIP SITE LOCATION AND HISTORY ............................................................................. 6

2.1 Site Location ..................................................................................................................... 6 2.2 History of PIP ................................................................................................................... 6 2.3 Site and Process Description ........................................................................................... 8

3. SCREENING AND OPERATIONAL RISK ASSESSMENT .......................................... 11

3.1 General ........................................................................................................................... 11 3.2 Complexity ...................................................................................................................... 11

4. SCOPE OF DMP ............................................................................................................ 13

4.1 General ........................................................................................................................... 13 4.2 Exclusions From the DMP .............................................................................................. 14

5. CRITERIA FOR SUCCESSFUL DECOMMISSIONING ................................................ 14

6. MANAGEMENT OF THE DMP ...................................................................................... 16

7. PROGRAM TO ACHIEVE STATED CRITERIA ............................................................ 17

7.1 Closure Plan ................................................................................................................... 17 7.2 Restoration and Aftercare Management Plan – Management of Potential Long

Term Residual Soil and Groundwater Contamination.................................................... 36 7.3 DMP Completion Timeframe .......................................................................................... 39 7.4 DMP Test Programme ................................................................................................... 40 7.5 Final Validation ............................................................................................................... 40

8. SUMMARY OF COSTS ASSOCIATED WITH THE DMP ............................................. 42

9. UNDERWRITING THE DMP – FINANCIAL PROVISIONS........................................... 42

10. REVIEW OF THE DMP .................................................................................................. 44

11. LIMITATIONS ................................................................................................................ 45

12. COPYRIGHT .................................................................................................................. 45

APPENDIX A - SITE LOCATIONS AND LAYOUTS

APPENDIX B - GANTT CHART

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CONTENTS

Section Page No

APPENDIX C - FINANCIAL PROVISION LICENCE REGISTER NO P0136-04

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1. INTRODUCTION

1.1 Requirement for a Decommissioning Management Plan (DMP)

The Pfizer Ireland Pharmaceuticals (PIP) facility, situated in Wallingstown, Little Island, County Cork, Ireland, is a manufacturer conducting chemical synthesis of bulk active ingredients for use in pharmaceutical manufacturing.

PIP was granted an Integrated Pollution Control Licence (Register Number P0136-01 by the Environmental Protection Agency (EPA) on the 20 December 1996 for the manufacture of pesticides, pharmaceutical or veterinary products and their intermediates. This licence was reviewed three times and the current Integrated Pollution Prevention and Control Licence (IPPC) (Reg. No. P0136-04) which was issued by the Environmental Protection Agency (EPA) on the 7 January 2011 for:

‘The use of a chemical or biological process for the production of basic pharmaceutical products’; and

‘The recovery of waste in a facility, within the meaning of the Act of 1996, which facility is connected or associated with another activity specified in this Schedule in respect of which a licence or revised licence under Part IV is in force or in respect of which a licence under the said Part is or will be required.’

Environmental management of the site is regulated by the conditions outlined in PIP’s Integrated Pollution Prevention and Control Licence Reg. No. P0136-04.

Condition 10 of the IPPC license requires the preparation and submittal to the EPA of a Decommissioning Management Plan (DMP). The specific requirements are as follows;

Condition 10: Decommissioning & Residuals Management/Closure, Restoration and Aftercare Management

10.1 Following termination, or planned cessation for a period greater than six months, of use or involvement of all or part of the site in the licensed activity, the licensee shall, to the satisfaction of the Agency, decommission, render safe or remove for disposal/recovery, any soil, subsoils, buildings, plant or equipment, or any waste, materials or substances or other matter contained therein or thereon, that may result in environmental pollution.

10.2 Decommissioning Management Plan (DMP)/Closure, Restoration and Aftercare Management (CRAMP)

10.2.1 The licensee shall prepare, to the satisfaction of the Agency, a fully detailed and costed plan for the decommissioning or closure of the site or part thereof.

10.2.2 The plan shall be reviewed annually and proposed amendments thereto notified to the Agency for agreement as part of the AER. No amendments may be implemented without the agreement of the Agency.

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10.2.3 The licensee shall have regard to the Environmental Protection Agency Guidance on Environmental Liability Risk Assessment, Decommissioning Management Plans and Financial Provision when implementing Condition 10.2.1 above.

10.3 The Decommissioning Management Plan/CRAMP shall include as a minimum, the following:-

i. A scope statement for the plan.

ii. The criteria which define the successful decommissioning of the activity or part thereof, which ensures minimum impact on the environment.

iii. A program to achieve the stated criteria.

iv. Where relevant, a test program to demonstrate the successful implementation of the decommissioning plan.

v. Details of the costings for the plan and the financial provisions to underwrite those costs.

10.4 A final validation report to include a certificate of completion for the residuals 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.

Reason: To make provision for the proper closure of the activity ensuring protection of the environment

The EPA Guidance Document entitled “Guidance on Environmental Liability Risk Assessment, Residuals Management Plans and Financial Provisions” (hereafter referred to the EPA Guidance Document) was used in the preparation of this Decommissioning Management Plan.

The original RMP was prepared in March 2008 and subsequently updated in March 2009 and again in March 2010.

This report presents the 2011 annual review of the original RMP, as required in Condition 10.2.2 of the site’s IPPC license.

1.2 Key Changes since previous RMP update

A revised Integrated Pollution Prevention and Control Licence (IPPC) (Reg. No. P0136-04) was issued by the Environmental Protection Agency (EPA) on the 7 January 2011 to account for the upgrade of Boiler A to burn organic distillate as a fuel: To use organic distillate as an alternative fuel in Boiler A, the following site modifications have been incorporated into the design of the co-incinerator: Organic Distillates is collected from production on a per batch basis in a holding tank for use as a fuel in Boiler A. A new feed

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system to transport organic distillate to the boiler has been incorporated into the boiler skid. (2011). P0136-04 was updated to include the following associated activity:


The sites IPPC license was transferred from ‘Pfizer Overseas Pharmaceuticals (having changed its name to Pfizer Ireland Pharmaceuticals) and C.P. Pharmaceuticals International C.V. (a limited partnership represented by and acting through Pfizer Manufacturing LLC and Pfizer Production LLC) trading as Pfizer Ireland Pharmaceuticals’ to Pfizer (NEW PIP) Holdings [Registered Number 490938].

Condition 10 of P0136-04 changed from Decommissioning and Residuals Management to Decommissioning & Residuals Management/Closure, Restoration and Aftercare Management. This has resulted in the RMP being renamed the DMP.

1.3 Basis for the DMP

The basis of this DMP is as follows:

• A review of the activities carried out at the site and activities licensed, including process and services;

• Identification of existing and potential hazards, including evaluation of materials and wastes generated;

• Consideration of historic environmental incidents and remediation works undertaken;

• Identification of all items of plant and other materials that may be decommissioned, rendered safe or removed from the site for disposal or recovery in the event of closure; and

• Identification of locations where cleaning, decontamination or remediation works may be required in the event of decommissioning to prevent environmental pollution.

1.4 Site Close-Down Scenario: Comments and Assumptions

In order to develop a fully costed DMP for the PIP site, a number of assumptions have been made with regard to the mode and management of a hypothetical site shut down.

The company operates a strict environmental policy. Therefore, any shutdown of the site will be a well-planned and well resourced event. This implies that the shut-down date will be known well in advance and that both production schedules and raw materials purchasing have been planned with the shut-down already factored in. It also implies that PIP will have the resources in terms of both financial inputs and manpower to implement

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the DMP through completion – with no requirement for external financing or manpower other than for expert advice.

A general assumption is that completion of the plan will result in a decommissioned and decontaminated site suitable for future industrial use, unless the site can be sold as a going concern to a third party, the nature of which will not trigger the decommissioning mechanism. All buildings and some site services, whilst emptied and cleaned as part of the DMP, will be assumed to remain in place following vacation of the site by PIP. Certain site areas will continue to operate or remain operational after site decommissioning. These include facilities such as the fire protection system, diesel supply to the back-up generator for the fire protection system.

The second general assumption is that all parts of the site are closed as part of one comprehensive DMP. No direct reference to partial closure is made in the DMP. The DMP and associated costs have been developed for a number of discrete program stages arranged in a logical sequence to facilitate complete site closure. The actual steps to be carried out and their associated costs for any partial shut downs may be derived from the DMP by simply reviewing that part of the DMP which covers that specific activity or land-parcel.

The third general assumption is that the DMP will be reviewed and updated as necessary, on an annual basis as part of the AER. The annual review of the DMP will take any changes in site status into consideration and incorporate current planned activities.

1.5 DMP Report Structure

The structure of the DMP is outlined as follows:

Section 1 provides introduction and background to the DMP.

Section 2 provides an evaluation and overview of the main site and surrounding history and describes items such as buildings, activities and issues on the existing sites, which are covered in the plan.

Section 3 describes the initial screening and operational risk assessment carried out for the PIP facility.

Section 4 outlines the scope of the DMP, the type of closure envisaged and any exclusions in the DMP.

Section 5 describes the proposed criteria to be used to demonstrate successful decommissioning and decontamination.

Section 6 outlines management responsibilities for the implementation of the plan.

Section 7 describes the DMP in a Project Management style with discrete stages and associated tasks. Two programs are considered:

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1. Closure Plan (CP) - the decommissioning and decontamination of all above and below ground structures – including management of residues arising at the main site.

2. Restoration and Aftercare Management Plan (RAMP) – the management of any potential long-term residual soil and ground water contamination at the main site and at the off-site landfill.

Sections 8 provide a summary of the costs associated with implementation of the DMP, the provisions in place at PIP to underwrite the costs associated with the DMP and the need to review and update the DMP.

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2. PIP SITE LOCATION AND HISTORY

2.1 Site Location

The facility is located on Little Island in Cork, Ireland, on an industrial estate shared by a number of pharmaceutical/chemical companies and various other production facilities. A site location map is shown in Figure 1. In the area surrounding the facility, the land is used as follows:

East: Showerlux, a producer of shower fixtures. Further to the east is a major development of office and light industrial facilities (Eastgate Business Park);

South: Little Island’s main road and Cara Partners, a producer of a homeopathic medicine;

West: Ellis and Bury’s Bridge Basin (surface water bodies) and Pfizer Cork Limited, a pharmaceutical company that ceased operations in 2010;

North: N25 dual carriageway.

Other nearby industrial facilities include; Janssen, Irotec and FMC - pharmaceutical companies; and, BASF, a detergent manufacturer, Henkel, manufacturers of mining ore extraction liquors and the former Mitsui Denman site, formerly a producer of manganese dioxide for batteries.

Most of the surrounding land on the island is zoned for industrial use. The island is also shared by a small number of residential properties. Within one kilometre of the facility there is a population of approximately 500 people. There is a school approximately one kilometre to the east of the facility. There is one designated Special Area of Conservation, (Great Island Channel) and one Special Protection Area (Cork harbour) located >1km south of the site. There is a small area of woodland located approximately 1.5 km to the north west of the site, and which is situated within the IPPC boundary of the Pfizer Cork Limited facility, which is classified as a proposed natural heritage area by the Cork Planning Authority owing to its value to nesting birds. There are no major tracts of agricultural land in close proximity to the site.

2.2 History of PIP

The manufacture of fine chemicals and pharmaceutical actives commenced on the site in 1978 with the commissioning of the Plaistow plant. The plant was bought by Warner Lambert in 1997 and, following the acquisition of Warner Lambert (WL) by Pfizer Incorporated in 2000, is now owned by PIP. Prior to 1978, it is understood that the site had been used for agricultural purposes.

There have been a number of site modifications since the commencement of site operations. Those modifications which are of environmental significance include:

• Site waste water treatment: new plant (1988); sludge dewatering (1994); additional oxygen input (1996); weak stream equalisation (1997); separation of

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weak/strong stream (1997); installation of new strong stream tank (1997/98); improved clarification (1998); new plant including balancing tanks, activated sludge tanks, clarifier, sludge holding tank and sludge dewatering facility (2000), strong stream process lines upgraded to an above ground system (2007).

• Firewater retention facility: re-routing of surface water drains and construction of a firewater retention pond (1996/97), and implementation of automatic pen-stock valve at firewater pond outlet controlled by continuous Total Organic Carbon (TOC) and pH monitors (1999); new surface water monitoring system prior installed which by-passes firewater retention pond and discharges directly to waters unless TOC or pH levels are exceeded (2000).

• Drum storage: construction of a paved drum storage area with secondary containment in 1992, new paved area adjacent to tank farm (1996); construction of a new drum storage building (2000).

• New production facilities: extension of production building and hydrogenation building in 1996; construction of a dryer building (2000); Durr Thermal Oxidiser (2001).

• Drain rehabilitation: programme of inspection and repair completed (1997 – 2007). Sump D repair (2003)

• Upgrade of pilot plant building: refurbishment for small scale production (2002);

• Upgrade of Tank Farm for Raw Materials and Waste Solvents: A new loading/unloading system for tankers delivering raw material and collecting waste solvent was installed (2004).

• Construction of new engineering stores: A new engineering stores was constructed. The old engineering warehouse was demolished as part of this development (2005).In 2010, the Technical Services Administration area was converted to a laboratory for the trial production of high containment products with the installation of new air handling unit, fume hoods, vessels, small reactors and receivers.

• 4 new bunds were installed in 2010, comprising:

o Caustic Storage Tank (TK521);

o Nickel ASP Storage tank (TK522);

o Waste oil Storage (TK523); and

o Laboratory waste Storage Area (TK524).

• In 2010, new portacabins were installed on the east side of the old WWTP building.

• New environmental protection measures implemented during 2010, comprise:

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o New HCl tank installed & upgrading of the HCl bund.

o Upgrading of WWTP Bunds; and

o WWTP black belt completed.

• Upgrade of Boiler ‘A’ to burn organic distillate as a fuel: In order to reduce the consumption of indigenous fuel (natural gas), reduced carbon dioxide emissions and save costs, a project is ongoing to re-use clean organic distillates generated from production as a fuel for Boiler ‘A’. This project was the main reason for a revised IPPC licence application for the site, the revised licence (P0136-04) having been issued in January 2011. Licence P0136-04 now allows the co-incineration of these distillates with natural gas in Boiler ‘A’, subject to a range of new conditions in licence P0136-04. In order to facilitate co-incineration, modifications have been incorporated into the design of the boiler. organic distillates is collected from production on a per batch basis in a holding tank for use as a fuel in Boiler A. A new feed system to transport organic distillate to the boiler has been incorporated into the boiler skid.

• In 2010, small quantities of new products were manufactured on-site. However, this has not resulted in any substantial changes to the product profile on site. The new products comprised:

o Product S;

o Product S Crude; and

o Product T.

2.3 Site and Process Description

PIP, Wallingstown, produce bulk pharmaceutical intermediate active products in batch processes. Any one product is manufactured in well planned ‘campaigns’ (i.e., a predetermined number of batches with target yields).

• Principle raw materials used in production are:

o Intermediates from other production facilities;

o Organic and inorganic reactants;

o Organic solvents (not generally taking place in the chemical reactions); and

o Catalysts.

The raw materials used are generally solid and liquid with gaseous raw materials required for some products (e.g., hydrogen and ammonia).

Key equipment used includes:

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• Solvent manifold systems and solids charging booths;

• Reactor vessels of varying volumetric capacity;

• Separation equipment comprising mainly centrifuges and filters;

• Driers; and

• Milling equipment.

PIP employs approximately 180 staff and 60 to 70 contractors on-site, primarily in a four-shift operation. The facility operates 24 hour per day, 7 days per week, 49 weeks per year.

The current site is comprised of approximately 4.8 hectares of useable land. Current production facilities occupy approximately 8,600 m2 of the site comprising:

• two-story building, housing laboratories and administration;

• multi-story pilot plant building;

• single-story warehouse building;

• two-story production building;

• two-story utilities services building;

• main fresh solvent drum and waste storage area;

• tank farm for raw materials and waste solvents;

• an outdoors drum store, on hard standing with secondary containment;

• wastewater treatment plant;

• multi-story dryer building;

• a drum storage building;

• a fresh solvent drum plinth;

• three thermal oxidisers;

• centrifuge building; and

• security building.

The following utilities are listed and are mainly located in the utilities building:

• Steam generation;

• Electricity from the ESB;

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• Mains water from Cork County Council;

• De-ionised water generation;

• Compressed air generation;

• Nitrogen;

• Chilling systems;

• Natural gas Boiler;

• Co-incinerator; and

• Emergency diesel generator with an associated diesel tank (5000 litres).

The pilot plant building at the facility is used for the trial production of high containment products.

PIP received a Technical Amendment A to the current licence on the 15th October 2008. Technical Amendment A allows for the generation of chlorine as a by-product in a new process commenced during 2009. Chlorine emissions are treated by a scrubber and released into the atmosphere through the Adtech Thermal Oxidiser stack (air emission point V6). However, the emissions from this process are not treated in the Adtech Thermal Oxidiser.

PIP received a revised licence on the 7th January 2011. The revised licence permits the to use distillates (solvents) arising as residues from the site production processes as fuel in the sites steam raising boiler.

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3. SCREENING AND OPERATIONAL RISK ASSESSMENT

3.1 General

As a starting point in the process, a relatively simple risk assessment decision matrix can be used to classify sites according to Low, Medium and High risk and thereby select the specific DMP and Financial Provision (FP) requirements that will be needed. The risk assessment decision matrix outlined in the EPA Guidance Document was used.

The risk assigned to the facility depends on the complexity of operations at the site, the environmental sensitivity of the receiving environment and the compliance record (compliance history) of the facility.

• Complexity – the extent and magnitude of potential hazards present due to the operation of the facility (e.g. a function of the nature of the activity, the volumes of hazardous materials stored on site etc.). A Complexity Band (G1 least complex to G5 most complex) for each class of activity has been assigned and included in a Look-Up Table (Appendix B of the EPA Guidance Document).

• Environmental Sensitivity – the sensitivity of the receiving environment in the vicinity of the facility, with more sensitive locations given a higher score (e.g. the presence of aquifers below the site, groundwater vulnerability, the proximity to surface water bodies and their status, the proximity to sensitive human receptors, etc). The Environmental Sensitivity is calculated on a site-specific basis using a sub-matrix (Table 3.1).

• Compliance Record – the compliance history of the facility.

Each aspect is multiplied to give the Total Score for the facility, and this can be used to place the facility into an appropriate Risk Category as follows:

• Risk Category 1 = Score < 5

• Risk Category 2 = Score 5 - 23

• Risk Category 3 = Score = > 23.

Once this has been completed, the licensee proceeds through the relevant steps of DMP and financial provisions that are considered appropriate for the Risk Category.

3.2 Complexity

A look up table for Irish activities has been included in Appendix A of the EPA’s Guidance Document.

The Complexity Band is used to determine the value used in the Operational Risk Assessments as follows:

G1 = 1, G2 = 2, G3 = 3, G4 = 4 and G5 = 5

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In January 2011, PIP were granted a revised IPPC License Registration No. P0136-04. PIPs main activity is classed under section 5.16 and its associated activity is classed under section 11.1. The relevant complexity band for PIP according to the EPA Guidance Document is detailed in the table as follows:

Table 3.1 IPPC Activities and Complexity Bands IPPC Category

Activity Relevant PIP Complexity Band

5.16 the use of a chemical or biological process for the production of basic pharmaceutical products

PIP uses <2000 tonnes per annum and therefore it is assigned Complexity Band G3

11.1 The recovery of waste in a facility, within the meaning of the Act of 1996, which facility is connected or associated with another activity specified in this Schedule in respect of which a licence or revised licence under Part IV is in force or in respect of which a licence under the said Part is or will be required.

In 2011, PIP plan to use a co-incinerator to incinerator organic distillates and therefore it is assigned Complexity Band G5

The highest complexity band assigned to PIP is G5, in accordance with the EPA guidance document a site with a complexity band of G5 is automatically assigned a risk category of 3. This infers that the overall risk of the PIP facility is high. As stated in the EPA Guidance Document, for Category 3 facilities, clean closure may not be achievable due to either the nature of the operation or due to residual contaminated land issues. Therefore a process of extensive restoration and aftercare may be required. In the case of PIP there is known groundwater contamination and therefore a Closure, Restoration and Aftercare Management Plan (CRAMP) is provided for in Section 7.

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4. SCOPE OF DMP

4.1 General

The proposed DMP addresses both short/medium-term (Closure Plan) actions and a longer-term programme (Restoration and Aftercare Management Plan). Together, these form the Closure, Restoration and Aftercare Management Plan (CRAMP) for the site.

The Closure Plan (refer to Section 7.1) will involve decommissioning and decontamination of all process related structures currently used for production activities.

This will involve decommissioning and decontamination of:

• All production buildings;

• All service areas;

• All storage areas; and

• All residuals arising as a direct result of decommissioning.

Site operations generate hazardous and non-hazardous waste. The types of waste generated are outlined in Section 7 of this report. The amount of waste generated will increase significantly during implementation of the DMP with the following being of particular significance:

• Hazardous materials such as obsolete raw materials, chemicals, hazardous liquid wastes from cleaning operations, etc.

• Non hazardous wastes.

Additional hazardous wastes that may arise during decommissioning are as follows:

• Ductwork contaminated with API’s; and

• Equipment contaminated with API’s.

Any waste arising during decommissioning will be managed in accordance with Condition 8 of IPPC License Reg. No P0136-04.

The Restoration and Aftercare Management Plan (presented in Section 7.2) will address any medium to long-term issues associated with residual soil and groundwater contamination that may have resulted from the PIP history of activities across the lands owned by the company. A programme of post closure intrusive investigation is outlined in Section 7.2.3 should a post closure plan be needed at the time of closure.

Figure 2 (see Appendix A) is a site plan of main site owed by PIP. This site plan identifies the main process areas.

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4.2 Exclusions From the DMP

The following items are excluded from the scope of this DMP:

• Costs for building demolition and uncontaminated equipment removal.

• The costs of removing above and below ground structures.

The only exception is where buildings and/or structures have to be removed to either assess residual soil and groundwater (S&GW) contamination or for the implementation of the S&GW remediation program – see Section 7.2.

5. CRITERIA FOR SUCCESSFUL DECOMMISSIONING

The criteria for successful decommissioning to ensure minimum impact on the environment with respect to residuals management are as follows:

1. Decontamination of all process equipment.

2. Documented and fully costed reports to ensure that all raw materials and finished product have been dispatched from the site.

3. Documented and fully costed reports on the disposal of hazardous waste including full certification required under law (Trans-frontier Shipment of Hazardous Waste Regulations, 1998, Waste Management Act, 1996 and any amendments to waste legislation, and the company’s IPPC Licence).

4. Documented and fully costed reports on the disposal of non hazardous wastes including all certification required under the Waste Management Act and IPPC licence.

5. Documentation relating to the proper management, and if necessary removal, of asbestos containing materials.

6. Documentation relating to the proper management, and if necessary removal, of PCBs/PCTs.

7. Removal of radioactive sources (if present) and disposal by contractors licensed by the Radiological Protection Board.

8. Remediation of site soil and groundwater to pre-determined, risk based, remedial goals, agreed with the EPA and verified by a program of groundwater monitoring post corrective action.

9. A final validation report including a certificate of completion for the residuals management plan, for all or part of the site as necessary, which will be submitted to the Agency within three months of execution of the plan.

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10. The costs and time to complete decommissioning should not exceed that estimated in the most up-to-date revision of the DMP in place at the time of decommissioning.

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6. MANAGEMENT OF THE DMP

The overall responsibility and management of the DMP will be undertaken by designated members of site management, other relevant company personnel etc. Responsibilities of this technical team will be formally defined. Prior to commencement of the DMP, this team will be established.

The selection of personnel to form this team will adequately address the important aspects of the DMP including financial management, environmental management etc. All decontamination procedures, decommissioning operations and residuals management, as required under this DMP will be authorised by the team.

In addition, the team will nominate a company co-ordinator to conduct all necessary communications with relevant authorities and ensure the appropriate information transfer.

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7. PROGRAM TO ACHIEVE STATED CRITERIA

7.1 Closure Plan

7.1.1 General

The Closure Plan involves the decommissioning and decontamination of all above and below ground structures, including management of residues arising.

The structure of the Closure Plan included in this DMP is based on a logical sequence of events (project milestones) that would occur in the event of a shutdown, similar in logic to an annual maintenance shutdown. However, the end point would be the removal of all materials from the site that could pose a residual threat to the environment. All remaining structures/buildings would be in a steady-state and safe condition.

Below ground structures, in-ground sumps, drains and transfer lines, are dealt with in the Closure Plan only in relation to decontamination of internal surface areas i.e. emptying and flush/rinse etc. Issues associated with removal of structures that may be required for assessment of soil/groundwater contamination are dealt with in Restoration and Aftercare Management Plan.

The Closure Plan is constructed in a Project Management style format with a number of stages, each with a set of specific tasks that involve the management of residual waste. The individual stages are in a logical sequence however; some overlap in terms of time-lines is expected.

The individual stages are:

Stage 1: Production decommissioning, including transfer of residuals to on-site storage;

Stage 2: Removal of excess raw materials and final product from site;

Stage 3: Removal of production related hazardous/non-hazardous wastes from site;

Stage 4: Contract cleaning of tanks, bunds, sumps and interceptors;

Stage 5: Removal of non-process related materials and non-hazardous wastes;

Stage 6: Decommissioning of site services;

Stage 7: Decommissioning of the Equalisation Tanks and Wastewater Treatment Plant;

Stage 8: Removal of residual hazardous materials (non process related); and,

Stage 9: Documentation and certification of decommissioning and decontamination.

Each stage is considered under the following headings:

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• Tasks to complete stage;

• Cost to complete;

• Time to complete; and,

• Plant status at completion of stage.

Please refer to Appendix B (Gantt chart with stages/tasks and timelines).

7.1.2 Stage 1: Production Decommissioning

This stage will be applied to:

• Production buildings 1, 2 and 3 which house the 10 reactor groups;

• Dryer building;

• Centrifuge building;

• High Containment Pilot plant; and

• Laboratories.

With regard to programs for production decontamination, it is considered that many such programs are currently in place due to the strict cleaning regimes and regulatory and legislative requirements in force. These programs can be utilised or adapted for use as part of DMP implementation.

Furthermore, site utilities required for decontamination and decommissioning procedures are considered to be readily available on-site for utilisation during implementation of the DMP.

In the event of a plant shut down, it is assumed that all raw materials are processed through the individual production areas.

The production areas are now considered in more detail with particulars taken from site documentation on standard operating procedures for equipment cleaning operations and corporate procedures on decommissioning.

Stage 1 - Task 1: Cancellation of incoming materials

As stated previously, it is assumed that any shutdown of the site will be a well-planned event. This implies that the shut-down date will be known well in advance and that both process schedules and inputs of raw materials have been planned with the shut-down already factored in.

All contracts relating to the delivery of supplies and materials will be cancelled. All contracts other than those that are concerned with the DMP or related to safety of personnel or the environment will be terminated.

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Stage 1 - Task 2: Transfer all raw materials and finished product to warehouse and drum storage

It is assumed that all raw materials are processed through the individual production areas of the facility, with any remaining quantities retained in designated storage.

Assume reaction and filtration steps are completed. Therefore, allow for discharge of product from filtration centrifuging, drying and discharging to product containers. Then, in respect of residuals in Production Buildings 1, 2 and 3, Dryer Building, Pilot Plant and laboratories:

• Label product drums and transfer to the warehouse.

• Isolate solvent manifolds, drain solvent back to bulk solvent storage, and purge manifolds.

• Remove drums of solvent to drum storage.

• Transfer any containers of raw materials to the warehouse.

• Remove hydrogenation bottles from hydrogenation area and purge manifold. Place bottles of hydrogen in hydrogen storage area.

• Create an inventory of obsolete liquid chemicals in the laboratory and transfer to waste storage in accordance with appropriate standard operating procedure (SOP).

Stage 1 - Task 3: Transfer all production solid wastes, hazardous and non hazardous, to drum storage or other suitable storage facility

This task will include the specific transfer of hazardous and non-hazardous solid waste to appropriate storage on-site, as follows:

• Transfer of solid hazardous waste bags, properly sealed according to appropriate standard operating procedures (SOP’s), to UN approved and labelled 120 litre drums in the solid waste storage area. Solid waste is stored in the waste drum plinth located on the north easterly side of the site.

• Similar transfer of hazardous solid waste in doubly contained drums from the Pilot Plant to on-site storage.

• Transfer of drums, primarily fibre kegs and plastic drums, from production buildings and the Pilot Plant to solid waste storage area.

• Transfer of pallets to solid waste storage area.

• Filtration of specialist catalysts (about 300 kg used in one reactor) in a sparkler filter, recovery of filtered catalyst into special drums and transfer of drums to the catalyst storage compound to the west of the site according to the appropriate SOP’s.

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• Removal of general skip waste (e.g., packaging not product contaminated) to the solid waste storage area.

• Create an inventory of obsolete solid chemicals, product samples and raw material samples in the laboratory and transfer to waste storage in accordance with appropriate standard operating procedures (SOP’s).

Stage 1 – Task 4: Decontaminate as required

Decontamination of all process equipment, interconnecting pipe work and storage systems will be undertaken in accordance with best practice and safe working procedures. There are SOPs on site, specific for the clean down of reactor groups and ancillary equipment.

Most liquid streams would be discharged directly to the process effluent drainage network, transferred to the on-site wastewater treatment plant (WWTP) and the treated effluent discharged to the sewer under the terms of the IPPC License.

Process wastewater containing hazardous materials and which may not be suitable for treatment in the WWTP may be produced during specific cleaning operations. This contaminated wastewater will be collected in accordance with present site procedures, and stored in suitable containers on-site prior to disposal off-site by approved waste contractors.

Contaminated solid waste arising from wipe-downs of equipment etc. will be collected in drums as hazardous waste and disposed off-site accordingly.

Stage 1 - Task 5: Decontamination Testing

Designed on a case by case basis, a testing protocol will be implemented to include sampling of representative areas of the cleaned plant/equipment using wipe/swab sampling of the equipment, followed by analysis for the detection of the various APIs. The acceptance criteria for the cleaning process and the subsequent classification of equipment as non-hazardous material for reuse/recycling/disposal are that the level of API must be below the limits of detection for the test method for individual APIs.

Equipment/plant which does not meet the required criteria will be disposed off-site as hazardous waste using licensed waste management contractors.

Stage 1 - Task 6: Transfer of production liquid wastes

There are four general classifications of liquid waste from production:

• strong stream;

• weak stream; and

• high calorific value (CV) organic distillates used on-site in Boiler A to generate steam for the site.

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• liquid waste (20-99% solvent) sent off-site for disposal/recovery.

Strong streams mainly comprise 10 to 15% solvent in water, dissolved solids and suspended solids. Such a liquid waste is generated as mother liquor during filtration steps or as initial rinses derived from reactor group cleaning activities (see Task 3). Strong stream liquid will be transferred from production in one of three ways:

• Transfer to strong stream effluent tank via dedicated pipe work for treatment in the WWTP.

• Transfer to solvent waste drums for storage in the drum storage area (this is the only method of strong effluent transfer from the pilot plant).

• Transfer of solvent waste to bulk tanker storage for off-site recovery.

• The actual route of the strong streams will be dependent on the characterisation of the liquid and suitability for recovery.

Weak stream liquid effluent is derived during subsequent reactor group rinses, floor washings, scrubber liquor and from utilities. All weak stream liquids will be routed to the weak stream holding tank in the WWTP area via dedicated pipelines and floor drains. The weak stream effluent will be treated in the WWTP.

In addition to the aforementioned wastes arising from production clean downs, liquid wastes arising in the pilot plant containing active materials will be classified as hazardous waste. Hazardous liquid wastes unsuitable for release to sewer will be stored into appropriate drums and transferred to hazardous waste storage area for off-site disposal by a licensed contractor. Table 7.1.4.1 summarises the residuals expected to arise.

Stage 1 - Task 7: Isolate from steam, compressed air, heating & air conditioning (HVAC) and other utilities available

There are no specific residuals associated with this stage as this is just a physical disconnection step. However, some utilities may be retained for later decommissioning stages. At a minimum it is envisaged that the following steps will be carried out:

• Electricity: Power supplies may be isolated at the main transformer switches.

• Water: Potable water supplies to the processing area may be isolated by shutting down the pumps at the potable water break tanks.

• Steam: Steam lines can be isolated by closing the main steam distribution valves.

• Air: Air lines may be isolated by closing the main air distribution valve.

• Nitrogen: Nitrogen lines may be isolated by closing the main nitrogen distribution valves.

Stage 1 - Task 8: Isolate from low temperature coolant loop, ventilation, scrubbers and VOC abatement units

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In respect of residuals, this is likely to include:

• The isolation of secondary vent condensers and reactor jackets from the closed loop low temperature coolant supply and the draining of the methanol/water coolant back to the supply tanks.

• Once vent lines have been adequately purged, all counter current scrubbers and the activated carbon drums shall be isolated from the vent system. The sump contents, assuming relatively saturated, shall be sent to the WWTP as a ‘weak stream’. The scrubber internal surfaces and packing shall be washed with a single pass dilute caustic solution until such time as the COD of the wash solution reaches a steady-state low value.

• The vent lines to the methylene chloride removal activated carbon system shall be isolated. The carbon drums (UN approved) shall be sealed, labelled according to the appropriate SOP, and placed in the solid waste storage area.

• Removal of all HEPA and Pre-filters from ventilation to specially labelled drums and transfer to solid waste storage.

Plant Status at Completion of Stage 1

Following successful completion of Stage 1 (Tasks 1 – 8), the plant status is as follows:

• All site production equipment decontaminated and in a “safe to work” (and environmentally secure) state.

• All production related residuals transferred to storage or warehouse.

• All auxiliary systems decommissioned and working mediums, e.g. oils, removed from production buildings to storage.

Time to Complete Stage 1

Production occurs 7 days per week. It takes two to three days to complete a clean down of one reactor group. All reactor groups are cleaned in parallel and therefore, allowing contingency time, it is estimated that Stage 1 would take approximately one working week to complete utilising the full compliment of production and maintenance staff at the PIP site. This period would also incorporate timeframes for decommissioning and decontaminating of the pilot plant.

Budget Cost Estimate Stage 1

As described in Section 1.2 it is assumed that the shutdown is a well-planned and resourced event and all costs in terms of manpower will be allocated to normal plant running costs for the period in question. As a result the majority of costs associated with Stage 1 (i.e. manpower costs) are excluded from this DMP. Other costs associated with Stage 1 including the removal of the hazardous liquid wastes residuals expected to arise during Stage 1, Task 3 are included in Table 7.1.4.1 in Stage 3 – Removal of Production Related Hazardous/Non-Hazardous Wastes.

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It is anticipated that plant and equipment hire may be required for various decommissioning procedures, therefore a provisional and contingency (PC) sum in the range €50,000 may be used as necessary. Furthermore, costs associated with facility ductwork cleaning and possible disposal, which may vary and therefore a PC sum of €210,000 is provided for such work. Additional approximate costs associated with testing programme during Stage 1 Task 5 are €20,000.

7.1.3 Stage 2: Removal of Excess Raw Materials and Final Product.

Stage 2 - Task 1: Dispatch of intermediates and finished product from final production to Customers

In line with normal production scheduling, all product will be distributed and sold or dispatched to another Pfizer facility.

Stage 2 - Task 2: Shipping of Excess raw material off-site

From information supplied by the site (Purchase and Stock takes for 2010) it can be estimated that approximately 758 tonnes of raw materials would be present on site. This includes all reagents, bulk and drummed solvents, acids and bases, gases, nickel catalyst and pyrophoric materials. Raw material purchase is planned on a schedule directly related to the planned production schedule. As the date for plant shut-down will be known in advance, it is assumed that stocks of raw materials will be reduced accordingly. However for the purposes of the DMP, it is assumed that the planned reduction in stocks reduces the inventory by 80% at shut down and that the remainder is shipped from site as a hazardous waste. In the case of the gases, it is assumed that any gas remaining following production may be returned to the supplier at a minimum cost. Treating the material as a hazardous waste is the worst case scenario. In reality there will be alternative routes for this material including:

• return of raw material to suppliers (especially the nickel catalyst and pyrophoric substances);

• transfer of materials to other PIP sites in Ireland; and

• transfer of bulk solvent to recovery/recycling companies.

All of the above routes would result in considerable cost savings when compared to the hazardous waste route.

Based on an 80% reduction in inventory prior to shut-down approximately 152 tonnes of raw materials will still be on site and will require disposal.

It is assumed that the approximate 152 tonnes of raw materials are to be handled as hazardous waste. The cost to dispose of this waste is included in Table 7.1.4.1.


The warehouse, final product store and other raw materials storage areas will be clear of raw materials.

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The residuals set out above should all be removed over a 4 week period, allowing for documentation (including inventory lists) and arranging shipment.

Budget Cost Estimate Stage 2

The costs associated with Task 1 are not considered as it is assumed that shipping costs will be absorbed as part of the net value of the intermediates and products. The estimated costs for the disposal of the residuals from Task 2 are presented in Table 7.1.4.1.

7.1.4 Stage 3: Removal of Production Related Hazardous/Non-Hazardous Wastes;

At this point, all substances that can be considered waste, either hazardous or non-hazardous, will have been placed in designated areas. The waste may include raw materials (detailed in Stage 2) that cannot be returned to suppliers or sold on to interested third parties.

In the case of hazardous waste disposal, all requirements of the current IPPC Licence will be considered, especially in relation to hazardous waste that is not scheduled on the IPPC Licence. Therefore, this waste will require the prior written approval of the EPA before the waste can be removed from the site.

Stage 3 will include the following tasks:

• Administrative organisation of shipments.

• Removal of the waste in accordance with appropriate national and EU legislation.

• Administrative organisation of relevant paper work.

All waste shipments during this period will be documented according to the relevant EPA guidelines. This will facilitate the requirement to have stated criteria for proper decommissioning (see Section 5.0).

Tables 7.1.4.1 and 7.1.4.2 summarise the expected quantities of hazardous waste and non-hazardous waste respectively that are expected to be shipped from the site during decommissioning. The tonnage of waste in each case is based on approximately 20% of the amount of waste disposed annually by PIP. The annual waste disposal figures employed for this exercise were determined in consultation with the waste data for 2010.

The cost is based on a flat rate of €189 per metric tonne for transport and disposal of liquid hazardous waste and €596 per metric tonne for disposal of solid hazardous waste. A flat rate of €300 per metric tonne for transport and disposal of non hazardous waste has also been applied. These rates are based on the rates that the site was charged by their waste management contractors in 2010 and are significantly lower than the rates for 2009.

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This stage will be carried out, following a lag time of approximately one week, in parallel to the decommissioning stages. As the drum store and warehousing areas receive waste to be disposed, licensed waste disposal contractors shall remove waste for landfill, incineration or recovery. It is expected that this stage will take 6 weeks.

Cost Estimate Stage 3

The predicted costs associated with this stage are summarised in Tables 7.1.4.1 and 7.1.4.2.

Plant Status at the end of Stage 3

All production related hazardous and non-hazardous wastes removed from:

• Solid waste storage area;

• Drum storage;

• Bulk storage;

• Nickel Storage Compound;

• Pyrophoric storage; and

• High calorific value (CV) organic distillates storage.

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Table 7.1.4.1: Hazardous Waste Inventory.

Waste Type Amount (tonnes) Estimated Cost (€)

Raw Materials Note 1 152 28,728

Aqueous Mother Liquors Note 2 717 135,513

Other organic solvents Note 2 1,840 347,760

Drums (empty) note 2 33 19,668

Solids/packaging note 2 31.5 18,774

Lab smalls note 2 0.08 48

Waste fuel/diesel/lube oils note 2 1.25 236

Solid waste from TO support bed. Note 3 37 22,000

Waste not otherwise specified (incl: OBE5 material from pilot plant = 4t)Note 4

10 5,960

Spent Nickel catalyst Note 2 13.3 7,927

Batteries (Pb, Ni and Alkaline) Note 2 0.14 83

Fluorescent tubes & other mercury containing waste Note 5

0.07 42

Gas cylinders Note 2 0.28 167

TOTAL 2,836 €586,906 Note 1 – most of the raw materials are liquid (solvents), therefore disposal cost assumed €189 per tonne. Note 2 - this figure is based on 20% of each waste stream produced in 2010. Note 3 – The cost for transport and disposal of solid waste from the Thermal Oxidiser (RTO) support bed has been assumed to be €22,000. Note 4 - Whilst ever attempt to identify sources of hazardous material, it is expected that certain materials will only become apparent upon actually closure of the facility and therefore a contingency of 10 tonnes of miscellaneous hazardous material has been included.

Table 7.1.4.2: Non Hazardous Waste Inventory

Waste Type Amount (tonnes) Estimated Cost (€)

General waste Note 1 13.3 3,990

Excess Sludge Note 1 124 37,200

Timber Pallets Note 1 9.6 2,880

Fibre Kegs/Cardboard/Paper Note 1 6.5 1,950

Glass Note 1 0.67 201

Construction and Demolition Note 1 20.35 6,105

Metals Note 1 1.6 480

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TOTAL 176 €52,806 Note 1 - this figure is based on 20% of each waste stream produced in 2010.

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7.1.5 Stage 4: Contract cleaning of tanks and bunds;

Cleaning of tanks, bunds and sumps

This stage is started when bulk storage begins to be emptied and with all virgin, waste and recovered solvents removed for return or disposal.

The current tank farm consists of 34 bulk storage tanks, ranging in capacity from 15 to 60 m3. These storage tanks contain virgin solvents and liquid wastes containing solvents. There are 79 bunds and sumps on the site.

It is envisaged that a specialist contractor will provide a comprehensive cleaning service for all tanks, bunds and sumps including the capture and removal of any residual sludge.

Time to complete Stage 4

Assuming that one tank per day can be cleaned, it will take approximately 5 weeks to complete this stage and can start after 2 weeks into Stage 3 – Removal of Hazardous and Non-hazardous wastes.


The pricing provided by a cleaning contractor in Dublin at the time of writing this report is €1,500 a day for tank cleaning and €1,000 for sump cleaning. In the worst case scenario, it would take a day to clean a 200m3 tank, and approximately 3 – 5 sumps or bunds could be cleaned in a day. Therefore, in this report a flat rate price of €500 per 60m3 tank and €350 per sump or a bund is assumed.

Estimated costs for cleaning of tanks and bunds are:

• € 500 x 34 = € 17,000 for cleaning of tanks;

• € 350 x 79 = € 27,650 for cleaning of bunds and sumps; and

• € 7,500 lump sum for cleaning solvent loading and unloading system.

The total of the above sum is € 52,150.

Plant Status at the End of Stage 4

All bulk and day tanks de-commissioned to a safe state in respect of the environment, health and safety.

7.1.6 Stage 5: Removal of non-process related materials and non-hazardous wastes

This will be relatively limited in scope, comprising mainly of clearance of materials from the warehouse such as:

• Plastics and packaging;

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• Mechanical parts;

• Protective clothing;

• Miscellaneous.

These materials will be removed and disposed in accordance with legal requirements.


It is expected that this stage will take 2 weeks.


It is envisaged that a possible 1-3 tonnes of waste may arise, with an approximated €1,000 required to dispose.

7.1.7 Stage 6: Decommissioning of site services;

This stage of decommissioning will apply to the following site utilities, plus the site administration buildings:

• Refrigeration/chiller Systems;

• Boiler House (including co-incinerator);

• Thermal Oxidiser;

• Pyrophoric Charging Building;

• Condensate Tanks x 1;

• Water Treatment Systems;

• Compressed Air System x 3;

• Cooling Towers x 3;

• Nitrogen Units x 2;

• Maintenance Workshop;

• Laboratories;

• Contractors Compound;

• Administration and control rooms.

Refrigeration Systems

There are three, closed loop, refrigeration systems at PIP, Little Island. A 40% methanol, 60% water solution is refrigerated using ammonia. The methanol/water solution is

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circulated as a low temperature coolant service to reactor groups and condensers. Table 4.3 presents a summary of the quantities of methanol/water and ammonia contained in each of the three systems at any one time.

It is expected that the ammonia may be retrieved by the company who service the refrigeration systems. Should the ammonia be unsuitable for re-use, then it is likely that the ammonia would be disposed of as hazardous waste. The methanol/water solution will be removed from the re-circulation tanks into road tankers for disposal by incineration. The approximate costs for ammonia removal and methanol/water solution disposal cost estimates are provided in Table 4.3.

Table 4.3 – Residuals from Refrigeration Decommissioning

RESIDUAL ESTIMATED QUANTITY (kg)

COST TO DISPOSE (€) at € 400 per tonne

Ammonia 960 Approx. € 384

MeOH/Water 3,000 Approx. €1,200

A PC sum of €16,000 has been included for the service company who will decommission the refrigeration systems.

Boiler House (including co-incinerator)

The sites planned co-incinerator (Boiler A) will be rendered safe by a specialist external contractor to decommission the co-incinerator systems. Based on the quotes provided by specialist contractors for air abatement systems, an estimated cost of €90,000 has being included for this item. This would include the disposal costs of the chemical dosing plant but does not include any potential hazardous material which may be encountered such as asbestos rope which may be present on access hatches. The remaining gas fired boiler will be left active and will be maintained by a specialist contractor until such time as PIP operations resume or until the plant is sold to an interested third party.

Emissions to Air Abatement Systems

A variety of abatement technologies are employed at the Little Island facility, such as wet gas scrubbers and three thermal oxidizers (TO’s).

The scrubbers use various dedicated packed scrubbing columns and tanks. All scrubber components will be flushed down to the onsite WWTP and the system mothballed.

Decommissioning of the TO’s would involve the removal of the ceramic beads and refractory lining in both units and disposed of as hazardous waste. A total of 12 tonnes of media is expected to require disposal (costs are included in Table 7.1.4.1).

All rinses from the incinerator components will be directed to the onsite WWTP and the system will be mothballed.

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A specialist external contractor will be employed to decommission the waste gas abatement systems. Based on the quotes provided by the specialist contractors, an estimated cost of €90,000 has being included for this item.

Hydrogenation Systems

There are two hydrogenation systems on site. The hydrogenation systems employ either palladium catalyst or nickel catalyst. It is estimated that a total of 10 tonnes of catalyst will be removed and disposed of as hazardous waste at an estimated cost of €13,000.

An external contractor will be employed to decommission the waste gas abatement systems. An estimated cost of €20,000 has been included for this item.

Condensate Tanks

The two condensate tanks will be drained, cleaned and isolated. The condensate, if classified as hazardous will be treated as a hazardous waste for trans-frontier shipment and subsequently incinerated. The tanks will be isolated from power and utilities. An estimated cost of €10,000 is included for these items.

Water Treatment System

The water treatment systems will be rendered safe by the existing contractors who are employed to service the units. Any chemicals associated with these systems can be returned to the supplier.

The only residuals which will be disposed off during this stage are the ion exchange resins and filters used in the treatment process. A PC sum of €30,000 is included to cover the disposal of this item.

Compressors

These will be decommissioned and rendered safe by the contractors employed for maintenance purposes. The item will be offered for resale. An estimated cost of €5,000 has being included for this item.

Cooling Towers

The cooling water and the five cooling towers will be drained and isolated. The non-contact cooling water will be treated as a hazardous waste for trans-frontier shipment and subsequently incinerated. The towers will be isolated from power and utilities. An estimated cost of €20,000 is included for this item.

Nitrogen Plant

An external contractor will be employed to decommission the nitrogen generation skid and nitrogen storage tanks. An estimated cost of €10,000 has being included for this item.

Transformers

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The transformers are a significant asset and will be sold on as part of plant shutdown. The value of the transformers will offset any costs associated with their removal from the site.

Emergency/Back-up Generators

There is one back up diesel generator. This will be left active and will be maintained by a specialist contractor until such time as PIP operations resume or until the plant is sold to an interested third party.

Diesel Fire Pump

The diesel fire pumps and electrical pump will be left active and will be maintained by a specialist contractor until such time as PIP operations resume or until the plant is sold to an interested third party.

Fire Sprinkler System

The fire sprinkler systems will be left active and will be maintained by a specialist contractor until such time as PIP operations resume or until the plant is sold to an interested third party.

Laboratories

It is assumed that laboratory instruments can be sold on as assets, with decommissioning costs associated primarily with expired chemicals and laboratory waste disposal. The costs for the disposal of chemicals has been included in section 7.1.4.

Maintenance Workshop

The maintenance workshop contains some engineering equipment (welders, drills, angle grinders, etc.). All equipment will be removed from site and sold and the majority of spares will be returned to the supplier or sold. It is not envisaged that there will be any substantial cost involved however a sum of €4,000 has been included for this item.

Administration and Control Rooms

This includes the main administration building, the offices and all porta-cabins located on the site. At this stage, it is assumed that only partial administration facilities will be required for the remaining site decommissioning operations and the successful completion of the DMP. In addition to waste paper and other recyclables, a significant amount of WEEE will arise from the administration facilities. A worst case scenario would involve disposal of all electronic equipment in the administrations facilities. Current disposal/recycling and transport cost for WEEE is approximately € 145 per tonne. Approximately 10 tonnes of WEEE is expected to be found in the administration facilities. A cost of € 1,450 has been included for disposal of this.

There is also a significant quantity of WEEE located in the control rooms associated with the facility. It is estimated that there will be approximately10 tonnes of WEEE generated

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during the decommissioning of the control rooms. A cost of €1,450 has been included for this.

Items of furniture will be offered for resale.

Contractors Compound

This compound is to be removed at the cost of the contractors. However, a PC sum of €5,000 has been included for management of the removal process.

Plant Status at the Completion of Stage 6

All site utilities, labs and administration building with the exception of the WWTP, effectively decommissioned.


Utility decommissioning should not start until contract cleaning (Stage 4-5) has been completed. An overall estimate of the time to decommission all utilities is 4 weeks.


The approximate cost for the decommissioning of site services is €317,484.

7.1.8 Stage 7: Decommissioning of the Waste Water Treatment Plant

Wastewater Treatment Plant (WWTP)

All wastewater suitable for discharge to sewer generated during the shut down will undergo treatment at the site’s WWTP, in accordance with the conditions of the operating IPPC licence.

Once all effluent generated upstream of the treatment plant has been treated, the primary tasks in decommissioning the WWTP itself will be to:

1. Flush all process lines to the WWTP with fresh water (no surfactants);

2. Treat washings through treatment stages;

3. Wash the balance tanks;

4. Treat washings through treatment stages;

5. With submersible pumps or equivalent, pump aeration basin contents through clarifier, de-water sludge, and drain supernatant to the sewer;

6. Power clean clarifier;

7. Let clarifier settle, drain supernatant and de-water settled sludge;

8. Decommission de-watering facilities; and

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9. Dispose de-watered sludge.

The de-watered sludge, with an average solids content of 15%, will be disposed of as a hazardous waste. In order to dispose of all activated sludge approximately 127 tonnes of de-watered sludge will be disposed as hazardous waste.


The WWTP would be the final facility to be decommissioned.

Costs Estimate Stage 7

The principle costs in decommissioning of the WWTP are:

Cleaning and flushing of WWTP. Estimate: €25,000

Dewatered sludge: Total clarifier and aeration basin volume is approximately 2,000 m3 operating at a solids concentration of approximately 9.500 mg/l. This equates to 19 tonnes dry solids giving 127 tonnes at 15% solids. Therefore, approximate cost for disposing sludge as a hazardous waste (at €400 per tonne) is estimated at €50,800.

This gives a total budget cost estimate for the WWTP decommissioning of €75,800.

Plant Status at the End of Stage 7

Wastewater Treatment Plant decommissioned.


The wastewater treatment plant would be the final facility to be decommissioned at the end of the decommissioning process. This is because the WWTP will treat many liquid wastes arising during the decommissioning process elsewhere, the tank cleaning process and also will treat domestic effluent. The time required to decommission the utilities will be controlled by the length of time it will take to decommission the WWTP. If we allow for rinsing and flushing lines to the aeration basin, and dewatering of activated sludge then the WWTP will take approximately 5 weeks to decommission.

7.1.9 Stage 8: Removal of residual hazardous materials (Non process related)

This stage applies to the situation where there may be specific residuals associated with the building structure and plant equipment that may not be removed during an annual maintenance shutdown. This includes PCBs, radioactive wastes and fluorescent tubes but does not include for actual concrete that may be contaminated. An emergency diesel generator was installed at the site in 2004. There is an associated diesel tank which stores 5,000 litres of diesel. It is proposed to leave the diesel generator in a fully operational manner upon plant shutdown and therefore none of the 5,000 litres of diesel will be removed. The reason for this is that even under the circumstances of a plant shut-down, there would still remain a risk of fire and therefore in the event of an electrical failure during such an event, the diesel generator would be used to power the firewater pumps.

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Task 1 Remove identified hazardous materials (asbestos/PCBs etc)

There are no PCBs/PCTs or asbestos on the site.

Task 2. Remove and dispose of radioactive material and fluorescent tubing

All fluorescent tubes will be removed and stored in correct containers. The waste will then be removed for disposal by a licensed company.

It is difficult to estimate the number of fluorescent tubes that exist on the site, however €7,000 is allowed for lamp disposal.

There is one radioactive device at the site - an X-ray machine is located in the QC laboratory. An estimated cost of €5,000 has being included for the decommissioning of this unit by the manufacture/approved contractor and proper disposal of this piece of equipment and any associated cooling oils.


All hazardous residual materials removed off-site.


The overall cost estimate for removal of residual waste from the site is €12,000.


An overall estimate of the time required to decommission and remove all residual hazardous materials off-site is 1 week.

7.1.10 Stage 9: Documentation and Certification

Throughout implementation of the DMP, documentation will be generated to track progress. All residues removed from site will be recorded and final clearance certificates will be prepared as required under the terms of the IPPC licence and as required under relevant waste management regulations. A final validation report including a certificate of completion for the decommissioning management plan, for all or part of the site as necessary will be submitted to the Agency within three months of execution of the plan.

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7.2 Restoration and Aftercare Management Plan – Management of Potential Long Term Residual Soil and Groundwater Contamination

7.2.1 Introduction

A fundamental principle underpinning the DMP will be to continue to fully manage contaminated shallow groundwater, which underlies the main production site.

Through much work completed by PIP during the latter half of the 1990’s, and as a result of on-going monitoring and drain integrity testing required under the terms of the current IPPC licence, the quality of the soil and groundwater beneath much of the site has been well characterised. A brief summary of the status of the soil and groundwater condition at the site follows.

Historic releases of solvents in previously unpaved chemical storage and handling areas and from site effluent drains resulted in elevated levels of solvents in shallow groundwater beneath certain areas of the site, most notably the perched aquifer in the former Aeration Basin area to the south of P1. Historically, toluene and methyl tert-butyl ether (MTBE) were the two main contaminants of concern, based on their concentrations in the aquifer, and their perceived eco-toxicities and/or environmental persistence. Alcohols have also been observed historically at elevated levels in shallow groundwaters, but are less eco-toxic, and are much more prone to degradation.

Localised, low level groundwater contamination on the south side of P1, principally by MTBE, was related to strong and weak stream effluent drains and sumps (Sumps D and G and the Nickel Trap). There was a perched aquifer in this area within the infilled Aeration Basin of the former waste water treatment plant. The perched aquifer within the fill was separated from the main aquifer by low permeability silt and clay, which restricted the hydraulic interconnection between the two aquifers. The excavation for a new weak stream tank in early 2008 breached the basal clay layer and consequently a perched aquifer no longer exists in this area of the site.

Impacts on groundwater in down gradient wells in the deeper, main sand and gravel aquifer were noted in 2003 (MTBE concentrations between 10 and 20 mg/l in wells 201, 203, 402 and 405). Monthly monitoring of wells 201 to 203 and 402 to 405 was carried out from July 2003 to October 2007.

Groundwater remediation by pumping from two extraction wells (403 and 404) in the fill material within the perched aquifer also started in July 2003, by agreement with the Agency. Water was pumped into the strong stream effluent drainage system for treatment at the waste water treatment plant. Two additional extraction wells (501 and 503) began pumping in July 2004. Wells 501, 502 and 503 were added to the monthly monitoring programme from May 2004 to December 2006.

Remediation continued via wells 404 and 501 from 2004 to 2007 (wells 403 and 503 ran dry when pumping began from well 501). Toluene concentrations have declined below reporting limits in all monitoring wells from across the site. MTBE detections in the deeper aquifer close to the Aeration Basin of the former waste water treatment plant have

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declined to below the Dutch Indicative level for serious contamination (9.2 mg/l). Indeed, in the October 2010 monitoring round all groundwater MTBE concentrations bar one (well 203) were below the EPA’s draft Interim Guideline Value of 0.03 mg/l.

MTBE concentrations in well 404 showed no clear trend and remained elevated until July 2007, when a significant decline in MTBE concentration was recorded. This is inferred to result from replacement of the strong stream effluent system, which became operational in January 2007. Increased MTBE concentrations were recorded for well 404 in 2008 (relative to the low results in mid-late 2007). This was possibly due to ground disturbance owing to the nearby installation of the weak stream tank in early 2008. To date there is no evidence that the increase in MTBE in well 404 in 2008 has had any impact on the wider groundwater quality in the main aquifer and therefore there were no implications in terms of off-site migration of contaminants at that time. MTBE concentrations in well 404 declined during 2009 and 2010 with a concentration below the reporting limit recorded in October 2010.

In comparison to well 404, well 501 was very productive and when it was pumping had a large radius of influence, encompassing wells 403 and 503. Following the breach of the basal clay layer during excavation for the new weak stream tank in 2008, well 501 was frequently found to be dry in subsequent monitoring rounds. In May 2010 the Agency agreed that well 501 could be formally removed from the monitoring schedule.

Groundwater from beneath the PIP site discharges to Bury’s Bridge Basin, which forms the northwestern boundary of the site. Groundwater samples collected from monitoring wells adjacent to the basin (wells 301, 302), and seepage samples collected from the basin itself in 2001 suggested that there is a negligible flux of MTBE into Bury’s Bridge Basin via groundwater from the PIP site.

7.2.2 Characterisation of Potential Source areas of Chemical Release

Following plant closure, so as to avoid interference with the decommissioning and plant decontamination phase, investigation of potential source areas of chemical release would be carried out by undertaking a comprehensive intrusive investigation beneath all areas of potential concern. Undertaking a post site closure investigation also facilitates data collection at a point in time that marks the end of chemical use/transfer/storage on-site. The investigation would focus primarily on unsaturated zone soils to establish where, if anywhere, there is residual contamination above the groundwater table. Drilling inside currently inaccessible buildings and close to plant is anticipated to form a key element of this work.

A site-wide soil investigation conducted in 1998, as part of a source assessment at the site (URS report ref. 13218-097), did not identify any significant zones of residual soil contamination. For safety reasons it was not possible in 1998 to drill inside buildings, and close to buried pipelines and cables, reducing the likelihood of intersecting significant zones of contamination. Sources of releases to ground identified since 1998 (namely, the strong effluent drains on south side of P1 and the weak effluent drains on north and west sides of P1) were associated with localised defects in the effluent drainage system, which have been remedied. A programme of regular underground pipeline and sump inspection

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and repair is now in operation at the site (on a rolling three-year programme). Underground strong stream drains were removed in 2006 and removal/replacement of underground weak stream drains was completed in 2008.

The existing groundwater database for the site is comprehensive. Therefore only a relatively limited additional post-closure groundwater investigation will be needed, the scope of which will, to a degree, be dependent upon the soils investigation results. It is predicted that some groundwater monitoring wells in potential source areas (perhaps in buildings close to underground services) may be needed, but little else.

The budget required to complete a comprehensive investigation of potential source areas, including laboratory analysis, quantitative risk assessment (to derive risk based remedial goals for soils beneath the site) and risk communication is estimated to be of the order of €85,000.

7.2.3 Design/Implementation source area soil/ remediation programme (as appropriate)

The post-closure investigation may encounter shallow soil contamination, which could continue to leach to groundwater (acting as an ongoing source of groundwater contamination) or have implications with respect to the potential future use of the site. Therefore the results of the soils characterisation study will be used to establish whether soil specific corrective action will be required, something that may only be necessary to speed up the overall rate at which groundwater contaminant concentrations decrease to acceptable levels. Risk based decision making will be used to quantitatively evaluate the appropriate levels of residual soil contamination that can be left in place.

Should soil-specific corrective action be required, it can be assumed soil vapour extraction will be used to remove the low aqueous solubility components (such as toluene). The highly soluble to miscible compounds (alcohols, MTBE) are unlikely to be found in soils at concentrations that will act as long-term sources of groundwater contamination.

It is assumed carbon (Granulated Activated Carbon - GAC) adsorption would be used to collect the organic compounds within the extracted vapour streams. Spent GAC would then be shipped off-site for recovery/disposal.

The following table (Table 7.2.1) provides a summary of the key tasks to be performed to treat areas of potential soil contamination, with associated budget cost estimates. The major assumption relates to the mass of recoverable solvents in the soil.

Since there is no evidence to date that would suggest that there is a significant mass of residual soil contamination, these cost estimates are considered to be conservative. However, previous investigations have been limited in the sense that access to all potential source areas (i.e., inside buildings) was not possible.

For the purposes of this DMP, it has been assumed that a mass of 2 tonnes will need to be treated in-situ over a 12 month period. Annual modifications to the Decommissioning

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Management Plan may include more accurate costs if, in the meantime, further investigations of potential soil contamination are completed.

Table 7.2.1: Potential Source Area Soil Treatment Budget Cost Estimates

ITEM COST ESTIMATE

Soil vapour extraction wells, wellheads and delivery system. Assume approx. 5m grid

€70,000

Soil vapour extraction systems (1 units @ 500 m3/hour) €85,000

Carbon treatment of off-gas, including system supply €85,000

O&M to include all labour, laboratory analyses and power €53,000

Contingency (10%) €29,000

SUB TOTAL €322,000

7.2.4 Management of corrective action programme with post remediation monitoring

Following completion of any source area soil corrective action programme it is recognised that a period of groundwater monitoring, to prove the effectiveness of the programme, will be required.

In a site decommissioning situation, the scope of the groundwater monitoring programme would be a variation on the current biannual monitoring programme underway at PIP and would be based on the most up-to-date data available on the quality of groundwater at that time.

Assuming a total of three years monitoring until final closure, continuation of the current biannual groundwater monitoring programme and data assessment/reporting, costs are predicted to be of the order of €15,000 per year, totalling €45,000.

7.3 DMP Completion Timeframe

PIP estimates that the Closure Plan element of the DMP will take approximately 4.5 months where the majority of process area materials removal and cleaning is concerned. However, a further year may be required to complete plant and equipment decontamination and confirmatory testing.

The Restoration and Aftercare programme can occur in parallel to the Closure Plan execution but will lag the Closure Plan by approximately 12 months after completion of the Closure Plan to allow access to areas for intrusive soil investigation.

The above timeframes are subject to many variables and so will be subject to review as required.

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7.4 DMP Test Programme

It is assumed that following completion of decontamination and decommissioning operations on-site, subsequent compilation of documentation (as previously detailed in Section 5.0) and submission to the EPA and relevant authorities will be satisfactory to demonstrate successful implementation of the short-term program.

Further, it is also assumed that any ongoing soil/groundwater remediation and/or monitoring programs will demonstrate the completion of the long-term program to the satisfaction of the EPA and relevant authorities, such that a certificate of completion will be issued following completion of the DMP.

On this basis, it is assumed that documentation and communications with the EPA and relevant authorities during the course of the DMP will be sufficient to demonstrate successful completion, and as a result a test program would not be required.

7.5 Final Validation

It will be necessary to ensure independent verification of the closure plan for PIP. Therefore, the following is anticipated:

7.5.1 EPA Notification

Communication with the EPA at appropriate stages in the planned cessation activities at PIP will be important. In addition to the initial notification to the EPA of cessation of activities (or part thereof), at an appropriate time towards the end of the closure activities, PIP will seek written agreement from the EPA on exactly what is required for independent verification, or validation, of the closure plan for the site.

7.5.2 Closure Audit

PIP has assumed that the EPA will at least require, for independent closure plan verification, that a Closure Audit will be undertaken by an independent third party. The key components of that audit will be:

1. That the Closure Audit will take place towards the end of the closure activities detailed in this DMP, or post-completion of the DMP. Elements of the restoration and aftercare plan, depending on what the site investigation determines, may not at that point be completed but this will be reflected in the Closure Audit Report with plans on managing the restoration and aftercare plan.

2. The Closure Audit will take place within the confines of an exact audit boundary, which may be the entire site or part thereof;

3. The Closure Audit will consist of;

a. Pre-audit preparation, including public records assessment;

b. A detailed site tour;

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c. Interviews with management;

d. A detailed documentation review;

e. Preparation of a Closure Audit Report.

Assuming that the outcome of the closure audit is successful, the closure audit report will contain recommendations on any actions outstanding and will be submitted to the EPA within three months of the execution of the closure plan. The report will also contain a certificate of completion to the effect that the third party is satisfied that the DMP has been executed as planned and that, subject to any additional actions identified in the closure audit report, with responsibilities assigned, that PIP, as decommissioned, does not pose any significant threat of pollution of the environment.

This documentation and communications with the EPA and relevant authorities will be sufficient to demonstrate successful decommissioning of the DMP and a test programme will not be required.

The cost estimate to undertake an independent closure audit is €12,000

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8. SUMMARY OF COSTS ASSOCIATED WITH THE DMP

This section briefly summarises the costs presented in Sections 7.1 and 7.2 of this report. The summary is presented in Table 9.1 and includes all costs identified during the analysis of the Short Term and Long Term Programs.

Table 9.1 Summary of DMP Costs

ITEM DESCRIPTION COST (€)

STP. 1 Production decommissioning € 280,000

STP. 3

Production related hazardous waste disposal

Production related non-hazardous waste disposal

€586,906

€52,806

STP. 4 Cleaning of tanks and bunds € 52,150

STP. 5 Non-process related wastes € 1,000

STP. 6 Decommissioning of site services, including laboratories

€ 317,484

STP. 7 Decommissioning of the WWTP € 75,800

STP. 8 Removal of Residual Hazardous Materials € 12,000

Final validation €12,000

SUB TOTAL STP (approximate) 1,390,146

LTP.1 Investigation for potential contamination sources € 85,000

LTP.2 Source area soil corrective action € 322,000

LTP.3 Monitoring of groundwater contamination € 45,000

SUB TOTAL LTP (approximate) € 452,000

DMP TOTAL (approximate) € 1,842,146

In conclusion, in the unlikely event of site closure, it has been estimated that approximately € 1.84 million would be required to bring the site to an environmentally safe condition.

9. UNDERWRITING THE DMP – FINANCIAL PROVISIONS

In January 2011 the EPA approved the Financial Provision for IPPC Licence P0136-04 and these arrangements remain in place. Attached (Appendix C) is a copy of the Financial Provision for IPPC Licence P0136-04.

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10. REVIEW OF THE DMP

The summary of costs associated with the DMP, as presented in Section 9.0 of this report, are estimates only and are based on the information and data available at the time of compilation of the report. It is anticipated that these costs will vary as time progresses and will depend on factors, including the following:

• Site conditions;

• Legislative developments;

• Inflation.

Taking this into consideration therefore, it is important that the DMP report and associated costs are reviewed and updated to reflect the current site situation. In addition, IPPC licence requirements specify the DMP report must be reviewed on an annual basis as part of the Annual Environmental Report.

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11. LIMITATIONS

URS Ireland Limited (URS) has prepared this Report for the sole use of Pfizer Ireland Pharmaceuticals in accordance with the Agreement under which our services were performed. No other warranty, expressed or implied, is made as to the professional advice included in this Report or any other services provided by us. This Report may not be relied upon by any other party without the prior and express written agreement of URS. Unless otherwise stated in this Report, the assessments made assume that the sites and facilities will continue to be used for their current purpose without significant change. The conclusions and recommendations contained in this Report are based upon information provided by others and upon the assumption that all relevant information has been provided by those parties from whom it has been requested. Information obtained from third parties has not been independently verified by URS, unless otherwise stated in the Report.

12. COPYRIGHT

© This Report is the copyright of URS Ireland Limited. Any unauthorised reproduction or usage by any person other than the addressee is strictly prohibited.

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Appendix A - Site Locations and Layouts


FINAL

Job No: REV

26.03.08

AAS SHOWN


FIGURE 1 - SITE LOCATION

IB PH / COR

PFIZER LITTLE ISLAND

IMP/ELRA REPORT

SML

49340571

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Appendix B - Gantt Chart

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Gantt Chart

ID Stage W1 W2 W3 W4 W5 W6 W7 W8 W9 W 10 W11 W12

1 Production Decommissioning

2 Removal of Excess Materials and Final Product

3 Removal of Production Wastes

4 Contract Cleaning of Bulk Storage

5 Removal of non-process related materials and non-hazardous wastes

6 Decommissioning Site Services

7 Decommissioning of the Wastewater Treatment Plant

8 Removal of Residual Hazardous Materials

9 Documentation and Certification

Where W = week

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Appendix C - Financial Provision Licence Register No P0136-04

APPENDIX 7 Statement of Measures covering Environmental Liabilities


Pfizer Ireland Pharmaceuticals\46402006 Pfizer Anninfo RMP ELRA 2010\DURP0002/JAG/JAG

ELRA update 2011

Environmental Liabilities Risk Assessment

26 April 2011 Final

46402011

ELRA update 2011


Pfizer Ireland Pharmaceuticals\46402006 Pfizer Anninfo RMP ELRA 2010\DURP0002/JAG/JAG 26 April 2011

Final

Project Title: ELRA update 2011

Report Title: Environmental Liabilities Risk Assessment


Report Ref:

Status: Final


Client Company Name: Pfizer ireland Pharmaceuticals

Issued By: URS Ireland Iveagh Court 6-8 Harcourt Road Dublin 2 Ireland Tel: +353 (0) 1 415 5100 Fax: +353 (0) 1 415 5101


Name Signature Date Position

Prepared by

John Grumley

26-04-2011 Project Manager

Checked & Approved by

Danny Ward

26-04-2011 Senior Project Engineer

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CONTENTS

Section Page No

1. INTRODUCTION .............................................................................................................. 1

1.1 General ............................................................................................................................. 1 1.2 Key Changes since previous ELRA update ..................................................................... 2 1.3 Environmental Liabilities Risk Assessments .................................................................... 3 1.4 Basis for the ELRA ........................................................................................................... 4 1.5 Key Assumptions.............................................................................................................. 4 1.6 Structure of the ELRA ...................................................................................................... 5 1.7 Limitations ........................................................................................................................ 5

2. OVERVIEW OF PIP ......................................................................................................... 6

2.1 Site Location ..................................................................................................................... 6 2.2 History of PIP ................................................................................................................... 6 2.3 Site and Process Description ........................................................................................... 8

3. SCREENING AND OPERATIONAL RISK ASSESSMENT .......................................... 11

3.1 General ........................................................................................................................... 11 3.2 Complexity ...................................................................................................................... 11

4. HISTORICAL ENVIRONMENTAL LIABILITIES ........................................................... 13

4.1 Releases to Air ............................................................................................................... 13 4.2 Discharges to Sewer and Surface Water ....................................................................... 13 4.3 Releases to Ground/Groundwater ................................................................................. 15 4.4 Waste Generated ........................................................................................................... 17

5. EXISTING ENVIRONMENTAL CONTROLS AT PIP .................................................... 18

5.1 General ........................................................................................................................... 18 5.2 Environmental Management .......................................................................................... 18 5.3 Releases to Atmosphere ................................................................................................ 18 5.4 Releases to Surface Water ............................................................................................ 19 5.5 Releases to Sewer ......................................................................................................... 20 5.6 Releases to Groundwater .............................................................................................. 20 5.7 Emergency Planning/Preparedness............................................................................... 21 5.8 Prevention of Fire ........................................................................................................... 21

6. SITE SPECIFIC ELRA FOR THE LITTLE ISLAND SITE ............................................. 23

6.1 General ........................................................................................................................... 23 6.2 Methodology-Risk Identification, Likelihood and Consequence .................................... 23 6.3 Identification of Risks at PIP .......................................................................................... 28 6.4 Assessment of Risks at PIP ........................................................................................... 38 6.5 Risk Prevention, Mitigation and Management ............................................................... 40

7. FINANCIAL PROVISIONS ............................................................................................ 44

7.1 Current Financial Provisions .......................................................................................... 44 7.2 Assessment of Pfizer Financial Provision ...................................................................... 45

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CONTENTS

Section Page No

8. LIMITATIONS ................................................................................................................ 47

9. COPYRIGHT .................................................................................................................. 47

APPENDIX A - FIGURES

APPENDIX B - FINANCIAL PROVISION LICENCE REGISTER NO P0136-04

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1. INTRODUCTION

1.1 General

The Pfizer Ireland Pharmaceuticals (PIP) facility, situated in Wallingstown, Little Island, County Cork, Ireland, is a manufacturer conducting chemical synthesis of bulk active ingredients for use in pharmaceutical manufacturing.

PIP was granted an Integrated Pollution Control Licence (Register Number P0136-01 by the Environmental Protection Agency (EPA) on the 20 December 1996 for the manufacture of pesticides, pharmaceutical or veterinary products and their intermediates. This licence was reviewed three times and the current Integrated Pollution Prevention and Control Licence (IPPC) (Reg. No. P0136-04) which was issued by the Environmental Protection Agency (EPA) on the 7 January 2011 for:

‘The use of a chemical or biological process for the production of basic pharmaceutical products’; and


Environmental management of the site is regulated by the conditions outlined in PIP’s Integrated Pollution Prevention and Control Licence Reg. No. P0136-04.

Condition 12.3 of the IPPC Licence requires the preparation and submittal to the Agency of an Environmental Liabilities Risk Assessment (ELRA). The specific requirements are as follows:

12.3.1 The licensee shall as part of the AER provide an annual statement as to the measures taken or adopted at the site in relation to the prevention of environmental damage, and the financial provisions in place in relation to the underwriting of costs for remedial actions following anticipated events (including closure) or accidents/incidents, as may be associated with the carrying on of the activity.

12.3.2 The Environmental Liabilities Risk Assessment (ELRA), which addresses the liabilities from past and present activities, shall be reviewed as necessary to reflect any significant change on site, and in any case every three years following initial agreement: review results are to be notified as part of the AER.

12.3.3 As part of the measures identified in Condition 12.3.1, the licensee shall, to the satisfaction of the Agency, make financial provision to cover any liabilities identified in Condition 12.3.2. The amount of indemnity held shall be reviewed and revised as necessary, but at least annually. Proof of renewal or revision of such financial indemnity shall be included in the annual ‘statement of measures’ report identified in Condition 12.3.1. The licensee shall have regard

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to the Environmental Protection Agency Guidance on Environmental Liability Risk Assessment, Residuals Management Plans and Financial Provision when implementing Conditions 12.3.1 and 12.3.2 above.

12.3.4 The licensee shall have regard to the Environmental Protection Agency Guidance on Environmental Liability Risk Assessment, Decommissioning Management Plans and Financial Provision when implementing Conditions 12.3.2 and 12.3.3 above.

Reason: To provide for adequate financing for monitoring and financial provisions for measures to protect the environment and to provide for the requirements of the Water Services Authority in accordance with Section 99E of the EPA Acts, 1992 to 2007.

The EPA Guidance Document entitled “Guidance on Environmental Liability Risk Assessment, Residuals Management Plans and Financial Provisions” (hereafter referred to the EPA Guidance Document) was used in the preparation of this Residuals Management Plan.

The original ELRA the PIP site was prepared in March 2008 and subsequently updated in 2009 and 2010.

This report presents the third ELRA update and includes the planned changes on-site over the calendar year 2010 that have impact on environmental risks.

1.2 Key Changes since previous ELRA update

A revised Integrated Pollution Prevention and Control Licence (IPPC) (Reg. No. P0136-04) was issued by the Environmental Protection Agency (EPA) on the 7 January 2011 to account for the upgrade of Boiler A to burn organic distillate as a fuel: To use organic distillate as an alternative fuel in Boiler A, the following site modifications have been incorporated into the design of the co-incinerator: Organic Distillates is collected from production on a per batch basis in a holding tank for use as a fuel in Boiler A. A new feed system to transport organic distillate to the boiler has been incorporated into the boiler skid. (2011). P0136-04 was updated to include the following associated activity:


The sites IPPC license was transferred from Pfizer Ireland Pharmaceuticals1 to Pfizer (NEW PIP) Holdings (Registered Number 490938).

1 ‘Pfizer Overseas Pharmaceuticals (having changed its name to Pfizer Ireland Pharmaceuticals) and C.P. Pharmaceuticals International C.V. (a limited partnership represented by and acting through Pfizer Manufacturing LLC and Pfizer Production LLC) trading as Pfizer Ireland Pharmaceuticals.

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1.3 Environmental Liabilities Risk Assessments

Any industrial site has the potential to generate environmental liabilities, i.e. damage to the environment, which must be remedied, such remediation associated with a quantifiable financial cost.

Environmental liabilities may arise from anticipated or foreseeable events, i.e. known and quantifiable releases to the environment, which arise due to the day-to-day operation of the facility. Examples of such potential liabilities include the long-term management and aftercare of a tailings pond at a mining or minerals refining site or on-site landfilling of waste materials. For a site subject to IPPC Licensing, regular emissions to air, water and land have been the subject of detailed quantification and consequence analysis, i.e. assessment of the impact of emissions, during the licence application process. The resulting IPPC licence either establishes emission limits and other conditions at levels which prevent the arising of new liabilities, or may require bonding or other secure funding mechanism to cover the expected liability. The latter case applies to, for example, on-site landfilling activities.

Environmental liabilities may also arise from unanticipated or unforeseen events. Such events may be loosely classified under the following headings:

• Events which are sudden and which are identifiable as an incident or series of related incidents which give rise to an environmental liability concurrent with the incident or shortly thereafter; and

• Events, which develop gradually or go unnoticed for a long period of time, which gradually give rise to an environmental liability.

Examples of the former would include explosion/fire or accidental release of chemicals from a storage tank to a watercourse.

An example of the latter would be leaks in underground storage tanks or transfer lines, which would result in the gradual build-up of soil and/or groundwater contamination.

The costs of dealing with unanticipated or unforeseen events are usually issues which are addressed in the insurance cover for the industrial site in question. The degree to which existing insurance policies cover environmental liabilities depends on many factors including the specific wording of the policies and legal precedence. Most Public Liability insurance policies will contain some element of cover for environmental liabilities. However, the distinction between sudden and gradual events for existing insurance policies is the subject of much debate and disagreement. There are many “grey” areas between the extremes of sudden (explosion/fire) and gradual (long-term leakage of chemicals to the groundwater system) events.

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. Based on an initial risk categorisation of the activity into Low, Medium or High risk, different approaches are recommended according to the risk category. Simple

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approaches are proposed for low risk facilities to more detailed site-specific approaches involving detailed environmental liability risk assessment for higher risk facilities.

1.4 Basis for the ELRA

The basis of this ELRA is as follows:

A review of the activities carried out at the site, including process and services; A review of the following documentation supplied by PIP:

- IPPC License Application files; - Environmental Aspects and Matrix Register; - Annual Environmental Reports between 2005 and 2010; - On-site EHS documentation; - Operational Procedures; and, - Emergency Procedures.

Publicly available information from the EPA; Identification of existing and potential hazards, including evaluation of materials

and wastes generated; and, Consideration of historic environmental incidents and remediation works

undertaken.

Based on the desk-based study research, a site inspection and discussions/workshop with the site’s Environmental Manager, a thorough assessment was made of potential environmental liabilities requiring remediation to which costs could be assigned. Remedial actions are described for these and remediation or corrective costs are identified.

1.5 Key Assumptions

There is a reasonable degree of subjectivity and uncertainty involved in Environmental Liabilities Risk Assessment so it is important to identify any assumptions at an early stage. These are as follows:

It is assumed that PIP maintains site conditions in accordance with their IPPC License. No provision has been made for costs associated with any criminal proceedings that could arise, as firstly, it is understood that there is good will and a strong desire by PIP to remain compliant with relevant legislation and the EPA requirements, and secondly, such costs are uninsurable and therefore cannot be underwritten by any third party or insurance organisation.

The ELRA has been based upon historic and current operational activities. It does not consider potential environmental liabilities associated with significant changes in use of the site, such as redevelopment for other commercial or industrial purposes by PIP or any other party, as these would require a separate risk assessment exercise should they arise.

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The ELRA includes a costing of the final clean up of the site after closure as this is set out in the Residual Management Plan (DMP), specifically catered for under Condition 10 of the IPPC License Reg. No. P0136-04.

1.6 Structure of the ELRA

The ELRA report is structured as follows:

Section 2 provides an overview of the PIP facility including details of existing process, buildings and structures present on the site at the time this report was prepared.

Section 3 describes the initial screening and operational risk assessment carried out for the PIP facility.

Section 4 provides an overview of the historical environmental liabilities at the facility.

Section 5 provides an overview of the existing measures in place at the site to minimise possible environmental liabilities associated with the facility.

Section 6 described the site specific risk assessment, which was carried out for the facility. It includes section on Risk Identification, Occurrence Likelihood, Severity Assessment, Risk Evaluation and Prevention/Mitigation.

Section 7 describes the financial provisions in place to deal with any unknown liabilities and identifies possible gaps between the level of cover provided and the level of risk associated with the facility.

Section 8 provides a summary and conclusion.

1.7 Limitations

URS has prepared this report for the sole use of PIP and for submission to the EPA in accordance with generally accepted consulting practices and for the intended purposes as stated in the agreement under which this work was completed. No other warranty, expressed or implied, is made as to the professional advice included in this report.

Unless otherwise stated in this report, the assessment assumes that the site and facilities continue to be used for their current purpose.

The conclusions and recommendations contained in this report are based upon information provided by others and the assumption that all relevant information has been provided by those relevant bodies from whom it has been requested.

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2. OVERVIEW OF PIP

2.1 Site Location

The facility is located on Little Island in Cork, Ireland, on an industrial estate shared by a number of pharmaceutical/chemical companies and various other production facilities. A site location map is shown in Figure 1. In the area surrounding the facility, the land is used as follows:

East: Showerlux, a producer of shower fixtures. Further to the east is a major development of office and light industrial facilities (Eastgate Business Park);

South: Little Island’s main road and Cara Partners, a producer of a homeopathic medicine;

West: Ellis and Bury’s Bridge Basin (surface water bodies) and Pfizer Cork Limited, a pharmaceutical company that ceased operations in 2010;

North: N25 dual carriageway.

Other nearby industrial facilities include; Janssen, Irotec and FMC - pharmaceutical companies; and, BASF, a detergent manufacturer, Henkel, manufacturers of mining ore extraction liquors and the former Mitsui Denman site, formerly a producer of manganese dioxide for batteries.

Most of the surrounding land on the island is zoned for industrial use. The island is also shared by a small number of residential properties. Within one kilometre of the facility there is a population of approximately 500 people. There is a school approximately one kilometre to the east of the facility. There is one designated Special Area of Conservation, (Great Island Channel) and one Special Protection Area (Cork harbour) located >1km south of the site. There is a small area of woodland located approximately 1.5 km to the north west of the site, and which is situated within the IPPC boundary of the Pfizer Cork Limited facility, which is classified as a proposed natural heritage area by the Cork Planning Authority owing to its value to nesting birds. There are no major tracts of agricultural land in close proximity to the site.

2.2 History of PIP

The manufacture of fine chemicals and pharmaceutical actives commenced on the site in 1978 with the commissioning of the Plaistow plant. The plant was bought by Warner Lambert in 1997 and, following the acquisition of Warner Lambert (WL) by Pfizer Incorporated in 2000, is now owned by PIP. Prior to 1978, it is understood that the site had been used for agricultural purposes.

There have been a number of site modifications since the commencement of site operations. Those modifications which are of environmental significance include:

• Site waste water treatment: new plant (1988); sludge dewatering (1994); additional oxygen input (1996); weak stream equalisation (1997); separation of

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weak/strong stream (1997); installation of new strong stream tank (1997/98); improved clarification (1998); new plant including balancing tanks, activated sludge tanks, clarifier, sludge holding tank and sludge dewatering facility (2000), strong stream process lines upgraded to an above ground system (2007).

• Firewater retention facility: re-routing of surface water drains and construction of a firewater retention pond (1996/97), and implementation of automatic pen-stock valve at firewater pond outlet controlled by continuous Total Organic Carbon (TOC) and pH monitors (1999); new surface water monitoring system prior installed which by-passes firewater retention pond and discharges directly to waters unless TOC or pH levels are exceeded (2000).

• Drum storage: construction of a paved drum storage area with secondary containment in 1992, new paved area adjacent to tank farm (1996); construction of a new drum storage building (2000).

• New production facilities: extension of production building and hydrogenation building in 1996; construction of a dryer building (2000); Durr Thermal Oxidiser (2001).

• Drain rehabilitation: programme of inspection and repair completed (1997 – 2007). Sump D repair (2003)

• Upgrade of pilot plant building: refurbishment for small scale production (2002);

• Upgrade of Tank Farm for Raw Materials and Waste Solvents: A new loading/unloading system for tankers delivering raw material and collecting waste solvent was installed (2004).

• Construction of new engineering stores: A new engineering stores was constructed. The old engineering warehouse was demolished as part of this development (2005).In 2010, the Technical Services Administration area was converted to a laboratory for the trial production of high containment products with the installation of new air handling unit, fume hoods, vessels, small reactors and receivers.

• 4 new bunds were installed in 2010, comprising:

o Caustic Storage Tank (TK521);

o Nickel ASP Storage tank (TK522);

o Waste oil Storage (TK523); and

o Laboratory waste Storage Area (TK524).

• In 2010, new portacabins were installed on the east side of the old WWTP building.

• New environmental protection measures implemented during 2010, comprise:

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o New HCl tank installed & upgrading of the HCl bund.

o Upgrading of WWTP Bunds; and

o WWTP six sigma project completed resulting in:

All 2050 polymer usage has been stopped since 01/March/2010.

A smaller blower (55kW) was installed in place of the original 160kW blower The combined electricity reduction is equivalent to an annual reduction of 647 Tonnes of Carbon Dioxide to the atmosphere.

• Upgrade of Boiler ‘A’ to burn organic distillate as a fuel: In order to reduce the consumption of indigenous fuel (natural gas), reduced carbon dioxide emissions and save costs, a project is ongoing to re-use clean organic distillates generated from production as a fuel for Boiler ‘A’. This project was the main reason for a revised IPPC licence application for the site, the revised licence (P0136-04) having been issued in January 2011. Licence P0136-04 now allows the co-incineration of these distillates with natural gas in Boiler ‘A’, subject to a range of new conditions in licence P0136-04. In order to facilitate co-incineration, modifications have been incorporated into the design of the boiler. organic distillates are collected from production on a per batch basis in a holding tank for use as a fuel in Boiler A. A new feed system to transport organic distillate to the boiler has been incorporated into the boiler skid.

• In 2010, small quantities of new products were manufactured on-site. However, this has not resulted in any substantial changes to the product profile on site. The new products comprised:

o Product S;

o Product S Crude; and

o Product T.

2.3 Site and Process Description

PIP, Wallingstown, produce bulk pharmaceutical intermediate active products in batch processes. Any one product is manufactured in well planned ‘campaigns’ (i.e., a predetermined number of batches with target yields).

• Principle raw materials used in production are:

o Intermediates from other production facilities;

o Organic and inorganic reactants;

o Organic solvents; and

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o Catalysts.

The raw materials used are generally solid and liquid with gaseous raw materials required for some products (e.g., hydrogen and ammonia).

Key equipment used includes:

• Solvent manifold systems and solids charging booths;

• Reactor vessels of varying volumetric capacity;

• Separation equipment comprising mainly centrifuges and filters;

• Driers; and

• Milling equipment.

PIP employs approximately 180 staff and 60 to 70 contractors on-site, primarily in a four-shift operation. The facility operates 24 hour per day, 7 days per week, 49 weeks per year.

The current site is comprised of approximately 4.8 hectares (48,000m2) of useable land. Current production facilities occupy approximately 8,600 m2 of the site comprising:

• two-story building, housing laboratories and administration;

• multi-story pilot plant building;

• single-story warehouse building;

• two-story production building;

• two-story utilities services building;

• main fresh solvent drum and waste storage area;

• tank farm for raw materials and waste solvents;

• an outdoors drum store, on hard standing with secondary containment;

• wastewater treatment plant;

• multi-story dryer building;

• a drum storage building;

• a fresh solvent drum plinth;

• three thermal oxidisers;

• centrifuge building; and

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• security building.

The following utilities are listed and are mainly located in the utilities building:

• Steam generation;

• Electricity from the ESB;

• Mains water from Cork County Council;

• De-ionised water generation;

• Compressed air generation;

• Nitrogen;

• Chilling systems;

• Natural gas Boiler;

• Co-incinerator; and

• Emergency diesel generator with an associated diesel tank (5000 litres).

The pilot plant building at the facility is used for the trial production of high containment products.

PIP received a Technical Amendment A to the current licence on the 15th October 2008. Technical Amendment A allows for the generation of chlorine as a by-product in a new process, commenced during 2009. Chlorine emissions are treated by a scrubber and released into the atmosphere through the Adtech Thermal Oxidiser stack (air emission point V6). However, the emissions from this process are not treated in the Adtech Thermal Oxidiser.

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3. SCREENING AND OPERATIONAL RISK ASSESSMENT

3.1 General

As a starting point in the process, a relatively simple risk assessment decision matrix can be used to classify sites according to Low, Medium and High risk and thereby select the specific ELRA and Financial Provision (FP) requirements that will be needed. The risk assessment decision matrix outlined in the EPA ELRA Guidance Document 2006 was used.

The risk assigned to the facility depends on the complexity of operations at the site, the environmental sensitivity of the receiving environment and the compliance record (compliance history) of the facility.

• Complexity – the extent and magnitude of potential hazards present due to the operation of the facility (e.g. a function of the nature of the activity, the volumes of hazardous materials stored on site etc.). A Complexity Band (G1 least complex to G5 most complex) for each class of activity has been assigned and included in a Look-Up Table (Appendix B of the EPA ELRA Guidance Document 2006).

• Environmental Sensitivity – the sensitivity of the receiving environment in the vicinity of the facility, with more sensitive locations given a higher score (e.g. the presence of aquifers below the site, groundwater vulnerability, the proximity to surface water bodies and their status, the proximity to sensitive human receptors, etc). The Environmental Sensitivity is calculated on a site-specific basis using a sub-matrix (Table 3.1).

• Compliance Record – the compliance history of the facility.

Each aspect is multiplied to give the Total Score for the facility, and this can be used to place the facility into an appropriate Risk Category as follows:

• Risk Category 1 = Score < 5

• Risk Category 2 = Score 5 - 23

• Risk Category 3 = Score = > 23.

Once this has been completed, the licensee proceeds through the relevant steps of ELRA and financial provisions that are considered appropriate for the Risk Category.

3.2 Complexity

Significant work has been done by the Environment Agency (England and Wales) in the development of the Environmental Protection Operator and Pollution Risk Appraisal (EP OPRA) methodology for classifying activities, and a similar but shortened version of this methodology has been developed for this process. Complexity Bands have where available, been derived from similar classification in the EP OPRA Complexity Score. A

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look up table for Irish activities has been included in Appendix A of the EPA’s Guidance Document.

The Complexity Band is used to determine the value used in the Operational Risk Assessments as follows:

G1 = 1, G2 = 2, G3 = 3, G4 = 4 and G5 = 5

In January 2011, PIP were granted a revised IPPC License Registration No. P0136-04. PIPs main activity is classed under section 5.16 and its associated activity is classed under section 11.1. The relevant complexity band for PIP according to the EPA Guidance Document is detailed in the table as follows:

Table 3.1 IPPC Activities and Complexity Bands IPPC Category

Activity Relevant PIP Complexity Band

5.16 the use of a chemical or biological process for the production of basic pharmaceutical products

PIP uses <2000 tonnes per annum and therefore it is assigned Complexity Band G3

11.1 The recovery of waste in a facility, within the meaning of the Act of 1996, which facility is connected or associated with another activity specified in this Schedule in respect of which a licence or revised licence under Part IV is in force or in respect of which a licence under the said Part is or will be required.

In 2011, PIP plan to use a co-incinerator to incinerator waste and therefore it is assigned Complexity Band G5

The highest complexity band assigned to PIP is G5, in accordance with the EPA guidance document a site with a complexity band of G5 is automatically assigned a risk category of 3. This infers that the overall risk of the PIP facility is high. As stated in the EPA Guidance Document, for Category 3 facilities a site specific risk assessment for such facilities is recommended, which is presented in Section 6 of this report.

As the Risk Category for the facility was automatically determined by the Complexity of the facility (i.e. G5), there is no need to carry out the remaining steps of the screening and operational risk assessment as it is already assigned to the highest risk category neither the environmental sensitivity nor the compliance history of the site will alter this.

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4. HISTORICAL ENVIRONMENTAL LIABILITIES

4.1 Releases to Air

There is no evidence to suggest that any historical releases to air, either sudden/accidental or gradual, arising from the Little Island facility have resulted in any off-site environmental liability.

With regard to sudden and accidental releases, there is no history of:

• major fires or explosions;

• run-away reactions resulting in significant discharge to atmosphere; or

• Significant accidental releases of hazardous gases.

Regular emissions via licensed sources at the site have been subject of a comprehensive monitoring programme, the results of which are forwarded to the EPA on a regular basis. No exceedances of ELV’s have been recorded in recent years.

Vegetation on and near the site is in good condition with no evidence of blight or damage due to either atmospheric quality or deposition.

The site is subject to occasional odour complaint – one in 2005 and one in 2006. All incidences are investigated and reported to the EPA.

A review of noise monitoring reports from 2004 to 2008 indicates that PIP was not discernible at noise sensitive locations during both daytime and night time. When traffic interference was absent, daytime and night time industrial noise levels at the noise sensitive locations were within the EPA limits of 55dB(A) and 45dB(A) respectively. The site has not received any noise complaints in recent years.

4.2 Discharges to Sewer and Surface Water

The receptors for both regular and any accidental releases (if they were to occur) to surface water from the site are (or have been):

• Ellis Basin – an area of marsh land to the west of the site. Prior to 1996, site surface water and uncontaminated cooling water were discharged to the Basin;

• Bury’s Bridge Basin - a shallow tidal estuary of Lough Mahon, which has been the release point for site surface water and cooling water since 1996; and

• Lough Mahon - the release point for treated effluent from the site via the IDA sewer and outfall (mixed with effluent from other industrial sites and domestic sewage) up until 2004.

Since 2004, treated effluent from the PIP site has been discharged to a Cork County Council wastewater treatment plant (WWTP) at Carrigrennan on Little Island where the effluent is further treated prior to discharge to the Lee Estuary and Lough Mahon.

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With regard to Ellis Basin, there is no evidence to suggest that releases from the site have had any significant impact or resulted in an environmental liability. A visual inspection of the basin by URS in 1997 indicated no evidence of stressed or dying vegetation. There is no history of significant accidental releases from the site to the basin.

With regard to Bury’s Bridge Basin, there has been one recorded accidental release of contaminated water to the Basin. This incident2 occurred in February 1999 when approximately 4,000 litres of a water/methanol mixture (55:45) was accidentally discharged to the surface water system and consequently to Bury’s Bridge basin. The methanol incident highlighted a number of deficiencies in the sites spill prevention and management practices/procedures. These deficiencies have now been rectified3.

Groundwater discharges to Bury’s Bridge Basin in 1998 and 1999 contained MTBE and toluene at low concentrations (<20 mg/l) however concentrations of toluene have been below detection in groundwater from this area of the site since June 1999 and MTBE concentrations have declined to trace concentrations (<0.1 mg/l in December 2004) in wells bordering Bury’s Bridge Basin. There is currently no evidence to suggest that any release from the site to the basin has resulted in an environmental liability.4

With regard to the release of treated effluent from the site, there is a comprehensive database of monitoring data on the quality of treated effluent. Difficulties have been encountered with regard to occasional exceedance of certain licensed parameters, however none of these events are considered to be significant in terms of the quality of the receiving waters. The impacts of existing discharges have been further reduced as a result of the pumping of all flows in the IDA council sewer to Carrigrennan WWTP where it is treated further prior to discharge to the Lee Estuary and Lough Mahon Cork Harbour.

Based on the review of historical incidents and existing practices on site there is no evidence to suggest that surface water or process wastewater releases from the site have resulted in the generation of any existing environmental liabilities for PIP.

2 Warner Lambert at the time submitted an incident report to the EPA for the methanol release shortly after the event.

3 A vulnerable surface water drain has now been re-routed to the effluent treatment plant and the monitoring of surface waters has been enhanced – see Section 5.4.

4 In November 2000 URS completed a surface water sampling programme in the Bury’s Bridge Basin as part of the on-going investigation and risk analysis for site groundwater contamination – see Section 5.5. The results of this sampling and analysis programme showed no appreciable risk to the flora and fauna of the Bury’s Bridge Basin (ref. URS report 13218-123\Risk Assessment).

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4.3 Releases to Ground/Groundwater

There is no history of landfilling or burial of waste material on any part of the Little Island site.

All wastes generated on-site since the commencement of site operations have been disposed of via approved non-hazardous and/or hazardous waste management contractors or as agreed with the EPA. There is no evidence to suggest that any waste generated at the Little Island site has resulted in any off-site liabilities.

There is a historical groundwater contamination issue at the site.

Releases of solvents resulted in elevated levels of several solvents in shallow groundwater beneath the site. Methyl tert-butyl ether (MTBE) is considered the main compound of concern, based on its concentration (in both the perched aquifer and in the main sand and gravel aquifer) and its environmental persistence. Toluene and alcohols have also been observed historically at elevated levels in shallow groundwaters, but are much more prone to degradation. Toluene and alcohols are no longer considered to be significant in terms of groundwater contamination of the sand and gravel aquifer at the site (though toluene is still detected in the perched aquifer in the old Aeration Basin area south of the Production Building P1).

The primary historical sources of chemical release are considered to be:

• the drum storage area (unpaved until 1992);

• toluene transfer/handling areas that were unpaved until 1996 (west side of production area);

• areas of lithium aluminium hydroxide (LAOH) cake storage (west of production area and west of bulk tank farm);

• leaking weak effluent manhole chamber (repaired Autumn 1998), in which neat toluene has been observed (west side of drum storage area);

• damaged weak effluent drain on the north side of P1, identified and repaired in September 2000); and

• a number of incidents involving damaged strong and weak effluent drain sumps and pipelines on the western and southern sides of P1, identified and repaired between 2002 and 2006.

There was a groundwater remediation system in place on the site. Groundwater was pumped from wells 404 and 501 to the weak effluent system for treatment in the site’s WWTP. Pumping had recovered significant contaminant mass. MTBE concentrations in well 501, the most productive of the two wells, had declined below the Dutch Intervention Value (DIV) in late 2005 and toluene was detected at low concentrations. A localised area of higher MTBE and toluene concentrations exists close to well 404, adjacent to Sump G where recurrent problems have been experienced in recent years.

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The excavation for the new weak stream tank in the Old Aeration Basin area in early 2008 breached the basal clay layer and consequently a perched aquifer no longer exists in this area of the site, wells screened within the former perched aquifer (wells 403 and 501) are frequently dry.

Defects in the strong stream effluent system have given rise to localised groundwater contamination, principally by MTBE and toluene, in an area of perched groundwater in the infilled former Aeration Basin. This perched aquifer is hydraulically separate from the main gravel aquifer beneath the site and only limited minor impacts on the main sand and gravel aquifer beneath the site have been noted.

Improvements in groundwater quality occurred relatively rapidly in response to removal of below-ground strong stream effluent drains and replacement with above ground pipelines in a pumped system in 2007. In addition, a strong stream sump (Sump G, adjacent to Well 404) and all the associated redundant strong streamlines discharging into this sump were removed in 2007.

Since 2007, the current management strategy for the groundwater issue is based on biannual site-wide monitoring of the main sand and gravel aquifer to track groundwater concentrations of contaminants. Monthly monitoring of wells close to the former Aeration Basin area was discontinued in October 2007 with the agreement of the Agency.

Well 404 did show elevated MTBE concentrations in October and December 2008 (relative to 2007 results). This is possibly due to ground disturbance owing to the nearby installation of the weak stream tank in early 2008. To date there is no evidence that the increase in MTBE in well 404 in 2008 has had any impact on the wider groundwater quality in the main aquifer and therefore there are no current implications in terms of off-site migration of contaminants.

The MTBE concentration in groundwater from well 404 declined in 2009 and 2010 compared to 2008 results and was below the DIV in September 2009. This supports the inference that the elevated concentrations in 2008 were due to localised disturbance in this area during the engineering works in early 2008.

To date there is no evidence that the increase in MTBE in well 404 in 2008 has had any impact on the wider groundwater quality with concentrations declining during 2009 and 2010 in the main aquifer and therefore there are no current implications in terms of off-site migration of contaminants.

A weak stream upgrade programme was completed in 2008. A new in-ground weak stream effluent collection tank was installed in the area previously occupied by the former Aeration Basin.

Overall, concentrations of MTBE have declined significantly in recent years following infrastructural improvements.

Dilution of MTBE in the estuary is predicted to be high due to tidal flushing. MTBE compound is volatile, does not bioaccumulate and no significant adverse ecological effects are predicted further up the food chain.

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In the context of regional groundwater quality issues beneath Little Island, and surface water quality in Lough Mahon, groundwater discharges from beneath the PIP Little Island site are unlikely to add significantly to the mass chemical load.

Groundwater monitoring will continue on a biannual basis as required in the site’s IPPC licence.

4.4 Waste Generated

The plant generates a number of different waste streams from production and ancillary operations. Hazardous wastes that requires disposal off-site includes off-specification product material, contaminated product, raw materials packaging, solvent wastes arising from laboratory activities and waste, which could potentially be contaminated by active pharmaceutical material from process and support operations, including filter elements, product contact items, protective clothing and laboratory waste.

General non hazardous waste on site includes uncontaminated packaging waste, and canteen and office waste. This waste is separated at source and recovery or recycling options are used where possible.

In the case of both hazardous and non hazardous waste, only properly licensed waste contractors and waste recovery or disposal facilities are used.

PIP retains records of the types and quantities of wastes being sent off site, the transport contractors, and waste facilities used for recovery or disposal.

The wastes generated at the plant are not expected to have any significant environmental impact. Wastes are held in a designated area prior to disposal and records are maintained of the nature and quantity of waste generated and the disposal method adopted.

There is no evidence to suggest that the management and disposal; of waste from the site have had any significant impact or resulted in an environmental liability.

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5. EXISTING ENVIRONMENTAL CONTROLS AT PIP

5.1 General

The PIP Little Island Facility is equipped with a high level of environmental protection systems. Ongoing care for the environment is demonstrated by the continuous upgrading of environmental protection systems/practices, and the continuous reduction of plant emissions to the environment. It has a programme of continuous improvement for a mature facility through training of people to maintain good environmental practices and replacement, upgrading, retro-fitting of equipment (as needed) to keep abreast of technological improvements.

5.2 Environmental Management

PIP operates an integrated approach to the management of environmental, health and safety aspects of the site and environmental protection has always been a key consideration. Since 1996, the site has operated under the IPC and, since September 2007, the IPPC licensing system.

Regular monitoring of emissions is carried out to ensure compliance with regulatory requirements and best practices. Monitoring is part of the site’s environmental management system, which is based on a combination of technical measures and documented environmental management programmes and procedures, whose objectives are:

• Complying with all the requirements of the site IPPC licence,

• Eliminating the risk of accidental events which could give rise to significant releases to the environment, and

• Ongoing continuous improvement of site environmental performance.

5.3 Releases to Atmosphere

The site has invested significantly in emissions to air abatement technology. The abatement systems employed are considered Best Available Technique (BAT) for the nature of activities at the site, as required by the IPPC Directive (96/61/EC) and the site’s IPPC licence.

In 2011, the site plans to operate Boiler A as a co-incinerator using organic distillate to produce site steam demand. To use organic distillate as an alternative fuel in Boiler A, the following site modifications have been incorporated into the design of the co-incinerator to ensure there is no adverse environmental impact from its operation:

• Periodic testing of the organic distillate batches will be carried out.

• Continuous Emissions Monitoring system (CEMS) will analyse the flue gas and be used as part of the control system to prevent breaches of the IPPC licence conditions.

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• Install a new burner control to ensure ELVs specified in Annex V of WID are complied with, i.e. maintaining of temperature in combustion chamber of above 850oC:

Across the remainder of the site, the main abatement equipment for emissions to air are:

• A Dust Filter Pad;

• Caustic and water scrubbers;

• A high efficiency particulate scrubber;

• A carbon adsorption unit for chlorinated solvents (only occasionally used);

• Thermal Oxidisers x 3; and

• High Efficiency Particulate Absorption (HEPA) filters.

Monitoring of emissions to atmosphere is carried out in accordance with IPPCL requirements. A preventative maintenance system is in operation at the site.

With regard to accidental releases, existing and new chemical reaction processes at the site have been subject to HAZOP to identify potential hazards and to integrate risk reduction measures (both engineering and management) into the formal manufacturing instructions.

The site operates a strict fire prevention policy and comprehensive fire-fighting system.

5.4 Releases to Surface Water

Regular releases both treated effluent and surface water, are subject to the monitoring programme as specified in Schedules 2 (iii) and 5(i) in the IPPC Licence. Emissions are reported on a monthly basis and summarised in the annual environmental report. Regular emissions are well characterised and controlled.

The main potential sources of contamination of the surface waters are spills or leaks of raw materials, intermediates, final products, process wastes or fuels from material and waste storage locations on site.

With regard to accidental releases the following measures are in place to eliminate or minimise the risk of such an event occurring and containing any such release within the site:

• HAZOPS are carried out on all process reactions and unit steps aimed at preventing accidental spills/releases etc;

• all bulk storage is contained in bund structures – subject to integrity testing every three years as required in the site’s IPPC Licence;

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• rainwater/minor spillages in the bund structures are routed to the effluent treatment plant;

• drum storage areas are within a secondary containment system which drains to the effluent treatment plant;

• all drains within the production building flow to the effluent treatment plant;

• the site operates a strict environmental incidents/spill reporting and response policy;

• the effluent treatment plant has a large hold-up/retention capacity, i.e., strong stream equalisation: 200 m3, weak stream equalisation: 900 m3;

• all surface water from the site drains through 2 oil interceptors which are continuously monitored for both TOC and pH. TOC and pH are also monitored at the final sump prior to discharge. From here surface water drains directly to Bury’s Bridge Basis via two emission points SW2 and SW3. Should either the TOC or pH set points be exceeded in the oil interceptors or the final sump, then all surface water will automatically divert to the firewater retention pond (capacity 3,505 m3). The contents of the firewater retention pond may then be pumped to the effluent treatment plant.

5.5 Releases to Sewer

Process wastewater and foul effluent produced at PIP, Little Island bulk manufacturing facility, is treated at the on-site wastewater treatment plant (WWTP) prior to being discharged through licensed emission point PW1 in accordance with the conditions of the existing IPPC licence (P0136-04) to Cork County Councils sewer.

5.6 Releases to Groundwater

Recent improvements to the site infrastructure have minimised the risks of any large scale releases to ground. Areas of historical release to ground have been paved, and underground process pipework has been inspected and repaired as needed. A rolling programme of process line inspection, testing and, where necessary, replacement is in operation at the site to highlight potential issues before significant (long-term) chemical releases to ground occur. Remedial works were carried out to repair or replace sumps D and G and the Nickel Trap between 2003 and 2005.

Underground strong stream effluent drains were eliminated from the Little Island site in Q1 2007 and a weak effluent drain upgrade was completed in 2008.

The groundwater monitoring well network affords good spatial coverage between the main areas of potential chemical release and Bury’s Bridge Basin. It should therefore serve as an “early warning system” in the event of any major chemical releases to ground. This minimises future risk by highlighting potential groundwater contamination issues prior to any impact on Bury’s Bridge Basin (the main downgradient receptor).

If, for instance, scheduled groundwater monitoring detected indications of a major chemical release in groundwater at the site, emergency response measures could be

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implemented, such as a groundwater interception system at the site’s downgradient boundary, to minimise the impact on the Basin. However, as stated earlier, the risks of such a release are considered to be low.

5.7 Emergency Planning/Preparedness

PIP is an establishment to which the EC (Control of Major Accident Hazards involving Dangerous Substances) Regulations, 2000 (S.I. No. 476 of 2000) apply.

PIP is considered a ‘lower tier’ establishment as defined by the above regulations.

The following are PIP’s aims and principles of action in order to reduce the potential for a major accident hazard on-site:

• Identification of major accident hazard scenarios;

• Assessment of the severity of the potential impact;

• Use of engineering controls to reduce the probability of an incident;

• Use of procedures and training;

• Preparation of emergency procedures; and

• Implementation of a safety management system (including rigorous Change Control Procedures).

5.8 Prevention of Fire

5.8.1 Procedures

PIP have Standard Operating Procedures (SOPs) and a highly trained Emergency Response Team in place to deal with Evacuation and Emergency Procedures. The SOPs are divided into the following categories:

• Emergency Response Teams and Procedures;

• Plant Emergency Team;

• Procedure on activation of alarm;

• Responsibilities in an emergency;

• Fire detection and fire fighting equipment;

• Crisis Management;

• Management team response; and

• Communications.

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5.8.2 Training

Fire training sessions are held regularly. The training covers practical fire extinguishers operations, a review of plant emergency plans for handling fire situations and fire prevention training. Fire evacuation drills are held regularly to familiarise employees with evacuation requirements and to ensure head counts are completed effectively. All shift foremen receive emergency response training.

5.8.3 Emergency Crew

The Emergency Response team provides assistance in dealing directly with the incident and bringing the situation under control. The team is specifically trained in responding to emergencies which may arise in PIP Little Island, the equipment available to deal with incidents and the actions required to be taken.

An Emergency Response Team is available on each shift consisting of operators and a shift supervisor who acts as Team Leader.

5.8.4 Equipment

The plant fire protection system consists of a sprinkler installation in all areas where flammable liquids are stored and handled. Smoke and heat detectors are installed throughout the plant. All of the systems are monitored by a fire alarm panel which provides visual and audible alarms and indicates appropriate fire zones. A dedicated fire water supply with fire pumps delivers water to sprinkler systems or fire hydrants. In addition there is a small fire station on site which contains a fire tender.

5.8.5 Storage and Handling of Flammable Materials

The plant has been designed and is operated in such a manner as to minimise the risk of fire or explosion in the storage and handling of flammable materials. Flammable materials are confined to sealed systems of vessels and pipes during processing. Bulk storage tanks are sprinkler or deluge protected. Warehousing is sprinkler protected. Rated electrical equipment is used in zoned areas, and bonding and grounding of non-conductive pipework and equipment in the process area reduces the risk of build-up of static electricity. Also, PIP have completed an ATEX Explosion Protection document.

5.8.6 Firewater Retention

In the event of a fire on site, there would be the possibility that the water used for fire fighting could become contaminated with chemicals and that this contaminated water could drain into the ground or, via the storm water system, into Bury’s Bridge Basin. To ensure that this will not happen, a system has been provided for the containment of water used for fire fighting. The firewater retention system diverts all surface water to the retention basin upon the initiation of the site fire-pumps.

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6. SITE SPECIFIC ELRA FOR THE LITTLE ISLAND SITE

6.1 General

As the facility at PIP Little Island is classed as a category 3 (Section 3) facility which infers the overall risk of the facility is high. The guidance provided in the EPA ELRA Guidance Document 2006 for such facilities was used when carrying out the remainder of this assessment.

The objectives of the ELRA are:

To identify and quantify environmental liabilities at the facility focusing on: unplanned, but possible and plausible events occurring during the operational phase;

To calculate the value of financial provisions required covering unknown liabilities;

To identify suitable financial instruments to cover each of the financial provisions; and

To provide a mechanism to encourage continuous environmental improvement through the management of potential environmental risks.

The methodology will be outlined in the proceeding section of this report. It includes a Risk Management Programme for the mitigation and management of any environmental liabilities identified at PIP. This programme is not required for the calculation or implementation of a financial provision at a facility. However, such a programme would encourage continuous environmental improvement and the reduction of environmental liabilities.

The ELRA will cover environmental risks leading to a potential or anticipated liability. Environmental risks will be deemed to cover all risks to: surface water, groundwater, atmosphere, land and human health.

6.2 Methodology-Risk Identification, Likelihood and Consequence

The following steps where undertaken as part of the site specific ELRA:

• Risk Identification

• Risk Classification (includes an Occurrence Assessment and a Severity Assessment)

• Risk Evaluation

• Risk Prevention/Mitigation

6.2.1 Risk Identification

Risks where identified on the site through a combination of:

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1. What-if analysis - A suggested method of carrying out this process is to initially identify all the ‘processes’ on site, list the hazards associated with each process, identify potential causes of failure of the processes and analyse the effect of impacts on the environment.

2. Site Visit – A one day site visit of the facility was carried out to examine all process areas, storage areas and associated utilities present at the PIP Site.

Table 6.1 Example Hazard Identification Table

Risk ID Potential Hazard Environmental Effect

1 Describe scenario for occurrence of potential liability e.g. spill of solvent from

solvent storage tank

Describe consequence of proposed scenario e.g. spill

of solvent causes contamination of surface

water.

6.2.2 Risk Classification-Occurrence Analysis

Having identified the potential risk, the likelihood of its occurrence needs to be assessed. An analysis of historical data and existing environmental controls as outlined in previous sections of this report was utilised when estimating likelihood of identified potential risks occurring at PIP.

The following table defines various likelihoods:

Table 6.2 Risk Classification Table-Occurrence

Rating/Score

Category Description Likelihood of Occurrence (%)

1 Very Low Very low chance of hazard occurring in 30 yr period 0-5

2 Low Low chance of hazard occurring in 30 yr period 5-10

3 Medium Medium chance of hazard occurring in 30 yr period 10-20

4 High High chance of hazard occurring in 30 yr period 20-50

5 Very High Very high chance of hazard occurring in 30 yr period >50

In order to determine an appropriate likelihood, the following is considered:

• When categorising the Occurrence Rating relating to a specific risk, the occurrence rating assigned must be based on the likelihood of the event occurring and resulting in an environmental incident, e.g. if assigning an occurrence rating to “failure of a storage tank resulting in contamination of surface water”, the occurrence rating is based on the risk of that failure resulting in contamination of surface water. In doing so, account must be taken of all

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mitigation measures employed to prevent that failure or release resulting in contamination of surface water, i.e. presence of a bund, presence of a surface water diversion system, etc.

• A risk would receive a low likelihood of occurrence in situations where the activity/area or equipment being assessed has been subject to HAZOP (and all issues identified closed out) and/or where multiple levels of protection have been provided to prevent, detect and or/manage a particular release from impacting on the environment.

• Conversely, a risk would receive a high likelihood of occurrence in situations where the activity/area or equipment being assessed has not been subject to HAZOP and/or is provided with a minimal level of protection.

6.2.3 Risk Classification-Severity Assessment

Once the environmental impact had been identified one of the following consequences is assigned.

Table 6.3 Risk Classification Table-Severity Criteria

Rating/Score

Category Description Cost of Remediation (€)Note 1

1 Trivial No damage or negligible change to the environment

<10,000

2 Minor Minor impact/localised or nuisance 10,000-100,000

3 Moderate Moderate damage to the environment 100,000-500,000

4 Major Severe damage to the environment 500,000-1,000,000

5 Massive Massive damage to a large area, irreversible in medium term

>1,000,000

Note 1 – Costs specific to PIP

In order to determine an appropriate cost range for each of the Severity scores above, the following aspects is considered:

• The sensitivity of the receiving environment;

• The anticipated damage that would realistically be expected to occur as a result of an incident occurring at the site; and,

• Current anticipated costs associated with remediation and clean up of any environmental liabilities generated.

When categorising the Severity Rating relating to a risk, the severity rating assigned must assume that all current mitigation measures in place have failed to prevent the discharge to the environment. e.g. if assigning a severity rating to “failure in a storage tank resulting

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in contamination of surface water”, the severity rating is based on the assumption that the material contained in the storage tank has discharged to surface waters i.e. all mitigation measures employed to prevent that failure resulting in contamination of surface water have failed, i.e. bund failure has occurred, surface water diversion system, etc.

6.2.4 Risk Evaluation

Having identified the hazard and decided on its likelihood and severity the significance of the risk is assigned. A risk score is determined by multiplying the occurrence score by the severity score. The risk scores can be tabulated in a risk matrix.

Occ

urre

nce

V. High 5

High 4

Medium 3

Low 2

V. Low 1

1 2 3 4 5

Triv

ial

Min

or

Mod

erat

e

Maj

or

Mas

sive

Severity

Where: 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.

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For all identified risks appropriate financial provision must be made to address any associated liabilities. With regard to ‘medium’ and ‘high’ risks the ELRA must detail how these risks will be minimised to acceptable levels.

6.2.5 Risk Prevention/Mitigation

Mitigation measures are assigned to each risks and each Risk Score is revised using post-mitigation severity and occurrence rankings. The risks are then re-ranked and tabulated in the risk matrix to illustrate the overall degree of risk reduction resulting from the risk mitigation measures. Where appropriate, the mitigation measures are accepted for implementation. A Risk Management Programme is then prepared for the ongoing management of risks and the implementation of risk mitigation measures. Target timeframes are also allocated for the implementation of each risk mitigation measure.

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6.3 Identification of Risks at PIP

Utilising information supplied by PIP all of the ‘processes’ on site were identified, the hazards associated with each process was listed and any potential causes of failure of the processes was identified. If any effect to the environment could be identified from the failure, the effect was analysed and this was listed as a Risk. A Risk Register was then developed which contained all of the Risks identified on site.

Each process was considered separately and a ‘what if’ analysis was utilised to identify all risks associated with the process in question. A list of risks was developed and these were entered into a Risk Register. Table 6.4 illustrates the Risk Register.

Table 6.4 PIP Risk Register

Risk ID

Potential Failure Mode

1 A spill occurring during the loading/unloading of chemical/fuel/other storage tanks on-site.

2 A failure of one of the storage tanks resulting in a spill of chemicals/waste. 3 Failure of the non-storage process tanks. 4 Loss of integrity within bunded areas. 5 Improper disposal of hazardous waste. 6 Uncontrolled release of hazardous/toxic gases to atmosphere. 7 Generation of fugitive emissions resulting in odour/air pollution. 8 Uncontrolled release of effluent to the drainage network. 9 Failure of wastewater drainage network (pipes/sumps) resulting in significant

release to ground and groundwater. 10 Failure of the aboveground transfer lines. 11 An on-site fire/explosion. 12 Spillage of large quantity of materials in production area. 13 Failure of on-site environmental control and monitoring systems. 14 Release of ozone depleting substances to atmosphere. 15 Noise generation. 16 Uncontrolled release of contaminated run-off to surface waters. 17 Contractor activity. 18 Offsite spillages during transport of waste/materials. 19 Site closure. These risks were assessed against the risk classification tables (RCTs) as provided in Table 6.2 and 6.3. The risk classification table was designed to reflect the critical levels of risk appropriate to the PIP site. Ratings, taken from a risk classification table, were applied to the severity and chance of occurrence of each risk. Table 6.5 below illustrates the assessment carried out for each risk in terms of its severity and likelihood of occurrence.

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Table 6.5 Risk Assessment

Risk ID

Process Potential Hazard Environmental Effect Occurrence Rating

Basis of Occurrence Severity Rating

Basis of Severity

1 Loading/ Unloading

Spill of diesel or chemicals, e.g. organic solvents, which migrate to surface water or ground.

Surface Water Groundwater or soil Contamination.

1 • There is a designated Drum Compound and a Waste Compound.

• Loading and unloading is automated, supervised by 2 people and takes place in designated areas which is secondary contained – slope to process drain leading to tank farm bund.

• If material did migrate to the storm water (SW) drains, there are 2 interceptors, which are continuously monitored for TOC and pH. In the event of an exceedance there is automatic diversion to the firewater retention pond.

• Level indicators on diesel tanks. • There is overfill protection on the

majority of bulk storage tanks. • Infrequent fuel deliveries.

Documented procedure at the site for fuel deliveries.

• Relevant staff are trained on materials handling and spill control techniques.

• Spill kits and MSDS’s provided. • Emergency response team on-site. • No previous incidents.

3 Costs associated with clean-up of soil and surface water contamination.

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Risk ID



Basis of Severity

2 Storage of liquid materials in bulk storage tanks.

Storage tank failure

Failure of the WWTP, with discharges to Carrigrennan WWTP in exceedance of licence limits. This could ultimately impact surface water.

2 • The Tank Farm is provided with secondary containment, constructed primarily of re-enforced concrete. Overfill protection is installed on all tanks. Storage tank service pumps are contained within their own separate bunds.

• All other bulk storage tanks are located within secondary containment (concrete bunds); retention capacity is at least 110% of the largest tanks.

• There was a one leak accident related to a HCl storage tank in 2009. No significant impact on the environment occurred.

3 Currently, there are large volume bulk storage tanks on-site, containing mainly virgin and waste organic solvents. These materials have the capacity to cause environmental damage if failure of on-site controls was to occur resulting in failure of the WWTP and discharges in excess of the IPPCL limits. Further treatment at Carrigrennan WWTP would limit the impact.

3 WWTP tanks Failure of non-storage process tanks


2 • All tanks are located over a paved surface and constructed of reinforced concrete.

• IBC storage area was bunded during 2009.

• The WWTP tanks have not been integrity tested.

3 Costs associated with clean-up of soil and surface water contamination – not likely that large quantities of potentially polluting materials would be released.

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Risk ID



Basis of Severity

4 Storage of liquid materials in bulk storage tanks.

Loss of integrity of bunded areas


1 • Bunds are integrity tested as part of IPPCL requirements. All bunds on site have passed the integrity tests.

• Bunds are visually inspected and pumped out 3 times a week, more frequently in wet weather. Any spill within the bunds would be detected and cleaned up.

• No historical incidents.

3 Currently, there are large volume bulk storage tanks on-site, containing mainly virgin and waste organic solvents. These materials have the capacity to cause environmental damage if failure of on-site controls was to occur resulting in failure of the WWTP and discharges in excess of the IPPCL limits. Further treatment at Carrigrennan WWTP would limit the impact.

5 Disposal of Hazardous Waste

Improper classification/ disposal of waste.

Surface Water Groundwater or soil Contamination. Public Health Risk if hazardous waste is disposed of in non-hazardous manner.

1 • Waste management system, Total Waste Management, in place at the site. All waste streams are classified.

• Designated Waste Storage Compound.

• DGSA trained person on site. DGSA controls in place.

• Permits and licence for all waste disposal operators are maintained on site. Auditing is performed on all waste disposal operators.

4 If a large quantity of waste was incorrectly categorised, it could result in significant financial implications for PIP.

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Risk ID



Basis of Severity

6 Production Emissions to air in excess of ELV’s or a sudden/accidental releases of highly toxic materials e.g. ammonia.

Risk to human health in surrounding area. Contamination of air.

1 • There has been minimal historical ELV exceedances regarding air emissions.

• Air abatement at the site is considered to be Best Available Technology (BAT).

• Planned use of a co-incinerator no-site in 2011.

3 Unlikely that a large quantity of material would be emitted as monitoring and control techniques employed at the plant would shut down the process causing the emission. Releases to air would be likely to have a short-term/transient impact.

7 Production /WWTP

Odourous fugitive emissions

Odour nuisance or short term air pollution

3 • HEPA filtering of production areas. • Strong and weak balance tanks

are covered. • Overfill protection (high level

alarms) on majority of bulk storage tanks. Some of bulk storage tanks vent to the thermal oxidiser.

• Occasional odour complaint received by the site, however no reoccurring odour complaint.

1 Impact would be limited to the surrounding area. Not likely to result in any significant unknown liabilities. Odour would eventually dissipate in the environment. Not likely to result in any significant health effects.

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Risk ID



Basis of Severity

8 Process wastewater handling

Accidental/ uncontrolled release of effluent to the drainage network.

Failure of on-site WWTP and discharge of untreated effluent to Carrigrennan WWTP and subsequent release to surface waters (Cork Harbour).

2 • There is SCADA control on the WWTP which is linked to the DC System. An alarm is raised at the Control Room if wastewater comes within a specific range but is also within the IPPCL limit.

• The control room is manned 24 hrs/day.

• There is an automatic shut-down of the final discharge if it is outside the temperature and pH ranges specified in the IPPCL.

• Environmentally critical equipment related to the WWTP is maintained on a weekly basis by a contractor.

2 Costs associated with remediation if risk occurred. Severity reducing owing to further treatment at Carrigrennan.

9 Disposal of wastewater

Failure of wastewater drainage network resulting in significant release to ground and groundwater.


2 • Some incidents involving damaged strong and weak effluent drain sumps and pipelines on the western and southern sides of P1. These damages were identified and repaired between 2002 and 2006.

• The strong stream effluent drainage were brought above ground in 2007.

• The weak stream effluent drainage was upgraded in 2008.

• Rolling 3-year drain integrity testing programme.

4 Severity is based mainly on potential costs associated with repair of undergrounds drains & possible soil remediation if major discharge were to occur.

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Risk ID



Basis of Severity

10 Transfer of materials

Failure of above ground chemical pipelines


1 • Visual inspections by site staff weekly.

• The majority of chemical pipelines cross over paved areas.

• No previous occurrences.

3 Severity is based mainly on potential costs associated with repair of pipelines & possible soil remediation if major discharge were to occur.

11 Any Major on-site fire or explosion.

Release of toxic and hazardous material to atmosphere, surface water, groundwater.

2 • Comprehensive control systems and maintenance programme in place to minimise the risk of fire.

• Comprehensive Emergency Response Plan in place at the site. SEVESO site, hence there’s a Major Accident Prevention Policy in place.

• All processes, equipment and techniques used on site are in line with up-to date manufacturing techniques used in the industry.

• Very high standard of fire protection and detection at the site.

• Firewater retention pond with a capacity of 3,515 m3.

4 Significant quantities of flammable materials stored at the site. No method of containing emission to air. Mitigated by dilution in air. Costs associated with groundwater and surface water remediation.

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Risk ID



Basis of Severity

12 Production Spillage of a substantial quantity of hazardous material related to production.

Risk to human health. Failure of WWTP, could ultimately impact surface water.

2 • All process drains are directed to the weak stream balance tank.

• Staff are trained in materials handling and spill control techniques.

• Spill kits and MSDS’s provided. • Emergency response team on-site. • Occurrence based on incident of

accidental releases of methanol through the cooling system to the SW from a process jacket of a reactor vessel (Q4 2007/Q1 2008). Incident rectified in February 2008.

3 If a large spillage were to migrate beyond existing containment measures, it would result in moderate damage to the environment as significant volumes of hazardous/toxic material could be contained in production runs.

13 Monitoring and Control Systems

Failure of on-site environmental control systems

Release of toxic and/or hazardous material to atmosphere and surface water.

2 • The site operates a preventative maintenance programme, PGEM’s, across the site.

• Environmentally critical equipment related to the WWTP and the thermal oxidiser are maintained on a regular basis by a contractor.

• The Control Room is manned 24 hours/day.

• CEM system is to be fitted to co-incinerator before normal operation commences.

3 Could result in moderate damage to the environment as significant volumes of hazardous/toxic material could be released if site control systems failed.

14 Use of refrigerants

Release of Ozone Depleting Substance’s (ODS’s) to atmosphere

Ozone depletion 1 • ODS survey completed. • Register of all refrigerants used on

site – there are no banned ODS in use at the site.

• Freon was recently replaced with ammonia.

1 Negligible effect on the ozone layer resulting from PIP activities.

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Risk ID



Basis of Severity

15 Use of utilities such as WWTP, HVAC, plant equipment etc.

Noise Generation

Noise Pollution 2 • Engineering controls in place. • Acoustic louvers in place in

maintenance/utilities. • No noise complaints in recent

years. • Noise survey regularly conducted,

and no issues indicated.

2 Localised impact - nuisance to locals.

16 Surface water run-off

General (non-loading /unloading) spillages resulting in contaminated surface water run-off

Contamination of surface waters

3 • Incident procedure in place on-site.

• Spill kits and training provided. • All surface water drains lead to 2

interceptors which are continuously monitored for pH and COD.

• In the event that the pH falls outside the existing IPPC Licence parameters the stormwater automatically diverts to the firewater retention tanks.

• Visual inspection of SW three times a week.

• One previous incident (1999) - water/methanol mixture was accidentally discharged to the surface water system and consequently to Bury’s Bridge basin.

3 Cost of clean up associated with clean up of Bury’s Basin. Spills likely to be small (non-bulk load)

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Risk ID



Basis of Severity

17 Contractor Activity

Various Release of toxic and/or hazardous material to atmosphere, surface water, groundwater. Noise/odour/dust/visual nuisance

2 • Approximately 45-50 contractors onsite.

• Contractor induction training in place.

• Designated contractor compound. • Waste management system in

place.

2 Nuisance to locals. Impact limited to the surrounding area.

18 Offsite transport of finished goods and waste

Accident causing release of PIP materials outside of the PIP site boundary

Release of toxic and hazardous material to atmosphere, surface water, groundwater.

2 • No previous incidents • All drivers are hazchem trained

and comply with ADR Licences. • Drivers have TREM cards and

emergency contact details. In addition, the site meets International Maritime Dangerous Goods (IMDG) requirements and qualifications.

4 Costs associated with clean-up of soil and surface water contamination.

19 Site Closure Various Various 3 • Medium chance of site closure within a 30 year period.

4 Costs associated with Site closure – See DMP.

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6.4 Assessment of Risks at PIP

6.4.1 Risk Register

The risk register below ranks the risks in order to prioritise mitigation and management measures.

Table 6.6 Risk Register ranked by Risk Score Risk ID Description Occurrence

Rating Severity Rating

Risk Score

19 Site closure. 3 4 12 16 Spillages resulting in

contaminated surface water run-off.

3 3 9

7 Odourous fugitive emissions. 3 1 3 9 Failure of Underground

drainage network. 2 4 8

11 Major fire/explosion. 2 4 8 18 Offsite spillage during

transport of waste/materials. 2 4 8

2 Bulk storage tank failure. 2 3 6 3 Failure of non-storage process

tanks. 2 3 6

12 Spillage of hazardous material in productions areas.

2 3 6

13 Failure of environmental control systems.

2 3 6

6 Emissions to atmosphere in excess of ELV’s atmosphere.

1 3 3

8 Accidental/uncontrolled release of effluent to surface water drainage system.

2 2 4

17 Contractor activity. 2 2 4 15 Noise generation. 2 2 4 5 Improper classification/

disposal of waste. 1 4 4

1 Spill from loading/unloading operations.

1 3 3

4 Bund integrity failure. 1 3 3 10 Failure of aboveground

chemical pipelines. 1 3 3

14 Release of Ozone Depleting Substance’s to atmosphere

1 1 1

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6.4.2 Risk Matrix

The risk matrix below indicates the critical nature of each risk. (Risk ID’s from the Risk Register have been used to complete this matrix.)

Table 6.7 – Risk Matrix

Occ

urre

nce

V. High 5

High 4

Medium 3 Risk ID 7 Risk ID 16

Risk ID 19

Low 2 Risk ID 8, 15, 17

Risk ID 2, 3, 12, 13

Risk ID 9, 11, 18

V. Low 1 Risk ID 14

Risk ID 1,4, 6, 10

Risk ID 5

1 2 3 4 5

Triv

ial

Min

or

Mod

erat

e

Maj

or

Mas

sive

Severity

Where: Red is a high level risk. Yellow is a medium level risk. Green (light and dark) is a low level risk. Table 6.7 above indicates that there are currently no risks identified in the red zone or yellow zones requiring priority attention. This is a result of existing environmental controls in place at the site. All risks identified are located in the green zone (light and dark) indicating that these are currently low risk. However, it is important to note that these risks are considered low risk as a result of existing controls measures employed at the site aimed at reducing/eliminating both the occurrence and where this is not possible the severity of these risks. There is a need for continuing awareness and monitoring of these risks on a regular basis.

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6.5 Risk Prevention, Mitigation and Management

The risk assessment and categorisation phase identified no red or yellow zone risk, which require immediate action. All risks were classified as the green zone risks and require monitoring on a regular basis.

However, the green zone risks may have the potential to increase to yellow or red zone risks, and where additional risk management measures are available to manage them at their current levels or reduce them further, these should be implemented if considered cost-effective.

6.5.1 Quantification of Unknown Environmental Liabilities

The costs associated with the known environmental liabilities (e.g. closure and aftercare costs and on-site contamination) for the PIP facility was calculated through the preparation and costing of the DMP (refer to Site Specific DMP prepared for PIP).

For the unknown liabilities identified in this report a financial model is necessary to estimate the environmental liability associated with these risks.

Each risk has two characteristics that are derived from the Risk Classification Tables (see Tables 6.2 and 6.3) that are used in the financial models:

• The range in probability (X-Y%) of the risk occurring

• The range in cost implications (€A-B) if the risk occurs

The requirements of the financial model must first be defined in terms of worst, most likely or best case scenarios. If the model is for the worst case scenario, then the higher end of each range is used in the calculations, if the model is for the most likely case then the median of each range is used and similarly if the best case scenario is required then the lower end of each range is used resulting in the lowest cost.

The simplest form of financial model can be based on simply multiplying the minimum, median or maximum value of each range for each risk (depending on the scenario considered) and totalling the values for each risk in the Register.

For the PIP facility the worst case scenario was calculated. Table 6.10 illustrates how the financial output for the worst case scenario is calculated.

From this, financial instruments for unknown liabilities can be selected as outlined in Section 8 of this report.

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Table 6.10 - Worst Case Scenario Financial Model

Risk ID

Potential Hazard Occurrence Rating

Likelihood of Occurrence

Range

Severity Rating

Cost Range (€)

Worst Case Probability

Worst Case Severity (€)

Worst Case Cost (€) Note 1

16 Contaminated surface water run-off 3 10-20% 3 100,000-

500,000 20% 500,000 100,000

11 Major Fire/Explosion 2 5-10% 4 500,000-

1,000,000 10% 1,000,000 100,000

18 Offsite spillage during transport of waste/products 2 5-10% 4 500,000-

1,000,000 10% 1,000,000 100,000

12 Spillage of hazardous material in the production areas 2 5-10% 3 100,000-

500,000 10% 500,000 50,000

9 Failure of underground drainage network 2 5-10% 3 100,000-

500,000 10% 500,000 50,000

3 Failure of the WWTP tanks 2 5-10% 3 100,000-

500,000 10% 500,000 50,000

13 Monitoring and control systems 2 5-10% 3 100,000-

500,000 10% 500,000 50,000

5 Improper waste disposal 1 0-5% 4 500,000-

1,000,000 5% 1,000,000 50,000

1 Loading/ Unloading 1 0-5% 3 100,000-

500,000 5% 500,000 25,000

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Risk ID

Potential Hazard Occurrence Rating

Likelihood of Occurrence

Range

Severity Rating

Cost Range (€)

Worst Case Probability

Worst Case Severity (€)

Worst Case Cost (€) Note 1

2 Storage of liquid materials in bulk storage tanks. 2 5-10% 3 100,000-

500,000 10% 500,000 50,000

4 Storage of Materials 1 0-5% 3 100,000-

500,000 5% 500,000 25,000

10 Various 1 0-5% 3 100,000-

500,000 5% 500,000 25,000

6 Production 1 0-5% 3 100,000-

500,000 5% 500,000 25,000

8 Uncontrolled release of wastewater to surface water drainage system

2 5-10% 2 10,000-100,000 10% 100,000 10,000

17 Contractor activity 2 5-10% 2 10,000-

100,000 10% 100,000 10,000

7 Odorous Fugitive Emissions 3 10-20 % 1 <10,000 20% 10,000 2,000

15 Noise Generation 2 5-10% 2 <10,000-

100,000 10% 100,000 10,000

14 Use of refrigerants 1 0-5% 1 <10,000 10% 10,000 1,000 Total worst case cost of Unknown liabilities 733,000733

,000 19 Site Closure. - - - - - - 1.84 million

Note 2 Total worst-case cost of unknown liabilities (including site closure) 2,575,146

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Note 1: The financial provision was estimated using the guidance document provided by the EPA. It is noted that this is an estimated cost potential based on estimated probability of a risk occurring and estimated magnitude of any resulting environmental liability. It is the opinion of URS that liabilities in excess of the total shown on the table above could conceivably occur and that consequently financial provision in excess of this figure be maintained by the site.

Note 2: The amount included for site closure was taken from the DMP prepared for the site in March 2011.

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7. FINANCIAL PROVISIONS

In the preceding sections we have summarised the site sensitivity, known historic environmental liabilities and the measures, both technical and managerial, currently in place to eliminate/reduce the risk of new environmental liabilities arising.

It has been concluded that the site environmental and safety management system is robust in terms of preventing the development of any new significant off-site environmental liability.

In the following section, we discuss the financial provisions at the site and whether these provisions are adequate to satisfactorily address the liabilities addressed in Section 6.

7.1 Current Financial Provisions

PIP, Little Island is a component site of PIP, which operates within Pfizer Global Supply (PGS) division of Pfizer Inc. PGS operates a global network of manufacturing sites, including both bulk manufacture and final dosage formulation facilities, together with logistics facilities, and technical support functions. The function of PGS within Pfizer Inc. organisation is to ensure the manufacture and supply of quality product to the company for ultimate distribution to the marketplace.

Pfizer Inc., which is headquartered in New York, discovers, develops, manufactures and markets leading prescription medicines and healthcare solutions, for humans and animals. Pfizer Inc. has total consolidated assets of $212 billion (USD) as at 31 December 2009 and consolidated net income in excess of $8.6 billion (USD) for the financial year ended 31 December 2009. The company is the world’s largest pharmaceutical company and recorded global revenues of US$67.8 billion in 2010.

The PIP Little Island site is a cost centre within PGS and is therefore centrally funded from Pfizer headquarters in the US. The site operates to an agreed annual budget which is set in advance and which is intended to cover projected expenditure related to site operations for that financial year.

In common with many multinational companies, Pfizer maintains a global public liability insurance providing indemnity in respect of legal liabilities arising from, for example, immediate, sudden and unforeseen discharge consequent upon an accident or due to defective drains, sewers or sanitary arrangements. The aggregate limit set for environmental liabilities in this respect is US$10,000,000 with no sub-limits for any particular type of claim and no requirement for Pfizer to assume any proportion of the costs before the indemnity applies.

The risks identified in the site-specific ELRA are most likely to arise from particular discrete and essentially sudden incidents such as fire, explosion, spillage, equipment failures, and process malfunctions. Such incidents would be detected by plant systems and would therefore be known events. Any potential environmental damage or contamination arising from such incidents would therefore be covered by the existing

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insurance arrangements. The current level of indemnity is more than adequate to cover the worst-case scenario financial model in the ELRA.

A discovery and confirmation of previously unknown environmental liabilities arising from gradually operating causes would be characterised and the costs of remediation would be estimated. Any required remediation would be funded centrally by Pfizer in a similar manner to that for DMP-associated costs. A scope of remediation work would be defined and developed, and a dossier then prepared for Pfizer central management. If approved, central funding would be released to cover the defined work. The release of funds may be structured as required to cover immediate and short-term activities, and if necessary, funds may be released over more extended time periods to cover longer-term requirements, for example over several years or as required.

On the assumption that the risks in the worst-case scenario financial model defined in the site-specific ELRA, were to give rise exclusively to previously unknown environmental liabilities to be discovered at a future time (which is highly unlikely), then it is considered that the worst-case costs of these unknown liabilities would be adequately covered by Pfizer central funding as described.

Pfizer reviews its insurance and financial arrangements on a regular basis for its ongoing and continued adequacy. Any changes or updates to such arrangements shall be described in ELRA reviews to be submitted to the Agency.

7.2 Assessment of Pfizer Financial Provision

The environmental liabilities identified and assessed in this report (refer to Section 6) are in the main unforeseen or unanticipated events that could occur suddenly as a result of an accident or failure of control systems. Other liabilities identified are the result of gradual and unforeseen discharge consequent upon failure of control systems which may result in a discharge to the environment such as leaking drains or undetected leaks in piperack systems.

Having consideration for the worst-case costs calculated in Table 6.10, a comparison of existing financial provisions presented in Section 7.1 above may be made with the type of unknown liabilities identified at the site.

Table 7.1 – Assessment of Pfizer Financial Provision

Risk Type Existing Pfizer Financial Provision

Comment

Immediate, sudden and unforeseen discharge consequent upon an accident.

Pfizer Global Insurance Pfizer Insurance coverage financially adequate to cover any liabilities identified.

Gradual unforeseen discharge consequent upon

Pfizer Central Funds This type of Financial Provision is adequate to

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failure of control systems. cover any unknown liabilities which may arise but which may not be covered under the existing Pfizer Global insurance.

Closure Restoration and Aftercare Liabilities

Pfizer Central Funds Pfizer have already used this to decommission and remediate other sites and it is deemed an adequate financial provision instrument to cover the associated costs.

Based on the assessment of the current financial provisions in place, it is considered unlikely that PIP requires any additional financial provisions beyond those currently employed by the site as detailed in Section 7.1.

In January 2011 the EPA approved the Financial Provision for IPPC Licence P0136-04 and these arrangements remain in place, this is presented in Appendix B.

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8. LIMITATIONS

URS Ireland Limited (URS) has prepared this Report for the sole use of Pfizer ireland Pharmaceuticals in accordance with the Agreement under which our services were performed. No other warranty, expressed or implied, is made as to the professional advice included in this Report or any other services provided by us. This Report may not be relied upon by any other party without the prior and express written agreement of URS. Unless otherwise stated in this Report, the assessments made assume that the sites and facilities will continue to be used for their current purpose without significant change. The conclusions and recommendations contained in this Report are based upon information provided by others and upon the assumption that all relevant information has been provided by those parties from whom it has been requested. Information obtained from third parties has not been independently verified by URS, unless otherwise stated in the Report.

9. COPYRIGHT

© This Report is the copyright of URS Ireland Limited. Any unauthorised reproduction or usage by any person other than the addressee is strictly prohibited.

ELRA update 2011



Final

Appendix A - Figures


FINAL

Job No: REV

26.03.08

AAS SHOWN


FIGURE 1 - SITE LOCATION

IB PH / COR

PFIZER LITTLE ISLAND

IMP/ELRA REPORT

SML

49340571

ELRA update 2011



Final

Appendix B - Financial Provision Licence Register No P0136-04

APPENDIX 8 Underground pipe line testing : Summary for 2010


Summary A pipeline integrity survey was initiated on all underground weak stream and foul sewer lines and associated tanks, at Pfizer Ireland Pharmaceuticals, Little Island in August 2010 and is scheduled to be completed during the site shutdown in 2011. A total of one hundred and twenty one pipelines, manholes and sumps have been tested to date with a further seven lines scheduled to be tested by the end of the site shutdown in 2011. Of the one hundred and twenty one pipelines, manholes and sumps tested the integrity of eleven weak stream lines were found to be compromised. All foul lines and associated sumps tested to date passed the integrity test. The impaired weak stream pipes were inspected to detect the fault and five have been repaired and passed a second integrity test. The remaining impaired lines have been inspected to detect the fault and are currently in the process of being repaired. None of these impairments are deemed to be of environmental significance.

Contents 1.0 Introduction 2.0 Assessment Criteria 3.0 Pipeline Testing Results by Location 4.0 Repairs 5.0 Testing of Repaired Lines Results 6.0 Conclusion

1.0 Introduction An underground pipeline survey was initiated by H & H Construction Ltd, in conjunction with a Pfizer Project Engineer in August 2010 and is scheduled for completion by the end of the site shutdown in 2011. A similar survey was carried out in 2007 and 2008 and our EPA IPPC licence requires us to carry out this survey only once every three years (P0136-04, condition 6.10). The scope of the survey consisted of initially testing the integrity of all underground weak stream and foul sewer lines and associated sumps and manholes. Any lines failing the test are repaired and tested again to ensure that any defects in these lines have been eliminated. 2.0 Assessment Criteria All underground pipes and associated sumps and manholes are leak tested by H & H Construction using the Hydrostatic Test carried out to BS 8301 standard or an Air Test in accordance with EPA Guidance Note on Storage & Transfer of Materials for Scheduled Activities” Appendix F - Section 2.3.4. These methods are defined as follows: Hydrostatic Test A plug is inserted in the lower end of the pipe. The pipe is then filled with water through a purpose made unit at the top end. Design permitting a header tank or stand pipe is connected to this fitting. The system is then topped up as required to calibrate the integrity of the pipe. The head of water should not exceed 1.5m above the invert of the pipe at the top end and not more than 4.0m above that of the lower end. The test is held for 30 mins. Air Test Where an air test is used, suitable airtight plugs were used at both ends of the pipeline. Air was pumped into the pipeline to achieve a pressure of approximately 11kPa & was held for approximately 5 minutes. The pressure was then adjusted to the test pressure of 10 kPa & held for a testing period of 5 minutes. If the pressure drop measured after the testing period was less than 0.025kPa, then the pipeline was deemed to have passed the test. Should a pipeline fail a hydrostatic or air test then a visual inspection was carried out on the pipe by means of a CCTV survey to determine the nature of the damage so that effective plans for repairs could be drawn up and the pipeline repaired promptly.

3.0 Pipeline Testing Results by Location The results of the initial survey are presented by drainage system location as follows: 3.1 Waste Drum Storage Area. 3.2 Temporary Drum Store Area. 3.3 EHS Building. 3.4 Drum Storage Areas Weak Stream System. 3.5 P2 Weak Stream System. 3.6 Tank Farm Loading Bays Area. 3.7 Tank Farm South Area. 3.8 P1 Weak Stream System. 3.9 Old Wastewater Treatment Plant Area. 3.10 OP3 and Administration Weak Stream System. 3.11 Warehouse Area. 3.12 Utilities Building. 3.13 Admin Building & Security Foul Sewer System 3.14 P2 Foul Sewer System 3.15 Contractor Compound Foul Sewer System Reference drawings FSK-2018 (Rev. 10) and FSK-2019 (Rev. 3) 3.1 Waste Drum Storage Areas Weak Stream System Table of Results Item No.

From To Result

1 South West Gullies WDS Sump Failed 2 South East Gullies WDS Sump Passed 3 North & East Gullies WDS Sump Passed 4 WDS Sump Laso Drum Store Gullies Passed 5 WDS Sump Pump Bund 501 Passed Summary of Results The underground weak stream pipelines and associated sumps from the Waste Drum Storage Areas passed the hydrostatic test accept WDS Sump to South West Gullies (see section 4.0 for details on this and subsequent repairs). 3.2 Temporary Drum Storage Areas Weak Stream System Table of Results Item No.

From To Result

6 All 4 Gullies TDS Sump Passed

Summary of Results The underground weak stream pipelines and associated sump from the Temporary Drum Storage Areas passed the hydrostatic test. 3.3 EHS Building Weak Stream System Table of Results Item No.

From To Result

7 Lab & Toilets Sump Passed 8 Floor Gullies Sump Passed Summary of Results The underground weak stream pipelines and associated sump in the EHS Building passed the hydrostatic test

3.4 Drum Storage Building Weak Stream System Table of Results Item No.

From To Result

9 Sampling Room Gully WS29 Passed 10 WS30 Laso Store Channel Passed 11 WS30 Laso Store Passed 12 WS30 Laso Store Gully Failed 13 WS31 Water Sen. Store Channel Passed 14 WS31 Water Sen. Store Gully Passed 15 WS32 Ni Catalyst Store Channel Passed 16 WS32 Ni Catalyst Store Gully Passed 17 WS33 DSB East Gully Passed 18 WS34 DSB South East Gully Passed 19 WS29 WS35 Inner Containment Passed 20 WS35 WS36 Passed 21 WS38 Unloading Bay Gully Passed 22 WS38 Forktruck Charging Room Gully Passed 23 WS38 NE Entrance Channel Passed 24 WS38 WS37 Passed 25 WS37 WS36 Passed 26 WS36 DSB Floor Gullies Passed 27 WS36 WWTP Passed 28 WS34 Manhole Passed 29 WS33 Manhole Passed 30 WS32 Manhole Passed 31 WS31 Manhole Passed 32 WS30 Manhole Passed 33 WS29 Manhole Passed Summary of Results The underground weak stream pipelines and associated manholes from the Drum Storage Areas Building passed the hydrostatic test accept the line WS30 to Laso Store Gully (see section 4.0 for details on this and subsequent repairs).

3.5 P 2 Dryer Building Weak Stream System Table of Results Item No.

From To Result

34 WS04 WS03 Passed 35 WS02 WS03 Passed 36 WS01 WS04 Passed 37 WS03 WS05 Passed 38 WS05 WS06 Passed 39 Associated gullies & Drainage channels Passed Summary of Results The underground weak stream pipelines in the P2 Dryer Building passed the hydrostatic test 3.6 Tank Farm Loading Bays Area Weak Stream System Table of Results Item No.

From To Result

40 Pyrophoric Cylinder Storage Tank Farm Sump Passed 41 Drainage Channel in Bay 3

& Oil Interceptor Sump S46 Passed

42 Gullies Sump To be tested 43 Drainage Channel Sump failed Summary of Results The underground weak stream pipelines and associated sumps in the Tank Farm Loading Bays Area passed the hydrostatic test accept the line from the Drainage Channel to Sump (see section 4.0 for details on this and subsequent repairs). The line running from the gullies to the sump will be camera surveyed to understand the piping layout prior to testing. This testing will be completed during the repair of the Drainage Channel.

3.7 Tank Farm South Areas Weak Stream System Table of Results Item No.

From To Result

44 WS26A WS26 Passed 45 WS26C WS26 Passed 46 Pyrophoric Building Channel WS26A Failed 47 Yard Drainage Channel WS26 Passed 48 Gully WS26 Passed 49 Pyrophoric Building &

WS26B WS26 Passed

50 ATC Skid Channel ATC manhole Passed 51 Bund 309 Gully Drainage Channel Passed 52 ATC manhole WS26C To be tested 53 Tank Farm ATC manhole Passed Summary of Results The underground weak stream pipelines and associated sumps from the Tank Farm South Areas passed the hydrostatic test accept the line from Pyrophoric Building Channel to WS26A (see section 4.0 for details on this and subsequent repairs). A visual inspection of the line from the ATC manhole to WS26C by CCTV will be carried out as hydrostatic and air testing of this line could not be achieved due to no access to plug points.

3.8 P1 Building Weak Stream System Table of Results Item No.

From To Result

54 Gullies WS27B Passed 55 Gullies WS27C Passed 56 Contractors Cpd Line WS27C Passed 57 WS27 WS27B Passed 58 Drainage Channel WS28A Passed 59 Drainage Channel WS28C Passed 60 Floor Gullies WS28 Passed 61 External Gully WS27 Passed 62 Gp 8 Drainage Channel Sump A Passed 63 Gp 3 & 4 & Drier Channel Sump C Passed 64 Gp 1,6 & 7 Drainage Channel Sump D Passed 65 Gp 8 Drainage Channel Sump E Passed 66 Gp 2 Floor Gullies Sump F Passed 67 Gp 10 Floor Gullies (A) Sump F Passed 68 Gp 10 Floor Gully (B) Sump F Passed 69 Gp 10 Drainage Channel Sump F Passed 70 Sump D Sump E Failed 71 Sump E WS18 Passed 72 Sump F WS19 Passed 73 Gullies A & B WS28B To be tested 74 Sump C & Gullies WS21 To be tested 75 WS26 WS21 To be tested 76 WS18 WS21 To be tested 77 WS27B Manhole Passed 78 WS27C Manhole Passed Summary of Results The underground weak stream pipelines and associated sumps from the P1 Building passed the hydrostatic test accept the line from Sump D to Sump E (see section 4.0 for details on this and subsequent repairs). The four lines still to be tested are continuous live lines which will be tested when production ceases during the site shutdown.

3.9 Old WWTP Area Weak Stream System Table of Results Item No.

From To Result

79 WS39 WS22B Failed 80 New Weak Stream Tank Old Weak Stream Tank Passed 81 Gullies & Drainage Channel WS21A Passed 82 WS21A WS21 Passed Summary of Results The underground weak stream pipelines from the Old WWTP Area passed the hydrostatic test accept the line from WS39 to WSB (see section 4.0 for details on this and subsequent repairs). 3.10 P3 and Admin. Buildings Weak Stream Area Table of Results Item No.

From To Result

83 P3 Floor Drains Passed 84 QC Labs WS13B Passed 85 WS13B WS18 Passed 86 WS18 WS19 Passed 87 WS23 WS19 Passed 88 Channel East of WS Tank WS23 Passed 89 Channel West of B402/403 WS23 Passed 90 WS24 WS23 Passed 91 DIW Drain (South Wall) WS24 Passed 92 DIW Floor Gully WS24 Passed 93 WS25 WS23 Passed 94 WS25B WS25 Passed 95 OP3 Drainage Channel WS25B Passed 96 Ops Yard Gully WS25B Passed Summary of Results All underground weak stream pipelines and associated tanks from the P and Admin. Buildings passed the hydrostatic test.

3.11 Warehouse Building Weak Stream System Table of Results Item No.

From To Result

97 Weigh Room 1 WS39 Failed 98 Weigh Room 2 WS39 Failed 99 Weigh Room 3 WS40 Failed 100 WS39 WS40 Passed 101 WS40 WS41 Failed 102 Store Room Channel WS41 Passed 103 Odourless Chem. Channel WS41 Passed 104 Water Sen. Room Channel WS line WS41 to WS43 Passed 105 WS41 WS42 Passed 106 WS42 WS43 Passed 107 WS43 Bund 303 Passed Summary of Results The underground weak stream pipelines and associated sumps from the Warehouse Building passed the hydrostatic test accept 4 lines namely the 3 weigh room lines to WS39 and WS40 and the WS40 to WS41 line (see section 4.0 for details on these and subsequent repairs). 3.12 Utilities Weak Stream System Table of Results Item No.

From To Result

108 WS11 Sump Failed 109 Utilities weak stream sump Passed Summary of Results The underground weak stream pipelines from Utilities building failed the hydrostatic test (see section 4.0 for details on this and subsequent repairs).

3.13 Administration, Security and Projects Foul Sewer System Table of Results Item No.

From To Result

110 AJ F1 Passed 111 F2B F2A Passed 112 F2A F2 Passed 113 F1 F2 Passed 114 F2 F2C Passed 115 F2C F3 Passed 116 F3 F3A Passed 117 F3A F3B Passed 118 F3B F3C Passed 119 F3C F3D Passed 120 F3D Admin AJ Passed 121 F3D F4 Passed 122 F4 F5 Passed 123 F5 F20 Passed Summary of Results All underground foul stream pipelines and associated tanks from Administration, Security and Projects passed the hydrostatic test. 3.14 P 2 Dryer Building Foul Sewer System Table of Results Item No.

From To Result

124 F6 F7 Passed 125 F7 F8 Passed 126 F8 F9 Passed 127 F9 F10 Passed Summary of Results All underground weak stream and foul pipelines and associated tanks from P2 Dryer building passed the hydrostatic test. 3.14 Contractors Compound Foul Sewer System To be tested.

4.0 Repairs From the integrity testing to date 11 lines were found to be impaired. These were inspected visually to locate the leak and a recommendation for the repair was drawn up. This is summarised below. Item No.

From To Description of Leak

Repair Work Carried Out

1 South West Gullies

WDS Sump

A small crack in one of the gullies.

Gully resealed.

12 WS30 Laso Store Gully

No visual defects detected in camera survey.

Pipe was relined.

43 Drainage Channel

Sump The joint sealer had perished in drainage channel

Sealer to be replaced.

46 Pyrophoric Building Channel

WS26A Impaired joints in drainage channel.

The drainage channel joints were cleaned and re-sealed.

70 Sump D Sump E A rough joint and an open joint were detected in camera survey.

Pipe was relined to seal these joints.

79 WS39 WS22B Camera survey showed 2 tie-in lines not in use.

Pipe was relined to seal off the tie-in connections.

97 Weigh Room 1

WS39 Impairment in lines.

It is planned to install new double contained drains that will tie-in to the existing weak stream drains to the west of the warehouse.

98 Weigh Room 2



99 Weigh Room 3



101 WS40 WS41 Impairment in lines.


108 WS11 Sump Some cracks in pipe fittings.

It is planned to repair/replace the cracked fittings & pipework.

5.0 Testing of Repaired Lines Results Item No. From To Result 1 South West Gullies WDS Sump Passed 12 WS30 Laso Store Gully Passed Pyrophoric Building

Channel WS26A Passed

43 Drainage Channel Sump To be retested in May 2011 once repairs are complete.

46 Sump D Sump E Passed 70 WS39 WS22B Passed 79 Weigh Room 1 WS39 To be retested in

July 2011 once repairs are complete.

97 Weigh Room 2 WS39 To be retested in July 2011 once repairs are complete.

98 Weigh Room 3 WS40 To be retested in July 2011 once repairs are complete.

99 WS40 WS41 To be retested in July 2011 once repairs are complete.

101 WS11 Sump To be retested in April 2011 once repairs are complete.

6.0 Conclusion Of the one hundred and twenty one pipelines, manholes and sumps integrity tested to date eleven were found to be compromised. All eleven were weak stream lines with minor defects or in areas where limited flow of aqueous materials are discharged infrequently through these pipes. Based on this it is deemed that none of the impairments are of environmental significance. Five of these lines were repaired and passed the integrity retest and six are scheduled to be repaired and retested the end of July 2011. The remaining seven untested lines are scheduled to be tested by the end of the site shutdown in 2011.

Page 1 of 10

APPENDIX 9 EMP – Report on the Progress made and proposals being developed to minimise water demand and the volume of trade effluent. Report 2010


Page 2 of 10

1.0 INTRODUCTION As part of the AER (Annual Environmental Report) Pfizer Little Island generate a report which documents the progress made and the proposals being developed to minimise water demand and the volume of trade effluent. The Pfizer Ireland Pharmaceutical plant in Little Island is an Active Pharmaceutical Ingredient facility with 250-300 personnel onsite at any given time. The facility uses a once through cooling water system, where the water passes through the heat exchangers in the production buildings and is then diverted to drain. The large volume of water consumed per annum can be attributed to the use in production of the active ingredients within the three main production buildings and sustaining the utilities systems for production usages. The total consumption in 2010 of water was 48% less than in 2009. This represents an overall consumption reduction of over 670,000 m3.

Fig.1 - Pfizer Little Island API, Wallingstown, Co. Cork, 2009 Pfizer little Island’s water balance is updated annually. The current Monitoring and Targeting (M&T) system in place enables constant tracking of the water usage per area and with each particular process. This assists operators and supervisors identify any potential fluctuations in water consumption.

Page 3 of 10

2.0 Water Sources The County Council supplies water at 4.5 barg to the site. This water is metered at the site boundary by the County Council and is billed monthly. This is the only source of water being used in the facility. 3.0 Water Users The following list is comprised of the main water users on site in order of consumption for the 2010 calendar year.

Breakdown of Towns Water Usage on the Little Island Site for 2010

Page 4 of 10

4.0 WATER FLOWRATE OVER 2009 AND 2010

Monthly Water Consumption

020000400006000080000

100000120000140000160000180000

Dec Jan

Feb Mar AprMay

June Ju

lyAug

Sept

OctNov

Month

Tota

l Wat

er

Con

sum

ptio

n

Water 2009 Water 2010

The water consumption graph illustrates the monthly water usage on site for 2009 and 2010 The change in processing on site in 2008 and use of the new processing system and three new condensers resulted in a sharp increase in water usage from Nov and Dec 2008. There was no site shutdown in 2009, this combined with increased production and the new changes referred to above in the reaction attributed to an increase in water usage versus the previous years. Three significant projects came into effect in Q4 2009 and Q1 and Q3 2010 to reduce the volume for water used on site. The effect of this is evident in the 48% drop in annual consumption. These included the installation of a tempered water loop in one train of equipment (Q4 2009) which has reduced water usage by 50m3/hr. The change of one filter dryer from water to LTC (Q4 2009). In Q1 2010 tempered water loop were implemented in 4 other equipment trains and installation and commissioning of a Cooling tower in OP3 was completed. The effect of this can be seen in the relatively low consumption in March. The increase in consumption from April to June is attributed to a change in manufacturing which required once thru cooling and the increasing ambient temperatures.

Page 5 of 10

5.0 BREAKDOWN OF WATER USAGE ON SITE

SITE TOTAL

0

20

40

60

80

100

120

140

14-Oct-09 03-Dec-09 22-Jan-10 13-Mar-10 02-May-10 21-Jun-10 10-Aug-10 29-Sep-10 18-Nov-10 07-Jan-11

Date

Flow

m3

Site Total Target

Total Flowrate to site in m3/hr

WATER USAGE @ OP3,

0

2

4

6

8

10

12

14

16


Date

Flow

m3 /h

r

OP3

Flowrate to OP3

Page 6 of 10

UTILITIES incl WWTP

0

5

10

15

20

25


Date

Flow

m3 /h

r

UTIL inc WWT

Flowrate to WWTP&Utilities

The graphs above firstly looks at the total flow rate of mains water feed into the Little Island Site and, then illustrates the breakdown of that water by area for 2010. Here the budget target flow rate of 93m3/hr is also indicated. From February 2010 onwards the effect of the implementation of the water reduction project can be clearly seen. The increase in consumption from April to June is due to changes in processing and also the increasing ambient temperature. The reduction in October is largely due to the trial run of a chiller to cooling the towns water. This resulted in a significant reduction in consumption. The top 3 users on site where water is used are detailed below along with estimated values of daily use at the end of 2010.

• Largest users of water = P1, P3 and WWTP&Utilities • P1 Total: Average usage = 68m3/hr • P3: Average usage = 2m3/hr • WWTP&Utilities: Average Daily Usage = 12m3/hr

Page 7 of 10

6.0 Projects undertaken in 2010 for the reduction in use of water. The following projects were completed in 2010

Tempered Water Loop OP1 (Group 3,4,6,7) : Once through water on four

condenser was replaced with a closed tempered water loop LTC (Low temperature Coolant), with an estimated saving of approximately 400m3 / day

Assigned to : Gary McNamara, : Q1 2010 Status : Complete Impact: Reduces flow to storm water and reduces volume of towns water used. OP3 Cooling tower: Once through cooling water to OP3 was replaced with a

Cooling tower. Assigned to : Gary McNamara, : Q1 2010 Status : Complete Impact: Reduces flow to storm water and reduces volume of towns water used.

Continuous monitoring and raise site awareness: Provide regular updates on

trends for water usage on site to key stakeholders. Assigned to :– M Madigan Status: Continuous Impact : Reduces flow to storm water & WWTP and reduce volume of towns water used Pipe Cooling Water to Vacuum Pumps in series: 3 vacuum pumps requiring

cooling water were re-piped in series instead of in parallel. This reduced the vacuum pump water consumption by 66% (6m3/hr).

Assigned to :– B Russell Status: Complete Impact : Reduces flow to storm water & WWTP and reduce volume of towns water used. Drill water well onsite: Works commenced to install a water well to provide

Water for used in the WWTP. Estimated reduction of 65000m3 per Annum Assigned to :– J Hunter Status: Q1 2011 Impact : Reduce volume of towns water used.

Page 8 of 10

.

7.0 Volume of Waste Water to WWTP Graphs No.1 illustrate the trend on site with respect to final effluent volumes being sent to the WWTP. It is evident that there was a gradual increase to Sept 2010 (12,950m3) with a decrease to December 2009 of final effluent being treated in the WWTP, with final effluent volumes reducing to approximately 6,697m3 for December. (Site Shutdown for 2 weeks in July) This trend can be contributed to:. Process changes on site The use of water for cooling. Continuous monitoring of solenoids valves on vaccum pumps.

Graph No.1 Effluent Volumes for 2010

Page 9 of 10

8.0 Future Planned projects for 2011.

Splitting Chilled Water and LTC systems: Feasibility study into having both a dedicated site Low Temperature coolant system and chilled water system. Potential for further significant reduction in water consumption and may also yield a energy saving. Assigned to :– G McNamara. Target: Q1 2012 Impact : Reduces flow to storm water and reduces volume of towns water used and reduces electrical load on site chillers

Drill water well onsite: Works commenced to install a water well to provide

Water for used in the WWTP. Estimated reduction of 65,000m3 per Annum Assigned to :– J Hunter Target: Q1 2011 Impact : Reduce volume of towns water used.

Continued Process Optimisation: Survey individual users and jacket set points

Assigned to :– M Madigan Target: Continuous Impact : Reduces flow to storm water and reduces volume of towns water used.

Raise Site Awareness: Provide regular updates on trends for water usage on

site to key stakeholders. Assigned to :– M Madigan Target: Continuous Impact : Reduces flow to storm water & WWTP and reduce volume of towns water used.

Page 10 of 10

10.0 Discussion Continuous reviews are ongoing on the Little Island site to identify areas where water usage can be minimised. These are captured as both water conservation and waste minimisation projects. As a result of these reviews a number of projects were completed in 2010 and are scheduled for 2011. These actions will be captured in the schedule of Objectives and Targets in the Environmental Management Programme for 2011.

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