Pfizer Ireland Pharmaceuticals, Little · PDF fileof bulk active ingredients for use in pharmaceutical manufacturing. ... Pfizer Ireland Pharmaceuticals, Little Island OPS 1-3 is

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Annual Environmental Report 2011

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

ANNUAL ENVIRONMENTAL REPORT 2011 ______________________________________________________________________________________

This Annual Environmental Report 2011, 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 2011, unless otherwise specified. A submission of summary information in electronic format will be made to the EPA, as requested in the guidance document.


CONTENTS Page no 1.0 INTRODUCTION

1.1 Pfizer Ireland Pharmaceuticals, Little Island 1 1.2 Site description 1 1.3 Environmental, Health and Safety Policy 3 1.4 Company Organisation 5

2.0 2010 Summary Data

2.1 Emissions to atmosphere 10 2.2 Emissions to sewer 14 2.3 Emissions to surface water 18 2.4 Non Compliances 2011 19 2.5 Waste Management 20 2.6 Ambient Monitoring 29 2.7 Agency monitoring and enforcement 30 2.8 Noise Monitoring 34 2.9 Resource consumption 52 2.10 Environmental incidents & complaints 54 2.11 Energy Efficiency Audit Report Summary 56

3.0 Environmental Management Programme Report 57

4.0 Pollution Release and Transfer Register 58 5.0 Proposals for AER period January to December 2012

5.1 Objectives and Targets 61 5.2 EMP Proposal 62 5.3 Noise monitoring programme proposal 64

Appendix

1. Ground Water Summary 2. Environmental Management Programme Report for 2011 3. Environmental Management Programme Proposal for 2012 4. Bund Integrity Report 5. Electronic PRTR 6. Review of Residuals Management Plan 7. Review of Environmental Liabilities Risk Assessment 8. Fugitive Emissions 9. Water demand and trade effluent generation minimisation 10. Assessment on the efficient use of raw materials in processes and

reduction in waste generated


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1.0 INTRODUCTION

1.1 Pfizer Ireland Pharmaceuticals, Little Island

IPPC 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


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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 alternative fuels, 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).


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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.


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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.


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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.


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Site Leadership Team

Figure 1.4.1

Seamus Fives

Site Leader

Bernard Lynch

Production Leader

Billy Oakes

LI Production Leader

Paul Fitzsimons

Quality Leader

Liam Brennan

Engineering Leader

Michael Cleere

LI Engineering Leader

Dermot Kelly

EHS Leader

Noelle Higgins

Environment Leader

Shane Horgan

Health & Safety Leader

Mark Hand

Op Ex Team Leader

Ian O’Driscoll

NPI Leader

Gerald O’Riordan

RFT Leader

Gerard O’Halloran

Supply Chain Team Leader

Brian Furlong

Supply Chain TL


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EHS Department

Figure 1.4.2


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


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2.0 2011 Summary Data 2.1 Summary of Emissions to Atmosphere

A summary of the figures recorded for emissions to atmosphere from the plant for 2011 are included in Tables 2.1.1, to 2.1.5. 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 for V46, V6, V1, V4,V5,V9 & V59. V8 was not used in 2011 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)

2010 2011

TA Luft Class 1 Organics

Monthly - -

876


Monthly 173 184

17,520


Monthly 1,024 1,473

26,280

Sulphur Dioxide

Annually

<1,095 2,716

NS1

Ammonia

Annually 8.541 306.6

NS1

HCl

Continuous 0.00 0.00

2621

Dioxins

Annually 3.504 x 10-7 1.161 x 10-6

NS1

NOx

Annually 8,103 60,444

NS1

CO

Annually 1095 <219

NS1

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

parameters


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Table 2.1.2 Adtec V6

Parameter


2010

2011

Limit

HCL Continuous <1.2kg 2,628 kg

Chlorine Continuous 0.74g 0.32g 438kg

Ammonia Annually 0.0009Kg 0.0001Kg NS1

TA Luft II Monthly <0.012Kg <0.006Kg 17,520kg

TA Luft III Monthly <0.012Kg <0.006Kg 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


2010

2011

NOx

V1

Biannually 106ppm 101ppm

V28

Biannually 88ppm 80ppm

SOx

V1

Biannually <5ppm 18ppm

V28

Biannually 8ppm <10ppm

Combustion Efficiency

V1

Biannually 95.39% 96.15%

V28

Biannually 95.70% 96.25%

Note 1: Light oil fuel or diesel oil were not used in 2010 & 2011.


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

Parameter


Concentration (mg/m3)

2010

2011

Dust from V4 Annually <0.33 0.03



Dust from

V59 Annually <0.24 0.14

Table 2.1.5 Boiler No.1 – Emissions From Test Burn : The system was operational for 1 week from the 26th to the 30th of June. It is data from these results that has been used to generate the table below.

Parameter


Licensed

Mass Emissions

(kg)

2011

Sulphur Dioxide

Continuous <0.79

TOC

Continuous 0.06

HCl

Quarterly <0.16

Dioxins

Quarterly <1 X 10-9

NOx

Continuous 14.6

CO

Continuous < 0.16

Total particulates

Continuous 0.23


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Parameter


Licensed

Mass Emissions

(kg)

HF

Quarterly <0.16

Heavy metals

Quarterly <0.003

Table 2.1.6 Contractors Employed for Air Monitoring Contractor M CERT Qualifications/

Accreditation Laboratory Standard

Axis Environmental Services

Level 2 ISO 17025

Table 2.1.7 Emergency Diesel Generator – Electrical peak Shaving Date NOx Result mg/m3 16/11/2011 4,464 08/12/2011 4,556 Note: The Electrical Peak Shavings was only run in November & December 2011.


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2.2 Summary of Emissions to Sewer A summary of the figures recorded for emissions to sewers from the plant for 2011 are included in Table 2.2.1, 2.2.2, 2.2.3 and 2.2.4. 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 2011 are presented in Table 2.4.1.

Table 2.2.1

Parameter


2010

2011

Licence Limits

pH

Daily

6.8 – 7.9 (Range)

7.03 – 7.74 (Range)

6.5-8.5 (Range)

Maximum Temperature (°C)

Daily 30 29.9

Not more than

32°C

Table 2.2.2 Toxicity Testing

Parameter


May 2011 October

2011

Vibrio fisheria 30 min EC50 (Microtox

test) Inhibition of oxygen consumpti

on by activated sludge

Biannually

<2.2 Toxic Units

<2.2 Toxic Units

Vibrio fisheria 30 min EC50 (Microtox

test)

Biannual <2 Toxic Units <2 Toxic

Units

Inhibition of oxygen

consumption by activated

sludge


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Table 2.2.3 Emissions to sewer.

Parameter


Mass Emissions (kg)

Licensed

Mass Emissions

(kg)

2010

2011

Flow

Continuous 118,677 94,477

292,000m³

COD

Daily 19,213 12,320

219,000

BOD

Weekly 1,564 950

109,500

Suspended solids

Weekly 5,825 3,937

116,800

Phosphorous

Monthly 224 411

14,600

Total Nitrogen

Monthly 1,116 1,648

29,200

Nitrogen as Ammonia

Weekly 193 12

5,840

Fats, Oils & Greases

Monthly <1187 87

5,840

Sulphate

Monthly 18,029 24,863

292,000

Chloride

Monthly 35,366 78,282

2,044,000

Total heavy metals

Annually <45.73 23.56

182.5

Aluminium

Annually <15.5 <3.3

NS1

Arsenic

Annually <0.178 <0.189

NS1

Cadmium

Annually <0.04 <0.024

NS1

Chromium

Annually 0.24 0.19

NS1

Zinc

Annually 1.59 14.63

NS1


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Parameter


Mass Emissions (kg)

Licensed

Mass Emissions

(kg)

2010

2011

Copper

Annually <12.35 <0.31

NS1

Mercury

Annually <0.01

NS1

Manganese

Annually 3.02 3.66

NS1

Nickel

Annually 3.13 3.76

NS1

Lead

Annually <0.08 <0.05

NS1

Tin


NS1

Titanium


NS1

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

parameters


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Table 2.2.4 Summary of GC Monitoring of final effluent

Analysis of final effluent for VOCs, semi-volatiles and major solvents quarterly gave results less than the detection limit, except for the following samples. Parameter Jan

Apr

May

Aug Oct

Nov

Toluene (mg/L) LOD LOD LOD LOD LOD 0.002 Cyclopentanone (mg/L)

LOD 0.002 0.009 LOD LOD LOD

Acetone (mg/L) LOD 0.018 0.027 LOD LOD LOD MTBE (mg/L) 0.870 0.004 0.001 10.00 0.026 0.005

LOD: Less than the limit of detection


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2.3 Summary of Emissions to Surface Water

A summary of the figures recorded for emissions to surface waters from the plant for 2011 are included in Table 2.3.1. Table 2.3.1 Emissions to surface water.

Parameter


Mass Emissions (kg)

2010 2011

Flow (m3)

N/S 589,551 501,688

Temperature (ºC)

Monthly 7.4 – 21.0 9.9 – 16.8

TOC

Monthly 0-150mg/l 2 0-150mg/l 2

PH

Continuous > 5 and < 9 2 > 5 and < 9 2

Visual Check / Odour

Daily All samples were clear and

odourless

Note 1 The storm water flow for 2010 and 2011 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.


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2.4 Non- Compliances for 2011 Table 2.4.1. Non-compliances for 2011 Date Non-compliance Corrective Action 16 Aug 2011 Final Effluent from WWTP,

with a 10mg/l value for MTBE exceeding our IPPC licence limit of 1mg/l of total VOC’s.

A number of resolutions have been identified to prevent re-occurrence of this issue. These include the following: 1. Standardise WWTP operations so that only

changes of <10% in RAS return rate are made at a time to make RAS concentration consistent.

2. In the event of aeration basin temperatures exceeding 35’C the feed and influent temperature is to be managed by the WWTP operator.

3. Ensure any changes made to the RAS rate are small to ensure RAS rate is consistent. In the event of a new feed being added to the plant or a significant change to the SVI’s the flux curve for the state point analysis is to be re-calculated.


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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 2.5.1 presents the yearly totals for hazardous waste and non-hazardous waste produced on site while Table 2.5.2 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 2.5.3 presents data for inclusion in the National Waste Database (NWD).


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Table 2.5.1 Details on hazardous and non- Hazardous waste produced in 2011 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

Sulphuric Acid 06 01 01 Production 0.04 Yes 0.04 D10 Indaver Antwerpen Poldervlietweg, Antwerp Phosphoric Acid 06 01 04 Production 0.203 Yes 0.203 D10 Indaver Antwerpen Poldervlietweg, Antwerp

Acids 06 01 06 Production 8.875 Yes 8.875 D10 Indaver Antwerpen Poldervlietweg, Antwerp

Other bases 06 02 05 Production 2.744 Yes

1.073 D10 Sava Brunsbuttel, Germany 0.007 R1 Blending Facility Fermoy Corrin, Fermoy Co.Cork 1.664 D10 Indaver Antwerpen Poldervlietweg, Antwerp

Aqueous washing liquors and mother liquors 07 05 01 Production 2780.498 Yes

1473.03 D10 Blending Facility Fermoy Corrin, Fermoy Co.Cork 547.84 R1 Blending Facility Fermoy Corrin, Fermoy Co.Cork 571.12 R2 Blending Facility Fermoy Corrin, Fermoy Co.Cork

41.8 D10 Pfizer Sandwich .498 D10 Sava Brunsbuttel, Germany

146.21 D10 Veolia Ellesmere Port Halogenated solvents and

mother liquors 07 05 03

Production &

Laboratory 1.722

Yes

.156 D10 Sava Brunsbuttel, Germany

.748 R2 Blending Facility Fermoy Corrin, Fermoy Co.Cork

.818 D10 Indaver Antwerpen Poldervlietweg, Antwerp Acetone for recovery 07 05 04 Production 846.52 Yes 846.52 R2 Pfizer Ringaskiddy Ringaskiddy Co.Cork Toluene for recovery 07 05 04 Production 512.50 Yes 512.50 R2 Pfizer Ringaskiddy Ringaskiddy Co.Cork MTBE for recovery 07 05 04 Production 1364.82 Yes 1364.82 R2 Pfizer Ringaskiddy Ringaskiddy Co.Cork

Other organic solvents 07 05 04 Production Yes 342.67 R2 Indaver Ireland

BIP organics ltd, Middlewich, Cheshire

709.17 D10 Indaver Antwerpen Poldervlietweg, Antwerp 1243.1 R1 Geocycle Rue de Courriere 49 – B7

ANNUAL ENVIRONMENTAL REPORT 2011 _____________________________________________________________

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(Tonnes /

Annum)

Hazardous (Yes/No)

Quantity / annum




818, Seneffe

494 R2 SRM Morecambe

SRM Morecambe, Middleton Road, Morecambe

1314.64 R2 SRM Morecambe

SRM Morecambe, Middleton Road, Morecambe

5393.84 R2 Blending Facitily Fermoy Corrin, Fermoy Co.Cork 24.23 D10 Veolia Ellesmere Port 5.27 D10 Sava Brunsbuttel, Germany

217.09 R2 Veolia Garston 527.330 R2 Sita Eco Services Almelo, Netherlands

Excess sludge 07 05 12 Waste Water

Treatment Plant

755.99

No 755.99 R1 Eras Eco

Foxhole, Youghal, Co. Cork

Solid Substances Containing dangerous

Substances 07 05 13 Production

Yes

19.344 D10 Indaver Antwerpen Poldervlietweg, Antwerp

1.166 R1

ATM `(Afvalstoffen Terminal Moerdijk BV) Moerdijk, Holland

.009 R2 Blending Facility Fermoy Corrin, Fermoy Co.Cork

.015 R2 KMK Metals Tullamore, Co. Offaly

86.303 D10 Sava Brunsbuttel, Germany

1.704 D10 Veolia Ellesmere Port


23 23


(Tonnes /

Annum)

Hazardous (Yes/No)

Quantity / annum




Waste Printer /Toner 08 03 18 Plant wide .06 No .06 R2 KMK Metals Tullamore, Co. Offaly Waste Oil 13 02 08 Maintenance .651 .651 R2 Blending Facility Fermoy Corrin, Fermoy Co.Cork

Sand and Stones 17 05 04 Projects 33.64

No 33.64 R4 Greenstar Sarsfield Court, Glanmire, Co. Cork

Medical Waste 18 01 03 Medical Room .013 Yes .013 D10 SCRL

Naas rd, Dublin 12, Dublin.

Timber Pallets

20 01 38 Plant Wide 35.04

No

21.08 R3 Veolia Forge Hill Forge Hill, Kinsale Road, Co. Cork

13.96 R3 Greenstar Sarsfield Court, Glanmire, Co. Cork

Iron and Steel 20 01 40 Plant wide 19..88 No 19.88 R4 Cork Metal Dublin Hill, Cork Metal (packaging )

15 01 04 Plant Wide 3.46 No

3.43 R4 Rehab Recycling partnership Monahan Road , Cork

.029 R4 Greenstar Sarsfield Court, Glanmire, Co. Cork

Empty packaging containing dangerous

substances 15 01 10 Production 178.59

Yes

10.527 D10 Sava Brunsbuttel, Germany 17.078 R3 Veolia ES Fermoy Corrin, Fermoy Co.Cork

116.278 R4 Veolia ES Fermoy Corrin, Fermoy Co.Cork 0.027 R1 Blending Facility Fermoy Corrin, Fermoy Co.Cork 0.456 D10 Veolia Ellesmere Port

34.219 D10 Indaver Antwerpen Poldervlietweg, Antwerp Mixed Packaging 15 01 06 Site Wide 10.48 No 10.48 R13 Greenstar

Sarsfield Court, Glanmire, Co. Cork

PPE- Filter NOS contaminated with

dangerous substances 15 02 02 Production 16.04

Yes

10.586 D10 Sava Brunsbuttel, Germany 2.915 D10 Indaver Antwerpen Poldervlietweg, Antwerp 2.535 D10 Veolia ES Fermoy Corrin, Fermoy Co.Cork


24 24


(Tonnes /

Annum)

Hazardous (Yes/No)

Quantity / annum




TV's & Monitors 16 02 13 Site Wide

1.375 Yes 1.375 R4 KMK Metals Tullamore, Co. Offaly Electrical Waste (PC's) 16 02 14 1.14 No 1.14 R4 KMK Metals Tullamore, Co. Offaly

Scrap Cables 16 02 16 Production 1.090 No 1.090 R4 KMK Metals Tullamore, Co. Offaly Inorganic Waste Containing dangerous substances

16 03 03 Production 0.094 Yes 0.1 D10 Indaver Antwerpen Poldervlietweg, Antwerp

Gases containing dangerous substances including halogens

16 05 04 Production .040 Yes .04 R4 Veolia ES Fermoy Corrin, Fermoy Co.Cork

Lab Smalls- Inorganic

16 05 07 Laboratories 0.188 Yes 0.174 D10 Sava Brunsbuttel, Germany

Yes .012 R1 Veolia Corrin, Fermoy Yes .002 R2 Veolia Corrin, Fermoy

Discarded organic

substances containing dangerous substances

16 05 08 Plant wide 0.166 Yes .004 R2 Veolia Corrin, Fermoy

Yes 0.162 D10 Sava Brunsbuttel, Germany Batteries - Ni-Cd 16 06 02 Plant wide .030 Yes .030 R4 KMK Metals Tullamore, Co. Offaly

Spent catalyst containing heavy metals - Nickel 16 08 02 Production 62.33 Yes

62.226 R4 Nickelhuette Aue GmbH Rudolf-Breitscheid-StraBe, 08280 Aue, Germany

.105 D10

Sava Brunsbuttel, Germany Contaminated spent

catalyst 16 08 07 Production .127 Yes 0.127 D10 Sava Brunsbuttel, Germany


25 25


(Tonnes /

Annum)

Hazardous (Yes/No)

Quantity / annum




Fibre Kegs/Cardboard/Paper 20 01 01 Plant Wide 8.5

No 8.5 R13 Veolia Forge Hill Forge Hill, Kinsale Road, Co. Cork

Paper and Cardboard packaging’s 15 01 01 Plant Wide 1.75


Plastic Packaging’s 15 01 02 Plant wide 2.72


Glass 20 01 02 Plant Wide 5.312

No 4.56 R13 Rehab Recylicng Partnership Monahan Road , Cork

0.752 R5 Rehab Glassco Ltd Carragh Road, Naas

Solids/Packaging (Acids) 20 01 14 Plant wide 28.02

Yes 0.005 R2 Veolia ES Fermoy Corrin, Fermoy Co.Cork Yes 7.00 /D10 Sava Brunsbuttel, Germany Yes 21.01 D10 Veolia Ellesmere Port

Solids/Packaging (Alkalines) 20 01 15 Plant wide 1.274 Yes 1.274 D10 Sava Brunsbuttel, Germany

Fluorescent tubes & other mercury containing

waste 20 01 21 Plant wide 0.616

Yes .0.616 R4 KMK Metals Tullamore, Co. Offaly Cooking oil 20 01 25 Canteen .699 No .699 R2 Blending facility Fermoy Corrin, Fermoy Co.Cork

Paints, Inks & Adhesives 20 01 27 Plant wide 1.240 Yes

1.025 D10 Sava GmbH & Co. KG Brunsbuttel, Germany

.215 R4 KMK Metals Tullamore, Co. Offaly Mixed Construction &

Demolition waste 17 09 04 Projects 51.8 No 34.48 R3 Greenstar




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(Tonnes /

Annum)

Hazardous (Yes/No)

Quantity / annum




GW Composting

20 01 08 Canteen 8.584 No 6.320 R3 Miltown Composting Facility Fethard Co. Tipperary


Mixed Municipal waste 20 03 01 Plant wide 33.56 No 30.45 D1 Greenstar



Bulky Municipal Waste 20 03 07 Plant wide 7.87


Acetone Distillate 07 05 04 Production 12.828

Yes 12.828 R1 Pfizer Little Island (On site)


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Table No. 2.5.2 : Waste Disposal/Contractor and Licence Permit Reference



Licence Permit Reference

Sava Brunsbuttel, D A51/V00605 Blending Facility 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

Rehab Recylicng Partnership Monahan Road , Cork 635

ATM

Afvalstofffen Terminal Moerdijk BV, Vlasweg 12, 4782 PW Moerdijk. 1538449

SCRL

430 Beech Road Western Industrial Estate, Nass Rd. Dublin 12 W0055-02

GreenStar Sarsfield Court Ind Estate, Glanmire, Co. Cork WCP-CK-0771-03

Miltown Composting Facility Fethard Co. Tipperary WP 019 02

Indaver Antwerp

Industriele Afvalverwerking Poldervlietweg B-2030 Antwerpen 3, BELGIUM

MLAVI/9800000485/MV/bd


28 28

Table 2.5.3 National Waste Database report sheet Industrial Sector NACE Code DG 24 Year 2011 Number of Employees : 240 Item Tonnes Total Quantity of Waste Produced in 2011 17712.1 Total Quantity of Waste Disposed on On-Site 12.8 Total Quantity of Waste Disposed of Off-Site 2643.1 Total quantity of waste Recovered On-Site 12.8 Total Quantity of Waste Recovered Off-Site 15056.2 Item Tonnes Total Quantity of Non-Hazardous Waste Produced in 2011 981.6 Total Quantity of Non-Hazardous Waste Disposed of On-Site 0

Total Quantity of Waste Non-Hazardous Disposed of Off-Site 30.5

Total quantity of Non-Hazardous waste Recovered On-Site 0 Total Quantity of Non-Hazardous Waste Recovered Off-Site 951.12

Item Tonnes Total Quantity of Hazardous Waste Produced in 2011 16730.5 Total Quantity of Hazardous Waste Disposed on On-Site 12.8 Total Quantity of Hazardous Waste Disposed of Off-Site 2612.6

Total quantity of Hazardous waste Recovered On-Site 12.8 Total Quantity of Hazardous Waste Recovered Off-Site 14117.9


29 29

2.6 Ambient Monitoring As part of IPPC licence P136-04, Pfizer Little Island were required to complete headspace monitoring on an annual basis for 2010 & 2011

Sampling point

Parameter 2010 2011

Headspace above the connection point with the sewer.

Methanol <0.932mg/m³ <0.09mg/m³ IPA <0.925mg/m³ <0.09mg/m³

MTBE <0.872mg/m³ <0.09mg/m³ Hexane <0.771mg/m³ <0.09mg/m³ Ethyl

Acetate <1.061mg/m³ <0.09mg/m³

Ethanol <0.929mg/m³ <0.09mg/m³

TA Luft Class III

<1.061mg/m³ <0.09mg/m³

THF <1.046mg/m³ <0.09mg/m³

Toluene <1.021mg/m³ <0.09mg/m³

TA Luft Class II

<1.046mg/m³ <0.09mg/m³

Table No.2.6.1 All results are in mg/m3


30 30

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 2011. 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 27 May 2011 Surface water report 25 Jan 2011 Final effluent report 25 Jan 2011 Surface water report 04 April 2011 Final effluent report 04 April 2011 Surface water report 15 Aug 2011 Final effluent report 15 Aug 2011 Surface water report 01 Nov 2011 Final effluent report 01 Nov 2011

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,.


- 31 -

EPA Inspections / Audits Table 2.7.1 . There was one site audit by the EPA in 2011 (30 Aug 2011)

Item No. Response 1 Bund and Bund Testing

A) Bund 507 – Caked solid observed in bund, some

IBC’s overhanging the bund edge, and drips into the bund from IBC’s of foam block were observed.

B) Bund testing – Control vessel not included in test programme and, some hydrostatic tests completed in 4 hours which is deemed too short.

A) Bund 507 I. Due to its location and the complex pipe work

matrix, which is located directly over the bund and in use 24hrs a day, seven days a week, an assessment is currently being prepared on cleaning this bund. Status: Complete

II. All IBC’s overhanging bunds were corrected at the time of the audit. Status : Complete

III. Stands have been installed to support the flexible chemical hoses and seals and to prevent drips at the IBC connection point. Status: Complete

B) Bund testing (i) A control vessel has been ordered and will be

used for all bund testing going forward. (ii) Bund testing will be a minimum of 24 hours,

with the exception of bunds where there are operational constraints due to availability of equipment and production demands. In the event that a bund test has to cease short of 24hours a visual check will be completed and recorded by a suitably qualified engineer. All bund testing for 2011 has been completed. Sop (A-EHS-23-3006) to be updated for bund testing in 2012. Status Complete


32 32

2 Composite Sampler

A) The temperature display unit on the lower

compartment of the composite sampler is not showing a reading, no manual readings are recorded.

A) A calibrated thermometer has been placed in the lower compartment, and temperature readings are recorded routinely. A formal system is in the process of being put in place, SOP A-EHS-23-1050 will be updated with this requirement. Status : Complete

3 AER

A) Little Island to verify the accreditation status of

each air and water analysis employed for compliance tests.

B) Hazardous waste 070504 incorrectly labelled as packaging’s on paper version of AER

C) Little Island to ensure that a five year time period is addressed when generating the EMP.

A) Contract laboratories have been contacted to update

Pfizer Little Island on the exact accreditation details for each compliance test, this feedback will be reviewed on site. Status : Complete

B) Corrected in paper AER, submission on PRTR correct. Status: Complete Where feasible projects and targets over a five year period will be incorporated into the EMP. Status: Complete

4 Emergency Response Procedure

A) Emergency response procedure does not include the

requirement for a facsimile to be forwarded to the EPA in the event of an incident.

B) The incident classification in the Emergency Response procedure has not been updated to reflect the five incident notification categories as required by the EPA.

A&B This information has been incorporated into the draft version of the Emergency Response Procedure. This draft procedure will be made effective once all training/other issues have been completed. In the


33 33

interim, key members of the External Agencies group which deal with routine communications to the Agency have been trained in the reporting requirements. Status: Complete

5 Stormwater Actuator valve

A) Check required to verify that the valve on the storm water

system has shut as indicated on the display panel. A) A routine visual check will be completed on the valve. It will be

placed on the sites planned preventative maintenance system and will be checked routinely by maintenance. This check will demonstrate that the valve is operating as indicated on the panel. Status : Complete.

6 Noise Report & Fire Water Integrity report

A) The licence registration no. on the noise report was

incorrect. B) There was no clear summary detailing the time period over

which the fire water retention facility was tested, or what the findings were.

A) The registration number on the noise report has been corrected. B) A summary of the report has been included in the final report Status : Complete


34 34

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. P0136-04 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.


- 35 -

Table 2.8.2 Monitored Noise Levels July 2011

Location Specific Noise Level dB(A) 1

Label Description Daytime Nighttime

Noise Sensitive Locations (subject to IPPC noise limits)

NSL1 St. Lappan’s Place <<59 <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, 28th /29th July 2011

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


36 36

Figure S.1. Measurement Locations and nighttime specific noise levels, Pfizer Ireland Pharmaceuticals Little Island, 28th /29th July 2011

NSL1 St. Lappan’s <41dB(A)

NSL2 North Eske <38dB(A)

NSL3 Factory Hill <37dB(A)

B1 51dB(A)

B2 52dB(A)

B3 50dB(A)

B4 58dB(A) B5

49dB(A)

N


37 37

Environmental Noise Survey Pfizer Ireland Pharmaceuticals, Little Island, Cork, July 2011

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.P0103-02 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 28th /29th July 2011.

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. Noise measurements and reporting were performed by Colin Doyle, and reviewed by Bridget Ginnity of ANV Technology Ltd..


38 38

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.


39 39

Figure 1. Noise measurement locations

NSL1 St. Lappan’s

NSL2 North Eske

NSL3 Factory Hill

B1 B2

B3 B4 B5

N


40 40

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


41 41

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 28th July 2011

Nighttime 28th /29th July 2011 Weather conditions

Daytime Dry, light northwesterly (Beaufort 2-3). Temperature 18°C, humidity 38%, overcast.

Nighttime Dry, light northwesterly breeze (Beaufort 2-3). Temperature 17°C, humidity 52%, overcast.

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 1010530 21-22/10/10

Svantek SLM 949 (Type 1) serial no. 8183

AV Calibration 1010514 18/10/10

Brüel & Kjær Calibrator 4231 serial no. 1859044

AV Calibration UKAS

05496 08/10/10

Table 3. Survey Conditions and instrumentation details.


42 42

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. The noise levels presented in Table 4 are the specific noise levels attributable to

noise emissions from Pfizer. The methodology for determining the specific noise component is presented in Table 2.

Where the specific noise was not clearly audible in lulls in traffic, it is estimated as being less than (<) the LA90 level (up to 5 dB lower than LA90).

In cases where the specific noise is not audible or detectible, it is estimated as being much less than (<<) the LA90 level (more than 5 dB lower than LA90).

The determination of the specific noise at each location is described here.

NSL1 St. Lappan’s Place During daytime there was no noise audible or detectible from the direction of Pfizer. The total ambient noise was due to clearly audible constant distant traffic noise only. The specific noise was therefore much less than the underlying steady LA90 level, and was estimated is to be <<50 dB(A). At nighttime the ambient noise was again due mainly to constant distant traffic noise and occasional local traffic. There was a barely audible industrial component of indeterminate origin. The specific noise attributable to Pfizer was therefore less than the underlying steady LA90 level, and was estimated to be <41 dB(A). NSL2 St. North Eske During daytime there was no noise audible or detectible from the direction of Pfizer. The total ambient noise was due to clearly audible constant distant traffic noise, and local traffic noise only. The specific noise was therefore much less than the underlying steady LA90 level, and was estimated to be <<46 dB(A). At nighttime the ambient noise was again due mainly to constant distant traffic noise and occasional local traffic. There was a barely audible industrial component of indeterminate origin. The specific noise attributable to Pfizer was therefore less than the underlying steady LA90 level, and was estimated to be <38 dB(A). NSL3 Factory Hill During daytime there was no noise audible or detectible from the direction of Pfizer. The total ambient noise was due to clearly audible constant distant traffic noise, and local traffic noise only. The specific noise was therefore much less than the underlying steady LA90 level, and was estimated to be <<46 dB(A).


43 43

At nighttime the ambient noise was again due mainly to constant distant traffic noise and occasional local traffic. There was a barely audible industrial component of indeterminate origin. The specific noise attributable to Pfizer was therefore less than the underlying steady LA90 level, and was estimated to be <37 dB(A). Boundaries B1 to B5 During daytime there was audible and detectible Pfizer plant noise at all boundaries. However there was significant interference from traffic or other noise sources, which increased the LAeq values. Consequently at boundaries B1 and B3, where there was a steady clearly audible industrial component, the Pfizer specific noise levels were estimated to equal the LA90 values. At boundaries B2, B4 and B5, where the Pfizer noise was barely audible, the specific noise was estimated to be less then the LA90 values. At nighttime there was clearly audible and detectible Pfizer plant noise at all boundaries, with occasional interference from traffic or other noise sources, which increased the LAeq values. At boundaries B2 , B3, and B5 where there was a steady clearly audible industrial component, the Pfizer specific noise levels were estimated to equal the LA90 values. At boundary B1, there was occasional interference from traffic noise. However the 10-second logged noise data was frequently of level 51 dB(A), and this was taken as the estimate of the Pfizer specific noise. At boundary B4 only Pfizer plant noise was audible, and the specific noise was taken to be the measured LAeq value.


44 44

Label Date Time2

Measured Noise Level dB(A) Comments

LAeq LA90 LA50 LA10 Spec-ific1

Daytime NSL1 28/7 13.30 52 50 52 54 <<50 Distant traffic, Pfizer not audible NSL2 28/7 15.20 57 46 49 57 <<46 Distant traffic, Pfizer not audible NSL3 28/7 14.30 56 46 48 52 <<46 Distant traffic, Pfizer not audible

B1 28/7 10.55 61 52 54 62 52 Site traffic, steady plant noise

B2 28/7 12.15 57 55 56 58 <55 Distant traffic, lower level plant noise

B3 28/7 11.55 68 57 60 63 57 Traffic, alarm test, plant noise

B4 28/7 11.35 68 59 64 70 <59 Site traffic, fork-lifts, plant noise barely audible

B5 28/7 11.15 62 56 58 61 <56 Constant traffic, fork-lifts, plant noise barely audible

Nighttime

NSL1 29/7 00.00 45 41 43 47 <41 Distant traffic, occasional local traffic, industrial noise barely audible



B1 28/7 22.15 52 50 51 52 51 Steady plant noise, distant traffic, helicopter

B2 28/7 23.10 53 52 53 54 52 Steady plant noise distant traffic

B3 28/7 22.45 53 50 53 55 50 Traffic, aircraft, very low level plant noise

B4 28/7 22.40 58 55 57 59 58 Plant noise

B5 28/7 22.20 53 49 53 56 49 Traffic, helicopter, low level plant noise

Table 5. Measured noise levels, Pfizer Little Island 28th /29th July 2011 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


45 45

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 in the range <<46 to <<50 at the noise sensitive locations.

Nighttime Limit 45 dB(A) The nighttime noise limit was complied with at all noise sensitive locations. The specific noise ranged from <37 dB(A) to <41 dB(A) at the noise sensitive locations. 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 2006 to 2011 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 previous years. At plant boundaries B2 and B3, there were reductions of 8 and 10 dB respectively compared with the 2010 survey. This was due to venting noise from the roof of operations 1 building during the 2010 survey, which was not present in the 2011 survey. At the other boundary positions, noise levels were similar to those measured in 2010. There is consequently no indication of any significant systematic change in overall noise emission from the site.


46 46

Location Dec 2006

May 2007

Aug 2008

May 2009

Aug 2010

Jul 2011 Type Label Description

Noise Sensitive Location

NSL1 St. Lappan’s Place <<52 <<45 <<48 42 <44 <41

NSL2 North Eske <<43 <<45 <<40 43 <44 <38

NSL3 Factory Hill <<47 <<43 <<42 42 <<40 <37

Boundary

B1 South East <55 <53 53 52 52 51

B2 South West <54 56 54 57 60 52

B3 North West 53 59 55 57 60 50

B4 North 59 58 57 60 56 58

B5 North East 54 <57 49 51 51 49 Table 6. Comparison of night-time specific noise levels, 2006 to 2011

Figure 2. Variation of specific noise levels at nearest houses to Pfizer, from 2006

to 2011

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

20

30

40

50

60

70

Dec 06 May 07 Aug 08 May 09 Aug 10 Jul 11

dB(A

) NSL1NSL2NSL3


47 47

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).


48 48

Appendix B - Night-time Noise Spectra Leq spectra at houses were subject to interference from traffic noise. L90 spectra better represent the presence of steady tonal components. There were no audible or detectible tones at the houses.

NSL1 St Lappan's 00.00

2025303540455055606570

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

NSL 2 North Eske 00.40

2025303540455055606570

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

NSL 3 Factory Hill 00.15

2025303540455055606570

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


49 49

B1 22.15

2025303540455055606570

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 23.10

2025303540455055606570

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 22.45

2025303540455055606570

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


50 50

B4 22.40

2025303540455055606570

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

B5 22.20

2025303540455055606570

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


51 51

Location Specific Noise Level dB(A) 1

Label Description Daytime Nighttime

Noise Sensitive Locations (subject to IPPC noise limits)

NSL1 St. Lappan’s Place <<50 <41

NSL2 North Eske <<46 <38

NSL3 Factory Hill <<46 <37

Plant boundaries (not subject to IPPC noise limits)

B1 South East corner of Pfizer site 52 51

B2 South West corner of Pfizer site <55 52

B3 North West corner of Pfizer site 57 50

B4 Northern Boundary <59 58

B5 North East corner of Pfizer site <56 49 Table 4. Mean Specific Noise Levels, Pfizer Ireland Pharmaceuticals, July 2011 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 nighttime noise spectra at the houses were determined mainly by distant traffic.


52 52

2.9 Resource Consumption

A summary of energy and water consumption for 2011 is presented in Table 2.9.1 with comparative figures for the previous two years.

Table 2.9.1 Energy & Water consumption

Year

Natural Gas

(kWh)

Electricity

(kWh)

Water (m3)

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

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

2011

16,450,902

1,562,736 596,1652

Note 1 : Details on the decrease of water usage in 2011 are covered in the EMP – Report on the Progress made and proposals being developed to minimise water demand and the volume of trade effluent. Report 2011. Note 2 : This value includes purchased water and water used from an onsite groundwater well installed in 2011, approx 13,663m3 of water was used from this source.


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2.10 Environmental Incidents & Complaints Table 2.10.1 Environmental Incidents in 2011 Date Incident Detail Corrective Action 07/Feb/2011 HCL Leak - A small localised cloud of HCL was

viewed on the west side of the OP1 Building.

Root Cause: Weeping of HCL from a temporary PVC flange. Preventative Action: New pump & connections put in place

21/March/2011 23/March/2011 27/March/2011 17 April/2011

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

Root Cause: Sensor error Preventative Action : Pump replaced

25/March /2011 Equipment malfunction pH probe on final effluent

Root cause – Equipment malfunction Preventative Action : New pH probe installed

18/April/2011 Caustic leak A piece of pipe work carrying caustic at height was damaged and cracked. Drops of caustic fell outside the bunded area and trace amounts entered the storm water system. All discharges from the site were stopped and diverted to the sites fire water retention pond.

Root cause – Impact on PVC pipework Preventative Action – Lines upgraded to PTFE where appropriate


54 54

Table 2.10.2 Environmental Complaints 2011 There were no complaints in 2011 Date Complaint Cause Corrective action N/A There were no environmental

complaints in 2011 N/A N/A


- 55 -

2.11 Energy Efficiency Audit Report Summary Table 2.11.1 Energy Efficiency Audit Report Summary Audit Type System Audited/Surveyed Audit/Survey by Technical Compressed Air Leakage

Survey&Repair O Neill Industrial

Technical Compressed Air efficiency/VSD feasibility analysis

Pfizer

Technical Thermographic Survey of Thermal Oxidiser

METS Ireland

Technical Water usage survey (ultrasonic clamp-on meter)

Pfizer

Technical Nitrogen Usage Survey Eirdata

Technical Annual Energy Aspects Review Pfizer /RPS

Internal Audit/Systems

Internal Audit (EnMS Review) Pfizer/RPS – Internal Audit

Technical Steam Trap Survey Pfizer/RPS – Internal Audit Internal Audit/Systems

HVAC Pfizer/RPS – Internal Audit


Chillers Pfizer/RPS – Internal Audit


Boilers Pfizer/RPS – Internal Audit


Compressed Air Pfizer/RPS – Internal Audit


PSA Plant Pfizer/RPS – Internal Audit

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

ANNUAL ENVIRONMENTAL REPORT 2011 ___________________________________________________________________________________

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3.0 Environmental Management Programme Report

A report on progress on the 2011 Environmental Management Programme is shown in

the Appendix 2.


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4.0 Pollution Release and Transfer Register Table 4.1 PRTR Table

The following substances are reported for 2011, through the EPA’s web-based reporting system. The following are the substances which were reported: No. Substance

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)


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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 2012. 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 2012 to December 2012 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 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)


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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.


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Proposals for AER period January to December 2012 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.

• Replace the current product A process with the product Z process.

• Implement the treatment of the two product Z aqueous brine streams in the WWTP

• Implement solvent recovery for raw material O1 and raw material A1 from the product Z process

• Maximise Product C yield and optimise opportunity for raw material V recovery

•

Q4 2012

Q4 2012

Q4 2012 Q4 2012

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

waste.

• Complete green belt project on haz. Packed waste

• Reduce haz waste generated in Op2

Q2 2012

Q2 2012

3 To maintain and calibrate key control and monitoring equipment.

• Complete QAL 2 on CEMS for Boiler No.1 • Configure QAL 3 for CEMS for Boiler No.1

Q2 2012 Q2 2012

4 To improve treatment / abatement systems to reduce emissions.

• Ensure efficient & effective transition in the WWTP for the change from product A to product Z waste streams

Q3/Q4 2012

5 Reduction in fugitive emissions • Reduce the no. Of TO bypasses • Reduce fugitive emissions using PAT

technology- On line sampling • Reduce fugitive emissions from product Z by

minimising IPTS’s

Ongoing Q4 2012 Q4 2013

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

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

• Maintain Emergency Management Team and Emergency Response Team training schedule

• Ensure integrity of bunded structures.

Ongoing Ongoing

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

• Install a chilled water loop in OP1 • Optimise cooling fan and VSD for chiller’. • Energy Aspects Review ’11 and update EMP • Carry out a steam trap survey on site • Site-wide Energy & Environmental Awareness

Campaign • Complete test burn No. 2 on boiler No.1 with

distillates • Complete an site leak detection survey.

Q3 2012 Q2 2012 Q1 2012

Q2 2012 Q2 2012

Q2 2012 Q2 2012

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

Licence, Corporate.

• Complete Site Management Review • Participation in laboratory proficiency scheme

Q2 2012 Q4 2012


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5.2 Environmental Management Programme proposal five year plan

The proposal for the Environmental Management Programme proposal for 2011 is

shown in the Appendix 3. The table below gives an overview of the sites five year

plan.


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Five Year Schedule for Objectives and Targets Objective / Target 2012 2013 2014 2015 2016

Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 MSR

(Management System Review)

Underground Pipeline Testing

Bund Testing Emergency

Training Product Z

Manufacture on plant

Commissioning of PAT for product Z

Proficiency Scheme

Perform Water Balance

Legal Register Updates

Test Burn No. 2 Initiate use of

solvent distillates from product A as fuel

Initiate use of solvent distillates from product Z as fuel

Reduce the site Carbon Foot print by 5%

Complete

To be Started


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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.


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Appendix

1. Groundwater Report 2. Environmental Management Programme Report for 2011 3. Environmental Management Programme Proposal for 2012 4. Bund Integrity Report 5. Electronic PRTR 6. Review of Residuals Management Plan 7. Review of Environmental Liabilities Risk Assessment. 8. Underground pipeline testing 9. Water demand and trade effluent generation minimisation

APPENDIX 1 Ground Water Summary Report for 2011


Pfizer Little Island IPPC Groundwater Monitoring Annual Groundwater Summary

Pfizer Ireland Pharmaceuticals\46402526 Pfizer Little Is GW 2011\DURP0002/EC/EC

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CONTENTS

Section Page No

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

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

2.1 Volatile Organic Compounds (VOCs) .............................................................................. 2 2.2 Other VOC Results........................................................................................................... 4 2.3 Other Groundwater Results ............................................................................................. 5

3. DISCUSSION OF THE REMEDIATION PROGRAM ...................................................... 6

4. POTENTIAL IMPACT ON SURROUNDING ENVIRONMENT........................................ 7

5. CONCLUSIONS AND RECOMMENDATIONS ............................................................... 8

6. LIMITATIONS ................................................................................................................ 10

7. COPYRIGHT.................................................................................................................. 10

FIGURES

TABLES



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1. INTRODUCTION

URS Ireland Limited (URS) is pleased to present the annual groundwater summary report

for 2011 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 3092565 and authorised by Pfizer

under their purchase order number N-2771577, dated 13 May 2011.

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 (biennially), as

opposed to biannually.

As such the Round 1 (May) 2011 and Round 2 (October) 2011 groundwater monitoring

programmes 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 2011 is presented in Table 1.

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

requirements:

• pH;

• Electrical conductivity;

• Temperature; and

• Dissolved oxygen.

Findings of the 2011 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 2011. 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

groundwater samples collected throughout 2011.

MTBE was detected in groundwater from most wells monitored but did not exceed the

Dutch Intervention Value (DIV) of 9.2 mg/L in any. MTBE concentrations in groundwater

from five wells did not exceed the EPA’s Draft Interim Guideline Value (IGV) of 0.03 mg/L

in both rounds conducted during 2011.

Table 2 presents the results for toluene and MTBE for key wells in 2011 and significant

contaminant trends for each well in 2011 are summarised below.

Well 201

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

October 2011.

During 2011, MTBE concentrations in groundwater from well 201 remained considerably

below the DIV for MTBE of 9.2 mg/L and the Draft IGV of 0.030 mg/L. The MTBE

concentration remained relatively static at 0.006 mg/L in May 2011 and 0.005 mg/L in

October 2011, 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 May and

October 2011.

The MTBE concentration in groundwater from well 202 was 0.004 mg/L in May 2011, it’s

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

0.011 mg/L in October 2011. 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 May and

October 2011.



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The MTBE concentration in groundwater from well 203 was 0.087mg/L in May 2011. The

MTBE concentration decreased to 0.017mg/L in October 2011, the lowest concentration

to date for this well. The MTBE concentration remained marginally above the Draft IGV

(0.030mg/L) in May 2011 and decreased below the Draft IGV in October 2011. Though

the MTBE concentration had been above the Draft IGV up until October 2011, it has been

below the DIV since September 2006.

Well 205A

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

October 2011.

MTBE was not detected above the MDL (0.001 mg/L) in groundwater from well 205A in

2011.

MTBE at well 205A has been below the DIV since December 2006 and was last detected

in groundwater in April 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 May and October 2011.

MTBE was not detected above the MDL (0.001 mg/L) in groundwater from well 207 in

2011.

Well 301

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

October 2011.

MTBE was recorded at concentrations of 0.069 mg/L and 0.035 mg/L in May and October

2011, respectively, in groundwater from well 301.

The MTBE results in 2011 are the first since March 2008 to exceed the Draft IGV (0.030

mg/L), however, MTBE concentrations decline declined from May to October 2011.

Well 302


October 2011.

The MTBE concentration in groundwater from well 302 increased slightly from

0.023 mg/L in May 2011 to 0.034 mg/L in October 2011, marginally exceeding the Draft

IGV (0.030 mg/L).

Well 304


October 2011.



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The MTBE concentration in groundwater from well 304 remained relatively static at

0.003 mg/L in May 2011 and 0.005 mg/L in October 2011. 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. The MTBE

concentrations have been below the draft IGV (0.030 mg/L) since April 2010.

Well 305

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

October 2011.

MTBE increased from below the reporting limit (0.001 mg/L) in May 2011 to 0.003 mg/L in

October 2011 in groundwater from well 305 (but 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 May and October 2011.

At well 404 MTBE concentrations have increased from below the method detection limit

in October 2010 to 0.123 mg/L in May 2011 and 0.157 mg/L in October 2011. The 2011

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. With the exception of October 2010, the MTBE concentration in well 404 has

remained above the draft IGV to October 2011.

Well 405

Well 405 was sampled in May and October 2011.

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

October 2011 from 0.005 mg/L in May 2011. MTBE concentrations from well 405 have

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

since April 2010.

2.2 Other VOC Results

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

detected in groundwater in 2011 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 two wells 404 and 405 in May 2011 and in

well 404 only in October 2011. Chloroform is not used on site.

Chloroform was detected at trace concentrations in well 405 (0.002 mg/L) in May 2011.

Chloroform was detected in groundwater from well 404 in May 2011 (0.212 mg/L) and in

October 2011 (0.045 mg/L). The May 2011 result for well 404 exceeded the Draft IGV

(0.012 mg/L) but was below the DIV (0.400 mg/L) and the October 2011 result was also



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below the GTV (0.075mg/L). Since a concentration of 0.414 mg/L was detected in

September 2009, chloroform concentrations have followed a general declining trend with

some fluctuations.

Chloroform concentrations in groundwater from up-gradient boundary well 207 were

below the MDL in May and October 2011. Chloroform had been detected in well 207 at

low but stable concentrations in previous monitoring rounds. It is likely that the source is

off-site and up-gradient of the Pfizer Little Island facility. However, the detections at well

404 and 405 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 May 2011.

Results for the May 2011 monitoring reported a detection of 1,1,1-trichloroethane in

groundwater from one well, 404 (0.026 mg/L). Similarly, the October 2011 monitoring

round reported a detection of 1,1,1 trichloroethane in groundwater from one well, 207

(0.004 mg/L). These concentrations do not exceed any defined threshold for 1,1,1-

trichloroethane. 1,1,1-Trichloroethane has historically been intermittently detected at

trace concentrations in groundwater from the site.

The majority of other VOCs were below the relevant MDLs in 2011 monitoring.

2.3 Other Groundwater Results

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

chemistry parameters were recorded during groundwater sampling at the Little Island API

facility in 2011.



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3. DISCUSSION OF THE REMEDIATION PROGRAMME

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 now redundant, and in most cases removed, 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, removal of this material by pumping

was slow, however the contamination appeared to be localised.

By the end of 2007, there was a general improvement in groundwater quality in the

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

systems. While the groundwater remediation system is no longer considered necessary

pumping continues from one well abstracting the limited quantity of groundwater present

for treatment in the site’s waste water treatment plant.

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 concentrations have declined by three orders of

magnitude since 2008. MTBE concentrations have increased slightly from below the

method detection limit in October 2010 to 0.123 mg/L in May 2011 and 0.157 mg/L in

October 2011. 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 subsurface 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 since

2008 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 m 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 2011 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.

The affect of pumping from the recently installed production well will likely reduce the

discharge of groundwater to Bury’s Bridge Basin from the site. However, it has not been

possible to measure the depth to groundwater in the production well and so this has not

been incorporated into groundwater contour maps for the site during biannual monitoring

rounds. Therefore, the affect of pumping on groundwater flow direction has not been fully

assessed.

In 2011, the highest concentration of VOCs detected was 0.212 mg/L chloroform in

groundwater from well 404 in May 2011, this declined to 0.045 mg/L in October 2011.

The detections of chloroform are localised to the former aeration basin area and it is

below reporting limits in groundwater from wells down-gradient of this. Therefore, the flux

to Bury’s Bridge Basin is considered negligible.



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5. CONCLUSIONS AND RECOMMENDATIONS

The main conclusions of the 2011 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.

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

infrastructural improvements.

• MTBE was detected in groundwater from well 404 in 2011; concentrations have

declined since November 2008. This suggests that the elevated concentrations seen

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 2011.

• Chloroform was detected in wells 404 and 405 in 2011. Chloroform concentrations

in well 404 have declined since September 2009. Chloroform was detected at a

trace concentration in well 405.

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

trace concentrations.

• Given the current much lower VOC concentrations (compared to historic results) and

improvements to the effluent systems in recent years, URS consider that the scope

of the future monitoring programme could be reduced (without compromising the

groundwater dataset). As such, URS recommend that the following wells be either

removed from the monitoring schedule or monitored on an annual basis in 2012:

o 201 (low VOC detections and wells 203 and 303 are located closer to Bury’s

Bridge basin);

o 202 (low VOC detections and well 203 is hydraulically down gradient);

o 205A (low VOC detections and wells 301 and 302 are located closer to Bury’s

bridge basin); and

o 405 (low VOC detections and well 303 is located hydraulically down gradient

and closer to Bury’s Bridge basin).



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• URS recommends that wells be monitored in 2012 in accordance with the following

schedule, subject to approval from the EPA:

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

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

compounds:

− 200-series wells - 203 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 well - 404.

o Monitored annually for volatile and semi-volatile organic compounds only.

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


o Monitored biennially for volatile and semi-volatile organic compounds only (as

directed by the EPA in 2010 and next due in Round 1 2012).


− 300-series well - 303



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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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CAR A PARTNERS

DN

UO

RG

RED

NU

NIA

MS

AG

PRODUCTION

402

403404405

102 101

103

103

202

SUMPD

201

303

304

305

301

302

203

206

205A

207

Production well

SUMPG

501

502

503

GROUNDWATER MONITORING WELL

MISSING GROUNDWATER

PRODUCTION WELL

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

FO’R

DATE

A

14.10.11

KeyCLIENT

PROJECT LOCATION

DRAWING TITLE

EO’H KF/COR

46402526AS SHOWN

North

PFIZER IRELAND PHARMACEUTICALS

LITTLE ISLAND, CORK

FIGURE 1 - SITE PLAN AND WELL

LOCATION MAP

ACORN BUSINESS CAMPUS, BLACKROCK, CORK

TEL +353 21 4536 136/7 FAX +353 21 4350 666



28 February 2012

Final

DURP0002

Tables

Table 1

Sampling Schedule for Pfizer Little Island 2011

LocationMonitoring

Well ID

Screen

Interval

(m)

May-11 Oct-11

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 N/A 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 N/A N/A

304 5.6-9.6 O O

305 2.9-6.9 O O

403^ 1.5-3.0 N/A 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 N/A 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

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

"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.

Notes

200-Series

Wells

300-Series

Wells

400-Series

Wells

500-Series

Wells

URS Ireland Limited \\swuk\jobs\Dublin-Jobs\Pfizer Ireland Pharmaceuticals\46402526 Pfizer Little Is GW 2011\Technical\2011 AER Summary\Table 1 Sampling Schedule 2011

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

2011

May-11 Oct-11 May-11 Oct-11

201 402

MTBE 9.200 0.006 0.005 MTBE 9.200 ns ns

Toluene 1.000 - - Toluene 1.000 ns ns

202 403

MTBE 9.200 0.004 0.011 MTBE 9.200 ns ns


203 404

MTBE 9.200 0.087 0.017 MTBE 9.200 0.123 0.157

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 ns MTBE 9.200 ns ns

Toluene 1.000 ns ns Toluene 1.000 ns ns

207 502

MTBE 9.200 - - MTBE 9.200 ns ns


301 503

MTBE 9.200 0.069 0.035 MTBE 9.200 ns ns


302

MTBE 9.200 0.023 0.034 Notes:

Toluene 1.000 - - ns Indicates well not sampled

303 BOLD Indicates result above DIV

MTBE 9.200 ns ns

Toluene 1.000 ns ns

304

MTBE 9.200 0.003 0.005

Toluene 1.000 - -

305

MTBE 9.200 - 0.003

Toluene 1.000 - -

- Indicates result below method reporting limit

Monitoring RoundWell / VOC DIV Well / VOC DIV

Monitoring Round

URS Ireland Limited \\swuk\jobs\Dublin-Jobs\Pfizer Ireland Pharmaceuticals\46402526 Pfizer Little Is GW 2011\Technical\2011 AER Summary\Table 2 Key Contaminant Trends 2011

APPENDIX 2 EMP – Environmental Management Programme Report for 2011


ENVIRONMENTAL MANAGEMENT PROGRAMME REPORT 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

The following programme was set out for 2011. 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, including status against target for 2011.

• Timescale

• Persons responsible


- 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. 136-04).

No.

Target

Plan/ Update

Responsibility

Timescale

1.1 Review solvent and water usage in the product Y process

Optimisation of product Y process: (1) Investigate the feasibility of reducing the raw material Y 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%. Status: 1: Investigation complete, reduction of raw material Y not suitable for processing. 2 Complete not successful as yield was too low. 3) Not completed in 2011, will not progressed due to transition to product Z in 2012.

(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). Status; Complete , Plate cleaning has been pushed out to a minimum of every 5 batches.

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

Q2 2011

1.3 Review solvent and water usage in the product W process

Identify and implement potential changes to reduce solvent and water usage in the product W process: (1) Investigate the feasibility of reducing the mill clean downs thereby reducing the volumes of raw material Z used and disposed of. Status : Not completed in 2011, due to potential impact on product quality.

TS (C Brack) Q4 2011


No.

Target

Plan/ Update

Responsibility

Timescale

1.4 Replace the current product A process with the product Z process

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

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

b. X 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%). Status: Full scale manufacture of product Z has been re-scheduled starting Oct 2012, due to supply demands.

PRODUCT 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. Status: Lab scale trail of Product z waste has been successful. Full scale manufacture of Product z has been re-scheduled starting Oct 2012, due to supply demands.


Q3/Q4 2011

1.6 Solvent recovery Implement solvent recovery for raw material O1 and raw material A1 from start up of full scale manufacture Status: Full scale manufacture of Product z has been re-scheduled starting Oct 2012, due to supply demands.


Q3/Q4 2011


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. Status: Complete. Waste Streams have been identified, SOP & training is complete, Process safety review complete, Occupational Hygiene review complete, production waste sop currently being updated.

M Maguire (EHS) Q2 2011


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. 136-04).

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. Status: This project will not proceed at this time.

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. Status : Complete, report on project issued.

E Callery Q2 2011


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. 136-04)

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. Status : Project complete

Projects Engineering (G Mc Namara)

Q 3 2011


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. 136-04).

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. Status: Ongoing, Q1=2 TO bypasses, Q2=4 TO bypasses Q3=7 TO bypasses Q4= 7 TO bypasses

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.

Status: project is in progress, however reductions in LEL’s will not be delivered as part of the project.

E Callery (EHS) & G McNamara (Engineering)

Q2 2012

5.3

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

1. Install the raman spectrometer for the PRODUCT Z process - Installed and fully qualified.

2. Qualify and commission the PAT (process analytical technology) currently in use for cyclopentyl for PRODUCT Z- Will be completed in conjunction with the PRODUCT Z start-up.

P Mc Gauley (T&I)

Q2 2012


5.0 Objective


5.4

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

Complete a green belt project on the PRODUCT Z IPTS to determine the feasibility of eliminating non value added testing. Status: Approximately 9 to 12 months after full scale manufacture starts will the project begin as a certain number of batch completions are required to obtain data.

B Furlong (QC) Q2 2013


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. 136-04).

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 Status : Ongoing

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. Status : Ongoing

EHS (M.Slattery) Continuous

6.3 Ensure adequate containment in the event of leakage or spillage

Construct a dedicated storage area raw materials G,E and G1 cost approved approx €75,000. Status : Complete

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 Status: Complete – Certification issued.

B. Minehane (Engineeing)

Q1 2011


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. 136-04).

No.

Target

Plan

Responsibility

Timescale

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

Complete a feasibility study on the installation of chilled water loop in OP1 in place of the current low temp distribution system. Status: Feasibility study complete Project proposal presented to SLT. No confirmation payback is dependent on future production volumes which are not confirmed. Second investigation undertaken into the installation of a chilled water loop for select OP1 users which would result in a 42% reduction in water usage.

M Madigan Q1 2011

7.2 Reduce Air Usage Investigate the installation of a VSD on the fixed speed compressors currently in operation. Status: Complete , variable speed drive compressor installed.

M Madigan Q2 2011

7.3 Reduce Energy Usage Reduce airflow FD-5701. Status: Complete

M Madigan Q2 2011

7.4 Reduce electricity Usage on site Install smart cool controllers on Site Chillers Status: Trial Carried out. Data indicated no improvement in performance, therefore this project was not progressed.

M Madigan Q2 2011


No.

Target

Plan

Responsibility

Timescale

7.5 Reduce energy usage on site Insulate cavity wall of external wall of Admin. Building. Status : Complete

M Madigan Q1 2011


Continued Process Optimisation: Survey individual users and jacket set points . Status: Ongoing: 2011 Water usage is significantly less than 2010.

M Madigan (Utilities) Continuous

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. Status: Monthly Energy and Water Report uploaded to Little Island home page. Bi-weekly Energy Team meetings.


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. Status: Energy Aspects updated and available on Intranet.

M Madigan (Utilities) Q 1 2011

7.9 Reduce Energy usage on site Carry out a compressed air site leak detection survey in 2011. Status: Complete: Steam Trap survey also complete, resulting in a saving of approx 100,000Kwh hrs/year.



No.

Target

Plan

Responsibility

Timescale

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. Status: Opportunities Table available on intranet. Environmental sustainability week rolled out in April 2011

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 A to be used 3) Complete configuration & set up to

enable Product z distillates to be used.

Status:1) Complete, 2) Suitable streams from product A to be identified. 3) Product z production now re-scheduled for May 2012

T&I Team, EHS, Engineering

1) Q2 2011 2) Q3 2011

3) Q4 2011


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 IPPC 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 Status : Complete April

M Slattery (EHS) Q2 2011

8.2 Maintain the laboratory test method standards

Participate in the Aquacheck proficiency scheme operated by LGC Standards. Status : Five samples approved in 2011

E Callery (EHS) Q4 2011

8.3 Optimise laboratory Standards A review was completed versus the standard and due to the transition to Product z a decision was made to not seek certification at this time. Status: Will not be progressed at this time



APPENDIX 3 EMP – Environmental Management Programme Proposals for 2012


ENVIRONMENTAL MANAGEMENT PROGRAMME PROPOSALS 2012 .

- 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 2012

2 Improved process control to reduce waste

Q4 2012

3 Maintenance and calibration of key control and monitoring equipment

Q2 2012

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

Q4 2012

5 Reduction in fugitive emissions

Q4 2013

6 Prevention of incidents with the potential for environmental consequences

Ongoing

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 2012 .

- 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 (IPPC No. 136-04).

No.

Target

Plan/ Update

Responsibility

Timescale

1.1 Replace the current product A process with the product Z process

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

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

b. X 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%).


Q4 2012

1.2 Reduction of off-site transport & treatment of waste

Implement treatment of 2 aqueous brine waste streams to the WWTP, on product Z as successfully trialled on a lab scale in 2011.


Q4 2012

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


Q4 2012

No.

Target

Plan/ Update

Responsibility

Timescale

1.4 Maximise product C yield and potential for raw material V recovery.

Implement change to recover all plate cleaning solutions from FD5701 (these are product rich), rather than going straight to waste. This No.1 optimises yield by ensuring that product is returned back to the process and 2. enhances the opportunity for recovery of the solvent waste V.

Product C team Q4 2012

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 and optimise hazardous packed waste options on site

Complete Green Belt project initiated in Sept 2012

M Slattery Q2 2012

2.2 Reduce the number of empty unclean drums leaving the site.

Implement transition to product Z, this will deliver a reduction of empty unclean drums of approx 8,000 per annum (~80%).

M Slattery Q4 2012

2.3 Reduce haz waste generated in OP2. Investigate the feasibility of using reusable (Launder able) dust suits in Op2 in place of the disposable ones currently in use.

L Crowley Q2 2012

2.4 Reduce packed waste hazardous waste and optimise segregation on site

Complete a review of batch records, walk each process and collate a clear defined list of all waste materials generated.

Indaver & M Slattery Q2 2012

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 IPPC Licence (Reg. No. 136-04).

No.

Target

Plan

Responsibility

Timescale

3.1 Qualify newly installed CEMS on site.

Complete QAL 2 testing on CEMS, on boiler V1 for use of distillates as an alternative fuel

C Collins Q2 2012

3.2 Configure QAL3 testing for CEMS for Boiler V1

Prepare QAL 3 documentation M Slattery Q2 2012

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. 136-04)

No.

Target

Plan

Responsibility

Timescale

4.1 Ensure smooth Transition from product A to product Z in waste water treatment.

Determine waste stream loading from product Z to WWTP and develop WWTP feed plan over the transition period from product A to product Z

E Callery Q3 2012

5.0 Objective


Rationale:

Specific requirements relating to the reduction of fugitive emissions are contained in Pfizer Little Island’s IPPC Licence (Reg. No. 136-04).

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 fugitive Emissions from the product Z Process- Minimise fugitive losses by completing on line testing where suitable.

Qualify and commission the PAT (process analytical technology) currently in use for product A for product Z

P Mc Gauley (T&I)

Q4 2012

5.3

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

Complete a green belt project on the product Z IPTS to determine the feasibility of eliminating non value added testing. Approximately 9 to 12 months after full scale manufacture starts will the project begin as a certain number of batch completions are required to obtain data.

B Furlong (QC) Q4 2013

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. 136-04).

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 Status : Ongoing

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. Status : Ongoing

EHS (M.Slattery) Continuous

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. 136-04).

No.

Target

Plan

Responsibility

Timescale


Complete installation of chilled water loop in OP1 in place of the current low temp distribution system. CPA approved for works of approx 490,000$, and an expected reduction of 40% in water usage.

M Madigan Q3 2012

7.2 Reduce electricity Usage on site Optimise cooling fan and VSD for chiller 2402.

M Madigan Q2 2012


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


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


No.

Target

Plan

Responsibility

Timescale

7.5 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.

M Madigan (Utilities) Q 2 2012

7.6 Reduce Energy usage on site Carry out a compressed air site leak detection survey in 2012.


7.7 Reduce Energy usage on site Carry out a steam trap survey in 2012 M Madigan (Utilities Q2 2012 7.8 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 from for collecting suggestions on energy conservation, waste & water reduction site.

M Slattery (EHS) & M Madigan (utilities)

Q4 2012

7.9 Reduce Energy Usage on Site Following the approval by the Agency of Test burn No.1 for the use of alternative fuels in the sites gas boiler,

1) Complete boiler test burn No.2 2) Complete configuration to enable

distillates from product A & ATC to be used

3) Identify and investigate the suitability of distillate streams from off site sources as a fuel in the boiler.

T&I Team, EHS, Engineering

1) Q1 2012 2) Q3 2012

3) Q4 2012

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 IPPC 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

M Slattery (EHS) Q2 2012

8.2 Maintain the laboratory test method standards

Participate in the Aquacheck proficiency scheme operated by LGC Standards.


APPENDIX 4 EMP – Bund Integrity 2011


Bund Test Data 2011 Bund Number Bund Description Bund Location Year of

Test Status

106 8 x 50 m3 Tanks (TK241, etc.) Tank Farm (Western side) 2011 Passed

108 Pump Bund (MTBE)(PU269,282,104) Tank Farm (South Eastern side) 2011 Passed

109 Pump Bund (IPA/MeOH)(PU227, etc.) Tank Farm (Southern side) 2011 Passed

115 RC 623/624 Tank Farm (Western side) 2011 Passed

121 West side Foam Tank Bund Western Aspect of Tank Farm 2011 Passed

303 Tk 623/624 (Old MeOH /H2O) Southern aspect of OP1 2011 Passed

307 Group 9 Bund (TK 901, 902, 903) Northern Aspect of OP1 2011 Passed

308 SC 101/201A N Aspect of OP1 2011 Passed

312 Nickel Ion Exchange Passage between Gp 9 & Gp 5 of OP1 2011 Passed

314 Ion exchange regeneration skid North of Grp 9 & Grp 5 of Prod. Building OP1 2011 Passed

402 HCl IBC’s Western Aspect of DIW Plant 2011 Passed

403 NaOH IBC’s Western Aspect of DIW Plant 2011 Passed

Bund Number Bund Description Bund Location Year of

Test Status

405 Diesel Tank WWTP Building North 2011 Passed

406 New Methanol Tank SW of New Utilities Building 2011 Passed

407 Methanol pump W Aspect of New Utilities Building 2011 Passed

408 Fuel oil pump bund N aspect of New Utilities Building 2011 Passed

412 Utilities Chemical Dosing Inside boiler house 2011 Passed

417 Warehouse Drumstore Cabinet East of New Drum-store Building 2011 Passed

418 QC/CS Chemical Store South Eastern Aspect of Warehouse 2011 Passed

421 Waste Oil Tank East of Old Weak Stream Tank 2011 Passed

430 Waste Oil Tank North West of Maintenance Building 2011 Passed

517 Weak Stream tank New Weak Stream tank 2011 Passed

518 OP3 Cooling Tower West of OP 3 2011 Passed

520 IBC Storage Bund South OP 1 2011 Passed

525 Boiler -Distillate Feed tank North of Utilities

Installed -2011 Passed

526 Acetic Acid IBC Bund West of Grp 5


Bund Number Bund Description Bund Location Year of

Test Status

527 Nickel IBC Storage Bund West of Grp 5


528 Caustic IBC Storage Bund West of Grp 5


APPENDIX 5 PRTR 2011


APPENDIX 6 Review of Decomissioning Management Plan


DMP Update 2012

Decommissioning Management Plan

21st March 2012 Final

Issue No 1 46402108

DMP Update 2012


Pfizer Ireland Pharmaceuticals /46402108/DMP AnnInfo 2011 21 March 2012

Final

Project Title: DMP Update 2012

Report Title: Decommissioning Management Plan

Project No: 46402108

Status: Final

Client Contact Name: Marian Slattery

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

Document Production / Approval Record

Issue No: 1

Name Signature Date Position

Prepared by

Michelle Purcell

21st March 2012

Environmental Scientist

Checked by

Klara Kovacic

21st March 2012

Project Manager

Approved by

Danny Ward

21st March 2012 Project Director

Document Revision Record

Issue No Date Details of Revisions

1 21st March 2012 Final

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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 DMP update ...................................................................... 3 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 ........................................................................................... 9

3. SCREENING AND OPERATIONAL RISK ASSESSMENT .......................................... 13

3.1 General ........................................................................................................................... 13 3.2 Complexity ...................................................................................................................... 13

4. SCOPE OF DMP ............................................................................................................ 15

4.1 General ........................................................................................................................... 15 4.2 Exclusions From the DMP .............................................................................................. 16

5. CRITERIA FOR SUCCESSFUL DECOMMISSIONING ................................................ 17

6. MANAGEMENT OF THE DMP ...................................................................................... 18

7. PROGRAM TO ACHIEVE STATED CRITERIA ............................................................ 19

7.1 Closure Plan ................................................................................................................... 19 7.2 Restoration and Aftercare Management Plan – Management of Potential Long

Term Residual Soil and Groundwater Contamination.................................................... 38 7.3 DMP Completion Timeframe .......................................................................................... 41 7.4 DMP Test Programme ................................................................................................... 42 7.5 Final Validation ............................................................................................................... 42

8. SUMMARY OF COSTS ASSOCIATED WITH THE DMP ............................................. 44

9. UNDERWRITING THE DMP – FINANCIAL PROVISIONS........................................... 45

10. REVIEW OF THE DMP .................................................................................................. 45

11. LIMITATIONS ................................................................................................................ 46

12. COPYRIGHT .................................................................................................................. 46

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 (IPPC) (Register Number P0136-01 by the Environmental Protection Agency (EPA)) on the 20th December 1996 for the manufacture of pesticides, pharmaceutical or veterinary products and their intermediates. This licence was reviewed three times and the current IPPC licence (Reg. No. P0136-04) was issued by the Environmental Protection Agency (EPA) on the 7th 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.’

On the 25th January 2011 the EPA approved the transfer of IPPC Licence Reg. No. P0136-04 from Pfizer Overseas Pharmaceuticals and C.P. Pharmaceuticals International C.V. (a limited partnership represented by and acting through Pfizer Manufacturing LLC and Pfizer Production LLC) to Pfizer Ireland Pharmaceuticals.

The EPA granted a Technical Amendment A of IPPC Licence Reg. No. P0136-04 on 31st March 2011 which covered amendments to Schedule B.3 Emissions to Sewer, Schedule C3.2 Monitoring of Emissions to Sewer, Condition 8.11.1 and Condition 3.8. A further Technical Amendment (B) was granted by the EPA on 16th December 2011 which amended Conditions 4 and 8.11.1 and rectified errors in licence conditions.

Environmental management of the site is regulated by the conditions outlined in PIP’s IPPC Reg. No. P0136-04 and subsequent amendments.

Condition 10 of the IPPC licence 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.

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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.

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 programme 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 DMP.

The original DMP (referred to as RMP in previous revisions) was prepared in March 2008 and subsequently updated in March 2009, 2010 and 2011.

This report presents the 2012 annual review of the original DMP, as required in Condition 10.2.2 of the site’s IPPC licence.

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1.2 Key Changes since previous DMP update

A revised IPPC licence (Reg. No. P0136-04) was issued by the EPA on the 7th January 2011 to account for the upgrade of Boiler A to burn organic distillate as a fuel. The following site modifications have been incorporated into the design of the co-incinerator: 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. The co-incinerator has not been operational since the issue of the revised licence. PIP anticipates that it will be operational in Quarter 2/Quarter 3 2012.

IPPC Licence Reg. No. P0136-04 was updated to include the following associated activity:

‘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.’

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.

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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 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 and have a future use following vacation of the site by PIP. Therefore costs for demolition works are not included in this DMP. 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 Annual Environmental Report (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.

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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:

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, Appendix A. In the area surrounding the facility, the land is used as follows:

East: The site formerly occupied by Showerlux (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 1km of the facility there is a population of approximately 500 people. There is a school approximately 1km to the east of the facility. There is one designated Special Area of Conservation (SAC), (Great Island Channel) and one Special Protection Area (SPA) (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 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:

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• Site Waste Water Treatment: new plant (1988); sludge dewatering (1994); additional oxygen input (1996); weak stream equalisation (1997); separation of 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).

• Upgrade of Pilot Plant Building: refurbishment for small scale production (2002);

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

• 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).

• Strong Stream System: this system was brought above ground (2006);

• Weak Stream System: this system was replaced (2008);

• 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. This lab became operational in 2011.

• Four new bunds were installed in 2010, comprising:

o Caustic Storage Tank (TK521);

o Nickel ASP Storage tank (TK522);

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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:

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), reduce 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.

• In 2011, PIP installed two new tanks, a Bulk Ethanlomine tank (25,000m3) and a Bulk Brine Tank (30,000m3). In addition, PIP also installed four new bunds – Bunds 526 – 528. Bunds 525, 526 and 527 are located West of Grp 5 (part of OP1) whilst bund 525 is located North of Utilities. These bunds are used for storage of acetic acid, caustic and nickel drums. PIP has added these new bunds to the onsite bund register.

• In 2011 one aeration basin associated with the onsite WWTP was decommissioned. Prior to implementation, a study conducted on site demonstrated that the remaining 3 aeration basins provided sufficient capacity. This project was carried out in order to reduce energy consumption on site.

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• In 2011 a heating system was installed in the Warehouse and a Steam Heating Battery and control system on the Air Handling Unit (AHU) serving the OP1 Production area.

• New environmental protection measures, other than those listed above, implemented during 2011, comprise:

o A lab scale trial of the treatment of brine waste in the WWTP was completed;

o Solid waste compactor installed on site resulting in a reduction of the volume of liners and Personal Protective Equipment (PPE) waste sent off site;

o A tracking system to track WWTP parameters was installed;

o Diversion lines from the weak stream tank in Bund 517 to the Firewater Retention Pond and Old Weak Stream Tank were installed. This allows any material which enters the drainage system to be diverted to these new containment areas and away from the WWTP;

o The firewater retention pond was tested for integrity and certification was issued;

o A feasibility study on the reduction of once through cooling water was completed;

o A Variable Speed Drive (VSD) compressor was installed to replace the fixed Air Compressor reducing air usage;

o A number of measures in relation to the reduction of energy usage were implemented including the insulation of the external wall of the Administration Building, the completion of a compressed air leak detection survey and the roll out of an Environmental Sustainability Week;

o The Green Belt Project on stormwater diversions was undertaken in order to eliminate trace quantities of methanol entering the cooling water system; and

o The Yellow Belt Project on methyl tertbutyl ether (MTBE) commenced with the aim to investigate and identify the causes of elevated MTBE in final effluent. This project resulted in a marked improvement in the performance of the WWTP due to the implementation of corrective actions.

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:

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• Intermediates from other production facilities;

• Organic and inorganic reactants;

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

• 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 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 (WWTP);

• Multi-story dryer building;

• A drum storage building;

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• 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 Electricity Supply Board (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 IPPC Licence Reg. No. P0136-03 on the 15th October 2008. This TA allowed for the generation of chlorine as a by-product in a new process, which 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 PIP to use distillates (solvents) arising as residues from the site production processes as fuel in the sites steam raising boiler.

PIP received a Technical Amendment A to IPPC Licence Reg. No. P0136-04 on the 31st March 2011. This amendment accommodated changes to licence conditions including the removal of the requirement to monitor Total Organic Carbon (TOC) on emissions to sewer, the allowance to accept waste at the site for co-incineration and the requirement to have a Class 1 Bypass Separator installed as opposed to a Full Retention Separator.

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A further Technical Amendment was granted in 2011 which corrected clerical errors present in IPPC Licence Reg. No. P0136-04.

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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 Licence 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 produces <2000 tonnes per annum and therefore it is assigned Complexity Band G4

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 2012, PIP plan to use a co-incinerator to incinerate 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; and

• Non hazardous wastes.

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

• Ductwork contaminated with Active Pharmaceutical Ingredients (API’s); and

• Equipment contaminated with API’s.

Any waste arising during decommissioning will be managed in accordance with Condition 8 of IPPC Licence 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; and

• 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.

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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 Polychlorinated Biphenyls/Polychlorinated Terphenyls (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; and

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.

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Each stage is considered under the following headings:

• 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 (OP2);

• Centrifuge building (OP1);

• High Containment Pilot plant (OP3); and

• Laboratories.

With regard to programmes for production decontamination, it is considered that many such programmes are currently in place due to the strict cleaning regimes and regulatory and legislative requirements in force. These programmes 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.

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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.

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; and

• 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 SOP’s, to suitably compliant packaging 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 keg plastic drums and Flexible Intermediate Bulk Containers (FIBC’s), from production buildings and the Pilot Plant to solid waste storage area;

• Transfer of pallets to solid waste storage area;

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• 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;

• Removal of general skip waste (e.g., packaging not product contaminated) to the solid waste storage area; and

• 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 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 aqueous liquid streams would be discharged directly to the process effluent drainage network, transferred to the on-site WWTP and the treated effluent discharged to the sewer under the terms of the IPPC Licence.

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;

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• High calorific value (CV) organic distillates used on-site in Boiler A to generate steam for the site; and

• 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; and

• 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; and

• Nitrogen: Nitrogen lines may be isolated by closing the main nitrogen distribution valves.

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Stage 1 - Task 8: Isolate from low temperature coolant loop, ventilation, scrubbers and VOC abatement units

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; and

• 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; and

• 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

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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.

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 2011) it can be estimated that approximately 674 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 135 tonnes of raw materials will still be on site and will require disposal.

It is assumed that the approximate 135 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.

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Plant Status at Completion of Stage 2

The warehouse, final product store and other raw materials storage areas will be clear of raw materials.


The residuals set out above should all be removed over a 4 week period, allowing for documentation (including inventory lists) and arranging shipment.


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; and

• 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 2011.

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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.

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.


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.


The predicted costs associated with this stage are summarised in Tables 7.1.4.1 and 7.1.4.2.

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Table 7.1.4.1: Hazardous Waste Inventory.

Waste Type Amount (tonnes) Estimated Cost (€)

Raw Materials Note 1 135 25,515

Aqueous Mother Liquors Note 2 566 106,974

Other organic solvents Note 2 2,614 494,046

Drums (empty) Note 2 35.7 21,277

Solids/packaging Note 2 27.5 16,390

Lab smalls Note 2 0.04 23.8

Waste fuel/diesel/lube oils Note 2 0.27 51

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 and contaminated catalyst Note 2 12.5 7,450

Batteries (Pb, Ni and Alkaline) Note 2 0.006 3.6

Fluorescent tubes & other mercury containing waste Note 2

0.12 71.5

Gas cylinders Note 2 0.008 4.7

Other Hazardous Wastes (including organic/inorganic substances/medical waste)

Note 2 3.26 1,943

Acid/Base Waste Note 2 2.37 448

TOTAL 3,444 €702,158 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 2011. Note 3 –Nominal figure. 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.

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Table 7.1.4.2: Non Hazardous Waste Inventory

Waste Type Amount (tonnes) Estimated Cost (€)

General waste Note 1 10 3,000

Excess Sludge Note 1 151 45,300

Timber Pallets Note 1 7 2,100

Fibre Kegs/Cardboard/Paper Note 1 2.1 630

Glass Note 1 0.15 45

Construction and Demolition Note 1 14.3 4,290

Metals Note 1 4.7 1,410

Mixed/Plastic Packaging Note 1 2.6 780

TOTAL 192 €57,555 Note 1 - This figure is based on 20% of each waste stream produced in 2011.

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 36 bulk storage tanks, ranging in capacity from 15 to 60 m3. These storage tanks contain virgin solvents and liquid wastes containing solvents. There are 83 bunds and sumps on the site. Bunds and sumps are tested every 3 years in accordance with Condition 6.10 of IPPC licence Reg. No. P0136-04. Costs for removal/filling of bunds/tanks/sumps are not included as these are assumed to remain in place for future use.

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.

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.

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.

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The pricing provided by a cleaning contractor in Dublin 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 36 = € 18,000 for cleaning of tanks;

• € 350 x 83 = € 29,050 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 € 54,550.

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;

• Mechanical parts;

• Protective clothing; and

• Miscellaneous.

These materials will be removed and disposed of 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);

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• 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; and

• 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 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

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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 nominal figure of 37 tonnes of waste from the TO support bed is included in total 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.

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. Estimated tonnages and costs are included in Table 7.1.4.1. These costs are included as part of Stage 3 in Table 9.1.

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.

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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

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.

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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 approximately 10 tonnes of WEEE generated 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.


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 €299,484.

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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

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 104 tonnes of de-watered sludge will be disposed as hazardous waste.


WWTP decommissioned.


The WWTP would be the final facility to be decommissioned and it is estimated that this would take approximately 3 weeks to complete.


The principle costs in decommissioning of the WWTP are:

Cleaning and flushing of WWTP. Estimate: €20,000

Dewatered sludge: Total clarifier and aeration basin volume (3 aeration basins currently present on site, one decommissioned in 2011) is 1,646 m3 operating at a solids concentration of approximately 9,500mg/l. This equates to 15.6 tonnes dry solids giving

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104 tonnes at 15% solids. Therefore, approximate cost for disposing sludge as a non-hazardous waste (at €300 per tonne) is estimated at €31,200.

This gives a total budget cost estimate for the WWTP decommissioning of €51,200.


The WWTP 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 basins, and dewatering of activated sludge then the WWTP will take approximately 4 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.

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.

Plant Status at End of Stage 8

All hazardous residual materials removed off-site.

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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: Security Arrangements

Prior to vacation from the site Pfizer will arrange to secure all on site buildings. This will include sealing doors and windows and removing access to roof areas. An onsite security presence will also be arranged for the site. Three years on site security is provided for in this DMP at a cost of €405,000.

Plant Status at End of Stage 9

Site is made secure and provided with an onsite security presence.


The overall cost estimate for on site security is €405,000.


The time estimate for securing on site buildings prior to vacation of the site is 1 week.

7.1.11 Stage 10: 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 EPA 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 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 groundwater, 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. 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 WWTP have declined to below the Dutch

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Indicative level for serious contamination (9.2 mg/l). In the October 2010 monitoring round all groundwater MTBE concentrations bar one (well 203) were below the EPA’s draft Interim Guideline Value (IGV) of 0.03 mg/l. In 2011 monitoring events (May and October), MTBE was detected in groundwater from most wells, with results for wells 203, 301, 302 and 404 recording exceedances of the IGV.

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. MTBE concentrations in 2011 increased compared to the October 2010 result, however they are still among the lowest on record for well 404.

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 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 wells 403 and 501 could be formally removed from the monitoring schedule and requested that wells 206 and 303 be monitored every two years (biennially) as opposed to biannually.

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 2011 data for MTBE in groundwater 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.

Toluene was also detected historically, but was below reporting limits in all groundwater samples from 2011. Chloroform was the VOC detected with the highest concentration in 2011; however, it was localised to the former aeration basin area and was below reporting limits across the rest of the site. The flux to Bury's Bridge Basin of both toluene and chloroform is considered negligible.

7.2.2 Characterisation of Potential Source areas of Chemical Release

Following plant closure, in order 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

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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 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 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, 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.

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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 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.

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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.

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

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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;

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 8.1 and includes all costs identified during the analysis of the Short Term and Long Term Programs.

Table 8.1 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

€702,158

€57,555

STP. 4 Cleaning of Tanks and Bunds €54,550

STP. 5 Non-process related wastes €1,000

STP. 6 Decommissioning of Site Services, including Laboratories

€299,484

STP. 7 Decommissioning of the WWTP €51,200

STP. 8 Removal of Residual Hazardous Materials €12,000

STP. 9 Site Security €405,000

Final Validation €12,000

SUB TOTAL STP (approximate) €1,874,947

LTP.1 Investigation for Potential Contamination Sources € 85,000

LTP.2 Source Area Soil Treatment € 322,000

LTP.3 Monitoring of Groundwater Contamination € 45,000

SUB TOTAL LTP (approximate) €452,000

DMP TOTAL (approximate) €2,326,947

In conclusion, in the unlikely event of site closure, it has been estimated that approximately €2.3 million would be required to bring the site to an environmentally safe condition.

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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.

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; and

• 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 AER.

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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

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

FINAL

Job No: REV

24.02.12

AAS SHOWN

PFIZER IRELAND PHARMACEUTICALS

FIGURE 1 - SITE LOCATION

MP PH / DUB

PFIZER LITTLE ISLAND DMP UPDATE 2012WALLINGSTOWN, LITTLE ISLAND,

Co. CORK

SML

46402108

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Final

Appendix B - Gantt Chart

DMP Update 2012 Decommissioning Management Plan


Final

Gantt Chart

ID Stage W1 W2 W3 W4 W5 W6 W7 W8 W9 W 10 W11 W12 W13 W14

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/non-hazardous wastes

6 Decommissioning Site Services

7 Decommissioning of the Wastewater Treatment Plant

8 Removal of Residual Hazardous Materials

9 Site Security

10 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


URS Ireland Limited Iveagh Court, 4th Floor, 6-8 Harcourt Road, Dublin 2 Tel: +353 (0) 1 415 5100 Fax: +353 (0) 1 415 5101 www.ursglobal.com URS Ireland Limited Place of registration: Ireland Registered number: 107912

Registered office: Iveagh Court, Bock E, 4th Floor, 6-8 Harcourt Road, Dublin 2, Ireland

Pfizer Ireland Pharmaceuticals\46402006 Pfizer Anninfo RMP ELRA 2010\DULT0002/JAG/JAG

Our Ref: 46402108 21

st March 2012

Marian Slattery Pfizer Ireland Pharmaceuticals Wallingstown Little Island Cork For the attention of Ms Marian Slattery Re: Annual Statement of Measures covering Environmental Liabilities updated March 2012,

Licence Register Number P0136-04 Dear Marian, This Memo presents a summary of the updates made to the previous ELRA update (completed in 2011) and addresses the IPPC licence condition 12.3.1, which requests: ‘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.’ URS updated the ELRA in 2011 primarily due to the changes on site as a result of the planned change in use of Boiler A which Pfizer plan to operate as a co-incinerator during 2012. The current high level of prevention and protection that is embedded in the site operation continues and has been adopted in the modifications required to operate Boiler A as a co-incinerator. In addition, ongoing site improvement is realised through the implementation of the Environment Management Programme (EMP). The measures to be taken by PIP are outlined in Table 1 below. Measures are in place within PIP Little Island to ensure compliance with licence conditions and that the facility does not significantly impact on the surrounding environment. Table 1: Statement of Measures

Risk I.D. Risk Score Mitigation Measures

to be taken

Outcome Action Date for Completion

Owner / contact person

1 to 19 ≤12 (Green

zone) Note 1 Note 2 Note 3 Ongoing

Environmental Adviser

Note: 1 The risk assessment identified no red or yellow zone risk, which require immediate action. 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.

2 No change to any risks identified. 3 All risks were classified as the green zone risks and require ongoing monitoring to ensure risks remain in

green zone, i.e. ≤12.

Page 2 of 2

URS Ireland Limited Iveagh Court, 4th Floor, 6-8 Harcourt Road, Dublin 2 Tel: +353 (0) 1 415 5100 Fax: +353 (0) 1 415 5101 www.ursglobal.com URS Ireland Limited Place of registration: Ireland Registered number: 107912

Registered office: Iveagh Court, Bock E, 4th Floor, 6-8 Harcourt Road, Dublin 2, Ireland

Pfizer Ireland Pharmaceuticals\46402006 Pfizer Anninfo RMP ELRA 2010\DULT0002/JAG/JAG

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 Pfizer Ireland Pharmaceuticals site reviews its insurance and financial arrangements on a regular basis for its ongoing and continued adequacy. No changes to the current insurance arrangement have been made. As part of a company restructuring exercise, resulting in a change in the name of the legal owner of the Wallingstown site, a transfer of Licence P0136-04 was formally completed and notified to Pfizer Ireland Pharmaceuticals in January 2011. As part of the transfer, a Financial Provision was agreed with the Agency in January 2011. Under the Financial Provision, Pfizer Inc. specifically guarantees to underwrite the financial commitments or liabilities identified in the site Decommissioning Management Plan (DMP) and the ELRA should Pfizer Ireland Pharmaceuticals fail to do so. A copy of the Financial Provision is provided as an attachment to this letter. A separate revision of the DMP has been undertaken as part of the AER submission covering the calendar year 2011. The Financial Provision attached to this memorandum also includes for the revised DMP. Yours faithfully URS Ireland Ltd

John Grumley Project Manager Attached: Pfizer, Financial Provision Licence Register No. P0136-04.

APPENDIX 8 Underground Pipeline Testing Report - 2011

Pfizer Ireland Pharmaceuticals, Little Island

Summary A pipeline integrity survey was initiated on all underground weak stream, foul sewer and final effluent lines and associated tanks, at Pfizer Ireland Pharmaceuticals, Little Island in 2010 and 2011. A total of one hundred and forty four pipelines, manholes and sumps have been tested. Four remain outstanding as they require a production shutdown window to complete which has not occurred since the survey commenced but is scheduled for August 2012. Of the one hundred and forty four pipelines, manholes and sumps tested to date the integrity of thirteen weak stream lines were found to be compromised. All foul and final effluent lines and associated sumps tested to date passed the integrity test. The impaired weak stream pipes were inspected to detect the fault and eight 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 completed 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 3.16 Final Effluent Sewer System 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 which will require a production shutdown window, scheduled for August 2012, to be completed.

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 Gully WS26 Passed 48 Yard Drainage Channel WS26 Passed 49 WS26A WS26 Passed 50 WS26C WS26 Passed 51 Pyrophoric Building &

WS26B WS26 Passed

52 ATC Skid Channel ATC Skid Manhole Passed 53 Tank Farm ATC manhole Passed 54 Bund 309 Gully Drainage Channel Passed 55 ATC manhole WS26C 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).

3.8 P1 Building Weak Stream System Table of Results Item No.

From To Result

56 Gullies WS27B Passed 57 Gullies WS27C Passed 58 Contractors Cpd Line WS27C Passed 59 WS27C WS27B Passed 60 Drainage Channel WS28A Passed 61 Drainage Channel WS28C Passed 62 Floor Gullies WS28 Passed 63 External Gully (North) WS28 Passed 64 External Gully (South) WS28 Passed 65 Drainage Channel WS28A Passed 66 RE503/4 WS28B Passed 67 RE502 WS28B Passed 68 Drainage Channel WS28C Passed 69 Gp 8 Drainage Channel Sump A Passed 70 Gp 3 & 4 & Drier Channel Sump C Passed 71 Gp 1,6 & 7 Drainage Channel Sump D Passed 72 Gullies Sump D Passed 73 Gp 8 Drainage Channel Sump E Failed 74 Gp 2 Floor Gullies Sump F Passed 75 Gp 10 Floor Gullies (A) Sump F Passed 76 Gp 10 Floor Gully (B) Sump F Passed 77 Gp 10 Drainage Channel Sump F Passed 78 Sump D Sump E Failed 79 Sump E WS18 Passed 80 Sump F WS19 Passed 81 Bund 309 Drainage Channel Failed 82 IBC Storage Bund WS26 Passed 83 Sump C & Gullies WS21 To be tested 84 WS26 WS21 To be tested 85 WS18 WS21 To be tested 86 WS27B Manhole Passed 87 WS27C Manhole Passed Summary of Results The underground weak stream pipelines and associated sumps from the P1 Building passed the hydrostatic test accept the lines from Gp 8 Drainage Channel to Sump E, Sump D to Sump E and Bund 309 to Drainage Channel (see section 4.0 for details on this and subsequent repairs). The three lines still to be tested are continuous live lines which

will be tested when production ceases during the site shutdown scheduled for August 2012. 3.9 Old WWTP Area Weak Stream System Table of Results Item No.

From To Result

88 WS39 WS22B Failed 89 New Weak Stream Tank Old Weak Stream Tank Passed 90 Gullies & Drainage Channel WS21A Passed 91 WS21A WS21 Passed 92 Weak Stream Effluent Tank Retention Pond 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

93 P3 Floor Drains Passed 94 QC Labs WS13B Passed 95 WS13B WS18 Passed 96 WS18 WS19 Passed 97 WS23 WS18 Passed 98 Channel East of WS Tank WS23 Passed 99 Channel West of B402/403 WS23 Passed 100 WS24 WS23 Passed 101 DIW Drain (South Wall) WS24 Passed 102 DIW Floor Gully WS24 Passed 103 WS25 WS23 Passed 104 WS25B WS25 Passed 105 OP3 Drainage Channel WS25B Passed 106 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

107 Weigh Room 1 WS39 Failed 108 Weigh Room 2 WS39 Failed 109 Weigh Room 3 WS40 Failed 110 WS39 WS40 Passed 111 WS40 WS41 Failed 112 Store Room Channel WS41 Passed 113 Odourless Chem. Channel WS41 Passed 114 Water Sen. Room Channel WS line WS41 to WS43 Passed 115 WS41 WS42 Passed 116 WS42 WS43 Passed 117 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). A project to upgrade the weigh rooms is currently in progress with new pipeline routing and tie-in being installed which will alter these impaired lines. The lines are currently decommissioned and the new lines will be certified as part of the project which is due to be completed in May 2012. 3.12 Utilities Weak Stream System Table of Results Item No.

From To Result

118 WS11 Sump Failed 119 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

120 AJ F1 Passed 121 F2B F2A Passed 122 F2A F2 Passed 123 F1 F2 Passed 124 F2 F2C Passed 125 F2C F3 Passed 126 F3 F3A Passed 127 F3A F3B Passed 128 F3B F3C Passed 129 F3C F3D Passed 130 F3D Admin AJ Passed 131 F3D F4 Passed 132 F4 F5 Passed 133 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

134 F6 F7 Passed 135 F7 F8 Passed 136 F8 F9 Passed 137 F9 F10 Passed Summary of Results All underground weak stream and foul pipelines and associated tanks from P2 Dryer building passed the hydrostatic test.

3.15 Contractors Compound Foul Sewer System Table of Results Item No.

From To Result

138 SE & O’Sheas F21 Passed 139 F21 F22 Passed 140 Line Contractors F22 Passed 141 F22 F24 Passed 142 F23 F24 Passed 143 F24 Septic Tank Passed 3.16 Effluent Discharge Line Table of Results Item No.

From To Result

144 FE1 FE2 Passed 145 FE2 Parshal flume Passed 146 Parshal flume FE3 Passed 147 FE3 FE4 Passed 148 FE4 FE5 Passed

4.0 Repairs From the integrity testing to date 13 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.

73 Gp 8 Drainage Channel

Sump E Impaired joints in drainage channel.

The drainage channel joints were cleaned and re-sealed.

78 Sump D Sump E A rough joint and an open joint were detected in camera survey.

Pipe was relined to seal these joints.

80 Bund 309 Drainage Channel

Impairment at manhole.

New manhole constructed at tie in between weak stream pipe & Bund 309 drainage channel.

88 WS39 WS22B Camera survey showed 2 tie-in lines not in use.

Pipe was relined to seal off the tie-in connections.

107 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.

108 Weigh Room 2



109 Weigh Room 3



111 WS40 WS41 Impairment in lines.

It is planned to repair the line once new tie-ins from weigh room

project is complete. 118 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 43 Drainage Channel Sump To be retested once repairs

are complete during August 2012 shutdown

46 Pyrophoric Building Channel

WS26A Passed

73 Gp 8 Drainage Channel Sump E Passed 78 Sump D Sump E Passed 80 Bund 309 Drainage Channel Passed 88 WS39 WS22B Passed 107 Weigh Room 1 WS39 Currently decommissioned.

New lines to be tested once Weigh room Project Complete by May 2012.

108 Weigh Room 2 WS39 Currently decommissioned. New lines to be tested once Weigh room Project Complete by May 2012.

109 Weigh Room 3 WS40 Currently decommissioned. New lines to be tested once Weigh room Project Complete by May 2012.

111 WS40 WS41 Currently decommissioned. New lines to be tested once Weigh room Project Complete by May 2012.

118 WS11 Sump Passed

6.0 Conclusion Of the one hundred and forty four pipelines, manholes and sumps integrity tested to date thirteen were found to be compromised. All thirteen 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. Eight of these lines were repaired and passed the integrity retest and of the remaining five four are scheduled to be repaired/replaced and retested by May 2012 and the other during shutdown in August 2012. The remaining four untested lines are scheduled to be tested by the end of the site shutdown which has been deferred to August 2012.

Page 1 of 9

APPENDIX 9 EMP – Report on the Progress made and proposals being developed to minimise water demand and the volume of trade effluent. Report 2011


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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 2011 of water was 20% less than in 2010 and 59% less than 2009. This represents an overall consumption reduction of over 145,600 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 9

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 main source of water being used in the facility. In January 2011 the site started to use water from an onsite Ground water well. This is providing water to the Filter belt press in the WWTP. 3.0 Water Users The following list is comprised of the main water users on site in order of consumption for the 2011 calendar year.

Breakdown of Towns Water Usage on the Little Island Site for 2011

Page 4 of 9

4.0 WATER FLOWRATE OVER 2009, 2010 & 2011

The water consumption graph illustrates the monthly water usage on site for 2009, 2010 and 2011. 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 and Q1 2011 to reduce the volume for water used on site. The effect of this is evident in the 59% drop in annual consumption from 2009 to 2011. 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. In the summer of 2011 a temporary Water chiller was installed. While this was primarily installed to reduce the reactor cooling times during the summer, it also significantly reduced the water consumption used for cooling onsite. There was no summer shutdown in July 2011.

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5.0 BREAKDOWN OF WATER USAGE ON SITE

The Sankey Diagram 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 2011. 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, P2&TO, Utilities & WWTP

Page 6 of 9

6. Volume of Waste Water to WWTP Graphs No.1 illustrates the trend on site with respect to final effluent volumes being sent to the WWTP. No Shutdown took place in 2011. This variation in flow can be contributed to: (i) Process changes on site (ii) The use of water for cooling. (iii) Continuous monitoring of solenoids valves on vacuum pumps. Graph No.1 Effluent Volumes for 2011

WWTP EFFLUENT 2011

0

1000

2000

3000

4000

5000

6000

7000

8000

9000

10000

Janu

ary

Februa

ryMarc

hApri

lMay

June Ju

ly

Augus

t

Septem

ber

Octobe

r

Novembe

r

Decembe

r

Month

Efflu

ent (

M3)

Flow (M3)

In September, 2012 the site will transition to manufacture of product W through the product Z process. This process change will result in modifications to the nature and type of flows to the Waste Water Treatment Plant. These changes are currently been assessed and analysed. A project is being rolled out to ensure that this transition is as efficient and effective as possible.

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7.0 Projects undertaken in 2011 for the reduction in use of water. The following projects were completed in 2011

Splitting Chilled Water and LTC systems: Feasibility study into having both a dedicated site Low Temperature coolant system and chilled water system. This was deemed non feasible due to poor payback and highly invasive construction. However a alternative approach was taken to installing a closed cooling water loop to select user. See below projects for 2012.

Drill water well onsite: In January 2011 the ground water well was installed an

commissioned. It has been running successfully since. The ground water well is providing water to non potable, low quality requirements. Ie the WWTP Belt press. Assigned to :– J Hunter Target: Q1 2011 Impact : Reduce volume of towns water used.

Continued Process Optimisation: Survey individual users 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.

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8.0 Future Planned projects for 2012.

Closed Cooling Water loop for OP1: As a result of a survey of individual water users onsite it was found that a significant portion of water users could be piped to a closed cooling water loop. Plan is to use reuse a redundant chiller to provide cooling to this closed cooling water system. Aim to reduce the water consumption by a further 220,000m3 pA. (42%) Assigned to :– Terry Anderson. Target: Q3 2012 Impact : Reduces flow to storm water and reduces volume of towns water used and reduces electrical load on site chillers

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.

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9.0 Monitoring and reporting. Continuous reviews are ongoing on the Little Island site to identify areas where water usage can be minimised. Water consumption is tracked using the M&T system and using monthly Cork Co.Co. bills. This is reported at the Energy/Water team meetings and water consumption is trended in the month Energy/Water report. The site is committed to achieving a corporate target of a 2% reduction in water usage from 2011 to 2012. Our achievement of this target is tracked on the Monthly Energy and water report. Action is taken to investigate reasons for this target not being met. Water reduction project are captured as both water conservation and waste minimisation projects and are included in the sites EnMP and EMP.

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