Pfizer Ireland Pharmaceuticals, Environmental Liabilities ... · funding mechanism to cover the expected liability. The latter case applies usually to, for example, on-site landfill

Pfizer Ireland Pharmaceuticals\49340764 Pfizer Pottery Road ELRA 2010\DURP0001/JAG/JAG

Pfizer Ireland Pharmaceuticals, Pottery Road

Environmental Liabilities Risk Assessment

2010 Review

16 February 2011 Final

49340764 /

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Pfizer Ireland Pharmaceuticals, Pottery Road Environmental Liabilities Risk Assessment 2010 Review


16 February 2011

Final

Project Title: Pfizer Ireland Pharmaceuticals, Pottery Road

Report Title: Environmental Liabilities Risk Assessment

2010 Review

Project No: 49340764

Report Ref:

Status: Final

Client Contact Name: Helena Mulvihill

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

Name Signature Date Position

Prepared by

John Grumley

16-Feb-2010 Project Manager

Checked & Approved by

Peter Hassett

16-Feb-2010 Project Director

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16 February 2011

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CONTENTS

Section Page No

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

1.1 General............................................................................................................................. 1 1.2 Environmental Liabilities Risk Assessments.................................................................... 2 1.3 Basis for the ELRA........................................................................................................... 3 1.4 Key Assumptions.............................................................................................................. 3 1.5 Structure of the ELRA ...................................................................................................... 4 1.6 Limitations ........................................................................................................................ 4

2. OVERVIEW OF PIP ......................................................................................................... 5

2.1 Site Location..................................................................................................................... 5 2.2 Site History ....................................................................................................................... 5 2.3 Site and Process Description of Main Site....................................................................... 7

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

3.1 General........................................................................................................................... 13 3.2 Complexity...................................................................................................................... 13 3.3 Environmental Sensitivity ............................................................................................... 14 3.4 Compliance Record........................................................................................................ 16 3.5 Risk Category................................................................................................................. 17

4. HISTORICAL ENVIRONMENTAL LIABILITIES ........................................................... 18

4.1 Releases to Air ............................................................................................................... 18 4.2 Releases to Process Water and Surface Water Discharge Sewer................................ 19 4.3 Soil and Groundwater Quality ........................................................................................ 23

5. EXISTING ENVIRONMENTAL CONTROLS AT PIP .................................................... 27

5.1 General........................................................................................................................... 27 5.2 Environmental Management .......................................................................................... 27 5.3 Releases to Atmosphere................................................................................................ 27 5.4 Releases to Surface Water and Groundwater ............................................................... 28 5.5 Emergency Planning/Preparedness............................................................................... 29 5.6 Prevention of Fire ........................................................................................................... 29

6. SITE SPECIFIC ELRA................................................................................................... 31

6.1 General........................................................................................................................... 31 6.2 Methodology-Risk Identification, Likelihood and Consequence .................................... 32 6.3 Identification of Risks at PIP .......................................................................................... 36 6.4 Assessment of Risks at PIP ........................................................................................... 55 6.5 Risk Prevention, Mitigation and Management ............................................................... 58

7. FINANCIAL PROVISIONS ............................................................................................ 64

7.1 Current Financial Provisions .......................................................................................... 64

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16 February 2011

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CONTENTS

Section Page No

7.2 Assessment of Pfizer Financial Provision ...................................................................... 65

8. LIMITATIONS ................................................................................................................ 67

9. COPYRIGHT.................................................................................................................. 67

APPENDIX A - SITE PLAN

APPENDIX B - STATEMENT OF PARENT COMPANY FINANCIAL GUARANTEE

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Pfizer Ireland Pharmaceuticals Dun Laoghaire ELRA

Page 1

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1. INTRODUCTION

1.1 General

Pfizer Ireland Pharmaceuticals, Dun Laoghaire (PIP) operate a manufacturing facility at

Pottery Road, Dun Laoghaire, Co. Dublin.

PIP was granted an Integrated Pollution Control Licence (Register Number P0019-01 by

the Environmental Protection Agency (EPA) on the 03 October 1995 for the manufacture

of pesticides, pharmaceutical or veterinary products and their intermediates. This licence

was reviewed and replaced by the Integrated Pollution Prevention and Control Licence

(IPPC) (Reg. No. P0019-02) issued by the Environmental Protection Agency (EPA) on

the 14 November 2006 for:

‘The use of a chemical or biological process for the production of basic pharmaceutical

products.’

Clause 12.3 of the IPPC Licence requires the preparation and submittal to the Agency of

an Environmental Liabilities Risk Assessment (ELRA). The specific requirements are as

follows:

12.3.2 The licensee shall arrange for the completion by an independent and

appropriately qualified consultant, of a comprehensive and fully costed

Environmental Liabilities Risk Assessment (ELRA), which addresses the

liabilities from past and present activities. The assessment shall include those

liabilities and costs identified in Condition 10 for execution of the

RMP/CRAMP. A report on this assessment shall be submitted to the Agency

for agreement within twelve months of date of grant of this licence. The ELRA

shall be reviewed as necessary to reflect any significant change on site, and in

any case every three years following initial agreement: review results are to be

notified as part of the AER.

12.3.3 As part of the measures identified in Condition 12.3.1, the licensee shall, to

the satisfaction of the Agency, make financial provision to cover any liabilities

identified in Condition 12.3.2. The amount of indemnity held shall be reviewed

and revised as necessary, but at least annually. Proof of renewal or revision of

such financial indemnity shall be included in the annual ‘statement of

measures’ report identified in Condition 12.3.1.

The EPA Guidance Document entitled “Guidance on Environmental Liabilities Risk

Assessment, Residuals Management Plans and Financial Provision, copyright 2006) – ”

(hereafter referred to the EPA ELRA Guidance Document 2006) was used in the

preparation of this Environmental Liabilities Risk Assessment update in 2010.

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1.2 Environmental Liabilities Risk Assessments

Any industrial site has the potential to generate environmental liabilities, i.e. damage to

the environment, which must be remedied, such remediation associated with a

quantifiable financial cost.

Environmental liabilities may arise from anticipated or foreseeable events, i.e. known and

quantifiable releases to the environment, which arise due to the day-to-day operation of

the facility. Examples of such potential liabilities include the long-term management and

aftercare of a tailings pond at a mining or minerals refining site or on-site landfill of waste

materials. For a site subject to IPPC Licensing, regular emissions to air, water and land

has been the subject of detailed quantification and consequence analysis, i.e.

assessment of the impact of emissions, during the licence application process. The

resulting IPPC licence either establishes emission limits and other conditions at levels,

which prevents the arising of new liabilities, or may require bonding or other secure

funding mechanism to cover the expected liability. The latter case applies usually to, for

example, on-site landfill activities.

Environmental liabilities may also arise from unanticipated or unforeseen events. Such

events may be generally classified under the following headings:

• Events which are sudden and which are identifiable as an incident or series of

related incidents which give rise to an environmental liability concurrent with the

incident or shortly thereafter;

• Event’s, which develop gradually or go unnoticed for a long period of time, which

gradually gives rise to an environmental liability.

Examples of the former would include explosion/fire or accidental release of chemicals

from a storage tank to a watercourse.

An example of the latter would be leaks in underground storage tanks or transfer lines,

which would result in the gradual build-up of soil and/or groundwater contamination.

The costs of dealing with unanticipated or unforeseen events are usually issues, which

are addressed in the insurance cover for the industrial site in question.

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The Environmental liability risk assessment (ELRA) considers the risk of unplanned

events occurring during the operation of a facility that could result in unknown liabilities

materialising. Based on an initial risk categorisation of the activity into Low, Medium or

High risk, different approaches are recommended according to the risk category. Simple

approaches are proposed for low risk facilities to more detailed site-specific approaches

involving detailed environmental liability risk assessment for higher risk facilities.

1.3 Basis for the ELRA

The basis of this ELRA is as follows:

� Information from the preparation of the original ELRA in 2007.

� A review of changes to the activities carried out at the site since 2007, including

processes and services.

� A review of the following documentation supplied by PIP:

- IPPC License Application Files;

- Annual Environmental Reports for 2008 and 2009;

- Residuals Management Plan review (March 2010); and

- Incident Report Forms for 2007, 2008 and 2009.

� Publicly available information from the EPA.

� URS reports on soil and groundwater management prepared for submission by

Pfizer to the EPA.

� Identification of existing and potential hazards, including evaluation of materials

and wastes generated.

� Consideration of historic environmental incidents and remediation works

undertaken.

Based on the desk-based study research and discussions with the site’s Environmental

Team, a thorough assessment was made of potential environmental liabilities requiring

remediation to which costs could be assigned. Remedial actions are described for these

and remediation or corrective costs are identified.

1.4 Key Assumptions

There is a reasonable degree of subjectivity and uncertainty involved in Environmental

Liabilities Risk Assessment so it is important to identify any assumptions at an early

stage. These are as follows:

� It is assumed that PIP maintains site conditions in accordance with their IPPC

licence (Reg. No. P0019-02) and greenhouse gas emissions permit (Permit No.

IE-GHG155-02). No provision has been made for costs associated with any

criminal proceedings that could arise. It is understood that there is good will and a

strong desire by PIP to remain complaint with relevant legislation and EPA

requirements.

� The ELRA has been based upon historic and current operational activities. It

does not consider potential environmental liabilities associated with significant

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changes in use of the site, such as redevelopment for other commercial or

industrial purposes by PIP or any other party, as these would require a separate

risk assessment exercise should they arise. Furthermore, the financial provision

discussed in this report relates specifically to the environmental risks associated

with historic and current operational activities (excluding the Residual

Management Plan (RMP)). However, the ELRA does make reference to the costs

of the final clean up of the site after closure as this is set out in the sites RMP

(revised March 2010). The RMP is specifically catered for under Condition 10 of

the IPPC License Reg. No. P P0019-02.

1.5 Structure of the ELRA

The ELRA report is structured as follows:

Section 2 provides an overview of the PIP facility including details of existing process,

buildings and structures present on the site at the time this report was prepared.

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

the PIP facility.

Section 4 provides an overview of the historical environmental liabilities at the facility.

Section 5 provides an overview of the existing measures in place at the site to minimise

possible environmental liabilities associated with the facility.

Section 6 described the site specific risk assessment, which was carried out for the

facility. It includes section on Risk Identification, Occurrence Likelihood, Severity

Assessment, Risk Evaluation and Prevention/Mitigation.

Section 7 describes the financial provisions in place to deal with any unknown liabilities

and identifies possible gaps between the level of cover provided and the level of risk

associated with the facility.

1.6 Limitations

URS has prepared this report for the sole use of PIP and for submission to the EPA in

accordance with generally accepted consulting practices and for the intended purposes

as stated in the agreement under which this work was completed. No other warranty,

expressed or implied, is made as to the professional advice included in this report.

Unless otherwise stated in this report, the assessment assumes that the site and facilities

continue to be used for their current purpose.

The conclusions and recommendations contained in this report are based upon

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

provided by those relevant bodies from whom it has been requested.

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2. OVERVIEW OF PIP

2.1 Site Location

The site is located on Pottery Road approximately 3.5km south west of Dun Laoghaire

town centre in County Dublin. A site plan is shown in Appendix A. Surrounding land use

is primarily residential with neighbouring land use as follows:

• East: Light industrial units, a sports ground and some residential properties;

• South: Residential and a “pitch & putt” golf course. A building (at one time an

EPA regional laboratory) is situated approximately 100 m from the east site

boundary. The building is now a motor company service centre;

• West: Pottery Road and across this road, residential properties; and

• North: National Rehabilitation Hospital on extensive grounds which adjoin the

site. Further to the north east, and across Pottery Road, there is a small industrial

estate with a mix of commercial and industrial facilities (approximately 1 km from

the site).

The closest residential properties are those along the south east of the site boundary and

are within 20m of the site boundary.

2.2 Site History

URS retrieved information on site history from:

• Environmental Impact Statement information prepared as part of the 2005 to

2007 site redevelopment project;

• Previous site investigation reports; and

• Residual Management Plan updated in March 2010.

A brief description of the site history is as follows:

• At, or before, 1912 and up to, or before, 1940: 6-inch Ordinance Survey maps

indicate the presence of a sand quarry extending roughly north west to south east

of the site, beginning approximately where the Adams Building was originally

standing;

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• 1940 to 1969: - although this timeframe has not been verified, it appears that the

old sand quarry, now disused, was used to landfill domestic rubbish, thought to

be from ‘the Corporation’ (in reference to Dublin Corporation, a local authority). A

geotechnical investigation undertaken in 1997 concluded that a second phase of

filling occurred when the Adams and PM1 buildings were constructed. The

geotechnical report concluded from soil sampling that there was no evidence to

suggest that this second phase of filling contained domestic waste. Instead, it

was concluded in the 1997 geotechnical report that the fill material was

construction related.

• 1972: Warner-Lambert moved its ethical and consumer products manufacturing

facility from Abbey Road, Blackrock, Dublin to the site at Pottery Road. The

product manufactured was gum base in one building (the Adam’s Building);

• 1973: Manufacturing was expanded in the Adams Building to produce finished

gum. Employment was expanded from 75 to 300 persons;

• 1976: A General Diagnostics Building (the current building called Production

Module 1, or PM1) was constructed and employment expanded to 500 persons.

In this building, Warner Lambert commenced manufacturing of medical

diagnostic reagents;

• 1980: Suites for the manufacture of drug substances Elase and Thrombin were

added to PM1. Aseptic production commenced;

• 1981: Finished gum manufacturing ceased (i.e., manufacturing limited to gum

base);

• 1984: Medical diagnostic reagents manufacturing ceased in PM1;

• 2000: Warner-Lambert was purchased by Pfizer. The Adams Building was leased

out by Pfizer to Cadbury Schweppes. The Warner-Lambert confectionary

businesses were subsequently sold to Cadbury Schweppes;

• 2004: Pfizer purchased 7 acres of land from neighbouring National Rehabilitation

Hospital;

• 2006: Gum base manufacturing ceased and Cadbury Schweppes moved out of

the Adams Building. Later that year the Adams Building was demolished;

• 2005/2007: The site was substantially redeveloped in a site expansion project

(called the Aseptic Expansion Project). The expansion included a new Central

Utilities Building (CUB), production building PM2, Waste Management Building,

Personnel Support Facility Building and Warehouse on the expanded site area;

and

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• 2009: The first commercial batch produced in PM2 was in 2009. The new effluent

treatment system installed in 2007 was also commissioned during this time.

2.3 Site and Process Description of Main Site

The pharmaceutical plant is primarily engaged in the manufacture of sterile

pharmaceutical products. The site currently employs 260 people in the production of a

range of pharmaceutical products. Manufacturing operations normally operates three

shifts, starting at 7am on Monday and ending 4am on Saturday.

Pfizer recently announced its intention so exit operations on a phased basis by 2014.

Table 2.1 below summarises the key site buildings. The balance of the site comprises:

• A complex of smaller structures at the southern end of the site, including offices,

water storage tanks, pump house, a workshop, and a contractors compound. The

site contaminated firewater retention tanks are located there also;

• Main site car-park, roadways and entrance security building;

• A landscaped area in the centre of the site which is the footprint of the former

chewing gum base factory (called the Adams Building). The Adams Building was

demolished in 2006; and

• An Electricity Supply Board of Ireland (E.S.B) substation, built in 2005 that is

identified within the site boundary on the far north end. However, the land on

which the substation is built is owned by the E.S.B. There is a separate

entrance/exit to this substation from Pottery Road, jointly controlled by the E.S.B.

& Pfizer.

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Table 2.1: Site Main Buildings

Building Construction

Date

Approx.

area (m2)

Current Main

Use

Description

Production

Module 1

(PM1)

Various 13,000

Bio/Biologics

production,

aseptic filling,

drying and

packaging

This two storey building contains production areas and some of the on-site

laboratories as well as a penthouse plant room. The Biologics Production Area

and Suite 1 are located on the ground floor. Suite 3, the Bioprocess production

area and laboratories (Chemistry and Biologics) are located on the first floor. The

production areas in PM1 are detailed as follows:

• Biologics Production Area: The Biologics Production Area (Bulk) is a non-sterile

processing area used to manufacture Fibrinolysin. Fibrinolysin is an intermediate

product which is used in the preparation of Elase Vials in Suite 3 and

Fibrinuclease Powder in Suite 1.

• Suite 1: Suite 1 is a dedicated facility used for filling, lyophilisation (freeze

drying) and packaging of Fibrinulcease powder. Fibrinulcease powder is a bulk

freeze dried powder which is exported to PIP affiliates for further processing to

Elase ointment.

• Suite 3: Suite 3 is used for aseptic formulation and filling, lyophilisation (as

appropriate) and packaging of sterile products. Suite 3 is operated as a multi-

product facility. Suite 3 produces the following products: Ketalar, Ketanest S,

Elase, Cerebyx, Vfend, Azithromycin and Fosfluconazole.

• Bio-Process Production Area: the Bio-Process production area, which was

previously the Biotech Suite, is used for the purification, filling and lyophilisation

(as appropriate) of pegylated products. It is currently used for the manufacture of

Macugen and Pegvisomant.

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Date

Approx.

area (m2)

Current Main

Use

Description

Production

Module 2

(PM2)

2006/2007 6,878 Aseptic filling

and packing

This is two storeys high with penthouse plant rooms. The production area is

located on the first floor and plant rooms are located on the ground floor as well

as the penthouse. The production area within PM2 is used for aseptic formulation

and filling, lyophilisation (as appropriate) and packaging of sterile products. PM2

is also operated as a multi-product facility. PM2 currently produces the following

products: Azithromycin, Vfend and Somavert.

Warehouse 2006/2007 5,386

Raw material

and finished

production

storage

including a large

Quarantine

compound

Stores the majority of dry solid raw materials that arrive on-site. Some final

product is also stored in the warehouse prior to shipping off site.

Personnel

Support

facility (PSF)

2006/2007 3,780

Offices/laborator

ies, canteen and

staff facilities

The PSF is two storeys high with a penthouse plant room. The canteen is located

on the ground floor and laboratories including the Microbiology Laboratory and a

HPLC Laboratory are located on the first floor.

Central

Utilities

Building

(CUB)

2006/2007 2,121

Provision of key

utilities to

production

buildings

(steam,

compressed air,

cooling water)

A two storey high building contains various utilities such as boilers, chillers, air

compressors and transformers.

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Date

Approx.

area (m2)

Current Main

Use

Description

Waste

Management

Building

2006/2007 Approx 150

Waste

Autoclaving

Final waste load

preparation.

Comprising of tank storage and waste/chemical storage areas.

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There is an underground utilities tunnel linking the pump house located on the far south

end of the site and the PM1 building. A link corridor links the PSF building and PM2.

A pipe rack connects the CUB with the production facilities and warehouse.

The process wastewater balance tanks (2 No.) are located east of building PM1. There is

an older wastewater treatment balance tank and associated sub-surface pump sump

located south of PM1. However, the latter wastewater treatment infrastructure is no

longer used.

The other main features of the site are as follows:

• Switch Room;

• Security Gatehouse;

• Cooling Towers; and

• Nitrogen Pad.

2.3.1 Ancillary Operations

Ancillary operations associated with the production facilities are detailed below:

2.3.1.1 Ultra Pure Water Systems

Ultra pure water is one of the most important plant services; it is used in all stages of the

production and analysis in the production plant. Ultra pure water is circulated throughout

the main pharmaceutical buildings supplying all production areas and laboratories. The

process for producing ultrapure water involves passing potable water through a variety of

filtration steps.

2.3.1.2 WFI (Water for Injection) Systems

The WFI Systems (x3) supplies Suite 3, PM2 and Bio-Process production. WFI is

produced by generating steam from the purified water and then condensing this steam.

The condensate is then distributed to the production areas as WFI.

2.3.1.3 CIP/SIP Systems

Clean in Place/Steam in Place (CIP/SIP) system is used to clean the product holding and

mixing tanks, filling lines, filling pumps, filling needles and all product transfer lines. The

CIP system involves rinsing the tanks and lines with purified water, WFI orthophosphoric

acid and sodium hydroxide solutions. Upon completion of the CIP, the entire system is

steam sterilised in place (SIP) using clean steam.

2.3.1.4 Glycol Systems

The plant is equipped with chilled glycol systems. These systems supply all production

areas with glycol at -6oC to facilitate product cooling. At various points throughout the

plant the glycol can be reheated and used as a heating medium.

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2.3.2 Manufacturing Activities

The main manufacturing activities on site include:

• Bio-pharmaceutical production of active pharmaceutical ingredients (APIs) by

extraction of proteins in a fractionation process;

• Non-sterile pharmaceutical product production formulation and filling; and

• Aseptic formulation filling: - APIs from other Pfizer sites are compounded in

aqueous solutions, sterile filtered and filled into sterile glass vials. Downstream

processing includes freeze drying (lyophilisation), and packaging.

Production does not involve chemical reactions.

The main final products are summarised in Table 2.2, below.

Table 2.2: Summary of Main Site Products

Brand Name Active Product Benefit

VFEND Voriconazole Anti Fungal

Zithromax Azithromycin Antibiotic

CerebyxB Fosphenytoin Anti Epileptic

Prodif Fosfluconazole Anti Fungal

Ketanest/Ketalar Ketamine General Anaesthetic

Elase Fibrinolysin Wound Healing

Somavert Pegvisomant Growth Hormone Inhibitor

Macugen Pegaptanib Sodium Macular degeneration

Most of the products are manufactured to final product status. Some products are

finished in other Pfizer sites worldwide. Batch sizes vary to product and range from

approximately 19 to 82,500 vials per batch.

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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 into Risk Categories (1-3) and thereby select the specific ELRA

and Financial Provision (FP) requirements that will be needed. The risk assessment

decision matrix outlined in the EPA ELRA Guidance Document 2006 was used.

The risk category assigned to the facility depends on the complexity of operations at the

site, the environmental sensitivity of the receiving environment and the compliance record

of the facility.

• Complexity – the extent and magnitude of potential hazards present due to the

operation of the facility (e.g. a function of the nature of the activity, the volumes of

hazardous materials stored on site etc.). A Complexity Band (G1 least complex to

G5 most complex) for each class of activity has been assigned and included in a

Look-Up Table (Appendix B of the EPA ELRA Guidance Document 2006).

• Environmental Sensitivity – the sensitivity of the receiving environment in the

vicinity of the facility, with more sensitive locations given a higher score (e.g. the

presence of aquifers below the site, groundwater vulnerability, the proximity to

surface water bodies and their status, the proximity to sensitive human receptors,

etc). The environmental sensitivity is calculated on a site-specific basis using a

sub-matrix (Table 3.1).

• Compliance Record – the compliance history of the facility.

Each aspect is multiplied to give the Total Score for the facility, and this can be used to

place the facility into an appropriate risk category as follows:

• Risk Category 1 = Score < 5

• Risk Category 2 = Score 5 - 23

• Risk Category 3 = Score = > 23.

Once this has been completed, the licensee proceeds through the relevant steps of ELRA

and FP 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 ELRA

Guidance Document 2006.

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The Complexity Band is used to determine the value used in the Operational Risk

Assessments as follows:

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

In 14th November 2006, PIP was granted a revised IPPC License (Registration No.

P0019-02). The relevant complexity band for PIP according to the EPA’s ELRA Guidance

Document 2006 is as follows:

• IPPC activity class 5.16: the use of a chemical or biological process for the

production of basic pharmaceutical products.

PIP produces approximately 200 tonnes of finished product and intermediate annually,

which is less than 2000 tonnes per annum and therefore has been assigned a complexity

band G3 and receives a score of 3 according to the ELRA complexity banding.

3.3 Environmental Sensitivity

A sub-matrix for environmental sensitivity is outlined in Table 3.2. This considers 6 key

potential environmental receptors and assigns individual scores that are added together

to arrive at a total environmental attribute score. The scoring system used is outlined in

EPA ELRA Guidance Document 2006. The total environmental attribute score is used to

look up the environmental sensitivity classification in Table 3.1 below. The environmental

sensitivity sub-matrix has been developed based on professional judgment and with

reference to the system designed in the EP OPRA Scheme by the Environment Agency

(UK). The environmental sensitivity classification is used in the operational risk

assessment to calculate the total score.

The key receptors include:

• Human occupation;

• Groundwater protection;

• Sensitivity of receiving water;

• Air quality & topography;

• Protected ecological sites; and

• Sensitive agricultural receptors.

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Table 3.1 Environmental Sensitivity Classification

Total Environmental Attribute Score Environmental Sensitivity Classification

Low <7 1

Moderate 7-12 2

High >12 3

Table 3.2: Environmental Sensitivity Sub-Matrix

Environmental Attribute Environmental

Attribute Score Note 1, 2

Human Occupation

<50m

50m-250m

250m–1,000m

>1km

5

3

1

0

Groundwater Protection

Regionally Important Aquifer

Locally Important Aquifer

Poor Aquifer

Vulnerability Rating – Extreme

Vulnerability Rating – High note 3

Vulnerability Rating - Moderate

Vulnerability Rating - Low

2

1

0

3

2

1

0

Sensitivity of Receiving Water

Class A

Class B

Class C

Class D

Designated Coastal & Estuarine Waters

Potentially Eutrophic Coastal & Estuarine Waters

3

2

1

0

2

1

Air Quality & Topography

Complex Terrain

Intermediate Terrain

Simple Terrain

2

1

0

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Environmental Attribute Environmental

Attribute Score Note 1, 2

Protected Ecological Sites

Within or directly bordering protected site

<1km to protected site

>1km to protected site

2

1

0

Sensitive Agricultural Receptors

<50m from site boundary

50m-150m from site boundary

>150m from site boundary

2

1

0

Note 1 – The environmental attribute which is relevant to the PIP facility is underlined and bold. Note 2 – The scoring system used is taken from the EPA ELRA Guidance Document 2006.

Based on the above environmental sensitivity sub-matrix, the total environmental attribute

score for PIP is 8 which indicates that that the environmental sensitivity classification for

the site and surrounds is 2.

3.4 Compliance Record

The compliance record score is derived from the compliance history of the facility and

whether the activities carried on resulted in contamination or pollution.

For newly licensed facilities and those operating without non-compliance of emission

limits, then these are classified as Compliant/New Facility and have a score of 1.

Licensed facilities with administrative non-compliances only are classified as

administrative non-compliant and have a score of 2.

Licensed facilities with minor non-compliances (< 5 non-compliances in 12 month period)

are classified as being Minor Non-Compliant and have a score of 3. Facilities with minor

soil and groundwater contamination (i.e. those with concentrations above background but

not posing risk to the environment) are also considered in the class.

Licensed facilities with major non-compliance history (≥ 5 non-compliances in 12 month

period) and/or those with significant soil and groundwater contamination (i.e. requiring

remediation and/or long-term monitoring requirements) are classified as Major Non-

Compliant/Significant Ground Contamination and have a score of 4.

Those facilities with repeated non-compliances (>10 Total) during a 12-month period are

classified as Repeat Non-Compliance and have a score of 5.

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As part of the preparation of this ELRA, documentation relating to IPPC Licence

compliance and prosecutions was examined. This documentation review demonstrated

that the site has a good record of compliance with the Conditions of the IPPC Licence. In

the last three years, there have been 4 non-compliances with the IPPC Licence. These 4

non-compliances are related to ELV exceedance for emissions to sewer.

In addition to the above non-compliances, the site is carrying out a separate investigation

into trichloroethylene levels in groundwater as detailed in section 4.3.2. This investigation

has been conducted with EPA oversight since 2005.

Between January 2008 and January 2011, the site received a total of 3 complaints. In all

cases the site resolved these issues.

Although there is a very good history of compliance at the site with regard to the IPPC

Licence, a compliance record score of 4 is judged appropriate for the site due to the

historic soil and groundwater contamination issue.

3.5 Risk Category

The proceeding subsection of this section has determined the:

• Complexity Score (G3) = 3

• Environmental Sensitivity Score = 2

• Compliance Record Score = 4

The product of these scores is used to calculate a total score, which is then used to

assign the site specific risk category (Table 3.3). The product of the above scores is 24,

which according to Table 3.3 below indicates that a risk category of 3 is applicable to the

PIP site.

Table 3.3 – Risk Category

Risk Category Total Score

Category 1 <5

Category 2 5-23

Category 3 >23

The PIP site is classified in risk category 3 and therefore the guidance provided in the

EPA ELRA Guidance Document 2006 for high-risk facilities was used when carrying out

this assessment.

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4. HISTORICAL ENVIRONMENTAL LIABILITIES

4.1 Releases to Air

With regard to sudden and accidental releases to air, there is no history of:

� Major fires or explosions at the site;

� Run-away reactions resulting in significant discharge to atmosphere; and

� Significant accidental releases of hazardous gases.

Consulting the Annual Environmental Reports, the monitoring results for emissions to

atmosphere were examined for 2007, 2008 and 2009.

Owing to the nature of production and low organic solvent usage, the site is not regulated

under the Emissions of Volatile Organic Compounds from Organic Solvents Regulations

2002 (S.I. No. 543 of 2002).

In an annual audit report in 2009, the EPA raised a non-compliance related to a reported

volumetric flow rate of emissions to air from emission point A2-1. In response to the

alleged non-compliance, the site undertook an investigation into the alleged non-

compliance and concluded that the results obtained were not valid, due to the location of

the sample port. Independent verification of the extract fan rating demonstrated that the

fan is a fixed speed fan. Additional extraction flow rate monitoring was undertaken by a

third party and this testing demonstrated that the volumetric flow rate was below the

licence emission limit value.

Fugitive emissions are largely generated in the following operations on the site:

• Wastewater treatment;

• Bulk storage tank filling; and

• Building ventilation.

The site undertook an internal risk assessment on fugitive emissions in 2007. The

assessment covered leak detection on the catchment system specified in the IPPC

licence condition 3.12 and the IPPC licence condition 6.9 on reducing fugitive emissions.

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The assessment considered various activities, mainly filling diesel tanks, acid and caustic

tanks, chloroform dispensing, solvent handling and waste handling. Using a risk scoring

system, the site concluded that there is a negligible risk to the environment from fugitive

emissions with a very low potential to generate substantial fugitive emissions. Therefore,

the site concluded that no additional controls for fugitive emissions were required.

Based on a review of the historical data for the facility, there is no evidence to suggest

that releases from the site to air have resulted in the development of any off-site

environmental liability.

4.2 Releases to Process Water and Surface Water Discharge Sewer

4.2.1 Overview

With regard to sudden and accidental discharges, there is no history of:

� Major fires or explosions at the site resulting in significant discharges of firewater;

� Significant failure of the WWTP treatment process; and

� Significant accidental releases of wastewaters in exceedence of the ELV

specified in the sites previous IPC/IPPC Licences.

There are two types of wastewater generated on-site:

• Process effluent; and

• Sanitary wastewater.

Each type of wastewater is conveyed and managed in a separate drainage system on the

site. However, both wastewater streams discharge to the same Dun Laoghaire Rathdown

County Council foul sewer drain that runs along Pottery Road. This sewer connects up

with the main Council sewer network that in turn discharges to the Shanganagh

Treatment Works. The treatment works is located approximately 3.5 km south east of the

site in the town land of Shanganagh.

The Shanganagh Treatment Works is currently being upgraded. Earlier in 2010, the first

main phase of the treatment works upgrade was completed to provide a replacement

preliminary treatment plant (screening and grit removal). Site management informed URS

that it is planned by the local authorities to continue to upgrade the treatment works to

provide secondary wastewater treatment (activated sludge) and sedimentation,

scheduled for commencement in June 2011. The Shanganagh Treatment Works

discharges to Killiney Bay through a 1.7 km long sea outfall.

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4.2.2 Surface water

Surface water, emissions from the site consists of rainfall runoff from roofs, site hard

standing areas and car park areas.

Records evaluated from 2007 - 2009 indicate that there have been no compliance issues

with surface water within that period.

On 5th March 1988, an estimated 3200 litres of diesel oil were spilled inside the pump

house to the south of the site1. The incident occurred whilst topping up diesel header

tanks inside the south wall of the pump house. The tanks are still in place and are used to

supply the sprinkler system supply pumps. Some of the spilled diesel was recovered into

drums in the pump house but the majority of the diesel got out into the main surface drain

running east to west down the access road adjacent to the pump house.

It is thought by site management that diesel (quantity not recorded or estimated) entered

the open stream (the Deans Grange stream) behind Little Meadow Estate.

The surface drain pipe and area were cleaned with detergent and soaked up. The

manhole near the road was pumped clean. All surface water and sewerage drains were

filled in with concrete in the area of the pump-house. A sump was created instead to

capture water or diesel spills.

Warner Lambert was prosecuted in the District Court due to the spill which closed the

matter with relevant authorities at the time.

4.2.3 Process Effluent

Process effluent, or wastewater, results from:

• The cleaning of process equipment;

• The washing of vials;

• The washing of floor and wall surfaces; and

• The protein extraction fractionation process in the biologics production area

(dilute quantities of bovine serum and ammonium sulphate).

Equipment is washed mainly with hot water, caustic and detergent (via Cleaning in Place

systems), or isopropyl alcohol. Floor and wall washings contain detergent or disinfectant.

The steam boilers, purified water and water for injection production systems, freeze

dryers, cooling towers and chillers produce wastewater streams. This wastewater

contains dissolved salts as well as residues of proprietary chemical formulations used to

treat the boiler and cooling water.

1 Short technical report from Mr. Kevin Delaney of Warner Lambert dated 28 April 1988.

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The following summarises the process effluent conveyance system:

1. Process effluent from the CUB and the warehouse is drained underground to a

pump sump located halfway along the east boundary wall of the warehouse (the

‘south road sump’). From there, the wastewater is pumped via level control

above ground directly to the two main above ground balance tanks (210,000

litres each);

2. Process effluent from PM2 drains to a centrally positioned sump (the PM2 sump)

and from there is pumped on level control above ground to the two main above

ground balance tanks (210,000 litres each);

3. A similar arrangement is in place for the PSF building (via a PSF sump);

4. Process effluent from the PM1 building is gravity fed to the PM1 tunnel sump, a

series of three fibreglass above ground tanks located inside the utility tunnel

between the pump house and PM1. This effluent stream is then pumped above

ground to two large above ground balance tanks (each 210,000 litres in

capacity) located outside the east wall of the PM1 building;

5. In each of the two balance tanks, the effluent is neutralised by the addition of

acid or caustic soda as necessary from an adjacent pair of AST’s. The balance

tanks are agitated and are run to maximise the usage of acid and caustic content

of the Cleaning in Place solutions that are present in the incoming wastewater.

This minimises the need for additional effluent pH correction;

6. The process wastewater is discharged from the balance tanks by gravity. This

flow is monitored by a dual pH probe system, a flow meter and a control valve at

the tank discharge to control the pH and flow to within IPPC licence limit values.

If an excursion from limit values is identified, the flow is automatically stopped;

and

7. The drained effluent passes through a final effluent sump (licensed emission

point SE1) located just inside the south access gate to the site. There is a

refrigerated composite sampler and pH monitoring system at that sump.

All sample non-continuous analysis is conducted by an external laboratory. Site

management reports emissions data annually to the EPA and quarterly to Dun Laoghaire

Rathdown County Council as required in the site’s IPPC licence.

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URS notes that mass loading of contaminants to the receiving Council sewer is low.

Referring to Annual Environmental Reports to the EPA prepared by site management

(2007, 2008 and 2009), the following is a summary of excursions from emission limit

values:

• 2007: 2 excursions, one regarding pH and the other sulphate;

• 2008: 3 excursions, 2 of them due to pH and the third non-conformance with total

daily flow; and

• 2009: 1 excursion due to pH.

In all cases of excursion, the excursion was short in duration and with specific faults

identified and corrective action immediately taken.

Trace concentrations of Chloroform are identified in routine sampling of the process

effluent due to the use of Chloroform in the Elase process in PM1.

In April 2010, the site reported to the EPA an incident where 268 kg of the product

VFEND was discharged through emission point SE1 to the Council sewer. The

investigation undertaken by site following the incident (Site report to EPA dated 27 May

2010) concluded that the concentrations of VFEND in the Council sewer were not

deemed environmentally significant at the receiving Shanganagh Treatment Works.

Toxicity testing of the effluent is undertaken quarterly and compared with the IPPC

licence emission limit value for toxicity of effluent of 10 Toxic Units (TU). The toxicity

testing results for 2009 is summarised in Table 4.1.

Table 4.1: Summary of 2009 Effluent Toxicity Testing

Test Parameter Result (TU)

48 hr LC50 to Tishe battagliai <3.1

15 min EC50 to Vibrio fischeri <2.2

5 min EC50 to Vibrio fischeri <2.2

The EPA periodically takes composite samples from the site effluent monitoring station.

Analysis reports from the EPA demonstrate compliance with SE1 emission limit values.

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4.2.4 Sanitary Wastewater

Sanitary wastewater arises from:

• The changing rooms in the PSF;

• Toilets throughout the site; and

• The on-site canteen.

Sanitary wastewater is gravity drained from various buildings on the site in an

underground drainage system. The sanitary wastewater then combines with the process

effluent downstream of the final effluent sump, i.e. downstream of emission point SE1.

From there the sanitary wastewater flows into the Dun Laoghaire Rathdown County

Council sewer on Pottery Road.

There is a grease trap just west of the PSF building to remove grease products from the

canteen wastewater. The grease trap is serviced regularly on contract.

4.3 Soil and Groundwater Quality

4.3.1 Background

Several ground investigation assessments have already been completed at the Pottery

Road site including a site wide soil investigation by Kirwan during 1969-19742, a soil

investigation of made ground on the site by Irish Geotechnical Services Ltd (IGSL) in

19973 and an investigation in the northern portion of the site in 2003

4. In addition, URS

completed soil and groundwater investigations of the southern portion of the site in 2005

and 2006 (as discussed in Section 4.3.2). Because of these and of on-going groundwater

monitoring required under the terms of the current IPPC licence, the quality of the soil

and groundwater beneath much of the site has been well characterised.

2 Kirwan, R.W. (1974) Report on Site Investigation at Pottery Road, Cabinteely for C.H.Clifton, Esq., Trinity College Dublin for

Site Investigations Ltd.

3 Irish Geotechnical Services Ltd (1997) Report on Ground Investigation at Warner Lambert Ltd., Pottery Road, Dun Laoghaire,

IGSL Report 4050.

4 Irish Geotechnical Services Ltd (2003) Report on Site Investigation for Pfizer, Pottery Road, on Behalf of Jacob’s Engineering,

IGSL Report 9230.

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4.3.2 TCE Works at the Site

A significant body of information on works relating to TCE investigation and assessment in soil

and groundwater at the Site is available in the EPA Enforcement files for P0019-02 in the form

of correspondence and investigation reports. Key enforcement records are referenced as

footnotes in this summary. Pfizer Ireland Pharmaceuticals has recently submitted a detailed

TCE Work Plan to EPA Enforcement which addresses remediation activities proposed and

future monitoring requirements, including timelines. References as appropriate to the TCE

Work Plan are made in this summary document.

During excavation works at the Site conducted as part of utility services installation in late

2005, visual staining was observed at the base of a shallow in-filled trench, at a depth of

approximately one metre. Analysis indicated that the stained soils contained TCE. Impacted

soils encountered during this excavation were removed and ultimately disposed off-Site at an

appropriate facility. Consequently an assessment of the presence of TCE in soil and

groundwater at the Site was undertaken by URS in October 20055. The assessment included

a soil vapour survey, drilling soil bores and construction of groundwater monitoring wells down

gradient of the trench where TCE was initially reported as detected. The results of this

assessment were submitted to the Environmental Protection Agency (EPA) on 5 January

2006.

A second assessment was undertaken in June 20066 and included additional soil sampling up

gradient of where TCE was first identified and further delineation of TCE in groundwater at the

Site. The findings indicated TCE presence in some of the shallow soils; however, the

concentrations observed did not indicate a significant TCE source to be present with Site soils.

Additional groundwater investigations were completed in 2007. The investigation findings,

Site conceptual Site model (CSM), and the Detailed Quantitative Risk Assessment (DQRA)

are presented in the document Detailed Assessment of TCE in Groundwater7. The DQRA

developed site specific assessment criteria (SSAC) for concentrations of contaminants of

concern in soil, groundwater and soil vapour, which represent theoretical concentrations below

which the risks posed by contaminants to the receptor are no longer significant.

In late 2009, additional soil, soil vapour and groundwater data were collected for additional

characterisation as requested by the EPA. The findings were provided in an Additional

Characterisation (AC) report8. The additional information was used to update the DQRA. This

5 Assessment of TCE in Soil and Groundwater, Pfizer, Pottery Road, Dun Laoghaire, Final Issue No 1, January 2006.

6 Additional Assessment of TCE in Soil and Groundwater and QRA, Pfizer, Pottery Road, Dun Laoghaire, Final,

Issue No 3, February 2007.

7 Detailed Assessment of TCE in Groundwater, Pfizer Ireland Pharmaceuticals, Final, March 2008, Issue No.3.

8 Additional Characterisation of TCE in Soil and Groundwater – Pfizer Ireland Pharmaceuticals, Pottery Road,

Dun Laoghaire (URS, December 2009, reference 49341800).

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report also contained a summary of the proposed remediation strategy for the Site9, which

outlined Insitu Enhanced Bioremediation (ISEB) as the selected remedial technology. This

approach was agreed in principle by the EPA in May 2010.

A pilot study was undertaken in October 2009 to demonstrate the feasibility of the selected

ISEB remedial approach. The findings of the pilot study indicated that injection of carbon

substrate in the bedrock via injection wells is a feasible and effective approach.

4.3.3 Proposed Remediation

Following the successful pilot trial, a Full Scale Remedial Design and Implementation Work

Plan (RD&IMP) has been prepared for the Site10

. This Work Plan details how the remediation

will be implemented and is presented as follows:

(a) Site History;

(b) Remedial Standard & Remedial Objectives;

(c) Remedial Design & Implementation;

(d) Monitoring, assessment, and reporting program and frequencies; and

(e) Contingency actions.

The work plan identifies the following remedial actions to address the Chlorinated Aliphatic

Hydrocarbon (CAH) concentrations observed in groundwater and soil vapour at the Site:

• Perform remediation to reduce concentrations of TCE and its daughter products

through the most practical means available consistent with Best Available

Treatment principles.

• Focus the active remedial effort towards the area where most of the mass of CAH

contamination is considered to lie, and where the greatest reduction in

contaminant mass can potentially be achieved.

• Use a combination of active on-Site remediation and long term monitored natural

attenuation remediation to decrease TCE concentrations at the Site, using the

SSAC as long-term remedial targets.

• Continue both groundwater and soil vapour monitoring at the Site, through both

near term and long term monitoring programmes, to track biodegradation and

natural attenuation mechanisms that are occurring and maintain confidence that

9 Revised Remedial Proposal Summary – Appendix A to Additional Characterisation of TCE in Soil and

Groundwater – Pfizer Ireland Pharmaceuticals, Pottery Road, Dun Laoghaire (URS, December 2009, reference

49341800).

10 Full Scale Remedial Design and Implementation Work Plan, Pfizer Pottery Road, Dun Laoghaire, Co. Dublin,

(URS, February 2011)

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risk-based levels of constituents of concern in groundwater and soil vapour are

below acceptable limits.

The work plan also identifies contingency measures that would be performed, as necessary, if

groundwater or soil vapour monitoring detections are above the SSACs in the Site boundary

compliance wells.

The following monitoring programmes are proposed in the work plan:

The short term groundwater and soil vapour monitoring programme will commence four to six

weeks after the full scale injection event.

These monitoring events will continue on a quarterly basis to verify that the substrate has

been distributed throughout the treatment area and to measure the level of CAH degradation

that is occurring.

Once the Short Term Monitoring break point criteria (detailed in the work plan) have been met,

the long term monitoring programme will commence.

The long term monitoring program will consist of bi-annual monitoring events.

Reports will be issued on an annual basis describing the findings of the long-term monitoring

works. The Long Term monitoring programme (including wells sampled, monitoring frequency

and analytical parameters) will be reviewed with the EPA as required with a view to

decreasing either the number of wells sampled or frequency of sampling on the basis of

results in a given well.

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5. EXISTING ENVIRONMENTAL CONTROLS AT PIP

5.1 General

The PIP Dublin Sterile Products Facility at Dun Laoghaire is equipped with a high level of

environmental protection. Ongoing care for the environment is demonstrated by the

continuous upgrading of environmental protection systems/practices, and the continuous

reduction of plant emissions to the environment. It has a programme of continuous

improvement for a mature facility through training of people to maintain good

environmental practices and replacement, upgrading, retro-fitting, and as needed of

equipment to keep abreast of technological improvements.

5.2 Environmental Management

PIP operates an integrated approach to the management of environmental, health and

safety aspects of the site and Environmental Protection has always been a key

consideration. Since 1995, the site has operated under the IPC and IPPC licensing

system.

The management system undertakes regular monitoring of emissions to legal and

regulatory requirements and best practices. This environmental management system is

based on a combination of technical measures and documented environmental

management programmes and procedures, whose objectives are:

• Complying with all the requirements of the site’s IPPC licence,

• Eliminating the risk of accidental events which could give rise to significant

releases to the environment, and

• Ongoing continuous improvement of site environmental performance.

5.3 Releases to Atmosphere

Monitoring of emissions is undertaken for the site boilers and from the Fibrinolysin

process in accordance with IPPCL requirements. The licence also lists 23 minor emission

points and assigns specific emission limits for each of these minor emission points. Site

management is not required to monitor the minor emission points nor report monitoring

results to the EPA.

Emission point A2-1 has an activated carbon (charcoal) abatement system connected to

the Elase process equipment train. This is so as to remove Chloroform that may be

entrained in process air extraction. The adsorbent carbon is routinely checked for

saturation and replaced as required. The waste carbon is stored in a secure chemical

storage cabinet next to the pump house awaiting off-site disposal.

For further information on releases to air is detailed in Section 4.1.

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5.4 Releases to Surface Water and Groundwater

5.4.1 General

The surface water from each of the branches passes through an oil/water interceptor

before combining in the far south west corner of the site (near emission point SE1). The

interceptors are inspected weekly and drained by a contractor if significant oil/petroleum

contamination is identified.

The surface water is conveyed from the site in a dedicated surface drain system. There

are two main branches to the system:

1. The northern part of the site (relative to Plant North) serving mainly the

warehouse, PM2 and surrounding hard standing; and

2. The southern part of the site (relative to Plant north) serving the rest of the site.

All of the site clean surface water drain flow (default) passes through a monitoring

chamber via IPPC licensed emission point SW1. The surface water ultimately discharges

to the Deans Grange stream located approximately 100 m west of the site.

Once per week, a grab sample of the surface water is taken and tested for COD in an

external laboratory. In addition, the flow in the chamber is inspected daily for odour and

colour. Sample analysis data is reported annually to the EPA.

Surface water from the northern part of the site passes through a sub-surface surge tank

(volume 216,000 litres) and surface water from the southern part of the site through a

similar sub-surface tank located just in front of the Security Building (volume 460,000

litres). These surge tanks that there is no sudden surge of surface water to the receiving

Deans Grange stream.

The combined surface water flow passes through a monitoring chamber where the pH is

continuously monitored. If the pH steps outside the range pH 6.5 to 8.5, a diversion valve

automatically closes. The surface drain monitoring chamber then overflows to nearby

sub-surface re-enforced concrete surface water pump chamber (called the Fire Water

Collection Sump). From this sump, the collected surface water is pumped on level control

to one of the two 725 m3 above ground circular bolted steel firewater retention tanks

located at the south end of the site, the total retention volume being 1725 m3. Once

contained in these tanks, the collected surface water can be sampled and either pumped

to the process effluent balance tanks or off-site in contractor tankers.

The same surface water diversion procedure would be undertaken in the event of a fire

on the site. The previously mentioned diversion valve will also automatically close in the

event of either fire pump activation or on detection of flow through the sprinkler system.

The main potential sources of contamination of the surface water, soils and groundwater

are spills or leaks of raw materials, intermediates, final products, process wastes or fuels

from material and waste storage locations on site.

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Bulk storage tanks on site are located above ground and provided with concrete bunds to

contain any spills of leaks. The bunds are not connected to the surface water drainage

system. There are no underground tanks on site. Similarly chemicals and liquid wastes

are stored in 200 litre drums or smaller containers, located in designated bunded areas

within the plant. Site roads, truck unloading/loading yards and hard standing areas are

paved and rainfall run-off is collected into the surface water system.

The surface water discharged from the site is monitored continuously for pH by

monitoring equipment installed in the outfall chamber. Monitoring of surface water and

calibration of associated monitoring equipment is controlled by the site SOP EHS-201-06

IPPC Licence Compliance.

Process effluent from the different sources on site drains by gravity to a collection sump

from where it is pumped above-ground to the effluent balancing tanks. The effluent

balancing tanks control the effluent characteristics and flow volume to meet the IPPC

licensed limits. The effluent is balanced and neutralised if necessary using acid and

caustic dosing, prior to discharge. The final effluent sump is fitted with a pH monitor and

a refrigerated sampler. The process effluent is then combined with the sanitary effluent

and discharged to the Dun Laoghaire-Rathdown County Council sewer.

Operation of the effluent treatment system is automatically controlled by the Building

Management System (BMS). This system is alarmed for a series of events/parameters,

which indicates if there is a malfunction of operating equipment within the plant. In the

event of the occurrence of an alarm, this alarm is relayed to the site security gatehouse,

which is manned 24 hours a day. These alarms are then immediately relayed to members

of the EHS and Utility Departments upon occurrence, so that the operation of the plant

can be investigated.

5.5 Emergency Planning/Preparedness

PIP maintains an Emergency Response Procedure. Emergency Response Objectives,

Action Plans and Responsibilities are set down in the Procedure.

Detailed action plans are included in the procedure which specifies pre-planned

emergency response actions for several potential emergency situations. An Emergency

Planning Committee advises on the overall site strategy for handling emergencies, testing

the site capabilities and interfacing with local emergency services.

Emergency drills test the effectiveness of the plan and are carried out regularly. Desk top

exercises are also carried out regularly and various scenarios are presented to the

participants. A critique of the exercise is completed afterwards.

5.6 Prevention of Fire

5.6.1 Procedures

The plant Emergency Procedure specifies the action to be taken by employees on

discovering a fire. This includes, sounding fire alarms, evacuation requirements and

notifying the Dun Laoghaire Rathdown County Council Chief Fire Officer. Fire prevention

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is emphasised by audits, hot work permit restrictions and Fire Prevention Notices.

Operation instructions and Material Safety Data Sheets specify emergency response

requirements for fire or spill control.

5.6.2 Training

Fire training sessions are held regularly. The training covers practical fire extinguishers

operations, a review of plant emergency plans for handling fire situations and fire

prevention training. Fire evacuation drills are held regularly to familiarise employees with

evacuation requirements and that head counts are completed effectively.

5.6.3 Emergency Crew

The Emergency Response team provides assistance in dealing directly with the incident

and bringing the situation under control. The team is specifically trained in responding to

emergencies which may arise in PIP Dublin, the equipment available to deal with

incidents and the actions required to be taken.

5.6.4 Storage and Handling of Hazardous Materials

The plant has been designed and is operated in such a manner as to minimise the risk of

fire or explosion in the storage and handling of flammable materials. The nature of

manufacturing at the site is such that large scale bulk storage of chemicals is not

necessary. Flammable materials are confined to above ground storage tanks. Most of the

hazardous substances are both delivered to site, and stored on site, in various packaging

(primarily UN approved metal and plastic drums of varying volume, UN approved fibre

kegs and glass bottles). The site maintains Safety Data Sheets (SDSs) in an electronic

library and also in hard copies. The site has a licence for the storage and use of a

controlled substance, Ketamine, used for the production of Ketalar (a general

anaesthetic).

5.6.5 Management of Fire Safety

Measures are in place on the site to prevent fires and emergency situations and to

mitigate the effects of an incident. Specifically:

• Where required, buildings are sprinkler protected, i.e. in all areas where

flammable liquids are stored and handled such as the warehouse;

• There are fire hydrants located on the site in strategic locations;

• There is a comprehensive fire detection and alarm system throughout the site;

• Weekly checks are undertaken on various fire protection systems;

• There is a 1.6 million litre firewater/service water storage tank to the south of the

site;

• There are two emergency generators on the site;

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• There is 24 hour security on the site including night time and weekend Site

inspection rounds and security cameras placed in strategic locations; and

• Rated electrical equipment is in use and bonding and grounding of non-

conductive pipework and equipment in the process area reduces the risk of build-

up of static electricity.

In the event of a fire on site, there is the risk that the water used for fire fighting could

become contaminated with chemicals and that this contaminated water could drain into

the ground or, via the surface water system, into the Deans Grange stream. To mitigate

against the risk of this happening, a system has been provided for the containment of

water used for fire fighting. This system has the ability to retain up to 1,750 m3 of

contaminated firewater in dedicated above-ground firewater retention tanks (located to

the south of the site). This system operates by diverting all surface water to retention

tanks upon the initiation of the site fire-pumps.

6. SITE SPECIFIC ELRA

6.1 General

For facilities such as the Pottery Road plant, a detailed site specific ELRA is considered

appropriate.

The objectives of the ELRA are:

� To identify and quantify environmental liabilities at the facility focusing on:

unplanned, but possible and plausible events occurring during the

operational phase;

� To calculate the value of financial provisions required covering unknown

liabilities;

� To identify suitable financial instruments to cover each of the financial

provisions; and

� To provide a mechanism to encourage continuous environmental

improvement through the management of potential environmental risks.

The methodology includes a Risk Management Programme for the mitigation and

management of any environmental liabilities identified at this site. This programme is not

required for the calculation or implementation of a financial provision at a facility.

However, such a programme would encourage continuous environmental improvement

and the reduction of environmental liabilities.

The ELRA will cover environmental risks leading to a potential or anticipated liability.

Environmental risks will be deemed to cover all risks to: surface water, groundwater,

atmosphere, land and human health.

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6.2 Methodology-Risk Identification, Likelihood and Consequence

The following steps were undertaken as part of the site specific ELRA;

• Risk Identification

• Risk Classification (includes an Occurrence Assessment and a Severity

Assessment)

• Risk Evaluation

• Risk Prevention/Mitigation

6.2.1 Risk Identification

Risks where reviewed and updated on the site through:

1. What-if analysis - A suggested method of carrying out this process is to initially

identify all the ‘processes’ on site, list the hazards associated with each process,

identify potential causes of failure of the processes and analyze the effect

impacts on the environment.

Table 6.1 Example Hazard Identification Table

Risk ID Potential Hazard Environmental Effect

1 Describe scenario for occurrence

of potential liability e.g. spill of

solvent from solvent storage tank

Describe consequence

of proposed scenario

e.g. spill of solvent

goes to surface water.

6.2.2 Risk Classification-Occurrence Analysis

Having identified the potential risk, the likelihood of its occurrence needs to be assessed.

An analysis of historical data and existing environmental controls as outlined in previous

sections of this report was utilised when estimating likelihood of identified potential risks

occurring at PIP.

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The following table defines various likelihoods:

Table 6.2 Risk Classification Table-Occurrence

Rating

/Score

Category Description Likelihood

of

Occurrence

(%)

1 Very Low Very low chance of hazard occurring in 30 yr period 0-5

2 Low Low chance of hazard occurring in 30 yr period 5-10

3 Medium Medium chance of hazard occurring in 30 yr period 10-20

4 High High chance of hazard occurring in 30 yr period 20-50

5 Very High Very high chance of hazard occurring in 30 yr period >50

6.2.3 Risk Classification-Severity Assessment

Once the environmental impact had been identified one of the following consequences is

assigned.

Table 6.3 Risk Classification Table-Severity Criteria

Rating

/Score

Category Description Cost of

Remediation

(€)Note 1

1 Trivial No damage or negligible change to the

environment

<10,000

2 Minor Minor impact/localised or nuisance 10,000-100,000

3 Moderate Moderate damage to the environment 100,000-500,000

4 Major Severe damage to the environment 500,000-

1,000,000

5 Massive Massive damage to a large area, irreversible in

medium term

>1,000,000

Note 1 – Costs specific to PIP

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In order to determine an appropriate cost range for each of the Severity scores above,

the following aspects were considered:

• the sensitivity of the receiving environment;

• the anticipated damage that would realistically be expected to occur as a result

of an incident occurring at the site; and

• current anticipated costs associated with remediation and clean up of

environmental liabilities.

As per the EPA Guidance document, environmental risks will be deemed to cover all risks

to: surface water, groundwater, atmosphere, land and human health. In categorising the

severity of an event and therefore the cost of its remediation, one of the most significant

costs (i.e. the one which can prove most difficult to fix a maximum anticipated financial

provision) are costs associated with the remediation of effects on Human Health.

Based on the above considerations it is felt that the cost of remediation for the various

severity categories outlined in Table 6.3 are appropriate and specific to the Pfizer site on

Pottery Road.

Important: When categorising the Severity Rating relating to a risk, the severity rating

assigned must assume that all current mitigation measures in place have failed to prevent

the environmental discharge to the environment, e.g. if assigning an severity rating to a

failure in a storage tank resulting in contamination of surface water, the severity rating is

based on the assumption that the material contained in the storage tank has discharged

to surface waters, i.e. all mitigation measures employed to prevent that failure resulting in

contamination of surface water have failed, i.e. bund failure has occurred, surface water

diversion system, etc.

6.2.4 Risk Evaluation

Having identified the hazard and decided on its likelihood and severity the significance of

the risk is assigned. A risk score is determined by multiplying the occurrence score by the

severity score. The risk scores can be tabulated in a risk matrix.

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V. High 5

High 4

Medium 3

Low 2

Occurr

ence

V. Low 1

1 2 3 4 5

T

rivia

l

Min

or

Modera

te

Majo

r

Massiv

e

Severity

Where:

• Red – These are considered to be high-level risks requiring priority attention.

These risks have the potential to be catastrophic and as such should be

addressed quickly.

• Amber / Yellow – These are medium-level risks requiring action, but are not as

critical as a red coded risk.

• Green (light and dark green) – These are lowest-level risks and indicate a need

for continuing awareness and monitoring on a regular basis. Whilst they are

currently low or minor risks, some have the potential to increase to medium or

even high-level risks and must therefore be regularly monitored and if cost

effective mitigation can be carried out to reduce the risk even further this should

be pursued.

For all risks (‘high’, ‘medium’ or ‘low’) an insurance policy or other financial instrument

must be put in place to cover any liabilities.

With regard to ‘medium’ and ‘high’ risks the licensee must detail in the ELRA how these

risks will be made ‘acceptable’.

With regard to liabilities that are not covered by insurance, or other financial instrument,

the licensee must indicate how these liabilities will be underwritten in the future.

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6.2.5 Risk Prevention/Mitigation

Where appropriate, and particularly where risks may be in the Amber/Yellow or Red

zones in the Risk Matrix, mitigation measures are assigned to each risks and each Risk

Score is revised using post-mitigation severity and occurrence rankings. The risks are

then re-ranked and tabulated in the risk matrix to illustrate the overall degree of risk

reduction resulting from the risk mitigation measures. Where appropriate, the mitigation

measures are accepted for implementation. A Risk Management Programme is then

prepared which allocates a Risk owner for the ongoing management of risks and the

implementation of risk mitigation measures. Timeframes are also allocated for the

implementation of each risk mitigation measure.

6.3 Identification of Risks at PIP

The risk register has been updated based on observations gathered during the original

site visit along with URS’ extensive knowledge of the site and utilizing information

supplied by PIP, all of the ‘processes’ on site were identified. The hazards associated

with each process were listed and any potential causes of failure of the processes were

identified. If any effect to the environment could be perceived from the failure the effect

was analyzed and this became a Risk. A Risk Register was developed which contained

all the Risks identified on site.

Each process was considered separately and a ‘what if’ analysis was utilized to identify

all reasonable risks which were associated with the process in question. A list of risks

was developed and these were entered into a Risk Register. Table 6.4 illustrates the Risk

Register.

Table 6.4 PIP Risk Register

Risk

ID

Description

1 A spill occurring during the delivery and loading/unloading of bulk diesel oil

2 A spill in transferring diesel oil from bulk storage to Pump House fire pump tanks

3 A spill occurring during the delivery and loading/unloading of drummed virgin

chemicals and waste chemicals (e.g., organic non-chlorinated solvents or

chloroform)

4 A spill occurring during the delivery and loading or unloading of bulk acids or

caustic

5 A failure of one of the bulk diesel storage tanks

6 A failure of one of the bulk acid/caustic storage tanks

7 Loss of integrity of bunds surrounding the diesel tanks

8 Loss of integrity of bunds surrounding the caustic/acid tanks

9 Loss of integrity of storage yards where organic solvents are kept

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Risk

ID

Description

10 Loss of integrity of large external storage cabinets where chloroform and

chloroform contaminated waste is kept

11 Detection of additional TCE contamination on or off site

12 Detection of ground or groundwater contamination from other contaminants

13 Misclassification of waste.

14 Uncontrolled release of chloroform vapour to atmosphere.

15 Generation of fugitive emissions resulting in odour/air pollution.

16 Failure of effluent treatment system resulting in discharge of untreated effluent to

sewer.

17 Failure of underground process or foul drainage network including process or foul

sumps/lift stations resulting in leakage of material into soils and groundwater.

18 An on-site fire/explosion.

19 Spillage of large quantity of materials in production area during material transfer.

20 Release of ozone depleting or global warming substances to atmosphere.

21 Noise generation.

22 Loss of integrity of above ground pipelines conveying substances other than

water where not provided with secondary containment

These risks were assessed against the risk classification tables (RCTs) as provided in

Table 6.2 and 6.3. The risk classification table was designed to reflect the critical levels of

risk appropriate to the PIP site. Ratings, taken from a risk classification table, were

applied to the severity and chance of occurrence of each risk. Table 6.5 below illustrates

the assessment carried out for each risk in terms of its severity and likelihood of

occurrence.

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Table 6.5 Risk Assessment

Risk

ID

Risk Potential

Hazards

Environmental

Effect

Occurrence

Rating

Basis of Occurrence Severity

Rating

Basis of Severity

1 Spill during

the delivery

and

loading/un

loading of

bulk diesel

oil

Delivery tanker

overturning.

Leak from

delivery tank.

Overflow of

bulk storage

tank during

transfer.

Surface Water

Groundwater or

soil

Contamination.

1 Diesel fuel oil rarely delivered to site

(once every three to four years) since

only used as back up fuel and fire pump

testing.

Security control of deliveries.

Speed restrictions on site roadways

Well demarcated site access roadways

and well maintained.

Staff training in materials handling and

spill control techniques is provided. Spill

kits and SDS’s provided.

Loading and unloading takes place in

designated areas

Provision of a spill diversion and retention

system for storm drainage system

activated by control button and pH alarm.

Level indicators on diesel tanks.

Diesel tanks bunded to minimum 110%

Dedicated standard procedure for bulk

diesel delivery. unloading

4 A large diesel release to soil

or waters would entail

significant clean-up costs

(likely receptors Deans

Grange Stream or soil).

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Risk

ID

Risk Potential

Hazards

Environmental

Effect

Occurrence

Rating


Rating

Basis of Severity

2 A spill in

transferring

diesel oil

from bulk

storage to

Pump

House fire

pump tanks

Overflow of

pump house

storage tank

during

transfer.

Surface Water

Groundwater or

soil

Contamination.

2 1988 incident where diesel oil being

transferred to pump house tanks resulted

in release of diesel oil to Deans Grange

Stream.

Improved control of diesel transfer

procedure in place.



activated by control button and pH alarm

Drains from pump house isolated from

main storm drain and so now pump house

effectively internally bunded.

3 The 1988 incident costs not

large. Nonetheless,

significant clean-up

expenditure may be

expected in the event of a

release of diesel oil to

Deans Grange Stream.

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Risk

ID

Risk Potential

Hazards

Environmental

Effect

Occurrence

Rating


Rating

Basis of Severity

3 A spill

occurring

during the

delivery

and

loading/unl

oading of

drummed

virgin

chemicals

and waste

chemicals

(e.g.,

organic

non-

chlorinated

solvents or

chloroform)

Drum(s) fall

from delivery

truck.

Leak from

delivery tank.

Drum(s) fall

during transfer

from truck to

storage.

Drum(s) fall

during transfer

to/from areas

of usage.

Surface Water

Groundwater or

soil

Contamination

1 Chemicals,(mainly organic solvents,

cleaning agents and acids/bases)

delivered to site on a daily basis. Staff

training in materials handling and spill

control techniques is provided. Spill kits

and SDS’s provided.


Speed restrictions on site roadways.

ADR code applies for delivery, loading

and unloading of drummed chemicals.

Drums of solvents and chlorinated waste

shrink wrapped to pallets for

loading/unloading.

Trained forklift drivers.



Solvents including chloroform, delivered

in drums only.

Large scale bulk storage of solvents not

undertaken.




No recorded previous incidents

3 Based on worst case loss of

a 25 litre drum of

chloroform, migrating to

either Deans Grange

Stream via storm system or

to ground.

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Risk

ID

Risk Potential

Hazards

Environmental

Effect

Occurrence

Rating


Rating

Basis of Severity

4 A spill

occurring

during the

delivery

and loading

or

unloading

of bulk

acids or

caustic

Delivery tanker

overturning.

Leak from

delivery tank.

Overflow of

bulk storage

tank during

transfer.

Surface Water

Groundwater or

soil

Contamination.

2 One recorded incident in 30 years: -

delivery tanker arriving on site had a

small bottom outlet valve leak (caustic).

Swift emergency response resulting in

released caustic removed with no

adverse environmental impact.


Speed restrictions on site roadways






Loading and unloading takes place in

designated areas




Level indicators on storage tanks.

Storage tanks bunded to minimum 110%.

3 Based on worst case loss of

acids or caustic, migrating to

either Deans Grange

Stream via storm system or

to ground.

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Risk

ID

Risk Potential

Hazards

Environmental

Effect

Occurrence

Rating


Rating

Basis of Severity

5 A failure of

one of the

bulk diesel

storage

tanks

Rupture of

storage tank.

Pinhole leak.

Failure of

piping

attached to the

tank.

Surface Water

Groundwater or

soil

Contamination.

1 All bulk storage tanks are located within

bunded areas; retention capacity is at

least 110% of the largest tank.

Piping joints and valves for tank delivery

lines are within a bunded area.




No recorded failure of AST’s.

4 Currently, there are some

large volume bulk storage

tanks on-site. A large diesel

release to soil or waters

would entail significant

clean-up costs (likely

receptors Deans Grange

Stream or soil).

6 A failure of

one of the

bulk

acid/caustic

storage

tanks

Rupture of

storage tank.

Pinhole leak.

Failure of

piping

attached to the

tank.

Surface Water

Groundwater or

soil

Contamination.

1 All bulk storage tanks are located within

bunded areas; retention capacity is at

least 110% of the largest tanks.

Largest bulk storage tank (for acid &

caustic) is 2.3 m3

Piping joints and valves for tank delivery

lines are within a bunded area.




No recorded failure of AST’s.

3 The volume of acid or

caustic per tank is not very

large. Acid and caustic

contamination would not be

persistent. Nonetheless,

significant clean up costs

could be incurred in event of

larger volume loss (full tank

failure).

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Risk

ID

Risk Potential

Hazards

Environmental

Effect

Occurrence

Rating


Rating

Basis of Severity

7 Loss of

integrity of

bunds

surrounding

the diesel

tanks

Seepage of

spills into

underlying soil

or into external

storm drains

Surface Water

Groundwater or

soil

Contamination.

1 All diesel bunds are re-enforced concrete

and have recently passed the integrity

tests. Bunds are integrity tested every

three years and are visually inspected

weekly at the site. Any spill within the

bunds would be detected and cleaned up.

2 The assumption is that

limited contamination would

occur under two scenarios

(noting a total bund wall

collapse unlikely for re-

enforced concrete)::

1 - If, should a diesel tank

fail, the diesel contained

within the bund would be

pumped to safe temporary

storage, limiting volumes of

diesel to residual quantity

that could reach underlying

soil or external yard areas in

the event of a breach in

bund integrity.

2 – Any small releases, e.g,

a valve drip to water

accumulated in the bund,

could over time contaminate

underlying soil if bund

integrity is breached.

In both cases, the likely

contamination would be very

limited.

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Risk

ID

Risk Potential

Hazards

Environmental

Effect

Occurrence

Rating


Rating

Basis of Severity

8 Loss of

integrity of

bunds

surrounding

the acid or

caustic

tanks

Seepage of

spills into

underlying soil

or into external

storm drains

Surface Water

Groundwater or

soil

Contamination.

1 All caustic and acid bunds are re-

enforced concrete and have recently

passed the integrity tests. Bunds are

integrity tested every three years and are

visually inspected weekly at the site. Any

spill within the bunds would be detected

and cleaned up.

2 The assumption is that

limited contamination would

occur under two scenarios

(noting a total bund wall

collapse unlikely for re-

enforced concrete):

1 - If, should an acid or

caustic tank fail, the

released acid or caustic

contained within the bund

would be pumped to safe

temporary storage, limiting

volumes of diesel to residual

quantity that could reach

underlying soil or external

yard areas in the event of a

breach in bund integrity.

2 – Any small releases, e.g,

a valve drip to water

accumulated in the bund,

could over time contaminate

underlying soil if bund

integrity is breached.

In both cases, the likely

contamination would be very

limited.

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16 February 2011

Page 45

Final

Risk

ID

Risk Potential

Hazards

Environmental

Effect

Occurrence

Rating


Rating

Basis of Severity

9 Loss of

integrity of

storage

yards

where

organic

solvents

are kept

Seepage of

spills into

underlying soil

or into external

storm drains

(primarily

during

decanting of

organic

solvents from

UN 208 litre

drums)

Surface Water

Groundwater or

soil

Contamination.

1 Modern re-enforced concrete surface

resistant to chemical attack from

substances stored there.

Weather protection where the organic

solvent decanting station is located.

Yard inspected regularly.

Small quantities of organic solvents

managed in the yard




2 Considering the low

volumes of organic solvent

used in the yard, and the

fact that a very large

integrity breach any

releases would be limited.

10 Loss of

integrity of

large

external

storage

cabinets

where

chloroform

and

chloroform

contaminat

ed waste is

kept

Seepage of

spills into

underlying soil

or into external

storm drains.

Surface Water

Groundwater or

soil

Contamination.

1 Two storage cabinets - one containing

approximately 12 UN approved 10 litre drums

of Chloroform (used in production in PM1) and

the other containing approximately the same

volume in waste materials contaminated with

chloroform.

Cabinets are well maintained, modern and are

tested for integrity.

Yard and storage cabinets inspected

regularly.




3 Considering the volumes of

chloroform (120 litres), and

the fact that a very large

integrity may not result in

the total loss of all 12 drums

any releases would be

limited.

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Page 46

Final

Risk

ID

Risk Potential

Hazards

Environmental

Effect

Occurrence

Rating


Rating

Basis of Severity

11 Detection

of

additional

TCE

contaminati

on on or off

site

Human health

or

environmental

risk from

contact with

impacted

environmental

media.

Surface Water

Groundwater or

soil

Contamination.

Impact on

human health.

2 Detection of additional TCE

contamination on or off site is unlikely

considering the detailed investigations

undertaken to identify TCE contamination

from the site.

3 Should additional TCE

contamination be identified,

then the severity score is

based on an assumption

that the contamination would

be less then that detected to

date, coupled with what has

been concluded in

Quantitative Risk

Assessment.

12 Detection

of ground

or

groundwate

r

contaminati

on from

other

contaminan

ts

Human health

or

environmental

risk from

contact with

impacted

environmental

media.

Surface Water

Groundwater or

soil

Contamination.

2

The results of groundwater analysis

completed on the Pfizer site at Pottery

Road indicated a neutral pH and did not

indicate the presence of VOC

contamination.

Many soil and groundwater investigations

undertaken on the Pottery Road site.

There is a historical municipal landfill on

the site and some, albeit minor,

contamination related to the historical

landfill was observed during the pre-

construction phase in 2004 for the Aseptic

Project.

There are no recorded incidents of the

spill or release of chemicals not otherwise

described in this ELRA.

2 Considering the low

volumes of chemicals used

on the site, both currently

and historically, and, with

the exception of chloroform

and TCE, the relatively non-

persistent (in the

environment) properties of

chemicals used, any future

detected contamination is

likely to be limited.

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Page 47

Final

Risk

ID

Risk Potential

Hazards

Environmental

Effect

Occurrence

Rating


Rating

Basis of Severity

13 Misclassific

ation of

Waste

Improper

disposal of

waste.

Surface Water

Groundwater or

soil

Contamination.

Public Health

Risk if

hazardous

waste is

disposed of in

non-hazardous

manner.

1 All matters and records related to waste

management, are managed by conditions

and schedules contained in the IPPC

licence.

Designated Waste Storage Compound.

DGSA controls in place.

No known issues regarding waste

management.

No persistent pollutants likely in waste

transfers.

4 If a large quantity of waste

was incorrectly categorised,

it could result in significant

financial implications for PIP

14 Uncontrolle

d release of

chloroform

vapour to

atmosphere

Risk to human

health in

surrounding

area

Atmospheric

pollution.

2 There is currently effectively just one

Main Emission, A2-1, on building PM1,

serving the process where chloroform is

used.

There has been one historical ELV

exceedances regarding air emissions of

Chloroform.

Existing monitoring and control

techniques employed at the plant would

shut down the process causing the

emission

1 Unlikely that a large quantity

but severity assumes

material would be emitted.

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Page 48

Final

Risk

ID

Risk Potential

Hazards

Environmental

Effect

Occurrence

Rating


Rating

Basis of Severity

15 Generation

of fugitive

emissions

resulting in

odour/air

pollution

Risk to human

health in

surrounding

area and

odour

nuisance

Atmospheric

pollution

1 Air handling units in place and maintained

on a regular basis in relevant laboratories.

HEPA filtering of production areas.

Waste management system in place.

No biological treatment at the effluent

balancing tanks – pH neutralisation plant.

Fugitive emissions study completed which

concludes that no significant fugitive

emissions at Pfizer.

2 Impact would be limited to

the surrounding area.

Unlikely that a very strong

odour would result from

activities at Pfizer.

Not likely to result in any

significant unknown

liabilities. Odour would

eventually dissipate in the

environment. Not likely to

result in any significant

health effects.

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Page 49

Final

Risk

ID

Risk Potential

Hazards

Environmental

Effect

Occurrence

Rating


Rating

Basis of Severity

16 Failure of

effluent

treatment

system

resulting in

discharge of

untreated

effluent to

sewer.

Failure of on-

site

neutralisation

tank resulting

in discharge of

untreated

effluent to Dun

Laoghaire

Rathdown

Council Sewer

and

subsequent

release to sea.

Impact on

receiving local

authority

treatment plant

with knock-on

effects in

receiving waters

at Killiney Bay.

2 BMS system in place which raises an

alarm at security if the wastewater

comes within a specific range but

which is also within the IPPCL limit.

Security then notifies the EHS

Manager or Environmental Officer and

the Utility technician on duty who

respond immediately to the alarm.

The BMS is checked each business

day by engineering.

Environmentally critical equipment

related to the balancing system is

maintained on a weekly basis.

PIP Management can cease

discharging from effluent balancing

system if failure occurs.

Further treatment at the Dun

Laoghaire Rathdown Council Sewer

prior to release to sea.

There have been minor non-

compliances with effluent (pH and

flow) and one incident regarding

release of VFEND product (refer to

section 4.2.3)

2 Costs associated with

remediation if hazard

occurred.

Based on experience from

VFEND incident unlikely to

be any significant

environmental impact.

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Page 50

Final

Risk

ID

Risk Potential

Hazards

Environmental

Effect

Occurrence

Rating


Rating

Basis of Severity

17 Failure of

underground

process or

foul drainage

network

including

process or

foul

sumps/lift

stations

resulting in

leakage of

material into

soils and

groundwater

Seepage of

leaks into

underlying

soils and

groundwater.

Surface Water

Groundwater or

soil

Contamination.

2 As per the IPPCL, underground

pipelines are inspected every three

years. A drain integrity survey of

surface, foul and process underground

pipelines was completed in 2009.

Some minor defects in foul drainage

identified and repaired.

3 Severity is based mainly on

potential costs associated

with repair of undergrounds

drains & possible soil

remediation if major

discharge were to occur.

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Page 51

Final

Risk

ID

Risk Potential

Hazards

Environmental

Effect

Occurrence

Rating


Rating

Basis of Severity

18 An on-site

fire/explosion

.

Release of

toxic and

hazardous

material to

atmosphere,

surface water,

groundwater.

Atmospheric,

Surface Water

Groundwater or

soil

Contamination.

1 Comprehensive control systems and

maintenance programme in place to

minimise the risk of fire.

Comprehensive Emergency Response

Plan in place at the site.

All processes, equipment and

techniques used on site are in line with

up-to date manufacturing techniques

used in the industry.

Very high standard of fire protection

and detection at the site.

Surface waters would be diverted to

the firewater retention tank in the

event of fire– therefore contaminated

waters would be retained on site and

so there should be no costs

associated with surface water

remediation.

No known event has occurred on-site.

Good ATEX (explosion protection)

control.

Very small quantities of chemicals on

site with the potential to do significant

harm to the environment in any one

location on the site.

4 Severity costing based on

emissions to ground or

surface water in the event of

a failure to contain a large

volume of contaminated

firewater.

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Page 52

Final

Risk

ID

Risk Potential

Hazards

Environmental

Effect

Occurrence

Rating


Rating

Basis of Severity

19 Spillage of

large quantity

of materials

in production

area during

material

transfer.

Seepage of

spills into

underlying

soils and

groundwater.

Risk to human

health.

Surface Water

Groundwater or

soil

Contamination if

material migrates

outside

production areas

1 Floor drains are directed to the effluent

balancing system.


spill control techniques is provided.

Spill kits and MSDS’s provided.

No known incidents have occurred on-

site.

Emergency response procedure

accounts for environmental incidents,

including spills.

3 If large spill were to migrate

beyond existing containment

measures, it would result in

moderate damage to the

environment as moderate

volumes of hazardous/toxic

material could be contained

in production runs may be

released via surface water

drainage system to the

Dean Grange stream.

20 Release of

Ozone

Depleting or

global

warming

substances

to

atmosphere

Ozone

depletion

Atmospheric

pollution

2 HFCs and HCFCs in use on-site,

mainly in fridges, freezers, chillers,

HVAC units and freeze driers, are

tracked in accordance with site

specific procedures. Any loss of

HFCs/HCFCs from the systems are

recorded in a site register and these

figures are used to populate the

PRTR.

1 Negligible effect on the

ozone layer resulting from

PIP activities (102.5kg of

HFC were reported in the

AER for 2009 as losses

accidental losses from the

systems).

Localised impact – potential

health issues and costs

associated with repair of

refrigerant system

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Page 53

Final

Risk

ID

Risk Potential

Hazards

Environmental

Effect

Occurrence

Rating


Rating

Basis of Severity

21 Noise

Generation

Noise

disturbance in

the

surrounding

area

Noise Pollution 3 Engineering controls in place.

Acoustic louvers in place in

maintenance/utilities.

The pump house has been upgraded

so as to reduce noise levels being

emitted.

Noise survey is conducted annually in

accordance with the IPPCL.

New expansion design with

surrounding berms to lessen off-site

noise impact

2 Localised impact - nuisance

to locals

Costs associated with noise

reduction measures.

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Page 54

Final

Risk

ID

Risk Potential

Hazards

Environmental

Effect

Occurrence

Rating


Rating

Basis of Severity

22 Loss of

integrity of

above

ground

pipelines

conveying

substances

other than

water where

not provided

with

secondary

containment

Release of

toxic and

hazardous

material to

atmosphere,

surface water,

groundwater.

Surface Water

Groundwater or

Soil

Contamination.

Risk to human

health if

employees under

or near piperack

when failure

occurred.

1 No previous incidents of major pipe

rack failure. Major failure is unlikely to

occur unless an unlikely incident such

as collision with an item of plant on-

site was to occur.

The main pipe rack runs are from the

CUB to production and then only

carrying steam and water. There is no

bulk solvent storage on site and no

solvent pipelines on racks.

Some short runs of diesel pipeline and

caustic/acid/utility treatment chemicals

(at the CUB) exist over unmade

ground. Acid and caustic pipes also

run overground from the bulk storage

tanks to the PM2.

No recorded incidents relating to

release of chemicals from above

ground pipelines.

3 Severity based on costs

associated with clean up of

diesel should a leak from a

diesel pipeline above ground

not be identified. . Any

impact on soil, groundwater

or surface water would be

localised.

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Page 55

Final

6.4 Assessment of Risks at PIP

6.4.1 Risk Register

The risk register below ranks the risks in order of decreasing score to prioritise mitigation

and management measures.

Table 6.6 Risk Register ranked by Risk Score

Risk ID Description Occurrence

Rating

Severity

Rating

Risk Score

2 A spill in transferring diesel

oil from bulk storage to Pump

House fire pump tanks

2 3 6

4 A spill occurring during the

delivery and loading or

unloading of bulk acids or

caustic

2 3 6


contamination on or off site

2 3 6

17 Failure of underground

process or foul drainage

network including process or

foul sumps/lift stations

resulting in leakage of

material into soils and

groundwater.

2 3 6

21 Noise generation. 3 2 6


delivery and

loading/unloading of bulk

diesel oil

1 4 4

5 A failure of one of the bulk

diesel storage tanks

1 4 4

12 Detection of ground or

groundwater contamination

from other contaminants

2 2 4

13 Misclassification of waste. 1 4 4

16 Failure of effluent treatment

system resulting in discharge

of untreated effluent to

sewer.

2 2 4

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Page 56

Final


Rating

Severity

Rating

Risk Score

18 An on-site fire/explosion. 1 4 4


delivery and

loading/unloading of

drummed virgin chemicals

and waste chemicals (e.g.,

organic non-chlorinated

solvents or chloroform)

1 3 3


acid/caustic storage tanks

1 3 3

10 Loss of integrity of large

external storage cabinets

where chloroform and

chloroform contaminated

waste is kept

1 3 3

19 Spillage of large quantity of

materials in production area

during material transfer.

1 3 3

22 Loss of integrity of above

ground pipelines conveying

substances other than water

where not provided with

secondary containment

1 3 3

7 Loss of integrity of bunds

surrounding the diesel tanks

1 2 2


surrounding the caustic/acid

tanks

1 2 2

9 Loss of integrity of storage

yards where organic solvents

are kept

1 2 2

14 Uncontrolled release of

chloroform vapour to

atmosphere.

2 1 2

15 Generation of fugitive

emissions resulting in

odour/air pollution.

1 2 2

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Page 57

Final


Rating

Severity

Rating

Risk Score

20 Release of ozone depleting

or global warming

substances to atmosphere.

2 1 2

6.4.2 Risk Matrix

The risk matrix below indicates the critical nature of each risk. (Risk ID’s from the Risk

Register have been used to complete this matrix.)

Table 6.7 – Risk Matrix

V. High 5

High 4

Medium 3 21

Low 2 14, 20 12, 16 2, 4,

11, 17

Occurr

ence

V. Low 1 7, 8, 9,

15

3, 6, 10

19, 22

1, 5,

13, 18

1 2 3 4 5

Trivia

l

Min

or

Modera

te

Majo

r

Massiv

e

Severity

Where:

Red is a high level risk.

Yellow is a medium level risk.

Green (light and dark) is a low level risk.

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16 February 2011

Page 58

Final

Table 6.7 above indicates that there are currently no risks identified in the red zone or

yellow zones requiring priority attention. This is a result of existing environmental controls

in place at the site. All risks identified are located in the green zone (light and dark)

indicating that these are currently low risk. However, it is important to note that these

risks are considered low risk as a result of existing controls measures employed at the

site aimed at reducing/eliminating both the occurrence and where this is not possible the

severity of these risks. There is a need for continuing awareness and monitoring of these

risks on a regular basis.

6.5 Risk Prevention, Mitigation and Management

The risk assessment and categorisation phase identified no red or yellow zone risk, which

requires immediate action. All risk were classified in the as green zone risks. Current

measures to control these risks are considered adequate with No further control

measures considered necessary. However, these risks should be monitored on a regular

basis.

However, the green zone risks may have the potential to increase to yellow or red zone

risks, and where additional risk management measures are available to manage them at

their current levels or reduce them further, these should be implemented if considered

cost-effective.

6.5.1 Quantification of Unknown Environmental Liabilities

The costs associated with the known environmental liabilities (e.g. closure and aftercare

costs and on-site contamination) for the PIP facility was calculated through the

preparation and costing of the RMP (refer to Site Specific RMP prepared for PIP).

For the unknown liabilities identified in this report a financial model is necessary to

estimate the environmental liability associated with these risks.

Each Risk has two characteristics that are derived from the Risk Classification Tables

(See tables 6.2 and 6.3) that are used in the financial models:

• The range in probability (X-Y%) of the risk occurring

• The range in cost implications (€A-B) if the risk occurs

The requirements of the financial model must first be defined in terms of worst, most

likely or best case scenarios. If the model is for the worst case scenario, then the higher

end of each range is used in the calculations, if the model is for the most likely case then

the median of each range is used and similarly if the best case scenario is required then

the lower end of each range is used resulting in the lowest cost.

The simplest form of financial model can be based on simply multiplying the minimum,

median or maximum value of each range for each Risk (depending on the scenario

considered) and totaling the values for each Risk in the Register.

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Page 59

Final

For the PIP facility the worst case scenario was calculated. Table 6.8 illustrates how the

financial output for the worst case scenario is calculated.

From this, financial instruments for unknown liabilities can be selected as outlined in

Section 8 of this report.

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Page 60

Final

Table 6.8 - Worst Case Scenario Financial Model

Risk

ID

Potential Hazard Occurrence

Rating

Likelihood

of

Occurrence

Range (%)

Severity

Rating

Cost

Range (€)

Worst Case

Likelihood

(%)

Worst

Case

Severity

(€)

Worst Case

Cost (€) Note 1

- Site Closure. - -

- - - -

€1.13million

See note 2


delivery and loading/unloading of

bulk diesel oil

1

0 - 5

4 500,000 –

1,000,000 5 1,000,000 50,000

2 A spill in transferring diesel oil

from bulk storage to Pump

House fire pump tanks

2

5 - 10

3 100,000 –

500,000 10 500,000 50,000


delivery and loading/unloading of

drummed virgin chemicals and

waste chemicals (e.g., organic

non-chlorinated solvents or

chloroform)

1 0 - 5

3 100,000 –

500,000 5 500,000 25,000


delivery and loading or

unloading of bulk acids or

caustic

2 5 - 10

3 100,000 –

500,000 10 500,000 50,000

5 A failure of one of the bulk diesel

storage tanks

1 0 - 5

4 500,000 –

1,000,000 5 1,000,000 50,000

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Page 61

Final

Risk

ID


Rating

Likelihood

of

Occurrence

Range (%)

Severity

Rating

Cost

Range (€)

Worst Case

Likelihood

(%)

Worst

Case

Severity

(€)

Worst Case

Cost (€) Note 1


acid/caustic storage tanks

1 0 - 5

3 100,000 –

500,000 5 500,000 25,000


surrounding the diesel tanks

1 0 - 5

2 10,000 –

100,000 5 100,000 5,000


surrounding the caustic/acid

tanks

1 0 - 5

2 10,000 –

100,000 5 100,000 5,000

9 Loss of integrity of storage yards

where organic solvents are kept

1 0 - 5

2 10,000 –

100,000 5 100,000 5,000

10 Loss of integrity of large external

storage cabinets where

chloroform and chloroform

contaminated waste is kept

1 0 - 5

3 100,000 –

500,000 5 500,000 25,000


contamination on or off site

2 5 - 10

3 100,000 –

500,000 10 500,000 50,000

12 Detection of ground or

groundwater contamination from

other contaminants

2 5 - 10

2 10,000 –

100,000 10 100,000 10,000

13 Misclassification of waste. 1 0 - 5

4 500,000 –

1,000,000 5 1,000,000 50,000

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Page 62

Final

Risk

ID


Rating

Likelihood

of

Occurrence

Range (%)

Severity

Rating

Cost

Range (€)

Worst Case

Likelihood

(%)

Worst

Case

Severity

(€)

Worst Case

Cost (€) Note 1

14 Uncontrolled release of

chloroform vapour to

atmosphere.

2

5 - 10

1

<10,000 10 10,000 1,000

15 Generation of fugitive emissions

resulting in odour/air pollution.

1 0 - 5

2 10,000 –

100,000 5 100,000 5,000

16 Failure of effluent treatment

system resulting in discharge of

untreated effluent to sewer.

2 5 - 10

2 10,000 –

100,000 10 100,000 10,000

17 Failure of underground process

or foul drainage network

including process or foul

sumps/lift stations resulting in

leakage of material into soils and

groundwater.

2 5 - 10

3 100,000 –

500,000 10 500,000 50,000

18 An on-site fire/explosion. 1 0 - 5

4 500,000 –

1,000,000 5 1,000,000 50,000

19 Spillage of large quantity of

materials in production area

during material transfer.

1 0 - 5

3 100,000 –

500,000 5 500,000 25,000

20 Release of ozone depleting or

global warming substances to

atmosphere.

2 5 - 10

1 10,000 –

100,000 10 100,000 10,000

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Final

Risk

ID


Rating

Likelihood

of

Occurrence

Range (%)

Severity

Rating

Cost

Range (€)

Worst Case

Likelihood

(%)

Worst

Case

Severity

(€)

Worst Case

Cost (€) Note 1

21 Noise generation. 3 10 - 20

2 10,000 –

100,000 20 100,000 20,000

22 Loss of integrity of above ground

pipelines conveying substances

other than water where not

provided with secondary

containment

1 0 - 5

3

100,000 –

500,000 5 500,000 25,000

Total worst case cost of Unknown liabilities (excluding RMP costs, refer Note 2) 596,000

Note 1: The financial provision was estimated using the guidance document provided by the EPA. It is noted that this is an estimated cost potential

based on estimated probability of a risk occurring and estimated magnitude of any resulting environmental liability. It is the opinion of URS that

liabilities in excess of the total shown on the table above could conceivably occur and that consequently financial provision in excess of this figure

is maintained by the site.

Note 2: The costs associated with a closure of the facility are dealt with in the Residuals Management Plan (updated in February 2011) along with

details of the financial provisions in place to deal with this.

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Final

7. FINANCIAL PROVISIONS

In the preceding sections we have summarised the site sensitivity, known historic

environmental liabilities and the measures, both technical and managerial, currently in

place to eliminate/reduce the risk of new environmental liabilities arising.

It has been concluded that the site environmental and safety management system is

robust in terms of preventing the development of any new significant off-site

environmental liability.

In the following section, we discuss the financial provisions at the site and whether these

provisions are adequate to satisfactorily address the liabilities addressed in Section 6.

7.1 Current Financial Provisions

Pfizer Ireland Pharmaceuticals, Dun Laoghaire (Pfizer Dun Laoghaire) is a component

site of Pfizer Ireland Pharmaceuticals, which operates within the Pfizer Global Supply

(PGS) division of Pfizer Inc. PGS operates a global network of manufacturing sites,

including both bulk manufacture and final dosage formulation facilities, together with

logistics facilities, and technical support functions. The function of PGS within the Pfizer

Inc. organisation is to ensure the manufacture and supply of quality product to the

company for ultimate distribution to the marketplace.

Pfizer Inc., which is headquartered in New York, discovers, develops, manufactures and

markets leading prescription medicines and healthcare solutions, for humans and

animals. Pfizer Inc. has total consolidated assets of $212 billion (USD) as at 31

December 2009 and consolidated net income in excess of $8.6 billion (USD) for the

financial year ended 31 December 2009. The company is the world’s largest

pharmaceutical company and recorded global revenues of US$67.8 billion in 2010.

The Pfizer Dun Laoghaire site is a cost centre within PGS and is therefore centrally

funded from Pfizer headquarters in the US. The site operates to an agreed annual

budget which is set in advance and which is intended to cover projected expenditure

related to site operations for that financial year.

In common with many multinational companies, PIP 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.

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16 February 2011

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Final

The risks identified in the site-specific ELRA are most likely to arise from particular

discrete and essentially sudden incidents such as fire, explosion, spillage, equipment

failures, and process malfunctions. Such incidents would be detected by plant systems

and would therefore be known events. Any potential environmental damage or

contamination arising from such incidents would therefore be covered by the existing

insurance arrangements. The current level of indemnity is more than adequate to cover

the worst-case scenario financial model in the ELRA.

A discovery and confirmation of previously unknown environmental liabilities arising from

gradually operating causes would be characterised and the costs of remediation would be

estimated. Any required remediation would be funded centrally by Pfizer in a similar

manner to that for RMP-associated costs. A scope of remediation work would be defined

and developed, and a dossier then prepared for Pfizer central management. If approved,

central funding would be released to cover the defined work. The release of funds may

be structured as required to cover immediate and short-term activities, and if necessary,

funds may be released over more extended time periods to cover longer-term

requirements, for example over several years or as required.

On the assumption that the risks in the worst-case scenario financial model defined in the

site-specific ELRA, were to give rise exclusively to previously unknown environmental

liabilities to be discovered at a future time (which is highly unlikely), then it is considered

that the worst-case costs of these unknown liabilities would be adequately covered by

Pfizer central funding as described.

Pfizer reviews its insurance and financial arrangements on a regular basis for its ongoing

and continued adequacy. Any changes or updates to such arrangements shall be

described in ELRA reviews to be submitted to the Agency.

7.2 Assessment of Pfizer Financial Provision

The environmental liabilities identified and assessed in this report (refer to Section 6) are

in the main unforeseen or unanticipated events that could occur suddenly as a result of

an accident or failure of control systems. Other liabilities identified are the result of

gradual and unforeseen discharge consequent upon failure of control systems which may

result in a discharge to the environment such as leaking drains or undetected leaks in

piperack systems.

Having consideration for the worst-case costs calculated in Table 6.8, a comparison of

existing financial provisions presented in Section 7.1 above may be made with the type of

unknown liabilities identified at the site.

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Final

Table 7.1 – Assessment of Pfizer Financial Provision

Risk Type Existing Pfizer Financial

Provision

Comment

Immediate, sudden and

unforeseen discharge

consequent upon an

accident.

Pfizer Global Insurance Pfizer Insurance coverage

financially adequate to cover

any liabilities identified.

Gradual unforeseen

discharge consequent upon

failure of control systems.

Pfizer Central Funds This type of Financial

Provision is adequate to

cover any unknown liabilities

which may arise but which

may not be covered under

the existing Pfizer Global

insurance.

Closure Restoration and

Aftercare Liabilities

Pfizer Central Funds Pfizer have already used

this to decommission and

remediate other sites and

facilities and it is deemed an

adequate financial provision

instrument to cover the

associated costs.

Based on the assessment of the current financial provisions in place, it is considered

unlikely that Pfizer requires any additional financial provisions beyond those currently

employed by the site as detailed in Section 7.1.

A statement of Parent Company Financial Guarantee by Pfizer Inc., approved by the EPA

in January 2011, is presented in Appendix B.

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Final

8. LIMITATIONS

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

Pharmaceuticals in accordance with the Agreement under which our services were

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

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

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

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

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

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

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

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

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

the Report.

9. COPYRIGHT

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

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

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16 February 2011

Final

Appendix A - Site Plan

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FORMER

DEANS GRANGE STREAM(FLOW TO SOUTHEAST)

(CULVERTED)

Iveagh Court, 6-8 Harcourt Road, Dublin 2TEL +353 1 4155100 FAX +353 1 4155101

ENVIRONMENTAL LIABILITY RISK ASSESSMENT,POTTERY ROAD

PROJECT

CLIENT

DRAWING TITLE

DRAWN STATUS CHECKED APPROVED

SML FINAL SF SF/PHSCALE DRG NO.

DATE

AS SHOWN

FEB 2011

49340764/01

FIGURE 2SITE LAYOUT

PFIZER IRELAND PHARMACEUTICALS

PRIVATE AND CONFIDENTIAL

APPROXIMATE SCALE (m)

0 25 50 75 100

Pfizer Site Outlined in Red

True North

Plant North

(CURRENTLY A LANDSCAPE AREA

NOTES

PNTN

TN

PN

EARTHENBERMS

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16 February 2011

Final

Appendix B - Statement of Parent

Company Financial Guarantee

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Documents

Pfizer Ireland Pharmaceuticals, Environmental Liabilities ... · funding mechanism to cover the expected liability. The latter case applies usually to, for example, on-site landfill