Pfizer Ireland Pharmaceuticals Ringaskiddy API Plant ... Ireland Pharmaceuticals Ringaskiddy API Plant Environmental Liabilities Risk Assessment 2010 Review Pfizer Ireland Pharmaceuticals\49340718

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Pfizer Ireland Pharmaceuticals Ringaskiddy API Plant

Environmental Liabilities Risk Assessment 2010 Review

18 June 2010 Final

Issue No 1.2 49340718

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Pfizer Ireland Pharmaceuticals Ringaskiddy API Plant Environmental Liabilities Risk Assessment 2010 Review


18 June 2010

Final

Project Title: Pfizer Ireland Pharmaceuticals Ringaskiddy API Plant

Report Title: Environmental Liabilities Risk Assessment 2010 Review

Project No: 49340718

Report Ref:

Status: Final

Client Contact Name: Geraldine Rooney

Client Company Name: Pfizer Ireland Pharmaceuticals Ringaskiddy API Plant

Issued By: URS Ireland Ltd., Iveagh Court, 6-8 Harcourt Road, Dublin 2, Ireland

Document Production / Approval Record

Issue No: 4

Name Signature Date Position

Prepared by

John Grumley

18 June 2010 Environmental Engineer

Checked & Approved by

Peter Hassett

18 June 2010 Manager EHS Ireland

Document Revision Record

Issue No Date Details of Revisions

1 7 May 2010 Draft for Comment

1.1 31 May 2010 Final Draft for Comments

1.2 18 June 2010 Final Issue

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18 June 2010

Final

LIMITATION

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

Pharmaceuticals Ringaskiddy API Plant in accordance with the Agreement under which our services

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

included in this Report or any other services provided by us. This Report may not be relied upon by

any other party without the prior and express written agreement of URS. Unless otherwise stated in

this Report, the assessments made assume that the sites and facilities will continue to be used for

their current purpose without significant change. The conclusions and recommendations contained in

this Report are based upon information provided by others and upon the assumption that all relevant

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

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

Report.

Where assessments of works or costs required to reduce or mitigate any environmental liability

identified in this Report are made, such assessments are based upon the information available at the

time and are subject to further investigations or information which may become available. Costs may

therefore vary outside the ranges quoted. No allowance has been made for changes in prices or

exchange rates or changes in any other conditions which may result in price fluctuations in the future.

Where assessments of works or costs necessary to achieve compliance have been made these are

based upon measures which, in URS’s experience, could normally be negotiated with the relevant

authorities under present legislation and enforcement practice, assuming a pro-active and reasonable

approach by site management.

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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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 PFIZER .................................................................................................. 6

2.1. Site Location..................................................................................................................... 6 2.2. History of Pfizer ................................................................................................................ 6 2.3. Site and Process Description ........................................................................................... 7

3. SCREENING AND OPERATIONAL RISK ASSESSMENT ............................................ 9

3.1. General............................................................................................................................. 9 3.2. Complexity........................................................................................................................ 9 3.3. Environmental Sensitivity ............................................................................................... 10 3.4. Compliance Record........................................................................................................ 13 3.5. Risk Category................................................................................................................. 14

4. HISTORICAL ENVIRONMENTAL LIABILITIES ........................................................... 15

4.1. Releases to Air ............................................................................................................... 15

DESCRIPTION ............................................................................................................................ 15

4.2. Process Water and Surface Water Discharges ............................................................. 19

DESCRIPTION ............................................................................................................................ 20

4.3. Soil and Groundwater Quality ........................................................................................ 27

5. EXISTING ENVIRONMENTAL CONTROLS AT PFIZER............................................. 31

5.1. General........................................................................................................................... 31 5.2. Environmental Management .......................................................................................... 32 5.3. Releases to Atmosphere................................................................................................ 32 5.4. Releases to Surface Water and Groundwater ............................................................... 33 5.5. Emergency Planning/Preparedness............................................................................... 35 5.6. Prevention of Fire ........................................................................................................... 35 5.7. Hazard Studies............................................................................................................... 36

6. SITE SPECIFIC ELRA ASSESSMENT......................................................................... 38

6.1. General........................................................................................................................... 38 6.2. Methodology – Risk Identification, Likelihood and Consequence.................................. 38

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CONTENTS

Section Page No

6.3. Identification of Risks at Pfizer ....................................................................................... 42 6.4. Assessment of Risks at Pfizer........................................................................................ 56 6.5. Risk Prevention, Mitigation and Management ............................................................... 58

7. FINANCIAL PROVISIONS ............................................................................................ 67

7.1. Current Financial Provisions .......................................................................................... 67 7.2. Assessment of Pfizer Financial Provision ...................................................................... 70

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1. INTRODUCTION

1.1. General

Pfizer Ireland Pharmaceuticals Ringaskiddy API plant (Pfizer Ringaskiddy),is a large

scale multipurpose manufacturer of new and existing active pharmaceutical ingredients

and their intermediates, in Ringaskiddy Co. Cork comprising three main production

buildings, one active pharmaceutical ingredient milling plant, associated site utilities and

storage facilities.

Environmental management of the site is regulated by the conditions prescribed in the

site IPPC Licence Register No. P0013-04. Licence P0013-04 was amended twice,

Technical Amendment A dated 23 May 2007 and Technical Amendment B dated 05th

February 2009.

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. 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 most recent EPA Guidance Document entitled “Guidance on Environmental Liability

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.

This is the first 3-year period review of the ELRA as per Condition 12.3.2 above,

incorporating the original information used to prepare the original ELRA and more recent

information on site activities since 2007. This ELRA replaces the original ELRA dated 19

February 2007 (Issue 4).

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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 being associated with a

quantifiable financial cost.

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

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

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

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

waste materials. For a site subject to IPC/IPPC Licensing, regular emissions to air, water

and land has typically been the subject of detailed quantification and consequence

analysis, i.e. assessment of the impact of emissions, during the licence application

process. The resulting IPC/IPPC licence either establishes emission limits and other

conditions at a level which prevents the arising of new liabilities, or which may require

bonding or other secure funding mechanism to cover any expected liability.

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

events may be loosely classified under the following headings:

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

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

incident or shortly thereafter;

• Events, 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. The degree to

which existing insurance policies cover environmental liabilities depends on many factors

including the specific wording of the policies and legal precedence. Most Public Liability

insurance policies will contain some element of cover for environmental liabilities.

However, the extent and applicability of coverage is dependent on analysis of and

professional judgement on the particular insurance policy.

The 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.

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1.3. Basis for the ELRA

The basis of this revised 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, including processes

and services;

� A review of the following documentation supplied by Pfizer:

- IPPC Licence Application Files;

- Site audit report following site audit conducted by the EPA in February

2010;

- Annual Environmental Reports for 2008 and 2009;

- Environmental Impact Statement prepared in June 1998 for the OSP4

facility;

- Bund Integrity Reports for 2009;

- Incident Report Forms for 2007, 2008 and 2009; and

- Residuals Management Plan for 2009.

� Publicly available information from the EPA.

� Site visit carried out on 22nd

February 2010 involving discussions with key Pfizer

personnel and a walk-through inspection of the facility and site;

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

and wastes generated; and

� Consideration of historic environmental incidents and remediation works

undertaken.

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

and other relevant personnel, and a site inspection, 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 Pfizer maintains site conditions in accordance with its IPPC

Licence No. P0013-04, Greenhouse Gas Permit No. IE-GHG025-04, GMM

Consent GMO Register No: 256-02 and its ISO 14001 accredited Environmental

Management System (EMS). No provision has been made for costs associated

with any criminal proceedings that could arise, as firstly, it is understood that

there is goodwill and a strong desire by Pfizer to remain compliant with relevant

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18 June 2010

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legislation and EPA requirements, and secondly, such costs are uninsurable and

therefore cannot be underwritten by any third party or insurance organisation.

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

does not consider potential environmental liabilities associated with significant

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

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

separate risk assessment exercise should they arise. Furthermore, the ELRA

does not include a costing of the decommissioning and oversight of the facility in

the event of a full site closure as this is set out in the Residuals Management

Plan, specifically catered for under Condition 10 of the IPPC Licence Reg. No.

P0013-04.

1.5. Structure of the ELRA

The ELRA report is structured as follows:

Section 2 provides an overview of the Pfizer facility including details of existing

processes, 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 Pfizer 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 describes the site specific risk assessment, which was carried out for the

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

Assessment, Risk Evaluation and Prevention/Mitigation.

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

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

associated with the facility.

Section 8 provides a summary and conclusion.

1.6. Limitations

URS has prepared this report for the sole use of Pfizer 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.

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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 PFIZER

2.1. Site Location

Pfizer Ringaskiddy operates a pharmaceutical production facility located in Ballintaggart,

Ringaskiddy, Co. Cork. The entire landholding comprises approximately 84 hectares on

the southern shore of Monkstown Creek in Cork Harbour, the parcel of land to the west of

the Pfizer Biotechnology Ireland facility is currently used for leisure, recreational and

agricultural purposes. Current Pfizer Ringaskiddy manufacturing operations occur on the

parcel of land to the east of the Pfizer Biotechnology Ireland facility and comprise

approximately 21 hectares. A site location map is shown in Figure 1.

2.2. History of Pfizer

The parcel of land which is now Pfizer Ringaskiddy was a Greenfield site until 1969 when

construction work on the Pfizer plant began. Pfizer began citric acid production at the site

in 1971. Pharmaceutical production at Ringaskiddy commenced in 1972.

Since then there has been ongoing development of the plant with the construction of new

buildings and the expansion of existing buildings, upgrading of facilities and the addition

of new facilities. Three major expansion projects completed in 1984, 1994, and 2001

added significantly to the pharmaceutical production capacity.

The citric acid business was sold to Archer Daniels Midlands (ADM) in 1990. In 2005,

ADM ceased production. The site was decommissioned and dismantled by Corrin MDA.

The IPPC licence for the site P0053-01 which was held by Corrin MDA, was surrendered

in September 2007, following completion of the site decommissioning and a successful

exit audit carried out by the EPA. Subsequently Pfizer has completed the construction of

a Small Scale Biologics Facility operated by Pfizer Biotechnology Ireland (PBI). The PBI

facility is separate from the existing Pfizer Ringaskiddy site and is operated under a

separate IPPC licence, P0864-01. Therefore it does not form part of the scope of this

current ELRA.

Pfizer Ringaskiddy API Plant was first issued with an Integrated Pollution Control (IPC)

Licence, Register Number P0013-01 (formerly 13), in 1995. This was revised to IPC

Licence Register Number P0013-02 (formerly 370) in 1998 to allow for the operation of a

new milling facility on site. This was further revised to IPC Licence Register Number

P0013-03 (formerly 542) in 2000 to allow for the operation of a new organic synthesis

plant, OSP4. The current IPPC licence P0013-04 was issued to the site in 2006 to allow

the acceptance of solvent wastes from other Pfizer Ireland sites for recovery in the

facilities available on the Pfizer Ringaskiddy site. Since 2006 there have been two

technical amendments to the IPPC licence as follows:

Technical Amendment A issued in May 2007, to accommodate a site boundary

adjustment; and

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Technical Amendment B issued in February 2009, to accept waste effluent from the

neighbouring Pfizer Biotechnology Ireland facility for treatment in the Ringaskiddy API

WWTP.

Towards the end of 2007 Pfizer Ringaskiddy ceased manufacturing activities in OSP2 as

part of a business rationalisation plan to eliminate excess production capacity. The

physical building infrastructure has been retained pending future decisions as to its

potential use. The building remains part of the Pfizer Ringaskiddy API site.

2.3. Site and Process Description

The Pfizer facility, manufactures active pharmaceutical ingredients by organic synthesis

on a campaign, batch basis from raw materials sourced throughout the world for transfer

to other Pfizer facilities for formulation and distribution. The products manufactured vary

according to market demand. Multi-purpose, batch production facilities have been

provided so that the facility has the flexibility to manufacture a range of products.

There are approximately 465 permanent personnel currently employed at the

Ringaskiddy site. The facility operates on a twenty-four hour, 7 days per week shift basis.

Raw materials, many of which are solvent based, come from many countries, from both

within and outside the European Union, whilst products are transferred to other Pfizer

distribution points and facilities throughout the world for formulation and consequent

supply to the marketplace. Products are manufactured by organic synthesis in campaigns

of variable length using batch processing operations.

The production part of the site is approximately 21 hectares in total area. The main

features of the production operation are summarised as follows:

• Organic Synthesis Plant (OSP) 1 including OSP1 hydrogenation building;

• OSP 2 including OSP2 hydrogenation building (decommissioned);

• OSP 3 including OSP3 hydrogenation building;

• OSP 4 including OSP4 hydrogenation building;

• Active pharmaceutical ingredient milling facility;

• Solvent recovery;

• Tank farms;

• Wastewater treatment plant;

• Laboratories including a kilo technology laboratory (KTL). The KTL laboratory is part

of the Process Development Centre (PDC) which commenced operation mid 2009.

This laboratory was relocated from Pfizer Loughbeg API site as a result of the

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divestiture of the Loughbeg site. The purpose of the small scale facility is to improve

and optimise process efficiencies. A GMM Consent [GMO Register No: 256-02] was

obtained for the use of GMO material in this facility. However, no GMM’s have yet

been used or stored in the facility.

• Warehousing (raw materials, intermediates, finished goods);

• Drum pad (materials storage area);

• Site services including nitrogen plant, steam, de-ionised water, compressed air,

refrigeration etc.

• Engineering office building;

• Maintenance workshop;

• Administration buildings;

• Contractor compounds; and

• Canteen.

The layout for the site is illustrated in Figure 2.

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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

Significant work has been done by the Environment Agency (England and Wales) in the

development of the Environmental Protection Operator and Pollution Risk Appraisal (EP

OPRA) methodology for classifying activities, and a similar but shortened version of this

methodology has been developed for this process. Complexity Bands have where

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available, been derived from similar classification in the EP OPRA Complexity Score. A

look up table for Irish activities has been included in Appendix B of the EPA’s ELRA

Guidance Document 2006.

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 August 2006, Pfizer was granted a revised IPPC Licence Registration No. P0013-04,

under Class 5.16 and 11.1.

The relevant complexity band for Pfizer according to the EPA’s ELRA Guidance

Document 2006 is as follows:

Pfizer is classed under section 5.16:

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

pharmaceutical products,

As Pfizer produces approximately 450 – 700 tonnes of product and intermediate each

year, it is therefore rated as G3 and receives a score of 3 according to the ELRA

complexity banding.

Pfizer is also classed under 11.1:

11.1 The recovery or disposal of waste in a facility, within the meaning of the Act of 1996,

which facility is connected or associated with another activity specified in this

schedule in respect of which a licence or revised licence under part IV is in force or

in respect of which a licence under this said part is or will be required.

The Ringaskiddy site has facilities for the recovery of solvents from waste streams which

it uses to recover a large proportion of the solvents used onsite. Pfizer extended the

solvent recovery activities at the Ringaskiddy site to include the recovery of solvent from

other Pfizer sites in Ireland. This activity is considered to attract a G3 rating and therefore

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

According to the EPA ELRA Guidance Document 2006, where one or more scheduled

activities is carried out at a site, then the highest complexity band is applied. In this

instance both activities receive the same complexity band and therefore a complexity

band of G3 is applied to the site.

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

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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 Beings

� Groundwater

� Surface Water

� Air Quality

� Protected Ecological Sites

� Sensitive Agricultural Receptors

Table 3.1 Environmental Sensitivity Classification

Total Environmental Attribute Score Environmental Sensitivity Classification

Low <7 1

Moderate 7-12 2

High >12 3

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Table 3.2 - Environmental Sensitivity Sub-Matrix

Environmental Attribute Environmental Attribute Score

Notes

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

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

Protected Ecological Sites Note 3

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 Pfizer facility is underlined and bold. Note 2 – The scoring system used is taken from the EPA ELRA Guidance Document 2006. Note 3 – Monkstown Creek is a proposed Natural Heritage Area

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Based on the above Environmental Sensitivity Sub-Matrix, the total environmental

attribute score for Pfizer is 7 which indicate 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.

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

compliance was examined. This documentation review demonstrated that Pfizer have a

good record of compliance with the conditions outlined in the IPPC Licence. The

reportable incidences over the past three years which have occurred at the site were also

dealt with in a proactive manner and no residuals are expected as a result of any of these

incidents. Pfizer have received only a limited number of complaints over the last five

years and all were dealt with in a prompt and proactive manner. In a substantial number

of cases, investigations into the complaints received were found not to be as a result of

site activities. Pfizer Ringaskiddy has never been convicted under the Environmental

Protection Agency Act or any other environmental legislation.

In relation to existing ground contamination at the site, there exists residual shallow

groundwater contamination primarily associated with losses of solvent from a former

underground tank farm. Underground storage tanks were removed and replaced with

contained above-ground vessels, and associated excavated soils were remediated. A

series of recovery wells were installed to extract contaminated groundwater in the source

area. The recovery wells operated for several years and succeeded in significantly

reducing the level of residual contamination, to the extent that the wells could then cease

operation. The site continues to operate containment wells which provide full hydraulic

containment from the source area. The containment wells prevent migration of any

contaminated groundwater from the site and pump this groundwater to the site

wastewater treatment plant.

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Groundwater quality and the associated groundwater management programme are both

monitored and evaluated biannually.

The site maintains a good compliance history with regard to their IPPC Licence and the

remaining groundwater contamination is minor. A compliance record score of 3 is judged

appropriate for Pfizer.

3.5. Risk Category

The preceding subsection of this report has determined the:

Complexity Score (G3) = 3

Environmental Sensitivity Score = 2

Compliance Record Score = 3

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 18,

which according to table 3.3 below indicates that Risk Category 2 is applicable to the

Pfizer Site.

Table 3.3 – Risk Category

Risk Category Total Score

Category 1 <5

Category 2 5-23

Category 3 >23

The Pfizer site is classified in Risk Category 2 and therefore the guidance provided in the

EPA ELRA Guidance Document 2006 for such 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;

� Significant accidental releases of hazardous gases.

In total there are currently 43 main emissions points, approved for use with specified

emission limit values, outlined in the current licence Reg No. P0013-04. The number of

approved emission points has increased in a phased manner as the production facilities

have expanded at the site, and some of those approved remain to be installed for future

use. A majority of emission points relate to vents from specific equipment items including

mills and some down flow booths. The key major emission points are associated with the

abatement of Volatile Organic Carbons. Two of the manufacturing facilities onsite, OSP1

and OSP3, have dedicated VOC Absorption Plants installed as the main VOC abatement

systems. VOC emissions from the OSP4 manufacturing facility are abated by a

dedicated flameless thermal oxidiser as the main abatement system.

Emissions to air from the site have been subject to various conditions and emission limit

values (ELVs) set out in the various IPC and IPPC licences granted for the site since

1995. Prior to the implementation of IPC Licensing, existing emission points at the time

were covered by licences under the Air Pollution Act and subject to monitoring for several

years previously.

A review of the historical documentation relating to these emissions was undertaken as

part of this ELRA.

The abatement systems on emissions to atmosphere from OSP1 and OSP3 are typically

designed to achieve TA Luft 1986 levels, with minor polishing modifications to further

achieve the 1997 reclassification for certain materials, and the VOC Absorption Plants

installed on each of these facilities have maintained good compliance histories.

Continuous FID monitors are installed on each VOC plant stack, and readings are

displayed on the computer control system in each plant. Elevated emissions will

generate audible alarms on the control system at conservative settings, allowing early

and preventative actions to be taken to minimise emissions and maintain compliance.

A review of the incidents reported to the EPA and level of compliance with the ELVs

outlined in the sites IPPC licence was undertaken for the previous three years (2007,

2008 and 2009). Three non-compliances were noted in addition to a number of monitor

malfunctions, details are as follows:

Date Description Corrective Action

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16.01.2007 During a routine inspection, laboratory personnel observed a

partially loose connection on the sampling line entering the

continuous emissions monitor serving V2. The connection

was fully reinstated immediately. A review of monitoring and

service records confirms that the issue arose during

scheduled maintenance work which had been conducted on

the instrument on 11-Jan-07 by an external service company

Sampling line was

immediately fully re-instated

following observation.

29.01.2007 On Sunday 28-Jan-2007 a malfunction was detected on the

continuous monitor unit on V13. The vendor company serving

the unit was contacted and an engineer came onsite to

investigate. The malfunction was traced to an electronic fault

which had developed on a digital input/output card. The

vendor company implemented a wiring and software change

on the monitoring unit to allow it to continue functioning

pending further repair the following day. As a result of this

work, emissions readings from the monitor during the period

ca. 0600 hours 28-Jan-2007 through ca. 1500 hours 29-Jan-

2007 were recorded without correction to standard conditions

of temperature, pressure, oxygen, moisture. The emissions

readings during that time were therefore recorded under stack

conditions rather than standard conditions. Readings were in

the normal expected operating ranges and no elevated

readings were noted. Further work was carried out by the

vendor on 29-Jan-2007 to restore the data correction feature

and a follow-up inspection by laboratory personnel was

conducted as part of routine checks, to ensure that data

recording, including correction to standard conditions, were

functioning properly. The thermatrix unit was unaffected by

this fault and functioned normally

Re-wiring and software

modification work on 28-Jan-

2007 allowed an interim

repair to the unit. Further

follow-up work on 29-Jan-

2007 re-instated the

correction feature and full

functionality was restored.

The unit was allowed to run

normally overnight. An

inspection of data recording

was performed by laboratory

personnel as part of daily

checks on 30-Jan-2007 and

data recording was

confirmed as operating

normally.

02.12.07 During the half-hour period between 15:00 – 15:30 hrs on 02-

December-2007, the FID continuous emissions monitor

serving V5 recorded a 30-minute mean VOC reading of

3.6kg/hr.

All processing ceased immediately upon detection of elevated

emissions. It was not possible to take a regulatory 30 minute

bag sample at the time, however based on the processes that

were running in the plant at that time the emissions were likely

to have been predominantly t-butanol and isobutylene (TA Luft

classifications: Class III).

The preceding half-hour VOC reading recorded by the

continuous monitor was 0.2 kg/h and following intervention by

plant personnel, continuous VOC emissions dropped to <0.2

kg/h within a one-hour period. The source of this isolated

event was most likely due to the generation of a non-

condensable gas, isobutylene (boiling point: -7 degC), in the

vent header system. Isobutylene is generated from t-butanol,

when present in an acidic environment.

Operational procedures

were put in place on the

plant to prevent/ mitigate this

issue from re-occurring. It is

also intended to install a

carbon-bed system in 2008,

as an ancillary process step

to the existing VOC

absorption plant. This serve

as a polishing step to

abate/remove VOCs with

low-boiling points.

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04.02.08 The continuous VOC analyser monitoring emissions to

atmosphere from vent V5 (OSP3) registered intermittent

malfunction events during the approximate period 02:30-08:00

hours on Saturday 02-February-2008. The analyser resumed

normal monitoring at approximately 08:00 hours that day.

The OSP3 VOC Absorption Plant operated normally

throughout the period of the analyser malfunction.

The analyser was subjected

to a full inspection on

Monday 04-February-2008

by the vendor company

which services and

maintains the unit, and was

confirmed as operating

normally. The performance

of the analyser was

monitored closely over

subsequent days to ensure

that it continued to function

correctly.

29.05.08 On 28-May-2008, at 10.00 hours, a malfunction was detected

on the continuous emissions monitoring system serving V13 in

OSP4 which resulted from the failure of an analogue output

card in the system electronics. This led to a shutdown of the

continuous emissions monitoring system.

The vendor company

serving the unit was

contacted and an engineer

attended onsite.

A new analogue output card

was fitted and the

continuous emissions

monitors serving V13 were

brought back on line at

17.30 hours.

22.07.2008 Elevated readings on the continuous VOC monitor were

recorded at vent V3 (OSP1) during pre-checks for a

production campaign

Processing within the OSP1

facility initiated a shutdown

upon alarm detection of the

elevated readings

A sample control point has

been implemented into the

process to ensure that

methanol is effectively

removed from the reflux

vessel prior to addition of

hydrochloric acid and

subsequent reflux.

An air dispersion model of

the recorded emission was

conducted by independent

consultants. The results

confirmed that the recorded

emissions had no significant

impact on ambient air

quality.

03.10.2008 The continuous emissions monitor serving V13 recorded

elevated 30-minute mean readings for the following

A low gas flow interlock was

installed within the system

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18 June 2010

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parameters CO, TOC and HCl respectively. which triggers a complete

system shutdown when an

unexpectedly low flowrate of

natural gas is detected into

the oxidiser bed.

An air dispersion model of

the recorded emission was

conducted by independent

consultants. The results

confirmed that the recorded

emissions had no significant

impact on ambient air

quality.

26.06.2010 The continuous emissions monitor, recorded elevated

30 minute mean readings. Immediately on detection of

the readings, personnel commenced safe cessation of

processing.

Fume generated from processing in OSP4 is constantly

monitored using LFL meters and is combined with the

fume volumetric flowrate to calculate the fuel loading to

the thermal oxidiser. Depending on the fuel loading,

natural gas is supplied to the oxidation bed to maintain

an operating enthalpy set-point.

Investigations confirmed that hydrogen gas was evolved

from a neutralisation process and generated a false

high fuel indication (,i.e. high LFL). This resulted in

reduced gas flow to the thermal oxidiser bed and

consequently in reduced temperatures within the bed.

The elevated emissions readings therefore resulted

from incomplete combustion of natural gas within the

oxidiser bed at a time when the thermal oxidiser had

remained in run mode.

Processing activity within the

plant was halted and

systems isolated. The

observed increase in

emissions readings was

therefore unrelated to

processing activity within

OSP4 and resulted from the

incomplete combustion of

natural gas at a time when

the thermal oxidiser has

remained in run mode.

The thermal oxidiser system

was shutdown (disengaged

from run mode) and

subsequently re-started to

re-establish the normal

temperature profile.

Following detailed

investigation, a new interlock

was implemented which

would trigger a shutdown of

the thermal oxidiser system

(disengaging thermal

oxidiser from run mode) if

the temperature at the exit of

the oxidation bed decreases

below a set-point value.

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.

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4.2. Process Water and Surface Water Discharges

Currently, there is one treated process wastewater emission to sewer (Ref Point TE1)

from the Pfizer site which discharges to the local authority sewer at Warrens crossroads.

There are no direct discharges of process wastewater to surface waters from the site.

Surface water runoff from the site is collected via surface water collection lines, which

combine and discharge to Cork Harbour via a single outfall located at the north east of

the site.

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.

Prior to 1989, selected wastewaters arising from citric acid production and selected

streams from existing OSP buildings were disposed of at sea. In 1989, a wastewater

treatment plant (WWTP) was installed to treat the effluent produced from these facilities

as disposal of waste to sea was being phased out over subsequent years through

commitments under the Paris/Oslo Conventions. Disposal of wastewater materials via

sea dumping was common practice during these times for various types of wastewater

streams and sludge’s. The practice of sea disposal is not expected to have resulted in

any liabilities for Pfizer.

In 1990, the citric acid manufacturing facility on the site was divested to ADM. Ownership

of the WWTP was also acquired by ADM. Under an interim agreement, wastewater from

the OSP plants on the remaining Pfizer site was pumped to a dedicated treatment basin

in the ADM WWTP, and the combined treated effluent was discharged to Cork Harbour at

the local Ballybricken Outfall.

Upon divestiture of citric acid manufacturing to ADM, the remaining Pfizer site undertook

the design and construction of its own dedicated WWTP for the treatment of wastewater

at the site. The new WWTP began the commissioning process in November 1993 and

entered into full service shortly thereafter. Treated wastewater from the Pfizer WWTP is

discharged into the main local authority (Cork County Council - CCC) sewer serving the

local area. The Pfizer treated effluent joins the CCC sewer at Warrens Crossroads. The

CCC sewer ultimately discharges into Cork Harbour at Dognose Bank via the marine

outfall originally constructed by the IDA and now operated by CCC.

The Pfizer WWTP was further upgraded in a project spanning the late 1990’s to

accommodate anticipated increased wastewater loads resulting from the construction of

the OSP4 facility. Part of the WWTP upgrade involved reclamation of an area of

foreshore in order to provide for the relocation of stormwater holding facilities.

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Assessment of the impacts of the discharges from the WWTP on the receiving waters

were carried out as part of both the Environmental Impact Statement prepared for the

WWTP and in the various IPC/IPPC Licence Applications carried out for the site. The

discharge and discharge standards were found to be acceptable and no significant

impact on the quality of the receiving waters was envisaged.

In February 2009, the EPA issued Technical Amendment B to accept waste effluent from

the neighbouring Pfizer Biotechnology Ireland installation for treatment in the Ringaskiddy

API WWTP. The permissible maximum daily volume of effluent to be accepted shall not

exceed 240m3.

Monitoring results and incidents reported in relation to emissions to both sewer and water

were examined for 2007, 2008 and 2009 as part of this ELRA update, to determine if any

discharges from the site have the potential to result in significant environmental liabilities

at the site. This review indicated that the current arrangements on-site for the collection,

treatment and discharge of surface water and process wastewaters are sufficient and no

emissions exceeding the ELV’s set for these discharges had been recorded during the

past 3 years.

Table 4.2 below details the incidents recorded in 2007, 2008 and 2009, with regard to

emissions to water and sewer. In all cases the incidents relate primarily to minor technical

problems with sampling or monitoring equipment which were dealt with promptly and

proactively by site management, and which had no impact on the control or operation of

the WWTP. Details are as follows:

Table 4.2:

Date DESCRIPTION

Corrective Action

19.04.2007 A routine daily inspection by Pfizer technical personnel indicated that the continuous TOC analyser installed on TE1 had suffered a malfunction and ceased recording data at ca. 1700 hours on Wednesday 18-April-07. The malfunction had occurred as a result of a loss in oxygen supply to the unit. On discovery of the issue, the oxygen supply was immediately restored and the unit resumed functioning as normal. The 24-hour composite sample of effluent taken for 18-April-2007 confirms that the TOC value remained within the normal value range (Result = 58.4 mg/l).

The absence of on-line TOC monitoring did not affect the control of the Wastewater Treatment Plant (WWTP) or the quality of treated wastewater being discharged to the sewer.

The oxygen supply to the TOC monitor was successfully restored and the unit resumed normal function.

08.05.2007 During routine daily inspection by Pfizer technical personnel it was observed that the 24-hour composite sample for TE1 treated effluent for Saturday 05-May-2007 had not been collected. On further investigation of the sampling system, the sample delivery tube to the dedicated collection chamber was found to have become disconnected thus preventing the collection of the composite sample for the 24-hour period in question. This sample line was immediately successfully re-instated. 24-hour composite samples collected on 04-May-2007 and 06-May-2007 confirmed that the relevant parameters remained compliant and within normal ranges.

The continuous monitors (pH, TOC, Flow) at TE1 remained in operation and the malfunction of the composite sampling system did not impact in any way the control or operation of the site’s Waste Water Treatment Plant

The sample delivery line was immediately and successfully re-instated and composite sampling re-commenced.

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Final

(WWTP) or the quality of the waste water being discharged to sewer.

19.06.2007 A malfunction occurred of the pH analyser installed to continuously monitor the emission to sewer at TE1.

The issue was initially noted with the continuous monitor on 13-June-2007 when unstable, spurious readings occurred following which non-routine maintenance was conducted on the unit. The pH readings thereafter remained within anticipated levels and correlated with independent composite results.

It was subsequently noted that over the latter half of the weekend a disparity began to emerge between the continuous pH readings and those anticipated. This disparity was further confirmed by pH analysis conducted on independent composite samples for the corresponding 24 hour periods which remained well within licensed ranges.

Further maintenance was again conducted and the unit was successfully brought into correct operation, with readings correlating with both grab and composite samples as expected.

The malfunction of on-line pH monitoring did not affect the control of the Wastewater Treatment Plant (WWTP) or the quality of treated wastewater being discharged to the sewer.

Maintenance work was carried out on the pH probe on 13-June-2007. Further maintenance work was carried out on 19-June-2007 and the unit was restored to normal operation.

16.07.2007 A routine daily inspection by Pfizer technical personnel indicated that the continuous TOC analyser installed on TE1 had suffered a malfunction. The malfunction had occurred as a result of a blockage in the sample line to the unit. On discovery of the issue, the blockage was cleared and the unit resumed functioning as normal. In order to ascertain when the blockage occurred, a review of the trends of the continuous TOC readings over the preceding weekend period 13-15-July-2007 was conducted. It is estimated that the blockage occurred on 13-July-2007 at 09:00 hours approximately when continuous TOC readings shifted outside the normal operating range. Readings over the weekend period remained consistently below typical anticipated TOC values.

TOC results from the independent 24-hour composite sampling system for treated effluent taken for the period in question: 13-July-2007 to 15-July-2007, confirm that the TOC values remained within the normal value range.

The malfunction of on-line TOC monitoring did not affect the control of the Wastewater Treatment Plant (WWTP) or the quality of treated wastewater being discharged to the sewer.

The blockage in the samople line was immediately cleared and the TOC unit resumed normal functioning.

10.08.2007 A routine daily inspection by Pfizer technical personnel on the morning of 10-August-2007 indicated that the stormwater TC analyser had suffered a baseline zero drift and had ceased monitoring at 04:11 hours on 10-August-2007. The stormwater TOC analyser had independently suffered intermittent autocalibration issues and had ceased monitoring at 07:23 hours on 09-August-2007.

Upon discovery of the monitoring malfunction, technical personnel initiated a manual diversion of the stormwater to the site retention pond as a precaution whilst the problem was investigated. This diversion was initiated at 07:40 hours on 10-August-2007.

Technical personnel resolved the baseline drift on the TC analyser at 7:50 hours on 10-August-2007 and continuous monitoring was thereby resumed. A subsequent inspection by vendor company engineer successfully restored the TOC analyser.

The site also maintains an automated composite sampling system on the stormwater discharge point. Daily composite samples are

The baseline drift on the TC analyser was resolved by Pfizer technical personnel and monitoring was successfully resumed. Personnel from the instrument vendor company subsequently restored the TOC analyser to normal operation.

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collected from midnight to midnight and the system is independent of both the TC and TOC analysers. A portion of the composite sample being collected from 00:00 hours on 10-August-2007 was taken by technical personnel at 08:00 hours on the day. The sample taken therefore represented a composite of stormwater discharged over the period 00:00 to 08:00 hours on 10-August-2007, which includes the period during which continuous monitoring was unavailable.

Analysis of this sample by a laboratory TOC yielded a result of 12.6 mg/l which is indicative of uncontaminated stormwater and substantially below any diversion thresholds.

15.08.2007 A routine review conducted on 13-Aug-2007 of continuous

readings/trends over the previous weekend period indicated that a

malfunction occurred with the continuous pH probe on TE1

(treated effluent) at approximately 04:20 hours on 12-Aug-2007,

from which time a disparity began to emerge between the

continuous pH readings and those anticipated.

This disparity was confirmed by pH analysis conducted on

independent 24-hour composite samples for the corresponding

period which remained well within licensed ranges.

Maintenance was conducted on the continuous probe on 14-Aug-

2007 and the probe was restored to normal operation. Effluent

quality data for the period in question remained within normal

licensed ranges and validated the accuracy of the composite pH

readings.

The malfunction of on-line pH monitoring did not affect the control

of the Wastewater Treatment Plant (WWTP) or the quality of

treated wastewater being discharged to the sewer.

Maintenance

work was carried

out on the pH

probe and the

unit was

successfully

restored to

normal

measurement.

30.10.07 During routine daily inspection by Pfizer technical personnel, it

was observed that the 24-hour composite sample for Monday 29-

Oct-2007 had not been collected. On further investigation of the

sampling system, it was found that a blockage had occurred in the

sample delivery tube to the dedicated collection chamber thus

preventing the collection of the composite sample for the 24-hour

period in question. A new sample line was immediately re-instated

and composite sampling recommenced as normal.

The continuous monitors (pH, TOC, Flow) at TE1 remained in

operation and the malfunction of the composite sampling system

did not impact in any way the control or operation of the site’s

Waste Water Treatment Plant (WWTP) or the quality of the waste

water being discharged to sewer.

A new sample

delivery line was

immediately and

successfully re-

instated and

composite

sampling re-

commenced.

19.11.07 A routine daily inspection by Pfizer technical personnel indicated

that the continuous TOC analyser installed on TE1 had suffered a

malfunction and ceased recording data at ca. 0430 hours on

Monday 19-November-2007. The malfunction had occurred as a

result of a loss in oxygen supply to the unit. On discovery of the

Oxygen supply

was restored and

the unit resumed

normal

monitoring.

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issue, a replacement oxygen cylinder was ordered and supply

was subsequently restored. The unit resumed normal functioning

at ca. 1200 hours on 19-November-2007. Independent composite

samples were collected as normal. Analysis confimed that

effluent quality remained within normal ranges.

The malfunction did not affect the control of the Wastewater

Treatment Plant (WWTP) or the quality of treated wastewater

being discharged.

02.01.08 A technical issue occurred with the flow totaliser used to calculate

the daily cumulative volume of treated effluent emitted from

emission point TE-1. The issue occurred at 18:25 hours on 30-

Dec-2007 and was rectified from 00:00 hours on 31-Dec-2007.

The purpose of the totaliser is to integrate the continuous data

from the on-line volumetric flowmeter installed on TE-1 in order to

calculate the total daily volumetric flow of treated effluent. At

18:25 hours on 30-Dec-2007, a technical issue occurred with the

totaliser with the result that a total daily volumetric flow was

unavailable from the totaliser for that date.

The issue was rectified from 00:00hrs on 31-Dec-2007.

The continuous volumetric flowmeter in question remained in full

normal operation at all times.

Using independent internal meters/totalisers located within the site wastewater treatment plant, and plant daily logs, Pfizer technical personnel accurately estimated a total daily effluent flow from TE-1 of 910 m3/day for 30-December-2007. This estimate was consistent with typical daily totalised flow values under operating conditions at the time. The technical issue with the flow totaliser was rectified from 00:00hrs on 31-Dec-2007.

29.01.08 A routine review conducted at 08:00 hours on 29-Jan-2008 of

continuous readings/trends on emissons to sewer over the

previous 24 hour period indicated that the reading from the pH

monitor had gradually drifted over a number of hours and had

decreased to slightly below a reading of pH 6 at approximately

06:54 am.

Following the observation, maintenance was duly conducted on

the continuous probe and the unit was restored to correct

operation.

Independent composite and grab samples of emissions to sewer

confirmed that pH values remained within normal ranges and that

the observed continuous readings were a result of instrument drift.

Maintenance was conducted on the probe and the unit was restored to normal operation.

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03.03.08 During routine inspection of the emissions to sewer sampling

system by Pfizer technical personnel on the morning of Monday

03-March-2008, it was observed that a 24-hour composite sample

for Saturday 01-March-2008 had not been collected due a

blockage in the sample supply to the dedicated collection

chamber thus preventing the collection of a composite sample

representing that 24-hour period.

The daily

licensed

parameters

impacted by the

malfunction,

which were

tested for the 24-

hour periods

before and after

Saturday 01-

March-2008,

remained within

the IPPC licence

limit values.

The sample

supply to the

collection

chamber was

monitored over

the subsequent

days to ensure

correct operation.

02.04.08 A routine daily inspection by Pfizer technical personnel indicated

that the continuous TOC analyser installed on TE1 emissions to

sewer, had suffered a malfunction. The malfunction had occurred

as a result of a blockage in the sample line to the unit. In order to

ascertain when the blockage occurred, a review of the trends of

the continuous TOC readings was conducted and it is estimated

that the blockage occurred at 22:30 hours approximately on 01-

April-2008.

TOC results from an independent 24-hour composite sampling

system for treated effluent taken for the period in question, 01-

April-2008 to 02-April-2008, confirmed that the TOC values

remained within the normal value range.

On discovery of

the issue, the

blockage was

cleared and the

unit resumed

functioning as

normal.

25.08.08 On 24-Aug-2008 operating personnel noted a gradual

instrumental drift over a number of hours in the continuous

readings from the pH analyser installed on the emission to sewer

monitoring point TE-1. As a result of the instrumental drift the pH

readings decreased below a reading of pH 6 at approximately

02:50 hours on 24-Aug-2008. Maintenance was conducted on the

continuous probe and the unit was restored to correct operation.

Independent composite and grab samples of the emission to

sewer confirmed that actual pH values remained within normal

ranges and that the observed continuous readings were a result of

instrument drift.

A routine daily inspection by Pfizer technical personnel also

Maintenance was conducted on the continuous pH and TOC analysers and the units were restored to correct operation with recorded values being within normal ranges.

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18 June 2010

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Final

indicated that the continuous TOC analyser installed on TE1 had

suffered a malfunction and ceased recording data at ca. 09:10

hours on 23-Aug-2008. The malfunction had occurred as a result

of a loss in oxygen supply to the unit. On discovery of the issue,

the oxygen supply was restored and the unit resumed functioning

as normal.

27-May-09 A malfunction of the automatic stormwater diversion occurred in

the period 06:23 to 07:32 hours on 27-May-2009. A routine

review conducted on 27-May-2009 at ca. 07:30 hrs of continuous

readings over the previous 24 hour period indicated that there was

stormwater flow at a time when one of the two in-line pH probes

was recording results of less than 6. Readings outside the range

6-9 on either pH probe should cause an automatic diversion of the

stormwater to the onsite retention pond. The discharge occurred

during the period 06:23 to 07:32 hours. Immediately following the

observation, the storm water was manually diverted pending

further investigation.

Investigations confirmed that the pH probe in question had

exhibited gradual downward drift for some hours previously and

had caused earlier diversions as a result.

It was confirmed that the second in-line pH probe, located in an

adjacent stormwater sump and measuring the same material prior

to discharge, did not deviate outside the 6-9 range during this

time. In addition, an independent composite sample, comprised

exclusively of the stormwater discharged during the period in

question, meaured pH 7.03.

The investigation concluded that the discharged stormwater

during this period did not decrease below pH 6. The pH probe in

question was subject to further investigation and maintenance.

The stormwater

was manually

diverted to the

site retention

pond pending

further

investigation.

The pH probe in

question was

inspected by

maintenance

personnel and

returned to use.

Further

investigation was

subsequently

held into the

operation of the

diversion system

during this time.

Simulations

indicated a

software fault

which prevented

diversion during

the period in

question. A

software

adjustment was

implemented to

prevent

recurrence.

15-Jun-09 A routine daily inspection indicated that the continuous TOC

analyser installed on TE1 had suffered a malfunction. The cause

of the malfunction was a restriction in flow in the sample line to the

monitoring unit, the consequence of which was that continuous

TOC output readings from the unit were lower than expected.

On discovery of the issue, the restriction was rectified and the unit

resumed functioning as normal.

The restriction

was rectified and

the unit was

returned to normal

operation.

Independent

composite

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18 June 2010

Page 26

Final

samples of

effluent confirmed

that COD values

remained within

the normal

expected range

during the time of

the malfunction.

20-Jul-09 A routine daily inspection indicated that the continuous TOC

analyser installed on TE1 had suffered a malfunction. On

discovery of the malfunction, the external service company was

requested to conduct an inspection of the unit. This inspection

confirmed that the malfunction was caused by a fault in the carbon

dioxide detector unit within the monitoring instrument. The

instrument was repaired and returned to normal operation.

The fault was rectified and the unit was returned to normal operation. Independent composite samples of effluent confirmed that COD values remained within the normal expected range during the time of the malfunction.

23-Jul-09 A routine daily inspection indicated that the continuous TOC

analyser installed on the final treated effluent had suffered a

malfunction. The malfunction was caused by a restriction in flow

in the sample line to the analyzer unit.

The restriction was immediately rectified upon discovery restoring

the analyser to normal operation.

The restriction was immediately rectified upon discovery and the analyser was returned to normal operation. Independent composite samples of effluent confirmed that COD values remained within the normal expected range during the time of the malfunction.

18-Nov-09 The TOC analyser installed to monitor the emission to sewer at

TE1 underwent a scheduled routine service on 17-Nov-09,

conducted by specialist vendor personnel. Upon completion of the

service, it was noted that a replacement part was required in order

to restore the unit back to normal functionality. The failure of this

part (pinch valve) was unrelated to the service activity and a

replacement valve could not be sourced and fitted until the

following day.

A replacement part was sourced and installed, and the unit was restored to normal functionality. Independent composite samples of effluent confirmed that COD values remained within the normal expected range during the time of

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18 June 2010

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Final

the outage. 23-Nov-09 A routine daily inspection indicated that the continuous TOC

analyser installed on TE1 had suffered a malfunction. Data

indicated that the malfunction occurred at 09:00hrs approximately

on 22-Nov-09. The service vendor was contacted and the fault

was identified as a blockage in the unit’s internal circulation pump.

The blockage was subsequently cleared and the unit restored to

normal functionality at approx 10:30hrs on 23-Nov-09.

The blockage was cleared and and the unit was returned to normal operation. Independent composite samples of effluent confirmed that COD values remained within the normal expected range during the time of the malfunction.

There is no evidence to suggest that surface water or process wastewater releases from

the site have had any significant impact or resulted in an environmental liability.

4.3. Soil and Groundwater Quality

4.3.1. Background

Losses of organic solvents to ground have occurred historically at the Ringaskiddy site,

particularly in the area of the former southern Underground Storage Tank (UST) farm

area. All of the underground storage tanks on site were fully decommissioned and

removed by 2000 and surrounding soil area remediated.

Product recovery wells R1-R4 were installed in the limestone aquifer in the southern UST

farm area in May 1998 and additional recovery wells R5 and R6 were installed in August

1998. Pumping from the limestone aquifer continued until September 1999, following

which, wells R2, R5 and R6 were abandoned in advance of excavation of the UST farm

area, during which the soils were bioremediated.

A series of recovery wells (RC1 to RC6) were installed in the southern UST farm area

during July 2000. Dissolved phase solvent recovery commenced using two total fluids

pumps during August 2000. The RC recovery wells operated for several years and

succeeded in significantly reducing the level of residual contamination, to the extent that

the wells have now been able to cease operation.

The site continues to operate containment wells C1 and C2, which provide full hydraulic

containment from the source area. The containment wells prevent migration of any

contaminated groundwater from the site and pump this groundwater to the site

wastewater treatment plant.

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18 June 2010

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Final

4.3.2. Previous Soil and Groundwater Investigations

Several site investigations have been conducted at Pfizer Ringaskiddy. The intrusive site

investigations are summarised below chronologically.

Ove Arup/URS Investigation 1993-1994:

An initial network of nine groundwater monitoring wells (wells 1 to 9) were installed into

the drift overburden sediments by Ove Arup in 1993 (URS report 17717-013-401).

Results of groundwater sampling and analysis from well 4, located east of OSP1,

identified dissolved phase volatile organic compounds (VOCs) at elevated concentrations

in the groundwater.

URS’ initial site investigation, conducted in 1994, entailed a soil gas survey to identify

locations of elevated VOC vapours in the shallow unsaturated zone from what were

considered to be potential source areas of the dissolved phase contamination identified in

well 4. These potential source areas included the solvent recovery area, the underground

storage tank (UST) farm existing at the time and OSP1. The results of the soil vapour

survey were used to refine the locations of a number of narrow diameter soil sampling

boreholes.

Soil samples were obtained from up to 4.0 m depth. Analytical results of the soil samples

taken identified elevated VOC concentrations. The suite of compounds detected was

dominated by BTEX hydrocarbons and cyclohexane, which have low solubilities, and

alcohols, which are miscible. Well no. 4 was re-sampled and the presence of dissolved

phase contamination was confirmed. Expansion of the groundwater monitoring network

was recommended, together with preliminary testing of aquifer parameters and tidal

response.

URS Investigation 1994:

The above recommendations were carried out by URS in 1994 (URS report 17717-015-

401). The 200-series groundwater monitoring wells were installed. Included were

installations into shallow drift and deeper limestone gravel (broken limestone bedrock).

Pumping tests were conducted and hydraulic aquifer parameters were estimated for both

the drift and underlying fractured limestone.

The contaminated soils in the UST farm area were identified as a significant source and it

was found the groundwater from within the fractured limestone aquifer was more

contaminated than that within the drift. The analytical results inferred the presence of

Light Non Aqueous Phase Liquids (LNAPL) at the time, i.e. a floating layer of organic

solvents on the water table within the limestone.

The direction of groundwater flow within the limestone was identified as being toward the

east. It was expected to enter the harbour beneath the former ADM jetty. As the drift

deposits became thicker to the east no monitoring wells were installed into the limestone

at that time, therefore the extent of contamination within the limestone aquifer to the east

was not identified. As an outcome of this investigative phase, it was recommended that

the network of groundwater monitoring wells be extended to the east.

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18 June 2010

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Final

URS Investigation 1995/1996

Additional groundwater-monitoring wells (the 400-series) were subsequently installed,

primarily in limestone and primarily in the east of the site. Two of the boreholes were

cored and selected cores were laboratory tested for porosity, hydraulic permeability, dry

bulk density and fraction of organic carbon (URS report 17717-018-401).

It was found that the groundwater flow direction became more northerly below the current

drum storage area. It was also found that an upward hydraulic gradient from the

limestone to the drift was present in the east of the site. The lower contaminant

concentrations detected in the 400-series wells confirmed in-situ degradation to be an

effective process of attenuation.

As a result of this investigative phase, it was recommended that hydraulic containment be

adopted to prevent dissolved phase plume migration off-site. Following completion of

these three separate phases of site investigation and characterisation, the hydraulic

containment system was commissioned in February 1996.


Remediation works were carried out in 1998 during which the northern UST farm was

removed, soils were remediated by ex-situ bioremediation and recovery wells (R-series)

were installed in the UST farm area in response to 1998 solvent losses. Pumping from the

limestone aquifer continued in recovery well R6 using a total fluid pump until September

1999, following which, wells R2, R5 and R6 were abandoned in advance of excavation

and removal of the southern UST farm area.

The 700-series monitoring wells were also installed by URS in 1998 in the vicinity of

OSP4 to investigate possible groundwater contamination in this area. No significant

levels of VOCs have been detected in these wells.


A series of recovery wells (RC1 to RC6) were installed in the former southern UST farm

area during July 2000. Rock coring allowed detailed mapping of the bedrock fracture

network beneath the UST farm. Dissolved phase solvent recovery commenced using two

total fluids pumps during August 2000. Pumping in the RC area ceased in May 2006 after

considerable success in reducing contaminant levels.

Ongoing Groundwater Monitoring and Management

An extensive programme of groundwater monitoring and well inspections is carried out

biannually by third party consultants. The previous three reports, two in 2009 and one from

2008 were reviewed. Long-term monitoring results show that VOC and alcohol concentrations

across the site have decreased significantly since the mid-1990s. This is attributed to a

combination of engineering upgrades, removal of underground storage tanks, past

groundwater abstraction from the former underground storage tank farm area, and the

continued operation of the hydraulic containment system onsite. The dissolved

concentrations are expected to continue to decrease further as residual contaminated

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18 June 2010

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Final

groundwater is contained and treated, although the rate of mass removal has decreased with

time, as the majority of the mobile solvent contamination has been removed from the area of

the former underground storage tank farm. There were increases in tetrahydrofuran (THF)

and to a lesser magnitude, increases in methyl tert Butyl ether (MTBE) concentrations in wells

in, and downgradient of, the Solvent Recovery Area in 2009. The particularly wet weather

since 2007 and/or some recent development in the original source area may have combined

to create a greater level of leaching of contamination. The potential for intermittent splash

droplets during washing in a manifold area may also have been a possible contributory

cause, which may be minimised by the erection of a splash guard. THF and MTBE

concentrations are expected to reduce with time. The trends in these VOCs will continue to

be monitored biannually.

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Final

5. EXISTING ENVIRONMENTAL CONTROLS AT PFIZER

5.1. General

The Pfizer manufacturing facility at Ringaskiddy is equipped with a high level of

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

the efficient operation and maintenance of environmental protection systems/practices,

and their upgrade where necessary, together with ongoing efforts aimed at the

continuous minimisation of emissions. The site has a programme of continuous

improvement typical of a mature facility, through for example the training of people to

maintain good environmental practices, and replacement, upgrading, retro-fitting, as

needed, of instrumentation and equipment.

Pfizer Inc., the global parent company, has issued a statement of Environmental Policy

incorporated into a global environment, health and safety policy. The site at Ringaskiddy

also has its own Environmental Policy Statement. The policy aims to instil high

environmental values in all employees, utilising the best environmental practices in

processing and contributing to global sustainable developments.

Over the years, the Ringaskiddy plant invested heavily in infrastructure designed to

assure a high level of environmental compliance and protection. Examples of significant

capital investment include the design, construction and commissioning of the site

wastewater treatment plant, three VOC Absorption Plants, and a Thermal Oxidiser.

The site has invested substantial sums in the installation and upgrade of onsite solvent

recovery facilities, which allow the efficient reclamation of solvent from waste streams.

The recovered solvent is subsequently re-used in processing. The site recovers a

substantial proportion of solvent in this way, typically in the region of 30-40% of

throughput.

The site maintains an in-house Environmental Monitoring Unit (EMU), the function of

which is to provide environmental monitoring support services. The EMU monitors

emissions to air, sewer, and stormwater for a wide range of licensed parameters.

Environmental protection and compliance is integrated into the site decision-making

process through the management of change mechanisms defined in the site’s certified

ISO 14001 Environmental Management System (EMS).

The site operates an extensive energy and resource conservation programme, and in

2004 was awarded the Sustainable Energy Ireland (SEI) National Energy Award for the

site’s Energy Information Management System. In 2005, the site received the SEI

National Award for the Best Energy Awareness Campaign, and also received the SEI

Industry Sector Award for Best Electrical Energy Project for a novel compressed air ring-

main project. Finally, in 2008 the site won an SEI award for its Energy Awareness

campaign.

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18 June 2010

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Final

5.2. Environmental Management

Pfizer operates an integrated approach to the management of environmental aspects of

the site, and environmental protection and compliance has always been a key

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

system. The site environmental management system (EMS) is certified to the

international standard ISO 14001.

The environmental management system is based on a combination of technical

measures and documented environmental management programmes and procedures,

whose objectives include:

� Complying with all the requirements of the site IPPC licence;

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

releases to the environment; and

� Ongoing continuous improvement of site environmental performance.

5.3. Releases to Atmosphere

In each of the three production buildings clean technology is used to minimise process

emissions at source. Pfizer also employ a range of abatement, treatment and recovery

systems to minimise air and dust emissions to the environment from the manufacturing

process. These systems include:

1. Scrubbers: Scrubbers are treatment systems installed in each production building

to neutralise the pH of waste process gas streams and to help remove inorganic

components. Some absorption of water soluble VOCs from the waste gas stream

also occurs in the scrubbers. The scrubbed waste gas is then ducted to

dedicated VOC Absorption Plants in the case of OSP1, OSP2 (currently

decommissioned) and OSP3, or to a Thermal Oxidiser in the case of OSP4.

2. VOC Absorption Systems: Absorption is a treatment system used to remove

VOCs from process waste gas streams. Regenerative systems comprising of an

absorption and desorption column are provided for the production buildings

OSP1, OSP2 (currently decommissioned) and OSP3 as the primary end of line

treatment process. Carbon beds were installed post the VOC plants as polishing

filters. Treated emissions from the VOC absorption systems are continuously

monitored.

3. Vent Condensers: Vent condensers are provided on many process vessels to

recover solvents from vent emissions. The vent condensers are installed on the

vent lines from production vessels such as reactors or receiver tanks, which may

have the potential to contain high volumes of solvent. The VOCs condensed in

the vent condenser are returned to the process vessel from which they originated

thereby minimising waste and increasing solvent recovery.

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Final

4. Biofilters: Biofilters are treatment systems used to minimise emissions to air from

the WWTP. Waste air from the first stage aeration basins, potentially containing

VOCs, are collected and ducted to peat-based biofilters. There are four biofilters

installed on each first stage basin. The biofilters act to biodegrade VOC material,

and simultaneously eliminate any potential odours.

5. Blowdown Tanks: Blowdown tanks are containment systems provided in OSP2

(currently decommissioned), OSP3 and OSP4 to minimise emissions to air

should there be an accidental discharge caused by overpressurisation of a

vessel. In the event of overpressurisation of a vessel the accidental emission

from the vessel would be contained in the blowdown tank.

6. Conservation Vents: Conservation vents fitted on overground storage tanks are

designed to minimise vapour emissions to air. The conservation vent is normally

closed and so prevents emissions to air from the storage tank. The conservation

vent allows intake of air and escape of vapours within permissible working

pressures and thus avoids damage to the tank.

7. HEPA Filters: High Efficiency Particulate Air (HEPA) filtration is used on

equipment that may handle pharmaceutical dusts. Emissions that may contain

pharmaceutical dusts are HEPA-filtered before being discharged to atmosphere.

The HEPA filters are highly efficient and are generally designed to achieve

99.997% removal of particulates from the exhaust.

8. Thermal Oxidiser: The primary end-of-line abatement system for the OSP4

manufacturing building is a thermal oxidiser. Process gas emissions from OSP4

are initially scrubbed and then ducted to the thermal oxidiser where VOC

destruction occurs by combustion. Natural gas is used as the supplemental fuel.

Final emissions from the thermal oxidiser are continuously monitored.

5.4. Releases to Surface Water and Groundwater

5.4.1. General

Emissions to surface water are subject to the monitoring programme as specified in IPPC

licence No P0013-04.

There are many mechanisms in place on the Pfizer site to prevent contamination of

surface and groundwater from process and non-process sources. Process effluents are

routed directly to the effluent treatment system and non-process effluents have

mechanisms in place to prevent surface water and groundwater contamination.

There are currently four separate drainage systems at Pfizer:

1. Weak Stream Drainage System

2. Strong Stream Drainage System

3. Surface (Storm) Water Drainage System

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18 June 2010

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Final

4. Domestic Wastewater Drainage System

The weak effluent drainage system carries weak predominantly aqueous effluent such as

floor washings, equipment externals washings, and rainwater accumulations in tank

bunds. The weak effluent from OSP1, OSP2 (currently decommissioned), OSP3 and

OSP4 discharges to various ejector stations or collection tanks. From these points it is

pumped to the Wastewater Treatment Plant.

Strong Effluent comprises waste streams, which are mainly generated within the

manufacturing process and within plant vessels. Strong effluent generally therefore has

higher COD loads, and may include suitable streams such as mother liquors and

aqueous decants. This effluent is collected in a separate above ground system conveyed

in overhead pipe racks and pumped to balancing tanks at the upstream end of the

Wastewater Treatment Plant. From here it is fed forward at a controlled rate to the

WWTP for treatment.

Pfizer Ringaskiddy requested a technical amendment of the licence at the end of 2008 to

receive effluent from the new Pfizer Biotechnology facility adjacent to the installation.

Technical amendment B was issued by the EPA in February 2009. The licence restricted

Ringaskiddy to accepting a maximum of 240m3/day from the Pfizer Biotechnology plant.

In general, surface water run-off, from the site paved areas and roofs, drains to the

stormwater collection system. Some locations immediately adjacent to some processing

areas, where a risk of spillage may exist, drain to weak effluent.

Surface water is sampled and monitored at two locations:

1. Upstream of the stormwater retention pond: There is a dedicated TC (Total

Carbon) analyser and a pH probe continuously monitoring the surface water just

upstream of the automatic diversion to the stormwater retention pond. The signal

from this TC analyser and the pH probe will register an alarm in the Production

Services Control Room if an out-of-specification reading is recorded. This will

also result in the automatic diversion of the surface water to the stormwater

retention pond, where it may be contained and if necessary subsequently

pumped to the WWTP for treatment.

2. On the line to the stormwater outfall: The surface water flowing to the stormwater

outfall is monitored for flow rate, pH and TOC concentrations. The flow, pH and

the TOC signals are monitored by wastewater treatment plant control system,

which will register an alarm if out-of-specification readings on TOC or pH are

recorded. This will also result in the automatic diversion of the surface water to

the stormwater retention pond, where it may be contained and if necessary

subsequently pumped to the WWTP for treatment.

The auto-diversion system may be over-ridden by a manual diversion if required.

The weak and domestic drainage systems, where these are underground, together with

vessel bunds, are tested for integrity on a three-year rolling basis. Where possible, lines

are hydraulically tested. When necessary, mobile CCTV inspections may be performed.

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Final

Any maintenance and repairs or modification identified are carried out and are subject to

re-test. Parts of these systems are tested each year with a view towards having all

sections of the network tested in the three-year schedule.

Where possible, overground pipework carrying materials other than water, is routed away

from soil or gravelled areas, and instead is provided with its own dedicated local

containment, or is routed over paved and drained areas, with remote containment thereby

provided by the stormwater auto-diversion system. A review of potential catchment areas

for overground lines resulted in a significant reduction in the amount of pipework routed

across uncontained areas.

Bulk solvent storage tanks, which are located overground, are installed in bunded areas.

Each bund is capable of holding at least 110% of the capacity of the largest tank within

the bund. Bunds are integrity-tested on a three-year rolling basis as described

previously.

5.5. Emergency Planning/Preparedness

The site has a detailed and documented Emergency Response Plan (ERP). The ERP

describes the emergency response system onsite and also contains specific action plans

in the event of particular incidents such as the release of gaseous materials, liquids,

solids, etc. The site has a designated Emergency Controller available at all times during

plant operation. A trained emergency response team is also available at all times during

plant operation, with members drawn from the across the site operations.

Emergency exercises designed to test and refine the effectiveness of the Emergency

Response Plan are carried out regularly and various scenarios are presented to the

participants. A critique of the exercise is completed afterwards. These exercises may

range from desk-top considered response exercises to real-time response exercises.

The intention is to continually present participants with different scenarios in order to

maximise the effectiveness of their response in the event of an actual emergency.

5.6. Prevention of Fire

5.6.1. Procedures

The plant Emergency Response Plan specifies the actions taken on discovering a fire or

other emergency. The ERP includes the activation of fire alarms, gas alarms, site

evacuation alarms, and evacuation and assembly requirements. Fire prevention is

emphasised by engineering design, work permit restrictions, work practices, and ongoing

audits and safety awareness. Operation instructions and Material Safety Data/Information

Sheets specify emergency response requirements for various materials being used.

5.6.2. Training

All employees are provided with an induction training module, which provides details on

the site emergency response system and general environment, health and safety

awareness. Employees are also provided with training on the use of fire extinguishers.

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Final

Full evacuation drills are held periodically to familiarise employees with evacuation

requirements and to ensure head counts are completed effectively. All contractors

receive induction training prior to being allowed work onsite.

5.6.3. Emergency Crew

As described earlier, the site has a designated Emergency Controller available at all

times during plant operation. A trained emergency response team is also available at all

times during plant operation, with members drawn from the across the site operations.

Members of the emergency team undergo regular training by specialist external

consultants. This training includes live scenarios in specially-designed training centres,

together with ongoing familiarisation with equipment and techniques.

5.6.4. Equipment

The plant fire protection system includes sprinkler and deluge systems installed as

appropriate in areas where flammable liquids are stored and handled. Smoke and heat

detectors are similarly installed at key locations throughout the plant. All of the systems

are monitored by fire alarm panels which control alarms activation. A dedicated fire water

ring-main ensures a continuous supply of firefighting water across the site at all times.

A fully-equipped fire station is available onsite, housing a fire tender and an emergency

response control van.

5.6.5. Storage and Handling of Flammable Materials

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

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

are confined to sealed systems of vessels and pipes during processing. Bulk storage

tanks are sprinkler or deluge protected. Warehousing is sprinkler protected. Nitrogen gas

is used in manufacturing vessels to create an inert atmosphere. Rated electrical

equipment is used in zoned areas, and bonding and grounding of non-conductive

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

electricity.

5.6.6. Firewater Retention

With regard to potential contamination of surface water from firewater, it is assumed that

in the event of a fire on site that the firewater run-off may be contaminated with

chemicals. The stormwater retention pond described in in Section 5.4.1 functions also as

the firewater retention basin for the site.

5.7. Hazard Studies

Ringaskiddy API plant is classed as an upper-tier establishment under the European

Communities (Control of Major Accident Hazards Involving Dangerous Substances

Regulations 2006 SI 76 of 2006). The installation operates a number of tiered systems to

ensure that process hazards are identified and corrective actions implemented to

minimise risks to acceptable levels.

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New products are assessed at an early stage to identify potential major hazards prior to a

detailed Hazard Review stage. The protocol involves the collation and assessment of

relevant hazard data such as reaction, ignition, toxic and dust explosion hazards. It also

provides guidance on the detailed reaction data required prior to the next stage of Hazard

Study.

During a Hazard Study, the hazards associated with processes, plant or modifications to

plant are examined and understood, and actions identified to ensure that hazards are

adequately controlled. The study procedure provides the plant with the tools to determine

the magnitude of potentially significant hazards and to evaluate the ability of existing

processes, safety systems and procedures to prevent, control or minimise the risks

involved. Depending on the significance of the change, a full formal Hazard and

Operability (HAZOP) study may be performed as part of the Hazard Study process. The

purpose of the hazard review system is to identify and rectify identified issues at an early

stage so as to ensure that when the equipment or process becomes operational, any

associated risks are minimised.

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6. SITE SPECIFIC ELRA ASSESSMENT

6.1. General

For facilities such as the Ringaskiddy API 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.

6.2. Methodology – Risk Identification, Likelihood and Consequence

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

• Risk Identification

• Risk Classification (includes an Occurrence Assessment and a Severity Assessment)

• Risk Evaluation

• Risk Prevention/Mitigation

6.2.1. Risk Identification

Risks where identified on the site through a combination of:

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,

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Final

identify potential causes of failure of the processes and analyse the potential

impacts on the environment.

2. Site Visit – A one day site visit to the facility was carried out to examine all

process areas, storage areas and associated utilities present at the Pfizer

Ringaskiddy site

Table 6.1 Example Hazard Identification Table

Risk ID Potential Hazard Environmental Effect

1 Describe scenario for occurrence of

potential liability e.g. spill of solvent from

solvent storage tank

Describe consequence of

proposed scenario e.g. spill

of solvent 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 Pfizer.

The following table defines various likelihoods of occurrence:

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 Greater than 50% chance of 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

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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 Pfizer

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.

V. High 5 High 4

Medium 3 Low 2

Occu

rren

ce

V. Low 1 1 2 3 4 5

T

rivia

l

Min

or

Mo

dera

te

Majo

r M

assiv

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.

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� 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 identified risks appropriate financial provision must be made to address any

associated liabilities. With regard to ‘medium’ and ‘high’ risks the ELRA must detail how

these risks will be minimised to acceptable levels.

6.2.5. Risk Prevention/Mitigation

Mitigation measures are assigned to each risk 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 or

implemented. A Risk Management Programme is then prepared for the ongoing

management of risks and the implementation of risk mitigation measures. Target

timeframes are also allocated for the implementation of each risk mitigation measure.

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Final

6.3. Identification of Risks at Pfizer

During the one day site visit and utilising information supplied by Pfizer Ringaskiddy, 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 identified from the failure, the effect was analysed and this was

listed as a Risk. A Risk Register was then developed which contained all of the Risks

identified on site.

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

all risks associated with the process in question. A list of risks was developed and these

were entered into a Risk Register. Table 6.4 illustrates the Risk Register.

Table 6.4 Pfizer Risk Register

Risk

ID

Potential Failure Mode

1 A spill occurring during the loading/unloading of chemical/fuel/other storage tanks

on-site.

2 A failure of one of the bulk storage tanks resulting in a spill of chemicals/waste.

3 Loss of integrity within bunded areas.

4 Improper disposal of hazardous waste.

5 Uncontrolled release of hazardous/toxic gases to atmosphere.

6 Uncontrolled release of API dust to atmosphere.

7 Failure of underground process drainage network resulting in leakage of material

into soils and groundwater.

8 Major failure of aboveground pipeline.

9 Undetected leak in aboveground pipeline.

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

11 An on-site fire/explosion.

12 Power failure resulting in failure of on-site environmental control systems.

13 Accidental/uncontrolled release of strong stream effluent to weak stream drainage

network.

14 Accidental/uncontrolled release of strong/weak stream effluent to stormwater

drainage system.

15 Failure of WWTP resulting in discharge of untreated effluent to sewer.

16 Failure of on-site environmental control and monitoring systems.

17 Site Closure.

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

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

of risk appropriate to the Pfizer site. Ratings, taken from the relevant risk classification

table, were applied to the severity and likelihood 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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Final

Table 6.5 Risk Assessment

Risk

ID

Process Potential Hazard Environmental Effect Occurrence

Rating

Basis of Occurrence Severity

Rating

Basis of Severity

1 Loading/

Unloading

Spill of oil or

chemicals

which migrate

to surface water

or ground.

Surface Water

Groundwater or Soil

Contamination.

2 Chemicals, solvents and oil delivered

to site on a daily basis. Documented

procedures available.

Loading and unloading of solvent

takes place in designated contained

areas draining to weak effluent. Any

potential ingress to stormwater would

be detected by continuous monitors

and trigger autodiversion to retention

pond. Stormwater diversion system

provides remote bunding for

remaining paved areas.

3 Potential costs associated with remediation. Any impact on soil, groundwater or surface water would be localised.

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Final

Risk

ID


Rating


Rating

Basis of Severity

2 Storage of liquid

materials in bulk

storage tanks.

Bulk storage

tank failure.

Surface Water

Groundwater or Soil

Contamination.

2 All bulk solvent storage tanks are located within local bunded areas; retention capacity is at least 110% of the largest tanks. Remote bunding is provided by a stormwater retention pond with autodiversion capability.

3 Large volume bulk storage tanks on-site. Certain materials therein have the capacity to cause environmental damage if failure was to occur resulting in ground and/or surface water contamination. Any impact on soil, groundwater or surface water would be localised.

3 Storage of liquid

materials in bulk

storage tanks.

Loss of integrity

of bunded

areas

Surface Water

Groundwater or Soil

Contamination.

2 There have been incidents of bunded areas failing integrity testing. However, these failures were minor and would not have resulted in significant leakage even had they coincided with tank failure. Such failures are corrected by normal maintenance repair. Bunds are inspected regularly at the site. Any spillage observed within the bunds would be promptly detected and cleaned up.

3 Large volume bulk storage tanks on-site. Certain materials therein have the capacity to cause significant environmental damage if failure was to occur resulting in ground and/or surface water contamination. Any impact on soil, groundwater or surface water would be localised.

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Final

Risk

ID


Rating


Rating

Basis of Severity

4 Disposal of

Hazardous

Waste

Improper

classification/

disposal of

waste.

Surface Water

Groundwater or Soil

Contamination. Public

Health Risk if

hazardous waste is

disposed of in non-

hazardous manner.

1 As processes on-site can change over time, therefore so can associated wastes. Minor examples of analytical discrepancies in solvent waste have occurred in the past; however these were detected and rectified without any environmental impact. In no case did this result in the incorrect hazardous versus non hazardous classification of waste. Due to procedures used onsite, very unlikely that a large quantity of waste would be incorrectly disposed of or treated.

5 If a large quantity of waste was incorrectly categorised, it could potentially result in financial implications.

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Final

Risk

ID


Rating


Rating

Basis of Severity

5 Production Release of haz/

toxic gas to

atmosphere in

excess of ELVs.

Risk to human health in

surrounding area.

Contamination of air.

5 Historical incidents of emission, exceeding ELVs of IPC/IPPC licenses at the site. An emission in excess of the ELVs at one of the emission points would be expected to have a greater than 50% chance of occurring over a 30 year period.

1 Emissions in excess of ELVs typically occur as a result of abatement equipment malfunctions or problems with the production process. Unlikely that a large quantity of waste would be emitted as existing monitoring and control techniques employed at the plant would alert the relevant production personnel to promptly shut down the process causing the emission. ELV exceedences would be expected to be transient.

6 Production Release of haz/

toxic material

(API Dust) to

atmosphere in

excess of ELVs.

Risk to human health in

surrounding area.

Contamination of air.

5 Historical incidences of exceedences of ELV’s. An emission in excess of the ELVs at one of the emission points would be expected to have a greater than 50% chance of occurring over a 30 year period.

1 Unlikely that a large quantity of material would be emitted. Unlikely that a large quantity of waste would be emitted as existing monitoring techniques employed at the plant would alert the relevant production personnel to shut down the process causing the emission.

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Final

Risk

ID


Rating


Rating

Basis of Severity

7 Disposal of

wastewater

Failure of

underground

process

drainage

network

resulting in

significant

release to

ground and

groundwater.

Surface Water

Groundwater or Soil

Contamination.

2 The underground process drainage networks may develop faults over a 30-year period however as underground weak and domestic drainage network is tested every three years and repaired as necessary only minor defects should occur. Furthermore, weak and domestic effluents are not significant environmental streams. Strong effluent, consisting of waste streams from manufacturing, for the site is conveyed in aboveground pipelines.

3 Severity is based mainly on potential costs associated with repair of underground drains and possible soil remediation if major discharge were to occur. Weak and domestic effluents are not significant environmental streams. Any impact on soil or groundwater would be highly localised.

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Final

Risk

ID


Rating


Rating

Basis of Severity

8 Transfer of

Materials

Major Failure of

above ground

piperack

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 pipeprack failure. Major failure is unlikely to occur unless an incident such as collision with an item of plant on-site was to occur.

Pipe racks onsite, which cross internal roadways, are designed to heights sufficient to accommodate movement of all vehicles which would come on to the site. With respect to construction or other similar equipment, the site operates a permit-to-work system for all such work onsite. The presence of pipework would be considered and evaluated as part of this and would prevent the possibility of collision of large items of plant with the piperack.

The plant is manned continuously during operations. A major failure of a piperack would likely be reported promptly and material transfer would cease. A substantial portion of surface areas under piperacks are either bunded or hardstanding and drain to either the weak stream effluent network or the surface water network. Both systems have controls in place which would minimise the risk of migration of material from the site.

3 Severity based on costs associated with clean up if material were to migrate beyond control boundaries. Any impact on soil, groundwater or surface water would be localised.

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Final

Risk

ID


Rating


Rating

Basis of Severity

9 Transfer of

Materials

Minor leak in

piperack

system.

Surface Water

Groundwater or Soil

Contamination.

2 There have been previous incidents of minor leaks in the piperack system.

The plant is manned continuously during operations. Minor leaks are unlikely to go unnoticed for a long period of time. Previous incidents have all been detected within a short period of incident occurring.

1 No damage or negligible

change to the environment

10 Production Spillage of

quantity of

hazardous

material in

production

areas.

Risk to human health.

Surface Water

Groundwater or Soil

Contamination if

material migrates

outside production

areas.

1 Internal production areas drain to the

weak stream drainage network. Spill

would be conveyed to WWTP for

treatment. Balancing tanks upstream

of treatment process allow for

adjustment to incoming influent

strength and therefore there should

be no impact on operation of WWTP.

A trained and equipped Emergency

Response Team is available onsite,

with the capability to control and

contain spillages of hazardous

materials.

3 If large spill were to

migrate beyond existing

containment measures, it

would result in moderate

damage to the

environment as significant

volumes of hazardous/toxic

material could be

contained in production

runs.

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Final

Risk

ID


Rating


Rating

Basis of Severity

11 Any Major on-site

fire or

explosion.

Release of toxic and

hazardous material to

atmosphere, surface

water, groundwater.

2 Comprehensive control systems and

maintenance programme in place to

minimise the risk of fire.

Comprehensive Emergency

Response Plan in place at the site.

All processes, equipment and

techniques used on site are in line

with industry-standard manufacturing

techniques.

Very high standard of fire protection

and detection at the site. Designed at

containing and preventing the spread

of fire.

4 Significant quantities of

flammable materials stored

at the site.

No method of containing

emission to air so little cost

involved in clean up.

Mitigated by dilution in air.

Firewater retention pond is

available, with full

autodiversion capability. In

the event that

contaminated firewater

entered local surface

water, may be high cost

associated with

remediation.

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Final

Risk

ID


Rating


Rating

Basis of Severity

12 Energy Supply Power Failure

resulting in

failure of on-site

environmental

control

systems.

Uncontrolled releases

to air and surface

water.

2 A general power failure on-site also

would result in shutdown of activities,

including manufacturing, and so the

source of emissions would

simultaneously cease.

Situation has been addressed in the

Emergency Response Plan for the

site. Backup power generation

provided on-site via diesel fuel

generators. Generators are checked

and maintained on a regular basis.

3 Moderate damage to the

environment.

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Final

Risk

ID


Rating


Rating

Basis of Severity

13 Process

wastewater

handling

Accidental/

uncontrolled

release of

strong stream

effluent to the

weak effluent

drainage

network.

Failure of on-site

WWTP resulting in

discharge of untreated

effluent to Cork County

Council Sewer and

subsequent release to

surface waters.

1 It is unlikely than the quantities of

strong stream effluent which could

be accidentally released to the weak

stream drainage network would have

any significant effect on the

operation of the WWTP.

Any strong stream wastewater

emitted to the weak steam effluent

drainage network will be transferred

to the balancing tanks upstream of

the WWTP. At this point, wastewater

from the weak stream tank and

strong stream tank are mixed for

release into the WWTP. Any spill into

the weak stream drainage network

would therefore result in less strong

stream effluent being pumped

forward for treatment from the strong

stream tank. The WWTP is an

aerobic activated sludge system and

so operates on extended hydraulic

retention times. An adverse impact

on WWTP operation would therefore

take some days to affect effluent,

allowing time for ameliorative

measures.

3 Costs associated with

remediation if risk

occurred.

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Final

Risk

ID


Rating


Rating

Basis of Severity

14 Process

wastewater

handling

Accidental/

uncontrolled

release of

strong/weak

stream effluent

to the surface

water drainage

network.

Contamination of

surface water.

2 Surface water emissions are

continuously monitored for pH and

TC/TOC. In the event of a spill

occurring, this would be detected

and surface water discharges from

the site would be automatically

diverted to the stormwater retention

pond.

The material in the retention pond

may then be pumped to the WWTP

for treatment if necessary.

2 Minor impact/localised or

nuisance

15 Process waste

water treatment

Failure of

WWTP

resulting in the

release of

untreated

wastewater to

the Local

Authority sewer.

Contamination of

surface water

1 The existing WWTP has sufficient

buffering capacity to deal with

significant fluctuations in influent

feed. Emissions to / from the WWTP

are monitored for various

parameters. The WWTP is an

aerobic activated sludge system and

so operates on extended hydraulic

retention times. An adverse impact

on WWTP operation would therefore

take some days to affect effluent,

allowing time for ameliorative

measures.

3 Costs associated with

remediation if control

systems failed and major

discharge occurred.

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Final

Risk

ID


Rating


Rating

Basis of Severity

16 Monitoring and

Control Systems

Failure of on-

site

environmental

control systems

Release of toxic and/or

hazardous material to

atmosphere, surface

water, groundwater

2 Minor malfunctions of monitoring and

control equipment have occurred in

the past. These malfunctions were

detected promptly by plant control

systems and rectified without the

development of any environmental

liabilities. The site operates an

ongoing preventative maintenance

programme.

2 Minor impact/localised or

nuisance

17 Site Closure Various Various 3 Existing site can accommodate

changes to process manufacturing

techniques quite easily.

4 Costs associated with Site

closure – the site has

developed a detailed

Residuals Management

Plan to manage closure

and any subsequent

remediation if required.

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Final

6.4. Assessment of Risks at Pfizer

6.4.1. Risk Register

The risk register below ranks the risks in order to prioritise mitigation and management

measures.

Table 6.6 Risk Register ranked by Risk Score

Risk ID Description Occurrence Rating

Severity Rating

Risk Score

17 Site Closure. 3 4 12

11 Major Fire/Explosion. 2 4 8

1 Spill from loading/unloading operations.

2 3 6

2 Bulk Storage tank failure. 2 3 6

3 Bund Integrity Failure. 2 3 6

7 Failure of underground process drainage network.

2 3 6

12 Power Failure 2 3 6

4 Improper classification/ disposal of waste.

1 5 5

5 Emissions to atmosphere in excess of ELV’s.

5 1 5

6 Uncontrolled emissions of toxic/hazardous material to air (API dust).

5 1 5

14 Accidental/uncontrolled release of strong/weak stream effluent to surface water drainage system.

2 2 4

16 Failure of on-site environmental control systems.

2 2 4

8 Major failure of aboveground pipe rack.

1 3 3

10 Spillage of hazardous material in production areas.

1 3 3

13 Accidental/uncontrolled release of strong stream effluent to weak stream system.

1 3 3

15 Failure of WWTP Process 1 3 3

9 Undetected leak in piperack system.

2 1 2

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Final

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 Risk ID 5, 6

High 4

Medium 3 Risk ID 17

Low 2 Risk ID 14, 16

Risk ID 1, 2, 3, 7, 12

Risk ID 11

Occu

rren

ce

V. Low 1 Risk ID 9

Risk ID 8, 10, 13, 15

Risk ID 4

1 2 3 4 5

T

rivia

l

Min

or

Mo

dera

te

Majo

r M

assiv

e

Severity

Where:

Red is a high level risk.

Yellow is a medium level risk.

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

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

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

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

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

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

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

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

risks on a regular basis.

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Final

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 risks were classified as green zone risks and require

monitoring on a regular basis.

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

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

their current levels or reduce them further, these may be implemented if considered cost-

effective.

Table 6.8 illustrates the risk mitigation measures which have been identified or are

currently in use at the site. This table provides the risks in descending order of risk score

with the proposed mitigation measure.

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Final

Table 6.8 Risk Mitigation Form

Risk

ID Process Potential Hazard

Risk Score

before

Mitigation

Existing/Possible Mitigation

measures Risk Manager

Time to

Complete

Revised

Risk

Score

17 Site Closure Site Closure. 12

Preparation of Residuals Management Plan (RMP) and

appropriate financial provisions. Review of RMP on an annual

basis.

Team Leader, Environment

Ongoing / Existing Practice

12

11 Any Major Fire/Explosion. 8

Maintain on-site fire detection and control systems including trained

emergency reponse team.

Update Emergency Response Plan as required taking account of

changes to site.

Provision of training to employees.

Provision of firewater retention facilities.

Team Leader, Safety


Ongoing /

Existing

Practice 8

1 Loading/

Unloading

Spill from loading/unloading

operations. 6

Designated solvent loading/unloading areas in areas that are either bunded or drain to weak stream effluent system. Any

potential ingress to stormwater would be detected by continuous monitors and trigger autodiversion

to retention pond. Stormwater diversion system provides remote

bunding for remaining paved areas.



6

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18 June 2010

Page 60

Final

Risk


Risk Score

before

Mitigation



Time to

Complete

Revised

Risk

Score

2

Storage of liquid

materials in bulk

storage tanks.

Bulk Storage tank failure.

6

Ensure all tanks are located in properly bunded areas capable of

containing 110% of volume of largest tank. Maintain existing

bund integrity testing programme.


Ongoing /

Existing

Practice 6

3 Storage of Materials

Bund Integrity Failure. 6 Testing of bunds as per IPPC

Licence and repair of any defects detected.



6

7 Disposal of wastewater

Failure of underground process drainage

network. 6

Testing of underground weak and domestic drains as required under

condition of IPPC Licence and repair of any defects detected.


Ongoing /

Existing

Practice 6

12 Energy Supply Power Failure 6

Back-up power generation on-site.

Maintenance of on-site emergency generators.

Maintain procedures in the Emergency Response Plan

outlining necessary action to be taken in such an event.

Engineering Leader

Team Leader, Safety

Ongoing /

Existing

Practice 6

4

Disposal of

Hazardous Waste Improper classification/

disposal of waste. 5

Analysis of each solvent waste load leaving site.

Production Services Leader

Ongoing /

Existing

Practice 5

5 Production Emissions to

atmosphere in excess of ELV’s.

5

Maintenance of end of pipe abatement systems

Continuous monitoring required of existing control systems.

Plant Leaders

Ongoing /

Existing

Practice 5

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18 June 2010

Page 61

Final

Risk


Risk Score

before

Mitigation



Time to

Complete

Revised

Risk

Score

6 Production

Uncontrolled emissions of toxic/hazardous material to air (API

dust).

5

Maintenance of end of pipe treatment technologies.

Maintenance of existing control systems.

Plant Leaders

Ongoing /

Existing

Practice 5

14

Process

wastewater

handling

Accidental/uncontrolled release of strong/weak

stream effluent to surface water drainage

system.

4 Maintenance of continuous monitoring on surface water

discharges.


Ongoing /

Existing

Practice 4

16 Monitoring and

Control Systems

Failure of on-site environmental control

systems. 4

Continue preventative maintenance programme and

inspection programme.

Plant Leaders

Maintenance Leader

Ongoing /

Existing

Practice 4

8

Transfer of

Materials Major failure of

aboveground piperack. 3

Ensure piperacks which cross internal roads are designed at

heights in excess of any moving vehicles permitted to be on the

site.

Maintain a permit-to-work system for all construction work carried out

at the site.

Engineering Leader

Plant Leaders

Ongoing /

Existing

Practice 3

10 Production Spillage of hazardous material in production

areas. 3

All production areas drain to weak stream effluent system.

Training of emergency response team on spill control.

Plant Leaders

Team Leader, Safety

Ongoing /

Existing

Practice 3

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Final

Risk


Risk Score

before

Mitigation



Time to

Complete

Revised

Risk

Score

13

Process

Wastewater

handling

Accidental/uncontrolled release of strong

stream effluent to weak stream system.

3

All production areas drain to weak stream effluent system.

Training of emergency response team on spill control.

WWTP influent analysed. WWTP Influent balanced/equalised prior

to treatment.

Plant Leaders

Team Leader, Safety


Ongoing /

Existing

Practice 3

15 Process waste water treatment

Failure of WWTP Process

3

Monitoring of influent and effluent to and from the WWTP.

Monitoring of WWTP process stages.


Ongoing /

Existing

Practice 3

9

Transfer of

Materials Undetected leak in piperack system.

2

Plant is manned continuously during operations. Regular area walk-downs by personnel. Minor leaks are unlikely to go unnoticed for a long period of time. Existing

controls are adequate.

Plant Leaders

Ongoing /

Existing

Practice 2

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Final

The risk matrix below remains unchanged from that presented in figure 6.7.

Table 6.8 – Risk Matrix

V. High 5 Risk ID 5, 6

High 4

Medium 3 Risk ID 17

Low 2 Risk ID 14, 16

Risk ID 1, 2, 3, 7, 12

Risk ID 11

Occu

rren

ce

V. Low 1 Risk ID 9

Risk ID 8, 10, 13, 15

Risk ID 4

1 2 3 4 5

T

rivia

l

Min

or

Mo

dera

te

Majo

r M

assiv

e

Severity

Where:

Red is a high level risk

Yellow is a medium level risk

Green (light and dark) is a low level risk

The control measures and monitoring techniques employed at the site to deal with the

risks identified were deemed adequate and these risks remain unchanged, however, this

does not take away the need for continuing awareness and monitoring on a regular basis

of these risks.

6.5.1. Quantification of Unknown Environmental Liabilities

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

costs) for the Pfizer facility was calculated through the preparation and costing of the

Residuals Management Plan (refer to Site Specific RMP).

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

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Final

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

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

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

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

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

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

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

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

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

For the Pfizer facility the worst case scenario was calculated. Table 6.10 illustrates how

the financial output for the worst case scenario is calculated.

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

Section 8 of this report.

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Final

Table 6.10 - Worst Case Scenario Financial Model

Risk

ID Potential Hazard

Occurrence

Rating

Likelihood of

Occurrence

Range

Severity

Rating

Cost Range

(€)

Worst Case

Probability

Worst Case

Severity (€)

Worst Case

Cost (€) Note 1

17 Site Closure. - - - - - - €3.8 million See note 2

11 Major Fire/Explosion. 2 5-10% 4 500,000-1,000,000

10% 1,000,000 100,000

1 Spill from loading/unloading

operations. 2 5-10% 3

100,000-500,000

10% 500,000 50,000

2 Bulk Storage tank failure. 2 5-10% 3 100,000-500,000

10% 500,000 50,000

3 Bund Integrity Failure. 2 5-10% 3 100,000-500,000

10% 500,000 50, 000

7 Failure of underground process

drainage network. 2 5-10% 3

100,000-500,000

10% 500,000 50,000

12 Power Failure 2 5-10% 3 100,000-500,000

10% 500,000 50,000

4 Improper classification/ disposal

of waste. 1 0-5% 5

>1,000,000 5% >1,000,000 50,000

5 Emissions to atmosphere in

excess of ELV’s. 5 >50% 1

<10,000 100% 10,000 10,000

6 Uncontrolled emissions of

toxic/hazardous material to air (API).

5 >50% 1 <10,000

100% 10,000 10,000

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18 June 2010

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Final

Risk

ID Potential Hazard

Occurrence

Rating

Likelihood of

Occurrence

Range

Severity

Rating

Cost Range

(€)

Worst Case

Probability

Worst Case

Severity (€)

Worst Case

Cost (€) Note 1

14 Accidental/uncontrolled release

of strong/weak stream effluent to surface water drainage system.

2 5-10% 2 10,000-100,000

10% 100,000 10,000

16 Failure of on-site environmental

control systems. 2 5-10% 2

10,000-100,000 10% 100,000 10,000

8 Major failure of aboveground

piperack. 1 0-5% 3

100,000-500,000 5% 500,000 25,000

10 Spillage of hazardous material in

production areas. 1 0-5% 3

100,000-

500,000 5% 500,000 25,000

13 Accidental/uncontrolled release

of strong stream effluent to weak stream system.

1 0-5% 3 100,000-500,000

5% 500,000 25,000

15 Failure of WWTP Process 1 0-5% 3 100,000-500,000

5% 500,000 25,000

9 Undetected leak in piperack

system. 2 5-10% 1 <10,000 10% 10,000 1,000

Total worst-case cost of unknown liabilities 541,000

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 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 sections, we discuss the financial provisions at the site and whether these

provisions are adequate to satisfactorily address the liabilities identified in section 6.

7.1. Current Financial Provisions

Pfizer Ireland Pharmaceuticals Ringaskiddy API Plant (Pfizer Ringaskiddy) is a

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

Manufacturing (PGM) division of Pfizer Inc. PGM 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

PGM 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. The company is the world’s largest pharmaceutical company and recorded

global revenues of US$50 billion in 2009.

The Pfizer Ringaskiddy manufacturing site is a cost centre within PGM 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. This budget is typically of

the order of several hundred million US dollars.

A decision to decommission all or part of the Pfizer Ringaskiddy site would be taken

centrally by Pfizer under a coordinated review. Any such decision would be announced

by Pfizer central management sufficiently in advance of implementation to allow adequate

opportunity to migrate production to alternative locations, to explore divestiture options, to

address legal and regulatory requirements, and to complete decommissioning activities

where required. Any closure decision would therefore be taken significantly in advance of

implementation.

In the event of such a decision, the site Residuals Management Plan (RMP) would be

prepared for activation. The actions detailed in the RMP would begin upon cessation of

manufacturing and preparation for closure.

It is a valid assumption that any shutdown of the site will be a well-planned and well-

resourced process. This implies that the shutdown date will be known well in advance

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18 June 2010

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Final

and that both production schedules and raw materials purchasing will be planned with the

shutdown already factored in. It also implies that Pfizer will have the resources in terms

of both financial inputs and manpower to implement the RMP through to completion, with

no requirement for external financing or manpower other than for expert advice.

Pfizer, in common with many large multinational companies, provides central funds to its

operating units through standard financial mechanisms.

Because of the likely lengthy interval between a decision to close and its actual

implementation, adequate time would be available to ensure that such an allowance for

central Pfizer funding would be incorporated into the site budget.

Consequent upon a decision to decommission all or part of the Pfizer Ringaskiddy site,

an estimate would be prepared of projected closure costs, including those costs which

may be incurred under RMP activities. This cost estimate would include those activities

required to affect closure in the short-term and also any longer term remediation and

monitoring activities if required. A detailed dossier would then be prepared for

submission to Pfizer central management and if approved, central funding would be

released by Pfizer to cover both short-term and longer-term costs as required. Such

central funding may be structured by Pfizer to stretch over several years as required to

cover longer-term activities.

In common with many multinational companies, Pfizer maintains a global public liability

insurance providing indemnity in respect of legal liabilities arising from, for example,

immediate, sudden and unforeseen discharge consequent upon an accident or due to

defective drains, sewers or sanitary arrangements. The aggregate limit set for

environmental liabilities in this respect is US$10,000,000 with no sub-limits for any

particular type of claim and no requirement for Pfizer to assume any proportion of the

costs before the indemnity applies.

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

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

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

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

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

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.

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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.

It is noteworthy that Pfizer has previously funded and completed a significant

decommissioning and remediation project on Pfizer-owned sites in Ireland (Quigley

Magnesite) and the decommissioning of another facility in the Cork area (Corrin MDA,

formerly ADM) as well as rendering safe OSP2 manufacturing facility. These examples

are directly relevant to ELRA and RMP activities and are described below:

• A speciality chemicals facility owned by Pfizer, called Quigley Magnesite, located

at Ballinacourty Point near Dungarvan, Co. Waterford, was dismantled and

decommissioned during the early 1990’s. An extensive residuals management

and remediation programme was developed and was implemented and

successfully completed over an approximately two-year period. The residuals

management work included intensive bioremediation of oil-contaminated soil at

the site. The remediated land was subsequently sold and is now occupied by a

private golf course and a wastewater treatment plant operated by Dungarvan

Urban District Council.

• The former ADM site located adjacent to the Pfizer Ringaskiddy site, now owned

by Pfizer was leased to Corrin MDA who co-ordinated the decommissioning of

the site. Pfizer Biotechnology Ireland currently operates on this land parcel.

• OSP2 facility onsite ceased manufacturing activities in Q4-2007 as part of a

business rationalisation plan to eliminate excess production capacity. The

physical building infrastructure has been retained pending future decisions as to

its potential use and the building remains part of the Pfizer Ringaskiddy site. In

2007, the OSP2 manufacturing facility was rendered safe.

These decommissioning projects were funded over the full duration of the work through

Pfizer’s central funding as described earlier.

Pfizer is committed to ensuring the highest level of environmental performance and

environmental protection in its operations, and regards this as an integral part of its

normal business practice. This includes a commitment to safe and responsible residuals

management where required. The examples provided are evidence of the company’s

past and ongoing commitment in this area, including the provision of central funding to

implement and progress any required residuals management.

Pfizer reviews its insurance and financial arrangements on a regular basis in order to

ensure ongoing and continued adequacy. Any changes or updates to such arrangements

shall be described in ELRA reviews to be submitted to the Agency.

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Final

7.2. Assessment of Pfizer Financial Provision

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

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

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

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

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

piperack systems.

Having consideration for the worst-case costs calculated in Table 6.10, a comparison of

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

unknown liabilities identified at the site.

Table 7.1 – Assessment of Pfizer Financial Provision

Risk Type Existing Pfizer Financial

Provision

Comment

Immediate, sudden and

unforeseen discharge

consequent upon an

accident.

Pfizer Global Insurance Pfizer Insurance coverage

financially adequate to cover

any liabilities identified.

Gradual unforeseen

discharge consequent upon

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.

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Final

FIGURES

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Documents

Pfizer Ireland Pharmaceuticals Ringaskiddy API Plant ... Ireland Pharmaceuticals Ringaskiddy API Plant Environmental Liabilities Risk Assessment 2010 Review Pfizer Ireland Pharmaceuticals\49340718