Pfizer Ireland Pharmaceuticals\49340718 Pfizer Ringaskiddy ELRA 2010\DURP0001/JG/JG
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
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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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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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18 June 2010
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Final
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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18 June 2010
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Final
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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Final
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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Final
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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18 June 2010
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Final
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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Final
Date Description Corrective Action
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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Final
Date Description Corrective Action
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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Final
Date Description Corrective Action
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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Final
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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Final
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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Final
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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Page 23
Final
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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Final
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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Page 25
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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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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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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Page 28
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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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.
URS Investigation 1998:
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.
URS Investigation 2000:
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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Page 30
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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Page 31
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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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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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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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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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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Final
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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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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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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Risk
ID
Process Potential Hazard Environmental Effect Occurrence
Rating
Basis of Occurrence Severity
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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Risk
ID
Process Potential Hazard Environmental Effect Occurrence
Rating
Basis of Occurrence Severity
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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Risk
ID
Process Potential Hazard Environmental Effect Occurrence
Rating
Basis of Occurrence Severity
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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Risk
ID
Process Potential Hazard Environmental Effect Occurrence
Rating
Basis of Occurrence Severity
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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Risk
ID
Process Potential Hazard Environmental Effect Occurrence
Rating
Basis of Occurrence Severity
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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18 June 2010
Page 50
Final
Risk
ID
Process Potential Hazard Environmental Effect Occurrence
Rating
Basis of Occurrence Severity
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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18 June 2010
Page 51
Final
Risk
ID
Process Potential Hazard Environmental Effect Occurrence
Rating
Basis of Occurrence Severity
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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18 June 2010
Page 52
Final
Risk
ID
Process Potential Hazard Environmental Effect Occurrence
Rating
Basis of Occurrence Severity
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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18 June 2010
Page 53
Final
Risk
ID
Process Potential Hazard Environmental Effect Occurrence
Rating
Basis of Occurrence Severity
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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18 June 2010
Page 54
Final
Risk
ID
Process Potential Hazard Environmental Effect Occurrence
Rating
Basis of Occurrence Severity
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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18 June 2010
Page 55
Final
Risk
ID
Process Potential Hazard Environmental Effect Occurrence
Rating
Basis of Occurrence Severity
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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18 June 2010
Page 56
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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18 June 2010
Page 57
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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18 June 2010
Page 58
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
Team Leader, Environment
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.
Team Leader, Environment
Ongoing / Existing Practice
6
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Page 60
Final
Risk
ID Process Potential Hazard
Risk Score
before
Mitigation
Existing/Possible Mitigation
measures Risk Manager
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.
Team Leader, Environment
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.
Team Leader, Environment
Ongoing / Existing Practice
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.
Team Leader, Environment
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
ID Process Potential Hazard
Risk Score
before
Mitigation
Existing/Possible Mitigation
measures Risk Manager
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.
Production Services Leader
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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18 June 2010
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Final
Risk
ID Process Potential Hazard
Risk Score
before
Mitigation
Existing/Possible Mitigation
measures Risk Manager
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
Production Services Leader
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.
Production Services Leader
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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18 June 2010
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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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Page 65
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
Page 66
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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Pfizer Ireland Pharmaceuticals Ringaskiddy API Plant Environmental Liabilities Risk Assessment 2010 Review
Pfizer Ireland Pharmaceuticals\49340718 Pfizer Ringaskiddy ELRA 2010\DURP0001/JG/JG
18 June 2010
Page 67
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
Page 68
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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Pfizer Ireland Pharmaceuticals Ringaskiddy API Plant Environmental Liabilities Risk Assessment 2010 Review
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Page 70
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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Page 71
Final
FIGURES
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