Attachment J - Environmental Protection Agency · a Health and Safety Management System certified to OHSAS 18001. ... As per the assessment completed for the IE licence ... These

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Attachment J

Accident Prevention & Emergency

Response

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ii

TABLE OF CONTENTS

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

2 HEALTH & SAFETY ................................................................................ 1

3 SPILL CONTAINMENT ............................................................................ 2

4 FIRE RESPONSE ..................................................................................... 3

Emergency Response Plan

Fire Water Risk Assessment

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1

1 Introduction

The following information describes the support systems on-site in the event

of an emergency with potential for environmental damage. AbbVie’s main

document covering emergencies is the Emergency Response Plan and this is

included with this attachment.

2 Health & Safety

The operation of the facility is carried out in strict accordance with all Irish and

European regulations governing safety in the work place with specific regard

to the regulations implemented under the Safety, Health & Welfare at Work

Act, 2005 (as amended). Full relevant training in the operating procedures for

equipment and processes are provided to each employee. In the case of a fire

the Emergency Response Plan will be activated and necessary personnel

have been fully trained to deal with such emergencies. AbbVie also operates

a Health and Safety Management System certified to OHSAS 18001.

Regulation in relation to the prevention of major accidents is set out in Seveso

III Directive (2012/18/EU), transposed by the Chemicals Act (Control of Major

Accident Hazards Involving Dangerous Substances) Regulations 2015 and by

the Planning and Development Regulations, 2001-2013. The Directive defines

major-accident hazard sites (COMAH sites) as those that store or could

generate quantities of dangerous substances in excess of specified

thresholds. As per the assessment completed for the IE licence application to

the EPA, Chemicals Act (Control of Major Accident Hazards Involving

Dangerous Substances) Regulations 2015 do not apply to the AbbVie facility

as storage of dangerous substances falls below the qualifying quantities for

gas oils and extremely flammable gases.

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2

3 Spill Containment

During the operation of the facility, there will be a high degree of containment

and bunding of materials on-site and no direct discharges to ground. All

production will take place exclusively within the production buildings and

loading and unloading of materials will only take place on designated hard-

standing areas.

As a requirement of the IE Licence, AbbVie will be required to maintain its

Environmental Management Programme (EMP) which will include detailed

measures for the prevention of pollutant release to the storm water drainage

system. Preventative measures which are in place at the AbbVie site include

full secondary containment (bunding) of all internal and external vessels

containing potentially polluting materials. These preventative measures will be

applied to all proposed new infrastructure as required, in the form of either

local bunding, or remote bunding. All bunds and underground process

infrastructure will be integrity tested as per EPA guidelines.

Procedures are in place for the use, handling and storage of all chemicals on-

site to ensure that the risk of spills is minimised. Training is provided to staff in

relation to the handling and storage of all chemicals on-site to ensure the risk

of spills is minimised.

Regular routine maintenance programmes are in place for the process

equipment, environmental process equipment, continuous monitors,

laboratory equipment and sampling equipment.

The emergency response teams are also trained in containment measures

with respect to spillages including procedures for containment including; use

of spill kits, spill cleaning and safe disposal of clean-up materials.

Storage areas, production facilities and roadways have impervious surfaces,

which drain to collection systems. Plant and vehicles are serviced regularly to

minimise leaks. Fuels, oils and lubricant are stored in designated bunded

areas.

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3

4 Fire Response It is AbbVie’s policy that, in the event of a fire, the safe-guarding of life takes

precedence over all other matters. AbbVie provides Emergency Response

Teams (ERT) training to all core ERT team members and conduct emergency

drills bi-annually. In the event of a fire, the Emergency Response Plan is

implemented. The plan addresses in depth the actions to be taken in the

event of a fire; gas release; bomb threat; chemical spillage and environmental

incident. It is site policy that there is always an Emergency Response Team

and Leader available to respond to an accident or incident. In the event of a

fire, the primary objectives are extinguishment and containment. Fire

detection, fire protection and firefighting equipment is provided on-site and

maintained in accordance with recognised standards. This equipment may be

outlined as follows:

Fire detection and alarm system;

Fire Hydrants;

Fire Extinguishers;

Spill Response Equipment and Materials;

Sprinkler System;

Suppression Systems;

Two way radios.

The site is serviced by Midleton Fire Brigade, based at Market Green,

Midleton, which is approximately 10 kilometres from the site. In the event of a

fire alarm being raised, travel time from this fire station to AbbVie would be

estimated to be approximately 10 minutes depending on traffic. The site’s

Emergency Response Plan states that it is responsibility of the “site incident

controller” to alert emergency services. Members of Midleton fire station have

visited AbbVie to familiarise themselves with the layout of the facility, location

of services and to offer general advice to management. The AbbVie site

typically operates 24/5, however there is a 24/7 security presence at the site.

Once an IE licence has been issued, in the event of an accident or incident,

AbbVie will notify as appropriate; the EPA, Local Authority, Fire Service,

Health Service Executive, Gardaí, Health and Safety Authority, Fisheries

Board, Sanitary Authority, Food Safety Authority and/or Harbour Masters, of

all incidents relating to the environment. Approval and guidance from the EPA

will be sought prior to the disposal of materials and retained fire water.

A fire-water risk assessment undertaken in July 2016 has concluded that,

based on the assessment and the EPA’s Guidance Note, firewater retention

facilities for the AbbVie site at Carrigtwohill, Co Cork are not required. This

report in full has been appended to this attachment.

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Emergency Response Plan

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Document applies to the following areas:

Department

Name:

Yes = No = x Department

Name:

Yes = No = x

Quality Assurance Engineering

Quality Control Finance

EHSE HR

Regulatory Affairs IT

Site Technology Supply Chain

Production

1. OBJECTIVE

The purpose of this Plan is to ensure that all company personnel are informed of the correct actions

to be taken in the event of an emergency and to ensure that efforts in response to an emergency are

organised and co-ordinated so that it may be brought under control with minimum risk to personnel,

property or the environment.

The Emergency Procedures detailed in this document are a main component of the sites Business

Continuity Plan (BCP).

In the event of a Significant Incident; Senior Management will refer to the BCP.

2. APPLICABLE DOCUMENTS

DOCUMENT NUMBER DOCUMENT TITLE

N/A Safety Statement & Standards Manual

N/A Employee Handbook

N/A BCP (Business Continuity Plan)

N/A Synergy Security Assignment Instructions

CK-EHSE-0000145209 EHS&E Near Miss & Incident Reporting

& Investigation Procedure

CK-EHSE-0000145210 EHS&E Regulatory Reporting

CK-EHSE-0000515295 EHS&E Visitor & Contractor

Management Programme Procedure

SOLID 0000145216 Control And Maintenance Of The Fire

Detection System

CK-EHSE-0000145220 Electing Site Safety Representative

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CK-EHSE-0000145222 Operating Instructions for the Orwak

Balers, DMR Compactor and Dechimber

CK-EHSE-0000167248 Procedure for Man Down Alarms

CK-EHSE-0000506844 EHS&E Manual Handling Training

Procedure

CK-EHSE-0000506845 EHS&E Risk Assessment Procedure for

Pregnant, Post Natal & Breastfeeding

Employees

CK-EHSE-0000506846 EHS&E Setting Objectives, Targets and

Programs

CK-EHSE-0000506848 EHS&E Communications, Participation

and Consultation Procedure

CK-EHSE-0000506849 EHS&E Identification, Control and

Compliance with Legislation and other

Requirements

CK-EHSE-0000506850 EHS&E Internal Audit Procedure

CK-EHSE-0000506851 EHS&E Management Review

CK-EHSE-0000506852 EHS&E Monitoring & Measurement

Procedure

CK-EHSE-0000506853 EHS&E Hazard Identification, Risk

Assessment and Risk Control Procedure

CK-EHSE-0000507694 EHS&E Management of Change

CK-EHSE-0000508566 EHS&E Identification of Aspects and

Evaluation of Impacts

3. ABBREVIATIONS

TERM DEFINITION

SOP Standard Operating Procedure

BCP Business Continuity Plan ERP Emergency Response Plan

EHS&E Environmental, Health, Safety & Energy

ISO International Organisation for Standards

OHSAS Occupational Health and Safety

Assessment Series

BGU Break Glass Unit

ERT Leader Emergency Response Team Leader

ERT Emergency Response Team

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SIC Site Incident Controller

4. ENVIRONMENTAL HEALTH & SAFETY

This plan applies to a number of credible situations, primarily those which may interrupt normal

operations, require an immediate co-ordinated management response and finally, whereby an event

has the potential to focus media and public attention on the activities of the organisation.

The responses to each defined circumstances have been reviewed in accordance with the specific

elements of ISO 14001: 2004 (4.4.7 of the Environmental Management Standard) OHSAS 18001:

2007 (4.4.7 of the Occupational, Health & Safety Management Standard) and the specific elements

of the ISO 50001: 2011 Energy Management Standard.

Subsequently, the company has identified a broad range of emergency situations presenting a risk to

the company.

These areas are as follows:-

Environmental Risk

Physical Security Risk

Stock Interruption risk

Social emergency

Information technology emergency

Information leak

Public health.

In the context of this Plan, an Emergency is defined as ‘an unplanned event/incident requiring the

evacuation of personnel from all or part of the site or require containment/action on an

environmental incident, which may significantly affect site operations and / or personnel and / or the

environment’.

An emergency response may be declared in any of the following events :-

Fire

Explosion / Loss of containment

Gas release

Serious Danger (immediate / delay, inside / outside)

Bomb Threat / Warning (Animal Rights Activists)

Major Chemical spillage

Pandemic

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Any of the above events may result in the Emergency Response Plan being implemented. This

plan addresses in depth the actions to be taken in the event of a fire; gas release; bomb threat;

chemical spillage and environmental incident. An evacuation of the site may not be warranted in

the event of a social crisis, for example, but will in effect result in a number of members of the

Emergency Management Team convening.

Note: To avoid confusion for future Regulatory, Corporate and Independent Audits, AbbVie has

been used as the Company name in this Procedure instead of the legal trading name; Fournier

Laboratories Ireland Ltd. (FLI).

5. ATTACHMENTS

There are 7 attachments to this procedure.

ATTACHMENT NUMBER TITLE

Attachment 1 (1 page) Incident Emergency Log

Attachment 2 (1 page) Emergency Evacuation Roles & Responsibilities

Attachment 3 (2 pages) Emergency Response Contact Information

Attachment 4 (1 page) Emergency Response Equipment

Attachment 5 (2 pages) Emergency Bomb Threat Form

Attachment 6 (1 page) Pandemic Influenza Questionnaire for Personnel

Travelling from Abroad

Attachment 7 (1 page) Emergency Evacuation Checklist

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TABLE OF CONTENTS

SECTION PAGE(S)

1.0 Objective 1

2.0 Applicable Documents 1-2

3.0 Abbreviations 2-3

4.0 Environmental, Health & Safety 3-4

5.0 Attachments 4

Table Of Contents 5

6.1 Emergency Response Organisation Structure 5-6

Table 1: - Roles & Responsibilities of the Emergency Response Team 6-8

6.2 Emergency Response Procedures 8-9

6.2.1. First Knock Response & Alarm Investigation Procedure 9-10

6.3 Emergency Response Procedures - Fire. Normal Office Hours 10-21

6.4 Emergency Response Procedures – Outside Normal Office Hours 21-27

6.5 Emergency Response Procedures – Threat 27-30

6.6 Response Procedure – Animal Rights Activists 30-31

6.7 Escape Of Natural Gas 31

6.8 Major Chemical Spillage On-Site 31-34

6.9 Pandemic Preparedness 35-40

6.10 Environmental Protection 41

6.11 Resources 42-43

7.0 Revision 43-44

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6. PROCEDURE

6.1. EMERGENCY RESPONSE ORGANISATION STRUCTURE

6.1.1. General

The Emergency Response Organisation Structure is included below. Depending on the nature

and severity of the emergency situation, the Site Incident Controller may appoint additional

individuals to assist and support the Emergency Response Team.

6.1.2. Roles

Personnel who are designated to fill the Emergency Response Plan roles are listed at

Attachment 2 to this Plan.

Figure 1: Emergency Response Structure

Site Incident Controller

ERT Members/

Fire Marshals

First Aiders

Event Recorder

Security

ERT Leader

Roll Call

Officers

Sprinkler System

Controller

First Aid

Co-ordinator

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6.1.3. External Emergency Services

The company recognises the limitations of its internal emergency response capability and

consequently the need to summon immediate assistance from the External Emergency Services.

The company is aware that the Officer in Charge of the Fire Services takes overall control of all

fire fighting activities on arrival at the scene.

6.1.4. Responsibilities

The responsibilities, as described hereunder in Table 1, are intended to supplement the good

judgement and experience of the various appointment holders. The Site Incident Controller may

assign responsibilities in addition to those outlined hereunder depending on the actual

circumstances of the emergency.

Table 1: - Roles & Responsibilities of the Emergency Response Team

ROLE RESPONSIBILITIES

Site Incident

Controller Directing and co-ordinating the activities of the Emergency Response Team.

Liaison with, and assisting, the External Emergency Services.

Keeping senior management informed of the situation.

Ensuring that a written record of events is maintained.

Ensuring that all personnel on site are accounted for.

Controlling all personnel at the Assembly Points.

Security Ensuring that the site information files are readily available.

Distributing the designated two-way radios.

Distributing the muster list to the appropriate assembly area coordinators.

Contacting external emergency services and other agencies/organisations as

directed by the Site Incident Controller and other member of the Emergency

Response Team.

Updating the Emergency organisation Chart on a daily basis

Recording the details of threatening phone calls to the site

ERT Leader Directing and co-ordinating the activities of the ERT members.

Reporting events to Site Incident Controller.

ERT Members /

Fire Marshals Investigating the cause of the emergency.

Reporting events to ERT leader.

Ensuring that personnel are evacuating from their area of responsibility.

Searching the area of responsibility during evacuation.

Sprinkler

System

Controller

In the event of an emergency requiring the activation of the sprinkler system

the sprinkler system controller will isolate and shut off control valves and

pumps in consultation with the ERT Leader, the SIC and the emergency

services.

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Roll Call Officer Ensuring evacuation areas and all personnel therein are accounted for

Reporting any missing persons to the Site Incident Controller.

First Aid

Co-ordinator Assembling First Aid Personnel.

Ensuring that First Aid is rendered as necessary.

Liaison with the Ambulance Service, Company Doctor and/or Medical

Services.

Prepares first aid equipment and paramedic boxes.

Prepares first aid safe lay down area.

Co-ordinates the response to the first aid unit.

First

Aid Personnel Rendering First Aid.

Carrying out instructions as directed by the First Aid Co-ordinator.

Event Recorder

Compiles history of events as they unfold.

Note: Who and which organisations have contacted the site seeking

information on the incident.

Note: What commitments have been given in relation to public information?

6.1.5. Daily Incident Response Team

Before the commencement of normal office hours each day, personnel are nominated to fill

the various roles as described in the ‘Daily Incident Response Team, which is located in the

security area.

The compilation of the ‘Daily Incident Response Team’ will ensure that a confirmed

emergency response capability exists and that there is an immediate and co-ordinated

response in the event of an emergency.

It is the responsibility of Security to update the Incident Response Team Chart on a Daily

basis.

6.1.6. Outside Normal Office Hours

If an emergency occurs outside normal office hours, then the Production Shift Supervisor will

assume the role of Site Incident Controller and will follow the procedures as described in

Section 6.3.2 of this Plan.

6.2. EMERGENCY RESPONSE PROCEDURES

The actions as described in Section 6.3 of this Plan are primarily concerned with the actions to

be carried out should a Fire occur on site. Although the focus is on Fire, this set of emergency

response actions and the emergency response organisation as described in

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Section 6.1.1 of this Plan provides an effective framework to enable the company to respond to

other emergency situations that may occur.

Notwithstanding the above, the company recognises that emergency situations other than fire

may demand different or additional responses and that an emergency may occur outside of

normal office hours and at weekends. In this regard, emergency actions have been developed

for the following:

Major Emission e.g. escape gas

Fire

Bomb Threat / Warning

Major Chemical spillage

Any of the above events may result in the Emergency Response Plan being implemented.

6.2.1. FIRST KNOCK RESPONSE & ALARM INVESTIGATION PROCEDURE

During Normal Business Hours

If the alarm is activated (first knock), ERT members will go to the repeater panel located

beside the maintenance office in the main corridor.

One member of the team will make contact with the security officer on duty.

This person will remain at the panel in contact with the security officer.

A minimum of 2 other ERT members will investigate the activation based on the information

displayed on the panel; points and zone details etc.

If it is discovered that the activation is a false alarm, the ERT team leader will silence the

alarm and take the appropriate action to rectify the situation, discover the root cause, record

his findings and submit these to the ERT team, Security, the SIC and if necessary the Site

Director and the senior management team.

If the alarm is deactivated at the first knock level, a member of the ERT or security will make

an appropriate announcement detailing the reason for the activation.

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If the activation is found to be a genuine alarm condition, the ERT member at the repeater

panel will activate the general alarm to evacuate the building, in advance of the system

progressing to this stage.

At this stage all personnel will assemble at the evacuation assembly area and await further

instruction.

Outside Normal Office Hours

If the alarm is activated (first knock), an ERT member and/or maintenance technician will go

to the repeater panel located beside the maintenance office in the main corridor.

He will make contact with the security officer on duty.

The production supervisor on duty will also go to the repeater panel.

An investigation will be carried out and the best course of action will be determined in line

with the steps detailed above.

An investigation can only be carried out by 2 people, one of whom must be an ERT member.

6.3. EMERGENCY RESPONSE PROCEDURES - FIRE. NORMAL OFFICE HOURS

6.3.1. STAFF MEMBERS

Important:

The actions, described hereunder, should be carried out, only if it is safe to do so, and, if

you have been trained to do so.

Do not take any risks which could threaten your safety or the safety of others.

On discovery of a fire:

1. Alert all occupants in the immediate vicinity to the danger.

2. Go to the nearest Break Glass Unit (BGU) and sound the evacuation siren.

3. Alert your Supervisor and/or Fire Marshal, if safe to do so.

4. In the event of a minor fire, try to contain it using the appropriate extinguisher only if is

safe to do so and never on your own. Attack the fire without delay, as speed is essential

when dealing with a small fire.

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Note: Remain on the exit side of the fire.

5. If you are no longer able to contain the fire then vacate the building immediately by the

nearest Clear Exit. If it is safe to do so close all doors behind you, in order to prevent the

spread of smoke and fumes.

6. Report to your Site Incident Controller at your Assembly Point and inform him/her of the

situation at the scene of the incident, outlining how far advanced the fire was as you left

it.

7. Remain at your Assembly Point and follow the instructions of your Site Incident

Controller.

8. Do not leave your Evacuation Point unless given the all clear.

On hearing the fire alarm or if an evacuation of the facility is ordered:

1. Evacuate the building by the nearest Clear Exit.

2. Close all doors behind you, if it is safe to do so.

3. Report to your Assembly Point and assist in establishing the whereabouts of persons who

are not accounted for.


Controller.

5. Do not leave your Evacuation Point unless given the all clear.

Assembly Points

The Evacuation Assembly Points are located at the entrance to the site near the security

building. These areas are marked out by green signs and when the alarm sounds or an

evacuation of the site is ordered, staff will report to their respective areas as detailed

hereunder. Each area has its own Role call officer (and in his/her absence there are

designated substitutes). It is their responsibility to account for staff in their area and to

report the results of the roll call to the Site Incident Controller.

Note: Contractors and visitors evacuate within the same area but a specifically assigned

location.

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6.3.2. SITE INCIDENT CONTROLLERS

Important:



Do not take any risks which could threaten your own safety or the safety of others.

On hearing the alarm or on being notified of the occurrence of an incident:

1. Evacuate to the assembly areas by the nearest clear exit.

2. Collect a walkie-talkie from the Security guard.

3. Ensure that all members of the Emergency Response Team are alerted.

4. Appoint an Event Recorder and instruct him/her to maintain a written record of

events (An ‘Incident Emergency log’ is attached as Attachment 1 to this Plan).

5. Establish contact with the ERT Leader by walkie-talkie. Determine the cause of

alarm activation and/or location of the incident.

6. If the alarm is as a result of any of those listed in section 4, instruct for the Fire /

Emergency service to be called and maintain communication as required.

7. If any staff / visitors or contractors are unaccounted for after the Roll Call, notify

the ERT Leader and provide him with as much information as is available.

Instruct him to organise a search of the site in order to locate the missing

person(s) (priority to be given to establishing an accurate evacuation status of the

site).

8. If the ERT Leader confirms that the cause of alarm activation was fire, then

instruct the Security Guard to call the Fire Service / Emergency Service

immediately. If additional pertinent information in regard to the incident becomes

available then ensure that the Emergency Services are updated, even though they

may only be on route to the site.

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9. If necessary, appoint staff as Traffic Controllers to ensure that there is easy access

to the site and to the scene of the incident for the Emergency Services when they

arrive. Control access to the site throughout the perimeter.

10. Ensure that every support and assistance is provided to the ERT in regard to:

Chemical safety and chemical hazard avoidance.

Making safe plant and equipment.

Isolation of services / utilities.

11. If casualties are reported ensure that the Ambulance Service is called via (Security

Guard) and that first aid is arranged (First Aid Co-ordinator).

12. Ensure that all personnel are moved to the safest area (e.g. upwind of smoke, to the

car park or to an off-site location or to the canteen depending on the nature of the

incident and your assessment of the risk to which staff are exposed).

13. Following consultation with the General Manager, ensure that the relevant people

in Corporate are contacted.

14. Meet with, and brief the Officer in Charge of the Fire Service when he arrives on

site. The Officer in Charge of the Fire Service will require information in regard

to the following:

Evacuation Status of Site (includes missing persons and/or casualties and

their whereabouts, if known).

Nature and Location of Fire (person who discovered the incident will be

very helpful in providing this information).

Fire Suppression Systems (includes pumps and isolation devices).

Location of Water Sources (hydrants, wet and dry mains and any other

available sources).

Isolation of Services/Utilities (electricity, gas, ventilation etc.).

Special hazards (chemicals, fuels etc. – including quantities, hazardous

properties and the nature of effects on man and the environment and an

outline of the use and storage of the materials on site).

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Environmental Protection Measures (collection and storage of hazardous

material and firewater.

Material Safety Data Sheets

Site Map Drawings

Access to buildings

Salvage Priorities

Salvage Priorities.

When briefing the Officer in Charge of the Fire Services use the information pack

(at the ERT Command Centre), which at a minimum contains the following

information:

Site Drawings

List of Key Personnel

MSDS Files

15. If required ensure that the following personnel are available to assist / support /

advise the Officer in Charge:

Person who discovered the incident.

Production personnel with a detailed knowledge of chemicals (hazard and

hazard avoidance) and processes

Maintenance personnel with knowledge of plant and services/utilities.

EHS&E personnel with knowledge of environmental, health and safety

protection measures.

16. Ensure that the First Aid Co-ordinator meets the Ambulance Service when they

arrive.

17. Ensure that the EHS&E Manager is advised in regard to possible notification of

the incident to the Health and Safety Authority, Cork County Council, South

Western Regional Fisheries Board.

18. In consultation with the Officer in Charge of the Fire Service, issue the ‘ALL

CLEAR’ for re-entry to buildings.

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19. Initiate restoration and clean-up activities. This may require the assistance of

external specialist contractors.

20. Compile an incident / accident report where applicable.

6.3.3. SECURITY GUARD

Important:




On hearing the alarm:

1. Distributing the designated two-way radios to the SIC, ERT lead and the ERT. The

Security Guard will keep one two way radio.

2. Collect the print out (muster list) of staff TMS system and distribute to all nominated

parties.

In relation to dealing with Contractors and Visitors, the muster list; whether hand

written or electronic, will be controlled and checked by the Security guard on duty.

3. If called upon to do so, the Security guard will distribute the evacuation muster list.

4. Collect the Emergency pack from security. Make sure that it is available should the

emergency services arrive on site.

5. Evacuate to the assembly area.

6. Do not call the Fire Brigade unless instructed to do so by the Site Incident Controller.

7. Call the Ambulance Service and Company Doctor only if instructed to do so by the

Site Incident Controller

8. Deal with incoming routine calls using the following statement:

“We are unable to deal with your call at present. If you would like to leave your name,

organisation, telephone number, I shall ensure your message is passed on to the

appropriate person”.

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Do not delay. Telephone lines must be kept free for incoming and outgoing

emergency calls.

Directions for Fire Brigade from Midleton First Emergency Response Unit followed by Cobh and finally the city.

Turn immediately right on existing Middleton Fire Station; go to the roundabout; take

the fourth exit, onto the Old Cork road, take the second left into the N25 towards Cork.

From the dual carriage way take the second slip road sign posted Carrigtwohill &

Cobh, at the roundabout take the first exit. At the immediate following roundabout

take the third exit.

Early Morning / Rush hour: As Above

6.3.4. ROLL CALL OFFICER

Important:




On hearing the alarm, or if an evacuation of the site is ordered:

1. Go immediately to the Assembly Point(s)

2. Carry out a Roll Call and account for those personnel for whom you are responsible.

3. Give a situation report to the Site Incident Controller regarding the results of your roll

call.

4. Ensure that personnel for whom you are responsible remain at their Assembly Point

unless otherwise directed by the Site Incident Controller.

Only the Site Incident Controller has the authority to issue the ALL CLEAR and

instruct personnel to return to work.

5. Carry out any other tasks as directed by the Senior Roll Call Officer.

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6.3.5. FIRST AID CO-ORDINATOR

Important:





1. Go to your Assembly Point and ensure that you are accounted for immediately.

2. Inform the Site Incident Controller of your whereabouts

3. Prepare whatever number of First Aiders are available among evacuated staff to

assist in dealing with casualties should there be any.

4. Respond to the situation as directed by the Site Incident Controller.

5. Prepare a lay down area for causalities; this needs to be up wind of any potential

fumes and smoke.

In the event of a major emergency and casualties being reported:

1. Ensure that the Security Guard contacts the Company Doctor and the Ambulance

Service.

2. Proceed to the area where casualties have been reported.

3. Assess the casualty situation and call on additional First Aiders as required as well

as organising for them to bring the necessary equipment to the scene.

4. Organise appropriate and adequate treatment on a priority basis.

5. Arrange for the casualties to be moved, where possible, to a secure and safe

location.

6. Organise for ongoing treatment of casualties as required.

7. Liaise with the Personnel Officer and provide details in regard to casualties to

him/her.

8. Once the Company Doctor and/or Ambulance Services are on-site, pass over a

detailed report outlining all injuries and any First Aid given to any Casualty. This

should be reported directly and not over the walkie-talkie circuit.

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9. If casualties are evacuated to hospital, ensure that you record the following details

and that you provide such details to the Site Incident Controller:

Name(s) of casualty(s).

Nature of the casualty(s) injuries.

Hospital to which the casualty(s) have been taken.

Point of contact in hospital.

10. If any causality is evacuated to hospital are affected by exposure to chemicals

ensure that copies of the relevant MSDS’s (Material Safety Data Sheets)

accompany them to the hospital.

6.3.6. FIRST AID PERSONNEL

Important:





1. Go to your Assembly Point and ensure that the relevant Roll call officer

accounts you for immediately.

2. Carry out instructions as directed by the First Aid Co-ordinator.

3. However, if instructed to do so by the SIC, go to the appropriate safe casualty area

and administer First Aid as required.

4. Report Casualty details to either the First Aid Co-ordinator or the SIC.

6.3.7. EVENT LOGGER

1. Gather information on the situation from the Site Incident Controller, First Aid

Co-ordinator and record details as in the Incident Emergency Log as in

Attachment 1.

2. Precise details emphasising times of events & event details, as well as recording

details of commitments given to outside bodies for information must be recorded

in the Incident / Emergency Log as in Attachment I. This information could be

critical in the aftermath.

3. The event logger should also assist the Site Incident Controller by relaying

information such as repeating details already given etc.

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6.3.8. ERT LEADER

Important:





1. Go immediately to the Security Building and establish contact with the Site

Incident Controller, via walkie-talkie. Once you have established contact with the

Site Incident Controller:

View the Fire Alarm Panel in the Security area first, as it may not be safe to

enter the plant floor area if the release is related to the fire suppression system.

Discuss a plan of action with the Site Incident Controller.

2. Brief the ERT members in regard to the location and nature of the incident.

3. Give a status check on the ERT members to the Site Incident controller.

4. Begin directing ERT operations. If you require information/advice in regard to

the following then contact the Site Incident Controller:

Chemical Hazards and Chemical Hazard avoidance.

Environmental protection measures

(e.g. for treatment of contaminated water run-off)

5. Maintain contact with the Site Incident Controller as the situation develops.

Note: The ERT Leader’s role is to direct and co-ordinate the actions of the ERT

members only.

6. Gather as much information as possible in regard to the incident in order to

direct the ERT as efficiently as possible and in order to assist the Emergency

Service.

7. Once the Fire Services have arrived on-site, the attendant Fire Officer will

assume control of all operations, as is their right. The ERT will then act

under his instructions.

8. Provide all necessary assistance to the Fire Services while they are on-site.

9. Accept control of the site back from the Emergency Services one they leave the

site.

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10. Initiate clean-up activities as directed by the Site Incident Controller.

11. Assist the Site Controller in the compilation of the incident report.

6.3.9. EMERGENCY RESPONSE TEAM

Important:





1. Go immediately to the Security Area.

2. Collect the ERT Walkie-talkie(s).

3. Remain at Security until the ERT Leader arrives.

4. Carry out tasks as directed by the ERT Leader:

5. The ERT follows the ERT Leaders instructions at all times.

6. On the discovery of any casualty, inform the ERT Leader of the need for First Aid

assistance. Where possible remove the casualty to a safe place for treatment.

Remain with the casualty until a First Aider arrives to the Casualty and begins to

treat the casualty.

7. Stand by for further orders.

8. Assist the Fire Services when they arrive on site as directed by the ERT Leader.

6.3.10. SPRINKLER SYSTEM CONTROLLER

Important:

The actions, described hereunder, should be carried out, only if it is safe to do so,

and, if you have been trained to do so.


In the event of an emergency requiring the activation of the sprinkler system the

sprinkler system controller will isolate and shutoff control valves and pumps in

consultation with the ERT Leader, the SIC and the emergency services. This person will

be appointed as the emergency or situation changes. All of the ERT can perform the duties of

the Sprinkler Controller and have received the appropriate training as part of their

maintenance/PM duties.

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1. Go immediately to the Security Area.

2. Collect the ERT Walkie-talkie(s).

3. Remain at Security until the ERT Leader arrives.


5. Assist the Fire Services when they arrive on site as directed by the ERT Leader

6. The Valve Controller follows the ERT Leaders instructions at all times.

7. The system consists of local isolating valves; ICV1 and ICV 2 and their associated

risers which control the distribution of water into 2 separate zones. Zone 1 is

everything west of reception, Zone 2 is east.

If it is a genuine fire; check that the system is supplying water.

Check that the system is maintaining the required pressure, (gauges on the risers).

Verify which pump is running; depending on the nature of the fire consult with

the ERT leader and the emergency services to decide if the most appropriate

pump for the type of fire is running.

Once the fire is under control and extinguished, if advised by the SIC and ERT

leader in consultation with emergency services, repair any impairments to the

system and validate the integrity of the system.

In the event of a broken or defective sprinkler head, identify the affected zone and

isolate the riser for that zone; Stop the fire pump and drain the zone via the 2 inch

drain line. Repair/replace defective head. De-isolate/re-open closed valve to refill

the system and carry out the 2 inch drop test.

As soon as possible, and if required, inform FM Global of the impairment and any

other pertinent details.


6.4. EMERGENCY RESPONSE PROCEDURES – OUTSIDE NORMAL OFFICE HOURS

6.4.1. GENERAL

If an emergency occurs outside normal office hours (17:00 to 0800) or during the

weekend SECURITY will assume the role of Site Incident Controller, (if a nominated

Site Incident Controller is not on site), and will follow

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the procedures as described below. Prior to the commencement of each shift, the Shift

Supervisor will ensure that he is aware of the identity of the Manager on Call and that the

ERT is nominated. The shift Team lead will assume the roll of Emergency Response

Team lead and follow the procedures as described below.

Figure 2: Emergency Call Out Procedure - Outside normal office hours

Emergency

Response

Team

PRODUCTION SUPERVISOR SECURITY GUARD

Emergency

Response

Team Leader

Shift Maintenance

Technician

CALLS

]

CALLS

Site Senior

Management Team

Site Incident

Controller

]

CALLS

Senior Managers

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EMERGENCY CALL OUT PROCEDURE

An Emergency Event: Fire, Flooding, Major Storm Damage

Unauthorised Access, any event that puts personnel at risk, property damage or adulterates the

production process

Priority 1: Personnel

Priority 2: Facility

Priority 3: Product

In the event of site emergency event outside of normal

working hours (08:00 – 17:00) the following call out procedure is to be implemented.

(ALL CASES)

Notify on-site Maintenance Technician

Maintenance Technician evaluates site risk (personnel, property and product).

In the event to risk to personnel and/or property call emergency services and follow escalation

process

Escalation Level 1

Maintenance Technician to call Maintenance Supervisor

Escalation Level 2

Maintenance Supervisor evaluates risk and calls EHS&E

or Managing Director

Escalation Level 3

Site Incident Controller implements Emergency Response Plan

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6.4.2. SITE INCIDENT CONTROLLER (Security)

Important:





1. Go immediately to Security and don identity fluorescent over-garment.

2. Collect SIC Walkie-talkie.

3. View the Fire Alarm Panel and in conjunction with the Security Guard/ERT

Leader/ERT discuss a plan of action with him.

Note: The main Fire Alarm Panel is located in the Plant Floor, which may also be

viewed at the security if access to the Plant room is not possible.

4. Go to the Assembly Points area and ensure that all personnel on-site are

accounted, including staff, contractors and visitors.

(Refer to Notes 2 & 3 below).

Note 2: Staff

On hearing the alarm, staff evacuate to their Assembly Points. Outside normal office

hours (17:00 to 08:00), the Production supervisor must account for staff using the TMS

FOB System Print out of staff remaining on site and TMS and Contractor/visitor log book

or the Frontdoor security visitors and contractors screen.

Note 3: Contractors and Visitors

Contractors and Visitors evacuate to their Assembly Points. A badge system is in place

for Contractors and Visitors.

Visitors and contractors are controlled and managed using the Frontdoor system. The

Frontdoor system is an electronic Visitor notification and Contractor permit to work

system which is used to book in a visitor to the site and create work permits which are,

sponsored locally by the person requiring the work to be carried out and, and approved by

the EHS&E Manager or an equivalent counterpart set up on the system as an approver of

permits. The visitor’s details and the approved permits can be viewed, downloaded and

printed.

When Contractors and Visitors arrive on site they are required to report to security where

they are issued with a badge and details such as their time on-site and their company

contact is recorded in a Log Book. Their departure from the site is also recorded in this

Log Book. Information from this Log Book is transferred to security after 1700 hours

listing remaining Contractors and Visitors on site. As people depart the site after 1700,

they sign themselves on this sheet and leave their badge at security. This Log Book and

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associated sheet (Contractors and Visitors List) is used to call the roll for Contractors and

Visitors.

1. Appoint an Event Recorder and instruct him/her to maintain a written record of

events (an ‘Incident Emergency Log’ is attached as Attachment I to this Plan).

One of the shift technicians can fulfil this role.

2. If necessary, organise a search and rescue party with the ERT.

3. If deemed necessary call the Fire Services

4. Observe the development of the incident and determine the need to move

assembled personnel to a safe location i.e. upwind of smoke and fumes.

5. If a false alarm has occurred issue the ALL CLEAR and instruct personnel to

return to work.

6. Note: Only the Site Incident Controller (or the Shift Supervisor) has the

authority to issue the ALL CLEAR and instruct personnel to return to work.

7. If it is a genuine alarm then carry out the following procedures.

8. Call the Company Doctor, Ambulance Service and Gardaí as necessary.

9. Inform neighbouring companies of the situation as deemed necessary or as

directed by management. All emergency telephone numbers are available on the

Emergency Response Contact Information, a copy of which is available in the

Security Folder (also at Attachment 3 to this Plan).

10. Ensure the appropriate information and documentation is readily available for the

Emergency Services when they arrive on site: such as Material Safety Data Sheets

and Site Drawings etc.

11. Update yourself with the situation by maintaining contact with the Emergency

Response team by Walkie–Talkie.

12. Meet with, and brief, the Emergency Services when they arrive on site. Use the

documentation as described previously and ensure that the ERT Leader is

available to assist. The Officer in Charge will require information in regard to the

following:

Evacuation Status of Site (includes missing persons and/or casualties and

their whereabouts, if known).

Nature and Location of Fire (person who discovered the incident will be

very helpful in providing this information).

Fire Suppression Systems (includes pumps and isolation devices).

Location of Water Sources (hydrants, wet and dry mains and any other

available sources).

Isolation of Services/Utilities (electricity, gas, ventilation etc.).

Special hazards (chemicals, fuels etc. – including quantities, hazardous

properties and the nature of effects on man and the environment and an

outline of the use and storage of the materials on site).

Environmental Protection Measures (collection & storage of hazardous

material & fire water).

Access to buildings.

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Salvage Priorities.

Site drawing.

Material Safety Data Sheets.

Note: The Officer in Charge of the Fire Services takes control over all fire

fighting

activities when the Fire Services arrive.

13. Provide assistance to the Officer in Charge while the Fire Services are on

site.

14. Brief management when they arrive on site.

15. Assist with the compilation of an incident report.

6.4.3. ERT LEADER

Important:





1. Go immediately to the Security and establish contact with the Site Incident

Controller, via walkie-talkie. Once you have established contact with the Site

Incident Controller:

View the Fire Alarm Panel in the Security area first, as it may not be safe to

enter the plant floor area if the release is related to the fire suppression

system. Discuss a plan of action with the Site Incident Controller.

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2. Brief the ERT members in regard to the location and nature of the incident.

3. Give a status check on the ERT members to the Site Incident controller.

4. Begin directing ERT operations. If you require information/advice in regard to

the following then contact the Site Incident Controller:


Environmental protection measures (e.g. for treatment of contaminated water

run-off)


Note: The ERT Leader’s role is to direct and co-ordinate the actions of the ERT

members only.



Service

7. Once the Fire Services have arrived on-site, the attendant Fire Officer will assume

control of all operations, as is their right. The AbbVie ERT Leader and ERT will

then act under his instructions.

8. Provide assistance to the Fire Services while they are on-site.

9. Accept control of the site back from the Emergency Services once they leave the

site.

10. Initiate clean-up activities as directed by the Site Incident Controller.

11. Assist the Site Controller in compilation of an incident report

6.5. EMERGENCY RESPONSE PROCEDURES – THREAT

6.5.1. GENERAL – Bomb threats

Bomb threats may be received by telephone; letter or notes left in conspicuous places and

can be an effective means of disrupting business. The response to a bomb threat will be

handled in a similar manner as for any other emergency as detailed in this Emergency

Response Plan. There are, however, some specific details required in the case of a bomb

threat, which are described in this Section of the Plan. All bomb threats should be treated

as bona fide and should not be regarded as hoaxes.

6.5.2. ACTION BY RECIPIENT OF THREAT

The Security Guards are the most likely persons to receive the call, but any member of

staff who has a direct line might also receive a threat. The recipient of the call should

carry out the following actions. Similar procedures should be followed if the threat is

received by letter or by notes left in conspicuous places:

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1. Remain calm and allow the caller to finish his/her message without interruption.

2. After the caller has given his/her message, try to keep the caller in conversation

for as long as possible, and if possible, ensure that the information as detailed in

‘CHECKLIST - WHAT TO DO IF YOU RECEIVE A TELEPHONE BOMB

THREAT’ is obtained. This Checklist is attached as part of this plan, Section

6.5.4.

3. Keep the line open even when the caller has hung up - i.e. do not replace your

telephone handset.

Note: A copy of the above mentioned Checklist should be located by the telephones, at

the Security building and at all direct line users.

4. Contact the Site Controller (refer to emergency notice board at reception)

immediately. Do not forget to bring the Checklist as per section 6.4 with you if

you have to leave your work desk.

Note: If outside normal working hours or at weekends, then the Shift Supervisor or

Security Officer should contact the Manager on Call or a member of

management and then carry out the procedures as described hereunder at

Section 6.5.3

6.5.3. SITE INCIDENT CONTROLLER

1. If details received in regard to the bomb/device are unclear then contact the

Gardaí and give them as much detail as is available. You should have the

recipient of the call at your side in case the Gardaí wish to speak with that person.

Follow the advice of the Gardaí, which may include evacuation.

2. If the caller has given precise details in regard to the location of the bomb/device

and indicated that the bomb is likely to explode imminently, then initiate

evacuation immediately. If time permits alert the Fire Marshals and

Management to the reason for evacuation and advise them to direct personnel

away from the suspect bomb / device and to instruct personnel to bring their

personal belongings with them.

3. Once all staff members have been accounted for at their Assembly Points, instruct

them to move to an alternative location not less than 400 metres away from the

affected building.

4. Alert neighbouring industries and local residents to the danger and provide them

with details of what has happened and what actions you have taken.

5. Once the Gardaí have arrived in the area, hand over control to them until they give

the “ALL CLEAR” that the building is safe to re-occupy. They will cordon off the

area in order to control the movement of people and vehicles. Every assistance

should be provided to them in regard to:

Searching for the suspect bomb/device.

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Evaluation of the threat (the completed ‘CHECKLIST’ and the recipient of

the call will be very helpful in this regard) which should include:

Text of message.

Caller’s approximate age.

Specific characteristics of the threat.

Current labour problems, if any.

Recently dismissed, disciplined, or disaffected employees.

6.5.4. CHECKLIST – TELEPHONE THREAT

Checklist - What to do if You Receive a Telephone Bomb Threat

If possible, tell someone else immediately so that they can tell the Site Incident Controller,

but do not put down the handset or stop the conversation.

Ask the caller which town or area they are speaking from.

Try to keep the caller talking (apologise for a bad phone line, ask him or her to speak up,

and so on). Get as much information as you can.

Fill in the form as in Attachment 5. Ask the questions in the form if the caller does not

give you the information that you need. Try and ask them in the order they appear so that

you don’t miss any out.

6.5.5. Action by Recipient of Threat – Mental/physical

This information is applicable to all employees and especially key/card holders and senior

managers.

AbbVie recognises and advises that any employee who may be approached and asked to

facilitate a breach or breaches in security should report this approach and all other

pertinent details to the appropriate person(s), only when it is safe to do so.

Notwithstanding the underlying threat to other persons within AbbVie that a breach in

security may incur, AbbVie recommends that any member of staff who is mentally or

physically placed under duress during an approach for information or a means of access

to the AbbVie facility, should relinquish said items and details without question. This

incident should be reported to the appropriate person(s) as soon as it is safe to do so. Any employee who may be approached should contact the security officer immediately

after the incident and inform the Site Incident Controller on duty as described in the

‘Daily Emergency Organisation Chart.

6.6. RESPONSE PROCEDURE – ANIMAL RIGHTS ACTIVISTS

6.6.1. General Information

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It is a fact, unfortunately, that animal rights activism is becoming more and more of a

problem throughout Europe. Particularly targeted are companies of the chemical and

pharmaceutical industry, which have to conduct animal experiments in order to establish

safety and efficacy of their products. The activities of these activist groups can take place

within the framework of legislations, which means that demonstrations can take place

directly on the spot. However, a distinction needs to be made between such

demonstrations and activities from more extreme groups which operate outside laws and

regulations and who can directly or indirectly harm the company and its employees (e.g.

fire attacks and home visits).

6.6.2. Actions of animal rights activists at the sites can either be known in advance, because

they are often announced on the intranet by the groups, or they can arise unexpectedly.

When appropriate warning systems are put in place, on site security personnel should be

informed in advance. The following recommendations are given:

The main goal is to protect people and premises. "It is a security crisis"

The local crisis management procedures should be applied

If relevant, inform neighbours via mail, personally or eventually through the local press

(if there is some) in advance of a scheduled demonstration

Information can also be given to neighbours right afterwards, to explain what happened

Do not communicate externally more broadly on the principle of animal testing at the

occasion of an animal activists action

No dialogue should be engaged with the activists, especially during the crisis. The risk for

them to hold any declaration against us must be considered

Immediately inform personnel (via Intranet or other channel) about what to do, how to

behave, how to leave the buildings.

If relevant: inform concerned managers (who can be targeted by activists) about the

coverage of their personal property

6.7. ESCAPE OF NATURAL GAS

6.7.1. General

A possible area that could give rise to an escape of gas is the natural gas line, which

supplies the boiler.

6.7.2. Action by Person Detecting the Failure

On discovery of a Gas Leak and / or suppression system leak:

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Contact Maintenance Department and/or EHS&E Department to carry out

investigation.

On confirmation of gas leak activate fire alarm and follow procedures as laid out

in section 6.3.

6.8. MAJOR CHEMICAL SPILLAGE ON-SITE

6.8.1. General

A major chemical spillage is defined in general terms as the spillage of any chemical in

quantities greater than 200 kg and /or in radius greater than 1 meter. The type and nature

of any spillage will determine the seriousness of the potential incident i.e. 20 kg of a very

odorous material may be more difficult to deal with then 2000 kg of a simple alcohol

albeit it is highly flammable.

The Site Incident Controller and/or the ERT Leader may deem the spillage of a smaller

quantity of particular compounds as a major chemical spillage if these compounds have

particularly hazardous properties.

While such spillages may occur anywhere on-site areas of higher risk pertaining to a solid

material spill are Production, and the Warehouse. Liquid chemical spillages would be

higher risk area in the laboratory areas.

The main risk with such spillages is the risk of fire if they are flammable. Other

compounds may be odorous, gaseous, or very volatile and disperse off-site in a plume.

6.8.2. Action by person detecting the failure

On discovery of a Major Chemical Spillage:

1. Alert all occupants in the immediate vicinity to the danger.

2. Go to the nearest Break Glass Unit (BGU) and sound the evacuation siren.

3. Alert your Supervisor and/or Site Incident Controller, if safe to do so.

4. Vacate the area immediately by the nearest Clear Exit. If it is safe to do so,

close all doors behind you in order to prevent the spread of fume and vapours.

5. Report to your Site Incident Controller at your Assembly Point and inform

him/her of the situation at the scene of the incident, outlining how far advanced

the spillage was as you left it.


Controller.

6.8.3. Site Incident Controller


Important:




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1. Carry out all actions as defined in Section 6.3 previously.

2. On becoming aware that the nature of the incident is a major chemical spillage,

ascertain the wind direction and ensure that evacuated staff is safe from any

potential associated plumes and fumes. If necessary, arrange with Site Incident

Controller to move staff to an upwind location or to a safe internal area.

3. Liaises with the ERT Leader on the best method of containing the spillage (if still

continuing) or cleaning it up by using one of the Chemical Spill Kits on-site.

4. Monitor the movement of any plume from the spillage and checks whether it is

moving off-site

5. He must also organise for the Security Guard to call the Emergency Services (Fire

Brigade and Gardai) and inform them that there is an off-site incident developing

following the spillage of a chemical on-site.

6. Liaise with the Emergency Services when they arrive and offer them and any

affected area help and support.

7. Arrange for notification of Cork County Council, Health and Safety Authority and

other applicable regulatory bodies via the EHS&E Manager, where deemed

necessary.

6.8.4. ERT Leader

Note: The actions as described hereunder should be carried out only if it is safe to

do so. Do not take any risks that could threaten your own safety or the safety of

others.


1. Go immediately to the Reception area and establish contact with the Site

Incident Controller via Walkie talkie.

2. Once you have established contact with the Site Incident Controller:

View the Fire Alarm Panel in Reception to get details as to the location of the gas release.

Discuss a plan of action with the Site Incident Controller.

Note: If it is safe to do so for the purposes of additional information, the main panel may

be accessed in the Plant Room.

3. Join the ERT and brief them in regard to the location and nature of the

incident.

4. Try and identify the material spilled by reference to drum or tank labelling,

by taking a sample for analysis if possible and safe to do so etc.

5. Begin directing ERT operations. If you require information/advice in regard

to the following then contact the Site Controller:


Environmental protection measures


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Note: The Emergency Response Team Leader’s role is to direct and co-ordinate the

actions of the Fire Crew only.



Services.

8. Once the Fire Services have arrived on-site, the attendant Fire Officer will assume

control of all fire fighting, as is their right. The AbbVie ERT Leader and Fire

ERT will then act under his instructions.

9. Provide the necessary assistance to the Fire Services while they are on-site.

10. Accept control of the site back from the Emergency Services once they leave the

site.

11. Initiate clean-up activities as directed by the Site Controller.

12. Assist the Site Incident Controller in compilation of an incident report.

6.8.5. ERT

Important:





1. Go immediately to the Reception area to meet with the ERT Leader.


This may involve the use and wearing of specialised Personal Protective Equipment such

as acid suits, safety Wellington boots; hand and eye protection in addition to respiratory

protection. Information and or request for such material should be transmitted via Walkie -

Talkie where possible. In addition, a designated member{s} may be requested to retract

emergency spill kit material located throughout the site. ERT members must be prepared

in the event the spilled material ignites and threatens a major fire on-site.

2 members to bring up one or more of the Chemical Spill kits from the Production Plants

or the Fire Hut. Prepare bags, containers etc. for collection of the spilled material.

3. Follows the ERT Leaders instructions at all times.

4. On the discovery of any casualty, inform the ERT Leader of the need for First

Aid assistance. Where possible remove the casualty to a safe place for treatment.

Remain with the casualty until a First Aider arrives to the Casualty and begins to

treat the casualty.


6. Assist the Fire Services when they arrive on site as directed by the ERT Leader.

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6.9. PANDEMIC PREPAREDNESS

6.9.1. Pandemic Influenza General Information

What is Pandemic Influenza?

Pandemic flu is a contagious human flu that causes a global outbreak, or pandemic, of

serious illness. Because there is little natural immunity, the disease can spread easily from

person to person.

What makes it different from ordinary flu?

Pandemic influenza is different from ‘ordinary’ seasonal flu, which for most people is an

unpleasant illness but runs its natural course (sometimes referred to as ‘self-limiting’) and is

not life-endangering. Pandemic flu can occur when a new influenza virus emerges which is

markedly different from recently circulating strains and to which humans have little or no

immunity. Because of this lack of immunity the virus is able to:

Infect more humans over a large geographical area;

Spread rapidly and efficiently from person to person;

Cause clinical illness in a proportion of those infected.

It is easily passed from person to person when an infected person talks, coughs or sneezes.

It can also spread through hand/face contact after touching anything that may become

contaminated with the virus. Illness develops a few days (average 2-3) after being infected.

Everyone is susceptible, although only about a quarter of the populations are expected to

become ill. Another 25% may catch the infection without getting any symptoms.

What is bird Influenza (avian influenza)?

Bird Influenza —avian influenza—is an infection caused by avian (bird) influenza (flu)

viruses, such as influenza A (H5N1) subtype. Influenza A infection occurs mainly in wild

birds worldwide, which carry the viruses in their intestines, but usually do not get sick

from them. However, avian influenza is very contagious among birds and can make some

domesticated birds, including chickens, ducks, and turkeys, very sick and kill them.

What are the symptoms of avian influenza in humans?

Symptoms of avian influenza in humans have ranged from typical human influenza-like

symptoms (fever, cough, sore throat, and muscle aches) to eye infections, pneumonia,

severe respiratory diseases (such as acute respiratory distress syndrome), and other severe

and life-threatening complications. The symptoms of avian influenza may depend on

which specific virus subtype and strain caused the infection.

What is Swine Influenza (influenza A H1N1v)

Swine flu is a respiratory illness caused by the type A influenza (H1N1) virus.

The influenza pandemic (commonly known as swine flu) in countries around the world

has been caused by a new version (strain) of the virus named as Pandemic (H1N1) 2009

by World Health Organization (WHO).

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Transmission of this virus is thought to occur in the same way as seasonal flu. The

infection can be effectively treated with antiviral medication.

6.9.2. Organisation, Identification And Roles Of Pandemic Influenza Team Members

Pandemic Influenza Coordinator – EHS&E Manager

Devise and implement the EHS Pandemic flu contingency plan

Identify team members and allocate & coordinate tasks

Act as first point of contact in the event of discovery of a suspected case

Devise a questionnaire for personnel exhibiting Pandemic flu symptoms

Coordinate Pandemic flu awareness training for First Aiders

Introduce an awareness campaign site wide

Distribute the Pandemic Preparedness Hygiene kits

Pandemic Influenza Co-ordinator Substitute

Devise and implement the EHS Pandemic Influenza contingency plan

Coordinate the implementation of the AbbVie recommendations into the local plan

Organize the purchase and storage of adequate quantities of PPE approx. 4 weeks supply

Act as substitute in the absence of the Pandemic Influenza coordinator

Assist in all aspects concerning the implementation of the plan

Pandemic Influenza Appointed Medical Practitioner – DR Brian Gallagher EHA

Provide essential medical advice and support concerning the implementation of the plan

Act as appointed medical practitioner for the Fournier EHS Pandemic Influenza

Contingency Plan

First Aiders – list including contact details is included in Attachment 3; Emergency

Response Contact Information

Act as first point of medical contact given the discovery of a suspected human case

Attend Pandemic Influenza awareness training for First Aiders provided by the appointed

avian Influenza trainer

Contact the Pandemic Influenza coordinator or substitute given the discovery of a

suspected case

Pandemic Influenza trainer – Doctor Brian Gallagher

Provide Pandemic Influenza awareness training to all First Aiders on site

Provide ongoing training and information regarding Pandemic Influenza preparedness to

Personnel as required by the Pandemic Influenza coordinator or substitute.

Pandemic Influenza PPE Suppliers

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If required; Provide a backup supply of PPE, in addition to the Pandemic Preparedness

Hygiene kits, as and when required by the Pandemic Influenza coordinator or substitute

Hold a buffer stock of specific items of PPE for all staff

To be capable of providing these supplies within one week of placing the order.

Security

During the course of a defined Pandemic; the classification of which will be determined

by the corporation in line with WHO directives and standards, the security officer will be

informed when and to whom they should supply the Pandemic Influenza Questionnaire

for Personnel Travelling from Abroad to.

Other instructions will be given to the security personnel by the Pandemic co-ordinator,

such as; enforcing hygiene controls to all visitors and contractors which include the hand

disinfectant dispensers located at security and at the entrances to the main production

building and in the porta cabins.

If and when instructed, by the Pandemic co-ordinator, limiting or restricting access to the

site.

Outlining any changes to the site pandemic preparedness policy through verbal

communications to callers to the site, either on the phone or in person.

6.9.3. RISK CATEGORISATION OF PERSONNEL

High Risk

Personnel travelling abroad (if travelling within the attached high risk areas)

Personnel arriving back from abroad (if travelled within the attached high risk areas)

Personnel making deliveries to the plant (if travelled within the attached high risk

areas).

Personnel exhibiting Influenza like symptoms and respiratory problems and having

answered yes to question 1 and / or yes to questions 2 and any of the questions from 3

to 7 in the Pandemic Influenza questionnaire. (Attachment 6 of this procedure)

Medium risk

Personnel travelling abroad (if not travelling within the attached high risk areas)

Personnel arriving back from abroad (if have not travelled within the attached high

risk areas)

Personnel exhibiting Influenza like symptoms and having answered no to all

questions in the proposed Pandemic Influenza questionnaire.

Personnel having respiratory problems and having answered no to all questions in the

proposed Pandemic Influenza questionnaire.

Personnel having direct contact with live poultry or birds

Low risk

Personnel not travelling or having travelled abroad

Personnel not displaying Influenza like symptoms or having respiratory problems

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Personnel answering no to all questions in the proposed Pandemic Influenza

questionnaire

Personnel not in direct contact with live poultry or birds

6.9.4. TRAVELLERS

The Pandemic Influenza questionnaire is located at reception and also at the main

warehouse for personnel arriving from abroad. Advice notes for travellers are attached

and are located in all departments.

6.9.5. HYGIENE

Basic hygiene information signs to be posted in all areas regarding the importance of

washing hands at regular intervals.

An adequate supply of alcohol based hand rub to be purchased and held in stock and to

be distributed to all departments given a confirmed outbreak. All personnel to be asked

to use this product at regular intervals to prevent spread of the disease.

6.9.6. CONTROL MEASURES

The Pandemic Influenza coordinator and substitute to chair meetings with all departments to

provide information and introduce control measures to combat a possible pandemic situation

arising and also to derive information from all departments with a view to identifying high

risk factors and control measures to be introduced.

Training to be provided to all First Aiders and to involve the identification of symptoms and

what to do in the event of a suspected case being identified, this training to be provided by

the appointed avian Influenza trainer.

A questionnaire to be prepared for First Aiders to assist them in identifying possible avian flu

symptoms in a suspected case.

Information to be provided to all departments given the discovery of dead bird or a suspected

case.

Information signage and a questionnaire to be located at reception for personnel having

travelled from abroad and if the risk classification is high then reception will be asked to

contact the avian Influenza coordinator or substitute, who will then ascertain as to whether or

not this person should be allowed entry to the plant or referred to the avian Influenza medical

practitioner.

Information signage and a questionnaire will also be located in the warehouse and personnel

travelling from abroad will be asked to complete the questionnaire, if as above the risk is

classified as high, the warehouse manager / supervisor will contact the avian Influenza

coordinator or substitute who will ascertain as to whether or not this person should be

allowed entry to the plant or referred to the avian Influenza medical practitioner.

A procedure will be devised for the possible discovery of a dead bird / birds, i.e. first point of

contact, call the emergency helpline (1890 252 283) – (Dep’t of agriculture and food) who

will arrange for analysis and disposal of the dead bird / birds i.e. (double plastic bags,

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incineration etc.), health surveillance for all in direct contact with the dead bird / birds,

emergency PPE to be worn, area to be cordoned off.

Information sheets and fact sheets to be distributed to all area managers for distribution to all

personnel intending to travel abroad.

In the event of a confirmed avian Influenza case, restricted areas will be identified and

cordoned off, these areas will be categorized according to the following criteria,

Given the discovery of a confirmed case where the suspected case was located and

areas where the suspected case had travelled to / from.

Given the discovery of confirmed case involving a dead bird / birds, all locations

where the dead birds were found.

Canteen access will be restricted in order to prevent the virus from becoming

pandemic

Information / warning signs to be posted at all access points to the plant and buildings

warning visitors that the avian Influenza virus is present within the plant and information

concerning restricted access to personnel visiting the plant

All suspected human cases of avian Influenza will be referred without delay to the appointed

avian Influenza medical practitioner.

All personnel who have been in direct contact with a suspected case of avian Influenza will

be referred to the appointed avian Influenza medical practitioner for examination.

6.9.7. SANITARY FACILITIES

The basic requirements for sanitary facilities to be checked daily to ensure that a sufficient

supply of sterilizing hand wash is available to last approx 4 weeks.

6.9.8. TRAINING / INFORMATION

List of personnel for Pandemic Influenza awareness training are listed below,

o All First Aiders on site,

o All members of the Pandemic Influenza team.

6.9.9. PERSONAL PROTECTIVE EQUIPMENT INVENTORY

320 disposable masks to the FFFP2 standard to be located on site which will suffice for all

First Aider for 1 week in the event of an outbreak – RISS to hold a buffer stock for all staff

for 4 weeks and be capable of delivery within 1 week.

The type and quantity of disinfectant hand cleanser currently being used on site to be

reviewed to ensure that a grade 1 hand cleanser of sufficient quantity to last 4 weeks is on

hand.

6.9.10. ORGANISATION OF URGENCY OF CARE

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Given an outbreak of an Influenza Pandemic, the company appointed medical practitioner

will be contacted immediately who will in turn contact the CUH to arrange for ambulance

services to be provided.

In the event of a singular case of suspected avian/swine influenza being detected, the

appointed medical practitioner will be contacted immediately who will review the patient and

arrange for ambulance services to be provided.

In the event of a multiple case situation arising the appointed medical practitioner will decide

on the priority of those to be treated initially.

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6.10. ENVIRONMENTAL PROTECTION

In the event of an emergency all materials spilled must be collected, stored and tested

prior to discharge to the environment.

When the emergency is over no water may be discharged from these tanks without its

composition being determined and only on the authorisation of the EHS&E Manager.

It is the responsibility of the Site Incident Controller to arrange for the EHS&E Manager

to contact the Cork County Council and inform the Authorities of the situation pertaining

on-site. It is also EHS&E Managers responsibility to either organise EHS&E and/or

laboratory staff to take samples of firewater, to take air quality samples (where a plume is

involved or there has been an emission to air) etc. If the incident is after-hours EHS&E

Manager should organise for staff to be called in.

Other Agencies to be contacted may include:-

The Industrial Development Authority.

South Western Regional Fisheries Board.

Health & Safety Authority (if applicable).

All information and actions regarding this hazard must also be forwarded to relevant

persons within the Corporation, Head Office.

Environmental incidents that may occur within the site may be tabulated as follows, and

subsequent procures to be followed therein:-

Source Cause Action Responsibility

Chemical Spill / Oil

spill

Spillage due to lack of

containment; impact;

human error; leak from

drum

Isolate the source and

collect the spilled

material. Repair any

leaking equipment /

containers if possible

and is safe to do so.

As per Chemical Spill

procedures

Boiler Equipment not

maintained; faulty part;

failure of equipment

Repair equipment.

Ensure adequate spares

of critical equipment

Maintenance

Fugitive emissions Spill within the process

leading to contamination

of HVAC system of

release to atmosphere

Clean up spill. Repair

equipment. Investigated

source of solvent.

Maintenance in

conjunction with

relevant department

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6.11. RESOURCES

6.11.1. General

Company personnel have been assigned preparatory actions in order to ensure that

appropriate physical resources and facilities are serviceable and readily available should

an emergency occur. It is the responsibility of the EHS&E Department to ensure that the

resources are serviceable and readily available at all times.

6.11.2. Communications

There are 5 Walkie-Talkies in total located in Security. These are kept fully charged at

all times

1. Site Incident Controller

2. ERT Team

3. ERT Leader

4. Security

5. Sprinkler Control/Back up/Emergency Services.

These people are named in Attachment 2 – Key Company Personnel.

6.11.3. Fire Detection, Fire Protection and Fire Fighting Equipment

Fire detection, fire protection and fire fighting equipment are provided on-site and are

checked, inspected and maintained in accordance with recognised standards. This

equipment may be outlined as follows:-

Fire detection and alarm system;

Fire Hydrants

Fire Extinguishers

Spill Response Equipment and Materials

Sprinkler System

Suppression Systems

Two way radios

6.11.4. Evacuation Points

The six Emergency Evacuation Points are located opposite the Security Building in the

car park area and are clearly marked. A printer, which is located in the Reception area,

provides a printout in approximately 2 minutes from alarm activation.

6.11.5. Badge systems and log books – Contractors and visitors

Non-routine Contractors and Visitors evacuate to Assembly Area 6.

An Access Control system is in place for Contractors and Visitors.

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When Contractors and Visitors arrive on site they are required to report to Security where

they are issued with a pass or permit. Each pass has the evacuation procedure listed on

the back of the pass.

Details such as their time on-site and their COMPANY contact is recorded in the Security

Log Book. Their departure from the site is also recorded in this Log Book. This Log

Book (Contractors and Visitors List) is used for the roll call for Contractors and Visitors.

Routine contractors are on the COMPANY Swipe Card system, and their evacuation

point is in the Contractors and Visitors Area.

6.11.6. Emergency services Liaison Information

In order to assist the External Emergency Services when they arrive on site, the site has

prepared information and associated drawings, which are located at the ERT Command

Centre.

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7. REVISION

Revision

No:

Effective Date Reason for Revision

6.0 See Effective

Date

Updated SOP

Updated Section 2 Abbreviations – removed reference to TMS

– Time Management System

Updated Section 6.3.10 Sprinkler System Controller –

clarified that the Sprinkler Controller will be identified as the

situation develops; all of the ERT can perform the duties of

the Sprinkler Controller

Updated Section, 6.4.1 to state that SECURITY will assume

the role of Site Incident Controller outside normal office hours

Updated Section 6.9.1 Pandemic Influenza General

Information – removed information related to specific types of

Avian and Swine influenza

Updated Section 6.11.5 to reflect the procedure for access

control and management of visitors and contractors.

Updated Section 6.11.6 - the location of all emergency

information (drawings etc.) is now the ERT Command Centre.

Updated Attachment 3 Emergency Response Contact

Information to reflect title and personnel changes.

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Firewater Risk Assessment

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Firewater Risk Assessment 2016

04 July 2016

Ref P465380 Prepared for: AbbVie, Carrigtwohill, Co. Cork

Prepared by: AECOM

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60501481 ABBVIE UPDATED FWRA 05-07-2016 ISSUE 2.DOCX

July 2016 Page i

REVISION SCHEDULE

Rev Date Details Prepared by Reviewed by Approved by

1 05 July, 2016 Final Issue Jonathan Ward Danny Ward Danny Ward

REVISION RECORD

Rev Date Details Prepared by Reviewed by Approved by

0 04 July, 2016 Issued to client Jonathan Ward Danny Ward Danny Ward

1 05 July, 2016 Final Issue Jonathan Ward Danny Ward Danny Ward

AECOM Infrastructure & Environment Ireland Limited

4th Floor, Adelphi Plaza, Adelphi Centre,

George’s Street Upper,

Dun Laoghaire,

Co. Dublin,

Ireland.

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July 2016 Page ii

Limitations

AECOM Infrastructure & Environment Ireland Limited (“AECOM”) has prepared this Report for the sole use

of AbbVie, Carrigtwohill, Co. Cork 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 AECOM. This Report is confidential and may not be disclosed by

the Client or relied upon by any other party without the prior and express written agreement of AECOM.

The information contained in this Report is 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 and that such information is accurate. Information obtained by AECOM has not been

independently verified by AECOM, unless otherwise stated in the Report.

The methodology adopted and the sources of information used by AECOM in providing its services are

outlined in this Report. The work described in this Report is based on the conditions encountered and the

information available during the said period of time. The scope of this Report and the services are

accordingly factually limited by these circumstances.

AECOM disclaim any undertaking or obligation to advise any person of any change in any matter affecting

the Report, which may come or be brought to AECOM’s attention after the date of the Report.

Certain statements made in the Report that are not historical facts may constitute estimates, projections or

other forward-looking statements and even though they are based on reasonable assumptions as of the date

of the Report, such forward-looking statements by their nature involve risks and uncertainties that could

cause actual results to differ materially from the results predicted. AECOM specifically does not guarantee

or warrant any estimate or projections contained in this Report.

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 changes.

Copyright

© This Report is the copyright of AECOM Infrastructure & Environment Ireland Limited, a wholly owned

subsidiary of AECOM. Any unauthorised reproduction or usage by any person other than the addressee is

strictly prohibited.

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July 2016 Page iii

TABLE OF CONTENTS 1. INTRODUCTION .......................................................................4

1.1 Requirement for a Firewater Risk Assessment ....................4

1.2 Study Approach .......................................................................4

2. SITE DESCRIPTION IN RELATION TO FIRE RISK ................5

2.1 Current Site Description .........................................................5

2.2 Hardstanding Areas of the Site ..............................................6

2.3 Site Developments ..................................................................6

2.4 Nature of Substances Used on Site.......................................6

2.5 Site Drainage System ..............................................................7

2.5.1 Stormwater Drainage ..............................................................7

2.5.2 Process and Foul Drainage ....................................................7

2.6 Fire Fighting System ...............................................................7

2.7 Emergency Response .............................................................8

2.8 Off-site Fire Safety Services ...................................................8

2.9 Prevention and Control Measures .........................................8

3. RISK ASSESSMENT ................................................................9

3.1 Fire Risk ...................................................................................9

3.2 Environmental Risk .............................................................. 11

3.2.1 Receptors .............................................................................. 11

3.2.2 Carrigtwohill WWTP ............................................................. 11

3.2.3 Soil and Groundwater .......................................................... 11

3.2.4 Surface Water ....................................................................... 11

3.2.5 Substances Released and Containment Provisions ........ 12

3.3 Firewater Runoff Risk .......................................................... 16

3.4 Generation of Firewater and Run-Off ................................. 16

3.4.1 Rain Water ............................................................................. 16

3.4.2 Firewater Generation through Firefighting and Scenario 16

3.4.3 Firewater Generated Based on Scenario ........................... 17

3.5 Requirement for Firewater Retention Facilities ................ 17

3.5.1 Materials with R50 to R53 risk phrases Stored at the Site 17

3.5.2 Sensitive receptors .............................................................. 19

4. CONCLUSION AND RECOMMMENDATIONS ..................... 20

FIGURE 1 – SITE LAYOUT

APPENDIX A – LIST OF MATERIALS USED AT THE SITE

APPENDIX B – FIREWATER RISK ASSESSMENT METHODOLOGY

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1. INTRODUCTION

AECOM Ireland Ltd. (AECOM) was requested by AbbVie, Carrigtwohill, Co. Cork (the site) to prepare an update of their existing firewater risk assessment.

1.1 Requirement for a Firewater Risk Assessment

Condition 3.2 of the site’s current Wastewater Discharge License WP(s) 9/05r requires that a study of a requirement for a firewater retention facility is undertaken. The study should be completed in accordance with the Environmental Protection Agency’s (EPA) “Guidance to Industry on the Establishment of Firewater Retention Facilities” (1995) (The EPA’s Guidance Note).

The original firewater risk assessment study and associated report for the site was prepared by PM in 2004 and updated by URS in 2014. The 2004 and 2014 assessments concluded that firewater retention facilities were not required due to the type and quantity of materials held at the site at that time.

This report takes into account significant changes that took place, or are expected to take place since 2014. The methodology used in this report is based on the EPA’s Guidance Note.

According to the EPA’s Guidance Note, firewater retention facilities are, in general, required if:

• The site stores dangerous substances classified under one of the risk phrases R50 to R53 in

quantities that exceed the listed limits shown in Table 1.1 below; or

• The site discharges surface run-off water into sensitive receiving waters.

Table 1.1: Storage Limits

Risk Phrase Reference Description Volume (Tonnes)

R50 Very toxic to aquatic organisms 1

R51 Toxic to aquatic organisms 10

R52 Harmful to aquatic organisms 100

R53 May cause long-term adverse effects in the aquatic environment

1,000

1.2 Study Approach

To determine the extent, if any, of firewater retention required for current and proposed operations at the site, the following was undertaken:

• The firewater risk assessment from 2004 and 2014 were reviewed;

• The most likely foreseeable fire scenarios were assessed. Based on a site walkover, discussion

with site representative and review of the FM Global Loss Prevention report. These scenarios

are:

� Scenario 1: Fire in the Production Area;

� Scenario 2: Fire in the Warehouse (not yet built);

� Scenario 3: Fire in the Chemstore Building;

� Scenario 4: Fire in the Tank Farm (not yet built); and,

� Scenario 5: Fire in the Waste Store

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• An assessment of the type and quantities of materials used and present at the site as well as

materials which will be used and stored at the site once the proposed new developments

proceed;

• Assessment of environmental setting, including relevant sensitive receptors;

• Identification of known pathways and potential pathways to environmental receptors; and,

• Likely environmental impact consequences, in terms of extent and severity, of the pollutant

and/or firewater quantities and flows.

2. SITE DESCRIPTION IN RELATION TO FIRE RISK

2.1 Current Site Description

AbbVie is a modern “bulk tablet” finish facility, which manufactures solid and capsule formulations using innovative technologies.

Active Pharmaceutical Ingredient (API) particle size reduction is achieved by a nano-milling process resulting in lower dosage formulation. The highly sophisticated technology on site enables delivery of products and processes from small scale clinical trial supply to larger commercial manufacturing.

The facility manufactures a range of products to reduce the cholesterol levels in patients at risk. The processes employed on site include milling, blending, granulation, drying, sieving, tableting, coating and packaging.

Bulk raw materials are stored in a warehouse located of off-site and are brought on site as required; the amount and type of material is described in Appendix A. Minimal quantities of solvents are used on site as cleaning products or in the on-site laboratory. Most of the raw materials used for production are solids (powder or granules). These are mixed with purified water.

The main areas of the site, as shown in Figure 1 (this figures includes the proposed new developments as described below), include:

• Production building with two equipment trains creating 6 products;

• Solvent bulk storage tank farm (not yet built);

• Regenerative Thermal Oxidiser (RTO) (not yet built);

• Ancillary facilities, including a nitrogen skid;

• Up-scale facility (process development);

• Laboratory;

• Product warehouse for storing of raw materials and finished products (not yet built);

• Offices and canteen;

• Waste store building;

• Chemstore building;

• Boiler room;

• pH treatment facility;

• Fire pump house; and,

• Electrical switchrooms;

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2.2 Hardstanding Areas of the Site

The total approximate roof surface area for the buildings present on site is 9,219 m2 which accounts

for the proposed warehouse extension currently under development1.

There are also several other hardstanding areas of the site as follows:

• The employee car parking lots and access roads that is covered with asphalt and is located

along the southern and northern boundary of the site

• An area in the south-western corner of the site in front of the warehouse building

• An area between the western site boundary, the warehouse and the production building

• Walking pathway along the eastern and northern side of the production building

The total area of the hardstanding area described above is 11,843 m2

The total hardstanding area at the site includes buildings roofs and paved ground is approximately 21,062 m

2.

2.3 Site Developments

No significant changes have occurred to the site since 2014 albeit significant developments are proposed. The main changes proposed include:

• The construction of a new warehouse on site to store raw materials on-site;

• The extension of process areas (formerly used for warehousing purposes) to accommodate a

new processes on site;

• The installation of a bulk solvent tank farm and thermal oxidiser;

This update to the firewater risk assessment for the site considers both existing and proposed features of the site as if all were present and operating at the site.

2.4 Nature of Substances Used on Site

Raw materials used in the processes at the site are held in a warehouse in the northern part of the site. In total, there is approximately 53,415

2 tonnes of raw materials being held at the site at any one

time. Other materials held at the site include:

• Chemstore: This building contains coating solution, laboratory waste, oils and lubricants,

reagents and detergents. The quantity of materials that passes through the Chemstore annually

is 25.5 tonnes of coating solution (contains opadry, non-hazardous substance) and 10.5 tonnes

of laboratory chemicals, lubricants, cleaning products. Quantity of flammable materials in

Chemstore at the time of writing this report was approximately 5 tonnes.

• Waste Store: This area usually contains approximately 60 x 200 litre drums of waste granules

(API). It also contains baled contaminated plastic waste. The quantity of materials that passes

through the Waste store annually is approximately 100 tonnes.

• There are two diesel tanks (1,500 litres each) located along the eastern site boundary and

adjacent to the sprinkler pump (see Figure 1).

• Raw materials are present in the main production building in process vessels; up to 9 tonnes at

any one time.

1 Figure described are approximate and account for known proposed expansions plans currently under consideration.

2 Approximate value taken from the current materials list presented in Appendix A.

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Flammable materials stored at the site include:

• Approximately 3,000 litres of diesel stored in two tanks;

• Dodecyl sodium sulphate, raw material, brought to the site as required (maximum two 200 litres

drums a day);

• IPA surface disinfectant (held in the Chemstore), 395 litres;

• Oils, greases and lubricants held in Chemstore, 1,560 litres;

• Solvents in small quantities held in the Chemstore and the laboratory, approximately 2,200

litres;

• Acetone is held in a 32,000 litre bulk tank (future development); and,

• A recovery solvent tank is also present on site and is emptied on a 2 week rotation (future

development).

Explosive materials used or present at the site include:

• Combustible dusts in production areas (formed from raw materials); and,

• Simvastatin which is brought to the site daily, maximum quantity is two 200 litre drums.

A comprehensive list of substances used at the site, together with associated risk and safety phrases is provided in Appendix A of this report.

2.5 Site Drainage System

2.5.1 Stormwater Drainage

Stormwater drainage at the site is collected separately from the process drains and foul drains. The stormwater drainage is a conventional gravity system. The stormwater drainage network serves the parking lot, roofs of the buildings and other outdoor areas of the site. Drainage occurs via a series of gullies & drains that discharge the surface water run-off into a dedicated existing surface water network which then discharges, via petrol interceptors, into the Cork County Council stormwater sewer serving the IDA Business Park. Stormwater drains cannot be isolated, i.e. there is no shut off valves on the stormwater drainage network.

The Cork County Council sewer also serves other facilities in the IDA Business Park within which AbbVie is located. The combined surface water is discharged from the Cork County Council stormwater sewer to the receiving waters in the Great Island Channel.

2.5.2 Process and Foul Drainage

Process effluent from all production areas and the warehouse is routed to the main process effluent sump located on the grass verge in front of the production building’s main door. There is one smaller collection sump that feeds into the main sump located upstream of the main sump. From the main process effluent sump, the process effluent is routed to the pH Correction Plant. From the pH correction plant, process effluent is combined with the foul effluent from the offices adjacent to the production areas and discharged to the Cork County Council foul sewer that runs beneath the road in front of the site.

Foul effluent consists of the canteen and sanitary effluent from the office and canteen building located to the west of the main production building. This effluent is routed along the western boundary of the site into the Cork County Council foul sewer.

2.6 Fire Fighting System

The detection system comprises:

• Fire Alarm System analogue addressable system consisting of:

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� Sounders

� Addressable interface (IO) units (fire dampers)

� Manual call points

� Automatic smoke/heat detectors

• Duct detection installed in all HVAC extract and intake ducting; and,

• Break glass type addressable manual call points;

The current fire suppression system comprises:

• Automatic fire suppression on the tank farms utilizing a 100 litre bladder tank and alcohol

resistant foam (future development).

• Firewater fighting tank 584 m3;

• 2 Firewater pumps (5.68 m3/min);

• Diesel fire pump;

• Electric fire pump;

• Automatic Sprinkler System fed by a 584 m3 firewater fighting tank – covers all areas of the site,

except the Chemstore building;

• 7 fire hydrants (H 1 to H7);

• 150 mm firewater main; and,

• Fire extinguishers throughout all areas of the site.

2.7 Emergency Response

An Emergency Response Plan has been prepared for the site and an Emergency Response Team is also in place at the site. Emergency drills are conducted bi-annually. In case of a fire emergency, the main task of emergency response team is to assist the local fire brigade only.

2.8 Off-site Fire Safety Services

The site is located within the area covered by Midleton Fire Brigade. This fire station is located on Market Green, Midleton, approximately 10 km from the site. In the event of a fire alarm being raised, once the call is received by fire brigade, travel time to AbbVie would be expected to be approximately 10 to 20 minutes depending on traffic. The site’s Emergency Response Plan states that it is responsibility of the “site incident controller” to alert emergency services.

Members of Midleton fire station visited AbbVie to familiarise themselves with the layout of the facility, location of services and to offer general advice to management. The AbbVie site operates 24/7 and there is 24 hours security presence at the site.

2.9 Prevention and Control Measures

AbbVie incorporate a number of measures into daily operations at the facility which reduces the risk of fire at the facility. These are as follows:

• AbbVie have carried out a Hazardous Area Classification Study.

• Hazardous chemicals are present on site and most are stored in a dedicated Chemstore

building, with segregation of materials, concrete floor, underground sump (intended to provide

containment of potential spills in the Chemstore) and automatic fire extinguishers.

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• There is a Spill Prevention Technical Standard in place at the site.

• Electrical Safety Procedure and Hot Work Permits are in place.

• Appropriate training is provided to all employees on spill prevention and management, electrical

safety, fire extinguishers, emergency preparedness.

• Smoking is prohibited on the entire site except for the dedicated smoking area.

3. RISK ASSESSMENT

Four classification criteria are used in this risk assessment. These are:

• Fire Load;

• Fire Risk;

• Environmental Load; and

• Environmental Risk.

Fire Load is considered a function of the quantities of flammable, combustible and oxidising materials being stored in the assessment area.

Fire Risk refers to the likelihood of fire occurring in the assessment area and involves factors such as potential for ignition, ignition sources, fire-fighting equipment, emergency response and fire detection.

3.1 Fire Risk

When undertaking the fire risk assessment the following was identified:

• Potential hazards;

• People who may be at risk; and

• Fire prevention, detection and mitigation measures.

These hazards were then evaluated given a low, medium or high-risk rating based on the likelihood and severity tables detailed in Appendix B.

Table 3.1 below details the findings of the fire risk assessment for each considered scenario. The fire risk assessment is based on:

• Information provided by the site around new developments and operationally changes and the

site visit carried out in 2016;

• Site observations made during site visit by URS in 2014 and information provided by the site

staff; and

• FM Global Loss Prevention Report 2012.

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Table 3.1: Findings of the Fire Risk Assessment

Scenario

No.

Hazard People at Harm Potential consequence Fire Prevention, Detection and

Mitigation Measures

Likelihood Severity Risk Rating

(likelihood of

Severity)

1 Production areas fire: fuel includes general office materials, stainless steel production units and process materials.

• Production personnel

• Fire Brigade personnel

Fire and heat damage to production building, equipment and piping.

• Fire detection system.

• Sprinkler System.

• Smoke detectors in HVAC vents.

• Containment and fire isolation measures.

• Fire retardant materials used throughout the building.

• Explosion vent in the roof.

• Automatic closure of HVAC vents.

Unlikely (2)

Severe (3) Medium (6)

2 Warehouse fire: Materials, packaging and office supplies with the warehouse

• Production personnel

• Fire Brigade personnel

Fire and heat damage to the warehouse building, equipment loss of materials.


• Sprinkler System.

• Smoke detectors in HVAC vents.

• Containment and fire isolation measures.

• Fire retardant materials used throughout the building.

• Explosion vent in the roof.

• Automatic closure of HVAC vents.

Somewhat unlikely (3)


3 Chemstore building fire Fuel: Flammable materials present in Chemstore

Fire Brigade personnel

Fire and heat damage to Chemstore building.

• Materials segregated.

• Smoke detector.

• Automated Fire Extinguishers (each containing 6 kg of ABC Dry Powder).

Unlikely (2)

Significant (2) Low (4)

4 Fire in the Tank Farm Fire Brigade personnel

Fire and heat damage to the tank farm building.


• Deluge System.

Somewhat unlikely (3)


5 Fire in the Wastestore Fire Brigade personnel

Fire and heat damage to Waste store building.

• Smoke detector.

• Manual Fire Extinguisher.

Unlikely (2)

Significant (2) Low (4)

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3.2 Environmental Risk

Environmental Risk refers to the likelihood of there being an adverse effect on the environment during or following a fire event. The likelihood of adverse effect will depend on circumstances such as pathway(s) taken by the released substances, the estimated volume of fire water involved, the provisions for containing released substances and the receptors of the released substances.

The five considered fire scenarios were then evaluated and given a low, medium or high-risk rating based on the likelihood and severity tables referenced in Appendix B. The results of environmental risk assessment are shown in table 3.3 below.

3.2.1 Receptors

Potential receptors of contaminated firewater are:

1. Carrigtwohill Waste Water Treatment Plant (WWTP);

2. Soil and groundwater underneath the site; and

3. Great Island Channel.

3.2.2 Carrigtwohill WWTP

Carrigtwohill WWTP is considered a sensitive receptor in the event of unconfined or uncontrolled loss of contaminated firewater mixtures from AbbVie. The pathways to Carrigtwohill WWTP are process drains. In the event of Scenario 1 and 2, there is a potential that contaminated firewater would enter process drains. If the process drains are not isolated from the Council drains, the contaminated firewater could reach Carrigtwohill WWTP in short time, which is located approximately 1km to the south of the site.

There is no WWTP on site, only a pH balancing tank, which is full most of the time. Also, there are two sumps; however, these are also at least partially full most of the time. Therefore, it would be difficult to contain firewater in process drains at the site.

3.2.3 Soil and Groundwater

There are several areas of the site that are not hardstanding. Therefore, the sensitivity of soil and groundwater as a receptor is considered moderate in the context of a fire scenario on the site. In addition, according the Geological Survey of Ireland on-line maps, the vulnerability of aquifer beneath the site is classified as high.

Groundwater at the site is monitored annually and the most recent monitoring results show no dissolved metals, VOCs, SVOCs or alcohols were detected above detection limits. Also, no TOC, COD or phosphorous readings above relevant environmental guideline values were recorded for groundwater in any of the three wells in 2013. Elevated suspended solids detected in the wells are due to the turbid groundwater encountered during sampling, related to the silty aquifer material. Suspended solids have no direct health of sanitary significance.

3.2.4 Surface Water

Surface water bodies are considered the sensitive receptor in the event of unconfined or uncontrolled loss of contaminated firewater mixtures from AbbVie.

The surface water sewer system discharges ultimately to Slatty Bridge, at a point located approximately 0.8 km south of the site. This is part of Great Island Channel; a Special Area of Conservation and a Proposed National Heritage Area.

Great Island Channel is extremely important for wintering waterfowl. The site is an integral part of Cork Harbour which is a wetland of international importance for the birds it supports. It also supports a good invertebrate fauna. While the main land use within the site is aquaculture (Oyster farming), the greatest threats to its conservation significance come from road works, infilling, sewage outflows and possible marina developments

3.

3 Information taken from the National Parks and Wildlife Service Site Synopsis.

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According to the EPA document ‘Water Quality in Ireland 2007 – 2009, the receiving waters for AbbVie’s stormwater are classified as:

• North Channel Great Island – potentially eutrophic

• Cork Harbour – intermediate water quality.

The pathway to surface waters is the stormwater drainage system. The stormwater drainage system has been described in Section 2.6. This system would be the principal means of conveyance of polluting matter to the Great Island Channel. In the event of firewater entering the site’s stormwater drainage system, such firewater will reach the Great Island Channel in a short period of time. There is no diversion system, containment system or isolation system in place to mitigate against this occurrence.

3.2.5 Substances Released and Containment Provisions

In the event of a fire at AbbVie in one of the key risk areas, the substance released will be contaminated firewater runoff that may or may not include rain water. The pollution potential of the firewater runoff will be largely due to the chemical content and BOD, caused by:

• Substances at the location of fire; and

• Firefighting media.

In order to approximately estimate potential toxicity of firewater, the United States Fish and Wildlife Service (FWS) scale is used, which is provided in Table 3.2 below.

Table 3.2: Potential Toxicity of Firewater

Relative Toxicity Aquatic EC50 (mg/L) or LC50(mg/L

Super Toxic <0.01

Extremely Toxic 0.01-0.1

Highly Toxic 0.01-0.1

Moderately 1 - 10

Slightly Toxic 10-100

Practically Nontoxic 100 – 1,000

Relatively Harmless >1,000

There are several raw materials at the site that have slight toxicity (Sodium Dodecyl Sulphate Docusate Sodium, Methacrylic Acid, Fenofibrate tablets – for detail see Appendix A.) Sodium Lauryl Sulphate is moderately toxic and fenofibrate in pure form is highly toxic. However, it should be noted that the amounts of these substances at the site are relatively low (see Table 3.8 and 3.9 below), and it is likely that large proportion of these substances would burn off. Typical firefighting foams would be considered slightly toxic to practically non-toxic

4.

There are no dedicated containment areas at AbbVie for firewater at present except:

1. Final process effluent sumps x 2;

2. Trilipix effluent UST (20 m3);

4 UK Fire Industry Association “Aquatic Toxicity of Fire Fighting Foams”

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3. Trilipix AST (7 m3);

4. Waste store and Chemstore sumps (2 x 1.1 m3).

Containment areas 1-4 could only be used in Scenario 1, and containment area 4 could be used in Scenarios 3 (Chemstore building fire) and 2 (Warehouse building fire).

Table 3.3 below details the findings of the environmental risk assessment carried out for each of the 5 scenarios considered. The environmental risk assessment is based on the following:

• Information provided by the site around new developments and operationally changes and the

site visit carried out in 2016;

• Site observations made during site visit by URS in 2014; and

• FM Global Loss Prevention Report 2012.

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Table 3.3: Findings of the Environmental Risk Assessment

Scenario No.

Hazzard Consequence Prevention & Mitigation measures

Contamination Source Transport Potential Damage Potential

Likelihood Severity Risk Rating

1 Production areas fire

• Accumulation of firewater in the production building

• Fire water escapes from the production facility and soaks into the ground around the facility and stormwater drainage systems.

Trilipix area effluent can be collected in a UST and an AST, 2 sumps and drainage system.

Office materials present will likely burn off before exiting the building. In case of fire spreading, it is still unlikely that raw materials would contaminate fire water, as these are in steel process vessels or closed steel IBCs and there is a minimum quantity held within the production area.

• If the firewater exits the Production Building, it could be transported into groundwater through the flow of water from the automatically opened emergency doors.

• Firewater may also enter the process drains within the production area. In this instance the material would be transported to the process and foul drain system.

• The potential for firewater reaching storm sewer is high, as the fire doors would be open at the time of a fire incident.

Contamination of groundwater and surface water with firewater with low levels of contamination, but it is unlikely that any materials with risk phrases R50-R53 would be contained in the firewater due to the low amount kept on site.

Low (2) Moderate (3)

Medium (6)

2 Warehouse building fire

• Accumulation of firewater in Warehouse;

• Firewater is released from the building through the goods-in door and open fire exits.

None Firewater could potentially get contaminated with raw material, including materials with R values R52. Other general warehouse supplies including cardboard, woods and packaging is unlikely to be mobilised during a fire.

• There is potential for groundwater contamination due to unmade ground areas outside the warehouse.

• The potential for firewater reaching storm sewer is high, due to the location of the nearest storm drain and the lack of opportunities for control.

Contamination of groundwater and surface water from firewater with low levels of contamination, potentially containing low levels of materials with R52 risk phrase.

Low (2) Moderate (3)

Medium (6)

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3 Chemstore building fire

• Accumulation of firewater in Chemstore.

• Firewater is released from the building and soaks into unmade ground in behind the Chemstore building or into the site stormwater system.

There is a 1,100 litre underground sump connected to the Chemstore.

Firewater is likely to get contaminated with solvents, lubricants and greases, and other materials in Chemstore, none of which have risk phrases R50-R53.

• There is some potential for groundwater contamination due to unmade ground areas near the chemstore.

• The potential for firewater reaching storm sewer is high, due to the location of the nearest storm drain.

Contamination of groundwater and surface water with firewater containing low levels of contamination. However, there will no materials with risk phrases R50-52 contained in the firewater runoff.

Low (2) Minor (2) Low (4)

4 Fire in the tank farm

Release of fire water associated with the deluge of the solvent tank farm

Bund storage with capacity of 110% of the tank volume.

Firewater is likely to get contaminated with solvents, and other materials in the tank farm.

• There is potential for groundwater contamination due to unmade ground areas near the fire tank farm.

• The potential for firewater reaching storm sewer is low, due to the location of the nearest storm drain.

Contamination of groundwater and surface water with firewater with low levels of contamination, but no materials with risk phrases R50-53, Acetone, the main product held at the tank farm will evaporate over time or be burnt off quickly during the fire.

Low (2) Minor (2) Low (4)

5 Fire in the Wastestore

• Accumulation of firewater in Waste store;

• Firewater is released from the building and soaks into unmade ground in behind Waste Store

There is a 1,100 litre underground tank that serves as a sump connected to the Waste store.

Firewater could potentially get contaminated with waste API (fenofibreate R52) that may be stored in the Waste store.

• There is some potential for groundwater contamination due to unmade ground areas near waste store building.

• The potential for firewater reaching storm sewer is low, due to the location of the nearest storm drain.

Contamination of groundwater and surface water with firewater with low levels of contamination, potentially containing low levels of materials with R52.

Low (2) Moderate(3)

Medium (6)

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3.3 Firewater Runoff Risk

Table 3.4 below summarises the findings of the firewater risk assessment carried out on each of the scenario areas considered by this report. Overall firewater risk is considered medium-to-low for all five scenarios considered.

Table 3.4: Firewater Risk Assessment

Scenario No. Hazzard Risk Rating

Fire Risk (From Table 3.1)

Environmental Risk (From Table 3.3)

Overall Risk

1 Production Area Fire

Medium Medium Medium

2 Warehouse Fire Medium Medium Medium

3 Chemstore Fire Low Low Low

4 Tank farm Fire Medium Low Low

5 Wastestore Fire Low Medium Low

3.4 Generation of Firewater and Run-Off

3.4.1 Rain Water

In accordance with EPA guidance5 the rainfall value used in the assessment was the maximum 24

hour rainfall event between 1961 and 1991, for cork airport was 86.7 mm. The value for rainfall over 90 minutes was then calculated (90 minutes represents a worst case scenario of a fire burning). This value was the multiplied by the hard standing area of the site (21,062m

2 – see section 2.2) to give

rainfall over the entire area of 115 m3 with the potential to be contaminated.

3.4.2 Firewater Generation through Firefighting and Scenario

The fire water application rate, and subsequent volume of water generated is based on the information provided in Table 3.5.

Table 3.5: Fire Fighting

Fire Fighting Unit Discharge/Rate

Sprinkler System6 9.62 m

3/min. Depositing 865.98 m

3 in 90 min

7.

Rain water 115 m3 in 90 min over the entire area

Fire Tenders (assumed that tenders connects to fire hydrant at site and pumps at maximum capacity for

duration of fire)

320 m3 in 80 min (2000 litres per minute per tender x

2 tenders = 4000 litres per minute)8

Tank farm water bladder 100 litres (0.1 m3 )

5 Environment Agency, Pollution prevention Guidelines: PPG 18. EPA, Guidance Note to Industry on the Requirements for Fire-Water

Retention Facilities. 6 The sprinkler system in the Production Area and Warehouse are considered to have the same approximate rate and subsequently

generate the same volume of firewater. 7 A worst case scenario is assumed whereby the sprinklers operate at full capacity for 90 minutes is assumed. This is based on the

recharge capabilities of the firewater holding tank (584 m3) in 18 minutes resulting in no reduction in flow.

8 Values based on AECOM experience with similar sites. 80 minutes reflects a 90 minute fire minus 10 minutes of mobilisation.

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3.4.3 Firewater Generated Based on Scenario

Each fire scenario has the potential to generate different volumes of firewater. Table 3.6 quantifies the volume of material for each scenario.

Table 3.6 Firewater Generated by Scenario

Scenario Volume of Firewater Generated Comment

1. Production Area Fire

1,300.98 m3 Sources of firewater in the production area are:

• Sprinkler system 865.98 m3

• Rainfall 115 m3

• Fire tender water 320 m3

2. Warehouse Fire 1,300.98 m3 Sources of firewater in the warehouse area are:

• Sprinkler system 865.98 m3

• Rainfall115 m3


3. Chemstore Fire 410 m3 Sources of firewater in the chemstore area are:

• Rainfall 115 m3


4. Tank Farm Fire 467.1 m3

(500.1 m3 - 33 m

3)

The bund storage (110%) of the volume of the tank has the capacity to contain 33 m

3 of fire water.

Sources of firewater in the tank farm are:

• Tank content 30 m3

• Waste solvent tank 35 m3

• Rainfall 115 m3


• Deluge system 0.1 m3 with alcohol

resistant foam suppression system; typical alcohol resistant foams do are bio-degradable and are of low toxicity to aquatic organisms.

5. Waste Store Fire 433.9 m3

(435 m3 – 1.1 m

3)

Sources of firewater in the waste store area are:

• Rainfall 115 m3


There is a 1,100 litre (1.1 m3) underground tank

that serves as a sump connected to the Waste store.

3.5 Requirement for Firewater Retention Facilities

3.5.1 Materials with R50 to R53 risk phrases Stored at the Site

In the EPA’s Guidance Note, materials with risk phrases R50 to R53 are listed as having storage limit requirements, above which fire water retention facilities are required, as shown in table 3.7. Corresponding Hazzard Statements are also shown.

Table 3.7: Storage limits

Risk

Phrase

reference

Risk Phrase Reference Risk

Volume

Hazzard

Statement

Reference

R50 Very toxic to aquatic organisms

1 H373 May cause damage to organs through prolonged or repeated exposure

R51 Toxic to aquatic organisms 10 H400 Very toxic to aquatic life

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R52 Harmful to aquatic organisms

100 H401 Toxic to aquatic life

R53 May cause long-term adverse effects in the aquatic environment

1,000

H402 Harmful to aquatic life

H410 Very toxic to aquatic life with long-lasting effects

H411 Toxic to aquatic life with long-lasting effects

H412 Harmful to aquatic life with long-lasting effects

H413 May cause long-lasting harmful effects to aquatic life

Table 3.8 below presents estimated quantities of materials with risk phrases R50 to R53 at the site and their locations.

Table 3.8: The Materials Used at the Site With R50 to R53 Phrases

Substance Site Location Risk

Phrase

Reference

Risk phrase Maximum Quantity

Stored At Specific

Location(Tonnes)

Tricor Fenofibrate 145mg US

Production Building / Warehouse

R53 H413 23.63 Tonnes

Tricor Fenofibrate 48mg EU


R53 H413 0.005 Tonnes

USP/EP Sodium Lauryl Sulphate


R53 H412 1.9 Tonnes

Trilipix FR 135mg Production Building / Warehouse

R53 H413 0.56 Tonnes

Choline Fenofibrate Warehouse R52 / R53 H413 3.7 Tonnes

Fenofibrate Warehouse R53 H413 1.6 Tonnes

USP/EP Docusate Sodium Warehouse R52 H402 0.2 Tonnes

USP/EP Micronised Fenofibrate (ES)

Warehouse R53 H413 0.2 Tonnes

USP/EP Micronised Fenofibrate (FR)


Fenofibrate USP/EP NonMicronised FR


Ombitasvir GN (EXT) V1 Verkauf


Talc U ABT-333 API (A.998821.5)SP, Non-asbestos containing.


HCV Quad Warehouse N/A H413 3.15 Tonnes (used annually)

ABT450 Extrudate DE Warehouse R22 H413 0.04 Tonnes (used annually)

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ABT267 Extrudate DE Warehouse R22 H413 0.2 Tonnes

API waste Waste store R52 H413 There is a potential for 60 x 200 litre

drums of waste API extrudate to be held in here. In the worst case, if this is 100% API, it would amount

to 12 tonnes of fenofibrate.

All listed quantities are at least a magnitude of value lower than storage thresholds listed in Table 3.9.

Table 3.9: Storage Limits

Risk Phrase

reference

Risk Phrase Reference Storage Threshold (as per

EPA guidance)

Volume Stored

on Site9

R50 Very toxic to aquatic organisms 1 0

R51 Toxic to aquatic organisms 10 0

R52 Harmful to aquatic organisms 100

< 43 R53 May cause long-term adverse

effects in the aquatic environment 1,000

3.5.2 Sensitive receptors

Sensitive receptors for firewater at AbbVie are Carrigtwohill WWTP, groundwater underneath the site and Surfacewater Receptors (i.e. the Great Island Channel).

Firewater reaching Carrigtwohill WWTP would most likely arise in Scenario 1and 2, such firewater would potentially be contaminated with raw ingredients from the process. The only raw material with low degradability is eudragit used for Trilipix tablet coating. The only raw material with R50 – R53 risk phrase is Tricor Fenofibrate 145 mg US, Tricor Fenofibrate 48 mg EU and USP/EP Sodium Lauryl Sulphate. Given that process effluent at AbbVie only receives pH balancing treatment before being discharged into council sewer, trace amounts of fenofibrate are being released into the sewer on continuous basis with no adverse effects on the WWTP. Also, AbbVie effluent has been tested for sludge inhibition, and the results were negative. Therefore, it is unlikely that firewater from Scenario 1 would have long term negative impacts on the Carrigtwohill WWTP.

In all five likely fire scenarios there is a potential that contaminated firewater reaches groundwater underneath the site. It can be assumed that most of the flammable and combustible materials would be burned off before contaminating firewater and reaching groundwater. Furthermore, most of the substances present in the Chemstore, will dissociate/biodegrade rapidly in groundwater, thus any resulting damage to groundwater would be short term and reversible.

In all five likely fire scenarios there is a potential that contaminated firewater discharges to stormwater drains and ultimately discharges to surface water; however, a lot of contaminants would be burned off, and some firewater would soak into the unmade ground areas before reaching the stormwater drains. Therefore, only a portion of firewater would reach stormwater drains and Great Island Channel. In the case of a fire in the production area and warehouse there is a potential that

9 The volume presented is based on materials stored on site. From time to time there are minimal quantities of R50, R51 and R52

materials present which are not included in this calculation. This volume would be less than 30 litres (0.03 m3) associated primarily with

laboratory processes and do not alter the storage limits).

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materials with risk phrases R52 or R53 (waste APIs) would be present in the firewater, however it is noted that the environmental risk rating associated with a fire in this area is not considered high.

4. CONCLUSION AND RECOMMMENDATIONS

The assessment presented in this report demonstrated that risk of adverse impact on the environment caused by firewater is low to medium for the AbbVie site primarily due to the nature and quantity of materials stored at the site:

• The amount of flammable materials stored at site is approximately 39,755 litres comprising

diesel (stored in aboveground storage tanks), oils and greases in Chemstore, solvents in tank

farm and laboratory, and cleaning materials in Chemstore.

• The maximum amount of materials with risk phrases R52 and R53 stored at the site is

approximately 43 tonnes.

• The production building, utilities, product warehouse, laboratory and scale-up facility are

covered by fire alarm and an automatic sprinkler system;

• Chemstore has automatic fire extinguishers and a smoke detector;

• Flammable materials are stored following best practice.

The worst case scenario envisaged would be a fire in the Wastestore (not protected by sprinkler system or automatic fire extinguishers), which would result in firewater potentially contaminated with R52 or R53 reaching the Great Island Channel. Importantly, the likelihood of such fire is low, and the approximate maximum amount of R52 material potentially present is approximately 12 tonnes (nearly 10 times less than the threshold in the EPA Guidance Note).

In conclusion, based on the above assessment and the EPA’s Guidance Note, firewater retention facilities for the AbbVie site at Carrigtwohill, Co Cork are not required.

In order to further reduce environmental risks posed by firewater at the site, AECOM recommends that the following is implemented at the site as a best practice:

• Installation of a manual or an automatic shut off valve at the place where the stormwater drain

exits the site, in order to contain potential firewater or any other potentially contaminated

stormwater leaving the site and entering surface water.

• The site should investigate the feasibility of installing automatic fire extinguishers in the

Wastestore similar to what is installed on the chemstore.

• The site should consider paving the unpaved gravel area immediately around and between the

Wastestore and Chemstore buildings. This would prevent firewater contaminating soil and

groundwater underneath the site. It would also provide protection to soil and groundwater

against spills of hazardous materials.

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FIGURE 1 – SITE LAYOUT

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CREON DR

EXISTING FACILITY

CANTEENOFFICES

SERVICE AREA

ERT

SECURITY

SHORT TERM

CAR PARK

CAR PARK

ESB

WATER

TANKAHV

PLINTH

GAS

PUMP

HS.

BIO

MASS

CAR PARK

PROPOSED

EXTENSION

PROPOSED PIPE RACK

PROPOSED

SOLUTION &

WASTE TANKS

WAREHOUSE

(BY OTHERS)

THERMAL

OXIDISER

LIQUID

NITROGEN

SKID

TRANSIT

AREA

1. THIS DRAWING SHALL BE READ IN CONJUNCTION WITH THE DPSSTEELWORK SPECIFICATION AND SCOPE OF WORKS.

2. FIGURED DIMENSIONS ONLY TO BE TAKEN FROM THIS DRAWING. ALL

DIMENSIONS TO BE CHECKED ON SITE. ENGINEER TO BE INFORMEDIMMEDIATELY OF ANY DISCREPANCIES BEFORE WORK PROCEEDS.

3. ALL LEVELS ARE IN METRES, ALL DIMENSIONS ARE IN MILLIMETRES.

4. ANY DISCREPANCIES TO BE REPORTED TO THE ENGINEER

IMMEDIATELY.5. ALL SETTING OUT INDICATED THUS * IS INDICATIVE ONLY AND

SHOULD BE VERIFIED ON SITE BY THE CONTRACTOR IN CONJUNCTION

WITH THE CONSTRUCTION MANAGEMENT TEAM.

LEGEND

EXISTING BUILDINGS

PROPOSED EXTENSION

PROPOSED PIPE RACK

PROPOSED SOLUTION & WASTE TANKS

PROPOSED LIQUID NITROGEN SKID

WAREHOUSE BY OTHERS

THERMAL OXIDISER

EXISTING CREON DR

EXISTING TRANSIT AREA

THIS DRAWING IS THE PROPERTY OF DPS AND SHALL NOT BE USED, REPRODUCED ORDISCLOSED TO ANYONE WITHOUT THE PRIOR WRITTEN PERMISSION OF DPS AND SHALL BE

RETURNED UPON REQUEST.

PROJECT

TITLE

CLIENT

STATUS

REV DATE DESCRIPTION CHKD.DES.DRN. APPR.

PROJECT No. A1 SCALE

CLIENT DRAWING NO. REVDRAWING NO.

DISCIPLINE

SHT

NOTES

P:\2015\115222\Drawings\3D BIM\Revit\Model\CSA\115222-AbbVie.rvt

CREON DR

PROPOSED SITE LAYOUT

115222-AE-002 A

115222

CONCEPT

ARCHITECTURAL

A 01.03.2016 ISSUED FOR CONCEPT

1:500

SCALE: 1 : 500

PROPOSED SITE LAYOUT

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APPENDIX A – LIST OF MATERIALS USED AT THE SITE

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Ref.No or

Code

Material/Substance Amount Stored (Tonnes) Annual Usage (Tonnes) Nature of Use Hazard Statement

H373 - May cause damage to organs through prolonged or repeated

exposure

H413 - May cause long-lasting harmful effects to aquatic life

H373


H228

H302

H332

H315

H318

H335

H412 - Harmful to aquatic life with long-lasting effects

H302

H318

H373

H413 May cause long-lasting harmful effects to aquatic life

H302

H318

H373


H302

H318

H373


H373


H315

H318

H402 ‑ Harmful to aquatic life

H373


H373


H373


44 Ombitasvir GN (EXT) V1 Verkauf 0.8 Raw Material API H413 - May cause long-lasting harmful effects to aquatic life

45 Talc U ABT-333 API (A.998821.5)SP, Nonasbestos

containing

1.7 1.8 Raw Material API H413 - May cause long-lasting harmful effects to aquatic life

H302

H319

H351

H361


H302


70 ABT267 Extrudate DE 0.2 Raw Material API H413 - May cause long-lasting harmful effects to aquatic life

1

(this is litres)

H290 87 Diphenylamine Solution 3 (this is litres) Lab Analytical Method

85 Potassium Permanganate Lab Analytical Method H410 - Very toxic to aquatic life with long-lasting effects

69 ABT450 Extrudate DE 0.04 Raw Material API

68 HCV Quad 3.15 Drug Product

29 Fenofibrate USP/EP NonMicronised FR 0.4 Raw Material API

25 USP/EP Micronised Fenofibrate (FR) 19.9 79 Raw Material API

24 USP/EP Micronised Fenofibrate (ES) 0.2 Raw Material API

20 USP/EP Docusate Sodium 0.2 1.7 Raw material

16 Fenofibrate 1.6 79 Raw Material API

14 Choline Fenofibrate 3.7 15.6 Raw Material API

13 Trilipix FR 135mg 0.56 23.69 Finished Product

11 Trilipix Choline Fenofibrate 45g US 0.68 2.77 Finished Product

8 USP/EP Sodium Lauryl Sulphate 1.9 4.8 Raw Material

2 Tricor Fenofibrate 48mg EU 0.005 6.39 Finished Product

1 Tricor Fenofibrate 145mg US 23.63 341.21 Finished Product

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H314

H318

H330

H350

H370

H372

H400 - Very toxic to aquatic life

H402 ‑ Harmful to aquatic life

H302

H319

H335

H410 - Very toxic to aquatic life with long-lasting effects

H351

H360Df

H373


H228

H302

H332

H315

H318

H335


H302

H315

H318

H332

H351

H372

H401 - Toxic to aquatic life

H272

H302

H332

H318

H360Df

H373


H290

H302 + H312,

H315

H317

H319

H351

H373


H290

H300 + H310 + H330,

H370

H372


H302

H350

107 Hydrazinium Sulphate Lab Smalls, low quantity Lab Analytical Method

104 Potassium cyanide 0.000026 Lab Analytical Method

100 Hydroxylamine Hydrochloride 0.001 Lab Analytical Method

99 Lead Nitrate 12.9 (this is litres) Lab Analytical Method

98 Potassium Pyroantimonate Lab Smalls, low quantity Lab Analytical Method

96 Sodium Laurel Sulphate Lab Smalls, low quantity Lab Analytical Method

94 Lead Acetate 0.0005 Lab Analytical Method

88 Chlorine Tablets Lab Smalls, low quantity Lab Analytical Method

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H225

H319

H336

H302

H315

H319

H350


H302

H314

H335


H302

H314

H411 - Toxic to aquatic life with long-lasting effects

H300

H314

H341

H361f

H372


H330

H373


H300 + H310 + H330

H373


H272

H302

H317

H334

H341

H350i

H360F


H350i

H360F


H225

H304

H315

H336

H361f

H373


H319

H335


H302+H312+H332


155 Ammonium Thiocyanate Lab Smalls, low quantity Lab Analytical Method

147 Acetaminophen Lab Smalls, low quantity Lab Analytical Method

143 Hexane 2.5(this is litres) Lab Analytical Method

142 Slica Gel Self Indicating Lab Smalls, low quantity Lab Analytical Method

141 Cobalt (II) Nitrate 0.001 Lab Analytical Method

136 Mercury (II) Iodide Red 0.0001 Lab Analytical Method

135 Mercury (II) Iodide 0.00025 Lab Analytical Method

134 Mercury (II) Chloride 0.00005 Lab Analytical Method

127 Thymol 0.0001 Lab Analytical Method

123 Ammonium hydroxide 8(this is litres) Lab Analytical Method

110 Thioacetamide Lab Smalls, low quantity Lab Analytical Method

109 Acetone 18 (this is litres) Lab Analytical Method

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H301

H314


H302

H315

H319


H302


H311

H314

H351




H302

H350


H302

H319


H373


H301+H311+H331,

H373


201 Methyl Red 0.00025 Lab Analytical Method H411 - Toxic to aquatic life with long-lasting effects

H225

H304

H315

H336


208 n-Pentane 26(this is litres) Lab Analytical Method

H225

H304

H336


222 Potassium hexacyanoferrate trihydrate 0.00025 Lab Analytical Method H412 - Harmful to aquatic life with long-lasting effects

H272

H302

H314


H301

H331


H302

H314


H315

H319


256 Zinc Chloride 0.1N Lab Smalls, low quantity Lab Analytical Method

255 Zinc Chloride 0.004 (this is litres) Lab Analytical Method

251 Thorin Lab Smalls, low quantity Lab Analytical Method

232 Silver nitrate 0.1 M 0.00005 Lab Analytical Method

211 Pentane Lab Smalls, low quantity Lab Analytical Method

206 n-Heptane 39(this is litres) Lab Analytical Method

195 Melting Point Standard 4-nitrotoluene Lab Smalls, low quantity Lab Analytical Method

192 Manganese (II) Sulfate Hydrated 0.001 Lab Analytical Method

188 Igepal 0.1(this is litres) Lab Analytical Method

186 Hydrazinium Sulphate Lab Smalls, low quantity Lab Analytical Method

177 Fehling's reagent, solution A 13(this is litres) Lab Analytical Method

170 Dichloroacetic Acid 0.0205(this is litres) Lab Analytical Method

168 Copper Oxide Wire Lab Smalls, low quantity Lab Analytical Method

167 Copper (II) Sulfate 0.001 Lab Analytical Method

160 Benzethonium Chloride 0.00375 Lab Analytical Method

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H319


H319


H314

H332


H302

H314

H317



272 Klercide x 350 (this is litres) Disinfectant

265 Trifluoroacetic Acid 0.08 Lab Analytical Method

258 Zinc Sulphate 0.1M 0.25 (this is litres) Lab Analytical Method

257 Zinc Sulphate 0.05M Lab Smalls, low quantity Lab Analytical Method

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APPENDIX B – FIREWATER RISK ASSESSMENT METHODOLOGY

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Firewater Risk Assessment Methodology

Identification of Potential Hazards

For a fire to start, three things are needed: a source of ignition, fuel and oxygen.

Should any of these three elements be missing a fire cannot start.

Some typical sources of ignition that may occur in the assessment area around

the site include:

• Naked flames, i.e. gas or liquid-fuelled open-flame equipment;

• Hot processes/hot work, e.g. welding by contractors or shrink wrapping;

• Heat sources, such as gas, electric, microwaves, radio frequency,

thermal fluids;

• Frictional generated heat from mechanical equipment;

• Static charge from mechanical equipment i.e. pumps;

• Poor electrical installations, i.e. overloads, heating from bunched cables,

damaged cable;

• Faulty or misused electrical equipment;

• Light fittings and lighting equipment, e.g. halogen lamps or display

lighting or overhead lights too close to stored products;

• Hot surfaces and obstruction of equipment ventilation; and

• Spontaneous ignition and self-heating, e.g. oil soaked rags, paint

scrapings.

The main source of oxygen for a fire is in the air around us. Additional sources of

oxygen that may be introduced to the assessment area include:

• Some chemicals (oxidizing materials), which can provide a fire with

additional oxygen and so help it burn.

• Oxygen supplies from cylinder storage and piped systems, e.g. oxygen

used in welding processes.

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Identification of People who may be at Risk

The risk assessment considers people who may be at harm including the

following:

• People who are in isolated areas, e.g. maintenance staff, truck drivers;

• People who are unfamiliar with the premises, e.g. contractors, visitors

and customers;

• People in the immediate vicinity of the premises; and

• Emergency response personnel.

Fire Prevention, Detection and Mitigation Measures

As part of a fire risk assessment the following control measures should be taken

into account:

• Fire prevention measures in place.

• Fire protection measures in place.

• Fire fighting equipment and facilities.

• Fire containment measures.

• Emergency preparedness and response.

• Escape routes.

• Signs and notices.

• Recording, planning, informing, instruction and training systems in place

at the facility.

Evaluating the Fire Risk

The risk of a fire occurring is the product of the likelihood of a fire occurring by

the consequence of such a fire.

Risk = Likelihood x Consequence

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Table C1: Likelihood of a fire occurring

Category Definition

1 Very unlikely No fuel source is present at any time or

No ignition source is present at any time.

2 Unlikely No fuel source is present during normal operation or

No ignition source is present during normal operation.

3 Somewhat

unlikely

Fuel source is present at any time.

Low potential for ignition source to be present at any time.

Or

Low potential for fuel source to be present at any time.

Ignition source is present at any time.

4 Probable Fuel source is present at any time.

Moderate potential for ignition source to be present at any time.

Or

Moderate potential for fuel source to be present at any time.


5 Very

probable

Fuel source is present at any time or


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Table C2: Consequence of a fire occurring

Category Definition

1 Minor • No risk of injury

• Good fire protection measures in place

• Good fire fighting equipment and facilities in place

• Minor quantities of flammable material in the assessment

area

• Good fire containment measures

• Good emergency preparedness and response

2 Significant • Risk of minor injury

• Adequate fire protection measures in place

• Adequate fire fighting equipment and facilities in place

• Limited quantity of flammable material in the assessment area

• Adequate fire containment measures

• Adequate emergency preparedness and response

3 Severe • Risk of serious injury

• Some fire protection measures in place

• Some fire fighting equipment and facilities in place

• Quantity of flammable material in the assessment area is

equal to the lower tier SEVESO threshold limits.

• Some fire containment measures

• Some emergency preparedness and response

4 Major • Risk of multiple serious injuries or fatality

• Inadequate fire protection measures in place

• Inadequate fire fighting equipment and facilities in place

• Quantity of flammable materials in the assessment area is

above the lower tier SEVESO threshold limits.

• Inadequate fire containment measures

• Inadequate emergency preparedness and response

5 Catastrophic • Risk of multiple fatalities

• Inadequate fire protection measures in place

• Inadequate fire fighting equipment and facilities in place

• Quantities of flammable material in the assessment area are

above the upper tier SEVESO threshold limits.

• Inadequate fire containment measures

• Inadequate emergency preparedness and response

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Table C3: Fire Risk Assessment Matrix

Severity of Consequence L

ikelih

oo

d o

f o

ccu

rren

ce Minor Significant Severe Major Catastrophic

Very unlikely 1 2 3 4 5

Unlikely 2 4 6 8 10

Somewhat

unlikely 3 6 9 12 15

Probable 4 8 12 16 20

Very probable 5 10 15 20 25

Note:

1. Low (4 or less)

2. Medium (5 to 10)

3. High (12 or more)

Environmental Risk Assessment Methodology

In assessing the hazard rating to the aquatic environment the assessment

considered:

• Source: It is important to be clear that in the context of assessing

hazard, source refers solely to the hazardous materials

present on the site. Other site related factors such as

management, the presence or absence of alarms or fail-

safe devices, and the effectiveness of existing primary

containment and any secondary containment relate to

the risk of release of pollutant.

• Pathway: the means by which any pollutant can escape to the

aquatic environment (including both surface and

groundwater). Pathways may be internal (i.e. within the

boundaries of the site) or external.

The assessment defines the pathway in terms of low,

moderate or high transport potential, i.e. short runoff time

between source and surface water or direct drainage

links between source and receiving water or treatment

plant.

• Receptor: humans, animals, fish, plants and biota which would be

affected (directly or indirectly) by the escape of the

pollutants to the receiving water.

The assessment defines the receptor in terms of low,

moderate or high damage potential, i.e. Waters used

extensively for recreational purposes or treatment works

whose function could be adversely affected or whose

capacity overwhelmed by a release of pollutant.

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Evaluating the Environmental Risk

Table C5: Consequence of a fire occurring

Rating

/Score

Category Description

1 Trivial No damage or negligible change to the environment

2 Minor Minor impact/localised or nuisance

3 Moderate Moderate damage to the environment

4 Major Severe damage to the environment

5 Massive Massive damage to a large area, irreversible in medium

term

Frequencies are assigned into bands 1 to 5 using the following scheme:

Table C6: Likelihood of a fire occurring

Rating/

Score

Category Description

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

2 Low Low chance of hazard occurring in 30 yr period

3 Medium Medium chance of hazard occurring in 30 yr period

4 High High chance of hazard occurring in 30 yr period

5 Very High Greater than 50% chance of occurring in 30 yr period

By summing the frequency of events for each consequence or severity level, a

picture of the overall risk on the site may be obtained. The overall cumulative

frequency can be predicted for each severity level and then compared against an

appropriate risk matrix as shown below.

Table C7: Environmental Risk Assessment Matrix

Representative

Frequency

Severity Level

1 2 3 4 5

5 5 10 15 20 25

4 4 8 12 16 20

3 3 6 9 12 15

2 2 4 6 8 10

1 1 2 3 4 5

Note:

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1. High Priority: This level of risk could represent an intolerable risk under the company

risk criteria. Action must be taken to reduce the risk to below the intolerable level.

Risks must be brought to the immediate attention of the site.

2. Medium Priority: Priority corrective action should be implemented to reduce the risk

to a lower level. Further studies may be required to determine appropriate risk

reduction measures. Remaining at this level requires concurrence with the site that

the overall risk of this event and other related events is as low as reasonably

practicable.

3. Low Priority: The risks indicated are broadly acceptable. Significant corrective action

or further analysis is not required.

Evaluating the Firewater Risk

Table C4 below details the ratings used to evaluate the firewater risk.

Table C4: Firewater Risk Assessment Ratings

Fire Risk

High

(15 or more)

Medium

(5 to 12)

Low

(4 or less)

En

vir

on

men

tal

Ris

k

High High High Medium

Medium High Medium Low

Low Medium Low Low

Note:

1. High: Firewater runoff containment will be required if further risk reduction measures

are not implemented.

2. Medium: Firewater runoff containment may not be required if further risk

reduction measures are implemented.

3. Low: Firewater runoff containment not required.

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ABOUT AECOM In a complex and unpredictable world, where growing demands have to be met with finite resources, AECOM brings experience gained from improving quality of life in hundreds of places. We bring together economists, planners, engineers, designers and project managers to work on projects at every scale. We engineer energy efficient buildings and we build new links between cities. We design new communities and regenerate existing ones. We are the first whole environments business, going beyond buildings and infrastructure. Our Europe teams form an important part of our worldwide network of nearly 100,000 staff in 150 countries. Through 360 ingenuity, we develop pioneering solutions that help our clients to see further and go further. www.aecom.com Follow us on Twitter: @aecom

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Attachment K Decommissioning Management Plan

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Decommissioning Management Plan for AbbVie Final 28th October 2016

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ii

Document Control

Status Draft Final Draft Final Final (rev. 1)

Date 27/04/16 28/09/16 26/10/2016 28/10/2016

Version # 1 2 3 4

Written

Approved

This report has been prepared by Environet Consulting Ireland Ltd, with all appropriate care and diligence within the terms of the Contract with the client. This Contract incorporates our Terms and Conditions and takes account of the resources devoted to it by agreement with the client. We disclaim any responsibility to the client and others in respect of any matters outside the scope of works. This report is confidential to the client and we accept no responsibility to third parties to whom this report, or any part thereof, is made known. Such parties rely on the report at their own risk.

Dungarvan Business Centre Fairlane Shandon Dungarvan Co. Waterford Ireland Tel: 058-51155 Fax: 058-51231 Email: [email protected] www.environet.ie

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http://www.environet.ie/

AbbVie

iii

TABLE OF CONTENTS

1 EXECUTIVE SUMMARY ......................................................................... 5

1.1 Activity Details .................................................................................... 5

1.2 Report Preparation .............................................................................. 5

1.3 Comparison with Previous Plans ...................................................... 5

1.4 Overview of the Plan ........................................................................... 6

1.5 Scoping ................................................................................................ 6

1.6 Cost Summary ..................................................................................... 6

1.7 Financial Provision ............................................................................. 6

1.8 Review .................................................................................................. 6

2 INTRODUCTION ..................................................................................... 7

2.1 Site Description ................................................................................... 7

2.2 Site History .......................................................................................... 8

2.3 Classes of Activity Licensed .............................................................. 9

2.4 Application Requirements ................................................................ 10

3 SITE EVALUATION .............................................................................. 11

3.1 Operator Performance ...................................................................... 11

3.2 Environmental Pathways and Sensitivity ........................................ 12

3.3 Operations ......................................................................................... 13

3.4 Processes .......................................................................................... 14

3.5 Inventory of Main Buildings & Infrastructure ................................. 16

3.6 Inventory of Raw Materials and Products ....................................... 19

3.7 Annual Waste Arisings ..................................................................... 20

3.8 Major Plant & Equipment .................................................................. 22

4 CLOSURE TASKS AND PROGRAMMES ............................................ 26

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5 CRITERIA FOR SUCCESSFUL CLOSURE ......................................... 27

6 CLOSURE PLAN VALIDATION ........................................................... 28

7 CLOSURE PLAN COSTING ................................................................. 29

8 CLOSURE PLAN UPDATE AND REVIEW ........................................... 33

9 RESTORATION/AFTERCARE MANAGEMENT PLAN ........................ 34

10 FINANCIAL PROVISION ...................................................................... 34

SITE LAYOUT PLAN .................................................................................... 35

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1 Executive Summary

1.1 Activity Details

Name: AbbVie Limited

Address: IDA Industrial Estate, Carrigtwohill, Co. Cork

Activity (proposed): 12.2.1 The surface treatment of substances,

objects or products using organic solvents, in

particular for dressing, printing, coating,

degreasing, waterproofing, sizing, painting,

cleaning or impregnating, with a consumption

capacity of more than 150 kg per hour or more

than 200 tonnes per year.

1.2 Report Preparation

This report was prepared on behalf of the operator by Environet Solutions.

Environet Solutions

Dungarvan Business Centre

Dungarvan

Co. Waterford

1.3 Comparison with Previous Plans

This will be the first Decommissioning Management Plan (DMP) for the site as

previously site activities were not specified in the First Schedule to the

Environmental Protection Agency Act 1992, as amended.

Year Cost Financial Instrument Expiry of Financial

Instrument

2016 €2.5M To be agreed with the

Agency

No time limit

Table 1: Decommissioning Management Plan History

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1.4 Overview of the Plan

This DMP was prepared in accordance with the EPA documents ‘Guidance on

Assessing and Costing Environmental Liabilities’, 2014 and ‘Guidance on

assessing and costing environmental liabilities Unit cost rates for verification’,

2014.

1.5 Scoping

Based on all available documentation it has been determined that the site has

no potential long term environmental liabilities and there has been no history

of spillages resulting in soil or groundwater contamination (see Baseline

Report from Bluerock Environmental and Groundwater Monitoring Report

2015 from consultants AECOM in Attachment I.4 of the IE Licence

Application). Therefore, a clean closure is envisioned for the site and neither

restoration nor aftercare management are expected to be required post

closure.

1.6 Cost Summary

The total cost associated with the closure, restoration and aftercare

management of the facility has been estimated to be €2.5M.

1.7 Financial Provision

AbbVie confirms that costs associated with the management of all liabilities

from decommissioning and aftercare will be underwritten. AbbVie will agree

with the EPA the form of financial instrument to be put in place.

Type Description Source/Method

of Quantification

Amount of

Provision

Financial

Instrument

Known liabilities

associated with the

closure of the site

As detailed

in this DMP

As detailed in

Table 10 of this

report

€2.5 M To be agreed with

the Agency

Table 2: Financial Instrument

1.8 Review

This closure and restoration/aftercare plan will be reviewed annually and any

updates will be notified to the EPA.

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2 Introduction

2.1 Site Description

The site is situated approximately 1 km west of the centre of Carrigtwohill, Co.

Cork, a town with a population of approximately 7,000. Carrigtwohill is located

approximately 10km to the east of Cork city and 6km to the west of Midleton.

The existing development has a total building area of approximately 14,000m2

over two stories. The total site area at AbbVie is c. 5 ha. The total

hardstanding area of the site, including buildings’ roofs, roads and paved

ground, is c. 2 ha.

The principal buildings on-site at present are identified below:

Production buildings;

Up-scale facility (process development);

Laboratory;

Product warehouse for storing finished products;

Offices and canteen;

Waste store building;

Chemstore building;

Boiler room;

Effluent treatment facility;

Fire pump house;

Electrical switch-rooms.

Approximately 135 permanent staff are currently employed at AbbVie. Staff

numbers may increase to 175-195 by 2020-2021 following commissioning and

commencement of commercial operations in the new Creon DR Production

building. In addition to the permanent staff, approximately 30-40 contract staff

are routinely on-site supporting projects and commercial volume. The plant

operates a combination of days, 24-hours, five and seven day operations.

AbbVie has a 24-hour security presence on-site at all times. Access to the

facility is controlled via secured access gates.

A Site Layout Plan is included as an appendix to this report and a Site

Location Map is included in Attachment B.2 to the IE Licence Application.

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2.2 Site History

Table 3 gives an overview of many of the main activities and events at the site

since 1978.

Date History

1978 The site was first developed by Island Pharmaceuticals for

blending and packaging of powder form pharmaceuticals.

1987 Jouvenal Manufacturing took over the site.

1988 Jouvenal began production of their anti-biotic nasal.

1997 Warner Lambert acquisitioned Jouvenal Manufacturing.

2000 Pfizer acquisitioned Warner Lambert and used the facility for

storage.

2001 Site was purchased by Fournier Laboratories who expanded the

site by adding a tabletting plant including production,

warehousing, staff & office areas, laboratory, services, security

& utility buildings, tank & assoc. works.

2002 There was more investment with an extension to the main

building to provide additional production rooms & associated

equipment accommodation and extension to boiler house.

2004 The site completed commissioning and went into full production

of Fenofibrate tablets. Further expansion with construction of

new three storey office and laboratory building with enclosed

link corridor to existing facility and a temporary prefabricated

administration building.

2005 Solvay Pharmaceuticals acquisitioned Fournier Laboratories.

2006 There was significant investment and two new production

facilities were constructed. This included the construction of 2

storey extension to existing manufacturing building comprising

of production and plant space and alterations to existing

gowning suite and associated works including drainage, hard

standings, bund, extension to car-parking and roadways and

provision of footpaths.

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Date History

2007 Further investment Construction of first floor laboratory

extension to existing research and development laboratory

building, concrete apron, footpath and associated site works.

2010 Abbott acquisitioned Solvay Pharmaceuticals. Production

continued as before.

2013 AbbVie becomes an independent company.

2016 AbbVie applied to the EPA for an IE Licence.

Table 3: Site Operational History

2.3 Classes of Activity Licensed

AbbVie is applying for an IE licence to the EPA for the following activity;

12.2.1 The surface treatment of substances, objects or products using

organic solvents, in particular for dressing, printing, coating,

degreasing, waterproofing, sizing, painting, cleaning or impregnating,

with a consumption capacity of more than 150 kg per hour or more than

200 tonnes per year.

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2.4 Application Requirements

The preparation of the Decommissioning Management Plan (DMP) is a

requirement under the IE licence Application (the Environmental Liability

Directive (2004/35/EC):

‘Describe the existing or proposed measures to minimise the impact

on the environment after the activity or part of the activity ceases

operation, including provision for post-closure care of any potentially

polluting residuals.

There is an explicit requirement in EU and Irish law for financial

provision for landfills and extractive waste facilities. For new activities

subject to the requirements of the Landfill Directive (1999/31/EC) and

the Extractive Waste Directive (2006/21/EC) that are not already

licensed by the Agency, state whether the following have been

prepared:

- an Environmental Liabilities Risk Assessment (ELRA);

- a Closure, Restoration and Aftercare Management Plan

(CRAMP); and

- a proposal for Financial Provision that covers all liabilities

identified in the ELRA and CRAMP.

Regard should be had by applicants to relevant Agency guidance on

these matters.

The Agency may prioritise other sectors (e.g. contaminated land, risk

of waste facility closure liabilities, risk based on Seveso classification)

and require the preparation of a proposal for financial provision before

making a decision on a licence application. Applicants are advised to

discuss the requirement for financial provision with the Agency prior to

making an application.’

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3 Site Evaluation

3.1 Operator Performance

The AbbVie site operates an Environmental Management System certified to

ISO 14001, Health and Safety Management System certified to OHSAS

18001 and Energy Management System certified to ISO 50001.

AbbVie is committed to implementing and employing the highest EHS

standards. Environmental awareness is a priority of the company. The

Environmental Health & Safety (EHS) Manager and EHS Department ensures

that day-to-day operations of the facility are conducted with minimal risk of

harm to humans and the environment.

AbbVie prepares an annual Environmental Management Programme, which is

fully integrated into the site management system. Targets are set, for between

one and five years, for the programme objectives. At the end of each year the

progress against the targets is formally reviewed at senior management level.

The programmes are adjusted as required in the light of ongoing experience

and advances in knowledge and technology. Targets and goals in the

programmes are set to ensure that resources and systems are put in place to

achieve the targets. The success of the programme is measured by the

effectiveness of the systems installed, as well as results in meeting targets. A

copy of the Annual Environmental Report is made available on request to the

general public.

Prior to the issuing of an IE Licence, the site’s activities, in terms of effluent

management and the resulting wastewater discharges, have been deemed

appropriate to be licenced under Section 16 of the Local Government (Water

Pollution) Acts 1977 to 2007. The site currently operates under a Discharge to

Sewer (DTS) License from Irish Water; Licence Number (Reg. Ref.): IW-DTS-

685667-01 which was issued in 2014. Previous to this, the site operated under

a Trade Effluent Licence issued by Cork County Council (Licence No. W.P (S)

09/05).

In general, Environet Solutions found the site to be very well managed and

highly compliant with the requirements of its DTS Licence.

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3.2 Environmental Pathways and Sensitivity

The bedrock geology in the area consists of Dinantian Lower Impure

Limestones and Dinantian Pure Unbedded Limestones. Groundwater

vulnerability is classified as High (on a scale of Low, Moderate, High,

Extreme) and is located on a gravel aquifer which has been classified as

Regionally Important - Karstified (diffuse) (Rkd). In general groundwater is

assumed to follow the local topographical gradient, migrating southward and

ultimately discharging to Cork Harbour. There are no discharges to ground

from the AbbVie facility.

A stream (Tibbotstown 010) runs north to south through the industrial estate

(within 100m of the site) from Anngrove to join the Slatty Water at Slatty

Bridge, 800 m south of the site. The EPA Map Viewer lists the River

Waterbody WFD status this stream as ‘unassigned’. There are no emissions

from the site to this stream.

The site discharges pre-treated process effluent to County Council Sewer.

Surface waters are continuously monitored and discharged, via the local

authority network, to the Slatty River Estuary (Slatty Water) which in turn

feeds into the Great Island Channel, part of Cork Harbour.

Uncontaminated surface water is discharged, via the Local Authority

stormwater sewer, to the Slatty Water which is situated approximately 800m

southwest of the site. Slatty Water is part of the Great Island Channel Special

Area of Conservation (site code 001058), the Cork Harbour Special Protection

Area (site code 004030) and is a proposed Natural Heritage Area. The Slatty

Waters are part of Lough Mahon which itself forms part of Cork Harbour.

Lough Mahon has a Transitional Waterbody WFD Status 2010-2012

designation of Poor.

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3.3 Operations

The operation is a modern bulk tablet finish facility, manufacturing solid and

capsule formulation using state-of-the-art technology. The facility specialises

in Active Pharmaceutical Ingredient (API) particle size reduction resulting in

lower dosage formulations. The highly sophisticated technology on-site

enables delivery of products and processes from small scale clinical trial

supply to larger commercial manufacturing. AbbVie’s focus is on developing

medicines that can provide strong clinical performance, measurable patient

benefit and economic value, particularly in areas where there is significant

need, such as hepatitis C, neuroscience, immunology, oncology, chronic

kidney disease, cardiovascular disease and women’s health.

The processes employed on-site include milling, blending, granulation, drying,

sieving, tableting, coating and packaging. The site also operates a 1/10th

scale-up facility.

Most of the raw materials used for production are solids (powder or granules)

which are mixed with purified water or solvent. Currently, the facility is used

for the commercial manufacture of six solid oral dose products for human use:

TriCor - is a film coated tablet manufactured in two dosage

strengths (145mg and 48mg)

TriLipix - is manufactured as a 135mg and 45mg capsule

Kaletra - is a single strength film coated tablet (200mg/ 50mg)

Cholib - is a film coated tablet manufactured in two dosage

strengths 145/20 mg and 145/40 mg

Viekirax - is a single strength film coated tablet (12.5/75/50 mg)

Aluvia - is a Red film coated tablet, manufactured in one strength,

200mg/50mg.

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3.4 Processes

The processes employed on-site include milling, blending, granulation, drying,

sieving, tableting, coating and packaging. A generic description of the current

processes used in the manufacture of the existing products is as follows:

Material Purchasing

Receipt to Warehouse

Sampling and Testing

Dispensing

Milling

Sieving

Blending

Compression into tablets

Coating of tablets

Packing

Receipt into Warehouse

Material Purchase

The first step is to purchase the Raw Material. The purchasing department

carries out this function by placing a purchase order with the supplier.


On receipt of delivery the material is received into the warehouse. It is visually

inspected by the Warehouse Operator. The Warehouse Operator enters the

material details onto SAP and labels the material as per Goods Receipt from

Suppliers procedure.

Sampling/Testing by Quality Control

The material is sampled by the Quality Control department in accordance with

Sampling of Raw Materials procedure. The material is tested and assigned a

status in accordance with the Receipt, Testing & Approval of Samples in the

QC Laboratory procedure. Once the material is assigned a status by the

Quality Department, the material is placed in the appropriate location.

Dispensing

The material is now available to be dispensed. Dispensing is carried out in

accordance with general dispensing procedure. The residual weight (where

applicable) is calculated, and attached to the container.

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Batch Assembly

Materials that have been dispensed are correctly labelled and held in the

designated batch assembly area until further processing occurs.

Milling/ Nano-milling

The dispensed extrudate is milled in the mill in accordance with the appropriate procedure to reduce the particle size.

Sieving/Sifting

A portion of the milled extrudate along with the dispensed quantities of other

required raw materials are sieved or sifted and then combined with the

remaining milled extrudate.

Blending

The mixture is charged to an IBC and then blended with extranular excipients

to afford blended material suitable for compression into a matrix tablet. The

Blend is then weighed.

Compression

This blend is then compressed to form uncoated tablets. Tests for weight

(individual and average), hardness, thickness and visual are performed on the

uncoated tablets to ensure they are of the correct quality.

Coating

The uncoated tablets are coated in accordance with the relevant procedural

method. The tablets are tested for mass and are also visually inspected during

the coating process.

Packing

The Finished Product tablets or capsules are packed in accordance with

packaging procedures.


The finished products are received into the warehouse.

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3.5 Inventory of Main Buildings & Infrastructure

The table below lists the main buildings located at the facility. During the site

audit there was no evidence of asbestos containing materials being present in

roofing materials or pipe lagging. Site management confirmed that to their

knowledge asbestos containing materials are not present at the site.

Building Construction Area

Sq.m Activity

Ground Floor

WH1 Production

Building

Steel frame & 70mm Kingspan profile

insulated PIR cladding

760 Production

Boiler House Steel frame & 70mm Kingspan profile


385 Power and heat

generation

Offices Concrete block 530 Administration

Warehouse Concrete block with single skin external

cladding facade

2,480 Storage

Transit Area Steel frame & 70mm Kingspan profile


365 Goods In/Out

Scale-up Facility Cleanroom panel with Rockwool fill 405 Product

Development

Waste

Compound

Steel frame & single skin profile cladding 360 Waste Storage

Offices &

Canteen

Portacabin structures 840 Storage

Trilpix & Train B

Production

Cleanroom panel, steel stud with 3mm

sheetrock. Steel frame with PIR insulated

cladding external.

3,220 Production

Creon Dr

Production (due

for completion

early 2018)

Cleanroom panel, steel stud with 3mm

sheetrock. Steel frame with PIR insulated

cladding external.

1,808 Production

Security & First

Aid Building

Concrete block & 70mm Kingspan profile

insulated PIR cladding.

72 Site Security &

First Aid

First Floor

QC Laboratories

& Offices

Roof: 50mm steel deck with I x layer PIR

insulation and 2 x layers of torch-on felt

Walls: Concrete block with metal stud

partition (internal). 70mm Kingspan profile

insulated PIR cladding (external).

Floor: Concrete slab

1,005 Quality Control

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Building Construction Area

Sq.m Activity

Equipment Room Roof: 50mm steel deck with I x layer PIR

insulation and 2 x layers of torch-on felt

Walls: 70mm Kingspan profile insulated PIR

cladding (external).

Floor: Concrete slab

3,380 Production

Total 15,610

Table 4: Inventory of Main Buildings

AbbVie keeps an inventory of all process tanks on-site. Table 5 below lists all

external tanks on-site and Table 6 lists all internal tanks on-site. All laboratory

chemicals are stored within designated self-contained flame proof cabinets

with the laboratories and are not included in the tank inventory in Table 6

below.

Location Description Capacity (litres)

External Fire Water Tank 500,000

External Virgin Acetone solvent (proposed) 30,000

External Effluent Holding Tank (proposed) 30,000

External Diesel tank 1 1,500

External Diesel tank 2 1,500

Table 5: External Tanks

Tank Description Construction Material

Contained

Capacity

(litres)

CIP Holding Tank Stainless Steel CIP washings 450

CIP Holding Tank Stainless Steel CIP washings 450

Nitrogen Skid Tank Carbon Steel Nitrogen gas 750

Nitrogen Skid Tank Stainless Steel Nitrogen gas 750

Nitrogen Skid Tank Stainless Steel Nitrogen gas 2,000




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Tank Description Construction Material

Contained

Capacity

(litres)

Purified Water Skid Tank Stainless Steel Purified Water 100

Purified Water Skid Tank Stainless Steel Purified Water 10,000










Nitrogen Skid Tank Stainless Steel Nitrogen gas 230

Chilled Water Tank Stainless Steel Purified Water 15,000

R25 M101-TA-001 Stainless Steel TBC 1,000

R26 M104-TA-002 Stainless Steel Water 1,000

R204 M302-TA-007 Stainless Steel Slurry Prep. 1,700

R204 M302-TA-004 Stainless Steel Slurry Prep. 450


R205 M302-TA-002 Stainless Steel TBC 1,000






Solution Prep Tanks x 6 Stainless Steel Aqueous based

coating solution

200

R94 Condensate Tank (U-801-CL-001) Stainless Steel Condensate 500

R94 Hot Water Cylinder (U-801- CL-001) Stainless Steel Water 1,000

Glycol Tank - Plant Room Stainless Steel Water 21,700

Purified Water Tank Plant Room - U58 -1 Stainless Steel Purified water 10,000

Table 6: Internal Tanks

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3.6 Inventory of Raw Materials and Products

Table 7 below is an estimate of raw material stored on-site.

In order to arrive at an estimated cost of waste removals it has been

conservatively assumed that 100% of the raw materials inventory, chemicals

and fuels will need to be removed as part of the DMP process.

It is envisaged that all finished products will be shipped to an AbbVie sales

distribution centre as part of the decommissioning process.

Type Hazardous

(Y/N)?

Storage Area Storage Type Maximum

Storage

Capacity

(tonnes)

Disposal/

Recovery

Option

Solvents Y Chemical Store

& Tank

Bunded Tank &

Store

30 Disposal/

Recovery

Cleaning Materials Y Cleaning Store Chemical Cabinets

& Bunded Pallets

4 Disposal/

Recovery

Equipment

Lubricants

Y Chemical Store Bunded Store 0.5 Disposal/

Recovery

Raw Materials N Warehouse Palleted

Warehouse

200 Disposal/

Recovery

API Raw Material Y Warehouse Palleted

Warehouse

65 Disposal/

Recovery

Finished Product N Warehouse Palleted

Warehouse

10 Shipped to

Customers

Laboratory

Chemicals

Y Labs Flammables

Cabinets

2 Disposal/

Recovery

Effluent Treatment

Chemicals

Y WWTP Bunded Tank 2 Disposal/

Recovery

Fuels Y External Double skinned

tank

3 Disposal/

Recovery

Packaging N Warehouse Palleted

Warehouse

10 Disposal/

Recovery

Table 7: Inventory of Materials

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3.7 Annual Waste Arisings

Table 8 below contains a list of all waste materials generated at the site in

2015. For the purposes of the DMP we assume that 50% of this material will

require disposal in a closure scenario.

Waste Description EWC Code Hazardous

(Y/N)

Quantity

produced

t/annum

Sodium and potassium hydroxide 06 02 04* Y 0.349

Other bases 06 02 05* Y 0.005

Other organic solvents, washing liquids and mother

liquors

07 05 04* Y 0.456

Solid wastes containing hazardous substances 07 05 13* Y 50.518

Wastes not otherwise specified 13 08 99* Y 0.026

Paper and cardboard packaging 15 01 01 N 9.180

Plastic packaging 15 01 02 N 10.540

Packaging containing residues of or contaminated by

hazardous substances

15 01 10* Y 0.596

Absorbents, filter materials (including oil filters not

otherwise specified), wiping cloths, protective clothing

contaminated by hazardous substances

15 02 02* Y 10.934

Discarded equipment containing hazardous

components1 other than those mentioned in 16 02 09

to 16 02 12

16 02 13* Y 1.042

Inorganic wastes containing hazardous substances 16 03 03* Y 0.164

Organic wastes containing hazardous substances 16 03 05* Y 1.928

Organic wastes other than those mentioned in 16 03

05

16 03 06 N 2.720

Gases in pressure containers (including halons)

containing hazardous substances

16 05 04* Y 0.012

Laboratory chemicals, consisting of or containing

hazardous substances, including mixtures of

laboratory chemicals

16 05 06* Y 0.613

Discarded inorganic chemicals consisting of or


16 05 07* Y 0.013

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Waste Description EWC Code Hazardous

(Y/N)

Quantity

produced

t/annum

Discarded organic chemicals consisting of or


16 05 08* Y 24.912

Peroxides, for example hydrogen peroxide 16 09 03* Y 0.039

Wastes whose collection and disposal is subject to

special requirements in order to prevent infection

18 01 03* Y 0.006

Biodegradable kitchen and canteen waste 20 01 08 N 7.534

Fluorescent tubes and other mercury-containing

waste

20 01 21* Y 0.077

Mixed municipal waste 20 03 01 N 16.280

Table 8: Annual Waste Arisings

In 2015, total hazardous waste generated at the site was approximately 90

tonnes and total non-hazardous waste was approximately 50 tonnes. Site

Management has confirmed that no PCBs or Asbestos Containing Materials

are expected to be present on-site.

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3.8 Major Plant & Equipment

An inventory of all major plant and equipment is provided in Table 9 below.

Plant/Equipment Location

Sprinkler System Plant Room

Chiller Plant Room

Pre-filter steam air heater Plant Room AHU

Humidifier for process air Plant Room AHU

Dehumidifier for process air Plant Room AHU

Final HEPA Filter for process air Plant Room AHU

Pre-filter steam air heater Plant Room

Humidifier Plant Room

Dehumidifier Plant Room

HEPA Filter Plant Room

LIFT SYSTEM In Main Bldg

Pre Filter steam air heater Plant Room




Pre-filter Steam Air Heater Plant Room




Pre-filter steam air heater Plant Room




Pre filter steam air heater Plant Room




Pre filter steam air heater Plant Room




Pre-filter steam air heater Roof of Labs

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Humidifier Roof of Labs

Dehumidifier Roof of Labs

HEPA Filter Roof of Labs

Purified Water Distribution Loop Plant Room

AHU001 Plant Room

AHU002 Plant Room

AHU003 Plant Room

Chiller Roof

AHU 3501 Plant Room

AHU 901 Plant Room

HVAC Ducting Plant Room

HVAC Ducting Plant Room

Warehouse AHU Warehouse 2

Production Skid Production

VSD Drive Production

CIP System Central Technical Corridor

Wash Water preparation station Central Technical Corridor

Steam Heating System for wash water Central Technical Corridor

Coating Unit Production

Pressurisation Unit Plant Room

Hot Water Skid Plant Room

Chemical Dosing Skid Plant Room

Pumping Skid Plant Room

Loop realisation and UV Boards Plant Room

Tablet Press Production


Post Hoists 1200kg Production

Frame for sifter Production

Post Hoists 1200kg Production

Cond Receiver 2 Eastern Tech Corridor

Post Hoist Eastern Tech Corridor

Sifter Production

Validation Coater Plant Room

Dryer Production

Co-Mill Production

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Fume Hoods Outside Room 67

Compressor 1 Plant Room

Compressor 2 Plant Room

Receiver Plant Room

Dryer 1 Plant Room

Dryer 2 Plant Room

UPS Battery Room Main Bldg - UPS Room

TCM Modules Skids Niro Vessel A Plant Room

TCM Modules Skids Niro Vessel B Plant Room

Top Spray Coater Plant Room


Dust Extraction Plant Room

Tablet Coater Production

IBC Washer Plant Room

Pure Water Storage Vessel Pre Treatment skid 1 Plant Room

Coating Soln. LAF Booth Production

Weigh Scales Technical Corridor

Tablet Press Post Hoist Production

Sifter Room Post Hoist Production

Boiler Boiler Room

Mill Production

Granulator Production

Dryer Production

Dryer Machine Tower Production

Inlet Air Handler Plant Room

Exhaust Air System Plant Room

CIP Skid Plant Room

Capsule Filling Machine Production

Blender Production

Powder Transfer System Production

Post Hoist 1 Central Technical Corridor

Post Hoist 2 Production

Separator Production

Chiller 1 Roof

Chiller 2 Roof

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CIP Skid Pilot Plant


Post Hoist Production

Pre Treatment Skid Plant Room

Nitrogen Generator Plant Room

Nitrogen Plant Skid Plant Room

Compressor Plant Room

Chiller External

Ozone Generator Plant Room

Effluent Pumping Station 1.5M Chamber & Inlets Effluent Building

Dispensary Room Hoist Production

Dispensary Room Hoist Production

QC Fumehood QC Lab

Hoist Production

Nitrogen Generator & Air Compressor Plant Room

Air Compressor QC Lab 3

Mill Production

Nitrogen Skid Plant Room

Hoists Production

Hoists Production

Hoists Production

Biomass Boiler Biomass Boiler House

Mill Production

Comill Production

Table 9: Inventory of All Major Plant and Equipment

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4 Closure Tasks and Programmes

This section focuses on the closure aspects for the activity. The closure plan

includes the decommissioning and decontamination of all of the structures

and the management and safe removal of any residuals arising as a result of

decommissioning.

The purpose of the closure process is to ensure that the site no longer poses

a risk of environment pollution and is considered to be environmentally inert.

It is not envisaged that any of the plant and/or equipment will have to be

demolished. These elements, once decommissioned and decontaminated, will

be tested to ensure there is no risk of environmental pollution remaining. The

following steps will be carried out in sequential order to achieve closure of the

production area of the site:

Decontamination and decommissioning of production buildings using

standard clean in place (CIP) procedures. All wash waters discharged

to Carrigtwohill WWTP for treatment. All residual waste and materials

removed to waste storage areas.

Emptying of warehouses and decontamination of warehouse buildings.

Raw materials, chemicals and fuels labelled and dispatched to waste

storage areas. Finished products will be forwarded to customers.

Emptying, decontamination and decommissioning of tanks. No

residuals to remain in tanks or pipelines. Residuals to be treated on-

site or recovered/disposed off-site at appropriate facilities. Shutdown,

decontaminate and decommission boilers. Residual fuels to be

removed from tanks and pipelines.

Removal of all residual waste to waste storage areas.

Clear and clean all office and administration areas. WEEE to be

removed by suitably permitted operator. All other wastes to be

dispatched to waste storage areas.

It is expected that the above operations will take approximately 26

weeks. Tasks and timings are detailed in Section 7 of this report.

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5 Criteria for Successful Closure

The following criteria have been established to set the benchmark for the

successful closure of the site:

All plant will be safely decontaminated using standard procedures and

trained personnel;

All waste will be handled, packaged, temporarily stored, recovered

and/or disposed of in a manner which complies with regulatory

requirements and best practice;

All relevant records relating to movement, transfer or disposal of waste

will be managed and retained throughout the closure process and will

be available for review by the EPA;

No soil within the site boundary will be contaminated to a level that

poses a risk to human health or neighbouring properties;

Access to monitoring locations will be maintained at all times during the

closure process;

The site will remain in compliance with its IE licence during the closure

process and until the date of licence surrender;

That any remaining issues are closed out in a timely manner following

the EPA site closure audit;

That the site is left in an environmentally inert state;

That sufficient funds are available to cover the full cost of closure.

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6 Closure Plan Validation

Once the closure plan has been implemented the licensee will arrange for an

Independent Closure Audit (ICA) to be carried out by an independent third

party consultant. The qualification and experience of the independent auditor

will be provided and agreed with the EPA prior to the ICA commencing. The

scope of the audit will be agreed in advance with the EPA and, following

approval, the chosen independent auditor will complete the validation audit.

The completed Validation Audit report will be submitted to the EPA for

approval.

The EPA may then elect to carry out a final closure audit to verify compliance.

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7 Closure Plan Costing

Closure plan costing is presented in Table 10 below:

Task Description Quantity Unit Unit Rate (€)

Cost (€) Source

Plant & Equipment Decontamination Tank decontamination 1–5 tonne 20 unit 1 1,200 24,000 AbbVie

Tank decontamination 5–20 tonne 1 unit1 2,500 2,500 AbbVie

Tank decontamination 20-50 tonne 5 unit1 6,000 30,000 AbbVie

Tank decontamination 50–100 tonne 1 unit1 10,000 10,000 AbbVie

Decontamination of utilities (chillers, boilers, cooling towers, generators, transformers, etc.)

10 day 2 2,400 24,000 AbbVie

In-situ bunds 5 day 2,200 11,000 AbbVie

Misc. Chemical & Storage Tanks 5 day 2,200 11,000 AbbVie

Decontamination of Buildings/Areas Creon DR Production 10 day 2,200 22,000 AbbVie

Trilpix Production 10 day 2,200 22,000 AbbVie

Train B Production 10 day 2,200 22,000 AbbVie

Scale-up Facility 5 day 2,200 11,000 AbbVie

QC Laboratories 5 day 2,200 11,000 AbbVie

Equipment Room 5 day 2,200 11,000 AbbVie

Air Abatement Equipment 10 day 2,200 22,000 AbbVie

Boiler House 2 day 2,200 4,400 AbbVie

Site Drainage Cleaning 6 day 2,200 13,200 AbbVie

Decommissioning of Buildings/Areas Trilpix Production 20 day 2,200 44,000 Mech. Contractor

Train B Production 20 day 2,200 44,000 Mech. Contractor

1 Assumes 1 supervisor & 3 operatives 2 Assumes 1 supervisor & 5 operatives

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Cost (€) Source

Creon DR Production 20 day 2,200 44,000 Mech. Contractor

Scale-up Facility 20 day 2,200 44,000 Mech. Contractor

QC Laboratories 10 day 2,200 22,000 Mech. Contractor

Equipment Room 10 day 2,200 22,000 Mech. Contractor

Air Abatement Equipment/HVAC 20 day 2,200 44,000 Mech. Contractor

Thermal Oxidiser 10 day 2,200 22,000 Mech. Contractor

Boiler House 10 day 2,200 22,000 Mech. Contractor

Wastewater Treatment Plant Equipment 5 day 2,200 11,000 Mech. Contractor

Plant & Equipment Transport & Disposal

WEEE Removal 40 tonne 60 2,400 Mech. Contractor

Plant & Equipment transport 250 tonne 60 15,000 Mech. Contractor

Recovery cost (note nil cost) 290 tonne - - Mech. Contractor

Non-Hazardous & Hazardous Waste

Removal (>1 tonne) 3 Non-halogenated organic solvents, washing liquids and mother liquors 4 0.5 tonne 450 225 Waste Contractor

solid wastes containing hazardous substances 25.3 tonne 400 10,120 Waste Contractor

paper and cardboard packaging 4.6 tonne 100 460 Waste Contractor

plastic packaging 5.3 tonne 100 530 Waste Contractor

absorbents, filter materials (including oil filters not otherwise specified), wiping cloths, protective clothing contaminated by hazardous substances

5.5 tonne 700 3,850

Waste Contractor

organic wastes other than those mentioned in 16 03 05

1.4 tonne 400 560 Waste Contractor

discarded organic chemicals consisting of or containing hazardous substances

12.5 tonne 450 5,625 Waste Contractor

biodegradable kitchen and canteen waste 3.8 tonne 100 380 Waste Contractor

3 Assuming 50% of waste arisings for the year will require removal 4 Assuming the max. volume that can be stored on-site is 30 m3

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Cost (€) Source

mixed municipal waste 8.1 tonne 100 810 Waste Contractor

Residual waste from decontamination Phase 200 tonne 350 70,000 Waste Contractor

Materials Removal

Off-site transport and disposal/recovery of residual fuels

3 tonne 130 390 Waste Contractor

Solvents, chemicals & lubricants disposal/recovery

35 tonne 450 15,750 Waste Contractor

API Raw Materials disposal 65 tonne 200 13,000 Waste Contractor

Raw Materials disposal/recovery 200 tonne 120 24,000 Waste Contractor

Packaging disposal/recovery 10 tonne 100 1,000 Waste Contractor

Environmental Monitoring Wastewater Monitoring (Weekly) 26 sample 320 8,320 AECOM

Post-closure groundwater sampling 2 sample 2,600 5,200 AECOM

Validation Audit Consultant 9 day 900 8,100 Environet

Management Costs Utilities (assuming production has ceased) 6 month 50,000 300,000 AbbVie

Security 6 month 12,500 75,000 AbbVie

Management 6 month 15,000 90,000 AbbVie

Administration 6 month 12,000 72,000 AbbVie

Rates 6 month 15,000 90,000 AbbVie

External sware/hware 6 month 9,000 54,000 AbbVie

Insurance 6 month 18,750 112,500 AbbVie

Canteen 6 month 6,500 39,000 AbbVie

Safety Costs 6 month 10,000 60,000 AbbVie

IE Licence Licence surrender fee 1 item 8,888 8,888 EPA

SUB-TOTAL 1,657,208

Plus 50% Contingency 828,604

TOTAL 2,485,812

Table 10: Closure Plan Costing

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The schedule for site closure and remediation works is summarised below:

Table 11: Gantt Chart

Action Wk. 2 Wk. 4 Wk. 6 Wk. 8 Wk. 10 Wk. 12 Wk. 14 Wk. 16 Wk. 18 Wk. 20 Wk. 22 Wk. 24 Wk. 26

Cease production

Notify EPA and Cork County Council of closure

Post-closure environmental monitoring; wastewater &

groundwater sampling

Decontaminate any plant/equipment

Arrange for all waste to be taken off-site and

recycled/disposed in an appropriate manner

Arrange for sale/recycling of plant/ equipment

Arrange for sale/disposal of any product or raw materials

located at the site at the time of closure

Internal Closure Validation audit carried out by or on

behalf of AbbVie

External closure audit by the EPA

Closure Validation Certification issued by the EPA to

indicate formal acceptance of the closure of the site.

Surrender the IE Licence to the EPA

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8 Closure Plan Update and Review

As per typical IE licence requirements:

‘The plan shall be reviewed annually and proposed amendments thereto

notified to the Agency for agreement as part of the AER. No amendments

may be implemented without the agreement of the Agency.’

AbbVie confirms its intention to review and update the DMP annually and to

inform the EPA of any changes thereto.

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9 Restoration/Aftercare Management Plan

As the most recent Groundwater Monitoring Report by consultants AECOM

and baseline report by consultants Bluerock Environmental has concluded

that there are no significant groundwater contamination issues at the site it

has been decided that the site will opt for a ‘Clean Closure’. Therefore, other

than the requirement to continue to monitor wastewater and surface water

emissions until the licence is surrendered and the management costs

associated with the site, there are not expected to be any other significant

aftercare costs.

10 Financial Provision

AbbVie has agreed to cover the closure liabilities identified in this report by

way of a financial instrument to be agreed with the Agency.

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Site Layout Plan

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TEL 021-4396960 E-MAIL [email protected] WEB www.fgcl.ie2a RIVER HOUSE, BLACKPOOL PARK, BLACKPOOL, CORK.

CONSULTING ENGINEERS

NOTES:

1. ALL LEVELS RELATE TO ORDNANCE SURVEY

DATUM, MALIN HEAD

2. CO-ORDINATES TO IRISH GRID PROJECTION

LEGEND:

SITE BOUNDARY

FOURNIER LABORATORIESIRELAND LTD.,

IDA Industrial Estate, Carrigtohill,County Cork, Ireland.

A

CREON OPTIMISED

1000 SITE LAYOUT PLAN

16415-L-03

SITE LAYOUT PLAN

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Attachment L

Statutory Requirements

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ii

Table of Contents

1 STATUTORY REQUIREMENTS .............................................................. 1

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1

1 Statutory Requirements

The following describes how the facility will comply with the requirements as

specified in Section L of the IE Application Form. The questions in the

application form are in italics below.

Indicate how the requirements of section 83(5)(a)(i) to (v) and (vii) to (xa)

of the Act of 1992 shall be met, having regard, where appropriate, to any

relevant specification issued by the Agency under section 5(3)(b) of that

Act or any applicable best available techniques (BAT) conclusions

adopted in accordance with Article 13(5) of the Industrial Emissions

Directive and the reasons for the selection of the arrangements

proposed. Namely;

83(5)(a)(i) any emissions from the activity will not result in the

contravention of any relevant air quality standard specified under

section 50 of the Air Pollution Act 1987, and will comply with any

relevant emission limit value specified under section 51 of the Air

Pollution Act 1987.

The facility will not lead to a contravention of the above ambient air quality

standards and emissions limit values specified above will be complied with.

An Air Dispersion Modelling Report has been provided in Attachment I and

confirms compliance with statutory emission limit values and ambient air

standards.

83(5)(a)(ii) any emissions from the activity will comply with, or will not

result in the contravention of, any relevant quality standard for waters,

trade effluents and sewage effluents and standards in relation to

treatment of such effluents prescribed under section 26 of the Local

Government (Water Pollution) Act 1977.

The facility will comply with the above legislation. Process effluent is sent to

Carrigtwohill WWTP following pre-treatment on-site. Emissions will be in

compliance with the emission limit values specified in the IE Licence. Clean,

uncontaminated storm water is discharged, via petrol interceptors to Slatty

Water which discharges to Lough Mahon, part of Cork Harbour. It is AbbVie’s

intention to install automated slam shut valves linked to the fire pump control

panel for use in the event of an emergency to prevent fire water run-off

entering the stormwater network.

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83(5)(a)(iii) any emissions from the activity or any premises, plant,

methods, processes, operating procedures or other factors which affect

such emissions will comply with, or will not result in the contravention

of, any relevant standard including any standard for an environmental

medium prescribed under regulations made under the European

Communities Act 1972, or under any other enactment,

The facility will not lead to a contravention of any relevant standards

prescribed under the European Communities Act 1972, or under any other

enactment. There are no predicted significant impacts associated with the

proposed facility.

83(5)(a)(iv) any noise from the activity will comply with and will not

result in the contravention of, any regulation under section 106.

As detailed in Section I.7 of this application, noise from the activity will comply

with, or will not result in the contravention of, any regulations under section

106.

83(5)(a)(v) any emissions from the activity will not cause significant

environmental pollution.

Emission from the activity will not cause significant environmental pollution. A

full assessment of environmental impacts has been detailed in Section I of the

application.

83(5)(a)(vii) having regard to Part III of the Act of 1996, production of

waste in the carrying on of the activity will be prevented or minimised or,

where waste is produced, it will be recovered or, where that is not

technically or economically possible, disposed of in a manner which will

prevent or minimise any impact on the environment,

The facility will comply with the provisions of the Act of 1996. This will be

achieved through the implementation of BAT and waste management best

practice.

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(viia) without prejudice to subparagraph (vii), waste generated in the

carrying on of an industrial emissions directive activity, in order of

priority in accordance with section 21A (inserted by Regulation 7 of the

European Communities (Waste Directive) Regulations 2011) of the Act of

1996, will be prepared for re-use, recycled, recovered or, where that is

not technically or economically possible, disposed of in a manner which

will prevent or minimise any impact on the environment,

The proposed facility has been designed in accordance with the relevant

sectoral BAT guidance (see section I.8). Its operation will be in accordance

with an Environmental Management System and appropriate specific

operating procedures. AbbVie is committed to compliance with the Waste

Management Act 1996 as amended and its associated regulations, and as

such will ensure production of waste will be minimised. Where waste

generation is unavoidable, waste will be recovered or disposed in the most

advantageous means possible in line with the current Waste Hierarchy.

83(5)(a)(viii) energy will be used efficiently in the carrying on of the

activity.

Energy efficiency is a critical part of design considerations and ongoing

operations at the facility. Refer to Attachment G.2 of this application.

83(5)(a)(ix) necessary measures will be taken to prevent accidents in the

carrying on of the activity and, where an accident occurs, to limit its

consequences for the environment and, in so far as it does have such

consequences, to remedy those consequences.

All measures are taken to prevent and limit the severity of accidents at the

facility. Refer to Attachment J of this application.

83(5)(a)(x) necessary measures will be taken upon the permanent

cessation of the activity (including such a cessation resulting from the

abandonment of the activity) to avoid any risk of environmental pollution

and return the site of the activity to a satisfactory state.

Decommissioning management costs have been estimated and the site will

be returned to an environmentally inert state in the event of closure. Refer to

Attachment K of this application.

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(xa) in the case of an industrial emissions directive activity, necessary

measures referred to in subparagraph (x) including measures of

appropriate duration shall be taken in accordance with section 86B,

A soil and groundwater baseline report has been provided with Section I.4 of

this application and in combination with the DMP report provided in Section K

will enable AbbVie take the necessary measures required by Section 86B.

Indicate whether or not the activity is carried out, or may be carried out,

or is located such that it is liable to have an adverse effect on –

(a) a site placed on a list in accordance with Part 3 of S.I. 477 of 2011, or

(b) a site where consultation has been initiated in accordance with

Article 5 of the EU Habitats Directive (92/43/EEC).

Undertake a screening for Appropriate Assessment and state whether

the activity, individually or in combination with other plans or projects,

is likely to have a significant effect on a European Site(s), in view of best

scientific knowledge and the conservation objectives of the site(s).

Where it cannot be excluded, on the basis of objective scientific

information, following screening for Appropriate Assessment, that an

activity, either individually or in combination with other plans or

projects, will have a significant effect on a European Site, provide a

Natura Impact Statement, as defined in Regulation 2(1) of the European

Communities (Birds and Natural Habitats) Regulations (S.I. No. 477 of

2011). Where based on the screening it is considered that an

Appropriate Assessment is not required, provide a reasoned response.

The proposed site is not protected under SAC, SPA, NHA or pNHA

designation. The closest protected site is the Slatty Water to which the site

discharges uncontaminated surface waters. The Slatty Water is designated as

a SAC and SPA. An Appropriate Assessment prepared by Moore Group

Environmental Services is included in Section B.6 of the IE application. It is

not expected that the activity will have any impact on this area.

Indicate whether or not the activity is liable to have an adverse effect on

water quality in light of the European Communities Environmental

Objectives (Surface Water) Regulations 2009 (S.I. No. 272 of 2009).

The activity is not expected to have any adverse impact on surface water

quality. Process effluent is treated onsite prior to discharge in compliance with

emission limit values to Carrigtwohill municipal wastewater treatment plant.

Only uncontaminated surface water is discharged directly to the Slatty Water.

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Indicate whether or not the activity is liable to have an adverse effect on

water quality in light of the European Communities Environmental

Objectives (Ground Water) Regulations 2010 (S.I. No. 9 of 2010).

There are no direct discharges to ground from the activity. Preventative

measures which are in place at the AbbVie site include full secondary

containment (bunding) of all internal and external vessels containing

potentially polluting materials.

Indicate whether any of the substances specified in the Schedule of the

EPA (Industrial Emissions) (Licensing) 2013, S.I. No. 137 of 2013, are

discharged by the activity to the relevant medium.

The following substances will be emitted to atmosphere in accordance with

appropriate emission limit values:

Oxides of nitrogen and other nitrogen compounds.

Carbon monoxide.

Volatile organic compounds.

Dust including fine particulate matter.

The following substance will be emitted to sewer in accordance with

appropriate emission limit values:

Materials in suspension.

Substances which contribute to eutrophication (in particular, nitrates

and phosphates).

Substances which have an unfavourable influence on the oxygen

balance (and can be measured using parameters such as BOD, COD,

etc.).

Indicate if the best environmental practices are in place for control of

diffuse emissions from the installation as set out in the following

legislation:

(a) a BAT Conclusions Implementing Decision published by the EC.

Best Available Techniques are in place at the facility. Please refer to

Attachment I.8

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(b) a specification prepared by the Agency in accordance with

Section 5 of the Environmental Protection Agency Act 1992 as

amended;

Best Available Techniques are in place at the facility. Please refer to

Attachment I.8

(c) the Urban Waste Water Treatment Regulations 2001 (S.I. No. 254

of 2001) as amended by the Urban Waste Water Treatment

(Amendment) Regulations 2004 (S.I. No. 440 of 2004) or any future

amendment thereof;

While not directly applicable treated effluent from the facility is discharged to

the Carrigtwohill municipal wastewater treatment plant. However, it is

considered that this will have no significant impact on the municipal plant due

to the relatively small nature of the discharge.

(d) the European Communities (Good Agricultural Practice for

Protection of Waters) Regulations 20 (S.I. No. 610 of 2010) or any

future amendment thereof;

Not applicable.

(e) the Local Government (Water Pollution) Act, 1977 (Control of

Cadmium Discharges) Regulations 1985 (S.I. No. 294 of 1985);

Not applicable.

(f) the Local Government (Water Pollution) Act, 1977 (Control of

Hexachlorocyclohexane and Mercury Discharges) Regulations

1986 (S.I. No. 55 of 1986);

Not applicable.

(g) the Local Government (Water Pollution) Acts, 1977 and 1990

(Control of Carbon Tetrachloride, DDT and Pentachlorophenol

Discharges) Regulations 1994 (S.I. No. 43 of 1994); and,

Not applicable

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(h) measures or controls identified in a pollution reduction plan for

the river basin district prepared in accordance with Part V of the

EC Environmental Objectives (Surface Waters) Regulations 2009

S.I. No. 272 of 2009 for the reduction of pollution by priority

substances or the ceasing or phasing out of emissions,

discharges and losses of priority hazardous substances.

The proposed facility will not discharge priority substances as outlined in EC

Environmental Objectives (Surface Waters) Regulations, SI 272 of 2009.

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