For

insp

ectio

n pur

pose

s only

.

Conse

nt of

copy

right

owne

r req

uired

for a

ny ot

her u

se.

EPA Export 25-07-2013:20:16:19

GLAXOSMITHKLINE (CORK) LTD.

IPC LICENCE NO. P0004-02

IPPC Licence Review Application Form September 2006

Volume I of I

EPA Submittal Date: September 30st 2006

For

insp

ectio

n pur

pose

s only

.

Conse

nt of

copy

right

owne

r req

uired

for a

ny ot

her u

se.

EPA Export 25-07-2013:20:16:19

Integrated Pollution Prevention and

Control Licensing

IPPC Licence Review Application Form

This document does not purport to be and should not be considered a legal interpretation of the provisions and

requirements of the EPA Acts 1992 and 2003.

Environmental Protection Agency P.O. Box 3000, Johnstown Castle Estate, Co. Wexford

Telephone : 053-9160 600 Fax : 053-9160 699

EPA Reg. No: (Office use only)

For

insp

ectio

n pur

pose

s only

.

Conse

nt of

copy

right

owne

r req

uired

for a

ny ot

her u

se.

EPA Export 25-07-2013:20:16:19

IPPC Licence Review Application Form

Contents

Environmental Protection Agency

Application for a Review of an Integrated Pollution Prevention and Control Licence

Environmental Protection Agency Acts, 1992 and 2003.

CONTENTS

INTRODUCTION 3

SECTION A NON-TECHNICAL SUMMARY 5

NON-TECHNICAL SUMMARY 6

SECTION B GENERAL 19

SECTION C APPROVED ADJUSTMENTS 26

SECTION D EMISSIONS AND ENVIRONMENTAL IMPACT 27

SECTION E CONTROL AND MONITORING 48

SECTION F ACCIDENT PREVENTION & EMERGENCY RESPONSE 52

SECTION G RESOURCE USE & ENERGY EFFICIENCY 58

SECTION H REMEDIATION, DECOMMISSIONING, RESTORATION & AFTERCARE 62

SECTION I STATUTORY REQUIREMENTS 63

SECTION J DECLARATION 72

For

insp

ectio

n pur

pose

s only

.

Conse

nt of

copy

right

owne

r req

uired

for a

ny ot

her u

se.

EPA Export 25-07-2013:20:16:19

3

INTRODUCTION

The Protection of the Environment Act 2003 (POE Act) has transposed the Integrated Pollution Prevention and Control (IPPC) Directive (96/61/EC) into national legislation. This IPPC licence review application form enables the applicant to show compliance with the statutory requirements as set out in the IPPC Directive and the POE Act and any regulations made thereunder. Article 3 of the IPPC Directive (96/61/EC) specifies that the Agency shall ensure that installations are operated in accordance with basic obligations. This application form requires applicants to describe measures in place to ensure compliance with these basic obligations including use of best available techniques (BAT), energy efficiency and waste minimisation as set out in Article 6 of the IPPC Directive. Furthermore the applicant is required to submit information to show compliance with the requirement of the Fit and Proper Person provisions in accordance with Section 84(4) of the EPA Act as amended. Each page of the application form must be numbered, e.g. page 5 of 45, etc. The basic information should for the most part be supplied in the spaces given in application form and any supporting documentation should be supplied as attachments, as specified. While all sections in the application form may not be relevant to the activity concerned, the applicant should look carefully through all aspects of the form and provide the required information, in the greatest possible detail. All maps/drawings/plans must be no larger than A3 size and scaled appropriately such that they are clearly legible. In exceptional circumstances, where A3 is considered inadequate, a larger size may be requested by the Agency. Information supplied in this application, including supporting documentation will be put on public display and open to inspection and copying by any person at Agency headquarters and on its website. Should the applicant consider certain information to be confidential, this information should be submitted in a separate enclosure bearing the legend, “ In the event that this information is deemed not to be held as confidential, it must be returned to ........”. When submitting such information you should outline clearly the nature of information. The reasons why the information is considered confidential (with reference to the “Access to Information on the Environment” Regulations of 1993) should be stated in the Application Form, where relevant.

For

insp

ectio

n pur

pose

s only

.

Conse

nt of

copy

right

owne

r req

uired

for a

ny ot

her u

se.

EPA Export 25-07-2013:20:16:19

4

IPPC Review Application – Introduction

SmithKline Beecham (Cork) Ltd. (GSK) is applying for an IPPC Licence under Section 90 (1) of the Environmental Protection Agency Acts 1992 and 2003. The EPA has requested a review of the Licence to bring site operations into compliance with the requirements of the IPPC Directive 96/61/EC1. I. Legal Entity versus Company/Business Name

Whilst the Review Applicant’s name in the application is the name of the legal entity, i.e. SmithKline Beecham (Cork) Ltd., the trading/business name of the company is GlaxoSmithKline Cork.

Throughout the rest of the application the trading company name will be used, i.e. GlaxoSmithKline (GSK), to allow for consistency with site procedures, policies, etc.

II. GSK IPC Licence History and EPA Licence Register Re-numbering System

In July 2006, the EPA revised the licence numbering system used with regards to IPC Licence numbering.

GSK IPC Licensing History:

Old IPC Licence Ref. Numbers EPA Revised Numbering System

IPC Licence 04 IPC Licence P0004-01

IPC Licence 473 IPC Licence P0004-02

IPPC Licence Review Application Ref. No. P0004-03 (this document)

IPPC Licence Application Ref. No. P0004-03

Consequently the existing IPC Licence Ref. No. 473 will be referred to as P0004-02 throughout this Review Application.

1 Implemented into National Law via the Protection of the Environment Act 2003 (POE Act)

For

insp

ectio

n pur

pose

s only

.

Conse

nt of

copy

right

owne

r req

uired

for a

ny ot

her u

se.

EPA Export 25-07-2013:20:16:19

5

SECTION A NON-TECHNICAL SUMMARY

Non-Technical Summary of IPPC Licence Application A non-technical summary of the application is to be included here. The summary should identify all environmental impacts of significance associated with the carrying on of the activity/activities, and describe mitigation measures proposed or existing to address these impacts. This description should also indicate the normal operating hours and days per week of the activity. The following information should be included in the non-technical summary: A description of: − the installation and its activities, − the raw and auxiliary materials, other substances and the energy used in or

generated by the installation, − the sources of emissions from the installation, − the conditions of the site of the installation, − the nature and quantities of foreseeable emissions from the installation into each

medium as well as identification of significant effects of the emissions on the environment,

− the proposed technology and other techniques for preventing or, where this not possible, reducing emissions from the installation,

− where necessary, measures for the prevention and recovery of waste generated by the installation,

− further measures planned to comply with the general principles of the basic obligations of the operator, i.e.,

(a) all the appropriate preventive measures are taken against pollution, in

particular through the application of best available techniques (BAT); (b) no significant pollution is caused; (c) waste production is avoided in accordance with Council Directive

75/442/EEC of 15 July 1975 on waste; where waste is produced, it is recovered or, where that is technically and economically impracticable, it is disposed of while avoiding or reducing any impact on the environment;

(d) energy is used efficiently; (e) the necessary measures are taken to prevent accidents and limit their

consequences; (f) the necessary measures are taken upon definitive cessation of activities to

avoid any pollution risk and return the site of operation to a satisfactory state. − measures planned to monitor emissions into the environment. Supporting information should form Attachment No A.1

For

insp

ectio

n pur

pose

s only

.

Conse

nt of

copy

right

owne

r req

uired

for a

ny ot

her u

se.

EPA Export 25-07-2013:20:16:19

6

Non-Technical Summary A.1.1 Introduction This is a summary, in non-technical language, of both the information provided in the IPPC Licence Review Application and an overall summary of activities on-site. It is presented under the headings as outlined in the previous page. SmithKline Beecham (Cork) Ltd. (GSK) are applying for an IPPC Licence under Section 90 (1) of the Environmental Protection Agency Acts 1992 and 2003. The EPA has requested a review of the Licence to bring site operations into compliance with the requirements of the IPPC Directive 96/61/EC1. The primary objective of this “IPPC Licence Review Application Form” is to describe the measures that are in place on-site to ensure compliance with the basic requirements of Articles 3 & 6 of the IPPC Directive i.e. to ensure:

• The use of best available techniques (BAT) (Section D.6) • No significant pollution is caused (Sections D & E) • Energy is used efficiently (Section G) • Waste minimisation and management in accordance with Directive 75/442/EEC

(Section D.6) • Necessary measures are taken to prevent accidents and limit their

consequences (Section F) • Necessary measures are taken upon definitive cessation of activities (Section

H) and • The requirements of the Fit and Proper Person provisions are met (Section I)

In addition to fulfilling the legal requirements, there are three proposed extensions for the future development of the site which GSK would like to incorporate into the IPPC Licence. These proposed developments are discussed in Section A.6 below. A.2 A description of the installation and its activities GSK is a research based global healthcare company with over 100,000 employees worldwide and in excess of 100 operating sites. GSK is located at National Grid Reference E 178300 N 062700 on the southern shores of lower Cork Harbour, near the village of Ringaskiddy. GSK occupies a 52 acre site in Currabinny, approximately 21km from Cork city and 6.4 km from Carrigaline on the Currabinny road. (Refer to Drawing NTS 1). GSK is part of the GlaxoSmithKline Corporation and employs 544 permanent personnel on site. The original plant was developed between 1973 and 1975. Since the plant began operations in 1975, increased production has led to a number of expansions and modifications of production and ancillary facilities. However, throughout these changes attention has been paid to ensuring that the plant and its operations have had minimal impact on the environment. (Refer to Figure NTS 2 for Site Layout showing existing and proposed development areas).

1 Implemented into National Law via the Protection of the Environment Act 2003 (POE Act)

For

insp

ectio

n pur

pose

s only

.

Conse

nt of

copy

right

owne

r req

uired

for a

ny ot

her u

se.

EPA Export 25-07-2013:20:16:19

7

Features of interest or sensitive locations in the immediate vicinity include the wildlife lagoon inside the approach causeway to GSK. The surrounding marsh is home to many animals and birds, a high tide roost for waders and wildfowl and acts as an important staging post during the annual migration of many water species. GSK in conjunction with the Irish Wildbird Conservancy (IWC) play a significant role in maintaining this wildlife sanctuary. GSK Currabinny was granted an Integrated Pollution Control (IPC) Licence Reg. No. P0004-01 on the 6th of December 1994. Due to new developments on-site, GSK was subsequently granted a revised IPC Licence Reg. No. P0004-02 on 20th August 1999. Since 1999 there have been various modifications to the site and these adjustments are detailed in Section C of this Application Form. The site comprises of:

• 5 production buildings (buildings 101,120, 6001, 7001 and 35), • a milling/nanomilling facility (building 4001), • a research and development building, (building 7002 & 7003 (sub units 7601,

7701, 7801 & 7901)) • 2 warehouses (raw materials, intermediates, finished goods and maintenance

supplies), • external material storage areas including tank farms (waste and raw materials), • an environmental control centre, • a waste management facility (solid waste), • service utilities, • laboratories, • an engineering building, • office buildings, • a cafeteria and • a security building,

Pollution control equipment on-site includes;

• two high temperature incinerators (both incorporating a DeNOx unit) (unrecoverable solvents and waste gases),

• thermal oxidiser, • wastewater treatment plant (biotreatment/chemical treatment) and • three solvent recovery plants. • Firewater retention ponds

Figure NTS 3 illustrates the main buildings and locations of the pollution abatement equipment on-site. The facility produces bulk active pharmaceutical for clinical supplies and final products. Goods are exported to other GSK locations worldwide for formulation and distribution. The facility operates 24 hours per day for 7 days per week. Approximately, 1,045 tonnes of product (active pharmaceutical ingredient) was produced during the reporting period 2005. For information on the environmental performance of the site during 2005 please refer to the AER 2005 submitted to the EPA on 31st March 2006. The products are manufactured by multistage organic synthesis using batch processing operations. Each product is generated through a series of intermediate stages with each stage comprising a number of unit operations. A typical production process is outlined in Figure NTS 4.

For

insp

ectio

n pur

pose

s only

.

Conse

nt of

copy

right

owne

r req

uired

for a

ny ot

her u

se.

EPA Export 25-07-2013:20:16:19

8

Figure NTS 4: General Production Schematic The main unit operations carried out on site include the above production operations, as well as solvent recovery, utilities generation and pollution abatement.

The facility manufactures a range of products including:

GSK Products Details Seroxat / Paxil Based on Paroxetine which is an antidepressant Hycamtim Based on Topotecan which is an anti cancer therapeutic Kredex / Coreg Based on Carvedilol which is an anti hypertensive and a Congestive

Heart Failure therapy Requip Based on Ropinirole which is an anti Parkinsons’s agent Avandia Based on Rosiglitazone which is used in the treatment of Type 2

Diabetes Abacavir This compound is part of treatment for HIV. Lapatinib Used in treatment of cancerous tumours.

This is a product which is being scaled up from R+D to the main plants on site.

Dutasteride Treatment of Benign Prostatic Hyperplasia Lacidipine Used in treatment of Hypertension

A.3 Raw and auxiliary materials, other substances and the energy used in or

generated by the installation A.3.1 Raw and auxiliary materials and other substances Substances used in the manufacture of product on-site include:

• Raw materials, intermediates and reagents (organic and inorganic compounds); • Solvents; • Catalysts; and • Filter aids.

Raw materials (reagents) and intermediates

Reactor vessel (suitable temperature

and pressure)

+ solvent Crystallisation (under cold

temperature)

Centrifuge/

Pressure Filter

Dryer

Milling Product

(bagging/drumming for further processing)

Product crystals

For

insp

ectio

n pur

pose

s only

.

Conse

nt of

copy

right

owne

r req

uired

for a

ny ot

her u

se.

EPA Export 25-07-2013:20:16:20

9

Other chemicals used on site include: • Cleaning solutions; • Bench top quantities of laboratory reagents; • Lubricants for utility equipment; • Wastewater treatment plant dosing chemicals; • Water treatment chemicals; • Fuels; and • Refrigerants.

Materials generated by the activity include: o Active pharmaceutical ingredients and their intermediates; o Process-related hazardous and non-hazardous wastes; o Effluent; and o Sludge.

A.3.2 Wastes generated by the installation Raw materials are subject to various physical and chemical changes in order to produce the required chemical in the correct form. As a result solid, liquid and gaseous emissions are generated. These emissions are subjected to physical and chemical treatment to remove any toxic, odorous or environmentally sensitive substances in accordance with IPPC Directive 96/61/EC prior to discharge from the facility. A large percentage of the non-recoverable solvents and certain aqueous solutions as well as gaseous emissions are treated / destroyed in the two incinerators and thermal oxidiser on site. A range of non-hazardous wastes are generated on site, including:

• Construction and Demolition Wastes • WWTP sludge • Glass • Canteen waste • Packaging waste • Office waste • General non-hazardous waste for recycling (e.g. wooden pallets, scrap metal,

etc.) • General waste for landfill • Empty containers.

Hazardous wastes generated on site include: • Solvents, recovered on and off site • Solvents, incinerated on and off site and used for heat recovery off site • Effluent, treated in site wastewater treatment plant • Laboratory Wastes • Off-spec Raw Materials • Catalysts and metals, recovered off site • Miscellaneous (minor sources), including UV and Fluorescent tubes, waste oils,

batteries, unused paints, oily rags, etc. The breakdown of the wastes generated, tonnages and associated recovery and disposal methods is given each year in the Annual Environmental Report. In 2005, 2,470 Tonnes of non-hazardous waste was generated on-site, of which 1,936 Tonnes (78%) was recovered. In 2005, 25,101 Tonnes of hazardous waste was generated on

For

insp

ectio

n pur

pose

s only

.

Conse

nt of

copy

right

owne

r req

uired

for a

ny ot

her u

se.

EPA Export 25-07-2013:20:16:20

10

site, of which 7,069 Tonnes (28%) was recovered, 58% of the 7,069 T was recovered on site. GSK ensures that the on- and off-site management of waste produced by the facility is carried out in accordance with all relevant statutory requirements. GSK implements a programme of audits of waste management facilities as part of its Environmental Management Programme. In March 2005, GSK assigned an external contractor to oversee the management of hazardous and non hazardous waste within the facility and the shipments of waste off-site. This Total Waste Management (TWM) approach has led to a reduction in the volume of waste going for disposal. A.3.3 Energy used or generated by the installation Energy usage on site comprises mainly of electricity and natural gas, with some diesel for energy back-up and a very small quantity of liquefied petroleum gas used for forklift trucks. Electricity is used to power all drives, ventilation, lighting systems, alarm and security systems, computer systems, instrumentation and sundry appliances. Natural gas is burned to generate steam and hot water and to operate the thermal oxidiser and the two incinerators. One incinerator is fitted with a waste heat boiler to raise steam. There are two additional gas boilers on site to generate steam. Diesel is used as a backup fuel supply for the two boilers and to power the two standby fire pumps. The usage of energy on site breaks down as follows: electricity 52%; natural gas 46%; diesel 2%; liquefied petroleum gas negligible. The total energy usage in 2005 was 104 GWh (375,000 GJ). A.4 Sources of emissions from the installation A.4.1 Atmospheric Emissions The main emissions to atmosphere from GSK are from the three incinerators and the thermal oxidiser. The emissions consist of by-products of combustion: nitrogen oxides, carbon monoxide, particulates, and negligible sulphur dioxide. There are also 35 existing vents and 9 proposed vents (the details of which are included in this Review Application, Section D and Attachment D) from pharmaceutical dust handling activities such as powder charging, discharge from filters and dryers, and from milling and size reduction operations. Minor emissions to atmosphere with little environmental significance arise from the following:

• Emergency generators (diesel-powered); • Volatile organic compound vapours from laboratories; • Cooling towers; • Designated local extract fans; • Utility-related vents; • Firewater pump (diesel-powered); • Boilers;

For

insp

ectio

n pur

pose

s only

.

Conse

nt of

copy

right

owne

r req

uired

for a

ny ot

her u

se.

EPA Export 25-07-2013:20:16:20

11

• Ventilation systems. In addition, there may be small losses via pressure relief vents or of refrigerant from the chillers. Fugitive emissions are minimised through process technology. The most significant potential emission points from the facility include the incinerator bypass scrubber stack A4-3B and the thermal oxidiser bypass stack A4-15A. New potential emission points associated with the proposed extensions include bursting discs on reactor vessels and filter dryers and pressure relief valves on new heat exchangers. The primary source of odour from the facility in the past was Methyl Mercaptan, used in the production of Cimetidine. Since this process ceased on site in 2006, there have been no issues regarding odour. A.4.2 Water and Effluent

Foul effluent from the facility and process effluent from each of the main buildings (Manufacturing, Utilities, Warehouse, Laboratories, R & D Buildings) is treated in the on-site wastewater treatment plant. The treated combined effluent is discharged to Cork Harbour at Lough Beg.

Surface water run-off from the production areas is directed to the two retention ponds. The run-off is monitored on-line before entry to the retention pond. Under normal conditions, clean surface water flows through the pond to the outfall pipe. Surface water run-off from the car park areas is collected separately and passes through hydrocarbon interceptors before combining in the outfall pipe with the surface water run-off from the production areas. The combined run-off discharges into Cork Harbour at Lough Beg. In the event of contamination of the surface water which is detected by an inline TOC and pH meter, the surface water is immediately directed to the surface water retention ponds by the shutting of automatic penstock valves. A.4.3 Soil and Groundwater

There are no emissions to soil or groundwater from the facility.

A.4.4 Noise

The principal noise sources from the facility include:

• Dust extract units • Circulation pumps • Nitrogen plant • Cooling tower pumps • Incinerator gas fans • Wastewater treatment plant • Cooling tower • General extraction fans.

For

insp

ectio

n pur

pose

s only

.

Conse

nt of

copy

right

owne

r req

uired

for a

ny ot

her u

se.

EPA Export 25-07-2013:20:16:20

12

There are also miscellaneous noise sources such as site traffic, gas and liquid bulk filling, site alarms, valves venting, malfunctioning equipment. There have been no developments on-site since 1998 which have led to a change in source, location or nature of noise emissions from the site. A.5 Conditions of the site of the installation

The existing environmental condition of the site was assessed in detail as part of the Environmental Impact Assessment process for IPC Licence Application P0004-02. A copy of the complete Environmental Impact Statement was included with the IPC Application as submitted to the EPA in August 1999.

Since then under the various requirements of IPC Licence No. P0004-02, GSK conduct a schedule of monitoring and reporting to the EPA. A summary of the monitoring and reporting is submitted to the EPA on the 31st of March each year. The most recent summary of conditions at the GSK site was submitted to the EPA on the 31st of March 2006 in the 2005 AER.

A.5.1 Air Quality & Climate Emissions to atmosphere are monitored routinely as per the requirements of the IPC Licence. In 2005, the emissions to atmosphere across the site were more than 99.99% compliant with these conditions for all parameters. Annual monitoring of active pharmaceutical ingredient (API) particulates from vents showed emissions to be well within the licensed limits. A.5.2 Water and Effluent Emissions of surface water to Lough Beg are monitored continuously for total organic carbon and pH and diverted to retention ponds for appropriate treatment when outside of licensed limits. In 2005, discharges of surface water were 100% compliant with the IPC licence. Process and foul effluent from the site are treated in the site’s wastewater treatment plant prior to discharge to Cork Harbour at Lough Beg. The discharge is monitored continuously for flow rate and pH. In 2005, discharges of treated effluent were 100% compliant with the IPC licence. A.5.3 Soil and Groundwater In accordance with IPC Licence P0004-02, the ten on-site groundwater wells are sampled and analysed on a bi-annual basis. The results have demonstrated that there is generally a low level of contamination in these wells. At present abstraction and treatment of groundwater from monitoring wells MW-2S and MW-5S is taking place to improve the quality of groundwater within these wells. A.5.4 Noise An annual noise survey was undertaken at the site during November 2005; measurements were taken at the nearest noise-sensitive locations and site boundary locations. The noise levels recorded at noise-sensitive locations were within the IPC limits during both daytime and night-time.

For

insp

ectio

n pur

pose

s only

.

Conse

nt of

copy

right

owne

r req

uired

for a

ny ot

her u

se.

EPA Export 25-07-2013:20:16:20

13

A.6 Nature and quantities of foreseeable emissions from the installation into each medium as well as identification of significant effects of the emissions on the environment

The proposed site development projects include:

• An extension to the existing Building 35 (Phase 2) for the production of Lapatinib 4. The extension will include the installation of one 12,000 L hastelloy reactor, one 16,000 L glass lined reactor and two 6 m2 filter dryers (2008). Drawing No. 3221/09/1185 as included in Attachment B.5 shows the location of the proposed extension adjacent to the existing Building 35 Phase I. All organic vapours from the Lapatinib 4 process will be tied into the lean gas header and routed to the existing incinerators.

• Use of Area 9/29 in Building 101 to deliver 80 tonnes of Lapatinib 3 This change of use will not result in any environmental impact. Drawing No. 3221/09/1185, Attachment B.5 shows the location of the expansion within Building 101.

• Expansion of Area 79 in Building 7003 to expand capacity for Dutasteride.

Drawing No. 3221/09/1185, Attachment B.5 shows the location of the expansion within Building 7003.

• New Utilities Building.

A.6.1 Atmospheric Emissions The proposed extensions will result in the inclusion of 9 additional main point source emissions to atmosphere. The nature of the emissions from the vents is active pharmaceutical dust (API). These small diameter vents are HEPA filtered to ensure 99.9% removal efficiency and will be monitored in accordance with IPPC Licence requirements. Consequently these vents will have no significant adverse impact on the ambient air quality. A.6.2 Water and Effluent There has been no change in the nature or quantity of emissions to surface water from that detailed in the IPC Review Application submitted in 1998. GSK are however seeking to change some of the existing Licence parameters associated with WWTP emission point SW01, as a result of the proposed extensions and the proposed addition of a third surface water retention pond. The proposed changes include:

• Increase in the maximum volume to be emitted from process effluent diffuser (SW01) in any one day from 1000 m3/day to 1,300 m3/day.

• Corresponding increase in the maximum rate per hour emission from 250 m3/hr to 325 m3/hr.

These proposed changes will have a negligible negative impact on Loughbeg. In addition to the above proposed changes, GSK are seeking:

• Reduction in the current Licence Limit for COD from 2,400 mg/L to 2,000 mg/L in line with GSK’s programme of continuous improvement.

For

insp

ectio

n pur

pose

s only

.

Conse

nt of

copy

right

owne

r req

uired

for a

ny ot

her u

se.

EPA Export 25-07-2013:20:16:20

14

A.6.3 Soil and Groundwater There will be no emissions to soil or groundwater from the site as a result of future developments. A.6.4 Noise There is no impact on noise levels at noise sensitive locations as a result of the proposed extensions. Section A.4.5 discusses the noise emission from the existing facility.

A.7 Proposed technology and other techniques for preventing or, where this not possible, reducing emissions from the installation

All existing technologies for preventing and reducing emissions from the installation have been included in IPC Application No. P0004-02 and in subsequent “Approved Adjustments” as discussed in Section C of this IPPC Licence Review Application. There are currently no additional technologies being installed on site with the exception of the new multipurpose hydrogen chloride scrubber to treat hydrogen chloride and acetic acid emissions from a no. of processes on-site. BAT control technologies on-site are discussed in detail in Section D.6 and Attachment D.6. A.8 Where necessary, measures for the prevention and recovery of waste

generated by the installation Exiting measures for the prevention and recovery of waste generated by the installation are detailed in IPC Licence Application No. P0004-02 and in subsequent “Approved Adjustments” as discussed in Section C of this IPPC LIcence Review Application.

Manufacturing and associated activities at the GSK facility will unavoidably generate waste. As part of the GSK group of companies, GSK Worldwide operates and maintains a well-developed waste management, minimisation and auditing strategy which is in place at the GSK Currabinny site.

Wastes from the proposed extensions will be managed in accordance with site procedures and under the remit of the TWM system. It is not anticipated that these extensions with contribute significantly to the waste volumes generated on-site.

A.9 Further measures planned to comply with the general principles of the

basic obligations of the operator i.e. A.9.1 Preventive Measures and Best Available Techniques; BREF (BAT Reference Documents) applicable to GSK include:

� BREF document on the General Principles of Monitoring � BREF in Common Waste Water and Waste Gas Treatment /Management

Systems in the Chemical Sector � BREF on Emissions from Storage � BREF on the Manufacture of Organic Fine Chemicals � BREF for Waste Incineration.

For

insp

ectio

n pur

pose

s only

.

Conse

nt of

copy

right

owne

r req

uired

for a

ny ot

her u

se.

EPA Export 25-07-2013:20:16:20

15

There is a high level of Environmental Protection on-site. GSK has shown during the life span of the current and previous IPC Licenses that emissions from the facility do not cause any significant environmental pollution. The BAT measures in place on-site ensure that the site has reduced to a minimum the overall impact of emission on the environment and the associated risks to it.

A.9.2 No significant pollution is caused; Sections B to J of the IPPC Licence Review Application demonstrate that the operation of the facility does not cause significant environmental pollution. The AER’s as submitted to the EPA on an annual basis provide further evidence of GSK’s environmental compliance record. A.9.3 Waste production is avoided in accordance with Council Directive

75/442/EEC of 15 July 1975 on waste; where waste is produced, it is recovered or, where that is technically and economically impossible, it is disposed of while avoiding or reducing any impact on the environment;

The operation of the facility results in the generation of a range of hazardous and non-hazardous waste. Wastes produced on site are segregated at source.

Under the IP(P)C licensing system the facility is subject to a number of principles and conditions including Best Available Techniques (BAT), the IPPC licence waste conditions themselves, and the requirement to establish and maintain an Environmental Management System (EMS) and Environmental Management Programme (EMP). All of these conditions in addition to the Total Waste Management (TWM) system on-site ensure that waste is managed in an environmentally responsible and proactive manner.

A.9.4 Energy Efficiency GSK subscribes to a policy of energy management, which is to

• Maximise the energy efficiency of all operations; • Reduce energy consumption and costs; • Meet GSK Corporate targets for energy consumption reduction.

The site underwent an Energy Audit in 2002. This identified a number of areas where improvements in energy efficiency could be made. A number of measures to improve energy efficiency have been implemented on site and more are planned for the period to end of 2007. To ensure that energy is effectively managed on the site, a site Energy Manager was appointed in 2002. The site was issued with a Greenhouse Gas Permit by the EPA (IE GHG 095-02). This places obligations on the site for the reduction of carbon dioxide emissions, through both a reduction of generation of carbon dioxide on site and reduction in the uses of energy resources that generate carbon dioxide, e.g. electricity from coal-powered stations. The site is signed up to the EU Emissions Trading Scheme. A.9.5 Accident Prevention and Emergency Response GSK’s philosophy is based upon accident prevention, coupled with appropriate emergency response to deal effectively with an accident or emergency situation, both during and outside of normal working hours. Safety and Environmental training, incident and accident investigation and corrective action follow-through, safe systems of work and safe working environment are the fundamentals of this prevention

For

insp

ectio

n pur

pose

s only

.

Conse

nt of

copy

right

owne

r req

uired

for a

ny ot

her u

se.

EPA Export 25-07-2013:20:16:20

16

approach documented in GSK’s Health and Safety and Environmental Policies and Manuals. Furthermore, the activity is obliged to comply with the requirements of the GSK Global EHS Standard 307, Business Continuity Planning, in the event of major fires or catastrophic events. A.9.6 Decommissioning A Residuals Management Plan (RMP) will be prepared to address the remediation, decommissioning, restoration and aftercare of the facility. The RMP will be based on the EPA’s Guidance on Environmental Liability Risk Assessment, Residuals Management Plans and Financial Provision (2006).� In addition, as part of GSK’s Global EHS Standard 308, Business, Product and Property Transactions, it is GSK’s responsibility to minimise the environmental, health and safety risks and associated liabilities when acquiring or divesting property, including after cessation of activities. Any divestiture of the facility will be preceded by an environmental due diligence audit to assess and quantify potential environmental liabilities associated with the transaction. A.10 Measures Planned to Monitor Emissions into the Environment A.10.1 Monitoring Emissions to Atmosphere Under the current IPC Licence (P0004-02) all main emissions to atmosphere are monitored in accordance with Schedule 1(iii). It is proposed that the existing and new main dust emissions to atmosphere are monitored every two years going forward instead of the current annual requirement. Further details are discussed in Section E of the Review Application.

A.10.2 Monitoring Emissions to Surface Water There are no new emissions to surface water, however GSK are requesting to change the monitoring frequencies required by the existing IPC Licence on SW01. The proposed changes are as follows:

• Nutrient balance; to reduce the monitoring frequency from twice weekly to once weekly.

• TOC; to eliminate the requirement for TOC testing. • BOD; to reduce the monitoring frequency from once weekly to once per month. • Organic solvents; to reduce the monitoring frequency from four times per year to

two times per year. • Copper; to reduce the monitoring frequency from once per month to once per

quarter. • Zinc; to reduce the monitoring frequency from once per month to once per quarter.

Justifications for the above requests are detailed in Section E.2.2. A.10.3 Monitoring Emissions of Effluent to Sewer There are no emissions to sewer from the site.

For

insp

ectio

n pur

pose

s only

.

Conse

nt of

copy

right

owne

r req

uired

for a

ny ot

her u

se.

EPA Export 25-07-2013:20:16:20

17

A.10.4 Waste management TWM with the aid of a web based database tracks the movement of all hazardous and non hazardous waste on and off site. A.10.5 Noise It is not proposed to alter the noise monitoring schedule as per IPC Licence No. P0004-02.

A.10.6 Energy and water consumption Electricity consumption

The electricity delivered to the site is metered by GSK at the site substation. The electricity is converted from 20Kv electricity to 415v electricity for use throughout the site distribution system. The electricity distributed throughout the site is metered at each of the main production areas. The main electricity users on site are Utilities, HVAC, and other production areas.

Natural gas consumption

The natural gas delivered to the site is metered by GSK. The main use for gas on site is as a support fuel for the two site incinerators, one of which has a waste heat boiler (WHB) that produces steam, and for two boilers that produce steam, used in the production areas of the site. The only other use of gas on site is as a fuel for the canteen cooking ovens and as a fuel for the standby thermal oxidiser (on permanent standby since 2004).

Steam consumption

The boilers burn gas to boil process water to raise steam. They operate with a thermal efficiency of between 80 and 90 % efficiency throughout the year. The waste heat boiler on incinerator no. 3 provides approximately 70% of the site’s steam demand. The main steam users are the HVAC system and the multipurpose Solvent Recovery plant.

Diesel oil consumption

Diesel oil is used on site as a standby fuel for the boilers in the event of interruption to the natural gas supply to the site. In addition to this routine use, a small quantity (1%) is used in the standby diesel fire pumps. A small quantity of diesel is used to power the forklifts and site vehicles.

Specific energy consumption

The specific energy consumption of the site has been calculated for the site’s Sustainable Energy Ireland (SEI) Large Industries Energy Network (LIEN) scheme. This has shown a general downward trend over the last ten years, with a reduction of 8.97% in energy usage in 2005 from the 2004 level.

Water consumption

Mains water metered annual usage is in the order of 475,000 m3.

For

insp

ectio

n pur

pose

s only

.

Conse

nt of

copy

right

owne

r req

uired

for a

ny ot

her u

se.

EPA Export 25-07-2013:20:16:20

18

A.10.7 Environmental incidents and complaints

All non-compliances with the conditions of the IP(P)C Licence are notified to the Agency, investigated, rectified and measures put in place to minimise the potential for recurrence. All complaints are notified to the Agency. They are investigated to determine whether they are attributable to GSK; if so, mitigatory measures are taken to rectify the cause of the complaint and minimise the potential for recurrence. All non-compliances and complaints are reported each year in the Annual Environmental Report. In 2005, the only complaints received related to odour (5 No.) and noise levels (1 No.). It is anticipated that the cessation of Cimetidine production in early 2006 will result in a reduction of odour complaints in the future.

For

insp

ectio

n pur

pose

s only

.

Conse

nt of

copy

right

owne

r req

uired

for a

ny ot

her u

se.

EPA Export 25-07-2013:20:16:20

For

insp

ectio

n pur

pose

s only

.

Conse

nt of

copy

right

owne

r req

uired

for a

ny ot

her u

se.

EPA Export 25-07-2013:20:16:20

For

insp

ectio

n pur

pose

s only

.

Conse

nt of

copy

right

owne

r req

uired

for a

ny ot

her u

se.

EPA Export 25-07-2013:20:16:20

For

insp

ectio

n pur

pose

s only

.

Conse

nt of

copy

right

owne

r req

uired

for a

ny ot

her u

se.

EPA Export 25-07-2013:20:16:20

19

SECTION B GENERAL B.1. Owner/Operator * Review Applicants Name: Smithkline Beecham (Cork) Limited

Address: Currabinny Carrigaline Co.Cork Telephone No: 021-4378800 Fax No: 021-4378560 e-mail : john.g.kelleher@gsk.com * This should be the name of the review applicant on the date the Review Application is

lodged with the Agency. This should be the name of the legal entity (which can be a limited company or a sole trader). A trading/business name is not acceptable.

Address for correspondence : As above (if different from above) Address of Body Corporate : GlaxoSmithKline

980 Great West Road

Brentford

Middlesex

TW8 9GS

UK

Contact e-mail address : russell.b.thompson@gsk.com

For

insp

ectio

n pur

pose

s only

.

Conse

nt of

copy

right

owne

r req

uired

for a

ny ot

her u

se.

EPA Export 25-07-2013:20:16:20

20

Confirm whether the information submitted in relation to the legal entity of the company has changed from that detailed in the original application or in the most recent review application.

Has information in relation to legal entity of the company changed?

Yes No

If yes, supply the following information: (a) Certified Copy of Certificate of Incorporation (b) Company’s Number in Company’s Registration Office and (c) Particulars of Registered Office of the Company. Supporting information should form Attachment No B.1.

Answer

Whilst there has been no change to the legal entity of the company since the previous IPC Licence Application submitted in 1998. A copy of the Certificate of Incorporation and the information requested in (b) and (c) above have been included in Attachment B.1 for clarity purposes. In past correspondence to and from the EPA, both SmithKline Beecham (Cork) Ltd. and SmithKline Beecham (Manufacturing) Ltd. have been used. SmithKline Beecham (Cork) Ltd. should be used in all correspondence in relation to the IPPC Licence going forward. Name and address of the proprietor(s) of the Land on which the Activity is situated (if different from review applicant named above). Proprietor’s Name: As above Address: Name and address of the owner(s) of the building and ancillary plant in which the activity is situated (if different from review applicant named above). Name: As above Address:

For

insp

ectio

n pur

pose

s only

.

Conse

nt of

copy

right

owne

r req

uired

for a

ny ot

her u

se.

EPA Export 25-07-2013:20:16:20

21

B.2. Location of Activity Company Name: Smithkline Beecham (Cork) Limited Full Address: Currabinny Carrigaline Co.Cork Telephone No: 021-4378800 Fax No: 021-4378560 Contact Name(s): Ian Mc Auliffe

John Kelleher

Position(s): Environmental Regulatory Group Leader___

Environmental, Health and Safety Manager

Contact e-mail: ian.m.mcauliffe@gsk.com John.G.Kelleher@gsk.com Irish National Grid Reference (12 digit-6E,6N) * 178300 E 062700 N * The Grid Reference should be supplied using GPS in Irish National Grid. Location maps (no larger than A3) with site boundary outlined in colour, a specified drawing number and grid references should be enclosed in Attachment No B.2.

For in

spec

tion p

urpo

ses o

nly.

Conse

nt of

copy

right

owne

r req

uired

for a

ny ot

her u

se.

EPA Export 25-07-2013:20:16:20

22

B.3. Class of Activity

1. Identify the relevant activity / activities in the First Schedule of the EPA Acts, 1992 and

2003 to which the activity relates:

Schedule No Class No. Description Note 1

1

5.16

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

1

11.1

The recovery or disposal of waste in a facility, within the meaning of the Act of 1996, which facility is connected or associated with another activity specified in this Schedule in respect of which a licence or revised licence under Part IV is in force or in respect of which a licence under the said Part is or will be required.

Note 1: In order to give a precise identification select only those words from the description of the class or classes that best describes the nature of the activity for which the licence is being applied for.

B.4. Employees

Give the number of employees and other persons working or engaged in connection with the activity on the date of submission of this application for a review and the number required during normal levels of operation.

Number of Employees (at the present): 540

Number of Employees (normally) : 540

For

insp

ectio

n pur

pose

s only

.

Conse

nt of

copy

right

owne

r req

uired

for a

ny ot

her u

se.

EPA Export 25-07-2013:20:16:20

23

B.5. Relevant Planning Authority Give the name of the planning authority in whose functional area the activity is carried out. Name: Cork County Council Address: The Planning Department Model Business Park Model Farm Road Telephone No: 021 4867006 Planning Permission for this project:-

Obtained � Applied for � Not applied for � Local Authority Planning File Reference No: N/A Attachment No B.5 should contain a schedule of all planning permissions in force at the time of this submission. Evidence should also be included in the attachment of a notification having been given to the relevant Planning Authority in accordance with the requirements of Section 87(1)(a) of the EPA Acts 1992 and 2003, as well as a copy of notice published in a newspaper (circulating in the district) of intention to apply for a review of licence.

For

insp

ectio

n pur

pose

s only

.

Conse

nt of

copy

right

owne

r req

uired

for a

ny ot

her u

se.

EPA Export 25-07-2013:20:16:20

24

B.6. Relevant Sanitary Authority. In the case of a discharge of any trade effluent or other matter to a piped sewer of a sanitary authority, give the name of the sanitary authority in which the sewer is vested or by which it is controlled. Name: Not applicable Address: Telephone No: In the case of a discharge of any trade effluent or other matter to a sewer not owned by or vested in a sanitary authority, the applicant must supply as Attachment No B.6 the names, addresses and telephone contact information for the owners or those responsible for:

a. The sewer or drain into which the trade effluent is discharged; b. The waste water treatment facility into which the sewer discharges; and c. The quality of the resultant treated effluent prior to discharge to waters.

For

insp

ectio

n pur

pose

s only

.

Conse

nt of

copy

right

owne

r req

uired

for a

ny ot

her u

se.

EPA Export 25-07-2013:20:16:20

25

B.7. Relevant Health Service Executive Region The applicant should indicate the Health Service Executive Region where the activity is located.

Name: Health Service Executive (HSE) - Southern Area

Address: Wilton Road

Cork.

_________________________________________

�������������������������������������������������������� Telephone No: 021-4545011

For

insp

ectio

n pur

pose

s only

.

Conse

nt of

copy

right

owne

r req

uired

for a

ny ot

her u

se.

EPA Export 25-07-2013:20:16:20

26

SECTION C APPROVED ADJUSTMENTS In the case where the Office of Environmental Enforcement (OEE) of the Agency has agreed any variations or adjustments to the conditions of the existing licence, the applicant must supply a schedule detailing these agreed variations and adjustments to the existing licence conditions. An updated, scaled drawing of the site layout (no larger than A3) providing visual information on such adjustments or variations where appropriate should be included. Attachment No C1 shall include the schedule of variations and/or adjustments together with the updated drawing.

Answer

A schedule detailing the agreed variations and adjustments to the existing licence conditions since 1999 is provided in Attachment C.1. The agreed variations and adjustments which are suitable for visual display on a drawing have already been included in other drawings in support of this review application. The schedule included in Attachment C.1 detailing the agreed variations specifies the appropriate reference drawing.

For

insp

ectio

n pur

pose

s only

.

Conse

nt of

copy

right

owne

r req

uired

for a

ny ot

her u

se.

EPA Export 25-07-2013:20:16:20

27

SECTION D EMISSIONS AND ENVIRONMENTAL IMPACT D.1. Emissions to Atmosphere Specify whether there has been a change in the quantity or nature of emission to atmosphere from that detailed in the original application or earlier review application(s) and/or specified in your existing licence:

Yes No If yes, provide further information as detailed below. D.1.A Point-source emissions to atmosphere Outline significant adjustments to the operations on site, if any, which has led to a change in the quantity or nature of emissions to atmosphere. A summary list of any revised emission points, together with maps/drawings (no larger than A3) and supporting documentation should be included as Attachment No D.1.A The applicant should address in particular any emission point where those substances listed in the Schedule to the Environmental Protection Agency (Licensing) (Amendment) Regulations, 2004 (S.I. No. 394 of 2004) are emitted. For emissions outside the BAT guidance level, a full evaluation of the existing abatement/treatment system must be provided. A planned programme of improvement towards meeting upgraded standards in advance of 30th September 2007 is required. This should highlight specific goals and a time scale, together with options for modification, upgrading or replacement as required to bring the emissions within the emission levels as set out in the BAT guidance note(s).

Answer

D.1.A Point-source emissions to atmosphere Details of all existing point source emissions to atmosphere were previously submitted to the EPA in the application for IPC Licence P0004-02 in 1998. There are no emissions outside the BAT guidance levels. Further discussion on BAT is provided in Section D.6. There have been some adjustments to the operations on site which have led to the addition of dust emission points and minor emissions points to atmosphere since the previous IPC Licence was issued in 1999, these alterations were notified to the EPA accordingly as outlined in Section C of this Application. The additional emission points are listed in Attachment D.1.A. In addition to the recent variations, there are three proposed projects for which Planning Permission has been approved. These projects will result in the addition of point source emissions to atmosphere.

For

insp

ectio

n pur

pose

s only

.

Conse

nt of

copy

right

owne

r req

uired

for a

ny ot

her u

se.

EPA Export 25-07-2013:20:16:21

28

The proposed projects include:

• An extension to the existing Building 35 (Phase 2) for the production of Lapatinib 4. The extension will include the installation of one 12,000 L hastelloy reactor, one 16,000 L glass lined reactor and two 6 m2 filter dryers (2008). Drawing No. 3221/09/1185 as included in Attachment B.5 shows the location of the proposed extension adjacent to the existing Building 35 Phase I. All organic vapours from the Lapatinib 4 process will be tied into the lean gas header and routed to the existing incinerators.

• Use of Area 9/29 in Building 101 to deliver 80 tonnes of Lapatinib 3 This change of use will not result in any environmental impact. Drawing No. 3221/09/1185, Attachment B.5 shows the location of the expansion within Building 101.

• Expansion of Area 79 in Building 7003 to expand capacity for Dutasteride.

Drawing No. 3221/09/1185, Attachment B.5 shows the location of the expansion within Building 7003.

• New Utilities Building.

Drawings in support of the extension to Building 35 and the Dutasteride expansion are included in Attachment D.1 for reference. D.1.A.1 Main Atmospheric Emission Points Attachment D.1.A provides a detailed list of the Main Emission Points to be included in the proposed IPPC Licence P0004-03 as per the following tables: Table D.1.1 Main Point Source Emission Vents to be Removed from IPPC Licence

P0004-03 Table D.1.2 Existing Main Point Source Emission Vents to be Included in IPPC Licence

P0004-03 Table D.1.3 Proposed New Main Point Source Emission Vents to be Included in IPPC

Licence P0004-03 Tables D.1.4 to D.1.12 EPA Tables – Main Emissions to Atmosphere Table D.1.13 EPA Table – Main Emissions to Atmosphere – Chemical Characteristics The existing main point source emissions to atmosphere from the facility include: A2-2 Incinerator No. 4 A2-1 Incinerator No. 1 A2-3A Incinerator No. 3A A2-15(i) Thermal Oxidiser 1 A2-15(ii) Thermal Oxidiser 1 V16 Thermal Oxidiser 2

For

insp

ectio

n pur

pose

s only

.

Conse

nt of

copy

right

owne

r req

uired

for a

ny ot

her u

se.

EPA Export 25-07-2013:20:16:21

29

In addition to these main emission points there are 27 existing vents from the pharmaceutical dust handling activities such as powder charging, discharge from filters and dryers, and from milling and size reduction unit operations. There are 9 new API vents associated with the proposed projects. The dusts generated from these activities are ducted away from the area by fan vacuum and the air stream containing the dust is trapped in a pre-filter followed by a HEPA filter. A list of existing and details of the new API dust vents are provided in Attachment D.1.A. Specific details on the existing vents were provided to the EPA in IPC Licence Review Application 1998 and subsequent supporting information and correspondence to the EPA. D.1.A.2 Minor Atmospheric Emission Points Details on existing minor atmospheric emission points are provided in:

- Table 12A (v) of IPC Licence Review Application 1998 and - Section 7, Pages 1 – 15, Extra Information Document (March 1999)

submitted in Support of the IPC Licence Review Application There are 4 new minor vents associated with proposed projects; details of these minor vents are provided Attachment D.1.A.

Attachment D.1.A provides a detailed list of the Minor Emission Points to be included in the proposed IPPC Licence P0004-03 as per the following tables: Table D.1.14 Existing Minor Point Source Emissions to Atmosphere Amended since 1999 Table D.1.15 Proposed New Minor Point Source Emission to Atmosphere to be

Included in IPPC Licence P0004-03 Table D.1.16 EPA Table – Minor Emissions to Atmosphere

For

insp

ectio

n pur

pose

s only

.

Conse

nt of

copy

right

owne

r req

uired

for a

ny ot

her u

se.

EPA Export 25-07-2013:20:16:21

30

The applicant should address in particular any emission point where the substances listed in the Schedule to the Environmental Protection Agency (Licensing) (Amendment) Regulations, 2004 (S.I. 394 of 2004) are emitted.

Answer D.1.A.3 Substances Listed in SI 394 of 2004 The substances listed in the Schedule to S.I. 394 are emitted from existing main emission points V1 and V3A, the details of which have been submitted in the IPC Licence Review Application 1998 and summarised in Annual Environmental Reports thereafter. A summary of the emissions from V1 and V3A in 2005 are presented in Table D.1.17. Table D.1.17 Summary of the Emissions for V1 and V3A in 2005

Compound V1 Avg. Conc. mg/M3

2005

V3A Avg. Conc. mg/M3

2005

IPC P0004-02 Limit

mg./Nm3

Comment

Sulphur Dioxide 0.63 3.82 200 30 minute avg.

Continuously monitored

Oxides of Nitrogen 0.69 97.75 400 30 minute avg.

Continuously monitored

Carbon Monoxide 2.34 2.16 100 60 minute avg.

Continuously monitored

Volatile Organic Compounds (TOC)

0.458 0.316 20 30 minute avg.

Continuously monitored

Dust 0.174 0.93 30 30 minute avg.

Continuously monitored

Chlorine compounds Hydrogen Chloride

0.37 0.118 60 30 minute avg.

Continuously monitored

Fluorine compounds Hydrogen Fluoride

0.263 0.15 4 30 minute avg.

Grab samples

Polychlorinated dibenzodioxins and polychlorinated dibenzofurans.

0.4 pg/m3 3.4 pg/m3 100 pg/m3 6 – 8 hour sample

Grab samples

As can be seen from the above table, all values are well below BAT limits and the limits specified in IPC Licence P0004-02. With regards to the emission points approved by the EPA since IPC Licence P004-02 was granted in 1999, the only substance listed in the Schedule of SI 394 of 2004 which is emitted from these emission points is API dust. These particulate vents are monitored on an annual basis as per the IPC Licence monitoring requirements. All results in 2005 were found to be below the emission limit value of 1 mg/m3 for total particulates and 0.15 mg/m3 for active pharmaceutical ingredients (API). Dust concentrations from the new dust emission points (A2-163, A2-166, A2-343 to A2-348 & A2-351) are anticipated to be below the emission limit value of 1 mg/m3 for total particulates and 0.15 mg/m3 for active pharmaceutical ingredients (API).

For

insp

ectio

n pur

pose

s only

.

Conse

nt of

copy

right

owne

r req

uired

for a

ny ot

her u

se.

EPA Export 25-07-2013:20:16:21

31

D.1.B Fugitive and Potential Emissions State whether the Council Directive 1999/13/EC on the limitation of emissions of volatile organic compounds due to the use of organic solvents in certain activities and installations apply to the operation:

Council Directive applies Yes No If yes, Attachment No D.1.B should include details of relevant category of activity in the Schedule and how the requirements in relation to fugitive emissions will be met.

Answer

D.1.B.1 Fugitive Emissions Section 5.2 of the 1994 IPC licence application P0004-01 detailed fugitive emissions that arise on-site. The nature of the proposed developments on-site will not lead to a significant increase in fugitive emissions from the site. As detailed in the 1994 Application, the main contributors to fugitive emissions from the site are the solvent storage tanks. At present GSK is considering options for:

1. Reuse of redundant storage tanks and recovery equipment for the storage and recovery of solvents associated with new products coming on site, and

2. Reducing the number of drums of solvents held on site by replacing these with bulk solvent storage tanks.

As and when these projects are approved by GSK for implementation, the Agency will be notified for approval. Potential for fugitive emissions and minimisation thereof will be addressed during the project design phases. The methodology used in the 1994 fugitive emissions study was adapted from a US EPA protocol developed for estimating VOC losses from process equipment. The US EPA protocol was modified where necessary to ensure confidence in the results generated. The study determined that the Fugitive Emissions escaping from the chosen process unit is equal to approximately 0.75 metric tons per year based on the US EPA Correlations. These losses are equivalent to 0.1% of annual solvent throughput or 4.2 kg of solvent losses per batch. D.1.B.2 Potential Emissions Potential emission points from the facility are included in Table 12A (vi) IPC Licence Application -1999 and identified in Drawing No.’s 3221/09/1188 & /1189 included in Attachment D.1.A. New Potential Emission Points associated with the proposed expansions include bursting discs on reactor vessels and filter dryers and pressure relief valves on new heat exchangers.

For

insp

ectio

n pur

pose

s only

.

Conse

nt of

copy

right

owne

r req

uired

for a

ny ot

her u

se.

EPA Export 25-07-2013:20:16:21

32

D.1. C Assessment of atmospheric emissions If relevant, give summary details and an assessment of the impacts of any emissions (as detailed above) on the environment, including environmental media other than those into which the emissions are being made. The assessment should include details of relevant ambient air quality standards. Details of the assessment and any other supporting information should form Attachment No D.1.C.

Answer The effect of atmospheric emissions downwind of the site was assessed through an Air Dispersion modelling assessment carried out for the IPC Licence Review Application 1998. A summary of the main conclusions from the worst case scenario of this assessment is provided in Attachment D.1.C. There have been no changes to the main emission points to atmosphere modelled from the site since this assessment was carried out, consequently the results of this assessment still apply to the current application. Reference - Section 4 of “Extra Information Report March 1999” submitted in support SmithKline Beecham’s IPC Licence Review application submitted in December 1998.

For

insp

ectio

n pur

pose

s only

.

Conse

nt of

copy

right

owne

r req

uired

for a

ny ot

her u

se.

EPA Export 25-07-2013:20:16:21

33

D.2. Emissions to Surface Waters Specify whether there has been a change in the quantity or nature of emissions to surface waters from that detailed in the original application or earlier review application(s) and/or specified in your existing licence:

Yes No If yes, provide further information as detailed below. D.2.A Emissions to Surface Water Outline significant adjustments to the operations on site, if any, which has led to a change in the quantity or nature of emissions to surface waters. A summary list of any revised emission points, together with maps/drawings (no larger than A3) and supporting documentation should be included as Attachment No D.2.A. The applicant should address in particular any emission point where those substances listed in the Schedule to the Environmental Protection Agency (Licensing) (Amendment) Regulations, 2004 (S.I. No. 394 of 2004) are emitted. State whether Water Quality (Dangerous Substances) Regulations, 2001 (S.I. No. 12 of 2001) apply to the operations on site:

Water Quality (Dangerous Substances) Regulations apply

Yes No

If yes, include in Attachment No D.2.A whether the operations on site comply with the prescribed standards set out in the S.I. No. 12 of 2001. For emissions outside the BAT guidance level, a full evaluation of the existing abatement/treatment system must be provided. A planned programme of improvement towards meeting upgraded standards in advance of 30th September 2007 is required. This should highlight specific goals and a time scale, together with options for modification, upgrading or replacement as required to bring the emissions within the emission levels as set out in the BAT guidance note(s).

Answer

There has been no change in the nature and quantity of emissions to surface water from SW01 from that detailed in the review application submitted in 1998 and existing IPC Licence P0004-02.

For

insp

ectio

n pur

pose

s only

.

Conse

nt of

copy

right

owne

r req

uired

for a

ny ot

her u

se.

EPA Export 25-07-2013:20:16:21

34

Ref No.: Description: Discharge to: SW01 Existing Process Effluent Diffuser Mouth of Lough Beg Bay, Cork Harbour D.2.A.1 Proposed Changes to Existing Licensed Parameters for SW01 GSK are however seeking to change some of the existing licensed parameters associated with SW01 as a result of the proposed new building projects and the proposed addition of a third surface water retention pond on-site. The proposed changes include; • Increase in the maximum volume to be emitted from process effluent diffuser

(SW01) in any one day from 1000 m3/day to 1,300 m3/day. • Corresponding increase in maximum rate per hour emission from 250 m3/hr to

325 m3/hr. • Reduction in the Licence Limit of 2,400 mg/L COD to 2,000 mg/L COD, in line

with GSK’s programme of continuous improvement (Refer to Attachment D.6, Table D.6.6)

The following streams feed into the WWTP: Strong Process Wastewaters: Direct aqueous discharges arising from normal production operations which are biologically treated prior to discharge to outfall. Weak Process Wastewaters: Wastewaters arising from floor washings from production areas and utility emissions which are biologically treated prior to discharge to outfall. Domestic Wastewaters: Wastewaters arising from sanitary services throughout the site which are biologically treated prior to discharge. These waters are routed via the submerged membrane WWTP which operates in parallel to the main section of the WWTP.

Air Emission Abatement Wastewaters arising from:

• Incinerator quench waters • Site emergency scrubber V3B

which are combined with the treated effluent from the wastewater treatment plant prior to discharge to outfall. A summary of the WWTP is included in Attachment D.2.A. Updated foul and process sewer layout drawings are also included in Attachment D.2.A. Projections have been made to quantify the maximum likely volumetric discharge of treated effluent (emission ref. SW01) from the GSK site up to the year 2010. The outcome of this investigation is as follows: • The maximum volume to be emitted in any one day will increase from the current

limit of 1000m3 to 1300m3 per day.

For

insp

ectio

n pur

pose

s only

.

Conse

nt of

copy

right

owne

r req

uired

for a

ny ot

her u

se.

EPA Export 25-07-2013:20:16:21

35

Rationale for volumetric increase from the WWTP • There will be an increase in the volume of weak process wastewater to the

WWTP as a result of the generation of floor washing from new buildings. Calculations of future floor washing volumes are based on proportional increases in volumes, per m2, using flows from existing buildings. The weak process wastewater volume to the WWTP will also be increased as a result of the increase in capacity of the firewater diversion pond system.

• It is planned to double the capacity of Building 35 for manufacture of Lapatinib, as

well as extend the Dutasteride facility (Area 79). This will result in additional flows of process drain streams to the WWTP.

• Domestic wastewater contributions to the WWTP will also increase as a result of

increased staff and contractor occupancy of the site. • Additional Firewater Retention Pond: It is proposed to increase in the capacity of

the firewater retention ponds by 180,000 gallons (817 m3). In the event of collection of contaminated firewater or contaminated surface water in these ponds which does not meet the conditions for release of TOC (200 mg/L) or pH (6-9), the contaminated stream will be directed to the WWTP via a dedicated line. The increased capacity of the retention ponds will impose an extra hydraulic load of up to 22% on the WWTP.

• Wastewaters, in the form of quench waters, arise from the two existing on-site

incinerators, i.e. incinerator No’s 1 and 3A. The combined waste stream from these sources is directed, following neutralisation, to the final holding tank where it combines with the treated effluent from the WWTP prior to being discharged on the ebbing tide to Lough Beg.

• The quantity of wastewater from these sources is expected to increase between

2006 and 2010 as a result of the proposed developments. Pollutant Parameter Emissions GSK is currently licensed for emissions from SW01 as follows: Table D.2.1 Current Licence Parameters for SW01

Emission Limit Values Parameter Mg/l Kg/day Total Ammonia (as N) 50 50 Suspended Solids 250 250 Zinc (as Zn) 1.0 1 Copper (as Cu) 0.5 0.5 COD 2400 2400 BOD 300 300 Nitrates (as N) 15 15 Phosphate (as P) 15 15

Through this review application GSK is seeking to amend some of the above emission limit values as follows;

For

insp

ectio

n pur

pose

s only

.

Conse

nt of

copy

right

owne

r req

uired

for a

ny ot

her u

se.

EPA Export 25-07-2013:20:16:21

36

COD, BOD, Phosphate GSK consistently achieves emission values for these parameters which are well below the current licence limits. Total Ammonia, Nitrates, Suspended Solids, Zinc, Copper GSK is consistently achieving emission values for these parameters which are within the current licence limits. However, based on the treatment efficiency of the existing WWTP and the nature of the wastewater to be treated, GSK requests that the existing concentration (mg/l) emission limit values (ELVs) for these parameters be maintained and that the daily mass (kg/day) ELV be increased in proportion to the projected maximum volumetric output, as included in Table D.2.2 below. A summary of the revised ELVs being sought is included in the following table, shown in comparison with projected normal daily average emission values for the same parameters. Table D.2.2 Proposed ELVs for IPPC Licence P0004-03

Proposed ELV’s Based projected maximum volumetric output of 1,300

m3/day

Projected Average Values Based on projected normal daily average volumetric output of 1000 m3/day.

Parameter

mg/l kg/day mg/l kg/day Total Ammonia (as N) 50 65 10 13 Suspended Solids 250 325 100 80 Zinc (as Zn) 1.0 1.3 0.2 0.26 Copper (as Cu) 0.5 0.65 0.1 0.13 COD 2,000 2600 600 780 BOD 300 390 80 104 Nitrate (as N) 15 19 5.0 6.5 Phosphate (as P) 15 19 6.0 7.8 GSK is confident that the emissions from the WWTP will be well below the proposed ELVs due to correct operation and appropriate monitoring, resulting in a negligible impact on Lough Beg. D.2.A.2 Stormwater Drainage The existing site surface water drainage collection systems will be extended to cover all new buildings and paved areas. The extended main site collection system will continue to drain via the existing storm/fire water diversion chamber to the combined storm water outfall SW02 on the northern boundary of the site. The existing car park collection system will continue to drain via the existing monitoring chamber to outfall SW03 on the western boundary of the site. Drawing No.’s 3221/09/1193 & 1194 included in Attachment D.2.A.2 outline the existing surface water drainage system on site. There will be no change to the nature of emissions to SW03 and SW02.

For

insp

ectio

n pur

pose

s only

.

Conse

nt of

copy

right

owne

r req

uired

for a

ny ot

her u

se.

EPA Export 25-07-2013:20:16:21

37

Details of the proposed additional firewater retention pond are included in Attachment F.1. D.2.B Assessment of Impact on Receiving Surface Water If relevant, give summary details and an assessment of the impacts of any emissions (as detailed above) on the environment, including environmental media other than those into which the emissions are to be made. The assessment should include details of relevant environmental quality standards or other legislative standards. Details of the assessment and any other supporting information should form Attachment No D.2.B.

Answer

A summary of the assessment carried out for the IPC Licence Review Application 1998 is included in Attachment D.2.B.

For

insp

ectio

n pur

pose

s only

.

Conse

nt of

copy

right

owne

r req

uired

for a

ny ot

her u

se.

EPA Export 25-07-2013:20:16:21

38

D.3 Emissions to Sewer Specify whether there has been a change in the quantity or nature of emissions to sewer from that detailed in the original application or earlier review application(s) and/or specified in your existing licence:

Yes No If yes, provide further information as detailed below. D.3.A Emissions to Sewer Outline significant adjustments to the operations on site, if any, which has led to a change in the quantity or nature of emissions to sewer. A summary list of any revised emission points, together with maps/drawings (no larger than A3) and supporting documentation should be included as Attachment No D.3.A. For emissions outside the BAT guidance level, a full evaluation of the existing abatement/treatment system must be provided. A planned programme of improvement towards meeting upgraded standards in advance of 30th September 2007 is required. This should highlight specific goals and a time scale, together with options for modification, upgrading or replacement as required to bring the emissions within the emission levels as set out in the BAT guidance note(s). D.3.B Assessment of Impact of Sewage Discharge. If relevant, give summary details and an assessment of the impacts of any emissions (as detailed above) on the environment, including environmental media other than those into which the emissions are to be made. The assessment should include details of relevant environmental quality standards or other legislative standards. Details of the assessment and any other supporting information should form Attachment No D.3.B.

Answer

There are no emissions to sewer from the GSK site.

For

insp

ectio

n pur

pose

s only

.

Conse

nt of

copy

right

owne

r req

uired

for a

ny ot

her u

se.

EPA Export 25-07-2013:20:16:21

39

D.4 Emissions to Ground Specify whether there has been a change in the quantity or nature of emissions to ground from that detailed in the original application or earlier review application(s) and/or specified in your existing licence:

Yes No If yes, provide further information as detailed below. D.4.A Emissions to Ground Outline significant adjustments to the operations on site, if any, which has led to a change in the quantity or nature of emissions to ground. For emissions outside the BAT guidance level, a full evaluation of the existing abatement/treatment system must be provided. A planned programme of improvement towards meeting upgraded standards in advance of 30th September 2007 is required. This should highlight specific goals and a time scale, together with options for modification, upgrading or replacement as required to bring the emissions within the emission levels as set out in the BAT guidance note(s).

Any supporting information should form Attachment No D.4.A.

Answer

There will be no ground emission points associated with the new buildings on-site. Attachment D.4.A details the existing measures on-site to protect the groundwater beneath the site. D.4.B Assessment of impact of ground/groundwater emissions If relevant, give summary details and an assessment of the impacts of any emissions (as detailed above) on the ground (aquifers, soils, sub-soils and rock environment), including any impact on environmental media other than those into which the emissions are to be made. This includes landspreading, land injection etc. Details of the assessment and any other supporting information should be included in Attachment No D.4.B.

Answer

Attachment D.4.B provides a summary of the status of the groundwater quality beneath the site.

For

insp

ectio

n pur

pose

s only

.

Conse

nt of

copy

right

owne

r req

uired

for a

ny ot

her u

se.

EPA Export 25-07-2013:20:16:21

40

D.5. Noise Emissions Specify whether there has been a change in the quantity or nature of noise emissions from that detailed in the original application or earlier review application(s) and/or specified in your existing licence:

Yes No If yes, provide further information as detailed below. D.5.A Noise Emissions Outline significant adjustments to the operations on site, if any, which has led to a change in source, location, nature, level and the time period or periods during which the noise emissions are made or are to be made. For emissions which lead to an impact in excess of the limits set out in the EPA Guidance Note for Noise for Scheduled Activities, a full evaluation of the existing abatement/treatment systems must be provided. A planned programme of improvement towards meeting upgraded standards in advance of 30th September 2007 is required. This should highlight specific goals and a time scale, together with options for modification, upgrading or replacement as required to bring the emissions within the required limits as set out in the Guidance Note for Noise for Scheduled Activities (1995). 1 Any supporting information should form Attachment No D.5.A.

Answer D.5.A Noise Emissions There have been no developments on site since 1998 that have led to a change in source, location or nature of noise emissions from site. The IPC licence specifies noise limits of 55 dB(A) daytime and 45 dB(A) at night-time at noise sensitive locations. These limits do not apply to location N2 (beach to north). A noise survey carried out in 2005 as summarised in the AER 2005 concluded that the daytime and night-time limits were met. The noise limits were also met at location N2 (beach), when allowance is made for the 2 dB interpretation margin in Condition 3.4 of the licence. Proposed Changes The proposed projects which could have an impact on noise levels are:

� Extension to Building 35 for Lapatinib 4 � Upgrade of Area 9/29 in Building 101 to deliver increased output of Lapatinib 3 � Expansion of Area 9 for Dutasteride � Associated Utility Building(s).

For

insp

ectio

n pur

pose

s only

.

Conse

nt of

copy

right

owne

r req

uired

for a

ny ot

her u

se.

EPA Export 25-07-2013:20:16:21

41

All new noise sources associated with the proposed projects are specified to <75 dB (A) at 1 m and will be located indoors or enclosed. Building cladding will provide at least 20 dB attenuation and all louvres will be acoustically attenuated. Calculations based on the information available on the proposed projects indicate that the proposed works will not affect noise levels at the designated noise sensitive locations off site. D.5.B Noise Impact. If relevant, give summary details and an assessment of the impacts of any emissions (as detailed above) on the environment, including environmental media other than those into which the emissions are to be made. 1

Details of the assessment and any other supporting information should be included in Attachment No D.5.B.

Answer

There have been very few noise complaints during the course of IPC Licence P0004-02. Details of the complaints and associated corrective actions are summarised in the AER Reports submitted to the EPA. There were a number of successful noise abatement projects carried out during the course of the present licence and these projects have been summarised in the AER Reports submitted to the EPA. As there have been no major developments on site which have led to a change in source, location or nature of noise emissions from site. A detailed assessment of impacts is not applicable to this Review Application.

For

insp

ectio

n pur

pose

s only

.

Conse

nt of

copy

right

owne

r req

uired

for a

ny ot

her u

se.

EPA Export 25-07-2013:20:16:21

42

D.6 Environmental Consideration and BAT Describe any environmental considerations which have been made with respect to the use of cleaner technologies, waste minimisation and raw material substitution since the grant of the existing licence. Describe the measures proposed or in place to ensure that the Best Available Technique (BAT) will be used to prevent or eliminate or, where that is not practicable, generally reduce an emission from the activity. Supporting information should form Attachment No D.6.

Answer

The following sections and the supporting information in Attachment D.6 (Tables D.6.1 to D.6.9) demonstrate that GSK is operating in a manner that takes all the appropriate preventative measures against environmental pollution through the application of Best Available Techniques (BAT). D.6.1 Environmental considerations which have been made with respect to the

use of cleaner technologies, waste minimisation and raw material substitution since the grant of the existing licence.

D.6.1.1 Use of Cleaner Technologies � Application of Selective Catalytic Nitrogen Oxide Reduction technology to

existing incinerators

Selective Catalytic Nitrogen Oxide Reduction (SCNR or “DeNOx”) units were installed in the flue gas trains on Incinerator No. 3 in 2001 and Incinerator No. 1 in 2004. In addition to the removal of nitrogen oxides (NOx), these units destroy dioxins and furans in the vent gases. In the DeNOx units, the nitrogen oxides are reacted with aqueous ammonia at 330°C in the presence of a catalyst (titanium oxide, vanadium oxide and tungsten oxide) to produce nitrogen and water. The DeNOx units have been highly effective in maintaining NOx concentrations well below IPC Licence limits.

� Waste heat recovery

The installation of Incinerator No. 3A in 2001 resulted in the generation of steam by recovery of heat from the hot gases from the firebox of the unit using a waste heat boiler. The hot gases from the firebox pass through an array of boiler tubes where steam is generated for use on site. Approximately 70 % of the site’s steam demand is provided by the waste heat boiler.

For

insp

ectio

n pur

pose

s only

.

Conse

nt of

copy

right

owne

r req

uired

for a

ny ot

her u

se.

EPA Export 25-07-2013:20:16:21

43

The hot gases exit from the boiler at ~ 400°C and are quenched in the immersion tank and then pass through an acid and particulate removal scrubber train. The gases then exit via a DeNOx module to atmosphere.

� Carbon dioxide reduction

The reduction in usage of natural gas in the steam boiler led to a reduction in generation of 6400 MT carbon dioxide emissions from 2001 to 2002 due to the installation of the Waste Heat Boiler on Incinerator No 3.

� Installation of submerged membrane bio-reactor in the WWTP

A submerged membrane Membrane Bio-Reactor (MBR) unit was installed in 2002 to run in parallel with the existing extended aeration wastewater treatment plant. Filtered toilet waste, weak contaminated streams and bund drainings are diverted to the MBR unit. The MBR has the advantage of having a small footprint area and can take mixed liquor suspended solids concentrations of up to 12,000 mg/l as against approximately 4500 mg/l in a conventional plant with gravity clarification. The membranes can filter out the biosolids and produce a permeate of suspended solids of < 5 mg/l.

� Diversion of process waste streams to the WWTP

A 100 litre pilot wastewater treatment unit in the Environmental Laboratory has been set up and used in studies on the suitability of process waste streams for use in the plant Wastewater Treatment Plant. Two process waste streams (Paroxetine Stage 1 and Filtered GW406381X) have been evaluated and found suitable for use in the WWTP. The diversion of these streams to the WWTP has been included in correspondence to the EPA. Diversion of the Paroxetine Stage 1 stream has resulted in a reduction of approximately 1000 MT of salty waste being sent to the site incinerator.

For

insp

ectio

n pur

pose

s only

.

Conse

nt of

copy

right

owne

r req

uired

for a

ny ot

her u

se.

EPA Export 25-07-2013:20:16:21

44

D.6.1.2 Waste Minimisation and Raw Material Substitution

A summary of waste minimisation raw material substitution initiatives on site since the 1998 IPC Licence Application was submitted is presented in the following table:

Table D.6.10 Waste Minimisation and Raw Material Substitution Initiatives at GSK since IPC Licence P0004-02 was issued. Year Project Details Investigate the use of FIBCs to

replace the drums being used on site

FIBC storage/usage for : • WWTP antifoam • Urea for Incinerator No. 3 DeNOx

1999 to 2006

Bunds for intermediate drum storage were constructed near the Environmental area in front of buildings 101,120, 6001, 7001 and 7601

All areas indicated were used for intermediate drum storage.

Divert the disposal of solvent layer aqueous washes away from incineration to the WWTP

Solvent layer aqueous washes sent to the WWTP for the whole year.

2001 Installation of a DeNox Unit on an incinerator

Installation of a SCNR DeNOx unit on Incinerator No. 3 (V3)

2002 Installation of a waste heat boiler on Incinerator No. 3.

Installation of a WHB resulted in the reduction in run time of the site’s steam boiler. As a result of this, the use of natural gas on site was reduced by approx 1,000,000 Therms from 2001 to 2002.

Recycling of solvents from processes

Toluene, Methylene Chloride, Methanol and Ethyl Acetate are now being recovered on a routine basis. These recovered solvents are being recycled into the manufacture of products on site. Trials on the recovery of Acetone on site were successfully carried out. Acetone is now recovered on a regular basis.

2001 Investigate the use of FIBC’s / bulk storage to replace the use of drums for waste storage on site.

A bulk tank was installed for storage of Dimethyl Ethyl Amine during 2001, saving in excess of 100 drums/year and associated odour related handling.

Waste reduction in Paroxetine Stage 1

Second salt wash on Stage 1 successfully removed. This accounted for a drop of 40 % in the total amount of salt (Sodium Chloride) used in the input materials.

2001 Solvent substitution of Chlorinated Hydrocarbon in Paroxetine 4 process.

In Q3 2001, Methylene Chloride was replaced by Toluene in Paroxetine Stage 4

2001 Solvent substitution of Dimethylformamide in Paroxetine 4 process.

In Q3 2001, Dimethylformamide was replaced by Isopropyl Alcohol in Paroxetine Stage 4

2003 Water reduction in Paroxetine Stage 3 – Use of CINC extractor planned.

Cinc extractor was installed in October 2003 and has achieved the objective of reducing water usage by 1800 L per batch.

2004 Continuation of pilot bioplant studies in 2004 for the diversion of waste streams from

A Pilot Plant Study on diversion of an aqueous stream from the site Nanomilling facility was completed and approved by the EPA

For

insp

ectio

n pur

pose

s only

.

Conse

nt of

copy

right

owne

r req

uired

for a

ny ot

her u

se.

EPA Export 25-07-2013:20:16:21

45

Year Project Details incinerator V1 and V3 to the WWTP

2004 Improved process control (equipment and management) to increase the volume of solvent waste sent for recovery

Development work on diverting solvent streams from incineration to on site solvent recovery plant resulted in the following additional quantities being recovered and used on site in 2004: • Ethanol 352.5 T • Isopropyl alcohol 95.6 T • Toluene 257 T

2004 To reduce the amount of dewatered WWTP sludge being disposed of to landfill.

Since Q1, 2004 all dewatered sludge has been diverted away from the East Cork Landfill. During 2004, the sludge was sent to a blending station in Minane Bridge and from there to Germany for drying and subsequent incineration. In 2005, the sludge has been sent to McGill Environmental for composting and onwards to Belgium for use in a cement kiln.

2004 Installation of a DeNox Unit on an incinerator

Installation of a DeNOx unit on Incinerator No.1 (V1) in September 2004. This selective catalytic nitrogen reduction (SCNR) DeNOx unit is similar to the SCNR DeNOx unit installed on Incinerator No. 3 (V3) in 2001.

2005 To improve waste management on-site and implement a single waste management system that tracks both hazardous and non-hazardous waste on-site.

Implement a Total Waste Management System (TWM) at GSK to be managed by Indaver (Ireland): • A full time Waste Operations Leader has been

present on site from the beginning of March 2005

• All waste movements off site are entered on a waste management tracking system

• Weekly reviews are held between GSK and Indaver to track progress of the TWM system and to identify additional opportunities for waste reduction.

2005 Diversion of food waste away

from landfill.

Food waste from the on-site cafeteria is sent for treatment to Milltown Composting, Fethard, Co.Tipperary. This also comes under the remit of the Total Waste Management (TWM) system on-site.

2005 To replace the once-off use of disposable 200L drums for the disposal of Lithium Aluminium Hydroxide sludge with reusable ASP containers (metal IBCs).

To dispose of Lithal waste solid (Lithium Aluminium Hydroxide wet solid from Paroxetine Stage 2) in returnable ASP containers for high temperature burning in a cement kiln: • Wet cake Lithium Aluminium Hydroxide

(“Lithal”) is discharged into ASP containers on the GSK site ~ 800 Kgs/container.

• Contents of ASPs blended with other solids in Scoribel (Belgium) and empty ASPs will be returned to GSK to be filled again with Lithal waste solid.

• The blended material is combusted in the cement kiln in HOLCIM (Belgium).

2006 Elimination of Methyl Control of an odorous compound like Methyl

For

insp

ectio

n pur

pose

s only

.

Conse

nt of

copy

right

owne

r req

uired

for a

ny ot

her u

se.

EPA Export 25-07-2013:20:16:21

46

Year Project Details Mercaptan. Two stages of Cimetidine generated Methyl Mercaptan as a by-product and this compound, which has an odour threshold of 2 ppb, was the source of odour complaints over the period from 1976 to 2006.

Mercaptan was difficult despite the fact that the compound was incinerated and scrubbed. In 2006, Cimetidine manufacture ceased on site and this significantly reduced the potential for odour complaints.

D.6.2 Measures in place to ensure that the Best Available Technique (BAT) will be

used to prevent or eliminate or, where that is not practicable, generally reduce an emission from the activity.

BREF (BAT Reference Documents) applicable to GSK include:

� BREF document on the General Principles of Monitoring � BREF in Common Waste Water and Waste Gas Treatment /Management

Systems in the Chemical Sector � BREF on Emissions from Storage � BREF on the Manufacture of Organic Fine Chemicals � BREF for Waste Incineration.

GSK has taken due regard of the specifications in these guidelines in the preparation of this Licence Review Application with regard to all new and existing developments. Section 83(5)(v) of the Protection of the Environment Act 2003 states that the Agency shall not grant a licence for an activity unless it is satisfied that:

“any emissions from the activity will not cause significant environmental pollution”.

GSK has shown during the life span of the previous two IPC Licences that emissions from the site do not cause any significant environmental pollution. There is a high level of environmental protection on-site. The BAT measures in place on site, described in detail in Attachment D.6 ensure that the site has reduced to a minimum the overall impact of emissions on the environment and the associated risks to it. The tables presented in Attachment D.6 compare BAT requirements for the industry1 and existing practices on-site.

1 BAT Guidance Note on Best Available Techniques for the Manufacture of Organic Chemicals

For

insp

ectio

n pur

pose

s only

.

Conse

nt of

copy

right

owne

r req

uired

for a

ny ot

her u

se.

EPA Export 25-07-2013:20:16:21

47

D.6.3 Measures proposed to ensure that the Best Available Technique (BAT) will be used to prevent or eliminate or, where that is not practicable, generally reduce an emission from the activity.

Some measures one site are aimed at meeting BAT as discussed below; further measures are discussed in Attachment D.6 (Tables D.6.1 to D.6.9). Firewater Retention Pond The site currently has two firewater retention ponds of capacity 3,640 m3 to safely retain fire fighting water and contaminated surface water. Installation of an additional firewater retention pond of 800m3 capacity will ensure that there is sufficient retention capacity on site to allow for the proposed new building developments. Refer to the drawing in Attachment F.1 regarding the proposed additional retention pond. HEPA Filtration High efficiency particulate filters (HEPA filters) are installed as standard on all new dust emission points to atmosphere from which there is potential for loss of dust or particulates. Noise Reduction Noise abatement measures and appropriate location of equipment is included in the specification of design for all proposed projects. GSK will ensure that any new developments on-site will be in accordance with BAT.

For

insp

ectio

n pur

pose

s only

.

Conse

nt of

copy

right

owne

r req

uired

for a

ny ot

her u

se.

EPA Export 25-07-2013:20:16:21

48

SECTION E CONTROL AND MONITORING Describe any adjustment (not detailed in Section C) made to technology and other techniques for preventing or, where this is not practicable, reducing emissions from the installation. E.1: Treatment, Abatement and Control Systems Details of revised treatment/abatement systems (air and effluent emissions) should be included, together with schematics as appropriate. Attachment No E.1 should contain any supporting information. E.2: Emissions Monitoring and Sampling Points Identify any revised monitoring and sampling points and outline any revised or updated proposals for the monitoring of emissions. Attachment No E.2 should contain an updated drawing (no larger than A3) detailing all proposed monitoring points including National Grid References (12 digit 6E, 6N).

Answer

E.1: Treatment, Abatement and Control Systems E.1.1 Air Emissions There were no changes to the air emissions abatement system in the course of Licence 473 (P0004-02) apart from those detailed in Section C as approved by the EPA. Additional emission points installed in the course of Licence 473 (P0004-02) are detailed in Section D.1.A. E.1.2 Effluent emissions There were no changes to the effluent abatement system in the course of Licence 473 (P0004-02) apart from those detailed in Section C as approved by the EPA. There were no additional effluent emission points installed in the course of Licence 473 (P0004-02). There is no plan to install an additional point of emission.

For

insp

ectio

n pur

pose

s only

.

Conse

nt of

copy

right

owne

r req

uired

for a

ny ot

her u

se.

EPA Export 25-07-2013:20:16:21

49

E.2: Emissions Monitoring and Sampling Points Drawing No.’s 3221/09/1191 and 3221/09/1192 included in Attachment E.2 provide an updated illustration of the monitoring and sampling points on-site. E.2.1 Air Emissions GSK request the following changes in monitoring and frequency of monitoring on the following Air Emission Points. Dust Vents are sampled and analysed once per year under the present IPC Licence . In 12 years of testing since the issue of Licence P0004-01, there has been only one failure to reach the required licence standard. This vent, V9, has been removed from the plant as it is no longer required. GSK request that each vent as outlined in Table E.2.1 below be sampled and analysed every two years with half of the emission points sampled/analysed in year one and the other half sampled/analysed the following year. Table E.2.1 API Dust Extract Vents

IPC Application Reference - Table 12 (ii) IPC Application March ’99 Extra Information Report Section 5 (Page 2 – 61) A2-10 (V10) A2-146 (V146) A2-317 ( V317) A2-12 (V12) A2-149 (V149) A2-318 ( V318) A2-13 (V13) A2-150 ( V150) A2-319 (V319) A2-14 (V14) A2-152 ( V152) A2-320 ( V320) A2-112 (V112) A2-162 (V162) A2-325 ( V325) A2-116 (V116) A2-301 (V301) A2-328 ( V328) A2-123 (V123) A2-303 (V303) A2-124 (V124) A2-308 (V308) A2-128 (V128) A2- 316 (V316) IPC Application Reference - Additional vents installed since IPC Licence P0004-02 was granted in 1999. See Section D for further details. A2-338 (V338) A2-341 ( V341) A2-339 (V339) A2-342 (V342) A2-340 (V340) Proposed new main emission points to be included in IPPC Licence P0004-03

A2-163 A2-166 A2-343 to A2-348 A2-351

E.2.2 Effluent Emissions GSK request the following changes as outlined in Table E.2.2 in monitoring and frequency of monitoring on wastewater emission point SW01:

For

insp

ectio

n pur

pose

s only

.

Conse

nt of

copy

right

owne

r req

uired

for a

ny ot

her u

se.

EPA Export 25-07-2013:20:16:21

50

Table E.2.2 Proposals for Monitoring Wastewater Emissions from SW01

Test Frequency of test in

current Licence P0004-02

Proposed Frequency of test in Proposed Licence P0004-03

Rationale for request (as supported by data

summarised in the AER Reports)

Nutrient Balance Twice weekly Once weekly Plant performance

indicates good nutrient balance.

Total Organic Carbon (TOC)

Was previously a daily requirement in original draft of licence – this was changed to weekly with the agreement of the EPA

Eliminate this test There is poor correlation between TOC and COD

BOD Once weekly Once per month BOD has been consistently low and well below limit

Organic Solvents Four times a year Two times a year Organic solvents have been at a very low level

Copper Once a month Once a quarter From start of 2004 to end of 2005, Cu has been an average of 5% of the limit.

Zinc Once a month Once a quarter From start of 2004 to end of 2005, Zn has been an average of 6.9% of the limit.

E.2.3 Requested changes to Monthly / Quarterly Reporting During the course of IPC Licence 473 (P0004-02), site performance reports were created on a monthly and quarterly basis detailing the following monitoring results:

� Incinerator Air emissions � API Dust emissions � Wastewater Treatment Plant Emissions � Surface Water emissions � Analysis of WWTP sludge � Odour / Noise complaints � Incinerator waste stream composition

These reports have been completed as per IPC Licence requirements and are stored on site for inspection by the EPA inspectorate on request. GSK request that the EPA consider removing the requirement to submit these reports on a monthly and quarterly basis in the IPPC Licence as the site performance is covered in detail in the Annual Environmental Report (AER) and all monitoring information on the above areas can be readily accessed from computer databases on request. This data is reviewed continually by GSK.

For

insp

ectio

n pur

pose

s only

.

Conse

nt of

copy

right

owne

r req

uired

for a

ny ot

her u

se.

EPA Export 25-07-2013:20:16:21

51

In the event of any non conformance, Licence Limit exceedence or receipt of a complaint GSK would report details to the EPA immediately and initiate appropriate corrective actions procedures.

For

insp

ectio

n pur

pose

s only

.

Conse

nt of

copy

right

owne

r req

uired

for a

ny ot

her u

se.

EPA Export 25-07-2013:20:16:21

52

SECTION F ACCIDENT PREVENTION & EMERGENCY RESPONSE

Describe the existing or proposed accident prevention measures and procedures. Provide details of emergency procedures to minimise the impact on the environment of an accidental emission or spillage. Also outline what provisions have been made for response to emergency situations outside of normal working hours, i.e., during night-time, weekends and holiday periods. Describe the arrangements for abnormal operating conditions including start-up, leaks, malfunctions or short-term stoppages. Supporting information should form Attachment No F.

Answer

F.1 Existing accident prevention measures and procedures GSK is committed to maintaining an on-site capability, based on risk assessment, to deal with foreseeable hazards associated with its operations, such as fire, gas release, spillage and personal injury. Site Emergency Response Procedure SAFP-003 is in place to deal with any on-site emergencies. This procedure sets out the action to be taken by the Emergency Response Team (ERT) and all employees. The Emergency Response procedure includes strategies for managing: • Chemical Fire and Spillage • Identified Major Accident Hazards and Reporting (Ref. SI 74 of 2006 Control of

Major Accident Hazards Involving Dangerous Substances) • Environmental Emergencies The Emergency Response procedure is discussed in more detail in Section F.2 below. The site is designated as a top tier Seveso II site. Quantities of toxic and flammable substances on-site exceed the qualifying quantities set out in the First Schedule of the European Communities (Control of Major Accident Hazards Involving Dangerous Substances) Regulations, 2006, S.I. 74 of 2006.

The site is therefore required to produce a Safety Report under Regulation 12 of the above Regulations. A Safety Report was submitted to the HSA in October 2004. The purpose of the Safety Report is to: • demonstrate that a Major Accident Prevention Policy (MAPP) and a safety

management system for implementing it have been put into effect;

For

insp

ectio

n pur

pose

s only

.

Conse

nt of

copy

right

owne

r req

uired

for a

ny ot

her u

se.

EPA Export 25-07-2013:20:16:21

53

• demonstrate that major accident hazards have been identified and that the necessary measures have been taken to prevent such accidents and to limit their consequences, should an accident occur, to people and the environment;

• demonstrate that adequate safety and reliability have been incorporated into the design and construction, and operation and maintenance of installations, storage facilities, equipment and infrastructure connected with its operation which are linked to major accident hazards inside the establishment;

• demonstrate that internal emergency plans have been drawn up and supplying information to enable the external plan to be drawn up in order to take the necessary measures in the event of a major accident;

• provide sufficient information to the competent authorities and planning authorities to enable decisions to be made in terms of the siting of new activities or developments around existing establishments.

• maintain an updated inventory of the dangerous substances in the establishment.

Integral to accident prevention measures on-site are the following existing features, systems and procedures: • All GSK processes are properly designed and built to ensure that they are

operated and maintained safely. A system of operating procedures are in place for all systems and these are periodically reviewed and updated.

• GSK ensures identified process safety requirements and operating conditions are always met by employing good engineering practices, Corporate Codes and Standards.

• A series of Environmental and Health and Safety Procedures are in place to ensure that all activities are carried out in such a manner as to prevent, control and limit accidents, emergencies and environmental damage on-site. A list of active EH&S procedures are included in Attachments F.1.1 and F.1.2.

• A Total Waste Management system is in operation on-site to ensure all hazardous and non hazardous waste materials are correctly managed, stored and disposed.

• A site wide EHS training programme is in place, and all new employees are trained on technical issues as appropriate.

• A Hazard Communication Training Programme (covered by site Hazard Communications SAFP014) provides information to identify the hazards associated with chemicals and how to work safely with them.

• Manufacturing processes on site are controlled with the aid of Programmable Logic Control (PLC) and/or Distributed Control System (DCS).

• For all safety and environmental related control systems, all equipment is purchased from approved suppliers and manufacturers.

For

insp

ectio

n pur

pose

s only

.

Conse

nt of

copy

right

owne

r req

uired

for a

ny ot

her u

se.

EPA Export 25-07-2013:20:16:21

54

• With regard to the design of safety related control systems, all designs are risk assessed and subject to site validation procedures.

• All processes are designed with fail safe positions as determined at Hazop or detail design stage.

• All large projects are carried out under the supervision of external engineering companies and undergo detailed design reviews. For smaller projects the project engineer ensures that design safety and environmental issues are reviewed.

• In all projects, plant and equipment are designed to the appropriate standards with process (temperature, pressures, chemical composition etc.), maintenance (accessibility, frequency etc.) and general environmental (corrosion, loading, impact, weathering) considerations taken into consideration, via Hazop or Change Control procedure.

• A preventive maintenance (PM) system is in place through which routine maintenance checks are carried out and results recorded for e.g. pipelines are visually inspected weekly for leaks. An Engineering Operations Maintenance protocol is in place for calibration and preventive maintenance of safety critical instrumentation and equipment.

• Corporate Performance Assessments are carried out every three years on the plant’s safety and environmental systems.

Containment on-site • Site Spillage Procedure (ENVP042), details the various response measures and

treatment of released materials.

• All external chemical storage tanks are located in sealed bunds, which are hydraulically tested every three years. All solvent storage tanks are fitted with level indicators linked to the PLC or DCS system. Overfilling of tanks is prevented by automatic shut down of the valve on the fill line when the level in the tank reaches a certain percentage fullness.

• All surface water run-off is fed by gravity into a monitoring chamber which continuously monitors the TOC and pH using inline instrumentation. Where the surface water has a trace of organic contamination or a pH reading outside the range of 6-9, it will be automatically diverted to one of the two firewater retention ponds.

• All surface water drains (existing and new) can be automatically directed to the two surface water retention ponds and prevented from entering Loughbeg in the event of contamination or a fire. Updated surface water drawings are provided in Attachment D.2.A.2. In 2005 an additional penstock valve to work in parallel with the existing disposal line to the harbour was installed in the surface water outlet.

• With the existing, new and proposed developments on-site it is planned to install an additional surface water pond adjacent to the two existing ponds to cater for the increased surface water on-site.

For

insp

ectio

n pur

pose

s only

.

Conse

nt of

copy

right

owne

r req

uired

for a

ny ot

her u

se.

EPA Export 25-07-2013:20:16:21

55

• The retention capability1 of the two existing surface retention ponds as described in the 1998 IPC Application is 3640 m3. With recent developments on-site and proposed building projects, it was determined from this same study that a retention capacity of 4436 m3 would be required for such development and expansion.

In support of the above measures, the following drawings are included in Attachment F.1 for reference:

Attachment F.1.3 Proposed Firewater Retention Pond

Attachment F.1.4 Site Plan – Fire Protection

Attachment F.1.5 Site Plan - Tankage

F.2 Details of emergency procedures to minimise the impact on the environment of an accidental emission or spillage It is the policy of GSK to be fully prepared and have suitable mitigation measures in place for any foreseen emergency such as flammable liquid releases, flammable gas emissions, fire, toxic gas emissions, and other potential hazards associated with its operations. All material safety data sheets for materials stored on site are available electronically on the system and hardcopies are available at Security. Emergency Response Procedure GSK has a Site Emergency Procedure (SAFP-003) in place, which details the emergency response procedures for the facility. This sets out the action to be taken by the Emergency Response Team (ERT) and all employees. The purpose of the procedure is to provide intervention measures to protect people, the community and minimise the effect on the environment. GSK is operates a continuous 24 hour, 7 days per week production facility and is consistently monitored and controlled on this basis. The Emergency Response Procedure is effective 24 hours, 7 days per week and is set out to deal with emergencies any time of the day or night and during weekends.

The ERT is composed of the following members trained in firefighting, handling toxic release and chemical spillages:

• Incident Controller • Fire Team • First-Aider/Ambulance Drivers • Shift IPC Chemist • Shift Fitter and Electrician • Sprinkler Valve Controller • Security Guards.

1 This capacity is based on 4 hour fire in the main production building and a rainfall level of 1” during the fire. This calculation is based on EPA guidance document on firewater design and all design parameters have been agreed with the EPA.

For

insp

ectio

n pur

pose

s only

.

Conse

nt of

copy

right

owne

r req

uired

for a

ny ot

her u

se.

EPA Export 25-07-2013:20:16:21

56

Activation of the Fire Alarm automatically summons the ERT into action. It also puts all computer-controlled processes to a safe-status condition. This shuts all solvent supplies to vessels. Site Spillage Procedure The Site Spillage Procedure (ENVP042) details the various response measures and treatment of released materials. Liquid spillages/firewater effluent from process areas and drum parks are drained to enclosed tanks located in sumps, and pumped to the wastewater treatment plant. In the event of large flows from buildings, overflows may occur at the tanks and the secondary containment sumps will overflow to the surface water drains. Any detection of contamination by the TOC or pH meters at the surface water monitoring point (SW2) will automatically divert the contaminated surface water to the Fire Water Retention Pond. Spill response kits are available at key locations on-site. These kits contain supplies of adsorbent, spill booms, drain covers and pillows. These kits can be used as immediate spill containment, holding material until it can be removed to a suitable location. There is a portable pump available on-site, which can be used to pump spilt materials into bunds, IBC’s or other fixed tanks. In an emergency situation where large quantities of contaminated water enter the bio plant balance tank, feed forward to the activated section of the WWTP will be stopped. Both pH and dissolved oxygen are continuously monitored to detect if a high organic load is entering the activated section. The WWTP is continuously monitored by environmental operators 24 hours a day. Where the balance tank cannot cope with the quantity, liquid waste can be transferred to liquid storage tanks located adjacent to the WWTP for subsequent treatment. Major Accident Scenario Various predetermined response plans for major accident scenarios have been developed for the site’s Seveso II Safety Report. Within each of these plans, environmental considerations have been addressed as part of the response plan where an environmental issue arises. A list of the Seveso II Response Scenarios are included in Attachment F.2.1. A Site Crisis Management Plan is in place to prepare the site in the event of a major accident. Site crisis management training is conducted twice per annum. F.3 Arrangements for abnormal operating conditions including start-ups, leaks, malfunctions or short-term stoppages. The Site Emergency Response Procedure and Site Spillage Procedure have been developed to deal with any incidents arising from abnormal operating conditions. Site specific operating procedures and training are in place to manage start-ups, malfunctions and short-term stoppages of equipment. All reportable incidents such as malfunctions or breakdown of control equipment or monitoring equipment or any incident with the potential for environmental contamination are reported to the EPA/HSA detailing the cause and corrective action taken. Every effort is made to ensure that the corrective action prevents a reoccurrence of the incident. A standard operating environmental procedure

For

insp

ectio

n pur

pose

s only

.

Conse

nt of

copy

right

owne

r req

uired

for a

ny ot

her u

se.

EPA Export 25-07-2013:20:16:21

57

ENVP055 is in place for “Non Conformance Corrective Action Procedure”. Procedures for reporting of Environmental and Safety Incidents are detailed in Safety Procedure SAFP018: EHS Accidents and Incidents – Reporting and Investigations. Environmental incidents are summarised on an annual basis in the AER.

For

insp

ectio

n pur

pose

s only

.

Conse

nt of

copy

right

owne

r req

uired

for a

ny ot

her u

se.

EPA Export 25-07-2013:20:16:22

58

SECTION G RESOURCE USE & ENERGY EFFICIENCY

Provide a description of resources used, energy used or energy generated by the activity. Provide summary information on the details and results of any previously conducted audit of the energy efficiency of the site. (See note 1 below in relation any proposal to carry out an audit.) Outline the measures taken to ensure that resources and energy are used efficiently in the operation. The information on resource use and energy efficiency should form Attachment No G. Note 1: Any proposed audit which is to be conducted after the submission of this application shall

be carried out in accordance with the guidance published by the Agency “Guidance Note on Energy Efficiency Auditing”. The audit shall identify all opportunities for energy use reduction and efficiency.

Answer

G.1 Raw Materials Usage The nature and quantity of all materials handled on site are catalogued in the 1998 IPC Licence Review Application. All new materials introduced onto the site in significant quantities since the issue of this Licence have been notified to the Agency in accordance with Condition 1.2 of the IPPC Licence. Please refer to the table included as Attachment C to this application, which lists the changes notified by GSK to the Agency and approved by the Agency since the most recent licence was issued. In accordance with Condition 1.2 of the IPPC Licence, GSK will continue to notify the Agency and seek written approval before any new materials are used on site. GSK has installed a Systems, Applications, Procedures (SAP) system for tracking raw materials and products. The system is used for:

• Inventory management • Purchasing • Billing and Sales analysis • Release management • Outbound logistics management.

The Materials Manager controls this system.

For

insp

ectio

n pur

pose

s only

.

Conse

nt of

copy

right

owne

r req

uired

for a

ny ot

her u

se.

EPA Export 25-07-2013:20:16:22

59

G.2 Energy Usage GSK does not generate any energy directly on site. The sources of energy used on site are:

• Electricity - used for heating, lighting, control systems, process equipment, maintenance workshop, etc.

• Natural Gas – used to generate steam in the boilers and to supplement fuel requirements for the incinerators. Waste heat from the incinerators is re-used to generate steam.

• Diesel oil – used for the two standby generators and two standby fire pumps, forklift trucks, and site vehicles.

• Liquefied Petroleum Gas (LPG) – used in forklift trucks. The usages of these energy sources in 2005 are shown in Table G.2.1 below. Table G.2.1 Energy usage on site in 2005 Energy Source Site Usage (KWh) % of Total Energy Usage Electricity 54,641,173 52 Natural Gas 47,974,272 46 Diesel oil 1,799,768 2 LPG 6,814 negligible A detailed discussion of the usage and management of energy on the site is given in Attachment G.1. G.3 Energy Efficiency G.3.1 Introduction GSK has entered into the European Union Emission Trading Scheme, which aims to reduce the permitted levels of carbon dioxide emissions over a period of years. The site has been granted a Greenhouse Gas Permit from the EPA, permit number IE-GHG-095-02. This authorises GSK to undertake named activities resulting in the emissions of carbon dioxide from listed emission points. It also contains requirements in respect of such emissions, including monitoring and reporting requirements. Allowances for emissions to air from greenhouse gases (GHGs) are allocated through the National Allocation Plan. Holders of GHG permits may buy and sell allowances. To achieve energy efficiency, energy management is coordinated between different production areas within the site by the implementation of an Energy Management Policy. The implementation of the Energy Management Policy ensures clear accountability for the management of energy as a resource, across the site. G.3.2 Energy Management Policy GSK is part of the Primary Supply and Antibiotics Group of GlaxoSmithKline. It is the policy of the Primary Supply and Antibiotics Group to:

• Seek to maximise the energy efficiency of all Primary Site operations; • Reduce energy consumption and costs; • Meet GSK Corporate targets for energy consumption reduction.

For

insp

ectio

n pur

pose

s only

.

Conse

nt of

copy

right

owne

r req

uired

for a

ny ot

her u

se.

EPA Export 25-07-2013:20:16:22

60

This policy is achieved by coordinated auditing, monitoring and setting future targets for each site. The GSK Corporate Policy is also supported by a local GSK Cork Energy Strategy, Energy Policy and Energy Efficiency SOP ENVP024. The Cork Energy Policy aims to:

• Maximise the energy efficiency of all operations; • Reduce energy consumption and costs; • Meet GSK Corporate targets for energy consumption reduction.

This Cork energy policy is implemented by: • Setting targets for energy consumption reduction; • Increasing staff awareness of energy consumption, costs and environmental

impact; • Increasing ‘ownership’ of energy consumption in all areas; • Promoting more efficient use of energy for new and existing installations; • Sharing best practice on energy efficiency and energy consumption reduction.

G.3.3 Monitoring Performance The site reviews key performance indicators within the utilities areas and total site energy consumption on a weekly basis. The weekly energy consumptions are reconciled with production data on an annual basis, allowing performance to be assessed in terms of specific energy consumption and targets and reported to Sustainable Energy Ireland as part of the Large Industries Energy Network scheme. The site data is collated with data from other GSK divisions and performance monitored against agreed savings targets. The monthly corporate energy report forms the data used for the EPA annual carbon dioxide emissions reporting. GSK has recently approved a metering project to improve data gathering infrastructure. This was combined with the purchase of Monitoring and Targeting software to form part of an integrated network across GSK sites to share best practice and to seek saving opportunities.

G.3.4 Energy Audit - Developing energy reduction targets and plans Energy reduction plans for the site were developed using the output from an Energy Audit by members of the Primary Antibiotics Supply in February, 2002. As part of the energy reduction plans, a system of routine energy audits was established to ensure that the site carries out the following:

• Establish plans for mapping of energy use and targets by production area; • Locate of energy wastages; • Identify further energy saving opportunities; • Develop and implement an effective site energy management programme of

measures to reduce overall energy consumption.

Based on the outcome of the routine audits, energy reduction targets are set for the site taking into account any future potential projects.

Energy efficiencies are also considered in any potential new design or modification of existing buildings and plants. A cost-effective energy efficiency plan will be developed for any new plants.

For

insp

ectio

n pur

pose

s only

.

Conse

nt of

copy

right

owne

r req

uired

for a

ny ot

her u

se.

EPA Export 25-07-2013:20:16:22

61

The annual energy audits are ongoing. GSK is also subject to EHS audits which include a review of performance against the GSK Global EHS Standard 502, Energy Efficiency.

Corporate project investment sanction for larger projects is dependent on satisfactory demonstration of appropriate energy efficiency considerations.

G.3.5 Energy Manager To ensure that energy is effectively managed on the site, a site Energy Manager was appointed in 2002. It is the responsibility of the Energy Manager to monitor and report energy consumption and performance trends and immediately address and deviations; set and monitor progress on key annual targets relating to energy efficiency; conduct periodic audits to review various aspects of the energy management policy and comply with new regulation proposed under the EU Emissions Trading Scheme. The Energy Manager will work co-operatively with the site and corporate business teams to achieve targets.

G.3.6 Energy Efficiency Measures

A list and description of the various energy efficiency measures implemented on site is given in Attachment G.2.

For

insp

ectio

n pur

pose

s only

.

Conse

nt of

copy

right

owne

r req

uired

for a

ny ot

her u

se.

EPA Export 25-07-2013:20:16:22

62

SECTION H REMEDIATION, DECOMMISSIONING, RESTORATION & AFTERCARE

Describe the existing or proposed measures to minimise the impact on the environment after the activity or any part of the activity ceases operation, including provision for post-closure care of any potentially polluting residuals. Supporting information should be included as Attachment No. H.

Answer H.1.0 General

The inclusion of conditions relating to the remediation, decommissioning, restoration and aftercare of sites is a new element of the IPPC licensing process, so no conditions associated with these matters were included in the most recent IPPC Licence Register No. P0004-02. As such, a formal environmental liabilities risk assessment and a plan for the management of residual environmental liabilities have not been conducted hitherto. Nonetheless, in compliance with the existing licence, a regular schedule of groundwater monitoring and inspection of underground tank, underground pipeline and bund integrity is conducted, which minimises the potential of loss to ground or the aquatic environment. Results of these monitoring programmes are submitted to the Agency as part of each Annual Environmental Report. The Environmental Management Programme 2006 also includes objectives and targets for the protection of the quality of surface and ground waters. Recently issued IPPC Licences all have two major conditions, dealing with Decommissioning and Residuals Management, and Financial Charges and Provisions. It is anticipated that the new IPPC Licence, if granted, will include such conditions. The Environmental Protection Agency (EPA) has recently (July 2006) issued a set of Guidance Documents and Assessment Tools on Environmental Liabilities Risk Assessment and Residuals Management Plans incorporating Financial Provision Assessment for use in preparing this Section of the IPPC Licence Application. The methodology incorporates three elements:

1. Residuals Management Plan (known liabilities); 2. Environmental Liabilities Risk Assessment (unknown liabilities); and 3. Financial Provisions (appropriate and sufficient indemnity).

An Initial Screening and Operational Risk Assessment will be performed on the facility to establish whether it is a low, medium or high risk facility. The EPA Guidance Documents give direction in how to complete the three elements depending on the classification.

The EPA guidance will be followed during the completion of these elements. Details of the risk assessments and Residual Management Plan will be forwarded to the Agency as per the anticipated licence conditions. Appropriate financial provisions to cover the anticipated cost any known or unknown environmental liabilities will be put in place and confirmation thereof forwarded to the Agency.

For

insp

ectio

n pur

pose

s only

.

Conse

nt of

copy

right

owne

r req

uired

for a

ny ot

her u

se.

EPA Export 25-07-2013:20:16:22

63

SECTION I STATUTORY REQUIREMENTS 1. The applicant should provide the following information:

(i) Indicate how the requirements of Section 83(5)(a)(i) to (iv) of the EPA Acts 1992 and 2003 shall be met, having regard, where appropriate, to any relevant specification issued by the Agency under section 5 (3) of the Act and the reasons for the selection of the arrangements proposed.

I.1.1 Section 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”.

GSK does not seek any increase in mass emissions above those already contained in the existing IPC licence, nor any new higher concentrations of emissions. The existing emissions do not result in any breach of air quality standards or emission limits under the Air Pollution Act of 1987. No new emission point to air is proposed under the licence review application.

I.1.2 Section 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”.

No new emission to sewer is proposed under this application for licence review. The existing emissions do not result in any breach of water quality standard or emission limit under section 26 of the Local Government (Water Pollution) Act 1977.

I.1.3 Section 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 Activity has not in the past breached any relevant standards applicable under the European Communities Act. As no new emissions are proposed, no likelihood of such breach is anticipated.

I.1.4 Section 83 (5)a (iv)

“Any noise from the activity will comply with, or will not result in the contravention of any regulations under section 106”.

For

insp

ectio

n pur

pose

s only

.

Conse

nt of

copy

right

owne

r req

uired

for a

ny ot

her u

se.

EPA Export 25-07-2013:20:16:22

64

Changes in the operation of the plant will not result in any significant increase in noise emissions. No significant new noise sources are proposed.

I.1.5 Section 83 (5)a (v)

“Any emissions from the activity will not cause significant environmental pollution”.

Analysis of environmental impacts carried out previously and previous modelling of emissions from the activity has demonstrated that no significant pollution is likely to occur. As no new emission sources are proposed there is no anticipated source of significant environmental pollution. I.1.6 Section 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”.

GSK will continue to minimise waste generation on site and, where not possible to reduce at source, will aim to recover or employ end-of-pipe treatment to BAT standards. All waste will be managed as per the site Total Waste Management Programme. I.1.7 Section 83 (5)a (viii)

“energy will be used efficiently in the carrying on of the activity”

GSK has been recognized as a leader in the efficient use of energy and will continue to utilise good energy management practices in the operation of the activity as proposed.

For further details on the company’s efforts to increase energy efficiency, refer to Section G of this Review Licence Application.

I.1.8 Section 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”

The management of accidents and control of risk associated with the activity has been described in the previous applications and Environmental Impact Assessments. As part of GSK’s ongoing risk control measures, the aspects related to control of hazards are subject to ongoing review. I.1.9 Section 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”.

For

insp

ectio

n pur

pose

s only

.

Conse

nt of

copy

right

owne

r req

uired

for a

ny ot

her u

se.

EPA Export 25-07-2013:20:16:22

65

Please refer to Section H of this Review Licence Application for a discussion on the plan for the management of residuals in the event of definitive cessation of the activity.

I.2 Indicate whether or not the activity is carried out on, or may be carried out on,

or is located such that it is liable to have an adverse effect on - (a) a site placed on a list in accordance with Chapter 1 of S.I. 94 of 1997, or (b) a site where consultation has been initiated in accordance with Article 5 of the EU Habitats Directive (92/43/EEC)

The nearest candidate Special Protected Area (cSPA) is at Loughbeg, code 001066, which surrounds the site on all sides. This is part of the greater Cork Harbour, a designated Special Protection Area (SPA), code 004030. The only emissions from the site to Loughbeg are the licensed discharges of clean surface water (SW2) and treated effluent from the biological treatment plant (SW01), which are monitored and controlled. An ecological review of Loughbeg was carried out in 1997 and a copy is appended to the Environmental Impact Study of 1998 previously submitted to the Agency. No additional emissions to Loughbeg are envisaged. No impact whatsoever is envisaged from the activity. Monkstown Creek, 3 Km northwest of the facility, is a proposed National Heritage Area (pNHA), code 001979, onto which no impact is envisaged from the activity. I.3 Indicate whether or not the activity is liable to have an adverse effect on water

quality in light of S.I. No. 258 of 1998 (Local Government (Water Pollution) Act, 1977 (Water Quality Standards for Phosphorus) Regulations, 1998).

The activities undertaken at the facility produce levels of phosphorous well below the IPC licence limit. The activity therefore does not have an adverse effect on water quality in the light of S.I. No. 258 of 1998. I.4 Indicate whether any of the substances specified in the Schedule of the EPA

(Licensing) (Amendment) 2004 are discharged by the activity to the relevant medium.

Substances listed in the Schedule to the above mentioned regulations may be emitted as follows: I.4.1 AIR Substance Status (1) Sulphur dioxide and other sulphur compounds Emissions from Incinerators

which are well below IPC Licence limits

(2) Oxides of nitrogen and other nitrogen compounds Emissions from Incinerators which are well below IPC Licence limits

(3) Carbon monoxide Emissions from Incinerators which are well below IPC Licence limits

(4) Volatile organic compounds Very low emissions from emergency scrubber which operates ~ 1% of year

(5) Metals and their compounds None

For

insp

ectio

n pur

pose

s only

.

Conse

nt of

copy

right

owne

r req

uired

for a

ny ot

her u

se.

EPA Export 25-07-2013:20:16:22

66

(6) Dust Emissions from Incinerators which are well below IPC Licence limits

(7) Adbestos (suspended particulates, fibres) None (8) Chlorine and its compounds Emissions of HCl from

Incinerators which are well below IPC Licence limits

(9) Fluorine and its compounds Emissions of HF from Incinerators which are well below IPC Licence limits

(10) Arsenic and its compounds None (11) Cyanides None (12) Substances and preparations which have been proved to possess carcinogenic or mutagenic properties or properties which may affect reproduction via the air

None

(13) Polychlorinated dibenzodioxins and polychlorinated dibenzofurans

Emissions PCDD/PCDF from Incinerators which are well below IPC Licence limits of 0.1 ng/m3

I.4.2 WATER – (Emission to sewer) Substance Status (1) Organohalogen compounds and substances which may form such compounds in the aquatic environment

None emitted

(2) Organophosphorus compounds None emitted (3) Organotin compounds None emitted (4) Substances and preparations which have been proved to possess carcinogenic or mutagenic properties or properties which may affect reproduction in or via the aquatic environment

None emitted

(5) Persistent hydrocarbons and persistent and bio-accumulable organic toxic substances

None emitted. Bioassays have shown Toxic Units < 3.

(6) Cyanides None emitted (7) Metals and their compounds See discussion below (8) Arsenic and its compounds None emitted (9) Biocides and plant health products None emitted (10) Materials in suspension Levels of suspended

solids well below licence limit.

(11) Substances which contribute to eutrophication (in particular, nitrates and phosphates)

Nitrates and Phosphates are well below the Licence limit

(12) Substances which have an unfavourable influence on the oxygen balance (and can be measured using parameters such as BOD, COD, etc.).

BOD and COD of treated effluent are well within the licence limits

(7) Metals and their compounds

For

insp

ectio

n pur

pose

s only

.

Conse

nt of

copy

right

owne

r req

uired

for a

ny ot

her u

se.

EPA Export 25-07-2013:20:16:22

67

Emissions of metals to waters from the site are generally compliant with the IPC Licence. However, chromium concentrations in the treated waste water exceed the BAT limit for chromium specified in BREF Waste Water and Waste Gas document. Table I.4.2.1 BAT versus GSK WWTP performance (Metals) Metal Minimum Maximum Average BAT Comment Mercury 0.001 0.005 0.002 0.05 mg/L No

exceedences Lead 0.01 0.10 0.07 0.5 mg/L No

exceedences Total Chromium

0.04 2.07 0.77 0.5 mg/L Exceedence

Cadmium 0.0095 0.01 0.0099 0.05 mg/L No exceedences

Zinc 0.01 0.15 0.067 0.5 mg/L No exceedences

Copper 0.01 0.04 0.025 0.5 mg/L No exceedences

The increase in chromium concentrations originates from the refractory brick installed as a high resistance lining in the firebox of Incinerator number 1 in 2002. This brick contains chromium trioxide and chromium leaches out and appears in the scrubber waste waters. To reduce the chromium concentration below the BAT limit, two approaches have been considered:

• Removal of chromium by precipitation from solution. This has been evaluated in the laboratory and removal of chromium to well below the 0.5 mg/L concentration was demonstrated. Removal of chromium by precipitation in the laboratory poses no problem but it is felt that removal on plant would be fraught with difficulties.

• Replacement of the chromium-containing refractory brick by a non chromium-containing material. GSK has contacted the incinerator vendor on this; the vendor, Caloric, is trying to source a refractory which has high resistance to attack and has no chromium content.

I.5 State whether the activity is an establishment to which the EC (Control of

Major Accident Hazards involving Dangerous Substances) Regulations, 2000 (S.I. No. 476 of 2000) apply.

The above Regulations apply to GSK Cork, which is designated a “top tier” Seveso II site. For further information on the site’s emergency planning and response provisions, please refer to Section F.1 above. I.6 Fit and Proper Person

The PoE Act in Section 83(5)(xi) specifies that the Agency shall not grant a licence unless it is satisfied that the applicant or licensee or transferee as the case may be is a fit and proper person. Section 84(4) of the PoE Act specifies the information required to enable a determination to be made by the Agency.

For

insp

ectio

n pur

pose

s only

.

Conse

nt of

copy

right

owne

r req

uired

for a

ny ot

her u

se.

EPA Export 25-07-2013:20:16:22

68

I.6.1 Indicate whether the applicant or other relevant person has been convicted

under the PoE Act, the Waste Management Act 1996, the Local Government (Water Pollution) Acts 1977 and 1990 or the Air Pollution Act 1987.

Neither the applicant nor other relevant persons (employees of the applicant or directors, managers, secretaries or other similar officers of the applicant) have been convicted of an offence under the EPA Acts 1992 and 2003, the Waste Management Acts 1996 and 2003, the Local Government (Water Pollution) Acts 1977 and 1990 or the Air Pollution Act 1987. I.6.2 Provide details of the applicant’s technical knowledge and/or qualifications,

along with that of other relevant employees. A competent and professional workforce operates the large, modern and self-contained plant with a proven track record in developing processes and delivering products to the highest regulatory standards. The company employs 540 people of whom 54% have third level qualifications including PhD, Masters, Degree, Diploma or certificate qualifications. The organisation of responsibilities for Environmental Management on site is shown in Figure I.1 below.

Figure I.1 Environmental Staff Organisational Chart The EHS Team Leader qualifies as a “Fit and Proper Person” under the terms of Section 84(4) of the PoE Act. He is responsible for all aspects of environment, health,

EHS Team Leader

Environmental RegulatoryGroup Leader

(ERGL)

Environmental OperationsTechnical Leader

(EOTL)

Environmental Chemist

Environmental Specialist

12 x ShiftOperators

(3 per shift)

Environmental

Chemist

Environmental

Analytical Chemist

Site Director

Contract Engineer

For

insp

ectio

n pur

pose

s only

.

Conse

nt of

copy

right

owne

r req

uired

for a

ny ot

her u

se.

EPA Export 25-07-2013:20:16:22

69

safety and security on the site. He holds a BSc (Hons) in Chemistry and an MSc (Hons) in Occupational Hygiene and Ergonomics. He has worked in a number of industrial, pharmaceutical and medical centres of excellence and has over 10 years of experience in the environmental, health and safety area. The Environmental Regulatory Group Leader holds a first class honours degree in Chemistry and has undergone various training courses in environmental topics. He has worked for 36 years in the Chemical Industry and has gained an in-depth knowledge of the workings of Chemical Plant, Chemical Laboratory, Waste Water Treatment Plant, Incinerator Operation, Solvent Recovery, Environmental Legislation, Site Permitting, Waste Minimisation, and Environmental Impact Studies. He is a member of IBEC’s Environmental Working Party. The Environmental Operations Group Leader has an Honours Degree in Chemistry and a Postgraduate qualification in Chemical Engineering. He has 18 years experience in the Chemical Industry in Production, Quality Control and Environmental Operations. The Environmental Chemist has a Diploma in Chemical Technology. He has worked in GSK’s Environmental Department for 15 years and has considerable experience in Waste Water Treatment Plant Operation, Solvent Recovery Plant Operation, and Waste Disposal. The Environmental Supervisor has worked in the Environmental Department for 30 years and has extensive experience in operation of the hazardous waste incinerators, waste water treatment plant and solvent recovery plant. The two Environmental Analytical Chemists have degrees and extensive experience in Quality Control and Environmental Control laboratories and operation of WWT Pilot plant. I.6.3 Provide information to show that the person is likely to be in a position to meet

any financial commitments or liabilities that may have been or will be entered into or incurred in carrying on the activity to which the application relates or in consequence of ceasing to carry out that activity.

SmithKline Beecham (Cork) Ltd., located at Currabinny, Carrigaline, County Cork, is a manufacturing facility of GlaxoSmithKline Corporation which is headquartered in London. The Currabinny facility, with an annual site turnover of €300 - €700 million, contributes an estimated €120 million annually to the Irish economy by way of wages, salaries, payments to local suppliers and contractors, and disbursements to the Irish exchequer. The site is committed to full compliance with all applicable legal requirements to which the organisation subscribes. This includes compliance with the site’s current IPC licence and also the site’s IPPC licence if issued. Section H of this review application outlines the measures that will be taken to assess the risk of the potential environmental liabilities associated with carrying on the activity to which the application relates or in consequence of ceasing to carry out that activity. A copy of the company’s public liability insurance policy is included in Attachment F.1. 1.7 Obligations as set out in the IPPC Directive (96/61/EC)

For

insp

ectio

n pur

pose

s only

.

Conse

nt of

copy

right

owne

r req

uired

for a

ny ot

her u

se.

EPA Export 25-07-2013:20:16:22

70

The Agency shall ensure that installations are operated in accordance with basic obligations as set out in Article 3 of the IPPC Directive (96/61/EC). Article 6 of the IPPC Directive (96/61/EC) specifies that a description of the measures in place to ensure compliance with the general principles of the basic obligations of the operator shall be part of the application. Describe the measures proposed or in place to ensure that:

(a) The best available techniques are or will be used to prevent or eliminate or, where that is not practicable, generally reduce an emission from the activity;

The GSK plant is constructed and operated in such a way that all emissions are reduced or eliminated to the lowest level practicable. A detailed account of how this is achieved can be referenced in the Tables in Attachment D.6.

(b) no significant pollution is caused; Continuous monitoring of the incineration operation on site, together with waste water treatment plant testing, surface water and groundwater monitoring, demonstrates a very high compliance level with the IPC Licence requirements which imply no significant pollution.

(c) waste production is avoided in accordance with Council Directive 75/442/EEC of 15 July 1975 on waste; where waste is produced, it is recovered or, where that is technically and economically impossible, it is disposed of while avoiding or reducing any impact on the environment;

GSK will continue to minimise waste generation on site and where not possible to reduce at source will aim to recover or employ end-of-pipe treatment to BAT standards.

(d) energy is used efficiently;

Minimisation of energy usage on site is of prime importance. Details of energy usage and reduction of energy, e.g. waste heat recovery from Incinerator Number 3, are discussed in Attachment G.

(e) the necessary measures are taken to prevent accidents and limit their consequences;

It is the policy of GSK to be fully prepared and have suitable mitigation measures in place for any foreseen emergency such as flammable liquid releases, flammable gas emissions, fire, toxic gas emissions, and other potential hazards associated with its operations.

For

insp

ectio

n pur

pose

s only

.

Conse

nt of

copy

right

owne

r req

uired

for a

ny ot

her u

se.

EPA Export 25-07-2013:20:16:22

71

GSK has a Site Emergency Procedure in place that details the emergency response procedures for the facility. This sets out the action to be taken by the Emergency Response Team and all employees. The purpose of the procedure is to provide intervention measures to protect people, the community and the environment. Please see Section F for further details.

(f) the necessary measures are taken upon definitive cessation of activities to avoid any pollution risk and return the site of operation to a satisfactory state.

GSK will comply fully with the necessity for carrying out the following:

• Environmental Liability Risk Assessment (ELRA) • Residuals Management Plan (RMP) • Closure Plans • Environmental Risk Reduction • Financial Provision.

Please refer to Section H of this application for details.

Supporting information should be included as Attachment No I with cross-references to where the relevant information can be found in other parts of this review application.

For

insp

ectio

n pur

pose

s only

.

Conse

nt of

copy

right

owne

r req

uired

for a

ny ot

her u

se.

EPA Export 25-07-2013:20:16:22

72

For

insp

ectio

n pur

pose

s only

.

Conse

nt of

copy

right

owne

r req

uired

for a

ny ot

her u

se.

EPA Export 25-07-2013:20:16:22