integrated pollution control final licence · noise sensitive location any dwelling house, hotel or...

Headquarters, ArdcavanWexford, Ireland

INTEGRATED POLLUTION CONTROL

FINAL LICENCE

Licence Register Number: 118

Licensee: Rhone Poulenc Rorer PharmaceuticalsIrl. Ltd.

Location of Activity: Lisbunny Industrial Estate

Nenagh

Environmental Protection Agency IPC Licence Reg. No 118

Co. Tipperary


Table of Contents

Page No.

Glossary ........................................................................................................................... 1

Condition 1 Scope.......................................................................................................................... 3

Condition 2 Management of the Activity ........................................................................................ 3

Condition 3 Interpretation............................................................................................................... 5

Condition 4 Notification.................................................................................................................. 6

Condition 5 Emissions to Atmosphere........................................................................................... 7

Condition 6 Emissions to Sewer .................................................................................................... 8

Condition 7 Waste Management ................................................................................................... 9

Condition 8 Noise ........................................................................................................................ 10

Condition 9 Non-Process Water .................................................................................................. 11

Condition 10 Monitoring............................................................................................................... 13

Condition 11 Recording and Reporting to Agency....................................................................... 14

Condition 12 Emergency Response ............................................................................................ 15

Condition 13 Financial Provisions................................................................................................ 15

Schedule 1(i) Emissions to Atmosphere..................................................................................... 16

Schedule 1(ii) Emissions to Atmosphere: Abatement/Treatment Control................................... 19

Schedule 1(iii) Monitoring of Emissions to Atmosphere.............................................................. 20

Schedule 2(i) Emissions to Sewer .............................................................................................. 23

Schedule 2(ii) Effluent Treatment Control................................................................................... 23

Schedule 2(iii) Monitoring of Emissions to Sewer....................................................................... 24

Schedule 3(i) Hazardous Wastes for Disposal/Recovery........................................................... 25

Schedule 3(ii) Other Wastes for Disposal/Recovery .................................................................. 26

Schedule 4 (i) Surface Water Discharge Monitoring................................................................... 26

Schedule 5(i) Groundwater Monitoring ....................................................................................... 27

Schedule 6(i) Recording and Reporting to the Agency............................................................... 28


Glossary of Terms

The Agency Environmental Protection Agency.

The Licensee Rhone Poulenc Rorer Pharmaceuticals Irl. Ltd., Lisbunny IndustrialEstate, Nenagh, Co. Tipperary.

Local Authority Nenagh Urban District Council.

Sewage Undertaker Shannon Free Airport Development Company Limited.

SFADCo Shannon Free Airport Development Company Limited.

IPC Integrated Pollution Control.

EMP Environmental Management Programme.

PER Pollution Emission Register.

AER Annual Environmental Report.

dB(A) Decibels (A weighted).

K Kelvin.

kPa kilo Pascals.

Leq Equivalent continuous sound level.

BOD 5 day Biochemical Oxygen Demand.

COD Chemical Oxygen Demand.

Day 0800 hrs to 2200 hrs.

Night 2200 hrs to 0800 hrs.

Daily During all days of plant operation, and in the case of emissions, whenemissions are taking place; with no more than 1 measurement on anyone day.

Weekly During all weeks of plant operation, and in the case of emissions,when emissions are taking place; with no more than one measurementin any one week.

Monthly At least 12 times per year at approximately monthly intervals.

Quarterly All or part of a period of three consecutive months beginning on thefirst day of January, April, July or October.

Bi-annually All or part of a period of six consecutive months.

Annually All or part of a period of twelve consecutive months.


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List I As listed in the EC Directives 76/464/EEC and 80/68/EEC andamendments.

List II As listed in the EC Directives 76/464/EEC and 80/68/EEC andamendments.

Waste disposal operation Means any of the operations included in the Third Schedule to theWaste Management Act 1996.

Waste recovery operation Means any of the operations included in the Fourth Schedule to theWaste Management Act 1996.

Noise sensitive location Any dwelling house, hotel or hostel, health building, educationalestablishment, place of worship or entertainment, or any other facilityor area of high amenity which for its proper enjoyment requires theabsence of noise at nuisance levels.

EWC European Waste Catalogue (94/3/EEC, see also Agency GuidanceNote on the EWC)

GC Gas Chromatography

GC/MS Gas Chromatography/ Mass Spectroscopy

HPLC High Pressure Liquid Chromatography

TA Luft Technical Instructions on Air Quality Control - TA Luft in accordancewith art. 48 of the Federal Immission Control Law (BImSchG) dated15 March 1974 (BGBI. I p.721). Federal Ministry for Environment,Bonn 1986.

Mass Flow Threshold A mass flow rate, above which, a concentration limit applies. The rateis usually expressed in kilograms per hour (e.g. at mass flow rates > 2kg/hr).

Mass Flow Limit An Emission Limit Value which is expressed as the maximum mass ofa substance which can be emitted per unit time. The limit is usuallyexpressed in kilograms per hour (kg/hr).


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Conditions

Scope

1.1 The activity shall be controlled, operated, and maintained and emissions shall take placeas set out in this Integrated Pollution Control (IPC) licence. All programmes required tobe carried out under the terms of this licence, become part of this licence.

1.2 No alteration to, or reconstruction in respect of, the activity or any part thereof whichwould, or is likely to, result in a material change or increase in :

1.2.1 The nature or quantity of any emission,

1.2.2 The abatement/treatment or recovery systems,

1.2.3 The range of processes to be carried out,

1.2.4 The fuels, raw materials, intermediates, products or wastes generated,

or any changes in:

1.2.5 The site management and control with adverse environmental significance

shall be carried out or commenced without prior notice to, and without the prior writtenagreement of, the Agency.

1.3 This licence is for the purposes of IPC licensing only and nothing in this licence shall beconstrued as negating the licensees statutory obligations or requirements under anyother enactments or regulations.

1.4 Any reference in this licence to ‘site’ shall mean the plan area edged in red entitled‘Rhone Poulenc Rorer Site’ on the map extract from O.S. Sheet labelled ‘Tipperary 21/5’in the IPC licence application.

Reason: To clarify the scope of this licence.

Management of the Activity

2.1 The licensee shall establish and maintain an Environmental Management System(EMS) which shall fulfil the requirements of this licence. The EMS shall assess alloperations and review all practicable options for the use of cleaner technology, cleanerproduction and the reduction and minimisation of waste, and shall include as a minimumthose elements specified in the Conditions 2.2 to 2.9 below:

2.2 A schedule of Environmental Objectives and Targets

2.2.1 The licensee shall prepare a schedule of Environmental Objectives andTargets. The schedule shall include time frames for the achievement of settargets. The schedule shall address a five year period as a minimum. Theschedule shall be prepared to the satisfaction of the Agency and shall besubmitted to the Agency within four months of date of grant of this licence. Theschedule shall be reviewed annually and amendments thereto notified to theAgency for agreement as part of the AER (see also Condition 2.9).


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2.3 Environmental Management Programme (EMP)

2.3.1 The licensee shall, not later than six months from the date of grant of thislicence, establish and maintain an Environmental Management Programme,including a time schedule, for achieving objectives and targets. The EMP shallthereafter, form part of the AER and shall be agreed with the Agency prior toimplementation. It shall include:

(i) designation of responsibility for targets;

(ii) the means by which they may be achieved;

(iii) the time within which they may be achieved.

2.3.2 A report on the programme, including the success in meeting agreed targets,shall be prepared and submitted to the Agency as part of the AER. Such reportsshall be retained on-site for a period of not less than seven years and shall beavailable for inspection by authorised persons of the Agency.

2.4 Pollution Emission Register (PER)

2.4.1 The substances to be included in the PER shall be agreed with the Agency eachyear by reference to the list specified in the AER guidance note. The PER shallbe prepared in accordance with any relevant guidelines issued by the Agencyand shall be submitted as part of the AER.

2.4.2 The licensee shall, not later than six months from the date of grant of thislicence and thereafter as part of the AER, agree with the Agency the list ofsubstances to be included in the PER, and the methodology to be used in theirdetermination.

2.5 Documentation

2.5.1 The licensee shall establish and maintain an environmental managementdocumentation system which shall be to the satisfaction of the Agency.

2.5.2 The licensee shall issue a copy of this licence to all relevant personnel whoseduties relate to any condition of this licence.

2.6 Corrective Action

2.6.1 The licensee shall establish procedures to ensure that corrective action is takenshould the specified requirements of this licence not be fulfilled. Theresponsibility and authority for initiating further investigation and correctiveaction in the event of a reported non-conformity with this licence shall bedefined.

2.7 Awareness and Training

2.7.1 The licensee shall establish and maintain procedures for identifying trainingneeds, and for providing appropriate training, for all personnel whose work canhave a significant effect upon the environment. Appropriate records of trainingshall be maintained.

2.7.2 Personnel performing specifically assigned tasks shall be qualified on the basisof appropriate education, training and/or experience, as required.

2.8 Responsibilities


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2.8.1 The licensee shall ensure that a person in charge, as defined under the terms ofthe Environmental Protection Agency Act, 1992 shall be available on-site at alltimes when the activity is in operation. The person in charge shall also beavailable to meet with authorised persons of the Agency at all reasonable times.

2.9 Communications

2.9.1 The licensee shall put in place a programme to ensure that members of thepublic can obtain information concerning the environmental performance of thelicensee at all reasonable times. This programme shall be submitted foragreement to the Agency within six months of the date of grant of this licence.

2.9.2 The licensee shall submit to the Agency, eighteen months from the date of grantof this licence, and each calendar year thereafter, an AER which shall be to thesatisfaction of the Agency. This report shall include as a minimum theinformation specified in Schedule 6 (i) Recording & Reporting to the Agency andshall be prepared in accordance with any relevant guidelines issued by theAgency.

Reason: To make provision for management of the activity on a planned basis having regardto the desirability of ongoing assessment, recording and reporting of matters affectingthe environment.

Interpretation

3.1 Emission limit values for emissions to atmosphere in this licence shall be interpreted inthe following way:-

3.1.1 For Non-Continuous Monitoring:

(i) For any parameter where, due to sampling/analytical limitations, a 30minute sample is inappropriate, a suitable sampling period should beemployed and the value obtained therein shall not exceed the emissionlimit value.

(ii) For flow, no hourly or daily mean value, calculated on the basis ofappropriate spot readings, shall exceed the relevant limit value.

(iii) Mass flow thresholds refer to a rate of discharge expressed in units ofkg/hr, above which the concentration emission limit value applies. Massflow threshold rates shall be determined on the basis of a single 30 minutemeasurement (i.e. the concentration determined as a 30 minute averageshall be multiplied by an appropriate measurement of flow and the resultshall be expressed in units of kg/hr).

(iv) Mass flow limits shall be calculated on the basis of the concentration,determined as an average over the specified period, multiplied by anappropriate measurement of flow. No value, so determined, shall exceedthe mass flow limit value.

(v) For all other parameters, no 30 minute mean value shall exceed theemission limit value.

3.2 The concentration limits for emissions to atmosphere specified in this licence shall bebased on gas volumes under standard conditions of :-


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3.2.1 In the case of non-combustion gases:

(i) Temperature 273K, Pressure 101.3 kPa (no correction for oxygen or watercontent).

3.2.2 In the case of combustion gases:

(i) Temperature 273K, Pressure 101.3 kPa, dry gas; 3% oxygen for liquid andgas fuels; 6% oxygen for solid fuels.

3.3 Emission limit values for emissions to sewer in this licence shall be interpreted in thefollowing way:-

3.3.1 Continuous monitoring:

(i) No flow value shall exceed the specified limit.

(ii) No pH value shall deviate from the specified range.

3.3.2 Non-Continuous Monitoring:

(i) For parameters other than pH and flow, no 24 hour flow proportionatecomposite sample shall exceed the emission limit value.

(ii) For parameters other than pH and flow, no grab sample value shall exceed1.2 times the emission limit value.

3.4 Noise

3.4.1 Noise from the activity shall not give rise to sound pressure levels (Leq, 15minute) measured at noise sensitive locations which exceed the limit value(s) bymore than 2 dB(A).

Reason : To clarify the interpretation of emission limit values fixed under the licence.

Notification

4.1 The licensee shall notify the Agency by both telephone and facsimile, if available, to theAgency’s Headquarters in Wexford, or to such other Agency office as may be specifiedby the Agency, as soon as practicable after the occurrence of any of the following:

4.1.1 Any release to atmosphere from any potential emission point.

4.1.2 Any emission which does not comply with the requirements of this licence.

4.1.3 Any malfunction or breakdown of control equipment or monitoring equipment setout in;

Schedule 1(ii) Emissions to Atmosphere: Abatement/Treatment Control, and

Schedule 2(ii) Effluent Treatment Control

which is likely to lead to loss of control of the abatement system.

4.1.4 Any incident with the potential for environmental contamination of surface wateror groundwater, or posing an environmental threat to air or land, or requiring anemergency response by the Local Authority.


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The licensee shall include as part of the notification, date and time of the incident,details of the occurrence, and the steps taken to minimise the emissions and avoidrecurrence.

4.2 The licensee shall make a record of any incident as set out in Condition 4.1 above. Thenotification given to the Agency shall include details of the circumstances giving rise tothe incident and all actions taken to minimise the effect on the environment andminimise wastes generated.

4.3 A summary report of reported incidents shall be submitted to the Agency as part of theAER. The information contained in this report shall be prepared in accordance with anyrelevant guidelines issued by the Agency.

4.4 In the event of any incident, as set out in Condition 4.1.2 above which relates todischarges to sewer, having taken place, the licensee shall notify SFADCo as soon aspracticable, after such an incident.

4.5 In the case of any incident as set out in Condition 4.1.2 above which relates todischarges to water, the licensee shall notify the Shannon Regional Fisheries Board assoon as practicable after such an incident.

4.6 In the event of any incident, as set out in Condition 4.1.4 having taken place, thelicensee shall notify the Local Authority as soon as practicable, after such an incident.

Reason : To provide for the notification of incidents and update information on the activity.

Emissions to Atmosphere

5.1 No specified emission to the atmosphere shall exceed the emission limit value set out inSchedule 1(i) Emissions to Atmosphere, subject to Condition 3, of this licence. Thereshall be no other emission to the atmosphere of environmental significance.

5.2 All equipment, including backup equipment, specified in Schedule 1(ii) Emissions toAtmosphere: Abatement/Treatment Control of this licence shall be provided on-site. Alltreatment/abatement, control and monitoring equipment shall be calibrated andmaintained when in use.

5.3 Monitoring and analyses of each emission shall be carried out as specified in Schedule1(iii) Monitoring of Emissions to Atmosphere of this licence. A report on the results ofthis monitoring shall be submitted to the Agency quarterly.

5.4 A summary report of emissions to atmosphere shall be submitted to the Agency as partof the AER. The information contained in this report shall be prepared in accordancewith any relevant guidelines issued by the Agency.

5.5 Within six months of date of grant of this licence, the licensee shall ensure that emissionto atmosphere vent A3 shall extend a minimum height of 19.4m above ground level andshall have a diameter not exceeding 0.25m. A report on this alteration in stackdimensions shall be submitted to the Agency within seven months of date of grant of thislicence.

5.6 Boilers shall be operated so as to give a smoke colour less than or equal to shadenumber 1 on the Ringelmann chart except during periods of start up. Such start upperiods shall not exceed 30 minutes in any 24 hour period.


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5.7 The licensee shall ensure that all operations on-site shall be carried out in a mannersuch that air emissions and/or odours do not result in significant impairment of, orsignificant interference with amenities or the environment beyond the site boundary.

5.8 Within three months of the date of grant of this licence, all vents shall dischargevertically upwards without obstruction and a report on the removal of all vent obstructionshall be submitted to the Agency within four months of date of grant of this licence.

Reason: To provide for the protection of the environment by way of control, limitation,treatment and monitoring of emissions.

Emissions to Sewer

6.1 No specified emission to sewer shall exceed the emission limit values set out inSchedule 2(i) Emissions to Sewer subject to Condition 3 of this licence. There shall beno other emissions to sewer of environmental significance.

6.2 The equipment, including backup equipment, specified in Schedule 2(ii) EffluentTreatment Control of this licence, shall be provided on-site. All treatment/abatement,control and monitoring equipment shall be calibrated and maintained at all times when inuse.

6.3 Monitoring and analyses of each emission shall be carried out as specified in Schedule2(iii) Monitoring of Emissions to Sewer of this licence. A report on the results of thismonitoring shall be submitted to the Agency and SFADCo monthly.

6.4 A summary report of emissions to sewer shall be submitted to the Agency as part of theAER. The information contained in this report shall be prepared in accordance with anyrelevant guidelines issued by the Agency.

6.5 The acute toxicity of the undiluted final effluent to at least four aquatic species fromdifferent trophic levels shall be determined by standardised and internationally acceptedprocedures and carried out by a competent laboratory. The name of the laboratory andthe scope of testing to be undertaken shall be submitted, in writing, to the Agency, withinthree months of the date of grant of this licence. Once the testing laboratory and thescope of testing have been agreed by the Agency, the Agency shall decide when thistesting is to be carried out and copies of all reports shall be submitted by the testinglaboratory simultaneously to the Agency and the licensee.

6.6 Having identified the most sensitive species outlined in Condition 6.5, subsequentcompliance toxicity monitoring on the two most sensitive species shall be carried out bythe laboratory identified in Condition 6.5 as per Schedule 2(iii) Monitoring of Emissionsto Sewer. The Agency shall decide when this testing is to be carried out and copies of allreports shall be submitted by the testing laboratory simultaneously to the Agency andthe licensee.

6.7 The licensee shall at no time discharge or permit to be discharged into the sewer anyliquid matter or thing which is or may be liable to set or congeal at average sewertemperature or is capable of giving off any inflammable or explosive gas or any acid,alkali or other substance in sufficient concentration to cause corrosion to sewer pipes,penstock and sewer fittings or the general integrity of the sewer.


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6.8 No substance shall be present in such concentrations as would constitute a danger tosewer maintenance personnel, or sewer fabric or the liberation of by-products whichmay interfere with the operations of the Shannon Development Sewerage Systems.

6.9 The licensee shall not make any additional connections to the Shannon DevelopmentSewerage System without the prior written approval of the Agency and writtenagreement of SFADCo.

Reason: By way of control, limitation, treatment and monitoring of emissions to provide for theprotection of the environment.

Waste Management

7.1 No waste shall be disposed of on-site.

7.2 No on-site waste recovery operation may be employed without the written agreement ofthe Agency.

7.3 Disposal or recovery of waste shall take place only as specified in Schedule 3(i)Hazardous Wastes for Disposal/Recovery and Schedule 3(ii) Other Wastes forDisposal/Recovery of this licence and in accordance with the appropriate National andEuropean legislation and protocols. No other waste shall be recovered on-site ordisposed of /recovered off-site without prior notice to, and prior written agreement of, theAgency.

7.4 Waste sent off-site for recovery or disposal shall only be conveyed to a wastecontractor, as agreed by the Agency, and only transported from the site of the activity tothe site of recovery/disposal in a manner which will not adversely affect the environment.

7.5 A full record, which shall be open to inspection by authorised persons of the Agency atall times, shall be kept by the licensee on matters relating to the waste managementoperations and practices at this site. This record shall as a minimum contain details ofthe following:

7.5.1 The names of the agent and transporter of the waste.

7.5.2 The name of the persons responsible for the ultimate disposal/recovery of thewaste.

7.5.3 The ultimate destination of the waste.

7.5.4 Written confirmation of the acceptance and disposal/recovery of any hazardouswaste consignments sent off-site.

7.5.5 The tonnages and EWC Code for the waste materials listed in Schedule 3(i)Hazardous Wastes for Disposal/Recovery and Schedule 3(ii) Other Wastes forDisposal/Recovery, sent off-site for disposal/recovery.

7.5.6 Details of any rejected consignments.

A copy of this Waste Management record shall be submitted to the Agency as part ofthe AER for the site.

Reason: To provide for the disposal of waste and the protection of the environment.


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Noise

8.1 Activities on-site shall not give rise to noise levels off site, at noise sensitive locations,which exceed the following sound pressure limits (Leq,15 minute) subject to Condition 3:

8.1.1 Day: 55 dB(A)

8.1.2 Night: 45 dB(A)

8.2 There shall be no clearly audible tonal component or impulsive component in the noiseemission from the activity at any noise sensitive location.

8.3 For sources:

(i) NS1 - Dust Extraction Unit 5

(ii) NS2 - Dust Extraction Unit 6

(iii) NS4 - Dust Extraction Unit 10

(iv) NS5 - Truck Dryer Unit

(v) NS6 - Carrier Chillers

the licensee shall prepare a programme to reduce noise emissions. This must highlightspecific goals and a time scale, together with options for modification, upgrading orreplacement. The licensee shall submit the programme to the Agency within six monthsfrom the date of grant of this licence. A report on the implementation of this programmeshall be submitted to the Agency within nine months of the date of approval by theAgency of the programme.

8.4 The licensee shall carry out a noise survey of the site operations annually. The licenseeshall consult with the Agency on the timing, nature and extent of the survey and shalldevelop a survey programme to the satisfaction of the Agency. The survey programmeshall be submitted to the Agency in writing at least one month before the survey is to becarried out. A record of the survey results shall be available for inspection by anyauthorised persons of the Agency, at all reasonable times and a summary report of thisrecord shall be included as part of the AER.

Reason: To provide for the protection of the environment by control of noise.


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Non-Process Water

9.1 Surface water

9.1.1 No trade effluent shall be discharged to the surface water system.

9.1.2 The licensee shall monitor surface water discharges in accordance withSchedule 4(i) Surface Water Discharge Monitoring of this licence.

9.1.3 The licensee shall determine the normal levels of pH and COD foruncontaminated surface water and shall, within twelve months from the date ofgrant of this licence, submit proposals to the Agency for the setting of warningand action levels, and establish a response programme when such approvedaction levels are reached.

9.1.4 In the event that any analyses or observations made on the quality orappearance of surface water runoff should indicate that contamination hastaken place, the licensee shall

(i) carry out an immediate investigation to identify and isolate the source ofthe contamination,

(ii) put in place measures to prevent further contamination and to minimisethe effects of any contamination on the environment,

(iii) notify the Agency as soon as is practicable.

9.1.5 No substance shall be discharged in a manner, or at a concentration, whichfollowing initial dilution, causes tainting of fish, interferes with the normalpattern of fish migration or which accumulates in sediments or biologicaltissues to the detriment of fish, wildlife or their predators.

9.2 Firewater Retention.

9.2.1 The licensee shall carry out a risk assessment to determine if the activityshould have a fire-water retention facility. The licensee shall submit theassessment and a report to the Agency on the findings and recommendationsof the assessment within six months from the date of grant of this licence.

9.2.2 In the event that a significant risk exists for the release of contaminated fire-water, the licensee shall, based on the findings of the risk assessment,prepare and implement, with the agreement of the Agency, a suitable riskmanagement programme. The risk management programme shall be fullyimplemented within six months from date of notification by the Agency.

9.2.3 The licensee shall have regard to the Environmental Protection Agency DraftGuidance Note to Industry on the Requirements for Fire-Water RetentionFacilities when implementing Conditions 9.2.1 and 9.2.2 above.

9.3 Groundwater

9.3.1 The licensee shall maintain the groundwater abstraction well, labelled ‘Well’ onMap No.14.1 of the IPC licence application.

9.3.2 The groundwater monitoring well shall be sampled and analysed inaccordance with Schedule 5(i) Groundwater Monitoring of this licence. Areport of such results shall be submitted to the Agency on a bi-annual basisand a summary report shall be submitted to the Agency as part of the AER.


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9.3.3 The licensee shall within six months of grant of this licence carry out acomprehensive hydrogeological investigation of the site. The scope, detail andprogramme, including report structure and reporting schedule, for thisinvestigation must be agreed by the Agency prior to implementation. Anyrecommendations arising from a report or reports on this investigation must beimplemented within such a period to be agreed with the Agency.

9.3.4 Any additional groundwater monitoring boreholes required arising fromCondition 9.3.3 shall be constructed to a standard, and at locations, to beagreed with the Agency.

9.3.5 All groundwater monitoring points shall be included in the sites maintenanceprogramme.

9.3.6 The monthly volume of groundwater abstracted for process activities shall berecorded and a summary report shall be submitted to the Agency as part of theAER.

9.4 Facilities for the Protection of Groundwater and Surface Water

9.4.1 All storage tank and drum storage areas shall be rendered impervious to thematerials stored therein. All storage tank areas shall be bunded, either locallyor remotely, to a volume of 110% of the largest tank within each individualbunded area. Drum storage areas shall as a minimum be bunded to a volumeequal to 110% of the sum of the volumes of the largest ten drums likely to bestored therein.

9.4.2 Any contaminated water draining from bunded areas shall be diverted forcollection and disposal in a manner which will not adversely affect theenvironment. The Agency shall be notified for agreement of the proposedmeans of disposal.

9.4.3 The integrity and water tightness of all the bunding structures and theirresistance to penetration by water or other materials stored therein shall betested and demonstrated by the licensee to the satisfaction of the Agency andshall be reported to the Agency within six months from the date of grant of thislicence and at periods of every three years thereafter as part of the AER.

9.4.4 The loading and unloading of materials shall be carried out in designatedareas protected against spillage and leachate run-off. While awaiting disposal,all materials shall be collected and stored in designated areas protectedagainst spillage and leachate run-off.

9.4.5 The licensee shall ensure that the high level detection alarms on the processeffluent sumps are operational at all times.

9.4.6 The licensee shall undertake a programme of testing and inspection ofunderground tanks and pipelines to ensure that all underground effluent andfoul sewer pipes are tested within six months from the date of grant of thislicence and at periods of every three years thereafter as part of the AER.

9.4.7 The licensee shall have in storage an adequate supply of containment boomsand suitable absorbent material to contain and absorb any spillage.

Reason: To provide for the protection of surface waters and groundwaters.


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Monitoring

10.1 The licensee shall carry out such sampling, analyses, measurements, examinations,maintenance and calibrations as set out in Schedules:-

Schedule 1(ii) Emissions to Atmosphere: Abatement/Treatment Control

Schedule 1(iii) Monitoring of Emissions to Atmosphere


Schedule 2(iii) Monitoring of Emissions to Sewer

Schedule 4(i) Surface Water Discharge Monitoring

Schedule 5 (i) Groundwater Monitoring

of this licence.

10.2 Where the ability to measure a parameter is affected by mixing before emission, then,with prior written agreement from the Agency, the parameter may be assessed beforemixing takes place.

10.3 All automatic monitors and samplers shall be functioning at all times (except duringmaintenance and calibration) when the activity is being carried on unless alternativesampling or monitoring has been agreed in writing by the Agency for a limited period. Inthe event of the malfunction of any continuous monitor, the licensee shall contact theAgency as soon as practicable, and alternative sampling and monitoring facilities shallbe put in place. Prior written agreement for the use of alternative equipment, other thanin emergency situations, shall be obtained from the Agency.

10.4 Monitoring and analysis equipment shall be operated and maintained as necessary sothat monitoring accurately reflects the emission or discharge.

10.5 The frequency, methods and scope of monitoring, sampling and analyses, as set out inthis licence, may be amended with the written agreement of the Agency followingevaluation of test results.

10.6 The licensee shall install on all emission points such sampling points or equipment,including any data-logging or other electronic communication equipment, as may berequired by the Agency. All such equipment shall be consistent with the safe operationof all sampling and monitoring systems.

10.7 The licensee shall provide safe and permanent access to the following sampling andmonitoring points:

10.7.1 Final trade effluent as discharged from the site.

10.7.2 Emission to atmosphere sampling points.

10.7.3 Noise sources on-site.

10.7.4 Waste storage areas on-site.

10.7.5 Surface waters discharge.

10.7.6 On-site ground-water monitoring wells.

and safe access to any other sampling and monitoring points required by the Agency.


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10.8 The licensee shall, within three months of the date of grant of this licence, install in aprominent location on the site a wind sock, or other wind direction indicator, which shallbe visible from the public roadway outside the site.

Reason: To ensure compliance with the requirements of other conditions of this licence byprovision of a satisfactory system of measurement and monitoring of emissions.

Recording and Reporting to Agency

11.1 The licensee shall record all sampling, analyses, measurements, examinations,calibrations and maintenance carried out in accordance with the requirements of thislicence.

11.2 The licensee shall record all incidents which affect the normal operation of the activityand which may create an environmental risk.

11.3 The licensee shall record all complaints of an environmental nature related to theoperation of the activity. Each such record shall give details of the date and time of thecomplaint, the name of the complainant and give details of the nature of the complaint.A record shall also be kept of the response made in the case of each complaint. Thelicensee shall submit a report to the Agency, during the month following suchcomplaints, giving details of any complaints which arise. A summary of the number andnature of complaints received shall be included in the AER.

11.4 The format of all records required by this licence shall be to the satisfaction of theAgency. Records shall be retained on-site for a period of not less than seven years andshall be available for inspection by the Agency at all reasonable times.

11.5 Reports of all recording, sampling, analyses, measurements, examinations, calibrationsand maintenance as set out in Schedule 6(i) Recording and Reporting to the Agency ofthis licence, shall be submitted to the Agency Headquarters as specified in this licence.The format of these reports shall be to the satisfaction of the Agency. One original andthree copies shall be submitted as and when specified.

11.6 Provision shall also be made for the transfer of environmental information, in relation tothis licence, to the Agency’s computer system, as may be requested by the Agency.

11.7 All reports shall be certified accurate and representative by the licensee's Plant Manageror other senior officer designated by the Plant Manager.

11.8 All written procedures controlling operations affecting this licence shall be available on-site for inspection by the Agency at all reasonable times.

11.9 The frequency and scope of reporting, as set out in this licence, may be amended withthe written agreement of the Agency following evaluation of test results.

Reason: To provide for the collection and reporting of adequate information on the activity.


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Emergency Response

12.1 The licensee shall ensure that an Emergency Response Procedure is in place whichshall address any emergency situation which may originate on-site. This Procedureshall include provision for minimising the effects of any emergency on the environment.

Reason: To provide for the protection of the environment.

Financial Provisions

13.1 Agency Charges

13.1.1 The licensee shall pay to the Agency a minimum annual contribution of £11,546,or such greater sum as the Agency from time to time determines, towards thecost of monitoring the emissions as the Agency considers necessary for theperformance of its functions under the Environmental Protection Agency Act,1992. The licensee shall in 1998 and subsequent years, not later than January31 of each year, pay to the Agency this amount updated in accordance withchanges in the Consumer Price Index from the date of the licence to therenewal date. The updated amount shall be notified to the licensee by theAgency. For 1997, the licensee shall pay a pro rata amount from the date ofthis licence to December 31 next. This shall be paid to the Agency within onemonth of the grant of this licence.

Reason: To provide for adequate financing for monitoring and financial provisions formeasures to protect the environment.


Page 16 of 29

Schedule 1(i) Emissions to Atmosphere

Emission Point Reference No.: A20

Location : Beel Boiler

Volume to be emitted: Maximum in any one day : 62,400 m3

Maximum rate per hour : 2,600 m3

Minimum discharge height: 10 m above ground

Parameter Emission Limit Value (mg/m3)

Sulphur dioxide 1700

Nitrogen oxides (as NO2) 750

Carbon Monoxide (CO) 200

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Emission Point Reference No.: A21

Location : Chieftain Boiler

Volume to be emitted: Maximum in any one day : 45,600 m3

Maximum rate per hour : 1,900 m3

Minimum discharge height: 10 m above ground

Parameter Emission Limit Value (mg/m3)

Sulphur dioxide 1700

Nitrogen oxides (as NO2) 750

Carbon Monoxide (CO) 200

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Page 17 of 29

Emission Point Reference No.: A3 (Driam Coating Pan)

Location : Tablet Manufacturing Block

Volume to be emitted: Maximum rate per hour : 4,200m3

Minimum discharge height: 19.4m above ground (within 6 months of date of grant of this licence)Stack diameter: 0.25m (within 6 months of date of grant of this licence)

Parameter Emission Limit Value

Until December 31, 1998 From January 1, 1999 Note 1

TA Luft Class I Organics(including chloroform)

20mg/m3 (at mass flows >0.1kg/hr) 20mg/m3 (at mass flows >0.1kg/hr)

Ethanol

Methanol

18.9 kg/hr

15.0 kg/hr

---

---

Total Organics (as C) --- 150mg/m3 (at mass flows >3.0 kg/hr)

Note 1: The limit for Total Organics (as C) includes the limit for TA Luft Class I organic substances. The limits arebased on solvent usage for pharmaceutical finishing of <50 tonnes per annum.

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Emission Point Reference No.: A4 (Fluidised bed Dryer)



Minimum discharge height: 6.5 m above ground



Ethanol 7.2 kg/hr ---


Note 1: This limit is based on solvent usage for pharmaceutical finishing of <50 tonnes per annum.

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Page 18 of 29

Emission Point Reference No.: A22 (Pellegrinni Coating Pan)




Parameter Emission Limit Value Note 1

TA Luft Class I Organics (including chloroform) 20mg/m3 (at mass flows >0.1kg/hr)

Total Organics (as C) 150mg/m3 (at mass flows >3.0 kg/hr)

Note 1: The limit for Total Organics (as C) includes the limit for TA Luft Class I organic substances. The limitsare based on solvent usage for pharmaceutical finishing of <50 tonnes per annum.

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Emission Point Reference No.: A23 (Accelacota 48 Coating Pan)






TA Luft Class I Organics(including chloroform)

20mg/m3 (at mass flows >0.1kg/hr) 20mg/m3 (at mass flows >0.1kg/hr)

Ethanol 19.8 kg/hr ---


Note 1: The limit for Total Organics (as C) includes the limit for TA Luft Class I organic substances. The limits arebased on solvent usage for pharmaceutical finishing of <50 tonnes per annum.

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Page 19 of 29

Total Particulate Emissions to Atmosphere

Emission PointRef.

Source Emission Limit Value (mg/m3) for Total Particulates

Until December 31, 1998 From January 1, 1999

A3 Driam coating pan 5 1

A4 Fluidised bed drier S4 5 1

A5 Fluidised bed drier T61 5 1



A9 Truck Dryer 1 5 1

A10 Truck Dryer 2 5 1

A11 Coating solution preparation 5 1

A12 Dust Extraction Unit 1 5 1








A22 Pellegrinni coating pan 5 1

A23 Accelacota 48 coating pan 5 1

A24 Accelacota 150 coating pan 5 1

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Schedule 1(ii) Emissions to Atmosphere: Abatement/TreatmentControl

Emission Point Reference No’s.: A3, A4, A5, A6, A7, A12, A13, A14, A15, A16, A17, A18, A19,A24

Description of Treatment: Dust Removal

Monitoring :

Control Parameter Monitoring to be Carried Out Monitoring Equipment

Dust emissions Pressure drop across filter Manometer and alarm


Page 20 of 29

Equipment:

Control Parameter Equipment Backup equipment

Dust emissions Filter, manometer and alarm Spare filter elements

Air Flow Fan Spares

Filter cleaning Compressed air jet or mechanicalshaker

Spares

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Schedule 1(iii) Monitoring of Emissions to Atmosphere

Emission Point Reference No.: A20 (Beel Boiler)

A21 (Chieftain Boiler)

Parameter Monitoring Frequency Analysis Method/Technique

SOx Annually Flue gas analyser

NOx Annually Flue gas analyser

CO Annually Flue gas analyser

Particulates Annually Isokinetic/Gravimetric

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Emission Point Reference No.: A3 (Driam Coating Pan)

Parameter Monitoring FrequencyNote1 AnalysisMethod/TechniqueNote 2

Until December 31,1998

From January 1, 1999

Chloroform Quarterly Quarterly Adsorption & GC or GC/MS

Ethanol Quarterly --- Adsorption & GC or GC/MS

Methanol Quarterly --- Adsorption & GC or GC/MS

Total Organics (as C) --- Quarterly Adsorption & GC or GC/MS

Note 1: Monitoring should be undertaken at a time when maximum emissions are occurring and should represent theparticular emissions occurring at that time.

Note 2: Or an equivalent method acceptable to the Agency.

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Page 21 of 29

Emission Point Reference No.: A4 (Fluidised Bed Dryer)



From January 1,1999





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Emission Point Reference No.: A22 (Pellegrinni Coating Pan)

Parameter Monitoring FrequencyNote 1 Analysis Method/TechniqueNote 2

Chloroform Quarterly Adsorption & GC or GC/MS

Total Organics (as C) Quarterly Adsorption & GC or GC/MS



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Emission Point Reference No.: A23 (Accelacota 48 Coating Pan)



From January 1,1999

Chloroform Quarterly Quarterly Adsorption & GC or GC/MS





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Page 22 of 29

Emission Point Reference No.: A8 (Solvent Dispensary)

A11(Coating Solution Preparation)

Parameter Monitoring FrequencyNote 1 Analysis Method/TechniqueNote 2

Chloroform Annually Adsorption & GC or GC/MS

Methanol Annually Adsorption & GC or GC/MS

Ethanol Annually Adsorption & GC or GC/MS



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Emission Point Reference No’s.: A3, A4, A5, A6, A7, A9, A10, A11, A12, A13, A14, A15, A16,A17, A18, A19, A22, A23, A24

Parameter Monitoring Frequency Analysis Method/Technique

Total Particulates Bi-annually Gravimetric

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Page 23 of 29

Schedule 2(i) Emissions to Sewer

Emission Point Reference No.: SE1 (Effluent Monitoring Point on Map No. 14.1 of IPC licenceapplication)

Name of Receiving Sewer: SFADCo Drain

Location: Lisbunny Industrial Estate

Volume to be emitted: Maximum in any one day : 290 m3

Maximum rate per hour : 18 m3


pH 6-9

mg/l

BOD 300

COD 450

Suspended Solids 600

Oils, Fats and Greases 15

Total Phosphorus (as P) 175

Chloride 1000

Aluminium 15

Detergents 1.0

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Emission Point Reference No.: SE1

Monitoring :

Monitoring to be Carried Out Monitoring Frequency Monitoring Equipment/Method

Level Continuous High level liquid alarm

Equipment:

Control Parameter Equipment Backup equipment

Effluent Transfer (Level) Sump pumps Standby pumps and spares held on site

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Page 24 of 29

Schedule 2(iii) Monitoring of Emissions to Sewer

Emission Point Reference No.: SE1

Parameter Monitoring Frequency Analysis Method/TechniqueNote 1

Flow Continuous On-line flow meter with recorder

Temperature Continuous On-line temperature probe with recorder

pH Continuous pH electrode/meter and recorder

Conductivity Continuous Conductivity probeNote 2

Biochemical Oxygen Demand Monthly (24 hr flow proportionalcomposite)

Standard Methods Note 3

Chemical Oxygen Demand Monthly (24 hr flow proportionalcomposite)


Suspended Solids Monthly (24 hr flow proportionalcomposite)

Standard MethodsNote 3

Oils, Fats and Grease Monthly (24 hr flow proportionalcomposite)


Total Phosphorus (as P) Monthly (24 hr flow proportionalcomposite)


Total Nitrogen (as N) Monthly (24 hr flow proportionalcomposite)


Chloride Monthly (24 hr flow proportionalcomposite)


Magnesium Monthly (24 hr flow proportionalcomposite)


Aluminium Monthly (24 hr flow proportionalcomposite)


Calcium Monthly (24 hr flow proportionalcomposite)


Detergents Monthly (24 hr flow proportionalcomposite)


Pharmaceutical activesNote 4 Bi-annually (24 hr flowproportional composite)

HPLC

Organic solventsNote 5 Bi-annually (24 hr flowproportional composite)

GC/MS

ToxicityNote 6 Bi-annually (24 hr flowproportional composite)

To be agreed with the Agency


Note 2: Within three months of date of grant of this licence.

Note 3: “Standard Methods for the Examination of Water and Wastewater”, (prepared and published jointly byA.P.H.A., A.W.W.A & W.E.F) 19th Ed. 1995, American Public Health Association, 1015 Fifteenth Street, N.W.,Washington DC 20005, USA.

Note 4: This analysis should include those active ingredients in use in the process.

Note 5: Screening for priority pollutant list substances (such as CLP 40, US EPA volatile and or semi-volatile). Thisanalysis shall include those organic solvents in use in the process.

Note 6: The number of toxic units (TU) = 100/ x hour EC/LC50 in percentage vol/vol so that higher TU values reflectgreater levels of toxicity. For test regimes where species death is not easily detected, immobilisation isconsidered equivalent to death.

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Page 25 of 29

Schedule 3(i) Hazardous Wastes for Disposal/Recovery

Waste Materials FurtherTreatment on-

site

On-site recovery,reuse or recycling Note

1

Method of off-sitedisposal/recovery Note 2

Waste Oils None None Agreed hazardous waste recoverycontractor

Waste solvents None None Agreed hazardous waste disposalcontractor

Waste nitrol ointment None None Agreed hazardous waste disposalcontractor

Other waste product,intermediate product, dust anddust filters

None None Agreed hazardous waste disposalcontractorNote 3

Microbiological wasteNote 4 Sterilisation

None

None

None

Refer to Schedule 3(ii)

Agreed hazardous waste disposalcontractorNote 3

Hazardous contaminatedpackaging material, paper, clothsand protective clothing

None None Agreed hazardous wasterecovery/disposal contractorNote 3

Ion exchange resin None None Agreed hazardous waste disposalcontractorNote 3

Spent fluorescent tubes None None Agreed hazardous wastedisposal/recovery contractorNote 3

Plastic, fibre and steel drumscontaining hazardous residuesNote

5

Decontamination

None

Re-use where possible

None

Refer to Schedule 3(ii)

Agreed hazardous wasterecovery/disposal contractorNote 3

OtherNote 6

Note 1: The licensee may reuse, recycle or recover waste subject to the prior written agreement of the Agency.

Note 2: Any variation from those contractors named in the IPC Licence application, or subsequent agreements, musthave the prior written agreement of the Agency.

Note 3: Prior to disposal/recovery of these wastes, the licensee must submit to the Agency, for agreement, details ofthe hazardous waste disposal/recovery contractors to be used.

Note 4: Only microbiological waste which has been sterilised can be disposed off site to the Local Authority landfill,otherwise an agreed hazardous waste contractor shall be used.

Note 5: Prior to disposal or re-use, all drums must be decontaminated, otherwise an agreed hazardous wastecontractor must be used.

Note 6: No other waste shall be disposed of off-site without prior notice to, and prior written agreement of the Agency.

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Page 26 of 29

Schedule 3(ii) Other Wastes for Disposal/Recovery

Waste Materials Further Treatmenton-site

On-site recovery,reuse or recycling

Note 1

Method of off-site recovery/disposal Note 2

Office waste None None Agreed waste disposal contractor

Canteen waste None None Agreed waste disposal contractor

Wooden pallets None Re-use and recycle wherepossible

Agreed waste recovery/disposalcontractor

Construction debris None None Agreed waste disposal contractor

Non-hazardous packaging,paper, cloths and clothing

None Re-use and recycle wherepossible


Uncontaminated drums None Re-use and recycle wherepossible


Non-hazardousmicrobiological waste

None None Agreed waste disposal contractor

Other Note 3

Note 1: The licensee may reuse, recycle or recover waste subject to the prior written agreement of the Agency.

Note 2: Any variation from those contractors named in the IPC Licence application, or subsequent agreements, musthave the prior written agreement of the Agency

Note 3: No other waste shall be disposed of or recovered off-site without prior notice to, and prior written agreement ofthe Agency.

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Schedule 4 (i) Surface Water Discharge Monitoring

Emission Point Reference No.: SW1 (Storm Water Emission Point on Map No. 14.1 ofIPC licence application)


pH Weekly pH electrode/meter

COD Weekly Standard MethodsNote 2

Conductivity Weekly Conductivity probe

Visual Inspection Daily (When surface water is flowing) Sample and examine for colour and odour



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Page 27 of 29

Schedule 5(i) Groundwater Monitoring

Emission Point Reference No.: Groundwater abstraction well (labelled ‘Well’ on MapNo.14.1 of the IPC licence application)


pH Bi-annually pH electrode/meter

Conductivity Bi-annually Conductivity probe

COD Bi-annually Standard Methods Note 2

Major Anions Bi-annually Standard Methods Note 2

Major Cations Bi-annually Standard Methods Note 2

Heavy Metals Bi-annually Standard Methods Note 2

Total Coliforms Bi-annually Standard Methods Note 2

Faecal Coliforms Bi-annually Standard Methods Note 2

Organic SolventsNote 3 Bi-annually GC/MS

Note 1: or an equivalent method acceptable to the Agency.


Note 3: Screening for priority pollutant list substances (such as CLP 40, US EPA volatile and/or semi-volatile). Thisanalysis shall include those organic solvents in use in the process.

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Page 28 of 29

Schedule 6(i) Recording and Reporting to the Agency

Completed reports shall be submitted to:

The Environmental Protection AgencyHeadquartersArdcavanWexford

or Any other address as may be specified by the Agency

Reports are required to be forwarded as set out below:

Recurring Reports:

Report ReportingFrequency

Report Submission Date

Monitoring of emissions to sewer Monthly Ten days after end of the month being reported on.

Surface Water Monthly Ten days after end of the month being reported on.

Complaints (where these arise) Monthly Ten days after end of the month being reported on.

Monitoring of emissions to atmosphere Quarterly Ten days after end of the quarter being reported on.

Groundwater Quality Bi-annually June 1 and December 1 each year.

Noise survey - proposal Annually One month before survey is carried out.

Noise survey - report Annually Twelve months from the date of grant of licence.

Schedule of objectives and targets - proposal Annually Four months from the date of grant of licence; thereafter aspart of the AER.

Pollution emission register - proposal Annually Six months from the date of grant of licence; thereafter as partof the AER.

Environmental management - programmeproposal.

Annually Six months from the date of grant of licence; thereafter as partof the AER.

AER (AER) Annually Eighteen months from the date of grant of licence and eachyear thereafter.


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Annual Environmental Report Content Items to be Addressed in the EMP

Emissions to atmosphere summary

Emissions to sewer summary

Waste management report

Incidents summary

Complaints summary

Schedule of objectives and targets - proposal

Schedule of objectives and targets - report

Environmental management programme - proposal

Environmental management programme - report

Pollution emission register - proposal

Pollution emission register - report

List I & II substance reductions

Noise monitoring summary

Groundwater monitoring summary

Tank and pipeline testing and inspection report (every threeyears)

Bund integrity assessment (every three years)

The reduction of phosphorus load in the trade effluent

Reduction in the number of emission points to air

The elimination of carcinogens in use

Reduction in use of solvent based coatings

Reduction of fugitive emissions

See also Guidance Note for AER - Environmental ManagementProgramme Section

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Once-off Reports:

Report Report Submission Date

Effluent toxicity - scope Within three months of the date of grant of licence.

Removal of vent obstruction Within four months of the date of grant of licence.

Programme for public information. Within six months of the date of grant of licence.

Noise reduction programme - proposal Within six months of the date of grant of licence.

Fire-water retention study. Within six months of the date of grant of licence.

Hydrogeological assessment Within six months of the date of grant of licence.

Tank and pipeline testing and inspection report Within six months of the date of grant of licence.

Bund integrity assessment Within six months of the date of grant of licence.

Stack dimension alteration at A3 Within seven months of the date of grant of licence.

Noise reduction programme - report on implementation Within nine months of the date of approval.

Surface water COD/pH warning level proposal. Within twelve months of the date of grant of licence.

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integrated pollution control final licence · noise sensitive location any dwelling house, hotel or...

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