our ref: ozepaio · p ha rmac h em. the new company name is corden pharma limited, trading as...
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Licensing Section Environmental Protection Agency Johnstown Castle Estate, Co. Wexford
Corden Pharma Ltd t/a Corden PharmaChernChem Unit 4, O'Connell Commercial Park,
Little Island Co.Cork.
T: +353 (0) 21 497 8900
9th March 201 0
Our Ref: OZepaIO
Ref: Transfer IPPC Application, PO462-01
Dear Sir/Madam,
Attached please find 3 copies of IPPC licence Transfer application for transfer of Licence No: P0462- 01 from Johnson Matthey Pharmaceutical Materials Ireland Ltd to Corden Pharma Ltd t/a Corden P ha rmaC h em.
The new company name is Corden Pharma Limited, trading as Corden PharmaChem and the associated certificate of incorporation and registration of business name are included in the appropriate transfer application form sections.
This delivery includes 3 hard copies, an original and 2 copies, and application fee of €2000
If you have any further queries please contact the undersigned at 086-6794653
Yours Sincerely,
EH§ Manager 0866794653
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@Q>-o-n Transfer of Licence Application Form
m a I Environmental Protection Agency
An Ghniomhaireacht um Chaornhnu Comhshooil
Licensing
Transfer of a Licence Application Form
This document does notpurport to be and should not be considered a legal interpretation of the provisions and
requirements of the Waste Management Acts, I996 to 2008 /Environmental Protection Agency Acts 1992 to 2007.
Environmental Protection Agency P.O. Box 3000, Johnstown Castle, County Wexford
TcIephone: 053-91 60600 Fax: 053-91 60699
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I
Transfer of Licence Application Form
Not withstanding the provisions of Section 47 of the Waste Management Acts 1996 to 2008 or Section 94 of Environmental Protection Agency Acts 1992 to 2007 the following should be completed when applying to the Agency for the transfer of a
Waste or IPPC Licence.
Licence Register Number
Contact details for a contact person or
persons in relation to the application to
transfer.
Location of activity to which the licence
relates
Name address and contact details of current licence
holder
l------ Name address and contact details of
proposed transferee
When do the applicants want the
transfer to take effect ?
Classes /Nature of Activity
I
PO462-01
Mr. Sean Kenrick, EHS Manager, Corden Pharma Ltd (t/a Corden PharmaChem), Little Island, Co.Cork 021-4988900 086-6794653 [email protected]
4, OC Commercial Park, Little Island, Cork
Johnson Matthey Macfarlan Smith Limited 10 Wheatfield Rd Edinburgh EH11 2QA United Kingdom
Corden Pharma Ltd (t/a Corden PharmaChem), Little Island, Co.Cork
14fh Jan 2010
5.6 The manufacture of Pharmaceutical intermediates
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Transfei? of Licence Ayplicdion Form
Attachment A: Licence
Attachment B:
Attachment C: Fit and Proper
Person
Please provide as Attachment A (as per Section 94 (3) of the Protection of the Environment Acts 1992 to 2007) a copy of the licence you wish to transfer.
See Attachment A.1& A.2
Please provide as Attachment B the following as appropriate:
(a) (b) (c)
Certified Copy of Certificate of Incorporation Company's Number in Company's Registration Office and Particulars of Registered Office of the Company
Does the proposed transferee have a parent company? Ifso please provide details here. Does the proposed transferee have any subsidiaries involved in the industrial installation or waste facility management? If soplease give details here.
See Attachment B
The following information is required (please provide the information below or separately as Attachment C):
1. Indicate whether the applicant or other relevant person has been convicted under the PoE Act, the Waste Management Act 1996 to 2008, the Local Government (Water pollution) Acts 1977 and 1990 or the Air Pollution Act 1987.
2. Provide details of the applicant's technical knowledge and/or qualifications, along with that of other relevant employees (see details below).
3. Provide information to show that the person is likely to be in a position to meet any financial commitments 01
liabilities that may have been or will be entered into 01
incurred in carrying on the activity to which the applicatior relates or in consequence of ceasing to carry out thal activity .
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Attachment D: Liabilities,
requirements & obligations
Trans fer of Licence Application Fovrn
In relation to Question 2 above please give details here for each person who will or is likely to have responsibility for licensed activities, to include:
a) the names of all persons who are to provide the management and supervision of the activities authorised by the licence, in particular the name of the facility manager and any nominated deputies; details of the responsibilities for each individual named under a) above; and details of the relevant education, training and experience held by each of the persons nominated under a) above.
b)
c)
See Attachment C
Please provide a statement to show that the person to whom a licence is transferred has assumed and accepted all liabilities, requirements and obligations provided for in or arising under the licence, or revised licence, regardless of how and in respect of what period, including a period prior to the transfer of the licence or revised licence they may arise.
Corden Pharma Ltd are assured by current licence holder, Johnson Matthey Ltd that no liabilities exist. All requirements and obligations under the licence will be assumed by Corden Pharma Ltd.
See Attachment D- completed by Johnson Matthey
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Littachment E: Transferee
Licence details
Attachment F: Estimated
Expenditure & Financial Provtsions
Application Fee
Tmisfer of Licence Applicution Form
Has the proposed transferee, their parent company or any 'relevant person' had an application for a licence granted? Please provide ietails here or separately as Attachment E.
:orden Pharma Ltd (t/a Corden PharmaChem) has PO134-03, since 1996. This licence is currently ceased and plan in action to effect its ;mender in 20 10. 9 copy of PO134-03 is attached in Attachment E
Has the proposed transferee, their parent company or any 'relevant person' had an application for a licence rejected; had a licence revoked; been refused as a transferee for a licence? Please provide details here or separately as Attachment E.
No to all of the above.
Please provide, as attachment F, a plan showing the estimated expenditure for each phase of the activity/activities. The plan should include the likely costs of: (i) (ii) (iii) (iv)
Abatement Installation, Control & Monitoring Closure & Remediation of the site Clean-up following a plausible accidentlincident Long-term aftercare for residual environmental liabilities.
The Plan should include a statement or details of provisions made for the underwriting of these costs/liabilities.
The details of Abatement Installation, Control & Monitoring cost will be exactly as operated under licence PO462-01, Corden Pharma Ltd do not plan to install additional abatement, control & monitoring equipment. Corden will provide operating costs to The Agency, along with a Residual Management Plan for closure & remediation of site and aftercare of potential residual environmental liabilities if identified, within a 12 month period from licence transfer.
To ensure that your application is valid and can be processed please submit payment of one of the following amounts with your application to transfer the licence;
IPPC Licence Transfer Application - €2,000
We, the undersigned, are appiying to the Environmental Protection Agency, as per Section 94 of the Environmental Protection Agency Acts 1992 to 2007 for the transfer of licence no
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Transfer of Licence Application Form
PO462-01 from Johnson Matthey Pharmaceutical Materials Ireland Ltd to Corden Pharma Ltd (t/a Corden PhannaChern)
Licensee
.pany Sea 11 Company Seal
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Transfer of Licence Application Form
ATTACHMENT A
A.1 PO462-01
K V M Site\Env\ IPC Licence.pdf
A.2 Ammendment A to PO462-01
K V M Site\Env\ Arnrnendment to 1
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Headquarters, Johnstown Castle Estate, County Wexford, Ireland
INTEGRATED POLLUTION CONTROL LICENCE
Licence Register Number:
Licensee:
Location of Activity:
462
Cascade Biochem Limited
4, OC Commercial Park,
Little Island,
Cork.
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Environmental Protection Agency lPC Licence Reg. Np 462
Table of Contents Page No.
Glossary ............................................. ....... ........ ................. 1
Activities Licensed.. ..... .......................... 3
Condition 1. Scope ..............................................................
Condition 2. Management of the Activity
Condition 3. Interpretation ......................................................................................... ..5
Condition 4. Notification ............................................................................................................ 5
Condition 5. Emissions to Atmosphere ......................................................................... 6
Condition 6. Emissions to Sewer ......................................... ......................... 6
Condition 7. Waste Management .............................................................................................. 7
Condition 8. Noise ........................ Condition 9. Non-Process Water ..............................................................................
......................................
......................................................................... 3
.......................................................................... 7
..... 8
Condition 10. Monitoring ............................................................................................ a Condition 11, Recording and Reporting to Agency .....................................................
Condition 12. Emergency Response ...... Condition 13. Residuals Management ................................. ........... .............. 10
Schedule l(i) Hazardous Wastes for DisposafRecovery
....................................................................... I O
Condition 14. Financial Provisions .......................................................................................... 10
............... 11
Schedule l(ii) Other Wastes for DisposafRecovery ................................................................. I I
Schedule 2(i) Recording and Reporting to the Agency ............................................................. 12
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Environmental Protection Agency IPC Licence Reg. Ne 462
The Agency
The Licensee
AER
Annually
BATNEEC
Biannually
Daily
Day
Daytime
dB(A)
EMP
EPA
EWC
Fortnightly
I PC
K
kPa
Leq
List I
List I I
Local Authority
Monthly
Night-time
Glossary of Terms
Environmental Protection Agency.
Cascade Biochem Limited, 4, OC Commercial Park, Little Island, Cork.
Annual Environmental Report.
All or part of a period of twelve consecutive months.
Best Available Technology Not Entailing Excessive Cost.
All or part of a period of six consecutive months.
During all days of plant operation, and in the case of emissions, when emissions are taking place; with no more than 1 measurement on any one day.
Any 24 hour period.
0800 hrs to 2200 hrs.
Decibels (A weighted).
Environmental Management Programme.
Environmental Protection Agency
European Waste Catalogue (94/3/EEC, see also Agency Guidance Note on the EWC)
At least 20 measurements in a calendar year with no more than one measurement in any one week.
Integrated Pollution Control.
Kelvin.
kilo Pascals.
Equivalent continuous sound level.
As listed in the EC Directives 76/464/EEC and 80/68/EEC and amendments.
As listed in the EC Directives 7614641EEC and 80168lEEC and amendments.
Cork County Council.
At least 12 times per year at approximately monthly intervals.
2200 hrs to 0800 hrs.
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Environmental Protection Agency lPC Licence Reg. Ne 462
Noise sensitive location
PER
Quarterly
Standard Methods
TA Luft
Waste disposal operation
Waste recovery operation
Weekly
Any dwelling house, hotel or hostel, health building, educational establishment, place of worship or entertainment, or any other facility or area of high amenity which for its proper enjoyment requires the absence of noise at nuisance levels.
Pollution Emission Register.
All or part of a period of three consecutive months beginning on the first day of January, April, July or October.
As detailed in "Standard Methods for the Examination of Water and Wastewater", (prepared and published jointly by A.P.H.A., A.W.W.A 8, W.E.F) 19th Ed. 1995, American Public Health Association. 1015 Fifteenth Street, N.W., Washington DC 20005, USA.
Technical Instructions on Air Quality Control - TA Luft in accordance with art. 48 of the Federal lmmission Control Law (BlmSchG) dated 15 March 1974 (BGBI. I p.721). Federal Ministry for Environment, Bonn 1986 and amendments.
Means any of the operations included in the Third Schedule to the Waste Management Act 1996.
Means any of the operations included in the Fourth Schedule to the Waste Management Act 1996.
During all weeks of plant operation, and in the case of emissions, when emissions are taking place; with no more than one measurement in any one week.
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Environmental Protection Agency IPC Licence Reg. Np 462
Activities Licensed In pursuance of the powers conferred on it by the Environmental Protection Agency Act, 1992, the Agency hereby grants this Integrated Pollution Control licence to:
Cascade Biochem Limited, 4, OC Commercial.Park, Little Island, Cork
under Section 83(1) of the said Act to carry on the following activity
:- The manufacture of pharmaceutical intermediates
at 4, OC Commercial Park, Little Island, Cork subject to the following conditions (14) with the reasons therefor and associated schedules attached thereto.
Conditions
Condition 1. Scope
1 .I
1.2
The activity shall be controlled, operated, and maintained and emissions shall take place as set out in this Integrated Pollution Control licence. All programmes required to be carried out under the terms of this licence, become part of this licence.
No alteration to, or reconstruction in respect of, the activity or any part thereof which would, or is likely to, result in a material change or increase in:
1.2.1
1.2.2
1.2.3
1.2.4
The nature or quantity of any emission,
The abatemenutreatment or recovery systems,
The range of processes to be carried out,
The fuels, raw materials, intermediates, products or wastes generated,
or any changes in:
The site management and control with adverse environmental significance 1.2.5
shall be carried out or commenced without prior notice to, and without the prior written agreement of, the Agency.
This licence is for the purposes of IPC licensing under the EPA Act, 1992 only and nothing in this licence shall be construed as negating the licensee’s statutory obligations or requirements under any other enactments or regulations.
Any reference in this licence to ‘site’ shall mean the plan area edged in black and labelled Unit 4 on Drawing No. 9653-1 ‘Site Layout Plan’ in the IPC licence application.
1.3
1.4
1 Reason: To clarify the scope of this licence.
Condition 2. 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 all operations and review all practicable options for the use of cleaner technology, cleaner production and the reduction and minimisation of waste, and shall include as a minimum those elements specified in the Conditions 2.2 to 2.9 below:
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Environmental Protection Agency IPC Licence Reg. Np 462
2.2 A schedule of Environmental Objectives and Targets
2.2.1 The licensee shall prepare a schedule of Environmental Objectives and Targets. The schedule shall include time frames for the achievement of set targets. The schedule shall address a five year period as a minimum. The schedule shall be prepared to the satisfaction of the Agency and shall be submitted to the Agency within four months of date of grant of this licence. The schedule shall be reviewed annually and amendments thereto notified to the Agency for agreement as part of the Annual Environmental Report (AER) (See also Condition 2.9).
2.2.2 The licensee shall have regard to those matters listed in Schedule 2 Recording & Reporting to the Agency when establishing the schedule of Objectives and Targets.
2.3 Environmental Management Programme (EMP)
2.3.1 The licensee shall, not later than six months from the date of grant of this licence, submit to the Agency for agreement an EMP, including a time schedule, for achieving objectives and targets. Once agreed the EMP shall be established and maintained by the licensee. 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.
The EMP shall be reviewed annually and amendments thereto notified to the Agency for agreement as part of the Annual Environmental Report (AER) (Condition 2.9).
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 reports shall be retained on-site for a period of not less than seven years and shall be available 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 each year by reference to the list specified in the AER guidance note. The PER shall be prepared in accordance with any relevant guidelines issued by the Agency and 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 this licence and thereafter as part of the AER, agree with the Agency the list of substances to be included in the PER, and the methodology to be used in their determination.
2.5 Documentation
2.5.1 The licensee shall establish and maintain an environmental management documentation 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 whose duties relate to any condition of this licence.
2.6 Corrective Action
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Environmental Protection Agency IPC Licence Reg. Ne 462
2.7
2.8
2.9
2.6.1 The licensee shall establish procedures to ensure that corrective action is taken should the specified requirements of this licence not be fulfilled. The responsibility and authority for initiating further investigation and corrective action in the event of a reported non-conformity with this licence shall be defined.
Awareness and Training
2.7.1 The licensee shall establish and maintain procedures for identifying training needs, and for providing appropriate training, for all personnel whose work can have a significant effect upon the environment. Appropriate records of training shall be maintained.
2.7.2 Personnel performing specifically assigned tasks shall be qualified on the basis of appropriate education, training and/or experience, as required.
Responsibilities
2.8.1 The licensee shall ensure that a person in charge, as defined under the terms of the Environmental Protection Agency Act, 1992 shall be available on-site at all times when the activity is in operation. The person in charge shall also be available to meet with authorised persons of the Agency at all reasonable times.
Communications
2.9.1 The licensee shall put in place a programme to ensure that members of the public can obtain information concerning the environmental performance of the licensee at all reasonable times. This programme shall be submitted for agreement 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 grant of this licence, and each calendar year thereafter, an AER which shall be to the satisfaction of the Agency. This report shall include as a minimum the information specified in Schedule 2(i) Recording & Reporting to the Agency and shall be prepared in accordance with any relevant guidelines issued by the Agency.
Reason: To make provision for management of the activity on a planned basis having regard to the desirability of ongoing assessment, recording and reporting of matters affecting the environment.
Condition 3. Interpretation
3.1 Noise
3.1.1 Noise from the activity shall not give rise to sound pressure levels (Leq,T) measured at the boundary of the activity which exceed the limit value@).
Reason : To clarify the interpretation of emission limit values fixed under the licence.
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Environmental Protection Agency If C Licence Reg. NQ 462
Condition 4. Notification
4 1
4.2
4.3
4.4
The licensee shall notify the Agency by both telephone and facsimile, if available, to the Agency's Headquarters in Wexford, or to such other Agency office as may be specified by the Agency, as soon as practicable after the occurrence of any of the following:
4.1.1 Any emission which does not comply with the requirements of this licence.
4.1.2 Any incident with the potential for environmental contamination of surface water or groundwater, or posing an environmental threat to air or land, or requiring an emergency response by the Local Authority.
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 avoid recurrence.
The licensee shall make a record of any incident as set out in Condition 4.1 above. The notification given to the Agency shall include details of the circumstances giving rise to the incident and all actions taken to minimise the effect on the environment and minimise wastes generated.
A summary report of reported incidents shall be submitted to the Agency as part of the AER. The information contained in this report shall be prepared in accordance with any relevant guidelines issued by the Agency.
In the event of any incident, as set out in Condition 4.1.2 having taken place, the licensee shall notify the Local Authority as soon as practicable, after such an incident.
I Reason : To provide for the notification of incidents and update information on the activity. I
Condition 5. Emissions to Atmosphere
5.1 There shall be no emission to the atmosphere of environmental significance.
5.2 The licensee shall ensure that all operations on-site shall be carried out in a manner such that air emissions and/or odours do not result in significant impairment of, or significant interference with amenities or the environment beyond the site boundary.
The licensee shall prepare a programme, to the satisfaction of the Agency, for the identification and reduction of fugitive emissions to air. This programme shall be included in the Environmental Management Programme.
5.3
Reason: To provide for the protection of the environment by way of control, limitation, treatment and monitoring of emissions.
Condition 6. Emissions to Sewer
6.1 There shall be no emission to sewer other than domestic effluent and glassware washings.
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Environmental Protection Agency lPC Licence Reg. NQ 462
6.2 A representative sample of effluent shall be screened for the presence of organic compounds on a monthly basis. A report on the screening shall be submitted to the Agency quarterly and a summary report as part of the AER.
Reason: By way of control, limitation, treatment and monitoring of emissions to provide for the protection of the environment.
Condition 7.
7.1
7.2
7.3
Waste Management
Disposal or recovery of waste shall take place only as specified in Schedule I(;) Hazardous Waste for DisposaURecovery and Schedule I($ Other Wastes for DisposaVRecovery of this licence and in accordance with the appropriate National and European legislation and protocols. No other waste shall be disposed ofhecovered either on-site or off-site without prior notice to, and prior written agreement of, the Agency.
Waste sent off-site for recovery or disposal shall only be conveyed to a waste contractor, as agreed by the Agency, and only transported from the site of the activity to the site of recovery/disposal in a manner which will not adversely affect the environment.
A full record, which shall be open to inspection by authorised persons of the Agency at all times, shall be kept by the licensee on matters relating to the waste management operations and practices at this site. This record shall as a minimum contain details of the following:
7.3.1
7.3.2
7.3.3
7.3.4
7.3.5
7.3.6
The names of the agent and transporter of the waste.
The name of the persons responsible for the ultimate disposal/recovery of the waste.
The ultimate destination of the waste.
Written confirmation of the acceptance and disposallrecovery of any hazardous waste consignments sent off-site.
The tonnages and EWC Code for the waste materials listed in Schedule I(i, Hazardous Waste for DisposaVRecovery and Schedule l(ii) Other Wastes for DisposaYRecovery, sent off-site for disposaVrecovery.
Details of any rejected consignments.
A copy of this Waste Management record shall be submitted to the Agency as part of the AER for the site.
Reason: To provide for the disposal/recovery of waste and the protection of the environment.
Condition 8. Noise
8.1 Activities on-site shall not give rise to noise levels at the boundary which exceed the following sound pressure limits (Leq,l5min) subject to Condition 3 of this licence:
8.1.1 Daytime: 55 dB(A)
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Environmental Protection Agency lPC Licence Reg. Np 462
8.1.2 Night-time: 45 dB(A).
8.1.3 There shall be no clearly audible tonal component or impulsive component in the noise emission from the activity at any noise sensitive location.
Reason: To provide for the protection of the environment by control of noise.
Condition 9. Non-Process Water
9.1 Facilities for the Protection of Groundwater and Surface Water
9.1.1 All tank and drum storage areas shall be rendered impervious to the materials stored therein. In addition, tank and drum storage areas shall, as a minimum be bunded, either locally or remotely, to a volume not less than the greater of the following;
(i) 110% of the capacity of the largest tank or drum within the bunded area
(ii) 25% of the total volume of substance which could be stored within the bunded area.
Drainage from bunded areas shall be diverted for collection and safe disposal. All bunds shall be tested at least once every three years. A report on such tests shall be included in the AER.
9.1.2 The loading and unloading of materials shall be carried out in designated areas protected against spillage and leachate run - off. While awaiting disposal, all materials shall be collected and stored in designated areas protected against spillage and leachate run - off.
9.1.3 The licensee shall undertake a programme of testing and inspection of underground tanks and pipelines to ensure that all underground effluent and foul sewer pipes are tested at least once every three years. A report on such tests shall be included in the AER.
9.1.4 The licensee shall have in storage an adequate supply of containment booms and suitable absorbent material to contain and absorb any spillage.
Reason: To provide for the protection of surface waters and groundwater.
Condition I O . Monitoring
10.1 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 before mixing takes place.
10.2 Monitoring and analysis equipment shall be operated and maintained as necessary so that monitoring accurately reflects the emission or discharge.
10.3 The frequency, methods and scope of monitoring, sampling and analyses, as set out in this licence, may be amended with the written agreement of the Agency following evaluation of test results.
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Environmental Protection Agency IPC Licence Reg. Ne 462
10.4 The licensee shall install on all emission points such sampling points or equipment, including any data-logging or other electronic communication equipment, as may be required by the Agency. All such equipment shall be consistent with the safe operation of all sampling and monitoring systems.
The licensee shall provide safe and permanent access to the following sampling and monitoring points:
10.5.1 Effluent from sump
10.5.2 Waste storage areas on-site.
and safe access to any other sampling and monitoring points required by the Agency.
10.5
Reason: To ensure compliance with the requirements of other conditions of this licence by provision of a satisfactory system of measurement and monitoring of emissions.
Condition 11. Recording and Reporting to Agency
1 1 .I The licensee shall record all sampling, analyses, measurements, examinations, calibrations and maintenance carried out in accordance with the requirements of this licence.
11.2 The licensee shall record all incidents which affect the normal operation of the activity and which may create an environmental risk.
11.3 The licensee shall record all complaints of an environmental nature related to the operation of the activity. Each such record shall give details of the date and time of the complaint, 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. The licensee shall submit a report to the Agency, during the month following such complaints, giving details of any complaints which arise. A summary of the number and nature 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 the Agency. Records shall be retained on-site for a period of not less than seven years and shall be available for inspection by the Agency at all reasonable times.
1 1.5 Reports of all recording, sampling, analyses, measurements, examinations, calibrations and maintenance as set out in Schedule 2(i) Recording and Reporting to the Agency of this 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 and three copies shall be submitted as and when specified.
1 1.6 Provision shall also be made for the transfer of environmental information, in relation to this 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 Manager or 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.
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Environmental Protection Agency lPC Licence Reg. Ne 462
11.9 The frequency and scope of reporting, as set out in this licence, may be amended with the written agreement of the Agency following evaluation of test results.
I Reason: To provide for the collection and reporting of adequate information on the activity. I
Condition 12. Emergency Response
12.1 The licensee shall within six months of the date of grant of this licence, ensure that a documented Emergency Response Procedure is in place, which shall address any emergency situation which may originate on-site. This Procedure shall include provision for minimising the effects of any emergency on the environment.
Reason: To provide for the protection of the environment.
Condition 13. Residuals Management
13.1 Following termination, or planned cessation for a period greater than six months, of use or involvement of all or part of the site in the licensed activity, the licensee shall decommission, render safe or remove for disposal/recovery, any soil, subsoils, buildings, plant or equipment, or any waste, materials or substances or other matter contained therein or thereon, that may result in environmental pollution.
Reason: To make provision for the proper closure of the activity ensuring protection of the environment.
Condition 14. Financial Provisions
14.1 Agency Charges
14.1.1 The licensee shall pay to the Agency an annual contribution of f1,555 or such sum as the Agency from time to time determines, towards the cost of monitoring the activity as the Agency considers necessary for the performance of its functions under the Environmental Protection Agency Act, 1992. The licensee shall in 1999 and subsequent years, not later than January 31 of each year, pay to the Agency this amount updated in accordance with changes in the Consumer Price Index from the date of the licence to the renewal date. The updated amount shall be notified to the licensee by the Agency. For 1998, the licensee shall pay a pro rata amount from the date of this licence to December 31 1998. This amount shall be paid to the Agency within one month of the date of grant of this licence
Reason: measures to protect the environment.
To provide for adequate financing for monitoring and financial provisions for
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Environmental Protection Agency lPC Licence Reg. NQ 462
Schedule I(;) Hazardous Wastes for Disposal/Recovery
7 - - - - --- --. 9 - - . ”.-- . -.
; Waste Mate !
Non chlorinated waste solvent
Solid Chemical Waste
Laboratory Waste
Aqueous wastes
Other Note
None
None
None
None
None
None
None
None
Agreed hazardous waste disposal contractor.
Agreed hazardous waste disposal contractor.
Agreed hazardous waste disposal contractor.
Agreed hazardous waste disposal contractor.
Note 1:
Note 2:
The licensee may treat. reuse, recycle or recover waste subject to the priorwritten agreement of the Agency.
Any variation from those contractors named in the IPC Licence application, or subsequent agreements, must have the prior written agreement of the Agency. In cases where a previously agreed waste contractor is considered by the Agency not to exercise due care in respect of the transport and disposal of the licensees waste, the Agency may at any time instruct a licensee to stop using this contractor.
No other hazardous waste shall be disposed of/recovered off-site or on site without prior notice to, and prior written agreement of the Agency
Note 3:
Schedule l(ii) Other Wastes for Disposal/Recovery
Agreed disposal contractor. 1- d
Office and canteen waste None
Other Note --..-,-A_ Note 1 :
Note 2:
The licensee may treat, reuse, recycle or recover waste subject to the prior written agreement of the Agency.
Any variation from those contractors named in the IPC Licence application, or subsequent agreements, must have the prior written agreement of the Agency. In cases where a previously agreed waste contractor is considered by the Agency not to exercise due care in respect of the transport and disposal of the licensees waste, the Agency may at any time instruct a licensee to stop using this contractor.
No other waste shall be disposed of/recovered off-site without prior notice to, and prior written agreement of the Agency Note 3:
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t
Effluent screen Report
Complaints (where these arise)
Annual Environment Report(AER)
Environmental Protection Agency If C Licence Reg. NP 462
Quarterly Ten days after end of the quarter being reported on. I Monthly
Annually
Ten days afler end of the month being reported on.
Eighteen months from the date of grant of licence and each year thereafter.
I
Schedule 2(i) Recording and Reporting fo fhe Agency
Programme for public information.
Pollution emission register proposal
Schedule of Environmental Objectives and Targets
1 Environmental management programme proposal.
Completed reports shall be submitted to:
Within six months of the date of grant of licence.
Within six months of the date of grant of licence.
Within four months of the date of grant of licence.
Six months from the date of grant of licence.
The Environmental Protection Agency P.O. Box 3000 Johnstown Castle Estate County Wexford
- or
Reports are required to be forwarded as set out below:
Any other address as may be specified by the Agency
Recurring Reports:
Effluent screen summary report
Waste management report.
Resource consumption summary,
Complaints summary.
Schedule of Environmental Objectives and Targets
Environmental management programme - proposal
Environmental management programme - report
Pollution emission register - proposal
Pollution emission register - report
Tank and pipeline testing and inspection report
Reported incidents summary
Reduction in waste sent for disposal
Fugitive emissions programme
. 0 n ce-off Reports :
Signed on behalf of the Agency lain Maclean Dated this 20Ih November 1998
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1 Environmental Protection Agency An Ghnlomhoireochf uni Ctioomhnu Comhshaorl
Licence Register Number: Licensee:
Headquarters P.O. Box 3000
Johnstown Castle Estate County Wexford
Ireland
462 Cascade Biochem Limited
AMENDMENT A TO
INTEGRATED POLLUTION PREVENTION & CONTROL LICENCE
Location of Installation: 4 OC Commercial Park, Little Island, County Cork
L I 1
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Reason for the Amendment of Conditions
The Environmental Protection Agency has examined the terms of licence Reg. No. 462 as required by the provisions of Section 82 (10) (a) of the Environmental Protection Agency Acts 1992 and 2003, and deteimined that the licence can be brought into conformity with the provisions and requirements of Council Directive 96/6 1/EC by the exercise of the powers conferred by Section 82 (1 1) of the Environmental Protection Agency Acts 1992 and 2003.
The Environmental Protection Agency is satisfied, on the basis of the infoimation available, that subject to compliance with the conditions of licence Reg. No. 462 granted on the 20 November 1998, as well as any amendments noted herein, any emissions from the activity will comply with and not contravene any of the requirements of Section 83(5) of the Environmental Protection Agency Acts, 1992 and 2003.
Amendment of Conditions In pursuance of the powers conferred on it by Section 82( 1 1) of the Environmental Protection Agency Acts, 1992 and 2003, the Agency amends Licence Reg. No. 462, granted to Cascade Biochem Limited, 4 OC Commercial Park, Little Island, County Cork.
This amendment is limited to the following conditions of Licence Reg. No. 462:
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Amendments Glossary of Terms
BAT Best Available Techniques.
~ ~~
To be inserted into the Glossary of the existing licence..
2.10. Resource Use and Energy Efficiency
2.10.1. The licensee shall carry out an audit of the energy efficiency of the site within one year of the date of grant of this amendment. The audit shall:-
(i) identify all opportunities for energy use reduction and efficiency,
(ii) be carried out in accordance with the guidance published by the Agency; “Guidance Note on Energy Efficiency Auditing” and
be repeated at intervals as required by the Agency. (iii)
The recommendations of the audit will be incorporated into the Schedule of Environmental Objectives and Targets under Condition 2 above.
The licensee shall identify opportunities for reduction in the quantity of water used on site including recycling and reuse initiatives, wherever possible. Reductions in water usage shall be incorporated into the Schedule of Environmental Objectives and Targets.
The licensee shall undertake an assessment of the efficiency of use of raw materials in all processes, having particular regard to the reduction in waste generated. The assessment should take account of best international practice for this type of activity. Where improvements are identified, these shall be incorporated into the Schedule of Environmental Objectives and Targets.
2.10.2.
2.10.3.
1 To be inserted after Condition 2.9 of the e,risting licence. I
I Reason: To provide for the eficient use of resources and energy in all site operations. I
12.2. Accident Prevention and Emergency Response
12.2.1 The licensee shall, within twelve months of date of this amendment, ensure that a documented Accident Prevention Policy is in place, which will address the hazards on-site, particularly in relation to the prevention of accidents with a possible impact on the environment. This procedure shall be reviewed annually and updated as necessary.
12.2.2 The Emergency Response Procedure shall be reviewed annually and updated as necessary.
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12.2.3 In the event of an incident the licensee shall immediately:-
(I)
(ii)
(iii)
(iv)
isolate the source of any such emission;
carry out an immediate investigation to identify the nature, source and cause of the incident and any emission arising therefrom;
evaluate the environmental pollution, if any, caused by the incident;
identify and execute measures to minimise the emissionsimalfunction and the effects thereof;
(v) identify the date, time and place of the incident.
Provide a proposal to the Agency for its agreement within one month of the incident occurring or as otherwise agreed with the Agency to:-
* identify and put in place measures to avoid reoccurrence of the incident; and identify and put in place any other appropriate remedial action.
1 To be inserted after Condition 12.1 of the existing licence. I
Reasori: To provide for the protection of the eravironment.
These amendments should be read in conjunction with licence Reg. No. 462, granted on 20 November 1998.
Sealed by the seal of the Agency on this the 17fh day of October 2005
PRESENT when the seal of the Agency was affixed hereto:
Padraic Larkin, Director/Authorised Person
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Transfer of Licence Application Form
ATTACHMENT B
(a) Certified Copy of Certificate of Incorporation
Corden business name.pdf Corden Cert of 1ncorporation.pdf
(b) & (c)Company's Number in Company's Registration Office and Particulars of
"Comoanv details 20071:pdf' Registered Office of the Company.
Does the proposed transferee have a parent company ?As below. Does the proposed transferee have any subsidiaries involved in the industrial installation or waste
facility management? No
Address of Body Corporate : INTERNATIONAL CHEMICAL INVESTORS GROUP
(if applicable) An der Hauptwache 5
603 13 Frankfurt
Germany
Contact e-mail address : info@,ic-investors.com
Phone +49 (69) 506 999-0 Fax +49 (69) 506 999-1 1
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Section 7 of the above Act requires that \vhcne\w a change is n u d e or occuis in 311) ol'the particulars regislered i n respccl of any person, that person shall, within one nionrh afti-r the chance. f'urnish by sending by post or delivering to the registrar a siatemenr in writing in the prescribed form specifying the nature and date of the change signed and \vherc necessary verified in like manner as the stateiiicnt required on re&' wtrai ion.
Section 8 (2i provides that "a ceriificare of registration shall be kept exhibited in a conspicuous position at, in the case of a firm or individual, rhe principal p l ~ c of business and. in the case o f a body corporate. iis registered or principal office in the State and, in e\;ciy c x c , in every branch office or place wherc the business is normslly carried on; and if not kepr so exhibited. the person regisrered or, in the case of'a firm. every iiartner in the firni shail be liabic on suinmary conviction to a fine not eacredin~ El??." Section 12 (I)--- " i f a pcrson registered under this Acr 1:i rcspcct oPa busincis name ccxes to carry 01)
business iindrr t h i i name, i t shall be ihe <{tit? of 1ha1 person or, in ihe case of an indi \ idiisi iiho dits. or' his personal rcpreseiitatkc 0 1 . in the case O f Z flm;. ofi.\e:). pc:wn w!io i\iis 3 par~tiicr i i i ijic Crni ai :he tiiiic t ihen it c c i f a body cor-pxitc. of any Iiqui33tirr. tvithiti threc month.\: h r r i f i e r :o send h? post o r d s 1 1 ~ ~ ~ io ri:c resistr::r 2 satcmtr.i in the piesiribeci :i7i.m :ti {hat sffec;; ar:d i{he niahc.!: tkf;iu\t i n doin? sit hc
shali be liablc on s i i i n ~ ~ u r ) c o i i i ; ~ c t i ~ ~ to ;j iiiis no: esccedinggl 27."
ii t o carr) on business uncici r h ~ i nanic. 2nd 3l>t;. :n iiic C ~ S C
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I c o rp oat- a ti o la
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Company Registration Number: 45559
Secretary and Registered Office:
M r Vincent O’Brien
90 South Mall
Cork
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Transfer of Licence A-pplicution Form
ATTACHMENT C
1. Indicate whether the applicant or other relevant person has been convicted under the PoE Act, the Waste Management Act 1996 to 2008, the Local Government (Water pollution) Acts 1977 and 1990 or the Air Pollution Act 1987.
Corden PharmaChem has not been convicted under any of the above mentioned Acts. Other relevant personnel and bodies include the senior personnel noted below. Previous company names used at Corden PharmaChem premises, Irish Fher Laboratories Ltd, Irotec laboratories Ltd, Cambrex Profarmaco Cork Ltd and Cambrex Cork Ltd. None of these bodies or persons have been convicted under any of the above mentioned Acts.
2. Provide details of the applicant's technical knowledge and/or qualifications, along with that of other relevant employees . In relation to Question 2 please give details here for each person who will or is likely to have responsibility for licensed activities, to include:
(a ) the names of all persons who are to provide the management and supervision of the activities authorised by the licence, in particular the name of the facility manager and any nominated deputies;
(b)details of the responsibilities for each individual named under a) above; and
(c)details of the relevant education, training and experience held by each of the persons nominated under a) above.
Attached in are qualifications and experience of Senior Personnel on site o Managing director o R&D and Process Development Manager
Managing director 81 d
"Curriculum Vitae Paudie.doc"
R&D and Process Development Manager
q-7 I
"Curriculum VitaeJA 0 Neill.doc"
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Curriculum Vitae
Name:
Date of Birth: 24/07/63
Nationality : Irish
Patrick Burke, Cambrex Cork Ltd.
Qualifications:
1981 - 1985
1989
1999
Employment:
1985 - 1989
1989 - 1992
1992 - 1997
1997 - 2001
2002 to 2006
2007
B. Commerce, U.C.C., Cork. Ireland.
1989 Member of Institute of Chartered Accountants in Ireland (ICAI)
1999 Fellow of ICAI
Audit Senior, KPMG, Cork.
Accounting Section Head, Irotec Laboratories Limited, Cork.
Financial Controller, Irotec Laboratories Limited, Cork.
Site Manager, Irotec Laboratories, Cork.
Managing Director, Cambrex Cork Ltd., Cork.
Managing Director, Corden PharmaChein, Cork.
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Curriculum Vitae
John Anthony O'Neill, B.Sc., Ph.D. C. Chem. MRSC
Positions Held
Corden PharmaChem, Co. Cork (2001 to present) Research and Development Manager.
Pfizer Pharmaceuticals, Loughbeg, Co. Cork (1995 to 2001) (formerly Warner-Lambert and Hickson PhannaChem) Process Development Chemist Department a1 Supervisor Technology Transfer Manager
Manro Products Ltd., Stalybridge, England (1 989-1990) Senior Development Chemist
Beecham Pharmaceuticals, Epsom, England (1 987 to 1989) Process Development Chemist
Academic Qualifications
BioResearch Ireland/ University College Cork, Ireland (1 994 to 1995) Post-Doctorate Research
University of BristoUAgroEvo (1 990 to 1993) Industrially sponsored Ph.D. in organic synthesis and bio-synthetic studies
University of Limerick (1 983 to 1987) B.Sc. in Industrial Chemistry
Publications
J. A. O'Neill, T. J. Simpson and C. L. Willis, "Biosynthesis of Colletodiol and Related Polyketide Macrodiolides in Cytospora sp. ATCC 20502: Synthesis and Metabolism of Advanced Intermediates", J. Chein. Soc., Chem. Conzm., 1993, 738
J. A. O'Neill, T. J. Simpson and C. L. Willis, "Structures of Bartanol and Iso-butanol, Novel Macrodiolide Metabolites from Cytospora sp ATCC 20502", J. Chein. Soc., Perkin Trans. I , 1994, 2493-2497
J. A. O'Neill, S. D. Lindell, T. J. Simpson and C. L Willis, "A Simple Enantioselective Synthesis of g- Valerolactone", Tetrahedioiz Asymmetry, 1994,5, 117-1 18
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Trans f ir of' Licence Application Form
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.
Corden PharmaChem has a financial and operational record extending beyond thirty years which Is unblemished. We have never sought a scheme of arrangement, either formally o r informally with our creditors. (Bur bona fides were again demonstrated by our approach to the shutdown of manufacturing activities, the consequent employee support plan and the ongoing completion of Residual Management Plan for IPPC PO134-03, as agreed with the Agency, in 2009.
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Transfer of Licence Aplication Form
ATTACHMENT D
Please provide a statement to show that the person to whom a licence is transferred has assumed and accepted all liabilities, requirements and obligations provided for in or arising under the licence, or revised licence, regardless of how and in respect of what period, including a period prior to the transfer of the licence or revised licence they may arise.
Johnson Matthey is not aware of any incident occurring during the period of our occupation of the site that would require remediation under the terms of the licence granted by the Environmental Protection Agency.
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ATTACHMENT E
Has the proposed transferee, their parent company or any 'relevant person' had an application for a licence granted? Please provide details here or separately as Attachment E.
TPPC PO134-03, Corden Pharma Ltd t/a Corden PharmaChem
V:\2008\ Environmental\IPF
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Environmental Protection Agency An Ghnromhnircooit urn Chnornhnu Conrtrshooii
Licence Register Number:
Licensee:
Headquarters P.O. Box 3000
Johnstown Castle Estate County Wexford
Ireland
PO 134-03
Corden Pharma Limited
INTEGRATED POLLUTION PREVENTION & CONTROL LICENCE
Location of Installation: Wallingstown, Little Island, County Cork
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INTRODUCTION
This introduction is not pai-t of tlic licence and does not pui-poi-t to be a legal interpretation of the licence.
Corden Phaima Limit e d man ti Fac ture active ph ai-ma ceu ti c a1 in gi-edi en ts and in t el-medi ates for other phainiaceutical manufacturers, generic phaimaceutical suppliers and clinical h-ids. They are located on an 8-hectare site in the Little Island Industrial Estate and normally operate on a 3 shift 24-hour basis, five days a week. They were granted an IPC licence (PO134-01) in 1997. This licence was reviewed in 1999 and an amended licence (PO134-02) issued.
The licence sets out in detail the conditions under which Corden Phaima Limited, Wallingstown, Little Island, County Cork will operate and manage this installation.
I11 trocl~lcl io11
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Envrr.orinierifnl Protectioii Agency Licence Ken M’ PO13403
Table of Contents Glossary of Terms Decision & Reasons for the Decision Part I Schedule of Activities Licensed Pai-t I1 Schedule of Activities Refused Part I11 Conditions
Condition 1.
Condition 2.
Condition 3.
Condition 4.
Condition 5.
Condition 6.
Condition 7.
Condition 8.
Condition 9.
Condition 10.
Condition 1 1.
Condition 12.
SCHEDULE A: SCHEDULE B: SCHEDULE C: SCHEDULE D:
Scope
Management of the Installation
Infrastructure and Operation
Interpretation
Emissions
Control and Monitoring
Resource Use and Energy Efficiency
Materials Handling
Accident Prevention and Emergency Response
Decommissioning and Closure
Notifications, Records and Reports
Financial Charges and Provisions
Limitations Emission Limits Control & Monitoring Annual Environmental Report
Page No. 1 5 6 6 7
7
7
9
11
13
13
15
15
16
16
17
19
21 21 24 31
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Eiivil-orinieiitril Protectiori A,peric)i ___ Licence Re,? M PO134-03
G~QSSWY of Terms
All terms in this licence should bc iiitei-pi eted in accoidmce n i d i the definitions i n the Envnonmental Piotectioii Agency Acts 1992 to 2007 / \Vaste Management Acts 1996 to 2007, unless otherwise defined in this section.
Adequate lighting
AER
Agreement
Annually
A tt aclimen t
Application
Appropriate facility
BAT
Biannually
Biennially
BOD
CEN
COD
Construction and demolition (C & D) waste
Containment boom
Daily
Day
Daytime
DB(A)
DO
Documentation
20 lux measured at gi-otind le\.el
Annual Eiwii-oninental Iiepoit
Agreement In writing
At approximately twelvemonthly intervals.
Any reference to Attachments in this licence refers to attachments submitted as pait of this licence application.
The application by the licensee for this licence.
A waste management facility, duly authorised under relevant law and technically suitable.
Best Available Techniques.
All or part of a period of six consecutive months.
Once every two years.
5 day Biochemical Oxygen Demand.
Cornit6 Europien De Normalisation - European Committee for Standardisation.
Chemical Oxygen Demand.
Wastes that arise from construction, renovation and demolition activities: Chapter 17 of the EWC or as otherwise may be agreed.
A boom that can contain spillages and prevent them from entering drains or watercourses or from further contaminating watercourses.
During all days of plant operation, and in the case of emissions, when emissions are taking place; with at least one measurement on any one day.
Any 24 hour period.
0800 hrs to 2200 hi-s.
Decibels (A weighted).
Dissolved oxygen.
Any report, record, result, data, drawing, proposal, interpretation or other document in written or electronic foim which is required by this licence.
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Eiiviroizriieritrrl Protectzori A,qeric)i Licence Re,? If‘ POl34-03
Drawing
EMP
Emission limits
Environmental damage
E PA
European Waste Catalogue (EWC)
Facility
Fortnightly
Gas Oil
G U M S
Green waste
Heavy metals
HFO
Hours of operation
ICP
Incident
I lid us t r ial waste
histallation
IPPC
Any reference to a drawing or drawing number means a drawing or drawing number contained in the application, unless otherwise specified in this licence.
Environmental Management Programme.
Those limits, including concentration limits and deposition rates, established in Schedule B: Eiiiissioii 1,inzit.s of this licence.
Has the meaning given it in Directive 200413SIEC.
Environmental Protection Agency
A harmonised, non-exhaustive list of wastes drawn up by the European Commission and published as Commission Decision 200015321EC and any subsequent amendment published in the Official Journal of the European Community.
Any site or pi-emises used for the purposes of the recovery 01- disposal of waste
A minimum of 24 times per year, at approximately two week intervals
As defined in S.I. 13 of 2001.
Gas chrornatographyimass spectroscopy.
Waste wood (excluding timber), plant matter such as grass cuttings, and other vegetation.
This term is to be interpreted as set out in “Parameters of Water Quality, Interpretation and Standards” published by the Agency in 2001. ISBN 1-84095- 015-3.
Heavy fuel oil as defined in S.I. 13 of 2001.
The hours during which the installation is authorised to be operational.
Inductively coupled plasma spectroscopy
The following shall constitute an incident for the purposes of this licence:
(i) an emergency; (ii) any emission which does not comply with the requirements of this
licence; (iii) any trigger level specified in this licence which is attained or
exceeded; and, (iv) any indication that environmental pollution has, or may have, taken
place.
As defined in Section 5(1) of the Waste Management Acts 1996 to 2007
A stationaiy technical unit or plant where the activity conceined refelTed to in the First Schedule of EPA Acts 1992 to 2007 is or will be calmed on, and shall be deemed to include any directly associated activity, which has a technical connection with the activity and is calmed out oii the site of the activity.
Integrated Pollution Prevention & Control.
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K
kPa
Leq
Licensee
List I
List I I
Local Authority
Ma i 11 tai n
Mass flow limit
Mass flow threshold
Monthly
Night-time
Noise-sensitive location (NSL)
Oil separator
PRTR
Quarterly
Regional Fisheries Board
Sanitary effluent
Sample(s)
SOP
Specified emissions
Kelvin.
Kilopascal s.
Equivalent continuous sound level
Corden Phainia Limited, Wallingsto\vn. Little Islmd. County Cork.
As listed in the EC Dii ectives 76/443/CEC and S0’6SlEEC and amendments.
As listed in the EC Dnectibes 7614641EEC and S0’68i’EEC and amendments.
Cork County Council.
Keep in a fit state, including such regular inspection, servicing, calibration and repair as may be necessary to adequately perform its fLinction.
An emission limit value which is expressed as the maximum mass of a substance that can be emitted per unit time.
A mass flow rate above which a concentration limit applies.
A minimum of 12 times per year, at intervals of approximately one month.
2200 hrs to 0800 hrs
Any dwelling house, hotel or hostel, health building, educational establishment, place of worship or entertainment, or any other installation or area of high amenity which for its proper enjoyment requires the absence of noise at nuisance levels.
Device installed according to the International Standard I.S. EN 858-2:2003 (Separator systems for light liquids, (e.g. oil and petrol) - Part 2: Selection of nominal size, installation, operation and maintenance).
Pollutant Release and Transfer Register.
All or part of a period of three consecutive months beginning on the first day of January, April, July or October.
South Western Regional Fisheries Board.
Wastewater from installation toilet, washroom and canteen facilities
Unless the context of this licence indicates to the contrary, samples shall include measurements by electronic instruments.
Standard operating procedure
Those emissions listed in Sckediile B: Enzissiorz Liriiits of this licence.
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Standard method A National, European or internationally recognised procedure (e.g., I.S. EN, BO, CEN, BS or equivalent) or an in-house documented procedure based on the above references; a procedure as detailed in the current edition of “Standard Methods for the Examination of Water and Wastewater” (prepared and published jointly by A.P.H.A., A.W.W.A. & W.E.F.), American Public I-lealth Association, 1015 Fifteenth Street, N.W., Washington DC 20005, IJSA; or, an alternative pe thod as may be agreed by the Agency.
Storm water Rain water run-off from roof and non-process areas.
l h e Agency Environmental Protection Agency.
Luft Technical Instructions on Air Quality Control - TA Luft in accordance with art. 48 of the Federal Immission Control Law (BImSchG) dated 15 March 1974 (BGBI. I p.721). Federal Ministry for Environment, Bonn 1986, including the amendment for Classification of Organic Substances according to section 3.1.7 TA.Luft, published in July 1997.
TOC Total organic carbon.
Trade effluent Trade effluent has the meaning given in the Water Pollution Acts 1977 and 1990.
Trigger level A parameter value, the achievement or exceedance of which requires certain actions to be taken by the licensee.
voc/svoc Volatile Organic CompoundsiSemi-Volatile Organic Compounds
Water Services Cork County Council. Aut t i ori t y
Weekly During all weeks of plant operation, and in the case of emissions, when emissions are taking place, with at least one measurement in any one week.
WWTP Waste water treatment plant.
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Decision & Reasonsfor the Decision The Environmental Protection Agency is satisfied, on the hasis of the infoimation available, that subject to compliance with the conditions of this licence, any emissions fioni the activity will comply with and will not contravene any of the requn-ements of Section S ( 5 ) of the Environmental Protection Agency Acts 1992 to 2007.
In i-eaching this decision the Envii-onmental Protection Agency has considered the application, supporting documentation and objcction I-eceived fiom the applicant, rind the repoits of its inspectors.
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Part I Schedule of Activities Licensed
In pui-suance of the powers conferred on it by the Environmental Protection Agency Acts 1992 to 2007, the Agency hereby grants a revised licence to:
Col-den Phaima Limited, Wallingstown, Little Island, County Cork,
under Section 90(2) of the said Acts to carry on the following activity:
: - The use of a chemical or biological process for the production of basic phamiaceutical products,
at Wallingstown, Little Island, County Cork, subject to the following twelve Conditions, with the reasons therefor and associated schedules attached thereto.
Part II Schedule of Activities Refused
None of the proposed activities as set out in the licencti application have been se3ised
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1.1
1.2
1.3
1.4
1.5
1.6
,4ctivities at this installation shall be limited as set o u t i n ,%h&/e A: Linzitnfioris of this licence.
The installation shall be controlled; operated, and maintained and emissions shall take place as set out in this licence. AI1 progi-ammes I-eciuired to be can-ied out under the terms of this licence, become part of this licence.
For the purposes of this licence, the installation authonsed by this licence is the area of land outlined in red in Figure 4.3.2 of the application. Any refei-ence in this licence to “installation” shall mean the area thus outlined in red. The licensed activity shall be can-ied on only within the area outlined.
No alteration to, or reconstruction in respect of, the activity 01- any part thereof which would, or is likely to, result in
(i) a material change or inci-ease in: 1 . 1
1
The nature or quantity of any emission,
The abatement/h-eatment or recovery systems,
The range of processes to be carried out,
The fuels, raw mateiials, intermediates, products or wastes generated, or
(ii) any changes in:
1 Site management infrastructure or conh-ol with adverse environmental significance,
shall be carried out or commenced without prior notice to, and without the agreement of, the Agency.
This licence is for the purposes of IPPC licensing under the EPA Acts 1992 to 2007 only and nothing in this licence shall be construed as negating the licensee’s statutory obligations or requirements under any other enactments or regulations.
This licence has been granted in substitution for licence granted to the licensee on 3/6/1999 (Register No PO134-02). The previous licence (Reg. No. PO134-02) is superseded by this revised licence.
I Reason: To clarlfy the scope of this licence. I
Condition 2. Management of the Installation
2.1 Installation Management
2.1 . I The licensee shall employ a suitably qualified and experienced installation manager who shall be designated as the person in charge. The installation manager or a nominated, suitably qualified and experienced, deputy shall be present on the installation at all times during its operation or as otlieiwise required by the Agency.
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2.1.2 The licensee shall ensure that personnel perfoiming specifically assigned tasks shall be qualified on the basis of appropriate education, training and expeiience, as required and shall be aware of the requirements of this licence.
2.2 Environmental .Management System (EMS)
2.2.1 The licensee shall maintain an Environmental Management System (EMS). The EMS shall be updated on an annual basis.
The EMS shall include as a minimum the following elements:
2.2.2.1 Management and Reporting Structure.
2.2.2.2 Schedule of Environmental Objectives and Targets
The licensee shall maintain a Schedule of Environmental Objectives and Targets. The schedule shall as a minimum pi-ovide for a review of all operations and processes, including an evaluation of practicable options, for energy and resource efficiency, the use of cleaner technology, cleaner production, and the prevention, reduction and minimisation of waste, and shall include waste reduction targets. The schedule shall include time frames for the achievement of set targets and shall address a five year period as a minimum. The schedule shall be reviewed annually and amendments thereto notified to the Agency for agreement as part of the Annual Environmental Report (AER).
2.2.2
2.2.2.3 Environmental Management Programme (EMP)
The licensee shall, maintain an EMP, including a time schedule, for achieving the Environmental Objectives and Targets prepared under Condition 2.2.2.2. Once agreed the EMP shall be maintained by the licensee. It shall include:
(i)
(ii)
(iii)
The EMP shall be reviewed annually and amendments thereto notified to the Agency for agreement as part of the Annual Environmental Report (AER) (Condition 1 1.8).
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 reports shall be retained on-site for a period of not less than seven years and shall be available for inspection by authorised persons of the Agency.
designation of responsibility for targets;
the means by which they may be achieved;
the time within which they may be achieved.
2.2.2.4 Documentation
(i) The licensee shall maintain an environmental management documentation system, which shall be to the satisfaction of the Agency.
The licensee shall issue a copy of this licence to all relevant personnel whose duties relate to any condition of this licence.
(ii)
2.2.2.5 Corrective Action
The licensee shall establish procedui-es to ensure that corrective action is taken should the specified requirements of this licence not be fulfilled. The responsibility and authority for initiating further investigation and coirective action in the event of a repoited non- confoimity with this licence shall be defined.
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2.2.2.6 Awareness and Training
The licensee shall maintain procedui-cs for idcntifying haining needs, and for providing appropriate training. for all personnel whose work can have a significant effect upon the environment. Appropiiate records of training shall be mainiained.
2.2.2.7 Communications Programme
The licensee shall maintain a Public Awareness and Coinmunications Programme to ensure that members of the public are infomied, and can obtain infoimation at the installation, at all ~-easonable times, concerning the envIronmeiital performance of the installation.
2.2.2.8 Maintenance Programme
The licensee shall maintain a programme for maintenance of all plant and equipment based on the insh-uctions issued by the manufactmer/suyplier or installer of the equipment. Appropriate record keeping and diagnostic testing shall suppoit this maintenance programme. The licensee shall clearly allocate responsibiljty for the planning, management and execution of all aspects of this programme to appropriate personnel (see Condition 2.1 above).
2.2.2.9 Efficient Process Control
The licensee shall maintain a programme to ensure there is adequate control of processes under all modes of operation. The programme shall identify the key indicator parameters for process control performance, as well as identifying methods for measuring and controlling these parameters. Abnormal process operating conditions shall be documented, and analysed to identify any necessary corrective action.
Reason: To makeprovision for management of the activity on aplanned basis having regard to the desirability of ongoing assessment, recording and reporting of matters affecting the environment.
Condition 3. Infrastructure and Operation
3.1 The licensee shall establish all infrastructure referred to in this licence in advance of the commencement of the licensed activities or as required by the conditions of this licence.
3.2 Installation Notice Board
3.2.1 The licensee shall, provide and maintain an Installation Notice Board on the installation so that i t is legible to persons outside the main entrance to the installation. The minimum dimensions of the board shall be 1200 mm by 750 mm.
3.2.2 The board shall clearly show:
(I) (ii) (iii) (iv)
the name and telephone number of the installation; the noimal hours of operation; the name of the licence holder; an emergency out of hours contact telephone number;
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(v) (vi)
the licence reference number; and where environmental information relating to the installation can be obtained.
The licensee shall install on all emission points such sampling points or equipment, including any data-logging or other elechonic communication equipment, as may be required by the Agency. All such equipment shall be consistent with the safe operation of all sampling and monitoring systems.
3.3
3.4
3.5
3.6
3.7
3.8
In the case of composite sampling of aqueous emissions fi-om the operation of the installation a separate composite sample or homogeneous sub-sample (of sufficient volume as advised) should be refrigerated immediately after collection and retained as required for EPA use.
The licensee shall clearly label and provide safe and peimanent access to all on-site sampling and monitoring points and to off-site points as required by the Agency.
Tank, Container and Drum Storage Areas
3.6.1 All tank, container and drum storage areas shall be rendered impervious to the materials stored therein. Bunds should be designed having regard to Agency guidelines ‘Storage and Transfer of Materials for Scheduled Activities’ (2004).
3.6.2 All tank and drum storage areas shall, as a minimum, be bunded, either locally or remotely, to a volume not less than the greater of the following: (I) I 10% of the capacity of the largest tank or drum within the bunded
area; or (ii) 25% of the total volume of substance, which could be stored within
the bunded area.
3.6.3 All drainage from bunded areas shall be treated as hazardous waste unless it can be demonstrated to be otherwise. All drainage from bunded areas shall be diverted for collection and safe disposal.
3.6.4 All inlets, outlets, vent pipes, valves and gauges must be within the bunded area.
3.6.5 All tanks, containers and drums shall be labelled to clearly indicate their contents.
The licensee shall have in storage an adequate supply of containment booms and/or suitable absorbent material to contain and absorb any spillage at the installation. Once used the absorbent material shall be disposed of at an appropriate facility.
Fire-water Retention
3.8.1 The licensee shall maintain sufficient capacity in the containment pond for the retention of contaminated firewater as identified in the report “Firewater Retention and study of the bund capacity of Storage facilities” dated 8/1/2006, submitted as part of the application.
3.8.2 In the event of a fire or a spillage to stoim water, the site storm water shall be diverted to the containment pond and Production Area Surface Drainage system as outlined in the “Firewater Retention and study of the bund capacity of Storage facilities” dated 8/1/2006, submitted as part of the application.
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3.9
3.10
3.1 1
3.12
3.13
3.14
3.S.3 The licensee shall have i-egard to the Ciiwonniental Protection Agency Draft Guidance Note to Industry on the Iieqiiii-ements for Fire-Water Retention Facilities when implementing Conditions 3.8.1 and 3.S.2 above.
All pump sumps, storage tanks, lagoons or other treatment plant chambei-s from which spillage of environmentally significant materials might occur i n such quantities as are likely to breach local or remote containment or separator, shall be fitted with high I i q ~ i i d level alanns (or oil detectors ;is appropriate) within six months fi-om the date of grant of this licence.
The provision of a catchment system to collect any leaks from flanges and valves of all over-ground pipes used to transport matenal other than water shall be examined. This shall be incorporated into a schedule of objectives and targets set out in Condition 2.2.2.2 of this licence for the reduction in fugitive emissions.
All wellheads, as shown on Drawing IPC 117, of the licence application shall be adequately protected to prevent contamination or physical damage.
The licensee shall, maintain in a prominent location on the site a wind sock, or other wind direction indicator, which shall be visible from the public roadway outside the site.
Natural gas shall be used in the boilers on-site. ln the event of an inteii-uption to the supply of natural gas, an alternative fuel such as gas oil or biodiesel meeting CEN standard EN14214 may be used with the prior written agreement of the Agency.
Waste gas streams going to the Thermal Oxidiser shall contain less than 1% halogenated organic substances expressed as chlorine. The licensee shall agree with the Agency a method to demonstrate that this level is not exceeded.
Reason: To provide foi- appropriate opei*ation of the installatioi7 to eiisiire pvotectioii of the eizviroiimeiit.
Condition 4. Interpretation
4.1 Emission limit values for emissions to atmosphere in this licence shall be interpreted in the following way:
4.1,l Continuous Monitoring
(i)
(ii)
No 24 hour mean value shall exceed the emission limit value
97% of all 30 minute mean values taken continuously over an annual period shall not exceed 1.2 times the emission limit value.
No 30 minute mean value shall exceed twice the emission limit value.
(iii)
4.1.2 Non-Continuous Monitoring
(i) For any parameter where, due to saniplingianalytical limitations, a 30 minute sample is inappropi-iate, a suitable sampling period should be employed and the value obtained therein shall not exceed the emission limit value.
For flow, no hourly or daily mean value, calculated on the basis of appropriate spot readings, shall exceed the relevant limit value.
For all other parameters, no 30 minute mean value shall exceed the emission limit value.
(ii)
(iii)
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Eiivrroiiiiieiifal Protectioii Ageiici, Licerice Rep l\p PO134-03
(iv) Mass flow thresholds refer to a rate of discharge expressed in units of kgih, above which the concenh-ation emission limit value applies. Mass flow threshold rates shall be determined on the basis of a single 30 minute measurement (i.e. the concenhation determined as a 30 minute average shall be multiplied by an appropriate measurement of flow and the result shall be expressed in units of kgih).
(v) Mass flow limits shall be calculated on the basis of the concenh-ation, determined as an average over the specified period, multiplied by an appropriate measurement of flow. No value, so determined, shall exceed the mass flow limit value.
The concenhation and volume flow limits for emissions to atmosphere specified in this licence shall be achieved without the introduction of dilution air and shall be based on gas volumes under standard conditions o f
4.2.1
4.2
In the case of non-combustion gases:
Temperature 273K, Pressure 101.3 kPa (no correction for oxygen or water con tent) .
In the case of combustion gases:
Temperature 273K, Pressure 101.3 W a , dry gas; 3% oxygen n for liquid and gas fuels; 6% oxygen for solid fuels.
In the case of combustion gases from the thermal oxidiser:
Temperature 273 K; Pressure 101.3 IcPa; dry gas (no correction for oxygen content).
4.2.2
4.2.3
4.3 Emission limit values for emissions to sewedwaters in this licence shall be interpreted in the following way:
4.3.1 Continuous Monitoring
(i)
(ii)
(iii)
No flow value shall exceed the specified limit.
No pH value shall deviate from the specified range.
No temperature value shall exceed the limit value.
4.3.2 Composite Sampling
(i)
(ii)
No pH value shall deviate from the specified range.
For parameters other than pH and flow, eight out of ten consecutive composite results, based on flow proportional composite sampling, shall not exceed the emission limit value. No individual result similarly calculated shall exceed 1.2 times the emission limit value.
4.3.3 Discrete Sampling
For parameters other than pH and temperature, no grab sample value shall exceed 1.2 times the emission limit value.
4.4 Where the ability to measure a parameter is affected by mixing before emission, then, with agreement from the Agency, the parameter may be assessed before mixing takes place.
4.5 Noise
Noise from the installation shall not give rise to sound pressure levels (Leq, T) measured at NSLs, which exceed the limit value(s).
I Rensoii: To clai-lfy the iizteiprefntion oflimit vnlues$.xed wider the licence. I
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Condition 5. Emissions
5.1 No specified emission from the installation shall exceed the eniission limit values set out in S c h e h l c B: Eiizissioiz Linzifs of this licence. There shall be no other emissions of environmental significance.
No emissions, including odours, from the activities carried on at the site shall result in an impaiiment of, or an interference with amenities or the environment beyond the installation boundary or any other legitimate uses of the environment beyond the installation boundary.
No substance shall be discharged in a manner, or at a concentration, that, following initial dilution, causes tainting of fish or shellfish.
The licensee shall at no time discharge or permit to be discharged into the sewer any liquid matter or thing that is or may be liable to set or congeal at average sewer temperature or is capable of giving off any inflammable or explosive gas 01- 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.
5.2
5.3
5.4
Rerisoii: To provide for theprotectioiz of the eizvironmeiit by way of control aiid liiiiitutioiz of einissioizs and to provide for the requirements of the Water SeiiJices Atithority in accordance with Section 99E of the EPA Acts 1992 to 2007.
Condition 6. Control and Monitoring
6.1 The licensee shall cairy out such sampling, analyses, measurements, examinations, maintenance and calibrations as set out below and as in accordance with Schedule C: Control a77d Monitoring of this licence:
6.1.1 Analysis shall be undertaken by competent staff in accordance with documented operating procegures.
Such procedures shall be assessed for their suitability for the test matrix and performance characteristics determined.
Such procedures shall be subject to a programme of Analytical Quality Control using control standards with evaluation of test responses.
Where analysis is sub-contracted it shall be to a competent laboi-atoiy.
6.1.2
6.1.3
6.1.4
The licensee shall ensure that:
(1)
6.2
sampling and analysis for all parameters listed in the Schedules to this licence, and
any reference measurement methods to calibrate automated measurement systems,
(ii)
shall be caiiied out in accordance with CEN-standards. If CEN standards are not available, KO, national or international standards which will ensure the provision of data of an equivalent scientific quality shall apply.
All autoinatic monitors and samplers shall be functioning at all times (except duiing maintenance and calibration) when the activity is being carried on unless alternative sampling or monitoring has been agreed in writing by the Agency for a limited period. In the event of the malfunction of any continuous monitor, the licensee shall contact the Agency as soon as practicable, and alternative sampling and monitoring facilities shall be put in place. Agreement for the use of alternative equipment, other than in emergency situations, shall be obtained from the Agency.
6.3
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Erivirorinier~/cil Pro/ection Agericv Licerice Reo. I” PO134-03
6.4
6.5
6.6
6.7
6.8
6.9
6.10
6.1 1
6.12
6.13
6.14
6.15
Monitoring and analysis equipment shall be operated and maintained as necessary so that monitoring accurately reflects the emission or discharge.
The licensee shall ensure that groundwater monitoilng well sampling equipment is availableiinstalled on-site and is fit for purpose at all times. The sampling equipment shall be to Agency specifications.
All heatmentiabatement and emission control equipment shall be calibrated and maintained in accordance with the instructions issued by the manufacturerisupplier or installer.
The fiequency, methods and scope of monitoring, sampling and analyses, as set out in this licence, may be amended with the agreement of the Agency following evaluation of test results.
The licensee shall prepare a programme, to the satisfaction of the Agency, for the identification and reduction of fugitive emissions using an appropriate combination of best available techniques. This programme shall be included in the Environmental Management Programme.
The integrity and water tightness of all underground pipes, tanks, bunding structures and containers and their resistance to penetration by water or other materials canied or stored therein shall be tested and demonstrated by the licensee. This testing shall be carried out by the licensee at least once every three years and reported to the Agency on each occasion. This testing shall be carried out in accordance with any guidance published by the Agency. A written record of all integrity tests and any maintenance or remedial work arising from them shall be maintained by the licensee.
Bunds shall be inspected weekly, and the drainage system and bunds shall be properly maintained at all times, and desludged as necessary. All sludge and drainage from these operations shall be collected for safe disposal.
Storm Water
A visual examination of the storm water discharge shall be carried out daily. A log of such inspections shall be maintained.
Noise
The licensee shall carry out a noise survey of the site operations annually. The survey programme shall be undertaken in accordance with the methodology specified in the ‘Environmental Noise Survey Guidance Document’ as published by the Agency.
Pollutant Release and Transfer Register (PRTR)
The licensee shall prepare and report a PRTR for the site. The substances andor waste to be included in the PRTR shall be agreed by the Agency each year by reference to EC Regulation No. 16612006 concerning the establishment of the European Pollutant Release and Transfer Register and amending Council Directives 91/689/EEC and 96/61/EC. The PRTR shall be prepared in accordance with any relevant guidelines issued by the Agency and shall be submitted electronically in specified foimat and as part of the AER.
The licensee shall, within six months of the date of grant of this licence, develop and establish a Data Management System for collation, archiving, assessing and graphically presenting the environmental monitoring data generated as a result of this licence.
The licensee shall permit authorised persons, of the Agency and Water Services Authority, to inspect, examine and test, at all reasonable times, any worI(s and apparatus installed in connection with the process effluent and to take samples of the process effluent.
~ ~ ~ ~ ~~
Reason To provide for the protection of the e~ivironnzeiit by way of treat~iieiit a d nzonitorziig of e~~i is~zoi is aiid to provide for the reqziirements of the Water Sewices Author7ty 7iz
acxordaiice with Sectioii 99E of the EPA Acts 1992 to 2007
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E~ivii~o~inieiitril t”i-otectiori Ageiicy Licence Ren. Ap PO134-03
Condition 7. Resource Use and Energy Efficiency
7. I The licensee shall cany out an audit of the energy efficiency of the site within one year of the date of grant of this licence. The audit shall be cai-ried out in accordance with the guidance published by the Agency, “Guidance Note on Energy Efficiency Auditing”. The energy efficiency audit shall be repeated at inteivals as required by the Agency.
The audit shall identify all opportunities for energy use reduction and efficiency and the recommendations of the audit will be incorporated into the Schedule of Environmental Objectives and Targets under Condition 2.2.2.2 of this licence.
The licensee shall identify opportunities for reduction in the quantity of water used on site including recycling and reuse initiatives, wherever possible. Reductions in water usage shall be incorporated into Schedule of Environmental Objectives and Targets under Condition 2.2.2.2 of this licence.
The licensee shall undertake an assessment of the efficiency of use of raw materials in all processes, having particular regard to the reduction in waste generated. The assessment should take account of best international practice for this type of activity. Where improvements are identified, these shall be incorporated into the Schedule of Environmental Objectives and Targets under Condition 2.2.2.2 of this licence.
7.2
7.3
7.4
I Reuson: To provide for the efficient use of I-esoiirces and e n e i p in all site opei-ations. I
Condition 8. 8.1
8.2
8.3
8.4
8.5
8.6
8.7
Materials Handling Waste sent off-site for recovery or disposal shall be transported only by an authorised waste contractor. The waste shall be transported from the site of the activity to the site of recoveiy/disposal only in a manner that will not adversely affect the environment and in accordance with the appropriate National and European legislation and protocols.
The licensee shall ensure that waste in advance of transfer to another person shall be classified, packaged and labelled in accordance with National, European and any other standards which are in force in relation to such labelling.
The loading and unloading of materials shall be caiiied out in designated areas protected against spillage and leachate run-off.
Waste shall be stored in designated areas, protected as may be appropiiate against spillage and leachate run-off. The waste is to be clearly labelled and appropriately segregated.
No waste classified as green list waste in accordance with the EU Transfrontier Shipment of Waste Regulations (Council Regulation EEC No. 25911 993, as amended) shall be consigned for recovery without the agreement of the Agency.
Waste for disposal/recovery off-site shall be analysed in accordance with Sckerlule C: Control & Monitoring of this licence.
Unless approved in wilting by the Agency the licensee is prohibited from mixing a hazardous waste of one category with a hazardous waste of another category or with any other non-hazardous waste.
Reason. To provide for the appropriate handling of materials ant1 the protecfioii ofthe eiivironine~it.
Poge 15 of31
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Condition 9. Accident Prevention and Emergency Response
9.1 The licensee shall, within SIX months of date of grant of this licence, ensure that a documented Accident Prevention Procedure is in place, which will address the hazards on-site, particularly in relation to the prevention of accidents with a possible impact on the environment. This procedure shall be reviewed annually and updated as necessary.
The licensee shall, within six months of date of grant of this licence, ensure that a documented Emergency Response Procedure is in place, which shall address any emergency situation, which may originate on-site. This procedure shall include provision for minimising the effects of any emergency on the environment. This procedure shall be reviewed annually and updated as necessary.
9.2
9.3 Incidents
9.3.1 In the event of an incident the licensee shall immediately:
(i)
(ii)
(iii) evaluate the environmental pollution, if any, caused by the
(iv) identify and execute measures to minimise the
(v)
(vi) The licensee shall provide a proposal to the Agency for its agreement within one month of the incident occumng or as otherwise agreed by the Agency to:
(i) identify and put in place measures to avoid reoccurrence of the incident; and
(ii) identify and put in place any other appropriate remedial action.
caii-y out an investigation to identify the nature, source and cause of the incident and any emission arising therefrom;
isolate the source of any such emission;
incident;
emissions/malfunction and the effects thereof;
record the date, time and place of the incident;
notify the Agency and other relevant authorities.
9.3.2
Reason: To provide for the protection ofthe environilzent.
Condition 10. Decommissioning and Closure
10.1 Following teiniination, or planned cessation for a period gye-eater than six months, of use or involvement of all or part of the site in the licensed activity, the licensee shall, to the satisfaction of the Agency, decommission, render safe or remove for disposal/recovei-y, any soil, subsoils buildings, plant or equipment, or any waste, materials or substances or other matter contained therein or thereon, that may result in environmental pollution.
10.2 Residuals Management Plan
10.2.1 The licensee shall pi-cpai-e, to the satisfaction of the Agency, a fully detailed and costed plan for the decommissioning or closure of the site or part thereof. This plan shall be submitted to the Agency for agreement within six months of the date of grant of this licence.
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10.2.2 The plan shall be reviewed annually and pi-oposed amendments thereto notified to the Agency for agreement as part of the AER. No amendments may be implemented without the agreement of the Agency.
10.2.3 The licensee shall have regard to the Environmental Protection Agency Guidance on Environmental Liability Risk Assessment, Residuals Management Plans and Financial Provision when implementing Conditions 10.2 and 10.3 of this licence.
10.3 The Residuals Management Plan shall include, as a minimum, the following:
(i)
(ii)
a scope statement for the plan;
the criteria that define the successful decommissioning of the activity or part thereof, which ensures minimum impact on the environment;
(iii) a programme to achieve the stated criteria;
(IV) where relevant, a test progamme to demonstrate the successful implementation of the decommissioning plan;
(v) details of the costings for the plan and the financial provisions to underwrite those costs.
10.4 A final validation report to include a certificate of completion for the residuals management plan, for all or part of the site as necessary, shall be submitted to the Agency within three months of execution of the plan. The licensee shall carry out such tests, investigations or submit certification, as requested by the Agency, to confirm that there is no continuing risk to the environment.
Reason: To make provisioiz for the proper closure of the activity ensuriizgprotectioiz oftlie en vir0 J? nz enf.
Condition 11. Notifications, Records and Reports
1 1.1 The licensee shall notify the Agency by both telephone and facsimile, if available, to the EPA Regional Inspectorate, Office of Environmental Enforcement, Inniscarra, County Cork or to such other Agency office as may be specified by the Agency, as soon as practicable after the occurrence of any of the following:
(i) any release of environmental significance to atmosphere from any potential emission point including bypasses;
any emission which does not comply with the requirements of this licence; (ii)
(iii) any malfunction or breakdown of key control equipment or monitoring equipment set out in Schedule C: Control & Moizitoriizg of this licence, which is likely to lead to loss of control of the abatement system;
any incident with the potential for environmental contamination of surface water or groundwater, or posing an environmental threat to air or land, or requiring an emergency response by the Local Authority.
(iv)
The licensee shall include as part of the notification, date and time of the incident; summary details of the occurrence, and where available, the steps taken to minimise any emissions.
In the event of any incident which relates to discharges to sewer having taken place, the licensee shall notify the Local and Water Services Authority as soon as practicable, after such an incident.
1 1.2
Pqye 1 7 of 3 1
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11.3
11.4
11.5
11.6
11.7
11.8
The licensee shall make a record of any incident. This record shall include details of the nature, extent, and impact of, and circumstances giving rise to, the incident. The record shall include all corrective actions taken to manage the incident, minimise wastes generated and the effect on the environment, and avoid recurrence. The licensee shall, as soon as practicable following incident notification, submit to the Agency the incident record.
The licensee shall record all complaints of an environmental nature related to the operation of the activity. Each such record shall give details of the date and time of the complaint, the name of the complainant, (if provided), 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.
The licensee shall record all sampling, analyses, measurements, examinations, calibrations and maintenance carried out in accordance with the requirements of this licence and all other such monitoring which relates to the environmental perfoimance of the installation.
The licensee shall as a minimum keep the following documents at the site:
the licences relating to the installation;
the current EMS for the installation;
the previous year’s AER for the installation;
records of all sampling, analyses, measurements, examinations, calibrations and maintenance carried out in accordance with the requirements of this licence and all other such monitoring which relates to the environmental performance of the installation;
relevant correspondence with the Agency;
up to date site drawings/plans showing the location of key process and environmental infi-ash-ucture, including monitoring locations and emission points;
up to date Standard Operational Procedures for all processes, plant and equipment necessary to give effect to this licence or otherwise to ensure that standard operation of such processes, plant or equipment does not result in unauthorised emissions to the environment;
any elements of licence application or EIS documentation referenced in this licence;
and this documentation shall be available to the Agency for inspection at all reasonable times.
The licensee shall submit to the Agency, by the 3 1 st March of each year, an AER covering the previous calendar year. This report, which shall be to the satisfaction of the Agency, shall include as a minimum the information specified in Schedule D: Aiuzunl E7wiromzei1tal Report of this licence and shall be prepared in accordance with any relevant guidelines issued by the Agency.
A full record, which shall be open to inspection by authorised persons of the Agency at all times, shall be kept by the licensee on matters relating to the waste management operations and practices at this site. This record shall be maintained on a monthly basis and shall as a minimum contain details of the following:
(i) the tonnages and EWC Code for the waste materials imported andor sent off- site for disposal/recovery;
(ii) the names of the agent and caiiier of the waste, and then waste collection peimit details, if required (to include issuing authority and vehicle registration number);
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(iii) details of the ultimate disposalirecovei-y destination facility for the waste and its appropiiateness to accept the consigned waste stream, to include its peimitilicence details and issuing authority, if required;
written confii-mation of the acceptance and disposalh-ecovery of any hazardous waste consignments sent off-site;
details of all wastes consigned abroad for Recovery and classified as 'Green' in accordance with the EU Transfrontier Shipment of Waste Regulations (Council Regulation EEC No. 2.5911993, as amended). The rationale for the classification must form part of the record;
(vi) details of any rejected consignments;
(vii) details of any approved waste mixing;
(viii) the results of any waste analyses required under Schedule C: Control & Moiiitoriilg of this licence.
(iv)
(v)
1 1.9 The licensee shall submit report(s) as required by the conditions of this licence to the EPA Regional Inspectorate, Office of Environmental Enforcement, Inniscarra, County Cork or to such other Agency office as may be specified by the Agency.
The licensee shall submit an up to date drawing showing the locations and names of all emission and monitoring points within three months of the date of grant of the license.
1 1 .IO
Reason: To provide for the collection arid reportiizg of adequate i)formatioii on the activity.
Condition 12. Financial Charges and Provisions
12. I Agency Charges
12.1.1 The licensee shall pay to the Agency an annual contribution of €16,800, or such sum as the Agency from time to time determines, having regard to variations in the extent of reporting, auditing, inspection, sampling and analysis or other functions carried out by the Agency, towards the cost of monitoring the activity as the Agency considers necessary for the performance of its functions under the Environmental Protection Agency Acts 1992 to 2007. The first payment shall be a pro-rata amount for the period fi-om the date of this licence to the 3 1 st day of December, and shall be paid to the Agency within one month from the date of the licence. In subsequent years the licensee shall pay to the Agency such revised annual conh-ibution as the Agency shall from time to time consider necessary to enable perfoimance by the Agency of its relevant functions under the Environmental Protection Agency Acts 1992 to 2007, and all such payments shall be made within one month of the date upon which demanded by the Agency.
In the event that the fi-equency or extent of monitoring 01- other functions cained out by the Agency needs to be increased the licensee shall conh-ibute such sums as determined by the Agency to defraying its costs in regard to items not covered by the said annual conhibution.
12. I .2
12.2 Water- Services Authority Chai-ges - 1 I he licensee shall pay to the Water Services Authority an annual monitoiing charge of €SO0 and other such sums as may be determined from time to time, having regard to the variations in the cost of providing drainage and the variation in effluent reception and treatment costs. Payment to be made on demand.
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Envlrormerifd Prolectron Agency Licence Reg. W’P0134-U3
12.3 Environmental Liabilities
12.3.1
12.3.2
12.3.3
12.3.4
The licensee shall as pait of the AER provide an annual statement as to the measures taken or adopted at the site in relation to the prevention of environmental damage, and the financial provisions in place in relation to the underwriting of costs for remedial actions following anticipated events (including closure) or accidentshcidents, as may be associated with the carrying on of the activity.
The licensee shall arrange for the completion, by an independent and appropriately qualified consultant, of a comprehensive and fully costed Environmental Liabilities Risk Assessment (ELRA), which addresses the liabilities from past and present activities. The assessment shall include those liabilities and costs identified in Condition 10 for execution of the RMPICRAMP. A report on this assessment shall be submitted to the Agency for agreement within twelve months of date of grant of this licence. The ELRA shall be reviewed as necessary to reflect any significant change on site, and in any case every three years following initial agreement: review results are to be notified as part of the AER.
As part of the measures identified in Condition 12.3.1, the licensee shall, to the satisfaction of the Agency, make financial provision to cover any liabilities identified in Condition 12.3.2. The amount of indemnity held shall be reviewed and revised as necessary, but at least annually. Proof of renewal or revision of such financial indemnity shall be included in the annual ‘statement of measures’ report identified in Condition 12.3.1.
The licensee shall have regard to the Erivironmental Protection Agency Guidance on Environmental Liability Risk Assessment, Residuals Management Plans and Financial Provision when implementing Conditions 12.3.2 and 12.3.3 above.
Reason: To provide for adequate fiizaizciizg for nzoizitoring and financial provisions for measures to protect the environment and to provide for the requirements of the Water Services Authority in accordance with Section 99E of the EPA Acts 1992 to 2007.
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SCHEDULE A: E iin i t a t ion s There are 110 limitations on the installation specified in the Schedule
SCHEDULE B: Emission Limits
Emission Point Reference No.:
Location:
Volume to be emitted:
A21 I
Thermal Oxrdiser, South of Production building 1
Maximum in any one day:
Maximum rate per houi-:
16.3 m above ground
120,000 m3
5,000 m'
Minimum discharge height:
i _ . Carbon monoxide
Sulphur dioxide
1 Ammonia OSkgihr , ~ I__I_II_xI_.I_I-^_
TOC Note 4 0.5 kgihr j
~ ~
8
- < I.-._ .- ._..._l_I-l.-.-l--.--l....l---l
Note 1:
Note 2:
Note 3:
Note 4:
Where oi-ganic substances of sevei-al classes are einitted simultaneously, in addition to the above individual limits, the sum of the concentrations of Classes I, I1 and I11 shall not exceed the Class 111 limits. The emission limit value refers to the total concentration of dioxins and furans calculated using the concept of toxic equivalence in accordance with Annex I of Directive 2000176iEC. The einission limit values of cat-ban monoxide (CO) concenti-ations shall not be exceeded in the coinbustion gases (excluding the start-up and shut-down phase). Emission Limit Value only applies when themial oxidiser is functioning correctly and not on bypass.
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Eizvwoririieritnl Protectzoll Agerzcli Liceuce Re,o hr, POl34-03
, / A215
Emission Point Reference Nos.: A212 PBI Air Handlmg Unit (folmerly A113) A213 PBI Air Handling Unit (formerly A114) A214 PBI Deduster (foimerly A119 A215 PB 1 Room Air Handling Unit (formerly A211 0) A216 PB2 HVAC Exhaust (formerly A211 7)
492,480 I 20,520 13 180,000 7,500 18 I
I 50,000
Emission Point Reference Nos.: A212 PB1 Air Handling Unit (formerly A113) A213 PB 1 Air Handling Unit (formerly A 1 14) A214 PB1 Deduster (formerly A115) A215 PB1 Room Air Handling Unit (formerly A2/10) A216 PB2 HVAC Exhaust (formerly A211 7)
j Pharmaceutical dust I 0.1 5mg/rn3 1 glhr 1 I
11__1_1_1 Il_i L
Emission Point Reference Nos.: A215 PBI Room Air Handling Unit (formerly A2110) A2/6 PB2 HVAC Exhaust (formerly A211 7)
the
J'nge 22 of 3 I
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Er~vironi~ierilirl Protect iori A geii L 1. _______ Licerice Re?. ,Ip PO134-03
B.2 Einissiorzs to Water
There shall be no Emissions to Water o f envjronmental significance.
B.3 Emissioii to Sewer
Emission Point Reference No.:
Name of Receiving Waters:
Location:
Volume to be emitted:
i Temperature t
j P H ,
BOD
COD
Suspended Solids
Total Nitrogen
Ammonia (as N)
Sulphates
Total Phosphorus (as P)
Cyanide
Total Heavy Metals
vocs Fats, Oils and Grease
SE1 (formerly SI)
Lough Mahon, following treatment in Carngrennan WWTP
Connection to WSA sewer at eastein boundary of site
Maximum in any one day:
Maxi~num rate per hour:
255 m3
20 m3
30°C (max.)
6.0 - 9.0
1,000
5,000
200
50
50
5 00
10
0.2
1 .o 10
10
kgtday
200
1,000
30
B.4 Noise Emissioiis
Note 1: Tlieie shall be no cleaily aiidible tonal component 01 impulsi\e component In the notse eln~sston 11om the ac tn i ty at a n y noise-sensiti\e I~cdt ion
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En w o n 111 eritnl Protectzon Agency Licerice Rep PO134-03
SCHEDULE C: Control & Monitoring
C.l.1 Control of Emissions to Air
Emission Point Reference No.:
Description of Treatment:
Control Parameter . . -. _ _ ___._._I. -. __
Scrubber Systetn Liquid Circulation
Air Flow
Vapour Absorption
PH
Catalytic Tliernial Oxidiser Vapour feed concentration
Bed Temperature
Air flow to Thermal Oxidiser
HCI
A21 1
Acid Vapour ScrubberiBasic Vapour Scrubber & Catalytic Thermal Oxidiser
Motor Trip Alatm/Daily visual inspection
Motor Trip AiandDaily visual inspection
Scheduled Inspection
Continuous
Continuous
Continuous
Flow meteriAlaim
Continuous
Note 1: The licensee shall maintain appropriate access to standby and/or spares system.
Circulation Pump
Fan
Packing
pH meter
Two independent LEL meters
Temperature measurement probe
Fan at Thennai Oxidiser
HCI monitor and alarm
ensure the operation of the abatement
Emission Point Reference No.:
Description of Treatment:
A2l2, A2f3, A214, A215 and A216
Dedusters, HEPA Filters
-,_- - - ~ - - _ . - "_ \
Key Equipmen ,*' r l !
Monitoring I
Note 1: The licensee shall maintain appropnate access to standby andlor spares to ensure the operation ofthe abatement system.
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c.1.2 Monitoring of Enzissiom to Air.
Emission Point Reference No.:
Parameter
TA Luft Organics Class I, I1 and 111
Dioxins (as TEQ)No'e ' Pharmaceutical dust
Hydrogen chloride
Nitrogen oxides as (NOZ)
Carbon monoxide
Sulphur dioxide
Ammonia
Hydrogen sulphide
Hydrogen bromide
Hydrogen cyanide rote I: To be cai~ied out when a inaxiinun
Emission Point Reference NO.:
A2/1 (Thermal Oxidiser)
1'1 on i to r i 11 g Frequency
Continuous TOC imoiithly ;ampling
4nnually
Ailnually
Continuous
Monthly
Monthly
Monthly
Monthly
Monthly (when in use)
Monthly (when in use)
Monthly (when in use) lad of chlorinated substances are
Analysis Method/Technique -I __ - - - -_ - Continuous TOC meter/ Standard Method
Standard Method
Standard Method
Infra-red
Standard Method
Standard Method
Standard Method
Standard Method
Standard Method
Standard Method
Standard Method :ly to be in use at the installation.
TA Luft Organics Class I, I1 and 111 1 Monthly Standard Method --- "--"I -""e-----
Emission Point Reference No.: A212, A213, A214, A215, A216
Total Particulates Annually \ Standard Method
Pharmaceutical Dust Annually ~ Standard Method , I_ -, _" _ _ .. ~. .. . .,~ . . . , ,. _I " , __ I l___-l_l,-. ". .,--...I .. . - -
I ., , __" .. ,,, , . . , .. . . - ... , .. . . ._l__.,_ . .. -- .-I -1-1 I".-... . .- I.---__ 1.". - ---:
Note 1 : Analysis for phannaceutlcol dusr shall only be I-equired whei-s the total particulates content ofthe eniission exceeds 0.1 51iigim3, and where the masstion, of total pairiculates exceeds I e/h~-.
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E~ivirori~iieiitul Protectloll A~erici Licence Reo N" PO13443
c. 2.1 Control of Emissions to Water
There shall be no emissions to water of environmental significance.
*>
c. 2.2 Monitoring of Emissioizs to Water
There shall be no emissions to water of environmental significance.
C. 2.3
Emission Point Reference No.: SWl
Monitoring of Storm Water Emissiorz
Parameter Monitoring Frequency
PH Temperature
BOD
COD
TOC
Flow
Visual Inspection
Weekly
Daily
Weekly
Daily
Continuous
Daily
Weekly
- - _. _- - - - Analysis
Met ho d/T ec hniq ue Standard Method
Standard Method
Standard Method
Standard Method
Standard Method
Standard Method
Sample and examine for colour and odour
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C. 3.1 Control of Emissions to Sewer.
Eniission Point Reference No.:
Description of Treatment:
Dissolved Oxygen
Flow (Feed)
Flow (Discharge)
PH
SE 1
Wastewater Treatment
Continuous DO
Continuous Flow
Continuous Flow
Continuous pH on Aeration basins, balance tank and daily reading on effluent sample.
Key Equipment So'e'
B 1 ow er s
Feed pump
Submersible Pump
Balance Tank pH meter Aeration Basins pH meter Outfall sump pH meter Effluent stream meter
Note 1 : The licensee shall mamtain appropriate access to standby andor spares to ensure the operation of the abatement system.
Sludge Condition
BOD
Sludge Volume Index
Mixed Liquor Suspended Solids Supernatant Clarity
Suspended solids
BOD: COD Ratio
Food/micro-organisms ratio
Monitoring
Twice Weekly
Weekly
Daily
Daily
Daily
Daily
Monthly
As required
Microscopy
Standard Method
Standard Method Standard Method
Cone Test
Standard Method
Standard Method
Standard Method
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C. 3.2 Moizitoring of Emissions to Sewer
-- Einission - - Point Reference No.: SEI1
Parameter <I--. I__ - j Flow
Temperature
PH Chemical Oxygen Demand
Biochemical Oxygen Demand
Suspended Solids
Cyanide
Ammonia (as N)
Total Nitrogen
Total Phosphorus (as P)
Sulphates
Metals (specify)
Total Heavy Metals ' Organic Substances
Oils, fats & greases 1 i ' Respirometry Note 1: The licensee shall install a CO
Continuous
Continuous
Continuous
Daily No'e
Weekly Note I
Weekly No'e ' Quarterly I
Monthly
Monthly No'e
Monthly I
Monthly No'e
Monthly Note I
Annually I
Monthly No'e
Monthly ' Annually No'e
mite sampler within three months of ~ l _
I-
- - -. - - - -
Analysis .Method/l'echnique - - -. . ..-I- ._ ...
On-line flow meter with recorder
On-line temperature probe with recorder
p H e lec t rodeheter and recorder
Standard Method
Standard Method
Standard Method
Standard Method
Standard Method
Standard Method
Standard Method
Standard Method
Standard Method
Standard Method
Standard Method
Standard Method
Standard Method
[e of grant of this licence. All samples thereafter lll-̂____ __ _II
shall be collected on a 24 how ow proportional composite sampling basis. Total heavy metal analysis to include Cr, Cu, Cd, Zn, Ni, Pb, CO, As, Hg and Se, with both individual metal results and sum total of results to be provided. Screening for pnoiity pollutant list substances (such as US EPA volatile and/or seini-volatile compounds). This analysis shall include those organic solvents in use in the process, which ai-e likely through noimal process operations to be diverted to the wastewater streams. Sampling for VOCs shall be on a grab sample basis and SVOCs may be sampled on a 24-hour composite basis, with the most appropriate method chosen based on the mix of organic substances pi-esent.
Note 2:
Note 3:
Note 4:
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c. 4 Waste Monitoring
Sludge from WWTP
Waste solvents
Solid waste including: pharmaceutical compounds, spent catalysts, still bottoms, reaction residues, filter cakes, spent absorbents
_ -
Bi-annually
Per consi giiment
Per consigiiments
Heavy Metals No'e2
Organic Matter
Water Content
Organic Substances No'e
As Agreed by the Agency
As Agreed by the Agency
__ . _ _ - Jlcthod
Standard Method
Standard Method
Standard Method
Standard Method
Process origin records / Standard Method
Process origin records / Standard Method
- Other Note ' rote 1:
Note 2:
Note 3:
Analytical I-equirements Total heavy metal analysis to include Cr, Cu, Cd, Zn, NI, Pb, CO, As, Hg and Se, with both individual metal results and sum total of 1-esults to be pi-ovided. Screening for priority pollutant list substances (such as US EPA volatile and/or semi-volatile compounds). This analysis shall include those organic solvents in use in the process, which a]-e likely through normal process operations to be diverted to the wastewater stl-earns.
be determined on a case by case basis.
c. 5 Noise Moizitoviizg
No additional noise monitoring is required in this schedule.
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ectio
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EPA Export 26-07-2013:18:27:37
Licmce REF i\l" PO134-03 Diviro~zmeritd Protection Agency
C. 6
Groundwater Monitoring
Am bieiz t Mort itoring
Location: MWI-A, MW3, MW4, MW5, MW6, MW?, MW8, W 9 , MWlO or at any
Parameter
Groundwater Level
PH Conductivity
Temperature
Nitrate
Total Ammonia
Total Nitrogen
Organic Compounds
Major Anions
Major Cations
Heavy Metals rote 1: Screening for priority I_ II
___I_ hcr locations specified bv L the Agsnc --
.Monitoring Frequency
Biannually
B i ailnuall y
Biannually
Biaimually
Biaimually
Biaiuiually
B ianuually
Biannually
Biannually
Biannually
Biannually substances (such as US EPA volatile an(
Analysis 31 et h o d/T ech n iq u e
Electronic Dip Meter
pH electrodeinleter
Standard Method
Thermometer
Standard Method
Standard Method
Standard Method
Standard Method
Standard Method
Standard Method
Standard Method r semi-volatile compounds).
--_-__
Note 2: An ionic balance to be presented, with and explanation of any significant error.
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~iilissioiis from the installation. 9nnual cooling water volume discharged from dryers. Waste management record. iesource consumption summary. :omplaints summary. 3cliedule of environmental objectives arid targets. Znvironnieiital management programme - report for previous year. Environmental inanagemelit programme - proposal for current year. Pollutant release and transfer register - report for previous year. Pollutant release and transfer register - proposal for current year. Noise moiutoring report sunimary. Ambient monitoring sumniary. Tank and pipeline testing and inspection report. Reported incidents summary. Energy efficiency audit report sununary. Report on the assessment of the efficiency of use of raw materials in processes and the reduction in waste generated. Report 011 progress made and proposals being developed to mininuse water demand and tlie volume of hade effluent discharge. Development/Infrastructural works summary (completed in previous year or prepared for current year). Reports on financial provision made under this licence, management and staffing structure of the installation, and a
Review of residuals mwagenieiit plan/closure, restoration & aftercare management Plan. Statement of measures in relation to prevention of eiivironmental damage and remedial actions (Environmental Liabilities). I Eiivironniental liabilities risk assessment review (every three years or more frequently as dictated by relevant on-site change including financial provisions. Any other itenis specified by the Agency. Note 1:
progranme for public infomiation. j
I !
! -4 --" ~-
Content may be revised subject to the agreement of the Agency.
Sealed by the seal of tlie Agency on this the 19"' day of February 2008.
PRESENT when the seal of the Agency Was affixed hereto:
Dr, Padraic Larkin, Director/Authorised Person
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