CD Placeholder - Environmental Protection Agency · IPPC Application Form A valid application must contain the information prescribed in the Environmental Protection Agency (Licensing)

CD Placeholder

This page denotes that a CD entitled ‘Novartis Ringaskiddy Ltd., Application form & Attachments” was

submitted as part of this licence application.

The CD can be viewed by request at:-

Licensing Unit, Office of Licencing & Guidance,

EPA, P.O. Box 3000

Johnstown Castle Estate, Wexford.

Tel: 053 60600

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Application form in .pdf format

_-__._- t

Application form and attachments in Word format f .-

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--.-__.- .__.. -. - -.__ _--- ---- . ..___ -- . ..--.-.---. .----.--. --.---

__-----.. .._-__-_ ______ --_-.-.----..----_--..-...

___-___---. ..--.__---_----- -.-- __.-~ .--------.----.-

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CD Placeholder

This page denotes that a CD entitled “Novartis Ringaskiddy Ltd., Environmental Impact Statement -

November 1996” was submitted as part of this licence application.

The CD can be viewed by request at:-

Licensing Unit, Office of Licencing & Guidance,

EPA, P.O. Box 3000

Johnstown Castle Estate, Wexford.

Tel: 053 60600

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(!I NOVARTIS

Office of Licensing and Guidance Environmental Protection Agency PO Box 3000 Johnstown Castle Estate County Wexford

e 07 Nov 2005

IPC10309.doc

Vincent Boyton E + IH Services Manager Health, Safety and Environmental Protection

Novartis Ringaskiddy f?i?hted Ringaskiddy Co. Cork Ireland

Tel +353-21-4862324 Fax +353-21-4862358

Re: Agency Letters of 23-AUP2005 and 05Ott-2005 (Il?CL Register Number 545)

further to the Agency’s letters of 23-Aug-2005 and 05-Ott-2005 and Novartis Ringaskiddy Limited’s reply of 26-Sep-2005 (our reference: IPC10305.doc) requesting the Agency to undertake a review of Integrated Pollution Control Licence (IPCL) Register Number 545 so that it complies with the provisions of Directive 2000/76/EC on the incineration of waste, the company now wishes to submit the information, together with the relevant fee of e 24,758, that was requested by the Agency in its letter of 05-Ott-2005.

An additional submission to the Agency as provided for in Article 16(4) of the EPA (Licensing) Regulations 1994 to 2004 is also being submitted at the same time.

The information is being submitted in the form of one original copy, two hard copies and two ,copies on CD-ROM in .pdf and Word format. An additional three CD-ROMs containing the company’s Environmental Impact Statement of November 1996 - and which had previously been submitted to the Agency - are also included.

It should be noted that much of the information that was requested had previously been lodged with the Agency and this is cross-referenced, where relevant, in the current application form. The key documents that are cross-referenced are:

EMAS YERl”ED ENVIRONMENTAL MANAGEMENT Directors: Mr. R. Brlndli (Swiss), Mr. A. Rummelt (German), Mr. J. Alexander (Irish), Managing. 1RL-oooca2 Registered Office: Ringaskiddy, Co. Cork, Republic of Ireland. Registered in Ireland No. 147396

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(1) NOVARTIS

The company’s original application to the Environmental Protection Agency (EPA) for an Integrated Pollution Control (IPC) 1 icence (dated Ol-Sep-1994); and information requested by the EPA on 31-Mar-2000, 25-May-2000 and 06-Sep-2000 (company references: IPC10194.doc, IPClOlW.doc and IPC1020l.doc respectively) to support a licence review. Additional information was also submitted on 17-Nov-2003 and 15- Jan-2004 (company references: IPCl0252.doc and IPCl0253.doc respectively).

Section 4 of the company’s Environmental Impact Statement of 1996; and the company’s Annual Environmental Reports.

Novartis Ringaskiddy Limited can supply further information (in addition to this information and the company’s separate submission being supplied to meet the requirements of the Agency’s letter of 05-Ott-2005) to the Agency as the review proceeds and as required by the Agency.

If you need any further information or clarification on the above items please do not hesitate to contact the undersigned,

yours sincerely,

&xwi kyJ Vincent Bovton

EMAS “ERlRED ENVIIIONMENTAL Directors: Mr. R. Brlndli (Swiss), Mr. A. Rummelt (German), Mr. J. Alexander (Irish), Managing. MAN(\GEMENT IRL-mm02 Registered Office: Ringaskiddy, Co. Cork, Republic of Ireland. Registered in Ireland No. 147396

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An Ghniomhokacht urn Chaomhnd Comhshaoil

Integrated Pollution Prevention and

Control Licensi

Application Form

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

requirements of the EPA Acts 1992 and 2003.

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

Telephone : 053-60600 Fax : 053-60699

Register 770 Application Form and Attachmentsdoc

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IPPC Application Form

A valid application must contain the information prescribed in the Environmental Protection Agency (Licensing) Regulations, 1994 to 2004. The applicant is strowlv advised to read the Applicntion Guidance Notes for Integrated Pollution Prevention and Control Licensing, available from the EPA.

The applicant must conform to the format set out in the guidance notes for applications (available from the EPA). Each page of the completed application form must be numbered, e.g. page 5 of 45, etc. Also duplicated pages from the application form should be uniquely numbered, e.g. page 5(i) of 45, etc. The basic information should for the most part be supplied in the spaces given in application form and any supporting documentation should be supplied as attachments, as specified. Consistent measurement units must be used throughout.

The applicant should note that the application form has been structured so that it requires information to be presented in an order of progressive detail.

When it is found necessary, additional information may be provided on supplementary attachments which should be clearly cross referenced with the relevant sections in the main document.

While all sections in the application form may not be relevant to the activity concerned, the applicant should look carefully through all aspects of the form and provide the required information, in the greatest possible detail.

All maps/drawings/plans must be no larger than A3 size and scaled appropriately such that they are clearly legible. In exceptional circumstances, where A3 is considered inadequate, a larger size may be requested by the Agency.

Information supplied in this application, including supporting documentation will be put on public display and open to inspection by any person. Should the applicant consider information to be confidential, this information should be submitted in a separate enclosure bearing the legend “In the event that this information is deemed not to be held as confidential, it must be returned to . . . . . . . . “. In the event that information is considered to be of a confidential nature, then the nature of this information, and the reasons why it is considered confidential (with reference to the “Access to Information on the Environment” Regulations) should be stated in the Application Form, where relevant.

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Note: Substantive data has already been submitted to the Environmental Protection Agency (EPA) in respect of the information requested by the EPA in its letter of 05 Ott-2005 to the company. Please refer to the company’s original application for an Integrated Pollution Control (IPC) licence (dated 0 1 -Sep- 1994); and information requested by the EPA on 31-Mar-2000, 25-May-2000 and 06-Sep-2000 (company references: IPCl0194.doc, IPC10197.doc and IPC10201.doc respectively) to support a licence review.

Please refer also to section 4 of the company’s Environmental Impact Statement of 1996; and to the company’s Annual Environmental Reports (where referenced).

Article 10 of the Environmental Protection Agency (Licensing) Regulations, 1994 to 2004 sets out the statutory requirements for information to accompany a licence application. The application form is designed in such a way as to set out these questions in a structured manner and not necessarily in the order presented in Article 10. In order to ensure a legally valid application in respect of Article 10 requirements please complete the following check-list.

Article 10(2)(a) give the name, address and telephone number of the applicant and, if different, any address to which correspondence relating to the application should be sent and, if the applicant is a body corporate, the address of its registered or principal office,

(b) give - (0 in the case of an established activity, the number of

employees and other persons working or engaged in connection with the activity on the date after which a licence is required and during normal levels of operation, or

(ii) in any other case, the gross capital cost of the activity to which the application relates,

LOCATION CHECKED Amlicant 4 1 Official 0

(c) give the name of the planning authority in whose functional area the activity is or will be carried on,

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(d) in the case of a discharge of any trade effluent or other matter (other than domestic sewage or storm water) to a sewer of a sanitary authority, give the name of the sanitary authority in which the sewer is vested or by which it is controlled,

Applicant J 1 Official q

(e) give the location or postal address (including where appropriate, the name of the relevant townland or townlands) and the National Grid reference of the premises to which the activity relates,

(0 specify the relevant class or classes in the First Schedule to the Act to which the activity relates,

LOCATION

CHEUCBD. Applicant d’ 1 Official 0

(g) specify the raw and ancillary materials, substances, preparations, fuels and energy which will be produced by or utilised in the activity, (Note: This data has been included in previous submissions and this is referenced where appropriate in the text of this folm)

) Official 0

(h) describe the plant, methods, processes, ancillary processes, abatement, recovery and treatment systems, and operating procedures for the activity,

LOCATION

CHECKED~ Applicant J I Official 0

(9 indicate how the requirements of section 83(5)(a)(i) to (v) and (vii) to (x) of the Act shall be met, having regard, where appropriate, to any relevant specification issued by the Agency under section 5(3) of the Act and the reasons for the selection of the arrangements proposed,


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(j) give particulars of the source, nature, composition, temperature, volume, level, rate, method of treatment and location of emissions, and the period or periods during which the emissions are made or are to be made, (Note: This data has been included in previous submissions and this is referenced where appropriate in the text of this form)

Applicant X 1 Official [7

(k) describe the arrangements for the prevention or minimisation of waste and, where waste is produced, the on and of site arrangements for the recovery or disposal of solid and liquid wastes, (Note: This data has been included in previous submissions and this is referenced where appropriate in the text of this form)

(1) specify, by reference to the relevant European Waste Catalogue codes as prescribed by Commission Decision 2000/532/EC of 03 May 2000, the quantity and nature of the waste or wastes produced or to be produced by the activity,

(m) provide: (i) details, and an assessment, of the impacts of any existing or

proposed emissions on the environment, including on an environmental medium other than that or those into which the emissions are or are to be made, and

(ii) details of the proposed measures to prevent or eliminate, or where that is not practicable, to limit, reduce or abate emissions,

Applicant 4 1 Official q

(n) identify monitoring and sampling points and outline proposals for monitoring emissions and the environmental consequences of any such emissions,


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(0) describe the condition of the site of the installation, (Note: This data has been included in previous submissions and this is referenced where appropriate in the text of this form)

(p) describe in outline the main alternatives, if any, to the proposals contained in the application which were studied by the applicant, (Note: This data has been included in previous submissions and this is referenced where appropriate in the text of this form)

(q) specify the measures to be taken to comply with an environmental quality standard where such a standard requires stricter conditions to be attached to a licence than would otherwise be determined by reference to best available techniques, (Note: This data has been included in previous submissions and this is referenced where appropriate in the text of this form)

(r) describe the measures to be taken for minimising pollution over long distances or in the territory of other states, (Note: This data has been included in previous submissions and this is referenced where appropriate in the text of this form)

(s) describe the measures to be taken under abnormal operating conditions, including start-up, shutdown, leaks, malfunctions, breakdowns and momentary stoppages, (Note: This data has been included in previous submissions and this is referenced where appropriate in the text of this form)

Applicant X 1 Official 0


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,I :, !..I .~1 “;:, ,./ s:_. a

QL IPPC Application Form

(t) describe the measures to be taken on and following the permanent cessation of the activity or part of the activity to avoid any risk of environmental pollution and to return the site of the activity to a satisfactory state,

(u) describe, in the case of an activity which gives, or could give rise, to an emission containing a hazardous substance which is discharged to an aquifer and is specified in the Annex to Council Directive 80/68/EEC of 17 December 1979 on the protection of groundwater against pollution caused by certain dangerous substances, the arrangements necessary to comply with said Council Directive, (Note: This data has been included in previous submissions and this is referenced where appropriate in the text of this form)

1 LOCATIO;N I I CHECKED

I

Applicant X 1 Official /-J I

(v) include any other information required under Article 6(l) of Council Directive 96/61/EC of 24 September 1996 concerning integrated pollution prevention and control, (Note: This data has been included in previous submissions and this is referenced where appropriate in the text of this form)

,LOCAm?& 'CHEC&D

Applicant X 1 Official 0.

(w) include a non-technical summary of information provided in relation to the matters specified in paragraphs (f) to (v) above, (N’ote: This data has been included in previous submissions and this is referenced where appropriate in the text of this form)

Applicant X ) Official q

(x) state whether the activity consists of, comprises, or is for the purposes an establishment to which the European Communities (Control of Major Accident Hazards involving Dangerous Substances) Regulations, 2000 apply,

q LOC+TION CHECI$ED ‘ Applicant J 1 Official [7

Article lO(3) Without prejudice to Article 12(l), an application for a licence shall be accompanied by -

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(a> a copy of the relevant page of the newspaper in which the notice in accordance with article 6 has been published,

(b) a copy of the text of the site notice erected or fixed on the land or structure in accordance with article 7,

cc> a copy of the notice given to the planning authority under section 85(l)(a) of the Act,

(4 a copy of such plans, including a site plan and location map (no larger than A3), and such other particulars, reports and supporting documentation as are necessary to identify and describe -

(i) the activity

(ii) the position of the site notice in accordance with article 7,

.:%~fX’fJ~N ‘. _;I;_ CHE&&) Applicant 4 1 Official 0

(iii) the point or points from which emissions are made or are to be made, and

Applicant -I’ 1 Official q

(iv) monitoring and sampling points, and

(4 a fee specified in accordance with section 94 of the Act.

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Article 10(4)(b) A signed original and 2 hardcopies of the application and accompanying documents/particulars in hardcopy format plus 2 copies of all files in electronic searchable PDF format on CD- Rom shall be submitted to the headquarters of the Agency.

In cases where an E.I.S. is required to be submitted to the Agency in support of the application, a signed original and 2 hardcopies of the EIS plus 16* copies of all files in electronic searchable PDF format on CD-Rom shall be submitted to the headquarters of the Agency.

* Energy sector applicants = 18 copies

Applicant 4 1 Official q

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SECTION B GENERAL

B.1. Owner/Operator

* Applicants Name: Novartis Ringaskiddy Limited

Address: Ringaskiddy

County Cork

Ireland

Telephone N”-: 021-486000

Fax No: 021-4862358

e-mail: Not applicable

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

Address for correspondence: As above (if different from above)

Address ofBody Corporate: Novartis Ringaskiddy Limited (if applicable)

Ringaskiddy

County Cork

lreland

e-maiZ:Not applicable

The applicant must also supply the following:

(4 Certified Copy of Certificate of Incorporation

Refer to Attachment Number B. 1 and to www.cro.ie (the webpage of the Companies Registration Office

(b) Company’s Number in Company’s Registration Office:

Number 147396

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Particulars of Registered Office of the Company

Novartis Ringaskiddy Limited

Ringaskiddy

County Cork

Ireland

Name and address of the proprietor(s) of the Land on which the Activity is situated (if different from applicant named above).

Not Applicable.

Name and address of the owner(s) of the building and ancillary plant in which the activity is situated (if different from applicant named above).

Not Applicable.

B.2. Location of Activity

Name:

Full Address:

a Telephone iV-:

Fax N”:

Contact Name(s):

Position(s) :

e-mail :

National Grid Reference (12 digit-6E, 6N)

Novartis Ringaskiddy Limited

Ringaskiddy

County Cork

Ireland

021-486000

021-4862358

Vincent Boyton

Enviromnental and Industrial Hygiene Services Manager

[email protected]

176495E 063627N

Location maps, with grid references should be enclosed in Attachment N” B.2.


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Please refer to the company’s original application to the Environmental Protection Agency (EPA) for an Integrated Pollution Control (IPC) licence (dated Ol-Sep-1994); and information requested by the EPA on 31-Mar-2000, 25-May-2000 and 06-Sep-2000 (company references: IPC 10 194.doc, IPC 10 197.doc and IPC 1020 1 .doc respectively) to support a licence review.

Please refer to the company’s Environmental Impact Statement of 1996.

Please refer to the following two drawings, which are included in Attachment Number F.2

Drawing Number Title

000-5 17043-l Rev 0 000-5 17044-l Rev 0

Main Emission Points with Irish Grid Projection Main Sampling and Monitoring Points with Irish Grid Projection

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B.3. Class of Activity

Identify the relevant activities in the First, Third or Fourth Schedule of the POE Act 2004 to which the activity relates:

Schedule Class DescriptionNote ’

Schedule: 1 Class: 5.16 Description: The use of a chemical or biological process for the production of basic pharmaceutical products

Schedule: 1 Class: 11.1 Description: The recovery or disposal of waste in a facility, within the meaning of the Waste Management Act of 1996, which facility is connected or associated with another activity specified in this Schedule in respect of which a licence or a revised licence under Part IV is in force or in respect of which a licence under the said Part is or will be required

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

B.4. Employees/ Capital Cost

Give-

(i) In the case of an established activity, the number of employees and other persons, working or engaged in connection with the activity on the date after which a licence is required and during normal levels of operation, or

412 Employees (Note that the company has been issued with an IPC licence by the Agency - Register Number 545)

(ii) In any other case, the gross capital cost of the activity to which the application relates.

Number of Employees (existing facilities) : 412

Gross Capital Cost (new proposals) : Not Applicable

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B.5. Relevant Planning Authority

Give the name of the planning authority in whose functional area the activity is or will be carried out.

Name: Cork County Council

Address: Planning Department

Model Farm Road

Cork

Telephone N”-: 0214867006

Planning Permission for this project:-

Obtained J Is beingprocessed Not appliedfor

Local Authority Planning File Reference N”-: S/2989/89

Attachment Ng B.5 should contain all planning permissions including a copy of all conditions. For existing activities, Attachment N” B.5 should also contain all licences and permits past and present in force at the time of submission.

Please refer to the company’s original application to the Environmental Protection Agency (EPA) for an Integrated Pollution Control (IPC) licence (dated Ol-Sep-1994); and information requested by the EPA on 3 l-Mar-2000, 25-May-2000 and 06-Sep-2000 (company references: IPC 10194.doc, IPCl 0197.doc and IPC 1020 1 .doc respectively) to support a licence review.


The company is currently regulated by the Environmental Protection Agency under IPC Licence Register Number 545 and Greenhouse Gas Permit Number 078

The till list of planning permission granted by Cork County Council is as follows:

PLANNING FILE NUMBER S/2989/89

DEVELOPMENT DESCRIPTION

Erection of pharmaceutical manufacturing facility at Raheens, Barnahely, Shanbally, Ringaskiddy Co. Cork

DEVELOPMENT STATUS Complete

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s/713/91 S/92/3499

s/93/3559

s/95/41 52

S/96/2000

S/96/40 15

S/98/4089

S/00/5078

S/02/5666

Administration Building (change of plan) Extensions to Tech Services, Utilities, Tank Farm Control, East/West Corridor, Warehouses and Administration Building, Plantroom Space and Sign Alterations and extension to East West Corridor and change of use of Main Warehouse Mezzanine to provide Office Accommodation Alterations and change of use of dwelling to snorts club chaneinn rooms Construction of single storey extension adjoining the North end of Multipurpose Synthesis Plant (MSP) building to house freeze drvers and associated eauioment Construction of new process building and additions to synthesis annex, solvent recoverv and additional facilities Construction of single storey Administration and Laboratory building and provision of 90 no. additional car parking snaces Construction of single storey extension to waste water treatment control building for use as Tea Break Area Construction of extension to PB2 production building and a new product finishing/warehouse building

Complete Complete

Complete

Complete

Complete

Planning permission valid until 3 1 January 2007 Complete

Complete

Planning permission valid until 18 February 20 13

Notes:

Planning Register Reference Number S/2989/89 is not the most recent planning permission granted for the facility at Novartis Ringaskiddy Limited. However, it constitutes the main planning permission for the site.

It is permissible to develop a building in phases, provided there is a commitment to complete the development within the period of the permission.

Drawing Number 000-121006 is the Site Layout drawing and shows existing structures and titure structures for which planning permission has been obtained. An amlnual update to this drawing is provided in the company’s Annual Enviromnental Report to the Agency

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B.6. Relevant Sanitary Authority.

In the case of a discharge of any trade effluent or other matter to a sewer of a sanitary authority, give the name of the sanitary authority in which the sewer is vested or by which it is controlled.

Name: Cork County Council

Address: Environment Section

Room 708

County Hall

Cork

Telephone N”-: 0214276891

In the case of a discharge of any trade effluent or other matter to a sewer not vested by a sanitary authority, the applicant must supply as Attachment NG B.6; (a) the name and address of the owner(s) of the sewer and the waste water treatment plant to which the sewer discharges and who are responsible for the quality of the treated effluent discharging to waters and (b) a copy of the effluent regulations and the agreement between the applicant and the aforementioned.

Not Applicable.

B.7. Relevant Health Board Region

The applicant should indicate the Health Board Region where the activity is or will be located.

Name: Health Service Executive Cork and Kerry

Address: Administrative Headquarters

W ilton Road

Cork

Telephone N”-: 021 4545011

B.S. Site Notice, Newspaper Advertisement and Planning Authority Notice.

Give the position of the site notice in accordance with article 7 of the Regulations.

j

‘,

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The site notice was printed and affixed, on a durable material and was securely erected and fixed in two conspicuous positions - at the main entrance to the facility from the main public road to the South of the facility; and also at the secondary entrance to the facility from the secondary public road to the North of the facility. Refer also to the map in Attachment Number B.S.

Attachment NG B.8 should contain a copy of the text of the site notice, a map showing its location on site and a copy of the newspaper advertisement. A copy of the notice given to the Planning Authority should also be included.

B.9 Seveso II Regulations

l State whether the activity is an establishment to which the EC (Control of Major Accident Hazards involving Dangerous Substances) Regulations, 2000 (S.I. No. 476 of 2000) apply*

In 2000, the Statutory Instrument S.I. No. 476 of 2000 “European Communities (Control of Major Accident Hazards involving Dangerous Substances) Regulations, 2000” was issued. This implemented the provisions of Council Directive 96/82/EC on the Control of Major Accident Hazards Involving Dangerous Substances - the so-called “Seveso II Directive”.

Statutory Instrument No. 476 of 2000 introduced additional requirements aimed at preventing and limiting the effects of accidents arising from industrial activities involving dangerous substances, which had been the subject of a previous regulation - . S.I. No. 292 of 1986 “European Communities (Major Accident Hazards of Certain Industrial Activities) Regulations, 1986. S.T. No. 476 of 2000 defines both the dangerous substances and the categories of industrial activities covered by its provisions.

l Novartis Ringaskiddy Limited falls into the category of industrial activities covered, but the quantities of materials stored currently do not exceed the threshold levels at which the more serious provisions of the regulations come into force. Consequently the company has prepared a Major Accident Prevention Policy (MAPP) document, which was finalised towards the end of 2001 and forwarded to the relevant competent body in the State, the Health and Safety Authority (HSA). The MAPP document has already been submitted to the EPA as part of the company’s Annual Environmental Report for 2002.

If yes, outline how the process comes under these regulations.

The company’s material inventory includes materials within the Categories 7(b) (Highly flammable liquids); and 9 (i) and 9 (ii) (Dangerous for the (aquatic) environment) - principally the solvent Cyclohexane.

Supporting information should be included in Attachment NC B.9.


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Specifjr whether the facility is a category of industrial activity referred to in Annex I of the IPPC Directive (96/61/EC) and if yes specify the category.

Category 4.5 Installations using a chemical or biological process for the production of basic pharmaceutical products.

Category 5.1 Installations for the disposal or recovery of hazardous waste as defined in the list referred to in Article 1 (4) of Directive 91/689/EEC, as defined in Annexes II A and II B (operations RI, R5, R6, R8 and R9) to Directive 75/442/EEC and in Council Directive 75/439/EEC of 16 June 1975 on the disposal of waste oils, with a capacity exceeding 10 tonnes per day.

Supporting information should be included in Attachment N” B.lO.

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IPPC Adication Form

$EcTJdN C B!IjUfAGEjVlENT OP THE INSTALLATION

C.l Site Management & Control

Details should be provided on the management structures for the activity. Organisational charts, and all relevant environmental management policy statements, including provisions for on-going assessment of environmental performance are required.

Please refer to the company’s original application to the Environmental Protection Agency (EPA) for an Integrated Pollution Control (IPC) licence (dated 01-Sep-1994); and to the annual Environmental Management Programmes, which have been submitted to the Agency since 1994; and the Annual Environmental Reports, which have been submitted to the Agency since 2000.

The most recent organisation charts for the company; and for the two functions involved in environmental protection - Health, Safety and Environmental Protection and Technical Services are included in Attachment Number L. The qualifications of the key personnel are outlined in the sub-section ‘f-it and proper person’ in section L of this application form.

Indicate whether an Environmental Management System has been developed for the installation.

Yes.

If yes, specify which standard and include a copy of the accreditation certificate.

The company has been accredited under the Eco Management and Audit Scheme since 1 S-Dee-1996. The company’s registration number is IE-S-002; the current accreditation certificate was received in a framed format from the Irish National Accreditation Board and cannot be copied in its current format.

A copy of the company’s most recent Interim Environmental Statement for 2004 and Environmental Statement for 2001 to 2003 is included in Attachment Number C. A copy of the company’s Health, Safety and Environmental Policy is included in both documents.

This information should form Attachment N2 C.

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gEC’rI(iN a. INFRASTRIkTURiZ &. QPERATIO7$

D.l. Operational Information Requirements

Please refer to the company’s original application to the Environmental Protection Agency (EPA) for an Integrated Pollution Control (IPC) licence (dated 01-Sep-1994); and information requested by the EPA on 31-Mar-2000, 25-May-2000 and 06-Sep-2000 (company references: IPC 10194.doc, IPCl 0197.doc and IPC 1020 1 .doc respectively) to support a licence review.


Describe the plant, methods, processes, ancillary processes, abatement, recovery and treatment systems, and operating procedures for the activity, to include a copy of such plans, drawings or maps, (site plans and location maps, process flow diagrams), and such other particulars, reports and supporting documentation as are necessary describe all aspects of the activity.

A development and operational history of the site should be included here.

Attachment N” D should contain a list of all unit operations (process) to be carried out, including flow diagrams of each with any relevant additional information.

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SECTION E EMXSSIONS

Please refer to the company’s original application to the Environmental Protection Agency (EPA) for an Integrated Pollution Control (IPC) licence (dated 01 -Sep-1994); and information requested by the EPA on 31-Mar-2000, 2%May-2000 and 06-Sep-2000 (company references: IPC 10194.doc, IPCI 0197.doc and IPC 1020 1 .doc respectively) to support a licence review.

E.l. Emissions to Atmosphere

E. 1 .A. Details of all point emissions to atmosphere

Details of all point emissions to atmosphere should be supplied. Table E. 1. (i) (for Boiler emissions) must be completed for boilers over 20MW thermal input. Complete Table E.l (ii) and E.l (iii) for all other main emission points. Complete Table E. 1 (iv) for minor emission points.

A summary list of the emission points, together with maps, drawings, and supporting documentation should be included as Attachment N” E. Plans of emission elevations, relevant roof heights, etc., should also be included, as should detailed descriptions and schematics of all abatement systems.

The applicant should address in particular any emission point where the substances listed in Schedule of S.I. 394 of 2004 are emitted.

For emissions outside the BAT guidance limit, a full evaluation of the existing abatement/treatment system must be provided. A planned programme of improvement towards meeting upgraded standards is required. This should highlight specific goals and a time scale, together with options for modification, upgrading or replacement as required to bring the emissions within the limits as set out in the BAT guidance note(s).

E. 1 .B. Fugitive and Potential emissions.

Give summary details of fugitive and potential emissions in Table E. 1 (v).

In relation to activities listed in the Schedule of Council Directive 1999/13/EC on the limitation of emissions of volatile organic compounds due to the use of organic solvents in certain activities and installations; - specify the relevant category of activity in the Schedule - specify how the requirements in relation to fugitive emissions will be met.

Full details and any supporting information should form Attachment E.l.B


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E.2 Emissions to Surface Waters

Tables E.2 (i) and E.2 (ii) must be completed.

A summary list of the emission points, together with maps, drawings and supporting documentation should be included as Attachment Ng E.2.

The applicant should address in particular any emission point where the substances listed in the Schedule of S.I. No. 394 of 2004 are emitted.

Details of all List I and List II substances listed in the Annex to EU Directive 76/464/EEC (as amended), contained in any emission must be presented. All surface water runoff and storm water drains discharging to surface water bodies must be included. A National Grid References (10 digit, 5E, 5N) must be given for all discharge points. The identity and type of receiving water (river, ditch, estuary, lake, etc.) must be stated.

For emissions outside the BAT guidance limit, a full evaluation of the existing abatement/treatment system must be provided. A planned programme of improvement towards meeting upgraded standards is required. This should highlight specific goals and a time scale, together with options for modification, upgrading or replacement as required to bring the emissions within the limits as set out in the BATNEEC guidance note(s).

E.3 Emissions to Sewer

Tables E.3 (i) and E.3 (ii) should be completed.

A summary list of the emission points, together with maps, drawings and supporting documentation should be included as Attachment NG E.3. Details of all List I and List II substances listed in the Annex to EU Directive 76/464/EEC (as amended), contained in any emission must be presented. All relevant information on the receiving sewer, including any effluent treatment/abatement systems, not already described, with schematics as appropriate should also be included in Attachment NLE.3.

For emissions outside BAT guidance limit (where given), a full evaluation of the existing abatement/treatment system must be provided. A planned programme of improvement towards meeting upgraded standards is required. This should highlight specific goals and a time scale, together with options for modification, upgrading or replacement as required to bring the emissions within any limits set out in the BAT guidance note(s).

E.4. Emissions to Ground

Describe the existing or proposed arrangements necessary to give effect to Articles 3,4,5,6, and 7 of Council Directive 80/68/EEC of 17 December 1979 on the protection of groundwater against pollution by certain dangerous substances.


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The applicant should supply details of the nature and quality of the substance (agricultural and non-agricultural waste) to be landspread (slurry, effluent, ash, sludges etc) as well as the proposed application rates, periods of application and mode of application (e.g., pipe discharge, tanker).

For emissions outside the BAT guidance limit, a full evaluation of the existing abatement/treatment system must be provided. A planned programme of improvement towards meeting upgraded standards is required. This should highlight specific goals and a time scale, together with options for modification, upgrading or replacement as required to bring the emissions within the limits as set out in the BAT guidance note(s).

ES Noise Emissions

Give particulars of the source, location, nature, level, and the period or periods during which the noise emissions are made or are to be made.

Table ES(i) should be completed, as relevant, for each source.

Supporting information should form Attachment N” E.5

For emissions outside the EPA Noise Guidance Note limit, a full evaluation of the existing abatement/treatment system must be provided. A planned programme of improvement towards meeting upgraded standards is required. This should highlight specific goals and a time scale, together with options for modification, upgrading or replacement as required to bring the emissions within the limits as set out in the guidance note.

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IPPC Abdication Form

SECTION F CONT.F$)L & MONITORING

Describe the proposed technology and other techniques for preventing or, where this is not possible, reducing emissions from the installation/facility.

F.l: Treatment, Abatement and Control Systems

Details of treatment/abatement systems (air and effluent emissions) should be included, together with schematics as appropriate.

For each Emission Point identified complete Table F.l (i) and include detailed descriptions and schematics of all abatement systems.

Please refer to the company’s original application to the Environmental Protection Agency (EPA) for an Integrated Pollution Control (IPC) licence (dated 0 1 -Sep-1994); and information requested by the EPA on 31-Mar-2000, 25-May-2000 and 06-Sep- 2000 (company references: IPC10194.doc, IPC10197.doc and IPC10201.doc respectively) to support a licence review. Additional information can also be found in the company’s letters of 17-Nov-2003 and 15-Jan-2004 (company references: IPC10252.doc and IPC10253.doc respectively).

With specific reference to Article 4(2) (a) of 2000/76/EC -

The company has previously submitted the required information to the Agency:

Please refer to the company’s original application to the Environmental Protection Agency (EPA) for an Integrated Pollution Control (IPC) licence (dated 0 1 -Sep- 1994); and information requested by the EPA on 3 1 -Mar-2000, 25-May-2000 and 06-Sep-2000 (company references: IPC 10194.doc, IPC10197.doc and IPC10201.doc respectively) to support a licence review. Additional information was also submitted on 17-Nov-2003 and 15-Jan-2004 (company references: IPC 10252.doc and IPC 10253.doc respectively).

With specific reference to Article 4(2) (b) of 2000/76/EC -

Heat is recovered in the form of steam in the Liquid Vapour Incinerator but is not in the Solid Waste Incinerator because of its relatively small size. The latter incinerates waste material at an input weight of less than 200 kg/hour - and only operates periodically. Consequently heat recovery is not viable with this unit.

With specific reference to Article 4(2) (c) of 2000/76/EC - there are three residual streams arising Erom incineration activities:

The Liquid Vapour Incinerator has a quench and scrubber liquid effluent that is currently discharged to emission point reference number W 1.

The Solid Waste Incinerator generates two residual streams: Bottom ash and slag, which is land filled, from the primary stage of combustion; and Spent lime and


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activated carbon, which is currently thermally treated or reused, from flue gas cleaning.

Minimisation of effluent from incineration activities was the subject of a specific objective and target in Schedule 5 (i) of the company’s current Integrated Pollution Control Licence. The combined quench and scrubber discharge from the Liquid Vapour Incinerator has been optimised as required.

The company has received permission from the Agency ( ) for off-site treatment and/or reuse of the mixture of spent lime and activated carbon generated during flue gas cleaning in the Solid Waste Incinerator. Heretofore this material was returned for incineration of the carbon fraction in the Solid Waste Incinerator with the lime fraction being isolated in the bottom ash and slag from the primary stage of combustion.

Bottom ash and slag is currently landfilled but the company will be evaluating the possibility of removing metal (typically metal rings) from this material to allow recycling of the metal; and possible reuse of the remaining inert residues.

With specific reference to Article 4(2)(d) of 2000/76/EC -

The permit shall be granted only if the application shows that the proposed measurement techniques for emissions into the air comply with Annex III and, as regards water, comply with Annex IIIparagraphs I and 2.

ANNEX III

Measurement techniques

1. Measurements for the determination of concentrations of air and water polluting substances have to be carried out representatively.

Continuous sampling and monitoring is used for analysis of emissions to air as outlined in Table F2 (i) of this application form.

A sampling valve is located at Emission Point Reference Number Wl (discharge from quench and scrubber of Liquid Vapour Incinerator). This will be upgraded to make provision for a composite sampler.

2. Sampling and analysis of all pollutants including dioxins and furans as well us reference measurement methods to calibrate automated measurement systems shall be carried out as given by CEht-standards. If CEN standards are not available, IS0 standards, national or international standards which will ensure the provision of data qf an equivalent scientific quality shall apply.

Continuous sampling and analysis of all pollutants to atmosphere is to the standards as outlined in Attachment Number F.2 of this application form (refer to SlRA Product Conformity Certificate and TUV Certificate).

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.a Q.L IPPC Application Form

All other sampling and analysis of pollutants to atmosphere or to water shall be carried out as given by CEN-standards. If CEN standards are not available, IS0 standards, national or international standards which will ensure the provision of data of an equivalent scientific quality shall apply.

3. At the daily emission limit value level, the values of the 95 % confidence intervals of a single measured result shall not exceed the following percentuges of the emission limit values:

Curhon monoxide: 10 % Sulphur dioxide: 20 % Nitrogen dioxide: 20 % Total dust: 30 % Total organic carbon: 30 % Hydrogen chloride: 40 % Hydrogen fluoride: 40 %.

Refer to copies of SIRA Product Conformity certificate and TUV Certificate in Attachment Number F.2 of this application form.

With specific reference to Article 4(5) (a) and (b) of 2000/76/EC -

Attachment Number H.l of this application form contains a listing of waste types for on-site incineration (in the format of Schedule 3 (ii) of IPC License Register Number 545). This lists the waste types which are currently treated in the Solid Waste Incinerator and the Liquid Vapour Incinerator together with their minimum and maximum flows; and their minimum and maximum calorific values.

The Liquid Vapour Incinerator incinerates solvent waste with an organohalogen content of < 1%.

The Solid Waste Incinerator incinerates solid waste with an organohalogen content of < 1%.

Metals are not used in production processes at Novartis Ringaskiddy Limited - although provision has been made in the company’s current IPC license for the use of copper.

PCB and PCP are not incinerated at Novartis Ringaskiddy Limited.

Attachment NQ F.l should contain any supporting information.

Attachment Number F.l contains copies of the following drawings together with an overview of the unit processes in the Solid Waste Incinerator and the Liquid Vapour Incinerator


574-20038 1 Rev 2 Solid Waste Incinerator (Combustion)


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IPPC Aadication Form

574-200382 Rev4 Solid Waste Incinerator (CDAS Flue Gas Cleaning System)

572-200381-l Rev16 572-200381-2 Rev 15 572-200382-l Rev 0 572-200120 -1 Rev 10 System) 572-200380-l Rev 10 572-200380-2 Rev 8

Liquid Vapour Incinerator (Combustion Unit 1) Liquid Vapour Incinerator (Combustion Unit 2) Liquid Vapour Incinerator (RVT Module) Liquid Vapour Incinerator (Quench and Scrubber

Liquid Vapour Incinerator (Steam Generating Unit) Liquid Vapour Incinerator (Steam Generating Unit - Sootblower)

F.2: EMISSIONS MONITORING AND SAMPLING POINTS

Identify monitoring and sampling points and outline proposals for monitoring emissions. Table F.2 (i) should be completed (where relevant) for air emissions, for emissions to surface waters, for emissions to sewers, for emissions to ground, and for waste emissions. Where ambient environment monitoring is carried out or proposed, Table F.2 (ii) should be completed as relevant for each environmental medium.

Include details of monitoring/sampling locations and methods.

Please refer to the company’s original application to the Environmental Protection Agency (EPA) for an Integrated Pollution Control (IPC) licence (dated Ol-Sep-1994); and information requested by the EPA on 3 l-Mar-2000, 25-May-2000 and 06-Sep- 2000 (company references: IPC10194.doc, IPC10197.doc and IPC10201.doc respectively) to support a licence review. Refer also to Integrated Pollution Control Licence Register Number 545.

Please refer also to table F (i) of this application form; and to Attachment Number F2, which contains details on the FTIR spectroscopic system that is used for continuous monitoring of the following parameters in the flue gases of the Solid Waste Incinerator and the Liquid Vapour Incinerator: H,O, O,, CO, SO,, VOC, HCl, and NOx.

Attachment NC F.2 should contain any supporting information.

Attachment Number F.2 contains copies of the following drawings:


000-517043-l Rev 0 000-517044-l Rev 0

Main Emission Points with Irish Grid Projection Main Sampling and Monitoring Points with Irish Grid Projection

Attachment Number F.2 also contains the document titled ‘Multi-component Analyser System ACF-NT’


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‘SE;c,TioN G RESO%RCE rjS% AND ENERGY EFtiICIENCY

Please refer to the company’s original application to the Environmental Protection Agency (EPA) for an Integrated Pollution Control (IPC) licence (dated Ol-Sep-1994); and to the annual Environmental Management Programmes, which have been submitted to the Agency since 1994; and the Annual Environmental Reports, which have been submitted to the Agency since 2000.

Please refer to the copy of the energy audit report prepared by Enviros Consulting Limited of Manchester, which was included in the AER for 2002 and which has already been submitted to the EPA.

Please refer to the annual energy reports, which form part of the company’s Amutal Environmental Report (AER), for the years 2001 to 2004 and which have already been submitted to the EPA.

G.1 Give a list of the raw and ancillary materials, substances, preparations, fuels and energy which will be produced by or utilised in the activity.

The list(s) given should be very comprehensive, aJ materials used, fuels, intermediates, laboratory chemicals and product should be included.

Particular attention should be paid to materials and product consisting of, or containing, dangerous substances as described in the EU (Classification, Packaging, Labelling and Notification of Dangerous Substances) Regulations 1994 [SI 77/94]. The list must classify these materials in accordance with Article 2 of these Regulations, and must specify the designated Risk Phrases (R-Phrases) of each substance in accordance with Schedule 2 of the Regulations

Tables G. 1 (i) and G. 1 (ii) must be completed. Copy as required.

Supporting information should be given in Attachment Ng G.

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‘.: , ,

,$E(=TZON H MATERIALS HANDLING

Please refer to the company’s original application to the Environmental Protection Agency (EPA) for an Integrated Pollution Control (IPC) licence (dated Ol-Sep-1994); and to the annual Environmental Management Programmes, which have been submitted to the Agency since 1994; and the Annual Enviromnental Reports, which have been submitted to the Agency since 2000.

Please refer to the supplementary information included in Attachment Number H. 1.

H.l Raw Materials, Intermediates and Product Handling All materials should be listed in Tables G.1 (i) and G. (ii) of Section G.

Details of the storage conditions, location within the site, segregation system used and transport systems within the site should be outlined here. In addition, information relating to the integrity, impermeability and recent testing of pipes, tanks and bund areas should be outlined.

H.2 Describe the arrangements for the recovery or disposal of solid and liquid wastes accepted into or generated by the installation/facility.

For each waste material, give full particulars of;

(a) Name

(b) Description & nature of waste

cc> s ource

(d) Where stored and integrity/impermeability of storage areas

(e) Amount (m3) and tonnage

(f) Period or Periods of generation

(g) Analysis (include test methods and Q.C.)

(h) European Waste Catalogue Code

(i) Waste Category per EC Reg 1774/2002/EC where relevant

Where any waste would be classified as Hazardous Waste as defined in the Waste Management Acts, 1996 to 2003, this should be made clear in the information provided.

Summary Tables H.l (i) and H. 1 (ii) should also be completed, as appropriate, for each waste. The licence/permit register number of the waste collection agent or


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disposal/recovery operator should be supplied as well as the expiry date of the relevant permits.

Supporting information should form Attachment Ng H.1

H.2 Waste disposal by on-site landfilling.

Not Applicable.

For wastes to be disposed of by landfilling on-site, full details of the disposal site should be submitted (to include inter aha, site selection procedures, location maps, geology, hydrogeology, operational plan, containment, gas and leachate management, post-closure care).

Supporting information should form Attachment N9 H.2.

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Documents

CD Placeholder - Environmental Protection Agency · IPPC Application Form A valid application must contain the information prescribed in the Environmental Protection Agency (Licensing)