pharma plant allergan - register of odc containing ... · plh - 4gkhsb r22 4.5kgs annual whiriskey...

Allergan Pharmaceuticals Ireland

Unit Ref Model Gas Charge QuantityLeak Check Requirement Vendor/ Service

Ground FloorAC 1. MSC - 09RV E2 R22 0.8kg Not applicable WhiriskeyAC 2. SLZ - KA25 VAL R410 0.9kg Not applicable WhiriskeyAC 3. MSC - 09RV E2 R22 0.8kg Not applicable WhiriskeyAC 4. MSH - 07NV R22 0.85kg Not applicable WhiriskeyAC 5. PLH - 4GKHSB R22 4.5kgs Annual WhiriskeyAC 6. PLH - 4GKHSB R22 4.5kgs Annual WhiriskeyAC 7. PKA - RP100 FAL R410 5kgs Annual WhiriskeyAC 8. PLA - RP100AAZ R410 5kgs Annual WhiriskeyAC 9. SLZ - KA25A R410 0.9kg Not applicable WhiriskeyAC 10. SLZ - KA25A R410 0.9kg Not applicable WhiriskeyAC 11. SLZ - KA25A R410 0.9kg Not applicable WhiriskeyAC 12. PLH - 1.6 R22 2.2kgs Not applicable WhiriskeyAC 13. PLH - 1.6 R22 2.2kgs Not applicable WhiriskeyAC 14 PUH - 7ap100va R410A 3kgs Annual WhiriskeyAC 15. MSZ - GA35VA R410 1.2kgs Not applicable WhiriskeyAC 16. MSH - 09 LV R22 0.75kgs Not applicable WhiriskeyAC 17. MSH -17 BV R22 1.7kgs Not applicable WhiriskeyAC 18. MSC - A07YV R410 1.3kgs Not applicable WhiriskeyAC 19. MSC - C12TV E1 R407C 1.4kgs Not applicable WhiriskeyAC 20. MLH - 12AV E1 R22 1.4kgs Not applicable WhiriskeyAC 21. MEH - 17AVE1 R22 1.7kgs Not applicable WhiriskeyAC 22. MEH - 17AVE1 R22 1.7kgs Not applicable WhiriskeyAC 23. PLH 1.6 R22 2.2kgs Not applicable WhiriskeyAC 24. MSZ-GE35VA R410A <3kgs Not applicable WhiriskeyAC 25. MSZ-GE35VA R410A <3kgs Not applicable WhiriskeyAC 26. PEAD - RP125EA R410 4.5kgs Annual WhiriskeyAC 28. MSC - 12 RV E1 R22 1.5kgs Not applicable WhiriskeyAC 29. MSH - 128V R22 1.4kgs Not applicable WhiriskeyAC 30. MSC - 12RV E4 R22 1.4kgs Not applicable WhiriskeyAC 31. MSC - 12BV R22 1.2kgs Not applicable WhiriskeyAC 32. PKH - 1.6FKHA R22 1.4kgs Not applicable WhiriskeyAC 33. MSH C18TV E1 R407C 1.6kgs Not applicable WhiriskeyAC 34. PKH - 1.6 KHA R22 1.4kgs Not applicable WhiriskeyAC 35. MUZ - GB50 VA E1 R410 1.5kgs Not applicable WhiriskeyAC 36. MSH - 12LVE1 R22 1.2kgs Not applicable WhiriskeyAC 37. PLH - 1.6KKHB R22 2.2kgs Not applicable Whiriskey

Pharma Plant Allergan - Register of ODC containing equipment

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AC 38. PEAD - RP35EA R410 2.5kgs Not applicable WhiriskeyAC 39 PLH - 1.6KKB R22 2.2kgs Not applicable WhiriskeyAC 40. PLA RP 125AA R410 5kgs Annual WhiriskeyAC 41. PEAD 1.6 KHA R22 2.2kgs Not applicable WhiriskeyAC 42. PKARP 353N AL R410 2.5kgs Not applicable WhiriskeyAC 43. PUHZ RP35VHAZ R410 2.5kgs Not applicable WhiriskeyAC 44. SLZ - KA 35VAL R410 1.05kgs Not applicable WhiriskeyAC 45. MSZ - GA 35VA E2 R410 0.85kgs Not applicable WhiriskeyAC 46. PLA - PZKA R407C 2.6kgs Not applicable WhiriskeyAC 47. PEAD RP125 EA R410 5kgs Annual WhiriskeyAC 48. PLH - 2GKHV R22 2.4kgs Not applicable WhiriskeyAC 49. PLH - 2GKHV R22 2.4kgs Not applicable WhiriskeyAC 50. PLH - 2GKHV R22 2.4kgs Not applicable WhiriskeyAC 51. PLH - 1.6 KKHB R22 2.2kgs Not applicable WhiriskeyAC 52. PUHZ - RP60 VHAZ R410 3.6kgs Security Hut Annual WhiriskeyAC 53. SUZ - KA35VD R410 1.05kgs Not applicable WhiriskeyAC 54. SUZ - KA 35VA R410 1.05kgs Not applicable WhiriskeyAC 55 MSZ-GBSOVA R410 1.5 WhiriskeyAC 56. PKFY-P32VGMS R410 Not applicable WhiriskeyAC 57. PKFY-P32VGMS R410 Not applicable WhiriskeyAC 58. PKFY-P32VGMS R410 Not applicable WhiriskeyAC 59. PKFY-P32VGMS R410 Not applicable WhiriskeyAC 60 MUZ-GE35VA R410A 1.15kgs Not applicable WhiriskeyAC 61 MUZ-GE35VA R410A 1.15kgs Not applicable WhiriskeyAC 62 MUZ-GE25A R410 1.15KGAC 63 MUZ-GE35A R410 1.15KGAC 64 MUZ-GE35A R410 1.15KGAC 65 R410 1.15KGAC 66 MUZ-GE35A R410 1.15KGAC 67 SLZ-KA35 R410A 1.05kg Not applicable Whiriskey Ceiling casstte air conditioning unit

AC 68 MSZ-GE25 R410A 0.8kg Not applicable Whiriskeyold unit removed new air conditioning unit msz-ge25 peter o'donnells office

AC 69 MSZ-GE25 R410A 1.15kg Not applicable Whiriskey Unitdose supervisors officeAC 70 PKA-RP100 R410A 3kg Annual Whiriskey Allergan data room air conditioning unitAC 71 PKA-RP100 R410A 3kg Annual Whiriskey Allergan data room air conditioning unitAC 72 PLA-RP50 R410A 2.5kg Not applicable Whiriskey Air conditioning unit engineering departmentAC 73 MSZ-GE35 R410A 1.15kg Not applicable Whiriskey Unitdose brendan o'malleys officeAC 74 MSZ-GE35 R410A 1.15kg Not applicable Whiriskey Unitdose paper officeAC 75 MUZ-GE25A R410A 0.8kg Not applicable Whiriskey Procurement office 2

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AC 76 MUZ-GE25A R410A 0.8kg Not applicable Whiriskey Procurement office 1

AC 77 MUZ-GE25A R410A 0.8kg Not applicable Whiriskey compliance office

AC 78 PURY-P750YSJM- A R410A 23.6kg Annual Whiriskey Innovation centre

CanteenEquipment Model Gas Charge Quantity Leak Check C1. Display AEZ94402 404A 1.35kg Not applicable WhiriskeyC2. Display CAJ9510 R22 1.6kg Not applicable WhiriskeyC3. Dairywall 4' Arneg J9226GK R404A 1.1kg Not applicable WhiriskeyC4. Dairywall 6' Arneg J9232GK R404A 1.6kg Not applicable WhiriskeyC5. Single Door Gram R134A 600g Not applicable WhiriskeyC6. Blast Chiller Tecnomac R404A 25g Not applicable WhiriskeyC7. Bench Fridge Fagor MFP-135 R134A 360g Not applicable WhiriskeyC8. Freezer K1270/L427 Recor. R404A 220volts WhiriskeyC9. Freezer K600 R134A Whiriskey

TF2a- Ingersoll Rand RS90 R22 2.5kg Not applicable No/a TF2b - Ingersold Rand Drier no. 2 TMS150 R22 2.5kg Not applicable No/a TF2c - ECKO Air Drier no.3 KR110 R22 4.1kg Annual No/a

TF3a - Atlas Copco FD140 ZT160VSD No.7 R410a 2.7kg Not applicable Atlas CopcoTF3b -. Atlas Copco ZT160VSD R404a 8kg Annual Atlas CopcoTF3c - Atlas Copco ZT160VSD R134a 4.3kg Annual Atlas CopcoTF3d - Ingersoll Rand Drier no.4 TMS80E R22 2kg Not applicable No/a TF3e - Ingersoll Rand SSRMH30 R22 2.5kg Not applicable No/a TF3f - Chiller 10 YorkYKNCNCH15 R134A 800kg Quarterly Johnson ControlTF3g - Chiller 11 York 55526LK R134A 800kg Quarterly Johnson ControlTF3h - Chiller 12 York JKNCNCH2 R134A 800kg Quarterly Johnson ControlTF3i - Chiller 13 York YDHD-5700 R134A 800kg Quarterly Johnson Control

Technical Floor 3

Technical Floor 2

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Air DriersTF5. Ingersoll Rand TSS80 R22 2kg Not applicableLabsLabs #1 Euro M500 CXH T C 5S R134A <3kg Not applicable WhiriskeyMicro Plant Room Chill Room J622 R134A Not applicable Whiriskey

New plant for micro compounding coldroom kirby aws4-mgb54 old plant removed R404A 6kg Not applicable WhiriskeyLabs Write Up - HVAC Condensers X 2 R407C 2 Circuits (13kg & 15kg)Annual Johnson ControlLabs ETC Sanyo Freezer R134A <3kg Not applicableCompounding Compounding refrigerators Room 44 #1 R134A 215G Not applicable No/aCompounding refrigerators Room 44 #2 R134A 215G Not applicable No/aFreezer compounding cage Gram RF1400CG R404A 280g Not applicable WhiriskeyFreezer 1 compounding cage Gram BioPlus RF1400 R404A 220g Not applicable WhiriskeyFreezer 2 compounding cage Gram BioPlus RF1400 R404A 220g Not applicable WhiriskeyPlasticsDrier No 8 TMS5225 No/a No/a No/a No/AWarehouseOven 13 Sanyo ETC Oven No/a No/a No/aIncubator 21 Votsch VC0150 R404A 0.9kg No/aOven 22 Weiss Gallenkamp PSR-D R134A 3.7kg AnnualOven 23 Weiss Gallenkamp PSR-D R134A 3.7kg AnnualOven 24 Weiss Gallenkamp PSR-D R134A 3.7kg AnnualOven 25 Weiss Gallenkamp PSR-D R134A 3.7kg AnnualOven 26 Weiss Gallenkamp PSR-D R134A 3.7kg AnnualLumigan Freezer #1 >3kg No/aLumigan Freezer #2 >3kg No/aIncubator 27 Votsch VC4150 R404a 4.2kg AnnualIncubator 28 Votsch VC4150 R404a 4.2kg AnnualETC Freezer_01 Liebherr Profi Line R404A 0.9kg No/AETC Sanyo Biomedical Freezer Sanyo R134A >3KG No/ACold Store - Pharma Warehouse R404a 4KG No/AOtherInterlevin AF07TN chill AF07TN R410A 210g Not applicable WhiriskeyMobile refrigerated container at Pharma receiving dockNo/a R404A 6.3kg Not applicable No/a

Technical Floor 5

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One of the specific requirements of the Regulation is to carry out periodic leak checking of equipment containing F-Gases, the frequency depending on the quantity of gas contained, as (a) 3 kg or more : at least once every 12 months – except for hermetically sealed systems containing less than 6 kg;

(b) 30 kg or more : at least once every 6 months (12 months with an appropriate leakage detection system);(c) 300 kg or more : at least once every 3 months (6 months with an appropriate leakage detection system – which is anyway mandatory).

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Attachment B.6 – Relevant Planning Authority A copy of the EIS and Appropriate Assessment documents submitted as part of the planning permission for the Biologics II facility (Planning Reference P12/451) have also been submitted along with this application. Summary of Previous Planning Permission A summary of all previous planning permission granted to Allergan Pharmaceuticals Ireland is outlined below. • 1998 – Erection of a single storey temporary office building to the rear of the existing facility

(Ref: P98/1888). • 1999 – Erection of a packaging hall extension to the east of the existing facility together

with other miscellaneous works inclusive of office expansion to the north of the existing building (Ref; P44/6).

• 2000 – Construct new entrance for vehicular traffic at Allergan Botox (Ref: P00/13). • 2000 – Two storey office extension and associated ground works (Ref: P00/30). • 2002 – Extension of existing manufacturing facility to incorporate additional manufacturing

area, packaging hall, laboratories, offices, mezzanine plant room, services compound, employees facilities, together with associated car parking, site fill and landscaping works (Ref: P02/29).

• 2005 – Development of single storey security office and meeting room building (Ref: P

04/87). • 2007 – Permission for single storey laboratory write up extension to front of existing

laboratory building including modifications and landscaping to existing car park area adjoining Carrowbeg Road (Ref: P07/49).

• 2012 – Material change of use to part of the existing warehouse to form a production

facility. (Ref: P12/20) • 2012 – Construction of a new production facility with an overall floor area of 15,677m2

consisting of the three storey office block with a floor area of 3,456m2 and a height of 16m, a production hall and plant rooms with a floor area of 8,705m2 and a height of 12.7m, a warehouse and ancillary accommodation of 3,216m2 and height of 15.8m incorporating six loading bays with HGV access and an external storage building of 115m2 and height of 6.3m. Site works will include the relocation of an existing local access road and the construction of a new circulation route to the existing Allergan facility, together with the provision of 223 no. car parking spaces in two phases and a service and utility yard of 985m2, new pedestrian and cycle links to the existing facility, new pedestrian link bridge of 140m2 and a height of 8.8m to the existing multi agency enterprise building and all associated site works and boundary treatments. (Ref: P12/451)

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Licenses and Permits Past and Present Table B.6.A Table of reference for all licences and permits past and present

Licence/Permit Type Reference Number Date Granted Currently

Applicable

Licence

Integrated Pollution Prevention Control

P0126-01 27/03/1997 No

Licence


P0126-02 04/06/2008 Yes

Licence


P0126-02 Technical Amendment A

07/10/2010 Yes

Licence


P0126-02 Technical Amendment B

05/10/2012 Yes

Permit Greenhouse Gas Emissions Permit

IE-GHG153-10422 01/03/2013 Yes

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Headquarters, Johnstown Castle Estate,County Wexford, Ireland

GREENHOUSE GAS EMISSIONS PERMIT

Permit Register Number: IE-GHG153-10422

Operator: Allergan Pharmaceuticals IrelandCastlebar RoadCarrowbegWestportMayo

Installation Name:

Site Name:



Location: Castlebar RoadWestportMayoIreland

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Environmental Protection Agency GHG Permit No. IE-GHG153-10422

Explanatory Note

Introductory NoteThis introductory note does not form a part of the Greenhouse Gas Emissions Permit.

This Greenhouse Gas Emissions Permit authorises the holder to undertake named activities resulting in

emissions of Carbon Dioxide from the listed emission sources. It also contains requirements that must be met

in respect of such emissions, including monitoring and reporting requirements. This Greenhouse Gas Emissions

Permit places an obligation on the Operator to surrender allowances to the Agency equal to the annual

reportable emissions of carbon dioxide equivalent from the installation in each calendar year, no later than

four months after the end of each such year.

Contact with Agency:

If you contact the Agency about this Greenhouse Gas Emissions Permit please quote the following reference:

Greenhouse Gas Emissions Permit No IE-GHG153-10422.

All correspondence in relation to this permit should be addressed to:

Email: [email protected]

By Post: Climate Change Unit, Environmental Protection AgencyRegional Inspectorate, McCumiskey House,Richview, Clonskeagh Road, Dublin 14

Updating of the permit:

This Greenhouse Gas Emissions Permit may be updated by the Agency, subject to compliance with Condition 2.

The current Greenhouse Gas Emissions Permit will normally be available on the Agency’s website at

www.epa.ie and ETSWAP.

Surrender of the permit:

Before this Greenhouse Gas Emissions Permit can be wholly or partially surrendered, a written application

must be made to the on-line ETS portal, and written permission received from, the Agency through ETSWAP.

Transfer of the permit or part of the permit:

Before this Greenhouse Gas Emissions Permit can be wholly or partially transferred to another Operator a joint

written application to transfer this Greenhouse Gas Emissions Permit must be made (by both the existing and

proposed Operators) to, and written permission received from, the Agency through the on-line ETS portal

ETSWAP.

Licence held pursuant to Directive 1996/61/EC (as of the date of this permit):

IPC/IPPC Licence Register Number

P0126-02

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http://www.epa.ie

https://ets.epa.ie/Authentication/Logon.aspx?ReturnUrl=%2fDefault.aspx




Status Log

Status Log

Permit

Permit number Date application received Date further information received

Date Permit issued

IE-GHG153-10422 19 February 2013 01 March 2013

Changes to Permit

Notice number

Change Type Date application received

Date further information received

Date Notice issued

Comment

N/A N/A N/A N/A N/A N/A

End of Introductory Note

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Page 2

Glossary of TermsFor the purposes of this permit the terms listed in the left hand column shall have the meaning given in the right hand column below:

The Agency Environmental Protection Agency.

Agreement Agreement in writing.

Allowance Permission to emit to the atmosphere one tonne of carbon dioxide equivalent during a specified period issued for the purposes of Directive 2003/87/EC by the Agency or by a designated national competent authority of a Member State of the European Union.

Annual Reportable Emissions

Reportable Emissions of carbon dioxide made in any calendar year commencing from 1 January 2005 or the year of commencement of the activity, whichever is the later.

A & V Regulation Commission Regulation (EU) No 600/2012 of 21 June 2012 on the verification of greenhouse gas emission reports and tonne-kilometre reports and the accreditation of verifiers pursuant to Directive 2003/87/EC of the European Parliament and of the Council and any amendments or revisions thereto.

Category A Installation

As defined in Article 19.2 (a) of the M&R Regulation.

Category B Installation

As defined in Article 19.2 (b) of the M&R Regulation.

Category C Installation

As defined in Article 19.2 (c ) of the M&R Regulation.

The Directive Directive 2003/87/EC of the European Parliament and of the Council of 13

October 2003 establishing a scheme for greenhouse gas emission allowance trading within the Community and amending Council Directive 96/61/EC.

Emissions The release of greenhouse gases into the atmosphere from sources in an installation.

EPA Environmental Protection Agency.

Fall-Back Methodology

As defined in Article 22 of the M&R Regulation.

GHG Greenhouse gas.

GHG Permit Greenhouse gas emissions permit.

Greenhouse Gas Any of the gases in Schedule 2 of the Regulations.

IPC/IPPC Integrated Pollution Control/Integrated Pollution Prevention and Control.

Installation Any stationary technical unit where one or more activities listed in Schedule 1 to the Regulations are carried out. Also any other directly associated activities which have a technical connection with the activities carried out on that site and which could have an effect on emissions and pollution. References to an installation include references to part of an installation.

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Page 3

Installation with low emissions

As defined in Article 47 of the M&R Regulation.

Major Source Streams

As defined in Article 19.3 (c ) of the M&R Regulation.

M&R Regulation Commission Regulation (EU) No 601/2012 of 21 June 2012 on the monitoring and reporting of greenhouse gas emissions pursuant to Directive 2003/87/EC of the European Parliament and of the Council and any amendments or revisions thereto.

Mis-statement An omission, misrepresentation or error in the Operators reported data, not considering the uncertainty permissible pursuant to Article 12(1)(a) of Regulation (EU) no 601/2012.

N/A Not applicable.

Monitoring Plan The Plan submitted and approved in accordance with Condition 3.1 of this permit and attached at Appendix 1.

Non-conformity Any act or omission by the Operator, either intentional or unintentional, that is contrary to the greenhouse gas emissions permit and the requirements of the Monitoring Plan.

The National Administrator

The person so designated in accordance with the requirements of any Regulations adopted as provided for under Article 19.3 of Directive 2003/87/EC.

The Operator (for the purposes of this permit)


“operator” Any person who operates or controls an installation or to whom decisive economic power over the functioning of the installation has been delegated.

Person Any natural or legal person.

Reportable emissions

The total releases to the atmosphere of carbon dioxide (expressed in tonnes of carbon dioxide equivalent) from the emission sources specified in Table 2 and arising from the Schedule 1 activities which are specified in Table 1.

The Regulations European Communities (Greenhouse Gas Emissions Trading) Regulations 2012 (S.I. No 490 of 2012) and any amendments or revisions thereto.

The Verifier A legal person or another legal entity carrying out verification activities pursuant to Regulation (EU) No 600/2012 and accredited by a national accreditation body pursuant to Regulation (EC) No 765/2008 and Regulation (EU) No 600/2012 or a natural person otherwise authorised, without prejudice to Article 5(2) of Regulation (EC) No 765/2008, at the time a verification report is issued.

The Registry The Registry as provided for under Article 19 of Directive 2003/87/EC.

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Page 4

Schedule 1 Schedule 1 to the Regulations.

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Page 5

Reasons for the DecisionThe Agency is satisfied, on the basis of the information available, that subject to compliance with the conditions of this permit, the Operator is capable of monitoring and reporting emissions in accordance with the requirements of the Regulations.

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Activities Permitted

Pursuant to the Regulations the Agency issues this Greenhouse Gas Emissions Permit, subject to any subsequent revisions, corrections or modifications it deems appropriate, to:

The Operator:

Allergan Pharmaceuticals IrelandCastlebar RoadCarrowbegWestportMayo

Company Registration Number: 514125

to carry out the following

Categories of activity:

Annex 1 ActivityCombustion of fuels in installations with a total rated thermal input exceeding 20 MW (except in installations for the incineration of hazardous or municipal waste)

at the following installation(s):

Allergan Pharmaceuticals Ireland Installation number: 113

located at

Castlebar RoadWestportMayoIreland

subject to the five conditions contained herein, with the reasons therefor and associated tables attached thereto.

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Page 6

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Page 7

Conditions

Condition 1. The Permitted Installation

1.1 This permit is being granted in substitution for the GHG permit granted to the Operator on 29 June 2011 and bearing Permit Register No.: IE-GHG153-03. The previous GHG permit (Permit Reg. No. IE-GHG153-03) is superseded by this permit from 1 January 2013.

1.2 The Operator is authorised to undertake the activities and/or the directly associated activities specified in Table 1 below resulting in the emission of carbon dioxide:

Table 1 - Activities which are listed in Schedule 1 of the Regulations and other directly associated activities carried out on the site:

Installation No.: 113

Activity DescriptionCombustion of fuels in installations with a total rated thermal input exceeding 20 MW (except in installations for the incineration of hazardous or municipal waste)

Directly Associated Activity DescriptionN/A

1.3 Carbon dioxide from Schedule 1 activities shall be emitted to atmosphere only from the emission sources as listed in Table 2 below:

Table 2 Emission Sources and Capacities:

Emission Source Reference Emission Source Description Capacity Capacity Units

S1 BG001 - Botox Emergency Generator #1 - P550E 1.26 MW

S2 BG002 - Botox Emergency Generator #2 - P880E 2.09 MW

S3 PG003 - Pharma Emergency Generator#3 PRR665 4.91 MW

S4 BG004 - Botox Emergency Generator #4 - FGW P2220E 5.26 MW

S5 BH001 - Boiler #1 - BIB Cochran 3.82 MW



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Page 8

Emission Source Reference Emission Source Description Capacity Capacity Units

S8 Kitchen - Various 0.5 MW

S9 FE001 - Fire Pump Engine - Cummins 0.5 MW

S11 FE002 - Fire Pump Engine - Cummins 0.5 MW

S12 SS001 - Boiler #1 - Rendamax R4303 0.85 MW

S13 SS002 - Boiler #2 - Rendamax R4303 - 0.85 MW

S14 SS003 - Emergency Generator - CAT GEP165 0.17 MW

S15 SS004 LPG Burner 0.5 MW

1.4 The activity shall be controlled, operated and maintained so that emissions of carbon dioxide shall take place only as set out in this GHG Emissions Permit. The permit does not control emissions of gases other than carbon dioxide. All agreed plans, programmes and methodologies required to be carried out under the terms of this permit, become part of this permit.

1.5 This GHG Permit is for the purposes of GHG emissions permitting under the European Communities (Greenhouse Gas Emissions Trading) Regulations 2012 and any amendments to the same only and nothing in this permit shall be construed as negating the Operator’s statutory obligations or requirements under any other enactments or regulations unless specifically amended by the Regulations.

1.6 Any reference in this permit to ‘installation’ shall mean the installation as described in the Greenhouse Gas Emissions Permit application and any amendments approved by the Agency.

Reason: To describe the installation and clarify the scope of this permit.

Condition 2. Notification

2.1 No alteration to, or reconstruction in respect of, the activity or any part thereof which would, or is likely to, result in a change in:

2.1.1 the nature or functioning of the installation;

2.1.2 the capacity of the installation as detailed in this permit;

2.1.3 the fuels used at the installation;

2.1.4 the range of activities to be carried out at the installation

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that may require updating of the GHG permit shall be carried out or commenced without prior notice to and without the prior written agreement of the Agency.

2.2 The Operator shall notify the Agency in writing of the cessation of all or part of any activity listed in Table 1 of this permit no later than one month from the date of cessation or by 31 December of the year of cessation, whichever is sooner.

2.3 The Operator shall apply for an update of this GHG Permit where there is a change to the Operator name and/or registered address of the Operator, within seven days of the change.

2.4 For installations or parts of installations which have not come into operation when the application for this permit was made the Operator shall notify the Agency of the date of commencement of the activity within seven days of commencement.

2.5 The Operator shall notify the Agency in writing within three days of becoming aware of any factors which may prevent compliance with the conditions of this permit.

2.6 The Operator shall submit to the Agency by 21 January of each year a declaration of operability. The declaration submitted shall be in the format required by the Agency.

2.7 All notifications required under Condition 2 above shall be made to the address given in the Explanatory Note included with this permit.

2.8 The Operator shall submit to the Agency by 31 December of each year all relevant information about any planned or effective changes to the capacity, activity level and operation of an installation. The information submitted shall be in the format required by the Agency.

Reason: To provide for the notification of updated information on the activity.

Condition 3. Monitoring and Reporting

3.1 The Operator shall monitor and record greenhouse gas emissions on site in accordance with the M&R Regulation and the approved Monitoring Plan attached at Appendix 1 to this GHG permit and in compliance with any other guidance approved by the Agency for the purposes of implementing the Directive and/or the Regulations.

3.2 The Operator shall modify the monitoring plan in any of the following situations:

3.2.1 new emissions occur due to new activities carried out or due to the use of new fuels or materials not yet contained in the monitoring plan;

3.2.2 the change of availability of data, due to the use of new measurement instrument types, sampling methods or analysis methods, or for other reasons, leads to higher accuracy in the determination of emissions;

3.2.3 data resulting from the previously applied monitoring methodology has been found incorrect;

3.2.4 changing the monitoring plan improves the accuracy of the reported data, unless this is technically not feasible or incurs unreasonable costs;

3.2.5 the monitoring plan is not in conformity with the requirements of the M&R Regulation and the Agency requests a change;

3.2.6 it is necessary to respond to the suggestions for improvement of the monitoring plan contained in the verification report.

The Operator shall notify any proposals for modification of the monitoring plan to the Agency without undue delay. Any significant modifications of the monitoring plan, as defined in Article 15

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of the M&R Regulation, shall be subject to approval by the Agency. Where approved these changes shall be implemented within a timeframe agreed by the Agency.

3.3 Temporary changes to the monitoring methodology:

3.3.1 Where it is for technical reasons temporarily not feasible to apply the tier in the monitoring plan for the activity data or each calculation factor of a fuel or material stream as approved by the Agency, the Operator shall apply the highest achievable tier until the conditions for application of the tier approved in the monitoring plan have been restored. The Operator shall take all necessary measures to allow the prompt restoration of the tier in the approved monitoring plan. The Operator shall notify the temporary change to the monitoring methodology without undue delay to the Agency specifying:

(i) The reasons for the deviation from the tier;

(ii) in detail, the interim monitoring methodology applied by the Operator to determine the emissions until the conditions for the application of the tier in the monitoring plan have been restored;

(iii) the measures the Operator is taking to restore the conditions for the application of the tier in the approved monitoring plan;

(iv) the anticipated point in time when application of the approved tier will be resumed.

3.3.2 A record of all non-compliances with the approved monitoring plan shall be maintained on-site and shall be available on-site for inspection by authorised persons of the Agency and/or by the Verifier at all reasonable times.

3.4 The Operator shall appoint a Verifier to ensure that, before their submission, the reports required by Condition 3.5 below are verified in accordance with the criteria set out in Schedule 5 of the Regulations, the A&V Regulation and any more detailed requirements of the Agency.

3.5 The written report of the verified annual reportable emissions and the verification report in respect of each calendar year shall be submitted to the Agency by the Operator no later than 31 March of the following year. The reports shall be in the format required by the Agency and meet the criteria set out in the M&R and A&V Regulations.

3.6 The Operator shall enter the verified annual reportable emissions figure for the preceding year into the Registry no later than 31 March of the following year. This figure shall be electronically approved by the Verifier in the registry no later than 31 March of each year.

3.7 Where an Operator is applying the Fall-Back methodology, the Operator shall assess and quantify each year the uncertainties of all parameters used for the determination of the annual emissions in accordance with the ISO Guide to the Expression of Uncertainty in Measurement or another equivalent internationally accepted standard and include the verified results in the written report of the verified annual reportable emissions to be submitted to the Agency by 31 March each year.

3.8 An Operator shall submit to the Agency for approval a report containing the information detailed in (i) or (ii) below, where appropriate, by the following deadlines:

(a) for a category A installation, by 30 June every four years;

(b) for a category B installation, by 30 June every two years;

(c) for a category C installation, by 30 June every year.

(i) Where the Operator does not apply at least the tiers required pursuant to the first subparagraph of Article 26(1) and to Article 41(1) of the M&R Regulation, the Operator shall provide a justification as to why it is technically not feasible or would incur unreasonable costs to apply the required tiers. Where evidence is found that measures needed for

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reaching those tiers have become technically feasible and do not incur unreasonable costs, the Operator shall notify the Agency of appropriate modifications to the monitoring plan and submit proposals for implementing appropriate measures and its timing.

(ii) Where the Operator applies a fall-back monitoring methodology, the Operator shall provide a justification as to why it is technically not feasible or would incur unreasonable costs to apply at least tier 1 for one or more major or minor source streams. Where evidence is found that measures needed for reaching at least tier 1 for those source streams have become technically feasible and do not incur unreasonable costs, the Operator shall notify the Agency of appropriate modifications to the monitoring plan, submit proposals and a timeframe for implementing appropriate measures.

3.9 Where the verification report states outstanding non conformities, misstatements or recommendations for improvements the Operator, except the Operator of an installation with low emissions, shall submit a report to the Agency for approval by 30 June of the year in which the verification report is issued. That report shall describe how and when the Operator has rectified or plans to rectify the non-conformities identified and to implement recommended improvements. Where recommended improvements would not lead to an improvement of the monitoring methodology this must be justified by the Operator. Where the recommended improvements would incur unreasonable costs the Operator shall provide evidence of the unreasonable nature of the costs. The Operator shall implement the improvements specified by the Agency in response to the report submitted in accordance with this Condition in accordance with a timeframe set by the Agency.

3.10 The Operator shall make available to the Verifier and to the Agency any information and data relating to emissions of carbon dioxide which are required in order to verify the reports referred to in Condition 3.5 above or as required by the Agency to facilitate it in establishing benchmarks and/or best practice guidance.

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

3.12 The Operator shall retain all information as specified in the M&R Regulation for a period of at least 10 years after the submission of the relevant annual report.

3.13 A record of independent confirmation of capacities listed in this permit or agreed with the Agency in writing as minor emissions shall be available on-site for inspection by authorised persons of the Agency at all reasonable times.

3.14 The Operator shall keep records of all modifications of the monitoring plan. The records shall include the information specified in Article 16.3 of the M&R Regulation.

3.15 The Operator shall ensure that members of the public can view a copy of this permit and any reports submitted to the Agency in accordance with this permit at all reasonable times. This requirement shall be integrated with the requirements of any public information programme approved by the Agency in relation to any other permit or licence held by the Operator for the site.

Reason: To provide for monitoring and reporting in accordance with the Regulations.

Condition 4. Allowances

4.1 Surrender of Allowances

4.1.1 The Operator shall, by 30 April in each year, surrender to the Agency, or other appropriate body specified by the Agency, allowances equal to the annual reportable emissions in the preceding calendar year.

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4.1.2 The number of allowances to be surrendered shall be the annual reportable emissions for the preceding calendar year plus such allowances as may be necessary to cover any earlier calendar year in respect of which allowances remain outstanding and due. This includes allowances to cover the amount of any annual reportable emissions in respect of which allowances were not surrendered in accordance with Condition 4.1.1 in the previous year, and the amount of any reportable emissions which were discovered during the previous year to have been unreported in reports submitted under Condition 3 in that or in earlier years.

4.1.3 In relation to activities or parts of activities which have ceased to take place and have been notified to the Agency in accordance with Condition 2.2 above, the Operator shall surrender to the Agency allowances equal to the annual reportable emissions from such activities in the preceding calendar year or part thereof, together with such allowances as may be necessary to cover any earlier calendar year in respect of which allowances remain outstanding and due as described in Condition 4.1.2 above.

4.1.4 The Operator may, from 2008 onwards, subject to the provisions of the Regulations and the relevant National Allocation Plan for that compliance year, surrender emission reduction units (ERUs) and certified emission reduction units (CERs) in place of allowances.

4.2 The holding, transfer, surrender and cancellation of allowances shall be in accordance with the requirements of any Regulations adopted as provided for under Article 19.3 of Directive 2003/87/EC, any amendment or revision to the same and any guidance issued by the Agency or the National Administrator.

4.3 The Operator shall provide the National Administrator with all the necessary information for the opening of an Operator holding account for the installation described in Condition 1 of this permit within twenty working days of the issue of this permit, unless such an account is already open.

Reason: To provide for the surrendering, holding, transfer and cancellation of allowances in respect of reported emissions.

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Condition 5. Penalties

5.1 Any Operator who fails to comply with Condition 4.1 above shall be subject to the provisions of the Regulations, including, but not limited to the payment of penalties.

Reason: To provide for the payment of excess emissions penalties as required under the Regulations.

Sealed by the seal of the Agency on this the 01 March 2013:

PRESENT when the seal of the Agency was affixed hereto:

__________________________Mr. Marc KieransInspector/ Authorised Person

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Appendix 1 to Greenhouse Gas Emissions Permit Number IE-GHG153-10422

Monitoring Plan

1. Guidelines & Conditions

1. Directive 2003/87/EC as amended by Directive 2009/29/EC (hereinafter "the (revised) EU ETS Directive") requires operators of installations which are included in the European Greenhouse Gas Emission Trading Scheme (the EU ETS) to hold a valid GHG emission permit issued by the relevant Competent Authority and to monitor and report their emissions and have the reports verified by an independent and accredited verifier.

The Directive can be downloaded from:

http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CONSLEG:2003L0087:20090625:EN:PDF

2. The Monitoring and Reporting Regulation (Commission Regulation (EU) No 601/2012) (hereinafter the "MRR") defines further requirements for monitoring and reporting.

The MRR can be downloaded from:

http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2012:181:0030:0104:EN:PDF

Article 12 of the MRR sets out specific requirements for the content and submission of the monitoring plan and its updates. Article 12 outlines the importance of the Monitoring plan as follows:

The monitoring plan shall consist of a detailed complete and transparent documentation of the monitoring methodology of a specific installation [or aircraft operator] and shall contain at least the elements laid down in Annex I.

Furthermore Article 74(1) states:

Member States may require the operator and aircraft operator to use electronic templates or specific file formats for submission of monitoring plans and changes to the monitoring plan as well as for submission of annual emissions reports tonne-kilometre data reports verification reports and improvement reports. Those templates or file format specifications established by the Member States shall at least contain the information contained in electronic templates or file format specifications published by the Commission

3. All Commission guidance documents on the Monitoring and Reporting Regulation will be published at the link below as they become available:

http://ec.europa.eu/clima/policies/ets/monitoring/index_en.htm

(a) Information sources:

EU Websites:

EU-Legislation: http://eur-lex.europa.eu/en/index.htmEU ETS general: http://ec.europa.eu/clima/policies/ets/index_en.htm

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http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2012:181:0030:0104:EN:PDF


http://eur-lex.europa.eu/en/index.htm

http://ec.europa.eu/clima/policies/ets/index_en.htm


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Monitoring and Reporting in the EU ETS: http://ec.europa.eu/clima/policies/ets/monitoring/index_en.htm

Environmental Protection Agency Website:

http://www.epa.ie

Environmental Protection Agency Contact:

[email protected]

2. Application Details

The Installation Name, Site Name and the address of the site of the installation are detailed below. The Site Name and address can be updated from the Organisation Details Page on the ETSWAP website. The Installation Name can only be updated by your Competent Authority.

Installation name Allergan Pharmaceuticals Ireland

Site name Allergan Pharmaceuticals Ireland

Address Castlebar RoadWestportMayoIreland

Grid reference of site main entrance 100532, 284990

Licence (or licenses) held pursuant to Directive 1996/61/EC IPPC/IPC (at the date of this application)

Yes

IPC/IPPC Licence Register Number Licence holder Competent body

P0126-02 Allergan Pharamceuticals Ireland Environmental Protection AgencyHas the regulated activity commenced at the Installation? YesDate of Regulated Activity commencement 01 January 2008

This information is only required to identify the first relevant reporting year of an installation. If the installation was in operation from the beginning of 2008 and held a Greenhouse Gas Emissions Permit from this point, 1 January 2008 will be used where the actual date of commencement is not readily known.

3. About the Operator

The information about the "Operator" is listed below. The "Operator" is defined as the person who it is proposed will have control over the relevant Regulated Activities in the installation in respect of which this application is being made.

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(b) Operator Details

The name of the operator and where applicable the company registration number are detailed below. These details can only be updated by the Environmental Protection Agency.

Operator name Allergan Pharmaceuticals Ireland

Company Registration Number 514125

Operator Legal status

The legal status of the operator is: Company / Corporate Body

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(c) Company / Corporate Body

Is the trading / business name different to the operator name?

No

Details of the individual authorised to submit this application on behalf of the company / corporate body.

Title MrForename TomSurname QuinnPosition Director, Technicial Services

Registered office address

Address Line 1 Castlebar RoadAddress Line 2 CarrowbegCity/Town WestportCounty MayoPostcode N/A

Principal office address

Is the principal office address different to the registered office address?

No

Holding company

Does the company belong to a holding company? No

(d) Operator Authority

Does the operator named above have the authority and ability to:

a. manage site operations through having day-to-day control of plant operation including the manner and rate of operation

Yes

b. ensure that permit conditions are effectively complied with

Yes

c. control monitor and report specified emissions Yes

d. be responsible for trading in Allowances so that at the Yes

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end of a reporting period allowances can be balanced against reported emissions.

4. Service Contact

e. Service Contact

Name Ms Elaine Rowley

Address / Email Address Castlebar RoadCarrowbegWestportMayoIreland

5. Installation Activities

f. Installation Description

Below is a description of the installation and its activities, a brief outline description of the site and the installation and the location of the installation on the site. The description also includes a non-technical summary of the activities carried out at the installation briefly describing each activity performed and the technical units used within each activity.

Allergan Pharmaceuticals Ireland is a manufacturer of medicinal products. The activities at the site comprised of aseptic manufacture (formulation) of all classes of Ophthalmic preparations, including Prescription drugs, optic muscle relaxants and ophthalmic surgery solutions. The facility is located in Westport, Co. Mayo. The installations at the site include 3 primary natural gas fired boilers, 4 diesel oil fired generators A site map illustrating the location of the main installations is currently being drafted to include new emission points.

The installations on the site have an aggregate combustion capacity exceeding 20MW thermal input, which constitutes the regulated activity operated by Allergan Pharmaceuticals Ireland.

- The main Boiler Plant consists of 3 x 3.82 MW thermal input gas fired boilers.

- There are also 4 diesel oil fired generators totalling over 10 MW thermal input capacity.

- In addition, it is planned to operate 2 x boilers (865kW each) and 1 small diesel oil fired generator (<0.5MW) in 2013 and thus they have been included in this application.

The fuels used at the site are natural gas, LPG and Diesel/Gas Oil. The combustion of these 3 fuels is the only process operated by Allergan on the site that gives rise to the production of carbon dioxide.

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g. Annex 1 Activities

The table below lists the technical details for each Annex 1 activity carried out at the installation.

Note that 'capacity' in this context means:

Rated thermal input (for combustion installations) which is defined as the rate at which fuel can be burned at the maximum continuous rating of the installation multiplied by the calorific value of the fuel and expressed as megawatts thermal.

Production capacity for those specified Annex I activities for which production capacity determines ETS eligibility.

Annex 1 Activity Total Capacity Capacity units Specified Emissions

Combustion of fuels in installations with a total rated thermal input exceeding 20 MW (except in installations for the incineration of hazardous or municipal waste)

28.85 MW Carbon Dioxide

h. Site Diagram

The table below lists attachments (if available) that provide a simple diagram showing emissions sources source streams sampling points and metering/measurement equipment.

Attachment Description

2013_Emission_Point_Map.pdf Site plan for Phase III (2013-2020)

i. Estimated Annual Emissions

Detail of the estimated annual emission of CO2 equivalent. This information enables categorisation of the installation in accordance with Article 19 of the MRR and is based on the average verified annual emissions of the previous trading period data OR if this data is not available or is inappropriate a conservative estimate of annual average emissions including transferred CO2 excluding CO2 from biomass.

Estimated Annual Emissions (tonnes CO2(e)) 6200

Installation Category: A

6. Emissions Details

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j. About your emissions

Annex I of the Monitoring and Reporting Regulations (MRR) requires that monitoring plans include a description of "the installation" and activities to be carried out and monitored including a list of emission sources and source streams. The information provided in this template relates to the Annex I activity(ies) comprised in the installation in question and should relate to a single installation. It includes any activities carried out by the operator and does not include related activities carried out by other operators.

k. Emission Sources

The table below lists all the emission sources at the installation, which may include directly associated activities/excluded activities.

Emission Source Reference Emission Source Description

S1 BG001 - Botox Emergency Generator #1 - P550E


S3 PG003 - Pharma Emergency Generator#3 PRR665

S4 BG004 - Botox Emergency Generator #4 - FGW P2220E

S5 BH001 - Boiler #1 - BIB Cochran



S8 Kitchen - Various

S9 FE001 - Fire Pump Engine - Cummins


S12 SS001 - Boiler #1 - Rendamax R4303

S13 SS002 - Boiler #2 - Rendamax R4303 -

S14 SS003 - Emergency Generator - CAT GEP165

S15 SS004 LPG Burner

The table below lists the emission sources which are linked to the Regulated Activities at the installation.




S3 PG003 - Pharma Emergency Generator#3 PRR665

S4 BG004 - Botox Emergency Generator #4 - FGW P2220E




S8 Kitchen - Various


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S12 SS001 - Boiler #1 - Rendamax R4303

S13 SS002 - Boiler #2 - Rendamax R4303 -

S14 SS003 - Emergency Generator - CAT GEP165

S15 SS004 LPG Burner

l. Emission Points

The table below lists all the emission points at the installation, which may include directly associated activities/excluded activities.

Emission Point Reference Emission Point Description

A1-1 Botox Generator #1 Exhaust


A1-3 Pharma Generator #3 Exhaust


A2-1 Boiler #1 Stack

A2-2 Boiler #2 Stack

A2-3 Boiler #3 stack

A3-1 Kitchen Area - Various

A3-2 Fire Pump Engine #1 Exhaust



A2-4 SS Boiler #1 Stack

A2-5 SS Boiler #2 Stack

A1-5 SS Generator #5 Exhaust

A3-5 SS LPG Burner

m. Source Streams (fuels and/or materials)

The table below lists the source streams which are used in Schedule 1 Activities at the installation.

Source Stream Reference Source Stream Type Source Stream Description

DGO-001 Combustion: Commercial standard fuels

Gas/Diesel Oil

NG-001 Combustion: Other gaseous & liquid fuels

Natural Gas

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Source Stream Reference Source Stream Type Source Stream Description

LPG-001 Combustion: Other gaseous & liquid fuels

Liquefied Petroleum Gases

NG-002 Combustion: Other gaseous & liquid fuels

Natural Gas

n. Emissions Summary

The table below provides a summary of the emission source and source stream details in the installation.

Source streams ( Fuel / Material )

Emission Source Refs. Emission Point Refs. Annex 1 Activity

DGO-001 S1,S11,S14,S2,S3,S4,S5,S6,S7,S9

A1-1,A1-2,A1-3,A1-4,A2-1,A2-2,A2-3,A3-2,A3-3,A3-4,A1-5

Combustion of fuels in installations with a total rated thermal input exceeding 20 MW (except in installations for the incineration of hazardous or municipal waste)

NG-001 S5,S6,S7 A2-1,A2-2,A2-3 Combustion of fuels in installations with a total rated thermal input exceeding 20 MW (except in installations for the incineration of hazardous or municipal waste)

NG-002 S12,S13 A2-4,A2-5 Combustion of fuels in installations with a total rated thermal input exceeding 20 MW (except in installations for the incineration of hazardous or municipal waste)

LPG-001 S15,S8 A3-1,A3-5 Combustion of fuels in installations with a total rated thermal input exceeding 20 MW (except in installations for the incineration of hazardous or municipal waste)

o. Excluded Activities

Certain activities that result in greenhouse gas emissions may be excluded under the EU ETS Directive for example truly mobile sources such as vehicle emissions.

Do you have any excluded activities which need to be No

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identified in your monitoring plan?

7. Low Emissions Eligibility

p. Low Emissions Eligibility

The operator may submit a simplified monitoring plan for an installation where no nitrous oxide activities are carried out and it can be demonstrated that:

(a) the average verified annual emissions of the installation during the previous trading period was less than 25 000 tonnes CO2(e) per year or;

(b) where this data is not available or inappropriate a conservative estimate shows that emissions for the next 5 years will be less than 25 000 tonnes CO2(e) per year.

Note: the above data shall include transferred CO2 but exclude CO2 stemming from biomass.

Does the installation satisfy the criteria for installations with low emissions (as defined by Article 47 of the MRR)?

Yes

If the installation is an installation with low emissions as defined above there are a number of special provisions which may be applied to provide a simplified monitoring plan. These provisions are set out in Article 47 of the MRR.

8. Monitoring Approaches

q. Monitoring Approaches

Emissions may be determined using either a calculation based methodology ("calculation") or measurement based methodology ("measurement") except where the use of a specific methodology is mandatory according to the provisions of the MRR. [MRR Article 21].

Note: the operator may subject to competent authority approval combine measurement and calculation for different sources. The operator is required to ensure and demonstrate that neither gaps nor double counting of reportable emissions occurs.

Please specify whether or not you propose to apply the following monitoring approaches. Select all monitoring approaches that are applicable to you. The consecutive sections will become mandatory based on the selected approaches.

Calculation YesMeasurement NoFall-back approach NoMonitoring of N2O NoMonitoring of PFC NoMonitoring of transferred / inherent CO2 No

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9. Calculation

r. Approach Description

The calculation approach including formulae used to determine annual CO2 emissions:

The Allergan site comprises of scheduled activities fed by installed natural gas supply meter (GM01 & GM02) and a number of diesel tanks around the site.

Natural gas consumption is reported to Allergan via monthly gas bills. Meter GM01 (and GM02) is read on a daily basis and is converted to m3 at normal temperature and pressure. Data from the nearest gas chromatograph located in Ballygarran is used to derive daily calorific values. This chromatograph is calibrated against reference calibration gas on a daily basis. The emission factor and oxidation factor is taken from the latest country specific emissions as made available on the EPA website -Country Specific Net Calorific Values and CO2 Emission Factors for use in the Annual Installation Emissions Report.

The Energia gas bills show kWh based on gross calorific value. The gross calorific value is converted to net calorific value by multiplying by conversion factor published each year by the EPA (~0.98) and then convert to TJ by multiplying by 3.6 x 10-6. This value is the Activity value figure. The figures are adjusted to standardised gas volume (Nm3) if required.

The CO2 emissions are calculated on an annual basis as the product of the Activity x Net Calorific Value x Emission Factor x Oxidation Factor. The uncertainty assessment associated with the natural gas meters is based on meter accuracy data received from Bord Gais on the turbine gas meters on site.

Diesel oil consumption is calculated by reference to invoiced quantities delivered to the site to estimate the total annual usage of this material. As consumption is low, a 'de minimis approach' has been adopted. The tier 1 oxidation factor is applied for diesel oil. The net calorific value and emission factors data is taken from the latest national inventory figures published by the EPA.

The CO2 emission is calculated on an annual basis as the product of Activity x Net Calorific Value x Emission Factor x Oxidation factor. The uncertainty assessment associated with the metering of diesel oil is based on calibration data received from Allergan oil supplier on tanker flow meters.

LPG consumption is calculated by reference to invoiced quantities. As consumption is very low, a 'de minimis' approach has been adopted.

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s. Measurement Devices

Below is a description of the specification and location of the measurement systems used for each source stream where emissions are determined by calculation

Also a description of all measurement devices including sub-meters and meters used to deduct non-Annex I activities to be used for each source and source stream.

Source Stream Refs.

Emission Source Refs.

Measurement Device Ref.

Type of Measurement Device

Measurement Range

Metering Range Units

Specified Uncertainty (+/- %)

Location

DGO-001 S1,S11,S14,S2,S3,S4,S5,S6,S7,S9

DGO - flow meter s/n 507490

Alpeco Lectrocount meter

n/a n/a n/a Corrib Oil Delivery tanker

NG-001 S5,S6,S7 GM-01 Turbine meter 30-650 m3/h 1.4 Outside Pharma Boiler House

LPG-001 S15,S8 N/A Calor gas truck meter

n/a n/a 1 Calor gas depot - Dublin

NG-002 S12,S13 GM-02 Turbine meter 30-650 m3/h 1.4 Outside SS Production building

Source Stream Refs. Measurement Device Ref.

Determination Method

Instrument Under Control Of

Conditions Of Article 29(1) Satisfied

Invoices Used To Determine Amount Of Fuel Or Material

Trade Partner And Operator Independent

DGO-001 DGO - flow meter s/n 507490

Batch Trade partner Yes Yes Yes

NG-001 GM-01 Continual Trade partner Yes Yes YesLPG-001 N/A Batch Trade partner Yes Yes YesNG-002 GM-02 Continual Trade partner Yes Yes Yes

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t. Applied Tiers

The table below identifies the tiers applied against the relevant input data for each source stream and confirms whether a standard (MRR Article 24) or mass balance (MRR Article 25) approach is applied.

(i) The highest tiers as defined in Annex II of the MRR should be used by Category B and C installations to determine the activity data and each calculation factor (except the oxidation factor and conversion factor) for each major source stream. Category A installations should apply as a minimum the tiers listed in Annex V.

(ii) Operators may apply a tier one level lower than those referred to in sub paragraph (i) above for Category C installations and up to two levels lower for Category A and B installations with a minimum of tier 1 if the operator can demonstrate to the satisfaction of the competent authority that this is not technically feasible or would lead to unreasonable cost to apply the higher tier. The justification for not applying the higher tier should be recorded when completing the tier table.

(iii) The competent authority may allow an operator to apply even lower tiers than those referred to in the sub paragraph (ii) with a minimum of tier 1 for a transition period of up to three years if the operator can demonstrate to the satisfaction of the competent authority that this is not technically feasible or would lead to unreasonable cost to apply the higher tier and provides an improvement plan detailing how and by when at least the tier referred to in sub paragraph (ii) will be achieved. The improvement plan should be referenced in subsequent table and provided to the competent authority at the time of submission of this plan.

(iv) For minor source streams operators shall apply the highest tier which is technically feasible and will not lead to unreasonable costs with a minimum of tier 1 for activity data and each calculation factor. For de-minimis source streams operators may use conservative estimations rather than tiers unless a defined tier can be achieved without additional effort (MRR Article 26(2)).

(v) Installations with low emissions as identified in section 6(d) may apply as a minimum tier 1 for determining activity data and calculation factors for all source streams unless higher accuracy is achievable without additional effort.

* Note 1: For commercial standard fuels the minimum tiers listed in Annex V of the MRR may be applied for all activities in all installations.

* Note 2: If you are intending to apply a fall-back approach please complete the table below and select "n/a" for the tiers to be applied for each source stream where a fall-back approach is used. Section 10 "Fall-back" must also be completed for these source streams.

* Note 3: For biomass or mixed fuels the emission factor is the preliminary emission factor as defined in Definition 35 Article 3 of the MRR.

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Source Stream Refs.


Measurement Device Refs.

Overall Metering Uncertainty (less than +/- %)

Applied Monitoring Approach

Activity Data Tier Applied

Net Calorific Value Tier Applied

Emission Factor Tier Applied

Carbon Content Tier Applied

Oxidation Factor Tier Applied

Conversion Factor Tier Applied

Biomass Fraction Tier Applied

Estimated Emissions tCO2(e)

% of Total Estimated Emissions

Source Category

Highest Tiers Applied

Justification for not applying the highest tiers

Improvement Plan Reference (where applicable)

DGO-001

S1,S11,S14,S2,S3,S4,S5,S6,S7,S9

DGO - flow meter s/n 507490

<7.5% Standard

No tier 2a 2a N/A 1 N/A N/A 107 1.72 De-minimis

Yes n/a n/a

LPG-001

S8,S15 N/A N/A Standard

No tier 2a 2a N/A 1 N/A N/A 6 0.1 De-minimis

Yes n/a n/a

NG-001

S5,S6,S7

GM-01 <1.5% Standard

4 2b 2a N/A 1 N/A N/A 5555 89.27 Major Yes n/a n/a

NG-002

S12,S13

GM-02 <1.5% Standard

4 2b 2a N/A 1 N/A N/A 555 8.92 Minor Yes n/a n/a

Total Estimated Emissions for Calculation (tonnes CO2(e)) 6223

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u. Applied tiers

Applied tiers for each source stream

Source Stream Ref.


Activity Data Tier Applied

Net Calorific Value Tier Applied

Emission Factor Tier Applied

Carbon Content Tier Applied

Oxidation Factor Tier Applied

Conversion Factor Tier Applied

Biomass Fraction Tier Applied

DGO-001 S1,S11,S14,S2,S3,S4,S5,S6,S7,S9

No tier 2a 2a N/A 1 N/A N/A

LPG-001 S8,S15 No tier 2a 2a N/A 1 N/A N/A

NG-001 S5,S6,S7 4 2b 2a N/A 1 N/A N/A

NG-002 S12,S13 4 2b 2a N/A 1 N/A N/A

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v. Justification for Applied tiers

Justifications for the applied tiers for each major source stream where highest tiers are not currently achieved.

Source Stream Ref. Emission Source Refs. Justification for the applied tier

Improvement Plan Reference (where applicable)

N/A N/A N/A N/A

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10. Calculation Factors

w. Default Values

The table below lists, for each parameter, where default values are to be used for calculation factors.

Source Stream Refs. Emission Source Refs. Parameter Reference Source Default Value applied (where appropriate)

DGO-001,LPG-001 S1,S11,S14,S15,S2,S3,S4,S8,S9 NCV Ireland's National Greenhouse Gas Inventory

n/a

DGO-001,NG-001,LPG-001,NG-002

S1,S11,S12,S13,S14,S15,S2,S3,S4,S5,S6,S7,S8,S9

EF & OxF Ireland's National Greenhouse Gas Inventory

n/a

Sampling and Analysis

Do you undertake sampling and analysis of any of the parameters used in the calculation of your CO2 emissions?

No

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11. Management

x. Monitoring and Reporting Responsibilities

Responsibilities for monitoring and reporting emissions from the installation are listed below:

Relevant job titles/posts and provide a succinct summary of their role relevant to monitoring and reporting are listed below.

Job Title / Post Responsibilities

EHS Specialist Completion and submission of Annual Installation Emissions Report and M & R plan. Also ensuring compliance with Greenhouse Gas permit requirements

Director of Technical Services Responsible for maintenance and operation of all combustion installations at the facility and overall management of Greenhouse Gas program at the Allergan Westport facility.

Utilities Manager - Maintaining/ recording of all fuel delivery dockets and gas bills on site.

- Also notifying EHS of any changes in emissions sources.


N/A N/A

y. Assignment of Responsibilities

Details of the procedure used for managing the assignment of responsibilities for monitoring and reporting within the installation and for managing the competencies of responsible personnel in accordance with Article 58(3)(c) of the MRR:

This procedure identifies how the monitoring and reporting responsibilities for the roles identified above are assigned and how training and reviews are undertaken.

Title of procedure Delivery, Monitoring and Reporting of Natural Gas, Diesel, LPG and their Greenhouse Gas emissions

Reference for procedure BEFA27Diagram reference N/ABrief description of procedure. The description should cover the essential parameters and operations performed

Outlines who is responsible for management of monitoring and reporting of greenhouse gas emissions.

EHS Specialist: Completion and submission of Annual Installation Emissions Report and M & R plan. Also ensuring compliance with Greenhouse Gas permit requirements.

Director of Technical Services: Responsible for maintenance and operation of all combustion installations at the facility and overall management of Greenhouse Gas program at

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the Allergan Westport facility.

Utilities Manager: Maintaining/ recording of all fuel delivery dockets and gas bills on site. Also notifying EHS of any changes in emissions sources.

The Nominated Verifier verifies the data.Post or department responsible for the procedure and for any data generated

Environmental, Health and Safety Department

Location where records are kept EHS OfficeName of IT system used CORALList of EN or other standards applied n/a

z. Monitoring Plan Appropriateness

Details of the procedure used for regular evaluation of the monitoring plan's appropriateness covering in particular any potential measures for the improvement of the monitoring methodology:



Outlines requirements for Monitoring and Reporting Plan submission to evaluate the monitoring plan's appropriateness in particular, any potential measures for the improvement of the monitoring methodology.

Post or department responsible for the procedure and for any data generated


Location where records are kept EHS OfficeName of IT system used CORALList of EN or other standards applied N/A

aa. Data Flow Activities

Details of the procedures used to manage data flow activities in accordance with Article 57 of the MRR:



Outlines how the data is collated and calculated. The Data flow activities are shown for each source stream in data flow diagrams which show how the data management procedures link together.



Location where records are kept EHS OfficeName of IT system used CORALList of EN or other standards applied N/AList of primary data sources Fuel bills/delivery dockets for Gas oil and LPG.

Monthly bills for Natural gas.Description of the relevant processing steps for each Natural gas: Monthly meter readings are sent to the

installation by the gas network operator The NCV for

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specific data flow activity.

Identify each step in the data flow and include the formulas and data used to determine emissions from the primary data. Include details of any relevant electronic data processing and storage systems and other inputs (including manual inputs) and confirm how outputs of data flow activities are recorded

natural gas is calculated and recorded using formulas in an Excel spreadsheet.

Gas Oil: The volume of gas oil offloaded from the delivery vehicle is recorded on a delivery docket by the supplier. The supplier sends an invoice for the quantity of gas oil supplied to the installation. The data from the invoices and stock adjustment calculations is used to calculate the total quantity of gas oil used by the installation. The total quantity of gas oil used by the installation is used to calculate and record emissions from this source stream using formulas in an Excel spreadsheet.

LPG: The volume of LPG offloaded from the delivery vehicle is recorded on a delivery docket by the supplier. The supplier sends an invoice for the quantity of LPG supplied to the installation. The data from the invoices and stock adjustment calculations is used to calculate the total quantity of gas oil used by the installation. The total quantity of gas oil used by the installation is used to calculate and record emissions from this source stream using formulas in an Excel spreadsheet.

The CO2 emission is calculated on an annual basis as the product of Activity x Net Calorific Value x Emission Factor x Oxidation factor.

Submit relevant documents to record data flow activities


N/A N/A

bb. Assessing and Controlling Risks

Details of the procedures used to assess inherent risks and control risks in accordance with Article 58 of the MRR:



Describes how assessments of inherent risks and control risks are undertaken when establishing the control system. Outlays the requirement for assessments QA/QC checks to be carried out prior to submitting annual reports and plans to the EPA.



Location where records are kept EHS officeName of IT system used CORALList of EN or other standards applied N/A

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cc. Quality Assurance of Metering / Measuring Equipment

Details of the procedures used to ensure quality assurance of measuring equipment in accordance with Article 58 and 59 of the MRR.



Outlines requirement to contact fuel vendors for calibration certificates/information on gas meters and diesel measuring devices at regular intervals.



Location where records are kept Environmental, Health and Safety DepartmentName of IT system used CORALList of EN or other standards applied N/A

dd. Quality Assurance of Information Technology used for Data Flow Activities

Details of the procedures used to ensure quality assurance of information technology used for data flow activities in accordance with Article 58 and 60 of the MRR:



Identifies how information technology is controlled, including access control, back-up, recovery and security.




ee. Review and Validation of Data

Details of the procedures used to ensure regular internal reviews and validation of data in accordance with Articles 58 and 62 of the MRR.



Identifies what the review and validation process includes. A check on whether data is complete, comparisons with data over previous years, comparison of fuel consumption reported and factors obtained from fuel suppliers. Outlines the requirements for assessments to be carried out prior to submitting annual reports and plans to the EPA.



Location where records are kept Environmental, Health and Safety DepartmentName of IT system used CORAL

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List of EN or other standards applied N/A

ff. Corrections and Corrective Actions

Details of the procedures used to handle corrections and corrective actions in accordance with Articles 58 and 63 of the MRR:



Outlines what appropriate actions are undertaken if data flow activities and control activities are found not to function effectively. How the validity of the outputs are assessed, the process of determining and addressing the cause of the error. Outlines the assessments to be carried out prior to submitting annual reports and plans to the EPA.



Location where records are kept EHS OfficeName of IT system used CORALList of EN or other standards applied N/A

gg. Control of Outsourced Activities

Details of the procedures used to control outsourced processes in accordance with Articles 59 and 64 of the MRR.



The metering of natural gas is carried out by Bord Gais Networks (BGN) at the Above Ground Installation (AGI) on site. BGN maintain and operate the AGI including the calibration of all metering equipment elements of which are calibrated annually and a report sent to site. BGN Code of Operations, Part G (Version 3.0) documents information on their measurement equipment including how it is verified and maintained.

Gas Oil and Kerosene is metered during delivery by meters on the delivery trucks. These meters are examined and tested by Legal Metrology Service who certifies that the instruments conform to the requirements of the Metrology Acts and that the standards used to perform the tests are traceable to National Standards.




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hh. Record Keeping and Documentation

Details of the procedures used to manage record keeping and documentation:



Specifies requirement to retain invoices/dockets on file for 10 years after reporting period in accordance with Annex IX

of the MRR and to how the data is stored such that the data is made readily available upon request.



Location where records are kept Environmental, Health and Safety DepartmentName of IT system used CORALList of EN or other standards applied n/a

ii. Risk Assessment

The results of a risk assessment that demonstrates that the control activities and procedures are commensurate with the risks identified:


N/A N/A

jj. Environmental Management System

Does your organisation have a documented Environmental Management System?

Yes

Is the Environmental Management System certified by an accredited organisation?

No

12. Changes in Operation

kk. Changes in Operation

Article 24(1) of Commission Decision 2011/278/EC requires that Member States must ensure that all relevant information about any planned or effective changes to the capacity activity level and operation of an installation is submitted by the operator to the competent authority by 31 December each year. Article 12(3) of the MRR further provides that Member States may require information to be included in the monitoring plan of an installation for the purposes of meeting these requirements.

Details of the procedure used to ensure regular reviews are carried out to identify any planned or effective changes to the capacity activity level and operation of the installation that have an impact on the installation's allocation:

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The procedure specified below cover the following:

planning and carrying out regular checks to determine whether any planned or effective changes to the capacity activity level and operation of an installation are relevant under Commission Decision 2011/278/EC; and

Procedures to ensure such information is submitted to the competent authority by 31 December of each year.

Title of procedure Management of EHS licencesReference for procedure BEHS68Diagram reference n/aBrief description of procedure. The description should cover the essential parameters and operations performed

This procedure covers the the process for the management and control of EHS permits and licences and specifies the reporting and monitoring requirements defined in the permits and licences held by Allergan Pharmaceuticals Ireland. This procedure requires any installation changes/alterations to be notified to the EPA e.g. a significant capacity extension, a significant capacity reduction, cessation of operation or partial cessation of operation.


EHS Department

Location where records are kept CORAL documentum systemName of IT system used CORAL documentum system

13. Abbreviations

ll. Abbreviations Acronyms or definitions

Abbreviations acronyms or definitions that have been used in this monitoring plan:

Abbreviation Definition

N/A N/A

14. Additional Information

Any other information:


Metering Uncertainty Calculations Allergan.docx Determination of gas meter uncertainty

Allergan gas meter test 12-Apr-2012 (3).pdf Gas meter test cert from 2012

Allergan Gas meter 16052011.pdf Gas test report

Allergan_GHG153_ETS014_Feb_2013.pdf Change of Operator Details

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15. Confidentiality

mm. Confidentiality Statement

It is the Environmental Protection Agency's policy to make information received by it in the course of its work open to inspection by any person on request. This is in accordance with the provisions of the European Communities (Access to Information on the Environment) Regulations 2007 to 2011.

In the event that you considered that some of the information being submitted of a confidential nature, then the nature of this information and the reasons why it should be considered confidential, with reference to the European Communities (Access to Information on the Environment) Regulations 2007 to 2011 and any amendments must be explicitly requested using the facility below. The Board of the Environmental Protection Agency will consider the requests and if the information can be deemed as confidential and necessary.

Notwithstanding any request for confidentiality, the Environmental Protection Agency explicitly reserves the right to release data to the Commission, including emissions and allocations to the public, on the basis that the data will be used for the purposes foreseen in Directive 2003/87/EC of the European Parliament and of the Council of 13 October 2003 establishing a scheme for greenhouse gas emission allowance trading within the Community and amending Council Directive 96/61/EC.

Please tick this box if you consider that any part of your form should be treated as commercially confidential/sensitive:

false

END of Appendix I.

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Site Notice

Application to the Environmental Protection Agency for the Review of a Licence.

Notice is hereby given in accordance with section 87(1)(a) of the Environmental Protection Agency Acts 1992 and 2003, that Allergan Pharmaceuticals Ireland, Castlebar Road, Westport, County Mayo, (National Grid Reference 100532, 284990) is applying to the Environmental Protection Agency for a review of the site’s Licence P0126-02, under:

Class 5.16: The production of pharmaceutical products including intermediates; and

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

The application is accompanied by an environmental impact statement (EIS) which is submitted to the Agency and has been previously submitted to Mayo County Council (Planning Reference P12/451) on the 28th of August 2012.

A copy of the application for the licence, the Environmental Impact Statement and such further information relating to the application as may be furnished to the Agency in the course of the Agency’s consideration of the application will, as soon as practicable after receipt by the Agency, be available for inspection or purchase at the headquarters of the Agency (Tel: Local 1890 33 55 99 or 053-60600) or alternatively via the Agency’s website.

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Site Notice -

attached to fence

GRID REFERENCE:

100532, 284990

Future Works

Extension to Site

(Black Outline)

Drawn by:

Checked by:

Approved by:

Scale:

Date:

Job No:

File No:

Rev:

MDE1096SK1002A01

Drg. No:

Title:Project:

No. Date Amendment / Issue

A

p

p

.

D

r

n

.

1. This drawing is the property of RPS,

it is a confidential document and must not be copied,

used, or its content divulged without prior written consent.

2. All Levels refer to Ordnance Survey Datum, Malin Head.

3. DO NOT SCALE, use figured dimensions only,

if in doubt ask.

NOTES

Client:

App.

RPS , West Pier Business Campus,

Dún Laoghaire, Co. Dublin, Ireland.

T: +353 1 288 4499 - F: +353 1 283 5676

E: [email protected] W: www.rpsgroup.com/ireland

Ordnance Survey Ireland Licence No. EN0005013

©Ordnance of Survey, Ireland and Government of Ireland

LEGEND

Allergen Pharmaceuticals

Site Boundary

Site Boundary Plan,

with Site Notice Location

DB

MR

PC

1/2,500 @ A3

13/03/13

MDE1096

Drawing 2 A01

A01 13/03/13 Issue for Approval

M

R

D

B

PC

50m SCALE 1:2500

Site Notice Location

CO. MAYO

Westport

OS REFERENCE: 2079-A

Note: Existing Plant in grey outline

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Attachment C.1 – Site Management and Control

This attachment deals with the site management structure of the operation, specifically in relation to on-site abatement/treatment systems and includes details of personnel training and qualifications. C.1.1 - Management Structure and Responsibilities

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C.1.2 - Management of Treatment and Abatement Syste ms The Utilities Manager and Facilities Manager (under Director Technical Services) are responsible for the operation and control of treatment and abatement systems onsite. The Utilities and Facilities Manager are supported in this role by the Maintenance Manager (under Director of Technical Services) and Facilities Manager. The responsibilities, training and qualifications are listed in table below: Table C.1.2.A: Responsibilities and Training for Co ntrol of Abatement/Treatment Systems

Responsible Responsibilities Training/ Qualifications

Director of Technical Services

Ensure that all Functions on site are fully managed and supported by Maintenance, Information Services, Facilities, Utilities, Janitorial and compliance to EHS. Assures that all systems are operating effectively and in accordance with all Quality systems, regulatory and Corporate requirements. Provide Technical Services support to further expansions and projects. Achieve the company’s stated quality objectives for GMP and EHS through continuous improvement efforts and conformance to quality standards. Maintains and implements the quality policy and quality objectives.

BSc. Env; MSc Eng

Maintenance Manager (under Director of Technical Services)

Plans, organises and manages the maintenance of the facility, production machinery/equipment and general plant to meet regulatory standards and quality requirements

Junior & Senior trades City & Guilds-PTI

Utilities Manager (under Director of Technical Services)

Manages utilities at the site: HVAC, lighting, heating, site access, ground management.

National Certificate in Mechanical Engineering (NCEA)

Facilities Manager (under Director of Technical Services)

Manages facilities at the site including fire system, water systems, building management systems

N/a

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C.1.3 - Calibration and Maintenance Systems Allergan Pharmaceuticals Ireland has implemented a procedure for calibration and maintenance of environmental monitoring equipment onsite. The control of equipment servicing and calibration frequency of all EHS monitoring and analysis equipment is controlled under the Standard Operating Procedure (SOP) BEHS 59. This procedure is available upon request. The validations department onsite equipment database ‘Blue Mountain’ contains all the EHS equipment and the frequency with which calibration is required. At the beginning of each month the ‘Blue Mountain’ system notifies the department technician via electronic mail with a list of servicing/calibrations required for the month ahead. It is the responsibility of the department technician to ensure that the outlined servicing/calibrations are performed during this period in accordance with the equipments calibration/service requirements. C.1.4. Waste Control System Allergan Pharmaceuticals Ireland operates a strict waste management and control system, which is defined by documented site-specific Standard Operating Procedures (SOPs), as detailed below. These procedures are reviewed and updated regularly to reflect up-to-date operations on-site. Table C.1.4.A - Site Waste SOPs

Procedure Appendix

BEH35. Waste Management-Role of EHS Janitor Procedure to be followed by EHS Janitors in relation to their role in waste management at Allergan Pharmaceuticals Ireland.

BEH29. Handling, Collection & Disposal of Hazardous chemicals.

Procedure sets out process and responsibilities for hazardous waste classification, storage, dispensing, handling and overall management of waste onsite.

BEHS51. Off site disposal of Hazardous waste Procedure to be followed for the correct off-site disposal of hazardous wastes.

BEHS48. Management of Non-Hazardous Waste Procedure sets out process and responsibilities for non-hazardous waste classification, storage, dispensing, handling and overall management of waste onsite.

BEHS65. The procedure for the disposal of laboratory small/wipes in the Pharma and Botox Laboratories

Procedure to be followed with respect to the collection, storage and disposal of laboratory small/wipes in the E.T.C, Chemistry and Microbiology laboratories.

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C.1.5 - General Outline of Quality Control System It is the policy of Allergan Pharmaceuticals Ireland that the site Quality Systems are intended to assure that all design, development, manufacturing, and distribution activities consistently produce high quality products that meet or exceed customer requirements. Allergan Pharmaceuticals Ireland’s quality policy statement can be found at the end of this attachment. Allergan Pharmaceuticals Ireland is certified to ISO 13485:2003, a standard for quality management systems with requirements for regulatory purposes, specifically designed for medical devices operations. However, all sections of ISO13485:2012 are applicable to the main activities at the Allergan Westport facility. In compliance with the requirements of ISO 13485:2003, the site utilizes a process approach to quality system management. The identification of key corporate processes, their interactions, and the key process metrics support the effectiveness of the quality system. The structure of the quality management system can be described as comprising of seven key elements aimed at a continuous improvement strategy. A brief explanation of each of the key elements within the management system is given below. This information is abstracted from the site Process Manual. Management Controls Management control activities assure that adequate resources are provided throughout the organization to support the quality system. Executive management visibly and actively supports the implementation and maintenance of an effective quality system. Management identifies key quality objectives and periodically reviews progress toward these objectives during Management Review meetings. Production and Process Controls Production and process control activities are implemented to ensure product manufactured meets internal specifications and customer requirements. To achieve this, Allergan Pharmaceuticals Ireland develops processes that produce devices that meet specifications, validate the results of these processes and monitor and control the processes. Document and Data Controls Allergan Pharmaceuticals Ireland maintains a documented quality system to ensure that its activities result in the development and manufacture of products that meet its specified requirements and that its quality system complies with ISO 13485:2003 requirements. Allergan establishes and maintains procedures to create, issue, revise, update, distribute, obsolete and control all documents and records related to our quality system, including applicable documents of external origin. Materials Controls Allergan Pharmaceuticals Ireland has documented procedures to ensure that purchased products, materials and services used in their design, development, technology-transfer, manufacture and market support activities conform to specified purchase requirements. Each department that submits a purchase request is responsible to ensure that the vendor selected is approved, if applicable, and that material requested is clear and unambiguous. All special requirements for the order must be provided. Verification of conformity to specified requirements is performed on all purchased material required for investigational manufacture and product consumer manufacture, before it is released for processing, and must be according to documented procedures.

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Design Controls Design control activities ensure that devices meet user needs, intended uses, and specified requirements. The design control process encompasses all phases of design and establishes the safety and effectiveness of the device. Corrective and Preventive Action (CAPA) Allergan Pharmaceuticals Ireland establishes and maintains programs for both investigational and consumer products that investigate the root cause of non-conformances and determine effective corrective action so that they do not recur. Allergan Pharmaceuticals Ireland also supports the establishment and maintenance of preventive action programs that will eliminate the causes of potential non-conformances in order to prevent their occurrence. Identification and Traceability Allergan Pharmaceuticals Ireland ensures identification and traceability of materials, supplies and products by relating to applicable technical specification documents for individual components, products, batches and lots.

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Document Name:

Document Title:

Justification(MM/DD/YYYY HH:MI:SS format)

Signed By Date/Time (PT-Pacific Time)

PM - Quality Policy

04/16/2013 12:32:16 Walsh_Louise Westport QA/QC ApprovalTreacy_Tom02/27/2013 06:49:03 Westport QA/QC Approval

WE-PM002

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Allergan Pharmaceuticals IrelandProcess ManualIREPM-02-001

SECTION: _____PM02_____ SUBJECT: Quality Policy

Allergan Pharmaceuticals Ireland has generated a site specific Quality Policy which is based on the Allergan Corporate Quality Policy as detailed in the WWQA Quality Manual AGNMAN-01-000.

Allergan Corporate Quality Policy:

Allergan is committed to provide safe and effective products that meet our customers’ needs through operating and continuously improving a world-class Quality Management System.

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Allergan Pharmaceuticals IrelandProcess ManualIREPM-02-001

SECTION: _____PM02_____ SUBJECT: Quality Policy

Allergan Pharmaceuticals Ireland Quality Policy

As a speciality drug and device company, manufacturing ophthalmic and Biological products,Allergan is committed to proactively responding to the voice of the customer.We are focused on sustaining and enhancing regulatory compliance by adhering to our QualityManagement System and the maintenance of its effectiveness. Allergan, as an innovativecompany, is focused on the development of its people, products and technologies.

Signed copies of the Quality Policy are posted at the following locations:

Entrance at both Reception Areas Entrance at New Offices Entrance at the South East Corner Maintenance Workshop Entrance at the back offices Director, QA’s Office Entrance to the Microbiology Department Entrance to the Chemistry / ETC Laboratories Multi-Dose Packaging Botox Canteen

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Document Name:

Document Title:



Register of EHS & Energy Legislation, Communications and Complaints

11/05/2013 08:49:00 Conneally_Sinead Westport EHS ApprovalQuinn_Thomas210/31/2013 08:04:02 Westport EHS Approval

BEHS69

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STANDARD OPERATING PROCEDURE

DEPARTMENT Environmental Health & Safety

SOP #: BEHS69

TITLE/DESCRIPTION:Register of EHS & Energy Legislation, Communications and Complaints

1.0 PURPOSE

1.1 The purpose of this SOP is to outline the procedure by which all communications with employees, customers, media, interested groups will be handled and specifies how Allergan deals with community complaints on Environmental, Energy, Health and Safety Issues.

1.2 To ensure that the Register of EHS and Energy legislation is kept up to date and reviewed at quarterly intervals by EHS Personnel.

2.0 SUPERSEDES

2.1 BEHS69 Version 5.0, Register of EHS & Energy Legislation, Communications and Complaints”.

3.0 RESPONSIBILITY

3.1 It is the responsibility of the Vice President and Managing Director, the Director of Human Resources and the Director of Site Technical Servicesto ensure that Allergan Pharmaceuticals Ireland communicates with stakeholders on matters relating to EHS and Energy issues in an effective and efficient manner.

3.2 It is the responsibility of the Director of Site Technical Services and EHS team to ensure implementation of any new legislation requirements.

4.0 FOR USE BY / DISTRIBUTION

4.1 GTOPS_WE_VP_MDGTOPS_WE_DIRSGTOPS_WE_EHS_DEPTGTOPS_WE_HR_MGRGTOPS_WE_PHARM_FACILITIES_MGRGTOPS_WE_UTILITIES_MANAGER

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SOP #: BEHS69


5.0 DEFINITIONS

5.1 Stakeholders: Individuals, companies, suppliers, governing bodies, regulatory bodies, and other members of the community who have an interest in the EHS program at Allergan Pharmaceuticals Ireland.

6.0 PROCEDURE6.1 Employees:

Employees will be communicated to on our EHS program, performance, successes and awards program through providing access to the following:

EHS policy and EHS summary policy document. EHS Goals and Targets. Energy Goals and Targets. EHS Notice boards. Plasma Screens. EHS SOPs. Environmental Management Programme. Green team minutes. Steering committee minutes. Corrective action reports. Safety Committee Minutes. EHS documentation and reports held on public files by regulatory

authorities (i.e. Irish Environmental Protection Agency, Health and Safety Authority and the Local Authority).

Allertus. Corporate magazines and publications (i.e. Insight and EHS reports) Intranet (Allerweb). Internet – www.allergan.com. Email/Notice Board Postings. Internal Meetings. Sharepoint Safestart Card Program. Safety Forums Behavioural Safety Meetings

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SOP #: BEHS69


Note: Any request relating to EHS and energy records must be channeled through the Director, Site Technical Services. The Greenhouse Gas Emissions Permit (Permit No. IE-GHG153), the IPPC Licence (PO126) and reports submitted to the Agency in accordance with the conditions of these permits will be made available to the public or interested parties at all reasonable times. The relevant environmental records can be obtained by writing to Allergan and requesting a copy of the documents or by visiting the site where the records will be provided under the supervision of the Director, Site Technical Services / Designee.

All reports submitted to the Environmental Protection Agency (EPA) in compliance with Allergan's IPPC licence or GHG Permit are a matter of public record and may be obtained by contacting the EPA regional inspectorate in Castlebar.

6.2 Media:

Any request for sensitive information relating to our EHS program, must be referred to the Director of Human Resources and / or the Director, Site Technical Services.

6.3 Customers:

Any sensitive communications with customers on our EHS program will be processed through our Vice President and Managing Director.

The EHS policy will be made available to any customer on request from Reception at Allergan Westport between the hours of 8a.m. and 4.30p.m. Monday to Friday (except holidays).

The following information is made available to customers on www.allergan.com

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SOP #: BEHS69


Corporate EHS Policy EHS Performance (Corporate/Specific Facility)EHS ProgramsMSDS/Product Information for Allergan ProductsSuccess Stories (New technology, cost of being average, energy reductions, Climatewise/Wastewise links)Achievement Awards

6.4 Community/interested parties:

6.4.1 Requests for information on EHS issues will be responded to by the Vice President and Managing Director and Human Resources Director

6.4.2 The relevant documents will be brought to the interested party by the Director, Site Technical Services/delegate.

6.4.3 Documents submitted to the EPA or other regulatory authorities may be photocopied subject to approval by the Director, Site Technical Services. No other documents may be photocopied but notes may be taken.

6.4.4 The Director, Site Technical Services/delegate will be available to interpret the conditions or correspondence shown to the interested party.

6.4.5 Copies of Allergan’s EHS Policy are available by calling to Reception at Allergan’s Westport facility between 8am and 4.30pm Monday to Friday (except holidays).

6.4.6 Communications with Regulatory bodies is addressed in BEHS68Management of EHS Licenses and BEQA23 Regulatory Body Inspections.

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SOP #: BEHS69


6.5 Community Complaints:

6.5.1 All community complaints expressed verbally or in writing are to be addressed by the VP and Managing Director, the Human Resources Director and the Director, Site Technical Services.

6.5.2 If a member of the public contacts the company by telephone, in writing or in person with a complaint, the VP and Managing Director and/or the Human Resources Director and Director, Site Technical Services must be notified immediately. In the event of these people being absent, the most Senior Executive available must be notified.

6.5.3 All information relating to the complaint must be documented in the Community Complaint Form – Addendum 1. All community complaint forms must be held by the EHS Department. In the event that a community complaint is received out of office hours (i.e. between 16.30 pm and 08.00 am), Security personnel must record the name and contact details of the complainant and contact the Director, Site Technical Services as soon as possible.

6.5.4 An investigation into the complaint must be initiated immediately and the complaint resolved as quickly as possible.

6.5.5 External environmental complaints (i.e. from a customer) may be received through the QA Complaint Co-ordinator and may be handled in that system (see BECOM01). The Director, Site Technical Services will review all such complaints.

6.5.6 It is the policy of the company not be make Environmental Complaint Records available to the public because they are deemed company confidential and because of the possibility of legal action.

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SOP #: BEHS69


6.5.8 Any community complaints must be notified to the Corporate Senior Director EHS and Legal within 24hrs of the complaint being received as per Corporate EHS event reporting requirement (Addendum 1).

6.6 Written Communication Plan:

A written EHS and Energy Communications Plan (describing specific activities to be conducted, the target audience and target date for completion) shall be revised and updated by EHS on an annual basis.

6.7 Update and Review of Environmental, Health, Safety and EnergyLegislation.

6.7.1 Allergan Westport subscribes to an independent legislation update service. A quarterly meeting is held by the EHS Team to review legislation updates, and any implications for the site are evaluated. Where relevant, new or revised legislative requirements are implemented.

7.0 FIGURES, TABLES, and/or ATTACHMENTS

7.1 Addendum 1 “Community Complaint Form”.

8.0 REFERENCES

8.1 Integrated Pollution Control License Register No 126.8.2 BEHS68 “Management of EHS Licences”.8.3 BEQA23 “Regulatory Body Inspections”.8.4 BECOM01 “Handling of Complaints for Allergan Ophthalmic Products”.8.5 GHG Permit 153

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SOP #: BEHS69


9.0 REVISION HISTORY

Revision Description

1.0 DCR-00003756

2.0 DCR-00012555

3.0 DCR-00021641

4.0 DCR-00029626

5.0 DCR-00038296

6.0 DCR-00056840

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SOP BEHS69 Addendum 1 Page 1 of 1

Community Complaint Form

Allergan Pharmaceuticals Ireland P0126-02

Date of complaint:

Name of complainant

Address and contact details of complainant

Telephone: _________________________

Type of complaint Odour Noise Other:___________________

Details of complaint

Approximate start time of complaint(Provide range if time is

not known)

Still ongoing? Yes No

Details of who was notified:*Mandatory

*Managing Director *Director, Site Technical Services

*Corporate EHS Director Regulatory Agency ____________

Corrective actions taken:

Preventative actions taken or planned:

SIGNED PRINTNAME

Position

Date:

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Document Name:

Document Title:



Allergan Environmental Health and Safety Policy

06/18/2012 10:01:08 Quinn_Thomas2 Westport EHS ApprovalConneally_Sinead06/18/2012 08:08:37 Westport EHS Approval

Westport Operations Approval06/20/2012 14:10:00 ODonnell_Pat

BEHSPOL002

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ALLERGAN PHARMACEUTICALS IRELAND

ENVIRONMENTAL, HEALTH & SAFETY POLICY

Allergan Pharmaceuticals Ireland is committed to assuring our business practices enhance the welfare of ourcustomers, employees and the communities in which the company operates.

Our overall aim is to maintain a strong Environmental, Health and Safety (EHS) culture within the organisation where each person demonstrates care for one another’s safety, the fostering of an accident free work environment and the protection of the natural environment. Allergan will realise this vision by taking appropriate leadership measures in accordance with this EHS policy charter.

Prevention, Innovation, Sustainability & Continuous Improvement

We are committed to developing and manufacturing products and processes that advocate a safe, injury freeworkplace, minimal environmental impact and protection of natural resources and commitment to energy conservation.

We are committed to continually improving our EHS standards, culture and performance and will establish and implement EHS goals, targets and objectives to continuously refresh and invigorate our systems which underpin the EHS policy.

Compliance

We are committed to full compliance with all applicable EHS Regulatory and Corporate Requirements and will inspect and audit our systems to assure compliance.

Good Citizenship

We will promptly respond to and strive to resolve stakeholder EHS issues. We will foster business agreements with suppliers and contractors to improve EHS Standards and we will ensure that this EHS Policy Statement is available to the public and interested parties.

Policy Implementation & Review

We will communicate, implement and maintain this policy at all levels in the organisation by training and awareness, by integration into our business strategy and management systems and by periodic reviews of EHS management system and practices.

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Document Name:

Document Title:



Environmental Management System Manual

05/08/2013 00:47:01 Quinn_Thomas2 Westport EHS ApprovalConneally_Sinead05/07/2013 12:48:28 Westport EHS Approval

BEHSPOL004

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WESTPORT, IRELANDEHS QUALITY MANUAL

Allergan EMS Manual

1

Distribution: EHS

Environmental Management System

Allergan Pharmaceuticals IrelandWestport, Ireland

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Allergan EMS Manual

2

Table of Contents:

Section Number:

Name: Page:

1.0 Environmental Management System 32.0 Management Commitment 43.0 General Review 54.1 EHS Policy 54.2 Planning 64.2.1 Environmental Aspects 64.2.2 Legal and other Requirements 74.2.3 Environmental Management Program 84.3 Implementation and Operation 84.3.1 Structure and Responsibility 84.3.2 Training, Awareness and Competence 104.3.3 Communication 114.3.4 Documentation 114.3.5 Document Control 114.3.6 Operational Control 124.3.7 Emergency Preparedness and response 124.4 Checking and Corrective action 134.4.1 Monitoring and Measurement 134.4.2 Non Conformance and Corrective and Preventative Action 134.4.3 Environmental Records 144.4.4 Environmental Audits 144.5 Management Review 15

Appendix 1 : EHS Policy 17Appendix 2 : List of relevant S.O.P’s 19Appendix 3 : EMS organisation 20

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Allergan EMS Manual

3

1.0 Environmental Management System.

Allergan Pharmaceuticals Ireland has implemented an Environmental Management System to enable a focused and documented approach to environmental performance and improvement. Although not an accredited system, it is based on a system of continuous improvement and aims to tie in with the existing ISO quality system in the plant.

Environmental protection is a very important consideration in the management of the Allergan Westport facility. The EMS evaluates and reviews the environmental impacts contributed by the facility and assigns actions to address them in accordance with the significance of the impact. The EMS aims to create a systematic plan for making changes that improve our environmental performance.

The EMS also provides for a network of employees in departments across the plant (‘Green Teams’) who focus on environmental issues within the department of origin, and bring a team-based approach to enhancing environmental protection. Training and information, a key component of the EMS at Allergan Westport, ensures that all employees understand the contribution the facility makes to the total environmental loading, and the potential they have for improving that aspect.

The specific details regarding the operation of the system are integrated into the overall organization of the plant, and may be found in SOP’s and other documentation elsewhere, however the main elements of the system are outlined in this EMS Manual.

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Allergan EMS Manual

4

2.0 Management Commitment.

Corporate Commitment:

There are three EHS specialists in the Corporate EHS Group dedicated to the management of environmental affairs and pursurance of environmental leadership. It is recognised that this must be supported by the Corporate organisation if the system is to be successful. This commitment has been gained at an early stage from Corporate by the management activities of the Corporate EHS group who actively promote excellence in environmental performance throughout all the Allergan organizations. Their role ensures that environmental issues are brought up at management forums within the Corporation as relevant, and can review the performance and resources assigned to the area within individual plants. To formalise and promote this system, they have devised an Environmental Achievements Programme, which is policed by a Corporate EHS audit. Corporate EHS not only support, but also expect a high level of performance in environmental management and in implementing an EMS. The Chief Executive Officer of the Corporation takes a keen interest in the environmental affairs within individual plants and reviews Corporate audit performance results from individual sites. The Commitment of Allergan Corporate to EMS is clear. The Corporate EHS Vision statement reads:“We will take the environment into account in all that we do”.

Plant Commitment:

Allergan Westport is committed to ensuring compliance with environmental regulatory requirements. Senior Management recognise that implementation of an EMS is a key step in assuring an effective environmental system. Environmental Control is an integral part of the Strategic Goals set at the Westport plant. Strategic Goals are formulated by senior management at the site and approved by the Corporate organisation.

Environmental issues are discussed regularly at Director meetings, and the Managing Director jointly with the Technical Services Director play an active role in highlighting such items as priority issues. The facility management teamare mindful that the plant is located in a very scenic, high tourist amenity area, where environmental protection is of a particularly sensitive nature.

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Allergan EMS Manual

5

The Allergan Westport facility has developed and maintainesa good relationship with the local community. As outlined in SOP BEHS69, community complaints are treated as a priority issue by Senior Management.

As part of the Allergan Westport objective, we aim to be EHS leaders in the community. Management commitment to environmental issues is further outlined by the amount of capital expenditure dedicated to environmental projects.

The EHS Department is comprised of three team members responsible formanaging environmental programs and enabling leadership levels of performance to be achieved. Two additional employees are involved in handling wastes prior to removal from site for disposal/ recovery activities.External consultants are contracted when deemed necessary to provide specific expertise. An overview of the EMS structure is given in Appendix 3.

3.0 General Review:

It was recognised that in order for environmental effects to be assessed it is required that they are firstly adequately identified. The review was carried out in order to identify the aspects of the organisation’s operations which might impact the environment. In order to ensure a thorough review, it was carried out on a department by department basis. This has allowed the environmental effects of individual departments to be identified. The flow of the product was followed and the main processes involved have been analysed to determine the emissions which arise or the materials used. Emissions were detailed with respect to the environmental media to which they occur - air, wastewater, solid waste, hazardous waste etc.

The environmental review is then translated into a register of environmental effects which is published in this document.

4.0 Environmental Management System requirements

4.1 Environmental, Health and Safety Policy:

The Plant Environmental, Health and Safety policy encompasses the Corporate EHS policy, but also details the intentions and principles of action of the Westport site, in relation to its EMS. It outlines the system to be used to give rise to the Plant’s objectives and targets.

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Allergan EMS Manual

6

The policy is relevant to the plant activities, processes, products and services and their environmental effects and it calls for continual review & evaluation of operations to ensure that these activities are included in the EMS.

Management ensure that the policy is understood, implemented and maintained at all levels of the organization by ensuring that employees, contractors and stakeholders have been made aware and trained on the main points of the policy. Copies of the policy are available in Reception for employees/interested parties and framed copies have been positioned in Reception, at the main employee entrance, on the packaging corridor, and in Botox. The policy is publicly available and has been made available to the the EPA, the Local Authorities and the local Chamber of Commerce. See Appendix 1, BEHSPOL004 EHS Policy.

The policy is subject to regular reviews and updates at EHS Steering Committee meetings, as are other elements of the EMS.

4.2 Planning

4.2.1 Environmental Aspects.

In order to identify the environmental aspects of the plant and to determine thosethat have/can have significant impacts on the environment, a review of activities and their interaction with the environment was initially carried out in 1994 and is detailed in the EMS Departmental Overview document.

Operational change and programmes for developments including capital expenditure developments are assessed for environmental significance by the Change Control Committee which includes the EHS Supervisor. The EHS Supervisor can specify action required as relevant to the EMS. All new developments must go through the Change Control process as per BEQA15.

New product developments, modifications to existing products including packaging and phase out of existing products are controlled by Allergan Corporate. All new products developed are put through an ‘Environmental Product Design Criteria’ assessment by Corporate EHS, so that environmentally unacceptable options are screened out at an early stage. Transition of existing products from other plants involves the participation of Allergan Corporate, the site EHS Supervisor and the site Manufacturing Support Manager. The Operations transition process requires completion of an EHS review (As outlined in SOP BEHS09), with signoff by EHS Supervisor, before a product can be scaled up to production level.

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Allergan EMS Manual

7

The Technical Services Department annual projects are summarised on the Capital Budget. The EHS Supervisor/Manager receives a copy of this budget ensuring that each project is reviewed by EHS. This is referenced in the Environmental Management Programme. The EHS Supervisor/Manager reviews and signs off on Capital Expenditures (CE’s).

Review of the environmental impacts is an ongoing process and the method used is detailed in SOP EHS38 “Review of the Environmental Effects at Allergan”

The environmental impacts of the Facility were evaluated in the Register of Environmental Effects and an assessment as to the significance of the effects was made.

Significant impacts have been classified as Level I, Level II and Level III in order of the extent of their significance - Level I effects being those most significant and requiring priority action. A further level, Level IV has been designated as those which are not significant but require some action to ensure that the effects remain insignificant.

Classification of Environmental ImpactsLevel I Most significantLevel II Intermediate significanceLevel III Lesser significanceLevel IV Not significant

An assessment of the effect is made by measuring against a series of pointers which allocate the effect into one of the IV categories of Significance. Impacts initially were reviewed by the EHS Manager and approved by the Director responsible for EHS. Thereafter, review takes place as detailed above by the EHS Manager.

4.2.2 Legal and other requirements

A Register of Legislation is available which identifies the regulatory requirements that Allergan Pharmaceuticals Ireland must comply with. This register is reviewed at regular intervals. Details of new legislation introduced in Ireland and the EU can also be found in the Environmental Bulletin, Health & Safety Review and on the EPA/ HSA websites. An on-line legislation service is provided to Allergan by Scannell Solutions.

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Allergan EMS Manual

8

Allergan Pharmaceuticals Ireland Westport is licenced under Integrated Pollution Prevention Control Licence (IPPCL) P0126-02 which is issued and enforced by the Environmental Protection Agency. Allergan Westport must adhere to all the conditions of this licence and is regularly audited by the Agency. In addition, the site also holds a Greenhouse Gas permit thus controlling the emission of carbon dioxide to atmosphere. Both the IPPC licence and GHG permit have monitoring and reporting requirements which must be complied with.

4.2.3 Environmental Management Program

The Environmental Management Program (EMP) outlines the facility’s environmental objectives and targets and contains the actions to be taken to address the significant impacts identified in the Register of Effects, the means by which the objectives are achieved, the timeframe and the person responsible. Based on the Register of Effects it relates to steps to be taken by Allergan to reduce /eliminate Allergans significant impacts previously identified.

An ongoing review of the EMP and progress achieved in the programmes is carried out by the EHS Manager. Timeframes and responsibilities for any follow up work required will be recorded.

All new products, processes, goods and services are reviewed prior to implementation/use – see Section 4.3.1. Where significant impacts are identified steps to reduce/eliminate them will be identified at that time and included in the EMP. The EMP is reviewed and updated annually by the EHS manager and a copy of this program is sent to the EPA as part of the Annual Environmental Report (AER).

In determining the action to be carried out, the general principles of environmental control have been adopted:

Reduction of waste generation at source/ reduction energy use at source Reuse of material/ waste Recycling of material/ waste Effective safe treatment and disposal of non-recoverable material Minimisation of environmental effects of products.

These general principles have been echoed in the plant EHS policy and in departmental environmental training programmes.

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Allergan EMS Manual

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4.3 Implementation and Operation

4.3.1 Structure and Responsibilities.

The environmental organization of the plant is as given in the Organogram Appendix 3.The Managing Director has ultimate responsibility for the environmental management of the facility. The Technical Services Director is responsible for the management of the EMS with the EHS Supervisor responsible for ensuring that the requirements of the EMS are implemented and maintained.

The EHS Supervisor/Manager is a qualified EHS Specialist with experience in all aspects of pollution control and environmental management within the Pharmaceutical industry. Details of all qualifications and training of the EHS Manager/Supervisor are available in the personnel training record.

The Register of Responsibilities clearly lays down the responsibilities incumbent on each relevant employee, including the general responsibilities on every employee in the plant. Position descriptions include environmental responsibilities for relevant personnel.

Standard Operating Procedures (SOP’s) also indicate responsibilities for specific environmental tasks.

Line Management is responsible for implementation of EMS within their department.

Within departments, a “Green team” has been established to focus on and help to ensure the implementation of the EMS within the department. Initially the focus of the team is to achieve awareness as regards environmental issues and controls, but its objectives also include review of environmental issues at an operational level in order to establish further objectives and targets in relation to environmental improvement within the Department. Waste Janitors have also been established in some Departments - a dedicated person whose efforts are directed at ensuring that waste management systems are operational as intended, and that personnel in the area, particularly new personnel are made aware of departmental and plant rules for waste disposal. This organization also makes it easier to follow up on any day to day problems/ issues with the waste management system. This Green team reports to Line Management, but is co-ordinated and overseen by the EMS Manager.

From a Corporate perspective, the EHS Manager/Supervisor reports to the Corporate EHS team and has regular communication with the Corporate Director of Environment, Health and Safety, the Corporate Manager of Health & Safety and Corporate Manager of EHS Compliance.

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Allergan EMS Manual

10

Both the Technical Services Director and the EHS Supervisor/Manager are members of the EHS Steering Committee and have regular communication with the Managing Director in relation to Environmental issues.

4.3.2 Training, awareness and competence:Environmental awareness and training is achieved by:

1) Induction training for new employees:The induction training programme contains a section on environmental, which is presented by EHS. This ensures that environmental issues are communicated to employees and that employees are made aware of their environmental responsibilities. Other department training programmes and awareness sessions will build on this foundation.

2) Company Magazine:‘Alertus’ the company magazine is regularly used to promote awareness on environmental issues, initiatives and news items throughout the plant.

3) Notice boards and Canteen plasma screen:Notice boards and Canteen plasma screens are used for promoting awareness in relation to general environmental issues within the plant.

4) Departmental training programme:There is an individual environmental departmental training programme for each department which explains the EHS Policy & objectives,outlines IPPC requirements and the environmental effects of the department. The important departmental effects and their controls are explained together with the consequences of not adhering to these controls.

It is the philosophy of Allergan Management that the most appropriate way to ensure that each employee is aware of, and supportive of the EMS is by indicating how his department, and how aspects of his job can affect the environment, and how all the departmental aspects combine to produce the overall plant effect. In this way the contributions that individuals can make to the total plant impact can be highlighted.

5) Departmental meetings:Departmental meetings are used to bring specified issues to the attention of all within a department. These meetings are used for promoting awareness in relation to environmental issues as they arise.

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6) Communications programmes:Plant wide communications programmes are carried out on a twice yearly basis. The more significant aspects of the business are communicated to all employees in this manner. These programmes can be used to heighten awareness in relation to environmental issues.

7) Environmental focus days/ weeks:Awareness can also be promoted by environmental days such as Earth Day. Competitions, such as the competition for the Allergan environmental logo may be run. Prizes may be offered for such competitions.

8) Individual job training:Individual job training on environmental aspects is carried out as necessary. Aspects of this may be incorporated into Departmental SOP’s and these may be used to carry out such training.

9) Public concerns:Corporate-driven programmes may focus on environmental issues in the public and customer domain.

10) Allergan Website:There is a signiciant amount of information relating to Allergan’s Environmental program available on the Allergan website.

4.3.3 Communication

Allergan Pharmaceuticals Ireland has reviewed processes for external communication of our significant impacts and as a result implemented a program to deal with communications from external interested parties. This program is detailed in SOP BEHS69.

Relevant environmental information/notices are communicated to all employees by means of notice boards, e-mail and employee meetings. Information may also be communicated during training sessions and environmental awareness days.

4.3.4 Environmental Management Documentation:

Allergan Pharmaceutcials Ireland has reviewed all systems with regard to environmental control and as a result of this, has established several documents for the control of the EMS. A list of these is available in Appendix 2. These documents, including this manual describe the system of environmental control established by the implementation of an EMS.

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4.3.5 Document Control

Environmental documentation is controlled as described in SOP DCC10. This ensures that documentation is easily identified, reviewed as necessary, that current versions are available and obsolete documents removed as necessary. The EMS documentation will be reviewed annually as part of the management review but may be changed at any time as a result of audit reports, processchange, legislation change or as a result of corrective actions.

Obsolete EMS documentation will be maintained for seven years. All planning permissions and licenses will be maintained for the lifetime of the plant.Identification, locations and retention times of all environmental documentation is listed in DCC29.

4.3.6 Operational Control

Operational control has been reviewed on a departmental basis as it relates to processes/ activities having the potential to affect the environment. The critical areas for operational control have been identified, and control systems together with verification systems have been designated for them. A single SOP has been documented per department, which summarises the environmental control systems within the department. Management responsibilities in relation to this have been included in SOP’s. See Appendix 2 for list of Departmental SOPs.

Operational changes and new products are controlled as previously described inSection 4.3.1

EHS responsibilities in relation to monitoring and control of environmental emissions have been laid down in SOPs. See Appendix 2 for this list of SOP’s. Criteria for performance is documented in the relevant SOP if this is deemed necessary. The most significant criteria for performance are the Threshold Limit Values in the IPPC licence.

Management requirements for contractors are outlined in SOP BEQA42.

Key Non Inventory suppliers are approved by the maintenance of an approved vendor’s list (see EPU06 ‘Control of Approved Vendors for key non-inventory purchases and services’). Approved chemical list is generated by Allergan Irvine, who have implemented a Supplier Certification Program (developed by Corporate Purchasing with input from Corporate EHS). To date, Corporate EHS have audited some of the new product active ingredient suppliers - audit reports are available at Corporate

There is an EHS questionnaire for use in Packaging Vendor Approvals, which is given in SOP BEQA43 (Vendor Approval & Certification Procedure).

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4.3.7 Emergency Preparedness and Response

Emergency preparedness is actuated through well designed processes and inclusion of safe systems of work in Standard Operating Procedures. Risk assessments have been carried out where required in relation to developments in the past of environmental and safety concern.

The site Emergency Response Plan (WE-EHS-P015) lays down the response to be carried out in relation to emergencies, and outlines the organization in relation to emergencies. There are two communicating emergency groups who assemble on sounding of the emergency alarm - the Plant Emergency Organization (PEO) which are the first line response to the immediate crisis and the Co-ordinated Emergency Response Team (CERT) which deal with the larger issues of the crisis management.

A planned evacuation takes place at least annually. A list of emergency assembly points is also outlined in BEHS16.

4.4 Checking and Corrective Action

4.4.1 Monitoring and Measurement

Verification procedures for critical controls are indicated in the relevant SOP, listed in addendum 2. Internal departmental verifications are carried out to establish weaknesses or otherwise in control systems, which the Departmental staff themselves will action. Further verification activities are carried out by the EHS Department in their monitoring programmes in relation to IPPClicence. The acceptance criteria in relation to this monitoring is given in theIPPC Licence.

The Corrective Action Procedure is initiated where the specified requirements in relation to EHS monitoring are not met. Internal inspections/ audits also serve as verification systems in relation to operational performance.

Records of waste disposal, recycled/reused materials, oil and electricity consumption are maintained as per relevant SOPs. Energy and water consumption are also tracked.

A full review of all documents, reports and results takes place yearly at the Management Review. Critical plant equipment is maintained on a Preventative Maintenance System, and instrumentation in relation to environmental monitoring/ control is calibrated as required (Refer to BEHS59).

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4.4.2 Non conformance and Corrective and Preventative action:

Corrective and Preventative action is applied to the EMS on an ongoing basis. The primary reason for issuing deviations and EHS Incident Reports on QMS include but are not limited to: elevated emission monitoring results, potential or actual contamination of waste streams, audit follow up, EHS Meetings and Management Reviews, review of the Environmental Management Programme. Corrective action is also applied in response to communications re complaints.

This procedure is aimed at determining the root cause of the incident, implementing corrective action and preventing recurrance. It also calls for testing of the efficacy of the controls implemented. The procedure is detailed in SOP BEQA25.

4.4.3 Environmental Management Records:

Environmental Management Records are maintained and kept within individual departments as relevant to the department itself. These records may include logbooks, check sheets etc. Drawings, planning permissions and other facilities related documentation are kept by the Engineering Department. Plant records relating to environmental monitoring are kept by the Engineering and Facilities Department and EHS department. These records may include the following:

Wastewater monitoring results Surface water monitoring results Groundwater monitoring results Noise monitoring records Hazardous waste disposal records Non-hazardous waste summary quantities Copies of waste vendor permits/ licences EHS audit reports Corrective action reports Mercury treatment system records Environmental Incident Reports Annual Environmental Reports Community complaint responses Records recording the extent to which planned environmental objectives/

targets have been met.

Training records are kept electronically on a computerised system called LMSwhich is maintained by the Human Resources Department,

Retention times for the relevant records are documented, as are the method by which these records be kept.

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4.4.4 Environmental Management System Audits:

Environmental Management System Audits are carried out by the following means:- Corporate EHS audits- Formal EHS Audits/ walkabouts- Regulatory Audits and Inspections

Periodic audits involving external consultants may also be carried out. SOP BEHS07 outlines the procedure for plant EHS internal audits.

Follow up action on any audit recommendations is the responsibility of the Departmental Managers.

4.5 Environmental Health and Safety Management System Reviews:

EMS reviews are carried out by the EHS Steering committee. They are carried out at least annually, and are documented. They review all elements of the EMS and assess its performance against its objectives. SOP BEHS39 “Review of the Environmental, Health & Safety Management Systems at Allergan Pharmaceuticals Ireland” outlines the procedure for carrying out EHS reviews.

An annual environmental report (AER) must be compiled as part of our IPPC licensing obligations. As part of the AER, a PER (Pollution Emission Register) must also be included as well as a summary of the Environmental Management Program Plan for the forthcoming year. The AER will be made available within the company and to the public if requested (Refer to BEHS69).

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APPENDICES

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Appendix 1

ALLERGAN PHARMACEUTICALS IRELANDENVIRONMENTAL, HEALTH & SAFETY POLICY

Allergan Pharmaceuticals Ireland is committed to assuring our business practices enhance the welfare of our customers, employees and the communities in which the company operates.Our overall aim is to maintain a strong Environmental, Health and Safety (EHS) culture within the organisation where each person demonstrates care for one another’s safety, the fostering of an accident free work environment and the protection of the natural environment. Allergan will realise this vision by taking appropriate leadershipmeasures in accordance with this EHS policy charter.

Prevention, Innovation, Sustainability & Continuous ImprovementWe are committed to developing and manufacturing products and processes that advocate a safe, injury free workplace, minimal environmental impact and protection of natural resources and commitment to energy conservation.We are committed to continually improving our EHS standards, culture and performance and will establish and implement EHS goals, targets and objectives to continuously refresh and invigorate our systems which underpin the EHS policy.

ComplianceWe are committed to full compliance with all applicable EHS Regulatory and Corporate Requirements and will inspect and audit our systems to assure compliance.

Good CitizenshipWe will promptly respond to and strive to resolve stakeholder EHS issues. We will foster business agreements with suppliers and contractors to improve EHS Standards and we will ensure that this EHS Policy Statement is available to the public and interested parties.

Policy Implementation & ReviewWe will communicate, implement and maintain this policy at all levels in the organisation by training and awareness, by integration into our business strategy and management systems and by periodic reviews of EHS management system and practices.

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Appendix 2:List of relevant SOP’s outlining controls, & verifications in relation to the EMS.Below is a list of the main SOP’s documenting the control systems for the EMS. Individual departmental SOP’s may reference other relevant SOP’s.

SOP No: SOP Name:EHS SOP’s:

DCC29 API Quality Record Retention Periods and ControlsEHS06 Removing Rainwater from bund surrounding the Oil tankBEHS16 Procedure to carry out Emergency Evacuation of the FacilityBEHS22 Monitoring of Process Wastewater Emissions .BEHS29 Handling, Collection & Disposal of Hazardous chemicals.BEQA25 Control of Deviation and Temporary Change Request (TCR) QMS ProcessBEHS35 Waste Management - Role of EHS JanitorEHS38 Review of the Environmental Effects at AllerganBEHS11 Management of EHS licencesBEHS39 Review of the Environmental, Health & Safety Management Systems at

Allergan Pharmaceuticals IrelandBEHS07 EHS auditingBEHS48 Management of Non-Hazardous WasteBEHS69 Allergan Pharmaceuticals Ireland EHS Communications and Complaints PlanBEHS50 Surface Water Monitoring ProgrammeBEHS51 Off site disposal of Hazardous wasteBEHS59 Control of Calibration of Environmental monitoring equipment at AllerganWE-EHS-P015

Emergency Response Procedure

DEPARTMENTAL S.O.P’s:DCC10 Control of Quality Manual and Environmental DocumentationEPL10 Environmental Control in the Plastics DepartmentEM159 Environmental Control in CompoundingEP31 Environmental Control in the Packaging DepartmentEU31 Environmental Control in the Unit Dose Filling DepartmentES19 Environmental Control in the Steriliser DepartmentEU33 Environmental Control in the Unit Dose Packaging DepartmentBEQA15 Change Control Process at Allergan Pharmaceuticals IrelandBEQA42 Control of Contractors/Subcontractors and Consultants entering the Pharma

and Biologics SitesBEQA43 Vendor selection and qualification process

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Appendix 3 EMS Organization Vice President

&Managing Director

Director Finance

Director Human Resources

Director of Engineering & Technology

Director Site Technical

Services

Director QA

Director Materials

Director Operations

Director Technical

Operations

EHS Supervisor

Health & Safety Officer

EHS Specialist

EHSOfficer

Occ. Nurse/ Trainer

Safety Eng.

Dept Managers

Dept Supervisors

Green Teams

Waste co-ordinator

EHSJanitors

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ALLERGAN PROPRIETARY INFORMATION Document: Version No: Effective Date: Printed by: Printed (PT): Site:

BEHSPOL004GTOPS Westport19 Nov 2013 03:35:46Rowley_Elaine

08 May 2013 03:47:313.0; Most-Recent; Effective; CURRENTDCR-00052146

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Attachment C.3 – Hours of Operation Operation Phase The company operates a three shift system, so that certain parts of the process are in operation 24 hours per day, 7 days per week, however; most departments operate 24 hours per day, 5 days per week. The three daily working shifts are as follows; • 08.00 – 16.30hours • 16.30 – 00.00hours • 00.00 – 08.00hours The following departments operate 24 hours per day, 7 days per week;

• Production • Cleaning/Janitorial • Security • Laboratories (1 shift on Saturdays & Sundays) • Maintenance • Facilities

The following departments operate 24 hours per day, 5 days per week;

• Finance • EHS • DCC • Quality/Compliance • Engineering

It is proposed that the new Biologics II facility will also operate a three shift system as per the existing Biologics I and Pharma facilities. Proposed working hours for the construction phase of the new Biologics II facility are 8.00am-6.00pm on weekdays and 8.00am to 1.00pm on Saturdays. Construction Hours The construction of the Biologics II facility is restricted to the following construction hours over the 2 year timeframe of the construction timeframe:

• 07:00-20:00 hours Monday to Friday • 08:00-16:30 hours Saturday • Sunday and Bank Holiday work restricted unless authorized by Mayo County Council

These restrictions are set out in Condition 7 of the planning permission (P12/451).

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