Request for a Technical Amendment to Industrial Emissions licence Register No. P , held by MSD International GMBH, CRO No.

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1 This report has been cleared for submission by Sean O'Donoghue. Grainne Power, 20/05/ :54 OFFICE OF ENVIRONMENTAL SUSTAINIBILITY To: FROM: C.C: Licensing Programme Memorandum Mr. Dara Lynott, Director Gavin Clabby Frank Clinton DATE: 20 May 2016 RE: Background Request for a Technical Amendment to Industrial Emissions licence Register No. P , held by MSD International GMBH, CRO No MSD international GMBH (hereafter referred to as MSD, or the licensee) has requested a Technical Amendment (TA) to Industrial Emissions Licence Reg No. P , relating to emissions to air. MSD was originally licensed on the 29 December Numerous revised licences (and amendments) have subsequently been issued by the Agency; with the most recent licence (P ) issued on the 12 January The installation is currently licensed under class of the First Schedule of the EPA Act 1992 as amended.the licensable activity is the bulk manufacture of active pharmaceutical ingredients (APIs). The installation is located at Kilsheelan, Ballydine, approximately 15km from Clonmel in South Tipperary and operates on a 24 hour basis. Technical Amendment Request MSD submitted a request to the Agency, on the 21 April 2016, for a TA to its licence. As part of Phase 1 of a boiler replacement project the licensee proposes to install a new twin core boiler emissions stack for a new replacement boiler, which will ultimately replace the existing stack. 2 1 Class 5.16 (The production of pharmaceutical products including intermediates) is the main class of activity at the installation; other classes of activity are; 11.2(e), 11.6, 11.2 (c) and 11.1 which relate to the recovery or disposal of waste. 2 In Phase 1 a new boiler will replace one of three existing boilers at the installation. This new boiler will discharge to air through the proposed new emission point A1-2A. The two remaining old boilers will continue to discharge through the existing licenced emission point A1-1. In Phase 2 (2018) an additional new boiler will replace the two old boilers and will also discharge through A1-2A (rendering A1-1 redundant). Only the Phase 1 alterations are being considered in this assessment; the required licence amendments for Phase 2 will form part of a separate licence alteration request. Page 1 of 5

2 The licensee wishes to have licence P amended to incorporate this new emission point and associated emissions. There are no additional emissions associated with this licence alteration request. Assessment For this TA request, the licensee provided the following information: Details of the requested alteration Supporting information relating to prior contact with the Office of Environmental Enforcement (OEE) Details of the relevant current and proposed schedules in the licence Tabular information on the relevant current and proposed emission points Detailed report on the boiler replacement project Air quality impact assessment report Screening for Appropriate Assessment for proposed boiler and associated stack Confirmation from planning authority that EIA was not required From the above information it can be determined that the alteration request relates to a replacement boiler and associated stack, and that there no additional emissions. Furthermore, it is evident from the proposed schedules that the replacement boiler will result in the reduction of mass emissions from the installation. (Examination of the proposed schedules shows that the sum of the combined volumetric flow limits, from A1-1 and the proposed A1-2A, is less than the volumetric flow limits currently permitted for A1-1, while at the same time, the proposed concentration limits for A1-2A are identical to A1-1.) The air quality impact assessment report submitted by the licensee, incorporated air modelling 3 which demonstrated that the proposed alterations will not result in any off-site exceedances of the relevant air quality standards. A letter from the planning authority (Tipperary County Council) included with the alteration request, confirmed that an environmental impact assessment was not required for the replacement boiler and associated stack. An Appropriate Assessment screening report included with the alteration request, concluded that there is no likely significant effects on any European sites arising from the Phase 1 boiler replacement project. The Agency has also carried an Appropriate Assessment screening of the project, which is detailed below. 3 The modelling approach was based on the adoption of the following worst case scenario : The three boilers (two existing, via A1-1 and one new, via A1-2a) and the remaining licenced combustion emission points, RTO No. 4 and TO No. 3, operating at full load, for 24hrs per day and 365 days per year. According to the licensee, the reality is that all 3 boilers will not operate in unison; the typical operating scenario during Phase 1 will entail only the new replacement boiler (A1-2a) running on full load, and one of the two existing boilers (A1-1) operating on running standby at any one time. Also, in the event that the new boiler is offline for maintenance then the fall-back position is that one of the existing boilers will be the duty boiler with the second boiler in running standby mode. Page 2 of 5

3 Appropriate Assessment The installation is located in the valley floor of the River Suir approximately mid-way between Clonmel and Carrick-on-Suir in South Tipperary. It is bounded on its southern end by the River Suir and on the northern side by the main Limerick to Waterford Road. The activity as a whole was screened for Appropriate Assessment as part of the last review of the licence (P ). The proposed alterations to this licence are limited to air emissions from the activity, which result in the reduction of the overall permitted emissions to air from the installation. Consequently, there are three European sites considered within the zone of influence (within 15 km) of the proposed alterations to the activity: the Lower River Suir SAC (site code: ); the Nire Valley Woodlands SAC (site code: ) and Comeragh Mountains SAC (site code: ). A screening for Appropriate Assessment was undertaken to assess, in view of best scientific knowledge and the conservation objectives of the site, if the activity, individually or in combination with other plans or projects is likely to have a significant effect on any European Site. In this context, particular attention was paid to the European sites on the Lower River Suir (002137), in the Nire Valley woodlands (000608) and the Comeragh Mountains (001952), and the Agency considered, for the reasons set out below, the proposed activity is not directly connected with or necessary to the management of those sites as European Sites and that it can be excluded on the basis of objective scientific information, that the proposed activity, individually or in combination with other plans or projects, will have a significant effect on any European site, and accordingly the Agency determined that an Appropriate Assessment of the proposed activity is not required. This determination is based on the nature and scale of the proposed alterations to the activity. The licence, as altered by this technical amendment, is not expected to result in the activity having an impact on the European sites listed above. The altered licence does not permit any additional discharge of pollutants to the receiving environment. Given the nature of the proposed activity and the potential reduction in emissions from the installation, it has been determined that there will be no resulting significant negative impact on the designated European Sites as a result of the proposed amendments. Recommendation For the reasons outlined above I recommend that the requested licence amendment be approved under Section 96(1)(c) of the EPA Acts as amended, as set out in the attached Recommended Technical Amendment. Signed: Gavin Clabby Page 3 of 5

4 Inspector, OES. Appendix European Site (site code) Distance/ Direction from installation Qualifying interests (* denotes a priority habitat) objectives Atlantic salt meadows (Glauco- Puccinellietalia maritimae) [1330] Mediterranean salt meadows (Juncetalia maritimi) [1410] Water courses of plain to montane levels with the Ranunculion fluitantis and Callitricho-Batrachion vegetation [3260] objectives for Lower River Suir SAC [002137]. Generic Version 4.0 Hydrophilous tall herb fringe communities of plains and of the montane to alpine levels [6430] Old sessile oak woods with Ilex and Blechnum in the British Isles [91A0] Alluvial forests with Alnus glutinosa and Fraxinus excelsior (Alno-Padion, Alnion incanae, Salicion albae)* [91E0] Taxus baccata woods of the British Isles* [91J0] Species: Freshwater Pearl Mussel Margaritifera margaritifera [1029] White-clawed Crayfish Austropotamobius pallipes [1092] Sea Lamprey Petromyzon marinus [1095] Brook Lamprey Lampetra Page 4 of 5

5 planeri [1096] River Lamprey Lampetra fluviatilis [1099] Twaite Shad Alosa fallax fallax [1103] Salmon Salmo salar [1106] Nire Valley Woodlands SAC (Site ) code: 11 km approx. Otter Lutra lutra [1355] Old sessile oak woods with Ilex and Blechnum in the British Isles [91A0] objectives for the Nire Valley Woodlands SAC [000608]. Generic Version 4.0 Comeragh Mountains SAC (001952) 8 km approx. Oligotrophic to mesotrophic standing waters with vegetation of the Littorelletea uniflorae and/or Isoeto-Nanojuncetea [3130] Water courses of plain to montane levels with the Ranunculion fluitantis and Callitricho-Batrachion vegetation [3260] objectives for the Comeragh Mountains SAC [001952]. Generic Version 4.0 Northern Atlantic wet heaths with Erica tetralix [4010] European dry heath [4030] Alpine and Boreal heaths [4060] Calcareous rocky slopes with chasmophytic vegetation [8210] Species: Slender Green Feather-moss Drepanocladus vernicosus [1393] Page 5 of 5