Headquarters P.O. Box 3000 Johnstown Castle Estate County Wexford Ireland. Eli Lilly S.A., trading as Eli Lilly S.A. Irish Branch Location of

Transcription

1 LCENCE REG NO. P HAS BEEN TRANSFERRED. Please note that lcence Reg No. P was transferred to El Llly Knsale Lmted on 30/05/207. For further nformaton on ths please refer to Transfer Notfcaton on the Agency s webste. Headquarters P.O. Box 3000 Johnstown Castle Estate County Wexford reland NDUSTRAL EMSSONS LCENCE Lcence Regster Number: P Company Regster Number: Lcensee: El Llly S.A., tradng as El Llly S.A. rsh Branch Locaton of Dunderrow nstallaton: Knsale County Cork

2 Envronmental Protecton Agency An Ghnomhoreocht um Choomhnr Cornhrhoorl, ENVRONMENTAL PROTECTON AGENCY ACT 992 AS AMENDED NDUSTRAL EMSSONS LCENCE Decson of Agency, under Secton 90(2) of the Envronmental Protecton Agency Act 992 as amended. Reference number n Regster of lcences: POOO9-04 Further to notce dated 7/06/206 the Agency n exercse of the powers conferred on t by the Envronmental Protecton Agency Act 992 as amended, for the reasons herenafter set out, hereby grants a.revsed ndustral Emssons lcence to El Llly S.A., tradng as El Llly S.A. - rsh Branch, Dunderrow, Knsale, County Cork, CRO number , to carry on the followng actvtes: - producton of pharmaceutcal products ncludng ntermedates. - dsposal or recovery of hazardous waste wth a capacty exceedng 0 tonnes per day nvolvng one or more of the followng actvtes: (b) Physco-chemcal treatment (c) Blendng or mxng pror to submsson to any of the other actvtes lsted n paragraph.2 or.3; (e) Solvent reclamaton or regeneraton. - dsposal or recovery of waste n waste ncneraton plants or n waste co-ncneraton plants for hazardous waste wth a capacty exceedng 0 tonnes per day. - temporary storage of hazardous waste, (other than waste referred to n paragraph.5) pendng any of the actvtes referred to n paragraph.2,.3,.5 or.7 wth a total capacty exceedng 50 tonnes, other than temporary storage, pendng collecton, on the ste where the waste s generated at Dunderrow, Knsale, County Cork subject to the condtons as set out. GVEN under the Seal of the Agency ths the?h day of November 20 6 PRESENT when the seal of was afxed hereto: \

3 ~ Communtes ~ Envronmental Protecton Agency Lcence Reg. No. POOO9-04 NTRODUCTON Ths ntroducton s not part of the lcence and does not purport to be a legal nterpretaton of the lcence. El Llly S.A., tradng as El Llly S.A. - rsh Branch s a subsdary of the El Llly nternatonal Corporaton wth ts headquarters n ndana USA. The nstallaton, whch has been n operaton snce 98, s stuated n Dunderrow, approxmately 5 mles from Knsale, County Cork. ' Actve pharmaceutcal ngredents and ntermedates for human and veternary use are manufactured at the plant. The ste s also expandng to become the man centre for the manufacture and supply of actve ngredents for ts new bopharmaceutcal medcnes. El Llly holds EPA consent for the contaned use of Class GMMs (( ) under the GMO (Contaned use) Regulatons, 200 to 200. Ths new botechnology process wll operate n Buldng E42 and Buldng E43. Emssons abatement equpment n operaton on ste ncludes ncnerators, regeneratve thermal oxdsers, carbon absorbers, wastewater treatment plants, solvent recovery and a frewater retenton pond. The revsed lcence provdes for the operaton of two new man ar emsson ponts (Combned Heat and Power Plant and addtonal Boler), two botechnology manufacturng facltes (Buldng E42 and Buldng E43), revson of the exstng ste boundary and operaton of the ncnerator on a dual temperature strategy. The lcence has also been examned n accordance wth the European Envronmental Objectves (Surface Water) Regulatons 2009, as amended and the European Communtes Envronmental Objectves (Groundwater) Regulatons 200, as amended. For the purposes of the ndustral Emssons Drectve (ED) (20 0/75/EU), ths nstallaton falls wthn the scope of Annex as categores 4.5 Producton of pharmaceutcal products ncludng ntermedates (man), 5., 5.2 and 5.5. ' The lcence sets out n detal the condtons under whch El Llly SA., tradng as El Llly S.A. - rsh Branch wll operate and manage ths nstallaton. /',,',/ ntroducton

4 Envronmental Protecton Agenq Lcence Rea. No. POOO9-04 Table of Contents Page No j Glossary of Terms... Decson & Reasons for the Decson... 7 Part Schedule of Actvtes Lcensed... 7 Part Schedule of Actvtes Refused... 8 Part Condtons... 9 ' Condton. Scope... 9 Condton 2. Management of the nstallaton... 9 Condton 3. nfrastructure and Operaton... 2 Condton 4. nterpretaton Condton 5. Emssons... 8 Condton 6. Control and Montorng... 9 Condton 7. Resource Use and Energy Effcency Condton 8. Materals Handlng Condton 9. Accdent Preventon and Emergency Response Condton O. Decommssonng & Resduals Management Condton. Notfcaton, Records and Reports Condton 2. Fnancal Charges and Provsons SCHEDULE A: Lmtatons SCHEDULE B: Emsson Lmts... 29! SCHEDULE C: Control & Montorng SCHEDULE D: Annual Envronmental Report... 44!, t Contents

5 Envronmental Protecton Areno, Lcence Reg. No. POOO9-04 Glossary of Terms All terms n ths lcence should be nterpreted n accordance wth the defntons n the Envronmental Protecton Agency Act 992 as amended Waste Management Act 996 as amended, unless otherwse defned n the secton. Abnormal Operatons, ' Adequate lghtng AER Agreement Any techncal stoppage, dsturbance, or falure of any of the purfcaton devces or the measurement devces, durng whch the concentratons n the dscharges to ar may exceed the prescrbed emsson lmt values. 20 lux measured at ground level. Annual Envronmental Report. Agreement n wrtng. Annually All or part of a perod of twelve consecutve months. App tcat on ' Approprate Faclty Attachment BAT The applcaton by the lcensee for ths lcence. A waste management faclty, duly authorsed under relevant law and techncally sutable. Any reference to Attachments n ths lcence refers to attachments submtted as part of ths lcence applcaton. Best Avalable Technques. ' BAT conclusons BAT reference document Bannually A document contanng the parts of a BAT reference document layng down the conclusons on best avalable technques, ther descrpton, nformaton to assess ther applcablty, the emsson levels assocated wth the best avalable technques, assocated montorng, assocated consumpton levels and, where approprate, relevant ste remedaton measures. A document drawn up by the Commsson of the European Unon n accordance wth Artcle 3 of the ndustral Emssons Drectve, resultng from the exchange of nformaton n accordance wth that Artcle of that Drectve and descrbng, n partcular, appled technques, present emssons and consumpton levels, technques consdered for the determnaton of best avalable technques as well as BAT conclusons and any emergng technques. At approxmately sx - monthly ntervals. Benna ly Once every two years. BOD ' CEN 5 day Bochemcal Oxygen Demand (wthout ntrfcaton suppresson). ComtC EuropCen De Normalsaton - European Commttee for Standardsaton.

6 ~ Doxn Envronmental Protecton APencv Lcence Rep. No. POOO9-04 COD Chemcal Oxygen Demand. Constructon and Demolton Waste Consumpton (n the context of Chapter V ED 200/75/EU) ' Cpm pla nce Pont Complance Value Contanment boom CRO Number Wastes that arse from the constructon, renovaton and demolton actvtes; Chapter 7 of the EWC or as otherwse may be agreed. Shall mean the total nput of organc solvents nto an nstallaton per calendar year, or any other 2 month perod, less than any volatle organc compounds that are recovered for reuse. The pont (locaton, depth) at whch a complance value should be met. Generally t s represented by a borehole or montorng well from whch representatve groundwater samples can be obtaned. The concentraton of a substance and assocated complance regme that, when not exceeded at the complance pont, wll prevent polluton and/or acheve water qualty objectves at the receptor. A boom that can contan spllages and prevent them from enterng drans or watercourses or from further contamnatng watercourses. Company Regster Number. Daly Durng all days of plant operaton and, n the case of emssons, when emssons are takng place; wth at least one measurement on any one day. Any 24 hour perod hrs to 900 hrs. Decbels (A weghted). and furans Means all polychlornated dbenzo-p-doxns and dbenzofurans lsted n Part 2 of Annex V of ED 20 0/75/EU. \ DO Documentaton Dssolved oxygen Any report, record, results, data, drawng, proposal, nterpretaton or other document n wrtten or electronc form whch s requred by ths lcence. 3 Drawng Emsson lmts EMP Any reference to a drawng or drawng number means a drawng or drawng number contaned n the applcaton, unless otherwse specfed n ths lcence. Those lmts, ncludng concentraton lmts and deposton rates, establshed n Schedule B: Emsson Lmts, of ths lcence. Envronmental Management Programme. Envronmental damage EPA As defned n Drectve 2004/35/EC. Envronmental Protecton Agency. f 2

7 European Waste Catalogue (EWC) A harmonsed, non-exhaustve lst of wastes drawn up by the European Commsson and publshed as Commsson Decson 2000/532/EC, as amended by Commsson Decson 20 4/955/EU and any subsequent amendment publshed n the Offcal Journal of the European Communty. Evenng Tme 900hrs to 2300hrs Faclty Fortnghtly Any ste or premses used for the purpose of the recovery or dsposal of waste. A mnmum of 24 tmes per year, at approxmately two week ntervals. Fugtve Emssons (n the context of Chapter V ED 200/75/EU) Gas Ol GC/MS Fugtve emssons shall mean any emssons not n waste gases of volatle organc compounds nto ar, sol and water as well as, solvents contaned n any products, unless otherwse stated n Part 2 of Annex V of the ndustral Emssons Drectve 20 0/75/EU. Gas Ol as defned n Councl Drectve 999/32/EC and meetng the requrements of S.. No. 9 of2008. Gas chromatography/mass spectroscopy. Green Waste Waste wood (excludng tmber), plant matter such as grass cuttngs, and other vegetaton. Groundwater ha Has the meanng assgned to t by Regulaton 3 of the European Communtes Envronmental Objectves (Groundwater) Regulatons 20 0 (S.. No. 9 of 20 O). Hectare. Hazardous Substances Substances or mxtures as defned n Artcle 3 of Regulaton (EC) No 272/2008 of the European Parlament and of the Councl of 6 December 2008 on classfcaton, labellng and packagng of substances and mxtures. Heavy metals Ths term s to be nterpreted as set out n "Parameters of Water Qualty, nterpretaton and Standards" publshed by the Agency n 200. SBN HEPA Flter Hgh Effcency Partculate Ar Flter. HFO Heavy Fuel Ol as defned n Councl Drectve 999/32/EC and meetng the requrements of S.. No. 9 of2008. Hours of operaton CP The hours durng whch the nstallaton s authorsed to be operatonal. nductvely coupled plasma spectroscopy. 3

8 Envronmental Protecton Aaencv Lcence Reg. No. POOOP-04 E ndustral Emssons. ncdent dcneraton Plant ncnerator : Rksdue ndustral Emssons Drectve The followng shall consttute as ncdent for the purposes of ths lcence: () an emergency; () any emsson whch does not comply wth the requrements of ths lcence; () any exceedance of the daly duty capacty of the waste handlng equpment; (v) any trgger level specfed n ths lcence whch s attaned or exceeded; and, (v) any complance value specfed n ths lcence whch s attaned or exceeded; and, (v) any ndcaton that envronmental polluton has, or may have, taken place. As defned n Councl Drectve 20 0/75/EU on ndustral emssons As defned n Councl Drectve 20 0/75/EU on ndustral emssons. Drectve 20 0/75/EU of the European Parlament and of the Councl of 24 November 20 0 on ndustral emssons (ntegrated polluton preventon and control) (Recast). nput (n the context of Chapter V ED 200/75/EU) nstallaton Shall mean the quantty of organc solvents and ther quantty n mxtures used when carryng out an actvty, ncludng solvents recycled nsde and outsde the nstallaton, and whch are counted every tme they are used to carry out the actvty. A statonary techncal unt or plant where the actvty concerned referred to n the Frst Schedule of EPA Act 992 as amended s or wll be carred on, and shall be deemed to nclude any drectly assocated actvty, whch has a techncal connecton wth the actvty and s carred out on the ste of the actvty. j rsh Water 8 : rsh Water, Colvll House, 24/26 Talbot Street, Dubln Kelvn. Klopascals. Ths s the equvalent contnuous sound level. t s a type of average and s used to descrbe a fluctuatng nose n terms of a sngle nose level over the sample perod (T). The Rated Nose Level, equal to the LAeq durng a specfed tme nterval (T), plus specfed adjustments for tonal character and/or mpulsveness of the sound. 4

9 Envronmental Protecton A~encv Lcence Rea. No. POOO9-04 Lcensee Lst El Llly S.A., tradng as El Llly S.A. - rsh Branch, Dunderrow, Knsale. County Cork, CRO Number As lsted n the EC Drectves 2006/ /EC and 80/68/EEC and amendments. Lst As lsted n the EC Drectves 2006/ /EC and 80/68/EEC and amendments. Local Authorty Mantan Mass flow lmt 8 Mass flow threshold Monthly Nght-tme Cork County Councl. Keep n a ft state, ncludng such regular nspecton, servcng, calbraton and repar as may be necessary to perform ts functon adequately. An emsson lmt value expressed as the maxmum mass of a substance that can be emtted per unt tme. A mass flow rate above whch a concentraton lmt apples. A mnmum of 2 tmes per year, at ntervals of approxmately one month hrs. to 0700 hrs. Nose-senstve locaton (NSL) Ol separator ; Organc Solvent PRTR Any dwellng house, hotel or hostel, health buldng, educatonal establshment, place of worshp or entertanment, or any other nstallaton or area of hgh amenty whch for ts proper enjoyment requres the absence of nose at nusance levels. Devce nstalled accordng to the nternatonal Standard.S. EN 858-2:2003 (Separator system for lght lquds, (e.g. ol and petrol) - Part 2: Selecton of normal sze, nstallaton, operaton and mantenance). As defned n Councl Drectve 200/75/EU Pollutant Release and Transfer Regster. Quarterly Relevant Hazardous Substances Sample(s) Santary effluent All or part of a perod of three consecutve months begnnng on the frst day of January, Aprl, July or October. Those substances or mxtures defned wthn Artcle 3 of Regulaton (EC) No 272/2008 on the classfcaton, labellng and packagng of substances and mxtures (CLP Regulaton) whch, as a result of ther hazardousness, moblty, persstence and bodegradablty (as well as other characterstcs), are capable of contamnatng sol or groundwater and are used, produced andor released by the nstallaton. Unless the context of ths lcence ndcates to the contrary, the term samples shall nclude measurements taken by electronc nstruments. Wastewater from nstallaton tolet, washroom and canteen facltes. Sol ~ The top layer of the Earth's crust stuated between the bedrock and the surface. The sol s composed of mneral partcles, organc matter, water, ar 5

10 and lvng organsms. SOP Standard operatng procedure. Specfed emssons Standard method, Storm water The Agency Those emssons lsted n Schedule B: Emsson Lmts, of ths lcence. A Natonal, European or nternatonally recognsed procedure (e.g..s. EN, EO, CEN, BS or equvalent); or an n-house documented procedure based on the above references; a procedure as detaled n the current edton of Standard Methods for the Examnaton of Water and Wastewater (prepared and publshed jontly by A.P.H.A., A.W.W.A. & W.E.F.), Amercan Publc Health Assocaton, 0 5 Ffteenth Street, N.W., Washngton DC 20005, USA; or an alternatve method as may be agreed by the Agency. Ran water run-off from roof and non-process areas. Envronmental Protecton Agency. TOC / Trade effluent Total organc carbon. Trade effluent has the meanng gven n the Water Servces Act, Trgger level Volatle Organc Compound (VOC) Waste Water Servces Authorty Weekly WWTP A parameter value, the achevement or exceedance of whch requres certan actons to be taken by the lcensee. Shall mean any organc compound as well as the fracton of creosote, havng at 293,5K a vapour pressure of 0,Ol kpa or more, or havng a correspondng volatlty under the partcular condtons of use. Any substance or object whch the holder dscards or ntends or s requred to dscard. Cork County Councl (Southern Dvson). Durng all weeks of plant operaton and, n the case of emssons, when emssons are takng place; wth at least one measurement n any one week. Waste water treatment plant. 6

11 Envronmental Protecton Aaencv Lcence Rea. No. POOO9-04 Decson & Reasons for the Decson The Envronmental Protecton Agency s satsfed, on the bass of the nformaton avalable, that subject to complance wth the condtons of ths lcence, any emssons from the actvty wll comply wth and wll not contravene any of the requrements of Secton 83(5) of the Envronmental Protecton Agency Act 992 as amended. n reachng ths decson the Envronmental Protecton Agency has consdered the documentaton relatng to the current lcence, Regster Number: POOO9-03, and the revew applcaton Regster Number: POOO9-04. Ths ncludes supportng documentaton receved from the applcant, a submsson receved from a thrd party, the nspector's Report dated 25 May 206, the Proposed Determnaton dated 7 June 206, the objecton receved from the Applcant, the Techncal Commttee Report dated November 206 on the objecton to the Proposed Determnaton and has carred out an Envronmental mpact Assessment (EA) report and an Approprate Assessment Screenng of the lkely sgnfcant effects of the actvtes on European Stes. t s consdered that the nspector's Report and the Techncal Commttee Report contan far and reasonable assessment of the lkely sgnfcant effects of the actvtes on the envronment, and adequately and accurately dentfes, descrbes and assesses those effects. The assessment as reported s adopted as the assessment of the Agency. Havng regard to ths assessment, t s consdered that the actvtes, f managed, operated and controlled n accordance wth the lcence wll not result n the contraventon of any relevant envronmental qualty standards or cause envronmental polluton.. A screenng for Approprate Assessment was undertaken to assess, n vew of best scentfc knowledge and the conservaton objectves of the ste, f the actvty, ndvdually or n combnaton wth other qlans or projects, s lkely to have a sgnfcant effect on any European Stes. n ths context, partcular attenton was pad to the European stes at Soveregn slands SPA (004 24), Old Head of Knsale SPA (00402 ), Courtmacsherry Bay SPA (0042 9), and Courtmacsherry Estuary SAC (00 230). The actvtes are not drectly connected wth or necessary to the management of any European Ste and the Agency consdered, for the reasons set out below, that t can be excluded, on the bass of objectve nformaton, that the actvtes, ndvdually or n combnaton wth other plans or projects wll have a sgnfcant effect on a European ste, and accordngly determned that an Approprate Assessment of the actvtes was not requred. Ths determnaton s based on the followng reasons: - ', -.', :.,, ' The nstallaton s not located wthn any European ste. Ar dsperson modellng conducted demonstrates that emssons from the actvty wll not cause breaches of relevant ar qualty standards or gudelnes beyond the ste boundary and wll have a neglgble mpact on any SACSPA. Schedule B: Emsson Lmts, of ths lcence, specfes lmt values for emssons to ar whch wll not adversely affect protected speces and habtats. t has been determned that the two onste WWTP's have the capacty to suffcently treat the effluent dscharges from the actvty, whch ultmately dscharges va SW to an outfall n Knsale Harbour, whch hydrologcally s approxmately 3.8km west of the Soveregn slands SPA (ste code: 00424). The lcence requres the lcensee to meet emsson lmt values set n Schedule B: Emsson Lmts, of ths lcence, to ensure dscharges wll not negatvely mpact water qualty and ensure the contnued protecton of water dependent speces. The tropc status of Knsale Harbour s unpolluted (204). Wth respect to water qualty, the process effluent was assessed n terms of BAT for the sector; Surface waters regulatons, Groundwater Regulatons and Chapter V & V of the ED. Ths wll contrbute to the protecton of ths waterbody. There s no drect emsson to groundwater. There are specfc precautonary nfrastructural and procedural measures n place at the nstallaton to prevent sgnfcant mpacts occurrng due to chemcal splls or fre. As the nearest SPA s 3.8km from the outfall and the nearest SAC s 8.6km from the nstallaton, t s consdered that nose wll not mpact on the nose senstve qualfyng nterests.

12 Envronmental Protecton Anencv Lcence Ren. No. P Part Schedule of Actvtes Lcensed n pursuance of the powers conferred on t by the Envronmental Protecton Agency Act 992 as amended, the Agency hereby grants ths revsed ndustral Emssons lcence to: El Llly S.A., tradng as El Llly S.A. - rsh Branch, Dunderrow, Knsale, County Cork, and CRO Number Under Secton 90(2) of the sad Act to carry on the followng actvtes: - producton of pharmaceutcal products ncludng ntermedates. - dsposal or recovery of hazardous waste wth a capacty exceedng 0 tonnes per day nvolvng one or more of the followng actvtes: (b) Physco-chemcal treatment (c) Blendng or mxng pror to submsson to any of the other actvtes lsted n paragraph.2 or.3; (e) Solvent reclamaton or regeneraton., - dsposal or recovery of waste n waste ncneraton plants or n waste co-ncneraton plants for hazardous waste wth a capacty exceedng O tonnes per day. - temporary storage of hazardous waste, (other than waste referred to n paragraph.5) pendng any of the actvtes referred to n paragraph.2,.3,.5 or.7 wth a total capacty exceedng 50 tonnes, other than temporary storage, pendng collecton, on the ste where the waste s generated. at Dunderrow, Knsale, County Cork, subject to the followng twelve Condtons, wth the reasons therefor and assocated schedules attached thereto. Part Schedule of Actvtes Refused None of the proposed actvtes as set out n the lcence applcaton trave been refused.? 8

13 Condton. Scope Part Condtons. 8.2 \'.3 / ndustral Emssons actvtes at ths nstallaton shall be restrcted to those lsted and descrbed n Part Schedule of Actvtes Lcensed, and shall be as set out n the lcence applcaton or as modfed under Condton.4 of ths lcence and subject to the condtons of ths lcence. Actvtes at ths nstallaton shall be lmted as set out n Schedule A: Lmtatons, of ths lcence. For the purposes of ths lcence, the nstallaton authorsed by ths lcence s the area of land outlned n red on Drawng No. EOY - A , revson 04, enttled El Llly Ste Boundary & Surroundng Lands Dunderrow Knsale of the applcaton for ths revsed lcence. Any reference n ths lcence to "nstallaton" shall mean the area thus outlned red. The lcensed actvtes shall be carred on only wthn the area outlned. No alteraton to, or reconstructon n respect of, the actvty, or any part thereof, that would, or s lkely to, result n. () a materal change or ncrease n: the nature or quantty of any emsson; the abatemenutreatment or recovery systems; the range of processes to be carred out; the fuels, raw materals, ntermedates, products or wastes generated, or () any changes n:. ste management, nfrastructure or control wth adverse envronmental sgnfcance; shall be carred out or commenced wthout pror notce to, and wthout the agreement of, the Agency. The nstallaton shall be controlled, operated and mantaned, and emssons shall take place as set out n the lcence. All programmes requred to be carred out under the terms of ths lcence become part of ths lcence. Ths lcence s for the purpose of ndustral Emssons lcensng under the EPA Act 992 as amended only and nothng n ths lcence shall be construed as negatng the lcensee's statutory oblgatons or requrements under any other enactments or regulatons. Ths lcence shall have effect n leu of the lcence granted on 27 July 2005 (Regster No. POOO9-03). Reason: To claryy the scope of ths lcence. Condton 2. Management of the nstallaton 2. nstallaton Management 2.. The lcensee shall employ a sutably qualfed and experenced nstallaton manager who shall be desgnated as the person n charge. The nstallaton manager or a nomnated, sutably qualfed and experenced deputy shall be present on the nstallaton at all tmes durng ts operaton or as otherwse requred by the Agency. 9

14 Envronmental Protecton Agency Lcence Reg No. POOO The lcensee shall ensure that personnel performng specfcally assgned tasks shall be qualfed on the bass of approprate educaton, tranng and experence as requred and shall be aware of the requrements of ths lcence. 2.2 Envronmental Management System (EMS) ' / 2.2. The lcensee shall mantan and mplement an Envronmental Management System (EMS), whch shall ncorporate energy effcency management. The EMS shall be revewed by senor management for sutablty, adequacy and effectveness and updated on an annual bass The EMS shall nclude, as a mnmum, the followng elements: Commtment of the management, ncludng senor management An envronmental polcy defned for the nstallaton that ncludes the contnuous mprovement for the nstallaton by the management Management and Reportng Structure and responsblty The necessary procedures, objectves and targets, n conjuncton wth fnancal plannng and nvestment Procedures that ensure employee nvolvement n ensurng complance wth envronmental legslaton A procedure for checkng performance by sectoral benchmarkng on a regular bass ncludng energy effcency Schedule of Envronmental Objectves and Targets., '!, :j! l \! x ' The lcensee shall mantan and mplement a Schedule of Envronmental Objectves and Targets. The schedule shall, as a mnmum, provde for a revew of all operatons and processes, ncludng an evaluaton of practcable optons, for energy and resource effcency, the use of cleaner technology, cleaner producton, good housekeepng practces (to nclude the removal of algae from the contanment pond) and the preventon, reducton and mnmsaton of waste and shall nclude waste reducton targets. The schedule shall nclude tme frames for the achevement of set targets and shall address a fve-year perod as a mnmum. The schedule shall be revewed annually and amendments thereto notfed to the Agency for agreement as part of the Annual Envronmental Report (AER). n partcular the Schedule shall nclude an evaluaton of practcable optons and proposals for the reducton of NOx emssons to ar Envronmental Management Programme (EMP) The lcensee shall mantan and mplement an EMP, ncludng a tme schedule, for achevng the Envronmental Objectves and Targets prepared under Condton The EMP shall nclude:. desgnaton of responsblty for targets; the means by whch they may be acheved; the tme wthn whch they may be acheved. The EMP shall be revewed annually and amendments thereto notfed to the Agency for agreement as part of the Annual Envronmental Report (AER). A report on the programme, ncludng the success n meetng agreed targets, shall be prepared and submtted to the Agency as part of the AER. Such reports shall be retaned on-ste for a perod of not less than seven years and shall be avalable for nspecton by authorsed persons of the Agency Documentaton () The lcensee shall mantan and mplement an envronmental management documentaton system. O

15 ! ' Envronmental Protecton Apency -. Lcence Reg. No. POOO9-04 J ' () The lcensee shall ssue a copy of ths lcence to all relevant personnel whose dutes relate to any condton of ths lcence Correctve and Preventatve Acton () () () The lcensee shall establsh mantan and mplement procedures to ensure that correctve and preventatve acton s taken should the specfed requrements of ths lcence not be fulflled. The responsblty and authorty for persons ntatng further nvestgaton and correctve and preventatve acton n the event of a reported non-conformty wth ths lcence shall be defned. nternal Audts Where a breach of one or more of the condtons of ths lcence occurs, the lcensee shall wthout delay take measures to restore complance wth the condtons of ths lcence n the shortest possble tme and ntate any feasble preventatve actons to prevent recurrence of the breach. All correctve and preventatve actons shall be documented The lcensee shall mantan and mplement a programme for ndependent nternal audts of the EMS. Such audts shall be carred out at least once every three years. The audt programme shall determne whether or not the EMS s beng mplemented and mantaned properly, and n accordance wth the requrements of the lcence. Audt reports and records of the resultant correctve and preventatve actons shall be mantaned as part of the EMS n accordance wth condton Awareness, Tranng and Competence The lcensee shall mantan and mplement procedures for dentfyng tranng needs, and for provdng approprate tranng, for all personnel whose work can have a sgnfcant effect upon the envronment to ensure awareness and competence n ther work area. Approprate records of tranng shall be mantaned Communcatons Programme The lcensee shall mantan and mplement a Publc Awareness and Communcatons Programme to ensure that members of the publc can obtan nformaton at the nstallaton, at all reasonable tmes, concernng the envronmental performance of the nstallaton Mantenance Programme The lcensee shall mantan and mplement a programme for mantenance of all plant and equpment based on the nstructons ssued by the manufacturer/suppler or nstaller of the equpment. Approprate record keepng and dagnostc testng shall support ths mantenance programme. The lcensee shall clearly allocate responsblty for the plannng, management and executon of all aspects of ths programme to approprate personnel (see Condton 2. above). The mantenance programme shall use approprate technques and measures to ensure the optmsaton of energy effcency n plant and equpment Effcent Process Control The lcensee shall mantan and mplement a programme to ensure there s adequate control of processes under all modes of operaton. The programme shall dentfy the key ndcator parameters for process control performance, as well as dentfyng methods for measurng and controllng these parameters. Abnormal process operatng condtons shall be documented, and analysed to dentfy any necessary correctve acton.

16 Envronmental Protecton Agencv Lcence Reg. No. POOO9-04 Reason: To make provson for management of he actvty on aplanned bass havng regard to the desrablty of on-gong assessment, recordng and reportng of matters affectng the envronment, Condton 3. nfrastructure and Operaton The lcensee shall establsh and mantan, for each component of the nstallaton, all nfrastructure referred to n ths lcence n advance of the commencement of the lcensed actvtes n that component, or as requred by the condtons of ths lcence. nfrastructure specfed n the applcaton that relates to the envronmental performance of the nstallaton and s not specfed n the lcence, shall be nstalled n accordance wth the schedule submtted n the applcaton. The lcensee shall have regard to the followng when choosng andor desgnng any new plant/nfrastructure: () Energy effcency, and () The envronmental mpact of eventual decommssonng, nstallaton Notce Board (9 The lcensee shall mantan an nstallaton Notce Board on the nstallaton so that t s legble to persons outsde the man entrance to the nstallaton. The mnmum dmensons of the board shall be 200 mm by 750 mm. The notce board shall be mantaned thereafter. () The board shall clearly show: a) the name and telephone number of the nstallaton; b) the normal hours of operaton; c) the name of the lcence holder; d) an emergency out of hours contact telephone number; e) the lcence reference number; and 0 where envronmental nformaton relatng to the nstallaton can be obtaned. The lcensee shall nstall on all emsson ponts such samplng ponts or equpment, ncludng any data-loggng or other electronc communcaton equpment, as may be requred by the Agency. All such equpment shall be consstent wth the safe operaton of all samplng and montorng systems. n the case of composte samplng of aqueous emssons from the operaton of the nstallaton, a separate composte sample or homogeneous sub-sample (of suffcent volume as advsed) shall be refrgerated mmedately after collecton and retaned as requred for EPA use. 3.6 The lcensee shall clearly label and provde safe and permanent access to all on-ste samplng and montorng ponts and to off-ste ponts as requred by the Agency. The requrement wth regard to off-ste ponts s subject to the pror agreement of the landowner(s) concerned. 3.7 Tank, Contaner and Drum Storage Areas 3.7. All tank, contaner and drum storage areas shall be rendered mpervous to the materals stored theren. Bunds shall be desgned n accordance wth Agency gudelnes 'Storage and Transfer of Materals for Scheduled Actvtes' (2004) All tank and drum storage areas shall, as a mnmum, be bunded, ether locally or remotely, to a volume not less than the greater of the followng: () 0% of the capacty of the largest tank or drum wthn the bunded area; or 2

17 Envronmental Protecton Aaencv Lcence Rea. No. POOO9-04 \ 3.s () 25% of the total volume of substance that could be stored wthn the bunded area All dranage from bunded areas shall be treated as contamnated unless t can be demonstrated to be otherwse. All dranage from bunded areas shall be dverted for collecton and safe dsposal, unless t can be deemed uncontamnated and does not exceed the trgger levels set for storm water emssons under 6.2. All nlets, outlets, vent ppes, valves and gauges must be wthn the bunded area. All tanks, contaners and drums shall be labelled to clearly ndcate ther contents. The lcensee shall apply a leak detecton system n accordance wth BAT to all storage tanks, contaner and drum storage areas that contan lqud materal other than water. The lcensee shall have n storage an adequate supply of contanment booms and/or sutable absorbent materal to contan and absorb any spllage at the nstallaton. Once used, the absorbent materal shall be dsposed of at an approprate faclty. Fre-water Retenton 3.9. The lcensee shall revew the frewater retenton rsk assessment to take nto account the mpact of any changes on the ste, ncludng the nstallaton of Buldng E42, Buldng E43, CHP plant and the boler The lcensee shall prepare a sutable frewater management programme for the retenton of frewater, to nclude approprate measures to be taken, takng nto account the fndngs of the rsk assessment revew. The lcensee shall submt a report on the rsk assessment revew, ncludng all fndngs and recommendatons, and the frewater management programme to the Agency wthn three months of the date of grant of ths lcence. The frewater management programme shall be fully mplemented wthn sx months from the date of notfcaton by the Agency. n the event of a fre or a spllage to storm water, the ste storm water shall be automatcally dverted to the frewater contanment pond. The storage capacty shall be adequate to ensure that such waters can be tested before dscharge where necessary. Frewater retenton shall be n accordance wth any gudelnes ssued by the Agency ' The lcensee shall have regard to the Envronmental Protecton Agency Draft Gudance Note to lndustry on the Requrements for Fre-Water Retenton Facltes when mplementng Condtons 3.9. and above. All pump sumps, storage tanks, lagoons or other treatment plant chambers from whch spllage of envronmentally sgnfcant materals mght occur n such quanttes as are lkely to breach local or remote contanment or separators, shall be ftted wth hgh lqud level alarms (or ol detectors as approprate). The provson of a catchment system to collect any leaks from flanges and valves of all overground ppes used to transport materal other than water shall be examned. Ths shall be ncorporated nto a Schedule of Envronmental Objectves and Targets set out n Condton 2. of ths lcence for the reducton n fugtve emssons. All wellheads shall be adequately protected to prevent contamnaton or physcal damage. The lcensee shall mantan n a promnent locaton on the ste a wnd sock, or other wnd drecton ndcator, whch shall be vsble from the publc roadway outsde the ste. The lcensee shall operate a weather montorng staton on the ste, a wnd sock, or other wnd drecton ndcator, whch shall be vsble from the publc roadway outsde the ste. 3

18 Envronmental Protecton Aaencv Lcence Rea. No. POOO Natural gas shall be used n the bolers and CHP plant on ste. n the event of an nterrupton to the supply of natural gas, an alternatve fuel such as gas ol may be used wth the pror wrtten agreement of the Agency. ncnerator Plant Operaton 3.6. The nomnal capacty of the plant shall not exceed SMW, 75m3/day waste solvent for the KEU ncnerator and shall not exceed () 7.3MW and () 68m3/day waste solvent for the Thermall ncnerator The calorfc values of the waste nput nto the ncnerators shall be a mnmum of 0. MJkg and a maxmum of 50 MJkg. ncnerators shall be operated n order to acheve a level of ncneraton such that the TOC content of slag and bottom ashes s less than 3% or ther loss on gnton s less than 5% of the dry weght of the materal. Even under the most unfavourable of condtons, the ncnerators shall be operated n such a way that, after the last njecton of combuston ar, the gas resultng from the process s rased, n a controlled and homogeneous fashon, for a duraton of two seconds to a temperature of 850 C as measured near the nner wall or at another representatve pont of the combuston chamber as authorsed by the Agency. f hazardous wastes or waste wth a content of > % of halogenated organc substances, expressed as chlorne, are ncnerated the temperature has to be rased to OOOC for at least two seconds. Waste lquds shall be charged nto the ncnerators only when these operatng condtons are beng compled wth and when the contnuous montorng shows that the emsson lmt values are not beng exceeded. Each ncnerator plant shall be equpped wth at least one auxlary burner. The burner must be swtched on automatcally when the temperature of the combuston gases after the last njecton of combuston ar falls below 850 C or 00 C as approprate. The auxlary burner shall also be used durng plant start-up and shutdown operatons n order to ensure the temperature of 850 C or 00 C as approprate s mantaned at all tmes durng the operatons and as long as unburned waste s n the combuston chamber. Durng start up or shut-down or when the temperature of the combuston gas falls below 850 C or l00"c as approprate, the auxlary burners shall not be fed wth fuels whch may cause hgher emssons than those resultng from the burnng of gas ol, as defned n Councl Drectve 999/32/EC, relatng to a reducton n the sulphur content of certan lqud fuels, lquefed gas or natural gas. The ncnerators shall have and operate an automatc system to prevent waste feed: () At start-up, untl the temperature of 850 C or 00 C as approprate has been reached; () () Whenever the temperature of 850 C or OOT as approprate s not mantaned; Whenever the contnuous measurements show that any emsson lmt value s exceeded due to dsturbances or falures of the purfcaton devces; 3.7 (v) Whenever stoppages, dsturbances, or falure of the purfcaton devces or the measurement devces may result n the exceedance of the emssons lmt values. Abnormal Operaton (ncneraton) 3.7. n the case of abnormal operatng condtons, the ncnerators shall be shut-down as soon as practcable n a manner consstent wth safety and the protecton of the envronment. 4

19 3.7.2 The lcensee shall under no crcumstances contnue to ncnerate waste for a perod of more than four hours unnterrupted where emsson lmt values specfed n Schedule B. Emssons to Ar, of ths lcence, are exceeded; and The cumulatve duraton of abnormal operatons over one calendar year shall be less than 60 hours; and The total dust content of the emsson from each of the ncnerator stacks shall under no crcumstances exceed 50 mg/m3 (expressed as a half-hourly average); and; The emsson lmt values specfed n Schedule B. : Emsson to Ar, of ths lcence, for CO and TOC shall not be exceeded. 3.8 The Regeneratve Thermal Oxdsers (dutyktandby) emsson pont No. A2- shall not combust waste streams wth a halogenated organc substances content greater than %, expressed as chlorne. Reason: To provde for approprate operaton of the nstallaton to ensure protecton of the, envronment. t Condton 4. ' nterpretaton ;, 4. Emsson lmt values for emssons to atmosphere from the waste ncneraton plants n ths lcence shall be nterpreted n the followng way: 4.. Contnuous Montorng 4... The half-hourly average values and the O-mnute averages shall be determned wthn the effectve operatng tme (excludng the start-up and shut-off perods f no waste s beng ncnerated) from the measured values after havng subtracted the value of the confdence nterval specfed at below. The daly average values shall be determned from those valdated average values At the daly emsson lmt value level, the values of the 95% confdence ntervals of a sngle measured result shall not exceed the followng percentages of the emsson lmt values: Carbon monoxde: Sulphur doxde: Ntrogen doxde: Total dust: Total organc carbon: Hydrogen chlorde: Hydrogen fluorde: Ammona 0 Yo 20 Yo 20 Yo 30 Yo 30 Yo 40 Yo 40 % 40 Yo To obtan a vald daly average value no more than fve half hourly average values n any day shall be dscarded due to malfuncton or mantenance of the contnuous measurement system. No more than ten daly average values per year shall be dscarded due to malfuncton or mantenance of the contnuous measurement system Non-Contnuous Montorng For perodc measurements, complance shall be determned from the measured value after havng subtracted the uncertanty error for the selected method of samplng and analyss for each relevant pollutant.? 5

20 Envronmental Protecton Aaencv Lcence Rea. No. POOO For any parameter where, due to samplng/analytcal lmtatons, a 30 mnute samplng perod s napproprate, a sutable perod between 30 mnutes and 8 hours should be employed and the value obtaned theren shall not exceed the emsson lmt value For all other parameters, no 30 mnute mean value shall exceed the emsson lmt value. For flow, no hourly or daly mean value shall exceed the emsson lmt value. Emsson lmt values for emssons to atmosphere for all other emsson ponts n ths lcence shall be nterpreted n the followng way: 4.2. Contnuous Montorng: (0 No 24 hour mean value shall exceed the emsson lmt value. () For TOC (as C) concentraton lmts, none of the arthmetc averages of all vald readngs taken durng any 24 -hour perod of operaton of an nstallaton or actvty, except start up and shut down operatons and mantenance of equpment, shall exceed the emsson lmt value. () 97% of all 30 mnute mean values taken contnuously over an annual perod shall not exceed.2 tmes the emsson lmt value. (v) (V No 30 mnute mean value shall exceed twce the emsson lmt value. For TOC (as C) concentraton lmts, none of the hourly averages shall exceed the emsson lmt value by more than a factor of For Non-Contnuous Montorng ;.,., For any parameter where, due to samplng/analytcal lmtatons, a 30 mnute sample s napproprate, a sutable samplng perod should be employed and the value obtaned theren shall not exceed the emsson lmt value. For flow, no hourly or daly mean value, calculated on the bass of approprate spot readngs, shall exceed the relevant lmt value. For TOC (as C) concentraton lmts, the emsson lmt value shall be consdered to be compled wth f (n one montorng exercse): a) The average of all readngs does not exceed the emsson lmt value and; b) None of the hourly values exceed the emsson lmt value by more than a factor of.5. At least three consecutve readngs shall be obtaned n each montorng exercse. For all other parameters, no 30 mnute mean value shall exceed the emsson lmt value. Mass flow thresholds refer to a rate of dscharge expressed n unts of kg/h, above whch the concentraton emsson lmt value apples. Mass flow threshold rates shall be determned on the bass of a sngle 30 mnute measurement (.e. the concentraton determned as a 30 mnute average shall be multpled by an approprate measurement of flow and the result shall be expressed n unts of kgh). Mass flow lmts shall be calculated on the bass of the concentraton, determned as an average over the specfed perod, multpled by an approprate measurement of flow. No value, so determned, shall exceed the mass flow lmt value.

21 Envronmental Protecton Agencv Lcence Rea. No. POOO ' The concentraton and volume flow lmts for emssons to atmosphere specfed n ths lcence shall be acheved wthout the ntroducton of dluton ar and shall be based on gas volumes under standard condtons of : n the case of non-combuston gases: Temperature 273K, Pressure 0.3 kpa (no correcton for oxygen or water content). n the case of combuston gases (other than from waste ncneraton or from the Thermal Oxdser): Temperature 273K, Pressure 0.3 kpa, dry gas; 3% oxygen for lqud and gas fuels; 6% oxygen for sold fuels, 5% oxygen for CHP Plant. n the case of combuston gases from waste ncneraton: Temperature 273 K; pressure 0.3 kpa; % oxygen; dry gas. n the case of combuston gases from the Thermal Oxdsers: Temperature 273 K; pressure 0.3 kpa; 20 % oxygen; dry gas.. Emsson lmt values for emssons to waters n ths lcence shall be nterpreted n the followng way: 4.4. Contnuous Montorng () No flow value shall exceed the specfc lmt. () No ph value shall devate from the specfed range. () No temperature value shall exceed the lmt value Composte Samplng () No ph value shall devate from the specfed range. () For parameters other than ph and flow, eght out of ten consecutve composte results, based on flow proportonal composte samplng, shall not exceed the emsson lmt value. No ndvdual results smlarly calculated shall exceed.2 tmes the emsson lmt value Dscrete Samplng For parameters other than ph and temperature, no grab sample value shall exceed.2 tmes the emsson lmt value. For waste water from the cleanng of exhaust gases from ncneraton actvtes: 4.5. For total suspended solds, none of the values shall exceed the emsson lmt values set out n Column B of Schedule B.2: Emssons to Water, Emsson Pont Reference No: SW2, of ths lcence, and 95% of the values shall not exceed the emsson lmt values set out n Column A of Schedule B.2: Emssons to Water, Emsson Pont Reference No: SW2, of ths lcence For parameters other than total suspended solds the measured value shall not exceed the emsson lmt value For heavy metals, no more than one measurement per year shall exceed the emsson lmt value. f more than twenty samples per year are taken, 95% of all measurements shall not exceed the emsson lmt value For doxns and furans, no measured value shall exceed the emsson lmt value. Where the ablty to measure a parameter s affected by mxng before emsson, then, wth agreement from the Agency, the parameter may be assessed before mxng takes place. Nose Nose from the nstallaton shall not gve rse to sound pressure levels (LAeq, T) measured at NSLs n the vcnty of the nstallaton whch exceed the lmt value(s).,

22 Envronmental Protecton Agency Lcence Reg. No. POOO9-04? Reason: To clarfv tlre nterpretaton of lmt values frrced under the lcence. Condton 5. Emssons 5. 5.F fl /' No specfed emsson from the nstallaton shall exceed the emsson lmt values set out n Schedule B: Emsson Lmts, of ths lcence, subject to the provsons of Condton 3.7. There shall be no other emssons of envronmental sgnfcance. No emssons, ncludng odours, from the actvtes carred on at the ste shall result n an mparment of, or an nterference wth amentes or the envronment beyond the nstallaton boundary or any other legtmate uses of the envronment beyond the nstallaton boundary. No substance shall be dscharged n a manner, or at a concentraton, that, followng ntal dluton, causes tantng of fsh or shellfsh. Dscharges from the nstallaton shall not artfcally ncrease the ambent temperature of the recevng water by more than S0C outsde the mxng zone (.e. from a dstance of 250m from the outfall). Any substance or mxtures used n manufacturng of pharmaceutcal products at the nstallaton, whch, because of ther content of VOCs classfed as carcnogens, mutagens, or toxc to reproducton under Regulaton (EC) No 272/2008, are assgned or need to carry the hazard statements H340, H350, H350, H360D or H360F, (or the rsk phrases R45, R46, R49, R60 or R6) shall be replaced, as far as possble by less harmful substances or mxtures wthn the shortest possble tme. Measures for replacement of such substances or mxtures, and the tmeframe for replacement, shall be ncorporated nto the Schedule of Envronmental Objectves and Targets under Condton Any substance or mxtures used n manufacturng of pharmaceutcal products at the nstallaton, whch, because of ther content of VOCs classfed as carcnogens, mutagens, or toxc to reproducton under Regulaton (EC) No 272/2008, are assgned or need to carry the hazard statements H340, H350, H350, H360D or H360F, (or the rsk phrases R45, R46, R49, R60 or R6) are emtted at levels above the stated mass flow threshold, they must comply wth the emsson lmt values (mass sum of the ndvdual compounds) n Schedule B.: Emssons to Ar, of ths lcence untl they have been replaced by less harmful substances n accordance wth Condton 5.5. Fugtve emsson shall not exceed 5% of the total solvent nput, where solvent consumpton s greater than 50 tonnes per calendar year. Planned/Future Emsson Ponts Planned future emsson ponts A-2, A2-3, A2-4 and A2-5 are lcensed, but shall not be nstalled, commssoned or operated untl: () () The lcensee demonstrates that they are n recept of plannng permsson, or a statement from the relevant authorty that they are exempt from the need for plannng permsson and, followng ths, Ther locatons, where relevant, have been specfed by way of a techncal amendment to ths lcence. Reason: To provde for tlre protecton of the envronment by way of control and lmtaton of emssons. 8