- - F( Signed: I%!& Date: 03/12/2015 L I RESOURCE USE ~ I 1 RE: . _ I 03 DECEMBER 2015.

Transcription

1 . 1 _- - -, - Ths document has been cleared for submsson to the Drector bv the Senor n e or: Sean O Donoghue F( Sgned: %!& Date: 03/12/2015 L RESOURCE USE ~ RE: 03 DECEMBER Applcaton for th e revew of an ndustral Emssons Lcence from a AbbVe reland NL B.V., Lcence Regster PO Class of actvty (Frst Schedule of EPA Acts 1992 as,amended):. : Category, of Actvty under ndustral Emssons Drectve: (2010/75/EC) : Ttle of BREF Document (man): CRO Number: 1 { * Lcence applcaton receved: 1 Notces under Regulaton 10(2)( b)() ssued: nformaton under Regulaton 10(2)( b)() receved : Unsolcted Addtonal nformaton submtted by applcant: SubmsGons receved: Ste notce nspected: Ste vs$: The producton of pharmaceutcal products ncludng ntermedates! Producton of pharmaceutcal produrn ncludng ntermedates Reference Document on Best Avalable Technques for the Manufacture of Organc Fne Chemcals September November November 2015.: 02 December _ HSE, 23 November September November

2 1. Background. - - Abbve'reland NL B.V: d(herea$er Abbve or the lcensee) s a subsdary of Abbve nc. North Chcago, llnos, USA: ts nstallaton at Slgo was orgnally lcensed by the Agency n December 2002 (Lcence No , as Abbott reland) for the manufacture of a number of actve pharmaceutcal ngredents (AP's) for medcal applcatons. The lcensee requested a revew of PO n 2005 to take account of the proposed ntroducton of new processes on ste. The revsed lcence (PO ssued to Abbott reland) provded for the ntroducton of a chlornated solvent onste (dchloromethane) and addtonal abatement equpment (cryogenc condenser) for the treatment of gaseous exhaust streams contanng dchloromethane. The revsed lcence also provded for the expanson of the producton, laboratory and storage areas, as well provdng for the ncrease n volumetrc flows through the exstng thermal oxdser (TO) and the volumetrc flow through the process scrubber. Lcence Reg. No. PO also took nto account changes n legslatve requrements under the POE Act, Ths lcence was amended on a number of occasons, prncpally for the purposes of changes to ar emssons abatement, dscharges to sewer and legslatve requrements for certan hazardous substances, as well beng amended for the purposes of complance wth the ndustral Emssons Drectve. More recently, on the 23 July ths year, the lcence was transferred from Abbott reland to AbbVe. On the 17 September ths year Abbve appled for a second revew of ts lcence. Ths applcaton for a revew (lcence Reg. No. PO643-03) s prncpally to allow for the manufacture of a new oncology drug at the nstallaton. The new drug manufacturng process wll nclude the ncreased use of dchloromethane (DCM). The lcence revew s ntended to facltate the abatement of chlornated solvents by a new TO, whch s currently beng commssoned under an approved test programme. 2. nstallaton The nstallaton s located n the town lands of Ballytvnan and Rathbraughan on the outskrts of Slgo town, County Slgo and operates 24 hours a day, seven days a week. Currently there are approxmately 195 employees., 3. Process Descrpton -. The plant operates n batch mode usng standard reacl,m, extrac on, purfcaton, crystallsaton, solaton and dryng equpment. The nstallaton ncludes. a Drug Product Buldng whch contans blendng, mllng and tablet compresson equpment. A thermal oxdser s used at the nstallaton for the abatement of the current stream of non-chlornated solvents used n the current lcensable actvty. The lcensee s proposng the use of a new drect-fred TO to abate both chlornated (DCM) and non-chlornated solvent waste gas streams from the pharmaceutcal manufacturng processes resultng n a new man emsson pont A2-1(c) wth the flows and lmts n the lcence remanng the same as per the exstng TO emsson pont A2-l(a) wth the addton of a HC lmt and Doxn/Furans lmt. On completon ). 2

3 of the commssonng phase of the new Totft s proposed that the exstng TO wll be decommssoned.,.. 1 : 3 l.... : 1-1. L 1, d 1 >, 1 s 4. Plannng Permsson, ES and EA Requrements 4.1 EA Screenng n accordance wth Secton 83(2A) of the EPA Act 1992, as amended, the Agency must ensure that before a lcence or revsed lcence s granted, that the applcaton s made subject to an envronmental mpact assessment (EA), where the actvty meets the1 crtera outlned n Secton 83(2A)(b) and 83(2A)(c). n accordance wth the EA Sfreenng Determnaton, the Agency has determned that the actvty s lkely to hpve a sgnfcant effect on the envronment, and accordngly s carryng out an assessment for the purposes of EM. 4.2 Plannna status : - The lcen?ee has provded a determnaton by Slgo County Councl that the modfcaton of the actvty (nstallaton of the new TO) consttutes development but s exemptdd development. A number;of plannng applcatons have been made by the applcant for prevous development of the ste of the actvty snce Detals of these plannng applcatons and permssons have been provded n the applcaton form. For the fr& plannng permsson granted n 2001 (PL01/481), Slgo County Councl (n conjunkon wth Slgo Borough Councl ) had determned that the development related to fhs actvty was lkely to have a sgnfcant effect on the envronment and that an EQ4 was requred. Tte plannng authortes requred an Envronmental mpact -Statement (ES) n support of1 the plannng applcaton for PL01/481. The applcant has submtted ths ES wth the lcence applcaton. (As part of ths lcence revew applcaton the lcensee also submtted a letter from Slgo County Councl confrmng that the plannng authorty dd not requre EA for any subsequent plannng applcatons.) Havng specfc regard to EA, ths report s ntended to dentfy, descrbe and assess for the Agency the drect and ndrect effects of the proposed actvty on the envronment, as respects the matters that come wthn the functons of the Agency, ncludng any nteracton between those effects and the related development formng part of the wder project, and to propose conclusons to the Agency n relaton to such effects. The ES submtted, the lcence applcaton, the submssons and observatons receved from thrd partes, the assessment(s) carred out by the plannng authorty, consultatons wth the plannng authorty, the relevant plannng decsons and any addtonal nformaton submtted by the applcant have been examned and assessed and are coysdered below for that purpose., 2 s T,- 1 ll Slgo Borough Councl was abolshed n May 2014; functons transferred to Slgo County Councl., 3

4 _ , 4.3 Content of ES and-lcence applcaton * have consdered and examned the content of the lcence applcaton, the' ES and other relevant materal submtted wth t. t was consdered that the ES, and lcence applcaton, dd not adequately address the followng areas and ths nformaton was requested under Regulaton 10(2)(b)() of the Envronmental Protecton Agency (ndustral Emssons) (lcensng) Regulatons 2013._ 1. An assessment of the mpact of potental doxn dscharges from the TO. 2. Annual solvent usage 3. Detals of ol separators nstalled on-ste. ' * On recept of further nformaton under Regulaton 10,. all of the documentaton receved was examned and consder that the nformaton as submtted contans a satsfactory descrpton of the project, the alternatves studed by the applcant, the aspects of the envronment lkely to be sgnfcantly affected by the actvty, the lkely effects of the actvty on the envronment, the forecastng methods used, the preventon and mtgaton measures envsaged, any dffcultes and defcences encountered and a non-techncal summary. consder that the ES, when consdered n conjuncton wth the addtonal materal submtted wth the applcaton; also comples wth the requrements of the PA (ndustral Emssons)(lcensng) Regulatons *... have consdered and examned the documents furnshed by the plannng authorty n relaton to the mpacts assessed by t, n partcular the planner's report and the plannng decson (ref. PL01/481). have consdered the ssues that nteract wth the matters that were consdered by the above authortes and whch relate to the actvty n Secton 13 of ths report. Havng consdered the applcaton and ES, the submssons of state and publc authortes, and the matters resultng from the plannng authorty decson, consder that the lkely sgnfcant effects of the actvty'on the envronment are as set out n Secton 12 below..,.- - ;. _.. t. 4...

5 ! 4.4 Consultaton wth Competent Authortes ' '\. Consultaton was carred out between Slgo County Councl and the Agency as follows: consuldton Notce under Secton 87(1E)(a) ssued: t Responsd to Secton 87(1E)(a) Notce receved: t l, Date 23 September 2015 to Slgo County Councl 10 November 2015 from Slgo County Councl Slgo Coulty Councl dd not provde any addtonal observatons to the Agency on the lcence applcaton and ES. ; 5. Submssons. $ one vald submsson made n relaton to ths revew. was receved from Ms Rta O'Grady, Prncpal Envronmental Health Health Servce Executve. n her correspondence, Ms O'Grady stated that a stejlvst was made by her colleagues on the 6 November 2015 and that at ths vst obseyatons were made on emssons to ar, surface water and sewer, as well as observatons on nose and waste. Ms O'Grady concluded that, on foot of observatons made, and subject to the exstng and proposed emssons beng n complance wth lcence condtons, her colleagues had no sgnfcant' concerns, from an envronmental health perspectve, n respect of the lcence revew. 6. Consderaton of Best Avalable Technques (BAT) and BAT Conclusons : Secton 86A(3) of the EPA Act 1992 as amended, requres that the Agency shall apply BAT conclusons as a reference for attachng one or more condtons to a lcence or a revsed lcence. Therefore, BAT for the nstallaton was assessed aganst the BAT conclusons contaned n the followng documents: Reterence Document on Best A valable Technques for the Manufacture of Organc Fne Chemcals (European Commsson 2006). BAT was +s0 assessed aganst the BAT Gudance Note for the Pharmaceutcal & Other Specalty Organc Chemcals (EPA 2008). Note that aspects of the followng reference documents also have relevance: Reference Document on Best A valable Technques for Common Waste Water and Waste Gas TreatmenvManagement Systems n the Chemcal Sect04 (European Commsson 2003). Reference Document on Best Avalable Technques for Energy Efcency, (Ehopean Commsson 2009). Reterence Document on Best Avalable Technques on Emssons from Stobage, (European Commsson 2006). 5 '

6 Reference Document on the General fthcpals of Montorng, (European Commsson 2003)., The assessment has demonstrated that the nstallaton wll comply wth all applcable BAT Concluson requrements specfed n the above BREF Documents and BAT notes. Regard was also had to relevant BAT Conclusons requrements for Envronmental Management Systems set out n recently publshed Commsson mplementng Decsons (CDs). Addtonal Requrement: 2 -, ' Condton/ Schedule, To control mn'mum operatng temperature and resdence tme n the new thermal oxdser (Sectons and, of the sectoral BREF) Schedule c.1.1 n the absence of a Commsson mplementng Decson (CD) or 'potental BAT' for the sectoral BREF, BAT assocated emsson levels (AELs), are taken from the current natonal BAT note for the sector (n ths case the BAT Gudance Note for the.,. Pharmaceutcal & Other Organc Chemcals).'.., t.,. 6

7 7. Emssons Emssons to Ar ), The man emssons to ar arse from the exstng and proposed thermal oxdsers, the cryogenc condenser, process scrubber, bolers and from dust exhaust systems. Mnor emssons on ste are assocated wth bolers and smaller vents from the producton: area. Th-ere are sx bolers on ste, two of whch are consdered man emssons (Al-1 and Al-2) BotQ of these bolers are fuelled by kerosene, but are only used as back-up durng peak demand. The ndvdual rated thermal nput of both these kerosene bolers s 6.31 MW. The remanng four bolers (Al-3 to A1-6) are fuelled by lqud petroleum 1 gas and are regarded as mnor emssons (ndvdual thermal nputs approxmately 1 MW). There are.7even other emsson ponts to ar at the nstallaton (A2-l(a), (b) and (c), and A2-2 fo A2-5 nclusve), all of whch, due to ther emsson characterstcs are regarded as man emssons to atmosphere. ' A2-l(a) sthe exhaust from the exstng TO, whch s used for destructng nonchlornated solvents n the process emssons. A2-l(b) s the ventng from the cryogenc kndenser; the condenser s generally lused to remove less volatle organc compounds from the process emssons and wll contnue to be used only as a backup to the proposed new TO. A2-l(c) s the emsson pont for ths proposed new TO, whch wll1 be used to destruct both 'chlornated and non-chlornated solvent *? 4 emssons \ram the processes. / A2-2 s the emsson pont for the process scrubber (used for removng hydrochlorc and formclacd from certan processes). 't A2-3, A2-4 and A2-5 are emssons ponts assocated wth the extracton of pharmaceutcal dust from the process buldngs. Condton 6.10 of the RD requres the lcensee to mantan a programme for, the dentfcatdn and reducton of any fugtve emssons usng an approprate combnaton of best avalable technques. 4t. \... mpact of Ar Emssons on the Recevng Envronment. As part of,the applcaton, the. applcant commssoned an Ar Dsperson Modellng Report for the emssons from the proposed extended nstallaton. The AERMOD Verson 7.7 modellng software was used to complete the ar dsperson modellng and predq the ambent pollutant concentratons resultng from all the major emssons lsted above. Fve years of hourly meteorologcal data for the Fnner Meteorologcal Staton was used; namely 2008 to 2010 nclusve, and 2012 to 2013 (data qualty for 2009 was consdered too poor for use n model). For background ar qualty, the modellng used 2013 Agency ar montorng data' (Zone C3). Complex terran data has been ncorporated nto the modellng assessment and buldng wake effects have also been taken nto consderaton. ' ' Ar Qualt Zone c ( regarded a Three grl terran dat )' o reland 2013, EPA 2014 largest towns n reland, excludng Dubln and Cork). Usng Zone C would be :onservatve, as the nstallaton, strctly speakng s located n Zone D (rural).,ystem(20km x 20 km; lokm x 10 km; 100 rn x 100m) ncorporatng dgtsed usng AERMAP), and data from engneerng drawngs of the nstallaton. 7 t

8 The modellng approach s based on the adopton of the followng worst case scenaro: 0 All major emsson ponts operatng smultaneously at the lcence lmts specfed n the current lcence PO All major emsson ponts operatng 24 hours a day, 7 days a week, 365 days a year. 0 Ambent ar qualty for Zone C was used for background concentraton. 0 Wth respect to NO2, the predcted envronmental concentratons (PECs) are based on the assumpton of 100% converson of NO, emtted from the thermal oxdser to NO2 n the atmosphere. The dsperson model n ths assessment was used to predct the mpact of emssons of oxdes of ntrogen, sulphur doxde and carbon monoxde, hydrogen chlorde, total organc carbon (TOC) and specfc pollutants (Classes and 1 organc substances as specfed n the sectoral BAT note), as well as doxns/furans. These are the pollutants whch are characterstc of the proposed ar emssons. As part of ths assessment regard was had to the EPA s Ar Dsperson Modellng from ndustral nstallatons Gudance Note (AG4) whch requres that the process contrbuton (PC) from ndustral nstallatons s added to the background concentraton (BC) to obtan the PEC. n order to assess the mpact, each PEC s compared wth an approprate envronmental assessment level (EAL). Dchloromethane (DCM) and Tetrahydofuran (THF) consttute approxmately 87 O/O of the proposed solvent loadng to the new TO. Therefore, for the purposes of assessng the maxmum hourly PECs of TOC, comparson has been made to the DCM and THF short term envronmental assessment levels (EALs) specfed n the UK Envronment Agency gudance, PPC HL5 DCM and THF are also representatve of Class 1 substances. Therefore, the UK EALs were also used for assessment of ths class of organc compounds. For Class organc substances, the modelled PECs were compared to the ar qualty standard (AQS) for benzene taken from the Ar Qualty Standards Regulatons, 2011 (S 180/2011). Benzene may be regarded as a Class organc substance but t s also a Class 11 carcnogenc substance as specfed n the sectoral BAT note, wth a strngent dscharge lmt and ambent standard. However, benzene s not used or ntended to be used at the nstallaton; but rather, the ambent benzene lmt s used as part of a conservatve assessment of Class organc substances. HC emssons were assessed aganst the short term EAL as set n the above UK EA gudance... Formc acd emssons were assessed aganst a short term EAL derved from a lmt set n the Publc Health England gudance6 and the UK EA gudance..,, For all other parameters above the approprate EAL s taken from the Ar Qualty Standards Regulatons, As can be seen from table 2 below, the PECs are below EALs for all relevant parameters at modelled emsson concentratons ndcated above. Emsson lmt Horzontal Gudance Note PPC H, UK EA 2002,. t Publc Health England, Formc Acd, ncdent Management, PHE publcatons gateway number: , October

9 ~ * -? values (ELVs) have been set wth regard to these emsson rates modelled by the applcant, as well as the BAT gudance note for the sector and the relevant legslaton on emssons. As the modellng ratonale s based on a very conservatve scenaro t s clearsfrom the table that the emssons to ar from the nstallaton wll not result n the breach' of the ar qualty standards beyond the boundary of the nstallaton. Table 2: Emssons to ar summarv EAC PECas Envronmental 'Cont. L..'--N 5 trog en 1 ; hourly 99.8Oole 23.3., 41.3, L , r Annual 0.44,,. r 1,) 3.44 (as DCM). Annual , " 800, ,

10 Doxns/Furans (PCDD/F)." The combuston of chlornated organc solvents can potentally lead to the formaton of Doxns/Furans f the correct thermal treatment controls are not mantaned. n order to mnmse the rsk of Doxns/Furans formaton, the TO must ensure that two key desgn crtera are met; Combuston s as complete as possble by mantanng 2 second retenton tme at >11OOOC - ths mnmses the rsk of pre-cursor organc compounds beng emtted from the combuston chamber. (n lne wth BAT) 0 The temperature reducton from lloooc to 200OC s acheved n an as rapd and controlled manner as possble to ensure the flue gas spends the mnmum tme wthn ths range. These operatng crtera have been confrmed as part of the commssonng test programme (whch s currently on-gong) specfed n Condton 6.1 of the RD. Ths condton specfes that the operaton crtera must be ncorporated nto the nstallaton's standard operatng procedures. Furthermore, the above mnmum combuston temperature and resdence tme have been ncorporated nto Schedule C: Control and Montorng of the RD. A conservatve worst case scenaro of the emssons lmt value of 0.1ng/Nm3 as per Part 3, Annex V of the ndustral Emssons Drectve (ED) has been modelled by the applcant. No AQSs for ambent doxns/furans are currently n force at natonal or European level. However, as a gude reference was made to ar qualty gudelnes ssued by the World Health Organ~aton.~ These gudelnes do not propose AQSs for Doxns/Furans because atmospherc exposure to Doxns/Furans s consdered low. Exposure to atmospherc Doxns/Furans accounts for 'less than 5%' of the daly ntake from food. Therefore, no drect comparson to an AQS can be made to determne whether predcted atmospherc concentratons should be consdered envronmentally 'sgnfcant. However, WHO does state that: 'Ar concentratons of 0.3 pg/m3 or hgher are ndcatons of local emsson sources that need to be dentfed and controlled'. On ths bass, the Doxns/Furans benchmark of 0.3 pg/m3 concentraton has been used to provde an ndcaton of whether predcted concentratons should be consdered envronmentally sgnfcant. Doxns/Furans have a range of vapour pressures and thus exst n both vapour and partcle bound states to varous degrees. The ar dsperson model submtted by the applcant assumes that all Doxns/Furans reman n the vapour phase. Gven that potental source of emssons s from the hgh temperature destructon of vapour phase solvents (as opposed to the ncneraton of lqud solvent waste, or muncpal waste, etc.) the assumpton that any doxns/furans would reman n the vapour phase n the vcnty of the nstallaton s deemed acceptable. WHO provdes an estmate of 0.1pg/m3 for urban ambent toxc equvalent ar concentratons of Doxns/Furans. The modellng results ndcate a maxmum predcted annual average concentraton of pg/m3. Combnng wth the estmated background value of 0.1pg/m3 gves a total concentraton value of pg/m3. Comparng ths to the benchmark fgure of 0.3pg/m3 ndcates that the predcted concentratons of Doxns/Furans resultng from the proposed thermal oxdser would not be consdered envronmentally sgnfcant. The applcable BAT gudance has outlned strngent abatement system operatng condtons n order to ensure that doxn formaton s mnmsed. The ED has outlned ar emsson lmt 7 Ar Qual@ Gudelnesfor Europe, Second Edton, World Health Organsaton (2000) 10

11 values for doxns whch have been set at 0.1. ng/nm3. The RD requres the lcensee to meet all the requrements of the ED, as well as fulfllng the requrements of BAT, and n dong so, based on the applcant modellng, protect human health. Solvent usage and Chapter V of the ndustral Emssons Drectve (ED) n addton, to the general requrements for ths class of actvty (5.16) under the ED *, Chapter.V of the same Drectve also specfes separate requrements for solvent related actvtes whch do not fall under the classes of actvty specfed n Chapter 1 of the Drectve. Chapter V refers to Annex V1 lo. '\ Secton 20, of Part 2 of Annex V1 specfes a Chapter V threshold of 50 tonnes per annum solvent consumpton ll. The nstallaton has hstorcally used varyng quanttes :of solvent per annum; wth the swtchover to the new processes, the proposed annual consumpton of solvents s '620 tonnes per annum. Therefore, Chapter V kequrements wll apply to ths nstallaton. 1 Secton 20:specfes that a TOC lmt of 20 mg/m3 s specfed for relevant emssons to ar. BAT for the sector also requres ths TOC lmt (t s also as proposed and modelled for by the applcant.) Therefore, the RD specfes a lmt of 20.mg/m3 for the proposed new TO. n accordance wth secton 20, the RD (Condton 5.6) also specfes tpat fugtve emssons must not exceed 15O/0 of the total solvent nput, where solvent consumpton s greater than 50 tonnes per calendar,year. n accordance wth Artcle 59 of the ED, Condton 5.5 of the RD specfes that any substance 'or mxtures whch, because of ther content of VOCs are assgned or need to carry t6e hazard statements H340, H350, H350, H360D or H360F, (or the rsk phrases R45, R46, R49, R60 or R61) must be replaced, as far as possble by less harmful sljbstances or mxtures wthn the shortest possble tme. For all man emssons potentally contanng volatle organc compounds wth specfc hazard/rsk phrases, the RD also specfes ELVs n accordance wth the requrements of Part N of Annex 7.2 Emssons to Sewer Wth the nstallaton of the TO, the average daly- volume of wastewater at the nstallaton: wll ncrease slghtly, by approxmately 2 m3/day. Accordng to the applcant the average daly dscharge from the nstallaton s approxmately 191 m3/day. Consequently the lcense does not requre an ncrease n the current allowable maxmum of 300 m3/day. Other sources of sewer dscharges are: drect and ndrect process wastewater from producton (ncludng the aqueous fracton from the nstallaton's solvent strpper); utlty waste water and santary wastewater. All wastewaters streams are combned and passed through the solvent strpper a second tme. Ths wastewater s then stored n a holdng tank, pror to testng and release to sewer. Other than the -L * DRECnVE 2010/75/EU OF THE EUROPEAN PARLAMENT AND OF THE COUNCL of 24 November 2010 on ndustral emssons (ntegrated polluton preventon and control) (Recast) CHAPTER V SPECAL PROVSONS FOR NSTALLATONS AND ACTVTES USNG ORGANC SOLVENTS 11 ' lo ANNEX V- Techncal Provsons For nstallatons And Actvtes Usng Organc Solvents. l1 Secton 2OlL Manufacturng of pharmaceutcal products 11

12 removal of solvent, the wastewater streams receve no other treatment pror to ther dscharge to sewer. These wastewaters are dscharged to rsh Water's sewer network for the Slgo agglomeraton. The Slgo agglomeraton ncorporates a muncpal waste water treatment plant (MWWTP), whch has secondary treatment (actvated sludge/phosphorous removal), and also ncorporates UV treatment. t has a desgn capacty of approxmately 50,000 p.e. The Slgo MWWTP fnal effluent dscharges to the transtonal waters of Garavoge Rver (Garavoge Estuary). These urban wastewater dscharges from the Slgo agglomeraton are lcenced by the Agency under waste water dscharge lcence (Reg. No. D ). The maxmum dscharge volumes from the nstallaton represent about of effluent dscharge volumes from Slgo MWWTP. The Agency's most recent natonal annual report on urban waste water" ndcates that the Slgo MWWTP s n complance wth the dscharge lmts for BOD and COD, but not n complance for ammona, total phosphorous and dssolved oxygen. However, gven the unchanged nature and' quantty of the dscharges, the proposed pollutant loadngs from the nstallaton are not predcted to mpact negatvely on the water qualty n the Garavoge Estuary, whch currently has a Water Framework Drectve (WFD) classfcaton of 'good' status. rsh Water, under Secton 99E of the EPA Act 1992 as amended, gave ts consent13 for the dscharges from the nstallaton, subject to certan condtons, emsson lmts, and montorng requrements whch have been ncorporated nto the RD. The emsson lmt values (ELV's) appled by the Agency to ths dscharge must satsfy the followng crtera: 1 ' The treatment provded on-ste at the nstallaton must satsfy the consent condtons specfed by rsh Water, as requred by Secton 99E of the EPA Act 1992 as amended. t must be demonstrated that the level of treatment of an nstallaton's effluent, on and off ste, s collectvely equvalent to BAT. BAT for the nstallaton's lcensable actvty s specfed n the BAT Gudance Note for the Pharmaceutcal & Other Specalty Organc Chemcals (EPA 2008) and the Reference Document on Best Avalable Technques for the Manufacture of Organc Fne Chemcals (European Commsson.2005). n grantng a lcence for an nstallaton, and n accordance wth Secton 83(5)(a)() of the EPA Act 1992 as amended, as well as n accordance wth Artcles 5 and 7 of S of 2009, the Agency must ensure that the qualty of any relevant recevng water s not mpared or that the relevant Envronmental Qualty standards are not exceeded. As can be seen from table 2 below, there are eleven parameters charactersng the dscharges from the nstallaton. As also can be seen from the table the majorty of the parameters have BAT assocated emsson levels (BAT-AELs) from the sectoral BAT note (no relevant emsson levels assocated wth 'Potental BAT' were ndcated l2 Focus on Urban waste Water Treatment 2013 ( PA 2014). - l3 Secton 99E response receved by the Agency on 12 November

13 the sectoral BREF). As part of ths assessment t was determned that these proposed lmts were n accordance wth BAT when on and off-ste treatment was taken nto account. The resultant concentratons specfed n column 4 below ndcate the maxmum concentraton of the nstallaton s effluent followng on and off-ste treatment. These maxmum concentratons are all well below the correspondng BAT-AELs specfed n column 2. Note that the fgures n column 4 are based on dluton on/% and do not take nto account any further reducton n concentraton acheved by the MWWTP treatment process tself. Also, comqarng columns 4 and 5, t can be seen that, at the pont of dscharge from the Slgo WWTP, t s hghly unlkely that the envronmental qualty standards14 (EQSs) for the Garavoge Estuary wll be breached due to the nstallaton s dscharges! (The estmated fgure of 6.75 mg/l for BOD would be much reduced when takg the treatment process at the MWWTP nto account; the Slgo MWWTP typcally acheves a 95% BOD reducton.), The proposed ELVs also nclude lmts for sulphates, chlordes and detergents. There s no BATAEL or assocated Potental BAT lmt for ths parameter; rather these lmts were: specfed by the water servces authorty (rsh Water), and n accordance wth sectop 99E of the EPA Act 1992 as amended, these lmts have been transposed n the Recommended Decson (RD). (1 7 and orthophosphate) for transtonal waters as specfed n Schedule 5 of European - Objectves (Sudace Waters) Regulatons 2009 as amended.

14 Grease! 7, f, The ELV's proposed above are, therefore, consdered to be n accordance wth current BAT for the sector, as well as 'potental BAT' specfed n the BREF document for the sector. The lmts, as specfed, also transpose the consent requrements of rsh Water, and furthermore, ensure that the nstallaton's dscharges would not result n the breachng the relevant EQSs for the Garavoge Estuary. Gven the above t s consdered that the recommended ELVs for ths dscharge to sewer are consdered to satsfy the requrements of the ED, the WFD, and the EPA Act 1992 as amended..,- Addtonal requrements by rsh Water As mentoned above, rsh Water.specfed lmts for lcensee's dscharges to sewer. These lmts are the proposed lmts n the RD, as detaled n table 2 above (column 3). n addton to the dscharge lmts, rsh Water also specfed 20 addtonal requrements relatng to the dscharges to sewer. Ten of these requrements are provded for n the standard condtons of the RD. However, the remanng ten requrements have been transposed nto the RD as new condtons. These are: Condtons 54.2, 5.4.3, 5.4.4, and mssons to Sewer; Condton 6.6 (Sewer Montorng); Condton (Sewer plans and detals); Condton (Summary report of daly montorng); Condton (advance notfcaton of dscharge alteratons) and Condton (montorng charges). 7.3 Emssons to Waters There are no process emssons to surface waters from the nstallaton. The only dscharges to surface waters are from surface water run-off. Ths uncontamnated run-off dscharges to a small stream that passes through the grounds of the nstallaton. The stream leaves the nstallaton and eventually jons the Garavoge Estuary approxmately 1.5 km downstream. 7.4 Emssons to Ground There are no emssons to ground or to groundwater from the nstallaton. The Baselne Report secton of ths report (see secton 10) provdes a summary n relaton to groundwater montorng and assessments whch have been carred out at the nstallaton. The RD requres bannual montorng of specfed wells for a range of parameters, as well sol montorng every ten years, thereby fulfllng the montorng requrements specfed n the ndustral Emssons Drectve.,, ( 7.5 Waste The man hazardous producton wastes are aqueous washng lquds and mother lquors wth halogenated and non-halogenated solvents. Waste ols, adhesves, sealants, contamnated packagng, norganc chemcal waste, laboratory, waste and other hazardous wastes typcal of the sector are also generated on-ste. These hazardous wastes are exported for dsposal/recovery. The majorty of the other producton wastes generated by the current actvtes are and wll be recyclable or recoverable, eg. Scrap metal, plastc packagng, tmber, cardboard and glass. Mxed muncpal waste from the nstallaton s sent to landfll.. --> 14

15 The RD requres that dsposal or recovery of waste on-ste shall only take place n accordance wth the condtons of ths lcence and n accordance wth the approprate Natonal and European legslaton and protocols. 7.6 Nose There s audble plant nose from the external pumps of the tank farms, the process buldngs extracton fans and the compressed ar lnes. Other nose sources nclude the coolng towers ar compressors, bolers and the thermal oxdser. Baselne nose montorng was carred out as part of the ES, whch was submtted as part of the orgnal lcence applcaton. Ths baselne report ndcates nose levels were g,enerally OW, although there was some local traffc and actvty nose;.e. mnmal nose pror to ntal development at the ste. 1,, As part oftthe current lcence, a nose montorng survey s carred out annually at four ndvdual nstallaton, boundary locatons, as well as at t three nose senstve receptors outsde the boundary. Hstorcal data from these surveys ndcate that the nstallaton: s consstently complant wth the lcence lmts., j t s on tqs bass that the applcant has proposed to conduct a nose survey to ncorporate the new TO, and that ths would be the fnal survey f the results were wthn the' lcence lmts. Dscussons held between ths nspector and the OEE concluded that, rather than the complete removal of the nose survey requrement, ts frequenp could be reduced.,, 1 *, Condton 4.3 and Schedule B4: Nose Emssons control the nose mpact at NSL's; Schedule 6.4 also specfes that there shall be no clearly audble tonal component n the nose /emssons from the actvty at!any NSL. n accordance wth Agency gudance, pose lmts and montorng requrements n the RD are specfed n terms of evenng tme (as well as day tme and nght tme). Condton 6.16 offthe RD provdes fr a'change n the frequency requrement for a nose survey; n lght of ongong complance at the nstallaton, the RD specfes that the survey should be carred ouga frequency to be agreed by the Agency (nstead of annually as currently specfed.)!: - < \ 1 c 8. Use of Resources The operaton of the nstallaton nvolves the consumpton of water, ol and electrcty. The estmated quanttes used n 2014 are g6en below. ' ' Electrcty Lqufed Petroleum Gas Kerosene Water t L 10,737,000 kwhr 468 m3 1,134 m3 83,950 m3.' n addton, over seven tonnes of DCM (R40 - lmted evdence of carcnogenc effect) and over nne tonnes of dmethylformamde (R61 may cause harm to unborn chld) are used ;fnnually on-ste. Respectve stored amounts of both substances are approxmately 28 tonnes and 10 tonnes. 2 tonnes of 2-methoxyethanol s also stored 15

16 on-ste, as well small amounts of Celpure 1000 flter agent (R48 - Danger of serous damage to health by prolonged exposure). None of the above substances are emtted drectly to the envronment. 9. Measures to be taken to prevent accdents and lmt consequences The- applcaton detals a range of measures that wll be' employed to prevent 8 ' accdents and lmt consequences. These nclude: - - Equpment desgn features Bundng and contanment,. - Storage & transport nfrastructure and practces - Tranng & procedural control - nspectons - Contngency plans & emergency response procedures. _. Condton 9 of the RD requres procedures to be-put n place to prevent accdents wth a possble mpact on the envronment and to respond to emergences so as to d. mnmse the mpact on the envronment. 10. Measures to be taken upon cessaton A baselne report was submtted wth the applcaton. The ste has prevously been used for agrculture only, wth no evdence of other past uses, pror to the constructon of the orgnal buldngs. The report refers to data from 2015 groundwater analyss as requred under the current lcence. The groundwater montorng results ndcate elevated levels of conductvty, chlorde, chlorde, sulphate, ron and manganese. Hstorcally, slghtly elevated and/or sporadc levels, of COD, orthophosphate, ammona and sulphate n the groundwater have been observed. The report concludes that ths contamnaton s due to agrcultural actvty up-gradent of the nstallaton. The aqufer beneath the ste, whch s part of the Drumclffe-Strandhll groundwater body s a locally mportant bedrock aqufer (The groundwater body s classfed as 'good' for the purposes of the WFD; and s classfed as 'Possbly at rsk' (rsk source not specfed)). The report concludes that the rsk of contamnaton of sol/groundwater due to the actvty s low; on the bas's of the followng provsons:, - mpermeable concrete surfaces n all areas assocated wth the handlng and storage of potentally contamnatng materals. - Approprate bundng for all tank and drum storage areas, wth routne ntegrty testng - Approprate dranage ncorporatng frewater retenton facltes. t A Decommssonng Management Plan (DMP) and An Envronmental Labltes Rsk assessment (ELRA) have also been submtted wth the applcaton (see secton 11 below). r L 16

17 n concluson the ste s currently uncontamnated and the rsk of contamnaton from the actvtes at the nstallaton s low due to the nature of the operaton,and the proposed measures as descrbed above. The RD requres sol montorng for relevant hazardous substances to be carred out every 10 years, and groundwater montorng (for relevant hazardous substances) to be carred out evew 5 years, n accordance wth the requrements of the ED. 11. Ft & Proper Person Assessment The Ft & (roper Person test requres three elements of examnaton: Tech n ca Ab ty..,. The lcende has provded detals of the qualfcatons, techncal knowledge and experence of key personnel. The lcence applcaton also ncludes nformaton on the on-ste management structure. t s consdered that the lcensee has demonstrated the techncal knowledge requred. Lecla Standng Nether the lcensee nor any relevant person has relevant convctons under the Envronmental Protecton Agency Act 1992, as amended, the Waste Management Act 1996, as amended, the Local Government (Water Polluton) Acts 1997 and 1990, the Ar Polluton Act 1987 and the Ar Polluton Act 1987 (Envronmental Specfcatons for Petrol and Desel Fuels)(Amendment) Regulatons ! F na nca Stand nq n 2013, under the current lcence (PO643-02), the lcensee commssoned a DMP and an EL@ for the nstallaton, whch were costed at approxmately 5,973,000 and 1,866,000 respectvely. n 2015 fnancal provson (parent company guarantee) for 9,162,000 was approved by OEE. A revsed DMP and ELM were submtted as part of ths revew applcaton and were costed n accordance wth the Agency s latest gudance1! The revsed costs were 7,466,000 and 1,866,000 respectvely, whch would be $ lne wth the current approved fnancal provson. n any event, a revew of both DMP and ELRA, as well as approval of Fnancal Provson, s requred under the RD.. 8 t s consdered, on the bass of the nformaton suppled n the applcaton, and on consultaton wth the OEE, that the applcant meets the requred techncal and fnancal requrements and can be deemed a Ft & Proper Person for the purpose of ths revew applcaton. 17

18 12. Complance wth Envronmental mpact Assessment Drectve (85/337/EEC) The followng secton dentfes, descrbes and assesses the lkely sgnfcant drect and ndrect effects of the proposed actvty on the envronment, as respects the matters that come wthn the functons of the Agency, for each of the followng factors: human bengs, flora, fauna, sol, water, ar, clmate, the landscape, materal assets and cultural hertage. The man mtgaton measures proposed to address the range of predcted sgnfcant mpacts arsng from the actvty have also been outlned. The cumulatve mpacts wth other developments n the vcnty of the actvty have also been consdered, as regards the mpacts of emssons from the actvtes. Ths secton must be read n conjuncton wth the analyss carred out n all sectons of ths report. Nose nusance Ar polluton ncdent/accdent Descrpton of effect, ' Potental nose actvty at NSb from manufacturng process. Ar qualty mpacts on human health as a result. of operatons e.g. thermal oxd ser Potental for drect and ndrect mpacts on human health from fre/exploson or spllage from on-ste solvent usagelstorage 'and any ncdent accdent leadng to from ar, water, q round/q rou ndwater contamnaton. Assessment addressed n secton: 12(a)(). 12(a)(). 12(a)( ) Assessment of Effects on Human Bengs 12(a)() Nose Nusance As dscussed n secton 7.6 above, the man sources of nose emssons from the nstallaton are assocated wth the external pumps of the tank farms, the process buldngs extracton fans and the compressed ar lnes. Other nose sources nclude the coolng towers ar compressors, bolers and the thermal oxdser. There has been no hstory of nose complants n recent years at the nstallaton and results from recent annual nose surveys ndcates the operaton of the extended plant wll not result n a breach of the lcence lmts. Mtgaton Measures Man external nose sources located to the rear of the ste n order to maxmse the dstance to the nearest nose senstve receptor. 0 Condton 4.5 and Schedule 84: Nose Emssons controls the nose mpact at NSL's. Condton 6.17 of the RD ncludes a requrement for a routne nose survey. Concluson am satsfed that there wll not be sgnfcant effects on human bengs and other nose senstve receptors from the operaton of the actvty. 18.,

19 Accordngly, f the actvty s carred out n accordance wth the RD and the condtons attached, the operaton of the actvty wll not cause envronmental polluton and the rsk of accdental emssons occurrng s low. The condtons of the RD and the mtgaton measures proposed are approprate to mnmse the rsk of accdental emssons occurrng and adequately lmt the envronmental consequences of an accdental emsson should one occur. ' 12[a)[) Ar qualty $ 1 1 ' As dscussed n secton 7.1 above, the man emssons to ar arse from the exstng and proposed thermal oxdsers, the cryogenc condenser, process scrubber, bolers and from, dust exhaust systems. Mnor emssons on ste are assocated wth bolers/combuston and smaller vents from the producton area. The modelled mpact of emssoqs to ar from the nstallaton was assessed. 1- The modellng was done on the scenaro of all major emsson ponts operatng contnuouqly at the proposed lcence. lmts. The nstallaton, f operated n accordancy wth the condtons of the lcence, s not expected to cause breaches of the relevant ar qualty standards. F,t Mtgaton heasures Sgnfcant abatement on all man emssons to ar, ncludng' a thermal oxbser, cryogenc condenser and HEPA flters. a Thkrmal oxdser (TO) operates to BAT standards (<lo50 deg C, < 2 sec resdence tme) to ensure the destructon of any doxns/furans formed n the thefmal treatment process. a Abatement of NO, emssons from the TO s provded by the selectve non- catalytc reducton unt. t Ab7tement of HC emssons from TO s provded by caustc scrubber unt. ELVs (Schedule B) have been set wth regard 'to these emsson rates mopelled by the applcant, as well as the BAT gudance note for the sector 1, and the relevant legslaton on emssons. a,condton 5.2 specfes that no emssons from the nstallaton;. ncludng odours, shall result n an mparment of, or an nterference wth amentes or the'envronment beyond the nstallaton boundary. Concluson.. L, am satsfed that there wll not be sgnfcant effects on ar, from the operaton of the actvg. am also satsfed that there wll be no,subsequent ndrect effects on human bengs, flora and fauna. Accordngly, f the actvty s carred out n accordance wth the RD and the condtons attached, the operaton of the actvty wll not cause envronmental polluton and the rsk of accdental emssons occurrng s low. The condtons of the RD and the mtgaton measures proposed are approprate to mnmse the rsk of accdental emssons occurrng and adequately lmt the envronmental consequences of an accdental emsson should one occur. 19

20 12(a)[) ncdent/accdent The aspect of the lcensed actvty wth the most potental for ncdent/accdent s consdered to arse from the use and storage of solvents on ste. Generally speakng, n any solvent-based manufacturng process there s potental for accdental spllages, leaks and fres wth subsequent potental for mpact on ar,> sol, ground/groundwater and personnel. Also process effluent whch dscharges ndrectly va the Slgo MWWTP nto the Garavoge Estuary, has the potental to convey lquds from accdental spllages, leaks or fre water.! 1, Mtgaton Measures Process dscharges must comply wth lcence condtons before dscharge to sewer; otherwse dscharges are recycled for further on-ste treatment. The lcensable actvty s carred out nsde the man buldngs. These buldngs have mpermeable concrete floors, wth potentally pollutng substances stored n desgnated areas wth approprate secondary contanment. The desgn and constructon of the contanment s n accordance wth Agency gddance. Lkelhood of groundwater contamnaton s much reduced, as the all bulk storage tanks are bunded, all process ppework s above ground; the process dran s also double contaned. A shut-off valve s nstalled on the outlet of the storm water retenton whch wll be actvated n the case of ncdent/accdent to prevent the dscharge of contamnated surface water to the onste stream., Condton 3.7 requres bundng and leak detecton systems; Condton 3.10 requres a Class full retenton nterceptor on storm water dscharge from yard areas and slt traps on all storm water dscharges, other than from roofs; Condton 3.11 requres the use of fre-water retenton facltes at the nstallaton; Condton 6.8 of the RD requres all abatement systems-to be calbrated and mantaned ; Condton 6.14 requres trgger levels for TOC to be establshed such that storm water exceedng these levels wll be dverted for retenton and sutable dsposal; Condton 9 requres Accdent Preventon and Emergency Response Procedures to be mantaned, and; Schedule C of the RD requres the lcensee to mantan approprate access to standby and /or spares to ensure the operaton of the abatement systems.

21 Lkely sgnfcant effect 1. Ar polluton Water polluton 4 1 # t Assessment of Effects on Flora and Fauna 12(b)( Water Polluton Effect Descrpton of effect 9..~ assessedn secton: Ar qualty, mpacts, mpactng 12(a)() and flora/fauna durng operaton. E.g. 12(a)() Emssons from thermal oxdser Water qualty mpactng flora/fauna 12( b)() and ther habtats from operaton of the actvty e.g. Process water dscharge. Contamnated surface water run-off. As dscussfd n secton 7.2, 7.3 and 7.4 above, there are no drect emssons to water; rather ndrect emssons to water arse from the process dscharge (as well as from santary dscharges), whch are treated on-ste before beng dscharged to the rsh Water sewer, wth subsequent treatment at the Slgo MWWTP before fnal dscharge to the Garavoge Estuary. Natura 2000 stes wth hydrologcal lnks to the dscharge are the Cumeen Strand/Drumclffe Bay SAC (Ste code: ) and the Drumclffe Bay SPA (Ste code: ), of whch Garavoge Estuary forms a part (see also Approprate Assessment screenng n ths report). Secton 7 of ths report goes nto consderable detal n the assessment of the proposed dscharge s mpact on the recevng waters. On foot of ths assessment, lmts were specfed whch am to ensure that the nstallaton s dscharges would not result n the breachng the relevant EQSs for the Garavoge Estuary. There s potental for groundwater to be polluted from fres and accdental spllages on ste. However, n addton to the surface water/groundwater protectng nfrastructure descrbed above, the RD specfes varous condtons to sgnfcantly reduce the lkelhood of any such spllage. 21

22 Mtgaton Measures n addton to the mtgaton measure below, the measures lsted n secton 12 (a)() also apply to mtgaton of water polluton. ELVs for process dscharges (Schedule B) have been set wth regard to the EQSs for the recevng waters, as well as the.bat gudance note for the sector and the relevant legslaton on emssons. Lkely sgnfcant effect. Sol contamnaton. Descrpton of effect Contamnaton from accdental spllages e.g. tank/bund falure. Assessment Addressed n Secton 12(a)( ) Assessment of Effects on Sol See assessment and concluson documented n secton 12(a)(). 12(d) Water Lkely sgnfcant effect Water Polluton. Descrpton of effect., - mpacts on water qualty durng operaton e.g. Process water dscharge.. Effect assessed n secton: 12(b)() ( Contamnated surface water run-off. _ ' 12(a)() Assessment of Effects on Water See assessments and conclusons documented n secton 12(b)() and 12(a)(). c ',, 22

23 Lkely sgnfcant effect Ar polluton Descrpton of effect Ar qualty mpacts durng operaton e.g. dscharges from thermal oxdser and cryogenc condenser. 3 assessed Effect n secton: 12(a)() Lkely sgnfcant effect Greenhouse gas producton Descrpton of effect Effect a ' assessed n J secton: Emssons of CO2 to atmosphere from l2(f)() bolers/combuston at the nstallaton 12[Q[) Greenhouse sas producton,. f.. The' operaton of bolers and combuston processes at any nstallaton wll contrbute to the accumulaton of greenhouse gases COz n the atmosphere, r thereby contrbutng to clmate change. As dscussed n secton'7.1, there are sx bolers onste, fuelled on LPG and kerosene. Two of these bolers have been determned to be man emssons. The operaton of the TO s a combuston process, and smlarly produces CO,. > ' > Mtgaton Measures '>[. j Thf RD requres energy effcency and. resource use effcency to be addressed as part of the Resource Use and Energy Programme (Condton 7) 0 Energy. audts are carred out annually at' the nstallaton; wth recommendatons ncorporated nto the EMS. New TO more effcent than exstng TO; nc0rporatn.g varable speed drve motors and heat recovery from the' exhaust gases... ' Concluson am satsfed that there wll not be sgnfcant effects on clmate from the operaton of the actvty., Accordngly, f the actvty s carred out n accordance wth the RD and the condtons 'attached, the operaton of the actvty wll not cause envronmental polluton and the rsk of accdental emssons occurrng s low. The condtons of the RD and the mtgaton measures proposed are approprate to mnmse the rsk of accdental emssons occurrng and adequately lmt the envronmental consequences of an accdental emsson should one occur. 23

24 ~ * 12(g) Landscape, Materal Assets & Cultural Hertage Lkely sgnfcant effect. Archaeology and archtecture. Landscape and vsual mpact. Descrpton of effect Dsturbance or damage of archaeology and archtecture from actvty at the nstallaton. The potental for the operaton of the actvty to negatvely mpact the landscape and have a vsual mpact... Assessment Addressed n Secton 12(g)() Use of natural resources and generaton of wastes Water, ol, and electrcty wll be used n the operaton of the actvty. Hazardous materals wll be used on ste Quanttes of other wastes wll also be produced as part of the lcensable actvty, such as WWTP sludge * * 12(g)( ) Assessment of effects on landscape, materal assets and cultural hertage -Dsturbance of archaeology and archtecture.. < The ES noted that there were three features16 of archaeologcal or- cultural sgnfcance wthn the nstallaton boundary. These features were protected durng the orgnal constructon phase of the nstallaton. The ES stated that current and proposed emssons from the operaton of the actvty are unlkely to mpact on any such features. ~-, '. - ' Mtgaton Measures.. S No partcular mtgaton measures are proposed n the RD. Concluson am satsfed that there wll not be sgnfcant effects on archaeology and archtecture from the operaton of the actvty, ncludng the operaton of the new TO. Accordngly, f the actvty s carred out n accordance wth the RD and. the condtons attached, the operaton.of the actvty wll not cause envronmental polluton and the rsk of accdental emssons occurrng s low. The condtons of the RD and the mtgaton measures proposed are approprate to mnmse the rsk of accdental emssons occurrng and adequately lmt the envronmental consequences of an accdental emsson should one occur. -Landscape and vsual mpact. The nstallaton s located n a sem-rural area at the outskrts of Slgo town. The ste and mmedate surroundng area are a type of landscape whch s common n the area and vsually robust on account of the number of small vsually self-contaned valleys. The operaton of the actvty s unlkely to mpact on the landscape of the area. -. Mtgaton Measures 16 Rngfort SMR No: 014:025, Rngfort SMRNo:014:024, Mll SMRNo: 014:023 24