janssen f i 1: . f Janssen Sciences Ireland UC

Registered aadress: Eastgate Village, Eastgate, Little Isiand, Co. Cork, Ireland Manufacturing site address: Barnahely, Ringaskiddy, to . Cork, Irelsnd -353 21 497 3000 tel +353 21 497 3030 fax

www.janssen.ie

’I 5th October, 201 8

Dear Sir/Madam

Janssen Sciences Ireland UC acknowledges rec Determination (Licence PO778-02), dated 1 gth September 201 8.

Having reviewed the Conditions and Schedules of the Proposed Determination in detail, in accordance with Section 87(5) of the EPA Act 1992 as amended, Janssen Sciences Ireland UC would like to lodge the following objections and observations to the Proposed Determination (Licence PO778-02).

Name of the Objector: Address of the Objector: Reference:

Janssen Sciences Ireland UC Barnahely, Ringaskiddy, Co. Cork IE PD Ref. No. PO778-02

In this regard, please find enclosed receipt (Attachment A) regarding payment of fee for €253 as specified in Article 8(2) of the EPA (Licensing Fees) Regulations 1994 to 201 3 as amended.

In accordance with Regulation 25 of the EPA (Industrial Emissions) (Licensing) Regulations 2Oq 3, the grounds for the objections and the reasons, considerations and arguments on which the objections are based are presented as follows:

Objection to Condition I Schedule

Cond. 1.2

Janssen’s Observations

I’ Condition ?. 2 Activities at this installation shall be limited as set out in Schedule A.”

“Schedule A: Limitations A. ? Organic Solvents Organic solvent consumption in the manufacture of pharmaceutical products shall be less than or equal to 50 tonnes per year”

Janssen is seeking to amend the text of Schedule A to read as follows:

“A. I Organic Solvents Where >50 tonnes per year consumption, compliance with the relevant requirements of Chapter V and Annex V// of the /E Directive 201OflWEC must be demonstrated.”

Directors: D m a ! O‘fonnell Kyran lohnson Emmet Crcnin Jeanne Bolger Carol Leland Kenneth Simmen (UK) Dave Gee!an Thierry Dernoncheaux (FR) Reglna Mulhall Basant Sharma (US)

VAT N” l i 970719IE Irlsh ReglCrztlon No 472372

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janssen c . IP.. f w-

Whereby consumption as per defined within the IE Directive: “Consumption means the total inpuf of organic solvents into an installation per calendar year, or any other .1 2-month period, less any volatile organic compounds that are recovered for re-use.

As per Janssen’s communication in the RFI Response dated 21“ May 2018, Appendix E.2 “Response to EPA RFI 4 (ii) - VERDE Report 51796: Solvent Mass Balance April 2018”, please refer to Section 4.2. For the purposes of this Objection an excerpt from the report is included in Attachment 6. Whilst Janssen does not foresee exceeding the 50 tonnes per annum for the initial stages of the BioCork 2 expansion (approximately 42 tonnes per annum), it is predicted that the threshold will be exceeded in the latter stages of the BioCork 2 expansion and for this reason Janssen requests revision to the above Schedule A text, whereby upon exceedance of 50 tonnes per annum solvent

I consumption threshold, compliance with the relevant requirements of the Chapter V and Annex VI1 of the IE Directive would be demonstrated.

To this effect Janssen requests that the text of Schedule 6.1.4 is revised to account for Annex VI1 of the IE Directive (specifically Part I (8) and Part 2 Activity # 20 - Manufacture of pharmaceutical products (>50) (solvent consumption threshold in tonnes per year))

I

Parameter

VOC

Proposed Revised Schedule B.1.4

Emission Limit Values (ELVs) Note I Monitoring Note

ELVs in waste

gases (mg C/Nm3)

20 Note2

Fugitive ELVs

(percentage of solvent

input) 5 Note 3

Total Frequency

5% of Annually solvent input

Method

Solvent mass balance methodology outlined in the Industrial Emissions Directive and in the EPA Air Advice Note No. 1 : Good Practice for Solvent Mass Balance and Fugitive Emissions Assessments for EPA Licensed Sites.

Note 1: Applicable where Solvent consumption >50 tonnes per year Note 2: If techniques are used which allow reuse of recovered solvent, the emission limit value in waste gases shall be 150. Note 3: The fugitive emission limit value does not include solvent sold as part of products or mixtures in a sealed container.

Inclusion of the following IE Directive Chapter V Definitions within the glossary to the IE Licence or as notes to the above Schedule B.4.4 Table:

Directors: Dcnel C‘ConzalI Kyran Johnsor: Emmet C:on!n Jeanne 30;Ger Czrol Leland Kenneth Slmmen (UK: Dave Gee!afi Thierry Demoncheaw (FR) Regina Mulhall Basant Sharrna (US)

L VAT NE I€ 3707191E

Irlsh Registration Na 472372

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janssen , I ->l t “waste gases” means the final gaseous discharge containing volatile organic

compounds or other pollutants from a stack or abatement equipment into air

”totaal emissions” means the sum of fugitive emissions and emissions in waste gases;

Objection to Condition I Schedule

Schedule B.1.3

Schedule B.2

Janssen’s Observations

B.1.3 Odour Emissions Control Monitoring Emission Point Reference No.: A3-23

Description of Treatment: WWTP Odour Abatement Biofilter

Janssen requests the inclusion of Note 2 to read as follows:

“Note 2: A3-23 will be decommissioned following commissioning of A3- 126, thereafter the requirement to monitor A3-23 will cease from January 2020. ”

Emissions to Water (via IDA pipeline)

Janssen require that the amended Daily average mgll limits and the newly included Yearly average mgll limjts as specified within Schedule B.2 do not apply until such time as the new WWTP upgrade project is compjeted.

Construction and commissioning works associated with the WWTP upgrade will not be completed until January 2020 and until such time as January 2020 Janssen will not have the infrastructure in place to be able to meet the revised limits as specified within Schedule B.2.

Janssen request that the existing daily average mg/l limits within the current licence remain in place until January 3Ist, 2020, thereafter the proposed amended Daily Average and Yearly Average mg/l limits would apply from Is’ Feb 2020 as per the following proposed revision to Schedule 6.2 Table.

This requirement does not contravene any of the following: the content of the ElAR as submitted as part of the 1E Licence Review Application, the requirements of the Common Waste Water BAT Conclusions (detailed submission as per RFI submitted to EPA 2Ist May 2018 (RFI 2)) Cork Harbour Impact Assessment (submission as per RFI submitted to EPA2ISt May 2018 (RFI 6)) Irish Water Section 99E Response (copy of correspondence included in Attachment D)

Directors: Dcnal O’tonneli Ernmet Crol?ir? Carol Leland D e w Geeiai Regira Mulha!l

Kyran Johnson Jeanne Bolger Kenneth Simmen [UK) Thierry Demoncheaux (FR) Basant Sharrna [US)

VAT No IE9707191E IFsh Reg1stra:’oi Ho 472372

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Proposed Revised Schedule B.2

B.2 Emissions to Water (via IDA pipeline)

Emission Point Reference No: Monitoring point reference code: Name of Receiving Waters: Location:

SE1 (1 77088E 64046N) SEMPI (177149E 64125N) Dognose Bank, Cork Harbour &&i&South-eastern corner of site, south of wastewater treatment plant.

Parameter I iitoring No*

Anslyms Method Erntdon Limit Value

1200 matday Note

I00 m3/hour

Frequency

Continuously

Daily

On-line flow meterwith recorder Volume I

30 OC (rnax.) Continuously On-line temperature probe

with recorder pH electrode/rneter with 6.0-9.0 Continuously recorder

Standard Method Annually 10 lu I I I Daily average Yearly

Daily average msl’

Jan 20201

mgll (from 1st Average mgll Feb 2020 (from 1st Feb onwmrds) 2020 onwards#

Frequency Analysis Method l

Monthly Standard Method BO 40

300 300 200 Weekly Standard Method

ITotal Suspended Solids 50 I 35 I 15 Weekly EN 872

Monthly EN 12260 Total Nitrogen (as N) a0 50 25

20 6 3 Quarterly Standard Method

20 I 20 I - Monthly Standard Method

Sulphate (Sod) I I 200 I 200 I - Quarterly EN 9377-2

Frequency Analysis Method Performance rate (yearly

average)

IC00 Abatement Eficiency - I >go% Daily Plant pemonance test

Quarterly Standard Method

Standard Methad

Standard Method

Monthly

~ Annually

Detergents

Full MHal Suite

- I ~ As required Standard Method

~ Annually Standard Method

_. 4

VAT N” IE 9707191E irish Pegktration ND 472372

Directox: Dona1 O’Conrel[ Emmet Cronin Cziol Leland Dave Geelan Reglna Mulhall

Kymn Johnson Jeanne Wger Kenneth Simmer. (UK) Thlerry 3ewoichwux (FR) Basant Sharma (US)

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Objection to Condition I Schedule

Schedule 6.4

Janssen's Observations

Monitoring of Storm Water Emissions

Janssen requests that the monitoring requirements as specified within Schedule 8.4 for pH, TOC, Temperature, COD, Total Ammonia, Total Nitrogen and Conductivity apply only to SEMP 3 for the following reasons:

Storm water from all process areas is continuously monitored and controlled. Storm water from all process areas on site enters the firewater retention pond via two locations SEMP 3 (BioCorkl) and SEMP 5 (BioCork2). Storm water samples from SEMP 5 are pumped to SEMP 3 for continuous pH and TOC monitoring of the combined storm water samples. Please refer to LR035668 for further details. Should results exceed the trigger limits for pH and TOC the control valve on the firewater retention tank exit closes preventing any potential contaminated storm water leaving the site. Please refer to Attachment C schematic. As per Licensee Return LR002117 (May 2013) Janssen sought the removal of all monitoring requirements on the outlet from the firewater retention pond at SEMP 2 as all storm water streams entering the pond are continuously monitored via SEMP 3. The removal of monitoring requirements at SEMP 2 (i.e. removal of requirement to monitor for pH, TOC, Temperature, COD, total ammonia, total Nitrogen and conductivity) was duly granted by the €PA on the 14" May 201 3 via LR002117 and associated monitoring infrastructure was subsequently decommissioned. Similarly for SEMP 4, regarding IE Licence TA Amendment B, LR024239 (Oct 2016) concluded that weekly monitoring of TOC, pH, Conductivity, visual inspection and odour assessment be carried out. Within the I E Licence Review Application Janssen sought the discontinuation of this monitoring requirement as SEMP4 emissions enter the firewater retention pond via SEMP3 and as per outlined above are subject to continuous pH and TOC monitoring and subsequent control on the firewater retention pond outlet. All storm water runoff from car park areas passes through appropriate oil interceptors prior to discharging via SE2

Janssen propose that a weekly visual inspection at SEMP 2, 3, 4 and 5 is maintained and that the requirement for daily visual inspections be removed from the proposed determination.

r

Directors: Dona1 O'tcnreil Emmet Cronin Carol Leland Dave Geelan Reglrla Mclkall

Kyran Johnson Jeanne Eolger Kenneth Simmen (UK) Thierry Demoncheaux (FR: Basant Sharma (US)

VATN" IE9707IQ?E Irish Registrziion No 472372

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Proposed Revised Schedule B.4

Parameter Trigger Level Monitoring Frequency

Visual Inspection at Weekly SEMP 2.3 4 and 5

8.4 Monitoring of Storm Water Emissions

Analysis MethocUTechnique

Sample and examine for colour and odour

Emission Point Reference No: Monitoring Point Reference No:

SE2 SEMP 3

Monitoring Point Reference No: SEMP 2,3,4 and 5

Janssen Sciences Ireland UC believe that the above observations serve to accurately reflect the operations on site post expansion and are within the best interests of the receiving environment and the site to ensure an effective and representative IE Licence.

Should you have any queries on the attached, please do not hesitate to contact me.

Yours sincerely

U Pat Fitzgerald EHS&S Lead, Janssen Sciences Ireland UC

- - - . - . 6

Dire&-: Dona! O'Connell Kyran Johnson VAT No IE 97371 91 E Emmet Cronin leanne Bolger Irish Registration No 472372 Carol Leland Kennekk Simnmen (UK) Dave Geelan Thierry Dernoncheaux (FR: Regha Mulhall Basant Sharma (US)

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ATTACHMENT A

Objection Fee Payment Receipt

. . I_ _._-.-_ ~ - - - - 7

- .- Directors: Dona1 O'ConneJ Kyran Johnson VAT N" :E 970719?E

Emmet Cronin Jeanne Bolger ffish Registratior: No 472372 Carol Leland Xannetb Slrnrnen (UK) Dave Geelan T h i e q Demoncheaux (FR) Regina MuIhaii Basant Sharma (US)

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RECEIPT

Ireland

253,00EUR

I

VlSA

globaipa yments

D l r e E o ~ : Dona! O'Conrel! Emrnet Cmnin Carol Leland Dave Geelan Regina Muhai l

Kyran Johnscn Jeanne Bolger Kenne:h Simmen (UK) Thierry Demoncheaux (FRj Basant Sharma (US)

VAT N" 1~9707191E Irish Registration No 472372

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ATTACHMENT B

Excerpt from Janssen's RFI Response to EPA dated 2Is' May 2018: Appendix E.2 "Response to EPA RFI 4 (ii) - VERDE Report 51796: Solvent Mass Balance

April 2018", Section 4.2.

Directors: Donal O'Connell Emmet Cronln Carol Leland Dave Geeian Regica Mulhai

Kyran lohnson Jeance Boiger Kenneth Sirmen (UK) Thieny Dernoncheaux (FR) Basant Sharrna (US)

a VAT N" IE 9707191E

Irish Reglstration K a 472372

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- - - -. _.. - . _ . . _ - _ _ . L " 11.-__... -11

10 Directors: Dona; O'Cannel! Kyran Johnson VAT N" [E Q707f91E

Ernmet Cronln Jeanne Edger Irish Reg:stration Na 472372 Carol Leland Kenneth Sirnrnen (UK) Dave Geelan Thierry Demoncheaux (FR) Regina Mulhail Basant Sharma (US)

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Directors: Dona1 G'Csnr;el! ErtlMet Cronln Carol Leland Dave Geelac Regini! Muhall

Kyran Johnson Jeanne Bolger Kenneth Slrnme:! <UK> Thiery 3ernoccheeEx (FR: Basant Sharma (US)

_ - _ 11

VAT N" IE G707191E Irish Registration No 472372

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ATTACHMENT C

Schematic of SEMP 3 and SEMP 5 Configuration

Directors: Dor.al O'Conneii Ernnet Cronin Card L e l x d Dave Geelan Regina Mulhall

Kyran Johnson Jeanne 3dger Kermth Simrnen (UK) Th:e;.y Dernoncneaux (FR) Basan: Sharma (US)

____ 12

VAT N" IE 97S7191E Irish Registratior! lrlJ 472372

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I I

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ATTACHMENT D

Copy of Irish Water Section 99E Response

Directors: Dona1 O'Connell Emrnet Cmnin Cam1 Leland Dave Geelan Regina Mulhall

-1- 1 - 1 1 .

14 VAT No IE 9707lQlE

Irish Reglstratlon No 472372

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Ms lir Leacy, Environmental Licensing Programme Office of Environmental Sustainability EPA Headquarters, PO BOK 3000, Johnstown Castle Estate, Co. Wexford Reg No: PO778-02

lrlsh Water PO BDiI 6wO Oublln 1 Ireland

t: +353 1 89 25000 F: +353 1 89 25091 ' -.water.ie

09 July 2018

Dear Ms Leacy,

I refer to €PA correspondence dated 01 February 2018 regarding an application from Janssen Sciences Ireland UC for their facility located at Barnahely, Ringaskiddy, Cork, P43 FA46, for an Industrial Emissions ([E) licence review.

Irish Water have assessed the I€ licence review application PO77842 and are satisfied to recommend to the Agenry the inclusion of the following conditions (overleaf) as part of a revised IE licence far Janssen Sciences Ireland Ut. 'Consent" to discharge trade effluent to the IDA pipeline under Section 99E of the EPA Act 1992, as amended, cannot be granted by Irish Water as the proposed trade effluent discharge is to a private drain/outfall pipe in ownership of IDA Ireland rather than the public sewer.

The management of discharges ta and from the IDA pipeline, includingthe discharge from the Irish Water W P at Shanbally, requires resolution in terms of asset maintenance and regulation of discharges. Pending resolution of these issues, Irkh Water offers the attached recommendation as suggested appropriate conditions to be considered by the EPA.These have regard far protection of assets and environmental quality taking cansideration of combined discharges to the IDA pipeline. It should be noted however that review of individual discharge permissions to the IDA pipeline may be required to accommodate any future determination of appropriate standards for the combined discharge from the IDA outfall pipe.

If you have any further queries, please do not hesitate to contact Irish Water.

Yours; sincerely

Authorised Signatory

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IRISH WATER RESPONSE

GENERAL RECOMMENDED CONDITIONS

1. Other than the trade effluent authorised to be dischnrged under this licence, the

Moniloring and analysis equipment shall ba insklled, operated and maintained as

licensee &nil at no time discharge or cause or permit IO dischnrge trade effluent Dr any other wtter unless authorised by the relevant Water Services Auhority.

2.

I rlsh Water Colvill House 24/26 Talbot Street Dublin 1

Condition to he

Included (Yeflnn)

Yes

YeS

Name of FaciIity: Janssen Sciences Ireland UC

maintenance and calibr&ons 11s set oui bekw and as in accordance with Schedirle C: Control &Monitoring, of this licence,

(i) Sampling and analysis shall be undcnaken by competent staff in accordance with documenled operating procedures.

(ii) Such procedures shall be subject lo P programme ofAndyticol Qunliiy Control using opprapriate control standards with evaluation of test responses.

(iii) Where any analysis is sub-contracted ii shall be ouisourced to a competent laboratory. 4.

5.

I

I

The licensee shall ensure that any trade effluent generated from canteen ncriviries

The licensee shall m;iInim and iinplcrncnr tidehiled programme for maintenance shafl pass through appropriate grease removal equipment prior to discharge.

of a11 plant and equipment bnsed on Lhe instnrctions issued by the manufilcturerlsupplier or installer of the equipment or a5 ohenvise approved in writing by the relevant Water Services Authority

6. A summary report of volumes OF trade effluent and oher mntter discharged t along

Reg. No: PO77842

Yes

Yes

Yes

Location Address: Barnahely, Ringaskiddy, Curk, P43 FA46

necessary. so thnl all; monitoring, accurately reflects the emissioddischarge. 3. The licensee shall carry out such sampling, analyses, measurements, examinations, I YeS

No

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9.- Silt Traps and at ~eparators The Licensee shall, within six mollthE of dnte of grant olthls licence, install aad maintain silt vaps and oil separators at the hif i ty:

(i) Silt traps to efwce that all storm water discharges. o t k lhnn h m roofs, From rhe ki l i ty

(ii) An oil scparruor cm Ihe storm wpler discharge rrmn yard weas. The separatar sMl be I I Class I Class I1 full relentionlby-pass scpantor, <-A b select as

(iii) The silt lraps tlnd separator shall be in accordancc with 15. EN-858-2: 2003

IO. The licensee MI ~onclude an end user agreement wilh h e relevant Wmr Services

rhrough a silr amp in advance of dmhargg;

appmpriato>

Authority. I I . In he event of any incident which ~elatcs to discharges u1 h e IDA pipbline having

tnken place, he likensee sMI d r y Irish Wnw, in h e manner IIS prescrihd by fish Water, as sM)n as practicable &r such an incident.

12. No altcmlion to, or reconsuuction in rcspcct of, the dvity, or any part thcao6 that wodd, or is likely to, m l t in

ti} a mierid change or increase in: the nature or quantity of any emission; h e abotemenhtmeni ur recovery systrms;

the fue4 raw rnmrhki, inarmedkcs, products M wasm gmorated.

. . tklk mg of processes to be cmicd ou1;

OT (ii) any changes in: ’ site mnnagemnt. infmtruclure or cunlrol with adverse cnvironmrtal

significance; shall bc cprried out or commenced withoul prior notice tu. and without lhc approval or, h a d o r &e relevant Wnter Services Authority .s a p d a h&

End Uscr Agreemat definition proposed lo be included in thc Glossmy of Terms for the I E W a s t e Liccnrrrs:

YeS

YES

Y4?S

End Uscr Agreement: “An agrccmcni berwecn the licensee and the &van1 Warn Scrviccs Authority which provides For thc contractual condirions tiad wmngernenls relating ta thc ncccplnncc of, a d o r m n t by, lhe relevnnr Water Services Authority of the Licensee’s trade eMwnt and wastervater.”

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Em’rsrkn Point Reference MO.: SU

Emission to (Pipeline dsc&&onJ: IDA pipehe located dawnstream of Irish Water‘s Omxihaven- Carrigaline-Ringaskiddy WWrP which outfalk to Dognase Bank, Cork Harbour.

Volume dltade effluent emfttedr Maximum in any OM day: Maximm in any hour:

6-9 pH Unlts

Ternrreratun 3Q°C _ _ .

1 O N

Note L Volume of trade effluent discharge to increase from BM) m3/day ta 1200 m3/day from 30th May 2920.

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EPA Export 19-10-2018:03:55:18

Frequency of Monitoring Process Effluent to IDA pipeline

Emission Point Reference No.: Schedule C

SE1

Flow Continuous On line flow meter with recorder

Tern peat ure Continuous On line ternwemure smbe -

PH Continuous On line pH probe

Biochemical Oxygen Demand Monthly Standard Method

Chemical Oxygen Demand Weekly Standard Method

Suspended Solids Weekly Standard Method

Total Phosphorus [as Pj Quarterly Standard Method

Total Nitrogen (as N) Monthly Standard Method

I ChlorIde Quarterly Standard Method

, Sulphates Quarterly Standard Method r

Oils, Fats and Greases Monthly Standard Method

Toxicity Annually Standard Method

Standard Method

Note 1. All sampler excluding those for pH and tempeature shall be collected Q~I a 24 hour flow proportional composite sampling basis.

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EPA Export 19-10-2018:03:55:18

Control of Em'kiolls to IDA pipellhe

Effluent Transfer Suspended SolW (primary)

Effluent Balandqg

1 I 1 control Parameter Allonbring Key Equipment 1

Pumps Daily ufe Pumps Daily Agitator

Solid remwal pumps Skimmed solids pump -

Daily Agitator Feed-fomrd pump

Sigmed on behalf1

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EPA Export 19-10-2018:03:55:18

Janssen Sciences Ireland UC

Registered address: Eastgate Village, Eastgate, Little Island, Co. Cork, lreland Manufacturing slte address: Barnahely, Ringaskiddy, Co. Cork, Ireland +353 21 497 3000 kl +353 21 497 3030 hx

wwwjanssen. le

Darren McCormack Portfolio Executive Strategic Property Division IDA Ireland Athlone Elusiness Technology Park Dublin Road Athlone

1'' August 2018

Re: Janssen Sciences Ireland UC IE Licence Review Application

Dear Darren,

Further to our recent phone call and email dated 26* July I can confirm that Janssen Sciences will comply alJ the conditions and requirements set by Irish Water as per the attached in relation to Janssen Sciences 1E Licence Review Application.

As discussed, I'd be grateful if the IDA could now grant consent to Janssen Sciences for the proposed discharge to the IDA sewer,

If you have any further queries please don't hesitate to contact me.

Yours sincerely,

Pat Fitzgerald' ' E H 5 U Lead lanssen Sciences Ireland UC

Directors: Dona! O'Cannell Emmet Cronln Cam1 Land Dave Geebn Regina Mulhall

Kyran Johnson kanne Bolger Kenneth Slrnmen (UK) Thierry Demoncheaux (FR) Basant S h a m (US)

VAT Ro I€ 9707191E Irish RegWatlon W 472372

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EPA Export 19-10-2018:03:55:18

Mr. Pat Fitzgerald, EHS&S Lead Janssen Supply Chain Ireland Janssen Pharmaceutical Sciences Ireland, Liffle Island Industrial Estate, Liffle Island, Co. Cork. T45 P663

ATWLOHE BUSIIYESS L TECHNOLOGY PARK CAPPtCKT LE DUGLIM ROAD LTWLUAE $0. W E S T Y E W IIEUNO

F A X ! W O 1 CJ~i :50 rC'EGSrTE ww.idaireland.com

?EL {')OB) 5 1 7 t m

Janssen Sciences Ireland, Barnahely, Ringaskiddy CO Cork. P43 FA46

2nd August 20 18

Re: Janssen Pharmaceutical Sciences - Process Effluent Discharge Licence

Dear Pat,

IDA confirms that the foul sewer network in IDA lands in Barnahely, Ringaskiddy, CO Cork is currently in the ownership of IDA Ireland.

On review of the correspondence that you have issued to IDA Ireland, namely an email dated 24' July 201 8 with a letter from Irish Water and Janssen requesting IDA Irelands consent to an amendment of Janssen process effluent discharge levels.

IDA Ireland understands that Irish Water would be satisfied to recommend to the EPA 'consent' subject to a number of conditions (letter attached for reference). Janssen Sciences has provided a letter dated 1'' August 2018 (letter attached for reference) confirming that Janssen Sciences will comply with all the conditions and requirements set out by Irish Water in relation to the Janssen Sciences E Licence Review Application. On this basis, IDA Ireland hereby gives its consent for the proposed discharge to the IDA sewer.

Notwithstanding the fmgoing IDA does not warrant that the above information is accurate or otherwise and in this regard IDA Ireland does not accept any responsibility for the information submitted by Janssen Sciences.

Further you will note that it is incumbent upon Janssen Sciences to satisfy itseIf as to required P l m i n g Permission(s) / Licences or otherwise in relation to discharge into the sewer network.

IDA also note; Failure to comply with the Irish Water Licence requirements and conditions will render the IDA consent granted above null and void.

Yours sincerely

Lh, -CL&..& Darren McCormack fortfolio Executive IDA Property Division

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EPA Export 19-10-2018:03:55:18