Re:Article 10 Response to Request for Information in ... · This letter is submitted as a follow-up to the Article 10 Response to Request for Information (RFI) in relation Cook Ireland’s

DOCUMENT1

Template 162.TP.XX, Issue X, 15.07.2012

162.TP.15, Issue 6, 08/05/2013

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Project Management Limitedt/a PM Group, is a private company limitedby shares, registered in Ireland.Company Registration No. 043789.Registered Office: Killakee House,Belgard Square, Dublin 24, Ireland.

Directors D Flinter (Chairman), D Murphy (CEO),B Gallagher, H Keelan, S Kelly, M Lynam,P McGrath, L O’Mahony, A Schouten (British),M Shelly, L Westman

Secretary J SheehanTemplate Ref: 162.TP.15

PM GroupKillakee HouseBelgard SquareDublin 24Ireland

File: IE0310791-LET-0005

14 June 2013

Ms Noeleen KeaveyAdministrative OfficerOffice of Climate, Licensing & Resource UseEnvironmental Protection Agency (EPA)PO Box 3000Johnstown Castle EstateCo. Wexford

Re:Article 10 Response to Request for Information inrelation to Cook Ireland’s Integrated PollutionPrevention and Control Licence Application (Reg. No.:P0973-01) (Part 2)

Dear Ms Keavey,

This letter is submitted as a follow-up to the Article 10 Response to Request forInformation (RFI) in relation Cook Ireland’s Integrated Pollution Prevention andControl Licence Application (Reg. No.: P0973-01) which was submitted on 5 April2013. It also contains a response to a query issued by Maire O’Connor on 30 May2013.

The response referenced above detailed a response to a number of queriesoutlined in the EPA’s RFI, dated 11 February 2013. However, there is one querystill outstanding as follows:

Clarify if the monitoring point for discharge to sewer is separated from sanitaryeffluent and if not then submit details of how monitoring for trade effluent is to becarried out. Resubmit the relevant tables where necessary.

A review was taking place at the time of the response submission to determine if itis possible to monitor process effluent only and at a single monitoring point.

Following this review, it is proposed to monitor process effluent only at onemonitoring point (an existing monitoring point located in the Phase 3 part of thesite) as illustrated in the drawing provided in Attachment 1 (IE0310661-30-DR-0010Rev. B). It is proposed to name this monitoring point SE-3. All process effluent fromthe site will be pumped to this location as detailed in the drawing to allow it to bemonitored separately to sanitary effluent. Therefore, it is proposed to demotemonitoring at SE-1 to Oils, Fats and Greases (OFG) only. This monitoring willcapture the key characteristics of the canteen effluent, not captured at SE-3.

There are on-going discussions currently with Limerick County Council (Q1 non-compliances) and they are aware of the proposed monitoring changes.

Proposed details of monitoring points SE-1 and SE-3 are given in Tables E.3 (i)and F.2 (i) for each monitoring point below.

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Table E.3 (i)

Emission Point:

Emission Point Ref. No: SE-1

Location of connection to sewer: Located north east of building.

Grid Ref. (12 digit, 6E,6N): 162865E, 158320N

Name of sewage undertaker: Limerick County Council

Emission Details:

(i) Volume to be emitted

Normal/day 72m3 Maximum/day 100m3

Maximum rate/hour 30m3/hour

(ii) Period or periods during which emissions are made, or are to be made, includingdaily or seasonal variations (start-up /shutdown to be included):

Periods of Emission (avg) 60 min/h 17 h/day 252 day/yr (Note 1)

Note 1: The site currently operates five days a week (Monday to Friday) on a double shift basisoperating between 07:30 – 17:00, with reduced shift work up to 00:15. The site operates all year roundwith the exception of Christmas and public holidays.

Table F.2 (i)

Emission Point Reference No.: SE-1

Parameter Monitoringfrequency

Accessibilityof SamplingPoints

Samplingmethod

Analysismethod/technique

OFG (mg/l) Quarterly Car park -manhole lidneeds to beremoved

Grab sample StandardMethod EPAApproved

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Table E.3 (i)

Emission Point:

Emission Point Ref. No: SE-3

Location of connection to sewer: Located in the north west of the building.

Grid Ref. (12 digit, 6E,6N): 162741E, 158383N

Name of sewage undertaker: Limerick County Council

Emission Details:

(i) Volume to be emitted

Normal/day 12m3 Maximum/day 12m3

Maximum rate/hour 2m3/hour

(ii) Period or periods during which emissions are made, or are to be made, includingdaily or seasonal variations (start-up /shutdown to be included):

Periods of Emission (avg) 60 min/hr 17 hr/day 252 day/yr(Note 1)

Note 1: The site currently operates five days a week (Monday to Friday) on a double shift basisoperating between 07:30 – 17:00, with reduced shift work up to 00:15. The site operates all year roundwith the exception of Christmas and public holidays (10 days).

Table F.2 (i)

Emission Point Reference No.: SE-3

Parameter Monitoringfrequency

Accessibilityof SamplingPoints

Samplingmethod

Analysismethod/technique

Flow(m3/day)

Quarterly In Plant room– sump coverneeds to beremoved

Grab sample Flow Meter

COD (mg/l) Quarterly In Plant room– sump coverneeds to beremoved

Grab sample StandardMethod EPAApproved

BOD (mg/l) Quarterly In Plant room– sump coverneeds to beremoved

Grab sample StandardMethod EPAApproved

SS (mg/l) Quarterly In Plant room– sump coverneeds to beremoved

Grab sample StandardMethod EPAApproved

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Parameter Monitoringfrequency

Accessibilityof SamplingPoints

Samplingmethod

Analysismethod/technique

pH Quarterly In Plant room– sump coverneeds to beremoved

Grab sample StandardMethod EPAApproved

Temperature(°C)

Quarterly In Plant room– sump coverneeds to beremoved

Grab sample StandardMethod EPAApproved

In addition, information was requested from Ms Marie O’Connor, EPA in an emaildated 30th May 2013 in relation to likely environmental liabilities and the costsassociated with them.

It is considered that any risks from solvent usage and the associated costs ofremediation are minor. This is based on the following: the small unit-volumes ofsolvent currently used on site, the fact that the planned installation of a bulk solventsupply system is currently on hold, the lack of underground pipes carryingchemicals on site, the fact that six out of the seven boilers on site run on gas andwith the fact that there has been no historical legacy of pollution or polluting events.Therefore, it is our view a parent company guarantee can be considered asacceptable for the purpose of deciding the Final Determination.

An updated ‘Non-Technical Summary’ is provided in Attachment 2.

I hope the above provides all information required to complete the assessment ofthe IPPC licence application. If however you have any questions please do nothesitate to contact me at 01 4040797, 087 7525341 or [email protected].

Please note 1 signed original, 1 copy in hardcopy format and 2 copies in electronicsearchable PDF format on CD-ROM have been provided.

Yours sincerely

On behalf of Cook Ireland Ltd

_________________________Mags DaltonEHS ManagerPM Group

cc. Ms Marie O’Connor, EPAMr James Dempsey, Cook Ireland Ltd.Dr Colm Benson, Cook Ireland Ltd.Mr Michael McDonald, PM Group

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Attachment 1Drawing IE0310661-30-DR-0010 Rev. Billustrating the location of the proposed singlemonitoring point for process effluent (SE-3)and existing sanitary effluent monitoring point(SE-1)

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COOK IRELAND LTD

IRDC REVAMP

EXISTING AND PROPOSED

DRAINAGE DRAWING

IE0310661

IE0310661-30-DR-00101:500

LEGEND

NOTES

N

FORMAL ISSUE

GAS

COMPOUND

EXISTING P1G RAW MATERIALS

EXISTING P1G PACKING

PROPOSED CLEANROOM

SHIPPING

AREA

SHIP TO

STERILISATION

55m ²

EX

IS

TIN

G C

OR

RID

OR

NEW

CORRIDOR

EXISTING CLEANROOM

EXISTING P2G. OPEN PLAN OFFICES

EX

IS

T. P

2G

OF

FIC

E

EX

IS

T. P

2G

OF

FIC

E

EX

IS

T. P

2G

OF

FIC

E

EXIST.

STAIR

EXIST.

LOBBY

EXISTING P2G.

ENTRANCE

LOBBY

EXIST.

LIFT LOBBY

EXIST.

RESTROOM

EXIST.

TEASTN.

LIFT

EXISTING P1G. PRODUCTION

EXIST. P1G OFFICES

EXIST. P1G

OFFICES

EXISTING P1G.

RECEPTION

EXIST.

MAIN

STAIR

EXIST. P1G

OFFICES

EXIST.

STAIR

EXIST. P1G

GOWN UP

EXIST.

FEMALE

WC

EXIST.

MALE

WC

EXISTING P1G CORRIDOR

EXISTING P1G

RAW MATERIALS

RECEIVING

EXIST.

STAIR

EXIST.

BIO-HAZARD

LAB.

EXISTING PLANT ROOM

EXISTING FUTURE PRODUCTION AREA

EXISTING

ENGINEERING

LAB.

EXISTING

ANALYTICAL

LAB.

EXISTING

BOXING &

LABELLING

EXISTING CORRIDOR

EXIST.

STAIR

No. 2

EXISTING LOCKER ROOM

EXISTING

KITCHEN

EXIST.

WASH

EXISTING SERVERY

EXISTING CANTEEN

EXIST.

OFFICE

EXISTING CORRIDOR

EXIST.

FOYER

EX

IS

TIN

G

PR

OD

UC

TIO

N

EXISTING

YARD

E.S.B.

SWITCH

ROOM

TRANSF.

SW

IT

CH

RO

OM

EXIST.

COMPRESSOR

ROOM

EXIST.

BOILER

ROOM

EXISTING

EXISTING

CHILLER

COMPOUND

NEW

LIFT

437m²

13.6m²

CLEANERS

STORE

ENG. WORK

ROOM

53.5m²

27.5m²

6.3m²

FOUL EFFLUENT

DISCHARGE POINT

REF: SE-1

PROCESS EFFLUENT

MONITORING POINT

REF: SE-3

PHASE 1PHASE 3 PHASE 2

162865.310 E

158319.698 N

162741.398 E

158383.096 N

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Attachment 2Updated Non-Technical Summary (NTS)

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A.1 Non-Technical Summary

A.1.1 IntroductionBased in the National Technology Park in Limerick since 1996, Cook Medical in Irelandemploys nearly 720 people across a range of divisions from research and development ofendoscopy, urology and vascular products to the manufacturing of the Zilver Coated Stent,the world’s first drug-eluting stent approved for use in the superficial femoral artery. CookIreland is also home to the European shared services centre providing tenders and customerand clinical support to hospitals and physicians across the continent.

Established initially as a production and distribution centre, Cook Ireland quickly developed toencompass the R&D and manufacturing of urology and gastroenterology products. In 2004the Cook Ireland plant expanded to create a European shared service centre while in 2009 itwas chosen as the global manufacturing base for Zilver Coated Stent. R&D facilities havecontinued to grow to include peripheral intervention devices and today 10% of Cook Ireland’ssales come from products designed in Limerick.

Cook Medical’s European shared service centre in Limerick supports sales activities inEurope. Regulatory affairs, marketing, events and PR, customer service and tenders, finance,HR, and IT functions are all based in Limerick servicing both Irish and European field basedemployees. There is over 100 dedicated customer service and tenders staff working in 13languages to support hospitals and physicians across 16 countries in Europe. Languagesinclude: French, Italian, German, Spanish, Dutch, Flemish, Norwegian, Polish and Hungarian.

Headquartered in Bloomington, Indiana, Cook Medical is the largest privately-owned medicaldevices company in the world with 15 facilities located throughout the US, Europe and Asiaemploying more than 10,000 people. It was one of the first companies to pioneer many of thedevices now commonly used worldwide to perform minimally invasive medical procedures.Since 1963, improving patient outcomes has been its focus. It has worked with physicians todevelop products and now offers 15,000 products across a wide range of hospitaldepartments including cardiology, urology, endoscopy, radiology and vascular surgery, toname a few.

In line with product demand Cook must continue to grow and expand its Limerick facility inorder to continue to meet the needs and requirements of its customers. One such area ofgrowth is in response to the growing demand for the Cook Zilver coated stent. It is thedemand for this product that has now resulted in the Cook facility coming under Class 12.2.2of the First Schedule of the Protection of the EnvironmentAct Acts 1992-2011, namely:

Class 12.2.2: The manufacture or use of coating materials in processes with a capacity to make or useat least 10 tonnes per year of organic solvents,

Planning for the manufacturing of this product has been granted under the site’s existingplanning permissions.

A.1.2 Management of the FacilityTechnical Competence & Site ManagementThe Managing Director of Cook Ireland has overall responsibility for the operation of theproposed facility. The facility is operated by a dedicated management team. The staff of thefacility are technically experienced and qualified in the areas of operations, manufacturing,engineering, environmental, health and safety, finance, administration, human resources andmaintenance.

Environmental Management SystemAn Environmental Management System (EMS) will be developed for the management of theenvironmental aspects and impacts of the facility. The EMS will address the provision of allresources, human and otherwise, necessary to ensure control and continuous improvement inthe environmental management of the facility. The EMS will be subject to an annual review forcontinuing suitability and effectiveness by a senior manager.

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Hours of OperationThe site currently operates five days a week (Monday to Friday) on a double shift basisoperating between 07:30 – 17:00, with reduced shift work up to 00:15. The site operates allyear round with the exception of Christmas and public holidays.

A.1.3 Production ProcessCook Ireland manufactures and assembles minimally-invasive medical devices for use in thehealthcare industry.

The primary function of the Cook facility is the assembly of externally supplied productcomponents into a final product. Product assembly and manufacturing consists of assemblyand manufacturing activities located in clean rooms, also known as Clean ManufacturingAreas (CMAs).

Given the large number of products developed onsite, process units are divided into thegeneral processes onsite and into the main business product families associated with facility,namely:

1. Incoming Inspection and Storage2. Manufacturing, Manual Assembly, Labelling and Inspection

Zilver Coated StentZilver Bare Metal Stent (BMS)EvolutionElectro UltrasoundPlastic StentsOther

3. Product Sterilisation and Distribution4. Utilities5. Laboratory Activities

Incoming Inspection and Storage is where product components, chemicals and other rawmaterials are received, inspected and stored prior to distribution throughout the facility.Details on the principal materials that are used at the facility are given in Tables G.1 (i) andG.1 (ii).

Manufacturing, manual assembly, labelling and inspection activities are conducted in thefacilities CMAs.

Product Sterilisation and Distribution is where assembled product is shipped off site forproduct sterilisation, received and then redistributed as required.

The principal utilities at the Cook facility are as follows:

Energy – Six operational and one proposed duty/standby gas fired boilers provided hotwater throughout the facility.

Nitrogen, compressed air and chilled media are supplied throughout the facility asrequired.

Potable water is supplied via Limerick Co Council mains for further softening andpurification.

Heating, Ventilation and Air Conditioning (HVAC) Building Management Systems (BMS) provides plant control throughout the facility

There are four laboratories on site:

Analytical Laboratory Product Development Laboratory Engineering Laboratory Biohazard Laboratory

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Activities consist of quality assurance, product development, product inspection and productdecontamination. All laboratory work is performed to current Good Laboratory Practices andquality systems. All chemicals utilised in the labs are stored in local chemical safety cabinetsand fume cupboard flammable storage cabinets within the various labs. Waste chemicals aredisposed of as hazardous waste through a licenced waste contractor.

An additional laboratory is scheduled to be built in Phase 2 as part of the current constructionproject and this will be dedicated solely to R&D activities.

A.1.4 Energy EfficiencyAll equipment onsite is rated and serviced as per the requirements of the site’s maintenanceregime. The implementation of an Environmental Management Programme as discussed inSection C of this Application will help to identify energy saving projects and help to improvethe overall energy efficiency of the facility. An energy audit in accordance with the EPAGuidance document on Energy Audits will be carried out within one year of IPPC licencebeing granted.

A.1.5 Chemical StorageThere are a number of chemicals and hazardous storage areas at the Cook facility as detailedin Section H of this Application.

All areas have adequate secondary containment and are designed and maintained to meetthe following:

Storage areas are identified and designated before chemicals are brought on-site. Storage areas are properly labelled to indicate, at a minimum, the type or class of

chemicals in storage and their associated hazards (e.g. flammable, corrosive, toxic, etc.). Hazardous chemicals that are incompatible with other chemicals or materials are

segregated by a physical structure or other appropriate means. Storage areas have appropriate spill control measures and adequate secondary

containment systems in place and staff are trained in their use. A sufficient quantity of suitable spill control equipment is kept in or near chemical storage

areas. Containers holding hazardous chemicals are kept closed during storage, except when it

is necessary to add or remove chemicals. Containers are handled in a manner that will not cause them to leak, spill or be damaged.

Bunds will be tested within one year of grant of licence and every three years thereafter in linewith current best practice. Where access permits and in accordance with the ‘EPA IPCGuidance Notes on Storage and Transfer of Materials for Scheduled Activities, 2004’requirements, underground pipelines that carry process waste liquids shall be inspected byCCTV cameras to ensure integrity. This will be carried out within one year of the licence beinggranted and in accordance with the ‘EPA IPC Guidance Notes on Storage and Transfer ofMaterials for Scheduled Activities, 2004’ thereafter.

A.1.6 Waste ManagementNon-Hazardous Waste ManagementPallets, paper, cardboard and plastic are segregated and collected for recycling by licensedwaste contractors. General non-hazardous waste is compacted on-site and collected fordisposal by a licensed waste disposal contractor. All documentation is retained on-site inaccordance with legislative requirements.

Hazardous Waste ManagementAll hazardous wastes are labelled and covered and then stored in contained areas onsitebefore being collected and disposed of by licensed hazardous waste contractors. Thisincludes laboratory wastes, empty hazardous containers, waste solvent etc. Where possible,these are sent for recycling or recovery. All documentation is retained on-site in accordancewith legislative requirements.

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A.1.7 Emissions to AirBoiler emissions: There are 6 No. gas fired boilers onsite with another one expected to beinstalled by the end of 2013. The boilers supply process hot water to Phases 1, 2 and 3 of thefacility. The site domestic hot water is supplied by 2 No. gas fired domestic hot water heaters.A kerosene fired domestic boiler services and is located in the residential house located to thenorth of the site.

The boilers currently operate at an efficiency in excess of 90%. To ensure maximumefficiency in the operation of the boilers, the following parameters are carefully controlled:

Keeping the air/fuel ratio to the correct ratio to ensure complete combustion; and Meeting the target temperature and pressure of the boiler.

Combustion testing is carried out annually on all production boilers onsite.The site consists of 38 No. minor emission points together with a number of potential / fugitiveair emissions as outlined in Section E of this application.

As discussed in Section I of this Application the UK H1 guidance document was used toassess the impact of air emissions from site. All calculated VOC and particulate processcontributions were below their respective environmental assessment levels (EAL’s) and airquality standards (AQS).

It is estimated that the site’s fugitive emissions for 2011 were approximately 14% of thefacility’s solvent consumption. This demonstrates the sites current compliance with theapplicable BAT limit of 20%. Air emissions from the Cook facility do not have any adverseimpact on local air quality.

A.1.8 Emissions to Surface WaterThe Cook site has a network of storm water drains which collect surface/rainwater from thepaved areas and roof areas of the site. These storm waters drain by gravity to the NationalTechnology Parks storm water drainage system via two surface water emission points (SW-1and SW-2) as shown in Attachment E.2. Prior to discharge all surface water passes throughclass 1 bypass petrol interceptors (x3) to ensure that only uncontaminated water dischargesto the National Technology’s Parks storm water drainage system.

Given the current and expected containment measures onsite, the risk of contaminantsreaching the receiving water body is considered low.

A.1.9 Emissions to SewerThere is currently one licensed emission point (SE-1) discharging to sewer at the Cook facility.

The site’s process and sanitary/foul effluent streams discharge via discharge point SE-1located to the north east of the building, into the National Technology Park’s foul seweragesystem. Effluent is then treated at Castletroy Wastewater Treatment Plant (WWTP) operatedby Limerick County Council before being discharged to the River Shannon.

Effluent from Cook Medical is predominately made up of sanitary waste water (ca. 60m3/day).Sanitary effluent arises from the site’s toilets, washrooms and canteen. The total currentprocess effluent contribution is approximately 10m3/day. In line with site expansion, it isexpected that this contribution will increase to 12m3/day. Process effluent primarily consists ofproduct and equipment rinse water containing possible trace amounts of solvent.

It is now proposed to monitor process effluent only at one monitoring point (SE-3), before itcombines with the site’s sanitary effluent. All process effluent from the site will be pumped tothis location as detailed in the drawing IE0310661-30-DR-0010 Rev. B to allow it to bemonitored.

Since this monitoring point (SE-3) does not capture the site’s canteen effluent stream, it isproposed to only monitor Oils, Fats and Greases (OFGs) at the site’s current licensedmonitoring point (SE-1).

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A.1.10 Noise EmissionsThe ambient noise monitoring results (inclusive of onsite noise emissions) indicate thatexisting noise levels at the noise sensitive locations are low with the exception of NSL2 whichcan be attributed to heavy traffic on the local road network.

The plant associated with the planned increase in site production will not have any adverseeffect on existing noise levels at the nearest noise sensitive locations. Tonal noise analysis ofthe ambient noise environment (inclusive of current site emissions) indicates that there iscurrently no tonal noise detectable at any of the NSLs. The design and maintenance of thefuture noise sources at the facility will ensure that tonal noise will not arise at the NSLs due tothe facility operation.

Therefore, in accordance with the EPA guidance Note NG4, noise attributable solely to onsiteactivities shall not exceed the following criteria:

Daytime (07:00 to 19:00hrs) – 55dB LAr,T; Evening time (19:00 to 23:00hrs) – 50dB LAr,T; Night time (23:00 to 07:00hrs) – 45dB LAeq,T.

It can be concluded that the development does not have any significant adverse impact onambient noise levels at the nearest noise sensitive locations.

A.1.11 Environmental Considerations and BATThe proposed development has taken into account the Best Available Techniques GuidanceNote for Solvent Use in Coating, Cleaning and Degreasing.

A.1.12 Accident Prevention and Emergency ResponseThe prevention of accidental emissions and spills is facilitated by good design of equipmentand the management of operations at the Cook site in the following areas:

Containment: All areas have adequate secondary containment. As previously discussedin Attachment H

Training: Cook Ireland’s training programme is designed to ensure that appropriatetraining requirements are identified and provided to all personnel for the satisfactoryperformance of their duties. Emergency response training will be further enhancedthrough the implementation of a site EMS.

Procedural Control: The implementation of the site EMS procedures will cover both theavoidance of a loss of control, the actions to restore control, to minimise any potentialenvironmental impacts.

Emergency Response: The current Emergency Response Procedure focuses primarilyon Life Safety. A fire detection and automatic sprinkler system is installed throughout thefacility and there is an electronic accounting system for determining what employees areon site at any one time. The procedure however will be further developed within 6months of the licence being granted, to additionally address potential environmentalissues.

A.1.13 Remediation, Decommissioning, Restoration and AftercareCook will prepare and submit a Closure Restoration Aftercare Management Plan (CRAMP)and Environmental Liabilities Risk Assessment (ELRA) in accordance with the EPA guidanceon Environmental Liability Risk Assessment, Residuals Management Plans and FinancialProvision within 12 months of the licence being granted.

A.1.14 Statutory RequirementsThis application and the proposed development has taken due regard to the statutoryrequirements outlined in this section of the application. The proposed facility will comply withand not contravene the statutory requirements, as outlined in Section L of this application.

A.1.15 Declaration of ApplicationThis application includes the formal, signed declaration of Cook Ireland Limited for the makingof an application to the EPA for an Integrated Pollution Prevention and Control licence.

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