File: IE0310791-LET-0004 Administrative Officer Office of ... ·...

IE0310791-LET-0004_1_01_FINAL_LETTER_B.DOC

Template 162.TP.XX, Issue X, 15.07.2012

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The project delivery specialists

Saudi Arabia Singapore Slovakia Turkey UK USA

International Office Network

Belgium China Czech Republic India Ireland Poland Russia

+353 1 404 0700 +353 1 459 9785 [email protected] www.pmgroup-global.com

Project Management Limited t/a PM Group, is a private company limited by 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, S Kelly, M Lynam, P McGrath, L O’Mahony, A Schouten (British), M Shelly, E Tarrant, L Westman Secretary J Sheehan Template Ref: 162.TP.15

PM Group

Killakee House Belgard Square Dublin 24 Ireland

162.TP.15, Issue 4, 14/01/2013

File: IE0310791-LET-0004 5 April 2013 Ms Noeleen Keavey Administrative Officer Office of Climate, Licensing & Resource Use Environmental Protection Agency (EPA) PO Box 3000 Johnstown Castle Estate Co. Wexford

Re: Article 10 Response to Request for Information in

relation Cook Ireland Integrated Pollution Prevention and Control Licence Application (Reg. No.: P0973-01)

Dear Ms Keavey, The following are the responses to the requests for further information issued to Cook Ireland Limited on 11 February 2013 in relation to the Integrated Pollution Prevention and Control (IPPC) Licence application. Request 1 Clarify the details in the application form regarding the discharge to sewer i.e. quantity of the discharge in Table E.3(i) as it relates to your single media licence and the statement in the application form that only 3m3/day will be discharged. Resubmit the relevant tables where necessary. The primary load to sewer at the Cook facility can be attributed to the site’s sanitary and canteen waste water produced from toilets, sinks, dishwasher etc. (ca. 60m3/day, based on historical monitoring data). However, based on a theoretical assessment using British Water Flows and Loads, sanitary discharge to sewer has the potential for volumetric flow of 100m3/day. The total current process effluent contribution is ca. 10m3/day. In line with the site expansion, it is expected that this contribution will increase to ca. 12m3/day. Process effluent primarily consists of product and equipment rinse water containing trace amounts of organic compounds. Table E.3 (i)

Emission Point:

Emission Point Ref. No: SE-1

Location of connection to sewer: Located in the South East of the site

Grid Ref. (12 digit, 6E,6N): 162889E, 158383N

Name of sewage undertaker: Limerick County Council

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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, including

daily or seasonal variations (start-up /shutdown to be included):

Periods of Emission (avg) 60 min/h 17 h/d1y 252 day/y(Note 1)

Note 1: The site operates five days a week (Monday to Friday) on a double shift basis operating between 07:30 – 17:00, with reduced shift work up to 00:15. The site operates all year round with the exception of Christmas and public holidays. Request 2 Clarify if the monitoring point for discharge to sewer is separated from sanitary effluent and if not then submit details of how monitoring for trade effluent is to be carried out. Resubmit the relevant tables where necessary. There is currently one licensed emission point (SE1) discharging to sewer at the Cook facility. The site’s process and sanitary/foul effluent discharges via discharge point SE-1 located to the south east of the site, into the National Technology Park’s foul sewerage system. Effluent is then treated at Castletroy Wastewater Treatment Plant (WWTP) operated by 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 current process effluent contribution is approximately 10m3/day. However, in line with site expansion, it is expected that this contribution will increase to 12m3/day. Process effluent primarily consists of product and equipment rinse water containing possible trace amounts of organic compounds. A review is currently taking place to determine if it is possible to monitor process effluent only and at a single monitoring point. The results of this review will be provided to the EPA as soon as possible. The outcome of this review will also be reflected in an updated Non-Technical Summary. Request 3 Submit the results of monitoring of the discharge to sewer for 2012 as per the WPA Licence Reference S.79 or clarify any agreements with Water Services Authority as regards the submission of results. All monitoring results for SE-1 for 2012 are contained in Attachment 1. All results comply with the trade effluent discharge licence limits as agreed with Limerick County Council and limits proposed as part of the IPPC licence application.

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Request 4 Supply details to enable the Agency to complete the assessment of ‘Fit and Proper Person’ as per Section L.5 of the application form particularly as it relates to financial commitments/liabilities. Since 1963, Cook Group companies have been among the leaders in developing healthcare devices that have improved lives around the world. The Cook Group has grown into a global entity of ca. 42 companies employing more than 10,000 people with manufacturing, sales, logistics and administrative facilities across the United States, Europe and Asia. The 2012 annual global revenue for the company was approximately $2 billion. This demonstrates that the Cook Group will be in a position to meet any financial commitments or liabilities that may have been or will be entered into or incurred in carrying on the activity to which the application relates or in consequence of ceasing to carry out that activity. As outlined in the IPPC licence application, Cook Ireland Ltd. will prepare a costed Residual Management Plan (RMS) and Environmental Liabilities Risk Assessment (ELRA) which will be subject to the agreement of the EPA. These studies will determine the exact costs associated with foreseen e.g. decommissioning and unforeseen e.g. accidents environmental liabilities. The Cook Group commits to a parent company guarantee to cover any possible ELRA & RMP related costs. It is understood that the current Environmental Liability Risk Assessment, Residuals Management Plans and Financial Provision Guidance document (2006) is being reviewed and will be published within the next two to three months. It is proposed that the preparation of the site’s ELRA and RMP aligns with this guidance and associated recommendations with regard to financial provisions. Request 5 Supply details of Solvent A. If there are details that you consider are not suitable for public files for commercial reasons you should review the relevant section of the Application form guidance and contact the inspector below as regards the submission of ‘confidential information’. Please see enclosed supplementary confidential information (IE0310791-MEM-0002) in relation to the details of Solvent A. This is not attached or appended to this letter and is treated as a separate submission. An updated ‘Non-Technical Summary’ is provided in Attachment 2.

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I hope the above provides all information required to complete the assessment of the IPPC licence application. If however you have any questions please do not hesitate 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 electronic searchable PDF format on CD-ROM have been provided. Yours sincerely On behalf of Cook Ireland Ltd

_________________________ Mags Dalton EHS Manager PM Group cc. Mr James Dempsey, Cook Ireland Ltd. Dr Colm Benson, Cook Ireland Ltd.

Ms Norma McCormack, Cook Ireland Ltd. Mr Michael McDonald, PM Group

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mailto:[email protected]

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Attachment 1 Monitoring Results 2012 – SE-1

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Registered Office: VAT No: Tel: 01-6275656 Unit D1 9672901T www.emeraldenvironmental.ie

M4 Business Park CN: 449199 [email protected] Celbridge, Co. Kildare

ISF048(B) – Test Report Issue: A Issue Date: 03/10/11 Authorised By: Raymond Murphy

Customer Name: Norma McCormack Date Sampled: 29/03/2012

Company Name: Cook Medical Date Received: 29/03/2012

Company Address: O Halloran Road Date Analysed: 29/03/2012

National Technology

Park

Co Limerick Sample Location: Plassey – Manhole-SE1

Sample Type: Effluent

Purchase Order No: N/A Grab/Composite: Grab

Sample ID: E0159 Page: 1 of 1

TEST REPORT

Parameter Result Units Method

BOD 362 mg/l SOP001

COD 719 mg/l SOP002

Suspended Solids 269 mg/l SOP003

pH 7.60 pH units SOP004

Temperature 13.0 0 Celsius SOP012

Fats, Oils, Grease <10 mg/l Sub-C

Comments: None

Signed: Date: 16/04/2012

Raymond Murphy – Director

The above results relate only to the sample(s) tested

This report shall not be reproduced unless all data is included and by agreement with Emerald Environmental Services.

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ISF048(B) – Test Report

Issue: B

Issue Date: 03/10/11

Authorised By: Raymond Murphy

Customer Name: Mags Dalton Date Sampled: 07/06/2012

Company Name: PMGroup Global Date Received: 09/06/2012

Company Address: Lough Mahon Bus Park Date Analysed: 09/06/2012

Blackrock

Co Cork Sample Location: Cook Medical Plassey

Sample Type: Trade Effluent

Purchase Order No: N/A Grab/Composite: Composite


TEST REPORT

Parameter Result Units Method BOD 211.5 mg/l O2 SOP001

COD 512 mg/l O2 SOP002



Temperature 14.0 ° Celsius SOP012

Fats, Oils, Grease 14 mg/l Sub-C

Comments: None


Raymond Murphy – Quality Manager



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ISF048(B) – Test Report Issue: B Issue Date: 03/10/11 Authorised By: Raymond Murphy



Company Address: National Tech Park Date Analysed: 01/10/2012

Plassey

Limerick Sample Location: Effluent SE1

Sample Type: Effluent



TEST REPORT


BOD 214.3 mg/l O2 SOP001




Temperature 15 0Celsius SOP012

Fats Oils and Grease <1 mg/l Sub-C

Comments: None





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ISF048(B) – Test Report Issue: B Issue Date: 03/10/11 Authorised By: Raymond Murphy



Company Address: O Halloran Road Date Analysed: 04/01/2013

Plassey

Limerick Sample Location: Plassey

Sample Type: Trade Effluent


Sample ID: F0012 Page: 1 of 1

TEST REPORT


BOD 200.3 mg/l O2 SOP001




Temp 15.8 0 Celsius SOP012

Fats Oil and Grease <1 mg/l Sub-C

Comments: None





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Attachment 2 Updated Non-Technical Summary (NTS)

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A.1 Non-Technical Summary A.1.1 Introduction Based in the National Technology Park in Limerick since 1996, Cook Medical in Ireland employs nearly 720 people across a range of divisions from research and development of endoscopy, 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. Cook Ireland is also home to the European shared services centre providing tenders and customer and clinical support to hospitals and physicians across the continent. Established initially as a production and distribution centre, Cook Ireland quickly developed to encompass the R&D and manufacturing of urology and gastroenterology products. In 2004 the Cook Ireland plant expanded to create a European shared service centre while in 2009 it was chosen as the global manufacturing base for Zilver Coated Stent. R&D facilities have continued to grow to include peripheral intervention devices and today 10% of Cook Ireland’s sales come from products designed in Limerick. Cook Medical’s European shared service centre in Limerick supports sales activities in Europe. 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 based employees. There is over 100 dedicated customer service and tenders staff working in 13 languages to support hospitals and physicians across 16 countries in Europe. Languages include: French, Italian, German, Spanish, Dutch, Flemish, Norwegian, Polish and Hungarian. Headquartered in Bloomington, Indiana, Cook Medical is the largest privately-owned medical devices company in the world with 15 facilities located throughout the US, Europe and Asia employing more than 10,000 people. It was one of the first companies to pioneer many of the devices now commonly used worldwide to perform minimally invasive medical procedures. Since 1963, improving patient outcomes has been its focus. It has worked with physicians to develop products and now offers 15,000 products across a wide range of hospital departments including cardiology, urology, endoscopy, radiology and vascular surgery, to name a few. In line with product demand Cook must continue to grow and expand its Limerick facility in order to continue to meet the needs and requirements of its customers. One such area of growth is in response to the growing demand for the Cook Zilver coated stent. It is the demand for this product that has now resulted in the Cook facility coming under Class 12.2.2 of the First Schedule of the Protection of the Environment Act Acts 1992-2011, namely: Class 12.2.2: The manufacture or use of coating materials in processes with a capacity to make or use

at least 10 tonnes per year of organic solvents,

Planning for the manufacturing of this product has been granted under the sites existing planning permissions. A.1.2 Management of the Facility Technical Competence & Site Management The Managing Director of Cook Ireland has overall responsibility for the operation of the proposed facility. The facility is operated by a dedicated management team. The staff of the facility are technically experienced and qualified in the areas of operations, manufacturing, engineering, environmental, health and safety, finance, administration, human resources and maintenance. Environmental Management System An Environmental Management System (EMS) will be developed for the management of the environmental aspects and impacts of the facility. The EMS will address the provision of all resources, human and otherwise, necessary to ensure control and continuous improvement in the environmental management of the facility. The EMS will be subject to an annual review for continuing suitability and effectiveness by a senior manager.

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Hours of Operation The site operates five days a week (Monday to Friday) on a double shift basis operating between 07:30 – 17:00, with reduced shift work up to 00:15. The site operates all year round with the exception of Christmas and public holidays. A.1.3 Production Process Cook Ireland manufactures and assembles minimally-invasive medical devices for use in the healthcare industry. The primary function of the Cook facility is the assembly of externally supplied product components into a final product. Product assembly and manufacturing consists of assembly and manufacturing activities located in clean rooms, also known as Clean Manufacturing Areas (CMAs). Given the large number of products developed onsite, process units are divided into the general processes onsite and into the main business product families associated with facility, namely: 1. Incoming Inspection and Storage 2. Manufacturing, Manual Assembly, Labelling and Inspection

Zilver Coated Stent Zilver Bare Metal Stent (BMS) Evolution Electro Ultrasound Plastic Stents Other

3. Product Sterilisation and Distribution 4. Utilities 5. Laboratory Activities Incoming Inspection and Storage is where product components, chemicals and other raw materials 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) and G.1 (ii). Manufacturing, manual assembly, labelling and inspection activities are conducted in the facilities CMAs. Product Sterilisation and Distribution is where assembled product is shipped off site for product 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 hot

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

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

purification. 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 product decontamination. All laboratory work is performed to current Good Laboratory Practices and quality systems. All chemicals utilised in the labs are stored in local chemical safety cabinets and fume cupboard flammable storage cabinets within the various labs. Waste chemicals are disposed 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 construction project and this will be dedicated solely to R&D activities. A.1.4 Energy Efficiency All equipment onsite is rated and serviced as per the requirements of the site’s maintenance regime. The implementation of an Environmental Management Programme as discussed in Section C of this Application will help to identify energy saving projects and help to improve the overall energy efficiency of the facility. An energy audit in accordance with the EPA Guidance document on Energy Audits will be carried out within one year of IPPC licence being granted. A.1.5 Chemical Storage There are a number of chemicals and hazardous storage areas at the Cook facility as detailed in Section H of this Application. All areas have adequate secondary containment and are designed and maintained to meet the 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 line with current best practice. Where access permits and in accordance with the ‘EPA IPC Guidance Notes on Storage and Transfer of Materials for Scheduled Activities, 2004’ requirements, underground pipelines that carry process waste liquids shall be inspected by CCTV cameras to ensure integrity. This will be carried out within one year of the licence being granted and in accordance with the ‘EPA IPC Guidance Notes on Storage and Transfer of Materials for Scheduled Activities, 2004’ thereafter. A.1.6 Waste Management Non-Hazardous Waste Management Pallets, paper, cardboard and plastic are segregated and collected for recycling by licensed waste contractors. General non-hazardous waste is compacted on-site and collected for disposal by a licensed waste disposal contractor. All documentation is retained on-site in accordance with legislative requirements. Hazardous Waste Management All hazardous wastes are labelled and covered and then stored in contained areas onsite before being collected and disposed of by licensed hazardous waste contractors. This includes laboratory wastes, empty hazardous containers, waste solvent etc. Where possible,

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these are sent for recycling or recovery. All documentation is retained on-site in accordance with legislative requirements. A.1.7 Emissions to Air Boiler emissions: There are 6 No. gas fired boilers onsite with another one expected to be installed by the end of 2013. The boilers supply process hot water to Phases 1, 2 and 3 of the facility. 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 the north of the site. The boilers currently operate at an efficiency in excess of 90%. To ensure maximum efficiency 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 / fugitive air emissions as outlined in Section E of this application. As discussed in Section I of this Application the UK H1 guidance document was used to assess the impact of air emissions from site. All calculated VOC and particulate process contributions were below their respective environmental assessment levels (EAL’s) and air quality standards (AQS). It is estimated that the site’s fugitive emissions for 2011 were approximately 14% of the facility’s solvent consumption. This demonstrates the sites current compliance with the applicable BAT limit of 20%. Air emissions from the Cook facility do not have any adverse impact on local air quality. A.1.8 Emissions to Surface Water The Cook site has a network of storm water drains which collect surface/rainwater from the paved areas and roof areas of the site. These storm waters drain by gravity to the National Technology Parks storm water drainage system via two surface water emission points (SW-1 and SW-2) as shown in Attachment E.2. Prior to discharge all surface water passes through class 1 bypass petrol interceptors (x3) to ensure that only uncontaminated water discharges to the National Technology’s Parks storm water drainage system. Given the current and expected containment measures onsite, the risk of contaminants reaching the receiving water body is considered low. A.1.9 Emissions to Sewer There is currently one licensed emission point (SE1) discharging to sewer at the Cook facility. The site’s process and sanitary/foul effluent discharges via discharge point SE-1 located to the south east of the site, into the National Technology Park’s foul sewerage system. Effluent is then treated at Castletroy Wastewater Treatment Plant (WWTP) operated by 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 current process effluent contribution is approximately 10m3/day. However, in line with site expansion, it is expected that this contribution will increase to 12m3/day. Process effluent primarily consists of product and equipment rinse water containing possible trace amounts of solvent. A review is currently taking place to determine if it is possible to monitor process effluent only. The results of this review will be provided to the EPA as soon as possible. All process emissions are small in quantity and given their dilute nature no adverse impact on the environment or the Castletroy WWTP is expected.

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A.1.10 Noise Emissions The ambient noise monitoring results (inclusive of onsite noise emissions) indicate that existing noise levels at the noise sensitive locations are low with the exception of NSL2 which can be attributed to heavy traffic on the local road network. The plant associated with the planned increase in site production will not have any adverse effect on existing noise levels at the nearest noise sensitive locations. Tonal noise analysis of the ambient noise environment (inclusive of current site emissions) indicates that there is currently no tonal noise detectable at any of the NSLs . The design and maintenance of the future noise sources at the facility will ensure that tonal noise will not arise at the NSLs due to the facility operation. Therefore, in accordance with the EPA guidance Note NG4, noise attributable solely to onsite activities 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 on ambient noise levels at the nearest noise sensitive locations. A.1.11 Environmental Considerations and BAT The proposed development has taken into account the Best Available Techniques Guidance Note for Solvent Use in Coating, Cleaning and Degreasing. A.1.12 Accident Prevention and Emergency Response The prevention of accidental emissions and spills is facilitated by good design of equipment and the management of operations at the Cook site in the following areas: Containment: All areas have adequate secondary containment. As previously discussed

in Attachment H Training: Cook Ireland’s training programme is designed to ensure that appropriate

training requirements are identified and provided to all personnel for the satisfactory performance of their duties. Emergency response training will be further enhanced through the implementation of a site EMS.

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

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

A.1.13 Remediation, Decommissioning, Restoration and Aftercare Cook will prepare and submit a Closure Plan (CP) and ELRA in accordance with the EPA guidance on Environmental Liability Risk Assessment, Residuals Management Plans and Financial Provision within 12 months of the licence being granted. A.1.14 Statutory Requirements This application and the proposed development has taken due regard to the statutory requirements outlined in this section of the application. The proposed facility will comply with or not contravene the statutory requirements, as outlined in Section L of this application. A.1.15 Declaration of Application This application includes the formal, signed declaration of Cook Ireland Limited for the making of an application to the EPA for an Integrated Pollution Prevention and Control licence.

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