Integrated Pollution Prevention & Control Licence Review

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1 Integrated Pollution Prevention & Control Licence Review Johnson & Johnson Vision Care Ireland Attachment A1

2 Non Technical Summary This is a summary, in non-technical language, of the information provided in the IPPC Licence Application. A.1 General Vistakon Ireland Ltd develops, manufactures and distributes a range of soft, disposable contact lenses, including the ACUVUE Disposal Contact Lens, the SUREVUE Daily Wear Contact Lens and the 1-DAY ACUVUE Disposable Contact Lens recommended for daily replacement. Vistakon lenses are provided in compact cardboard multi-pack containers. Each lens is immersed in a sterilised, buffered, saline solution and enclosed in a separate thermoplastic material blister package that will maintain the lens in a sterile condition for up to five years. The vast majority of Vistakon lens packaging is recyclable. Vistakon was founded in Buffalo, New York, U.S.A, in 1959 as Frontier Contact Lens Inc and relocated to Jacksonville Florida in In 1981, Johnson & Johnson acquired Frontier Contact Lens Inc, and in June 1982, the name was changed to Vistakon. Up until 1994, all lenses were manufactured at the company's Headquarters in Jacksonville, Florida. Vistakon decided to locate in Ireland because of the favourable regime towards manufacturing investment and the availability of skilled labour. A major factor in their decision to locate in Limerick was the availability of a large greenfield site in a fully serviced high technology industrial park within easy travelling distance of Shannon Airport. See Site Location and Site Boundary Drawings in Attachment B.2. Vistakon Ireland's parent company, Johnson & Johnson, has many other manufacturing facilities throughout Ireland including; Alza, Janssen and Centocor. These sites are IPPC licensed. A.2 Background to the Development In 1994, Vistakon Ireland obtained planning permission for the construction of the first phase of the existing buildings, the manufacturing process and ancillary facilities. The second production block and ancillary services were installed in , along with ancillary support areas (See Site Layout Drawing 2 in Attachment B.2). Until 2007, the production of the disposable contact lenses included a water-based washing step. During 2007 and 2008, 20% of production line (6 lines)were converted to include a solvent based washing step using Iso-propyl Alcohol (IPA)/water mixture in addition to the existing de-ionised water process. During 2009 it is proposed that a further 2 exisitng lines will use a Propylene Glycol (PG) based solvent washing stage. The production changes in 2007 required the use of IPA as a cleaning agent in quantities that exceed thresholds set for a Class Activity in the EPA Act and hence the site was required to operate under an IPPC licence. The original licence application was received by the Agency on February 1, 2007 and the site was granted an Integrated Pollution Prevention and Control (IPPC) Licence in August 2007 (No. P ). A Technical Amendment to the licence was issued by the Agency on

3 Site Grid Reference: N E Attachment A.1: Site Location Plan

4 December 4, 2008 to facilitate increased production and resultant wastewater volumes. This application for a licence review is required to accommodate the proposed installation of 1-3 new borehole wells to abstract water from an aquifer to be used as cooling water at the facility before being discharged into the Mulkear River. The new wells will provide approximately 30 l/s (2592 m 3 /day) of water used as follows: The lens manufacturing equipment is currently cooled using mechanically driven compressors. Using water from an aquifer, which is a renewable source, to reduce the thermal load on the mechanical compressors requires less electrical power. This reduction in electrical power significantly reduces the carbon footprint indefinitely for the manufacturing process thereby complying with national governments green initiatives and benefiting the environment. This water will then be discharged directly to the River Mulkear at a maximum rate of 30l/s. A report prepared by Marcon provided in Attachment I shows that this water discharge will not affect the river in any significant negative way with regard to aquatic ecology. The cooling water will not come into contact with any chemicals or raw materials will not change in terms of chemical properties. Only temperature will be altered from approximately 12 o C to a maximum of 25 o C. The borehole water is essential to the core operations of the facility and has a significant beneficial effect on the environment and the future viability of the facility. A.3 Process Description Process Flow Diagrams detailing the general process for the manufacture of contact lenses are included in Figure A3. The steps involved in producing the contact lenses on each production line are essentially the same with the only change occurring in the washing step where water is replaced with IPA/water or PG mixture. Brief descriptions of the steps involved in the fully automated contact lens production process are provided below: 1. Injection Moulding The injection moulding equipment makes lens moulds from amorphous thermoplastics and transfers the moulded parts to the Lens Fabrication Cell. 2. Lens Fabrication Moulds are filled and the monomer is then cured and the cured lenses are demoulded.

5 I Attachment A.3: Process Flow Diagram

6 3. Hydration The lenses are hydrated as they move through the process where de-ionised water flows through the lenses. The production of the new products requires the use of an IPA/water mixture or a PG water mix. The solvent hydration modules is made up of three towers where the lens are hydrated in a temperature controlled solvent/water mixture 4. Primary Packaging The primary packaging equipment receives raw material (hydrocarbon thermoplastic), moulds primary packages and transfers these parts for dosing with a lens followed by lens packing solution. 5. Post Hydration The lenses are placed into the primary packages. Defective lenses are rejected and good lenses are transferred to the heat seal unit. The sealed packages are then transferred to the Sterilizer Cell. 6. Sterilization Products are steam sterilized. Once a valid sterilization cycle is completed, the lenses are removed from the sterilizer and transferred to the packaging area. 7. Cartoning The Cartoning cell loads lenses into preformed cartons. These process steps are supported by typical plant utilities including; water systems, boilers, compressed air, nitrogen gas and HVAC. In addition, the IPA-rich off-gases are vented to a thermal oxidiser (TO). A.4 Raw Materials Details on the principal materials that will be used (and produced) at the facility are given in Tables G.1 (i) and G.1 (ii). The following summarises the main raw materials used on-site: Cardboard Thermoplastic Paperboard Nitrogen Monomer DI Water IPA Foil laminate Saline solution A.4.1 Utilities The principal utility demands for the Vistakon facility are:

7 3 No. Natural gas fired steam generating boilers, each sized 5,000 kg/hr or 3.9 MW thermal input. These work in a duty/lag/standby arrangement. Limerick County Council water mains supply and on-site borehole groundwater abstraction for process and cooling purposes. Water softening and de-ionisation. Electricity required for all machinery, electrical equipment, lighting, electrical pumps and fan drives. Steam / Condensate and chilled water system for the heating/cooling package for process heating. Liquid and membrane generated nitrogen systems for process gas supply. Compressed air system for control. A.5 Chemical Storage Areas on-site There are a number of small chemical storage and hazardous material areas on the Vistakon site. Bulk IPA in the production process is stored in the tankfarm. The main storage areas are as follows: Boiler chemical storage areas Cooling tower chemical store Sprinkler pumps (diesel driven) Warehouse chemical stores Water room stores and water dosing area Transformers Contractor waste chemical stores Process / manufacturing area bunds IPA tank farm Tanker offloading/loading area with full tanker containment All these areas have adequate secondary containment, which prevent any potential releases from the site. All of these secondary containment facilities are tested on a regular basis. Trained emergency response and spill response teams are in place at the site and drills are carried out at the site on an annual basis. Spill kit stations are located throughout the site and are checked on a monthly basis for top-up. A.6 Waste Management A.6.1 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 and the ISO certified Environmental Management System. A.6.2 Hazardous Waste Management All hazardous wastes are labeled 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 oils and IPA. Where possible, these are sent for recycling or recovery. All documentation is retained on-site

8 in accordance with legislative requirements and the ISO certified Environmental Management. A.7 Emissions to Atmosphere There are minor emissions to atmosphere from the site boilers. These are fully detailed and described in Section E.1 of the application. Details of other minor emission sources, potential emission sources and fugitive emissions are also included. There is one main emission from the facility to atmosphere. This is from the Thermal Oxidiser used to abate (VOC) Volatile Organic Carbon emissions from the lens manufacturing lines utilising IPA and PG, tanker filling operations and the bulk and day IPA storage tanks. The mass emission levels from the minor emissions are very low, and in many cases below detectable levels. In order to assess the environmental impact of operational emissions from the Vistakon site, predictive air dispersion modelling of the main emission was undertaken. The impact of the predicted ground levels of individual pollutants on the surrounding environment was assessed using recognised air quality standards and guidelines. The maximum predicted ground level concentrations of the individual pollutants for all modelling scenarios considered are low and well within existing and proposed air quality standards or guidelines. There are no significant fugitive emissions to atmosphere from the facility. Air emission monitoring undertaken as part of the exisitng IPPC licence indicate operation well within Licence limits. A.8 Emissions to Waters There is one emission point to the Mulkear River from the Vistakon site, this emission consists of: Uncontaminated surface water run-off. In order to mitigate against potential contamination arising from accidental releases, spill prevention and control procedures have been developed as part of the site environmental management system. These procedures aim to ensure that spills are prevented / minimised and that those that do occur are controlled to prevent contamination. Oil/petrol interceptor (Class 1) are installed on the storm water run-off drainage system from hardstanding areas prevents oil contamination reaching the river. In addition, surface water discharge is monitored by CCTV camera. Where appropriate, delivery off-loading areas used by vehicles transporting substantial quantities of potentially polluting material and chemical storage areas are designed to contain spillages. In the event of a major fire, a firewater run-off retention facility of capacity 300 m 3 is provided to contain any contaminated firewater. This has been designed and sized in accordance with the EPA Guidance Note to Industry on the Requirements for Firewater Retention Facilities. Surface water from the IPA storage and tanker areas is monitored by TOC analyser and diverted to the firewater retention facility if contaminated. Uncontaminated borehole cooling water discharged to surface water has been assessed in detail, a comprehensive potenial impact assessment provided in Attachment I shows that this water discharge will not affect the river in any significant negative way with regard to aquatic ecology. The cooling water will not come into contact with any chemicals or raw materials will not change in EPA Export :14:36:21

9 terms of chemical properties. Only temperature will be altered from approximately 12 o C to a maximum of 25 o C. The borehole water is essential to the core operations of the facility and has a significant beneficial effect on the environment and the future viability of the facility. Taking into account the improved energy efficiency, the consequent reduction in Vistakon Ireland s carbon footprint and the fact that there will be no significant adverse impact on underlying aquifer or the Mulkear River, the installation 3 No. proposed new boreholes and the subsequent discharge of cooling water into the Mulkear River is not predicted to have any significant adverse environmental impact and will in fact have a positive impact with respect to energy efficiency and water treatment impacts. The use of borewell water will give a thermal reduction of 1238 kw giving a coefficient performance of 36. This results in a saving of 1,563,685 kwh/annum which equates to 1018 T/C02/annum. A.9 Emissions to Sewer There is one licensed emission (SE1) to sewer at the Vistakon site. All trade effluent wastewaters from Vistakon are discharged to the National Technology Park s foul sewerage system that discharges to the Castletroy Wastewater Treatment Plant (WWTP) operated by Limerick County Council. The process effluent and foul sewage systems are separate but combine at a location in the north-western corner of the site, which is upstream of the discharge point into the public sewer. This effluent is permitted to discharge to the technology park sewer under current IPPC Licence. Vistakon conducts daily, weekly and monthly analysis of the effluent discharge and the results are reported to EPA. IPA and propylene glycol are fully biodegradable in biological wastewater treatment systems. A.10 Emissions to Ground Currently there are no emission points to ground at the Vistakon site. Various containment measures (bunding of materials stored on-site, etc.) have been incorporated into the design of the plant to prevent / contain any accidental releases, which could potentially impact on ground or groundwater quality. Groundwater quality monitoring undertaken under the current IPPC licence has not indicated any groundwater quality issues. A.11 Noise Emissions There are various items of equipment which generate noise associated with the normal operation of the Vistakon plant. The minimisation of noise has been an integral part of the plant design and noise level criteria have been specified for all equipment to ensure that operation of the plant has minimal impact on any noise sensitive receptors (e.g. residential dwellings) in the vicinity of the plant. Various noise control measures have been incorporated into the design of the plant including the siting of equipment within the plant, housing of equipment within buildings, acoustic insulation of equipment and pipe-work. Noise levels at 4 No. boundary locations (AN1 AN4) and 2 No. noise sensitive locations (AN-5 and AN-6) are monitored on a periodic basis. Results show that the noise contribution from the Vistakon site does not exceed 55dBA during the daytime and 45 dba during the night time at the boundary locations. EPA Export :14:36:21

10 The plant is designed so that the noise contributions do not exceed the criteria in accordance with the EPA Guidance note on Noise in relation to Scheduled Activities. Thus the plant does not have any significant impacts on ambient noise levels. The predicted noise emissions from the borehole cooling project will not lead to any perceptible change in noise levels experienced at the nearest noise sensitive receptors. A.12 Sampling and Monitoring Monitoring of emissions to the environment is carried out to ensure that all control/treatment systems continue to perform to specification and that emission limit values are not exceeded. Provision for monitoring, sampling and analysis of environmental emissions has been incorporated into the design of the plant. Monitoring is carried out for discharges to surface waters and sewer. In addition, ambient monitoring is carried out on groundwater quality and noise levels to ensure the operation of the plant is not having any significant impact on the surrounding environment. A.13 Energy Efficiency The plant employs the latest technology and high efficiency equipment is used. Energy demand is optimised using high efficiency electrical drives on equipment (e.g. pump motors) and variable speed drives, where appropriate. Regular servicing and maintenance of equipment ensures that all equipment continues to perform to specification. Insulation has been incorporated into building structures and equipment at the plant to minimise heat losses. Energy Management forms part of the existing certified Environmental Management System (EMS) ISO 14001:2004 to ensure the continued efficient use of energy. As part of the Johnson & Johnson family of companies in Ireland, Vistakon is committed to be a leader in energy usage reduction and support significant environmental goals including CO2 reduction. Vistakon currently burn natural gas in their boilers. The proposed use of borewell water will give a thermal reduction of 1238 kw giving a coefficient performance of 36. This results in a saving of 1,563,685 kwh/annum which equates to 1018 T/C02/annum. A.14 Accident Prevention and Emergency Response Vistakon s philosophy is based upon accident prevention, coupled with appropriate emergency response to deal effectively with an accident or emergency situation, both during and outside of normal working hours. Safety and Environmental training, incident and accident investigation and corrective action follow-through, safe systems of work and a safe working environment are the fundamentals of this prevention approach, which is documented in Vistakon s Health, Safety and Environmental Policy and Manuals. A.15 Statutory Requirements No activity on-site and no emission from the site will breach any statutory requirements. The activities on the site will not have an adverse impact on any sites protected under the Habitats Directive. The activities on the site will not have an adverse impact on the surrounding environment. EPA Export :14:36:21

11 A.16 Environmental Management In accordance with Johnson and Johnson s Sustainability Practises and in an effort to achieve and demonstrate environmental probity, Vistakon has established and maintains an ISO 14001:2004 accredited Environmental Management System (EMS). This has been in place since June It aims to manage the company s environmental performance by systematically managing the potential impact of its activities, products and services on the environment. A.17 Quality Management A Quality Management System (QMS) based on the requirements of the international standard I.S. EN ISO 13485: 2000 Standard has been developed and implemented at the plant. The QMS provides a formal structure for quality management and establish and implement quality policy, objectives and responsibilities. A.18 Decommissioning A detailed description of the decommissioning activities has be carried out and reported in the Closure, restoration and Aftercare Management Plan (CRAMP). The facility will be decommissioned in accordance with the relevant national and international law in force at the time and in accordance with best practice. EPA Export :14:36:21