Integrated Pollution Prevention and Control (IPPC) Licensing Application Form For inspection purposes only. Consent of copyright owner required for any other use. EPA Reg. N o: (Office use only) Environmental Protection Agency P.O. Box 3000, Johnstown Castle Estate, Co. Wexford Lo Call: 1890 335599 Telephone: 053-9160600 Fax: 053-9160699 Web: www.epa.ie Email: [email protected] Page 1 of 235 EPA Export 29-05-2012:04:39:41 CONTENTS ABOUT THIS APPLICATION FORM ........................................... 3 SECTION A: NON-TECHNICAL SUMMARY ............................. 4 SECTION B: GENERAL ........................................................ 20 SECTION C: MANAGEMENT OF THE INSTALLATION............ 26 SECTION D: INFRASTRUCTURE & OPERATION ................... 30 SECTION E: EMISSIONS..................................................... 46 SECTION F: CONTROL & MONITORING .............................. 57 SECTION G: RESOURCE USE AND ENERGY EFFICIENCY...... 65 SECTION H: MATERIALS HANDLING .................................. 69 SECTION I: EXISTING ENVIRONMENT & IMPACT OF THE ACTIVITY........................................................................... 80 SECTION J: ACCIDENT PREVENTION & EMERGENCY RESPONSE ......................................................................... 95 SECTION K: REMEDIATION, DECOMMISSIONING, RESTORATION & AFTERCARE............................................. 98 SECTION L: STATUTORY REQUIREMENTS ........................ 103 SECTION M: DECLARATION.............................................. 111 ANNEX 1: TABLES/ATTACHMENTS....................................... 112 ANNEX 2: CHECKLIST FOR ARTICLE 10 COMPLIANCE ............. 144 For inspection purposes only. Consent of copyright owner required for any other use. Page 2 of 235 EPA Export 29-05-2012:04:39:41 ABOUT THIS APPLICATION FORM This form is for the purpose of making an application for an Integrated Pollution Prevention and Control (IPPC) Licence under the Environmental Protection Agency Acts, 1992 and 2011. There is a separate application form for applicants who wish to apply for the Pig & Poultry sector. The Application Form must be completed in accordance with the instructions provided in the IPPC Licensing Application Guidance Note. The Guidance Note gives an overview of IPPC Licensing, outlines the licence application process (including number of copies required) and specifies the information to be submitted in the application. The Guidance Note and application forms are available to download from the IPPC Licensing pages of the EPA’s website at www.epa.ie . A valid application for an IPPC licence must contain the information prescribed in the Environmental Protection Agency (Licensing) Regulations, 1994 to 2010. Article 10 of the Regulations sets out the statutory requirements for information to accompany a licence application. The application form is designed in such a way as to set out these questions in a structured manner and not necessarily in the order presented in Article 10. In order to ensure a legally valid application in respect of Article 10 requirements, please complete the Article 10 Checklist provided in Annex 2. This Application Form does not purport to be and should not be considered a legal interpretation of the provisions and requirements of the Environmental Protection Agency Acts, 1992 and 2011 and the Environmental Protection Agency (Licensing) Regulations 1994 to 2010. While every effort has been made to ensure the accuracy of the material contained in the Application Form, the EPA assumes no responsibility and gives no guarantees, undertakings and warranties concerning the accuracy, completeness or up-to-date nature of the information provided herein and does not accept any liability whatsoever arising from any errors or omissions. Should there be any contradiction between the information requirements set out in the Application Form and any clarifying explanation contained in the accompanying Guidance Note, then the requirements in this Application Form shall take precedence. For inspection purposes only. Consent of copyright owner required for any other use. Page 3 of 235 EPA Export 29-05-2012:04:39:41 SECTION A: NON-TECHNICAL SUMMARY A non-technical summary of the application is to be included here. The summary should identify all environmental impacts of significance associated with the carrying on of the activity/activities, and describe mitigation measures proposed or existing to address these impacts. This description should also indicate the normal operating hours and days per week of the activity. The following information must be included in the non-technical summary: A description of: − the installation and its activities, − the raw and auxiliary materials, other substances and the energy used in or generated by the installation, − the sources of emissions from the installation, − the environmental conditions of the site of the installation (e.g. soil and groundwater, air, noise, surface water), − the nature and quantities of foreseeable emissions from the installation into each medium as well as identification of significant effects of the emissions on the environment, − the proposed technology and other techniques for preventing or, where this is not possible, reducing emissions from the installation, − where necessary, measures for the prevention and recovery of waste generated by the installation, − further measures planned to comply with the general principles of the basic obligations of the operator i.e. (a) all the appropriate preventive measures are taken against pollution, in particular through application of the Best Available Techniques (BAT); (b) no significant pollution is caused; (c) waste production is avoided in accordance with the waste hierarchy in Council Directive 98/2008/EC on waste and section 21A of the Waste Management Acts 1996 to 2011 (as amended in For2011); inspection where purposes only.waste is produced, it is prepared for re-use, recycled or recoveredConsent of copyright or, where owner required that for is any technically other use. and economically impossible, it is disposed of while avoiding or reducing any impact on the environment (applicants should provide this information in the context of sections 29(2A), 32 and 38(5A) of the Waste Management Acts 1996 to 2011); (d) energy and other resources are used efficiently; (e) the necessary measures are taken to prevent accidents and limit their consequences; (f) the necessary measures are taken upon definitive cessation of activities to avoid any pollution risk and return the site of operation to a satisfactory state. − measures planned to monitor emissions into the environment. Supporting information should form Attachment N o A.1 Page 4 of 235 EPA Export 29-05-2012:04:39:41 This section presents a summary, in non-technical language, of the IPPC application for the Elanco Animal Health Facility in Finisklin, Sligo. The Installation and its Activities The Company formulates and packages a range of veterinary vaccines (biologicals) designed to protect the health of animals from diseases caused by a variety of viruses and bacteria. These sterile medicinal products are the result of extensive research regarding the quality, safety and efficacy of each prophylactic treatment. Elanco Animal Health Ireland purchased the facility at Finisklin Industrial Estate, Sligo in 2009, though the manufacturing of vaccines has a 20 year history at Finisklin. The current facility, which was constructed in 1991 and commenced manufacturing in 1992, consists of state-of-the-art biologicals manufacturing and testing facilities, which were designed specifically for veterinary vaccine manufacture. In 2011 construction began on the Stellamune extension to the Main Plant. The EPA have confirmed that the commissioning and qualification activities will be able to proceed under the conditions of the existing IPPC licence P0090-01. The facility currently employs in the region of 115 employees. The Main Plant manages the production process and consists of multiple clean room/contained sterile process areas with a central Bioservice area. An extension required for the Stellamune operations commenced construction in 2011 and is expected to commence manufacturing in 2013. The Quality Control (QC) Laboratories are required by the Veterinary Medicine Regulatory Authorities to be physically separated from the Main Plant. The QC Building functions in parallel to the manufacturing processes at the main plant. The QC Building provides the servicing, testing and certifying of all raw materials, in-process and environmental samples, and the release of final products. Another building at St.Colm’s, Finisklin, houses Labelling/Packaging, Warehousing and Administration. During 2006 a lease commenced on a further building (Support Services building) for office space only. It is located across the road from the Main Plant building. See Application Form Map 2 - Site PlanFor inspection which purposes is included only. in Attachment A.1 which Consent of copyright owner required for any other use. identifies the locations of the buildings. The existing Elanco facility currently holds an Integrated Pollution Prevention & Control (IPPC) licence (P0090-01). The development of the extension to the site has resulted in the requirement to revise the existing licence. This application relates to activities in the Main Plant (including the Stellamune Extension), the QC Building, the St.Colms Building and the Support Services Building. Where possible information in this application