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 has been based on the available records maintained by the site. Where appropriate information has also been included based on the expected impact of the Stellamune Extension.
Further details on the installation and its activities are presented in Section D of the Application.
Page 5 of 235
EPA Export 29-05-2012:04:39:41 Raw and Auxiliary Materials Used/Generated
The raw and auxiliary materials used at the facility include production and manufacturing raw materials, pharmaceutical ingredients, laboratory chemicals, cleaning materials, water and electricity. Additional materials used at the facility include packaging, maintenance materials and fuel oil.
Materials are also generally stored only in volumes required for manufacturing and are not reordered until the quantities stored reach a low level.
A comprehensive list with full details of the raw and ancillary materials, substances, preparations, fuels and energy utilised at the facility are provided in Table G.1(i) and Table G.1(ii).
Energy Usage
Electricity
In terms of energy usage in Elanco used 4,284,927kW of electricity in 2011. Greater than 90% of the site’s electricity consumption is utilized in the Main Plant where manufacturing takes place.
It is noted that electrical consumption by the facility has increased by approximately 8.9% in 2011 when compared to the 2010 reported figure. It is considered that this increase is indicative of both the increased production activity at the site and also the start of the commissioning and qualification phase of the Stellamune Extension.
The Stellamune Extension will share services with the existing Main Plant building. During the commissioning & qualification phase of Stellamune (Q4 2011- Q3 2012) it is expected that there will be additional short-term (peak) fluctuation demand on resources on top of normal production consumption. Additionally, there is an expectation of an overall increase in resource consumption over the short-to-medium term especially when the new Stellamune processes at the Main Plant come on-line, fully in 2014.
For inspection purposes only. Elanco Sligo want to assure theConsent Agency of copyright that owner required as the for any site other use. navigates through this transition period we are committed to using resources in an efficient and environmentally friendly manner based on continuous improvement, which is consistent with the site’s environmental policy.
Fuel 297,495 litres of light fuel oil was consumed by the facility in 2011. This represents a slight decrease in the quantity of fuel oil consumed in 2011 (-3%) when compared to the 2010 figure.
2,723 litres of kerosene was consumed by the facility in 2011, a 4.7% decrease in consumption when compared to the 2010 figure.
Municipal Water Usage In 2010 the facility used 27,292m3 of municipal water. The main activity which consumes municipal water at the facility is the cooling water system at the Main Plant, which utilizes approximately 75% of the water supply.
Elanco Environmental Management Programme (EMP) In 2010 and 2011 Elanco commenced and monitored a series of environmental initiatives to reduce energy usage, electricity consumption, carbon emissions and waste volumes. Elanco are committed to a policy of responsible energy management
Page 6 of 235
EPA Export 29-05-2012:04:39:41 through their Environmental Monitoring Programme, 2011 -2015. The future Stellamune operations have been considered in setting the EMP targets for 2011- 2015.
Elanco will continue to monitor fuel, water and electricity usage at the facility and report the results of this monitoring in the AER.
Further information on energy and resource usage is presented in Section G of the Application.
For inspection purposes only. Consent of copyright owner required for any other use.
Page 7 of 235
EPA Export 29-05-2012:04:39:41 The Environmental Conditions of the Site of the Installation
Atmospheric Emissions The main sources of air pollution in the vicinity of the facility are vehicular emissions from traffic accessing the industrial estate. Given the absence of “heavy” industrial operations within the industrial estate, the sources of air pollutants are relatively limited.
Given the limited sources of air pollutants and based on the results of various environmental monitoring assessments in 2003 (by the Environmental Protection Agency) and 2010 (by Elanco), it is considered that the European Air Quality Standards would be met in the vicinity of the Elanco facility. There will be no odour emissions from the site.
Airborne particle less than 10 microns in aerodynamic diameter (PM 10 ) and NO 2 are the two most significant air pollutants arising from traffic emissions in the vicinity of the facility. During the opening year 2014, the Stellamune extension is likely to give rise to a maximum of 10 - 15 additional staff vehicles per weekday and a limited number of additional deliveries. This would result in an insignificant increase in air pollutants in the immediate vicinity of the road into the Main Plant.
In accordance with the provisions of the current IPPC licence, monthly monitoring to verify the absence of biological agents in the air emissions from the Main Plant is undertaken. The 2008 - 2011 Annual Environmental Reports (AERs) for the Elanco facility, which were submitted to the EPA, indicate that no biological agents were detected in the air emissions.
Additionally, air emissions are monitored on a quarterly basis for TA Luft Class III Organics. The emissions were still within the licensed limits in 2008, 2009 and 2010.
It is noted that TA Luft Class III Organics list has been reclassified and that the EPA have indicated Isopropanol emissions should be now be classified under the Total Organic Carbon category. The Stellamune extension will result in the addition of minor emissions of Isopropanol to the atmosphere from the Main Plant. However, these 2 additional emission points have been classified as minor emission points in Section E For inspection purposes only. of the application and as such areConsent not of copyrightconsidered owner required to have for any othera significant use. impact on the environment.
Receiving Surface Water There are no surface water bodies on or in the vicinity of the site, and there is no direct release from the facility to surface water bodies.
The surface water drainage network on site drains surface water run off from hardstanding and roof areas to combine with the process water and foul water systems within the site boundaries.
The flow is then directed off-site into the Local Authority combined system before discharging to Sligo’s WWTP. The WWTP provides tertiary treatment and discharges to the Garovogue River Estuary which is designated as Cummeen Strand/Drumcliff Bay (Sligo Bay) proposed Natural Heritage Area (pNHA 000627), Cummeen Strand/Drumcliff Bay (Sligo Bay) Special Area of Conservation (SAC 000627) Cummeen Strand Special Protected Area (SPA 004035).
All emissions to the foul sewer from the site are monitored in accordance with the current IPPC license. The annual emission results presented in the 2007 – 2011 AERs submitted to the Agency demonstrate that the monitored emissions were well within the licensed limits.
Page 8 of 235
EPA Export 29-05-2012:04:39:41
Sewage Discharge All process, surface and sanitary water is combined and discharged to the Local Authority combined sewer which subsequently discharges to the Sligo WWTP.
Ground/Groundwater The facility is located within the Drumcliff-Strandhill Groundwater Body (GWB: IE WE G 0076) with the groundwater levels across the Drumcliff-Strandhill GWB generally being in the region of 0 – 5m below ground.
GSI information indicates that the groundwater flow direction across the site is typically toward the coastline, which would suggest a north or north easterly flow direction.
Bedrock Aquifer
The facility is located on a locally important aquifer, moderately productive only in local zones (LI) as categorised by the Geological Survey Ireland (GSI). These aquifers are generally expected to have low permeability and poor storage capacity and on this basis the aquifer would have a low ‘recharge acceptance’.
Groundwater Vulnerability
Based on their Interim classification scheme, the GSI has classified the facility and the surrounding area as having a high vulnerability of the groundwater to pollution (GSI Interim classification – July 2010).
Ground/Groundwater Contamination
There are no known ground or groundwater contamination, historical or current at the facility and the Geotechnical Investigation (GI) undertaken in October 2010 did not identify any areas of significant contamination.
Noise The nearest residential properties are located approximately 0.22km south east of the For inspection purposes only. proposed extension in the RathedmondConsent of copyright Estate. owner The required Cu formmeen any other use. Strand /Drumcliff Bay (Sligo Bay) Special Area of Conservation lies approximately 0.7km to the north of the site.
Weekday baseline noise measurements are undertaken on every 3 years in accordance with the provisions of the current IPPC Licence. This noise data was last gathered at measuring positions which were considered representative of the nearest noise sensitive receptors in June 2010 and levels were below the current IPPC licence limit of 55 dB(A).
Further details on the existing environmental conditions at the facility are presented in Section I.
Page 9 of 235
EPA Export 29-05-2012:04:39:41 The Sources Of Emissions From The Installation including 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 following are a brief description of the sources of emissions from the Elanco facility. Further details on the sources of emissions are presented in Section E of the Application.
The facility is currently licensed with regard to the management and monitoring of noise, air and wastewater emissions.
Emissions to Surface Water As with current procedures on site, there will continue to be no direct release to surface water bodies from the facility.
The surface water drainage network at each of the buildings within the Finisklin Industrial Estate drains surface water run off from hardstanding (car parking) and roof areas to the Local Authority combined drainage system (Municipal Sewer).
Emissions to the Local Authority Sewer (Sewage Discharge ) Sanitary wastewater from each of the facility buildings is discharged to the Local Authority combined sewer and comprises sewage and wastewater from: Toilets; Washrooms; and Shower Facilities.
Surface water run off from the Main Plant and QC Building, is combined with the process water generated at each of these buildings. This wastewater then passes through the on-site oil interceptor, installed at each building before joining the foul water waste stream.
The flow is then directed off-site into the Local Authority combined system before discharging to Sligo’s WWTP. The WWTP provides tertiary treatment and discharges to Garovogue River Estuary. For inspection purposes only. With the exception of a pH correctionConsent of copyrightsystem, owner wastew required forater any other is use. not treated on site. At both the Main Plant and QC Building, the discharge is monitored in accordance with the current IPPC licence conditions prior to its discharge to the sewer.
Mercury Management (Sewage Discharge) Thimerosal is an organomercurial salt chemical used at the facility as a vaccine preservative. No Thimerosal based primary materials are discharged from the facility.
However, the Clean In Place (CIP) process at the Main Plant results in very low concentrations of mercury being discharged in the process wastewaters from the site to the Local Authority combined sewer.
However, the isolation and capture at source process which is implemented at the Main Plant is estimated to reduce the levels of mercury in the CIP wastewater by 99.87% prior to discharge to the sewer and Sligo WWTP. This is implemented by capturing the wastewater generated during the first rinse of the CIP process into suitable containers for disposal off-site, rather than discharging the first rinse to the sewer.
With the effective implementation of this capture at source process, it has been determined that only 22.7grams of mercury will be discharged from the facility to the
Page 10 of 235
EPA Export 29-05-2012:04:39:41 combined sewer and Sligo WWTP each year. This figure is the equivalent of 4 human tooth fillings being discharged to the sewer each year.
Elanco have undertaken a number of modelling and predictive assessments to determine environmental legal compliance with regard to the levels of mercury from Thimerosal in the wastewater discharges.
The predicted worst case peak mercury concentrations in the Garovogue River estuary waters from the various modelling methods have predicted that mercury levels arising from the combined discharge of other municipal sources (492gm/year) and the Elanco wastewater (22.7gm/year) will remain well below the required environmental quality standards.
Full details on the management of these emissions to the sewer are addressed in the following sections:
Section E.3 : emissions to sewer; Section I.2 : potential for impact on final surface water receiving bodies; Section H.2 : solid waste management – with respect to sludge generation at the Sligo WWTP; and Section L : legal compliance .
Firewater Runoff There is a risk that in the event of a fire and in the event of a “loss of vessel integrity”, live material may be released from the Stellamune extension.
Specifically the Stellamune extension has been designed to allow potential fire water from the Stellamune manufacturing suite to be collected and decontaminated chemically before being neutralised. Firewater run-off from the Stellamune area will be contained on site prior to disposal in agreement with the EPA and Local Authority.
No fire water retention management issues have occurred to date at the existing Elanco facility. However, a Fire Water Risk Management Study has been commissioned by Elanco in accordance with EPA Draft Guidance Note to Industry on For inspection purposes only. the Requirements for Fire-WaterConsent Retention of copyright Facilitiesowner required for to any risk other assessuse. and identify any potential requirements with regard to firewater retention facilities/management.
Emissions to Air There are a number of emission points from the Main Plant, QC Building and St Colms Building. These points include emissions from a range of areas including live manufacturing rooms, non-live areas of the facility, steam vents, boiler and exhaust events and vents from electrical rooms etc.
Air Handling Units The Elanco facility will have 27 Air Handling Units (AHU) serving the manufacturing areas at the Main Plant and the QC Building. This includes 24 AHU’s serving the Main Plant, 20 of which serve the existing facility and 4 of which will serve the Stellamune extension. 3 AHU’s serve the QC Building. The AHU is a device used to condition and circulate air as part of the HVAC system.
HVAC Systems and HEPA filters As an element of the process operations, HEPA filters are in operation at the Main Plant and the QC Building.
The manufacturing rooms at the Main Plant where the cultures are grown are at a negative pressure to surrounding airlocks and the air leaving these areas is filtered
Page 11 of 235
EPA Export 29-05-2012:04:39:41 through the HEPA filters. The filters will contain any micro-organisms within the building in the unlikely event of a spillage from the closed system before it is disinfected. Waste that is potentially infected is autoclaved out of the antigen production suite and solid waste is bagged inside ‘UN’ biohazard bags for disposal to landfill.
The current monitoring undertaken for the IPPC licence for the facility shows that the HEPA filters are effective in preventing the emission of biological agents from the facility.
Three existing air emission points (Emission Points A-C) from the Main Plant are monitored for the following parameters in accordance with the current IPPC licence conditions:
Particulate Removal; Biological Agents (bacteria, virus or GMOs); and TA Luft Class 3 Organics (in relation to the use of Isopropanyl as a sanitiser at the Main Plant)
Of the three emission points at the existing Main Plant, one of these has been classified as a main emission point (Emission Point B) with the 2 (Emission Points A+C) remaining emissions points being classified as minor points.
With regard to the Stellamune operations, 2 additional (S1 and S2) minor air emission points of environmental significance have been identified and included for in this application.
Full details on the emissions to air from the facility are included in Section E.1 of the Application.
Noise Emissions The facility is located within an industrial area, the nearest residential receptor is located approximately 0.22km to the south east.
There are a number of noise sources arising from the facility. These noise sources are For inspection purposes only. associated with equipment suchConsent as chiller of copyright units, owner required condenser for any other units, use. air handling units, compressor units, HVAC exhaust and the standby generator.
In accordance with the provisions and conditions of the current IPPC licence, the emissions from the facility shall not give rise to sound pressure levels at noise sensitive locations near the activity which exceed 55dBA (Leq 15 minutes) during the daytime and 45 dBA (Leq 15 minutes) during the night time.
The noise sources at the facility are largely all internal will not introduce a tonal or impulsive noise source to the existing noise climate. Where noise sources from equipment will not meet the IPPC licence limits, vendors are required to provide noise abatement.
Further details on noise emissions are presented in Section E.5 of the Application.
Page 12 of 235
EPA Export 29-05-2012:04:39:41 Proposed Technology and Other Techniques for Preventing or Reducing Emissions from the Installation
Air Emissions Air emissions from the facility are controlled and mitigated through the use of:
Air Handling Units – HVAC Systems Sub-micron Filtration Systems HEPA Filters Fume hood / Fume cupboard Microbiological Safety Cabinets (MBSC)
These systems are used to condition and circulate air, to prevent any micro-organisms leaving the closed system before it is disinfected, and to provide a safe working area for personnel.
Further details on the control of air emissions are presented in Section F.1 of the Application.
Wastewater Emissions Process wastewater will be generated at the Main Plant and also at the QC Building.
The abatement, control and treatment processes in place at the Main Plant and QC Building with regard to wastewater emissions are summarised below with further details included in Section F.1 . pH Correction Systems A pH adjustment device is located at the Main Plant, and used for the adjustment of the pH of the process wastewater prior to discharge to sewer.
At the QC building there is a chart recorder, monitoring pH and flow . If the pH level is outside the limit value of the IPPC licence (5-10 pH units), the wastewater is directed to the hazardous waste chemical stores, where it is temporarily stored before disposal via a licensed contractor. For inspection purposes only. Consent of copyright owner required for any other use. Surface water/runoff Interceptors Surface water run off from the Main Plant and QC Building is discharged to combine with the process water at each building. This wastewater then passes through the on- site oil interceptors before joining the foul water waste stream within the site boundaries with final discharge to the sewer.
Mercury Management The isolation and capture at source process which is implemented at the Main Plant for the CIP wastewaters is estimated to reduce the levels of mercury in the CIP wastewater by 99.87% prior to discharge to the municipal sewer and Sligo WWTP. This is implemented by capturing the wastewater generated during the first rinse of the CIP process into suitable containers prior to discharge to the municipal sewer.
With the effective implementation of this capture at source process, it has been determined that only 22.7grams of mercury will be discharged from the facility to the combined sewer and Sligo WWTP each year. This figure is the equivalent of 4 human tooth fillings being discharged to the municipal sewer each year.
Elanco have undertaken a number of modelling and predictive assessments to estimate the concentrations of mercury in the receiving water after the Sligo WWTP and compare the predicted discharge to existing environmental quality standards. The
Page 13 of 235
EPA Export 29-05-2012:04:39:41 predicted worst case peak mercury concentrations in the River Garovogue Estuary waters from the various modelling methods have predicted that mercury levels arising from the combined discharge of other municipal sources (492gm/year) and the Elanco wastewater (22.7gm/year) in the Sligo WWTP discharge will remain well below the required environmental quality standards.
Wastewater monitoring At present, the combined discharge is not treated on site. However, at the Main Plant and QC Building, the discharge is monitored at a point prior to its discharge to the sewer.
At the Main Plant there is continuous monitoring of pH, flow and temperature and continuous sampling which is facilitated by a composite sampler.
For inspection purposes only. Consent of copyright owner required for any other use.
Page 14 of 235
EPA Export 29-05-2012:04:39:41 Measures for the Prevention and Recovery of Waste Generated by the Installation
Existing legislation and the legal requirements for the licensing of waste activities, in conjunction with the public awareness of environmental issues, are the driving forces towards sustainable development, energy conservation and waste minimisation.
Elanco has a well-developed waste management, minimisation and auditing strategy at the facility. This system is aimed at not only managing waste, but also at determining the most environmentally beneficial methods for controlling the generation of all wastes, and for reusing, recovering or disposing of them.
Materials used on site are generally stored only in volumes required for manufacturing and are not reordered until the quantities stored reach a low level to prevent additional waste streams.
Full details with regard to the solid and liquid waste management procedures which are implemented on site are addressed in Section H .
For inspection purposes only. Consent of copyright owner required for any other use.
Page 15 of 235
EPA Export 29-05-2012:04:39:41 Other measures planned to comply with the general principles of the basic obligations of the operator.
(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 Council Directive 75/442/EEC of 15 July 1975 on waste; where waste is produced, it is recovered or, where that is technically and economically impossible, it is disposed of while avoiding or reducing any impact on the environment;
(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.
Full details identifying that the site is compliant with BAT requirements is presented in Section I.8 of the Application.
Elanco adheres to the conditions of the current IPPC licence and monitors emissions to atmosphere, sewer and noise in accordance with the provisions of the licence with no significant pollution incidents occurring on site.
Elanco implement a programme of environmental management at the facility. As part of this programme, Elanco implement a programme of continuous improvement on site with regard to environmental performance and this programme is also integrated with Elanco’s commitment towards responsible energy management. For inspection purposes only. Consent of copyright owner required for any other use. There are a variety of energy management and reduction programmes ongoing at the facility with ongoing plans to continuously review and improve the level of energy usage being consumed. Energy management is currently included as part of the environmental management programme to ensure that relevant objectives are set and performance is measured.
Elanco has a well-developed waste management, minimisation and auditing strategy at the facility. This system is aimed at not only managing waste, but also at determining the most environmentally beneficial methods for controlling the generation of all wastes, and for reusing, recovering or disposing of them
Elanco have developed an Emergency Response Plan to:
Establish an integrated plan for emergency situations; Respond to emergencies; Limit the severity of emergencies when they do happen; and Ensure that designated employees are aware of their responsibilities for implementation of planned emergency response.
Page 16 of 235
EPA Export 29-05-2012:04:39:41
IPPC Application Form V2/12
The Plan outlines the roles and responsibilities of Elanco staff in the event of an emergency. This includes contingencies in the event that an emergency situation occurs outside of normal working hours.
The Emergency Response Plan also includes procedures for fire system sprinkler leakage, underground piping leakage, public water supplies disruption and electrical power outages.
A Residuals Management Plan (RMP) has been developed for the facility. It is considered that the scope of this plan addresses the required measures to minimise the potential impact on the environment in the event of cessation of the Elanco operations including the Stellamune extension or cessation of part of the site operations.
Elanco intends to continue the successful and profitable operations of the facility at Finisklin for many years to come and has no current plans to decommission all or part of the site.
For inspection purposes only. Consent of copyright owner required for any other use.
Page 17 of 235
EPA Export 29-05-2012:04:39:41
IPPC Application Form V2/12
Measures Planned to Monitor Emissions to the Environment
Elanco carries out sampling, analyses, measurements, examinations, maintenance and calibration, and reports the results of these works to the Agency.
This includes emissions to atmosphere, sewer and noise and will be continued to be implemented and adhered to as part of the new IPPC licence.
Emissions to Atmosphere Currently for three air emission points of significance at the existing facility;
A3-1: A-HVAC/HEPA Filtered Air (minor emission) A2-1: B-HVAC/HEPA Filtered Air (Main emission) A3-2: C-HVAC/HEPA Filtered Air (minor emission)
These emission points are monitored with regard to the prohibition on the presence of Production Biological Agents, particulate removal and monitoring for TA Luft Class III Organics in accordance with the requirements of the current IPPC licence
The Stellamune Extension within the Main Plant has 2 additional minor emission points of significance, referenced in the Application as;
A3-3: S1-HVAC/HEPA Filtered Air (minor emission) A3-4: S2-HVAC/HEPA Filtered Air (minor emission)
It is anticipated, in agreement with the Agency, that these additional emission points will also be monitored for TA Luft Class III Organics, the absence of Production Biological Agents and particulate removal.
Full details of the emissions to air can be found in Section E.1 of the Application.
Wastewater Emissions Elanco have developed a Sampling and Analysis of Effluent Discharge from Emission Point SW1 (Main Plant) and Emission Point SW2 (Quality Control Building) SOP (SOP 01-050-01). This SOP is developed to ensure compliance with the provisions of the For inspection purposes only. current IPPC licence. Consent of copyright owner required for any other use.
Samples are currently monitored for the following parameters:
Outlet Flow (continuous); BOD and COD (monthly and weekly); pH (continuous); Suspended Solids (weekly); Total Phosphorous (quarterly); Total Kjeldahl Nitrogen (quarterly); Total Ammonia (quarterly); Formaldehyde (SW1 only); Effluent Toxicity (annually); and Temperature (weekly).
It is proposed to continue to monitor at Emission Point SW1 and Emission Point SW2 for these parameters, subject to agreement with the Agency.
With regard to levels of mercury in the wastewater discharged from the Main Plant (SE1), it is proposed, in agreement with the Agency, that monthly monitoring of 24 hour flow proportional composite samples to monitor the mercury levels will be undertaken.
Page 18 of 235
EPA Export 29-05-2012:04:39:41
IPPC Application Form V2/12
There are no proposed additional emissions points required as part of this Application.
Within the Application the 2 emission points have been referenced as below:
Current Emission Point Reference No: SW1 (Proposed emission point SE1 ) Emission Type: Discharge from Production Building (Proposed emission point SE2); and Current Emission Point Reference No. SW2 (Proposed emission point SE2 ) Emission Type : Discharge from Quality Control Building
Full details of the emissions to sewer can be found in Section E of this IPPC Application.
Noise Emissions The limits specified in the current IPPC licence are 55 dBA (Leq 15 minutes) during the daytime and 45 dBA (Leq 15 minutes) during the night-time at the nearest noise sensitive location.
The current IPPC licence requires that a noise survey of the site operations is undertaken every 3 years, which will continue to be undertaken in agreement with the Agency.
Attachment A.1 Details Please note that Attachment A.1 contains the following maps and drawings: Application Form Map 1 – Ownership Map Application Form Map 2 – Site Plan Application Form Map 3 – Location Plan Application Form Drawing 1 – Utilities Main Plant and Stellamune Extension Application Form Drawing 2 – Utilities St Colms and Administration Building
Application Form Drawing For inspection 3 – Utilities purposes only. Quality Control Building Application FormConsent Drawing of copyright owner 4 –required Emissions for any other use. Plan Main Plant and
Stellamune Extension Application Form Drawing 5 – Emissions Plan St Colms and Administration Building Application Form Drawing 6 – Emissions Plan Quality Control Building Application Form Drawing 7 – Wastewater Structures Main Plant and Stellamune Extension Application Form Drawing 8– Material Storage Plan Main Plant and Stellamune Extension Application Form Drawing 9 – Material Storage Plan St Colms and Administration Building Application Form Drawing 10–Material Storage Plan Quality Control Building Application Form Drawing 11 – Application for IPPC Licence – Site Notice Locations
Page 19 of 235
EPA Export 29-05-2012:04:39:41
IPPC Application Form V2/12
SECTION B: GENERAL
B.1. Owner/Operator
Name*: Elanco Animal Health Ireland Limited Address: Finisklin Industrial Estate Sligo
Tel: 00353(0) 71 91 70005 Fax: 00353 (0) 71 91 70009 e-mail:
* This should be the name of the applicant which is current on the date this IPPC Licence Application is lodged with the Agency. It should be the name of the legal entity (which can be a limited company or a sole trader). A trading/business name is not acceptable.
Name and Address for Correspondence Only application documentation submitted by the applicant and by the nominated person will be deemed to have come from the applicant.
Name: Dr Pat Glynn Address: Elanco Animal Health Ireland Ltd Finisklin Industrial Estate Sligo
Tel: 00353(0) 71 91 70005 Fax: 00353 (0) 71 91 70009 e-mail: [email protected]
CRO No. and Address of registered or principal office of Body Corporate (if applicable) Address: Elanco Animal Health Ireland For inspectionLtd (478150) purposes only. Consent of copyright owner required for any other use. c/o Matheson Ormsby Prentice 70 Sir John Rogerson’s Quay Dublin 2 Tel: 01 2322000 Fax: 01 2323333 e-mail: [email protected]
If the applicant is a body corporate, the following information must be attached as Attachment N o B.1: a) Certified Copy of the Certificate of Incorporation. Attachment No B.1: b) the Company’s Registration Number from the Companies Registry Office Attachment No B.1: c) Particulars of Registered Office of the Company. Attachment No B.1:
Page 20 of 235
EPA Export 29-05-2012:04:39:41
IPPC Application Form V2/12
Name and address of the proprietor(s) of the Land on which the Activity is situated (if different from applicant named above):
Proprietor’s As Above Name: Address:
Tel: Fax: e-mail:
Name and address of the owner(s) of the building and ancillary plant in which the activity is situated (if different from applicant named above):
Name: As Above
Address:
Tel: Fax: e-mail:
B.2. Location of Activity
Name: Elanco Animal Health Ireland Limited Address*: Finisklin Industrial Estate Sligo
For inspection purposes only. Consent of copyright owner required for any other use. Tel: 00353 (0) 71 91 70005 Fax: 00353 (0) 71 91 70009 Contact Name: Pat Glynn Position: Head of Operations e-mail: [email protected] * Include any townland.
National Grid Reference 567767, 836528 (12 digit 6E,6N)
Location maps (≤A3), appropriately scaled, with legible grid references should be enclosed in Attachment B.2. The site boundary must be outlined on the map in colour.
The location map and site plan have been included in Attachment N o A.1 – Application Form Map 2 and Application Form Map 3.
Geo-referenced digital drawing files (e.g. AutoCAD files) in Irish Grid projection of the site boundary and overall site plan, including labelled emission, monitoring and sampling points,
Page 21 of 235
EPA Export 29-05-2012:04:39:41
IPPC Application Form V2/12
are also required. This data should be provided to the Agency on a separate CD-Rom containing sections B.2, E.6 and F.3.
Name of geo-referenced Application Form Map 1.DWG digital drawing files Application Form Map 2.DWG Application Form Map 3.DWG Application Form Drawing 4.DWG Application Form Drawing 5.DWG Application Form Drawing 6.DWG Name of CD-Rom with digital drawing files
B.3. Class of Activity
Identify the relevant activities in the First Schedule of the EPA Acts 1992-2011 to which the activity relates:
Schedule Class Description Note 1 Schedule 1 5.6 The manufacture of pesticides, pharmaceutical or veterinary products and their intermediates.
Note 1 : In order to give a precise identification select only those words from the description of the class or classes that best describes the nature of the activity for which the licence is being applied for.
B.4. Employees/ Capital Cost
Give-
(i) In the case of an established activity, the number of employees and other persons working or engaged in connection with the activity on the date after which a licence is required and during normal levels of operation, or
(ii) In any other case, the gross capital cost For of inspection the activity purposes only. to which the application relates. Consent of copyright owner required for any other use.
Number of Employees (existing facilities): Circa 115 employees
Gross Capital Cost (new proposals) € Not applicable
B.5. Relevant Planning Authority and/or Public Authority
Give the name of the planning authority in whose functional area the activity is or will be carried out.
Name: Sligo County Council Address: County Hall Riverside Sligo Co.Sligo Tel: 071 9111111 Fax: 071 9141119
Page 22 of 235
EPA Export 29-05-2012:04:39:41
IPPC Application Form V2/12
Planning Permission relating to this application:
has been obtained is being processed is not yet applied for is not required
Local Authority Planning File Reference 1049 No:
Attachment B.5 should contain all planning permissions, including a copy of all conditions, a copy of the planning inspector’s report and the required copies of any EIS should also be enclosed. For existing activities, Attachment N o B.5 should also contain all licences and permits past and present in force at the time of submission.
Attachment B.5 contains a development history of the Elanco site together with the planning permissions relating to the Stellamune Extension. A copy of the EIS is also included.
Previous planning permissions at the site dating from 1979 – 2011 are listed with numbers and dates. Copies of the planning permission grant notifications have been included in Attachment B.5 . Also included are copies of planning inspector’s reports which are available from the Planning Section of Sligo County Councils website. An EIS was prepared in 2010 for the proposed Stellamune Extension. A copy of this EIS has been included in Attachment B.5.
Where applicable, provide a copy of any screening for Appropriate Assessment report and Natura Impact Statement (NIS) that was prepared for consideration by any planning/public authority as defined in Regulation 2(1) of the European Communities (Birds and Natural Habitats) Regulations 2011 (S.I. No. 477 of 2011) in relation to the activity. Where a determination that an Appropriate Assessment is required has been made by any planning/public authority in relation to the activity, a copy of that determination and any screening report and Natura Impact Statement (NIS), and any supplemental information furnished in relation to any such report For inspection or stateme purposes only.nt, which has been provided to the planning/public authority for the purposesConsent of copyright of the owner Appropriate required for any otherAssessment use. shall be included in
Attachment No B.5.
Attachment B.5 contains a copy of the Appropriate Assessment Stage 1 Screening Report prepared for Elanco Sligo facility.
B.6. Relevant Water Services Authority
In the case of a discharge of any trade effluent or other matter to a sewer of a Water Services Authority, give the name of the Water Services Authority in which the sewer is vested or by which it is controlled.
Name: Sligo County Council Address: County Hall Riverside Sligo Co.Sligo Tel: 071 9111111 Fax: 071 9141119
Page 23 of 235
EPA Export 29-05-2012:04:39:41
IPPC Application Form V2/12
In the case of a discharge of any trade effluent or other matter to a sewer not vested by a Water Services Authority, the applicant must supply as Attachment N o B.6 ; (a) the name and address of the owner(s) of the sewer and the waste water treatment plant to which the sewer discharges and who are responsible for the quality of the treated effluent discharging to waters and (b) a copy of the effluent regulations and the agreement between the applicant and the aforementioned.
Attachment N o B.6 - Not applicable
Name: Not Applicable Address:
Tel: Fax:
B.7. Relevant Regional Health Service Executive
The applicant should indicate the Regional Health Service Executive where the activity is or will be located.
Name: HSE West Address: Community Services Markievicz House Barrach St Sligo Tel: (071) 9155175 Fax: -
B.8 Site Notice, Newspaper Advertisement and Planning Authority Notice. For inspection purposes only. Consent of copyright owner required for any other use. Attachment N o B.8 should contain a copy of the text of the site notice, a map (no larger than A3) showing its location on site (in accordance with Article 7 of the Regulations) and a copy of the newspaper advertisement. A copy of the notice given to the Planning Authority should also be included.
Attachment N o B.8 contains a copy of the site notice, map and a copy of the newspaper advertisement..
B.9 Seveso II Regulations
State whether the activity is an establishment to which the EC (Control of Major Accident Hazards involving Dangerous Substances) Regulations (S.I. No. 74 of 2006) apply.
If yes, outline how the process comes under these regulations.
Supporting information should be included in Attachment N o B.9 .
The activity is not an establishment to which the EC (Control of Major Accident Hazards involving Dangerous Substances) Regulations (S.I. No. 74 of 2006) apply. Page 24 of 235
EPA Export 29-05-2012:04:39:42
IPPC Application Form V2/12
Attachment N o B.9 . Not Applicable .
B.10 IPPC Directive
Specify whether the activity is a category of industrial activity referred to in Annex I of the IPPC Directive (2008/1/EC) and if yes specify the category.
Supporting information should be included in Attachment N o B.10 .
The activities at Elanco Sligo fall under category 4.5 of Annex I of the IPPC Directive (2008/1/EC):
4.5. Installations using a chemical or biological process for the production of basic pharmaceutical products.
Attachment N o B.10 . Not Applicable .
The activities at Elanco Sligo fall under category 4.5 of the Industrial Emissions Directive (2010/75/EU):
4.5. Production of pharmaceutical products including intermediates
For inspection purposes only. Consent of copyright owner required for any other use.
Page 25 of 235
EPA Export 29-05-2012:04:39:42
IPPC Application Form V2/12
SECTION C: MANAGEMENT OF THE INSTALLATION
C.1 Site Management & Control
Elanco Animal Health (Elanco) is currently licensed to the IPPC Directive under activity 5.6 – The manufacture of pesticides, pharmaceutical or veterinary products and their intermediates.
As identified in correspondence issued to the EPA in June 2011, Elanco is proposing to transfer the manufacture of certain vaccines and the secondary manufacturing of some finished products from other sites worldwide to their manufacturing site in Sligo. To facilitate this, an extension to the existing Main Plant (the Stellamune extension) is being constructed and commissioned to provide additional primary and secondary vaccine manufacturing facilities which will be in compliance with international Current Good Manufacturing Practice (CGMP) regulations, whilst maintaining production of existing products at the Sligo site.
The current site management practices including environmental, quality and maintenance management procedures which are implemented for the current facility will apply to the Stellamune extension once commissioned and operational.
Site Management Relevant site management details are provided below.
Environmental Management Details of the site management structure are outlined in the attached organisation chart for Environmental Management in Attachment N o C.1 .
The Environmental, Health and Safety (EHS) Team comprises an EHS Officer and EHS Specialist, both of whom possess the necessary technical knowledge, experience and qualifications appropriate to the role. The Environmental Manager holds a PgD in Environmental Protection and also an M.Sc in Environmental Protection and has six years experience working the area of environmental management. The EHS Officer reports directly to the Senior Operations Manager, who has overall plant environmental responsibility, and to the Elanco Lead Team members. For inspection purposes only. Calibration and Maintenance ManagementConsent of copyright owner required for any other use.
Although not directly related to Environmental Management, the Calibration and Maintenance Management team manage the maintenance and calibration of all equipment on site including treatment/abatement systems. This management system assists in ensuring that the facility is operating efficiently and contributes towards ensuring that the site operates in accordance with the IPPC Licence Conditions.
Details of the site management structure are outlined in the attached organisation chart for Calibration and Maintenance Management in Attachment N o C.1 .
The responsibility for the calibration and maintenance of systems on site lies primarily with the on-site Maintenance Manager.
All of the maintenance and calibration works are governed by Elanco Standard Operating Procedures (SOP). Each item of equipment at the Elanco facility has an associated SOP and quality record sheet which details the maintenance and calibration procedures.
A complete set of maintenance and calibration SOPs is maintained on the internal Elanco network. However, an overview of these procedures is provided in Attachment N o C.1 relating to the work flow for calibration and maintenance works at the site. Page 26 of 235
EPA Export 29-05-2012:04:39:42
IPPC Application Form V2/12
Site Controls A number of management systems and controls are implemented at the Elanco facility.
It is considered that the integrated management of these systems contributes to the ongoing compliance of the Elanco facility with the EPA IPPC licenced limits and conditions.
EPA IPPC Licence As required by the site’s current IPPC licence there is regular monitoring of emissions to air and sewer and also noise emissions.
The results of this monitoring and details of all waste arisings are reported to the Environmental Protection Agency in the Quarterly and Annual Environmental Reports.
See attached 2008, 2009, 2010 and 2011 AERs included in Attachment N o C.1 .
Abatement and Treatment Systems Elanco has significant experience and technical capability in the pharmaceutical industry, provided by a highly trained workforce who possess the necessary qualifications, experience and technical competence in their respective areas of responsibility.
Management and responsibility for operation and control of all abatement and treatment systems on-site is assigned to the appropriate personnel. Each of the abatement and treatment systems on-site have an SOP for their operation, management and maintenance. Staff involved in these systems receive the appropriate training for the correct and effective use of the abatement and treatment systems, and training records for these are maintained on site.
Waste Control Systems The responsibility for Waste Control Systems rests with the EHS Officer and written procedures are in place for the control and disposal of all waste stream generated at the facility.
These include the Non-Hazardous Waste Control Management SOP (SOP-01-009) and the Disposal of Bio-hazardous Waste at Elanco Sligo SOP (SOP-01-008). For inspection purposes only. Consent of copyright owner required for any other use. Elanco has a well-developed waste management, minimisation and auditing strategy. The system is aimed at managing waste and determining the most environmentally beneficial methods for controlling the generation of all wastes, and for reusing, recovering and disposing of them.
SOP’s are in place for the storage, segregation and separation of waste streams on-site and complete records of all waste documentation is maintained by the EHS Department. Further details on the handling of waste at the facility can be found in Section H.2 .
Quality Management System Elanco has a clear, documented Quality Policy which projects the company's vision and the management's commitment to Quality.
Overall responsibility for the implementation of the quality policy lies with the Quality Manager.
Elanco Sligo Quality Policy
We are committed to excellence – in the results we achieve and in how we achieve them.
Page 27 of 235
EPA Export 29-05-2012:04:39:42
IPPC Application Form V2/12
Do our jobs right Focus on what is important Strive for continuous improvement Think strategically and execute flawlessly. Manufacture products that will be safe and efficacious, comply with current requirements of all laws, regulations and codes of practice relevant to countries in which products are marketed and meet or exceed customer/patient quality expectations all of the time Strive for operational excellence by identifying and implementing appropriate product quality improvements, process improvements, variability reductions, waste reduction and quality system enhancements across all departments. Apply science-based risk management to GMP related activities. We all have a personal responsibility to identify events which may impact on product quality, always THINK
These quality principles and policies establish a foundation for a quality culture at the site which enhances the implementation of the Environmental Policy and Management System which are described below.
Elanco Environmental Policy
It is the policy of Elanco to conduct business responsibly and in a manner designed to protect the environment. As good business citizens Elanco must be conscious of the effects of operations on the environment – land, water, air and sound. Elanco will continue to comply with all Regional, National, International and Corporate laws and regulations relating to the protection of the environment.
Elanco are committed to continuous environmental improvement is embodied in the site Environmental Management System. Elanco ensure that the operational controls which are in place to manage environmental systems areFor inspection safe, purposeseffective only. and robust. Consent of copyright owner required for any other use.
Elanco instil environmental responsibility through all levels of the organisation, by employee awareness programs and training. Elanco will foster openness and dialogue with employees and the public on environmental performance.
A copy of the Environmental Policy for the facility is included in Attachment N o C.1 .
C.2 Environmental Management System (EMS)
Although Elanco do not have an accredited EMS implemented at the facility, a programme of environmental management is implemented and managed by the EHS Department. This programme is designed to ensure environmental protection, prevention of pollution and compliance with legal and licence conditions at all times.
Additionally, in accordance with typical requirements of an EMS, Elanco also implement a programme of continuous improvement on site with regard to environmental performance.
Page 28 of 235
EPA Export 29-05-2012:04:39:42
IPPC Application Form V2/12
Copies of the Environmental Policy and Energy Policy for the facility are included in Attachment N o C.1 .
Elanco has an Environmental, Health and Safety Induction Program which is provided to all employees and contractors on site. This demonstrates the commitment of Elanco to promoting environmental awareness to its staff. The program includes a facility overview, introduction of EHS policies and legislation, emergency procedures, safety rules, hazard identification, security considerations, and environmental protection. A copy of training materials is available upon request.
It is the Policy of Elanco to conduct business responsibly and in a manner designed to minimise its impacts to the environment. To ensure the sustainability of its operations Elanco are committed to continuous environmental improvement and responsible energy management.
C.3 Hours of Operation
(a) Proposed hours of operation.
Below are the normal hours of operation for the facility.
Facility Area Normal Hours of Operation Quality Assurance 8am-5pm Monday – Friday SSB 8am-5pm Monday – Friday St.Colm’s 8am-5pm Monday – Friday Labelling and packaging 8am-5pm Monday – Friday Main Plant 6am -10pm Monday to Friday Two shifts 6am-2pm and 2pm to 10pm
Please note that these are the normal hours of operation, some staff choose to begin earlier or finish later than these core hours.
(b) Proposed hours of construction and development works and timeframes. For inspection purposes only. Consent of copyright owner required for any other use. For any construction works at the facility working hours in general will be restricted to 07:00 to 19:00 Monday to Friday and 07:00 to 16:00 on Saturday. Requirements for working outside these hours will require prior notification to Sligo Borough Council and will be kept to a minimum to avoid disturbance to the surrounding environs.
(c) Any other relevant hours of operation expected
None
Page 29 of 235
EPA Export 29-05-2012:04:39:42
IPPC Application Form V2/12
SECTION D: INFRASTRUCTURE & OPERATION
D.1. Operational Information Requirements
Describe the plant, methods, processes, ancillary processes, abatement, recovery and treatment systems, and operating procedures for the activity, to include a copy of such plans, drawings or maps, (site plans and location maps, process flow diagrams), and such other particulars, reports and supporting documentation as are necessary to describe all aspects of the activity. Maps and drawings must be no larger than A3 size.
Introduction Elanco 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. Each product is individually licensed, after submission of extensive research data, in each market country (including Ireland) by the relevant Regulatory Authority (e.g. European Medicines Agency).
These regulatory authorities have approved the current facility through periodically auditing the operations and facilities in Sligo. The Stellamune operations, once commenced, at the Elanco facility will also be subject to this auditing process. This includes the Irish Medicines Board (IMB), whose role is to protect and enhance public and animal health through the regulation of human and veterinary medical products.
A current list of the final products and their intermediates with details on their biological components is provided in this section. It is envisaged that additional products will be added to this product list from time to time as the manufacture of other products is transferred from other Company locations or the Elanco Research and Development group. Any future transfer of new products to the facility at Elanco will require further consultation with the Irish regulatory bodies, including but not limited to the EPA and the Department of Agriculture,
The Site/Facility For inspection purposes only. Consent of copyright owner required for any other use. The veterinary vaccines (biologicals) which are produced require a specific range of activities/ processes which are outlined in the Operations Flow Diagram in Attachment D.1 . These processes are undertaken at the Elanco facility within the following key areas:
Main Plant (including the Stellamune Extension); Quality Control (QC) Building; and Labelling/Packaging, Warehousing (St.Colm’s) and Administration facilities (SSB Building)
The details on where the processes are managed within the facility and the main infrastructural requirements are described in the paragraphs below. With regard to the sections below, it is noted that the application has been developed to address the current Main Plant together with the Stellamune extension to facilitate appropriate consideration under one Licence Application.
However, the Stellamune extension is currently in the commissioning phase and production operations will not commence from this extension without prior agreement with the EPA with regard for the IPPC Directive.
Page 30 of 235
EPA Export 29-05-2012:04:39:42
IPPC Application Form V2/12
Please refer to outline drawings of the Site at the Finisklin Industrial Estate ( Application Form Map 2 - Site Plan ) in Attachment A.1 indicating the locations of all activities and identifying all buildings and facilities.
Facility Products A range of veterinary vaccines (biologicals) are produced at the facility.
The products are for the protection of the health of companion animals, such as dogs & cats and larger animals, such as horses, pigs and cattle. The medicinal products are presented as injectable sterile liquids, both in vials and in syringes and in freeze-dried form.
Both inactivated vaccines and also Modified Live Vaccines (MLV) are produced at the facility. Inactivated vaccines are vaccines where the virus particles are grown in culture and then killed using chemical solutions without affecting their antigenicity. MLV vaccines incorporate viruses which were modified during product research such that they cannot cause animal disease but can still evoke a protective response in the host animal.
A brief description of the ranges of products manufactured at the facility is provided below with detailed process flow diagrams details in Attachment No. D.1
Products currently manufactured at the facility or programmed to be added 2013/2014 include the following: Duramune Range (Duramune 7,8) – MLV canine vaccine Bronchishield - MLV canine vaccine Pentofel, Fel-O-Vax iCHP, iChpChlam – Inactivated feline vaccine Feline 3 (Katavac) – MLV feline vaccine Triangle 3,4,5 – Inactivated bovine vaccine Artevac – Inactivated equine vaccine Duvaxyn Rotavirus – Inactivated equine vaccine West Nile – Inactivated equine vaccine Fluvac T – Inactivated equine vaccine Felocell (Future Product) – MLV feline vaccine Duvaxyn IET (Future Product) For inspection – Inactivated purposes only. equine vaccine Consent of copyright owner required for any other use. Stellamune (Future Product) – Inactivated porcine vaccine
As Elanco continues to grow its business at the Sligo facility, additional products may be introduced to the site. The process of adding new products will include consultation with the EPA.
Materials Used on Site With regard to the materials being used on site, there have been no recorded historical pollution incidents or prosecutions against the facility.
Additionally, there are no recorded underground storage tanks or disused sites of waste disposal/treatment in the area and none have been identified during previous ground investigations at the facility.
An extensive inventory of the raw materials currently used on site and also those required for the future Stellamune operations are listed in Section G of this application. This list includes details on the master/working biological materials, such as animal cells, virus and bacterin which are used on site.
Page 31 of 235
EPA Export 29-05-2012:04:39:42
IPPC Application Form V2/12
Genetically Modified Organisms (GMO) are currently in contained use for production purposes at the facility. GMO’s will not be included in the production process at the Stellamune operations. “Contained use” means that physical, chemical or biological barriers, or any combination of barriers, are used to limit the contact with, and to provide a high level of protection for, humans and the environment.
The EPA was notified of the use of GMO at the facility and consent obtained from the EPA, in accordance with the Genetically Modified Organisms (Contained Use) Regulations, 2011 (S.I. No. 73 of 2001). The EPA issued consent for the contained use of Class 2 GMMs (Genetically Modified Micro-organism) on the 23 rd of August 2006 and on the 17 th July 2009. The Stellamune production process does not involve any GMOs. The Department of Agriculture has issued licences for the importation of each Biological Agent used at the facility. Elanco have engaged in consultation with the Irish Medical Board (IMB) and the Department of Agriculture regarding the new Stellamune production process and all licensing requirements will be addressed.
Facility Processes and Unit Operations Overview The key processes at the Elanco facility include:
Media Manufacture – involving the internal formulation of media, adjuvants and stabilisers; Cell Growth and Antigen Manufacture – cells are grown in roller bottles and then scaled up to produce the Antigen. Approximately 11,000 litres of Antigen per annum is currently produced by Elanco. Both ‘live’ and ‘inactivated’; Downstream processing – where the Antigen is concentrated via ultrafiltration and homogenised; Product Blending (Formulation) – Live and inactivated blends are prepared; and Filling – Live and inactivated products are filled in vials or syringes.
Unit Operations A Unit Operations Flow Diagram which is relevant to the current and also Stellamune o. operations is presented in Attachment For N inspection D.1 purposes with only. an overview of each of the processes Consent of copyright owner required for any other use. involved in the preparation of veterinary vaccines.
Any waste streams from each unit operation are identified together with details on the disposal methods used. Additionally, a description of each of the unit operations i.e. product blending, product filling is provided in the paragraphs below.
An overview of the unit operations and their relevant location within the facility is detailed below.
Main Plant The Main Plant manages the production process and consists of multiple clean room/contained sterile process areas with a central Bioservice area. The extension required for the Stellamune operations commenced construction in 2011 and is expected to commence manufacturing in 2013.
The functions of the Main Plant are concerned with all aspects of the formulation/packaging process from the raw materials to the finished, packed product.
Page 32 of 235
EPA Export 29-05-2012:04:39:42
IPPC Application Form V2/12
Warehouse (Main Plant) All materials to Elanco are received initially at the St.Colm’s building. Deliveries of raw materials and equipment are quality checked prior to release for controlled use to other areas of the facility such as the warehouse at the Main Plant.
Volumes of materials are relatively small and no materials are stored in quantities likely to pose a hazard or endanger the environment. No substances are stored in volumes above the thresholds relevant to the Control of Major Accident Hazards involving Dangerous Substances) Regulations (S.I. No. 74 of 2006). Refer to Table G.1 (i) for details on the average volumes of materials being stored at the facility.
In-process product and final packaged goods are also stored at an appropriate temperature in the Main Plant warehouse or cold rooms.
Processing Areas (Main Plant) – Bioservice Area The Bioservice area is a central supply area which provides ancillary services to the main manufacturing processes. The Bioservices area is equipped with sterilizing autoclaves, media preparation and cleaning facilities and waste discard points. This area will service both the existing Main Plant operations and the Stellamune Extension.
Validated autoclaves at this location are used to prepare sterile equipment for use in process rooms and also to sterilize materials contaminated with Biological Agents prior to discard or cleaning, as appropriate.
Waste from all processing areas within the existing Main Plant (and from Stellamune in the future) is passed to the Bioservice Area for sterilization and segregation.
Household type waste is disposed of to general waste using bags and mobile skips for removal to landfill or recycling by Licensed Contractors. Dilute, aqueous detergent and disinfectant solutions are discarded to either one of two drains in the Bioservice area which discharge to the municipal sewer via a controlled conduit. Additionally, biologically-spent, dilute, aqueous, nutrient solutions from processing are autoclaved before discarding as above. All discharges to the municipal sewer at the Main Plant including those from the Bioservice area are monitored in accordance with current licence conditions at Emission Point SE1 (currently For inspection purposes only. termed as SW1 under the existing licence).Consent of copyright owner required for any other use.
Processing Areas (Main Plant) – Antigen Stock Preparation Specific processing areas at the Main Plant are concerned with the preparation of Antigen Stock, the biological, antigenic component of the vaccines which are produced. Antigen Stock is prepared for both the inactivated vaccines and also Modified Live Vaccines (MLV).
These preparation processes for vaccines involve aseptically combining nutrient solutions with seed animal cells, virus or bacteria according to documented, approved procedures under cleanroom conditions.
The operation consists of mixing, dispensing, incubation and collection processes which all take place under strictly aseptic conditions. Where live Biological Agents are handled, biocontained conditions are also used.
Incubation equipment includes shake-flasks, roller bottles, and bioreactors commonly used in the industry with process control of incubation parameters (e.g. pH, temperature, mixing) ensuring that the biological processes give optimal yields.
Page 33 of 235
EPA Export 29-05-2012:04:39:42
IPPC Application Form V2/12
The antigen stock for inactivated vaccines is then treated with chemical solutions to kill the biological material without affecting efficacy. This is done using validated methods, and quality tests which are undertaken to prove inactivation prior to materials being further processed. The material may also be concentrated using sterile equipment.
The MLV antigen stocks are stored live under low temperature conditions during quality testing of samples and prior to further processing.
All waste items generated in a “live” room are classed as potentially infectious waste. Therefore it must be sterilized before disposal. Consumable wastes produced in these “live” rooms at Elanco are sent off site to be sterilised by an approved waste contractor. Disinfectant solutions and dilute formalin sanitising fluids from the concentration operations are discarded directly to drain. Any pH variations are managed in the pH correction system. Every effort is made to collect residual formalin based wastes and waste solutions containing formalin. These are temporarily stored in secure containers before disposal via an approved waste contractor.
Processing Areas (Main Plant) – Product Blending Product blends are prepared in designated areas at the Main Plant using approved/tested antigen stock(s), adjuvants, stabilising solutions and preservatives, as appropriate.
The operation consists of a formulation/mixing exercise conducted under sterile conditions. Additionally, MLV’s are blended under sterile and biocontained conditions.
Little waste is generated by this operation but may include paper and plastic which is autoclaved, as appropriate, reducing bulk considerably.
Processing Areas (Main Plant) – Product Filling Product filling of inactivated vaccines takes place in designated areas under sterile conditions using filling machines which accurately aliquot the product blend into syringes, vials or multi- dose bottles. These are immediately sealed in-place.
MLV vials are filled under sterile and biocontained conditions, partially stoppered and freeze- dried rapidly following blending to maintain viability. The vials are then sealed.
For inspection purposes only. Little waste arises from the productConsent filling of copyright operat ownerion required but for may any other include use. paper and some waste containers. Surplus syringes are either destroyed by a contractor or the components are discarded separately.
Processing Areas (Main Plant) – Product Packaging Product packaging takes the filled product and applies the appropriate product label including the batch number and expiry date.
Labelling machines apply these to the syringes, vials or bottles. Labelled products are then packaged into cartons and boxes for dispatch.
Only household type wastes arise from packaging including paper, cardboard and surplus labels. Product packaging waste is defaced prior to disposal to general waste.
Table D.1.1 below provides a summary of the emissions and waste streams related to the Main Plant activities.
Parameter Details Emissions to Atmosphere Boilers, Air Handling Units, HEPA/HVAC systems Emissions to Sewer Process generated wastewater and surface water run- Page 34 of 235
EPA Export 29-05-2012:04:39:42
IPPC Application Form V2/12
off are discharged to the combined sewer Noise Emissions Refrigeration compressor unit, emergency generator, chiller units, boiler house, HVAC Exhaust, etc. Waste Streams Chemical and biohazardous waste i.e. formalin based waste solutions, general waste to landfill, waste electrical and electronic equipment, paper, packaging, cardboard, surplus labels, glass, waste containers, etc.
Quality Control Building 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. Products are tested at each stage of production to assure the quality of the process and product at every stage and these tests include identity, sterility, potency and inactivation.
Waste arising from this testing activity is much smaller in volume compared to the Main Plant. It includes biologically-spent, aqueous, nutrient solutions which are autoclaved next to the laboratory before disposal to sewer via a controlled conduit. Cooling water and steam condensate from HVAC and autoclaves go to drain also.
All waste items generated in a “live” room are classed at potentially infectious waste. Therefore these are sterilized before disposal. Consumable wastes produced in “live” rooms at Elanco are sent off site to be sterilised by an approved waste contractor. Small quantities of toxic and dangerous waste and solvents used for testing purposes are stored in secure bunded units and disposed of by a Licensed Contractor.
Table D.1.2 below provides a summary of any emissions and waste streams related to the QC Building activities.
Parameter Details
Air Boiler, ForAir inspection Handling purposes Units, only. HEPA/HVAC Water QCConsent wastewater of copyright owner and required surface for any other water use. run-off discharged to combined sewer Noise Air compressor unit, HVAC Exhaust. Waste Chemical and biohazardous waste i.e. formalin based waste solutions, general waste to landfill, waste electrical and electronic equipment, paper, packaging, cardboard, surplus labels, glass, waste containers, etc.
Labelling/Packaging, Warehousing and Administration facilities (St Colms) Labelling/Packaging and Warehousing is carried out at St. Colms. All materials coming into Elanco are first received here before distribution to the various manufacturing, QC and administration areas. Final products are also stored here before being exported off-site.
Elanco also lease the SSB Building for office space only. It is located across the road from the Main Plant building. The SSB Building houses a range of administration and support services employees.
This includes the Environmental, Health and Safety team, the Quality Control administration team and the Engineering Team.
Page 35 of 235
EPA Export 29-05-2012:04:39:42
IPPC Application Form V2/12
Table D.1.3 below provides a summary of any emissions and waste streams related to the SSB Building and St. Colm’s activities.
Parameter Details Air Boilers, recirculation cabinet Water Domestic and sanitary wastewater discharged to sewer. Noise Refrigeration unit. Waste General waste to landfill, waste electrical and electronic equipment, paper, packaging, glass, printer cartridges, wooden pallets , etc.
Please note that for full details on noise, atmospheric and wastewater emissions from the Elanco facility refer to Section E . For details on waste streams, volumes and management procedures please refer to Section H .
Process Flow Diagram of the manufacturing of products at the Elanco Sligo facility. The process flow diagram in Attachment D.1 presents an overview of the manufacturing process of products at the facility which is relevant to current and future manufacturing practises.
Site Infrastructure
Heating Ventilation and Air Conditioning Systems (HVAC) and High Efficiency Particulate Air (HEPA) filters There are a number of emissions to atmosphere points from the facility operations. These include emissions such as those from the HVAC systems and HEPA filters, non-live areas of the facility, steam vents, exhaust vents (i.e. boilers) and vents from electrical rooms
Specifically the Heating Ventilation and Air Conditioning (HVAC) Systems and High Efficiency Particulate Air (HEPA) filters are supplied using appropriate fixed capital equipment built into the Main Plant and the QC Building.
Most of the processing and testing takes For inspection place purposes in c only.leanroom, aseptic conditions and this working environment is controlled Consentfor humidity of copyright ownerand required temperature. for any other use. Additionally, the processing of biological agents takes place in biocontained conditions. These required conditions result from operating procedures, special equipment such as autoclaves and also the HVAC Systems in each processing/testing areas which are located on site and supply conditioned, sterile air into each process or testing area via HEPA filters.
Defined pressure differentials are maintained in each area and high air-charge levels are accomplished. For biocontained areas at the Main Plant (including the Stellamune extension) and QC Building, HEPA filters also scrub the air leaving the processing and testing areas ensuring environmental protection from particulate emissions and biological agents. As Elanco has been categorised as Containment Category 2 for Genetically Modified Organisms (GMOs) these measures are over and above the requirements as set out in S.I. No.73/2001 – Genetically Modified Organisms (Contained Use) Regulations, 2001.
As the processing and testing activities do not generate aerosols, the HVAC containment system is low risk. Nevertheless, it is validated on a periodic basis and critical instrumentation is calibrated. Approval for the system was obtained from the Regulatory Authorities for veterinary medicines, including the Department of Agriculture in Ireland.
Page 36 of 235
EPA Export 29-05-2012:04:39:42
IPPC Application Form V2/12
Isopropyl alcohol (IPA) is used to sanitise materials and surfaces and will be used at the Stellamune extension. Isopropyl alcohol evaporates quickly and is diluted rapidly by the high air change-rates in the processing areas. This forms an emission from the HVAC outlets. Any loss of power would result in these materials residing longer in the areas than under normal conditions but would not lead to any uncontrolled release to atmosphere.
Refer to Tables E.1 (iii) and E.1 (iv) for details on main and minor emissions to atmosphere.
Deionized/Purified Water Systems (Main Plant and QC Building) The Deionized/Purified water systems filter and treat municipal water coming into the Main Plant (including the Stellamune extension) and the QC Building to the required purity level. The filter elements are periodically backflushed to remove accumulated biological/mineral debris. The pH of this material is neutralised prior to its dilution to sewer.
Plant cooling is needed for equipment such as the HVAC, autoclaves, freeze-dryer and bioreactors. This utilises municipal water as economically as is practicable and is discharged to sewer via the controlled conduits.
Boiler House (Main Plant) The boiler house operations, located at the Main Plant, burn fuel and use water to generate steam for domestic heating, sterilising and HVAC operation at the Main Plant and this will also serve the Stellamune Extension.
The St.Colms building is served by two domestic boilers and the SSB Building and QC Building are each served by one domestic boiler to supply hot water and heat to the buildings.
Low sulphur fuels, periodic preventative maintenance and best boiler-house practice are used to minimise smoke effluent and to maximise efficiency of combustion. A back-up electricity generation system is similarly maintained.
Refer to Tables E.1 (i) and E.1 (iv) for boiler capacity and emissions details.
Loss of Power / Conceivable Malfunctions Loss of power or other conceivable malfunctions at the Main Plant and QC Building would mean For inspection purposes only. processing or testing would stop butConsent there of copyright would owner be requiredno emissions for any other use.likely to arise as a result.
Additionally, an Emergency Generator is maintained at the Main Plant to provide power in the event of a loss of power.
Site Production Capacity Table D.1.4 below provides a summary of the typical of products manufactured at the facility. The annual capacity of the facility is considered confidential and can be made available to the Agency upon request.
Vaccine Species Vaccine Type Felocell Feline MLV Duvaxyn IET Equine Inactivated Stellamune Porcine Inactivated Duramune Range (Duramune 7,8) Canine MLV Bronchishield Canine MLV Pentofel, Fel-O-Vax iCHP, iChpChlam Feline Inactivated Feline 3 (Katavac) Feline MLV Triangle 3,4,5 Bovine Inactivated Artevac Equine Inactivated Page 37 of 235
EPA Export 29-05-2012:04:39:42
IPPC Application Form V2/12
Vaccine Species Vaccine Type Duvaxyn Rotavirus Equine Inactivated West Nile Equine Inactivated Fluvac T Equine Inactivated
Further details on the raw materials, intermediates and products at the facility are discussed in Section G.
For inspection purposes only. Consent of copyright owner required for any other use.
Page 38 of 235
EPA Export 29-05-2012:04:39:42
IPPC Application Form V2/12
Summary of Emission Points at the Facility The locations of the emission points can be found in Application Form Drawing 4, Application Form Drawing 5 and Application Form Drawing 6 – Emission Points Plan in Attachment A.1. Below is a summary of the emission points from the facility.
Air A1-1 – Boiler 1. Located at the Main Plant. A1-2 – Boiler 2. Located at the Main Plant.
A2-1 – Emission Point B. Located at the Main Plant.
A3-1 – Emission Point A. Located at the Main Plant. A3-2 – Emission Point C. Located at the Main Plant. A3-3 – Emission Point S1 Located at the Stellamune Extension A3-4 – Emission Point S2 Located at the Stellamune Extension A3-5 – Domestic Boiler. Located at the QC Building A3-6 – Domestic Boiler 1. Located at the St. Colms Building. A3-7 – Domestic Boiler. Located at the SSB Building. A3-8 – Domestic Boiler 2. Located at the St. Colms Building. A3-9 – Exhaust from wash area. Located at the Main Plant. A3-10 – Minor steam or condensate emission A3-11 – Minor steam or condensate emission A3-12 – Minor steam or condensate emission A3-13 – Minor steam or condensate emission A3-14 –Bioreactor Filtered Exhaust A3-15 – Bioreactor Filtered Exhaust A3-16 – Minor steam or condensate emission A3-17 – Emergency Generator A3-18 – Compressor House Main Plant A3-19 – Recirculation Cabinet Exhaust. Located at the St. Colms Building.
Sewer SE1 – Currently known as SW1 in the IPPC/AER and located at the Main Plant SE2 – Currently known as SW2 in the IPPC/AER and located at the QC building
For inspection purposes only. Consent of copyright owner required for any other use. Noise N1 - Refrigeration compressor unit. Located at the Main Plant. N2 - S1 Fermentation. Located at the Stellamune Extension. N3 - Emergency generator. Located at the Main Plant. N4 - Chiller unit. Located at the Main Plant. N5 - Boiler house. Located at the Main Plant. N6 - HVAC Exhaust. Located at the Main Plant. N7 - Air Compressor. Located at the QC Building N8 - HVAC Exhaust. Located at the QC Building N9 - Refrigeration Unit. Located at the St. Colms Building. N10 - S1 Formulation. Located at the Stellamune Extension. N11 - S3 Fill Finish. Located at the Stellamune Extension. N12 - S4 Plantroom. Located at the Stellamune Extension. N13 - S5 Interstitial. Located at the Stellamune Extension. N14 – AHU. Located at the Stellamune Extension. N15 – AHU. Located at the Stellamune Extension. N16 – Chiller. Located at the Stellamune Extension. N17 – Condenser. Located at the Stellamune Extension. N18 – AHU. Located at the QC Building. N19 – Freezer unit. Located at the Main Plant.
Page 39 of 235
EPA Export 29-05-2012:04:39:42
IPPC Application Form V2/12
There are no emissions to surface water, groundwater or soil/ground from the facility. All waste generated on site is stored temporarily and then removed by a licensed contractor.
Control, Abatement, Recovery and Treatment Systems The following is a brief description of the control, abatement, recovery and treatment systems in place at the Elanco facility. These sections refer to the current systems being implemented on site and those which will be implemented on commencement of operations at the Stellamune extension.
The facility is currently licensed with regard to the management and monitoring of noise, air and wastewater emissions.
Emissions to Surface Water There will be no direct release of surface water from the facility including the Stellamune operations.
The surface water drainage network at each of the buildings within the Finisklin Industrial Estate drains surface water run off from hardstanding (car parking) and roof areas to the Local Authority combined drainage system. Further details on this process, is provided in the emissions to sewer section below.
Emissions to the Sewer A number of control systems are in place with regard to the management of emissions to sewer from the facility and these are detailed in the sections below.
Surface water/runoff Interceptors Surface water run off from the Main Plant (to include the Stellamune extension) and QC Building is discharged to combine with the process water at each of these buildings. This wastewater passes through an on-site oil interceptor at each location before joining the foul wastewater stream within the site boundaries. See Application Form Drawing 7 – Wastewater Structures, for the existing site drainage plan.
Oil interceptors have been installed at both the Main Plant and QC building to intercept potential spillages/leakages of fuel which may occur outside of the bunded area i.e. from car parking areas. The interceptors are both Class 2 interceptor units. The units are fitted For inspection purposes only. with an oil level probe which sendsConsent an ofalarm copyright signal owner required to a forlocation any other use. within the Main Plant and the QC Building to alert management that oil levels have reached the acceptable limit and that the unit requires a clean-out.
The flow is then directed off-site into the Local Authority combined system before discharging to Sligo’s WWTP. The WWTP provides tertiary treatment and discharges to Garovogue River Estuary.
pH Adjustment - pH Correction System – Process Wastewater (Main Plant) Process wastewater from the Main Plant is fed to a holding tank before entering the Local Authority combined system. The pH system includes a pH controller with proportional signal, pH probe and 2 dosing pumps (one for acid addition and one for base addition). The pH of the wastewater is continuously monitored. The process wastewater is neutralised by the system and in the event of an emergency non compliance pH fluctuation a signal is relayed to the discharge shut-off valve from the pH system.
This process for management of the process wastewater which serves the existing Main Plant facility will also facilitate the Stellamune extension during future operations.
Mercury Management - Collection of First Rinse (Main Plant and Stellamune Extension ) Thimerosal is an organomercurial salt chemical used at the facility as a vaccine preservative. Clean In Place (CIP) processes within the facility (existing and Stellamune)
Page 40 of 235
EPA Export 29-05-2012:04:39:42
IPPC Application Form V2/12
result in concentrations of mercury being discharged in the process wastewaters from the site to the sewer.
However, the isolation and capture at source process which is implemented on site has been estimated to reduce the levels of mercury in the CIP wastewater to low levels prior to discharge to the sewer. This process is implemented by capturing the CIP wastewater generated during the first cleaning rinse into suitable containers prior to discharge to the sewer.
Full details on the control and management of wastewater emissions with regard to mercury levels are presented in Section E.3 and are also discussed in the context of the potential for impact on receiving surface water bodies in I.2.
Monitoring of Emissions to Sewer At present, the process wastewater discharge is not treated on site, with the exception of pH adjustment at the Main Plant. However, in accordance with the current IPPC licence conditions, the discharge at the Main Plant is monitored for a number of identified parameters using a 24 hour flow proportional composite sampler, at a point downstream of the pH correction unit and prior to its discharge to foul sewer. The samples are tested on a weekly, monthly, quarterly and annual basis in accordance with the requirements of the current IPPC licence.
Additionally, at the Main Plant there is continuous monitoring of the pH, flow and temperature parameters.
At the QC building there is a chart recorder, monitoring pH and flow . If the pH level is outside the limit value of the IPPC licence (5-10 pH units), the wastewater is directed to the hazardous waste chemical stores, where it is temporarily stored before disposal via a licensed contractor.
Firewater Management No fire water retention management issues have occurred to date at the existing facility. However, a Fire Water Risk Management Study has been commissioned by Elanco in accordance with EPA Draft Guidance Note to Industry on the Requirements for Fire-Water Retention Facilities to risk assess and identify any potential requirements with regard to For inspection purposes only. firewater retention facilities/management.Consent of copyright owner required for any other use.
Stellamune extension There is a risk that in the event of a fire and in the event of a “loss of vessel integrity”, live material may be released from the Stellamune extension. A firewater sprinkler system has been designed and installed in accordance with the National Fire Protection Agency Standards including the Standard for the Installation of Sprinkler Systems, NFPA 13, 2010.
On this basis, the Stellamune extension was designed to allow potential fire water from the Stellamune manufacturing suite to be collected and decontaminated chemically before being neutralised. Firewater run-off from Containment Level two designated areas in the extension will be contained on site prior to disposal in agreement with the EPA and Local Authority.
Based on the area size of the Stellamune manufacturing suite and likely firewater run-off rates, the required firewater tank volume is calculated to be 115m 3. This includes the capacity of the largest vessel (1.5m 3) and also an additional 10% margin for safety.
Firewater run off will be collected in the Fermentation Hall and contained within the Fermentation Area by Channel Floor drains. Floor drains will be fitted with sealed covers which have a ‘pop up’ operation. The ‘pop up’ drains have a pneumatic ram fitted under the sealed cover and are activated by the Fermentation Area sprinkler flowswitch.
Page 41 of 235
EPA Export 29-05-2012:04:39:42
IPPC Application Form V2/12
Pipe specifications within the building are under the slab, double contained and are stainless steel due to the potential temperature of fire water. Externally, the pipes are underground, fully welded and single contained polypropylene.
Emissions to Atmosphere A number of control systems are in place with regard to the management of emissions to the atmosphere from the facility and these are detailed in the sections below.
Air Handling Units The AHU is a device used to condition and circulate air as part of the HVAC system.
Once the Stellamune extension is operational, the Elanco facility will have 27 Air Handling Units (AHU) serving the manufacturing areas at the Main Plant and the QC Building. This includes 24 AHU’s serving the Main Plant, 20 of which serve the existing facility and 4 of which will serve the Stellamune extension. 3 AHU’s serve the QC Building.
HVAC Systems and HEPA filters As an element of the process operations, HEPA filters are in operation at the existing Main Plant and the QC Building.
The manufacturing rooms at the Main Plant where the cultures are grown are at a negative pressure to surrounding airlocks and the air leaving these areas is filtered through the HEPA filters. The HEPA filters will contain any micro-organisms within the building in the unlikely event of a spillage from the closed system before it is disinfected. Waste, such as the HEPA filters, that is potentially infected is autoclaved out of the antigen production suite and solid waste is bagged inside ‘UN’ biohazard bags for disposal to landfill.
The current monitoring undertaken for the IPPC licence for the facility shows that the HEPA filters are effective in preventing the emission of biological agents from the facility.
Fume hood/Fume cupboard These are local ventilation devices located at the Main Plant (to include the Stellamune extension) and QC Building to limit exposure to hazardous fumes, vapours or dusts. Air is drawn in from the front (open) side, filtered and expelled outside the building via HEPA For inspection purposes only. filters. Consent of copyright owner required for any other use.
Microbiological Safety Cabinets (MBSC) These are pieces of laboratory equipment which provide a safe working area for personnel handling material which is potentially contaminated with live organisms. The MBSC’s operate using a fan mounted in the top of the cabinet to draw a curtain of sterile air over the products being handled. The air is then drawn underneath the work surface and back up to the top of the cabinet where it passes through HEPA filters which remove the live organisms.
Monitoring – Emissions to Atmosphere Elanco emits to air from a number of locations across the facility. These emission points include exhaust air from electrical rooms, air from offices and the warehouse, air from non-live areas of the Main Plant (to include the Stellamune Extension) and QC Building and air originating from live areas.
The 3 emission points at the Main Plant are currently monitored with regard to the prohibition on the presence of Production Biological Agents, particulate removal and monitoring for TA Luft Class III Organics in accordance with the requirements of the current IPPC licence.
Page 42 of 235
EPA Export 29-05-2012:04:39:42
IPPC Application Form V2/12
It is anticipated, in agreement with the Agency, that this monitoring will be extended in the new licence to include air monitoring at the 2 minor emission points at the Stellamune Extension.
Noise Emissions Monitoring The facility is located within an industrial area, and the nearest residential receptor is located approximately 0.22km to the south east.
There are a number of noise sources at the facility. The main sources are associated with chiller units, condenser units, air handling units, compressor units, HVAC exhaust and the emergency standby generator. The noise sources are largely all internal will not introduce a tonal or impulsive noise source to the existing noise climate.
In accordance with the provisions and conditions of the current IPPC licence, the emissions from the facility shall not give rise to sound pressure levels at noise sensitive locations near the activity which exceed 55dBA (Leq 15 minutes) during the daytime and 45 dBA (Leq 15 minutes) during the night time.
Attachment N o F.2 presents the Environmental Noise Measurement, Elanco Animal Healthcare Facility, Finisklin Business Park, Co. Sligo, August 2010 which assesses the noise levels from the existing facility.
Where new or replacement equipment is required, vendors are required to meet the limits of 55dBa during the day or 45dBA at night at the nearest sensitive receptor. Where this is not achievable vendors are required to provide suitable noise abatement.
Copies of the Application Form Map 2 (Site Plan) and Application Form Map 3 (Site Location Map) can be found in Attachment A.1 .
For inspection purposes only. Consent of copyright owner required for any other use.
Page 43 of 235
EPA Export 29-05-2012:04:39:42
IPPC Application Form V2/12
D.2 Development and Operational History of the Site
Development and operational history of the site
The site was established at the Finisklin Industrial Estate, Sligo in 1991, with Elanco Animal Health acquiring the site in 2010.
The initial planning permission dates from 26th November 1990, requesting the change of use of advance factory No. 3, Finisklin (Main Plant) for the manufacture of veterinary medicines and a second planning permission requesting the use of Cluster Unit 1A, Finisklin Ind. Estate as a Quality Assurance Laboratory. An Environmental Impact Statement (EIS) was attached to this permission and this document focussed on four topics; effluent, air emissions, waste disposal and noise.
There have been other smaller planning applications lodged relating to the site between 1998 and 2006. These small planning applications range from the erection of maintenance stairs and substation at the main factory to the erection of a single storey extension to provide a new entrance foyer & conference room. In accordance with the legislation, these projects did not require an Environmental Impact Assessment (EIA) to be undertaken. Further details of the planning history of the site can be found in Attachment B.5 .
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 approximately 1999, the site commenced leasing the St Colm’s facility to assist in providing sufficient warehousing, labelling and packaging facilities.
In 2006 the site also commenced leasing the “Support Service” building for office space only. It is located across the road from the Main Plant building and is referred to as the SSB Building in this application.
The activities located in the St Colm’s & SSB Building do not entail any emissions to sewer or air, which are generated from the production processes. Waste which is generated at these sites is of a general nature only. Any chemical / hazardous waste which may arise at For inspection purposes only. the St. Colm’s site would be of Consent small of volumescopyright owner and required a refor any treated other use. in accordance with the facility IPPC Licence conditions.
In 2011 construction began on the Stellamune extension to the Main Plant. The EIS submitted with the planning application identified that no significant environmental impacts were expected as a result of the construction and operation of the extension.
As of May 2012, the Stellamune extension has reached the end of the Construction phase and is entering the system handover phase from construction to commissioning. The Commissioning and Qualification of the Stellamune Facility began in the Autumn of 2011 and is scheduled to be undertaken to approximately August 2012.
This phase will be followed by the process Performance Qualification and Validation phases which are programmed to be undertaken up until mid 2013.
In advance of the Commissioning phase, Elanco have held a meeting with the sites current EPA IPPC Enforcement Officer. Elanco outlined the commissioning stage activities and submitted Commissioning Plan has been submitted to the EPA.
The EPA subsequently confirmed that the commissioning and qualification activities could proceed under the conditions of the existing IPPC licence P0090-01.
Page 44 of 235
EPA Export 29-05-2012:04:39:42
IPPC Application Form V2/12
Specific Commissioning activities will include the following:
Handover of systems from Construction to Commissioning. (This includes system Mechanical Completion, flushing, cleaning, and where applicable, passivation activities); Commissioning - static checks for installed pipe-work and/or generation capability. (No utility required); Shakedown of the utilities and energisation up to an isolation point. (Water and Air systems); Commissioning of utility systems. (Water and energisation to an isolation point); Commissioning of HVAC system (Air); Commissioning of equipment (Water & Air); and Commissioning and qualification of the automated and electrical systems.
With regard to the materials being used on site, there have been no recorded historical pollution incidents or prosecutions against the facility. Additionally, there are no recorded underground storage tanks or disused sites of waste disposal/treatment in the area and none have been identified during previous ground investigations at the facility.
For inspection purposes only. Consent of copyright owner required for any other use.
Page 45 of 235
EPA Export 29-05-2012:04:39:42
IPPC Application Form V2/12
SECTION E: EMISSIONS
This section refers to the current systems being implemented on site and those which will be implemented on commencement of operations at the Stellamune extension.
E.1. Emissions to Atmosphere
E.1.A. Details of all point emissions to atmosphere
Details of all point emissions to atmosphere should be supplied. Complete Table E.1(i) for Boiler Emissions and Table E.1(ii) and E.1(iii) for all other main emission points. Complete Table E.1(iv) for minor emission points.
Table E.1(i), E.1(ii), E.1(iii) and Table E.1(iv) have been completed.
A summary list of the emission points, together with maps and/or drawings (no larger than A3), and supporting documentation should be included as Attachment N o E . Plans of emission elevations, relevant roof heights, etc., should also be included, as should detailed descriptions and schematics of all abatement systems.
Application Form Drawing 4 , Application Form Drawing 5 and Application Form Drawing 6 the emission points plans identify the locations of the emissions to air and sewer and identifies the locations of the main noise sources is included in Attachment A.1.
The applicant should address in particular any emission point where the substances listed in the Schedule of S.I. 394 of 2004 are emitted.
For emissions outside the BAT guidance limit, a full evaluation of the existing abatement/treatment system must be provided. A planned programme of improvement towards meeting upgraded standards is required . This should highlight specific goals and a time scale, together with options for modification, upgrading or replacement as required to bring the emissions within the limits as set out in the BAT guidance note(s). These notes can be found on the EPA websiteFor inspection at purposes www.epa.ie only. . Consent of copyright owner required for any other use.
(a) Boiler Emissions (Refer to Tables E.i and E.iv) There are a number of boilers at the Elanco facility.
The main boiler house operations, located at the Main Plant, burn fuel and use water to generate steam for domestic heating, sterilising and the HVAC system operation at the Main Plant. This boiler house will also serve the Stellamune Extension.
The St.Colms building is served by two domestic boilers and the SSB Building and QC Building are each served by one domestic boiler to supply hot water and heat to the buildings. The QC Building also houses a larger boiler used to generate steam for domestic heating, sterilising and HVAC systems operation. However, as of October 2011 the steam boiler at the QC Building is out of service.
The boilers which currently service the Elanco facility are as follows:
2 Dennis Baldwin Boilers at the Main Plant (to include the Stellamune extension) to produce 3,000kg/hr of steam (2.145MW size); 1 Domestic Boiler at the QC Building (64kW size); 2 Domestic Boilers at the St.Colms building (89.5kW and 21kW size); and
Page 46 of 235
EPA Export 29-05-2012:04:39:42
IPPC Application Form V2/12
1 Domestic Boiler at the QC Building (64.5kW size)
In accordance with the Integrated Pollution Prevention and Control (IPPC) Licensing Application Guidance Notes V2/12, EPA, gas boilers over 5MW, and other fuel boilers over 250kW, should be regarded as significant. Boilers below this these sizes should be included with the minor emissions in Table E.1(iv) .
On this basis the two 3,000kg/hr Dennis Baldwin MX3000 models which are oil fired have been classified as significant and the details of the emissions have been included in Table E.1(i) . The remaining domestic boilers at the St. Colms Building, SSB Building and QC Building have been included in Table E.1(iv).
These boilers use water to generate steam for domestic heating, sterilising and HVAC operation. Low sulphur fuels, periodic preventative maintenance and best boiler-house practice are used to minimise smoke effluent and to maximise efficiency of combustion.
(b) Main Emissions and (c) Minor Emissions (Refer to Tables E.ii to E.iv) As per the IPPC Application Guidance Notes V2/12 main and minor emissions to atmosphere are categorised as follows:
“Main emissions will include all emissions of environmental significance. Where a mass emission threshold is used in the BAT Guidance Note (e.g. 3kg/h), all emissions greater than 20% of such a threshold are regarded as significant. (In some cases emissions below 20% of a threshold can still be significant and will qualify as Main Emissions.)”
The primary emission to the atmosphere from the Elanco facility is Isopropanol (Isopropyl alcohol) which is used as a disinfectant. With regard to classification of air emissions the EPA have indicated Isopropanol emissions should be classified under the Total Organic Carbon category. BAT Guidance Note for the Pharmaceutical & Other Speciality Organic Chemicals Sector, 1st edition, EPA identified the following emission levels for Total Organic Carbon as follows:
Table E.1(a) BAT Associated Emission Levels for Emissions to Air
Constituent For inspection purposes only. Emission Mass Flow Consent of copyright owner required for any other use. Group or Class Level Threshold Parameter (mg/m3) (g/hr) Not included in Class I or II Total Organic (limits set for class total) 50 500 Carbon (as C)
In order to determine if Elanco’s air emissions are main or minor the following approach has been adopted:
The 2010 emissions presented in the Elanco Annual Environmental Report to the EPA represent a typical volume of air and quantity of emissions and on this basis these figures have been taken as representative of annual emissions from the existing facility. An additional 30% has been added to the emissions to allow for possible increases in production and to represent a possible worst case scenario for emissions. A summary of the quantities of VOC emitted from the existing facility during 2010 is presented in Table E.1(b).
Page 47 of 235
EPA Export 29-05-2012:04:39:42
IPPC Application Form V2/12
Table E.1(b) Emissions to Atmosphere at Emission Points.
Calculated Emission 2010 Mass Calculated Plus Parameter mg C per Point Emissions mg per Nm3 30% Nm3* 124,283,376 Volume - - - Emission Nm 3 Point A TA Luft Class III 107 kg 0.86 0.52 0.67 Organics 230,654,304 Volume - - - Emission Nm 3 Point B TA Luft Class III 1,269 kg 5.50 3.30 4.29 Organics 140,871,312 Volume - - - Emission Nm 3 Point C TA Luft Class III 184 kg 1.31 0.79 1.02 Organics
* Isopropanol molecular formula - C 3H8O. Based on molecular weights of 12.01, 1.008 and 16.00, the carbon represents 59.95% of the total molecular weight.
Based on the information calculated in Table E.1(b) above, mass emission volumes for the existing Elanco and Stellamune Extension were calculated and are presented in Table E.1(c).
Table E.1(c) Calculated Mass Emissions
Emission Point Volume Nm3 per Calculated Mass hour* Emission Emission mg C/Nm3 Emission Point A 14,187.60 0.67 9.52g/hr Emission Point B 26,330.40 For inspection purposes only. 4.29 112.90g/hr Consent of copyright owner required for any other use. Emission Point C 16,081.20 1.02 16.46g/hr Stellamune 5,659.92 2.45 13.88g/hr Extension Point S1** Stellamune 5,659.92 2.45 13.88g/hr Extension Point S2**
* Based on the 2010 volume and based on 365 days and 24 hours per day. ** Calculated based on 20% of the total volume emitted in 2010 from Emission Points A, B and C and assuming 20% of the mass emission of Emission Points A, B and C. This 20% is based on the estimation that the Stellamune Extension process floor space is approximately 20% of the size of the process floor space of the existing facility. Figures are also estimated assuming the emissions will be evenly split between the two Stellamune Extension emission points.
Based on the BAT Mass Flow Threshold of 500g/hr, Emission Points A, C from the existing facility and the estimated emissions for Stellamune fall below 20% of the threshold and therefore have been classified as minor emission points.
Emission Point B exceeds 20% of the BAT threshold and has therefore been classified as a main emission.
Page 48 of 235
EPA Export 29-05-2012:04:39:42
IPPC Application Form V2/12
As none of the emissions fall outside of the BAT guidance limit, a full evaluation of the existing abatement/treatment system is not required to be provided.
Details of the Main Emissions (Emission Point B only) is detailed in Table E.1(ii) and Table E.1(iii).
Minor emissions to the atmosphere including the domestic boilers from the QC Building and St.Colms Building are detailed in Table E.1(iv) .
E.1.B. Fugitive and Potential emissions
Give summary details of fugitive and potential emissions in Table E.1(v).
Table E.1(v) has been completed
In relation to activities listed in the Schedule of Council Directive 1999/13/EC on the limitation of emissions of volatile organic compounds due to the use of organic solvents in certain activities and installations;
− specify the relevant category of activity in the Schedule − specify how the requirements in relation to fugitive emissions will be met.
Full details and any supporting information should form Attachment E.1.B
Attachment E.1.B is Not Applicable
Elanco’s activity is listed in Schedule of Council Directive 1999/13/EC, under the category:
Manufacturing of pharmaceutical products
The chemical synthesis, fermentation, extraction, formulation and finishing of pharmaceutical products and where carried out at the same site, the manufacture Forof inspectionintermediate purposes only. products. Consent of copyright owner required for any other use.
As the processing and testing activities do not generate aerosols, the HVAC containment system is low risk. Nevertheless, it is validated on a periodic basis and critical instrumentation is calibrated.
Elanco carries out regular sampling, analyses, measurements, examinations, maintenance and calibration at the facility. The results of the sampling and analyses are reported to the EPA in the Quarterly Environmental Reports (QER) and Annual Environmental Reporting (AER) which are a requirement of the current IPPC licence. Any abnormal results are investigated and where necessary mitigation measures are put in place to ensure there are no harmful emissions to the environment.
As part of the Preventative Maintenance Programme all equipment is inspected regularly to ensure no leaks from valve seals, pump seals or flanges are present.
With the exception from Fuel Oil, no large volume volatile substances are stored on site. Apart from Fuel Oil no large loading and unloading operations of materials take place at the site.
No solvents used in the production process and no solids which could generate dust or fugitive emissions are stored in the open.
Page 49 of 235
EPA Export 29-05-2012:04:39:42
IPPC Application Form V2/12
Chemicals in use at the facility are stored in dedicated containers or storage tanks. Storage containers and tanks are bunded to retain the contents in the event of a spill. Chemicals are segregated according to their individual properties and individual storage requirements. Volumes of materials are relatively small and no materials are stored in quantities likely to pose a hazard or endanger the environment.
Emissions are created through the use of Isopropanol (IPA) to sanitise the manufacturing environment. Elanco have surface wipe down procedures in place, which outline the steps required for wiping down workstations and equipment as well as the steps required for introducing new equipment into the process areas. All areas where IPA is used and will be used at the Stellamune extension are served by HVAC/HEPA systems.
These emissions to atmosphere are monitored currently at three points in the Main Plant to ensure compliance with the conditions of the current IPPC licence. Refer to Section E.1 , Table E.1(ii), Table E.1(iii) and Table E.1(iv) for relevant details.
As there are no odour releasing issues with any of the materials used in the facility, it is expected that there will be a negligible release of odour to the environment.
E.2 Emissions to Surface Waters
Tables E.2(i) and E.2(ii) should be completed.
Tables E.2(i) and E.2(ii) are not applicable.
summary list of the emission points, together with maps/drawings (no larger than A3) and supporting documentation should be included as Attachment N o E.2 .
The applicant should address in particular any emission point where the substances listed in the Schedule of S.I. No. 394 of 2004 are emitted.
Details of all List I and List II substances listed in the Annex to EU Directive 76/464/EEC (as amended), contained in any emission must be presented. All surface water runoff and storm water drains discharging to surface water bodies must be included. A National For inspection purposes only. Grid References (12 digit, 6E, 6N)Consent must of copyright be ownergiven required for for all any dischargeother use. points. The identity and type of receiving water (river, ditch, estuary, lake, etc.) must be stated.
Details of all substances listed in the European Communities Environmental Objectives (Surface Waters) Regulations 2009, contained in any emission must be presented. All surface water runoff and storm water drains discharging to surface water bodies must be included. A National Grid Reference (12 digit, 6E, 6N) must be given for all discharge points the identity and type of receiving water (river, ditch, estuary, lake, etc.) must be stated
For emissions outside the BAT guidance limit, a full evaluation of the existing abatement/treatment system must be provided. A planned programme of improvement towards meeting upgraded standards is required . This should highlight specific goals and a time scale, together with options for modification, upgrading or replacement as required to bring the emissions within the limits as set out in the BAT guidance note(s).
E.2 Emissions to Surface Waters is not applicable.
Page 50 of 235
EPA Export 29-05-2012:04:39:42
IPPC Application Form V2/12
E.3 Emissions to Sewer
Tables E.3(i) and E.3(ii) should be completed.
Tables E.3(i) and E.3(ii) have been completed.
A summary list of the emission points, together with maps and/or drawings (no larger than A3) and supporting documentation should be included as Attachment N o E.3 . Details of all List I and List II substances listed in the Annex to EU Directive 2006/11/EC (as amended), contained in any emission must be presented. All relevant information on the receiving sewer , including any effluent treatment/abatement systems, not already described, with schematics as appropriate should also be included in Attachment N o E.3.
For emissions outside BAT guidance limit (where given), a full evaluation of the existing abatement/treatment system must be provided. A planned programme of improvement towards meeting upgraded standards is required . This should highlight specific goals and a time scale, together with options for modification, upgrading or replacement as required to bring the emissions within any limits set out in the BAT guidance note(s).
Details of the emissions to sewer can be found in Table E.3(i) and Table E.3(ii).
Application Form Drawing 4, Application Form Drawing 5 and Application Form Drawing 6 are presented in Attachment A.1 showing the location of the sewer emission points.
A schematic showing the drainage of Thimerosal using processes is included in Attachment E.3.
Process wastewater, including Clean in Place (CIP) liquid waste is directed to foul sewer.
The flow is then directed off-site into the Local Authority combined system before discharging to Sligo’s WWTP. The WWTP provides tertiary treatment and discharges to Sligo Harbour Estuary.
Emission Points For inspection purposes only. In total, there are currently twoConsent emission of copyright points owner requiredto sewer for any otherfrom use. the facility. There are no proposed additional emissions points required as part of this Application.
Within the Application the 2 emission points have been referenced as follows:
Current Emission Point Reference No: SW1 (Proposed emission point SE1 ) Emission Type: Discharge from Main Plant; and Current Emission Point Reference No. SW2 (Proposed emission point SE2 ) Emission Type : Discharge from Quality Control Building
The current Emission Point Reference No: SW1 (Proposed emission point SE1 ) is located at the Main Plant and will receive the wastewater from the Stellamune Extension.
List I and List II Substances With regard to the list I and List II substances listed in the Annex to EU Directive 2006/11/EC and the pollutants listed in the Schedule of the EPA (Licensing) (Amendment) Regulations 2004 (S.I. No. 394 of 2004, following assessment of site processes and materials, the tables below present the materials in wastewater onsite which are List I and List II substances.
Page 51 of 235
EPA Export 29-05-2012:04:39:42
IPPC Application Form V2/12
List I Substances
List I group/family Potential Presence in Wastewater Organohalogen compounds and Not present substances which may form such compounds in the aquatic environment Organphosphorus compounds Not present Substances in respect of which it has Utilised on site and potentially present in been proved that they possess process wastewater in trace quantities. carcinogenic properties in or via the aquatic environment (where certain substances on List II are carcinogenic, they are included in category 4 of this list), Mercury and its compounds, Present Cadmium and its compounds, Not present Persistent mineral oils and hydrocarbons Potentially present. However oil of petroleum origin, interceptors are located at the Main Plant and the QC Building to remove potential oil prior to discharge to the sewer. Persistent synthetic substances which Suspended solids present and may float remain in suspension or sink monitored. and which may interfere with any use of the water.
List II Substances:
List II group/family Potential Presence in Wastewater The following metalloids and metals and their Unlikely to be present compounds: 1. Zinc 6. Selenium 11. Tin 16.Vanadium For inspection purposes only. 2. 7. Arsenic 12.Consent of copyright17. owner Cobalt required for any other use. Copper Barium 3. 8. Antimony 13. 18. Thallium Nickel Beryllium 4. 9. 14. 19. Chrome Molybdenum Boron Tellurium 5. Lead 10. Titanium 15. 20.Silver
Biocides and their derivatives not appearing in list I Utilised on site and potentially present in process wastewater in trace quantities. Substances which have a deleterious effect on the Detergents and fuel oil are taste and/or smell of the products for human potentially present. consumption derived from the aquatic environment, Toxic or persistent organic compounds of silicon, Utilised on site and potentially and substances which may give rise to such present in process wastewater compounds in water, excluding those which are in trace quantities. biologically harmless or are rapidly converted in water into harmless substances Inorganic compounds of phosphorus and elemental Not present
Page 52 of 235
EPA Export 29-05-2012:04:39:42
IPPC Application Form V2/12
List II group/family Potential Presence in Wastewater phosphorus Non persistent mineral oils and hydrocarbons of Potentially present. However petroleum origin, oil interceptors are located at the Main Plant and the QC Building to remove potential oil prior to discharge to the sewer. Cyanides, Fluorides Not present Substances which have an adverse effect on the Ammoniacal Nitrogen and oxygen balance, particularly: ammonia, nitrites Kjeldahl Nitrogen are monitored in accordance with the current IPPC Licence.
Emissions Management In accordance with current licence conditions, weekly, monthly, quarterly and annual 24 hour composite samples are taken from SW1 by EHS personnel. The SW1 sample is sent to the St.Colms Building to be packaged and shipped to the contract laboratory. Emission Point SW2 is sampled if there is a flow of effluent from this emission point. Effluent samples at SW2 are taken by means of a grab sample by EHS personnel. It is noted that due to the intermittent nature of the flow from this emission point and to ensure compliance with the IPPC Licence conditions, it is proposed to undertake a design/technical review during the summer of 2012, with regard to the volume and quality of the discharge to the sewer. The recommendations of this review will be implemented on site to confirm that any discharges are managed appropriately and have minimum impact on the sewer. pH is monitored in situ at both the Main Plant and at the QC Building. In the event that the pH level is outside the limit value of the IPPC licence, measures are taken to either correct the pH (Main Plant) or to direct the wastewater to the hazardous waste chemical stores (QC Building).
Oil interceptors have been installed at the Main Plant and QC building to intercept potential spillages/leakages of fuel which For inspection may occupurposesr only.outside of the bunded area i.e. from car parking areas. Consent of copyright owner required for any other use.
Further details on the pH correction system at the Main Plant, the pH monitoring at the QC Building and the Oil interceptors are included in Section D of the Application.
Mercury and its compounds (Main Plant –SE1) Thimerosal is used at the Main Plant as a vaccine preservative. No primary materials containing mercury are discharged from the facility. However, the Clean In Place (CIP) process within the facility results in very low concentrations of mercury being discharged in the process wastewaters from the site to the Local Authority combined sewer.
Mercury is included as a List I dangerous substance under the Dangerous Substances Directive (2006/11/EC).
Directive 2008/105/EC, of 16th December 2008, on Environmental Quality Standards (EQS) in the field of Water Policy sets a mercury environmental quality standard of 0.05microg/l, as an annual average and 0.07microg/l as a maximum allowable concentration (MAC). This would apply to the impact of the combined emissions from the agglomeration of Sligo WWTP discharge plus natural background levels in the external environment.
Page 53 of 235
EPA Export 29-05-2012:04:39:42
IPPC Application Form V2/12
On this basis, a detailed assessment was undertaken by Elanco to assess the potential impact of emissions containing mercury on the environment. The included Irish Hydrodata ( Attachment I.2 ) modelling and the associated mass balances take all inputs into consideration on a worst case basis to demonstrate the impact on the receiving environment.
An isolation and capture at source process of the CIP wastewaters is implemented on site and it has been estimated that this process reduces the levels of mercury in the CIP wastewater by 99.87% prior to discharge to the Local Authority combined sewer and subsequently the Sligo WWTP.
This process is implemented by capturing the CIP wastewater generated during the first cleaning rinse into suitable containers..
The wastewater material collected from the first rinse during this cleaning process is then transported for off site disposal by appropriately licensed waste contractors.
With the effective implementation of this capture at source process, it has been determined that only 22.7grams of mercury will be discharged from the Main Plant (SE1) to the sewer and Sligo WWTP each year. Although detailed information on the mercury content of other discharges to the Sligo WWTP was not available, it is estimated that this figure is in the region of 492 grams per year.
Please refer to Tables E.3 for predicted concentrations details of mercury from SE1.
Detailed modelling assessments were undertaken with regard to the final surface water receiving body (Garvogue River Estuary) and also with the management of sludge which is generated at the WWTP. These aspects are discussed in Section I.2 and H.2 of the Application respectively.
A schematic showing the drainage of Thimerosal using processes is included in Attachment E.3.
E.4 Emissions to Ground
For inspection purposes only. Describe the existing or proposedConsent arrangements of copyright owner nece requiredssary for any to other give use. effect to Council Directive 80/68/EC on the protection of groundwater against pollution by certain dangerous substances.
The applicant should supply details of the nature and quality of the substance (agricultural and non-agricultural waste) to be landspread (slurry, effluent, sludges etc) as well as the proposed application rates, periods of application and mode of application (e.g., pipe discharge, tanker) having regard to, European Communities (Good Agricultural Practice for Protection of Waters) Regulations 2009, S.I. No 101 of 2009.
For emissions outside the BAT guidance limit, a full evaluation of the existing abatement/treatment system must be provided. A planned programme of improvement towards meeting upgraded standards is required . This should highlight specific goals and a time scale, together with options for modification, upgrading or replacement as required to bring the emissions within the limits as set out in the BAT guidance note(s).
Emissions to Ground is not applicable.
Page 54 of 235
EPA Export 29-05-2012:04:39:42
IPPC Application Form V2/12
E.5 Noise Emissions
Give particulars of the source, location, nature, level, and the period or periods during which the noise emissions are made or are to be made.
Table E.5 (i) should be completed, as relevant, for each source.
Table E.5 (ii) has been completed.
Supporting information should form Attachment N o E.5
Attachment A.1 presents Application Form Drawing 4, Application Form Drawing 5 and Application Form Drawing 6 identifying noise emission locations .
For emissions outside the EPA Guidance Note for Noise in Relation to Scheduled Activities 2nd Edition (2006), a full evaluation of the existing abatement/treatment system must be provided. A planned programme of improvement towards meeting upgraded standards is required . This should highlight specific goals and a time scale, together with options for modification, upgrading or replacement as required to bring the emissions within the limits as set out in the Guidance Note.
The facility is located within an industrial area and the nearest residential receptor is located approximately 0.22km to the south east.
There are a number of noise sources at the facility located at the Main Plant and QC Building. These noise sources are primarily associated with the chiller units, condenser units, air handling units, compressor units, HVAC exhaust and a standby generator (Main Plant).
In accordance with the provisions and conditions of the current IPPC licence, the emissions from the facility shall not give rise to sound pressure levels at noise sensitive locations near the activity which exceed 55dBA (Leq 15 minutes) during the daytime and 45 dBA (Leq 15 minutes) during the night time.The noise sources are largely all internal will not introduce a tonal or impulsive noise source to the existing noise climate.
For inspection purposes only. Where new or replacement equipmentConsent of copyright is required, owner required vend for any orsother use. are required to meet the limits of 55dBa during the day or 45dBA at night at sensitive locations near the activity. Where this is not achievable vendors are required to provide suitable noise abatement.
Details of the noise emissions from the facility can be found in Table E.5(i).
E.6 Tabular Data on Emission Points
Applicants should submit the following information for each emission point:
Point Point Type Easting Northing Verified Emission Code
Provide A=Atmospheric 6E-digit GPS 6N-digit GPS Y = GPS e.g. SO 2, label ID’s SW=Surface Water Irish Irish used HCl, NH 3 assigned SE = Sewer National National N = GPS in section GW=Groundwater Grid Grid not used E N = Noise Reference Reference SL=Soil/Ground WS=Waste
Page 55 of 235
EPA Export 29-05-2012:04:39:42
IPPC Application Form V2/12
An individual record (i.e. row) is required for each emission point. Acceptable file formats include Excel, Access or other upon agreement with the Agency. A standard Excel template can be downloaded from the EPA website at www.epa.ie. This data should be submitted to the Agency on a separate CD-Rom containing sections B.2, E.6 and F.3.
This information relating to the emission points for the facility are presented in Attachment E.6.
For inspection purposes only. Consent of copyright owner required for any other use.
Page 56 of 235
EPA Export 29-05-2012:04:39:42
IPPC Application Form V2/12
SECTION F: CONTROL & MONITORING
This section refers to the current systems being implemented on site and those which will be implemented on commencement of operations at the Stellamune extension.
Describe the proposed technology and other techniques for preventing or, where this is not possible, reducing emissions from the installation/facility.
F.1: Treatment, Abatement and Control Systems
Details of treatment/abatement systems (air and effluent emissions) should be included, together with schematics as appropriate.
For each Emission Point identified complete Table F.1(i) and include detailed descriptions and schematics of all abatement systems.
Table F.1(i) has been completed.
Attachment N o F.1 contains supporting information.
Air Emissions
Air Handling Units – HVAC Systems The HVAC systems are present in the Main Plant and QC Building are designed to maintain cleanroom, sterile conditions for processing and testing purposes; control of working conditions regarding humidity and temperature; and containment of biological agents.
As the processing and testing activities do not generate aerosols, the HVAC containment system is low risk. Nevertheless, it is validated on a periodic basis and critical instrumentation is calibrated.
In the Main Plant, the HVAC system is also capable of controlling high temperature and humidities for fumigation purposes. For inspection purposes only. Consent of copyright owner required for any other use.
Sub-micron Filtration Systems Sub-micron filtration systems for bioreactor off-gas are designated primarily to protect the manufacturing process from contamination, but act also to provide high levels of environmental protection due to effectively containing the biological agents.
HEPA Filters As an element of the process operations, HEPA filters are in operation at the facility at the Main Plant (to include the Stellamune Extension) and the QC Building to capture particulate emission and biological agents.
The manufacturing rooms in the suite where the cultures are grown are at a negative pressure to surrounding airlocks and the air leaving these areas is filtered through the HEPA filters. These will contain the micro-organisms within the building in the unlikely event of a spillage from the closed system, this spill will remain within the area before it is disinfected.
Monitoring of air emissions undertaken for the IPPC licence, shows that the HEPA filters are effective in preventing the emission of biological agents from the facility. Refer to monitoring results in Elanco AER’s in Attachment N o C.1 and Tables E.1 (iii) and E.1 (iv) .
Page 57 of 235
EPA Export 29-05-2012:04:39:42
IPPC Application Form V2/12
At the main process emissions points, a prohibition on the presence of Production Biological Agents is applied and monitored under the IPPC licence for the facility. This prohibition covers the presence of bacteria, virus or Genetically Modified Organisms which are used in the processes.
Fume hood / Fume cupboard These are local ventilation devices to limit exposure to hazardous fumes, vapours or dusts located in the Main Plant (to include the Stellamune Extension) and QC Building. Air is drawn in from the front (open) side, HEPA filtered and expelled outside the building. Fume hoods and fume cupboards are used throughout the Main Plant, Stellamune Extension and the QC Building.
Microbiological Safety Cabinets (MBSC) These items of laboratory equipment which provide a safe working area for personnel handling material which is potentially contaminated with live organisms. The MBSC’s operate using a fan mounted in the top of the cabinet to draw a curtain of sterile air over the products being handled. The air is then drawn underneath the work surface and back up to the top of the cabinet where it passes through HEPA filters which remove the live organisms.
Further details of treatment/abatement control and the emissions monitoring and sampling point can be found in Table F.1(i).
Emissions to Sewer Process wastewater will be generated at the Main Plant and also at the QC Building. Specific details on the quantity and nature of the wastewater emissions are identified in Section E .
No process based emissions are generated or discharged from the warehousing or administration facilities.
Please refer to Application Form Drawing 7 – Wastewater Structures in Attachment A.1 for the existing site drainage plan.
For inspection purposes only. The abatement, control and treatmentConsent of copyright processes owner required in for p anylace other at use. the Main Plant and QC Building with regard to wastewater emissions are detailed below. pH Adjustment - pH Correction System – Process Wastewater (Main Plant) Process wastewater from the Main Plant is fed to a holding tank before entering the Local Authority combined sewer. The pH system includes a pH controller with proportional signal, pH probe and 2 dosing pumps (one for acid addition and one for base addition). The pH of the wastewater is continuously monitored. The process wastewater is neutralised by the system and in the event of an emergency non compliance pH fluctuation a signal is relayed to the discharge shut-off valve from the pH system.
This process for management of the process wastewater which serves the existing Main Plant facility will also facilitate the Stellamune extension during future operations.
The pH of the wastewater from the Main Plant is continuously monitored using this system. If the pH limit value of the IPPC licence is exceeded, a signal will be relayed to the discharge shut-off valve from the pH system. pH Management – QC Building At the QC Building, if the pH level is outside the limit value of the IPPC licence (5-10 pH units), the wastewater is directed to the hazardous waste chemical containers, where it is temporarily stored before disposal via a licensed contractor.
Page 58 of 235
EPA Export 29-05-2012:04:39:42
IPPC Application Form V2/12
Surface water/runoff Interceptors The surface water run off from the Main Plant and QC Building is discharged to combine with the process water (following pH monitoring/correction) at each building. This wastewater then passes through the on-site oil interceptor before joining the foul water waste stream within the site boundaries.
Oil interceptors have been installed at the Main Plant and QC building to intercept potential spillages/leakages of fuel which may occur outside of the bunded area i.e. from car parking areas. The interceptors are both Class 2 interceptor units. The units are fitted with an oil level probe which sends an alarm signal to a location within the Main Plant and the QC Building to alert management that oil levels have reached the acceptable limit and that the unit requires a clean-out.
The flow is then directed off-site into the Local Authority combined system before discharging to Sligo’s WWTP. The WWTP provides tertiary treatment and discharges to Garovogue Harbour Estuary.
Mercury Management The isolation and capture at source process which is implemented on site with regard to Thimerosal (organomercurial salt) has been estimated to reduce the levels of mercury in the CIP wastewater to low levels prior to discharge to the Local Authority combined sewer.
This process is implemented by capturing the CIP wastewater generated during the first cleaning rinse into suitable containers for off-site disposal.
Full details are provided in Section E .
Emission to Sewer Monitoring In accordance with the current IPPC licence conditions, the discharge at the Main Plant is monitored for a number of identified parameters using a 24 hour flow proportional composite sampler, at a point downstream of the pH correction unit and prior to its discharge to foul sewer. The samples are tested on a weekly, monthly, quarterly and annual basis in accordance with the requirements of the current IPPC licence. For inspection purposes only. Consent of copyright owner required for any other use. Additionally, at the Main Plant there is continuous monitoring of the pH, flow and temperature parameters.
At the QC building there is a chart recorder, monitoring pH and flow.
In accordance with the current licence, there are also monitoring requirements with regard to SW2 (proposed SE2) at the QC building for a number of parameters.
Firewater Retention / Management No fire water retention management issues have occurred to date at the existing Elanco facility. However, a Fire Water Risk Management Study has been commissioned by Elanco in accordance with EPA Draft Guidance Note to Industry on the Requirements for Fire-Water Retention Facilities to risk assess and identify any potential requirements with regard to firewater retention facilities/management. The results of this study are expected to be available in Summer 2012.
The IPPC Licence contains monitoring requirements and conditions for emission to sewer.
The study will involve, but is not limited to, reviewing the process activities on site, the materials stored on site, their location and the maximum quantities stored on site. The foul and surface water layouts, disposal locations and effluent limits, the list and location
Page 59 of 235
EPA Export 29-05-2012:04:39:42
IPPC Application Form V2/12 of fire abatement equipment on site, the total volume of firewater stored on site, emergency response procedures, and correspondence with the local fire fighting unit will also be reviewed.
Based on a review of the information firewater risk assessments will be carried out on each relevant area of the site which will include:
Identification of hazards; Identification of control measures; Probability of incident occurring; and Impact of the incident.
Stellamune extension There is a risk that in the event of a fire and in the event of a “loss of vessel integrity”, live material may be released from the Stellamune extension. A firewater sprinkler system was designed and installed in accordance with the National Fire Protection Agency Standard including the Standard for the Installation of Sprinkler Systems.
On this basis, the extension was designed to allow potential fire water from the Stellamune manufacturing suite to be collected and decontaminated chemically before being neutralised. Firewater run-off from Containment Level Two designated areas in the extension will be contained on site prior to disposal in agreement with the EPA and Local Authority.
Based on the area size of the Stellamune manufacturing suite and likely firewater run-off rates, the required firewater tank volume is calculated to be 115m 3. This includes the capacity of the largest vessel (1.5m 3) and also an additional 10% margin for safety.
Firewater run off will be collected in the Fermentation Hall and contained within the Fermentation Area by Channel Floor drains. Floor drains will be fitted with sealed covers which have a ‘pop up’ operation. The ‘pop up’ drains have a pneumatic ram fitted under the sealed cover and are activated by the Fermentation Area sprinkler flowswitch.
Pipe specifications within the building are under the slab, double contained and are stainless steel due to the potential temperature For inspection purposes of fire only. water. Externally, the pipes are Consent of copyright owner required for any other use. underground, fully welded and single contained polypropylene.
Further details of treatment/abatement control and the emissions monitoring and sampling points can be found in Table F.1(i).
Attachment N o F.1 should contain any supporting information. No supporting information required to be submitted.
Page 60 of 235
EPA Export 29-05-2012:04:39:42
IPPC Application Form V2/12
F.2: Emissions Monitoring and Sampling Points
Identify monitoring and sampling points and outline proposals for monitoring emissions . Table F.2(i) should be completed (where relevant) for air emissions, for emissions to surface waters, for emissions to sewers, for emissions to ground, and for waste emissions. Where ambient environment monitoring is carried out or proposed, Table F.2(ii) should be completed as relevant for each environmental medium.
Include details of monitoring/sampling locations and methods.
Elanco carries out sampling, analyses, measurements, examinations, maintenance and calibration at the facility. The results of the sampling and analyses are reported to the EPA in the Quarterly Environmental Reports (QER) and Annual Environmental Reporting (AER) which are a requirement of the current IPPC licence.
This reporting includes details on and the results of the monitoring of emissions to atmosphere and sewer and also noise emissions monitoring. The AERs from 2008 – 2011 are presented in Attachment N oC.1 .
There are no direct discharges to surface water and no discharges to groundwater from the Elanco facility.
Application Form Drawing 4, Application Form Drawing 5 and Application Form Drawing 6 in Attachment A.1 identifies the monitoring locations of emissions to atmosphere, sewer and noise.
Please refer to Tables F.2 (i) for details of monitoring parameters, frequency, sampling method and analysis technique.
Emissions to Atmosphere - Monitoring Points The current emission points reference numbers are:
A3-1: A-HVAC/HEPA Filtered Air A2-1: B-HVAC/HEPA Filtered Air For inspection purposes only. A3-2: C-HVAC/HEPAConsent Filteredof copyright ownerAir required for any other use.
The Stellamune Extension has 2 additional proposed emission points, referenced as:
A3-3: S1-HVAC/HEPA Filtered Air A3-4: S2-HVAC/HEPA Filtered Air
Currently for three air emission points at the existing facility, a prohibition on the presence of Production Biological Agents is applied and monitored under the IPPC licence for the facility. This prohibition covers the presence of bacteria, virus or GMOs which are used in the processes.
These air emission points are also currently monitored on a quarterly basis for TA Luft Class III Organics in accordance with the requirements of the IPPC licence – Schedule 1(i). Particulate removal is also monitored for either biannually or on re-validation.
It is noted that the original licence contains a provision for monitoring of formaldehyde in air emissions. Correspondence issued from Elanco in 2003 (Fort Dodge at the time) confirmed that formaldehyde has been discontinued as a fumigant and that its reintroduction shall not take place without prior notification to the Agency. On this basis, formaldehyde is not currently monitored in air emissions.
Page 61 of 235
EPA Export 29-05-2012:04:39:42
IPPC Application Form V2/12
The emissions to atmosphere are reported in the facilities AER. Copies of the AERs for 2008, 2009, 2010 and 2011 are included in Attachment No. C.1.
It is anticipated, but in agreement with the Agency, that the same monitoring requirements will be applied to the 2 additional minor emission points at the Stellamune extension.
It is also noted and as discussed in more detail in Section E, emissions from Isopropanol have been reclassified from the current TA Luft Class III Organics category to the Total Organic Carbon category.
Elanco have developed a Calibration and Use of the SKC Universal Air Sampling Pump (SOP 01-034-00). The procedure outlines how the SKC Universal Sampling pump is calibrated and used for taking samples for emissions to atmosphere monitoring.
Wastewater Emissions – Sampling Points The sampling locations for wastewater emissions are: Emission Point Reference No: SW1 (Proposed emission point SE1 ) Emission Type: Discharge from Main Plant (to serve the existing facility and future Stellamune extension)
Emission Point Reference No. SW2 (Proposed emission point SE2 ) Emission Type: Discharge from Quality Control Building
Elanco have developed a Sampling and Analysis of Effluent Discharge from Emission Point SW1 (Main Plant) and Emission Point SW2 (Quality Control Building) SOP (SOP 01-050- 01). This SOP is developed to ensure compliance with the provisions of the current IPPC licence.
In accordance with current IPPC Licence provisions, samples are currently monitored for the following parameters:
Outlet Flow (continuous); BOD and COD (monthly and weekly); pH (continuous); For inspection purposes only. Suspended Solids Consent(weekly); of copyright owner required for any other use. Total Phosphorous (quarterly); Total Kjeldahl Nitrogen (quarterly); Total Ammonia (quarterly); Formaldehyde (SW1 only); Effluent Toxicity (annually); and Temperature (weekly).
It is proposed to continue to monitor at Emission Point SW1 and Emission Point SW2 for these parameters, subject to agreement with the Agency.
With regard to levels of mercury in the wastewater discharged from the Main Plant (SE1), it is proposed, in agreement with the Agency, that monthly monitoring of 24 hour flow proportional composite samples to monitor the mercury levels will be undertaken.
The SOP describes the steps involved in the collection, storage, labelling, transport and analysis of effluent samples from Elanco and receipt of effluent test results from Bord Na Mona Ltd. Any changes to the parameters or the sampling frequency as a result of the IPPC licence review will be incorporated into the SOP.
Page 62 of 235
EPA Export 29-05-2012:04:39:42
IPPC Application Form V2/12
Sample Location SW1 (proposed SE1) Currently the pH and temperature of samples from Emission Point SW1 are recorded daily by the Engineering Department. If any of the readings are outside the limits specified then a photocopy of the record is sent for the attention of the EHS Officer on the same day that the reading was taken.
Additionally, weekly samples are also taken from SW1 (24hr flow proportional composite samples) by EHS personnel. The SW1 sample is sent weekly to the St.Colms Building to be packaged and shipped to the contract laboratory for analysis on the range of parameters identified above.
When the sample is collected from the composite sampler at SW1 the sample pump tubing is examined for wear and replaced (if required) as per the operator’s manual. Spare tubing and the operator’s manual for the composite sampler are kept in the Engineering Stores and Elanco library respectively. If, for any reason, the sampler is not working a service engineer is called immediately to carry out repairs to the sampler. An EHS deviation record is raised. A flow proportional composite sample is taken as soon as is practicable following repair of the sampler.
With regard to levels of mercury in the wastewater discharged from the Main Plant (SW1), it is anticipated, in agreement with the Agency, that monthly monitoring of 24 hour flow proportional composite samples to monitor the mercury levels will be undertaken.
A flow diagram providing an overview of the wastewater stream from the Main Plant is provided in Attachment F.2.
Sample Location SW2 (proposed SE2) Sampling from Emission Point SW2 is only sampled if there is a sufficient flow of effluent from this emission point. It is noted that due to the intermittent nature of the flow from this emission point and to ensure compliance with the IPPC Licence conditions, it is proposed to undertake a design/technical review during the summer of 2012, with regard to the volume and quality of the discharge to the sewer. The recommendations of this review will be implemented on site to confirm that any discharges are managed appropriately and have minimum impact on the sewer. For inspection purposes only. Consent of copyright owner required for any other use. Effluent samples from emissions point SW2 are taken at the side of the QC building by QC personnel. Access to the effluent requires the lifting of a manhole cover.
Effluent samples at SW2 are taken by means of a grab sample. A clean plastic container i.e. Beaker with a rope/holding rod attached will be used to grab effluent from SW2. The sampling container is rinsed several times using the effluent water immediately prior to sampling.
It is proposed that mercury containing wastes generated at the QC building will be stored in dedicated waste container prior to off site disposal by a licenced waste contractor. No such wastes will be discharged to the sewer.
A flow diagram outlining the wastewater stream from the Quality Control Laboratory is provided in Attachment F.2.
Noise Emission Monitoring Points In accordance with the provisions and conditions of the current IPPC licence, the “emissions from the activity shall not give rise to sound pressure levels (LAeq 15 minutes) at noise sensitive locations near the activity which exceed the limit values specified”.
Page 63 of 235
EPA Export 29-05-2012:04:39:42
IPPC Application Form V2/12
There are no noise sensitive locations in the immediate vicinity of the Elanco facility with the nearest residential estate located 0.22km to the south east (Rathedmond Estate). Based on the levels recorded at the Elanco boundary positions, it is considered that the site is operating in compliance with the requirements of the EPA IPPC licence.
The limits specified in the licence are 55 dBA (Leq 15 minutes) during the daytime and 45 dBA (Leq 15 minutes) during the night-time at the nearest noise sensitive location.
In addition, the IPPC licence requires that a noise survey of the site operations is undertaken every 3 years. The latest noise measurement survey was undertaken in June 2010 by Elanco. Noise measurements were taken at 14 measurement locations. These measurement locations included measurements at the Main Plant, QC Building, St.Colms building and at the Rathedmond Residential Estate (the nearest residential receptor).
It is anticipated and in agreement with the Agency that noise monitoring surveys will continue to be undertaken at the site every 3 years.
Attachment N o F.2 should contain any supporting information.
A copy of the report Environmental Noise Measurement, Elanco Animal Healthcare Facility, Finisklin Business Park, Co. Sligo, August 2010 is included in Attachment F.2 .
Emissions to Ground is not applicable.
F.3: Tabular Data on Monitoring and Sampling Points
Applicants should submit the following information for each monitoring and sampling point:
Point Point Type Easting Northing Verified Pollutant Code
Provide M=Monitoring 6E-digit 6N-digit Y = GPS used e.g. SO 2, label ID’s S=Sampling GPS Irish GPS Irish N = GPS not HCl, NH 3 assigned National National used in section Grid Grid For inspection purposes only. F3 ReferenceConsent of copyright Referenceowner required for any other use.
An individual record (i.e. row) is required for each monitoring and sampling point. Acceptable file formats include Excel, Access or other upon agreement with the Agency. A standard Excel template can be downloaded from the EPA website at www.epa.ie . This data should be submitted to the Agency on a separate CD-Rom containing sections B.2, E.6 and F.3.
Point source monitoring/sampling refers to monitoring from specific emission points (e.g. from a boiler stack or outlet from a wastewater treatment plant). Examples of ambient monitoring includes monitoring of ambient air quality (e.g. boundary or off-site) or monitoring of river quality upstream/downstream of an effluent discharge.
This information relating to the existing emissions points and those relating to the Stellamune extension is presented in Attachment F.3.
Page 64 of 235
EPA Export 29-05-2012:04:39:42
IPPC Application Form V2/12
SECTION G: RESOURCE USE AND ENERGY EFFICIENCY
G.1 Give a list of the raw and ancillary materials, substances, preparations, fuels and energy which will be produced by or utilised in the activity.
A comprehensive list with full details of the raw and ancillary materials, substances, preparations, fuels and energy utilised at the facility and including future materials from the Stellamune extension are provided in Table G.1(i) and Table G.1(ii). In relation materials for new products these have been included insofar as is possible. For some new materials suppliers have not yet been identified and Material Safety Data Sheets are not yet available. These items have been identified in the Tables.
The list classifies the materials in accordance with Article 2 of these EU (Classification, Packaging, Labelling and Notification of Dangerous Substances) Regulations 1994 [SI 77/94] and specifies the designated Risk Phrases (R-Phrases) of each relevant substance in accordance with Schedule 2 of these Regulations
The raw and auxiliary materials used at the facility are classified in the following categories: production and manufacturing raw materials, pharmaceutical ingredients, laboratory chemicals and cleaning materials.
Additional materials used at the facility include packaging, maintenance materials and fuel oil.
All materials delivered to Elanco are received at the St.Colm’s building. Deliveries of raw materials and equipment are quality checked prior to release for controlled use at other areas of the facility. Volumes of materials are relatively small and no materials are stored in quantities likely to pose a hazard or endanger the environment.
For smooth and continuous operation of the production units, raw materials, intermediates and finished products are stocked in storage facilities interspersed in the facility appropriate for the nature of the product stored. These storage areas include locked chemical cabinets, cold rooms, freezer rooms, fridges and warehouse areas. For inspection purposes only. Consent of copyright owner required for any other use. Materials are also generally stored only in volumes required for manufacturing and are not reordered until the quantities stored reach a low level.
The key areas of material storage at the facility have been identified on Application Form Drawing 8 , Application Form Drawing 9 and Application Form Drawing 10 included in Attachment A.1.
G.2 Energy Efficiency
Energy
Energy Management As detailed in Section C, Elanco implement a programme of environmental management at the facility. As part of this programme, Elanco implement a programme of continuous improvement on site with regard to environmental performance and this programme is also integrated with Elanco’s commitment to responsible energy management.
There are a variety of energy management and reduction programmes ongoing at the facility with ongoing plans to continuously review and improve the level of energy usage being consumed.
Page 65 of 235
EPA Export 29-05-2012:04:39:42
IPPC Application Form V2/12
Energy management is currently included as part of the environmental management programme to ensure that relevant objectives are set and performance is measured.
A copy of the Energy Policy for the facility is included in Attachment No C.1 .
Energy Provision Energy used at the facility is provided by both light fuel oil and electricity.
Electricity The consumption levels of light fuel oil, electricity and also mains water are monitored and reported in the facility’s Annual Environmental Report in accordance with current IPPC licence requirements.
The facility’s electrical supply is currently served by a connection to the existing ESB 10 kV electricity supply system. The highest measured maximum demand (MD) is recorded at 693kVA or 1054 Amps at 380V. The contracted maximum import capacity (MIC) from the ESB is 700kVA, or 1063A at 380V. The Main Plant is supplied by a medium voltage (MV) supply. The St.Colm’s, QC & the SSB Buildings are supplied by a low voltage (LV) supply. The location of these supplies are provided in Application Form Drawing 1 , Application Form Drawing 2 and Application Form Drawing 3 in Attachment A.1 .
In terms of energy usage in Elanco used 4,284,927kW of electricity in 2011. Greater than 90% of the site’s electricity consumption is utilized in the Main Plant where manufacturing takes place.
It is noted that electrical consumption by the facility has increased by approximately 8.9% in 2011 when compared to the 2010 reported figure. It is considered that this increase is indicative of both the increased production activity at the site and also the start of the commissioning and qualification stage of the Stellamune Extension.
Fuel 297,495 litres of light fuel oil was consumed by the facility in 2011. This represents a slight decrease in the quantity of fuel oil consumed in 2011 (-3%) when compared to the 2010 figure. 2,723 litres of kerosene was consumed by the facility in 2011, a 4.7% decrease in consumption when compared to the 2010 figure. For inspection purposes only. Consent of copyright owner required for any other use.
This consumption is related to base-load maintenance for the generation of steam and hot water. Additionally, an extended cold snap in 2010 affected the utility demand at the facility.
Boiler house operations burn light fuel oil and use mains water to generate stream for domestic heating, sterilising and HVAC systems operation.
In accordance with the site’s maintenance systems, low sulphur fuels, periodic preventative maintenance and best boiler-house practice are implemented to minimise any smoke effluent and to maximise efficiency of combustion of all boilers at the facility.
A back-up electricity generation system located at the Main Plant is also similarly maintained.
Energy Efficiency - Buildings The facility at Finisklin has been in operation since 1991 and has expanded operations on site on a phased basis to include SSB building, quality control building and the warehouse, labelling/packaging property (St.Colms). As additional space has been required modifications have been made to the existing Main Plant and QC buildings and additional buildings have been rented when required (St.Colms and the SSB Building).
Page 66 of 235
EPA Export 29-05-2012:04:39:42
IPPC Application Form V2/12
A master planning exercise was conducted to assess the insertion of the Stellamune Extension at the Main Plant. The process of master planning consisted of the following phases: Site a potential maximisation phase; Plant synergy layout phase; and Design optimisation phase.
Each phase was intensively reviewed and the objective of the master plan was to decide how to efficiently integrate the Stellamune Extension into the existing manufacturing site.
The master planning exercise was conducted to assess the insertion of a number of options for the proposed extension on the existing Elanco Main Plant. Thus all main master planning decisions relating to the location and layout of the proposed extension have been evaluated in the context of determining the most sustainable option as well as a number of broader technical criteria which are reported on in the Stellamune Extension Environmental Impact Statement.
The Stellamune extension is designed as a compact ‘stand-alone’ facility. However, the extension is linked to the existing manufacturing area so as to facilitate both separation and containment whilst also maintaining access to some existing services within the Main Plant.
This link to the Main Plant allows for areas such as gowning rooms, warehousing, dispensary, media preparation, wash and sterilization areas and some utilities to serve both the existing manufacturing facilities and the Stellamune extension .
It was considered that this option was the most efficient option for development where the shared facilities would reduce the potential energy demand required compared to the Stellamune extension being constructed as separate building from the existing Main Plant.
The Stellamune extension equipment and suite have been designed and commissioned to meet or exceed the requirements of For Containment inspection purposes only. Level 2 (CL2) as defined in Draft Consent of copyright owner required for any other use. Safety, Health and Welfare at Work (Biological Agents) Regulations 2010 (Ref. 4.1) and the current EC Directive (Ref.4.2) and SI No. 248/1998 (Ref. 4.3). Any other micro organism species that requires this degree of separation and containment can also be used in the suite in the future. The extension has been constructed in accordance with the Building Regulations 1997-2011 and not been oversized, but has been designed to the appropriate size for Elanco’s requirements.
Energy efficiency measures utilised in the Stellamune Extension include the use of variable speed drives in the HVAC system, 100% leak testing of HVAC ducting, the use of efficient lighting throughout the extension, the use of Passive Infrared Detectors in corridors. All cladding and insulation will have low U-Values (thermal transmittance) in compliance with the Part L of the Building Regulations and there will be extensive lagging of internal equipment and pipework.
Elanco have conducted an energy survey of the site and this has been integrated into the site Environmental Management Programme.
Municipal Water Usage In 2011 the facility used 27,292m3 of municipal water. The main activity which consumes municipal water at the facility is the cooling water system at the Main Plant, which utilizes approximately 75% of the water supply. Plant cooling is needed for equipment
Page 67 of 235
EPA Export 29-05-2012:04:39:42
IPPC Application Form V2/12 such as the HVAC, autoclaves, freeze-dryer and Bioreactors. This utilises municipal water as economically as is practicable and is discharged to sewer via the controlled conduits.
The day-to-day manufacturing processes utilize nearly the remaining 25% of the municipal water consumed on site.
Water conservation initiatives for the site are outlined and submitted to the EPA as part of the site’s Environmental Management Plan 2010 and EMP 2011-2015.
Elanco Environmental Management Programme (EMP) Through the EMP Elanco are committed to a policy of responsible energy management.
In 2010 and 2011 Elanco instigated and monitored a series of environmental initiatives. Copies of the EMP 2010 and EMP 2011-2015 have been included in Attachment N o G.2. These initiatives have included projects to reduce energy usage, electricity consumption, carbon emissions and waste volumes.
Future Energy Usage Elanco will continue to monitor fuel, water and electricity usage at the facility and report the results of this monitoring in the AER.
The Stellamune Extension will share services with the existing Main Plant building. During the commissioning & qualification phase of Stellamune (Q4 2011- Q3 2012) it is expected that there will be additional short-term (peak) fluctuation demand on resources on top of normal production consumption. Additionally, there is an expectation of an overall increase in resource consumption over the short-to-medium term especially when the new Stellamune processes at the Main Plant come on-line, fully in 2014.
Overall, it is not anticipated that the Stellamune Extension will result in a significant increase in fuel, water and electricity consumption at the facility.
Elanco Sligo want to assure the Agency that as the site navigates through this transition period we are committed to using resources in an efficient and environmentally friendly manner based on continuous improvement, which is consistent with the site’s environmental policy. For inspection purposes only. Consent of copyright owner required for any other use. It is confirmed that the Stellamune Extension has been considered in setting the EMP targets for 2011-2015.
Page 68 of 235
EPA Export 29-05-2012:04:39:42
IPPC Application Form V2/12
SECTION H: MATERIALS HANDLING
H.1 Raw Materials, Intermediates and Product Handling
A comprehensive list with full details of the raw and ancillary materials, substances, preparations, fuels and energy utilised at the facility and including future materials from the Stellamune extension are provided in Table G.1(i) and Table G.1(ii).
Raw Materials The systems and procedures outlined in the sections below with regard to raw materials handling, storage, unloading etc are currently implemented on site and will directly apply to the Stellamune extension once operational.
Transport of Raw Materials All materials for the facility are initially received at the warehouse (St.Colms building). From here they are logged and stored in the appropriate manner.
All materials used at the Elanco facility require to be stored at different locations (i.e. St. Colms, Main Plant and QC Building etc.) depending on the nature of the material. Following initial receipt, transport from St. Colms to the other areas of the site and primarily the Main Plant, is undertaken by the company owned van.
All materials transferred to the Main Plant are received to the Main Plant Warehouse.
Materials are then either stored at the Main Plant warehouse or they are distributed for storage to the appropriate areas of the Main Plant and Stellamune Extension.
The existing Main Plant is, and the Stellamune Extension will be, appropriately equipped with a series of freezers/freezer rooms, fridges/cold rooms and storage cupboards.
Additionally, it is noted that all buildings at the Elanco facility are secured by swipe access. No member of the public or visitor can access the buildings without being accompanied by a member of the Elanco staff. For inspection purposes only. Consent of copyright owner required for any other use. Raw Materials Management Management including storage and segregation of materials on site is managed in accordance with the following requirements:
All materials are segregated according to their individual properties and individual storage requirements; All materials are clearly labelled with details to include name, hazard identification and expiry date; All branded packaging materials are stored in locked cages in the warehouse; All flammable chemicals remain segregated and separately stored in a dedicated locked chemical cabinet at the rear of the St.Colms building; and All other non flammable chemicals are stored in locked chemical cabinets with sufficient spill/drip containment capability. Materials requiring storage at lower temperatures are held in the cold room facilities.
Page 69 of 235
EPA Export 29-05-2012:04:39:42
IPPC Application Form V2/12
Intermediates Intermediates which are produced during the manufacturing process are stored at both the Main Plant and QC building.
All intermediate products (which are identified in Table G.1 (i)) in use at the facility are stored in dedicated containers at both buildings or within the manufacturing vessels during the actual manufacturing process within the Main Plant. If the intermediates are not being stored within the manufacturing vessels and require temporary storage, the storage containers are stored on spill trays which are appropriately sized to retain the contents in the event of a spill.
All substances (powders and liquids) are stored the designated cabinets when they are not in use. Additionally, all containers used to contain chemical substances are clearly labelled with the Chemical Name, Hazard and Expiry Date.
Chemical substances are segregated and stored in the areas outlined below and these areas are identified in Application Form Drawing 8 , Application Form Drawing 9 and Application Form Drawing 10 included in Attachment A.1.
The warehouse areas of St.Colm’s, QC building, the Main Plant and the Stellamune Extension; The equipment transfer room in the Main Plant; The media weigh room of the production area of the Main Plant; The Chemical and Environmental Laboratory in Quality Control Building; The Media preparation room in the Main Plant; The external chemical waste stores in QC building and the Main Plant; and The storage cabinets located in the Main Plant and outside the warehouse in St.Colm’s.
It is noted that small amounts of chemical substances are stored in all of the facility areas e.g. items such as cleaning agents etc.
Handling and Control of Carcinogens For inspectionand Suspected purposes only. Carcinogens & Mutagens In order to comply Consent with of copyright regulatory owner required for any requirements,other use. the EHS
Department carry out an assessment of the risks associated with the use of each carcinogen or mutagen in the workplace and take steps to control such risks by eliminating or minimising exposure.
Details of all carcinogen and mutagen type substances are provided in Table G.1(i) and Table G.1(ii).
All containers, packaging and installation containing carcinogens or mutagens are labelled clearly and legibly and have the appropriate risk phrase and hazard symbol attached.
Containers of carcinogens and mutagens are opened only in a Microbiological Safety Cabinets/fume hoods/down flow bench and protective clothing as stated in Material Safety Data Sheet (MSDS) is worn when using carcinogens and mutagens.
As identified in Elanco’s Storage, Use and Control of Dangerous Substances and Solvents SOP (SOP-OO7-01), a list of employees exposed to any carcinogens or mutagens while at work is retained on file by the EHS Officer.
The EHS Officer is responsible for providing information and training to all relevant employees on the nature of the hazard and the risks associated with the use of
Page 70 of 235
EPA Export 29-05-2012:04:39:42
IPPC Application Form V2/12 carcinogens or mutagens in the workplace. The training includes information on the wearing and use of protective equipment, hygiene requirements and potential risks to health.
As part of the Elanco occupational health policy, health surveillance is provided for all those employees that may be exposed to known carcinogens.
Final Products All final sealed and packaged products are stored at the St.Colms warehouse prior to export from the facility.
The key areas of material storage have been identified on Application Form Drawing 8, Application Form Drawing 9 and Application Form Drawing 10 in Attachment A.1.
Fuels Apart from light fuel oil and kerosene, no large volumes of volatile substances are stored at the facility. No solvents are used in the manufacturing process and no solids are stored in the open.
With regard to loading and unloading activities, Elanco have in place an SOP relating to The Safe Loading & Unloading of Fuel Oil (SOP 01-032) which outlines the requirements for the safe delivery of fuel oil to the facility and its subsequent transfer and storage in the designated fuel containers. All fuel loading and unloading activities are carried out in accordance with this SOP.
All fuel deliveries and ‘dipping’ of tanks must take place during normal working hours, i.e., Monday-Friday between 08:30-17:00 each day, except Friday (08:30-16:00).
Consignments of fuel oil cannot be unloaded until the EHS Officer or designee has been notified.
A Fuel Oil Unloading Inspection Checklist is completed for each fuel oil delivery location and forwarded to the EHS Officer or designee.
For inspection purposes only. The designated supervisor of theConsent fuel ofdelivery copyright owner ensu requiredres forthat any other the use. spill containment valve is closed while the truck is parked on the containment pad.
Upon completion of delivery for each fuel oil consignment, the driver and competent person must verify and agree the volume transferred into the fuel oil tank(s).
Upon completion of delivery for each fuel oil consignment the driver and competent person must each sign the delivery docket or invoice.
The delivery of fuel oil where the truck parks outside of the Elanco premises is prohibited. An exception may be made to allow an emergency delivery of fuel oil. However, prior authorisation must be obtained from a Senior Manager and/or the EHS Officer and a work permit must be issued.
Any spillages during fuel loading or unloading must be documented immediately and documentation forwarded to the EHS Officer immediately.
Page 71 of 235
EPA Export 29-05-2012:04:39:42
IPPC Application Form V2/12
Bunded Structures All fuels are stored within designated bunded/contained areas which are subject to weekly inspection by Elanco personnel and also periodic (every three years) integrity tests. There are also several bunded chemical storage areas at the facility. The table below outlines the bunds/contained areas on site and their capacity.
ID Description Capacity Main Plant MP-02 Sprinkler Pump Fuel Tank Bund 2,053 lts. MP-03 Double Skinned Oil Storage Tank 18,000 lts. MP-04 Double Skinned Oil Storage Tank 18,000 lts MP-05 Bunded Delivery Apron 1,947 lts. MP-06 Chemical Store 1,200 lts. MP-07 Chemical Store 1,098 lts. MP-08 Chemical Store 1,098 lts. MP-09 LV Trafo Bund 898 lts. MP-10 Double Skinned Oil Tank 200 lts. MP-10 Yellow Plastic Bunds 315 lts. MP-11 Yellow Plastic Bunds 315 lts. MP-12 Paint Stores Capacity 260 lts. MP-13 Paint Stores Capacity 260 lts. Quality Control Laboratory QC-01 Chemical Store 1,098 lts. QC-02 Bunded Delivery Apron 1,758 lts. QC-03 Double Skinned Oil Tank 2,600 lts. Support Services Building SSB-01 Double Skinned Oil Tank 2,700 lts. St. Colms Building SC-01 Double Skinned Oil Tank 5,400 lts. SC-02 Polystore 220 lts. SC-03 Chemstore 300 lts.
Copies of site drawings detailing the location of these bunds /contained storage areas are included in Attachment H.1 . For inspection purposes only. Consent of copyright owner required for any other use. Bund Maintenance and Servicing A member of the Engineering Department carries out a weekly inspection of the fuel tanks, pipework and stormwater build up in bunded areas. The findings of the weekly inspection are recorded and forwarded to the EHS Officer.
The Safe Loading and Unloading of Fuel Oil SOP outlines the actions which should be taken to drain stormwater from affected bund areas.
Should water within the bund become contaminated with fuel, an approved waste contractor will be brought on-site to remove the contaminated wastewater, which will be transported off-site for appropriate treatment / disposal. Fuel contamination is determined by the use of paper strip testing of water in the bund.
Designated personnel or an approved contractor clean out the bunds on an annual basis and records are maintained by the EHS Department.
Each bund is inspected and certified every three years by an external approved contractor. Records of such inspections are kept on file by the EHS Officer or designee.
Page 72 of 235
EPA Export 29-05-2012:04:39:43
IPPC Application Form V2/12
Copies of recent bund inspections and certifications are maintained at the facility and are available upon request. A summary of recent bund testing, along with site drawings indicating the bund locations have been included in Attachment H.1.
Firewater Retention / Management In the event of a fire, the resulting firewater will be collected from the Stellamune manufacturing suite and decontaminated chemically before being neutralised and disposed off site following liaison with the EPA and relevant Local Authorities. Firewater from Containment Level Two designated areas is directed to a designated firewater tank located in the vicinity of the Stellamune extension at the Main Plant.
The calculated required tank water volume, based on firewater run-off rates and the room areas is 115m 3.
No fire water retention management issues have occurred to date at the Elanco facility. However, a Fire Water Risk Management Study has been commissioned by Elanco in accordance with EPA Draft Guidance Note to Industry on the Requirements for Fire- Water Retention Facilities to risk assess and identify any potential requirements with regard to firewater retention facilities/management. The results of this study are expected to be available in Summer 2012.
Services The site is served with potable water by a connection to the existing Sligo Town Water Supply (Sligo County Council water main).
The site discharges effluent to the existing Sligo sewerage system via two discharge points, one at the Main Plant building and one at the Quality Control Building.
The sites electrical supply is currently served by a connection to the existing ESB 10kV electricity supply system.
H.2 Describe the arrangements for the recovery or disposal of solid and liquid wastes accepted into or generated by the installation/facility.
Tables H.1(i) and H.1(ii) details all of the waste materials currently generated on the For inspection purposes only. site and reflects the waste streamsConsent of copyright which owner will required be for g anyenerated other use. from the Stellamune extension including, name, EWC Code, quantity, nature and the on-site and off-site recovery / disposal as well as the source(s).
The systems and procedures outlined in the sections below with regard to waste control and management are currently implemented on site and will directly apply to the Stellamune extension once operational.
Waste Management Elanco has a well developed waste management, minimisation and auditing strategy.
Waste arises through the different manufacturing and packaging processes at the facility. Waste management at Elanco is based on the proximity principle and the waste hierarchy.
Waste generation is prevented where possible and minimized when produced. All waste produced is recovered, recycled or disposed of in an environmentally responsible manner by licensed waste contractors.
All waste handling contractors and waste disposal facilities used by Elanco are fully permitted (by Local Authorities) and/or licensed (by the EPA) as relevant.
Page 73 of 235
EPA Export 29-05-2012:04:39:43
IPPC Application Form V2/12
In addition, all transportation of waste materials from the site is undertaken by contractors who have valid Waste Collection Permits (WCP) in place.
Elanco maintains a register of all waste contractors. The following is a list of the primary and secondary waste contractors currently utilized by Elanco:
AGR MBH, Herten, Germany AVG, Hamburg Germany Bailey Waste, Dublin (Greenstar) Ballynagran, Residual Landfill, Co. Wicklow Connaught Waste Recycling, Galway Emerald Salvage & Recycling Ltd Galway Metal Recycling Greenstar, Sligo Horizon Environmental Indaver Ireland Indaver NV, Antwerp, Belgium Irish Lamp Recycling Ltd Rehab Recycling, Tallaght, Ireland Rilta Environmental Ltd, Rathcoole, Co. Dublin WERS Waste, Tuam Co.Galway SRCL – Eco Safe Systems Ltd
Copies of the Waste Permits, Waste Licences and Waste Collection Permits for the waste contractors used by Elanco have been included in Attachment H.2 . Also included are an example of the certificate of destruction of waste provided by the waste contractors and a completed Transfrontier Shipment of Waste Form (TFS). Copies of the certificates of destruction and completed TFS Forms are maintained on site and are available for inspection upon request.
The EPA are given prior notice of any new waste contractors Elanco intend to use. The EHS Officer keeps on file a list of the contractors that are approved for use. For inspection purposes only. Consent of copyright owner required for any other use. Non-Hazardous Waste Control Management Elanco has developed a Non-Hazardous Waste Control Management Standard Operating Procedure (SOP-01-009). This details the responsibilities and procedures for the disposal of non-hazardous waste.
Each Department is responsible for the correct segregation and bagging of waste arising from their department.
Non-hazardous waste at the Elanco facility is divided into the following categories:
General Waste; Compost; Mixed Dry Recyclables ; Cardboard Packaging; Aluminium Drinks Cans; Non-Hazardous Production Waste (i.e. used tyvek gowns); Glass Waste; Sharps Waste; Waste inkjet and toner cartridges; Waste office paper; and
Page 74 of 235
EPA Export 29-05-2012:04:39:43
IPPC Application Form V2/12
Miscellaneous non-hazardous waste (i.e. metals)
All contractors that handle waste from the Elanco facility have a valid Waste Collection Permit and they may also be required to have a Waste Permit (Local Authority) or Waste Management licence (EPA).
The St.Colm’s, QC & the SSB buildings have waste receptacles located at the back of the buildings for the collection of non-hazardous waste which is then collected by the approved and licensed waste contractor.
The Main Plant has a compactor and occasionally extra receptacles (bins or skips).
General Waste / Compost + Mixed Dry Recyclables Compost (food/organic) waste is segregated and placed in designated compost bins.
Dry mixed recyclables arising in the canteens and administration areas are placed in the designated recyclables (green) bins.
Other waste streams (general waste) which cannot be recycled and arising from the canteens and administration areas of each building is collected in black refuse bags, tied and placed in the designated waste receptacle.
All waste is stored in the waste receptacle of the building prior to collection by the approved and licensed waste contractor.
When the contractor collects the waste, the driver for the waste contractor, must provide a signed collection docket and where relevant indicate the registration number of the vehicle collecting the waste, the date and time the waste was collected and the relevant EWC code.
Bio-hazardous Solid Waste Control Management Elanco has developed a Disposal of Bio-hazardous Waste Standard Operating Procedure at Elanco Sligo (SOP 01-008). This details the responsibilities and procedures for the disposal of bio-hazardous waste. Bio-hazardous waste is defined as potentially infectious and includes waste stream such as HEPA For inspection filters, purposes broken only. glass and sharps waste Consent of copyright owner required for any other use. Bio-hazardous waste streams are produced at the Main Plant and QC Building only.
Key items in the Disposal of Bio-hazardous Waste SOP include the following:
IPA waste. HEPA Filters. Sharps. Broken Glass. Consumable waste. Waste antigen and blend material.
All waste items generated in a “live” room are classed as potentially infectious waste. Therefore they must be sterilised before disposal in the autoclaves.
The consumable wastes, such as paper which are produced in “live” rooms at the Main Plant are sent off site to be sterilised by an approved waste contractor.
All sharps and broken glass located in the Live Room must be placed in the approved sharp’s boxes provided to prevent possible tearing of surrounding plastic bags and ‘UN’ approved yellow biohazard bags.
Page 75 of 235
EPA Export 29-05-2012:04:39:43
IPPC Application Form V2/12
All ’UN’ yellow bag waste from a live room is given a ‘live’ label available in the production area, which includes the following information; Date, Process lot number, Room number and signature.
Full bio-hazardous waste containers are secured in dedicated compounds in each of the Main Plant and QC buildings. The door leading into each compound is locked and therefore access is restricted.
The approved bio-hazardous waste contractor call on site periodically to collect full bins and leave replacement bins. The waste is disposed of to a suitably licenced facility and copies of the certificates of destruction are maintained by the EHS department.
Bio-hazardous Waste - Disposal of live and/or contaminated cells, seeds and MLV antigen stocks. Sometimes cells, seeds or MLV antigen stocks need to be disposed of because of unintentional contamination. These need to be disposed of as live waste through the following procedure:
If applicable the appropriate Material Disposal Authority (MDA) must be approved and forwarded to the Relevant Department before this material can be processed for disposal purposed. The EHS Officer or designee is consulted prior to disposal. Unfinished biological material is placed in ‘UN’ approved bags which are heat sealed, labelled and disposed of as described per bio-hazardous waste. Details of the waste are logged into the bio hazardous waste logbook.
Bio-hazardous Waste - Filled/Finished Product Disposal This includes all reject or recalled product i.e., those presented as MLV freeze dried cake (vial), or inactivated blend (bottle/syringe) and is disposed of as follows. Finished product can only be disposed of if a deviation report has been issued. An MDA is then issued from the QC department and forwarded to the Materials Department. For inspection purposes only. Consent of copyright owner required for any other use. Only material that has a red reject label can be disposed of. Disposal of this material must take place in a controlled area to eliminate the risk of it re-entering the main production streams. This usually takes place in a designated area in St.Colm’s, in consultation with the Logistics Manager or designee. A product that has not yet been packaged is stored in blue totes. As the product is removed, all labels on the inside and outside of the totes are removed & defaced. Additionally all packaging, i.e., cartons, labels and inserts must be defaced/destroyed for product that is packed and/or palletised. All vials, bottles and syringes with product must be disposed in ‘UN’ approved 60 litre bins. Each bin, when full, is sealed and labelled with ‘UN 3291’ on one side and an infectious substance label on the opposite side. The approved Bio-hazardous waste vendor provides all bins, lids and appropriate labels. Each bin is filled only to 50% of its capacity and the bin lid is firmly attached. In addition prior to transport off-site, each pallet is strapped and visually checked to ensure the bins are secure thereby minimising
Page 76 of 235
EPA Export 29-05-2012:04:39:43
IPPC Application Form V2/12
the risk of damage during the duration of transport to the designated licensed waste facility.
When sufficient numbers of these bins are generated, they are palletised, shrink- wrapped, labelled and stored in the locked reject product container located externally at the St.Colms building.
The EHS Officer arranges collection by the approved bio-hazardous waste contractor, for final disposal. Details of the route of disposal are noted on the MDA along with the time and date of disposal.
The EHS Officer records and files the details of all MDA’s shipped from the Elanco facility including all subsequent waste records
Solid Waste Management – Sludge Management (Sligo WWTP) Sections E and I refer to the management of wastewater emissions from the site with regard to the presence of levels of mercury from Thimerosal which is a vaccine preservative used on site.
Having implemented the isolation and capture at source process on site, the rinsings from the Cleaning In Place procedures on site will results in only 22.7gm of mercury being discharged from the facility to the combined sewer and Sligo WWTP each year. This annual discharge from the facility is the equivalent of 4 human tooth fillings being discharged to the sewer each year.
From the sewer, the wastewaters are discharged to the Sligo WWTP prior to discharge to the final receiving waters of the Garavogue River Estuary.
With specific regard to solid waste and the management of sludge generated at the WWTP, modelling and mass balance assessments have determined that the volume of mercury in sludge attributable to the Elanco facility is 2% of the 0.5kg which is currently discharging to the sludge from other municipal sources. The volume of mercury in the sludge relating to the Elanco facility is the equivalent of 4 human tooth fillings per annum. For inspection purposes only. It is not considered that theseConsent levelsof copyright will owner required have for an anyy other impact use. on current sludge requirements for the WWTP facility.
The specific worst case calculations relating to the levels of mercury in sludge from the Sligo WWTP may be calculated as follows.
“According to the “2010 ANNUAL ENVIRONMENTAL REPORT FOR SLIGO WASTEWATER TREATMENT WORKS” the Total Tonnage of Bio-Cake Disposed off- site in 2010 by the Sligo County Council wastewater treatment was 435.09 Tonnes (see APPENDIX 2 , AER Returns Workbook)(3).
If we assumed that 95% of all mercury going into the plant per year was absorbed to sludge disposed off-site, the estimated concentration of mercury in this sludge from our proposed discharge would be 1.04 mg/kg [((22.7 grams per annum x 1,000 milligrams per gram)/0.05)/435,090 kilograms of sludge exported per year)].
The relevant regulations are the SI 267 of 2001 Use of Sewage Sludge in Agriculture amended regulations. These express the heavy metal limits as the amount permitted per hectare /annum over a 10 year period.
Page 77 of 235
EPA Export 29-05-2012:04:39:43
IPPC Application Form V2/12
To generate the worst case we have assumed the AER reported average of 435 tonnes /annum (which exceeds the theoretical biological sludge generated from a full 28,000pe loaded plant at a sludge generation rate of 0.4 kg dry solids per kg BOD removed, which yields approximately 245 tonnes dry matter /annum).
The maximum classically permitted dry solids loading per hectare is 2.0 tonnnes/annum so this on a worst case basis is 218 hectares as the minimum land area needed per annum for Sligo.
At 0.1 kg Hg/hect /annum that means that the maximum tolerable Hg content per annum would be 21.8 kg Hg in the 435tonnes dry weight.
Therefore, Elanco at 22.7 grams /annum at 100% transference or adsorption in the sludge at 100% production capacity would only represent approximately 1/ 1000th of the permitted maximum value as an absolute worst case.”
Liquid Waste Management Process wastewater from the Main Plant is fed into a holding tank before entering the main sewer drain for the Industrial Estate. The pH of the wastewater is continuously monitored. If the pH limit value of the IPPC licence is exceeded, a signal will be relayed to the discharge shut-off valve from the pH system to prevent any further release of wastewater.
At the QC Building the pH of the wastewater is monitored. If the pH level is outside the limit value of the IPPC licence (5-10 pH units), the wastewater is directed to the hazardous waste chemical stores, where it is temporarily stored before disposal via a licensed contractor.
Wastewater from the Main Plant is tested on a weekly, monthly, quarterly and annual basis for a range of parameters and reported in the facility’s QER and AER. Elanco is currently regulated under IPPC Licence No.0090-01. The licence provides emissions limits for wastewater leaving the facility.
Sanitary wastewater is collected in a separate collection system on site and then combined with the process water off site and conveyed directly to the Sligo Waste Water For inspection purposes only. Treatment Plant. Consent of copyright owner required for any other use.
Copies of the Disposal of Bio-hazardous Waste at Elanco Sligo SOP (SOP-01-008) and the Non-Hazardous Waste Control Management SOP (SOP-01-009) and the associated waste records are maintained at the site and are available for inspection by the Agency upon request.
Disposal of Waste (General) Only waste disposal contractors that have been approved for use by a Corporate Parent Company and the Environmental Protection Agency can be used for the disposal of bio- hazardous waste from Elanco Sligo.
With regard to chemical and bio-hazardous waste materials, these waste streams are disposed of in accordance with the Waste Management Act 1996, amended by Waste Management (Amendment) Act 2001, Waste Management (Hazardous Waste) Regulations 1998 as amended, Waste Management (Movement of Hazardous Waste) Regulations 1998. Additionally, all waste disposal contractors must comply with Carriage of Dangerous Goods by Road (ADR) regulations, which govern the transport of dangerous and hazardous materials by road or rail within the EU.
Page 78 of 235
EPA Export 29-05-2012:04:39:43
IPPC Application Form V2/12
Management of Waste Records At the end of each month the Accounts Department sends copies of each collection docket to the EHS Officer along with copies of all invoices for waste disposal.
It is the responsibility of the EHS Officer or designee to keep an up to date spreadsheet of all waste shipments from our facilities for all waste types, including non-hazardous and liquid waste in secure containers.
The net weight of each shipment will be recorded on this spreadsheet, when they become available from the waste contractors.
Waste disposal by on-site landfilling
No waste disposal by on-site landfilling takes place at the Elanco site.
For inspection purposes only. Consent of copyright owner required for any other use.
Page 79 of 235
EPA Export 29-05-2012:04:39:43
IPPC Application Form V2/12
SECTION I: EXISTING ENVIRONMENT & IMPACT OF THE ACTIVITY
Describe the conditions of the site of the installation. See individual sections below.
Provide an assessment of the effects of any emissions on the environment, including on an environmental medium other than that into which the emissions are made. See individual sections below.
Describe, where appropriate, measures for minimising pollution over long distances or in the territory of other states. See individual sections below.
I.1.Assessment of atmospheric emissions
Describe the existing environment in terms of air quality with particular reference to ambient air quality standards and provide a statement whether or not emissions of main polluting substances (as defined in the Schedule of S.I. 394 of 2004) to the atmosphere are likely to impair the environment.
With regard to S.I. 394 Environmental Protection Agency (Licensing) Amendment Regulations 2004, it is not considered that the emissions to atmosphere from the facility will impair the environment.
The main sources of air pollution in the vicinity of the facility are vehicular emissions from traffic accessing the industrial estate. Given the absence of “heavy” industrial operations within the industrial estate, the sources of air pollutants are relatively limited.
Background air quality in the area is considered to be very good in the context of the European Air Quality Standards (AQS). An air quality assessment was undertaken by the EPA in Sligo in 2003. The EPA air monitoring station was located, from January – October 2003, in the carpark of the Sligo General Hospital, which is approximately 2.0km from the Elanco facility.
No limit values for the following parameters For inspection purposes were only. exceeded during the monitoring Consent of copyright owner required for any other use. period:
Carbon Monoxide; Sulphur Dioxide; Nitrogen Dioxide; Oxides of Nitrogen; Particulate Matter; Benzene; and Lead
A survey of nitrogen dioxide (NO 2) concentrations was carried out in the vicinity of the Elanco facility for a period of 1 month in 2010, using diffusion tubes, in a range of background and roadside locations. The measurements obtained are indicative and comparable to the AQS annual mean concentration. The indicative diffusion tube results are all well below 40 µg/m 3, the Air Quality Standards annual mean value for nitrogen dioxide. The highest average value reported for this monitoring period was 9.50 µg/m 3 at the monitoring location at St Colms, in the vicinity of the main road accessing the industrial estate.
Page 80 of 235
EPA Export 29-05-2012:04:39:43
IPPC Application Form V2/12
Given the limited sources of air pollutants and based on the results of the environmental monitoring assessment in 2003 and 2010, it is considered that the AQS would be met in the vicinity of the Elanco facility.
In accordance with the provisions of the current IPPC licence, the existing facility is required to monitor air emissions from the existing production facility from 3 emission points.
Monthly monitoring to verify the absence of biological agents in the air emissions from the Main Plant is undertaken. The 2008 - 2011 Annual Environmental Reports (AERs) for the Elanco facility, which were submitted to the EPA, indicate that no biological agents were detected in the air emissions.
Additionally, air emissions are monitored on a quarterly basis for TA Luft Class III Organics. A summary of the quantities of TA Luft Class III Organics emitted in 2008, 2009, 2010 and 2011 is outlined in the table below:
Table I.1 - TA Luft Class III Organics Mass Emissions 2008, 2009, 2010 and 2011 Parameter – Mass Mass Mass Mass IPPC TA Luft Class III Emissions Emissions Emissions Emissions Licensed Organics (Kg) - (Kg) – (Kg) - (Kg) - Emissions 2008 2009 2010 2011 (Kg) Emission Point A 14 2 107 126 5,548 Emission Point B 328 252 1,269 1,827 3,650 Emission Point C 13 7 185 598 8,322
There was a significant increase in the TA Luft Class III Organics emitted in 2010 and 2011, when compared to 2009. The increase was correlated to the volumetric airflow rates from the emission points. This increased airflow rate was generated from the bi- annual validation/qualification of HVAC systems. The emissions were still within the licenced limits.
Table I.1 identifies that the volumes of mass emissions from the three emissions points is For inspection purposes only. significantly below the IPPC licensedConsent emission of copyright owner limi requiredt. for any other use.
No air dispersion modelling has been undertaken at the facility as none was required for the EIS.
Give summary details and an assessment of the impacts of any existing or proposed emissions on the environment, including environmental media other than those into which the emissions are to be made.
Airborne particle less than 10 microns in aerodynamic diameter (PM 10 ) and NO 2 are the two most significant air pollutants arising from traffic emissions. During the opening year 2014, the Stellamune extension is likely to give rise to a maximum of 10 - 15 additional staff vehicles per weekday and a limited number of additional deliveries.
In terms of air quality, this would result in an insignificant increase in air pollutants in the immediate vicinity of the road into the Main Plant. Furthermore, given the current good air quality and the minor increase in additional traffic accessing the Main Plant, Air Quality is expected to remain well within the standards.
As there are no odour releasing issues with any of the materials used in the process and the Main Plant is a closed system it is expected that there will be a negligible release of odour to the environment.
Page 81 of 235
EPA Export 29-05-2012:04:39:43
IPPC Application Form V2/12
It is noted that TA Luft Class III Organics list has been reclassified and that the EPA have indicated Isopropanol emissions should be now be classified under the Total Organic Carbon category.
The Stellamune extension will result in the addition of minor emissions of Isopropanol to the atmosphere from the Main Plant. However, when reviewed against the mass emission threshold for the Total Organic Carbon category, they have been classified as minor emission points in Section E of the application and as such are not considered to have a significant impact on the environment.
Attachment N o I.1 should also contain full details of any dispersion modelling of atmospheric emissions from the activity, where required. When carrying out dispersion modelling, regard should be had to the "Guidelines for the Preparation of Dispersion Modelling Assessments for Compliance with Regulatory Requirements – an Update to Royal Meteorological Society Guidance " or similar guidelines from a recognised authority.
AERs for 2008-2011 are presented in Attachment N o C.1.
The EIS for the Stellamune extension is presented in Attachment N oB.5.
Dispersion Modelling was not undertaken at the facility due to the limited air emissions and the low concentrations that were monitored in the local environment in accordance with the current IPPC Licence.
I.2. Assessment of Impact on Receiving Surface Water
Describe the existing environment in terms of water quality with particular reference to environmental quality standards or other legislative standards. Table I.2(i) should be completed.
There are no surface water bodies on or in the vicinity of the site, and there is no direct release from the facility to surface water bodies. On this basis, Table I.2(i) has not been completed. For inspection purposes only. Consent of copyright owner required for any other use. The surface water drainage network on site drains surface water run off from hardstanding and roof areas to combine with the process water and foul water systems within the site boundaries.
The flow is then directed off-site into the Local Authority combined sewer before discharging to Sligo’s WWTP. The WWTP provides tertiary treatment and discharges to the Garovogue River Estuary which is designated as Cummeen Strand/Drumcliff Bay (Sligo Bay) proposed Natural Heritage Area (pNHA 000627), Cummeen Strand/Drumcliff Bay (Sligo Bay) Special Area of Conservation (SAC 000627) Cummeen Strand Special Protected Area (SPA 004035).
Give summary details and an assessment of the impacts of any existing or proposed emissions on the environment, including environmental media other than those into which the emissions are to be made.
Emissions of the main pollution substances defined in S.I. 394 of 2004 are not likely to impair the environment.
All surface water, process water and foul water from the site are discharged to foul sewer and subsequently treated by the Sligo WWTP.
Page 82 of 235
EPA Export 29-05-2012:04:39:43
IPPC Application Form V2/12
Currently, emissions from the site to the Local Authority sewer have been in accordance with the IPPC Licence conditions and are reported in the sites AER’s which are submitted to the Agency. All emissions to the foul sewer from the site will continue to be monitored in accordance with IPPC licence conditions.
As identified in previous sections, Thimerosal is an organomercurial salt chemical which is used at the facility as a vaccine preservative. Mercury is included as a List I dangerous substance under the Dangerous Substances Directive (2006/11/EC).
With respect to this substance, a detailed assessment was undertaken by Elanco to assess the potential impact of emissions containing mercury on the final receiving water environment. This included Irish Hydrodata modelling ( Attachment I.2) and the associated mass balances take all inputs into consideration on a worst case basis to demonstrate the impact on the receiving environment.
Consideration in Section E.3 has been given to the requirements under the relevant Dangerous Substances Regulations.
Directive 2008/105/EC, of 16th December 2008, on Environmental Quality Standards (EQS) in the field of Water Policy sets a mercury environmental quality standard of 0.05microg/l, as an annual average and 0.07microg/l as a maximum allowable concentration (MAC). This would apply to the impact of the combined emissions from the agglomeration of Sligo WWTP plus natural background levels in the external environment.
It is noted that no primary materials containing mercury are discharged from the facility. However, the Clean In Place (CIP) process within the facility (existing and Stellamune) results in very low concentrations of mercury being discharged in the process wastewaters from the site to the sewer.
A capture at source process of the CIP wastewaters is implemented on site and it has been estimated that this process reduces the levels of mercury in the CIP wastewater by 99.87% prior to discharge to the Local Authority combined sewer and Sligo Wastewater Treatment Plant (WWTP).
This process is implemented by capturing the CIP wastewater generated during the first For inspection purposes only. rinse of the CIP process into suitableConsent containersof copyright owner f orrequired disposal for any other off-site. use.
The wastewater material collected from the first rinse during this cleaning process is then transported for off site disposal by appropriately licensed waste contractors.
With the effective implementation of this capture at source process, it has been determined that only 22.7gm of mercury will be discharged from the facility each year. The expected annual discharge from the facility is the equivalent of 4 human tooth fillings being discharged to the municipal sewer each year.
Irish Hydrodata Limited were commissioned by Elanco in 2012 to make an assessment of the fate of mercury discharging from the facility and to predict if the discharge from the Sligo WWTP would be within the environmental quality standards set in S.I. 272 of 2009 European Communities Environmental Objectives (Surface Waters) Regulations 2009, S.I. 268 of 2006 European Communities (Quality of Shellfish Waters) Regulations 2006 and S.I. 55 of 2009 European Communities (Quality of Shellfish Waters) (Amendment) Regulations 2009.
A number of numerical and analytical models were employed to estimate the levels of mercury in the Garavogue River Estuary resulting from the Elanco facility and taking into account the other municipal sources. It is considered that the models were generated on
Page 83 of 235
EPA Export 29-05-2012:04:39:43
IPPC Application Form V2/12 a conservative basis as they do not account for the expected further 90-95% reduction by adsorption which is generally accounted for when wastewaters reach the WWTP’s.
The predicted worst case peak mercury concentrations in the estuary waters from the various modelling methods have predicted that mercury levels arising from the combined discharge of other municipal sources (492gm/year) and the Elanco wastewater (22.7gm/year) will remain well below the environmental quality standards for priority hazardous substances.
Full details of the modelling assessment are provided in Attachment No. I.2 . However, in summary, an estimate of the mercury concentration in estuary waters was derived and it was predicted that average concentration levels of mercury in the Sligo WWTP discharge from the combined municipal and Elanco sources would be 0.00042ug/l.
I.3. ASSESSMENT OF IMPACT OF SEWAGE DISCHARGE.
Give summary details and an assessment of the impacts of any existing or proposed emissions on the environment, including environmental media other than those into which the emissions are to be made.
Sections I.2 (Assessment of Impact on Surface Waters) above is linked with Section I.3 (Assessment of the Impact on Sewage Discharge) as all process, surface and sanitary water are combined and discharged to the foul sewer.
These sections should therefore be considered in conjunction.
Sanitary wastewater will be collected in a separate collection system on site and will then be combined with the process water off site and conveyed directly to the Sligo WWTP.
Sanitary wastewater will comprise sewage and wastewater from:
Toilets; Washrooms; and Shower Facilities. For inspection purposes only. Consent of copyright owner required for any other use. Elanco discharges wastewater to the Local Authority sewer. The wastewater is then directed to Sligo WWTP.
The WWTP provides tertiary treatment and discharges to Garovogue River Estuary.
Elanco does not discharge to foul sewer any materials which could impact on the integrity of the sewer. Wastewater discharges are monitored to ensure compliance with the IPPC licence requirements and Sligo County Council have been consulted with regard to proposed wastewater emissions from the facility.
Full details of the assessment and any other supporting information should form Attachment No I.3.
Attachment No I.3. contains the 2001 letter from Corporation of Sligo granting the Fort Dodge Laboratories (now Elanco) approval for proposed revisions to the discharge limits from point SW1 Main Plant.
Elanco have initiated correspondence with Sligo County Council to advise of the IPPC Licence Review and the likely impact of the operation of the Stellamune facility.
Page 84 of 235
EPA Export 29-05-2012:04:39:43
IPPC Application Form V2/12
Sligo County Council have issued a letter consenting in principle to the proposal for a review of the IPPC licence, subject to: o The revised discharge parameters ensuring the protection of Sligo Bay and its environs. o The revised discharge parameters ensuring that this discharge shall have no negative impact on the bio-solids product from the Sludge Hub Centre at Sligo Main Drainage wastewater treatment plant, particularly in the context of its suitability for disposal by land spreading. o The revised licence conditions ensuring that appropriate controls and procedures are in place to prevent accidental or unauthorised discharges to the public sewer.
This letter has also been included in Appendix I.3.
I.4 ASSESSMENT OF IMPACT OF GROUND/GROUNDWATER EMISSIONS
Describe the existing groundwater quality. Tables I.4(i) should be completed.
Table I.4(i) is not applicable as there are no monitoring wells on site, and no requirement to monitor groundwater in the current IPPC licence for the facility.
Give summary details and an assessment of the impacts of any existing or proposed emissions on the ground (aquifers, soils, sub-soils and rock environment), including any impact on environmental media other than those into which the emissions are to be made. This includes landspreading, land injection etc.
There are no existing or proposed emissions from the site to ground or groundwater. The majority of the site is hardstanding and all surface water run off is collected in the site surface water drainage network and discharged to foul sewer.
The facility is located within the Drumcliff-Strandhill Groundwater Body (GWB: IE WE G 0076).
Under the Western River Basin District (RBD) Groundwater Action Programme (WFD, 2010) the Cummeen Strand/Drumcliff Bay SAC is a Groundwater Dependent Terrestrial For inspection purposes only. Ecosystem (GWDTE) linked to theConsent Drumcliff-Strandhill of copyright owner required for GWB. any other use. Under this action plan the Cummeen Strand / Drumcliff Bay (Sligo Bay) SAC GWDTE is currently classed as good but is at risk due to:
Diffuse pressures from the urban risk; and Groundwater quality risk.
Ground Water Distribution Groundwater levels are across the Drumcliff-Strandhill GWB are 0 – 5m below ground.
The average groundwater table encountered during the historic Ground Investigation (GI) at the facility was approximately 3m below ground level. This report is attached in Attachment N o I.5 .
Bedrock Aquifer The site is located on a locally important aquifer, moderately productive only in local zones (LI) as categorised by the GSI. Refer to EIS Volume 3: Drawings, Figure 9.3.
Under the GSI aquifer classification these types of aquifers (LI) have a limited and relatively poorly connected network of fractures, fissures and joints, giving a low fissure permeability which tends to decrease further with depth. A shallow zone of higher
Page 85 of 235
EPA Export 29-05-2012:04:39:43
IPPC Application Form V2/12 permeability may exist within the top few metres of more fractured/weathered rock, and higher permeability may also occur along fault zones. In general, the lack of connection between the limited fissures results in relatively poor aquifer storage and flow paths that may only extend a few hundred metres. Due to their low permeability and poor storage capacity, the aquifer has a low ‘recharge acceptance’.
There were no direct measurements of permeability testing completed during any historic site investigations.
Groundwater Flow The GSI Drumcliff-Strandhill Ground Water Body Description (GSI, 2004) which encompasses the area of the facility identifies that the flow paths within this aquifer are relatively short and are likely to be up to 300 m apart.
The description states that flow direction is typically toward the coastline, which would suggest a north or north easterly flow direction.
Groundwater Quality A Groundwater Protection Scheme is currently being prepared for County Sligo by the Geological Survey of Ireland. The overall aim of this scheme will be to preserve the quality of groundwater in County Sligo, particularly for drinking water purposes, for the benefit of present and future generations.
Local Groundwater Use Based on information from the Geological Survey of Ireland (GSI) published database there are no registered borehole abstractions within 3km of the site. The closest recorded borehole is approximately 4.5km south west of the site. It should be noted that it is not mandatory to register details of wells in Ireland, and it therefore remains possible that not all wells in the area have been registered.
A groundwater ”spring” is identified as being present approximately 2 km southwest of the site at Tobernaveen (www.gsi.ie). The yield class of the spring is classified as Intermediate, with a yield of 1,120m 3/day.
As regional groundwater flow follows the topography of the land, and flows towards the For inspection purposes only. coast the spring has not been furtherConsent ofevaluated. copyright owner required for any other use.
Groundwater Vulnerability Based on their Interim classification scheme, the GSI has classified the facility and the surrounding area as having a high vulnerability of the groundwater to pollution (GSI Interim classification – July 2010).
Land on which material may be landspread shall be identified on a suitable scaled map (1:10,560 and 1:50,000) and submitted as no greater than A3 size. All vulnerable (as a result of ground emissions) surface water bodies must be identified on these maps. Additional information should be included in Attachment No I.4 .
Attachment No I.4 . is not applicable. There are no landspreading activities associated with the Elanco facility.
Landspreading of Agricultural/Non Agricultural Wastes
Tables I.4(ii) and I.4.(iii) should be complete where applicable. Further information is available in the Application Guidance Document.
Tables I.4(ii) and I.4 .(iii) are not applicable. There are no landspreading activities associated with the Elanco facility.
Page 86 of 235
EPA Export 29-05-2012:04:39:43
IPPC Application Form V2/12
I.5 GROUND AND/OR GROUNDWATER CONTAMINATION
Summary details of known ground and/or groundwater contamination, historical or current, on or under the site must be given.
There are no known ground or groundwater contamination, historical or current at the facility.
The Geotechnical Investigation (GI) undertaken in October 2010 did not identify any areas of contamination.
Full details including all relevant investigative studies, assessments, or reports, monitoring results, location and design of monitoring installations, plans, drawings, documentation, including containment engineering, remedial works, and any other supporting information should be included in Attachment N o I.5 .
The GI Report is presented in Attachment N o I.5 .
This confirms that no contamination was found at the site.
I.6 ASSESSMENT OF THE ENVIRONMENTAL IMPACT OF ON-SITE WASTE RECOVERY AND/OR DISPOSAL.
Describe the arrangements for the prevention and recovery of waste generated by the activity.
As liquid waste in the form of process water is discussed previously in Section I.2 , only solid waste is discussed in this section.
Waste (Solid) - Prevention and Recovery Solid waste generated on site currently consists of non hazardous and hazardous waste.
Existing legislation and the legal requirements for the licensing of waste activities, in conjunction with the public awareness of environmental issues, are the driving forces towards sustainable development, energy For inspection conservatio purposes only.n and waste minimisation. Consent of copyright owner required for any other use.
Elanco has a well-developed waste management, minimisation and auditing strategy. This system is aimed at not only managing waste, but also at determining the most environmentally beneficial methods for controlling the generation of all wastes, and for reusing, recovering or disposing of them.
The approach adopted in this environmental assessment of solid waste is based on the following:
• Proximity Principle: the treatment of wastes as close to their source as possible in order to insure that the assimilative capacity of the area is not exceeded and to minimise the indirect effects of the creation of that waste. Adopting this approach will help mitigate against the offsite impacts associated with transport; and • The Waste Hierarchy: The cornerstone of all waste law is the aim of meeting, as far as is possible, a hierarchy of waste with policies and laws designed to promote measures as high up the hierarchy as possible.
Page 87 of 235
EPA Export 29-05-2012:04:39:43
IPPC Application Form V2/12
Materials used on site are generally stored only in volumes required for manufacturing and are not reordered until the quantities stored reach a low level to prevent additional waste streams.
Give details, and an assessment of the impact of any existing or proposed on-site waste recovery/disposal on the environment, including environmental media other than those into which the emissions are to be made.
The site operates under the existing Integrated Pollution Control Licence (P0090-01).
All off site recovery and disposal routes used are approved by the EPA in accordance with Section 7.1.1 of the IPPC Licence.
Non-Hazardous Waste Non hazardous waste arisings from site as recorded in the waste management records for the Elanco site in 2011 include; cardboard For inspection pack purposesaging, only. waste office paper, used Tyvek gowns, mixed dry recyclables, generalConsent of wastecopyright ownerand requiredwaste for plastic any other use.packaging.
The non hazardous waste going to landfill is collected and transported by waste approved contractor Greenstar. Greenstar also collect some non hazardous fraction for recycling such as dry mixed recyclables from the canteens of each of the four Elanco buildings.
Table I.6a outlined below reflects the solid non-hazardous waste streams generated at the facility.
Table I.6a Site Non Hazardous Waste Streams includes, but is not limited to:
EWC Waste Type Quantity (Metric Tons)
150101 Cardboard Packaging 20.080 150102 Waste plastic packaging 5.315 150106 Mixed Dry Recyclables 3.880 200101 Waste office Paper 8.555 200108 Compost 3.370 200140 Metal 5.960
Page 88 of 235
EPA Export 29-05-2012:04:39:43
IPPC Application Form V2/12
EWC Waste Type Quantity (Metric Tons)
200307 Bulk Waste 27.62 130503 Oily Water/Sludge - 191206* Wooden Pallets - 1606 Waste Batteries - - Waste suits, overshoes, hairnets and other - non-hazardous wastes from production and the canteen.
Hazardous Waste Hazardous Waste arisings on site consist of small quantities of chemicals used in the current manufacturing process and the cleaning of the production facility and its equipment. Also waste consumables arising from the manufacturing areas where animal biological agents are used and treated as potentially infectious, or bio hazardous waste. Waste electrical equipment (WEEE), batteries and fluorescent tubing were also sent off site in 2011 for recycling.
All Hazardous waste is transferred to AVG Ltd. for incineration under the authority of the Environmental Agency for the City of Hamburg or to Indaver NV thermal treatment facility in Belgium.
Waste consumables from the manufacturing areas where live animal biological agents have been used are treated as potentially infectious (Bio hazardous) wastes. These wastes are triple layer bagged and shipped in sealed U.N approved bins by SRCL- Ecosafe.
Table I.6b outlined below reflects the solid hazardous waste streams generated at the existing facility. It is envisaged that similar solid waste streams will continue to be produced by the facility.
Table I.6b Site Hazardous Waste Streams includes, but is not limited to: For inspection purposes only. Consent of copyright owner required for any other use. EWC Waste Type Quantity (Metric Tons) 060102 Hydrochloric Acid lab smalls 0.034 060106 Lab Waste (Acidic) 0.362 060204 Lab Waste (Caustic) 2.218 060205 Other bases 0.267 070501 Aqueous washing liquids 0.095 070504 Organic Solvent Waste (Isopropanol) 11.775 070513 Lab Waste (Contains dangerous substances) 0.997 080111 Waste Paint Tins 1.407 130208 Other engine, gear and lubricating oils 0.089 130310 Waste Refrigeration Oil 0.163 130701 Waste Fuel Oil 0.008 130899 Wastes not otherwise specified 0.020 150110 Empty Paint tins 0.014 150202 Wipes contaminated with oil 0.688 160211 Waste Electrical – Fridge / Freezer 0.905 160213 Waste Electrical – Mixed WEEE 2.659 160303 Inorganic wastes containing dangerous substances 0.013 160305 Organic Waste Containing dangerous substances 1.236
Page 89 of 235
EPA Export 29-05-2012:04:39:43
IPPC Application Form V2/12
EWC Waste Type Quantity (Metric Tons) 160504 Gases in pressure containers (including halons) containing dangerous substances 0.407 160506 Mixed lab chemicals (including mixtures) 5.231 160507 Mixed lab smalls (Inorganic) 0.079 160508 Mixed lab smalls (Organic) 3.206 160601 Lead batteries 0.970 180103 Reject product (Vaccines) 6.247 180202 Waste from processes involving live animal viruses and bacteria 29.046 191212 Other wastes (including mixtures of materials) from mechanical treatment of wastes other than those mentioned in 19 12 11 3.203 200121 Waste Electrical – Fluorescent Tubes 0.094 200133 Batteries and accumulators 0.340 200138 Wood other than that mentioned in 20 01 37 0.63 200139 Plastics 2.998 200301 Mixed municipal waste 37.68 Note 1 Waste HEPA filters from clean rooms - Note 1 Waste Aerosol Cans - Note 1 Waste Filters from Chemical fume hoods - Note 1 Waste absorbent material - Note 1 Oily water waste - Note 1: Defined as waste is generated
It is considered that the additional solid waste rates from the Stellamune extension will be in the region of approximately 30 metric tonnes per annum in total.
The CIP waste will fall under EWC 160508 “discarded organic chemicals consisting of or containing dangerous substances” and Elanco have confirmed with their licenced waste contractor that there is capacity for an increase in the volume of this waste for disposal.
There is no disposal of waste within the Elanco facility all wastes are removed off-site for For inspection purposes only. recovery or disposal. Consent of copyright owner required for any other use.
All volumes, off site recovery, disposal routes and relevant waste records relating to the Stellamune extension will be undertaken in accordance with current facility procedures, all legislative requirements and the requirements of the IPPC licence.
Elanco will ensure that the EPA, with regards to the IPPC licence, are kept fully informed of any material changes in the quantity, nature and characteristics of the waste streams resulting arising from the facility.
I.7 NOISE IMPACT
Give details and an assessment of the impacts of any existing or proposed emissions on the environment, including environmental media other than those into which the emissions are to be made.
The nearest residential properties are located approximately 0.22km south east of the proposed extension in the Rathedmond Estate. The Cummeen Strand /Drumcliff Bay (Sligo Bay) Special Area of Conservation lies approximately 0.7km to the north of the site.
Page 90 of 235
EPA Export 29-05-2012:04:39:43
IPPC Application Form V2/12
Weekday baseline noise measurements are undertaken every three years in accordance with the provisions of the current IPPC Licence. This noise data was last gathered at measuring positions which were considered representative of the nearest noise sensitive receptors on the 8th and 9th June 2010.
Daytime and night-time LA90 noise levels remained fairly consistent at 41 dB(A) during both the daytime and night-time surveys, while LA10 levels were 48 dB(A) and 51 dB(A) for the daytime and night-time periods respectively and LAeq levels varied between 46 dB(A) and 49 dB(A) respectively. These are below the license limit of 55 dB(A).
Ambient noise measurements
Complete Table I.7(i) in relation to the information required below:
(i) State the maximum Sound Pressure Levels which will be experienced at typical points on the boundary of the operation. (State sampling interval and duration)
(ii) State the maximum Sound Pressure Levels which will be experienced at typical noise sensitive locations, outside the boundary of the operation.
(iii) Give details of the background noise levels experienced at the site in the absence of noise from this operation.
Table I.7(i) is attached.
Prediction models, maps (no larger than A3), diagrams and supporting documents, including details of noise attenuation and noise proposed control measures to be employed, should form Attachment N o I.7 .
Attachment N o I.7 is not attached as Attachment N o F.2 presents the Environmental Noise Measurement, Elanco Animal Healthcare Facility, Finisklin Business Park, Co. Sligo, dated August 2010.
For inspection purposes only. Consent of copyright owner required for any other use.
Page 91 of 235
EPA Export 29-05-2012:04:39:43
IPPC Application Form V2/12
I.8 ENVIRONMENTAL CONSIDERATIONS AND BAT
Describe in outline the main alternatives, if any, to the proposals contained in the application.
There are no alternatives to the proposals contained in this application.
Describe any environmental considerations which have been made with respect to the use of cleaner technologies, waste minimisation and raw material substitution.
Elanco implement and are committed to their programme of continuous improvement on site with regard to environmental performance.
The facility has a well-developed waste management, minimisation and auditing strategy at the facility. This system is aimed at not only managing waste, but also at determining the most environmentally beneficial methods for controlling the generation of all wastes, and for reusing, recovering or disposing of them
Describe the measures proposed or in place to ensure that:
(a) The best available techniques are or will be used to prevent or eliminate or, where that is not practicable, generally reduce an emission from the activity;
Elanco – Programme of Environmental Management Elanco implement a programme of environmental management at the facility. As part of this programme, Elanco implement a programme of continuous improvement on site with regard to environmental performance and this programme is also integrated with Elanco’s commitment towards responsible energy management.
There are a variety of energy management and reduction programmes ongoing at the facility with ongoing plans to continuously review and improve the level of energy usage being consumed. Energy management is currently included as part of the environmental management programme to ensure that relevant objectives are set and performance is measured.
For inspection purposes only. Waste Management Consent of copyright owner required for any other use. Elanco has a well-developed waste management, minimisation and auditing strategy at the facility. This system is aimed at not only managing waste, but also at determining the most environmentally beneficial methods for controlling the generation of all wastes, and for reusing, recovering or disposing of them
Thimerosal - Management of Mercury Emissions to Sewer (SE2) Thimerosal is a mercury-containing organic compound (an organomercurial). Mercury is included as a List I dangerous substance under the Dangerous Substances Directive (2006/11/EC). It has been widely used as a vaccine preservative since the 1930s. Biological products in which the growth of a pathogenic organism is possible must contain a sufficient concentration of antiseptic (preservative) to inhibit bacterial growth.
Thimerosal is an integral component in the manufacturing processes at Elanco and is used at the Main Plant as a vaccine preservative.
With regard to environmental consideration and minimising the potential for environmental impact, it is noted that no primary materials containing mercury are discharged from the facility.
As detailed in Section E of the Application, the isolation and capture at source process of the CIP wastewaters is implemented at the Main Plant and it has been estimated that
Page 92 of 235
EPA Export 29-05-2012:04:39:43
IPPC Application Form V2/12 this process reduces the levels of mercury emissions in the CIP wastewater by 99.87% prior to discharge to the Local Authority combined sewer and subsequently the Sligo WWTP.
This process is implemented by capturing the CIP wastewater generated during the first cleaning rinse into suitable containers..
The wastewater material collected from the first rinse during this cleaning process is then transported for off site disposal by appropriately licensed waste contractors.
With the effective implementation of this capture at source process, it has been determined that only 22.7grams of mercury will be discharged from the Main Plant (SE1) to the sewer and Sligo WWTP each year. Although detailed information on the mercury content of other discharges to the Sligo WWTP was not available, it is estimated that this figure is in the region of 492 grams per year.
Detailed modelling and mass balance assessments were undertaken ( Attachment I.2) with regard to the final surface water receiving body (Garvogue River Estuary) and also with the management of sludge which is generated at the WWTP. These aspects are discussed in full in Section I.2 and H.2 of the Application respectively.
In summary, it was determined that the determined that the worst case peak mercury concentrations in the estuary waters from the various modelling methods have predicted that mercury levels arising from the combined discharge of municipal sources (492gm/year) and the Elanco wastewater (22.7gm/year) will remain well below the environmental quality standards for priority hazardous substances.
An estimate of the mercury concentration in estuary waters was derived and it was predicted that average concentration levels of mercury from the Sligo WWTP discharge (i.e., the combined municipal and Elanco sources) would be 0.00042ug/l.
(b) no significant pollution is caused;
Elanco adheres to the conditions of the current IPPC licence and monitors emissions to the atmosphere, sewer and noise in accordance with the provision of the current IPPC For inspection purposes only. licence with significant pollution Consenthave ofoccurred copyright owner to requireddate foron any site. other use.
(c) waste production is avoided in accordance with Council Directive 75/442/EEC of 15 July 1975 on waste; where waste is produced, it is recovered or, where that is technically and economically impossible, it is disposed of while avoiding or reducing any impact on the environment;
Elanco are committed to environmental improvement and in the area of waste management.
As detailed above, the facility has a well-developed waste management, minimisation and auditing strategy at the facility. This system is aimed at not only managing waste, but also at determining the most environmentally beneficial methods for controlling the generation of all wastes, and for reusing, recovering or disposing of them.
As detailed in Section H of the Application, all waste which are generated on site are managed in accordance with on site procedures and with the provisions of the IPPC Licence. Only approved and appropriately licensed waste contractors are procured on site.
Page 93 of 235
EPA Export 29-05-2012:04:39:43
IPPC Application Form V2/12
(d) energy and other resources are used efficiently;
As detailed in Section C , Elanco implement a programme of environmental management at the facility. As part of this programme, Elanco implement a programme of continuous improvement on site with regard to responsible energy management.
There are a variety of energy management and reduction programmes ongoing at the facility with ongoing plans to continuously review and improve the level of energy usage being consumed.
(e) the necessary measures are taken to prevent accidents and limit their consequences;
There is an Emergency Response Plan in place at the Elanco facility. The main objective of this plan is to prevent accidents and limit their consequences. Refer to Section J for full details on the on site requirements with regard to this plan.
(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.
A Residuals Management Plan is in place at the Elanco facility.
It is considered that the scope of this plan addresses the required measures to minimise the potential impact on the environment in the event of cessation of the Elanco operations including the Stellamune extension or cessation of part of the site operations.
Elanco intends to continue the successful and profitable operations of the facility at Finisklin for many years to come and has no current plans to decommission all or part of the site.
Please refer to Section K for full details.
Supporting information should form Attachment N o I.8.
Attachment N o I.8. Not Applicable . For inspection purposes only. Consent of copyright owner required for any other use.
Page 94 of 235
EPA Export 29-05-2012:04:39:43
IPPC Application Form V2/12
SECTION J: ACCIDENT PREVENTION & EMERGENCY RESPONSE
Describe the existing or proposed measures, including emergency procedures, to minimise the impact on the environment of an accidental emission or spillage.
Also outline what provisions have been made for response to emergency situations outside of normal working hours, i.e. during night-time, weekends and holiday periods.
Describe the arrangements for abnormal operating conditions including start-up, leaks, malfunctions or momentary stoppages.
Supporting information should form Attachment N o J. The most recent Emergency Response Plan (Revision 03) is attached in Attachment N o. J .
Emergency Response Plan
Elanco have developed an Emergency Response Plan to: Establish an integrated plan for emergency situations; Respond to emergencies; Limit the severity of emergencies when they do happen; and Ensure that designated employees are aware of their responsibilities for implementation of planned emergency response.
The Plan outlines the roles and responsibilities of Elanco staff in the event of an emergency. This includes contingencies in the event that an emergency situation occurs outside of normal working hours.
Overall responsibility for the Emergency Action Plan lies with the Environmental Health and Safety Office. In this capacity the EHS Officer therefore fulfils the role of both the Site Emergency Coordinator and of Spill Coordinator. If the Site Emergency Coordinator is not present at the facility, the For designated inspection purposes back only.up acts as the Site Emergency Coordinator. Consent of copyright owner required for any other use.
The Emergency Response Plan also includes procedures for fire system sprinkler leakage, underground piping leakage, public water supplies disruption and electrical power outages.
It is recognised that the Elanco Facility is immediately surrounded by a mainly industrial environment with the more urban environs of Sligo City Centre located approximately 1.7km from the Main Plant. The main industrial properties surrounding the proposed extension include those from the healthcare, medical packaging, food storage and engineering background. The nearest residential properties are located approximately 0.2km south east of the Main Plant in the Rathedmond Estate. The Cummeen Strand /Drumcliff Bay (Sligo Bay) Special Area of Conservation lies approximately 0.7km to the north of the site.
The Plan includes a procedure for handling unplanned discharges and chemical spills. A Spill Response Coordinator is appointed for the facility. In the event of a spillage, the Spill Response Coordinator is responsible for the immediate coordination and response to major chemical and/or biological spills on site. The Spill Response Coordinator works directly with the Site Emergency Coordinator in a major spill situation.
Page 95 of 235
EPA Export 29-05-2012:04:39:43
IPPC Application Form V2/12
In the event of an unplanned discharge (discharges from plant systems to the air, storm water, or sewer system that are not normal and would require reporting to community and government authorities) the EHS Officer or designee is contacted.
Discharges to the storm water system are prohibited on site. If a discharge is identified, the EHS Officer or designee will contact area personnel to attempt to stop the discharge and will determine which outside authorities need to be contacted as indicated by the EPA IPPC licence.
If an unplanned discharge to air is identified the EHS Officer or designee will contact area personnel to attempt to stop the discharge and will contact the appropriate authorities for all discharges, which require EPA telephone and/or written reporting. Certain events must be reported to Sligo County Council, Sligo Corporation and the EPA, by telephone and fax as soon as practicable after the occurrence.
Sewer discharges are unplanned discharges to the sewer system or any discharges to the sewer system that are not called for in the IPPC Licence. The EHS Officer or designee will contact area personnel to attempt to stop the discharge. The EHS Officer will determine whether outside authorities need to be contacted. The City of Sligo Wastewater Treatment Plant may require immediate notification by phone and fax of any discharge that may prevent proper treatment of wastewater in their facility or endanger their personnel. A written report must be submitted as soon as is practicable to the EPA and Sligo Borough Council.
Chemical spills are defined in the Plan as spills of any chemical, which would cause a physical hazard to personnel, equipment, or health hazard to personnel. All chemical spills to the environment not specifically permitted must be immediately reported to the EHS Officer or designee. The EHS Officer or designee immediately contacts the spill response team, responds to the area and assumes the Site Emergency Coordinator position and determines if Regulatory notification is required. After a survey of the scene, the EHS Manger or designee determines the type of action necessary to prevent the spill from entering floor drains, ground, groundwater or storm water. At the same time the spill scene is barricaded to prevent unauthorized personnel from entering. Depending on the size, hazard and chemical spilled the EHS Manger either sends qualified personnel to the spill site to contain and clean up the spill, or contacts the spill response team. Spill For inspection purposes only. response follows procedures Consent for spillof copyright cleanup owner required eithe for anyr other from use. established company procedures and/or from specific procedures listed on the Material Safety Data Sheet (MSDS).
All buildings at the Elanco facility are secured by swipe access. No member of the public or visitors can access the buildings without being accompanied by a member of the Elanco staff. Chemicals in use at the facility are stored in dedicated containers or storage tanks. Storage containers and tanks are bunded to retain the contents in the event of a spill. Chemicals are segregated according to their individual properties and individual storage requirements. Further details of the storage of raw materials and products can be found in Section H. Section H also includes details of the storage of fuel on-site and the containment of potential spills through bunded structures.
Outside of normal working hours the facility is monitored at night and at weekends by a mobile security team from SM Security, who patrol the Finisklin Industrial Estate. Intruder, fire and sprinkler alarms are monitored 24 hours a day, 7 days a week by Power Right. In the event of an emergency Power Right contact the appropriate out of hours Elanco contact and/or the emergency services.
A sprinkler/firewater holding tank is located adjacent to the Stellamune Extension site. Full details of the firewater system are outlined in Section D.
Page 96 of 235
EPA Export 29-05-2012:04:39:43
IPPC Application Form V2/12
Further details of the Spill Response Procedure can be found in the Elanco Animal Health Ireland Limited Emergency Response Plan Revision 03 included in Attachment N o J .
A copy of the Public/General Liability Insurance Cover is provided in Attachment B.5
For inspection purposes only. Consent of copyright owner required for any other use.
Page 97 of 235
EPA Export 29-05-2012:04:39:43
IPPC Application Form V2/12
SECTION K: REMEDIATION, DECOMMISSIONING, RESTORATION & AFTERCARE
Describe the existing or proposed measures to minimise the impact on the environment after the activity or part of the activity ceases operation, including provision for post- closure care of any potentially polluting residuals.
Supporting information should be included as Attachment No. K. No supporting information is attached.
Residuals Management Plan (RMP)
A Residuals Management Plan (RMP) has been developed for the Elanco site. It is considered that the scope of this plan addresses the required measures to minimise the potential impact on the environment in the event of cessation of the Elanco operations including the Stellamune extension or cessation of part of the site operations.
Elanco intends to continue the successful and profitable operations of the facility at Finisklin for many years to come.
Elanco has no current plans to decommission all or part of the site. However, the basis of the Plan is to ensure that upon implementing the RMP, the facility and site would be in a suitable state for future industrial use and its condition would not pose a risk to public health or environmental condition. In general, it is envisaged that specialist equipment will be distributed to sister plants in the event of a shutdown.
Elanco intends to utilise existing internal resources to manage and execute the RMP, supplemented where appropriate by external resources. The Residuals Management Team would be responsible for managing and executing the complete RMP. Outside contractors required for cleaning, waste disposal, incineration or recycling activities would be fully approved and licensed.
It is estimated that the duration of the decommissioning and decontamination of the site operations would be approximately 3-6 months. Environmental monitoring would continue for while the RMP is in operation For inspection and up purposes to 3only. months following the completion of the Plan. Consent of copyright owner required for any other use.
The EPA and the local authority would be informed of the results of the monitoring programme and of the status of the RMP.
Particular actions are listed for specific areas of the facility as part of the RMP. In general care and attention will be given during the implementation of the RMP to ensure that the potential risks associated with the Plan are avoided.
In the event of a spillage, leak or fire during the decommissioning period, the Elanco Emergency Response Plan would be fully implemented in order to minimise the risk to health and the environment.
A description of the main actions for each of the main areas related to the Elanco operations in Finisklin is provided below.
The RMP for all storage areas and warehouse would consist of the following actions: Cancellation of all incoming materials to site. Negotiate with sister plants with a view to distribute unused materials or sale to another interested party or otherwise for disposal by an approved and licensed contractor.
Page 98 of 235
EPA Export 29-05-2012:04:39:43
IPPC Application Form V2/12
Negotiation with relevant vendors to return unused materials to supplier. Send opened containers and un-returnable or out-of-date goods for waste disposal, using an approved licensed contractor. Cleaning and decontamination of the store. Existing procedures would be sufficient for the operations. Specific procedures would be developed, if required. The state of the cleanliness would be verified either analytically or through a process of visual inspection.
The RMP for the QC Building areas would consist of the following actions: Completion of all necessary analytical work on the production in progress and final products before removal. Return to vendor or sell on all unopened and in-date laboratory chemicals. Removal of all opened chemical containers and out of date chemicals for disposal, in conjunction with an approved and licensed waste contractor. Cleaning and decontamination of laboratories and laboratory instruments contained in them. Cleaning and decontamination of all glassware, storage areas, waste systems and any other equipment and systems. Shutting down of all computer systems other than those deemed essential for ongoing monitoring of the area. Transfer of specialised equipment to sister plants or sale to similar facility. Recycling of obsolete equipment, if possible, otherwise disposal by approved and licensed contractor.
The RMP for the utilities would consist of the following actions: The shutting down of systems on a phased basis, depending on plant status and requirements: Steam Boilers - it is likely that only one boiler would be required during the decommissioning period and subsequently for any ongoing heating requirements. The remaining units would be shutdown and disconnected For inspection purposes only. from the steamConsent distribution of copyright owner system. required for The any other boilers use. would be cleared of
residues and the fuel lines cleaned and blanked off. Condensate systems would be drained, cleaned and left in a safe state. Removal of any associated chemicals, oils or any other materials in utilities area, in the Main Plant/QC Building for redistribution or return to the vendor for disposal, if required. The water supply system servicing the facility would be maintained due to the needs for fire protection and sanitary services.
The RMP for the maintenance and engineering areas would include the following actions: The secure archiving of all engineering documentation including drawings, process and instrumentation diagrams (P&ID), validation documentation, vendor manuals & data, project files, maintenance records, inspection records and all other appropriate documentation. Disconnection of all maintenance equipment to leave it in a secure state. Distribution of equipment to a sister facility or sale to another interested party or otherwise for disposal by an approved and licensed contractor.
Page 99 of 235
EPA Export 29-05-2012:04:39:43
IPPC Application Form V2/12
Removal of all old and obsolete equipment including maintenance equipment from workshop areas and stores for recycling or otherwise for disposal by an approved and licensed contractor.
The RMP for the reception, administration, canteen & security areas would include the following actions: Removal of administration and reception equipment for distribution to a sister facility, where possible or otherwise for disposal by an approved and licensed contractor. Removal of canteen equipment for distribution to a sister facility where possible, sale to an interested party or otherwise for disposal by an approved and licensed contractor. The maintenance of a security presence for ongoing monitoring of the site from a safety, fire prevention and environmental perspective will be organised.
The following other actions would be required to ensure the implementation of the RMP on a site-wide basis: Cessation of all construction project work on-site so that the various sites are left in an orderly condition. Disbandment of contract personnel, facilities and equipment. Termination of all non-essential maintenance and other contracts. Removal from site of any temporary offices and storage units. Continuation of ongoing programmes to ensure the integrity of receiving mains water supply. Rationalisation of the site electricity supply. This would involve removing transformers from service and allowing the remainder site operations to run from one transformer. The redundant transformers would be made free of oils. Given current site conditions, contamination of soils from Elanco site operations is not expected. However, an assessment of soils at the time For inspection purposes only. of decommissioningConsent of would copyright owner be maderequired for and any other any use. necessary remediation carried out, in liaison with the EPA. Maintenance of all necessary fire alarm and fire protection systems. Maintenance of security, video monitoring and defined site access procedures. Cleaning of all underground fuel oil pipe-work as per normal procedures. Removal of all items that may contain mercury (for example fluorescent lights) or any other controlled compounds for recycling or disposal with licensed and approved contactors, if necessary.
It is noted that the QC Building roof area contains asbestos. However, demolition or any alteration works are not envisaged during the decommissioning of the site. In the event that such works would be required, appropriate procedures will be developed prior to be commencement of any work for agreement with the EPA. Additionally, with regard to the disposal of asbestos off site, only licensed and approved waste contractors will be procured.
A schedule of post-decommissioning environmental monitoring will be agreed with the EPA in the event that the facility ceases activity.
Page 100 of 235
EPA Export 29-05-2012:04:39:43
IPPC Application Form V2/12
Decommissioning of Equipment – (SOP 01-016-00 – Decommissioning of Obsolete Equipment)
Elanco maintain a Procedure for the Decommissioning of Obsolete Equipment (SOP: 01- 016-00). This outlines the procedure that must be followed when a piece of equipment is being removed from operation at the facility and identifies the responsibilities of the relevant Elanco personnel.
The procedure outlines that the responsible department must get approval to dispose of a company asset.
A survey of the equipment is conducted to identify any hazards that may be encountered when removing it. The EHS officer may be consulted at this stage.
The Engineering Manager lists any services that need to be isolated and ensures that the item of equipment is removed from preventative maintenance schedules and calibration schedules.
Equipment is removed and disposed of and all certificates of disposal/recycling are filed and maintained on site.
Costs
It is estimated that the resources below would be required for a period of 1-6 months to successfully implement the Residuals Management Plan. The estimated costs associated for these resources are 150,000 euro.
Role Staff Numbers Management 1 Operations\Engineering 4 Laboratory 2 Others 1 Total 8
For inspection purposes only. Consent of copyright owner required for any other use. In addition external support would also be needed to implement the plan. The external contract support estimated to be required is outlined in the following table
Role Cost Euros Contract Cleaning and 500,000 Decontamination Incineration and Disposal 300,000 Civil Works 20,000 Electrical, IT works 10,000 Logistics and Transport 20,000 Other/ Contingency 20,000
Total 870,000
Therefore the total costs estimated to be required to execute the residuals management plan at 2009 value would be in the region of € 1,020,000.
In addition to the above, post-decommissioning environmental monitoring agreed with the EPA will involve a cost.
Page 101 of 235
EPA Export 29-05-2012:04:39:43
IPPC Application Form V2/12
The following assumptions were made in estimating the likely costs involved:
The process and operations at the facility do not give rise to any reasonable probability that site remediation in the form of groundwater or soil cleanup would be a likely event The site would be left in a clean condition, i.e. decontaminated and certified as being free of any biological or chemical hazard. All buildings would be retained. All bulk materials and process intermediates and products would be removed. No liabilities would be incurred due to activities of contractors storing and disposing of materials removed from the Elanco site. No civil liabilities would be incurred as a result of third parties alleging environmental damage arising from the operational phase or closure. The maximum asset value of the facility would be maintained but no action would be taken to prepare the site for a trade sale as a going concern or otherwise Normal practice would be maintained to minimise ongoing liabilities and to fulfil insurance requirements It is assumed that the planning authority would not take any action to prevent site dereliction, as the existing facilities would be maintained in a condition suitable for future beneficial use
In addition no factors have been identified that would indicate any other unusual liability for the site.
For inspection purposes only. Consent of copyright owner required for any other use.
Page 102 of 235
EPA Export 29-05-2012:04:39:44
IPPC Application Form V2/12
SECTION L: STATUTORY REQUIREMENTS
Indicate how the requirements of Section 83(5)(a)(i) to (v) and (vii) to (x) of the EPA Acts, 1992 and 2011 shall be met, having regard, where appropriate, to any relevant specification issued by the Agency under section 5 (3) of the Act and the reasons for the selection of the arrangements proposed.
Indicate how the requirements of Section 83(5)(a)(i) to (v) and (vii) to (x) of the EPA Acts, 1992 and 2003 shall be met, having regard, where appropriate, to any relevant specification issued by the Agency under section 5 (3) of the Act and the reasons for the selection of the arrangements proposed.
Section 83(5) The Agency shall not grant a licence or revised licence for an activity— (a) unless it is satisfied that— (i) any emissions from the activity will not result in the contravention of any relevant air quality standard specified under section 50 of the Air Pollution Act 1987, and will comply with any relevant emission limit value specified under section 51 of the Air Pollution Act 1987,
As referenced in Section I, the air quality of the area surrounding the Elanco facility is described by the EPA as being very good. As part of the Environmental Impact Assessment, for the Stellamune Extension to the Elanco Animal Health Facility, Sligo, the facilities emissions to air were assessed.
It was considered that that the pollutant concentrations resulting from the operation of the facility including the Stellamune extension will fall well within the Air Quality Standards.
The addition of the Stellamune Extension to the existing facility will result in a minor increase in the level of traffic during the operational phase of the facility (10-15 additional staff cars per day). In terms of air quality, this may result in a minor rise in air pollutants in the immediate vicinity of the road into the Main Plant. Given the current air quality in the area and the minor increase in additional traffic accessing the site during the operational phase, the impact from For traffic inspection will purposes therefore only. have no significant effect and Consent of copyright owner required for any other use. the resulting pollutant concentrations are expected to fall well within the Air Quality Standards
The facility will require additional energy for the production process to facilitate the Stellamune extension. However, this increase is not considered to be significant and the impact is considered to have no significant effect on climate change.
All emissions to air from the facility are monitored in accordance with the provisions of the current IPPC licence and these results are reported to the Agency in quarterly and annual environmental reports.
There are no odour releasing issues with any of the materials used in the process and the manufacturing areas are contained within a closed system.
(ii) any emissions from the activity will comply with, or will not result in the contravention of, any relevant quality standard for waters, trade effluents and sewage effluents and standards in relation to treatment of such effluents prescribed under section 26 of the Local Government (Water Pollution) Act 1977,
Page 103 of 235
EPA Export 29-05-2012:04:39:44
IPPC Application Form V2/12
All emissions to sewer from the facility are monitored in accordance with the provisions of the current IPPC licence and these results are reported to the Agency in quarterly and annual environmental reports.
At the Main Plant and QC Building, the wastewater discharge is monitored downstream of a pH monitoring unit prior to its discharge to foul sewer.
At the Main Plant there is continuous monitoring of pH, flow and temperature. Water samples are also tested on a weekly, monthly, quarterly and annual basis for a range of parameters in line with the requirements of the current IPPC licence. At the QC building there is a chart recorder monitoring pH and flow and a grab sample is collected when the intermittent flow is available.
As per Condition 4 of the existing IPPC licence (P090-01) Elanco will notify the EPA by telephone and facsimile to the Agency’s Headquarters in Wexford, or to such other Agency office as may be specified by the Agency, as soon as practicable after the occurrence of any of the following: Any release to atmosphere from any potential emission point. Any emission which does not comply with the requirements of this licence. Any malfunction or breakdown of control equipment, monitoring equipment or sampling equipment which is likely to lead to loss of control of any abatement system. Any incident with the potential for environmental contamination of surface water or groundwater, or posing a threat to land, or a sanitary authority sewer or personnel working in connection with a sewer, or requiring an emergency response by the local authority.
Elanco make a record of any incident as set out in condition 4.1 (detailed above), the notification given to the Agency and all actions taken to minimise the effect on the environment and minimise wastes generated.
In the event of any incident with the potential for environmental contamination of surface water or groundwater, or posing For inspectiona threat purposes to land, only. or a sanitary authority sewer or Consent of copyright owner required for any other use. personnel working in connection with a sewer, or requiring an emergency response by the local authority. having taken place, Elanco shall notify the sanitary authority as soon as is practicable, after such an incident.
In the event of any exceedences of the IPPC licence limits, these are reported to the EPA in the QERs and AERs. Additionally, in the event of any exceedances, these are reported to the EHS Department and are corrective/preventative measures are appropriately implemented.
There are no direct emissions to groundwater and the possibility of accidental indirect emissions is minimised by on site operational measures, including but not limited to the bunding of fuel storage tanks, the correct storage of process materials and the presence of the Stellamune firewater retention tank.
(iii) any emissions from the activity or any premises, plant, methods, processes, operating procedures or other factors which affect such emissions will comply with or will not result in the contravention of, any relevant standard including any standard for an environmental medium prescribed under regulations made under the European Communities Act 1972, or under any other enactment,
Page 104 of 235
EPA Export 29-05-2012:04:39:44
IPPC Application Form V2/12
Elanco operates in compliance with the standards prescribed in the current IPPC licence to ensure that measures for environmental compliance and management are appropriately implemented.
The EHS Department are responsible for the review and assessment of environmental legislation. The EHS Department review new legislation against the existing licence limits and current emission data and where required will implement environmental programmes to ensure ongoing compliance.
With specific regard to the presence of levels of mercury and its compounds in the wastewaters discharged from the facility, Sections E and I have demonstrated that levels discharged from the site are low and will not results in any contravention of relevant environmental standards to specifically include the following:
• Priority Substance Directive 2008/05/EC; • Dangerous Substance Directive 2006/11/EC; • Water Framework Directive 2000/60/EC • Urban Wastewater regulations; and • Surface water Regulations
(iv) any noise from the activity will comply with, or will not result in the contravention of, any regulations under section 106,
In accordance with the provisions and conditions of the current IPPC licence, the emissions from the facility shall not give rise to sound pressure levels at noise sensitive locations near the activity which exceed 55dBA (Leq 15 minutes) during the daytime and 45 dBA (Leq 15 minutes) during the night time.
A noise survey is carried out every 3 years under on the current licence conditions to ensure the activity does not contravene the noise emission limits. The most recent environmental noise survey, dated 2010 and which demonstrates compliance with the IPPC licence conditions is attached in Attachment N o. F.2.
(v) any emissions from the activity will not cause significant environmental pollution,
For inspection purposes only. Elanco implement a programme Consentof environmental of copyright owner required manag for anyement other use. at the facility. As part of this programme, Elanco implement a programme of continuous improvement on site with regard to environmental performance.
Elanco operates in compliance with the standards prescribed in the current IPPC licence to ensure that measures for environmental compliance and management are appropriately implemented.
(vii) having regard to Part III of the Act of 1996, production of waste in the carrying on of the activity will be prevented or minimised or, where waste is produced, it will be recovered or, where that is not technically or economically possible, disposed of in a manner which will prevent or minimise any impact on the environment,
Elanco has a well-developed waste management, minimisation and auditing strategy.
This system is aimed at not only managing waste, but also at determining the most environmentally beneficial methods for controlling the generation of all wastes, and for reusing, recovering or disposing of them. Full details on this system are presented in Section H and Section I .
Page 105 of 235
EPA Export 29-05-2012:04:39:44
IPPC Application Form V2/12
(viii) energy will be used efficiently in the carrying on of the activity, There are a variety of energy management and reduction programmes ongoing at the facility. As an element of the overall environmental management programme at the facility and with the overall aim of continuous improvement in environmental performance and responsible energy management, there are ongoing plans to continuously review and improve the level of energy usage being consumed by the facility. Full details on energy management and efficiency are presented in Section G .
(ix) necessary measures will be taken to prevent accidents in the carrying on of the activity and, where an accident occurs, to limit its consequences for the environment and, in so far as it does have such consequences, to remedy those consequences, Elanco have developed an Emergency Response Plan to: Establish an integrated plan for emergency situations Respond to emergencies Limit the severity of emergencies when they do happen; and Ensure that designated employees are aware of their responsibilities for implementation of planned emergency response.
A copy of the Elanco Animal Health Ireland Limited Emergency Response Plan Revision 02 is included in Attachment N o J.
(x) necessary measures will be taken upon the permanent cessation of the activity (including such a cessation resulting from the abandonment of the activity) to avoid any risk of environmental pollution and return the site of the activity to a satisfactory state.
In the event of permanent cessation of the activity at the facility, Elanco will implement their Residuals Management Plan which has been developed in accordance with the current IPPC licence conditions.
The Plan outlines the steps necessary for the successful decommissioning of the activity, or part thereof, to ensure minimum impact to the environment. The Residuals Management Plan is discussed in more detail in Section K .
Indicate whether or not the activity is carried out, or may be carried out, or is located such that it is liable to have an adverse effect on - For inspection purposes only. (a) a site placed on a list inConsent accordance of copyright ownerwith required Chapter for any 1 other of use.SI 94 of 1997, or (b) a site where consultation has been initiated in accordance with Article 5 of the EU Habitats Directive (92/43/EEC), or
The activities carried out at the facility will not have an adverse impact on
(a) a site placed on a list in accordance with Chapter 1 of SI 94 of 1997, (b) a site where consultation has been initiated in accordance with Article 5 of the EU Habitats Directive (92/43/EEC).
The facility lies within 5km of the following designated areas:
Cummeen Strand/Drumcliff Bay (627) Special Area of Conservation (SAC) and proposed Natural Heritage Area (pNHA) Lough Gill (1976) SAC and pNHA Cummeen Strand Special Protection Area (SPA) (4035) Knocknarea Mountain And Glen (1670) pNHA
As part of the Environmental Impact Assessment, for the Proposed Extension to the Elanco Animal Health Facility, Sligo, consultation was carried out with the National Parks and Wildlife Service (NPWS) and Inland Fisheries Ireland.
Page 106 of 235
EPA Export 29-05-2012:04:39:44
IPPC Application Form V2/12
An Appropriate Assessment (AA) Stage 1 Screening Report was developed as part of the planning application and EIS for the Proposed Extension (Stellamune). Additionally, an AA Stage 1 Screening Report was developed in May 2012 addressing the facility as a whole.
In summary the Screening Reports determined that the facility would not have an adverse impact on the Natura 2000 sites either alone or in combination.
Attachment B.5 contains a copy of the AA Stage 1 Screening report prepared for Elanco Sligo facility (May 2012).
Indicate whether or not the activity is liable to have an adverse effect on water quality in light of S.I. No. 258 of 1998 (Local Government (Water Pollution) Act, 1977 (Water Quality Standards for Phosphorus) Regulations, 1998).
There shall be no adverse effect on water quality in light of S.I. No. 258 of 1998. Elanco does not discharge directly to any surface water bodies.
Indicate whether any of the substances specified in the Schedule of the EPA (Licensing) (Amendment) 2004, S.I. 394 of 2004, are discharged by the activity to the relevant medium.
The Environmental Protection Agency (Licensing) (Amendment) Regulations 2004 (S.I. 394 of 2004) specify indicative lists of principal polluting substances to be taken into account by the Agency, if relevant, in the fixing of emission limit values.
The table below lists the polluting substances for Air and Water that are given in the Schedule to these regulations, with an indication of whether they are likely to be present in air and water emissions at Elanco (Sligo).
Medium Principal Polluting Substance Elanco Sligo Emissions Air Sulphur dioxide and other sulphur Present compounds Air Oxides of nitrogen and other Present For inspection purposes only. nitrogen compoundsConsent of copyright owner required for any other use. Air Carbon monoxide Present Air Volatile organic compounds Present (Isopropanol) Air Metals and their compounds Unlikely to be present Air Dust Unlikely to be present Air Asbestos (suspended particulates, Unlikely to be present fibres) (It is noted that Asbestos has been found in the QC Building and in the event of demolition or alteration works appropriate procedures will be developed, prior to the commencement of works, for agreement with the EPA. It is not considered that the material is likely to become friable in its current state.) Air Chlorine and its compounds Unlikely to be present Air Fluorine and its compounds Unlikely to be present Air Arsenic and its compounds Unlikely to be present Air Cyanides Unlikely to be present
Page 107 of 235
EPA Export 29-05-2012:04:39:44
IPPC Application Form V2/12
Air Substances and preparations Unlikely to be present which have been proved to possess carcinogenic or mutagenic properties or properties which may affect reproduction via the air Air Polychlorinated dibenzodioxins and Unlikely to be present polychlorinated dibenzofurans Water Organohalogen compounds and Organohalogen compounds are substances which may form such used at the facility and could compounds in the aquatic potentially be present in trace environment quantities Water Organophosphorus compounds Unlikely to be present Water Organotin compounds Unlikely to be present Water Substances and preparations Substances and preparations which have been proved to which have been proved to possess carcinogenic or mutagenic possess carcinogenic or properties or properties which may mutagenic properties or affect reproduction in or via the properties which may affect aquatic environment reproduction in or via the aquatic environment are used at the facility and could potentially be present in trace quantities Water Persistent hydrocarbons and Potentially be present in low persistent and bio-accumulable quantities organic toxic substances Water Cyanides Unlikely to be present Water Metals and their compounds Present Water Arsenic and its compounds Unlikely to be present Water Biocides and plant health products Biocides are used at the facility and could potentially be present in extremely low quantities Water Materials in suspension Present Water Substances which For contribute inspection purposes to only. Present Consent of copyright owner required for any other use. eutrophication (in particular, nitrates and phosphates) Water Substances which have an Present unfavourable influence on the oxygen balance (and can be measured using parameters such as BOD, COD, etc.).
Elanco does not discharge directly to any surface water bodies.
All emissions to sewer from the facility are monitored in accordance with the provisions of the current IPPC licence and these results are reported to the Agency in quarterly and annual environmental reports.
Fit and Proper Person
The PoE Act in Section 83(5)(xi) specifies that the Agency shall not grant a licence unless it is satisfied that the applicant or licensee or transferee as the case may be is a fit and proper person. Section 84(4) of the PoE Act specifies the information required to enable a determination to be made by the Agency.
Page 108 of 235
EPA Export 29-05-2012:04:39:44
IPPC Application Form V2/12
• Indicate whether the applicant or other relevant person has been convicted under the PoE Act, the Waste Management Act 1996, the Local Government (Water pollution) Acts 1977 and 1990 or the Air Pollution Act 1987.
• Provide details of the applicant’s technical knowledge and/or qualifications, along with that of other relevant employees.
• Provide information to show that the person is likely to 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.
Supporting information should be included as Attachment N o L with reference to where the information can be found in the application.
Absence of Convictions Neither Dr. Glynn or Mr. Monaghan have been convicted under the Protection of the Environment Act 2003, the Waste Management Act 1996, the Local Government (Water Pollution) Acts 1977 and 1990 or the Air Pollution Act 1987.
Applicants Technical Knowledge / Fit and Proper Person
EHS Team The Environmental, Health and Safety Team primarily comprises an EHS Officer and EHS Specialist, both of whom possess the necessary technical knowledge, experience and qualifications appropriate to the role.
The relevant qualifications and experience of the Plant Manager, Plant EHS Officer and EHS Specialists are detailed in Table L.1.
Table L.1 Qualifications of Elanco Plant Manager and EHS Officer.
Description Fit and Proper EHS Officer EHS Specialist Person For inspection purposesMr. only. Paul Name Dr. PatConsent Glynn of copyright owner required for any other use. Ms. Cheryl O’Hara Monaghan MSc BSc. Hons in Environmental Environmental Protection - Science and Relevant PhD Microbiology 2007 Technology Qualifications (Genetics) – 1991 PgD MSc. Hons in Environmental Environmental Protection – Health and Safety 2005 Management Head of Operations - EHS Officer: EHS Specialist: 1998 Aug-2008 Mar-2009 Prod/Quality Manufacturing EHS Specialist: Relevant Management: Since Oct 2005 – Mar Jan – 2005 Experience 1992 2009 Overall site Prod/Validation: responsibility for EHS - Since May 1996 since 1992
Page 109 of 235
EPA Export 29-05-2012:04:39:44
IPPC Application Form V2/12
Elanco Workforce Elanco is a global, innovation-driven company that develops and markets products to improve animal health and protein production in more than 75 countries. Elanco employs more than 2,300 people worldwide, with offices in more than 40 countries.
The facility at Finisklin has been in operation since 1991 and has expanded operations on site on a phased basis to include administration, quality control laboratory and labelling and packaging properties.
The company therefore has significant experience and technical capability in the pharmaceutical industry, provided by a highly trained workforce who possess the necessary qualifications, experience and technical competence in their respective areas of responsibility.
These resources have ensured that the site has operated successfully under the existing IPPC Licence since October 1996. Although Elanco purchased the site in 2009, the persons in Table L.1 served in these capacities for the prior site owners.
Further details on the breakdown of the Elanco Site Management and relevant systems which are implemented on site and which contribute towards maintaining environmental compliance are presented in Section C .
Provide information to show that the person is likely to be in a position to meet any financial commitments or liabilities
Attachment N o L contains the Certificate of Insurance.
For inspection purposes only. Consent of copyright owner required for any other use.
Page 110 of 235
EPA Export 29-05-2012:04:39:44 For inspection purposes only. Consent of copyright owner required for any other use.
EPA Export 29-05-2012:04:39:44
IPPC Application Form V2/12
ANNEX 1: TABLES/ATTACHMENTS
For inspection purposes only. Consent of copyright owner required for any other use.
Page 112 of 235
EPA Export 29-05-2012:04:39:44
IPPC Application Form V2/12
Table E.1 (i) BOILER EMISSIONS TO ATMOSPHERE (1 Page for each emission point)
Emission Point: Emission Point Ref. N o: A1-1 (Boiler 1)
Location: Main Plant
Grid Ref. (12 digit, 6E,6N): 567790, 836493
Vent Details Diameter: 0.43m Height above Ground(m):6.3m
Date of commencement of emission: 2000
Characteristics of Emission: Boiler rating Steam Output: 3,000 kg/hr Thermal Input: 2.145 MW Boiler fuel Type: Oil Fired Dennis Baldwin MX3000 Maximum rate at which fuel is burned 5000 kg/hr % sulphur content: Low sulphur fuel NOx 199.1 mg/Nm 3 o 0 C. 3% O 2(Liquid or Gas), 6% O 2(Solid Fuel) Maximum volume* of emission m3/hr o For inspection purposes only. 0 C, 3 % O 2 (liquid or gas), 6 % O 2 (solid fuel) Consent of copyright owner required for any other use. Minimum efflux velocity
Temperature 250 oC(max) 183-192 201 oC(avg) oC(min)
* Volume flow limits for emissions to atmosphere shall be based on Normal conditions of temperature and pressure, (i.e. 0 oC,101.3kPa), dry gas; 3% oxygen for liquid and gas fuels; 6% oxygen for solid fuels.
(i) 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 60 min/hr 24 hr/day 365 day/yr (avg)
Page 113 of 235
EPA Export 29-05-2012:04:39:44
IPPC Application Form V2/12
Emission Point: Emission Point Ref. N o: A1-2 (Boiler 2)
Location: Main Plant
Grid Ref. (12 digit, 6E,6N): 567789, 836491
Vent Details Diameter: 0.40m Height above Ground(m): 7.633m
Date of commencement of emission: 2004
Characteristics of Emission: Boiler rating 3000 kg/hr Steam Output: 2.145 MW Thermal Input: Boiler fuel Oil Fired Dennis Baldwin MX3000 Type: 5000 kg/hr Maximum rate at which fuel is burned Low sulphur fuel % sulphur content: NOx 239.4 mg/Nm 3 o 0 C. 3% O 2(Liquid or Gas), 6% O 2(Solid Fuel) Maximum volume* of emission 1370 m 3/hr o 0 C, 3 % O 2 (liquid or gas), 6 % O 2 (solid fuel) Minimum efflux velocity For inspection purposes only. o Consento of copyright owner required for any other use. o Temperature 250 C(max) 183 C(min) 167 C(avg)
* Volume flow limits for emissions to atmosphere shall be based on Normal conditions of temperature and pressure, (i.e. 0 oC,101.3kPa), dry gas; 3% oxygen for liquid and gas fuels; 6% oxygen for solid fuels.
(i) 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 60 min/hr 24 hr/day 365 day/yr (avg)
Page 114 of 235
EPA Export 29-05-2012:04:39:44
IPPC Application Form V2/12
TABLE E.1(ii) MAIN EMISSIONS TO ATMOSPHERE (1 Page for each emission point)
Emission Point Ref. N o: A2-1 (known as B-HVAC/HEPA Filtered Air in the current licence and AER reports)
Source of Emission: HVAC/HEPA Filtered Air
Location: Main Plant
Grid Ref. (12 digit, 6E,6N): 567777, 836543
Vent Details Diameter: 0.30m
Height above Ground(m): 3.75m Date of commencement: 1991
Characteristics of Emission:
(i) Volume to be emitted:
Average/day 568,858 Nm3/d Maximum/day 9,600,000 Nm 3/d
Maximum rate/hour 400,000 Nm 3/h Min efflux velocity 6.6 m.sec -1
(ii) Other factors For inspection purposes only. Consent of copyright owner required for any other use.
Temperature 27 oC(max) 12 oC(min) 25.57 oC(avg)
For Combustion Sources: Volume terms expressed as : wet. dry. ______%O 2
(iii) 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 60 min/hr 24 hr/day 365 day/yr (avg)
Page 115 of 235
EPA Export 29-05-2012:04:39:44
IPPC Application Form V2/12
TABLE E.1(iii): MAIN EMISSIONS TO ATMOSPHERE - Chemical characteristics of the emission (1 table per emission point)
Emission Point Reference Number: A2-1 (Referred to as B-HVAC/HEPA Filtered Air in the current licence and AER reports)
Parameter Prior to treatment (1) Brief As discharged (1) mg/Nm 3 kg/h description mg/Nm 3 kg/h. kg/year Avg Max Avg Max of treatment Avg Max Avg Max Avg Max Particulate Removal - - - - HEPA Filtration 0 0 0 0 0 0 Absence of - - - - HEPA Filtration 0 0 0 0 0 0 Production Biological Agents TA Luft Class III - - - - HEPA Filtration 8.80 25 0.21 10 1,827 87,600 Organics
For inspection purposes only. Consent of copyright owner required for any other use.
1. Concentrations should be based on Normal conditions of temperature and pressure, (i.e. 0 oC,101.3kPa). Wet/dry should be the same as given in Table E.1(ii) unless clearly stated otherwise.
Page 116 of 235
EPA Export 29-05-2012:04:39:44
IPPC Application Form V2/12
TABLE E.1(iv): EMISSIONS TO ATMOSPHERE - Minor atmospheric emissions
Emission point Description Emission details 1 Abatement system employed Reference Numbers material mg/Nm kg/h. kg/year 3(2) A3-1 Referred to as Emission Absence 0 0 0 HVAC / HEPA Filter Point A of Biological HVAC / HEPA Filtered Air Agents 0.86 0.012 107 TA Luft Filtered air from the Class III HEPA cleaning system Organics A3-2 Emission Point C Absence 0 0 0 HVAC / HEPA Filter HVAC / HEPA Filtered Air of Biological
Agents Filtered air from the 1.31 0.021 185 TA Luft HEPA cleaning system Class III Organics
A3-3 Emission Point S1 Absence For inspection purposes0 only. 0 0 HVAC / HEPA Filter Stellamune Extension Consentof of copyright owner required for any other use. Biological HVAC / HEPA Filtered Air Agents 3.15 0.018 156.1 TA Luft Filtered air from the Class III HEPA cleaning system Organics A3-4 Emission Point S2 Absence 0 0 0 HVAC / HEPA Filter Stellamune Extension of Biological HVAC / HEPA Filtered Air Agents 3.15 0.018 156.1 TA Luft Filtered air from the Class III
Page 117 of 235
EPA Export 29-05-2012:04:39:44
IPPC Application Form V2/12
HEPA cleaning system Organics
Note 1 A3-5 Domestic Boiler. Located SO 2 0.130 101.73 Low sulphur fuels, periodic preventative at the QC Building maintenance and best boiler-house SO 3 0.002 1.296 practice are used to minimise smoke NOx 0.046 35.640 effluent and to maximise efficiency of CO 0.004 3.240 combustion. PM 0.010 8.042 Note 1 A3-6 Domestic Boiler 1. SO 2 0.126 98.872 Low sulphur fuels, periodic preventative Located at the St. Colms maintenance and best boiler-house SO 3 0.002 1.259 Building. practice are used to minimise smoke NOx 0.044 34.637 effluent and to maximise efficiency of CO 0.004 3.149 combustion. PM 0.010 7.815 Note 1 A3-7 Domestic Boiler. Located SO 2 0.007 5.371 Low sulphur fuels, periodic preventative at the SSB Building. maintenance and best boiler-house SO3 0.000 0.068 practice are used to minimise smoke NOx 0.024 18.817 effluent and to maximise efficiency of CO 0.002 1.711 combustion. PM 0.002 1.416 Note 1 A3-8 Domestic Boiler 2. SO 2 0.126 98.872 Low sulphur fuels, periodic preventative Located at the St. Colms maintenance and best boiler-house SO 3 0.002 1.259 practice are used to minimise smoke NOx 0.044 34.637 effluent and to maximise efficiency of For inspection purposes only. Consent ofCO copyright owner required for any0.004 other use. 3.149 combustion. PM 0.010 7.815 A3-9 Exhaust from wash area Negligible Periodic preventative maintenance and best practice are used to maximise efficiency.
A3-10 Minor steam or Steam or Negligible Periodic preventative maintenance and condensate emission condensate best practice are used to maximise efficiency.
A3-11 Minor steam or Steam or Negligible Periodic preventative maintenance and
Page 118 of 235
EPA Export 29-05-2012:04:39:44
IPPC Application Form V2/12
condensate emission condensate best practice are used to maximise efficiency. A3-12 Minor steam or Steam or Negligible Periodic preventative maintenance and condensate emission condensate best practice are used to maximise efficiency. A3-13 Minor steam or Steam or Negligible Periodic preventative maintenance and condensate emission condensate best practice are used to maximise efficiency. A3-14 Bioreactor Filtered Negligible HEPA Filter Exhaust HEPA filters are a key emission control measure at the Elanco facility. They are subject to regular inspection, integrity testing and validation. The maintenance of the Air Handling Units, HVAC systems and HEPA filters are included in the preventative maintenance schedule. A3-15 Bioreactor Filtered Negligible HEPA Filter Exhaust HEPA filters are a key emission control measure at the Elanco facility. They are subject to regular inspection, integrity testing and validation. The maintenance of the Air Handling Units, HVAC systems For inspection purposes only. and HEPA filters are included in the Consent of copyright owner required for any other use. preventative maintenance schedule. A3-16 Minor steam or Steam or Negligible Periodic preventative maintenance and condensate emission condensate best practice are used to maximise efficiency. Negligible A3-17 Emergency Generator SO 2 The Emergency Generator will only be used for emergency situations and SO 3 testing to confirm availability. This NOx equipment will be fired on low sulphur CO fuel which will minimise emissions of PM SOx. A3-18 Compressor House Main Negligible Periodic preventative maintenance and
Page 119 of 235
EPA Export 29-05-2012:04:39:44
IPPC Application Form V2/12
Plant best practice are used to maximise efficiency. 19A3 -19 Recirculation Cabinet Negligible Periodic preventative maintenance and Exhaust. best practice are used to maximise efficiency.
1 The maximum emission should be stated for each material emitted, the concentration should be based on the maximum 30 minute mean. 2 Concentrations should be based on Normal conditions of temperature and pressure, (i.e. 0 oC101.3kPa). Wet/dry should be clearly stated. Include reference oxygen conditions for combustion sources.
Notes: Note 1 Domestic Boiler emissions (kg/year) have been estimated based on fuel consumption over a typical year (2010). Domestic Boiler emissions (kg/h) have been estimated based on 261 working days per year and based on 8 hours of use per day.
The monitoring undertaken for the IPPC licence for the facility shows that the HEPA filters are effective in preventing the emission of biological agents from the facility. On this basis is not considered that the proposed extension will result in any emissions of biological agents.
For inspection purposes only. Consent of copyright owner required for any other use.
Page 120 of 235
EPA Export 29-05-2012:04:39:44
IPPC Application Form V2/12
TABLE E.1(v): EMISSIONS TO ATMOSPHERE – Fugitive and Potential atmospheric emissions
Emission point ref. no. Description Malfunction which Emission details (as per flow diagram) could cause an (Potential max. emissions) 1 emission Material mg/Nm 3 kg/hour HEPA filters The rooms in the HEPA filter failure HEPA filters are a key emission control measure at the Elanco (potential atmospheric suite where the Rupture of the media facility. They are subject to regular inspection, integrity testing cultures are grown and validation. The maintenance of the Air Handling Units, HVAC emissions) Fire are at a negative systems and HEPA filters are included in the preventative pressure to Failure in gasket seal maintenance schedule. surrounding airlocks Pinhole leaks and the air leaving these areas is filtered through high efficiency particulate air (HEPA) filters. Processing and testing - - - - - activities do not generate aerosols No solvents are used in - - For inspection purposes only. - - - Consent of copyright owner required for any other use. the production process which could generate potential atmospheric emissions. No solids which could - - - - - generate potential atmospheric emissions are stored in the open.
1 Estimate the potential maximum emission for each malfunction identified.
Page 121 of 235
EPA Export 29-05-2012:04:39:44
IPPC Application Form V2/12
TABLE E.2(i): EMISSIONS TO SURFACE WATERS (One page for each emission)
Emission Point:
Emission Point Ref. N o: Not Applicable
Source of Emission:
Location of discharge :
Grid Ref. (12 digit, 6E,6N): Name of receiving waters and
water body code:
Flow rate in receiving waters: m3.sec -1 Dry Weather Flow m3.sec -1 95%ile flow
Available assimilative kg/day capacity:
Emission Details:
(i) Volume to be emitted
Normal/day m3 Maximum/day For inspection purposes only. m3 Consent of copyright owner required for any other use.
Maximum rate/hour m3
(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) min/hr hr/day day/yr
Page 122 of 235
EPA Export 29-05-2012:04:39:44
IPPC Application Form V2/12
TABLE E.2(ii): EMISSIONS TO SURFACE WATERS - Characteristics of the emission (1 table per emission point)
Emission point reference number: Not Applicable
Parameter Prior to treatment As discharged % Efficiency Max. Max. d aily kg/day kg/year Max. hourly Max. daily kg/day kg/year hourly average average (mg/l) average (mg/l) average (mg/l) (mg/l)
Not Applicable
For inspection purposes only. Consent of copyright owner required for any other use.
Page 123 of 235
EPA Export 29-05-2012:04:39:44
IPPC Application Form V2/12
TABLE E.3(i): EMISSIONS TO SEWER (One page for each emission)
Emission Point:
Emission Point Ref. N o: SE1 (Referred to as SW1 in the current licence and AER)
Location of connection to sewer: Main Plant See Application Form Drawing 4
Grid Ref. (12 digit, 6E,6N): 567801, 836499
Name of sewage undertaker: Sligo County Council
Emission Details:
(i) Volume to be emitted
Normal/day 3 m 3 Maximum/day 15 m 3
Maximum rate/hour 1.5 m 3
For inspection purposes only. (ii) Period or periods during which emissions are made,Consent of orcopyright are ownerto be required made, for any including other use. daily or seasonal variations ( start-up /shutdown
to be included):
Periods of Emission 60 min/hr 24 hr/day 365 day/yr (avg)
Page 124 of 235
EPA Export 29-05-2012:04:39:45
IPPC Application Form V2/12
TABLE E.3(ii): EMISSIONS TO SEWER - Characteristics of the emission (1 table per emission point)
Emission point reference number: SE1 (Referred to as SW1 in the current licence and AER)
Parameter Prior to treatment As discharged % Efficiency Max. Max. daily kg/day kg/year Max. hourly Max. daily kg/day kg/year hourly average average (mg/l) average (mg/l) average (mg/l) (mg/l)
C.O.D Not 227.98 227.98 29.3 7,635.4 227.98 227.98 29.3 7,635.4 applicable BOD Not 100.59 100.59 12.9 3,369.6 100.59 100.59 12.9 3,369.6 applicable Total Phosphorus (as P) Not 3.19 3.19 0.1 37.44 3.19 3.19 0.1 37.44 applicable Total Kjeldahl Nitrogen Not 4.97 4.97 0.6 166.14 4.97 4.97 0.6 166.14 applicable Total Ammonia (as N) Not 1.59 1.59 0.1 35.1 1.59 1.59 0.1 35.1 applicable For inspection purposes only. Formaldehyde Consent of copyright owner required for any other use. Not
3.34 3.34 0.4 112.32 3.34 3.34 0.4 112.32 applicable Suspended Solids Not 18.81 18.81 2.9 758.16 18.81 18.81 2.9 758.16 applicable pH 0 – 14 pH units 6 – 9 pH units 100% Mercury 0.015 0.015 0.0696 18.154 0.015 0.015 0.000087 0.0227 99.8% (isolation + capture at source estimated efficiency)
Page 125 of 235
EPA Export 29-05-2012:04:39:45
IPPC Application Form V2/12
Emission point reference number : SE2 (Known as SW2 in the current licence and AER)
Parameter Prior to treatment As discharged % Efficiency Max. Max. daily kg/day kg/year Max. hourly Max. daily kg/day kg/year hourly average average (mg/l) average (mg/l) average (mg/l) (mg/l)
C.O.D 200 200 3 1095 200 200 3 1095 Not applicable BOD 100 100 1.5 547.5 100 100 1.5 547.5 Not applicable Total Phosphorus (as P) 10 10 0.2 54.8 10 10 0.2 54.8 Not applicable Total Kjeldahl Nitrogen 15 15 0.3 82.1 15 15 0.3 82.1 Not applicable For inspection purposes only. Total Ammonia (as N) 10 10 0.2 Consent of54.8 copyright owner required10 for any other use. 10 0.2 54.8 Not applicable Suspended Solids 100 100 1.5 547.5 100 100 1.5 547.5 Not applicable pH 0 – 14 pH 5-10 pH 100%
Page 126 of 235
EPA Export 29-05-2012:04:39:45
IPPC Application Form V2/12
TABLE E.4(i): EMISSIONS TO GROUND (1 Page for each emission point)
Emission Point or Area: Emission Point/Area Ref. N o: Not Applicable
Emission Pathway: (borehole, well, percolation area, soakaway, landspreading, etc.) Location :
Grid Ref. (12 digit, 6E,6N):
Elevation of discharge: (relative to Ordnance Datum)
Aquifer classification for receiving groundwater body:
Groundwater vulnerability assessment (including vulnerability rating):
Identity and proximity of groundwater sources at risk (wells, springs, etc):
Identity and proximity of surface water bodies at risk:
Emission Details:
(i) Volume to be emitted
For inspection3 purposes only. 3 Normal/day Consent of copyrightm owner requiredMaximum/day for any other use. m
Maximum rate/hour m3
(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) min/hr hr/day day/yr
Page 127 of 235
EPA Export 29-05-2012:04:39:45
IPPC Application Form V2/12
TABLE E.4(ii): EMISSIONS TO GROUND - Characteristics of the emission (1 table per emission point)
Emission point/area reference number: Not Applicable
Parameter Prior to treatment As discharged % Efficiency Max. Max. daily kg/day kg/year Max. hourly Max. daily kg/day kg/year hourly average average (mg/l) average (mg/l) average (mg/l) (mg/l)
Not Applicable
For inspection purposes only. Consent of copyright owner required for any other use.
Page 128 of 235
EPA Export 29-05-2012:04:39:45
IPPC Application Form V2/12
Table E.5(i): NOISE EMISSIONS - Noise sources summary sheet
Source Emission Equipment Sound Octave bands (Hz) Impulsive Periods point Ref. No Pressure 1 Sound Pressure 1 Levels dB(unweighted) per band or tonal of Ref. No dBA at qualities Emission reference distance 31.5 63 125 250 500 1K 2K 4K 8K
Existing Noise Sources
Refrigeration N1 - 65.7dBA at 75- 69- 65- 62- 61 58- 54- 44- 34- No 24hr compressor 1m 77 75 66 64 59 55 46 35 unit Emergency N3 - As generator required
Chiller unit N4 - 84.7dBA at 76- 85- 75- 82- 81.5- 78- 78- 68- 58- No 24hr 1m 78 87 77 83 82.5 79 81 69 59 Boiler house N5 - 76.4dBA at 72- 66- 70- 74- 72-75 70 67- 62- 55 No 24hr 1m 76 73 76 78 68 64
HVAC Exhaust N6 - 83.1dBA at 74- 75- 74- 77- 81-83 76. 70- 61. 54. No 24hr (Main Plant) 1m 76 76 76 79 5- 71 5- 1- For inspection purposes only. 78 62 54. Consent of copyright owner required for any other use. 8
Air Compressor N7 - 71.2dBA at 79- 75- 67- 71- 72-73 72- 65- 62- 61- No 24hr (QC lab) 1m 80 77 68.5 72 73 66 65 62 HVAC Exhaust N8 - 58.7dBA at 70- 63- 63- 56- 58-59 53. 47- 37- 27- No 24hr (QC lab) 4m 77 65 64 58 9- 48. 38 29 55. 3 5 AHU N18 - The noise from this source was not audible over the No 24hr extraction units and refrigeration units in 2010. Freezer unit N19 During the 2010 Noise Measurement Survey the No 24hr noise meter was located adjacent to this unit (ML1). It was noted that the chiller unit was the dominant noise source in this location.
Page 129 of 235
EPA Export 29-05-2012:04:39:45
IPPC Application Form V2/12
Additional Noise Sources as a result of the Stellamune Extension
S1 N2 72 77 67 62 64 62 56 47 No 24hr Fermentation S1 Formulation N10 68 73 65 63 61 59 51 41 No 24hr S3 Fill Finish N11 72 79 71 66 62 61 57 50 No 24hr S4 Plantroom N12 58 61 58 42 43 50 40 30 No 24hr S5 Interstitial N13 54 55 55 41 41 46 38 30 No 24hr AHU N14 70 77 66 66 65 64 57 48 No 24hr AHU N15 70 77 66 66 65 64 57 48 No 24hr Chiller N16 92 102 101 95 93 87 82 77 No 24hr Condenser N17 78dBA at No 24hr 1m
1. For items of plant sound power levels may be used.
Note: Due to the fact that the noise sources are largely all internal or attenuated through screening, and that the predicted noise levels are likely to be imperceptible at the nearest sensitive receptors (Rathedmond Estate), it is considered that the noise sources will not introduce a tonal or impulsive noise source to the existing noise For inspection climate. purposes only. Consent of copyright owner required for any other use.
There are no noise sensitive locations in the immediate vicinity of the Elanco facility with the nearest residential estate located 0.22km to the south east (Rathedmond Estate).
The current IPPC licence requires that a noise survey of the site operations is undertaken every 3 years. The last noise measurement survey was undertaken in June 2010 by Elanco. Noise measurements were taken at 14 measurement locations. These measurement locations included measurements at the Main Plant, QC Building, St.Colms Building and at the Rathedmond Residential Estate (the nearest residential receptor).
Based on the levels recorded at the Elanco boundary positions in 2010, it was considered that the site was operating in compliance with the requirements of the EPA IPPC licence.
Page 130 of 235
EPA Export 29-05-2012:04:39:45
IPPC Application Form V2/12
TABLE F.1(i): ABATEMENT / TREATMENT CONTROL
Emission point reference number : A2-1 – B HVAC / HEPA Filtered Air
Control1 parameter Equipment 2 Equipment maintenance Equipment calibration Equipment back-up
Production Biological Agents HEPA Filter Equipment will be In accordance with Maintenance Supplies routinely inspected and manufacturers maintained in accordance instructions with manufacturers specifications
Currently TA Luft Class HVAC System / HEPA Equipment will be In accordance with Maintenance Supplies III Organics Filter routinely inspected and manufacturers (Isopropanol) maintained in accordance instructions (reclassified as Total Organic Carbon (as with manufacturers C) (Isopropanol) specifications
Particulate Matter HEPA Filter Equipment will be In accordance with Maintenance Supplies routinely inspected and manufacturers maintained in accordance instructions For inspection purposes only. Consentwith of copyrightmanufacturers owner required for any other use.
specifications
Control 1 parameter Monitoring to be carried out 3 Monitoring equipment Monitoring equipment calibration Absence of Production Monthly Laboratory In accordance with Biological Agents manufacturers specifications Particulate Removal Bi-annually or on re-validation Linear Photometer In accordance with manufacturers specifications
Page 131 of 235
EPA Export 29-05-2012:04:39:45
IPPC Application Form V2/12
Currently TA Luft Class III Quarterly Laboratory In accordance with Organics (Isopropanol) manufacturers specifications (reclassified as Total Organic Carbon (as C) (Isopropanol)
1 List the operating parameters of the treatment / abatement system which control its function. 2 List the equipment necessary for the proper function of the abatement / treatment system. 3 List the monitoring of the control parameter to be carried out.
For inspection purposes only. Consent of copyright owner required for any other use.
Page 132 of 235
EPA Export 29-05-2012:04:39:45
IPPC Application Form V2/12
Emission point reference number : A3-1 –A HVAC / HEPA Filtered Air
Control 1 parameter Equipment 2 Equipment maintenance Equipment calibration Equipment back-up Production Biological HEPA Filter Equipment will be In accordance with Maintenance Supplies Agents routinely inspected and manufacturers maintained in accordance instructions with manufacturers specifications Particulate Removal HEPA Filter Equipment will be In accordance with Maintenance Supplies routinely inspected and manufacturers maintained in accordance instructions with manufacturers specifications Currently TA Luft Class HVAC System / HEPA Equipment will be In accordance with Maintenance Supplies III Organics Filter routinely inspected and manufacturers (Isopropanol) (reclassified maintained in accordance instructions as Total Organic Carbon with manufacturers (as C) (Isopropanol) specifications
For inspection purposes only. Consent of copyright owner required for any other use.
Control 1 parameter Monitoring to be carried out 3 Monitoring equipment Monitoring equipment calibration Production Biological Agents Monthly Laboratory In accordance with manufacturers specifications Particulate Removal Bi-annually or on re-validation Linear Photometer In accordance with manufacturers specifications
Page 133 of 235
EPA Export 29-05-2012:04:39:45
IPPC Application Form V2/12
Currently TA Luft Class III Quarterly Laboratory In accordance with Organics manufacturers specifications (Isopropanol) (reclassified as Total Organic Carbon (as C) (Isopropanol)
1 List the operating parameters of the treatment / abatement system which control its function. 2 List the equipment necessary for the proper function of the abatement / treatment system. 3 List the monitoring of the control parameter to be carried out.
For inspection purposes only. Consent of copyright owner required for any other use.
Page 134 of 235
EPA Export 29-05-2012:04:39:45
IPPC Application Form V2/12
Emission point reference number : A3-2 – C HVAC / HEPA Filtered Air
Control 1 parameter Equipment 2 Equipment maintenance Equipment calibration Equipment back-up Production Biological HEPA Filter Equipment will be In accordance with Maintenance Supplies Agents routinely inspected and manufacturers maintained in accordance instructions with manufacturers specifications Particulate Removal HEPA Filter Equipment will be In accordance with Maintenance Supplies routinely inspected and manufacturers maintained in accordance instructions with manufacturers specifications Currently TA Luft Class HVAC System / HEPA Equipment will be In accordance with Maintenance Supplies III Organics Filter routinely inspected and manufacturers (Isopropanol) maintained in accordance instructions with manufacturers (reclassified as Total specifications Organic Carbon (as C) (Isopropanol)
For inspection purposes only. Consent of copyright owner required for any other use.
Control 1 parameter Monitoring to be carried out 3 Monitoring equipment Monitoring equipment calibration Production Biological Agents Monthly Laboratory In accordance with manufacturers specifications Particulate Removal Bi-annually or on re-validation Linear Photometer In accordance with manufacturers specifications
Page 135 of 235
EPA Export 29-05-2012:04:39:45
IPPC Application Form V2/12
Currently TA Luft Class III Quarterly Laboratory In accordance with Organics (Isopropanol) manufacturers specifications (reclassified as Total Organic Carbon (as C) (Isopropanol)
1 List the operating parameters of the treatment / abatement system which control its function. 2 List the equipment necessary for the proper function of the abatement / treatment system. 3 List the monitoring of the control parameter to be carried out.
For inspection purposes only. Consent of copyright owner required for any other use.
Page 136 of 235
EPA Export 29-05-2012:04:39:45
IPPC Application Form V2/12
Emission point reference number : A3-3 – S1 HVAC / HEPA Filtered Air
Control 1 parameter Equipment 2 Equipment maintenance Equipment calibration Equipment back-up Production Biological HEPA Filter Equipment will be In accordance with Maintenance Supplies Agents routinely inspected and manufacturers maintained in accordance instructions with manufacturers specifications Particulate Removal HEPA Filter Equipment will be In accordance with Maintenance Supplies routinely inspected and manufacturers maintained in accordance instructions with manufacturers specifications Total Organic Carbon (as HEPA Filter Equipment will be In accordance with Maintenance Supplies C) (Isopropanol) routinely inspected and manufacturers (reclassified as Total maintained in accordance instructions Organic Carbon (as C) with manufacturers (Isopropanol) specifications
For inspection purposes only. Consent of copyright owner required for any other use.
Control 1 parameter Monitoring to be carried out 3 Monitoring equipment Monitoring equipment calibration Production Biological Agents Monthly- To be determined with Laboratory In accordance with the Agency manufacturers specifications Particulate Removal Bi-annually or on re-validation - Linear Photometer In accordance with To be determined with the manufacturers specifications Agency
Page 137 of 235
EPA Export 29-05-2012:04:39:45
IPPC Application Form V2/12
Total Organic Carbon (as C) Quarterly - To be determined Laboratory In accordance with (Isopropanol) with the Agency manufacturers specifications (reclassified as Total Organic Carbon (as C) (Isopropanol)
1 List the operating parameters of the treatment / abatement system which control its function. 2 List the equipment necessary for the proper function of the abatement / treatment system. 3 List the monitoring of the control parameter to be carried out.
For inspection purposes only. Consent of copyright owner required for any other use.
Page 138 of 235
EPA Export 29-05-2012:04:39:45
IPPC Application Form V2/12
Emission point reference number : A3-4 – S2 HVAC / HEPA Filtered Air
Control 1 parameter Equipment 2 Equipment maintenance Equipment calibration Equipment back-up Production Biological HEPA Filter Equipment will be In accordance with Maintenance Supplies Agents routinely inspected and manufacturers maintained in accordance instructions with manufacturers specifications Particulate Removal HEPA Filter Equipment will be In accordance with Maintenance Supplies routinely inspected and manufacturers maintained in accordance instructions with manufacturers specifications Total Organic Carbon (as HEPA Filter Equipment will be In accordance with Maintenance Supplies C) (Isopropanol) routinely inspected and manufacturers (reclassified as Total maintained in accordance instructions Organic Carbon (as C) with manufacturers (Isopropanol) specifications
For inspection purposes only. Consent of copyright owner required for any other use.
Control 1 parameter Monitoring to be carried out 3 Monitoring equipment Monitoring equipment calibration Production Biological Agents Monthly - To be determined Laboratory In accordance with with the Agency manufacturers specifications Particulate Removal Bi-annually or on re-validation - Linear Photometer In accordance with To be determined with the manufacturers specifications Agency
Page 139 of 235
EPA Export 29-05-2012:04:39:45
IPPC Application Form V2/12
Total Organic Carbon (as C) Quarterly - To be determined Laboratory In accordance with (Isopropanol) with the Agency manufacturers specifications (reclassified as Total Organic Carbon (as C) (Isopropanol)
1 List the operating parameters of the treatment / abatement system which control its function. 2 List the equipment necessary for the proper function of the abatement / treatment system. 3 List the monitoring of the control parameter to be carried out.
For inspection purposes only. Consent of copyright owner required for any other use.
Page 140 of 235
EPA Export 29-05-2012:04:39:45
IPPC Application Form V2/12
Emission point reference number : SE1 (Known as SW1 in the AER and current licence) –Discharge from Main Plant
Control 1 parameter Equipment 2 Equipment maintenance Equipment calibration Equipment back-up pH pH correction system Equipment will be In accordance with Maintenance Supplies routinely inspected and manufacturers maintained in accordance instructions with manufacturers specifications Oil Oil Interceptor Equipment will be In accordance with Maintenance Supplies routinely inspected and manufacturers maintained in accordance instructions with manufacturers specifications Mercury Isolation and Capture at Equipment will be In accordance with Maintenance Supplies Source routinely inspected and manufacturers maintained in accordance instructions with manufacturers specifications
Control 1 parameter Monitoring to be carried out 3 Monitoring equipment Monitoring equipment For inspection purposes only. calibration Consent of copyright owner required for any other use.
Outlet flow Continuous On-line flowmeters with In accordance with recorder manufacturers specifications 24hr flow proportional In accordance with COD Weekly composite sampler manufacturers specifications Suspended Solids Weekly 24hr flow proportional In accordance with composite sampler manufacturers specifications Biochemical Oxygen Demand Monthly 24hr flow proportional In accordance with composite sampler manufacturers specifications Total Phosphorus Quarterly 24hr flow proportional In accordance with composite sampler manufacturers specifications
Page 141 of 235
EPA Export 29-05-2012:04:39:45
IPPC Application Form V2/12
Total Kjeldahl Nitrogen Quarterly 24hr flow proportional In accordance with composite sampler manufacturers specifications Total Ammonia Quarterly 24hr flow proportional In accordance with composite sampler manufacturers specifications Effluent Toxicity Currently annually 24hr flow proportional In accordance with composite sampler manufacturers specifications Future monitoring to be determined in consultation with the Agency In accordance with pH Continuous Calibrated pH probe and meter manufacturers specifications Temperature Thermometer In accordance with Weekly manufacturers specifications Mercury Monthly 24hr flow proportional In accordance with composite sampler - To be manufacturers specifications determined with the Agency
1 List the operating parameters of the treatment / abatement system which control its function. 2 List the equipment necessary for the proper function of the abatement / treatment system. 3 List the monitoring of the control parameter to be carried out.
For inspection purposes only. Consent of copyright owner required for any other use.
Page 142 of 235
EPA Export 29-05-2012:04:39:45
IPPC Application Form V2/12
Emission point reference number : SE2 (Known as SW2 in the AER and current licence) –Discharge from QC Laboratory
Control 1 parameter Equipment 2 Equipment maintenance Equipment calibration Equipment back-up pH pH monitoring system Equipment will be In accordance with Maintenance Supplies If the pH level is outside routinely inspected and manufacturers the limit value of the maintained in accordance instructions IPPC licence (5-10 pH with manufacturers units), the wastewater is specifications directed to the hazardous waste chemical stores, where it is temporarily stored before disposal via a licensed contractor. Oil Oil Interceptor Equipment will be In accordance with Maintenance Supplies routinely inspected and manufacturers maintained in accordance instructions with manufacturers specifications
For inspection purposes only. Consent of copyright owner required for any other use.
Control 1 parameter Monitoring to be carried out 3 Monitoring equipment Monitoring equipment calibration Outlet flow Continuous Chart Recorder In accordance with manufacturers specifications pH Continuous In accordance with Calibrated pH probe and meter manufacturers specifications Grab sample In accordance with COD Weekly manufacturers specifications
Page 143 of 235
EPA Export 29-05-2012:04:39:46
IPPC Application Form V2/12
Suspended Solids Weekly Grab sample In accordance with manufacturers specifications Biochemical Oxygen Demand Monthly Grab sample In accordance with manufacturers specifications Total Phosphorus Quarterly Grab sample In accordance with manufacturers specifications Total Kjeldahl Nitrogen Quarterly Grab sample In accordance with manufacturers specifications Total Ammonia Quarterly Grab sample In accordance with manufacturers specifications Effluent Toxicity Currently annually In accordance with manufacturers specifications Future monitoring to be Grab sample determined in consultation with the Agency Temperature Weekly Thermometer In accordance with manufacturers specifications
1 List the operating parameters of the treatment / abatement system which control its function. 2 List the equipment necessary for the proper function of the abatement / treatment system. 3 List the monitoring of the control parameter to be carried out.
Note on SE2 Sampling: It is noted that due to the intermittent nature of the flow from this emission point and to ensure compliance with the IPPC Licence conditions, it is proposed to undertake a design/technical For inspection purposes review only. during the summer of 2012, with regard to the volume and Consent of copyright owner required for any other use. quality of the discharge to the sewer. The recommendations of this review will be implemented on site to confirm that any discharges are managed appropriately and have minimum impact on the sewer.
Page 144 of 235
EPA Export 29-05-2012:04:39:46
IPPC Application Form V2/12
TABLE F.2(i) : EMISSIONS MONITORING AND SAMPLING POINTS ( 1 table per monitoring point)
Emission Point Reference No. : SE1 (Known as SW1 in the AER and current licence) –Discharge from Main Plant Parameter Monitoring frequency Accessibility of Sampling Sampling method Analysis method/ Points technique Outlet flow On-line flowmeters with On-line flowmeters with Continuous Safe and easily accessible recorder recorder COD 24hr flow proportional Weekly Safe and easily accessible Digestion / Colorimetric composite sampler Suspended Solids 24hr flow proportional Weekly Safe and easily accessible Gravimetric Method composite sampler Biochemical Oxygen 24hr flow proportional Standard Methods for Demand Monthly Safe and easily accessible composite sampler Water & Wastewater Analysis 1995 Total Phosphorus 24hr flow proportional Standard Methods for Quarterly Safe and easily accessible composite sampler Water & Wastewater Analysis 1995 Total Kjeldahl Nitrogen 24hr flow proportional Standard Methods for Quarterly Safe and easily accessible composite sampler Water & Wastewater Analysis 1995 Total Ammonia 24hr flow proportional Standard Methods for Quarterly ForSafe inspection and purposes easily only. accessible composite sampler Water & Wastewater Consent of copyright owner required for any other use. Analysis 1995 pH Calibrated pH probe and Calibrated pH probe and Continuous Safe and easily accessible meter meter Temperature Weekly Safe and easily accessible Thermometer Thermometer Mercury Monthly 24hr flow proportional Standard Methods for Water & Wastewater Safe and easily accessible composite sampler (to be determined with Agency) Analysis 1995 (to be determined with Agency) Note: Effluent Toxicity is currently monitored annually and is within compliance with the current IPPC Licence limits. Further monitoring to be agreed with the EPA.
Page 145 of 235
EPA Export 29-05-2012:04:39:46
IPPC Application Form V2/12
TABLE F.2(i) : EMISSIONS MONITORING AND SAMPLING POINTS ( 1 table per monitoring point)
Emission Point Reference No. : SE2 (Known as SW2 in the AER and current licence) –Discharge from Main Plant
Parameter Monitoring frequency Accessibility of Sampling Sampling method Analysis method/ Points technique On-line flowmeters with Outlet flow Continuous Safe and easily accessible Chart Recorder recorder COD Weekly Safe and easily accessible Grab sample Digestion / Colorimetric Suspended Solids Weekly Safe and easily accessible Grab sample Gravimetric Method Biochemical Oxygen Grab sample Standard Methods for Demand Monthly Safe and easily accessible Water & Wastewater Analysis 1995 Total Phosphorus Grab sample Standard Methods for Quarterly Safe and easily accessible Water & Wastewater Analysis 1995 Total Kjeldahl Nitrogen Grab sample Standard Methods for Quarterly Safe and easily accessible Water & Wastewater Analysis 1995 Total Ammonia Grab sample Standard Methods for For inspection purposes only. Quarterly Consent of Safecopyright and owner easily required for accessible any other use. Water & Wastewater Analysis 1995 pH Calibrated pH probe and Continuous Safe and easily accessible Chart Recorder meter Temperature Weekly Safe and easily accessible Thermometer Thermometer
Note: Effluent Toxicity is currently monitored annually and is within compliance with the current IPPC Licence limits. Further monitoring to be agreed with the EPA.
Page 146 of 235
EPA Export 29-05-2012:04:39:46
IPPC Application Form V2/12
TABLE F.2(ii): AMBIENT ENVIRONMENT MONITORING AND SAMPLING POINTS ( 1 table per monitoring point)
Monitoring Point Reference No : ML1-ML15
Parameter Monitoring frequency Accessibility of Sampling method Analysis method / Sampling point technique
Noise Every 3 years Good access, monitoring Noise Meter Noise survey locations on premises or from public roadways.
For inspection purposes only. Consent of copyright owner required for any other use.
Page 147 of 235
EPA Export 29-05-2012:04:39:46
IPPC Application Form V2/12
Table G.1(i) Details of Process related Raw Materials, Intermediates, Products, etc., used or generated on the site
An excel file of this information has been included on CD with this application for ease of review.
Ref. Material/ CAS Danger (2) Amount Annual Nature of Use R(3) - S(3) - Hazard No or Substance (1) Number Category Stored Usage Phrase Phrase Statement (4) Code (tonnes) (tonnes) Manufacturing 100FD00 01 Drakeol-6VR 8042-47-5 Xi 500ml 450ml Manufacturing N.A N/A 100FD00 Sodium hydrogen 03 carbonate 144-55-8 N/A 0.003 0.019281 Manufacturing N/A N/A 100FD00 04 Emusligen SA N/A N/A 25 L 122.504 L Manufacturing N/A N/A 100FD00 Eagles Hepes(Minimum 05 Essential N/A N/A 0.008 0.0481 Manufacturing N/A N/A 100FD00 07 Trytose phosphate broth 7558-79-4 Xi 0.00005 0.00005 Manufacturing 36/37/38 7-22-26-36 100FD00 08 Eagles Earles MEM N/A N/A 0.02 0.116772 Manufacturing N/A N/A 100FD00 13 Glucose monohydrate 14431-43-7 Xi, Xn 0.004 0.022984 Manufacturing N/A N/A For inspection purposes only. Consent of copyright owner required for any other use. H31, H334, 100FD00 P261, P280, 16 Neomycin sulphate 1405-10-3 Xi, Sensitizer 0.000728 0.000728 Manufacturing 42/43 22-36/37-45 P342, P311 100FD00 17 Gentamycin sulphate 1405-41-0 N/A 0.000225 0.000225 Manufacturing Xi, Hazardous N/A H315, H319, H335, P261, 100FD00 2 Bromoethylamine Xi, mutagenic, P305, P351, 18 hydrobromide 2576-47-8 sensitizer, N 0.0003 0.00195 Manufacturing 36/37/39 26-36/37 P338 H314, H335, P261, P280, 100FD00 P305, P351, 19 Hydrochloric acid 7647-01-0 T 1.5m L 7.88 L Manufacturing N/A N/A P338, P310 100FD00 Thiamine Hydrochloride 67-03-8 Xi 0.00015 0.00015 Manufacturing N/A N/A
Page 148 of 235
EPA Export 29-05-2012:04:39:46
IPPC Application Form V2/12
20 100FD00 Sodium thiosulphate 21 pentahydrate 10102-17-7 Xi 0.0015 0.00832 Manufacturing N/A N/A 100FD00 Disodium hydrogen 23 phosphate 7782-85-6 Xi 0.002 0.010437 Manufacturing N/A N/A 100FD00 25 Sorbitan monostearae 1338-41-6 Xi 0.00009 0.000009 Manufacturing N/A 24/25 100FD00 Tween 80 ( Polysorbate 26 80) 1338-41-6 Xi 2 L 10.5 L Manufacturing N/A N/A 100FD00 21/22- 27 Sodium dodecyl sulphate 151-21-3 Xi, F+ 0.00035 0.000348 Manufacturing 36/37/38 26-36/37 100FD00 Sodium hydrogen Xi, mutagenic, 20-22-36-37- 28 sulphite 7631-90-5 sensitizer, N 0.003 0.0176 Manufacturing 38 26-36 100FD00 29 Pyruvic acid sodium salt 113-24-6 N/A 0.000005 0.000005 Manufacturing N/A N/A 100FD00 Magnesium chloride 0.0000000 0.00000001 30 hexahydrate 7791-18-6 Xi 5 5 Manufacturing N/A N/A 100FD00 31 Glycerol 56-81-5 Xi 1ml 0.0826ml Manufacturing N/A N/A H302, H315, 100FD00 Iron II sulphate H319, P305, 32 heptahydrate 7782-63-0 Xi, Xn 0.001 0.004988 Manufacturing 22-36-37-38 26-36-37-39 P351, P338 100FD00 Calcium chloride 34 dehydrate 10035-04-8 F, Xi 0.0009 0.004775 Manufacturing 36/37/38 22-24/25-26 H225, H315, H317, H319, H335, P210, P261, P280, 100FD00 P305, P351, For inspection purposes only. 35 EMA 31 97-63-2 Xi, Xn Consent 0.0003 of copyright 0.001496owner required for Manufactur any other use. ing 10-36-37-38 N/A P338 100FD00 Zinc sulphate 22-26-39-46- 36 heptahydrate 7446-20-0 Xi, Xn, N 0.001 0.004989 Manufacturing 22-41-50/53 60-61 100FD00 37 Cyancobalamin (Vit B12) 68-19-9 N/A 0.000002 0.000002 Manufacturing N/A N/A H314, P280, 100FD00 P305, P351, 38 Sodium hydroxide 1310-73-2 Xn, C 0.006 0.036475 Manufacturing 35 26-37/39-45 P338, P310 100FD00 Collagen Coated 39 Microcarrier 24936-41-2 N/A 0.004 0.023921 Manufacturing N/A N/A H315, H319, H335, P261, 100FD00 P305, P351, 40 Phenol red 143-74-8 Xi 0.000004 0.000004 Manufacturing N/A N/A P338
Page 149 of 235
EPA Export 29-05-2012:04:39:46
IPPC Application Form V2/12
100FD00 Potassium hydrogen 41 phosphate 11/4/7758 Xi 0.004 0.024553 Manufacturing N/A N/A 100FD00 42 Potassium chloride 7747-40-7 N/A 0.000493 0.000493 Manufacturing N/A N/A 100FD00 43 Sucrose 57-50-1 N/A 0.02 0.089813 Manufacturing N/A N/A H319, H302, 100FD00 0.0000002 P305, P351, 44 Ammonium Chloride 12125-02-9 Xn, C 6 0.00000026 Manufacturing 34 N/A P338 H314, P280, 100FD00 P305, P351, 46 Butyric acid 107-92-6 Xi, C 50ml 17.6ml Manufacturing 34 26-36-45 P338, P310 100FD00 47 Sodium chloride 7647-14-5 Xi 0.02 0.092629 Manufacturing N/A N/A H314, H302, P280, P305, 100FD00 26-36/37/39- P351, P338, 48 Potassium hydroxide 1310-58-3 C, Xn 0.000231 0.000231 Manufacturing 22-35 45 P310 100FD00 Potassium dihydrogen 51 phosphate 7778-77-0 Xi 0.0003 0.001442 Manufacturing N/A N/A 100FD00 EDTA acid disodium salt H319, P305, 52 dihydrate 6381-92-6 T, Xi, Xn 0.0002 0.0002 Manufacturing 36/37/38 26-36/37/39 P351, P338 100FD00 54 Bacto peptone N/A N/A 0.003 0.014597 Manufacturing N/A N/A 100FD00 57 Gelatine 9000-70-8 Xi 0.002 0.008 Manufacturing N/A N/A 100FD00 Disodium tetraborate H360, P201, 58 decahydrate 1303-96-4 N/A 0.000022 0.000022 Manufacturing N/A N/A P308, P313 100FD00 For inspection purposes only. 64 Bovine serum albumin 9048-46-8 Sensitizer, Xi Consent 0.002 of copyright 0.007503owner required for Manufacturing any other use. N/A N/A 100FD00 68458-87-7 65 Lactalbumin hydrolysate Xi 0.005 0.025087 Manufacturing N/A N/A H319, H315, H334, H335, P261, P305, 100FD00 22-24-26- P351, P338, 66 Porcine trypsin 7/7/9002 Xi, Sensitizer 0.0008 0.003586 Manufacturing 36/37/38-42 36/37 P342, P311 H373, H330, H310, H410, P260, P264, P273, P280, 100FD00 P284, P302, 67 Thimerosal 54-64-8 T+, Sensitizer 0.00065 0.00065 Manufacturing 26/27/28-33 2-13-28-36-45 P350
Page 150 of 235
EPA Export 29-05-2012:04:39:46
IPPC Application Form V2/12
H319, H335, 100FD00 P261, P305, 68 Saponin Powder N/A N/A 0.004 0.022848 Manufacturing N/A N/A P351, P338 H302, H315, 100FD00 22-38-40- H351, H373, 70 Antifoam C Emulsion 67-66-3 Xn 0 0 Manufacturing 48/20/22 36/37 P281 100FD00 71 Neocryl XK-62 N/A C, Xi 70 L 421.79 L Manufacturing 34-52/53 N/A 100FD00 - 72 Rehydragel LV 21645-51-2 N/A 21 L 125 L Manufacturing N/A N/A 100FD00 H302 73 Polybrene 28728-55-4 N/A 0.000153 0.000153 Manufacturing N/A N/A 100FD00 74 Sorbitol instant 50-70-4 N/A 0.00006 0.00006 Manufacturing N/A N/A 100FD01 16 NZ Amine NS N/A N/A 0.015 0.061424 Manufacturing N/A N/A 100FD01 Sodium acetate 17 trihydrate 6131-90-4 Xi 0.0008 0.0048 Manufacturing N/A 24/25 100FD01 Trisodium phosphate 18 dodecahydrate 10101-89-0 Xi 0.003 0.017238 Manufacturing 36/38 N/A 100FD01 Aliminium chloride 19 hexhydrate 7784-13-6 C 0.001 0.00495 Manufacturing 34 1/2-7/8-28-45 100FD01 22 Albumax 1 N/A Xi 0.0003 0.0015 Manufacturing N/A N/A H315, H319, H335, P261, 100FD01 24/25-28A-37- P305, P351, 32 Natural Squalane 111-01-3 Xi 100ml 40ml Manufacturing N/A 45 P338 100FD01 Pluronic L-121 For inspection purposes only. 33 Surfactant 11/6/9003 N/A Consent 0.5 ofL copyright 0.408owner required L for Manufacturin any other use. g N/A N/A 100FD01 11-23/24/25- 26-36/37/39- H302, H317, 35 Formalin N/A T, F+, Sensitizer 7 L 40 L Manufacturing 39/23/24/25 45-51 H351, P280 100FD01 41 Trypticase soy broth 7647-14-5 Xi 0.007 0.04041 Manufacturing 36/37/38 7-22-26-36 H351, H410, P273, P280, 100FD01 22-40-41- 26-36/37/39- P305, P351, 42 Crystal violet 548-62-9 T, Xn, N 0.000018 0.000018 Manufacturing 50/53 46-60-61 P338, P501 20-21-22-36- 100FD01 37-38-40-45- 44 Trypan blue stain 72-57-1 Xn, carcinogenic 0.000005 0.000005 Manufacturing 47 45 100FD01 59 Hepes acid 7365-45-9 Xi 0.001 0.003741 Manufacturing N/A N/A
Page 151 of 235
EPA Export 29-05-2012:04:39:46
IPPC Application Form V2/12
100FD01 Optimem 50x Salts 1 60 solution N/A Xi 20 L 112.4 L Manufacturing N/A N/A 100FD01 Optimex 50x Acid 61 soluble solution 7647-01-0 T, C, Xi 12 L 69.9 L Manufacturing N/A N/A 100FD01 Optimem50x Salts II 62 solution 7647-14-5 Xi 12.5 L 72.75 L Manufacturing N/A N/A 100FD01 Sodium dihydrogen 81 phosphate dehydrate 13472-35-0 Xi 0.000508 0.000508 Manufacturing N/A N/A 100FD01 83 Lactose 63-42-3 Xi 0.004 0.02185 Manufacturing N/A N/A 100FD02 Vitamin A Acetate 13 (powder) 127-47-9 Xi 0.0000001 0.0000001 Manufacturing N/A N/A 100FD02 0.0000000 15 d-Biotin 58-85-5 Xi 5 0.00000005 Manufacturing N/A N/A 100FD02 Fetal Bovine Serum 25 Irradiated N/A N/A 30 L 163.35 L Manufacturing N/A N/A 100FD02 Possibly 30 NeoCryl A-640 7732-18-5 carcinogenic 25 L 145.17 L Manufacturing N/A N/A 100FD02 DBS EMEA Compliant 32 500ml N/A N/A 50 L 296.9 L Manufacturing N/A N/A 100FD02 36 Carbopol 1/4/9003 Xi 0.0000065 0.0000065 Manufacturing N/A N/A 100FD02 45 Phytosqualene 111-01-3 Xi 100ml 40ml Manufacturing 36/37/38 26-36 100FD02 49 Ethanol 64-17-5 Xi, F+ 1.5 L 7.5 L Manufacturing 11 7/8/2016 H225, P210 100FD02 Disodium phosphate 50 dodecahydrate N/A N/A 0.000102 0.000102 Manufacturing N/A N/A 100FD02 For inspection purposes only. 51 Tylosin tartrate 1405-54-5 Xi Consent 0.00006 of copyright 0.00006owner required for Ma anynufacturing other use. N/A N/A 100FD02 55 MEM glasgow N/A N/A 0.0000142 0.0000142 Manufacturing N/A N/A 200FD02 44 Buffer 4 N/A N/A 5.5 L 33 L Manufacturing N/A N/A 200FD02 45 Buffer 10 1330-43-4 N/A 6 L 36 L Manufacturing N/A N/A 200FD02 46 Buffer 7 N/A N/A 5.5 L 33 L Manufacturing N/A N/A 200FD04 37 Buffer 6 N/A N/A 1 L 5 L Manufacturing N/A N/A 200FD04 38 Buffer 8 1330-43-4 N/A 1 L 3.5 L Manufacturing N/A N/A 500FD00 Decon Neutracon 5ltrs N/A 30 L 160 L Manufacturing 36/38 24/25/26
Page 152 of 235
EPA Export 29-05-2012:04:39:46
IPPC Application Form V2/12
06 500FD00 09 Stainless steel polish N/A Xn, C, Xi, Sensitizer 4 L 20 L Manufacturing 20-21-22-34 N/A 1310-73-2 500FD00 DETERGENT NEODISHER & 5064-31- 26/27/28, 29 Z 3 Xi, C 6 L 35 L Manufacturing 35/36/41 36/37/38, 45 500FD00 26-36/37/39- 32 Sodium Hypochlorite 7681-52-9 C 85 L 487.5 Manufacturing 34 45 500FD00 11-38-50/53- 37 Sigmacote N/A F+, Xn, N, C 0.5 L 0.5 L Manufacturing 65-67-34 60-61-62 23/24/25-34- 500FD00 39/23/24/25- 26-36/37/39- H302, H317, 39 Formalin 50-00-0 T, F, C, Sensitizer 15 L 80 L Manufacturing 40-43 45-51 H351, P280 1310-73-2 500FD00 & 5064-31- 26/27/28, 42 Neodisher alka 240 3 Xi, C 8 L 48 L Manufacturing 35/36/41 36/37/38, 45 H225, H319, H336, P210, 500FD00 P261, P305, 43 Isopropyl alcohol 67-63-0 Xi, Xn, F+ 340 L 2021 L Manufacturing 36-11 N/A P351, P338 500FD00 General purpose 55 degreaser 603 N/A N/A 15 L 85 L Manufacturing N/A N/A H302, H318, 500FD00 P280, P305, 59 Hydrogen peroxide 7722-84-1 Xn 30 L 136.8 L Manufacturing 22-41 26-39 P351, P338 H302, H314, H318, H400, 500-FD- H315, H319, 046 Klericide 68391-01-5 Xi 15 L 65 L Manufacturing N/A N/A H317, H11 For inspection purposes only. None Buffer 13 1310-73-2 Xi Consent 1 L of copyright 4owner L required for Manufacturing any other use. 36/38 26-37-60 100FD02 67 Bovine Calf Serum - - 0.00045 0.0027 Manufacturing - - S36/37, 46, 51, None Yet Antifoam Solution 50% Xn 0.0035 0.019958 Manufacturing R53, R62 61 Phosphate Buffer None Yet Solution - 3.5L 20L Manufacturing - - None Yet Porcine Serum - 0.0019 0.0019 Manufacturing - - S-2, S-22, S- R-22, R- 24, S-26, S- 36/37/38, R- 36/37, S-38, S- Powder HAL MEM media - Xi 0.001065 0.001065 Manufacturing 42, R-61 45 New Chromium(III)Chloride For new product - request hexahydrate Xn Annual usage not Manufacturing R22 - H302
Page 153 of 235
EPA Export 29-05-2012:04:39:46
IPPC Application Form V2/12
(M=266.45) available yet Conjugate: peroxidase For new product - New conjugated goat anti Annual usage not R26/27/28, 33, request guinea pig IgG T+, N available yet Manufacturing 50/53 - For new product - New Annual usage not request Guinea pig complement - available yet Manufacturing - - For new product - New Negative guinea pig Annual usage not request serum - available yet Manufacturing - - For new product - New Annual usage not request Sheep blood in alsever - available yet Manufacturing - - For new product - New Annual usage not request Skimmilk - available yet Manufacturing - - H300, H311, H330, P260, For new product - P264, P280, New Annual usage not P284, P301, request Tetanus Toxin T+ available yet Manufacturing R26/27/28 S28, 36/37, 45 P310 For new product - New Veronal buffer (5x Annual usage not request concentrated) - available yet Manufacturing - - For new product - H314, P280, Annual usage not R26, 36/37/39, P305, P351, None Aluminium phosphate C available yet Manufacturing R34 45 P338, P310 For new product - Annual usage not None Yet Dextrose Solution - Foravailable inspection purposesyet only. Manufacturing - - Consent of copyright owner required for any other use. For new product - Annual usage not None Yet Drakeol 5 F available yet Manufacturing - - For new product - Annual usage not None Yet Sorbitan Monooleate Xi available yet Manufacturing - - For new product - Annual usage not None Yet USP Water - available yet Manufacturing - - For new product - Annual usage not None Yet Yeast Extract Solution - available yet Manufacturing - - None Yet PPLO Broth Xi For new product - Manufacturing R 36 / 37 / 38, S7, S 22, S
Page 154 of 235
EPA Export 29-05-2012:04:39:46
IPPC Application Form V2/12
Annual usage not 24/25/26, S 36 available yet For new product - Annual usage not DMEM w/o L glut Xi available yet Manufacturing - - For new product - Pancreatic Digest of Annual usage not Casein - available yet Manufacturing - - Liquid Nitrogen N2 - 10,000L 41,600 L Manufacturing - - H314, H361, New Product - For new product - New Product - P280, P305, MSDS not available Annual usage not R10 R21/22 MSDS not P351, P338, Alchem 1102 108-91-8 yet available yet Manufacturing R34 available yet P310 New Product - For new product - New Product - New Product - MSDS not available Annual usage not MSDS not MSDS not Ester Oil Type 023E yet available yet Manufacturing available yet available yet New Product - For new product - New Product - New Product - MSDS not available Annual usage not MSDS not MSDS not Ester Oil Type 048E yet available yet Manufacturing available yet available yet New Product - For new product - New Product - New Product - MSDS not available Annual usage not MSDS not MSDS not Ester Oil Type York V yet available yet Manufacturing available yet available yet New Product - For new product - New Product - New Product - L2 Freeze Drying MSDS not available Annual usage not MSDS not MSDS not Stabilizer yet available yet Manufacturing available yet available yet New Product - For new product - New Product - New Product - New Indubiose agar MSDS not available Annual usage not MSDS not MSDS not request A37(agarose) yet available yet Manufacturing available yet available yet New Product - For new product - New Product - New Product - MSDS not available Annual For inspection usage purposes not only. MSDS not MSDS not Consent of copyright owner required for any other use. None Yet Amphigen Base yet available yet Manufacturing available yet available yet New Product - For new product - New Product - New Product - MSDS not available Annual usage not MSDS not MSDS not None Yet Polysorbate 30 yet available yet Manufacturing available yet available yet New Product - For new product - New Product - New Product - MSDS not available Annual usage not MSDS not MSDS not None Yet Quest 412 yet available yet Manufacturing available yet available yet H225, H319, H336, P210, 500FD00 P261, P305, 43 Isopropyl alcohol 67-63-0 Xi, Xn, F+ Detailed previously Filling 36-11 N/A P351, P338 500FD00 26-36/37/39- 32 Sodium Hypochlorite 7681-52-9 Corrosive Detailed previously Filling 34 45
Page 155 of 235
EPA Export 29-05-2012:04:39:46
IPPC Application Form V2/12
H302, H318, 500FD00 P280, P305, 59 Hydrogen peroxide 7722-84-1 Xn Detailed previously Filling 22-41 26-39 P351, P338 200FD02 44 Buffer 4 N/A N/A Detailed previously Filling N/A N/A 200FD02 45 Buffer 10 1330-43-4 N/A Detailed previously Filling N/A N/A 200FD02 46 Buffer 7 N/A N/A Detailed previously Filling N/A N/A 2, 23, 24, 35, 64742-48-9 Ordered as required, for 51, 62, 6, WD 40 124-38-9 F, Xn equipment maintenance Finishing R66 R10 R65 3/9/14
Quality Control H225, H319, H336, P210, 500FD00 P261, P305, 43 Isopropyl alcohol 67-63-0 Xi, F+, Xn Detailed previously QC 36-11 N/A P351, P338 300FD00 49 Ethanol 64-17-5 Xi, F+ 5 L 10 L QC 11 7/8/2010 H 225, P210 H225, H301, H311, H331, H370, P210, P260, P280, 300FD02 T, Xi, Xn, 11-23/24/25- P301, P310, 35 Methanol 67-56-1 mutagen,F 2.5L 2.6L QC 39 N/A P311 H314, H226, P280, P305, 200FD02 P351, P338, 47 Acetic Acid 64-19-7 F, C, Xn 0.5 L For inspection 1.04L purposes only. QC 35-10 23-26-45 P310 Consent of copyright owner required for any other use. H226, H302, H318, H335, H336, P261, 300FD01 10-22-37/38- 7/9-13-26- P280, P305, 71 Butanol 71-36-3 Xi, Xn, F 1L 0.0001 L QC 41-67 37/39-46 P351, P338 H225, H319, H336, P210, 300FD00 P261, P305, 36 Acetone 67-64-1 Xi, F 2.5L 13L QC 11-36-37-67 9/16/2026 P351, P338 100FD00 11-21/22- 27 Sodium Laurylsulfate 151-21-3 F, Xi, Xn, sensitizer 0.000026 0.000026 QC 36/37/38 26-36/37 300FD00 45-28-34- H350, H410, 82 Arsenic III Oxide 1327-53-3 T+, N, Carcinogenic 0.0000052 0.0000052 QC 50/53 53-45-60-61 P201, P264,
Page 156 of 235
EPA Export 29-05-2012:04:39:46
IPPC Application Form V2/12
P273, P280, P305, P351, P338, P310 H314, H272, H301, H312, H317, H334, H340, H350, H410, H362Fd, P201, 45-46-60-61-8- P220, P261, 21-25-26-34- P273, P280, 300FD00 T+, O, N, Xn, 42/43-48/23- P305, P351, 56 Potassium dichromate 7778-50-9 Sensitizer, C 0.0000052 0.0000052 QC 50/53 53-45-60-61 P338 H373, H330, H300, H310, H410, P260, P264, P273, 300FD00 P280, P284, 77 Mercuric Iodine Red 7774-29-0 T+, Xi, teratogen 0.0000052 0.0000052 QC N/A N/A P301, P310 300FD00 63 Silver Nitrate 7761-88-8 T+, Xn, C 0.0000052 0.0000052 QC 34-50/53 26-45-60/61 Alkaline Potassium N/A Tetraiodomercurate N/A T+, Xi, C, mutagen 0.2 L 1.56L QC N/A N/A 300FD02 18 Carboxylmethyl cellulose 9004-32-4 T, Xi, Xn 0.00016 0.00016 QC N/A N/A 300FD02 36 Tween 20 9005-64-5 T, Xi, Harmful 1 L 1L QC N/A N/A Freshly Prepared Solution For inspection purposes only. Consent of copyright owner required for any other use. Blocking reagent( not held in N/A QCSMPS082 N/A T, C, Xi stock 15L QC N/A 100FD00 EDTA acid disodium salt 0.0000010 H319, P305, 52 dihydrate 6381-92-6 T, Xi, Xn 4 0.00000104 QC 36/37/38 26-36/37/39 P351, P338 H314, P280, 500FD00 T, Xi, C, P305, P351, 23 Dilute sulphuric acid 7664-93-9 Carcinogenic 2.5L 2.6L QC 35 26-30-45 P338, P310 H301, H315, H317, H331, H334, H341, H350I, H360, 300FD01 Nickel II Chloride 45-25-36/38- 53-36/37-45- H372, H410, 85 Hexhydrate 7791-20-0 T, N Carcinogenic 0.0000052 0.0000052 QC 43-50/53 60-61 P201, P261,
Page 157 of 235
EPA Export 29-05-2012:04:39:46
IPPC Application Form V2/12
P273, P280, P301, P310, P311 H302, H311, H330, H400, P260, P273, 300FD00 23/24/25-33- 28-36/37-45- P280, P284, 65 Diphenylamine Soln 122-39-4 T, Sensitizer 0.0000052 0.0000052 QC 50/53 60-61 P310 100FD00 Zinc Sulfate 22-26-39-46- 36 Heptahydrate 7446-20-0 T, Xi, Xn, N 0.0000004 0.0000004 QC 22-41-50/53 60-61 20/21-25- H317, H341, 300FD02 36/37/38-40- 26-28-36/37- H351, H411, 96 O-Phenylenediamine 615-28-1 T, N 0.0000004 0.0000004 QC 43-50/53-68 45-60-61 P273, P280 300FD00 57 Potassium iodine 7681-11-0 T, Xi, Xn 0.0000004 0.0000004 QC N/A N/A H315, H319, H335, P261, 300FD00 P305, P351, 87 Potassium bromide 2/3/7758 T, Xi, Xn 0.0000004 0.0000004 QC 36/37/38 26-36 P338 100FD00 Sodium Sulfite 36 Anhydrous 7757-83-7 T, Xi, Xn 0.0000004 0.0000004 QC N/A N/A 300FD00 H301, H332, 78 Barium Chloride 10326-27-9 T, Xi, Xn 0.0000004 0.0000004 QC 20-25 45 P301, P310 300FD01 30 Sodium Nitroprusside 14402-89-2 T, Xi, Xn 0.0000004 0.0000004 QC 25 45 300FD01 H301, P301, 83 Methyl Orange 547-58-0 T, Mutagen, Xn, Xi 0.0000004 0.0000004 QC 25 45 P310 300FD02 1-(2-Pyridtlazo)-2- 94 Naphthol 85-85-8 T, Xi, Xn 0.0000004 0.0000004 QC 45 53-45 For inspection purposes only. 1,10 Phenanthroline Consent of copyright owner required for any other use. H301, H410, 300FD03 Monohydrochloride P272, P301, 10 Monohydrate 3829-86-5 T, Xi, Xn,N 0.0000002 0.0000002 QC 25-50/53 45-60-61 P310 H360, H373, H410, P201, 300FD00 61-8-20/22-33- P273, P308, 51 Lead 10099-74-8 T, Xn, O, N 0.0000002 0.0000002 QC 62-50/53 53-45-60-61 P313, P501 300FD00 86 Potassium Bromate 1/2/7758 T, O 0.0000004 0.0000004 QC 45/9/25 45/53 Carbon dioxide free No stock N/A water 124-38-9 Mildly T, C held 5 L QC N/A N/A 20-21-22-36- 300FD00 37-38-40-45- 75 Trypan blue stain 72-57-1 Xn, carcinogenic 0.1 L 0.052 QC 47 45
Page 158 of 235
EPA Export 29-05-2012:04:39:46
IPPC Application Form V2/12
O, Xn, 300FD01 Cobalt II nitrate-6 N Carcinogenic, 22-40-43- 17-36/37-60- 28 Hydrate 10026-22-9 Sensitiser, Irritant 0.0000004 0.0000004 QC 50/53 61 300FD00 Sodium Sulfite 66 Anhydrous 7757-83-7 Xn, Xi, mutagen 0.0000004 0.0000004 QC N/A N/A H302, H315, 300FD03 Ferrous Sulfate H319, P305, 09 Heptahydrate 7782-63-0 Xi, Xn, mutagen 0.0000004 0.0000004 QC N/A N/A P351, P338 100FD02 28 Dimethyl Sulfoxide 67-68-5 Xi, Xn, teratogen 0.05 L 0.012 L QC N/A N/A 300FD00 Sodium Hexanitrocobalt 8-36/37/38- 62 (III) 13600-98-1 Xi, Sensitizer, O, Xn 0.0000004 0.0000004 QC 42/43 17-26-36/37 300FD02 25 Potassium Nitrate 7757-79-1 Xi, Xn, O 0.0000004 0.0000004 QC 8 N/A H272, P220 H272, H302, H315, H319,H335, P220, P261, 300FD03 Ammonium Cerium (IV) P305, P351, 11 Nitrate 16774-21-3 Xi,O 0.0000004 0.0000004 QC 8-36/37/38 17-26-36 P338 H272, H302, 300FD00 Potassium H410, P220, 58 permanganate 7722-64-7 Xn, O, N 0.0000014 0.0000014 QC 8-22-50/53 60-61 P273, P501 300FD00 TMB MW Peroxide 51 Substrate System 6812-2 Oxidiser 1.8 L 7.8 L QC N/A N/A 300FD00 62 Sodium Cobaltnitrite 13600-98-1 Xi, Xn, Sensitizer 0.0000004 0.0000004 QC N/A N/A H319, H315, For inspection purposes only. H334, H335, Consent of copyright owner required for any other use. P261, P305, 100FD00 22-24-26- P351, P338, 66 Porcine trypsin 7/7/9002 Xi, Sensitizer 0.000006 0.000006 QC 36/37/38-42 36/37 P342, P311 100FD00 64 BSA 9048-46-8 Xi, Xn, sensitizer 0.000015 0.000015 QC N/A N/A H302, H315, H319, H410, P273, P305, 300FD00 Copper (II) Sulphate 22-36/38- P351, P338, 12 Pentahydrate 7758-99-8 Xi, Xn, N 0.0000004 0.0000004 QC 50/53 22-60-61 P501 300FD01 68 Sulfamic Acid 5329-14-6 Xi, Xn, N 0.0000004 0.0000004 QC 36/38-52/53 26-28-61 300FD01 Copper sulphate 7758-98-7 Xn, Xi, N 0.0000004 0.0000004 QC 22-36/38- 22-60-61 H302, H315,
Page 159 of 235
EPA Export 29-05-2012:04:39:46
IPPC Application Form V2/12
77 50/53 H319, H410, P273, P305, P351, P338, P501 300FD01 H302, H312, 49 Ammonium oxalate 6009-70-7 Xi, Xn 0.0000004 0.0000004 QC 21/22 24/25 P280 100FD00 H319, P305, 34 Calcium chloride 10043-52-4 Xi, Xn 0.0000004 0.0000004 QC 36 22-24 P351, P338 H315, H319, H335, P261, 300FD02 P305, P351, 91 Chromotropic Acid 5808-22-0 Xi, Xn 0.0000004 0.0000004 QC 36/37/38 26-36 P338 100FD00 13 Glucose monohydrate 14431-43-7 Xi, Xn 0.000012 0.000012 QC N/A N/A H302, H315, 300FD00 H351, H373, 70 Chloroform 67-66-3 Xn, Xi 0.5 L 0.06 L QC N/A N/ A P281 300FD00 90 Potassium Ferrocyanide 14459-95-1 Xn, Xi 0.0000004 0.0000004 QC N/A N/A H302, H315, H319, H335, 300FD01 P261, P305, 50 Potassium Carbonate 584-08-7 Xi, Xn 0.0000004 0.0000004 QC 22-36/37/38 22-36 P351, P338 300FD01 Potassium H302, H332, 87 Pyronoantimonate 12208-13-8 Xi, Xn 0.0000004 0.0000004 QC N/A N/A H411, P273 100FD00 31 Glycerol 56-81-5 Xi, Xn 2.5 L 10 L QC N/A N/A H302, H315, H319, H335, 300FD01 For inspection purposes only. P261, P305, Consent of copyright owner required for any other use. 36 Ninhydrin 485-47-2 Xi, Xn 0.0000004 0.0000004 QC 22-36/37/38 26 P351, P338 H272, H315, H319, H335, 9220, 9261, 300FD01 Lanthanum Nitrate P305, P351, 31 Hexahydrate 10277-43-7 Xi, Xn 0.0000004 0.0000004 QC N/A N/A P338 300FD02 Potassium Phosphate 05 monobasic 7778-77-0 Xi, Xn 0.0000004 0.0000004 QC N/A N/A H315, H319, H335, P261, 300FD01 P305, P351, 75 Ammonium Acetate 631-61-8 Xi. Xn 0.0000004 0.0000004 QC N/A N/A P338 300FD00 Iso-Propyl Myristate 110-27-0 Xi. Xn 0.1 L 0.024 L QC N/A N/A
Page 160 of 235
EPA Export 29-05-2012:04:39:46
IPPC Application Form V2/12
94 300FD02 10 Mycoplasma agar N/A Xi. Xn 3 L 20 L QC N/A N/A 300FD02 17 PEG 6000 25322-68-3 Xi. Xn 0.002 0.001 QC N/A N/A H315, H319, H335, P261, 300FD03 P305, P351, 07 Calconcarboxylic Acid 3737-95-9 Xi. Xn 0.0000004 0.0000004 QC 36/37/38 26-36 P338 300FD01 17 Starch 9005-25-8 Xi, Xn 0.0000004 0.0000004 QC N/A N/A H272, H315, H319, H335, P220, P261P 300FD01 Potassium (Meta) P305, P351, 88 Periodate 7790-21-8 Xi, Xn 0.0000004 0.0000004 QC 8-36-37-38 17-26-36 P338 H290, H302, H315, H318, 300FD00 Ferric Chloride P280, P305, 18 Anhydrous 7705-08-0 Xi, Xn 0.0000004 0.0000004 QC N/A N/A P351, P338 H302, H315, 300FD00 20-22-38-40- H351, H373, 75 Trichloromethane 67-66-3 Xi, Xn 0.5 L 0.020 L QC 48 36-37 P281 300FD03 Xylenol Orange 03 Tetrasodium Salt 3618-43-7 Xi, Xn 0.0000004 0.0000004 QC N/A N/A 300FD01 46 Sodium carbonate 497-19-8 Xi, Xn 0.0000004 0.0000004 QC 36 22-26 300FD02 Sodium phosphate 98 dibasic 7558-79-4 Xi, Xn 0.0000004 0.0000004 QC N/A N/A For inspection purposes only. Consent of copyright owner required for any other use. H319, H302, 100FD00 P305, P351, 44 Ammonium Chloride 12125-02-9 Xn, Xi 0.0000004 0.0000004 QC N/A N/A P338 300FD02 51 Pyrocatechol 115-41-3 Xi, Xn 0.0000004 0.0000004 QC N/A N/A 300FD00 90 Potassium Ferricyanide 13746-66-2 Xi, Xn 0.0000004 0.0000004 QC N/A N/A 300FD02 Potassium dihydrogen 05 phosphate 7778-77-0 Xi 0.0000004 0.0000004 QC N/A N/A 300FD02 Sodium dihydrogen 48 phosphate dehydrate 13472-35-0 Xi 0.0000004 0.0000004 QC N/A N/A 100FD00 52 Sodium Edetate 6381-92-6 Xi 0.0000004 0.0000004 QC 36/37/38 26-36/37/39 100FD00 Sodium Bicarbonate 144-55-8 Xi 0.0000004 0.0000004 QC N/A N/A
Page 161 of 235
EPA Export 29-05-2012:04:39:46
IPPC Application Form V2/12
03 300FD00 72 Magnesium sulphate 10034-99-8 Xi 0.0000004 0.0000004 QC N/A N/A 100FD00 47 Sodium chloride 7647-14-5 Xi 0.0000004 0.0000004 QC N/A N/A 300FD01 Disodium hydrogen 23 phosphate 7782-85-6 Xi 0.0000004 0.0000004 QC N/A N/A 300FD02 64 Sodium thiosulphate 7772-98-7 Xi 1 L 2.6 L QC N/A N/A 100FD00 Sodium phosphate 23 dibasic 7558-79-4 Xi 0.0000004 0.0000004 QC N/A N/A 300FD02 43 Tris 77-86-1 Xi 0.0000004 0.0000004 QC 36/37/38 26-36 H312, H332, 300FD03 H412, P273, 22 Potassium Thiocyanate 333-20-0 Xn 0.0000004 0.0000004 QC N/A N/A P280, EUH032 300FD03 22-24-25-36- 24 Methylene Chloride 75-02-9 Xn 0.0000004 0.0000004 QC 20-22-40 37 Monthly Prepared Wash solution (0.3% Solution Tween PBS) (QCSMPS not held in N/A 081) N/A N/A stock 180 L QC N/A N/A 300FD00 Mordent Black II 81 Triturate 1787-61-7 N/A 0.0000002 0.0000002 QC N/A N/A 300FD00 67 Bromothyomol Blue Soln 76-59-5 N/A 0.0000004 0.0000004 QC N/A N/A 200FD02 44 Buffer 4 N/A N/A 0.5 L 6 L QC N/A N/A For inspection purposes only. 200FD02 Consent of copyright owner required for any other use. 45 Buffer 10 1330-43-4 N/A 0.5 L 6 L QC N/A N/A 200FD02 46 Buffer 7 N/A N/A 0.5 L 6 L QC N/A N/A R20/21, 22, 23, 300FD02 34, 36, 38, 50, H360D, P201, 63 Hydranal Composite T, Xi, Xn, C 0.0001 0.0001 QC 61 S45, 53 P308, P313 H315, H319, H335, P261, 30FD026 P305, P351, 8 ABTS Substrate Xi 600ml 600ml QC R36/37/38 S26, 36 P338 H314, P280, 300FD00 P305, P351, 09 Sulphuric Acid C 3L 16.78L QC R35 24, 30, 45 P338, P310
Page 162 of 235
EPA Export 29-05-2012:04:39:47
IPPC Application Form V2/12
300FD00 97 Calcium Carbonate - 0.0000219 0.0000219 QC - - Engineering Services 10-11-12- 20/21-36-38- 2-16-23-25-26- N/A SWA galvanising spray N/A F+, Xi, Xn 0.5 L 1 L Eng 12-66-50/53 29-36/37-51 Surtest smoke detector 74-98-6, N/A tester 106-97-8 F+, Xn 0.5 L 1 L Eng 20 N/A N/A Tangit detergent cleaner 64-17-5 F+, Xi, Xn 1 L 4 L Eng 11 2-7/9-16-46/51 Foster spraytack 67-64-1, N/A adhesive aerosol 92062-15-2 F+, Xi, Xn, N 0.05 L 0.05 L Eng 12 23-51-38-16-2 N/A Falcon pvc solvent mix No msds F+, Xi 0.05 L 0.05 L Eng N/A N/A RS PVC solvent weld N/A adhesive No msds F+, Xi 0.05 L 0.05 L Eng N/A N/A 68476-85- 7, 92045- 11-38-36- 53-9, 67- 51/53-66-65- N/A Anti-seize spray 64-1 Xn, Xi, F+ 0.05 L 0.05 L Eng 67 16-23-51-35 H225, H319, H336, P210, 500FD00 P261, P305, 43 Isopropyl alcohol 67-63-0 Xi, Xn, F+ Detailed previously Eng 36-11 N/A P351, P338 H314, H226, Acetic P280, P305, 200FD02 Acid/phenopathein P351, P338, 47 indicator 64-19-7 F, C, Xn 0.150 L 0.065 L Eng 35-10 23-26-45 P310 65-36/38-10- Xn, Xi, N, F, 38-43-50/53- N/A Label remover N/A Sensitizer 0.5 L 1 L Eng 65-66 24-37-51 For inspection purposes only. Durapipes solvent Consent of copyright owner required for any other use. 9-16-24/25-26- N/A cement N/A Xi, F Eng 11-36-66-67 46-51 N/A Bicast acrylic resin N/A Xi, F, Sensitizer 0.5 L 1 L Eng N/A N/A 1332-77-0, 7789-29-9, 10043-35- 3, 1303- 86-2, 20/22-36/38- 2-13-20/21-22- N/A Thessco flux powder 14075-53-7 T, C, Xn 0.05 L 0.05 L Eng 34 23-26-45 N/A Sulphite tablets 7757-83-7 T, Xi. Xn 0.000065 0.000065 Eng N/A N/A Ammonium vanadomoly 34-25- 26-45-24/25- N/A bdate Mixture T, Corrosive, O, Xi 0.05 L 0.05 L Eng 36/37/38-8-35 36/37/39-50 36/37/38- 45-26-24- N/A TH5 hardness indicator Mixture T, Xi, Xn, C 0.5 L 2 L Eng 40/20/21/22- 36/37/39-61
Page 163 of 235
EPA Export 29-05-2012:04:39:47
IPPC Application Form V2/12
42/43 N/A Spectrus OX1271 13590-97-1 Xi, C, Sensitizer N/A N/A Eng N/A N/A 6317-18-6 H225, H319, H336, P210,
P261, P305, 67-63-0 P351, P338 H314, P280, 100FD00 Detailed P305, P351, 38 Sodium hydroxide 1310-73-2 Xn, C N/A previously Eng 35 26-37/39-45 P338, P310 H226, H302, H312, H314, H361, H332, 108-91-8+ P280, P305, 110-91- P351, P338, 8+100-37- P310 N/A Na 104C 8 C, Sensitizer 20 L 100 L Eng N/A N/A N/A Chem-aqua 900 9647-01-0 C, Xi 75 L 450 L Eng N/A N/A 1310-73- 295 & N/A BP-800 7732-18-5 C 20 L 100 L Eng N/A N/A 500FD00 26-36/37/39- 32 Sodium Hypochlorite 7681-52-9 Corrosive Detailed previously Eng 34 45 24/25- N/A Sulphite test titran N/A Xn, Sensitizer, Xi 0.150 L 0.065 L Eng 22-23 36/37/39-45 TH2 total hardness N/A buffer N/A Xi, Xn 0.150 L 0.065 L Eng 20-36/37/38 26-Feb 300FD02 64 Sodium thiosulphate 7772-98-7 Xi Detailed previously Eng N/A N/A For inspection purposes only. Rocol anti-seize Consent of copyright owner required for any other use. N/A compound N/A Xi 0.5 L 0.5 L Eng N/A N/A N/A Shell ondina oil 917 8042-47-5 Xi 1 L 5 L Eng N/A N/A 25852-47- 5, 18268- 70-7, 68611-44- 9, 81-07-2, N/A Loctite 243 threadlocker 114-83-0 Xi 0.2 L 0.2 L Eng N/A N/A 22-36-38-42- N/A RS electronic resin flux No msds Xi 0.2 L 0.2 L Eng 43 23-34-37 Rocol anti-seize 7440-50-8, N/A compound 7440-44-0 Xi Detailed previously Eng N/A N/A N/A Rocol foodlube spray 000124-38- Xi 1 L 1 L Eng N/A N/A
Page 164 of 235
EPA Export 29-05-2012:04:39:47
IPPC Application Form V2/12
9 N/A Silicone sealant N/A Xi 10 L 100 L Eng N/A N/A N/A Total 33 C N/A Xi 1 L 5 L Eng N/A N/A 7681-57-4 + 7757-83- N/A Chem-aqua 130 7 Xi 40 L 200 L Eng N/A N/A N/A Microbicide WT 8030-30-6 Xi 30 L 60 L Eng N/A N/A Alcatel 102 Mechanical N/A vaccum pump oil 64741-88-4 Mildly Xi 4 L 20 L Eng N/A N/A H302, H318, 500FD00 P280, P305, 59 Hydrogen peroxide 7722-84-1 Xn Detailed previously Eng 22-41 26-39 P351, P338 200FD02 44 Buffer 4 N/A N/A 0.5 L 2 L Eng N/A N/A 200FD02 45 Buffer 10 1330-43-4 N/A 0.5 L 2 L Eng N/A N/A N/A Conductivity standard Mixture N/A 0.150 L 0.065 L Eng N/A N/A 7681-52-9 H319, P305, 9003-04-7 26-36/37/39- P351, P338 NA Biochem 1004 28519-02-0 Xi 0.05 0.2 Engineering R31 R34 R36 45 R22 R31 7631-90-5 Xi, mutagenic, R36/37 R49 NA Oxychem 102 10124-43-3 sensitizer, N 0.05 0.425 Engineering R42/43 R50/53 26-36 68915-31-1 H319, P305, NA Polychem B302 9003-04-7 Xn 0.025 0.05 Engineering R36 R38 S26 P351, P338 2809-21-4 001310-58- 3 1312-76- 1 139-13-9 For inspection purposes only. 7320-34-5 Consent of copyright owner required for any other use. R34 R22 R35 S26, S27, NA Polychem C1033EV` 95-14-7 C Not used in 2011 Engineering R36/38 R37 S37/39 102 Mechanical vacuum Ordered as required, for H350, P201, pump oil - equipment maintenance Engineering - - P308, P313 Ordered as required, for SAE-90W - equipment maintenance Engineering - - Bioservices H225, H319, H336, P210, 500FD00 P261, P305, 43 Isopropyl alcohol 67-63-0 Xi, Xn, F+ Detailed previously Bioservices 36-11 N/A P351, P338 20/21/22- 500FD00 36/37/38-40- 22-26-37/39- 52 Roclean 3 50-00-0 F 0 0 Bioservices 43 45-51
Page 165 of 235
EPA Export 29-05-2012:04:39:47
IPPC Application Form V2/12
H225, H319, H336, P210, 500FD00 P261, P305, 36 Acetone 67-64-1 T, F, Xi, Xn 1 L 5 L Bioservices 11-36-66-67 9/16/2026 P351, P338 500FD00 26-36/37/39- 32 Sodium Hypochlorite 7681-52-9 Corrosive Detailed previously Bioservices 34 45 No specific 500FD00 CAS 26-27-28- 42 Neodisher Alka 240 number Xi, C 8 L 48 L Bioservices 35-36-41 36/37/39-45 500FD00 Neutrailising agent, H319, P305, 29 neodisher z 77-92-9 Xi 0.035 0.035 Bioservices 36 26-46 P351, P338 500FD00 General purpose 55 degreaser 603 N/A N/A Detailed previously Bioservices N/A N/A 200FD02 44 Buffer 4 N/A N/A Detailed previously Bioservices N/A N/A 200FD02 45 Buffer 10 1330-43-4 N/A Detailed previously Bioservices N/A N/A 200FD02 46 Buffer 7 N/A N/A Detailed previously Bioservices N/A N/A 500FD00 1310-58-3 S26-36/37/39- 57 CIP 100 64-02-8 C, Xn 0.005 0.009 Bioservices R35 R22 45 Thiomersal 54-64-8 T+, 0.0005 0.0005 Preservative 26/27/28-33 2-13-28-36-45 Intermediates Stored on site ANTIGEN - Antigens are utilised in the manufacturing process and are kept within the closed system. AEQUIS FELINE CALIZI 20626 AFCV VIRUS Doses Manufacturing AEQUIS FELINE 22980 AFPV PANLEUKOPENIA Doses Manufacturing AEQUIS FELINE 23848 For inspection purposes only. AFVR RHINOTRACHEITIS ConsentDoses of copyright owner required for Manufacturing any other use. 199666 BB Bordetella Brochiseptica Doses Manufacturing BRSV(OP BOVINE RESPIRATORY 336658 ) SYNCYTICAL Doses Manufacturing BOVINE VIRUS 335052 BVD(OP) DIARRHOEA ANTIGEN Doses Manufacturing EQUINE ARTERITIS 16158 EAVK VIRUS ANT STK Doses Manufacturing EQUINE INFLUENZA 298900 EIVK VIRUS ANTIGEN Doses Manufacturing EQUINE INFLUENZA 298900 EIVL VIRUS ANTIGEN Doses Manufacturing EIVP EQUINE INFLUENZA 298900 Manufacturing
Page 166 of 235
EPA Export 29-05-2012:04:39:47
IPPC Application Form V2/12
VIRUS ANTIGEN Doses FELINE CHLAMYDIA 187284 FCP 5UM PSITTACI Doses Manufacturing FCP FELINE CHLAMYDIA 1381758 75UM PSITTARI Doses Manufacturing FELINE CALICI VIRUS 2020340 FCV ANTIGEN Doses Manufacturing FELINE LEUKEMIA VIRUS 1187504 FELV ANT STK Doses Manufacturing FELINE PANLEUKOPENIA 1796978 FPV VIRUS Doses Manufacturing FELINE VIRUS 1963262 FVR RHINOTRACHEITIS Doses Manufacturing 334804 IBR(OP) INFECTIOUS BOVINE Doses Manufacturing PARAINFLUENZA VIRUS 334740 PI3(OP) TYPE 3 Doses Manufacturing EQUINE ROTAVIRUS 16536 ROTA ANTIGEN Doses Manufacturing 800FD00 18600 27 Antigen - Tetanus Toxoid Doses Manufacturing 800FD00 CAV2 Antigen Stock 1176796 44 (Roller Bt) Doses Manufacturing 800FD00 CPV Antigen Stock 423140 45 (Bioreactor) Doses Manufacturing 800FD00 Leptospira Canicola 642664 77 (OMC) Doses Manufacturing 800FD00 Leptospira 2088104 78 Icterohaemomhapiae Doses Manufacturing For inspection purposes only. 800FD00 Consent507942 of copyright owner required for any other use. 85 CCV CONCENTRATED Doses Manufacturing 800FD01 66346 33 FELV 100X Released Doses Manufacturing 800FD01 CDV (ond) Antigen Stk 53054 42 Biorctor Doses Manufacturing 800FD01 CPI Antigen Stock 2245388 73 (Bioreactor) Doses Manufacturing 800FD01 501891 90 West Nile Viral Antigen Doses Manufacturing 800FD02 31985 00 FVR Antigen Doses Manufacturing 800FD02 502516 01 FCV-255 Antigen Doses Manufacturing
Page 167 of 235
EPA Export 29-05-2012:04:39:47
IPPC Application Form V2/12
800FD02 503333 02 FCV-DD 1 Antigen Doses Manufacturing 800FD02 502500 03 FPV Antigen Doses Manufacturing Media The media is presented followed by the materials/substances used to create the media. 001SM LEPTOSPIRA MEDIUM 1X (Annual Usage 128 L) 100FD00 64 Bovine serum albumin 9048-46-8 Sensitizer, Xi 0.00001 0.00001 Manufacturing N/A N/A 100FD00 H319, P305, 34 Calcium chloride 10043-52-4 Xi, Xn 0.0000004 0.0000004 QC 36 22-24 P351, P338 100FD00 Magnesium chloride 0.0000000 0.00000001 30 hexahydrate 7791-18-6 Xi 15 5 Manufacturing N/A N/A 100FD00 Zinc Sulfate 22-26-39-46- 36 Heptahydrate 7446-20-0 T, Xi, Xn, N 0.0000004 0.0000004 QC 22-41-50/53 60-61 H302, H315, 100FD00 Iron II sulphate 0.0000000 H319, P305, 32 heptahydrate 7782-63-0 Xi, Xn 5 0.00000005 Manufacturing 22-36-37-38 26-36-37-39 P351, P338 100FD00 0.0000000 0.00000000 37 Cyancobalamin (Vit B12) 68-19-9 N/A 002 02 Manufacturing N/A N/A 100FD00 Tween 80 ( Polysorbate 26 80) 1338-41-6 Xi 5ml 1.26ml Manufacturing N/A N/A 100FD00 47 Sodium chloride 7647-14-5 Xi 0.0000004 0.0000004 QC N/A N/A H319, H302, 100FD00 0.0000002 P305, P351, 44 Ammonium Chloride 12125-02-9 Xn, C 6 0.00000026 Manufacturing 34 N/A P338 100FD00 0.0000000 0.00000000 20 Thiamine Hydrochloride 67-03-8 Xi 05 5 Manufacturing N/A N/A For inspection purposes only. 100FD00 Consent of copyright owner required for any other use. 29 Pyruvic acid sodium salt 113-24-6 N/A 0.0000001 0.0000001 Manufacturing N/A N/A 100FD00 31 Glycerol 56-81-5 Xi, Xn 2.5 L 10 L QC N/A N/A 100FD00 Sodium phosphate 23 dibasic 7558-79-4 Xi 0.0000004 0.0000004 QC N/A N/A 100FD00 Potassium dihydrogen 51 phosphate 7778-77-0 Xi 0.002 0.002 Manufacturing N/A N/A 002SM Eagles Earles 0.05% LAH Medium (Annual Usage 18914 L) 100FD00 0.0000096 08 Eagles Earles MEM N/A N/A 1 0.00000961 Manufacturing N/A N/A 100FD00 68458-87-7 65 Lactalbumin hydrolysate Xi 0.0000005 0.0000005 Manufacturing N/A N/A 100FD00 Sodium hydrogen 144-55-8 N/A 0.0000058 0.0000058 Manufacturing N/A N/A
Page 168 of 235
EPA Export 29-05-2012:04:39:47
IPPC Application Form V2/12
03 carbonate 003SM POLYMYXIN B SOLUTION (Annual Usage 9.4 L) 100FD00 14 Polymixin B Sulphate B 1405-20-5 Xn Manufacturing R22 N/A 004SM NEOMYCIN SOLUTION (Annual Usage 7.52 L) H317, H334, 100FD00 P261, P280, 16 Neomycin sulphate 1405-10-3 Xi, Sensitizer 0.000728 0.000728 Manufacturing 42/43 22-36/37-45 P342, P311 005SM GENTAMYCIN (Annual Usage 8.58 L) H317, H334, 100FD00 P261, P280, 17 Gentamycin sulphate 1405-41-0 N/A 0.000225 0.000225 Manufacturing Xi, Hazardous N/A P342, P311 006SM TRYPSIN VERSENE (Annual Usage 167.6 L) 100FD00 47 Sodium chloride 7647-14-5 Xi 0.0000004 0.0000004 QC N/A N/A 100FD00 42 Potassium chloride 7747-40-7 N/A 0.000004 0.000004 Manufacturing N/A N/A 100FD00 13 Glucose monohydrate 14431-43-7 Xi, Xn 0.000012 0.000012 QC N/A N/A 100FD00 03 Sodium Bicarbonate 144-55-8 Xi 0.0000004 0.0000004 QC N/A N/A H319, H315, H334, H335, P261, P305, 100FD00 22-24-26- P351, P338, 66 Porcine trypsin 7/7/9002 Xi, Sensitizer 0.000005 0.000005 Manufacturing 36/37/38-42 36/37 P342, P311 100FD00 H319, P305, 52 EDTA Acid Disodium Salt 6381-92-6 T, Xi, Xn 0.0002 0.0002 Manufacturing 36/37/38 26-36/37/39 P351, P338 007SM Bovine Albumin Solution (Annual Usage 103 L) For inspection purposes only. 100FD00 Consent of copyright owner required for any other use. 64 Bovine serum albumin 9048-46-8 Sensitizer, Xi 0.00001 0.00001 Manufacturing N/A N/A 008SM Tryptose Phosphate Medium 100FD00 07 Trytose phosphate broth 7558-79-4 Xi 0.0000295 0.0000295 Manufacturing 36/37/38 7-22-26-36 009SM Sodium Butyrate Solution H314, P280, 100FD00 P305, P351, 46 Butyric acid 107-92-6 Xi, C 50ml 17.6ml Manufacturing 34 26-36-45 P338, P310 010SM Sodium Bicarbonate Solution 100FD00 Sodium hydrogen 03 carbonate 144-55-8 N/A 0.0000058 0.0000058 Manufacturing N/A N/A 011SM LACTALBUMIN HYDROLYSATE 5% (Annual Usage 268 L) 100FD00 Lactalbumin hydrolysate 68458-87-7 Xi 0.0000005 0.0000005 Manufacturing N/A N/A
Page 169 of 235
EPA Export 29-05-2012:04:39:47
IPPC Application Form V2/12
65 013SM Glutamine Solution 100FD00 15 L Glutamine 56-85-9 N/A Manufacturing N/A N/ A 014SM EAGLES HEPES (0.05% LAH) (Annual Usage 4494 L) 100FD00 5 Eagles Hepes MEM N/A N/A Manufacturing N/A N/ A 100FD00 68458-87-7 65 Lactalbumin hydrolysate Xi 0.0000005 0.0000005 Manufacturing N/A N/A 100FD00 Sodium hydrogen 03 carbonate 144-55-8 N/A 0.0000058 0.0000058 Manufacturing N/A N/A 015M GELATIN (10%) SGGK-2 (Annual Usage 158 L) 100FD00 57 Gelatine 9000-70-8 Xi 0.0001 0.0001 Manufacturing N/A N/A 016SM SGGK-3 SOLUTION 1 (Annual Usage 396 L) 100FD00 54 Bacto peptone N/A N/A 0.00006 0.00006 Manufacturing N/A N/A 100FD00 43 Sucrose 57-50-1 N/A 0.00025 0.00025 Manufacturing N/A N/A 100FD00 Potassium hydrogen 41 phosphate 11/4/7758 Xi 0.0000042 0.0000042 Manufacturing N/A N/A 100FD00 Potassium dihydrogen 51 phosphate 7778-77-0 Xi 0.0000003 0.0000003 Manufacturing N/A N/A H314, H302, P280, P305, 100FD00 0.0000009 0.00000091 26-36/37/39- P351, P338, 48 Potassium hydroxide 1310-58-3 C, Xn 134 34 Manufacturing 22-35 45 P310 018SM Phospate Buffer Saline Solution (Annual Usage 668 L) 100FD00 For inspection purposes only. 47 Sodium chloride 7647-14-5 Xi Consent 0.00008 of copyright 0.00008owner required for Man any otherufacturing use. N/A N/A 100FD00 42 Potassium chloride 7747-40-7 N/A 0.000004 0.000004 Manufacturing N/A N/A 100FD00 Sodium phosphate 23 dibasic 7558-79-4 Xi 0.0000004 0.0000004 QC N/A N/A 100FD00 Potassium dihydrogen 51 phosphate 7778-77-0 Xi 0.002 0.002 Manufacturing N/A N/A 019SM Thimerosal (Annual Usage 8.2 L) H373, H330, H310, H410, P260, P264, P273, P280, 100FD00 P284, P302, 67 Thimerosal 54-64-8 T+, Sensitizer 0.0015 0.0015 Manufacturing 26/27/28-33 2-13-28-36-45 P350
Page 170 of 235
EPA Export 29-05-2012:04:39:47
IPPC Application Form V2/12
100FD00 Disodium tetraborate 0.0000044 0.00000442 H360, P201, 58 decahydrate 1303-96-4 N/A 29 9 Manufacturing N/A N/A P308, P313 020SM TRYPAN BLUE VITAL STAIN (Annual Usage 2.41 L) 20-21-22-36- 100FD01 37-38-40-45- 44 Trypan blue stain 72-57-1 Xn, carcinogenic 0.000005 0.000005 Manufacturing 47 45 022SM Sodium Hydroxide (1M) (Annual Usage 201 L) H314, P280, 100FD00 P305, P351, 38 Sodium hydroxide 1310-73-2 Xn, C 0.00004 0.00004 Manufacturing 35 26-37/39-45 P338, P310 023SM Phenol Red H315, H319, H335, P261, 100FD00 P305, P351, 40 Phenol red 143-74-8 Xi 0.000004 0.000004 Manufacturing N/A N/A P338 024SM Hydrochloric Acid (1M) (Annual Usage 246 L) H314, H335, P261, P280, 100FD00 P305, P351, 19 Hydrochloric acid 7647-01-0 T 150ml 82.89ml Manufacturing N/A N/A P338, P310 027SM Sodium Hydroxide (5M) (Annual Usage 322 L) H314, P280, 100FD00 P305, P351, 38 Sodium hydroxide 1310-73-2 Xn, C 0.00004 0.00004 Manufacturing 35 26-37/39-45 P338, P310 029SM BEI solution A (Annual Usage 24 L) H315, H319, H335, P261, 100FD00 2 Bromoethylamine Xi, mutagenic, 0.0000409 P305, P351, 18 hydrobromide 2576-47-8 sensitizer, N 8 0.00004098 Manufacturing 36/37/39 26-36/37 P338 For inspection purposes only. 030SMConsent BEI of copyright Solution owner B (Annualrequired for Usageany other 38 use. L) H314, P280, 100FD00 P305, P351, 38 Sodium hydroxide 1310-73-2 Xn, C 0.00004 0.00004 Manufacturing 35 26-37/39-45 P338, P310 031SM BEI Solution C (Annual Usage 31 L) 100FD00 21 10102-17-7 Xi 0.0000496 0.0000496 Manufacturing N/A N/A 034SM GLUCOSE SOLUTION (50%) (Annual Usage 60 L) 100FD00 13 Glucose monohydrate 14431-43-7 Xi, Xn 0.000012 0.000012 QC N/A N/A 035SM Sodium Bisulphite (Annual Usage 118 L) 100FD00 Sodium hydrogen Xi, mutagenic, 20-22-36-37- 28 sulphite 7631-90-5 sensitizer, N 0.00035 0.00035 Manufacturing 38 26-36 038SM L-Cysteine (Annual Usage 4 L)
Page 171 of 235
EPA Export 29-05-2012:04:39:47
IPPC Application Form V2/12
H315, H319, H335, P261, 100FD00 Cysteine Hydrochlorite P305, P351, 75 Monohydrate 52-89-1 Xi Manufacturing 36 37 38 26 36 P338 039SM EMA-31 (Annual Usage 203 L) H315, H319, H335, P261, 100FD00 Cysteine Hydrochlorite P305, P351, 75 Monohydrate 52-89-1 Xi Manufacturing 36 37 38 26 36 P338 039SM EMA-31 (Annual Usage 203 L) 100FD00 47 Sodium chloride 7647-14-5 Xi 0.00008 0.00008 Manufacturing N/A N/A 100FD00 Disodium hydrogen 23 phosphate 7782-85-6 Xi 0.000001 0.000001 Manufacturing N/A N/A 100FD00 Potassium dihydrogen 51 phosphate 7778-77-0 Xi 0.002 0.002 Manufacturing N/A N/A H225, H315, H317, H319, H335, P210, P261, P280, 100FD00 P305, P351, 35 EMA 31 97-63-2 Xi, Xn 0.00001 0.00001 Manufacturing 10-36-37-38 N/A P338 042SM EDTA (Annual Usage 53 L) 100FD00 H319, P305, 59 EDTA Acid 6381-92-6 N/A Manufacturing N/A N/A P351, P338 044SM NUCLEI STAIN (Annual Usage 36 L) H351, H410, P273, P280, 100FD01 22-40-41- 26-36/37/39- P305, P351, For inspection purposes only. 42 Crystal violet 548-62-9 T, Xn, N Consent 0.000001 of copyright 0.0000owner required01 for Manufacturing any other use. 50/53 46-60-61 P338, P501 100FD00 50 Cirtic Acid Monohydrate 5949-29-1 Xi Manufacturing R36 S26 045SM SAPONIN (100MG/ML) (Annual Usage 16.5 L) H319, H335, 100FD00 P261, P305, 68 Saponin N/A N/A Manufacturing N/A N/A P351, P338
048SM 27% SUCROSE SOLUTION (Annual Usage 80 L) 100FD00 43 Sucrose 57-50-1 N/A 0.00025 0.00025 Manufacturing N/A N/A 049SM ALBUMAX 10% (Annual Usage 68 L) 100FD01 Albumax 1 N/A Xi 0.0001 0.0001 Manufacturing N/A N/A
Page 172 of 235
EPA Export 29-05-2012:04:39:47
IPPC Application Form V2/12
22 050SM WFI (water for injection) (Annual Usage 35106 L) N/A 052SM EAGLES EARLES W/O LAH MEDIUM (Annual Usage 1470 L) 100FD00 0.0000096 08 Eagles Earles MEM N/A N/A 1 0.00000961 Manufacturing N/A N/A 100FD00 Sodium hydrogen 03 carbonate 144-55-8 N/A 0.0000058 0.0000058 Manufacturing N/A N/A 054SM Phosphate Buffer (Annual Usage 19508 L) 100FD00 47 Sodium chloride 7647-14-5 Xi 0.00008 0.00008 Manufacturing N/A N/A 100FD00 Disodium hydrogen 23 phosphate 7782-85-6 Xi 0.000001 0.000001 Manufacturing N/A N/A 100FD00 Potassium dihydrogen 51 phosphate 7778-77-0 Xi 0.002 0.002 Manufacturing N/A N/A 055SM Trypticase Soy Broth (Annual Usage 2148 L) 100FD01 41 Trypticase soy broth 7647-14-5 Xi 0.00003 0.00003 Manufacturing 36/37/38 7-22-26-36 064SM Antifoam C (Annual Usage 34 L) 100FD00 47 Sodium chloride 7647-14-5 Xi 0.00008 0.00008 Manufacturing N/A N/A 100FD00 Disodium hydrogen 23 phosphate 7782-85-6 Xi 0.000001 0.000001 Manufacturing N/A N/A 100FD00 Potassium dihydrogen 51 phosphate 7778-77-0 Xi 0.002 0.002 Manufacturing N/A N/A H302, H315, 100FD00 22-38-40- H351, H373, 70 Antifoam C Emulsion 67-66-3 Xn 200ml 100ml Manufacturing 48/20/22 36/37 P281 068SM Sorbitol For Solution inspection (40%)purposes only.(Annual Usage 3.2 L) 100FD00 Consent of copyright owner required for any other use. 74 Sorbitol instant 50-70-4 N/A 0.0004 0.0004 Manufacturing N/A N/A 070SM NZ Amine (Annual Usage 106 L) 100FD01 16 NZ Amine NS N/A N/A 0.0002 0.0002 Manufacturing N/A N/A 071SM 10% ALUMINIUM CHLORIDE SOLN. (Annual Usage 128.04 L) H314, P280, 100FD01 Aliminium chloride P305, P351, 19 hexhydrate 7784-13-6 C 0.0001 0.0001 Manufacturing 34 1/2-7/8-28-45 P338, P310 072SM 15.75% Trisodium Phosphate Solution (Annual Usage 132 L) 100FD01 Trisodium phosphate 18 dodecahydrate 10101-89-0 Xi 0.0001575 0.0001575 Manufacturing N/A N/A 073SM SODIUM ACETATE SOLUTION (Annual Usage 8 L)
Page 173 of 235
EPA Export 29-05-2012:04:39:47
IPPC Application Form V2/12
100FD01 Sodium acetate 17 trihydrate 6131-90-4 Xi 0.0001 0.0001 Manufacturing N/A 24/25 074SM Normal Saline Solution (Annual Usage 322 L) 100FD00 47 Sodium chloride 7647-14-5 Xi 0.00008 0.00008 Manufacturing N/A N/A 075SM ALUMINIUM PHOSPHATE SOLUTION (Annual Usage 124 L) 050SM WFI as above as above as above as above Manufacturing as above as above H314, P280, 10% ALUMINIUM P305, P351, 071SM CHLORIDE SOLN. as above as above as above as above Manufacturing as above as above P338, P310 15.75% Trisodium 072SM Phosphate Solution as above as above as above as above Manufacturing as above as above 076SM 1% POLYBRENE SOLUTION (Annual Usage 7 L) 100FD00 73 Polybrene 28728-55-4 N/A 0.00001 0.00001 Manufacturing N/A N/A H302 081SM Cytodex Microcarrier Beads (Annual Usage 11.4 L) 100FD01 Cytodex III Microcarrier 24 Beads 88895-19-6 N/A Manufacturing N/A N/A 500FD00 11-38-50/53- 37 Sigmacote N/A F+, Xn, N, C 50ml 15ml Manufacturing 65-67-34 60-61-62 089SM Sorbitol Solution 1% (Annual Usage 1.95 L) 100FD00 74 Sorbitol instant 50-70-4 N/A 0.0004 0.0004 Manufacturing N/A N/A 090SM HEPES BLENDING DILUENT (Annual Usage 1856 L) 100FD00 0.0000096 08 Eagles Earles MEM N/A N/A 1 0.00000961 Manufacturing N/A N/A 100FD01 0.0000047 0.00000476 59 Hepes acid 7365-45-9 Xi 66 6 Manufacturing N/A N/A 100FD00 Sodium hydrogen For inspection purposes only. 03 carbonate 144-55-8 N/A Consent 0.0000058 of copyright 0.0000058 owner required for Manufacturing any other use. N/A N/A 128 SM OPTIMEM IRRADIATED NO LAH (Annual Usage 4230 L) 100FD01 Optimem 50x Salts 1 60 solution N/A Xi 50ml 20ml Manufacturing N/A N/A 100FD01 Optimex 50x Acid 61 soluble solution 7647-01-0 T, C, Xi 50ml 20ml Manufacturing N/A N/A 100FD01 Optimem50x Salts II 62 solution 7647-14-5 Xi 50ml 20ml Manufacturing N/A N/A 100FD00 Sodium hydrogen 03 carbonate 144-55-8 N/A 0.0000058 0.0000058 Manufacturing N/A N/A 136SM 40 x Trypsin Solution 100FD00 47 Sodium chloride 7647-14-5 Xi 0.00008 0.00008 Manufacturing N/A N/A 100FD00 Potassium chloride 7747-40-7 N/A 0.000004 0.000004 Manufacturing N/A N/A
Page 174 of 235
EPA Export 29-05-2012:04:39:47
IPPC Application Form V2/12
42 100FD00 13 Glucose monohydrate 14431-43-7 Xi, Xn 0.000012 0.000012 QC N/A N/A 100FD00 03 Sodium Bicarbonate 144-55-8 Xi 0.0000004 0.0000004 QC N/A N/A 100FD01 Sodium dihydrogen 0.0000001 81 phosphate dihydrate 13472-35-0 Xi 4 0.00000014 Manufacturing N/A N/A H319, H315, H334, H335, P261, P305, 100FD00 22-24-26- P351, P338, 66 Porcine trypsin 7/7/9002 Xi, Sensitizer 0.000006 0.000006 QC 36/37/38-42 36/37 P342, P311 158SM D-Biotin Solution 100FD02 0.0000000 15 d-Biotin 58-85-5 Xi 5 0.00000005 Manufacturing N/A N/A 100FD02 49 Ethanol 64-17-5 Xi, F+ 500ml 250ml Manufacturing 11 7/8/2016 H225, P210 159SM Vitamin A acetate 100FD02 Vitamin A Acetate 13 (powder) 127-47-9 Xi 0.0000001 0.0000001 Manufacturing N/A N/A 100FD02 49 Ethanol 64-17-5 Xi, F+ 500ml 250ml Manufacturing 11 7/8/2016 H225, P210 166SM Sodium Hypochlorite Solution 500FD00 26-36/37/39- 32 Sodium Hypochlorite 7681-52-9 C 50 L 550 L Manufacturing 34 45 168 SM Neocryl A640 (Annual Usage 478.6 L) 100FD00 47 Sodium chloride 7647-14-5 Xi 0.00008 0.00008 Manufacturing N/A N/A 100FD02 Possibly For inspection purposes only. 30 NeoCryl A-640 7732-18-5 carcinogenic Consent 1 L of copyright 500mlowner required for Manufacturing any other use. N/A N/A 170SM PD Adjuvants 0.65% 100FD02 36 Carbopol 1/4/9003 Xi 0.0000065 0.0000065 Manufacturing N/A N/A 171SM Phosphate Buffer pH 7.2 100FD00 Potassium dihydrogen 51 phosphate 7778-77-0 Xi 0.0000003 0.0000003 Manufacturing N/A N/A 100FD02 Disodium hydrogen 38 phosphate 7782-85-6 N/A Manufacturing N/A N/A 172SM 0.4M Sodium Phosphate 100FD01 Trisodium phosphate 18 dodecahydrate 10101-89-0 Xi 0.0001575 0.0001575 Manufacturing N/A N/A 173SM 0.4M Aluminium Chloride 100FD01 Aluminium chloride 7784-13-6 C 0.0001 0.0001 Manufacturing 34 1/2-7/8-28-45
Page 175 of 235
EPA Export 29-05-2012:04:39:47
IPPC Application Form V2/12
19 hexhydrate 174SM PBS (Duvaxyn) 100FD00 42 Potassium chloride 7747-40-7 N/A 0.000004 0.000004 Manufacturing N/A N/A 100FD00 47 Sodium chloride 7647-14-5 Xi 0.0000004 0.0000004 QC N/A N/A 100FD00 Potassium dihydrogen 51 phosphate 7778-77-0 Xi 0.0000003 0.0000003 Manufacturing N/A N/A 100FD02 Disodium hydrogen 38 phosphate 7782-85-6 N/A Manufacturing N/A N/A 175SM PD Adjuvants 0.8% 100FD02 36 Carbopol 1/4/9003 Xi 0.0000065 0.0000065 Manufacturing N/A N/A 176SM Phosphate Buffer pH 7.5 100FD01 Sodium dihydrogen 0.0000001 81 phosphate dehydrate 13472-35-0 Xi 4 0.00000014 Manufacturing N/A N/A 100FD02 Disodium hydrogen 38 phosphate 7782-85-6 N/A Manufacturing N/A N/A 177 SM 0.465M Phosphate Buffer 100FD00 Potassium dihydrogen 51 phosphate 7778-77-0 Xi 0.0000003 0.0000003 Manufacturing N/A N/A 100FD02 Disodium hydrogen 38 phosphate 7782-85-6 N/A Manufacturing N/A N/A 178SM G.L.S solution 100FD01 82 Gelatine 9000-70-8 N/A Manufacturing N/A N/A 100FD01 0.0001821 83 Lactose 63-42-3 Xi 1 0.00018211 Manufacturing N/A N/A 100FD00 For inspection purposes only. 43 Sucrose 57-50-1 N/A Consent 0.00025 of copyright 0.00025owner required for Manufacturin any other use. g N/A N/A 179SM MEM Blending Diluent (Annual Usage 100L) 100FD02 44 MEM w/o Phenol Red N/A N/A Manufacturing N/A N/A 100FD01 0.0000047 0.00000476 59 Hepes acid 7365-45-9 Xi 66 6 Manufacturing N/A N/A 100FD00 Sodium hydrogen 03 carbonate 144-55-8 N/A 0.0000058 0.0000058 Manufacturing N/A N/A 180SM Nat SP OIL 100FD01 Pluronic L-121 33 Surfactant 11/6/9003 N/A 50ml 20ml Manufacturing N/A N/A H315, H319, 100FD02 H335, P261, 46 Natural Squalane 111-02-4 N/A Manufacturing N/A N/A P305, P351,
Page 176 of 235
EPA Export 29-05-2012:04:39:47
IPPC Application Form V2/12
P338 100FD00 Tween 80 ( Polysorbate 26 80) 1338-41-6 Xi 5ml 1.26ml Manufacturing N/A N/A
182SM MEM Glasgow 100FD02 55 MEM glasgow N/A N/A 0.0000142 0.0000142 Manufacturing N/A N/A 100FD00 Sodium hydrogen 03 carbonate 144-55-8 N/A 0.0000058 0.0000058 Manufacturing N/A N/A H317, H334, 100FD00 P261, P280, 17 Gentamycin sulphate 1405-41-0 N/A 0.000225 0.000225 Manufacturing Xi, Hazardous N/A P342, P311 185M PBS BTV 100FD00 42 Potassium chloride 7747-40-7 N/A 0.000004 0.000004 Manufacturing N/A N/A 100FD00 Potassium dihydrogen 51 phosphate 7778-77-0 Xi 0.002 0.002 Manufacturing N/A N/A 100FD02 Disodium Phosphate 50 Dodecahydrate 7558-79-4 N/A Manufacturing N/A N/A 100FD00 47 Sodium chloride 7647-14-5 Xi 0.0000004 0.0000004 QC N/A N/A Phenol Red H315, H319, H335, P261, Phenol P305, P351, Red 143-74-8 Xi Manufacturing R 36 37 38 26 P338 187SM Trypsin Solution 1.5% H319, H315, H334, H335, For inspection purposes only. Consent of copyright owner required for any other use. P261, P305, 100FD00 22-24-26- P351, P338, 66 Porcine trypsin 7/7/9002 Xi, Sensitizer 0.000006 0.000006 QC 36/37/38-42 36/37 P342, P311 H317, H334, 100FD00 P261, P280, 17 Gentamycin sulphate 1405-41-0 Xi, Hazardous 0.000225 0.000225 Manufacturing N/A P342, P311 188SM 1M Sodium Thiosulphate 100FD00 Sodium thiosulphate 21 pentahydrate 10102-17-7 Xi 0.0000496 0.0000496 Manufacturing N/A N/A 189M L2 Freeze Drying Stabilizer 100FD02 58 Dextran 40 9004-54-0 N/A Manufacturing N/A N/A 100FD02 Enzymaticaly Hydrolyzed 59 Casein 65072-00-6 N/A Manufacturing N/A N/A
Page 177 of 235
EPA Export 29-05-2012:04:39:47
IPPC Application Form V2/12
100FD01 0.0001821 83 Lactose 63-42-3 Xi 1 0.00018211 Manufacturing N/A N/A 100FD02 60 Sorbitol 70% Solution N/A N/A Manufacturing N/A N/A H314, P280, 100FD00 P305, P351, 38 Sodium hydroxide 1310-73-2 Xn, C 0.00004 0.00004 Manufacturing 35 26-37/39-45 P338, P310 190SM DMEM with LAH 100FD02 64 DMEM w/o Glutamine N/A N/A Manufacturing N/A N/A 100FD00 68458-87-7 65 Lactalbumin hydrolysate Xi 0.0000005 0.0000005 Manufacturing N/A N/A 100FD00 Sodium hydrogen 03 carbonate 144-55-8 N/A 0.0000058 0.0000058 Manufacturing N/A N/A 191M L Glutamine (Felocell) 100FD02 64 DMEM w/o Glutamine N/A N/A Manufacturing N/A N/A 100FD00 68458-87-7 65 Lactalbumin hydrolysate Xi 0.0000005 0.0000005 Manufacturing N/A N/A 100FD00 Sodium hydrogen 03 carbonate 144-55-8 N/A 0.0000058 0.0000058 Manufacturing N/A N/A 191M L Glutamine (Felocell) 100FD02 62 L Glutamine 58-85-9 N/A Manufacturing N/A N/A 192SM Gentamycin 45mg/ml H317, H334, 100FD00 P261, P280, 17 Gentamycin sulphate 1405-41-0 N/A 0.000225 0.000225 Manufacturing Xi, Hazardous N/A P342, P311
For inspection purposes only. 100FD00 Consent of copyright owner required for any other use. H319, P305, 52 EDTA Acid Disodium Salt 6381-92-6 T, Xi, Xn 0.0002 0.0002 Manufacturing 36/37/38 26-36/37/39 P351, P338 100FD02 Sodium Bisulphite 63 Monohydrate 10034-88-5 N/A Manufacturing N/A N/A 193SM HAL MEM Blending Diluent 100FD00 68458-87-7 65 Lactalbumin hydrolysate Xi 0.0000005 0.0000005 Manufacturing N/A N/A 100FD02 68 HAL MEM Powder N/A N/A Manufacturing N/A N/A 100FD00 Sodium hydrogen 03 carbonate 144-55-8 N/A 0.0000058 0.0000058 Manufacturing N/A N/A PRODUCTS AV20108 Confidential – Available Felocell Products N/A N/A Veterinary vaccine N/A N/A 1 - to the Agency upon
Page 178 of 235
EPA Export 29-05-2012:04:39:47
IPPC Application Form V2/12
FELOCEL request. L CVR; AV20208 1 - FELOCEL L CVR C; AV20308 1 - FELOCEL L RC AV30108 2 - STELLAM UNE MYCOPLA Confidential – Available SMA; Stellamune Vaccines N/A N/A to the Agency upon Veterinary vaccine N/A N/A AV30208 request. 1 - STELLAM UNE ONCE AV10100 01IEU - Duvaxyn IE Filled Unlabelle d Vial; AV10200 01IEU - Confidential – Available Duvaxyn Duvaxyn Products N/A N/A to For the inspection Agency purposes upon only. Veterinary vaccine N/A N/A IET Filled Consent of copyright owner required for any other use. request. Unlabelle d Vial; AV10300 01IEU - Duvaxyn T Filled Unlabelle d Vial; Duramun Confidential – Available e Range Vaccine Product N/A N/A to the Agency upon Veterinary vaccine N/A N/A (Duramu request. ne 7,8) Bronchish Vaccine Product N/A N/A Confidential – Available Veterinary vaccine N/A N/A
Page 179 of 235
EPA Export 29-05-2012:04:39:47
IPPC Application Form V2/12
ield to the Agency upon request. Pentofel, Fel-O- Confidential – Available Vax iCHP, Vaccine Product N/A N/A to the Agency upon Veterinary vaccine N/A N/A iCHPChla request. m Confidential – Available Feline 3 Vaccine Product N/A N/A to the Agency upon Veterinary vaccine N/A N/A (Katavac) request. Confidential – Available Triangle Vaccine Product N/A N/A to the Agency upon Veterinary vaccine N/A N/A 3,4,5 request. Confidential – Available Artevac Vaccine Product N/A N/A to the Agency upon Veterinary vaccine N/A N/A request. Confidential – Available Duvaxyn Vaccine Product N/A N/A to the Agency upon Veterinary vaccine N/A N/A Rotavirus request. Confidential – Available West Nile Vaccine Product N/A N/A to the Agency upon Veterinary vaccine N/A N/A request. Confidential – Available Fluvac T Vaccine Product N/A N/A to the Agency upon Veterinary vaccine N/A N/A request. Refrigerants used on site 69kg stored within equipment. No Asphyxiant in additional refrigerant high N/A R134A 811-97-2 N/A stored. For inspection purposes only. Refrigerant concentrations. S9, S23 Consent of copyright owner required for any other use. 0.95kg stored within equipment. No additional refrigerant N/A Mixed HFC N/A stored. Refrigerant 18.6kg stored within equipment. No additional refrigerant S23, S24, S23, N/A R22 75-45-6 Xi stored. Refrigerant R59 S59 1.22kg stored within equipment. No additional refrigerant S47, S41, N/A R23 75-46-7 Xi stored. Refrigerant N/A S24/25 N/A R290 74-98-6 F 0.222kg stored within Refrigerant R7, R9, R12, S2, S9, S16,
Page 180 of 235
EPA Export 29-05-2012:04:39:47
IPPC Application Form V2/12
equipment. No R18, R21 S18, S26, S33, additional refrigerant S35, S43 stored. 98.88kg stored in use 354-33-6, within equipment. No S9, S15, S23, 420-46-2, additional refrigerant R20, R34, R44, S36, S41, S51, N/A R404A 811-97-2 Xi stored on-site. Refrigerant R59 S59, S61 0.892kg stored in use 75-10-5 within equipment. No 354-33-6 additional refrigerant N/A R407D 811-97-2 N/A stored on-site. Refrigerant R12 63.5kg stored in use within equipment. No 75-10-5 additional refrigerant S47, S41, N/A R410A 354-33-6 Xi stored on-site. Refrigerant R12 S24/25 270kg stored in use within equipment. No 354-33-6 additional refrigerant S47, S41, N/A R507 420-46-2 Xi stored on-site. Refrigerant N/A S24/25 1.02kg stored in use within equipment. No 75-46-7 additional refrigerant N/A R508 76-16-4 N/A stored on-site. Refrigerant 1.96kg stored in use within equipment. No 75-46-7 additional refrigerant N/A R508B 76-16-4 N/A stored on-site. Refrigerant 0.275kg stored in use within equipment. No additional For inspection refrigerant purposes only. Consent of copyright owner required for any other use. N/A R600A 106-97-8 N/A stored on-site. Refrigerant R12 S2, S16 N/A R407C FUELS and ENERGY 4,284,927k Domestic and N/A Electricity N/A N/A N/A W manufacturing N/A N/A R45, R51/53, N/A Light Fuel Oil N/A F, I, 43,500 L 255,812 L Fuel for boilers R52/53, R66 S24, S61 Diesel (for standby N/A generators) 68476-30-2 F, I, 3,000 L 3,000 L Emergency back up R 40 S2, S36/37 Domestic and N/A Water (Municipal Supply) 7732-18-5 N/A N/A 27,292m3 manufacturing N/A N/A
Page 181 of 235
EPA Export 29-05-2012:04:39:48
IPPC Application Form V2/12
Notes: 1. In cases where a material comprises a number of distinct and available dangerous substances, please give details for each component substance. 2. Article 2(2) of S.I. No. 116/2003 3. Schedules 9 and 10 of S.I. No. 62/2004 (as amended by S.I. No. 271/2008) 4. EC Regulation 1272/2008 (Chemicals Act 2008 (13 of 2008) and 2010)
Note: P = Precautionary Statement
For inspection purposes only. Consent of copyright owner required for any other use.
Page 182 of 235
EPA Export 29-05-2012:04:39:48
IPPC Application Form V2/12
Table G.1(ii) Details of Process related Raw Materials, Intermediates, Products, etc., used or generated on the site
An excel file of this information has been included on CD with this application for ease of review.
Ref. Odour Pollutants No or Material/ (Tick and specify Group/Family Number) Code Substance (1) Odourous Threshold EC EO (Surface Waters) EC EO Groundwater) Yes/No Description Regulations 2009 Regulations 2010 µg/m 3 Specific Priority (hazardous) Hazardous 1 Non- pollutants substances hazardous1
AFPV AEQUIS FELINE No data No data available No data PANLEUKOPENIA available available AFVR AEQUIS FELINE No data No data available No data RHINOTRACHEITIS available available Not yet Amphigen Base No data No data available No data assigned available available 800FD0027 Antigen - Tetanus No data No data available No data Toxoid available available BB Bordetella Brochiseptica No data No data available No data available available BRSV(OP) BOVINE RESPIRATORY No data No data available No data SYNCYTICAL available available 015SM SGGK Solution 2 No data No data available No data Data not available for viruses and antigens available For inspection purposesavailable only. Raw materials utilised in production are detailed below BVD(OP) BOVINE VIRUS No data No dataConsent available of copyright owner No required data for any other use. DIARRHOEA ANTIGEN available available N/A BP-800 No Odourless - 800FD0044 CAV2 Antigen Stock No data No data available No data (Roller Bt) available available 800FD0085 CCV CONCENTRATED No data No data available No data available available 800FD0142 CDV (ond) Antigen Stk No data No data available No data Biorctor available available N/A Chem-aqua 900 Yes Pungent 5000 800FD0173 CPI Antigen Stock No data No data available No data (Bioreactor) available available
Page 183 of 235
EPA Export 29-05-2012:04:39:48
IPPC Application Form V2/12
800FD0045 CPV Antigen Stock No data No data available No data (Bioreactor) available available 016SM SGGK Solution 1 Yes Characteristic No data available Not yet Drakeol 5 No data No data available No data assigned available available N/A Durapipes solvent No data No data available No data cement available available EAVK EQUINE ARTERITIS No data No data available No data VIRUS ANT STK available available EIVK EQUINE INFLUENZA No data No data available No data VIRUS ANTIGEN available available EIVL EQUINE INFLUENZA No data No data available No data VIRUS ANTIGEN available available EIVP EQUINE INFLUENZA No data No data available No data VIRUS ANTIGEN available available ROTA EQUINE ROTAVIRUS No data No data available No data ANTIGEN available available 800FD0201 FCV-255 Antigen No data No data available No data available available Data not available for viruses and antigens 800FD0202 FCV-DD 1 Antigen No data No data available No data Raw materials utilised in production are detailed below available available FCV FELINE CALICI VIRUS No data No data available No data ANTIGEN available available FCP 5UM FELINE CHLAMYDIA No data No data available No data PSITTACI available available FCP 75UM FELINE CHLAMYDIA No data No data available No data PSITTARI available available FELV FELINE LEUKEMIA No data No data available For inspection purposes No data only. VIRUS ANT STK available Consent of copyright owneravailable required for any other use.
FPV FELINE No data No data available No data PANLEUKOPENIA VIRUS available available FVR FELINE VIRUS No data No data available No data RHINOTRACHEITIS available available
AV201081 - Felocell Products No data No data available No data FELOCELL available available CVR; AV202081 - FELOCELL CVR C; AV203081 -
Page 184 of 235
EPA Export 29-05-2012:04:39:48
IPPC Application Form V2/12
FELOCELL RC 800FD0133 FELV 100X Released No data No data available No data available available 800FD0203 FPV Antigen No data No data available No data available available 800FD0200 FVR Antigen No data No data available No data available available 500FD0055 General purpose Yes Characteristic No data degreaser 603 available 178SM GLS Solution No data No data available No data available available 090SM HEPES BLENDING No data No data available No data DILUENT available available IBR(OP) INFECTIOUS BOVINE No data No data available No data available available None Insulating varnish Yes Characteristic No data available Not yet Irradiated porcine No data No data available No data assigned serum available available 038SM L-cysteine solution No data No data available No data Data not available for viruses and antigens available available Raw materials utilised in production are detailed below 011SM LACTALBUMIN No data No data available No data
HYDROLYSATE 5% available available 800FD0077 Leptospira Canicola No data No data available No data (OMC) available available 800FD0078 Leptospira No data No data available No data Icterohaemomhapiae available available 300FD0210 Mycoplasma agar No data No data available For inspection purposes No data only. available Consent of copyright owneravailable required for any other use.
N/A Na 104C No data No data available No data available available 045SM Saponin Yes characteristic No data available 500FD0042 Neodisher Alka 240 Yes characteristic No data available 055SM TSB Yes characteristic No data available 070SM NZ AMINE 20% No data No data available No data available available PI3(OP) PARAINFLUENZA VIRUS No data No data available No data TYPE 3 available available
Page 185 of 235
EPA Export 29-05-2012:04:39:48
IPPC Application Form V2/12
Not yet Polysorbate 30 No data No data available No data assigned available available Not yet PPLO Broth Yes Characteristic No data assigned available N/A RS electronic resin flux Yes Mild resinous No data available N/A Shell ondina oil 917 No Odourless - N/A Silicone sealant Yes Acetic acid smell No data available N/A Spectrus OX1271 Yes Slight pungent No data available 500FD0006 Stainless steel polish No data No data available No data available available AV301082 - Stellamune Vaccines No data No data available No data STELLAMUN available available Data not available for viruses and antigens E Raw materials utilised in production are detailed below MYCOPLASM A; AV302081 - STELLAMUN E ONCE N/A Surtest smoke detector No data No data available No data tester available available N/A Tangit ABS Yes Intensive of ester and No data ketone available 006SM TRYPSIN VERSENE No data No data available No data available available Not yet USP System Suitability No No - assigned kits For inspection purposes only. 800FD0190 West Nile Viral Antigen No data No dataConsent available of copyright owner No required data for any other use.
available available 300FD0009 Sulphuric Acid Yes Characteristic 0.001 Undetermine d 300FD0097 Calcium Carbonate No data No data available No data available available 300FD0268 ABTS Substrate No data No data available No data available available N/A Dimethylformamide Yes Amine like No data available New request Chromium(III)Chloride No data No data available No data Chromium hexahydrate available available (III) (M=266.45)
Page 186 of 235
EPA Export 29-05-2012:04:39:48
IPPC Application Form V2/12
New request Conjugate: peroxidase New product New product - MSDS New product New product New product - MSDS not New product New product - conjugated goat anti - MSDS not not available yet - MSDS not - MSDS not available yet - MSDS not MSDS not guinea pig IgG available yet available yet available yet available yet available yet New request Guinea pig complement No data No data available No data New product New product - MSDS not New product New product - available available - MSDS not available yet - MSDS not MSDS not available yet available yet available yet New request Indubiose agar New product New product - MSDS New product New product New product - MSDS not New product New product - A37(agarose) - MSDS not not available yet - MSDS not - MSDS not available yet - MSDS not MSDS not available yet available yet available yet available yet available yet New request Negative guinea pig New product New product - MSDS New product New product New product - MSDS not New product New product - serum - MSDS not not available yet - MSDS not - MSDS not available yet - MSDS not MSDS not available yet available yet available yet available yet available yet New request Sheep blood in alsever New product New product - MSDS New product New product New product - MSDS not New product New product - - MSDS not not available yet - MSDS not - MSDS not available yet - MSDS not MSDS not available yet available yet available yet available yet available yet New request Skimmilk No data No data available No data available available New request Substrate: ABTS No data No data available No data sabstrate system available available New request Tetanus Toxin No data No data available No data New product New product - MSDS not New product New product - available available - MSDS not available yet - MSDS not MSDS not available yet available yet available yet New request Veronal buffer (5x No data No data available No data New product New product - MSDS not New product New product - concentrated) available available - MSDS not available yet - MSDS not MSDS not available yet available yet available yet None Aluminium phosphate No data No data available No data available available None Yet Amphigen Base New product New product - MSDS New product New product New product - MSDS not New product New product - - MSDS not not available yet - MSDS not - MSDS not available yet - MSDS not MSDS not For inspection purposes only. available yet Consent of copyright owneravailable required for yetany otheravailable use. yet available yet available yet None Yet Dextrose Solution New product New product - MSDS New product - MSDS not not available yet - MSDS not available yet available yet None Yet Drakeol 5 New product New product - MSDS New product New product New product - MSDS not New product New product - - MSDS not not available yet - MSDS not - MSDS not available yet - MSDS not MSDS not available yet available yet available yet available yet available yet None Yet Polysorbate 30 New product New product - MSDS New product New product New product - MSDS not New product New product - - MSDS not not available yet - MSDS not - MSDS not available yet - MSDS not MSDS not available yet available yet available yet available yet available yet None Yet Quest 412 New product New product - MSDS New product New product New product - MSDS not New product New product - - MSDS not not available yet - MSDS not - MSDS not available yet - MSDS not MSDS not available yet available yet available yet available yet available yet
Page 187 of 235
EPA Export 29-05-2012:04:39:48
IPPC Application Form V2/12
None Yet Sorbitan Monooelate New product New product - MSDS New product - MSDS not not available yet - MSDS not available yet available yet None Yet USP Water No Odourless - None Yet Yeast Extract Solution New product New product - MSDS New product New product New product - MSDS not New product New product - - MSDS not not available yet - MSDS not - MSDS not available yet - MSDS not MSDS not available yet available yet available yet available yet available yet RD1205 PA3 No Odourless 0.5 Barium 102 Mechanical vaccum Yes Characteristic of oil No data Toluene, Benzene Persistent pump oil available Xylene hydrocarbons and persistent and bioaccumulab le organic toxic substances. SAE-90W Yes Slight hydrocarbon No data Toluene, Benzene Persistent available Xylene hydrocarbons and persistent and bioaccumulab le organic toxic substances. 100FD0267 Bovine Calf Serum Yes Blood odour NA None Yet Antifoam Solution 50% New product New product - MSDS New product New product New product - MSDS not New product New product - - MSDS not not available yet For inspection purposes- MSDS only. not - MSDS not available yet - MSDS not MSDS not Consent of copyright owner required for any other use. available yet available yet available yet available yet available yet Liquid Nitrogen No Odourless - NA WD 40 Yes Characteristic No data Toluene, Benzene Persistent available Xylene hydrocarbons and persistent and bioaccumulab le organic toxic substances. 300FD0263 Hydranal Composite No data No data available No data Substances available available and
Page 188 of 235
EPA Export 29-05-2012:04:39:48
IPPC Application Form V2/12
preparations, or the breakdown products of such, which have been proved to possess carcinogenic or mutagenic properties or properties which may affect steroidogenic, thyroid, reproduction or other endocrine related functions in or via the aquatic environment. NA 3 in 1 oil Yes Characteristic No data Toluene, Benzene available Xylene DMEM w/o L glut No data No data available No data available available L2 Freeze Drying Stabilizer For inspection purposes only. Consent of copyright owner required for any other use. Pancreatic Digest of Casein
100FD0216 100 x MEM Vitamin No No odour Not solution applicable 500FD0057 CIP 100 Yes Slight chemical odour NA NA Biochem 1004 Yes Chlorine 1.5 NA Oxychem 102 Yes Pungent, sulphur 5.3 Metals Metals dioxide NA Polychem B302 Yes Slight chemical odour 0 Biocides NA Polychem C1033EV` Yes Slight chemical odour 0 MSDS not MSDS not available MSDS not Acetodiphosp available available honic acid
Page 189 of 235
EPA Export 29-05-2012:04:39:48
IPPC Application Form V2/12
None Yet Porcine Serum No data No data available No data New product New product - MSDS not New product New product - available available - MSDS not available yet - MSDS not MSDS not available yet available yet available yet None Yet PPLO Broth New product New product - MSDS not New product New product - - MSDS not available yet - MSDS not MSDS not available yet available yet available yet Alchem 1102 Yes Amine - fishy 41 Powder HAL MEM media No data No data available No data available available Not yet 2-Bromoethylamine No data No data available No data assigned Hydrobromide available available 300FD0036 James Test Kit No data No data available No data available available 500FD0036 Acetone Yes Pungent 100- Undetermine 150ppm d N/A Alcatel 102 Mechanical Yes Petroleum hydrocarbon No data (Possible vacuum pump oil odour available carcinogen) Not yet Antifoam SAG 471 Yes Mild Polyether No data assigned available Not yet Cysteine Hydrochloride No data No data available No data assigned Solution available available Diesel (for standby Yes Pungent petroleum 0.11ppm Toluene, Benzene Persistent generators) odour Xylene hydrocarbons and persistent and bioaccumulab le organic For inspection purposes only. toxic Consent of copyright owner required for any other use. substances
500FD0023 Dilute sulphuric acid No data No data available No data Undetermine available available d Not yet EDTA No data No data available No data assigned available available 300FD0049 Ethanol Yes Characteristic 1880 Undeter mine d 100FD0135 Formalin Yes Pungent No data Possibly Biocide Non- available carcinogenic hazardous 500FD0039 Formalin Yes Pungent No data Possibly Biocide Non- available carcinogenic hazardous 034SM GLUCOSE SOLUTION No Odourless - (50%)
Page 190 of 235
EPA Export 29-05-2012:04:39:48
IPPC Application Form V2/12
100FD0031 Glycerol No Odourless - Undertermine d 100FD0019 Hydrochloric Acid Yes Acidic 15000 024SM HYDROCHLORIC ACID Yes Acidic 15000 (1M) 500FD0059 Hydrogen peroxide No Odourless 1ppm 500FD0043 Isopropyl alcohol Yes Alcohol like 200ppm Undetermine d None Klericide Biocide A Yes Faint Odour No data Biocide Alkyl available dimethyl benzyl ammonium chloride Not yet L-Cystene No data No data available No data assigned Hydrochloride available available 300FD0235 Methanol Yes Characteristic 270 N/A Microbicide WT Yes Aromatic No data Biocide available 500FD0029 Neutrailising agent, Yes Characteristic No data Undetermine neodisher z available d 076SM 1% POLYBRENE No data No data available No data SOLUTION available available 073SM SODIUM ACETATE Yes Slight acetic acid odour No data SOLUTION available 100FD0038 Sodium hydroxide No Odourless - Undertermine d 022SM SODIUM HYDROXIDE No Odourless - Undertermine (1M) d 027SM SODIUM HYDROXIDE No Odourless For inspection purposes - only. Undertermine (5M) Consent of copyright owner required for any other use. d
300FD0264 Sodium thiosulphate No data No data available No data Undetermine available available d Not yet Thimerosal Yes Characteristic No data Metals Mercury assigned available 019SM THIMEROSAL (10%) Yes Characteristic No data Metals Mercury available 300FD0075 Trypan blue stain No data No data available No data available available Substances and preparations, or the breakdown
Page 191 of 235
EPA Export 29-05-2012:04:39:48
IPPC Application Form V2/12
products of such, which have been proved to possess carcinogenic or mutagenic properties or properties which may affect steroidogenic , thyroid, reproduction or other endocrine related functions in or via the aquatic environment. 020SM TRYPAN BLUE VITAL No data No data available No data STAIN available available Substances and preparations, or the breakdown products of such, which For inspection purposes only. have been Consent of copyright owner required for any otherproved use. to possess carcinogenic or mutagenic properties or properties which may affect steroidogenic , thyroid, reproduction or other endocrinerel ated
Page 192 of 235
EPA Export 29-05-2012:04:39:48
IPPC Application Form V2/12
functions in or via the aquatic environment. 049SM Albumax No No data available No data available 032SM Neocryl Yes Ammonia Odour No data Possibly available carcinogenic 005SM Gentamycin No data No data available No data available available 075SM ALUMINIUM No data No data available No data PHOSPHATE SOLUTION available available 007SM BSA No Odourless - 031SM BEI SOLN C No Odourless - Substances and preparations, or the breakdown products of such, which have been proved to possess carcinogenic or mutagenic properties or properties which may For inspection purposes only. affect Consent of copyright owner required for any other use. steroidogenic , thyroid, reproduction or other endocrine related functions in or via the aquatic environment. Not yet Dextrose ACS No data No data available No data assigned available available Not yet Dextrose Solution No data No data available No data
Page 193 of 235
EPA Export 29-05-2012:04:39:48
IPPC Application Form V2/12
assigned available available 024SM Hydrochloric acid Yes Pungent 7000 052SM Eagles Earles without No data No data available No data LAH available available 074SM Normal Saline Solution No data No data available No data available available 081SM Cytodex beads No data No data available No data available available 035SM SODIUM BIOSULPHITE Yes Pungent 5000 500FD0032 Sodium Hypochlorite Yes Characteristic No data Non- available hazardous 072SM TRISODIUM No Odourless - PHOSPHATE SOLUTION 001SM Leptospira Yes Characteristic No data Mercury Substances Biocide available and preparations, or the breakdown products of such, which have been proved to possess carcinogenic or mutagenic properties or properties which may affect For inspection purposes only. Consent of copyright owner required for any other use. steroidogenic, thyroid, reproduction or other endocrine related functions in or via the aquatic environment. Metals (mercury) 002SM Eagles Earles No data No data available No data available available
Page 194 of 235
EPA Export 29-05-2012:04:39:48
IPPC Application Form V2/12
071SM 10% ALUMINIUM Yes Characteristic No data CHLORIDE SOLN. available 003SM Polymixin B solution No data No data available No data available available 048SM 27% SUCROSE No Odourless - SOLUTION 004SM NEOMYCIN SOLUTION No data No data available No data available available 049SM ALBUMAX 10% No Odourless - 011SM LAH No data No data available No data available available 014SM Eagles Hepes No data No data available No data available available QC SMPS Blocking reagent( No data No data available No data 082 QCSMPS082 available available 007SM BOVINE SERUM No Odourless - ALBUMIN SOLN Not yet BPC Hyclone Bags 175 N/A N/A N/A N/A N/A N/A N/A assigned L Not yet Bromoethylamine No data No data available No data assigned Hydrobromide Solution available available 200FD0245 Buffer 10 Yes Characteristic No data Tricresyl- available phosphate Hazardous 200FD0245 Buffer 10 Yes Characteristic No data Tricresyl- available phosphate Hazardous None Buffer 13 Yes Characteristic No data Tricresyl- For inspection purposesavailable only. phosphate Consent of copyright owner required for any other use. Hazardous
200FD0244 Buffer 4 Yes Characteristic No data Tricresyl- available phosphate Hazardous 200FD0244 Buffer 4 Yes Characteristic No data Tricresyl- available phosphate Hazardous None Buffer 6 Yes Characteristic No data Tricresyl- available phosphate Hazardous 200FD0246 Buffer 7 Yes Characteristic No data Tricresyl- available phosphate Hazardous
Page 195 of 235
EPA Export 29-05-2012:04:39:48
IPPC Application Form V2/12
200FD0246 Buffer 7 Yes Characteristic No data Tricresyl- available phosphate Hazardous None Buffer 8 Yes Characteristic No data Tricresyl- available phosphate Hazardous N/A Carbon dioxide free No - - water N/A Chem-aqua 130 Yes Sweet No data available 027SM Sodium Hydroxide 5M No Odourless - Undertermine d 039SM EMA-31 No data No data available No data available available 029SM BEI Soln A No data No data available No data Possibly available available carcinogenic 030SM BEI Soln B No Odourless - Possibly carcinogenic 031SM BEI Soln C No Odourless - Possibly carcinogenic 042SM EDTA No data No data available No data available available 044SM Nuclei stain No Odourless - Possibly carcinogenic
179SM MEM Blending Diluent No data No data available No data available available 054SM PBS No data No data available No data available For inspection purposesavailable only. 064SM 0.1% Antifoam C Yes Slight Consent of copyright owner 5000 required for any other use. Chlorofo rm hazardous 128SM OPTIMEM No Odourless - 068SM SORBITOL 40% No Odourless - 050SM WFI (water for No No - injection) 071SM Aluminium chloride No Odourless - 018SM PBS Dulbecco Vogt No data No data available No data available available 072SM Tri Sodium phosphate No Odourless - 075SM Aluminiun phosphate Yes Pungent No data Metals available Not yet Sorbitan Monooelate No data No data available No data
Page 196 of 235
EPA Export 29-05-2012:04:39:48
IPPC Application Form V2/12
assigned available available 089SM SORBITOL SOLUTION No Odourless - 1% 300FD0051 Lead (II) Nitrate No data No data available No data Lead Metals available available N/A Total Tower 33 C Yes Characteristic No data Metals available QC SMPS Wash solution (0.3% No data No data available No data 081 Tween PBS) available available Not yet Yeast Extract Solution No data No data available No data assigned available available Not yet Quest 412, yeast No data No data available No data assigned extract available available
For inspection purposes only. Consent of copyright owner required for any other use.
Page 197 of 235
EPA Export 29-05-2012:04:39:48
IPPC Application Form V2/12
TABLE H.1(i): WASTE - Hazardous Waste Recovery/Disposal
Waste EWC Code Main source 1 Quantity On-site Recovery Off-site Off-site Disposal material / Disposal Recovery, reuse or recycling Tonnes / M3 / month (Method & (Method, (Method, Location month Location ) Location & & Undertaker) Undertaker) Hydrochloric 060102* Laboratory 0.003 0.003 1 - - Disposal - Acid lab Incineration smalls Primary Waste Contractor: Indaver Ireland Disposal/Recovery Site: AVG, Hamburg, Germany. Lab Waste 060106* Laboratory 0.030 0.030 1 - - Disposal - (Acidic) Incineration Primary Waste Contractor: Indaver Ireland Disposal/Recovery For inspection purposes only. Site: AVG, Consent of copyright owner required for any other use. Hamburg, Germany. Lab Waste 060204* Laboratory 0.185 0.185 1 - - Disposal - (Caustic) Incineration Primary Waste Contractor: Indaver Ireland Disposal/Recovery Site: AVG, Hamburg, Germany.
Page 198 of 235
EPA Export 29-05-2012:04:39:48
IPPC Application Form V2/12
Waste EWC Code Main source 1 Quantity On-site Recovery Off-site Off-site Disposal material / Disposal Recovery, reuse or recycling Tonnes / M3 / month (Method & (Method, (Method, Location month Location ) Location & & Undertaker) Undertaker) Organic 070504* Laboratory 0.982 0.982 1 - - Disposal - Solvent Process Incineration Waste Primary Waste (Isopropanol Contractor: ) Indaver Ireland Disposal/Recovery Site: AVG, Hamburg, Germany. Lab Waste 070513* Laboratory 0.083 0.083 1 - - Disposal - (Contains Incineration dangerous Primary Waste substances) Contractor: Indaver Ireland Disposal/Recovery Site: AVG, Hamburg, For inspection purposes only. Germany. Consent of copyright owner required1 for any other use. Waste Paint 080111* Maintenance 0.117 0.117 - - Disposal – Thermal Tins Treatment Primary Waste Contractor: Indaver Ireland Disposal/Recovery Site: Indaver NV, Antwerp, Belgium
Page 199 of 235
EPA Export 29-05-2012:04:39:48
IPPC Application Form V2/12
Waste EWC Code Main source 1 Quantity On-site Recovery Off-site Off-site Disposal material / Disposal Recovery, reuse or recycling Tonnes / M3 / month (Method & (Method, (Method, Location month Location ) Location & & Undertaker) Undertaker) Waste 130205* Machinery As required As required - - Disposal - (Rubia) Oil Incineration Primary Waste Contractor: Indaver Ireland Disposal/Recovery Site: AVG, Hamburg, Germany. Waste 130310* Refrigeration 0.014 0.014 1 - - Disposal - Refrigeration units Incineration Oil Primary Waste Contractor: Indaver Ireland Disposal/Recovery Site: AVG, Hamburg, For inspection purposes only. Germany. Consent of copyright owner required1 for any other use. Waste Fuel 130701* Machinery 0.001 0.001 - - Disposal - Oil Incineration Primary Waste Contractor: Indaver Ireland Disposal/Recovery Site: AVG, Hamburg, Germany.
Page 200 of 235
EPA Export 29-05-2012:04:39:48
IPPC Application Form V2/12
Waste EWC Code Main source 1 Quantity On-site Recovery Off-site Off-site Disposal material / Disposal Recovery, reuse or recycling Tonnes / M3 / month (Method & (Method, (Method, Location month Location ) Location & & Undertaker) Undertaker) Empty Paint 150110* Maintenance 0.001 0.001 1 - - Disposal - tins Incineration Primary Waste Contractor: Indaver Ireland Disposal/Recovery Site: AVG, Hamburg, Germany. Wipes 150202* Machinery 0.049 0.049 1 - - Disposal - contaminate Incineration d with oil Primary Waste Contractor: Indaver Ireland Disposal/Recovery Site: AVG, Hamburg, For inspection purposes only. Germany. Consent of copyright owner required1 for any other use. Waste 160211* Process, 0.075 0.075 - - Recycling Electrical – laboratory, Primary Waste Fridge / canteen Contractor: Freezer Indaver Ireland Final Disposal/Recovery Site: AVG, Hamburg, Germany.
Page 201 of 235
EPA Export 29-05-2012:04:39:49
IPPC Application Form V2/12
Waste EWC Code Main source 1 Quantity On-site Recovery Off-site Off-site Disposal material / Disposal Recovery, reuse or recycling Tonnes / M3 / month (Method & (Method, (Method, Location month Location ) Location & & Undertaker) Undertaker) Waste 160213* Process, office 0.222 0.222 1 - - Recycling Electrical – Primary Waste Mixed WEEE Contractor: Indaver Ireland Final Disposal/Recovery Site: AVG, Hamburg, Germany. Organic 160305* Process 0.013 0.013 1 - - Disposal – Waste Incineration Containing Primary Waste dangerous Contractor: substances Indaver Ireland Disposal/Recovery Site: AVG, Hamburg, For inspection purposes only. Germany. Consent of copyright owner required1 for any other use. Mixed lab 160506* Laboratory 0.436 0.436 - - Disposal – chemicals Incineration (including Primary Waste mixtures) Contractor: Indaver Ireland Disposal/Recovery Site: AVG, Hamburg, Germany.
Page 202 of 235
EPA Export 29-05-2012:04:39:49
IPPC Application Form V2/12
Waste EWC Code Main source 1 Quantity On-site Recovery Off-site Off-site Disposal material / Disposal Recovery, reuse or recycling Tonnes / M3 / month (Method & (Method, (Method, Location month Location ) Location & & Undertaker) Undertaker) Mixed lab 160507* Laboratory 0.007 0.007 1 - - Disposal – smalls Incineration (Inorganic) Primary Waste Contractor: Indaver Ireland Disposal/Recovery Site: AVG, Hamburg, Germany. Mixed lab 160508* Laboratory 0.267 0.267 1 - - Disposal – smalls Incineration (Organic) Primary Waste Contractor: Indaver Ireland Disposal/Recovery Site: AVG, Hamburg, For inspection purposes only. Germany. Consent of copyright owner required for any other use. Waste 160903* Process As required As required - - Disposal - Hydrogen Incineration Peroxide Primary Waste Contractor: Indaver Ireland Disposal/Recovery Site: AVG, Hamburg, Germany.
Page 203 of 235
EPA Export 29-05-2012:04:39:49
IPPC Application Form V2/12
Waste EWC Code Main source 1 Quantity On-site Recovery Off-site Off-site Disposal material / Disposal Recovery, reuse or recycling Tonnes / M3 / month (Method & (Method, (Method, Location month Location ) Location & & Undertaker) Undertaker) Lab Waste 160904* Laboratory As required As required - - Disposal - (Oxidizers – Incineration Others) Primary Waste Contractor: Indaver Ireland Disposal/Recovery Site: AVG, Hamburg, Germany. Reject 180103* Process 0.023 0.023 1 - - Disposal – product Incineration (Vaccines) Primary Waste Contractor: SRCL – Eco Safe Systems Ltd Final Disposal/Recovery For inspection purposes only. Site: AGR MBH, Consent of copyright owner required for any other use. Herten, Germany
Page 204 of 235
EPA Export 29-05-2012:04:39:49
IPPC Application Form V2/12
Waste EWC Code Main source 1 Quantity On-site Recovery Off-site Off-site Disposal material / Disposal Recovery, reuse or recycling Tonnes / M3 / month (Method & (Method, (Method, Location month Location ) Location & & Undertaker) Undertaker) Reject 180103* Process 0.071 0.071 1 Disposal – product Incineration (Vaccines) Primary Waste Contractor: SRCL – Eco Safe Systems Ltd Final Disposal/Recovery Site: Greenstar Recycling, Ballynagragan, Wicklow, Ireland. Reject 180103* Process 0.012 0.012 1 Disposal – product Incineration (Vaccines) Primary Waste Contractor: SRCL – Eco Safe For inspection purposes only. Systems Ltd Consent of copyright owner required for any other use. Final Disposal/Recovery Site: Davis Recycling, Rathcoole, Ireland.
Page 205 of 235
EPA Export 29-05-2012:04:39:49
IPPC Application Form V2/12
Waste EWC Code Main source 1 Quantity On-site Recovery Off-site Off-site Disposal material / Disposal Recovery, reuse or recycling Tonnes / M3 / month (Method & (Method, (Method, Location month Location ) Location & & Undertaker) Undertaker) Reject 180103* Process 0.069 0.069 1 Disposal – product Incineration (Vaccines) Primary Waste Contractor: SRCL – Eco Safe Systems Ltd Final Disposal/Recovery Site: Indaver Medical Services, Wilsele-Leuven, Belgium. Reject 180103* Process 0.345 0.345 1 Disposal – product Incineration (Vaccines) Primary Waste Contractor: SRCL – Eco Safe For inspection purposes only. Systems Ltd Consent of copyright owner required for any other use. Final Disposal/Recovery Site: SRCL Ltd., Knowsthorpe Treatment Works, Leeds, UK.
Page 206 of 235
EPA Export 29-05-2012:04:39:49
IPPC Application Form V2/12
Waste EWC Code Main source 1 Quantity On-site Recovery Off-site Off-site Disposal material / Disposal Recovery, reuse or recycling Tonnes / M3 / month (Method & (Method, (Method, Location month Location ) Location & & Undertaker) Undertaker) Waste from 180202* Process 0.057 0.057 1 - - Disposal – Landfill processes Primary Waste involving Contractor: SRCL live animal Ltd viruses and Final bacteria Disposal/Recovery Site: Drehid Waste Management Facility, Carbury, Kildare, Ireland. Waste from 180202* Process 2.364 2.364 1 - - Disposal – Landfill processes Primary Waste involving Contractor: SRCL live animal Ltd viruses and Final bacteria Disposal/Recovery Site: Drehid Waste For inspection purposes only. Management Consent of copyright owner required for any other use. Facility, Carbury, Kildare, Ireland. Waste 200121* Lighting 0.008 0.008 1 - - Recycling Electrical – Primary Waste Fluorescent Contractor: Tubes Indaver Ireland Final Disposal/Recovery Site: AVG, Hamburg, Germany.
Page 207 of 235
EPA Export 29-05-2012:04:39:49
IPPC Application Form V2/12
Waste EWC Code Main source 1 Quantity On-site Recovery Off-site Off-site Disposal material / Disposal Recovery, reuse or recycling Tonnes / M3 / month (Method & (Method, (Method, Location month Location ) Location & & Undertaker) Undertaker) Waste 200123* General As required As required - Recycling - Electrical Rehab Recycling Ltd, Broomhill Road, Tallaght, Unit 77, Dublin 22. Waste 200135* General As required As required - Recycling - Electrical – Rehab Recycling Mixed WEEE Ltd, Broomhill Road, Tallaght, Unit 77, Dublin 22. Waste 200140* Chilling 0.497 0.497 1 - Recycling Electrical – Indaver, Sligo Chiller Unit Ireland
Interceptor 130503* Wastewater As required As required - - Recovery sludges For inspection purposes only. Primary Waste Consent of copyright owner required for any other use. Contractor: Indaver Ireland Final Disposal/Recovery Site: Irish Lamp Recycling, Ltd.
Page 208 of 235
EPA Export 29-05-2012:04:39:49
IPPC Application Form V2/12
Waste EWC Code Main source 1 Quantity On-site Recovery Off-site Off-site Disposal material / Disposal Recovery, reuse or recycling Tonnes / M3 / month (Method & (Method, (Method, Location month Location ) Location & & Undertaker) Undertaker) Waste HEPA Defined as Process – HEPA As required As required - - Disposal - Landfill filters from waste is filters are Ballynagran clean rooms generated thermally Residual landfill, treated on-site Co.Wicklow Waste HEPA filters are autoclaved out of the antigen production suite and solid waste is bagged inside ‘UN’ biohazard bags for disposal to landfill. Waste Defined as - As required As required - - Disposal - Aerosol Cans waste is For inspection purposes only. Incineration Consent of copyright owner required for any other use. generated Primary Waste Contractor: Indaver Ireland Disposal/Recovery Site: AVG, Hamburg, Germany
Page 209 of 235
EPA Export 29-05-2012:04:39:49
IPPC Application Form V2/12
Waste EWC Code Main source 1 Quantity On-site Recovery Off-site Off-site Disposal material / Disposal Recovery, reuse or recycling Tonnes / M3 / month (Method & (Method, (Method, Location month Location ) Location & & Undertaker) Undertaker) Waste Filters Defined as - As required As required - - Disposal - from waste is Incineration Chemical generated Primary Waste fume hoods Contractor: Indaver Ireland Disposal/Recovery Site: AVG, Hamburg, Germany. Waste Defined as - As required As required - - Disposal - absorbent waste is Incineration material generated Primary Waste Contractor: Indaver Ireland Disposal/Recovery Site: AVG, Hamburg, For inspection purposes only. Germany. Consent of copyright owner required for any other use. Oily water Defined as - As required As required - - Reporocessing waste waste is Primary Waste generated Contractor: Horizon Environmental Final Disposal/Recovery Rilta Environmental Ltd, Rathcoole, Co. Dublin
Page 210 of 235
EPA Export 29-05-2012:04:39:49
IPPC Application Form V2/12
Waste EWC Code Main source 1 Quantity On-site Recovery Off-site Off-site Disposal material / Disposal Recovery, reuse or recycling Tonnes / M3 / month (Method & (Method, (Method, Location month Location ) Location & & Undertaker) Undertaker) Gases in 160504 - 0.034 0.034 1 - - Disposal – pressure Incineration containers Primary Waste (including Contractor: halons) Indaver Ireland Disposal/Recovery Site: AVG, Hamburg, Germany. Lead 160601 - 0.081 0.081 1 - - Disposal – batteries Incineration Primary Waste Contractor: Indaver Ireland Disposal/Recovery Site: AVG, Hamburg, For inspection purposes only. Germany. Consent of copyright owner required1 for any other use. These 200133 - 0.028 0.028 - - Disposal – batteries Incineration Primary Waste Contractor: Indaver Ireland Disposal/Recovery Site: AVG, Hamburg, Germany.
Page 211 of 235
EPA Export 29-05-2012:04:39:49
IPPC Application Form V2/12
Waste EWC Code Main source 1 Quantity On-site Recovery Off-site Off-site Disposal material / Disposal Recovery, reuse or recycling Tonnes / M3 / month (Method & (Method, (Method, Location month Location ) Location & & Undertaker) Undertaker) Other bases 060205 - 0.022 0.022 1 - - Disposal – Incineration Primary Waste Contractor: Indaver Ireland Disposal/Recovery Site: AVG, Hamburg, Germany. Aqueous 070501 - 0.008 0.008 1 - - Disposal – washing Incineration liquids Primary Waste Contractor: Indaver Ireland Disposal/Recovery Site: AVG, Hamburg, For inspection purposes only. Germany. Consent of copyright owner required1 for any other use. Other 130208 - 0.007 0.007 - - Disposal – engine, gear Incineration and Primary Waste lubricating Contractor: oils Indaver Ireland Disposal/Recovery Site: AVG, Hamburg, Germany.
Page 212 of 235
EPA Export 29-05-2012:04:39:49
IPPC Application Form V2/12
Waste EWC Code Main source 1 Quantity On-site Recovery Off-site Off-site Disposal material / Disposal Recovery, reuse or recycling Tonnes / M3 / month (Method & (Method, (Method, Location month Location ) Location & & Undertaker) Undertaker) Wastes not 130899 - 0.002 0.002 1 - - Disposal – otherwise Incineration specified Primary Waste Contractor: Indaver Ireland Disposal/Recovery Site: AVG, Hamburg, Germany.
1 A reference should be made to the main activity / process for each waste. Note: 1 For these materials the wastes are aqueous and contain water. The assumption has been made that 1 tonne of the aqueous solution is equal to 1m 3. For inspection purposes only. Consent of copyright owner required for any other use.
Page 213 of 235
EPA Export 29-05-2012:04:39:49
IPPC Application Form V2/12
TABLE H.1(ii) WASTE - Other Waste Recovery/Disposal
Waste EWC Code Main source 1 Quantity On-site Off-site Recovery, Off-site Disposal material recovery/dispo reuse or sal2 recycling
Tonnes / m3 / month (Method & (Method, Location (Method, Location month Location) & & Undertaker) Undertaker) Cardboard 150101 Packaging 1.674 1.674 1 - Recycling - Packaging Primary Waste Contractor: Greenstar, Sligo Final Disposal/Recovery Site: Bailey Waste, Dublin (Greenstar) Waste plastic 150102 Packaging 0.443 0.443 1 - Recycling - packaging Primary Waste Contractor: Connaught Waste recycling, Galway For inspection purposes only. Final Consent of copyright owner required for any other use. Disposal/Recovery Site: Connaught Waste recycling, Galway
Page 214 of 235
EPA Export 29-05-2012:04:39:49
IPPC Application Form V2/12
Mixed Dry 150106 Packaging, 0.323 0.323 1 - Recycling - Recyclables office work, Primary Waste canteen Contractor: Greenstar, Sligo Final Disposal/Recovery Site: The Deepwater Quay, Sligo, Ireland. Used Tyvek® 150203 Process As required As required - Recycling - gowns Primary Waste Contractor: Connaught Waste recycling, Galway Final Disposal/Recovery Site: Connaught Waste recycling, Galway General 180203 General waste As required As required - Recycling - waste whose Primary Waste collection and Contractor: disposal is not Greenstar, Sligo subject to For inspection purposes only. Consent of copyright owner required for any other use. special requirements in order to prevent infection
Page 215 of 235
EPA Export 29-05-2012:04:39:49
IPPC Application Form V2/12
Waste office 200101 Office work As required As required - Recycling - Paper Primary Waste Contractor: Connaught Waste recycling, Galway Final Disposal/Recovery Site: Connaught Waste recycling, Galway Glass 200102 - As required As required - Recycling - Primary Waste Contractor: Greenstar, Sligo Final Disposal/Recovery Site: Killagh More, Ballinasloe, Co. Galway Compost 200108 Canteen 0.281 0.281 1 - - - waste Metal 200140 - As required As required - Recycling - Primary Waste For inspection purposes only. Contractor: Consent of copyright owner required for any other use. Galway Metal Recycling, Emerald Salvage & Recycling Ltd. Final Disposal/Recovery Site: Galway Metal Recycling, Emerald Salvage & Recycling Ltd. Bulk Waste 200307 - 2.302 2.302 1 - - -
Page 216 of 235
EPA Export 29-05-2012:04:39:49
IPPC Application Form V2/12
Oily 130503 - - - - Water/Sludge Wooden 191206* Packaging As required As required - Recycling - Pallets Primary Waste Contractor: Greenstar, Sligo Final Disposal/Recovery Site: Greenstar, Sligo Waste 1606 As required As required - Recycling - Batteries Manufacturing Primary Waste QC Contractor: Enva Administratio Ireland n Final Disposal/Recovery Site: Campine Recycling, Beers, Belgium Waste suits, - As required As required - - Disposal - Landfill overshoes, Manufacturing Primary Waste hairnets and Contractor: other non- Greenstar, Sligo hazardous For inspection purposes only. Final Consent of copyright owner required for any other use. wastes from Disposal/Recovery production Site: and the Killaghmore, canteen. Ballinasloe, Co. Galway
Page 217 of 235
EPA Export 29-05-2012:04:39:49
IPPC Application Form V2/12
Mixed 200301 - 3.14 3.14 1 - Recycling - municipal Primary Waste waste Contractor: Greenstar, Sligo Final Disposal/Recovery Site: Greenstar, Sligo Wood other 200138 - 0.053 0.053 1 - Recycling - than Primary Waste mentioned in Contractor: 200137 Greenstar, Sligo Final Disposal/Recovery Site: Greenstar, Sligo Paper and 200101 - 0.713 0.713 1 - Recycling - cardboard Primary Waste Contractor: Connaught Waste Recycling Final Disposal/Recovery For inspection purposes only. Site: Connaught Consent of copyright owner required for any other use. Waste Recycling, Claregalway, Galway, Ireland.
Page 218 of 235
EPA Export 29-05-2012:04:39:49
IPPC Application Form V2/12
Plastic 150102 - 0.443 0.443 1 - Recycling - Packaging Primary Waste Contractor: Connaught Waste Recycling Final Disposal/Recovery Site: Connaught Waste Recycling, Claregalway, Galway, Ireland. Plastics, 200139 - 0.250 0.250 - Recycling - other wastes Primary Waste from Contractor: mechanical Connaught Waste treatment Recycling not Final mentioned in Disposal/Recovery 191211 Site: Connaught Waste Recycling, Claregalway, Galway, Ireland. - 191212 - 0.267 0.267 - Recycling - For inspection purposes only. Primary Waste Consent of copyright owner required for any other use. Contractor: Connaught Waste Recycling Final Disposal/Recovery Site: Connaught Waste Recycling, Claregalway, Galway, Ireland.
Page 219 of 235
EPA Export 29-05-2012:04:39:49
IPPC Application Form V2/12
1 A reference should be made to the main activity/ process for each waste. 2 The method of disposal or recovery should be clearly described and referenced to Attachment H.1 Note: 1 For these materials the wastes are aqueous and contain water. The assumption has been made that 1 tonne of the aqueous solution is equal to 1m 3. 2 S.I. No. 434 of 2011 WASTE MANAGEMENT (LANDFILL LEVY) REGULATIONS 2011 – Conversion factor for Household waste – compacted (includes all bulk disposals) Cubic Metres to tonnes multiply by 0.4. To convert tonnes to cubic metres divide by 0.4.
For inspection purposes only. Consent of copyright owner required for any other use.
Page 220 of 235
EPA Export 29-05-2012:04:39:50
IPPC Application Form V2/12
Table I.2(i) SURFACE WATER QUALITY
(Sheet 1 of 2) Monitoring Point/ Grid Reference: ___ Not Applicable ______
Parameter Results Sampling Normal Analysis method (mg/l) method 2 Analytical / technique (grab, drift etc.) Range 2 Date Date Date Date pH Temperature Electrical conductivity EC Total Ammonia as N Chemical oxygen demand Biochemical oxygen demand Dissolved oxygen DO Orthophosphate as P Nitrate as N Nitrite as N Calcium Ca Cadmium Cd Chromium Cr Chloride Cl For inspection purposes only. Consent of copyright owner required for any other use. Copper Cu Iron Fe Lead Pb Magnesium Mg Manganese Mn Mercury Hg
Page 221 of 235
EPA Export 29-05-2012:04:39:50
IPPC Application Form V2/12
Surface Water Quality (Sheet 2 of 2) Parameter Results Sampling Normal Analysis method (mg/l) method Analytical Range / technique (grab, drift etc.) Date Date Date Date Nickel Ni Potassium K Sodium Na
Sulphate SO 4 Zinc Zn
Total alkalinity (as CaCO 3) Total organic carbon TOC Total oxidised nitrogen TON
Nitrite NO 2 Nitrate NO 3 Faecal coliforms ( /100mls) Total coliforms ( /100mls)
Phosphate PO 4
For inspection purposes only. Consent of copyright owner required for any other use.
Page 222 of 235
EPA Export 29-05-2012:04:39:50
IPPC Application Form V2/12
Table I.4(i) GROUNDWATER QUALITY (Sheet 1 of 2) Monitoring Point/ Grid Reference: ___ Not Applicable ______
Parameter Results Sampling Normal Analysis method (mg/l) method Analytical Range / technique (composite etc.) Date Date Date Date pH Temperature Electrical conductivity EC Total Ammonium as N Nitrite as N Nitrate as N Orthphosphate as P Dissolved oxygen DO Residue on evaporation (180 oC) Aluminium Al Arsenic As Boron B Calcium Ca Cadmium Cd For inspection purposes only. Consent of copyright owner required for any other use. Chromium Cr Chloride Cl Copper Cu Cyanide Cn, total Iron Fe Lead Pb Magnesium Mg Manganese Mn Mercury Hg Nickel Ni
Page 223 of 235
EPA Export 29-05-2012:04:39:50
IPPC Application Form V2/12
Potassium K Sodium Na
Sulphate SO 4
For inspection purposes only. Consent of copyright owner required for any other use.
Page 224 of 235
EPA Export 29-05-2012:04:39:50
IPPC Application Form V2/12
GROUNDWATER QUALITY (SHEET 2 OF 2)
Parameter Results Sampling method Normal Analytical Analysis method (mg/l) (composite, Range / technique dipper etc.) Date Date Date Date
Phosphate PO 4 Sulphate SO 4 Zinc Zn
Total alkalinity (as CaCO 3) Total organic carbon TOC Total oxidised nitrogen TON Arsenic As Barium Ba Boron B Fluoride F Phenol Phosphorus P Selenium Se Silver Ag
Nitrite NO 2 Nitrate NO 3 For inspection purposes only. Consent of copyright owner required for any other use. Faecal coliforms ( /100mls) Total coliforms ( /100mls) Water level (m OD)
Page 225 of 235
EPA Export 29-05-2012:04:39:50
IPPC Application Form V2/12
TABLE I.4(ii): LIST OF OWNERS/FARMERS OF LAND ___ Not Applicable ______
Land Owner Townlands where landspreading Map Fertiliser P requirement for each farm Reference *NMP must take account of on-farm slurry
Total P requirement of the client List ______
TABLE I.4(ii): LANDSPREADING
Land Owner/Farmer______Not Applicable ______
Map Reference______
Field Total (a) Soil Crop P Volume of Estimated P (b) P Applied Total Volume ID Area Usable P Date Required On-Farm in On-Farm Volume to (kg P/ha) of imported (ha) Area Test of P (kg P/ha) Slurry Slurry be Applied slurry per plot (ha) Mg/l test Returned (kg P/ha) (m 3/ha) (m 3) (m 3/ha) For inspection purposes only. Consent of copyright owner required for any other use.
Total volume that can be imported on to the farm:
Concentration of P in landspread material - kg P/m 3
Page 226 of 235
EPA Export 29-05-2012:04:39:50
IPPC Application Form V2/12
Concentration of N in landspread material - kg N/m 3
For inspection purposes only. Consent of copyright owner required for any other use.
Page 227 of 235
EPA Export 29-05-2012:04:39:50
IPPC Application Form V2/12
Table I.7(i): AMBIENT NOISE ASSESSMENT Please refer to Attachment N o F.2 Environmental Noise Measurement, Elanco Animal Healthcare Facility, Finisklin Business Park, Co. Sligo, August 2010 - which presents the requested information below .
Third Octave analysis for noise emissions should be used to determine tonal noises National Grid Sound Pressure Levels Reference
(6N, 6E) L(A) eq L(A) 10 L(A) 90 1. SITE BOUNDARY
Location 1: Location 2: Location 3: Location 4: 2. NOISE SENSITIVE LOCATIONS Location 1: Location 2: Location 3: Location 4: For inspection purposes only. Consent of copyright owner required for any other use. NOTE: All locations should be identified on accompanying drawings.
Page 228 of 235
EPA Export 29-05-2012:04:39:50
IPPC Application Form V2/12
ANNEX 2: CHECKLIST FOR ARTICLE 10 COMPLIANCE
Article 10 of the Environmental Protection Agency (Licensing) Regulations, 1994 to 2010 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, all Applicants should complete the following checklist and submit it with the completed Application Form.
Article 10(2) Section in Checked by Application Applicant (a) give the name, address and telephone number of the applicant and, if different, any address to which correspondence relating to the application should be sent and, if the Section B.1 applicant is a body corporate, the address of its registered or principal office,
(b) give - (i) in the case of an established activity, the number of employees and other persons working or engaged in connection with the activity on the date after which a licence is required and during normal levels of operation, or Section B.4
(ii) in any other case, the gross capital cost of the activity to which the application relates,
(c) give the name of the planning authority in whose functional area the activity is or will be carried on, Section B.5
(d) in the case of a discharge of any trade effluent For or inspection other purposes matter only. (other than domestic sewage or storm water) to a sewer of a WaterConsent Servicof copyrightes owner Authority, required for any give other use. the name of the Section B.6 Water Services Authority in which the sewer is vested or by which it is controlled,
(e) give the location or postal address (including where appropriate, the name of the relevant townland or townlands) and the National Grid reference of the premises to which the Section B.2 activity relates,
(f) specify the relevant class or classes in the First Schedule to the Act to which the activity relates, Section B.3
(g) specify the raw and ancillary materials, substances, preparations, fuels and energy which Section G
Page 229 of 235
EPA Export 29-05-2012:04:39:50
IPPC Application Form V2/12
will be produced by or utilised in the activity,
(h) describe the plant, methods, processes, ancillary processes, abatement, recovery and Section D.1 treatment systems, and operating procedures for the activity,
For inspection purposes only. Consent of copyright owner required for any other use.
Page 230 of 235
EPA Export 29-05-2012:04:39:50
IPPC Application Form V2/12
Article 10(2) continued../ Section in Checked by Application Applicant (i) indicate how the requirements of section 83(5)(a)(i) to (v) and (vii) to (x) of the Act shall be met, having regard, where appropriate, to any relevant specification issued by the Agency under section 5(3) of the Act and the reasons for the selection of the arrangements Section L proposed,
(j) give particulars of the source, nature, composition, temperature, volume, level, rate, method of treatment and location of emissions, and the period or periods during which the Section E emissions are made or are to be made,
(k) describe the arrangements for the prevention or minimisation of waste and, where waste is produced, the on and of site arrangements for the recovery or disposal of solid and liquid Section H.2 wastes,
(l) specify, by reference to the relevant European Waste Catalogue codes as prescribed by Section I.6 Council Directive 98/2008/EC of 19 November 2008, the quantity and nature of the waste and Tables or wastes produced or to be produced by the activity, H.1(i) and H.1 (ii) (m) provide: (i) details, and an assessment, of the impacts of any existing or proposed emissions on the environment, including on an environmental medium other than that or those into which the emissions are or are to be made, and For inspection purposes only. Section I Consent of copyright owner required for any other use. (ii) details of the proposed measures to prevent or eliminate, or where that is not practicable, to limit, reduce or abate emissions,
(n) identify monitoring and sampling points and outline proposals for monitoring emissions and the environmental consequences of any such emissions, Section F
(o) describe the condition of the site of the installation, Section D
(p) describe in outline the main alternatives, if any, to the proposals contained in the Section I.8 application which were studied by the applicant,
Page 231 of 235
EPA Export 29-05-2012:04:39:50
IPPC Application Form V2/12
(q) specify the measures to be taken to comply with an environmental quality standard where such a standard requires stricter conditions to be attached to a licence than would otherwise Not Not be determined by reference to best available techniques, applicable applicable
Article 10(2) continued../ Section in Checked by Application Applicant (r) describe the measures to be taken for minimising pollution over long distances or in the territory of other states, Section I
(s) describe the measures to be taken under abnormal operating conditions, including start-up, Section J shutdown, leaks, malfunctions, breakdowns and momentary stoppages, and Section E (t) describe the measures to be taken on and following the permanent cessation of the activity or part of the activity to avoid any risk of environmental pollution and to return the site of Section K the activity to a satisfactory state,
(u) describe, in the case of an activity which gives, or could give rise, to an emission containing a hazardous substance which is discharged to an aquifer and is specified in the Annex to Council Directive 80/68/EEC of 17 December 1979 on the protection of groundwater against Not Not pollution caused by certain dangerous substances, the arrangements necessary to comply applicable applicable with said Council Directive,
(v) include any other information required under Ar ticle For inspection 6(1) purposesof Council only. Directive 2008/1/EC of Information Consent of copyright owner required for any other use. 15 January 2008 concerning integrated pollution prevention and control, provided throughout the application (w) include a non-technical summary of information provided in relation to the matters specified Section A in paragraphs (f) to (v) above, (x) state whether the activity consists of, comprises, or is for the purposes an establishment to which the European Communities (Control of Major Accident Hazards involving Dangerous Not Not Substances) Regulations, 2006(S.I. No. 74 of 2006) apply, applicable applicable
Page 232 of 235
EPA Export 29-05-2012:04:39:50
IPPC Application Form V2/12
Article 10(3) Section in Checked by Without prejudice to Article 12(1), an application for a licence shall be accompanied by - Application Applicant
(a) a copy of the relevant page of the newspaper in which the notice in accordance with article Attachment 6 has been published, B.8
(b) a copy of the text of the site notice erected or fixed on the land or structure in accordance Attachment with article 7, B.8
(c) a copy of the notice given to the planning authority under section 85(1)(a) of the Act, Attachment B.8 (d) a copy of such plans, including a site plan and location map (no larger than A3), and such other particulars, reports and supporting documentation as are necessary to identify and describe - Attachment A
(i) the activity Attachment A Application Form Map 2 and Application Form Map 3 (ii) the position of the site notice in accordance with For inspection article purposes 7, only. Attachment A Consent of copyright owner required for any other use. Application Form Drawing 11 (iii) the point or points from which emissions are made or are to be made, and Attachment A Application Form Drawings 4, 5 and 6
Page 233 of 235
EPA Export 29-05-2012:04:39:50
IPPC Application Form V2/12
(iv) monitoring and sampling points, and Attachment A Application Form Drawings 4, 5 and 6 (e) a fee specified in accordance with section 94 of the Act. Accompanying cheque
For inspection purposes only. Consent of copyright owner required for any other use.
Page 234 of 235
EPA Export 29-05-2012:04:39:50
IPPC Application Form V2/12
Article 10(4) Checked by Applicant (b) A signed original and 2 hardcopies of the application and accompanying documents/particulars in hardcopy format plus 2 copies of all files in electronic searchable PDF format on CD-Rom shall be submitted to the headquarters of the Agency.
In cases where an E.I.S. is required to be submitted to the Agency in support of the application, a signed original and 2 hardcopies of the EIS plus 16* copies of all files in electronic searchable PDF format on CD- Rom shall be submitted to the headquarters of the Agency.
* Energy sector applicants = 18 copies
Hardcopies submitted. 2
CD version submitted. 2
For inspection purposes only. Consent of copyright owner required for any other use.
Page 235 of 235
EPA Export 29-05-2012:04:39:50