Attachment 7.1.3.2 Impact Assessment of Emissions ...Agency’s (EPA) Licence Application Form Guidance – Industrial Emissions (IE), Integrated Pollution Control (IPC) and Waste

Regeneron IE Licence Review Application LA001739 AWN Consulting Limited _____________________________________________________________________________________________________

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Attachment 7.1.3.2 - Page 1

Attachment 7.1.3.2 – Impact Assessment of Emissions/Discharges 1.0 INTRODUCTION

AWN Consulting Ltd. (AWN) was appointed by Jacobs Engineering on behalf of Regeneron Ireland to complete a Receiving Environment Report for their existing Industrial Emissions (IE) licensed installation in Raheen, Co. Limerick. This report is to accompany an application for a new IE licence.

This report was completed in accordance with the Environmental Protection Agency’s (EPA) Licence Application Form Guidance – Industrial Emissions (IE), Integrated Pollution Control (IPC) and Waste.

1.1 Description of Site

The Regeneron site is located within an established industrial park in Raheen, Limerick approximately 5km south-west of Limerick City centre. The site has a number of access roads to the west, south-west and south-east. A number of industrial buildings are situated to the south, north and east with some agricultural and green-field sites to the west. The location of the installation is shown on Drawing 002. The purpose of this installation is the bulk production of bio-pharmaceutical divided medical products for patients worldwide, together with associated business support functions. This includes central production, cleanrooms, warehousing, clean water, and stream utilities including boilers, heating ventilation and air conditioning systems, and electrical switch rooms. A Quality Control laboratory for quality control test procedures related to the manufacturing process is also included within the built site. The project will consist of an extension to the east of the existing manufacturing building (the ‘east expansion’) to allow for additional production trains, an Administration and Laboratories Building (ALB), a multi storey carpark (MSCP), and an extension of the existing carpark to the west of the current main manufacturing building.

1.2 Limitations of the Report

The conclusions presented in this report are professional opinions based solely on the tasks outlined herein and the information made available to AWN. They are intended for the purpose outlined herein and for the indicated site and project. Furthermore, this report is produced solely for the benefit of Jacobs Engineering on behalf of Regeneron Ireland to address an Environmental Protection Agency (EPA) requirement for their licence.

This report may not be relied upon by any other party without explicit agreement

from AWN. Opinions and recommendations presented herein apply to the site conditions existing at the time of the recently completed field work and subsequent assessment. They cannot apply to changes at the site of which AWN is not aware and has not had the opportunity to evaluate. This report is

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intended for use in its entirety; no excerpt may be taken to be representative of this assessment. All work carried out in preparing this report has utilized and is based on AWN professional knowledge and understanding of the current relevant Irish and European Community standards, codes and legislation.

2.0 IMPACT TO SURFACE WATER 2.1 Surface Water Environment

The proposed development site is located within the Shannon International River Basin District (SIRBD) in Hydrometric Area No. 24 of the Irish River Network. The First Cycle Shannon River Management Plan (2009-2015) is to be superseded by Second Cycle River Basin Management Plan (2018-2021) and has recently completed public consultation in August 2017. The new River Basin Management Plan defines a single national river basin district. This has been broken down into 46 catchment management units, which are further sub-divided into 583 sub-catchments. These 583 sub-catchments contain a total of 4,832 water bodies ranging from 3 to 15 water bodies in each sub-catchment. The Shannon River Management Plan defines that the area of the proposed development is within the Maigue catchment and the Ballynaclough sub-catchment. This may change once the second cycle management plan is approved. The River Shannon is located approximately 4km northwest of the installation with the Lower River Shannon Tributary approximately 3km to the northeast of the installation. The Limerick City & Environs Municipal WWTP located in Bunlicky, which will receive and treat waste water from Regeneron site, discharges treated effluent within the tidal reach of the River Shannon at the eastern limit of Limerick City within both the Lower River Shannon cSAC and the River Shannon and River Fergus Estuaries SPA. The EPA online mapping data (Envision) indicates that for the period 2010 to 2015 the water quality in this transitional estuarine reach of the River Shannon into which the WWTP discharges is of “moderate” status. The closest surface water feature to the installation is Barnakyle River, which skirts the southern end of Raheen Business Park. The Barnakyle River is a tributary of the River Maigue which flows into the River Shannon approximately 10km west of Limerick City. There are no natural watercourses occurring within the proposed development site.

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Figure 1 Hydrological Environment Map (source www.gsi.ie, 2018)

2.1.1 Ecologically Designated Sites

The Geological Society of Ireland (GSI) and National Parks and Wildlife Service (NPWS) on-line databases presently list no ecological designated areas within or immediately adjacent to the proposed development site. The Lower River Shannon SAC (Site Code: 002165) and the River Shannon and River Fergus Estuaries SPA (Site Code: 004077) are c.4.0km away. An Appropriate Assessment Screening report was completed for both the east expansion development and the ALB and MSCP development as part of the requirements for the respective planning applications. These are provided with Section 6 of this licence review application. A Natura Impact Statement (NIS) was also completed for the ALB and MSCP development as the screening report concluded that it was not possible to exclude the likely significant effects of that development on the aforementioned European sites. An NIS was therefore required. The NIS concluded that: ‘It is the considered view of the authors of this NIS (Scott Cawley Ltd.) that, following the implementation of the mitigation measures prescribed in Section 7 (the effectiveness of which is also set out in Section 7), the proposed development will not, by itself or in combination with other plans or projects, have an adverse effect on the integrity of any European sites in view of their

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conservation objectives and there is no reasonable scientific doubt as to that conclusion.’ (Scott Cawley Ltd., 2018; page 3). A copy of the NIS is also provided in Section 6 of this licence review application.

2.1.2 Regional Surface Water Quality

The proposed development is located within the Shannon International River Basin District (SIRBD), as defined under the European Communities Directive 2000/60/EC, establishing a framework for community action in the field of water policy – this is commonly known as the Water Framework Directive (WFD). The WFD requires ‘Good Water Status’ for all European waters to be achieved by 2015 through a system of river basin management planning and extensive monitoring. ‘Good status’ means both ‘Good Ecological Status’ and ‘Good Chemical Status’. In 2009 the SIRBD River Management Plan (RMP) 2009-2015 was published. In the SIRBD RMP, the impacts of a range of pressures were assessed including diffuse and point pollution, water abstraction and morphological pressures (e.g. water regulation structures). The purpose of this exercise was to identify water bodies at risk of failing to meet the objectives of the WFD by 2015 and include a programme of measures to address and alleviate these pressures by 2015. The SIRBD is to be replaced by the River Basin Management Plan (2018-2021). The strategies and objectives of the WFD in Ireland have influenced a range of national legislation and regulations. These include the following: o Statutory Instrument (SI) No. 293 of 1988 European Communities

(Quality of Salmonid Waters) Regulations 1988; o Local Government (Water Pollution) Acts 1977-1990; o SI No. 258 of 1988 Water Quality Standards for Phosphorus Regulations

1998; o SI No. 272 of 2009 European Communities Environmental Objectives

(Surface Waters) Regulations 2009; and o SI No. 386 of 2015, European Communities Surface Water Regulations

(Amendment). In accordance with the WFD, each river catchment within the SIRBD was assessed and a water management plan detailing the programme of measures was put in place for each. For the purpose of this assessment the Barnakyle River was assessed. Q-Values are used by the EPA to express biological water quality, based on changes in the macro invertebrate communities of riffle areas brought about by organic pollution. Table 1 below summarises an explanation of the ratings; for example, Q1 indicates a seriously polluted water body while Q5 indicates unpolluted water of high quality. Table 1 also indicates the key used by the EPA mapping format to indicate quality status.

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Quality Ratings (Q) Status Water Quality Key

Q5, Q4-5 High Unpolluted

Q4 Good Unpolluted

Q3-4 Moderate Slightly Polluted

Q3, Q2-3 Poor Moderately Polluted

Q2, Q1-2, Q1 Bad Seriously Polluted

Table 1 EPA Biological Q Ratings & Key

Entity Name BARNAKYLE

Station Name: Doneen Br Br SE of Clarina Br SW of Kilpeacon

Crossroads

Station ID: RS24B050400 RS24B050600 RS24B050300

WFD CODE: IE_SH_24B050600 IE_SH_24B050600 IE_SH_24B050300

Type of water monitored: River Water River Water

River Water

River Basin District: SIRBD SIRBD SIRBD

Station Type (WFD): Operational Operational Operational

Easting: 155257 151076 156258

Northing: 149914 153043 147710

Last Q Year: 2003 2014 2014

Last Q Value: 3-4 3 3

Q Legend: Moderate Poor Poor

Q Linear Value: 3-4 3 3

Table 2 EPA sampling locations for the Barnakyle River

Available data from the EPA on-line mapping database is presented in Table 2 together with the most recent Q-Value for the watercourse at the locations closest to the site. Figure 2 presents the river catchment map and water quality status (including current EPA monitoring stations).

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Figure 2 River Catchment Map & Quality (EPA Online Mapping, accessed 2018).

The values listed above are for monitoring stations located both upstream and downstream of the subject site. As shown on Figure 2 the downstream monitoring location (RS24B050600) has a Q Linear Value of 3 (‘Poor Status’) this is similar to the upstream monitoring location (RS24B050300) which also has a Q Linear Value of 3 (‘Poor Status’). The overall recorded status of the river Barnakyle is Poor. The Barnakyle River is classified as being ‘at risk of not achieving good status’. In accordance with the WFD, each river catchment within the SIRBD was assessed and a water management plan detailing the programme of measures was put in place for each. For the Maigue WMU (Water Management Unit) the main pressure preventing achievement of ‘Good Status’ is diffuse agricultural pollution. Full implementation of the Maigue WMU Action Plan is expected to correct this; however, it is estimated that the Barnakyle River will not achieve ‘Good’ status until 2021. EPA’s Envision Database was also consulted to determine if any designated salmonid waters (S.I. 293/1988-European Communities (Quality of Salmonid Waters) Regulations, 1988) existed close to the site or are located so that they may be adversely impacted by the proposed development or operation of the

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installation. The Barnakyle River was previously not included in the register of salmonid waters included in those regulations.

2.1.3 Flooding

In accordance with the guidelines produced by the Department of the Environment, Heritage and Local Government (DoEHLG) - The Planning System and Flood Risk Management (FRM) Guidelines for Planning Authorities, November 2009, a Stage 1 assessment was carried out and is submitted as part of the planning application for the east expansion development (Planning Reference 17/1170) with an additional Stage 1 assessment carried out for inclusion with the planning application for the proposed ALB and MSCP development (Planning Reference 18/1098). The purpose of these assessments was to identify whether there may be any flooding or surface water management issues related to the proposed developments that may warrant further investigation. The result of both assessments was that there is no significant risk of flooding at the site. Flooding was also considered for the receiving environment, the Barnakyle River, which flows from the south of the site in a north east direction towards the Maigue River. Under the OPW’s online National Flood Hazard Mapping (http://www.floodmaps.ie) the only recorded downstream flood event was at the Maigue Embankments Sept 1992. The OPW flood mapping (www.floodinfo.ie) application also showed that the Barnakyle River was not at high risk of flooding into its flood plain. The 1 in 10-year event is likely to be contained within the existing banks (with the exception of the area around Cloughkeating).

2.2 Emissions to Stormwater Details of the stormwater drainage network and stormwater emission points are presented in Attachment 4.8.1 (Operational Report). In accordance with BAT, clean stormwater is kept separate from process wastewater and there is no inherent risk of cross-contamination.

2.3 Potential Impacts to Surface Water Environment 2.3.1 Management of Fuels, Chemicals and Wastes

A full list of chemicals and their hazard statements is compiled and is presented in Attachment 4-6-2 in Section 4 of this IE licence application. Wastes from the installation consist predominantly of solid wastes including spent single use bags, filters, tubes, etc., which may require (i.e. if they have been in contact with biological material) decontamination in the decon autoclave prior to being removed offsite for treatment in a waste to energy facility. These are autoclaved within the installation and are stored in the Waste Management Yard prior to collection. Certain lab chemicals and liquid wastes not suitable for discharge to the sewer will be collected in suitable plastic drums, labelled as hazardous waste, and

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transferred to the designated self-bunded chemstores in the Waste Management Yard. The majority of the chemicals stored onsite are small in volume and are held in drums, bottles, and / or IBCs within the Warehouse or the external self-bunded chemstores. Bulk storage of chemicals including diesel, process gases (N2, CO2 and O2), 20% ethanol, acid and caustic CIP chemicals, acid and caustic wastewater balancing chemicals (Wastewater Management System), Chemiox (Wastewater Management System), and Nalco 93033 are in bunded and / or in double skinned tanks. There is no additional external bulk tank chemical storage proposed as part of the proposed developments, with the exception of a new Liquid Nitrogen tank in the ALB yard. Apart from diesel fuel and to some smaller extent Nalco cooling water chemicals, Regeneron do not store large quantities of hazardous to the environment chemicals onsite. Table 3 presents the amounts of Nalco and diesel stored (or to be stored) on site. Other small quantities of environmentally hazardous chemicals are also stored in the lab and production areas as presented in the Soil & Groundwater Baseline (Attachment 4.8.3).

Name Storage Container

Storage Area

Relevant Hazard

Statements

Amount

Stored Unit

Diesel

Bulk tanks, mobile

generator tank (Future

only), and pump

house tanks

South Utilities Yard

Wastewater Management System

(Future only)

H411 53,500 Litres

Nalco 93033 - Cooling water

treatment

750L Tank + 200L drums (North Utilities

Yard)

200L drums in ALB yard, WMA and East

Expansion yard

North Utilities Yard (chemstore adjacent to

cooling towers)

Wastewater Management System

(chemstore)

ALB yard (chemstore)

East Expansion yard (chemstore)

H400, H410 2,056 Litres

Nalco 3DT426 - Cooling water

treatment

200L drums

WWTP (chemstore)

North Utilities Yard (adjacent to cooling

towers)

H411 492 Litres

Nalco 73500 - BIOCIDE

25L drums

WWTP (chemstore)

North Utilities Yard (adjacent to cooling

towers)

H412 25 Litres

Table 3 Hazardous Materials and Corresponding Hazard Statements

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Diesel fuel oil is stored in 2 No. above ground bulk oil tanks as well 2 No. sprinkler diesel tanks. Cira 53,500 litres will be stored on the Regeneron site with c. 50,000L in the 2 no. bulk tanks. The bulk tanks are stored in the generator tank farm area which is bunded to a capacity of 105.21m3. The bund where bulk diesel is stored has passed the most recent visual inspection by the structural engineer on 24th October 2017 with the next test scheduled in 2020. The surrounding area and in particular the loading area are concrete hardstand to avoid any direct discharge to ground, and there are 2 no. 10,000L Class 1 full retention interceptors installed on the drainage lines from these areas. The smaller diesel tanks at the pump house and in 2019 the mobile generator proposed for the Wastewater Management System will be double skinned and any leak in the tank would be fully contained. These tanks are / will be stored on hardstand yard areas to avoid any direct discharge to ground. Whilst these tanks are not bunded, any spillage of diesel during use would either be cleaned up using spills kits or as a worst case be directed to the stormwater drainage network which includes a c. 37,000L Class 1 by-pass petrol interceptor. Nalco 93033 is mainly stored in drums within the self-bunded chemstores. There is also a 750L tank at the self-bunded chemstore in the North Utilities yard. The surrounding area and in particular the loading area are continuous concrete hardstand to avoid any direct discharge to ground. All process materials, product and chemicals will be delivered to the site in tamper proof and/or lockable containers or tankers, which are approved for transport use. Deliveries will be supervised, and any spill will be addressed using designated spill kits by trained personnel. Spill kits are located across the site in highly visible and mobile units. These include absorbent socks, mats, pads, disposable bags, and PPE.

Drainage from the unloading area for the diesel delivery trucks and the transfer area for the wastewater tanker will also be inspected and diverted for collection and safe disposal if required. All tanks, bunded storage and pipelines have been designed for their specific purpose and their contents and are rendered impervious to the materials stored therein. All tanks and pipelines are subject to a preventative maintenance programme and regular inspection. Tanks will be stored in bunds meeting the requirements of Agency guidelines on the “Storage and Transfer of Materials for Scheduled Activities”. Details of the bunds are provided in Attachment 4.8.1 Operational Report. All bunds are capable of containing 110% of the volume of the largest drum/tank within the bund or 25 % of the total volume of the substance stored and will designed in accordance with the EPA’s guidelines for the storage and transfer of materials for scheduled activities. All concrete bunds are integrity tested every three years in accordance with the requirements of the IE licence. In the event of a spillage, drainage from bunded areas shall be inspected and diverted for collection and safe disposal if required.

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As such, it is very unlikely that any of the chemicals stored onsite will become entrained in the stormwater run-off. Any hydrocarbons and sediment from road run-off will also be managed through the use of the hydrocarbon interceptors and silt traps as described in Attachment 4.8.1.

2.3.2 Management of Flooding The stormwater strategy for site looks to replicate as closely as possible the natural drainage from a site before development. Introduction of new impermeable areas (covering the ALB, MSCP and access roads) will increase surface water runoff from site increasing flood risk to site and/or somewhere else. Attenuation is required in order to retain water within the development site during periods when storm water runoff rates from the site exceed the allowable discharge rate (4L/s). This will protect the development site against flooding and the surface water network, downstream watercourses, and groundwater from detrimental impact.

There are no existing issues with flooding recorded at the site. The proposed increase in hardstand will be mitigated by the proposed upgrades to the drainage network. As such, it is not anticipated that the proposed development will cause an increase in flooding at the site.

2.3.3 Stormwater Monitoring

Continuous monitoring of pH, flow and temperature is in place for discharges of stormwater at SW-1. Regeneron also take a 24-hour composite sample with one sample per week analysed for COD. It is proposed that this sampling frequency be reduced to monthly as part of this licence review. Weekly visual inspections will be undertaken for all stormwater discharge points in accordance with the IE Licence. As outlined in Attachment 4.8.1 there is a pH-controlled penstock in place at SW-1 which allows the discharge to be cut off should any contamination be noted. This also closes automatically on sprinkler activation and can be closed manually at the unit. An additional pH-controlled penstock is also proposed for the drainage from the new attenuation tank (for the ALB and car park areas) prior to connecting to the existing site drainage network; this is for best practice only and will not be included in the IE licence monitoring requirements. As such, there are stringent controls in place to ensure that in the unlikely event that stormwater becomes contaminated it will be prevented from discharging off the site and into the storm sewer (or the engineered peculation area).

2.3.4 Impact to Surface Water Environment

Based on this assessment, the proposed development will not have a significant impact on the quality of the receiving surface water bodies as further discussed in

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Attachment 7.1.3.3 Receiving Environment Report. There is a very low risk of Principle Pollution Substances being discharged from the installation via the stormwater network due to the stringent controls and procedures in place to prevent and minimize spills. The proposed development will also not have a significant impact on the hydrology of the area and new SUDs measures have been incorporated to reduce the uncontrolled flow rate from the site.

3.0 IMPACT TO SEWER

3.1 Emissions to Sewer 3.1.1 Industrial Wastewater Discharges

Industrial wastewater from both the existing and proposed developments can be divided into the following types: - Biological waste from upstream process areas requiring heat inactivation; - Other process wastewaters from cell free unit operations, production support

areas, and chemically inactivated bio-waste & utility waste from the labs in the QC and ALB;

- Utilities wastewater including cooling tower blow down, boiler blow down, softener back washers and WFI sanitisation water, chilled water;

The licensed emissions to sewer from the current installation are up to 1,500m³ of wastewater per day. High level discussions with Irish Water have had regarding an increased wastewater discharge into the municipal network of up to a maximum of 3,600m³ per day subject to agreement with the EPA under the terms of the facilities IE Licence.

The main characteristics of the wastewater as proposed are presented in Table 4.

Description Max values per day (kg unless otherwise noted)

Max Concentration Per Hour (mg/l unless otherwise stated)

Flow 3,600 (m3/day) 150 m3

BOD 4,680 1,300

COD 7,920 2,200

Suspended Solids 2,700 750

Total Phosphorous 360 100

Total Kjeldahl Nitrogen 684 190

Sulphate 2,200 600

Table 4 Wastewater Characteristics

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It is not anticipated that any significant concentrations of List I or List II substances, as listed in the Annex to European Union (EU) Directive 2006/11/EC (as amended) will be contained in any emission to sewer from the site.

3.1.2 Domestic Wastewater

Wastewater from welfare facilities and the canteen will join with the treated wastewater and discharge to the public sewer at a point after SE-1. This will be within the prescribed flow velocities range of 0.8 – 3.0 m/s as outlined in the Department of the Environment and Local Government document ‘Recommendations for Site Development Works for Housing Areas’.

3.2 Potential Impacts to Sewer

3.2.1 Industrial Wastewater Abatement

Process effluent generated in the main manufacturing operations may contain GMOs and therefore must undergo treatment to deactivate the cell culture. All other process wastewaters including the decontaminated effluent will also require treatment in the Wastewater Management System prior to discharge.

Further details of these abatement systems are provided in Attachment 4.8.1. 3.2.2 Wastewater Monitoring

Regeneron currently monitors the quality of wastewater discharged to sewer along the north western boundary via SE-1 in line with its IE Licence requirements, monitoring the performance of its effluent for pH, flow and temperature with a continuous monitoring system. BOD, COD, suspended solids, TKN, total phosphorus and sulphate are monitored monthly. If exceedances are noted in continuous monitoring it would automatically stop the discharge. There has been no result in breach of Regeneron’s licence requirement since operations began in 2015.

3.2.3 Off-site Waste Water Treatment

The existing wastewater treatment works at Limerick City and Envrions Wastewater Treatment Plant (WWTP) at Bunlicky, Co. Limerick, has a capacity of 130,000 population equivalent (PE) and is currently receiving and treating a daily load of approximately 128,274 PE according to the 2017 AER. The Bunlicky WWTP has been in compliance with its ELVs (BOD, COD, TSS, Ortho P, and pH) for the past 5 years, as presented in the installation’s Annual Environmental Reports (AERs), and there are no current known restraints on the capacity of this plant.

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3.2.4 Impact to Sewer

Operation of the plant will be according to BAT principles and in compliance with the licence conditions to ensure that inputs to, and subsequent contamination of, soil and water environments does not occur during normal and / or emergency conditions (material spillage or fire event situations). Wastewater will be discharged after flow balancing and pH neutralisation to ensure no impacts on the sewer network. Irish Water have advised during high level discussions that the receiving wastewater treatment plant should have the capacity to accept the proposed discharge following a number of suggested revisions which were incorporated into the proposal. S.I. No. 283/2013 - Environmental Protection Agency (Integrated Pollution Control) (Licensing) Regulations 2013, lists a number of Principle Pollution Substance including:

• Substances which contribute to eutrophication (in particular, nitrates and phosphates).

• Substances which have an unfavourable influence on the oxygen balance (and can be measured using parameters such as Biochemical Oxygen Demand (BOD), Chemical Oxygen Demand (COD), etc.).

As such, these parameters will be monitored in accordance with the licence conditions. Mitigation measures were included in the design of the installation to limit the contributions of these parameters as discussed in the BAT Conclusions document for wastewater and waste gas (Attachment 4.7.1). Other Principle Pollution Substances such as heavy metals are not relevant for this installation as there will be no direct contributions of metals to the wastewater streams. Trace quantities from cleaning of metal equipment may be present in the wastewater only. Wastewater to be discharged is relatively low strength and has similar characteristics to domestic wastewater. The loading associated with the proposed discharge, as a percentage of Bunlicky WWTP is insignificant when compared with the overall plant loading. Table 5 shows the percentage of the total influent to the WWTP based on the 2017 AER.

Description Proposed Discharge (Daily Max)

Proposed Discharge (Annual

Mean)

Quantity of Influent to

Limerick City (2017 Total)

Percentage of Limerick City Influent

Max wastewater flow per day (m3 / day)

3,600 986,000 17,319,170 5.69 %

Table 5 Regeneron wastewater as a % of overall influent to Limerick City & Environs WWTP

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The impact on the receiving environment is discussed in Attachment 7.1.3.3 Receiving Environment.

4.0 IMPACT TO AIR 4.1 Air Emissions

4.1.1 Major (Boiler) Air Emissions

The primary air emissions from the installation will be from the existing 5 no. natural gas fired steam boilers, 2 no. natural gas LPHW boilers, and 2 no. new natural gas steam boilers. Further details of these emissions can be found in Attachment 4.8.1. The locations of these boilers are shown on Drawing no. 005.

4.1.2 Minor and Potential Emissions

Minor emissions consist of predominantly process ventilation emissions containing trace levels of contaminants (trace CO2, particulates, solvents, and biologicals). Additional emission points for the ALB and the east expansion have been included in Attachment 7.4.2. and follow the same types of emissions as the existing installation. There are also a number of natural gas fired boilers in the QC lab and the ALB. As these are below 1MW they have been designated as minor emissions and require no abatement or monitoring. Potential emissions include relief valves on the clean steam generators and large steam boilers (steam emissions), chiller relief vents (trace refrigerant emissions), storage tank relief vents (CO2, N2 or O2 emissions from gas tanks, trace ethanol from the ethanol tank), relief valves on the autoclaves (steam emissions), and burner control vents on the steam boilers (natural gas emissions – previously classed as a minor emission). These emissions only occur during abnormal events, for example over-pressurisation. There are 5 no. emergency diesel generators and 2 no. diesel powered fire pumps listed as potential emissions as these will only be used in the case of emergencies. The locations of minor and potential emissions are shown on Drawings 006 and 007.

4.1.3 Fugitive Emissions Anticipated fugitive emissions from the installation will result from the use of solvents for the decontamination of work surfaces. IPA in pre-wetted wipes and sprayed from canister and squirt bottles will be used for cleaning internally. Losses due to displacement of vapour and dilution are anticipated internally within the production areas and laboratories.

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Other uses of solvent in the installation including ethanol for use in the chromatography columns and Acetic Acid and 2-Propanol for use in solution prep are not anticipated to cause fugitive emissions. These chemicals are stored in sealed containers and will be dispensed directly from the container to the point of use in an air-controlled environment.

4.2 Impact on Air Quality

There is the potential for a number of emissions to the atmosphere during the operational phase of the development. In particular, boiler related air emissions may generate quantities of air pollutants such as NO2. Oxides of nitrogen are listed as a Principle Pollution Substance (S.I. No. 283/2013) and as such these have been modelled to assess the impact. The air model report is provided in Appendix A of this attachment.

4.2.1 NO2 Modelling and Boiler Emissions The purpose of the modelling study was to determine whether the emissions from the site will lead to ambient concentrations which are in compliance with the relevant ambient air quality standards for NO2.

Air dispersion modelling was carried out using the United States Environmental Protection Agency’s regulatory model AERMOD (Version 16216r) and the report is provided as Appendix A to this attachment. The air dispersion modelling input data consisted of information on the physical environment (including building dimensions and terrain features), design details from all emission points on-site and five full years of appropriate meteorological data. Using this input data, the model predicted ambient ground level concentrations beyond the site boundary for each hour of the modelled meteorological year. The model post-processed the data to identify the location and maximum of the worst-case ground level concentration. This worst-case concentration was then added to the background concentration to give the worst-case predicted environmental concentration (PEC). The PEC was then compared with the relevant ambient air quality standard to assess the significance of the releases from the site. Throughout this study a worst-case approach was taken. This will most likely lead to an over-estimation of the levels that will arise in practice. The worst-case assumptions are outlined below:

• Maximum predicted concentrations were reported in this study, even if no residential receptors were near the location of this maximum;

• The effects of building downwash, due to on-site buildings, has been included in the model;

• Emission points were assumed to run continuously, every hour of the day, 365 days per year.

In order to reduce the risk to health from poor air quality, national and European statutory bodies have set limit values in ambient air for a range of air pollutants. These limit values or “Air Quality Standards” are health- or environmental-based levels for which additional factors may be considered. Air quality significance criteria are assessed on the basis of compliance with the appropriate standards

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or limit values. The applicable standards in Ireland include the Air Quality Standards Regulations 2011, which incorporate EU Directive 2008/50/EC which combines the previous air quality framework and subsequent daughter directives (see Table 4.1). Although the EU Air Quality Limit Values are the basis of legislation, other thresholds outlined by the EU Directives are used which are triggers for particular actions. The ambient air quality standards applicable for NO2 are outlined in Directive 2008/50/EC (see Table 6). These standards have been used in the current assessment to determine the potential impact of NO2 emissions from the installation on air quality.

Note 1 EU 2008/50/EC – Clean Air For Europe (CAFÉ) Directive replaces the previous Air Framework Directive (1996/30/EC) and daughter directives 1999/30/EC and 2000/69/EC

Table 6 Air Quality Standards Regulations 2011 (Based on Directive 2008/50/EC and S.I. 180 of 2011)

The results indicate that the ambient ground level concentrations of nitrogen oxides (as NO2) are below the annual and 1-hour ambient air quality standards. Emissions from the installation lead to an ambient NO2 concentration (including background) which is 55% of the maximum 1-hour limit (measured as a 99.8th percentile) and 63% of the annual limit at the worst-case off-site location for the worst-case years modelled (2017 and 2014 respectively). Ambient levels of nitrogen oxides (as NO2) from the installation are well below the air quality limit values for the protection of human health and it is predicted that air emissions from the installation will not have a significant impact on the local environment.

4.2.2 Impact from Minor Process Emissions

New minor emissions from preparatory and production vessels, emissions from fume hoods, autoclave vents, production room vents, and low pressure hot water boilers are not considered to be significant and appropriate abatement (i.e. HEPA filters and 2 um filters as appropriate) will be employed to remove trace contaminants.

Pollutant Regulation Note 1 Limit Type Value

Nitrogen Dioxide (NO2)

2008/50/EC

Hourly limit for protection of human health - not to be exceeded more than 18 times/year

200 μg/m3 NO2

Annual limit for protection of human health

40 μg/m3 NO2

Critical level for the protection of vegetation

30 μg/m3 NO + NO2

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4.2.3 Impact from Potential Emissions – Process Emissions

By their nature these emissions are limited to abnormal events, for example over-pressurisation. The emissions are trace levels requiring no abatement.

4.2.4 Impact from Potential Emissions – Emergency Generators

The diesel generator will provide emergency power to critical and essential manufacturing and utility equipment and systems. Emissions of NOx, SOx and particulate matter from the emergency generator will be inconsequential as the generator is small in size and will normally only be used during very short duration for testing, approximately 1-2 hours every month, not exceeded 18 hours in any one year.

4.2.5 Fugitive Emissions

Fugitive emissions from the use of Isopropyl Alcohol (IPA) impregnated wipes and spray for cleaning internal work surfaces will be minor in nature. These is no requirement for abatement of these emissions and recovery of the solvent is not possible due to the nature of the use.

4.2.6 Traffic Emissions

The impact of the proposed developments in terms of air quality impact from traffic emissions is presented in the Environmental Impact Assessment Report (EIAR) for both the east expansion, submitted with planning application Ref. 17/1170, and the EIAR for the ALB and MSCP, submitted with planning application Ref. 18/1098. These EIAR documents are presented in Section 6 of the IE licence review application.

The UK Highways Agency (2007) Design Manual for Roads and Bridges, on which the Transport Infrastructure Ireland (TII) guidance is based, states that road links meeting one or more of the following criteria can be defined as being ‘affected’ by a proposed development and should be included in a local air quality assessment:

• Road alignment change of 5 metres or more; • Daily traffic flow changes by 1,000 AADT or more; • HGV flows change by 200 vehicles per day or more; • Daily average speed changes by 10 km/h or more; or • Peak hour speed changes by 20 km/h or more.

Concentrations of key pollutants are calculated at sensitive receptors which have the potential to be affected by the proposed development. Road links which are affected by the proposed development and within 200 m of the chosen sensitive receptors are required for the model. There are no new road links which meet the above assessment criteria and therefore, modelling of traffic related impacts on air quality is not necessary. As a result, it can be determined that there will be no impact on air quality from traffic emissions as a result of the development.

During the movement of materials both on and off-site, trucks will be stringently

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covered with tarpaulin at all times. Before entrance onto public roads, trucks will be adequately inspected to ensure no potential for dust emissions.

5.0 NOISE IMPACTS 5.1 Noise Emissions

In terms of noise sources there are 2 no. elements to this assessment:

• Existing operation plant items; and,

• New Plant items for permitted, proposed and operational. 5.1.1 Existing Operational Plant Items

As outlined in Section 4.1, the existing Regeneron installation operates under a current IE licence from the EPA, which defines operation noise emission limits for the installation. Annual noise monitoring carried out in 2018 has confirmed that the site is operating in compliance with the noise limits. For the detailed noise assessment in Appendix B of this attachment, reference has been made to the noise assessment undertaken for the installation in 2014 as part of the previous IE licence application submitted to the EPA (document reference IE0311171-22-RP-0008, Issue: A, dated 14 April 2014).

5.1.2 New Operational Plant Items

There are several new plant items associated with the proposed and permitted development at the installation. Additional plant items have been commission on the site since the previous IE assessment in 2014 and these have been included as part of this assessment. There are also several items of noise generating equipment proposed for the new developments including the Administration and Laboratory Building (ALB) development and associated site changes. It has been assumed for this assessment that all plant items will operate 24 hours a day as a worst case and that all plant items have omni-directional noise emissions. The assessment considers all the major and minor noise sources of plant items that have been identified as having the potential to emit noise beyond the site boundary. The assessment has used conservative figures based on the worst-case information.

The main new sources of noise on the site are listed in the noise assessment provided as Appendix B of this attachment. The location of all new and existing plant items on the site are shown in Drawings 008 to 010. These include the existing noise sources at the current installation as well as the proposed noise sources for the ALB and associated site changes. Noise details for the east expansion were not know at the time of writing and therefore reference has been made to the noise impact assessment outlined in the relevant chapter of the EIAR completed as part of planning for the east expansion, as well as the EIAR completed as part of planning for the ALB and associated developments.

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5.2 Impact on Noise Environment 5.2.1 Noise Abatement

Control of noise will be considered as part of the detailed design of the new development at the installation. The principle of Best Available Techniques (BAT) as outlined in the NG4 Guidance shall be employed to control noise emissions and, where possible,

• external plant layout will utilise barrier screening of on-site buildings;

• low noise generating plant items will been selected;

• plant items will be located within fully enclosed plant rooms or ventilated plant enclosures louvred with attenuation;

• air handling units will be hard ducted to louvres or will have noise attenuation in series; and,

• all plant shall be selected such that there are no tonal or impulsive emissions.

5.2.2 Noise Assessment

A preliminary noise assessment has been carried out for the proposed installation in accordance with the Environmental Protection Agency (EPA) document Guidance Note for Noise: Licence Applications, Surveys and Assessments in Relation to Scheduled Activities (NG4) 2016. The objective of the noise impact assessment is to determine the expected cumulative noise emissions at the nearest noise sensitive locations for the existing and new mechanical plant items. This report is presented as Appendix B of this attachment. To quantify the existing noise environment at the nearest Noise Sensitive Locations (NSL’s) to the site reference has been made to annual noise monitoring reports and survey data conducted in 2017 and 2018 for Regeneron. To assess the impact of future noise emissions from the installation from both new and existing plant items at the nearest NSL’s, Prediction calculations for plant items have been conducted in general accordance with ISO 9613: Acoustics – Attenuation of sound during propagation outdoors, Part 2: General method of calculation, 1996.

In accordance with the relevant EPA NG4 Guidance, appropriate operational noise criteria have been derived for the site which are based on the existing noise environment at the nearest NSL’s. The criteria identified is in line with current noise emission limits applicable at the Regeneron installation. The applicable noise criteria are therefore:

Daytime dB LAr,T (15-30 minutes)

Evening time dB LAr,T (15-30 minutes)

Night-time dB LAeq,T (15-30 minutes)

55 50 45Note 1

Note 1 There shall be no clearly audible tonal component or impulsive component in the noise criteria from the activity at any noise-sensitive location.

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5.2.3 Impact on the Noise Environment

The preliminary noise assessment calculated that operational noise will be within the relevant day time and night time limits at the nearest noise sensitive receptors. It should be noted that as a worst case it is assumed that the plant is in operation continuously during daytime, evening, and night-time periods. Backup generators may operate in emergency situations and for periodic testing during daytime hours. The NG4 document allows for relaxed noise emission criteria for emergency use equipment; however, the worst case predicted noise emissions from the operation of the generators will be below the normal day, evening and night time noise criteria and any predicted increase in the noise emissions is expected to be not significant.

The EIAR for the ALB and MSCP concluded that the predicted increases to the existing noise levels would be ‘slight’ in that they would impact on the existing baseline but would not affect the character of the noise environment significantly at the nearest noise sensitive locations. An updated noise source location drawing showing the noise source locations for the east expansion will be provided to the EPA’s enforcement officer prior to commencement. The impact of noise from additional vehicular traffic on public roads was assessed as part of the EIAR for the east expansion as well as the EIAR for the new ALB and MSCP. Both EIARs concluded that the resultant change in the noise levels resulting from the increases in road traffic would be ‘imperceptible’ and that the likely noise impact of car park activities on the local environment is not significant.

6.0 IMPACTS TO GROUND 6.1 Soil and Groundwater Environment

The current condition of the Regeneron site, located at Raheen Business Park, Raheen, Co. Limerick, is covered in Sections 6.0 Stage 5 – Environmental Setting an 8.0 Stage 7 – Site Investigation and Baseline Soil & Water Quality Assessment of the Screening & Baseline report submitted as part of this application.

6.1.1 Geology Information obtained from the GSI (2018) indicates a sequence of different lithological groups within the area surrounding the site including basalt and other volcanic rocks. However, during the site investigations undertaken on site in 2013 under the supervision of the PM group the presence of fine to medium grained limestone was recorded beneath the site at depth from 0.8 to 4.1mbgl. This is consistent with the subsoil type identified by the GSI (2017) which includes glacial tills derived from limestone.

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During the May 2017 investigations undertaken by Ground Investigations Ireland ltd. under the supervision of the PM group, the depth to bedrock varied from 1.9 to 8.3 mbgl, with the shallower rock depths recorded on the western side of the new lands to the south west of the installation and in the ‘castle lands’. Weathered bedrock was also present. This is consistent with the finding of the site investigation undertaken by AWN in 2018 on the ‘castle lands’ during which bedrock was encountered between 0.5-3.8 mbgl.

6.1.2 Soil Type and Quality The site investigations undertaken under the supervision of the PM Group in September 2013 and May 2017 confirmed the site area is underlain by gravelly clays at the western boundary, fill material underlain by sandy gravely clays with boulders to the east with gravelly clays to the north west of the site. This was further confirmed during investigations carried out by AWN in August 2018. Made ground was also noted in the May 2017 investigations to a maximum depth of 1.6mbgl in some of the trial pits around the existing installation. Soil sampling for the existing site was undertaken as part of the Baseline Assessment completed by the PM Group and the results were presented with the 2014 IE licence application. The results indicated that there was no significant soil contamination at the site. Additional soil and groundwater sampling was undertaken under the supervision of the PM group in 2017 for the new lands, and analysis showed general compliance with groundwater regulations (S.I. No. 366 of 2016 & S.I. No. 9 of 2010) across the new lands. Further soil samples were collected for the ‘castle lands’ by AWN in August 2018 and the results indicated that the soil is relatively clean and there is no contamination present on site.

6.1.3 Groundwater Characteristics The GSI (2017) National Draft Bedrock Aquifer Map for the site indicates that the site is underlain by a (LI) Locally Important Bedrock Aquifer, which is moderately productive, only in local zones. LI classified aquifers characteristically have well yields in the order of 100m³ per day however according to the GSI well data base well yields are poor in the area around the site. This would indicate bedrock with low transmissivity (T) underlying the local area. The GSI (2017) also presently classifies the aquifer in the area of the subject site as predominantly High (H) vulnerability which indicates an overburden depth of 3-5m with low permeability soil present. The bedrock boreholes installed onsite during the 2013, 2017 and 2018 investigations showed that the depth to bedrock varies across the site but is between 0.5 to 7.8 mbgl confirming that the aquifer vulnerability ranges from high to extreme.

6.1.4 Groundwater Quality The European Communities Directive 2000/60/EC established a framework for community action in the field of water policy, (commonly known as the Water Framework Directive [WFD]). The WFD required ‘Good Water Status’ for all

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European waters by December 2015, to be achieved through a system of river basin management planning and extensive monitoring. ‘Good status’ means both ‘Good Ecological Status’ and ‘Good Chemical Status’. The Groundwater Body (GWB) underlying the site is Limerick City Southwest. Currently, the EPA (2018) on-line mapping classifies the Limerick Southwest body as having ‘Poor Status’, with a WFD risk of not achieving good status. Groundwater samples were collected across the existing site as part of the September 2013 site investigations completed under the supervision of the PM group (PM Group, 2014). Overall, the results indicated no significant groundwater contamination at the site. Further groundwater samples were collected as part of the May 2017 and August 2018 investigations for the new lands, and these confirmed that there is no evidence of significant soil or groundwater contamination at the site as a result of current operation or previous use. Groundwater samples are collected and analysed on a biannual basis in compliance with Regeneron’s IE Licence (Reg. No. P0991-01). The results are compared with the Groundwater Threshold Values (GTVs) from the European Communities Environmental Objectives (Groundwater) Regulations, S.I. 9 of 2010 & S.I. 366 of 2016. GTVs are trigger values (‘threshold’ values) which warn of potential breaches of water quality standards, but not water quality standards themselves. The last round of compliance monitoring in 2016 showed no exceedances above the available GTVs for PCB’s, pesticides, VOCs, sodium, total PAH’s and glycols.

6.2 Impact to Ground and Groundwater

There will be no direct discharges of contaminated water to groundwater or soil environment during operation. Proposed emissions of stormwater from the MSCP and the proposed contractors compound will be discharged to the engineered percolation areas via hydrocarbon interceptors; however, this discharge has been considered under ‘stormwater emissions’. As such, the only impact that could only occur is due to accidental emissions such as localised accidental leakages from cars/vehicles in the car park areas/ on site or accidental leakage from the bunded diesel storage tank and/ or chemical releases during refueling or transport.

During operation, an environmental management plan (EMP) will be in place to ensure compliance with licencing requirements. This will include full and adequate containment and management of potential contaminants. Site-specific emergency response measures will be in place and all relevant personnel will be trained accordingly.

6.2.1 Fuel and Chemical Handling In order to minimise any impact on the underlying sunken strata from material spillages, chemical storage tanks will be fully bunded in designated areas with an impervious loading area. Bunding will be to a volume in compliance with EPA standards.

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Drainage from the area around the bulk diesel storage area is via the 2 no. Class 1 full retention interceptors which will be inspected and properly managed. All tanks, concrete bunding and transfer pipelines will be tested regularly to confirm integrity as per the site EMP and licencing requirements.

6.2.2 Management of Underground Pipelines

There is potential for an accidental release of dilute process wastewater from the underground wastewater drainage network to impact on the soil and groundwater environments. In the event of a leak which is not mitigated, contaminated wastewater could enter the soil environment and infiltrate into the groundwater body through the high permeability sub-soils. Whilst the vulnerability of the aquifer has been shown by on site drilling to be high to moderate, the extent of the impact from a leaking effluent drain would be minor due to the nature of the wastewaters which contain only low levels of diluted contaminant. The integrity of the onsite drainage system undergoes regular inspections and checks and are integrity tested every 3 years in accordance with the requirements of the IE licence. All process drainage is double contained.

6.2.3 Groundwater Monitoring

Groundwater monitoring has been undertaken at four onsite wells, AGW1, AGW2, AGW3 and AGW4, as part of the existing licence requirements. Due to ongoing works on the site, including the development of the east expansion, three new wells have been installed (AGW5, AGW6 and AGW7) and these are now reported with AGW3 as part of compliance with the sites IE Licence. The locations of these wells are shown on Drawing 012. It is proposed that monitoring results are compared with current regulatory limits and guidelines, including the European Communities Environmental Objectives (Groundwater) Regulations 2010 (S.I. No. 9 of 2010) and the EPA (2003) Interim guidelines.

6.2.4 Impact to Ground and Groundwater

Operation of the plant will be according to BAT (Best Available Technology) principles and in compliance with the licence for the site to ensure that inputs to, and any subsequent contamination of, soil and water environments does not occur during normal and/ or emergency conditions (material spillage or fire event situations). As such, it is considered that other than those parameters that are natural elevated in the local groundwater body, there will be no impact on the quality of the groundwater. As such, it is anticipated that there will be no additional exceedances of the European Communities Environmental Objectives (Groundwater) Regulations 2010 (S.I. No. 9 of 2010) and the EPA (2003) Interim guidelines.

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7.0 COMPLIANCE WITH BEST AVAILABLE TECHNIQUES

The proposed installation is intended to replicate successful and proven technologies and processes already developed and in manufacture and use in existing facilities. The design team have assessed BAT and ensured compliance with the relevant BAT as a minimum requirement.

It is anticipated that in many cases, the technique that offers the highest level of protection to the environment will be BAT, but the Directive also requires that the likely costs and benefits of implementing a technique are considered.

7.1 Relevant Decisions on BAT

The following documents are considered potentially relevant in terms of BAT conclusions, BREF and BAT guidance:

• EU Conclusions on Best Available Techniques in Common Waste Water and Waste Gas Treatment/Management Systems in the Chemical Sector, June 2016;

• BREF document on Best Available Techniques for the Manufacture of Organic Fine Chemicals, August 2006;

• BREF document on Best Available Techniques for Energy Efficiency, February 2009;

• BREF document on Best Available Techniques for Emissions from Storage, July 2006.

Please refer to Attachments 4-7-1 to 4-7-4 for detailed assessments of compliance with BAT for each of the above listed BAT Reference (BREF) and BAT guidance documents. It is concluded from this assessment that the installation when completed will comply with the required best available techniques.

7.2 Emerging Techniques

An ‘Emerging technique’ is defined as a novel technique for an industrial emissions directive activity that, if commercially developed, could provide either a higher general level of protection of the environment or at least the same level of protection of the environment and higher cost savings than existing best available techniques. It is concluded that the proposed technology, based on successful and proven technologies and processes already developed and in manufacture and use at the existing installation, is not novel and no specific aspect is considered to represent an “Emerging technique”.

7.3 Cleaner Technologies, Waste Minimization and Raw Material Substitution

Please refer to Section 8 of the application for details regarding Waste Minimization.

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There are limited opportunities for the substitution of raw materials in the proposed process. The raw materials used have been developed carefully, with due respect to minimizing potential environmental nuisances or other consequences of their use.

Cleaner technologies are addressed in Section 9 under Energy Efficiency. 7.4 General Environmental Measures

Unlike traditional chemical based pharmaceutical facilities, the proposed installation will be a lower risk, cleaner, water-based bio-chemical manufacturing process using limited quantities of solvents or hazardous substances. The installation will be managed by an experienced team of bio-chemical specialists. All operatives will be trained for their specific duties and work will be carried out in line with standard operating procedures. In the event of an accident or other malfunction staff will be trained to address the accident as efficiently and effectively as possible thereby minimizing pollution arising therefrom. Following grant of the revised licence, Regeneron will be required to comply with the conditions of its licence. All emissions from the installation will be abated and monitored to ensure compliance. For further details of the controls in place, including accident prevention and management of liabilities, see Section 9.

8.0 CONCLUSIONS

From an assessment of both the direct and indirect emission sources, the proposed development is unlikely to have a significant impact on the air, noise, water and ground environments within the vicinity of the site. Monitoring of the emissions will be in accordance with the licence requirements. Diffuse discharges will be controlled through the use of sealed systems and standard operating procedures for control and maintenance. A further discussion on the impact from the direct emissions (i.e. air, sewer and stormwater emissions) to their respective receiving environment is provided in Attachment 7.1.3.3.

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9.0 REFERENCES

Annual Environmental Report (2017), D0013-01, Limerick (Bunlicky Wastewater Treatment Plant). Environmental Impact Services (2017) Environmental Impact Assessment Report for Internal Works & Change in Activity at Regeneron Ireland, Ballycummin, Raheen Business Park, Raheen, Co. Limerick. December 2017. Environmental Impact Services (2018) Environmental Impact Assessment Report for Proposed Administration/Laboratory Building and Multi-storey Carpark Development at Regeneron Ireland U.C., Ballycummin, Raheen Business Park, Raheen, Co. Limerick. November 2018. Environmental Protection Agency (EPA) Catchments data: available at https://www.catchments.ie/ . Accessed 2018. EPA Envision water quality monitoring data for watercourses in the area: On-line data resources available at http://gis.epa.ie/Envision/. Accessed 2018. EPA (2004) IPC Guidance Note on Storage and Transfer of Materials for Scheduled Activities. Geological Survey of Ireland (GSI): On-line mapping resources, available at www.gsi.ie including inter alia groundwater well database, Karst feature database, geology, hydrology, aquifer classification and vulnerability. Accessed 2018. National Parks & Wildlife Service (NPWS): On-line data resources available at http://webgis.npws.ie/npwsviewer/. Accessed 2018. Office of Public Works (OPW) National Flood Hazard Mapping - Flood points & Historical floods information: available at www.floodmaps.ie. Accessed 2018. Office of Public Works (OPW) Provisional Flood Risk Assessment (PFRA) maps, available at: http://www.cfram.ie/pfra/interactive-mapping/. Accessed 2018. PM Group (2017), Technical and Environmental Due Diligence Report for Regeneron Site (June 2017). PM Group (2014), Baseline Report for Regeneron Ireland (April 2014).

PM Group (2013), Environmental Impact Statement for Regeneron Ireland (December 2013). Relevant Eastern Catchment Flood Risk Assessment and Management (CFRAM) Flood Reports, available at: http://www.opw.ie/en/floodplans/ or www.floodinfo.ie. Accessed 2018.

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https://www.catchments.ie/

http://gis.epa.ie/Envision/

http://www.gsi.ie/

http://webgis.npws.ie/npwsviewer/

http://www.floodmaps.ie/

http://www.cfram.ie/pfra/interactive-mapping/

http://www.opw.ie/en/floodplans/

http://www.floodinfo.ie/


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Scott Cawley Ltd. (2018) Natura Impact Statement for Provision of Appropriate Assessment for Proposed Development at Regeneron, Raheen Business Park, Limerick. November 2018. Shannon International River Basin Management Plan (SRBD) Management Plan– 2009-2015.

UK Highways Agency (2007) Design Manual for Roads and Bridges, Volume 11, Section 3, Part 1 - HA207/07 (Document & Calculation Spreadsheet)

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Appendix A

Air Dispersion Modelling

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Tecpro Building, ~ chnology Park, The h Business & e Clonshaug Dublin 17, Ireland.

353 1 847 4220 T: + 1 847 4257 F: + 353 suiting.com . f @awncon E: in o ulting.com W: www.awncons

~consulting

_____________________________________

Technical Report Prepared For

Regeneron Biologics, Raheen,

Co. Limerick

_____________________________________ Technical Report Prepared By

Ciara Nolan MSc. AMIAQM

_____________________________________

Our Reference

CN/18/10093AR01

____________________________________

Date Of Issue

25th September 2018

_____________________________________

AIR DISPERSION MODELLING OF EMISSIONS

TO ATMOSPHERE FROM THE REGENERON

BIOLOGICS FACILTY, RAHEEN,

CO. LIMERICK

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CN/18/10093AR01 AWN Consulting Limited _____________________________________________________________________________________________________

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Document History

Document Reference Original Issue Date

18/10093AR01 25 September 2018

Revision Level Revision Date Description Sections Affected

Record of Approval

Details Written by Approved by

Signature

Name Ciara Nolan Avril Challoner

Title Air Quality Consultant Senior Air Quality Consultant

Date 25 September 2018 25 September 2018

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EXECUTIVE SUMMARY Air dispersion modelling was carried out using the United States Environmental Protection Agency’s regulatory model AERMOD (Version 18081) based on emissions from the Regeneron Ireland U.C. installation in Raheen, Co. Limerick, for their IE Licence review application. The purpose of this modelling study is to determine whether the emissions from the upgraded Regeneron installation will lead to ambient concentrations which are in compliance with the relevant ambient air quality standards for NO2.

The study consists of the following components:

• Review of emission data and other relevant information needed for the modelling study;

• Summary of background NO2 levels;

• Dispersion modelling of released substances under a worst-case emission scenario;

• Presentation of predicted ground level concentrations of released substances;

• Evaluation of the significance of these predicted concentrations, including consideration of whether these ground level concentrations are likely to exceed the relevant ambient air quality limit values.

Assessment Summary The results indicate that the ambient ground level concentrations of nitrogen oxides (as NO2) are below the annual and 1-hour ambient air quality standards. Emissions from the installation lead to an ambient NO2 concentration (including background) which is 55% of the maximum 1-hour limit (measured as a 99.8th percentile) and 63% of the annual limit at the worst-case off-site location for the worst-case years modelled (2017 and 2014 respectively). Ambient levels of nitrogen oxides (as NO2) from the installation are well below the air quality limit values for the protection of human health and it is predicted that air emissions from the installation will not have a significant impact on the local environment

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CONTENTS Page

Executive Summary 3

1.0 Introduction 5

2.0 Modelling Methodology 5

2.1 Background Concentrations 6

2.2 Ambient Air Quality Standards 7

2.3 Air Dispersion Modelling Methodology 7

2.4 Terrain 8

2.5 Meteorological Data 9

2.6 Process Emissions 9

3.0 Results & Discussion 12

3.1 Nitrogen Oxides (as NO2) 12

3.2 Assessment Summary 15

References 16

Appendix I – Description of the AERMOD Model 17

Appendix II – Meteorological Data - AERMET 18

Appendix III - Detailed Meteorological Data – Shannon Airport 20

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1.0 INTRODUCTION AWN Consulting Ltd. were commissioned to carry out an air dispersion modelling study of emissions from the Regeneron Ireland U.C. installation, Raheen, Co. Limerick for their IE Licence review application. The purpose of this modelling study is to determine whether the emissions from the site will lead to ambient concentrations which are in compliance with the relevant ambient air quality standards for NO2. This report describes the outcome of this study. The study consists of the following components:

• Review of emission data and other relevant information needed for the modelling study;

• Summary of background NO2 levels;

• Dispersion modelling of released substances under a worst-case emission scenario;

• Presentation of predicted ground level concentrations of released substances;

• Evaluation of the significance of these predicted concentrations, including consideration of whether these ground level concentrations are likely to exceed the relevant ambient air quality limit values.

Information supporting the conclusions has been detailed in the following sections. The assessment methodology and study inputs are presented in Section 2. The dispersion modelling results and assessment summaries are presented in Section 3. The model formulation is detailed in Appendix I and a review of the meteorological data used is detailed in Appendix II and Appendix III.

2.0 MODELLING METHODOLOGY Emissions from the installation have been modelled using the AERMOD dispersion model (Version 18081) which has been developed by the U.S. Environmental Protection Agency (USEPA)(1) and following guidance issued by the EPA(2). The model is a steady-state Gaussian plume model used to assess pollutant concentrations associated with industrial sources and has replaced ISCST3(3) as the regulatory model by the USEPA for modelling emissions from industrial sources in both flat and rolling terrain(4-6). The model has more advanced algorithms and gives better agreement with monitoring data in extensive validation studies(7-11). An overview of the AERMOD dispersion model is outlined in Appendix I. The air dispersion modelling input data consisted of information on the physical environment (including building dimensions and terrain features), design details from all relevant emission points on-site and five full years of appropriate meteorological data. Using this input data the model predicted ambient ground level concentrations beyond the site boundary for each hour of the modelled meteorological year. The model post-processed the data to identify the location and maximum of the worst-case ground level concentration. This worst-case concentration was then added to the background concentration to give the worst-case predicted environmental concentration (PEC). The PEC was then compared with the relevant ambient air quality standard to assess the significance of the releases from the site. Throughout this study a worst-case approach was taken. This will most likely lead to an over-estimation of the levels that will arise in practice. The worst-case assumptions are outlined below:

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• Maximum predicted concentrations were reported in this study, even if no residential receptors were near the location of this maximum;

• The effects of building downwash, due to on-site buildings, have been included in the model;

• All emission points were assumed to run continuously, every hour of the day, 365 days per year.

The Ozone Limiting Method (OLM) was used to model NO2 concentrations. The OLM is a regulatory option in AERMOD which calculates ambient NO2 concentrations by applying a background ozone concentration and an in-stack NO2/NOX ratio to predicted NOX concentrations. An in-stack NO2/NOX ratio of 0.1 and a background ozone concentration of 60 µg/m3 were used for modelling.

Background Concentrations

Air quality monitoring programs have been undertaken in recent years by the EPA and Local Authorities(12,13). The most recent annual report on air quality “Air Quality Monitoring Annual Report 2016”(13), details the range and scope of monitoring undertaken throughout Ireland. As part of the implementation of the Framework Directive on Air Quality (1996/62/EC), four air quality zones have been defined in Ireland for air quality management and assessment purposes(13). Dublin is defined as Zone A and Cork as Zone B. Zone C is composed of 23 towns with a population of greater than 15,000. The remainder of the country, which represents rural Ireland but also includes all towns with a population of less than 15,000 is defined as Zone D. In terms of air monitoring, Raheen, Co. Limerick is categorised as Zone C(13). NO2 monitoring was carried out at the Zone C monitoring stations of Kilkenny, Portlaoise and Mullingar in 2016(12). The NO2 annual average in 2016 for the locations of Kilkenny and Portlaoise were 7 and 11 μg/m3, respectively. This is significantly lower than the annual average limit value of 40 μg/m3. The average results over the last five years at a range of Zone C locations suggests an upper average of no more than 13 µg/m3 as a background concentration as shown in Table 1. Based on the above information, a conservative estimate of the current background NO2 concentration in the region of the Regeneron installation is 13 µg/m3.

Year Kilkenny Portlaoise Mullingar

2012 4 - 7

2013 4 - 6

2014 5 16 4

2015 5 10 -

2016 7 11 -

Average 5.0 12.3 5.7

Table 1 Annual Average NO2 Concentrations – Zone C(13)

In relation to the annual average background, the ambient background concentration was added directly to the process concentration with the short-term peaks assumed to have an ambient background concentration of twice the annual mean background concentration.

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Ambient Air Quality Standards In order to reduce the risk to health from poor air quality, national and European statutory bodies have set limit values in ambient air for a range of air pollutants. These limit values or “Air Quality Standards” are health or environmental-based levels for which additional factors may be considered. Air quality significance criteria are assessed on the basis of compliance with the appropriate standards or limit values. The applicable standards in Ireland include the Air Quality Standards Regulations 2011, which incorporate EU Directive 2008/50/EC which combines the previous air quality framework and subsequent daughter directives (see Table 2). Although the EU Air Quality Limit Values are the basis of legislation, other thresholds outlined by the EU Directives are used which are triggers for particular actions. The ambient air quality standards applicable for NO2 are outlined in Directive 2008/50/EC (see Table 2). These standards have been used in the current assessment to determine the potential impact of NO2 emissions from the installation on air quality.

Pollutant Regulation Note 1 Limit Type Value

Nitrogen Dioxide (NO2)

2008/50/EC

Hourly limit for protection of human health - not to be exceeded more than 18 times/year

200 μg/m3 NO2

Annual limit for protection of human health

40 μg/m3 NO2

Critical level for the protection of vegetation

30 μg/m3 NO + NO2

Note 1 EU 2008/50/EC – Clean Air For Europe (CAFÉ) Directive replaces the previous Air Framework Directive (1996/30/EC) and daughter directives 1999/30/EC and 2000/69/EC

Table 2 Air Quality Standards Regulations 2011 (Based on Directive 2008/50/EC and S.I. 180 of 2011)

2.3 Air Dispersion Modelling Methodology

The United States Environmental Protection Agency (USEPA) approved AERMOD dispersion model has been used to predict the ground level concentrations (GLC) of compounds emitted from the principal emission sources on-site. The modelling incorporated the following features:

• Two receptor grids were created at which concentrations would be modelled. Receptors were mapped with sufficient resolution to ensure all localised “hot-spots” were identified without adding unduly to processing time. The receptor grids were based on Cartesian grids with the site at the centre. An outer grid measured 9 x 9 km with concentrations calculated at 300 m intervals. A smaller grid measured 4 x 4 km with concentrations calculated at 50 m intervals. Boundary receptor locations were also placed along the boundary of the site at 25 m intervals giving a total of 7,636 calculation points for the model.

• Hourly-sequenced meteorological information has been used in the model. The 2013 – 2017 meteorological data from Shannon Airport has been used in the assessment.

• AERMOD incorporates a meteorological pre-processor AERMET(14). The AERMET meteorological pre-processor requires the input of surface characteristics, including surface roughness (z0), Bowen Ratio and albedo by sector and season, as well as hourly observations of wind speed, wind direction,

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cloud cover, and temperature. The values of albedo, Bowen Ratio and surface roughness depend on land-use type (e.g., urban, cultivated land etc) and vary with seasons and wind direction. The assessment of appropriate land-use type was carried out to a distance of 10km from the meteorological station for Bowen Ratio and albedo and to a distance of 1km for surface roughness in line with USEPA recommendations(15).

• The source and emissions data, including stack dimensions, gas volumes and emission temperatures have been incorporated into the model.

• Detailed terrain has been mapped into the model using SRTM (Shuttle Radar Topography Mission) data with 30 m resolution. The site is located in relatively flat terrain. All terrain features have been mapped in detail into the model using the terrain pre-processor AERMAP.

Modelling for NO2 was undertaken in detail. However, emissions of carbon monoxide (CO) may also be present in the exhaust gases. In relation to CO, no detailed modelling was undertaken. Emissions of CO are significantly lower than the NOX emissions from the boilers relative to the ambient air quality standards. The CO ambient air quality standard is 10,000 µg/m3 compared to the 1-hour NO2 standard of 200 µg/m3. Thus, ensuring compliance with the NO2 ambient limit value will ensure compliance for any other pollutants.

2.4 Terrain

The AERMOD air dispersion model has a terrain pre-processor AERMAP which was used to map the physical environment over the receptor grid. The digital terrain input data used in the AERMAP pre-processor was SRTM data. This data was run to obtain for each receptor point the terrain height and the terrain height scale. The terrain height scale is used in AERMOD to calculate the critical dividing streamline height, Hcrit, for each receptor. The terrain height scale is derived from the Digital Elevation Model (DEM) files in AERMAP by computing the relief height of the DEM point relative to the height of the receptor and determining the slope. If the slope is less than 10%, the program goes to the next DEM point. If the slope is 10% or greater, the controlling hill height is updated if it is higher than the stored hill height. In areas of complex terrain, AERMOD models the impact of terrain using the concept of the dividing streamline (Hc). As outlined in the AERMOD model formulation(1) a plume embedded in the flow below Hc tends to remain horizontal; it might go around the hill or impact on it. A plume above Hc will ride over the hill. Associated with this is a tendency for the plume to be depressed toward the terrain surface, for the flow to speed up, and for vertical turbulent intensities to increase. AERMOD model formulation states that the model “captures the effect of flow above and below the dividing streamline by weighting the plume concentration associated with two possible extreme states of the boundary layer (horizontal plume and terrain-following). The relative weighting of the two states depends on: 1) the degree of atmospheric stability; 2) the wind speed; and 3) the plume height relative to terrain. In stable conditions, the horizontal plume "dominates" and is given greater weight while in neutral and unstable conditions, the plume traveling over the terrain is more heavily weighted”(1). AERMOD also has the capability of modelling both unstable (convective) conditions and stable (inversion) conditions. The stability of the atmosphere is defined by the sign of the sensible heat flux. Where the sensible heat flux is positive, the atmosphere is unstable whereas when the sensible heat flux is negative the atmosphere is defined as

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stable. The sensible heat flux is dependent on the net radiation and the available surface moisture (Bowen Ratio). Under stable (inversion) conditions, AERMOD has specific algorithms to account for plume rise under stable conditions, mechanical mixing heights under stable conditions and vertical and lateral dispersion in the stable boundary layer.

2.5 Meteorological Data

The selection of the appropriate meteorological data has followed the guidance issued by the USEPA(3) and EPA(2). A primary requirement is that the data used should have a data capture of greater than 90% for all parameters. Shannon Airport meteorological station, which is located approximately 19 km north-west of the site, collects data in the correct format and has a data collection of greater than 90%. Hourly observations at Shannon Airport meteorological station provide an indication of the prevailing wind conditions for the region. Results indicate that the prevailing wind direction is from south-westerly to westerly in direction (see Figure 1) and there are no missing hours over the period 2013 – 2017 (see Appendix III).

2.6 Process Emissions The existing installation has 5 no. licenced steam boilers, A1-1 to A1-5, which have a stack height of 25 m above ground level. There are also 2 no. Low Pressure Hot Water (LPHW) boilers, A1-6 and A1-7, in the existing installation which will be licenced as part of this review application and these have a stack height of 17 m above ground level. The bulk biologics extension (the ‘east expansion’) to the north-east portion of the site will have two new boiler stacks, ‘New B01’ and ‘New B02’, which will be at a height of 20 m above ground level. The source information for the modelled emission points can be seen in Table 3. The new boiler stacks have been based on the current licenced boiler design details and the current boiler licence limits have been applied to the new boilers for the purposes of this modelling assessment. Emission concentrations for boilers A1-6 and A1-7 have also been based on the current licenced boiler details. Actual emissions from these two points are potentially lower than modelled but for licencing purposes a worst-case approach has been undertaken. The traffic associated with the installation expansion has also been reviewed as it may contribute to ambient levels of NO2. The increased traffic flows have been assessed against the UK DMRB screening criteria(17) and are below the magnitude requiring a qualitative assessment. As such it can be determined that emissions of NO2 as a result of traffic from the installation are insignificant with regards to the ambient air quality.

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Stack Reference

Height Above

Ground Level (m)

Exit Diameter

(m)

Cross-Sectional Area (m2)

Temp (K) Note 1

Max Volume

Flow (Nm3/hr)

Note 2

Exit Velocity (m/sec actual)

NO2

Mass Emission

(g/s)Notes 3, 4

A1-1 25 0.6 0.28 399.2 6,227 8.94 0.173

A1-2 25 0.6 0.28 390.2 6,371 8.94 0.177

A1-3 25 0.6 0.28 384.1 6,472 8.94 0.180

A1-4 25 0.6 0.28 380.8 6,528 8.94 0.181

A1-5 25 0.6 0.28 358.6 6,933 8.94 0.193

A1-6 17 0.35 0.10 353.2 3,435 14.44 0.095

A1-7 17 0.35 0.10 353.2 3,435 14.44 0.095

New B01 20 0.6 0.28 472.2 5,265 8.94 0.146

New B02 20 0.6 0.28 472.2 5,265 8.94 0.146

Note 1 Kelvin (K) SI Unit for Temperature

Note 2 Nm3/hr Cubic Metres per Hour measured under normal temperature and pressure conditions Note 3 Fuel type for boilers is natural gas Note 4 (g/s) Grams per Second Note 5 Boilers have been modelled at 3% O2 and 0% moisture content Table 3 Regeneron, Raheen, Co. Limerick - Process Emissions Details

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Shannon Airoort 2016 Shannon Airport 2017 N N

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3.0 RESULTS & DISCUSSION

Nitrogen Oxides (as NO2)

The nitrogen oxide modelling results are detailed in Table 4. The results indicate that the ambient ground level concentrations are below the annual and 1-hour ambient air quality standards. Emissions from the installation lead to an ambient NO2 concentration (including background) which is 55% of the maximum 1-hour limit (measured as a 99.8th percentile) and 63% of the annual limit at the worst-case off-site location for the worst-case years modelled (2017 and 2014 respectively). The geographical variations in ground level NO2 concentrations beyond the installation boundary for the worst-case years modelled are illustrated as concentration contours in Figures 2 and 3. The contents of each figure are described below: Figure 2 Predicted Hourly Maximum NO2 Concentrations (2014) Figure 3 Predicted Annual Mean NO2 Concentrations (2017) The locations of the maximum concentrations for NO2 are close to the boundary of the site with concentrations decreasing with distance from the installation.

Pollutant / Meteorological

Year

Background (µg/m3)

Averaging Period

Process Contribution NO2 (µg/m3)

Predicted Emission

Concentration NO2 (µg/m3)

Standard (µg/m3)

Note 1

NO2 / 2013

13 Annual Mean 10.3 23.3 40

26 99.8th%ile of 1-hr

means 83.4 109.4 200

NO2 / 2014

13 Annual Mean 10.6 23.6 40


means 83.7 109.7 200

NO2 / 2015

13 Annual Mean 10.3 23.3 40


means 79.5 105.5 200

NO2 / 2016

13 Annual Mean 9.9 22.9 40


means 83.5 109.5 200

NO2 / 2017

13 Annual Mean 12.0 25.0 40


means 83.6 109.6 200

Note 1 Air Quality Standards 2011 (from EU Directive 2008/50/EC and S.I. 180 of 2011) Table 4 Dispersion Model Results for Nitrogen Oxides (as NO2)

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Figure 2

Max 1-Hour N02 Concentrations (as 99.8%ile) (µg/m') (excluding background cone entrations)

Reference 18/10093AR01

Project Regeneron IED Licence Review Application

Background mapping from Google Earth

1:55,000

Scale

Maximum concentration: 83.7µg/m'

D Site boundary

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1 30 µg/m3

20 µg/m3

10 µg/m3

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Annual Mean N02 Concentrations (µg/m') (excluding background concentrations)

fu Tecpro B~. Clooshaugh Sostessard T~ ?a*. OllJblin 17 T: +3...'".3 I 847 4220 F: +35.3 1 &47 ~257

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1.0 µg/m1

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m•

D Site boundary

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Assessment Summary In conclusion, ambient levels of nitrogen oxides (as NO2) from the installation are in compliance with the air quality limit values for the protection of human health and it is predicted that air emissions from the installation will not have a significant impact on the local environment.

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References (1) USEPA (2017) AERMOD Description of Model Formulation and Evaluation (2) EPA (2010) Air Dispersion Modelling from Industrial Installations Guidance Note (AG4) (3) USEPA (1995) User’s Guide for the Industrial Source Complex (ISC3) Dispersion Model

Vol I & II (4) USEPA (2016) Guidelines on Air Quality Models, Appendix W to Part 51, 40 CFR Ch.1 (5) USEPA (2000) Seventh Conference on Air Quality Modelling (June 2000) Vol I & II (6) USEPA (1998) Human Health Risk Assessment Protocol, Chapter 3: Air Dispersion and

Deposition Modelling, Region 6 Centre for Combustion Science and Engineering (7) USEPA (1999) Comparison of Regulatory Design Concentrations: AERMOD vs. ISCST3

vs. CTDM PLUS (8) Schulman et al “Development and evaluation of the PRIME Plume Rise and Building

Downwash Model” Air & Waste Management Association, 1998. (9) Paine, R & Lew, F. “Consequence Analysis for Adoption of PRIME: an Advanced Building

Downwash Model” Prepared for the EPRI, ENSR Document No. 2460-026-450 (1997). (10) Paine, R & Lew, F. “Results of the Independent Evaluation of ISCST3 and ISC-PRIME”

Prepared for the EPRI, ENSR Document No. 2460-026-3527-02 (1997). (11) USEPA (2000) Estimating Exposure to Dioxin-Like Compounds Volume IV, Chapter 3

Evaluating Atmospheric Releases of Dioxin-Like Compounds from Combustion Sources (Draft)

(12) EPA (2018) http://www.epa.ie/air/quality/data/ (13) EPA (2017) Air Quality Monitoring Report 2016 (and previous reports) (14) USEPA (2004) User’s Guide to the AERMOD Meteorological Preprocessor (AERMET) (15) Hanrahan, P (1999a) The Plume Volume Molar Ratio Method for Determining NO2/NOX

Ratios in Modeling – Part 1: Methodology J. Air & Waste Management Assoc. 49 1324-1331.

(16) Hanrahan, P (1999b).The Plume Volume Molar Ratio Method for Determining NO2/NOX Ratios in Modeling – Part 21: Evaluation Studies J. Air & Waste Management Assoc. 49 1332-1338.

(17) UK Highways Agency (2007) Design Manual for Roads and Bridges Vol 11 Chapter 3, HA 207/07 (Document & Calculation Spreadsheet)

(18) USEPA (2008) AERSURFACE User’s Guide (19) Alaska Department of Environmental Conservation (2008) ADEC Guidance re AERMET

Geometric Means (http://dec.alaska.gov/air/ap/modeling.htm)

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APPENDIX I

Description of the AERMOD Model The AERMOD dispersion model has been recently developed in part by the U.S. Environmental Protection Agency (USEPA)(1). The model is a steady-state Gaussian model used to assess pollutant concentrations associated with industrial sources. The model is an enhancement on the Industrial Source Complex-Short Term 3 (ISCST3) model which has been widely used for emissions from industrial sources. Improvements over the ISCST3 model include the treatment of the vertical distribution of concentration within the plume. ISCST3 assumes a Gaussian distribution in both the horizontal and vertical direction under all weather conditions. AERMOD with PRIME, however, treats the vertical distribution as non-Gaussian under convective (unstable) conditions while maintaining a Gaussian distribution in both the horizontal and vertical direction during stable conditions. This treatment reflects the fact that the plume is skewed upwards under convective conditions due to the greater intensity of turbulence above the plume than below. The result is a more accurate portrayal of actual conditions using the AERMOD model. AERMOD also enhances the turbulence of night-time urban boundary layers thus simulating the influence of the urban heat island. In contrast to ISCST3, AERMOD is widely applicable in all types of terrain. Differentiation of the simple versus complex terrain is unnecessary with AERMOD. In complex terrain, AERMOD employs the dividing-streamline concept in a simplified simulation of the effects of plume-terrain interactions. In the dividing-streamline concept, flow below this height remains horizontal, and flow above this height tends to rise up and over terrain. Extensive validation studies have found that AERMOD (precursor to AERMOD with PRIME) performs better than ISCST3 for many applications and as well or better than CTDMPLUS for several complex terrain data sets(7). AERMOD has made substantial improvements in the area of plume growth rates in comparison to ISCST3(1). ISCST3 approximates turbulence using six Pasquill-Gifford-Turner Stability Classes and bases the resulting dispersion curves upon surface release experiments. This treatment, however, cannot explicitly account for turbulence in the formulation. AERMOD is based on the more realistic modern planetary boundary layer (PBL) theory which allows turbulence to vary with height. This use of turbulence-based plume growth with height leads to a substantial advancement over the ISCST3 treatment. Improvements have also been made in relation to mixing height(1). The treatment of mixing height by ISCST3 is based on a single morning upper air sounding each day. AERMOD, however, calculates mixing height on an hourly basis based on the morning upper air sounding and the surface energy balance, accounting for the solar radiation, cloud cover, reflectivity of the ground and the latent heat due to evaporation from the ground cover. This more advanced formulation provides a more realistic sequence of the diurnal mixing height changes. AERMOD also contains improved algorithms for dealing with low wind speed (near calm) conditions. As a result, AERMOD can produce model estimates for conditions when the wind speed may be less than 1 m/s, but still greater than the instrument threshold.

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APPENDIX II

Meteorological Data - AERMET AERMOD incorporates a meteorological pre-processor AERMET (version 18081)(18). AERMET allows AERMOD to account for changes in the plume behaviour with height. AERMET calculates hourly boundary layer parameters for use by AERMOD, including friction velocity, Monin-Obukhov length, convective velocity scale, convective (CBL) and stable boundary layer (SBL) height and surface heat flux. AERMOD uses this information to calculate concentrations in a manner that accounts for changes in dispersion rate with height, allows for a non-Gaussian plume in convective conditions, and accounts for a dispersion rate that is a continuous function of meteorology. The AERMET meteorological pre-processor requires the input of surface characteristics, including surface roughness (z0), Bowen Ratio and albedo by sector and season, as well as hourly observations of wind speed, wind direction, cloud cover, and temperature. A morning sounding from a representative upper air station, latitude, longitude, time zone, and wind speed threshold are also required. Two files are produced by AERMET for input to the AERMOD dispersion model. The surface file contains observed and calculated surface variables, one record per hour. The profile file contains the observations made at each level of a meteorological tower, if available, or the one-level observations taken from other representative data, one record level per hour. From the surface characteristics (i.e. surface roughness, albedo and amount of moisture available (Bowen Ratio)) AERMET calculates several boundary layer parameters that are important in the evolution of the boundary layer, which, in turn, influences the dispersion of pollutants. These parameters include the surface friction velocity, which is a measure of the vertical transport of horizontal momentum; the sensible heat flux, which is the vertical transport of heat to/from the surface; the Monin-Obukhov length which is a stability parameter relating the surface friction velocity to the sensible heat flux; the daytime mixed layer height; the nocturnal surface layer height and the convective velocity scale which combines the daytime mixed layer height and the sensible heat flux. These parameters all depend on the underlying surface. The values of albedo, Bowen Ratio and surface roughness depend on land-use type (e.g., urban, cultivated land etc) and vary with seasons and wind direction. The assessment of appropriate land-use types was carried out in line with USEPA recommendations(4) and using the detailed methodology outlined by the Alaska Department of Environmental Conservation(19). AERMET has also been updated to allow for an adjustment of the surface friction velocity (u*) for low wind speed stable conditions based on the work of Qian and Venkatram (BLM, 2011). Previously, the model had a tendency to over-predict concentrations produced by near-ground sources in stable conditions. Surface roughness Surface roughness length is the height above the ground at which the wind speed goes to zero. Surface roughness length is defined by the individual elements on the landscape such as trees and buildings. In order to determine surface roughness length, the USEPA recommends that a representative length be defined for each sector, based on an upwind area-weighted average of the land use within the sector, by using the eight land use categories outlined by the USEPA. The inverse-distance weighted surface roughness length derived from the land use classification within a radius of 1km from Shannon Airport Meteorological Station is shown in Table A1.

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Sector Area Weighted Land Use Classification Spring Summer Autumn WinterNote 1

270-180 100% Grassland 0.05 0.10 0.01 0.01

180-270 100% Urban 1 1 1 1

(1) Winter defined as periods when surfaces covered permanently by snow whereas autumn is defined as periods when freezing conditions are common, deciduous trees are leafless and no snow is present (Iqbal (1983))(19). Thus, for the current location autumn more accurately defines “winter” conditions in Ireland.

Table A1 Surface Roughness based on an inverse distance weighted average of the land use within a 1km radius of Shannon Airport Meteorological Station.

Albedo Noon-time albedo is the fraction of the incoming solar radiation that is reflected from the ground when the sun is directly overhead. Albedo is used in calculating the hourly net heat balance at the surface for calculating hourly values of Monin-Obuklov length. A 10km x 10km square area is drawn around the meteorological station to determine the albedo based on a simple average for the land use types within the area independent of both distance from the station and the near-field sector. The classification within 10km from Shannon Airport Meteorological Station is shown in Table A2.

Area Weighted Land Use Classification Spring Summer Autumn WinterNote 1

6% Urban, 49% Grassland, 45% Water 0.151 0.143 0.172 0.172

(1) For the current location autumn more accurately defines “winter” conditions in Ireland.

Table A2 Albedo based on a simple average of the land use within a 10km × 10km grid centred on Shannon Airport Meteorological Station.

Bowen Ratio The Bowen ratio is a measure of the amount of moisture at the surface of the earth. The presence of moisture affects the heat balance resulting from evaporative cooling which, in turn, affects the Monin-Obukhov length which is used in the formulation of the boundary layer. A 10km x 10km square area is drawn around the meteorological station to determine the Bowen Ratio based on geometric mean of the land use types within the area independent of both distance from the station and the near-field sector. The classification within 10km from Shannon Airport Meteorological Station is shown in Table A3.

Area Weighted Land Use Classification Spring Summer Autumn WinterNote 1

19% Urban, 81% Grassland 0.301 0.557 0.655 0.655

(1) For the current location autumn more accurately defines “winter” conditions in Ireland.

Table A3 Bowen Ratio based on a geometric mean of the land use within a 10km × 10km grid centred on Shannon Airport Meteorological Station.

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APPENDIX III

Detailed Meteorological Data – Shannon Airport 2013 - 2017 Shannon Airport 2013

Dir \ Spd <= 1.54 <= 3.09 <= 5.14 <= 8.23 <= 10.80 > 10.80 Total

0.0 106 42 65 9 0 0 222

22.5 91 57 111 27 2 0 288

45.0 57 33 74 33 9 1 207

67.5 38 30 88 48 2 0 206

90.0 56 83 339 305 42 18 843

112.5 64 148 390 209 61 14 886

135.0 58 74 223 164 50 10 579

157.5 36 52 221 193 75 12 589

180.0 32 77 265 128 27 28 557

202.5 23 77 170 179 26 32 507

225.0 42 77 237 161 60 36 613

247.5 72 146 461 330 96 59 1,164

270.0 97 99 349 324 112 47 1,028

292.5 68 79 173 91 41 10 462

315.0 69 77 112 58 5 1 322

337.5 61 58 99 27 2 0 247

Total 970 1,209 3,377 2,286 610 268 8,720

Calms 40

Missing 0

Total 8,760

Shannon Airport 2014

Dir \ Spd <= 1.54 <= 3.09 <= 5.14 <= 8.23 <= 10.80 > 10.80 Total

0.0 118 84 112 12 2 0 328

22.5 66 80 98 25 0 0 269

45.0 56 21 44 9 0 0 130

67.5 44 23 53 14 0 1 135

90.0 102 111 332 132 18 2 697

112.5 96 181 418 81 26 5 807

135.0 65 77 250 135 34 15 576

157.5 56 71 257 222 64 27 697

180.0 58 68 229 159 62 22 598

202.5 60 52 203 207 61 10 593

225.0 62 100 250 211 64 39 726

247.5 68 126 402 335 133 74 1,138

270.0 91 113 352 271 49 45 921

292.5 58 61 166 67 6 0 358

315.0 61 92 118 35 1 0 307

337.5 87 100 153 60 0 0 400

Total 1,148 1,360 3,437 1,975 520 240 8,680

Calms 80

Missing 0

Total 8,760

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Dir \ Spd <= 1.54 <= 3.09 <= 5.14 <= 8.23 <= 10.80 > 10.80 Total

0.0 146 66 93 10 0 0 315

22.5 68 49 79 19 0 0 215

45.0 52 33 45 5 0 0 135

67.5 48 29 43 8 0 0 128

90.0 70 73 256 96 4 0 499

112.5 64 130 426 159 49 2 830

135.0 48 64 198 130 49 9 498

157.5 47 40 268 233 72 29 689

180.0 36 58 327 216 79 18 734

202.5 25 51 223 216 107 55 677

225.0 39 61 212 224 77 81 694

247.5 50 77 337 372 195 102 1,133

270.0 76 94 355 361 123 59 1,068

292.5 66 67 162 127 38 6 466

315.0 71 94 129 34 4 0 332

337.5 74 85 120 13 0 0 292

Total 980 1,071 3,273 2,223 797 361 8,705

Calms 55

Missing 0

Total 8,760


Dir \ Spd <= 1.54 <= 3.09 <= 5.14 <= 8.23 <= 10.80 > 10.80 Total

0.0 137 75 100 18 0 0 330

22.5 68 86 162 42 0 0 358

45.0 57 38 76 27 4 1 203

67.5 40 43 106 17 5 1 212

90.0 65 93 288 102 6 4 558

112.5 89 131 423 138 35 5 821

135.0 70 97 236 115 27 1 546

157.5 47 64 313 191 57 23 695

180.0 38 76 308 150 35 13 620

202.5 43 68 245 126 27 11 520

225.0 43 65 219 213 57 31 628

247.5 50 104 397 371 113 87 1,122

270.0 97 102 309 319 70 22 919

292.5 64 75 128 113 27 7 414

315.0 90 93 132 61 2 0 378

337.5 70 79 164 67 4 0 384

Total 1,068 1,289 3,606 2,070 469 206 8,708

Calms 76

Missing 0

Total 8,784

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Dir \ Spd <= 1.54 <= 3.09 <= 5.14 <= 8.23 <= 10.80 > 10.80 Total

0.0 108 53 56 46 4 0 267

22.5 42 29 70 18 9 0 168

45.0 38 20 30 14 2 0 104

67.5 33 16 37 39 1 0 126

90.0 63 66 118 61 30 0 338

112.5 77 161 318 112 40 9 717

135.0 80 106 195 134 33 25 573

157.5 55 102 289 235 76 18 775

180.0 60 106 316 135 16 3 636

202.5 47 79 232 117 16 5 496

225.0 80 112 284 216 49 17 758

247.5 95 130 461 430 135 67 1,318

270.0 109 154 466 325 101 27 1182

292.5 74 85 217 124 60 16 576

315.0 81 92 134 48 4 0 359

337.5 55 69 112 53 6 0 295

Total 1097 1,380 3,335 2,107 582 187 8,688

Calms 72

Missing 0

Total 8,760

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Appendix B

Noise Assessment Report

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AWN Consulting Limited Registered in Ireland No. 319812 Directors: F Callaghan, C Dilworth, T Donnelly, T Hayes, D Kelly, E Porter

Cork Office Unit 5, ATS Building, Carrigaline Industrial Estate, Carrigaline, Co. Cork. T + 353 21 438 7400 F: + 353 21 483 4606

T: + 353 1 847 4220 F: + 353 1 847 4257 E: [email protected] W: www.awnconsulting.com

The Tecpro Building, Clonshaugh Business & Technology Park, Dublin 17, Ireland.

~ ::awn co nsu lti n g

_____________________________________

Technical Report Prepared For

Jacobs Engineering Merrion House 4 Merrion Road

Dublin 4

_____________________________________ Technical Report Prepared By

Dermot Blunnie BEng(Hons) MSc MIOA MIEI

_____________________________________

Our Reference

DB/18/10093NR01

____________________________________

Date Of Issue

26 November 2018

_____________________________________

REGENERON IRELAND

PRELIMINARY NOISE IMPACT ASSESSMENT FOR EPA LICENCE APPLICATION

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DB/18/10093NR01 AWN Consulting Limited _____________________________________________________________________________________________________

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Document History

Document Reference Original Issue Date

DB/18/10093NR01 26 November 2018

Revision Level Revision Date Description Sections Affected

Record of Approval

Details Written by Approved by

Signature

Name Dermot Blunnie James Mangan

Title Senior Acoustic Consultant Senior Acoustic Consultant

Date 26 November 2018 26 November 2018

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EXECUTIVE SUMMARY Regeneron Ireland U.C. (Regeneron) are currently extending their installation at Raheen, Co Limerick. As part of the IE Licence review application to the Environmental Protection Agency (EPA) an initial noise impact assessment must be undertaken and details in relation to noise emissions associate with the operation of the site submitted. This technical report has been prepared to provide details in relation to the noise impact assessment for the licence application. The assessment is based on the most up-to-date design details available for development and has been prepared with due consideration of the guidance contained within the Environmental Protection Agency (EPA) document Guidance Note for Noise: Licence Applications, Surveys and Assessments in Relation to Scheduled Activities (NG4) 2016. Section 6 of the EPA’s NG4 Guidance outlines the following assessment stages for the noise impact assessment for licence applications.

• Stage 1 – Baseline Noise Survey / Monitoring Locations;

• Stage 2 – Derivation of Noise Criteria;

• Stage 3 – Assessment of Noise Impact; and,

• Stage 4 – Reporting / Licence Application Form. This report has been prepared with consideration of the four assessment stages outlined above. To quantify the existing noise environment at the nearest Noise Sensitive Locations (NSL’s) to the site reference has been made to annual noise monitoring reports and survey data conducted in 2017 and 2018 for Regeneron. Appropriate operational noise criteria have been derived for the site which are based on the existing noise environment at the nearest NSL’s. The criteria identified is in line with current noise emission limits applicable at the Regeneron installation. To assess the impact of future noise emissions from the installation from both new and existing plant items at the nearest NSL’s, prediction calculations for plant items have been conducted in general accordance with ISO 9613: Acoustics – Attenuation of sound during propagation outdoors, Part 2: General method of calculation, 1996. The noise impact assessment has been completed using information obtained from the design team for significant items of new plant which are currently being procured from vendors. It is anticipated that where there is any substantial variation in the noise emission level of plant when installed on site (i.e. that has not been accounted for in the data used for this assessment), additional noise control measures shall be employed where necessary, to ensure that the operation of the installation will comply with the required noise criteria set out in this report or defined in the Licence issued by the EPA. The preliminary noise impact assessment has predicted that the installation will operate in compliance with the applicable noise criteria.

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CONTENTS Page

Executive Summary 3

1.0 Introduction 5

2.0 Fundamentals of Acoustics 6

3.0 Receiving Environment 7

3.1 Choice of Measurement Locations 7

3.2 Survey Periods 8

3.3 Measurement Parameters 8

3.4 Survey Results 8

4.0 Review of Relevant Guidance 11

4.1 Quiet Area Screening 11

4.2 Low Background Noise Area Screening 11

4.3 Current Noise Emission Limits 12

4.4 Determining Appropriate Noise Criteria 12

4.5 Compliance Noise Monitoring 13

5.0 Assessment 14

5.1 Noise Sensitive Locations 14

5.1 Noise Source Data 14

5.2 Calculation Methodology 15

5.3 Predicted Noise Levels 16

6.0 Conclusion 17

Figure 1 – Site Location & Context 5

Figure 2 – Level of Typical Sounds on dB(A) Scale 6

Figure 3 – Noise Monitoring Locations 7

Appendix I – Glossary of Acoustic Terminology 18

Appendix II – New Noise Emissions Table 20

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1.0 INTRODUCTION Regeneron Ireland U.C. (Regeneron) are currently extending their installation at Raheen Business Park, Co Limerick. AWN Consulting has been commissioned to prepare a noise impact assessment for the operation of the future installation to be compiled and submitted to the Environmental Protection Agency (EPA) as part of the Industrial Emissions (IE) licence review application process. This preliminary assessment is based on the existing noise emissions from the installation and the most up-to-date design details available for future development. The assessment has been prepared in accordance with the guidance contained within the Environmental Protection Agency in Relation to Scheduled Activities (NG4)”. There are two extensions at the installation which are covered by two separate planning applications and Environmental Impact Assessments Reports (EIAR’s). Please refer to Section 6.0 of the IE Licence review application. This report has been prepared in accordance with the four noise impact assessment stages outlined in Section 6.0 of NG4, which are as follows:

• Stage 1 – Baseline Noise Survey / Monitoring Locations;

• Stage 2 – Derivation of Noise Criteria;

• Stage 3 – Assessment of Noise Impact; and,

• Stage 4 – Reporting / Licence Application Form.

Figure 1 illustrates the proposed site location in the context of the surrounding environment with the approximate site boundary outlined in red.

Figure 1 Site Location & Context (Background Imagery Source: Google Earth)

The location of the proposed development is at the south and northeast of the site. Appendix I presents a glossary of the acoustic terminology referred to in this document.

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dB(A) scalo


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2.0 FUNDAMENTALS OF ACOUSTICS

In order to provide a broader understanding of some of the technical discussion in this report, this section provides a brief overview of the fundamentals of acoustics and the basis for the preparation of this noise assessment. A sound wave travelling through the air is a regular disturbance of the atmospheric pressure. These pressure fluctuations are detected by the human ear, producing the sensation of hearing. In order to take account of the vast range of pressure levels that can be detected by the ear, it is convenient to measure sound in terms of a logarithmic ratio of sound pressures. These values are expressed as Sound Pressure Levels (SPL) in decibels (dB). The audible range of sounds expressed in terms of Sound Pressure Levels is 0dB (for the threshold of hearing) to 120dB (for the threshold of pain). In general, a subjective impression of doubling of loudness corresponds to a tenfold increase in sound energy which conveniently equates to a 10dB increase in SPL. It should be noted that a doubling in sound energy (such as may be caused by a doubling of traffic flows) increases the SPL by 3dB. The frequency of sound is the rate at which a sound wave oscillates and is expressed in Hertz (Hz). The sensitivity of the human ear to different frequencies in the audible range is not uniform. For example, hearing sensitivity decreases markedly as frequency falls below 250Hz. In order to rank the SPL of various noise sources, the measured level has to be adjusted to give comparatively more weight to the frequencies that are readily detected by the human ear. Several weighting mechanisms have been proposed but the ‘A-weighting’ system has been found to provide one of the best correlations with perceived loudness. SPL’s measured using ‘A-weighting’ are expressed in terms of dB(A). An indication of the level of some common sounds on the dB(A) scale is presented in Figure 2. The established prediction and measurement techniques for the dB(A) parameter are well developed and widely applied. For a more detailed introduction to the basic principles of acoustics, reference should be made to an appropriate standard text1.

Figure 2 Level of Typical Sounds on the dB(A) Scale – (NRA Guidelines for the Treatment of Noise and Vibration in National Road Schemes, 2004)

1 For example, Woods Practical Guide to Noise Control by Ian Sharland.

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3.0 RECEIVING ENVIRONMENT This section deals with ‘Stage 1’ of the noise impact assessment as outlined in the EPA’s NG4 Guidance. The existing noise environment has been established through reference to annual environmental noise monitoring reports conducted by Regeneron as part of the condition of their existing Industrial Emissions licence (Licence No. P0991-1) from the EPA. Details of the surveys and results survey are presented in the following Section.

3.1 Choice of Measurement Locations

The site is bound on all sides by commercial and industrial development or lands zoned for such development. The nearest noise sensitive locations to the development site are the residential units located to the east and north of the site along Ballycummin Road over 400m from the proposed development. The next nearest receptors are the residential units located to the west of the site along the R526 over 600m from the proposed development. Figure 3 illustrates the proposed site boundary in the context of the two nearest NSL’s identified. NSL1(N1) Situated along the R526 to the west of the development site over 600m

from the proposed development.

NSL2(N2) Situated along the Ballycummin Road to the north of the development site over 400m from the proposed development.

Figure 3 Noise Sensitive Locations (NSL’s)

NSL 1

NSL 2

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3.2 Survey Periods

Noise measurements were conducted over the course of daytime, evening time and night-time periods as follows:

2017

• 13:38 to 17:52hrs on 6 March 2017

• 20:18 to 21:00hrs on 6 March 2017

• 01:42 to 02:50hrs on 7 March 2017

2018

• 15:26 to 16:56hrs on 6 February 2018



3.3 Measurement Parameters

The noise survey results are presented in terms of the following three parameters: LAeq is the equivalent continuous sound level. It is a type of average and is used to

describe a fluctuating noise in terms of a single noise level over the sample period.

LA90 is the sound level that is exceeded for 90% of the sample period. It is typically used as a descriptor for background noise.

LAFMax is the instantaneous maximum sound level measured during the sample

period.

The “A” suffix denotes the fact that the sound levels have been “A-weighted” in order to account for the non-linear nature of human hearing. All sound levels in this report are expressed in terms of decibels (dB) relative to 2x10-5 Pa.

3.4 Survey Results

NSL1

The survey results for Location NSL1 are summarised in Table 1 below.

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Year Period Start Time Measured Noise Levels (dB re. 2x10-5 Pa)

LAeq LAFMax LAF90

2017

Day

16:22 – 16:52 61 78 51

16:52 – 17:22 59 71 50

17:22 – 17:52 58 70 50

Evening 20:18 – 20:48 56 74 41

Night 01:42 – 02:12 46 75 32

02:12 – 02:42 49 71 33

2018

Day

15:26 – 15:56 67 79 53

15:56 – 16:26 67 81 56

16:26 – 16:56 69 97 57

Evening 20:52 – 21:22 62 78 45

Night 01:27 – 01:57 40 68 33

01:57 – 02:27 41 61 32

Table 1 Summary of Measured Noise Levels at NSL1

During daytime survey periods, the main sources of noise noted in the area was road traffic on the R526. Daytime noise levels were in the range of 58 to 69dB LAeq and 50 to 57dB LA90. No noise was attributed to Regeneron During the evening time survey period, the main sources of noise noted in the area was road traffic on the R526, distant road traffic noise from the M20 motorway and some pedestrian activity. Evening time noise levels were in the range of 56 to 62dB LAeq and 41 to 45dB LA90. The noise sources of significance observed during the night-time noise measurements were from road traffic noise and some faint plant noise. Night time noise levels were in the range of 40 to 49dB LAeq and 32 to 33dB LA90. No significant source of vibration was noted during the survey periods. NSL2

The survey results for Location NSL2 are summarised in Table 2 below.

Year Period Start Time Measured Noise Levels (dB re. 2x10-5 Pa)

LAeq LAFMax LAF90

2017

Daytime

13:38 – 14:08 60 74 51

14:08 – 14:38 60 78 52

14:38 – 17:08 60 73 51

Evening 20:30 – 21:00 56 76 45

Night-time

01:50 – 02:20 60 83 37

02:20 – 02:50 61 82 34

2018

Daytime

15:26 – 15:56 61 73 53

15:56 – 16:26 61 82 53

16:26 – 16:56 61 72 54

Evening 20:15 – 20:45 58 77 49

Night-time

01:40 – 02:10 49 71 42

02:10 – 02:40 44 69 40

Table 2 Summary of Measured Noise Levels at NSL2

During daytime survey periods, the main sources of noise noted in the area were road traffic on the Ballycummin Road and pedestrian activity. Other sources included

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birdsong. Daytime noise levels were in the range of 60 to 61dB LAeq and 51 to 54dB LA90. No noise was attributed to Regeneron During the evening time survey period, the main source of noise noted in the area was road traffic on the Ballycummin Road and distant traffic noise from the M20 Motorway. Evening time noise levels were in the range of 56 to 58dB LAeq and 45 to 49dB LA90. No noise was reported to be audible from Regeneron. The noise sources of significance observed during the night-time noise measurements were from road traffic noise. Night time noise levels were in the range of 44 to 61dB LAeq and 34 to 42dB LA90. No noise was reported to be audible from Regeneron. No significant source of vibration was noted during the survey periods.

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4.0 REVIEW OF RELEVANT GUIDANCE

This section deals with ‘Stage 2’ of the noise impact assessment as outlined in the EPA’s NG4 Guidance. The derivation of appropriate IE Licence noise emission criteria for the proposed installation will be conducted in accordance with the NG4 document. This approach is summarised below in accordance with guidance detailed in Section 4 of the NG4 document.

4.1 Quiet Area Screening The proposed development is not a quiet area as it fails to meet all the criteria outlined in EPA’s Guidance. The most stringent of these criteria are noted in bullet point and commented on below.

• At least 3km from urban area with a population >1,000 people; The site is located on the outskirts of the Limerick City suburb of Dooradoyle which has a population of greater significantly greater than 1000.

• At least 3km away from any local industry;

The current installation is operational, in addition to this there are serval industrial facilities within 3km of the site.

• At least 5km away from any National Primary Route; The site is located less than 1km from the M20 Motorway.

4.2 Low Background Noise Area Screening To establish whether the noise sensitive locations in the vicinity of the site would be considered ‘low background noise’ areas, the noise levels measured during the environmental noise survey need to satisfy all three of the following criteria:

• Arithmetic Average of LA90 During Daytime Period ≤40dB LA90, and;

• Arithmetic Average of LA90 During Evening Period ≤35dB LA90, and;

• Arithmetic Average of LA90 During Night-time Period ≤30dB LA90. The arithmetic average LA90 results at each location are compared against the criteria in Table 4.

Location Period Average LA90,15iin

(dB) NG4 Screening (dB LA90,15min)

Satisfies All Criteria for Low Background

Noise Area?

NSL1

Daytime 53 ≤40

No Evening 43 ≤35

Night-time 33 ≤30

NSL2

Daytime 52 ≤40

No Evening 47 ≤35

Night-time 38 ≤30

Table 4 Comparison of Measurement Results with NG4 Low Background Noise Area Criteria

As outlined in Table 4, none of the locations would be considered ‘Areas of Low Background Noise’ as the measured noise levels do not satisfy the criteria.

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4.3 Current Noise Emission Limits

The Regeneron installation is currently licenced to operate by the EPA under an existing IE Licence (Licence Register No.: P0991-1). Schedule B.4 state the noise emission limits which are applicable at the nearest NSL’s:

Daytime dB LAr,T (30 minutes)

Evening time dB LAr,T (30 minutes)


55 50 45Note 1


4.3.1 Compliance Assessment

Compliance noise monitoring was undertaken at the installation site in 2018. The monitoring was carried out by AXIS Environmental Services Ltd. Full survey methodologies and details are set out in the noise monitoring report issued by AXIS Environmental Services (Report Ref.:4210-18-01 dated 27 March 2018). This report concluded that Regeneron installation was operating in compliance with the noise limits set out in the site’s IE Licence.

4.4 Determining Appropriate Noise Criteria

Based on the EPA NG4 guidance the following noise criteria are appropriate at the nearest NSL’s to the installation:

• Daytime (07:00 to 19:00hrs) 55dB LAr,15-30 minutes

• Evening (19:00 to 23:00hrs) 50dB LAr,15-30 minutes

• Night time (23:00 to 07:00hrs) 45dB LAeq,15-30 minutes

During the night period, there shall be no clearly audible tonal or impulsive component to noise from the installation at any NSL. The noise criteria identified in this assessment are in line with the current noise emission limits values for the Regeneron installation. The NG4 Guidance allows for a relaxation of noise limits associated with emergency plant operations. Section 4.4.1 of EPA NG4 states the following in relation to emergency plant items:

“In some instances, licensed sites will have certain items of emergency equipment (e.g. standby generators) that will only operate in urgent situations (e.g. grid power failure). Depending upon the context, it may be deemed permissible for such items of equipment to give rise to exceedances in the noise criteria/limits during limited testing and emergency operation only. If such equipment is in regular use for any purposes other than intermittent testing, it is subject to the standard limit values for the site”.

It is therefore considered that the proposed noise criterion of 55dB LAeq,(15-30mins) is appropriate in emergency scenarios for daytime, evening and night-time periods.

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4.5 Compliance Noise Monitoring

See Attachment 7.5 of the Licence application for further details on the noise sensitive locations. If compliance noise monitoring is a condition of the IE Licence, the noise survey and assessment shall be undertaken in accordance with the guidance outlined in the EPA NG4 (2016) document and supported by a detailed noise report Measurement positions should be as close as possible to the position specified in the relevant licence conditions. If for any reason these positions are not accessible and/or are unsuitable, then alternative positions may have to be selected in consultation with the Agency.

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5.0 ASSESSMENT

This section deals with ‘Stage 3’ of the noise impact assessment as outlined in the EPA’s NG4 Guidance.

The noise levels expected at nearest NSL’s, due to the operation of the installation, must be considered and presented as part of the licence application. Due to the large distance between the Regeneron installation and the nearest NSL’s it is appropriate to base the noise assessment on predicted noise levels. The noise levels at the façades of the nearest noise-sensitive locations have been predicted for the worst-case scenario of the proposed installation being in continuous operation during both the day and night-time periods.

The following sections present details of the assessment and the preliminary findings.

The noise impact assessment has been completed using information obtained from the design team for significant items of plant which are currently being procured from vendors and information provided on existing operational plant items.

5.1 Noise Sensitive Locations

Noise prediction calculations have been carried out at the two nearest NSL’s to the site as previously identified, details of the NSL’s are presented in Table 5.

Noise Sensitive Location National Grid Reference (ITM)

North East

NSL1 554,766 652,825

NSL2 555,894 652,729

Table 5 Coordinates of Noise Sensitive Recievers

5.2 Noise Source Data The main new sources of noise on the site (with the exception of the east expansion) are listed in Appendix II of this document and location of all new and existing plant items on the site are shown in Drawings 008 to 010 of the IE Licence review application. In terms of noise sources there three elements to this assessment:

• Existing operation plant items; and,

• New Plant items for permitted, proposed and operational.

5.2.1 Existing Operational Plant Items

As outlined in Section 3.4, the existing Regeneron installation operates under an existing IE licence from the EPA, which defines operation noise emission limits for the installation. Annual noise monitoring carried out in 2018 has confirmed that the site is operating in compliance with the noise limits. For this assessment, reference has been made to the noise assessment undertaken for the installation in 2014 as part of the previous IE licence application submitted to the EPA (document reference IE0311171-22-RP-0008, Issue: A, dated 14 April 2014).

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5.2.2 New Operational Plant Items

There are several new plant items associated with the proposed and permitted development at the installation. Additional plant items have been commission on the site since the previous IE assessment in 2014 and these have been included as part of this assessment.

There are several items of noise generating equipment proposed for the new developments including the Administration and Laboratory Building (ALB) development and associated site changes. It has been assumed for this assessment that all plant items will operate 24 hours a day as a worst case and that all plant items have omni-directional noise emissions. The assessment considers all the major and minor noise sources of plant items that have been identified as having the potential to emit noise beyond the site boundary. The noise emission sources for the east expansion development are not known at this time as the detailed design for this aspect of the development has not yet progressed to that level of detail. To account for the potential impacts of potential noise sources associated with the permitted east expansion reference has been made to the noise impact assessment outlined in the relevant chapter of the EIAR completed as part of planning for the east expansion, as well as the EIAR completed as part of planning for the ALB and associated developments. Please see Section 6 of the IE licence application for copies of these reports. The details and location of all new noise emission points has been provided by Jacobs Engineering. Confirmation will be sought from the relevant suppliers at the detailed design stage that any significant noise producing plant items shall not emit total or impulsive characteristics to such a degree, that these characteristics could be audible at the noise sensitive locations. The objective of the noise impact assessment is to determine the expected cumulative noise emissions at the nearest noise sensitive locations for the existing and new operational mechanical plant items.

5.2.3 Details of Noise Control Measures

Control of noise will be considered as part of the detailed design of the new development at the installation. The principle of Best Available Techniques (BAT) as outlined in the NG4 Guidance shall be employed to control noise emissions and, where possible,

• external plant layout will utilise barrier screening of on-site buildings;

• low noise generating plant items will been selected;

• plant items will be located within fully enclosed plant rooms or ventilated plant enclosures louvred with attenuation;

• air handling units will be hard ducted to louvres or will have noise attenuation in series; and,

• all plant shall be selected such that there are no tonal or impulsive emissions.

5.3 Calculation Methodology

Prediction calculations for plant items have been conducted in general accordance with ISO 9613: Acoustics – Attenuation of sound during propagation outdoors, Part 2: General method of calculation, 1996.

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5.4 Predicted Noise Levels

This section presents the predicted noise levels at the nearest noise sensitive locations. It should be noted that as a worst case it is assumed that the new plant items are operating continuously during daytime, evening and night periods for normal operation. Noise prediction calculations do not take account of the acoustic screening that would be provided by off-site buildings located between the Regeneron installation and the NSL’s. Based on the source noise levels described in Section 5.2 and the noise source data included outlined in Appendix II the expected noise impact of the proposed installation on the nearest NSL’s outlined Table 5 has been calculated.

Table 6 presents the predicted noise levels at the nearest noise sensitive locations. It should be noted that as a worst case it is assumed that the plant is in operation continuously during daytime, evening and night-time periods.

Table 6 presents a breakdown of the predicted noise emissions from the site considering the operation of new (permitted and proposed) and existing plant items.

Location Existing operational Plant

Noise (dBA) New Plant Noise (dBA)

Total Operational Plant Noise (dBA)

NSL 1 35 37 39

NSL 2 32 41 42

Table 6 Predicted Operational Plant Noise Levels at NSL’s

Table 7 present the predicted plant noise emission levels at the nearest NSL’s and compares the results against the relevant criteria that have been derived for the site.

Receptor Predicted LAeq,15minute

Day (07:00 – 19:00hrs)

Evening (19:00 – 23:00hrs)

Night (23:00 – 07:00hrs)

Criterion dB LAr,T

Com

plie

s?

Criterion dB LAr,T

Com

plie

s?

Criterion dB LAeq,T

Com

plie

s?

NSL1 39 55

Yes 50

Yes 45

Yes

NSL2 42 Yes Yes Yes

Table 7 Predicted Operational Noise Levels vs Criteria

Backup generators may operate in emergency situations and for periodic testing during daytime hours. To reiterate, the NG4 document allows for relaxed noise emission criteria for emergency use equipment. Regardless of this fact, the worst case predicted noise emissions from the operation of the generators will be below the normal day, evening and night time noise criteria and any predicted increase in the noise emissions is expected to be not significant.

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6.0 CONCLUSION

In accordance with the relevant EPA NG4 Guidance, appropriate operational noise criteria have been derived for the site which are based on the existing noise environment at the nearest NSL’s. The criteria identified is in line with current noise emission limits applicable at the Regeneron installation. A noise impact assessment has been completed using information obtained from the design team for significant items of new mechanical plant and information obtained from previous noise assessments for the installation as detailed in Section 5.0. The assessment has found that the predicted noise emission levels at the NSL’s are below the day, evening and night-time noise criteria. Confirmation will be sought from the relevant suppliers at the detailed design stage that any significant noise producing plant items shall not emit tonal or impulsive characteristics to such a degree, that these characteristics could be audible at the noise sensitive locations. The preliminary noise impact assessment has been completed using information obtained from the design team for significant items of new plant which are currently being procured from vendors. It is anticipated that where there is any substantial variation in the noise emission level of plant when installed on site (i.e. that has not been accounted for in the data used for this assessment), additional noise control measures shall be employed where necessary, to ensure that the operation of the installation will comply with the required noise criteria set out in this report or defined in the Licence issued by the EPA. In conclusion, the preliminary noise impact assessment has predicted that the installation will operate in compliance with the applicable noise criteria as outlined below.

Daytime dB LAr,T (15-30 minutes)

Evening time dB LAr,T (15-30 minutes)


55 50 45Note 1


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APPENDIX I GLOSSARY OF ACOUSTIC TERMINOLOGY

ambient noise The totally encompassing sound in a given situation at a given

time, usually composed of sound from many sources, near and far.

background noise The steady existing noise level present without contribution from

any intermittent sources. The A-weighted sound pressure level of the residual noise at the assessment position that is exceeded for 90 per cent of a given time interval, T (LAF90,T).

broadband Sounds that contain energy distributed across a wide range of

frequencies. dB Decibel - The scale in which sound pressure level is expressed.

It is defined as 20 times the logarithm of the ratio between the RMS pressure of the sound field and the reference pressure of 20 micro-pascals (20 μPa).

dB LpA An ‘A-weighted decibel’ - a measure of the overall noise level of

sound across the audible frequency range (20 Hz – 20 kHz) with A-frequency weighting (i.e. ‘A’–weighting) to compensate for the varying sensitivity of the human ear to sound at different frequencies.

Hertz (Hz) The unit of sound frequency in cycles per second. impulsive noise A noise that is of short duration (typically less than one second),

the sound pressure level of which is significantly higher than the background.

LAeq,T This is the equivalent continuous sound level. It is a type of

average and is used to describe a fluctuating noise in terms of a single noise level over the sample period (T).The closer the LAeq value is to either the LAF10 or LAF90 value indicates the relative impact of the intermittent sources and their contribution. The relative spread between the values determines the impact of intermittent sources such as traffic on the background.

LAFN The A-weighted noise level exceeded for N% of the sampling

interval. Measured using the “Fast” time weighting. LAFmax is the instantaneous slow time weighted maximum sound level

measured during the sample period (usually referred to in relation to construction noise levels).

LAr,T The Rated Noise Level, equal to the LAeq during a specified time

interval (T), plus specified adjustments for tonal character and impulsiveness of the sound.

LAF90 Refers to those A-weighted noise levels in the lower 90

percentile of the sampling interval; it is the level which is exceeded for 90% of the measurement period. It will therefore exclude the intermittent features of traffic and is used to estimate a background level. Measured using the “Fast” time weighting.

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APPENDIX I GLOSSARY OF ACOUSTIC TERMINOLOGY (Continued)

noise Any sound, that has the potential to cause disturbance,

discomfort or psychological stress to a person exposed to it, or any sound that could cause actual physiological harm to a person exposed to it, or physical damage to any structure exposed to it, is known as noise.

noise sensitive location NSL – Any dwelling house, hotel or hostel, health building,

educational establishment, place of worship or entertainment, or any other facility or other area of high amenity which for its proper enjoyment requires the absence of noise at nuisance levels.

octave band A frequency interval, the upper limit of which is twice that of the

lower limit. For example, the 1,000Hz octave band contains acoustical energy between 707Hz and 1,414Hz. The centre frequencies used for the designation of octave bands are defined in ISO and ANSI standards.

rating level See LAr,T. sound power level The logarithmic measure of sound power in comparison to a

referenced sound intensity level of one picowatt (1pW) per m2 where:

0

10P

PLogLw dB

Where: p is the rms value of sound power in pascals; and

P0 is 1 pW. sound pressure level The sound pressure level at a point is defined as:

0

20P

PLogLp dB

tonal Sounds which cover a range of only a few Hz which contains a

clearly audible tone i.e. distinguishable, discrete or continuous noise (whine, hiss, screech, or hum etc.) are referred to as being ‘tonal’.

1/3 octave analysis Frequency analysis of sound such that the frequency spectrum is

subdivided into bands of one–third of an octave each.

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APPENDIX II NOISE EMISSIONS TABLE (PREVIOUSLY TABLE E.5(i))

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DB/18/10093NR01 AWN Consulting Limited ________________________________________________________________________________________________________________________________________________________________

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NEW NOISE EMISSIONS – Normal Duty Significant Noise Sources – Preliminary Noise Emission Summary

Source1

Emission point

Ref. No2

Equipment Ref. No

Sound Pressure

Level dBA at

reference distance3

Octave bands (Hz) Sound Power Levels dB(A) per band Impulsive

or tonal qualities4

Periods of Emission

31.5 63 125 250 500 1K 2K 4K 8K

AHU (FA Intake) NE-1 n/a 74 at 1m -- -- -- -- -- -- -- -- -- None Continuous

AHU (Exhaust) NE-2 n/a 77 at 1m -- -- -- -- -- -- -- -- -- None Continuous















Extract Fan NE-26 n/a 77 at 1m -- -- -- -- -- -- -- -- -- None Continuous












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Source1

Emission point

Ref. No2

Equipment Ref. No

Sound Pressure

Level dBA at

reference distance3

Octave bands (Hz) Sound Power Levels dB(A) per band Impulsive

or tonal qualities4

Periods of Emission

31.5 63 125 250 500 1K 2K 4K 8K





External Dx Condenser NE-60 n/a 61 at 1m -- -- -- -- -- -- -- -- -- None Continuous






Air Cooled Chiller NE-67 n/a 68 at 10m -- -- -- -- -- -- -- -- -- None Continuous

Air Cooled Chiller NE-68 n/a 68 at 10m -- -- -- -- -- -- -- -- -- None Standby

Pump NE-69 n/a 75 at 1m -- -- -- -- -- -- -- -- -- None Continuous

Pump NE-70 n/a 75 at 1m -- -- -- -- -- -- -- -- -- None Continuous

Cooling tower NE-71 n/a 66 at 10m -- -- -- -- -- -- -- -- -- None Continuous

Cooling tower NE-72 n/a 66 at 10m -- -- -- -- -- -- -- -- -- None Standby

Carbon Filter (WWTP) NE-73 n/a 79 at 1m -- -- -- -- -- -- -- -- -- None Continuous

Pump NE-74 n/a 74 at 1m -- -- -- -- -- -- -- -- -- None Standby



1. See Drawings No. 008 to 010 for the locations of all main noise sources on site.

2. Noise source emissions have been assumed from the preliminary noise impact assessments submitted as part of the IE Licence Application. See technical note ref.

DB/18/10093NR01 (Preliminary Noise Impact assessment for IE Application).

3. Preliminary noise emission data, as part of the detailed design process, acoustic attenuators, enclosures, silencers and louvres and barriers will be utilised where

appropriate to ensure that the noise emissions will not exceed the operational noise limits stipulated in the facilities EPA Licence.

4. It is understood that all noise sources will be continuous and broadband in nature. A tonal assessment has not been undertaken.

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Documents

Attachment 7.1.3.2 Impact Assessment of Emissions ...Agency’s (EPA) Licence Application Form Guidance – Industrial Emissions (IE), Integrated Pollution Control (IPC) and Waste