Attachment 1.2 Non-Technical Summary 1.0 INTRODUCTION · accompanied by an Environmental Impact Assessment Report (EIAR) prepared in compliance with the EU Directive on EIA. Planning

Regeneron IE Licence Review Application LA001739 AWN Consulting Limited _____________________________________________________________________________________________________

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Attachment 1.2 - Page 1

Attachment 1.2 Non-Technical Summary 1.0 INTRODUCTION

Regeneron Ireland UC (Regeneron) is applying to the Environmental Protection Agency (the Agency) for a review of its existing Industrial Emissions (IE) Licence (P0991-01) for its bio-pharmaceutical manufacturing installation in Raheen Business Park, Ballycummin, Raheen, Co. Limerick (See Drawing 1). The purpose of this licence review is to incorporate a number of proposed additional production, administration and laboratory functions along with a multistory car park into the existing IE licence. This will require the addition of a small number of major emissions points as well as changes to the licenced wastewater and stormwater emissions.

2.0 GENERAL INFORMATION 2.1 Planning Permission

In 2014 Regeneron was granted planning permission for conversion of the installation into a bio-pharmaceutical manufacturing installation (planning ref. 13/745). This application was accompanied with an Environmental Impact Statement (EIS) which has been supplied in Section 6 of this application. Planning permission for the east expansion (Planning Reference 17/1170) was granted by Limerick City and County Council (LCCC) on the 10th of April 2018. As such, construction works are currently underway at the site. This application was accompanied by an Environmental Impact Assessment Report (EIAR) prepared in compliance with the EU Directive on EIA. Planning permission for the ALB, MSCP and additional car park extensionswas granted by Limerick City and Council (LCCC) on the 12 April 2019.

2.2 Site Notice and Notifications of Application Intent

A site notice advising of the licence application has been erected at 6 no. locations around the perimeter of the Regeneron site. The notices will remain in place for one month after the date of submission to the Agency. Notification of the IE Licence Review application was also placed in the Irish Independent on 24 November 2018, and a letter was sent to the planning authority, LCCC, notifying them of the application on 26 November 2018.

2.3 Activities to be Licensed

The licensable activities, under the First Schedule of the Environmental Protection Agency Act 1992 are, Class 2.1: Combustion of fuels in installations with a total rated thermal input of 50 MW or more. And Class 5.16: Production of Pharmaceutical Products including intermediates

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Production, for the purposes of the activities mentioned in paragraph 5.12 to 5.17, means the production on an industrial scale by chemical or biological processing of substances or groups of substances mentioned in any of those paragraphs. The regulations do not define what is meant by ‘industrial scale’ however the proposed installation will be an industrial use.

No restrictions on capacity are outlined in the existing planning permission(s) for the installation.

2.4 Seveso III Regulations

Based on the information available for products used on site and corresponding usage and storage volumes, the EC (Control of Major Accidents Hazards involving Dangerous Substances) Regulations 2015 (S.I. No. 209 of 2015) do not apply to this site.

2.5 Medium Combustion Plant Regulations

Medium combustion plant directive (EU) 2015/2193 and the relevant monitoring and emission limit values will be regulated by the IE Licence.

3.0 DESCRIPTION OF SITE AND ACTIVITIES 3.1 Description of the Installation

The Regeneron installation is a multi-train, biopharmaceutical manufacturing facility and includes quality control laboratory and business support functions. The existing site layout is shown in Drawing 2 and includes the following areas:

• Core production building (consisting of 4 no. bulk biologics production trains, warehouse space and support utilities);

• Internal Warehouse;

• Clean Utilities Area;

• Quality Control (QC) laboratory;

• Administration Head block;

• Boiler room;

• Chiller room;

• Waste Management Yard;

• Wastewater Management System;

• South Utilities Yard;

• North Utilities Yard;

• Contractors compounds;

• Car parking areas; and

• Security gatehouse. The proposed new developments to the site are shown in Drawing 3 and include:

• single storey manufacturing extension designed for the phased construction of 3 to 4 no. manufacturing suites according to future needs and a new plant room area;

• new waste management area;

• external modular bunded chemical storage units;

• Administration and Laboratory Building (ALB);

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• Multi Story Car Park (MSCP);

• Additional mobile diesel fired generator and 2000L diesel tank (to be installed in 2019);

• Changes to the site’s stormwater drainage and attenuation;

• Additional open car park areas.

There are an estimated 750 personnel currently employed at the Regeneron site. In addition to this, there is ongoing supporting personnel such as temporary agency workers, contractors, external service providers, apprenticeships and interns and additional personnel including those visiting from other offices from the wider Regeneron company. It is anticipated that the ALB will provide capacity for between 400 and 600 personnel (depending on internal layout) once fully operational. For the purpose this licence review, an upper-case scenario of a total of circa 1,450 personnel is assumed to be on-site post-2020. Actual recruitment of personnel will be subject to personnel and business needs and approvals over time.

3.2 Hours of Operation

The installation currently operates 7 days per week, 24 hours per day. The additional production proposed as part of the east expansion will also run 24/7 and will provisionally start operation in 2020 with production ramping up over time to reach full capacity in 2022.

3.3 Environmental Management System (EMS) and Energy Management

Regeneron has an established Environmental Management System (EMS) which outlines the management of the site’s environmental program in a comprehensive, systematic, planned and documented manner. Whilst the installation is not accredited to ISO14001 it has adopted the principals of ISO14001 for the EMS. The EMS is reviewed and updated annually, as required, in accordance with the IE licence requirements. This sets out annual targets including targets for energy efficiency. The EMS will be updated to reflect the changes in the installation with the addition of the ALB and MSCP and the east extension once operational. The existing Regeneron installation has been designed to the highest possible standards for the biopharmaceutical industry and has incorporated energy efficiency design from the outset. Details on how the installation, both existing and proposed, comply with the BAT conclusions on energy efficiency is outlined in Attachment 4.7.3.

It should be noted that the proposed east extension and ALB will be modern, state of the art pharmaceutical facilities which have been designed in accordance with best practice. At the design stage, each unit operation has been assessed for energy efficiency and factors such as location of high electrical load items relative to supply connection point, sizing of electrical transformers etc have been incorporated into the design. The most notable units include process, heating, cooling, HVAC, motors/transformers, and lighting.

3.4 Structure and Personnel

The structure of the EHS department for the installation is detailed on the organizational chart in Figure 1. Whilst the entire leadership team has specific responsibilities for environmental and health & safety matters, the primary responsibility for the facilities maintenance and

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compliance with its IE licence rests with the installation Senior EHS and Security Manager who reports directly to the Senior Director of Engineering and Automation. The Senior EHS and Security Manager is supported by EHS Specialists. The Senior Director of Engineering and Automation reports to the Vice President and Site Head who has overriding responsibility for the site.

The Facilities Maintenance department, led by the Associate Director of Facilities Maintenance, also plays an important role in the implementation of the IE licence and its conditions.

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Occupational

Health SpecialistEHS Specialist

Director

Engineering & AutomationContractor

StaffSenior EHS & Security

Manager

EHS Manager

Environmental

Intern

EHS & Security

Supervisor

Senior EHS

SpecialistEHS Supervisor

Associate EHS Manager

Senior EHS

Specialist

EHS Specialist

Associate EHS Manager

Figure 1. EHS Organizational Chart

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3.5 Unit Operations

The installation in Raheen manufactures a variety of therapeutic proteins using biotechnology derived processes which are produced in a bulk or formulated state and are filled for shipping. The product candidates have the potential to help patients living with conditions ranging from rheumatoid arthritis and asthma to cancer and hypercholesterolemia. The primary process can be separated into Upstream and Downstream production. Upstream production consists of cell culture using bioreactors and harvest to produce a clarified cell ‘broth’. Downstream production takes the cell broth and captures the crude protein which undergoes purification and product formulation followed by filling. Figure 2 outlines the processes involved in primary production with upstream and downstream stages identified.

Figure 2 Process Flow Diagram for Regeneron Ireland Primary Processes

3.5.1 Inputs, Outputs and Throughputs

The primary installation processes and activities are summarised as follows: Inputs:

• Raw materials (including media-related and buffer powders for solution preparation);

• Frozen inoculum;

• Single Use items (bags, filters, pipes);

• Electricity;

• Gas;

• Water.

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Operations:

• Materials Sampling;

• Weigh / Dispense of raw materials;

• Medium Preparation;

• Buffer Preparation;

• Seed culture preparation (Upstream Manufacturing);

• Cell culture (Upstream Manufacturing);

• Harvest (Upstream Manufacturing);

• Protein Capture (Downstream Manufacturing);

• Purification and Viral Free Filtration (Downstream Manufacturing);

• Product formation and bulk fill (Downstream Manufacturing);

• Chromatography Column Packing;

• Clean in Place (CIP) of fixed equipment;

• Clean Out of Place (COP) in equipment parts washers;

• Autoclaving (Decontamination of Solid Wastes)

• Heat Inactivation (Decontamination of liquid bio-waste)

Outputs:

• Pharmaceutical products;

• Wastes;

• Wastewater.

3.5.2 Upstream (Cell Culture) Manufacturing This process includes seed culture preparation, cell culture and harvest. Step 1 – Seed Culture Preparation

The first operation involves preparation of the inoculum. Frozen vials, stored in liquid nitrogen freezers in the Warehouse, will be brought into the seed room and thawed. The culture or ‘working seed’ is combined with the filtered media in a biosafety cabinet then undergoes open cell expansion in an incubator room using a series of shaker flasks and wave tables. Once the growth period is complete the seed cell culture is transferred to the larger seed cell culture room on a cart.

In the seed room the flasks and wave bags are single use and are taken to the waste management area for autoclaving and disposal offsite as waste.

Step 2 – Cell Expansion The cell culture moves from the seed room to the bioreactor suite for cell expansion. This process is completed in a series of seed bioreactors (small, medium, and large) followed by production bioreactors. Growth media additions occur on a pre-determined schedule to support the growth of the cell culture at each of the different volumes. Cell expansion in the bioreactors does not produce any liquid wastes (under normal operating conditions); however, in the event of a spill or leak there are floor drains in place to collect the liquid waste and divert it to the heat inactivation system. These may also be used in the event of a faulty batch requiring disposal however the chance of this occurring is very unlikely.

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Atmospheric vents from the process equipment are fitted with sterile 0.2-micron vent filters to prevent any loss of biological material from the contained environment. These emission points are noted in the minor air emissions list in Attachment 7.4.2. Step 3 – Harvest The cell ‘broth’ from the bioreactors is transported via a closed operation to the harvest suite for cell culture harvest. The product is centrifuged to remove any suspended solids, passed through parallel depth filtration filters to remove cell residual cell debris, and transferred to the harvest tank for where it is piped to the capture suite. As with the bioreactor rooms, the harvest suites contain floor drains collected to the heat inactivation system. Liquid bio-waste from the centrifuge is also directed to the heat inactivation system. The harvest tanks are fitted with sterile 0.2-micron vent filters and are listed as minor emission points. All depth filtration filters are single use and there therefore sent to the waste management area for autoclaving before being disposed of as waste.

3.5.3 Downstream (Purification) Processing

Following harvest, the clarified cell broth is transferred to downstream processing for purification of the required protein. The includes capture, purification, product formation and bulk fill. The single use filters and solid wastes produced during downstream processes do not contain any GMO material and therefore will be sent to the Waste Management Yard for disposal. The liquid waste from the process is also produced and is collected in the process drain system and sent to the Wastewater Management System.

Step 1 – Capture

The purpose of this stage in the process is to remove the crude protein from the Clarified Cell Broth. The ‘Broth’ passed through a 3-round filter to the Protein A capture chromatography column where media is added. It then goes through a series of pool tanks for pH adjustment. Finally, the product batch passes through the Depth Filtration unit into a pool tank ready for transfer to the Purification Suite. All the corresponding pool tanks are equipped with tank vents abated with 2-micon filters.

Step 2 – Purification

The Purification stage further purifies the crude protein to produce the pure protein that can be further process for use in the pharmaceutical products.

Within the Purification Suite the product batch passes through a chromatography and a viral filtration step to remove any remaining impurities. All the corresponding pool tanks are equipped with tank vents abated with 2-micon filters.

Step 2a – Viral Free Filtration

As part of the Purification stage there is one Ultrafiltration and Diafiltration (UF/DF) suite per train. This process is used to concentrate the product, and condition and/or replace the buffer solution it is held within.

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The UF/DF process involves passing the pure protein product through a concentration vessel where buffers are added and then through a UFDF filter to produce the final product ready for formulation.

Step 3 – Product Formulation and Fill

In this final stage the product is mixed with formulation buffer and sterile filled into Polycarp bottle. These bottles are initially cooled in a -30°C freezer room and then frozen in a -80°C cascade freezer within the product storage area of the Warehouse.

3.5.4 Key Support Functions

The following operations occur as part of the main production processes. Materials Sampling Suite All raw materials, including flammables, are sampled within the materials sampling suite in the Warehouse prior to being used in the process. This suite is equipped with a fume hood with a HEPA filter.

Weigh & Dispense Suite

Raw materials (powders and liquids) and single use items will be received from the Warehouse and transferred to the Weigh / Dispense suite in the supplier containers using a dedicated self-bunded trolley. In the Weigh & Dispense Suite, key raw materials for the production line are transferred into smaller dedicated containers that can be used in the relevant suites.

Media Preparation Suites In the Media Preparation Suites, growth media solutions are prepared by mixing pre-purchased media powders with water in the media prep vessels on a batch by batch basis. The raw materials are charged manually into the top of the mixing vessels, and each tank has a dedicated local protection dust control system. The solutions are transferred to the bioreactors using single use bags, portable containers, or via permanent piping based on a predetermined schedule. The single use components are placed in designated bags or totes after use and are sent to the autoclave area or off site for treatment by dedicated waste vendor. Buffer Preparation Suites

In the Buffer Preparation Suites, buffer prep vessels are used for mixing buffer prep and supply solutions of inorganic salts and other solid raw materials with water. Raw materials are charged manually from the top into the prep vessels From the tanks the buffer solution is transferred directly to the Capture/Purification suites or into portable containers. Procedural controls are in place to ensure that all connections are closed. The buffer solutions are used for cleaning and conditioning of the chromatography resins and for containing the product in a stable solution during purification.

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Column Packing Prep and Staging Area Within the column prep and staging area, resin ‘sand’ is rehydrated with WFI in a 1000L resin slurry tank, which is pumped through a packing skid and into the columns chromatography. Any remaining slurry in the slurry tank is pumped into carboys on a floor scale, the WFI decanted off, and 20% ethanol re-added to the resin for storage. The carboys are then routed back to the Warehouse for storage. The 20% ethanol acts as a chromatography column storage buffer after cleaning the resin within the column.

Both Ethanol (70%) and Ethanol (20%) will be used in the future for the regeneration of chromatography resins sanitization step of the chromatography operation and for the storage of chromatography resins.

Cleaning in Place Systems All major processing equipment is cleaned using an automated clean in place (CIP) system. This involves rinsing with WFI followed by removal of solids using recirculating cleaning solutions. CIP cleaning solutions consist of a CIP caustic wash (0.2N caustic) and an acid rinse solution (0.5% phosphoric acid).

The resulting washwater from the WFI rinse is diverted to the heat inactivation system. The waste solution from the subsequent CIP cleaning cycles is diverted to the Wastewater Management System for onsite treatment and discharge to the foul sewer.

Equipment Parts Washer

Other equipment is cleaned out of place (COP) using the equipment parts washers. Each Equipment Wash Suite include 2 no. pass through style parts washers. The equipment undertakes a hot rinse (including detergents) in the parts washer and the resulting wastewater is diverted to the Wastewater Management System for attenuation and pH adjustment prior to discharge to the municipal sewer system.

Waste Decon Autoclave Contaminated components (e.g. empty bioreactor bags post use) will be placed within a Decon Autoclave which autoclaves the waste at 120°C to render it deactivated. The resulting waste is sent to the to the Waste Management Yard and packaged for offsite disposal. If the Decon Autoclave is not operational the Class 1 GMO waste can be transferred to the Waste Management Yard and sent off site to a dedicated vendor for treatment. Liquid wastewater (condensate) produced during autoclaving will be collected in a small, dedicated sump at the autoclave. The volume of wastewater produced is small and wastewater is routed to the installations wastewater drainage system for treatment in the Wastewater Management System. Heat Inactivation System All up streams drains, with the potential to hold GMO material, are routed via local dedicated bio-waste floor drains to a 12,000L sump and will be pumped to the Biowaste Treatment Area in the Warehouse for heat inactivation at 120°C. In the event that the entire contents of a bioreactor or excess inoculum need to be disposed of, this will also be treated in the bio-waste inactivation tank.

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The de-activated process wastewater is then sent to the cooling towers to cool the treated wastewater to a safe level so that it can be combined with the other process and utilities wastewaters in the Wastewater Management System for attenuation and pH adjustment prior to discharge to the municipal sewer system.

4.0 MATERIALS USE AND QUANTITIES

A list of all raw materials in use on the site is provided in Attachment 4.6.2. This list also includes chemicals which will employed at the site once the ALB and the additional utilities are operational.

4.1 Raw Materials Management

Raw materials and supplies are delivered to site by contractors/vendors. Shipments are delivered to the warehouse via the loading bay at the rear of the installation or to the bulk tanks directly. Driver procedures will be in place to ensure adequate care is taken during offloading of raw materials. Trolleys and carts will be used for all material movements within the installation. Separate trolleys/ carts will be used for the general circulation areas as opposed to the individual processing rooms. Each individual processing room will have dedicated trolleys/ carts which will stay within the relevant rooms and will only travel to the individual room Materials Air Lock (MAL) to receive materials. Single Use Mixers (SUM) and totes will also be used for movement of materials and single use components around the process areas. Trolleys used to transport hazardous chemicals are bunded. Bulk chemical storage external to the installation is bunded (or double skinned where applicable). In the event of a spillage, drainage from bunded areas shall be inspected and diverted for collection and safe disposal if required. 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 Agency’s 2004 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. Acids and bases with kept in separate stores. There is no potential for mixing of these chemicals and no risk of uncontrolled reactions. Spill kits are located across the site in highly visible and mobile units. These include absorbent socks, mats, pads, disposable bags, and PPE. Spill kits will be utilised in the event of a spill outside the designated bunds and staff are trained in the use of spill management materials. Staff are fully trained in site procedures, including all Standard Operating Procedures (SOPs) and emergency response and safety procedures in relation to the storage and handling of all substances being used at the installation.

4.2 Raw Materials Storage

The following chemicals are stored in the existing utilities yards:

• Bulk CIP chemicals (phosphoric acid and sodium hydroxide) in 25m3 bunded bulk tanks;

• Bunded diesel storage for the emergency generators (2 no. 55m3 bulk tanks);

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• Double skinned diesel tanks (2 no. 750L tanks) in the pump house;

• Process gases (N2, CO2 and O2) in bulk liquid gas storage tanks;

• Bunded 20% Ethanol storage tank (25m3);

• Assorted chemicals (lubricants, base, cooling water treatment chemicals, waste chemicals) within designated self-bunded chemstores (25L bottles to 200L drums);

• Nalco 93033 water treatment chemical stored in a bulk (750L) tank within the self-bunded chemstore adjacent to the cooling towers.

Whilst the bulk diesel tanks can hold up to 110m3 of diesel, a maximum of 50m3 is stored on site in the bulk tanks at any one time. The tanks are stored within a shared bund within a volume of c.105m3. The following chemicals are stored in the Wastewater Management System area:

• Acid (sulphuric) and caustic (sodium hydroxide) in double skinned tanks (20m3);

• Double skinned Chemiox (odour abatement) tank (10m3);

• Cooling tower treatment chemicals stored in chemstores (25L bottles to 200L drums);

• Antifoam IBC (1000L) in Chemstore

• Double skinned diesel tank (2000L) for the proposed mobile generator (to be installed in 2019).

As part of the proposed extensions (i.e. the ALB, East Expansion, and MSCP), the following chemicals will also be stored external to the buildings:

• Cooling water treatment chemicals within designated self-bunded chemstores (25L bottles to 200L drums);

• Liquid Nitrogen storage (max 4000L Liquid N2 tank) in the ALB yard; and,

• Possible caged bottle gas storage in the ALB Yard. Internal to the production building, the majority of the chemicals and raw materials are stored within designated areas in the Warehouse. This includes Isopropyl Alcohol (IPA) for decontamination of surfaces (pre-wetted wipes and IPA in spray bottles / canisters), Glacial acetic acid for buffer solution prep, media powders, flammable chrome media (on pallets), flammable resins (in a flammables cabinet), flammable corrosives, and single use items in sealed packaging. Flammables are segregated in accordance with the relevant legislation including the Safety, Health and Welfare at Work (Chemical Agents) regulations, SI 619 of 2001, as well as Health and Safety Executive (United Kingdom) guidance including HSG71 Chemical Warehousing: The Storage of Packaged Dangerous Substances and HSG51 The Storage of Flammable Liquids in Containers. Lab chemicals and supplies are also stored in smaller quantities within the QC Lab and will be stored in the ALB labs. Both the QC lab and the ALB labs will contain adequate storage for daily/weekly usage requirements. Refrigerants will be stored across the site within the chiller systems. These are stored in closed loop systems and will be topped up as required.

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5.0 WASTE Waste management is covered under Section 8 of this application. The proposed installation including the existing plant, the east expansion, and the ALB will give rise to a variety of waste streams from process and non-process related activities. The operations of the proposed development are expected to generate three main categories of waste – bio-hazardous, hazardous, and non-hazardous waste, as are currently generated by the existing installation. All documentation is retained on site in accordance with legislative requirements and the Environmental Management System for the site. Standard operating procedures have also been developed to cover waste management activities at the site.

5.1 Bio-Hazardous Liquid and Solid Waste Solid waste materials that have come into contact with biological materials are transferred periodically (typically once per shift) to the Warehouse for autoclaving as well as classification, labelling, bulking and removal off site. Single use components will be bagged within the manufacturing area and QC Labs and placed in bags or totes for transfer from the suites through material airlocks (MALs) or labs and taken to the dedicated decon autoclave for deactivation. After deactivation the waste is taken to the Waste Management Yard to be removed off site for final treatment. Biohazardous waste not deactivated on site is disposed to dedicated bins clearly labeled as bio-hazardous waste and sent off site through a dedicated vendor as per the installation’s GMO consent.

Process wastewater which may have come into contact with biological materials and/or off-spec bioreactor batches will be managed using a heat inactivation system prior to being discharged to the Wastewater Management System. Process wastewater which has not come in contact with biological material is collected in the various sumps and conveyed to the Wastewater Management System. Lab liquid waste that may have come into contact with biological materials is chemically deactivated within the specific labs and discharged to process drains which are conveyed to the Wastewater Management System.

5.2 Hazardous Liquid and Solid Waste Other hazardous (i.e. not bio-hazardous) solid wastes will also be generated in the production areas and lab areas. These include spent wipes and other consumables containing IPA, contaminated PPE, spent single use bags and filters (from downstream processes not containing bio-hazardous materials), etc. These will be bagged within the manufacturing area and QC Labs and placed in bags or totes for transfer from the suites through material airlocks (MALs) or from the labs and taken to Waste Management Yard for removal offsite for treatment in a waste to energy facility. Lab chemicals and liquid wastes not suitable for discharge to the sewer will be collected in suitable containers, properly labelled then transferred to the designated self-bunded chemical store (chemstore) in the existing Waste Management Yard to the north of the site.

Waste mineral and lubricating oil will be stored in labelled, sealed drums, and when full will be moved on a bunded pallet to the Waste Management Yard for removal offsite and disposal.

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Other hazardous solid wastes including fluorescent tubes, WEEE, batteries, etc. will be aggregated and stored in a designated storage location in the Waste Management Yard. Sharp wastes (hazardous and non-hazardous) will be collected and stored in yellow puncture-resistant sealable UN approved plastic containers, labelled contaminated or uncontaminated sharps, and will be transferred to the Waste Management Yard for collection by a third part specialist waste contractor. Sharps waste in contact with biological materials are autoclaved in the Warehouse (to be moved to the Waste Management Yard) prior to being sent offsite.

5.3 Non-Hazardous Wastes All non-hazardous waste is segregated for recycling/recovery/disposal at its source using dedicated bins located throughout the installation. Appropriate segregation of wastes at the source reduces the risk of cross-contamination and provides the greatest potential for recovery. Non-hazardous wastes allocated for disposal are sent to a waste to energy plant for recovery (no non-hazardous waste is disposed to landfill). Non-hazardous production wastes including unused bags, filters, etc. as well as packing elements will be segregated and stored within the Waste Management Yard prior to being removed offsite for recycling where possible, or disposal at a waste to energy facility. General waste will go to the designated compactor in the Waste Management Yard for offsite disposal. Food waste will be disposed of in the designated compost waste bins in the canteen and kitchenettes around the site. The compost waste bin is serviced on a regular basis by an approved waste vendor. Any solid waste that has been decontaminated in the autoclave can be disposed of as a non-hazardous waste stream.

6.0 BEST AVAILABLE TECHNIQUES

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; and

• BREF document on Best Available Techniques for General Principles of Monitoring, July 2003.

Please refer to Attachments 4-7-1 to 4-7-5 for detailed assessments of compliance with BAT for each of the above listed BREF and BAT guidance documents. It is concluded from this assessment that the installation will comply with the required best available techniques.

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7.0 EMISSIONS AND MONITORING

7.1 Emissions to Air

7.1.1 Boiler emissions There are 5 no. 7.23 MW natural gas fired boilers required for the generation of plant steam (previous application states 7.9 MW based on preliminary estimate of sizing). The boilers are in operation 24/7 with a typical arrangement of 3 boilers operating continuously with the other 2 on standby. The main emissions include combustion products from the ignition of natural gas. Each boiler has a stack height of 25m above ground level which is sufficient to ensure minimal impact on the ambient air quality in the vicinity of the site. The new east expansion will include 2 no. additional steam boilers. The boilers have not yet been purchased and will be up to 11.285MW (with a flow rate of up to 15,000 Nm3/hr). These will each have a stack height of 20m. A platform for sampling and associated power points etc. has been provided as per Agency’s guidance on sampling.

Within the existing installation there are also 2 no. 1.4 MW low pressure hot water (LPHW) boilers (previous application states 2.1 MW based on preliminary estimate of sizing). These were previously classified as minor air emission points; however, following the Medium Combustion Plant regulations, these will be re-designated as major air emissions. Monitoring of the LPHW boilers (A1-6 and A1-7) is not currently possible as there is no monitoring platform and there is limited space around the boiler stacks to safely collect a sample. As such, no monitoring is proposed, and this will be discussed with the relevant Agency enforcement officer.

7.1.2 Minor emissions Minor emissions consist of predominantly process ventilation emissions containing trace levels of contaminants. These include:

• CO2 and water vapour from the incubators and bioreactor units,

• water vapour and particulates from the BSCs,

• water vapour from the harvest tank vents,

• water vapour from the parts washer extract,

• particulates from the dispensing booth fume hoods,

• water vapour from the process waste and bio-waste tank and drain vents,

• water vapour from the boiler de-aerators,

• steam from the clean steam generator vents,

• water vapour from the cooling towers and WFI stills,

• trace solvents from the raw materials and lab fume hoods,

• media powders from the media prep vessel vents, and

• assorted trace levels of chemicals from the conservation vents on external tanks.

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. AHU units in non-process areas (e.g. canteen, non- airlock corridors, office spaces, warehouse, laboratory, etc) have not been included as minor emission points in the licence.

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The QC lab includes 1 no. natural gas fired 0.62MW boilers for steam (listed as A3-81) and a 0.54 MW hot water generation boiler (listed as A3-82) which are below 1MW and are therefore characterised as minor emissions rather than boiler emissions. The proposed east expansion may include 1 no. LPHW boilers (< 1MW) and the new ALB will have 2 no. LPHW boilers (0.5 MW), a steam generator (0.6 MW) and 2 no. water heaters (0.12 MW). These have been listed in Attachment 7.4.2.

7.1.3 Potential Emissions 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 generators will be tested periodically, approximately 1-2 hours every month, not exceeded 18 hours in any one year. These are fitted with a fixed unit meter (not manually adjustable) which tracks the no. of hours the generators operate.

7.1.4 Fugitive Emissions Fugitive emissions are defined as low level diffuse emissions, mainly of volatile organic compounds, that occur when either gaseous or liquid process fluids escape from plant equipment. There are no such emissions anticipated from the installation. External pipelines containing hazardous liquids will have flange guards. Gas pipelines are fully welded. 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. Other uses of solvent in the installation including ethanol for use in the regeneration and storage of 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.

7.2 Emissions to Sewer

Wastewater from the proposed developments will emanate from sources similar to the existing installation, these are; - 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;

- Domestic/foul effluent.

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Process and utilities wastewaters are treated in the Wastewater Managed Area prior to discharge to the Irish Water sewer along the north western boundary via licenced discharge point SE-1. The installation is currently licensed to dispose of up to 1,500m3 of wastewater per day. The proposed changes to wastewater under this licence review include an increased wastewater discharge into the municipal network up to 3,600m3 as well as changes to the Emission Limit Values (ELVs). These are presented in Section 7 of the IE licence application. Regeneron currently monitors the quality of wastewater discharged to sewer along the north western boundary via SE-1 in line with its IED Licence requirements, monitoring the performance of its effluent for pH, flow and temperature with a continuous monitoring system. BOD, COD, suspended solids, Total Kjeldahl Nitrogen, total phosphorus and sulphate are monitored monthly. A similar monitoring programme will continue once the new development is operational subject to agreement with the Agency.

As part of the IED licence (P0991-01) requirement, monthly monitoring of flow, physical and chemical parameters are measured at SE-1. There has been no result in breach of Regeneron’s licence requirement since operations began in 2015. All waste water will be discharged from the site (via Sewer Emission Point SE1) to the local council sewer which drains to the Bunlicky Waste Water Treatment Plant.

7.3 Emissions to Stormwater The existing on-site stormwater drainage network covers the entire built area of the site and collects rainwater runoff from yard areas, site roads, car park areas, and building roofs. Stormwater collected in the drainage network drains to a point in the north west corner of the site and discharges via a Class 1 by-pass petrol interceptor (c. 37,000L) into the main Raheen Business Park stormwater sewer at licenced emission point SE-2 (to be renamed SW-1). The drainage line is also equipped with an automatic pH-controlled pen-stock which will shut off the flow of stormwater if the pH exceeds the agreed trigger levels or in the event of sprinkler activation. It can also be closed manually locally at the unit. The drainage network around the south yard also includes 2 no. Class 1 full retention interceptors (10,000L each) as this area contains bulk diesel storage.

The storm water discharge from the Raheen Business Park stormwater sewer exits the estate and follows the route of a culvert and pipe to Loughmore Common Canal, which enters the Barnakyle River, which in turn flows into the Maigue River, which ultimately discharges to the River Shannon Estuary. As part of the proposed works, stormwater from the new ALB and parts of the new car parking area will be routed to a new underground attenuation tank located to the north west of the proposed installation, with adequate attenuation capacity of 1240m3. The outfall from the new attenuation tank will be equipped with a hydro brake to control the discharge rate to 4 l/s and an additional pH-controlled penstock for best practice. Stormwater from this drainage line will then discharge into the existing site drainage network via a new Class 1 by-pass petrol interceptor (190L) including a new silt trap (1200L).

Drainage from the multi-storey card park (MSCP) and surrounding car parks will drain to an engineered percolation area at new emission point SW-2. Drainage from the MSCP will be diverted to a 470m3 attenuation tank. Following the attenuation tank,

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the stormwater will subsequently drain via a hydro brake and a Class 1 by-pass interceptor (825L) including a sediment trap (5500L) to the single lined percolation area which also serves as a filter for sediment. The hydro brake will to control the discharge rate to 4 l/s.

Drainage from the new contractor’s carpark to the north east of the installation will drain via a silt trap (1500L) and a Class 1 by pass interceptor (225L) and to a new 180m3 single lined percolation area at new emission point SW-3. Continuous monitoring of pH, flow and temperature is in place for discharge 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 installation’s Licence.

7.4 Emissions to Surface Water

There are no emissions directly to a surface water body. 7.5 Noise Emissions

There will be several items of noise generating equipment operating on the site. These include the cooling towers, cooling tower pumps, chillers and condensers located external to the building. Other minor noise sources include the electric process water pumps, diesel fired firewater pumps and diesel fired emergency generators. The noise impact assessment included with Attachment 7.1.3.2 provides a list of the existing noise sources as well as the proposed noise sources for the ALB and associated site changes. Details of the noise sources for the east expansion are not yet know and details can be made available following detailed design of the extension. Annual day time, evening and night-time monitoring is undertaken at the installation in accordance with the existing IE licence requirements.

7.6 Emissions to Ground

There are no existing emissions points to ground from the installation. Proposed emissions of stormwater from the MSCP and the Contractors Compound will be discharged to an engineered percolation area via a hydrocarbon interceptor; however, these discharges have been considered under ‘stormwater emissions’. There are 4 no. existing groundwater monitoring wells (AGW-3, AGW-5, AGW-6 and AGW-7) which are monitored biennially in accordance with the existing licence requirements.

8.0 MITIGATION MEASURES/ABATEMENT

Regeneron will implement appropriate mitigation measures in order to protect the surrounding site environment and to follow regulations and limits set by legislation.

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8.1 Atmospheric Emissions

No specific abatement is in place for the air emissions. NO2 modelling results at the worst-case off-site receptor i.e., the highest NO2 concentrations measured off-site (including the site boundary) showed no significant impact. Modelling of the east expansion boilers using 11.285MW boilers has been included in the Unsolicited Information submission issued in April 2019. Controls include the SOPs that are part of the Environmental Management System for the installation. Existing air quality is well within the National and European Union (EU) air quality standards therefore no abatement system is required for the new main air emissions. For the proposed development, no specific abatement is required as the operational phase is predicted to have an imperceptible impact on ambient air quality and climate. In the case of 11.285MW boilers being installed at the east expansion, a restriction on the operational hours for all boilers will be applied in order to achieve acceptable levels of NOx. This will entail a restriction of 8000 operating hours per year for each of the main emission boilers. Minor emissions from preparatory and production vessels, emissions from fume hoods, autoclave vents, and low temperature 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.

8.2 Emissions to Wastewater

Abatement measures and monitoring are in place only for the process wastewater, whilst domestic effluent flows straight to the sewer. Process effluent generated during production may contain GMOs and therefore must undergo treatment to inactivate the cell culture. At the Regeneron installation this is undertaken using heat inactivation whereby the wastewater is treated at 120°C to kill any live cells. Following treatment, the wastewater is cooled using a bio-waste heat exchanger (the heat is passed to the pre-treated bio-waste) to minimise steam consumption and ensure the wastewater is safe to send to the Wastewater Management System. In the QC and ALB, the process effluent is chemically inactivated. All other process wastewaters including the decontaminated effluent will also require treatment in the Wastewater Management System prior to discharge. This involves flow balancing, cooling, and pH correction, and odour abatement. There are Standard Operating procedures in place for the wastewater monitoring at the installation.

8.3 Emissions to Stormwater

The current abatement technique for the stormwater network of the installation comprises all 1 no. stormwater emission points discharging to storm sewer via a Class 1 by-pass petrol interceptor (c. 37,000L). There are also 2 no. Class 1 full retention interceptors for the south yard as this area contains bulk diesel storage. The size of these interceptors is 10,000L.

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A penstock valve is in place prior to SW-1 which allows Regeneron to cease its stormwater discharge to sewer in the event of a major spill at the installation or an issue with the stormwater noted during monitoring. The pen-stock valve will close automatically based on continuous monitoring of the pH and / or on sprinkler activation and can be closed manually locally at the unit. 3 no. new Class 1 by-pass interceptors are proposed for the as part of the proposed upgrades to the surface water drainage network as follows; A new Class 1 by-pass interceptor (180l) and a silt trap (1200L) are proposed after the new attenuation tank and before the connection into the existing drainage network (which includes the existing c. 37,000L Class 1 by-pass interceptor). The outfall from the new attenuation tank will also include a pen-stock valve for best practice. 2 no. new Class 1 by-pass interceptors (825L and 225L respectively) are also proposed for the drainage lines from the MSCP and from the new contractor’s compound to engineered peculation areas. The MSCP drainage line will also include a 5500L silt trap. The percolation areas will use a WAVIN Aqua Cell system to provide infiltration and aerobic purification of the stormwater.

8.4 Noise Emissions

Where possible, external plant layout has utilised barrier screening of on-site buildings, low noise generating plant items have been selected, and noisy plant items have been located within buildings. Rooftop AHU’s are likely to have acoustic attenuators fitted as standard.

9.0 POLLUTION PREVENTATIVE MEASURES AND MEASURES TO MINIMISE 9.1 Minimisation of Emissions to Air

Measures are in place in accordance with BAT for the Manufacture of Organic Fine Chemicals and BAT for Common Waste Water and Waste Gas Treatment/Management Systems in the Chemical Sector. As part of the design of the new extensions (the east expansion, ALB, and MSCP) the project engineers identified a number of measures designed to limit emission sources, and improve integrity of process equipment and connections etc. Commissioning will be completed by vendors as part of the project – this will be overseen by suitably qualified engineers to ensure the required performance criteria are achieved. The main air emissions are from natural gas boilers which have comparably lower levels of greenhouse gas emissions than diesel fired boilers. The selection of the new boilers for the east expansion has taken into account the required emission limit values (ELVs) set out in the Medium Combustion Plant regulations as well as the need for high efficiency boilers at the site. Fugitive emissions from the use of IPA for cleaning and sterilizing of production surfaces is in accordance with Good Management Practices (GMP) practices. IPA will be stored internally in sealed spray bottles / cannisters and sealed wipes packaging in the Warehouse and in smaller cabinets in the production areas and laboratories until used. Following cleaning, and in the event of a shut down, spent IPA wipes and cloth wipes will be stored in sealed, flammable waste containers for

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disposal. Other organic solvents used at the installation including ethanol for use in the regeneration and storage of chromatography columns and Acetic Acid and 2-Propanol for use in solution preparation will be stored in sealed containers and will be dispensed directly from the container to the point of use in an air-controlled environment.

9.2 Minimisation of Emissions to Water

Measures are in place in accordance with BAT for Common Waste Water and Waste Gas Treatment/Management Systems in the Chemical Sector. Surface water drains and process water drains are segregated. Uncontaminated rainwater is collected and discharged to municipal storm water sewer rather than to foul sewer. In the Wastewater Management System, inactivated process wastewater, non-cell contact process wastewater and utilities wastewater is held in an equalisation tank system to smooth out any variations in the flow and pollutant loads. This allows a more uniform wastewater stream to be sent to the Irish Water municipal sewer.

9.3 Minimisation of Emissions to Noise

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 be 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. A noise management plan including noise monitoring will be outlined in the installation’s EMS.

9.4 Solid Waste Minimisation

Regeneron is committed to minimising the environmental impact of its operations and the proposed waste management process for the installation is considered an essential and integral component in the efficient operation of the installation. The entire production process has been designed with waste reduction in mind. The raw materials used in the pharmaceutical products produced at the site are extremely valuable therefore the minimisation of waste is crucial to the commercial success of the site.

Regeneron has an established Environmental Management System (EMS) which outlines the management of the site’s environmental program in a comprehensive, systematic, planned and documented manner. Whilst the site is not accredited to ISO14001 but has adopted the principals of ISO14001 for the EMS.

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The installation will also incorporate pollution prevention and waste minimization into projects and programs and track waste-reduction progress and resultant reduction in manufacturing costs. Regeneron will evaluate its chemical and raw materials list (see Attachment 4.6.2) at least annually to determine whether chemicals are unnecessary or unused and efforts will be made to minimize use of such chemicals in the future.

9.5 Pollution Prevention Measures 9.5.1 Bunds and Pipelines

All tanks, bunded storage and pipelines have been designed for its specific purpose and its contents. As required the structures will be rendered impervious to the materials stored therein.

The only underground pipelines are the treated process wastewater, foul sewer, and surface water lines. All process drainage is double contained. The foul and stormwater characteristics are as such that double containment is not necessary as per the Agency’s 2004 guidance on the storage and transfer of materials.

The majority of the bulk tanks are stored in bunds meeting the requirements of Agency guidelines on the “Storage and Transfer of Materials for Scheduled Activities”. Integrity testing will be completed in accordance with BS8007 “Code of Practice for design of concrete structures for retaining aqueous liquids” i.e. bunds will be demonstrated to be capable of holding 110% of the capacity of the largest tank or drum within the bunded area or 25% of the total volume of substances stored within the bund (whichever the larger). Additional bunds required for the ALB and the east expansion will be added to the bund register. All concrete bunds have local sumps which will be used to pump out uncontaminated rainwater to the wastewater management system. Collected rainfall is tested by site maintenance staff and, if clean and free from contaminants, it will be pumped out using a via a mobile pump. Tanks that do not require bunds, such as the firewater pump house diesel tanks, are double skinned and located adjacent to a hydrocarbon interceptor. Integrity testing of all concrete bunds and pipelines is carried out every three years in accordance with the existing IE licence.

9.5.2 Incident Management

In an event of a chemical spill or diesel spill to the storm water drainage system there is an Emergency Response Plan (ERP) in place to deal with such an event. A team of trained personnel, the Emergency Response Team (ERT), will respond to the incident in accordance with the ERP. The ERP also includes the training required to provide the ERT with the skills needed to address any environmental incidents. Spill kits are located across the site in highly visible and mobile units. These include absorbent socks, mats, pads, disposable bags, and PPE. Spill kits will be utilised in the event of a spill outside the designated bunds and staff are trained in the use of spill management materials.

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10.0 MANAGEMENT SYSTEMS

Regeneron has an established Environmental Management System (EMS) which The EMS outlines the management of the sites environmental program in a comprehensive, systematic, planned and documented manner. Whilst the site is not accredited to ISO14001 it has adopted the principals of ISO14001 for the EMS.

10.1 Emergency Response Plan (ERP)

An on-site ERP (Procedure ref. EHS4127) is in place at the installation and will be updated to include the ALB and the new east expansion areas. The ERP details the required response of the Regeneron emergency response personnel in the event of an incident on site and covers all possible emergency scenarios including fires, chemical spills, explosions, etc. The ERP will include arrangements for contacting the emergency services and those people in the surrounding environment that might be affected. The ERP is reviewed regularly by the EHS manager and is updated as required. It should be noted that the proposed installation will operate 24/7, 365 days a year. There is therefore no additional specific procedure required for emergencies outside normal working hours.

10.2 Standard Operating Procedures

Regeneron are an established bio-pharmaceutical installation with a number of SOPs in place for the prevention and management environmentally hazardous events. These include incident management, incident investigation, waste management, management of tanks/bunds/sumps, and management of chemicals. Further details can be found in Attachment 4.8.1 Operational Report.

The installation’s SOPs will be updated to accommodate the changes to the installation including the east expansion and the ALB.

11.0 COMPLIANCE 11.1 Air Emission Limits

As the installation falls within the scope of the Medium Combustion Plant Directive the emission limit values from Schedule 2 of the Directive apply. Schedule 2 specifies that natural gas boilers in operation before December 2018 must comply with the ELV of 200 mg/Nm3 for NOx whilst natural gas boilers in operation after December 2018 must comply with the ELV of 100 mg/Nm3 for NOx. The major emission steam boilers for the east expansion have a designed NOx emission value of 100 mg/Nm³ which complies with the more stringent ELV for boilers fuelled by natural gas in operation after December 2018. Whilst the 5 no. existing steam boilers are already in operation these are also able to meet the more stringent ELV of 100 mg/Nm³ for NOx. The existing steam boilers are monitored biannually in accordance with the existing licence requirements. An ELV of 100 mg/Nm³ for NOx is in place for the existing steam boilers. Monitoring undertaken since Regeneron operations started in 2015 indicate no exceedances of this limit (as reported in the 2015, 2016 and 2017 AERs).

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In the event that Regeneron install the larger 11.285MW steam boilers at the east expansion, a restriction on the annual operating hours will be required to ensure annual average ambient air quality limits are met for NOx. This restriction will be 8000 hours per year for each of the main emission boilers. There is a CO limit of 60 mg/Nm³ in place for the existing boilers. Monitoring undertaken since Regeneron operations started in 2015 also indicates no exceedances of this limit (as reported in the 2015, 2016 and 2017 AERs). The 2 no. new steam boilers to be installed at the east expansion will replicate the existing boilers and as such will be designed to meet this limit. The existing LPHW boilers were previously classified as minor air emission points and as such there has been no prior monitoring of these emissions. Regular monitoring of the LTWH boilers is not currently possible as there is no existing sampling platform and there is limited space around the boiler stacks to safely collect a sample. As such, no regular air monitoring is proposed as part of this licence review and this will be discussed with the relevant Agency enforcement officer. As these boilers are significantly smaller than the steam boilers, and will also run on natural gas, it is considered unlikely that they would exceed the existing limits for NOx and CO set out for the steam boilers. The emergency diesel generators will also be monitored in accordance with the directive. In accordance with Regulation 13 of the directive, the hours of use for the generators will be under the threshold limit and as such the emission limit values do not apply.

11.2 Sewer Emission Limits Attachment 7.3.1 outlines the nature of the proposed discharge including the relevant parameters. These values have been discussed at a high level with Irish Water and have been adjusted in accordance with those conversations. As such, it is considered that the revised ELVs will be adequate to ensure no detrimental impact on the Bunlicky WWTP. Monitoring of these parameters will be undertaken by a composite grab sampler and continuous flow monitoring (temperature, flow and pH) as outlined in the attachment. The relevant sectorial BAT instruments include the EU Decision BAT Conclusions for common wastewater and waste gas treatment / management systems in the chemical sector (2016) and the EU Reference Document on BAT for the Manufacture of Organic Fine Chemicals (2006). Both documents provide ELV’s for discharges from a biological waste water treatment plant to a waterbody. As the wastewater from the installation will be treated offsite in Limerick City and Environs Wastewater Treatment Plant (WWTP) at Bunlicky, Co. Limerick, these limit values have been addressed in Attachment 7.3.2 Equivalent Level of Protection.

11.2.1 Equivalent Level of Protection

The Bunlicky WWTP 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.

As outlined in Attachment 7.3.2., the ELVs set by the Bunlicky WWTP discharge licence comply with the relevant BAT AELs from the Sectorial BAT document,

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namely the EU Decision BAT Conclusions on Waste Water and Waste Gas Treatment / Management Systems in the Chemical Sector, with the exception of TKN. As TKN is not a parameter covered under the Bunlicky WWTP discharge licence, a separate assessment was undertaken to look at the capacity for nitrogen removal at the WWTP. This assessment concluded that based on the level of dilution that the Regeneron effluent with receive and the nitrogen reduction efficiency of the Bunlicky WWTP (based on the 2017 AER) the resulting concentration of the Regeneron effluent after offsite treatment will be between 12.7 mg/m3 (average) and 15 mg/m3 (peak) which is compliant with the BAT AEL.

11.3 Stormwater Emissions

In accordance with BAT, clean stormwater will be kept separate from wastewater and there will be no inherent risk of cross-contamination. Stormwater run-off will be from buildings and car parks only and therefore there is no requirement to undertake regular sampling of the stormwater prior to discharge. Weekly visual inspections will be undertaken for all stormwater discharge points in accordance with the installation’s IE Licence. Due to the nature of the run-off from the existing installation (stormwater from buildings and roads only) and the inclusion of hydrocarbon interceptors, the proposed discharge is unlikely to contain more than trace hydrocarbons and metals. Where bulk diesel storage is proposed for the proposed installation, the existing Class 1 Full Retention interceptors will provide additional protection. It is not anticipated that the surface water quality will exceed the Environmental Quality Standards as set out in SI 272 of 2009 and SI 386 of 2015 (Surface Water Regulations). 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. The installation has set trigger levels for the stormwater discharge from SW-1. In the event that an exceedance is noted during continuous monitoring the discharge ceases. No discharge of contaminated stormwater at SE-1 (to be re-named SW-1) has occurred previously since Regeneron started operations. The discharge from the new attenuation tank at SW-1 and new attenuation tank at the MSCP will have a controlled discharge of 4 l/s via restricted gravity flow. There is no relevant limit for flow; however, the proposed rates of discharge have been designed to have minimal impact on the hydrology of the stormwater sewer.

11.4 Noise Emissions

The Regeneron installation is currently licenced to operate by the Agency under an existing IED 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)

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.

Compliance noise monitoring was undertaken by AXIS Environmental Services Ltd at the installation site in 2018. The noise monitoring report concluded that Regeneron

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installation was operating in compliance with the noise limits set out in the site’s IED Licence. A noise impact assessment was undertaken as part of this licence review and is included with Attachment 7.1.3.2. This report provides a list of the existing noise sources 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 was 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. The objective of the noise impact assessment was to determine the expected cumulative noise emissions at the nearest noise sensitive locations for the existing and new operational mechanical plant items. Prediction calculations for plant items were conducted in general accordance with ISO 9613: Acoustics – Attenuation of sound during propagation outdoors, Part 2: General method of calculation, 1996. 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. These calculations showed that the predicted cumulative noise level would be up to 42 LAeq at the nearest noise sensitive locations during night time periods. The results of the preliminary noise impact assessment therefore indicate that the installation, including the existing and new noise sources, will operate in compliance with the applicable noise criteria as outlined in the existing IE licence.

11.5 Groundwater Protection

As part of this assessment, consideration has been given to EU Council Directive 2006/118/EC in relation to the protection of groundwater. The 2006 Directive establishes specific measures as provided for in EU Council Directive 2000/60/EC in order to prevent and control groundwater pollution. The Directive also complements the provisions for preventing or limiting inputs of pollutants into groundwater already contained in Directive 2000/60/EC and aims to prevent the deterioration of the status of all bodies of groundwater.

Under the 2006 Directive, the Member States must also establish the chemical status of each groundwater body in accordance with the European Communities Directive 2000/60/EC (commonly known as the Water Framework Directive [WFD]) and must undertake measures to protect groundwater defined as having ‘Good Water Status’ whilst also moving to achieve ‘Good Water Status’ in all other groundwater bodies. The Groundwater Body (GWB) underlying the site is Limerick City Southwest. Currently, the Agency’s on-line mapping (Envision) classifies the Limerick Southwest body as having ‘Poor Status’, with a WFD risk of not achieving good status. Groundwater samples are collected and analysed on a biennial basis (i.e. every 2 years) in compliance with Regeneron’s IED 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. In 2016 groundwater samples were collected from the four onsite wells, AGW1, AG2, AG3 and AG4. The locations of these wells can be seen in Attachment 4.8.3. The

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results showed no exceedances above the available GTVs for PCB’s, pesticides, VOCs, sodium, total PAH’s and glycols. Due to ongoing works on the site three new wells have been installed (AGW5, AGW6 and AGW7) these are now reported with AW3 in compliance with the sites IED Licence. These boreholes were sampled in September 2018. All samples analysed for DRO, PCBs, Pesticides, VOC’s & PAH’s were either below the LOD or below the relevant GTVs. Some inorganic compounds, chloride and Total Ammonia did have elevated readings which are likely due to presence of suspended solids in the samples following recent drilling. There will be no direct discharges of contaminated water to groundwater or soil environment during the operation of the installation, and 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.

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 status of the Limerick City Southwest GWB from the site operations. Based on the existing monitoring results it is anticipated that the site operations will not result in exceedances in the GTVs. The installation is therefore considered to be compliant with the relevant Directives on groundwater protection.

12.0 EXISTING ENVIRONMENT 12.1 Hydrological Environment

The closest surface water feature to the installation is the 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. The River Shannon is located approximately 4.0 km northwest of the installation with the Lower River Shannon Tributary approximately 3 km to the northeast of the installation. The Limerick City & Environs Municipal WWTP located in Bunlicky, which will receive and treat wastewater from the Regeneron site, discharges treated effluent within the tidal reach of the River Shannon at the eastern limit of Limerick City. This stretch of the river is within both the Lower River Shannon cSAC and the River Shannon and River Fergus Estuaries SPA. The Agency’s 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. From a review of the Agency’s on-line Envision database, the most up-to-date status (River Waterbody WFD Status 2010-2012) of the river Barnakyle is Poor. The Barnakyle River is also classified as being ‘at risk of not achieving good status’. 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 developments (Planning reference 18/1098). The purpose

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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. 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).

12.2 Soils, Geology and Hydrogeology

The current condition of the Regeneron installation 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. The soil type located at the proposed development is predominantly classified by the GSI (2017) as tills derived from the underlying limestone and made ground. 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.

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.

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.

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.

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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. The Groundwater Body (GWB) underlying the site is Limerick City Southwest. Currently, the Agency’s on-line mapping (Envision) 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.

12.3 Ambient Air Quality

Air quality monitoring programs have been undertaken in recent years by the Agency and Local Authorities. The most recent annual report on air quality, “Air Quality Monitoring Annual Report 2016” (EPA, 2017), details the range and scope of monitoring undertaken throughout Ireland. With regard to NO₂, monitoring data from the Agency at the Zone C locations, the

relevant zone to Raheen, in 2016 showed that the annual average NO2 levels were a maximum of 11 μg/m3, 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. 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.

12.4 Existing Noise Environment

The existing noise environment has been established through reference to annual environmental noise monitoring reports conducted by Regeneron as part of the conditions of existing Industrial Emissions Licence No. P0991-1. Details of the surveys and the results survey are presented in Section 3 of the noise assessment which is provided with Attachment 7.1.3.2.

13.0 PREDICTED IMPACTS 13.1 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. Air dispersion modelling was carried out using the United States Environmental Protection Agency’s regulatory model AERMOD (Version 16216r). The purpose of

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this modelling study is to determine whether the major (boiler) emissions from the site will lead to ambient concentrations that are in compliance with the relevant ambient air quality standards for Nitrogen Oxides (as NO2). A revised model was undertaken for the larger boilers proposed for the east expansion, and this has been provided with the Unsolicited Information submission issued in April 2019. The results indicate that the ambient ground level concentrations are below the annual and 1-hour ambient air quality standards. Emissions from the facility lead to an ambient NO2 concentration (including background) which is 58% of the maximum 1-hour limit (measured as a 99.8th

percentile) and 76% of the annual limit at the worst-case off-site location for the worst-case years modelled (2014 and 2017 respectively). Results are also in compliance with the acceptable maximum permissible process contribution as outlined in EPA Guidance Note AG4. 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. Dust is also a Principle Pollution Substance and as such careful controls are in place to prevent emission of powders into the air. The weigh and dispense suites and media preparation suites include a localised downflow HVAC with low air returns to ensure dust from powders will be minimized and contained. 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. Other Principle Pollution Substance of concern (see S.I. No. 283/2013) including Volatile Organic Compounds (VOCs) are not relevant to the installation as solvents are only used in small quantities in production (i.e. Acetic Acid). Solvents used in cleaning (i.e. Isopropyl Alcohol (IPA)) will stored in sealed wipes packaging and sealed bottles in the Warehouse until used. IPA impregnated wipes and spray bottles will be used for cleaning work spaces and used wipes / cloths will be put in flammable waste containers for disposal. There is no exhaust gas collection and all air vents from process areas (non-exhaust gases) will have non-return valves. The impact of the proposed developments in terms of air quality impact from traffic emissions is presented in the EIAR for both the east expansion, submitted with planning application the east expansion Reference 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. Both chapters concluded that there will be no impact on air quality from traffic emissions as a result of the development. In terms of climatic impacts, on-site emissions of CO₂ and other greenhouse gases

are not expected to be significant in terms of Ireland’s national emissions and Ireland’s agreements under the Kyoto Protocol and other climate strategies. CO2 in the boiler emissions is monitored in accordance with the existing IE licence. The diesel generators, whilst being a potential source of greenhouse gases, will only be in use during emergency operations i.e. when there is a power outage from the national

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grid. Thus, given the likely very low usage of the emergency generators, the likely on-site emissions of greenhouse gases will not be significant.

13.2 Sewer

Operation of the plant will be according to BAT (Best Available Technology) 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). S.I. No. 283/2013 - Environmental Protection Agency (Integrated Pollution Control) (Licensing) Regulations 2013, lists a number of Principle Pollution Substance including:

11. Substances which contribute to eutrophication (in particular, nitrates and phosphates). 12. Substances which have an unfavourable influence on the oxygen balance (and can be measured using parameters such as BOD, 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. There is no potential for biological material to leave the installation through the wastewater streams as processes are closed and process wastewater from cell culture and harvest/depth filtration will be treated via a heat inactivation skid prior to being combined with ‘clean’ process wastewater and utilities wastewater in the Wastewater Management Area. Wastewater will be discharged after flow balancing and pH neutralisation to ensure no impacts on the sewer network. After onsite treatment, the industrial wastewater will be discharged from the site to the municipal sewer which drains to the Bunlicky WWTP. Pre-application discussions with Irish Water have been undertaken on the capacity of the WWTP to accept the proposed volume of wastewater. Irish Water advised during these high-level discussions that the receiving wastewater treatment facility should have the capacity to accept the proposed discharge should adjustments to the ELVs be made. These comments have therefore been incorporated into the proposed ELVs as presented in this licence review application.

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 WWTP’s Annual Environmental Reports (AERs), and there are no current known restraints on the capacity of this plant. Ambient water quality monitoring undertaken by Irish Water over the past 4 years, under the requirements of the Bunlicky WWTP discharge licence, has indicated that the water quality downstream from the Bunlicky WWTP discharge has typically been compliant with the relevant Environmental Quality Standards (AERs 2014- 2017).

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As such, it is anticipated that the Bunlicky WWTP will be sufficient to appropriately treat all wastewater discharges from the Regeneron installation including Principle Pollution Substance of concern (see S.I. No. 283/2013) relevant to the installation including organophosphorus compounds, suspended solids, BOD, COD, and nitrogen compounds.

13.3 Surface Water For the purposes of this assessment, the receiving environment is considered to be the Barnakyle River; however, this will ultimately have implications for the River Shannon Estuary as well. Whilst the overall quality of the existing surfacewater environment in the vicinity is poor, the proposed development will not have a significant impact on the quality of the receiving surface water bodies as further discussed in Attachment 7.1.3.3 Receiving Environment Report. Stormwater run-off from buildings and car parks will be kept separate from wastewater and there is no inherent risk of cross-contamination. The only relevant Principle Pollution Substance of concern, with regards to S.I. No. 283/2013 - Environmental Protection Agency (Integrated Pollution Control) (Licensing) Regulations 2013, is hydrocarbons. As outlined above, there are a number of robust measures in place at the installation to prevent diesel entering the stormwater network including the use of bunds and hydrocarbon interceptors, as well as the availability of trained personnel to manage leaks and spills. There is also a pH-controlled penstock in place at SW-1 which will allow 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. 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). Furthermore, the 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. Whilst 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. The provision of attenuation and the use of a hydro brake at SW-1 to control the rate of discharge is sufficient to prevent flooding at the Barnakyle River as a result of the Regeneron stormwater runoff. The attenuation tanks have been sized in accordance with the area of drainage and the predicted rainfall volumes and is sufficient to accommodate a 1 in 100-year return period design rainfall event. As such, the proposed development will not have a noticeable impact on the hydrology of the receiving environment and will not result in increased flooding downstream of the site.

13.4 Noise

To assess the potential noise impact of the proposed plant items, a preliminary noise impact assessment incorporating the existing operation plant and the proposed new

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plant items has been prepared. This has been carried out 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. The results of the noise assessment are presented in Attachment 7.1.3.2. 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. It was assumed for the 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 considered 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 preliminary noise assessment calculated that operational noise will be within the relevant day time and night time limits at the nearest noise sensitive receptors. This is consistent with the EIAR for the ALB and MSCP which 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. Backup generators may operate in emergency situations and for periodic testing during daytime hours. Whilst the NG4 document allows for relaxed noise emission criteria for emergency use equipment, the worst case predicted noise emissions from the operation of the generators will also 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 impact of noise from additional vehicular traffic on public roads was also assessed as part of both 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.

In summary, the noise or vibration effects are not expected to affect the sensitivities of the receiving environment and will be compliant with the relevant day time and night time limits.

13.5 Groundwater

There will be no direct discharges of contaminated water to groundwater or soil environment during operation.

The only known emission to ground will be the stormwater from the new MSCP and the surrounding open car park areas and from the proposed contractors’ car park which will drain to new percolation areas via Class 1 by-pass hydrocarbon interceptors and combined silt traps.

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The only potential pollutants are therefore hydrocarbons (from the vehicles) and sediment. These will be removed by the interceptor and the silt trap prior to discharge.

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. As such, the risk of contaminants entering the ground and groundwater environments is low. As such, it is considered that other than those parameters that are naturally 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 Agency’s 2003 Interim Guidelines.

13.6 Cross-boundary Impacts

There are no anticipated impacts over long distances or outside the territory of Ireland as a result of the proposed changes onsite. All proposed air emissions and monitoring will be compliant with ambient air quality standards and will not have a transboundary impact. All proposed sewer emissions and monitoring will not result in transboundary impacts on the downstream wastewater treatment plant. All other changes are minor and will have negligible impacts on the environment as a whole.

14.0 RISK MANAGEMENT AND LIABILITY 14.1 Risk Management

In terms of risk management, the installation will operate to a wide variety of Standard Operating Procedures (SOPs). These include SOPs on spill prevention and control, incident investigation & reporting, hazard identification and risk assessment, and transfer and storage of materials and wastes. An on-site Emergency Response Plan (ERP), Procedure ref. EHS4127, is in place at the installation and will be updated to include the ALB and the new east expansion areas. The ERP details the required response of the Regeneron emergency response personnel in the event of an incident on site and covers all possible emergency scenarios including fires, chemical spills, explosions, etc. The ERP will include arrangements for contacting the emergency services and those people in the surrounding environment that might be affected. The plan also includes the training required to provide the ERT with adequate skills. The ERP is reviewed regularly by the EHS manager and is updated as required.

14.2 Fire Management

The existing installation is equipped with automated fire detection systems (heat and smoke) as well as natural gas detection systems in the Main Boiler House, Headblock Boiler House, and the QC Plant Room, oxygen depletion detection in the

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Cryo rooms, and CO2 monitoring in the seed area. These are connected to a main fire panel in the security office which is manned at all times. In the event that a fire is detected, the fire panel will display the location of the detected fire; and in the case of a detected fire within the main production building, then the specific production line will also be indicated. Once detected the location of the potential fire will go into an alarm state and, in the event of a production area fire, production will cease, and process kit will be left ‘as-is’. Gas supply systems to the production areas will also cease. The fire detection and alarm systems are connected to the sprinkler and gas suppression systems and these will be triggered in the event of a fire. The automated fire detection system will be expanded to include the east extension and ALB as they are developed. The fire detection and alarm systems are subject to routine checks by Regeneron personnel and is inspected and tested by the external service provider on a regular basis.

Firewater retention assessment is currently being completed for the installation. The preliminary report indicates no requirement for additional firewater retention.

14.3 Out-of-hours and Abnormal Circumstances

It should be noted that the proposed installation will operate 24/7, 365 days a year. There is, therefore, no additional specific procedure required for emergencies outside normal working hours.

14.4 Site Closure and Liability

A Closure, Restoration and Aftercare Management Plan (CRAMP) and Environmental Liabilities Risk Assessment (ELRA) will be submitted for the enlarged installation as required following commencement of the new operations. These documents will be prepared in accordance with the Environmental Protection Agency’s Guidance on Assessing and Costing Environmental Liabilities (2014). Under the requirements on the existing IE Licence, Regeneron undertake an annual review of the CRAMP and ELRA and report on this in its Annual Environmental Report.

15.0 ALTERNATIVES 15.1 Process alternatives

Alternative site locations and site designs are covered in the relevant chapter of the EIAR. In terms of alternative methods for the manufacture of biopharmaceutical products, there are two options available: fixed stainless-steel vessels for cell growth, harvest, and purification or single use bag technology. The use of fixed vessels means the equipment will be re-used on a weekly basis for batch production. Fixed systems involve higher start-up capital but lower running costs once operational, and using fixed systems also requires less energy to run and produces less solid waste. However, as the production equipment requires frequent cleaning and validation between campaigns there is a greater water requirement. Single use technology has been gaining popularity in recent years as it has a significantly lower water requirement and reduces the need for cleaning. However, by

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its nature single use technology also produces a significant amount of solid (plastic) waste which requires autoclaving and offsite disposal. The Regeneron installation chose to employ fixed stainless-steel vessels for its production trains when it was established in 2014 due to both the energy and waste saving benefits as well as the long-term cost benefits for the installation. Single use parts have been employed where environmentally friendly.

15.2 Abatement Alternatives

15.2.1 Bio-Waste Abatement

In terms of alternatives for bio-waste abatement, there are two main options for the inactivation of bio-hazardous liquid waste. These are heat inactivation and chemical inactivation. Both methods of inactivation can be applied to Class 1 GMO facilities. However, heat inactivation is more efficient for large batches and therefore has been selected over chemical inactivation at the Regeneron installation due to the size of the operations. Whilst this option has a greater energy requirement than chemical inactivation it reduces both the amount of wastewater produced and the pollutant load of the wastewater (i.e. no additional chemicals added). Once treated and cooled the wastewater can be diverted to the municipal sewer and will not require further treatment (other than simple pH adjustment) to remove or dilute chemical constituents. Chemical inactivation will be used in the ALB and the QC as the volumes of product produced in these areas are not significant.

15.2.2 Wastewater Abatement

The final treatment of a wastewater stream can either occur onsite, in an onsite Wastewater Treatment Plant (WWTP), or offsite in the municipal WWTP. The rationale for selecting the appropriate option is based on both the availability of a municipal WWTP within the vicinity of the site that the installation can connect to, and the nature of the wastewaters produced at the installation and its suitability for treatment in the municipal WWTP.

The Regeneron installation has an established connection to the Irish Water sewer and is located within close proximity of the Bunlicky WWTP. The wastewater from the existing installation is characterised by low to medium strength BOD/COD, high nitrogen, high phosphorous, and low solids, and is therefore appropriate for treatment with domestic effluents at the Bunlicky facility. As part of this licence review there is a proposal to incorporate waste G.HCL into the process wastewater stream. This liquid waste is produced over a small number of days each month during specific production. It is characterised by high nitrogen levels and suspended solids and is currently drained into IBCs for removal offsite as waste. Whilst the resulting maximum Total N and Suspended Solids levels in the worst case wastewater stream (i.e. in the unlikely scenario that the G.HCL discharge is made on a day when there is limited additional wastewater in the equalisation tanks to provide dilution) would therefore be greater than those currently in place for the installation, the infrequent discharge and the available dilution within the onsite Wastewater Management Area tanks would be sufficient to ensure no significant impact on the downstream wastewater treatment plant. This is discussed further in Section 7 of this application.

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The installation currently managed this effluent as a waste which is sent offsite for incineration. It is not possible to treat this effluent onsite due to the small volumes produced and the low BOD of the effluent. As the Bunlicky WWTP has capacity to treat this effluent it is considered that the preferential option is to discharge it to the sewer and reduce the volume of waste for disposal (incineration).

16.0 CONCLUSIONS

This non-technical summary includes a brief overview of the IE licence application, detailing each of the sections contained within the application that are relevant and applicable to the Regeneron site

It should be noted that in order to obtain comprehensive detailed description of the installation and the activities that will be carried out there, the full application should be viewed.

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Attachment 1.2 Non-Technical Summary 1.0 INTRODUCTION · accompanied by an Environmental Impact Assessment Report (EIAR) prepared in compliance with the EU Directive on EIA. Planning

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