Attachment 1.2 Non Technical Summary · The MSD Ireland (Biotech Dublin) facility, a biologics drug substance facility, is currently being developed on an existing MSD-owned property,

Attachment 1.2 Non-Technical Summary

Application ID LA001652

MSD International GmbH trading as MSD Ireland (Biotech Dublin)

Project reference: PR-284956

Project number: 60569850

27 June 2019

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Attachment 1.2 Non-Technical SummaryProject reference: PR-284956

Project number: 60569850Application ID LA001652

Prepared for: MSD International GmbH trading as MSD Ireland (Biotech Dublin) AECOM

Quality information

Prepared by Checked by Verified by Approved by

Patricia HowardSenior EnvironmentalConsultant

Peter HassettTechnical Director

Caroline DonnellyAssociate Director

Peter HassettTechnical Director

Revision History

Revision Revision date Details Authorized Name Position

1 22 February 2019 Initial Draft Yes Peter Hassett Project Director

2 25 February 2019 Final Yes Peter Hassett Project Director

3 27 June 2019 Revised Final Yes Peter Hassett Project Director

Distribution List

# Hard Copies PDF Required Association / Company Name

0 1 MSD International GmbH, trading as MSD Ireland (Biotech Dublin)

0 1 Environmental Protection Agency

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Prepared for:MSD International GmbH trading as MSD Ireland (Biotech Dublin)

Prepared by:Patricia HowardSenior Environmental ConsultantM: + 353 87 2331426E: [email protected]

AECOM Ireland Limited

4th Floor

Adelphi Plaza

Georges Street Upper

Dun Laoghaire

Co. Dublin A96 T927

Ireland

T: +353 1 238 3100

aecom.com

© AECOM recognises that Merck & Co retains the copyright of this report content, but not theintellectual rights, under the terms of Section 8 to an Engineering, Procurement and ConstructionManagement Master Agreement between Merck & Co and AECOM Technical Services Inc., dated 30th

March 2016.

Where any conclusions and recommendations contained in this Report are based upon informationprovided by others, it has been assumed that all relevant information has been provided by thoseparties and that such information is accurate. Any such information obtained by AECOM has not beenindependently verified by AECOM, unless otherwise stated in the Report. AECOM accepts no liabilityfor any inaccurate conclusions, assumptions or actions taken resulting from any inaccurateinformation supplied to AECOM from others.

The methodology adopted and the sources of information used by AECOM in providing its servicesare outlined in this Report. The work described in this Report was undertaken between September2018 and November 2018 and is based on the conditions encountered and the information availableduring the said period of time. The scope of this Report and the services are accordingly factuallylimited by these circumstances. AECOM disclaim any undertaking or obligation to advise any personof any change in any matter affecting the Report, which may come or be brought to AECOM’sattention after the date of the Report.

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Table of Contents

1. Introduction.............................................................................................................................. 1

2. Facility Description................................................................................................................... 1

2.1 Overview ....................................................................................................................... 1

2.2 Site History .................................................................................................................... 3

2.3 Facility Operations ......................................................................................................... 5

2.4 Environmental Management .......................................................................................... 8

3. Materials Use ........................................................................................................................ 10

3.1 Material Use & Storage ................................................................................................ 10

3.2 Resources, Fuels and Energy ...................................................................................... 10

4. Emission Sources & Environmental Considerations ............................................................... 12

4.1 Emissions to Air ........................................................................................................... 12

4.2 Wastewater .................................................................................................................. 13

4.3 Storm Water................................................................................................................. 13

4.4 Noise Emissions .......................................................................................................... 15

4.5 Soil and Groundwater .................................................................................................. 15

5. Emissions Control and Abatement ......................................................................................... 16

5.1 Emissions to Atmosphere ............................................................................................. 16

5.2 Wastewater Emissions ................................................................................................. 16

5.3 Storm Water Emissions ................................................................................................ 17

5.4 Noise Emissions .......................................................................................................... 18

5.5 Potential for Emissions under Abnormal Circumstances ............................................... 18

6. Waste Management ............................................................................................................... 19

7. Application of Best Available Techniques (BAT) ...................................................................... 19

8. Abnormal Operating Conditions ............................................................................................. 20

9. Cessation of Activities ............................................................................................................ 21

10. Cross Boundary Impacts ........................................................................................................ 21

11. Alternatives............................................................................................................................ 21

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Project number: 60569850Application ID: LA001652


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1. Introduction

AECOM Ireland Limited (AECOM) has been engaged by MSD International GmbH t/a MSD Ireland(Biotech Dublin) (hereafter referred to as MSD Ireland (Biotech Dublin)) to fulfil the role of leadconsultant for the preparation of their Industrial Emissions (IE) Licence Application.

This non-technical summary provides, in non-technical language, a summary of the informationprovided in the IE Licence Review Application. The summary has been provided under the followingheadings in order to reflect the requirements of the EPA Guidance1.

· Facility Description

· Materials

· Emission Sources

· Environmental Conditions

· Reduction/Abatement Technologies/Techniques

· Waste Management

· Preventative Measures in accordance with BAT

· Measures Abnormal Operating Conditions

· Facility Closure

· Monitoring and Sampling of Emissions

· Assessment of Alternatives

2. Facility Description

2.1 OverviewThe MSD Ireland (Biotech Dublin) facility, a biologics drug substance facility, is currently beingdeveloped on an existing MSD-owned property, the site of its former MSD Organon facility in Swords,Co. Dublin.

MSD’s vision is to make a difference in the lives of people globally through innovative medicines,vaccines, biological therapies and animal health products. It aspires to be the best healthcarecompany in the world and is dedicated to providing leading innovations and solutions for tomorrow.

Its mission is to discover, develop and provide innovative products and services that save andimprove lives around the world. MSD products cover a range of areas including heart and lung health,care for women’s health, cancer treatment, infectious diseases and many more disease areas. Everyyear, it invests millions of euro in research to bring new medicines to the world.

In the past five decades MSD has invested over €2.2bn in Ireland and contributes significantlytowards making the pharmaceutical industry the country's leading export sector.

Today MSD employs 2,300 people directly in Ireland and provides an additional 9,000 indirect jobsthrough its operations at its sites across Ireland.

1 Licence Application Form Guidance Industrial Emissions (IE), Integrated Pollution Control (IPC) and Waste, Version 2 March2018

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The MSD Ireland (Biotech Dublin) facility will play a pivotal role in the manufacture of MSD’s biologics-based medicines, including in the area of immuno-oncology, and will expand MSD’s current internalnetwork of biologics drug substance manufacturing plants.

The new facility will fall under class 5.16 of listed activities in the Frist Schedule of the EPA Act 1992(as amended) defined as requiring an IE Licence:

‘5.16 The production of pharmaceutical products including intermediates (production means theproduction on an industrial scale by chemical or biological processing’

During submission for planning permission in 2018 it was determined that the development wassubject to an Environmental Impact Assessment Report (EIAR) by the Planning Authority (FingalCounty Council), a copy of both the Planning Permission and EIAR are included with this applicationwithin Attachment 6.2.

The MSD Ireland (Biotech Dublin) facility will undertake the manufacture of biopharmaceuticalmedicines that do not involve the use of significant quantities of dangerous substances. It is proposedthat the facility will operate 24 hours per day, 7 days per week, 52 weeks per year. Based onmaximum anticipated material inventories, it has been established that the Seveso III Regulations arenot applicable to the MSD site under proposed operating conditions. There are no Seveso III siteswithin proximity to the site.

The site is located approximately 1km south east of Swords town centre and 3km north east of DublinAirport. The site is located in a mixed industrial, commercial and residential area and in accordancewith Fingal Development Plan 2017-2023 the majority of the site is zoned for industrial use (GeneralEmployment and High Technology).

A site location map for the MSD Ireland (Biotech Dublin) facility is presented in Drawing ReferencePR-284956_IEL_ACM_DR_ENV_001_1_B (Site_Loc_Map) of this IEL Application and a site layoutplan is presented in Drawing Reference PR-284956_IEL_ACM_DR_ENV_002_2_A (Site_Plan).

Immediate surrounding land use and infrastructure includes:

· To the north, the site’s access road fronts onto the Drynam Road which runs along the northernmargin of the site and is connected to the main Malahide Road to the north and the Feltrim Roadto the south.

· On the other side of Drynam Road there are residential housing developments (Milesian Lawn,Milesian Court, Milesian Avenue, Milesian Grove) and a church.

· Immediately east of the site and along most of the east boundary, there are industrial units(Feltrim Industrial Park and Feltrim Business Park) immediately beyond which the M1 motorwayextends in a north-south direction.

· Immediately south of the site is the more recently (2012) developed access road via the HolywellLink Road beyond which there are residential estates (“Holywell”).

· To the west are open fields beyond which are the Airside Retail Park and Pavilion ShoppingCentre.

The site elevation ranges from approximately 25m above Ordnance datum (mAOD) and 29 mAODand slopes down from the north to the south towards a culverted stream (Gaybrook Stream) locatednear the site south east boundary. The culverted Gaybrook Stream traverses west to east across thesouthern part of the site.

The MSD Ireland (Biotech Dublin) biological drug substance campus, when constructed, will cover anarea of 44,000m2 (gross floor area) operating on the 134,000 m2 site of the former (MSD InternationalGmbH owned) Organon Ireland Limited site in Swords, Co. Dublin.

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2.2 Site HistoryThe site was developed for Organon (Ireland) Ltd. in 1989 from what was originally farm land andproduction commenced in 1990. Between 1990 and 2015 there were a number of additions andmodifications to the facility until production activities ceased in 2016 and all operations were ceasedas of June 30, 2017.

The original Organon (Ireland) site consisted of production facilities, together with a warehouse,laboratories, offices, car parking and technical service facilities in addition to a number of ancillarybuildings such as site security, two boiler houses, electrical switch rooms, water softening plant, storerooms, compressor room, transformer room, solvent stores rooms, sprinkler tank, pump house and apumping station. In addition to open areas used for car parking, access and landscaping.

Table 1 serves to summarise the site’s development history. Historical production activities on siterelated to the formulation and packaging of a range of human health products (contraceptives, fertilitytreatments and hormone replacement therapy (HRT) treatments) and products in therapeutic areassuch as anaesthesiology and mental health. Products included tablets, parenterals (sterile preparationwhich are injected through the skin or mucous membrane) and creams. These production activitiesdid not fall under any class of activity listed in the Frist Schedule of the EPA Act 1992 (as amended).

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Table 1 Summary of Historical Development Onsite

Date Development

1988 IDA improved site drainage, culverted the Gaybrook stream and soldsite to Organon.

May 1989 Ground clearance

1990 Facility opened

1992/1993 Construction of new warehouse on western side of the site

1994 Extensions to the laboratory and car park, offices constructed on thefirst floor behind the laboratory and the main entrance of the building

1994 Construction of pharmaceutical production clean rooms.

1995/1996 Extensions to the car park, offices and canteen at the northern side ofthe site, extension of the packaging area at the western side of the site.Construction of a workshop at the southern end of the facility buildingand construction of new solvent store near the western boundary.

1996 Construction of an implants facility

1998 Extensions to tableting, laboratories and construction of the east roadalong the western side of the site, expansion of the car park at thenorthern side of the site.

2001 Extension to packaging facility

2001/2002 Completion of a new site services development. Construction ofmaterials handling facility (MHF) for packaging, handling and storage ofproducts. Construction of a car park to the west side of the MHFbuilding. New MV switch room, electricity substation and generatorcompound, new boiler house and stack, new gas cylinder storage areas,new pumping station including three sumps (two process, one foul).

2003 Warehouse and office expansion. Installation of underground effluentstorage tanks, replacing older tanks.

2006 Expansion of solvent store

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Table 1 Summary of Historical Development Onsite

2012 Construction of the south entrance to the site

2015 Construction of a security building adjacent to southern entrance

2016/2017 Production activities ceased in 2016 and all operations were ceased as of June 30, 2017

Apart from the various planning permissions required to accommodate the developments as outlined in Table 1, the original Organon (Ireland) Facility did not require an EPA licence as it used less than 10 tonnes per year of solvents and the formulation and packaging activity itself was not a licensable activity. The Organon (Ireland) facility was also exempt from the then Solvent Regulations 2002 (S.I. 543 of 2002) as the site used less than 50 tonnes per annum of organic solvents. Fingal County Council had issued the Organon (Ireland) facility with the following environmental licences:

A licence to operate an industrial plant (Reference number APL/4/94) in accordance with the Air 1.Pollution Act 1987. This licence has since been revoked; and

A trade effluent discharge licence from FCC (WPS/F/067), for discharging wastewater (process 2.and foul) to sewer. This licence was since revoked.

For the construction and commissioning (up to the point of Industrial Emissions licensing of the MSD Ireland (Biotech Ireland) campus) including the decommissioning of the former Organon (Ireland) production suite, on 03rd July 2018 Irish Water issued a licence to discharge effluent to sewer, licence reference IW-DTS-825553-02. In addition, Fingal County Council issued a licence for the discharge of treated water (arising from deep excavations) to waters (the Gaybrook Stream), permit reference WPW/F/079 on 12th December 2018.

2.3 Facility OperationsThe new MSD Ireland (Biotech Dublin) involves the conversion of some of the buildings related to the former Organon (Ireland) manufacturing facility to a Biopharmaceutical Manufacturing Campus which requires the alteration and extension of existing buildings, the construction of new buildings, the installation of ancillary external utilities, demolition works, and all associated site development works and landscaping.

In summary the proposed conversion will comprise:

The internal alteration of the existing Warehouse Building to accommodate the installation of a 1.new Biopharmaceutical Manufacturing Process.

The internal alteration of the existing Manufacturing Building to accommodate the installation of 2.utility systems to support the new Biopharmaceutical Manufacturing Process. This will include 3No. new Boilers and an associated flue stack. Room for a fourth boiler has been allowed for, including a flue within the flue stack and allowance has been made in the IE licence application to accommodate the fourth emission point.

The construction of a new 2-storey Laboratory Building3.

The construction of a new single storey (with internal mezzanine) Warehouse Building.4.

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The extension of the existing Spine Corridor southwards to link the new Laboratory Building and 5.Warehouse to the existing buildings, and the provision of a new staff entrance and reception at this location.

Conversion of part of the former Organon (Ireland) production space into a Manufacturing, 6.Science and Technology (MS&T) Laboratory

The partial demolition of existing utilities plant and buildings and the creation of a new central 7.utilities area including:

a. Central Utilities Building (CUB) comprising:

i. Boiler Room incorporating 3 No. clean steam boilers (and room for a fourth boiler);

ii. Compressor room incorporating 2 No. air compressors;

iii. Chiller room incorporating 4 No. chillers; and

iv. A workshop.

b. An external Utilities Yard containing:

i. Salt storage (for water softening);

ii. Non-potable water storage and a water treatment room;

iii. 2 No. emergency diesel powered generators (with room for a third unit) and associated transformers and a 30,000 litre capacity double skinned and bunded diesel storage tank;

iv. Medium Voltage and Low Voltage electrical switch rooms;

v. 2 No. (one high voltage and the other medium voltage) electrical switch room buildings;

vi. Water pump and treatment building;

vii. Bunded gas and diesel storage tanks.

Water for Injection (WFI) and clean steam generation within the production building;8.

A Communications Room; 9.

11 No. Dry coolers located on the roof of the former laboratory building on the northern side of 10.the site (with room allowed for two more dry coolers);

An on-site wastewater management facility;11.

A 750 m3 storm water attenuation tank;12.

A sub-surface 200 m3 spill/contaminated firewater retention tank servicing hazardous materials 13.storage;

Miscellaneous small Buildings (security huts, firewater pump house, drum store) retained and a 14.new pump house;

Office and canteen space; and15.

Waste storage areas (hazardous and non-hazardous waste storage areas).16.

Site works include the diversion of the existing culverted stream within the site, and amending it to a partially-open stream, modification to the internal road network and car parking, 2 No. new bicycle shelters, and enhanced boundary and site landscaping.

The total gross floor area of the facility, post development, is ca. 44,000m2 .

A number of elements of the existing site buildings and facilities will be retained (largely unaltered) aspart of the new campus. These include;

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· The existing Administration, Canteen and Laboratory wing;

· Firewater storage tank, pump house and drum store located at the north-west corner of theexisting Warehouse (new Manufacturing);

· The main car parks located adjacent to the Drynam Road entrance (to be reduced by 100spaces), and to the west of the existing Warehouse (new Manufacturing);

· Existing site Security Buildings at the northern (Drynam Road) entrance and southern (HolywellLink Road) entrance;

· Site boundary fencing; and

· Primary site perimeter roads.

The new MSD Ireland (Biotech Dublin) facility will be a multiproduct facility producing mammalian cellculture based protein therapeutics including monoclonal antibodies. The facility is intended to be amulti-product with both campaign and concurrent manufacturing capabilities.

The MSD Ireland (Biotech Dublin) facility has been designed to handle Biosafety Level 1 geneticallymodified organisms (GMOs) which are considered low risk in respect of human and environmentalimpact. MSD Ireland (Biotech Dublin) has separately applied for a GMO consent to the EPA.

The manufacturing process to be employed by MSD Ireland (Biotech Dublin) in the proposedManufacturing Building (conversion of the existing Warehouse) will follow what are now considered asindustry standard techniques for the production of "medicines for patients" using biotechnologyderived processes. Today, this approach is favoured over traditional organic chemistry routes used inthe past because it is capable of yielding more complex molecules for medicinal applications, is moreefficient in terms of productivity, poses lower safety risks, and has less environmental impact in termsof hazardous chemicals used or waste generated for disposal.

The primary process steps per production train are as follows:

─ Upstream: Cell Culture and Harvest; and

─ Downstream: Purification and Product Formulation.

The process is represented in a Block Flow Diagram in Figure 1.

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Figure 1: Proposed MSD Ireland (Biotech Dublin) Biologics Manufacturing Process

All of these primary process steps will be located within cleanrooms to be constructed within thefootprint of the Manufacturing Building. These operations will be supported by the following processareas:

─ Media Preparation (internal) - Buffer Preparation (internal) - Column Packing (internal)

─ Component Preparation (internal)

─ Wastewater Management (internal and external)

─ Process Utility Supplies (internal and external)

A detailed description of the production unit operations to be undertaken at the MSD Ireland (BiotechDublin) facility are provided in section 2.2 of attachment 4.8.1 (Operational Report) of this IEapplication.

Extensive quality control laboratories will be installed on site to provide testing for all stages ofproduction. The Quality Control Laboratory accommodates quality control test procedures related tothe production process within the Manufacturing Building.

The MS&T Laboratory will be built to support production and data analytics activities. Effectively, theMS&T laboratory will contain all of the essential production and laboratory capability of the maincampus only on a much smaller scale

2.4 Environmental ManagementMSD Ireland (Biotech Dublin) will put in place an Environmental Management System (EMS) inaccordance with the required Conditions of the site’s IE Licence and MSD standards. The site will alsoput in place an environmental policy and Environmental Management Programme and will becommitted to adopting the best available technology and processes to attain a high standard ofenvironmental control throughout the site operations.

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MSD Ireland (Biotech Dublin) are in the process of developing a dedicated EHS team who, on thebasis of qualifications and technical ability, will have an appropriate level of technical competence tomanage environmental issues at the MSD Ireland (Biotech Dublin) site.

A documented management system will be put in place on commission for the control, monitoring andevaluation of site activities which may have an environmental impact.

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3. Materials Use

3.1 Material Use & StorageRaw materials, laboratory chemicals and cleaning agents will be used at the facility. A new Warehouse Building will be constructed on the site to accommodate product and other materials storage and management for the proposed production process being developed within the Manufacturing Building.

Storage areas on site are indicated in Drawing Reference PR-284956_IEL_ACM_DR_ENV_008_1_A (Waste_Material_Storage) of this IEL Application.

Further details on raw materials are provided in Attachment 4-6-2 of this IE Licence application.

The MSD Ireland (Biotech Dublin) campus has been designed to minimise external storage of materials (raw materials, utility chemicals, diesel fuel and other potentially polluting substances) generally. This includes the implementation of a ‘just-in-time’ warehouse design and philosophy.

The areas of the site which will store materials which are classified as hazardous to the environment and conditions of storage are listed as follows:

· Hazardous Materials (Hazmat) Storage Area within the new warehouse. Materials will be stored largely in receptacles of varying volume and in liquid or solid state (in bags from 1 kg to 1,000 kg or in liquid storage units from mL volume through to 1,000 litre IBC’s). The Hazmat area will be protected against spillage by a sub-surface 200m3 retention tank (sized also to accept sprinkler water in the event of a fire).

· - 2 to 8ºC Storage Area in the new warehouse;

· Ambient Storage Area of the new warehouse;

· Small material storage areas in the MS&T Laboratory;

· Central Utilities Building (CUB). Materials here will include dosing chemicals in small bunded tanks ;

· Utility Yard: Diesel fuel will be stored in a 30,000 litre double-skinned and bunded tank. A salt saturator salt supply will also be stored in a bunded tank. The oil-filled transformers for the emergency generators will also be bunded;

· Manufacturing Building: Cleaning in Place (CIP), buffer and media solutions will be stored in tanks to feed distribution loops to manufacturing process unit operations. Storage will be protected from spillage by contained process drainage with leak detection;

· Wastewater Management Facility: Here sodium hydroxide and sulphuric acid will be stored in 2,000 L bunded tanks. This area will be protected against spillage by a 25m3 underground retention tank; and

· Quality Control (QC) Labs where various chemicals typically found in QC laboratories will be stored as required in small receptacles and in designated flammable storage cabinets or other cabinets segregated based on hazard properties.

3.2 Resources, Fuels and EnergyThe MSD Ireland (Biotech Dublin) campus will utilise:

Mains water;1.

Mains natural gas supply (via a new gas supply skid being constructed on site); and2.

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Main grid electricity supply. 3.

Diesel oil will be stored on site for the use in emergency generators and fire-pumps only (which will be tested on a regular basis).

The boilers in the Central Utilities Building will run only on natural gas and will provide the site steam requirements.

Details on quantities of resources, fuels and energy use is provide in Attachment 4.6.1 to the IE application.

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4. Emission Sources & Environmental Considerations

4.1 Emissions to AirDrawing PR-284956_IEL_ACM_DR_ENV_004_1_A (Main_Air_Emission_Points) details thelocation of the site’s main emission points to atmosphere and drawing PR-284956_IEL_ACM_DR_ENV_009_1_A (Minor_Air_Emissions_Points) details the location of thesite’s minor emission points to atmosphere.

4.1.1 Main Air Emission

Three new Boilers and associated flue stacks will be added to a newly refurbished boiler house.Additional space and infrastructure (e.g., a fourth flue) has been provided for a fourth boiler andhence a fourth main emission point has been included in the IE application. Combustion emissionsfrom the boilers are the only main emissions included in the proposed development. Natural gas onlywill be used to fuel the boilers and is sulphur free. There are no plans to deploy an auxiliary fuel suchas diesel.

Emissions from the boiler flues will be combustion gases comprising carbon monoxide (CO), nitrousoxides (NOx), carbon dioxide (CO2), excess oxygen and water vapour.

The nitrous oxides emissions from the boilers will comply with the limits stated in the EU (MediumCombustion Plants (MCP)) Regulations 2017 (S.I. No. 595 of 2017) for new combustion plant, notincluding engines and turbines, of 100mg/Nm3.

Emissions to atmosphere from the proposed site boilers have been subject to dispersion modellingwhich has concluded that nitrous oxide emissions from the MSD Ireland (Biotech Dublin) campus willhave a negligible impact on ambient air quality, human health and the environment.

4.1.2 Other Air Emissions (Minor, Fugitive & Potential)

A number of minor emission points will be located on the site from for example, bioreactor vents,storage vessel vents, emergency generators, fire pump vents, heating ventilation and air conditioning(HVAC) systems and laboratory fume hoods.

Activities at MSD Ireland (Biotech Dublin) will be aqueous based and so with a limited potential togenerate fugitive emissions of volatile organic compounds (VOCs) or other chemical substances.Fugitive emissions at MSD Ireland (Biotech Dublin) will comprise mainly Isopropyl alcohol (IPA)emissions from the use of IPA containing cloths and sprays for equipment and area cleaning. Tracefugitive VOC emissions may also be generated during chromatography column packing, dispensingactivities in the buffer preparation area and from the removal of filters from sterilant solutions.

Potential emission points will primarily comprise of pressure relief devices for a range of productionequipment, utility equipment and supply systems. It is noted that the MSD Ireland (Biotech Dublin)facility will operate largely at atmospheric pressure and at ambient to moderate temperatures. Assuch, there are no operations on site that would be considered potentially unstable (e.g., runawayreactions).

MSD Ireland (Biotech Dublin) has also applied to the EPA for a Green House Gas (GHG) permit underDirective 2003/87/EC amended by Directive 2009/29/EC (collectively called the Emissions TradingSystem Directive) on account of the total installed thermal input capacity of the three boilers,emergency generators and fire-pumps.

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4.2 WastewaterThe biotechnology processes to be used at the MSD Ireland (Biotech Dublin) facility will generate arange of process aqueous waste streams containing primarily biodegradable organic components,nutrients, detergents and salts. The utility equipment that will be provided at the facility to support theproduction process will also generate aqueous waste streams containing low levels of biodegradableorganics. Sanitary wastewater (sewage) will also arise from the proposed 350 employees plusvisitors.

The main volume of wastewater arising from the facility will be generated in the manufacturingbuilding. The basic sources of the various aqueous wastewater streams from the facility will be asfollows:

· Production Areas:

§ Inactivated pre-culture, cell culture and harvest process wastewater (process effluent);

§ Process effluent from recovery, purification and formulation; and

§ Clean in Place (CIP) process effluent.

· Centralised Utilities:

§ Reverse Osmosis (RO) reject

§ Water softener brine;

§ Boiler / cooling tower blowdown

· Domestic / sanitary wastewater (normal sewage form toilets, lockers, showers and the canteen).

As part of the facility design, detailed descriptions, characterisation, mass balances (includingaverage and peak parameter data) and process flow diagrams for process wastewater streams wasundertaken. The biotechnology processes for the MSD Ireland (Biotech Dublin) facility do not involvechemical reactions and thus are relatively straightforward in the context of wastewatercharacterisation compared with other pharmaceutical manufacturing operations.

4.3 Storm WaterAn extensive storm water drainage network currently serves the entire site and conveys storm water(rain water) run-off by gravity from all areas of the site in a southerly direction connecting, at a numberof locations, into the Gaybrook Stream which traverses the site in a west to east direction via a newlyinstalled culvert (replacing an older culvert). Ultimately, the Gaybrook Stream conveys storm waterfrom the site and surrounding catchment to the Broadmeadow / Malahide Estuary.

It is intended that the existing storm water drainage network serving the site will be preserved as faras possible except where local diversions are required to accommodate the new Laboratory andWarehouse buildings.

The proposed storm water drainage philosophy is represented in Figure 2 and incorporatesmaximising on the existing storm drainage network, upgraded and added to in order to accommodatethe new MSD Ireland (Biotech Dublin) campus.

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Westside of Manufacturing BdgDrynam Road gullies

West Car park

New QC Lab,Warehouse and

Internal roads to South

Roof beneathDry Coolers

Existing Admin canteen,Eastside of Manufacturing Bdg

Central Utilities Building

Bulk of Utilities Yard Area

Diesel Storage andGenerator Compound

ExistingHydrocarbonInterceptors

NewHydrocarbonInterceptors

New 750m3

AttenuationTank

ExistingHydrocarbonInterceptors

New 7,600 l Class 1HydrocarbonInterceptor

valve

valve

valvevalve

CulvertRealignment

SW2

SW3

SW1

SW1-M

SW2-M

SW3-M

NewCulvertContinuesUnder M1

TOC

GaybrookStream

Existing Infrastructure New Infrastructure

WWMF Underground Tank

Figure 2: MSD Ireland (Biotech Dublin) Storm Water Philosophy.

A portion of the realigned culvert closest to the site entrance to the south is now an open channel. Inaddition, the construction of the new Lab and Warehouse (including realigned access road andwarehouse yard) will add approximately 21,000m2 (or 35%) to the overall impervious area of the site.Accordingly, the upgrade and extension of the site storm water drainage system has been designed infull accordance with the principles of Sustainable Urban Drainage Systems (SUDs). Arising from aSUDs assessment, a new 750m3 volume underground storm water attenuation tank will be installed inthe south-eastern portion of the site. All storm water from the Lab and Warehouse area (includingrealigned access road and warehouse yard) will gravitate to the tank, be attenuated by means of acontrol outlet valve, and discharge as a single emission point to the Gaybrook Stream. All storm waterrunoff will pass through hydrocarbon interceptors prior to discharge from the site.

All storm water arising on site will enter into the culverted Gaybrook Stream via three storm waterdischarge points (SW1, SW2, SW3) and storm water monitoring will take place nearby each emissionpoint at SW-1M, SW2-M and SW-3M respectively.

All three storm water emission points to the Gaybrook Stream will be protected by auto-shut valvesthat will be actuated from the fire alarm system in a fire scenario. Manual over-ride of the alarmsystem will be provided in the unlikely event of a spill of potentially polluting substance that runs therisk of entering the storm drainage system.

In addition, all three storm water emission points will be protected by five oil-water interceptorslocated at strategic points across the site. In the case of emission point SW3, that will include twointerceptors in series, including a Class 1, 7,600 litre capacity new interceptor serving the utility yarddiesel storage off-loading area and emergency generator transformers.

An assessment to consider contaminated fire water was also undertaken for the MSD Ireland (BiotechDublin) site. The assessment concluded that contaminated fire water storage was not required.Notwithstanding that conclusion, a 200m3 dedicated tank was installed sized to deal with a potentialfire in the Warehouse.

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4.4 Noise EmissionsThe primary sources of noise emissions from the MSD Ireland (Biotech Dublin) facility will be thoseassociated with external operations such as air handling units, coolers, vents, boiler operation andoperations from the WMF.

An operational impact assessment has been undertaken to predict the noise levels from the proposedMSD Ireland (Biotech Dublin). This can be found in Attachment 7.1.3.2 of this IEL Application.

The predicted noise levels at the nearest noise sensitive receptors are below the limit values of55 dB LAeq during daytime hours, 50 dB LAeq during evening and 45 dB LAeq during night-time hours.The predicted sound pressure levels of the modelled sources meet the lower 45 dB LAeq limit andsubsequently the daytime and evening limits.

The predicted noise levels have also been added to the measured noise levels as recorded duringnoise monitoring to predict the cumulative noise levels at each receptor. The largest predictedincrease in the cumulative sound level is 3 dB which is not considered to be a significant increase.

During planning each of the major potential noise sources associated with the proposed MSD Ireland(Biotech Dublin) facility was identified with the site designers and representative sound power datawas assigned to reflect the acoustic design goals.

Drawing PR-284956_IEL_ACM_DR_ENV_007_2_A (Monitoring Point Locations) details the noisemonitoring locations.

4.5 Soil and GroundwaterA site Baseline Screening Report (Attachment 4-8-2) was prepared and it was concluded from thescreening exercise that a full Baseline Report is not required for the site.

Detail on the site history in respect of soil and groundwater impact and management is presented ina Site Condition Report (Attachment 4-8-3). Key conclusions from the Site Condition Report are asfollows:

· On the basis of the physical setting of the site and its operational history, there is considered tobe a Low risk of soil and/or groundwater beneath the site having been impacted by hazardoussubstances.

· At the former Organon facility, hazardous substances on site were limited to activepharmaceutical ingredients (APIs), small quantities of organic solvents, hypochlorite, caustic anddetergent based cleaning reagents and diesel. Intrusive site investigation of the former Organonfacility, conducted in 2010, identified no potential contaminants present in soil or groundwaterabove relevant screening criteria. Additional soil sampling was conducted as part of the siteredevelopment works and no potential contaminants have been detected in soil above screeningcriteria, neither have APIs or related compounds been detected.

· The site is underlain by a thick layer of low permeability, clay-rich, glacial till, which affordsprotection to the underlying bedrock aquifer. Limited shallow perched groundwater has beenencountered within this till, and it is not considered to provide a complete lateral pathway forcontaminant migration.

· Proposed operations at the campus will have limited quantities of relevant hazardous substancesstored and used on site. In addition, safeguards are being included in the site construction toprovide secondary and tertiary containment where significant volumes are to be stored andtransferred. Therefore, proposed site operations are also considered to be a low risk of soiland/or groundwater beneath the site being impacted by hazardous substances in the future.

Compliance with requirements of the EC Environmental Objectives (Groundwater) Regulations 2010,S.I. No, 9 of 2010, is assessed on both the Chemical and Quantitative status of the groundwater body.

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The bedrock groundwater body beneath the site is currently classified as being of Good status andnot at risk.

The site is not, and has no plans to, abstract from or recharge groundwater to the aquifer; therefore, it will have no likely impact on the Quantitative status of groundwater.

The Chemical status of groundwater is assessed by comparing the results of groundwater samples tothe published groundwater threshold values (GTVs), as issued in 2010 and amended in 2016. Froman assessment of available groundwater results, no exceedance of GTVs is reported.

No emissions to soil or groundwater will arise from the site.

5. Emissions Control and Abatement

5.1 Emissions to AtmosphereAs outlined in section 4.1 there will be three main emission points from three new boilers. Combustionemissions from the boilers are the only main emissions from the new MSD Ireland (Biotech Dublin)facility. The boilers will be routinely inspected and will be placed on the site preventative maintenanceschedule. As part of this IE application it has been proposed that the boilers will undergo annualmonitoring.

No specific abatement is in place for air emissions nor is abatement required.

5.2 Wastewater EmissionsAll process effluent, except sanitary wastewater, will be conveyed via pipework to a new on-siteWastewater Management Facility (WMF). The WMF will also have the capacity to store/processeffluent that does not meet the correct specification prior to pumping to the Irish Water sewer in acalamity tank.

Process effluent from upstream processes within the manufacturing building will contain BiosafetyLevel 1 cell based material. This process effluent will be drained to a ‘biowaste inactivation’ systemwhere the effluent will be flow and load balanced prior to heat treatment (indirectly heated with steam)for a certain period of time to inactivate cell material. The inactivated process effluent will then bepumped to join process effluent from other parts of the site before being pumped to the WMF.

The combined process effluent from the MSD Ireland (Biotech Dublin) campus will be largelycharacterised by easily biodegradable organic matter, nutrients nitrogen and phosphorus, inorganicsalts, detergents and suspended solids.

Pumped process effluent from the WMF will ultimately discharge to the greater Swords drainagenetwork which in turn connects to the Swords conglomerate Irish Water Wastewater Treatment plantat Spittal Hill Road where the effluent will receive secondary and tertiary treatment including nutrientremoval.

Sanitary wastewater will be pumped separately to a different point on the Swords foul drainagenetwork and will also be ultimately conveyed to the Irish Water Wastewater Treatment plant at SpittalHill Road. Domestic wastewater from the canteen will flow through a grease-trap system on site priorto pumping to the Swords foul drainage network

The proposed on-site WMF will provide pre-treatment to the process effluent only and will consist ofthe following component treatment steps:

· Solids screening;

· Wastewater Balancing;

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· Cooling;

· pH neutralisation; and

· Monitoring

A detailed overview of the system is provided in attachment 4.8.1 Operational Report of the IEapplication.

Raw untreated effluent entering the site WMF will be monitored continuously for flow rate, TotalOrganic Carbon (TOC), temperature and pH as a minimum.

An outfall monitoring point (SE1-M) will be provided at the WMF final outfall sump. Flow rate, pH, TOCand temperature at exit to the reception sewer will be continuously monitored and recorded. The pHand TOC monitoring shall also align with a control facility to activate the auto-recycle to return flow onpH and/or TOC control in the event of out of specification readings.

A 24-hour proportional flow composite sampler, with refrigeration, will also be provided for finaleffluent sampling and subsequent off-site laboratory analysis for other IE Licence parameters.

Suitable access for manual sampling of raw effluent shall also be provided.

A 25m3 underground retention tank will be located adjacent to the WMF to protect against possiblespillages from WMF chemicals use. This tank has been sized taking into consideration chemicalsupply truck volumes. In addition to this, during a chemical filling process the storm water valve will beplaced in the closed position to prevent potentially contaminated storm water entering the storm waterdrainage system.

5.3 Storm Water EmissionsThere will be a number of both fixed and temporary/mobile bunds at the MSD Ireland (Biotech Dublin)facility, which are in place to contain accidental spills or leaks of potentially harmful chemicals,ensuring that there is no release to the off-site surface water network. The Diesel tank in the UtilityYard will also be double skinned and surrounded by a bund. There will be three oil-cooledtransformers located next to the emergency generators which will also be bunded.

The site will include emergency shut off valves near each of the three site storm water drainagesystems to allow automatic shut-off of the storm water sewers, upstream of the points of connection tothe culverted tributary of the Gaybrook Stream traversing the site. These valves will be linked to thebuilding fire alarm system and to the Building Management System (BMS), and will be closed in theevent of an emergency such as a fire or an accidental spillage. This will provide a high level ofprotection to the stream.

All storm water will pass through an oil-water interceptor, i.e., two existing units for the site west(SW1) and east (SW3) storm drainage networks, two new units associated with SW2 in the south-east of the site and a new Class 1 interceptor (SW3) for the Utility Yard which will include servingdiesel storage and emergency generator transformers.

A TOC meter will also be deployed to protect the storm water drainage system serving the roof areaon which a series of dry-coolers are located and which will contain an ethylene glycol coolant. Shoulda leak of coolant be detected by the TOC meter, an isolation valve will be shut and will providestorage for up to 45 m3 of water potentially contaminated with ethylene glycol directly beneath the dry-coolers.

A separate designated firewater run-off facility with a capacity of 200m3 will also be provided for thebunded area in the warehouse where hazardous materials will be stored to specifically protect againstfirewater run-off from this area being released from the building and potentially entering the tributaryof the Gaybrook Stream.

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5.4 Noise EmissionsExternal equipment will be, where possible, located in areas that will minimise noise emissions at noise sensitive receptors. Where possible equipment will be screened using acoustic cladding or barriers and equipment sound power levels are a consideration during design and procurement.

5.5 Potential for Emissions under Abnormal CircumstancesProcess unit operation malfunctions will be limited in terms of equipment involved since each process step is a separate process ‘package’ with its own control panel and emission relief systems.

The potential for process malfunctions and associated potential impact to the environment will be minimised through:

Hazard and Operability (HAZOP) at multiple stages for all site systems during design resulting in 1.fail-safe system design, containment, detection and alarming;

The adoption of design (and improvement of same) from the KEYTRUDA process deployed in 2.New Jersey, U.S and Oss, The Netherlands;

Deployment of a preventative maintenance system;3.

Operation of batch based processing in a highly regulated and controlled environment and with 4.specialised process operations training;

Implementation of IE licensing and an Environmental Management System; and5.

Constant data analytics through systems such as Delta V and BMS and including automated 6.control.

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6. Waste Management

Wastes that will be generated from the MSD Ireland (Biotech Ireland) facility will be largely non-hazardous in nature. This will include solid waste (such as filters and personal protective equipment)that will have been autoclaved on site to remove the risk of GMO contamination. Small quantities ofhazardous waste will include laboratory chemicals, waste chemicals from other campus facilities(such as utilities) and small quantities of waste with the potential to be contaminated with GMOs andwhich will require off-site specialist treatment. Other wastes generated will include:

· Canteen food (biodegradable) waste;

· Construction & demolition waste;

· Office / administrative waste; and

· Waste electrical and electronic equipment (WEEE).

MSD Ireland (Biotech Dublin) will put in place a comprehensive waste management programmeincluding for the prevention (where possible) and management of waste generated at the MSD Ireland(Biotech Dublin) site. The waste management operations at MSD Ireland (Biotech Dublin) will followthe priorities of the waste hierarchy and avoid significant volumes of waste being sent unnecessarilyto landfill.

For waste whose generation on site cannot be prevented, measures will be put in place to ensure thatwaste is collected separately (where technically, environmentally and economically practicable) andwill not be mixed with other waste or other material with different properties.

The MSD Ireland (Biotech Dublin) waste management programme will specifically outline that allwastes generated onsite will have regard to the waste management hierarchy and where feasibleshall be managed in the following order of preference:

a) Strategic Sourcing/Sustainable Use of Materials

b) Prevention

c) Reduction

d) Re-use

e) Recycle

f) Energy Recovery

g) Treatment

h) Disposal

Full details on typical waste likely to be generated by MSD Ireland (Biotech Dublin), including detailson estimated quantities, are provided in Attachment 8-2.

7. Application of Best Available Techniques (BAT)

In Attachment 4 of the IE licence application, MSD Ireland (Biotech Dublin) has detailed anassessment of compliance with the following BAT Conclusions (BATC), Best Available Techniques(BAT) Guidance Notes and BAT Reference (BREF) documents:

· BAT Conclusions (BATC): Commission Implementing Decision (EU) 2016/902 of 30 May 2016Establishing Best Available Techniques (BAT) Conclusions, under Directive 2010/75/EU of theEuropean Parliament and of the Council, for Common Wastewater and Waste GasTreatment/Management Systems in the Chemical Sector (Attachment 4.7.1);

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· In combination the BREF document for the Manufacture of Organic Fine Chemicals, August 2006(Attachment 4.7.2) and BAT Guidance Note on Best Available Techniques for Pharmaceuticaland other Speciality Organic Chemicals, EPA 2008 (Attachment 4.7.2);

· BREF Document on Best Available Techniques for Energy Efficiency, February 2009 (Attachment4.7.2);

· BREF Document on Best Available Techniques on Emissions from Storage, July 2006(Attachment 4.7.2); and

· BREF Document on Industrial Cooling Systems (ICS), December 2001

Of note in respect of BAT is that the MSD Ireland (Biotech Ireland) facility is, for the most part, a newfacility and has been designed to incorporate BAT and EPA guidance requirements in respect ofbuildings, equipment and technical systems (e.g., control systems). Other, more ‘soft’ BAT standardssuch as an environmental management system will be developed during the commissioning phaseover the year 2020 and during full scale operation (scheduled for Q1, 2021).

8. Abnormal Operating Conditions

An Emergency Response Plan (ERP) will be put in place which will detail the initial response to anenvironmental, health or safety related incident on site, for example a fire, chemical spillage or gasleak. The plan will detail the Emergency Response Team onsite. The ERP will also describe theprocedures for handling emergencies on the MSD Ireland (Biotech Dublin) site and for ensuringenvironmental risks are contained and minimise any adverse impacts on the environment.

Plant, processes and materials will be examined, through a process of risk assessment, and areasthat may give rise to safety or environmental emergencies have been identified. Risk Assessmentswill be conducted for the site and the ERP updated accordingly.

The site is manned by a 24/7 security team.

A preventative maintenance management system will also be put in place across the site.Furthermore the calibration of key control equipment will be managed by a dedicated softwareprogramme which will prompt MSD Ireland (Biotech Dublin) personnel of when key equipmentrequires periodic calibration by specialist third parties.

Environmental, health and safety considerations have been incorporated into the design process withthe aim of managing abnormal operating conditions through specific EHS design reviews, ATEXreviews, HAZOPS or other Process Hazard Analysis (PHA) tools and Job Safety Analysis (JSAs).

In the event of a loss of power to the site the two emergency generators will maintain essential siteservices. A loss of mains power to the site or a malfunction of the wastewater inlet screening systemwould result in a closure of the WMF pumping mechanism until the site generators becomeoperational. Adequate storage capacity via both the incoming trade effluent equalisation tank andcalamity tank is provided to collect any effluent (process and foul) generated for 24 hours after thepower failure.

In the event of a failure of the pH neutralisation system at the WMF, out-of-specification trade effluentwill be diverted back to the calamity tank which is interconnected with the equalisation tank.

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9. Cessation of Activities

A Closure Plan will be submitted, if required by the Agency, following commencement of the operation.Where required this document will be prepared in accordance with the Environmental ProtectionAgency’s Guidance on Assessing and Costing Environmental Liabilities (2014).

Any site closure would be undertaken as a timely and well planned cessation event, rather than asudden cessation with immediate effect as per the EPA guidance document.

10. Cross Boundary Impacts

There are no anticipated impacts over long distances or outside the territory of Ireland as a result ofthe proposed operations at the MSD Ireland (Biotech Dublin) facility.

All emissions will be, in the future, monitored as per the site IE Licence.

11. Alternatives

Consideration of alternatives has been considered as part of the Environmental Impact AssessmentReport submitted as part of the sites planning permission (also provided in attachment 6-3--6of this IEapplication) and also summarised in section 9 of the Operational Report (attachment 4.8.1).

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Documents

Attachment 1.2 Non Technical Summary · The MSD Ireland (Biotech Dublin) facility, a biologics drug substance facility, is currently being developed on an existing MSD-owned property,