This memo was approved to go to the Board by Marie O'Connor, Senior Inspector

Date: 25.09.14

OFFICE OF CLIMATE, I LICENSING & RESOURCE USE

To: Directors

From:

Date: 25th September 2014

Bernie Murray and Dr Tom McLoughlin PROGRAMME

ENVIRONMENTAL LICENSING

Application for an Industrial Emissions Licence from Regeneron Ireland, Ballycummin, Raheen Business Park, Raheen, Co. Limerick.

Licence Register PO99 1-01-0 1 RE:

Class of activity:

Category of Activity under IED ( 20 10/7 51 E U) :

Licence application received:

Additional information requested:

Additional information received:

EIS received

Supplementary material submitted by applicant

Submissions received:

Site notice inspected:

Site visits: I

5.16: Production of pharmaceutical products including intermediates

4.5: Production of pharmaceutical products including intermediates

16th April 2014

23rd July 2014; 2lSt August 2014

31St July 2014; 26th August 2014

16th April 2014 18th July 2014; 15th August 2014

One (Health Service Executive)

8th May 2014

loth July 2014

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1. Company Regeneron Ireland proposes to operate a biopharmaceutical manufacturing installation at the former Dell EMF3 installation, Ballycummin, Raheen Business Park, Raheen, Co. Limerick.

The company has identified a need for additional manufacturing capacity to support the company’s ability to supply growing demand for its medicines in Europe and other parts of the world. To fulfil this need the company is proposing to develop a new state-of-the-art manufacturing centre in Ireland.

The installation will be based on Regeneron‘s existing large scale biopharmaceutical manufacturing installation in Rensselaer, New York and entails the installation of new biopharmaceutical manufacturing processes to the existing production area (previously used by Dell-EMF3 computer assembly installation). This will involve the retrofitting of the existing production area to include cleanrooms, warehousing, clean water and steam utilities, including boilers, heating ventilation and air conditioning systems and electrical switch rooms. This installation is intended to ultimately accommodate four production trains within the Production Building to meet current and future manufacturing needs. The installation is being scheduled in two phases, each comprising two trains and associated support functions.

The project can be broadly described under the following headings:

9

9

9

b

Installation of a new biopharma plant in the existing Dell-EMF3 production area, Le, cleanrooms, warehousing, clean water and steam utilities including boilers, heating, ventilation and air conditioning system (HVAC). This will require the following modifications to the existing production area: an extension of the floor area by 3,909m2 to accommodate internal warehousing and electrical rooms; increase in the height of the roof over the existing production area to accommodate the HVAC system; the installation of 5 new boiler flues (stacks); and the modification of the existing production area to include new access points. A Quality Control Building (4,000 m2 over 3 floors) will be constructed on the site to accommodate quality control test procedures related to the proposed manufacturing process being developed within the Production Area. The proposed location for the laboratory is on the western side of the existing headblock within the existing site car park area. Installation of new external utilities in the existing yard area to include: emergency generators, bunded cooling towers, water chillers, process and fire water storage tanks, pump house, bunded chemical and diesel storage tanks, gas storage area, 38kV electrical substation, natural gas pressure reducing station. Other site works include: modification and additions to existing underground site services covering: sewer, water and fire mains, electrical communications and gas ducting, security hut and new landscaping works.

The installation will be engaged in the manufacturing of “medicines for patients” using modern biotechnology / biologics technology. Phase 1 of the proposed activity is scheduled to commence in Quarter 1 of 2015. The proposed development will be fully complete and operational in 2016.

According to the company, this approach is now favoured over the traditional organic chemistry routes used in the past. It has many advantages including the ability to produce more complex molecules in GM cell lines for medicinal applications. It is more efficient in terms of productivity, poses lower safety risks to the surrounding community, and has less environmental impact in

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terms of hazardous chemicals used or waste generated for disposal. By 2016, 9 out of 10 most popular medicines (revenue generated) will be produced using biologics'.

2. Process Description The installation will use GM cell lines, in particular Chinese Hamster Ovary (CHO) cells that are genetically modified to produce different proteins for medicinal uses. They are classified as Class 1 GMMs (activities of no or negligible risk) under EU GMO legislation. The applicant was issued with a consent for the contained use of Class 1 GMMs (G0549-01) on 7/8/2014. The company has a number of potential drug products in late stage clinical trials. Depending upon the outcome of those clinical trials and subject to regulatory approval, it plans to produce drugs for the treatment of cholesterol, rheumatoid arthritis, atopic dermatitis, asthma, colorectal cancer and sight loss. This technology has been used in the biopharma industry for over three decades with a history of safe use.

The manufacturing process starts by thawing vials (usually 1-2 ml) containing the GMM, whose content is inoculated into a series of shaker flasks and wave bags to seed bioreactors of increasing size. This step-wise scale up of cells (from the shake flask to the wave bag to the seed bioreactors (SOL, 500L, 3000L)) will then be used to inoculate large scale production bioreactors (10,000 litres). To ensure sterility the small scale GM culture inoculations are carried out in a bio-safety cabinet using aseptic techniques.

The seed bioreactors are operated on a four day batch cycle with approximately two days for growth and two days for equipment turnaround (cleaning, maintenance, setup for the next batch). The cells are held in the bioreactors, provided with oxygen and growth media for cell culture growth, pH controlled and then transferred to the next bioreactor after a set number of days. Ultimately, the cells are maintained in the production bioreactors for a longer period so that they can produce the desired protein. The growth media solutions are prepared by mixing pre-purchased mixture of solids with water on a batch basis in a separate area. These solutions are transferred to the bioreactors on a predetermined schedule to support the growth of the cells at different volume stages.

Under normal operating conditions, there is no liquid waste from the bioreactors. Any in- process leaks or spills will be diverted to the floor drains, where liquid waste for heat treatment in the heat inactivation system is collected. The cell culture fluid contains cells, cell fragments and proteins, along with the desired product. During the cell culture and recovery stages of the process, the fluid is centrifuged to remove suspended solids and is then passed through retentive filters to remove residual cell debris. The desired proteins pass through the filters and are sent to the Capture and Purification suites for subsequent recovery and purification.

All atmospheric vents from the process equipment will be equipped with sterile vent filters ca'pable of retaining particles smaller than 0.2 micron in size.

The purification process involves chromatography (pH adjustments), ultrafiltration/diafiltration (UF/DF), viral filtration and purification steps. The final steps are bulk filling and freezing prior to shipping off-site for formulation into the final product. Liquid waste from the purification steps (devoid of any live cells) will be collected in the process waste drain system and will be directed to the wastewater management area for pH adjustment before discharge to the municipal WWTP.

Barry Heavey, IDA, GMO conference 20 I3 I

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Biowaste (liquid process waste that could contain live cells) will be collected from the cell culture and harvest areas and diverted to the heat inactivation system. The biowaste will be subjected to high temperature (212lOC) for a set period of time (1120 seconds) to ensure that any cells in the filtrate are inactivated before transfer to the wastewater management area.

All contaminated solid waste including cells (GMM) and cell fragments retained by the filters will be processed through the decontamination autoclave (temperature / time parameters to be established during autoclave validation). GMM waste from the QC laboratory (only small volumes) will be inactivated chemically or by autoclaving.

I n order to maximize productivity, all of the major processing equipment is cleaned via an automated Clean I n Place (CIP) system. The equipment is rinsed with high purity water (water for injection-WFI) and residual soil is removed by use of recirculating cleaning solutions (caustic wash solution and phosphoric acid rinse solution). Initial rinses from CIP will be diverted to the biowaste collection and the heat inactivation system. All aqueous wastewater will be recovered from the cleaning systems and directed to the wastewater management area.

I n conclusion, the primary process steps in the Regeneron manufacturing process can be summarised as follows:

> Cell Culture > Harvest > Purification > Product Formulation

3.

BAT for the installation was assessed against the BAT Conclusions contained in the following documents: . BAT Guidance note for Pharmaceutical and other speciality organic chemicals, 2008 . BREF ”Integrated Pollution Prevention Control (IPPC) Reference document on Best

Available Techniques for the manufacture of Organic Fine Chemicals” (2006) (Also referred to as the OFC BREF)

Note that aspects of the following reference documents also have relevance: Reference Document on Best Available Techniques in Common Waste Water and Waste Gas Treatment / Management Systems in the Chemical Sector, February 2003; . Reference Document on Best Available Techniques for Energy Efficiency (February 2009); . Reference Document on Best Available Techniques for Emissions from Storage (July 2006); . BREF Document on the General Principles of Monitoring, July 2003.

Decision on Best Available Techniques (BAT) Conclusions / BAT Guidance Note

The applicant submitted an assessment of the installation activity against the relevant BAT Conclusion requirements contained in the above BREF Documents. The applicant has stated that the installation will subscribe fully to the principles of BAT in both the design and operation of the installation.

We consider that the applicable BAT Conclusion requirements are addressed through: (i) the technologies and techniques as described in the application; (ii) the standard conditions specified in the RD.

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4. Emissions 4.1 Main Emissions to Air The main pollutant emissions relate to natural gas-fired boilers and arise from 5 x 7.9 MW natural gas-fired steam boilers. When the installation is fully operational (i.e. 4 production lines plus associated services) four boilers will be in operation with the fifth on standby. The boilers will be designed for low NOx emission (80mg/Nm3 dry basis, 3% 0,). The low NOx emission design will be achieved through fuel-air ratio control.

Table 2 provides a summary of the Boiler Emission Points to atmosphere from the proposed installation.

Table 2: Boiler Emission Points Ref Source of Emissions Emissions A l - 1 A1-2 A1-3

Steam Boiler No. 1, 7.5MW, natural qas fired Steam Boiler No. 2, 7.5MW, natural gas fired Steam Boiler No. 3, 7.5MW, natural qas fired

NOx, CO NOx, CO NOx, CO

A1-4 A1-5

Steam Boiler No. 4, 7.5MW, natural qas fired Steam Boiler No. 5, 7.5MW, natural qas fired

NOx, CO NOx, CO

Minor Emissions to Air There are 2 x 1.8 MW low temperature, natural gas fired hot water boilers which will be operated on a duty/assist basis when the installation is fully operational.

I n addition there are 130 minor emission points (A3-1 to A3-130). These relate to: extract vents from biosafety cabinets / cell culture process equipment which are fitted with HEPA filters or 0.2pm sterile vent filters respectively; VOC emissions primarily relate to ethanol storage / ethanol dilution for the preparation of chromatography columns. Ethanol vapour emissions from the 25,OOOL ethanol storage tank will be minimised through the use of a nitrogen blanket and conservation vent. I n addition, Chromatography gel lab fumehoods which will be fitted with a HEPA filter; Water vapour from a clean steam generators and cooling towers (seven cooling towers will be provided for the new installation); Particulate emissions from material sampling /dispensing are expected to be minor owing to the employment of HEPA / dust filters.

Fuqitive Emissions Minor fugitive emissions could occur during the filling of ethanol and diesel bulk material storage tanks as well as from QC lab fumehoods where relatively small quantities of solvent will be used. Other potential sources of fugitive emissions arising from the process include isopropyl alcohol and glacial acetic acid. While condition 6.7 requires the licensee to prepare a programme for the reduction of fugitive emissions, the plant will be designed to minimise the number of potential sources of fugitive emissions by using low-leak equipment (valves, pumps etc).

Potential Emissions Five 2,500kVA emergency generators fuelled by diesel will provide .back-up power supply in the event of loss of electrical power. They will only be used for emergency cover and will be run for approx. 30 minutes per week for maintenance purposes.

I n the event of a fire on site, 2 diesel supplied fire water pumps will be activated. Their emissions include NOx, CO PMlo/2.s and SO2

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There will be no anticipated odorous emissions from the installation.

Impact of the Air Emissions on the Receivinq Environment The applicant completed air dispersion modelling to assess the potential impact of atmospheric emissions using air dispersion modelling software AERMOD Version 7.7

Background concentrations for Zone C (which includes Limerick) were taken from the EPA document ‘Air Quality in Ireland 2012, Key Indicators of Ambient Air Qualiv.

I n Table 3 the process contribution for NOx and CO have been added to the background concentrations to give the Predicted Environmental Concentrations.

Table 3: Air Dispersion Modelling Results Description

l h r NO2

Parameter Background Process Predicted concentration’ contribution Environmental

Concentration

18 140.9 158.9 Nitrogen Oxides (C19/m3>

Carbon monoxide (mg/m3)

19 I 9.2 I 18-2 Annual NO2 1 :r3 123.2

Annual NOx 1 ;;o 8hr CO 658.3

I I I

:h, Quality 1 Standards’ (PEC as O/O of

200 (79.5%)

40 (46%) I 30 (77.3%)

10,000 (6.6%)

I

‘Air Quality Standards Regulations 2011 (S.I. No 180 of 2011)

taken from EPA document ‘Air Quality in Ireland 2012, Key Indicators of Ambient Air Quality’ Background air quality concentrations for Nitrogen Dioxide, Nitrogen Oxides and Carbon Monoxide

The modelling approach is conservative as: (i)

(ii) (iii)

it was carried out based on a worst case peak load scenario i.e. 4 x 7.5 MW thermal input boilers and 1 x 1.8 MW thermal input boiler all operating at the same time; the emissions from the 5 boilers were modelled for 24 hours/day, 365 days/year; the background air quality concentrations that were used were the most conservative figures available.

Discussion of modellinq results Modelling of boiler emissions was carried out a t 100mg/Nm3 of NOx and the Predicted Environmental Concentrations (PEC) were within the short term and annual air quality standards. The RD proposes a limit of 100mg/Nm3 for NOx (as NO2) which is in accordance with BAT.

Modelling of CO was carried out at 60mg/Nm3. The PEC is within the air quality standards (25% of the AQS). The RD proposes a limit of 60mg/Nm3 for CO.

Considering the conservative assumptions adopted in modelling and the requirements in the RD, it is unlikely that air emissions from the installation will have a significant impact on the local environment. The limits applied in the RD are as proposed by the applicant and are in accordance with the BAT Guidance Note for the Pharmaceutical & Other Speciality Organic Chemicals Sector.

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4.2 Wastewater generated from the proposed development will arise from a number of sources namely: (0 process / manufacturing; (ii) laboratories; (iii) utilities / sanitary.

Emissions to Shannon Development pipeline

The process effluent from the installation (which could contain live cells) will receive preliminary on-site treatment, i.e. it will be heat treated, pH balanced, cooled (to a maximum of 40°C), prior to discharging through SE-1. It was clarified during the assessment process that the discharge through SE-1 will not be a direct discharge to sewer, rather it will discharge to the Shannon Development foul sewer within Raheen Business Park which ultimately connects to Irish Water’s public foul sewer serving Limerick City and Environs. Shannon Development has consented to Regeneron Ireland utilising the existing connections to storm and foul water sewer collection systems in Raheen Business Park. Cooling will occur naturally during effluent transfer although air cooled heat exchangers are also envisaged.

Foul effluent from showers, lockers, toilets and canteen will be collected separately and discharged without treatment or monitoring via the Shannon Development foul sewer to the same WWTP, a t a different location i.e. SE-3. The total Population Equivalent loading from these foul sources is estimated to be in the order of 100 p.e. This organic load is small (<1%) compared with the estimated p.e. due to process sources described below and in overall terms is deemed to be included in the process load.

While Irish Water has agreed to the discharge, the responsibility for the discharge lies with Shannon Development, the owners of the public foul sewer with Raheen Business Park into which Regeneron Ireland will discharge. Therefore, it is in the remit of Shannon Development to regularise issues in relation to their discharge to sewer for which a licence may be required.

That said conditions, emission limits, and monitoring requirements as deemed to be appropriate have been incorporated into the RD. The RD provides for a maximum emission limit value of 1,800kg BOD/day (30,000 p.e./day) to cater for occasional daily peak loadings (after 2016 when the four production trains will be operational), subject to not exceeding a maximum loading of 8,400kg BOD/week (20,000 p.e./day. The RD also requires: that a grease trap be installed a t the outlet from the canteen prior to entering the Shannon Development pipeline (SE-3); that the pipework discharging to SE-1 and SE-3 shall remain separate with no cross connections; and, that the discharge to SE-3 shall be sampled annually and analysed in accordance with Schedule 6.3.

Limerick City and Environs WWTP was commissioned in 2003. It has preliminary, primary and secondary treatment, and has a design capacity of 130,000 p.e. The applicant in consultation with Irish Water has confirmed that Limerick WWTP in Bunlicky has 30,000 p.e. spare capacity to receive and adequately treat wastewater from the proposed installation. The WWTP holds a wastewater discharge licence from the Agency Reg. No D0013-01. Monitoring returns (2013) indicate that the treatment plant handled loadings extremely well and had no incidences of ELV breaches.

The company will implement the BAT measures in accordance with the Reference Document on Best Available Techniques for the Manufacture of Organic Fine Chemicals, Common Waste Water and Waste Gas Treatment / Management Systems in the Chemical Sector as well as for Energy Efficiency. The effluent treatment proposed is equivalent to that required by BAT.

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4.3 Emissions to Water There are no proposed discharges of effluent to surface water from the.installation

4.4 Storm Water Storm water run-off from buildings, car-parks, roadways, service yards and other developed areas of the site will discharge via a petrol interceptor (SE-2) to the Shannon Development storm water sewer serving the Raheen Business Park which ultimately drains via the Barnakyle stream to the Shannon Estuary. The risk of contamination of storm water run-off from the installation is IOW, given the nature of operations, and the mitigation measures proposed, as set out in section 9 below. I n order to prevent the contamination of storm water the RD requires that:

tank, container and drum storage areas be bunded; 0 silt traps and oil separators be installed; 0 underground pipes, tanks, bunding structures and containers be tested for integrity and

water tightness every three years; and, 0 storm water emissions be monitored.

4.4 Emissions to around There are no proposed discharges to ground or groundwater a t the installation and therefore there is no predicted impact to the groundwater environment due to the proposed installation. The current status of the groundwater in the River Maigue catchment, where the proposed development is located, is classified as ‘Poor’. Five groundwater monitoring wells (MW-1 - MW- 5) were installed as part of site investigations and groundwater samples were taken for a range of parameters. Four of the wells were found not to be contaminated while the remaining fifth well was found to have elevated levels of potassium, sulphate and ammonia which the applicant attributed to nearby agricultural activity or septic tank discharge.

The ’baseline report’ submitted with the application is discussed in Section 9 below.

There will be an underground drainage network on site for process wastewaters and foul sewerage. The integrity and water tightness of all underground pipes will be tested in accordance with condition 6.8 of the RD. Groundwater will be monitored in accordance with Schedule C.6.1

All raw materials will be stored indoors.

5. Waste The operation of the installation will result in the generation of a range of hazardous and non- hazardous wastes which will be segregated at source.

Approximately 500 tonne/annum of general non-hazardous waste (comprising packaging waste, office waste, kitchen waste, empty containers, filters) will be produced and 60% of this material will be recycled.

Hazardous wastes generated at the installation will include laboratory waste chemicals, fluorescent tubes, batteries, waste oils, empty hazardous material containers etc. Laboratory waste chemicals will be segregated where possible and stored in a designated chemical store in suitable containers prior to collection by a licensed waste contractor for recovery or disposal. Hazardous wastes from the production of drugs will include raw material packaging, spent filters, reject product and reject packaged product.

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Potentially contaminated solid waste will be inactivated in-house by autoclaving, prior to collection for disposal. This is a condition of Regeneron Ireland’s GMO consent (G0549-01).

Fluorescent tubes, batteries, waste oils and empty containers will be sent for recovery and recycling. Approximately 100 tonne of hazardous waste is produced per annum. All hazardous waste will be collected by a permitted hazardous waste contractor,and brought to a licensed installation for disposal, recovery or recycling.

The RD requires that all waste sent off site is transported and recovered/disposed of in accordance with National and European Legislation, and that waste records are maintained.

6. Noise There will be a small number of different noise sources associated with the operation of the installation. The main noise sources identified include cooling towers and associated pumps, chillers and condensers.

Based on the existing noise levels and noise impact assessment it is predicted based on modelling that the additional noise contribution from the installation will not cause a significant negative impact at noise sensitive locations, the nearest of which is approximately 400m away. The RD specifies noise limits of 55dB LAr,T (daytime), 50dB LAr,T (evening-time) and 45dB LAeq,T (night-time), a t the boundary of the installation. There shall also be no clearly audible tonal component or impulsive component in the noise emission from the activity at any noise sensitive location. Condition 6.12 requires an annual noise survey to be carried out.

7. Use of Resources I n relation to energy and water usage on site the total energy used and volumes of water extracted per year etc. will be determined once the installation is operational. These figures will be provided in the first Annual Environmental Report as part of the proposed I E licence. The company will implement the BAT measures in accordance with the BREF Document on Best Available Techniques for Energy Efficiency.

Several process related raw materials/chemicals will be used on site. The applicant requested that certain of the information contained in the application relating to these raw materials / chemicals be held as confidential to which the Agency has partly agreed.

There will be H400 (R SO), H410 (R50-53), H411 and H412 substances used and stored on site. The amount of these substances to be stored on-site will not be confirmed until the installation is operational. Some 8000L of H411 will be stored on-site.

The total rated thermal input from the installations on the site will exceed 20 MW. An application for an emissions trading permit is currently being prepared by Regeneron Ireland in accordance with EPA Guidance.

8. Measures to be taken to prevent accidents and limit consequences Regeneron Ireland’s proposed installation is not a seveso site. An Accident Prevention and Emergency Response Procedure is not in place for the installation since it is currently being retrofitted. The prevention of accidental emissions and spills will be facilitated by the correct design of equipment and operations at the site in the following areas:

> Bunding and Collection; > Storage and Transport; > Training; 0 Procedural Control;

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> Emergency Response; > Site Drainage; > Containment of Firewater.

Condition 9.1 of the RD requires procedures to be put in place in advance of the date of commencement of the activity to prevent accidents with a possible impact on the environment and to respond to emergencies so as to minimise the impact on the environment.

9. A 'baseline report' following the stage approach recommended in the EC Draft Guidance' was submitted with the application during which it was established that the site was previously used for computer assembly and is currently a brownfield site.

Measures to be taken upon cessation

On completion of guidance stages 1 - 3 (screening for Baseline Report requirement), the likelihood of potential soil and/or groundwater contamination was deemed to be low given the site history, the quantities of hazardous substances due to be used, produced or released at the installation and the proposed control and containment measures to be put in place, notably:

0 All material handling will be undertaken either indoors or in external areas of hard standing designed to eliminate a direct pathway for any hazardous substances to pollute the underlying ground;

0 Potential contaminants have been identified and storage measures have been assigned to ensure containment;

0 All tanks, containers and drum storage areas will be rendered compatible with the material they store;

0 All bulk storage tanks and containers will be contained within bunded areas to 11Oo/o of their capacity;

0 A bund inspection programme will be undertaken; 0 Any spills will be localised, contained within the hard standing, bunded production area; 0 A procedure will be put in place to check the capacity in the tanks before filling.

On this basis, the applicant concluded that further progression through guidance stages 4 - 8 was not necessary and consequently the production of a full baseline report was not required.

Groundwater and soil monitoring were covered under Section I of the application. Elevated levels of potassium, sulphate and ammonia were revealed at one groundwater monitoring well. This well was situated side-gradient of the manufacturing areas. The elevated levels were not associated with any previous site land use, rather they were attributed to possible nearby agricultural activity or septic tank discharge. The other four groundwater monitoring wells were found not to be contaminated. Soil analysis was also undertaken (at separate locations to the monitoring wells) and the investigations did not reveal any evidence of soil contamination.

I n conclusion, the site is currently uncontaminated and poses no environmental risk and the risk of contamination from the proposed activities is deemed to be low owing to the nature of the operation and the proposed control and containment measures described above. Based on this information, clean conditions will be assumed in the event of cessation of the activity and consequently the Agency has not required the submission of a full baseline report.

European Commission Guidancc conccrning basclinc rcports undcr Articlc 22(2) of Directivc 2010/75/13U in industrial 2

emissions.

Page 10 of 21

Schedule C of the RD requires soil monitoring to be carried out every 10 years, and groundwater monitoring to be carried out every 2 years, in accordance with the requirements of the IED.

10. The Fit & Proper Person test requires three elements of examination:

Fit & Proper Person Assessment

- Technical Ability

- Legal Standing

- Financial Standing

The applicant has not been convicted of any offences under the EPA Acts.

An Environmental Liabilities Risk Assessment (ELRA) was prepared by the applicant in accordance with the new EPA Guidance on Assessing and Costing Environmental Liabilities (2014). The financial provision was based on the combined risks that pose the plausible worst case scenario. This corresponded to the maximum liability that may be incurred and was calculated as €764,605 and subsequently rounded up to €1,000,000.

It is considered on the basis of the information provided that the applicant meets the required technical and financial requirements and can be deemed a Fit & Proper Person for the purpose of this licence.

Condition 12 of the RD requires the licensee to arrange for an independent and appropriately qualified consultant to review the ELRA, as submitted with the licence application, and to submit a reviewed report on the Environmental Liabilities Risk Assessment in advance of commencement of the activity. It also requires the applicant to make financial provision to cover any liabilities associated with the operation of the installation in advance of the commencement of the activity.

Condition 10 of the RD requires the preparation of a Decommissioning Management Plan (DMP) prior to the commencement of the activity. The RD also requires the applicant to provide details of the costings for the plan as well as the financial provisions to underwrite those costs. The plan will be reviewed annually as part of the Annual Environmental Report (AER).

11. Compliance with EU Directives

Environmental Liabilitv Directive (2004/35/CE)

The Environmental Liabilities Directive has been transposed into national legislation by European Communities (Environmental Liability) Regulations 2008 (S.I. 547 of 2008). An Environmental Liabilities Risk Assessment (ELRA) has been provided by the applicant and a detailed Closure Plan will be developed and submitted to the EPA prior to the commencement of the activity, in accordance with the recent EPA Guidance on assessing and costing environmental liabilities.

The RD includes conditions and schedules, which require the licensee to control operation of the activity and meet the specified ELVs. The RD includes, under Condition 9, measures to be taken in the case of an incident. Condition 10 requires a DMP to be prepared in advance of commencement of the activity while Condition 12 requires an ELRA to be reviewed and approved by the Agency within prior to commencement of the activity. Condition 12 of the RD as drafted, satisfies all the requirements of the Environmental Liabilities Directive in particular those requirements outlined in Article 3(1) and Annex I11 of 2004/35/EC.

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Seveso Directive (96/82/EC) as amended by 2003/105/EC The manufacturing activities proposed for this site do not involve the use of significant quantities of dangerous substances. Based on maximum anticipated material inventories, it has been established by the applicant that the proposed installation is not a Seveso site under the governing legislation.

Air Qualitv Directives (2008/50/EC] As outlined above dispersion modelling of emissions to air was undertaken for the application, which indicated that emissions from the installation will not cause any breaches of relevant Air Quality Standards as specified in S.I. No 180 of 2011.

Water Framework Directive [2000/60/EC1, European Communities Environmental Obiectives (Surface Water) Requlations, S.I. No 272 of 2009, European Communities Environmental Obiectives (Ground Water) Requlations S.I. No 9 of 2010 There are no proposed process emissions to surface water or to groundwater from the installation. Storm water from the installation (SE-2) discharges to a surface drain and ultimately discharges to the Shannon Estuary. The RD includes conditions relating to the surface water run-off and bunding requirements. Storm water run-off will be directed via silt traps and a Class 1 bypass petrol interceptor.

Habitats Directive (92/43/EC) & Birds Directive (79/409/EEC)

The installation discharges treated process effluent and sewage effluent to Shannon Development pipeline where it is then conveyed, via the sewer, for further treatment at the municipal WWTP in Bunlicky municipal WWTP (D0013-01) before discharging into the River Shannon Estuary. The proposed installation is not located within any conservation site. The proposed development lies approximately 3km from the Lower River Shannon cSAC (002165) which is so designated for a range of habitats listed under Annex I Habitats, including, sandbanks, estuaries mudflats, coastal lagoons and alluvial forests with Alnus glutinosa and Fraxinus excelsior (alder and willow) as well as examples of other important habitats. The coastal lagoons and alluvial forests are priority habitats. The proposed installation also lies approximately 3.5 km from the River Shannon and River Fergus Estuaries SPA (4077) which have listed Annex 1 species and Non-Annex 1 migratory populations.

A screening for Appropriate Assessment was undertaken to assess, in view of best scientific knowledge and the conservation objectives of the site, if the proposed activity, individually or in combination with other plans or projects, is likely to have a significant effect on a European Site(s). I n this context, particular attention was paid to the European site(s) a t Lower River Shannon cSAC (002165), Glenomra Wood cSAC (001013), Tory Hill cSAC (00439), Glenstal Wood cSAC (001432), River Shannon and River Fergus Estuaries SPA (004077) and Slievefelim to Silvermines Mountains SPA (004165). The Agency considered, for the reasons set out below, that the proposed activity is not directly connected with or necessary to the management of the site as a European site and that it can be excluded, on the basis of objective information, that the proposed activity, individually or in combination with other plans or projects will have a significant effect on a European site, and accordingly the Agency determined that an Appropriate Assessment of the proposed activity was not required.

This determination was made in light of the scale and nature of emissions to the environment as described in the application and the capacity of Bunlicky municipal WWTP (D0013-01) to receive and treat effluent discharges from the installation.

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Environmental Impact Assessment Directive(85/337/EEC)

The applicant submitted an Environmental Impact Statement (EIS) which was prepared in support of planning application Ref. 13/745. Planning permission was granted for this development by Limerick County Council on 31St March 2014.

0 Content of EIS

We have considered and examined the content of the EIS and other material (information submitted in the licence documentation, correspondence between the Agency and the planning authority carried out under Section 87 of the EPA Acts and submissions made by third parties in relation to the EIS). We consider that having examined the relevant documents and with the addition of this Inspector's Report that the likely significant direct and indirect effects of the activity have been identified, described and assessed in an appropriate manner as required in Article 3 and in accordance with Articles 4 to 11 of the EIA Directive as respects the matters that come within the functions of the Agency. We consider that the EIS also complies with the EPA (Industrial Emissions) (Licensing) Regulations 2013.

Notice under Section 87(1E)(a) issued

Response to Section 87( 1E)ca) Notice received :

0 Environmental ImDact Assessment (EIA)

An EIA, as respects the matters that come within the functions of the Agency, has been carried out in accordance with Section 83(2A) of the EPA Acts,! as detailed below.

24/04/2014 to Limerick County Council

01/05/2014

An assessment as regards the functions of the planning authorities was carried out by the planning authority when granting planning permission for the development (Planning File Ref. 13/745). That assessment addressed the likely significant effects of the construction and operational phases of the development. The planning authority's assessment was considered as part of the Agency's assessment. The planning authority's assessment was considered as part of the Agency's assessment.

Notice under 87(1F) received:

Consultation was carried out between Limerick County Council and the Agency in accordance with Section 87( lF), and 87( 1E) of the EPA Acts, as follows:

21/1/2014 from Limerick County Council

Response to 87( 1F) Notice made: 29/1/2014 ,

The Planning Authority did not provide any additional observations to the Agency on the licence application and EIS.

The assessment outlined in this report considers the submissions and observations exchanged between Limerick County Council and the Agency. All third party submissions/observations received which are relevant to impacts on the environment have also been considered and taken into account.

The submitted EIS and the assessment as described in this Inspectors Report address the likely significant direct and indirect effects arising from the activity, as respects the matters that come within the functions of the Agency.

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Likefv siqnificant effects

The following section identifies, describes and assesses the main likely significant direct and indirect effects of the activity on the environment, as respects the matters that come within the functions of the Agency, for each of the following factors: human beings, flora, fauna, soil, water, air, climate, the landscape, material assets and cultural heritage. The main mitigation measures proposed to address the range of predicted significant impacts arising from the activity have also been outlined.

by applicant in EIS or I E licence application Note 1

1. Human Beings

Disturbance to (potential) roosting bats and breeding birds

Likely significant effect

Ten bat boxes and ten bird nest boxes will be erected and cleaned out annually between November and

Economic activity

Likely significant Description of effect effect

Contamination from Accidental emissions from accidental emissions or spillages which leaks could impact on Accidental emissions soil/groundwater through underground drains quality. and pipes.

material spillages or fuel

Health & Safety

Mitigation measures proposed by applicant in EIS or I E licence application Note 1

Measures as per Table No. 6, ‘Water’, below.

The integrity and water tightness of all underground pipes will be tested.

Note 1: and/or as outlined

2. Flora & fauna Likely

significant effect

Impacts on Fauna

Description of effect

Impact of traffic on: road network;

0 existing traffic.

Impacts from the handling of raw materials and active pharmaceutical ingredients

bove in this report

Mitigation measures proposed by applicant in EIS or I E licence

application Note 1

Staff mobility management measures would be operated staff car-pooling website bike to work scheme public transport ticket scheme

Not classified as a Seveso site. Operational activities will comply with Irish and EU legislation governing Health & Safety in the workplace. A safety statement will be produced. Condition 9 of the RD requires that Accident Prevention and Emergency Response Procedures be put in place, reviewed annually and updated as necessary.

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4. Water Likely significant

effect

Process and foul effluent discharges

Pollution of surface or groundwater systems from accidental

Description of effect

[mpacts on receiving water quality

Zontamination of surface Nater and groundwater from mexpected events such as spillages and leaks.

love in this report

Mitigation measures proposed by applicant in EIS or I E licence amlication Note 1

On and off-site treatment of process effluent . Off-site treatment of foul effluent. The integrity and water tightness of all underqround pipes will be tested. Storm water run-off from the site will be reduced owing to an approximate 5% reduction in the site's impermeable area.

All storm water run-off will be directed from the development to an interceptor prior to discharge.

Installation of an actuated valve at the end of the storm water discharge drainage system to allow greater control on the release of storm water from the site.

Maintenance of storage facilities and surface water drainage system as per I E licence.

Appropriate bunding as per I E licence conditions.

On-site provision of emergency spill kits .

Appropriate storage of wastes.

Monitoring of surface water discharges as per I E licence.

Completion of fire water Risk Assessment and the retention of storm water on site.

Accident Prevention Procedure and Emergency Response Procedure to be maintained as per I E licence.

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5. Air Likely

sign if ica n t effect

Likely significant effect

Air quality impacts.

Description of effect

Noise & Vibration

Greenhouse gas

Note 1: and/or as outlined

6. Climate

Potential contribution to

Description of effect

emissions.

Installation emissions

global climate change table 7 below

The main noise sources identified include cooling towers and associated pumps, chillers and condensers.

bove in this report

Mitigation measures proposed by applicant in EIS or I E licence application

The RD sets limits for emissions to air from boilers. Low NOx natural gas steam boilers in use. Based on the existing noise levels and noise impact assessment it is predicted that the noise contribution from the installation will not cause a significant negative impact at the nearest noise sensitive locations.

Note 1

Any noise from production/utilities equipment within buildings will be mitigated by equipment design and /or building structure to prevent any external noise impact.

The performance of annual noise monitoring in accordance with I E licence

Mitigation measures proposed by applicant in EIS or I E licence

Note 1

7. Landscape, Material Assets & Cultural Heritage Likely significant

effect

Public utilities

Use of natural resources

Description of effect

Potential impact on availability of electricity, gas, potable water and other infrastructure to other users in the vicinity. Use of aggregate and clean fill at construction stage.

Mitigation measures proposed by applicant in EIS or I E licence application Note 1

Energy efficient measures incorporated at detailed design stage and implemented at operational stage.

Sustainable design principles/measures employed.

Use of clean natural gas and best available technology for steam generation

Where Dossible the recoverv / re-use

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Effects on archaeology

Landscape and visual impact.

Note 1: and/or as outline1

The Limerick county development plan (2010- 16) and the Limerick Environs Local area plan (2010-16) both list Roche castle (protected structure) which is adjacent to the northwest boundary of the installation as a protected structure.

Accidental damage to archaeological landscape including any sub surface archaeological finds or features. Due to the site’s nature as a ‘Brownfield‘ site development and its location in the centre of Raheen Business Park there are few significant landscape or visual impacts.

bove in this report

~

of condensate to minimise water usaqe. The design of the QC laboratory and associated courtyard wi I I acknowledge the overall character of Roche Castle and its outbuildings through the use of appropriate building materials and landscaping.

Recommended that all excavations be fully monitored by a qualified archaeologist

Landscape works including mounding and planting to further ameliorate visual impact and enhance the overall development as planned.

During construction, temporary protection fencing will be used to avoid damage to retained trees within the site and to Roche Castle boundarv.

Assessment of parts 1 to 7and the interaction of eff- and factors

The detailed assessment set out in the preceding sections of this Inspector’s Report fully considers the range of likely significant effects of the activity on human beings, flora, fauna, soil, water, air, climate, landscape, material assets and cultural heritage, as respects the matters that come within the functions of the Agency, (as identified in parts 1 - 7 above), with due regard given to the mitigation measures proposed to be applied. The assessment also has regard to the assessment carried out by the planning authority and all relevant observations and submissions made on the licence application and EIS. The RD includes conditions as considered appropriate to address the likely significant effects of the activity.

The following is a matrix of the potential significant interaction of impacts as provided by Table 15.1 of the EIS (Refer to Appendix 1)

We have considered the interaction between the factors referred to in parts 1 - 7 above and the interaction of the likely effects identified (as well as cumulative impacts with other developments in the vicinity of the activity). The mitigation measures identified above to address individual factors will also address any potential significant interactions.

We are satisfied that the proposed mitigation measures are adequate. I do not consider that the interactions identified are likely to cause or exacerbate any potentially significant environmental effects of the activity. The RD includes conditions as considered appropriate to key interactions associated with the licensable activity. !

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All matters to do with emissions to the environment from the proposed activity, the licence application documentation and EIS have been considered and assessed by the Agency. The assessments carried out by the planning authority and any submissions and observations exchanged between the planning authority and the Agency have been considered as part of this assessment .

Overail Conclusion on Environmental Impact Assessment

We consider that having examined the relevant documents and with the addition of this Inspector's Report that the likely significant direct and indirect effects of the activity have been identified, described and assessed in an appropriate manner as required in Article 3 and in accordance with Articles 4 to 11 of the EIA Directive, as respects the matters that come within the functions of the Agency.

It is considered that the mitigation measures as proposed and the licence conditions included in the RD will not result in a significant detrimental impact on the environment.

It is also considered that the proposed activity, if managed, operated and controlled in accordance with the licence conditions included in the RD will not result in a significant detrimental impact on the environment.

12. Submissions

One valid submission was received in relation to this I E licence application, which is detailed below. This submission was taken into consideration during the preparation of the RD.

Health Service Executive

The Agency received a submission on the 27th May 2014 from Mr. Andrew Curtin, A/Principal Environmental Health Officer, Environmental Health Service, Health Service Executive (HSE), pertaining to the proposed development.

The HSE has no objection in principle to the proposed development and recommends the following:

Noise and Vibration Impacts, Noise and ill-health Construction phase

A study of the existing ambient noise characteristics has been compiled and, due mainly to its proximity to the M20 motorway and resulting background noise, the area does not meet the criteria to be classified as a "Quiet Area" under the EPA NG4 Guidance Note. It is anticipated using modelling, that there will be a moderate negative impact from construction noise, but that this will be short-term in nature as the construction phase will last under 24months.

Predictive modelling of the projected noise during the operational phase has anticipated imperceptive impact from the operational phase due to the background noise of the M20 and the proposed development's location within the Raheen Business Park. However the fact that the outdoor night noise limit of 45dB proposed is above the WHO guidance level would suggest that potential residential development within the vicinity would be curtailed for a t least the period of the planning permission granted. i.e. until 2024

Operational Phase Due again to the background noise of the M20 and the proposed development's location within the Raheen Business Park, predictive modelling of the projected noise during the operational phase has anticipated imperceptible impact from the operational phase.

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Aaencv ResDonse: The impact of noise is discussed under section 6 above. The construction phase is outside the remit of the licence. Annual noise monitoring will be carried out as per condition 6 of the RD.

Air Quality Impacts Construction Phase

No significant air quality impacts are envisaged from the construction phase, other than those normally associated with construction projects. As such, various mitigation measures such as stockpiling of soils, silt screens to contain silt run-off from stockpiles, dust suppression techniques are proposed to reduce the impact on air quality from the construction.

Operational Phase They are of the opinion that overall the predicted modelling indicates that the impact will be long-term negative, but imperceptible.

Aaencv Response: The applicant completed air dispersion modelling which concluded that air emissions from the installation would not have a significant impact on the local environment. The RD specifies limits for emissions to air which are in accordance with the BAT Guidance Note for the Pharmaceutical & Other Speciality Organic Chemicals Sector.

Water/wastewater Impacts The proposed plant will contain a staff canteen to cater for the large number of employees. No details of the grease trap which will treat the wastewater from the staff canteen have been provided. This process shall be clarified and shall be in accordance with the local authority requirements.

Aaencv ResDonse: Condition 5 of the RD requires that “A grease trap shall be installed at the outlet from the canteen prior to entering the site foul sewer.“

13. Cross Office Liaison We liaised with Sean O’Donoghue (IE licensing), Pamela McDonnell (EIA), Dona1 Grant (AA), Marian Doyle and Brian Meaney (baseline report) and Pat Byrne (wastewater). Their advice has been incorporated into the assessment of the licence application.

14. Recommended Determination (RD) The RD specifies the necessary measures; to provide that the installation shall be operated in accordance with the requirements of Section 83(5) of the EPA Act 1992 as amended, and having regard to the AA and EIA. The RD permits the applicant to operate the installation subject to the conditions and schedules specified.

15. Charges The proposed annual charge is €6,606, and is based on the anticipated enforcement effort required for the proposed installation.

16. Recommendation Having regard to the requirements of Section 83(5) of the EPA Act 1992 as amended, I recommend that a Recommended Determination be issued subject to the conditions and for the reasons as drafted in the RD.

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Signed

Dr Tom McLoughlin Bernie Murray Office of Climate, Licensing, Resources & Research

Procedural Note

I n the event that no objections are received to the Proposed Determination of the application, a licence will be granted in accordance with Section 87(4) of the Environmental Protection Agency Act 1992 as amended as soon as may be after the expiration of the appropriate period.

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Appendix 1: Matrix of Environmental Disciplines & Interactions

Interaction

Socio Economics

Socio Landscape & Traffic & Economics Visual Transport

J J I LandscaDe& I J I I

Archaeology,

& Architectural Heritage

J

Cultural Heritage Noise & Air Quality & Flora & Fauna Soils, Geology

Vibration Climate & Hydrogeology

J J

Traffic & J Transport Archaeology, Cultural Heritage & Architectural

J J

I Aaueous I I I

Heritage Noise & Vibration Air Qualitv &

Emissions Waste

J J

J J J

I Management

Climate Flora & Fauna Soils, Geology &

J J J

Water & J J

I I I I J

Emissions

J I

I

J

I J

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