re: response to request for further information from … · according to durr’s ... calculations...

IE0311736-LET-0002_1_01.DOCX

162.TP.15, Issue 7, 10/12/2015

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Project Management Limited t/a PM Group, is a private company limited by shares, registered in Ireland. Company Registration No. 043789. Registered Office: Killakee House, Belgard Square, Dublin 24, Ireland. Directors D Flinter (Chairman), D Murphy (CEO), F Barry, L Foley, B Gallagher, H Keelan, S Kelly, M Lynam, JC O’Connell, L O’Mahony, A Schouten (British), M Shelly, L Westman Secretary J Sheehan Template Ref: 162.TP.15

PM Group

Killakee House

Belgard Square

Dublin 24

Ireland

Our Reference: IE0311736-LET-0002 20 April 2016 Ms Grainne Oglesby Administration Officer Office of Climate, Licensing and Resource Use EPA PO Box 3000 Johnstown Castle Estate Co. Wexford

Re: Response to Request for Further Information from the

EPA relating to Rottapharm Ltd. Industrial Emissions Licence Review (P0886-02)

Dear Ms Oglesby, The following information provided is in response to the request for further information from the EPA to Rottapharm Ltd. on 10 March 2016, relating to the Industrial Emissions Licence review application (Ref. P0886-02). PM Group is responding on behalf of Mr. Jesus Caballo, EHS Manager at Rottapharm Ltd. Each item requested is answered in turn, with attachments to this letter as required. 1. As required under Regulation 9(2)(k), and having regard to the relevant information in the EIS and submitted with the application, provide an impact assessment of the likely significant direct and indirect effects of the activity on the environment, as respect matters that come within the functions of the Agency for the following factors:

a. Human beings (please include an assessment of the impact(s) of safety issues from accidents) and

b. An assessment of the interaction between the factors (human beings, flora fauna, soil/groundwater, surface water, air, climate and landscape, material assets and cultural heritage) and the interaction of the likely effects identified.

Response Please see the relevant assessments in Attachment 1 to this letter. 2. Provide air dispersion modelling to determine the impacts of VOC emissions from the RTO (A2-1) from your installation based on the proposed increase in maximum flow rate (Regulation 9(2)(k). Response Air dispersion modelling of VOC emissions has been carried out at the corrected maximum flow rate. The assessment and report carried out by ARUP is included in Attachment 2 to this letter. 3. Determine whether a ‘cumulative impact assessment’ is necessary, taking into account the nearby installations to your installation. The approach outlined in Figure A2 of Appendix F of OEE Air Dispersion Modelling from Industrial Installations Guidance Note (AG4), EPA 2010, should be followed to determine whether cumulative impact arising is significant (Regulation 9(2)(k)).

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2

Response A determination for cumulative assessment is included in the VOC air dispersion modelling assessment and report carried out by ARUP, which is included in Attachment 2 to this letter. 4. Provide details of the test programme carried out for the RTO (emission point A2-1), including the reference oxygen content agreed by the Agency and confirm the minimum RTO temperature and residence time (Regulation 9(2)(g)). Response The test programme previously submitted to the EPA, dated 18

th January 2011,

has been included in Attachment 3 of this letter. Previously the total volumetric flow rate from the RTO in the test programme of 18,900m

3/hr did not match the

volumetric flow rate in the Industrial Emissions Licence due to an error in the information provided for the original licence application. The licence review application seeks to correct this error, therefore the test programme and the licence will be compatible. It is noted that in Table 2 of the test programme the inlet air flow rate is related to one operational coater. There are three coaters at the facility using solvent, hence the 18,900m

3/hr total volumetric flow rate, including 5% safety

factor. Minimum RTO temperature: According to Durr’s (RTO vendor) basis of design for the Ecopure® RTO, the minimum temperature for safe off-gas disposal is 750°C, as is also outlined in BS EN 746-2:2010. If the temperature falls below 750°C a hard-wired interlock will stop off-gas disposal immediately. Note: A “Ready for Disposal” temperature of 780°C is also set; whereby when the RTO is coming from heating mode (starting up) at 780°C the RTO control system allows off-gas disposal. If after that, the temperature drops below 780°C a timer is started and after the time elapses the off-gas disposal is stopped (software interlock). Minimum residence time: The minimum residence time for the Rottapharm Ecopure® RTO is 0.5 seconds. Durr confirmed that this residence time was obtained from the combustion calculations carried out during the design and taking into account worst case scenario of maximum air flow provided by the fan through the RTO. The minimum residence time is a design parameter and therefore is neither measured nor recorded. 5. Provide details of the ground water monitoring wells on-site, including a map with grid references, as agreed under Condition 3.12 of your current licence (P0886-01) (Regulation 9(2)(j)). Response There are 4 No. ground water monitoring wells on-site, as established in accordance with licence requirements, as follows: GW1 – 305451E, 241441N GW2 – 305566E, 241244N GW3 – 305511E, 241345N

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3

GW4 – 305487E, 241204N The following are the details of these wells. A map showing the location and grid references of the wells is included in Attachment 4 to this letter. Ref Date

Installed Driller Method Borehole

Elevation (m)

Borehole Diameter (mm)

Installation Diameter (mm)

Slot Size

GW1 12/07/10 Geotron Rotary / Water Flush

61.28 150 50 Nominal


61.51 150 50 Nominal


59.34 150 50 Nominal

GW4 04/08/11 Glover Symetrex N/A 150 50 Nominal

6. Clarify whether the interceptors on-site are full retention or bypass separators (Regulation 9(2)(g)). Response The following table outlines the details of the interceptors at the Rottapharm Ltd site. Interceptor Location Class Type

Car park Class 1 By-pass

Car park extension (2015) Class 1 By-pass

Admin building (Access road & staging area )

Class 1 Full retention

From east of site Class 1 By-pass

Warehouse loading bay Class 1 Full retention

7. In addition to the above please also provide an updated non-technical summary to reflect the information provided in your reply. Response An updated non-technical summary is provided in Attachment 5 to this letter.

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IE0311736-LET-0002_1_01.DOCX

162.TP.15, Issue 7, 10/12/2015

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Attachment 1 Human Beings and Interaction Assessments

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PM GROUP

Rottapharm Ltd Industrial Emissions Licence Review

IE0311736-REF-0026, Issue 1 19/04/2016

IE0311736-REF-0026_1_01.DOCX Page 1 of 13

1 Population and Human Health

1.1 Introduction

This assessment describes the existing human environment in the vicinity of the Rottapharm Ltd. facility in terms of population, employment and land-use. The likely impacts on the human environment due to the development are assessed.

The site of the development is located at Damastown Industrial Park, Mulhuddart, Dublin 15. The development, which is currently developed and operating, has already resulted in a positive impact in terms of local employment and stimulating economic activity. The facility was developed in accordance with the original planning permission received in 1998 (Planning Ref. F98A/0312). As part of this planning application and Environmental Impact Assessment was carried out and an Environmental Impact Statement was included in the planning application documentation.

Since the original EIS a number of further planning applications and developments have been carried out on-site. It is noted that these developments on the site have not led to a change in the type of activity on site or the type of land use and did not require an EIS.

1.2 Assessment Methodology

Analysis of the effect of the proposed development on the human environment is undertaken in compliance with the requirements of “Guidelines on the Information to be contained in Environmental Impact Statements” (EPA, 2002) and “Advice Notes on Current Practice (in the preparation of Environmental Impact Statements)” (EPA, 2003). Consideration was also given to the draft Revised Guidelines on the Information to be contained in Environmental Impact Statements (Draft September 2015) and the draft Advice Notes for Preparing Environmental Impact Statements (Draft September 2015).

This assessment is focused on potential impacts which have not been assessed elsewhere in the original EIS for the development, submitted under planning ref. F98A/0312. The Advice Notes on Current Practice identify issues which may be examined under assessment of impact on human environment as being:

- Economic Activity – will the development stimulate additional development and / or reduce economic activity, and if either what type, how much and where?

- Social Considerations – will the development change patterns and types of activity and land use?

- Land use – will there be severance, loss of rights of way or amenities, conflicts, or other changes likely ultimately to alter the character and use of the surroundings?

- Tourism - will the development affect the tourism profile of the area?

- Health & Safety – will there be risks of death, disease, discomfort or nuisance?

The Advice Notes recommend that an EIS assessment indicates the location of sensitive neighbouring occupied premises likely to be directly affected and other premises, which although located elsewhere, may be the subject of secondary impacts such as alterations to traffic flows or increased urban development, with particular reference to the following:

- Homes

- Hospitals

- Hotels and holiday accommodation

- Schools and rehabilitation workshops

- Commercial premises.

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IE0311736-REF-0026, Issue 1 19/04/2016


The EPA Advice Notes also recommend that impacts on the transient population are considered, such as drivers, tourists and walkers.

In line with the advice notes, before assessing the impacts on the human environment, the principal receptors that may be impacted by the proposed development are identified as:

Residential Receptors

- Residential properties within 1 km of the site

- Residential properties adjacent to the primary transport routes

- Residential properties in the wider context

- Land zoned for residential development.

Direct Economic Receptors

- Commercial and Industrial premises in close proximity to the site

- Zoned commercial lands in close proximity to the site

- Operational and construction related employment.

Indirect Economic Receptors

- Suppliers of construction materials

- Spin off employment and economic activity.

Social and Community Facilities

- Schools and community facilities within 1 km of the site

- Lands zoned for social and community facilities within 1 km of the site.

Transient Population

- Visitors to Damastown Industrial Park.

Relevant information has been obtained from public bodies with regard to planning and development context, employment statistics, demographic statistics and community aspects. The primary bodies concerned were the Central Statistics Office (CSO) and Fingal County Council (FCC).

Desktop information reviewed in the process of information gathering includes the following:

- CSO data, including the censuses for 2006 and 2011; the Quarterly National Household Register; Live Register figures

- Fingal Development Plan 2011-2017

1.3 Characteristics of the Development

The current Rottapharm development on the site at Damastown Industrial Park is a pharmaceutical facility that manufactures primarily solid oral dosage products and bulk active material. It is a fully integrated facility incorporating manufacturing, packaging, warehousing, laboratory facilities, utilities and office accommodation. The Rottapharm Ltd facility in Dublin consists of two discrete buildings: Administration and Production / Warehouse linked by enclosed corridors. Construction was completed in 1999.

The Administration building is a 2-storey steel framed building with a precast concrete first floor and metal deck roofing. The Production building is composed of a steel structure with metal deck roofing and a concrete slab in parts of the first floor to support plant and equipment servicing the production facility. The Warehouse is a single storey steel structured building with a long span roof truss and a combination of block work with architectural sheeting to the perimeter walls.

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IE0311736-REF-0026, Issue 1 19/04/2016


There are approximately 175 employees on the Dublin site. The facility normally operates a 2-cycle shift: 7am-3pm and 3pm-11pm, 5 days a week, with regular overtime working on Saturdays and Sundays, however Production and Packaging may operate 24 hours/5 days or 24 hours/7 days cycles depending on operational needs. Office hours are from 8am to 5pm.

As noted in Section 1.1, since the original EIS a number of further planning applications and developments have been carried out on-site. Table 1.1 outlines the planning history for the site.

Regarding the Human Environment, the types of issues which developments such as this raise (during operation) include, additional economic opportunities, increased traffic, and impacts on existing and adjoining land uses.

1.4 Receiving Environment

The existing human environment in relation to the development comprises those residing and working in the vicinity of the site and also the wider community in Fingal, and Dublin City. Figure 1.1 shows the existing and zoned land uses in the surrounding area.

1.4.1 Local Residences and Businesses

The site of the Rottapharm Ltd. facility is within the Damastown Industrial Park. The surrounding lands are either developed or undeveloped commercial / industrial areas within the industrial park. Neighbouring businesses include Clarochem, Astellas Pharma, Mallinckrodt Medical Imaging, Helsinn Pharmaceuticals to the west, Masterlink Logistics and Geodis Logistic to the north, and Flood Recycling and The Tech Group to the east. To the south of the site leads to the M3/N3 national route and motorway.

The nearest residential area within 1km of the site, Pheasant Run area, is located approximately 500m to the south of the Rottapharm Ltd. facility across the N3/M3. There are other areas within 1km of the site to the east of the site at Avondale Court, Avondale Park and Parslickstown Gardens, which are approximately 900m from the site.

The site is well served by the local road network with access to the site from the Damastown Road, where quick access to the M3/N3 route is available. There are two entrances to the site, one for staff and visitors and the other for deliveries and removals from site.

1.4.2 Amenities and Tourism

The site is situated to adjacent a number of existing commercial and industrial facilities in an area that has been zoned for general enterprise and employment use only.

The nearest large amenity facility to the site is the Tolka Valley Park which is located to the south of the Rottapharm site and extends south eastwards as far as Blanchardstown. Another amenity area in the general area is the Blanchardstown Shopping Centre, which is located approximately 2.2km to the southeast of site. There are a number of small parks in the general area also within housing estate areas.

In relation to other potential receptors such as hospitals and rehabilitation facilities, hotels and holiday accommodation, and schools, there are none within the vicinity of the development site.

1.4.3 The Wider Community

In order to assess the potential effects of the project on the wider community it is first necessary to establish the demography of the population. Attributes of the population which are examined in this assessment include population, age profile including dependency, employment profile and social class.

Data on these elements have been compiled from the 2006 and 2011 censuses, as well as some information from Quarterly National Household Surveys, all of which are compiled by the CSO.

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IE0311736-REF-0026, Issue 1 19/04/2016


Table 1.1: Site Planning History

Planning or Appeal Reference Number

Planning Authority / An Bord Pleanála

Date of Planning Decision (Final)

Brief Description EIS Required with Planning Application

F98A/0312 Fingal County Council

15/07/1998 A Pharmaceutical Finishing Plant, incorporating Manufacturing Areas, Warehousing Offices, Laboratory, and Utility Areas. Damastown, Mulhuddart, Dublin 15

Yes


09/06/2004 Install temporary accommodation comprising a single storey modular building of 95m

2 for use as offices, to install a fire escape single door on the east side

of their existing building and to construct 11 additional car parking spaces with an area of 138m

2.

No


26/04/2005 Expand existing car parking facilities by the construction of an additional car park to accommodate 102 cars at the facility in Mulhuddart.

No

F05A/0114/E1 Fingal County Council

03/03/2010 Extension of planning permission expiry only. No


31/05/2006 Construction of new single storey 49.95m² extension, with three no. roof lights, to existing canteen in existing two storey Administration Building forming part of pharmaceutical production facility.

No


21/08/2008 Construction of a 3992m2 expansion to our existing warehouse and

production building. The expansion will consist of a 2160m2 x 14.7m high

single storey Warehouse, a 150m2 x 6.2m high single storey Production

Office, a 1080m2 x 10.7m high single storey Production Area with an

adjoining 80m2 x 4.8m high access corridor and a 522m

2 x 6.2m high single

storey Product Storage Area. The development will be constructed as an expansion of the existing building located along the north and east faces. The development will also consist of the construction of a Fire Tender Access Road around the proposed expansion, an additional dock leveller and associated landscaping works.

No

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IE0311736-REF-0026, Issue 1 19/04/2016


Planning or Appeal Reference Number

Planning Authority / An Bord Pleanála

Date of Planning Decision (Final)

Brief Description EIS Required with Planning Application

F08A/0483/E1 Fingal County Council

31/05/2013 Extension of planning permission expiry only. No

FW13A/0084 Fingal County Council

21/10/2013 The development will consist of the construction of a first floor internal production area (384 m

2) within the footprint of the existing facility, the

construction of a roof level plant room enclosure of 143 m2 X 5.3m high

above the production area and an enclosed access stairs to access the plant room of 6 m X 3.5 m X 13.9 m high all to the rear of the existing facility. This application relates to development on a site which comprises an activity requiring an integrated pollution prevention and control licence.

No

FW15A/0088 Fingal County Council

29/09/2015 Permission for the construction of a single storey 8.8m wide x 12.97m long x 3.75m high extension with a floor area of 105m

2 to the existing canteen to the

South West corner of the existing two storey administration building, the construction of a 52 no. car space car park expansion to the North of the existing car park, and associated works. This application relates to development on a site which comprises an activity requiring an integrated pollution prevention and control licence.

No

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Provide for d1stributt0n, w,rehou~. sto~ge and k)sistia facilities which require good xcess to I major road ~ within a good quality tnvirontMnt

Provide for res.dent~ developmfflt and protect and improve resldtntial amenity

Protect and p«>m0tt in a balanced way, t~ dew~pment of ,cticulture and rural-re-lated enterprise, biodtverstty, the rur~ landsYpe, and the bu1tt and cultural heritage

Protect 1nd promote the charKter of the Rural Vllige and promote a Vibrant community In accordance with an approved k>ul aru pbn. and the av11l1bility of physk:11 and community Infrastructure

Pre~ and provide '°' open space and rKrtatiONI amenities

Provide for new rnidenu,I communities In KCOrdlnce with approved loQl a,ea pl,1ns and subject to the provisk>n of the nectSS¥y soct,I and physlul infrastructure

Provide for and faatltate rurakiP!ated busuwu which has a domonSlra<ed nffd tor • rwal Jocatlon

Protect~ provide for 1tf'ld/Ot Improve local centre facilitlt-s

f>rov;df fOt hHvy lnduSl,Y

Provide for offKt, research and devielopment and high tfChnolclv/h,ch tfChnoloSY manufa<turinc type •mpl0ym•nt In• ~gh qu,hty butlt and landscaped enY)ronment

Protect and enhance high amenity arus

Provide opportunities for general entefprise and emplovment

Protect and pnMde for a Grttnbt'tt

Provide for and protect CM(, rellp)us, community, educatfOO, hHlth Yre and social lnfrasuuct:ure

Objective WO

Objecthlf RU

Objective RB

Objective RA

Object,vfOS

Objective LC

ObjectJYOHI

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IE0311736-REF-0026, Issue 1 19/04/2016


Figure 1.1: Landuse Zoning Objective (Source: Fingal Development Plan 2011 – 2017 Sheet 12 Blanchardstown North) (approximate site boundary outlined in red)

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IE0311736-REF-0026, Issue 1 19/04/2016


1.4.4 Census

The most recent censuses of population were carried out in April 2011 and April 2006 by the CSO. Census data is compiled for the State as a whole, as well as smaller areas including counties, cities, towns and electoral divisions. Given the location of the development the census information on population, age profile, employment and social class, has been analysed with respect to the State, Dublin and Fingal.

Population

Table 1.1 reveals the population increase that has occurred in the general vicinity of the development between 2006 and 2011. Increases have occurred in all the relevant catchment areas, with a significant percentage increase occurring Fingal area. The site is located in the catchment area covered by the Fingal Development Plan 2011-2017.

Table 1.1: Populations in Vicinity of Development, 2006 and 2011

2006 2011 % change

State 4,239,848 4,588,252 8.2

Dublin 1,187,176 1,273,069 7.2

Fingal 239,992 273,991 14.2

Age Profile

Table 1.2 reveals that in 2006 and 2011 a higher percentage of the population of Dublin and Fingal were independent, than were independent in the State. In addition the percentage of Dublin and Fingal’s population which was of child-bearing age was also moderately higher than the same group within the State as a whole. These figures indicate that the population and labour force of these areas is likely to increase faster than that of the State, which would suggest that employment opportunities will be required to keep pace with population and labour force future growth.

Table 1.2: Age Profile of Population in the Vicinity of the Development

2011 0-14 15-44 45-64 65+

% Dependant

(0-14 & 65+)

% Independent

(15-64)

% Child Bearing (15-44)

State 979,590 2,030,390 1,042,879 535,393 33.0 67.0 44.3

Dublin 245,252 617,851 270,690 139,276 30.2 69.8 48.5

Fingal 66,407 132,931 54,792 19,861 31.5 68.5 48.5

2006 0-14 15-44 45-64 65+

% Dependant

(0-14 & 65+)

% Independent

(15-64)

% Child Bearing (15-44)

State 864,419 1,978,605 928,868 467,926 31.4 68.6 46.7

Dublin 217,652 602,022 244,991 122,511 28.7 71.3 50.7

Fingal 52,974 126,178 46,445 14,395 28.1 71.9 52.6

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IE0311736-REF-0026, Issue 1 19/04/2016


In all areas, there has been a relatively minor decrease in the independent and of child-bearing age population between 2006 and 2011. The independent population of the State decreased by 1.6% between 2006 and 2011, while the independent populations of Dublin and Fingal decreased by 3.4% and 1.5% respectively, over the same period. The population of child-bearing age decreased in the State by 2.4% between the 2006 and 2011 census while there were decreases of 2.2% and 4.1% for the same group in Dublin and Fingal respectively, over the same period.

Employment

Table 1.3 reveals the employment statistics for Dublin and Fingal. It is clear that there has been a significant increase in unemployment in both areas, as well as the State as a whole, between 2006 and 2011. Therefore there is a need for employment opportunities and sustained employment in the vicinity of the development.

Table 1.3: Employment Statistics for Vicinity of Development

2011 – Labour Force

At work

Unemployed looking for first regular

job

Unemployed having lost or given up previous job

Total in Labour Force

Unemployed as % of Total Labour Force

State 1,807,360 34,166 390,677 2,232,203 19.0

Dublin 540,729 10,678 100,771 652,178 17.1

Fingal 119,276 2,224 20,416 141,916 16.0

2006 – Labour Force

At work

Unemployed looking for first regular

job

Unemployed having lost or given up previous job

Total in Labour Force

Unemployed as % of Total Labour Force

State 1,930,042 29,372 150,084 2,109,498 8.5

Dublin 572,896 9,355 46,750 629,001 8.9

Fingal 120,794 2,095 7,927 130,816 7.7

Social Class

Census information on employment can be further categorised by social class (Table 1.4). This categorisation indicates the type of employment that the national workforce is employed in or is capable of being employed in. The seven different classes are described as follows:

1. Professional workers

2. Managerial and technical

3. Other non-manual workers

4. Skilled manual workers

5. Semi-skilled manual workers

6. Unskilled manual workers

7. All other gainfully occupied and unknown

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IE0311736-REF-0026, Issue 1 19/04/2016


For this analysis of social classes within the areas of interest, social classes 1-3 have been grouped together as these include most professional and non-manual workers. Social classes 4-7 are also grouped together and include semi-skilled and unskilled employees.

Table 1.4: Social Classes of Population in the Vicinity of the Development

2011 – Social Classes

Social Class 1-3 (%) Social Class 4-7 (%)

State 52.1 47.9

Dublin 56.2 43.8

Fingal 59.0 41.0

2006 – Social Classes

Social Class 1-3 (%) Social Class 4-7 (%)

State 49.9 50.1

Dublin 53.4 46.6

Fingal 57.2 42.8

Between 2006 and 2011, in all catchments of interest, the percentage of the populations which fall into social classes 1-3 increased. This suggests that in terms of labour force the Dublin and Fingal areas has a significant requirement for, and is capable of supporting industries with a need for professional, managerial and non-manual employees i.e. Class 1-3, such as Rottapharm Ltd.

1.4.5 Quarterly National Household Survey

The Quarterly National Household Survey (QNHS) is a large-scale, nationwide survey of households in Ireland in which 39,000 households are surveyed each quarter.

It is designed to produce quarterly labour force estimates that include the official measure of employment and unemployment in the State. The most recent Quarterly Survey for which results have been published was undertaken in Quarter 4 (Q4) of 2015.

Main Results

In the State as a whole there were 1,983,000 persons in employment and 187,500 unemployed in Q4, 2015 making up a labour force of 2,170,500. This represents an increase in employment of 44,000 in the year to Q4 2015. There was an increase in labour force of 18,000 in the year to Q4 2015.

The latest available comparable figures for all EU-28 (28 EU member states) and Irish employment figures are for Quarter 3 (Q3) of 2015. The employment rate in Ireland increased by 1.6%, to 63.8% over the year to Q3 2015, while the employment rate in the EU-28 was 66.1%.

1.4.6 Summary

In summary the preceding data indicates that Fingal and Dublin, as well as the State as a whole, have seen rises in population between 2006 and 2011. In addition the independent and child-bearing percentages of the population are considerably higher in Fingal and Dublin than in the State as a whole, which is indicative of the area’s need for current and future employment opportunities.

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Social Class statistics for the area also indicate that a high percentage of the population of Fingal and Dublin fall within Social Classes 1-3 which comprise professional, managerial and non-manual workers. Therefore there exists in this region a significant requirement for employment in similar categories, such as is provided by Rottapharm Ltd.

1.5 Potential Impacts

1.5.1 Impacts on Local Resident and Businesses

The main potential impacts on local residences and businesses associated with the proposed development relate mainly to traffic, noise, air emissions and visual impact. All of which are dealt with in the corresponding sections of the EIS that was submitted with the original planning application (Planning Ref. F98A/0312), as follows

- Section 7.4 Air & Climate

- Section 7.5 Noise

- Section 7.8 Roads

- Section 7.9 Visual Impact

As part of the licence review application recently submitted to the EPA an EIA Screening Report (PM Group Report No. IE0311736-22-RP-0004) was included. This assessed any potential impacts due to subsequent developments since the original EIS. It concluded for the aspects above that no further significant impacts result from the expansion projects since the original development. The relevant conclusions are as follows:

Air & Climate

As part of the expansion projects at the facility since the original EIS was prepared, all emissions to atmosphere are considered to be minor in accordance with EPA guidelines; therefore it is considered that these projects do not have the potential to have any significant impacts to the environment in addition to the potential impacts outlined in the original EIS. Also, it is not considered that the expansion projects were of a size or nature that could have an impact on climate.

Noise

There have been no significant changes to the number and nature of noise emissions since the original planning application. There are no new significant external noise sources associated with any of the changes on-site. Therefore it is concluded that any noise sources installed at the facility since the original planning application for the site do not have the potential to have a significant impact on local residents in addition to the impacts outlined in the original EIS.

Roads

As a material asset the road network serving the site is an important resource to the local residents and businesses. Given the scale and nature of the expansion projects on site it is concluded that there is no significant impact to the roads network.

Visual Impact

The expansion projects that have taken place at the site have consisted of small extensions to the various buildings on site, as well as extensions to the car park on site. It is not considered these projects have had a significant impact on the landscape character of the area, and it is considered that they have had a minimal impact on views of the site from both short range and long range given the site’s location within industrially zoned land and the fact that other industrial facilities are located in close proximity to the Rottapharm Ltd. site.

It is also noted that the facility has an Industrial Emissions Licence (Licence Reg. No. P0886-01) from the EPA, which regulates and monitors all emissions from the facility ensuring that the site is operated in such a way as to not impact significantly on the environment and human health.

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In addition a positive impact for local businesses of the site is the additional economic activity that is created in the local area, especially for businesses in the vicinity of the site and surrounding area in Dublin. 175 people are employed at the site for the operation of the facility and their use or on-going potential use, both personal and business-related, of local services and retail and leisure facilities greatly benefits the business community in the area.

1.5.2 Impacts on the Wider Community (Socio-Economic)

Construction Phase

The facility is fully constructed and therefore there are no current predicted significant impacts, positive or negative, associated with the construction phase. A recent canteen extension at the facility has recently been completed.

Operational Phase

Overall, the development has an on-going positive impact on the human environment as it provides both temporary and permanent employment and contributes to the local economy.

The site currently employs 175 persons. The facility requires a variety of employment disciplines including scientists, engineers, manufacturing, warehousing, drug packaging and labelling staff and administration staff. Spin-off jobs result from the employment created as a result of the operating facility due to the “multiplier effect”. Therefore there is a positive impact in terms of further employment in the wider area in the services industry or other.

The impact on housing demand arising from the operation of the development is likely to be dispersed over a wide area including Dublin and the Greater Dublin Area and surrounding counties. No adverse housing demand impacts are likely to be or have been associated with the operation of the facility.

1.5.3 Impacts on Zoning and Land Use

The facility is located on lands that are zoned GE (Provide opportunities for general enterprise and employment) in the Fingal Development Plan 2011 – 2017 and therefore is compliant with local authority zoning objectives. Operational access to the proposed development is via the Damastown Road to the south of the site. The development has not caused any severance issues or loss of rights of way for local landowners/land users.

1.5.4 Impacts on Health and Safety

No significant potential health and safety risks to people living and working in the vicinity of the operational plant were identified in the various relevant sections of the original EIS for the facility. Furthermore, no significant effects were identified in the EIA Screening Report submitted with the licence review application, which assessed all developments that have been carried out on-site since the original development.

This section considers any additional potential health and safety risks to the human environment arising from the development.

Construction Phase

There is no construction on-going at the site and therefore no predicted impact due to construction at the site.

Operational Phase

The main hazards at any operational site are related to the equipment and materials stored and used at that site. The facility is designed to comply with regulatory requirements for pharmaceutical facilities under current Good Manufacturing Practices (cGMPs). The facility is also designed to meet all other regulatory standards covering applicable health, safety and environmental requirements. Amongst which an Industrial Emissions Licence, which is place, and is currently under review with the EPA.

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It is noted that the site is not a SEVESO site, i.e. it does not come under the remit of the Chemicals Act (Control of Major Accident Hazards involving Dangerous Substances) Regulations 2015.

1.5.5 Impacts on Local Amenities and Tourism

The facility is situated adjacent to a number of existing commercial and industrial facilities, in an area that has been zoned for general enterprise and employment use only. As a result of this the impact of the facility on local amenities and tourism is minimal.

The nearest large amenity facility to the proposed site is the Blanchardstown Shopping Centre which is located to the southeast of proposed development site. Through good design and engineering practices there have been no negative impact on this amenity as a result of the development.

It is considered that during on-going operation the facility has and will have a beneficial impact in the locality in terms of creating business for the local commercial sector.

1.5.6 Cumulative Impacts

Much of the surrounding lands is either established enterprise or zoned for similar development. Therefore potential exists for further development on either existing sites or proposed sites.

The current developments situated in the area have led to a significant number of temporary jobs during construction and permanent jobs during operation which substantially benefit the local economy. This has a positive cumulative impact with the employment currently provided by other businesses in the area.

It is noted that the current Industrial Emissions Licence is under review in order to correct the volumetric flow rates from the Regenerative Thermal Oxidiser (RTO). An air dispersion model has been carried out and has determined that there is no requirement for a detailed cumulative assessment of air emissions, therefore there are no predicted significant cumulative impacts in that regard.

1.6 Mitigation Measures

Many of the potential impacts on the human environment relate to other environmental aspects such as noise, air, water quality, waste and traffic. Of the remaining potential impacts relating to the human environment as outlined in Section 1.5 only those concerning health and safety require mitigation measures. These are outlined in the following sections.

1.6.1 Construction Health and Safety

The recent construction of the small canteen extension on-site was managed in accordance with the Safety, Health & Welfare at Work (Construction) Regulations, 2013. Safety is a primary concern during the construction phase of any project on-site.

Any potential temporary contractor facilities and areas under construction in the future will be enclosed and fenced off from the public with adequate warning signs of the risks associated with entry to these facilities. Entry to these areas will be restricted and kept secure when construction is not taking place.

1.6.2 Operational Health and Safety

The operation of the facility is carried out in strict accordance with all Irish and European regulations governing safety in the work place and in particular the regulations implemented under the Safety, Health & Welfare at Work Act, 2005, as amended.

All relevant facility employees are fully trained in the operating procedures for equipment and processes, with particular emphasis on related health and safety issues.

In the event of a fire the extensive building sprinkler systems will come into operation and necessary personnel will be fully trained to deal with such emergencies. In addition the buildings

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are designed so that any fire will be contained within its zone by a fire wall in order to prevent it spreading and therefore any damage and impact will be localised. Rottapharm Ltd. operate an Emergency Response Procedure in the unlikely event of an accident or emergency. The procedure includes responses during normal working hours and outside normal working hours.

1.7 Residual Impacts

The main residual impact of the development on human beings is a long term positive economic and employment effect, contributing to the local economy.

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1 Interactions and Cumulative Impacts

1.1 Introduction

An important aspect of assessing the environmental impacts associated with any development is to consider how impacts identified under each of the subject headings might interact. Similarly, consideration must also be given to the cumulative effects arising from the interaction of the project with impacts arising from developments in the area.

This chapter considers the impacts which occur as a result of the interaction of impacts, or through cumulative or indirect impacts.

The examination of these impacts is important as an impact which directly affects one environmental medium may also have an indirect impact on other media (sometimes referred to as cross media impacts). This indirect effect can sometimes be more significant than the direct effect.

Impact inter-relationships or interactions are the reactions between impacts within a project and the inter-relationship between impacts identified under one environmental topic with impacts identified under another environmental topic.

Cumulative impacts are impacts which occur as a result of incremental changes caused by other past, present or reasonably foreseeable actions together with this project.

Indirect impacts are impacts on the environment which are not a direct result of the project, produced some distance from the project or as a result of a complex pathway.

1.2 Assessment Methodology

This assessment has been prepared in accordance with the EPA ‘Guidelines on the information to be contained in Environmental Impact Statements’, 2002 and with the EPA ‘Advice Notes on Current Practice (in the Preparation of Environmental Impact Statements)’, 2003. Consideration was also given to the draft Revised Guidelines on the Information to be contained in Environmental Impact Statements (Draft September 2015) and the draft Advice Notes for Preparing Environmental Impact Statements (Draft September 2015).

1.3 Interaction of Impacts

This section addresses potential interactions between the various impacts identified in the individual chapters of the original EIS and also considers all subsequent developments on the site. This assessment should be read in conjunction with the original EIS and also with the EIA Screening Report submitted with the Industrial Emissions Licence review application (PM Group Report No. IE0311736-22-RP-0004). Table 1.1 shows a matrix of the environmental disciplines and where potential interactions could occur. The matrix is developed based on knowledge of the Rottapharm Ltd. site and the surrounding area.

These potential interactions have been examined and a number of areas have been identified where further consideration is required in addition to the potential impacts dealt with in the EIS itself. These are addressed in the following sections.

1.3.1 Socio-Economic Factors

Visual Impact

The visual impact of the development has the potential to impact on human beings resident in the locality. However this potential impact has been mitigated by the following factors:

- As part of the development landscaping and planting of native species, as well as the design of terraced landscaping around the focal point of the Pinkeen River, which flows through the site, offsets the potential impact to the human environment due to the development.

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- Raised earthen berms around the perimeter of the site also screen the site from the surrounding human environment and potential receptors.

Overall, in terms of the interaction between the visual impact and the human environment, the EIS predicts that the visual impact is one of improving and enhancing the environment of the area.

Roads

Increased trip generation due to the development can potentially lead to road and junction congestion, which can impact on the human environment and business. In terms of the Rottapharm facility, the trip generation is relatively low, and given the capacity of the road network serving the site, there is no predicted significant impact.

Noise

Increasing industrial activity has the potential to increase ambient noise levels at nearby sensitive receptors for people, for example dwellings and amenities. It is considered that the facility as it currently operates does not constitute a noise nuisance in the area. Periodic noise monitoring is carried out for EPA reporting.

Air & Climate

Increased industrial emissions have the potential to impact on air & climate and ultimately impact on the human environment in the vicinity and wider area. Emissions from the Rottapharm facility are control under an Industrial Emissions Licence from the EPA. Modelling of emissions has shown that there are no predicted significant impacts resulting.

1.3.2 Visual Impact

History & Archaeology

The visual impact of the development has the potential to impact on the historical amenity of an area where views to and from recorded monuments are adversely affected. There are no known archaeological features in the area and no potential impact to history & archaeology is predicted.

1.3.3 Roads

Air & Climate

The additional traffic generated in the locality as a result of the development is negligible, in relation to the capacity of the surrounding road network. Given the relatively low staff numbers the development is predicted to have a negligible impact on local air quality due to vehicle emissions.

Noise

In consideration of the overall development it is predicted that there would be no impact in relation to the noise environment. Given the fact that the noise from the N3/M3 route is the dominant source of noise it is considered that the noise from traffic movements due to the development is negligible and does not have a significant impact on the environment and human health.

1.3.4 Groundwater & Soil

Flora & Fauna and Water

Potential interactions that exist, for example, could be the resulting contamination of groundwater & soil due to the uncontrolled spillage of wastes, e.g. waste chemicals, at the site. This will be avoided through correct storage of materials in bunded containers/areas, where required, and the use of qualified licensed waste contractors. Any potential spillage and pollution of groundwater & soil has the potential to interact with the water environment and ultimately on the flora & fauna in that environment. It is noted that there is no direct discharge to groundwater from the site. Furthermore, all surface water passes through the site oil separators, which ensures that any negative impacts are avoided. Only clean, uncontaminated surface water is released from site to the Pinkeen River.

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Wastes

The poor storage, handling and transport of wastes have the potential to lead to impacts to groundwater and soil due to potential spillage and resulting contamination. The design of the facility and the use of appropriately licensed contractors ensure that wastes, e.g. waste chemicals, are not discharged to the groundwater and soil environment at the site.

1.3.5 Flora & Fauna

Water

As per groundwater and soil, potential interactions include where the water environment, Pinkeen River, is contaminated by the site resulting in impacts to flora and fauna. This will be avoided through correct storage of materials in bunded containers/areas, where required, and the use of qualified licensed waste contractors. Furthermore, all surface water passes through the site oil separators, which ensures that any negative impacts are avoided. Only clean, uncontaminated surface water is released from site to the Pinkeen River.

Air & Climate

Increase air emissions can lead to potential impacts to flora and fauna through pollutant deposition or climate change. Emissions from the Rottapharm Ltd. facility are control under an Industrial Emissions Licence from the EPA. Modelling of emissions has shown that there are no predicted significant impacts resulting.

1.3.6 Material Assets

Water

Potential impacts to the water environment due to water use and potential uncontrolled emissions to surface waters has the potential to impact that material asset for the immediate and wider area. As outlined above this will be avoided through the correct storage and handling of materials, as well as other protective design measures, such as oil separators.

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Table 1.1: Matrix of Environmental Disciplines and Interactions

Interaction Socio-

Economic Factors

Visual Impact

Roads Groundwater

& Soil

Flora &

Fauna Noise Water

Air & Climate

Wastes Material Assets


Socio-Economic Factors

Visual Impact

Roads

Groundwater & Soil

Flora & Fauna

Noise

Water

Air & Climate

Wastes

Material Assets


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1.4 Cumulative Impacts

The site of the development is within the Damastown Industrial Park, surrounded by industry. Existing facilities that are in the Park include Clarochem, Astellas Pharma, Mallinckrodt Medical Imaging, Helsinn Pharmaceuticals to the west, Masterlink Logistics and Geodis Logistic to the north, and Flood Recycling and The Tech Group to the east. To the south of the site leads to the M3/N3 national route and motorway.

All of these developments, including the Rottapharm Ltd. site, would have a cumulative impact on environmental media, such as air, noise, waste, water and waste water, material assets, flora and fauna, visual impact, roads, as well as groundwater & soil, and history and archaeology during their construction. It is considered that the cumulative impacts to the environment are generally negative, but not significant. The emissions from most of the surrounding facilities, including the Rottapharm facility are controlled under the EPA Industrial Emissions/Integrated Pollution Control licensing system; thereby controls are in place to ensure that environmental emissions in the area are acceptably low. As part of the air dispersion modelling carried out for the review application, it was determined, using EPA guidance Air Dispersion Modelling from Industrial Installations Guidance Note (AG4), that a cumulative impact study of air emissions was not required.

A cumulative impact that would be positive, for example, would be the generation of significant employment in the area and in the wider region, with both direct and indirect employment.

1.5 Indirect Impacts

The development has led to a number of indirect spin-off employment opportunities through local contractors, service providers and suppliers.

Off-site treatment and disposal of the wastes and wastewaters generated at the facility has a potential indirect impact on air, soil, surface water, and groundwater quality at the off-site treatment/disposal sites. However these activities are carried out by licensed operators and contractors and therefore are not expected to have a significant impact on the environment.

1.6 Conclusion

It is concluded that there are no significant cumulative or indirect impacts associated with the proposed development. It is concluded that the interaction of the impacts does not lead to significant impacts beyond those identified for each of the individual environmental media.

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IE0311736-LET-0002_1_01.DOCX

162.TP.15, Issue 7, 10/12/2015

Saudi Arabia

Singapore

Slovakia

Turkey

UK

USA

T

E

W



Belgium

China

Czech Republic

India

Ireland

Poland

Russia

+353 1 404 0700

[email protected]



PM Group

Killakee House

Belgard Square

Dublin 24

Ireland

Attachment 2 Air Dispersion Modelling Report for VOCs

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ARUP

Rottapharm Ltd

Industrial Emissions licence review

Air Dispersion Modelling Assessment of VOC

REP1

Issue1 | 18 April 2016

This report takes into account the particular instructions and requirements of our client.

It is not intended for and should not be relied upon by any third party and no responsibility is undertaken to any third party. Job number 248559-00

Ove Arup & Partners Ireland Ltd

Arup 50 Ringsend Road Dublin 4 D04 T6X0 Ireland www.arup.com

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Rottapharm Ltd Industrial Emissions licence reviewAir Dispersion Modelling Assessment of VOC

REP1 | Issue1 | 18 April 2016 | Arup

\\DUBNTS03\DUBLIN_JOBS\248000\248559-00\4. INTERNAL\4-03 DESIGN\4-03-02 CONSULTING\2016\ISSUE REPORT ON VOC EMISSIONS 18042016.DOCX

Contents Page

1 Introduction 1

2 Methodology 1

2.1 Air quality limit values 1

2.2 Modelling methodology 2

2.3 Cumulative impact 3

3 Impact assessment 4

3.1 Emissions from the Rottapharm facility 4

3.2 Cumulative emissions 5

4 Conclusions 6

5 References 6

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Page 1

1 Introduction

This study assesses the impact of VOC emissions from the Rottapharm facility on the atmospheric environment. Rottapharm is located in the Damastown Industrial Park, Dublin 15.

According to the Solvent Mass Balance Summary included in the 2014 Annual Environmental Report for the site, the main solvents used on site are IPA and Acetone.

Annual and 1-hour averages of ground level concentrations (GLCs) were calculated for the emissions.

Modelling results are compared to limits contained in the UKEA (UK Environment Agency) Integrated Pollution Prevention and Control (IPPC) Environmental Assessment and Appraisal of Best Available Technologies (BAT), Horizontal Guidance Note.

The potential cumulative impact of the Rottapharm facility and other nearby facilities is also considered.

2 Methodology

2.1 Air quality limit values

No air quality standards currently exist for IPA or Acetone in Ireland. The UKEA “IPPC Environmental Assessment and Appraisal of BAT, Horizontal Guidance Note”, sets out Environmental Assessment Levels (EALs) (both short term and long term) for a number of pollutants, including IPA and Acetone.

Short term (1 hour) and long-term (annual average) limit values established for IPA and Acetone are included in Table 1 below.

Table 1: Environmental Assessment Levels (EALs) from IPPC Horizontal Guidance Note

Pollutant Limit value for the protection of:

Averaging period Limit value (μg/m3)

IPA (Propan-2-ol) Human Health Short term EAL1

(1-hour Average)

125,000

Human Health Long term EAL (annual average)

9,990

1Unless otherwise stated, derived from Health & Safety Executive, EH40/2001, Occupational Exposure Limits 2001, 15 minute reference period converted to hourly mean.

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Page 2

Acetone

Human Health

Short term EAL1

(1-hour Average)

362,000

Human Health Long term EAL (annual average)

18,100

2.2 Modelling methodology

The air dispersion modelling assessment was completed in accordance with the Environmental Protection Agency (EPA) Guidance (Air Dispersion Modelling from Industrial Installations Guidance Note (AG4)). The guidance provides a recommended approach for all elements of air dispersion modelling.

The USEPA approved Breeze AERMOD Version 14134 computer programme was used to predict the effect of VOC emissions on ambient air quality. The model predicts GLCs of VOCs at receptors in the vicinity of the site. The pollutant concentrations are affected by a number of factors which include inter alia:

Emission data;

Meteorological data;

The proximity and elevation of the receptors;

The wake effect from buildings and other structures.

Air dispersion modelling was carried out to assess the impact of the emissions on ambient air quality in the vicinity of the site.

2.2.1 Emission data

Emission data and source characteristics were supplied by Rottapharm. Emission source data input into the model includes the temperature, efflux velocity, height of discharge and emission rate, as outlined in Table 2 below.

Table 2: Source emission data Parameter Value

Easting 305,364

Northing 241,365

Height above ground (m) 13

Diameter (m) 0.75

Volumetric flow rate (Nm³/hr) 18,900

Actual Velocity (m/s) 2.12

Temp (ºC) 40

VOC Emission Rate (g/s) 0.105

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Page 3

As IPA is 60% carbon and acetone is 62% carbon, predicted concentrations of VOCs are divided by 0.6 and 0.62 to determine the concentration of IPA and Acetone respectively.

2.2.2 Meteorological Data

Meteorological data recorded by Met Éireann at Dublin Airport was used over the period 2010 to 2014. The meteorological data includes hourly values of wind speed, wind direction, atmospheric stability, ambient temperature and mixing heights.

2.2.3 Receptors

Two uniform Cartesian receptor grids were used in the assessment. The first grid extends for at least 1 km in each direction from the facility, with receptors at 100 m intervals. The second grid extends for 5 km in each direction from the facility, with receptors at 1 km intervals.

Ground level concentrations are predicted at each receptor location. These receptors do not represent individual residences but would be representative of potential worst-case receptors. On-site receptors were excluded from the model.

Terrain elevations were supplied by the Ordnance Survey Ireland.

2.2.4 Building wake effect

Building data comprised the length, width and height of each section or tier. This data was compiled for each building. A software utility called BPIP was used, in conjunction with the location and height of emission sources, to calculate direction-specific building downwash factors from the building data. The dimensions, roof heights and location of the buildings were taken from site plans.

2.3 Cumulative impact

An assessment of the potential cumulative impact of emissions from the Rottapharm facility and other nearby licensed facilities was carried out in accordance with Appendix F – Cumulative Impact Assessments of the EPA guidance ‘Air Dispersion Modelling Guidance Note (AG4)’. This guidance only requires a detailed assessment when one of the following occurs (refer to Figure A2 of the guidance: Flowchart for undertaking a cumulative impact assessment of a nearby industrial installation (based on USEPA PSD approach)):

There is an installation within the ‘impact area’. This is defined as the area where the installation is predicted to exceed 5% of the air quality standard;

The nearby installation emits > 100 tonnes/annum;

The impact from the proposed installation is greater than 5% of the AQS; or

The impact of any nearby installation is greater than 5% of the AQS.

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Page 4

This modelling report focuses on emissions of VOCs, however CO and NOx are also emitted from the Thermal Oxidiser stack. On this basis, the cumulative assessment of CO and NOx are considered from the air dispersion modelling report carried out in 2010.

3 Impact assessment

3.1 Emissions from the Rottapharm facility

Predicted ground level concentrations of VOC from the Thermal Oxidiser are compared with the relevant limit values in Table 3. In order to assess a worst-case, it is assumed (a) that all emissions are IPA and (b) all emissions are Acetone.

Table 3: Predicted ground level concentrations and comparison with limit values

Pollutant

Environmental Assessment Levels (EALs) (μg/m³)

Highest Predicted Value (μg/m³)

Highest Predicted Value as Percent of EALs (%)

Location of Highest Predicted Value x, y (m)

IPA1

1-hour average

125,000 107.7 0.08 305490, 241325

Annual average

9,990 4.3 0.04 305490, 241325

Acetone2

1-hour average

362,000 104.2 0.03 305490, 241325

Annual average

18,100 4.1 0.02 305490, 241325

1 Predicted concentrations divided by 0.6 to determine concentration of IPA 2 Predicted concentrations divided by 0.62 to determine concentration of Acetone

The worst case maximum 1-hour concentration of IPA is predicted to be 107.7µg/m³; this is well within the short-term limit of 125,000μg/m³ for IPA. The worst case maximum 1-hour concentration of Acetone is predicted to be 104.2µg/m³; this is well within the short-term limit of 362,000 μg/m³ for Acetone.

The worst case maximum annual average concentration of IPA is predicted to be 4.3µg/m³; this is well within the long-term limit of 9,990μg/m³ for IPA. The worst case maximum annual average concentration of Acetone is predicted to be 4.1µg/m³; this is well within the long-term limit of 18,100μg/m³ for Acetone.

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Page 5

3.2 Cumulative emissions

As outlined in Section 2.3, a detailed assessment of cumulative impacts only needs to be completed when one of the criteria outlined in the flowchart is met. The relevant criteria are addressed individually below.

1. Is there a regulated nearby installation within the ‘impact area’.

In order to consider this criterion, the impact area for each relevant pollutant needs to be considered. The predicted worst-case maximum 1-hour and annual average VOC concentrations due to Rottapharm are less than 5% of the limit values for IPA and Acetone. On this basis, there is no ‘impact area’ relating to VOCs and no assessment is required.

The previous modelling assessment carried out to assess emissions of NO2 and CO from the Rottapharm facility (Arup, 2010) concluded that predicted CO concentrations did not exceed 5% of the air quality standard. On this basis, there is no ‘impact area’ relating to CO and no assessment is required. Predicted concentrations of NO2 exceeded 5% of the 99.79 percentile of 1 hour air quality standard within approximately 2km of the facility. Predicted concentrations of NO2 exceeded 5% of the annual air quality standard within approximately 250m of the facility. Therefore criterion 2 is triggered and the impact area is 2km from the facility.

2. Does nearby installation emit >100 tonnes/annum of any pollutant

A number of facilities licensed by the EPA are located within 2km of the Rottapharm plant. These facilities and the relevant licensed mass emissions of NOx from the plants are outlined in Table 4.

Table 4: NOx mass emissions from nearby industrial facilities

Facility NOx mass emissions (tonnes/annum)

Greater than 100 tonnes/annum?

Astellas 1.3 No

Clarochem 6.5 No

Barclays Chemicals Manufacturing Ltd

n/a No

Mallinckrodt Pharmaceuticals

19 No

Kepak 1.5 No

On the basis of the above, no adjacent facilities generate greater than 100 tonnes per annum of NOx.

Therefore, no detailed assessment of cumulative emissions is required and no further criteria require assessment.

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Page 6

4 Conclusions

The results of the modelling confirm that the maximum ground level concentrations are well within the short-term and long term EALs for IPA and Acetone. Therefore, no environmental impact due to VOC emissions is predicted.

No cumulative impact with nearby industrial installations is predicted.

5 References

1. Integrated Pollution Prevention and Control (IPPC), Environmental Assessment and Appraisal of BAT, Horizontal Guidance Note IPPC H1, U.K. Environment Agency 2003.

2. Air Dispersion Modelling Guidance Note (AG4), EPA, 2009.

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PM GROUP

IE0311736-LET-0002_1_01.DOCX

162.TP.15, Issue 7, 10/12/2015

Saudi Arabia

Singapore

Slovakia

Turkey

UK

USA

T

E

W



Belgium

China

Czech Republic

India

Ireland

Poland

Russia

+353 1 404 0700

[email protected]



PM Group

Killakee House

Belgard Square

Dublin 24

Ireland

Attachment 3 RTO Test Programme

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1

Approved By:

Peter O'Sullivan, EHS Advisor Prepared By:

[email protected] Email:

01-8852700/ 01-8852746 (Direct) Telephone:

Peter O Sullivan (EHS Advisor) Contact:

Rottapharm/Madaus Ltd, Damastown Industrial Park, (Damastown Town land), Mulhuddart, Dublin 15.

Site Address:

P0886-01 Licence Number:

Proposal for Air Abatement Test Programme Rev 2

A AaTTAPMRAM I <1JirADAUS Rottapharm Ltd. ._,.,

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2

19

16 18

11 12 13 14 15 15 15 15

10

6 7 8 9

4 4 5

3

Appendix A: Wright Environmental Services RT) Quarterly Testing 09/04/2010

Appendix B: Wright Environmental Services RT) Quarterly Testing 13/07/2010

Appendix C: Wright Environmental Services RT) Quarterly Testing 28/10/2010

Appendix D: Environmental Incident Report, EIR 10-02

Ongoing Emissions Monitoring 7.

Reference Conditions for Emissions to Air Table 10: Oxygen Concentration Correlation with Solvent Concentration

6.

Compliance with Emission Limits Table 3: Wright Environmental Services RTO Quarterly Testing 9/04/2010 Table 4:. Wright Envlronmental Services R'I'O'Qiiarterly Testing 13/07/2010 Table 5: Wright Environmental Services RTO Quarterly Testing 28/10/2010 Table 6: Maximum Inlet & Exhaust Temperature (during WES testing) Table 7: Minimum Inlet Pressure Reading (during WES testing) Table 8: Maximum LEL during Emissions Testing (during WES testing) Table 9: Combustion Temperature Readings (during WES testing)

5. Maintenance & Calibration 4.

Control & Management Figure 3: Best case and worst case calculation for by-pass events Table 1: Process Parameters Monitored as per IPPC Licence P0886-01 Table 2: Process Parameters & Reference Conditions

3.

Criteria for Operation Figure 1: Regenerative Thermal Oxidiser, Rottapharm Ltd. Figure 2: Operating Modes Durr Ecopure 3015

2. Introduction 1.

TABLE OF CONTENTS

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1 Integrated Pollution Prevention & Control Licence P0086-0l, Condition 6, p 14 2 Rottapharm Limited User Requirement Specifications URS 9/001, p 7 3 Integrated Pollution Prevention& Control Licence P0086-01, Schedule B (bl), p 24 4 Environment Protection Agency Office of Environmental Enforcement (OEE), Air Emissions Monitoring Guidance Note #2 (AG2)

The access to the emission point and stack testing company used during the abatement

test programme have been evaluated against 4Air Emissions Guidance Note #2 (AG2) as

well as relevant Source Testing Association (STA) of the UK safety standards.

• C (as TOC) equal or below 20 mg/Nm3

• CO equal or below 100 mg/Nm3

• NOx equal or below 100 mg/Nnr'

The RTO system is designed to ensure compliance of the following 3emission limits at

emission point A2-1:

This RTO system is a type Ecopure 3015 (Supplier: Durr Systems GmbH, Environmental

and Energy Systems) with a maximum air flow capacity of approx. 18900m3/h (as per

technical amendment request), with an exhaust air stack height of 13m and diameter

750mm to allow sufficient aeration of the exhaust gases above the existing surrounding

buildings of lOm height.

As per Rottapharm Limited IPPC Licence P0886-011, this document fulfils the

company's obligations under Condition 6.1 and is submitted to the Agency in

conjunction with sampling data and with reference to guidance documents to evaluate the

test programme for the on-site Regenerative Thermal Oxidiser (RTO). The RTO is a

purposed built oxidation device for combustion of hydrocarbons from a Rottapharm

Limited 2Pharmaceutical Spray Coating Process for Coating of Pellets in a 350L Coating

system with In and Exhaust air supply for pellet drying and no air recycling.

1.0 Introduction:

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5 Dilrr Operation Instructions: Description of Exhaust Air Purification, Chapter 3, pg 4

The RTO system is heated by a natural gas burner system. The system is designed for a

high thermal efficiency to reduce the energy consumption of the burner to a minimum.

Following an initial RTO heating cycle, the solvent loading in the air produces excess

heat in the exothermal oxidation, allowing the RTO to operate on an auto thermal basis

without the requirement for supplementary gas for the majority of time. Three LEL

The exhaust air emitted from each of the coating pans during the pharmaceutical

production processes (namely the Tromalyt, Fortilase and Extranase processes) is

directed via three discrete exhaust air fans to the RTO system. Once within the RTO

system, the exhaust is directed to zones of hot ceramic heat exchanger media which

oxidises and cleans the exhaust air to within specified limits (as referenced above)

Arrangement of Ecopure-RTO System:

2.0 Criteria for Operation: Figure 1: Regenerative Thermal Oxidiser Rottapharm Ltd 5

4

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6 Functional Sequence Description: Thermal Exhaust Purification "[RTO 3015Typ], p 6

Process air mode ___,

Fresh air mode

Heat-up

Prepurge

RTO quick cooling Shutdown step

Fault shutdown Emergency shutdown

Figure 2: Operating Modes Dilrr Ecopure 30156

There is also an alternative process exhaust in place for venting of the process exhaust

gases to the atmosphere during operation of the coating equipment in "non VOC mode"

(i.e. during water based coating applications) and as an emergency venting for the case of

a shutdown fault at the RTO.

The two solvents being oxidised in the RTO are acetone and isopropyl alcohol. They are

present in the approximate ratio of 40% acetone and 60% isopropyl alcohol in the coating

process. The concentration of the solvent is continuously monitored and maintained

below 25% of the lower explosive limit for safety critical purposes before the RTO inlet.

The RTO System includes a system for heat recovery from exhaust air, wherein the site

medium pressure hot water loop is heated.

monitoring devices in the supply ensure that the maximum allowed inlet concentration

for will not be exceeded. The inlet air concentrations are limited to a set point of 15% of

the LEL of the exhaust gas (IPA) with alarms above 25% of the solvent.

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Figure 3 shows the calculation for "best case') and "worst case" solvent emission for the

by-pass event that occurred on the 28/10/2010, where the abatement system was by

passed. This calculation does not take into account the adsorption by the tablets of

solvents and presumes that emission is based on input of coating material by some factor

of time or spray rate.

3.0 Control & Management:

A visible and audible alarm beacon is located at the RTO and in Manufacturing Area 2 at

the location of the main and remote controller of the unit. This alarm indicates the status

of the RTO. The alarm indication enables a timely response to an RTO fault

Warning or error/alarm messages that occur during RTO operations are logged by the

operators in the dedicated RTO Logbook located in Room M15 in Production Area 2.

These messages are reported immediately to the engineer or technician on duty by

production personnel and an investigation is initiated. Occurrences of alarms are recorded

in the logbook.

In the event of an RTO warning alarm the beacon located in Production Area 2 will

indicate by flashing red.

Shutdown alarm messages will immediately initiate a By-Pass event resulting in the loss

of the air treatment function of the RTO. Emissions from the operational process will be

automatically directed to atmosphere without treatment. The alarm sounder will ring and

the beacon will indicate steady red.

In the case of the occurrence of a By-Pass Event the Production Manager and EHS

Department are notified. Recording of best case and worst case solvent release are

recorded on the Batch Manufacturing Record (BMR) via a simple calculation.

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7

• Emergency isolation of the RTO, should a high inlet LEL occur.

• Inlet LEL control comprising of three LEL sensors and fresh air damper

The following additional equipment safety controls are included on the RTO:

In line with the production SOP, a new production process sequence cannot commence

until the full RTO operating function (Production Area 2 Beacon with Green Light) has

been restored.

51.63609 k voe total 72.75994 62 mins 44 mins

1.173547 1.173547 2.8 2.8

71.94639 71.505 171.6589 170.6058

163 162

Process tlme

Volume at time of alarm

Acetone Eth I Cellulose Triacetin 0.332 0.332 IPA 45.6 45.6 Kollidon VA64 1.437 1.437 ASA 105 105 Total 189.562 kg 189.562 kg Volume 180 L 180 L % solvents 41.91241 % 41.91241 %

Figure 3: Best case and worst case calculation for by-pass events

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7 Integrated Pollution Prevention & Control Licence P0086-01, Schedule C (c.1.1), p 25

Process Parameter Instrument Type Equipment Ta2 Number Inlet Temperature Thermocouple, Data KA163-T05

logger Inlet Pressure Pressure monitor, Data VP111-P02

logger Inlet Airflow Flow Monitor on C0-203-FIC-110

Equipment PLC C0-204-FIC-110 BP2-C0-201

Inlet Concentration of Flammable LEL Sensors, Datalogger KA163 Q04, Q14, Q24 Gas Combustion Temperature Thermocouples, BK126 TOS, T15, T25

Datalozzer Pressure drop across ceramic bed Pressure Indicator AP191 P02 Exhaust Air temperature Thermocouple, AT192 TOS

Datalogger Exhaust Air flow Flow Monitor on C0-203-FIC-110

Equipment PLC C0-204-FIC-110 BP-C0-201

Table 1: Process Parameters Monitored as per IPPC Licence P0886-0I 7

Table 1 & Table 2 set out the precise conditions that are required for the oxidation of the

hydrocarbons in the process stream and monitored continuously in line with Rottapharm

Ltd IPPC Licence.

• RTO inlet air pressure monitoring and control to ensure constant negative

pressure in the RTO main duct, extracting all exhaust gases of the process

equipment.

• Three combustion chamber temperature monitoring devices to assure meeting

of the minimum combustion temperature at all times in all areas of the

combustion chamber

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Process Parameter Desizn Limits Euuiument Tai! Number Inlet Temperature 75°C (W) 85°C (A) KA163-T05 Inlet Pressure -15mbar(W)-20mbar(A) VP111-P02 Inlet Airflow 6000 m3/hr FIC-110-C0-203

FIC-11 O-C0-204

Inlet Concentration of Flammable 22% (W) 25% (A) KA163 Q04*, Ql4, Q24 Gas Combustion Temperature 990 (W) 1040 (A) BK126 T05, T15, T25 Pressure drop across ceramic bed 1.0 mbar (A) AP191 P02 Exhaust Air temperature 260 (W) 280(A) AT192 TOS Exhaust Air flow 6000 m3/hr FIC-110-C0-203

FIC-110-C0-204

Pump Speed 55Hz VV141 MPHW Temperature 110 (W) 115(A) WT128 T05, T25

Table 2: Process Parameters & Reference Conditions

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8 Exhaust Air Purification: Ecopure RTO 315, Maintenance Manual SR-MMOO

The RTO system is fully integrated into the Rottapharm Ltd. preventative maintenance

system. All critical functions, system devices and instruments are routinely inspected and

tested (weekly, 4 weekly, 24 weekly and 48 weekly intervals) in order to ensure high

system availability and safety. Critical safety functions/instruments such as the LEL

sensors are calibrated bi-annually by specialist external contractor. Maintenance Manual

SR-MM0088

4.0 Maintenance & Calibration:

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• Spray/Drying ( achieved by comparison of stack results at A2-1 against internal

manufacturing data)

• Variations in the ratio of solvents (achieved via alternation of coating pans within

the manufacturing process)

• Maximum throughput examination of solvent (achieved by using worst case

scenario for throughput of solvents against monitoring of A2-1)

• Start up examination (achieved by monitoring of initial stages of the operation of

the RTO via examination of A2-1)

• Shut down (achieved by monitoring of the shutdown sequence of the RTO via

monitoring of A2-1)

As per Table 2, the company will monitor the process parameters & reference conditions

while the independent stack testing company will monitor combustion gases, flow rate,

Oxygen Percentage and Temperature from the process thus enabling matching of data to

ensure abatement of VOC s. Certain conditions will be examined during the testing which

will include:

5.0 Compliance with Emission Limits:

The air abatement test programme forthe RTO will be governed by the fact that the

operation is a straightforward batch manufacturing process in which solvent is used in

coating of Tromalyt. This process requires a sequence of spray/drying of a mixture which

contains approximately 60% Isopropyl Alcohol and 40% Acetone. The company

purposes a number of monitoring campaigns by a licensed contractor to evaluate the

abatement capabilities of the RTO. These campaigns will typically involve continuous

and non-continuous methods.

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9 Wright Environmental Services (Quarterly Emission Monitoring Report RottaphannLtd), Report No. 1088, p 5

Appendix A gives a more detailed analysis of the parameters during the monitoring

campaign.

Note: Concentration of emissions (mg/Nm3) were calculated and reported as per Licence reference conditions, temperature 273°K, pressurelOJ.3 kPa, dry gas and corrected to 18% Oxygen

Pnrameter/Tlme 19.27 - 19.57 19.57 - 20.27 20.31 - 21.01 Temperature (°C) 69 63 106

Oxygen% (Dry gas) 19.8 19.7 19.7

Thermal Oxidiser Emissions - Flue Gas Conditions

Parumeter/Tlmc 19.27 - 19.57 19.57 - 20.27 20.31 - 21.0l

Total organic carbon (C) 19.4 16.6 17.3

Nitrogen Oxides (as N02) Less than 2 Less than 2 Less than 2 Carbon Monoxide (CO) 9 9 9

Thermal Oxldlscr Emissions - Conceutratlon mg/Nnt3

Corrected to Dry Gas and 18% Oxygen

Table 3: Wright Environmental Services (WES), RTO Quarterly Testing 9/04/20109•

Throughout commissioning phase, testing and analysis has been completed on a quarterly

basis, as per IPPC Licence P0886~01. While not challenging the RTO like the above test

programme will, there has been a high level of success regarding the functioning of the

abatement equipment. This can be seen from the below tables of results which show

results from stack testing for the last three quarterly tests. Included also, is the results

from Rottapharm internal monitoring ofRTO system on these test dates as stipulated as

part of the licence requirements in Table 2 above.

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10 Wright Environmental Services (Quarterly Emissions Monitoring Report Rottapharm Ltd), Report No. 1112, p5

Appendix B gives a more detailed analysis of the parameters during the monitoring

campaign.


Parameter/Time 9.48-10.18 10.18 - 10.48 10.48 - 11.18 Temperature (°C) 52-64 54-496 80-498

Gas Flow Rate (Nni3 /h) 5747 8332 8363 Gas Flow Rate (Nni3 /h)

Dry and 18% Oxygen 724 3515 3733

Oxygen% (Dry gas) 20.5 19.6 19.6


Paramerer/Thue 9.48 -10.18 10.18 -10.48 10.48- 11.18 Total organic carbon (C) 2.2 12.1 14.6

Nitrogen Oxides (as N02) Less than 8 Less than 2 Less than2 Carbon Monoxide (CO) Less than 8 70 52

Thermal Oxidiser Emissions - Concentration mg!Nni3


Table 4: Wright Environmental Services (WES), RTO Quarterly Testing 13/07/201010

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11 Wright Environmental Services (Quarterly Emissions Monitoring Report Rottapharm Ltd), Report No. 1113, p5

Appendix C gives more detailed analysis of each parameter during the entire monitoring

campaign. The testing data in Table 3 above shows non compliance with the Carbon

Monoxide limits set out in the Licence. Upon receipt of the external stack testing

company's report, a full internal investigation was launched into the exceedence. The

results of this investigation are shown in Appendix D

Note: Concentration of emissions (mg/Nm3) were calculated and reported as per Licence reference conditions, temperature 273°1(, pressurelOJ.3 kPa, dry gas and corrected to 18% Oxygen

I 10.24 - 10.54 10.59 - 11.29 11.32-12.02 Parameter/Time Spray/Dry Spray/Dry Spray/Dry

Temperature (0C) 53 - 499 45 - 478 47 -442

Gas Flow Rate (Nm3/h) 8961 9947 10294

Gas Flow Rate (Nn/ /h)

D1y and 18% Oxygen 4503 3725 4475

Oxygen % (Dry gas) 19.4 19.8 19.6

Thermal Oxidiser Emissions (A2-1)- Flue Gas Conditions

Parameter/Thue 10.24- I0.54 10.59 - 11.29 11.32 - 12.02 Su ray/Dry Spray/On· Sn ray/Dry


Nitrogen Oxides (as N02) 25 12 4 Carbon Monoxide (CO) 895 140 29

Thermal Oxidiser Emissions - Concentration ing/Nn.3


Table 5: Wright Environmental Services (WES), RTO Quarterly Testing 28/10/201011

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Date Min Combustion Max Combustion Temperature Temperature

9t1i April 2010 920°C 920°C 13tn July 2010 860°C 940°C

28th October 2010 820°C 970°C Design 780°C 1040 °C (990 °C*)

Table 9: Combustion Temperature Readings (during WES testing)

Date Max LEL Reading Max LEL Reading Max LEL Reading Q04 Q14 Q24

9m April 2010 17% 11% 11% 13th July2010 23% 12% 11%

28th October 2010 30% 14% 13% Max Design NIA 25% 25%

Table 8: Maximum LEL during Emissions Testing (during WES testing)

Date Pressure 9m April 2010 -5.5 bar 13tn July 2010 -9 bar

28m October 2010 -9.5 bar Desian - 20 bar (-15 bar)

Table 7: Minimum Inlet Pressure Reading (during WES testing)

Date Max Inlet Temperature Max Exhaust Temperature 9th April 2010 18 66 13tn July 2010 25 73

28m October 2010 15 65 Desizn 85 280

Table 6: Maximum Inlet & Exhaust Temperature (during WES testing)

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Justification for Purposed Change:

Fuel Efficiency

When a fuel is burned, oxygen in the air is consumed. The oxygen concentration in the

flue gas depends on how much fuel is burned, The more fuel burned the lower the 02

concentration and hence the lower the correction factor. Conversely the less fuel burned

the higher the 02 concentration and hence the higher the correction factor.

The RTO at Rottapharm operates very efficiently with a high degree of heat recovery.

This means that less supplementary fuel is needed to maintain the temperature in the

combustion chamber. With higher solvent concentrations, no supplementary fuel is

required.

The RTO emissions to air were measured during commissioning testing in April 2010.

Over the 3 half hours tests taken, the oxygen concentration was 19.8%, 19.7% and 19.7%

respectively. These high oxygen concentrations are achieved by burning less fuel and not

by the addition of dilution air to the flue gas emission. In this situation the oxygen

correction factor would be 2.4 for 19.7% oxygen.

Following completion of analysis and testing during the commissioning phase of this

equipment, Rottapharm purposes a change to the reference conditions to the following:

"Temperature 273K, Pressure 101.3 kPa (no correction for oxygen and water content)."

Temperature 273K, Pressure 101.3 kPa, dry gas; 18% oxygen (or as otherwise agreed by

the Agency following the completion of a test programme). "

In the case of the thermal oxidiser: "4.2.3

6.0 Reference Conditions for Emissions to Air:

Condition 4.2.3 of our IPPC licence presents reference conditions for the emissions to

atmosphere from the RTO as follows:

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The two solvents being oxidised in the RTO are acetone and isopropyl alcohol. They are

present.in the ratio of 40% acetone and 60% IP A. This would result in a maximum

solvent concentration of 12g/m3 of combined solvent in the feed to the RTO. We have

calculated that the resultant oxygen concentration in the flue gas after complete

combustion of this solvent will be 18.9%. In this situation the oxygen correction factor

would be 1.45.

We have calculated the resultant oxygen concentration in the flue gas based on the

following:

When a solvent is oxidised, oxygen combines with the carbon and hydrogen in the

solvent in a definite ratio. The amount of oxygen used up will depend on the quantity of

solvent being oxidised. Therefore, on complete oxidation of the solvent, the amount of

oxygen used up can be calculated.

Complete Solvent Combustion


Parameter/Tlme 19.27 -19.57 19.57 - 20.27 20.31 - 21.01

Temperature (°C) 69 63 106

Oxygen% (Dry gas) 19.8 19.7 19.7


Parnmeter/Tltue 19.27 - 19.57 19.57 - 20.27 20.31-21.01


Nitrogen Oxides (as N02) Less than 2 Less than 2 Less than 2

Carbon Monoxide (CO) 9 9 9

Thermal Oxidiser Emissions - Concentration mg/Nm3

Corrected to D1·y Gas nncl 18% Oxygen

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Temperature 273K, Pressure 101.3 kPa (no correction for oxygen and water content)."

In the case of the thermal oxidiser: "4.2.3

On the basis of this justification, it is proposed that the 18% oxygen is inappropriate in

this situation and Rottapharm Limited would like propose that the emission to air be

corrected to the following reference conditions.

Solvent Concentration in Resultant 02 % in Corresponding 02 Feed to the RTO g/m3 flue gas correction factor

12 (25% of 18.92 1.5 LEL)

6 19.86 2.8

3 20.33 5.1

1.5 20.57 8.7

Table 10: Oxygen Concentration Correlation with Solvent Concentration

As discussed above the amount of oxygen used up in the oxidisation process is dependent

on the quantity of solvent being oxidised. When the concentrations of solvent being

supplied to the RTO is reduced further below 25% of the LEL, less oxygen would be

consumed in the oxidation process and therefore the oxygen concentrations would

increase above 18.9% in the flue gas resulting in a higher (greater than 1.45) oxygen

correction factor. The table below demonstrates how the oxygen concentration in the flue

gas and corresponding correction factor depend on the solvent concentration in the feed

to theRTO.

Reduction in the Solvent available for combustion

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This monitoring data will be submitted to the Agency in the Annual Environmental

Report. In addition, all by-pass events will be communicated in this annual report.

• No correction for moisture or oxygen

• Temperature 273°K

• Pressure 101.3kPa

Oxygen, Carbon Monoxide and Nitrogen Oxides - This will be measured using a Kane

May flue gas analyser or equivalent. Electro chemical cells are present in this instrument

to measure each compound.

Gas Flow Rate and Temperature - Gas velocity will be measured using a Pitot or

Prandtl type tube or equivalent and a differential pressure manometer. Gas flow rates will

be measured from the velocity and the cross sectional area of the stack at the sampling

point. Temperature will be measured using a thermocouple or equivalent.

The measurement reference conditions in order to calculate the concentration of

emissions in mg/Nm3 are as follows:

Total Organic Compounds (TOC as C) - This will be determined using a direct

reading instrument such as a Bernath Atomic Portable Flame Ionising Detector Model

No. 3006 or equivalent. The instrument will be calibrated against a known standard

concentration of propane, prior to use.

7.0 Ongoing Emission Monitoring:

Rottaphann's IPPC Licence stipulates quarterly monitoring of the RTO air emissions.

It is proposed that emissions monitoring is completed on site by an approved contractor,

selected by Rottapharm Ltd. on an annual basis. This monitoring will occur as per the

IPPC licence on a quarterly basis.

Testing will be performed during normal operating conditions when the RTO, as defined

by usage requirements of the parallel coaters.

The following sampling and analytical methods are proposed for each measurement

parameter:

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Time Temperature Oxygen co NOx

oc % mg!Nmj mg/Nmj

19:32:30 85 19.7 3.4 0.4 19:32:45 19.7 3.8 0.5 19:33:00 110 19.7 3.1 0.4 19;33:15 19.7 2.6 0.4 19:33:30 117 19.7 3.2 0.4 19:33:45 19.8 3.6 0.4 19:34:00 78 19.8 3.5 0.3 19:34:15 19.8 3.2 0.3 19:34:30 74 19.8 3.1 0.3 19:34:45 19.8 3.3 0.4 19:35:00 63 19.8 3.5 0.4 19:35:15 19.8 3.3 0.4 19:35:30 65 19.8 3.3 0.4 19:35:45 19.8 3.2 0.4 19:36:00 103 19.8 3.3 0.4 19:36:15 19.7 3.7 0.4 19:36:30 103 19.7 3.5 0.4 19:36:45 19.7 3.5 0.4 19:37:00 71 19.7 3.4 0.4 19:37:15 19.7 3.5 0.6 19:37:30 71 19.7 3.4 0.4 19:37:45 19.7 3.3 0.4 19:38:00 72 19.7 3.2 0.4 19:38:15 19.7 3.2 0.4 19:38:30 62 19.7 3.5 0.4 19:38:45 19.8 3.5 0.5 19:39:00 65 19.8 3.3 0.6 19:39:15 19.8 3.1 0.4 19:39:30 103 19.8 3.5 0.4 19:39:45 19.8 3.8 0.4 19:40:00 89 19.8 3.3 0.4 19:40:15 19.7 3.0 0.5 19:40:30 69 19.7 3.3 0.4 19:40:45 19.7 3.$ 0.4 19:41:00 71 19.7 3.4 0.4 19:41:15 19.7 3.2 0.4 19:41 :30 74 19.7 3.1 0.4

TO Emissions - No Correction for Moisture or Oxygen

Appendix A

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19:41:45 19.7 3.3 0.5 19:42:00 62 19.7 3.6 0.6 19:42:15 19.7 3.5 0.4 19:42:30 65 19.7 3.2 0.4 19:42:45 19.7 3.2 0.4 19:43:00 67 19.7 3.2 0.4 19:43:15 19.7 3.4 0.4 19:43:30 63 19.7 3.4 0.4 19:43:45 19.7 3.3 0.4 19:44:00 67 19.8 3.1 0.5 19:44:15 19.8 3.0 0.4 19:44:30 67 19.8 3.4 0.6 19:44:45 19.8 3.1 0.5 19:45:00 68 19.8 2.9 0.4 19:45:15 19.7 3.0 0.4 19:45:30 73 19.7 3.0 0.4 19:45:45 19.7 3.3 0.4 19:46:00 61 19.7 3.3 0.4 19:46:15 19.7 3.0 0.4 19:46:30 62 19.7 2.8 0.4 19:46:45 19.7 3.0 0.4 19:47:00 65 19.7 3.6 0.4 19:47:15 19.7 3.7 0.4 19:47:30 64 19.7 3.4 0.4 19:47:45 19.7 3.2 0.4 19:48:00 68 19.8 3.4 0.4 19:48:15 19.8 3.5 0.4 19:48:30 65 19.8 3.4 0.4 19:48:45 19.8 3.1 0.4 19:49:00 70 19.7 3.0 0.4 19:49:15 19.7 2.9 0.4 19:49:30 74 19.8 3.3 0.4 19:49:45 19.8 3.4 0.4 19:50:00 61 19.8 3.3 0.4 19:50:15 19.7 3.1 0.4 19:50:30 63 19.7 3.1 0.4 19:50:45 19.7 3.4 0.4 19:51:00 61 19.7 3.6 0.4 19:51:15 19.7 3.6 0.4 19:51:30 64 19.7 3.4 0.4 19:51:45 19.7 3.3 0.4 19:52:00 68 19.8 3.3 0.5

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19:52:15 19.8 3.2 0.4 19:52:30 58 19.8 3.2 0.4 19:52:45 62 19.8 3.2 0.4 19:53:00 19.7 3.0 0.4 19:53:15 60 19.8 3.3 0.4 19:53:30 19.8 3.8 0.4 19:53:45 64 19.8 3.5 0.4 19:54:00 19.8 3.2 0.4 19:54:15 63 19.7 3.0 0.4 19:54:30 19.7 3.3 0.4 19:54:45 66 19.7 3.6 0.4 19:55:00 19.7 3.4 0.4 19:55:15 71 19.7 3.1 0.4 19:55:30 19.7 3.1 0.4 19:55:45 59 19.7 3.5 0.4 19:56:00 19.8 3.8 0.4 19:56:15 61 19.8 3.6 0.4 19:56:30 19.8 3.3 0.4 19:56:45 60 19.7 2.9 0.4 19:57:00 19.7 3.1 0.4 19:57:15 61 19.8 3.5 0.4 19:57:30 19.8 3.4 0.4 19:57:45 65 19.7 3.3 0.4 19:58:00 19.7 3.1 0.4 19:58:15 62 19.7 3.3 0.4 19:58:30 19.7 3.6 0.4 19:58:45 67 19.7 3.5 0.4 19:59:00 19.7 3.4 0.4 19:59:15 65 19.7 3.4 0.5 19:59:30 19.7 3.8 0.5 19:59:45 59 19.8 4.0 0.4 20:00:00 19.8 3.6 0.4 20:00:15 63 19.8 3.4 0.4 20:00:30 19.8 3.4 0.4 20:00:45 61 19.8 3.2 0.4 20:01:00 19.8 3.6 0.4 20:01:15 64 19.8 3.6 0.4 20:01:30 19.7 3.~ 0.4 20:01:45 66 19.7 3.0 0.4 20:02:00 19.7 3.2 0.5 20:02:15 62 19.7 3.5 0.4 Averaze 69 19.8 3.3 0.4

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Time Temperature Oxygen co NOx oc % mg/Nm'\ mg/Nm3

20:02:30 67 19.7 3.5 0.3 20:02:45 19.7 3.5 0.3 20:03:00 65 19.7 3.5 0.4 20:03:15 19.7 3.7 0.4 20:03:30 69 19.7 3.6 0.4 20:03:45 19.7 3.3 0.4 20:04:00 59 19.7 3.3 0.4 20:04:15 19.7 3.1 0.4 20:04:30 61 19.7 3.0 0.4 20:04:45 19.7 3.0 0.4 20:05:00 62 19.7 3.2 0.4 20:05:15 19.7 3.3 0.4 20:05:30 64 19.7 3.3 0.4 20:05:45 19.7 3.3 0.4 20:06:00 63 19.7 3.8 0.4 20:06:15 19.7 3.9 0.4 20:06:30 66 19.7 3.5 0.4 20:06:45 19.7 3.4 0.4 20:07:00 64 19.7 3.5 0.4 20:07:15 19.7 3.5 0.4 20:07:30 67 19.7 3.6 0.3 20:07:45 19.7 3.3 0.4 20:08:00 71 19.7 3.2 0.4 20:08:15 19.7 3.2 0.4 20:08:30 59 19.7 3.5 0.4 20:08:45 19.7 3.6 0.4 20:09:00 61 19.7 3.6 0.4 20:09:15 19.7 3.5 0.4 20:09:30 59 19.7 3.3 0.4 20:09:45 19.7 3.4 0.4 20:10:00 61 19.7 3.6 0.4 20:10:15 19.7 3.5 0.4 20:10:30 65 19.7 3.5 0.6 20:10:45 19.7 3.4 0.5 20:11:00 62 19.7 3.6 0.4 20:11:15 19.7 3.8 0.4 20:11:30 66 19.7 3.5 0.4

TO Emissions - No Correctlou for Moisture or Oxygen

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20:11:45 19.7 3.1 0.4 20:12:00 59 19.7 3.0 0.4 20:12:15 19.7 3.3 0.4

20:12:30 57 19.7 3.7 0.4 20:12:45 19.7 3.7 0.4 20:13:00 61 19.7 3.5 0.4 20:13:15 19.7 3.2 0.4 20:13:30 58 19.7 3.1 0.4 20:13:45 19.7 3.7 0.4 20:14:00 61 19.7 3.7 0.4 20:14:15 19.7 3.1 0.5 20:14:30 61 19.7 3.3 0.4 20:14:45 19.7 3.5 0.4 20:15:00 62 19.7 3.7 0.4 20:15:15 19.7 3.9 0.4 20:15:30 68 19.7 3.7 0.4 20:15:45 19.7 3.3 0.4 20:16:00 57 19.7 3.1 0.4 20:16:15 19.7 3.2 0.4 20:16:30 59 19.7 3.4 0.4 20:16:45 19.7 3.3 0.4 20:17:00 62 19.7 3.3 0.4 20:17:15 19.7 3.4 0.4 20:17:30 60 19.7 3.5 0.4 20:17:45 19.7 3.5 0.4 20:18:00 64 19.7 3.4 0.4 20:18:15 19.7 3.4 0.4 20:18:30 61 19.7 3.5 0.4 20:18:45 19.7 3.5 0.4 20:19:00 65 19.7 3.2 0.4 20:19:15 19.7 2.9 0.4 20:19:30 69 19.7 2.9 0.4

20:19:45 19.7 3.0 0.4 20:20:00 58 19.7 3.4 0.4 20:20:15 19.7 3.7 0.4 20:20:30 60 19.7 3.5 0.4 20:20:45 19.7 3.4 0.4 20:21:00 59 19.7 3.3 0.6 20:21:15 19.7 3.5 0.6 20:21:30 62 19.7 3.6 0.4 20:21:45 19.7 3.5 0.4 20:22:00 66 19.7 3.5 0.4

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20:22:15 19.7 3.5 0.4 20:22:30 63 19.7 3.9 0.4 20:22:45 67 19.7 3.9 0.4 20:23:00 19.7 3.6 0.4 20:23:15 59 19.7 3.2 0.4 20:23:30 19.7 3.0 0.4 20:23:45 60 J9.7 3.3 0.4 20:24:00 19.7 3.6 0.4 20:24:15 63 19.7 3.6 0.4 20:24:30 19.7 3.5 0.4 20:24:45 60 19.7 3.4 0.4 20:25:00 19.7 3.5 0.4 20:25:15 64 19.7 3.7 0.4 20:25:30 19.7 3.5 0.4 20:25:45 61 19.7 3.2 0.4 20:26:00 19.7 3.2 0.4 20:26:15 64 19.7 3.4 0.4 20:26:30 19.7 3.5 0.4 20:26:45 68 19.7 3.3 0.4 20:27:00 19.7 3.1 0.5 20:27:15 58 19.7 3.1 0.4 20:27:30 19.7 3.2 0.4 20:27:45 59 19.7 3.2 0.4 20:28:00 19.7 3.5 0.4 20:28:15 58 19.7 3.1 0.4 20:28:30 19.7 3.2 0.4 20:28:45 59 19.7 3.7 0.4 20:29:00 19.7 3.9 0.4 20:29:15 58 19.7 3.7 0.4 20:29:30 19.7 3.6 0.4 20:29:45 59 19.7 3.5 0.4 20:30:00 19.7 3.7 0.4 20:30:15 63 19.7 3.9 0.4 20:30:30 19.7 3.8 0.4 20:30:45 58 19.7 3.5 0.4 20:31:00 19.7 3.2 0.4 20:31:15 62 19.7 3.5 0.4 20:31:30 19.7 3.6 0.4 20:31:45 93 19.7 3.5 0.4 20:32:00 19.7 3.1 0.4 20:32:15 63 19.7 3.1 0.3 Average 63 19.7 3.4 0,4

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Time Temp era ture Oxygen co NOx

oc % mg/Nm3 mg/Nm3

09:49 57 20.4 0 2 09:50 57 20.4 1 0 09:51 55 20.7 1 0 09:52 63 20.7 1 1 09:53 59 20.6 0 3 09:54 59 20.6 1 0 09:55 56 20.6 1 0 09:56 62 20.7 1 0 09:57 60 20.7 1 0 09:58 61 20.7 1 0 09:59 57 20.6 3 2 10:00 54 20.6 1 0 10:01 62 20.6 1 0 10:02 63 20.6 1 0 10:03 59 20.6 1 2 10:04 56 20.3 1 0 10:05 56 20.5 1 0 10:06 64 20.6 l 0 10:07 61 20.6 1 1 10;08 57 20.4 1 3 10:09 57 20.1 1 0 10:10 58 20.5 1 0 10:11 63 20.6 1 0 10:12 56 20.5 0 2 10:13 52 20.5 1 5 10:14 56 20.5 0 3 10:15 63 20.0 0 0 10:16 57 20.5 0 0 10:17 55 20.6 1 0 10:18 57 20.6 1 4

Average 58 20.5 0.9 0.9


AppendixB

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Time Temperature Oxygen CO, NOx

oc % mg/Nm3 m0/Nm3 " 10:19 54 20.6 0 0 10:20 59 20.0 0 0 10:21 58 19.3 1 0 10:22 64 19.4 2 0 10:23 59 19.5 2 0 10:24 59 19.5 1 0 10:25 65 19.9 1 0 10:26 69 20.1 1 0 10:27 67 20.l 2 0 10:28 66 20.1 2 0 10:29 67 19.4 0 0 10:30 101 19.4 2 0 10:31 160 19.3 2 0 10:32 124 19.2 3 0 10:33 434 19.2 23 0 10:34 353 19.4 68 3 10:35 477 19.4 15 0 10:36 463 19.5 17 0 10:37 473 19.8 70 0 10:38 344 19.8 78 0 10:39 496 19.6 50 0 10:40 479 19.6 54 0 10:41 471 19.6 74 0 10:42 471 19.6 46 0 10:43 411 19.7 63 0 10:44 482 19.7 71 0 10:45 488 19.7 86 0 10:46 486 19.7 25 0 10:47 483 19.6 71 0 10:48 484 19.7 78 0

Average 279 19.6 30 0.1


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oc o/o W!7/NJll3 mg/Nm3 ~

10:49 481 19.7 86 0 10:50 498 19.7 19 0 10:51 474 19.7 37 0 10:52 479 19.7 72 0 10:53 470 19.7 78 0 10:54 498 19.7 23 0 10:55 469 19.7 10 0 10:56 481 19.7 69 0 10:57 202 19.7 74 0 10:58 492 19.6 13 0 10:59 460 19.6 3 0 11:00 472 19.6 50 0 11:01 200 19.6 48 0 11:02 200 19.6 10 0 11:03 460 19.5 1 0 11:04 471 19.5 31 0 11:05 205 19.5 19 0 11:06 118 19.5 3 0 11:07 362 19.5 0 0 11:08 450 19.5 3 0 11:09 272 19.5 1 0 11 :10 121 19.5 1 0 11:11 116 19.5 0 0 11:12 291 19.5 0 0 11:13 304 19.5 0 0 11:14 219 19.5 0 0 11:15 412 19.5 3 0 11:16 159 19.5 13 0 11:17 214 19.5 0 0 11:18 80 19.5 0 0

Average 338 19.6 22 0

TO Emissions -No Correcttou for Moisture or Oxygen

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Time Temperature Oxygen co NOx oc % mg/Nm~ mo/Nm~ e,

10:25 53 19.3 0 2 10:26 57 18.6 1 1 10:27 372 18.8 4 4 10:28 435 18.3 654 5 10:29 434 17.8 2481 13 10:30 450 18.5 1949 17 10:31 466 19.6 752 5 10:32 441 19.4 479 5 10:33 449 19.3 825 9 10:34 466 19.4 919 13 10:35 465 19.5 817 13 10:36 478 19.4 664 11 10:37 465 19.6 332 9 10:38 461 19.7 448 13 10:39 463 19.8 345 15 10:40 487 19.7 273 16 10:41 474 19.8 114 9 10:42 464 19.9 197 18 10:43 469 19.8 182 17 10:44 384 19.7 182 19 10:45 487 19.6 192 20 10:46 476 19.6 202 21 10:47 470 19.7 189 18 10:48 260 19.7 175 17 10:49 480 19.6 184 19 10:50 499 19.7 168 11 10:51 470 19.7 92 10 10:52 464 19.6 172 21 10:53 443 20.0 176 17

Averaae 424 19.4 454 13


Appendix C

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oc % mg/Nm" mg/NmJ -

10:59 459 20.0 21 2

11 :00 361 20.0 26 3 11:01 402 20.0 39 6 11:02 478 20.0 132 7 11:03 456 20.0 85 6 11:04 452 19.9 117 9 11:05 456 19.9 111 7 11 :06 465 19.7 90 6

11:07 461 19.7 97 8 11:08 459 19.8 104 9 11:09 439 19.7 87 6

11:10 442 19.8 77 7 11:11 445 19.8 95 6 11:12 468 19.6 85 5 11:13 433 19.4 81 6 11:14 439 19.4 73 5 11:15 449 19.4 51 4 11:16 425 19.4 59 5 11:17 226 19.3 36 4 11:18 439 19.3 17 2 11:19 211 19.3 40 3 11:20 272 19.6 12 2 11:21 91 19.7 3 2 11:22 71 20.2 0 2 11:23 69 20.1 0 2 11:24 62 20.1 0 2 11:25 61 20.2 0 2 11:26 54 20.4 0 2 11:27 45 20.4 0 2

Average 331 19.8 53 5


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Time Temperature Oxygen co NOx oc o/o mg/Nm" mg/Nm"

11:32 406 19.6 0 2 11:33 435 19.4 19 2 11:34 430 19.3 5 2 11:35 411 19.3 17 2 11:36 424 19.3 24 2 11:37 279 19.3 21 3 11:38 442 19.5 7 1 11:39 415 19.3 12 2 11:40 436 19.3 19 2 11:41 421 19.3 33 2 11:42 171 19.3 24 3 11:43 156 19.3 4 2 11:44 354 19.3 2 2 11:45 417 19.3 12 1 11:46 270 19.4 11 2 11:47 88 19.5 2 2 11:48 371 19.6 6 2 11:49 400 19.5 14 1 11:50 256 19.5 55 2 11:51 165 19.5 4 1 11:52 149 19.5 7 1 11:53 224 19.5 17 1 11:54 65 20.1 0 1 11:55 61 20.2 70 1 11:56 59 20.2 4 1 11:57 62 20.3 0 1 11:58 63 20.3 0 1 11:59 63 20.1 0 1 12:00 47 20.1 0 1 12:01 49 20.1 0 3 12:02 45 20.0 0 3

Average 246 19.6 13 2


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PRrdn1tterfitme 10.14-1M4 t0,59-11.U U.32-12.02 Snrnvml'Y snrnmn• Snrn\'/Dn·

Temperature (°C) 53 -499 45- 47S 47 -442 O~s Flow Rnte (Nut1.lh) 8961 9947 10294 Oas Flow Rate (Nm1ih)

Diynnd 18%011.ye:en 4~0) 3725 447S Oxygen % (Diy gas) 19.4 19,8 19.6

Nole: Concentration of emissions (,ng!Nm3) were c<1Jc11lated and reported at reference condltlons, temperature 27~K, pressure 101.3 kPa, no correcttonfor moisture or oxygeir

Pnrnmeter/Jim~ - Aerni!}· 10.'z.1-10.54 10.M-11.29 11.31-12.02 S1ml\'ID1i· Stmw/Dn• S1mw/D11·

Tot.it orgaruc c:aroon (as C) s.o 7.3 8.6

Nilrogen OKfdes (as NOl) 13 5 2 Cawon Monoxide (CO) 454 53 13

Thtnnal Oildl~er Eud,$lons (A2~1}-- Couc~ntra.tlon mg/Nm1

No Co1ncttou fo1· l\Iolstur~ 01• Oxygen

Table 1: Concentrations mg/Nm3 (No Correction for Moisture or Oxygen)

DETAILS OF INCIDENT Emission limits exceedence during quarterly monitoring testing occurred for Carbon Monoxide. The limit of l 00 mg/I was breached during the first period I0:24am-10:54am to the value of 895 mg/Nm3 and during second period 10:59am-11 :29am by the value of 140 mg/Nm3. Currently, during monitoring, Rottapharm is receiving two sets of data. Firstly for no correction of Moisture or Oxygen and secondly, as per its IPPC license, corrected to Dry Oas and 18% Oxygen. Rottapharm understands that the abatement system does not require any correction for these two parameters. Therefore, the elevated limits of CO are partially down to different calculation parameters. This issue is being dealt with under the Air Abatement Test Programme In addition, gas flow rate was exceeded which is being dealt with via EPA correspondence P0886- 0l/gc04cc

RTO {Al-1) RTO 28/10/2010

>·:'".::{!8Lt@M~~#~iJ:ii':i<<·:ffrJLf~~:f {i~fm}.1/\E·';,~·J;_; ~r.~~~p1f Ki\~::'.£Ai.1·•~lr,1i ; ~,,;, ~~01i:c<, ,\C·::x:C,':Ji,';;:'

Thermal Osldlser Eruh~lons (A2-1)- Flue GAS Conditions

Environmental Incident Report Em No: 10-02 ~ ADTTRFIHRRl\ll'u.,_

Environmental health & safety and Secudty Reporting i....:S::..:Oc:::P,...._N-_.___--:0"'-: ----l---'E=-:N'--'-G-=:.--=O:.=Sc:c.:H,___-Oc__cOc,:.8~ Procedure -Ap cndlx 4 REVISION NO: 07

SOP TITLE:

AppendixD

32

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33

During planned solvent coating in the production area, the emission llmit value in the RTO was breached causin a release of carbon monoxide out of s clflcation to the IPPC License. The solvent coatin that

Table 2: Concentmtions mg/Nm3 (No Correction for Moisture or Oxygen)

Thenoal O.d<Uier Emlsdont (A1·l)- Concentr11tton mg/Nm1

Cowected to Dry Gtu 1111d 18% Os:ygen

Paramete-r/Tlme 10.2.f-10.54 10.59-11.1~ 11.31-12.02 S1m1YIDn· Sprn\·fD1y Spra,·ID1"\'

Total organic tatbon (C} 9.9 19.4 19.6 Nitrogen Oxl~s (as NO,) 25 12 4 Carbon Monoxide. (CO) 895 140 2!>

'IbtrmAl Oxldlser Emissions (A1·1)-Flur G~, Condlllon.s

Pnrarueler/Ihut 10.24 -10.54 10.59-U.29 11.32 - J2.01 Snrav/Dn' Snn1y(Dty Snr11v/DrY

Temperature (9C) 53 • 499 4.S • 478 47 • 442 Oas Flow Rate (N111'A1) 8961 9947 10294 Oas Flow Rete (Nm'Jb)

DJ)' and J 8% Ox)'geu 4503 3725 ·1175

Oxye,eu % (DI)' ~11s) 19.4 19.8 19.6

Nole: Concentratlon of emissions (mg/Nm3) 11'4'1'0 calouloted and reported a per Licence reference condltlons, te111pe1·a111re 273' K, pre,s11reJOI.J ki'a; dry gas nnd corrected to 18% O.\"ygen

REPORTED BY I Dale: 12f11f201 O Name: Peter O Sulllvan Deoartment: EHS IMMEDIATE REMIDIAL ACTION TAKEN (tostop,CC!111olorcon1a1:10telrdlmt)

• Notification to relevant authorities upon receipt of report . • Investigation launched into occurrence of exceedence • Review meeting between EHS Advisor and Process Engineer

PESCRIPTION OF INITIAL IMPACT (Oelai!them~uttectedoq»tutlonrec:ep!ot) There was no detectable Impact to the surrounding environment. The highest readings of CO were during the initial stages of sampling and reduced significanUy as the monitoring campaign continued. The exceedence was not a significant environmental Incident and therefore Is referenced as a Category 3 environmental Incident.

Emission to Watercourse tJ COMMENTS Emission to Air ,/ Full Investigation launched to Investigate the Soll Contamination 0 exceedence. Hazardous Matorlal Spillage D Damago to plant or property 0 Explosion tJ Waste (haz & non-haz) 0 Gas leak 0 Other (please -.df'I ovec\

DETAILS OF EVENTS LEADING UP TO INCIDENT (exp1a1n oeail)'llow e1'81lt occmed, ~l!be 'o(tm'i.!es, stllcll ske:ches, pholcg12pis, S.0.8.'s, logs, s~s!s fe!uUs, C0111PQ$ilfcn dela:~s. n<111 rates, 60P's etc)

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34

Investigation into RTO condition for this monitoring Caroline Rocks December 2010 campaign, Hlstorlcal review of previous monitoring cam al ns ma be merited

i~l~i~KB~lf l.~1ltntlti:1ki:s?Zlt'..f (ff~rr~rrnrci'tn1i;Jm{f 't\\IJl1m:;1z'~~~11tI?tf i!f tf :~.Jt lti?}Jf i@1if l;;~JJ:f t if:tt~iii*i~~i?iw~ro·----~,i~wti!tg1twMifl\i: .. .ti}i :t1r111~~Wi%i:11 t'.}IJ~xii~i titm1 Quarterly monitoring should not require correction to Peter O Sullivan March 2011 Dry Gas and 18% Oxygen. No correction is required. This is currently being dealt with under Air Abatement Test Pro ramme

Nfa

H,S,A Notified D HEALTH & SAFETY IMPACT (lfepptlcable,<!etaHhena:essaryslteprw.uUoosL11piace)

Nia

DETAIL AUTHORITY FOLLOW UP IF REQUIRED

::,:.:\l;{Irnt11;i1~fK.'f.~\·>;c:i:':.!Yt{H\tJ{if ftI~~Qff(9FJ.NStg,~~.t:}~{f fJg,1,i:l}J;g?J@J1tLX>:fi:it\rt: :,:;.::, \CAT];f p JfI?J.i?t:\d ·aAJ\2\'t:JU~l;;}J>iU{I :cAr.:~t:!Z:t:-t??i'.ittrn1:NEARLMJS$./O:D 0:\ ···\/,'., AUTHORITY NOTIFIED BY FAX AND PHONE ./ (COPYOFFAXMUSTBEATTACHEO) PHONE CONVERSATION DETAILS (lncluoanameofcootsd.~rr.a&da{aofcooversetiool Lisa Maher contacted at 16:00pm on tho 1211112010 Office of Environmental Enforcement, Environmental Protection Agency, Regional Inspectorate, Mccumiskey House, Rlchvlew, Clonskeagh Road, Dublin 14

t:\::N~111zrr 11Jf r:2~1~;rff tt::J:mtt0tIJ:Jii}f 1:~iEf :t11;:=r;tf If::;1t~:t)~tutrm1;:1~=11ttrJ}rtt it ;zr-W Jtt(;t@:rWJtr:}r~t \.:_:;·;\)}JJrnfi:J:t{r.o:.::_.'·,:;:;,,>t}~}~JJ,TH.9RJI.'(f)IQT!~!~l;Hft~N(l9,'§Q!;')/tStff;t.::?Y.}t\?1f)t:'.f'.r·??':({t EPA ./ I FINGAL cc D j FISHERIES BOARD O I HSE (EHO} D

UNDERLYING CAUSE(S) Further investigation required of start up of RTO, as this is when the CO limits spiked.

CONTRIBUTING FACTORS I IMMEDIATE CAUSES • There was no lndicatlon of CO exceedence during the sampling • Cause of CO generally due to incomplete oxidation of carbon containing compounds I.e.

Incomplete combustion • The Regenerative Thermal Oxidiser operated according to Its manual, attaining all

parameters set out in Rottapharm' s IPPC Licence • Calibration Certijicates from supplier showed no anomalies • Stack tasting contractor provided calibration certificates for equipment used.

occurs ls part of the manufacturing process for Tromalyt and occurs periodically throughout a production year.

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(All DOCUMEHTA110N MUST BE A TT ACHED TO TH 1$ REPORT

Uamo EHS ADVISOR: Peter O Sullivan

Stack testing company to be reviewed against Peter 0 Sullivan December 2010 reaulrements of AG2 Contact with suppliers of abatement equipment to Caroline Rocks December 2010 ascertain anv notenflal causes of exceedence Complete monitoring of start up of RTO to ascertain Stack Tester February 2011 whether there Is Issue with combustion

.- .... PREVENTATIVE ~CTIONS .& FOp, •. ow.~ UP REYll:W

Likelihood of continuation NO./' YES Likelihood of recccurrencs LOW./ MED HIGH

CHANGES MADE TO THE FOLLOWING Documents -I' I Design D I Resnonslbllltles ./ Materials D Eaulpment D l Workplace D I Manaaement ,/' Monitorlna D CLOSE OUT OF ALL ACTIONS: ./ DATE: December (Action 1 not relevant to Investigation of method and equipment) 21512010 REPORT SUBMITTED TO AUTHORITIES ./ I DATE: (COPY ATTACHED)

~'" · ·; .~ · - ' •• ·' • ·, •• • ·: • ·,··1,.·;· ••· '- · l •: :e~•.:_.'.,J.~.-.-:~-;-.:..y . .::,:._.c-..;:,.!.·~·.;-~·,. '- ••. - ·· --: : •• •' ·~·:, •• ~:·.-a· · .. , ·', - '-· •-'-. ""·"· -.,~,~ J "-'"'~ .:':.· t.--~- ~. •·-: ~ • ·. • ·• • ; ', -· .-. ·- •• - • •..:.,; ;· •. ~, ,, •. ·-.~'.i-··\s-·'.· . • .... -··· ; . -. ~' ,- ·:·: :·-·-·~.- .... ,'-:. - -. ~ .

35

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PM GROUP

IE0311736-LET-0002_1_01.DOCX

162.TP.15, Issue 7, 10/12/2015

Saudi Arabia

Singapore

Slovakia

Turkey

UK

USA

T

E

W



Belgium

China

Czech Republic

India

Ireland

Poland

Russia

+353 1 404 0700

[email protected]



PM Group

Killakee House

Belgard Square

Dublin 24

Ireland

Attachment 4 Locations of Groundwater Monitoring Wells (IE0311736-22-DR-0007)

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A MEDt.li a RDTTRPHRRM

ROTTAPHARM LTD.

INDUSTRIAL EMISSIONS LICENCE REVIEW

GROUNDWATER WELL LOCATIONS

IE0311736

IE0311736-22-DR-00071:1500

NOTES

LEGEND

GW1

GW2

GW3

GW4

FORMAL ISSUE

GW1

GW2

GW3

GW4

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PM GROUP

IE0311736-LET-0002_1_01.DOCX

162.TP.15, Issue 7, 10/12/2015

Saudi Arabia

Singapore

Slovakia

Turkey

UK

USA

T

E

W



Belgium

China

Czech Republic

India

Ireland

Poland

Russia

+353 1 404 0700

[email protected]



PM Group

Killakee House

Belgard Square

Dublin 24

Ireland

Attachment 5 Updated Non-Technical Summary

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Attachment 5 Non-Tech.doc Page 1 of 12

Non-Technical Summary

1 Introduction

Rottapharm Ltd., trading as Meda Manufacturing Dublin, is part of the Meda Group,

which has its headquarters in Solna, Sweden. Rottapharm Ltd. was part of Rotta

Research Group, which was founded in Italy in 1961, but has since joined the Meda

Group in 2014.

Meda is a leading international specialty pharma company with a broad product

portfolio reaching more than 80% of the global pharmaceutical market. There are

three key therapy areas – Respiratory, Dermatology and Pain and Inflammation –

accounting for around 50% of Group sales.

At the end of 2014 Meda had 5,202 employees. The company’s main focus is sales

and marketing and Meda has its own sales organizations in more than 60 countries.

Sales and marketing activities are carried out via distributors in countries where Meda

has no representation and globally Meda’s products are sold.

Meda AB is the parent company and its head office is located in Solna, Sweden. Meda

was listed in 1995 at the Stockholm stock market and since 2006 listed under Large

Cap on NASDAQ Stockholm in Sweden.

The Rottapharm Ltd. facility in Dublin has been constructed to manufacture solid oral

dosage products and bulk active material. It is a fully integrated unit incorporating

manufacturing, packaging, warehousing, laboratory facilities, utilities and office

accommodation.

The Rottapharm Ltd facility in Dublin consists of two discrete buildings: Administration

and Production / Warehouse linked by enclosed corridors. Construction was completed

in 1999.

The Administration building is a 2-storey steel framed building with a precast concrete

first floor and metal deck roofing. The Production building is composed of a steel

structure with metal deck roofing and a concrete slab in parts of the first floor to

support plant and equipment servicing the production facility. The Warehouse is a

single storey steel structured building with a long span roof truss and a combination of

block work with architectural sheeting to the perimeter walls.

There are approximately 175 employees on the Dublin site.

The Rottapharm Ltd. plant is located in Damastown Industrial Park, Mulhuddart,

Dublin 15 on fully serviced lands zoned for industrial use. The site is located adjacent

to the M3/N3 Dual Carriageway within the valley of the Tolka River. The site occupies

12.5 hectares (31 acres). The site is generally surrounded by other industries within

the industrial park, e.g. Astellas Pharma, Helsinn Chemicals and Helsinn

Pharmaceuticals, and Mallinckrodt Pharmaceuticals.

The nearest sensitive receivers (residential area) are located approximately 500m to

the south of the site on the south side of the N3.

Rottapharm Ltd. is applying to the Environmental Protection Agency for a review of its

Industrial Emissions Licence (Reg. No. P0886-01) in order to amend current erroneous

information in relation to volumetric flow rates from the regenerative thermal oxidiser

(RTO) in the current licence and also accommodate a number of minor changes on-

site, as follows:

- Fitting out of existing fallow space (Area 4) with new manufacturing operations and

associated minor emissions

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- Formalise change to the monitoring frequency of Total Organic Compounds (TOC)

at the RTO (licensed main emission point A2-1)

- Detail new 26kW hot water boiler installed on-site

- Change one of the licensable activities from activity 12.2.2 to 12.2.1 of the First

Schedule of the Environmental Protection Agency (EPA) Act 1992 as amended

- Clarify requirements in relation to firewater retention

2 Hours of Operation

The facility normally operates a 2-cycle shift: 7am-3pm and 3pm-11pm, 5 days a

week, with regular overtime working on Saturdays and Sundays, however Production

and Packaging may operate 24 hours/5 days or 24 hours/7 days cycles depending on

operational needs.

Office hours are from 8am to 5pm.

3 Class of Activity

The main class and nature of the Industrial Emissions Directive (2010/75/EU) activity

carried out in accordance with the First Schedule to the Environmental Protection

Agency Act 1992 (as amended) is ‘5.16 The production of pharmaceutical products

including intermediates’. The equivalent Industrial Emissions Directive category is 4.5.

Another Industrial Emissions Directive activity carried out at the site in accordance

with the First Schedule to the Environmental Protection Agency Act 1992 (as

amended) is ’12.2.1 The surface treatment of substances, objects or products using

organic solvents, in particular for dressing, printing, coating, degreasing,

waterproofing, sizing, painting, cleaning or impregnating, with a consumption capacity

of more than 150 kg per hour or more than 200 tonnes per year’. The equivalent

Industrial Emissions Directive category is 6.7.

4 Environmental Impact Statement and Planning

The original planning application for the facility was submitted in 1998 and was

accompanied by an Environmental Impact Statement (EIS).

There have been a number of subsequent applications made for expansion projects at

the Rottapharm site. A full planning history has been included in Section B of the

licence review application.

All subsequent applications for the various expansions on site did not require an EIS

due to the nature and scale of the works associated with the applications. This was

confirmed during correspondence with the relevant planning authority, Fingal County

Council.

An assessment has been carried out as part of the licence review application on the

environmental impacts from the expansion projects since the original EIS was

prepared, which is included in Attachment A.1 of the application. This assessment

concluded that these expansion projects do not have the potential to have a significant

impact on the environment in the areas of emissions to atmosphere, surface water,

sewer, soil and groundwater and noise emissions, in combination with the impacts that

were outlined in the original EIS for the site. Further assessments of human beings

and the interaction of environmental factors have also been carried out determining

that predicted significant effects do not arise as a result of the development.

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5 Best Available Techniques (BAT)

Under the new Industrial Emissions Directive, the emission limits and equivalent

control parameters for licensed facilities should be based on the principles of Best

Available Techniques (BAT). A review has been completed of BAT associated with the

Rottapharm site.

The Best Available Techniques Reference Documents (BREFs) and EPA BAT Guidance

Notes that have been assessed are;

- Manufacture of Organic Fine Chemicals BREF, 2006

- Surface Treatment using Organic Solvents BREF, 2007

- Common Waste Water and Waste Gas Treatment/Management Systems in the

Chemical Sector BREF, 2003

- Energy Efficiency BREF, 2009

- Emissions from Storage BREF, 2006

- Monitoring of emissions from IED-installations REF, 2003

- EPA BAT Guidance Note for the Use of Solvents, 2008

- EPA BAT Guidance Note Pesticides, Pharmaceuticals & Speciality Organic Chemicals

Sector, 2008

The BAT review tables which are included as part of Section I.8 of the main

application, outline whether a particular conclusion is relevant to the site and how it is

implemented.

6 Seveso Classification

The quantities of chemicals stored on site are below applicable thresholds of the EU

(Control of Major Accident Hazards involving Dangerous Substances) Directive

2012/18/EU and The Chemicals Act (Control of Major Accident Hazards Involving

Dangerous Substances) Regulations 2015 (S.I. No. 209 of 2015). These regulations do

not apply to the facility.

7 Materials and Processes

The main products currently manufactured at Rottapharm Ltd. are as follows;

- API - Bulk Crystalline Glucosamine Sulphate (CGS)

- CGS Capsules

- CGS Sachets

- CGS Tablets/Caplets

- Extranase Tablets

- Fortilase Tablets

- Ananase Tablets

- Tromalyt Capsules

- Plantaben Sachets

The following products are manufactured in the new Area 4, where they are being

introduced and validated prior to commercial production. Floor plans of Area 4 are

included in Attachment D.

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- Liquid Drops

- Uralyt-U Granulate

- Zymafluor Tablets

Other minor products may also be packaged on site such as Spagulax, Colofiber and

Legalon.

Glucosamine Sulphate is a low molecular weight and chemically defined compound

(C12H28N2O14S). It is the sulphate salt of the natural amino-monosaccharide

glucosamine which is physiologically present in the human body. CGS is a stable, non-

hygroscopic crystalline substance synthesized in a 3:1 Glucosamine Hydrochloride:

Sodium Sulphate reaction ratio (in the presence of purified water) in a biconic-rotating

blender. CGS is the only active ingredient used in the manufacture of CGS capsules,

sachets and tablets/caplets. It is a selective symptom-modifying drug for

osteoarthritis.

The CGS capsules, sachets and tablet/caplets are medicinal products used for the

treatment of all forms of degenerative osteoarticular disease.

The process to manufacture the capsules involves weighing, sieving, blending, filling

and packaging.

The process to manufacture the sachets involves weighing, sieving, blending, filling

and packaging.

The process to manufacture the caplets involves weighing, granulating, blending,

compressing and pre-insulation of tablet cores, and film coating.

Extranase tablets are beige, sugar coated, broad spectrum anti-inflammatory tablets.

The active ingredient in Extranase is the active Bromelain. The process to manufacture

the tablets involves weighing, sieving, blending, compressing, coating, polishing and

packaging.

Fortilase tablets are yellow sugar coated tablets and are used as a food supplement. It

contains the nutritional ingredient known a Bromelain as the active. The process to

manufacture the tablets involves weighing, sieving, blending, compressing, coating,

polishing and packaging.

Ananase tablets are orange sugar coated tablets, used as an anti-inflammatory; it also

contains the active Bromelain. The process to manufacture the tablets involves

weighing, sieving, blending, compressing, coating, polishing and packaging.

Tromalyt capsules are a medicinal product which contains acetylsalicylic acid in the

form of prolonged release micro-pellets. The process to manufacture this blend

involves two phases of coating, sieving, blending and encapsulation.

The Plantaben sachet product is a medicinal product containing the husk (Ispaghula)

of the Plantago ovata seed. This husk is a source of natural, concentrated, soluble

fibre, which is often used as a source of insoluble fibre and is well-accepted as a safe

and effective intestinal regulator. The product is a palatable orange-flavoured, sugar-

free powder formulation for the oral administration of Plantago ovata husk. The

process to manufacture this sachet involves weighing, sieving, blending, and

packaging.

The process to manufacture the “Liquid Drops” involves dispensing and sieving,

solution preparation and transfer, filling and packaging. Excipients are generally

pharmacologically inactive substances used as a carrier for the active ingredients of a

medication.

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The Uralyt-U Granulate process is composed of dispensing and sieving, solution

preparation, spray drying and granulation, milling, granulation, filling and packaging.

Excipients are generally pharmacologically inactive substances used as a carrier.

The Zymafluor tablet process is composed of dispensing and sieving, blending, milling,

granulation, compression and packaging. Excipients are generally pharmacologically

inactive substances used as a carrier for the active ingredients of a medication.

Other activities at the facility include the main plant laboratory where central quality

control and quality assurance activities are carried out, and the various utility systems

for the site, e.g. boilers, air conditions, purified water, compressed air, and water

chiller.

8 Atmospheric Emissions

There is one main emission point at the facility - the Regenerative Thermal Oxidiser

(RTO) (Emission point A2-1). This abatement unit treats emissions from the

pharmaceutical coating systems on-site that use solvents.

There are a total of 35 No. minor emission points at the facility, A3-1 to A3-35.

There are no significant boiler emissions points at the facility, i.e. all gas fired boilers

on site are below 5MW. Furthermore there are no liquid fired boilers at the facility. All

boiler emissions are included in the site’s minor emission points.

Details of all of the above emission points are included in the Tables contained within

Section E of the application form.

Rottapharm Ltd. produces an annual Solvent Management Plan, in order to comply

with Condition 6.19 of its current licence Industrial Emissions Licence. This documents

a solvent mass balance for the installation and compares the calculated VOC (Volatile

Organic Compounds) emissions to determine solvent emissions from the installation

and verify compliance with the stated limits in their Industrial Emissions Licence for

emissions in waste gases and fugitive emissions.

There is no significant potential for emissions to cause odour nuisance off-site.

9 Emissions to Surface Waters

Surface water from the impervious areas on-site is discharged from the site at two

locations, SW1 and SW2.

SW1 is the outfall from the on-site surface water attenuation pond and this water

discharges to the River Pinkeen. SW2 discharges surface water to the River Pinkeen

on-site upstream of the administration building.

Petrol interceptors are provided on the drainage system upstream of the two emission

points to prevent emissions of hydrocarbon pollutants to surface waters in the unlikely

event of a spill on-site. Furthermore there is an automatic shut-off valve on the outlet

of the surface water attenuation pond allowing it to be isolated if required.

Both discharge locations are monitored quarterly for pH and TOC (Total Organic

Carbons) and are visually inspected weekly, in accordance with the site’s current

licence requirements.

10 Emissions to Sewer

Rottapharm Ltd. currently has one licensed emission point to sewer, SE1. This has not

changed and will not change as part of this licence review. Process emissions are

discharged to sewer at emission point SE1. It is noted that there is a second emission

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point, SE2, which only emits foul/sanitary effluent to the local authority sewer. This

has not changed since the previous licence application.

Rottapharm Ltd. carries out a programme of monitoring and maintenance of its

effluent system. The licensed trade effluent is held in a balancing tank prior to

discharge to the sewer. As well as the continuous final effluent flow and pH

monitoring, effluent discharge is monitored for the following parameters on a monthly

basis:

- Temperature

- COD

- BOD

- Suspended Solids

- Sulphates (as SO4)

- Oils, Fats and Grease

- Methylene Blue Active Substances (MBAS)

11 Emissions to Ground/Groundwater

There are no emissions to ground or groundwater from the facility.

12 Noise Emissions

There have been no significant changes to the number and nature of noise sources

since the original licence application. There are no new significant external noise

sources associated with any of the changes on-site. Any changes to the facility under

review as part of this application are housed indoors.

Noise emissions from site are reported in the Annual Environmental Report. Any

changes as part of this review will be monitored as part of the periodic noise surveys.

13 Waste

Rottapharm Ltd produces waste on an on-going basis throughout the year. Both non-

hazardous and hazardous wastes are produced at the site. As outlined in the SOP for

waste management at the site the main waste streams are as follows:

Non-Hazardous Waste

- Cardboard

- Plastic

- Mixed dry waste (mix of hard plastics and cardboard that needs to be compacted

and cannot be baled)

- Non-hazardous solid pharmaceutical waste (powders and capsules)

- Metals

- Waste Electrical and Electronic Equipment (WEEE)

- Timber

- Canteen and office waste (food, mixed dry recyclables, and municipal waste)

Hazardous Waste

- Machine oil

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- Manufacturing and lab chemical waste

- Hazardous solid pharmaceutical waste

Rottapharm Ltd.’s approach to dealing with waste arisings is based on the

internationally adopted hierarchy of options which places greatest emphasis on:

- Waste Prevention

- Minimisation

- Reuse/Recycling

- Energy recovery

- Environmentally sustainable disposal of waste which cannot be prevented or

recovered

Various measures for waste control and minimisation have been implemented by

Rottapharm Ltd. including the use of aqueous based coating solutions to reduce

solvent waste, and inventory control to prevent over-ordering of raw materials.

All recyclables from Rottapharm Ltd. are collected and managed by an approved waste

contractor and suitably permitted/licensed facility.

Food waste is managed in accordance with the Waste Management (Food Waste)

Regulations 2009. The canteen area has dedicated waste containers for food waste.

All wastes are stored, collected, transferred, disposed of and/or recovered in

accordance with national and European waste management legislation.

14 Control and Monitoring

At the time of design an assessment of various types of abatement technologies for

the treatment of VOC (Volatile Organic Compounds) emissions was carried out to

determine which method is most appropriate for the abatement requirements. It was

concluded that emissions to air of solvent vapours would be treated and controlled by

the use of regenerative thermal oxidation.

The regenerative thermal oxidiser (RTO) installed on-site is designed and built in

accordance with all recognised standards including:

- European Standards for “Best Available Techniques” (BAT)

- British standard or European Norm where applicable

- ATEX where applicable

- CE certification

- Irish and European Environmental emission regulations

Quarterly emissions monitoring is carried out on the RTO. According to Rottapharm

Ltd.’s Annual Environmental Report for 2014, there was one non-compliance in

relation to hourly flow rates from the RTO, however this is due to the on-going issue

that the incorrect flow rates for the RTO are contained in the licence. Monitoring of all

other parameters/pollutants was compliant with the limits set out in the existing

Industrial Emissions Licence.

A test programme for the RTO has been submitted with the licence review application.

This test programme has been developed in accordance with Condition 6.1 of the site’s

Industrial Emissions Licence.

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The site’s two licensed surface water discharge points are monitored quarterly for pH

and TOC (Total Organic Carbons) and are visually inspected weekly, in accordance

with the site’s current licence requirements. Based on recent monitoring carried out on

the site’s surface water discharges it can be concluded that the overall impact on

emissions to surface water from Rottapharm Ltd. is not significant, and any expansion

projects since the previous licence application have not had a significant impact on the

site’s surface water discharges. There are 5 No. Class 1 interceptors at the site, 3 No.

Class 1 by-pass interceptors for car parks and general gutters/gullies (east of the

site), and 2 No. Class 1 full retention interceptors for the Warehouse loading bay and

for front of Admin building (access road & staging area).

Rottapharm carries out a programme of monitoring and maintenance of its effluent

system. The licensed trade effluent is held in a balancing tank prior to discharge to the

sewer in order to carry out pH adjustment if required. Control of the balancing system

is achieved through influent flow and pH monitoring, output pH monitoring, and final

effluent flow and pH monitoring. Daily inspection of sludge condition/volume is also

carried out.

As well as the continuous final effluent flow and pH monitoring, the following

parameters are monitored on a monthly basis:

- Temperature

- COD

- BOD

- Suspended Solids

- Sulphates (as SO4)

- Oils, Fats and Grease

- Methylene Blue Active Substances (MBAS)

There are no discharges to ground or groundwater; therefore no monitoring is

applicable. However there are 4 No. groundwater wells installed on-site, GW1 to GW4.

Details of these and a map showing their locations have been supplied to the EPA with

the licence review application.

Periodic noise monitoring is carried out at 3 no. noise sensitive locations off-site. Noise

monitoring carried out as part of the 2015 reporting period demonstrated that there

were some levels higher than those limits in the site’s licence. However, the

consultants who carried out the survey noted that these limit breaches were due to

traffic noise in the area and could not be attributable to the facility’s operations.

Furthermore there were no noise complaints received during the 2015 reporting

period.

15 Environmental Considerations

Rottapharm Ltd. has continually invested in BAT (Best Available Techniques) based

technologies. The on-site RTO for the abatement of Volatile Organic Compounds

complies with European Standards for Best Available Techniques.

Rottapharm Ltd. endeavours to recover and recycle waste where possible. Where this

is not feasible, disposal of waste is conducted using licensed waste hauliers and

licensed waste facilities in order to minimise any environmental impact.

Rottapharm Ltd.’s Emergency Response Procedure outlines the accident prevention

and emergency response procedures in place at Rottapharm Ltd. in the event of a fire,

a spill of flammable or environmentally harmful material, or any other major industrial

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accident. Emergency response training is also provided to all Rottapharm Ltd.

employees.

16 Accidental Emissions

All operations and activities are carried out in accordance with the relevant

Rottapharm Ltd. procedures, which are designed to minimise accidents. Rottapharm

Ltd. has developed an Emergency Response Procedure which sets out the responses to

such events in order to minimise any consequences for the environment.

17 Energy Efficiency

Rottapharm Ltd monitors and reviews energy use to identify and achieve energy

efficiencies.

An energy policy with an updated energy action plan is drafted each year and a review

report is written on energy management at the end of the year. An energy

management team consisting of a cross functional selection of representatives from

different departments is in place to champion the efficient use of energy across the

plant. The energy management system follows the SEAI Energy MAP (Management

Action Plan). All teams within the plant have access to an electrical energy

measurement and reporting platform. Teams highlight a visual display of the electrical

energy usage for their area or in shared areas (offices) on their visual management

board. Teams are questioned on energy use during senior management reviews, best

practice methods have been introduced to promote the shutdown of equipment when

not in use. Rottapharm Ltd. also held an energy awareness competition raising ideas

to reduce energy and waste. Some of the ideas were simple such as putting stickers

on lights to remind people to turn them off and to investigate ways to reduce heating

requirements within the building.

Over the last number of years Rottapharm Ltd. have implemented a number of

projects to reduce energy usage, including implementing changes in the de-

humidification system to dehumidify machine cabinets rather than complete rooms;

implementing a reduction in chilled water pump speed; and replacing lighting with

energy efficient LED lighting.

Rottapharm Ltd. continuously looks to improve its energy usage and have a number of

further projects which it plans to implement in the coming years, such as investigating

the possibility of changing the chilled water system from a 3 port operated system to a

2 port on demand control with the pump controlled by differential pressure, for

example.

An external audit was conducted in 2009 by SEAI; many of the recommendations have

been implemented. An internal audit for opportunities was carried out in July 2013

and recommendations are also being implemented.

Internal checks on equipment shutdown during off peak periods are conducted twice a

year within each team/area and scores of compliance to shutdown rules are trended

for each team.

The most recent full year data for energy use is available in the 2014 Annual

Environmental Report for the facility. The 2014 Annual Environmental Report reported

total energy use for the facility of 6,766MWhrs, which comprises electricity

consumption of 4,225MWhrs, and natural gas consumption of 2,541MWhrs.

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18 Statutory Requirements

The emissions from the Rottapharm Ltd. facility will not result in any significant

environmental pollution as required by the relevant legislation.

Air dispersion modelling was carried out for the RTO in October 2010 with the correct

volumetric flow rate at the licensed emission limits and it demonstrates that the

emissions from the RTO have no significant effect on the environment and do not

breach statutory Air Quality Standards. Further modelling of the VOC emission from

the RTO was also carried out in April 2016 and has shown that the VOC emissions

from the RTO will not lead to a significant environmental effect. This modelling

exercise also determined that cumulative modelling taking into account nearby

installations was not required due to the fact that emissions from nearby facilities are

not significant. This determination of the requirement for cumulative modelling was

carried out in accordance with the EPA guidance note Air Dispersion Modelling from

Industrial Installations Guidance Note (AG4).

The changes proposed in this licence review will not result in any change to emissions

to surface water or sewer. Emissions to sewer and surface water will continue to

comply with the conditions of the current Industrial Emissions Licence.

The proposed facility will not lead to a contravention of any relevant standard

prescribed under the European Communities Act 1972, or under any other enactment.

There are no predicted significant impacts associated with the proposed facility.

The proposed changes will not result in a significant increase in noise emissions from

the facility. The operation of the facility does not contribute to elevated noise levels at

noise sensitive locations surrounding the site. Furthermore, the plant does not

contribute to tonal or impulsive components at these locations. Therefore, it is

concluded that the facility will continue to comply with section 106 of the EPA act,

1992.

Site waste management procedures ensure that waste is managed based on the waste

management hierarchy and ensures that all waste is handled, stored, labelled,

transported and treated/disposed off-site in accordance with statutory requirements

and best practice.

Rottapharm Ltd. has employed BAT in construction and upgrades at the works to

ensure it minimises its impact on the local environment. Where possible, the

generation of waste streams at source is avoided. Where this is not achievable,

suitable abatement and recovery systems are put in place.

There are no ecological designated areas in the vicinity of the Rottapharm Ltd. site.

Screening for Appropriate Assessment was undertaken as part of this licence review

application. The conclusions from the screening report are that there will be no

adverse effect on any Natura 2000 sites.

Rottapharm Ltd. and the management are fit and proper persons, with the necessary

skills, experience and resources to operate the facility in full compliance with the

licence requirements. Neither Rottapharm Ltd. nor any staff involved with managing

the operations at the facility has been convicted of any offence under the

Environmental Protection Agency Act 1992 to 2011, the Waste Management Acts 1996

to 2011, the Local Government (Water Pollution) Acts 1997 and 1990, the Air Pollution

Act 1987 and the Air Pollution Act 1987 (Environmental Specifications for Petrol and

Diesel Fuels) (Amendment) Regulations 2004.

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19 Cessation of Activity

Rottapharm Ltd. intends to operate at the Damastown site for the foreseeable future.

However, in the event of definitive cessation of activities at the site, Rottapharm Ltd.

will ensure that appropriate measures are taken to avoid any pollution risk and return

the site to a satisfactory state in accordance with the Closure Plan that has been

prepared for the site. This Closure Plan has been submitted to and agreed with EPA.

20 Site Management and Control

The structures for the management and responsibility for the operation and control of

abatement/treatment systems on-site are set out in Rottapharm Ltd.’s Environmental,

Health and Safety (EHS) Statement.

The Managing Director has ultimate responsibility for safety, health and welfare. The

Department Managers have overall responsibility for safety, health and welfare within

their departments. The Engineering Manager has overall responsibility for the

operational control of environmental, health and safety matters, and for the effective

implementation of the EHS Statement.

The responsibilities allocated to the EHS Manager/Officer(s), to the Supervisor(s), to

the Safety Representative(s) and to employees are set out in the EHS Statement.

Training is provided to all employees and managers, including induction training, and

training records are maintained.

Consultation between management and employees is facilitated by the Safety

Representative and the EHS Committee. Accidents and incidents are recorded and

reported as required via an Accident/incident report form. Concerns can be notified to

management using a Safety Observation Report.

The written procedures for the calibration and maintenance systems for engineering

and quality control departments have been prepared by Rottapharm Ltd.

As per design, there is no control system interlock between the RTO and the solvent

coating pans; therefore the shutdown of the coating pans in the event of an RTO

failure is a manual process. Upon a failure of the RTO a beacon sounder alarm is

triggered in the production building, Area 2, where the solvent processes take place

(in addition to any other local and remote RTO alarms). If the alarm is triggered, SOP

PRO-MAN2-033 requires the operators to stop the coating process immediately and to

record that using the forms within the SOP.

The written procedures for waste control systems have been prepared by Rottapharm

Ltd. Each department is responsible for the segregation and presentation of waste as

generated by that department.

Rottapharm Ltd.’s emergency response procedure outlines the functions of the

chemical spill team. This requires the spill team to attend the spill, isolate and

evacuate the spill area, determine substances and quantities involved and to report to

the Engineering Manager/EHS Manager.

Product quality is monitored throughout the process at the Rottapharm Ltd. facility via

an established quality control system. This system is in accordance with ISO 13485 for

medical device products. A Quality Management System for all pharmaceutical

products has also been prepared in accordance with cGMP standards. This Quality

Management System is in accordance with EU 93/42/EEC.

An Environmental Management System has been developed and is in operation at

Rottapharm Ltd. The Environmental Management Plan for the facility is reviewed

annually and updates of objective and targets are included in the Annual

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Environmental Reports for the facility. The Rottapharm Ltd. Environmental

Management System is not an accredited system; however it was developed in line

with the ISO14001 environmental management system standard. Rottapharm Ltd. is

currently in the preparation phase for attaining accreditation for their Environmental

Management System in line with ISO14001. It is currently expected that accreditation

will be achieved by the end of 2016.

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