baseline report in accordance with section 86b of …constructed above area 4. area 4 contains new...

Baseline Report in Accordance with Section 86B of the EPA Act 1992 (as amended)

Issue date: 19 January 2016

Rottapharm Ltd Industrial Emissions Licence Review IE0311736-22-RP-0003, Issue: A

For

insp

ectio

n pur

pose

s only

.

Conse

nt of

copy

right

owne

r req

uired

for a

ny ot

her u

se.

EPA Export 23-01-2016:01:05:22

162.TP.09, Issue 7, 31/03/2014 Formal Issue

Document Sign Off

Baseline Report in Accordance with Section 86B of the EPA Act 1992 (as amended)

Rottapharm Ltd Industrial Emissions Licence Review IE0311736-22-RP-0003, Issue A

File No: IE0311736.22.040

CURRENT ISSUE

Issue No: A Date: 19/01/16 Reason for issue: For EPA Submission

Sign Off Originator Checker Reviewer Approver Customer Approval (if required)

Print Name Paul O’Sullivan Rory O’Dwyer Rory O’Dwyer

Signature Authorised Electronically

Date 19/01/16 19/01/16 19/01/16

PREVIOUS ISSUES

Issue No

Date Originator Checker Reviewer Approver Customer Reason for issue

For

insp

ectio

n pur

pose

s only

.

Conse

nt of

copy

right

owne

r req

uired

for a

ny ot

her u

se.

EPA Export 23-01-2016:01:05:22

Rottapharm Ltd Industrial Emissions Licence Review

IE0311736-22-RP-0003, Issue A 19/01/2016

IE0311736-22-RP-0003_A_01.DOC of 24 Formal Issue

Contents

1 Introduction 4

1.1 General 4

1.2 Reasons for Licence Review 4

1.3 Requirement for Baseline Report 5

1.4 Scope of Baseline Report 6

1.5 Limitations of Baseline Report 6

2 Stage 1: Identification of Hazardous Substances 8

3 Stage 2: Identification of ‘Relevant Hazardous Substances’ 15

3.1 Raw Materials 15

3.2 Hazardous Waste 18

4 Stage 3: Assessment of Site-Specific Pollution Possibility 19

4.1 Quantities of Hazardous Substances 19

4.2 Existing Conditions Underlying the Site 19

4.3 Storage and Containment 20

4.4 Conclusion 23

5 Conclusion 24

For

insp

ectio

n pur

pose

s only

.

Conse

nt of

copy

right

owne

r req

uired

for a

ny ot

her u

se.

EPA Export 23-01-2016:01:05:22


IE0311736-22-RP-0003, Issue A 19/01/2016


1 Introduction

1.1 General

This Baseline Report has been prepared on behalf of Rottapharm Ltd. as part of the application for a review of its current Industrial Emissions Licence (EPA Licence Reg. No. P0886-01). It is based on information provided by Rottapharm Ltd. in relation to chemicals and waste on-site and the hazard characterisation of such materials. PM Group did not review individual Material Safety Data Sheets (MSDSs) of materials.

The application for the licence review is being prepared in order to amend current erroneous information in relation to volumetric flow rates from its regenerative thermal oxidiser (RTO) in the current licence, to accommodate a number of minor changes on-site since the granting of the previous licence, and to formalise a number of other agreements in relation to changes to the licence.

1.2 Reasons for Licence Review

A brief summary of the main reasons for this licence review are outlined as follows:

1. Amend Schedule B.1 to increase the flow rate limit for licensed emission point A2-1. Incorrect flow rate information was provided in the original licence application which was transferred to the licence as limits. A technical amendment request to increase these flow limits was submitted to the EPA in October 2010 and January 2011. However this request for a technical amendment was refused in April 2011 by the EPA on the grounds that it would be more appropriate to deal with the proposed change to the schedule by licence review as opposed to technical amendment.

2. Formalise in the licence review the agreement in relation to the monitoring programme for emission point A2-1, whereby quarterly monitoring was deemed sufficient and continuous TOC monitoring not required. An agreement from the EPA was received 9 March 2010 (EPA Ref: P0886-01/ap01ec), so this change is proposed to be formalised in the Schedule C.1.2 of the licence as part of this review application.

3. Provide details on the new Area 4 operations and associated new minor air emission points. The Area 4 processes do not involve any solvent. Area 4 is being fitted out in an existing fallow space at the facility and new products and processes are being introduced, from development through scale up and eventually commercial production. There was also a new plant room constructed above Area 4. Area 4 contains new processing equipment including a fluid bed processor, high sheer granulator and milling room, 2 new solution vessels with a nitrogen supply for the vessels, and an oven dryer. Waste water emissions from Area 4 arise only due to the CIP of the solution vessels.

- New products and production processes will also be detailed in the licence review for the following products; Liquid Drops process, Uralyt-U process, and Zymafluor process.

4. Provide details on a new 26kW hot water boiler that has been installed in the administration building. This boiler like all others on-site is fuelled by natural gas.

5. It is proposed as part of the review to apply for a change in the class of one of the activities from 12.2.2 (IPC activity) to 12.2.1 (IED activity).

12.2.2 The manufacture or use of coating materials in processes with a capacity to make or use at least 10 tonnes per year of organic solvents, and powder coating manufacture with a capacity to produce at least 50 tonnes per year, not included in paragraph 12.2.1.

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.

For

insp

ectio

n pur

pose

s only

.

Conse

nt of

copy

right

owne

r req

uired

for a

ny ot

her u

se.

EPA Export 23-01-2016:01:05:22


IE0311736-22-RP-0003, Issue A 19/01/2016


Currently the site does not consume more than the thresholds outlined in Activity 12.2.1, however there is the potential for that consumption capacity in the future. The main IED activity at the site is still 5.16 The production of pharmaceutical products including intermediates.

6. This licence review application will clarify the site’s requirements in terms of firewater retention facilities. A firewater risk assessment has been carried out as required by the license which has determined the firewater risk throughout the site as low and therefore no dedicated firewater retention facilities was deemed necessary. This risk assessment will be included in the application documentation.

1.3 Requirement for Baseline Report

1.3.1 European Legislation

The Industrial Emissions Directive (2010/75/EU) or ‘IED’ entered into force within the European Union on 6th January 2011. The IED brings together the Integrated Pollution Prevention and Control Directive (2008/1/EC), the Waste Incineration Directive (2000/76/EC) and five other directives in a single Directive on industrial emissions.

For industrial activities regulated by the IED, such as the Rottapharm Ltd. facility, Article 22(2) of Chapter II of the IED states that:

“Where the activity involves the use, production or release of relevant hazardous substances and having regard to the possibility of soil and groundwater contamination at the site of the installation, the operator shall prepare and submit to the competent authority a baseline report before starting operation of an installation or before a permit for an installation is updated for the first time after 7 January 2013.

The baseline report shall contain the information necessary to determine the state of soil and groundwater contamination so as to make a quantified comparison with the state upon definitive cessation of activities provided for under paragraph 3.

The baseline report shall contain at least the following information:

(a) Information on the present use and, where available on past uses of the site;

(b) Where available, existing information on soil and groundwater measurements that reflect the state at the time the report is drawn up or, alternatively, new soil and groundwater measurements having regard to the possibility of soil and groundwater contamination by those hazardous substances to be used, produced or released by the installation concerned.

Where information produced pursuant to other national or Union law fulfils the requirements of this paragraph that information may be included in, or attached to, the submitted baseline report. The Commission shall establish guidance on the content of the baseline report.”

1.3.2 Irish Legislation

Article 22(2), as part of Chapter II of the IED, was transposed into Irish national law on 23 April 2013 by the European Union (Industrial Emissions) Regulations 2013 (S.I. No. 138 of 2013) and resulting amendments to the Environmental Protection Agency Act 1992.

Section 86B of the Environmental Protection Agency Act 1992, as amended, states that:

“(1) Where an industrial emissions directive activity involves the use, production or release of relevant hazardous substances, and having regard to the possibility of soil and groundwater contamination at the site of an installation concerned, the Agency shall require an applicant under this Part for a licence or review of a licence or revised licence relating to the activity, including such a review by the Agency of its own volition, to furnish to the Agency a baseline report in accordance with regulations under section 89.

(2) In relation to an installation, a baseline report shall contain the information necessary to determine the state of contamination of soil and groundwater at the time the report is drawn up in order that a quantified comparison may be made to the state of the site upon the permanent

For

insp

ectio

n pur

pose

s only

.

Conse

nt of

copy

right

owne

r req

uired

for a

ny ot

her u

se.

EPA Export 23-01-2016:01:05:22


IE0311736-22-RP-0003, Issue A 19/01/2016


cessation (including cessation by abandonment) of the industrial emissions directive activity concerned and the applicant in preparing the baseline report shall include any information prescribed in regulations under section 89.

(3) Notwithstanding the generality of subsection (2), a baseline report shall include at least the following information-

(a) The current use and, where available, the past use of the site,

(b) Any available information.

On soil or groundwater measurements that reflect the state of the site at the time that the baseline report is drawn up, or

On new soil and groundwater measurements, having regard to the possibility of soil and groundwater contamination by the hazardous substances proposed to be used, produced or released by the installation concerned.

(4) Any information furnished to the Agency or to any other body under any enactment or rule of law or a law of the European Union, which complies with the requirements of subsection (2) or (3), may be furnished to the Agency in or with the baseline report.

(5) For the purposes of determining the information to be contained in a baseline report under this section the Agency shall have regard to, and shall for the purposes of subsection (2), make publicly available any guidance documents published by the Commission of the European Union in accordance with Article 22(2) of the Industrial Emissions Directive.”

1.4 Scope of Baseline Report

The European Commission communication European Commission Guidance concerning baseline reports under Article 22(2) of Directive 2010/75/EU on industrial emissions (2014/C 136/03) provides guidance information on the legal provisions concerning a baseline report and covers the following elements of Article 22 of the IED that should be addressed in the baseline report:

- Determining whether a baseline report is required to be produced;

- Designing baseline investigations;

- Designing a sampling strategy;

- Developing the baseline report.

The European Commission communication identifies eight stages/tasks to be undertaken to both determine whether a baseline report needs to be produced for a particular situation and in order to produce the baseline report itself. These are as follows:

- Stages 1-3: to decide whether a baseline report is required

- Stages 4-7: to determine how a baseline report has to be prepared

- Stage 8: to determine the content of the report.

As stated in the EC Guidance “Where during stages 1-3 it is demonstrated on the basis of the available information that a baseline report is not required, there is no need to progress to the later stages. A record of such a demonstration should be made and held by the competent authority, including the reasons for such a decision”.

This Baseline Report will focus on all materials stored at the Rottapharm Ltd. site and is based on information on those materials provided by Rottapharm Ltd.

1.5 Limitations of Baseline Report

The findings herein are based on the latest guidance available and information obtained during the period for preparation of the Baseline Report (November - December 2015). If additional information and/or guidance becomes available, which might alter PM Group’s conclusions, we

For

insp

ectio

n pur

pose

s only

.

Conse

nt of

copy

right

owne

r req

uired

for a

ny ot

her u

se.

EPA Export 23-01-2016:01:05:22


IE0311736-22-RP-0003, Issue A 19/01/2016


reserve the right to review such information, reassess potential risks and modify our findings, if warranted. Please note that where we refer to information in reports from others, it must be recognised that PM Group has no responsibility for the accuracy of the information contained therein.

This report has been prepared by PM Group for Rottapharm Ltd. Any third party using this report does so entirely at their own risk. PM Group makes no warranty or representation whatsoever, express or implied, with respect to the use by a third party of any information contained in this report or its suitability for any purpose. PM Group assumes no responsibility for any costs, claims, damages or expenses (including any consequential damages) resulting from the use of this report or any information contained in this report by a third party.

This report is based on information provided by Rottapharm Ltd. in relation to chemicals and waste on-site and the hazard characterisation of such materials. PM Group did not review individual Material Safety Data Sheets (MSDSs) of such materials.

For

insp

ectio

n pur

pose

s only

.

Conse

nt of

copy

right

owne

r req

uired

for a

ny ot

her u

se.

EPA Export 23-01-2016:01:05:22


IE0311736-22-RP-0003, Issue A 19/01/2016


2 Stage 1: Identification of Hazardous Substances

The EC guidance states that Stage 1 should include a list of all hazardous substances used, produced or released inside the installation boundary.

Rottapharm Ltd. maintains an inventory of all chemicals (hazardous and non-hazardous) used on site. Table 2.1 below outlines all the materials that are stored on site for operations based on information on those materials provided by Rottapharm Ltd., as well the quantity of each material that is normally stored on site, and their hazard classifications as stated in EC Regulation 1272 / 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006.

There are no materials on-site that are stored outside of bunded areas / contained chemical stores.

All pipelines and transfer and storage system associated with the facility has been / will be designed and constructed in accordance with the EPA guidance document “IPC Guidance Note on Storage and Transfer of Materials for Scheduled Activities, 2004” to ensure that a high level of protection is afforded to the environment.

Table 2.1: All Substances Stored On-Site

Substance

Normal Quantity

Stored On-site

Unit Hazard ClassificationNote 1

Diesel 0.25 tonnes H351: Suspected of causing cancer

Biochem 1404 0.01 tonnes N/A

Chemhib201 0.025 tonnes N/A

Acetic acid 0.025 tonnes

H226: Flammable liquid and vapour

H314: Causes severe skin burns and eye damage

Acetone 3.3 tonnes

H225: Highly flammable liquid and vapour

H319: Causes serious eye irritation

H336: May cause drowsiness or dizziness

Acetonitrile hypergrade 0.088 tonnes


H332: Harmful if inhaled

H312: Harmful in contact with skin

H302: Harmful if swallowed


Acetylsalicyclic acid crystalline 0.03 tonnes N/A

Aspartame 0.3 tonnes N/A

A-TAB/Dicalcium phosphate anhydrous

0.524 tonnes N/A

For

insp

ectio

n pur

pose

s only

.

Conse

nt of

copy

right

owne

r req

uired

for a

ny ot

her u

se.

EPA Export 23-01-2016:01:05:22


IE0311736-22-RP-0003, Issue A 19/01/2016


Substance

Normal Quantity

Stored On-site


B-carotene 0.025 tonnes N/A

Bromelain (from pineapples) 0.869 tonnes


H335: May cause respiratory irritation

H315: Causes skin irritation

H334: May causes allergy or asthma symptoms or breathing difficulties if inhaled

Calcium hydrogen phosphate anhydrous

0.624 tonnes N/A

Calcium hydrogen phosphate dihydrate

1.3 tonnes N/A

Sodium chloride 0.019 tonnes N/A

Sodium sulphate 38.649 tonnes N/A

Cellulose acetate phthalate 0.05 tonnes N/A

Citric acid Anhydrous 0.4 tonnes N/A

Diethyl ether 0.006 tonnes

H224: Extremely flammable liquid and vapour



Ethanol absolute GR 0.8 tonnes H225: Highly flammable liquid and vapour

Eudragit 2.7 tonnes


H331: Toxic if inhaled

H311: Toxic in contact with skin

H301: Toxic if swallowed

H370: May cause damage to organs

Glocosamine hydrochloride 359.923 tonnes N/A

Gum Acacia, Gum Arabic 0.175 tonnes N/A

Hydranal - Composite 5 k one component

0.005 tonnes N/A

Hydranal - titrant 5,Titrant component f

0.002 tonnes N/A

For

insp

ectio

n pur

pose

s only

.

Conse

nt of

copy

right

owne

r req

uired

for a

ny ot

her u

se.

EPA Export 23-01-2016:01:05:22


IE0311736-22-RP-0003, Issue A 19/01/2016


Substance

Normal Quantity

Stored On-site


Hydranal composite 0.006 tonnes N/A

Hydranal working medium k solvent

0.004 tonnes N/A

Hydranal working medium k 0.004 tonnes N/A

Hydrochloric acid 0.005 tonnes



Hydrofluoric acid 40% GR ISO 0.005 tonnes

H330: Fatal if inhaled

H310: Fatal in contact with skin

H300: Fatal if swallowed


Lactose monohydrate 3.875 tonnes N/A

Lead (II) Perchlorate trihydrate 0.001 tonnes N/A

OLead Nitrate 0.1M 0.002 tonnes N/A

FACI Magnesium Stearate VG PHAR

0.935 tonnes N/A

Mannitol CRS 0.042 tonnes N/A

Methanol 0.03 tonnes






Microcrystalline cellulose 0.596 tonnes N/A

Opalux 0.075 tonnes N/A

1-propanol 0.022 tonnes


H318: Causes serious eye damage


For

insp

ectio

n pur

pose

s only

.

Conse

nt of

copy

right

owne

r req

uired

for a

ny ot

her u

se.

EPA Export 23-01-2016:01:05:22


IE0311736-22-RP-0003, Issue A 19/01/2016


Substance

Normal Quantity

Stored On-site






Perchloric acid 0.021 tonnes

H271: May cause fire or explosion; strong oxidiser


Plantago 76.44 tonnes N/A

Polyethylene glycol 0.825 tonnes N/A

Polysorbate 60 0.2 tonnes N/A

Primellose 0.05 tonnes N/A

Bleached shellac 0.1 tonnes N/A

Saccharin sodium 1.154 tonnes N/A

Silver nitrate 0.005 tonnes


H400: Very toxic to aquatic life

H410: Very toxic to aquatic life with toxic effects

Sodium bicarbonate 24.374 tonnes N/A

Sodium hydroxide 0.008 tonnes H314: Causes severe skin burns and eye damage

Sorbitol CRS 60 tonnes N/A

Sorbitol instant FG Ph Eur, BP, NF,FCC

9 tonnes N/A

Stearic acid vegetable grade Ph Eur, BP, NF

0.04 tonnes N/A

Sucrose extra pure DAB,Ph Eur,BP,JP,NF

3 tonnes N/A

Talc 0.595 tonnes N/A

Tartaric acid 26.05 tonnes N/A

For

insp

ectio

n pur

pose

s only

.

Conse

nt of

copy

right

owne

r req

uired

for a

ny ot

her u

se.

EPA Export 23-01-2016:01:05:22


IE0311736-22-RP-0003, Issue A 19/01/2016


Substance

Normal Quantity

Stored On-site


Titanium (IV) oxide extra pure ph Eur,BP,USP,JP,E 171

0.05 tonnes N/A

Triethyl citrate Ph Eur,NF 0.006 tonnes N/A

Water Chromasolv for HPLC 0.015 tonnes N/A

pH 4 Buffer at 20C & at 25C 0.003 tonnes N/A

Technical Buffer 0.003 tonnes N/A

Buffer solution Ph2 0.003 tonnes N/A

Buffer solution Ph7 0.003 tonnes N/A

Cleaner 0.024 tonnes N/A

Neutraliser 0.012 tonnes N/A

Cond std 10 0.002 tonnes N/A



Mobil DTE 26 0.42 tonnes N/A

Mobil DTE 25 0.42 tonnes N/A

Mobil Rarus 427 0.05 tonnes N/A

Mobil DTE heavy extra 0.05 tonnes N/A

Chesterton 622 0.005 tonnes N/A

Chesterton 677 dry lubricant (Teflon)

0.004 tonnes N/A

Chesterton 690 pen and lube 0.004 tonnes N/A

Maize starch ph. Eur 4 tonnes N/A

Hard Gelatine Capsules 9 tonnes N/A

Gelatin powder 0.025 tonnes N/A

Ciclidrolo for storage 0.075 tonnes N/A

Simethicone emulsion 0.018 tonnes N/A

Phyllantus amarus extr 3% 0.04904 tonnes N/A

For

insp

ectio

n pur

pose

s only

.

Conse

nt of

copy

right

owne

r req

uired

for a

ny ot

her u

se.

EPA Export 23-01-2016:01:05:22


IE0311736-22-RP-0003, Issue A 19/01/2016


Substance

Normal Quantity

Stored On-site


Encaps vitamin b6 33.3% 0.005 tonnes N/A

Italian dexloxiglumide 0.575 tonnes N/A

Itriglumide 0.008 tonnes N/A

Bromelain 2500 GDU 0.549 tonnes





Opalux AS22894 yellow 0.025 tonnes N/A

Andolast API 0.007 tonnes N/A

CR 3294.HCl 0.001 tonnes N/A

SCE-2487-1 0.07 tonnes N/A

Neutrapellets 30-35 1.475 tonnes N/A

Kollidon VA-64 0.113 tonnes N/A

Ethyl cellulose N.22 0.294 tonnes N/A

Sodium Fluoride 0.5 tonnes




Silica,colloidal anhydrous 0.1 tonnes N/A

Iron oxide (Colorant) 0.01 tonnes N/A

Peppermint Oil 0.02 tonnes N/A

Crospovidone 0.6 tonnes N/A

Vanillin 0.03 tonnes N/A

Citric Acid Anhydrous 6 tonnes N/A

Tripotassium citrate 15 tonnes N/A

Trisodium Citrate Dihydrate 12 tonnes N/A

Yellow Orange 3 tonnes N/A

For

insp

ectio

n pur

pose

s only

.

Conse

nt of

copy

right

owne

r req

uired

for a

ny ot

her u

se.

EPA Export 23-01-2016:01:05:22


IE0311736-22-RP-0003, Issue A 19/01/2016


Substance

Normal Quantity

Stored On-site


Lemon Oil 0.4 tonnes N/A

Castor Oil 1.2 tonnes N/A

Cholecalciferol (Vit. D3) 0.01 tonnes




H372: Causes damage to organs through prolonged or repeated exposure

Poloxamar 407 0.6 tonnes N/A

SMP (Sodium methyl parahydroxybenzoate

0.025 tonnes N/A

SPP (Sodium propyl parahydroxybenzoate)

0.025 tonnes N/A

Liquid Maltitol 2 tonnes N/A

COVIOX T70 0.02 tonnes N/A

Orange Caramel Aroma 0.05 tonnes N/A

Monopotassium Phosphate 0.05 tonnes N/A

Dossodium Phosphate Anhydrous

0.05 tonnes N/A

Benzoic Acid 0.050 tonnes N/A

Glycerol 0.2 tonnes N/A

Sweet Orange Essential Oil 0.6 tonnes N/A

Refined Olive Oil 4 tonnes N/A

Note 1: Hazard Classification as stated in EC Regulation 1272 / 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006

For

insp

ectio

n pur

pose

s only

.

Conse

nt of

copy

right

owne

r req

uired

for a

ny ot

her u

se.

EPA Export 23-01-2016:01:05:22


IE0311736-22-RP-0003, Issue A 19/01/2016


3 Stage 2: Identification of ‘Relevant Hazardous Substances’

The EC guidance states with respect to identifying relevant hazardous substances “...from the list produced in Stage 1, determine the potential pollution risk of each hazardous substance by considering its chemical and physical properties such as: composition, physical state (solid, liquid, and gas), solubility, toxicity, mobility, persistence, etc. This information should be used to determine whether or not the substance has the potential to cause pollution of soil and groundwater”.

3.1 Raw Materials

From the list provided in Stage 1 based on details provided by Rottapharm Ltd., the relevant hazardous substances, i.e. those which have the potential to cause soil and groundwater contamination have been identified. In order to determine the relevant hazardous substances, guidance has been taken from Table G.1 (ii) of the Industrial Emissions Licence application form which states:

“Relevant hazardous substances are those substances or mixtures defined within Article 3 of Regulation (EC) No 1272/2008 on the classification, labelling and packaging of substances and mixtures which, as a result of their hazardousness, mobility, persistence and biodegradability (as well as other characteristics), are capable of contaminating soil or groundwater.”

Table 3.1 below lists all materials stored on site which are defined as ‘Relevant Hazardous Substances’ along with the quantity of each substance that is normally stored on the Rottapharm Ltd. site.

Table 3.1: Relevant Hazardous Substances stored at Rottapharm Ltd.

Substance

Normal Quantity Stored On-site


Relevant Hazardous Substance

Note 2

Diesel 0.25 tonnes H351: Suspected of causing cancer Yes

Acetic acid 0.025 tonnes

H226: Flammable liquid and vapour


Yes

Acetone 3.3 tonnes




Yes

Acetonitrile hypergrade

0.088 tonnes


H332: Harmful if inhaled

H312: Harmful in contact with skin



Yes

For

insp

ectio

n pur

pose

s only

.

Conse

nt of

copy

right

owne

r req

uired

for a

ny ot

her u

se.

EPA Export 23-01-2016:01:05:22


IE0311736-22-RP-0003, Issue A 19/01/2016


Substance




Note 2

Bromelain (from pineapples)

0.86865 tonnes





Yes

Diethyl ether 0.006 tonnes

H224: Extremely flammable liquid and vapour



Yes

Ethanol absolute GR

0.8 tonnes H225: Highly flammable liquid and vapour

Yes

Eudragit 2.7 tonnes






Yes

Hydrochloric acid 0.005 tonnes



Yes

Hydrofluoric acid 40% GR ISO

0.005 tonnes


H310: Fatal in contact with skin

H300: Fatal if swallowed


Yes

Methanol 0.03 tonnes






Yes

For

insp

ectio

n pur

pose

s only

.

Conse

nt of

copy

right

owne

r req

uired

for a

ny ot

her u

se.

EPA Export 23-01-2016:01:05:22


IE0311736-22-RP-0003, Issue A 19/01/2016


Substance




Note 2



H318: Causes serious eye damage


Yes





Yes

Perchloric acid 0.021 tonnes

H271: May cause fire or explosion; strong oxidiser


Yes

Silver nitrate 0.005 tonnes


H400: Very toxic to aquatic life

H410: Very toxic to aquatic life with toxic effects

Yes

Sodium hydroxide 0.008 tonnes H314: Causes severe skin burns and eye damage

Yes

Bromelain 2500 GDU

0.549 tonnes





Yes

Sodium Fluoride 0.5 tonnes




Yes

Cholecalciferol (Vit. D3)

0.01 tonnes




H372: Causes damage to organs through prolonged or repeated exposure

Yes

For

insp

ectio

n pur

pose

s only

.

Conse

nt of

copy

right

owne

r req

uired

for a

ny ot

her u

se.

EPA Export 23-01-2016:01:05:22


IE0311736-22-RP-0003, Issue A 19/01/2016


Note 1: Hazard Classification as stated in EC Regulation 1272 / 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006

Note 2: Defined as a ‘Relevant Hazardous Substance’ in accordance with Article 3 of Regulation (EC) No 1272/2008

3.2 Hazardous Waste

All hazardous waste is labelled appropriately, stored in bunded stores with no pathway to soils and groundwater until removed from site by licensed waste contractors.

Waste vehicle batteries are stored in a designated bunded container in the warehouse. Small batteries are collected and stored in an allocated bunded battery bin in the Stores area.

Electronic equipment and waste fluorescent tubes and lamps are also collected and stored in allocated cages and bins in the Stores Area. All of these materials are removed from site for recycling by a licensed haulier and are recovered by a licensed waste contractor.

Grease is collected in barrels and stored on bunded pallets. Laboratory chemicals are stored in a suitable bunded container. These are removed from the site by a licensed waste haulier.

All wastes described above are transferred in accordance with local and European waste legislation.

As a result of the above storage and containment measures being implemented on the Rottapharm Ltd. site, waste materials are not included in Stage 2. For information, Table 3.2 contains details of hazardous waste generated on the Rottapharm Ltd. site, along with its EWC Code and the estimated quantities generated per month.

Table 3.2: Hazardous Waste Generated On-site

Waste Description EWC Code Quantity generated per month

(tonnes)

Other solvents and solvent mixtures 14 06 03 0.6

Solid waste containing dangerous substances

07 05 13 0.9

Absorbents, filter materials (including oil filters), wiping cloths, protective clothing contaminated by dangerous substances

15 02 02 0.5

Organic wastes containing dangerous substances

16 03 05 0.02

Laboratory chemicals containing dangerous substances

16 05 06 0.08

Chemicals consisting of or containing dangerous substances

18 01 06 0.001

Discarded electrical and electronic equipment

20 01 35 0.3

For

insp

ectio

n pur

pose

s only

.

Conse

nt of

copy

right

owne

r req

uired

for a

ny ot

her u

se.

EPA Export 23-01-2016:01:05:22


IE0311736-22-RP-0003, Issue A 19/01/2016


4 Stage 3: Assessment of Site-Specific Pollution Possibility

The EC guidance states that each relevant hazardous substance brought forward from Stage 2, should be considered in the context of the site to determine whether circumstances exist which may result in the release of the substance in sufficient quantities to represent a pollution risk, either as a result of a single emission or as a result of accumulation from multiple emissions. Specific issues to be considered include:

- The quantity of each hazardous substance handled, produced or emitted in relation to its environmental effects.

- The location of each hazardous substance on the site e.g. where it is or will be delivered, stored, used, moved around the site, emitted etc., in particular in view of the characteristics of the soil and groundwater underlying that part of the site.

- In case of existing installations: the presence and integrity of containment mechanisms, nature and condition of site surfacing, location of drains, services or other potential conduits for migration.

4.1 Quantities of Hazardous Substances

The quantities of all relevant hazardous substances stored at the Rottapharm Ltd. site are given in Table 3.1. It is considered that the quantities of relevant hazardous substances being stored on site are low, with the only relevant hazardous substances being stored in quantities greater than 1m

3 or

1 tonne are Acetone, Eudragit and 2-propanol.

Rottapharm Ltd. maintains a chemical inventory of all chemicals used on-site. Before a chemical is brought on-site, an approval form has to be completed and submitted with the MSDS for approval by EHS. Storage requirements are determined at that point. Once the chemical has been approved and risk assessment completed, the chemical is added to the chemical inventory.

4.2 Existing Conditions Underlying the Site

There is no soil or groundwater monitoring currently being carried out at the Rottapharm Ltd. site.

Prior to construction of the facility, an Environmental Impact Statement (EIS) was published in April 1998, and during the preparation of the EIS, a groundwater and soil quality investigation was carried out at the site. These investigations found that in general the site is underlain with topsoil and silty clays extending to depths ranging between 0.6m and 1.5m below ground level (bgl), which lay on top of brown gravelly clay which extend to depths ranging between 2.6m and 6.9m bgl. At 2 no. boreholes (one just to the north of the main Rottapharm Ltd. building and one just to the south of this building), silty organic clays were found to extend to a depth of 1.9m bgl, which was underlain by brown boulder clays extending to depths of 3m and 4.1m, respectively.

Site investigations were also carried out at the site in 2010 and 2011. These investigations found that the site is underlain by glacial till with alluvium being present in the southern portion of the site. This glacial till and alluvium was found to a depth of approximately 4.5 – 5m bgl. Gravels were observed at depth in the south-western portion of the site.

According to the Geological Survey of Ireland (GSI) online database1, the site is underlain by soils

derived mainly from mainly calcareous parent materials. This soil lies on top of a bedrock consisting of Marine Basinal Facies (Tobercolleen and Lucan Fms – “Calp”), dark-grey argillaceous and cherty limestone and shale.

Chemical analysis carried out on the soils as part of the sire specific investigations in 1998 concluded that they have low concentrations of sulphates and a near neutral pH.

1 Geological Survey of Ireland Online Database, www.gsi.ie

For

insp

ectio

n pur

pose

s only

.

Conse

nt of

copy

right

owne

r req

uired

for a

ny ot

her u

se.

EPA Export 23-01-2016:01:05:22

http://www.gsi.ie/


IE0311736-22-RP-0003, Issue A 19/01/2016


Groundwater was encountered in some of the boreholes that were drilled during the site specific investigations in 1998; however there was no chemical analysis carried out on this groundwater.

During the site specific investigations in 2010 and 2011, it was found that groundwater was generally not observed in the glacial till underlying the site, except in localised zones of higher permeability. The gravels encountered at depth in the south-western prrtion fo the site were observed to be water-bearing and are likely to be in hydraulic connection with the Pinkeen and/or Tolka Rivers.

Chemical analysis on groundwater samples taken concluded that water quality in both the up-gradient and down-gradient wells were good. There were marginal exceedences of interim guideline values (IGVs) observed in relation to chloride and potassium. None of the remaining analytical exceeded their respective IGVs.

According to the GSI online database, the aquifer underlying the site is classified as a Locally Important Aquifer – Bedrock which is Moderately Productive only in Local Zones which is considered to have a low vulnerability.

The site investigations carried out in 2011 concluded that the clay-dominated soils observed at the site provide an element of protection to groundwater at the site from potential releases to ground. There was also no indication that Rottapharm Ltd.’s operations have had an adverse impact on groundwater quality beneath the site.

4.3 Storage and Containment

4.3.1 Industrial Emissions Licence Conditions

The storage and containment of hazardous materials on site is governed by the conditions of Rottapharm Ltd.’s existing Industrial Emissions Licence (EPA Licence Reg. No. P0886-01). This licence specifies a number of relevant conditions which Rottapharm Ltd. complies with on an on-going basis as outlined in Tables 4.1 – 4.3.

Table 4.1: Conditions for Infrastructure and Operation at the Rottapharm Ltd. Site

Condition 3: Infrastructure and Operation

3.6 Tank, Container and Drum Storage Areas

3.6.1 All tank, container and drum storage areas shall be rendered impervious to the materials stored therein. Bunds shall be designed having regard to Agency guidelines ‘Storage and Transfer of Materials for Scheduled Activities’ (2004).

3.6.2 All tank and drum storage areas shall, as a minimum, be bunded, either locally or remotely, to a volume not less than the greater of the following:

(i) 110% of the capacity of the largest tank or drum within the bunded area; or

(ii) 25% of the total volume of substance that could be stored within the bunded area.

3.6.3 All drainage from bunded areas shall be treated as hazardous waste unless it can be demonstrated to be otherwise. All drainage from bunded areas shall be diverted for collection and safe disposal

3.6.4 All inlets, outlets, vent pipes, valves and gauges must be within the bunded area.

3.6.5 All tanks, containers and drums shall be labelled to clearly indicate their contents.

3.7 The licensee shall have in storage an adequate supply of containment booms and/or suitable absorbent material to contain and absorb any spillage at the installation. Once used, the absorbent material shall be disposed of at an appropriate facility

For

insp

ectio

n pur

pose

s only

.

Conse

nt of

copy

right

owne

r req

uired

for a

ny ot

her u

se.

EPA Export 23-01-2016:01:05:23


IE0311736-22-RP-0003, Issue A 19/01/2016


Condition 3: Infrastructure and Operation

3.8 Silt Traps and Oil Separators

The licensee shall install and maintain oil separators at the installation to ensure that all storm water discharges from the installation pass through an oil separator in advance of discharge. The separators shall be a Class I bypass separators and shall be in accordance with I.S. EN-858-2: 2003 (separator systems for light liquids).

3.9 Fire-water Retention

3.9.1 The licensee shall carry out a risk assessment to determine if the activity should have a fire-water retention facility. The licensee shall submit the assessment and a report to the Agency on the findings and recommendations of the assessment within six months of the date of grant of this licence.

3.9.2 In the event that a significant risk exists for the release of contaminated fire-water, the licensee shall, based on the findings of the risk assessment, prepare and implement, with the agreement of the Agency, a suitable risk management programme. The risk management programme shall be fully implemented within three months of date of notification by the Agency.

3.9.3 The licensee shall have regard to the Environmental Protection Agency Draft Guidance Note to Industry on the Requirements for Fire-Water Retention Facilities when implementing Conditions 3.9.1 and 3.9.2 above.

3.10 All pumps sumps, storage tanks, lagoons or other treatment plant chambers from which spillage of environmentally significant materials might occur in such quantities as are likely to breach local or remote containment or separators, shall be fitted with high liquid level alarms (or oil detectors as appropriate) within six months from the date of grant of this licence.

3.11 The provision of a catchment system to collect any leaks from flanges and valves of all overground pipes used to transport material other than water shall be examined. This shall be incorporated into a Schedule of Environmental Objectives and Targets set out in Condition 2 of this licence for the reduction in fugitive emissions.

3.12 Groundwater

3.12.1 The licensee shall, within twelve months of the date of grant of licence, install three groundwater monitoring points, one upgradient and two downgradient of the installation, at locations to be agreed by the Agency.

3.12.2 All wellheads shall be adequately protected and maintained to prevent contamination or physical damage, from the date of their installation

Table 4.2: Conditions for Control and Monitoring at the Rottapharm Ltd. Site

Condition 6: Control and Monitoring

6.6 The licensee shall ensure that groundwater monitoring well sampling equipment is available / installed on-site and is fit for purpose at all times. The sampling equipment shall be to Agency specifications.

6.10 The integrity and water tightness of all underground pipes, tanks, bunding structures and containers and their resistance to penetration by water or other materials carried or stored therein shall be tested and demonstrated by the licensee within twelve months of the date of grant of this licence. This testing shall be carried out by the licensee at least once every three years thereafter and reported to the Agency on each occasion. This testing shall be carried out in accordance with any guidance published by the Agency. A written record of all integrity tests and any maintenance or remedial work arising from them shall be maintained by the licensee.

For

insp

ectio

n pur

pose

s only

.

Conse

nt of

copy

right

owne

r req

uired

for a

ny ot

her u

se.

EPA Export 23-01-2016:01:05:23


IE0311736-22-RP-0003, Issue A 19/01/2016


Condition 6: Control and Monitoring

6.11 The drainage system (i.e., gullies, manholes, any visible drainage conduits and such other aspects as may be agreed) and bunds, silt traps and oil separators shall be inspected weekly and desludged as necessary. All sludge and drainage from these operations shall be collected for safe disposal. The drainage system, bunds, silt traps and oil interceptors shall be properly maintained at all times.

6.12 An Inspection for leaks on all flanges and valves on over-ground pipes used to transport materials other than water shall be carried out weekly. A log of such inspections shall be maintained.

6.13 Storm Water

A visual examination of the storm water discharges shall be carried out daily. A log of such inspections shall be maintained.

6.15 Ground Water

The licensee shall, if required by the Agency, arrange for the carrying out, by an appropriately qualified consultant / professional, of a comprehensive hydrogeological investigation of the site. The scope, detail and programme, including report structure and reporting schedule, for this investigation must be agreed by the Agency prior to implementation. Any recommendations arising from a report or reports on this investigation must be implemented within such a period to be agreed by the Agency.

Table 4.3: Conditions for Materials Handling at the Rottapharm Ltd. Site

Condition 8: Materials Handling

8.3 The licensee shall ensure that, in advance of transfer to another person, waste shall be classified, packaged and labelled in accordance with National, European and any other standards which are in force in relation to such labelling.

8.4 The loading and unloading of materials shall be carried out in designated areas protected against spillage and leachate run-off

8.5 Waste shall be stored in designated areas, protected as may be appropriate against spillage and leachate run-off. The waste shall be clearly labelled and appropriately segregated.

4.3.2 Rottapharm Ltd. Procedures and Controls

In addition to compliance with conditions of its Industrial Emissions Licence as outlined above, Rottapharm Ltd. has a number of relevant internal control procedures and policies in place. The storage and transfer of materials at the Rottapharm Ltd. site is carried out in accordance with the EPA guidance note “IPC Guidance Note on Storage and Transfer of Materials for Scheduled Activities, 2004”. It is noted also that there are no emissions to ground or groundwater, licensed or otherwise, from the Rottapharm Ltd. facility.

Before any new chemical can be introduced to site, an approval form has to be completed and submitted with the MSDS for approval by the Rottapharm Ltd. EHS Department, at which point any specific storage and containment requirements are determined. Once the chemical has been approved and risk assessment completed, the chemical is added to the Rottapharm Ltd. chemical inventory.

Raw materials are received in a variety of packages such as fibre board drums, cardboard boxes, stainless steel drums/IBCs, flexible IBCs and paper and plastic sacks. These are often stored in double lined containers.

Spill kits and emergency containment are provided where appropriate, with a trained Chemical Spill Team and dedicated emergency response procedure. The functions of the chemical spill team are contained in the emergency response procedure. This requires the spill team to attend the spill,

For

insp

ectio

n pur

pose

s only

.

Conse

nt of

copy

right

owne

r req

uired

for a

ny ot

her u

se.

EPA Export 23-01-2016:01:05:23


IE0311736-22-RP-0003, Issue A 19/01/2016


isolate and evacuate the spill area, determine substances and quantities involved and to report to the Engineering Manager/EHS Manager.

No substances, including hazardous chemicals and wastes, are stored outside of bunded/contained areas/stores. Bunds are provided at the following locations:

- Effluent treatment

- QC lab store

- Solvent stores

- Plant room

- Mobile bunds in various locations across the site

Bund inspection takes place on a regular basis to ensure that they are working correctly and that they will retain any spillage of chemicals which may occur. Bunds are tested every 3 years in accordance with the conditions of Rottapharm Ltd.’s Industrial Emissions Licence.

All chemical unloading areas have been designed such that any spills in the loading or unloading operation will drain to a collection point and will not cause contamination of the ground.

The warehouse has a number of chemical stores and bunds for the storage of chemicals before distribution to the rest of the site. All chemicals are stored within bunded areas, in accordance with EPA guidelines and the conditions of Rottapharm Ltd.’s Industrial Emissions Licence. Within laboratories, chemicals are stored inside contained chemical cabinets according to their compatibility. Staging areas for production chemicals are fully bunded rooms or in bunded pallets.

There are external solvent stores located to the rear of the warehouse building, which are used to hold fresh and waste 200 litre solvent drums and IBCs. Waste oils are also stored in this area. Very limited waste solvent transfer operations are also carried out in this area. Earthing clips are also in place, which are used during solvent transfer operations. As stated above, these solvent stores are bunded.

A firewater retention risk assessment has been carried out for the site and it concludes that the site is low risk due to the extensive firewater suppression measures provided on site as well as the low amount of hazardous material stored on site; therefore the potential for contaminating the surface/ground water system is low. Due to the site’s low fire water runoff risk it does not require dedicated firewater retention facilities to be provided.

Quarterly monitoring of pH and TOC monitoring on surface water discharges from the site is carried out as well as weekly visual inspections.

4.4 Conclusion

Based on the information provided in the previous sections of this report, it is apparent that due to the soil and groundwater underling the site, the quantities and types of substances used, produced or released, and the control and containment measures in place, the likelihood of potential contamination of soils and/or groundwater is low. Therefore in accordance with the EC guidance, progression to Stage 4 is not required.

For

insp

ectio

n pur

pose

s only

.

Conse

nt of

copy

right

owne

r req

uired

for a

ny ot

her u

se.

EPA Export 23-01-2016:01:05:23


IE0311736-22-RP-0003, Issue A 19/01/2016


5 Conclusion

As stated in the Guidance “Where during stages 1-3 it is demonstrated on the basis of the available information that a baseline report is not required, there is no need to progress to the later stages”.

Based on the information provided in the previous sections of this Baseline Report, it is apparent that due to the soil and groundwater underling the site, the quantities and types of substances used, produced or released, and the control and containment measures in place, the likelihood of potential contamination of soils and/or groundwater is low. Therefore in accordance with the EC guidance, progression to Stage 4 is not required.

The existing facility, as well as the proposed changes as part of this licence review, has been designed to ensure protection of soil and groundwater. All material handling will be undertaken within designated areas and accordingly there is a low risk of soil/groundwater pollution arising during operations. It is also noted that there are no discharges, licensed or otherwise, to ground or groundwater from the Rottapharm Ltd. facility.

For

insp

ectio

n pur

pose

s only

.

Conse

nt of

copy

right

owne

r req

uired

for a

ny ot

her u

se.

EPA Export 23-01-2016:01:05:23

baseline report in accordance with section 86b of …constructed above area 4. area 4 contains new...

Documents