UCB MANUFACTURING IRELAND LIMITED SHANNON FREE … · UCB Manufacturing Ireland Limited is member...

UCB Manufacturing Ireland Limited, Register no. P0020-02 AER 2014

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UCB MANUFACTURING IRELAND LIMITED

SHANNON FREE ZONE

SHANNON

CLARE

IE LICENSE REGISTER NO: P0020-02

ANNUAL ENVIRONMENTAL REPORT

2014

UCB Ltd, Register No.: P0020-02 AER 2014

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TABLE OF CONTENTS

1.0 Introduction ......................................................................................................... 4 1.1 Foreword ............................................................................................................... 4

1.2 Facility Information Summary .............................................................................. 4

1.3 Environmental Policy ............................................................................................ 6

1.4 Management Structures ........................................................................................ 7

2.0 Summary Information ........................................................................................ 9 2.1 Self-Monitoring Data ............................................................................................ 9

2.1.1 Emissions to Sewer ................................................................................ 9

2.1.2 Emissions to Storm Waters .................................................................. 11

2.1.3 Emissions to Groundwater ................................................................... 12

2.1.3.1 Bund and Pipeline Testing…………………………………..……….21

2.1.4 Emissions to Atmosphere .................................................................... 22

2.1.5 Waste Management .............................................................................. 25

2.2 Agency Monitoring & Enforcement ................................................................... 26

2.2.1 EPA site visit ....................................................................................... 26

2.3 Energy and Water Consumption ......................................................................... 27

2.3.1 Energy Consumption….......................................................................27

2.3.2 Water Consumption ............................................................................. 28

2.4 Environmental Incidents & Complaints ............................................................. 29

2.4.1 Complaints .......................................................................................... 29

2.4.2 Incidents .............................................................................................. 29

2.5 Copy of Electronic Summary Information ........................................................ 29

3.0 Management of the Activity ............................................................................ 30

3.1 EMP 2014 …………………………………………………………………… 31

3.2 EMP 2015……………………………………………………………………...36

3.3 Finance…...………………………………………………………………….…38

3.4 3rd

Party Audits………………………………………………………………...38

4.0 License Specific Reports……………………………………………………….38


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LIST OF TABLES

Table 1 Summary of Mass Emissions to Sewer ................................................ 10

Table 2 Summary of Toxicity Test Results ...................................................... 11

Table 3 Summary of Air Emission Monitored Parameters ............................... 22

Table 4 Summary of Emissions from VE155 ................................................... 22

Table 5 Summary of Emissions from VE135 ................................................... 23

Table 6 Summary of Non-compliances to Atmosphere .................................... 24

Table 7 Summary Information on Waste Arisings ........................................... 25

Table 8 Summary of EPA Visits ....................................................................... 26

Table 9 Summary of Energy Consumption Data .............................................. 27

Table 10 Summary of Water Consumption Data ................................................ 28

Table 11 Summary of Incidents Reported .......................................................... 29

LIST OF FIGURES

Figure 1 Environment, Health & Safety Policy ....................................................... 6

Figure 2 Company Organisational Structure ............................................................ 8

APPENDICES

1 – SMP Spreadsheet

2 - PRTR

3 – ELRA Financial Provision


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1.0 Introduction

1.1 Foreword

This report, covers the period from January 2014 to December 31, 2014 and has been

prepared in accordance with the EPA Guidance for Annual Environmental Report

(Version 2.0_Draft Jan 2014)) and other relevant updated guidance notes as provided

by the EPA on the agency website (www.epa.ie). The report format does not use the

proposed templates which as indicated by the Agency is not mandatory for 2014.

1.2 Facility Information Summary

Current IED Licence Number: P0020-02

Former IPC Licence Number: 729

NACE Code: 2120

National Grid Reference: -8.89779, 52.7098

Class of Activity:

5.16 The use of a chemical or biological

process for the production of basic

pharmaceutical products.

11.1 The recovery or disposal of waste in a

facility, within the meaning of the Act of

1996, which facility is connected or

associated with another activity

specified in this Schedule in respect of

which a licence or revised licence under

Part IV is in force or in respect of which

a licence under the said Part is or will be

required.

Issue Date: 20th

January, 2006

Licensee Address: UCB Manufacturing Ireland Limited

Shannon Free Zone

Shannon

Co. Clare

UCB Manufacturing Ireland Limited is a medium sized Bulk Pharmaceutical

Manufacturing facility located in the north-west corner of the Shannon Industrial

Estate adjacent to the Shannon International Airport approximately 1 kilometre from

the Shannon town centre. The site occupies approximately 17 acres and is physically

separated from the Airport by an open culvert which carries surface water from the

immediate catchment area to the Shannon River which is located approximately 4km

from the site. To the east the site is overlooked by the Westpark development.

Manufacturing operations commenced on site in 1982 and they have expanded over

the intervening years. The facility contains two Bulk Pharmaceutical synthesis

http://www.epa.ie/


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facilities known as SP1 and SP3 in which Synthetic Chemistry is undertaken to

produce Bulk Pharmaceutical Product. The site also contains a Pharmaceutical

Finishing Facility SP2 together with associated Laboratory, R & D, Administration,

Warehousing, Tank Farm, Pilot Plant, WWTP, TOU and other key utilities. UCB

Shannon also controls the marketing and intellectual property rights for other

Pharmaceutical Products not manufactured on site.

Production Area Products / Processes Product Indication

SP1 Multi Product Neurological

SP2 Nitrates Blending, Milling and

Bulk Packaging

Cardiovascular

SP3 Nitrates Synthesis (5-ISM and

ISDN)

Cardiovascular

UCB Manufacturing Ireland Limited is member of the UCB Group, UCB has its

headquarters in Brussels, Belgium and it is a leading Global Biopharmaceutical

organisation dedicated to the research, development and commercialisation of

innovative pharmaceutical and biotechnology products in the fields of central nervous

system disorders, allergy/respiratory diseases, immune and inflammatory disorders

and oncology. UCB employs approximately 9,000 people in over 37 countries and

recorded revenue of €3.462 billion in 2014. (http://www.ucb.com/about-

ucb/facts/sales) UCB is listed on the Euronext Brussels Exchange. UCB was recently

ranked in 76th

position in the Global 100 list ( ) of the world most sustainable

companies based on an evaluation of environmental, social and governance

performance indicators. UCB Manufacturing Ireland Limited was acquired by UCB in

2006.

In 2014 Operations continued in SP1, SP2 and SP3 manufacturing Cardiovascular

and Neurological API’s. Approximately 112 Tonnes of product was produced as

finished goods.

The site maintained a high level of compliance in 2014, there were no issues of

environmental significance or external complaints. All external audits were positive

and no Major or Minor non-compliances were reported. The site maintained its

program of continual improvement and a number of Environmental projects were

undertaken in the area of Energy reduction, Waste minimisation, Systems

improvement and compliance.

http://www.ucb.com/about-ucb/facts/sales

http://www.ucb.com/about-ucb/facts/sales


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1.3 Environmental Policy

Figure 1


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1.4 Management Structures

UCB Manufacturing Ireland Limited operates a structured approach to the

management of its operations. The site is led by the Managing Director and the Senior

Management Team and all departments are fully integrated. (See organisational

structure in Fig 2) The site operates a Right First Time and Continual Improvement

ethos.

The organisation operates a relatively flat management structure with a strong

emphasis on team work. The EHS Director reports directly to the Managing Director

and there also is a link with Corporate EHS within the UCB Organisation. There are

currently two Environmental Officers and an Environmental Technician all of whom

report directly to the EH&S Director. The EHS Team is supported by an

Administrator.

Safety, Environmental and Quality management systems are audited on an on-going

basis by a combination of both internal and external audit teams. UCB is accredited to

the Environmental Management System, ISO 14001.

The facility is classified as a Seveso Tier II site under the terms of the regulations.

The facility operates under licence from the FDA and IMB and the site is subject to

routine Regulatory and Customer Quality Audits. The site is also subject to routine

internal Auditing and a high level of on-going compliance has been maintained in

recent years. There is a strong EHS Culture in place on site.


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Figure 2 Companies Organisational Structure

Managing Director

HR Director Finance & SCM

Director /

SCM Manager

Technical Purchasing

Engineering Director

Facilities & Maint Mgr

Senior IT Support

EH&S Director

SP1

Manager

SP2 / SP3 Plant

Manager

QC & Technical

Support Director

Continuous Improvement

Engineer

QA&V Director

Admin. Assistant


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2.0 Summary Information

This section of the Annual Environmental report (AER) summarises all environmental

and resource monitoring information for the calendar year 2014.

Information on emissions and discharges to air and water are summarised as annual

mass emissions. Each section includes an evaluation of all non-compliances with the

conditions and schedules of the Industrial Emissions licence, together with a summary

of environmental incidents reported to the Agency during 2014.

Information on waste arisings are presented in the format of the AER electronic

spreadsheet as directed by the Agency.

Information relating to complaints and incidents are included in the relevant sections.

Full details on the incidents are available on ALDER. No external complaints were

received in 2014.

The Electronic Summary information relating to emissions, discharges, waste arisings

and resource use have been submitted to the Agency as required.

2.1 Self-Monitoring Data

The following sections provide summary details of UCB’s environmental monitoring

data for 2014.

2.1.1 Emissions to Sewer

An aerobic WWTP is in place on the UCB site which is utilised to affect the

biological treatment of aqueous waste arising from site manufacturing, utilities and

laboratory activities. Wastes which require treatment in the WWTP are screened for

toxins and tested for compatibility before introduction to the plant as per License

requirements.

Treated effluent arising from the WWTP is discharged into the industrial estate sewer

network and is subsequently transferred to the municipal waste water treatment plant.

24hr flow proportional samples of the final effluent are taken and tested in the

Environmental Laboratory to confirm compliance with license limits. Samples are

also taken at each step of the treatment process on a daily basis in order to ensure on-

going monitoring of the process and effective process control. The effective

monitoring of the process ensures the early identification of any changes in the

process that may arise and the prompt implementation of remedial actions where

necessary.

In 2014 the WWTP operated effectively and there were no notified Non-Compliances.


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Table 1 Summary of Mass Emissions to Sewer

MASS EMISSIONS TO SEWER YEAR ON YEAR

2012 2013 2014 License

limits Mass Limits

% change

Reason for Change % of Limit in

2014

Volume (m3)

31,369 33,212 30,862 180m³/d 65,700 -7.1% no significant change in volume of final effluent discharged, daily rate ~ 72 m3/d.

47.0%

pH 6-9 6-9 6 - 9 6 – 9 - no significant change

Temp(°C) <43 <43 <43 43 - no significant change

Toxicity (TU)

<3.1 <3.1 <3.1 10 - no significant change

COD (kgs) 2,867 3,551 15,711 10,000mg/l or 1,400 kg/d

511,000 342.4% Increase in COD due to the introduction of new waste streams from new processes being run in SP1. The impact is not significant.

3.1%

Sulphate (kgs)

2,494 2,426 1,448 1,000 mg/l

65,700 -40.3% The reason for the reduction in sulphate levels compared with 2013 is unclear. The impact is not significant.

2.2%

Nitrates (kgs)

60.7 83 41.5 200 mg/l 13,140 -50.0% A change to routing of SP3 waste has resulted in less nitric acid being used in reception tank B01

0.3%

Ammonia (kgs)

313 146 221 200 mg/l 13,140 51.4% Increase due to the introduction of an ammonia rich stream from new plant processes resulting in elevated concentrations in quarter 1 (within licence ELV)

1.7%

Phosphate (kgs)

4.4 3.5 2.4 n/a n/a -31.4% Reduction due to slightly lower P input over course of year.

Suspended Solids (kgs)

622 561 661 400 mg/l 26,280 17.8% Increase in TSS over the course of the year, no identified cause.

2.5%

Chloride (kgs)

61,158 49,396 42,676 5,000 mg/l

328,500 -13.6% Reduction in chloride over course of year, main sources being production effluent and pH neutralisations.

13.0%

Bromide (kgs)

231 169 197 2,200 mg/l

144,540 16.6% Increase in bromide, no changes to inputs over course of 2014, however detection limit did change and may be the sourec of the increase as many of the results were at or below LOD.

0.1%

Sulphide (kgs)

0.81 0.88 0.63 n/a n/a -28.4% Reduction in sulphide, no identified cause.

Oils, Fats & Grease (kgs)

16.5 17.63 17.12 n/a n/a -2.9% No significant change.

Alkalinity (kgs)

27,549 17,027 21,889 n/a n/a 28.6% Increase in alkalinity, no identified cause

Acetate (kgs)

12.79 0.18 84.00 n/a n/a 46566.7%

Most of data is less than detection limit, however average data skewed by a single high data point in June

BOD (kgs) 154.6 142.2 4027 n/a n/a 2731.9% Increase in BOD due to slower degrading component in new waste stream from Production

Copper (kgs)

0.642 1.736 0.13 0.5 mg/l 32.85 -92.5% Reductio due to lower range analytical method being used, with a lower limit of detection.

0.4%

Zinc (kgs) 2.34 2.75 3 0.5 mg/l 32.85 -4.4% No significant change 8.0%

Toluene 0.016 0.018 0.015 0.1mg/l 6.57 -16.7% No significant change. 0.2%

Xylene 0.016 0.018 0.015 -16.7% No significant change.

VOC 180.9 187.1 5.169 n/a n/a -97.2% Most of data is less than detection limit, however average data skewed by a single high data point inNovember


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Notes:

1 – When calculating the load for materials with analysis values of less than the limit of detection 50% of the limit of detection is taken in the mass emission calculation.

2 – For monthly data the annual load is calculated as the average of the daily data times 365. 3 – No data above the limit of detection exists. 4- There were no bypasses of the WWTP in 2014

Toxicity Testing

Schedule B.3, Emissions to Sewer of the Licence sets a limit of 10 toxic units; results

for 2014 were within the set license limits. City Analysts Limited in Shannon carried

out the required toxicity testing in 2014, continuing the same testing regime as

previous years.

Table 2 Summary of Toxicity Test Results

Test Parameter Conc

% vol.

/vol.

Toxic

Units

2011

Toxic

Units

2012

Toxic

Units

2013

Toxic

Units

2014

INDUSTRIAL

EMISSIONS

ELV Toxic

Units

48h LC50 to Tisbe battagliai > 32 <3.1 <3.1 <3.1 <3.1 10

72 h IC50 to Skeletonema

costatum > 32 <3.1 <3.1 <3.1 <3.1 10

30 min EC50 to Vibrio fischeri N/A <2.2 <2.2 <2.2 <2.2 10

2.1.2 Emissions to Surface waters

Surface water from the UCB site is discharged into the North West catchment, this is

a small open culvert which runs along the Northwest Boundary of the site and collects

all of the surface waters from the industrial estate. The site surface water is discharged

into the culvert via two monitored discharge points SW07 and SW44 that are located

at the northern and southern ends of the site.

All surface water leaving the site is continuously monitored for pH, TOC and Oil

film. In the event that the surface water is outside any of the set trigger limits the

discharge is automatically stopped and subsequently diverted to Fire Water Retention

tanks where it is held pending treatment in the WWTP or offsite disposal.

There were no Licence Non-Compliances in 2014 relating to emissions to Surface

Water. Trigger limits were exceed on three occasions in 2014 in which notifications

were made to the agency. See Section 2.4.2 for full details of the incidents. There

were no offsite effects relating to any of these events. Surface water monitoring data

is included in submitted monthly reports.


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2.1.3 Emissions to Groundwater

Groundwater monitoring is carried out on site as per license requirements and Agency

request. There are seven licensed boreholes on site namely GS01, GSO2, GSO3,

GS04, GS06, GS11 and GS12. These are monitored on a biannual basis as per license

requirements.

In 2014 Groundwater samples were analysed by City Analysts Laboratories for

organics, major anions, major cations and heavy metals. In-house testing was

undertaken for Ammonia, Nitrate, pH, conductivity and some anions/cations.

The results for the Bi-Annual licensed groundwater well samples undertaken in 2014

are on file in UCB and are available to view as required.

A summary status of each of the licensed wells is provided below:

1. GS01

a. No solvents were detected in GS01 in 2014.

b. DRO & PRO were both less than detection limits for these parameters

from monitoring carried out in 2014.

c. pH results for the June and November 2014 monitoring rounds were

7.22 and 7.15 respectively. Conductivity results for the June and

November 2014 monitoring rounds were 1252µS/cm and 1219µS/cm

respectively. The Groundwater Regulations 2010 threshold value for

conductivity that provides an ‘assessment for the presence of saline

intrusion or other intrusions’ is 800µS/cm. The location of the site

close to the Shannon estuary could account for possible saline intrusion

and the above mentioned conductivity values.

d. Trends for Magnesium, Sodium, Nitrate as N, Fluoride, Bromide and

Sulphide have been in general similar to previous year’s trends and are

below the guideline values and are not considered significant.

e. Results for Alkalinity as HCO3 and CaCO3 were similar to monitoring

results in previous few years. No guidelines values are available for

Alkalinity but results were on average 293mg/l in 2014.

f. A slight increase on Nitrate values was observed in 2014 over 2013

monitoring results but they are well within guideline values. Results

are not considered significant.

g. Trends for Sulphate, Phosphate and Potassium have in general

remained on par with previous monitoring rounds from previous years

and are outside the guideline values. The Groundwater Regulations

2010 threshold values/ EPA IGV guideline values for Sulphate,

Phosphate and Potassium are 187.5mg/l, 0.03mg/l and 5.0mg/l

respectively. Average results obtained from 2014 monitoring for

Sulphate, Phosphate and Potassium were 326mg/l, 0.62mg/l and

8.6mg/l respectively. Trends maybe due to local variations and are not

considered significant. Calcium was recorded at a level of 168mg/l in

November 2014. This result was within the guideline value and is the

lowest value recorded for all monitoring events since June 2010.


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h. The result for Ammonia as N in June 2014 monitoring had increased

from the 2013 montoring result and was outside the guideline value.

The result obtained was 746ug/l. The Groundwater Regulations 2010

guideline threshold value for Ammonia as N is 65ug/l (0.065mg/l).

This result obtained may have been due to local variations in the area

of groundwater well GS01. The November 2014 result was well within

the guideline value and was similar monitoring rounds in previous

years.

i. The trend for Chloride in 2014 had shown a slight increase from 2013

levels and was outside the threshold value for Chloride. This maybe

due to local variations and saline intrusion. The average result obtained

in 2014 was 47mg/l. The Groundwater Regulations 2010 threshold

value for Chloride is 24mg/l. Overall the results are not considered

significant.

j. The result for Nitrite from the 2014 monitoring of GS01 were within

the Groundwater Regulations 2010 threshold values.

k. Results for Manganese, Iron, Aluminium and Arsenic are slightly

lower or similar to previous year’s results and are within guideline

values. Results are not considered significant.

l. Results for Barium and Cadmium for 2014 are similar to previous

years’ monitoring for these metals. Results are well within EPA IGV/

Groundwater Regulations 2010 threshold values but when compared to

the tighter Dutch Target values of 50ug/l and 0.4ug/l the result for

Barium is slightly outside the target value. The average results for

Barium and Cadmium for 2014 were 73.5ug/l and 0.4ug/l. The results

are not considered significant and maybe due to local variations in the

area.

m. Results for Chromium, Nickel, Zinc, Boron, Antimony, Cobalt, Silver,

Arsenic, Mercury, Lead, Selenium and Beryllium are all comparable

with previous years’ monitoring results. Chromium and Nickel have

shown a slight upward trend with Zinc showing a slightly downward

trend from monitoring results in previous years. Overall results are not

considered significant.

2. GS02


b. DRO’s were detected at a level of 90.9µg/l in June 2014. No PRO’s

were detected in June. DRO’s & PRO’s were both less than detection

limits in November 2014.



November 2014 were 1337µS/cm and 1025µS/cm respectively. The

Groundwater Regulations 2010 threshold value for conductivity that

provides an ‘assessment for the presence of saline intrusion or other


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intrusions’ is 800µS/cm. The location of the site close to the Shannon

estuary could account for possible saline intrusion and the above

mentioned conductivity values.

d. 2014 results for Magnesium, Nitrate as N and Bromide have in general

been similar to previous year’s trends and are below the guideline


e. There was no Nitrate detected in GS02 in 2014.

f. The results for Potassium for 2014 were outside the EPA I/GV of

5.0mg/l. The results obtained for Potassium in 2014 were 21.2mg/l and

17.3mg/l respectively. The results for Chloride for 2014 were outside

the Groundwater 2010 Regulation threshold value for Chloride. The

threshold value for Chloride is 24mg/l. The results obtained for

Chloride in 2014 were 66.4 mg/l and 50.1mg/l respectively. The results

obtained for Phosphate were outside the EPA IGV of 0.03mg/l. The

Phosphate results for 2014 were 5.69mg/l and 1.33mg/l respectively.

The results for Nitrite were within the Groundwater Regulations 2010

threshold value of 0.375mg/l. The results for Chloride, Potassium ,

Nitrite and Phosphate are most likely due to a naturally occurring

cause, possibly due to saline intrusion, and local to the area. The result

for Sodium has shown a reduction in November 2014 in comparison to

previous results. Results are not considered significant.

g. Results for Alkalinity were in general variable compared to previous

years monitoring. No guidelines values are available for Alkalinity. An

average result for 2014 for GS02 was 570mg/l.

h. Trends for Ammonia as N in 2014 were similar to previous years and

were outside the guideline values. The Groundwater Regulations 2010

threshold value for Ammonia as N is 65ug/l (0.065mg/l). Results

obtained for 2014 were 0.746mg/l and 0.038mg/l respectively and are

most likely due to a naturally occurring cause. Results are not


i. Results for Calcium and Sulphide for 2014 were similar to previous

years. Results for Calcium were significantly less than the guideline

values. Results for Sulphate in November 2014 monitoring were less

than the guideline values.

j. Results for Manganese were outside the EPA IGV of 50ug/l. The

results from monitoring in June and November 2014 were 1250µg/l

and 1150µg/l respectively. Variations are possibly due to a naturally

occurring cause and local to the area.

k. Results for Aluminium and Chromium in the 2014 monitoring were

within the guideline values.


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l. Monitoring results for Nickel, Zinc, Antimony, Cobalt, Tin, Copper,

Cadmium, Lead, Arsenic, Selenium and Beryllium were in general

slightly lower than previous years and within guideline values.

3. GS03


b. DRO’s were detected at a level of 49.2µg/l in June 2014. No PRO’s

were detected in this monitoring round. DRO’s & PRO’s were both

less than detection limits in November 2014.









d. Trends for Calcium, Magnesium and Bromide are in general similar to

previous years and are within guideline values. Results are not


e. Trends for Ammonia as N were variable in the 2014 monitoring. The

result for June and November 2014 monitoring was 1.173mg/l and

0.139mg/l respectively and were outside the threshold guideline value.

The Groundwater 2010 Regulations threshold value for Ammonia as N

is 65ug/l (0.065mg/l). The results obtained from the 2014 monitoring

maybe due to naturally occurring cause and local to the area and are

not considered significant.

f. The results for NO3-N from the 2014 monitoring were within

guideline values and are not considered significant.

g. Trends for Nitrite, Fluoride and Sulphate from 2014 monitoring are

within the EPA IGV and/ or Groundwater 2010 Regulations threshold

values. Results for PO43-

are 0.45mg/l and 0.28mg/l respectively and

are slightly outside the EPA IGV of 0.03mg/l. Results are not


h. Trends for Potassium and Chloride have decreased over previous

years’ results but they remain outside their respective guideline values.

This may be due to a naturally occurring cause, possibly saline

intrusion, and local to the area for these particular parameters. Results

obtained for Potassium from 2014 monitoring are 11.8mg/l and

7.0mg/l respectively. The EPA IGV for Potassium is 5.0mg/l. Results

for Chloride for the 2014 monitoring were 25.9mg/l and 37.6mg/l

respectively. The Groundwater 2010 Regulations threshold guideline

value for Chloride is 24mg/l. This threshold value is for the assessment


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of the presence of saline intrusion. As mentioned the results obtained

may possibly be due to saline intrusion.

i. Results for Sodium have decreased when compared with previous

years’ results. There is no apparent reason for this and maybe due to a

naturally occurring cause. The Groundwater 2010 Regulations

threshold value for Sodium is 150ug/l. Sodium results obtained from

2014 monitoring were 204mg/l and 39mg/l respectively. The results

are not considered significant.

j. Results for Manganese, Iron, Silver and Aluminium from 2014

monitoring are within guideline values and are not considered

significant.

k. Results for Zinc, Boron, Cadmium, Lead and Copper have shown a

decrease in trends over previous years and are within guideline values.

Results are not considered significant.

4. GS04


b. DRO’s was detected at levels of 749µg/l in June 2014 and <50µg/l in

November. No PRO’s were detected in the 2014 sampling rounds.









d. Trends for Calcium, Magnesium, Sodium, Nitrate as N, Nitrate,

Fluoride, Bromide and Sulphide have in general been similar to

previous year’s results and are less than their respective guideline


e. Trends for Potassium, Chloride, Nitrite and Phosphate are similar to

previous monitoring rounds and are outside their respective guideline

values. Results obtained for Potassium from 2014 monitoring were

12.9mg/l and 13.0mg/l respectively. The EPA IGV for Potassium is

5.0mg/l. Results for Chloride from the 2014 monitoring were

114.9mg/l and 81mg/l respectively. The Groundwater 2010

Regulations threshold guideline value for Chloride is 24mg/l. This

threshold value is for the assessment of the presence of saline

intrusion. As with other wells on the UCB site the high values are most

likely related to a naturally occurring cause and possible due to saline

intrusion.


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f. Results for Alkalinity as HCO3 and CaCO3 were slightly higher than

previous years. The November 2014 result for Alkalinity as HCO3 was

511mg/l compared with 309mg/l in June 2014 and 349mg/l in 2013.

g. Results for Ammonia as N in 2014 were on average similar to previous

years and were outside the guideline values. Results obtained for 2014

for Ammonia as N were 2.15mg/l and 1.80mg/l respectively. The

Groundwater 2010 Regulations threshold value for Ammonia as N is

65ug/l (0.065mg/l). Results are most likely due to a naturally occurring

cause and are not considered significant.

h. The results for Sulphate were variable in 2014 but were in general

similar to previous years. Results obtained were within guideline

values.

i. Trends for metal results were similar to previous years and inside their

respective guideline values. Two exceptions occurred in relation to

Manganese and Antimony as they were outside their respective

guideline values for at least one monitoring round carried out in 2014.

The result obtained for Manganese in November 2014 was 237ug/l.

The EPA IGV for Manganese is 50ug/l. The result obtained for

Antimony in June 2014 was 0.65ug/l. The Dutch Target value for

Antimony is 0.15ug/l. Again these elevated results maybe due to a

naturally occurring cause and local to the area.

5. GS06

a. Similar to previous years monitoring no solvents were detected at

GS06 in 2014 monitoring.

b. DRO & PRO values were less than detection limits in 2014.









d. Trends for Magnesium, Sodium, Nitrate as N, Fluoride, Bromide,

Nitrite and Sulphide were in general similar to previous years and are

below guideline values.

e. Results for Alkalinity as HCO3 and CaCO3 were slightly higher in the

November 2014 when compared with previous years but the difference

is not considered significant.

f. Nitrate or NO3- N was not detected in November 2014 monitoring. A

result of 1.3mg/l NO3- N and 5.76mg/l NO3 was detected in the June

2014 monitoring. These results are within the guideline values.


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g. Trends for Calcium, Potassium, Chloride, Phosphate and Sulphate

were similar to previous years and are outside their respective

guideline values. This may be due to a naturally occurring cause,

possibly saline intrusion, and local to the area for these particular

parameters. The result obtained for Calcium from November 2014

monitoring was 230mg/l. The EPA IGV for Calcium is 200mg/l.

Results obtained for Potassium from 2014 monitoring were 5.6mg/l

and 6.9mg/l respectively. The EPA IGV for Potassium is 5.0mg/l.

Results for Chloride for the 2014 monitoring were 64.2mg/l and

49mg/l respectively. The Groundwater 2010 Regulations threshold

value for Chloride is 24mg/l. The threshold value for Chloride is for

the assessment of the presence of saline intrusion. As mentioned the

results obtained may possibly be due to saline intrusion and results are



are outside the guideline values. The results obtained were 2.15mg/l

and 1.80mg/l respectively.The Groundwater 2010 Regulations

threshold value for Ammonia as N is 65ug/l (0.065mg/l). This

threshold value provides an assessment of adverse impacts of chemical

inputs from groundwater on associated surface water bodies. Results

are most likely due to a naturally occurring cause and are not


i. Trends for metal results for GS06 in 2014 were similar to previous

years and were inside their respective guideline values. There were two

exceptions in 2014 namely Manganese and Antimony as the results for

these metals similar to previous years’ were outside their respective

guideline values. The EPA IGV for Manganese is 50ug/l. The results

obtained in 2014 were 323ug/l and 324ug/l respectively. The Dutch

Target value for Antimony is 0.15ug/l. The results obtained for

Antimony from the 2014 monitoring were 0.76ug/l and 1.79ug/l

respectively. As with other wells on the UCB site the values obtained

for Manganese and Antimony are most likely related to a naturally

occurring cause in the area and are not considered significant.

6. GS11


b. DRO’s and PRO’s were at levels less than detection in 2014.










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d. Trends for Calcium, Magnesium, Sodium, Fluoride, Bromide, Sulphate

and Nitrite were similar to previous years’ and are below the guideline

values for these parameters. Results are not considered significant.

e. Results of 8.2mg/l NO3 as N and 36.33mg/l NO3 were detected in the

June 2014 monitoring. These are less than the guideline values. No

NO3 or NO3- N was detected in the November monitoring in 2014.

f. Results for Alkalinity as HCO3 and CaCO3 were slightly higher in

November 2014 in comparison to previous years but the difference is


g. Trends for Potassium, Phosphate and Chloride are similar to previous

years and were outside their respective guideline values. The results

obtained for Potassium from 2014 monitoring were 13.7mg/l and

16.9mg/l respectively. The EPA IGV for Potassium is 5.0mg/l. Results

obtained for Phosphate from 2014 monitoring were 1.23mg/l and

0.55mg/l respectively. The EPA IGV for Phosphate is 0.03mg/l.

Results for Chloride for the 2014 monitoring were 83.2mg/l and

70.9mg/l respectively. The threshold value for Chloride is 24mg/l. The

threshold value for Chloride is for the assessment of the presence of

saline intrusion. The results obtained may possibly be due to saline

intrusion and local to the area for these parameters and are not



were outside the guideline values. The results obtained from 2014

monitoring were 1.572mg/l and 0.748mg/l respectively.The

Groundwater 2010 Regulations threshold value for Ammonia as N is

65ug/l (0.065mg/l). This threshold value provides an assessment of

adverse impacts of chemical inputs from groundwater on associated

surface water bodies. Results are most likely due to a naturally

occurring cause and are not considered significant.

i. Trends for metal results for GS11 in 2014 were similar to previous

years and were inside their respective guideline values. Results for

Manganese, Antimony, Chromium and Cadmium were similar to

previous years’ and were in general outside their respective guideline

values. The EPA IGV for Manganese is 50ug/l. The results obtained in

2014 for Manganese were 397ug/l and 314ug/l respectively. The Dutch

Target value for Antimony is 0.15ug/l. The results obtained for

Antimony from the 2014 monitoring were 0.17ug/l and 0.37ug/l

respectively. The Dutch Target value for Chromium is 1ug/l. A result

obtained in the 2014 monitoring was 4ug/l. The Dutch Target value for

Cadmium is 0.4ug/l. A result obtained in the 2014 was 0.5ug/l and was

just outside the target value. As with other wells on the UCB site the

values obtained for the above mentioned metals are most likely related

to a naturally occurring cause in the area and are not considered

significant.


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7. GS12


b. DRO’s and PRO’s were both less than detection limits in 2014.









d. Trends for Magnesium, Sodium, Nitrate as N, Fluoride, Bromide,

Sulphate and Sulphide were similar to previous year’s trends and are

below the guideline values.

e. No Nitrate ( NO3- N) was detected in the monitoring in 2014.

f. Trends for Ammonia as N in 2014 were similar to previous years and

were inside the guideline values. There was one exception in June

2014 where the monitoring result for Ammonia as N was 0.267mg/l.

The Groundwater 2010 Regulations threshold value for Ammonia as N

is 65ug/l (0.065mg/l). Similar to other wells on site this maybe due to a

naturally occurring cause and local to the area. The result is not


g. Results for Alkalinity in 2014 similar to previous years were variable

and were in the range of 278mg/l and 592mg/l. The levels are not


h. Trends for Calcium, Potassium, Chloride and Phosphate for 2014 are

similar to previous years and are outside their respective guideline

values. This may be due to a naturally occurring cause and local to the

area for these parameters. The result obtained for Calcium from

November 2014 monitoring was 231mg/l. The EPA IGV for Calcium

is 200mg/l. Results obtained for Potassium from 2014 monitoring were

6.0mg/l and 8.6mg/l respectively. The EPA IGV for Potassium is

5.0mg/l. Chloride levels in 2014 have increased very slightly compared

to monitoring in previous years and Chloride results for 2014 were

34.6mg/l and 33.2mg/l respectively. The Groundwater 2010

Regulations threshold value for Chloride is 24mg/l. The threshold

value for Chloride is for the assessment of the presence of saline

intrusion. The results obtained may have been possibly due to saline

intrusion. Results obtained for P043-

from 2014 monitoring were

1.4mg/l and 0.44mg/l respectively. The EPA IGV for Phosphate is

0.03mg/l. Results in general are not considered significant.


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i. Trends for metal results were similar to previous years and inside their

respective guideline values. Results for Manganese, Chromium,

Barium and Antimony were outside their guideline values. As

mentioned for some other wells the EPA IGV for Manganese is 50ug/l.

The results obtained in November 2014 for GS12 for Manganese was

86ug/l. The Dutch Target value for Antimony is 0.15ug/l. The results

obtained for Antimony from the 2014 monitoring were 0.29ug/l and

1.14ug/l respectively. The Dutch Target value for Chromium is 1ug/l.

A result obtained in the November 2014 monitoring was 4ug/l. The

Dutch Target value for Barium 50ug/l. Results obtained in the 2014

monitoring 63ug/l and 83ug/l and were slightly outside the target

value. As with other wells on the UCB site the values obtained for the

above mentioned metals are most likely related to a naturally occurring

cause in the area and are not considered significant.

There were no spillages recorded in the vicinity of any of the Groundwater

wells in 2014.

2.1.3.1 Bund / Tank / Pipeline Integrity Testing

Full records of all bund /tank/ and pipeline integrity testing are maintained on site as

per license requirements. There were no new bund introductions in 2014. All bunds

were checked as per the required frequencies in 2014. Two bunds were identified in

late 2013 which required repair and these were completed in Q1 of 2014. All Foul,

Process and Surface Water lines have been tested as per the required frequencies.

Hydraulic Testing was under taken on all lines which fell under the testing schedule

these included the Surface Water and Process networks. Identified defects were

repaired in Q1 2014.


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2.1.4 Emissions to Atmosphere

There are two licensed Atmospheric Emission points on site. VE155 is the reference

for the Thermal Oxidiser Unit (TOU). The TOU treats vent emissions from SP1 and

SP3. VE135 is the reference for the emission point on the SP2 Torit Dust Abatement

Unit. Table 3 below summarises the parameters which are monitored in the

aforementioned emission points.

Table 3 Summary of Monitored Parameters

Location Emission Point Parameters Measured

Main Site Thermal Oxidiser (VE-155) TOC, NOx, HCL, SO2, Cd, TI, Hg, Sb, As, Pb,

Cr, Co, Cu, Mn, Ni, V, CO, Dioxins, Flow

Main Site Pharma (VE-135) Particulates, Flow

Sampling was carried out for all licensed parameters at licensed emission points as

specified by Schedule B1 & C1.2 and Technical Amendment B. Tables 4 and 5 below

outline the total mass emissions from VE155 and VE135 respectively. While minor

variations in emission values relating to some parameters were recorded the reasons

for such variations are not known and they are not of environmental significance.

Table 4 Summary of Emissions from VE155


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Note:

There were 28 TOU downtimes in 2014, 3 of which were planned and 25 unplanned. The

unplanned Shutdowns were primarily related to Power outages/ power dips which were

beyond the control of the site. The remain issues included a low water level in the

scrubber and an issue with the safety PLC on the TOU. Where TOU shutdowns were

initiated the SP3 facility was shut down in less than 30 minutes as per agreement with the

Agency. Records of all shut downs are held on site for Agency inspection as required.

Site Fugitive emissions are detailed in the PRTR Report summary. The fugitive

emissions are estimates that are based on a Fugitive Emissions study carried by AECOM

Consultants. The emissions for CO are based on measured CO emissions from the on-site

CEMS monitoring and also on estimates from boiler emission reports that are carried out

by Geoff Castles Boiler Services Ltd.

Table 5 Summary of Emissions from VE135


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Table 6 – Summary of Non-Compliances to Atmosphere

There were two Non-Complainces relating to Atmospheric emissions in 2014.


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2.1.5 Waste Management

The national waste database table, providing a summary of waste arisings at the UCB

facility has been compiled for the calendar year 2014. This information is tabulated in

Table 7 below. There were no significant changes in waste arisings in 2014.

Table 7 Summary Information on Waste Arising’s


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2.2 Agency Monitoring & Enforcement

2.2.1 EPA site visits

The EPA undertook 3 sampling visits and 1 Audit/Inspection in 2014. The

sampling visits were undertaken as outlined in Table 8 below. A site Inspection

was undertaken by Niamh O’Donoghue in May 2014 as part of the routine

Annual Inspection. Observations were made in the audit and corrective actions

were raised to address the observations. All actions relating to the Inspection

were closed out as per the agreed timelines and communicated to the Agency

via ALDER.

Table 8

Date Type of Visit Emission

Points

Ref

Sample

Type Results within

specification Significant

Deviation

with EPA

Results 13/02/2014 Unannounced

visit

ES02 Effluent Yes No

13/02/2014 Unannounced

visit

SW44 Surface

Water

Yes No

20/03/2014 Unannounced

visit

Audit /

inspection

N/A N/A N/A

21/08/2014 Announced visit VE155 Air Yes No


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2.3 Energy and Water Consumption

2.3.1 Energy Consumption

Energy needs on site are satisfied using oil, electricity and gas. Steam requirements

for the processes are generated using two high efficiency steam boilers which have a

capacity of 5 Tonnes. Oil usage on site saw a significant reduction in 2010 due to

switch over to the usage of gas in the boilers. Gas usage has remained steady despite

increased activity in recent years and this has been due to ongoing energy projects

which have focused on increasing the efficiency of energy usage. Significant

projects in 2014 including the installation of a high efficiency gas boilers and

energy reduction projects associated with HVAC and Heating Turn down. Electrity

usage has also remained steady and again projects aimed at controlling energy usage

such as the turn down of Building HVAC units have had a significant impact on

usage. A cross functional Resource Management Group is in place on site which

focuses on projects associated with the optimisation of resource usage. Details of

related projects are included in the EMP.

Table 9 Summary Energy Consumption Data


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2.3.2 Water Consumption

UCB is supplied with potable water by Clare Co. Council for process and domestic

uses. Water is supplied through two public mains lines, which enter the plant at the

western perimeter and the security gatehouse. Infrastructure is in place which

provides an accurate and real time overview of water usage on site thereby

facilitating the effective and timely management of water usage on site. 2014 usage

saw an increase in consumption which was primarily associated with leaks in the

network which have since been identified and repaired. Some of the increase in

consumption is also attributed to increased activity levels in SP1. Surface water

continued to be harvested where possible in 2014 in order to minimise potable water

consumption.

Table 10 Summary Water Consumption Data


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2.4 Environmental Incidents & Complaints

2.4.1 Complaints

UCB received no complaints in 2014.

2.4.2 Incidents

The following ten incidents were reported to the Agency in 2014, two of which were

elevated to Non-Compliances to Atmosphere as outlined in section 2.1.4.

Table 11 Summary of Incidents

2.5 Copy of Electronic Summary Information

A copy of the electronic summary information has been compiled and uploaded onto the

EPA website as required under the PRTR regulations. A copy of the return is also

provided in Appendix 2.


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3.0 Management of the Activity

Section 3.0 of the AER provides details of the 2015 Environmental Management Programme (EMP), together with a review of the Objectives,

Targets and Plans completion for 2014. The 2015 EMP is also presented within the scope of this document for Agency approval.

The EMP and Schedule of Objectives and Targets fall under the sites ISO14001 Environmental Management System and accordingly are

included within a structured system of Management Review and periodic Auditing by both internal auditors and external certification body

(SGS). The UCB Environmental Management Programme (EMP) is a continuously updated plan which provides detail of the status of key

Environmental Improvement Programmes.

The Objectives and Targets outlined in the EMP are the key drivers of continual EHS performance improvement at UCB Manufacturing Ireland

Limited. They also serve to reduce Environmental Risk and reduce the company’s impact on the environment.


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3.1 Environmental Management Programme

3.1.1 Update on 2014 Programme

Objectives, Targets and Plans as outlined below were addressed in 2014 and 78% of the Plans set out for completion in 2014 were

completed. All incomplete items were carried forward into the 2014 EMP where appropriate.

3 key objectives were set in the 2014 programme.


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3.1.2 Proposed Program for 2015


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3.3 Finance

3.3.1 Expenditure

As an organisation UCB Manufacturing Ireland Limited – Member of the

UCB Group is committed to providing all of the necessary resources and

expertise to the environmental sustainability and compliance of the on-

site activities.

In 2014 approximately €600k was spent on Environment related capital

spending

3.3.2 ELRA and RMP

A Residual Management Plan and Environmental Liabilities Risk

Assessments are in place for the facility. Both documents were submitted

to the Agency in 2009 and remain valid as there have been no significant

changes to the facility since their completion. An updated copy of the

financial provision was also provided to the Agency in 2012. (See

Appendix 3. A review of the ELRA and RMP will be completed in 2015

and submitted to the Agency as necessary.

3.4 Third Party Inspections

An ISO14001 Recertification Audit was undertaken by SGS in March

2014. Continued certification was recommended. There were no Non-

Conformances issued during the Audit and some minor recommendations

were made. The site was also inspected by the H.S.A in 2014 again some

minor observations were made which have since been closed out.

4.0 License Specific Reports The Annual Noise and Odour Reports have been uploaded onto ALDER as

required. The Solvent Management spreadsheet is provided below in Appendix 1.

Waste Records completed as part of the PRTR are included in Appendix 2.


APPENDIX 1

SMP for 2014


APPENDIX 2


APPENDIX 3

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