annual environmental report for 2016 · environmental management programme – proposal appendix 3...

Astellas Ireland Co. Ltd. IPPC Licence P0007-03

All the data and information presented in this report has been checked and

certified as being accurate. The quality of the information is assured to meet

licence requirements.

Completed by: Date: 29/03/2017

Reviewed by: Date: 29/03/2017

Annual Environmental Report for 2016


1. INTRODUCTION This is the fifteenth annual environmental report submitted by Astellas Ireland Co., Ltd.

(Dublin) to the Environmental Protection Agency as a requirement of Condition

2.2.2.3 and Condition 11.9 of IE Licence P0007-03. This report details environmental

performance at the Astellas Ireland Dublin site for the calendar year 2016 in line with

the AER template issued by the EPA in January 2017.

Register No. P0007-03

Company Name: Astellas Ireland Co. Ltd.

Damastown Rd,

Damastown Industrial Park,

Mulhuddart,

Dublin 15.

Required Submission Date: 31st March


2. SUMMARY INFORMATION The information required to be reported in the AER as per Schedule D Annual Environmental

Report of IE Licence P0007-03 is included in the attached AER Template and specific

appendices – details of the information included in the AER is summerised below:

Emissions from the installation Appendix 1 - AER Template

Waste Management Record Appendix 5 - PRTR printed sheets

Analysis of waste for incineration report Appendix 2 – Composition of Waste

incinerated on-site 2016

Resource consumption summary Appendix 1 - AER Template

Complaints summary Appendix 1 - AER Template

Schedule of Environmental Objectives and Targets Appendix 1 - AER Template

Environmental Management Programme – proposal Appendix 3 – Environmental

Management Programme Report 2016

Environmental Management Programme – report Appendix 3 – Environmental

Management Programme Report 2016

Pollution Emission Register – proposal Appendix 4 – PRTR Report 2016

Pollution Emission Register – report for 2015 Appendix 4 – PRTR Report 2016

Groundwater Monitoring summary Appendix 1 - AER Template

Underground pipe inspection report Appendix 1 - AER Template

Bund Testing report Appendix 1 - AER Template

Noise report Appendix 1 - AER Template

Monthly monitoring reports Appendix 1 - AER Template

Energy efficiency audit report summary Appendix 1 - AER Template

Report on the assessment of the efficiency of use of

raw materials in processes and the reduction in waste

generated

Appendix 1 - AER Template

Environmental Liabilities Appendix 1 - AER Template


APPENDIX 1

AER Template

1

2016P0007-03

DateSignatureGroup/Facility manager

(or nominated, suitably qualified and experienced deputy)

National Grid Reference (6E, 6 N) 304900E, 241400N

A description of the activities/processes at the site for the reporting year. This should include information such as production increases or decreases on site, any infrastructural changes, environmental performance which was measured during the reporting year and an overview of compliance with your licence listing all exceedances of licence limits (where applicable) and what they relate to e.g. air, water, noise.

Astellas Ireland Co., Ltd. manufacture bulk active pharmaeuticals in three dedicated plants. The incinerator ran for similar hours in 2016 as for 2015 - the reduced hours of operation for 2015 and 2016 are due to less waste being produced with reduced production in the P1 production facility due to market requirements. Overall site production for 2016 is 11% lower than 2015. There was a minor non-compliance with the elv for suspended solids from emission point EP-WW-001 during 2016 (the result from the ISO 17025 accredited laboratory is higher than the result obtained in-house for a split sample. The in-house result was within the elv). The EPA reported a result for VOCs and particulates above elv for EP-IN-001 - AICL have carried out testing to assess if the method of measurement of particulates is suitable for the operating conditions on-site. Results have been submitted to the EPA for review.There were no environmental complaints received.

Declaration:All the data and information presented in this report has been checked and certified as being accurate. The quality

of the information is assured to meet licence requirements.

NACE Code 2110Class/Classes of Activity 5.16, 11.1, 11.2(e), 11.6

__________________________28/03/2017

Facility Information Summary

Licence Register NumberName of site Astellas Ireland Co., Ltd.Site Location Damastown Industrial Park, Damastown Road, Mulhuddart, Dublin

AER Reporting Year

1

AIR-summary template Lic No: P0007-03 Year 2016Answer all questions and complete all tables where relevant

2No

3Basic air monitoring checklist AGN2 Yes

Table A1: Licensed Mass Emissions/Ambient data-periodic monitoring (non-continuous)

Emission reference no: Parameter/ Substance

Frequency of Monitoring

ELV in licence or any revision therof Licence Compliance criteria Measured value

Unit of measurement

Compliant with licence limit Method of analysis

Annual mass load (kg)

Comments -reason for change in % mass load from previous year if applicable

EP-UT-001 volumetric flow Annually 6500 All 1-hour averages < ELV 1589 Nm3/hour yes OTH n/a Slight increase from 2015

EP-UT-001 Particulates Annually 5No 30min mean can exceed the ELV 0.7 mg/Nm3 yes OTH 2.6

Decrease on result for 2015 - boiler can be on low or high fire during monitoring depending on site requirements

EP-UT-001 Carbon monoxide (CO) Annually 100No 30min mean can exceed the ELV 5.6 mg/Nm3 yes EN 15058:2004 21

Increase on result for 2015 - boiler can be on low or high fire during monitoring depending on site requirements

EP-UT-001Nitrogen oxides (NOx/NO2) Annually 200

No 30min mean can exceed the ELV 149.9 mg/Nm3 yes EN 14792:2005 553


EP-UT-001Sulphur oxides (SOx/SO2) Annually 35

No 30min mean can exceed the ELV 7 mg/Nm3 yes OTH 25.8


EP-UT-002 volumetric flow Annually 6500 All 1-hour averages < ELV 1604 Nm3/hour yes OTH n/a


EP-UT-002 Particulates Annually 5No 30min mean can exceed the ELV 0.7 mg/Nm3 yes OTH 2.8


EP-UT-002 Carbon monoxide (CO) Annually 100No 30min mean can exceed the ELV 6.5 mg/Nm3 yes EN 15058:2004 26


EP-UT-002Nitrogen oxides (NOx/NO2) Annually 200

No 30min mean can exceed the ELV 145.9 mg/Nm3 yes EN 14792:2005 594


1Does your site have licensed air emissions? If yes please complete table A1 and A2 below for the current

reporting year and answer further questions. If you do not have licenced emissions and do not complete a solvent management plan (table A4 and A5) you do not need to complete the tables

Yes

Periodic/Non-Continuous Monitoring

Are there any results in breach of licence requirements? If yes please provide brief details in the comment section of TableA1 below

Was all monitoring carried out in accordance with EPA guidance note AG2 and using the basic air monitoring checklist?

Additional information

http://www.epa.ie/pubs/advice/air/emissions/basicairmonitoringchecklistforlicensees.html



http://www.epa.ie/downloads/advice/air/emissions/Air Mon Guid Note _AG2_ - final version2.pdf

2

AIR-summary template Lic No: P0007-03 Year 2016

EP-UT-002Sulphur oxides (SOx/SO2) Annually 35

No 30min mean can exceed the ELV 4.8 mg/Nm3 yes OTH 19.5


EP-P1-001 volumetric flow Monthly 15000 All 1-hour averages < ELV 2471 Nm3/hour yes OTH N/A

EP-P1-001TA Luft organic substances class 1 Monthly 20

No 30min mean can exceed the ELV 1 mg/Nm3 yes EN 13649:2001 5.8

Decrease on 2015 mass due to reduced production in this plant.


No 30min mean can exceed the ELV <0.6 mg/Nm3 yes EN 13649:2001 <3.4

All monthly results in 2016 less than limit of detection.


No 30min mean can exceed the ELV 2.4 mg/Nm3 yes EN 13649:2001 13.9

Increase on 2015 mass mainly attritibutable to a higher than average result (well within limits) in February 2016

EP-P1-001 Total Particulates Monthly 1No 30min mean can exceed the ELV 0.38 mg/Nm3 yes OTH 2.1

EP-P1-001 Hydrogen Chloride Monthly 30No 30min mean can exceed the ELV 0.33 mg/Nm3 yes EN 1911-1 to 3:2003 1.6

Monthly result generally close to limit of detection.

EP-P1-002 volumetric flow Monthly 4000 All 1-hour averages < ELV n/a Nm3/hour yes OTH N/AEP-P1-002 scrubber was not used in 2016 as this plant was not operational


No 30min mean can exceed the ELV 0 mg/Nm3 yes EN 13649:2001 0

EP-P1-002 scrubber was not used in 2016 as this plant was not operational







EP-P1-002 Total Particulates Monthly 1No 30min mean can exceed the ELV 0 mg/Nm3 yes OTH 0


EP-P1-002 Hydrogen Chloride Monthly 30No 30min mean can exceed the ELV 0 mg/Nm3 yes EN 1911-1 to 3:2003 0




No 30min mean can exceed the ELV <0.5 mg/Nm3 yes OTH <10

All monthly results in 2016 are below the limit of detection.



Most monthly results are below the limit of detection.



Most monthly results are below the limit of detection.

EP-P2-001 Total Particulates Monthly 1No 30min mean can exceed the ELV 0.4 mg/Nm3 yes OTH 9.3

EP-P2-001 Hydrogen Chloride Monthly 30No 30min mean can exceed the ELV 0.4 mg/Nm3 yes OTH 9 Slight increase on result from 2015



No 30min mean can exceed the ELV <0.7 mg/Nm3 yes EN 13649:2001 <13.6

All monthly results in 2016 are below the limit of detection.

3




Increase on result for 2015 due to an increase in hours of operation. All results well within ELV.



Increase on result for 2015 due to an increase in hours of operation. All results well within ELV.

EP-P3-001 Total Particulates Monthly 1No 30min mean can exceed the ELV 0.45 mg/Nm3 yes OTH 8.6 Slight increase on result from 2015

EP-P3-001 Hydrogen Chloride Monthly 30No 30min mean can exceed the ELV 0.36 mg/Nm3 yes EN 1911-1 to 3:2003 6.9 Slight increase on result from 2015

EP-IN-001 volumetric flow Quarterly 29000 All 1-hour averages < ELV 1817 Nm3/hour SELECT OTH N/A

EP-IN-001 Hydrogen bromide Quarterly 2No 30min mean can exceed the ELV <0.46 mg/Nm3 yes OTH <1.56

All 2016 results were below limit of detection.

EP-IN-001 Hydrogen fluoride Quarterly 1No 30min mean can exceed the ELV <0.10 mg/Nm3 yes OTH <0.34


EP-IN-001

Sum of Cadmium (as Cd) and thallium (as Tl) and their compounds Annually 0.05


EP-IN-001

Sum of antimony (as Sb), arsenic (as As), lead (as Pb), chromium (as Cr), cobalt (as Co), copper (as Cu), manganese (as Mn), nickel (as Ni) and vanadium (as V) Annually 0.5



EP-IN-001Mercury (as Hg) and its compounds Annually 0.05

No 30min mean can exceed the ELV <0.0001 ng/Nm3 yes EN 14385:2004 0 or <0.0003 Result less than limit of detection.

EP-IN-001 Dioxins/furans Bi-annual 0.1No 30min mean can exceed the ELV 0.004 ngTEQ/Nm3 yes EN 1948-1 to3:2003 1.48E-08 Minor increase on 2015 emission levels.

Note 1: Volumetric flow shall be included as a reportable parameter

4


4Yes

5No

6Yes

7No

Table A2: Summary of average emissions -continuous monitoring

Emission reference no:

Parameter/ Substance ELV in licence or any revision therof

Averaging Period Compliance Criteria Units of measurement

Annual Emission (kg)

Annual maximum (mg/Nm3)

Monitoring Equipment downtime (hours)

Number of ELV exceedences in current reporting year

Comments

EP-IN-001 Dust

10 Annual

97 % of all annual 30-minute values < ELV mg/Nm3

10 4.8 0 0 Annual result higher than 2015 as incinerator run hours were 15% higher. Dust monitoring carried out by EPA in May 2016 was above elv - this is still under investigation.

EP-IN-001 Hydrogen chloride10 Annual 97 % of all annual 30-minute

values < ELV mg/Nm32.1 0.95 0 0 Annual result lower than for 2015.

EP-IN-001Total Organic Carbon (as C)

10 Annual97 % of all annual 30-minute values < ELV mg/Nm3

11.9 9.7 0 0 Annual result higher than 2015 as incinerator run hours were 15% higher.

EP-IN-001Nitrogen oxides (NOx/NO2)

400 Annual97 % of all annual 30-minute values < ELV mg/Nm3

525 234 0 0 Annual result higher than 2015 as incinerator run hours were 15% higher.

EP-IN-001Sulphur oxides (SOx/SO2)

50 Annual 97 % of all annual 30-minute values < ELV mg/Nm3

1.5 1.3 0 0 Annual result similar to 2015.

EP-IN-001 Carbon monoxide (CO)20 Annual 97 % of all annual 30-minute

values < ELV mg/Nm32.3 3.4 0 0 Annual result lower than for 2015.

note 1: Volumetric flow shall be included as a reportable parameter.

Table A3: Abatement system bypass reporting table Bypass protocol

Date* Duration** (hours) Location

Continuous Monitoring

Does your site carry out continuous air emissions monitoring?

If yes please review your continuous monitoring data and report the required fields below in Table A2 and compare it to its relevant Emission Limit Value (ELV)

Did continuous monitoring equipment experience downtime? If yes please record downtime in table A2 below

Do you have a proactive service agreement for each piece of continuous monitoring equipment?

Did your site experience any abatement system bypasses? If yes please detail them in table A3 below

* this should include all dates that an abatement system bypass occurred

** an accurate record of time bypass beginning and end should be logged on site and maintained for future Agency inspections please refer to bypass protocol link

Reason for bypass Corrective actionImpact magnitude

http://www.epa.ie/pubs/advice/licensee/Protocol on bypass Final.pdf

5


8 Do you have a total Emission Limit Value of direct and fugitive emissions on site? if yes please fill out tables A4 and A5No

Solvent regulations

Reporting year Total solvent input on site (kg)

Total VOC emissions to Air from entire

site (direct and fugitive)

Total VOC emissions as %of solvent input Total Emission Limit Value

(ELV) in licence or any revision therof

Compliance

SELECT

SELECT

(I) Inputs (kg)

Solvent

(I) Inputs (kg)

Organic solvent emission in waste

gases(kg)

Solvents lost in water (kg)

Collected waste solvent (kg) Fugitive Organic Solvent (kg)

Solvent released in other ways e.g. by-passes (kg)

Solvents destroyed onsite through physical reaction e.g. incineration(kg)

Total emission of Solvent to air (kg)

Toluene58,068 115 0 0 253 0 471 368

Other NMVOCs397,769 762 1 0 1,315 0 271,499 2,078

Total 2,446

(O) Outputs (kg)

Table A4: Solvent Management Plan Summary Total VOC Emission limit value

Table A5: Solvent Mass Balance summary

Please refer to linked solvent regulations to complete table 5 and 6

Solvent use and management on site

http://www.epa.ie/pubs/legislation/air/solvents/NEW SI 565 OF 2012 EU INSTALLATIONS ACTIVITIES USING ORGANIC SOLVENTS REGS 2012.pdf

http://www.epa.ie/pubs/legislation/air/solvents/NEW SI 565 OF 2012 EU INSTALLATIONS ACTIVITIES USING ORGANIC SOLVENTS REGS 2012.pdf

1

AER Monitoring returns summary template-WATER/WASTEWATER(SEWER) Lic No: P0007-03 Year 2016

2

Yes

Location reference

Location relative to

site activitiesPRTR Parameter

Licenced Parameter

Monitoring date

ELV or trigger level in licence or any revision

thereof*

Licence Compliance

criteriaMeasured value

Unit of measurement

Compliant with licence

Comments

EP-SW-001 onsite SELECT COD Weekly 30 N/A 12.3 mg/L yesEP-SW-001 onsite SELECT pH Weekly 6 to 9 N/A 7 pH units yes

*trigger values may be agreed by the Agency outside of licence conditions

Location Reference

Date of inspection Source of

contamination SELECTSELECT

3Yes

4

External /Internal Lab Quality checklist

Assessment of results checklist Yes

Table W3: Licensed Emissions to water and /or wastewater (sewer)-periodic monitoring (non-continuous)


Emission released to

Parameter/ SubstanceNote 1 Type of sample

Frequency of monitoring Averaging period

ELV or trigger values in licence or any revision therofNote 2 Licence Compliance criteria Measured value

Unit of measurement

Compliant with licence Method of analysis

Procedural reference source

Procedural reference standard number

Annual mass load (kg) Comments

EP-WW-001 Wastewater/Sewer

Ammonia (as N) composite Quarterly Annual See comments SELECT 1.17 mg/L yesDigestion +

SpectrophotometryB.S. (British Standard)

BS 2690: Part 7:1969 / BS 6068 Part 2.11:1984

61.25Action level of 40 mg/l agreed

with Dublin City Council.


BOD composite Monthly Annual 300 mg/lAll results < 1.2 times ELV, plus 8 from ten results must be < ELV

17.5 mg/L yesDissolved Oxygen Meter (Electrode)

UK SCA "Blue Book" series

Standard 5-day test

914

Mass higher than 2015 due to higher annual average and higher volumetric volumes

(10.9%).


COD composite Weekly Annual 1000 mg/lAll results < 1.2 times ELV, plus 8 from ten results must be < ELV

165.9 mg/L yesDigestion +

SpectrophotometryISO 6060-1989 8668


(10.9%).


Sulphate composite Fortnightly Annual 800 mg/lAll results < 1.2 times ELV, plus 8 from ten results must be < ELV

213.9 mg/L yesSpectrophotometry

(Colorimetry) US EPA 325.1 & 325.2 11179


(10.9%).


Suspended Solids composite Weekly Annual 400 mg/lAll results < 1.2 times ELV, plus 8 from ten results must be < ELV

101.4 mg/L yes Gravimetric analysisAPHA / AWWA

"Standard Methods"

Method 2540D 5280

Mass higher than 2015 due to higher volumetric volumes

(10.9%). Average concentration similar to 2015. 1 weekly result was >ELV, but in-house result for same split sample was well within licence limit. Repeated

result was at elv.


1

Does your site have licensed emissions direct to surface water or direct to sewer? If yes please complete table W2 and W3 below for the current reporting year and answer further questions. If you do not have licenced emissions you only need to complete

table W1 and or W2 for storm water analysis and visual inspectionsYes

Table W2 Visual inspections-Please only enter details where contamination was observed.

Description of contamination Corrective action Comments

Was it a requirement of your licence to carry out visual inspections on any surface water discharges or watercourses on or near your site? If yes please complete table W2 below summarising only any evidence of contamination noted during visual inspections All surface water is visually inspected before discharge to river Tolka - no

contaminated noted.

Table W1 Storm water monitoring

Licensed Emissions to water and /or wastewater(sewer)-periodic monitoring (non-continuous)

Was there any result in breach of licence requirements? If yes please provide brief details in the comment section of Table W3 below see table W3 for details

Was all monitoring carried out in accordance with EPA guidance and checklists for Quality of Aqueous Monitoring Data Reported to the EPA? If no please detail what areas

require improvement in additional information box

http://www.epa.ie/pubs/conferencesandevents/aq/



http://www.epa.ie/pubs/conferencesandevents/aq/Cl_dataqualityass.doc

http://www.epa.ie/pubs/conferencesandevents/aq/Cl_dataqualityass.doc

2



Chlorides (as Cl) composite Fortnightly Annual 2000 mg/lAll results < 1.2 times ELV, plus 8 from ten results must be < ELV

646.4 mg/L yesSpectrophotometry

(Colorimetry) US EPA 325.1 & 325.2 33781


(10.9%).


Phosphate (as P) composite Monthly Annual 10 mg/lAll results < 1.2 times ELV, plus 8 from ten results must be < ELV

<0.02 mg/L yesSpectrophotometry

(Colorimetry) US EPA 325.1 & 325.2 1 No significant change to 2015.


Nitrate (as N) composite Annual Annual N/A N/A 0.13 mg/L N/ASpectrophotometry

(Colorimetry) US EPA 325.1 & 325.2 6.5

Mass higher than 2015 as it was based on a below the LOD

value.


Phenols composite Annual Annual N/A N/A <0.025 mg/L N/ALC (Liquid

Chromatography)Other (please

specify)HPLC <1.31 No significant change to 2015.


Arsenic and compounds (as As)

composite Annual Annual N/A N/A 1.2 µg/L N/A

ICP / ICPMS (Inductively Coupled

Plasma - Mass Spectrometry)

APHA / AWWA "Standard Methods"

Method 3125B 0.06 No significant change to 2015.


Cadmium and compounds (as Cd)

composite Annual Annual N/A N/A <1 µg/L N/A




Method 3125B <0.05 Higher limit of detection quoted in 2015.


Chromium and compounds (as Cr)







Copper and compounds (as Cu)

composite Annual Annual N/A N/A <8.5 µg/L N/A




Method 3125B <0.44 No significant change to 2015.


Mercury and compounds (as Hg)

composite Annual Annual N/A N/A <0.01 µg/L N/A




Method 3125B <0.0005Only one result per year, which

was below the limit of detection.


Nickel and compounds (as Ni)







Lead and compounds (as Pb)





Method 3125B 0.03 Mass lower than 2015 due to lower annual average


Zinc and compounds (as Zn)





Method 3125B 0.6 Mass lower than 2015 due to lower annual average


Suspended Solids composite Daily Annual 30All results < 1.2 times ELV, plus 8 from ten results must be < ELV

7 mg/L yes Gravimetric analysisOther (please

specify)

Standard method as per Standard Methods for the Examination of Water and Wastewater 20th Edition

13.45

Mass emission lower than 2015.

All daily results in 2016 were below the 30 mg/l elv.


Cadmium and compounds (as Cd)

composite Monthly Annual 50 µg/lAll results < 1.2 times ELV, plus 8 from ten results must be < ELV

<0.23 µg/L yes




Method 3125B <0.001


Thallium and compounds (as Tl)


1.8 µg/L yes




Method 3125B <0.01


Arsenic and compounds (as As)


7 µg/L yes




Method 3125B 0.01


Lead and compounds (as Pb)


3.1 µg/L yes




Method 3125B <0.01

3



Chromium and compounds (as Cr)


37.8 µg/L yes




Method 3125B 0.07


Copper and compounds (as Cu)


9.3 µg/L yes




Method 3125B 0.02


Nickel and compounds (as Ni)


3.5 µg/L yes




Method 3125B <0.01


Zinc and compounds (as Zn)

composite Monthly Annual 1.5 mg/lAll results < 1.2 times ELV, plus 8 from ten results must be < ELV

8.1 µg/L yes




Method 3125B 0.01


Mercury and compounds (as Hg)


<0.01 µg/L yes




Method 3125B <0.00003


PCDD + PCDF (dioxins + furans)(as Teq)

composite Annual Annual 0.3 ng/l All results < 1.2 times ELV, plus 8 from ten results must be < ELV

0.006 ng/L yesGCMS

B.S. (British Standard)

1948-2 1.10E-08

Note 1: Volumetric flow shall be included as a reportable parameterNote 2: Where Emission Limit Values (ELV) do not apply to your licence please compare results against EQS for Surface water or relevant receptor quality standards

4


5 Yes

6No

7Yes

8No

Table W4: Summary of average emissions -continuous monitoring


Emission released to Parameter/ Substance

ELV or trigger values in licence or any revision thereof

Averaging Period

Compliance Criteria

Units of measurement

Annual Emission for current reporting year (kg)

% change +/- from previous reporting year

Monitoring Equipment downtime (hours)

Number of ELV exceedences in reporting year


volumetric flow 800 24 hour No flow value

shall exceed the .specific limit

m3/day 124 m3/day 6% 0 0


volumetric flow 125 1 hour No flow value

shall exceed the .specific limit

m3/hour 87.6 m3/hour 4% 0 0


Temperature 42

No temperature value shall

exceed the limit.value

degrees C 13.3°C 6% 0 0


pH >6 <10No pH value shall deviate from the specified range.

pH units 8 1% 0 0

SELECT SELECT SELECT SELECT SELECT

note 1: Volumetric flow shall be included as a reportable parameter.

Table W5: Abatement system bypass reporting tableDate Duration

(hours)Location Resultant

emissionsReason for bypass

Corrective action*

Was a report submitted to the EPA?

When was this report submitted?

SELECT

*Measures taken or proposed to reduce or limit bypass frequency

Continuous monitoring Additional Information

Did continuous monitoring equipment experience downtime? If yes please record downtime in table W4 belowDo you have a proactive service contract for each piece of continuous monitoring equipment on site?Did abatement system bypass occur during the reporting year? If yes please complete table W5 below

Comments

No significant change from 2015 average pH.

Minor increase from 2015.

Minor increase from 2015.

Minor increase in effluent temperature in 2016 is not process related.

Does your site carry out continuous emissions to water/sewer monitoring?

If yes please summarise your continuous monitoring data below in Table W4 and compare it to its relevant Emission Limit Value (ELV)

1

Bund/Pipeline testing template Lic No: P0007-03 Year 2016

Bund testing Additional information

1 Yes 2 Please provide integrity testing frequency period 3 years

3 Yes 4 How many bunds are on site? 195 How many of these bunds have been tested within the required test schedule? 196 How many mobile bunds are on site? 167 Are the mobile bunds included in the bund test schedule? Yes 8 How many of these mobile bunds have been tested within the required test schedule? 169

10Please list any sump integrity failures in table B1

11 Yes 12 Yes 13 Is the Fire Water Retention Pond included in your integrity test programme? Yes

Bund/Containment structure ID Type Specify Other type Product containment Actual capacity Capacity required* Type of integrity test Other test type Test date

Integrity reports maintained on site? Results of test

Integrity test failure explanation <50 words

Corrective action taken

Scheduled date for retest

Results of retest(if in current reporting year)

WP0520 WWB Tank reinforced concrete Feed for WWTP N/A N/A Hydraulic test 10/03/2016 Yes Pass N/A 2019WP0530 pH Adjusting tank reinforced concrete Process water N/A N/A Hydraulic test 19/04/2016 Yes Pass N/A 2019WP0793 Stormwater tank reinforced concrete Stormwater 300 m3 N/A Hydraulic test 29/03/2016 Yes Pass N/A 2019WP0792 Stormwater tank reinforced concrete Stormwater 300 m3 N/A Hydraulic test 24/03/2016 Yes Pass N/A 2019WP0791 Stormwater tank reinforced concrete Stormwater 300 m3 N/A Hydraulic test 14/03/2016 Yes Pass N/A 2019WP0570 Final water tank reinforced concrete Treated process water 500 m3 N/A Hydraulic test 23/05/2016 Yes Pass N/A 2019WP0580 Dump tank reinforced concrete Normally empty 400 m3 N/A Hydraulic test 21/03/2016 Yes Pass N/A 2019

Drum Stores sump reinforced concreteStormwater - any potential spill N/A N/A Hydraulic test 30/03/2016 Yes Pass N/A 2019

Firewater Retention Pond other (please specify) Butyl liner Empty 3000 m3 Hydraulic test 13/04/2016 Yes Pass N/A 2019* Capacity required should comply with 25% or 110% containment rule as detailed in your licence Commentary

15 bunding and storage guidelines Yes 16 Are channels/transfer systems to remote containment systems tested? Yes 17 Are channels/transfer systems compliant in both integrity and available volume? SELECT

1 Yes 2 Please provide integrity testing frequency period 3 years

*please note integrity testing means water tightness testing for process and foul pipelines (as required under your licence)

Structure ID Type system Material of construction:

Does this structure have Secondary containment?

Type of secondary containment

Type integrity testingIntegrity reports maintained on site? Results of test

Integrity test failure explanation <50 words

Corrective action taken

Scheduled date for retest

Results of retest(if in current reporting year)

Process water pipework system Process polypropylene Yes N/A Pressure tested. Yes

One short section failed - further testing required before repair plan can be prepared.

Further investigation required before repair.

Repair scheduled for completion before end May 2017 if required. End May 2017 N/A

WWC1 tank Process polypropylene Yes Double lined tank Visual Yes Pass MonthlyWWC2 tank Process polypropylene Yes Double lined tank Visual Yes Pass MonthlyWWC3 tank Process polypropylene Yes Double lined tank Visual Yes Pass Monthly

dropdown menu click to see options

Are you required by your licence to undertake integrity testing on bunds and containment structures ? if yes please fill out table B1 below listing all new bunds and containment structures on site, in addition to all bunds which failed the integrity test-all bunding structures which failed including mobile bunds must be listed in the table below, please include all bunds outside the licenced testing period (mobile bunds and chemstore included)

Are you required by your licence to undertake integrity testing* on underground structures e.g. pipelines or sumps etc ? if yes please fill out table 2 below listing all underground structures and pipelines on site which failed the integrity test and all which have not been tested withing the integrity test period as specified

Table B2: Summary details of pipeline/underground structures integrity test

How many sumps on site are included in the integrity test schedule?How many of these sumps are integrity tested within the test schedule?

Table B1: Summary details of bund /containment structure integrity test

Please use commentary for additional details not answered by tables/ questions above

Does the site maintain a register of bunds, underground pipelines (including stormwater and foul), Tanks, sumps and containers? (containers refers to "Chemstore" type units and mobile bunds)

Has integrity testing been carried out in accordance with licence requirements and are all structures tested in line with BS8007/EPA Guidance?

Do all sumps and chambers have high level liquid alarms?If yes to Q11 are these failsafe systems included in a maintenance and testing programme?

Pipeline/underground structure testing

http://www.epa.ie/downloads/advice/general/materials storage.pdf

1

Groundwater/Soil monitoring template Lic No: P0007-03 Year 2016

Comments

1yes

2 no

3 no

4Groundwater monitoring template SELECT

5no

6

7 N/A8 yes9 yes

10 no11 no

12 no

Table 1: Upgradient Groundwater monitoring results

Date of sampling

Sample location reference

Parameter/ Substance Methodology

Monitoring frequency

Maximum Concentration++

Average Concentration+ unit GTV's* SELECT**

Upward trend in pollutant concentration over last 5 years of monitoring data

12/10/2016 YMW1Alkalinity-total

Method 2320B, AWWA /APHA Annual 275 mg/l N/A no


Method 2320B, AWWA /APHA Annual 455 mg/l N/A No


Method 2320B, AWWA/APHA Annual 28 mg/l N/A no





12/10/2016 YMW1Ammoniacal nitrogen BS 2690 Part 7 Annual <0.2 mg/l 0.065-0.175 no



12/10/2016 YMW6Ammoniacal nitrogen BS 2690 Part 7 Annual 0.576 mg/l 0.065-0.175 no


N/APlease specify the proposed time frame for the remediation strategyIs there a licence condition to carry out/update ELRA for the site?

Is there evidence that contamination is migrating offsite?

Is the contamination related to operations at the facility (either current and/or historic)

Have potential receptors been identified on and off site? Has a Conceptual Site Model been developed for the site?

Please provide an interpretation of groundwater monitoring data in the interpretation box below or if you require additional space please

include a groundwater/contaminated land monitoring results interpretaion as an additional section in this AER

Figures are available for dissolved and total total sodium, potassium, calcium and magnesium. Figures are provided for the total measured values. With the exception of the parameter mentioned below, measured values for all groundwater samples taken in October 2016 are within the relevant GW regulation limit value. Levels for ammonical nitrogen in the downgradient locations YMW3, YMW4 and YMW9 and upgradient locations YMW 6 and YMW8 are marginally in exceedence of the GW regulations value and suggests this anomaly is natural or background fluctuation. Based on a review of baselines results by our groundwater consultants, recommendations were made to re-assign YMW2 as an upgradient location.

Are you required to carry out groundwater monitoring as part of your licence requirements?Are you required to carry out soil monitoring as part of your licence requirements?

Have actions been taken to address contamination issues?If yes please summarise remediation strategies proposed/undertaken for the site

Do monitoring results show that groundwater generic assessment criteria such as GTVs or IGVs are exceeded or is there an upward trend in results for a substance? If yes, please complete the Groundwater Monitoring Guideline Template Report (link in cell G8) and submit separately through ALDER as a licensee return AND answer questions 5-12 below.

Do you extract groundwater for use on site? If yes please specify use in comment section

Has any type of risk assesment been carried out for the site?

http://www.epa.ie/pubs/advice/waste/contaminatedland/contaminatedland/Template for Groundwater Monitoring Report.docx



2


12/10/2016 YMW1 ChloridesEPA Methods 325.1 & 325.2 Annual 60.5 mg/l 24-187.5 IGV 30 mg/l no

12/10/2016 YMW2 ChloridesEPA Methods 325.1 & 325.2 Annual 16 mg/l 24-187.5 IGV 30 mg/l no

12/10/2016 YMW5 ChloridesEPA Methods 325.1 & 325.2 Annual 141 mg/l 24-187.5 IGV 30 mg/l yes


12/10/2016 YMW8 ChloridesEPA Methods 325.1 & 325.2 Annual 162 mg/l 24-187.5 IGV 30 mg/l yes

12/10/2016 YMW1 EPH Annual 165 ug/l N/A no12/10/2016 YMW2 EPH Annual <46 ug/l N/A no12/10/2016 YMW5 EPH Annual <46 ug/l N/A no12/10/2016 YMW6 EPH Annual <46 ug/l N/A no12/10/2016 YMW8 EPH Annual <46 ug/l N/A no12/10/2016 YMW1 GRO GC-FID Annual <50 ug/l N/A no12/10/2016 YMW2 GRO GC-FID Annual <50 ug/l N/A no12/10/2016 YMW5 GRO GC-FID Annual <50 ug/l N/A no12/10/2016 YMW6 GRO GC-FID Annual <50 ug/l N/A no12/10/2016 YMW8 GRO GC-FID Annual <50 ug/l N/A no

12/10/2016 YMW1 NitrateEPA method 325.1 & 325.2 Annual <0.3 mg/l 37.5 no


12/10/2016 YMW5 NitrateEPA method 325.1 & 325.2 Annual 0.757 mg/l 37.5 no



12/10/2016 YMW1 NitriteEPA method 325.1 & 325.2 Annual <0.05 mg/l 0.375 no





12/10/2016 YMW1 SVOC EPA 8270D Annual <1 ug/l N/A no12/10/2016 YMW2 SVOC EPA 8270D Annual <1 ug/l N/A no12/10/2016 YMW5 SVOC EPA 8270D Annual <1 ug/l N/A no12/10/2016 YMW6 SVOC EPA 8270D Annual <1 ug/l N/A no12/10/2016 YMW8 SVOC EPA 8270D Annual <1 ug/l N/A no

12/10/2016 YMW1 PhosphateEPA method 325.1 & 325.2 Annual <0.05 mg/l 35 no





12/10/2016 YMW1 SulphateEPA method 325.1 & 325.2 Annual 68.3 mg/l 187.5 no



12/10/2016 YMW6 SulphateEPA method 325.1 & 325.2 Annual 120 mg/l 187.5 no


Analysis of petroleum hydrocarbons in environmental media.

3


12/10/2016 YMW1TPH/Oils & Greases HMSO method Annual <1 mg/l N/A no

12/10/2016 YMW2TPH/Oils & Greases HMSO method Annual 1.24 mg/l N/A no

12/10/2016 YMW5TPH/Oils & Greases HMSO method Annual 1.08 mg/l N/A no



12/10/2016 YMW1 VOCs US EPA 8260b Annual <1 ug/l N/A no12/10/2016 YMW2 VOCs US EPA 8260b Annual <1 ug/l N/A no12/10/2016 YMW5 VOCs US EPA 8260b Annual <1 ug/l N/A no12/10/2016 YMW6 VOCs US EPA 8260b Annual <1 ug/l N/A no12/10/2016 YMW8 VOCs US EPA 8260b Annual <1 ug/l N/A no12/10/2016 YMW1 Calcium US EPA 6010B Annual 105 mg/l N/A IGV 200 mg/l no12/10/2016 YMW2 Calcium US EPA 6010B Annual 182 mg/l N/A IGV 200 mg/l no12/10/2016 YMW5 Calcium US EPA 6010B Annual 77.3 mg/l N/A IGV 200 mg/l no12/10/2016 YMW6 Calcium US EPA 6010B Annual 149 mg/l N/A IGV 200 mg/l no12/10/2016 YMW8 Calcium US EPA 6010B Annual 195 mg/l N/A IGV 200 mg/l no12/10/2016 YMW1 Potassium US EPA 6010B Annual 14.8 mg/l N/A IGV 5 mg/l no12/10/2016 YMW2 Potassium US EPA 6010B Annual 2.2 mg/l N/A IGV 5 mg/l no12/10/2016 YMW5 Potassium US EPA 6010B Annual 3.6 mg/l N/A IGV 5 mg/l no12/10/2016 YMW6 Potassium US EPA 6010B Annual 3.45 mg/l N/A IGV 5 mg/l no12/10/2016 YMW8 Potassium US EPA 6010B Annual <0.2 mg/l N/A IGV 5 mg/l no12/10/2016 YMW1 Sodium US EPA 6010B Annual 53.2 mg/l 150 no12/10/2016 YMW2 Sodium US EPA 6010B Annual 10.3 mg/l 150 no12/10/2016 YMW5 Sodium US EPA 6010B Annual 51.3 mg/l 150 no12/10/2016 YMW6 Sodium US EPA 6010B Annual 33.1 mg/l 150 no12/10/2016 YMW8 Sodium US EPA 6010B Annual 105 mg/l 150 yes12/10/2016 YMW1 Magnesium US EPA 6010B Annual 21.2 mg/l N/A no12/10/2016 YMW2 Magnesium US EPA 6010B Annual 23.3 mg/l N/A no12/10/2016 YMW5 Magnesium US EPA 6010B Annual 7.16 mg/l N/A no12/10/2016 YMW6 Magnesium US EPA 6010B Annual 28.2 mg/l N/A no12/10/2016 YMW8 Magnesium US EPA 6010B Annual 22.8 mg/l N/A no

SELECT SELECT.+ where average indicates arithmetic mean.++ maximum concentration indicates the maximum measured concentration from all monitoring results produced during the reporting year

Table 2: Downgradient Groundwater monitoring results

Date of sampling




Maximum Concentration

Average Concentration unit GTV's* SELECT**

Upward trend in yearly average pollutant concentration over last 5 years of monitoring data


Method 2320B, AWWA /APHA Annual 340 mg/l N/A no







4










12/10/2016 YMW2 EPH Annual <46 ug/l N/A no12/10/2016 YMW3 EPH Annual <46 ug/l N/A no12/10/2016 YMW4 EPH Annual <46 ug/l N/A no12/10/2016 YMW7 EPH Annual <46 ug/l N/A no12/10/2016 YMW9 EPH Annual 122 ug/l N/A no12/10/2016 YMW3 GRO GC-FID Annual <50 ug/l N/A no12/10/2016 YMW4 GRO GC-FID Annual <50 ug/l N/A no12/10/2016 YMW7 GRO GC-FID Annual <50 ug/l N/A no12/10/2016 YMW9 GRO GC-FID Annual <50 ug/l N/A no









12/10/2016 YMW3 SVOC EPA 8270D Annual <1 ug/l N/A no12/10/2016 YMW4 SVOC EPA 8270D Annual <1 ug/l N/A no12/10/2016 YMW7 SVOC EPA 8270D Annual <1 ug/l N/A no12/10/2016 YMW9 SVOC EPA 8270D Annual <1 ug/l N/A no



12/10/2016 YMW7 PhosphateEPA method 325.1 & 325.2 Annual 0.06 mg/l 35 no






Analysis of petroleum hydrocarbons in environmental media.

5






12/10/2016 YMW3 VOCs US EPA 8260b Annual <1 ug/l N/A no12/10/2016 YMW4 VOCs US EPA 8260b Annual <1 ug/l N/A no12/10/2016 YMW7 VOCs US EPA 8260b Annual <1 ug/l N/A no12/10/2016 YMW9 VOCs US EPA 8260b Annual <1 ug/l N/A no12/10/2016 YMW3 Calcium US EPA 6010B Annual 152 mg/l N/A IGV 200 mg/l no12/10/2016 YMW4 Calcium US EPA 6010B Annual 139 mg/l N/A IGV 200 mg/l no12/10/2016 YMW7 Calcium US EPA 6010B Annual 107 mg/l N/A IGV 200 mg/l no12/10/2016 YMW9 Calcium US EPA 6010B Annual 291 mg/l N/A IGV 200 mg/l no12/10/2016 YMW3 Potassium US EPA 6010B Annual 2.15 mg/l N/A IGV 5 mg/l no12/10/2016 YMW4 Potassium US EPA 6010B Annual 3.45 mg/l N/A IGV 5 mg/l no12/10/2016 YMW7 Potassium US EPA 6010B Annual 2.67 mg/l N/A IGV 5 mg/l no12/10/2016 YMW9 Potassium US EPA 6010B Annual 3.83 mg/l N/A IGV 5 mg/l no12/10/2016 YMW3 Sodium US EPA 6010B Annual 35.4 mg/l 150 no12/10/2016 YMW4 Sodium US EPA 6010B Annual 26.2 mg/l 150 no12/10/2016 YMW7 Sodium US EPA 6010B Annual 44.1 mg/l 150 no12/10/2016 YMW9 Sodium US EPA 6010B Annual 3.47 mg/l 150 no12/10/2016 YMW3 Magnesium US EPA 6010B Annual 28.3 mg/l N/A no12/10/2016 YMW4 Magnesium US EPA 6010B Annual 19.7 mg/l N/A no12/10/2016 YMW7 Magnesium US EPA 6010B Annual 26.2 mg/l N/A no12/10/2016 YMW9 Magnesium US EPA 6010B Annual 11.4 mg/l N/A no

SELECT SELECT

6


Surface water EQS

Groundwater regulations

GTV's

Drinking water (private supply) standards

Drinking water (public supply) standards

Interim Guideline Values (IGV)

Table 3: Soil results

Date of sampling




Maximum Concentration

Average Concentration unit

SELECT

Where additional detail is required please enter it here in 200 words or less

Groundwater monitoring template*please note exceedance of generic assessment criteria (GAC) such as a Groundwater Threshold Value (GTV) or an Interim Guideline Value (IGV) or an upward

trend in results for a substance indicates that further interpretation of monitoring results is required. In addition to completing the above table, please complete the Groundwater Monitoring Guideline Template Report at the link provided and submit separately through ALDER as a licensee return or as

otherwise instructed by the EPA.

**Depending on location of the site and proximity to other sensitive receptors alternative Receptor based Water Quality standards should be used in addition to the GTV e.g. if the site is close to surface water compare to Surface Water Environmental Quality Standards (SWEQS), If the site is close to a drinking water

supply compare results to the Drinking Water Standards (DWS)

More information on the use of soil and groundwater standards/ generic assessment criteria (GAC) and risk assessment tools is available in the EPA published guidance (see the link in G31)

Guidance on the Management of Contaminated Land and Groundwater at EPA Licensed Sites (EPA 2013).

http://www.environ.ie/en/Legislation/Environment/Water/FileDownLoad,20824,en.pdf





http://www.epa.ie/pubs/advice/drinkingwater/privatewatersupplieshandbook/



http://www.epa.ie/pubs/advice/drinkingwater/publicwatersupplieshandbook/

http://www.epa.ie/pubs/advice/drinkingwater/publicwatersupplieshandbook/

http://www.epa.ie/pubs/advice/water/ground/towardssettingguidelinevaluesfortheprotectionofgroundwaterinireland.html

http://www.epa.ie/pubs/advice/water/ground/towardssettingguidelinevaluesfortheprotectionofgroundwaterinireland.html


http://www.epa.ie/pubs/advice/waste/contaminatedland/contaminatedland/Guidance_on_the_Management_of_Contaminated_Land_and_Groundwater_at_EPA_Licensed_Sites_FINAL.pdf

1

Environmental Liabilities template Lic No: P0007-03 Year 2016

Commentary

1

Submitted and not agreed by EPA; Reviewed ELRA to be submitted in 2017.

2 Review required and completed

Review carried out end 2014 - costings in line with new EPA Guidelines on costings. 2017 review under way.

3 Specify €2,782,000

4 Submitted and not agreed by EPA;

5 Specify

Pollution Legal Liability Insurance in place and parent company backing for other financial provisions.

6 SELECT

Pollution Legal Liability Insurance in place and parent company backing for other financial provisions.

7 Annual - due end March.

8Closure plan submitted and not agreed

by EPA

Closure plan currently under review to meet EPA's most recent Closure Plan costing requirements.

9 Review required and not completed

Closure plan currently under review to meet EPA's most recent Closure Plan costing requirements.

10 Submitted and not agreed by EPA;11 Specify €1,985,00012 Other please specify Parent company backing13 Enter expiry date

Click here to access EPA guidance on Environmental Liabilities and Financial provision

Financial provision for ELRA expiry date

Closure plan initial agreement status

Closure plan review statusFinancial Provision for Closure status

Financial Provision for Closure - amount of cover

Financial provision for Closure expiry dateFinancial Provision for Closure - type

ELRA initial agreement status

ELRA review status

Amount of Financial Provision cover required as determined by the latest ELRA

Financial Provision for ELRA status

Financial Provision for ELRA - amount of cover

Financial Provision for ELRA - type

http://www.epa.ie/pubs/advice/general/Liability_Regulations Final August 2011.pdf

http://www.epa.ie/pubs/advice/general/Liability_Regulations Final August 2011.pdf

1

Environmental Management Programme/Continuous Improvement Programme template Lic No: P0007-03 Year 2016Additional Information

1

Yes

2 Yes

3 Yes

4 Yes

Environmental Management Programme (EMP) reportObjective Category Target Status (% completed) How target was progressed Responsibility Intermediate outcomesEnergy Efficiency/Utility conservation Investigate feasibility of

reducing blower operation on incinerator.

30 Details of alternative blower types have been reviewed - the incinerator operating hours for 2015 were too low to make this a viable project. Project will only proceed if incinerator operating hours increase in future. 2016 update - this project is unlikely to proceed as the operating hours are too low.

Individual Reduced emissions

Energy Efficiency/Utility conservation 2015 - Review feasibility of utilising photovoltaic panels for Warehouse.

0 Potential to generate electrical requirements for Warehouse using photovoltaic panels. 2015 update - company engaged to review this and deemed more beneficial to use PV sitewide rather than on single building. This has significant capital requirement and is being reviewed by senior management - to be progressed in 2016 if economically viable.2016 update - this objective will not be progressed any further until at least 2019.

Energy Support Engineer

Environmental Management System meets requirements of ISO 14001 and is audited against the standard twice yearly. The EMS also meets the requirements of EMAS and is verified annually for the EMS and the content of the annual EMAS Environmental Statement.

Do you maintain an environmental documentation/communication system to inform the public on environmental performance of the facility, as required by the licence

Highlighted cells contain dropdown menu click to view

Does the EMS reference the most significant environmental aspects and associated impacts on-site

Does the EMS maintain an Environmental Management Programme (EMP) as required in accordance with the licence requirements

Do you maintain an Environmental Mangement System (EMS) for the site. If yes, please detail in additional information

2

Environmental Management Programme/Continuous Improvement Programme template Lic No: P0007-03 Year 2016 Energy Efficiency/Utility conservation 2016 - review HVAC to

assess if VSD control suitable. Also review air change rates.

0 HVAC consultant to review. Air change rates must also meet requirements of ATEX.2016 update - VSD to be installed as part of larger project for upgrade of HVACsystem in 2018/2019.


Energy Efficiency/Utility conservation 2016 - Review suitability of using de-stratification fans in Warehouse.

100 The review of this project deemed it not viable at the moment – project shelved until local district heating network project is complete.


Energy Efficiency/Utility conservation 2016 - Replace fluorescent tubes in Engineering Building with LED

100 Complete. Energy Support Engineer

Energy Efficiency/Utility conservation 2016 - Replace hot water pumps in Admin and Warehouse with more efficient pumps.


Energy Efficiency/Utility conservation 2016 - Investigate the option of using biomass boiler in Warehouse for heating.

100 Review complete - with the reduce market price for gas, it is not economically viable to install a biomass boiler.


Energy Efficiency/Utility conservation 2016 - Change hot water system pumps in Admin and Warehouse


Energy Efficiency/Utility conservation 2016 - Replace old air compressor with new efficient unit


Energy Efficiency/Utility conservation 2016 - Replace passing steam traps noted during audit


Energy Efficiency/Utility conservation 2017/2018 - Replace HVAC centrigugal pumps with high efficiency plug fans

0 Plug fans more energy efficient than existing fans.


Energy Efficiency/Utility conservation 2017 - Replace pumps on cooling tower water system

0 Recommendation from pump audit.


Energy Efficiency/Utility conservation 2017 - Update Building Management System to allow for better energy M&T

0 Recommendation from energy audit carried out to meet SI No. 426 of 2014.


Energy Efficiency/Utility conservation 2017 - Replace calorifiers in Admin and Warehouse

0 Recommendation from steam audit.


Energy Efficiency/Utility conservation 2017 - Installation of VSD on Cooling Tower network pumps



3

Environmental Management Programme/Continuous Improvement Programme template Lic No: P0007-03 Year 2016 Energy Efficiency/Utility conservation 2018 - Install VSD pumps

on IW water distribution system



Energy Efficiency/Utility conservation 2018 - Installation of local district heating network



Energy Efficiency/Utility conservation 2018 - Installation of heat pump on cooling tower return



Energy Efficiency/Utility conservation 2019 - Investigate renewables for electricity generation on-site



Additional improvements 2015 - Perform QAL2 on CEMS

100 QAL2 could not be performed,as incinerator was not operational due to unforeseen circumstances - scheduled to be carried out in Q2 2016.2016 update - QAL2 carried out in 2016.

Individual

Groundwater protection 2016 – Re-line bund BU001 with new system of lining – integrity test afterwards

100 Complete. Individual

Groundwater protection 2016 – Perform pressure testing on process drain system

90 Access to some areas was difficult - some civil works to be completed in 2017 to facilitate more testing.

Individual

Groundwater protection 2016 – Repairs to foul sewer drains (Phase 1)


Groundwater protection 2016 – Repairs to stormwater drains (Phase 1)


Groundwater protection 2017 – Repairs to foul sewer drains (Phase 2)


Groundwater protection 2017 – Perform pressure testing on stormwater system

0 Individual

Additional improvements 2016 - Set up beehive on-site

100 Complete. Individual Increases biodiversity.

Additional improvements 2016 - Extend pathway along Pinkeen to allow staff walk along river

100 Complete. Individual Pathway extended allowing staff walk along river.

Waste reduction/Raw material usage efficiency 2017 – Replace breather valve on VE9600 to reduce N2 usage during inertion

0 Changing the breather valve will reduce N2 losses during inertion.

Individual

Additional improvements 2016 - Prepare EMAS Environmental Statement

100 EMAS statement verified by external auditor in May 2016.

Individual

4

Environmental Management Programme/Continuous Improvement Programme template Lic No: P0007-03 Year 2016 Additional improvements 2016 - Conduct survey of

river Tolka and river Pinkeen.

100 Survey conducted every 2 years.

Individual

Additional improvements 2017 - Shutdown P1 Purified Water System

0 System will not be required for P1 production during 2017 – this should make some saving in water consumption.

Individual

Waste reduction/Raw material usage efficiency 2017 - Installation of N2 flowmeters in P2 and P3 plants

0 The N2 usage recorded by these flowmeters will be trended on the BMS to review for detection of leaks and sustain low usage levels on an on-going basis.

Individual

Waste Management 2016 - Audit Indaver Meath facility for disposal of specific hazardous waste

100 Complete. Individual Waste previously shipped to Belgium was sent to this facility in 2016 - this reduces CO2 emissions associated with transport.

Waste Management 2017 - Audit Panda Waste disposal and recycling facilities

100 Complete. Individual Disposal facilities audited following merger of Panda and Greenstar.

Waste Management 2016 - Set up more segregation bins for recycling in Engineering Building.

100 Complete.Bins set up and training given to raise level of awareness and increase recycling of office waste.

Individual

Additional improvements 2017 - Prepare EMAS Environmental Statement

0 Prepare EMAS statement to be verified by external auditor in June 2017.

Individual

Waste reduction/Raw material usage efficiency

2017 - Change MB process to make more product using same volume of solvent as current process.

0 Project on-hold awaiting Corporate direction.

Process Development Team

1

Lic No: P0007-03 Year 2016

1 Yes

2 Noise Guidance note NG4

Yes

3 No4 n/a

5 No

Date of monitoring Time period

Noise location (on site)

Noise sensitive

location -NSL (if applicable) LAeq LA90 LA10 LAmax

Tonal or Impulsive noise* (Y/N)

If tonal /impulsive noise was identified was 5dB penalty applied?

Comments (ex. main noise sources on site, & extraneous noise ex. road traffic)

Is site compliant with noise limits

(day/evening/night)?

6-7/12/2016 15 minutes N/A NSL1 31

No na

This is a predicted result as there is a lot of road traffic to the south and west of the facility. There is also noise with aircraft, as the facility is in the flight path for final appraoch into landing at dublin airport.

Yes

6-7/12/2016 15 minutes N/A NSL2 34

No na


Yes

Noise monitoring summary report

Have there been changes relevant to site noise emissions (e.g. plant or operational changes) since the last noise survey?

Table N1: Noise monitoring summary

Was noise monitoring a licence requirement for the AER period?If yes please fill in table N1 noise summary below

Was noise monitoring carried out using the EPA Guidance note, including completion of the "Checklist for noise measurement report" included in the guidance note as table 6?Does your site have a noise reduction plan When was the noise reduction plan last updated?

http://www.epa.ie/pubs/advice/noise/ng4licenceappssurveysandassessinrelationtoschedactivities.html



2

6-7/12/2016 15 minutes N/A NSL3 33

No na


Yes

06/12/20161 minute at each location

Locations B01 to B07 N/A <56

na

Distant road traffic and plant noise dominant. Background noise levels in range 51 to 55 dB LA90.

Yes



na


Yes



na


Yes



na


Yes

*Please ensure that a tonal analysis has been carried out as per guidance note NG4. These records must be maintained onsite for future inspection

SELECTIf noise limits exceeded as a result of noise attributed to site activities, please choose the corrective action from the following options?

** please explain the reason for not taking action/resolution of noise issues?

Any additional comments? (less than 200 words)

1

Resource Usage/Energy efficiency summary Lic No: P0007-03 Year 2016


1 May-16

2

SEAI - Large Industry Energy Network (LIEN) Yes

3 SELECT

Energy Use Previous year Current year

Production +/- % compared to previous reporting year**

Energy Consumption +/- % vs overall site production*

Total Energy Used (MWHrs) 16,779 16,173 -11.1 8.5Total Energy Generated (MWHrs)Total Renewable Energy Generated (MWHrs)Electricity Consumption (MWHrs) 6,562 6,200Fossil Fuels Consumption:

Heavy Fuel Oil (m3)Light Fuel Oil (m3)

Natural gas (m3) 927,865 924,173Coal/Solid fuel (metric tonnes)

Peat (metric tonnes)Renewable Biomass

Renewable energy generated on site* where consumption of energy can be compared to overall site production please enter this information as percentage increase or decrease compared to the previous reporting year.** where site production information is available please enter percentage increase or decrease compared to previous year

Water Emissions Water Consumption

Water useWater extracted Previous year m3/yr.

Water extracted Current year m3/yr.

Production +/- % compared to previous reporting year**

Energy Consumption +/- % vs overall site production*

Volume Discharged back to environment (m3yr):

Volume used i.e not discharged to environment e.g. released as steam m3/yr Unaccounted for Water:

GroundwaterSurface water 5,060 53Public supply 53,670 61,717Recycled water

Total 58,730 61,770 -11.1% 44,469

17,196 m3, which is water to foul sewer or released as steam that is not metered.

* where consumption of water can be compared to overall site production please enter this information as percentage increase or decrease compared to the previous reporting year.** where site production information is available please enter percentage increase or decrease compared to previous year

Table R2 Water usage on site

When did the site carry out the most recent energy efficiency audit? Please list the recommendations in table 3 below

Is the site a member of any accredited programmes for reducing energy usage/water conservation such as the SEAI programme linked to the right? If yes please list them in additional information

Where Fuel Oil is used in boilers on site is the sulphur content compliant with licence conditions? Please state percentage in additional information

Table R1 Energy usage on site

Regular small audits also carried out throughout year. The dedicated Energy Group carry out forthnightly audits of electricity, gas and steam consumption versus production.

http://www.seai.ie/Your_Business/Large_Energy_Users/LIEN/



2


Total Landfill Incineration Recycled OtherHazardous (Tonnes) 1059.91 0 988.92 61.27 9.72Non-Hazardous (Tonnes) 151 18.35 0 132.65

Table R3 Waste Stream Summary

3


Date of audit RecommendationsDescription of Measures proposed Origin of measures

Predicted energy savings % Implementation date Responsibility Completion date

Status and comments

May-16

Install VSD pumps on IW water distribution system energy audit Energy Engineer

See EMP for more detail

May-16

Installation of local district heating network energy audit Energy Engineer


May-16

Installation of heat pump on cooling tower return energy audit Energy Engineer


May-16

Investigate renewables for electricity generation on-site

energy audit Energy EngineerSee EMP for more detail

Table R5: Power Generation: Where power is generated onsite (e.g. power generation facilities/food and drink industry)please complete the following informationUnit ID Unit ID Unit ID Unit ID Station Total

TechnologyPrimary FuelThermal EfficiencyUnit Date of CommissionTotal Starts for yearTotal Running TimeTotal Electricity Generated (GWH)House Load (GWH)KWH per Litre of Process WaterKWH per Litre of Total Water used on Site

Table R4: Energy Audit finding recommendations

1

Complaints and Incidents summary template Lic No: P0007-03 Year 2016


No

Date Category Other type (please specify)

Brief description of complaint (Free txt <20 words)

Corrective action< 20 words Resolution status Resolution date

Further information

SELECT SELECTSELECT SELECT

Total complaints open at start of reporting year 0Total new complaints received during reporting year 0Total complaints closed during reporting year 0Balance of complaints end of reporting year 0


Yes

What is an incident

Table 2 Incidents summary

Date of occurrence Incident nature Location of occurrenceIncident category*please refer to guidance Receptor Cause of incident

Other cause(please specify)

Activity in progress at time of incident Communication Occurrence

Corrective action<20 words

Preventative action <20 words Resolution status

Resolution date

Likelihood of reoccurence

06/01/2016 Breach of ELVLicenced discharge point (EP-WW-001) 1. Minor Sewer Other

Incorrect result report by external laboratory Normal activities EPA New

Anomaly result reported by external laboratory for suspended solids from WWTP - repeat result was the elv. N/A Complete SELECT

03/05/2016 Breach of ELVLicenced discharge point (EP-IN-001) 1. Minor Air Other

High dust and VOCs reported by EPA during EPA monitoring. Normal activities EPA New

Particulate monitoring method used during monitoring under review - may not be suitable for operating conditions.

None identified as yet. Ongoing SELECT

Total number of incidents current year 2Total number of incidents previous year 0% reduction/ increase 0

Complaints

Have you received any environmental complaints in the current reporting year? If yes please complete summary details of complaints received on site in table 1 below

Table 1 Complaints summary

Incidents

Have any incidents occurred on site in the current reporting year? Please list all incidents for current reporting year in Table 2 below

*For information on how to report and what constitutes an incident

http://www.epa.ie/downloads/advice/licensee/Guidance to licensees.pdf

1

WASTE SUMMARY Lic No: P0007-03 Year 2016

PRTR facility logon

Additional Information

1 No

2 SELECT

3 SELECT

Table 1 Details of waste accepted onto your site for recovery, disposal or treatment (do not include wastes generated at your site, as these will have been reported in your PRTR workbook)EWC code Description of waste

accepted Please enter an accurate and detailed description - which applies to relevant EWC code

Quantity of waste accepted in current reporting year (tonnes)

Reason for reduction/ increase

from previous reporting year

Packaging Content (%)- only applies if the waste

has a packaging component

European Waste Catalogue EWC codes European Waste Catalogue EWC codes

4 SELECT

5 SELECT

6 SELECT7 Do you have an odour management system in place for your facility? If no why? SELECT8 Do you maintain a sludge register on site? SELECT

Table 2 Waste type and tonnage-landfill only

Waste types permitted for disposal

Authorised/licenced annual intake for disposal (tpa)

Actual intake for disposal in reporting year (tpa)

Remaining licensed capacity at end of

reporting year (m3) Comments

Table 3 General information-Landfill only

Total disposal area occupied by waste

Lined disposal area occupied by waste

Unlined area

SELECT UNIT SELECT UNIT SELECT UNIT

Cell 8

Inert or non-hazardous Predicted date to cease landfilling

Licence permits asbestos

Is there a separate cell for asbestos?

Accepted asbestos in reporting year

Comments on liner type

SECTION D-TO BE COMPLETED BY LANDFILL SITES ONLY

Area ID Date landfilling commenced Date landfilling ceased Currently landfilling Private or Public Operated

Is all waste storage infrastructure as required by your licence and approved by the Agency in place? If no please list waste storage infrastructure required on site

Does your facility have relevant nuisance controls in place?

Disposal/Recovery or treatment operation carried out at your

site and the description of this operation

Quantity of waste remaining

on site at the end of reporting

year (tonnes)

Comments -

SECTION C-TO BE COMPLETED BY ALL WASTE FACILITIES (waste transfer stations, Composters, Material recovery facilities etc) EXCEPT LANDFILL SITES

Is all waste processing infrastructure as required by your licence and approved by the Agency in place? If no please list waste processing infrastructure required onsite

Did your site have any rejected consignments of waste in the current reporting year? If yes please give a brief explanation in the additional information

Was waste accepted onto your site that was generated outside the Republic of Ireland? If yes please state the quantity in tonnes in additional information

Licenced annual tonnage limit for your

site (total tonnes/annum)

Source of waste accepted Quantity of waste accepted in previous reporting year (tonnes)

Reduction/ Increase over

previous year +/ - %

SECTION A-PRTR ON SITE WASTE TREATMENT AND WASTE TRANSFERS TAB- TO BE COMPLETED BY ALL IPPC AND WASTE FACILITIES dropdown list click to see options

SECTION B- WASTE ACCEPTED ONTO SITE-TO BE COMPLETED BY ALL IPPC AND WASTE FACILITIES

Were any wastes accepted onto your site for recovery or disposal or treatment prior to recovery or disposal within the boundaries of your facility ?; (waste generated within your boundaries is to be captured through PRTR reporting)

If yes please enter details in table 1 below

http://aer.epa.ie/reporting/pgLogon.aspx

http://www.epa.ie/downloads/forms/wreport/nwr/EPA_waste_catalogue_hazard_list_2002.pdf



2

WASTE SUMMARY Lic No: P0007-03 Year 2016

Table 4 Environmental monitoring-landfill only Landfill Manual-Monitoring StandardsWas meterological monitoring in compliance with Landfill Directive (LD) standard in reporting year +

Was leachate monitored in compliance with LD standard in reporting year

Was Landfill Gas monitored in compliance with LD standard in reporting year

Was SW monitored in compliance with LD standard in reporting year

Have GW trigger levels been established

Were emission limit values agreed with the Agency (ELVs)

Was topography of the site surveyed in reporting year

Has the statement under S53(A)(5) of WMA been submitted in reporting year Comments

.+ please refer to Landfill Manual linked above for relevant Landfill Directive monitoring standardsTable 5 Capping-Landfill only

Area uncapped* Area with temporary cap

SELECT UNIT SELECT UNIT

*please note this includes daily cover areaTable 6 Leachate-Landfill only

9 Is leachate from your site treated in a Waste Water Treatment Plant? SELECT10 Is leachate released to surface water? If yes please complete leachate mass load information below SELECT

Volume of leachate in reporting year(m3) Leachate (BOD) mass load (kg/annum)

Leachate (COD) mass load (kg/annum)

Leachate (NH4) mass load (kg/annum)

Leachate (Chloride) mass load kg/annum Leachate treatment on-site

Specify type of leachate treatment Comments

Table 7 Landfill Gas-Landfill only

Gas Captured&Treated by LFG System m3 Power generated (MW / KWh) Used on-site or to national grid

Was surface emissions monitoring performed during the reporting

year? CommentsSELECT

Area with final cap to LD Standard m2 ha, a Area capped other

Area with waste that should be permanently capped to date under

licence What materials are used in the cap Comments

Please ensure that all information reported in the landfill gas section is consistent with the Landfill Gas Survey submitted in conjunction with PRTR returns

http://www.epa.ie/downloads/advice/licensee/epa landfill monitoring.pdf


APPENDIX 2

Composition of Waste Incinerated on-site 2016

Astellas Ireland Co. Ltd. Page 1 of 1 Appendix 1 IPPC Licence P0007-03 Waste Composition Report 2016

WASTE COMPOSITION 2016 Details of the composition of waste incinerated on-site in accordance with Schedule A.2

Waste Categories and Quantities for Acceptance at the on-site Incinerator during 2016 are

outlined below.

EWC Code Component Average Composition %v/v

07 05 01* Dimethylformamide

Triethylamine

Ethanol

Methanol

Ethyl acetate

Toluene

1,4 Dioxane

Inorganic Residue

Water

5.44

0.02

13.78

1.49

0.21

0.11

0.74

1.18

80.26

07 05 04* Dimethylformamide

Triethylamine

Ethanol

Methanol

Ethyl acetate

Toluene

1,4 Dioxane

Inorganic Residue

Water

1.17

1.11

30.11

36.78

4.52

4.03

12.16

0.21

9.48


APPENDIX 3

Environmental Management Programme Report 2016

Astellas Ireland Co., Ltd. Environmental Management Programme Annual Report

Year: 2016

Compiled By: Date: 24/03/2017 Approved By: Date: 27/03/2017

Page 1 of 24

Submitted to the Environmental Protection Agency under Condition 2.2.2.3 of the Industrial Emissions Licence, P0007-03. This document also includes the Pollution Emission Register (Condition 6.11) and details of the Public Information Programme (Condition 2.2.2.7). Astellas Ireland Co., Ltd. Damastown Road Damastown Industrial Park Dublin 15

Environmental Management Programme Report 2016

Astellas Ireland Co., Ltd. Environmental Management Programme Report 2016

Page 2 of 24

TABLE OF CONTENTS

Section Title Page 1 Environmental Management Programme – Annual Report

3

2 General Information

4

3 Pollution Emission Register/Pollutant Release Transfer Register – Annual Report

6

Appendix 1 Environmental Targets & Objectives 7

Appendix 2 Pollution Emission Register/Pollution Release Transfer Register Proposal 20

Appendix 3 Glossary of Terms 24


Page 3 of 24

1 ENVIRONMENTAL MANAGEMENT PROGRAMME – ANNUAL REPORT 1.1 Introduction

This is the twenty second annual report of the Environmental Management Programme (EMP) prepared in accordance with Condition 2.2.2.3 of IE Licence P0007-03. Details of the annual environmental objectives and targets are included in the Annual Environmental Report submitted to the EPA before March 31st each year, as per Conditions 2.2.2.3 and 11.9 of IE Licence P0007-03.

1.2 Progress Report

Details of progress made against targets set as part of a five-year plan and new targets set, including responsibilities, are contained in Appendix 1. The new targets included in the management programme are those discussed and agreed by senior management during the Annual Environmental Management Review.


Page 4 of 24

2 GENERAL INFORMATION 2.1 Company Activities Update

In 2005, Yamanouchi merged with the Japanese company Fujisawa. The merged entity adopted the new name Astellas and Yamanouchi Ireland Co., Ltd. will be known as Astellas Ireland Co., Ltd. (Dublin Plant) as and from October 1st 2005. Details contained in this Environmental Management Programme Report pertain to activities at the AICL Dublin Plant.

2.2 Environmental Standards

a) AICL successfully underwent a verification of data for EMAS in June 2016. As part of the verification an independent verifier accredited under the EU EMAS scheme independently validated the EMAS statement and data pertaining to AICL’s environmental performance.

b) AICL successfully underwent surveillance audits for ISO 14001 in February 2016 and August

2016. 2.3 Environmental Performance

a) AICL did not receive any environmental complaints during 2016. b) Details of AICL’s non-compliances are contained in the AER submitted to the Agency.

c) AICL continues to be committed to maintaining its good environmental performance and to

continual improvement, as required by the IE Licence, ISO14001 and EMAS. The production of the annual environmental statement of environmental performance as required by EMAS ensures that we communicate this commitment and our environmental performance publicly.

2.4 Communication Programme

It is AICL’s policy to communicate openly with all relevant parties, both internally and externally, in relation to environmental activities on-site. Information communicated includes current issues for AICL and future plans. Data and information relating to environmental operations and performance is freely available for review by interested parties at the Security Lodge and includes:

Annual Environmental Report EMAS Statements Emergency Operations Plan Environmental Impact Assessments


Page 5 of 24

2.5 Product Overview

AICL manufactures famotidine, mirabegron, solifenacin succinate and tamsulosin hydrochloride in separate dedicated production facilities. P2 was used in 2016 to manufacture solifenacin succinate – mirabegron was not manufactured in this plant during 2016. Due to market conditions, production in the famotidine plant is significantly reduced on previous years.

2.6 Corporate & Social Responsibility

AICL’s environmental performance is communicated by the issuance of the annual EMAS Environmental Statement to all personnel on-site, including permanent contractors. We also accommodate many visitors to the site annually. There were 46 visitors to AICL in 2016, including second and third level students and other interested parties. The tours incorporated the manufacturing plants and our environmental protection systems - information pertaining to our environmental management systems and details of our environmental performance were also communicated. As the focus of these tours is generally environmental, it demonstrates how environmental awareness in the general community has attained a higher profile over the last number of years.

Work experience is invaluable for those trying to get some level of experience before seeking full time employment. Astellas has a dedicated Work Experience Programme whereby Transition Year students from local secondary schools are placed in specific work areas to gain insight into how such roles operate on a day-to-day basis. Students from third level institutions were also accommodated on-site for 6-month placements – these placements are generally in the environmental/laboratory areas.


Page 6 of 24

3 POLLUTIONS EMISSION REGISTER (PER)/POLLUTANT RELEASE TRANSFER REGISTER (PRTR) – ANNUAL REPORT

3.1 Introduction

This is the twenty second annual report of the PER, now PRTR, to be generated by AICL as required under Condition 6.11 of IE Licence P0007-03.

3.2 Background Information

The PRTR is based on the PRTR Proposal as submitted to the EPA in March 2016 as part of the Annual Environmental Report and the new PRTR requirements. The PRTR Proposal for 2017 is included in Appendix 2 of this report – the proposal for 2017 does not differ to that proposed to the EPA in March 2016.

3.3 Progress Report

Previous PER reports have included data pertaining to toluene and methylene chloride. As nicardipine is no longer manufactured at this site and methylene chloride is not used in any other process, the current PRTR reports on Non-methane VOCs and Toluene. The PRTR reports were prepared in consultation with the Clean Technology Centre, using the same version of the spreadsheet employed to prepare data for the PRTR in previous years, with updates to accommodate the changes due to the introduction of the production of solifenacin succinate in 2005 and mirabegron in 2013.


Page 7 of 24

APPENDIX 1 Environmental Targets & Objectives – 5 Year Plan

2015 2016 2017 2018 2019 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4

Energy Review feasibility of utilizing photovoltaic panels for Warehouse Investigate the option of biomass boiler for hot water in Admin Investigate use of natural gas boiler for heat in Admin Perform steam audit Replace fluorescent tubes in MTC Building with LED Review suitability of using de-stratification fans in Warehouse Investigate the option of biomass boiler for Warehouse heating Replace fluorescent tubes in Engineering Building with LED Replace old air compressor with new efficient unit Replace hot water pumps in Admin and Warehouse Replace passing steam traps HVAC review - assess if VSD control on fans suitable Replace HVAC centrifugal fans with high efficiency plug fans Replace pumps on cooling tower water system Update Building Management System to allow for better M&T Replace calorifiers in Admin and Warehouse Installation of VSD on Cooling Tower network pumps Install VSD pumps on IW water distribution system Installation of local district heating network Installation of heat pump on cooling tower return Investigate renewable options for electricity generation on-site Water Conservation Shutdown P1 Purified Water System

Completed Objective Objective to be completed Objective cancelled Objective on-hold


Page 8 of 24

APPENDIX 1 Environmental Targets & Objectives – 5 Year Plan (continued)

2014 2015 2016 2017 2018 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Recycling Install additional segregation bins in Engineering Office Install additional segregation bins in QA Office Audit facility for plastic drum recycling Audit Panda recycling and disposal facilities Ecology Conduct survey of river Tolka Conduct survey of river Pinkeen Replant trees along new section of Pinkeen Clear variegated marginals from along Pinkeen Resume grazing in unused portion of site Plant wildflowers along berm in Contractor Car Park Plant additional trees in unused portion of site Set up beehives on-site Extend pathway along Pinkeen to allow staff walk along river Fugitive Emissions Improve N2 inertion on VE1390 – reduces fugitive emissions Replace breather valve on VE9600 to reduce N2 usage for inertion Efficiency of Raw Material Usage Remove blending operation of recovered material in famotidine Standardise weight of carbon used in famotidine process Use tail of raw material in future batches Improve N2 inertion on VE1390 – N2 savings Change management of product heel in P2 process Change MB process to make more product using same volume of solvent as current process

Completed Objective Objective to be completed Objective cancelled Objective on-hold


Page 9 of 24

APPENDIX 1 Environmental Targets & Objectives – 5 Year Plan (continued)

2014 2015 2016 2017 2018 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Communications Prepare EMAS Environmental Statement Organise Energy Awareness sessions Waste Management Dispose of all recovered R22 Audit Rehab Recycling Audit polystyrene recycling facility Assess alternatives for cardboard cups in canteen Improve waste segregation in office areas Audit Indaver Meath facility Audit Panda waste and recycling facilities Industrial Emissions Licence & Legal Compliance Perform QAL2/AST on CEMS Remove remaining air conditioning units containing R22 Routine Bund Integrity Testing Programme Perform hydrostatic testing on stormwater pipeline system Perform hydrostatic testing on foul sewer pipeline system Repair foul sewer drains (phase 1) Monitor P2 emissions for by-pass assessment (MB process) Re-line bund BU006 and re-test integrity Re-line bund BU001 and integrity test – new lining type Repair stormwater drains (phase 1) Repair stormwater drains (phase 2) Repair foul sewer drains (phase 2) Perform hydrostatic testing on process drain system Discuss shutdown of on-site incinerator with EPA Completed Objective Objective to be completed Objective cancelled Objective on-hold


Page 10 of 24

APPENDIX 1 Environmental Targets & Objectives

ENERGY MANAGEMENT & CONSERVATION Environmental Aspect Priority Significant

Objective Energy Usage - Investigate means for achieving reduction in energy usage and improvements in energy efficiency

EFF(EN)-001 Energy Usage High

Yes

TARGETS 2014 2015 2016 2017 2018 Responsibility Notes

2015 - Review feasibility of utilizing photovoltaic panels for Warehouse Complete Review

Complete Energy Support Engineer

This project has been reviewed and is included in the 5 year energy roadmap plan for completion in 2019/2020 when the local district heating project is complete.

2015 - Investigate the option of biomass boiler for hot water in Admin Complete Energy Support Engineer With the reduce market price for gas, it is not economically viable to

install a biomass boiler.

2015 - Investigate the feasibility of natural gas boiler for radiator system in Admin Complete Energy Support Engineer This project will not proceed, as the payback period is too long given

the current low gas prices.

2015 – Perform steam audit Complete Energy Support Engineer

2015 – Replace fluorescent tubes in MTC Building with LED Complete Energy Support Engineer

2016 – Review suitability of using de-stratification fans in Warehouse Complete Energy Support Engineer

The review of this project deemed it not viable at the moment – project shelved until other energy projects complete, when it can be reviewed again.

2016 – Investigate the option of a biomass boiler for Warehouse heating Complete Energy Support Engineer A biomass boiler will not be required when the local district heating

system is installed.

2016 – Replace old air compressor with new efficient unit Complete Energy Support Engineer

2016 – Replace fluorescent tubes in Engineering Building with LED Complete Energy Support Engineer

2016 – Change hot water system pumps in Admin and Warehouse Complete Energy Support Engineer

2016 – Replacement of passing steam traps Complete Energy Support Engineer

2016 – Review HVAC to assess if VSD can be put on fans. Complete Energy Support Engineer VSD to be installed as part of larger project for upgrade of HVAC

system in 2018/2019.


Page 11 of 24


ENERGY MANAGEMENT & CONSERVATION Environmental Aspect Priority Significant

Objective Energy Usage - Investigate means for achieving reduction in energy usage and improvements in energy efficiency

EFF(EN)-001 Energy Usage High

Yes

TARGETS 2017 2018 2019 Responsibility Notes

2017 – Replace HVAC centrifugal fans with high efficiency plug fans New Target New Target Energy Support Engineer This is a large project over a 2 year period.

2017 – Replace pumps on cooling tower water system New Target Energy Support Engineer New VSD controlled pumps and overall system control strategy to be installed in

2017.

2017 – Update Building Management System to allow for better M&T

Postponed to 2018

Energy Support Engineer Project postponed to 2018 to allow team to focus on local district heating system.

2017 – Replace calorifiers in Admin and Warehouse with more efficient units On hold Energy Support Engineer These units may not be required when the local district heating system is installed –

this project will be reviewed after installation of the local district heating system.

2017 - Installation of VSD on Cooling Tower network pumps New Target Energy Support Engineer

2018 - Install VSD pumps on IW water distribution system New Target Energy Support Engineer

2018 - Installation of local district heating network New Target Energy Support Engineer

A review of heat losses on-site has identified an opportunity to collect waste heat into a local district heating network. The project involves installing a new pipe ring around the site, which can be used to redistribute the recovered heat losses. Heat losses from main boiler flue, air compressors and HVAC outlet can be used as a heat source for HVAC inlet.

2018 - Installation of heat pump on cooling tower return New Target Energy Support Engineer

2019 – Investigate renewables for electricity generation on-site New Target Energy Support Engineer


Page 12 of 24


WATER MANAGEMENT & CONSERVATION Environmental Aspect Priority Significant

Objective Investigate means for reducing water usage on-site EFF(WAT)-001 Use of Potable Mains water High

Yes

TARGETS 2017 Responsibility Notes

2017 – Shutdown P1 Purified Water System New Target

Environmental Operations P1 Production Personnel

System will not be required for P1 production during 2017 – this should make some saving in water consumption.


Page 13 of 24


WASTE Environmental Aspect Priority Significant

Objective Identify opportunities for waste reduction and ensure waste is disposed of appropriately

EFF(WAS)-001Management of Waste on-site EFF(WAS)-002 Management of Waste off-site EFF(WAS)-004 Landfilled Waste

Low Low

Medium

Yes Yes No

TARGETS 2011 2012 2013 2014 2015 2016 2017 Responsibility Notes

On-going - Improve waste segregation in office areas

On-going Target

On-going Target

On-going Target

On-going Target

EHS Lead ADI Site Manager

2015 - Additional bins put into QA Office. 2016 – Additional bins put into Engineer’s Office and Project Office.

2014 - Audit Rehab Recycling Complete EHS Lead

2015 – Audit polystyrene recycling facility Complete EHS Lead

2015 – Dispose of recovered R22 Postponed to 2016

Postponed to 2017 EHS Lead

Postponed to 2017, as decision to be made about replacement of two small units containing R22.

2015 – Assess alternatives for cardboard cups in canteen for takeout drinks On-going On-going EHS Lead Cup trialled in 2015 was deemed too heavy –

alternatives to be reviewed in 2016.

2016 – Audit Indaver Meath facility for disposal of packaged hazardous waste

Complete EHS Lead

Facility is licensed to accept some hazardous waste with specific EWC code. Some of AICL’s waste is suitable for disposal in Indaver Meath, which reduces CO2 emissions by not shipping this waste to continental Europe.

2017 – Audit Panda disposal facilities Complete EHS Lead Disposal facilities audited following merger of Panda and Greenstar.


Page 14 of 24


RECYCLING Environmental Aspect Priority Significant Objective Recycle as many waste streams as possible to reduce

waste for landfill EFF(WAS)-004 Landfilled Waste Medium No

TARGETS 2014 2015 2016 2017 Responsibility Notes

2014 – Audit facility for plastic drum recycling Cancelled

EHS Lead This audit was not carried out, as fewer raw materials are delivered to the site in plastic drums, thus the number available for recycling has dramatically reduced.

2015 – Install segregation bins in QA office Complete EHS Lead Recycling bins installed in QA office.

2016 – Install additional recycling bins in Engineering office

Complete EHS Lead Recycling bins installed in Engineering office area and Project Office area.

2017 – Audit Panda recycling facilities Complete EHS Lead Recycling facilities audited following merger of Panda and Greenstar.


Page 15 of 24


IPPC LICENCE & LEGAL COMPLIANCE Environmental Aspect Priority Significant

Objective Maintain full compliance with legal and other requirements

EFF(AIR)-008 Licenced Air Emission Points EFF(WAT)-005 Licenced Water Emission Points

Medium Medium

No No

TARGET 2014 2015 2016 2017 2018 Responsibility Notes

On-going – Perform QAL2 on CEMS Not

complete Complete

Site Support Engineer QAL2 could not be completed during 2015, as incinerator was not operational at scheduled time of testing.

On-going – Routine bund testing programme Complete New target Team Leader - Environmental Operations

2014 – Perform Annual Surveillance Test on CEMS Complete Site Support Engineer

2014 – Re-line bund BU006 and re-test integrity Complete Facilities Engineering

2015 – Re-line bund BU001 with new system of lining – integrity test afterwards Postponed

to 2016 Complete

Facilities Engineering Postponed to 2016 due to repair works required

in 2015 on another bund which failed integrity.

2015 – Remove two small air conditioning units containing R22 from Warehouse Not

complete

HVAC Engineer Units were not replaced, as the need for this cold store in future is under review.

2015 – Perform hydrostatic testing on foul sewer system Complete Facilities Engineering

2016 – Repairs to foul sewer drains (Phase 1) Complete Facilities Engineering

2016 – Perform hydrostatic testing on process drain system Complete Facilities Engineering

2016 – Repairs to stormwater drains (Phase 1) Complete Facilities Engineering

2017 – Perform hydrostatic testing on stormwater drains New target Facilities Engineering

2017 – Repairs to stormwater drains (Phase 2) New target Facilities Engineering

2017 – Repair foul sewer drains (Phase 2) Complete Facilities Engineering

2017 – Discuss shutdown of on-site incinerator with EPA New target EHS Lead

2018 – Perform hydrostatic testing on foul sewer system New target EHS Lead


Page 16 of 24


ECOLOGY Environmental Aspect Priority Significant

Objective Conservation of Nature EFF(WAT)-003 Contamination of Ecosystem Low Yes

TARGETS 2011 2012 2013 2014 2015 2016 2017 Responsibility Notes

On-going - Conduct river survey of Pinkeen and Tolka

Complete

Complete

Complete Senior

Environmental Chemist

2011 – Perform survey of full length of Pinkeen on-site

Deferred to 2012 Complete

Complete

Senior Environmental Chemist

Check ecology of new section of river after diversion project in 2008. Deferred to 2012 to be carried out with Tolka survey.

2011 – Replant trees along new section of Pinkeen that did not take when first planted.

Deferred to 2012

Deferred to 2013

Complete

Senior Environmental Chemist

Planting was not carried out in 2011 bare rooted season, as there was not enough rainfall to sustain the trees. Options for watering trees to be considered for 2012/2013 bare rooted season to ensure trees survive.

2014 – Clear variegated marginals from along Pinkeen Postponed

to 2016 Deferred

to 2017 EHS lead Variegated marginals were very difficult to distinguish from other marginals – removal of these will be trialled in 2017.

2014 – Plant wildflowers along berm in Contractor Car Park Complete EHS Lead

2014 – Resume grazing on unused portion of site Complete Complete EHS Lead

2016 – Set up beehive on-site Complete EHS Lead Beehives will be kept on-site during 2017.

2016 – Extend pathway along Pinkeen to allow staff walk along river. Complete EHS Lead


Page 17 of 24


FUGITIVE EMISSIONS Environmental Aspect Priority Significant

Objective Minimise fugitive losses EFF(AIR)-004 Fugitive Emissions Low No

TARGETS 2015 2016 2017 Responsibility Notes

2015 – Upgrade valves for N2 inertion of VE1390 Complete

Project Engineer Reducing the valve size into this vessel will make the inertion of this vessel more efficient, thereby reducing the volume of N2 required for inertion and reducing the potential to generate fugitive losses of ethanol.

2017 – Replace breather valve on VE9600 to reduce N2 usage during inertion New

Target Project Engineer


Page 18 of 24


RAW MATERIAL USAGE/EFFICIENCY Environmental Aspect Priority Significant

Objective Efficient use of raw materials EFF(MAT)-005 Low No

TARGETS 2014 2015 2016 2017 Responsibility Notes

2014 – Remove blending operation of recovered material in famotidine process Complete MTC Chemist Removal of this process will save energy associated with the

blending process.

2014 – Standardise weight of carbon used in famotidine process Complete MTC Chemist

2015 - Change management of product heel in P2 process Complete MTC Chemist

2015 – Upgrade valves for N2 inertion of VE1390 Complete

Project Engineer Reducing the valve size into this vessel reduces the volume of N2 required for inertion, which reduces the potential to generate fugitive losses of ethanol.

2015 – Re-use tail of a raw material in MB process in subsequent batches ( previously disposed of) Complete MTC Chemist

2017 – Change MB process to allow for higher production volumes using same amount of solvent On hold MTC Chemist This project is on hold until Corporate approval given.

2017 - Installation of N2 flowmeters in P2 and P3 plants

New target Project Engineer

The N2 usage recorded by these flowmeters will be trended on the BMS to review for detection of leaks and sustain low usage levels on an on-going basis.


Page 19 of 24


COMMUNICATIONS Environmental Aspect Priority Significant

Objective Maintain high level of environmental awareness N/A N/A N/A

TARGETS 2014 2015 2016 2017 2018 Responsibility Notes

2014 - Prepare interim EMAS Environmental Statement Complete EHS Lead

2014 – Organise Energy Awareness sessions for staff on-site Postponed to 2015 Complete EHS Lead Time did not permit this to be done in

2014.

2015 – Prepare full EMAS Environmental Statement Complete EHS Lead

2016 – Prepare interim EMAS Environmental Statement Complete EHS Lead

2017 – Prepare ínterim EMAS Environmental Statement New Target EHS Lead

2018 – Prepare full EMAS Environmental Statement New Target EHS Lead


Page 20 of 24

APPENDIX 2 Pollution Emission Register/Pollution Release Transfer Register Proposal

Preparation of Solvent Mass Balances Summary This proposal outlines the methodology to be used in generating a Pollution Release Transfer Register (PRTR) for Astellas Ireland Co., Ltd. An outline of the presentation of the final results will also be produced. In addition, information to be gathered, methods of calculation or estimation and interpretation of figures will be discussed. Introduction The PRTR is a register of releases of materials to the various media and provides a basis for long term environmental management planning. The PRTR should be used to indicate areas of environmental concern and help in developing the Environmental Management Programme. Condition 6.11 of the IE Licence stipulates: 6.11 Pollution Emission Register

The licensee shall prepare and maintain a PER for the site. The substances to be included in the PER shall be agreed by the Agency each year by reference to the list specified in the Agency’s AER Guidance Note. The PER shall be prepared in accordance with any relevant guidelines issued by the Agency and shall be submitted as part of the AER.

Following review of the ‘Guidance Notes for Annual Environmental Reports’, section 4.5 Pollution Emission Register (PER) and Appendix II, AICL have previously identified two substances as outlined in Appendix II to be included in the PRTR. The candidate substances for the PRTR were toluene and dichloromethane (methylene chloride). Both of these substances were used in the manufacture of nicardipine hydrochloride, which ceased in 2003. A new product, solifenacin was manufactured in this plant in 2005, thus, toluene and Non-methane VOCs were reported for 2005 and are reported for 2016. It is planned to report toluene and Non-methane VOCs for 2017. The PRTR for any given year will be submitted to the Agency in the subsequent year as part of the Annual Environmental Report.


Page 21 of 24

Pollution Release Transfer Register (PRTR) DATA For each PRTR substance, mass quantities will be determined for the amount discharged to air, water and land, as well as the total usage and the recycle or recovery rate. In particular, the specific areas that will be investigated to generate the PER data will include some or all of the following:

Fresh Solvent Virgin solvent entering the site or process

Recovered Solvent Solvent recovery on-site

Change in Inventory The net change in inventory levels between the start and end of balance period

Point Sources Waste Water Loss discharged with final effluent

Building Ventilation Landfill Quantity of substance sent to landfill

Fugitive Emissions Losses from external process components

(Solvents) in product Material sent with final product

Surface water Incineration On-site and off-site

Tank losses Miscellaneous Includes material in spent oils, filter etc.


Page 22 of 24

A schematic diagram of the inputs and outputs is shown in Figure 1. In many cases, engineering estimates will be required and, when used, will be clearly explained. Other information required to generate the PER tables, such as number of batches, solvent recovery rates and general site specific operations will be explained at the outset. Data Determination The data for the PRTR will be obtained using several different methods. These include:

• direct determination by sampling and analysis • engineering calculations and software • material balance

In some cases, for example, fugitive emission determinations, a combination of both direct analytical measurements and engineering correlations would be used to obtain an annual mass emission rate. The monitoring data required under the Industrial Emissions Licence will be used to generate some of the PRTR figures. A simple methodology is in place to gather all the data required for the PRTR.

FIGURE 1 - SCHEMATIC OF INPUT-OUTPUT DIAGRAM

Tank Losses

PROCESS

Re-Used Drains

Waste Water Treatment Plant

Fugitive Emissions

Ventilation

Landfill

Miscellaneous

Surface Water

Final Effluent

New Solvent

Incineration

Point Sources

Tanks

Drums


Page 23 of 24

Quantification techniques for some of the main areas are briefly outlined below; Fresh Solvent All tanker deliveries are determined by delivery inventories. Drum material is

determined based on a number of drums delivered.

Inventory Change All storage tanks quantities are determined using level gauges dips or load cells.

Recovered Solvent The quantity of recovered material is determined from process operating records and recovered solvent tank levels.

Point Sources IPPC monitoring requirements will determine emissions from point sources.

Waste Water The effluent from the waste water system will be monitored to establish the emission levels.

Building Ventilation Fugitive Emissions A study has been carried out which quantified the magnitude of fugitive

emissions to air.

Tank Losses Software, developed by the US EPA has been used to estimate tank losses.

Final Report The report will consist of an overview on how the data was collected, including techniques, calculations, estimates or software used to obtain some of the data. A short description of the site operations, recovery and waste treatment methods and other important details will be outlined at the outset. The data will be included in the electronic submission to the EPA.


Page 24 of 24

APPENDIX 3 – GLOSSARY OF TERMS

AER Annual Environmental Report AICL Astellas Ireland Co., Ltd. AST Annual Surveillance Test BMS Building Management System CEMS Continuous Emission Monitoring System CTC Clean Technology Centre

EMP Environmental Management Programme EMAS Eco Management & Audit Scheme EMP Environmental Management Programme

EMS Environmental Management System

EPA Environmental Protection Agency EU European Union HVAC Heating and Ventilation Control

IE Industrial Emissions

PER Pollution Emissions Register PRTR Pollutant Release Transfer Register

SOP Standard Operating Procedure VOC Volatile Organic Compounds WEEE Waste Electrical & Electronic Equipment

WWTP Waste Water Treatment Plant


APPENDIX 4

Pollutant Release Transfer Register Report 2016

3

PRTR Report

for organic solvent related pollutants

Astellas Ireland Co., Ltd.

March 2017

Prepared by:

Eileen O’Leary Clean Technology Centre

1 INTRODUCTION

Astellas Ireland has identified the PRTR pollutants that are relevant to the site and include PCDDs/PCDFs, particulates to air, chlorides to sewer, etc. However, this report is only in relation to organic solvents. In terms of organic solvents, the only named PRTR substance relevant to the site is toluene. There has been no methylene chloride used since 2004. Ethyl chloroformate was also previously used but this is no longer the case. Non-methane volatile organic compounds (NMVOCs) are also reported as a PRTR pollutant. NMVOCs encompass all volatile organic compounds in use at the site: acetic acid, 1,4-dioxane, DMF, ethanol, ethyl acetate, methanol, and TEA.

2 PRTR METHODOLOGY FOR NMVOCS

The values for NMVOCs and Toluene for the PRTR have been calculated with regard to the EU guidance document1. Relevant terms for the site are as follows:

Releases to Air Outputs to air are from licensed emission sources and fugitive emission sources. Licensed Air Emissions The licensed emissions are:

- Incinerator - P1 Scrubber - P1-FCA Scrubber, but this did not operate in 2016 - P2 Scrubber - P3 Scrubber

Method: Measurement (M) – for the scrubbers. The licence does not specify a method for the scrubbers - gas chromatography is used. TOC is continuously monitored on the incinerator and apportioned to individual solvents based on amounts of solvent incinerated. Solvent incinerated is quantified based on volumes transferred, feed tank sampling, and changes in incinerator feed tank inventories. The waste that is sent off-site for disposal is also subtracted.

Fugitive Air Emissions Fugitive emissions were originally identified and quantified in 1997, while tank emissions were updated in 2013. Fugitive emissions include: - Bulk storage and waste tank storage fugitive emissions estimates were re-done in 2013 using USEPA

TANKS software and were then scaled based on solvent throughput in 2016. - Waste water treatment plant air emissions were estimated in 1997. Percentages stripped are then used

annually with individual solvent amounts sent to the waste water treatment plant for the year in question to determine solvent that is stripped to air.

- Certain process and building vent emissions. Measured in 1997 – scaled annually based on solvent throughput for the year in question.

- External process component emissions. A percentage of external process components were measured in 1997. Emissions are then scaled annually based on solvent throughput.

Method: Measurement (M) Other (OTH) – The figures measured or estimated during the fugitive emissions study have been adjusted, based on either solvent usage or number of batches, and utilised to produce emissions figures for 2016.

There were no accidental emissions in 2016 related to NMVOCs. Method Reported: For NMVOCs, the scrubbers are once again the top source of air emissions. Hence, since these are estimated through measurements, “Measurement (M) Other (OTH)” is the method that is reported in the PRTR form for NMVOCs.

1 European Commission, Guidance Document for the implementation of the European

PRTR, May 2006.

For toluene, fugitive emissions from the building vents are the largest source of air emissions in 2016. Since historical measurement scaled for solvent throughput has been used, “Measurement (M) Other (OTH)” is the method that is reported in the PRTR form for toluene.

Releases to Sewer Periodic monitoring of the effluent is carried out for solvent content even though the licence does not actually specify such a requirement. Analysis is via gas chromatography. The only solvent detected was 1,4-dioxane in 2012 – this value has been used as a worst case. Method Used: Effluent: Measurement (M) (OTH) gas chromatography

PRTR Categories not relevant to the site The following are not relevant to the site from the point of view of organic solvents:

- Releases to waters.

- Releases to land.

PRTR RESULTS FOR 2016

RELEASES TO AIR SECTION A : SECTOR SPECIFIC PRTR POLLUTANTS

POLLUTANT METHOD

Method Used

EP-IN-001

Incin-erator

P1 Scrubber

P1 FCA Scrubber

P2 Scrubber

P3 Scrubber

No. Annex

II Name

M/C/E

Code

Designation or Description

Emission Point 1

Emission Point 2

Emission Point 3

Emission Point 4

Emission Point 5

7 NMVOCs M OTH GC mass spec. 31 44 0 10 791

73 Toluene M OTH

Measured fugitive emissions scaled up based on usage 0 0 0 10 105

QUANTITY

T (Total) KG/Year

A (Accidental) KG/Year

F (Fugitive) KG/Year

NMVOCs 2,444 0 1,568 Toluene 368 0 253

RELEASES TO WASTEWATER OR SEWER SECTION A : PRTR POLLUTANTS

POLLUTANT METHOD QUANTITY Method Used No. Annex II Name

M/C/E Code

Designation or Description

Emission Point 1

T (Total) KG/Year



73 Toluene M OTH gas chromatography 0 0 0 0

7 NMVOCs M OTH gas chromatography 0.9 0.9 0 0


APPENDIX 5

Electronic PRTR printed sheets

| PRTR# : P0007 | Facility Name : Astellas Ireland Company Limited | Filename : P0007_2016.xlsm | Return Year : 2016 | 3316 28/03/2017 23:59

Guidance to completing the PRTR workbook

Version 1.1.19REFERENCE YEAR 2016

1. FACILITY IDENTIFICATIONParent Company Name Astellas Ireland Company Limited

Facility Name Astellas Ireland Company LimitedPRTR Identification Number P0007

Licence Number P0007-03

Classes of ActivityNo. class_name

- Refer to PRTR class activities below

Address 1 Dublin PlantAddress 2 Damastown RoadAddress 3 Damastown Industrial EstateAddress 4 Mulhuddart, Dublin 15

DublinCountry Ireland

Coordinates of Location -6.421645222 53.41250108River Basin District IEEA

NACE Code 2110Main Economic Activity Manufacture of basic pharmaceutical products

AER Returns Contact Name Clodagh EttarhAER Returns Contact Email Address [email protected]

AER Returns Contact Position EHS LeadAER Returns Contact Telephone Number 01 8030800

AER Returns Contact Mobile Phone NumberAER Returns Contact Fax Number 01 8030801

Production Volume 16.31Production Volume Units Tonne

Number of Installations 1Number of Operating Hours in Year 0

Number of Employees 78User Feedback/Comments Particulates for EP-IN-001, EP-P1-001, EP-P2-001, EP-UT-001 and EP-UT-002 lower than

2015 due to lower averages. Dioxins for EP-IN-001 higher than 2015 due to higher average. NOx for EP-UT-001 and EP-UT-002 higher than 2015 due to higher annual average.

Web Address

2. PRTR CLASS ACTIVITIESActivity Number Activity Name

4(e)Installations using a chemical or biological process for the production on an industrial scale of basic pharmaceutical products

50.1 General

3. SOLVENTS REGULATIONS (S.I. No. 543 of 2002)Is it applicable? No

Have you been granted an exemption ?If applicable which activity class applies (as per

Schedule 2 of the regulations) ?Is the reduction scheme compliance route being

used ?

4. WASTE IMPORTED/ACCEPTED ONTO SITE Guidance on waste imported/accepted onto siteDo you import/accept waste onto your site for on-

site treatment (either recovery or disposal activities) ? No

This question is only applicable if you are an IPPC or Quarry site

PRTR Returns Workbook

http://www.epa.ie/downloads/advice/aerprtr/completinguploadingtheprtrworkbook/#d.en.30355�

http://www.epa.ie/downloads/advice/aerprtr/completinguploadingtheprtrworkbook/name,40732,en.html

4.1 RELEASES TO AIR Link to previous years emissions data | PRTR# : P0007 | Facility Name : Astellas Ireland Company Limited | Filename : P0007_2016.xlsm | Return Year : 2016 | 28/03/2017 23:598 20 28 30 38 40 6 12 6 12 6 12 40

SECTION A : SECTOR SPECIFIC PRTR POLLUTANTSPlease enter all quantities in this section in KGs

QUANTITYEP-IN-001 EP-UT-001 EP-UT-002 EP-P1-001 EP-P1-002 EP-P2-001 EP-P3-001

No. Annex II Name M/C/E Method Code Designation or Description Emission Point 1 Emission Point 2 Emission Point 3 Emission Point 4 Emission Point 5 Emission Point 6 Emission Point 7T (Total) KG/Year



17 Arsenic and compounds (as As) M EN 14385:2004 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.018 Cadmium and compounds (as Cd) M EN 14385:2004 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.080 Chlorine and inorganic compounds (as HCl) M EN 1911-1 to 3:2003 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.019 Chromium and compounds (as Cr) M EN 14385:2004 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.020 Copper and compounds (as Cu) M EN 14385:2004 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.023 Lead and compounds (as Pb) M EN 14385:2004 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.021 Mercury and compounds (as Hg) M EN 14385:2004 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.022 Nickel and compounds (as Ni) M EN 14385:2004 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0

08 Nitrogen oxides (NOx/NO2) M ALT

CEMS for EP-IN-001 & EN15058:2006 for EP-UT-002 and EP-UT-002. 525.0 553.0 594.0 0.0 0.0 0.0 0.0 1672.0 0.0 0.0

07 Non-methane volatile organic compounds (NMVOC) M EN 13649:2001 31.0 0.0 0.0 44.0 0.0 10.0 791.0 2444.0 0.0 1568.047 PCDD + PCDF (dioxins + furans)(as Teq) M EN 1948-1 to3:2003 0.000000015 0.0 0.0 0.0 0.0 0.0 0.0 0.000000015 0.0 0.0

11 Sulphur oxides (SOx/SO2) M ALT

CEMS for EP-IN-001 & TGN21 for EP-UT-002 and EP-UT-002. 0.0 25.8 19.5 0.0 0.0 0.0 0.0 45.3 0.0 0.0

04 Hydro-fluorocarbons (HFCs) E ESTIMATEBased on refrigerant top ups required in 2016. 0.0 0.0 0.0 0.0 0.0 0.0 0.0 37.7 0.0 37.7

* Select a row by double-clicking on the Pollutant Name (Column B) then click the delete button

SECTION B : REMAINING PRTR POLLUTANTSPlease enter all quantities in this section in KGs


No. Annex II Name M/C/E Method Code Designation or Description Emission Point 1 Emission Point 2 Emission Point 3 Emission Point 4 Emission Point 5 Emission Point 6 Emission Point 7T (Total) KG/Year



02 Carbon monoxide (CO) M ALTCEMS for EP-IN-001 and EN15058:2006 for boilers. 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0

84 Fluorine and inorganic compounds (as HF) M ALT EN15713:2006 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0

73 Toluene M EN 13649:2001Measured and scaled up based on usage. 0.0 0.0 0.0 0.0 0.0 10.0 105.0 368.0 0.0 253.0


SECTION C : REMAINING POLLUTANT EMISSIONS (As required in your Licence)Please enter all quantities in this section in KGs


Pollutant No. Name M/C/E Method Code Designation or Description Emission Point 1 Emission Point 2 Emission Point 3 Emission Point 4 Emission Point 5 Emission Point 6 Emission Point 7T (Total) KG/Year



210 Dust M ALT

Measured emission scaled up based on usage, EP-IN-001 based on CEMS and scrubbers based on EN13284-1:2002 10.0 2.6 2.8 2.1 0.0 9.3 8.6 35.4 0.0 0.0

233 Thallium compounds M EN 14385:2004 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0214 Hydrogen bromide M OTH US EPA Method 26/26A 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0


Additional Data Requested from Landfill operators

Landfill: Astellas Ireland Company Limited

Please enter summary data on the quantities of methane flared and / or utilised

additional_pollutant_no T (Total) kg/Year M/C/E Method CodeDesignation or

DescriptionFacility Total Capacity

m3 per hourTotal estimated methane generation (as per

site model) 0.0 N/AMethane flared 0.0 0.0 (Total Flaring Capacity)

Methane utilised in engine/s 0.0 0.0 (Total Utilising Capacity)Net methane emission (as reported in Section

A above) 0.0 N/A

Method Used

Method Used

RELEASES TO AIRPOLLUTANT METHOD

Method Used

POLLUTANT

RELEASES TO AIR

RELEASES TO AIRMETHOD

POLLUTANT METHODMethod Used

For the purposes of the National Inventory on Greenhouse Gases, landfill operators are requested to provide summary data on landfill gas (Methane) flared or utilised on their facilities to accompany the figures for total methane generated. Operators should only report their Net methane (CH4) emission to the environment under T(total) KG/yr for Section A: Sector specific PRTR pollutants above. Please complete the table below:

4.2 RELEASES TO WATERS Link to previous years emissions data | PRTR# : P0007 | Facility Name : Astellas Ireland Company Limited | Filename : P0007_2016.xlsm | Return Year : 2016 | 28/03/2017 23:598 8 16 16 24 24 6 6 6 6

SECTION A : SECTOR SPECIFIC PRTR POLLUTANTS Data on ambient monitoring of storm/surface water or groundwater, conducted as part of your licence requirements, should NOT be submitted under AER / PRTR Reporting as this only concerns Relea Please enter all quantities in this section in KGs

QUANTITY

No. Annex II Name M/C/E Method Code Designation or Description Emission Point 1 T (Total) KG/Year A (Accidental) KG/Year F (Fugitive) KG/Year0.0 0.0 0.0 0.0


SECTION B : REMAINING PRTR POLLUTANTSPlease enter all quantities in this section in KGs

QUANTITY

No. Annex II Name M/C/E Method Code Designation or Description Emission Point 1 T (Total) KG/Year A (Accidental) KG/Year F (Fugitive) KG/Year0.0 0.0 0.0 0.0


SECTION C : REMAINING POLLUTANT EMISSIONS (as required in your Licence)Please enter all quantities in this section in KGs

QUANTITY

Pollutant No. Name M/C/E Method Code Designation or Description Emission Point 1 T (Total) KG/Year A (Accidental) KG/Year F (Fugitive) KG/Year0.0 0.0 0.0 0.0


RELEASES TO WATERS

Method Used

RELEASES TO WATERS

RELEASES TO WATERS

Method Used

POLLUTANTMethod Used

POLLUTANT

POLLUTANT

4.3 RELEASES TO WASTEWATER OR SEWER Link to previous years emissions data | PRTR# : P0007 | Facility Name : Astellas Ireland Company Limited | Filename : P0007_2016.xlsm | R 28/03/2017 23:598 22 30 33 6 6 6 6 33

SECTION A : PRTR POLLUTANTSPlease enter all quantities in this section in KGs

QUANTITYEP-WW-001

No. Annex II Name M/C/E Method Code Designation or Description Emission Point 1 T (Total) KG/Year A (Accidental) KG/Year F (Fugitive) KG/Year06 Ammonia (NH3) M OTH BS 2690 Part 7 61.0 61.0 0.0 0.0

17 Arsenic and compounds (as As) M OTHAPHA/AWWA Method 3125B 0.0 0.0 0.0 0.0

18 Cadmium and compounds (as Cd) M OTHAPHA/AWWA Method 3125B 0.0 0.0 0.0 0.0

19 Chromium and compounds (as Cr) M OTHAPHA/AWWA Method 3125B 0.0 0.0 0.0 0.0

20 Copper and compounds (as Cu) M OTHAPHA/AWWA Method 3125B 0.0 0.0 0.0 0.0

23 Lead and compounds (as Pb) M OTHAPHA/AWWA Method 3125B 0.0 0.0 0.0 0.0

21 Mercury and compounds (as Hg) M OTHAPHA/AWWA Method 3125B 0.0 0.0 0.0 0.0

22 Nickel and compounds (as Ni) M OTHAPHA/AWWA Method 3125B 0.0 0.0 0.0 0.0

24 Zinc and compounds (as Zn) M OTHAPHA/AWWA Method 3125B 0.0 0.0 0.0 0.0

79 Chlorides (as Cl) M OTHEPA Methods 325.1 & 325.2 33781.0 33781.0 0.0 0.0

07 Non-methane volatile organic compounds (NMVOC) M OTHGCMS and scale up based on volume 0.9 0.9 0.0 0.0

47 PCDD + PCDF (dioxins + furans)(as Teq) M ISO 18073:2004 0.000000011 0.000000011 0.0 0.0

73 Toluene M OTHGCMS and scale up based on volume 0.0 0.0 0.0 0.0

76 Total organic carbon (TOC) (as total C or COD/3) M ALT ISO 6060:1989 2889.0 2889.0 0.0 0.071 Phenols (as total C) M OTH HPLC 0.0 0.0 0.0 0.0


SECTION B : REMAINING POLLUTANT EMISSIONS (as required in your Licence)Please enter all quantities in this section in KGs

QUANTITYEP-WW-001

Pollutant No. Name M/C/E Method Code Designation or Description Emission Point 1 T (Total) KG/Year A (Accidental) KG/Year F (Fugitive) KG/Year

303 BOD M OTH

MEWAM BOD5 2nd Ed, Method 5210B AWWA/APHA, 20th Ed. 914.5 914.5 0.0 0.0

306 COD M ALT ISO 6060-1898 8668.0 8668.0 0.0 0.0

343 Sulphate M OTHEPA Methods 325.1 & 325.2 11179.0 11179.0 0.0 0.0

240 Suspended Solids M OTH

Method 2540D, AWWA/APHA 20th Ed, BS EN 872 5280.0 5280.0 0.0 0.0


OFFSITE TRANSFER OF POLLUTANTS DESTINED FOR WASTE-WATER TREATMENT OR SEWER

OFFSITE TRANSFER OF POLLUTANTS DESTINED FOR WASTE-WATER TREATMENT OR SEWER

Method Used

Method Used

POLLUTANT METHOD

POLLUTANT METHOD

4.4 RELEASES TO LAND Link to previous years emissions data | PRTR# : P0007 | Facility Name : Astellas Ireland Company Limited | Filename : P0007_2016.xlsm | Return Year : 2016 | 28/03/2017 23:598 8 16 16 6 6 6 6

SECTION A : PRTR POLLUTANTSPlease enter all quantities in this section in KGs

QUANTITY

No. Annex II Name M/C/E Method Code Designation or Description Emission Point 1 T (Total) KG/Year A (Accidental) KG/Year0.0 0.0 0.0


SECTION B : REMAINING POLLUTANT EMISSIONS (as required in your Licence)Please enter all quantities in this section in KGs

QUANTITY

Pollutant No. Name M/C/E Method Code Designation or Description Emission Point 1 T (Total) KG/Year A (Accidental) KG/Year0.0 0.0 0.0



RELEASES TO LAND

RELEASES TO LAND


5. ONSITE TREATMENT & OFFSITE TRANSFERS OF WASTE | PRTR# : P0007 | Facility Name : Astellas Ireland Company Limited | Filename : P0007_2016.xlsm | Return Year : 2016 | 28/03/2017 23:595 38 Please enter all quantities on this sheet in Tonnes 0

Quantity (Tonnes per

Year)

Haz Waste : Name and Licence/Permit No of Next

Destination Facility Non Haz Waste: Name and Licence/Permit No of

Recover/Disposer

Haz Waste : Address of Next Destination Facility

Non Haz Waste: Address of Recover/Disposer

Name and License / Permit No. and Address of Final Recoverer /

Disposer (HAZARDOUS WASTE ONLY)

Actual Address of Final Destination i.e. Final Recovery / Disposal Site (HAZARDOUS WASTE ONLY)

Transfer DestinationEuropean Waste

Code Hazardous Quantity T/Year Description of Waste

Waste Treatment Operation M/C/E Method Used

Location of Treatment Name and Licence / Permit No. of Recoverer / Disposer / Broker Address of Recoverer / Disposer / Broker Name and Address of Final Destination i.e. Final Recovery / Disposal Site (HAZARDOUS WASTE ONLY) Licence / Permit No. of Final Destination i.e. Final Recovery / Disposal Site (HAZARDOUS WASTE ONLY)

To Other Countries 07 05 01 Yes 343.97 aqueous washing liquids and mother liquors D10 M Volume Calculation Abroad Indaver Ireland,W0036-02

Dublin Port Waste Facility,Tolka Quay Road,Dublin Port,Dublin 1,Ireland

Indaver NV,MLAV1/9800000485,Industriele Afvalverwerking,Poldervietweg,Antwerpen 3,B-2030,Belgium

Industriele Afvalverwerking,Poldervietweg,Antwerpen 3,B-2030,Belgium

Within the Country 07 05 01 Yes 274.83 aqueous washing liquids and mother liquors D10 M Volume Calculation Onsite of generatiAstellas Ireland Co. Ltd.,P0007-03

Damastown Road,Damastown Industrial Park,Mulhuddart,Dublin 15,Ireland

Astellas Ireland Co. Ltd.,P0007-03,Damastown Road,Damastown Industrial Park,Mulhuddart,Dublin 15,Ireland


Within the Country 07 05 04 Yes 162.54other organic solvents, washing liquids and mother liquors D10 M Volume Calculation Onsite of generati

Astellas Ireland Co. Ltd.,P0007-03


Astellas Ireland Co. Ltd.,P0007-03,Damastown Road,Damastown Industrial Park,Mulhuddart,Dublin 15,Ireland


To Other Countries 07 05 10 Yes 0.046 other filter cakes and spent absorbents D10 M Weighed Abroad Indaver Ireland,W0036-02




To Other Countries 07 05 13 Yes 14.276solid wastes containing dangerous substances D10 M Weighed Abroad Indaver Ireland,W0036-02


AVG,IB 2231 - 191/04,AVG Abfall-Verwertungs-Gesellschaft mbH,Boristrasse 2,Hamburg,22113,Germany

AVG Abfall-Verwertungs-Gesellschaft mbH,Boristrasse 2,Hamburg,22113,Germany

Within the Country 07 05 13 Yes 6.86solid wastes containing dangerous substances R1 M Weighed Offsite in Ireland Indaver Ireland,W0167-03

Carranstown,Duleek,Co. Meath,A92 EP23,Ireland

Indaver Ireland,W0167-03,Carranstown,Duleek,Co. Meath,A92 EP23,Ireland


Within the Country 15 01 01 No 2.8 paper and cardboard packaging R3 M Weighed Offsite in IrelandStarrus Eco Holdings,WO188-01

Site 14B Phase 3 Road 3A,Greenogue Industrial Estate,Rathcoole,Co Dublin,Ireland

Within the Country 15 01 02 No 0.198 plastic packaging R5 M Weighed Offsite in IrelandRehab Recycle,WFP-DC-11-0025-02

The Rehab Building,Kylemore Road,Ballyfermot,Dublin 10,Ireland

Within the Country 06 01 06 Yes 5.3 other acids D9 M Weighed Offsite in IrelandRilta Environmental Ltd,W0192-03

Block 402,Greenogue Buisness Park,Rathcoole,Co. Dublin,Ireland

Rilta Environmental Ltd,W0192-03,Block 402,Greenogue Buisness Park,Rathcoole,Co. Dublin,Ireland


Within the Country 06 02 05 Yes 4.42 other bases D9 M Weighed Offsite in IrelandRilta Environmental Ltd,W0192-03




Within the Country 15 01 10 Yes 1.117packaging containing residues of or contaminated by dangerous substances R3 C Volume Calculation Offsite in Ireland

Rilta Environmental Ltd,W0192-03




Method Used

To Other Countries 15 01 10 Yes 0.519packaging containing residues of or contaminated by dangerous substances D10 M Weighed Abroad Indaver Ireland,W0036-02

Dublin Port Waste Facility,Tolka Key Road,Dublin Port,Dublin 1,Ireland



Within the Country 15 01 10 Yes 2.606packaging containing residues of or contaminated by dangerous substances R4 C Volume Calculation Offsite in Ireland

Rilta Environmental Ltd,W0192-03




To Other Countries 16 05 06 Yes 0.894

laboratory chemicals, consisting of or containing dangerous substances, including mixtures of laboratory chemicals D10 M Weighed Abroad Indaver Ireland,W0036-02




Within the Country 17 09 04 No 75.58

mixed construction and demolition wastes other than those mentioned in 17 09 01, 17 09 02 and 17 09 03 R5 M Weighed Offsite in Ireland

Starrus Eco Holdings,W0183-02

Millennium Buisness Park,Grange ,Ballycoolin,Dublin 11,Ireland

Within the Country 20 01 01 No 14.607 paper and cardboard R3 M Weighed Offsite in IrelandShred-it,WCP-DC-09-1222-01 WP-98102

Unit 53,Parkwest Industrial Park,.,Dublin 2,Ireland

Within the Country 20 01 02 No 1.65 glass R5 E Volume Calculation Offsite in Ireland

Rehab Glassco Limited,WFP-KE-08-0357-01

Unit 4,Oberstown Buisness Park,Curragh Road,Nass Co Kildare,Ireland

Within the Country 20 01 08 No 3.485 biodegradable kitchen and canteen waste R3 M Weighed Offsite in IrelandStarrus Eco Holdings,W0188-01

Site 14B Phase 3 Road 3A,Greenogue Industrial Estate,Rathcoole,Co Dublin,Ireland

Within the Country 20 01 21 Yes 0.217fluorescent tubes and other mercury-containing waste R4 M Weighed Offsite in Ireland

Irish Lamps Recycling,WFP-KE-14-0072-01

Woodcock Industrial Estate,Kilkenny Road,Athy,Co Kildare,Ireland

Irish Lamps Recycling,WFP-KE-14-0072-01,Woodcock Industrial Estate,Kilkenny Road,Athy,Co Kildare,Ireland

Woodcock Industrial Estate,Kilkenny Road,Athy,Co Kildare,Ireland

Within the Country 20 01 25 No 0.52 edible oil and fat R9 E Volume Calculation Offsite in Ireland Frylite ,WFP-FG-16-0004-01

ABP Meat Processing Plant,St Anne's Cloghran,Ballymun,Co. Dublin ,Ireland

Within the Country 20 01 35 Yes 4.02

discarded electrical and electronic equipment other than those mentioned in 20 01 21 and and 20 01 23 containing hazardous components R4 M Weighed Offsite in Ireland

Rehab Recycle,WFP-DS-10-0008-05

Unit 77,Broomhill Road,Tallaght,Dublin 24,Ireland

Rehab Recycle,WFP-DS-10-0008-05,Unit 77,Broomhill road,Tallaght,Dublin 24,Ireland

Unit 77,Broomhill road,Tallaght,Dublin 24,Ireland

Within the Country 20 01 38 No 5.96 wood other than that mentioned in 20 01 37 R3 M Weighed Offsite in IrelandStarrus Eco Holdings,W0183-02


To Other Countries 20 01 40 No 11.82 metals R4 M Weighed AbroadHaughey Metals Ltd,WL-LN 09 13

Darkley Road,Aughnagurgan,Keady,Co Armagh. BT60 3BX,United Kingdom

Within the Country 20 03 01 No 3.082 mixed municipal waste R3 M Weighed Offsite in IrelandStarrus Eco Holdings,W0183-02


Within the Country 07 05 01 Yes 46.45 aqueous washing liquids and mother liquors R1 C Weighed Offsite in Ireland Indaver Ireland,W0167-03Carranstown,Duleek,Co. Meath,A92 EP23,Ireland

Indaver Ireland,W0167-03,Carranstown,Duleek,Co. Meath,A92 EP23,Ireland


To Other Countries 08 01 11 Yes 0.713waste paint and varnish containing organic solvents or other dangerous substances D10 M Weighed Abroad Indaver Ireland,W0036-02




To Other Countries 07 05 04 Yes 189.39other organic solvents, washing liquids and mother liquors D10 M Weighed Abroad Indaver Ireland,W0036-02




To Other Countries 15 02 02 Yes 0.134

absorbents, filter materials (including oil filters not otherwise specified), wiping cloths, protective clothing contaminated by dangerous substances D10 M Weighed Abroad Indaver Ireland,W0036-02




To Other Countries 16 03 05 Yes 1.613organic wastes containing dangerous substances D10 M Weighed Abroad Indaver Ireland,W0036-02




Within the Country 07 02 12 No 1.7sludges from on-site effluent treatment other than those mentioned in 07 02 11 R1 M Weighed Offsite in Ireland

Starrus Eco Holdings,W0183-02


Within the Country 15 01 06 No 2.749 mixed packaging R3 M Weighed Offsite in IrelandStarrus Eco Holdings,W0183-02


Within the Country 17 02 02 No 0.72 glass R5 M Weighed Offsite in IrelandGannon Eco,WFP-WM-2014-05

Split Hill Quarry,Hazelwood,Kilbeggan,Co. Westmeath,Ireland

Within the Country 20 03 01 No 7.783 mixed municipal waste R3 M Weighed Offsite in IrelandStarrus Eco Holdings,W0183-02


Within the Country 20 03 07 No 18.35 bulky waste D1 M Weighed Offsite in IrelandStarrus Eco Holdings,W0183-02


* Select a row by double-clicking the Description of Waste then click the delete button

Link to previous years waste dataLink to previous years waste summary data & percentage changeLink to Waste Guidance

http://www.epa.ie/pubs/advice/aerprtr/wasteaerguid/Waste Guidance Final 13_12_11.pdf

annual environmental report for 2016 · environmental management programme – proposal appendix 3...

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