Pharmaceuticals Ireland · Teva Pharmaceutical Industries Ltd. is a global pharmaceutical company...

ANNUAL ENVIRONMENTAL REPORT 2008

Pharmaceuticals Ireland

TEVA PHARMACEUTICALS IRELAND UNIT 301

INDUSTRIAL ESTATE WATERFORD

IPC LICENCE REG. P0099-01

Page 2 of 54

TABLE OF CONTENTS

1. Introduction …............................................................................................................. 3 1.1 Executive Summary ………………………………………………………………………..3

1.2 Purpose ……………………………………………………………………………….. 3

2. Background …………………………………………………………………………. 4 2.1 The Company ………………………………………………………………………... 4 2.2 Economic Contribution ……………………………………………………………….. 4 2.3 Local Environmental Conditions ………………………………………………….. …... 4 2.4 Financial Allocation for Environment ……………………………………………… 4

3. Environmental Health & Safety Policy ………………………………………….. 5

4. Environmental Management Organization Chart ………………………………….. 6

5. Emissions to Sewer - (ES301-1) …………………………………………………... 7 5.1 Trend Analysis ………………………………………………………………………… 7 5.2 Monthly Average pH ……………………………………………………………….... 8 5.3 Monthly Average Temperature ………………………………………………………... 8 5.4 Average Flow Rate ………………………………………………………………… 9 5.5 Monthly Discharge Volumes ………………………………………………………... 9 5.6 Screening for Organics ……………………………………………………………….... 10 5.7 Details of Non-Conformances ………………………………………………………... 11 5.8 Phenol Trend 2005- 2008 ………………………………………………………………... 12 5.9 Summary of Non-Conformances 2006-2008 …………………………………………... 13

6. Surface Water Emissions – (SW301) …………………………………………… 14 6.1 Monthly Average pH ………………………………………………………………… 14 6.2 Monthly Average TOC ………………………………………………………………… 14 6.3 Monthly Conductivity ……………………………………………………………….... 15 6.4 Details of Non-Conformances ……………………………………………………….. 15

7. Emissions to Atmosphere: …………………….……………………………………... 16 7.1 Mass Emissions for VOC’s and Particulates 2006 - 2008 ……………………..………. 16 7.2 Air Emission Summary …………………………………………………...…………… 17

8. Hazardous & Non-Hazardous Waste Management …………………………… 18 8.1 Hazardous Waste Data Table 2008: ……………………………………………….. 18 8.2 Non-hazardous Data Table 2008: ……………………………………………….. 19 8.3 Hazardous Waste Summary 2006-2008: ……………………………………………….. 20 8.4 Non-Hazardous Waste Summary – 2006-2008: ………………………………………. 21

9. Energy & Water Consumption …………………………………………………… 22 9.1 Energy Consumption: 2006 – 2008 ……………………………………………….. 22 9.2 Water Consumption: 2006 – 2008 ……………………………………………….. 23

10. Solvent Usage & Pollutant Release and Transfer Register ………………………… 24 10.1 Summary Information: Solvent Usage 1998 – 2008……………………………………… 24 10.2 Pollutant Release and Transfer Register 2008…………………………………………….. 24

11. Noise …………………………………………………………………………………… 25 11.1 Findings of Noise Survey Report 2008……………………………………………..……… 25 11.2 Noise Survey Report ………………………………………………………………… 25

12. Environmental Complaints …………………………………………………………… 26 12.1 Complaint Details ………………………………………………………………… 26

13. Management of the Activity …………………………………………………………… 26 13.1 Teva’s Future Plans for the Management of the Activity ……………………………… 26 13.2 Environmental Management Programme ……………………………………………….. 26

APPENDIX 1 Pollution Emission Register 2008 APPENDIX 2 Noise Survey Report 2008

Page 3 of 54

1. INTRODUCTION

1.1 Executive Summary

The AER for 2008 has remained consistent with the terms of the licence and is in line with previous years.

There are however some notable exceptions. In 2009, Teva Pharmaceuticals Ireland hopes to gain

accreditation to both OHSAS 18001 and ISO 14001 from BSI (British Standards Institute). Hence, these

management systems will become the cornerstone of developing the environmental objectives and targets

(ISO 14001). This report integrates the objectives and targets from this management system with the current

objectives and targets from 2007. The previous objectives and targets are complete or as already mentioned

have been amalgamated with ISO 14001.

The majority of metrics show that Teva is in line with its IPPC licence and has applied BAT and

improvement systems to its plant.

Furthermore, the company expects to have certain areas of its IPPC licence revisited by the EPA in 2009.

The licence is a number of years old, and hence certain conditions contained within it may no longer be be

relevant to current site activities.

The AER/PRTR returns template that the EPA sent out still has Ivax Pharmaceuticals Ireland as the name of

the company. This will be adjusted for next year.

1.2 Purpose

This Annual Environmental Report is submitted in fulfilment of condition 2.9.2 of the IPC Licence (Licence

Register No.P0099-01) issued on the 30th May 1997.

This format, by authority of the agency, presents summary information (in line with the Guidance notes for

the Annual Environmental reporting), for the year 2008.

Also in this AER is a draft environmental management programme for 2008 onwards that will replace the

previous programme that covered the period 2003 – 2007.

Page 4 of 54

2. BACKGROUND

2.1 The Company

Teva Pharmaceutical Industries Ltd. is a global pharmaceutical company specializing in the development,

production and marketing of generic and proprietary branded pharmaceuticals as well as active

pharmaceutical ingredients.

Teva Pharmaceuticals Ireland consists of Aerosol manufacturing plants producing asthmatic inhalers and an

Oral Solid Dose manufacturing and packaging plant producing generic prescription tablets/capsules.

Extensive quality control and assurance departments support the manufacturing operations. TEVA also have

extensive R&D Departments, responsible for the design, development and introduction of their product

range.

The aerosol plants (units 14-15 and 27-35), are not IPC licensable activities. The tablet manufacturing and

packaging plant (unit 301) is licensed under section 12.2.2 of the first schedule of the EPA Act 1992.

The company has operated an Environmental Management System since 1994 when a preliminary

environmental review was performed. Teva maintains a full time EHS department, consisting of an EHS

Manager, an EHS Officer, an H&S Specialist, an Occupational Health Nurse and a Process Safety Specialist.

2.2 Economic Contribution

The company currently employs a total of 828 personnel in Waterford of which approximately 491

employees are involved in the Unit 301 Solid Dose plant operation.

2.3 Local Environmental Conditions

The location of Teva Pharmaceuticals Ireland on the IDA Industrial Park, Waterford, could be described as

suburban, bordering on rural. The site is approximately 2 kilometres from the city. The surrounding land is

mainly used for agriculture particularly to the North and North West of the estate, however due to economic

growth in the region the rural surroundings are becoming more developed with commercial and industrial

units under construction. The nearest features of interest within a 5 km. radius are St. Otteran’s cemetery, the

River Suir, and the dispersed prehistoric and early Christian monuments in the surrounding area.

2.4 Financial Allocation for Environment The major capital items to support the IPC programme have already been committed. Environmental, health

and safety is a discrete cost centre in its own right within Teva

Page 5 of 54

3. ENVIRONMENTAL HEALTH AND SAFETY POLICY

Page 6 of 54

4. Environmental Management Organisation Chart

TEVA Ireland’s General Manager

Inhalations Plant manager

Head of Materials

Head of Quality

Solid Dose Plant Manager

Head of Finance

Head of Human Resources

Director of R&D Waterford

EHS Manager

Occupational Health Nurse

Process Safety Specialist

EHS Officer

H&S Specialist

Head of Human Resources

EHS Manager

Occupational Health Nurse

Process Safety Specialist

EHS Officer

H&S Specialist

Page 7 of 54

5. Emissions to Sewer - (ES301-1)

5.1 Emissions to Sewer - Trend Analysis and Summary Data of Mass Emissions

Mass Emissions - Trend Analysis (a)

0

2000

4000

6000

8000

10000

12000

14000

16000

18000

20000

Parameter

Mass Emission (kgs)

2006 4088 166 156 1488 371 153

2007 3315 196 95 1204 280 95

2008 4913 306 309 1558 499 131

Limit 18250 18250 18250 9125 3650 1825

COD Chlorides Sulphates BOD Suspended Solids Oils/Fats/Greases

Mass Emissions - Trend Analysis (b)

0.00

20.00

40.00

60.00

80.00

100.00

120.00

140.00

160.00

180.00

200.00

Parameter

Mass Emission (kgs)

2006 0.96 37.25 0.14 17.80 1.78

2007 1.10 34.97 0.00 2.63 0.93

2008 52.90 68.28 6.75 14.98 1.49

Limit 182.5 91.25 91.25 36.5 1.825

Nitrates Phosphorus Heavy Metals Ammonia Phenols

Page 8 of 54

5.2 Monthly Average pH:

Emissions to Sewer - Average pH

4.00

5.00

6.00

7.00

8.00

9.00

10.00

Month

pH Scale

2006 6.94 7.01 7.01 6.95 6.86 7.21 7.46 7.32 7.16 7.37 7.18 6.74

2007 7.40 6.42 6.98 6.70 6.84 6.94 6.81 6.87 7.01 7.24 6.93 6.71

2008 6.85 6.70 7.04 6.83 6.82 6.68 7.30 6.63 7.04 7.53 7.12 7.15

L Limit 6 6 6 6 6 6 6 6 6 6 6 6

U Limit 9 9 9 9 9 9 9 9 9 9 9 9

1 2 3 4 5 6 7 8 9 10 11 12

UPPER LIMIT

LOWER LIMIT

5.3 Average Monthly Temperature:

Emissions to Sewer - Average Temperature

0

5

10

15

20

25

30

35

40

45

Month

Temperature (oC)

2006 9.9 10 11.25 14.4 16.7 19.8 20.2 17.7 17.97 15.5 11.54 8.8

2007 9.13 8.98 9.7 12.05 14.03 16.78 16.16 15.74 15.29 13.75 10.74 9.2

2008 9.02 8.76 8.71 10.25 13.68 15.63 17.43 16.48 15.99 14.08 11.18 9.42

Limit 42 42 42 42 42 42 42 42 42 42 42 42

1 2 3 4 5 6 7 8 9 10 11 12

EMISSION LIMIT

Page 9 of 54

5.4 Average Monthly Flow Rate:

Emissions to Sewer - Average Flowrate

0

1

2

3

4

5

6

7

8

m3/h

2006 0.541 1.23 1.09 0.74 0.53 0.83 0.74 1.07 0.75 0.79 0.78 0.79

2007 0.6135 1.0367 0.8418 1.1663 2.1664 1.3679 0.79 1.1881 1.3167 0.7336 0.8555 0.6583

2008 0.96 0.76 0.95 0.82 0.81 0.99 0.92 0.9 1.03 1.21 0.98 1.1

m3/hr 7 7 7 7 7 7 7 7 7 7 7 7

Jan Feb Mar Apr May June July Aug Sept Oct Nov Dec

5.5 Monthly Discharge Volumes:

Emissions to Sewer - Discharge Volumes

0

100

200

300

400

500

600

700

800

900

1000

Month

Discharge Volumes (m

3)

Discharge Volumes 2006 393.26 820.33 628.85 521.73 386.44 586.91 527.23 781.12 533.28 541.76 551.11 576.01

Discharge Volumes 2007 447 449 530 248 98 231 569 566 549 514 604 454

Discharge Volumes 2008 682 543 658 516 578 700 649 655 784 909 692 773

Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec

MEMISSION LIMIT

Page 10 of 54

5.5 Screening for Organics

TEVA analyses the effluent from ES301-1 for the most commonly used solvents, namely Methylene

Chloride, Methanol, Acetonitrile, Chloroform and Isopropanol.

5.6.1 Summary Information of Screening for Organics 2008



Date Methylene

Chloride Methanol Isopropanol Acetonitrile Chlorofor

m

17/04/08 <1.0 ppm 11.2 ppm <1.0 ppm <1.0 ppm <1.0 ppm

11/06/08 <1.0 ppm 8.55 ppm <1.0 ppm <1.0 ppm <1.0 ppm

19/11/08 <1.0 ppm <1.0 ppm <1.0 ppm 2.4 ppm <1.0 ppm

17/12/08 <1.0 ppm <1.0 ppm <1.0 ppm <1.0 ppm <1.0 ppm

Date Methylene

Chloride Methanol Isopropanol Acetonitrile Chlorofor

m




19/12/07 <0.1 ppm 10.9 ppm 2 ppm <0.1 ppm <0.1 ppm

Date Methylene

Chloride Methanol Isopropanol Acetonitrile Chloroform

23/03/’06 <0.1 ppm <0.1 ppm <0.1 ppm <0.1 ppm <0.1 ppm




Page 11 of 54

5.7 Details of Non-Conformances – Effluent 2008

Date Non-Compliance Cause Corrective Action

July

August

Suspended Solids

concentration exceeded

emission limit value.

Adverse weather

conditions caused the sump

in treatment plant bund to

fill with rain water which

agitated sludge on the base

of the sump. When the

level of water in the sump

reached the “high” level

the contents were

automatically pumped

through the system causing

elevated suspended solids

concentrations in the waste

water.

Horizon Environmental

called to site (08/09/’08)

to pump out sludge from

the sump and any other

areas where sludge may

have settled in the

system. The frequency of

sludge removal will be

increased to ensure the

same conditions will not

occur in the future

December Ammonia concentration in

the effluent exceeds the

licence ELV following

monthly analysis.

The exceedence in

Ammonia may be as a

result of the use of a

chemical that is used in the

boilers. This chemical,

Alchem 1102 is used in

preventative maintenance

of the boilers and was used

around the date that

TelLabs took the sample

(17th December 2008- 20

th

December 2008). This is

we feel the cause of the

high ammonia reading.

Discussion with

engineering concerning

Alchem 1102 to highlight

the issue of an amine

group attached to the

chemical and

consequently its relation

to the IPPC licence.

April

May

June

July

August

October

November

Phenol concentration in the

effluent exceeds the

licence ELV following

monthly analysis.

Investigation into the level

of phenol in the waste

water has shown that raw

materials used in the

company are phenolic in

origin themselves.

It can be seen from the

phenol trend graph ’05-

’08, 5.8 below, that there

has been a significant

reduction in phenol

emitted over this period.

December Total Phosphorus

The total Phosphorus

investigation has proven to

be inconclusive. Prior to

the Christmas period, there

was a large scale clean

down. This would have

meant that some of the

cleaning agents used may

have had phosphorus or a

derivative of it. It is only

presumption to suggest that

perhaps there was over

zealous amount of cleaning

agent used.

Further discussion

surrounding Phosphorus

to continue within the

company to understand

better where this

exceedence originated

Page 12 of 54

5.8 Phenol Trend 2005- 2008

Phenol Trend 2005 - 2008

0

0.5

1

1.5

2

2.5

Jan '05Mar

May

July

SeptNov

Jan '06

Mar

May

July

SeptNov

Jan '07

Mar

May

July

SeptNov

Jan '08Mar

May

July

SeptNov

Phenol (mg/l)

Phenol Limit Linear (Phenol)

Page 13 of 54

5.9 Summary of Non-Conformances Summary 2006-2008

Summary of Non - Conformances Summary 2006-2008

0

5

10

15

20

25

Emmision

No. of Non-Conformances

2006

2007

2008

2006 4 11 0 0 0 1 0 0 16

2007 0 8 0 2 0 1 0 0 11

2008 0 18 0 0 0 1 2 1 22

Discharge

volumePhenol pH COD BOD Ammonia

Suspended

solidsPhosphorus Total

Summary of improvements in control:

• The number of “discharge volume” non-conformances has decreased significantly due to;

o Increased control on the diversion system on the outflow. This had been identified

previously as an issue that needed to be rectified.

o Increased control in the manufacturing wash down cycle that prevented previous

incidents where excessive amounts of wash water generated led planned releases, above

the licensed limit, in order to prevent the waste water treatment plant overflowing.

• Modifications to the diversion control system also led to the elimination of non-conformances

whereby waste water could be released to the environment when out of specification.

• Phenol emission rates have flattened out from the early reductions in January 2005 to the

present levels which have become the norm. Waterford County Council have agreed to an

emission limit increase on the trade effluent licence from 0.1 mg/l to 0.5 mg/l which will

eliminate the major issue with phenol, subject to approval by the Agency.

Page 14 of 54

6. Surface Water Emissions – (SW301)

6.1 Surface Water – Average Monthly pH:

Surface Water - Average pH

4

5

6

7

8

9

10

Month

pH Scale

2006 7.774 7.859 7.459 7.414 7.707 7.825 7.358 7.72 7.31 7.717 7.77 7.88

2007 7.821 7.587 7.674 7.074 7.292 7.51 7.488 7.699 7.741 7.548 7.266 7.575

2008 7.792 7.408 7.778 7.129 7.704 7.979 7.552 7.345 7.783 8 7.87 7.731

Lower Limit 6 6 6 6 6 6 6 6 6 6 6 6

Upper Limit 9 9 9 9 9 9 9 9 9 9 9 9


6.2 Surface Water - Monthly Average Total Organic Carbon:

Surface Water - Total Organic Carbon

0

10

20

30

40

50

60

70

Month

TOC (PPM)

2006 3.2 2.06 4.43 2.45 4.67 4.9 4.22 6.52 6.23 5.48 4.21 3.97

2007 5.76 5.16 4.66 5.21 9.09 5.24 6.76 2.63 5.86 5.1 5.6 5.6

2008 9.72 9.88 9.2 10.21 9.33 12.39 10.52 8.71 4.53 9.34 10.18 21.38

Emission Limit 60 60 60 60 60 60 60 60 60 60 60 60

1 2 3 4 5 6 7 8 9 10 11 12

Page 15 of 54

6.3 Surface Water - Monthly Conductivity:

Surface Water - Conductivity

0

0.1

0.2

0.3

0.4

0.5

0.6

Month

Conductivity (ms)

2006 0.425 0.443 0.497 0.395 0.158 0.259 0.284 0.352 0.448 0.464 0.482 0.457

2007 0.401 0.489 0.399 0.422 0.418 0.477 0.484 0.491 0.389 0.389 0.357 0.329

2008 0.399 0.412 0.443 0.45 0.42 0.406 0.432 0.405 0.435 0.467 0.493 0.457


6.4 Summary of Surface Water Non-Compliances, SW301

Date Non-Compliance Cause Corrective Action

N/A N/A N/A N/A

There was no surface water non-compliances recorded during 2008.

Page 16 of 54

7 Emissions to Atmosphere: 2006 - 2008

7.1 Mass Emissions for VOC’s and Particulates 2005 - 2007

Note: Below graphs also shows 2005 emissions for both Methylene Chloride and Isopropanol but is not

shown above in the three year table

7.1.1 Methylene Chloride ’05-’07.

Methylene Chloride

0

0.005

0.01

0.015

0.02

0.025

0.03

0.035

0.04

0.045

0.05

kgs

Methylene Chloride 0.017 0.047 0.035

2005 2006 2007

7.1.2 Isopropanol ’05-’07.

Isopropanol

0

0.0005

0.001

0.0015

0.002

0.0025

0.003

kgs

Isopropanol 0.0025 0.0016 0.0005

2005 2006 2007

Emission

Point

Process Parameter 2006 - Mass

Emissions (Kg)

2007 - Mass

Emissions (Kg)

2008 - Mass

Emissions (Kg)

301/1.16 TU6 Methylene Chloride .047 kg .035 kg N/A

301/1.16 TU6 Isopropanol .0016 kg .0005 kg N/A

301/1.16 TU6 Ethanol N/A N/A 0.117 kg

301/2.3 ANDA Particulates .0000014 kg .0000006 kg N//A

Page 17 of 54

7.1.3 Ethanol ’06 –‘08

Ethanol

0

0.02

0.04

0.06

0.08

0.1

0.12

0.14

Kg

s

Ethanol 0 0 0.117

2006 2007 2008

7.1 Air Emissions Summary:

• The above data shows information from the 2007 AER as well as information collected

during 2008 for one solvent, ethanol.

• During an inspection by Tony Dolan and Pamela McDonnell of the Environmental

Protection Agency, the difficulty in sampling of the solvents used at Teva Pharmaceuticals

Ireland was discussed.

• In 2008, Ethanol was the only solvent sampled for at emission point 301/1.16. This was due

to a variety of reasons, including the fact that emission points were not in use during the

year and difficulties in arranging the sampling of batch processes.

• As a result of this conversation with the before mentioned EPA inspectors, the company

hopes to apply to the EPA to discontinue the monitoring of air emissions as it feels they no

longer represent a licensable activity in 2009.

8 Hazardous & Non-Hazardous Waste Management

8.1 Hazardous Waste Data Table 2008:

European Waste

Catalogue Code

Hazardous

(Yes/No)

Description of

Waste

Quantity

(t/year)

Disposal/ Recovery

Code

Location of

Disposal/

Recovery

Name of Waste

Disposal Recovery

Contractor

Licence /

Permit

Reference

07 05 03* Yes Chlorinated Solvent 7.093

D10 Incineration on

land

(c) Off-site

Abroad

DEE Environmental

Services c/o Veolia AG8233

07 05 04* Yes

Non Chlorinated

Solvent 44.72

D10 Incineration on

land

(c) Off-site

Abroad

DEE Environmental

Sevices c/o Veolia AG8233

07 05 99 Yes

Tablet/Powder/Filter

waste 120.53

D10 Incineration on

land

(c) Off-site

Abroad

DEE Environmental

Services c/o SAVA A 51G00508

16 05 07* Yes

Residual Laboratory

Waste 0.249

D10 Incineration on

land

(c) Off-site

Abroad

DEE Environmental


16 05 08* Yes

Residual Laboratory

Waste 0.778

D10 Incineration on

land

(c) Off-site

Abroad

DEE Environmental


15 01 10 Yes Drums 1.582

D9 Physico Chemical

Treatment

Off Site, Eire

DEE

Environmental

Services c/o AVR

Safeway, Corrin,

Fermoy

50-1

15 02 02* Yes Filters 5.644

D10 Incineration on

land

(c) Off-site

Abroad

DEE Environmental


18 01 03 Yes Clinical Waste 1.4448

D9 Physico Chemical

Treatment

Off Site, Eire

DEE

Environmental

Services C/o

Ecosafe Systems

54-2

Page 19 of 54

8.2 Non- Hazardous Waste Data Table 2008:

European Waste

Catalogue Code

Hazardous

(Yes/No)

Description of

Waste

Quantity

(t/year)

Disposal/ Recovery

Code

Location of

Disposal/

Recovery

Name of Waste

Disposal Recovery

Contractor

Licence /

Permit

Reference

20 03 01 No

General /

Canteen Waste 274.56

D1 Deposit on, in or

under land.

(b) Off-site

Ireland

Baleally Landfill,

Lusk, Co. Dublin. -

KTK Landfill Ltd.,

Kilkullen, Co.

Kildare.

WL Ref: 9-2

& WL Ref:

81-2

15 01 01 No Cardboard

284.89

R5

Recycling/reclamation of

other inorganic materials

(b) Off-site

Ireland Smurfit Recycling WP021

15 01 02 No Plastic (Bales) 106.49

R5



(c) Off-site

Abroad Dilloan Recycling BLT658585

20 01 08 No Compost 16.03

R10 Land treatment

resulting in benefit to

agriculture or ecological

improvement

(b) Off-site

Ireland

Veolia

Environmental

Services. WR/02/00

20 01 01 No

Confidential

Paper

101.46

R5



(b) Off-site

Ireland Smurfit Recycling WP021

15 01 03 No Timber Pallets 29.32

R7 Recovery of

components used for

pollution abatement

(b) Off-site

Ireland

Veolia

Environmental

Services. WR/02/00

15 01 07 No Glass 10.56

R5



(b) Off-site

Ireland

SFL Calan, Co.

Kilkenny WR/02/00

20 01 40 No Scrap Metal 30.54

R5



(b) Off-site

Ireland

Midland Scrap

Metal Recycling WMB005

8.3 Hazardous Waste Summary 2006-2008:

Hazardous Waste Summary 2006-2008

0

50

100

150

200

250

Tonnes

2006 160.28 28.1 2.94 1.2 1.208 0 9 0 0 0 202.728

2007 143.18 20.42 18.81 0.61 3.981 0.028 0 0.11 1.598 1.5522 190.2892

2008 120.53 44.72 7.093 1.027 5.644 0 0 0 1.582 1.4448 182.0408

Tablet &

Powder

Non-

Chlorinated

Solvent

Chlorinated

Solvent

Residual Lab.

ChemicalsFilters Glass

Waste

Washings

Fluorescent

TubesDrums Clinical waste TOTALS

The graph below normalizes the amount of hazardous waste generated per unit of production ‘06-

08’

Hazardous Waste / Unit Produced

0

10

20

30

40

50

60

70

80

mg/unit

Haz Waste per Unit 67.5 67.9 48.9

2006 2007 2008

Page 21 of 54

8.4 Non-Hazardous Waste Summary – 2006-2008:

Non-hazardous Waste Summary 2006 - 2008

0

100

200

300

400

500

600

700

800

900

Tonnes

Landfilled 183.84 197.3 274.56

Recycled 248.05 306.88 579.29

Total 431.89 504.18 853.85

2006 2007 2008

The graph below normalizes the amount of non-hazardous waste generated per unit of production

’06-‘08.

Non Hazardous Waste / Unit Produced

0

50

100

150

200

250

mg/unit

Non Haz Waste per Unit 144 180.06 229.5

2006 2007 2008

Page 22 of 54

9. Energy and Water Consumption.

9.1 Energy Consumption: 2006-2008

Energy Consumption - Gas/Electricity

0

2000

4000

6000

8000

10000

12000

14000

16000

18000

20000

Year

Energy (MWhr)

Gas MWhr 5699 6683 8248

ElectricityMWhr 9118 9517 9894

Total MWhr 14817 16200 18142

2006 2007 2008

The graph below normalizes the amount of energy consumed per unit of production ’06-‘08.

Energy Consumed / Unit Produced

0

1

2

3

4

5

6

7

Watt Hrs

Total Whr/unit 3.69 5.78 4.9

2006 2007 2008

Page 23 of 54

9.2 Water Consumption: 2006-2008

Water Consumption 2006-2008

0

2000

4000

6000

8000

10000

12000

14000

16000

Cubic Meters

Consumption m3 12780 8886 13892

2006 2007 2008

The graph below normalizes the amount of water consumed per unit of production ’05-‘07.

Water Consumption / Unit Produced

0

0.5

1

1.5

2

2.5

3

3.5

4

4.5

5

Cubic Meters

Consumption m3 4.3 2.8 3.7

2006 2007 2008

Page 24 of 54

10. Solvent Usage & Pollutant Release and Transfer Register

10.1 Summary Information: Solvent Usage 1998 - 2008

0

2,000

4,000

6,000

8,000

10,000

12,000

14,000

Usage (Tonnes)

Solvent Usage - Solid Dose Manufacture

Methylene Chloride 2,818 1,141 1,983 969.98 1038.31 802.56 1557.84 1010.92 919.44 734.15 1,003.20

Isopropanol 7,455 11,805 10,900 5853.45 4407.83 4092.77 4185.45 1882.329 1294 258.11 243.65

Methanol 876 122 0 0 0 0 0 0 0 0 0

Ethanol 0 0 0 0 0 0 0 0 0 0 2172.49

Total 11,149 13,068 12,833 6823.43 5446.14 4895.33 5743.29 2893.249 2213.44 992.26 3,419.34

1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008

Teva Pharmaceuticals Ireland expects the solvent usage for 2009 to be considerably higher than

2008.

10.2 Pollutant Release and Transfer Register

The pollution releases and transfers set out in statutory instrument S.I. No. 123 of 2007, European

Communities (European Pollutant Release and Transfer Register) Regulations 2007 is reported

differently since 2007.

The PRTR information is now reported electronically via the AER Electronic Reporting interface

set up on the Environmental Protection Agency’s website. Appendix I is a summary of the PRTR

requirements as they relate to Teva Pharmaceuticals Ireland

11. Noise

A night-time and day-time noise monitoring survey was carried out in 2008 as per condition 8

(Noise) of the IPC Licence. Noise monitoring was undertaken at two site boundary locations (N1 &

N2) and two noise sensitive boundaries (NS1 & NS2) in the vicinity of the site.

11.1 Findings of Noise Survey Report

There are no major noise contributors for the Teva Pharmaceuticals Ireland site. The nearest noise

sensitive locations are a private residence and a residential estate near Teva Pharmaceuticals, which

lies beyond other factories operating within the industrial estate and would therefore be influenced

by many other sources.

Only one result was found to exceed the limit by more than 2dB(A), i.e. the night-time reading at

NS2. However, the main source of noise during the monitoring was the morning traffic on the

nearby roads (the survey was carried out from 6am). It is therefore the opinion of this report that the

company did not constitute a noise nuisance.

All the other readings were found to be compliant.

11.2 Noise Survey Report

See Appendix II for full noise survey report.

12 Environmental Complaints

There were no environmental complaints reported in 2008.

13. Management of the Activity.

13.1 ENVIRONMENT AND SAFETY OBJECTIVE # SHE 1:

Implement OHSAS 18001 and ISO 14001

REASON

To improve SHE performance and ensure that an ongoing continuous improvement philosophy is

translated into results

Reference: ISO 14001: 2004/OHSAS 18001:2007

PROJECT METHOD

STEP METHOD

1 Undertake Initial Status Review/Initial

Environmental Review

2 Draft EH&S Policy

3 Draft Register of Aspects

4 Review Risk Assessments

5 Draft, review and agree EH&S

Management Plan

6 Draft management systems manual

7 Identify certification body

8 Training and awareness for employees

9 Internal EHS audit programme

10 Management Review process

11 Conduct Pre-Assessment audit

12 Schedule certification audit

13.2 ENVIRONMENTAL OBJECTIVE # SHE 2

Page 27 of 54

Minimise the potential impact of hazardous materials on health and safety and on the environment.

REASON

Hazardous materials are highly regulated and are inherently hazardous to the environment and

health and safety.

Reg. of Aspects Reference: # 1 Hazardous Materials

Health and Safety Hazards: Ref. Chemical Risk Assessments, Task based assessments, ATEX risk

assessments, HAZOPs

Examples of Applicable Legislation:

� EC (Classification, Packaging, Labelling and Notification of Dangerous Substances)

Regulations 2003 and the European Communities (Classification, Packaging, Labelling and

Notification of Dangerous Substances) (Amendment) Regulations 2006, 2008

� REACH Regulation 1907/2006/EC

� Chemicals Act 2008

� Safety, Health and Welfare at Work (Chemical Agents) Regulations 2001

� 2007 Code of Practice for the Safety, Health and Welfare at Work (Chemical Agents)

Regulations 2001

PROJECT METHOD

STEP METHOD

1 Eliminate CFC use from site and replace with

HFA and ethanol

2 Decommission P12 Storage Tanks

3 Remove residual CFC (P11) from storage on

site

4 Minimise laboratory hazardous materials and

waste by implementing project plans (as

developed with PM)

5 Design, develop, construct and operate single

chemical store for TEVA with chemical and

API storage.

6 Upgrade existing chemical and API handling

� Install new containment equipment

� Ensure compliance with the TEVA

Corporate “Guidelines for Safe

Handling of APIs and Drugs”

(NWM66)

� Install and commission new

dispensing system with improved

containment

� Install and commission upgraded

central dust collection system

7 Dangerous Goods Safety Advisor audits and

action plans to be implemented

8 New hazardous materials management

procedure to be formalised in the system

9 Dangerous Goods software sourced and

implemented

10 Audit licensed dangerous materials hauliers

and ensure compliance

Page 28 of 54

13.3 ENVIRONMENTAL AND SAFETY OBJECTIVE # SHE 3

Minimise the impact of waste water emissions and eliminate the causes of non-compliances against

the waste water ELVs.

REASON To ensure that TEVA Pharmaceuticals reduces its overall environmental impact by addressing its most

significant environmental aspects Teva will ensure it is compliant with its IPPC License conditions and

minimises the impact of its waste water emissions.

Reg. of Aspects Reference: # 2 Waste water emissions

Legal and other requirements: IPPC License Reg. No. P0099-1

PROJECT METHOD

STEP METHOD 1 Investigate cause of phenol exceedences 2 Investigate the cause of COD exceedances

during 2007 3 Investigate the cause of ammonia

concentration exceedance 4 Review phenol license limit with the

Environmental Protection Agency based

on:

� Significant improvements over recent

years

� Probable link to API chemical

characteristics

� Existing ELV is an order of magnitude

below the ELV for comparable

pharmaceutical companies

� Cost of implementing further

reductions as against potential benefits

and possible alternative use of capital 5 Investigate equipment upgrade and/or

treatment options at the WWTP. Identify

project options and capital costs.

Page 29 of 54


Reduce the impact of hazardous and non-hazardous waste on the environment and on employee

health and safety.

REASON

Hazardous waste and non-hazardous waste have been identified as the environmental aspects with

the 3rd and 4th most significant impacts on the environment, and constitute a very significant cost

to the company. In addition, hazardous waste retains the hazardous characteristics of the hazardous

materials which it contains.

Reference:

In addition to the legislation referenced under objective 2, the following selected waste

management legislation applies:

• National Recycling Strategy

• Waste Management (Amendment of Waste Management Act 1996) Regulations 1998 Waste

Management (Haz. Waste) Regulations 1998 and Waste Mgt (Haz. Waste) (Amendment)

Regulations 2000

• Waste Management (Movement of Hazardous Waste) Regulations 1998

• Waste Management (Shipments of Waste) Regulations 2007

• Waste Management (Waste Electric and Electronic Equipment) Regulations 2005 and

(Amendment) Regulations 2008

• Waste Management (Packaging) Regulations 2007

• Waste Management (Landfill Levy) Regulations 2008

PROJECT METHOD

STEP METHOD 1 Each department to set up waste reduction

and management teams 2 Each department to implement systems to

monitor waste generation and implement

reduction projects 3 Each department to supply monitoring

data to the EH&S department

Page 30 of 54


Implement the energy management system IS 393.

REASON

Minimise the impact and cost of energy use at Teva Pharmaceuticals Ireland. Energy use has been

identified as the fifth most significant environmental impact at Teva Pharmaceuticals Ireland.

Reference:

IS 393

Register of Environmental Impacts

IVAX Pharmaceuticals (TEVA) AER 2007.

PROJECT METHOD

STEP METHOD 1 Obtain senior site management

commitment for certification to IS 393. 2 Agree project sponsor, project leader and

project team. 3 Draft Review of Energy Aspects 4 Prepare Register of Energy Legislation 5 Finalise Management Programme /

Develop corporate Objectives and

Targets. 6 Prepare Energy Management Systems

Manual 7 Identify certification body 8 Decide on target certification date

Page 31 of 54

Appendix I

Summary PRTR/AER Returns 2008

.3 RELEASES TO WASTEWATER OR SEWER

6 6

POLLUTANT

No. Annex II Name M/C/E

Method Code QUANTITY

71 Phenols (as total C) M PER

35 Dichloromethane (DCM) M PER T (Total) KG/Year A (Accidental) KG/Year

F (Fugitive) KG/Year

23 Lead and compounds (as Pb) M PER 1.825 1.825 0.0

13 Total phosphorus M PER 0.0 0.0 0.0

79 Chlorides (as Cl) M PER 0.0 0.0 0.0

68.28 68.28 0.0

306.0 306.0 0.0

POLLUTANT

Pollutant No. Name M/C/E

Method Code

238 Ammonia (as N) M PER QUANTITY

303 BOD M PER

306 COD M PER T (Total) KG/Year A (Accidental) KG/Year

F (Fugitive) KG/Year

314 Fats, Oils and Greases M PER 14.98 14.98 0.0

327 Nitrate (as N) M PER 1558.0 1558.0 0.0

343 Sulphate M PER 4913.0 4913.0 0.0

240 Suspended Solids M PER 131.0 131.0 0.0

52.9 52.9 0.0

309.0 309.0 0.0

499.0 499.0 0.0

Page 33 of 54

5. ONSITE TREATMENT & OFFSITE TRANSFERS OF WASTE

Transfer Destination

European Waste Code Hazardous

Quantity T/Year Description of Waste

Waste Treatment Operation

Address of Recoverer / Disposer / Broker

Name and Address of Final Destination i.e. Final Recovery /

Disposal Site (HAZARDOUS WASTE ONLY)

Within the Country 20 03 01 No 274.56 General/Canteen Waste D1

Six Cross Roads Business Park, Lacken Road, Waterford

Within the Country 15 01 01 No 284.89 Cardboard R5


Within the Country 15 01 02 No 106.49 Plastic (Bales) R5


Within the Country 20 01 08 No 16.03 Compost R10


Within the Country 20 01 01 No 101.46 Confidential Paper R5


Within the Country 15 01 03 No 29.32 Timber Pallets R7


Within the Country 15 01 07 No 10.56 Glass R5


Within the Country 20 01 40 No 30.54 Scrap Metal R5


To Other Countries 07 05 03 Yes 7.093 Chlorinated Solvents D10

Barretts Lane, Ardea, Co.Louth

Veolia, Bridges Road, Elesmere Port, Chesire, Uk

To Other Countries 07 05 04 Yes 44.72 Non Chlorinated Solvnets D10


Veolia, Bridges Road, Elesmere Port, Chesire, Uk

Page 34 of 54

To Other Countries 07 05 99 No 120.53

Table/Powder/Filter Waste D10


SAVA GmbH & Co., Ostertweute 1, Brunsbuttel, D25541, Germany

To Other Countries 16 05 08 Yes 0.778

Residual Laboratory Waste D10



Within the Country 15 01 10 Yes 1.582 Drums D9


AVR Safeway, Corrin, Fermoy, Co. Cork

To Other Countries 15 02 02 Yes 5.644 Filters D10



Within the Country 18 01 03 Yes 1.4448 Clinical Waste D9


EcoSafe Systems, Unit 1A, Allied Industrial Park, Kylemore Road, Dublin 10.

To Other Countries 16 05 07 Yes 0.249

Residual Laboratory Waste D10



Page 35 of 54

Appendix II

Noise Survey Report 2008

Tel: 353 1 276 1428 Fax: 353 1 276 1561 Email: [email protected]

www.enviro-consult.com

Registered Office as above. Registered Number 243 412

Environmental Noise Survey

For

Ivax Pharmaceuticals

Document Number: 853-03

Ivax Pharmaceuticals Environmental Noise Survey

Environmental Efficiency Page 38 of 54

Document No. 853-03 v1.00

QF 1. v2 Document Lead Sheet

Document Title Environmental Noise Survey

Project No. 853

Document No. 853-03

Client Ivax Pharmaceuticals

Address Unit 301, IDA Industrial Estate, Waterford, Co Waterford

Signed for and on behalf of Issue Status Date Author

Environmental Efficiency Client

1.00 Approved 18/12/2008 SR

Where it is a requirement that this report be issued to a regulatory or other authority, then the client should sign the

appropriate place in the above table and, unless specifically agreed in writing to the contrary, forward copies to the

appropriate authority (e.g. EPA).

EEC Project Manager: Bob Sutcliffe, CEng, MIMechE

EEC Document Author: Stephen Ryan, BA, MSC Env.

Conditions relating to the issue of this report:

1. No alteration to this report by third parties is permitted

2. Where this report is reproduced, it shall only be reproduced in full.

3. Reports remain the property of Environmental & Efficiency Consultants (Ireland) Limited until paid for in

full.




Summary of results

Office of Environmental Enforcement

PO Box 3000

Johnstown Castle Estate

Co Wexford

IPC Licence Number: 99

Company Name: Ivax Pharmaceuticals

Reporting Period: 2007

Report Name: Environmental Noise Survey

Were all results compliant with the terms of the IPPC licence? Yes No

√

Note 1: It should be noted that morning traffic on nearby roads was the main source

of noise and that it is the opinion of this report that the company did not constitute a

noise nuisance

Were any complaints received during this reporting period?

Yes No

√

Date 10/12/2008

Parameter Night-time Leq, t

Emission Point Reference NS2

No. of exceedences vs. No. of

samples N/A

Maximum Exceedence Value

vs. Limit Value

48.4dB(A) vs. 45dB(A) + 2dB(A) Note 1




Table of Contents

1. Introduction........................................................................................................................................ 41

2. Executive Summary ........................................................................................................................... 42

3. Sampling Methodology and Analytical Techniques........................................................................ 43

3.1 Instrumentation Used............................................................................................................ 43

3.2 Noise Survey Personnel ........................................................................................................ 43

3.3 Report Terminology.............................................................................................................. 43

3.4 Meteorological Conditions ................................................................................................... 44

3.5 Measurement Positions ......................................................................................................... 44

3.6 Measurement Locations ........................................................................................................ 44

4. Results ................................................................................................................................................. 46

5. Discussion ........................................................................................................................................... 50




1. Introduction

Environmental Efficiency Consultants Limited were commissioned by Ivax Pharmaceuticals to carry out an

environmental noise survey on this site in order to assess the level of noise generated by the sites during normal

operation.

This day time and night time environmental noise survey was carried out on the10th December 2008, in accordance

with the EPA Environmental Noise Survey Guidance Document.




2. Executive Summary

There are no major noise contributors for the Ivax Pharmaceuticals site. The nearest noise sensitive locations are a

private residence and a residential estate near Ivax Pharmaceuticals, which lies beyond other factories operating within

the industrial estate and would therefore be influenced by many other sources.

Only one result was found to exceed the limit by more than 2dB(A), i.e. the night-time reading at NS2. However, the

main source of noise during the monitoring was the morning traffic on the nearby roads (the survey was carried out

from 6am). It is therefore the opinion of this report that the company did not constitute a noise nuisance.

All the other readings were found to be compliant.




3. Sampling Methodology and Analytical Techniques

3.1 Instrumentation Used

The following equipment was used during the noise assessment:

Table 1: Equipment Used

Equipment Model

(Cirrus)

Serial No.

Sound Level Meter (SLM) (Type 1),

(with windshield attached)

CR:811B C16569FD

Microphone MK:224 20020028

Calibrator CR:511E 035066

Tripod N/A N/A

The sound level metre was calibrated to 94 dB(A) on-site immediately before measurement and checked on completion

of the study. No drift in calibration level was noted.

The Certificates of Calibration for the SLM and calibrator are provided in Appendix 2.

3.2 Noise Survey Personnel

Noise survey was undertaken by Stephen Ryan, MSc Environmental Science.

3.3 Report Terminology

The parameters used to assess the noise are as follows:

Leq (t): is the continuous equivalent sound level over a specified time (t), where t represented a 15-minute

period during this survey. This measure is used to give an indication of the average noise level over

the specified time period.

Continuous: noise produced without interruption.

Intermittent: noise that is punctuated with interruptions e.g. equipment operating in cycles or events such as single

passing vehicle




Impulsive: a noise of short duration (typically less than one second), the sound

pressure of which is significantly higher than the background; brief and

abrupt.

Tonal: noise that contains a clearly audible tone i.e. a distinguishable, discrete or continuous note (whine,

hiss, hum or screech, etc.).

The noise measurements were ‘A’ weighted and the time-weighting ‘Fast’ was applied (to equate to human ear

hearing).

3.4 Meteorological Conditions

Weather conditions during the survey did not affect the readings i.e. conditions were dry and wind speed was less than

5 m/s (the normal upper limit for taking measurements). The Sound Level Meter was also fitted with a windshield to

minimise interference from meteorological conditions.

3.5 Measurement Positions

All measurements were taken at:

• 1.2 – 1.5 m height above local ground level

3.6 Measurement Locations

The locations of noise monitoring points are described in the following table. All readings were taken during operating

hours when nearby equipment was being used.




Table 2: Location of sampling points for day and night survey (See Appendix 2)

Location Ref.

No. Geographical Description

N1 Southern boundary of Ivax facility

N2 North eastern boundary of Ivax facility

NS1 Eastern boundary of Industrial Estate, adjacent to Lismore

Park

NS2 Noise Sensitive Location at Eastern boundary of Industrial

Estate, adjacent to private residence.




4. Results

The night-time monitoring was performed on the 10th December 2008 from 6am and the daytime monitoring was

performed on the same day from 9am.

Tables 3 and 4 show the measurement results for the monitoring locations at Ivax Pharmaceuticals. Associated

particulars such as a description of the noise, interferences/background noise recorded, in each location are also

provided in the table.







Table 3: Results of on-site day time noise monitoring.

Parameter Parameter Parameter Location

No* Time

Leq L10 L90

Description of On-site Noise Sources Description of Off-site Noise

Interferences

N1 15 minutes 63.3 65.9 55.2 Some traffic entering and exiting the

site.

Road traffic

N2 15 minutes 64.1 63.7 57.5 The chillers and compressors create

some noise.

Road traffic

NS1 15 minutes 46.7 47.7 40.3 Off-site traffic on nearby road was the

main source of noise

Road traffic was the main source

of noise.



Road traffic was the main source

of noise.




Table 4: Results of on-site night time noise monitoring.

Parameter Parameter Parameter Location

No* Time

Leq L10 L90

Description of On-site Noise Sources Description of Off-site Noise

Interference

N1 15 minutes 62.5 62.3 47.9 Off-site traffic on nearby road was the


Morning traffic on the nearby roads

was the main source of noise.

N2 15 minutes 62.3 62.3 56.7 The chillers and compressors create

some noise.














5.




Discussion

All noise levels are relatively low at Ivax Pharmaceuticals. The limits are shown below.

Daytime: 55dB(A)

Night-time: 45dB(A)

A noise sensitive location is defined as:

Any dwelling house, hotel or hostel, health building, educational establishment, place of worship or entertainment, or

any other facility or area of high amenity which for its proper enjoyment requires the absence of noise at nuisance

levels.

The nearest noise sensitive locations are a private residence and a residential estate near Ivax Pharmaceuticals as can be

seen on the map in Appendix 2.

The day-time results of the noise survey are below the limit value of 55dB(A) at the noise sensitive locations (NS1 and

NS2).

The night-time noise levels at these noise sensitive locations were found to be slightly above the night-time limit of

45dB(A):

• At NS1: Leq, t = 46.7dB(A). This value does not exceed the limit value by more than 2dB(A) and is therefore

compliant according to Condition 3.4.1.

• At NS2: Leq, t = 48.4dB(A). This value is above the 2dB(A) allowance set out in Condition 3.4.1. However, the

main source of noise during the monitoring was the morning off-site traffic on the nearby roads and it is the

opinion of this report that the site did not constitute a noise nuisance.

Appendix 1 Certificate of calibration for the noise meter










Appendix 2 Site map

Noise Sensitive Location

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