2010 IPPC LICENCE REGISTER P0005-01 · 2010 Annual Environmental Report Page 1 of 67. ANNUAL ENVIRONMENTAL REPORT. 2010. IPPC LICENCE REGISTER P0005-01. SCHERING-PLOUGH (BRINNY) COMPANY

2010 Annual Environmental Report Page 1 of 67

ANNUAL ENVIRONMENTAL REPORT

2010

IPPC LICENCE REGISTER P0005-01

SCHERING-PLOUGH (BRINNY) COMPANY

Prepared By: Trevor Sheahan EHS Specialist -Environment Reviewed By: Adrian Murphy

Director Engineering

Approved By: Pat Finn

Manager, Environment, Safety and Industrial Hygiene

RESPONSIBLE CARE

Schering - Plough (Brinny) Company


CONTENTS: SECTION

PAGE 1. INTRODUCTION 3 2. SUMMARY INFORMATION ON EMISSIONS AND 8

ENVIRONMENTAL MANAGEMENT 2.1 EMISSIONS TO WATER 9 2.2 EMISSIONS TO AIR 11 2.3 WASTE SUMMARY 12 2.4 AGENCY MONITORING AND ENFORCEMENT 13 2.5 ENERGY AND WATER CONSUMPTION 15 2.6 ENVIRONMENTAL INCIDENTS 18 2.7 ENVIRONMENTAL COMPLAINTS 19

3. MANAGEMENT OF THE ACTIVITY 20

3.1 ENVIRONMENTAL MANAGEMENT PROG. REPORT 21 3.2 ENVIRONMENTAL MANAGEMENT PROGRAMME 24

3.3 POLLUTION EMISSIONS REGISTER 30 4. LIST II SUBSTANCES REDUCTION REPORT . 34 5. NOISE MONITORING REPORT. 37 6. SOLVENT & TOXICITY ANALYSIS ON TREATED EFFLUENT. 41 7. GROUND WATER MONITORING REPORT . 43 8. EUROPEAN POLLUTANT RELEASE AND TRANSFER REGISTER 58




SECTION 1

INTRODUCTION


1. INTRODUCTION 1.1 IPPC Licence Register No. P005-1 1.2 Name and Location of Site: Schering-Plough (Brinny) Company Brinny Innishannon Co. Cork. 1.3 Site Activities and Environmental Protection System: Site Activities: Fermentation, recovery, purification, sterile filling, freeze drying of protein based

pharmaceutical products. The current products are,

• Interferon alfa-2b • Remicade TM (Formulation only)

The protein product interferon is produced by fermentation using an appropriate

genetically modified organism. The protein is recovered in a crude form and purified by chromatographic techniques to produce a concentrated pure protein solution. The pure protein is dissolved in water for injection to which stabilisers and other excipients have been added. This is filled into sterilized vials that may then be freeze-dried. Other formulations are also produced in syringes or as a slow release product. The monoclonal antibody to produce Remicade is sourced externally.

Environmental Protection Systems: The production processes used are all aqueous based, are carried out at ambient

temperatures (or under slight refrigeration) and generally close to atmospheric pressure. They are, therefore by definition, clean technology processes.

The genetically modified organism used to produce the protein product is classified as

Class 1, that is, non-hazardous. It is unable to survive in the general environment as it requires factors for growth and multiplication, which are only present in the fermentation medium.



The fermenter is equipped with bacterially retentive filters, which will prevent the emission of any of the fermentation organisms. All micro organisms are killed following a fermentation batch so that no live GMO's will enter the wastewater treatment plant (WWTP). The waste fermentation medium contains the major portion of material from the site activities rich in BOD, nitrogen and phosphorus which is treated in the WWTP.

Trichloroacetic Acid (TCAA) is present in fermentation wastes as it is added to permit

efficient recovery of protein products. A Schering Plough patented treatment system is used to degrade the TCAA to inert or non-halogenated biodegradable products.

Sanitary wastes and other low strength wastes are also treated in the WWTP. The treated effluent is discharged to the Bandon estuary via an 8km pipeline. Storm water is segregated and collected and brought to a central monitoring chamber

where TOC, pH and temperature are continuously recorded. Any contamination of the storm water indicated by the monitoring instruments will automatically divert the storm water to a storm water/firewater retention pond where it may be held and returned to the WWTP for processing, if necessary. Uncontaminated storm water is discharged to the Brinny river.

The chief air emission is from the operation of the three boilers. The boilers run on natural gas. The boilers are well maintained and closely monitored to ensure optimum combustion conditions and minimise any possible air pollution.

Small amounts of isopropyl alcohol are used in all manufacturing areas for sanitisation purposes. This material will be emitted to atmosphere and surplus material in containers is discharged to the WWTP.

The small amount of hazardous wastes produced (principally from the quality control

laboratory operations) are stored in a dedicated storage area and all disposal is in accordance with Irish and International regulations. Industrial non-hazardous waste is sent to a sanitary landfill for disposal in accordance with Local Authority regulations. Recyclable materials are segregated and sent for recovery/recycling.

Waste sludges from the WWTP are pelletted for use as fuel.

Noise emissions are kept to a minimum by installation of low noise generating equipment, by provision of noise reduction measures and by regular monitoring and maintenance.



1.4 Environmental Policy Statement



1.5 Organisational Chart for Environmental Management



SECTION 2

SUMMARY INFORMATION ON EMISSIONS AND ENVIRONMENTAL MANAGEMENT



2.1 Emissions to Water:

Parameter

Mass Emissions (Kg) 2009

Mass Emissions

(Kg) 2010

Licensed Mass Emissions (Kg)

BOD 1148 830 14,600 COD 9384 6802 43,800

Suspended Solids 887 823 14,600 Kjeldahl Nitrogen (As N) 350 250 10,220

Nitrates (As N) 1079 713 5,840 Total Ammonia (As N) 183 101 5,840

Total Phosphorus (As P) 61 113 2,920 Toxicity (Toxic Units) <3.1 <3.1 10

TCAA 0.31 ND* 584 Zinc 10.72 12.05 146

Volume (M3) 164,148 172,212 292,000

*Not Detected in any effluent monitoring – Limit of detection for TCAA = 0.1mg/l

2.1.1 Non Compliances:

There were four instances of non-compliances in 2010. On four consecutive days the Nitrate ELV was exceeded. The exceedances had a common cause.

Date Non

Compliance Cause Corrective Action

16th-19th February 2010

Exceedance of Nitrate ELV from E1. ELV 20 mg/l Maximum Exceedance 25 mg/l

Fault in supplementary feed system ( molassess) resulted in imbalance in Carbon-Nitrogen ratio in the WWTP. As a consequence there was an excess Nitrogen in the WWTP which manifested as an exceedance over the 4 day period.

Supplementary feed system design modified to prevent reoccurrence. List of Environmental Critical Equipment generated. Maintenance, calibration routines developed and tracking system in place.



2.1.2 Effluent Pipeline Integrity Monitoring A number of inspections take place at intervals on the discharge effluent pipeline. A

summary of the outcomes of these inspections is outlined below

2.1.2.1 Monthly Inspection

A monthly inspection of the effluent pipeline was carried out in 2010 The pipeline land section was traversed and the foreshore section was visually inspected and results of these inspections were documented. No leakages and no damage to manholes, covers or supports was detected.

2.1.2.2 Annual Inspection Engineering Department personnel carried out an annual inspection of the pipeline. Manhole covers were lifted and the valves and vents were visually inspected for leaks and damage. No leaks were detected.

2.1.2.3 Monthly Flow meter check

There is a calibrated flow meter located at the end of the land section of the pipeline. A comparison is made between the totaliser readings for this flow meter and the totaliser readings for the treated effluent discharge flow meter at Brinny. The difference between both totalisers is within tolerance.

2.1.3 Underground Pipeline Integrity Monitoring

Inspection and testing of underground pipelines and associated manholes for Sanitary, Process and storm lines was completed on Brinny Site in Q3 2010. Phase 1 involved testing of underground pipelines using a combination of air hydro testing

Phase 2 involved conducting CCTV surveys of failed Phase 1 testing.

A full test report is held on file. In summary a number of defects were identifiedas follows: Sanitary lines: 14 pipelines with defect grades observed. Process lines: 9 pipelines with defect grades observed. Storm water lines: 16 pipelines with defect grades observed. An action plan to address the defects observed has been developed. Work is planned to commence in Q2 2011 and be complete by end Q3 2011.



2.2 Emissions to Air 2.2.1 Boiler Off gas

Parameter

Mass Emissions(Kg)

2009

Mass Emissions(Kg)

2010

Licensed Mass Emissions (Kg)

SOx 244 164 379,600 NOx 6902 7360 80,300 CO 46 21 14,600

2.2.2 Carbon Dioxide Carbon Dioxide emissions for 2010, reported separately to the Agency in the Annual

Installation Emissions Report (AIER) were 10,741 tons. These are summarised in the attached Pollutant Release and Transfer Register (PRTR).




2.3 Waste summary Full information on waste arising in 2010 is given in the attached e-PRTR. The following

is noteworthy:

• Non hazardous waste produced decreased by 70.2%. This was largely due to the fact that 2009 figures were inflated by removal of 1800t of soil and stones from construction activity on the site during that year. 2010 figures reflect a return to normal waste generation figures.

• 69.7% of non-hazardous waste was recycled or otherwise beneficially reused in 2010

vs. 29.0 % in 2009. Again, this is affected by the above.

• Off site recovery of non-hazardous waste includes pelletising of wastewater treatment plant sludge for use as a fuel, and recycling of cardboard, paper, glass and timber.

• Dewatered sludge is both biological and lime phosphate sludge.

• 19.4 % of hazardous waste was recovered in 2010. vs 44% in 2009. This reflects a return

to more normal rates of recovery for these streams. The high rate in 2009 was mainly due to large volume of Electrical and Electronic equipment waste sent for recovery in that period.

• Off site recovery of hazardous waste includes recovery of waste oils, electronic

equipment, batteries and used fluorescent light bulbs.


2.4 Agency Monitoring and Enforcement 2.4.1 Monitoring

Routine sampling of final effluent and surface water was performed by the EPA during 2010 on the following dates:

23 February 2010 18 August 2010

There were no significant differences between the company monitoring results and those obtained by the EPA.

2.4.2 Enforcement

An EPA Site Inspection was carried out on 22nd October by Ms. Siobhan McDonnell. A number of observations were raised in the course of the inspection and noted on the Site Inspection Report issued to the company on 8th November. Details on these and the actions taken are detailed below.

Ref Observation Corrective Action Required Status 1 No requirement in IPPCL

P005-01 which specifies frequency of integrity testing of bunds and underground pipelines. Testing of U/G drains had been undertaken in the two months preceding the inspection. Integrity testing of bunds has indicated that a number of bunds required repair. A repair schedule was in place with all bunds repaired by 31 Dec 2010.

Perform integrity testing at three year intervals as per the IPPC Guidance Note on Storage and Transfer of Materials for Scheduled Activities, EPA, 2004. Report on the results of the drains testing exercise. Maintain all testing records, results and verification of repairs done where required. Complete all bund repairs by Dec 31 2010.

All structures have been tested within a three year time frame. Site management program and procedures currently in review to incorporate the requirements of the Guidance Note See 2.1.3 above. Due to exceptional weather conditions it was not possible to complete all repairs by 31 Dec 2010. Repairs scheduled to be completed by end Q1 2011.



2 Financial Provision in foot of ELRA was in preparation

Submit the Financial Provision when prepared.

Financial Provision will be submitted when prepared

3 Site Incident Notification Procedure

Revise the procedure to include relevant Agency guidance.

Complete

4 WWTP Review Keep Agency informed of the outcome of the review

Review is ongoing. Angecy will be kept up to date with the outcome.

5 Transfer of Licence Agency reminded site that there may be a potential requirement for a Transfer of Licence in the event of a change in the Certificate of Incorporation Number of the organisation.

Brinny is aware of the potential requirement.



2.5 Energy and Water Usage 2.5.1 Energy – Gas/Oil Usage.

2007 2008 2009 2010

Natural Gas M3 5,699,082 5, 810, 656 5,700,652

5,547,643

Light Fuel Oil M3

1 8 7 3

Natural Gas is the main fuel source. It is used to produce steam for building heating, the production of pharmaceutical grade water by distillation and for the production of steam for equipment and material sterilisation. Gas usage is not directly related to product output and has a relatively low dependence on the number of batches of product produced.

Fuel energy consumption in 2010 decreased on 2009 figures (2.7%) due to decreased activity associated with Fermentation.

0

25000

50000

75000

MWhr

2007 2008 2009 2010Year

Fuel Energy Consumption



2.5.2 Energy - Electricity Usage

2007 2008 2009 2010

GWh/y 35 37 35 33

Electricity is used for water distribution, circulation in cooling towers, air compressors, ventilation fans, refrigeration systems, lighting, heating and dry heat sterilization. Electricity usage is not directly related to production output as most uses are to provide constant utility supplies on-site and to maintain temperature, humidity and air pressures within manufacturing areas - whether in use or unoccupied. However the decrease of 7.6% is due to decreased activity associated with Fermentation.

0.00

5.00

10.00

15.00

20.00

25.00

30.00

35.00

40.00

GWh

2007 2008 2009 2010Year

Electricity Usage



2.5.3 Water Usage

Water

000's m³

2007 2008 2009 2010 Abstraction 258 250 241 242 Discharge Treated 147 159 164 172 Discharge RO 86(1) 71(1) 57(1) 50(1) Evaporation 25 20 20 20

Water is used on site in cooling loops, production of pharmaceutical grade water by

softening, reverse osmosis (RO), distillation, steam generation, sanitary and potable use.

Water abstraction is metered as are certain uses and discharge of treated wastewater. The RO discharge figures provided above are for RO discharged to the storm water system, these are not metered. Water consumption in 2010 showed no significant increase or decrease on 2009 usage.

Note (1) RO discharge includes water used for activities connected with engineering activities: washing (roadways, vehicles etc.) and well flushing.




2.6 Environmental Incidents 2.6.1 Summary of incidents reported to the Agency during 2010.

Incident Date Action Taken Authorities Contacted

Malfunction of final effluent composite sampler

25 Mar 2010 Manual sampling conducted while repairs carried out. Repairs carried out and unit returned to service

EPA

Exceedance of ELV for Nitrate at Emission Point E1

18 Mar 2010 Incident investigated. Cause established (failure of supplementary feed dosing system). Corrective action taken.

EPA

Spillage of HCL from bulk storage vessel into bund

26 July 2010 Spillage contained within bund. Emergency Response Procedure activated. Full investigation conducted and corrective and preventive measures implemented

EPA HSA

Cork Co. Co.

2.6.2 Summary of incidents relating to emissions to atmosphere of HCFC’s and HFC’s


60kg estimated Leak of ISCEON 89 (R125 HFC) from a Refrigeration Unit

06 Mar 2010 System shutdown and repaired. Agreed with EPA to report in AER only


2.7 Environmental Complaints

Three complaints were received in 2010, all noise related.


Letter of complaint received relating to interference to local AM/LW radio reception

26 Mar 2010 Investigation conducted. Not site related.

EPA

Telephone complaint relating to loud noise experienced by neighbour during night

13 Apr 2010 Incident investigated. Cause established as due to operation of diesel pump. Corrective action taken.

EPA

Telephone complaint relating to loud noise experienced by neighbour during in early morning

08 Jul 2010 Incident investigated. Cause established as due to operation of refrigeration unit on delivery vehicle delivering food to site canteen. Corrective action taken.

EPA



SECTION 3

MANAGEMENT OF THE ACTIVITY



3.1 Environmental Management Programme Report 2010

The following is a summary of the work undertaken to carry out the commitments made in the EPA agreed Environmental Management Plan for 2010 .

Programme 1 (2010/01)

Complete the Water Mass Balance for the Site

Programme Objectives

• Identify all water inputs and outputs for the site • Create a full Water Mass Balance for the site. • Identify water saving opportunities etc.

Achievements versus targets

• All water inputs and outputs for the site identified • A full water mass balance completed for the site. • Further water monitoring opportunities identified

for potential savings


Bring the RFC for an online TOC and Phosphate Analysis System to Approval Stage and Commission and Install once Approved.


• Produce a final RFC for approval • Install and Commission once approved


• Best available technology based on cost benefit anlaysis was selected for Online TOC and Phosphate

• A final RFC was submitted for approval in 2009, but due to a hold on CAPEX projects was deferred to 2010.

• Based on production volume forecasts available in 2010, it was decided that online TOC & Phosphate Analysis was not required. The project has been held and can be reactivated in the event that changes in production volumes warrant the installation of such equipment.





Continue the 5 year Programme to optimise resource usage and reduce waste in WWTP operation


• Continue Track current usage v.historical usage for HCl,

Caustic and lime and the amount of sludge generated. • Consistently Maintain a 5:1 ratio of lime to phosphate

and achive the resulting savings


• Current usage v.historical usage for HCl, Caustic and

lime and the amount of sludge generated was tracked • Due to to the very low production volumes manufactured

in 2010 and the short duration of the fermentation campaign the loss of economies of scale meant that it was difficult to demonstrate savings.

• A 5:1 ratio of lime to phosphate was previously established in the latter stages of treatment having started at 6:1.

• The practice of pumping rainwater collected in TCAA storage area bunds directly to TCAA waste tanks and then treating the material through the TCAA removal system was reviewed. Data collected over a 4 month period showed that TCAA levels in the bunds were typically below the level of detection and that the material could safely be discharged to the WWTP. A new practice has been implemented where bund contents are stored in a dedicated vessel and the absence of TCAA confirmed prior to discharge to WWTP. This has eliminated the requirement to operate the TCAA treatment system outside of fermentation campaign with a consequent reduction in chemical ( NaOH, HCL, Lime ) and energy usage.



Complete an Application for a Review of the IPPC Licence


• Appoint an external consultant to help with this task. • Using historical review, desktop exercise and review of

documentation, complete the application. • Submit to EPA • Implement the requirements of the new licence • Get EPA approval for the CHP Project


• External consultant appointed to help with this task. • Historical review, documentation review carried out to

enable the IPPC application to be progressed • IPPC application form completed and held pending

decision on CHP approval for the site.


2009 Annual Environmental Report Page 24 of 67 3.2 Environmental Management Programme for 2011

Programme Number

Title

ENV2011/01 Protection of Surface Water and Groundwater

ENV2011/02 Waste Water Treatment Plant Optimisation

ENV2011/03 Continue the 5 year programme to Optimise Resource Usage and Reduce Waste in WWTP Operation

ENV2011/04 Environment Health and Safety Management Systems

ENV2011/05 Energy Reduction



PROJECT REFERENCE: ENV2011/01 PROJECT TITLE: To improve the facilities and operational controls associated with surface

water and groundwater protection systems on site Relationship to Objectives and Targets This programme is in line with the company environmental objective to protect surface water and groundwater. Reason for undertaking the project

• To ensure that systems to protect surface water and groundwater are adequately designed, constructed, inspected and maintained.

Target To have a structural integrity program for bunds, sumps and bulk chemical storage in place by end Q3 2011. Project Summary

• Generate full bund inventory including specifications of all bunds and bulk storage tanks • Develop and implement testing and inspection procedure including inspection and testing

schedule The programme will ensure that inspection and testing will be in accordance with IPPC Guidance Note on Storage and Transfer of Materials for Scheduled Activities

Responsibility The Facility Maintenance & Engineering Lead will have responsibility for this programme Time Frame The project completion date is Q3, 2011.




PROJECT REFERENCE: ENV2010/02 PROJECT TITLE: Waste Water Treatment Plant Optimisation Relationship to Objectives and Targets This project is in line with the company overall objective to implement best practice. Reason for undertaking the project To ensure that the WWTP is designed, operated and maintained so that 100% compliance can be assured. Target Zero non-compliances with IPPC licence Project Summary A front end study was conducted in 2010. The study goal was to assess the suitability of the existing WWTP configuration for the anticipated production forecast scenarios as these existed at the time. Projected production volumes for 2012 and beyond have been revised upwards and it is necessary to revisit the FES conclusions to ensure that these remain relevant to the new scenario. Responsibility The EHS Specialist Enviroment has responsibility for this project. Time Frame The project completion date is Q3, 2010.


PROJECT REFERENCE: ENV2011/03 PROJECT TITLE: Continue the 5 year programme to Optimise Resource Usage and Reduce

Waste in WWTP Operation Relationship to Objectives and Targets This project is in line with the company overall objective to minimise waste. Reason for undertaking the project To continue material usage and waste disposal savings in the Waste Water Treatment Plant and target in particlual lime usage and sludge disposal Target

• Bring about a further 10% reduction waste by Q4 2011

Project Summary

• Continue Track current usage v.historical usage for HCl, Caustic and lime and the amount of sludge generated.

• Consistently Maintain a 5:1 ratio of lime to phosphate and achive the resulting savings

Responsibility The EHS Specialist Environment together with The Process Engineer Utilities have responsibility for this project. Time Frame The project will be implemented by Q4, 2011




PROJECT REFERENCE: ENV2010/04 PROJECT TITLE: Implementation of Environmental Health and Safety Management Systems Relationship to Objectives and Targets This programme is in line with the company environmental objective on site management and control. Reason for undertaking the project

• To ensure that continuous improvement is maintained with respect to standards of site management and control in the area of Environment, Health and Safety.

Target To achieve compliance with 7 new Merck Global EHS Management Systems Project Summary

Merck Global EHS Organisation has developed 20 new EHS management programmes. Brinny has a target of implementing 7 of these by Q3 2011. These are listed below:

• Waste Management • Chemical Management • Management of Change • Contractor Management • High Risk Work • Process Safety • Industrial Hygiene

Responsibility The EHS Manager through the Business Units and Relevant Function Unit leaders have responsibility for this project. Time Frame The project completion date is Q3, 2011.


PROJECT REFERENCE: ENV2010/05 PROJECT TITLE: Energy Management Programme – Reduce Energy Consumption by 5% Relationship to Objectives and Targets This programme is in line with the company environmental objective to minimise resource use. Reason for undertaking the project

• To minimise resource usage and reduce costs Target To achieve a 5% reduction in energy usage by Q4 2011 Project Summary

A number of individual projects are being undertaken in pursuit of this goal. These are listed below. A full energy management programme is managed by the site Energy Champion.

• Upgrade Site Energy Monitoring System to a web based system • Install additional steam meters at identified usage locations • Replace Chill Water Medium supplying heat transfer fluid to OPS1 Compounding Panel • Upgrade OPS1 Chilled Water Control System • Install VSD on OPS1 Suit 3 Process Chiller Pumps and Cooling Tower A444 • Optimise Heating and Cooling setpoints on OPS1 and OPS2 HVAC systems

Responsibility The Energy Champion working through the Business Units and Relevant Function Unit leaders have responsibility for this project. Time Frame The project completion date is Q4, 2010.



3.3 Pollution Emissions Register 3.3.1 Introduction

Conditions 2.2, 2.3 and 2.4 of the IPPC Licence Register No. 5 specify requirements in respect of a Pollution Emissions Register (PER) and reporting on programmes for the control of specified materials emissions.

The conditions state:

2.2 The licensee shall prepare a Pollution Emissions Register (PER) for the activity.

The list of substances to be included in the PER shall be agreed with the Agency and shall, as a minimum, include List II substances used on site (E.U. Directive 76/464/EEC). As part of the PER, mass balances shall be prepared which shall quantify each substance listed, their overall usage, as well as the routes of disposal or loss of substances from the operation, including discharges to air, water, incineration off-site, landfill, recovery and recycling and loss in product.

2.3 The licensee shall, not later than 6 months from the date of grant of this licence

and each calendar year thereafter, prepare the programmes referred to in (2.1) and (2.2) above and submit these programmes to the Agency for approval. The results of all assessments, made in accordance with such approved programmes, shall be recorded and retained on-site for a period of not less than seven years and shall be available for inspection by authorised persons of the Agency. A report on these programmes, including the success in meeting approved targets, shall be prepared and submitted to the Agency on an annual basis.

3.3.2 List of PER Materials. The substances agreed with the Agency to be included in the PER are; 1. Nitrogen Compounds (Total). 2. Phosphate Compounds (Total).



3.3.2 Background on Substances in the PER. 3.3.2.1 Total Nitrogen:

Nitrogen is present in a large number of materials used on site. The nitrogen may be present in proteins, polypeptides or other organic nitrogenous materials or as an ammonium salt. All of these materials are non-volatile nitrogen compounds; therefore the loss of nitrogen from raw materials storage does not occur. On passage through the wastewater treatment plant most of the nitrogen is biologically converted to nitrogen gas and emitted to the atmosphere. As nitrogen gas is a major fraction of the atmosphere and the nitrogen in the original materials came from the atmosphere, the emission of nitrogen gas is not a polluting emission. Air is the major route of nitrogen emission; the two other routes are in treated effluent and in the biological sludge. Reduction in nitrogen inputs to the wastewater treatment plant is restricted by regulatory constraints. Nitrogen is also present in the oxidised form, as nitrate, in groundwater used on site and in nitric acid that is used for stainless steel passivation/cleaning, or as a cleaning regime.

3.3.2.2 Total Phosphorus: Phosphorus is present on site in materials as the phosphate group, either in ionic

materials such as phosphoric acid or alkali metal salts, or in natural organic materials (DNA/RNA, phospholipids etc). All of the materials are practically non-volatile and therefore evaporative losses need not be considered. On passage through the WWTP most of the organic phosphates are mineralised as soluble phosphates. A certain proportion of the phosphate will be taken up in biomass formed in the process.

The major phosphate removal takes place by addition of lime to form an insoluble

calcium phosphate sludge.



3.3.3 PER Summary Results

Pollution Emissions Register

Facility Name Schering Plough (Brinny) Company

Register No. P 0005-01

National Grid Reference W 5140 5957

Reporting Period January 2010 to December 2010

Production Units/Amounts Biotechnology Derived Pharmaceutical Products

Employee No. 520

Outputs

Pollutant Name CAS No. Input Gross Usage

Air MOM Liquid Effluent MOM Waste MOM Product MOM Recovery Treated Unaccounted

Nitrogen 7727-37-9 5275 5275 2661 B 963 M 1651 O 0 O 0 0 0

Phosphate 7723-14-0 3457 3457 0 B 113 M 3344 B 0 O 0 0 0



3.3.4 PER Substance Treatment Efficiency

Material Treatment Efficiency % Notes Nitrogen

81.7

1

Phosphorus

96.7

2

Note 1. Biological nitrogen removal efficiencies of approximately 80 – 90% are achieved at high plant loadings.

Note 2 There are two phosphate removal systems, the lime precipitation system and biological

uptake. The lime precipitation process removes the phosphorous content from the fermentation waste prior to the activated cludge WWTP. This precipitate is dewatered and the resultant sludge disposed of off site. This accounts for the vast majority of the phosphorous reduction. The remaining aqueous waste (including the centrate from the lime sludge dewatering process) is treated biologically where the phosphorous is removed by biological uptake.



SECTION 4

LIST II SUBSTANCES REDUCTION REPORT




4.1 Introduction

Condition 2.4 of the IPPC Licence Register No. 5 specifies that a programme for List II substance emission be put in place and reported annually.

"Condition 2.4. The licensee shall put in place a programme to identify methods by

which a reduction in the emissions of List II substances from the activity may be achieved. The licensee shall provide a report to the Agency on a yearly basis, setting out the reductions achieved with regard to these compounds in the previous year, and also setting out targets for improvement in the following year."

This report addresses the matters referred to in Condition 2.4 above. 4.2 List II Substances: List II is defined in EU Directive 76/464/EEC Annex as substances belonging to the

families and groups of substances in List I for which limit values have not been determined (the "list of 129" substances) and a list of substances or categories of substances belonging to families and groups of substances in a list provided.

The List II materials used on site which are deemed to fall within the above definitions

are:

Trichloroacetic Acid (TCAA) Nitrogen (Nutritive Compounds) Phosphorus (Nutritive Compounds) 4.3 Evaluation of Emission Reduction Methods for List II Substances 4.3.1 TCAA Reduction in TCAA use is not a practical option. The treatment system installed is BAT.

Test results of TCAA measurements are generally less than the analytical method detection level (0.1 mg/L). Work is concentrated on ensuring that the effluent TCA is consistently below the level of detection by ensuring that all TCAA wastes are routed to the TCAA treatment system.


4.3.2 Nitrogen

The system installed for nitrogen reduction is BAT. This is a biological nitrification / denitrification system. The system is meeting the design removal parameters. Nitrogen discharge was 0.96 tonnes in 2010 with a removal efficiency averaging 81.7%.

4.3.3 Phosphorus:

The system installed for phosphorous reduction is BAT. The primary phosphorus removal method in use is the precipitation of orthophosphate by lime to give insoluble calcium phosphate. This process removes greater than 99% of the soluble orthophosphate in high strength waste waters. This pre-treatment method has been shown to be more effective than post treatment precipitation. Further phosphate removal is obtained by phosphate uptake in the biomass in the biotower and the activated sludge system. Phosphate discharge in wastewater was 0.13 t in 2010 with a removal efficiency of 96.7 %



SECTION 5

NOISE MONITORING REPORT



5.1 Measurements Measurements were taken of the noise sources referenced in Schedule 4 (i) of the IPPC licence in Jun. and Dec. 2010 at the specified distance from each unit. A noise survey was carried out in April 2010 at the two boundary locations shown on the attached site map. These positions have been chosen as they represent the nearest site points to the nearest neighbours likely to be exposed to noise from the site. Noise monitoring was carried out at each site during normal production operations. Measures included: Leq (1 min), L(01), L(10), L(50), L(90) and 1/3 Octave band analysis of the noise levels at locations 1 and 2. 5.2 Summary of Reports: 5.2.1 Specified Equipment The IPPC Licence Schedule 4(i) values were obtained under worst case conditions. That is, where options such as different fan speeds or configurations are possible the highest emission was measured. This is not normally the operating configuration throughout the year. Values on certain pieces of equipment reflect different operational modes. Noise monitoring results for specified equipment on the site during 2010 were all within the required compliance range. 5.2.1 Noise Sensitive Locations The noise montoring carried out for 2010 shows no significant increase in noise levels emanating from the facility in comparison with historical results. The IPPC Licence granted for the facility does not set out noise limits for boundary locations. However the World Heath Organisation (WHO) recommends a guideline level of LAeq 55 dB during daytime hours and LAeq 45 dB during night-time hours. The daytime noise monitoring carried out in 2010 gave daytime LAeq values of 40.7dBA and 42.5dBA at Boundary Location 1 and 2 respectively The dominant noise source at these locations during the monitoring period was passing non-site traffic at Location 2 and birdsong at Location 1.




5.3 Noise Monitoring Results The full noise report is held on file. A summary of the results for specified equipment is given below. 5.3.1 Specified Equipment SOUND PRESSURE LEVEL

Source

Measured dBA

IPPC Licence Schedule 4(i) Value dBA*

Jun ‘10

Dec ’10

Cooling Towers Ops I

75.5

75.1

81

Cooling Towers Ops II

76.2

74.1

82

Cooling Tower Fermentation Building 13

Note (1)

Note (1)

81

Cooling Tower Fermentation/ Purification Buildings 8/18

76.0

66.8

75

Boiler(s)

Note (2)

58.4

74

Boiler Feed Pumps

77.7

82.5

83

Chillers Ops I Ext.

Note (3)

Note (3)

69

Glycol Chiller Building No's. 8/18

84.0

79.2

86

Water Distribution Pumps

72.9

72.9

74

De-carbonator

79.9

78.0

79

*The compliance limit is not more than 2dB(A) higher than the values given. Notes: (1) Decommissioned and removed from site (2) Alarm during monitoring (3) Chillers OPS 1 Extn. Have been permanently removed from service.


5.3.2 Location Map



SECTION 6

SOLVENT & TOXICITY ANALYSIS ON TREATED EFFLUENT



6.1 Solvent analysis

Solvent analyisis on treated effluent for 2010 was carried out by VOC analysis as outlined below on a composite sample and results are in line with typical analysis received over the past number of years as follows: Method Parameter Result

VOC by USEPA 524.2 All < 10 ug/l

Acetone < 0.5 mg/l Methanol < 0.5 mg/l Ethanol < 0.5 mg/l Isopropanol < 0.5 mg/l

VOC by GC-FID

Acetonitrile < 0.5 mg/l

6.2 Toxicity testing Toxicty testing was carried out biannually on composite samples on a range of species and gave the following results :

Species Toxic Units

48 h LC 50 to Tisbe battagliai <3.1

15 min EC 50 to Vibrio fischeri <2.2

5 min EC50 to Vibrio fischeri <2.2




SECTION 7

GROUNDWATER MONITORING REPORT


7.1 Introduction

Condition 9.3 of Integrated Pollution Control Licence Register No. 5 requires that,

"9.3.1 The licensee shall maintain groundwater monitoring wells at the following locations:

MW-1S, MW-1D, MW-2S, MW-3S, MW-3D, MW-4S, MW-4D. 9.3.2 The licensee shall sample and analyse these monitoring wells in accordance with

Schedule 5(ii) of this licence. " Schedule 5(ii) Monitoring Requirements

Parameter Monitoring Frequency Trace Organics Major Anions Major Cations Ammonia (as NH3) Nitrate (as N) Individual heavy metals

Yearly Bi-annually Bi annually Bi-annually Bi-annually Bi-annually

The monitoring wells specified above were installed as part of a Schering-Plough

environmental management project in 1991. Monitoring of water in these wells has been carried out since then and monitoring results presented in our IPPC Application in 1994 and in the 1995 IPC report.

The well positions are such that both up gradient and down gradient of the presumed

groundwater flow are intercepted to provide a comprehensive view of groundwater conditions.

Because of a known semi-permeable clay layer on site most positions include a shallow and deep monitoring well. Due to the natural water table levels, well MW-1S does not normally contain water. Only a shallow well is present at the southern end of the site (MW-2S) due to the local geology.

Monitoring well depths and a map of the monitoring well positions are provided below.




7.2 Monitoring Well Results 7.2.1 Monitoring Wells Results Summary

Trace Organics measured annually by VOC analysis on ground water samples for 2010 are in line with typical analysis received over the past number of years as follows:

Method Parameter Result

VOC by USEPA 524.2 All < 10 ug/l

Acetone < 0.5 mg/l Methanol < 0.5 mg/l Ethanol < 0.5 mg/l Isopropanol < 0.5 mg/l

VOC by GC-FID

Acetonitrile < 0.5 mg/l

Major cations and Anions measured bi-annually show that Monitoring Well 3S has a

higher conductivity than the other monitoring wells. The conductivity is due to elevated chloride levels when compared to the other monitoring wells.

Ammonia and Nitrate and Heavy metal results measuered bi-annually show no significant change from ’09 results. Details of one set of analysis of samples taken in August 2010 are attached. These and all other ground water monitoring results are held on file.

7.3 Monitoring Wells Brinny Site

There are four monitoring well locations on site. Each location has either one or two monitoring wells. A site plan showing the locations of the wells is attached.

Monitoring Well Depths

Well No. Depth metres

MW-1S Dry

MW-1D 7.2

MW-2S 4.2

MW-3S 4.6

MW-3D 5.0

MW-4S 6.1

MW-4D 6.5

2010 Annual Environmental Report Page 46 of 67 7.4 Ground Water Monitoring Wells location map

3S,3D

2S 4S,4D

1S,1D


2010 Annual Environmental Report Page 47 of 67 7.5 Groundwater Monitoring Well Monitoring Results























SECTION 8

EUROPEAN POLLUTANT RELEASE AND TRANSFER REGISTER


2010 Annual Environmental Report Page 59 of 67 8.1 AER/PRTR Emissions Data


















Documents

2010 IPPC LICENCE REGISTER P0005-01 · 2010 Annual Environmental Report Page 1 of 67. ANNUAL ENVIRONMENTAL REPORT. 2010. IPPC LICENCE REGISTER P0005-01. SCHERING-PLOUGH (BRINNY) COMPANY