1. INTRODUCTION 3 2. COMPANY BACKGROUND 3 3. SUMMARY INFORMATION 6

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2 Covidien Pharmaceuticals Dublin AER 2012 Table of Contents 1. INTRODUCTION 3 2. COMPANY BACKGROUND 3 3. SUMMARY INFORMATION Self Monitoring Data Emissions to Atmosphere Emission to Sewer Emissions to Surface Water Waste Resource Consumption 8 4. ENVIRONMENTAL INCIDENTS AND COMPLAINTS Incidents Complaints MANAGEMENT OF THE ACTIVITY Covidien Pharmaceuticals Dublin Environmental Management System Environmental Management Programme Report and Proposal Pollution Emission Register Report and Proposal Other Significant Environmental Activities EPA Inspections and Sampling External Environmental Management System Audits LICENSE SPECIFIC REPORTS Noise Monitoring Report Groundwater Monitoring Report Sump Inspection Report Bund Inspection Report Report on List I and II Substance Reductions Review of Closure, Restoration and Aftercare Management Plan Review of Environmental Liabilities Risk Assessment Energy Efficiency Audit CONCLUSIONS 17 Page 1 of 16

3 Covidien Pharmaceuticals Dublin AER 2012 List of Appendices Appendix 1 Electronic Environmental Data Submission Appendix 2 IPPC Emissions Summary Appendix 3 EMP for (Performance for 2012 and proposed amendments for 2013) Appendix 4 Pollution Emission Register Report 2011 Appendix 5 Ground Water Monitoring Report Appendix 6 CRAMP- April 2007 Appendix 7 Summary of Environmental Liability Risk Assessment Page 2 of 16

4 Covidien Pharmaceuticals Dublin AER INTRODUCTION This is the Annual Environmental Report of Mallinckrodt Medical Imaging Ireland (trading as Covidien Pharmaceuticals Dublin) as per Condition of the Integrated Pollution Control Licence No. P This Annual Environmental Report 2012 has been prepared using the guidelines from the Environmental Protection Agency s publication Integrated Pollution Control Licensing, Guidance note for Annual Environmental Report, published in October As specified in the EPA AER guidance document all summary information is presented for the previous calendar year, 2012, unless otherwise specified. A submission of summary information in electronic format will be made to the EPA, as requested in the guidance document. This can be found located in Appendix COMPANY BACKGROUND Mallinckrodt Medical Imaging Ireland, trading as Covidien Pharmaceuticals Dublin, is located in Damastown Industrial Estate, Mulhuddart, Dublin 15. The plant is a continuous manufacturing pharmaceutical facility which produces Ioversol, a bulk API for Optiray, an X-ray Contrast imaging Agent. Production began at the site in 1993 after a 16 month construction project. The plant was built on a green-field site. The original development was subject to a capacity expansion project 5 years later in 1998 converting the chemical processing to a new Alternative Synthesis process. The site was further expanded in 2008 increasing production of Ioversol by 30%. There are 101 employees across management, production, engineering, quality, finance and administration with production operating on a four shift rota 24 hours/day for approximately 355 days per year. In July 2007, Tyco Healthcare split from Tyco International evolving to the new corporation Covidien. With this, the site is now formally trading as Covidien Pharmaceuticals Dublin as reported formally to the EPA in January Our current Legal entity remains as Mallinckrodt Medical Imaging Ireland. Page 3 of 16

5 Covidien Pharmaceuticals Dublin AER 2012 The site covers a total area of 120,000m 2, 60,000m 2 of which has been developed by the company. The remaining land is reserved. The developed area contains: Security Boiler room; Administration (with canteen); Cooling Tower; Fire Water Retention Pond; Tank Farm; Laboratories; Waste Water Treatment Plant; Warehouse; Water Storage; Process Building; Drum Store; Maintenance Building; Carparks. The site has been licensed by the Environmental Protection Agency (EPA) since 1995, and is accredited to ISO14001:2004 Environmental Management System Standard since The scope of this management system is the manufacture and testing of Ioversol, analytical testing of Optiray and related services. The site Environmental, Health and Safety policy can be found overleaf. It was updated in November 2011 and communicated to all staff operating from the site. It is also posted around the site. Page 4 of 16

6 Covidien Pharmaceuticals Dublin AER 2012 Page 5 of 16

7 Covidien Pharmaceuticals Dublin AER SUMMARY INFORMATION 3.1 Self Monitoring Data Emissions to Atmosphere All emissions to air were within the terms of the license. The boilers operated without visible smoke emissions. In 2012, the new ethylene oxide abator was commissioned. This has resulted in increased EtO abatement reliability and decreased energy usage. A summary table of the air emissions is included in Appendix 1 and has been submitted in electronic form to the Agency. The full list of parameters of our license as they relate to air monitoring water from the discharge points are included below and in Appendix 2. Emission Point Parameter IPPC Mass ELV (kg/yr) Mass Emission 2011 (kgs) Mass Emission 2012 (kgs) AB-02 & AB-06 Total Dust (kg/yr) ABAS-02 ABAS-02 AB-03 ABAS-01 TA Luft Organics Class 1 TA Luft Organics Class 2 TA Luft Class 3 Vapour Inorganics TA Luft Class 3 Carcinogens * * * * AB-04 & AB-05 NOx AB-04 & AB-05 CO *with respect to 2011 emission values, an error was made by the accredited laboratory when calculating the concentration of the gas streams from ABAS-02, AB-03 and ABAS-01. As a result of this, the values in the 2011 AER are incorrect. In consultation with the EPA inspector for the site, the 2011 figures have been updated with the correct values obtained from the laboratory. A copy of the explanation of the error has been saved electronically. This error has not been repeated in the 2012 figures Emission to Sewer The summary information required for this AER has been submitted electronically to the Agency. A copy of this submission is included in Appendix 1. The full list of parameters of our license as they relate to monitoring of waste water from the discharge point to sewer is included below and in Appendix 2. There were no non-compliances relating to emissions to sewer in All parameters were within IPPC limits. Page 6 of 16

8 Covidien Pharmaceuticals Dublin AER 2012 As per condition 6.5 of the IPPC license, Microtox and Respirometry were approved as the appropriate testing regimes for toxicity testing of discharges to sewer. All results were within IPPC limits specified. A summary of compliance is provided below. Parameter Frequency IPPC Mass ELV (kg/yr) Mass Emission 2011 Mass Emission 2012 Flow Continuous m m m 3 BOD Monthly COD Monthly Suspended solids Monthly Sulphates as SO4 Monthly Copper as Cu Monthly Fats, Oils, Grease Monthly Phosphates as P Monthly Iodinated Compounds Monthly Chlorides Monthly Ammonia as N Monthly Nitrates as N Monthly Kjeldahl Nitrogen Monthly Total Nitrogen Monthly Parameter Frequency IPPC ELV Emission 2012 Temperature Continuous 42 o max ph Continuous max Toxicity Quarterly 10 TU < 2.2 Organic Solvents Biannually Solvent Screen Process No elevated results Emissions to Surface Water All emissions to Surface water were monitored in accordance with our IPPC License. On line ph and TOC analysers are in place on the surface water discharge to the River Tolka and are fed back to the DCS plant control system. These are configured to activate an alarm in the event of an excursion of ph or TOC and automatically divert any surface water flowing to the surface water to the Firewater Retention Pond. All diversions in 2012 were fully investigated, and were normally as a result of TOC pump issues due to environmental conditions or ingress of detritus to the TOC monitoring system. Page 7 of 16

9 Covidien Pharmaceuticals Dublin AER 2012 There were two rank 1 events, one relating to product discharge to the production roof and the other relating to a leaking surface water drain, during 2012 which required comprehensive investigation by the site (detailed in section 4.1 below). Appropriate corrective and preventative actions were taken as a result of these incidents to prevent reoccurrence Waste Overall the waste recycling on site was 38% in 2012 in comparison to 36% in 2011 and, 34% in A summary table of the waste generated is included in Appendix 1 as part of PRTR reporting, and has been submitted electronically to the Agency Resource Consumption Data for energy usage and water consumption is included in the Environmental Data Submission included in Appendix 2. Based on tonnes of product produced, these are the metrics for resource consumption. Natural Gas use is subject to production efficiency work that is being carried out and is in line with Greenhouse Gas Permit allowance and permit. Parameter Unit Light Fuel Oil M 3 /yr Natural Gas M 3 /yr 3,723,464 3,641,225 3,970,361 M 3 /Kg Product Electricity MWhr MWhr/kg Product Municipal water use m 3 /yr 429, , ,507 m3/kg Product Page 8 of 16

10 Covidien Pharmaceuticals Dublin AER ENVIRONMENTAL INCIDENTS AND COMPLAINTS 4.1 Incidents Please see below the summary of environmental incidents in 2012 as defined under EPA guidance on reporting of incidents. As part of the site IPPC Licence there is a requirement to inform the Agency of any release to atmosphere from any potential emission point; any emission which does not comply with the requirements of the licence; any malfunction or breakdown of control equipment or monitoring equipment which is likely to lead to loss of control of the abatement system; and any incident with the potential for environmental contamination of surface water or groundwater, or posing an environmental threat to air or land, or requiring an emergency response by the Local Authority. Incidents were reported to the EPA as required over the course of the year. All incident reported to the EPA were incidents to the EPA were categorized as Rank 1 Environmental incidents. Date Issue Corrective Action Preventive Actions 10/01/2012 A fault was identified on the submersible pump that supplies water to the surface water TOC analyser. The diverter valve was automatically closed. The faulty pump in normal operation supplies the TOC analyser with surface water for analysis. It had an electronic fault. This event was reported as a Rank 1 event to the agency. 19/01/2012 Vapours released from a damaged plate on the scrubber vent line (SC- 2051) to the Abator (AB- 2057). Potential for ethylene oxide (EtO) vapours to escape from the damaged place located on the line. This event was reported as a Rank 1 event to the agency. 28/01/2013 Surface water monitoring ph dropped below its critical alarm limit of ph of 6. A sample of surface water was taken and analysed by Quality Control. The result was 7.8. The ph No impact to environment. Diverter valve was automatically closed. Negligible impact to the environment All operations connected tosc had cycle held (gone to safe state) immediately. A new plate was installed and is functioning as required. No impact on the environment. The ph probe was replaced as it was not reading similar to the sample analysed by Quality Control. The new ph probe was calibrated. The ph trend was monitored for The pump was replaced with a new spare from stock Spade off all redundant lines present on the system. Action complete. No preventive actions identified. Page 9 of 16

11 Covidien Pharmaceuticals Dublin AER 2012 Date Issue Corrective Action Preventive Actions probe was reading a lower ph value. This event was reported to the agency as a rank 1 event. 31/01/2012 A scheduled calibration was conducted In the surface water monitoring ph analyser AT The instrument was reading erratically from reviewing the instrument trend. The sensor was placed in buffer solution to check for accuracy. It failed to stabilise. This event was reported to the agency as a Rank 1 event. 01/03/2012 An instrument issue caused a bypass of the ethylene oxide abator AB All reactors venting to the abatement process went into a safe operating condition immediately. Ethylene oxide contained within the abator inlet pipework was directed to atmosphere as a result of the bypass. The outlet monitoring analyser recorded a value exceeding the ELV. This was reported to the agency as a Rank 1 event. 29/03/2012 A discharge was noted in the eastern drainage ditch. It was discovered that the Tank Farm sump had overfilled and leaked out via a broken surface water pipe. It was identified as being Foamtrol which is not hazardous to the environment. This event was reported to the agency as a Rank hours after the calibration and was working effectively. No impact to the environment. The ph probe was replaced. The new ph probe was calibrated. The ph trend was monitored for 24 hours after the calibration and was confirmed to be working effectively. Minor environmental impact. The bypass scenario was rectified by configuring the inlet analyser range. The eastern drainage ditch was immediately blocked from discharging further with an inflatable bung. The ditch was then pumped out to a road tanker for disposal offsite. The source of the discharge was identified as coming from the Tank Farm Sump. An inspection of the sump followed by a CCTV camera survey of the pipework around the sump also took place. No preventive were identified. A root cause analysis investigation was undertaken. A new design inlet analyser is being installed currently. Reset the alarm limit condition and document on plant change control. A root cause analysis was conducted into the event All corrective and preventative actions identified in the root cause analysis are complete. Page 10 of 16

12 Covidien Pharmaceuticals Dublin AER 2012 Date Issue Corrective Action Preventive Actions 11/06/2012 The surface water TOC analyser (AI ) alarmed above 40ppm and automatically closed the storm water diverter valve. It was found that pressure jet washing of the surface water draining system disturbed decaying vegetative matter resulting in the elevated TOC reading. This event was reported to the agency as a Rank 1. 02/07/2012 The storm water diverter valve AT failed in service and was manually diverted to the on-site fire water retention pond. Reported as a Rank 1 event to the agency. 11/07/2012 The surface water TOC analyser (AI ) failed in service. The storm water diverter valve was manually diverted to the on-site water retention pond. Reported to the agency as a Rank 1 event. 06/08/2012 The surface water TOC analyser (AI ) failed in service. The storm water diverter valve was manually diverted to the on-site water retention pond. Reported to the agency as a Rank 1 event. No environmental impact. The power washing was postponed during the investigation and the TOC reading returned to normal. The storm water diverter valve was manually diverting to the on-site water retention pond. No environmental impact. External contractor conducted an inspection and determined that the relay had failed. A new relay was installed. Equipment was returned to normal service. No environmental impact. Inspection of the instrument conducted and repair conducted by designated contractor. This was unconnected to the event above. No environmental impact. All trends associated with the surface water TOC were reviewed and no elevated TOC readings were identified. Equipment was put back into normally operation. This was unconnected to the previous two events above. Engineering department was informed that work on the surface water system must be communicated to the EHS department before commencing work. Action complete. No preventive actions were identified No preventive actions were identified No preventive actions were identified. 22/08/2012 On the 22nd of August 2012 elevated TOC levels were observed in the Surface Water Monitoring Pit (SW-1). On the 03rd September 2012 the source of the elevated levels were discovered after thorough investigation due to an overflow from a reaction vessel, releasing product onto the roof of Surface system was immediately diverted to the onsite firewater retention pond for safe holding. *please note that approximately 7 liters of methanol were estimated to have been discharged to the roof. This has been included in the accidental release section of the PRTR. A root cause analysis was carried out and preventative actions identified including hard piping roof drains to process sumps. The level alarm limits on the reactor were also improved. Page 11 of 16

13 Covidien Pharmaceuticals Dublin AER 2012 Date Issue Corrective Action Preventive Actions the production building which subsequently made its way to the surface water drains. The surface water was diverted to the onsite firewater retention pond for the duration of the event. The firewater retention pond was then diverted to the waste water treatment plant for treatment prior to discharge to the WWT /10/2012 An unexpected power failure took place. This resulted in the continuous monitoring instruments on the WWTP going down. For a period of approximately 4 hours there was no visibility on the instruments. All monitored levels were normal prior to this failure and subsequently returned to normal. This event was reported to the agency as a Rank 1 event. 12/12/2012 Ethylene Oxide (ETO) analyser A I range was found to be 0-50ppm when the DCS is ranged 0-200ppm. This resulted in the site overestimating the levels of EtO by a factor of 4. No impact on the environment as all process immediately went to a safe state. Repair works conducted on the Medium Voltage (MV) breaker. The MV breaker was switched on and all the other Low Voltage (LV) breakers were turned on one by one and no other issues identified. The EtO analyzer AI was re-ranged. Develop an MV Switching procedure. Purchase suitable arc flash PPE in consultation with EHS Department. Actions underway. QSL (external calibration company) will add in an extra check to their calibration to check the ppm reading of their span gas at our Delta V screen and not just at the transmitter this will show that both the transmitter and DeltaV have the same range. Conduct a review with the external contractor to check as part of the standard calibration program, before signing off on maximo, that the work was completed satisfactorily. Actions Underway. 4.2 Complaints No environmental complaints were received in Page 12 of 16

14 Covidien Pharmaceuticals Dublin AER MANAGEMENT OF THE ACTIVITY 5.1 Covidien Pharmaceuticals Dublin Environmental Management System Covidien Pharmaceuticals Dublin is certified to the Environmental Management System Standard ISO14001:2004, and is audited externally to ensure ongoing conformance with this standard. The Plant Manager has overall responsibility for environmental management at the site with designated responsibilities for performance and compliance support assigned to the EHS Manager. The EHS Department comprises of three full time employees- EHS Manager, EHS Engineer and EHS Officer. The key elements of the environmental management system comprises of identifying environmental aspects associated with site activities, the determination of suitable operational controls (engineering and administrative); the identification of pertinent legal requirements; definition and implementation of objectives and targets; ongoing monitoring of performance and compliance; and management review of performance on a periodic basis. Emergency planning and good internal stakeholder structures are also features of the system. These elements are structured to meet the requirements of both ISO14001 and Covidien Corporate requirements to provide for continual improvement in environmental performance. 5.2 Environmental Management Programme Report and Proposal The 5 year EMP for with 2012 performance and proposed amendments for 2013 is included in Appendix 3. In line with ISO 14001, all objectives in the five year plan are based on the significant environmental aspects of the site and related compliance requirements. 5.3 Pollution Emission Register Report and Proposal As per IPPC Condition 2.4, the substances for the 2011 Pollution Emission Register are: Total Nitrogen (CAS No ) 2-Chloroethanol (CAS No ) It is proposed that in 2012 Total Nitrogen and 2-Chloroethanol will be reported. Copies of the PER are in Appendix 4. Page 13 of 16

15 Covidien Pharmaceuticals Dublin AER Other Significant Environmental Activities EPA Inspections and Sampling There was one site EPA inspection carried out in A report of inspection was issued and all actions are complete. There were visits by the EPA to take waste water treatment samples. A split sample was taken by Covidien Pharmaceuticals Dublin each time. There were no noncompliances associated with samples taken External Environmental Management System Audits An ISO14001:2004 surveillance audit was carried out in July and December There were no non-conformances raised. Page 14 of 16

16 Covidien Pharmaceuticals Dublin AER LICENSE SPECIFIC REPORTS There are a number of license specific reports to be provided as part of the site IPPC license on a periodic basis. A summary of the status of these follows: Report Type License Requirement Report Due in AER Sump Integrity Every 3 years AER 2013 Environmental Noise Monitoring Every 3 years AER 2013 Groundwater Monitoring Report Every 2 years AER 2012 (Attached) Bund Integrity Every 3 years AER Noise Monitoring Report No environmental noise monitoring was required in 2012 in line with the license requirements. The last assessment was carried out in From previous background noise surveys undertaken when the plant was shut down, background noise levels at the nearest Noise Sensitive Location are high due to traffic on the nearby Navan dual carriage way and proximate industrial activity in Damastown Industrial estate. The 2010 noise survey indicated that the contribution made to the noise environment by the Covidien facility was observed to be minimal. The next environmental noise survey will be carried out in 2013 in line with license requirements. 6.2 Groundwater Monitoring Report Groundwater monitoring was conducted in 2012 in line with the license requirements. The report is located in Appendix 5. Results in 2012 were observed to be broadly consistent with all previous reports. 6.3 Sump Inspection Report A Sump Inspection report was commissioned in 2011 in line with IPPC requirements. 6.4 Bund Inspection Report A Bund Inspection report was commissioned in 2010 in line with IPPC requirements. The next Bund Inspection survey will be carried out in 2013 in line with license requirements. Page 15 of 16

17 Covidien Pharmaceuticals Dublin AER Report on List I and II Substance Reductions This report was completed in 2004 and is available for inspection on site. The principal conclusion was that a ca. 7.5 % reduction in the amount of 2-Chloroethanol was planned to be achieved from mid 2002 onwards. The actual achieved was ca % in The process is now fully optimised in terms of the use of 2-Chloroethanol. 6.6 Review of Closure, Restoration and Aftercare Management Plan The Residuals Management Plan (RMP) was submitted to the Agency in December 2002 and approved by the Agency in March This was subject to confirmation of the financing of the plan which was provided to the Agency in June Subsequently, an updated RMP was then submitted for approval to the Agency in April A Closure, Restoration and Aftercare Management Plan (CRAMP) was then reviewed by an independent consultant and submitted to the Agency for agreement in May Financing of the plan continues to be subject to corporate review with inflation added on an annual basis (currently 5% annually). A copy of the CRAMP report is located in Appendix Review of Environmental Liabilities Risk Assessment An Environmental Liabilities Risk Assessment review was conducted in April This was submitted for agreement to the Agency for agreement in May A copy of the Environmental Liabilities Risk Assessment report is located in Appendix Energy Efficiency Audit In 2008, an energy map project was undertaken on site in conjunction with SEI. A key focus for 2009 was energy reduction in line with the projects identified as part of the mapping exercise. Following from implementation of these improvements in 2009, investigations and changes in the design of steam production and condensate systems has led to significant savings in energy. A gas reduction project which entailed installation of alternative energy technology for process water removal reducing the requirement for steam processing led to short listing for an energy award with SEI. Page 16 of 16

18 Covidien Pharmaceuticals Dublin AER CONCLUSIONS In ensuring ongoing compliance of the site to the IPPC License, and the ongoing commitment of the company to the pursuit of excellence in environmental performance, the site continued to demonstrate strong environmental performance in The site has continued to succeed in progressing and delivering on the agreed environmental programme with excellent success especially in the areas of resource optimisation and energy reduction. This was primarily as a result of the implementation of energy projects following from the site energy audits and investigations carried out over 2007 and In particular there has been significant capital investment in 2012 in remediation works to the site s underground drainage system. Increased management of environmental monitoring criteria at plant level, and an increased focus on compliance criteria embedded to the company has resulted in increased ownership and awareness of environmental requirements and performance across the plant. The site wishes to continue to operate to a very high standard in environmental performance, and is committed to maintaining good stakeholder relations with the Agency, public and surrounding community in providing the highest level of environmental protection. Page 17 of 16

19 Covidien Pharmaceuticals Dublin AER 2012 APPENDIX 1 ELECTRONIC ENVIRONMENTAL DATA SUBMISSION

20 Sheet : Facility ID Activities AER Returns Workbook 28/3/ :35 PRTR# : P0050 Facility Name : Mallinckrodt Medical Imaging - Ireland Filename : P0050_2012.xlsm Return Year : /03/ :35 REFERENCE YEAR 2012 Guidance to completing the PRTR workbook 1. FACILITY IDENTIFICATION Parent Company Name Mallinckrodt Medical Imaging - Ireland Facility Name Mallinckrodt Medical Imaging - Ireland PRTR Identification Number P0050 Licence Number P Version Waste or IPPC Classes of Activity No. class_name The manufacture of pesticides, pharmaceuticals or veterinary products and their intermediates, not included in paragraphs 5.12 to The manufacture of pesticides, pharmaceuticals or veterinary products and their intermediates, not included in paragraphs 5.12 to Address 1 Damastown Address 2 Mulhuddart Address 3 Dublin 15 Address 4 Dublin Country Ireland Coordinates of Location River Basin District IEEA NACE Code 2120 Main Economic Activity Manufacture of pharmaceutical preparations AER Returns Contact Name Brenda Connolly AER Returns Contact Address brenda.connolly@covidien.com AER Returns Contact Position EHS Manager AER Returns Contact Telephone Number AER Returns Contact Mobile Phone Number AER Returns Contact Fax Number Production Volume Production Volume Units kgs Number of Installations 1 Number of Operating Hours in Year 0 Number of Employees 101 User Feedback/Comments Web Address 2. PRTR CLASS ACTIVITIES Activity Number Activity Name 50.1 General AER Returns Workbook 4(e) Installations using a chemical or biological process for the production on an industrial scale of basic pharmaceutical products 3. SOLVENTS REGULATIONS (S.I. No. 543 of 2002) Is it applicable? 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 site Do you import/accept waste onto your site for onsite treatment (either recovery or disposal activities)? This question is only applicable if you are an IPPC or Quarry site PRTR# : P0050 Facility Name : Mallinckrodt Medical Imaging - Ireland Filename : P0050_2012.xlsm Return Year : 2012 Page 1 of 1

21 Sheet : Releases to Air AER Returns Workbook 28/3/ : RELEASES TO AIR Link to previous years emissions data PRTR# : P0050 Facility Name : Mallinckrodt Medical Imaging - Ireland Filename : P0050_2012.xlsm Return Year : /03/ : SECTION A : SECTOR SPECIFIC PRTR POLLUTANTS RELEASES TO AIR Please enter all quantities in this section in KGs POLLUTANT METHOD QUANTITY Method Used AB-04/AB-05 Boilers ABAS-01 AB--03 ABAS-02 No. Annex II Name M/C/E Method Code Designation or Description Emission Point 1 Emission Point 2 Emission Point 3 A (Accidental) Emission Point 4 T (Total) KG/Year KG/Year F (Fugitive) KG/Year 03 Carbon dioxide (CO2) C ETS Nitrogen oxides (NOx/NO2) M CRM US EPA CTM Non-methane volatile organic compounds (NMVOC) M EN 13649: Sulphur oxides (SOx/SO2) M CRM US EPA CTM * Select a row by double-clicking on the Pollutant Name (Column B) then click the delete button SECTION B : REMAINING PRTR POLLUTANTS RELEASES TO AIR Please enter all quantities in this section in KGs POLLUTANT METHOD QUANTITY Method Used AB-04/AB-05 Boilers ABAS-01 No. Annex II Name M/C/E Method Code Designation or Description Emission Point 1 Emission Point 2 A (Accidental) T (Total) KG/Year KG/Year F (Fugitive) KG/Year 02 Carbon monoxide (CO) M CRM US EPA CTM Ethylene oxide M CRM BS EN 13649: * Select a row by double-clicking on the Pollutant Name (Column B) then click the delete button SECTION C : REMAINING POLLUTANT EMISSIONS (As required in your Licence) RELEASES TO AIR Please enter all quantities in this section in KGs POLLUTANT METHOD QUANTITY Method Used AB-02 AB-06 AB-03 ABAS-02 ABAS-01 Pollutant No. Name M/C/E Method Code Designation or Description Emission Point 1 Emission Point 2 Emission Point 3 Emission Point 4 A (Accidental) Emission Point 5 T (Total) KG/Year KG/Year F (Fugitive) KG/Year 210 Dust M CRM BS EN TA luft carcinogenic substance class 3 M CRM BS EN 13649: TA Luft organic substances class 1 M CRM BS EN 13649: TA Luft organic substances class 2 M CRM Inorganic acids M CRM BS EN 13649:2002 NIOSH Detailed in AER body (8L of 323 Methanol E ESTIMATE methanol spilled) Additional Data Requested from Landfill operators * Select a row by double-clicking on the Pollutant Name (Column B) then click the delete button 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: Landfill: Please enter summary data on the quantities of methane flared and / or utilised Mallinckrodt Medical Imaging - Ireland Method Used Designation or Description Facility Total Capacity m3 per hour additional_pollutant_no T (Total) kg/year M/C/E Method Code Total estimated methane generation (as per site model) 0.0 N/A Methane flared (Total Flaring Capacity) Methane utilised in engine/s (Total Utilising Capacity) Net methane emission (as reported in Section A above) 0.0 N/A PRTR# : P0050 Facility Name : Mallinckrodt Medical Imaging - Ireland Filename : P0050_2012.xlsm Return Year : 2012 Page 1 of 1

22 Sheet : Releases to Waters AER Returns Workbook 28/3/ : RELEASES TO WATERS Link to previous years emissions data PRTR# : P0050 Facility Name : Mallinckrodt Medical Imaging - Ireland Filename : P0050_2012.xlsm Return Year : /03/ : 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 RELEASES TO WATERS Please enter all quantities in this section in KGs POLLUTANT QUANTITY Method Used 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/Year * Select a row by double-clicking on the Pollutant Name (Column B) then click the delete button SECTION B : REMAINING PRTR POLLUTANTS RELEASES TO WATERS Please enter all quantities in this section in KGs POLLUTANT QUANTITY Method Used 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/Year * Select a row by double-clicking on the Pollutant Name (Column B) then click the delete button SECTION C : REMAINING POLLUTANT EMISSIONS (as required in your Licence) RELEASES TO WATERS POLLUTANT Please enter all quantities in this section in KGs QUANTITY Method Used 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 * Select a row by double-clicking on the Pollutant Name (Column B) then click the delete button PRTR# : P0050 Facility Name : Mallinckrodt Medical Imaging - Ireland Filename : P0050_2012.xlsm Return Year : 2012 Page 1 of 1

23 Sheet : Releases to Wastewater or Sewer AER Returns Workbook 28/3/ : RELEASES TO WASTEWATER OR SEWER Link to previous years emissions data PRTR# : P0050 Facility Name : Mallinckrodt Medical Imaging - Ireland Filename : P0050_2012.xlsm 28/03/ : SECTION A : PRTR POLLUTANTS OFFSITE TRANSFER OF POLLUTANTS DESTINED FOR WASTE-WATER TREATMENT OR SEWER Please enter all quantities in this section in KGs POLLUTANT METHOD QUANTITY Method Used WWT-01 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/Year 06 - Ammonia (NH3) M CRM G/67 Based on APHA 2012, 22nd Edition, NH3 and bluebook Ammonia in waters Chlorides (as Cl) M CRM G/67 Based on APHA 2012, 22nd Edition, NCL E Total nitrogen M CRM G/93 Based on ENV Total organic carbon (TOC) (as total C or COD/3) C OTH Standard calculation for COD Copper and compounds (as Cu) M CRM G112 Bases on EPA Method * Select a row by double-clicking on the Pollutant Name (Column B) then click the delete button SECTION B : REMAINING POLLUTANT EMISSIONS (as required in your Licence) OFFSITE TRANSFER OF POLLUTANTS DESTINED FOR WASTE-WATER TREATMENT OR SEWER Please enter all quantities in this section in KGs POLLUTANT METHOD QUANTITY Method Used WWT-01 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 238 Ammonia (as N) M CRM G/67 Based on APHA 2012, 22nd Edition, NH3 and bluebook Ammonia in waters BOD M CRM G/04 Based on APHA 2012, 22nd Edition, Method 5210B TCMP Nitrification inhibition COD M CRM G/03 Based on APHA 2012, 22nd Edition, Method 5220D Suspended Solids M CRM G/19 Based on APHA 2012, 22nd Edition, Method 2540D Fats, Oils and Greases M CRM G/32 Based on APHA 2012, 22nd Edition, Method5520B Ortho-phosphate (as P) M CRM 362 Kjeldahl Nitrogen C OTH 327 Nitrate (as N) M CRM * Select a row by double-clicking on the Pollutant Name (Column B) then click the delete button G/67 Based on APHA 2012, 22nd Edition, P.E. Ascorbic Acid Method In house method based on calculation (TN-TON) G/67Based on APHA 2012, 22nd Edition, 4500-N02B colorimetric method Link to previous years emissions data Page 1 of 1

24 Sheet : Releases to Land AER Returns Workbook 28/3/ : RELEASES TO LAND Link to previous years emissions data PRTR# : P0050 Facility Name : Mallinckrodt Medical Imaging - Ireland Filename : P0050_2012.xlsm Return Year : /03/ : SECTION A : PRTR POLLUTANTS RELEASES TO LAND Please enter all quantities in this section in KGs POLLUTANT METHOD QUANTITY Method Used No. Annex II Name M/C/E Method Code Designation or Description Emission Point 1 T (Total) KG/Year A (Accidental) KG/Year * Select a row by double-clicking on the Pollutant Name (Column B) then click the delete button SECTION B : REMAINING POLLUTANT EMISSIONS (as required in your Licence) RELEASES TO LAND Please enter all quantities in this section in KGs POLLUTANT METHOD QUANTITY Method Used Pollutant No. Name M/C/E Method Code Designation or Description Emission Point 1 T (Total) KG/Year A (Accidental) KG/Year * Select a row by double-clicking on the Pollutant Name (Column B) then click the delete button PRTR# : P0050 Facility Name : Mallinckrodt Medical Imaging - Ireland Filename : P0050_2012.xlsm Return Year : 2012 Page 1 of 1

25 T/Year Description 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) Sheet : Treatment Transfers of Waste AER Returns Workbook 28/3/ :38 5. ONSITE TREATMENT & OFFSITE TRANSFERS OF WASTE PRTR# : P0050 Facility Name : Mallinckrodt Medical Imaging - Ireland Filename : P0050_2012.xlsm Return Year : /03/ : Please enter all quantities on this sheet in Tonnes 7 Transfer Destination European Waste Code Hazardous Quantity Quantity (Tonnes per Year) of Waste Method Used Waste Treatment Operation M/C/E Method Used Location of Treatment Name Within the Country No paper and cardboard packaging R3 M Weighed Offsite in Ireland Haz Waste : Name and Licence/Permit No of Next Destination Facility Non Haz Waste: Name and Licence/Permit No of Recover/Disposer Baileys Waste,WFPFG Within the Country No 0.45 plastic packaging R3 M Weighed Offsite in Ireland Baileys Waste,WFPFG Hammond To Other Countries No metallic packaging R4 M Weighed Abroad Lane,WP/173/2008 discarded equipment other than those Within the Country No mentioned in to R3 M Weighed Offsite in Ireland KMK,WCP-OY Within the Country No components removed from discarded equipment other than those mentioned in R3 M Weighed Offsite in Ireland KMK,WCP-OY mixed construction and demolition wastes other than those mentioned in , 17 Within the Country No and R3 M Weighed Offsite in Ireland AES (Drehid),W Within the Country No spent activated carbon D1 M Weighed Offsite in Ireland AES (Drehid),W Within the Country No paper and cardboard R3 M Weighed Offsite in Ireland Shred It,WP98102 Within the Country No biodegradable kitchen and canteen waste R3 M Weighed Offsite in Ireland AES (Drehid),W Within the Country No 0.3 edible oil and fat R3 M Weighed Offsite in Ireland Frylite,CPD461/3A AES (Midlands Waste Disposal Ltd),WCP-OY-08- Within the Country No wood other than that mentioned in R3 M Weighed Offsite in Ireland Within the Country No mixed municipal waste D1 M Weighed Offsite in Ireland AES (Drehid),W other organic solvents, washing liquids and To Other Countries Yes mother liquors D10 M Weighed Abroad Indaver,WL36-2 solid wastes containing dangerous To Other Countries Yes 7.01 substances D10 M Weighed Abroad Indaver,WL36-2 Within the Country Yes 0.9 other engine, gear and lubricating oils R3 M Weighed Offsite in Ireland Indaver,WL36-2 mixtures of wastes from grit chambers and Within the Country Yes 8.0 oil/water separators D6 M Weighed Offsite in Ireland Enva,WL41-1,JFK Road,JFK Ind Est,Bluebell,Dublin 12,Ireland To Other Countries Yes other solvents and solvent mixtures D10 M Weighed Abroad Indaver,WL36-2 Haz Waste : Address of Next Destination Facility Non Haz Waste: Address of Recover/Disposer Ballycoolin Rd,Blanchardstown,Dublin,D ublin 15,Ireland Ballycoolin Rd,Blanchardstown,Dublin,D ublin 15,Ireland Pigeon Hse rd,ringsend 4,Co. Dublin,.,Ireland Cappincur Industrial Estate,Daingean Road,Tullamore,Offaly,Irelan d Cappincur Industrial Estate,Daingean Road,Tullamore,Offaly,Irelan d Killinagh Lower & Killinagh Upper,.,Carbury,County Kildare.,Ireland Killinagh Lower & Killinagh Upper,.,Carbury,County Kildare.,Ireland 53 Parkwest Road,Parkwest Industrial Estate,Dublin,Dublin 12,Ireland Killinagh Lower & Killinagh Upper,.,Carbury,County Kildare.,Ireland Unit S2-S3,Ballymount Industrial Estate,Ballymount Drive,Dublin 12,Ireland Bailey Waste Recycling,.,.,Dublin 11,Ireland Killinagh Lower & Killinagh Upper,.,Carbury,County Kildare.,Ireland Tolka Quay Road,Dublin Port,Dublin,Dublin 1,Ireland Tolka Quay Road,Dublin Port,Dublin,Dublin 1,Ireland Tolka Quay Road,Dublin Port,Dublin,Dublin 1,Ireland JFK Road,JFK Ind Est,Bluebell,Dublin 12,Ireland Tolka Quay Road,Dublin Port,Dublin,Dublin 1,Ireland 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) AVG Hamburg- Germany,IB2234/AVG- GENB-2,Abfall-Verwertungs- Abfall-Verwertungs- Gesellschaft mbh Gesellschaft mbh,borsigstrasse 2,Borsigstrasse 2,Hamburg,22113,Germany,Hamburg,22113,Germany AVG Hamburg- Germany,IB2234/AVG- GENB-2,Abfall-Verwertungs- Abfall-Verwertungs- Gesellschaft mbh Gesellschaft mbh,borsigstrasse 2,Borsigstrasse 2,Hamburg,22113,Germany,Hamburg,22113,Germany Enva,WL41-1,JFK Road,JFK Ind Est,Bluebell,Dublin 12,Ireland Enva,WL41-1,JFK Road,JFK Ind Est,Bluebell,Dublin 12,Ireland JFK Road,JFK Ind Est,Bluebell,Dublin 12,Ireland JFK Road,JFK Ind Est,Bluebell,Dublin 12,Ireland AVG Hamburg- Germany,IB2234/AVG- GENB-2,Abfall-Verwertungs- Abfall-Verwertungs- Gesellschaft mbh Gesellschaft mbh,borsigstrasse 2,Borsigstrasse 2,Hamburg,22113,Germany,Hamburg,22113,Germany PRTR# : P0050 Facility Name : Mallinckrodt Medical Imaging - Ireland Filename : P0050_2012.xlsm Return Year : 2012 Page 1 of 2

26 T/Year Description 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) Sheet : Treatment Transfers of Waste AER Returns Workbook 28/3/ :38 Transfer Destination European Waste Code Hazardous Quantity Quantity (Tonnes per Year) of Waste Method Used Waste Treatment Operation M/C/E Method Used packaging containing residues of or To Other Countries Yes contaminated by dangerous substances R3 M Weighed Abroad packaging containing residues of or To Other Countries Yes contaminated by dangerous substances R4 M Weighed Abroad Location of Treatment Name Haz Waste : Name and Licence/Permit No of Next Destination Facility Non Haz Waste: Name and Licence/Permit No of Recover/Disposer Sita Environmental LTD,W Sita Environmental LTD,W discarded equipment containing hazardous components (16) other than those Within the Country Yes mentioned in to R3 M Weighed Offsite in Ireland KMK,WCP-OY gases in pressure containers (including To Other Countries Yes halons) containing dangerous substances D10 M Weighed Abroad Indaver,WL36-2 laboratory chemicals, consisting of or containing dangerous substances, including To Other Countries Yes mixtures of laboratory chemicals D10 M Weighed Abroad Indaver,WL36-2 discarded inorganic chemicals consisting of To Other Countries Yes or containing dangerous substances D10 M Weighed Abroad Indaver,WL36-2 fluorescent tubes and other mercurycontaining KMK Metals Within the Country Yes waste R4 M Weighed Offsite in Ireland Recycling,W Haz Waste : Address of Next Destination Facility Non Haz Waste: Address of Recover/Disposer Road,Tullamore,Offaly,Irelan d Name and License / Permit No. and Address of Final Recoverer / Disposer (HAZARDOUS WASTE ONLY) Greenogue Industrial JFC Plastics Limited Estate,Rathcoole,Dublin,.,Irel,.,Warcs, U.K.,.,.,United and Kingdom Greenogue Industrial Estate,Rathcoole,Dublin,.,Irel Megisa,., EL Ferroll and Spain,.,.,.,Spain KMK Metals Cappincur Industrial Recycling,W0113- Estate,Daingean 03,Cappincur Industrial Tolka Quay Road,Dublin Port,Dublin,Dublin 1,Ireland Tolka Quay Road,Dublin Port,Dublin,Dublin 1,Ireland Tolka Quay Road,Dublin Port,Dublin,Dublin 1,Ireland Cappincur Industrial Estate,Daingean Road,Tullamore,Offaly,Ireland Estate,Daingean Road,Tullamore,Offaly,Ireland AVG Hamburg- Germany,IB2234/AVG- GENB-2,Abfall-Verwertungs- Gesellschaft mbh,borsigstrasse 2,Hamburg,22113,Germany Actual Address of Final Destination i.e. Final Recovery / Disposal Site (HAZARDOUS WASTE ONLY) Warcs,U.K.,.,.,United Kingdom.,.,.,.,Spain Cappincur Industrial Estate,Daingean Road,Tullamore,Offaly,Ireland Abfall-Verwertungs- Gesellschaft mbh,borsigstrasse 2,Hamburg,22113,Germany AVG Hamburg- Germany,IB2234/AVG- GENB-2,Abfall-Verwertungs- Abfall-Verwertungs- Gesellschaft mbh Gesellschaft mbh,borsigstrasse 2,Borsigstrasse 2,Hamburg,22113,Germany,Hamburg,22113,Germany AVG Hamburg- Germany,IB2234/AVG- GENB-2,Abfall-Verwertungs- Abfall-Verwertungs- Gesellschaft mbh Gesellschaft mbh,borsigstrasse 2,Borsigstrasse 2,Hamburg,22113,Germany,Hamburg,22113,Germany Irish Lamp Recycling,WCP- DC ,Woodstock industrial estate,athy,co. Kildare,.,Ireland Woodstock industrial estate,athy,co. Kildare,.,Ireland Damastown Industrial Covidien Pharmaceuticals Dublin,IPPCL P ,Damastown Industrial Damastown Industrial organic halogenated solvents, washing Covidien Pharmaceuticals Estate,Mulhuddary,Dublin,Du Estate,Mulhuddary,Dublin,Du Estate,Mulhuddary,Dublin,Du Within the Country Yes liquids and mother liquors D8 C Volume Calculation Onsite of generatiodublin,ippcl P blin 15,Ireland blin 15,Ireland blin 15,Ireland Damastown Industrial Covidien Pharmaceuticals Dublin,IPPCL P ,Damastown Industrial Damastown Industrial organic halogenated solvents, washing Covidien Pharmaceuticals Estate,Mulhuddary,Dublin,Du Estate,Mulhuddary,Dublin,Du Estate,Mulhuddary,Dublin,Du Within the Country Yes liquids and mother liquors D9 C Volume Calculation Onsite of generatiodublin,ippcl P blin 15,Ireland blin 15,Ireland blin 15,Ireland Covidien Pharmaceuticals Dublin,IPPCL P ,Damastown Industrial Damastown Industrial Covidien Pharmaceuticals Dublin,IPPCL P ,Damastown Industrial Damastown Industrial other organic solvents, washing liquids and Estate,Mulhuddary,Dublin,Du Estate,Mulhuddary,Dublin,Du Estate,Mulhuddary,Dublin,Du Estate,Mulhuddary,Dublin,Du Within the Country Yes mother liquors R2 C Volume Calculation Onsite of generatioblin 15,Ireland blin 15,Ireland blin 15,Ireland blin 15,Ireland Covidien Pharmaceuticals Dublin,IPPCL P ,Damastown Industrial Damastown Industrial Covidien Pharmaceuticals Dublin,IPPCL P ,Damastown Industrial Damastown Industrial other organic solvents, washing liquids and Estate,Mulhuddary,Dublin,Du Estate,Mulhuddary,Dublin,Du Estate,Mulhuddary,Dublin,Du Estate,Mulhuddary,Dublin,Du Within the Country Yes mother liquors D8 C Volume Calculation Onsite of generatioblin 15,Ireland blin 15,Ireland blin 15,Ireland blin 15,Ireland * Select a row by double-clicking the Description of Waste then click the delete button PRTR# : P0050 Facility Name : Mallinckrodt Medical Imaging - Ireland Filename : P0050_2012.xlsm Return Year : 2012 Page 2 of 2

27 Covidien Pharmaceuticals Dublin AER 2012 APPENDIX 2 IPPC EMISSIONS SUMMARY

28 Covidien Pharmaceuticals Dublin AER 2012 Summary of IPPC Emissions Energy Usage Energy Consumption Sulphur Content Unit Heavy Fuel Oil M 3 /yr Light Fuel Oil 0.05% M 3 /yr Natural Gas M 3 /yr Electricity MWhr Coal Kg/yr Water Unit On-site groundwater use m 3 /yr On-site surface water use m 3 /yr Municipal water use m 3 /yr Process Emissions to Waters Indicate Yes if emissions are to: Freshwater or Sewer Parameter No Unit Yes Max. Licensed Emission per year Volume M 3 /yr Suspended Solids Kg/yr BOD Kg/yr COD Kg/yr Total Dissolved Solids Kg/yr Not Applicable Total Nitrogen Kg/yr Total Phosphorous Kg/yr Toxicity Max. TU 10 <2.2 <2.2 <2.2 Hg Kg/yr Not Applicable Cd Kg/yr Not Applicable Pb Kg/yr Not Applicable Cr Kg/yr Not Applicable As Kg/yr Not Applicable Zn Kg/yr Not Applicable Cu Kg/yr Ni Kg/yr Not Applicable Sulphates Kg/yr Fats,Oils,Grease Kg/yr

29 Covidien Pharmaceuticals Dublin AER 2012 Iodinated Compounds Kg/yr Chlorides Kg/yr Ammonia Kg/yr Nitrates Kg/yr Kjeldahl Nitrogen Kg/yr % Compliance % Number of samples Emissions to air Parameter Unit Max. Licensed Emission per year General Dust Kg/yr * Particulates Kg/yr Sox Kg/yr Nox Kg/yr CO Kg/yr TA Luft Class I Kg/yr * TA Luft Class II Kg/yr * TA Luft Class III (Car & Inorg) Kg/yr * Total Organic (as C) Kg/yr Not Applicable Non-Methane VOC Kg/yr Not Applicable Ammonia Kg/yr Not Applicable Total Heavy Metals Kg/yr Not Applicable Benzene Kg/yr Not Applicable PAHs Kg/yr Not Applicable Dichloromethane Kg/yr Not Applicable PCDDs/PCDFs Kg/yr Not Applicable % Compliance % Number of samples

30 Covidien Pharmaceuticals Dublin AER 2012 APPENDIX 3 EMP FOR (PERFORMANCE FOR 2012 AND PROPOSED AMENDMENTS FOR 2013)

31 EMP for (Performance for 2012 and proposed amendments for 2013) Aspe ct no. 1 & 29 Aspect No. Objective Emissions to air 1 Phase out ozone depleting compounds on site Target 50% 100% 100% Actual 50% 75% 25, 26 & 28 5, 49 & 66 General & Recyclable waste Use of Natural Resources 2 Meet CO 2 emission allowances by: Target 100% 100 % 100 % 100% 100% 3 Review abator by-pass control system. Replace the abator by-pass control system Actual 112% 105% Target 50% 100% Actual 50% 100% 4 To increase the recycling rate to: Target 36% 38% 39% 40% 41% 5 To decrease the civic water usage on-site from 2009 figures based on kgs of Ioversol produced by: Actual 36% 38% Target 1% 2% 3% 4% 5% Actual 6.1% 12% 6 Develop a procurement policy that takes environmental aspects into account Target 100% 100% Actual 40% 23, 43, 47, 51, 57, 60, 61, 64, 67, 80 Use of energy 7 Reduce the Electricity usage on-site based on kgs of Ioversol produced from 2009 figures year on year by: 8 Reduce the gas consumption on site based on kgs of Ioversol produced from 2009 figures year on year by Target 1% 2% 3% 4% 5% Actual 5% 13% Target 1% 2% 3% 4% 5% Actual 2.6% 7% 1

32 EMP for (Performance for 2012 and proposed amendments for 2013) 17 & 18 Management systems 9 Improve internal incident investigation procedure for environmental incidents Target 75% 100% 100% Actual 30% 50% 32 & 33, 27 Emissions to Water - surface water, ground water, sewer 10 Increase the % recovery rate of DMAC to the following rates 11 Increase the % recovery rate of Methanol to the following rates Target 65% 65.5% 66% 67% 67.5% Actual 69.6% 71.5% Target 97% 97.2% 97.3% 97.4% 97.5% Actual 95.4% 95.2% 12 Prevent deterioration of ground water resources through implementation of underground pipeline report requirements Target 25% 50% 100% Actual 10% 60% 13 Conduct a comprehensive study of WWTP operation to improve process control and to decrease variability. Target 50% 100% Actual Please Note: Proposed Amendments to the EMP for 2013 are highlighted in bold and italics for the Agency s information as per Condition of our IPPC license. 2

33 EMP for (Performance for 2012 and proposed amendments for 2013) Environmental Objective Number: 01 Scope: To phase out ozone depleting compounds on site Related to: Ozone Depleting Compounds Legislation Target date: 100% by 31/12/2012 Reviewed: 15/03/2013 Project Summary: The aim of this project is to ensure that the site complies with the expected legislation implementation date of Responsibility: Action Responsible Date List all locations & volumes of Ozone depleting compounds on site Identify suitable replacements Phase in 50% replacements Phase in the remainder 50% replacements of R-22 Determine any other replacement requirements for next phase of legislation Determine any further capital requirements Utilities Engineering Engineering Engineering Engineering Engineering Complete Complete Complete In Progress In Progress Complete Implement project of replacement Engineering 31/05/2013 Investment: Costs to be determined 1

34 EMP for (Performance for 2012 and proposed amendments for 2013) Environmental Objective Number: 02 Scope: Meet GHG CO 2 emissions allowances Related to: IPPCL under emissions to air and Green House Gas permit IE-GHG Target date: 100% for 2012 of the MAPP II allowances. Project Summary: The aim of this objective is ensure that we meet the MAPP II greenhouse gas allowances and reduce our overall CO 2 emissions where possible. Reviewed: 15/03/2013 Responsibility: Action Responsible Date Monthly Monitoring of gas bills Assess impact of new greenhouse gas legislation Determine actions required to site to meet changes and allowances. Implement changes as required Engineering EHS EHS EHS Complete Complete Complete Complete Investment: None 2

35 EMP for (Performance for 2012 and proposed amendments for 2013) Environmental Objective Number: 03 Scope: Review abator by-pass control system. Related to: Aspects 1 & 29 Target date: 100% by 31/12/2012 Reviewed: 15/03/13 Project Summary: The aim of this project is to review the abator bypass control system to reduce the possibility of a breach of the site s IPPC License Responsibility: Action Responsible Date Review and Update SOP for Abator Bypass control Retrain production staff on bypass evaluation tool, bypass reporting and operations control Develop detailed abator start-up and shut down procedure to improve control. Engineering & EHS Engineering & EHS Engineering & EHS Complete Complete Complete Investment: Costs to be determined 3

36 EMP for (Performance for 2012 and proposed amendments for 2013) Environmental Objective Number: 04 Scope: To increase the recycling rate to 41% by 2015 Related to: Aspects 25, 26 & 28 Reviewed: 15/03/2013 Target date: By 31/12/2015 Project Summary: The aim of this project is to increase the recycling rate on-site and thus reduce the amount of waste going to landfill. Responsibility: Action Responsible Date Roll out waste awareness presentation to all employees on-site. Implement viable waste recycling initiatives suggested during waste awareness presentations. Review hazardous waste classifications on site. Introduce Green Office concept EHS EHS (+ relevant departments) EHS Engineering (IS) Complete Complete Complete Complete Assess waste streams across plant through process flow diagrams. Determine opportunities for further recycling Implement waste reductions and recycling opportunities. EHS & Production 31/12/2013 EHS 31/12/2016 Investment: Costs to be determined 4

37 EMP for (Performance for 2012 and proposed amendments for 2013) Environmental Objective Number: 05 Scope: To decrease the civic water usage on-site from 2009 figures based on kgs of Ioversol produced by 5% by 2015 Related to: IPPCL under Energy usage Reviewed: 15/03/2013 Target date: By 31/12/2015 Project Summary: The aim of this project is to reduce the quantity of water consumed per kilo of Ioversol produced thus reducing the overall amount of natural resources consumed by the site. Responsibility: Action Responsible Date Complete a water map for the site Engineering 31/12/2013 Implement the findings from the water map process Engineering 31/12/2014 Investment: Costs to be determined 5

38 EMP for (Performance for 2012 and proposed amendments for 2013) Environmental Objective Number: 06 Scope: Implement a procurement policy that takes environmental aspects into account. Related to: Aspects 5, 49 & 66 Reviewed: 15/03/2013 Target date: 31/12/2012 Project Summary: The aim of this objective is to control the purchasing of hazardous chemicals on site to ensure EHS assessment prior to purchasing of chemicals which may result in using less hazardous chemicals/ ensure those purchased are adequately controlled. Responsibility: Action Responsible Date Conduct a review of systems in place for procurement and determine where environmental aspects need to be considered. EHS & Finance Complete Develop a site policy for procurement. Provide training on the policy site-wide EHS 30/06/2013 EHS 30/09/2013 Investment: N/A 6

39 EMP for (Performance for 2012 and proposed amendments for 2013) Environmental Objective Number: 07 Scope: To reduce the electricity usage on-site based on 2009 figures of kgs of Ioversol produced by 5% by 2015 Related to: IPPCL under Energy usage Reviewed: 15/03/2013 Target date: 31/12/2015 Project Summary: The aim of this project is reduce the amount of electricity used per kg of Ioversol produced thus reducing the overall amount of natural resources consumed by the site. Responsibility: Action Responsible Date Conduct an energy mapping audit for the site Engineering Complete Implement the findings of the energy mapping audit Engineering 31/12/2015 Investment: Costs to be determined 7

40 EMP for (Performance for 2012 and proposed amendments for 2013) Environmental Objective Number: 08 Scope: To reduce the natural gas usage on site based on 2009 figures of kgs of Ioversol produced by 5% by Related to: IPPCL under Energy usage Target date: 31/12/2015 Reviewed: 15/03/2013 Project Summary: The aim of this project is to reduce the quantity of gas consumed to produce Ioversol thus reducing the overall amount of natural resources consumed by the site. Responsibility: Action Responsible Date Install fuel conditioning system Conduct HVAC design review Review further reduction opportunities. This will be completed independently as part of the energy audit. Engineering Engineering Engineering (Included in the Energy audit action) Complete Complete 31/12/2015 Investment: Costs to be determined 8

41 EMP for (Performance for 2012 and proposed amendments for 2013) Environmental Objective Number: 09 Scope: Improve the internal environmental incident investigation procedure Related to: Aspect No 17 & 18 Target date: 100% by 31/12/2012 Reviewed: 15/03/2013 Project Summary: The aim of this project is to streamline and improve the methods of reporting and addressing environmental incidents relating to environmental compliance to ensure awareness of staff in what needs to be reported; to provide means and tools to investigate issues, to root cause if appropriate and determine adequate actions to prevent reoccurrences. Responsibility: Action Responsible Date Review existing incident management process Identify any gaps or room for improvement in plant level investigation relating to IPPC conditions. EHS EHS Complete Complete Evaluate corporate reporting system (Enablon) to tie in with local (Alert Action Report) AAR system Train employees and audit conformance to new incident management process. EHS 30/09/2013 EHS 31/12/2013 Investment: None 9

42 EMP for (Performance for 2012 and proposed amendments for 2013) Environmental Objective Number: 10 Scope: Increase the recovery rate of DMAc (Dimethylacetamide) to the following rates year by year (with result of 67.5 % recovery by 2015): Related to: Aspect No 32 & 33 Target date: By 31/12/2015 Reviewed: 15/03/2013 Project Summary: The aim of this project is increase the amount of DMAc recovered which will reduce the amount of DMAc purchased and the amount being sent to the waste water treatment plant. Responsibility: Action Responsible Date Upgrade heat exchanger separation column reboilers at DMAc recovery plant in order to improve solvent removal Conduct mass balance of system to identify all potential loss points. Identify opportunities for recovery improvement for Engineering Production Complete Complete Recommendations to be implemented Engineering 31/12/2014 Investment: Costs to be determined 10

43 EMP for (Performance for 2012 and proposed amendments for 2013) Environmental Objective Number: 11 Scope: Increase the recovery rate of Methanol to the following rates year by year (with result of 97.5 % recovery by 2015 or <0.4kg/kg Ioversol): Related to: Aspect No 33 Target date: By 31/12/2015 Reviewed: 15/03/2013 Project Summary: The aim of this project is increase the amount of methanol recovered which will reduce the amount of methanol purchased and the amount being sent to the waste water treatment plant. Responsibility: Action Responsible Date Change the packing in the MeOH column to increase recovery efficiency. Full review of MeOH recovery process to identify further opportunities for recovery improvement. Recommendations from process review to be implemented. Engineering 31/12/2013 Engineering 31/12/2013 Engineering 31/12/2014 Investment: Costs to be determined 11

44 EMP for (Performance for 2012 and proposed amendments for 2013) Environmental Objective Number: 12 Scope: To prevent deterioration of ground water resources Related to: Aspect No 27 Reviewed: 15/03/2013 Target date: 100% by 31/12/2012 Project Summary: The aim of this project is ensure all underground pipework is adequately maintained to ensure there are no impacts to groundwater Responsibility: Action Responsible Date Review underground pipeline reports for surface and foul water Based on report reviews, plan work with Engineering and Utilities EHS EHS & Engineering Complete Complete Implement checks and repairs as determined by report Utilities & Engineering 31/07/2013 Investment: 1,000,000 approximately. 12

45 EMP for (Performance for 2012 and proposed amendments for 2013) Environmental Objective Number: 13 Scope: Conduct a comprehensive study of WWTP operation to improve process control and to decrease variability. Related to: Aspect No 27 Reviewed: 28/03/2013 Target date: 100% by 31/12/2014 Project Summary: The aim of this project is to improve the efficiency of the WWTP and to decrease variability within the process. Responsibility: Action Responsible Date Work in conjunction with NUIG to commission study on the WWTP operation to improve process control and to decrease variability. Submit a report on the on the findings for the study to the facility. EHS 31/12/2013 EHS 31/12/2014 Implement findings from the study. Engineering EHS 31/12/2015 Investment: Costs to be determined 13

46 APPENDIX 4 POLLUTION EMISSION REGISTER REPORT 2012

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48 1 INTRODUCTION This is the Pollution Emission Register of Mallinckrodt Medical Imaging Ireland (trading as Covidien Pharmaceuticals Dublin) as per Condition 2.4 of the Integrated Pollution Control Licence No. P The substances for the 2012 Pollution Emission Register are: Total Nitrogen (CAS No ) 2-Chloroethanol (CAS No ) Page 1 of 6

49 2 MASS BALANCES 2.1 TOTAL NITROGEN Process Description N,N,Dimethylacetamide (DMAc) is charged to the process from a bulk tank in the tank farm. The DMAc molecule is ca. 16.1% nitrogen. The second source of nitrogen is the raw material for the process (MP-104). This comprises 6.0% nitrogen. The product, Ioversol, comprises 5.2% nitrogen. The nitrogen remaining in the waste water treatment effluent discharged to Sewer is measured as part of the IPPC license requirements. The emission to air, comprising largely nitrogen as a result of nitrification / denitrification in the waste water treatment plant is estimated by difference. We maintain a high proportion of nitrifying bacteria in the waste water treatment plant. We monitor the ammonia levels closely as this parameter is a good indicator of the operation of the nitrification / denitrification process Final Mass Balance A final mass balance for Total Nitrogen is shown below. This is based on the actual usage data for year Air 4 MP Process WWT DMAc 2 Sewer 5 Product 3 Stream No Description. MP-104 In (as N) DMAc in (as N) Product Out (as N) Emit to Air (as N) Emit to Sewer (as N) T h Kgs p.a % 42.5% 40.0% 17.5% The quantities in Streams 1 and 2 are based on actual purchases. Stream 3 is based on measurements. Stream 5 is based on measurements. Stream 4 is estimated by difference. Page 2 of 6

50 The emissions to air are predominately pure nitrogen from the nitrification / denitrification processes in waste water treatment.. We have estimated from previous PER work on DMAc that only 6.7 kgs of this total quantity relates to fugitive losses of pure DMAc Fugitive Emissions Estimates from previous mass balances for DMAc indicated that the total fugitive emissions associated with this material are ca. 42 kg/yr comprising ca, 6.7 kg of N. This represents ca % of the total nitrogen input. This shows the negligible extent of fugitive emissions of DMAc CHLOROETHANOL (CE) Process Description 2-Chloroethanol is charged to the process from 200 litre drums in a dedicated drum charging area. A portion of the Chloroethanol is reacted as part of the manufacturing process. The remainder is chemically destroyed by treatment with sodium hydroxide to form ethylene glycol. The waste water is treated in the on site waste water treatment facilities. The vents from the vessels containing Chloroethanol are directed to the catalytic abator. The destruction routes for CE have been verified by measurements at the Abator Outlet, the CE destruction vessel and the outlet to the sewer. Additional measurements of these locations made during 1999 have been used to verify the balances in the above table Final Mass Balance A final mass balance for 2-ChloroEthanol is shown below. This is based on the actual usage data for year 2012 Page 3 of 6

51 4a 4b 4c 4e 4f 4d 4 1 1a Process facilities 1b CE Destruction 2 Waste Water Treatment 3 Discharge to sewer 2-Chloroethanol 5 Stream No. 1 1a 1b 2 3 4a Description CE in CE Reacted CE Destroyed Degraded in WWT Emit to Sewer Drum Charge Losses Kgs p.a ,000 8 % Stream No. 4b 4c 4d 4e 4f 5 Description ETO Abator Outlet Building Vent Losses Air Strip Loss HS Waste Tank Other Fugitive To offsite incineration Losses Kgs p.a % The quantity in Streams 1 is based on the number of batches manufactured. Streams 2, 3, 4a, 4b, 4c, 4d are based on past measurements. Stream 1a is based on stoichiometry. Stream 4e is based on an estimate based on a measurement of TOC. Stream 1b is estimated by difference. No Chloroethanol is sent for incineration offsite. The above table shows that the mass balance is close to less than 0.01%. This is well within the 15% allowance for existing plant (and the 5% allowance for new plant) under EU Directive 1999/13/EC Fugitive Emissions The measurements for the mass balance indicate that the extent of fugitive emissions (streams 4a, 4c, 4d, 4e) amount to less than 0.5 % of the solvent input. These values show the negligible extent of fugitive emissions of 2-Chloroethanol in the process. Page 4 of 6

52 3 FUTURE DEVELOPMENTS 3.1 TOTAL NITROGEN As the total nitrogen discharge to Sewer is 6% of the licence limit we consider that the material is under excellent control with no negative impact arising. We believe that no further reduction measures are warranted at this time. Covidien Pharmaceuticals Dublin will endeavour to minimise the amount of nitrogen being discharged to sewer by ensuring that the treatment facilities operate to optimise the degradation of nitrogen containing wastes. The objective will be to remain within our licence limits on all parameters at all times CHLOROETHANOL (CE) The overall reduction achieved since the CE usage optimisation commenced in 2002 is in excess of 10%. No further optimisation is planned at this time due to process chemistry constraints. Covidien Pharmaceuticals Dublin will endeavour to minimise the amount of all solvents being directed to waste water treatment and will ensure that the treatment facilities operate to optimise the degradation of these wastes. The objective will be to remain within our licence limits on all parameters at all times. Page 5 of 6

53 4 CONCLUSIONS The treatment of nitrogen containing compounds is well controlled and the destruction routes are well documented and environmentally friendly with no negative environmental impact. The use of 2- Chloroethanol is well controlled and the destruction routes are well documented and very environmentally friendly with no negative environmental impact. Page 6 of 6

54 Appendix A Pollution Emission Register Form

55 Pollution Emissions Register PER does not apply to your license, please tick here Input Outputs Pollutant Name CAS No. Input Gross Usage Emissions to air MO M Emissions to waters MOM Wast e MOM Product MOM Recovery Treated Unaccounted 2-Chloroethanol , , C 0 M M M Total Nitrogen E M 0 C M 0 0 0

56 Appendix 5 Ground Water Monitoring Report AER 2012 REV 0

57 BIENNIAL IPPC COMPLIANCE MONITORING OF GROUNDWATER AT MALLINCKRODT MEDICAL IMAGING IRELAND, DAMASTOWN, MULHUDDART, DUBLIN 15. IN ACCORDANCE WITH IPPC LICENCE P For the Attention of: Mr. Gerard Shannon Environmental Officer Covidien Pharmaceuticals Damastown Industrial Estate, Mulhuddart, Dublin 15 Prepared by: Mr. Eamonn Lee Environmental Scientist Reviewed by: Mr. Ronan Connolly Environmental Scientist Report No: ECS4212 Monitoring Date: 30 th March 2012 Report Date: May 2012 This report shall not be reproduced except in full, without the approval of ANUA Environmental. All queries concerning the report or its contents should be forwarded to the Monitoring Team leader.

58 Report No. ECS4212 EXECUTIVE SUMMARY The Mallinckrodt Medical Imaging Ireland site was visited by an ANUA Environmental Scientists on the 30 th of March 2012 for the purpose of conducting the company s biennial groundwater monitoring programme for 2012, in accordance with IPPC Licence Reg. No. P During the monitoring event, samples were obtained from six groundwater monitoring wells, namely; MW1, MW2, MW3, MW4, MW5 and MW6. The results of the groundwater are compared with the Groundwater Threshold Values (GTV) as set out in the Report European Communities Environmental Objectives (Groundwater) Regulations 2010 (S.I. N o. 9 of 2010) and the EPA Interim Guideline Values (IGV) as set out in the Interim Report Towards Setting Guideline Values for the Protection of Groundwater in Ireland. Any parameters which exceed their respective guideline values are compared to the previous monitoring event in August 2010 (See BNM Report Ref. ECS3724). Exceedences of their respective GTV s / IGV s have occurred for the following parameters: Inorganics Metals -Calcium (MW2,MW3,MW4,MW5,MW5A,MW6), -Sulphate (MW2,MW3,MW5), -Nickel (MW3) - Iron (MW2,MW4,MW5,MW5A,MW6), - Manganese (All wells), - Cadmium (MW2), - Aluminium (MW2,MW4,MW5A,MW6), - Barium (MW2,MW3,MW4,MW6), The result of the monitoring event show general groundwater improvement compared to the 2010 monitoring event. There has been a significant drop on the concentration of many heavy metals, with less exceedances noted. VOC s remain undetected for this monitoring event. TPH parameters were detected at location MW-4. The report from the laboratory, stated that this was due to the sample being heavily contaminated with sediment and solids. TPH parameters were not detected above their respective laboratory limits at the remaining boreholes sampled. Respectively Submitted, Mr. Eamonn Lee Environmental Scientist Mr. Ronan Connolly Environmental Scientist Mallinckrodt Medical Imaging Ireland Ltd. Page 2 April 2012

59 Report No. ECS4212 CONTENTS 1.0 INTRODUCTION 2.0 METHODOLOGY 2.1 Borehole Locations 2.2 Representative Groundwater Sampling 2.3 Analysis 3.0 ENVIRONMENTAL SETTING 3.1 Surrounding Land Use 3.2 Geology and Hydrology 4.0 COMMITMENT TO QUALITY 4.1 INAB Accreditation 4.2 Interlaboratory Proficiency Schemes 4.3 Control Chain of Custody 5.0 RESULTS 6.0 DISCUSSION APPENDICES APPENDIX 1: Drawing Illustrating Groundwater Flow Direction and Monitoring Locations. APPENDIX 2: USEPA Compound Listing Mallinckrodt Medical Imaging Ireland Ltd. Page 3 April 2012

60 Report No. ECS INTRODUCTION In accordance with the company s IPPC Licence, Register No. P [Schedule 4 (ii)], Mallinckrodt Medical Imaging Ireland is required to conduct a biennial monitoring programme of the groundwater monitoring boreholes at the site. ANUA Environmental was commissioned to perform the sampling and analysis for this monitoring event. The site was subsequently visited by an ANUA Environmental Scientists on the 30 th of March 2012 to carry out a groundwater monitoring event. Groundwater samples were returned to the laboratory for analysis. This report outlines the accurate sampling and analytical methodologies adopted, including an interpretation of the results obtained. The Mallinckrodt Medical Imaging Ireland site is located in Damastown, Mulhuddart, Co. Dublin, as shown in Figure 1.1 below. Figure 1.1 Site Location Map Mallinckrodt Medical Imaging Ireland Ltd. Page 4 April 2012