ATTACHMENT - Environmental Protection Agency, Ireland

1 Co ns en to f c Fo op r i yr ns ig pe ht ct ow ion ne pu r r rp eq os ui es C. re o d nl fo y. ra ny ot he ru se . ATTACHMENT . EPA Export 25-07-2013:16:08:26. ATTACHMENT C. IPPC Application 750. ATTACHMENT C - SITE management AND CONTROL. - management of the Activity Environmental management of the facility is controlled by the Site management Team with day to day responsibilities lying with the Environment Health and Safety (EHS). Department. The EHS Department in pfizer , Dublin comprises of four full - time colleagues in the following job categories: EHS Manager, EHS Administrator, Health and Safety Officer, and Environmental Officer.

2 The Department also comprises of an Occupational Physician, who is on site one morning a week and an Occupational Health Nurse, who is on site three days a week. The management of pfizer Ireland Pharmaceuticals, Dublin is committed to good Environmental practice. EHS Meetings with the management Team take place on a monthly basis to discuss the progress and performance of the EHS Department, general EHS issues, compliance issues and the allocation of resources and responsibilities for completion of EHS objectives and targets.. se ru he A chart of the Site management Team and the EHS Team is included as ATTACHMENT ot ny fo y.

3 And respectively. d nl ra re o ui es eq os The structure of the management system can be described as comprising of seven key r r rp ne pu elements aimed at a continuous improvement strategy. A brief explanation of each of the ow ion ht ct seven elements within the management system is given below. ig pe yr ns op r i f c Fo Organisation & Personnel This element defines the following requirements within the EHS management system to en The definition and documentation of roles and responsibilities of all employees ns l Co l The training awarenessand competence of all employees and contractors on site l Proceduresto be implemented to respond to internal and external queries relating to the EMS.

4 Identify Hazard This includes the systematic identification of hazards within the workplace and the implementation of proper controls to minimise risks and maintain a safe working environment for all employees. Operational Control This element includes the requirement for documented procedures and work instructions for all activities within the facility. This includes operating criteria and the control of procurement and contracted activities. In pfizer Dublin, every procedure written on site requires EH&S approval before it can be implemented. This includes the identification of potential incidents or Environmental effects which could result from any planned process modifications or installations.

5 EPA Export 25-07-2013:16:08:26. ATTACHMENT C. IPPC Application 750. This is controlled internally by the requirement of EH&S sign off both at local management level and at corporate level if required for all Capital PurchaseAcquisitions (CPA's). Day to day process change requires the generation of a Change Notification Request form (CNR) all of which EHS approval prior to implementation. Planning for Emergencies This involves the identification of potential accidents/incidents and the implementation of prevention and mitigation measures in the form of a site Emergency Plan and associated periodical testing of these procedures and required training is included in this element.

6 Monitoring Performance The implementation of procedures to evaluate the performance of the facility against the EHS objectives and targets as well as relevant regulatory and legislative requirements is an integral part of achieving continuous improvement within the EMS. The data obtained is combined with the data resulting from monthly departmental self-assessments,annual EHS self-assessment and corporate audits/objectives to compile the EHS Plan for the following year.. se ru he Audit & Review ot ny fo y. This examines the appraisal of all elements of the management system in order to assess d nl ra re o ui es its overall successin achieving compliance with the EMS, management commitment, and eq os r r rp improvement of Environmental performance, compliance to regulatory requirements and ne pu ow ion employee awarenessand training.

7 Ht ct ig pe yr ns op r i The company operates an Environmental management system that is committed to f c Fo continuous improvement. Continuous improvement in EHS performance is encouraged to through periodic and systematic EHS management systems reviews. The management en ns system review evaluates approachesused to manage EHS issues and programs ( the Co EHS management system ) to determine if they are working effectively. The management system is reviewed annually to ensureit is meeting required regulatory expectations. Part of the management system review involves developing an Environmental management programme (EMP) on an annual basis.

8 This EMP addressesobjectives and targets for specific continuous improvement and conservation projects on site. Each of the Environmental management considerations including the site energy and water conservation policies, release reduction Ii-om the site, waste minimisation programmes, BAT, and best Environmental performance are taken into account when preparing the annual EMP, and objectives and targets. The most recent site EMP is included in ATTACHMENT In line with pfizer corporate guidelines, the EHS programme addressesalso addresses community outreach, which includes a procedure for documenting and responding to complaints received.

9 A copy of SOP - Internal-External Environmental Complaint Procedure is included in Appendix 1 of this report. EPA Export 25-07-2013:16:08:26. ATTACHMENT C. IPPC Application 750. Section - Calibration and Maintenance Calibration and monitoring is controlled by the site PEMAC system - (preventative maintenance system ). Critical plant equipment including equipment involved in Environmental controls on site, is included under the remit of this system . PEMAC work orders are detailed on the PEMAC system , with specified timelines when scheduled checks must be completed by designated maintenance personnel.

10 The SOP on the PEMAC system in included in Appendix 1 of this report. The following Environmental checks are included in the PEMAC system . l Integrity of the activated carbon filter (Used for abating emissions from emission point A2-1.). This integrity check is based on the monthly monitoring of pre-and post filter emissions from this monitoring point. The EHS Department schedulethe replacement of these carbon filters by an external contractor - Camfil Farr Ltd. Camtil hold replacement filters on behalf of pfizer Ireland Pharmaceuticals. l Integrity of the HEPA filter in the dispensary booth.