attachment c.1 abbott ireland organisational chart ... · 5.4.1 the register of environmental...

Abbott Cootehill - EPA IPPC Licence Review Application AWN Consulting Limited _________________________________________________________________________________________________________________________________________________

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C.1 -

Attachment C.1

Abbott Ireland Organisational Chart – Abbott Cooteh ill

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Abbott Ireland Organisation Chart 2011

John Kilcoyne Plant

Manager

Christina Farnan

QA Manager

Gus MacEntire Technical Manager

Fred Finch Financial Controller

Brendan Lynch

Engineering Manager

Sharon Conlon

HR Manager

Tom Connaughton Materials Manager

John Rohan EHS &

Operations Manager

Alan MaGovern

Manufacturing Manager

Petrina Ashford

EHS Coordinator

Process Engineering Manager

Utilities Engineer

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Abbott Cootehill - EPA IPPC Licence Review Application AWN Consulting Limited _____________________________________________________________________________________________________

_____________________________________________________________________________________________________

C.1.2 - Page 1

Attachment C.1.2

Quality Management & Food Safety Systems

As outlined in the Abbott Quality and Food Safety Manual, Quality & Food Safety to Abbott is a philosophy, an attitude, and a state of mind of how well we do our jobs and how much we care. In regard to Abbott Cootehill products, it can be defined as a totality of features and characteristics that bear on the ability to satisfy fitness for use, safety and efficacy. Thus, it is a measure of performance in terms of meeting customer needs and regulatory expectations.

Abbott Nutritional Cootehill endeavours to:

• Build quality into products, processes and services; and • Incorporate continuous improvement into all aspects of the business.

The quality policy for the facility is shown below:

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C.1.2 - Page 2

Abbott Cootehill Quality & Food Safety Policy Statement

Abbott Nutritional Supply Chain is dedicated to improving health care by providing high quality,

safe, effective products and ensuring compliance. This is achieved through a commitment to quality

and the continuing effectiveness of the quality management system to meet customer and

regulatory requirements.

This is achieved by Abbott Cootehill as follows:

• Compliance to world-class systems i.e. ISO 9001:2008, ISO 22000, PAS220, ISO 14001, Abbott Corporate and Division Policies and local procedures.

• Effective Management Review Process. • Meeting all applicable legislative, regulatory and customer Food Safety

requirements through an effective Food Safety Management Programme. • Continuous Improvement Philosophy.

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C.1.2 - Page 3

Quality & Food Safety Manual There is a Quality and Food Safety Manual for the facility, which outlines the process-based approach to both Quality Management and Food Safety Management and meets the requirements of ISO9001, ISO2200 and PAS220. The process based approach is designed to to facilitate consistency with the standards, allow ease of implementation and compliance assessment, as well as facilitation of more ongoing control and effectiveness of detailed processes within the organisation. The Quality and Food Safety Systems Manual details organizational structure, defined roles and responsibilities and an outline of the documentation structure used to support the Quality and Food Safety System. The document serves as evidence to all customers, suppliers and employees that Abbott Cootehill is committed to providing safe and effective products and services.The manual includes, amongst other items control systems, monitoring and measurement, validation, auditing and corrective action procedures. The QMS certification is included as part of this attachment. The Quality System Manual and related procedures is available on site and can be provided to the EPA as required.

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C.2 - Page 1

Attachment C.2.1

ISO14001 EMS Certification & Standard Operating Procedures

EN16001 Energy Management Certification

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Certificate IE96/7727

The management system of

Abbott IrelandDrumore West,

Cootehill, Co. Cavan, Ireland

has been assessed and certified as meeting the requirements of

ISO 14001 :2004For the following activities

The manufacture of milk based infant formulae.

This certificate is valid from 26 July 2008 until 26 July 2011 andremains valid subject to satisfactory surveillance audits.

Re certification audit due before 26 July 2011Issue 5. Certified since 26 July 1996

Authorised by

~UKAS

ENVIRONMENTALMANAGEMENT

005

J----SGS United Kingdom l.td Systems & Services Certification

Rossmore Business Park Ellesmere Port Cheshire CH653EN UKt -+44 (0)151 350-6666 f -+44 (0)151 350-6600 wwwcsgs.com

SGS EMS 04 0308

Page 1 of 1

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1.0 INTRODUCTION

This SOP outlines the procedure to control Environmental, Health & Safety & Energy documentation at the Abbott Cootehill site.

2.0 SCOPE

This covers all documents relating to Environmental, Health & Safety & Energy on site. Documents such as :

(a) Environmental Manual (b) SOP and Inspection Sheets (c) Register of Aspects (d) Register of Legislation (e) EHS Management Programme

(f) Emergency Response Plan (g) Energy Manual

3.0 DEFINITIONS:

EHSMS = Environmental, Health & Safety Management System including Energy.

4.0 RESPONSIBILITY

It is the responsibility of the Management Representative to ensure all EHSMS documentation is up to date, legible, accurate and controlled as per agreed arrangements. EHSMS Training Records for the relevant departments are maintained by the H.R. Department.

5.0 PROCEDURE 5.1 Deviations and Changes

Any employee may request a deviation change to plant documentation. Deviations require at least 2 approval signatures, one of which must be the EHS Management Representative for the plant and another from Senior Management.

5.2 EHS Manual(s)

5.2.1 Environmental Health & Safety Manual is controlled through QDMS, as is all other EHS SOP’s. The Energy Manual is also controlled through QDMS.

5.2.2 Relevant external documents pertaining to EHSMS are

controlled through the EHS Network Drive.

Document ID: Document Type: Title:

Version Control Site:

This information is confidential to Abbott. The user is responsible for using the appropriate version of this document.

Abbott - Abbott Nutrition

EHS003 Effective Date: 17-Nov-2008Standard Operating Procedure Approved Date: 17-Nov-2008

Control of Documentation Pertaining to EHSMS

6.0, EffectiveAN - Cootehill IE (QA) Page 1 of 3

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5.4 Register of Aspects

5.4.1 The Register of Environmental Aspects is controlled by revision number and revision date. The Master copy is held by the Management Representative. A complete revision of the register takes place on an annual basis or as required. Amendments to the register and are tracked via Environmental Team minutes of the Review Meeting(s).

5.4.2 The register of Energy Projects is controlled by the Energy Champion and stored on the EHS drive.

5.5 Register of Regulations

5.5.1 The Environmental Register of Regulations is controlled by revision number, date and revision history. The entire Register is reviewed on an annual basis as per EHS 012.

5.5.2 The Energy Register of Legislation is controlled by revision no. and stored on EHS Drive.

5.6 Management Programme

5.6.1 The Management Programme and Objectives and Targets are reviewed regularly at Environmental Team Meetings. Amendments to the Management Programme are controlled via revision number and revision sheet.

5.6.2 Energy objectives and targets will also be reviewed at Environmental Team Meetings.

5.7 ERP (Emergency Response Plan)

5.7.1 The Emergency Response Plan is reviewed at a minimum once per year. The plan is version controlled.

6.0 RECORDS

6.1 Environmental Records generated as part of the EMS programme shall be legible, identifiable and traceable to the relevant activity. Records demonstrate conformance to the requirements of ISO14001. Retention requirements for records is specified in Environmental Manual.

7.0 REFERENCES 7.1 SOP QA130 Writing and Control of SOPs








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7.2 SOP EHS008 Identification and Evaluation of Environmental Aspects

7.3 SOP EHS012 Environmental Legislation and Regulatory Requirements 7.4 SOP EHS007 Setting & Monitoring of E.H.S. Objectives & Targets

7.5 EHS Drive

8.0 REASON FOR REVISION

8.1 As per CR 520.








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1.0 PURPOSE

The internal audit procedure is used to verify that EHS &E management activities comply with legislation and planned arrangements and to determine the effectiveness of the EHS & E Management System.

2.0 SCOPE

This procedure covers all elements of the EHS & E Management System as referenced in the EHS Management Manual/ Energy Manual and in the audit schedule. It provides a systematic review of the Energy Management System

3.0 RESPONSIBILITY The management representative is responsible for the implementation of this procedure. 4.0 PROCEDURE

4.1 Formal internal audits shall be conducted in order to assess the compliance with the Management System, ISO14001 and IS393 requirements, and relevant legislation. Such audits shall be carried out in accordance with an audit schedule. The EHS co-ordinator draws up audit schedules annually specifying the areas to be audited (Standard Management System requirements) and audit dates and the auditor.

4.2 In the course of the audit, departmental managers or other appointees

shall accompany the auditor and provide any information/records requested.

4.3 Functions shall be audited with a frequency of not less than one

year, but the frequency of audits must be increased when the need to do so is realised. This shall be influenced by such considerations as:

• The time lapsed since the last audit and any problems that might have arisen within the workings of the functions. • The results of previous audits. • Recent or impending changes to the procedures. • The environmental significance of the activity concerned. • The health & safety risk of the particular operation. • The importance of the process.

4.4 Audits shall be conducted by trained / competent auditors (who shall be independent of the activity involved). The auditor should preferably complete an internal auditing training course. The situation may arise that an auditor is involved in auditing his functional area. However, in





EHS006 Effective By Date:04-Jul-2009Standard Operating Procedure Approved Date: 04-Jun-2009

Internal Environmental audit Procedure (Ref. ISO 14001)


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such a situation that auditor should allow another auditor to complete the audit of his/her functional area if possible.

4.5 The auditor shall first verify that previous corrective actions have been effectively discharged.

4.6 They must confirm that the EHS & E Management System is working as planned i.e. investigate progress towards achieving objectives, assess level of awareness throughout the plant, establish compliance with procedures and programmes etc.

4.7 The auditor(s) carry out the audit with the assistance of the audit

checklists. A summary of each audit shall be recorded on the Audit Report Sheet. Any non-conformances detected during the audit should be recorded by the auditor with the evidence to confirm the finding.

4.8 All non-conformances that are identified are documented in the ENC

form (ref. to SOP EHS031). These corrective actions shall be crossed referenced internally with the Audit Report. If the audits reveal non-conformances then these will be added to the non-conformance spreadsheet managed by the EHS Department.

4.9 Follow up preventive audits / inspections may be conducted where

necessary to verify the implementation and effectiveness of corrective / preventive action. Audit results will be on the agenda at Management Review meetings and communicated to senior management.

5.0 RECORDS Copies of the ENC form and audit checklist are retained by the Management Representative for a minimum period of five years. 6.0 DOCUMENTS REFERENCED SOP EHS031 EHS Non Conformance Procedure 7.0 REASON FOR REVISION

May 2009 – Per CR 264





EHS006 Effective By Date:04-Jul-2009Standard Operating Procedure Approved Date: 04-Jun-2009

Internal Environmental audit Procedure (Ref. ISO 14001)


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Subject: External Environmental Noise & Occupational Noise Monitoring 1.0 PURPOSE

The purpose of this procedure is to quantify environmental and industrial hygiene noise and ascribe a scale of measurement to it, allowing an assessment to be made as to whether intervention is required to prevent, control or minimise noise.

2.0 BACKGROUND Industrial Hygiene Employees

2.1 Noise can have a major hearing loss to employees that are exposed to it over long periods of time. Noise level above 85 dB employees must have the option of wearing hearing protection supplied by their employer and the company must insist on employees that they wear hearing protection above 90 dB. The following areas of the plant are above 85 dB and signs are erected to point out same.

♦ Boilerhouse ♦ Dryer 1 + 2 ♦ Wet Processing Area ♦ Evaporator 1 + 2 ♦ Packing Room 1 + 2 ♦ Engineering workshop equipment

2.2 The generation of excessive noise in the community can have

undesirable effects on the population. Noise sensitivity is usually greater at nighttime than it is during the day by about 10dB (A). Ideally if total noise level from all sources is taken into account, the noise level at sensitive locations should be kept below a value of 55dB (A) by daytime. At night to avoid disturbance, the noise at noise sensitive locations should not exceed a value of 45dB(A).

The following times differentiate day from night;

DAY: 08.00hrs to 22.00hrs NIGHT: 22.00hrs to 08.00hrs





EHS011 Effective By Date:13-Aug-2009Standard Operating Procedure Approved Date: 14-Jul-2009

External Environmental Noise & Occupational Noise Monitoring


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3.0 RESPONSIBILITY

It is the responsibility of the Operations Manager to ensure that environmental noise monitoring is conduced on an annual basis or at intervals dictated by a process change or equipment introduction.

4.0 DEFINITIONS / ABBREVIATIONS

Noise: Unwanted sound. Any sound which has the potential to cause disturbance, discomfort or psychological stress to a subject exposed to it, or any sound which has the potential to cause actual physiological harm to a subject exposed to it or physical damage to any structure exposed to it, is known as noise.

Noise Sensitive Locations: Any dwelling house, hotel or hostel, health building, educational establishment, place of worship or entertainment, or any other facility or area of high amenity which for its proper enjoyment requires the absence of noise at nuisance levels.

Decibel (dB): The unit of sound pressure level, calculated as a logarithm of the intensity of sound. 0 dB is the threshold of hearing, 120 dB is the threshold of pain. A change of 1 dB is detectable only under laboratory conditions. A change of 3 dB corresponds approximately to halving or doubling the loudness of sound.

dB(A): Decibels measured on a sound level meter incorporating a frequency weighting (A weighting) which differentiates between sound (pitch) of different frequency (pitch) in a similar way to the human ear. Measurement in dB(A) broadly agree with peoples assessment of loudness. The background noise level in a sitting room may be about 40 dB, heavy road traffic at 60 M about dB(A).

5.0 PROCEDURE

5.1 In an activity where new plant is being purchased or existing plant is being replaced, the first step in the control of noise should be the selection of low noise emission equipment. Regard to The European Communities (Protection of Worker) (Exposure to Noise) Regulations 1990 (S.I. No. 157 of 1990) and the European Communities (Construction Plant and Equipment) (Permissible Noise Levels) Regulations 1988 (S.I. No. 320 of 1988) should be taken.








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5.2 Condition 3.4 of the IPPC License states: noise from the activity shall not give rise to sound pressure levels (Leq. 15min) measured at noise sensitive locations which exceed the limit value(s) by greater than 2dB(A). Condition 8 of the IPPC License states: Activities on-site shall not give rise to noise levels off-site, at noise sensitive locations, which exceed the following sound pressure limits (Leq, 15 min) subject to Condition 3 of this licence:

Daytime: 55 dB(A), Night-time: 45 dB(A).

Legislation governing noise as a nuisance is contained in two legal instruments, namely:

a) EPA Act 1992 Sections 107 and 108 b) EPA Act 1992 (Noise) Regulations 1994 (S.I. No. 179 of 1994)

5.3 Noise monitoring locations must comply with Condition 8 of the IPPC Licence and schedule 4(iv) noise monitoring.

5.4 The annual noise survey should be carried out a competent

contractor in compliance with Schedule 4 (iv) of the site’s IPPC License. The noise survey is undertaken to assess the site compliance with Condition 8.3 and 8.4 of the IPPC licence. The scope of the survey is to measure the noise levels at the site’s nearest noise sensitive locations (NSLs) (five in total) during the day and night time.

5.5 The noise monitoring shall be conducted in accordance with the

following guidance: • EPA Environmental Noise Survey Guidance Document (2003) • International Standard ISO 1996-1:2003 - Acoustics – Description and Measurement of Environmental Noise (2003)

5.6 Noise monitoring has been strategically selected inside the plant to monitor employees exposed to noise. Noise levels are communicated to people in the Briefing System to employees, on notice boards, signage at entrances to areas and in risk assessments.

5.7 Noise measurements, which may be affected by weather

conditions, which introduce unacceptable errors into the data, should be identified and eliminated where possible. Such








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conditions include rainfall, and wind-speeds in excess of 7 m/sec. Care should be taken to avoid measurements being made so close to objects as to give rise to wind derived noises, e.g. trees, cables, buildings, etc. For complaint investigation or where variation in noise levels due to wind propagation are a factor, longer monitoring periods than those specified maybe required.

5.8 A discussion report should be compiled of the results attained

indicating environmental performance and corrective action if applicable or possible. Follow-up monitoring should indicate the effectiveness of the corrective action. Results should be paraphrased and included in updates to the Register of Aspects.

6.0 RECORDS

6.1 Annual Noise Monitoring records shall be maintained by the Operation Support Manager. Occupational plant noise monitoring records shall be maintained by the Health & Safety Manager.

6.2 Employees that are exposed to high noise levels will have hearing

checks on a regular basis per legal requirements. The company medical office gets these reports on behalf of the company.

7.0 REASON FOR REVISION 7.1 July 2009 – Per CR 312








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1.0 Introduction:

This SOP details the investigation and reporting procedures to be followed in the event of environmental incident/release together with the preventative action taken to prevent reoccurrence of incident/release.

2.0 Responsibility:

The responsibility to ensure that each environmental incident/release is investigated and reported lies with the Management Representative. In his absence, the responsibility lies with the relevant Departmental Manager where the incident/release occurred.

3.0 Definition/Abbreviations:

'Incident' means any undesired event that, under slightly different circumstances, could have resulted in environmental loss; referred to in health & safety terms as a near miss.

'Release' should be referred to as any spilling, leaking, pumping, pouring, emitting, emptying, discharging or escaping into the environment of any matter, which has the potential to result in environmental loss. Release also includes discharges outside of the effluent licence parameter limits, which can cause harm to the environment.

4.0 Investigation Procedure:

4.1 Each environmental incident/release is to be investigated immediately after occurrence. 4.2 If warranted, wear the appropriate protective clothing before entering the area of incident/release.

4.3 The incident/release is investigated and the root cause determined. This investigation should include measures for:

* Restoring compliance as quickly as possible. * Preventing recurrence. * Assessing and mitigating any adverse environmental effects.

4.4 The corrective action is decided by the relevant Department Manager, in conjunction with the Management Representative. The effectiveness of the corrective action is monitored to prevent reoccurrence of the incident/release.

4.5 Following a thorough investigation, an environmental incident/release report form must be fully

completed during the investigation with the following information: (a) Name of originator (b) Date and time of incident/release (c) Details of the incident/release (d) Action taken to prevent reoccurrence (e) Any external communications required (f) Close out date and signature of Management Representative






Environmental Incident / Release Investigation & Reporting


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4.6 When the preventative action is complete the Management Representative must sign off the form and date it. All forms are filed and retained.

4.7 Where an incident or release has resulted in environmental pollution the Local Authority should be

informed. This should be indicated in the incident/release investigation form. Such communication will be dealt with as per SOP EN.049.

4.8 Management will review all environmental incident/release occurrences on a yearly basis, as part of

the management system review. This review should include an analysis of trends in the incidents/releases to see if changes are required in the future of the preventative programme or emergency procedures to further protect the plant from such occurrences.

5.0 Reference Documents:

5.1 Environmental Incident/Release Investigation Form – EHS010.

5.2 Environmental Management System Review - SOP No. EN.052 5.3 External Communications - SOP No. EN.049 6.0 Reason for revision






Environmental Incident / Release Investigation & Reporting


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Subject: EHS & Energy Management System Review 1.0 INTRODUCTION

The SOP outlines the procedure by which management will conduct a formal evaluation of the status and adequacy of the EHSMS and EnMS. Review will include evaluating policy and regulations and the formulation of new objectives resulting from changing circumstances.

2.0 SCOPE:

The scope of the new review should include the entire organisation and all its activities, products and services; it should not be confined to those relevant to existing policy, objective, and targets.

3.0 DEFINITIONS:

EHSMS = Environmental Health & Safety Management System, including Energy. EnMS = Energy Management System

4.0 RESPONSIBILITY

It is the responsibility of the Management Representatives to ensure that the necessary information is collected to allow top management to carryout a complete evaluation of the EHSMS and EnMS.

5.0 PROCEDURE

5.1 Senior Management shall review EHSMS and EnMS annually to ensure continuing suitability, adequacy and effectiveness. The Management Review shall address the possible need for changes to the MS in light of audit results, changing circumstances, legislation, concerns from interested parties and commitment to continual improvement to the following elements of the system:





EHS002 Effective By Date:21-May-2010Standard Operating Procedure Approved Date: 21-Apr-2010

EHS & Energy Management System Review


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- EHS & Energy Policy - EHSMS Objectives and Targets - Environmental & Energy Manual - EHSMS Register of Aspects

- EHSMS Operational Control - Health/Safety Risk Assessment - EHSMS Awareness - EHSMS Training

- Other elements of the system to reflect these changes - Progress and performance to meeting legislative requirements

5.2 EnMS Management Review 5.2.1 Inputs to the Annual EnMS management review include: a) Follow up actions from previous management reviews b) Review of energy aspects and the energy policy c) Evaluation of legal compliance and changes in legal obligations and other requirement to which AIC subscribes d) The extent to which the energy objectives and targets have been met e) Energy management system audit results f) Status of corrective and preventative actions g) The overall energy performance of the organisation h) Projected energy consumption for the following Abbott financial period i) Recommendations for improvement 5.2.2 Outputs from the EnMS management review include any decisions or actions related to a) The improvement in the energy performance of AIC since the last review b) Changes to the energy policy c) Changes to objectives, targets or other elements of the energy management system, consistent with AIC commitment to continual improvement d) Allocation of resources








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Selected outputs can be communicated to AIC employees to demonstrate how management review process leads to new objectives that will benefit the organisation.

6.0 REPCORD KEEPING

6.1 Findings, conclusions and recommendations reached, as a result of the review will be managed by EHS Department & stored on the EHS & E Drive.

7.0 FREQUENCY

7.1 The Plant Review shall be held at 12 month intervals or more frequently if dictated by changing activities, regulatory pressure, etc.


April 2010 - Per CR 208








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Subject: Internal Communications/EHSMS Awareness Programme

1.0 INTRODUCTION:

Abbott Cootehill continuously looks for opportunities to improve EHSMS performance. One significant way of achieving this is through employee involvement in the day to day running of the EHS Management System. This SOP outlines the steps to be taken in order to increase health & safety, environmental and energy internal communications awareness throughout the plant.

2.0 DEFINITIONS:

EHSMS = Environmental, Health & Safety Management System including Energy.

3.0 RESPONSIBILITY:

The responsibility to ensure that the necessary internal communications are conducted lies with the Management Representative: EHS.

4.0 PROCEDURE

4.1 There must be a segment included in the induction training programme to inform new and/or transferred employees with regard to key environmental and energy aspects of their job.

4.2 Supervisors and/or middle management training programme fosters and

develops the following aspects:

(a) Proper task instruction should be broadened to increase the awareness of employees to any health & safety, environmental & energy impacts of their task.

(b) Updating on key environmental issues, quality, cost, production or

safety issues as they arise in employee's work practice.

4.3 Supervisors/middle management should ensure that personnel contact is maintained on a routine basis.

4.4 Relevant EHS performance/information is made available to all employees

as soon as it is compiled via notice board, direct instruction from supervisors or fortnightly briefing system.






Internal Communications/EHSMS Awareness Programme (Ref.EHS)


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4.5 Ensure that there is an ongoing housekeeping promotion programme which includes all work and storage areas.

4.6 When relevant EHS issues arise, the Management Representative or any member of the EHS Team should put the information in the Fortnightly Briefing system. This may include issue pertaining to environment, health

& safety or energy.

4.7 Whenever the opportunity presents itself EHS awareness is further enhanced by posting relevant issues on the notice boards e.g. Engineering Dept. energy awareness and efficiency.

4.8 A Safety Memo is communicated to all employees on a weekly basis through email and/or Plasma Screen / Posters. This may include issues on Health & Safety, Environmental or Energy.

4.9 A two-way communication system is promoted whereby employees can

feedback any ideas/suggestions to their supervisors. 5.0 REASON FOR REVISION

Per CR 422






Internal Communications/EHSMS Awareness Programme (Ref.EHS)


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Subject: Setting EHSMS Objectives & Targets 1.0 PURPOSE The purpose of this procedure is to specify the method by which EHSMS objectives and targets are set and ultimately how their efficiency is monitored. 2.0 SCOPE This procedure applies to all Abbott personnel who are in involved in the setting, specification, reviewing and achievement of EHSMS objectives and targets. 3.0 REFERENCES/ATTACHMENTS None 4.0 DEFINITIONS

• An EHSMS Objective is defined as a broad goal that a company sets itself to achieve, arising from EHS/ Energy policy, EHS Strategic Plan or aspect evaluation and which is quantified wherever possible.

• An EHS Target is a detailed performance requirement, quantified where

possible, that arise from EHS or Energy objectives and that needs to be set and met in order to achieve these.

• EHSMS = Environmental Health & Safety Management System including

Energy 5.0 RESPONSIBILITY The management representative is responsible for ensuring that Abbott EHSMS objectives and targets are assessed. 6.0 PROCEDURE

6.1 The Management Representative and plant department managers shall develop a set of EHSMS objectives, which demonstrate a commitment to continual ongoing improvement in the company's environmental performance.

6.2 The objective should be clearly derived from and should develop a strong

linkage to the Register of Environmental & Energy Aspects, IPPC






Setting & Monitoring of EHSMS Objectives & Targets


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License, Health/Safety Risk Assessment and where applicable to the Register of Regulations and should be compatible with the company's EHS & Energy policy.

6.3 Objectives can be short term or can also be project managed over one or a number of years.

6.4 The EHSMS management programme shall specify the following information;

* Specific objectives and targets * Person responsible for achieving objectives/targets * The means by which they are achieved * Efficacy date by which they are achieved * Current status of objectives/targets

6.8 EHSMS objectives, targets and management programme are reviewed and where appropriate, updated at the EHSMS Team meetings and at the Management System Review.

6.9 When an objective/target has not been achieved, or when the management

representative decides that the objective/target cannot be achieved in the specified time scale, rescheduling of the object/target shall be recorded.

7.0 RECORDS

The management representative shall maintain the master copy of the Management Programme, Revision Index and the minutes of the Team meetings for reviewing the objectives/targets, for a minimum period of five years.


July 2009 - Per CR 311






Setting & Monitoring of EHSMS Objectives & Targets


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Basic Operating Procedure

Role:

Signed by:

Date (GMT):

Reason for signing:

Procedure to be followed in the Event of a Chemical Spillage Inside/Outsidethe Plant (Ref. ISO 14001)

Admin. Secretary Josephine M Connolly 07/11/2006 10:14:39 Initiating Route for Review

Operations Support Manager Sean A Curtin 08/11/2006 16:03:27 Initiating Route for Review

Human Resources Manager Seamus C Kennedy 09/11/2006 12:25:18 Initiating Route for Review

Label Copy & Reg. Co-ordinator Kathleen P Bredican 15/11/2006 16:10:21 Reviewed No Changes Required

Q.A. Manager Christina A Farnan 17/11/2006 09:50:25 Reviewed No Changes Required

Process Manager Gus J Mac Entire 05/01/2007 09:10:07 Reviewed No Changes Required

Electrical Engineer Brendan J Lynch 05/01/2007 09:45:00 Initiating Route for Review

Admin. Secretary Josephine M Connolly 18/01/2007 15:45:57 Route for Review Completed





EHS009 Effective Date: 18-Jan-2007Standard Operating Procedure Approved Date: 18-Jan-2007

Procedure to be followed in the Event of a Chemical Spillage Inside/Outside the Plant (Ref. ISO 14001)


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Subject: Procedure to be followed in the event of a Chemical Spillage

Inside/Outside the Plant (Ref. ISO 14001)

1.0 PURPOSE:

The purpose of this procedure is to ensure that spills inside/outside of the plant are expediently and effectively dealt with so as to prevent any adverse impact to the environment. Also that people know the procedure should they be affected by a chemical spill from a Health and Safety point of view.

2.0 RESPONSIBILITY: The responsibility to ensure that all drummed materials and waste are stored in a manner that minimises the risk, lies with the Manager of the area concerned. 3.0 PROCEDURE : Chemical Spill - Inside the Plant The maximum size of a container with chemicals stored inside the Plant is 5 litre Winchester Bottles.

3.1 Upon the occurrence or discovery of a chemical spillage, the Laboratory Manager is to be informed immediately. The Manager will assess the situation and will decide on a course of action.

3.2 The Manager may delegate personnel from his/her department to deal with

the spillage. For spillages involving materials hazardous to health or the environment, the Management Representative should be informed. The area should be isolated to keep out unauthorised personnel.

3.3 There should always be one individual observing the "Clean-Up" from a

safe distance so that if any further complications arise he/she will be able to get help.

3.4 The spilled chemical is to be identified and its associated hazards

established . This information should be available on the container. Consult the Material Safety Data Sheet for specific hazard and clean-up information and any particular precautions, such as personal protective equipment, that are required.








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3.5 The extent of the incident is to be quickly assessed and the fire alarm sounded if deemed necessary.

3.6 Fire fighting equipment must be in standby especially if the spilled

chemical is flammable. 3.7 Ventilate the building by opening doors.

3.8 Determine if the spillage can be washed into a process drain. If this is not possible or there is a risk of the spillage spreading and entering storm drains then it must be contained using absorbent material. All efforts must be made to prevent any spillage from entering a storm drain.

3.9 Using a shovel and a brush transfer the absorbed chemical into a lined

drum or other suitable container and label correctly. This material is to be left in the compound store with other hazardous waste, prior to disposal by an approved hazardous waste contractor.

3.10 An EHS Incident/Release Investigation report should be prepared on the

spillage by the supervisor and sent to the Environmental Representative.

3.11 Stocks of absorbent material must be replenished by the department in which they are used.

3.12 In the event of the chemical spillage in transit to the Laboratory, the

department manager of the relevant area should be informed immediately and the same procedure followed as for the Laboratory.

4.0 CHEMICAL SPILL (OUTSIDE THE PLANT) Chemical Spill - note:- the maximum size of container containing a chemical is 1,000 ltrs approx (IBC) to 20,000 ltrs (Bulk Road Tanker).

4.1 The process and/or the warehouse manager and the hazardous materials controller must be informed immediately, depending on the location of the IBC container/tanker.

4.2 Restrict all movement of traffic both entering or leaving the area. 4.3 Turn off all ignition sources immediately. 4.4 Ensure smoking is strictly prohibited.








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4.5 Have the area completely evacuated. All personnel should be sent to a safe designated area. Inform the Safety Officer

4.0 PROCEDURE CHEMICAL SPILL (OUTSIDE THE PLANT) (contd)

4.6 Obtain the necessary safety equipment (Breathing Apparatus may be required) Safety Goggles, Respirator, Apron, Gloves and Safety Shoes.

4.7 Shut off any leaks if appropriate and place absorbent materials around the

spill to soak up the chemical. Ensure Drain Covers are in place.

4.8 If the spillage emanated from a drum and if it is safe to do so, position it so that the ruptured section is uppermost thereby preventing further leakage.

4.9 There should always be one individual observing the procedure from a

distance so that if any further complications arise he/she will be able to get help.

4.10 Do not use fork trucks to move the material as there is a risk of sparks.

4.11 Transfer all the absorbent material used in the clean-up into the Compound store and arrange disposal with an approved hazardous waste contractor.

4.12 After the area is completely free of absorbent material and chemical, wash

with water and detergent. 4.13 The Supervisor of the area will inform all personnel when it is safe to

resume normal work and free movement of vehicles can resume. It is also the Supervisor's responsibility to ensure an Incident/Release Investigation Sheet is completed and sent to the Environmental Representative.

4.14 If liquid chemical has entered the surface drains or sewers it may be

necessary to inform the local Authorities, including the Fire Services if the chemical has flammable properties.

4.15 Procedures for handling other major spillages are provided in the Disaster

Control Manual. Also refer to EN 58 for dealing with Minor Sulphuric Acid Spills.








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5.0 SAFETY/HEALTH

5.1 If an employee is affected by a chemical spill go immediately to the First Aid Treatment Room, inform First Aid Person/Nurse through your Manager.

5.2 The material data sheet on the chemical will give the person the First Aid

Treatment that should be addressed. If there are Health effects such as Breathing Apparatus the person should go the doctor. The data sheets for chemicals are kept in the Laboratory.

6.0 DOCUMENTS REFERENCED Environmental Incident/Release Investigation Inspection Sheet No. EN 018 Disaster Control Manual Dealing with Minor Sulphuric Acid Spillages - EN 58 7.0 REASON FOR ERVISION

7.1 Environmental Incident/Release Investigation Inspection Sheet revised and replaced with EHS 010 EHS Incident/Release Investigation Form.

7.2 BOP renumbered from HR to EHS and converted format to Microsoft

Word. 7.3 Added to point 4.0 IBC to 20,000 lts.

7.4 Annual Review October 2005 – No Changes Made. 7.5 Annual Review October 2006 – No Changes Made.








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1.0 INTRODUCTION

The purpose of this SOP is to establish a procedure for the maintenance, update and review of the Register of Environmental, Health & Safety & Energy Legislation, to record all legislative, regulatory and other policy requirements and codes applicable to the environmental and energy aspects of Abbott’s activities, products and services.

2.0 RESPONSIBILITY

It is the responsibility of the E.H.S. Co-Ordinator to maintain a system for the recording of all legislative, regulatory and other policy requirements. Responsibility for annual review / update of the Register of Legislation is the responsibility of the Environmental Co-Ordinator. The Environmental Co-Ordinator operates from the Abbott Ireland Headquarters.

3.0 LEGAL & OTHER REQUIREMENTS

3.1 Abbott Ireland, Cootehill, use the Corporate ENEHSA, a legislative tracking system to identify, report and analyse legal requirements, which relate to environmental, health & safety & energy.

3.2 The Facilities Integrated Pollution Prevention & Control (IPPC) License,

Corporate Standards, Guidelines & Energy Agreements Programs are used to outline the “other requirements” to which ANSC take into account in the development, implementation and maintenance of an effective EHSMS.

3.3 A review of legal and other requirements is performed on a regular basis

to ensure ANSC EHSMS is managed in accordance with legislation and best practice.

4.0 INTERPRETATION OF LEGISLATION

4.1 The Register of EHS&E Legislation is reviewed by a member of the EHS Department to ensure that all the legislation relevant to Abbott ordered in that year is interpreted in summary form and included in the Register of Legislation Manual. The annual review should be carried out at the time of expiry of that year’s subscription for the Government Publications list.

4.2 In the event of a particular piece of Legislation requiring immediate

attention, the co-ordinator will issue a non technical summary to the Management Representative within a month of the legislation being issued.






EHS Register of Legislation


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5.0 REFERENCES Register of Legislation Manual Environmental Legislation Index 6.0 REASON FOR REVISION

Per CR 423






EHS Register of Legislation


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1.0 SCOPE

To identify the elements of products, activities or services which can affect energy usage. 2.0 RESPONSIBILITY

This procedure will be relevant to all staff. Engineering and EHS Departments along with senior management representatives will be responsible for identifying the energy aspects associated with company activities and assessing the significance of any potential energy impact.

3.0 DEFINITIONS

Energy Aspect “element of an organisation’s activities, products or services that can affect energy use”. Energy Efficiency “the achievement of a desired output through use of the minimum energy input.”

4.0 PROCEDURE

4.1 Any new or potential energy aspects shall be assessed for their significance. The trigger to this could be:

• The introduction or modification of new products, processes or services, • Changes to legislation and other regulations, • The views of interested parties, • Any communications received, • And / or any other relevant information.

The means of identifying the above should be through Management reviews and through new plant/equipment EHS Checklists.

4.2 The scope should also include a consideration of the aspects arising, or likely to arise as a

consequence of:

• Direct (i.e. those, which arise directly from the company’s operations over which it is able to exercise control).

• Indirect (i.e. those arising from activities remote from the company’s site or immediate environment and are largely beyond its control).

• Past, current and planned activities. • Normal, abnormal and emergency situations.

4.3 For each aspect identified a full impact evaluation should be completed to determine the

significance. Questions on frequency, usage amount, controls and legal compliance shall be answered and the appropriate score selected.

Table 1: Energy Impact Evaluation

Frequency Continuous Energy Usage 5 <12hrs/day 4






Significant Energy Aspects Evaluation


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<8hrs/day 3 <4hrs/day 2 <1hrs/day 1

Electricity Usage kilowatt (kw) (refer to power demand inventory in new Reg of aspects spreadsheet, Planning, IS393,

Energy folder on drive) >200 kw 5 100-200 kw 4 50-100 kw 3 10-40 kw 2 0.1-10 kw 1

Gas Oil Usage litre (l) (refer to power demand inventory in new Reg of aspects spreadsheet, Planning, IS393,

Energy folder on drive) >106 litre 5 >56 litre 4 >16 litre 3 >15 litres 2 <15 litres 1

Propane Gas Usage litre (l) (refer to power demand inventory in new Reg of aspects spreadsheet, Planning, IS393,

Energy folder on drive) >10,000 litres 5 >8000 litres 4 >6000 litres 3 >4000 litres 2 <4000 litres 1

Water Usage (m3) (refer to power demand inventory in new Reg of aspects spreadsheet, Planning, IS393,

Energy folder on drive) >4000m3 5 >2000m3 4 >1000m3 3 >500m3 2 >500m3 1

Steam Pounds per week Usage (Ib/week) (refer to power demand inventory in new Reg of aspects spreadsheet, Planning, IS393,

Energy folder on drive) >6M Ib/week 5 >3M Ib/week 4 >1M Ib/week 3 >0.5M Ib/week 2 <0.5M Ib/week 1

Controls No control 5 Medium Control 4-2 Good Control 1








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Legal Compliance Breaches legislation 5 Bordering legislation / don’t know 4 Within direct legislation 3 Well in control of legislation 2 Indirect legislation 1

4.4 The significance should then be calculated by multiplying the scores in each category. 4.5 Establish the relationships between energy aspects and associated energy factors in each practicable instance and record this on a separate register. 4.6 Review of the evaluation scores and energy factors should be taken to decide where

appropriate to set objectives and targets to reduce the significance. The significant energy aspects selected for objectives and targets should be those where legal requirements need to be met or with the highest scores where possible. Scores deemed to be significant are those ≥90.

4.7 Significant energy aspects can cover other areas that offer considerable potential for energy savings (as well as those identified by the aspects review/scoring mechanism).

Management Review

4.8 During reviews the aspects should be looked at and any aspects, which are no longer relevant to the company’s activities, shall be removed. The register of significant energy aspects shall also be reviewed annually where existing aspects shall be reviewed and discussed. This may include changing the level of significance, depending on the meeting of objectives and targets.

5.0 REFERENCE

5.1 Please refer to the Register of Factors and the Register of aspects found in the Energy Folder on the EHS&E Drive. Personnel whose work may have an impact on significant energy use are identified in this register 5.2 Please refer to the opportunities selection procedure in the Energy Manual, Register of Opportunities, Evaluation of Compliance Register and Objectives and Targets which can all be found in the Energy Folder on the EHS&E Drive. 6.0 TRAINING REQUIREMENTS 6.1 Training shall be documented using the HR033 Form and/or Compliancewire. 7.0 REASON FOR REVISION

April 2010 – Per CR 209








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1 Introduction

1.1 Scope

This SOP outlines how plant energy efficiency data is monitored, measured and recorded.

1.2 Objective

The objective of the SOP is to outline how plant utility data is assembled and processed to generate plant energy KPI data.

1.2 Definitions/Abbreviations

I.S. EN 16001: European Energy Management Standard

2 Responsibilities

2.1 It is the responsibility of the engineering department to assemble energy data and generate weekly energy KPI data.

2.2 It is the responsibility of the engineering department to calibrate all energy instrumentation and software.

3 Procedure

3.1 Plant utility data is collected from a number of different sources. The various sources are outlined below:

3.1.1 Esight software: oil, compressed air, electrical main/submeter data.

3.1.2 Electrical supplier website: plant overall electrical demand

3.1.3 OEE software system: Production data

3.2 Esight software monitoring system

Esight software monitors the following data and can be internet accessed via http://abtiesc07/esight.






Energy Monitoring


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There are over 70 plant meters monitored by Esight i.e. plant, electrical, oil, steam, compressed air, refrigeration, effluent, CIP, Water demands in various areas around the site.

Esight send out daily graphs by email with regard to D1, D2, P1, P2, Boiler

utility demands.

3.3 ESBIE website

The electrical power supplier data is available and collected to the website

outlined below.

http--esbie.ie-.url






Energy Monitoring


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This website can generate daily / weekly / monthly reports. It also outlines electrical supply tariffs where applicable.

3.4 OEE software system

The OEE is selectable from many plant wide personal computers. The program can be selected from the main screen icons. This software outlines production data for packing and wet process production plants between any two selectable dates. This OEE report also outlines lost production time and the reasons for that lost production time.






Energy Monitoring


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Overall energy reporting document

3.5 All energy data which is collected from the above sources are collated in the Cootehill Energy management spreadsheet. This file assembles all information with regard to I.S. EN 16001. This data is collated by the energy engineer or the engineering secretary on a weekly basis. All collated energy data is stored on the EHS & E computer drive folder or/and the Esight software database. The collated energy data is used to generate weekly KPI data/reports. See attached sample below.






Energy Monitoring


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The Plant KPI tab of the above file assembles all the information and generates the following KPI ratio data.






Energy Monitoring


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4.0 KPI Outline

Annual Plant KPIs Target KPIs

1. Lbs packed / liter oil ratio 6.9 Lbs/litre 2. Lbs packed / Kwh ratio 3.4 Lbs/Kwh

Primary KPIs Target KPIs

3. Weekly Lbs packed / liter oil ratio 6.1 Lbs/litre 4. Weekly Lbs packed / Kwh ratio 3.0 Lbs/Kwh

Secondary KPIs Target KPIs

5. Weekly Lbs processed / Liter oil ratio 6.1 Lbs /litre 6. Weekly Lbs processed / Kwh ratio 3.0 Lbs / Kwh 7. Weekly Boiler kg steam / liter oil ratio 10.8 Kg

steam/litre

The weekly KPI data is communicated to senior management for review on a weekly basis. If any KPI is outside of target range, a non conformance will be raised and investigated. Secondary KPI non conformances do not necessitate a corrective action procedure. Secondary KPIs are used to investigate primary KPI non conformances.

5.0 Calibration of Monitoring Equipment

The instrumentation associated with energy monitoring will be calibrated checked and maintained by contractors and site electricians in accordance with site ATLAS software preventative maintenance program.

6.0 Reason for Revision: 2010 June - Per CR 209






Energy Monitoring


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1. Introduction:

1.1 The purpose of this procedure is to put in place a programme to ensure that members of the public can obtain information concerning the environmental performance of the IPPC license, and the Greenhouse Gas Emissions Trading Permit and any reports submitted to the EPA in relation to the license and the permit at all reasonable times, and to document communications from interested parties, external complaints and follow up corrective action. AIC plan to communicate Energy Management System information externally, a programme of communication shall be documented.

2. Scope: 2.1 This SOP applies to all Abbott personnel receiving enquiries/external

complaints, by telephone, in writing or by personal contact.

3. Procedure: Interested Party Enquiry

3.1 All interested party queries shall be directed to the EHS & Operations Support

Manager or in his absence Human Resources Manager, or the Engineering Manager, or an Abbott Cootehill representative nominated by any of the fore mentioned.

3.2 Interested parties include the local community, Local Authorities,

Fisheries Officers, local schools, queries from nearby neighbours etc. All queries must be responded to as quickly as possible, with an initial response within 24-48 hours.

3.3 The Abbott Ireland representative will ascertain the validity of the enquiry i.e. name, address, organisation/company, query, etc. by completing External Communication Form (EN 045). Each record shall give details of the nature of the query/complaint and the response given. In the case of a complaint, the EPA must be notified during the month following the complaint. This information shall be maintained in the Register of External Communications.

3.4 When deemed necessary, an interested party enquiry shall be facilitated with an inspection of the IPPC license or the GHG Emissions Permit and

all relevant reports that have been issued to the EPA, and a tour of the Cootehill operation if applicable to the query.

Queries/Complaints

3.6 All external queries/complaints shall be directed to the EHS and

Operations Supports Manager or the HR Manager or in their absence the Engineering Manager. Where necessary the EHS & Operations Support






External Communications/Complaints


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Manager shall liaise with the relevant personnel internally in order to effectively deal with the query/complaint. Details of the complaint shall be entered on the External Communications Form EN 045,under the following headings: # Name and Address of the person making the query/complainant. # Phone number if applicable. # Time &Date of the query/complaint. # Nature of complaint. # Response given.

3.7 Complaints/queries will be maintained in the Register of External

Communications. Where deemed necessary, copies shall be sent to Dept. Managers and other key persons.

3.8 The complaint will be investigated and the root cause determined. Communication to the complainant will be completed as soon as possible after the facts are established. A report will be submitted to the EPA during the month following the complaint.

3.9 Any proposed corrective action will be monitored by the EHS & Operations Support Manager or HR Manager to ensure that the desired goals are met, i.e. restoring compliance and preventing recurrences.

3.10 The EHS & Operation Support Manager or HR Manager will, following discussion with management, inform the external complainant by phone of the proposed ameliorative action taken, if applicable.

3.11 A report on all External Communications shall be reported to

management at the EHS Management Review Meeting.

General

3.12 Abbott Cootehill will where necessary re environment performance communicate with the E.P.A. local authority and Fisheries, any abnormal environmental situations in the plant. The responsibility for this lies with the EHS & Operations Support Manager, or in his absence the HR Manager, or in the case of the absence of both of these the Engineering Manager. The External Communication Form EN 045 should be documented in the same manner as for complaints/queries.

3.13 Abbott Cootehill Management will communicate with its suppliers/ customers in the interest of enhanced environmental performance.








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3.14 Any communication, environmental safety health incident involving the media shall be directed to the Human Resources Director for Abbott Ireland.

3.15 Communications received centrally should be copied to the plant by completing the External Communication Form for information purposes.

External Energy Management System Plan

3.16 AIC external communication plan is detailed in table 1. Records of the communication shall be retained as detailed on the Records Register (EHS&E Drive).

Table 1: Energy Management System External Communication Plan Organisation Information Means File Location Frequency Responsible SEAI LIEN annual

report Spreadsheet EHS&E Drive

on AIC Computer

Annual EHS Coordinator

EPA IPPC Annual Environmental Reporting

Electronically and hardcopy

EHS&E Drive on AIC Computer & Public File

Annual EHS Coordinator

4. References:

4.1 External Communications Form - Inspection Sheet No. EN045

4.2 Register of External Communications 5. Reason for Revision:

April 2010 – Per CR 209








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1. INTRODUCTION:

1.1 The Purpose of this SOP is to identify and document all non-compliances and to ensure the relevant authorities are informed. The procedure also ensures that the route cause of the non-compliance is determined and investigated. Following investigation corrective action will be implemented and compliance restored as quickly as possible and recurrence prevented.

2. SCOPE

2.1 This SOP applies to all non-conformances and subsequent corrective and preventive actions in relation to the following:

• All IPPC license non-compliances

• Breeches of Emission Limit values

• Failure of Monitoring equipment

• Failure of Abatement equipment

• Notices of Violation (NOV’s)

• All breaches of EHS policy

• Non-conformances as result of a Regulatory inspection or Audit. • All breeches of energy management system including Energy KPI breeches and internal audit non-conformances.

3 DEFINITIONS/ABBREVIATIONS.

Non Compliance- Includes Environmental, Health and safety and energy non-compliances

IPPC – Integrated Pollution Prevention Control

EPA – Environmental Protection Agency

ELV – Emission Limit Value

EHS&E - Environmental and health and safety & Energy





EHS031 Effective Date: 18-May-2010Standard Operating Procedure Approved Date: 18-May-2010

EHS Non-Conformance


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EHS - Environmental and health and safety

EHS&E Drive - Network drive used by EHS dept.

Action Management - Electronic tracking database.

H.S.A. - Health & Safety Authority

EHSNC001 - EHS Non-Conformance Spreadsheet

NOV – Notice of Violation: defined as any written citation received from a Regulatory body identifying a perceived nonconformance with any applicable EHS requirement. The term does not include letters of warning or other pre notice Correspondence.

Inspection: defined as any on-site visit from a regulatory agent for the purpose Of establishing facility conformance with applicable EHS requirements.

Reportable Incident: defined as any EHS incident/ emergency that requires either by regulation or by Abbott EHS Global Standard No. T15 to be reported to a regulatory agency (e.g. H.S.A., E..P.A.) and/or Abbott Laboratories Senior Management.

Exceedence of Regulatory Limit Values: defined as any singular instance of a measured nonconformance with required numeric emission limitations, whether by issued license, permit, or otherwise.

4 RESPONSIBILTY:

4.1 Department Managers have the following responsibilities: 4.1.1 Ensure that all non-compliances are reported in their area 4.1.2 Ensure corrective and preventive actions have been completed.

4.2 Employees have the following responsibilities:

4.2.1 Report any non-conformances to the EHS dept. as soon as possible. EPA incidents must be reported to EHS Dept immediately.

4.3 EHS coordinator has the following responsibilities:

4.3.1 To ensure that all non-conformances have appropriate corrective and preventive actions allocated.






EHS Non-Conformance


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4.3.2 Ensure corrective and preventive actions have been closed out within acceptable timeframes.

4.3.3 Report relevant non-conformances to the regulatory agencies, i.e. EPA, Cavan and Monaghan County Council, Northern Fisheries Board, Health & Safety Authority if required.

4.3.4 Report all NOV’s, exceedences of ELV’s and Reportable incidents to the Abbott Divisional EHS representative.

4.3.5 Track all non-conformances and include in performance measures.

5. PROCEDURE:

5.1 Following the notification of an Environmental non –conformance the EHS Coordinator shall ensure that an EHS Non- compliance form has been completed as per EHS002.

5.2 The EHS Coordinator shall assess the EHS non compliance form to see if it there

has been a non-conformance of a license condition and/or of an Abbott standard. 5.3 All Health, Safety & Environmental & Energy non-conformances shall be tracked

using a Non conformance spreadsheet (EHSNC001) saved in EHS&E drive and in Action management and/or using the Cootehill Environmental Health and Safety Database (Action Items Review Database).

5.4 The Environmental Representative shall ensure that the EPA (in the event of an

IPPC non-conformance) is notified by fax and a phone call as soon as practicable. Within 48 hours. The EHS Representative shall follow up in writing with any additional corrective and preventative actions if necessary.

5.5 In the event of an Abbott Non-Conformance the Environmental representative

shall notify within 24 hours of the Divisional EHS Representative. 5.6 In the case of a NOV or a regulatory exceedence these shall be reported

each month in the EHS monthly report and in the quarterly metrics in Action Management.

6 RECORDS:

All EHS records will be retained for a period of Forty years unless otherwise stipulated on documentation. All EHS records will be retained by the EHS dept






EHS Non-Conformance


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7 TRAINING REQUIREMENTS

All employees shall be trained on this procedure. Training shall be documented using the HR033 Form and/or on Compliance Wire.

8 REASON FOR REVISION: April 2010 – Per CR 210






EHS Non-Conformance


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1. PURPOSE

1.1. This procedure outlines the method for the collection of data required for the monitoring and reporting of CO2 emissions required by the Greenhouse Gas Emissions Trading Permit.

2. RESPONSIBILITY

2.1. It is the responsibility of the Environmental & Operations Support Manager to ensure that accurate information on the combustion of fuels is maintained for the Abbott Ireland Cootehill site.

2.2. And that CO2 emissions are reported to the EPA in accordance with the conditions of the Greenhouse Gas Emissions Trading Permit

3. PROCEDURE

3.1. All Gas Oil deliveries are recorded by the Boiler Operator in the Boiler House

Log Book

3.2. Delivery dockets with the printed quantities are filed in a box file and stored in the boiler house. A new box file must be used for each year.

3.3. Oil usage is recorded in the boiler log book for each day

3.4. Oil Stocks are recorded on a daily basis

3.5. Deliveries of Generator Gas Oil and stocks are also recorded in the Boiler House log book

3.6. Each month the quantity of oil received during the month are recorded in an Excel spreadsheet by the EHS Department.

3.7. Deliveries are matched to the invoices by Accounts Payable department

3.8. Finance department reports oil Usage and the tonnes of CO2 for each month.

3.9. Deliveries are crosschecked with stocks to ensure accuracy.

3.10. Oil for the Firewater pumps is ordered from a local supplier and deliveries are recorded in the boiler house logbook. Stocks are recorded at the beginning of each year.

3.11. LPG stocks are recorded at the beginning of each year; all deliveries and invoices are matched and recorded in the Excel spreadsheet by the EHS Department.






Emission Trading In-House Procedure


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3.12. All invoices and delivery dockets must be made available to the Verifier and EPA personnel as required.

3.13. Internal audit of procedure is on audit schedule to be audited twice per year.

4 RISK ASSESSMENT

LEVEL OF RISK HAZARD

H M L CONTROL MEASURES TO BE TAKEN

TO REDUCE RISK RESIDUAL

RISK

Oil delivery not documented

M

Security onsite 24 hours 7 days a week, security log, copy of daily log held by HR Dept. Security notify the Boiler Operator, when the lorry arrives onsite. The lorry drives to the oil delivery area to offload. The Boiler Operator takes tank gauge reading before and after delivery. This is used as a cross check between the delivery docket. The oil intake log is completed and signed by the Boiler Operator and the lorry driver. Boiler Operator obtains a copy of the delivery docket and maintains it on file. The oil tank gauge is read every morning and usage recorded daily. Finance Department are billed, they match the invoice with the delivery docket and maintain on file.

L

Procedure not carried out when Boiler Operator is on holiday

M Utility Operators (x2) are trained on the procedure and

available when required. L

Computer System Crashing

M

There are backups for the network, lines and a disaster recovery plan is in place. Network Attached Storage box network can be used if the server goes down. Backups are performed once per month and stored for one year. There are also 2 Netopia routers and a VPN system. There are 3 available lines and a point to point back up line. As part of the Disaster recovery plan the remote site in Dublin is tested annually.

Typing error

M Internal auditing of the Emission Trading procedure is

scheduled twice per year. All inputted data on the Emission Trading Spreadsheet is checked as part of the internal audit.

L

5. DOCUMENTS REFERENCED

5.1 Greenhouse Gas Emissions Permit No. IE- GHG099-02 5.2 Statoil Delivery Dockets 5.3 Statoil Invoices 5.4 Boiler House logbook 5.5 Local fuel oil supplier delivery dockets and invoices. 5.6 Calor-Kosangas invoices for LPG








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5.7 Emission Trading Spreadsheet located on the EHS&E drive in Environmental Management Folder within Emission Trading Folder.

6. TRAINING

6.1 All relevant employees shall be trained on this procedure. Training shall be documented using the HR033 Form and/or Compliancewire.

7. RECORDS

7.1 All records will be retained indefinitely.

8. REASON FOR REVISION:

8.1 New SOP








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1.0 INTRODUCTION

1.1 The purpose of this document is to ensure written procedures are in place to minimize the risks and liabilities associated with the Abbott Ireland, Cootehill (AIC) dangerous goods/hazardous materials transportation program. There are also additional area-specific procedures that must also be followed.

1.2 Additionally, this procedure defines the minimum requirements for responding to

transportation incidents involving dangerous goods/hazardous materials.

1.3 This SOP is also in compliance with Technical standard T03 on Dangerous Goods and Hazardous Material.

2.0 SCOPE

2.1 This procedure outlines minimum requirements applicable to AIC for the shipment or transport of dangerous goods/hazardous materials. These requirements are in addition to those contained in applicable laws and regulations.

3.0 DANGEROUS GOODS/HAZARDOUS MATERIALS TRANSPORTATION COORDINATOR (DGTC)/ DANGEROUS GOODS SAFETY ADVISOR (DGSA)

3.1 The designated Dangerous Goods / Hazardous Materials Transportation

Coordinator (DGTC) or also known as Dangerous Goods Safety Advisor (DGSA) is Ciarán Sexton, as agreed upon by the Environmental and Operation Support Manager. The DGSA is responsible for distributing relevant dangerous goods/hazardous materials information that could impact the site programs.

4.0 DEFINITIONS & KEY TERMS

4.1 Dangerous Good/Hazardous Materials – means and includes “Hazardous Substances”, “Dangerous Goods”, “Hazardous Materials”, and “Hazardous Waste” as defined by any applicable law or regulation for the country of origin or destination. The terms “Dangerous Good” and “Hazardous Material” shall be synonymous. Dangerous Goods/Hazardous Materials may also include chemicals, intermediate goods, and finished products leaving Abbott sites (including Abbott to Abbott transportation).

4.2 Dangerous Goods Shipment and Transportation Regulations – means and includes

regulations that govern the proper shipment and transportation of dangerous goods/hazardous materials via air, highway, rail, and water. Examples may include the International Civil Aviation Organization (ICAO), International Maritime Organization (IMO), and all applicable country-specific transportation regulations.

4.3 Dangerous Goods/Hazardous Materials Transportation Coordinator (DGTC) /

Dangerous Goods Safety Advisor (DGSA) – means any person(s) who has knowledge of the applicable dangerous goods transportation regulations and has been designated as the coordinator for an organization or site. Within AIC, the DGSA is Ciarán Sexton unless otherwise delegated by the Environmental and Operation Support Manager.





EHS037 Effective By Date:07-Jun-2009Standard Operating Procedure Approved Date: 08-May-2009

Hazardous Materials Transportation Programme


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4.4 Dangerous Goods/Hazmat Employee – means a person who during the course of employment:

5.4.1 loads, unloads, or handles hazardous materials as defined by the applicable

transportation regulations; 5.4.2 manufacturers, tests, reconditions, repairs, modifies, marks or

otherwise represents container, drums, or packaging as qualified for use in the transportation of hazardous materials;

5.4.3 prepares hazardous materials for transportation (e.g. employees responsible for packing hazardous materials or completing shipping papers);

5.4.4 is responsible for safety of transporting hazardous materials; or operates a vehicle used to transport hazardous materials (e.g. vehicle drivers).

4.5 International Civil Aviation Organization (ICAO) – means the committee that uses the

United Nations recommendations to develop and regulate the safe transport of dangerous goods/hazardous materials by air. The ICAO code has been incorporated in the International Air Transport Association (IATA) and U.S. regulations by reference and direct adoption.

4.6 International Maritime Organization (IMO) – means the committee which publishes the

International Maritime Dangerous Goods Code in accordance with Chapter VII of the International Convention for the Safety of Life at Sea. The IMO Code has been incorporated into the U.S. regulations by reference and direct adoption.

4.7 Shipment/Shipping Process – means the process of identifying, classifying, packaging,

marking, labeling, documenting, loading, or otherwise preparing a hazardous material for transportation.

4.8 Transportation – means the conveyance or movement of materials on a transport

vehicle by public highway, rail, air, or water. 4.9 Transportation Incident – with respect to dangerous goods/hazardous material means

any event that occurs during the course of transportation and is classified as a significant Environmental, Health & Safety incident (as defined by Abbott Laboratories Global EHS Technical Standard T15) or any reportable release to the environment per applicable regulations.

4.10 Transportation Document – means shipping papers, bill of freight, hazardous waste

manifests, Shipper’s Declaration for Dangerous Goods, hazardous material move tickets and any other document required to be signed by a hazmat/dangerous goods employee that is used to communicate the basic description, quantity and packaging for a shipment of dangerous goods.

4.11 epartment of Enterprise, Trade and Employment – means the Government Agency

specifically charged with regulating the shipment and transportation of dangerous goods/hazardous materials in Ireland.

5.0 POLICY & PROCEDURES

5.1 COMMUNICATION OF NEW AND PROPOSED SHIPPING and

TRANSPORTATION REGULATIONS

5.1.1 All new and proposed ICAO, IMO and other applicable








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shipping and transportation regulations will be communicated from the DGSA or EHS Department to Dangerous Goods/Hazardous Materials employees by email, training, workshops, or other media distribution techniques.

5.2 INSTRUCTIONS FOR THE TRANSPORTATION OF DANGEROUS GOOD/HAZARDOUS MATERIALS

5.2.1 Research Compounds/Small volumes of hazardous materials: Person(s) wanting to ship a research compound should first reference the compound’s Material Safety Data Sheet, and/or contact the DGSA to determine if the shipment will meet the definition of a dangerous good/hazardous material. Proper documents must be executed (e.g. Chain of Custody, Confidentiality Agreement) as necessary.

5.2.2 Regulated-Waste Shipments: Manifested shipments of regulated waste must be

conducted only by Abbott employees specifically trained in both hazardous materials transportation and waste management procedures. Only carriers who maintain the proper and current legal permits to transport the waste being offered by Abbott are authorized to transport manifested wastes. Specific examples of proper transportation permits include those associated with hazardous or other waste classified as a hazardous material for transportation purposes.

All dangerous goods/hazardous materials transportation shipments originating in AIC must follow the instructions within this procedure. The DGSA must be notified if: • a hazardous materials/dangerous goods transportation inspection from

an external agency is requested at Cootehill site, or • if questions arise regarding a hazardous material/dangerous goods

shipment’s proper classification, packaging, labeling, marking, paperwork, or

• for any hazardous material/dangerous goods transportation activity not addressed by this procedure.

5.3 PROHIBITED TRANSPORTATION OF MATERIALS

Abbott employees are prohibited from personally transporting any volume of dangerous good/hazardous material or other material that could pose a safety hazard associated with Abbott interests using personal vehicle or any other mode of public transportation. If a Governmental agency requests from Abbott Ireland, Cootehill a sample of a dangerous good/hazardous material for purposes of governmental interest (i.e. approval, clinical trial, analysis, demonstration, or research) – the party of request must first obtain written approval from the DGSA supporting the site.

5.4 EMERGENCY RESPONSE AND NOTIFICATION

5.4.1 Emergency response information for AIC site’s dangerous goods/hazardous materials being transported must be provided directly to the Emergency Response Provider or to the site DGSA or designee, who will then supply the information to the emergency response organization as required.

5.4.2 If a dangerous good/hazardous material package being shipped or transported

is found to be leaking, the DGSA must be contacted immediately for an








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assessment of the situation and subsequent notification or reporting as warranted.

5.4.3 A dangerous goods/hazardous materials transportation incident must be

reported to the GEHSE Global Dangerous Goods Group no later than the close of business on the day following the incident. The site DGSA, along with input from those immediately involved will complete an incident investigation and submit the relevant information to the GEHSE Global Dangerous Goods Group per current requirements.

5.4.4 In cases where a hazardous material/dangerous good is released in a quantity

equal to or greater than its reportable quantity (RQ), the site DGSA must work expeditiously with Global Environmental Health, Safety & Energy group to report the release to the National Response Centre.

5.4.5 In cases where a Dangerous Goods Transportation Incident initiates reporting

under Abbott Laboratories Global EHS Technical Standard T15 (Significant EHS Incident Reporting and Management), reporting requirements in T15 will take precedence.

6.0 TRAINING

6.1 EACH DANGEROUS GOODS/HAZARDOUS MATERIALS EMPLOYEE MUST RECEIVE TRAINING RELEVANT TO THEIR JOB FUNCTION THAT INCLUDES ELEMENTS OF THE FOLLOWING:

6.1.1 General Awareness –

• designed to provide familiarity with the requirements of the hazardous materials/dangerous goods regulations (e.g. packaging, labeling, marking, recordkeeping, training, placarding);

• enable the employee to recognize and identify dangerous goods/hazardous materials.

6.1.2 Function Specific Training –

• designed to train employees on dangerous goods/hazmat transportation requirements and exemptions specifically applicable to the functions the employee is assigned to perform (e.g. training issued for compliance with ICAO/IATA shipments).

6.1.3 Safety Training –

• emergency response information to be implemented for dangerous goods/hazmat transportation incidents (e.g. use of Materials Safety Data Sheet or the Emergency Response Manual);

• measures to protect the employee from the hazards associated with hazardous materials to which they may be exposed in the workplace, including measures that Abbott has implemented to protect employees from potential exposure; and








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• methods and procedures for avoiding accidents, such as the proper procedures for handling packages containing hazardous materials.

6.2 INITIAL AND RECURRENT TRAINING REQUIREMENTS FOR THE TRAINING ELEMENTS OF SECTION 7.1

6.2.1 Initial Training –

6.2.1.1 A new dangerous goods/hazmat employee or one that has changed job functions may perform those functions prior to the completion of training provided the employee performs those functions under the direct supervision of a properly trained and knowledgeable dangerous goods/hazmat employee and the training is completed within 90 days after employment or change in job function.

6.2.2 Recurrent Training –

6.2.2.1 Dangerous goods/hazmat employees must receive the required elements of dangerous goods/hazmat transportation training at least once every two (2) years.

6.3 RECORDKEEPING

6.3.1 Each dangerous goods/hazmat employee’s training record that is specifically associated with the shipping or transportation of hazardous materials shall be maintained for the duration of that employee’s job function plus 90 days thereafter. The training records shall contain:

6.3.1.1 The hazmat employee’s name; 6.3.1.2 The most recent hazmat training completion date; 6.3.1.3 A description, copy, or reference to the location of the training materials used to meet the training requirements; 6.3.1.4 The name and address of the person/organization providing the training; and 6.3.1.5 Certification that each hazmat/dangerous goods employee

was trained and tested.

6.3.2 A copy of the shipping papers (e.g. bill of lading, manifest, shipper’s declaration), or an electronic image thereof, associated with hazardous material/dangerous goods must be retained by the AIC operating area indefinitely. For a hazardous waste, mixed waste, or other waste regulated for transportation purposes - the shipping paper copy must also be retained indefinitely.

6.3.3 All relevant employees shall be trained on this procedure. Training shall be

documented using the HR033 Form and/or Compliancewire. 7.0 REFERENCE DOCUMENTS

Abbott laboratories global EHS Technical Standard T-03 (Dangerous Goods and Hazardous Material)








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1. Introduction 1.1 The purpose of this procedure is to define the Abbott Ireland, Cootehill (AIC) procedure with

regard to the safe handling, segregation, storage, and disposal of the hazardous waste generated at the facility. This procedure documents the management of Hazardous waste under segregation, storage, record keeping, labelling, transportation, and disposal requirements as per legislative requirements.

1.2 Hazardous waste is both a potential source of environmental contamination and a health a safety

risk, and as such must be handled and disposed of in line with current legislation and with minimum risk to the environment.

1.3 This SOP is also in compliance with Technical standards T04 on Waste Disposal Facility

Selection and T10 on Waste Management. 2. Definitions / Abbreviations 2.1 AIC: Abbott Ireland Cootehill 2.2 AER: Annual Environmental Report 2.3 EPA: Environmental Protection Agency 2.4 MSDS: Material Safety Data Sheets 2.5 IPPCL: Integrated Pollution Prevention Control licence 2.6 GEHS: Abbott Global Environment Health and Safety 2.7 A hazardous waste is defined primarily by reference to 14 different characteristics, which render

such waste hazardous. These characteristics are as follows; H1 Explosive H2 Oxidising H3 Flammable H4 Irritant H5 Harmful H6 Toxic H7 Carcinogenic H8 Corrosive H9 Infectious H10 Teratogenic H11 Mutagenic H12 Substances, which may release toxic gases. H13 Substances capable of yielding a hazardous leachate H14 Ecotoxic






Hazardous Waste Management


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2.8 European Waste Catalogue (EWC): definitive EU list of wastes based on origin each waste type

given a unique 6-digit code. 2.9 Waste: any substance, which the holder disposes of or intends to or is required to dispose of. 2.10 Hazardous waste: as defined in the Waste Management Act 1996 “Waste listed in Category 1 of

Part 1 of the 2nd schedule of WMA…or...waste listed in Part 2 and has properties specified in Part 3 …or…such other waste having properties specified in Part 3.

2.11 ADR: means the European agreement concerning the International Carriage of Dangerous Goods

by Road Regulations. 2.12 S.I. means ‘Statutory Instrument’. 2.13 DGSA means ‘Dangerous Goods Safety Advisors’. 2.14 Dangerous goods means those substances and articles the carriage of which is prohibited by

ADR, or authorized only under the conditions prescribed therein, and in accordance with the recommendations of the site DGSA

2.15 Carriage means the change of place of dangerous goods, including stops made necessary by

transport conditions and including any period spent by the dangerous goods in vehicles, tanks and containers made necessary by traffic conditions before, during, and after the change of place Carrier means the enterprise, which carries out the transport operation with or without a transport contract.

2.16 Competent authority means the authority or authorities or any other body or bodies designated as

such in each State and in each specific case in accordance with domestic law. 2.17 Consignor means the enterprise, which consigns the dangerous goods either on its own behalf or

for a third party, i.e., the originator of the waste. 2.18 Consignee means the enterprise, which takes charge of the dangerous goods on arrival after

carriage, i.e., the receiver of the waste. 2.19 Consignment means any package or packages, or load of dangerous goods, presented by a

consignor for carriage. 2.20 UN number means the four-digit identification number of the substance or article taken from the

UN Model Regulations. 2.21 A Consignment Note (C1) document is required to transport hazardous waste by road, with the

exception of waste oil, within Ireland. 2.22 A Transfrontier Shipment form (TFS) is required to transfer hazardous waste from Ireland to

another state/country.








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2.23 List I As listed in the EC Directives 76/464/EEC and 80/68/EEC and amendments. 2.24 List II As listed in the EC Directives 76/464/EEC and 80/68/EEC and amendments. 3. Responsibility 3.1 Department Managers have the following responsibilities

• Ensure that this procedure is adhered to • Ensure proper facilities storage facilities are available on site for the correct storage and segregation of waste.

3.2 Team Leader/Supervisors have the following responsibilities

• Ensure that this procedure is adhered to • Ensure that hazardous waste generated in their area is placed in correct bags or containers and

labelled with the contents. • Ensure that hazardous waste generated in their area is segregated correctly • Ensure that hazardous waste is bought to the designated “Hazardous Waste” holding areas on site.

3.3 Employees have the following responsibilities

• Ensure that this procedure is adhered to. • Ensure that hazardous waste bags are labelled with contents • Ensure that hazardous waste bags are not overfilled and are tied off when full with cable ties • Ensure that hazardous waste is brought to the designated “Hazardous Waste” holding area. • This “hazardous waste” holding area must be kept tidy at all times.

3.5 Environmental & Operations Support Manager /EHS Coordinator has the following

responsibilities • Ensure that all employees are aware of and adhere to this procedure. • Ensuring that the facility is in compliance with all legislative aspects for the safe management of all hazardous waste generated on site. • Select and audit hazardous waste transfer stations and final disposal sites. • Obtain approval from the EPA for the use of any new hazardous waste facility or final disposal site.

3.6 The DGSA (Ciarán Sexton or designee) is responsible for

• Labelling all hazardous waste prior to it being removed off site. • Draw up an Annex for submittal to the hazardous waste carrier identifying, the waste, its EWC code, quantity and date for collection. • For ensuring all hazardous waste is transported in suitable UN approved drums, IBC’s and tankers. • Must check all the paperwork of any dangerous goods carrier, which comes to site to remove hazardous waste. • Sign and take copy of documentation (C1 and TFS) prior to a Hazardous waste shipment

leaving site.








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• Maintain a file of all hazardous waste shipments for inspection on an internal audit or by an external agency.

4. Safety/Environmental: 4.1 Instructions outlined in this document must be strictly adhered to, to protect human health, safety,

and the environment. • Abbott’s Safety and Environmental procedures should be complied with in full • The assigned PPE should be worn when handling hazardous wastes and dangerous goods, consult the chemical risk assessments to ensure you have the correct PPE. • Employees should work in twos if they are transferring waste from one container to another. • AIC does not permit the transfer of any empty or other chemical containers to AIC employees or others for personal use. This applies whether or not the containers have been cleaned or rinsed. • Empty chemical containers may also be suitable for use as waste containers. UN approved fibre- keg drums may be used as receptacles for compatible solid waste. Similarly IBC’s, which stored a raw material, can be used for the storage of a similar waste. All previous labelling is removed and the container properly re-labelled as required. • The DGSA shall maintain an up-to-date inventory of all hazardous waste stored on-site. • AIC shall not dispose of or recover Hazardous waste on-site • Clean up and report any chemical spills to the Environmental & Operations Support Manager /EHS Coordinator • Only an approved waste haulier and waste disposal contractor shall be used.

5. Procedure 5.1 Segregation

• Flammables to be stored in separate container • Chlorinated solvents to be separated form non chlorinated solvents • Formaldehyde waste to be in separate container • Toxics to be stored in separate container • Acids packed in separate container • Bases (Alkalis) in separate container • Oxidizers stored in separate container • Inorganic peroxides stored in separate container • Mercury – pure metal, or items containing mercury packed separately. • Potent product – do not remove from the original container (i.e sample container), double bag place in an open top Fibre drum. • If you are unsure of the compatibility of chemical please consult the DGSA/Environment Manager. • Light bulbs – store in “Lamp coffin” at Refrigeration MCC Room in Engineering. • Batteries – store in double lined container at Refrigeration MCC Room in Engineering.

5.2 Storage








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• All containers holding waste material should be stored so that they are easily accessible, the amount of handling required to remove them is minimised and if a leak occurs it should be easily identified and dealt with. • Drums should only be filled to 95% capacity to allow room for expansion. • Hazardous waste bags should not be overfilled and should be tied off with cable ties. • All hazardous waste generated on site must be stored and contained within an area with secondary containment. These areas must be kept secure at all times. • These storage areas must be kept tidy at all times, ensure any waste left in these areas are labelled. • All storage containers must be in good condition, any containers that have swelling, major Indentations, or severe rusting should be replaced and have their contents re-drummed. • AIC shall make a reasonable and responsible effort to prevent the spillage of material during the transport and dumping of all hazardous wastes.

5.3 Labelling and Documentation

• Each department generating a hazardous waste shall insure that all bags, drums, IBC’s generated in their area, has a written label indicating what it contains. • On the day of collection, the hazardous waste disposal contractor for each drum provides all labels, IBC etc, which identifies it by a UN number and the details of its contents and hazards. The DGSA ensures labels are in place prior to removal from site. • The DGSA or designee ensures that appropriate EWC and UN numbers are used on the documentation. • A consignment Note (C1) document and a Trem card must accompany all Hazardous waste with the exception of waste oil, WEEE and medical waste transported within Ireland. A C1 document is obtained from the local Authority where the Hazardous waste originates. • Transfrontier Shipment Form must accompany all Hazardous waste when the waste is being transported outside the country. A copy of this document should be made available by the waste contractor and should be retained on file. • The carrier representative and the site DGSA sign the C1 form. The DGSA retains the pink copy, i.e., Consignor’s copy. The remaining copies are retained by the carrier The White Copy is the Carrier’s copy – to be given to the carrier of the waste, after completion of Part C by the consignee, and retained by the carrier representative and accompany the waste while in transit in Ireland. • When the hazardous waste disposal contractor intends to ship waste for disposal, they complete the transfrontier shipment forms, notify the relevant local authorities in the jurisdiction of the disposal site, and upon receipt of approval from the local authority the shipment is moved to that site. • A certificate of acceptance must be made available by the disposal contractor to ensure that the waste has arrived safely and has been accepted into the transfer station. The DGSA keeps this document on file with a copy of the C1. • A certificate of disposal must be made available from the disposal company to ensure that the waste has been disposed of correctly.

5.4 Shipment of Waste from site

No Hazardous waste shall leave AIC site unless both the driver and the transport vehicle are fully compliant.








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When AIC require a Hazardous Waste Shipment to be made, the person requesting that shipment contacts the DGSA and gives him or her details of the shipment. • When the DGSA gets details of the shipment he then contacts the Waste Disposal Company giving those details of the shipment, and books that shipment for collection. He also requests a Hazchem Driver for the collection. • On arrival the DGSA shall carry out all relevant checks on both the vehicle and the driver to ensure ADR compliance. • All the paperwork is completed and signed. • When checks are completed and verified, label all the Hazardous Waste according to the updated information on the Annex forwarded by the Waste Disposal Company with the driver. When all the Waste has been labelled and verified it is then loaded onto the truck for transporting to the Waste Disposal Company. Ensure all the paperwork is completed and signed.

6 System Review

• The Environmental & Operations Support Manager /EHS Coordinator shall communicate all data in relation to the management of hazardous waste at the AIC site as part of Annual Environmental Report • The Environmental & Operations Support Manager /EHS Coordinator will provide details of hazardous waste metrics to GEHS twice per year • The Environmental & Operations Support Manager /EHS Coordinator will provide details of hazardous waste management activities at Management Review Meetings.

7 Training

All relevant employees shall be trained on this procedure. Training shall be documented using the HR033 Form and/or Compliancewire.

8 Records

All records of waste disposal must be maintained permanently on site. 9 Reason for Revision:

Per CR213








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1.0 Scope This SOP provides the IPPC responsibilities of Abbott employees and outlines the monitoring of the Cootehill site’s IPPC license. Table 1 illustrates the list of monitoring points.

Table 1 – List of emission/monitoring points IPPC Emission Point Description A1-1 Boiler House A1-2 Boiler House A2-3 Boiler House A2-1 Dryer Tower Roof A2-2 Dryer Tower Roof ASW1 Dromore River Testing Upstream ASW2 Dromore River Testing Downstream SW1 Surface water emission point SW2 Surface water emission point GW1 Ground water well 1 GW2 Ground water well 2 GW3 Ground water well 3 NSL 1 Kearns Residence to the north west of the site -Reading was taken in the back garden of Kearns with full view of plant NSL 2 O’Brien’s Residence to the west of the plant – Reading was taken in back garden of O’Brien’s NSL 3 Reading was taken at Bellamont House to the south east of the site NSL 4 Amenity Park – to south of site NSL 5 Margaret's Lane – to north of the site along a local road and adjacent to residence on local road 2.0 DEFINITIONS/ABBREVIATIONS.

AER-Annual Environmental Report AIC- Abbott Ireland, Cootehill EPA - Environmental Protection Agency EHS - Environmental Health and Safety IPPCL - Integrated Pollution Prevention Control License GEHS - Global Environmental Health and Safety PM – Preventive Maintenance

3.0 RESPONSIBILTY: 3.1 Department Managers have the following responsibilities

Provide the Environment and Operation Support Manager/EHS Coordinator/Utilities Engineer with support and/or information as necessary to allow for effective management of environmental emissions.





EHS040 Effective By Date:01-Jun-2009Standard Operating Procedure Approved Date: 30-Apr-2009

IPPCL Monitoring


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3.2 Supervisors have the following responsibilities Operate and maintain plant operations so as to be in compliance with the conditions of the IPPCL. Operate and maintain all abatement equipment so as to be in compliance with the conditions of the IPPCL. Engineering personnel shall operate and maintain all continuous monitoring equipment so as to be in compliance with the conditions of the IPPCL. Report any non conformances or environmental incidents as per SOP EHS 012 to the Environment and Operation Support Manager/EHS Coordinator. Provide the Operation Support Manager/EHS Coordinator/Utilities Engineer with support and/ or information as necessary to allow for effective management of environmental emissions. Provide the Operation Support Manager/EHS Coordinator/Utilities Engineer with support and/ or information as necessary to allow for effective scheduling of monitoring of environmental emissions. Ensure that EHS inspections are conducted as per SOP EHS 033.

3.3 Employees have the following responsibilities

Provide the Operation Support Manager/EHS Coordinator/Utilities Engineer with support and/ or information as necessary to allow for effective management of environmental emissions. Ensure that EHS inspections are conducted as per SOP EHS 033.

3.4 Environment and Operation Support Manager/EHS Coordinator have the following

responsibilities If there is a breach of environmental emission report to the relevant regulatory authority as per SOP EHS 031/EHS 030. Maintain all records related to environmental emissions. Establish and maintain an Environmental Management System which fulfils the requirements of the licence. Incorporate objectives and targets into the Environmental Management Programme on an annual basis to ensure the continual improvement of environmental issues on site. Ensure under condition 2 of IPPCL to forward reports to the EPA as outlined in appropriate schedules.

4.0 PROCEDURE:

AIC shall provide safe and permanent access to the sampling and monitoring points listed in Table 1 and safe access to any other sampling and monitoring points required by the Agency.






IPPCL Monitoring


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As per condition 11 of the IPPC licence, Monitoring, AIC will carry out sampling, analyses, measurements, examinations, maintenance and calibrations as set out in Schedules:-

Schedule 1(ii) Emissions to Atmosphere: Abatement/Treatment Control, Schedule 1(iii) Monitoring of Emissions to Atmosphere, Schedule 2(ii) Effluent Treatment Control, Schedule 2(iii) Monitoring of Emissions to Water, Schedule 3(iii) Waste Analysis, Schedule 4(i) Surface Water Discharge Monitoring, Schedule 4(ii) Groundwater Monitoring, Schedule 4(iii) Monitoring of the Dromore River, Schedule 4(iv) Noise Monitoring,of the licence. Under condition 12 of the licence AIC shall forward reports to the EPA as outlined in Schedule 5(i) Recording and Reporting to the Agency. All automatic monitors and samplers shall be functioning at all times (except during maintenance and calibration) while AIC is operational. If monitoring equipment shall malfunction AIC will notify the EPA, as soon as practicable, and alternate sampling and monitoring systems shall be put in place. Monitoring equipment shall be maintained so that it can monitor an accurate/ representative sample from the emission point. All such equipment shall be consistent with the safe operation of all sampling and monitoring systems.

4.1 Emissions to Atmosphere (Condition 5 of IPPCL)

Monitoring and analyses of each emission shall be carried out as specified in Schedule 1(iii) Monitoring of Emissions to Atmosphere of the licence. There are three licensed emission points to the atmosphere from the Boiler House (A1-1, A1-2, A1-3), and two from the Dryer Tower Roof (A2-1 & A2-2). Monitoring of boilers shall be carried out biannually by an external contractor. Monitoring of dryers shall be carried out quarterly by an external contractor. A report on the results of this monitoring shall be submitted to the Agency on a quarterly basis and a summary report of emissions to atmosphere submitted to the Agency as part of the AER. AIC has installed a bag filter to comply with condition 5.2 of the IPPCL “The licensee shall install a bag filter in dryer A2-1 to limit dust emissions to 20 mg/m3 by 30th October 2007.” Boilers shall be operated so as to give a smoke colour less than or equal to shade number 1 on the Ringelmann chart except during periods of start up. Such start up periods shall not exceed 30 minutes in any 24 hour period.

4.2 Emissions to Water (Condition 6 of IPPCL)

There are two emission points to the Dromore River from the AIC site. The first (SW1) consists of a mixture of uncontaminated surface water runoff and condensate (from the Similac product only). The second (SW2) consists of effluent from the Wastewater Treatment Plant. These streams are kept separate until the point of discharge to the Dromore River. Separate sampling chambers allow for monitoring of each stream individually.






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Monitoring point SW2 has continuous emissions monitoring for flow (no exceedence alert), pH (Alarms only on out of range pH), Temperature (no exceedence alert), and COD (measured by a S:Scan COD WaveLength Spectrometer, which constantly measures COD & TSS every 2 – 5 minutes and alarms Engineering when exceeds programmed limits). AIC determine the normal COD range for the inlet stream. The inlet stream automatically diverts to the dump tank in the event of the COD exceeding the normal range.

Monitoring of Effluent Treatment shall be carried out as per Schedule 2(ii) Effluent Treatment Control of IPPCL.

Monitoring and analyses of emissions to water shall be carried out as specified in Schedule 2(iii) Monitoring of Emissions to Water of IPPCL. A report on the results of this monitoring shall be submitted to the Agency quarterly and summary reports of emissions to water submitted to the Agency as part of the AER.

Biotic Index monitoring shall be carried out biannually and submitted to the EPA as part of the AER. Monitoring of ambient monitoring points, one upstream and one downstream of the effluent discharge, shall be carried out as specified in Schedule 4(iii) Monitoring of the Dromore River and the results submitted as part of the AER.

4.3 Waste Management (Condition 7 of IPPCL)

Sludge from Wastewater treatment plant is analysed biannually in accordance with Schedule 3(iii) Waste Analysis of IPPCL.

4.4 Noise (Condition 8 of IPPCL)

Monitoring of noise sensitive locations (Table 1) shall be carried out annually as per IPPCL requirements and SOP EHS 011 Noise Monitoring and Audiometry.

4.5 Non-Process Water Emissions (Condition 9 of IPPCL)

Currently surface water is monitored continuously. Action and trigger limits have been established by AIC and any exceedance of these limits must be investigated and appropriate action taken. A visual examination of the surface water discharge and weir operation shall be carried out daily. A log of such inspections is maintained by Engineering. AIC shall monitor surface water discharges in accordance with Schedule 4(i) Surface Water Discharge Monitoring of this licence. A report on the results of this monitoring are submitted to EPA quarterly and a summary report submitted as part of the AER. In the event that any analyses or observations made on the quality or appearance of surface water runoff should indicate that contamination has taken place, AIC shall: (i) carry out an immediate investigation to identify and isolate the source of the contamination, (ii) put in place measures to prevent further contamination and to minimise the effects of any contamination on the environment, (iii) and notify the EPA as soon as is practicable. All groundwater monitoring points are included in AIC maintenance programme. Groundwater monitoring points GW1 to GW3 shall be sampled and analysed in accordance with Schedule 4(ii) Groundwater Monitoring of this licence. A report of such results are submitted annually as part of the AER.






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In order to minimise possibility of water contamination all bunds are on a PM and are visually checked weekly. The log is held in the Engineering Department. All bunds shall be tested at least once every three years as per IPPCL requirements. A report on such tests shall be included in the AER.

AIC shall undertake a programme of testing and inspection of active underground tanks and pipelines to ensure that all such structures are tested at least once every three years. A report on such tests shall be included in the AER.

All flanges and valves on over-ground pipes used to transport materials other than uncontaminated water, where no permanent provision for containment of leaks is provided, are subject to weekly visual inspection/monitored for leaks. All inspections shall be recorded in a log which shall be available for inspection by the Agency. The log is held in the Engineering Department.

If there is an environmental release an environmental non-compliance form shall be completed and closed out as per SOP EHS 031. In the event of a non-conformance with parameters of the IPPCL, the Environment & Operational Manager/ EHS Coordinator shall communicate the situation with the EPA & all relevant authorities, as soon as practicable as per SOP EHS 030.

5.0 REFERENCE:

IPPCL Reg. No. P0-687-01 SOP EN028 Effluent Treatment Plant SOP EHS 011 Noise Monitoring and Audiometry SOP EHS 031 Non-Conformance SOP EHS 030 External Communications/Complaints

6.0 RECORDS:

All records shall be maintained for at least 7 years as per the IPPCL and longer if specified in the EHS records register/technical standard.

7.0 TRAINING REQUIREMENTS:



New SOP






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1 INTRODUCTION 1.1 Scope

This documents outlines how plant energy internal communications will be conducted in relation to energy performance and ensure that persons at all levels in the organization are encouraged and facilitated to make proposals for improvements and submit relevant comments on the energy management system.

1.2 Objective This document outlines how internal energy communications are carried out and ensures that all site personnel can take an active part in energy management at Abbott Cootehill and assist in improving the site energy performance. This SOP relates to I.S. EN 16001 Energy Management Standard.

1.3 Definitions/Abbreviations I.S. EN 16001: European Energy Management Standard

Level 1 communication: Weekly communication of plant KPI data to plant managers Level 2 communication: Regular energy team meetings Level 3 communication: Regular energy communications to all site staff Level 4 communication: Collection and evaluation of energy suggestions from site employees to energy team.

2 RESPONSIBILITIES 2.1 It is the responsibility of the Engineering Department to communicate level 1 and 2 energy

updates.

2.2 It is the responsibility of EHS Department to communicate level 3 energy updates to the workforce at Abbott Cootehill.

2.3 Both the EHS & Engineering Department are responsible for Level 4 communications.

3 PROCEDURE 3.1 Abbott Cootehill has developed a four tier procedure for plant energy internal communications.

Level 1: Weekly communication of plant KPI data to plant managers Level 2: Regular energy team meetings Level 3: Regular energy communications to all site staff Level 4: Collection and evaluation of energy suggestions from site employees to energy team.






Energy Communication


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3.2 Level 1

The Engineering Department will send a weekly plant energy update via email to

1. Production supervisors and senior production management 2. Engineering senior manager and department engineers 3. Plant manager 4. Energy team

These reports will be stored within Lotus notes email system. 3.3 Level 2

There are regular energy team meetings. This meeting reviews:

1. Plant energy demand relative to plant energy KPIs 2. Plant progress with respect to Corporate energy goals 3. Progress with project implementation 4. Energy monitoring problems and developments 5. Evaluation of energy suggestions 6. Energy non conformances

The minutes for all above meetings will be stored in the Energy Folder on the EHS&E Drive.

3.4 Level 3

The EHS Department will communicate energy information to site personnel using a number of means including

1. Energy Policy 2. Energy Manual 3. Site biweekly newsletter 4. EHS Memos 5. EHS Newsletter 6. Plant notice boards 7. Energy awareness campaigns 8. Energy awareness events/ days. 9. Energy training

3.5 Level 4

All site employees can send energy saving suggestions to either the EHS or the Engineering Department. This communication can sent by following means








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1. Email 2. Verbal communication with above persons 3. EHS&E suggestion boxes

The EHS & Engineering Department are responsible for ensuring that all energy suggestions received are incorporated to the energy opportunities register. The EHS & Engineering Department will be responsible for reviewing the energy saving feasibility of the suggestion and responding to the originator of the suggestion. If a suggestion is deemed feasible, the suggestion will be incorporated into the plant engineering annual plan/Energy objectives or actioned as appropriate.

4.0 TRAINING REQUIRMENTS


5.0 REFERENCES Energy records are stored in the Energy Folder on the EHS & E Drive.

6.0 REASON FOR REVISION April 2010 - Per CR 210








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_____________________________________________________________________________________________________

Attachment C.2.2

Environmental Objectives & Targets

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ENVIRONMENTAL & ENERGY OBJECTIVES - AN Cootehill - Version 1

Obj No Status

OBJ1

OBJ2

OBJ3

OBJ4

OBJ5

OBJ6

OBJ7

OBJ8

OBJ8

OBJ9

OBJ10

Reduce water use by 20% per unit produced from a 2008 baseline by 2015

Reduce energy use by 20% per unit produced from a 2008 baseline by 2015

31st Dec 2011

31st Dec 2011

To Promote & create environmental awareness

Target Date

To achieve Abbott environmental exceedence goal

Aim for zero waste to landfill by 2012 Plant 31st Dec 2012

Completion DateObjective Description Responsible Person

Reduce total waste generation by 10% per unit produced by 2015 from a 2008 baseline

Plant

Plant

Plant

Plant

Reduce greenhouse gas emissions by 20% per unit produced from a 2008 baseline by 2015

To further improve Management of IPPCL & GHG Permit Activities

To further develop the Environment & Energy Management Systems

Continue to enhance & futher develop the Energy Champion & Management Team

Ensure compliance with legal and company requirements

Petrina Ashford

Plant

Plant

Petrina Ashford

EHS&E Teams

EHS&E Teams/Utilities

31st Dec 2011

31st Dec 2011

31st Dec 2011

31st Dec 2011

31st Dec 2015

31st Dec 2015

31st Dec 2015

31st Dec 2015

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ENVIRONMENTAL & ENERGY TARGETS 2011 - Abbott Ireland Cootehill

Target No Linked to

Objective No.

T1 1

T2 1

T3 2

T4 3

T5 3

T6 4

T7 5

T8 6

T9 7

T10 8

T11 9

T10 10Eliminate dependance on landfill sites EHS &E Department 31st Dec 2011

Reduce waste production EHS &E Department 31st Dec 2011

Target Description Responsible Person Target Date Completion Date

To achieve a Division Abbott Environmental Exceedence Goal 31st Dec 2011AN Cootehill

31st Dec 2011

To integrate Environmental and Energy Management Systems in line with the requirements of ISO 14001:2004

and I.S EN 16001:2009Petrina Ashford 31st Dec 2011

Record environmental significant incidents and spillages in Action Management

Implement a refresher environmental and energy training programme (refresh every 3 years)

Petrina Ashford 31st Dec 2011

Run awareness programmes to educate staff on energy and environmental aspects and programmes

Petrina Ashford 31st Dec 2011

Develop the Energy Champion Team and Energy Mgt Team Petrina Ashford 31st Dec 2011

To have front line management trained in energy and environmental mgt responsibilities

EHS &E Department 31st Dec 2011

Reduce demand on natural water resources EHS Department 31st Dec 2011

Petrina

100% Compliance with all Abbott Global Technical & Management Standards

All Management 31st Dec 2011

Reduce demand on fossil fuels & reduce emissions EHS&E/Engineering 31st Dec 2011

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Target No

Linked to

Objective No.

T1 1

T2 1

T3 2

T4 3

T5 3

T6 4

T7 5

T8 6

T9 7

T10 8T11 9T10 10

ENVIRONMENTAL & ENERGY TARGETS 2010 - Abbott Ireland Cootehill

ongoing

Sean/Petrina

100% Compliance with all Abbott Global Technical & Management Standards

All Management Dec.'10 Dec.'10

Reduce demand on fossil fuels & reduce EHS&E/Engineering Dec.'10 Dec.'10

Dec.'10 Dec.'10

Achieved, weekly compliance review meetings

Reduce demand on natural water resources

EHS Department Dec.'10 Dec.'10 ongoing

Dec.'10 Dec.'10

Implemented in training plan, regional support rolling it out

2011Develop the Energy Champion Team and

Energy Mgt Team Petrina Ashford Dec.'10 Dec.'10 Achieved

To have front line management trained in energy and environemtnal mgt

responsibilitiesEHS &E Department

partially achieved, new ISO std for energy management in June

2011

Record environmental significant incidents and spillages in Action

Management

Achieved. Earth Day & promotion week; Repak recycling Week;

Energy Awareness Week (18 to Implement a refresher environmental

and energy training programme (refresh every 3 years)

Petrina Ashford Dec.'10 Dec.'10Implemented with training

department

Run awareness programmes to educate staff on energy and environmental

aspects and programmesPetrina Ashford

To integrate Environmental and Energy Management Systems in line with the requiremnts of ISO 14001:2004 and

I.S EN 16001:2009

Petrina Ashford Dec.'10 Dec.'10

Dec.'10 Dec.'10

Completion Comments

ongoing

To achieve a Division Abbott Environmental Exceedence Goal

Dec.'10 Dec.'10 AchievedAN Cootehill

Target Description Responsible Person Target DateCompletion

Date

ongoingEliminate dependance on landfill sites EHS &E Department Dec.'10 Dec.'10 ongoing

Reduce waste production EHS &E Department Dec.'10 Dec.'10

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_____________________________________________________________________________________________________

C.3 - Page 1

Attachment C.3 (a) Proposed Hours of Operation:

The facility is currently in operation 7 days per week, 24 hours per day, on a shift basis. There are 3 x 8-hour shifts per day.

The plant only shuts down for the summer and Christmas shutdown periods for maintenance, normally for 2 week periods.

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