Attachment K.1 Residuals Management · PDF filethe process of being prepared and this Residuals Management Plan (RMP) is prepared in order to furnish the information required in Section

Attachment K

Attachment K.1

K.l.l Residuals Management Plan

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Centocor Project BioCork

111 ' Q

Centocor Project No: 422522

PM Project No: 101050.00 CRB Project No: 045205.00

Q

RESIDUALS MANAGEMENT PLAN I # .

File No. 101050.22.050 Document No: 101050-22-RP-0017

e

I I I I I I

CRB Plymouth Meeting, PA, USA T (610) 278 7644 F (610) 278 9194

www.pmq.ie PM Cork Ireland T +353 21 453 8922 F +353 21 435 8933, E cork&pmq.ie www.crbusa.com

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http://www.crbusa.com

Centocor Biologics (Ireland) Ltd 101 050-22-RP-0017 Residuals Management Plan 26th October 2005

CON TENTS

RESIDUALS MANAGEMENT PLAN

CONTENTS

1.

2.

3.

4.

5.

6.

EXECUTIVE SUMMARY

INTRODUCTION

2.1 Facility and Licence Details

2.2

SITE EVALUATION

3.1 Facility Description and History

3.2 Site reference condition

3.3 Facility Compliance Status

3.4 Facility Processes and’Activities

3.5

CLOSURE CONSIDERATIONS

4.1 General

4.2

4.3

4.4 Plant Disposal or Recovery

4.5 Waste Disposal or Recovery

4.6 Soil or Spoil Removal

IMPLEMENTATION OF RESIDUALS MANAGEMENT PLAN 5.1 Production Areas

5.2 Utilities

5.3

5.4 Laboratory Areas

5.5 Canteen and Kitchen

5.6 Wastewater Treatment Plant

5.7 Warehouse

5.8 Other Areas

CRITERIA FOR SUCCESSFUL CLOSURE

Facility Closure Scenarios covered in this Plan

Inventory of Site Buildings, Plant, Raw Materials and Wastes

Clean or Non-Clean Closure Declaration

Plant or Equipment Decontamination Requirements

Offices, Administration, Reception and Security

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Centocor Biologics (Ireland) Ltd 101050-22-RP-0017 Residuals Management Plan 26th October 2005

7.

8.

9.

10.

17 CLOSURE PLAN COSTING

7.1 Decommissioning Costs

7.2 Facility Security and Staffing

7.3 Total Cost

7.4 Funding of Residuals Management Plan

CLOSURE PLAN UPDATE AND REVIEW

8.1 Proposed Frequency of Review

8.2 Proposed Scope of Review

CLOSURE PLAN IMPLEMENTATION

9.1 Statutory Authority Notifications

9.2

CLOSURE PLAN VALIDATION

I O . 1 Closure Validation Audit

10.2 Closure Validation Audit Report

Full or Partial Closure Considerations

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@ Centocor Biologics (Ireland) Ltd 101050-22-RP-0017 Residuals Management Plan 26'h October 2005

1. EXECUTIVE SUMMARY Centocor Inc. is a global leader in biopharmaceuticals and a wholly owned subsidiary of Johnson & Johnson (J&J), the worldwide manufacturer of healthcare products. Centocor is investing in a major new Biomedicines Manufacturing Facility at a 50 hectare (ha) greenfield site in Barnahely, Ringaskiddy, Co. Cork. The f500m project will employ an estimated 330 people when fully operational. The new facility in Ringaskiddy will be capable of manufacturing a range of Centocor products, specifically antibodies and/or therapeutic proteins derived from mammalian cell cu I t u re.

An application for an Integrated Pollution Prevention and Control (IPPC) Licence is in the process of being prepared and this Residuals Management Plan (RMP) is prepared in order to furnish the information required in Section K of the IPPC Licence Application, addressing the remediation, decommissioning, restoration and aftercare of the facility. This RMP is based on the Environmental Protection Agency's (EPA's) (Draft) Guidance Documents and Assessment Tools on Environmental Liabilities Risk Assessment and Residuals Management Plans incorporating Financial Provision Assessment.

In addition, as part of Johnson & Johnson Sustainability Practices Environmental Planning Policy, it is Centocor's responsibility to ensure that any business transaction involving the divestiture of a facility, should be preceded by an environmental due diligence to assess and quantify potential environmental liabilities associated with the transaction.

An initial screening and operational risk assessment of the facility indicated that the facility lies in the medium risk category. The risk assessment does not show any likelihood of significant residual liabilities.

Centocor has no current plans to decommission part or all of the site. Two possible scenarios in the event of a shutdown of the facility were considered:

0 Do-Nothing

0 Do-Something.

The do-nothing scenario describes the situation of potential risks if the facility was vacated without implementing the RMP. The do-something scenario describes the potential risks if the plan was implemented. It should be noted that a do-nothing scenario is not consistent with the divestiture policy of Johnson & Johnson, and hence Centocor. Consequently, Centocor proposes to implement the do-something scenario, i.e., implement the RMP.

The scope of this plan addresses the key issues, which would occur in an orderly shutdown of all the site activities on a phased basis over an estimated time period of 3-6 months. The basis of the plan is to ensure that, upon completion of the plan, the facility would be in a suitable state for future industrial use and its condition would not pose a risk to public health and safety or the environment.

It is not intended to remove all structures or systems from the site. In general, specialist equipment will be distributed to sister plants in the event of a shut down.

Centocor intends to utilise existing staff resources to form a team to manage and execute the plan, supplemented where appropriate by outside resources. This Residuals Management Team would be responsible for managing and executing the

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complete plan. Outside contractors required for cleaning, waste disposal, incineration or recycling activities would be fully approved and licensed.

It is estimated that the duration of decommissioning and decontaminating would be 3 to 6 months. Environmental monitoring would continue while the plan is in operation and for a period following the completion of the plan to be determined by the EPA and/or local authority. The EPA and the local authority would be informed of the results of the monitoring programme and of the status of the plan.

Particular actions are required for specific areas of the facility as part of the Residuals Management Plan (RMP). In general, care and attention will be given during the implementation of the plan to ensure that the potential risks associated with the plan are avoided. In the event of a spillage, leak or fire during decommissioning, Centocor's Emergency Plan would be fully implemented in order to minimise the risk to health and the environment.

The costs associated with decommissioning are generally related to the disposal and recycling of equipment and the use of external resources to implement the RMP. In certain instances, costs will be recouped through the sale of equipment or materials.

It is expected that external resources will be required in order to implement the RMP in full. A list of these resources and associated costs is shown in Table 1 below.

Item Transportation of reactors, harvest tanks, laboratory equipment to another Centocor facility Waste treatmentldisposal costs Contract cleaning and decontamination Civil and structural, mechanical, electrical and instrumentation contractors (20,000 manhours at €50/hr)

professional consultancy Subtotal Contingency (25%) Total

Environmental Due Diligence Audit by

Table 1: Decommissioning Costs

Estimated Cost (€) 50,000

10,000 70,000

1,000,000

100,000

1,230,000 31 0,000

1,540,000

It is estimated that a cost of approximately El.54m would be incurred to decommission the site, including external resources costs.

A number of staff members would be required to remain on site for a period of 3-6 months to successfully implement the Residuals Management Plan.

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Staff requirements are estimated as follows:

Management 2 Security 4 Laboratory 3 Administration 2 Other staff 5

The cost of continuing to employ these staff members is expected to be in the region of €500,000.

On completion of the clearance of the site, the asset will be sold; pending sale the site will be supervised by Security. Depending on the commercial arrangements appropriate at the time, this responsibility may by undertaken by a liquidator. The cost of this supervision is likely to be no more than €100,000 at 2005 prices.

The total cost associated with executing a Residuals Management Plan at the Centocor site is therefore estimated to be in the region of E2.14m.

Centocor confirms that the company has more than adequate resources from operations to fund the Residuals Management Plan. In addition, the value of the facility itself as a fixed asset worth in excess of E300m will far outweigh any remediation cost.

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Centocor Biologics (Ireland) Ltd 101050-22-RP-0017 Residuals Manaaement Plan 26th October 2005

2.

2.1

I NTROD UCTl ON

Facility and Licence Details Centocor Inc. is a global leader in biopharmaceuticals and a wholly owned subsidiary of Johnson & Johnson, the worldwide manufacturer of healthcare products. Centocor has been delivering innovative biomedicines for more than 25 years and currently employs 4,500 people across its existing operations. Centocor's products are developed primarily through monoclonal antibody technology (or Biotechnology).

Centocor is investing in a major new Biomedicines Manufacturing Facility at a 50 hectare (ha) greenfield site in Barnahely, Ringaskiddy, Co. Cork (refer to Section D of the IPPC Licence Application for a Site Location Map). The E500m project will employ an estimated 330 people when fully operational. The new facility in Ringaskiddy will be capable of manufacturing a range of Centocor products, specifically antibodies and/or therapeutic proteins derived from mammalian cell culture.

An Environmental Impact Statement (EIS) was prepared in accordance with the requirements of the European Communities (Environmental Impact Assessment) Regulations, 1989 to 2001, and the Local Government (Planning and Development) Regulations, 2001, and was submitted with the planning application on the 15'h of April 2005. Planning Permission was granted by Cork County Council for the Centocor Biomedicines Facility in July 2005 (Cork County Council Planning Ref. No. 05/2431). Construction of the biornedicines facility commenced on the 25'h of July 2005 and is expected to be complete by August 2007.

An application for an Integrated Pollution Prevention and Control (IPPC) Licence is in the process of being prepared and it is planned to submit this to the Environmental Protection Agency (EPA) in November 2005. This Residuals Management Plan (RMP) is prepared in order to furnish the information required in Section K of the IPPC Licence Application, addressing the remediation, decommissioning, restoration and aftercare of the facility. This RMP is based on the EPAs (Draft) Guidance Documents and Assessment Tools on Environmental Liabilities Risk Assessment and Residuals Management Plans incorporating Financial Provision Assessment.

An initial screening and operational risk assessment of the facility indicated that the facility lies in the medium risk category. The risk assessment does not show any likelihood of significant residual liabilities.

2.2 Facility Closure Scenarios covered in this Plan Centocor has no current plans to decommission part or all of the site. Two possible scenarios in the event of a shutdown of the facility were considered.

~

0 Do-Nothing

0 Do-Something

The do-nothing scenario describes the situation of potential risks if the facility was vacated without implementing the residuals management plan. The do-something scenario describes the potential risks if the plan was implemented.

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It should be noted that a do-nothing scenario is not consistent with the divestiture policy of Johnson & Johnson, and hence Centocor. Consequently, Centocor propose to implement the do-something scenario, i.e. implement the RMP.

The scope of this plan addresses the key issues, which would occur in an orderly shutdown of all the site activities on a phased basis over an estimated time period of 3-6 months. The basis of the plan is to ensure that, upon completion of the plan, the facility would be in a suitable state for future industrial use and its condition would not pose a risk to public health and safety or the environment.

It is not intended to remove all structures or systems from the site. In general, specialist equipment will be distributed to sister plants in the event of a shut down.

Centocor intends to utilise existing staff resources to form a team to manage and execute the plan, supplemented where appropriate by outside resources. This Residuals Management Team would be responsible for managing and executing the complete plan. Outside contractors required for cleaning, waste disposal, incineration or recycling activities would be fully approved and licensed.

It is estimated that the duration of decommissioning and decontamination would be 3 to 6 months. Environmental monitoring would continue while the plan is in operation and for a period following the completion of the plan to be determined by the EPA and/or local authority. The EPA and the local authority would be informed of the results of the monitoring programme and of the status of the plan.

3.

3. I

Q

SITE EVALUATION

Facility Description and History The site of the Centocor Biomedicines Facility in Barnahely is a greenfield site located 0.5km west of Ringaskiddy village, 0.9km east of Shanbally village and approximately 8 Km south-east of Cork City. The site consists of a 12 ha zone located in the southeast corner of a 50 ha greenfield site. The site is in an elevated position compared with much of the surrounding landscape and industry with elevations in the range of 30m to 55m high and forms part of a secondary ridgeline in the area. Prior to the commencement of construction in July 2005, the landbank was used as pasture grassland with no evidence of any use other than agricultural. Land use in the immediate vicinity is largely industrial in nature. The N28 runs along the entire northern boundary of the site. To the west, the Centocor site is immediately adjoined by agricultural lands where ribbon housing extends south from Shanbally cross-roads adjoining this land. The existing Novartis plant and an ESB substation are located to the south of the site.

The site is zoned in the 2003 Cork County Development Plan (CDP) as “suitable for large stand-alone industry with suitable provision for landscaping and access points” . The nearest residences (sensitive receptors) are concentrated in the villages of Ringaskiddy to the east and Shanbally to the west. The EIS determined that the development will not have any significant adverse impacts with respect to human health, socio-economic factors, land use, or the amenity value and tourism potential of the area.

The closest designated areas to the site include:

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Centocor Biologics (Ireland) Ltd 101050-22-RP-0017 Residuals Management Plan 26" October 2005

0 Lough Beg, located 0.8 km south east of the site, is a proposed Natural Heritage Area (NHA) (Duchas Site Code - pNHA 1066) and is one of a number of ornithological sites around Cork Harbour;

Monkstown Creek, located 0.6 km north of the site, is a proposed Natural Heritage Area (pNHA) - (Duchas Site Code - pNHA 1979) within the Cork Harbour Special Protection Area (SPA).

There will be no significant environmental emissions from the facility which could give rise to adverse effects in these designated sites.

0

Site reference condition The site is being occupied as a part of an industrial development, planned and dedicated for commercial use. The reference condition of the site is therefore taken to be that of a clean site with utilities available with no historical pollution that has been generated on site. The objective of the residuals management plan will therefore be the return of the land to clean condition as a commercial site, not as a residential site, agricultural, nor as undeveloped land. Depositions on the site from offsite activities which may be present will not be within the scope of the residuals management plan.

3.3 Facility Compliance Status As this will be a newly-built facility, there are no issues of non-compliance associated with it.

3.4 Facility Processes and Activities The new facility in Ringaskiddy will be capable of manufacturing a range of Centocor products including :

0 CNTO 148 - The next generation of Centocor's primary product Remicade. Remicade is a drug for the treatment of Rheumatoid Arthritis, Crohn's Disease and Psoriasis

fl CNTO 1275 - For the treatment of Psoriasis and Multiple Sclerosis

0 A number of other products for Oncology and Auto-immune diseases, which are at the early stages of development

These antibodies andlor therapeutic proteins are derived from mammalian cell culture. The facility is designed specifically for concentrated CNTO 148 with the capability/flexibility to process non-concentrated CNTO 1275.

Overview of Production Process

The production steps include using a recombinant cell culture expression system at the 1,000 litre fermentation scale (three reactors), and a subsequent purification process to produce a formulated bulk. Each of the two biologically-derived bulk products are intended for manufacture at this site and will be internationally distributed to sterile fill/finish sites for conversion into final drug products. Currently, CNTO 1275 and CNTO 148 are in clinical trials.

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Centocor Biologics (Ireland) Ltd 101050-22-RP-0017 Residuals Management Plan 26’h October 2005

The manufacturing process is an aqueous-based non-flammable process, except for the use of a 20% denatured ethanol solution which is used as a column preservative and storage solution. An ethanol make-up facility is provided in the warehouse for making up the 20% solution.

There is the possibility that the products will be manufactured in campaign operation, that is, only one biopharmaceutical will be produced at a time and suitable cleaning procedures will be used between campaigns of different products.

3.5

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The production area of the facility is designed to process material from a working cell bank through to Formulated Bulk product operating 7 days/week, 24 hours/day in all plant areas. The basic process is shown in diagram form in Figure D.1.4.1 of the IPPC Licence Application. The facility is designed specifically for concentrated CNTO 148 with the capability/flexibility to process non-concentrated CNTO 1275. The total annual Formulated Bulk output will be approximately 180 kg based on manufacturing a single product. The facility output will be reduced if more than one product is campaigned. The process itself is not a sterile process, however, many process steps will be executed “as clean as possible”.

Inventory of Site Buildings, Plant, Raw Materials and Wastes

Description of the Plant

The Centocor Biomedicines Facility will include four main buildings, which will be connected by a link corridor (spine) to make up one continuous operation. It will be built in a single phase within the 12 hectare parcel and will include 24,391 m2 of b u i Id i ng s floor space . The layout of the proposed facility, occupying a development area of 12 hectares on the eastern side of the 50 ha site, is shown in Figure D.1.2 (Site Plan) and in more detail in Figure D.1.3 (Facility Layout Plan) in the IPPC Licence Application. The four buildings are:

Production Building -this building will consist of 2 floors for production, each 9m high, and a top floor to serve as the mechanical plant room which will be approximately 9m including parapet.

Central Utilities Plant (CUP) - this plant will house primary utilities (steam, chilled water, electrical power, compressed air, gases) and clean utility generation (e.g., purified water, water-for-injection, clean steam) for the facility.

Administration and Laboratory Buildiqg - this is a four-storey building, with offices, administration and cafeteria on the first and second floor, QA and QC laboratories on the third floor and a mechanical plant room on the fourth floor.

Warehouse - a central warehouse is located south of the CUP which is designed to hold approximately 800 ambient pallet storage spaces stacked 5 pallets high.

The spine corridor acts as a conduit for all services between the buildings.

Supporting site infrastructure and ancillary facilities includes a utility yard, 2 no. fire fighting water storage tanks and associated pump house, wastewater treatment plant (WWTP), surface water retention pond, underground services, an above ground installation (AGI), roads and car parking.

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Centocor Biologics (Ireland) Ltd Residuals Manaaement Plan

101050-22-RP-0017 26th October 2005

A detailed description of the production process and all unit operations is given in Section D of the IPPC Licence Application.

Design Considerations

The facility will be designed to satisfy US and European regulatory agencies for multi-product facilities under current good manufacturing practices (cGMP). The design takes into account the FDA, EMEA guidelines and the Johnson & Johnson Corporate guidance on biopharmaceutical manufacturing processes and equipment in licensed facilities.

The Centocor facility will be designed for antibody production using recombinant mammalian cell lines to meet European Directive 2000/54/EC Biohazard Classification: Group 1 Biological Agent requirements. The facility will also be designed for Contained Use of Genetically Modified Microorganisms (GMM), and under European Directive 98/81/EC the cells and proteins are classified as the lowest risk category of Class 1 microorganisms (i.e. those that present no or negligible risk).

Stock Inventory, Raw Materials Information

A complete list of the raw and ancillary materials, substances, preparations, fuels and energy which will be produced by or utilised in the activity is given in Section G of the IPPC Licence Application and its Attachment(s).

Hazardous Materials

Two chemicals that will be used in Production have been identified as requiring special handling precautions and greater levels of protection than elsewhere on site; these are Guanidine HCI and Mycophenolic Acid. The relevant operations and equipment have been designed to minimise personnel exposure. Quantities of ethanol (up to 1,000L) will be stored in the Warehouse.

4. CLOSURE CONSIDERATIONS

4.1 General In the event of closure of any Johnson & Johnson facility, the J&J Facility Deactivation Guide specifies a set of checklists to be completed, which cover such aspects as environment, quality and compliance, safety and industrial hygiene, sterilisation, and loss prevention.

@

4.2 Clean or Non-Clean Closure Declaration Upon cessation of operations and subsequent decommissioning at the facility, it is anticipated that there will be no remaining environmental liabilities, i.e. clean closure is expected.

4.3 Plant or Equipment Decontamination Requirements Decontamination of process equipment is a normal part of the Centocor operations, in accordance with the controlled manufacture of biological materials. Equipment requiring decontamination is foreseen to consist of process equipment used with chemical or biological materials. In addition to process equipment, decontamination

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Centocor Biologics (Ireland) Ltd 101 050-22-RP-0017 Residuals Manaaement Plan 26th October 2005

will be extended to any demolitions to be undertaken, and to the vacant areas created by such demolitions.

Decontamination will extend to the wastewater treatment plant vessels, all drains and sewers, to guarantee that all sludge and residues are removed from the site and are appropriately disposed of.

The decontamination programme will be based on updated risk assessment and will be submitted to the EPA for approval.

4.4 Plant Disposal or Recovery The process equipment will be decontaminated in accordance with normal operating procedures ensuring removal of all traces of chemical or biological material that could cause harm. Plant may be removed for use at other locations, left in place as part of the asset to be disposed of, or scrapped, based on risk assessment and cost benefit analysis.

Utility plant will be left with the asset, as mothballed equipment or ready-to-operate, depending on the best economic option.

4.5 Waste Disposal or Recovery Wastes to be managed in the circumstances of closure of the facility may include any or all of the wastes listed in Section H of the IPPC licence application. Wastes which may present for management over and above the normal range or volumes are foreseen as the following:

0 Scrapped decontaminated equipment;

0

Sludge from the wastewater treatment plant and associated drains;

Ducting and decontaminated process equipment

Residues of process and laboratory chemicals:

A

4.6

0 Non-hazardous waste arising from the disposal of residual packaging documentation, and waste arising from the cleaning of offices, workshops and welfare facilities.

The disposal of these wastes will be according to the current good practice as applicable to hazardous and non-hazardous waste, through licensed operators.

Soil or Spoil Removal Given the following:

0

0

The quantities of materials stored and used on site will be relatively small;

As the process is mainly water-based, the natures of the materials held onsite are generally not harmful to the environment;

The site will be concreted; 0

0 Materials will be stored in the Warehouse or in small or large volume storage tanks in the Utilities PlantNard or WWTP;

Process and foul effluent will be collected and treated on site;

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0 Surface water will be collected and analysed by TOC before release to the IDA sewer;

it is anticipated that there will be no contaminated ground, soil or spoil arising at the site that would require specialist recovery or disposal.

IMPLEMENTATION OF RESIDUALS MANAGEMENT PLAN

Particular actions are listed below for specific areas of the facility as part of the Residuals Management Plan. In general, care and attention will be given during the implementation of the plan to ensure that the potential risks associated with the plan are avoided. In the event of a spillage, leak or fire during decommissioning, Centocor’s Emergency Plan would be fully implemented in order to minimise the risk to health and the environment.

5.

5. I Production Areas

@ The RMP for all production areas would consist of the following actions:

0 Cessation of all production other than completion of work in progress.

Removal of all products to the relevant area of the warehouse for transfer to ~

other facilities or for disposal if necessary.

Cleaning and decontamination of all process vessels and any other equipment with product contact. Site cleaning procedures, using clean-in- place, steam-in-place, clean-out-of-place, steam-out-of-place and the autoclave would be sufficient for these operations. Additional specific procedures would be developed, if required. The state of cleanliness would be verified either analytically or through a visual inspection.

Cleaning and decontamination of any ducting or enclosure that would have product or other material contact.

Cleaning and decontamination of the autoclave.

Shutting of all supply lines to the buildings, cleaning out all pipework through regular cleaning methods.

Shutting off unnecessary services to the building. Heating and ventilation capability would be maintained.

Maintenance of key instrumentation and computer systems required for ongoing monitoring of the status of the equipment, the remaining instrumentation to be disconnected and rendered safe.

Cleaning and decontamination of all floor drains and sumps.

Specialist equipment, once decontaminated, to be sent to a sister Centocor facility for use in similar or other processes. This would probably include the removal of the four reactors and twenty-four media harvest tanks.

0

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0

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5.2 J1 lities The RMP for the utilities areas would consist of shutting down of the following systems on a phased basis, depending on plant status and requirements:

Boilers

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Centocor Biologics (Ireland) Ltd 101050-22-RP-0017 Residuals Manaaement Plan 26th October 2005

It is likely that only one of the two boilers would be required during decommissioning and subsequently for ongoing heating requirements. The remaining unit would be shut down and disconnected from the steam distribution system. The boilers would be cleared of residues and the fuel lines cleaned and blanked off. Condensate systems would be drained and cleaned and left in a safe state.

Compressed Gases

These units would be shut down and disconnected at an appropriate time. The gas storage tanks in the Utility Yard (oxygen, carbon dioxide and nitrogen) would be emptied and returned to the distributor.

Removal of any associated chemicals, oils or any other materials used in the utilities area for redistribution, return to vendor or disposal, if required.

The water supply system would be maintained due to the needs for fire protection and sanitary services.

Waste Oils, Diesel and Hazardous Waste

Waste oils, diesel and hazardous waste used in the utilities area will be sent for suitable treatment or disposal. Hazardous waste will be removed from site and disposed of to a suitably licensed facility.

Maintenance and Engineering 0 The secure archiving of all engineering documentation including drawings,

process and instrumentation diagrams, validation documentation, vendor manuals and data, project files, maintenance records, inspection records and all other appropriate documentation.

Disconnection of all maintenance equipment to leave it in a secure state. Distribution of equipment to a sister C'entocor facility or sale to interested party, where possible.

0 Removal of all old and obsolete equipment from maintenance areas, workshop areas and stores for recycling or disposal by a licensed contractor.

0

5.3 Offices, Administration, Reception and Security The RMP for the offices, Administration areas, Reception and Security would include the following actions:

Removal of administration equipment for distribution to sister facility or sale to interested party, where possible, otherwise for disposal by a licensed contractor.

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0 The maintenance of a security presence on site on a 24-hour basis for ongoing monitoring of the site from a safety, fire prevention and environmental perspective.

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Centocor Biologics (Ireland) Ltd Residuals Manaaernent Plan

101 050-22-RP-0017 Y 26th October 2005

5.4 Laboratory Areas The RMP for laboratory areas would consist of the following actions:

Completion of all necessary analytical work on production in progress and all final products before removal from site.

Return to vendor or sell on all unopened and in-date laboratory chemicals

Removal of all opened chemical containers and out-of-date chemicals for recycling or for disposal by a licensed contractor.

Cleaning and decontamination of laboratory instruments

Cleaning and decontamination of all glassware, storage areas, waste systems and any other equipment or systems.

Shutting down of all computer systems other than those deemed necessary for ongoing monitoring of the area.

Transfer of specialised equipment to sister plant or sale to similar facility. Recycle of obsolete equipment, if possible, otherwise disposal by licensed contract or.

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5.5 Canteen and Kitchen Removal of canteen equipment for distribution to sister facility or sale to interested party, where possible, otherwise for disposal by a licensed contractor.

5.6 Wastewater Treatment Plant The wastewater treatment plant would be shutdown and disconnected at the appropriate time. The contents of the WWTP, which could amount to 200-300m3 of activated sludge, would require removal and treatmenudewatering at a suitably licensed facility. The plant and associated pipework would be cleaned and decontaminated through normal cleaning methods.

5.7 Warehouse The RMP for the warehouse would consist of the following actions:

Cancellation of all orders for incoming materials to the site;

Negotiate with sister plants with a view to distribution of unused materials;

Negotiation with relevant suppliers to return unused materials to supplier;

0 Send opened containers and unreturnable or out-of-date goods for appropriate treatment or disposal;

Clean and decontaminate the storage areas. Specific procedures would be developed, if required. The state of cleanliness would be verified either analytically or through a visual inspection.

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5.8 IPPC Licence Documentation

All IPPC related documentation will be maintained on file at a designated location for a minimum of 7 years post closure of the facility. Where a transfer of the IPPC Licence takes place, the associated IPPC documentation will reside with the new Licensee.

5.9 Other Areas The following other actions would be required to ensure the implementation of the RMP on a site-wide basis:

n

e Cessation of any construction project work on site so that the site is left in a safe and orderly condition. Contractors will be required to decommission any construction compounds and remove all construction equipment, construction materials and waste, storage units and temporary offices from the site at the completion of construction projects.

Disbandment of contract personnel, facilities and equipment.

Termination of all non-essential maintenance and other contracts.

Removal from site any temporary offices or storage areas.

Continuation of ongoing monitoring programmes to insure the integrity of the groundwater and surface waters on site.

Rationalisation of the site electricity supply. This would involve removing transformers from service, allowing remaining site operations to run from one transformer. Oils would be removed from redundant transformers.

Testing of soils and groundwater at the time of decommissioning would be performed and remediation carried out, if necessary.

Retention of all necessary fire alarms and fire protection systems.

Retention of standard security patrols, video monitoring and defined site access procedures.

Cleaning of all petrol/oil interceptors as per normal procedure.

Removal of all items that may contain mercury (for example fluorescent lights) or any other controlled compounds for recycling or disposal if necessary.

6. CRITERIA FOR SUCCESSFUL CLOSURE

Successful clean closure will be expected to be achieved when it can be demonstrated that there are no remaining environmental liabilities at the site. In practice this will require demonstration that the following criteria have been met:

All plant was safely decontaminated using standard procedures and authorised contractors;

All wastes were handled, packaged, temporarily stored and disposed of or recovered in a manner which complies with regulatory requirements;

All relevant records relating to waste and materials movement and transfer or disposal were managed and retained throughout the closure process;

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7. I

There was no soil or groundwater contamination at the site. This was verified using monitoring data and a soil/groundwater assessment at the time of closure (if required);

The Environmental Management System remained in place and was actively implemented during the closure period;

The asset is suitable for use as a commercial development site, as demonstrated by an environmental due diligence assessment. As part of the Johnson & Johnson Sustainability Practices Environmental Planning Policy, it is Centocor’s responsibility to ensure that any business transaction involving the divestiture of a facility should be preceded by an environmental due diligence to assess and quantify potential environmental liabilities associated with the transaction. This due diligence must contain a summary and a detailed explanation of the following issues:

o Environmental liabilities, past and present;

o Regulatory non-compliance issues along with a ranking of their severity @ and implications;

o Potential limitations on business expansion and business interruption potential;

o Major environmental risks;

o Approximate cost estimate to bring closure to these issues.

A copy of the environmental due diligence report must be submitted to J&J Worldwide Environmental Affairs. The decision on clean-up condition will be reflected in the agreement of sale.

CLOSURE PLAN COSTING

Decommissioning Costs The costs associated with decommissioning are generally related to the disposal and recycling of equipment and the use of external resources to implement the RMP. In certain instances, costs will be recouped through the sale of equipment or materials. The liabilities risk assessment does not foresee any ongoing monitoring requirements.

It is expected that external resources will be required in order to implement the RMP in full. A list of these resources and associated costs (at 2005 prices) is shown in Table 1 below.

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Centocor Biologics (Ireland) 1 1 101050-22-RP-0017 Residuals Management Plan 26'h October 2005

Table 1: Decommissioning Costs

Item Transportation of reactors, harvest tanks, laboratory equipment to another Centocor facility Waste treatment/disposal costs Contract cleaning and decontamination Civil and structural, mechanical, electrical and instrumentation contractors (20,000 manhours at €50/hr)

professional cons u I ta n cy Subtotal Contingency (25%) Total

Environmental Due Diligence Audit by

Estimated Cost (€) 50,000

10,000 70,000

1,000,000

100,000

1,230,000 310,000

1,540,000

The processes and operations at the facility do not give rise to any reasonable probability that site remediation in the form of groundwater or soil cleanup would be a likely requirement.

The site would be left in a clean condition, i.e. decontaminated and certified as being free of any biological or chemical hazard. All buildings would be retained. All bulk materials and process intermediates and products would be removed.

No liabilities would be incurred due to activities of contractors storing and disposing of materials removed from the Centocor site, as Centocor will continue to apply its current waste management principles.

No civil liability would be incurred as a result of third parties alleging environmental damage arising from the operational phase or closure.

The maximum asset value of the facility would be maintained, but no action would be taken to prepare the site for a trade sale as a going concern or otherwise.

Normal practice would be applied to minimise ongoing liabilities and to fulfil insurance requirements.

It is assumed that the planning authority would not take any action to prevent site dereliction, as the existing facilities would be maintained in a condition suitable for future beneficial use. The planning authority will be notified of the plans to decommission and will be consulted in relation to the isolation of facilities and services on site.

In addition, no factors have been identified that would indicate an unusual liability for the site in comparison with other process industry sites.

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I

7.2 Facility Security and Staffing A number of staff members would be required to remain on site for a period of 3-6 months to successfully implement the Residuals Management Plan. These are estimated as follows:

7.3

7.4

8.

8.1

Management 2 Security 4 Laboratory 3 Administration 2 Other staff 5

The total cost of continuing to employ these staff members is expected to be in the region of €500,000.

On completion of the clearance of the site, the asset will be sold; pending sale the site will be supervised by Security. Depending on the commercial arrangements appropriate at the time, this responsibility may by undertaken by a liquidator. The cost of this supervision is likely to be no more than €100,000 at 2005 prices.

Total Cost c

The total cost associated with executing a Residuals Management Plan at the Centocor site is estimated to be in the region of E2.14m.

Funding of Residuals Management Plan Centocor, a subsidiary of the Johnson & Johnson Corporation, confirms that the company has more than adequate resources from operations to fund the Residuals Management Plan as set out above.

Further details on the financial status of Johnson & Johnson can be found in the 2004 Annual Report available via the following web link:

http://www.ini.com/communitv/pu blications/index. htm

In addition, the value of the facility itself as a fixed asset worth approximately E300m will far outweigh any remediation cost.

CLOSURE PLAN UPDATE AND REVIEW

Proposed Frequency of Review The RMP will be reviewed annually and submitted to the EPA as part of the site’s Annual Environmental Report.

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http://www.ini.com/communitv/pu


8.2

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9.

9.1

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10.1

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Proposed Scope of Review The scope of the annual review of the RMP will cover the following at a minimum:

Review in accordance with the facility’s IPPC Licence conditions;

Review any incidents that may result in soil contamination;

Review changes in underground structures;

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Review scope of decontamination.

CLOSURE PLAN IMPLEMENTATION

Statutory Authority Notifications The EPA and local authority will be notified of Centocor’s intentions to full or partially decommission the facility.

Full or Partial Closure Considerations Any partial closure of the facility will be dealt with as a change of activity, as long as the licensable activity remains on the site.

CLOSURE PLAN VALIDATION

Closure Validation Audit A typical condition of an IPPC licence is that “a final validation report to include a certificate of completion for the residuals management plan, for all or part of the site, as necessary, shall be submitted to the Agency within three months of execution of the plan”. In addition, the licensee (Centocor) shall “carry out such tests, investigations or submit certification, as requested by the Agency, to confirm that there is no continuing risk to the environment.”

As stated above, the Johnson & Johnson (J&J) Sustainability Practices Environmental Planning Policy requires that Centocor ensures that any business transaction involving the divestiture of a facility should be preceded by an environmental due diligence audit to assess and quantify potential environmental liabilities associated with the transaction.

The scope of due diligence shall be based on the size and complexity of the subject transaction, facility, and the property. J&J Worldwide Environmental Affairs shall be contacted for assistance, when appropriate. The following measures shall be taken into account when executing the due diligence:

0 An environmental consulting firm approved by Worldwide Environmental Affairs shall be retained to conduct the due diligence under the direction of operating company management.

The due diligence shall follow a phased approach, designed to provide more in-depth information with each successive phase.

Ample time shall be allowed to complete all phases, including any required fieldwork and associated analytical testing.

Where required, the scope of environmental assessments shall comply with applicable standards, such as the ASTM Standard Practice for

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Environmental Assessments: Phase 1 Environmental Site Assessment Process. . .

In addition to assessing traditional environmental liabilities, the due diligence effort shall include the following elements:

Regulatory Compliance - given the time constraints in the due diligence process, the regulatory compliance review shall focus on major issues, rather than a detailed audit of the facility's compliance status. A search of regulatory agency records shall be performed to determine if enforcement or any other major regulatory actions are pending against the facility.

Limitations on Property and Operations Expansion - regulatory permits, zoning, and public infrastructure capacity shall be reviewed in an effort to gauge potential limitations in expansion of operations. This need not be an exhaustive, detailed review, rather an overview of existing conditions based on general information received from the facility and knowledge of external consultants assisting in the due diligence project.

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8 0 Major environmental risks.

A due diligence report shall be prepared which includes a summary and a detailed explanation of issues, grouped as follows:

0 Environmental liabilities, past and present

0 Regulatory non-compliance issues along with a ranking of their severity and implications

0 Potential limitations on business expansion and business interruption. potential

0 Major environmental risks

0 Approximate cost estimate to bring closure to these issues.

A copy of the due diligence report shall be submitted to J&J Worldwide Environmental Affairs.

Such an environmental due diligence audit is expected would take approximately 10-12 weeks to execute .and would cost in the region of €100,000 (2005 costs). @ Divestitures and Exiting Leases

When divesting of facilities or real estate properties, an environmental assessment shall be conducted to identify all environmental liabilities and establish a baseline report on the environmental conditions of the property at the time of transfer.'These conditions shall be documented and communicated to the purchaser representatives. A copy of the environmental assessment report shall be submitted to J&J Worldwide Environmental Affairs.

If environmental contamination is discovered, the decision to remediate conditions shall be agreed upon with the purchaser, in consultation with J&J Worldwide Environmental Affairs, and shall be reflected in the agreement of sale.

If long-term (greater than two years) environmental warranty is given to purchaser, the scope of environmental assessment shall be accordingly expanded to allow for

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@ Centocor Biologics (Ireland) Ltd 101050-22-RP-0017 Residuals Management Plan 26'h October 2005

the establishment of a much more comprehensive baseline. In these cases, at a minimum, sewer integrity testing shall be added to the scope of the environmental assessment, unless testing had been recently completed.

10.2 Closure Validation Audit Report For an IPPC licence to be transferred or surrendered, there must be a consultation process with the EPA. Normally, the EPA conducts a post-closure audit of the site and thereafter the EPA must be satisfied that the facility is fully compliant with its licence conditions at the time of closure in order to facilitate the formal surrender or transfer of a licence.

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