EPA Application FormPollution prevention measures may, inter alia, include the following...

Authorisation Application Form

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EPA Application Form

9.1 - Environmental Management Techniques -

Attachment

Organisation Name: Janssen Sciences Ireland UC

Application I.D.: LA001427

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Amendments to this Application Form Attachment

Version No. Date Amendment since previous version Reason

V.1.0 July 2017 N/A Online application form attachment

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9 Environmental Management Techniques 1

9.1. Accident Prevention Measures

Measures to prevent accidental emissions and liabilities

Incidents and accidents are unplanned events. Emissions from incidents and (major) accidents usually occur within a relatively short time frame but with greater intensity than under normal operating conditions. Incidents such as fire or fuel spillages can result in liabilities such as contaminated soil and groundwater. Proactive risk management reduces the potential for an incident.

Abnormal operating conditions must be managed without endangering human health and harming the environment, and in particular without risk to water, air, soil, plants or animals, without causing a nuisance through noise or odours, and without adversely affecting the countryside or places of special interest.

The applicant must firstly undertake a risk assessment in accordance with EPA guidance on assessing and costing environmental liabilities. Having identified the key risks, the applicant should populate the following table with the measures to be taken to treat the key risks, e.g., bunding, integrity testing, fire prevention, etc.

The range of measures is dependent on the complexity of the site. Pollution prevention measures may, inter alia, include the following information:

• Conclusions on BAT set out in the EU Reference document on BAT on emissions from storage such as a safety management system; corrosion prevention measures on tanks, etc.

• Details of storage of all raw materials, products and wastes such as segregation, labelling, designation and impervious surface;

• Details of spill or emergency containment measures and structures such as bunds, high level alarms, absorbent materials;

• Details of fire detection and fire-water retention facilities in the event of emergencies or other measures to contain fire-water;

• Details of transport of material within the site, solid, liquid or sludge transported by pipe, vehicle or conveyor; etc.,

• The Agency has published a guidance document on Fire-Water Retention Facilities and on the Storage and transfer of materials.

1 This part of the form collects information on environmental management at the installation/ facility. It seeks to understand the maturity of the management system

in terms of knowledge of abnormal operating conditions, prevention and early detection measures and emergency response procedures. The level of detail required in this part of form relates to the environmental risk posed.

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Describe in the table below existing and/or proposed measures, including emergency procedures, to minimise the impact on the environment of an accidental emission or spillage. (This table should include the measures to be taken under abnormal operating conditions, including start-up, shutdown, leaks, malfunctions, breakdowns and momentary stoppages that will demonstrate that any emission arising will not cause significant environmental pollution)2. The existing Janssen site has been in operation since 2006 in accordance with the requirements of the IE Licence (previously IPPC Licence) and has multiple measures in place to prevent accidental emissions and liabilities such as the measures listed below, all of these measures will apply to the BioCork2 expansion project. The existing and new processes associated with the expansion are water based and involve only limited use of flammable solvents. The facility is considered low hazard and it has been established that the Seveso III regulations are not applicable to Janssen operations. There have been no incidents or fires on site to-date since operations have commenced that have caused environmental harm. Whilst every effort is made to prevent the occurrence of emergency situations, the company has prepared emergency plans to deal with any emergency situation that may arise. These procedures and plans are in line with Janssen’s regulatory, corporate and social responsibilities.

Measure

Surveillance Measures

Description Frequency of Surveillance

Method / Standard

Emergency Response Plan (ERP)

The Emergency Response Team (ERP) details the initial response to an environmental, health or safety related incident on site, for example a fire, chemical spillage or gas leak. This plan describes the procedures for handling emergencies on the Janssen site and ensures environmental risks are contained and minimise any adverse impacts on the environment. Plant, processes and materials have been examined, through a process of risk assessment, and areas that may give rise to safety or environmental emergencies have been identified. Risk Assessments will also be conducted for the BioCork2 expansion and the ERP updated accordingly.

The emergency response system is tested by conducting evacuation drills and incident simulations in accordance with J&J requirements, and at least twice per year. Training is carried out regularly for all

The EHS Department are responsible for the recruitment and training of the Emergency Response Team (ERT) personnel. The ERP is reviewed annually and where there is a significant change in regulations, operations, processes, or raw material, or after the occurrence of accidents or emergency situation or after incident simulation.

2 Information relating to the integrity, impermeability and recent testing or pipes, tanks and bund areas should be included.

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Measure



Method / Standard

categories of staff regarding

the appropriate response required for emergency situations.

Chemical Awareness and Management Procedure

The existing Chemical Awareness and Management Procedure is designed to manage the following aspects of chemical substance control:

Chemical Hazard Communication

Chemical Risk Assessments

Chemical Inventory Database

Material Safety Data Sheets (MSDS’s)

Labelling

Purchase of Chemicals

Chemical compatibility, handling and storage

Polychlorinated Biphenyls (PCB’s)

Carcinogens

Contractors

Training

Initial and refresher training is provided to all employees in accordance with EHS Training Plan.

Chemical Awareness and Management Procedure is maintained and updated in accordance with Janssen’s regulatory, corporate and social responsibilities.

Chemical Risk Assessments All new chemicals or mixtures on site as well as previously used chemicals or mixtures used in a different process are assessed using Chemical Risk Assessment SOP (CBILSOP-HSE-0014).

Risk assessment carried out upon introduction on new chemicals to site.

Risk assessment conducted In accordance with Chemical Risk Assessment SOP.

Spillage Response and Management The facility has been designed to reduce the The frequency The EHS Department are

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Measure



Method / Standard

Procedure environmental impact of the company’s operations during normal, abnormal or emergency situations. Environmental aspects have been identified and assessed in order to minimise the effects of any emergency on the environment. The principle areas in which spills/leaks may occur are the Laboratory, Warehouse, CUP and Manufacturing areas. Spills or leaks may also occur in any other area of the plant during special operations (e.g. hot work etc.). Spills may be flammable, toxic, corrosive, combustible, and bio-hazardous or have other special hazards associated with them. Procedures for handling spills have been drawn up in procedure DS-SOP-4054 ‘Spillage Response and Management Procedure’. This procedure applies to the alerting of, responding to and clean-up of all spills at Janssen Sciences. The response to a spill also includes the recording of the spill as an incident and the investigation and corrective action process to minimize a spill incident reoccurring.

of the training is commensurate with the risks or whenever new equipment, materials or processes impact the initial risk assessment.

responsible for the implementation and management of spill response and are also responsible for the recruitment and training of the Emergency Response Team (ERT) personnel.

Employees potentially affected by minor spills are trained in the procedures to be implemented in the event of a spill or release of a hazardous substance or where a hazardous condition may arise from a spill event. Only employees who have received ERT training are permitted to deal with major spills.

Environmental Liability Risk Assessment (ELRA)

The ELRA was prepared to satisfy condition 12.2.3 of the IED licence and to accurately reflect the risks of unplanned but plausible incidents occurring including abnormal operating conditions. Details provided further on within this attachment.

The ELRA is reviewed as necessary to reflect any significant change on site, and in any case

The methodology for the development of the ELRA follows the EPA Guidance Document; Guidance on Assessing and Costing Environmental Liabilities (EPA 2014).

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Measure



Method / Standard

every three years following initial agreement; review results are notified as part of the AER.

Work Permit System Any site work completed by contractors requires a permit to work ensuring a risk assessment of the task is completed.

Per task Site Work Permit System

*add rows to the table as necessary

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Outline what provisions have been made to ensure an adequate response to emergency situations outside of normal working hours, i.e., during night-

time, weekends and holiday periods (attach additional pages to this document if required):

The site emergency response plan (ERP) defines the actions to be taken during normal operations and also outside working hours and when the plant is shutdown. Whilst the standard work day is typically 08:30 -17:00, production is based on 24hrs per day, 7 days per week, 365 days per year with continual shift staff

and security presence on site. There are at least four incident controllers on site at any one time and 5 Emergency Response Team (ERT) members.

Soil Monitoring Points

Periodic monitoring of soil and groundwater is required having regard to the possibility of soil and groundwater contamination of the site3.

Complete the table below with details of soil monitoring locations and in particular where a baseline report has been/is required in accordance with Section

86B of the EPA Act 1992 as amended.

Is periodic soil monitoring proposed at the installation/facility? (Yes/No): Yes

Soil Monitoring Point Code Monitoring Point Grid Ref.

Easting 4 Northing 5

Representative soil monitoring locations to be agreed with the EPA in advance of monitoring, on the basis of the Baseline Report (Attachment 4-8-3)

3 Inherent in the monitoring of soil and groundwater is accepting the possible necessity for remediation of the soil / groundwater. Regular monitoring of soil and groundwater provides an early detection of any contaminations. 4 Six Digit GPS Irish National Grid Reference

5 Six Digit GPS Irish National Grid Reference

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Soil Monitoring Point Code Monitoring Point Grid Ref.



Soil Parameters Complete the table below with details of soil monitoring parameters (where a baseline report is required in accordance with Section 86B of the EPA Act 1992 as amended). (If different parameters are associated with different monitoring points this should also be identified in the table below.)

Parameter Unit Trigger Level

How was the trigger level determined?

Proposed Monitoring Frequency

Sample Method Analysis Method / Technique

Total Petroleum Hydrocarbons (TPH) (speciated)

Trigger levels to be agreed with the EPA in advance of proposed monitoring

Every 10 years after grant of licence

To be agreed with EPA



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Groundwater Monitoring Points Based on the assessment(s) carried out previously or as part of this licence application, complete the table below with summary details of the groundwater monitoring points.

Is groundwater monitoring proposed at the installation/facility? (Yes/No): Yes

Monitoring Point Code Monitoring Point Grid Ref.


AGW05 (Note 1) 176635 64264

AGW02 176989 64391

AGW03 177072 64060

AGW04 177240 64283


NOTES:

1. Groundwater monitoring well AGW01 was decommissioned to facilitate the BioCork 2 expansion and replaced with monitoring well AGW05 (approved

under Licensee Return LR028572)



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Groundwater Parameters

Complete the table below with summary details of the groundwater parameters. (If different parameters are associated with different monitoring points this should be identified in the table below.)


How was the trigger level determined? (Refer to Notes 2 to 4)



pH pH units

Outside range 6.5 to

9.5

EPA IGV, Drinking Water (DW) Regulations

Biannually Sampling in accordance with best practice BS ISO 5667-11:2009 “Water Quality. Sampling. Guidance on sampling of groundwaters” (or similar)

Analysis carried out at an accredited laboratory

Conductivity µS/cm @ 25°C

1,875 Groundwater (GW) Regulations Biannually As above As above

COD mg/l n/a n/a Biannually As above As above

TOC mg/l Abnormal change

EPA IGV Biannually As above As above

Temperature °C n/a n/a Biannually As above As above

Calcium mg/l 200 EPA IGV Biannually As above As above

Magnesium mg/l 50 EPA IGV Biannually As above As above

Potassium mg/l 5 EPA IGV Biannually As above As above

Sodium mg/l 150 EPA IGV, GW Regulations Biannually As above As above

Sulphate mg/l 187.5 GW Regulations Biannually As above As above

Chloride mg/l 187.5 GW Regulations Biannually As above As above

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How was the trigger level determined? (Refer to Notes 2 to 4)



Nitrate mg/l 37.5 GW Regulations Biannually As above As above

Nitrite mg/l 0.375 GW Regulations Biannually As above As above

Total Cations mmolc/l

n/a n/a Biannually As above As above

Total Anions mmolc/l

n/a n/a Biannually As above As above

Ammonium mg/l N 0.175 GW Regulations Biannually As above As above

Total Nitrogen mg/l n/a n/a Biannually As above As above

Volatile Organic Carbons (VOCs) - NOTE 5 NOTE5 Biannually As above As above

Semi-volatile Organic Carbons (SVOCs) - NOTE 5 NOTE5 Biannually As above As above

DRO/GRO/BTEX/MTBE to include Mineral Oil

mg/l 0.01 EPA IGV Biannually As above As above


NOTES:

2. EPA IGV = Trigger value for this parameter was determined from EPA Interim Guideline Value (Reference: EPA (2013). “Towards Setting Guideline Values for the Protection of Groundwater in Ireland – Interim Report”)

3. GW Regulations = Trigger value for this parameter was determined from Schedule 5 of the European Union Environmental Objectives (Groundwater) Regulations 2010, as amended (S.I. 9 of 2010)

4. DW Regulations = Trigger value for this parameter was determined from parametric values listed in Schedule – Part 1 of European Union (Drinking Water) Regulations 2014 (S.I. 122 of 2014)

5. The trigger levels for VOCs or SVOCs will be abnormal change or the threshold values indicated for specific compounds by EPA IGV, GW Regulations, or DW Regulations

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Costed Environmental Liabilities Risk Assessment (ELRA) Indicate if the activity, through pre-application meeting with the Agency or other means, is required to submit a costed ELRA8 as part of the licence, or licence review application.

Costed Environmental Liabilities Risk Assessment (ELRA) required to be submitted? (Yes/No): Yes

If ‘Yes’, upload a costed Environmental Liabilities Risk Assessment (ELRA), prepared in accordance with the Environmental Protection Agency’s Guidance on Assessing and Costing Environmental Liabilities (2014) (select Document Type: ‘ELRA’ in the application form).

Costed ELRA document filename: Attachment-9-2-1-ELRA-Nov-2016

Indicate your preferred form of financial provision instrument to meet ELRA costings have regard to the Environmental Protection Agency’s Guidance on Financial Provision (2015), e.g., Environmental Liability Insurance:

To be agreed with the EPA

Upload a financial provision proposal have regard to the Environmental Protection Agency’s Guidance on Financial Provision (2015) (where required at application /review application stage) (select Document Type: ‘Financial Provision Proposal’ in the application form)

Financial Provision Proposal filename: NA

8 There is an explicit requirement in EU and Irish law for financial provision for certain activities. The following categories of activities have an ELRA/CRAMP/FP

requirement: 1. Landfills (excl. closed L.A. Landfills closed before 16

th July 2009)

2. CAT A Extractive Waste Facilities 3. High Risk Contaminated Land Facilities 4. All Haz-Waste Transfer Stations 5. Non-Haz WTS (Accepting >50,000 tons/annum) 6. Incineration (incl. co-incineration of hazardous waste) 7. Upper & Lower Tier Seveso Sites 8. Exceptional circumstances associated with the site, e.g., significant ground/groundwater contamination. Regard should be had by applicants to relevant Agency guidance on these matters.

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Closure, Restoration and Aftercare Management Plan (CRAMP) A restoration/aftercare period will be required where there are on-going environmental liabilities following closure. Applicants are required to describe the existing or proposed measures to avoid any risk of environmental pollution and to return the site to a satisfactory state or the state established in the baseline report where applicable, after the activity or part of the activity ceases operation. A key measure is the preparation of a Closure, Restoration and Aftercare Management Plan (CRAMP) by the operator, for certain activities9. Notwithstanding the requirements of the EC Environmental Objectives (Groundwater) Regulations 2010, S.I. No. 9 of 2010, the closure and restoration/ aftercare target is the site condition at the time of the original application or the baseline report. The applicant shall have regard to the Environmental Protection Agency’s Guidance on Assessing and Costing Environmental Liabilities (2014) in the preparation of the CRAMP.

Upload a CRAMP, where applicable (select Document Type: ‘Site Closure’ in the application form).

CRAMP filename: Attachment-9-2-3-Site Closure-Nov-2016

Costed CRAMP Indicate if the activity, through pre-application meeting with the Agency or other means, is required to have a CRAMP 9 submitted as part of the licence, or licence review application.

CRAMP required to be submitted at application/licence review application stage? (Yes/No): Yes

9

There is an explicit requirement in EU and Irish law for financial provision for certain activities. The applicant shall have regard to the Environmental Protection Agency’s Guidance in determining CRAMP requirements and on Financial Provision (2015) in making financial provision to cover any liabilities.

The following categories of activities have an ELRA/CRAMP/FP requirement:

1. Landfills (excl. closed L.A. Landfills closed before 16th

July 2009) 2. CAT A Extractive Waste Facilities 3. High Risk Contaminated Land Facilities 4. All Haz-Waste Transfer Stations 5. Non-Haz WTS (Accepting >50,000 tons/annum) 6. Incineration (incl. co-incineration of hazardous waste) 7. Upper & Lower Tier Seveso Sites 8. Exceptional circumstances associated with the site e.g. significant ground/groundwater contamination.

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Indicate your preferred form of financial provision instrument to meet CRAMP costings (where appropriate), e.g., Secured fund, On-demand performance Bond, Parent Company Guarantee, Charge on Property (have regard to the Environmental Protection Agency’s Guidance on Financial Provision (2015) on the Agency’s website):

State preferred form of financial provision instrument? To be agreed with EPA

Upload a financial provision proposal (where required) having regard to the Environmental Protection Agency’s Guidance on Financial Provision (2015) in making financial provision to cover any liabilities (select Document Type: ‘Financial Provision Proposal’ in the application form)

Financial Provision Proposal filename: NA

Cessation of Activity

Where a CRAMP is not required, describe the measures to be taken on and following the permanent cessation of the activity or part of the activity to avoid any risk of environmental pollution and to return the site of the activity to a satisfactory state. (Input your response in the text box below or attach the information in to this attachment).

NA

Emergency Response Procedure

Do you have an emergency response procedure (ERP)? (Yes/No) Yes

Is the ERP compliant with the EPA guidance? (Yes/No) Yes

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9.2. Nuisance

Complete the table below in relation to each potential nuisance. Identify if the activity may cause or contribute to the type of nuisance in the area of the installation/facility and, where applicable, identify the techniques used to prevent/minimise the nuisance.

Type of Nuisance

Applicable to the activity?

(Yes/No/ Not Applicable)

Techniques to prevent nuisances Where nuisances cannot be prevented, techniques to be used

to minimise and reduce nuisances

Odour Yes Applicable to the WWTP only – odour abatement system

Fire Control Yes Comprehensive fire suppression system on site

Dust Yes Dust abatement on lime dosing system for WWTP

Litter NA

Birds NA

Mud NA

Flies NA

Vermin NA Whilst NA there is a vermin control programme in place on site.

Other NA

If ‘Other’ is selected define the other nuisance(s): NA

Note: Odour must also be addressed in the fugitive emissions section of the ‘7.4 Emissions to Atmosphere – Main and Fugitive’ template, where applicable.

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9.3. Environmental Management System (EMS)

Do you have an environmental management system? (Yes/No) Yes

If ‘Yes’, is the environmental management system accredited? (Yes/No) Yes

State the date accreditation was achieved or is expected to be achieved, where applicable:

Initial date 2011, reissue date Dec 2016

State the standard of accreditation achieved: ISO14001

Energy Efficiency

Outline the measures taken to ensure that energy is used efficiently having regard to the relevant decision on BAT conclusions and/or BAT guidance and where appropriate, an energy audit with reference to the EPA Guidance document on Energy Audit should be carried out.

The design of the expansion has been developed to adopt a design that is highly energy efficient. The existing site 3MW wind turbine will contribute onsite renewable energy in order to offset high process energy requirements. The current maximum electrical demand is approximately 1.6 MW. The new expansion works planned under the BioCork2 expansion will utilise the excess energy that is currently being produced by the wind turbine and this will also be used as part of the criteria to achieve LEED certification. An Energy Review was completed for the expansion project with the following outcomes: - The intent of the project is to achieve LEED (US Green Building Council’s Leadership in Energy and Environmental Design) certified status as required by the Policy for the Sustainable Design and Construction of Johnson & Johnson Facilities. - An Energy savings Register was completed during the preliminary design phase with a list of Energy Conservation Measures (ECMs) with payback less than 10 years to be further considered as part of the Detailed Design. Energy efficient measures will include: - High performance building envelope - High efficient HVAC plant and lighting design A rainwater harvesting system will be implemented to reduce potable water

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demand for domestic water consumption by > 50% with a 100% usage for sewage conveyance.

Has an energy audit been carried out? (Yes/No) The Janssen facility undergoes regular site audits of energy consumption as part of the ISO 50001 compliance programme which are in-line with the Best Available Techniques (BAT) for Energy Efficiency.

Do you have an energy efficiency management system? (Yes/No) Yes

If ‘Yes’, is the energy efficiency management system accredited? (Yes/No) Yes

State the date accreditation was achieved or is expected to be achieved, where applicable:

8th September 2017

State the standard of accreditation achieved: ISO 50001:2011 (Energy Management Systems)

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9.4. Hours of Operation Provide details of the hours of operation for the installation (hours and days per week, etc.), including:

(a) Proposed hours of operation. Whilst the standard work day is typically 08:30 -17:00, production is based on 24hrs per day, 7 days per week, 365 days per year with continual shift staff and security presence on site.

(b) Proposed hours of construction and development works and timeframes. The BioCork2 expansion will entail a 24 month construction period, commencing Nov 2017 to Nov 2019

(c) For waste activities, the proposed hours of waste acceptance. NA

(d) Any other relevant hours of operation expected (e.g., waste handling, etc.). NA

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9.5. Review of a Licence Where the Office of Environmental Enforcement (OEE) has agreed any variations or adjustments to the conditions or schedules of the

existing licence, the licensee must provide details of these agreed variations and adjustments to the existing licence conditions in the table

that follows.

An updated, scaled drawing of the site layout (no larger than A3) providing visual information on such adjustments or variations where

appropriate should be uploaded in the site tab – ‘site plan(s)’ upload.

In the case of once-off assessments/reports required under conditions/schedules of the existing licence the licensee must provide details of

those assessments/reports that have been completed and agreed with the OEE or as otherwise agreed, in the table below.

Condition/ Schedule

No. Existing Condition

OEE Agreement

Reference Description

Schedule C.2.3 (Stormwater monitoring

point SEMP2)

As per Schedule C.2.3 of IE Licence P0778-01 – Monitoring requirements for SEMP2

LR002117 (May,2013)

1. Removal of the requirement to monitor for pH, TOC, Temperature, COD, total ammonia, total nitrogen and conductivity at SEMP2. 2. Decommissioning of the continuous monitors at the SEMP2 monitoring location. 3. A visual inspection shall continue to be monitored and recorded weekly. No change to the requirements for SEMP3.

Condition 6.19 and Schedule B.2 of Technical

Amendment B:

Condition 6.19 and Schedule B.2 of Technical Amendment B of IE Licence P0778-01 – Monitoring Requirements for SEMP4

LR024239 (Sep, 2016)

Change to monitoring requirements on SEMP4: going forward TOC, pH, Conductivity, visual inspection, and odour assessment are to be monitored on a weekly basis. There is no requirement to conduct continuous monitoring on SEMP4.

Schedule C.6 Ambient Groundwater Monitoring Schedule

LR028572 (Apr, 2017)

In accordance with Condition 1.4 in April 2017, Janssen requested to relocate and decommission AGW01 due to the requirement to conduct civil works in the vicinity and replace the existing well with a new Groundwater Monitoring Point (AGW05) located as close as possible to the current position of AGW 01. EPA approval was granted via LR028572.

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Once-off

assessments/reports

Condition 6.8

“The licensee shall prepare a programme, to the satisfaction of the Agency, for the identification and reduction of fugitive emissions. This programme shall be included in the Environmental Management Programme.“

NA

Janssen commissioned a ‘Fugitive Emissions and Solvent Management Plan’ in 2009. The 2009 report concluded: “Due to the current level of engineering controls and handling practices, and to the nature of the raw materials used, fugitive emissions are not deemed to be of a significant environmental impact. However, in order to continuously improve the sites environmental performance programs have been proposed for the reduction in fugitive emissions. These relate specifically to the usage and emission of IPA utilised for disinfection on site and the reduction in waste from containers, in particular relating to residual material in IBCs.”

Condition 6.12 as Amended by Technical

Amendment A

“Warning and action levels for stormwater at SEMP2 and SEMP3 shall be submitted to the Agency as part of the AER.”


Note as per LR002117 (May,2013) above, continuous monitoring is no longer required at SEMP2. Warning and Action levels are required to be set for SEMP3 in accordance with Condition 6.12

Condition 6.18

“The licensee shall within six months of the commencement of the activity prepare an odour audit of the installation to include: the Waste Water Treatment Plant; the autoclaves; and vents from the thermal inactivation process area. The report of the audit shall contain proposals for any additional measures required to comply with Condition 5.2. “

NA

Janssen commissioned an “Odour Impact Assessment” in 2009.

The 2009 report concluded that “no odour emissions from activities carried out at the site shall result in an impairment of, or an inference with amenities or the environment beyond the facility boundary or any other legitimate use of the environment beyond the installation boundary” and subsequently thus inferring compliance with Condition 5.2.


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EPA Application FormPollution prevention measures may, inter alia, include the following...

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