Guidance on. Significant Modifications. Under the. COMAH Regulations

Transcription

1 Guidance on Significant Modifications Under the COMAH Regulations 1 P age

2 Table of Contents Glossary of terms... 3 The COMAH Regulations... 4 Purpose of this Guidance... 4 Acknowledgements... 4 What is a Significant Modification?... 5 Deciding if a modification is significant... 5 Preliminary Analysis... 6 Detailed Analysis... 6 The CCA s Assessment Process... 8 Examples Example 1: Changed contents of a storage tank containing toxic liquid Example 2: Introduction a new process in the Pharmachem sector Example 3: Warehouse change in inventory Example 4: Inventory increase at a fuel terminal Appendix 1 COMAH Regulations 12 and Appendix 2 - Significant Modification Assessment Procedure Annex 1 Minimum Risk in the LUP Referral Context Appendix 3 Log for a modification requiring preliminary analysis only Appendix 4 Communicating risk analysis to CCA Appendix 5 Flow Chart description of process P age

3 Glossary of terms ALARP API ATM BAT BATC BREF CBA CCA CDOIF COMAH CPM EV HSA IPL JRC LOC LOPA LUP MAPP MATTE PA PLL SIL SRI TWG VCE As Low As Reasonably Practicable Active Pharmaceutical Ingredient Additional Technical Measure Best Available Techniques Best Available Techniques (BAT) Conclusions Best Available Techniques (BAT) Reference Documents Cost Benefit Analysis Central Competent Authority Chemical and Downstream Oil Industry Forum Control of Major Accident Hazards Chance Per Million Expectation Value Health and Safety Authority Independent Protection Layer Joint Research Centre Loss of Containment Layer of Protection Analysis Land Use Planning Major Accident Prevention Policy Major Accident to the Environment Planning Authority Potential Loss of Life Safety Integrity Level Societal Risk Index Technical Working Group Vapour Cloud Explosion 3 P age

4 The COMAH Regulations The Chemicals Act (Control of Major Accident Hazards Involving Dangerous Substances) Regulations 2015, S.I. 209 of 2015 (the COMAH Regulations ), implement the Seveso III Directive (2012/18/EU). The COMAH Regulations lay down rules for the prevention of major accidents involving dangerous substances, so as to limit, as far as possible, the consequences of such accidents for human health and the environment: the overall objective is to provide a high level of protection to human health and the environment in a consistent and effective manner. This is achieved through tiered controls on the operators of those establishments subject to the COMAH Regulations (the larger the quantities of dangerous substances present at an establishment, the more onerous the duties on the operator) and controls on developments at establishments and in their vicinity. The COMAH Regulations apply to any establishment with a presence of dangerous substances in quantities that exceed the thresholds specified in the Regulations. The list of dangerous substances and their threshold quantities are specified in Schedule 1 to the COMAH Regulations. The Health and Safety Authority is the Central Competent Authority ( CCA ) for the purpose of the COMAH Regulations. Detailed Guidance on the COMAH Regulations is available on our website. That Guidance should be consulted for a more detailed exposition of the Regulations. Purpose of this Guidance This guidance has been designed to assist the operators of COMAH establishments who are contemplating making changes and are striving to determine whether such changes could be considered as significant modifications under the COMAH Regulations. It will help them to determine if contemplated changes fall into this category and if so, the information that should be prepared and sent to the CCA well in advance of the modification schedule. This Guidance also sets out how the CCA will assess such significant modifications and illustrates this with a number of worked examples. Acknowledgements The Guidance has been prepared with the assistance of the COMAH Significant Modifications Technical Working Group (TWG) set up under the COMAH Cost Review Group. The HSA wish to thank the following for their participation and input to the Working Group: Aisling O Connor (Pfizer Ireland Ltd.) Andrew O Callaghan (Goulding Chemicals Ltd.) Bob Loade (BOC Gases) Damien Roche (Roche Freight) Fergal Leonard (Flogas and LPG Industry Representative) Finbar Constant (Irish Oxygen Company Ltd.) 4 P age

5 Gervase McAleavy (Pernod Ricard) Iggy Marum (Merck Millipore) John Craig (Atlantic Fuel Supply Company and Irish Petroleum Industry Association) Michael Buckley (Novartis Ringaskiddy Ltd.) Niamh Donohoe (Intel Ireland) Paschal Byrne (BOC Gases) Rita O Sullivan (Eli Lilly Kinsale Ltd.) Ruth Donohoe (TOP and Irish Petroleum Industry Association) The TWG set up an expert group to provide assistance on addressing the relevant technical issues. The HSA wish to thank the following for their participation and input to the Expert Working Group: Adrian Watson (Managing Director, Project Design Engineers) Brenda Madden (Senior Process Safety Engineer, PM Group) Denis Curtin (Consulting Process Safety Engineer, Denis Curtin Ltd) Maeve McKenna (Principal Risk Consultant, AWN Consulting) Roger Casey (Senior Consultant, Cantwell, Keogh & Associates) Sinead Keohane (Lead Process Safety Consultant, PM Group) Tom Leonard (Partner, Byrne O Cleirigh) Tracey Kelly (Professional Process Safety Engineer) What is a Significant Modification? Article 11 of the Seveso III Directive states: In the event of the modification of an installation, establishment, storage facility, or process or of the nature or physical form or quantity of dangerous substances which could have significant consequences for major-accident hazards, or could result in a lower-tier establishment becoming an upper-tier establishment or vice versa, Member States shall ensure that the operator reviews, and where necessary updates the notification, the MAPP, the safety management system and the safety report and informs the competent authority of the details of those updates in advance of that modification. This has been implemented in the COMAH Regulations under Regulations 12 and 24 (the full text of which are in Appendix 1 to this document). The term significant modification is not used in either the Directive or the COMAH Regulations but is commonly used (and is used here) to describe the modifications encompassed by Regulation 12. The COMAH Regulations are not entirely explicit on the modifications to be controlled or on how the Central Competent Authority (CCA) will assess the significance of a modification, so this guidance document has been produced to provide greater clarity in this area and to make clear when the CCA will refer a modification to the Planning Authority (PA), in accordance with Regulation 24(5). Deciding if a modification is significant Appendix 2 sets out the complete approach an operator should take when analysing a significant modification and describes in detail how the CCA will go about making the assessment. The remainder of this Guidance gives an overview of that system and work through a number of examples to illustrate its operation. 5 P age

6 It is essential that operators assess anticipated significant modifications at an early stage, because the COMAH Regulations require plans to be submitted in advance: an early consideration of the modification allows a greater range of options to come under consideration by the operator. Preliminary Analysis The process begins with the operator performing a preliminary analysis (Appendix 2 sets out the complete process). Figure 1: the preliminary analysis If and only if, the preliminary analysis indicates the change is potentially significant will a detailed analysis be required. Otherwise, the operator maintains a simple log of the modification (such as shown in Appendix 3). The results of the preliminary analysis should be retained for examination during future CCA inspections, for a period of 3 years. Detailed Analysis Where indicated by the preliminary analysis, the operator must then carry out a detailed analysis (Appendix 2 sets out the complete process). Figure 2, below, gives an overview of the approach: 6 P age

7 Figure 2: Detailed analysis by operator In this stage of the analysis, the operator characterises the consequences and risks subsequent to the proposed modification, to the level of detail necessary to enable the determination of its significance. The number of people (or environmental receptors) affected, the extent of that effect and the frequency of occurrence (using figures from the Policy and Approach of the HSA to COMAH Risk Based Land Use Planning) are all subjected to analysis, using the methodology set out in Appendix 2. 7 P age

8 If the risk following the modification is estimated to be broadly acceptable (fatality risk < 1 x 10-6 per annum or the equivalent environmental criterion) without the need to implement further technical measures ( additional technical measures ATMs), then the operator should update the relevant documents 1 and send them in advance to the CCA. The communication form in Appendix 4 (with Section 1 completed) should accompany the documentation (preferably send to COMAH@hsa.ie). If the risks are not broadly acceptable then the operator should look to apply ATMs that will bring the fatality risk to a tolerable level (in the range 1 x 10-4 to 1 x 10-6 for people onsite and less than 1 x 10-6 at offsite locations). The operator is expected to bring the risk following the modification to a level that is as low as reasonably practicable. Therefore, reasonable ATMs should be implemented and a cost benefit analysis will be required, to show that it was not reasonable to implement further additional technical measures. When the risk has been demonstrated to be as low as reasonably practicable (ALARP), the operator should update the relevant documents and send them in advance to the CCA. The communication form in Appendix 4 (with Section 2 completed) should accompany the documentation (preferably send to COMAH@hsa.ie). If the risks are not as low as reasonably practicable then the operator must look at ATMs that will bring the risk within the ALARP range. If the onsite risks cannot be brought within the ALARP range the modification will not be permitted by the CCA. The operator should update the relevant documents and send them in advance to the CCA. The communication form in Appendix 4 (with Section 3 completed) should accompany the documentation (preferably send to COMAH@hsa.ie). Where the offsite risk criterion is exceeded the modification will be referred to the planning authority, under Regulation 24(5), with appropriate technical advice. The operator should update the relevant documents and send them in advance to the CCA. The communication form in Appendix 4 (with Section 4 completed) should accompany the documentation (preferably send to COMAH@hsa.ie). The CCA s Assessment Process The CCA reviews the documentation submitted by an operator in support of a modification in two distinct stages. In the first stage the on-site risk is evaluated while in the second stage it is the off-site risk. On-site Risk evaluation Figure 3 (below) shows the flow of the assessment. 1 The relevant documents are: the notification under Regulation 8, the MAPP and safety management system under Regulation 10, the safety report under Regulation 11 and any relevant risk assessment 8 P age

9 The first decision point for the CCA is whether the on-site human health and environment risk following the modification will be acceptable, that is, will the risk of fatality to people be below 1 x 10-6 per year? If it is (and the societal risk is tolerable) then the CCA will permit the modification. If the risk is greater than this value, the CCA will look for data from the operator on whether additional technical measures would bring the risk within the tolerable range (1 x 10-4 to 1 x 10-6 per year risk of fatality). If no ATMs are possible (or implementable) then the CCA will reject the modification. 9 P age

10 Figure 3: CCA assessment of on-site risk Where ATMs are possible, the CCA assesses whether the risk can be brought within the tolerable range through the use of those additional technical measures and whether all the reasonably practicable technical measures have been applied to bring the risk to as low a level as possible. If the CCA is satisfied on this point (and the societal risk increase is tolerable) then the CCA will permit the modification, subject to the implementation of the ATMs. If the CCA is not satisfied, the modification will be rejected unless the operator can identify additional technical measures to bring the risk to the ALARP level. The CCA will advise the operator within 4 weeks of receiving the appropriate documentation. Assessment of modifications is a chargeable activity under the COMAH Regulations (Significant change under Regulation 12. The minimum charge of 1,800 covers the first 3 days of assessment time; the maximum charge is 6,000). Off-site Risk evaluation The first decision point for the CCA is whether the off-site location risk, following the modification, will be acceptable: that is, will the risk be below 1 x 10-6 per year 2 fatality level? A separate environmental risk evaluation determines if it will be broadly acceptable according to the CDOIF 3 methodology. If it is (and societal risk increase is tolerable) then the CCA will permit the modification without referral to the planning body. If the risk is greater than this value, the CCA will expect the operator to explore whether additional technical measures, which would bring the risk below this level, are possible. If the operator can robustly demonstrate that none are justifiable, then the CCA will refer to the planning authority, with technical advice, in accordance with the Policy and Approach document. If the risk can be brought below the target value through the use of additional technical measures, and these technical measures are within the control of the operator, then the CCA will permit the modification without referral to the planning body. If the risks can only be brought below the target value through the use of additional technical measures, and these technical measures are not within the control of the operator, then the CCA will refer to the planning authority, with technical advice in accordance with the Policy and Approach document. Figure 4 shows the flow of this part of the assessment: 2 This is relaxed to 5 x 10-6 per year if all relevant neighbours are considered to be industrial in nature 3 Chemical and Downstream Oil Industries Forum publication : Guideline on Environmental Tolerability for COMAH Establishments, v P age

11 Figure 4: CCA assessment of the off-site risks Change of tier Tier change is specifically identified in Regulation 12 as a significant modification. Permission Significant modifications must be notified in advance to the CCA and, under Regulation 24(6), the operator may proceed only if the specified ATMs are put in place and if formal permission is given to the operator by the CCA. Where a modification is referred to a planning authority (PA), the modification may not proceed until permission has been received from the planning authority, or, if the referral has been declined by the PA, the CCA. 11 P age

12 Examples All examples are fictitious and while the risk figures used draw on those in the Policy & Approach document they are not to be taken as the figures to be used in a particular situation. Advice should always be sought from a competent person. Example 1: Changed contents of a storage tank containing toxic liquid Modification An establishment storing toxic liquid in bulk intends to change the contents of a storage tank from substance X to substance Y. How significant is this modification? Analysis The relevant major accident scenario is determined to be a loss of containment (LOC) from the tank into the bund. It is assumed all of the tank contents will be held within the bund (dimensions 10m x 5m). Therefore there will be no significant change in the volume of dangerous substance spilled. There are no other risk sources in the immediate area. Three routes to a major loss of inventory to the bund have been identified by the operator: loss of containment through a hole in the tank; a piping failure; a catastrophic failure of the tank. LOC frequencies, given on page 29 of the Policy and Approach document, are used to estimate the risk levels. In this way, the overall annual frequency of this accident is determined by the operator to be 1.1 x Modelling in ALOHA suggests, for the pre-modification scenario, that the concentration of the existing substance (X) at a distance 10 metres from the bund would be ~2,000 ppm which equates to a 3% fatality rate. This puts the existing annual fatality risk (RR aaff ) at the location 10 metres outside the bund as: RR aaaa = = pppppp yyyyyyyy 12 P age

13 Similar modelling for the post-modification scenario suggests a concentration of 1,200 ppm of the new substance(y), leading to an estimate of 8.5% fatality (using a relevant Probit equation, such as those listed in appendix 3 of the Policy and Approach document). As there is an increase in the consequences, a detailed assessment is required. The new annual fatality risk at the location 10 metres outside the bund is: RR aaaa = = pppppp yyyyyyyy So, the analysis predicts an increase in the location-based on-site risk and the risk level following the modification would lie towards the middle of the 10-6 to 10-4 range. The operator then analyses whether people would be exposed to this risk. It is found that the maximum time a person could be present was 25% of the time. Therefore the annual on-site individual fatality risk was calculated to be: RR aaaa = = pppppp yyyyyyyy While the on-site fatality risk is lower than originally calculated, it still falls within the ALARP range and the operator must consider the identification and application of additional technical measures and, if it is not intended to apply them, the operator must provide a solid justification for this in the appendix 4 communications to the CCA. There are no sensitive environmental receptors offsite and no pathway for a spillage to go offsite, so no further environmental assessment is required. Alternative Scenario All the conditions in the example above apply, but, in addition, because one end of the bund is adjacent to the site external boundary, there are off-site risks to be considered. So, as well as completing the on-site analysis described above, the operator must also carry out an off-site risk analysis. As shown above, the new annual off-site risk figure is 9.35 x As the off-site criterion is locationbased and does not depend on the presence of people, the acceptable individual risk criterion will be exceeded. The operator now has to consider additional technical measures and, if not intending to apply them, provide a strong justification in the appendix 4 communication to the CCA. 13 P age

14 In this situation the operator should also consider societal risk. If it is assumed that 10 people are present within the risk contour, the Expectation Value (EV A ) would be: EEEE AA = RR cccccc NN = = 93.5 (Increased frequency of accident in chances per million x number of fatalities) As this is below the action level of 450 for a detailed societal risk assessment, no further societal risk evaluation is required. In these circumstances, the CCA would refer to the planning authority, with appropriate technical advice, in accordance with the Policy and Approach document. 14 P age

15 Example 2: Introduction a new process in the Pharmachem sector Modification An operator intends to introduce a new process to the establishment and must decide if it s a significant modification and what information should be supplied to the CCA. Analysis The establishment has a number of process buildings on a large rural site. In the relevant process building there could be up to a maximum of 4 different processes in progress at any one time. Up to this time, the operator has not performed a formal quantified risk assessment on the risk to the operatives present in the building. The operator carries out a preliminary assessment and this indicates that the consequences from the worst case accident for the new process are somewhat worse than for any of the existing 4 processes. As there is an increase in the consequences, a detailed assessment will be required. In establishing the necessary major accident preventative control measures, the operator already uses the LOPA 4 (Layers of Protection Analysis) technique. The target value set by the operator is a risk of operative fatality less than 1 x 10-5 per year (once per hundred thousand years). To achieve this, the operator applies good practice to the design of the process and the equipment used, which will comply with relevant standards and guidelines and generally with good practice. In addition, an IPL (Independent Protection Layer) consisting of a hardwired interlock etc. and with a SIL 2 rating will be installed. As a result, the LOPA technique indicates the target risk value will of 1 x 10-5 per year be met. The same approach had been previously taken with the four existing processes and similar levels of protection were achieved. The process building operates continuously for 50 weeks per year, staffed by a maximum of eight operatives at any one time. In the new situation, with a maximum 5 processes running simultaneously in the process building, an individual operative s fatality risk is: (to account for the 5 processes) RR aaff = = pppppp yyyyyyyy RR aaaa = = pppppp yyyyyyyy (to account for the maximum time a particular operator is present) Therefore the overall individual risk level in the new situation puts it in the middle of the ALARP zone. 4 Layer of Protection Analysis: Simplified Process Risk Assessment (Centre for Chemical Process Safety, 2001) 15 P age

16 Societal risk There are a maximum of 8 operatives present at any one time in the hazard areas of the process building. The initial societal risk calculation looks only at the increased level of risk. The increased risk of fatality is taken as: RR aaaa = pppppp yyyyyyyy = 10cccccc The fatality proportion in an explosion in this situation is assumed as 0.75 (using the Probit equation from page 9 of the Policy & Approach document and a modelled overpressure of 179 kpa), which means for 8 operators, N= 6. The Expectation Value is therefore: EEEE AA = RR cccccc NN = 10 6 = 60 This is below the threshold value of 450 and so there is no requirement for a full societal risk assessment. Conclusion The risk is in the ALARP zone. The operator complies with all relevant good practice and exceeds it in using additional technical measures where required by LOPA. The operator forwards a case to the CCA that the risk is tolerable and that no further measures are necessary, with an updated notification and safety report and awaits a decision. Given the human risk level and that environmental risks are not relevant, the absence of possible further technical measures and the quality of the case presented, the CCA would most likely consider the risk to be ALARP and allow the modification. 16 P age

17 Example 3: Warehouse change in inventory Modification The operator of a lower-tier establishment has bid for a contract to store material for an API manufacturer and is considering whether to notify the HSA of a significant modification. Analysis The operator follows good practice in the warehousing of dangerous substances and ensures incompatible substances are always segregated. The warehouse is appropriately zoned under the Hazard Area Classification standard. The worst case major accident has been identified as a warehouse fire. The new contract will involve storage of up to 10 tonnes of a dangerous substance with the hazard category H 203 (risk of explosion by shock, friction, fire or other sources of ignition), Seveso category P1a. The substance is a solid. None of the existing dangerous substances in the warehouse have this hazard classification. The material will be in 50 kg drums, stored four per pallet. Storage of the substance will not bring the operator into the upper-tier classification. As a new type of hazard is being introduced, a detailed analysis will be required. The detailed assessment identifies that generally an explosion can be ruled out, except in the situation of a fire in the warehouse. The warehouse does not have sprinkler system and will, essentially, rely on a response from the local fire service to extinguish a fire. The fire brigade response time is confirmed by the emergency responders to be 15 minutes. The frequency of a major fire in the warehouse is estimated at 1 x 10-4 per year and a minor fire at 1 x 10-3 per year (page 28 of Policy & Approach document). A minor fire in the vicinity is postulated to have a low probability of leading to an explosive event, while for a major fire the likelihood of a fire engulfing this material and causing an explosion is higher. It is assumed that 10% of minor fires and 50% of major fires could result in an explosion. This puts the explosion frequency at: RR aaaa = ( ) + ( ) = pppppp yyyyyyyy Fatal overpressures from such an explosion would be experienced within a 50 m radius. Emergency responders as well as site personnel would be at risk. 17 P age

18 The site operates 60 hours (five 12 hour days) per week only. Site personnel will therefore be present for a maximum of: 60 (7 24) = 0.36 of the time. The maximum risk to any employee from the explosion is put at: RR aaaa = = pppppp yyyyyyyy The operator presents a case to the CCA that the risks are ALARP. The CCA notes the risk is close to the intolerable line (10-4 ) of the ALARP zone and that only the risk related to the explosion has been presented and not the total major hazard risk to the most exposed employee. It also notes that ATMs have not been identified, even though some obvious measures (installing a sprinkler system, putting the material in a separate building) are worthy of consideration. Further assessment of the risk and the application of additional technical measures to reduce that risk will be required. The documentation presented to the CCA does not address the societal risk level. In the event of fire, the fire brigade personnel would almost certainly be present and fighting the fire at the time an explosion could occur. The explosion frequency is: (see above) RR aaaa = pppppp yyyyyyyy If 6 fire personnel were present along with 2 site operatives, the number of fatalities, given a fatal fraction of 0.83 (using the Probit equation from page 9 of the Policy & Approach document and a modelled overpressure of 193 kpa) would be expected to be 5. Since the Expectation Value (EV) - there are also societal risk concerns. EEEE AA = RR cccccc NN = = 750 Therefore the operator will be required by the CCA to have a competent person carry out a cost benefit analysis to establish if additional technical measures are reasonably practicable and a more detailed societal risk assessment to produce an FN curve. Environmental Risk The CCA would also be concerned that the site lacks the retention capability for contaminated firewater runoff. The frequency of a major fire event is estimated at 1 x 10-4 per year and a substantial quantity of contaminated firewater would be generated. Therefore a MATTE source exists. A stream runs near the plant and sensitive receptors are considered likely to be present. It is 18 P age

19 considered likely that in a fire event, a significant amount of firewater would reach the important receptors. Based on CDOIF methodology, this would be considered to be a MATTE of consequence type C. According to the table (Box 7 in appendix 2 of this document), the frequency (per receptor per year) of this event is deemed intolerable if it exceeds 1 x10-4 per year, which is uncomfortably close to the major fire risk for this site. The CCA therefore would also require the operator to provide a fuller environmental risk assessment and consideration of additional technical measures. The risk levels do not extend offsite in this case, but if they did a referral to the planning authority under Regulation 24(5) would also be necessary. 19 P age

20 Example 4: Inventory increase at a fuel terminal Modification A fuel storage terminal stores 12,000 m 3 Class I Petroleum, 13,000 m 3 Class III and 56,000 m 3 Class II petroleum. It intends to double Class I storage. This will result in double the daily throughput of road tankers, from 100 to 200. Analysis The operator had previously notified the CCA of the storage 12,000 m 3 Class I Petroleum in a tank of nominal capacity 24,000 m 3. Filling above the 12,000m 3 level was reliably prevented through the implementation of a safety instrumented function complying with IEC The operator carried out a preliminary analysis and decided the change wasn t significant. During a subsequent routine COMAH inspection, the inspector queried the change log (appendix 3) that recorded the change as not significant. As the relevant loss of containment frequencies in the Policy and Approach document (Page 20) are per tank, and there has been no increase in the number of tanks, the risk of a loss of containment from a tank has not increased. However, in the event of a catastrophic loss of containment, a much greater quantity of Class I Petroleum would now overtop the bund. Therefore the operator should have carried out a detailed assessment. The operator was advised by the advising technical consultant that the risk of a VCE related the storage tank remained unchanged. However the risk in the tanker loading bay had doubled because the number of Class I truck movements had doubled. Also a much larger pool fire outside the bund would now be possible. The fatal consequence zone would increase. Therefore a detailed analysis should have been undertaken and the risk to onsite personnel calculated. There would be also a possibility of a significant proportion of the overtopping fraction leaving the establishment and affecting the sensitive estuarine environment - this should have been considered. The inspector prohibits the storage above the original notified quantity and requires the operator to notify a significant modification and supply the necessary documents for consideration. 20 P age

21 Appendix 1 COMAH Regulations 12 and 24 Regulation 12 Modification of an installation, establishment or storage facility 12. (1) An operator shall review and where necessary update (a) the notification under Regulation 8; (b) the MAPP and safety management system under Regulation 10; and (c) the safety report under Regulation 11; prior to the modification of an installation, establishment, storage facility, or process or of the nature or physical form or quantity of dangerous substances which could have significant consequences for major accident hazards, or could result in a lower-tier establishment becoming an upper-tier establishment or vice versa. (2) Whenever an operator carries out a review referred to in paragraph (1), the operator shall inform the Central Competent Authority of the details of any update arising thereunder in advance of any such modification and in sufficient time to allow the Central Competent Authority to carry out its functions under Regulation 24. Regulation 24 Technical advice on land-use planning 24. (1) The Central Competent Authority shall, on receiving a notification under Regulation 8, advise a planning authority of a consultation distance for that establishment, if it is within the planning authority s functional area or could affect its functional area, and the Central Competent Authority shall periodically review this advice and update it as necessary. (2) The Central Competent Authority shall provide technical advice in response to a notice sent by a planning authority under Part 11 of the Planning and Development Regulations 2001 (S.I. No. 600 of 2001), requesting technical advice on the effects of a proposed development on the risk or consequences of a major accident in relation to the following types of developments within the consultation distance notified in paragraph (1) (a) the siting and development of new establishments; (b) modifications to establishments of the type described in Regulation 12(1); (c) new developments including transport routes, locations of public use and residential areas in the vicinity of establishments, where the siting, modifications or developments may be the source of, or increase the risk or consequences of, a major accident. (3) The technical advice provided by the Central Competent Authority to a planning authority pursuant to paragraph (2) may be generic or case specific in nature and shall be so formulated that it will assist the planning authority to take into account the need, in the long term (a) to maintain appropriate safety distances between establishments covered by these Regulations and residential areas, buildings and areas of public use, recreational areas, and, as far as possible, major transport routes; (b) to protect areas of particular natural sensitivity or interest in the vicinity of establishments, where appropriate through appropriate safety distances or other relevant measures; and 21 P age

22 (c) for the operator to take additional technical measures, in the case of existing establishments, in accordance with Regulation 7, so as not to increase the risks to human health and the environment. (4) In the case of existing establishments, the Central Competent Authority shall review proposed modifications of the type described in Regulation 12(1), which do not constitute development as defined in section 3 of the Planning and Development Act, to determine whether additional technical measures consistent with the operator s duties under Regulation 7 should be taken, so that such modifications will not increase the risks to human health and the environment. (5) If, in the opinion of the Central Competent Authority, a proposed modification reviewed under paragraph (4) is considered to be a significant change it shall be referred by the Central Competent Authority, with relevant technical advice, to the relevant planning authority under section 5(1) or section 5(4) of the Planning and Development Act, for a declaration as to whether the proposed modification is or is not development or is or is not exempted development within the meaning of that Act. (6) Where the Central Competent Authority informs the operator pursuant to paragraph (4) that the proposed modification shall not proceed until the specified additional technical measures are taken by the operator, the operator shall not carry out the modification unless the said specified measures are put in place. (7) Where the Central Competent Authority informs the operator pursuant to paragraph (5) that the proposed modification shall be referred to the relevant planning authority, the operator shall not carry out the modification unless either a declaration is obtained that the proposed modification is not development, or is exempted development in which case paragraph (8) applies, or planning permission is obtained in respect of the proposed modification. (8) Where the planning authority issues a declaration under section 5 of the Planning and Development Act that a proposed modification referred to it under paragraph (5) is not development, or is exempted development, then it shall be dealt with by the Central Competent Authority under paragraph (4). (9) The Central Competent Authority shall provide the technical advice referred to in paragraph (2) within four weeks of receiving a request from a planning authority. (10) Without prejudice to paragraph (9), where the Central Competent Authority requires additional information in order to provide the requested technical advice to the planning authority under paragraph (2), the following shall apply (a) the Central Competent Authority shall request the information from the planning authority within two weeks of the receipt of the request for technical advice; (b) the planning authority shall provide the additional information requested by the Central Competent Authority, if necessary after requesting it from the applicant; (c) the Central Competent Authority shall provide technical advice to the planning authority within four weeks of receiving the requested information. (11) Operators of establishments shall provide sufficient information to the Central Competent Authority as part of the notification in Regulation 8 or an update under Regulation 12(2), and at any time at the request of the Central Competent Authority, on the risks arising from an establishment, necessary for the fulfilment of the Authority s functions under this Regulation, and in particular to ensure that technical advice on those risks for land-use planning purposes is available. (12) Where the Central Competent Authority or a planning authority becomes aware, in the exercise of their functions under these Regulations or under the Planning and Development Act and the Planning and 22 P age

23 Development Regulations 2001, of the possibility of a major accident with transboundary effects originating in an upper-tier establishment, it shall provide sufficient information to the competent authorities that have responsibility for the preparation and implementation of external emergency plans in respect of such establishments in the potentially affected other Member State so as to permit the latter to ensure that all relevant provisions contained in Articles 12 and 13 of the Directive can, where applicable, be applied by those authorities. 23 P age

24 Appendix 2 - Significant Modification Assessment Procedure 1. Significant Modification Under the COMAH Regulations 2015, an operator is required to consider, at the conceptual stage, whether a modification, of the type listed below, could have significant consequences for major accident hazards: Box 1: Types of modification to be considered by an operator A modification to: an establishment (the whole area under the control of the operator where dangerous substances are present in one or more installations); an installation (a technical unit within an establishment where dangerous substances are produced, used, handled or stored); a storage facility; a process; the nature or physical form or quantity of dangerous substances. 2. Preliminary Consequence Analysis A robust consequence analysis should be carried out on proposed modifications falling into those categories. This initial assessment is to determine whether the modification will increase the current consequences of the major accident hazards at or outside the establishment. The hazards that should be considered are those arising from: fire, energy release / explosion, toxic release and their consequent effects on human health and the environment. The consequence endpoints to be used for this assessment are: Box 2: Consequence Endpoints Hazard Consequence Endpoint to be used Fire Thermal Radiation To 6.8 KW/m2 Explosion Overpressure To 168 mbar Toxic Release Fatality Threshold of fatality 1%- using a probit from Appendix 3 of the LUP Policy & Approach document. Fire/explosion/toxic release Environmental Damage Increase in number of receptors affected or more severely affected or more likely to be affected. The relevant endpoints in box 2 are taken the HSA s LUP Policy and Approach document 1. 1 Policy & Approach of HSA to COMAH Risk-based LUP, HSA P age

25 The preliminary assessment should examine the major accident potential of the proposed modification, before any additional preventive or protective measures have been considered. The operator may have to update the Hazid/Risk Assessment on foot of this initial assessment. It should also be clear at this point whether at least some of the relevant documents will have to be updated (even if the modification is ultimately deemed not to be significant). Box 3: Relevant documents that may require update prior to a modification the notification under Regulation 8; the MAPP and safety management system under Regulation 10; the safety report under Regulation 11; If the initial assessment suggests that the distance at which consequences (endpoints listed in box 2) could be experienced will increase, then a detailed analysis is expected. If the consequence distance would not increase as a result of the modification, but the consequences are intensified (more receptors affected or affected to a greater extent or are more likely to be affected) then this could also constitute a significant modification and detailed analysis will be expected. 3. Detailed Analysis a. Introduction If it becomes clear from the preliminary analysis that the proposed modification has the potential to be significant, then it must be evaluated in more detail. This is referred to as detailed analysis. At this point the modification is considered to be potentially significant and that Regulation 12 applies to it. Some of the questions to be answered at this stage include: Box 4: Second stage analysis of a modification Are more persons now likely to be affected (how many) or affected for a longer period (how long)? Is more of the environment likely to be affected (how much) or affected for a longer period (how long)? Are more persons or the environment now at increased risk? Broadly, how much more likely is it that the major accident will happen? Broadly, how much greater is the risk to receptors? In planning for a modification, an operator should always apply good practice: application of good practice will be the starting point for deciding whether all the necessary measures for the prevention 25 P age

26 and mitigation of major accidents, required by Regulation 7, are being taken. For environmental hazards, good practice can be obtained from published sources, including relevant guidance or from BAT reference documents (BREFs) and the associated BAT conclusions (BATC) etc. documents. If it is established that there are potentially significant consequences from the proposed modification, then the operator should address additional measures that could be relevant and how they could be implemented so as to prevent and mitigate those consequences and minimise the risk. The general principles of prevention 2 give a good general hierarchical approach to this: Box 5: The General Principles of Prevention 1. The avoidance of risks. 2. The evaluation of unavoidable risks. 3. The combating of risks at source. 4. The adaptation of work to the individual, especially as regards the design of places of work, the choice of work equipment and the choice of systems of work, with a view, in particular, to alleviating monotonous work and work at a predetermined work rate and to reducing the effect of this work on health. 5. The adaptation of the place of work to technical progress. 6. The replacement of dangerous articles, substances or systems of work by safe or less dangerous articles, substances or systems of work. 7. The giving of priority to collective protective measures over individual protective measures. 8. The development of an adequate prevention policy in relation to safety, health and welfare at work, which takes account of technology, organisation of work, working conditions, social factors and the influence of factors related to the working environment. 9. The giving of appropriate training and instructions to employees. If an operator proposes not to implement the best available options, a case should be prepared to justify such an approach. Operators should respect the spirit of their Major Accident Prevention Policy and the requirement to ensure a high level of protection of human health and the environment and their commitment to continuously improve the control of major accident hazards (Regulation 10(3)): the prevention and mitigation measures proposed should reflect those duties. Regulation 24 (3)(c) requires the CCA to review proposed modifications to assess whether additional technical measures consistent with the Regulation 7 obligations should be taken, so that the modifications will not increase the risks to human health and the environment. Additional Technical Measures (ATMs) are not defined in the Regulations. However they are measures additional to current good practice (which include procedural and administrative measures) and are technical in nature. The JRC s land-use planning guidelines 3 (in Part A, Section 6) 2 See Schedule 3 of the Safety Health & Welfare at Work Act Land Use Planning Guidelines in the Context of Directives 96/82/EC and 105/2003/EC, JRC P age

27 provide a definition of additional technical measures in the context of Article 12 (covering the landuse planning aspects of the Directive) as: measures that reduce the likelihood and/or mitigate the consequences of a major accident as effective as the establishing of a distance to the relevant vulnerable recipient; this involves consideration of whether there are measures at or outside the establishment in addition to those already in place. Typically ATMs will involve additional layers of protection or lines of defence, whose reliability can be quantified to a level that allows an informed assessment to be made. Figure 5: Active and passive measures for risk reduction and emergency response 4 The following sections will set out in more detail the way in which on-site and off-site human health and the environmental risks and proposed prevention and mitigation measures should be addressed in the documentation submitted to the CCA and then how the CCA will go about forming its judgement. 4 From Overview of Roadmaps For Land-Use Planning In Selected Member States, JRC 2008, ISSN P age

28 b. On-site Risk Analysis In analysing a change in onsite risk, as part of the detailed analysis, the following questions will provide a useful starting point: Box 6: Significant onsite risk analysis (stage 2) Has the loss of containment (including energy loss) event become more likely as a result of the modification? How many additional people are affected by the increased consequence? To what extent are they affected? How much has the risk (fatality) been increased to those people? Has the environmental risk increased? What additional receptors are potentially affected? To what extent are they affected? Has the extent, severity or duration rating moved up a band (if using the CDOIF 5 methodology)? As it has already been established in the preliminary analysis that there are significant consequences from the proposed modification, some quantification of the additional risk will now be necessary. Major hazard risks to employees are additional to the normal industrial risks and should be kept as low as reasonably practicable. Ideally, any modification should improve the safety of employees and be in accordance with the principles the operator has committed to in the MAPP (to ensure a high level of protection of human health and the environment and to continuously improve the control of major accident hazards). Where there is a potential for a risk increase it should be avoided or, at the very least, kept to a minimum. Where there is a potential for a risk increase, the existing level of risk and the new level of risk are both relevant. The LUP Policy and Approach document provides relevant loss of containment frequencies and appropriate modelling parameters for the analysis. These should be used in establishing the risk level before and after the modification for the onsite risk element, it will be only be necessary to do this in the area of the establishment affected by the increase in risk, where people may be present (so this will exclude bunds, for example). The case presented in the documentation submitted to the CCA in relation to the proposed modification will be assessed by the CCA as follows: If the predicted major accident fatality risk in an affected location is greater than 1 x 10-4 per year after a modification, then the CCA will not permit the modification (although on-site fatality risk of 1 x 10-3 per year is considered just tolerable within the ALARP framework on existing risk, the CCA policy is that, in keeping with the spirit of the MAPP and Article 11 of the Directive and the requirement to continuously improve the control of major accident 5 Chemical and Downstream Oil Industries Forum publication : Guideline on Environmental Tolerability for COMAH Establishments, v P age

29 hazards, significant modifications leading to overall increased on-site risk above the 10-4 level will not be permitted). If, following the modification, the fatality risk to employees in an affected location is greater than 1 x 10-6 per year and less than 1 x 10-4 per year (including where the existing risk falls within this range), then the operator will be required to carry out and document a cost benefit analysis in relation to the provision of additional technical measures, for consideration and approval by the CCA. Potential ATMs should be identified. A cost benefit analysis (CBA) 6 should be undertaken where it is not intended to implement any identified ATMs and a robust case should be presented to the CCA where it is proposed not to implement any ATMs. Where a significant number of people are subject to this level of risk some societal risk evaluation will be necessary. If the on-site fatality risk following the modification is less than 1 x 10-6 per year then no action is necessary and the CCA will allow the modification to proceed without any further requirements. Independent of the above criteria, the following also applies: If the risk of a MATTE on-site exceeds an intolerable level 7 (this is thought to be very unlikely based on current range of establishments) in the table below (taken from the CDOIF) then it will not be permitted, whereas if it is in the tolerable region it will be permitted. Where it is between these values (tolerable if ALARP) a CBA will be required. Box 7: Environmental Criteria (Frequency per receptor per establishment per year) MATTE Type Intolerable: Risk > Broadly Acceptable. Risk < A 1 x x 10-4 B 1 x x 10-5 C 1 x x 10-6 D 1 x x 10-7 For the cost benefit analysis (CBA) the second-stage risk figures should be used. The cost of the ATM should be set out and the benefits of implementing the measure (fewer fatalities, less damage to environment 8 ) should be set against the cost. If the costs of the ATM are not grossly disproportionate then the measure should be implemented. An example of a CBA can be found here: The CCA will assess correctly submitted documentation and respond within 4 weeks. 6 Example of CBA : 7 The environmental risk framework described here is assessed independently of the overall risk to people criteria and zonal advice system that is set out in the Policy & Approach document (that document is expected to be updated in 2018). 8 See Guidance on assessing and costing environmental liabilities, EPA P age