Site Visit Report The site visit process is a sample on a particular day of an installation's compliance with some of its licence conditions. Where non-compliance against a particular condition has not been reported, this should not be construed to mean that there is full compliance with that condition of the licence. Instructions and actions arising from the visit shall be addressed, or where applicable noted, by the licensee in order to ensure compliance, to improve the environmental performance of the installation and to provide clarification on certain issues. The licensee shall take the actions specified to close out the non-compliances and observations raised in this Site Visit Report. Licensee Name of Installation Licensee Takeda Ireland Limited Takeda Ireland Limited Licence Register No. P0693-01 CRO 233508 Site Address Site Visit Reference No. Grange Castle Business Park, Nangor Road, Dublin 22, Dublin SV12567 Report Detail Issue Date 10/10/2017 Prepared By Caroline Kelly Site Visit Detail Date Of Inspection 14/09/2017 Announced No Time In 10:00 Time Out 16:10 Agency Personnel On Site Licensee Personnel and Role Caroline Kelly Victor Olmos Donal Brady, Engineering Director Aileen Stack, Environmental Health and Safety Engineer Katherine Doyle, Environmental Health and Safety Engineer David McCarthy, Distribution Control System Automation Manager Colm Doyle, Maintenance Supervisor Photo Taken No Samples Taken No Video Taken No Odour Assessment No Site Visit Report - SV12567 - Takeda Ireland Limited Page 1 of 6
Scope This site visit was carried out to investigate the breaches of emission limit values (ELVs) at air emission point reference no. EP-P1-03 and to assess the performance and operation of the Volatile Organic Compound (VOC) scrubber at air emission point reference no. EP-P1-02. Media The following medium was inspected during the site visit: Air. Site Areas Inspected The following areas were inspected during the site visit: Hydrogenation scrubber unit in production building (PS1) Air emission point reference no. EP-P1-03 VOC recovery unit at air emission point reference no. EP-P1-02 Flame Ionisation detector (FID) unit at emission point reference no. EP-P1-02. Documents Inspected The following documents were inspected during the site visit: 4.2 - Air emission impact assessment submitted as part of licensee return reference no. LR025785 regarding emission limit value (ELV) breach of TA Luft Class II on 18/03/2016 s 5.1 and 11.1 - Air monitoring report reference no. 8100/M73, Q4 2017 5.1 - Production schedule detailing proposed dates of product batches to be abated through VOC recovery unit to emission point reference no. EP-P1-02 or hydrogenation scrubber to emission point reference no. EP-P1-03 5.1 - Schematic of hydrogenation scrubber (Drawing no. PJB0475) to emission point reference no. EP-P1-03 5.1 - Schematic of VOC recovery unit 'VOC Recovery System Overview' from document reference SOP-ENG-UTIL-35. Site Visit Report - SV12567 - Takeda Ireland Limited Page 2 of 6
1. Site Specific Issues 1.1 Breaches of ELVs at EP-P1-03 Checked 5.1 Yes The Agency and the licensee discussed breaches of ELVs as at emission point reference no. EP-P1-03, in particular: TA Luft Class II on 11/05/2017 of >310.78 & <312.09mg/m3 versus an ELV of 100mg/m3 (see incident reference no. INCI012001) TA Luft Class III on 16/08/2017 of 228mg/m3 versus an ELV of 150mg/m3 (see incident reference no. INCI012840) The licensee stated that it was investigating the breaches. The TA Luft Class II breach of 11/05/2017 occurred during a step 4 hydrogenation phase of a product called 'PSPA'. The TA Luft class III breach of 16/08/2017 occurred during the production of a product called 'TAK-438'. The licensee stated that this was the last batch of 'TAK-438' planned and that it was unlikely that it would be produced again. Further production of 'PSPA' has been scheduled for April 2018. The licensee stated it was currently investigating the cause of the TA Luft Class II breach during the PSPA process and establishing proposed corrective actions. These have yet to be finalised. The Agency requested an update on the progress of an impact assessment into the TA Luft Class II breach on 11/05/2017, which was required to be submitted by 14/08/2017 in accordance with the Agency's instruction issued under incident reference no. INCI012001. The licensee stated that its consultants were in the process of finalising the assessment report and it would be submitted to the Agency. The Agency opened a compliance investigation (CI) reference no. CI001533 related to breaches of ELVs at EP-P1-03. Corrective actions required: The licensee shall: Submit an impact assessment in relation to the TA Luft Class III ELV breach of 16/08/2017 as required under CI Action and Instruction reference no.'s A017902 and A017932. This assessment report was subsequently submitted to the Agency on 02/10/2017 and is currently being assessed by the Agency. Submit an impact assessment report as required under INCI012001 in relation to the TA Luft Class II ELV breach of 11/05/2017. This assessment report was subsequently submitted to the Agency on 29/09/2017 and is currently being assessed by the Agency. Submit a final investigation report into the TA Luft Class II ELV breach on 11/05/2017 as required under CI Action reference no. A018064 by 27/10/2017. 1.2 VOC recovery unit bypasses at EP-P1-02 Checked 5.1 Site Visit Report - SV12567 - Takeda Ireland Limited Page 3 of 6
The Agency reviewed six bypass events at the VOC recovery unit at emission point reference no. EP-P1-03, which occurred during the period 30/01/2015 and 11/03/2016. The Agency requested an update on the progress of corrective actions required under Section 7.2 of site visit reference no. SV08358 which required the licensee to address bypasses of the VOC Recovery unit. There have been no recorded bypasses since 11/03/2016, as recorded under incident reference no. INCI009818. The license stated that the carbon bed was taken apart and underwent a full inspection and maintenance during the last plant shutdown in July 2017. The activated carbon absorption media has been replaced. The licensee has established a preventative maintenance programme in order to eliminate bypass events. This involves a trend analysis of measured TOC levels with action limits to ensure preventative maintenance is carried out before a bypass occurs. Daily checks on the VOC unit are also carried out. There is an interlock in place whereby production shutdown occurs where a reading of 50ppm or higher TOC is recorded. 1.3 Flame Ionisation Detector (FID) at EP-P1-02 Checked 5.4, 11.5, 11.7 Yes The FID hut was visited during the site visit. The licensee explained the arrangements of the two FIDs on site. Only one unit is operative and carries out measurements at a time, the second unit is kept warm to make it operative when needed. The following issues were observed on site: 1. The sample gas was not presented at 180 CDeg to the analyser. The current heated line is only installed up to the CEMS hut, once there flexible unheated tubing is used to bring the sample gas to the analysers. This is not in compiance with section 5.1 of EN 12619:2013 Stationary source emissions Determination of the mass concentration of total gaseous organic carbon Continuous flame ionisation detector method Standard. 2. It was confirmed on site that methane was used as the span gas for the calibration of the FIDs. This was not in compliance with section 4.1 and 5.2.4 of EN 12619:2013 standard. 3. When commisioning the standby FID unit, a single span check using methane is carried out. No checks at zero are performed. Section 5.2.3 of EN 12619 Standard requires the use of a zero gas with a TVOC concentration lower than 0.2 mg/m3 of carbon or purity 99.998%. 4. The measurement ranges of the FIDs are limited to 100ppm. Any reading above this limit is recorded as 100ppm. This would not allow the correct assessment of the potential impact of emissions during bypass events if elevated concentrations of solvents are released. Corrective actions required: The licensee shall: Comply with the requirements of EN 12619 standard. Special attention shall be taken on the mandatory sampling train requirements and calibration procedure. Ensure that the FID measurement range is adjusted at all times according to the concentration of emissions being released at any given time. 1.4 Impact assessment report re: INCI0110045 Checked 4.2 No Yes Site Visit Report - SV12567 - Takeda Ireland Limited Page 4 of 6
The impact assessment report submitted under licensee return reference no. LR025785 as a response to the incident INCI0110045 was discussed. This report included an air dispersion model. The stack exit velocity parameter used in the air dispersion model was 14,260.3 m/s. The Agency queried this velocity parameter. Corrective action required: The licensee shall review and confirm the accuracy of the data used for the air dispersion model and where the data is incorrect, the licensee shall resubmit an amended assessment report. Site Visit Report - SV12567 - Takeda Ireland Limited Page 5 of 6
Summary The licensee breached ELVs for TA Luft Class II and TA Luft Class III organics at emission point reference no. EP-P1-03 on 11/05/2017 and 16/08/2017 respectively. The Agency opened a compliance investigation reference no. CI001533 in relation to the breaches and instructed the licensee to submit an impact assessment and investigation report. Previous incident reports concerning bypass events at the VOC recovery unit at emission point reference no. EP-P1-02 were evaluated and the licensee has implemented appropriate corrective actions. There hare been no bypass events at EP-P1-02 since 11/03/2016. s were made in relation to air emissions, abatement, monitoring and impact assessment, which will require corrective action by the licensee. FOLLOW-UP ACTIONS You are required to complete the instructions and actions, as outlined in this report, within the specified timeframe. Where required, you shall respond to actions specified in Investigations within the required timeframe.the licensee shall maintain documentary evidence, for review by the EPA, that the prescribed corrective actions were completed within the required timeframe. (i) Investigations You are not required to respond directly to items contained in this EPA site visit report; where an issue requires a direct response, the EPA will generate a Investigation through the EDEN system. You will receive notification when a Investigation instruction or action is generated. (ii) Publication of reports and licensee response. Please note that this Site Visit Report will be made available for public viewing via the EPA s Licence Enforcement Access Portal within one day of the issue date and will be published on the Licence Details Page of the EPA s website, www.epa.ie, that relates to your licence 60 calendar days after the issue date. You may if you choose submit, within 45 calendar days of the issue date of this Site Visit Report, a Licensee Public Response that will be published alongside the Site Visit Report. This Response, should you wish to avail of it, provides you with an opportunity to inform the public about how you are implementing the actions set out in the report, activities underway, timescales and target completion dates. Please be aware that the content of your Licensee Public Response must be factual and should not breach the EPAs stated online publication standards. If you wish to submit a Licensee Public Response to an EPA Site Visit Report, you should do this by clicking on the Make a Response link on the Site Visits page in EDEN. A.pdf document containing your response can be attached and submitted from here. (iii) Response to Site visit report Where you do wish to respond directly to a site visit report, you should do this by generating a Licensee Return of the type Site Updates/Notifications and the sub-type Response to EPA Report in EDEN. Please note that you are required to comply with the conditions of your licence at all times, and where noncompliance occurs you must restore compliance within the shortest possible time. These actions will be verified during subsequent EPA visits. Please quote the above Inspection Reference in any future correspondence in relation to this Report. Site Visit Report - SV12567 - Takeda Ireland Limited Page 6 of 6