The licensee shall take the actions specified to close out the non-compliances and observations raised in this Site Visit Report.

Transcription

1 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 Eli Lilly S.A. Eli Lilly S.A. Licence Register No. P CRO Site Address Site Visit Reference No. Dunderrow, Kinsale, Cork SV08295 Report Detail Issue Date 05/07/2016 Prepared By Martin O'Reilly Site Visit Detail Date Of Inspection 29/06/2016 Announced No Time In 09:15 Time Out 13:00 Agency Personnel On Site Martin O'Reilly Licensee Personnel and Role Mary Hamilton - Environmental Representative Charlie McGuinness - Environmental Specialist, Colette Relihan - EHS Team Leader Paul Walsh - Maintenance Planner. Photo Taken No Samples Taken No Video Taken No Site Visit Report - SV Eli Lilly S.A. Page 1 of 8

2 Scope This site visit was conducted as part of the EPA's routine annual site visit programme to assess licence compliance. Media The media examined were air, waste, and water. Site Areas Inspected Bunding, -hazardous waste storage area, Biofacility plant, IE30 Cooling towers, IE15 Drum store. Documents Inspected INAB scope of accreditation for ELS (Reg 111T), UKAS scope of accreditation for SAL (Reg 1181), INAB scope of accreditation for Glenside Environmental (Reg 322T), Procedure for effluent sampling KIN (31/05/2016), Waste collection permit for S Transport NWCPO , Indaver Antwerp waste facility licence MLAVI/ , Indaver Ireland waste licence W , Emissions to air monitoring (Anua and Glenside reports), Risk assessment on bunds and sumps procedure KIN-ED-003, Management of bunds on site procedure KIN-ED-006, Investigation reports for incidents INCI and INCI008950, Groundwater monitoring report December Site Visit Report - SV Eli Lilly S.A. Page 2 of 8

3 1. Health and Safety 1.1 Did the licensee make you aware of any site specific health and safety issues? Yes No No A safety induction video is given on arrival at the facility. The PPE requirements on site were safety footwear and safety glasses. 1.2 Was safe and permanent access to sampling/monitoring points provided? Yes 3.5 No No Site Visit Report - SV Eli Lilly S.A. Page 3 of 8

4 2. General laboratory management 2.1 If applicable, is the subcontracted laboratory used for compliance monitoring INAB accredited? Yes 6.6 No No The licensee uses ELS for subcontracted laboratory analysis. 2.2 If applicable, is the in-house laboratory, used for compliance monitoring, INAB accredited? Not Applicable No No All compliance monitoring is carried out by an external contract laboratory. 2.3 If accredited, does the scope of accreditation (in-house and subcontracted laboratory) cover all licensed parameters for compliance reporting? Yes No No The scope for ELS (Reg 111T) was reviewed and deemed to be satisfactory. Site Visit Report - SV Eli Lilly S.A. Page 4 of 8

5 3. Waste management 3.1 Of the waste types selected for review, were the EWC codes appropriate? Yes 11.8 No No The following EWC codes were reviewed and deemed to be appropriate: * Sodium Hydroxide, * halogenated solvent, * Solids waste contaminated with solvents and pharmaceutical residues. 3.2 Of the waste types selected for review, were the destination outlets authorised to accept those EWC codes? Yes 11.8 No No The destination outlets associated with the waste types were reviewed and deemed appropriate: * is sent to Indaver Ireland - Licence W , * is sent to Indaver Antwerp - Licence MLAVI/ , * is sent to Indaver Antwerp. 3.3 Of the waste types selected for review, were the hauliers/transport companies authorised to collect those EWC codes? Yes 11.8 No No The hauliers/transport companies associated with the waste types were reviewed and deemed appropriate: S Transport for all three wastes - NWCPO expires 07/06/ Has any waste been stored on site for longer than 6 months? No No No Site Visit Report - SV Eli Lilly S.A. Page 5 of 8

6 4. Air Monitoring 4.1 Have any ELV breaches been noted in air emissions monitoring in the last 12 months? No 5.1 No No Periodic monitoring reports were reviewed and deemed compliant. 4.2 If external contractors have undertaken air emissions monitoring in 2015 were they ISO accredited? Yes No No Glenside and Anua reports were reviewed and both were accredited for the monitoring carried out. Site Visit Report - SV Eli Lilly S.A. Page 6 of 8

7 5. Bunding 5.1 Have all bunds been integrity tested within the last 3 (or licence specific) years? Yes No Yes The licensee has carried out a risk assessment in line with section 5.2 of the Agency Guidance Note on the storage and transfer of materials for scheduled activities in order to determine the bunding requirements for materials storage. During the site tour an IBC of waste cooking oil was observed in the non hazardous waste compound. While the IBC was stored on a spilltray it was considered that the capacity of the tray was not sufficient to satisfy the licence requirement set out in Schedule The licensee has not carried out a risk assessment for bund requirements of waste cooking oil. At the IE30 cooling towers a number of mobile bunds were observed and were noted as not being uniquely identified. The licensee stated that a risk assessment had been carried out for these. Corrective Action Required The licensee shall carry out a risk a risk assessment in relation to the storage of waste cooking oil. In the event that the risk assessment indicates that material should be stored in a bunded area then the licensee shall ensure that such bunding complies with licence requirements in relation to capacity, inspection, and testing. A record of the risk assessment shall be maintained by the licensee and be available for inspection by Agency staff. In relation to the mobile bunds that are located at the IE30 cooling towers, the licensee shall ensure that these are uniquely identified and are included in the site bund inventory. The bund inventory should indicate if testing is required or not (based on appropriate risk assessment) and all such testing shall be in line with licence requirements and Agency guidance. You are required to take the above corrective action and to maintain documentary evidence of the action having been taken. The Agency may follow up on this matter at any time to ensure compliance with your licence. 5.2 Is all drainage from bunded areas treated as contaminated unless it can be demonstrated to be otherwise Yes No No The default is for discharge of bund water to the waste water treatment plant. In the event that checks carried out on bund water indicate that it may be contaminated then it is treated separately by appropriate means. Site Visit Report - SV Eli Lilly S.A. Page 7 of 8

8 Summary No non compliances were raised during the site visit. One observation, which requires action to be taken by the licensee, was raised and this related to bunding. 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. 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. 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, 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. 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 - SV Eli Lilly S.A. Page 8 of 8