Eli Lilly S.A., trading as Eli Lilly S.A. - Irish Branch Dunderrow, Kinsale, Co. Cork

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1 Office of Environmental Sustainability, E PA Head quarters, P.0 Box 3000 Johnstown Castle Estate, Co. Wexford Environmental Protection Agency 14 JUL 2016 Ref: ndustrial Emissions Licence Review (POOO9-04) Dear Sir/Madam, n accordance with Section 87(5) of the EPA Act 1992 as amended, we wish to lodge objection to certain conditions of the Proposed Determination (PD) for Licence Reg. No. POOO9-04, as issued by the Agency on 17th June Details of these objections are as outlined below; 1. Schedule B. 1 Emissions to Air The PD imposes new emission limit values (ELV) for Oxides of Nitrogen (as NOx) as follows; Pa rameter Units Half Hour Average Daily Average 1 A B Oxides of Nitrogen (NO and NO2 expressed as NO2) mg/m Note 6: Either, none of the half-hourly average values shall exceed any of the emission limit values set out in column A, or, 97% of the half-hourly average values over the year shall not exceed any of the emission limit values set out in column B. Obiection: The current licence (POOO9-03) NOx limit for the KEU incinerator (Emission Point Ref. A2-2) is based on a daily average ELV of 400 mg/m3 with no reference to half hour average compliance. The proposed daily ELV represents a 50% reduction in the existing limit. This was not envisaged, based on the supporting information provided in the grounds for objection below. The current NOx Selective Catalytic Reduction (SCR) device on the KEU is not capable of meeting these proposed limits therefore an adequate timeframe is required for the successful upgrade of this unit to maintain compliance to the proposed ELVs'. Grounds for Objection: The current KEU SCR was designed and installed over 10 years ago to meet licensing requirements at the time. As the current SCR is not capable of meeting the proposed limits on a consistent basis a realistic timeframe for upgrade of the unit should be incorporated into the PD. Such a timeframe has to account for the design, manufacture, supply, installation and testing of the unit. nstallation and testing also has to be scheduled during a period of least disruption to normal site operations. Taking all these factors into consideration a 2 year timeframe for upgrade completion is envisaged. n considering the proposed upgrade timeline it should be noted that the current licence limits are compliant with the ndustrial Emissions Directive (2010/75/EU), Annex V, Part 3, requirements for units with a nominal capacity of less than 6 tonnes per hour (KEU.= 3.1 tonnes/hour). t should also be noted that modelled NOx emissions, at existing emission limit values, from both existing and proposed emission points on site, demonstrated compliance to relevant air quality standards at and beyond the site boundary. Details of this modelling assessment are outlined in Attachment of the licence review application.

2 13th July 2016 Parameter Oxides of Nitrogen (NO and NO2 expressed as NO2) Units Half Hour Average Daily Average A B mg/m3 400 Note X 200 Note x 200 NoteX 400 Note Y 2. Schedule Cl. 1 Control of Emissions to Air O/o halogenated organic substances, expressed as chlorine Minimal thermal oxidiser operating temperature Minimum residence time Less than or equal to 1% Greater than 1% 85OoC llo0oc 2 second 2 second Obiection: The current licence (POOO9-03) makes no reference to operating temperature, residence time or feed stream chlorine content restrictions for the RTO. RTO technology, as applied to the treatment of process off gases, has traditionally been viewed as a VOC abatement process rather than an incineration process and has not been subject to the type of controls as outlined in this licence PD. The current RTO unit is not designed to operate at lloo C and is structurally not capable of providing a 2 second residence time in the combustion chamber therefore the unit would have to be completely replaced to achieve the operating controls as outlined in the PD. Grounds for Obiection: The proposed operating controls for the RTO, as outlined above, relate to those applicable to the incineration of solid or liauid waste as stipulated in the ndustrial Emissions Directive (2010/75/EU), Chapter V. The RTO unit does not manage solid or liquid waste, but vapours from manufacturing processes, therefore these controls are not appropriate in this instance. n addition to the fact that the ndustrial Emissions Directive (2010/75/EU) does not apply to the RTO, there are adequate controls in place for the RTO unit, based on its design and operation under the current licence. A commissioning test programme was completed on the RTO which demonstrated that the operating design conditions of 85OoC and residence time of 1 second was sufficient to achieve a destruction removal efficiency of 99.2% to 99.5% at expected feed concentrations for both halogenated and non-halogenated solvent vapours. Results of the test programme were reported to the Agency in Nov 2005 and were acknowledged by Agency response in Dec The RTO has continued to operate, at its design conditions, as an abatement device for both halogenated and non-halogenated process off gases for the lifetime of the current licence without any compliance issues. The average annual TOC and HC emission values for the RTO are consistently <5% of the ELV while dioxin values are consistently <lo% of the ELV. t should also be noted that the halogenated content of the process off gases is consistently <lolo (as chlorine) and it is not envisaged that the content of such gases should ever exceed 1%.

3 mposition of the proposed conditions would also have negative environmental impacts in that operating an RTO at lloo C would require substantial quantities of support fuel (gas) to maintain the higher bed temperature. This would also lead to increased emission of combustion gases (NOx, COZ), again leading to detrimental environmental impacts. Eli Lillv DroDosed amendment: For the reasons outlined above we consider the proposed operational controls unwarranted and request their removal from the PD. t is proposed that the RTO be allowed to continue to operate to its original design criteria, as tested and proven. 3. Schedule C2.2 Monitoring of Emissions to Water The PD imposes a new continuous online monitoring requirement fo SW1 as follows; TOC at Emission Point Ref. Control Parameter Monitoring Frequency Key Equipment/Technique TOC Continuous On-line TOC meter with recorder Objection: There is no requirement in the current licence (POOO9-03) to monitor TOC in effluent discharge on a continuous basis. As we do not currently have this capability available to us, the imposition of this condition, as currently written in the PD, will immediately place us in a state of noncom pl ia nce. Grounds for Objection: The continuous TOC monitoring of effluent discharge is considered unnecessary for the following reasons; Composite sampling is performed on effluent discharge over a 24H period, with resultant daily composites being analysed for COD seven days per week. The volume of final effluent holding tank (T36) is 680m3 with an automatic pump out range from 75% down to 60%. With an average daily effluent discharge of approximately 1200m3 the resulting numerous small volume pump outs over the day are considered representative of the mixed holding tank contents. All aqueous waste streams being processed through the Wastewater Treatment Plant are monitored from point of entry so as to eliminate the possibility of shock loading to the plant that could result in spikes in effluent COD/TOC. Eli Lillv DroDosed amendment: Removal of the requirement for continuous TOC monitoring of effluent discharge. COD monitoring of final effluent to be maintained as outlined above.

4 The fee of 253, as required under EPA licencing fee regulations, in relation to objections raised by the applicant or licensee, has been paid to the Agency's account by credit card. f you require further information or clarification in relation to the objections raised please do not hesitate to contact the undersigned. Yours faithfully, Charlie McGuinness Consultant HSE, Environmental Compliance

5 .. Noeleen Keavey From: Licensing Staff Sent: 14 July To : Noeleen Keavey Subject: FW: New Applicant objection entered for Reg no: POOO9-04. (Reference Number: POOO ) Attachments: POOO9-04 Licence 0bjection.docx mportance: High 1. ~ From: Charlie McGuinness J Sent: 14 July :41 To: Licensing Staff Subject: New Applicant objection entered for Reg no: POOO9-04. (Reference Number: POOO ) mportance: High Objection submitted on: 14/07/ :40 Title: Mr First Name: Charlie SurName: McGuinness Organisation E,i Li,ly S,A Name: Address Line 1: Dunderrow Address Line 2: Kinsale Address Line 3: County: Cork Post Code: Objector Type: Applicant - j Oral Hearing: No This has been scanned by the Symantec Security.cloud service. For more information please visit 1