OFFICE OF LICENSING & GUIDANCE

Transcription

1 OFFICE OF LICENSING & GUIDANCE INSPECTORS REPORT ON A LICENCE APPLICATION To: Directors From: MARIE O CONNOR - LICENSING UNIT Date: 19 April 2007 RE: Application for a Review of IPPC Licence from Cara Partners, Licence Register P Application Details Class of activity: Review application received 06 October 2006 Supplementary material submitted by applicant Class 5.16 the use of a chemical process for the production of basic pharmaceutical products 08 November 2006 Notices issued: 10 January 2007 Information received: 12 March 2007 Submissions received: None Site visits: 06 February 2007 Company Cara Partners are situated in Little Island Co. Cork on 8.6 hectares. They produce an extract of Ginkgo bilboa for pharmaceutical use via a multistep process involving extraction with solvents, evaporation and purification. They currently operate Monday to Saturday on the three-cycle shift basis but can operate a 24hr and 7 day system if required and employ ca. 100 people. They were granted an IPC licence Reg P on 04 August This review is required to bring it into compliance with the IPPC Directive. Process Description Ginkgo bilboa leaves are harvested mainly in China & France where a leaf with a high pharmaceutical active content is produced. The bales are shipped to Cork and stored in warehouses on site. The bales are then opened and conveyed by the 1

2 pneumatic conveying system to the reactors where solvent is added and the extraction of the API is carried out. The company also operates an integrated solvent recovery system where the used ethanol mixture is passed through a distillation/rectification column to produce clean ethanol for re-use in the process. Trade effluent is discharged to a Cork County Council sewer and is further treated in the Carrigrennan WWTP prior to discharge to Cork Harbour. Emissions to air arise from the Leaf preparation/dust extraction area, Carbon absorption units, ammonium sulphate dryer and two boilers. Specified solid and liquid wastes are sent for recovery either for composting or for landspreading. Use of Resources In 2005 the consumption of resources are reported as: Fuel 23,297 MWhr of Natural Gas Electricity 8,970 MWhr of electricity Water 42,000 m 3 Materials- The site uses a variety of solvents with the main ones being acetone, methyl ethyl ketone and ethanol. Lead acetate is also used on-site. IPPC Directive This installation falls within the scope of category 4.5 Installations using a chemical or biological process for the production of basic pharmaceutical products of Annex Ι of Council Directive 96/61/EC concerning integrated pollution prevention and control. The Proposed Determination (PD) as drafted takes account of the requirements of the Directive. In particular, it provides conditions dealing with water, energy and raw materials use, reduction and efficiency on site. BAT is taken to be represented by the guidance given in the EIPPCB reference documents on BAT and the BATNEEC Guidance Note for the Pharmaceutical Sector. Council Directive 1999/13/EC-Solvents Directive The processes carried out do not fall within the scope of EU Council Directive 1999/13/EC on the limitation of emission of volatile organic compounds due to the use of organic solvents in certain activities and installations. European Communities (Control of Major Accident Hazards involving Dangerous Substances) Regulations, 2006 (SI 74 of 2006) The licensee states in the application that the site is not classified as a Seveso site. The National Authority for Occupational Safety and Health (NAOSH) is the competent authority responsible for administration and enforcement of these regulations. Emissions Trading Directive (2003/87/EC) The installation is not covered by the scope of this directive. 2

3 Proposed Determination The RD takes into account the current licence and changes/improvements which have occurred on-site since Air: The main emissions to air arise from the boilers, carbon adsorption/desorption units and the leaf preparation areas. Two emission point have been decommissioned since the previous licence was granted The boilers (6 MW thermal input in total) are operated on natural gas and the licensee wishes to retain the option of using alternative fuels which is catered for in the RD. The ELV s specified in the previous licence for emissions from the boilers are removed as due to the size of the boilers it is considered that the limitations in regard to fuel type and annual maintenance and monitoring are sufficient. HEPA, dust and sintered filters are used for the abatement of emissions from the leaf preparation, conveying and drying systems and a carbon adsorption/desorption (CAU) system is used for abatement of solvent emissions as well as primary and secondary condensers. The emission limit values for EP 005 and EP 006 (CAU) are as per previous licence which are more stringent than BAT. The ammonium sulphate drying area is not currently operational however the licensee wishes to retain the emission point and ELV in accordance with the draft BAT Guidance Note for the sector are applied to allow for future projects. A test programme is required to be completed prior to the operation of this emission point. The ELV s for particulate and lead are retained in the PD and monitoring for pharmaceutical active is an additional requirement. The impact on the environment from these emissions is not considered significant. Emissions to Sewer: Process emissions are treated in an on-site central WWTP which consists of balancing tanks, an aeration tank and a clarifier. Wastewater from the lead process area is treated separately with the precipitation of lead and filtratation. The filtrate which will have trace levels of lead is sent to the WWTP and the precipitate is sent off-site for disposal. Domestic sewage is treated in septic tanks and further treated in the central WWTP. The discharge from the WWTP is sent to Cork County Council sewer and on-wards for treatment in the Carrigrennan Municipal WWTP. Consent conditions and changes requested to original licence limits have been agreed with the Sanitary Authority and incorporated into the RD. The discharge will have no significant impact on the Municipal WWTP inputs. Emissions to Waters: There are no direct discharges to water. Surface Water: Currently all surface water is diverted to the firewater containment system which then discharges to Ellis Basin. The RD requires the licensee to re-assess this so as to 3

4 provide adequate capacity at all times including the provision of an automatic diversion system. Trigger levels which were specified by OEE in their current licence for the diversion of the stormwater to the containment pond have been incorporated into the RD. Emissions to ground: Since the licence was issued in 1995 the licensee has undertaken an extensive hydrogeological investigation on-site. This indicated that there was contamination due to historical landspreading however this was not considered the primary source with other sources being leakages through bunds, tanker loading spillages and leakage from onsite drains and IDA drains as well as possible contributions from neighbouring sites. A 2006 survey indicated that the concentration of the majority of contaminants remain either within previously observed ranges or are decreasing. The location of 12 on-site monitoring wells were identified and it is proposed to continue the bi-annual monitoring at these locations. There is currently a groundwater pumping regime in place with the groundwater being discharged to the waste water treatment plant. The RD requires that the necessity for the continued treatment of the groundwater is examined given that groundwater is not utilised for potable or other supplies in the locality. Waste: All hazardous wastes such as lead filtrate, solvent wastes etc are sent off-site for disposal. The licensee carries out some solvent recovery operations on-site which are an integral part of the production process and not deemed a Class 11.1 activity. In addition an ammonium sulphate waste is sent to farmers for recovery by landspreading in accordance with a Nutrient Management Plan. Waste ginko leaves are sent to a permitted facility for composting. The RD includes conditions to control the landspreading operation to ensure compliance with the Nitrates Regulations (S.I. 378 of 2006). Cara Partners are in discussions with the Department of Agriculture to have the ammonium sulphate waste designated a low nutrient fertiliser in accordance with the standards set out in S.I. No. 248 of 1978 Marketing of non EEC fertilisers. Noise: Due to the location of the site within an Industrial Estate there are background noise sources e.g. busy road, industrial estate therefore previous studies have shown the levels at the boundary to be elevated. Since 1995 the licensee has carried out extensive work on the attenuation of the noise emissions from sources on-site. The RD proposes to set the limits at the noise sensitive locations in accordance with the EPA Guidance Note. Habitats The site is located on Little Island in an area zoned as an industrial estate. The operation of the activity in accordance with the RD will not impact on any designated area, the closest being Lough Mahon (Special Area of Conservation (SAC) Great Island Channel Site Code and Special Protection Area (SPA) - Cork Harbour SPA -Site Code: ) Environmental Impact Statement 4

5 There was no EIS submitted with this review which does not entail any changes to the operation of the site since the last planning permission was granted. Best Available Techniques (BAT) I have examined and assessed the application documentation and I am satisfied that the site, technologies and techniques specified in the application and as confirmed, modified or specified in the attached Recommended Decision comply with the requirements and principles of BAT. I consider the technologies and techniques as described in the application, in this report, and in the RD, to be the most effective in achieving a high general level of protection of the environment having regard - as may be relevant - to the way the facility is located, designed, built, managed, maintained, operated and decommissioned. Fit & Proper Person Assessment Cara Partners Limited Partnership was established by a deed of partnership dated 23 December 1977, reconstituted as a limited partnership by deed of 18 December 1978 and registered as such under the Limited Partnerships Act, 1907 on 27 February 1979 with registered number LP 34. The Partnership comprises of the following: (i) Wallingstown Company Limited (ii) Extracta Beteilingungs GmbH (iii) Societe de Conseils, de Recherches et d Applications Scientifiques (S.C.R.A.S.) (iv) BB ET CIE SAS (v) Perechin Company (vi) Montana Limited. The Partnership is represented by its general partner, Wallingstown Company Limited which is registered with the CRO (No ). Cara Partners Limited Partnership s experience, technical abilities, financial and legal standing would qualify it as Fit & Proper Person. Compliance Record: The compliance record of this site is good with the main issues being related to the historical contamination of the groundwater and the remedial actions being undertaken. There have been reported exceedences of ammonia and total nitrogen to sewer in 2007 however the increased limits allowed by the SA should cater for these excursions. Complaints: No complaints received. Submissions: No submissions, other than the Sanitary Authority consent to discharge to sewer, were received in relation to this review. 5

6 Charges: The proposed charge for invoicing for 2007 is 17, and the PD includes this charge as the review does not require any significant changes to reporting or monitoring by the Agency. Recommendation: I recommend that the Proposed Determination be issued subject to the conditions and for the reasons as drafted. Signed Marie O Connor Procedural Note In the event that no objections are received to the Proposed Determination of the application, a licence will be granted in accordance with Section 87(4) of the Environmental Protection Agency Act 1992 and 2003 as soon as may be. 6