WESTPORT, CO. MAYO, IRELAND.

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1 - c. ALLERCAN GEE PHARMACEUTICALS IRELAND TELEPHONE: TELEFAX: WEB SITE: WESTPORT, CO. MAYO, IRELAND. Office of Climate, Licensing & Resource Use, EPA Headquarters, P.O. Box 3000, Johnstown Castle Estate, Co. Wexford. Date: October 16th, 2008 Ref: IPPC licence PO Proposed Determination (PD) Dear Sir/ Madame, \ In accordance with Article 29 of the Environmental Protection Agency (Licensing) Regulations 1994 to 2004, Allergan Pharmaceuticals Ireland wish to lodge 11 objections to the Proposed Determination (Licence PO126-02) issued by the Agency on 24 September Please find attached details of the objections as well as the required fee of 253 to expedite the process. Name and Address of Objector: Allergan Pharrpaceuticals Ireland, Carrowbeg, Castlebar Road, Westport, Co. Mayo. Register Number: PO If you require further clarification in relation to any of the outlined objections please do not hesitate to contact me. Yours sincerely, EHS Manager DIRECTORS: Peter Flynn, Pat O'Donnell, Martin Gillen, Andy Cullen (British), David Endicott (US), Rajkumar Narayanan (Indian). Registered Dublin No. E Principal Place of Business: Castlebar Road, Westport, Co. Mayo V.A.T. No. IE 9Z68154 G. Company Registered in Cayman Islands No. CR

2 SUMMARY OF OBJECTIONS TO PROPOSED DETERMINATION (PD), LICENCE REGISTER NUMBER: PO Glossary of Terms and Condition 11.3 Regional Fisheries Board: the North Western Regional Fisheries Board is specified in the Glossary of Terms and Condition Allergan object to the naming of the North Western Fisheries Board in the licence Glossary of Terms and in Condition Allergan were advised by the Fisheries Board that any incidents relating to discharges to water must be notified to the Western Regional Fisheries Board. Allergan request that the Agency seek further clarification from the Regional Fisheries Board on the matter and amend the IPPCL PD accordingly. 2. Condition 3.5 The licensee shall clearly label and provide safe and permanent access to all on-site sampling and monitoring points and to ofs-site points as requested by the Agency. Allergan has no objection to the provision of safe and permanent access to all on site sampling and monitoring stations. However, we object to any imposition which would require Allergan to provide safe and permanent access to any off-site sampling and monitoring locations. Such locations would be outside Allergans ownership and control and we would in effect be trespassing on private property if we had to comply with an Agency request in this regard. Sampling and monitoring can take place on the public roadway (for example) adjacent to appropriate off-site environmental monitoring locations. 3. Condition 3.8 The licensee shall install and maintain silt traps and oil separators at the installation to ensure that storm water discharges from the installation pass through a silt trap and oil separator in advance of discharge. Installation of separators on storm water discharges not currently passed through a separator shall be completed within 18 months of date of grant of this licence. Any newly installed separators shall be Class I fill retention separators and the silt traps and separator shall be in accordance with EN-858-2: 2008 (separator systems for light liquids). Allergan has no objection to the provision of bypass separators on stormwater discharges from our site but consider that the requirement to provide full retention separators to be unreasonable and unrealistic. Full retention separators are normally specified in high risk spillage areas such as fuel distribution depots, vehicle 1

3 workshops and scrap yards. Bypass separators are normally specified where there is a risk of infrequent light contamination and potential for small spills, a situation which exists at the Allergan site. We respectfully request that the words full retention separators by replaced by the words bypass separators. 4. Condition 3.11 The provision of a catchment system to collect any leaks from flanges and valves of all overground pipes used to transport material other than water shall be examined. Allergan has no objection to carrying out a risk assessment of the overground pipe system used to transport materials other than water. However, we wish to point out that in general no hazardous materials are conveyed in the overground pipe system on the site. We respectfully suggest that Condition 3.11 be amended to the following: The licensee shall carry out a risk assessment of the over-ground pipe system within the site to determine if the over-ground pipe system, including flanges and valves poses an acceptable risk to the environment. 5. Condition 4.2 The concentration and volume flow limits for emissions to atmosphere specified in this licence shall be achieved without the introduction of dilution air and shall be based on gas volumes under standard conditions ofi In the case of non-combustion gases: Temperature 273K, Pressure kpa (no correction for oxygen or water content) In the case of combustion gases: Temperature 273K, Pressure kpa, dry gas; 3% oxygen for liquid and gasfuels, 6% oxygen for solidfuels. Allergan can see no reason to include Condition 4.2 in the JPPC licence as we have no emissions to air of environmental significance. We request that this condition be removed from the licence. 6. Condition 5.6 A programme and timescale for the diversion of canteen efluent from the process efluent drainage system and direct discharge to the Sanitary Authority sewer system shall be agreed with the Sanitary Authority prior to any direct discharge of canteen efluent taking place. Allergan object to Condition 5.6 as the term Sanitary Authority is not defined within the Glossary of Terms of the licence. Allergan requests that this term be defined in the Glossary of Terms. I 2

4 7. Condition 6.9 The integrity and water tightness of all underground pipes, tanks, bunding structures and containers and their resistance to penetration by water or other materials carried or stored therein shall be tested and demonstrated by the licensee prior to use. This testing shall be carried out by the licensee at least once every three years thereafter and reported to the Agency on each occasion. This testing shall be carried out in accordance with any guidance published by the Agency. A written record of all integrity tests and any maintenance or remedial work arising from them shall be maintained by the licensee. This condition is wholly unreasonable and penal in relation to the underground pipe network. Compliance with this condition would require that each section of the underground pipe regime including all process, foul and surface water drains, water mains, rising mains. etc would have to be isolated, in some cases the ends excavated and exposed and tested every three years. In order to do so, it would be necessary to suspend production and completely close the Allergan manufacturing facility for a minimum period of two weeks on each occasion. As an alternative to the testing of the underground pipe network we respectfully suggest that the licensee be required to carry out a camera survey of the underground surface water, foul sewer and process pipes every three years as is currently the case. 8. Schedule A: Limitations The following waste related processes are authorised: - Sterilisation (using an autoclave) of liquid and solid wastes generated in the Botox Plant - Heat treatment of process efjluent from the Botox plant prior to release to the process efluent drainage system. No additions to these processes are permitted unless agreed in advance with the Agency. Allergan objects to Schedule A: Limitations. In relation to the authorised waste related processes listed in Schedule A, we request that the Agency amends this section to include for the chemical treatment of process effluent from the Botox plant using sodium hypochlorite. This issue was advised to the Agency in Allergan s Response to Request for Additional Information submitted to the Agency on July 30th Condition 5.1; Schedule B.3 Emissions to Sewer Condition No specified emission from the installation shall exceed the emission limit values set out in Schedule B: Emission Limits of this licence. 3

5 Schedule B.3 - Emissions to Sewer - Emission Point Reference No: SE1 Parameter: Toxicity Emission Limit Value: 5 TU Allergan Objection: Allergan objects to the proposed Toxicity Emission Limit Value (ELV) of 5 TU. We propose that the limit be removed from the licence and if this objection is not accepted that the limit is increased significantly. Our challenge to the TU limit of 5 is set-out below:.. The toxicity test is a biological test and is subject to significant variability, inconsistency and subjectivity; We wish to point out that it will be difficult to consistently meet this limit value due to the inherent variations in biological indicators (i.e. the use of a. range of aquatic organisms); As the wastewater discharged from the Allergan plant is sent to sewer and to a modern biological tertiary treatment plant, Allergan request that the Toxicity Emission Limit Value (ELV) of 5 TU be removed or at the very least increased to 10TU or greater which is in accordance with the BAT Guidance Note on Best Available Techniques for Pharmaceutical and Other Speciality. Organic Chemicals ; We have also conducted a benchmarking exercise with other Pharmaceutical Companies and have determined that the majority operate to wither no limit or a much higher limit of 10 TU. 10. Condition 5.6; Schedule B.3 Emissions to Sewer Schedule B.3 - Emissions to Sewer - Emission Point Reference No: To be decided Parameter: Oils, fats & greases. Emission Limit Value: lmga Parameter: Temperature Emission Limit Value: 25 Centigrade Parameter: BOD Emission Limit Value: 300mgA Parameter: Detergents Emission Limit Value: 4mgA Allergan Objection: Allergan objects to the proposed emission limit value (ELV) of - lmg/l for Oils, Fats and Greases (FOG), 300mg/l for BOD, - 4mg/l for Detergents and to the limit of 4

6 - 25 Centigrade for Temperature as these limits are unattainable based on the effluent emitted from our on-site Canteen. Having considered this matter, Allergan propose that we install a grease trap on the effluent discharged from the Canteen and this effluent is directed to the on-site Balancing Tank and emitted as a single point discharge in accordance with current site arrangements. Having reviewed the data, an ELV of lmg/l for OFG goes far beyond the performance characteristics of industry standard grease traps. In addition, the proposed limit of lmg/l is far in excess of the limits referred to in the BAT Guidance Note on Best Available Techniques for Pharmaceutical and Other Speciality Organic Chemicals for discharges to water. We have also conducted a benchmarking exercise with other Pharmaceutical Companies and have determined that the majority operate to the higher limits ranging from 1Omg/l to 150mg/l. We respectfully suggest that the Emissions Limit Value be removed or if applied to emission point SE1 be increased from lmg/l to 50mg/l. The Emission Limit Value for BOD and Detergents for SE1 is 500mg/l and 5mg/l respectively. We therefore can see no logical reason why the IPPC licence has an Emission Limit Value of 300mg/l and 4mg/l for BOD and Detergents respectively for canteen effluent. We respectfully suggest that the canteen effluent be treated in the grease trap and discharged to the Balancing Tank with the proposed ELV s for SE1 applied. 11. Condition 6; Schedule C.6 Ambient Monitoring Groundwater Monitoring Schedule C.6 specifies a biannual frequency for the monitoring of groundwater. In addition the location refers to GW4a Allergan Objection: Allergan objects to the groundwater monitoring frequency being set at Biannually interval. Having benchmarked against other IPPCL companies and considering the excellent quality of the groundwater beneath the site, we respectfully request that the monitoring frequency be set at an annual interval. In addition, can you correct the typographical error and change GW4a to GW4. 5