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i This document has been cleared for submission to the Board bv the

I Programme Manager, Frank Clinton 9 Signed: @7 OKhavY Date: 05/02/2015 i P I

*:a TO: . Directors

FRbM: Tech n i ca I Co m m it t ee , - LICENSING%UNIT

DATE: 5 February 2015 . *

Objection t o Proposed Determination for Industr ial RE: Emissions Licence POl26-03 ALLERGAN

PHARMACEUTICALS 1 I RE LAN D

. ,. .X... .+ . . .. .. Class of actihy (First Schedule of EPA A d s 1992 to 2013): Category of activity under I E Di rective (20 10/75/EC) :

Location of activity:

Licence-application received:

PD issued:

First party objection received:

Comments received from Irish Water: Additional Information received:

5.16and 11.1 I . I,

4.5

Carrowbeg,'Castlebar Road, Westport, County Mayo.

10 December 2013

10 October 2014 .'

06 November 2014

16 December 2014

None . "

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Company

Allergan Pharmaceuticals Ireland (Allergan) has been operating in Westport since 1.977. The installation islocated on a 30 hectare site on the outskirts of Westport Town. The site is bounded to the south by the main Castlebar Road (N5), with a housing estate to the west, industrial units to the east and currently undeveloped land to the north. At present the installation employs approximately 860 people, with production operating 24 hours per day; 7 days per week.

Production activities a t the installation' consist mainly of pharmaceutical production (pharma plant), medical devices (Seriscaffold) and Botox production (Biologics plant). Associated warehouses, laboratories, office areas and maintenance facilities also occupy the existing plant area. Other support activities are carried on at the site including research and development, laboratories, engineering and administration.

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The licensee proposes-to increase Botox production capacity by the operation of a 2cd Biologics -facility (Biologics 11) at the installation. This will increase the plant‘s capacity for Botox production by approximately 160% and will allow Allergan to meet projected global demand in the long term. The extension to the Biologics plant will be accommodated on a 15.89 hectare site north of the existing facility. Operations at the proposed plant will be similar to those a t Biologics I, although on an increased scale.

Planning permission for Biologics I1 was received in November 2013 (Planning Ref: 12/451). An EIS was required for the planning application, and was submitted as part of the licence application. Biologics I1 is currently under construction and validation is scheduled to commence in early 2015, with operations sometime thereafter.

Consideration of the Objection The Technical Committee, comprising of Orla Harrington (Chair) and M6ire Buckley, has considered all of the issues raised in the objection and this report details the committee’s comments and recommendations following the examination of the objection and discussions with the inspector, Sean 0 Donoghue, who also provided comments on the points raised. The Technical Committee consulted with Agency Inspector John Gibbons (Office of Environmental Enforcement) in relation to compliance issues.

This report considers a first party objection, which in part related io Emissions to Sewer. Irish Water commented on these points of objection.

The main issues raised are summarised below. However the original objection and comments on the objections should be referred to a t all.times for greater detail and further expansion of particular points.

First Party. Objection

The licensee makes 11 points of objection and where relevant a number of points have been addressed under one heading. Irish Water’s responses to the First Party objection to emissions to sewer are dealt with in association with the objection to which they relate.

I . A.1. Condition 1.4 - Scope

Condition 1.4 states

No alteration to, or reconstruction in respect of, the activity, or any part thereof, that would, or is likely to, result in J

(i) a material change or increase in: . the nature or quantity of any emission; . the abatement/treatment or recovery systems; . the range of processes to be carried out;

the fuels; raw materials, intermediates, products or wastes 7 generated, or

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(ii) any changes in: ‘ - 1 .

site management, infrastructure or .control with adverse

shall be carried out or commenced without prior notice, to,. and without the agreement of, the Agency.

Allergan states that as part of their licence application they requested that the Agency include an exemption for Research & Development activities at the facility. Due to the nature of the installation incorporating R&D activities/ the materials used at the R&D facility will be subject to variation. Allergan ‘request an exemption to noti@ the EPA of changes to fuels/ raw materials/ intermediates/ products or wastes generated for R&D activities in the revised licence. Allergan requests the Agency to amend Condition 1.4 to include the proposed text ‘the fuels! raw materials/ intermediates, products or wastes generated (with the exception of those applicable to Research and Development activities)!.

environmental significance;

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Tech’nica I Com m ittee’s Eva I ua ti on : . . . ’

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The TC notes that an amendment to condition 1.4 was sought as part of the licence review application (POl26-03), for the removal of the requirement to notify the Agency of changes to fuels, raw material, intermediates, products or wastes generated for Research and development (R&D) activities at the installation. . -

The TC notes that condition 1.4 is a standard condition and is in the current

or obtain the agreement of the Agency in respect of changes in materials used, in

acknowledges the concern raised by the licensee in relation to the R&D plant and that the materials used in R&D are subject to continuous variation.

The TC agrees that condition 1.4 should take account of this variation allowing changes to fuels, raw materials, intermediates, products and wastes generated to occur only in relation to the R&D activities.

I licence (PO126-02). The condition requires the applicant to give prior notification

the R&D Department, which will by nature involve small quantities. The TC i r I

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1.4 No alteration to; or reconstruction in. respect of, the activity;-or any part thereof, that would, or is likely to, result in

(i) a material . change . . or increase in: . . - > *.-., *

the nature or quanti& of any emission; the abatementJCeatment o overysystems; ~ . the range of processesto b the fuels, raw materials, intermediates, products or wastes generated, (with the exception of those applicable to R&D activities) or

site management, infrastructure or control with adverse

shall be carried out or commenced without prior notice to, and without the aqreement of, the Aqency.

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I (ii) any changes in: ~ % I ‘A b

environmental significance;

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A.2. Condition 2.2.2.7 - Internal and External Audits

Condition 2.2.2.7 states

Internal and External Audits

The licensee shall establish and maintain a programme’ for independent (where practicable) internal and external audits of the EMS. Such audits shall be carried out at least once every three years. The audit programme shall determine whether or not the EMS is being implemented and maintained properly, and in accordance with the requirements of the licence. Audit reports and records of resultant corrective and preventative actions shall be maintained as part of the EMS in accordance with Condition 2.2.2.6.

Allergan has no objection to this licence condition; however they seek clarification on the term ‘independent: Internal audits are carried out by personnel who do not have ownersh@ of the Environmental Management System. Ekternal audits are carried out every 3 years by the Allergan Corporate EHS audit team who are independent of the Westport facility. The licensee hopes this is acceptable to the Agency as contracting the services of an external auditor would incur additional unnecessary expense.

Technical Committee’s Evaluation: .

An Environmental Management System (EMS) should include environmental audits and site assessments. The audits assess the use and application of the EMS, progress in relation to achievement of the stated environmental objectives, and compliance with regulatory issues. The audit enhances the credibility of the EMS by providing assurance that the management of the activity has regard to the desirability of ongoing assessment,‘ recording and reporting of matters affecting the environment.

The term independent refers to the independence of the internal or external auditor from parties that may be involved directly in the specific area of the business being audited. The concept requires the auditor to carry out his or her work freely and in an objective manner. The specific scope of Condition 2.2.2.7 can be discussed with the OEE Inspector if the licensee requires further clarification.

Recommendation: No change

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A.3 & A.4 Condition 6.12.1 and Condition 6.12.2 - Storm Water

Condition 6.12.1 states

Storm Water

A visual examination of the storm water discharges shall be carried out daily. A log of such inspections shall be maintained.

The licensee shall establish suitable trigger levels for pH in storm water discharges, such that storm waters exceeding these levels will be diverted for retention and suitable disposal. The licensee shall have regard to the Environmental Protection Agency “Guidance on the setting of trigger values for

Condition 6.12.2 states

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storm water discharges to off-site surface waters at EPA IPPC and Waste licensed facilities” when establishing the suitable trigger levels

Allergan considers it unnecessary to carry out this task on a daily basis. Due to the lack of incidents and low quantities of hazardous substances stored on site, the likelihood of storm water contamination is considered low. Allergan requests that thki requirement is changed from ‘Daily‘ to ‘Weekly‘

Allergan has no objections to establishing suitable tr@ger levels for pH in storm water “discharges. However Allergan objecis to the requirement to divert storm waters exceeding pH tr@ger levels for retention and suitable dsposal. mis is based on the low risk nature and low incident history of the site. Under PO126-02 Allergan is required to carry out monthly monitoring of pH and other parameters which they deem appropriate. The site does not have the capability to divert storm waters for retention and this would warrant significant investment.

Technical Committee’s Evaluation:

The TC notes that Schedule C.2.3 Monitoring Storm Water Emissions of the PD requires the licensee to monitor storm waters by visual inspection on a daily basis. The TC notes that Condition 6.12 of the current licence, PO126-02, requires weekly visual inspection of the storm water discharges.

Weekly examination of the surface water runoff from roofs and paved areas a t the site of the activity will be adequate, and a minor change to the wording of condition 6.12.1 will address this anomaly. The TC notes that Condition 6.7 of the PD provides adequate provision for the Agency to increase/decrease the frequency of sampling and analysis as necessary based on previous results.

The TC notes that the licensee has no objection to the setting of trigger levels for pH in storm water, however Allergan objects to the requirement to divert storm waters exceeding pH trigger levels for retention and suitable disposal. The Agency expects all relevant installations ‘to have appropriate and up to date trigger levels in place reinforced by on-going inspections, response programmes and appropriate maintenance of storm water management systems.

The TC notes from the Agency‘s ‘Guidance on the setting of tr9ger values for storm water dtscharges to off-site surface waters at EPA IPPC and Waste licensed facilities’, that “there is little point in putting warning and action levels in place for storm water monitoring, if they are not linked to a documented response programme for the achievement or exceedance of trigger level values. Readings at or in excess of an action limit shall require activation of the shut-off valve/diversion to the attenuation tanks, investigation of and notification of potential contamination of the discharge to the Agency”. The TC recommends that the condition refers to a documented response programme, in line with the Agency guidance. The TC recommends deleting the later part of the sentence, as regard should be had for the full Agency guidapce, not just the part relating to the establishment of the a trigger value.

The TC notes that diversion for suitable disposal will not be required if the licensee does not exceed the pH trigger levels. Any response programme will have to.be agreed in specific terms and that can be dealt with by the Agency OEE, as part of the enforcement of the licence.

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. < A.5. Condition 6.9 Pipeline Integrity Testing

Condition 6.9 states ' 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 for all such new structures. This testing shall be carried out by the licensee a t least once every three years, unless otherwise agreed by the Agency, 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.

Allergan objects to the condition 6.9 and requests a change in the wording to reflect our approved test-ng regime with the Agency for all underground pipelines including foul, process and storm water. Allergan request a change to include the following in Condition 6.9 'This testing shall be carried out by the licensee at least once evev three years thereafier or as agreed in writing with the Agency and reported to the Agency on each ocgasion'.

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Tech nica I Com m ittee's Eva I ua ti on :

This is, a standard Industrial Emissions (IE) licensing condition, which aims to control the. transfer and storage of potentially polluting substances and to ensure adequate protection of soils, surface waters and groundwater.

The TC is unclear as to the meaning of 'thereafter' in the context of condition 6.9. Condition 6.9 requires testing to be carried out a t least once every three years with the added flexibility of 'unless otherwise agreed with the Agency: Allergan received written approval from the EPA in relation to the frequency of drainage integrity testing. Following agreement with OEE, Allergan continue to monitor underground pipelines in accordance with this 'approved testing regime. The TC notes that condition 6.7 allows the Agency to increase the frequency of testing if it is deemed necessary, for example, based on examination of the reports on integrity and water tightness testing.

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As reported in the IR, a hydrogeological review was conducted in 2012 and the report was submitted with the licence application. A review of the historical groundwater monitoring results indicated historically elevated' levels for several parameters, including chloride, orthophosphate, VOCs, sVOCs and detergents, due to on or off site sources. The'onsite sources are believed to be from historical leakages from the process effluent drainage system.

The report concluded that remedial, measures taken on the process effluent drainage system in 2011 have removed the potential contamination source, but

. further monitoring is needed to confirm this. This incident highlights the importance of condition 6.9 (integrity testing). m e TC recommends no change

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to the wording of condition 6.9. * n 5 . ~ . - 4

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A.11 & A.6 & A.7 Condition 11.2 - notifications, records and reports, Condition 11.7 - Reporting to Irish Water, schedu/e 8.3 €. i s ions to Sewer. Condtion 11.2 states 1 -

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(iii) (iv)

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The licensee shall notify the'Agency by both telephone and either email or webform, to the Agency's headquarters in Wexford; or to such other Agency office as may be specified by the Agency, as soon as practicable after the occurrence of any of the following:

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an incident or accident that significantly affects the environment; any release of environmental significance to -atmosphere from any potential emissions point including bypasses; any breach of one or more of the conditions attached to this licence; any malfunction or breakdown of key control equipment or monitoring equipment set out in Schedule C: Control and Monitoring, of this licence which is likely to lead to loss of control of the abatement system; and any incident with the potential for environmental contamination of surface water or groundwater, or posing an environment threat to air or land, or requiring an emergency response by the Local Authority.

The licensee shall include as part of the notification, date and time of the incident, summary details of the occurrence, and where available, the steps taken to minimise any emissions. I

Condition 11.7 states I %

The licensee shall record all sampling, analyses, measurements, examinations, calibrations and maintenance' carried out in accordance with the requirements of this licence and all other such monitoring which relates to the environmental performance of the installation. A summary report (soft copy) of emissions to sewer shall be submitted to the Regional Wastewater Monitoring Compliance Liaison Specialist, Connaught 8t Ulster Region, Irish Water on a monthly basis.

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Allergan objects to hndition 11.2 which requires the licensee to noMy the Agency if there is any breach of one or more of the conditions attached to this licence. Allergan believe that this is unreasonable and would require them to report such items as a missing waste label. Allergan state that they operate a robust EMS and manage minor deviations from internal procedures. Allergan request that this condjtion be removed as it is impractical to implement. ,

Allergan objects to condition 11.7 as the requirement to submit a monthly'report tooIrish Water further increases the compliance and administration burden placed on the company. Allergan maintain an accurate and complete record of all sampling and sampling results carried out at the facility which is available for inspection at any time and is reported to the Agency as part of their Annual Environmental Report (AER).

Allergan objeects to the Schedule 8.3: Emissions to Sewer as the mass loadings (kg/day) for Detergents/ Mercury and Total P are lower than those specified in the submission to the Agency. To reflect the increase in daily volumes from the facility, Allergan request that the Agency increase these mass loadings to those outlined in the licence application.

Irish- Water's Resdonse:

Condition 11.7

Irish Water is agreeable to a reduction in reporting frequency and proposes an amendment to condition 11.7 which is outlined below. Schedule 6.3: Emissions to Sewer I $ 7 z

Irish Water does not propose any change to the limits outlined in the Section 99E response to the Agency. These limits provide protection to the Westport Wwrp and the resulting discharge to Clew Bay in the unlikely event of an elevated discharge of Mercury or Detergents in the Allergan effluent.

Tech n i ca I Com m ittee's Eva I ua t io n :

There is a legal mandate requiring the licensee to notify the Agency of any breaches in the conditions of the licence, and in particular, Section 86 (l)(a)(x) of the EPA Ads, as amended, which states that "conditions' attached to a licence or revised licence granted under this part shall specify, in the case of an industrial emissions directive activity, that where a breach of one or more of the conditions attached to the licence occuq the licensee shall without delay inform the Agency and take measures to restore compliance with condtions attached to the licence in the shortest possible time'! The current licence (PO126-02), was amended under Section 82A (11) of the EPA Ads, on the 18 December 2013 to bring the licence into conformity with ' the Industrial Emissions Directive. Amendments to the conditions of the' licence were necessary and included the text "The licensee shall not?@ the AgencK in a format as may be specified by the Agencyf without delay after: the occurrence of any breach of one or more of the conditions attached to this licence'!

Furthermore, the labelling of tanks, containers and drums to clearly indicate their contents is considered to be best practice and is already required under condition 3.6.5 of the PD. The specific scope of Condition 11.2 can be discussed with the OEE Inspector if the licensee requires further clarification. The TC recommends no change to this condition.

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Under Section 99E of the EPA Acts, as amended, where the Agency proposes to grant a licence which involves a discharge of any trade effluent to a sewer, it is required to obtain the consent of the sanitary authority in which the sewer is vested (Irish Water) or by which it is controlled. The TC considers that the licence should reflect the amended changes to condition, 11.7 as proposed by Irish Water.

With regard to the objection to mass loading limits specified under Schedule 53: Emissions to Sewer of the PD, the TC notes that the limits specified for detergents and mercury in the PD are as detailed by Irish Water in their response (letter dated 02 July 2014) to the Section 99E notice issued by the Agency. However the TC notes the limit for Total Phosphorus was not transposed correctly to the PD. Following consultation with the licensing inspector, the TC proposes to alter the limit for Total Phosphorus as detailed below to reflect the correction.

The Agency is not in a position to exercise discretion in setting limits other than those specified in the Section 99E response, unless the conditions being applied are more stringent than those set by the Sanitary Authority (Irish Water).

Rdcommendation: C o d

Amend Condition 11.7 as follows:

;11.7 The. licens,ee shalll record ) I

ed out in - accordance

report (soft copy) of emissions to sewer shall be submitted ,to the

directed to WasteWaterComplianceConnaughtUlster@water.ie.

Amend Schedule 63: Emkions to Sewer as follows:

B.3 Emissions to Sewer I .

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Emission Point Reference No: Name of Receiving Waters: Location: Outside main en6ance Volume to be emitted: . Maximuminanyone > 960,m3

SE1 (100489E, 285 143N) Clew Bay,*'via Westport Municipal WWTP

day: 1

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, Maximumrate per,; , I ~ 55m3 . I . hour:

35 OC ( m a ) 6 - 9

Temperature DH

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COD Detergents (as lauryl sulphate)

Total Residual Chlorine Mercury

Undenatured Botulinum Toxin

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A.8. Schedule C.2.3 Monitoring of Storm Water Emissions

Allergan objects to this Schedule as the Emission point reference numbers listed are incorrect. Allergan request3 the Agency to change these reference numbers to the following: SW1/2, SW3, SW4 and SWS.

Technical Committee’s Evaluation: The TC agree that SW1/2, SW3, SW4 and SW5 are the correct storm water emission point reference numbers, and

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A.9. Schedule C.6.1 Groundwater Monitoring

Allergan objects to Schedule C.6.1 as the footnote ‘Note 3‘ referenced under ‘Hazardous Compounds’ in the table is not listed at the end of the Schedule. Allergan request3 the Agency to claim this error.

Tech n ica I Com m ittee’s Eva I ua tion :

Following consultation with the inspector, the inclusion of a reference to Note 3 under ’Hazardous Compounds’ was a clerical error. The TC is satisfied that Note 2 is the correct footnote.

Recommendation: Amend Schedule C.6.1 Groundwater Monitoring by replacing ’Note 3’ referenced under Hazardous Compounds with ‘Note 2‘

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A.10. Schedule A: Limitations . , I

Schedule A: Limitations states

The following waste related processes are authorised:

- Sterilisation (using an autoclave) of liquid and solid wastes generated in the Biologics plants.

- Heat treatment of process effluent from the Biologics plants prior to release to the process effluent drainage system.

- Treatment of process effluent from the Biologics plants with sodium hypochlorite prior to release to the process effluent drainage system.

For the processes specified above, the combined capacity of the waste treatment processes shall not exceed 10 tonnes per day.No additions to these processes are permitted unless agreed in advance by the Agency.

Allergan object to point 1 under Schedule A: Limitations and requests a change in the wordjng to reffect our processes at the facility, Allergan requests the following text to be inserted: 'Sterilisation (using an autoclave) of liquid and solid waste generated at the facility: I ,

Technical Committee's Evaluation:

Agreed. However the TC consider it reasonable to replace 'biologics plants' with 'installation' as this is the term used in the EPA Acts, as amended and the Industrial Emissions Directive 2010/75/EU.

Amend point 1 under Schedule A;Limitations as follows":

Delete Biologics plants and replace with installation.

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Overall Recommendation

It is recommended that the Board of the Agency grant a licence to the applicant

(i) (ii)

for the reasons outlined in the proposed determination and subject to the conditions and reasons for same in the Proposed

subject to the amendments proposed in this report.

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Determination, , > and

(iii)

Signed i

Orla Harrington 1

for and on behalf of the Technical Committee * .

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