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TELEPHONE: +353-98-25222 TELEFAX: +353-98-25791 WEB SITE: www.allergan.com
PHARMACEUTICALS IRELAND WESTPORT, CO MAYO, IRELAND
Directors: Seamus Davey, Peter Flynn, Pat O’Donnell, Aileen Twomey Registered Dublin No. 514125 Registered Office Address: Castlebar Road, Westport, Co Mayo VAT No. IE 9839941 K
REQUEST FOR FURTHER INFORMATION
As requested by the Agency (EPA Letter dated July 9th
2014), please find below fuel, electricity and water data:
Table 1: Fuel and Electricity Usage 2012 & 2013
Energy Consumption
Energy type & units: 2012 2013
Heavy Fuel Oil N/A N/A
Light Fuel Oil (litres) delivered
Light Fuel Oil (litres) consumed*
26,694
36,994
32,518
41,335
Natural Gas (m3) 2,973,927 3,153,759
Electricity (kWh) 32,922,211 34,248,000
Liquified Petroleum Gas (LPG – litres) 15,706, 28,051
Table 2: Water Usage for 2012 & 2013
Water Consumption
2012 2013
On – site ground water None None
On – site surface water None None
From Mayo County Council supply – Water In 163,830,000 175,472,000
To Mayo County Council sewer, effluent
wastewater –Out
99,659,000 101,059,000
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Attachment A.1 - Non Technical Summary
This Industrial Emissions Activity (IEA) licence application is required to accommodate
significant changes to the Allergan Pharmaceuticals Ireland operations in Westport Co.
Mayo. Allergan have been granted planning permission to develop a second Biologics
facility on a 15.89 hectare site directly to the north of the existing facility as part of their
plans to increase BOTOX© production in the coming years in response to global demand.
The proposed expansion to the north of the existing facility will be dedicated predominantly
to a Biologics II building with production, warehousing and administrative areas. The area
will also accommodate an internal road network, a loading bay and car park.
The development of the Biologics II facility represents a substantial change to the existing
IPPC licence boundary and a material change to the site operation, and as such a licence
review is required to incorporate these changes to the licence. In addition, the principle
class of activity that applies to the Allergan operation (Class 5.16) requires that this licence
review is carried out under the European Union (Industrial Emissions) Regulation 2013.
As such, this licence application will seek to replace the existing IPPC licence, to
accommodate the changes to the site and will result in the granting of a new Industrial
Emissions Activities Licence for the complete site.
Technical Amendment B of IPPC licence P0126-02 was granted by the EPA on the 5th of
October 2012 to extend the IPPC licence site boundary to include an adjoining warehouse
and associated land at the north eastern corner of the site. This warehouse and associated
land have been acquired as an additional production facility to manufacture Allergan‟s
newest medical technology, SeriScaffold.
The licence application review will incorporate the following operational facilities:
Biologics I
Pharmaceutical Plant
Biologics II
SeriScaffold
A detailed review of the operation at the Allergan Pharmaceuticals Ireland facility was
undertaken. The unit operations and processes were examined.
The proposed operation of the Biologics II facility will be similar to the existing Biologics I
facility and will include compounding, filling and packaging production areas. As such there
is no change to the licensable activities, with operations falling within the scope of the
following classes of activity of the First Schedule of the EPA Acts 1992 to 2012:
Class 5.16 – “The use of a chemical process for the production of basic pharmaceutical
products”
Class 11.1 – “The recovery or disposal of waste in a facility, within the meaning of the Act
of 1996, which facility is connected or associated with another activity
specified in this Schedule in respect of which a licence or revised licence under
Part IV is in force or in respect of which a licence under the said Part is or will
be required”
Detailed process descriptions and process diagrams are provided in Attachment D of this
application.
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This non-technical summary contains the following information:
The relevant class or classes of activity in the First Schedule of the EPA Act 1992 as
amended,
Indication of whether EIS and planning permission documents are included,
Indicate relevant BAT guidance documents or BAT Conclusions decisions,
The title of the relevant BREF document
Information on how the emission limit values have been determined,
Indication if EC (Control of Major Accident Hazards involving Dangerous Substances)
Regulations 2006 apply,
If a derogation is being sought and the specific reasons for such derogation,
A description of:
the installation (plant, methods, processes, abatement, recovery and treatment
systems and operating procedures for the activity), with emphasis on the main measures
to avoid , reduce and, if possible offset the major adverse effects on the environment
the raw and auxiliary materials, substances, preparations, fuels and energy which
will be produced by or utilized in the activity,
the sources of emissions from the installation,
the environmental conditions of the site of the installation (e.g. soil and
groundwater, air, noise, surface water) including reference to a Baseline Report where
applicable,
the nature and quantities of existing and proposed emissions from the installation
into each medium as well as a summary of the assessment of the effects of the emissions
on the environment as a whole,
the proposed technology and other techniques to prevent or eliminate, or where
this is not practicable, limit, reduce or abate emissions from the installation,
summary of the quantity and nature of wastes which may be produced or accepted
at the installation,
measures to ensure that waste production is avoided in accordance with the waste
hierarchy in Council Directive 98/2008/EC on waste and section 21A of the Waste
Management Act 1996, as amended; where waste is generated, it is prepared for re-use,
recycled or recovered or, where that is technically and economically impossible, it is
disposed of while avoiding or reducing any impact on the environment (applicants should
provide this information in the context of the Waste Management Act 1996, as amended);
all the appropriate preventive measures are taken against pollution, in particular
through application of the Best Available Techniques (BAT) or BAT Conclusions Decision;
the necessary measures are to be taken under abnormal operating conditions,
including start up, shutdown, leaks, malfunctions, breakdowns and momentary stoppages;
the necessary measures to be taken on and following permanent cessation of
activities to avoid any risk of environmental pollution and return the site of the activity to
a satisfactory state or the state established in the baseline report if required;
measures planned to monitor emissions into the environment,
measures to comply with an environmental quality standard,
measures to comply with Council Directive 80/68/EEC and 2006/118/EC in relation to
the protection of groundwater,
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measures to be taken for minimizing pollution over long distances or outside the
territory of Ireland,
the main alternatives to the proposed technology, techniques and measures studied
by the applicant.
- key information
The relevant class or classes
of activity in the First
Schedule of the EPA Act 1992
as amended
5.16 The production of pharmaceutical products
including intermediates
11.1 The recovery or disposal of waste in a facility,
within the meaning of the Act of 1996, which facility is
connected or associated with another activity specified in
this Schedule in respect of which a licence or revised
licence under Part IV is in force or in respect of which a
licence under the said Part is or will be required.
Indication of whether EIS and
planning permission
documents are included
Planning Permission (Reference 12/451) has been granted
for the Biologics II facility.
The EIS and Appropriate Assessment addresses the
cumulative impact of the existing and proposed plants
and are included in this application.
Indicate relevant BAT
guidance documents or BAT
Conclusions decisions
The BAT Guidance Note for the Pharmaceuticals & Other
Specialty Organic Chemicals Sector
The title of the relevant
BREF document
BREF „Integrated Pollution Prevention Control (IPPC)
Reference Document on Best Available Techniques for the
Manufacture of Organic Fine Chemicals‟
Information on how the
emission limit values have
been determined
ELVs for Surface Water, Air and Noise are based on the
BAT Guidance.
ELVs for emissions to Sewer agreed with Mayo County
Council
Indication if EC (Control of
Major Accident Hazards
involving Dangerous
Substances) Regulations
2006 apply
Does not apply.
If a derogation is being
sought and the specific
reasons for such derogation
No derogations are sought but amendment to Condition
1.4 is being sought to allow for the removal of the
requirement to notify the EPA of changes to raw
materials, intermediates, products or wastes generated at
the R&D facility only is accounted for in the revised
licence.
- the installation (plant, methods, processes, abatement, recovery and
treatment systems and operating procedures for the activity), with emphasis on
the main measures to avoid , reduce and, if possible offset the major adverse
effects on the environment,
Allergan Pharmaceuticals Ireland is a technology-driven, global health care company
focused on specialty pharmaceutical products for specific disease areas that deliver value
to customers, satisfy unmet needs and improve patient lives. Allergan is situated in
Westport, and is a flagship manufacturing plant within the Allergan Corporation.
The existing Allergan plant, built in 1977, consists of a pharmaceutical plant in the north
of the existing site and the Biologics I plant in the south where BOTOX® and
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neurotherapy products are manufactured. Associated warehouses, laboratories, office
areas and maintenance facilities also occupy the existing plant area. A $56 million
extension to the Biologics I plant was completed in 2007 demonstrating the significant
and continuing investment that Allergan is making at the Westport facility.
Currently the activities at the Pharmaceutical Plant comprise of aseptic manufacture
(formulation) of all classes of ophthalmic preparations, including prescription drugs, and
ophthalmic surgery solutions. The facility also manufactures its own plastic bottles, tips
and caps to package the ophthalmic solutions produced. Sterilisation of the bottles is
achieved by external contractor sterilisation.
In addition, the Biologics I facility produces injections of BOTOX® which is used the
treatment of migraines, upper limb spasticity, eye muscle problems and for cosmetics
purposes.
Over the last number of years Allergan has expanded it‟s business model to include new
product development activities at the site, research and development, laboratory
development activities, cell culture and biotechnology activities.
Both the Biologics I and Pharma operation are covered by the IPPC licence (Register No.
P0126-01) which was granted in March 1997. This licence was subsequently reviewed in
June 2008 (P0126-02).
In 2012, an adjoining warehouse and associated land at the north eastern corner of the
site was purchased by Allergan Pharmaceuticals Ireland as an additional production
facility to manufacture Allergan‟s newest medical technology, SeriScaffold. SeriScaffold is
a bioresorbable silk-based surgical scaffold for use in tissue generation in numerous
therapeutic areas. The addition of the warehouse and associated land was incorporated
into the IPPC licence boundary by Technical Amendment B, which was granted by the
EPA on the 5th of October 2012.
To increase the capacity of the Allergan Pharmaceutical Ireland facility to manufacture
BOTOX®, an extension of the Biologics I facility will be accommodated on a 15.89
hectare site immediately to the north of the Biologics I and Pharmaceutical facility. The
proposed operation in the Biologics II facility will be similar to that in the existing
Biologics I facility and will include compounding, filling and packaging production areas.
Planning permission for the Biologics II facility has been granted by Mayo County Council
(Ref: 12/451).
The company operates a 3 shift cycle system, so that certain parts of the process are
operating 24 hours per day, seven days per week, however, most production
departments operate 24 hours per day, 5 days per week.
Allergan currently employs approximately 986 people.
For the majority of Allergan‟s operations, raw materials are taken onto the site; they are
then compounded and formulated, mixed, blended and filled into packaging containers,
which are warehoused on-site for distribution to customers worldwide. The plastic
container bottles, tips and caps are also manufactured at the Westport site.
The National grid reference for Allergan (12 digits 6N, 6E) is 100532E, 284990N.
The facility is located on a 30-hectare site and will consist of the following operational
areas; Biologics I and Pharmaceutical Plant (combined 10.5 hectare site), Biologics II
(15.89 hectare site) and the SeriScaffold plant. In addition there are associated
warehouse, maintenance, research and development facilities. A description of the
operations carried out at each of the operational areas is outlined in Attachment D.
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The following discrete manufacturing areas operate at the Westport facility:
Plastics
Multi Dose manufacturing
Unit Dose manufacturing
Ozurdex manufacturing
Seriscaffold – commissioning of the operation
Botox manufacturing
The processes carried out at the facility comprise primarily of:-
Raw material receiving
Plastics moulding operation
Compounding (formulation of solutions or solids)
Filling
Extrusion
Packaging
Warehousing
Shipping
A description of the unit process operations and the process flow diagrams are presented
in Attachment D. In addition, a description of the commercial products and process flow
are also provided in Attachment D.
In addition to the manufacturing activities, there are a number of support functions
carried out at the site. These support functions include: extensive Laboratories
(Microbiological, Chemistry, Cell Culture and Biotechnology), Maintenance, Research and
Development, Engineering, Validations, Financial Services, Administration and
Environmental Health and Safety (EHS). In addition there are two canteen facilities
located on-site to service the Pharmaceutical and Botox plants.
- the raw and auxiliary materials, substances, preparations, fuels and energy
which will be produced by or utilized in the activity
Active Pharmaceuticals, Steroids, Antibiotics and associated production materials are
used at the facility. A list of the compounds used in the manufacturing processes is
provided in Table G.1 (i) and (ii) of the application.
Due to the nature of the facility incorporating Research and Development facilities, the
materials used at the R&D facility will be subject to variation. Allergan Pharmaceuticals
Ireland request that the requirement to notify the EPA of changes to fuels, raw materials,
intermediates, products or wastes generated at the R&D facility only is accounted for in
the revised licence.
As such, Allergan wish to seek approval to change Condition 1.4 as follows;
the nature or quantity of any emission;
the abatement/treatment or recovery systems;
the range of processes to be carried out;
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the fuels, raw materials, intermediates, products or wastes generated (with the
exception of those applicable to Research and Development activities).
Hazardous materials used at the plant are stored both internally and externally in
designated, contained approved storage compounds in accordance with the appropriate
hazard classification.
All materials are transported around the site by either forktruck, pallet truck or trolley.
All personnel operating forktrucks are trained and certified. All personnel handling
chemicals are trained in chemical handling and spill response. The frequency of chemical
deliveries to the site is low.
All raw materials, work in progress and finished goods are stored in shippers or outer
containers, which clearly identify the contents by material number, batch, and the
quantity therein.
All non–production chemicals are taken to the Chemical Store (Pharma) for intermediate
storage. Laboratory solvents are taken directly to the relevant laboratory where they will
be stored in designated solvent storage containers.
With respect to the energy utilised in 2012 and 2013 details are provided in Table 1. All
boilers at the facility are fired from natural gas. Table 1 does not include projections for
the Biologics II facility or data for the Seriscaffold facility which will include additional gas
fired boilers in each plant.
Table 1: Energy Usage 2012 & 2013
Energy Consumption
Energy type & units: 2012 2013
Heavy Fuel Oil N/A N/A
Light Fuel Oil (litres) delivered
Light Fuel Oil (litres)
consumed*
26,694
36,994
32,518
41,335
Natural Gas (m3) 2,973,927 3,153,759
Electricity (kWh) 32,922,211 34,248,000
Liquified Petroleum Gas (LPG
– litres)
15,706, 28,051
The Total Raw Water use for 2012 & 2013 is shown in Table 2 (again only Biologics I and
Pharma operations are included). Of the water used on site, the majority of the water is
used in production departments for making up product batches, for clean in place and
steam in place processes. Water is also used in air handling units, chillers, laboratories
and the canteen. The process wastewater generated at the plant is discharged to the on-
site balancing tank and neutralization system for treatment and in turn is then pumped to
the sewer for final treatment in the Westport Wastewater Treatment Plant, which is
managed by Mayo County Council.
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Table 2: Water Usage for 2012 & 2013
Water Consumption
2012 2013
On – site ground water None None
On – site surface water None None
From Mayo County Council supply –
Water In
163,830,000 175,472,000
To Mayo County Council sewer,
effluent wastewater –Out
99,659,000 101,059,000
- the sources of emissions from the installation
Air Emissions
There are 3 no. boiler emission points (A1-1, A1-2 and A1-3) all of which are fired on
natural gas. In addition, the new Biologics II facility will have 2 no. boiler emission points,
fired on natural gas and which will be designated as A1-4 and A1-5. Other boilers are
classed as minor emissions.
There are no main air emission points of significance associated with the activity.
There are a number of minor emission points associated with the Allergan
Pharmaceuticals Ireland facility. These include stand-by generators, dust extraction and
fume hood extraction points. A number of the minor emissions are abated through the
use of HEPA filters or high efficiency filters, which remove process dust from the
contaminated air streams.
The main changes to the minor emission points since the previous licence application
review include a number of new minor emission points at the Biologics II facility, which
includes 2 diesel powered generators, Lab fume hood, an emergency generator and LPG
Burner at the SeriScaffold facility and 2 minor boilers at the Innovation Centre. In
addition there is an additional minor emission point associated with the Pharma re-
pelletisation, as agreed by the EPA (Ref: P0126-02(11)APR15MM.docx).
There are minor fugitive emissions from isopropyl alcohol and other alcohol-based sprays
used in the production areas but the amount is not significant.
The existing IPPC license does not require emissions monitoring at the boilers or any
minor emission point. The ongoing annual boiler efficiency programme will be
maintained.
It is not proposed to monitor at the minor emissions points, as the emissions are
negligible. This is because the areas, which the extract equipment services are generally
clean areas with infrequent use of the extraction equipment. Air filtration is employed in
these areas to ensure that re-circulated air is of sufficient purity. The condition of the
filtration equipment is constantly monitored and alarms are activated in the event of
deviation from ideal operating conditions.
The activities listed in Annex 1 of Council Directive 1999/13/EC on solvent use does not
apply to the facility. The solvents used on site are used for cleaning and in the clean
room areas.
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Under abnormal operating conditions (for example in the event of a fire at the plant) the
potential emissions include combustion emissions from the operation of two fire engines.
The amount is considered negligible.
Surface Water Emissions
Previously there were three licensed emissions points for surface water referred to as
SW1, SW2 and SW3. These are the outfall locations for the storm water (consisting of
run-off from paved areas such as car park and yard areas and internal road surfaces as
well as run-off from the loading bays and roofs), which is discharged to the small stream
located at the centre of the site.
Technical Amendment A of the IPPC licence P0126-02 was issued on the 7th of October
2010 in relation to Condition 3.8, the installation of by-pass separators on storm waster
discharges. To comply with Technical Amendment A, SW1 and SW2 were combined into a
new outfall (SW1/SW2 Combined) with an interceptor (Ref: Klargester NSBD130 Class 1
bypass interceptor). In addition an interceptor (Ref: Klargester NSBD030 Class 1 bypass
interceptor) was installed on the existing outfall SW3.
The current surface water outfalls, SW1/SW2 combined and SW3 are monitored on a
monthly basis. The mechanical sampler located at each outfall collects a composite
sample. In addition, samples are taken on a weekly basis for visual inspection.
In addition to the aforementioned outfall locations consisting of storm water from the
Biologics I and Pharmaceutical facilities, there will be an additional two outfall locations
discharging to the small stream through the centre of the site.
Storm water from the Biologics II facility will be discharged via emission point SW4, while
storm water from the SeriScaffold facility will be discharged via emission point SW5. The
storm water flows through an oil interceptor before discharge to the adjoining stream.
The location of these emission points are illustrated in Attachment E. Composite
samplers will be installed at the outfall locations and analysis carried out on a monthly
basis. In the event that analysis cannot be carried out on the composite samples due to
insufficient sample, it is proposed to take a grab sample at the outfall location following
wet weather.
Allergan Pharmaceuticals Ireland currently has one Mercury containing formulation on-
site. Allergan Pharmaceuticals Ireland will continue to monitor Mercury in Emissions to
Storm Water until such a time that mercury based raw materials have been phased out.
Allergan Pharmaceuticals Ireland will notify the EPA of the phasing out of Mercury based
raw materials and will notify the EPA of the intention to discontinue the requirement to
monitor for Mercury on a bi-monthly basis (6 sample per annum) as per Schedule C.2.3.
Results of monitoring of surface water discharges are reported to the EPA on an annual
basis as part of the Annual Environmental Report (AER) as required by the licence. There
are no emission limit values specified for surface water discharges in the current licence.
Emissions to Sewer
Process effluent from the Biologics, Pharma, Biologics II and SeriScaffold facilities is
treated in the on-site balancing tank and associated neutralisation system prior to
discharge to the Westport Town Wastewater Treatment Plant.
Emissions to the process drains consist of process washwater, distilled water from
compounding and filling process, wastewater from the laboratories, canteen, raw water
treatment system and cooling systems. Wastewater from Clean In Place (CIP)/Steam In
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Place (SIP) operating systems are discharged to the process drains and into the
balancing tank.
Wastewater from the toilet facilities and washbasins are discharged directly to foul sewer
by-passing the on-site balancing tank and effluent monitoring system.
Process water from the Botox operations at the Biologics I and Biologics II facilities
potentially contaminated with Botulinum toxin is denatured in-situ at the facilities, by
chemical treatment with sodium hypochlorite and/or heat treatment.
The process water from the Botox operations at Biologics I and Biologics II, may contain
very trace volumes of the Botulinium toxin. The only pathway for this contamination is
through the unlikely event of a vial rupturing in the process so the likelihood of
occurrence is very low.
Botox is a botulinal neurotoxin (BoNT) produced by vegetative cells of a Gram positive
anaerobic bacteria pathogen clostridium botulinum. The active neurotoxins formed
constitute a heavy chain (H, 100 kDa) and a light chain (L, 50 kDa) joined by an
interchain S-S disulphide bond. This interchain S-S bond plays a critical role in cell
penetration and its cleavage by reduction abolishes toxicity. This is how the toxin is
deactivated on the site through a series of heat treatments to break the bond.
All process water is treated in-situ prior to discharge to the process drainage system
before treatment to the on-site balancing tank. The toxin is treated through a series of
stages as follows:
In-situ treatment of the wash water in the Lyophilisers.
Denatuating of the toxin by autoclaving.
Directing the wash water to “kill tanks” where the contents of the tanks are raised
to 121 degrees centigrade for 15 minutes, prior to release to the process drainage
system.
Sink units where potentially contaminated equipment is rinsed are fitted with
dedicated storage tanks. Sodium Hypochlorite is added to these tanks to
inactivate the toxin prior to release to the process drainage system.
In relation to the process water from the Botox operation from Biologics I and Biologics II
facilities, Allergan Pharmaceuticals Ireland wish to apply to the EPA for permission to
reduce the temperature level required for heat treatment of process water from Biologics
I and Biologics II from 121ºC to 900C. Detailed technical information to support this
change is included in Attachment F.1. This information includes a literature review and
laboratory trials to demonstrate the efficiency of the treatment system at this reduced
temperature.
The treated effluent is discharged to the process drain and into the on-site balancing tank
for balance and neutralization prior to discharge at the designated emission point SE1,
where it is discharged to the Westport Town Wastewater treatment plant for treatment
(WWDA Register No. D0055-01). The final discharge is to Clew Bay.
The current monitoring programme for the emissions to sewer consists of on-line pH,
temperature and flow measurement with weekly flow proportionate composite samples
taken for analysis in accordance with the IPPC licence.
Due to the addition of Biologics II and the SeriScaffold operations, the discharge of
process water from the Allergan Pharmaceuticals Ireland facility will increase. The
discharge will be limited to an overall maximum of 960m3 in any one day. This is as per
agreement with Mayo County Council as specified in Condition 24 of Planning Consent
12/451 (refer Attachment B.6) for the Biologics II facility, which encompasses the
Biologics I, Pharmaceutical, Biologics II and SeriScaffold operational facilities. Due to the
increase in the maximum volume to be emitted, the mass loading of the Emission Limit
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Values has been increased to reflect the change in volume. These changes are outlined in
Table E.3 (ii) of the Application Form and Attachment I.3.
Wastewater from the toilet facilities, wash basins and canteen facilities are discharged
directly to foul sewer by-passing the on-site balancing tank and effluent monitoring
system.
Ground Emissions
No discharges to ground are associated with the manufacturing processes at the existing or
proposed Allergan facility.
There are currently 5 no. ambient groundwater monitoring wells within the boundary of the
site. 2 no. groundwater monitoring wells (GW1 and GW6) are located upgradient of the
facility, 1 no. groundwater monitoring well (GW3) is located within the Biologics I and
Pharma facilities and 2 no. groundwater monitoring well (GW4 and GW5) is located
downgradient of the Biologics I and Pharma facilities. A small stream running from east to
west across the land segregates the existing Biologics I and Pharma facilities from the
Biologics II facility and may act as a groundwater divide.
A comprehensive hydrogeological review of the facility was undertaken in 2012 with the
aim of developing a conceptual site model of the hydrogeological regime and undertaking
a risk assessment in relation to the underlying groundwater. The report concludes that
following a review of groundwater levels, flow direction and monitoring well locations the
existing monitoring wells do not provide suitable site coverage for the entire site. The
existing wells only provide coverage for the eastern and northeastern regions of the site.
This report is included in Attachment I.4.
In 2013, additional wells (GW5 and GW6) were installed to provide greater site coverage
particularly in the southern and western regions of the site. GW2 groundwater well was
decommissioned when the GW5 and GW6 were installed.
On completion of the construction of the Biologics II facility, Allergan Pharmaceuticals
Ireland will arrange for the completion of a hydrogeological investigation of the Biologics
II facility. The scope, detail and programme of the investigation will be agreed in advance
with the EPA prior to implementation.
Groundwater quality monitoring will continue on a biannual basis in accordance with
Schedule C.6 of IPPC Licence P0126-02 at GW1 and GW4.
Noise emissions
The primary existing noise sources are from the boiler house (N1) and the chiller units
(N2) located between the Biologics I and Pharmaceutical facility. There has been
significant noise abatement works carried out at the plant over recent years and the
plant is operating within the terms and conditions outlined in the current IPPC Licence
P0126-02.
With regard to the Boiler house and Chiller Area, the following works have been
completed. The original boiler house doors have been replaced by purpose built louvered
acoustic doors, which consists of a double acoustic metal door construction complete with
frame, giving a Rw of 48.8dB. The timber gate enclosing the chiller area, has been
upgraded, and is now a complete surface with no gaps, the gate now runs down to the
ground surface, and no longer has a significant gap between the ground and the base of
the gate. This gate is also now kept closed at all times save of access/egress.
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The 2012 Environmental Noise Report is provided in Attachment I.7 and concludes that
the Allergan Pharmaceuticals Ireland facility is operating within the IPPC noise emission
limits as identified for the facility in IPPC License Number P0126-02.
Due to the addition of the Biologics II facility to the IPPC Licence boundary, an additional
noise sensitive location will be required to assess the noise impact of site operations on
residential receptors to the north of the Biologics II facility. A residential receptor (NSL4)
has been identified to the north of the site and it is proposed that this additional location
will be included in the annual noise survey as per Condition 6.13 of IPPC Licence.
Due to the impact of the traffic noise on the noise sensitive locations (as identified in the
2012 Annual Environmental Noise Report) it is requested that there is no change to noise
limit values for ambient noise as specified in Schedule B.4 of IPPC Licence P0126-02.
the environmental conditions of the site of the installation (e.g. soil and
groundwater, air, noise, surface water) including reference to a Baseline
Report where applicable,
The existing environment and the impact of the activity is outlined in further detail in
Attachment I.
Soil and groundwater: The Dinantian and Pure bedded Limestones underlying the site
are likely to have good aquifer potential and are classified as regionally important
aquifers. The Dalradian rocks to the south of the site are considered to have poor aquifer
potential and are classified as Poor Aquifer.
Air: The location of the facility is on the outskirts of Westport. There is no routine
monitoring of air quality carried out in the Westport area by the EPA or Mayo County
Council. Monitoring has been carried out in Castlebar by the EPA since 2009 and PM10,
ozone and nitrogen oxides are measured. Given the similarity of the locations, the
Castlebar data is considered representative and was used and presented as background
air quality in this assessment for the proposed impact of the Biologics II facility on air
quality. The results of the Allergan Pharmaceuticals Ireland facility will remain within the
statutory ambient limits for the protection of human health at the proposed development
site boundary.
The impact of the facility on local air quality over the lifetime to date has been negligible
with no recorded complaints for odour or other air emission issues.
Noise: Noise sources in the area include a number of commercial operations, residential
activity and road traffic, primarily on the N5 Castlebar to Westport Road. The 2012
Annual Environmental Noise Monitoring Report, which is presented in this application, has
concluded that the primary noise source in the area is the traffic.
Surface Water: The surface water enters a small stream which separates the site. The
surface water catchment area, Carrownisky-Owenwee-Carrowbeg-Coastal extends east of
Allergan and then runs north and west of Westport town before discharging into the sea.
The Carrowbeg River has a Q value of 3-4. Surface water emissions at the Allergan
facility are unlikely to impact significantly on surface water downstream. This can be
demonstrated by the surface water monitoring results for the discharge to the stream
recorded over recent years.
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- the nature and quantities of existing and proposed emissions from the
installation into each medium as well as a summary of the assessment of the
effects of the emissions on the environment as a whole.
Soil and groundwater: There will be no emissions to groundwater or soil at the
Allergan facility.
Air: Air emissions will be primarily from combustion sources, i.e. the boilers and stand-
by generators. All boilers are fuelled by natural gas, which is a cleaner fuel with a
reduced environmental impact. There are 3 existing boilers at the Pharmaceutical Plant.
Although there are three boilers at the facility, a maximum of two is operational at any
time. In addition there are 2 new boilers at the Biologics II facility. There are also small
boilers located in the Seriscaffold building and at the Innovation Centre.
There are a number of stand-by generators and small boilers at Biologics I,
Pharmaceutical, Biologics II and SeriScaffold facilities, which are used in case of
emergency except for one generator, which is run as part of the ESB winter peak demand
reduction programme (this generator operates for approximately 190 hours per year).
The cumulative impact of the boilers and generator on air quality is not considered
significant.
Sewer emissions: Process emissions from the Allergan Pharmaceuticals Ireland facility
will continue to be routed to the effluent treatment facility (balancing and neutralization
process) prior to discharge to the Westport Wastewater Treatment Plant. In the event
that significant alterations to quantities or nature of emissions to sewer are likely, the
EPA and the Sanitary Authority will be notified.
Surface Water: Discharge to surface water is currently via two surface water drains
designated SW1/SW2 combined and SW3. In addition, the Biologics II facility will have
an outfall location designated SW4 and the SeriScaffold facility will have an outfall
location designated SW5. It is not anticipated that additional emissions other than those
outlined above will occur.
-the proposed technology and other techniques to prevent or eliminate, where
this is not possible, limit, reduce or abate emissions from the installation.
Allergan Pharmaceuticals Ireland strives to ensure that there is no significant impact on
the environment from operations at the facility. The existing technology and techniques
used at the facility are implemented with minimal impact on the local environment.
Allergan Pharmaceuticals Ireland is BAT compliant with respect to the operational
controls and procedures in place at the facility and in relation to the environmental
emissions levels associated with the facility.
The proposed Biologics II facility was subject to an Environmental Impact Statement to
ensure that the impact of the Biologics II facility on the environment is minimal. Details
of Environmental Consideration and BAT are outlined in Attachment I.8.
- summary of the quantity and nature of wastes which may be produced or
accepted at the installation.
Both hazardous and non-hazardous wastes are generated at the facility. Details of all
waste materials are provided in Tables H.1(i) (hazardous) and H.1(ii) (non-hazardous) in
the main application document, and include information in relation to the sources of the
waste, the quantity of waste generated, and on- and off-site recovery/disposal/re-
use/recycling.
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Hazardous wastes produced at the facility include waste oils, chemical waste (solvent and
aqueous), contaminated packaging, used batteries and used fluorescent tubes.
Approximately 51.6 tonnes of hazardous waste were produced at the site in 2012.
Non hazardous wastes include metals, paper, cardboard, wood, glass, plastics and food
waste. Approximately 1,428.2 tonnes of non-hazardous waste were produced at the site
in 2012.
- measures to ensure that waste production is avoided in accordance with the
waste hierarchy in Council Directive 98/2008/EC on waste and section 21A of the
Waste Management Act 1996, as amended; where waste is generated, it is
prepared for re-use, recycled or recovered or, where that is technically and
economically impossible, it is disposed of while avoiding or reducing any impact
on the environment (applicants should provide this information in the context of
the Waste Management Act 1996, as amended).
Allergan Pharmaceuticals Ireland minimise waste generation through the implementation
of the waste hierarchy and the implementation of measures as part of the EMS. Allergan
Pharmaceuticals Ireland will strive to continue to prevent, reduce and where possible
reuse waste.
Hazardous waste from the Botox operation at the Biologics I facility is either chemically
treated or autoclaved prior to disposal. Liquid waste from the autoclaving process is
routed to a holding tank where it is either treated with sodium hypochlorite or heat
treated prior to discharge to the on-site balancing tank. Solid waste from the Botox
autoclaving process is dispatched for disposal by incineration off-site.
In 2012, the rate of recycling recorded at the facility was 93.25% (96.02% for non-
hazardous streams).
- all the appropriate preventive measures are taken against pollution, in
particular through application of the Best Available Techniques (BAT) or BAT
Conclusions Decision;
A BAT assessment has been carried out for operations at Allergan Pharmaceuticals
Ireland facility. The BAT assessment is presented in Attachment I.8.
Allergan Pharmaceuticals Ireland has adhered to the licence requirements of the current
IPPC licence, P0126-02. Emissions to atmosphere, surface water, sewer and noise are
monitored and assessed as part of the licence. Operations at the facility have not
resulted in any significant pollution and Allergan will continue to operate in such a
manner that no significant pollution will occur.
Allergan Pharmaceuticals Ireland is committed at a site and corporate level to energy
conservation. An Energy Conservation team has been formed in the last 3 years at the
facility with participating members from the EHS, Maintenance, Engineering, Operations
and Facilities Departments. The aim of this team is to identify and where feasible,
implement any energy conservation opportunities across the site as well as educating
and promoting energy awareness among employees. The Energy Team also develops and
implements annual energy conservation targets and action plans. This team meets
regularly during the year to review the status of various projects. Energy conservation
projects are included as part of the Allergan Environmental Management Plan submitted
to the EPA as part of the Annual Environmental Report.
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In 2011, following an audit, Allergan successfully obtained certification to the ISO50001
Energy Management Standard which was previously known as EN16001. Currently,
Allergan adheres to the principles of IS050001.
There is an Emergency Response Plan in place at Allergan. The primary aim of the
emergency response plan is to protect human life at risk from any emergency and to
prevent injury. The plan also aims to protect the environment from pollution and the
plant and its contents. The aim in all cases is to prevent emergencies arising by good
preventative measures and in cases of an emergency to direct efforts at prevention of
escalation of emergency. The basis of the plan is to provide a rapid response to the
incident by the highly trained emergency response teams comprising of the Coordinated
Emergency Response Team (CERT) and the Plant Emergency Organisation (PEO).
A report on Firewater Retention and fire risk at the facility was carried out in 1998 and
concluded that the fire risk is very low and the risk of water contamination is low.
Technical Amendment B of IPPC Licence P0126-02 amended Condition 3.9 to review the
firewater risk assessment, to assess the impact of including the additional lands and
buildings related to the SeriScaffold facility within 6 months of the date of grant of the
Technical Amendment. The firewater risk assessment was revised in September 2012 to
take account of the Biologics II facility and the SeriScaffold facility. This revised
assessment concluded that the risk of fire is considered low.
Allergan Pharmaceutical Ireland commit to providing required finances and sufficient
resources to fully decommission the site in the event of closure, including to render safe
or remove for disposal/recovery, any soil, subsoils, buildings, plant or equipment, or any
waste, materials or substances or other matter container therein or thereon that may
result in environmental pollution.
Allergan Pharmaceutical Ireland will adhere to the EPA „Guidance on Environmental
Liability Risk Assessment, Residuals Management Plans and Financial Provision‟ 2006, and
any future updates in the event of closure or partial closure of site operations and will
engage fully with the EPA on all aspects of decommissioning operations.
A Residual Management Plan (CRAMP) to fully detail the arrangements and costs for site
decommissioning or closure or part thereof was prepared and submitted to the EPA in
March 2013.
Allergan Pharmaceuticals Ireland will comply with requests to complete such reports and
will review as necessary to reflect any significant changes on site and in accordance with
the conditions of the IPPC licence.
- the necessary measures are to be taken under abnormal operating conditions,
including start up, shutdown, leaks, malfunctions, breakdowns and momentary
stoppages;
The principle pollutant of concern from the Allergan facility is the potentially presence of
Botulinum toxin in the process water. The vessels that are exposed to the Botulinum
toxin are treated in situ using heat and/or chemical treatment. The treatment in situ
allows for the isolation and capture of all potentially contaminated waters thereby
negating any potential for discharges from abnormal, start up or shut down operations.
All other emissions are relatively inert (natural gas boilers and storm discharges) and
hence the potential for discharges from abnormal, start up or shut down operations is
limited.
- measures planned to monitor emissions into the environment
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Allergan Pharmaceutical Ireland carries out monitoring in accordance with the
requirements of the IPPC Licence P0126-02. Where changes are requested or additional
monitoring locations have been deemed necessary for the review application, these are
outlined and summarised below:
Condition 1 - Scope
Due to the nature of the facility incorporating Research and Development facilities, the
materials used at the R&D facility will be subject to variation. Allergan Pharmaceuticals
Ireland request that the requirement to notify the EPA of changes to fuels, raw materials,
intermediates, products or wastes generated at the R&D facility only is accounted for in
the revised licence.
As such, Allergan wish to seek approval to change Condition 1.4 as follows;
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 generated (with the
exception of those applicable to Research and Development activities).
Condition 6.9 – Integrity and water tightness testing of Underground pipelines,
Condition 6.9 of the IPPC Licence P0126-02 requires integrity and water tightness of all
underground pipes. The condition further states that the testing shall be carried out by
the licensee at least once every three years thereafter and reported to the Agency on
each occasion.
Allergan Pharmaceuticals has a written agreement in place with the EPA on the frequency
of drainage integrity testing. Allergan Pharmaceuticals Ireland will continue to monitor
underground pipelines in accordance with the frequencies previously agreed with the EPA
(Ref: P0126-02(12)APR17MM.docx).
System Proposed Pressure Test
Frequency
Proposed CCTV
Frequency
Process Drainage 5 years 3 years
Foul Drainage 7 years 5 years
Storm Drainage N/A – CCTV only 5 years
It is proposed to extend this monitoring schedule and testing methodology to the
SeriScaffold and Biologics II facilities.
Schedule A – Limitations
In relation to the process water from the Botox operation from Biologics I and Biologics II
facilities, Allergan Pharmaceuticals Ireland wish to apply to the EPA for permission to
reduce the temperature level required for heat treatment of process water from Biologics
I and Biologics II from 121ºC to 900C. Detailed technical information to support this
change is included in Attachment F.1. This information includes a literature review and
laboratory trials to demonstrate the efficiency of the treatment system at this reduced
temperature.
Emissions to Atmosphere
There are no main emissions to atmosphere and as such no monitoring is required.
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There are a number of minor emissions to atmosphere including stand-by generators,
dust extraction and fume hood extraction points. A number of the minor emissions are
abated through the use of HEPA filters or high efficiency filters, which remove process
dust from the contaminated air streams. It is not proposed to carry out monitoring at the
minor emission points as the emissions are considered negligible.
There are a number of boiler emission points (7), all of which are considered minor
emission points (i.e. less than 5MW). The existing IPPC license does not require
emissions monitoring at the boilers or any minor emission point. An ongoing annual
boiler efficiency programme will be implemented and maintained.
Emissions to Surface Water
There will be a total of 4 no. storm water outfall locations, which discharge
uncontaminated stormwater to the small stream through the centre of the site.
Composite samplers are in-situ at SW1/SW2 combined and SW3. It is proposed that
composite samplers are installed at SW4 and SW5 to monitor the surface water
discharges to the stream. Samples will be collected from the composite samplers on a
monthly basis for the parameters outlined in Tables F.2(i) Emissions Monitoring &
Sampling Points. In addition samples are collected on a weekly basis for visual inspection
in accordance with Condition 6.12 of the IPPC Licence.
Allergan Pharmaceuticals Ireland currently has one Mercury containing formulation.
Allergan Pharmaceuticals Ireland will continue to monitor Mercury in Emissions to Storm
Water until such a time that Mercury based raw materials have been phased out.
Allergan Pharmaceuticals Ireland will notify the EPA of the phasing out of Mercury based
raw materials and will notify the EPA of the intention to discontinue the requirement to
monitor for Mercury on a bi-monthly basis (6 sample per annum) as per Schedule C.2.3.
In the event that analysis cannot be carried out on the composite samples due to
insufficient sample, it is proposed to take a grab sample at the outfall location following
wet weather.
Emissions to Sewer
The process water from Biologics I, Biologics II, Pharma and the SeriScaffold facilities are
routed to the existing balancing tank for balance and equalisation prior to discharge at
the designated emission point SE1.
The current monitoring programme for the emissions to sewer consists of on-line pH,
temperature and flow measurement with weekly flow proportionate composite samples
taken for analysis in accordance with Schedule C.3.2 of IPPC Licence P0126-02.
Allergan Pharmaceuticals Ireland currently has one Mercury containing formulation.
Allergan Pharmaceuticals Ireland will continue to monitor Mercury in Emissions to Sewer
until such a time that Mercury based raw materials have been phased out. Allergan
Pharmaceuticals Ireland will notify the EPA of the phasing out of Mercury based raw
materials and will notify the EPA of the intention to discontinue the requirement to
monitor for Mercury on a monthly basis as per Schedule C.3.2.
Due to the addition of Biologics II and the SeriScaffold operations, the discharge of
process water from the Allergan Pharmaceuticals Ireland facility will increase. The
discharge will be limited to an overall maximum of 960m3 in any one day. This is as per
agreement with Mayo County Council in relation to Condition 24 of Planning Consent
12/451 for the Allergan Pharmaceuticals Ireland facility, which encompasses the Biologics
I, Pharmaceutical, Biologics II and SeriScaffold operational facilities. Due to the increase
in the maximum volume to be emitted, the mass loading of the Emission Limit Values has
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been increased to reflect the change in volume. These changes are outlined in Table E.3
(ii) of the Application Form and Attachment I.3.
Emissions to Ground
Groundwater quality monitoring will continue on a biannual basis in accordance with
Schedule C.6 of IPPC Licence P0126-02 at GW1, GW3, GW4, GW5 and GW6.
GW2 was decommissioneding in agreement with the EPA. On completion of the
construction of the Biologics II facility, Allergan Pharmaceuticals Ireland will arrange for
the completion of a hydrogeological investigation of the Biologics II facility. The scope,
detail and programme of the investigation will be agreed in advance with the EPA prior to
implementation.
Noise Emissions
Noise Monitoring will be carried out at N1 and N2, the on-site noise emissions in
accordance with the parameters, monitoring frequency and analysis method as outlined
in Tables F.2(i) Emissions Monitoring & Sampling Points.
In addition, noise monitoring will be carried out at the on-site boundary locations N3 to
N6 in accordance with the parameters, monitoring frequency and analysis method as
outlined in Tables F.2(i) Emissions Monitoring & Sampling Points.
There are currently 3 noise sensitive locations, designated NSL1, NSL2 and NSL3. Noise
monitoring will be carried out in accordance with the parameters, monitoring frequency
and analysis method as outlined in Tables F.2(i) Emissions Monitoring & Sampling Points.
Due to the addition of the Biologics II facility to the IPPC Licence boundary, an additional
noise sensitive location will be required to assess the noise impact of site operations on
residential receptors to the north of the Biologics II facility. A residential receptor (NSL4)
has been identified to the north of the site and it is proposed that this additional location
will be included in the annual noise survey as per Condition 6.13 of IPPC Licence.
- the necessary measures to be taken on and following permanent cessation of
activities to avoid any risk of environmental pollution and return the site of the
activity to a satisfactory state or the state established in the baseline report if
required.
Allergan Pharmaceuticals Ireland commit to providing required finances and sufficient
resources to fully decommission the site in the event of closure, including to render safe
or remove for disposal/recovery, any soil, subsoils, buildings, plant or equipment, or any
waste, materials or substances or other matter container therein or thereon that may
result in environmental pollution.
Allergan Pharmaceutical Ireland will adhere to the EPA „Guidance on Environmental
Liability Risk Assessment, Residuals Management Plans and Financial Provision‟ 2006, or
any future guidance (such as the 2013 revised draft guidance), in the event of closure or
partial closure of site operations and will engage fully with the EPA on all aspects of
decommissioning operations. A Residual Management Plan detailing the arrangements
and costs for site decommissioning or closure have been prepared for the site as
requested by the EPA. Copies of same have been issued to the Office of Environmental
Enforcement in March 2013.
- measures to comply with an environmental quality standard.
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Section L of the application form provides details of the Allergan operation and measures
to comply with environmental standards. These are summarised below:
API commit to the achievement of BAT in this application to minimise discharge to
surface water.
There are no direct discharges to salmonid waters from the Allergan facility.
There is no direct discharge to shellfish waters from Allergan. The stream in the
centre of the site discharges to Clew Bay (designated Shellfish Water) approx 2.2
km downstream of the plant. All discharges to this stream are fitted with
abatement (interceptors etc.) and monitored on a regular basis.
No direct discharge to bathing waters. The nearest designated Bathing Water is
Betra Beach, Murrisk approx 9km west of the site. The potential for a discharge
from the Allergan facility impacting on this bay is minimal.
No discharges to groundwater. Only Schedule 2 pollutant employed is Mercury,
which is used in trace quantities in an enclosed system with no pathway to
groundwater.
There are no direct discharges to drinking water abstraction points from the
Allergan facility.
Clew Bay is not designated as a “nutrient sensitive area” under the relevant
Regulations
The Allergan facility employs only one of the Priority Hazardous Substances listed
in the Regulations (Mercury) but this is only used in trace levels in an enclosed
system and there is no pathway for discharge to surface water.
The facility operates under an Environmental Management System and
undertakes an Environmental Liability Risk Assessment on a 3-year basis to
identify and mitigate potential risks to the environment from site operations.
Nearest designated Natura 2000 site is the Clew Bay Complex SAC (site code
001482), approximately 2.2km west of the facility. The appropriate assessment
for the Biologics II facility shows no cumulative impact in this site.
NPWS mapping indicates five Annex 1 Birds Directive Species in the Clew Bay
area Gavia immer, Branta leucopsis, Limosa lapponica, Sterna hirundo, Sterna
paradisaea and Sterna albifrons. Given the distance to the site there is no threat
to protected birds from the Allergan facility.
No discharges to freshwaters or any known pearl mussel habitat streams.
No discharge of asbestos from the Allergan facility
- measures to comply with Council Directive 80/68/EEC and 2006/118/EC in
relation to the protection of groundwater.
Groundwater quality monitoring is carried out a biannual basis in accordance with
Schedule C.6 of IPPC Licence P0126-02 and the results are presented in Table I.4(i) of
the main application form.
A review of this data against the standards/thresholds in the groundwater directives,
demonstrates that all levels detected in the groundwater around the site are within the
standards and thresholds set by the implementing Regulations with the exception of
ammonium. Elevated levels of ammonium are detected in GW3 and GW4 and are
considered to be naturally occurring from the peat in these areas. This report is included in
Attachment I.4.
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With the exception of these naturally occurring ammonium levels in GW3 and GW4, the
ambient groundwater in the area is in compliance with the Regulations and the operation of
the plant is not considered to pose a risk of any adverse effect to groundwater.
- measures to be taken for minimizing pollution over long distances or outside the
territory of Ireland.
All discharges to air, surface water, sewer and noise emissions will be maintained within
BAT levels or the levels agreed with Mayo County Council (emissions to sewer) at the
boundary of the facility. There are no emissions to ground. As such, no pollution will
occur offsite either in the immediate vicinity of the Westport area, over long distances or
outside the territory of Ireland.
All waste streams (with the exception of process water) are taken off-site for disposal
recovery. The majority of hazardous waste is shipped to Germany and Netherlands for
incineration. Other non-hazardous wastes are taken offsite to locations in Ireland for
recovery. The various waste streams and ultimate destinations are presented annually in
the AER for the facility. In all cases the waste is collected by a suitably permitted
contractor and sent to a suitably permitted/licensed facility for disposal/recovery. All
wastes exported are dispatched under control of the TFS Regulations.
- the main alternatives to the proposed technology, techniques and measures
studied by the applicant.
Chapter 4 of the EIS attached to this application identifies the key alternatives
considered by Allergan for the development of the Biologics II facility. The alternative
locations, site layouts and approaches to the design of the facility are addressed in full.
In relation to the proposed technology, techniques and measures for the facility, Allergan
have sought to incorporate BAT, where possible, to achieve the maximum level of
environmental protection for all environmental media.
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