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Department/Office:
Department of the Environment,
Community and Local Government
Title of legislation:
European Communities technical specifications for chemical analysis and monitoring of water status (groundwater and
Stage: surface waters) Regulations
Date:
30 June 2011 Final
Related publications:
The European Communities (Water Policy) Regulations, 2003 (SI 722 of 2003)
The European Communities Environmental Objectives (Surface waters) Regulations, 2009 (SI 272 of
2009)
The European Communities Environmental Objectives (Groundwater) Regulations, 2010 (SI 9 of 2010)
Available to download at: ( www.environ.ie
)
Contact for enquiries: James O’Connell
Assumpta Manning
Telephone: 053-911 7441
053-9117546
What are the policy objectives being pursued ?
To establish technical specifications for chemical analysis and monitoring of water status in accordance with Article 8(3) of the Water Framework Directive (2000/60/EC) and as elaborated in the WFD daughter Directive 2009/90/EC. The objective of
Directive 2009/90/EC is to establish common quality rules for chemical analysis and monitoring of water, sediment and biota carried out by all EU Member States. The
Directive must be transposed into national legislation by 20 August 2011.
What policy options have been considered?
1.
No change in policy
This is primarily being included as a baseline for comparisons. To take no action would mean a failure to comply with our EU obligations and could result in prosecution by the European Commission.
2.
Introduce the proposed new technical specifications for chemical analysis and monitoring of water status (groundwater and surface waters) through mandatory regulations
This option to regulate involves transposing the requirements of Directive
(2009/90/EC) on technical specifications for chemical analysis and monitoring of water status. The proposed regulations specify the rules that laboratories must comply with when monitoring and analysing groundwater and surface waters for the purpose of classifying water status under the Water Framework Directive (2000/60/EC).
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3.
Rely on voluntary adoption of the new technical specifications for chemical analysis and monitoring of water status (groundwater and surface waters).
This is not a realistic option, as Directive 2009/90/EC requires all EU
Member States to bring laws, regulations and administrative provisions necessary to comply with the Directive into force by 20 August 2011.
However, it serves as a benchmark for comparison.
Preferred Option:
Introduce the proposed new technical specifications for chemical analysis and monitoring of water status (groundwater and surface waters) through mandatory regulations. This is the preferred option because it will ensure that water status monitoring data are subjected to rigorous quality controls and procedures and are consequently reliable and directly comparable across the state and across the EU.
The reliability of water status monitoring data is critical to proper implementation of the Water Framework Directive (2000/60/EC). Water status chemical monitoring data
(water, sediments or biota) are used by the Environmental Protection Agency (EPA) to classify the status of groundwater and surface water bodies. Status of water bodies is used as the basis for establishing statutory environmental objectives for water bodies. Because management measures must be taken to protect and in some cases restore water bodies to achieve good status it is critical that the monitoring data used for establishing water status in the first place is reliable.
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Options
Costs
1 No change. But would not be cost effective since the reliability of monitoring data could not be guaranteed despite significant current public expenditure on laboratory analyses.
Benefits
No change.
Likely at best to maintain the status quo with no additional administrative burden and associated costs on laboratories.
There would be no benefit in this option as uncertainties would undermine the reliability of environmental water monitoring data for decision making in river basin planning.
2 Some additional direct costs may arise in relation to enhancing technical facilities to meet minimum analytical criteria and deploying the necessary resources to achieve formal laboratory accreditation in accordance with EN ISO/IEC-17025.
Consultations with public authority laboratories indicate that, typically one full time equivalent technician per laboratory is required to comply with the standard.
However, many of the environmental laboratories involved are either already accredited or are in the process of applying for accreditation.
It might be expected that the introduction of the regulations is likely to contribute to driving further
Would result in consistent, quality assured and reliable water status monitoring data meeting international performance standards for the purpose of classifying water status and supporting public authority decision making in water management. Accredited monitoring data would also be comparable with other Member States.
The introduction of new technical specifications for chemical analysis and monitoring of water status through mandatory regul ations would create a “level playing field” for both public and private laboratories in terms of the performance standards they are required to apply to the analysis of water, sediments and biota used for the purpose of establishing water status.
The proposed date in 2015 coincides with the deadline for
Drinking Water data. This would allow for substantial synergic benefits in terms of “planning ahead” since many laboratories analyse for parameters which are common to both Drinking water and WFD
Impacts
No change. Would maintain status quo .
With regard to impacts on sectors the impact will be minimal. However, it could be argued that uncertainty in relation to the reliability of monitoring data may indirectly cause inconsistencies in the assessment of discharge licence applications from businesses.
This option also means that Ireland will be non-compliant with Directive 2009/90/EC and infringement action will be taken by the EU Commission.
This option would ensure consistency and confidence in the results of water status monitoring. Hence, it is likely to increase confidence among public authorities when making decisions on management measures to protect and improve water status. If monitoring datasets are subjected to scrutiny they would be more robust, defensible, quality assured, transparent and traceable.
The impact on sectors will be minimal. It could be argued that this option would result in more consistent and reliable water monitoring data and would, therefore, indirectly contribute to creating a “level playing field” in the assessment of discharge licence applications from businesses.
This option also means that Ireland will be fully compliant with Directive 2009/90/EC.
This option would involve a greater administrative burden
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Options
Costs rationalisation of local authority laboratories.
3 There would be no cost savings compared to Option 2 (Regulations).
If adoption with the technical specifications for monitoring and analysis was voluntary there is a risk that some public bodies responsible for monitoring would not comply with the specifications in order to avoid the additional administrative burden and avoid additional costs. This would be a “false economy” as the monitoring data from unaccredited laboratories may not be considered as reliable as those from accredited laboratories.
There would be a risk of data being rejected as being unreliable or not comparable giving rise to substantial
“correction costs”.
Benefits Impacts on laboratories undertaking water status analysis.
However, the laboratories involved are either already accredited or have indicated plans already in place to apply for accreditation. Local authorities are required by the EPA to have drinking water analyses carried out by accredited laboratories by 2015.
Consequently, the additional burden caused by the proposed regulations is unlikely to be significantly greater than that already committed to.
There would be flexibility for laboratories to comply with technical specifications for monitoring and analysis.
However, this flexibility would be undesirable. There would be a significant risk that not all laboratories would adopt the technical specifications for chemical analysis and monitoring of water status. This would potentially lead to inconsistencies and lack of comparability of monitoring data across the state and would undermine confidence in the national water monitoring programme. There would also potentially be an “uneven playing field” and a lack of common performance standards in monitoring water status between public body laboratories (or their service providers).
Voluntary adoption of the new technical specifications for chemical analysis and monitoring of water status runs the risk of generating monitoring data of inconsistent quality across the state. This would result in mixed confidence in the reliability of the monitoring data for the purpose of supporting decision making in river basin planning. Data may also be incomparable with other EU Member States.
This option also means that Ireland will run the risk of being non-compliant with Directive 2009/90/EC and infringement action will be taken by the EU Commission.
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STATEMENT OF POLICY PROBLEMS AND OBJECTIVES
Directive 2009/90/EC, commonly known as the QA/QC Directive (Quality Assurance /
Quality Control), is a direct response to Article 8(3) of the Water Framework Directive
(2000/60/EC). Article 8(3) states that for the purposes of monitoring surface water status, groundwater status and protected areas “Technical specifications and standardised methods for analysis and monitoring of water status shall be laid down in accordance with the procedure laid down in Article 21”. Article 21 refers to the Regulatory Committee established for the WFD.
The European Water Framework Directive (WFD, 2000/60/EC) aims to improve, to protect water quality (groundwater, surface inland waters and coastal waters) and to prevent further deterioration across Europe within specified time periods. The implementation of the WFD depends on the availability of reliable and comparable chemical analytical results across the EU. The WFD requires the monitoring of water quality to be performed by methods that conform to the CEN/ISO standards or with other national or international standards which will ensure the provision of data of an equivalent scientific quality and comparability. The Article 21 Regulatory Committee agreed on the technical specifications for chemical analysis and monitoring of water status in January
2009. The procedure was subsequently adopted by the European Parliament and
Council in July 2009. All Member States, including Ireland, are required to transpose the
QA/QC Directive into national legislation by August 20, 2011.
The Directive is a short legal instrument that elaborates technical rules for monitoring that were mandated in the WFD.
The objective of the Directive is to establish minimum performance criteria for methods of analysis to be applied by Member States when monitoring water status (groundwater and surface waters), sediment and biota, as well as rules for demonstrating the quality of analytical results. In particular, the Directive requires that;
1.
All methods of analysis used for the purposes of WFD monitoring programmes must be validated and documented in accordance with the EN ISO/IEC-17025
2.
standard or equivalent international standard.
For each parameter being monitored the level of quantification (LOQ) must be
30% or less of the Environmental Quality Standard (EQS) with a maximum uncertainty of ± 50%. The purpose of this rule is to ensure that monitoring can
3.
4.
reliably confirm compliance or non-compliance with the EQSs established for pollutants or other indicator parameters.
Concentrations of pollutants or indicator parameters below the LOQ found in samples are dealt with in a consistent manner by all laboratories across the
EU. These rules are provided.
Laboratories providing analytical results for WFD monitoring purposes must apply quality management system practices in accordance with the EN
ISO/IEC-17025 standard or equivalent international standard. Laboratories must demonstrate their competency by:

Participating in a proficiency testing programme which complies with
ISO/IEC guide 43-1, and, where appropriate;

Reliably analysing suitable reference materials.
The Directive will ensure that environmental water monitoring analyses and subsequent data from across the EU are reliable, quality assured and comparable.
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The Environmental Protection Agency (EPA) has overall responsibility for the WFD monitoring programme as set out in the 2003 Water Policy Regulations (SI 722 of 2003).
The EPA is also responsible for classifying surface water and groundwater status (SI 272 of 2009 and SI 9 of 2010). Therefore, it is appropriate that the transposing legislation assigns responsibility for overall implementation of the requirements of the QA/QC
Directive. However, as several bodies and agencies (EPA, local authorities and, Marine
Institute), are assigned responsibilities under the 2003 Water Policy Regulations (SI 722 of 2003) for monitoring various parameters for WFD purposes their monitoring and analytical procedures will be bound by the rules in the transposing legislation.
The Directive essentially requires that laboratories conform with the quality management system practices of ISO 17025 although it falls short of requiring that laboratories are accredited to this standard. At present it is expected that all EPA laboratories will be accredited by the end of 2011. The Marine Institute laboratories are also accredited. Only three local authority laboratories Cavan County Council, Cork County Council & Dublin
City Council are currently accredited. However, consultations with local authority laboratories confirmed plans to apply for accreditation by 2012 for the purposes of the
2007 drinking water Regulations 1 . In cases where contracted laboratories carrying out operational monitoring on behalf of the local authorities the majority are accredited.
In terms of analytical challenges the EPA and Marine Institute face the most significant technical challenges as they are required to monitor for Priority Substances and Priority
Hazardous Substances (PS/PHS). Many of these substances have extremely low
Environment Quality Standards (EQS) which are currently technically difficult to measure to an acceptable level of accuracy.
While the Directive does not require that laboratories be accredited to ISO 17025 it is difficult to see how the supervisory obligations of the EPA could be met without the independent verification which accreditation provides. Establishing an alternative verification process (for example an audit by EPA) would create an additional excessive and disproportionate administrative burden on the EPA. In addition, formal accreditation provides an element of security in dealing with potential challenges to licenses which have been awarded on the basis of assessment of water status datasets generated by the national water environmental monitoring programme.
CONSULTATION
Because the impact of the proposed regulations is limited to certain public body laboratories (or their agents) consultations were only held with those bodies directly affected. A consultation meeting was held with representatives from EPA laboratories services, Marine Institute laboratory services and local authority laboratory services in
EPA offices Kilkenny on 8 April 2011. Several follow up written responses were received by 6 May 2011.
ENFORCEMENT AND COMPLIANCE
The Option 2 proposal to introduce the proposed new technical specifications for chemical analysis and monitoring of water status through mandatory regulations will ensure that
1
The European Communities (Drinking water) (No. 2) Regulations 2007 (SI 278 of 2007)
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minimum standards mandated in Directive 2009/90/EC are adhered to. Public bodies assigned a duty of monitoring by the EPA under legislation 2 will be required to comply with the regulations. EPA which has overall responsibility for the national water monitoring programme will be tasked with implementing the requirements including supervising the monitoring and analyses carried out by other public bodies.
Only monitoring datasets compliant with the requirements of the proposed regulations may be used by the EPA for the purposes of classifying water status.
REVIEW
The Regulations require monitoring and analyses carried out for the purposes of classifying water status to be validated and documented in accordance with the international standard EN / ISO/IEC-17025. Furthermore, laboratories must apply quality management system practices in accordance with EN / ISO/IEC-17025 and proficiency testing programmes must meet the requirements of ISO/IEC guide 43-1 or other equivalent standards accepted at international level. Such international standards may be reviewed and revised from time to time in order to incorporate best practices. Therefore, water monitoring and analytical procedures used for the purpose of classifying water status may automatically be revised from time to time to comply with the most up to date international procedural standards.
SUMMARY OF PERFORMANCE OF OPTIONS/RECOMMENDED OPTION
As explained above Ireland is already committed to implementing the environmental water monitoring requirements of the Water Framework Directive (2000/60/EC) and it’s daughter Directive on technical specifications for chemical analysis and monitoring of groundwater and surface water status (2009/90/EC). Therefore, Option 2 (Introduce the proposed new technical specifications for chemical analysis and monitoring of water status through mandatory regulations) is the only realistic option. However, Option 1 (No policy change) and Option 3 (Rely on voluntary adoption of the new technical specifications for chemical analysis and monitoring of water status) serve as benchmarks for comparisons.
The comparisons illustrate that the proposed regulations will ensure that water status monitoring data are subjected to rigorous quality controls and procedures and are consequently reliable and directly comparable across the state and across the EU.
Following consultations there was consensus among the public bodies responsible for water status monitoring that where accreditation has not yet been secured that adequate time be given for laboratories to go through the accreditation process. A similar approach to that taken for the analysis of drinking water was recommended.
Under the EPA drinking water handbook 3 local authority laboratories (or their contracted laboratories) analysing drinking water in accordance with the drinking water Regulations 4 the EPA recommends that laboratories carrying out analysis for determining compliance with the drinking water quality standards should aim to be accredited by the end of 2012 and requires that all analysis must be carried out in accredited laboratories by the end of
2 the European Communities (Water Policy) Regulations, 2003 (SI 722 of 2003)
3
Handbook on implementation for water services authorities for public water supplies. EPA (2010)
4
The European Communities (Drinking water) (No. 2) Regulations 2007 (SI 278 of 2007)
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2015. The EPA will not accept monitoring results from unaccredited laboratories after the end of 2015. Meanwhile laboratories that have not attained accreditation to ISO 17025 are required to use the guidance in the handbook until such time as accreditation is achieved. Such laboratories are to be subject to checking by the EPA or a person approved by the EPA to permit the EPA to ascertain whether the laboratory has a suitable system of analytical quality control in place and meets the specified performance requirements.
In the case of the proposed regulations setting out the technical specifications for the chemical analysis and monitoring of groundwater and surface water status accreditation by 2015 is proposed to be mandatory. As an intermediate measure laboratories which are not accredited prior to the deadline of 2015 will be required to demonstrate compliance with the regulations to the EPA including performance in a suitable
Proficiency Testing scheme. Both public authority laboratories and contract laboratories
(as represented through the Environmental Services Association) have clearly expressed a wish for technical guidance to be issued by the EPA on foot of the regulations being made. This could provide clear guidance on how the regulations are to be applied in practice.
Laboratories will be required to satisfy the requirements of the public EPA Register of laboratories which is based on performance in the EPA scheme and is updated annually.
This Proficiency Testing scheme operates in accordance with ISO/IEC guide 43-1 as required by the QA/QC Directive.
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