1. NCSL International 2002 Improving dialogue between the European Regulatory Bodies and the National Metrology Institutes through the RegMet project Fiona Redgrave and Andy Henson International Office National Physical Laboratory 7 August 2002

2. RegMet project  RegMet Project ‘Improving dialogue in Europe between the Regulatory Bodies and the National Metrology Institutes’ A 30 month project: November 2000 to May 2003 Collaborative project (partly) supported by the European Commission* *‘Competitive and Sustainable Growth’ contract G7RT-CT2000-05005

3. Project Partners  Project is led by the National Physical Laboratory (UK)  The partners are: BNM Bureau National de Métrologie (France) CMI Czech Metrology Institute (Czech Republic) DFM Danish Institute of Fundamental Metrology (Denmark) EOTC European Organisation for Conformity Assessment IRMM JRC - Institute for Reference Materials and Measurements JV Justervesenet (Norway) NMi-VSL NMi Van Swinden Laboratory NPL The National Physical Laboratory (UK) PTB Physikalisch-Technische Bundesanstalt (Germany) SMU Slovak Institute of Metrology (Slovak Republic) SP Swedish National Testing Institute (Sweden)

4.  The WTO technical barrier to trade initiative (TBT)  The transatlantic business dialogue (TBD) and the Transatlantic Economic Partnership (TEP)  The trade MRA  The 1999 “Accept” Project:*  Different perspectives across the Atlantic: - Europe critical of US regulatory practice (traceability to NIST)! - US critical of 15 different approaches per sector in Europe! *Mutual Acceptance of calibration Certificates between EUROMET and NIST: SMT4-CT97-8001 Context

5.  Recognition that Europe had work to do - European aspiration that US would begin to tackle TBT’s too  Led directly to the MetroTrade and RegMet projects - MetroTrade: addressing direct measurement issues related to trade between regions - RegMet addressing indirect measurement issues for trade and commerce, focussing on the European regulatory approach to measurement RegMet - Origins of the Project

6.  Need for appropriate measurements  Ensuring a level playing field internationally (in the European Single Market)  Ensuring consistent scientific data internationally  Ensuring that the benefits of the CIPM MRA are capitalised upon Drivers from Trade and Commerce

7.  Mutual recognition of national measurement standards and of calibration and measurement certificates issued by National Metrology Institutes (NMIs) – see www.bipm.org  The CIPM MRA was signed in 1999 by the NMIs in 38 countries and 2 international organisations  As part of the CIPM MRA, NMIs are required to: - Participate in a Key and Supplementary Comparisons - Declare and subject their Calibration and Measurement Capabilities (CMCs) to extensive peer review - Implement appropriate quality systems CIPM Mutual Recognition Arrangement

8. The specific objectives are to:  promote a greater awareness of metrological issues amongst regulators - networking arrangements - provide access to the project results  promote a ‘common’ best practice approach to metrology by regulators  identify more precisely regulators’ measurement needs on an on-going basis RegMet - Project Objectives

9.  Dialogue with over 100 regulators across Europe  Identification of examples of measurement best practice in a regulatory environment  International workshop on ‘Metrology for Regulation and Trade’  Initial development of concept of ‘template for measurement’ RegMet – Progress to date

10.  Diverse range of metrological awareness and understanding within and between sectors  Fragmented approach even within sectors and some regulatory bodies  Some sectors still nationally orientated  Many issues common across sectors  Some regulators are already addressing measurement as an important issue, increasingly in an international context RegMet – Illustrative results (1)

11. Problems encountered by regulators and enforcers include:  Requirements difficult to test in practice  Standards allowing use of a range of methods which have not been cross ‑ validated and provide different results  Lack of suitable certified reference materials  Insufficient reliable data for rigorous risk assessments  Dynamic and real ‑ time measurements  Specified limits close to the physical limits of detection  Need to operate in a rapidly changing global environment RegMet – Illustrative results (2)

12.  Covers many areas: - Nuclear - Fire - Transport - Electrical - Hazardous substances in the workplace - Construction………etc no single approach to measurement policy  An inevitable variation in the approach to measurement - explosives is different to occupational exposure RegMet - Health and safety regulation

13.  Lower allowable limits for both emitted and ambient pollutants  increased prominence of measurement issues  Advent of IPPC Directive  need for a level playing field and meaningful data to Brussels for policy decisions (e.g. global warming)  Emissions trading  direct monetary link  Need to monitor “on-line” (e.g. stack emissions) *Council Directive 96/61/EC Concerning Integrated Pollution Prevention and Control RegMet - Environmental regulation

14. Development of the Monitoring Certification Scheme (MCerts) by the UK Environment Agency  Product certification  Use of laboratories accredited by national accreditation body  Competency certification of personnel  Operates under international and European standards (ISO/IEC 17025, EN45011 and EN45013)  Collaboration with UBA to align the German and UK schemes as far as possible to enable mutual certification Measurement best practice (environment)

15.  Regulation and enforcement of food safety is of increasing concern within Europe and beyond  Many bodies responsible for food safety have/are undergoing re-structuring and change  Need for suitable certified reference materials RegMet – Food regulation

16. Clean sheet approach to measurement by the UK Food Standards Agency (new organisation)  Entered into an agreement with UKAS  Uses ISO/IEC 17025  Provides additional specific guidance when the international standard is not sufficiently detailed  Realisation that equal consideration should be given to measurement aspects when undertaking research and surveys that will input to and underpin legislation Measurement best practice (food)

17.  A somewhat fragmented approach (historical and technical)  The need for appropriate measurement -lower limits, more complexity:- measurement issues become more apparent  The need for robust measurement -regulators more likely to be challenged in court  The need to operate in a global environment  But some regulators are already developing sound approaches to measurement issues to address these changes RegMet - Summary of Regulators issues

18. Workshop on ‘Metrology for regulation and trade’ held jointly with the MetroTrade project in May 2002  Provided a forum to foster dialogue between the metrology community and regulatory and trade stakeholders  Attended by delegates from 13 countries including South America and South Africa  Endorsed the ‘template’ approach RegMet – workshop

19. Template - Rationale for the template  Increasing importance of measurement in regulation  Importance implies an upstream of legislation through to enforcement approach  Regulation increasingly operates in a global environment  Whilst there are differences and variations between regulatory fields, there is much that is common

20. RegMet – Template for Regulators A systematic and transparent approach to measurement to aid regulators and others when considering measurement issues  A core set of principles and guidelines for addressing cradle to grave measurement issues from the highest level across a wide range of regulatory fields  Optimising use of the international metrology infrastructure  Allows specific sectoral needs to be incorporated

21. Template – Cradle to grave Ensuring an appropriate approach to measurement when:  Undertaking research or utilising existing data which will potentially influence regulations and EC directives etc  Formulating regulations, EC directives and supporting standards etc  Undertaking market surveillance Achieved in a manner that is consistent and avoids technical barriers to trade.

22. Template - Preparation of regulations To ensure an appropriate approach to measurement when formulating regulations and European directives  Identification of the need (if any) for supporting research  Ensuring an appropriate approach to measurement when undertaking the supporting research  Consideration of: - technical limits and uncertainties - validated measurement techniques - ability to make traceable measurements - Balance protection of the public against cost/practicality appropriate limits

23. Template - Implementation of regulations To ensure appropriate measurements  Market surveillance measurements should: - be measurable, robust and defensible - balance cost / practicality / improved accuracy - be of suitable uncertainty to adequately assess compliance - utilise national, European and world measurement infrastructures appropriate measurements

24.  National Metrology Institutes  Regional Metrology Organisations  CIPM Metre Convention  CIPM Mutual Recognition Arrangement  Accredited laboratories and test houses  Accreditation bodies  European Accreditation co-operation  ILAC  Notified bodies  OIML  International Standards such as ISO 17025  Plus many others Benefiting from existing infrastructure

25. Achieving some of these aims would require:  Appropriate methods, procedures and standards  Provision of specific requirements in addition to supplement existing standards  Validated methods?  Use of measurements traceable to the SI (where feasible)  Estimate of uncertainty of measurement  Initiating appropriate research in a timely manner when no appropriate measurement standards, methods and data exist  Robust technical limits avoiding unnecessary TBTs Template - Issues to be addressed?

26. Template - Reducing trade barriers Although RegMet is focussed within the EU single market, it is important to remember the interregional trade context:  RegMet activity presented at NCSL  NIST kept informed  European Commission proposing transatlantic consideration of the RegMet template using the “Regulatory Cooperation” tool from the TEP  We also must not forget the developing world …..template approach is transparent and systematic

27. The template (voluntary) would aim to achieve more effective regulation through:  Identification and adoption of measurement best practice, including utilisation of existing infrastructures  Improved confidence in results obtained within regulatory fields  Increased harmonisation, consistency and avoidance of duplication of effort  Provide a common platform for interregional trade negotiations and avoiding TBTs Template - Benefits

28. The outcome – better and more effective regulation…..?  Basis of a (common) template for addressing measurement for (voluntary) adoption by regulators  Promoting, as far as practical, a harmonised approach by the regulators to metrological issues taking into account differing sectoral needs within Europe  Enhanced ability for regulators to input to the National Measurement Systems research prioritisation  An ongoing network for advice RegMet – the outcome?

29. RegMet project Information on the RegMet project may be found at www.regmet.dk THANK YOU fiona.redgrave@npl.co.uk