ＮＭＩ Ｊ 1 July 31, 2007 Y. Miki, T. Ihara, T. Tsugoshi, M. Koike, K. Chiba, and I. Fujima National Metrology Institute of Japan (NMIJ) National Institute of Advanced Industrial Science and Technology （ＡＩＳＴ） New Scheme of Notification on the National Metrology Standards

ＮＭＩ Ｊ 2 １. Brief review of Japanese measurement system Measurement Law and Japanese Calibration Service System (JCSS) Role of NMIJ 2. Needs for reference materials and new schemes Needs in laboratory medicine, food and environmental safety Start of the development of new schemes to meet the needs, for example, NMIJ “Endorsed” Reference Materials Case study in RM development for diagnosis of metabolic syndrome Topics

ＮＭＩ Ｊ 3 - Traditionally, the Measurement Law of Japan provided legal metrology. - In 1992, the Japan Calibration Service System (JCSS) was established. ・ the internationalization of measurement systems ・ technological innovation ・ demands for consumer protection - JCSS plays a vital role in the establishment of Japan’s traceability system, because it has extremely high name recognition and reliability in Japan. ・ accelerate Japan's traceability by using the Measurement Law - JCSS is characterized by its relative rigidity hierarchical structure. Japanese Measurement Law

ＮＭＩ Ｊ 4 Japanese Calibration System Service NMIJ Designated Calibration Labs （ CERI, JEMIC, JQA) Registered Calibration Labs End Users ~150 Labs jcss Certificates JCSS Certificates Measurement Law ~100 RMs 45 Specified physical stds. NMIJ also provides standards directly to users outside the law

ＮＭＩ Ｊ 5 Examples of recent needs for reference materials Waterworks Law(revised 2003) - 50 checkpoints for water quality - 26 checkpoints including some regarding 101 pesticides for water control Regulation of residual pesticides(revised 2006) - shift from a negative-list system to a positive-list system - reference materials to apply uniform limit values (about 800 substances)

ＮＭＩ Ｊ 6 Are the measurement standards that are supplied by NMIJ sufficient? (1)Testing laboratories are performing calibrations using standard products supplied by private reagent manufacturers. (2)In order to secure comparability in measured values, testing laboratories are requesting a reagent manufacturer to produce standard products that are commonly used by them. 101 reference materials for agricultural chemicals (Waterworks Law) Covered by NMIJ Supplied by Chemical Companies Coherency of standard products? Test lab. A Test lab. B Test lab. C

ＮＭＩ Ｊ 7 Long term target 250 items for each of physical and chemical standards Development Plan Number of Standards Development according to the plan FY2005 FY2006 FY2007 Development of Measurement Standards by NMIJ NMIJ Staff 280 Scientists (55 Chemists)

ＮＭＩ Ｊ 8 １. More measurement standards should be specified by reconsideration of the criteria, to meet the expanding needs. 2. NMIJ should take a major role to coordinate activities among the related institutions to establish measurement standards in Japan. Discussion about amendment of the Measurement Law New Schemes Evaluation service instead of providing RMs NMIJ “Endorsed” RMs

ＮＭＩ Ｊ 9 (1)Long time is required for developments of the SI-traceable measurement standards. (2)Private reagent manufacturers has the prompt supply systems in response to urgent needs. NMIJ endorses use of RMs as “Endorsed” Reference Materials if they are reliable enough to be the top of the traceability chain. The reference materials which the Measurement Law covers are mainly gases, inorganic solutions, pH, etc. Manufacturers are supplying over 800 agricultural chemicals NMIJ checks equivalence of RMs with the same quality and the validity of the assigned quantity values. NMIJ “Endorsed” Reference Materials

ＮＭＩ Ｊ 10 Conceptual image of traceability system enhancement traceability system enhancement SI traceable reference materials Standard substances & reagents developed by private companies Ensuring of international consistency(CIPM/MRA) Ensuring of domestic consistency (1) Domestic compatibility should be established first. - The current review targets those standards that are required for securing consistency with domestic measurement values. (2) International compatibility should be established thereafter. - Cooperation between NMIs. Measurement Law

ＮＭＩ Ｊ 11 Metabolic Syndrome(2008) - the Ministry of Health, Labour and Welfare said if man has waistline of 85 centimeters or more, he has a risk of metabolic syndrome. -the medical checkup for Metabolic Syndrome prevention will start in April, reference materials are needed for evaluating ８ items of blood test data of neutral fat, HDL/LDL cholesterol, etc. Case Study of NMIJ “Endorsed” Reference Material 85cm diagnostic criteria My waistline is 95.3cm

ＮＭＩ Ｊ 12 Development of RMs for Diagnosis of Metabolic Syndrome Ministry of Economy, Trade, and Industry (METI) Ministry of Health, Labour and Welfare (MHLW) Working Group Japanese Committee for Clinical Laboratory Standards (JCCLS) Reagent Manufactures Testing Laboratories Medical Doctors Committee for Examination of “Endorsed” RMs NMIJ

ＮＭＩ Ｊ 13 Summary (1) Japanese measurement system are briefly reported. (2) Needs for RMs are getting prominent in the fields of laboratory medicine, environmental and food safety. (3)In the course of reviewing the measurement law, extension of specification of RMs and enhancement of the NMIJ role are discussed. (4) In accordance of the above discussion, NMIJ is developing new schemes, one of which is “Endorsed” RMs, with a case study of developing RMs for diagnosis of metabolic syndrome.

ＮＭＩ Ｊ 14 Thank you !