FEMA, TOEAST - Japan's stockpile of Electronic Tools

Transcription

1 Electronic Tools used for Existing and New Chemicals Government/Industry Activities Japanese perspective OECD Workshop on Electronic tools Ottawa, Canada October 2-4,2002 1

2 Introduction Kotaro YOSHIDA NITE (National Institute of Technology and Evaluation) Chemical Management Center 2

3 NITE National Institute of Technology and Evaluation Independent Administrative Institution Established 01/04/2001 Main 4 fields Biotechnology Chemical Management Conformity Assessment Welfare Technology Chemical Management Center Chemical Substances Control Law PRTR Chemical Weapon Total Management of Chemical Substances 3

4 Outline Scope Chemicals Substances Control Law Data flow Assembly and Submission Review and Evaluation Archiving of data and reviews Other Information 4

5 Scope Chemical Substances Control Law of Japan (CSCL) 3 Authorities (METI, MHLW &MoE) New Chemicals Existing Chemicals Specified Chemicals (Class I and II ) Designated Chemicals 5

6 Data Flow New Chemicals Assembly producers and importers Submission producers and importers Review METI, MHLW and MoE Evaluation 3 Councils and a 3 Ministries Archiving Each of the Ministry (case by case) 6

7 Data Flow Existing Chemicals Priority Setting ( selection) Testing Plan Examination Review Evaluation Archiving publication 7

8 Assembly and Submission Data Notification Form (New Chemicals only) Summaries Chemical Substance card Electronic data available Study Reports 8

9 Assembly and Submission Electronic Tools Tool For submitters and testing laboratories (New Chemicals) JENSONC from 01/04/2002 (Japanese Electronic Notification System Of New Chemicals) Tool For OECD/HPV work IUCLID Tool For managing data of Examination of Existing Chemicals JENSOC (Japanese Electronic Notification System of Chemicals) 9

10 Assembly and Submission JENSONC Data Assembly Data Storing Make Submission data (CD-R) Re-use XML (Summaries) TIFF (Study Reports) 10

11 Assembly and Submission JENSONC OS Microsoft Windows Browser IE6.0 Scanner TWAIN Visual Basic and mdb Microsoft Data Access Components HTML/XML exchange TIFF (Group4) and JPEG Viewer IE6.0 Chemical structure (TIFF ChemDraw) 11

12 Review and Evaluation Japan Review Reports are made by using word processing software Microsoft Word (Fareast Version), ICHITARO, etc. Review and Evaluation has been done by assessors Decision is sent in hard copy to each notifier by each Ministry. (New Chemicals) Review reports not made public due to CBI. (New Chemicals) 12

13 Archiving of Data and Reviews New Chemicals To be stored as paper files and electronically in the JENSONC Archiving System. Adhere to strict security procedures for protecting confidential business information. Existing Chemicals Archived at each Ministry by each way. METI (Biodegradation and Bioaccumulation data ) Optical Disks (study reports), Oracle database (summaries) MHLW (Human toxicity data), JENSOC databases, Oracle database 13

14 Work Program METI has provided data to the public on its evaluations of biodegradability and bioaccumulation potential on existing chemicals. (approximately 1200 existing chemicals) available on the NITE S web-site MHLW has conducted toxicity data collection for acute, repeat dose and Reproductive toxicity along with mutagenicity etc.. available on the NIHS s web-site as one of GINC (approximately 250 existing chemicals) information ( 14

15 Other information METI s voluntary programme the Comprehensive Chemical Substances Assessment and Management Program to develop a method for comprehensive assessment and management of chemical substances risks and Qsar systems to provide risk assessment reports of some existing chemicals outcomes will be available on the NITE s web-site. 15

16 JENSOC and IUCLID Export file formats are not compatible. Similarities between JENSOC and IUCLID: Support XML Glossaries Language 16

17 Merit of using electronic tools Paperless Costless Reuse Replacement Management Data storing/archiving Qsar 17

18 Domestic matter Language Japanese OS Software FEP XML (description of TAG and notes) Submission form Assessment Report 18

19 Future Global data exchange Public use of data Archiving tool and databases searchable similarity of chemical structure sharing data 19

20 contacts Kotaro YOSHIDA Naoyuki YASUDA 20