1. The Swiss Biosafety Clearing-House (CH-BCH) http://www.ch-bch.ch Swiss Agency for the Environment, Forests and Landscape (SAEFL) Albert Spielmann

2. 2 The Swiss Biosafety Clearing-House (CH-BCH)  Overview of the CH-BCH  Biotechnology and biosafety in Switzerland  The Swiss policy and the CH-BCH development history  Description of the CH-BCH application

3. 3 Swiss regulatory framework in the area of biotechnology and biosafety  Role of competent authorities  Responsabilities and competences

4. 4 Animal Vaccines Food Biocides Seeds Feed Fertilisers Pesticides Experimental Releases Gene Therapies Medicaments Vaccines Federal Office of Agriculture Federal Office of Agriculture Federal Office of Public Health + Swissmedic Federal Office of Public Health + Swissmedic Federal Veterinary Office Federal Veterinary Office Swiss Agency for the Environment, Forests and Landscape Swiss Agency for the Environment, Forests and Landscape Competent authorities => Based on the intended use of the LMO

5. 5 SAEFL Coordination of enforcement SAEFL is the competent authority: field release experiments SAEFL Applicant Swiss Expert Committee for Biosafety (SECB) Swiss Ethics Committee on Non-human Gene Technology (ECNH) Cantonal competent authority Human HealthAnimal Health SFOA SFOPH FVO Agriculture Environment Application Decision Statement

6. 6 Federal Law on Non-human Gene Technology Containment Ordinance Ordinance on Transboundary Movements of GMO Federal Law on the Protection of the Environment Release Ordinance Ordinance on Accident Prevention Experts Committee Ordinance Ethics Committee Ordinance Federal Law on Epidemics

7. 7 Swiss policy concerning the CH-BCH  Swiss political organization (Fed. State)  Decentralized functions and responsibilities between Cantons, Federal Agencies and Offices  Specific needs for Switzerland  User and group management  Workflow / Access right  Multilingual support  Flexibility  Interoperability => Object-relational database management system

8. 8 Swiss policy concerning the CH-BCH  4 options  Register data in the central portal using the Management centre  Register data locally using database templates and send data to the central portal  Make data available through a local website and allows the central portal to crawl to retrieve metadata  Store data on national databases, and actively make those data available through the central portal using BCH interoperability protocols

9. 9 Swiss policy concerning the CH-BCH  Choice of option 4: Interoperability  Major reasons:  Swiss political organization (Federal State):  Need of a decentralized user and group management system  Data are physically stored in Switzerland  Security of the records  Mandatory Swiss specific information can be included in new elements independent from the central BCH portal  Swiss biosafety information  Public awareness

10. 10 The CH-BCH development history  Swiss environmental data catalogue: envirocat  150 groups involved  Environment relevant data, projects, documents, Internet links and resources  www.envirocat.ch www.envirocat.ch  Swiss Clearing-House Mechanism (CH-CHM)  Information platform related to biodiversity (CBD)  www.ch-chm.ch www.ch-chm.ch => Developed using IRMI: Information and Resource Management Interface

11. 11 System architecture  IRMI:  Based and developed using open source products only  Basic software for the application  Linux operating system  PostgreSQL Database program  ZOPE Content Management System (Python)  Installation and hosting of the system  Redhat and SUSE Linux Distributions  Hosting at one central server (Apache)  Open source components (free or very low cost)

12. 12 System architecture: Client/server system PostgreSQL database ZOPE middleware Internet browser Client Database adapter Layout level SQL Module Internet Database -> Data Bowser -> Communication Middleware -> Application Client / Server Mozilla, Firefox, Netscape, Opera, Internet-Explorer

13. 13 Description of the Swiss Biosafety Clearing- House application  Description of the CH-BCH system  General concept  Utilization of elements  Live demonstration  Conclusion / discussion

14. 14 Description of the CH-BCH application  General concept  Multi-user system  Decentralized user and group management  Data input controlled by:  Elements with specific attributes  Relationship between different element types  Interaction of different roles and status  Multilingual system  Supports as many languages as required without changing the database  Interoperability  Use of common formats and exchange protocols  Simple data management by multiple users having different roles  Multilingual system  Fully interoperable with the central BCH website

15. 15 General concept: Object-relational database Decision Law LMO Competent Authority Organization Related LMO Competent authority Contact Name Legal basis Person Organisation

16. 16 Elements types ElementsDescription Person General information about a person Organization Any organizations such as agencies, departments, institutes, etc. Law Laws, regulations, guidelines Hyperlink Hyperlink to other web sites Information General information LMO (Living Modified Organisms) Description of the LMO Decision on LMO Decision by the competent authorites Competent National Authority Organization or Person National Focal Point Organization or Person

17. 17

18. 18 Role and User Authorization RoleDescriptionAuthorizationWriting access Anonymous Unknown user, anybodyView published elementsNo Member Member of a group, ID with username and password Like anonymous, Can read specific published elements of a group No Author Member of an entity entering data in the database Like member Can create, modify or submit new elements Yes Editor Member of an entity controlling data quality Like author Publish or reject elements Yes Administrator Person responsible for the central administration Like editor Management of users, groups and folders Yes Super Administrator Responsible for administrative operations during installation of the system Create top levels groupsNo

19. 19 Status and Workflow StatusDescriptionProcess (Role) -> New status Open Content of element open for changes, work in progress Submit (Author) -> Submitted Publish (Editor) -> Published Delete (Author) -> Deleted Submitted Element editing completed. Waiting for the release by the Editor Publish (Editor) -> Published Reject (Editor) -> Rejected Retract (Author) -> Open Rejected Rejected by the Editor (quality control) Like open Published The element is published and cannot be modified Expire (Authot, Editor) -> Expired Delete (Author) -> Deleted Retract (Author, Editor) -> Open Expired Old version not valid anymoreRetract (Author, Editor) -> Open

20. 20 Access control by role and element status Role of users Anonymous Member Author Editor Administrator Role of users Anonymous Member Author Editor Administrator Element status Open Submitted Rejected Published Expired Element status Open Submitted Rejected Published Expired Quality control Worflow

21. 21 Decentralized management of the data Federal Office of Public Health Food Federal Veterinary Office Animal vaccines Swissmedic Gene therapies, medicaments, vaccines Federal Office of Agriculture Feed, seeds, fertilizers, pesticides Swiss Agency for the Environment, Forests and Landsacape Field releases BCH Focal point Author Administrator Central Database SCBD Central BCH portal

22. 22 Language  Multilingual system  As many languages as required  No change in the database  One master language (CH-BCH: English)  Translations through internal functions which query an internal translation database  Translation database = Datasets in database tables

23. 23  Multilingual support  Master language is English  CH-BCH: 4 languages supported Language support: workflow DeleteView/statusEdit View/statusEdit X Create ActionStatus Master- language

24. 24 Utilization of elements: Anonymous functionality -> Live

25. 25 Free text search Search by element types Search by owners

26. 26 List of results, can be sorted by title, type,language or owner Quick overview

27. 27 Available translations Help texts Direct links to additional element types Direct links to Internet resources

28. 28 Conclusions  Multi users system Information between many different partners  Quality control  Information quality controlled by role and element status  Multilingual system  As many languages as required  Flexible system  Possibility of creating new elements for specific information  Interoperability  Elements similar to the central BCH (common format)  Fully interoperable database with the central BCH  Open source components  System based on open source components only  Fully operational and interoperable since Jan 04

29. Capacity building: The CH-BCH as standard «exchange of information tool» for interested countries Swiss Agency for the Environment, Forests and Landscape (SAEFL) Albert Spielmann

30. 30 Supported transfer of the system  Entire system is available  Application adapted to the specific needs of the interested partner  System hosted in Switzerland  Technical and training support is provided  Help available (hotline, e-mail)  Management of data by receiving country

31. 31 Supported transfer  Conditions/requirements  Technical:  Reliable and stable Internet connection  Political:  Written agreement  Know-How:  No special IT knowledge needed  Short training course for users (1 day in Switzerland)

32. 32 Supported transfer  Advantages  No needs for high-tech hardware or IT knowledges  Only stable Internet connection required  Short training of users sufficient  Disadvantages  Data are physically stored in Switzerland  This condition could be viewed as a starting solution  At anytime, databases can be transferred back to the country of origin