The Swiss Biosafety Clearing-House (CH-BCH)

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

2. The Swiss Biosafety Clearing-House(CH-BCH) • Organisation of the session • Part 1: 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 • Part 2: Exercises on the CH-BCH demo application

3. Swiss policy concerning the CH-BCH • Swiss regulatory framework in the area of biotechnology and biosafety

4. 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

5. 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

6. 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

7. 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 • Swiss Clearing-House Mechanism (CH-CHM) • Information platform related to biodiversity (CBD) • www.ch-chm.ch => Developed using IRMI: Information and Resource Management Interface

8. 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)

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

10. Description of the Swiss Biosafety Clearing-House application • Description of the CH-BCH system • General concept • Utilization of elements • Elements attributes • Live demonstration • Conclusion / discussion

11. 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

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

13. Elements types

14. Element attributes • Element PERSON T: Text field K: Key table field R: Relational field H: Hierarchical field I: Inverse relational field Bold: Mandatory field

16. Role and User Authorization

17. Status and Workflow

18. Workflow: Element from creation to publication

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

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

21. 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

22. Language: Database translation table

23. Master-language Status Action Create Create X Edit View/status Edit View/status Delete Language support: workflow • Multilingual support • Master language is English • CH-BCH: 4 languages supported

24. Utilization of elements: Anonymous functionality -> Live

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

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

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

28. Conclusions • Multi users system Information between many different partners • Quality control • Information quality controlled by user’s roles 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. SWISS BIOSAFETY CLEARING HOUSE Based on an application for decentralized data management Test it! http://test.ch-bch.ch/demo http://www.ch-bch.ch

30. The CH-BCH as standard «exchange of information tool» for interested countries http://www.ch-bch.ch Albert Spielmann Swiss Agency for the Environment, Forests and Landscape (SAEFL)

31. Supported transfer • Entire system is available • System installed (hosted) in Switzerland • Technical and training support is provided • Help available by email • Management of data by receiving country

32. Supported transfer • Conditions/requirements • Technical: • Reliable and stable Internet connection • Know-How: • No special IT knowledge needed • Short training course for users

33. 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

34. Supported transfer • Conditions: phase I • Official request in written from interested country • Verification of the request (CB conformity) • Approval of financing (<3 years, Swiss gvt) • Written agreement between the countries • Definition of the needs of the applicant country (form) • Implementation: versions alpha, beta, .. • Training of the administrator • Final version

35. Supported transfer • Conditions: phase II • Hosting of the application (UNEP-GRID) • Technical support of the application • Help, hotline, e-mail services