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, Forests and Landscape (SAEFL)

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

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

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

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

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. 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. 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. 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

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. 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

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

16. Elements types

18. Role and User Authorization

19. Status and Workflow

20. 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

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

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. 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 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 Albert Spielmann Swiss Agency for the Environment, Forests and Landscape (SAEFL)

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. 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. 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