BU WALO F E F PU F A F P S A E F L

The Swiss Biosafety Clearing-House(CH-BCH)

http://www.ch-bch.ch

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

Albert Spielmann

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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

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Swiss regulatory framework in the area ofbiotechnology and biosafety

Role of competent authorities Responsabilities and competences

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Animal Vaccines

FoodBiocides

Seeds FeedFertilisers Pesticides

Experimental Releases

Gene TherapiesMedicaments Vaccines

Federal Office of AgricultureFederal Office of Agriculture

Federal Office of Public Health

+Swissmedic

Federal Office of Public Health

+Swissmedic

Federal Veterinary Office

Federal Veterinary Office

Swiss Agency for theEnvironment, Forests

and Landscape

Swiss Agency for theEnvironment, Forests

and Landscape

Competent authorities

=> Based on the intended use of the LMO

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SAEFL

Coordination of enforcementSAEFL is the competent authority: field release experiments

SAEFL

Ap

plic

ant

• Swiss Expert Committee for Biosafety (SECB)

• Swiss Ethics Committee on Non-human Gene Technology (ECNH)

• Cantonal competent authority

Human Health Animal Health

SFOA SFOPH FVO

Agriculture

Environment

Application

Decision

StatementStatement

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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

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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

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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

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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

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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

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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)

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System architecture: Client/server system

 

PostgreSQLdatabase

ZOPEmiddleware

Internet browserClient

Database adapter

Layout level

SQL SQL SQL SQL SQL

Module Module Module

Internet

Database -> Data

Bowser -> Communication

Middleware -> Application

Clie

nt

/

S

erve

rMozilla, Firefox, Netscape,Opera, Internet-Explorer

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Description of the Swiss Biosafety Clearing-House application

Description of the CH-BCH system General concept Utilization of elements Live demonstration Conclusion / discussion

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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

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General concept: Object-relational database

Decision

Law

LMO

CompetentAuthority

Organization

Related LMO

Competent authority

Contact

Name

Legal basis

Person

Person

Organisation

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Elements types

Elements DescriptionPerson 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

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Role and User Authorization

Role Description Authorization Writing

access

Anonymous Unknown user, anybody View published elements No

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 groups No

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Status and Workflow

Status Description Process (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 anymore Retract (Author, Editor) -> Open

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Access control by role and element status

Role of users

•Anonymous•Member•Author•Editor•Administrato

r

Role of users

•Anonymous•Member•Author•Editor•Administrato

r

Element status

•Open•Submitted•Rejected•Published•Expired

Element status

•Open•Submitted•Rejected•Published•Expired

Quality controlQuality control

Worflow

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Decentralized management of the data

Federal Office of Public HealthFood Federal Veterinary Office

Animal vaccines

SwissmedicGene therapies, medicaments,

vaccines

Federal Office of AgricultureFeed, seeds, fertilizers, pesticides

Swiss Agency for the Environment,Forests and Landsacape

Field releasesBCH Focal point

Author

Author Author

Author

Administrator

Central Database

SCBDCentral BCH portal

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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

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Multilingual support Master language is English CH-BCH: 4 languages supported

Language support: workflow

DeleteView/status Edit 

  View/statusEditX

    Create  

    Create  

ActionStatusMaster-

language 

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Utilization of elements: Anonymous functionality

 

-> Live

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 Free text search

Search by element types

Search by owners

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List of results, can be sorted bytitle, type,language or owner

Quick overview

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Available translations

Help texts

Direct links to additional element types

Direct links to Internet resources

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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

BU WALO F E F PU F A F P S A E F L

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

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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

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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)

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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