Transcript English

The Swiss Biosafety Clearing-House
(CH-BCH)
http://www.ch-bch.ch
BUWAL
OFEFP
UFAFP
SAEFL
Albert Spielmann
Swiss Agency for the Environment, Forests and Landscape (SAEFL)
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
2
Swiss regulatory framework in the area of
biotechnology and biosafety
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Role of competent authorities
Responsabilities and competences
3
Competent authorities
Food
Biocides
Gene Therapies
Medicaments
Vaccines
Federal Office
of Public Health
+
Swissmedic
Federal
Veterinary Office
Animal Vaccines
=> Based on the intended use of the LMO
Experimental Releases
Swiss Agency for the
Environment, Forests
and Landscape
Federal Office
of Agriculture
Seeds Feed
Fertilisers Pesticides
4
Coordination of enforcement
SAEFL is the competent authority: field release experiments
Application
SAEFL
Applicant
• Swiss Expert Committee
for Biosafety (SECB)
• Swiss Ethics Committee
on Non-human Gene
Technology (ECNH)
SFOA
SFOPH
Agriculture
Human Health
FVO
Animal Health
• Cantonal competent
authority
Statement
Decision
Statement
SAEFL
Environment
5
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
6
Swiss policy concerning the CH-BCH
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Swiss political organization (Fed. State)
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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
7
Swiss policy concerning the CH-BCH

4 options

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

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
8
Swiss policy concerning the CH-BCH
Choice of option 4: Interoperability
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Major reasons:
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Swiss political organization (Federal State):
Need of a decentralized user and group management
system
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Data are physically stored in Switzerland
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Security of the records
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Mandatory Swiss specific information can be included in
new elements independent from the central BCH portal
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Swiss biosafety information
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Public awareness
9
The CH-BCH development history

Swiss environmental data catalogue: envirocat
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150 groups involved
Environment relevant data, projects, documents, Internet links
and resources
www.envirocat.ch
Swiss Clearing-House Mechanism (CH-CHM)
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Information platform related to biodiversity (CBD)
www.ch-chm.ch
=> Developed using IRMI:
Information and Resource Management Interface
10
System architecture
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IRMI:
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Basic software for the application
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Based and developed using open source products only
Linux operating system
PostgreSQL Database program
ZOPE Content Management System (Python)
Installation and hosting of the system
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

Redhat and SUSE Linux Distributions
Hosting at one central server (Apache)
Open source components (free or very low cost)
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PostgreSQL
database
Server
System architecture: Client/server system
Database -> Data
Database adapter
SQL
SQL
Module
SQL
SQL
Module
SQL
ZOPE
middleware
Middleware -> Application
Module
Layout level
Internet browser
Client
Client
Mozilla, Firefox, Netscape,
Opera, Internet-Explorer
/
Internet
Bowser -> Communication
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Description of the Swiss Biosafety ClearingHouse application

Description of the CH-BCH system
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General concept
Utilization of elements
Live demonstration
Conclusion / discussion
13
Description of the CH-BCH application

General concept
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Multi-user system
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Data input controlled by:
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Elements with specific attributes
Relationship between different element types
Interaction of different roles and status
Multilingual system
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Decentralized user and group management
Supports as many languages as required without changing the database
Interoperability
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Use of common formats and exchange protocols
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Simple data management by multiple users having different roles
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Multilingual system

Fully interoperable with the central BCH website
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General concept: Object-relational database
LMO
Organization
Name
Person
Decision
Related LMO
Competent authority
Law
Legal basis
Competent
Authority
Organisation
Contact
Person
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Elements types
Elements
Description
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
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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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Worflow
Access control by role and element status
Role of users
Element status
• Anonymous
• Member
• Author
• Editor
• Administrator
• Open
• Submitted
• Rejected
• Published
• Expired
Quality control
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Decentralized management of the data
Author
Central Database
Federal Office of Public Health
Food
Author
Federal Veterinary Office
Animal vaccines
Administrator
Author
Swissmedic
Gene therapies, medicaments,
vaccines
Swiss Agency for the Environment,
Forests and Landsacape
Field releases
BCH Focal point
SCBD
Central BCH portal
Author
Federal Office of Agriculture
Feed, seeds, fertilizers, pesticides
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Language
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Multilingual system
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As many languages as required
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No change in the database
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One master language (CH-BCH: English)
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Translations through internal functions which query an
internal translation database
Translation database = Datasets in database tables
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Language support: workflow
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Multilingual support
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Master language is English
CH-BCH: 4 languages supported
Masterlanguage
Status
Action
Create
Create
X
Edit
View/status
Edit
View/status
Delete
23
Utilization of elements: Anonymous functionality
-> Live
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Free text search
Search by element types
Search by owners
25
List of results, can be sorted by
title, type,language or owner
Quick overview
26
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
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Quality control
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Multilingual system
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Elements similar to the central BCH (common format)
Fully interoperable database with the central BCH
Open source components
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Possibility of creating new elements for specific information
Interoperability
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As many languages as required
Flexible system
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Information quality controlled by role and element status
System based on open source components only
Fully operational and interoperable since Jan 04
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Capacity building:
The CH-BCH as standard «exchange of
information tool» for interested countries
BUWAL
OFEFP
UFAFP
SAEFL
Albert Spielmann
Swiss Agency for the Environment, Forests and Landscape (SAEFL)
Supported transfer of the system

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Entire system is available
Application adapted to the specific needs of the
interested partner
System hosted in Switzerland
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Technical and training support is provided
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Help available (hotline, e-mail)
Management of data by receiving country
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Supported transfer
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Conditions/requirements
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Technical:
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Political:
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Reliable and stable Internet connection
Written agreement
Know-How:
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No special IT knowledge needed
Short training course for users (1 day in Switzerland)
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Supported transfer
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Advantages
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No needs for high-tech hardware or IT knowledges
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Only stable Internet connection required
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Short training of users sufficient
Disadvantages
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Data are physically stored in Switzerland
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This condition could be viewed as a starting solution
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At anytime, databases can be transferred back to the country of
origin
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