Team:Groningen/Safety/Legislation

From 2009.igem.org

Revision as of 13:30, 21 October 2009

Dutch Legislation

The legislation around biotechnology in the Netherlands is largely build around European guidelines and decrees. The main subjects in this legislation are to guarantee:

• Safety of humans, animal and environment
• Protecting the consumer and fair trade

Working with genetically modified organisms (GMO's) in the Netherlands is prohibited without a permit. [http://international.vrom.nl/ The Ministry of housing, Spatial Planning and the Environment] grants these permits, on grounds of the [http://wetten.overheid.nl/BWBR0004703/ decree Genetically modified organisms], as it is the primary authority on this subject. The [http://wetten.overheid.nl/BWBR0004703/ decree Genetically modified organisms] is supplemented by the [http://wetten.overheid.nl/BWBR0009653/ sanction Genetically modified organisms] containing specifications for rules, general safety precautions and facility and workrequirement. However the lab facility should also follow the [http://wetten.overheid.nl/BWBR0005829/ decree for arrangement- and permits environmental management].
[http://international.vrom.nl/ The Ministry of housing, Spatial Planning and the Environment] shares its responsibilities with the Dutch ministries of:

• [http://www.minvws.nl/en/ Health, Welfare and Sport],
• [http://www.minlnv.nl/portal/page?_pageid=116,1640354&_dad=portal&_schema=PORTAL Agriculture, Nature and Food Quality],
• [http://www.ez.nl/english/Organisation/ Economic affairs],
• [http://www.minocw.nl/english/index.html Education, culture and science],
• [http://www.minbuza.nl/en Foreign affars]
• [http://english.justitie.nl/ Justice]

All represented in the Interdepartmental consultation Biotechnology, where actual affairs and progress of biotechnological projects are discussed.

Technical-scientific advice on the issues concerning the risks for humans and environment with applications of GMO's is given by [http://www.cogem.net/page.ocl?pageid=46&loc=5&version=&mode= The Dutch Committee on Genetic Modification (Cogem)] which also gives advice on the safety precautions to take to protect them against those risks. [http://www.cogem.net/page.ocl?pageid=46&loc=5&version=&mode= Cogem] also gives information on the ethical- and society issues on genetic modification. Cogem already reviewed the Synthetic biology in the Netherlands: [http://www.cogem.net/ContentFiles/CGM080925-01-Biological%20machines1.pdf Biological machines? Anticipating developments in synthetic biology], in which they divided the question about the hazards of synthetic biology in three parts:

1. Is there a legislative framework for action?
2. Can technical safety measurements be taken to manage risks?
3. Can the risks be assesed?

The final conclusion of this report stated that for synthetic the current legislation for GMO's (summarized above) is fully applicable to synthetic biology. A need for new safety legislation especially for synthetic is non-exsting, however this report assumes that the work of synthetic organisms remains in laboratory environments.

University of Groningen

Within the [http://www.rug.nl University of Groningen] the organization of biological safety, including all activities that are carried out with genetically modified organisms (GMOs), is the legal responsibility of the Board of the University of Groningen. The University Board thus acts as the notifier in all GMO-related research where notification is required. The Faculty Boards have been mandated by the Board of the University to implement the rules as set out in the GMO Regulations within their own faculty.

Within the University of Groningen, biological safety is ensured on the central level by a biological safety organization comprising the biological safety officers (BSO) as well as a staff member of the Health, Safety and Environment Service (HSE). The HSE coordinates the notifications, maintains the register and, in cooperation with the BSO, advises the Faculty Boards and the University Board in the field of biological safety. The central organization is complemented on the local level by responsible officers.

BSO officers are appointed by the University Board on the recommendation of the Faculty Boards. In order to be considered for this position, BSO officers must have been approved by the [http://international.vrom.nl/ The Ministry of housing, Spatial Planning and the Environment] on the basis of the qualifications as set out in the GMO regulations. BSO officers are members of the staff office and can report directly both to the University board and their own faculty.

For each project a responsible officer will be appointed by the University Board on the recommendation of the Faculty Board. This officer is responsible for various aspects, including day-to-day matters concerning the activities involving genetically modified organisms.

Further reading

• [http://openwetware.org/wiki/Synthetic_Biology:SB2.0/Biosecurity_resolutions Synthetic Biology:SB2.0/Biosecurity resolutions]

Global legislation

• [http://www.biodiv.org/convention/articles.asp?lg=0 Convention on biological diversity]
  • [http://www.biodiv.org/doc/legal/cartagena-protocol-en.pdf Cartega (Biosafety) Protocol]
• [http://unece.org/env/pp/gmo.htm Aarhus Convention]
• [http://www.infomil.nl/aarhus Aarhus Convention]

European legislation

• [http://europa.eu.int/smartapi/cgi/sga_doc?smartapi!celexapi!prod!CELEXnumdoc&lg=NL&numdoc=32003R1830&model=guichett Regulation (EG) nr. 1830/2003]: Traceability and labeling GMO's and traceability GMO produced food and feed.
• [http://europa.eu.int/smartapi/cgi/sga_doc?smartapi!celexapi!prod!CELEXnumdoc&lg=NL&numdoc=32003R1829&model=guichett Regulation (EG) nr. 1829/2003]: Genetically modified food & feed
• [http://europa.eu.int/smartapi/cgi/sga_doc?smartapi!celexapi!prod!CELEXnumdoc&lg=NL&numdoc=32003R1946&model=guichett Regulation (EG) nr. 1946/2003]: Transport of GMO's accross borders.
• [http://www.vrom.nl/Docs/milieu/Richtlijn_2001_18.pdf Directive 2001/18]: Introduction of GMO's in the environment.

Dutch legislation

• [http://www.overheid.nl/biotechnologie/regels Dutch legislations regarding biotechnology]
  • [http://www.kennislink.nl/publicaties/bacterien-en-antibiotica-resistentie Bacteria & antibiotic-resistence]
  • [http://www.vrom.nl/pagina.html?id=2706&sp=2&dn=w401 Dutch Biotechnology Policy (2000)]
  • [http://www.vrom.nl/pagina.html?id=9262 Waste disposal]

Involved organisations

International organisation

[http://bch.cbd.int/ The Biosafety Clearing-House]

National organisation

• [http://www.icgeb.org/~bsafesrv/biobiblio.html Biosafety bibliographic database]
  
• [http://www.en.bvfplatform.nl/home.html The Association BVF Platform]
  
• [http://www.rivm.nl/milieuportaal/onderwerpen/bodem/ggo-en-bodem/ GMO’s in the environment]
  • [http://213.154.234.72/Paginas/bggo.htm Bureau of GMO’s]
    
  • [http://www.cogem.net/page.ocl?pageid=46&loc=5&version=&mode= Committee on Genetic modification]
    
• [http://international.vrom.nl/ The Ministry of housing, Spatial Planning and the Environment]
  • [http://www.vrom.nl/pagina.html?id=8324 biotechnology]
• [http://www.nvmm.nl/nvmm/nvmmcms.nsf/viewdoc/hom-01?opendocument Dutch society for microbiology]
  

Institutional organisation

• [http://www.rug.nl/Bureau/expertisecentra/amd/milieu/milBiologischeVeiligheid?lang=en Biosafety at the University of Groningen]