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Aarhus Convention Application of the Convention to Decisions Concerning Genetically Modified Organisms


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Aarhus Convention
Application of the Convention to Decisions Concerning Genetically Modified Organisms
UK experience of public participation in decisions making on the deliberate release of genetically modified organisms


Summary





  1. In 1992, the UK voluntarily, and we believe uniquely, introduced a public register and public consultation exercises on decisions regarding the deliberate release of genetically modified organisms (GMOs) into the environment. More recently, the UK has completed transposition of the EC Directive 2001/18 governing the deliberate release of GMOs and is therefore now operating the Directive’s new mandatory public participation requirements. As a result, the UK has over ten years’ experience of public participation in decision making.




  1. The UK’s experience is that public consultation/participation is as much a mechanism of public information and transparency as one of ensuring safety. The UK believes it is essential to the credibility of the decision-making process about the deliberate release of GMOs that the process is transparent and all relevant and appropriate information is available to the public both during and after the assessment process. The public should have access to detailed information both about how decisions are taken and the content and consideration of individual applications. The UK recognises that, as with any new technology, there is a degree of uncertainty which causes public concern. Through its public register and more significantly through the Internet, the UK promotes transparency in these procedures.




  1. With regard to assessing whether a particular GMO should be released, individual decisions are made on the basis of an assessment of the substantiated scientific evidence of risk to human health and the environment. Experience to date shows that public consultation does not particularly highlight relevant new evidence concerning any particular GMO. The high degree of UK and EU expert scrutiny already in place ensures that potential risks are identified and taken into account in decision making.



Context


  1. Public participation in decisions on the deliberate release of Genetically Modified Organisms (GMOs) into the environment in the UK are governed by EC Directive 2001/18. The transposing regulations have come into force in England, Scotland, Wales and Northern Ireland. There are two procedures for consenting to the deliberate release of GMOs into the environment. The first, for purposes other than placing on the market, known as “Part B Applications”; the second for placing on the market, known as “Part C applications”.



Deliberate releases for purposes other than placing on the market - Part B Applications


  1. Authorising the deliberate release of GMOs for purposes other than placing on the market is subject to devolution in the UK, with decisions being taken on a territorial basis by the relevant authorities in England, Scotland, Wales and Northern Ireland. The UK’s procedures were recently updated in line with the EC Directive 2001/18, although this gave Member States a large amount of discretion in how they implemented Article 9, which deals with consultation and information on Part B applications and releases. The arrangements followed by the four authorities in processing Part B applications are very similar, including their implementation of Article 9 of Directive.




  1. In accordance with the requirements of Article 9 of the Directive the UK Competent Authority invites representations relating to any risks of damage being caused to the environment by the proposed release. The invitation to make representations to the Secretary of State, including a full copy of the application (excluding commercial in confidence information) is made on the public register and is repeated on the Defra website at www.defra.gov.uk. The period of each consultation has been set at a mandatory minimum of 48 days (the 48 day period comes from the fact that details of Part B applications must be placed on the public register within 12 days of receipt and that the period of consultation must not end less than 60 days from the date the application was received).




  1. Applicants are also required to advertise their application in a national newspaper within 10 days of sending it to the Secretary of State. The advertisement must contain information on the GMO, and the location, dates and purpose of the intended release. It should also mention that details of the application will be placed on the public register and that the Secretary of State will invite representations on safety issues raised by the proposed release. The applicant is also required to inform a number of organisations of the application, including the local authority, the parish (community) council, the Environment Agency and English Nature.




  1. Upon receipt of representations, the case officer dealing with the application will go through all response identifying the scientific issues raised. If relevant evidence were raised that had not already been considered by the Advisory Committee on Releases to the Environment (ACRE – the statutory scientific expert committee that advises the four territorial authorities), it would be brought to the Committee’s attention to be taken into account alongside other relevant evidence. Among other things, ACRE’s advice to the authorities on all Part B applications contains a response to the public representations. ACRE’s advice is available on the public register and published on the ACRE website (www.defra.gov.uk/environment/acre/index.htm), as are the minutes of every Committee meeting. Details of every site with an active consent are also provided. All respondents are notified of the outcome of applications.




  1. Since transposing Directive 2001/18 in October 2002, the English territorial authority has processed applications to conduct research trials on GM wheat, peas, potatoes and for GM vaccines containing S.typhi and E.coli. The GM wheat application received the largest amount of responses (74). The second largest was on GM potatoes application (7). However, this public participation has generated no relevant new information related to the evidence of environmental or health risk assessment for each application. Some respondents did not restrict their comments to scientific points but also wrote in to express more general concerns, for example social-economic, “ethical” and other non-safety based concerns.




  1. Comments in the main were received from individuals, some of which were on behalf of organisations such as Friends of the Earth and Genewatch, and occasionally there have been small campaigns where a number of people have used the same template letter.




  1. The positive opinion of ACRE and consequent issuing of the consent very rarely caused members of the public to write back and object to the consent being granted.




  1. Applications for GMMs for clinical trials generate hardly any interest at all.



Part C Applications - Deliberate Release for Placing on the Market


  1. Public comments on Part C marketing applications are made directly to the Commission, in line with Article 24 of the EC Directive 2001/18. Members of the public are able to comment on each and every application submitted to the EU. These consist of two 30 day periods within which individuals can comment on the dossiers; as soon as the Summary Notification Information Format (SNIF) is received by the Commission and again if and when a favourable opinion is issued by the lead member state. Both of these documents are placed on the Commission’s dedicated website (www.gmoinfo.jrc.it) with the deadline for comments highlighted. This website includes a facility to automatically notify anyone registered with the site that a new document has been published and thus a new consultation period opened. Comments can be made online as well as in writing.




  1. The majority of the comments received on the 22 applications currently being processed have been from the UK. The number of respondents on each application vary. For the three applications on which opinions have been forwarded 37 of the 81 comments made were from the UK, although this is a little simplistic since some people have written one letter covering all applications and one letter had over twenty names and addresses following the letter. However, where comments are received on dossiers for which the UK are the lead Member State the comments will be taken into consideration where relevant. As the two applications for which the UK is the lead member state are still under initial assessment, this procedure has not yet begun.




  1. A database of all the part C marketing applications is kept on the Defra website. The site also contains a table of the current applications and the current stage of assessment. There is also a link to the Commission website. The UK opinion on applications where other Member States have submitted a positive assessment are also available.



Conclusion

  1. The UK has set in place a number of procedures for promoting the transparency of the decision making processes concerning GMOs and to facilitate the public’s involvement in such decisions. The UK’s experience from procedures pre-dating the new EC Directive was reflected in the Guidelines adopted at the first Meeting of the Parties, to which the UK was pleased to contribute. However, the new mandatory procedures introduced by the EC Directive are still less than a year old. As they become more widely understood, more people may take advantage of the opportunities. New procedures for further encouraging involvement are still being developed. Accordingly, it is too early for the UK to reach any conclusions on whether any changes are necessary or would be effective.


Department for Environment, Food and Rural Affairs

United Kingdom

July 2003


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