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[genet-news] SCIENCE & RISK ASSESSMENT: EU looks to tighten GM crop assessment rules



                                  PART 1


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TITLE:   EU LOOKS TO TIGHTEN GM CROP ASSESSMENT RULES

SOURCE:  Thomson Reuters, USA

AUTHOR:  Charlie Dunmore

URL:     http://uk.reuters.com/article/idUKTRE6AB22Y20101112

DATE:    12.11.2010

SUMMARY: "The EU's food safety watchdog issued new guidelines on Friday for assessing the environmental impacts of genetically modified plants, as part of a shake-up of the bloc's GM crop approval system. The guidelines from the European Food Safety Authority set out new assessment procedures for biotech companies when submitting GM crops for EU approval, including on possible long-term effects of GM crops and their impacts on insects and other plants."

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EU LOOKS TO TIGHTEN GM CROP ASSESSMENT RULES

BRUSSELS (Reuters) - The EU's food safety watchdog issued new guidelines on Friday for assessing the environmental impacts of genetically modified (GM) plants, as part of a shake-up of the bloc's GM crop approval system.

The guidelines from the European Food Safety Authority (EFSA) set out new assessment procedures for biotech companies when submitting GM crops for EU approval, including on possible long-term effects of GM crops and their impacts on insects and other plants.

The new guidelines follow a request from EU governments in 2008 to strengthen EFSA's GM crop assessment procedures, and criticism from countries including France that EFSA had failed to take full account of environmental concerns when approving new crops.

France has refused to discuss European Commission proposals to let member states decide whether to grow or ban GM crops, until the EU's assessment procedures have been strengthened.

A spokesman for the European Commission said the EU's executive would discuss the new guidelines with member states next month, before updating the bloc's environmental risk assessment rules for GM crops.

In December, the Commission is due to publish a report on the socio-economic risks and benefits of GM crops, and new rules on monitoring GM crops are due next year, as part of the wider overhaul of the bloc's approval and assessment procedures.

(Reporting by Charlie Dunmore, editing by Rex Merrifield and Keiron Henderson)



                                  PART 2

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TITLE:   EFSA UPDATES GUIDANCE ON ENVIRONMENTAL IMPACT OF GM PLANTS

SOURCE:  European Food Safety Authority, Italy (EFSA)

AUTHOR:  Press Release

URL:     http://www.efsa.europa.eu/en/press/news/gmo101112.htm

DATE:    12.11.2010

SUMMARY: "The European Food Safety Authority has published updated guidance for the environmental risk assessment of Genetically Modified plants, reflecting the scientific state-of-the-art in this field. [...] This guidance implements the stringent requirements for the environmental risk assessment of GMOs as provided by Directive 2001/18/EC on the deliberate release of GMOs in the environment."

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EFSA UPDATES GUIDANCE ON ENVIRONMENTAL IMPACT OF GM PLANTS

The European Food Safety Authority (EFSA) has published updated guidance for the environmental risk assessment (ERA) of Genetically Modified (GM) plants, reflecting the scientific state-of-the-art in this field.

Scientific experts on EFSA?s GMO Panel have updated and further developed its guidance for the environmental assessment of GM applications submitted for authorisation in the EU, in particular with respect to data generation, collection and analysis. The ERA guidance document also addresses the evaluation of possible long-term effects of GM plants and potential effects on non-target organisms (NTOs)[1]. This guidance implements the stringent requirements for the environmental risk assessment of GMOs as provided by Directive 2001/18/EC on the deliberate release of GMOs in the environment.

The European Commission requested EFSA in 2008[2] to further develop and update its guidance on environmental risk assessment,enabling EFSA to build on the work it had initiated in this area in 2007.

In accordance with the conclusions of the Environment Council of December 2008, Member States and stakeholders were closely associated with the review of this guidance. EFSA organised a series of technical discussions on the guidance document with representatives of EU Member States[3], with non-governmental organisations (NGOs) and with GM applicants[4] to exchange views on the scientific issues. A draft version of the ERA guidance was also launched earlier this year for public consultation[5] which received 494 comments.

In order to assess the safety of a GM plant submitted for authorisation in the European Union, EFSA requires all applicants to follow its guidance documents which specify the type of data and information that should be submitted. In the ERA guidance, EFSA reviewed and updated seven specific areas that need to be addressed when assessing the environmental impact of a GM plant. These include in particular the persistence and invasiveness of the GM plant, taking into account possible plant-to-plant gene transfer; the likelihood and consequences of gene transfer from the plant to micro-organisms; the potential evolution of resistance in target organisms; the potential effects on non-target organisms; the biogeochemical processes, such as changes in soil composition, and the potential impact of the cultivation, management and harvesting techniques of the GM plant.

The guidance document includes detailed requirements for: the choice of appropriate non-GM comparators[6] and types of receiving environments to be considered; long-term effects and the experimental design of laboratory and field studies; and their statistical analysis.

* Guidance on the environmental risk assessment of genetically modified plants 

[1] A section of the document is specifically dedicated to the assessment of the effects that GM plants may have on non-target organisms (NTOs), that is, those insects which are not meant to be the target of the toxin produced by some GM plants.

[2] Mandate

[3] EFSA meets Member State experts on environmental risk assessment of GM plants  

[4] EFSA?s technical meetings with stakeholders  

[5] Outcome of the public consultation on the draft Scientific Opinion of the Scientific Panel on Genetically Modified Organisms (GMO) on the guidance document on the environmental risk assessment of genetically modified plants

[6] GM comparators are the non-GM plants with which the GM plant is compared during the safety evaluation.




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