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RISK ASSESSMENT & APPROVAL: EU member states decide for mandatory 90-day feeding trials for GM food approval



                                  PART 1


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TITLE:   MEMBER STATES BACK 90-DAY GM FEED TRIALS

SOURCE:  Europolitics, Belgium

AUTHOR:  Ed Bray

URL:     http://www.europolitics.info/sectorial-policies/member-states-back-90-day-gm-feed-trials-art348700-11.html

DATE:    27.02.2013

SUMMARY: "All toxicity trials to check the safety of genetically modified food and animal feed for EU sale must last for at least 90 days, member states agreed, on 25 February. The move follows calls from several national food safety authorities, such as ANSES in France and NGOs, for longer testing rules in the wake of a controversial French study linking tumours in rats with GM maize NK603. The two-year study by French Professor Gilles-Eric Séralini, published on September 18 last year, was widely criticised by food safety bodies for its ?inadequate? design and methodology. The paper was of ?insufficient scientific quality to be considered valid for risk assessment,? the European Food Safety Authority said. But ANSES responded by demanding more rigorous rules for EU feed trials."

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MEMBER STATES BACK 90-DAY GM FEED TRIALS

All toxicity trials to check the safety of genetically modified (GM) food and animal feed for EU sale must last for at least 90 days, member states agreed, on 25 February. The move follows calls from several national food safety authorities, such as ANSES in France and NGOs, for longer testing rules in the wake of a controversial French study linking tumours in rats with GM maize NK603. The two-year study by French Professor Gilles-Eric Séralini, published on September 18 last year, was widely criticised by food safety bodies for its ?inadequate? design and methodology. The paper was of ?insufficient scientific quality to be considered valid for risk assessment,? the European Food Safety Authority said. But ANSES responded by demanding more rigorous rules for EU feed trials.

Marco Contiero from Greenpeace said the EU needs to ?redesign safety testing so that it routinely assesses impacts over the long term?. Twenty countries at the standing committee of national experts voted in favour of the 90-day minimum.

The UK, the Netherlands, Belgium and Sweden voted against the proposal, while Portugal and Latvia abstained. The change will raise the current minimum level from 17 days, although in practice over 75% of toxicity tests in applications for licences to sell GM food and feed last for at least 90 days. Corinne Lepage (ALDE), a leading French MEP on GMOs, criticised the decision, arguing that the evaluation of GMO risks should last for two years. Meanwhile, the animal welfare NGO Eurogroup for Animals slammed the mandatory use of animal tests.

The decision goes against the Commission?s policy of reducing animal testing where possible, they added. Commission officials said the change would be published in the EU Official Journal?in the coming weeks?.



                                  PART 2

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TITLE:   NEW GMO REGULATION PASSED BY UNACCOUNTABLE COMMITTEE

SOURCE:  GM Watch, UK

AUTHOR:  

URL:     http://gmwatch.org/index.php?option=com_content&view=article&id=14664:new-gmo-regulation-passed-by-unaccountable-committee

DATE:    27.02.2013

SUMMARY: "A new Regulation laying out how risk assessments for GM food and feed will be carried out was voted into law on 25 February in the Commission?s Standing Committee on the Food Chain and Animal Health. We have not seen the final text of the law, which has been developed in a non-transparent and secretive system known as comitology. Our take on the new law, as far as we can tell from our view of an earlier draft and unofficial reports, is that it contains some improvements over the current system but also some serious flaws."

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NEW GMO REGULATION PASSED BY UNACCOUNTABLE COMMITTEE

NOTE: A new Regulation laying out how risk assessments for GM food and feed will be carried out was voted into law on 25 February in the Commission?s Standing Committee on the Food Chain and Animal Health. We have not seen the final text of the law, which has been developed in a non-transparent and secretive system known as comitology.

Our take on the new law, as far as we can tell from our view of an earlier draft and unofficial reports, is that it contains some improvements over the current system but also some serious flaws.

GOOD: It makes animal toxicological testing of single event GM crops mandatory. Until now, toxicological testing was usually done, but it wasn?t mandatory and could be carried out according to any absurdly weak study design that industry chose.

BAD: It only requires a 90-day maximum rat feeding study. As Seralini?s 2012 study showed, 90 days is not long enough to see chronic health effects, like organ damage and cancer, which take a long time to show up.

GOOD: It requires the 90-day study to have sufficient statistical power (over 80%). This means that if there is an effect from the GM food, it will be harder for industry to hide it.

VERY BAD: The risk assessment will continue to be based on the comparative assessment, a concept developed by industry and inserted into the European GMO regulations and EFSA risk assessment guidelines through the efforts of the International Life Sciences Institute. Comparative assessment is a cynical rebranding of the discredited term ?substantial equivalence?, which assumes that a GM food is the same as a non-GM food.

http://www.powerbase.info/index.php/European_Food_Safety_Authority:_A_playing_field_for_the_biotech_industry

POTENTIALLY GOOD: Industry has to provide proof that the GMO is equivalent to the non-GM parent variety apart from the introduced trait. We are told that no currently available GMO and no GMO in the approval pipeline could pass this test. We are withholding judgement on this aspect of the new law while we see how it is implemented, or indeed WHETHER it is implemented.

CATASTROPHICALLY BAD: One article of the new law allows for ?derogations?. This effectively means that industry can submit a dossier lacking certain elements required by the regulation if industry believes those elements are not ?necessary?. Groups working on pesticides tell us that derogations are regularly used to enable a pesticide that is banned to be un-banned - if, for example, a farmer says he needs to use it.

The press release below expresses concern that the new law will not apply to GMOs already in the approvals pipeline.

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GMOs: European governments play the pyromaniac fireman!

Press release, Feb 27 2013

UNAF / Confederation Paysanne / Les Amis de la Terre (Friends of the Earth France) / FNAB / France Nature Environnement / Greenpeace

English translation from the French by GMWatch

The representatives of 27 governments of the European Union together, February 25, 2013 in the Standing Committee on the Food Chain, abruptly decided to open the European market to 66 new GMOs. 27 of them could also invade the fields.

Today, manufacturers who want to market GMOs themselves decide the protocols to assess the food safety of their product. In response to concerns of consumers and citizens noting that more and more products of the new technology landed on their plate and in the field without any serious evaluation, Europe has suspended its authorization procedures pending the definition of official protocols. The regulation adopted on 25 finally makes toxicological testing mandatory. This decision should reassure consumers who have declared that it was not until now!

But our governments have decided that these new rules will not apply to the 93 cases currently pending. GMOs are therefore ?assessed? according to more lax protocols that have allowed the systematic authorization of the overwhelming majority of GMOs so far examined by the committee of European experts.

It seems that the French Government has accepted this deception. The undersigned organizations denounce this outrageous backsliding that goes against the public interest. Following a succession of scandals undermining consumer confidence in the safety of industrial products introduced into our fields and onto our plates, they expect the French government to state immediately why it intends to oppose [the new law?s] implementation.

Signed

UNAF / Confederation Paysanne / Les Amis de la Terre (Friends of the Earth France) / FNAB / France Nature Environnement / Greenpeace