July 10, 2010 Issue of AgBioView
http://www.agbioworld.org/

EU Effort to End GM Crop Deadlock Meets Resistance

– Christian Spillman, AFP, July 13, 2010

BRUSSELS – The European Commission sought Tuesday to end a deadlock blocking the growth of genetically modified crops in Europe, proposing to give countries the freedom to ban the controversial foods. But the proposal drew immediate protests on both sides of the issue amid deep divisions in Europe over the safety of such food.

“The Commission is not in favour or against GMOs,” said European Health Commissioner John Dalli. “But in today’s world, they are a reality and Europe cannot stand idle and deny itself the political responsibility to take decisions and implement a policy of responsible innovation.”

Europe has fallen behind the rest of the world amid public concerns over the potential effects of GM crops demonised as “frankenfoods” by opponents. With governments unable to reach a consensus on the authorisation of new crops, the commission decided to give individual states the power to prohibit or plant such seeds.

Under the proposed rules, once a new GM crop is authorised, governments would be able to ban them across all or part of their territory for socioeconomic, ethical or moral reasons, Dalli said.

But French Environment Minister Jean-Louis Borloo said the proposal was “not acceptable” because it did not address the need to improve the authorisation process. “They have proposed a swap, that is not going to work,” Borloo told AFP.

Dalli denied that the proposed rules were aimed at pressuring some governments to end their opposition to new GM crop applications. “I don’t expect countries to change their voting just because we’ve put these considerations,” he said.

Biotech firms are awaiting clearance for the cultivation of four types of genetically modified maize. A maize seed developed by US biotech giant Monsanto, MON 810, is the only crop to have been cleared for commercial cultivation in Europe since 1998.

Six EU states, Austria, Hungary, France, Greece, Germany and Luxembourg, have prohibited MON 810 from their territory but it is grown in Spain, Portugal, the Czech Republic, Romania, Poland and Slovakia.

However, Monsanto’s MON 810 was grown on fewer than 95,000 hectares (235,000 acres) of land in the EU last year, down from almost 107,000 hectares in 2008. A genetically modified potato developed by German group BASF, the Amflora, was given the green light in March but it will only be used for industrial uses for its starch content.

The biotech industry and environmentalist groups slammed the proposal, which has to be adopted by the EU parliament and the European Council. EuropaBio, which represents the industry in Brussels, said the proposed rules “give carte blanche to ban safe and approved GM crops in any country or region regardless of the needs or wishes of their farmers.”

The Green bloc in the European parliament described the proposal as a “dubious bargain” and warning that GM crops posed a contamination threat to other plants. Green EU lawmaker Martin Haeusling said: “The Commission has not been able to overcome the opposition of the member states to GMOs over the years and wants now to trick them into accepting quicker authorisations.”

Opponents of GM food fear they would inevitably contaminate other crops and maintain that is no definitive evidence of their safety. Supporters argue that such crops have higher yields, resist pests and disease better and require less fertiliser and pesticide. They say farmers should be given the freedom to choose whether they want to plant GM crops.

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GMOs: Member States to be Given Full Responsibility on Cultivation In Their Territories

– European Commission, Belgium. July 13, 2010. http://europa.eu

Today the Commission proposed to confer to Member States the freedom to allow, restrict or ban the cultivation of Genetically Modified Organisms (GMOs) on part or all of their territory. While keeping unchanged the EU’s science-based GM authorisation system, the adopted package consists of a Communication, a new Recommendation on co-existence of GM crops with conventional and/or organic crops and a draft Regulation proposing a change to the GMO legislation.

The new Recommendation on co-existence allows more flexibility to Member States taking into account their local, regional and national conditions when adopting co-existence measures. The proposed regulation amends Directive 2001/18/EC to allow Member States to restrict or prohibit the cultivation of GMOs in their territory.

Health and Consumer Policy Commissioner, John Dalli said: “Last March, the Commission promised to present a comprehensive proposal on our future policy vis- a-vis GM cultivation by the end of the summer. Today we deliver on that promise. The concrete measures adopted today will allow Member States the freedom to decide on GMO cultivation. Experience with GMOs so far shows that Member States need more flexibility to organise the co-existence of GM and other types of crops such as conventional and organic crops.”

The Commissioner added: “Granting genuine freedom on grounds other than those based on a scientific assessment of health and environmental risks also necessitates a change to the current legislation. I stress that, the EU-wide authorisation system, based on solid science, remains fully in place. To conclude: This means that a very thorough safety assessment and a reinforced monitoring system are priorities in GMO cultivation and are therefore being pursued vigorously. The Commission is committed to follow up actions on them before the end of the year.”

As of today, a more flexible approach towards cultivation:

The strict authorisation system already in place, which is based on science, safety and consumer choice, will remain the same.

With the new freedom given to Member States to decide on cultivation, a strong signal is sent to citizens that Europe takes into account their concerns, which may vary from one country to another, regarding GMOs. The new approach aims to achieve the right balance between maintaining an EU authorisation system and the freedom for Member States to decide on GMO cultivation in their territory. The proposal delivers on President Barroso s political guidelines, presented in September 2009. Adding this freedom to the legislative framework for GMOs should enable the authorisation system for GMOs to function effectively. As a first step under existing legislation, today s new Recommendation on guidelines for the development of national co-existence measures replaces the previous recommendation of 2003.

The previous Recommendation made a direct link between the establishment of co-existence measures and the respect of the 0.9% threshold for labelling as GM food, feed or products intended for direct processing. Member States were advised to limit co-existence measures (e.g. length of distances between GM and non-GM fields) to comply with 0.9% GM presence in other crops.

Experience gained over the last years shows that the potential loss of income for non-GM producers, such as organic and sometimes conventional producers, is not limited to exceeding the labelling threshold. In certain cases, the presence of GMOs in certain food products may cause damages to operators who would wish to market them as not containing GMOs.

The non-binding guidelines included in the new Recommendation on co-existence better reflect the possibility provided in the existing legislation (Article 26a of Directive 2001/18/EC) for Member States to adopt measures to avoid the unintended presence of GMOs in conventional and organic crops. This also allows for measures aiming to limit GMO content in conventional food and feed to levels below the labelling threshold of 0.9%. The Recommendation also clarifies that Member States can establish GMO-free area and this new Recommendation provides better guidance to Member States to develop co-existence approaches. The European Co-existence Bureau will continue to develop together with Member States best practices for co-existence as well as technical guidelines on related issues.

Legal certainty for the future:

The proposal for revising Directive 2001/18/EC aims to secure legal certainty for Member States when they decide on GMO cultivation on grounds other than those based on a scientific assessment of health and environmental risks. To this end, the Commission proposes to include a new article (26b), which would be applicable to all GMOs that will be authorised for cultivation in the EU, either under Directive 2001/18/EC or under regulation (EC) N1829/2003. Member States will be able to restrict or prohibit GMO cultivation in part or all of their territory without recourse to the safeguard clause. Their decisions will not need to be authorised by the Commission, but Member States will have to inform other Member States and the Commission one month before the adoption of their measures. The Member States will also have to respect the general principles of the Treaties and the Single Market, and be consistent with the international obligations of the EU.

At the same time, the EU authorisation system, based on scientific assessment of health and environmental risks will be maintained and further improved, thus ensuring the protection of consumers and the functioning of the internal market for GM and non-GM seeds, as well as for GM food and feed.

The legislative proposal will be adopted through co-decision with the European Parliament and the Council.

For more information please see:

http://ec.europa.eu/food/food/biotechnology/index_en.htm
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Questions and Answers on the EU’s New Approach to the Cultivation of GMOs

– European Commission, Belgium, MEMO/10/325 http://europa.eu/
Why is the Commission adopting this package today and what does it include?
In March 2010, the European Commission announced that it would come back before the summer break with a proposal on how to combine the EU science-based authorisation system with freedom for Member States to decide on the cultivation of Genetically Modified Organisms (GMOs). The package adopted today delivers on this commitment and complies fully with the position set out by President Barroso in the political guidelines he presented in September 2009.

What are co-existence measures and what does the new Recommendation on co-existence change?

The objective of co-existence measures, in areas where GMOs are cultivated, is to avoid the unintended presence of GMOs in other products, preventing the potential economic loss and the impact of traces of GM crops in non-GM crops, such as conventional and organic crops.

Experience gained over the last years shows that Member States need more flexibility to take into consideration their particular local, regional and national conditions when defining measures to organise the cultivation of GM, conventional and organic crops.

The new Recommendation on co-existence recognises that Member States may adopt measures to avoid the unintended presence of GMOs in other products below the labelling threshold of 0.9%. When co-existence measures are not sufficient to prevent the unintended presence of GMOs in conventional or organic crops, Member States may restrict GMO cultivation in large areas of their territory. Such restriction measures need to be proportionate to the objective pursued (i.e. protection of particular needs of conventional or organic farming).

The Commission published in 2009 the second report on national strategies for coexistence of GM crops with conventional and organic farming. The report shows that 15 Member States adopted legislation on coexistence while three more notified draft legislation.

The European Coexistence Bureau (ECoB) develops together with Member States best practices for co-existence, which take into consideration that Member States need flexibility to take account of their local and regional conditions.

For more information on ECoB: http://ecob.jrc.ec.europa.eu/

What is the current procedure for authorising the cultivation of GMOs?
GMOs are authorised at EU level on a case-by-case basis on the basis of the particular uses defined by the application of the company, after a positive assessment of health and environmental risks. Applications for cultivation of GMOs can be submitted under Regulation (EC) No 1829/2003 for GM food and feed if those GMOs are to be used as source material in food and feed production. GMOs can also be authorised under the Directive for the deliberate release of GMOs into the environment (Directive 2001/18/EC) for uses other than food/feed. In both cases, the Member States play a significant role, carrying out the initial risk assessment of the GMO for cultivation.

What are the amendments to the current legislation proposed by the Commission?
The proposed amendment provides for the addition of one article to Directive 2001/18/EC, which explicitly allows Member States to restrict or prohibit cultivation of GMOs on their territories. Member States may use any grounds to do so, other than those covered by the health and environmental risk assessment of the EU authorisation process. Therefore, the proposal gives competence to Member States to decide on cultivation.

When the legal amendment enters into force, Member States will be free to restrict or prohibit the cultivation of all or particular GMOs, in parts of or in their entire territory. This amendment will be applicable to all GMOs that have been authorised for cultivation in the EU, being under Directive 2001/18/EC or under Regulation (EC) No 1829/2003. According to this proposal Member States are only allowed to adopt measures against the cultivation of GMOs. They are not allowed to adopt measures prohibiting the import and/or the marketing in the EU of authorised GM seeds.

Are any GMOs already cultivated in the EU?
Yes. There is one GM maize MON 810 that is commercially cultivated in the EU. This product s genetic modification aims to protect the crop against a harmful pest – the European corn borer. It was authorised in 1998. A GM starch potato, known as ‘Amflora’ potato, was authorised for cultivation and industrial processing on 2 March 2010. This starch potato has increased amylopectin starch content. The starch is intended for industrial uses, such as production of paper.

What are the GM plants that are authorised in the EU for feed and/or food uses?
Besides cultivation, the placing on the EU market of GMOs and the use of their derived products in the food and feed chain is subject to an EU authorisation. As of today, the list of authorised GMOs includes also: one sugar beet, three soybean, three oilseed-rape, six cotton and 17 maize products.

One of the most recently authorised GMO is the ‘Amflora’ starch potato. As it is the case for conventional starch potatoes, ‘Amflora’ is not intended to be used as food. The by-product of the starch potato (pulp) is authorised as feed. The adventitious or technically unavoidable presence of this potato in food and animal feed is authorised up to a level of 0.9%

The list of authorised GM plants and the precise scope of their authorisation is available in the EU register of GM food and feed, which can be found here: http://ec.europa.eu/food/dyna/gm_register/index_en.cfm

Have Member States already prohibited GMO cultivation?
Six Member States (Austria, Hungary, France, Greece, Germany and Luxembourg) adopted safeguard measures and prohibited the cultivation of the GM maize MON810 on their territories. Moreover, Austria, Luxembourg and Hungary have notified to the Commission the prohibition of the cultivation of the Amflora potato. Poland has legislation in place forbidding the marketing of all GM seeds.

Member States could now reconsider their safeguard measures on GMO cultivation, when there is no scientific justification, and rather use the more flexible Recommendation on co-existence adopted today to avoid unintended GMO presence in other crops.

Once the addition proposed today of the relevant article to Directive 2001/18/EC is applicable, Member States will be able to restrict or prohibit GMO cultivation without resorting to the safeguard clause when no new scientific risk is identified.

Are there any other GMOs for cultivation on which the EU could take decision before the legal change is applicable?
There are more than ten requests for authorisation of GMOs for cultivation (or for their renewal), at different stages of the procedure.

Four GMOs are at an advanced stage. They have received a favourable European Food Safety Authority (EFSA) opinion and their authorisation procedure (or renewal of authorisation procedure) is ongoing. The favourable EFSA opinion concerning the renewal of the authorisation of MON810 maize, conferring protection to the plant against certain insects, was adopted in June 2009. There are two other GM maize products – Bt Maize 1507 (filed by Pioneer) and Bt maize Bt 11 (filed by Syngenta) -, which also confer protection to the plant against certain insects. The favourable EFSA opinions were respectively adopted in January 2005 and April 2005 and draft decisions to authorise these two GMOs were voted on 25 February 2009 in the framework of the Regulatory Committee under Directive 2001/18/EC. No qualified majority was obtained. The fourth one is maize NK 603 (filed by Monsanto), which is tolerant to the herbicide RoundUp. EFSA adopted a favourable opinion on this product in June 2009.

From a procedural point of view, the next step for MON810 and NK603 would be the submission of a draft decision to the Standing Committee for Food Chain and Animal Health (SCoFCAH) (first step of the comitology procedure). Bt 11 and Bt 1507 are in the middle of the Comitology procedure, the next procedural step being the submission of decisions to the Council.

What improvements have been made to the environmental risk assessment of GMOs since the Council s request in December 2008?
The Commission and EFSA, together with the Member States, are working on the particular areas for improvement of the implementation of the GMO legislation, identified by the 2008 Environment Council conclusions.

The update of the EFSA guidelines for the environmental risk assessment is ongoing and covers the specific areas requested by the Council. Given the complexity of the topic, the need to ensure a broad consultation process and the large number of public comments (approximately 500), EFSA is expected to finish the guidelines in November 2010. The Commission will then discuss these guidelines with Member States to give them normative value with the Member States endorsement.

Furthermore, EFSA is engaged in dialogue with Member States and stakeholders, enabling them to contribute to its scientific work. EFSA has created a network of Member State experts to exchange scientific knowledge and experience. EFSA is also considering all Member States comments during the entire risk assessment process.

In addition, EFSA has a comprehensive set of internal mechanisms and working processes to safeguard the independence of the scientific work of its Scientific Committee and Panels, including a comprehensive policy on declarations of interest for its scientific experts. EFSA keeps this policy under regular review, and as encouraged by the Commission, will continue to strengthen the examination of the independence of its experts.

The Commission is analysing how to further reinforce the post-market environmental monitoring of GMO crops, in line with the provisions of the current legislation and the 2008 Environment Council conclusions.

When will the Commission finalise the report on the socio-economic implications of GMOs?
In December 2008, the Council requested the Commission to provide a report on the socio-economic implications of GMOs by June 2010 This report should be based on information provided by Member States, which have made an important effort to compile information on the socio-economic implications of GMOs and, notably, of their cultivation. But given that Member States contributions arrived later than expected, the Commission will finalize its report by the end of 2010. This report will then be submitted to the European Parliament and to the Council for consideration and further discussion.

Can we anticipate a speeding-up of the authorization process of GMOs and a rising of surface of GM cultivated areas in the EU?
There is no speeding up of authorisations or weakening of the rigorous environmental risk assessment requirements of the legislation. The proposal the Commission adopts today does not change these requirements. To the contrary, work on the implementation of the 2008 Council conclusions is since ongoing. Moreover, ensuring a safety assessment following the highest scientific standards and a reinforcement of the monitoring function were and remain priorities for the Commission as concerns GMO cultivation.

For more information http://ec.europa.eu/food/food/biotechnology/index_en.htm

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Commission’s Nationalisation of Approval for the Cultivation of GM Crops

– EuropaBio, Brussels, July 13, 2010 http://www.europabio.org

This afternoon EuropaBio provided industry’s initial reactions to Commissioner Dalli’s announcement of the Commission’s proposal to nationalise the authorisation of cultivation of GM crops.

Commenting on the proposal, EuropaBio Secretary General, Nathalie Moll, said: “EuropaBio recognised President Barroso’s commitment early on to develop a smart, sustainable and inclusive economy and we were also encouraged by the Commission’s goal of embracing responsible European innovation across all sectors. Furthermore, we appreciated the vision put forward by the Commission of enabling the EU member states to move forward on the issue of GM crop cultivation at their own pace. Central to this vision must be permitting those member states and their farmers who wish to embrace the benefits of GM crops the freedom to do so.”

Consequently, industry is disappointed that today’s proposal does not appear to provide a means of delivering this vision in that it disables rather than enables the application of beneficial and rigorously tested agricultural biotech products and technologies. We strongly believe that for the proposal to be workable it must be science-based, proportionate in its recommendations and non-discriminatory to those farmers that wish to choose to grow the crops that work best for them. Without due respect for these fundamental principles, the resulting policy will be detrimental to the overall sustainability and success of the European agricultural sector as a whole.

EuropaBio Director for Agricultural Biotechnology, Carel du Marchie Sarvaas, explained: “These proposals appear to give carte blanche to ban safe and approved GM crops in any country or region regardless of the needs or wishes of their farmers. In addition, the proposals will inject further legal uncertainty for those farmers that do wish to grow these crops. The upshot is that even as we contemplate a future fraught with the challenges of globalisation, climate change, food insecurity and shortage of natural resources, we will be denying our farmers the ability to use cutting edge technologies, already available to their counterparts outside the EU, to help them to deal with these same challenges”.

EuropaBio and its members remain committed to applying their expertise towards providing sustainable and beneficial products and technologies giving European farmers and consumers a greater choice in what they grow, buy and eat.