"The question of GMOs is way too important, not only for the farmers and the industry or the scientific world, but also in job terms... We should take a pro-active stance. We must explain to the people out there what they risk if we turn our back on this technology." - Franz Fischler
So the EUrocrats say lets promote GMOs and speed up their approval in return for more extensive labelling, while Krebs and the FSA -- who have built their whole case regarding GMOs on labelling and transparency (as opposed to investigating GMO safety!) -- say the EU's proposals on labelling are unworkable and should be watered down and opposed.
For the biotech industry this is clearly a win/win situation. For the poor old citizen...
1. EU freeze on GM crops set to thaw?
2. More Eurocrat urls
3. David BYRNE speech
4. Franz FISCHLER speech
1. EU freeze on GM crops set to thaw?
Environment Daily 1064, 20/09/01
The European Commission has made its strongest call yet for the EU's moratorium on new genetically modified (GM) crop approvals to be dropped as it prepares to restart the authorisation process. The EU regulatory committee that decides whether to grant market licences for new GM crops will be convened before the end of the year and asked to approve a host of applications, a Commission spokesperson told Environment Daily today. At an informal meeting of agriculture ministers in Belgium on Tuesday, health and agriculture commissioners David Byrne and Franz Fischler called on governments to "show leadership" on GMOs now that the Commission had presented proposals for comprehensive EU rules on the traceability and labelling of GM-derived foods (ED 26/07/01 http://www.environmentdaily.com/articles/index.cfm?action=a- article&ref=10371
Tuesday's meeting discussed new technologies in agriculture, focusing mainly on biotechnology. The GM debate had produced "more heat than light" with "too many false claims" made around GM-derived food products, Mr Byrne told ministers. In a thinly-veiled attack on a number of EU governments, Mr Fischler said: "It is not my understanding of political leadership to echo populist stances and play on fears in order to score cheap political points." Europe must "take a pro-active stance" and "explain to the people out there what they risk if we turn our back on this technology," he added. A hard-core bloc of six countries - France, Austria, Luxembourg, Denmark, Greece and Italy - has kept the moratorium in place but the Commission hopes its new proposals will persuade them to change their position (ED 17/07/00 http://www.environmentdaily.com/articles/index.cfm?action=a- article&ref=8041
On 16 October national experts will discuss the traceability and labelling proposal and prepare the ground for the regulatory meeting, where the first new licences for over two years could be granted. Follow-up: European Commission http://europa.eu.int/comm, tel: +32 2 299 1111, plus press release http://europa.eu.int/rapid/start/cgi/guesten.ksh?p_action.g-gettxt=gt&doc=IP/01/1280|0|RAPID&lg=EN
2. Eurocrat urls
- Byrne and Fischler call for political leadership on GMOs (de)
- New technologies in Agriculture - Biotechnology - David Byrne, Informal Agriculture Council, Alden Biesen, 18 September 2001
3. RAPID September 18, 2001
SPEECH: Mr David BYRNE European Commissioner for Health and Consumer Protection "New Technologies in Agriculture" -Biotechnology Informal Agriculture Council Alden Biesen, 18 September 2001 :
At the outset allow me thank the Presidency for organising this informal
Council on the theme of new technologies in agriculture. We have just heard excellent presentations that provide a global perspective on the issues of biotechnology and biomass. They provide a tremendous stimulus to our discussion and consideration of these issues. There is no doubt about the enormous potential of biotechnology. For instance, we can now treat children suffering from retarded growth, without risking contaminating them with Creutzfeldt-Jacobs Disease. Contrast this with the position when we had to rely on growth hormones extracted from cadavers. I need not remind you that the latter practice led to a number of tragic deaths of children. We can also alleviate the sufferings of haemophiliacs with unlimited sources of coagulation factors free from the HIV or Hepatitis C viruses, which have killed many patients. For that alone, I think we should be grateful to biotechnology. Take the situation on rare diseases. As most of them are caused by genetic disorders, the advances in gene technology will contribute very much to the understanding of the causes of these diseases and perhaps lead to cures.
However, the perceived absence of benefits to the final consumer is one of the main impediments to a more generalised social acceptance of the use of GMOs in agri-food production. Life sciences and biotechnology are in a stage of exponential growth. They open up a vast range of potential in terms of future benefits, competitive advantage, economic growth and employment opportunities. In line with the European Union's strategic goal of becoming the most competitive and dynamic knowledge-based economy in the world, the Commission is placing particular emphasis on the potential of life sciences and biotechnology. Only two weeks ago we published a consultative Communication "Towards a strategic vision of life sciences and biotechnology". This document is mapping out the wide range of issues linked to the application of biotechnology and raises many of the same questions as we are discussing here today. One of the key messages from this Communication is that the potential we are envisioning can only be realised if there is broad public support. We see an increasing need for awareness and enlightened policy decisions based on rational fact. Very often the debate on GMOs has generated more heat than light. We must ensure, as political leaders, that the unbiased facts on biotechnology are placed before our citizens to see and understand. Too many false claims have been made which do not reflect the science-based approach to food safety that I advocated since coming into office. I am, therefore, calling on all sides to have a rational debate and to take a balanced approach. In this assembly, I am sure that I do not need to remind you that the Commission is committed to the development of sound and coherent policies in the general interest of Europe and our citizens. But the legitimacy of that commitment can only be fully realised by building widespread consensus with all stakeholders in Europe public authorities, scientists, business, consumers and the body politic at large. All players have to confront their responsibilities and obligations towards their fellow partners. Through this process, we are seeking to develop the strategic potential of life sciences and biotechnology over the long-term. This debate must avoid the pitfalls of short-term solutions Turning now more specifically to the questions the Presidency has framed. Last December's OECD report pointed out that, at this stage, strong conclusions on the economic impacts of genetically modified crops cannot be drawn.
Though expected profits are often considered a major factor in the adoption of genetically modified varieties, available studies do not, in general, give consistent evidence of profit increases for adopters compared to non-adopters. Results vary across regions, crops and years. Increased costs of the technology are not uniformly compensated for by yield increases or reductions in pesticide and herbicide use. Moreover, contrary to what is the case for pharmaceuticals, most of the GMOs currently on the market are not geared to deliver specific, clear benefits for the consumer. From a consumer point of view, this has given rise to scepticism, independent from safety questions, and I am sympathetic to the fact that for some applications of biotechnology, the benefits may not be so obvious at this stage. I believe, however, that the public attitude towards GM food can change once products with clear benefit to consumers are marketed. However, before we even get to that stage, we must ensure that the optimal regulatory environment is in place. Consumers, whether they be farmers or shoppers, must have confidence in the regulatory framework. A high level of protection, consumer choice and transparent, uniform and efficient authorisation procedures are key elements in fostering social acceptance and trust in the application of biotechnology to food and feed. In this regard, I would like to draw your attention to the two proposals on biotechnology adopted by the Commission in late July and which are based exactly on these principles. Our first legislative proposal, which concerns GM food and feed, ensures a high level of protection requiring genetically modified food and feed, including food and feed which are produced from a GMO, to undergo a scientific risk assessment prior to the placing on the market, enables the consumer to exercise a freedom of choice by reinforcing current labelling requirements and provides for improved, transparent and streamlined Community level procedures for authorisation involving the European Food Authority. The second proposal on traceability, establishes harmonised and coherent Community requirements for traceability of GMOs as well as for GM food and feed. Safety is essential for the future success of biotechnology in Europe. In the minds of the European public, safety is the most important ingredient of their food. Compromising on food safety is not the way forward, and, as you would expect, I do not intend to go down that route. The overarching principle of the new proposal is that GM food and feed must not present a risk for human health, animal health or the environment. Therefore, GM food and feed have to undergo mandatory pre-market authorisation involving a scientific assessment of potential risks. Only if concluded to be safe should such products be allowed to be placed on the market. Whilst this principle is not new as regards genetically modified food, the proposal establishes for the first time the same, clear and stringent rules at Community level for feed derived from GMOs. There are further important principles for authorisation in respect of GM food or feed. These are that they must not mislead the consumer or the user, they must not differ from foods and feeds which they are intended to replace to such an extent that their normal consumption would be nutritionally disadvantageous for consumers or animals. In the case of feed, it must be established that it must not harm the consumer by impairing the distinctive features of animal products. Learning from the US experience with StarLink, the proposal provides that GMOs likely to be used as food and feed have to be authorised for both uses or not at all. Our intention is to prevent a StarLink type of situation occurring in Europe. The proposal also establishes that the need for post-market monitoring of GM food and feed has to be evaluated during the risk assessment and that monitoring requirements can be imposed as part of the authorisation, where appropriate. I do not intend this morning to go into the detail of our proposals. I will circulate some summary details of other aspects of our package, including how the European Food Authority will carry out scientific risk assessments as part of the authorisation procedure, revised labelling requirements, and how we propose to handle adventitious presence of GMOs. The two proposals, together with the recent adoption of the revised legislation on the deliberate release of GMOs into the environment, will, I believe, build up public confidence by responding to questions and concerns raised by the general public. The proposals provide for a high level of protection for human health and the environment and will enable consumers to exercise their freedom of choice. However, it does not end here. I am still working on future proposals notably in the seeds sector to complete the regulatory picture. I see the proposals, which I have briefly presented to you today, as an integrated part of the strategic vision which I hope will contribute to a rational and balanced debate about the future of biotechnology in Europe and lead to increased public acceptance of the use of biotechnology. May I thank the Presidency again for their initiative in organising this informal Council around the theme of new technologies in agriculture. I regard this as an important input into the wider debate the Commission has initiated about the future potential of life sciences and biotechnology.
Annex Summary details of draft Regulations on GM Food/Feed and Traceability European Commissioner David Byrne Authorisation Procedure
In order to streamline and improve the efficiency of the current authorisation procedure for GM foods, we envisage that the European Food Authority will carry out the scientific risk assessment. The procedure will cover both the environmental, human and animal health aspects of GM food and feed. Companies wishing to market a GM food or feed are required to submit an application to the European Food Authority. Apart from scientific data to demonstrate the safety of the product, the application also has to include a method for detection. The detection method is to be validated by the European Reference Laboratory on GMOs and will be made available to control authorities to facilitate their work. Decisions to authorise GM food and feed shall be taken at European level on the basis of the scientific opinion of the European Food Authority. The proposal includes the establishment of a Community Register of Genetically Modified Food and Feed, which should contain information concerning all authorisations. To ensure transparency the Register shall be made available to the public. Authorisations shall be limited to 10 years, being renewable for 10 years periods, upon application to the European Food Authority. The company that holds an authorisation has to ensure that any conditions or restrictions, which have been imposed in the authorisation, are respected. Transparency of the decision-making process and the involvement of the public in the authorisation process will also be improved. A summary of the application for approval and the opinion of the European Food Authority shall be made available to the public and the public may make comments to the Commission before the final decision to authorise a GM food or feed. In order to further ensure clarity, transparency and a harmonised framework for authorisation, the proposal does not include the simplified procedure enshrined in the Novel Foods Regulation for foods that are considered to be substantially equivalent to existing foods. The use of this regulatory short-cut procedure has proven to be controversial in recent years.
There is now international consensus that, whilst substantial equivalence is a key step in the safety assessment process of GM foods, it is not a safety assessment in itself. Labelling All foods, whether pre-packaged or not, are subject to extensive labelling requirements under EC legislation. The objective of the new proposal is to inform consumers about the exact nature and characteristics of the food to enable them to make individual choices. The purpose of labelling is not to inform the consumer about the safety or lack of safety of a food. If a food is unsafe it cannot be placed on the market. There is no question of allowing it on the market but warning the consumer about a potential hazard. The current EU labelling scheme provides that GM foods have to be labelled if traces of DNA or protein resulting from the genetic modification are detectable in the final product. I believe that we can do better than that. The choice that I want to give Europe's consumers is very simple - "I can choose whether or not to buy food produced from a GMO". The Commission's proposal reinforces the labelling of genetically modified products by ensuring labelling of: All foods produced from GMOs, irrespective of whether DNA or protein of GM origin is detectable in the final product.
This will then comprise highly refined oils and products composed thereof; All genetically modified feed. For example it will require labelling of corn gluten feed produced from GM maize. These requirements respond to an overwhelming need to enable the consumer or users to exercise freedom of choice. Moreover, I believe that an appropriate labelling scheme is one of the key issues in ensuring and fostering increased public confidence and acceptance of the application of gene-technology in the agri-food sector. Traceability The proposal on traceability provides the basis for accurate labelling and facilitates withdrawal of GMOs in case an unforeseen risk should come to light. As you know the revised Directive on the release of GMOs into the environment introduces mandatory monitoring of GMOs. The traceability proposal is also designed to facilitate such monitoring. Adventitious Presence An issue which arises from the cultivation of GMOs is the possibility of the presence of minute traces of unauthorised GMOs in food and feed. These traces may be technically unavoidable during cultivation, harvest, transport and processing. Whether we like it or not this has become a reality. This is not an issue that is particular to GMOs. In the production of food, feed and seed, it is practically impossible to achieve products that are 100% pure. The current EU labelling provisions already addresses this problem by providing for a 1% threshold for adventitious presence of traces of approved GM material and a basic element of our legislation on seeds is to provide purity criteria to ensure legal certainty for seed producers and farmers. The present proposal also takes into account the technically unavoidable traces of GM material.
Apart from providing for the possibility of establishing a labelling threshold, it sets up specific conditions under which technically unavoidable presence of unauthorised GMOs could be permitted. In the EU, the Scientific Committees have already assessed a number of GMOs and concluded that they do not pose a danger to the environment or to human health. However, these GMOs are still pending final approval and some of them have now been awaiting approval for quite some time. The proposal allows for these GMOs which have received a positive opinion from an EU Scientific Committee to be present in a food or feed up to a maximum of 1%
4. RAPID September 18, 2001
SPEECH:Dr. Franz FISCHLER Member of the European Commission responsible for Agriculture, Rural Development and Fisheries Integration of new technologies into agriculture Informal Agriculture Council meeting in Belgium Alden-Biesen, 18 September 2001
Minister Neyts-Uyttebroeck, ladies and gentlemen, dear colleagues, The integration of new technologies into agriculture is on the agenda of our informal meeting today. The choice of this theme for our discussions shows that we have our finger on the pulse of the newest challenges facing agriculture in the near and far future. I can only thank and congratulate the Belgium Presidency for putting this issue on the table, because as Europeans we need to follow developments in the world so that we can respond or, even better, take a lead in shaping policies which are based on our visions and convictions. Policies which are in line with our idea on a future-oriented, sustainable and multifunctional agriculture. No contributions from our side are as damaging for us as a 'wait-and-see' approach, or reacting with fear of change and new developments. We have the choice between actively shaping future policies, or being confronted by the policies shaped by others. The second option would be a very damaging one for our farmers, our model of agriculture, our research workers and for our consumers and businessmen alike. The Presidency has made a start by putting two items on the agenda today which do deserve specific attention in this respect: genetically modified organisms and bio-fuels. As far as GMOs are concerned, I will refrain from specific comments since my colleague David Byrne recently put forward two specific proposals on the subject. But I would like to underline that I am glad that the Commission was able on 25 July to approve the proposals on traceability and labelling of GMOs and on regulating genetically modified food and feed. Both regulations aim at taking into account WTO rules and respect of the EU's international commitments. Community businesses will only be able to seize the opportunities which biotechnology provides if consumers can have confidence in it. These two proposals are an important step in gaining this confidence. Biotechnology is evolving very rapidly and new plant varieties in this field can lead to specific quality improvements or new and useful characteristics in plants. But the technology can also bring risks, and this is the challenge to policymakers.
They must take steps to avoid any negative effects on health, agriculture and the food sector, and the environment. The speed with which science is advancing calls for equal speed in regulation. Another of the main problems is maintaining the viability of conventional and organic farming and safeguarding their sustainable coexistence with GM crops. Farming needs to be conducted in a way which prevents contamination beyond the levels prescribed by the relevant regulation. Appropriate measures at the farm production level to minimise potential contamination should be evaluated and the economic consequences analysed. The contamination of organic crops is a more difficult question. Our organic farmers must not suffer any negative impact. Further research in this field is important for the future. Let me turn now to the second issue on the agenda today, bio-fuels. Fulfilling the Kyoto targets is high on the EU agenda. Accordingly, we need to find ways of achieving these targets. Through expanding the use of bio-fuels, agriculture can make an important contribution to reducing carbon dioxide emissions. This is also in line with the sustainable development strategy of the Union. The recent reforms of the common agricultural policy included a comprehensive programme for promoting the cultivation of biomass - in particular through allowing non-food crops on set-aside land. At the same time, the Agenda 2000 reforms contributed to providing biomass at a price which would help it in the long run to become a competitive raw material for industrial use. I would like to emphasise also the manifold possibilities under the rural development programmes in particular investment aids that can help to promote the production and processing of biomass. At all events, the CAP has contributed to making bio-fuels, at 66%, the biggest single renewable energy resource. However, after initially high growth rates in the use of bio-fuels, we can now see that they are just keeping pace with the expansion of other renewable energy sources.
The clear discrepancy between prices for bio-fuels and for fossil energy continues to present a major handicap. Still, we should remember that this price gap is only seemingly a result of a real competitive disadvantage of bio-fuels.Fossil energy sources benefit from the circumstance that market prices do not reflect the external costs of using fossil energy such as carbon dioxide emissions and the exhaustibility of resources. Political measures are required to bring about a true price ratio. A better macroeconomic balance can be arrived at through taxes on fossil fuels, de-taxing of bio-fuels, or compulsory market shares for bio-fuels. The Commission will be deciding in the next few weeks on an initiative for significantly expanding the use of bio-fuels by introducing compulsory market shares for bio-ethanol and bio-diesel used in the transport sector. Such an initiative represents for EU agriculture both an opportunity and a challenge. It is an opportunity because the production of bio-mass offers new sources of farm income. It is a challenge because I am convinced that those income opportunities will not be realised without considerable efforts on our side. An increasing demand for bio-fuels will result in additional price incentives, which represent an incentive also for our competitors on the world markets to get involved in exporting processed bio-fuels or the raw materials for them to the Union. The possibilities for safeguarding an EU market share through trade measures or crop-specific direct payments are particularly limited under existing WTO rules. And even the possibilities provided by the set-aside privilege for non-food crops will not allow us to expand this sector significantly because we are bound by the Blair House limits on potential by-products. Even for renewable resources, the directions pursued under Agenda 2000 remain valid: Alongside food crops, we need to become competitive in the production of bio-fuels. We must ensure that our products can succeed in the marketplace. Competitive prices are one precondition for achieving the competitiveness of our biomass production vis-a-vis raw materials of fossil origin as well as vis-a-vis competitors from outside the Union. In addition, we need to rely on an ambitious rural development policy which provides a comprehensive framework for promoting the production and processing of biomass through investment aids for new technologies and marketing. Last but not least, an important contribution can be made by research, since subsequent productivity gains in both the primary production of biomass and the final use of energy crops will call for a major research effort now.