Home Page Link AgBioWorld Home Page
About AgBioWorld Donations Ag-Biotech News Declaration Supporting Agricultural Biotechnology Ag-biotech Info Experts on Agricultural Biotechnology Contact Links Subscribe to AgBioView Home Page

AgBioView Archives

A daily collection of news and commentaries on

Subscribe AgBioView Subscribe

Search AgBioWorld Search

AgBioView Archives





February 6, 2006


AgBioView Special: WTO Ruling - US vs. EU


Today in AgBioView Special on WTO Ruling from http://www.agbioworld.org - February 6, 2006

* Three Cheers for WTO Decision on Biotech Food
* Archives of AgBioView from 2003 on the WTO Case
* CEI Praises Major WTO Decision on Biotech Food - Restores Consumer Choice
* Europe's Biotech Food Ban Must End
* Ag Biotechnology: Safe, Effective and Unfairly Blocked By EU
* Science, Politics, and the GM Debate in Europe
* EU Answers Questions on the Regulation of GMOs
* Time for the GM Moratorium to Go


Three Cheers for WTO Decision on Biotech Food

- Gregory Conko, CEI, Feb. 6, 2006 http://www.cei.org/gencon/019,05127.cfm

What do an Iowa corn grower, a Thai rice farmer, and a Dutch grocery shopper have in common? You may think the answer is "not very much." If you do, think again. Despite being separated by thousands of miles and a deep cultural gulf, all three should be cheering today’s World Trade Organization ruling against European biotechnology restrictions.

On February 7, the WTO is expected to release its findings in a long-running dispute between the United States, Canada, and Argentina over European regulation of bioengineered, or "Genetically Modified," food. Today’s decision confirms that several of Europe's biotechnology rules have no scientific basis and therefore unfairly restrict imports from the rest of the world.

Since 1998, European shoppers have been forbidden access to less expensive, high quality foods that are grown on every other continent and eaten daily by millions of people. The EU has refused even to consider approving many new bioengineered products, despite the fact that each has been judged safe by its own scientific committees.

It’s bad enough that European consumers have been stripped of their freedom to choose, but the impacts extend far beyond Europe’s borders. Commodity shipments and packaged foods have been turned away from the European market merely for containing bioengineered ingredients. U.S. farmers alone have lost an estimated $300 million worth of grain exports every year for half a decade.

That could soon change, but the biggest beneficiaries will be poor farmers in less developed countries. Many of the same bioengineered crops grown throughout the United Stares are already helping poor farmers in South Africa, India, China, and the Philippines combat often-voracious insects while reducing pesticide use or eliminating it altogether. Sadly, though, the benefits of biotechnology have not spread widely through the developing world in large part due to the European market restrictions.

For example, European importers have warned Thai government officials against authorizing bioengineered rice varieties lest the country forfeit that important market for its $2.5 billion export crop. Uganda has stopped research on bioengineered bananas and postponed their introduction indefinitely. Dozens of developing world governments have awaited the outcome of this case to see whether their farmers would be allowed to share in the benefits of the biotechnology revolution.

For years, the European governments have rationalized their blatantly anti-consumer policies as promoting consumer choice. But, refusing to approve any bioengineered foods hardly counts as promoting consumer freedom.

Now, EU policymakers will be forced to confront the fact that their groundless biotechnology restrictions flaunt the scientific consensus that food biotechnology is a safe and effective way to increase yields, lower costs, and protect the environment. A decision by the 140-member World Trade Organization will send an important message from the international community that it’s time for the EU’s groundless and genuinely harmful biotechnology restrictions to go.


Archives of AgBioView from 2003 on the WTO Case:





CEI Praises Major WTO Decision on Biotech Food - WTO Restores Consumer Choice

- CEI Staff, February 6, 2006 http://www.cei.org/gencon/003,05128.cfm

Washington, DC, February 6, 2006—The Competitive Enterprise Institute applauds the World Trade Organization’s expected February 7 finding that European bans and other marketing restrictions on bioengineered foods have no scientific basis and violate global treaty obligations by denying consumers choice.

"This decision is a triumph for consumer freedom over interest group lobbying," said Gregory Conko, a CEI senior fellow, in anticipation of the ruling.

The forthcoming WTO decision is in response to a suit filed jointly by the United States, Canada, and Argentina in May 2003 and joined by eight other countries. The complaint alleged that on-going national bans on biotech foods, along with an EU-wide moratorium on the approval of biotech products, violated provisions of the General Agreement on Tariffs and Trade (GATT) and three other treaties enforced by the WTO.

"The bans forbid shoppers from choosing biotech foods, even though European regulators and countless government-funded studies show biotech foods to be as safe, or safer, than conventional counterparts," said Conko. The six-year moratorium on biotech product approvals ended in 2004, after the European Union implemented what it claims are the strongest biotech food regulations in the world. Those new regulations are not a subject of the WTO suit, but are also widely believed to violate various trade treaties.

"The decision was never really in doubt, but its global impact could be huge," Conko explained. "The European restrictions have hindered the ability of poorer countries to take a part in the biotechnology revolution." Countries in Asia, Africa, and South America have supported the United States position, because the EU restrictions also prevent them from growing biotech crops for export to the European market.

"With the voice of the world community now clearly on the record, we hope the Europeans will quickly dismantle their bans and let science-based policy and consumer freedom prevail," said Conko.


Europe's Biotech Food Ban Must End

- Alan Caruba, Enter Stage Right, Jan. 23, 2006 http://www.enterstageright.com/

Since May 2003, the United States, joined by Canada and Argentina, has pursued a World Trade Organization (WTO) dispute settlement process against the European Union (EU) regarding its de facto moratorium banning biogenetically altered food crops.

The main opponents of such crops include the usual "environmental" organizations for whom any progress toward eliminating famine and disease is regarded as an increase in the Earth's human population. If you're a member of the Earth Liberation Front, Friends of the Earth, Greenpeace, the Center for Food Safety, and the Organic Consumers Association, among others, the scientific advances of biotechnology are bad news.

If you are a member of the human race, however, genetically-modified foods (GMOs) means (1) an increase in agricultural productivity wherever such crops are grown; (2) crops that can resist the effects of drought, a common cause of crop failures; (3) the bioengineered increase of nutrients and a decrease of saturated fats in various food crops; and (4) the reduction of the use of insecticides and herbicides. Farmers will tell you GMOs, in addition to reducing the amount of water needed to grow certain crops, contribute to the reduction of soil erosion caused by agriculture.

So why is the European Union refusing to permit the importation and use of GMOs? Alex Avery of the Hudson Institute probably said it best when he described it as "technological apartheid." While the Europeans are well fed, the fate of people in Africa and other Third World nations are of little importance to them for purely economic reasons. Avery points out that, "More than half of the EU's collective budget is gobbled up by farm subsidy costs, so Europe has done all that it can to avoid productivity-enhancing technologies for cost savings."

In the interest of keeping GMO crops from America and other nations out of Europe, the EU has declared that such crops may pose a health risk. They say that genetically modified crops, if grown in Europe, might "contaminate" organic crops. Baloney! For all the reasons stated above, GMO crops not only do not pose a threat to organic crops, except in terms of greater yields, they hold the potential for the virtual elimination of famines that cause the deaths of millions worldwide every year.

The EU represents the fourth largest market for U.S. agricultural exports. The earnings were projected by the U.S. Department of Agriculture at $7 billion for 2005, nearly 12 per cent of all the U.S. agricultural exports. The main export products are soybeans, tobacco, and animal feed, including corn gluten.

To date, the EU has not offered a scintilla of scientific evidence to justify the market bans imposed by some member states. The whole point of the World Trade Organization is to end frivolous bans in order to facilitate, well, world trade! The WTO even has an Agreement on the Application of Sanitary and Phytosanitary Measures that requires "sufficient scientific evidence" to support trade-restrictive regulations on crops and food products."

Speaking in May 2003, President Bush said, "Our partners in Europe have blocked all new bio-crops because of unfounded, unscientific fears. This has caused many African nations from investing in biotechnology for fear that their products will be shut out of European markets. European governments should join, not hinder, the great cause of ending hunger in Africa."

The opponents of GMOs will tell you this is about consumers versus agricultural corporations or they will continue to fear-monger about the safety of GMO foods. It's a government-to-government confrontation over food exports and more than a dozen nations, including South Africa, Argentina, Chile, Canada, Australia, Columbia, El Salvador, Honduras, New Zealand, Peru, Uruguay, Mexico and Egypt, have expressed support for the U.S. initiative currently waiting a still-delayed decision by the EU.

Putting aside the financial aspects of the ban EU member states have imposed, the issue of GMO safety has long since been decided. In 2004, the National Research Council, a division of the National Academy of Sciences, issued a report in which it found that genetic engineering is "not an inherently hazardous process", calling the fears of the anti-biotech crowd "scientifically unjustified." The report in fact repeated findings that date back to 1987.

The United Kingdom-based Institute for Food Science and Technology found that "Genetic modification has the potential to offer very significant improvements in the quantity, quality and acceptability of the world's food supply."

Not only is there no cause to fear GMO food products, since the WTO case was launched in 2003, the planting of biotech crops has increased around the world at unprecedented rates. In 2005 alone, more than 81 million hectares were sown with biotech crops by more than eight million farmers in 17 countries; a 20 per cent increase over the previous year. They are even being planted in European nations where farmers in Spain, France, Portugal, Germany, the Czech Republic, and Romania are taking advantage of the benefits they represent.

While a favorable decision by the WTO opening European markets to GMO food choices will be good for consumers, the real winners will be the world's farmers who have suffered the most under these de facto trade restrictions.

So now we wait for the EU to do, at last, the right thing, the moral thing, by ending the GMO ban it has imposed.

Alan Caruba writes a weekly column, "Warning Signs", posted on the Internet website of The National Anxiety Center.


Agricultural Biotechnology: Safe, Effective and Unfairly Blocked By EU

- Trade Facts, Office of the United States Trade Representative (file 159_8795) http://www.ustr.gov, January 2006

EU Moratorium on Biotechnology Not Based on Science Since the late 1990‚s, the EU has pursued policies that undermine the development and use of agricultural biotechnology.

Beginning in October 1998, the EU adopted a moratorium on all approvals of new varieties of biotech crops. Because new biotech varieties are continually introduced, and because crop varieties are commingled on export, the EU moratorium had the effect of barring many U.S. agricultural products, including most U.S. corn, from EU markets.

The EU moratorium was based on political concerns, and was not grounded on any health or safety risks related to biotechnology. To the contrary, there is no internationally recognized science that demonstrates any safety issues associated with the use and/or consumption of approved biotech products.

Under WTO rules, when WTO members establish approval processes, they take on obligations to operate those approval processes in a manner that is based on science and not subject to unnecessary delays.

The United States believes that the EU adoption of a biotech moratorium unwarranted by valid scientific concerns is plainly inconsistent with these fundamental WTO obligations.

For years, the United States refrained from bringing a WTO case, because the EU continually assured us that the moratorium would soon be lifted. But the EU was not able to overcome its internal political pressures and lift the moratorium.

Finally, in August 2003, the United States - joined by Argentina and Canada - challenged in the WTO the EU‚s moratorium on approving biotech varieties for sale or use in the EU. The United States and our partners took the case to ask that our farm products are given a fair, rules-based scientific review.

The WTO case alleges that the EU‚s moratorium violates WTO rules by blocking U.S. exports without a valid scientific basis and imposes undue delay on approvals.

The United States believes it has shown that the EU's moratorium is based on political expediency, rather than on health or safety concerns. Indeed, the EU's own scientific authorities consistently find biotech varieties to be safe. According to the EU‚s regulatory process, these varieties should have been approved for sale and use in the EU, but the EU has failed to approve them.

Effects of the Moratorium Go Beyond Europe
* In addition to blocking U.S. grain exports to the EU, Europe‚s actions unfairly discriminate against safe and innovative products, and discourage further research and development in biotechnology.

* Biotechnology has the potential to help farmers meet challenges posed by harsh climates and disease. Virus-resistant potato and papaya varieties are already helping farmers achieve higher yields. Research continues on salt tolerant and drought resistant crops.

* Biotech crops with nutritional enhancements like golden rice may help provide the poor with healthy, more complete diets.

* But restrictions like those in the EU discourage investment in biotechnology, for fear that these products will not find markets that are open to them. Biotech Crops are Safe

* Consumers in the United States have been safely consuming nutritious foods that contain biotech ingredients for a decade.

* The U.S. regulatory process ensures that all biotech products that are commercially grown, processed, sold and eaten are as safe for the environment and for human and animal health as their conventional counterparts.

* The UN Food and Agriculture Organization and WHO found that there were no greater risks associated with biotech than conventional plants and foods. Even the European Commission for Research has arrived at similar conclusions when comparing biotech to conventional food sources.

Biotech Crops Deliver Better Yields, Promote Development and Help the Environment
* Biotechnology is part of the long tradition of agricultural innovation and plant breeding to develop higher yielding, disease-resistant crops.

* Farmers worldwide have recognized the economic, agricultural and environmental benefits of biotech crops.

* Agricultural biotechnology is important to the United States and the world. It offers the potential to developing countries to meet their food security needs and to lift them from subsistence agriculture.

* Agricultural biotechnology also provides environmental benefits. Adoption of biotech varieties has significantly reduced insecticide and herbicide use, and has allowed many farmers to adopt "no till" farming practices, thereby reducing soil erosion and water use. Scientists continue to develop crops that resist drought and disease.

* Poor farmers in developing countries are growing more biotech crops every year. More than 8.25 million farmers around the globe use biotech seeds. 90 percent of those were resourcepoor farmers living in developing countries.

* The UN Food and Agriculture Organization and the World Health Organization both note biotech‚s value in creating sustainable development and providing reliable and safe food sources, especially for poor countries. Better yields generate better incomes -- another benefit to the nearly 7.4 million poor farmers in developing countries who grow biotech crops.


Science, Politics, and the GM Debate in Europe

- Francesca Tencalla, Regulatory Toxicology and Pharmacology. Vol. 44, Issue 1, Feb. 2006, Pages 43-48 (thanks to Dr. Vivian Moses). Excerpt below.. Full text and figures at http://www.sciencedirect.com

Abstract: Europe today stands at a crossroad, facing challenges but also opportunities. In its intent to make Europe a leading technology-based economy by 2010, the European Commission has identified biotechnology and genomics as fields for future growth, crucial for supporting the agricultural and food processing industry. Since first commercialization in 1996, GM crop areas have grown at double-digit rates, making this one of the most rapidly adopted technologies in agriculture.

However, in contrast to other world areas and despite European Commission support, Europe has found itself 'bogged-down' in a polemic between opponents and supporters of plant biotechnology. As a result, planted areas have remained small. This stalemate is due to a lack of political leadership, especially at the Member State level, all the more surprising in light of European early development and competitive advantage with crop biotechnology. This situation proves once again that, for cutting-edge innovations, a solid science base alone is not sufficient.

Acceptance or rejection of new technologies depends on interlinked political, economic, and societal factors that create a favorable or unfavorable situation at a given time. This article will look at GM crops in Europe and the role science and politics have played in the introduction of crop biotechnology.

1. Vision 2010: Europe as a leader in technical innovation
Today, Europe faces many challenges of political, economic, and social nature. At a time of intense competition from other world areas, the European Union (EU) is reshaping itself, expanding and continuously adapting its legal and environmental framework.

In a recent publication (European Commission, 2004), European Research Commissioner Phillippe Busquin restated the EU's March 2000 Lisbon European Council objective of becoming the "most competitive and sustained knowledge-based economy by 2010." One of the key elements to achieving this is maintaining and building on the EU's scientific and technological diversity and excellence, acting as a magnet for top researchers and innovative companies that would otherwise develop their activities elsewhere.

Two fields identified as crucial in this context, not only by the EU but also by individual Member State governments (see Boxes 1 and 2), are biotechnology and genomics.

Box 1--Tony Blair at the European Bioscience Conference (November 2000)
"The science of biotechnology is likely to be to the first half of the 21st century what the computer was to the second half of the 20th century. Its implications are profound, its potential benefits massive… Britain is well placed to keep our lead in Europe. I want to make it clear: we don't intend to let our leadership fall behind and are prepared to back that commitment with investment."

Box 2--Edelgard Bulmahn, German Minister for Education and Research (November 2003)
"Biotechnology is one of the most innovative fields of the 21st century. We expect that, from now to 2020, biotechnological methods will be involved in about half of all important innovations."

Applied to crops and food singly and in combination, these technologies will determine the future competitiveness of Europe's agricultural and food processing industries. This is of no small importance given that the agri-food industry is the leading industrial sector in the EU. It represents a €600 billion annual turnover, utilizing a fifth of the Union's land. It is also the continent's third largest employer, with 2.6 million jobs (excluding farmers) mainly in small to medium-sized enterprises (SMEs) (CIAA, 2004).

Let us therefore take a closer look at plant biotechnology and the increasing role it plays in Europe.

6. The European approval system
The ongoing debate in Europe is having a series of wide-ranging consequences that directly impact the objective of becoming a leader in technical innovation. Although the European Commission and certain governments strongly support moving forward with plant biotechnology, not all Member States stand united behind the decision. This has brought the regulatory system in place to a grinding halt. In 1998, six countries installed a "de facto" moratorium, stopping all new product approvals until the existing legislation governing questions relating to environmental monitoring, traceability, and labeling were revised.

Since 2003, new rules and guidelines are in place to address these questions but the system is still moving forward only very slowly. Where required, implementation into national laws has not been timely. In some cases, national measures have been inconsistent with the stated objective to support plant biotechnology and/or much more restrictive than required by EU legislation (see Box 3). In addition, there have been repeated destructions of field trials by anti GMO campaigners who have seldom been held to account by the law. In consequence companies and even public bodies have found it to be effectively impossible to conduct research or development with any real prospect of bringing a product to market in Europe in a timely fashion. This has led to biotech companies closing their European operations and moving R&D facilities to other world areas more receptive to GM research and offering real opportunities to place new products into the market.

The net consequence of this is a loss of investment in Europe with a knock-on effect for university students, employment, and overall competitiveness.

Box 3--Statement of the DFG (German Research Foundation) on the draft legislation to reform the law on genetic engineering in Germany (August 2004)

This draft legislation is intended to implement EU Directive 2001/18/EC on the deliberate release into the environment of genetically modified organisms (GMOs). The Directive requires Member States to take the precautionary principle into account (Article 8) when implementing the "appropriate control of risks" when GMOs are released. As part of the regulation of the release and placing on the market of GMOs, the draft legislation introduces an extension of the objectives of the law (Article 1 clause 2 new version), namely the principle of "co-existence," which is defined as co-existence of "agriculture using genetic engineering with conventional and ecological agriculture."

The vast majority of the following individual regulations nevertheless contradict the stated objective of the law. They present obstacles due to disproportionate conditions, which in practice--as the sum of the direct and indirect consequences of the planned regulations--will affect only one of these three forms of agriculture, namely the use of genetic engineering. Not only the agricultural use of "green genetic engineering," but also its use in research will be excluded, not according to the law, but by the predictable effects of the new regulations.

Today, a few crops recently received, or are on the verge of receiving, approval for import into Europe but actual planting of new GM crop varieties remains far on the horizon. This situation is contradictory; although the imports provide essential grains often at a lower price than home production, the lack of planting approvals sends a negative message to European farmers who are not able to take advantage of the benefits of the technology.

7. What are the consequences?
As a result of this complex situation, Europe is progressively losing market share and, due to declining investments from large organizations, any near-term ability to be competitive in the field of biotechnology. The emerging gap between the EU and its main competitors will affect not only the European science and technology base, but also industry, consumers and farmers.

There are many different measurable parameters to demonstrate the already considerable impact on European research. The number of notifications for field trials in across the EU15 (JRC, 2004) peaked at 264 in 1997, then fell to only 56 in 2002 (Fig. 1) and 23 in 2004. In contrast, there are around 900–1000 notifications of GM trials in the US each year (Mitchell, 2003). According to a recent Commission survey of private biotech companies and public research institutes (European Commission, 2003), 39% of European research projects in this field have been aborted in recent years. In the private sector alone, the figure was as high as 61%.

Faced with overly strict political and regulatory frameworks, university and industry R&D is moving to other world areas such as the USA, Japan, and China where long-term strategies for exploiting the potential of plant genomics and strengthening the positions in related markets are in place. Each year, thousands of Europeans go to study in the US and over 70% remain there to pursue their careers; it is estimated that nearly 40% of the scientists working in the US today are of European origin (Mettler, 2004). European biotechnology SMEs are more likely to enter into research collaborations with US companies that their EU counterparts and are also turning more and more to customers outside the EU (Bioscience Law Review, 2004). Furthermore, companies of all sizes are relocating their research activities and investments to these countries, as well as India and Argentina.

Recent examples include the Swiss agrochemical company Syngenta, which announced in July 2004 its intention to relocate its UK agricultural biotechnology research operations to North Carolina (US). Also, BASF, the world's largest chemical company, has threatened to move its GM crop research to the USA unless Europe becomes more receptive to new technologies. In an interview with the Financial Times (12 July 2004), Jurgen Hambrecht, chief executive BASF, said the German chemicals giant could not afford to keep investing in research if there was no market for its products. He further added that "the EU's 'Lisbon' aim to make Europe the world's most competitive economy by 2010 stood no chance of becoming a reality unless politicians were prepared to accept that the benefits of a new technology inevitable carry some risks."

Finally, the recalcitrant attitude towards biotechnology is expected to affect also the 15 million European farms in the 25 Member States and the European food industry. In a situation where agricultural output is less technologically competitive and Common Agricultural Policy subsidies are decreased and even eliminated, the growth of alternative niches such as the organic food market will not be able to compensate for a shrinking share of conventional and GM markets in Europe. Strong price competition coupled with loss of import protection and tariff reductions could lead to a shift from European products to imports, effectively limiting the range of EU consumer lifestyle and health choices.

In the near future, European consumers including farmers themselves risk being left with the choice of either buying local products at much higher prices or going for cheaper imports, all because of an unsubstantiated fear of GM products.

Rather than a leading position in the biotechnology and genomics field, Europe therefore faces the deterioration of its R&D base, the loss of markets for European agricultural products and an increased dependence on food and feed imports (Mitchell, 2003). European industry's ability to contribute to agricultural innovations and a biotechnology-based economy may see itself severely restricted.

8. Conclusion
Europe is at a crossroads and there are enormous opportunities to be grasped. Biotechnology and genomics, in particular relating to plants, have been identified as fields for future growth, crucial for supporting the agricultural and food processing industry, Europe's main economic sector. However, in contrast to other world areas which are moving ahead and investing heavily, Europe has found itself 'bogged-down' in a heated, long-winded, and often acrimonious debate between opponents and supporters of these technologies. In the meantime it is losing its competitive edge to other regions of the developed and developing world.

The situation in Europe proves once again that, for all cutting-edge innovations, a solid science base alone is not sufficient. Acceptance or rejection of the new technology depends on many interlinked political, economic, and social factors that create a favorable or unfavorable climate at a given time. Clearly more research is required on societal responses to the application of new technological innovations. Overall a better understanding of peoples' attitudes and values is needed.

Despite the competitive advantage Europe once had in the field of plant biotechnology, the first GM products to reach the market came at a time of confusion and strong skepticism towards politicians, industry, and scientists. As a result, the debate concerning GM crops has been dominated by the risks, while the positive economic, environmental, and health aspects have been ignored. The direct consequences are a lack of unanimous and consistent political support throughout the various European Member States, directly impacting new research initiatives, and market opportunities.

There is no doubt that, as with all technologies and human endeavors, genetic modification carries the potential for risk, therefore safety assessments are required to be performed for every new trait, within the context of a sound international broadly harmonized legislative framework. However, while the aim of regulatory systems is the same (protection of human health and the environment), innovation has continued to flourish under some (e.g., the US, Canada, Japan, and China) but not under others (e.g., Europe).

If Europe is to remain a leader in this crucial area of innovation, the concerns of both critics and advocates need to be critically addressed and then Europe should move on; expending time and energy constructing legislative and regulatory hurdles to counter biotechnology without valid justification is counterproductive. Used in conjunction with other methods, plant biotechnology can be a positive addition to the current agricultural portfolio.

Europe should therefore proceed responsibly in developing biotechnology, while taking all reasonable steps to minimize adverse effects. It is important to remember that, in some cases, not proceeding may be just as costly as moving ahead. This can be measured in negative impacts for each of the parameters essential for global sustainability, namely health, environment, and socio-economic development.

In the words of European Research Commissioner Philippe Busquin: "(…) It is time to reverse this downward trend. If we do not react, we will be dependent on technology developed elsewhere in the world within the next ten years."


EU View - 'Questions and Answers on the Regulation of GMOs in the European Union'

- European Commission, MEMO/06/58, 2006, Feb. 6, 2006. Excerpt below... Full document at

EU legislation on GMOs has been in place since the early 1990s. This specific legislation has two main objectives:
* to protect human health and the environment and
* to ensure the free movement of safe genetically modified products in the European Union.
The entire corpus of GMO legislation has recently been amended, leading to the creation of a new legal framework. Its main legal instruments are as follows:
* Directive 2001/18/EC on the deliberate release into the environment of GMOs applies to two types of activities:
* the experimental release of GMOs into the environment, i.e. the introduction of GMOs into the environment for experimental purposes (for example in connection with field tests);
* the placing on the market of GMOs, for example the cultivation, importation or transformation of GMOs into industrial products.
* The placing on the market of GMO food and feed or food and feed products containing or consisting of GMOs is regulated by Regulation (EC) No 1829/2003 on genetically modified food and feed. If one of the uses of a GMO concerns food or feed, the applicant may file a single notification for the GMO and all of its uses (cultivation, processing into industrial uses, food/feed use) under this Regulation, in accordance with the 'one door, one key' principle.
* Regulation (EC) No 1946/2003 on transboundary movements of genetically modified organisms governs unintentional transboundary movements of GMOs as well as exports of GMOs to third countries.
* Directive 90/219/EEC, as amended by Directive 98/81/EC, on the contained use of genetically modified microorganisms (GMMs). This Directive regulates research and industrial work activities involving GMMs (such as genetically modified viruses or bacteria) under conditions of containment, i.e. in a closed environment in which contact with the population and the environment is avoided. This includes work activities in laboratories.
* Labelling and traceability requirements are laid down in Regulation (EC) No 1829/2003 and Regulation (EC) No 1830/2003 concerning the traceability and labelling of genetically modified organisms and the traceability of food and feed products produced from genetically modified organisms and amending Directive 2001/18/EC.

A considerable number of implementing measures to support operation of this framework have also been adopted over the past years. These include, amongst other, guidelines for risk assessment, monitoring, formats for submissions of notifications, sampling and detection.
Release into the environment

The release of a GMO into the environment means an introduction of the GMO into the environment, without any precise confinement measure being taken to restrict the contact between this GMO and the population or the environment in general. Such a release may be carried out for experimental purposes or in connection with the placing on the market of a GMO.

Experimental releases of GMOs into the environment are mainly carried out for the purposes of study, research, demonstration and development of novel varieties. The behaviour of the GMO in an open environment and its interactions with other organisms and the environment are studied. The experimental releases are subject to the provisions of Part B of Directive 2001/18/EC.

If the results of the experimental release are positive, the company may decide to place the GMO on the market, i.e. make it available to third parties either free of charge or for a fee. The GMO may be placed on the market for purposes of cultivation, importation, or transformation into different products. The placing on the market of a GMO is mainly governed by the provisions of Part C of Directive 2001/18/EC.

What are the principles introduced by Directive 2001/18/EC?
Directive 2001/18/EC introduces:
* principles for environmental risk assessment (see below);
* mandatory post-market monitoring requirements, including on long-term effects associated with the interaction with other GMOs and the environment;
* mandatory information to the public;
* a requirement for Member States to ensure labelling and traceability at all stages of the placing on the market, a Community system for which is provided for by Regulation 1830/2003 on traceability (see below);
* information to allow the identification and detection of GMOs to facilitate post-market inspection and control;
* first approvals for the release of GMOs to be limited to a maximum of ten years;
* the consultation of the Scientific Committee(s)/European Food Safety Authority (EFSA) to be obligatory;
* an obligation to inform the European Parliament on decisions to authorise the release of GMOs and
* the possibility for the Council of Ministers to adopt or reject a Commission proposal for authorisation of a GMO by qualified majority.

More of this and links to support documents at http://europa.eu.int/rapid/pressReleasesAction.do?reference=MEMO/06/58&format=HTML&aged=0&language=EN&guiLanguage=en


Blast from the past...

'Time for the GM Moratorium To Go'

- Gregory Conko and C.S. Prakash, The Wall Street Journal Europe. May 13, 2003

After months of anticipation, the U.S. government is expected to file a formal complaint today with the World Trade Organization against the European Union's five-year moratorium on new genetically modified crop varieties. The move will undoubtedly be ridiculed as a cynical attempt by Americans to force GM products down the throats of skeptical Europeans.

Yet, while the U.S. is surely motivated by a parochial desire to aid American farmers, filing such a complaint will have benefits far beyond U.S. borders. The biggest beneficiaries are sure to be resource-poor farmers in less developed countries.

By now, many readers will be familiar with the story of Zambian President Levy Mwanawasa who, last autumn, rejected some 23,000 metric tons of food aid in the midst of a two-year-long drought that threatened the lives of over two million Zambians. President Mwanawasa's public explanation was that the GM maize from the United States was "poison." But, other Zambian government officials conceded that the bigger concern was for future corn exports to the EU market. If even a little of the food aid were diverted to seed stock, it could threaten the exportability of the entire Zambian maize crop for many years to come.

Zambia is not unique. European GM restrictions have had other, similar, consequences throughout the developing world. Thai government officials have been warned by European importers not to authorize any GM rice varieties. Uganda has stopped research on GM bananas and postponed their introduction indefinitely. Argentina has limited its approvals to two GM crop varieties that are already permitted in European markets. Even China, which has spent hundreds of millions of euros funding advanced biotechnology research, has refused to authorize any new GM food crops since the moratorium began.

Critics often deride GM crops with built-in pest, weed, and disease resistance as helpful only for wealthy farmers in industrialized nations, but developing countries could benefit tremendously from the adoption of GM crops. As much as 40% of conventional crop productivity in Africa and Asia is lost to insect pests, weeds, and plant diseases. But many of the same GM crops available in North America are already helping poor farmers in South Africa, India, China, and the Philippines combat often-voracious insects while reducing the amount of insecticides or eliminating them altogether. Indeed, studies of South African and Chinese cotton growers suggest that small farmers actually achieve disproportionately higher benefits from GM relative to larger competitors, because expensive machinery can at times be made obsolete.

What's more, GM crops with added nutritional benefits -- such as the much-touted golden rice and high-protein sweet potatoes -- are likely to be available within a few years.

Still, the EU moratorium persists after five long years despite copious evidence that genetic modification does not pose any risks that aren't also present in other crop-breeding methods. A review of 81 separate research projects conducted over 15 years and funded exclusively by the EU found that

GM crops and foods are just as safe for the environment and for human consumption as conventional crops, and in some cases are even safer because the genetic changes in the plants are much more precise.

Dozens of scientific organizations, including the U.N.'s Food and Agriculture Organization and the World Health Organization, have studied GM techniques and given them a clean bill of health. And in December, the French Academies of Medicine and Science added their names to that growing list and called for an end to the moratorium.

Some will claim that the EU is already set to end the moratorium just as soon as its new approval regulations and labeling and traceability rules are implemented by member nations. Why risk a consumer backlash at a time when the moratorium's end is within sight? But this naive assertion overlooks four important facts.

First, several EU members have already missed the first deadline for implementing the new GM rules, and debates still rage over the coexistence of GM, conventional, and organic crops. How close are they really to ending the moratorium?

Second, even if implementation is ultimately completed, what is to prevent individual members from ignoring the EU-wide rules? The European Commission has been famously impotent in pressing Austria, Luxembourg, and Italy to accept GM products that have already been approved by the EU.

Third, the new GM labeling and traceability rules are hardly an improvement on the current situation. Industrialized countries like the United States, Canada, and Australia may be able to comply. But for poor developing countries, the added cost and complexity of the labeling and traceability rules would only replace a de jure ban with a de facto one, shutting them out of the GM revolution for good.

Fourth, special regulations based solely on the process used in a product's creation are just as illegal as a ban under the terms of international treaties signed and ratified by the EU. So, the new GM rules don't even serve to bring the EU into WTO compliance. Nor are they needed, since voluntarily labeled non-GM foods can be found in almost every shop in Western Europe, giving consumers choice.

Interestingly, studies of consumer behavior show that, where labeled GM foods and labeled non-GM foods are available, even most European consumers seem to be indifferent to the "genetic status" of the goods they purchase. Indeed, the best possible scenario for all involved would be to end the moratorium immediately and genuinely expand consumers' ability to choose.

The EU's blatant flaunting of scientific assessments is why a WTO challenge is likely to succeed. And the fact that less developed countries are most likely to benefit is why the United States should file it. A decision by the 140-member World Trade Organization would send an important signal from the international community that the EU's groundless and genuinely harmful biotechnology restrictions must go.