Gm Food Crops example essay topic

1. HISTORICAL BACKGROUND LEADING TO DEVELOPMENT 1.1 Introduction On July 2, 2003, official agreements were finally made by the European Parliament with regards to new regulations on genetically modified food (GM). Consumer organizations and green groups are content with these results, as the voices of consumers are being heard over corporate interests. The United States accounts for two-thirds of bioengineer ed crops produced globally. Other major suppliers include Argentina, Canada, and China. More than twenty percent of the global crop areas of soybeans, corn, cotton, and canola acres are now biotech varieties.

On top of this, biotech ingredients and biotech processes are used in producing a wide selection of food and beverage products, such as meat, poultry, cheese, milk, and beer. The problem with this decision is that it would make selling in the European Union even harder than it already has been, as well as the fact that this move may widen the transatlantic gap, thus effecting trade relations between the European Union and the United States. 1.2 What exactly is a GM? These questions and answers have been prepared by WHO in response to questions and concerns by a number of WHO Member State Governments with regard to the nature and safety of genetically modified food.

Genetically modified organisms (GMOs) can be defined as organisms in which the genetic material (DNA) has been altered in a way that does not occur naturally. The technology is often called "modern biotechnology" or "gene technology", sometimes also "recombinant DNA technology" or "genetic engineering". It allows selected individual genes to be transferred from one organism into another, also between non-related species. 1.3 History In 1996, the United States was the first nation to export genetically modified food in Europe. It was tomato puree from California and it was voluntarily labeled as genetically engineered.

The product was a big hit with consumers in Britain because it was less expensive than conventional tomato puree. That same year, however, Greenpeace, and other environmental groups had a hostile response when GM soybeans were imported into Europe. By 1997, the European Union felt it would be best if they established mandatory labeling for GM foods. Yet from the viewpoint of the U.S. government, the European mandatory labeling policy was perceived as a trade barrier, and this is how the agricultural trade dispute between the European Union and United States began, which is still going on today. 1.4 GM Foods, Mad Cow Disease and Europe's response In 1996, then U.S. Agriculture Secretary Dan Glickman got an early glimpse of the unfolding controversy over GM foods when protesters at the World Food Summit in Rome bombarded him with grain, calling for a ban on GM crops. Several food crises have made consumers in Europe, particularly in the UK, awfully suspicious of changes to the food supply and skeptical of government regulatory.

Although these crises have not been caused by GM food, genetically modified foods have been bogged down with the concern about food safety". Mad cow disease", also known as bovine spongiform (BSE), which occurred in the 1990's, is the most significant of these food crises which started in the U. K, before spreading to the rest of Europe. BSE is an infectious degenerative brain disease in cows. The effects included the crippling of the British beef market. Throughout Europe, fears about mad cow disease and pictures of thousands of sick cattle being incinerated conquered television news, particularly when BSE was discovered in other European countries. In 1996, some governmental authorities, such as those in Britain, robustly approved agricultural biotechnology when foods derived from GM crops were beginning to be introduced to the European market.

The European press gave coverage to environmental and consumer groups and scientific critics who warned about unknown food safety and environmental risks. The concerns quickly caught the attention of suspicious European consumers. In a public opinion survey, the two institutions most likely to be trusted to "tell the truth" about biotechnology, after medical (54%), are consumer organizations (49%) and environmental organizations (46%). 1.4. 1 EU Opinion The historical and cultural context in which Europeans view food also helps to explain the concern about food safety and a distrust of food-safety regulators. Historically, Europeans seem to have a deeper cultural connection to their food than do Americans, for example. "The French connection, between food and pleasure - has been shaken in the last handful of years by mad cow disease, by diseased Belgian chickens, and now by growing anxiety about genetically modified foods, a stick point in trade negotiations between the United States and the European Union", wrote columnist Ellen Goodman.

Biotechnology, especially taking genes from one species and putting them into another, is seen by some as "unnatural" or unethical. For example, Britain's Prince Charles has stated that the development of genetically altered foods "takes mankind into realms that belong to God, and to God alone". To many Europeans, GM crops produced to date may be useful for farmers but have no direct consumer benefit, such as added nutritional value or improved taste. "Until now, in a context of food surplus, GM food has no added value, so why take the risk, the EU consumer is ask noting", said Tony Van der hagen, Minister-Counselor for Agriculture, Fisheries and Consumer Affairs of the European Commission. During the period between 1990 and 1998, fourteen GM crops had been approved by the EU for release onto the commercial market. An additional thirteen applications for approval had received favorable opinion of the Scientific Committee on Plants and were pending authorization.

In the late 1990's, opposition to GM foods moved quickly to the forefront of political debate in Europe. Representation of the Green Party in a number of European parliaments and cabinets, as well as changes that gave increased power to the evolving European system were major contributors to this development. The growing number of consumer and environmental groups was also influential and should be considered a contributing factor. 1.4. 2 Resistance to GM foods In 1997, Austria and Luxembourg banned several GM crops approved by the EU. Theoretically, nations could not ban crops already approved under the EU command, but the EU took no legal action to force agreement. Over the next several years, additional bans on EU-approved crops followed in Austria, Italy, Greece and Germany.

In 1998, a number of EU nations, led by France, vowed to block approval of GM crops unless existing labeling and safety regulations were further tightened. As a result, since 1998, no new GM crops have been approved in Europe, resulting in a de facto moratorium. Despite widespread consumer resistance to GM foods, four European nations: Spain, Portugal, France, and Germany, continued to plant commercialized GM crops. Six member states: France, Italy, the U.K., Spain, the Netherlands, Belgium and Germany have carried out field trials of GM plants, although the number of field trials has dropped 76 percent since 1998. In addition, three of the ten eastern European nations that are slated to join the EU in 2004 have approved commercial cultivation and field trials of GM plants.

1.5 EU Labeling and Traceability Law Since 1997, EU regulations have required labeling for some GM food products. However, the new EU legislation expands the labeling requirements significantly and also requires "trace notability" - the ability to track a GM product from the farm through all of the distribution, processing, and manufacturing steps to the final consumer product. The new legislation also establishes a more streamlined, centralized authorization procedure for GM crops and GM food ingredients and their release in the environment and in the marketplace. The newly passed regulations on traceability and labeling will enter into force 90 days after publication in the Official Journal of the European Union, which is expected in October 2003. Member states must comply with the new food and feed approval process within six months of the date of publication. The Commission will review the regulations after two years.

Previous EU regulations required labeling of GM seeds, plants, and foods derived from GM plants, provided that the DNA or protein of GM origin was detectable in the final product. For example, while corn flour derived from GM maize would be labeled, corn fructose syrup processed from GM maize would not because it would be free from any GM DNA or proteins. Animal feed was not required to be labeled. Under the new EU legislation all foods with ingredients derived from GM crops will be required to be labeled, whether or not there were detectable levels of GM DNA or proteins. The accidental presence (up to 0.9%) of GM material in food would continue to be exempted from the labeling obligation. The new regulations also impose for the first time labeling requirements for GM animal feed along the same principles as for GM food.

Products required to be labeled would be need to state that "This product contains genetically modified " or that it has been "produced from genetically modified (name of organism)". The new legislation does not, however, require labeling of products such as meat, milk or eggs obtained from animals fed GM feed or treated with GM medicinal products. Products such as cheese or beer, which are often produced with the aid of enzymes produced by GM micro-organisms, also do not need to be labeled. The rationale for this distinction, according to European Commission officials, is that these products do not include GM ingredients, but rather are produced with GM processing aids that are not present in the final product. LABELING OF GM FOOD AND GM FEED AS PROPOSED BY THE EUROPEAN COMMISSION IN JULY 2001 GM Product Type Example Labeling required at present Labeling required if new regulations are adopted GM plant Chicory Yes YesGM seed Corn seeds Yes YesGM food Corn, Soybeans sprouts, tomato Yes Yes Food produced from plant or seed Corn flour Yes Yes Refined corn oil, Soybean oil, Rape seed oil No Yes Glucose syrup produced from corn starch No Yes Food from animals fed on GM feed Eggs, Meat, Milk No No Food produced with the help of a GM enzyme Bakery products produced with the help of amylase No No Food additive produced from GM plant or seed Highly filtered lecithin extracted from GM soybeans used in chocolate No Yes Animal GM feed Corn Yes Yes Animal feed produced from a GM plant or seed Corn gluten feed, Soybean meal No Yes Feed additive produced from a GM plant or seed Vitamin B 2 (riboflavin) No Yes DNA or protein of GM origin detectable in final product. DNA or protein of GM origin not detectable in final product.

SOURCE: European Commission The new EU legislation also requires businesses that grow, store, transport, or process GM to track them throughout the commercial food chain, from "farm to fork". Under these rules, industry will need to ensure that systems are in place to identify to whom and from whom GM products are made available and to retain records for five years. All foods would require documentation demonstrating whether they contained ingredients derived from GM crops, even if the presence of GM-derived material could not be detected in the final product. 1.6 GM Approval Process The responsibility for evaluating and authorizing GM crops and foods containing GM ingredients was divided among EU member states and the European Commission. Under the new regulations, a "one door-one key" procedure is established. All scientific risk assessment is carried out by a single agency, the European Food Safety Authority.

This organization is also responsible for communicating risks to the public. Following the risk evaluation by the FSA, the Council of Ministers is responsible for making the decision to approve or reject a GM product for the EU market. Another change to the approval process affects products containing GM varieties that are not approved for release onto the market under 2001/18/EC, but have received a favorable opinion from the Scientific Committees. The Scientific Committees may issue a positive risk assessment for a GM variety that has not completed the approval process. These varieties may enter the EU market in products if the products contain less than 0.5 percent of the non-approved, but positively assessed variety. For varieties that have not received approval or positive risk assessments, there is a zero tolerance in any commercial product.

2. CHRONOLOGY OF EVENTS Timeline of events relevant to U.S. -EU agricultural biotechnology trade issues 1990 - APRIL The EU adopts Directive 90/220/EC, which establishes a process for the approval of agricultural biotechnology products. 1994-1998 The EU authorizes the commercial use of nine GM products and plants. 1995 - MAY The U.S. approves the first commercially significant biotech soybean, Monsanto's "Round-up Ready". 1996 Crop varieties developed by biotechnology are first introduced for commercial production in the U.S. 1996 - MARCH 20 Scientific evidence reveals a link between some cases of a variant form of a brain wasting disease in humans and consumption of meat from cows with bovine spongiform encephalitis (BSE or "mad cow disease"). The British government downplays the link and argues that meat is safe to eat.

1997 - FEBRUARY Austria bans Novartis Bt 176, a GM maize that has already been approved for use in the EU. The Commission does not challenge the action. Luxembourg also bans an EU-approved maize variety this year. 1997 - MAY 15 The EU adopts the "Novel Foods Regulation", which requires that the person responsible for placing a novel food, including any food containing or produced from GM crops, on the market shall submit a request to the Member State in which the product will first be mar-ke ted.

Relevant authorities in that Member State then decide either to allow the product on the market or to refer the application to the European Commission. In either case, the other Member States have an opportunity to make their views known. The regulation also provides for special labeling of foods containing GM ingredients, provided that the GM content can be detected. The Novel Food Regulation included several exemptions for products that did not need to be labeled. It also did not define a standard for the percentage of a product that could contain GM ingredients before it had to carry the GM label.

1997 - SEPTEMBER 19 EU regulation provides for labeling of foods processed from certain Bacillus (Bt) corn, or corn that has been genetically engineered to produce its own insecticide, and he rbi-code-tolerant soybeans. These products were already on the market when the May 1997 novel foods labeling directive went into effect. 1998 France bans two EU-approved rapeseed varieties; Greece bans one EU-approved rapeseed variety. 1998 - OCTOBER Approval of new agricultural biotechnology products in the EU comes to a halt. The EU Commission tells the U.S. that they will begin to approve products again if the companies submitting applications agree to follow newly proposed revisions before they become law. Despite applicant compliance, the EU approval processes does not resume.

1999 Austria bans two more EU-approved maize varieties. 1999 - JUNE EU members call for a moratorium on new approvals of GM products. The EU Environmental Council says traceability and labeling must be linked with a new approval process. Ministers from Denmark, France, Greece, Italy, and Luxembourg declare a refusal to approve new prod-u cts until new rules are in place. 1999 - DECEMBER The Ministerial Conference of the World Trade Organization (WTO) in Seattle is disrupted by demonstrations by people concerned about continued globalization of trade, as well as issues of agriculture and trade in GM foods. The U.S. and Canada propose a working group on bio-technology.

2000 Italy bans four EU-approved maize varieties; Germany bans one EU-approved maize variety. 2000 - JANUARY 11 The European Commission publishes a regulation providing a one percent labeling threshold for food for accidental commingling of corn and soy made by modern biotechnology. It is expected that the threshold will be adopted as the basis for labeling other foods containing ingredients made from biotechnology. 2000 - JANUARY 29 More than 130 countries adopt the Cartagena Protocol on Biosafety, aimed at providing a framework for assessing the environmental impact of bioengineer ed products that cross inter-national borders. Fifty countries must ratify it before it goes into effect. The scope of the pro-to col does not cover food safety.

2000 - MARCH The Codex Ad Hoc Task Force on Foods Derived from Biotechnology has their first meeting in Japan. 2000 - APRIL The Food Standards Agency (FSA) is created in the EU to "protect public heath from risks which may arise in connection with the consumption of food, and otherwise to protect the interests of consumers in relation to food". This includes responsibility for issues relating to GM foods. 2000 - JUNE French Environmental Minister Dominique Voy net, speaking for the five states who voted for a moratorium on GMOs, insists on the inclusion of a liability scheme for biotechnology products.

2000 - JULY EU Environmental Ministers met informally and decided to support the moratorium at least until the Commission prepares labeling and traceability proposals for biotech products. The Commission tells the U.S. that it will complete the proposals by the end of the year so that the approval process could start up again. 2000 - SEPTEMBER Star Link (R) corn - a GM corn variety approved only for animal consumption-is found in taco shells sold in the U.S. 2001 - JANUARY 17 The U.S. Food and Drug Administration (FDA) issued a proposed rule and a "Guidance for Industry" document for labeling GM products. The proposed rule would require food develop-ers to notify FDA at least four months before putting a new GM food on the market, and the scientific description of the product is posted on the Internet during this time. The guidance on labeling was meant for manufacturers who wish to voluntarily label their foods as being made with or without the use of GM ingredients.

2001 - JUNE At the G-8 Economic Summit in Italy, the U.S. -EU Summit includes a special session of World Trade Organization (WTO) agriculture negotiations. 2001 - JULY 25 The European Commission proposes legislation amending Directive 2001/18/EC on labeling and traceability and assures the U.S. that the moratorium will be lifted within weeks. 2001 - OCTOBER At an informal meeting of the Environmental Ministers Council, France, Austria, Finland, Luxembourg, Denmark, Italy, the Netherlands, and Sweden all reject the Commission's plan to restart the GMO approval process, and declare the new regulations must be in force before the process should be allowed to operate. 2002 The European Food Safety Authority will become operational and will be responsible for risk assessment and risk communication with the public. 2002 - MARCH 21 The Economic and Social Committee issues its opinion on the Commission's 2001 proposal on labeling and traceability.

2002 - MAY 16 The Committee of the Regions issues its opinion on the Commission's 2001 proposal on label-ing and traceability. 2002 - JUNE 3 The Environment Committee of the European Parliament narrowly voted to require all food products derived from biotech ingredients be labeled - even if no remnants of the genetic modification (DNA) are detectable in the final product on the shelves. In addition, the Committee approved a measure to lower the threshold at which mandatory labeling would be required, lowering it from one percent in the original EC proposal to 0.5 percent per ingredient. 2002 - AUGUST 27 The European Union ratifies the Cartagena Protocol on Biosafety. 2002 - SUMMER Mid-term report of the Codex Ad Hoc Task Force on Foods Derived from Biotechnology is made to the Codex Executive Committee. 2002 - SEPTEMBER 15 The European Commission resubmits a revised proposal to amend Directive 2001/18/EC based on the amendments requested by the Parliament's first reading in June 2002.2002 - OCTOBER 17 Directive 2001/18/EC is implemented and Directive 90/220/EEC is repealed.

This implement a-ti on requires that the 15 Member States have all implemented national legislation that adopt Directive 2001/18/EC, and have notified the Commission of their action. Twelve of the 15 Member States fail to meet this deadline do not adopt implementing measures on a national level, continuing to ban new GM products. 2002 - DECEMBER The Council of Ministers on the Environment agrees to a common position on traceability and labeling. The Danish delegation declares the moratorium should remain in place until the EU has developed and implemented liability legislation for biotech products.

2003 - MARCH 11-14 The Codex Ad Hoc Task Force on Foods Derived From Biotechnology meets in Yokohama, Japan. 2003 - MARCH 17 The EU Council of Ministers concludes a Common Position on the Commission's September 2002 amendments to its 2001 proposal. The Common Position is forwarded to the European Parliament. 2003 - APRIL 10 The European Commission formally requests action to be taken in France, Luxembourg, Belgium, Netherlands, Germany, Italy, Ireland, Greece, Spain, Portugal, and Austria to adopt and notify the Commission of national legislation that implemented Directive 2001/18/EC.

2003 - MAY 15 The U.S. files a complaint to the WTO to dispute the EU moratorium on GM imports. 2003 - MAY 20 United States' President Bush accuses the EU of impeding the fight against famine in Africa, calling the ban on GM foods morally wrong and based on "unscientific fears". EU Commissioner on Trade Pascal Lamy answers back that the accusations are "unacceptable" and "should not be used in this kind of debate". 2003 - JUNE 13 Palau becomes the 50th country to ratify the Cartagena Protocol on Biosafety, effectively setting the Protocol to take effect in September 2003.2003 - JUNE 19 The United States and EU begin consultation in regards to the WTO suit brought by the U.S. The consultations broke down shortly after they began with no solution. The U.S. delegation announces their intent to ask for the empanelment of a WTO Dispute Settlement Body. 2003 - JUNE 30-JULY 7 The 26th Session of the Codex Alimentarius Commission, meets in Rome, Italy.

The Draft Guideline for the Conduct of Food Safety Assessment of Foods Produced Using Recombinant-DNA Microorganisms from the Ad Hoc Committee on Foods Derived from Biotechnology is considered. 2003 - JULY 2 The European Parliament passes the Commission's September version of the proposed amendments to Directive 2001/18/EC. The United States does not accept the action as "lifting the moratorium" and vows to continue its push for more favorable laws for its GM products. 2003 - JULY 15 The European Commission refers Austria, Belgium, Finland, France, Germany, Greece, Ireland, Italy, Luxembourg, Netherlands and Spain to the European Court of Justice for failing to adopt and notify national legislation implementing Directive 2001/18/EC. 2003 - JULY 22 The Council of Ministers consents to the Commission's amendments to Directive 2001/18/EC on labeling and traceability.

2003 - JULY 23 The European Commission issues guidelines for the agricultural management of "co-existence" or producing GM crops next to non-GM crop varieties. 2003 - SEPTEMBER 10 Europe's top court said Italy and other governments can block the sale of genetically modified food in Europe, but have to come up with better reasons. 2004 - APRIL 18 European countries start enforcing the world's strictest rules on labeling GM foods. 2004 - SEPTEMBER 8 European commission does not agree on new rule that would have allowed a batch of 1000 conventional seeds containing 3 or less GM seeds to be sold without letting the food manufacturers and consumers know it contained GM ingredients. 3. ANALYSIS This transatlantic agricultural trade dispute has extended to many other countries.

Now, governments around the world are developing GM labeling requirements, but are finding themselves trapped between the U.S. and the EU approaches. Consumers are confused about what exactly GM foods are and whether these foods are harmful or safe. Scientists have concluded that pre-commercialization assessment procedures of bioengineer ed food guarantee the GM food is nutritionally equivalent and as safe as conventional food (e.g. the World Health Organization, 2000). However, in Europe consumers do not necessarily trust scientists, particularly after they were informed in the mid 1990's that humans could not get mad cow disease.

The GM labeling issue is not only about science. To be more precise, the politicians and environmental groups in Europe and in other places express GM labeling is about consumer choice and consumer rights, and is not about the health issue. The Europeans are just taking a precautionary approach. On the other hand, the United States, Canada and Japan are using science-based risk assessment procedures. 3.1 The European Commission's Rationale According to the European Commission, more extensive labeling information is meant to help restore consumer confidence in the food regulatory system, to provide consumers with greater choice about what they eat, and build consumer confidence in GM products. The objectives for requiring traceability of GM products are to facilitate the withdrawal of a product in the event of an unforeseen risk to human health or the environment, to aid in the monitoring for potential health or environmental effects, and to control and verify labeling claims.

The new risk assessment and approval process is intended to streamline the approval process and end the de facto moratorium on new GM crop approvals. Commenting on the new rules, EU Environment Commissioner, Margot Wallstr " om, said that the new rules "address the most critical concerns of the public regarding health and environmental effects of GMOs and enable consumers to choose". EU Health and Consumer Protection Commissioner, David Byrne, said that the new system gives the EU "the most rigorous pre-marketing assessment of GM food and feed in the world" that "should give consumers greater confidence". Explaining the rationale in more detail when the proposals were first made in 2001, Tony Van der hagen, Minister-Counselor for Agriculture, Fisheries and Consumer Affairs of the European Commission: "Unless we restore EU consumer confidence in this new technology, genetic modification of food is dead in Europe. The Commission's... labeling and traceability proposal is intended to be a first step to increase that confidence... Although genetically modified foods may even be safer than conventional products, our consumers are nevertheless demanding that we in government protect their 'right to know' the content and origin of the food they consume".

3.2 Why are GM foods produced? GM foods are developed - and marketed - because there is some perceived advantage either to the producer or consumer of these foods. This is meant to translate into a product with a lower price, greater benefit (in terms of durability or nutritional value) or both. Initially GM seed developers wanted their products to be accepted by producers so have concentrated on innovations that farmers (and the food industry more generally) would appreciate. The initial objective for developing plants based on GM organisms was to improve crop protection. The GM crops currently on the market are mainly aimed at an increased level of crop protection through then of resistance against plant diseases caused by insects or viruses or through increased tolerance towards herbicides.

Insect resistance is achieved by incorporating into the food plant the gene for toxin production from the bacterium Bacillus (BT). This toxin is currently used as a conventional insecticide in agriculture and is safe for human consumption. GM crops that permanently produce this toxin have been shown to require lower quantities of insecticides in specific situations, e.g. where pest pressure is high. Virus resistance is achieved through the introduction of a gene from certain viruses which cause disease in plants. Virus resistance makes plants less susceptible to diseases caused by such viruses, resulting in higher crop yields. Herbicide tolerance is achieved through the introduction of a gene from a bacterium conveying resistance to some herbicides.

In situations where weed pressure is high, the use of such crops has resulted in a reduction in the quantity of the herbicides used. Such methods are used to create GM plants - which are then used to grow GM food crops. 3.3 How are GM foods approved for safety? All genetically modified (GM) foods to be marketed in the EU are subjected to a rigorous safety assessment before being permitted to enter the food chain.

In the UK this can involve up to 60 independent scientists. The FSA will make public the results of these assessments, unless it is commercially confidential, so as to allow input into the evaluation process. The reports of the assessments are also made public. The Agency takes expert advice on the safety aspects of GM foods from the Advisory Committee on Novel Foods and Processes.

3.4 Trading GM foods internationally No precise international regulatory systems are presently in place, but several international organizations are involved in developing protocols for GMOs, such as, The Codex Alimentarius Commission (Codex). Codex is the joint FAO / WHO body responsible for compiling the standards, codes of practice, guidelines and recommendations that form the Codex Alimentarius: the international food code. Codex is developing principles for the human health risk analysis of GM foods. The basis of these principles orders a pre-market assessment, performed on a case-by-case basis and including an evaluation of both direct effects (from the inserted gene) and unintended effects (that may arise as a consequence of insertion of the new gene). Codex principles do not have a obligatory effect on national legislation, but are referred to specifically in the Sanitary and Phytosanitary Agreement of the World Trade Organization (SPS Agreement), and can be used as a reference in case of trade disputes.

The Cartagena Protocol on Biosafety (CPB) is an environmental treaty legally binding for its Parties that controls trans-boundary movements of living modified organisms (LMOs). GM foods are within the range of the Protocol only if they have LMOs that are able to transfer or replicate genetic material. The foundation of the CPB is a requirement that exporters seek approval from importers before the first shipment of LMOs intended for release into the environment. The Protocol was entered in 2003.3.

5 The affect on the marketing of GM foods in the European Union The public concerns about GM food and GMOs in general have had a major impact on the marketing of GM products in the European Union. Actually, they have resulted in the moratorium on approval of GM products to be placed on the market. Marketing of GM food and GMOs in general are the focus of extensive legislation. Community legislation has been in place since the early 1990's.

The procedure for approval of the release of GMOs into the environment is rather difficult and essentially needs agreement between the Member States and the European Commission. Between 1991 and 1998, the marketing of 18 GMOs was approved in the EU by a Commission decision. As of October 1998, no further authorizations have been granted and there are currently 12 applications pending. Some Member States have used a safeguard clause to temporarily ban the placing on the market in their country of GM maize and oilseed rape products. There are currently nine ongoing cases. Eight of these have been examined by the Scientific Committee on Plants and in all cases believed that the information given by Member States did not validate their bans.

During the 1990's, the regulatory framework was additionally extended and refined in response to the legitimate concerns of citizens, consumer organizations and economic operators. A revised directive came into force in October 2002. It updated and strengthened the existing rules pertaining to the process of risk assessment, risk management, and decision making in regards to the release of GMOs into the environment. The directive also foresees mandatory monitoring of long-term effects related with the interaction between GMOs and the environment.

Labeling in the EU is mandatory for products resulting from modern biotechnology or products including GM organisms. Legislation also addresses the problem of accidental contamination of conventional food by GM material. It introduces a. 9% minimum threshold for DNA or protein resulting from genetic modification, below which labeling is not required. In 2001, the European Commission adopted two new legislative proposals on GMOs concerning traceability, emphasizing existing labeling rules, and streamlining the authorization procedure for GMOs in food and feed and for their release into the environment. The European Commission is of the opinion that these new proposals, building on existing legislation, aim to address the concerns of Member States and to develop consumer confidence in the approval of GM products.

The Commission expects that adoption of these proposals will pave the way for resuming the authorization of new GM products in the EU. 3.6 International Approaches to GM Labeling Internationally, Codex has a Committee on Food Labeling. Since 1990, Codex has sought to form guidelines for labeling GM foods. However up until now, there has been a disagreement on the international standards. A final Codex standard on the labeling of GM foods will probably not occur for many years to come.

The table below shows the approaches taken in different countries towards GM food labeling. The EU has very strict GM labeling rules. The governments of the United States, Argentina, and Canada, which are also the three big producers of GM foods, do not believe in mandatory labeling. Japan, South Korea, China, and other countries are in the middle of the EU and the United States on this issue.

Sample of International Guidelines for Labeling GM Foods Labeling Scheme % Threshold for Unintended GM Material Are some biotech foods and processes exempt? Canada Voluntary 5%c N / United States Voluntary N / A N / Argentina Voluntary N / A N / A Australia & New Zealand Mandatory 1% Yes European Union Mandatory 0.9%a Yes Japan Mandatory 5%b YesS. Korea Mandatory 3%b Yes Indonesia Mandatory 5%c Yes Key: N / A means not applicable a. Proposed threshold in the EU, lowered from 1%. b. Top 3 ingredients in Japan and top 5 ingredients in S. Korea. c.

Not yet operational. Source: Personal interviews and various Attach'e Reports from the USDA Foreign Agricultural Service (web). The U.S. government's opinion for non-mandatory labeling is because of the scientific evidence provided by the FDA that GM foods are nutritionally equal to non-GM foods. As long as the food is safe from contamination, labeling is not required. A labeling debate does exist in the United States. Anti-biotech groups in Oregon put the GM labeling issue on the state's 2002 ballot-Measure 27.

If it had been approved, Measure 27 would have had required the labeling of any product having GM ingredients, or processed with GM material or biotechnology. In 2002, the EU's Parliament agreed to new GM labeling proposals. These new guidelines were debated and modified in the EU Commission and in the EU Council at the end of 2002. The EU regulations would require the labeling of foods whose ingredients contain 0.9% or more of GM DNA or protein.

The current tolerance level is 1%. The new EU regulations would require labeling of food and feed products containing even non-detectable GM material. Importantly, only approved GM material would be allowed in food and feed sold in the EU. Compared to the U.S. or Japan, only a small number of GM crops are authorized in the EU. Since they were implemented they jeopardized a large share of U.S. food exports to Europe. Partly in response to these new EU labeling proposals, the U.S. government filed a World Trade Organization (WTO) trade action against the EU for restraining trade.

The trade action deals with the EU moratorium on any new GM crops in Europe, in place since 1998, and the European labeling regulations. The costs of the labeling regulations in the EU are largely endured by U.S. exporters. The 0.9% tolerance level will be costly to implement for food processors. It seems excessively low for a label with no intended food safety purposes. Besides, the absence of labeled GM products at the retail level makes this labeling policy a "political" moratorium.

Australia and New Zealand both adopted mandatory labeling with a 1% threshold for the unintentional presence of GM product, but vegetable oils, food additives, and food processing aids, such as enzymes used in cheese and brewing, are exempt from labeling requirements. Japan's labeling regulations are much more rational than those in the EU. The Japanese government requires mandatory labeling when GM material is present in the top three raw ingredients and accounts for 5% or more of the total weight. It also admits the presence of non-GM labels at the same tolerance level, if produced with identity preservation.

So tofu can be made from non-GM soybeans and be labeled as such or else it must be labeled as containing GM material. Exemptions to Japan's labeling requirements include feedstuffs, alcoholic beverages, and processed foods such as soy a sauce, corn flakes, and other vegetable oils. South Korea's regulations are similar to Japan's except the tolerance level is 3% of the top 5 ingredients. In the EU, the threshold applies to each ingredient. China leads the world in public biotech crop research. GM crops in the field trial stage include rice, wheat, corn, soybeans, potatoes, cabbage, and tobacco.

GM cotton accounts for about 30% of China's cotton acreage. China has not yet declared a definite position on GM labeling, but it has proposed restrictions on GM crop imports. Outside China, this is viewed as a trade barrier that limits soybean imports from the United States. China's stance towards biotechnology in agriculture appears to be greatly influenced by EU policy. Overall, the mandatory GM food labeling affects international trade and marketing.

The European policy affects the choices of other agricultural exporting countries. Also, the mandatory labels saying this product contains genetically modified ingredients will be perceived as a warning sign to consumers. This could lead to a complete ban of GM products. 4. IMPACT ON VARIOUS STAKEHOLDERS 4.1 Benefits and Controversies of GM Foods Benefits Crops - Enhanced taste and quality Reduced maturation time Increased nutrients, yields, and stress tolerance Improved resistance to disease, pests, and herbicides New products and growing techniques Animals - Increased resistance, productivity, hardiness, and feed efficiency Better yields of meat, eggs, and milk Improved animal health and diagnostic methods Environment - 'Friendly' bio herbicides and bio insecticides Conservation of soil, water, and energy Bio processing for forestry products Better natural waste management More efficient processing Society -Increased food security for growing populations Controversies Safety - Potential human health impact: allergens, transfer of antibiotic resistance markers, unknown effects Potential environmental impact: unintended transfer of trans genes through cross-pollination, unknown effects on other organisms (e. g., soil microbes), and loss of flora and fauna biodiversity Access and Intellectual Property - Domination of world food production by a few companies Increasing dependence on Industrialized nations by developing countries Bio piracy-foreign exploitation of natural resources Ethics - Violation of natural organisms' intrinsic values Tampering with nature by mixing genes among species Objections to consuming animal genes in plants and vice versa Stress for animal Labeling - Not mandatory in some countries (e. g., United States) Mixing GM crops with non-GM confounds labeling attempts Society - New advances may be skewed to interests of rich countries 4.2 U.S. Reaction to the EU Response to GM Foods Since 1998, U.S. farm organizations and biotechnology companies have objected to the de facto moratorium on new GM crop approvals, as well as the refusal of some EU member states to allow GM crops that had already been approved by the EU. United States government officials in both the Clinton and Bush administrations raised objections; the EU responded that it was working to put new acceptable rules in place.

In May, 2003, the U.S. along with several other nations launched a formal complaint process under the World Trade Organization's dispute settlement mechanism, arguing that the de facto moratorium is not in compliance with WTO agreements. (The U.S. led complaint did not include the new labeling and traceability requirements, which had not yet gone into effect.) Under WTO rules, if a member does not comply with WTO recommendations then trade sanctions may follow. Some have questioned the ultimate effect of the WTO complaint, noting that the action is likely to generate additional hostility to GM foods in Europe and that the EU may be more likely to incur trade sanctions than change its policy. The European hostility towards a WTO case over GM products is reminiscent of the WTO case brought against the EU by the U.S. over the EU's refusal to buy beef raised with bovine growth hormone. Instead of allowing the beef into the EU market as instructed by the WTO dispute settlement body, the EU chose not to conform to the decision and to instead to face retaliatory measures in the forms of increased tariffs on other EU goods exported to the U.S. In a press conference in response to the filing of the U.S. complaint, EU Commissioner Wallstr " om said that the "U.S. move is unhelpful. It can only make a difficult debate in Europe more difficult.

But in the meantime, the Commission strongly believes that we in Europe should move ahead with completing our legislation on traceability and labeling on food and feed, currently before the European Parliament. We should not be deflected or distracted from pursuing the right policy for the EU". U.S. farm and industry officials have strongly expressed the view that the EU de facto moratorium is an illegal restraint on trade because it is a violation of the EU's own trade rules and procedures. In addition, they believe that GM crops and foods are as safe as conventional foods and that there is no scientific basis for health or safety restrictions. U.S. officials believe that a challenge is necessary to discourage other countries, especially those in the developing world, from using the EU regulatory approach as the basis for their own regulations on agricultural biotechnology products, which could result in even wider-scale disruptions of U.S. trade. President Bush recently re-iterated his Administration's concern that stringent EU restrictions have led to the refusal of several south African nations to accept U.S. food aid that included GM corn, further exacerbating famine.

4.3 U.S. RESPONSE TO NEW EU LABELING AND TRACEABILITY REGULATIONS U.S. government officials, farm groups, biotechnology companies, and food processors and manufacturers have also expressed deep concern over the impacts of the new EU labeling and traceability requirements. They regard the EU rules as costly, unworkable, unenforceable, unnecessary and discriminatory against U.S. agricultural products. David Heywood, Trade Advisor to U.S. Department of Agriculture Secretary Ann Venema n, said when the rules were first proposed that they would "disrupt international trade without serving any legitimate food safety or environmental safety objectives". U.S. farmers and biotechnology companies are particularly concerned about the potential impact of the new rules on exports of GM crops such as soybeans that, to date, have not been directly affected by the de facto moratorium. The new rules will result in labels on soybean products, such as animal feeds and refined soybean oil that previously have not been labeled as containing GM components. Producers are concerned that GM-wary consumers in Europe will avoid foods and feeds labeled as containing GM ingredients. Avoiding the GM label will, however, be costly.

The U.S. commodity grain system routinely mixes in GM varieties with conventional varieties of corn and soybeans. To avoid the EU threshold for labeling, U.S. farmers and food producers would have to segregate GM crops and foods derived from such crops at every step of the crop harvesting and food production processes - a requirement that experts say would undermine the efficiency and competitiveness of existing commodity grain production systems. In any event, many industry experts believe that getting the level of GM content down to no more than 0.9 percent would be difficult, if not impossible to achieve. Even if different varieties of crops are kept separate, some unintentional mixing of GM grains with non-GM grains is likely to occur.

For example, pollen drift is a natural occurrence that can lead to the unintended presence of GM material in non-GM crops. Difficulty in segregating GM content also makes it difficult to accurately label all GM food products with such labels - especially. The likely result is that many U.S. crops exported to Europe, and processed goods made from them such as cooking oils, would be required to have a label indicating the final product contains GM ingredients. U.S. officials, farm groups, and biotechnology companies are concerned that EU consumers simply won't buy products if alternatives exist. If such a scenario were to unfold, trade officials at the U.S. State Department believe, the U.S. stands to lose as much as $4 billion in annual agricultural exports to the EU. The Bush Administration believes that the EU labeling regime is both unnecessary and discriminatory. U.S. producers argue that there is no scientific basis to presuppose that GM food products are more risky or substantially different from other products and that decisions to label foods should be based on science, not politics. Furthermore, labels that identify foods as derived from biotechnology are likely to be seen by consumers as "warning labels", which would decrease the demand for these products. U.S. officials point out that the EU rules do not require labeling of products like beer and cheese (major European agricultural exports) that are made using enzymes produced with biotechnology, while soy oil derived from GM soybeans would have to be labeled even if no GM protein could be detected. U.S. officials have also expressed concern about the cost and need for the traceability requirements, which will require businesses throughout the food chain to track incoming and outgoing products and to retain paperwork to show a "chain of custody" from farm to fork. U.S. farm groups and others are pushing for the U.S. to initiate a challenge to the EU labeling and traceability requirements.

Ron Gas kill, from the American Farm Bureau Federation, said that the labeling and traceability rules are "just as inconsistent with the WTO agreement on technical barriers to trade and sanitary and measures as the moratorium itself is". 4.4 Impact on Poor Countries The strict European regulations are delaying the introduction of GM crops in poor countries, such as the vitamin A enriched rice (the so-called golden rice). Cotton remains the only GM crop planted in South Africa or India because GM cotton does not have labeling requirements anywhere. Zambia's refusal of GM corn as food aid in the face of massive starvation caught the world's attention and resulted in criticism of the EU.

4.5 Impact on U.S. Exports The most important field crops grown in the U.S. are corn, cotton, and soybeans in terms of volume and farm income. They are necessary in the production of human food and animal feed. They are also the source of many ingredients used widely in processed foods, for example in high corn syrup and lecithin. These three crops are also major U.S. commodity exports. In the United States, large percentages of these crops are also genetically modified.

In 2003, about 81 percent of the soybeans, 73 percent of the cotton, and 40 percent of the corn grown in the U.S. was genetically engineered. The U.S. accounts for two-thirds of all GM crops in the world now being planted in the U.S. Since bulk export shipments usually mixed corn from many farms, including those growing genetically modified varieties not approved by the EU, U.S. corn exports to Europe fell dramatically. Before 1997, the U.S. sold about 1.75 million tons of corn annually to Spain and Portugal, the two largest importers of U.S. corn in the EU. In the 1998-1999 crop year though, Spain bought less than a tenth of the previous year's amount and Portugal bought none at all. The American Farm Bureau Federation estimates that U.S. exporters have lost about $300 million per year. The decline in U.S. corn exports to Europe has been dramatic, but Europe accounted for only about 4 percent of the total U.S. corn export market in 1998 and has fallen to less than 0.1 percent in 2002.

However, Europe is the most important U.S. export market for corn byproducts, such as the corn gluten used in animal feed, accounting for more than 46 percent of total exports. The trade of corn byproducts so far has not been affected by EU regulations on GM products, but may be greatly affected in the future by the new approval process and stringent for accidental presence, traceability, and labeling being enforced. In contrast to GM corn, GM soybean exports to the EU have not been affected by the de facto moratorium. The EU had approved one variety of GM soybean prior to 1998, and American soybean producers have generally cultivated only that approved variety. American soybean producers have been hesitant to introduce new biotech varieties that have not been approved for the European market because EU accounts for a significant proportion (21% in 2002) of U.S. soybean exports. While U.S. soybean exports to the EU have fallen (from 9.8 million tons in 1995 to 5.5 million tons in 2002), it is commonly believed that this decline has been due to competition from lower-cost agricultural producers such as Brazil, whose exports have risen from 3.0 million tons in 1995 to 8.9 million tons in 2002.

The European Commission attributes this fall in U.S. imports to a loss of competitiveness of the U.S. soybean on international markets, and not to the cultivation of GM soybeans. 4.6 Impact on human health The three main issues debated for GM affecting health are tendencies to incite allergic reaction (allergenicity), gene transfer, and out crossing. a. Allergenicity - the transfer of genes from commonly allergenic foods is discouraged unless it can be demonstrated that the protein product of the transferred gene is not allergenic. While traditionally developed foods are not generally tested for allergenicity, protocols for tests for GM foods have been evaluated by the Food and Agriculture Organization of the United Nations (FAO) and WHO. No allergic effects have been found relative to GM foods currently on the market. b.

Gene transfer - Gene transfer from GM foods to cells of the body or to bacteria in the gastrointestinal tract would cause concern if the transferred genetic material adversely affects human health. This would be particularly relevant if antibiotic resistance genes, used in creating GMOs, were to be transferred. Although the probability of transfer is low, the use of technology without antibiotic resistance genes has been encouraged by a recent FAO / WHO expert panel. c. Out crossing - The movement of genes from GM plants into conventional crops or related species in the wild (referred to as "out crossing"), as well as the mixing of crops derived from conventional seeds with those grown using GM crops, may have an indirect effect on food safety and food security.

This risk is real, as was shown when traces of a maize type which was only approved for feed use appeared in maize products for human consumption in the United States of America. Several countries have adopted strategies to reduce mixing, including a clear separation of the fields within which GM crops and conventional crops are grown. 4.7 Impact on U. S Producers. S. producers who do not use food biotechnology are responsible for the substantial costs of proving it. It will cost U.S. producers of food biotechnology to put labels on their products, but also suffer severe sales loss in Europe due to the European consumers preference of not eating the GM products and will know they contain GM ingredients because of the label. 5. FUTURE Looking at goods and services combined, the EU and U.S. are each other's main trading partners and account for the largest bilateral trade relationship in the world.

The two markets have very similar export figures in agricultural products. For example, in 2002, the value of U.S. exports of agricultural products to the EU was $6.1 billion, accounting for about 10 percent of all U.S. agricultural exports. The main products exported were soybeans, tobacco, and animal feed, including corn gluten. The value of EU exports of agricultural products to the U.S., mainly wine and beer, was $7.9 billion.

Depending on the region of the world, people often have different attitudes to food. In addition to nutritional value, food often has societal and historical implications, and in some cases, may have religious importance. Technological modification of food and food production can evoke a negative response among consumers, especially in the absence of good communication on risk assessment efforts and cost / benefit evaluations. The future of the mandatory GM labeling will be affected by the decision the World Trade Organization comes up with. Under international trade laws, the EU regulations could be set aside if the WTO Panel concludes they constitute a trade barrier not supported by scientific evidence.

If the dispute is agreed in favor of the U.S. then they would be able to export GM foods to Europe, but I think Europeans will still not buy GM food because they are strongly against it. The U.S. should respect the European's culture and preferences. The latest news on this issue is "The Panel in European Communities - Measures Affecting the Approval and Marketing of Biotech Products (WT / DS 291, WT / DS 292 and WT / DS 293) indicated in its communication to the DSB of 20 August 2004 (WT / DS 291/26, WT / DS 292/20, WT / DS 293/20) that it expected to issue its final report to the parties by the end of March 2005. However, as a result of the time taken to identify and select experts and, more importantly, in view of a joint request by all four parties that they be granted additional time to prepare their further submissions to the Panel, it will not be possible for the Panel to issue its final report to the parties by the end of March 2005. The Panel estimates that it will issue its final report to the parties by the end of June 2005". In conclusion, the trade issue of genetically modified food will take a long time to solve and until then the agricultural trade dispute between the EU and the U. S will continue..