Agricultural Biotechnology Annual

An Expert's View about Agriculture and Animal Husbandry in Italy

Last updated: 15 Sep 2011

The European Union (EU) is dependent on imports of feed ingredients (mainly soybean and corn products) for its livestock and poultry industries, and its suppliers are also major producers of genetically engineered (GE) corn and soybean.

THIS REPORT CONTAINS ASSESSMENTS OF COMMODITY AND TRADE ISSUES MADE BY USDA STAFF AND NOT NECESSARILY STATEMENTS OF OFFICIAL U.S. GOVERNMENT POLICY Required Report - public distribution Date: 7/29/2011 GAIN Report Number: FR9074 EU-27 Agricultural Biotechnology Annual Annual Approved By: Lashonda McLeod Prepared By: Marie-Cecile Henard, Lashonda McLeod, and the group of FAS biotech specialists in the European Union Report Highlights: Due to the diversity of industry needs and public perceptions, Member States (MS) approach to biotechnology can be identified as the following: MS producing biotech crops; MS ready for adoption; MS with restrictive legislation and hostile public opinion, but supportive farmers and industry; and MS with the strongest opposition. The European Union (EU) is dependent on imports of feed ingredients (mainly soybean and corn products) for its livestock and poultry industries, and its suppliers are also major producers of genetically engineered (GE) corn and soybean. No GE animal is commercially produced in the EU; and GE animals are used for research purposes in medical and pharmaceutical applications. Section I. Executive Summary Despite the unified regulatory approach of biotechnology by authorities in the European Union (EU), Member States (MS) address this issue in multiple ways both in terms of policy and marketing. This is due in part to the diversity of industry needs (especially for feed products) and public opinions within the Member States. Four Categories of MS According to their Approaches to Biotechnology 1. GE producing MS include the Czech Republic, Poland, Portugal, Romania, Slovakia and Spain. They are all producers of GE crops, and farmers and industry welcome the technology; 2. MS ready for adoption due to the positive perception by the industry and the non-opposition by the public opinion are the Benelux, Denmark, Estonia, Finland, Lithuania, Sweden, and the United Kingdom (UK). However, in this group no GE crop is cultivated, as those authorized in the EU are not relevant for these markets; 3. MS with restrictive legislation and hostile opinion, but supportive farmers and industry are Bulgaria, France, Germany, Ireland, Latvia and Slovenia. These countries do not produce GE crops; however, France and Germany did produce GE corn in the past; 4. MS with the strongest opposition are Austria, Greece, Hungary, and Italy. In these countries, biotechnology has a negative image in the public opinion, national policies are restrictive, and the industry is not open to the technology. Imports meeting the needs of the animal feed industry, but hampered by trade barriers The EU policy on imports of GE products is less restrictive than that on GE crop cultivation, as it faces some market realities: the EU is dependent on imports of feed ingredients (mainly soybean and corn products) for its livestock and feed industry, and EU suppliers (principally the United States, Brazil and Argentina) of these products are also major producers of GE corn and soybeans. The largest category of GE products consumed in the EU consists of soybean meal, with roughly 30 million metric tons consumed annually in the EU. The second largest category of GE products consumed in the EU is Dried Distillers Grains (DDGs), which are corn products. EU imports of DDGs are booming in 2011, and the United States is the EU?s leading supplier. EU imports of GE products are, however, hampered by several types of trade barriers, including the national bans imposed on specific GE crops and the asynchronous approval between the EU and its suppliers. In February 2011, MS endorsed an EC proposal providing for a ?technical solution? designed to harmonize the implementation of the zero tolerance policy on non-authorized GE material in feed, and defining the lowest level of GE presence considered by the EU Reference Laboratory when validating detection methods as 0.1 percent. 2 Policy is changing and completed by national measures EU policy on biotech crop cultivation is based on a regulatory framework that is criticized as lengthy and countered by national bans imposed by seven MS on EU-approved products. In July 2010, the European Commission (EC) presented a package aimed at allowing MS to decide whether or not to cultivate approved biotech crops on their individual territories. Most MS oppose the proposal due to the disruption of the single internal market and potential WTO issues. Coexistence rules between biotech and non-biotech production are regulated by national authorities. The socio-economic aspects of biotech crop cultivation are a growing concern. In April 2011, the EC presented a report to the European Parliament and the Council demonstrating the current limitations in assessing the socio-economic implications of biotech crop cultivation in the EU. This complex, changing, two-layered policy framework on GE crop cultivation has resulted in only two products approved for cultivation. GE Animals ? Some Research, No Commercial Production There are no GE animals commercially produced in the EU. GE animals are principally used for research purposes for medical or pharmaceutical applications. Animal biotechnology regulation in Europe parallels regulation of plant biotechnology and some MS do have specific regulations on animal biotechnology. The report represents a group effort from the following FAS analysts: Stefano Baldi FAS/Rome Ornella Bettini FAS/Rome covering Greece Mila Boshnakova FAS/Sofia Monica Dobrescu FAS/Bucharest Jolanta Figurska FAS/Warsaw covering Poland, Latvia, Lithuania, and Estonia Bob Flach FAS/The Hague covering the Benelux Countries Marta Guerrero FAS/Madrid Marie-Cecile Henard FAS/Paris Roswitha Krautgartner FAS/Vienna covering Austria and Slovenia Diogo Machado FAS/Madrid covering Portugal Jana Mikulasova FAS/Prague covering the Czech Republic and Slovakia Ferenc Nemes FAS/Budapest Yvan Polet FAS/USEU/Brussels Piotr Rucinski FAS/Warsaw covering Poland, Estonia, Latvia and Lithuania Paul Spencer FAS/Berlin Asa Wideback FAS/Stockholm covering Sweden, Denmark and Finland Barrie Williams FAS/USEU/Brussels Jennifer Wilson FAS/London covering the United Kingdom and Ireland 3 Table of Contents Section I. Executive Summary ........................................................................................................ 2 Section II. Plant Biotechnology Trade and Production .................................................................. 4 A. Imports of Biotech Plant Products ........................................................................................ 4 B. Commercial Planting ............................................................................................................. 5 C. Research and Development - Field Trials of GE Crops ........................................................ 7 D. Confined Research ................................................................................................................ 7 Section III. Plant Biotechnology Policy.......................................................................................... 8 A. Commercialization ............................................................................................................... 8 B. Trade barriers ...................................................................................................................... 15 Section IV. Plant Biotechnology Marketing Issues ...................................................................... 19 A. Market Acceptance Issues Relating to the Sale of Biotechnology Products ...................... 19 Section V. Plant Biotechnology Capacity Building and Outreach ............................................... 23 Section VI. Animal Biotechnology ............................................................................................... 24 A. Use of Genetic Engineering ? Research and Production .................................................... 24 B. Regulation ............................................................................................................................ 25 C. Public Opinion..................................................................................................................... 25 Section II. Plant Biotechnology Trade and Production A. Imports of Biotech Plant Products EU plant biotech trade consists mainly of soybean and corn products imported for use in animal feed, human food, and planting seeds, as well as cotton products used in the textile industry. Current conditions indicate that EU production of feed grains will have some difficulties in meeting the feed demand from the livestock and poultry industry in 2011/12, which are likely to increase imports of feed ingredients, namely, soybean, and corn products. Poland bans GE seed trade, and plans to implement a ban on GE feed by January 2013. Agricultural experts are of the opinion that the actual implementation of the ban will be prevented before its due date. In Bulgaria, a new law in 2010 effectively prohibits trade in biotech seeds, even for research and development purposes. Soybean Products The largest category of GE products consumed by MS consists of soybean meal, which is the primary source of proteins for livestock. As the EU lacks adequate supplies of vegetable protein used in animal feed, meat producers are dependent on imports of soybean and soybean meal from the United States and South America. Exports of these commodities from the United States to the EU have declined significantly since 1997. More specifically, U.S. exports of soybeans and soybean meal to the EU have 4 averaged around $1 billion annually since 2006. Exports were up by almost 20 percent in the first three months of 2011. Over the past three years, 30-32 million metric tons (MT) of soybean meal were consumed annually (see annual EU-consolidated report on oilseeds dated April 7, 2011) in the EU. Domestic soybean production is marginal. With soybean and soybean meal imports averaging 12 and 22 million MT, respectively, Argentina, Brazil, and the United States are the major suppliers. The largest users of soybean meal, Germany, Spain, and France are also the major producers of livestock and poultry, with more than 40 percent of total EU consumption. GE products are estimated to represent more than 80 percent of the total soybean meal use by MS. The remainder consists of identity preserved (IP) and geographical indication sectors. Soybean meal remains an excellent ingredient both in terms of price and quality for feed compounders and livestock breeders. Corn Products Corn and corn products, mainly Corn Gluten Feed (CGF) and Dried Distillers Grains (DDGs), represent the second largest category of GE products used in animal feed. In the past three years, the EU corn consumption averaged 60-63 million MT annually; principally supplied by local production (averaging 55-59 million MT annually), rather than by imports (averaging 3,000-6,000 MT). The share of GE products out of total corn consumption is estimated to be lower than 25 percent. EU imports of DDGs doubled in the first ten months of marketing year (MY) 2010/11 (July/April). The United States is the leading supplier with 88 percent market share. The slow approval process of new GE events by the European Union has significantly impacted U.S. exports of CGF and DDGs to the Benelux region; however, there imports have recovered. There is also great potential for increasing DDG exports to France. Seeds for Planting The percentage of biotech corn out of the total corn grown in the European Union is limited. The leading producers of corn seeds for planting in the EU are France and Hungary. There is also production in Bulgaria and Romania. In 2011, Romania produced its own biotech corn seeds for planting, while in Bulgaria, non-biotech corn seeds are imported from other EU MS, Turkey, and the United States. German seed companies provide biotech seeds to U.S. farmers. These seeds, however, are not produced in Germany due to political opposition concerning the environmental release of GE crops. Portugal sources GE corn seed directly from the United States and Chile, but the majority is U.S. produced seed imported after repacking. Spain, the leading EU biotech corn producer, sources its GE seeds from South Africa, Romania, and Chile. The United States is not a source of biotech planting seeds because of the low of tolerance for adventitious presence of unapproved events in planting seeds. B. Commercial Planting The two GE crops authorized for cultivation in the EU are as follows: MON810 GE corn and the Amflora potato. Since 2007, the EU acreage of GE corn has remained relatively stable, with fluctuations between 93,000 and 110,000 hectares (ha). Spain remains the leading GE corn producer 5 with 85 percent of the total acreage. In 2011, Spain?s production is anticipated higher, triggered by last year?s high pressure of the corn borer, and with the overall increase of area planted to corn. Other producers are Portugal, the Czech Republic, Poland, Slovakia and Romania. In Portugal, planting intentions for 2011 have risen by about 50 percent to 7,300 ha due to a rise in the overall corn area (although the rise in GE corn area is proportionally higher) and corn borer attacks during the previous season. Farmers in Romania recognize the benefits of biotechnology, but several factors, such as specific requirements for separate storage and additional costs generated by implementing all specific EU rules negatively influence their planting decisions. In the Czech Republic, the decline in GE corn acreage results from the demand for non-biotech products from neighboring countries like Austria. GE corn is principally grown for domestic animal feed in Spain and Portugal. While in the Czech Republic and Slovakia, GE corn is used for feeding animals in small scale, as feedstock for biogas stations. GE Corn Cultivation by Selected Member States (in hectares) Member 2003 2004 2005 2006 2007 2008 2009 2010 2011 States (est.) Spain 32,249 58,219 53,226 53,667 75,148 79,269 79,706 76,575 80,200 Portugal 0 0 730 1,254 4,199 4,856 5,094 4,869 7,300 Czech 0 0 250 1,290 5,000 8,380 6,480 4,678 4,000 Republic Poland 0 0 0 100 100 300 3,000 3,500 3,900 Slovakia 0 0 0 30 930 1,930 875 1,281 1,000 Romania 0 0 0 0 331 7,146 3,400 822 590 Germany 0 500 342 947 2,685 3,171 0 0 0 France 17 17 500 5,200 22,135 0 0 0 0 Total GE corn 32,266 58,736 55,048 62,458 110,528 105,052 98,555 91,725 96,990 acreage Total Corn Acreage 9,138 9,677 9,169 8,492 8,444 8,854 8,284 8,000 8,600 (1,000 ha) Source: FAS Posts GE potato production is estimated to remain marginal in 2011 (20 hectares), and all located in Sweden. The cultivation of the Amflora potato will be significantly lower in 2011, due to the discovery of an unapproved GE potato last year. This resulted in stricter control measures for cultivating Amflora, thus making it practically impossible to cultivate larger areas. The Czech Republic and Germany reduced their production of GE potato to zero in 2011 as a result of efforts aimed at focusing more on planting material in the next years. 6 EU-27 acreage on GE Potato by Selected Member States (in hectares) Member State 2010 2011 (estimate) Sweden 150 20 Czech Republic 147 0 Germany 15 0 Total Amflora Potato Acreage 225 20 Source: FAS Posts C. Research and Development - Field Trials of GE Crops Agricultural biotechnology research is a stated priority of the European Commission and many Member States. Previously, researchers and universities implemented successful field trial activities. However, anti-biotech activists have succeeded in intimidating research groups (both public and private entities) to drop field trial work. Field destructions have continued with little or no response from police and judicial authorities. As a result, permit requests to conduct field trials have fallen dramatically since 2007. Some research scientists were forced to drop activities due to political pressure or have moved to institutions where support for such research is undeterred. Due to strict regulations and hostile public opinion, there are no field trials in Austria, Belgium, Bulgaria, Greece, Ireland, Lithuania, Estonia, Latvia, Italy and Slovenia, and a limited number in Denmark, France, Germany, Slovakia and Sweden. In the Czech Republic (virus-resistant plum trees), the Netherlands (potatoes), Poland (coexistence studies), Portugal (corn), Romania (corn), Spain (corn, sugar beet, cotton, potatoes), and the United Kingdom (nematode-resistant and blight- resistant potatoes) open field test plots are conducted at a larger scale. D. Confined Research With less strict regulations and little or no visibility for public opinion, there is confined research conducted by public entities. In Austria, for example, the University of Natural Resources and Life Sciences is working on a project that investigates biotech fruit trees under contained conditions. France?s National Institute for Research in Agriculture partners with private entities in research programs on crop genomics, a variety selection program of corn with high yields and limited needs in water and chemicals, as well as a variety selection program of wheat with high yields and quality, but stress tolerant. In Germany, four big research organizations (Max-Planck-Society, Leibniz Association, Helmholtz Association, Fraunhofer-Gesellschaft), universities, technical colleges, and non- academic research institutes play a central role in biotech development. In Hungary, the main research institutes belong to the Hungarian Academy of Science, the Ministry of Rural Development, and universities. For Poland, plant biotechnology research is conducted by several research institutes, in 7 some cases in cooperation with foreign companies or laboratories. There is also confined research reported in Portugal, Slovenia, Spain, and in the United Kingdom. Section III. Plant Biotechnology Policy A. Commercialization 1. EU -27 biotechnology regulatory framework Typically, biotech events1, either for placing on the market or for release into the environment, are subject to the following regulatory framework: a. Authorization for placing biotech events on the market for food or feed use2 Authorization is required for placing (import, distribution, processing) biotech events on the EU market. To obtain authorization the following is required: An application3 is sent to the appropriate national competent authority of a Member State. That competent authority acknowledges receipt of the application in writing to the applicant within 14 days of receipt, and transmits the application to the European Food Safety Authority (EFSA). EFSA informs other MS and the European Commission of the application without delay, and makes it available. EFSA also makes the summary of the dossier available to the public via the internet. EFSA is obliged to respect the time limit of six months from its receipt of a valid application to give its opinion. This six month limit is extended whenever EFSA (or a national competent authority through EFSA) requests supplementary information from the applicant. EFSA forwards its opinion on the application to the European Commission, the MS, and the applicant. EFSA also makes its opinion available for public comment within 30 days from publication. 1 In the EU, biotech events are commonly referred to as Genetically Modified Organisms (GMOs) 2 Regulation (EC) No 1829/2003 of the European Parliament and of the Council 3 The application is accompanied by inter alia: - name and address of the applicant; - designation of the food, and its specification, including the transformation event(s) used; - a copy of the studies which have been carried out and any other available material to demonstrate no adverse effects on human or animal health or the environment; - methods for detection, sampling and identification of the event; - samples of the food; - where appropriate, a proposal for post market monitoring; - a summary of the dossier in standardized form. A complete list of accompanying information is provided in Article (5) 3 for food use, and Article 17 (3) for feed use of Regulation (EC) No 1829/2003. 8 Within three months after receiving the opinion from EFSA, the European Commission presents its Standing Committee on the Food Chain and Animal Health (SCoFCAH - composed of representatives of the MS) with a draft decision reflecting EFSA?s opinion. The Standing Committee votes on the draft decision. For draft decisions prior to March 1, 2011, in the case of no qualified majority (qualified majority being 255 votes out of 345) in favor of the draft decision, the European Commission submits it to the Council of the European Union (typically the Agriculture Council) without delay. If the Council has neither adopted the draft decision nor opposed it by qualified majority within three months from the date of referral, it is adopted by the European Commission. Draft decisions after March 1, 2011, are subject to the procedural rules resulting from the Lisbon Treaty. Under these rules, in the case of no qualified majority in favor of the draft decision, the Commission may either submit an amended draft to the Committee or submit the original draft to the Appeal Committee (comprised of senior officials from the Member States). If the Appeal Committee has neither adopted the draft decision nor opposed it by qualified majority within two months from the date of referral, it may be adopted by the European Commission. It should be noted that the post-Lisbon procedural rules give more discretion to the Commission ? whereas before Lisbon the Commission was obliged to adopt the draft decision, after Lisbon the Commission has the choice whether or not to adopt the draft decision. Authorizations granted are valid throughout the EU for a period of ten years. They are renewable for ten year periods on application to the European Commission by the authorization holder at the latest one year before the expiry date of the authorization. This application for renewal of authorization must include inter alia any new information which has become available regarding the evaluation of safety and risks to the consumer or the environment. Where no decision is taken on the renewal before the authorization?s expiry date, the period of authorization is automatically extended until a decision is taken. b. Authorization for deliberate release into the environment of biotech events4 The standard authorization procedure requires written consent of the appropriate competent authority to be given before the deliberate release into the environment (cultivation for which no specific containment measures are used) of a biotech event. To obtain written consent, the following applies: The person wishing to undertake the release must submit a notification5 to the appropriate national competent authority of the MS within whose territory the release is to take place. The national competent authority acknowledges the date of notification receipt. The national competent authority sends to the European Commission, within 30 days of receipt, a scientific opinion on each notification received. 4 Directive 2001/18/EC of the European Parliament and of the Council 5 The notification includes inter alia: - a technical dossier supplying the information necessary for carrying out an environmental risk assessment; - the environmental risk assessment and the conclusions, together with any bibliographical reference and indications of the methods used. Complete details are provided in Article 6 (2) of Directive 2001/18/EC. 9 The European Commission, at the latest 30 days following receipt, forwards the opinion to the other MS which may, within 30 days, present observations through the Commission or directly. The national competent authority has 45 days to evaluate the MS?s observations. If these observations are in line with the national competent authority?s scientific opinion, that opinion is sent to the European Commission which, in turn, presents a draft decision reflecting the opinion to its Committee for the adaption to technical progress and implementation of the Directive on the deliberate release into the environment of genetically modified organisms (GMOs). The Committee votes on the draft decision. In the case of no qualified majority in favor of the draft decision, the European Commission submits it to the EU Agriculture Council without delay. If the Council has neither adopted the draft decision nor opposed it by qualified majority within three months from the date of referral, it is adopted by the European Commission. Those draft decisions that have been put to the Committee after March 1, 2011, are subject to the procedural rules resulting from the Lisbon Treaty (as described in section A above). If, on the other hand, the MS?s observations are not in line with the national competent authority?s scientific opinion, the matter is passed to EFSA for its scientific opinion. EFSA?s opinion is then sent to the European Commission which presents a draft decision reflecting EFSA?s opinion to the Committee for the adaption to technical progress and implementation of the Directive on the deliberate release into the environment of genetically modified organisms. The Committee votes on the draft decision. In the case of no qualified majority in favor of the draft decision, the European Commission submits it to the EU Environment Council without delay. If the Council has neither adopted the draft decision nor opposed it by qualified majority within three months from the date of referral, it is adopted by the European Commission. Draft decisions after March 1, 2011, are subject to the procedural rules resulting from the Lisbon Treaty (as described in section A above). 2. Proposal for MS to be allowed to decide on cultivation of biotech crops on their territories Commission Proposal On July 13 2010, the Commission presented a package aimed at allowing MS to decide whether or not they cultivate approved biotech crops on their individual territories. The package consists of a ?fast solution? and a proposal for a legislative amendment to the governing legislation and a proposal for a legislative amendment to the governing legislation. The ?fast solution? essentially implies new guidance on isolation distances recommended to ensure co-existence between biotech and traditional crops. Those MS that do not wish to cultivate biotech crops are, in practice, able to use the new guidance to impose isolation distances which would effectively preclude the possibility of biotech cultivation. As this does not imply legislative amendments, the Council and the European Parliament are not required to approve the measure which was applicable immediately. At the time of this report, it is understood that no MS has used this facility. 10 The proposal for legislative amendment would allow a MS to formally ?opt out? of biotech crop cultivation and requires approval by the Council and the Parliament. It is understood that the Commission would be prepared to withdraw the proposal for legislative amendment if it were to encounter significant opposition. The report on the Commission?s proposal made by the European Parliament?s Committee on the Environment, Public Health and Food Safety (Lepage report) was voted July 2011. Inter alia, the Lepage report adds environmental grounds as a justification for banning or restricting the cultivation of biotech crops. The Council has not reached a common position on the Commission?s proposal. As no deadline is imposed on the Council for reaching one and it is not certain that the incoming Polish Presidency of the Council of the European Union will treat the issue as a priority. It seems unlikely that a common position will be reached in the medium term. As such, the Commission?s proposal will be frozen until the Council reaches a common position. Reactions of the Member States Several MS are also opposed to the Commission proposal because of disruption of the single internal market and potential WTO issues. France continues to request for the implementation of the Environment Council of December 4, 2008 under the French Presidency of the EU to reinforce the environmental impact assessment and EFSA?s independence. Germany does not support the European Commission proposal. The government of the Netherlands opposes a study for the marketing approval for GE products by the Member State, in addition the study of the EFSA. According the Dutch government, the discussion about the use of such criteria should be held on an international level. Spain has reacted cautiously to the Commission?s proposal. Spain?s concerns are the compatibility with the common internal market and the compliance with WTO rules. The UK government is cautious about renationalization of cultivation approvals as there is potential for fragmentation of policy. Scotland, Wales and Northern Ireland have authority over cultivation on their soil. From the start, the UK government questioned the legal status of the renationalization concept, and the viability of attaining robust socio-economic criteria. Austria is in favor of the GE opt-out? clause to allow individual member states to decide on cultivation. While the current Estonian government is using a science based approach to biotech products, it is not supportive of planting GE crops. One hundred percent of Estonian Members of the European Parliament (MEP) voted for the proposal. Ninety-one percent of Lithuanian MEP voted for the proposal The Latvian government is openly against plant biotechnology, including planting. According to the current Law on Circulation of Genetically Modified Organisms a local government may already determine a prohibition by issuing binding rules for the cultivation of genetically modified crops in 11 the relevant administrative territory or in a particular territory thereof upon its own initiative or on the basis of a proposal of a person. Over 88 percent of Latvian counties already declared themselves as biotech-free territories. One hundred percent of Latvian MEP voted in favor of the European Commission?s proposal. The Polish Minister of Agriculture declared that this move, which transfers the decision making on GE cultivation in MS from EU/Brussels to MS, could disrupt ?the single internal market.? Ninety percent of Poland?s MEP voted for the proposal. The Portuguese government has been in favor of the Commission?s proposal following the orientation of the Ministry of Environment that was, until now,the responsible body for regulating cultivation. A reviewed position, however, is possible in the near future as a new Government has just been elected and there is now one single Ministry for Agriculture and the Environment. Agriculture has traditionally been against the Commission?s proposal fearing the effects of the pressure from anti-biotech NGOs and the media if such a proposal were to be approved. The Portuguese Autonomous Region of Madeira has become the first Region of the EU to declare itself a zone free of the cultivation of genetically modified organisms since the European Commission made its proposal. The Regional Government of Azores is also preparing the submission of a request to the Commission for the same purpose. GE corn is cultivated in the Azores for the first time this year. 3. National coexistence rules Some MS have set up national coexistence frameworks for organic, biotech, and conventional crops. Austria has no federal coexistence law but all nine provinces implement precautionary bills that include coexistence regulation. The Czech Republic recently updated coexistence rules to remove administrative duplicities and add rules for future situations, such as growing GE soybeans. In 2005, Denmark was the first EU MS to impose coexistence rules. Portugal was one of the first countries to create legislation that recognizes the right of farmers to voluntarily associate and establish both GE Production Zones (PZ) and GE-Free Zones (FZ). In GE production zones farmers are still mandated to fulfill all legal obligations related to farming GE varieties, namely completing training requirements and notifying the State and adjacent farmers about their GE crop farming intentions. Except for limit zones, farmers in PZ are exempt from applying measures to minimize the accidental presence of GE material, be it through pollen contamination or mechanical mix. In 2010, twenty-one production zones were active, accounting for 46 percent of total biotech corn planted area. Germany?s approach to coexistence between biotech and conventionally grown and organic crops is complex and changing. German federal and local governments have put into place an assortment of planting bans, segregation distances, and other requirements. In December 2010, a scientific policy advisory board for the German Ministry of Food, Agriculture, and Consumer Protection published additional recommendations on coexistence. While not binding, the recommendations, which call for economically unrealistic segregation and cultivation measures, underscore how coexistence regulations can be used to discourage farmers? adoption of biotech crops. Several MS are currently preparing coexistence rules. The French biotech authority, the High 12 Council on Biotechnology (HCB), is expected to release coexistence recommendations within the next few months in 2011. This will be based on its recent recommendations on the definition of ?non-biotech? and on the obligation of declaration of GE crop producers. A decree on the ?non- biotech? definition is currently being reviewed by French government, to be published in the Official Journal. Poland is proposing restrictive coexistence measures on the crops under new legislation, which is expected to be completed by early 2012. While Spain remains the leading GE crop producer in the EU, no developments regarding coexistence have been made due to the lack of consensus among the interested parties. To date, coexistence has been managed following the good agriculture practices promoted by the National Association of Seed Breeders (ANOVE), which are published on a yearly basis. Similarly, there are no coexistence rules in the United Kingdom. 4. Field register status In Austria, Belgium, Bulgaria, the Czech Republic, Denmark, France, Germany, Greece, the Netherlands, Romania, Slovakia, and Portugal farmers producing biotech crops must register their fields with governmental bodies. The specificity of these registration requirements varies greatly from country to country, and tends to discourage farmers from growing biotech crops. The implementation of a commercial GE plots register is being discussed in Spain. 5. Evaluation of the EU legislation framework in the field of cultivation and marketing In December 2008, the Commission launched a technical evaluation of a) the regulatory framework of the cultivation of biotech crops under Directive 2001/18/EC on the deliberate release into the environment of biotech events and b) Regulation (EC) No 1829/2003 on biotech food and feed and the marketing of their other uses under the Directive. The aim of the evaluation is to assess the extent to which the legislative framework on the cultivation and marketing of biotech products and if its implementation have achieved its objective of protecting human and animal health, the environment and consumers' interest, while ensuring the effective and efficient functioning of the internal market. The evaluation will cover topics such as risk assessment, management and communication, authorization procedures, national safeguard measures, inspections and controls and confidentiality rules. The contractor of this exercise is GHK, member of the European Policy Evaluation Consortium (EPEC) consortium. Within the framework of its task, it will analyze the biotech legislation, documents, reports, and studies related to its implementation. Moreover, it will consult stakeholders, including the MS' Competent Authorities under the biotech legislation, professional associations, biotech industry and civil society organizations involved in biotechnology issues. Commission sources suggest that the results of this work are to be released during 2011. 6. Environmental risk assessment guidance Directive 2001/18/EC provides that the potential adverse effects on human health and the 13 environment are accurately assessed on a case-by-case basis. This assessment shall be conducted jointly by MS and EFSA in accordance with the principles of the Directive 2001/18/EC and the supplementary guidelines. Following a specific mandate of the Commission to EFSA in March 2008, supported in the Environment Council Conclusions of December 2008, an updated version of the current environmental risk assessment (ERA) guidance was published by EFSA on November 12, 2010. In parallel, EFSA delivered an opinion to address the evaluation of potential impact of biotech plants on non-target organisms (NTOs). The Commission is continuing the discussion on ERA guidance with MS to clarify the specific aspects of this guidance before being transformed into a legal text. This guidance will be the basis for applicants when submitting applications for biotech authorization and for MS and EFSA when assessing the environmental risk of biotech plants. 7. Updated guidance for food and feed risk assessment of biotech plants ? EFSA On May 24, 2011, EFSA published updated guidance for the risk assessment of food and feed derived from biotech plants. The document expands on previous EFSA guidance and reflects scientific developments in areas such as assessment of allergenicity and selection of the conventional comparator plant against which the biotech plant is compared. It also establishes a new statistical methodology aimed at strengthening the risk assessment of biotech plants. The European Commission has announced that it will move ahead with a Regulation capturing and imposing this more stringent EFSA guidance. 8. New Plant Breeding Techniques Directive 2001/18/EC provides for a general definition of GMOs. The Directive includes annexes which give additional information regarding the breeding techniques that may or may not result in genetic modification, or that result in genetic modification but yield organisms that are excluded from the scope of the Directive. As agreed by a meeting of the MS? Competent Authorities, in October 2007, the Environment Directorate of the European Commission established an expert Working Group on new breeding techniques (Directive 2001/18/EC) and GMOs under contained use (Directives 90/219/EEC and 98/91/EC). The aim of this exercise is to harmonize MS? interpretation on whether or not newly applied techniques result in a GMO or not. The Working Group is evaluating the following new breeding techniques in light of the most recent scientific data: Zinc Finger Techniques (ZFN) Oligonucleotide-directed Mutagenesis (ODMG) Cisgenesis RNA-dependent DNA-methylation Grafting Reverse Breeding Agroinfiltration 14 Synthetic Biology The Working Group aims to: a. Classify current technologies and ascertain whether they fall under the current definition of a GMO as defined in Directive 2001/18/EC; b. Check if some techniques may be exempted for technical or practical reasons. During the spring of 2010, the Commission?s Health and Consumers Directorate took over the coordination of the Working Group from the Environment Directorate. To date, the Working Group has met nine times and is currently finalizing a technical report that will be presented at a meeting of the MS? competent Authorities. In parallel to this exercise, the Joint Research Center (JRC) has recently finalized a report focusing on those breeding techniques entitled, ?New Plant Breeding Techniques: Adoption and Impact of Policy Options.? The JRC is organizing a closed international policy meeting in Seville on September 12-13, 2011 to which government representatives from Argentina, Australia, Canada, Japan, South Africa and the United States will be invited. The aim of the meeting will be to improve understanding of those countries? classification policy. Clearly, if a product were not to be classified as GM in the United States but were to be in the EU for example, U.S. trade would be significantly impeded. B. Trade Barriers 1. Safeguard clause Where a MS, as a result of new information, has detailed grounds for considering that an approved biotech event constitutes a risk to human health or the environment, the MS may invoke a safeguard clause on the biotech product; its use would be provisionally restricted or prohibited on its territory. The MS must ensure that in the event of a severe risk, emergency measures (including suspension or termination of the placing on the market, and provision of appropriate information to the public) are applied. The MS must immediately inform the Commission and the other MS of actions taken and give reasons for its decision. The MS must provide its review of the environmental risk assessment, indicate whether and how the conditions of the consent should be amended or the consent should be terminated, and, where appropriate, the new or additional information on which its decision is based. In an effort to dissuade MS from abusing the safeguard clause system and to comply with its role as ?Guardian of the Treaties,? the European Commission has developed a package aimed at allowing MS to decide on whether or not to cultivate EFSA approved biotech crops on part or all of their respective territories. Detailed Safeguard Clause by MS and by Event Banned Country Event Banned Scope Date of Ban Austria Bayer T25 corn, Cultivation 2000 (Amended 2008) Monsanto MON 810 corn Cultivation 1999 (Amended 2008) 15 Monsanto GT73 rapeseed Import/Processing 2007 (Amended 2008) Monsanto MON 863 corn Import/Processing 2008 Bayer Ms8 rapeseed Import/Processing 2008 Bayer Rf3 rapeseed Import/Processing 2008 Bayer Ms8XRf3 rapeseed Import/Processing 2008 BASF EH92-527-1 potato Cultivation 2010* Bulgaria Monsanto MON810 Cultivation 2010* France Bayer Rapeseed Topas 19/2 Import/Processing 1998 Bayer MS1XRf1 rapeseed Monsanto MON 810 corn Import/Processing 1998 Cultivation 2008 Germany Syngenta Bt176 corn Cultivation 2000 Monsanto MON 810 corn Cultivation 2009 Greece Bayer Rapeseed Topas 19/2 Import/Processing 1998 Syngenta Bt176 corn Monsanto MON 810 corn Cultivation 1997 Bayer T25 corn Cultivation 2001 Bayer MS1XRf1 rapeseed Import/Processing 1997 Monsanto MON810 corn Import/Processing 1998 Cultivation 2010* Hungary Monsanto MON 810 corn Cultivation 2005 EH92-527-1 Amflora Potato Cultivation/Feeding 2010* Luxemburg Syngenta Bt176 corn Cultivation 1997 Monsanto MON 810 corn Cultivation 2009 Source: FAS Posts *Most recent bans In Austria and Greece, all EU approved biotech crops are banned for cultivation. Greece maintains a zero-tolerance policy for GE cotton seeds for planting, requiring laboratory certification prior to shipment from the United States. Bulgaria?s 2010 biotech law mandates that the Minister of Agriculture initiate a safeguard clause whenever another EU Member State decides to apply a safeguard clause for that same crop on its own territory. The draft law introduced in Parliament in May 2010, which intends to prohibit biotech crops planting in Romania for 5 years, is still under debate. On June 18, 2009, Latvia modified its Law on Circulation of Genetically Modified Organisms to allow local municipalities self-determination on the cultivation of bioengineered crops within their jurisdiction. Since then, eighty-eight percent of Latvian municipalities have either banned or are in the process of banning cultivation of bioengineered crops in response to consumer activism and tacit support from the Ministry of Environment. Hungary amended the legislation governing seed imports in March 2011. Under the new Order of 16 the Minister of Rural Development, each seed lot imported from non-EU countries has to be tested. The former legislation ordered random testing only. For biotech content Hungary declared zero tolerance. The official laboratory of the Central Agricultural Office (MgSzH) declared several corn seed samples positive for biotech DNA content. The Ministry has recently ordered the destruction of 950 hectares of corn and soybean fields planted with the seeds of concern. Italy appears likely to invoke the safeguard clause. For the past decade, Italy has maintained a de facto ban on the cultivation of biotech crops by failing to develop necessary regulations. Observers speculate that Italy will provide some type of evidence to support its request not to cultivate EU- approved biotech crops and that the European Commission will not reject the request even though EFSA has determined that the crops are safe. 2. Policy on Low Level Presence (LLP) Asynchronous approval has resulted in the detection in U.S. shipments to the EU trace amounts of events that have been deregulated for commercial use in food and feed in the United States but not authorized in the EU. The EU?s policy of zero tolerance implies that shipments containing low level presence (LLP) of EU unapproved events are not allowed into the European Union. Although the most significant impact has been on U.S. soy, other products (notably rice and corn products) have also been affected. On February 22, 2011, Member States at the Standing Committee on the Food Chain and Animal Health (SCoFCAH) endorsed a Commission proposal providing for a ?technical solution? designed to harmonize the implementation of the zero tolerance policy on non-authorized genetically engineered material in feed. The proposal aims at addressing uncertainty faced by EU operators when placing on the market feed based on imports of raw materials from non-EU countries. This technical solution defines the lowest level of GE presence that is considered by the EU Reference Laboratory when validating detection methods, as 0.1 percent. It is limited to GE feed material authorized for commercialization in a non-EU country and for which an EU authorization request for the biotech event in question has been lodged with EFSA for at least three months or of which the authorization has expired. Feed will be considered non-compliant with EU legislation when the presence of this GE feed material is, after due consideration of the margin of error, above the technical zero of 0.1 percent. This draft regulation was subject to the scrutiny of the European Parliament and of the Council for three months following their formal receipt of the draft. In the absence of opposition to the draft from either of those institutions within that time period the draft was adopted (Commission Regulation (EU) No 619/2011) and entered into law from, July 20, 2011. The EU farmer association, COPA-COGECA, had pressed for an end of the EU?s zero tolerance policy prior to the decision to accept the 0.1 percent tolerance threshold. The association is reported 17 to have underlined that, given the bulk handling of grains in international trade, compliance with a zero tolerance policy is impossible. The new rules are still too restrictive. Additionally, it is not possible in practice to separate biotech-based animal feed from biotech seeds and food. As such, zero tolerance could be replaced by a practical tolerance threshold in all three areas. The draft regulation includes a recital stating that the ?? rules should be adapted if this becomes necessary to take account of new developments in particular as regards their impact on the internal market and on food and feed operators.? As such, the Commission has explicitly acknowledged the possibility of including food within the scope of the measure in the future. The Commission?s services have indicated that after the threshold for feed is adopted, the scope will be extended to include food at a later stage. The absence of food within the scope of the new rules clearly implies inter alia that trade in U.S. rice to the EU will continue to be subject to a system of absolute zero tolerance where zero equals zero, and that normal trade levels will be compromised. 3. Socio-Economic aspects of biotech cultivation Commission Report On April 15 2011, in response to the Conclusions of the Environment Council of December 2008, the Commission presented a report to the European Parliament and the Council demonstrating the current limitations in assessing the socio-economic implications of biotech crop cultivation in the EU. More specifically, the report (based on information principally provided by MS) demonstrates that the existing information is often statistically limited and is based upon preconceived ideas about biotech crop cultivation. In the report, the Commission presents an analysis of the socio-economic dimensions of biotech cultivation as reported in the international scientific literature and in the conclusions of research projects funded under the European Framework Program for Research. Since the EU represents only a fraction of global surface dedicated to biotech crops, European experience in the matter is limited. The report asserts that the contributions from MS: ??highlight that the present or future socio-economic impacts of (biotech crop) cultivation in Europe, across the food chain and the society as a whole, are often not analyzed in an objective manner.? As such, the Commission views the report as a starting point for the MS, the Commission, the European Parliament and all interested parties to deepen their reflection on the issue. It considers that discussions should shift from the polarized perceptions documented in the report to a more tangible and objective basis. Therefore, the Commission recommends defining a set of factors and indicators to capture the socio-economic consequences of biotech crop cultivation across the EU and along the food chain. The Commission also suggests initiating a reflection on the potential use of the improved understanding of the socio-economic dimension in the management of biotech crop cultivation. 18 MS Individual Situations on Socio-Economic Criteria France is the only MS with a biotech regulatory framework that includes a socio-economic review of biotech products, in addition to the scientific review. The High Council on Biotechnology, created by the 2008 law on biotechnology, includes both a social, ethical and economic committee and a scientific committee. The governments of Austria, Estonia, Finland, Hungary, Latvia, Lithuania, the Netherlands, Poland, Slovakia and Sweden favor the use of socio-economic criteria for the approval of GE products. Sweden is interested in keeping the indicative list of grounds to restrict or ban biotech crop cultivation outside the legal act since it believes that many of the grounds are not WTO-compatible. Section IV. Plant Biotechnology Marketing Issues A. Market Acceptance Issues Relating to the Sale of Biotechnology Products There are four categories of MS according to their domestic policy, farmer and industry approaches, and public opinion on biotechnology: GROUP 1 - GE producing MS are the most open to the technology - Czech Republic, Poland, Portugal, Romania, Slovakia and Spain All are producers of GE crops, and farmers and industry welcome the technology. In this group, Poland and Romania are, however, facing potential policy changes towards more restrictive measures, while the other MS have a more pragmatic approach. The Parliament in Poland initiated a restrictive legislative proposal pertaining to agricultural biotechnology. The proposed requirements are expected to prevent planting of modified crops on a commercial scale. New legislation is expected to be completed by early 2012. The livestock sector depends on feed imports from third countries, mainly soybean meal, which in most cases, is genetically modified. Animal producer groups see the need for maintaining the import of feed with biotech content in order to compete within the EU market. Many scientists promote the technology, but are also attacked for their views. There is no resistance from consumers, as this meat produced with GE feed does not have to be labeled. The public opinion is very negative. Very active, well funded, anti-biotech movements exist. Political parties are cautious, being rather on a negative side. Farmers in Romania have difficulty in finding markets for their biotech production. They have to offer it at a significant discount, so that customers will cover expenses they incur in complying with traceability rules (supplementary documents, separate storage, etc). In this way the farmers? profitability is affected. There was once commercial production of GE soybeans before accession to the EU. The current government has, in general, an open attitude towards biotechnology, as well as on decisions being adopted based on scientific opinions and standpoints released by the academic institutions. The Czech Republic recently updated regulations to alleviate the constraints imposed on farmers, 19 especially in terms of notification of their cultivation of GE crops. The manual that explains the rules and changes is available at the following link: http://eagri.cz/public/web/file/48548/AM_03_2010_Zmena_pravidel.pdf. In the Czech Republic and Slovakia, most of the GE corn is used as a feedstock for biogas stations. Milk and meat buyers require a statement that the animals were not fed on GE corn. This is not consistent with the fact that the main protein source in feeds in the Czech Republic is soy, which is mainly imported and biotech. Portugal?s perspective on the growing of GE varieties has been traditionally moderate. As a net importer of soybeans and corn for feed, poultry, pork, and feed associations are in favor of increasing imports of GE feed materials. There, however, are organized anti-biotech NGOs with a presence in the media and influence in the Former Environment Ministry, now merged into one with Agriculture, Forests, and Fisheries. Some corn producers with supply contracts with food companies are reticent to the use of biotech varieties because of the complicated and hard to implement segregation measures. Spain, which was traditionally one of the most open MS to biotechnology, abstained in recent votes on biotech products at the EU level. Most of Spain?s farmer associations are in favor of planting biotech crops. Spain is one of the major livestock producers within the EU; its structural shortfall of grains and oilseeds makes its trade, feed and livestock sectors traditional supporters of biotech. Meat produced with GE feed does not have to be labeled, thus there is not a strong reaction from retailers or meat consumers. Sweden did not import biotech products or crops. Since January 2006, however, when the meat industry lifted its ban on biotech feed, small quantities of biotech soy products have been imported. While demand for this product is limited, there is reportedly no negative reaction from the trade. The food processing and retail sectors remain concerned about the possibility of negative consumer reaction and anti-biotech demonstrations. The Finnish meat industry followed the Swedish example and abandoned its ban on biotech feed in 2007. GROUP 2 - MS ready for adoption (positive perception by the industry and the non-opposition by the public opinion) - Benelux, Denmark, Estonia, Finland, Lithuania, Sweden, and the United Kingdom In this group, no GE crop is cultivated to date. These countries have a pragmatic approach and other GE crops, which are more appropriate to local markets and natural conditions could be adopted. The Benelux livestock sector depends on feed imports from third countries, mainly soybean meal, which is mainly genetically modified. There is no resistance by consumers as the meat produced with GE feed does not have to be labeled. The Dutch Farmers Organization (LTO) and Belgian Farmers Organization (Boerenbond) are both pragmatic and in favor of planting biotech crops. Both organizations point to the resistance of retailers and consumers towards food products containing biotech components, in particular in export markets such as Germany. The Danish meat industry has long been using GE feed in its animal production. Denmark imports 70 percent of its soybean meal from Argentina. The Ministry of Agriculture in Lithuania appears moving in direction of a science-based policy by its efforts to attract scientific seminars, source scientific publications, and arrange educational opportunities for young professionals in the United States. Additionally, rapeseed producers are vocal supporters of the Ministry?s efforts. 20 In the Netherlands, the government is pragmatic as a significant share of the economy is based on imports. The government differentiates biotech policy for imports and for domestic production. Dutch farmers are generally not in favor of cultivating GE crops. For Sweden, the government is generally considered to be more open to biotechnology than the industry. The UK approach remains pragmatic and science-based with the new government coalition, although not identified as a top priority. Private label dominates the supermarket sector and all retailers have a similar non-biotech policy for their goods. However, given the labeling derogation for animals reared on biotech feed, the majority of soy meal incorporated into swine rations is biotech in origin. Until recently, all private label poultry was fed non-biotech. Asda (Walmart) took the decision to source from members of the Round Table on Responsible Soy and have made sustainability the main factor in sourcing their soy, not non-biotech feed. Other retailers, such as Tesco, are reportedly following suit, incorporating sustainability as part of the normal food chain sourcing protocol. The increasing lack of availability and rising price premiums for non-GE are strong drivers for putting sustainability at the heart of retail sourcing as opposed to the question of GE or non-GE. GROUP 3 - MS with restrictive legislation and hostile opinion, but open farmers and industry - Bulgaria, France, Germany, Ireland, and Latvia These countries do not produce GE crops, but farmers are generally open to the technology. In addition to the extremely restrictive biotech law of 2010, Bulgaria has two other regulations (amendments to the Food Law) that impose extreme requirements on the labeling and ban on sales of foods containing GE products in schools, kindergartens, and nurseries. The ban is valid for all GE products regardless of whether or not they are approved by the European Commission. The Bulgarian livestock sector depends entirely on feed imports from third countries, mainly soybean meal. Since the local livestock industry and consumers are very price sensitive, all imports are genetically modified. There is no resistance by consumers, as this meat produced with GE feed is not labeled. Poultry and Pork Producers Associations are in favor of importing biotech crops as long as this is done quietly and will not hurt animal products sales. However, the public opinion is very negative, and import restrictions are supported by all green and consumer organizations. The media is vocal and does not publish anything in support of biotechnology. Political parties do not support biotechnology and farmer organizations are not united. In the past few years, France has taken various steps to prevent biotech crop cultivation, including the incorporation of the precautionary principle into its Constitution, the Ministry of Ecology taking the lead on biotechnology issues, the incorporation of socio-economic perspectives as part of the official biotech dossiers review, and the national ban on MON810 corn. The industry is divided on the biotechnology issue. The feed and livestock industry is pragmatic and imports biotech soybean and corn derived products, for which demand is high. The public opinion and retailers have significant demands for non-biotech sectors, such as organic and high-end products marketed under Geographical Indications. Most French farmers favor the technology and some consider the national ban on GE corn is affecting their competitiveness. Germany also imposes a national ban on MON810 corn, mainly driven by the Green political forces. 21 The Ministry of Agriculture, however, is open to dialogue with the biotech industry. There is little prospect for near or medium-term acceptance of biotech crops, either from a regulatory or marketing perspective. A whole generation of Germans has grown up under the assumption ? echoed by major political parties, NGOs, and the media ? that biotech crops are bad. Among the political class, biotech crops are recognized ?third rail? that in any political calculus is not counterbalanced ?pro-biotech? forces. The food retail sector is concentrated and reluctant to support biotech policies that might be considered anti-consumer by either NGOs or competitors. The public arguments against biotech crops are shifting, border on urban myth, and are often mixed with anti-capitalist sentiment. The Government of Latvia is openly negative towards biotechnology and encourages local municipalities to consider banning cultivation of crops enhanced through this technology. The agrarian sector is attempting to counter this activism. The livestock industry realizes it needs better access to animal feed, and currently gained approval to import U.S. origin soybeans into the market (after a break of several years due to the country?s zero biotech tolerance policy). Only biotech feed can be found on the Slovenian market. GROUP 4 - MS with the strongest opposition - Austria, Greece, Hungary, and Italy In these countries, biotechnology has a negative image in the public opinion, national policies are restrictive, and the industry is not open to the technology. In these MS, the image of plant biotechnology was damaged principally by the binary approach by activists and the industry. The industry was discouraged to produce and use GE products, thus resulting in an official cultivation ban, and little to no research. Austria remains one of the leading forces within the EU against agricultural biotechnology. The Gene Technology Act, its amendments, and pertaining orders
Posted: 14 September 2011, last updated 15 September 2011

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