Agricultural Biotechnology Annual 2012

An Expert's View about Crops and Support Services in Russia

Posted on: 31 Aug 2012

In April 2012, Russia adopted a State Program on the Development of Biotechnology (including agricultural biotechnology) through 2020.

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: 7/19/2012 GAIN Report Number: RS1246 Russian Federation Agricultural Biotechnology Annual Agricultural Biotechnology Annual 2012 Approved By: Levin Flake Prepared By: Yelena Vassilieva Report Highlights: In April 2012, Russia adopted a State Program on the Development of Biotechnology (including agricultural biotechnology) through 2020. The document acknowledges that Russia is lagging behind the rest of the world in this field and envisages adoption of a number of legislative documents that will allow Russia to create a biotech-oriented economy by 2020. Although this Program helps demonstrate that the government is shifting towards a more pro-biotech policy, in the past year there have been no serious changes in actual agricultural biotechnology legislation and a de-facto ban on cultivation remains. Russia continues registration of biotech crops for imports and use in foods and feeds, but still has no mechanism for cultivation approval. Section I. Executive Summary: On April 24, 2012, Russian Government adopted “The Comprehensive Program for Development of Biotechnology in the Russian Federation through 2020” (BIO 2020). This document acknowledges that Russia is lagging behind both the developed and developing countries in the development and use of biotechnology (including agricultural biotechnology) and sets targets to create a biotech oriented economy by 2020. Note: for more information on the Program see GAIN report Program on Development of Biotechnology in Russia through 2020_Moscow_Russian Federation_6-7-2012.doc. The Program seems to demonstrate that the Government is serious about the development and use of agricultural biotechnology in Russia and envisages that in 2012-2014 a number of documents shall be prepared for implementation of the Program. However, most of planned documents concerning agricultural biotechnology are not legal acts but preliminary analyses and reports to the government on improving mechanisms of control of safety of agricultural biotechnology. As was reported last year, in October 2010 Russia adopted a Federal Law that allowed the Government to develop a registration procedure for the cultivation of biotech crops, and by June 2011 the Ministry of Economic Development prepared a draft government resolution on the state registration of genetically modified organisms for release into environment. However, this resolution has not been adopted yet. Moreover, due to the reorganization of the Russian government that followed presidential elections in March 2012, it is not clear what government agency may coordinate the bio-safety approval of biotech crops for cultivation. Since July 2011 there have been almost no changes in the mechanisms that regulate Russian agricultural biotechnology. The registration of biotechnology crops/lines/traits and imported biotech foods and feeds containing these lines have continued. Although imports of products containing biotech ingredients, such as corn and soybeans and their products, have slowed down, this is due more to Russia’s increased domestic production of corn and soybeans than any change in biotech policy. At the same time the de-facto ban on biotech crop cultivation has continued. The anti-GMO public campaign has faded since the beginning of 2012, and even the Moscow city government stopped requiring “Does not contain GMO” labeling. For more information see GAIN report Moscow Government Stops Requiring GMO-Free Labeling of Food Products_Moscow_Russian Federation_5-7-2012.doc. Moreover, the Russian Ministry of Agriculture hosted and volunteered to chair the APEC’s High Level Policy Dialogue on Biotechnology in May 2012 in Kazan’, Tatarstan Republic of the Russian Federation. The discussions in Kazan’ demonstrated Russia’s wiliness to develop its agricultural biotechnology. In July 2012 Russian Government also adopted the State Program on Development of Agriculture through 2020, and biotechnology is among the priorities of technological and innovation policy of the Ministry of Agriculture, although development of biotech crops for cultivation was not specified as one of the priorities. Section II. Plant Biotechnology Trade and Production: De-Facto Ban on Biotech Crop Cultivation Continues Russia does not have an official ban on the cultivation of genetically engineered seeds, however, Russia does not have any mechanism for the approval biotech seeds for release into environment. As a result, according to the Russian Federal Law on Genetic Engineering, without such a mechanism the cultivation of biotech seeds is not allowed. In April 2012 Russia adopted the Comprehensive Program on Development of Biotechnology through 2020 (BIO 2020). The program envisages development of different branches of biotechnology, including agricultural biotechnology, one segment of which is the “development and introduction of genetically modified plants in agriculture”. Although the program does demonstrate that the Government seems to recognize the importance of Russia developing agricultural biotechnology, the Program does not yet propose mechanisms for this development. Moreover, the draft government resolution that was prepared by the Ministry of Economic Development in spring 2011 (for more information see GAIN report Agricultural Biotechnology Annual_Moscow_Russian Federation_7-7- 2011.doc ) and authorized the Federal Veterinary and Phytosanitary Surveillance Service (VPSS) at the Ministry of Agriculture to conduct registration of biotech crops for release into environment has not been adopted. Moreover, due to the reorganization of the Russian government that followed presidential elections in March 2012, the authorities and functions of different agencies have changed, and it is still not clear what government agency would coordinate the bio-safety approval of biotech crops for cultivation. The role of the inter-agency commission on biotechnology, which nominally existed at the Ministry of Education and Science in 2003- 2012, is not clear. The new Program on Development of biotechnology is monitored by the Ministry of Economic Development, but this Ministry does not have authority for bio-safety approval. Russian scientists have continued some laboratory research on biotech agricultural crops, but the research has not yet reached the stage of field trials. Although field trials are not prohibited, they need a special permission from the Variety Testing Commission at the Ministry of Agriculture which companies report is no longer granted. The Commission is responsible for tests of any variety; even for small-scale field trials for research purposes. The adoption of the program BIO 2020 fanned expectations of Russian scientists in the field of biotechnology. Since more and more agricultural producers express interest in biotech crops, especially drought resistant crops and crops that can be used in minimum and no-till farming, many scientists feel that there is a large potential market in Russia for these crops, but they cannot increase research and begin commercializing the crops they develop until Russia implements a mechanism for approval of biotech crops for cultivation. Status of Product Approval for Imports and Food and Feed Use Russia registers biotech crop/lines for food use for an unlimited period while the registration of biotech crops/lines for feed use is given only for 5 years, and it is necessary to re-register them every 5 years. Since July 2011, Russia has not registered any new biotech crops/lines for food use, but for feed use has re-registered Corn BT 11 and registered Corn MIR 162 for the first time. Corn BT 11 tolerant to gluphosinate and resistant to corn borer Ostrinia nubilalis (Syngenta) was originally registered for feed use for Dec. 2006 – Dec. 2011, and was re-registered for December 2011 – December 2016. Corn MIR 162, resistant to Lepidoptera pest (Syngenta) was approved for feed use and registered for the first time for March 2012 - March 2017. For food use it was approved in April 2011 for an unlimited period. Since the beginning of registration of biotech lines for food use in 1999 Russia has approved and registered 21 lines of genetically engineered crops. However, 3 lines - Sugar beet, line GTSB77, resistant to gliphosate, Potato RBBT02-06, resistant to Colorado beetle, and Potato SPBT02-5, resistant to Colorado beetle - were not re-registered because of the closure of the projects. Thus, as of May 15, 2012, Russia has 18 lines of biotech crops that can be legally imported to Russia for food use. These are ten lines of corn, four soybean lines, one sugar beet line, one rice line, and two lines of potato. Of these 18 crops, 14 are also registered for feed use, including 10 lines of corn and 4 lines of soybeans. The list of registered crops is in the Table 1. Monsanto, Bayer and Syngenta were the only three companies to have their biotech crops registered in Russia. One registered sugar beet variety belongs to Monsanto and KWS. Since 2007 food registration is given for unlimited period; however, the certificate of registration can be recalled if negative incidents occur. Feed registrations are granted for five years. Table 1. Russia: Approved and Registered Biotech Crops, 1999-2012 Crop/line/event/trait Applicant Year and period of Registration For Food Use For Feed Use 1 Bt corn MON 810, resistant to Monsanto 2000 – 2003, 2003 – 2008 European corn borer Ostrinia 2003 – 2008 Sep. 2008 – nubilalis Mar. 2009 – Aug. 2013 for unlimited period 2 Roundup Ready® corn NK 603, Monsanto 2002 – 2007; 2003 – 2008 tolerant to glyphosate Feb. 2008 – Sep. 2008 – for unlimited Aug. 2013 period 3 Bt corn MON 863, resistant to corn Monsanto 2003 – 2008 2003 – 2008 root worm (Diabrotica spp.) Aug. 2008 – Sept. 2008 – for unlimited Aug. 2013 period 4 Corn Bt 11, tolerant to Syngenta 2003 – 2008 Dec. 2006 – gluphosinate and resistant to corn Sep. 2008 – Dec. 2011, borer Ostrinia nubilalis for unlimited Dec. 2011 – period Dec. 2016 5 LL Corn T25, tolerant to Bayer Crop 2001 – 2006, Dec. 2006 – gluphosinate Sciences Feb. 2007 – Dec. 2011; for unlimited Since 2011 period under review for extension 6 Roundup Ready ® corn GA 21, Syngenta 2007 – for Nov. 2007 – tolerant to glyphosate* unlimited Nov. 2012; period Since May 2012 under review for extension 7 Corn MIR 604, resistant to corn Syngenta 2007 – for May 2008 – root worm (Diabrotica spp.) unlimited May 2013 period 8 Corn 3272 with α-amylase enzyme Syngenta April 2010 – Oct. 2010 – to break starch during ethanol for unlimited Oct. 2015 production period 9 Corn MON 88017 (CCR), tolerant Monsanto May 2007 – Sep. 2008 – to glyphosate and resistant to corn for unlimited Aug. 2013 root worm (Diabrotica spp.) period 10 Corn MIR162, resistant to Broad Syngenta April 2011 - March 1212 – Lepidoptera spp. for unlimited March 2017 period 11 Roundup Ready® soybeans 40-3-2, Monsanto 1999 – 2002, 2003 – 2008, tolerant to glyphosate 2002 – 2007, May 2008 – Dec. 2007 - May 2013 for unlimited period 12 Liberty Link® Soybeans A2704- Bayer Crop 2002 – 2007 Nov. 2007 – 12, tolerant to gluphosinate Sciences 2008 – for Nov. 2012 unlimited period 13 Liberty Link® Soybeans A5547- Bayer Crop 2002 – 2007 Nov. 2007 – 127, tolerant to gluphosinate Sciences Feb. 2008 – Nov. 2012 ammonium for unlimited period 14 Soybean MON 89788 (RRS2Y), Monsanto Jan. 2010 – May 2010 – tolerant to glyphosate + yield gain for unlimited May 2015 period 15 Rice LL62, Bayer Crop 2003 – 2008 tolerant to gluphosinate ammonium Sciences Jan. 2009 – for unlimited period 16 Roundup Ready ® Sugar beet H7- Monsanto/KWS May 2006 – 1, tolerant to glyphosate for unlimited period 17 Bt potato “Elizaveta” (resistant to Center “Bio- Dec. 2005 – Colorado potato beetle) engineering”, for unlimited Russia period* 18 Bt potato “Lugovskoy” (resistant to Center “Bio- Jul. 2006 – Colorado potato beetle) engineering”, for unlimited Russia period Four crops are waiting for approval, including a variety of Monsanto corn for food and for feed use, Monsanto soybeans for food use, BASF soybeans for food and for feed use, and Syngenta corn for food and for feed use (Table 2). It is expected that one new corn line will be submitted for approval in the end of 2012 – beginning 2013. Table 2. Russia: Biotech Crops Awaiting Approval Crop/line/event/trait Applicant Date of Submission for Approval For Food Use For Feed Use 1 Corn MON 89034, resistant Monsanto Under review, Under review, to Lepidoptera pest submitted for submitted for registration in March registration in May 2010 2012 2 Bt soybeans, MON 87701, Monsanto Under review, re- Submitted for resistant to Lepidoptera pests submitted for registration in July registration in June 2012 2012 3 Soybeans BPS-CV-127-9, BASF Under review, Under review, imidazolinone submitted in March submitted in 2011 September 2011 4 Corn 5307, resistant to corn Singenta Under review, Under review, root worm (Diabrotica II) submitted in June 2012 submitted in June 2012 Crop that are planned to be submitted later in 2012 – beginning of 2013 5 Corn Mon 87460, Draught Monsanto Planned for submission Planned for Single in Nov. 2012 submission in Nov. 2012 About 140 lines of biotech crops are registered for food and feed use in the world, but only 18 lines are registered in Russia. Besides registration of crops/lines/events, Russia requires that each biotech food product, ingredient, and each feed containing biotech event is registered separately. The registration can be given only on the basis of the already registered event. For food the requirement to register products containing biotech (GMO) ingredients is based on the FLs “On Sanitary-epidemiological Well-Being of Population”, “On Quality and Safety of Food Products”, and the GOR Resolution “On the State Registration of New Food Products, Materials and Goods” #988 of December 21, 2000. From 2004 by July 1, 2010 (the date of coming to force of the Customs Union of Russia, Kazakhstan and Belarus - CU) Rospotrebnadzor, the agency responsible for biotech registration for food use, registered 67 products derived from genetically modified organisms (GMO) and microorganisms (GMM), including 20 products on the bases of GMO (9 varieties of corn, 2 varieties of potato, 4 varieties of soybeans, 1 variety of sugar beet, 1 variety of rice, and 3 biologically active additives – BADs), and 47 products on the bases of GMM. In accord with coming into force of the CU Agreement on sanitary measures, since July 1, 2010, Rospotrebnadzor is registering food products produced on the basis of or with use of GMO and/or GMM (per Part II of the Unified List of Products Subject to sanitary-epidemiological surveillance on the customs territory and customs border of the CU, Decision of the CU Commission #299 of May 28, 2010.) In the framework of the CU the Rospotrebnadzor registered 44 such products, including 19 products derived from GMOs (19 varieties of corn, 5 varieties of soybeans, 1 sugar beet variety, 1 rice variety, and 2 BADs), and 25 products derived from GMM. Of these 44 products the GMO corn line MIR162, resistant to pest, and soybeans line 40-3-2, gliphosate tolerant were registered for the first time. The other 42 products had been examined before in Rospoterebnadzor, and the certificates were just re-issued for the Customs Union. For feeds registration, since 2002 the Federal Veterinary and Phytosanitary Surveillance Service (VPSS), the agency responsible for registration of biotech crops/lines for feed use and biotech feeds, registered 213 names of feeds containing GMO, and 13 GMO crops/lines/traits, including 4 soybean lines and 9 lines of corn. VPSS registers feeds and additives only for 5 years, and in 2002 – 2012 some registrations expired and were not renewed and at present there are 127 registered feed additives and lines registered for feed use (on the VPSS web-site). VPSS, continued registration only for Russia. It is still not clear, when and how VPSS is planning to begin issuing certificates for biotech feed products valid on the territory of the whole Customs Union. Trade Russian customs data does not separate genetically engineered products from the non-GMO products. However, most of corn and soybeans imported into Russia, as well as products produced from corn and soybeans, may contain genetically engineered crops. In accordance with the Russian legislation the imported product is considered non-GM if the presence of GMO does not exceed levels determined by the Russian legislation: not more than 0.9 percent of registered or non-registered GMO lines in food products or ingredients, not more than 0.9 percent of registered GMO lines in feed ingredients, and mot more than 0.5 percent of non-registered GMO lines in feed ingredients (for more information see section Plant Biotechnology Policy of the present report). Russia continues to increase its poultry and swine production, and this production is more and more concentrated at large poultry and swine farms that use primarily compound feeds in the feeding rations. Despite increased domestic production of protein and high energy feeds such as soybeans and corn, Russia continues imports of soybeans, corn, and products processed from these crops. Given that the Customs data for June 2012 is not available, Table 3 shows yearly imports from June through May in the period 2008 – 2012. Due to increased domestic production of soybeans and the bumper corn crop in Russia in 2011, imports of these crops slowed down in 2011/2012. Thus imports of corn dropped by more than half to 44,261 metric tons (MT), imports of corn groats and meal decreased by 22 percent to 17,214 MT, imports of soybeans decreased by 22 percent to 798,742 MT. However, imports of processed products, such as corn starch and soybean meal increased. Since prices of imported products in 2011/2012 were higher than a year ago, the total value of imported products that may contain biotech ingredients was only slightly less than $1 billion, and was higher than in 2008/09 and 2009/10. However, the share of U.S. products remains small – only $22 million, and decreased from the previous year. Although weakening, the anti-GMO attitude of Russian consumers can still influence imports of corn and soybean and their products, especially soybeans and soybean products. In general, feed trade does not reflect a pro- or anti-biotech attitude, but rather domestic demand in corn and soybeans. However, some regions in the south of European Russia, including major meat producers, such as Belgorod oblast and Krasnodar kray, declared themselves GMO-free-zones and buy only non-GMO feeds. In order to meet the demand in feeds in these oblasts, Russia’s major soybean crushing company, Sodruzhestvo, does maintain separate facilities for GM and non-GM soybeans in Kaliningrad. For food and food ingredients, the anti-GMO campaign in Russia faded in 2011/2012, and in spring 2012 the Moscow city government ceased requiring testing food products for presence of GMO and “Non-GMO” labeling of food products. However, the anti-GMO campaign had already affected food processors’ decisions and importers of these commodities report that in 2011-2012 food processors and traders still preferred certified no-biotech products in order to meet consumers’ preferences. According to Russian nutrition specialists, the refusal to use registered and approved plant proteins, including soybean proteins, in the food industry (sausages, and other products resulted in the decrease of nutrition value of Russian food products (in protein) by 20 percent since 2006. Additionally, certified non-GMO imports of soybeans and corn do not always reflect the real situation. The leaders in soybean supply to Russia are Paraguay and Brazil (63 percent and 26 percent of Russia’s imports in 2011/2012 respectively), and leaders in soybean meal supply to Russia are Argentina (56 percent of Russian’s imports). In these countries the overwhelming majority of soybeans are GMO, and the separation of non-GMO and GM soybeans at the stage of handling and processing is not always very accurate. Table 3. Russia: Imports of products that may contain biotech ingredients, June May, 2009 – 2012 2008/09 2009/10 2010/11 2011/12 Metric Tons Corn (1005) 246,570 43,548 101,071 44,261 - from the U.S. 2,790 2,308 3,402 4,969 Corn Groats and Meal (1103 13) 27,849 25,056 22,120 17,214 - from the U.S. 0 0 2 0 Corn Starch (1108 12) 17,065 7,803 10,035 12,306 - from the U.S. 1 0 73 253 Soybeans (1201) 680,712 1,027,999 1,025,652 798,742 - from the U.S. 25,909 95,968 26,788 30,250 Soybean flour (1208 10) 5,678 2,089 1,651 1,248 - from the U.S. - - - - Soybean Meal (2304) 586,950 399,219 455,142 583,237 - from the U.S. 18,422 52,160 46,023 1,646 Soybean Isolates (from 3504) Total group 3504 42,594 46,333 49,620 53,595 - from the U.S. 977 209 559 362 1,000 US Dollars Corn (1005) 136,521 51,112 96,017 101,357 - from the U.S. 2,102 1,550 2,428 4,194 Corn Groats and Meal (1103 13) 10,642 7,285 8,134 7,165 - from the U.S. 0 0 6 0 Corn Starch (1108 12) 7,428 2,899 6,068 7,966 - from the U.S. 6 0 90 319 Soybeans 341,515 480,150 521,271 431,700 - from the U.S. 10,208 42,497 15,836 15,064 Soybean flour (1208 10) 3,665 1,499 1,380 1,152 - from the U.S. - - - - Soybean Meal (2304) 323,844 198,337 213,405 269,802 - from the U.S. 9,246 23,186 20,938 918 Soybean Isolates (from 3504) Total group 3504 80,085 108,116 114,410 134,995 - from the U.S. 3,065 811 1,726 1,288 Total all products 903,699 849,398 960,685 954,138 - from the U.S. 24,627 68,044 41,024 21,784 Source: Global Trade Atlas Section III. Plant Biotechnology Policy: Russian Biotechnology Legislation As of July 2012, Russian legislation in the sphere of agricultural and food biotechnology still does not contain a comprehensive harmonized code of laws. Federal laws, government resolutions and orders of the Chief Sanitary Doctor (Head of the Federal Service for Surveillance in the Sphere of Human Rights Protection ad Human Well-Being - Rospotrebnadzor) listed below regulate Russian biotech policy at present. These include laws on product registration and consumer information about biotech ingredients in food products. Since Russia became a member of the Customs Union (now Euro-Asian Economic Commission – EvrAzEs) its trade legislation is subordinated to the legislation of the Customs Union. As of July 2012 the Customs Union has adopted several technical regulations (TRs) that concern agricultural biotechnology and consumer labeling, but these adopted TRs will come to force only on July 1, 2013. These are the following TRs of the Customs Union: TR on Food Safety, TR on Food Labeling, and TR on Safety of Grain. Another Custom Union’s TR that will be important from the point of view of imports and turnover of biotech feeds is the TR on Feeds Safety. However, this TR is still under discussion. Summary of acting Russian laws and regulations that influence agricultural biotechnology: Federal laws Federal Law No. 86-FZ of June 5, 1996, On the State Regulation in the Sphere of Genetic Engineering Activities” with amendments made in 2000 and in 2010. This is a foundational federal law on genetic engineering in Russia, but the law does not determine instruments for implementation. In 2010 the amendment to this FL authorized the Government to develop and adopt procedures for the release of the genetically modified organisms into environment (Federal Law No 262-FZ of October 4, 2010, On Amendments to the Federal Law “On the State Regulation in the Field of Genetic Engineering”.) However, by July 2012 the government did not issue any regulatory document concerning release of biotech crops into the environment; Federal Law No 52-FZ of March 30, 1999, On the Sanitary-Epidemiological Well-being of the Population; Federal Law No. 29-FZ of January 2, 2000, On the Quality and Safety of Food Products with amendments made in 2001 – 2008; Federal Law No. 2300-1 of February 7, 1992, On the Protection of Consumers Rights with amendments. The amendment of October 25, 2007 sets the threshold for mandatory labeling of food ingredients made from biotech material to 0.9 percent. Prior to this amendment, trace amounts of biotech food ingredients required labeling; The Federal Law No. 7-FZ of January 10, 2002, On Environmental Protection, as amended by January 1, 2011. Article 50.1 Environmental Protection from Negative Biological Impact of Federal Law No. 7-FZ of January 10, 2002. The Article sais: “it is prohibited to produce, grow and use plants, animals and other organisms not typical for natural ecological systems, or created artificially, without developing effective measures to prevent their uncontrolled reproduction, obtaining a positive state ecological expert’s conclusion, and permission from the federal bodies of executive power that conduct the state management of environment, and other federal bodies of executive power in accordance with their competence and legislature of the Russian Federation”. Federal Law “Technical Regulation on Milk and Dairy Products” (FL #88 of June 6, 2008). This TR sets some limitations on use of soybean proteins in some dairy products; Federal Law “Technical Regulation on Oil and Fat Products” (FL #90 of June 24, 2008. This TR requires labeling of oil and fat products for human consumption, and labels shall include information on the presence of GMO; Federal Law “Technical Regulation on Fruit and Vegetable Juices and Their Products” FL #178 of October 27, 2009. This TR bans use of GMO in baby food (fruit and vegetable juice products for babies) and requires state registration of any products that was processed using methods of genetic modification. Resolutions of the Russian Government Resolution of the Government of the Russian Federation No. 988 of December 21, 2000, On State Registration of New Food Products, Materials, and Goods with amendments. The resolution authorizes registration of GMO food Resolution of the Government of the Russian Federation No. 120 of February 16, 2001, On State Registration of Genetically Modified Organisms and Registration Regulation. This Resolution enforced the state registration of GMO organisms; Resolution of the Government of the Russian Federation No 26 of January 18, 2002, On the State Registration of GMO Feeds; Resolution of the Government of the Russian Federation No. 422 of July 14, 2006 that transferred testing and registration of biotech feeds from the Ministry of Agriculture of the Russian Federation to the Federal Service for Veterinary and Phytosanitary Surveillance (VPSS). Normative acts of government bodies Resolution of the Chief Sanitary Doctor of the Russian Federation (No 14 of November 8, 2011), On the Procedure of Sanitary-Epidemiological Expertise of Food Products from Genetically Modified Sources; Hygienic Requirements for Safety and Nutrition Value of Food Products. These norms, SanPiNs, are developed and approved by the Rospotrebnadzor; Methodological directives on norms and methods for testing, identification and analyses of genetically modified foods, organisms and microorganisms. State standards for food products. These methods and standards may be developed by different organizations, but usually approved by Federal Agency on Technical regulation and Metrology of the Ministry of Industry and Trade of the Russian Federation. Decisions of the Customs Union The Customs Union came to force in July 2010, and development and adoption of all not-yet adopted Russian technical regulations (TRs) was suspended, and experts began developing new technical regulations for the whole Customs Union. Since then Customs Union has adopted several TRs that will mostly influence agricultural biotechnology: CU TR No 021/2011 on Safety of Food Products (adopted in December 2011, comes to force on July 1, 2013). This TR stipulates that food products can be processed only from GMO/GMM registered in the CU. If the producer did not use GMO at processing of food products, the presence of 0.9 percent and less of GMO is considered an adventitious, unavoidable presence, and products are not GM. The TR also bans use of GMO in baby food and in food for pregnant and nursing women; CU TR No 022/2011 on Food Labeling (adopted in December 2011 and comes to force on July 1, 2013). This TR requires that food products with GMO shall be labeled, and determines the format of this labeling. Presence of 0.9 percent and less GMO shall not be labeled, and the product is not considered GM product. Labeling of food products as non-GMO is voluntary and absence of GMO shall be proved and documented; CU TR No 015/2001 on the Safety of Grain (adopted in December 2011, comes to force on July 1, 2013). The TR determines requirements to information on grain /oilseeds during transportation either in bulk of in consumer packs (for feed purposes). The information includes information on GMO if presence of GMO is higher than 0.9 percent. Besides, in the sanitary requirements for grain/oilseeds (MRLs of toxic elements, micotoxins, pesticides, radionuclide and pests) the TR stipulates that grain/oilseeds (both for food and for feed use) may contain only registered GMO lines (registered in accordance with the legislation of the states, members of the CU), and in the GM grain presence of non-registered lines shall not exceed 0.9 percent. The CU TR on the Safety of Feeds is still under discussion, and has not been adopted. Recent activities Recently the Russian government initiated some activities aimed at development of biotechnology in Russia within the framework policy of Russia’s modernization and innovation: On April 24, 2012 the Russian Government adopted the Comprehensive Program on Development of Biotechnology through 2020 (See GAIN Report); the Russian Ministry of Agriculture headed the APEC’s annual High Level Policy Dialogue on Agricultural Biotechnology in Russia in May 2012; The Committee on Science in the Russian Duma (senior legislative body of the Russian Federation) in June 2012 held a special hearing on development of comprehensive legislation in the sphere of agricultural and food biotechnology. Government Ministries and Their Roles The Russian Government is in the process of reorganization after the March 2012 Presidential elections and this reorganization may cause some changes in the system of registration of biotech lines and products. Thus, beginning June 2012 Rospotrebnadzor is subordinated directly to the Russian Government/Prime Minister, while before it was under the Ministry of Health and Social Development. Given that currently Rospotrebnadzor supports the development of biotechnology and the use of science-based biotech achievements, its increased authorities may stimulate the use of biotechnology in medicine and in food production. The role of different Russian ministries, and government services and agencies: 1. Before mid-June 2012, the Ministry of Health and Social development (beginning June 2012 – Ministry of Health) - developed legislation to protect human health and environment from negative effect of GMO; - developed and approved the list of regulated (subject to registration) GM products, developed regulations for registration of GMO, provided information on registered GMO food products, approved forms of application for registration and forms of certificates of registration of GMO products. All these functions may be transferred to Rospotrebnadzor after it gained independence from the Ministry of Health in June 2012; 2. Rospotrebnadzor (prior to June 19, 2012) - conducted survey and control of turnover of GM food products in order to provide for the sanitary-epidemiological well-being of population and protection of consumer rights in accord with the Russian legislation; - conducted the state registration of new food products containing GMO, including those that are imported to Russian for the first time; - kept the state register of GM food products allowed for sales, production and imports on the territory of the Russian Federation; Since the unified economic environment within the Customs Union started working on January 1, 2012, the valid certificates and permits on the use of biotech food and biotech food ingredients are those that were issued for circulation on the territory of the Customs Union. Rospotrebnadzor has re-registering old certificates for the whole Customs Union by the end of 2011, and since 2011 issues new certificates for the whole Customs Union. From June 2012 Rospotrebnadzor will retain all these functions and also will be responsible for development of legislation on GM food products. 3. Ministry of Agriculture of the Russian Federation - overall legal regulation in the sphere of veterinary and phytosanitary well-being of Russia aimed at mitigation of negative effect of GMO on agricultural animals, plants, and environment, agricultural raw products, processed food products; - conducts the state register of feeds from GMOs; 4. Federal Service for Veterinary and Phytosanitary Surveillance (VPSS) subordinated to the Ministry of Agriculture: - surveys the safety of feeds and feed additives derived from GMO at all stages of production and turnover; - state registration of feeds derived from GMO; - issues certificates of registration for GM feeds; 5. Ministry of Industry and Trade participates in the development of national standards and technical regulations which set requirements for biological safety of regulated items. This Ministry participates in development of technical regulations of the Customs Union; 6. Ministry of Economic Development beginning 2012 will monitor the implementation of the Comprehensive Program on Development of Biotechnology in the Russian Federation through 2020. Biotech Food Labeling Requirements In accordance with the current Russian legislation, which will be in force in Russia before the CU TRs on Food Safety and Food Labeling come to force on July 1, 2013, all organizations that import, produce, or trade food products to/in Russia must inform consumers about the presence of biotech components in food products if each individual biotech event does not exceed 0.9 percent. Rospotrebnadzor’s Order No. 80 specifies the methods that should be used to test for biotech presence in food. For imported food products Rospotrebnadzor has the right to conduct sample tests to detect the presence of biotech components. In order to verify the biotech-free claim the producer or exporter may conduct its own tests at independent laboratories (it may be an IP system, PCR test), but the results of these tests are not accepted by the Russian Rospotrebnadzor. These pre-export tests are voluntary for producers and exporters. If a producer/exporter claims that its products are not genetically altered, Rospotrebnadzor still has the right to examine these products. Furthermore, if the presence of genetic alteration in the products is more than 0.9 percent, a claim for fraud may be placed on that company. Usually Rospotrebnadzor pays special attention to products containing soybean or corn ingredients. Labeling Requirements for Feeds. The information on composition of feeds, including presence of biotech components is in the shipping documents, but so far Russia has not required labeling of presence of GMO in feeds on consumer packs of feeds. Registration for Food Use The Russian Federal Rospotrebnadzor registers biotech crops and ingredients for food use. The registration process remains the same as last year: The applicant submits the application and dossier to Rospotrebnadzor; Rospotrebnadzor assigns a safety assessment to the Institute of Nutrition of the Academy of Medical Sciences; The applicant concludes an agreement for the food safety assessment with this Institute; and On the basis of the Institute’s assessment, Rospotrebnadzor issues a certificate of registration and registers the product. It takes 12 months to conduct laboratory tests required for the safety assessment and an additional two to three months to organize and prepare documents for the new biotech crops. Registering food products and ingredients requires less time, however, registration is only granted if the biotech product contains biotech events that have already been registered. It is necessary to provide a copy of the event registration certificate in the application documents when registering food products or ingredients. Only those companies with registered crops in Russia for food use (one of three companies mentioned above) can provide a copy of the crop registration certificate. Since 2006 Rospotrebnadzor has registered food-use crops for an unlimited time period. Information on biotech crops registered for food use for food products or an ingredient containing registered biotech ingredients is available on Rospotrebnadzor’s website: The list of registered products contains all new food products, not only biotech products or products with biotech ingredients. There are several hundred different products and names. To find permitted food products for a specific crop, search for the name of the crop and the words “genetically modified.” The institutes that conduct biotech crop and food product research remain the same as last year, namely: Russian Academy of Medical Sciences - Institute of Nutrition and Food Safety Assessment (medical and biological studies), the Russia Academy of Sciences for Bioengineering of (genetic studies), and the Moscow State University of Applied Biotechnology (technological assessment). Registration for Feed Use Plant-origin feed imports require a veterinary certificate and a letter stating that the feed is biotech free. Feed may be classified as biotech-free if presence of each non-registered biotech line in feeds does not exceed 0.5 percent and if the presence of each registered biotech line in the feed does not exceed 0.9 percent. In this case, “registered” refers to products registered in Russia and “non-registered” refers to products not registered in Russia. The presence of genetic alterations in feed components is calculated separately and not comprehensively. For example, if two registered components in feeds contain 0.6 percent of genetic alterations in each, then the feed is considered to be non biotech, although together the sum is 1.2 percent. The pre-export identification of feed as non-GMO is not required. It is up to the producer/exporter to declare the feed as non-GMO, but the VPSS regardless examines the products for the presence of biotech components. If the feed contains biotech ingredients, and is not declared as biotech free, the shipment must include a copy of the certificate indicating that the biotech components in the feed are registered with the Federal Service for Veterinary and Phytosanitary Surveillance (VPSS). The imports must also have a phytosanitary quarantine certificate, although it is unrelated to biotechnology. Any biotech components in feed must be appropriately registered. Presence of each non-registered biotech lines shall not exceed 0.5 percent. The Custom Union’s TR on Feeds has not been adopted yet, but the adopted TR on Safety of Grain stipulate that feed grain/oilseeds is considered non GMO if the presence of each non-registered biotech lines does not exceed 0.9 percent. The TR on Safety of Grain came into to force on July 1, 2012. The responsibilities of VPSS in feed registration was confirmed by the Order of the Russian Ministry of Agriculture No. 466 of October 6, 2009 that approved the registration regulations. The Regulation states that the registration is issued for 5 years. The regulation covers “products of plant, animal and microbiological origin, and their components, used for feeding animals, and which contain animal health non-harmful digestible nutrients.” The Regulation does not allow the registration of several types of GM feeds under one name, or to register the same GM feed several times under one or under several different names. The applicant must submit the following documents: 1. application for the state registration of GM feed; 2. materials that contain information on the following - information on the origin of GM feed, - evaluation of the potential danger of use of GM feed (compared with the initial basic feed), and recommendation of the applicant on the risk reduction, - information on the supposed use of the GM feed, and on the registration and the use of this feed abroad, - information about the technology of growing the modified variety of the plant that is used for production of GM feed, - data on the technology of production of GM feed, - draft of the instruction on the use of GM feed 3. if the modified plant variety, which is used for feed is viable and is meant for biomass or fodder growing, the certificate from the Russian State Register of Selection Achievements must be attached . All documents shall be in Russian or shall have the certified translation into Russian. Copies of document shall be certified by a notary. VPSS will make a decision on the registration of a GMO feed based on the Conclusion of the Experts Council on the safety (non-safety) of the GMO feed. The procedure and necessary documents for registration of feed containing GMO is on the VPSS’s web-site: To register formula feeds, VPSS issues feed-registration certificates to a specific applicant for an individual shipment during a certain period of time. VPSS only issues certificates for feeds produced using registered biotech crops. The certificates cannot be transferred to different importers. This registration is conducted by VPSS. The list of registered GMO containing feeds/feed additives and GMO traits/lines containing contain 127 titles and available on the VPSS’s site: It includes registered lines (see table 1). The research of crops for feed use and the research of biotech formula feeds is conducted by the Federal State Organization “All-Russian Center of Quality and Standardization of Animal Pharmaceuticals and Feeds – VGNKI, subordinated to VPSS. Fees for registration of biotech events: Rospotrebnadzor’s charges for all examinations and related services, including comprehensive studies required to register for food use biotech events. The fee varies, depending on the range of examinations and studies, but averages around $100,000 for the approval of new events for an unlimited period. The option to register for an unlimited period began in 2006. The fee for re-examination and re-approval of events that were registered before 2006 is approximately $10,000. Registration of food products that contain a previously registered biotech event is 20,000 rubles ($645). For registration of biotech events for feed use, VPSS usually registers events only after it has been approved for food use. However, the registration fee is usually higher and the process is more cumbersome. The registration fee is not fixed, and depends on the range of examination and studies, In average the charge for examination and a 5 year event registration for feed use is approximately $100,000. The charge is the same for registration for the first time and for re-registration every five years. Companies that import formula feeds with registered biotech components also need to register these feeds as biotech feeds. The registration is given the company that imports this feed and VPSS requires that each feed that contains a registered GM event also be registered. Section IV. Plant Biotechnology Marketing Issues: Labeling requirements increases the price of food containing biotech ingredients. The price of examining products for the presence (or absence) of biotech components is high because the approved methods of testing are extensive. It is rare to find a GMO label, though non-GMO label can commonly be seen on dairy, eggs and poultry products. Since the Moscow city government stopped requiring non- GMO labeling, many food processors in Moscow will discontinue these special tests, and less products will be sold with the special “Does not contain GMO” label. Section V. Plant Biotechnology Capacity Building and Outreach: By the spring of 2012 the activities of anti-biotech groups decreased and consequently the anti-biotech campaign has faded. However, anti-GMO publications again emerged in early summer 2012 on the eve of Russia’s ratification of WTO accession. The penetration of agricultural biotechnology to Russia is presented not only as a threat for public health, but as a threat to Russia’s domestic agricultural production. The pro-biotech groups have not received new funds in spite of a declared support of innovations and advanced technologies by the Russian Government. The new program BIO 2020 envisages government advocacy of positive aspects and advantages of biotechnology, including agricultural biotechnology, but does not envisage any special funding for these activities. Russian scientists understand the necessity to monitor biotechnology at the international level, including through measures envisaged by the Cartagena Protocol. However, Russia is the only member of the Customs Union that has not ratified this Protocol. Both Belarus and Kazakhstan have ratified it. Some Russian scientists have opinion that the delay in ratification of Cartagena Protocol may leave Russia without the world-wide acknowledged mechanism to defend its own national policy in the field of biotechnology after the WTO accession. Section VI. Animal Biotechnology: This is only at the stage of some limited laboratory research, but information is very limited.
Posted: 31 August 2012

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