Russia. Agricultural Biotechnology Annual. Jul 2013 Nov. 6, 2013
Russia continues registration of Genetically Engineered (GE) crops for imports of food and feeds, but does not have legislation or a mechanism covering approval of GE crops for cultivation. Thus, a de-facto ban on cultivation is still in force. The draft of the government resolution that allows registration of GE crops for release into the environment (and cultivation) has not been adopted by the government. The Ministry of Agriculture, the main body responsible for any registration of GE crops for release into the environment, has been conservative on this issue. As for labeling and information for consumers, several technical regulations of the Customs Union (CU) on product safety came to force on July 1, 2013. These regulations confirm that in the CU member states labeling of the presence of over 0.9 percent of GE lines in food products is mandatory.
SECTION I. EXECUTIVE SUMMARY:
Since July 2012, there have been almost no changes in the legislation and mechanisms that regulate Russian agricultural biotechnology. In October 2010, Russia adopted a Federal Law that allowed the federal government to develop a registration procedure for the cultivation of biotech crops via a Resolution of the Government. In June 2011, the Ministry of Economic Development prepared a draft government resolution “On the State Registration of Genetically Modified Organisms for Release into the Environment.” The draft authorized the Federal Veterinary and Phytosanitary Surveillance Service (VPSS) at the Ministry of Agriculture to conduct registration of GE crops for release into the environment (cultivation). In May 2012, the draft was updated by the Russian Ministry of Economic Development and the Russian Ministry of Science and Education, and it reaffirmed that when the final rule is adopted, the registration of feeds, feed additives for animals and GE crops for cultivation will be the function of VPSS. However, this draft, with some amendments, remains in circulation without indicators of its passage in the near future. Moreover, the Ministry of Agriculture, the main body responsible for any registration of GE crops for release into the environment, has been conservative on this issue. Thus, the Russian Federation’s de-facto ban on the cultivation of genetically engineered crops has continued.
On April 24, 2012, the Russian Government adopted “The Comprehensive Program for Development of Biotechnology in the Russian Federation through 2020” (BIO 2020). (for more information see GAIN report Program on Development of Biotechnology in Russia through 2020). This Program BIO 2020 authorized different Russian Ministries to develop biotechnology in their appropriate spheres; including development of different branches of biotechnology, including agricultural biotechnology, one segment of which is the “development and introduction of genetically modified plants in agriculture.” Following the adoption of BIO 2020 on April 24th 2012, the Ministry of Agriculture included “development of biotechnology” in its “Program for Development of Agriculture in 2013”. However, this was for the development of plant protection and not for development of GE crops.
The registration of GE crops/lines/traits for imports for food and feeds has continued. Although imports of products containing biotech ingredients, such as corn and soybeans and their by-products, have slowed down, this is due more to Russia’s increased domestic production of corn and soybeans rather than due to any change in biotech policy.
(Note: All Russian legislative and regulatory documents use the term GMO (genetically modified organisms) or GMM (genetically modified microorganisms) instead of genetically engineered (GE) organisms/microorganisms.)
SECTION II: PLANT AND ANIMAL BIOTECHNOLOGY
CHAPTER 1: PLANT BIOTECHNOLOGY
PART A: PRODUCTION AND TRADE:
a) PRODUCT DEVELOPMENT: In Russia, the de-facto ban on genetically engineered (GE) crop cultivation continues. Although Russia does not have an official ban on the cultivation of GE seeds, it also does not have a mechanism for their approval for release into the environment. As a result, according to the Russian Federal Law on Genetic Engineering, without such a mechanism the cultivation of GE seeds and crops is not allowed.
In April 2012, Russia adopted the Comprehensive Program on Development of Biotechnology through 2020 (BIO 2020). The program BIO 2020 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.” However, BIO 2020 did not propose mechanisms for this development. In accordance with the Federal Law of October 2010 that allowed the government to develop a registration procedure for the cultivation of GE crops, the Ministry of Economic Development prepared a draft government resolution “On the State Registration of Genetically Modified Organisms for Release into the Environment.” The draft authorized the Federal Veterinary and Phytosanitary Surveillance Service (VPSS) at the Ministry of Agriculture to conduct registration of GE crops for release into the environment (cultivation). In May 2012, the draft was updated by the Russian Ministry of Economic Development and the Russian Ministry of Science and Education. This draft reaffirmed that the registration of feeds, feed additives for animals, GE crops for cultivation would be done by VPSS. However, this draft, with some later amendments, is still in circulation in the channels of federal administrative bodies without indicators of its passage in the near future. Thus, the de-facto ban on the cultivation of genetically engineered crops has remained in place.
Russian scientists have continued some laboratory research on GE crops, but the research has not yet reached the stage of field trials. Although field trials are not prohibited, they need special permission from the Variety Testing Commission at the Ministry of Agriculture, which some companies report, is no longer granted. The Commission is responsible for tests of any seed 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. Also, since more and more agricultural producers have expressed an interest in GE crops, especially drought-resistant crops and crops that are better suited to minimum and no-till farming, many scientists feel that there is a large potential market in Russia for these crops. Despite this demand, scientists report that they cannot increase research and begin commercializing these crops until Russia implements a mechanism for approval of GE crops for cultivation.
At the end of June 2013, the Russian Government announced the merger of three Russian Science Academies (Russian Academy of Sciences, Russian Academy of Agricultural Science and Russian Academy of Medical Science) and the corresponding draft federal law has passed the first two hearings in Duma (Russian main legislative body) in the beginning of July, 2013. The major Russian science institute, which conducts research on GE crops, is the Russian Institute of Agricultural Biotechnology in the Russian Academy of Agricultural Science. It is not clear yet what impact this reorganization will have on this institute’s functioning, but it is unlikely that during the transitional period the scientists in this institute will expand their research work or will lobby in favor of registration of GE crops for cultivation.
b) COMMERCIAL PRODUCTION:
Russia does not cultivate any GE crops, including GE seed production.
Russia imports GE crops, and processed products containing GE ingredients. Imports of GE planting seeds are not allowed since Russia does allow cultivation of GE crops. Imports of GE processed products is allowed if these crops/products have been tested and registered in Russia for food and/or feed use (See paragraph APPROVALS in PART B of the report).
Russian Customs data does not separate GE products from the non-GE products. However, most corn and soybeans imported into Russia, as well as products produced from corn and soybeans, may contain genetically modified organisms. In accordance with Russian and the CU legislation, imported food products are considered non-GMO if the presence of GMOs does not exceed levels determined by Russian and the CU legislation: not more than 0.9 percent of registered or non-registered GMO lines in food products or ingredients, and not more than 0.9 percent of registered GMO lines in feed ingredients. These levels have been fixed under the CU Technical Regulations on safety of food products and, oils and fats, grains, oilseeds, and some other technical regulations. The CU Technical Regulation on Feeds has not been adopted so far, and the Russian requirement for feeds is still in force: for feeds that are declared as non-GMO the presence of registered GMO lines shall not exceed 0.9 percent, and the presence of non-registered GMO lines shall not exceed 0.5 percent. In feeds that are declared as GM, the presence of non-registered GMO lines also shall not exceed 0.5 percent (for more information see section Plant Biotechnology Policy).
Russia is increasing its poultry and swine production at large, integrated poultry and swine farms that use compound feeds in the feeding rations. The demand for protein and energy ingredients, such as corn and soybeans/soybean meal is increasing. Russian is trying to increase domestic production of these crops, and in 2012 Russia’s corn and soybean crops reached record levels: 8.2 million metric tons (MMT) of corn and 1.9 MMT of soybeans. Despite increased domestic production of protein and high energy feeds such as soybeans and corn, Russia continues to import soybeans, corn, and products processed from these crops, although the volumes of these imports have decreased.
Corn imports increased from 44,261 metric tons (MT) to 58,139 MT due to increased imports of corn planting seeds from 27,249 MT to 30,378 MT. All imported planting seeds are required to be non-GMO. Imports of corn other than planting seeds corn increased from 17,011 MT in 2011/12 to 27,761 MT in 2012/13, and imports from the United States were second in volume after Ukraine.
Due to increased domestic production of soybeans, Russia’s imports of soybeans have decreased in the last 3 years and were 620,143 MT in 2012/13. Meanwhile, imports of soybeans from the United States were increasing and reached 55,964 MT in June-May 2012/13, although still far behind imports from Paraguay and Brazil.
The anti-GMO preference of Russian consumers can still influence imports of corn and soybean and their products, especially soybeans and soybean products. In general, the feed trade does not reflect any strong pro- or anti-biotech bias. However, some regions in the south of European Russia, including Belgorod oblast (Russia’s major meat producer), have declared themselves GMO-free-zones and buy only non-GMO feeds, which are more and more difficult to find in the market. The anti-GMO campaign in 2008-2011 affected food processors’ decisions. Importers of these commodities still prefer certified non-GE products in order to meet consumers’ preferences. Russia’s soybean crop is focused in the Far East, and European Russia (in the West) relies largely on imports to meet demand. Sodruzhestvo, Russia’s major soybean crushing company, maintains separate facilities for GE and non-GE soybeans in Kaliningrad.
e) FOOD AID RECIPIENT COUNTRIES:
Russia is not a recipient of food aid.
PART B: POLICY
a) REGULATORY FRAMEWORK:
i. RESPONSIBLE GOVERNMENT MINISTRIES
The following Russian ministries, agencies and services are responsible for development of Russian biotechnology policy, including agricultural biotechnology, and for control and surveillance over use of GE crops and products that are approved for food and/or feed use.
Federal Service for Surveillance in the Sphere of Human Rights Protection and Human Well-Being (Rospotrebnadzor) headed by the Chief Sanitary Doctor of the Russian Federation. Rospotrebnadzor retains all its functions, such as: - conducts 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 accordance with Russian legislation; - conducts state registration of new food products containing GMOs, including those that are imported into Russian for the first time; - keeps the state register of GM food products allowed for sale, production and imports on the territory of the Russian Federation; Since the unified economic space within the Customs Union started on January 1, 2012, 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. Since 2011, Rospotrebnadzor has been issuing new certificates for the whole Customs Union. In addition to these functions, Rospotrebnadzor is now responsible for development of legislation on GE food products, which was the function of the Ministry of Health and Human Well-being before.
The Ministry of Agriculture of the Russian Federation participates in the development of agricultural biotechnology policy together with Ministry of Economic Development and Ministry of Science and Education of the Russian Federation. Its functions are the following: - overall legal regulation in the sphere of veterinary and phytosanitary well-being of Russia aimed at mitigation of any negative effects of GMOs on agricultural animals, plants, the environment, agricultural raw products, processed food products; - overall policy development for the use of GMO in agriculture;
Federal Service for Veterinary and Phytosanitary Surveillance (VPSS) is subordinated to the Ministry of Agriculture of the Russian Federation. With regard to GE approvals, it: - surveys the safety of feeds and feed additives derived from GMO at all stages of production and turnover; - keeps the state registration of feeds derived from GMO; - issues certificates of registration for GM feeds;
The Ministry of Industry and Trade of the Russian Federation 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;
Ministry of Economic Development of the Russian Federation since 2012 monitors the implementation of the Comprehensive Program on Development of Biotechnology in the Russian Federation through 2020;
The Customs Union of Kazakhstan, Russia and Belarus (CU) develops and adopts the common customs and technical regulations for all countries-members of the Customs Union.
ii. LEGISLATION AND REGULATIONS
As of July 2013, 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 (the Head of the Federal Service for Surveillance in the Sphere of Human Rights Protection and Human Well-Being - Rospotrebnadzor) listed below regulate Russian agricultural biotech policy at present. These include laws on product registration and consumer information about GE ingredients in food products. Since Russia became a member of the Customs Union (now Euro-Asian Economic Commission – EEC) its trade legislation is subordinated to the legislation of the Customs Union. As of July 2012, the Customs Union adopted several technical regulations that concern agricultural biotechnology and consumer labeling, and on July 1, 2013, these technical regulations came to force. These are the following Technical Regulations of the Customs Union: Technical Regulation on Food Safety, Technical Regulation on Food Labeling, and Technical Regulation on the Safety of Grain. Another Custom Union Technical Regulation that will be important from the point of view of imports and turnover of GE feeds is the Technical Regulation on Feeds. However, this CU Technical Regulation is still under discussion.
Summary of current Russian laws and regulations that influence agricultural biotechnology:
- 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, an amendment authorized the Government to develop and adopt procedures for the release of the genetically modified organisms into the 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, as of mid-July 2013 the government has not issued any regulatory document concerning the release of GE crops into 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 at 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 states: “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.”
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 foods;
- 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 which 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) at the Ministry of Agriculture of the Russian Fderation.
In accordance with the Federal Program BIO 2020 and the Federal Law No 262-FZ of October 4, 2010 the Russian Ministry of Economic Development and the Russian Ministry of Science and Education prepared and discussed the draft government resolution “On the State Registration of Genetically Modified Organisms for Release into the Environment”, but the draft has not been adopted yet. As of today the draft is still in administrative channels.
Normative acts of government bodies
- Resolution of the Chief Sanitary Doctor of the Russian Federation (No 14 of November 8, 2011), On the Procedures 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 are 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
Since July 2010 the Customs Union adopted several technical regulations that will influence agricultural and food biotechnology. These technical regulations came to force on July 1, 2013, and all regulations require marking the presence of GMOs on labels, and informing consumers in cases when food products are processed from or with the use of GMO even if there is no DNA’s or proteins of GMO components in the marketed food products.
CU Technical Regulation No 021/2011 on Safety of Food Products (adopted in December 2011, came to force on July 1, 2013). The definition of GMO in this technical regulation is “genetically modified (genetically engineered, transgenic) organisms is “an organism or several organisms, any noncellular, unicellular or multicellular formations able for reproduction or transfer of genetic material differing from natural organisms obtained with the use of genetic engineering methods and (or) containing genetically engineered material including genes, their fragments or gene combinations.” This Technical Regulation states the following:
- Food products can be processed only from GMO/GMM registered in the CU (Paragraph 9 of Chapter 2);
- If the producer did not use GMOs at processing of food products, the presence of 0.9 percent and less of GMOs is considered an adventitious, unavoidable presence, and products is not GM (Paragraph 9, Chapter 2);
- The use of GMO in baby food and in food for pregnant and nursing women is not allowed (Paragraph 1 of Article 8).
The testing and examination of presence of GMO in food products is based on the following state standards (GOSTs) and guidelines: GOST R 52173-2003 “Food Raw Material and Food Products.
Methods for detection of genetically modified organisms (GMO) of plant origin”, GOST R 52174-2003 “Biological Safety. Raw materials and food products. Methods for detection of genetically modified organisms (GMO) of plant origin by using biological microchips” and MUK (methodological guidelines) 4.2.2304-007 “On surveillance over circulation of food containing GMO.”
CU Technical Regulation No 022/2011 on Food Labeling (adopted in December 2011 and came to force on July 1, 2013). This technical regulation requires that food products with GMO shall be labeled, and determines the format of this labeling. The presence of 0.9 percent and less of GMO shall not be labeled, and the product is not considered as a GM products. Labeling of food products as non-GMO is voluntary and the absence of GMO shall be proved and documented. For packaged food products requirements the labels shall contain information on the presence of food product ingredients obtained with the use of genetically modified organisms. The GMO ingredient is not excused from being listed in the compound ingredients of food products in cases when the mass of the compound ingredient is not more than 2 percent of the mass of the product (Paragraph 4.10). The information about the specific characteristics of food products, including absence of components obtained from GMO (or) with the use of GMO, shall be confirmed by proofs. Organizations or individual entrepreneurs releasing such food products for circulation in the unified customs area of the CU shall keep the documents with proofs of presence of specific characteristics of food products. The Technical Regulation on Food Labeling also has a special paragraph (4.11.) “Requirements for Specification of Information on Presence of Ingredients Obtained with the Use of Genetically Modified Organisms in Food Products in Food Products Labeling.” The paragraph reads as following:
1. For food products obtained with the use of GMO, including those not containing deoxyribonucleic acid (DNA) and proteins, the following information shall be specified: "Genetically modified products" or "Products obtained from genetically modified organisms", or "The product contains components of genetically modified organisms". If the manufacturer did not use genetically modified organisms in the process of manufacturing food products, the content of GMOs of 0.9 percent or less is an accidental or technically irremovable impurity, and such food products shall not be referred to as food products containing GMOs. When labeling such food products, GMO presence shall not be stated;
2. The indication of the following information is obligatory for food products obtained from genetically modified microorganisms or with the use thereof (bacteria, yeast and filamentous fungi, the genetic material of which was modified with the help of genetic engineering methods) (hereinafter referred to as the GMM): a) For products containing living GMM - "The product contains living genetically modified microorganisms"; b) For products containing unviable GMM - "The product was obtained with the help of genetically modified microorganisms"; c) For products freed from engineered GMM or for products produced with the help of components freed from engineered GMM - "The product contains components obtained with the help of genetically modified microorganisms”;
3. Labeling of food products shall not contain information on GMO presence with respect to the used processing aids, produced from or with the help of genetically modified organisms.
CU Technical Regulation No 015/2001 on the Safety of Grain (adopted in December 2011, came to force on July 1, 2013). The Technical Regulation determines requirements for information on grain/oilseeds during transportation either in bulk of in consumer packs (for feed purposes). Article 4 (Safety Requirements, paragraph 16) stipulates that grain transported unpackeged should be accompanied by shipping documents that ensure its traceability and provide information on GMOs if presence of GMOs is higher than 0.9 percent. …For the grain obtained with the use of GMOs the information should be given: "Genetically modified grain" or "grain obtained from the use of genetically modified organisms" or "grain contains components of genetically modified organisms", indicating the unique identifier of the transformation event. In addition, in the sanitary requirements for grain/oilseeds (MRLs of toxic elements, micotoxins, pesticides, radionuclide and pests) the technical regulation 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 “Grain may contain only those GMO lines that are registered in accordance with the legislation of member states of the Customs Union. In grain that contains a GMO presence of not more than 0.9 percent of non-registered GMO lines is allowed.” The same state standards (GOSTs) as in Technical Regulation 021/2011 shall be applied (GOST R 52173-2003 and GOST R 52174-2003).
CU Technical Regulation No. 024/2011 on Fat and Oil Products (adopted December 2011, which came to force on July 1. 2013) replaced Russian Federal Law “Technical Regulation on Oil and Fat Products” (FL #90 of June 24, 2008). This technical regulation requires labeling of oil and fat products released into circulation for human consumption, and labels shall include information on the presence of GMOs;
CU Technical Regulation No 023/2011 “On Fruit and Vegetable Juices and Their Products” came to force on July 1, 2013. It replaced the Russian Federal Law “Technical Regulation on Fruit and Vegetable Juices and Their Products” FL #178 of October 27, 2009. The CU Technical Regulation on Juices and their products bans the use of GMOs in baby food (fruit and vegetable juice products for babies) and requires state registration of any product that was processed using methods of genetic modification.
iii. GE CROPS/LINES REGISTRATION FOR FOOD AND FEED USE
Registration for Food Use (procedure)
Rospotrebnadzor registers biotech crops and ingredients for food use for Russia and for the Customs Union. The registration process remains the same as was stated in the Annual Biotechnology GAIN reports 2011 and 2012:
• The applicant submits an application and dossier to Rospotrebnadzor;
• Rospotrebnadzor assigns a safety assessment studies 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 GE 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 for food-use in Russia can provide a copy of the crop registration certificate.
Since 2006, Rospotrebnadzor has registered food-use crops for an unlimited time period. Information on GE 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 – Center of Bioengineering of (genetic studies);
- The Moscow State University of Applied Biotechnology (technological assessment).
Registration for Feed Use
Plant-origin feed imports no longer require a veterinary certificate but still require 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 feed 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 VPSS regardless examines the products for the presence of GE components.
If the feed contains GE 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 this requirement is unrelated to biotechnology. Any biotech components in feed must be appropriately registered. Presence of each non-registered biotech line shall not exceed 0.5 percent. The Custom Union’s Technical Regulation on Feeds has not been adopted yet, but the draft has the same 0.5 percent norm of non-registered biotech lines as in the current regulations. However, the adopted Technical Regulation on Safety of Grain stipulates that feed grain/oilseeds is considered non-GMO if the presence of each non-registered biotech lines does not exceed 0.9 percent. The Technical Regulation on Safety of Grain came into to force on July 1, 2013. 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 regulations for registration. 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 a 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.
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 GE 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 is not available to the public.
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 complex. 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 to the company that imports this feed and VPSS requires that each feed that contains a registered GM event also be registered.
iv. RECENT ACTIVITIES OF RUSSIAN AUTHORITIES IN REGARDS TO GE CROPS
Unlike last year, the period from July 2012 through July 2013 has demonstrated that the Russian Government seems to have backed away from greater acceptance and use of GE crops. For instance - In September 2012, Russia became the only country to issue a temporary ban on imports of all products that contain Monsanto’s genetically engineered corn NK603. The ban was based on an article in the EU scientific journal “Food and Chemical Toxicology” which claimed adverse health effects of genetically engineered corn NK603. The ban was introduced by Rospotrebnadzor, reported officially and also widely reported in the mass media. The lifting of the ban several months later was not reported to the public; - The adoption of the Government Resolution on the release of GMO crops into the environment continues to have very little momentum; - The Minister of Agriculture Nikolay Fedorov, confirmed that the Ministry’s position is very “conservative” about the genetically modified organisms1. Since VPSS is subordinated to the Ministry of Agriculture, this “conservative” approach will influence its attitude to GE crops as well. Dr. Nikolay Vlasov, Deputy Head of VPSS, commented on on the issue of biotechnology (GMO) in general, and clarified the VPSS’ position on the web-site of Rosselkhoznadzor (VPSS). He stated that VPSS recognizes the merits of biotechnology and believes that if controlled properly, than GE plants do not bring immediate risks to people. However, there are potential risks, including the “psychological” danger of use of GMOs, and labeling of GMOs in plant products and in some products of animal origin, including bee products and dairy products, shall be mandatory. Despite the temporary ban on imports of NK603, in general, Rospotrebnadzor and Dr. Gennadiy Onishchenko, the Head of Rospotrebnadzor, have expressed positive views of GE crops. For example, Dr. Onishchenko stated at the environmental forum in St. Petersburg on May 24th, 2013 that the global population cannot be adequately fed unless genetically modified products are widely introduced into the food supply: “Without using GMOs [genetically modified organisms] the world can’t be provided with [enough] food.” Onishchenko added that “organic produce” does not exist because modern agricultural practices have made a return to original farming methods impossible. “It’s impossible to live in primitive nature[al conditions], according to patriarchic farming methods.” he said.
In the12 month period from July 2012-June 2013, Russia has registered and re-registered more crops/lines than in the same period the previous year. Since July 2012, Russia registered three new GE crops/lines for feed use (Corn Mon 89034, Corn MIR162, and Soybeans BPS-CV-127-9), and two new crops/lines for food use (Bt soybeans MON 89034 and Soybeans BPS-CV-127-9). In addition, Russia re-registered five crops/lines for feed use (RR soybeans 40-3-2, LL Soybeans A2704-12, LL Soybeans A5547-127, RR corn GA 21, and Corn MIR 604). Moreover, applicants are awaiting re-registration for feed use in August and September/October 2013 of another four crops/lines (Corn Mon 810, Corn NK 603, Corn Mon 88017 (CCR) and Bt soybeans MON 87701).
Since the beginning of registrations of biotech lines for food use in 1999, Russia has approved and registered 23 lines of genetically engineered crops. However, 3 lines such as 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, 2013, Russia has 20 lines of biotech crops that can be legally imported to Russia for food use. These are ten lines of corn, six soybean lines, one sugar beet line, one rice line, and two lines of potato. Of these 20 crops, 17 are also registered for feed use (or awaiting re-registration in August-September 2013), including 11 lines of corn and 6 lines of soybeans. One line of corn (Bt corn MON 863 - registration expires in August 2013), has not been submitted for re-registration because this line is not produced any more. Monsanto, Bayer, Syngenta and BASF were the only four companies to have their biotech crops registered in Russia, and BASF started registering its crops only in 2012/13. 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.
Two crops are waiting approval, including a variety of Monsanto corn for food and for feed use, and Bayer/Syngenta soybeans (stacked products) for food and feed use. It is expected that one new corn line and two soybean lines will be submitted for approval in the end of 2013 – in 2014.
In accordance with the CU Agreement on sanitary measures, since July 1, 2010, Rospotrebnadzor is registering food products for the whole Customs Union 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.)
For feeds VPSS registers feeds and additives only for 5 years. VPSS continues 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. The CU Technical Regulation on Feeds is still under discussion, and has not been adopted.
c) FIELD TESTING
Not applicable. Since there are no legislation and mechanisms for release of GE crops into the environment, Russian researchers do not conduct wide scale field tests of GE crops.
d) STACKED EVENT APPROVALS
Russia approved stacked events for food and for feed use, but required registration of every trait separately. Thus, if the stacked event has three traits, the applicant shall submit documents for every trait, and shall register each trait and then the stacked event. So far Russia issued approvals for three stacked events: Corn Mon 88017 (CCR) approved for food use and expected approval for feed use in August 2013, RR soybeans Mon 89788 (RRS2Y) approved for food and feed use, and Corn BT 11, approved for food and feed use. One stacked event, Soybean HPPD is awaiting approval both for food and feed use.
e) ADDITIONAL REQUIREMENTS:
Not applicable since there is no mechanism and legislation for cultivation of GE crops.
Food labeling: In accordance with the Technical Regulations of the Customs Union that came to force on July 1, 2013, all organizations that import, produce, or trade food products to/in the country-members of the Customs Union (at present Kazakhstan, Russia and Belarus) must inform consumers about the presence of biotech components in food products if each individual biotech event does not exceed 0.9 percent. The methods that should be used to test for biotech presence in food are also specified in the Attachments to the CU Technical Regulations on Food Safety and Food Labeling, and are the same that were used in Russia by Rospotrebnadzor before the CU Technical Regulations on Food labeling and Food Safety came into force. For food products imported to Russia, 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 or 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 lodged on that company. Usually Rospotrebnadzor pays special attention to products containing soybean or corn ingredients. For more information on the CU’s food labeling requirements please see section Decisions of the Customs Union above.
Feed labeling: 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 GMOs in feeds on consumer packs of feeds. The CU Technical Regulation on Feeds is still under discussion, and has not been adopted. The requirements for information on GMO in shipping documents for grain and oilseeds and their products are in the CU’s Technical Regulation on Safety of Grain. For more information please see section Decisions of the Customs Union above.
h) TRADE BARRIERS
Russia has a de-facto ban on cultivation of GE crops, and this impedes the U.S. exports of planting seeds of crops, such as soybeans, rapeseed, sugar beets and corn. Russia’s demand for efficient, drought-resistant varieties and hybrids of planting seeds of these crops is very high, but there is no open market for these seeds.
In September 2012 Russia temporary banned imports of all products that contain Monsanto’s genetically engineered corn NK603. The lifting of the ban several months later was not publically reported;
i) INTELLECTUAL PROPERTY RIGHTS (IPR):
Not applicable so far since there is no official information on the presence of GE crops in the fields of Russian farmers. However, this may become a serious issue if the illegal presence of GE crops is detected in Russian fields.
j) CARTAGENA PROTOCOL RATIFICATION:
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 which 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 acknowledged mechanism to defend its own national policy in the field of biotechnology after WTO accession.
k) INTERNATIONAL TREATIES/FORA:
Russian participates in the APEC High Level Policy Dialogue on Agricultural biotechnology, in the meetings of the CODEX Alimentarius (Codex), and in the meetings of the International Plant Protection Convention (IPPC). However, except for the APEC Dialogue, Russia’s participation in other meetings usually does not cover issues of GE crops/products.
l) RELATED ISSUES:
m) MONITORING AND TESTING
In Russia, Rospotrebnadzor monitors/tests GE food products and VPSS monitors/test grains, oilseeds for animal consumption and feeds and feed additives and ingredients (for more information see paragraph above on the role of different ministries and agencies).
n) LOW LEVEL PRESENCE POLICY
According to the CU Technical Regulations on safety of food products, grains and oilseeds, and on labeling requirements for food products, the present of GE lines, components in food and feeds shall be labeled or reported in accompanying shipping documents only if it exceeds 0.9 percent (for more information see section of this report on CU Technical Regulations.)
PART C: MARKETING
a) MARKET ACCEPTANCE:
Labeling requirements increase the price of food containing GE 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 in Russia, though non-GMO labels can be seen on dairy, eggs and poultry products. Since the Moscow city government stopped requiring non-GMO labeling in 2012, many food processors in Moscow have discontinued these special tests on absence of GMOs, and fewer products are sold with the special “Does not contain GMO” label. However, food processors still prefer purchasing non-GE products, especially soybeans and soybean products.
b) PUBLIC/PRIVATE OPINIONS:
There are no active pro-GE organizations, with the exception of a few select farmers organizations and unions that are interested in increasing Russia’s grain and oilseeds production. On the other hand, Russian Greenpeace and the the Alliance of the CIS Countries “For Biosafety” are very active in the anti-GMO campaigns. Public opinion in general reflects a negative attitude to GMOs. However, this negative opinion is seldom reflected in purchasing priorities of the Russian population, which are based on the price of products. Meanwhile, the circulation of the rumors about the possible adoption of the draft government resolution on the state registration of genetically modified organisms for release into environment seemed to stimulate anti-GMO campaigners. One campaigner, who also did not see the final text of the draft, sent a petition to President Putin (with over 20,000 signatures) that this resolution may harm Russia’s security.
c) MARKETING STUDIES:
PART D: CAPACITY BUILDING AND OUTREACH:
By the spring of 2013, following the publication and the open public discussion of the draft Government Resolution on registration of GE crops for release into environment the activities of anti-biotech groups increased and the anti-biotech campaign intensified. It was also connected with Russia’s WTO accession. The penetration of agricultural biotechnology to Russia is presented asnot only as a threat for public health, but as a threat to Russia’s domestic agricultural production. 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.
CHAPTER 2: ANIMAL BIOTECHNOLOGY:
PART E: PRODUCTION AND TRADE
a. BIOTECHNOLOGY PRODUCT DEVELOPMENT: Research on GE animals was conducted in Russia under the guidance of Professor Lev Ernst, Academician of the Russian Academy of Sciences and the Russian Academy of Agricultural Sciences (died in April 2012) in the cloning and genetic modification of animals immune to infection diseases. However, during the last two years there has been no information on the continuation of this research.
b. COMMERCIAL PRODUCTION: Increased cattle production is one of the priorities of the Russian Government and it supports low interest rates on loans to livestock producers, including loans for importing pedigree breeding animals, semen and embryos. This support does not include any research on GE animals or clones.
c. BIOTECHNOLOGY EXPORTS: Russia does not export any GE animals or livestock clones.
d. BIOTECHNOLOGY IMPORTS: Russia does not import any GE animals or livestock clones.
PART F: POLICY
a. REGULATION: Russia’s Program BIO 2020 states that Agricultural biotechnology is a “section of biotechnology dealing with issues of theory, methodology and implementation of its achievements in plant and livestock production.” However, in the recently adopted State Program for Development of Russian agriculture in 2013 the development of biotechnology in animal and feeds production envisages development of bio-additives for improvement of quality of feeds – amino-acids, feed protein, ferments, vitamins probiotics. But it includes no mention on GE animals or cloning.
b. LABELING AND TRACEABILITY: Not applicable.
c. TRADE BARRIERS: None
d. INTELLECTUAL PROPERTY RIGHTS: Not applicable
e. INTERNATIONAL TREATIES/FORA: Not applicable
PART G: MARKETING
a. MARKET ACCEPTANCE: Not applicable
b. PUBLIC/PRIVATE OPINIONS: Not applicable
c. MARKET STUDIES: There are no known market studies on the marketing of animal biotechnology products in Russia.
PART H: CAPACITY BUILDING AND OUTREACH
a. ACTIVITIES: None of the biotechnology-related capacity building activities with Russia had any component on animal biotechnology.
b. STRATEGIES AND NEEDS: Currently none