УДК 504.06: 575.856(476)(047.31)
A.V. Kilchevsky, S.E. Dromashko
NATIONAL BIOSAFETY SYSTEM OF THE REPUBLIC OF BELARUS
Institute of Genetics and Cytology, National Academy of Sciences of Belarus, Minsk, Belarus
Система биобезопасности Республики Беларусь разработана с учетом особенностей ее национального законодательства и государственного управления для того, чтобы: 1) защитить человека и природу при осуществлении ГИД и использовании ее результатов; 2) максимально способствовать использованию современных биотехнологий для укрепления экономического положения РБ; 3) воспрепятствовать росту финансовых затрат республиканского бюджета; 4) обеспечить максимальную свободу доступа общественности к информации по биобезопасности. Она полностью отвечает требованиям Картахенского протокола по биобезопасности к Конвенции о биологическом разнообразии.
Introduction. The governments of the many countries of the world support the development of modern biotechnologies as an important factor of the economy growth, increase of well-being of the population and rise of national production competitiveness. The number of biotechnological enterprises in countries of the European Union (EU) approaches to 2000, and their profits come to tens of billions of euro. Agricultural business also develops rapidly, using practical achievements of genetic engineering – genetically modified organisms (GMO). In accordance with predictions of the researchers, arable land in the world will decrease from ½ to ¼ hectare per person to 2025, since the human population on our planet today amounts to 6.6 billions of persons, and, with increase per annum approximately by 80 millions it will reach 9 billions of persons by 2050. That is why even industrially developed countries can face the problem of lacking food products per capita.
Hundreds examples are evidence of successful creation of GM-plants and their enormous practical value so it is expected that about 80 % of 29 main agricultural crops will be sown with GM-seeds in the nearest 10–20 years, since their cultivation brings an essential economic profit.
In Belarus, scientific studies, having for the ultimate objective transgenic plants development, were started by the initiative of academician N. A. Kartel in 2002 within the framework of the State Program «Genetic Engineering». In particular, tobacco model plants resistant to high doses of heavy metals and oil products were developed in the laboratory directed by him, at the Institute of Genetics and Cytology of the National Academy of Sciences of Belarus (NASB) by 2006. Nowadays works on DNA-technology use for agriculture and public health are continued in a number of the institutes of the National Academy of Sciences of Belarus and the Ministry of Public Health within the framework of the State Program «Innovation Biotechnologies». Transgenic pants of potato with a chitinase gene from bacterium Serratia plymuthica, those of tobacco with a gene cytochrome P450scc gene, flax, oil-bearing rape, American blueberry and others will be developed as a result of this program realization.
Main Part. If economic profit from GMO use is obvious on the whole, their safety, as before, causes the hot discussion, long ago having fallen outside the scope of laboratories and forums. This concerns, particularly genetically modified plants, large-scale use of which must be under strict control in order to avoid increase of possible risks.
The governmental commissions and non-governmental organizations like «Greenpeace» debate on safety use of the transgenic plants and animals in agriculture. That is why study of GMO safety is an important part of the program on scientific and technological developments in applied molecular biology. They fall far off outside the scope of science at the level of the paramount tasks of states and international organizations, whose duties are to ensure favorable conditions for life on the planet Earth.
One of the important documents, specifying genetic-engineering activity (GEA) and simultaneously adjusting interstate relations, is the Convention on Biological Diversity (CBD, Rio de Janeiro, June 1992). It proclaims responsibility of mankind for conservation, stable use and long-term development of the biological diversity. The Convention also includes problems of the natural areas conservation, rational use of biological resources, reconstruction of degraded ecosystems, and threatened species, strict control over modern biotechnologies, elaborations of the national ecological networks and legislative basis. In accordance with the principle of taking safety measures (the precautionary approach contained in Principle 15 of the Rio Declaration on Environment and Development, i.e. CBD), Cartagena Protocol on Biosafety (CPB) to the CBD was worked out in 2000, came into force on September 11, 2003, and, as of August 2010, was ratified by the majority of the CBD-parties (160 from 192 UN-states-members). The purpose of the CPB is the assistance to national governments in ensuring an adequate level of protection in the field of safe transfer, handling, processing and use living genetically modified organism (LMO/GMO) resulting from modern biotechnology (including genetic modification, GM) and capable to render adverse effects on the conservation and sustainable use of biological diversity, taking into account risks for human health, and specifically focusing on transboundary movements.
The Resolution of the Council of Ministers of the Republic of Belarus «On creation of the National Co-ordination Biosafety Centre» of June 19, 1998 No 963 was the first step in solving these problems in our country. According to this Resolution the corresponding functions were entrusted to the Institute of Genetics and Cytology of NASB, where the special structure subdivision – the National Co-ordination Biosafety Centre (NCBC) was set up.
The main aim of NCBC is regulating and co-ordination of the work in the field of realization of the strategies and national plan of actions on conservation and sustainable use of biodiversity within the CBD framework. The tasks of NCBC are as follows:
1) collection, analysis and systematization of information on legislation and scientific study on the biosafety questions, field trials of gene engineering objects, import (export), commercial use of GMOs and products on their basis in Belarus, as well as specified information on biosafety from databases of the international information networks, development of a national database on biosafety and GMOs;
2) granting of this information to all interested ministries and other organs of state management, mass media, people and public associations;
3) exchange of information with co-ordination centres of other countries and international organizations;
4) conduct of the state register of experts on biosafety in the field of GEA (in common with the Ministry of Natural Resources and Environment Protection);
5) ensuring the scientific expertise in the field of GMO safety (in common with experts of the state register);
6) rendering the consulting services to ministries and other republican organs of state management in development of legislation act projects, concerning import (export) and safe use of GMOs and products on their basis, manuals of estimation and prevention of risks for environment and human health, instructions on safety measures for laboratories of genetic engineering;
7) rendering the consulting services to ministries and other republican organs of state management in preparing the proposals on conclusion of bilateral and regional agreements, in development of the international agreements on biosafety problems, and realization of functions corresponding to legislation.
Having joined to Cartagena Protocol on 6 May 2002, the Republic of Belarus developed the national system of biosafety in the genetic engineering activity (GEA-safety).
The Resolution of the Council of Ministers of the Republic of Belarus «On measures for realization of the clauses of Cartagena Protocol on Biosafety to the Convention on Biological Diversity» of June 5, 2002 No 734 was a basis for creation of a number of competent national organs. They are the Ministry of Natural Resources and Environment Protection (hereinafter – Ministry of Nature) in a part of functions concerned with GMO release into environment, the Ministry of Health and the Ministry of Agriculture and Food – for problems of the GMO use in economic activity. According to this resolution the function of relation with CPB secretariat is entrusted to NCBC.
The basis of the concept of the government regulation of GEA safety in Belarus includes the total world experience, Belarusian legislation and state management system established in the country, its international agreements obligations. The most important statements of the concepts were represented in the Law of the Republic of Belarus «On the Safety in Gene-engineering Activity» (hereinafter – the Law), passed in January 9, 2006. This Law together with documents of current legislation and other legal documents, worked out for its development, is the main resources of the normative legal basis of the developing national biosafety system. This system provides realization of the Belarus people rights of life, health protection, information, and of prevention of these rights breach.
The Law establishes legal and organizing bases of the GEA safety protection. Its clauses do not apply to relations, associated with using genetic engineering to human, his organs and tissues, handling of pharmaceuticals, food raw materials and food-stuffs, feed for animals, obtained from GMO or their component (clause 2), since they are controlled by special legislation about public health. The following measures are determined in clause 5 of the Law on protection of GEA safety: acceptance of the normative legal documents; approval and implementation of the technical normative legal documents in the field of GEA safety and their realization; undertaking the state expertise in GMO safety; realization of control in the field of GEA safety, and a number of other measures of the biosafety protection.
The Resolution of the Council of Ministers of 4 May 2010 No 677 (approved by the decree of the President of the Republic of Belarus No 5/31786, signed on 07.05.2010) «On Approving the Regulation on Order of the Undertaking Risk Assessment of Possible Deleterious Effects of Gene-engineering Organisms on Human Health». The Resolution specifies estimation of GMO use risk in Belarus. An order and common requirements were determined for risk assessment of possible harmful GMO influence on human health. The Resolution uses following main terms: risk assessment – a determination of probability of the bad GMO influence on human health; factors of the risk – GMO features, associated with genetic modification, which can expert a deleterious effect on human health. The risk assessment is curried out for determination of possible deleterious GMO effects influence on human health, estimation of probability and degree of such effect danger, as well as ways of their prevention and control (management).
The risk assessment is carried out by experts realizing GEA, juridical persons and individual businessmen. In accordance with legislation order, the information obtained is included in materials, which juridical persons and the individual businessmen submit to the Ministry of Nature for undertaking the state expertise of GEA safety. If new information on GMOs and their influence on human health is obtained, the results of risk assessment can be revised. Determination of responsibility for breach of the legislation requirements (clause 5 of the Law «On Safety of Gene-engineering Activity») is one of the most important measures for GEA protection. The Law «On Contributing the Additions in Some Codes of the Republic of Belarus on Questions of Determination of Responsibility for Breach of Legislation about Safety of Gene-engineering Activity» was adopted on 18 May 2007 with the purpose of realization of the specified prescription. It contributes a number of the additions to administrative and criminal legislation of the country. The Part 1 of the Article 15.4 of the Code of the Republic of Belarus on Administrative Responsibility (hereinafter – COAR) provides responsibility for breach of the rules of safety production, storage, use, transportation, burning and other manipulations with radioactive, bacteriological, chemical materials or wastes of production and consumption. These COAR regulations were supplemented with the instruction that such a responsibility follows in the case of similar actions with GMOs. The Part 1 of the Article 278 of the Criminal Code also includes additions, similar to measures contributed in the Part 1 of the Article 15.4 of COAR, according to which the responsibility is determined for similar breaches of the safety rules: in the case of administrative prejudice (i.e. when a judicial decision has already came into effect) a fine is imposed in the size from 20 to 1000 datum values (≈ 10 thousand US$); the size of criminal responsibility for similar breaches is up to 7 years of imprisonment.
Legislation of Belarus does not prohibit use and circulation of food raw material and food-stuffs, produced from GMOs, but in accordance with the Laws of the Republic «On Quality and Safety of Food Raw Material and Food-stuffs for Human Life and Health» [National Register of the Legal Documents (NRLD). 2003, No 79, 2/966) and «On Protection of the Rights of the Consumers» (NRLD. 2003, No 8, 2/932) a buyer has a right of getting information on food product, including such data as GMO or their components content in them. The republican system of GMO control organization includes 15 test laboratories, of them 6 – under the auspices of the Ministry of Public Health, 6 – belongs to the State Committee for Standardization, 2 – of the NASB and 1 – of the Ministry of Agriculture and Food.
In accordance with Belarusian legislation, an estimation of transgenic plant biosafety in specially equipped experimental fields (testing area) is an obligatory condition for their use in agricultural practice. Such fields for trials are developed at the Academy of Sciences of Belarus (the Institute of Genetics and Cytology, and the Scientific and Practical Center for Potato, Vegetable and Fruit Growing).
Conclusion. On the whole, it should be noted that in Belarus there are all conditions for successful introduction of transgenic plants, developed by home and foreign scientists: sufficient legislative foundation were laid down, and creation of appropriate infrastructure for fields trials is being completed. Rational introduction of transgenic plants in agrocoenoses will make it possible to raise their productivity, to use more effectively (economically) the remedies of plant protection, to reduce expenditures of labor in growing agricultural crops.
The biosafety system of the Republic of Belarus (BS) is elaborated taking into account properties of national legislation and state management. BS ensure an adequate level of protection for human being and nature in the field of the safe productive use of genetic modified organisms (GMOs). BS completely corresponds to the international Cartagena Protocol on Biosafety to the Convention on Biological Diversity.
