national biosafety framework - unepnational biosafety framework ... bch biosafety clearing house...

KYRGYZ REPUBLIC UNITED NATIONS ENVIRONMENT MINISTRY OF ECOLOGY GLOBAL ENVIRONMENTAL PROGRAMME AND EMERGENCIES FACILITY

NATIONAL BIOSAFETY FRAMEWORK

Produced within the UNEP/GEF Project GF/2716-01-4319 “Development of the National Biosafety Framework in the Kyrgyz Republic”

Bishkek, 2005

CONTENTS List of Abbreviations…………………………………………………………………………… Foreword…………………………………………………………………………………………...6 Introduction………………………………………………………………………………………..9 Chapter 1. National policy and international cooperation in the field of biosafety………….13 Chapter 2. Framework of Cartagena protocol on biosafety in national system of biosafety...20

2.1. Normative base and its conformity to the NBF…………………………………20 2.2. Administrative structure (functions and regulatory regime)………………….23 2.3. Coordination mechanism and its functions……………………………………..27 2.4. Expert structure, its potential and a role in risks assessment………………...29 2.5. Monitoring system and responsibility for infringement of biosafety

regulations……………………………………………………………………….31 2.6. Information System and public participation in decision-making…………….32 2.7. Obligations of the Kyrgyz Republic and formation of the reporting

mechanism……………………………………………………………………….34 Chapter 3. Procedural requirements for regulatory mechanisms in national system on

biosafety……………………………………………………………………………….36 3.1. Procedure of Applications processing ………………………………………….36

а) Application (format and requirements)………………………………………36 b) Confirmation (format, requirements and terms to fulfil the duties)………..38 с) Experts’ risk assessment (procedure of formation of expert groups and risks

assessment, requirements, methods and format for risks assessment and the Report)………………………………………………………………… 38

d) Decision (procedure, requirements and terms of preparation)……………..39 e) Requirements on additional information submission (procedure)………….39 f) Procedure on decision-making…………………………………………………39 g) Change (revision) of decisions (procedure)…………………………………..40 h) Resume with regard to rights and obligations of parties to Cartagena Protocol

on Biosafety on Applications processing in accordance with procedure on prior informed consent ………………………………………… 40

i) Resume on rights and obligations of Parties in accordance with Article 11 of the Cartagena Protocol with regard to procedures on Applications processing on LMO’s, used as food, feed or for processing………………….. 41

3.2. The register admitted for use in the country transgenetic organisms………...41 3.3. Tests ( format, procedures and rules)…………………………………………...42 3.4. Monitoring and the control (procedures and rules)……………………………43 3.5. Export and transit of transgenetic organisms………………………………….44 3.6. Illegal transboundary movement and emergency situation …………………..44 3.7. Confidential information and the order of its protection……………………...44 3.8. Comments gathering and their processing……………………………………..44 3.9. Country reports on obligations and implemented arrangements…………….45

Chapter 4. Needs for capacity building creation for the purposes of Cartagena protocol

implementation …………………………………………………………………….46

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Promotion project and capacity building strengthening necessary for National Biosafety Framework implementation (NBF) and obligations of the Kyrgyz Republic on Cartagena Protocol ……………………………………………………

Chapter 5. Information on the project implementation………………………………………50

Main Phases of the Project:…………………………………………………………. Stage 1. Study of the situation and preparation of the National Survey on Biosafety of

the Kyrgyz Republic…………………………………………. Stage 2. Analysis and consultations…………………………………………………. Stage 3. Preparation of the National Biosafety Framework of the Kyrgyz

Republic……………………………………………………………………... Workshops and working meetings on biosafety…………………………………….. List experts and consultants of the project………………………………………….. List of material published within the framework of the project …………………..

Annex I. The decision of the Government of the Kyrgyz Republic On the draft law of the Kyrgyz

Republic «On accession of the Kyrgyz Republic to Cartagena Protocol on Biosafety of the UN Convention on Biological Diversity»…………………………… 59

Annex II. Draft law of the Kyrgyz Republic «On Biological Safety»………………………….60 Annex III. Intergovernmental Committee on Cartagena Protocol

Recommendation 3/5, the Annex III «the Manual on implementation and introduction of Cartagena Protocol provisions» …………………….……………... 83

Annex IV. The basic requirements on procedure of expert risks assessment According to article 15 of Cartagena Protocol on Biosafety and Article 12 of draft law of the Kyrgyz Republic «On Biological Safety»…………………………. 88

Annex V. Information for the Application, required according to articles 8,10 and 13 of

Cartagena Protocol on Biosafety and Article 9 of the draft law «On biological safety» (for prior informed consent procedure)…………………………………….. 90

Annex VI. Information of the Notice required concerning the use in closed systems and import of

living modified organisms, intended for direct use as the foods, feed or for processing at local enterprises, according to Article 11 Cartagena Protocol and Article 9 of the draft law «On Biological Safety»……………………………… 91

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LIST OF ABBREVATIONS

CEN European Committee on Standardization IMPEL Initiative of the EU control authorities on review of activities in the sphere of

ecological enforcement MAB UNESCO Program “Man&Biosphere” REPIN Network on the realization of programs on environmental regulation of ///////?

СРГ ПДООС UNCED United Nations Conference on Environment and Development, Rio de

Janeiro, 1992 БАA Biologically Active Additions INCSB Information network and consultative service on biosafety BSES Biologically-Social Emergency Situation (an accident) DGP Domestic Growth ProductВнутренний валовый продукт TCPM Temporary Committee on phytosanitary measures under the Convention for

the Protection of New Varieties of Plants (UPOV) WHO World Health Organization WSSD World Summit on Sustainable Development, Johannesburg, 2002 WТО World Trade Organization WТО-CТE WTO Committee on Trade and Environment GATT General Agreement on Tariffs and Trade RGC Russian Genetic Committee GМ-cultures Genetically modified cultures GMO Genetically modified organism GM-crops Genetically modified crops GEF Global Ecological Fund DNA Desoxyribonucleic acid EOPQ European Organization on Plants Quarantine ЕU European Union UNEEC UN European Economical Commission LMO Living modified organism LMO-FFO Living modified organisms aimed at direct utilization as food, feed and

processing PPIC Procedure on Prior Informed Consent ICLWRM International Center on living water resources management IWR Institute of World Resources ИПВО Informative Manual on Release of Organisms ИСТА International Organization on Seeds Testing CBD Convention on Biological Diversity CFD Complex Foundation for Development CPB Cartagena Protocol on Biosafety CP CBD Conference of Parties to the Convention on Biological Diversity CP/PP Conference of Parties, acting as the parties of the Protocol on meetings UPOV International Convention for the Protection of New Varieties of Plants IPCP International Protocol on Cartagena Protocol ICCB Interdepartmental Coordination Council (Commission) on biosafety ICPP International Convention for Plants Protection BCH Biosafety Clearing House MEC Multilateral Environmental Conventions IUCN International Union for the Conservation of Nature МAEP Multilateral Agreement on Environmental Protection

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UNEP-ITGB UNEP International technical guidelines on biosafety in the field of biotechnology

IME International Management on Epizootic ICGEB International center on genetic engineering and biotechnology NGO’s Non-governmental organizations NSPA National Strategy on Poverty Alleviation UN United Nations CCTEEC Common Custom Tariff of the Eurasian Economical Community ОЭСР Organization on Economical Cooperation and Development IPR’s Intellectual prorterty rights BCH Biosafety Clearing House Mechanism – established in accordance with

Article 18(3) of the Convention on Biological Convention RNA Ribonudeic acid СBSTCS Complementary body on scientific, technological and consulting services CITES Convention on International Trade of Endangered Species MDN UNEP microbiological data network CIS Community of Independent States SPS Agreement Agreement on sanitary and phytosanitary measures TBT Agreement Agreement on Technical Barriers in Trade SWG PAIP Special Working Group in Plan of Actions Implementation on Environmental

Protection for Central and Eastern Europe SAAB Specially Authorized Administrative Bodies USA United State of America TM Transboundary Movement FAO Food and Agriculture Organization of the United Nations CAI Central Asian Initiative on Sustainable Development / Agenda for 21st

Century ES EECCA Ecological Strategy for Eastern Europe, Caucasus and Central Asia UNEP United Nations Environmental Program UNESCO UN Organization on Education, Science and Culture UNIDO United Nations Industrial Development Organization UNCTD UN Conference on Trade and Development

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THE FOREWORD

In modern conditions for maintenance of a high level of life of the population, political, public and scientific figures direct the efforts to searches of new methods of reception of food stuffs, the goods and services. We are witnesses of fast transition from Mendel classical genetics to introduction of achievements of molecular biology in agriculture, medicine and the industry. Development of new technologies has allowed manipulating with genes. In the developed countries the biotechnological industry is created. Certain large corporations in Europe and the USA direct significant investments on adaptation of new technologies to solve the main problems of agricultural production by creation of highly productive varieties of plants, breeds of animals and their use in wide scales. Intensive works on creation of transgenetic organisms and to their large-scale introduction in an environment are conducted.

For the time being there are 25000 different transgenetic cultures are already passed field tests, and transgenetic plants (corn, soya, cotton) all over the world makes crops about 58 million hectares. In 2000 the market transgenetic varieties has made 3 billion dollars, in 2010 it can make 25 billion dollars.

Developing biotechnology promises to find the ways to solve problems of increase of efficiency of plants, however for certain years the international community is involved in intensive discussions about potential risks and advantages of modern biotechnology. Scientists and different layers of the public have polar opinions concerning large-scale use of genetically modified organisms and their influences on biodiversity and human health.

Threats of transgenetic organisms are connected to their small level of scrutiny, unpredictability of their behavior in an environment and absence of mechanisms of their control. Practically in all countries deliberate release of transgenetic organisms to the environment is regulated by corresponding laws. In the Kyrgyz Republic the problem of state regulation on introduction of transgenetic organisms has already risen. Today we have the information on planting of different cultures in territory of our country, including zones where primogenitors of cultural plants are growing. In conditions of high vulnerability of biodiversity in natural ecosystems, without preliminary research and estimation of risk of potential threats, introduction of such plants to the environment taking into account that they can sibling with wild relatives is inadmissible.

At present time it is not completely indifferent to us, what kind of products are delivered to our country and how we can treat the introduction of an advanced science - modern biotechnology. And we are obliged to provide biosafety of the country. Therefore we should know these problems, train and educate the population and discuss them at all levels.

The effective system of biosafety includes measures of political, legal, scientific, economic, medical, operative, forecast, informative and general educational direction with participation and promotion of efforts of all authorities, business sector, public groups (movements), and also all citizens of the Kyrgyz Republic.

The problem of maintenance of the biosafety, connected with human health care, maintenance of his physical and social activity, touch upon the interests of each citizen and the state. Necessity of revision of the system on biosafety maintenance traditionally treated as struggle against epidemics, is caused by expansion of the range of both internal and external threats raised from known (usual) as well as new sources of biological danger.

In the Agenda for 21 century, accepted in June, 1992 in Rio de Janeiro at Conference of the United Nations on Environment and Development (UNCED, chapter 16), is stated, that advanced achievements of biotechnology are not capable to solve all fundamental problems of the environment and development, but if they are developed and applied in a rational way they are capable to contribute essentially to sustainable development, including public health services, improvement of food security,

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increase of efficiency of processes of industrial processing of raw material and disinfecting of waste products, etc. The Biotechnology opens new opportunities for global partnership.

UN Convention on Biological Diversity, ratified by the Kyrgyz Republic in 1996, calls the Parties to establish and support means of regulation, control or restriction of the risks connected to use and liberation of living modified organisms (LMO’s), created through the application of modern biotechnology which can have the negative ecological consequences, capable to affect preservation and sustainable use of biological diversity, taking into account the risks on human health (Article 8g).

Cartagena Protocol on Biosafety to the UN Convention on Biological Diversity, signed in January, 2000 and entered into force on September, 11, 2003, is the appendix to the Convention on Biological Diversity (Article 19, paragraph 3) regarding acceptance of security measures and regulation of risks related possible impact on biodiversity and human health. The basic purpose of the Protocol is to assist and maintain adequate level of protection in the field of safe processing, transportation, transfer, use and liberation of LMO’s, created through the application of modern biotechnology and capable to make negative impact on preservation and sustainable use of a biological diversity, taking into account risks for human health.

The world community has prepared Cartagena Protocol on Biosafety to the UN Convention on Biological Diversity which is the basic international document that deals with biosafety matters. Each Party joined to the Protocol will enter and realize preventive measures in order to avoid negative impact of transgenetic organisms to the environment and human health. These measures should include risks assessment of transgenetic organisms to the environment and the requirements to inform all stakeholders concerned, as well as information exchange and consultations with consumers of transgenetic organisms. Protocol requires from the parties to establish new or support already existing means for national regulation and management of the risks connected with introduction of transgenetic organisms. The report also provides that the states which have signed it will take all necessary measures to warn or reduce to a minimum the risks from transboundary damage.

Protocol provides for to the Parties significant benefits, providing globally coordinated rules with regard to living modified organisms, which is important, first of all, for the maintenance of transparency in processes of transboundary movements of living modified organisms and application of the procedure on prior informed consent in case of importation. At the same time Protocol establishes institutional mechanism and procedures of risks assessment of living modified organisms movements, and also to encourage the observance of the Protocol’s provisions. The overall goal and final benefit will be to provide higher degree of legal confidence in the field of biosafety regulation. These benefits could be realized only in the event of the Protocol ratification and effective implementation.

More over, in the Protocol determined institutional mechanisms responsible for continuation of the work on development and review of rules on safe transboundary movement, processing and use of living modified organisms. A number of international organizations have proposed assistance in capacity building creation for national systems on biosafety in developing countries that are Party to the Protocol, and also for the expansion of their national opportunities for carrying out risks assessment and regulation connected to biotechnology. Creation of corresponding information systems and development of human resources and the expert potential, having the importance from the point of view of matters related to the biosafety maintenance at national and regional levels.

Being the Party of the present Protocol, the Kyrgyz Republic receives a number of benefits:

1 Opportunity to influence on Protocol’s provisions implementation and its further development through participation in decision-making processes at Conference of the Parties;

2 For the Parties which are developing countries or the countries transition, there are opportunities to receive financial support, rendered by Global Ecological Fund (GEF) (financial mechanism of the Protocol) for capacity building activities, and other purposes aimed at implementation of the Protocol and participation in the processes;

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3 Increase of reliability and realness of national systems on biosafety within the world community;

4 Assistance in the coordination of rules, procedures and other kinds of practices with regard to the management of GMO’s transboundary movement;

5 Demonstration of obligations concerning preservation and sustainable use of biological diversity through the implementation of national measures on biosafety, and etc.

More over, in the Protocol are determined institutional mechanisms on support of national systems on biosafety and continuation of the work on development of legal bases on safe transboundary movement, processing and use of GMO’s, and also mechanisms to receive financial resources to assist in creation of the potential of national systems on biosafety in developing countries parties to the Protocol. Expansion of national opportunities for carrying out assessment and regulation of risks, creation of relevant information systems connected to biotechnology, human resources development and the expert potential that have the importance from the point of view of matters related to the maintenance of biosafety at national and regional levels. One f the requirements of Cartagena Protocol on biosafety is the creation in the country of a regulatory regime with good legislative base, efficient structure with presence of the modern laboratory and highly qualified experts. Thus, biosafety includes very wide aspect of control functions from the customs control and standardization of conformity of the imported goods, phytosanitary, sanitary-and-epidemiologic and sorts’ control up to the technical control of safety of the production, prevention of emergencies, as well as sanitary-and-epidemiologic control of LMO’s/GMO’s turnover and their penetrations to the environment and the control over prevention of possible negative impact on biodiversity of relative species of wild flora due to the sibbing of relative kinds of cultural plants with GM-crops. This danger has special importance, taking into account the fact that Kyrgyzstan is a part of one of the world’s centers of origin for cultural plants. The genofund of wild ancestors of the cultivars, having global value, can undergo to serious risk. Realization of the present project UNEP/GEF in the Kyrgyz Republic and prepared National Biosafety Framework is the basis to solve matters and promote occurrence of the country into the world network on biosafety maintenance.

The Deputy Minister of Ecology and Emergencies of the Kyrgyz Republic Kanat Januzakov, National Coordinator of the UNEP/GEF Project «Development of biosafety framework in the Kyrgyz Republic» Azamat Hudaibergenov

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INTRODUCTION

Revolutionary achievements of physical and chemical biology, genetics and microbiology provided the progress in the biotechnology development which is recently got qualitatively new composition, which is make this sphere practical and attract the flow of considerable investments to this new branch of production. Modern biotechnology oriented on direct construction of genetic systems and therefore, on creation of totally new organisms and biological systems in industrial reactors with output of the ready made product with ordered features. More over, methods of genetic engineering opens the possibilities to create organisms with desirable features or fix hereditary “defects” of plants and animals. Due to this fact modern biotechnology andits perspective direction- genetic engineering make bigger influence on agriculture development, medicine, industry. Efficiency of its application starts to be taken into account in different economical programs and strategies on sustainable development. Use of ideas and methods of biotechnology becoming important in Kyrgyzstan as well, especially for medicinal purposes and for the intensification of agricultural production. Developing technologies of genetic engineering promises to find solutions of matters in the production of pharmaceutical products, biologically active additions, and feed and food products. However, international community in recent years is already involved into long term discussion on potential risks and advantageous of these technologies. Basically, all the warnings are raised by comparatively insufficient experience in application of genetic technologies and by the fact that interaction of transgenetic organisms with places of dwelling has a long term character, and in a long term perspective the results of this interaction remain unpredictable. The danger of transgenetic organisms connected with insufficient studies of long term consequences of their application, and absence of control and monitoring mechanisms. Despite of the fact that transgenetic organisms are the biggest achievement of science, they still could be dangerous as well in hands of incompetent users. All these controversial disagreements created broad political discussions with regard to the scale of genetic engineering achievements application, what kind risks could be emerged and whether are they economically reasonable? In modern society any delay could lead the country to economical disadvantageous, especially in the field of science, scientific and technological progress and implementation of leading technologies that could provide production of more cheaper products. All of that serve as the basis for implementation of regulation methods of both, genetic engineering and control and regulation of application and implementation into practice of achievements of this activity. Create national regulatory mechanisms and define their scale was not an easy task, since the main task was to define sustainable balance between potentially important technological advantageous and adequate guarantees on environmental protection and human health. Recently, international role of rights institute more frequently used as the “guarantee” of the world biosafety, e.g. as the creator of integrated commonality of national mechanisms and requirements that provide for safe creation and transgenetic organisms economical utilization and biotechnology products. The tasks on biosafety provision in the light of expanding geography of transboundary movement of LMO’s/GMO’s could be solved only under coordinative approach of all countries and development of common principles on transgenetic organisms’ turnover regulation, and Cartagena Protocol is the most important legal basis on capacity building creation of the international biosafety system. Kyrgyzstan recognizes the necessity of the national legislation improvement in the field of biosafety and taking into account the necessity of the broad and effective international cooperation in the field of environmental protection, biodiversity preservation and sustainable development on the basis of natural resources management on the entire territory, actively participates in all international initiatives. Kyrgyzstan develops its policy in the field of genetic resources and human health protection and other fields related to security matters in the country on the initial stage of development. I recent years on the basis of international experience certain results have been achieved in national strategies development, programs and plans of action and key principles determined in national norms regulation in the field of natural resources management and environmental protection

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as the basis of economical and socially sustainable development and ecological safety. Ecological safety matters were reflected in the following documents:

- National Plan of Actions on Environmental Protection –NPAEP (1995) - State Plan of Actions on Environmental Hygiene – SPAEH (1999); - State Program “The Earth” till 2005 (1998); - Complex Foundations for Development till 2010-CFD (2001) - National Strategy on Poverty Alleviation on the period 2003-2005 – NSPA (2001) - Strategy on Biodiversity Preservation (2002); - Concept of Transition to Sustainable Development till 2010 –CTSD (2002); - Program of Actions till 2010. “Agenda for 21st Century” (2002); - Concept of the National Policy in the Field of Healthy (Functional) nutrition of the population

(2003); - Concept of Forestry Development (2004).

However, at present time in Kyrgyzstan there is no any normative - legal basis, institutional mechanisms for regulation, control and monitoring of transgenetic organisms use, system on risks assessment and intersectoral partnership and public awareness and participation in decision making. Present NBF is the initial phase for the development of the national system on biosafety. NBF is based on broad technical and legal survey of Kyrgyzstan’s experience on control and environmental safety regulation and human health, norms and natural resources management and biodiversity preservation, as well as on the results of consultations and workshops for decision makers, producers and NGO’s. During its preparation, experiences of many countries on biosafety regulation and the most appropriate to national needs and possibilities, regulation mechanisms were applied as well as administrative systems and principles of intersectoral partnership relations. All of this suppose to promote effective application of legal norms of the national biosafety system. The present NBF is the basis for the national sustainable biosafety system development, taking into account proposed principles of legal basis and intersectoral interaction and partnership, which is in the process of its development and formation of the national capacity building in the field of biosafety, has to be improved and adapted taking into account national needs and interests. For the time being NBF contains the following basic components:

- policy in the field of biosafety and its potential; - normative basis and regulatory regime on biosafety provision; - administrative structure and its potential; - coordination mechanism and the system on intersectoral partnership; - expert structure and its role in scientifically validated risks assessment; - system of identification, monitoring, control and liability; - information provision to the national structures on biosafety in formation of the BCH

Mechanism; - mechanism on public access to information in the sphere of biosafety and participation in

decision making. This system also includes mechanisms on non-conflictual partnership interaction of all key groups and should provide for clarity, transparency and validity and predictability of decisions taken, that could provide safety for the environment and human health, guarantee observance of ethical norms, promote public well being, development of science and technologies and comply with international norms and rules. Developed draft law “On Biological Safety” and guiding principles of normative provision of the national biosafety system serve as the basic foundation of the NBF, through formation of legal acts, regulations, instructions and other institutional documents. The system on normative and legal regulation of genetic engineering activity and transgenetic organisms turnover based on the proposed draft law of the Kyrgyz republic “On biological safety” and project guiding principles of preparation of “Regulations on Biosafety Regime in the Kyrgyz Republic” as the basic act that defines the format and procedural rules of the process on regulation

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and submission of appropriate documentation, taking into account economical situation in the country, is based on existing administrative structure and control and inspectorate services, and therefore, establishment of the regulatory regime in the country will not require additional financial resources. Establishment of competent Administrative Body, responsible for the biosafety system in the country will not require additional financial resources as well. Creation of expert structure and additional expenses on its functioning is planned to be covered at applicants’ and users expenses. Certain financial resources could be required during the creation o information provision system of obligations of the Kyrgyz republic on Cartagena Protocol (Article 23) and the mechanism on public participation in decision making arising from the obligations within the Convention on access to information, public participation and access to justice in environmental matters (Aurhuss Convention). These functions are planned to be assumed on public BCH Mechanism that could be created with financial assistance from of UN European Commission that administer the Aurhuss Convention. During recent years, due to broad international practice, accumulated through the mechanisms of mutual surveys on environmental protection, including analysis of economical indicators and systems on natural resources management conducted by the Organization on Economical Cooperation and Development, surveys on environmental conditions and protection measures implemented by the UN European Economical Commission, surveys of ecological funds conducted by the Special Working Group on implementation of Action Plan on environmental protection for Central and Eastern Europe, IMPEL Network initiative on the survey of activities on ecological control in the sphere of enforcement and success of the national systems on ecological control on the basis of analysis conducted by the representatives of countries participants of the Network on implementation of programs on environmental regulation (REPIN). Considerable experience have been accumulated on rendering assistance to countries of the region on implementation of the most progressive international practices o reformation of activities in the field of environmental protection and the national control systems as well. Since the year 2000 by these international institutions the analysis of national systems on regulation and control in the Kyrgyz Republic is conducted on a regular basis. Stating certain success in enforcement sphere and reformation of control bodies, international experts are agree on that point that main reasons of the weak efficiency in implementation of programs in the field of ecology and sustainable development, including: - weak potential of the state, local and public organizations, dealing with management, control,

monitoring and regulation in the field natural resources utilization; - absence of incentives and clearly indicated priorities, common objectives and adequate

indicators; - existing conflicts between sectoral interests and objectives; - insufficient development of the legal and institutional mechanisms for the formation of

common objectives and consensus achievement between sectors and different levels of management and parties concerned;

- limited access of the public to information, on the stage of planning and, including target groups, and participation in decision making.

In the formation of the national biosafety system there are three the most important directions of efforts on capacity building creation: - political, normative and legal and administrative potential with definition of objectives and

institutional responsibility; - scientific and technical potential of experts’ risks assessment and regulation, identification,

monitoring and control and development of forecasts on possible negative impact to the environment;

- potential of the individual level of intersectoral interaction on the basis of involvement of different target groups with formation of professional skills, behavior and maintenance of incentive mechanisms in order to increase public role in natural resources management.

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In these directions, further development of the NBF is anticipated, for the purposes of national biosafety effective management with more higher speed of development than changing circumstances of progress in the field of bio-engineering and integration into international biosafety system. There is no doubt, that for the provision of effective formation of international biosafety system and implementation of the Cartagena Protocol’s objectives, there is a necessity in cooperation between countries and support from the world community to developing countries in creation of their potential in the field of biosafety. Kyrgyzstan as a mountainous country and being the Center of origin for cultural plants and Center of genetic diversity at the same time is WTO member, and standing in special conditions of the national biosafety formation and expect essential support from the world community for whole set of measures aimed at national biosafety system creation. Present document is the result of UNEP/GEF Project implementation “Development of the National Biosafety Framework in the Kyrgyz Republic”. Representatives of state bodies, management, deputies of Jogorku Kenesh, Parliament of the Kyrgyz Republic, local administrations, NGO’s and international organizations and project experts in the field of natural resources and sustainable development were actively involved in the work on formation of the NBF. Assistance in the preparation of the NBF have been made by many participants of this process, which made its contribution not only through participation in arrangements on preparation of document, but also by useful written and oral comments. All comments received were thoroughly studied by the NBF compilers before completion of the final text. NBF compilers expresses its gratitude to all participants involved into this work, and would like to mark the following people for valuable contributions in the preparation process of the final text of NBF: Abdyrasylov Y.A., Aitmurzaeva D.H., Aldashev A.A., Arzybaev M.A., Ahmatov M.K., Ahmetov U.T., Bektemirov A.B., Burhanov A.M., Bulekbaev E.K., Bortcova S.V.,Vashneva N.S., Davydova L.N., Eletskyi A.I., Junushev A.T., Idrisov N.A., Ismanova M.A., Kachybekov U.B., Kadyrbekov I.D., Karmyshev U.A., Kamalidinova F.B., Kasymov O.T., Kocherbaeva I.D., Mansurova A.M., Musuraliev T.S., Moldogazieva K.S., Kuchuk T.E., Ostroborodova L.N., Pehota A.M., Rudenko B.N., Rustembekov O.S., Sultanalieva E.T., Sleptchenko S.S., Surappaeva B.M., Sydygalieva J.O., Toktoraliev B.A., Tumenbaeva J.T., Sharshenova A.A., Shukurov E.Dj., Egemberdiev J.B.

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Chapter 1. National policy and international cooperation in the field of biosafety

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Chapter 1. NATIONAL POLICY AND INTERNATIONAL COOPERATION IN THE FIELD OF BIOSAFETY

By the end of XX century biosafety as the monitoring system and regulations of possible negative impacts of developing bioengineering technology on human health and biodiversity and as a whole to the environment, has got global importance.

Accepted on a well-known international forum - Conferences of the United Nations on the environment and development in Rio de Janeiro (1992) in the program document «Agenda for 21 century» (UNCED, chapter 16) prospects of the further development of biotechnology and use of transgenetic organisms have been determined as special conditions for introduction: «If they are developed and applied in a rational way». By this time it becomes more and more clear, that results of genetic engineering not only promote considerably well-being of the people, in particular in satisfaction of pressing needs in food products, sustainable development of agriculture and maintenance of the system public health care services, but also to have significant negative consequences for sustainable use of biodiversity and human health if they applied in an uncontrolled and irrational manner. This dual aspect of modern bioengineering technologies has been especially precisely determined in the Convention on Biological Diversity. So, the Convention opens and promotes access to technologies of use of genetic resources by genetic-engineering methods and provides as the important element for the achievement of the purposes on preservation and sustainable use of biodiversity, provides for the transfer, on a preferential conditions, of these technologies to developing countries. Under this condition, the Parties of the Convention are called to provide development of measures for regulation, the control and to establish procedures of increase of safety on the use of transgenetic organisms, providing restriction of any possible threats to biodiversity and human health.

Taking into account worlds’ tendencies of intensive development of biotechnologies and expansions of transgenetic organisms application not for research purposes only, but also to solve certain practical tasks aimed at increase of economic efficiency in agricultural production, Kyrgyz Republic join to the world interests in the necessity of biosafety maintenance and defines as main principle in construction of internal policy - recognition of biotechnology’s potential for creation of conditions for society’s well-being growth but only under the condition of conformity to adequate measures of safety for the environment and human health. Conceptual provisions for the formation of a national policy in the sphere of biosafety have been incorporated in program documents

Formations of ecological safety and sustainable development of the country, including:

The concept of ecological safety of the Kyrgyz Republic, approved by the Decree of the Government of Kyrgyz Republic dated October 18, 1996, №332;

The program of actions till 2010 «Agenda for 21 century of the Kyrgyz Republic», approved by the Governmental Decree dated August, 2, 2002 № 411-p;

National review RIO+10 on results of promotion of the Kyrgyz Republic to sustainable development, approved by the Governmental Decree dated August, 2, 2002 № 411-p;

The scheme № 1 Biosafety Framework

(Components of the National System on Biosafety)

National policy on biosafety and its components: - - - - - - - - -

Biotechnology (bioengineering); agricultural production; Biological protection and-or quarantine; Biodiversity Preservation; Preservation of the environment; Public awareness; Production of food stuffs and/or food safety; Science and technologies; Sustainable development.

Departmental systems: - Control over the usage and turnover

of transgenetic organisms; - Monitoring of impact on human

health, environment,flora and fauna; - Implementation of measures to

guarantee the conformity to technical requirements;

- Liability on infringements (penalties)

ms for awaremparticip- Pub

to info- Pub

particidecision ecomatter

- Incpublicand quof thecontroon regLMO’turnov

Regulatory regime. Legislation,

:

General provisions: − Terms used; − Goal; − Sphere of action; − Institutional

arrangements; − General obligations. Functional provisions & procedural norms− Creation of organisms and regulation

of genetic engineering activity; − Usage and turnover; − Experimental release to the

environment; − Placing on the market/

commercialization; − import/export/transit; − decision making procedures; − mechanisms for public participation. Other elements: − transition period; − monitoring and turnover

control; − organisms identification

and the Register; − infringements and

penalties and liability; − damages compensation;− labeling and control; − confidential information

and IPR’s

National Clearing House Mechanism, that includes: - System on implementation of obligations on reports to the secretariat; - System on information maintenance of national system on biosafety on innovations in internatio

regulatory norms; - Promotion of integration of the national system on biosafety into international clearing house me- Promotion of information exchange and connection with national structures on biosafety with

supplementary multiple bodies within international system on biosafety

Mechanispublic ess and ation lic access rmation ; lic pation in on making logical s; rease of awareness alification

national l services ulation of s/GMO’s er

Administrative system: - Competent state authority,

responsible for handling of applications to obtain permission;

- Special competent authorities on regulation of risks and LMO’s/GMO’s turnover control;

- System of procedures for handlingof applications and requests to obtain permissions;

- System on interdepartmental coordination on control, monitoring, and other administrative measures

- Risks assessment; - Decision making procedures

nal

chanism;


Strategy of biodiversity preservation in the Kyrgyz Republic, approved by the Decision of the Government of the Kyrgyz Republic dated August, 3, 2002 № 524;

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•

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•

•

•

•

•

•

•

•

Concept of an agrarian policy of the Kyrgyz Republic till 2010, approved by the Governmental Regulation dated June, 22, 2004 № 465;

Concept of the national policy in the field of healthy (functional) nutrition of the population of Kyrgyz Republic for the period till 2010, approved by the Decision of the Government of the Kyrgyz Republic from December, 19, 2003 № 785;

Concept of development of Forestry branch of the Kyrgyz Republic, approved by the Decision of the Government of the Kyrgyz Republic dated April, 14, 2004 № 256;

National plan of the Kyrgyz Republic on preservation of the environment, approved by the Decision of the Government of the Kyrgyz Republic dated January, 29, 1996 № 43;

State scientific and technical program "Biotechnology" approved by the Decision of the Government of the Kyrgyz Republic dated April, 22, 2003 № 234;

Decision of the Government of the Kyrgyz Republic dated August, 13, 2003 № 511 «On the approval of priority directions for the development of science and the List of critical technologies on priority directions for development of science in the Kyrgyz Republic for 2003-2005».

Great importance for the achievement of goals for global system on biosafety creation has been attached to the international cooperation on capacity building the field of biosafety in developing countries which have the limited opportunities. In this respect great importance has been attached to Cartagena protocol on Biosafety, entered into force in 2003. The Protocol promotes the international cooperation with a view of rendering assistance to developing countries on human resources development and organizational potential in the field of biosafety. The Protocol is directed to the creation and increase of efficiency of national systems on biosafety among different countries by means of creation of rules and procedures on safe transfer, processing and use transgenetic organisms and regulates not only transboundary movement, but also use and release of suitable for use safe transgenetic organisms inside each country. The Protocol encourages the efforts of the Parties directed on scientific and technical professional training and rendering assistance in transfer of technologies, and provides creation of the mechanisms for dialogue and cooperation for the global system on biosafety creation within the framework of the general BCH stipulated by the Convention on Biological Diversity.

For the formation of the national policy in the field of biosafety, conceptual components fixed by the Cartagena Protocol has special importance, including:

Possibility to have a choice: the Party itself makes the proved decision on import and use of transgenetic organisms with broad participation of all parties concerned in expert risk assessment procedure before final decision-making;

Safety provision: the national system on biosafety creates tools and methodical bases for regulation of risks and potential consequences of transgenetic organisms release;

Capacity building: each Party independently or with assistance of the BCH Mechanism undertakes necessary actions on development of human resources potential and their professional training to solve certain technical tasks on identification and expert risk assessment during the process of making scientifically proved decisions;

Maintenance of stability: the Party independently through the established system of procedures makes of the decision and provides measures on preservation of sustainable development on the basis of safe technologies;

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Implementation of provisions , rules and procedures of Cartagena Protocol provides to each Party non-conflictual interaction at the international level and introduction of safe and effective technologies;

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Guarantees opportunity to express the opinion provided to each Party, thus each Party creates necessary conditions in order to express their own opinion.

The general principles and the minimal supervising rules for corresponding structures of the system on biosafety directed on effective cooperation and accepted measures adequate to risks, and include a number of basic principles:

Principle of coordination;

The precautionary approach at all stages of risks assessment and decision-making;

Principle of acceptance of safety measures with careful scientific approach to substantiation of decision-making in view of the international experience and scientific data;

The principle of a consensus at the international level in acceptance of measures deal with global environmental problems obliges the Parties to cooperate on creation of favorable and open international economic system – which is the bases of sustainable development in all countries;

Principle of public participation - Parties create necessary conditions for public participation at the stage of consideration of applications for use of technologies, and at a stage of acceptance of globally significant decisions.

The policy on biosafety in the Kyrgyz Republic only starts to be formed. In recent years positive results are achieved and the certain experience is accumulated in formation of a policy, principles and legislative bases environmental protection; good bases is created in specifications on sorts testing and protection of breeders rights; according to the international standards and requirements the legislative base on phytosanitary is created.

Kyrgyzstan recognizes importance of development of National structure on biosafety as one of components for creation and maintenance of effective international system on biosafety, thus Cartagena Protocol its provisions is the international basis for the maintenance of this system. Proceeding from the necessity of broad and effective international cooperation with a view of environmental protection, biodiversity preservation and maintenance of biosafety in the territory, the Kyrgyz Republic actively participated in all international initiatives on environmental management, genetic resources and human health and makes efforts on the use of interaction potential with international community on sustainable development of the country and economy. One of the important purposes of the policy on biosafety is the creation of mutually agreed actions of all corresponding competent authorities, all stakeholders concerned and the general public. The basic priority is the development of the potential, training of experts and creation of adequate mechanisms for information within the system on biosafety.

In structure of NBF proposed main principles of the policy that are based on the establishment of regimes and measures on prevention and regulation of possible negative impacts to the environment, and especially on biological diversity and human health as well as the maintenance of guarantees of safe use and application of bioengineering technologies.

Formation of a policy in the field of biosafety includes a complex of interconnected components which make strategic potential of maintenance of national regimes on biosafety and as a whole are directed on development and adaptation to the international standards:

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Table 1.1.

Strategic components Potential of development Measures on overcoming barriers, restrictions and

difficulties

1. Definition and estimation of priorities

Programs on sustainable development of the country determines priority directions

Deep and scientifically validated evaluations of measures efficiency and economical benefits from investments of human resources and material resources

2. Partnership and international cooperation

Transfer of modern technologies is conducted on the basis of international cooperation and the partnership on modern use of genetic resources

It is necessary to expand international cooperation in the framework of WTO, UNEP, WHO, UNIDO, MCOP, FAO

3. Determination of needs taking into account economy of resources

Needs in resources to solve certain national matters on sustainable development and security maintenance are supported taking into account global importance

Needs has to be relevant to resources and only within the framework of priorities designated there is a possibility for effective support from international community

4. Legislation and establishment of regimes on safe use of technologies

Existing legislation represents an important advantage for further development taking into account introduction of the necessary legislative innovations

All normative basis of the regimes introduced should not create unreasonable barrier to comply with international commitments as well as secure development of commerce and business within the country

5. Researches and scientific potential

Creation of a scientific potential and sufficiently high level of scientific researches development has a great importance for sustainable development and improvement of economical situation on the basis of technological achievements

State support of priority scientific researches, training of highly qualified staff and making competition on the results of the efficiency of science to the economy of the country

6. Administrative structure and the mechanisms on decision making

Existing structure of management and control could serve as the basis for development and regulation of safe use of modern technologies achievements

The most important legislative input to the existing structure of management has to be determination of the Unified competent authority which is responsible for coordination of all regime on biosafety in the country

7. Coordination and internal cooperation

Coordination of efforts and measures taken on environmental protection provides decrease of costs

Cooperation between institutional controlling authorities and transparency of measures has an importance for

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and has a potential for further development

unconflictual functioning of the entire biosafety system

8. Impact assessment and regulation of risks from use of modern technologies achievements

Composition of experts has a possibility to use international experience on risks regulation and improvement of skills through training

System on operative risks assessment has to be improved on a regular basis to maintain reliable security of the country

9. Participation of parties concerned in the process of control strengthening within established regime on biosafety

Participation of all parties mainly determined by new legislative inputs and their subsequent implementation

Participation of parties and control regime improvement could only be provided through expressed interest and stimulation of all process participants, clear understanding of goals and tasks within biosafety framework

10.Professional resources and qualification of staff

Within the control system there is a institutional potential for development

The level of qualification potential requires organization of different teaching programs and increase of requirements to professional skills of the staff of all services deal with biosafety matters

11. Identification within the system on biosafety and monitoring of consequences of use of biotechnology achievements

Development of scientific potential and provision of control services with equipment with international standards

Difficulties for identification one of the main barriers to deal with biosafety matters, and they could be solved only through support from international community

12. Public participation in decision making on important ecological issues

Expression of the opinion and viewpoints with regard to processes on use of resources and conditions of the environment is the essential right of every citizen

There is a need in development of transparent procedures that provides public participation in decision making process on environmental protection issues

13. Ecological education and public awareness

Ecological accuracy – is the main important component of healthy society, which is mainly determines sustainable development of the country

Transparency of measures taken and public awareness has to be accompanied by explanation of all controversial matters on use natural resources and environmental protection

14.Information exchange among parties concerned and the role of subsidiary bodies of international agreements

In the system of international agreements in the field of environmental protection and sustainable development an important role plays international interaction of different subsidiary bodies of the Convention and Protocols which are used for

Potential for the promotion by international bodies for the formation of national development programs and biosafety system is very efficient and the ways how to solve these matters is determined by the quality of this interaction

18


time being not in full capacity

15. Financial resources and measures of stimulation of programs on sustainable development and implementation of modern technologies

Resources of many countries are limited and the formation of the international system on biosafety in modern conditions depends on mutual efforts of all countries

Creation of a reliable system on biosafety could only be possible in case of close cooperation and support from developed countries as well as effective work of identification and expert labs and monitoring stations

16. Attraction of the international BCH mechanism to support reliable system of national biosafety

BCH mechanisms is effective way to support national structures in monitoring, risks assessment and expert analysis of national program’s outcomes

Ability to organize interaction with BCH mechanisms during the implementation of programs aimed at development of the country is the necessary requirement to authorities responsible for the implementation of national projects and programs o sustainable development

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Chapter 2. Framework of Cartagena protocol on biosafety in national system of biosafety

Chapter 2. FRAMEWORK OF CARTAGENA PROTOCOL ON BIOSAFETY IN NATIONAL

SYSTEM OF BIOSAFETY

2.1. Normative base and its conformity to the NBF

•

The normative base existing in the Kyrgyz Republic (Survey, chapter 8) does not reflect necessary legal aspects of biosafety regulation, including control, bioengineering activity on genetic manipulations, creation, transboundary movement, LMO’s/GMO’s used as the foodstuffs, feed or for processing in the local enterprises which, probably, are already imported from neighbouring countries. Actually, there is also a possibility to have in the country potato seed material from Tadjikistan, soya bean from Uzbekistan, Kazakhstan and China. The special concern is caused with delivery in 2004 from China of apple trees with unknown origin to the Central Asian Center of origin for cultural varieties, including apple tree.

Legal basis of Kyrgyzstan cannot be used as a tool to regulate bio-engineering activity, creation of LMO’s/GMO’s, their movement, processing and use in the closed systems and in processes of introduction. There are no specifications on safety of microbiological industrial processes, as well as norms to regulate activity connected to the use of LMO’s/GMO’s, including transboundary movement. There is no state registration and register of LMO’s/GMO’s as well as established methods for risks assessment, use, state control over biosafety matters, including customs control and zones of genetic safety.

Proposed NBF and national structure on biosafety are based on the international principles and regulatory mechanisms on biosafety which are fixed in Cartagena Protocol on Biological Safety and in the UN Convention on Biological Diversity ratified by Kyrgyz Republic. These supervising principles and positions have formed a basis for creation of the national legislation on regulation of biosafety (the Appendix II).

In the Kyrgyz Republic it is offered to provide normative regulation of the turnover of living modified organisms through NBF whre special norms are provided for, including procedural norms of applications processing, risks assessment, public awareness and decision-making. Prepared draft law “On biological safety”, aimed at development of processes on formation of biosafety national system, at present time is on stage of public consultations. The basic purpose of the given Law is creation of a legal basis for regulation of LMO’s/GMO’s turnover on territory of Kyrgyzstan, creation of the mechanism of the state control over activity on creation of transgenetic organisms and their use in the industrial and economic purposes and risks assessment procedures as well as creation of conditions providing participation of the public in decision-making (the Appendix II).

Development of the relevant legislative basis is a complex and long-term process. For the period of development, concordance and approval of all normative complex on regulation of LMO’s/GMO’s in the country, Kyrgyzstan will apply provisions of the Protocol, since legislation of the country stipulates the mechanism of use of the international norms in case of absence of the national legislation. Basis for decision-making at the first stage will also be provided by Cartagena Protocol and existing legislation in the field of environmental preservation, phytosanitary control, the control over the biodiversity protection, use of seed materials, standardization and protection of consumers rights.

Taking into account the current situation in the country and absence of the reliable regulatory mechanism, the most important tasks at the first stage of formation of the National system on biosafety are the following:

Adoption by the Parliament “Jogorku Kenesh” of the Kyrgyz Republic of the Law «On biological safety»;

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Approval by the Government of the Kyrgyz Republic of Regulations on Interdepartmental Coordination-Advisory Council (Commission) and appointment of its members;

Development and entering of mendments and additions into existing laws and departmental statutory acts;

Development according to substantive provisions of the Law and approval by the Government of the Kyrgyz Republic regulations on Bosafety Regime;

Preparation of supervising documents for departments and the controlling authorities competent in sphere of LMO’s/GMO’s regulation, including «the Methodical Manual for tests and experts’ risks assessment», development of national standards and methods on transgenetic organisms identification;

Development of interdepartmental guidelines and interaction mechanisms in decision-making process, monitoring and the control over the LMO’s/GMO’s turnover..

The analysis of conformity of the substantive provisions of normative regulation of LMO’s/GMO’s turnover incorporated in a draft law, supervising principles and provisions of an NBF of Cartagena Protocol is carried out inaccrodance with special verifying list of indicators proposed in Meeting of Parties, in Recommendations З/5 «Handbook on introduction of the provisions of Cartagena Protocol on biosafety ». Given analysis is attached to Annex III.

Draft law provides for the regulation of the following activities, including:

Genetic engineering, genetic manipulations and creation of transgenetic organisms, their test and release to the market for use;

Import for research purposes and genetic manipulations;

Use of included into the Register of LMO’s/GMO’s in the closed systems;

Import for use in closed systems LMO’s/GMO’s (1-st and 2-nd risk level);

Field trials of created in the country LMO’s/GMO’s and risks assessment of their release to the environment for inclusion into the Register and release on the market for the subsequent introduction;

Import for tests and risks assessment of LMO’s/GMO’s intended for use in closed systems (3-rd and 4-th risk level);

Import for introduction for the inclusion into the Register and release to the market (seed material);

Import for field trials and the subsequent introduciton of LMO’s/GMO’s to the environment with their inclusion to the Register and release in domestic market (in accordance with PIC procedure);

Introduciton of LMO’s/GMO’s and creation of industrial basis for their safe cultivation with subsequent release of derivatives from them products to the the market;

Import of derivative products from LMO’s/GMO’s, including intended as food, feed or for processing at local enterprises

After the completion of the procedure of public consultations and acceptance of the Law on biological safety by the Parliament- the legislative body of the Kyrgyz Republic will reconsider and harmonized existing laws and relevant legal acts of departments, including departmental normative documents directly related to biosafety maintenance in the country (Article 33 of of the draft law «On biological safety»). During implementation of the Law and formation of the national system on biosafety corresponding instructions, manuals, recommendations, technical norms, standards and

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procedural rules, as well as duties and legal maintenance of the National control service and regulation of transgenetic organisms will be prepared.

The scheme 2 L i v i n g m o d i f i e d o r g a n i s m s t u r n o v e r

P r o d u c e r

PIC

PIC

L M O ’ s c r e a t i o nImport for researches and

manipulations

Tests and experts’risk assessment

(report) LMO’s register

П о а т ел ь з о вU s e r

LMO-PFЕ

I m p o r t e d L M O ’ s

Import from

external market

Expert risk assessment (report)

Field trials and experts’ risk assessment

Reprocessing of wastes and destruction

LMO’s manipulation and creation

Export Commercialization

and Market Import

Internal secondary market of products

Consumer Use for introduction

Utilization of wastes

Use in closed systems

Processing on local enterprises

LMO Register

LMO Register

Field trials

PIC

External consumer

According to requirements of the Convention on a Biological Diversity and Cartagena Protocol on biosafety participation of the Kyrgyz Republic in the BCH Mechanism will be provided. In particular, within the framework of formation of the National structure on biosafety on the central portal of the website of the National system on biosafety all legislative documents, amendments and additions to them will be placed. Besides it, with support from UNEP/GEF and Cartagena Protocol Secretariat, the public national BCH Mechanism and an information exchange will be created. It will provide access to legislative - normative bases of the country and to procedures of decision-making that involve general public in the country, as well as all organizations concerned, including foreign. The national BCH mechanism along with the BCH Mechanism of Cartagena Protocol; (Article 20) could also organize cycles of educational programs and public school - courses for improvement of qualification of expert structures and users of new technologies products.

In the field of international cooperation and exchange of experiences Kyrgyzstan will use the best international practices of other countries to improve the legislative and normative documentation through the international cooperation within the framework of Subsidiary bodies (Article 30 of Cartagena Protocol), including regional trainings, workshops, and also the advisory assistance to the countries of Central Asian region.

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Being the Party of certain intergovernmental agreements, and having a number of significant advantages of biodiversity with global importance, including Centers of Origin for certain cultural plants and the Centers of sorts diversity obtained through national selection, Kyrgyzstan aspires to develop and maintain the international cooperation in the field of formation of reliable regional system on biosafety and makes significant efforts on acceleration of this process and creation of own reliable system of biosafety and regulation of LMO’s/GMO’s turnover. 2.2. Administrative structure (functions and regulatory regime)

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According to Article 19 of Cartagena Protocol on biosafety the draft law of the Kyrgyz Republic «On biological safety» stipulates establishment under the Government of the Kyrgyz Republic of the Interdepartmental Coordination-Advisory Council (Commission) on biosafety – which is functioning, in accordance with Article 7 of Law, as Competent Authorized Body and executes the following duties:

Promotes state policy in all branches related to safe use of bioengineering technologies;

Carries out consultations of governmental bodies and services on biosafety matters;

Carries out functions of the Competent Authorized Body (SAAB) and coordinates activity of the Special Authorized Administrative Bodies on the control over the Biosafety Regime;

Develops drafts of normative-legal acts on bioengineering technologies and biosafety matters;

Develops criteria, rules and procedural mechanisms on experts’ risks assessment, processing of Applications and granting Permissions, registration and maintaining the Register of Living modified organisms, their classification on risks levels, handling, release and introduction of transgenetic organisms;

Establishes risk levels for activity and individually for each LMO on the basis of tests and expert assessments, taking into account expert recommendations and the guidelines developed by relevant international organizations;

Coordinates and improves the control system in the field of biosafety;

Grants Permissions or refusals on results of Applications processing and requests on the basis of experts’ decisions on genetic engineering activity, use of living modified organisms in the closed systems, introduction to the environment and transboundary movement of living modified organisms;

Supervises creation of information databases in Special Authorized Administrative Bodies (SAAB) and their interaction with BCH Mechanism on Biosafety;

Participates in collaboration with SAAB in representation of interests of the Kyrgyz Republic as the Party of the international agreements in sphere of biosafety and a biodiversity;

Takes the responsibility for performance of obligations with regard to reports and information exchange resulted from the international agreements on biosafety.

Regulation of activity on creation, use, transboundary movement, release to domestic market of derivative products, as well as monitoring and the control over LMO’s/GMO’s turnover and recycling of dangerous waste products from bioengineering activity are assigned to Specially Authorized Administrative Bodies. Normative duties of these bodies are provided for in the Article 8 of the Law, including:

1. Council on National Security carries out the control over activity on LMO’/GMO’s creation of 4-th risk level and control the situation and carrying out functions on environmental

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•

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protection in case of global accidents, that could nagatively impact the territory of large regions, including neighbouring countries.

2. The State Agency of Science and Intellectual Property:

Regulates research activities on LMO’s/GMO’s creation and carries out examination of Applications in this sphere, including LMO’s/GMO’s import for research purposes and manipulations;

Μaintains the Register on researches on organisms creation of 3-rd and 4-th risks level and the Register of all allowed LMO’s/GMO’s for use in territory of the Kyrgyz Republic;

Supervises conducting researches in laboratories through the journals where the records of all R&D works are contained.

3. The Ministry of Ecology and Emergencies:

Supervises through its services on environmental protection and safety of production processes of all researches and use in the closed systems and in case of introduction;

Participates in all expert risks assessment and maintain the Register of experts in the field of environmental protection.

4. The Committee on Incomes under the Ministry of Finance carries out the customs control.

5. Ministry of Health Care:

Supervises through the services on sanitary-and-epidemiologic control, condition of food stuffs, safety of activity on creation and use of LMO’s/GMO’s and maintain the Register of Experts dealing with risks assessment on human health;

Carries out necessary tests on safety of LMO’s/GMO’s, used in foodstuff;

Handling of Applications on requests on the use of LMO’s/GMO’s in the closed systems for the purpose of synthesis of medical products, genetic theraphy or genetic diagnostics.

6. The State Forestry Service:

Supervises regime on prohibition of LMO’s/GMO’s use in zones of genetic safety and carries out monitoring of introduced agricultural crops’ potential impact, including fruit crops on wild-flora in zones bordering these fields;

Processing the Applications on LMO’s/GMO’s introduction for the purpose of forest-growing and maintain the Register of experts dealing with biodiversity protection of a (mainly, genetics, geobotanics, forestry specialists, entomologist, etc.).

7. The Ministry of Agriculture, Water Resources and Processing Industry:

Promotes execution of state tests, registration and risks assessment of LMO’s/GMO’s on sorts’ diversity, and also an experts’ assessment of preparations on basis of LMO’s/GMO’s, implemented into production for the protection of plants;

Supervises through veterinary and phytosanitary control, safe use and movement of LMO’s/GMO’s, carries out monitoring of introduced LMO’s/GMO’s and quality of products produced;

Processes Applications on use in the closed systems at the enterprises that produce cheese, beer, dairy products and synthesis of food additives, as well as for the purpose of introduciton GM-crops, cattle breeds, fishes, ornamental plants and animals;

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• Maintain the Register of LMO’s/GMO’s, introduced in agricultural production of the

country, as well as the Register of experts dealing with risk assessment as for impact on vegetation of agrocoenosis and safety of all production processes at the enterprises of the food-processing industry and introduciton of LMO’s/GMO’s.

8. The National Academy of Sciences coordinates all scientific researches in the field of genetic engineering and participates in all examinations on risks assessment of all LMO’s/GMO’s, including imported.

9. The authorized body on technical regulation coordinates activity on preparation of normative documents on biosafety and observes conformity with international standards.

10. The national institute of standards and metrology provides standardization taking into account international standards with regard to LMO’s/GMO’s and the processes on their safe use.

Structure of Interdepartmental Coordination-Advisory Council (Committee) consists of representatives of the ministries, departments, organizations and other state structures providing biosafety in the country. Representation, order of representation, terms of delegation and regime of its work are determined by Regulations on Interdepartmental Coordination-Advisory Council (Commission) on the biosafety, approved by the Government of Kyrgyz Republic. The given administrative structure quite reliably could provide coordination of preventive measures and the control over the regime on biosafety, as well as operative and effective processing of Applications and decision making providing a high level of safety in operations on LMO’s/GMO’s.

Suggested by the NBF regulatory mechanism as a whole is based on WTO standards, including SPS agreement and GATT, Codex Alimentarius, phytosanitary measures ICPM (UPOV), International Managament on Epizootic norms, specifications of ISPP, guidelines of UNEP-ITGB and other international norms of the legislation on biosafety which are regulated by Cartagena Protocol to the Convention on Biological Diversity. For Kyrgyzstan as a the Party to the Convention and the Protocol, as well as other Agreements these international principles are the basis of regulatory regime in the field of biosafety.

Draft law of the Kyrgyz Republic «On Biological Safety» regulates activities connected to LMO’s/GMO’s turnover, including:

Table 2.1.

№

Regulatory regime

on activity

Relevant articles and

chapters of the draft law

Format, procedure, order

and terms, provided for in the

regulations I.Bio-engineering activityon creation,testing,release to the market with inclusion to the

Register of LMO’s/GMO’s 1. Right on activity and regulation of the

process on Permissions granting on bio-engineering activity

5; 9(4); 10(5); 14(1); 9(7)

Format of the Application, order and terms of consideration

2. Requirements as to the risks levels of activities and created organisms

4(1); 10(3); 17 Annex to Regulations 4(2); 4(3)

3. Requirements on regime of tests and expert assessments

11(1); 12 Manual 9(1)

4. Rules of inclusion to the Register of 11(6); 13(1); 18 Procedure 13(1)

25


LMO’s/GMO’s and commercialization

5. Control of production processes and the Journal of R&D works records

17 Typical regulations on commissions on security issues and Journals of R&D works records

6. Requirements on activity with organisms of 3rd and 4th risks level

4(4); 26(6); 29 Control order

7. Control over the Biologically-Social Emergency Situation (BSES)

26(6) (7) Procedure on applied measures

8. Protection of intellectual property rights 13(2); 27(4) Additions to legislation

II. Use for commercial purposes and turnover

9. Right o nactivity and the order of Permissions complication

5; 9(5); 10(3) (5); 14

Procedures and terms of consideration

10. Regulation of activities on risks level for closed loop system

4(1); 18(3) Control order

11. Security of production processes 14; 17; 29 Typical regulations on Commissions at Enterprises

12. Limitations from release to the environment

12; 18(3); 19; 20(3); 26

Control procedures

13. Regime on field trials and their expert assessment

11(2) (4) (7) Manual on risks assessment

14. Inclusion to register and commercialization of plant varieties

13 Procedures

15. Import regime on introduciton according to PIC procedure

20(2) Procedures and terms of consideration of applications

16. Order for reconsideration, change of decisions and security control

24 Procedures in regulations

17. Requirements on transportation of created in the country LMO’s/GMO’s

27; 26(9) Format and Procedures

18. Reporting order on results of introduction 20(6) Format for reporting

III. Import/Export/transit and movement 19. Import regulation and requirements to the

security of LMO’s/GMO’s 3; 10(3) (5) Fromat clarification

and decision making procedures

20. Requirements to the accompanied documentation

21; 22 Documentation (format)

21. Terms and conditions for transportation and labelling of LMO’s/GMO’s

21(4); 27 Format and rules

22. Customs control 27(3) Additions to the law

23. Movements control 29 Rules

26


24. Illegal transboundary movement 25 Additions to the

Customs Code IV. Liability and reparation of damages

25. Liability for the infringement of law 9(6); 11; 12(5); 26

Making additions to existing legislation

26. Reparation of damages 30(3) (4) -«- 27. Protection of confidential information 28(5); 30(5) Inclusion of

additions to legislation

28. Dispute settlement procedures 31 -«- V. Public awareness and the order of comments processing

29. Public access to information databases 7, 3 Access order 30. Copies of Applications 9(2); 28(1) Typical format 31. Information through mass media 28(2) Order of

publications 32. Public comments and their observance 13(3); 28(3) Terms of comments

receipt 33. International information exchange

through the BCH Mechanism 32 Regulation on

National BCH Mechanism

34. Reports on implementation of norms of Cartagena Protocol on Biosafety

32 Lists of reports

2.3. Coordination mechanism and its functions

Orientation of a policy towards the biodiversity preservation and maintenance biosafety in the country, coordination of activities of ministries, departments and local bodies of the government on matters related to the maintenance of biological safety according to Article 6 of the draft law «On Biological Safety» is assigned to the Government of the Kyrgyz Republic. The given functions are carried out through the

27


The scheme 3 Management and coordination of activities of the state structures in sphere of biosafety of the Kyrgyz Republic

28

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S t a t e C o n t r o l S e r v i c e s

S t a t e E x e c u t i v e B o d i e s

C o m p e t e n t A d m i n i s t r a t i v e B o d y

P o l i t i c a l A u t h o r i t y

Interdepartmental Coordination-Advisory Council (Commission)

S p e c i a l C o m p e t e n t E x e c u t i v e B o d i e s o n b i o s a f e t y r e g u l a t i o n

Ministry on Health Care

National Institute of standards and metrology

Sanitary and Epidemiological

Services

Dep

artm

ent o

f eco

logy

and

nat

ural

re

souc

es

epar

tmen

tio

n an

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atio

n

Stat

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ice

on th

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tion

of fl

ora

and

faun

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tion

on

quar

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Dep

artm

ent

on

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mic

f pl

ants

Dep

artm

ent o

n ve

teri

nary

Stat

e Se

ed

Insp

ecto

rate

C o o r d i n a t i o n o f a c t i v i t i e s o n b i o s a f e t y

State inspection on industry securiy and

control in mountaineos regions

Sector of licenses and

contracts

Law Department

Testing laboratories

State Forestry ServiceMinistry on Agriculture, Water Resources and Processing Industry

lant

s

Ministry of Finance

ontro

l Ministry on Ecology and

Emergencies The State Agency of Science and

Intellectual Property

Government of the Kyrgyz Republic


•

•

•

•

•

Competent Authorized Body on Biosafety – Interdepartmental Coordination Advisory Council (Commission) which comprise plenipotentiaries of the administrative board of the state bodies providing regulation of activities on use, transboundary movement and control over the LMO’s/GMO’s turnover on the territory of the Kyrgyz Republic. All bodies dealing with biosafety matters included in the state system are carry out functions of the Special Competent Administrative Bodies according to Article 7 of draft law on LMO’s/GMO’s turnover. Coordination of the regime on biosafety by the Interdepartmental body uniting plenipotentiaries of all structures of management, is carried out through procedures of Applications processing, experts’ risk assessment, revealing of the safety level of LMO’s/GMO’s and Permissions granting to activity on their use with Instructions, and if necessary with acceptance of specific security measures (the Scheme 3).

As the subsequent actions, in addition to incorporated in Regulations on biosafety to supervising principle of regulation of all biosafety regimes for all complex of activity on use of LMO’s/GMO’s and their turnover, including procedures on Applications processing, Permissions granting, entering into the Register, commercialization of LMO’s/GMO’s uses, it will be necessary to prepare relevant manuals as interdepartmental agreements based on the international norms in the field of coordination of accepted measures and control functions between all state structures concerned, including:

An interdepartmental coordination manual on Applications processing, scientific validity of risks assessment, the order of attraction and payment of experts, use of a databases of international bodies on biosafety, public awareness rising on the results of experts’ assessments and prepared Decisions;

Instructive interdepartmental agreements on using data of Registers, control over the arrangements and monitoring, of both, production processes as well as use for introduction, control over the movement and observance of biosafety regime over release on to domestic market of derivatives from LMO’s/GMO’s production;

Improvement of the mechanism on public awareness, labeling and creation of the public national BCH Mechanism, as auxiliary public structure on work with the population and formation of uniform information system in the sphere of biosafety;

Interdepartmental agreements on biosafety maintenance in case of biologically social emergency situations and control improvement on the activities pertained to LMO’s/GMO’s 4th risk level. 2.4. Expert structure, its potential and a role in risks assessment Expert assessment of security of activity on researches, creation, testing, movement and use of LMO’s/GMO’s, as well as direct safety assessment of LMO’s/GMO’s and their subsequent determination of risk level are carried out by Expert Groups or the Expert Commissions created on time period of examination from the list of specialists registered in the registare taking into account their qualification and the purposes of examination.

Registers of experts are maintained by Special Competent Administrative Bodies taking into account qualification of experts dealing with target directions of activities of these bodies:

Ministry of Health Care maintain the Register of Experts in the field of human health care on different spheres (allergists, epidemiologists, microbiologists and toxicologists) with observance of examination features on use of LMO’s/GMO’s pertained to 3-rd and 4-th risk level in microbiological synthesis;

Ministry of Ecology and Emergencies - the Register of experts dealing with safety of processes of biological synthesis and labour security, environmental preservation from possible negative impact of waste products from microbiological synthesis and release of LMO’s/GMO’s, including 3-rd and 4-th risk level;

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•

•

•

•

Ministry on Agriculture, Water Resources and Processing Industry - on a speciality ofphytosanitary, veterinary control, breeders dealing with protection of sorts biodiversity in agrocoenosis and experts in the field of biotechnology and chemical protection, as well as entomologists on prevention of negative impact due to pollination with cultural flora and and the possibility of transgenetic weeds occurrence;

State Forestry Service maintain the Register of experts on a biodiversity protection, including geneticist, botanist, entomologists, soil scientists, hydrobiologists, microbiologists, virologists and other experts - scientists of system of the National Academy of Sciences, scientific institutes and higher educational institutions.

The international norms on scientific validity and demonstrative expert decisions (Article 15 of the Protocol) put forward special requirements to qualification of experts. In the global practice during the use of LMO’s/GMO’s significant experience is accumulated with regard to trasgenetic organisms risks assessment. In fact there is no any permissions granted with regard to release to the market without validity of safety of these organisms. The order of carrying out examinations (Article 12.1) obliges experts widely use expert decisions for imported LMO’s/GMO’s (Reports), accompanying organisms in case transboundary movement. Necessity of the precise scientific validity for expert assessments (Articles 12.1, 12.6 Laws) should be marked in «Methodical Manual for tests and expert assessments» to exclude amateurish conclusions or assessments based more on intuition and conjectures, than on laws of genetics. Kyrgyzstan is a WTO member and any forcible decisions can be recognized as discrimination barriers that will negatively be reflected in image of the country.

Tests has to be conducted in accordance to methodical criteria for risks assessment (Annex IV):

In the closed systems for all newly created LMO’s/GMO’s with the analysis of stability of genetic constructions, pleiotropic effects, impact on human health and products received as a result of synthesis or processing of these organisms and economic efficiency of their introduction into production - examination is carried out by the Expert Group which is also specifies a risk level on use of these organisms;

At introduction in case of field trials special attention would be paid to the impact on biodiversity, including possibility of pollination crossings with wild and cinatrophic fauna and flora, as well as impact of the vegetative rests on ecosystems of agrocoenosis. Physicians carry out researches according to impact risks on human health of both LMO’s/GMO’s as well as derivative products. The important component of expert assessment during field trials is the definition of agronomical, technological value and economic efficiency of LMO’s/GMO’s introduction to agricultural production. Expert risk assessment during field trials is carried out by the Complex Experts Commissions with attraction of expert – scientists from different spheres of science.

Expert assessment of use for commercial purposes in the closed systems of LMO’s/GMO’s microbiological synthesis, including imported transgenetic organisms, and also use of derivative products as the food, feed or processing, is carried out basically as a result of the analysis of materials of experts’risks assessment which have been conducted at release of LMO’s/GMO’s on the market, including foreign countries. In doubtful cases examination of safety of these organisms and their derivative products, first of all, on allergenicity is carried out, thus all estimations of risks including examination of tests materials, should be examined in a context of the risks caused by unmodified parental organisms (Article 12.3 of the Law).

As a result of experts’ risk assessment will serve the Report with scientifically proved analysis conducted by researches, and also materials of the examinations which have been conducted by foreign experts and materials of the international information system in frameworks of Codex Alimentarius, ICPM (UPOV), UNEP-ITGB, INCSB, ICGEB and the BCH Mechanism. These data at

30


•

•

•

the initial stage of formation of expert system will have paramount value, as in Kyrgyzstan there is an insufficient capacity (especially in genetics, microbiology, genetic engineering and molecular physiology and so forth) and absence of qualified personnel. In this connection the primary goal of formation of expert system is the training of qualified personnel and development of training programs in the field of genetic engineering (bioengineering).

The report prepared as result of experts’ risk assessment on use of LMO’s/GMO’s forms the basis (Article 11.6 of the Law) for revision of transgenetic organisms’ risk level, approved by examination and admitted for use in Register of LMO’s/GMO’s and release of these organisms on domestic market for commercial use. On the basis of the Report containing materials of experts’ assessments, Special Competent Administrative Bodies (SCAB) prepares Decisions on the basis of which Interdepartmental Coordination-Advisory Council (Commission) (ICAC) could grant Permission to the user (the Scheme 4).

The basic requirements to during the tests, order of experts risk assessment and its principles, qualification requirements to experts, the order and conditions of reference to the certain risk level transgenetic organisms, the order of conducting Registers ЖИО/ГМО, their identification and the order of certificates granting,, actions of preventive protection and a safety depending on risk level, procedures and terms of examinations with Instructions are defined by Regulations on biosafety regime taking into account norms of the Law.

As the subsequent actions, in addition to incorporated in Regulations on the biosafety regime principles, requirements and the order of biosafety maintenance, ICAC in collaboration with SCAB will develop the Methodical Manual for Tests and Experts’ Risk Assessment» in which typical techniques to conduct analyses and risks assessment will be presented, methods of their preventive regulation, as well as scale of risk levels for known transgenetic organisms will be developed. 2.5. Monitoring system and responsibility for infringement of biosafety regulations Into the monitoring system on use of transgenetic organisms are included:

Commissions on security at the enterprises and laboratories during genetic engineering researches with recombinant molecules of DNA and LMO’s/GMO’s creation, and also at the enterprises of molecular synthesis with use of transgenetic organisms of 2nd and higher risk levels (Article 17.1 of the Law)

Laboratory and departmental journals for registration of works on manipulations with the genetic structure, including viruses and bacteria. In addition there are certain works that also registered, the right on which is provided by licenses, on creation of transgenetic organisms of 3rd and 4th risk level by the State Agency of Science and Intellectual Property (Article 17.2 of the Law);

Control and inspection services of all SAAB (the scheme 3) which functions are determined by Article 29 of the Law.

The accepted decisions opening access to use of transgenetic organisms, should be supported with monitoring mechanism and the control not only over performance of the preventive measures stipulated by the Instruction, but also over all complex of LMO’s/GMO’s turnover irrespective of any risk level. Plans of management developed by the User are obligatory for him, but as a whole in system on transgenetic organisms turnover, great importance is attached to monitoring and control over all LMO’s/GMO’s, including of those that are recognized as absolutely safe, without having neither Instructions, nor Plans on risks regulation.

Control over the LMO’s/GMO’s turnover, including conditions on normative obligations of the User, as well as performance by the User of risks regulations within the system on biosafety should be carried out and improved according to results of monitoring and united efforts of all state control

31


•

•

•

•

•

•

•

•

•

•

structures having direct duties connected with human health, biodiversity and environment preservation.

According to the NBF the national control and monitoring system and general conditions on biosafety will be provided through Specially Authorized Administrative Bodies:

State Agency of Science and Intellectual Property carries out the control and coordination of bioengineering researches referred to 3rd and 4th risk levels, and also supervises comercialization of transgenetic organisms through the Registers of LMO’s/GMO’s.

Ministry of Ecology and Emergencies supervises environmental protection against negative impact of release and introduction of transgenetic organisms, and also carries out the control over the safety of technological processes and works at enterprises of microbiological synthesis;

Committee on Incomes under the Ministry of Finance carries out customs control and in collaboration with services on veterinary, phytosanitary and sanitary-and-epidemiologic control supervises transboundary movement of transgenetic organisms;

Ministry of Health Care supervises safety and quality of food products, regulates and establishes hygienic norms on safe handling with transgenetic organisms and safety of derivative products;

State Forestry Service provides control in territories adjoining to agrocoenosis, control and monitoring of consequences due to release and potential impact on biodiversity of transgenetic organisms and supervises security in stricly protected areas, as well as in zones of genetic safety in places of dwelling of wild relatives of cultural plants;

Ministry of Agriculture, Water Resources and Processing Industry provides veterinary and phytosanitary control over the transgenetic organisms’ movement and observance of security rules and control of production processes on the enterprises of food-processing industry and in agricomplexes, and also supervises and carries out monitoring on conditions of cultural plants in agrocoenosis in places transgenetic organisms introduction.

In order to improve control functions of inspection services in addition to procedures and rules of «Regulations on Biosafety Regime» it is necessary to prepare and ratify the norms determining powers, rights on sanctions and acceptance of measures to offenders, other rights and the responsibility of control services. These norms should be included in Statutes of these services. In addition it is necessary to provide:

Development of manuals on the mechanism of registration and liability of infringers, assessment of damages and payment of indemnifications for the damage put by accidents and illegal actions;

to prepare programs on coordination and rules on joint inspections;

τo create a network of identification laboratories with relevant equipment and qualified personnel.

τo create training programs for inspectors on bases of monitoring and the control over the transgenetic organisms turnover;

τo define format of the documentation on results of examinations, reports on monitoring and control acts and sanctions to infringers.

2.6. Information System and public participation in decision-making

Informing of the public on decision-making procedures, on results of experts’ risks assessment and planned commercial use of living modified organisms according to draft law «On Biological Safety» is established in the country by means of different channels, including:

32


• Information on commencement of research works, creation, testing in the closed systems and

planned release to the market of living modified organisms through representation of Copies of the Application on the location of the laboratory base, directed to local authorities (Articles 9 and 28);

• On field trials, including imported living modified organisms through submission to local authorities on the location of the planned field trials Copies of Applications on planned field tests (clauses{articles} 9, 11, 28);

• On use of living modified organisms and derivative products, including imported, in the closed systems (at the enterprises of the food-processing industry and shops of processing) through submission to local authorities on the location of the enterprise of Copies of the Application of the Manufacturer on the use of LMO’s/GMO’s (Articles 9, 28);

• On decision-making on results of expert risk assessment and entering into the Register, that automatically defines release of transgenetic organisms in domestic market, informed through mass media - SCAB at expenses of the User or the Applicant (Article 10, 28);

• On use for the purpose of introduction, included into the State Register of zoned and admitted crops and hybrids, including imported, and also other living modified organisms, by means of submission to local authorities Copies of the Application from producers of LMO’s/GMO’s (Articles 9, 28);

• On transboundary movement, internal transportation, living modified organisms turnover and their derivatives - by means of established international labelles (Article 27);

• On operations with regard to transgenetic organisms turnover used in the country - through the computerized information system on sites of databases of the public national BCH Mechanism (Article 8);

• On security measures in case of biologically-social accident - through mass media and Internet of ICAC (point 26.8 of of the Article 26).

Local authorities inform local residents about planned in the zone of their residing on use of living modified organisms with the indication of ICAC address to send possible remarks, proved objections or other comments. Gathering and processing of written comments of the population generalized by the independent BCH Mechanism in the sphere of biodiversity and biosafety and remarks of the public on published in Internet materials on transgenetic organisms turnover, regulation of the regime on utilization and accepted by SAAB measures is carried out by ICAC which is also provides procedure for public participation on accepted decisions with regard to transgenetic organisms turnover (point 28.3 of the Article 28).

In order to assist to the national expert structure which is carrying out the analysis of risks assessment from transgenetic organisms on biodiversity stability and human health, SCAB creates computerized databases on the international transgenetic organisms turnover taking into account, developed by the Expert Group on the biotechnology, established within the framework of Advisory Committee of the Organization on economic cooperation and development, an alphanumeric code of the individual identification code for transgenetic organisms. Into database on transgenetic organisms included information from all international sources, Codex Alimentarius, UNIDO (INCSB), UNEP-ITGB, UNEP-IMRO, “Biotrack” (OECD), UPOV, ICPP, IME and the most important, BCH Mechanism of Cartagena Protocol on Biosafety. These databases collected on sites of the Specially Authorized Administrative Bodies (SAAB) and are the major source of information during experts’ risk assessment and regulatory mechanisms development on LMO’s/GMO’s turnover (Article 8).

In order to create operative information processing and effective public awareness system it is necessary to create an independent public structure, free from pressure from governmental authorities as well as users concerned, including owners of processing enterprises using cheap imported raw

33


materials – derivatives from transgenetic organisms. As a basis for creation of the national independent information system NGO’s could play an important role, which field of activity is the area of international cooperation within the framework of the Convention on Biodiversity and Aurhuss Convention. Created public BCH Mechanism with assistance of the international funds and NGO’s support programs could develop training programs for expert structures, control and inspection services, users and governmental structures, and regulation of LMO’s/GMO’s turnover in the country. It is especially important for the Kyrgyz Republic located in the zone of possible penetration in the near future of diversified transgenetic organisms from neighbouring countries.

2.7. Obligations of the Kyrgyz Republic and formation of the reporting mechanism

Article 32 of the draft law «On Biological Safety» the responsibility with regard to reporting, including performance of obligations of the Kyrgyz Republic resulting from Cartagena Protocol on Secretariat informing of and BCH Mechanism on biosafety conditions of the country and regulation of transgenetic organisms turnover, is assigned on ICAC. More over ICAC, will periodically submit reports through Subsidiary Bodies of Cartagena Protocol on Biosafety for Conference of Parties on the measures accepted in the country in sphere of biosafety.

Table 2.2 Legal and procedural requirements and obligations

№ Obligations Articles of

Cartagena Protocol

Initial information report 1 Submit to BCN Mechanism the following information:

- available legislation relevant to the shpere of biosafety as well as guidelines, including of those LMO’s aimed for food, feed and processing;

- bilateral, regional and multilateral agreements and contracts

20(3)(a)-(b) 11(5), 14(2)

2 Inform the BCH Mechanism on those cases when the commencement of import deal has to begin at the moment of sending notification on movement

13(1)(a)

3 Inform BCH Mechanism on LMO’s importation exempted from PIC procedure

13(1)(b)

4 Inform BCH Mechanism in cases of national norms application with regard to concrete types of importation

14(4)

5 Submit to BCH Mechanism the contact details to receive information from other countries in cases of incidental transboundary movement in accordance with Article 17 of Cartagena Protocol

17(2)

6 Notify the Secretariat in cases of access absence to the BCH Mechanism and present written copies of decisions sent to BCH.

(for example 11(1))

Subsequent Information Report 7 Submit to BCH Mechanism the following information:

- conclusions of risks assessment and LMO’s ecological surveys, prepared in the frmework of ongoing regulation conducted in accordance with Article 15 of Cartagena Protocol;

- final decisions with regard to LMO’s import or release to

20(3)(с) – (e)

34


the environment;

- reports in accordance with Article 33 of Cartagena Protocol

8 Submit to BCH information on cases ofillegal transboundary movement

25(3)

9 Monitor the implementation of obligations under the Protocol and submit periodically to the Secretariat of reports within agreed time frame

33

10 Notify the BCH on any changes and information 20 11 Inform BCH on decision sent to Applicant with regard to

importation terms and conditions 10(3)

12 Information on final decision is taken with regard to created in the country and admitted for domestic use of LMO’s, that could be the subject for transboundary movement for direct use as food, feed or processing, including their commercial use, has to be communicated to BCH within 15 days from the moment of acceptance of a particular decision, including information contained in Annex VI

11(1)

13 Except cases of field trials, submit written copies of the final decision to the National Coordination Centre of Parties, who are previously inform Secretariat on access absence to BCH Mechanism on release to the market of LMO’

11(1)

14 Present additional information, contained in point (b) Annex VI, with regard to accepted decision to any Party, which is apply with such a request on LMO’s turnover.

11(3)

Periodical Reports 15 Each party carries out control over the implementation of its

obligations in the framework of the present Protocol and with periodicity defined by Conference of Parties, and making reports to Conference of Parties on measures taken for the implementation of the Protocol

33

35

Chapter 3. Procedural requirements for regulatory mechanisms in national system on biosafety

Chapter 3. PROCEDURAL REQUIREMENTS FOR REGULATORY MECHANISMS IN NATIONAL SYSTEM ON BIOSAFETY

3.1. Procedure of Applications processing а) Application (format and requirements) According to the point 9.3 of the Article 9 of the draft law «On Biological Safety» in Regulations on Biosafety Regime it is necessary to define all kinds of activity requiring the application (the scheme 4) for the acquisition of the right to be engaged in activity in the sphere of LMO’s/GMO’s turnover, and SAAB that regulate relevant types of activity, including: 1. Application on acquisition of the right

on genetic -engineering activity on research, creation and testing of LMO’s/GMO’s in the closed systems,

has to be send to the State Agency of Science and Intellectual Property where Decisions will be taken on the basis of risks assessment.

2. Application on importation for research purposes and creation in local conditions of LMO’s/GMO’s

has to be send to the State Agency of Science and Intellectual Property where Decisions will be taken on the basis of risks assessment.

The given kind of LMO’s/GMO’s use concerns the sphere of genetic-engineering regulation activity which in modern conditions of science development, in cases of uncontrolled manipulation with the genetic structure, represents serious threat for the country, especially in the part related to the use and creation of organisms pertained to 3-rd and 4-th risk level. Cartagena Protocol on biosafety does not provide mechanisms of regulation of this activity as its basically relates to safe transboundary movement of LMO’s/GMO’s, in this connection the obligatory format of the Application on the right to conduct genetic-engineering activity is absent. At the same time necessity of state control establishment over the organisms genetic modifications in the country, especially viruses and bacteria, requires introduction of specific norms on this activity and maintenance of the control in accordance with legislation and “Regulations on Biosafety regime”. Special biosafety regime on activities related to manipulations with organisms of 3rd and 4th risk levels is provided with establishment of licensing regime (Article 5 of the draft law) and special regime on tests making through creation at scientific divisions of the Commissions on biosafety (Article 17). Security control over the researches and uses of these organisms is provided by the special registration of these R&D works (with organisms of 3rd and 4th risk level) in the State Agency of Science and Intellectual Property (Article 8), and their use in the closed systems (for example, for the production of vaccines) - in SAAB according with production field (point 17.2 of Article 17 of the draft law). Due to the absence in the country of R&D works in the field of genetic engineering and own genetic components, suitable for modifications all potential Users at the initial stage will be compelled to use imported patented genetic components, including promoters, terminative, signal, vector components or ready genetic constructions. All these genetic components in a separation from genome of parental organisms are safe and represent genetic resources usually protected by patents, and are accompanied therefore by contractual obligations of access to bioengineering technologies (point 13.2 of the Article 13 of draft law). During the modification process by means of introduction of these genetic fragments (genetic constructions) new organisms, including microorganisms, with various risk level can be formed depending on properties of the recipient. In this connection, draft law limits access to manipulations with the genetic constructions in Articles 14 and 15, and in the Application for access to genetic engineering activity, except for the above-stated requirements, points 4.4 and 9.4 of the draft law should be taken into account.

The scheme 4

36


The scheme on applications processing and decision making on LMO’s/GMO’s turnover on the territory of the Kyrgyz Republic

1-71-7

56

1-7

PIC

456

1-7

Specially

Authorized Administrative

Bodies

Tests

Expert Commission

Expert Group

Experts’risks assessment

report ex

p

LMO

Reg

iste

r

Control risks analysis

456

PIC

(6)

PIC

(6)

1-71-7

1-7 Decision

Informing the

BCH Mechanism of CPB

ICAC

(Commission) 1-7

Registration of applications

And permissions

Application

comments

report

DecisionConfirmation

Publ

ic A

war

enes

s

Mass media

Gen

eral

Pub

lic

Applicant User

Producer Importer

Copy of Application

Local Authority

Report

Application on activity: 1. Creation and testing of LMO’s 2. Import for research, creation and testing of

LMO’s 3. LMO’s use in closed systems 4. Import for use of LMO’s in closed systems 5. Use for LMO’s introduction 6. Import for LMO’s introduction (PIC) 7. Import of LMO-PFE

1-7

e x p e r t s

3. Application on access to use LMO’s/GMO’s for field trials and introduciton including imported

has to be submitted for consideration and preparation of the Decision on: •

•

•

•

Created in the country of LMO’s/GMO’s - to the Ministry on Agriculture, Water

Resources and Processing Industry Imported GMO’s/GMO’s, with observance of prior informed consent procedure (PIC), through Interdepartmental Coordination-Advisory Council (Commission)

- to the Ministry on Agriculture, Water Resources and Processing Industry

The format of the Application is recommended by Cartagena Protocol on Biosafety and requirements to the information submitted in the Application on access to use LMO’s/GMO’s for introduction purposes, comply with Annex V of the NBF. 4. Application on access to

use LMO’s/GMO’s in the closed systems of industrial biosynthesis or import of derivative products for direct use as the food, feed or for processing

has to be send for consideration and preparation of the Decision on:

LMO’s/GMO’s, used in the food-processing industry

- to the Ministry on Agriculture, Water Resources and Processing Industry LMO’s/GMO’s, used for bioengineering synthesis of pharmaceutical preparations

- to Ministry of Health Care Format of the Application is recommended Cartagena Protocol and comply with requirements

of the Annex VI of the NBF.

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5. The copy of Application on access to all

kinds of activity on use of LMO’s/GMO’s, including imported

has to be send to local administration in order to observe public awareness requirements with indication of ICAC address to send comments.

Conformity of the format of Applications to the requirements determined by Cartagena Protocol, is established for applications for transgenetic organisms use in the closed systems and for the introduction purposes of both created inside the country, and imported, and also for imported LMO’s/GMO’s, intended for use as the food, feed and processing (that is on positions 3 and 4). Only those Applications that meets the requirements are accepted for experts’ risk assessment procedure, and on the rests - additional information by means of Confirmation is requested from the Applicant. b) Confirmation (format, requirements and terms to fulfil the duties) Confirmation has to be send from ICAC to the applicant on the received Application within the time frame determined by Cartagena Protocol (Article 9), - no more than 90 days from the date of reception of the Application, in conformity with that in Regulations on Biosafety Regime has to be defined maximal terms of the intermediate stages of Applications consideration, including experts’ risks assessment, preparations of Reports (acts of examination) and preparations of SAAB Decisions. Confirmation has to be send in writing according to format of the point 10.2 of Article 10 of draft law. In case of necessity to conduct the tests that requires long term monitoring, in the Confirmation final term for Decision preparation, which should not exceed 270 days from the date of reception of the Application is provided for. In exclusive cases this time frame can be extended, which will be specified in Confirmation, and this right shall be fixed in Regulations on Biosafety Regime. с) Experts’ risk assessment (procedure of formation of expert groups and risks assessment,

requirements, methods and format for risks assessment and the Report) Specially Authorized Bodies form expert groups for carrying out of experts’ risk assessment by attraction of experts from relevant bodies, taking into account Registers of Experts, on the condition of a payment stipulated by Regulations on Biosafety Regime. First of all risks assessment is conducted on the basis of Reports attached to the Annex to the Application (acts of examination) on transgenetic organisms risks assessment admitted or recommended to release on the market or inclusion to the LMO’s/GMO’s Register. In a mean time, expert decisions of foreign competent bodies are taken into account as well equally with domestic ones. Only in exclusive cases the proved doubts are resolved by carrying out of target tests, and this case will be designated in Confirmation to the applicant. Risks assessment through tests is carried out according to «Methodical manual for tests and experts’ risks assessment» which is on the stage of preparation with participation of all experts of the country and taking into account principles of international organizations and requirements of WTO (the Annex IV of the NBF). Imported transgenetic organisms for introduction purposes, especially in cases of the first importation, subject to experts’ risk assessment through field trials. The Complex Commission of Experts carries out researches, including specific medical, during a season of vegetation, and the Report on results of examination should reflect risks assessment not only LMO’s/GMO’s in general, but also safety of derivative product planned to use. The instruction on field trials will be communicated to the applicant by Confirmation, and subsequent organization and payment will be made at the expenses of the User. On results of experts’ assessments Expert Groups and Competent Commissions of Experts prepare the Act or the expert decision in the form of Report used as the basis for the Decision and entering of transgenetic organism into the Register of LMO’s/GMO’s, admitted for usage in the country.

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d) Decision (procedure, requirements and terms of preparation) Decision of the Specially Authorized Administrative Body (SAAB) is prepared on the results of consideration of conformity to requirements of Application’s format, the analysis of information and on the basis of the Report on experts’ risk assessment. Terms of preparation of the Decision should be determined by Regulations on Biosafety Regime with observance of time frames necessary to conduct experts risks assessment, as well as provisions provided for in point 12.4 of the Article 12 of the draft law. In this case only for LMO’s/GMO’s that requires field trials and tests, term of preparation of the Decision can exceed 90 days. Decision prepared on results of experts’ analysis on safe use of LMO’s/GMO’s, should contain, upon necessity, recommendations on measures and restrictions accompanying the use of transgenetic organism, and the terms and conditions for risks regulation resulted from application of derivative products (taking into account provisions of Articles 10-12, 17-21, 26). SAAB will communicate Decision to ICAC within time frame determined by Regulations on Biosafety Regime, for preparation of the Confirmation on positions 1-4, or decision-making on positions 1, 2, 4, and 3 - only in case of inquiry with regard to the right to conduct field trials. According to the prior informed consent procedure connected with transboundary movement of LMO’s/GMO’s for introduction, SAAB in case of the first planned movement of transgenetic organism considers only the right on introduction only within the framework of the admission to conduct field trials on the territory of the country. Decision on importation for introduction purpose can be accepted only in exclusive cases provided for in the Articles 20 and 26 of the draft law. e) Requirements on additional information submission (procedure) In case of failure to comply with established format of the Application (Annex V and VI) or in case of insufficient information necessary to conduct experts’ risk assessment, SAAB communicate to the applicant through ICAC the Confirmation in the form of request to submit additional information (points 9.6, 9.7, 10.2, 23.2 of the draft law). Time frame necessary to submit additional information, is not taken into account at definition of the term on decision making. The right on the proved prolongation of term for decision-making should be determined in Regulations on Biosafety regime. After decision-making ICAC could request additional information in case of change of conditions on use and in case of biologically-social emergency situation (accident) (points 26.2 and 26.6 of the draft law). f) Procedure on decision-making Decisions with regard to all kinds of activities would be taken within time frame not exceeding 270 days from the date of the Application submission to ICAC (Article 9) in the form of the Permission to the admission and activity or the Prohibition on LMO’s/GMO’s turnover in the country on the basis of the SAAB Decision, taking into account remarks and comments from the general public and, first of all, the population living in places of planned use of LMO’s/GMO’s. In order to inform the general public Interdepartmental Coordination-Advisory Council (Commission) on the basis of the materials from Decision communicate information through mass-media or Internet on the planned decision to grant Permission on a particular type of activities with indication of the area for use of LMO’s/GMO’s. Taking into account the fact that local population is informed through local administrations where the Copy the Application has been communicated from the applicant, time frame allocated on gathering of comments from public sector before Permission granting, should not be less than 60 days (2 months) from the date of sending the Copy of the Application to local administration.

39


Regulation on biosafety regime should provide for special dispute settlement procedures and mechanisms for the observance of all stakeholders’ interests, reflected in the international agreements of the Kyrgyz Republic, commercial activity of businessmen and public opinion which should be taken into account at decision-making. One of the assistance mechanisms is the public awareness rising on perspectives of bioengineering development and the real risks of results of this activity in specific conditions of social development of the various countries, presence of biodiversity and an intensification of productions. In this respect the Public National BCH Mechanism can play an important role. Permission on activities related to the use and turnover of LMO’s/GMO’s in the country could contain a number of restrictions or the special conditions on utilization stipulated by the provisions of the draft law and presented in the Instructions which is obligatory for the User. On the accepted decision and granted Permission ICAC informs through incorporated information network of the National BCH Mechanism, all national control services of the SAAB and Secretariat of the Cartagena Protocol on Biosafety. g) Change (revision) of decisions (procedure) Upon decision granting, depending on circumstances (points 24.1, 26.1 of the draft law) ICAC is entitled to change the Decision, and reconsider conditions on use or measures on risks regulation, stipulated by the Instructions. The user should be notified on change of a format of the Permission in writing within 30 days with indication of all changes with explanations. The user is entitled to appeal the changes or communicate to ICAC direct request to change the Decision in connection with new circumstances (point 24.2 of the draft law). On revision of the decision, within 30 days information will be communicated to the BCH Mechanism of Cartagena Protocol on Biosafety with a statement of the reasons underlying this change. The given procedures on changes of the Decisions granted should be stipulated in Regulations on Biosafety Regime.

Table 3.1 h) Resume with regard to rights and obligations of parties to Cartagena Protocol on Biosafety on

Applications processing in accordance with procedure on prior informed consent Steps Responsible

legal entity Key elements

Application with regard to planned transboundary movement (Article 8 of Cartagena Protocol on Biosafety)(PIC procedure)

Party of export, Exporter

Notifies in advance the National Competent Authority of the country of import prior the first transboundary movement of LMO’s for introduction into environment; submits as the minimum, information indicated in Annex V of the NBF; guarantee of legal requirements with regard to accuracy and reliability of the information

Confirmation of the Application receipt

Party of import, Interdepartmental Coordination-Advisory Council on Biosafety (Commission)

Confirmation of the receipt (within 90 days) Designate the date of receipt; Confirm that application contain all necessary information; Indicate the procedure on decision making that is going to be applied 9Articles 20.2, 23.3 of the draft law)

Procedures on decision-making (Articles 9,10,15, 26 of Cartagena Protocol on Biosafety)

Party of import and country of the planned introduction

Inform the application in writing (within 90 days after the receipt of Application) that permission for transboundary movement could be granted upon consent from country of import; decision will be taken o the basis of risks assessment conducted during field trials in accordance with Annex IV and Methodical Annual on Tests and Risks Assessment; Party of import is entitled to request from the exporter and Applicant to conduct risks assessment (Article 15(2)) and take all the expenses linked with risks assessment procedures (Article 15(3) of the

40


Protocol); Consider confidential information provided for in Article 21 of the Protocol; Party of import is entitled to take into consideration certain social and economical aspects arising with regard to LMO’s impact on biological diversity, in accordance with international obligations (Article 26(1) of the Protocol); In accordance with its domestic legislation, to conduct consultation procedure with public sector for decision making (Article 23(2) of the Protocol )

Decision making Article 10 of Cartagena Protocol

Country of import and country of the planned introduction

Within 270 days from the date of the Application receipt to take a decision on importation approval subject to certain conditions or without any of them; refuse the importation; request additional information; to inform the applicant, with regard to time frames on decision making. In accordance with national legislation to inform public sector o decision taken (Article 23(2) of the Protocol); to present the reasons for import refusal, except of those cases when importation is not subject to any formality. To inform the BCH Mechanism under the Cartagena Protocol

Reconsideration of the decisions (Article 12 of the Cartagena Protocol)

Country of import (on its own initiative or upon request from the party of export or applicant) after decision taken

Country of import is entitled to reconsider decision taken and enter changes into decision taken in the light of new scientific information. In this case the party shall: Inform the applicant and BCH Mechanism within 30 days; Designate the reasons on change of the decision. Party of export or applicant is entitled to request country of import to reconsider decision on the basis (i) changes in circumstances and (ii) availability of additional scientific or technical information, e.g. to appeal the decision (Article 12 of the Protocol)

Table 3.2

i) Resume on rights and obligations of Parties in accordance with Article 11 of the Cartagena Protocol with regard to procedures on Applications processing on LMO’s, used as food, feed or for processing

Steps Responsible legal entity

Key elements

To inform BCH Mechanism with regard to decisions on domestic use (not for field trials) of LMO’s used as food, feed or for processing subject to transboundary movement

Party that takes final domestic decision in the country of creation of LMO’s as food, feed or for processing (LMO/GMO-PFE) on release to the market

Informs BCH Mechanism within 15 days. Presents as a minimum, information contained in Annex VI of the NBF guarantees legal requirements with regard to accuracy and reliability of the information presented (Article 11(2) of the Protocol Submission upon request, in case of necessity, of any additional information to any of parties (Article 11(3) of the Protocol)

Inform BCH with regard to national legislation, regulations and principles

All parties to Protocol Party which is being developing country or country in transition without national regulatory regime on biosafety

Communicate to BCH the copy of the national legislation, legal and normative acts that relates to LMO’s importation (Article 11(6) of the Protocol)

Procedures on decision making with regard to

Party of import Party which is being

National regulatory regime developed in accordance with goals of Protocol

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LMO’s importation developing country or country in transition without national regulatory regime on biosafety

Risks assessment conducted according to Annex IV of the NBF and Methodical manual on tests and risks assessment

3.2. The register admitted for use in the country transgenetic organisms Created in the country transgenetic organisms as well as imported, could be released in domestic market for commercial use through entering into the Register of LMO’s/GMO’s, maintained by the State Agency of Science and Intellectual Property. The basis to enter transgenetic organism into the Register is the Permission of the ICAC on use of transgenetic organism or special decision. Decision taken by SAAB on approval to use LMO’s/GMO’s with recommendations on its introduction into production, accepted on the basis of the Reports (Acts of examination), prepared by experts of the country on the basis of the analysis: - Previous or existing reports, including the countries of export on researches, tests and risks assessment on the basis of which transgenetic organism was admitted for use; - Report on risks assessment on results of tests created in the country and admitted for use transgenetic organisms;

- Report of the Complex Expert Commission on results of field trials conducted in accordance with PIC procedure or created in the country LMO’s/GMO’s.

In the Register risk levels for each transgenetic organism are registered, established by experts (according to Article 4 of the draft law), restrictions on use, special conditions and measures on risks regulation, determined by Expert Groups or Complex Expert Commission. Inclusion into the Register should be accompanied by the procedures guaranteeing observance of patent rights and other intellectual property rights, as well as provide conditions of mutual arrangements on access to technologies and benefit sharing on a fair and equal basis of results on use of genetic resources. The order and procedures of these legal guarantees reflected in the Register, should be determined in Regulations on Biosafety Regime. More over, in the Regulations procedure on patents granting should be reflected and copies of the information (point 13.1 of the draft law), except confidential, to users of transgenetic organisms admitted for turnover in the country. Also, in the Regulations according to point 4.2 of the draft law it is necessary to define typical measures on risks regulation, the order and conditions of reference of transgenetic organisms to the certain risk level and the order for change risk level on the basis of expert analyses results. The list of the world well known transgenetic organisms turnover with indication of their risk level and an individual identification code will be published on sites of ICAC as the Annex to the Methodical Manual on Tests and Risks Assessment and reconsidered according to receipt of the new scientific data on transgenetic organisms. Field trials of plant varieties, carried out by the State Commission on Plants Testing, with the purpose of their commercial production in the Kyrgyz Republic, including imported, are carried out upon Permissions with observance of breeders rights. Plant varieties that comply with conditions on agronomical and technological value, on results of these trials are entered into the State Register of the Kyrgyz Republic, zoned and admitted for use crops and hybrids with observance of all breeders’ rights established by the international agreements. In the regulations procedures should be reflected and the order of inclusion into the Register of varieties and hybrids as well as legal norms on the protection of breeders rights(points 13.4 and 13.5 of the draft law). 3.3. Tests (format, procedures and rules) In genetic-engineering activity, tests are included into the common complex of researches and procedures on transgenetic organisms’ creation. Thus they include a number of tests for stability of genetic constructions during a cellular metabolism (pleiotpropy, epistazy and effect of the position), steady transfer of the got attribute at cellular division and a metabolism in tissue vegetative cultures or

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at growth transgenetic animal (fishes and so forth), estimation of the pleotropic effect and its stability at multiplication and creation of transgenetic organisms reproductive populations and safety of derivative products, including collateral enzymes and other peptide connections. All these tests are conducted in the closed systems and enter into a complex of genetic-engineering activity regulated by the granted Permission on bioengineering activity. Defective and removed models during researches are subject to recycling or destruction in accordance with Regulations on Biosafety Regime (point 11.2 and Article 5 of the draft law). Selected on safety and suitability for introduction into production and multiplied transgenetic organisms pass final tests and risks assessment at prospective kind of use with participation of specially created Expert Commission, attracted for examination according to Registers of Experts of all SAAB (point 11.5, taking into account requirements of Article 12 of the draft law), using in their work «Methodical manual for tests and experts’ risk assessment» (point 4.3 of the draft law). The structure and specialization of the involved experts, procedures of attraction, the form of payment and format of the Report (Act of examination), prepared on results of tests and transgenetic organism’s safety assessment, are defined by Regulations on Biosafety Regime. Imported transgenetic organisms for use in the closed systems, including LMO’s/GMO’s, intended for researches and creation of new clones, use in pharmaceutical industry and for veterinary, and also derivative product directly intended for use as the food, feed or for processing at the local enterprises, if necessary are tested. ICAC is entitled to put forward proved (on results of examination of materials of the Annex to the Application) requirement on preliminary tests of planned for importation transgenetic organisms, and to suggest the User to request control samples for these purposes (point 18.3 of the draft law). Conditions and order for the suspension of import, with necessity to conduct tests, are defined by Regulations on Biosafety Regime taking into account established risk level (point 16.2). Imported for the first time transgenetic organisms for the purpose of introduction pass through the procedure of field trials in accordance with Articles 11, 19, 20, 26 of the draft law. The order to conduct field trials, structure and experts’ qualification, conditions for experts’ assessment of transgenetic organisms safety are defined by the Regulations on Biosafety Regime taking into account «Methodical manual for tests and risks assessment» on the basis of normative provisions of the draft law. Special attention has to be paid to the norms with regard to security conditions for the personnel and neighboring sites of agrocoenosis and natural ecosystems taking into account that field trials could be conducted for microorganisms, plants and animals. 3.4. Monitoring and the control (procedures and rules) Monitoring of biosafety conditions during the use of transgenetic organisms is composed from the informative data accrued on the site of the Database, admitted for use LMO’s/GMO’s, including: - Report of the User (Producer) introduced transgenetic organisms, including production of commercial products intended for sale. The report is submitted to SAAB according to profile of production on results of the first year of introduction into commercial production; - Annual reports of SAAB control services on inspections of biosafety conditions in places of

transgenetic organisms commercial use, including closed systems and introduction; - Reports of the complex (joint) inspections in accordance with Schedule, authorized by the

Coordination plan of joint actions of control services of all SAAB. The order for reports submission and systematization of these materials individually for each kind (clone) of transgenetic organism, access to information for the public, submission of reports to the Secretariat of Cartagena Protocol on all admitted for use transgenetic organisms is defined by the Regulations Biosafety Regime.

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3.5. Export and transit of transgenetic organisms The order for transgenetic organisms export is defined by point 18.4, 23.5 of the draft law. In the regulations on biosafety regime the rules with regard to transboundary movement has to be provided for, for all created in the country transgenetic organisms and planned for export, which are mainly based on the requirements of observance of all rules and the order for transboundary movement, established in the country of export. In Regulations legal requirements has to be provided for as for accuracy of the information submitted by domestic exporters through the Application to the country of import. Transit through the territory of the Kyrgyz Republic of transgenetic organisms can only be possible after submission of relevant Application on transit from the country of import or export (point 21.2), with observance of all procedures of biosafety maintenance (packaging, labeling and rules of cargoes handling) as well as international norms on transboundary movement of cargoes. 3.6. Illegal transboundary movement and emergency situation Incidental (illegal) transboundary movement is controlled by customs service, and a cargo illegally imported on customs territory, is subject to removal or destruction at the expenses of the exporter or the User in accordance with international norms (Article 25 of the draft law). In case of penetration of transgenetic organisms to the territory of the Kyrgyz Republic the situation is defined as emergency, just as at any accidents resulted from transgenetic organisms release during their use in closed systems. The order of measures is defined by points 26.6-26.9, and liability of persons in such circumstances is provided for in Article 30 of the draft law and relevant laws of the Kyrgyz Republic. Regulations on Biosafety Regime should provide procedural rules for official registration of documents, including acts of estimated damages and the order of processing. 3.7. Confidential information and the order of its protection In regulations on Biosafety regime it is necessary to define the order for consultations with Applicant and disagreements settlement procedures concerning the status of confidential information. Protection of the confidential information is defined by the legislation in the field of intellectual property rights. 3.8. Comments gathering and their processing Time frame for comments submission from the general public on all matters related to LMO’s/GMO’s turnover is two months from the date of making available to the public through mass-media or an electronic media. All comments have recommendatory character and can be taken into account at decision-making only in case of scientifically proved and demonstrative character. In case of conflicted situations essential remarks are transferred to control expert risk assessment and information on that is communicated to the BCH Mechanism for assistance to solve the matter with participation of the exporter or transgenetic organism’s creator with relevant procedure on prolongation of the term for Application processing. In procedures related to public awareness in ecological issues, assistance to ICAC and SAAB in the process of qualitative information space creation on biosafety, training programs development for the improvement of professional skill of the staff from state bodies and expert structure, the public BCH Mechanism on biodiversity and biosafety created on NGO’s, dealing with ecological matters, environmental protection and information provision to the public in framework of Aurhuss Convention, could play an important role.

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3.9. Country reports on obligations and implemented arrangements Reports and responsibility on its performance according to the requirements of Cartagena Protocol on Biosafety is assigned (Article 32 of the draft law) on ICAC and as a whole according to the format comply with requirements stated in Table 2.2 and the Annex III of the NBF. Upon agreed terms and conditions with Secretariat of Cartagena Protocol this work can be assigned to the national public BCH Mechanism on biodiversity and biosafety.

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Chapter 4. Needs for capacity building creation for the purposes of Cartagena protocol implementation Chapter 4. NEEDS FOR CAPACITY BUILDING CREATION FOR THE PURPOSES OF

CARTAGENA PROTOCOL IMPLEMENTATION Transition of Kyrgyzstan to market economy appeared very complex and difficult. Production volumes reduction and increased level of poverty connected to it appeared larger and longer in time than it was expected. Stagnancy of these processes in terms of general deficiency of natural resources have resulted in a low competitiveness of the national economy, increase of pollution level and destructive operation of natural resources. Thus, at general expectation of changes to the best, new problems have appeared, and insufficient readiness to solve them has lead to braking of all reforms process. In recent years positive shift aside search of new opportunities to solve poverty matters, through sustainable development processes with stress on development of own potential was indicated. Kyrgyzstan has actively joined to international processes, including, participation in work of international conventions, has taken up obligations to observe provisions and requirements of those or other international agreements. For giving to these positive tendencies complex, sustainable and “self-development” character it was required to strengthen the quality of reforms on the basis of modern principles of international cooperation by active involvement of all society and intersectoral interaction improvement during implementation of programs on sustainable development and poverty alleviation. For this purpose the new approaches accelerating dynamical development of the country and raising management efficiency, including development and programs implementation in sphere of management and decentralization, economic development, preservation of the environment and development of human and social potential have been applied. Illustration of deepening democratization processes is the participation of a civil society in political and social life and participation in discussions of various programs and economic projects. These approaches have found reflection in the long-term strategy «the Complex basis of development of the Kyrgyz Republic till 2010», in the intermediate term program «National strategy on poverty alleviation till 2005» and «the Agenda for 21 century». Turn aside towards the sustainable development – the matter of global policy which is assumes the establishment of democratic decision-making process, formation of the general responsibility and distribution of functions and fields of activity on environmental management between the various parties concerned. But the most important role has to be attached to mechanism on effective interaction and cooperation between the state control bodies and institutes of a civil society. As an example of intersectoral interaction can serve stages of preparation serve «Strategy on biodiversity preservation of the Kyrgyz Republic» (2002), «Programs of actions till 2010: the Agenda for 21st century of the Kyrgyz Republic» (2002), «National survey RIO+10 on achievements of the Kyrgyz Republic on sustainable development promotion» (2002). Countries of the Central Asian region in order to improve programs efficiency on sustainable development during the preparation for the World Summit on Sustainable Development have acted with initiative on subregional partnership for unified potential creation on sustainable development of the region through process of overall goals formation and strengthening of cooperation mechanism – Central Asian Initiative on Sustainable Development/ Central Asian Agenda for 21 Century».

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Chapter 4. Needs for capacity building creation for the purposes of Cartagena protocol implementation

47

Dynamic of indexes of basic social and economical indicators of food security (in % from living wage of the employed population)

100 100 100100100

62,865,359,4

50,851,5

39,4 39,646,1 48,8 48,5

20,3

38,144,5

41,4

25,421,5 24,4 24,4 23,7

8,4 8,87,15,7

0

20

40

60

80

100

120

1998 1999 2000 2001 2002

%

living wage average per capita

expenses on goods and services incomes from sells of agricultural products

expenses on nutrition expenses on services

Central

Asian

initiative (SAI) has been supported at the World summit on sustainable development(2002) and at EU Conference of ministers on environmental protection and was included into Johanesburg Plan on partnership initiatives, declaration of the 5th European Conference of the UN European Economical Commission, Ecological Strategy of the Eastern Europe, Caucasus and Central Asia. At present time within the framework of the World Summit on Sustainable Development and EU Declaration, Agreement on partnership is on the stage of development between the Central Asian countries and world community on collaboration for the purposes of sustainable development in the region. Along with it, one of the tasks on implementation of the Plan WSSD and ES EESSA in the «Agreement on partnership» is the inclusion of biosafety issue important for the whole region - as the basis for biological resources preservation. For effective implementation of Cartagena Protocol and creation of the reliable international system on biosafety, cooperation between countries and support from the world community to developing countries of essence in creation of their potential in the field of biosafety. Many of such countries now do not have neither technical and financial resources, nor qualified staff to fulfil in a most complete manner requirements of the Protocol. «Plan of actions on capacity building» (decision 2/9, UNEP/CBD/ICCP/2/15) pays special attention to financial, technical and scientific assistance to developing countries, including countries in transition, and also to the countries being the centers of origin for cultural plants and the centers of genetic diversity. Understanding of the fact that preservation of the worlds’ genetic diversity, e.g. biodiversity, in modern conditions of rapid development of bioengineering technologies is possible only under condition of the collective control establishment over this process and rendering of appropriate support to developing countries, in order to cover additional charges which they will bear during implementation of obligations, has been fixed in the Convention on Biological Diversity. Convention provides for (article 20) priorities for the Parties requiring assistance, including aspiration of developing countries to take steps towards poverty alleviation. (point 20.4) as well as with regard to mountain relief of a particular country (point 20.7). These kind priorities are provided for by Cartagena Protocol as well. Rendering of assistance to the Parties ifor the implementation of the Protocol takes into account special needs of developing countries which are the Centers of origin for cultural plants and the Centers of genetic diversity (point 20?). There are only few countries having all this package of priorities, and Kyrgyzstan is included into this number.


•

•

•

•

•

Intergovernmental Committee on Cartagena Protocol has defined the following key points that requires acceptance of necessary measures on capacity building creation within the biosafety system:

а) Institutional capacity building composed from: Legislative bases; Administrative bases; Τechnical, scientific and telecommunication infrastructure; Financing mechanism and Control Mechanisms, monitoring and risks assessment;

b) Development and human resources training; с) risks assessment and other scientific and technical skills; d) Risks regulation; e) Public awareness rising, participation and education at all levels, including state authorities, all

parties concerned and representatives of the general public; f) Information exchange and data management, including full participation in the BCH

Mechanism; g) Cooperation in scientific, technical and institutional areas at subregional, regional and

international levels; h) Transfer of technologies; i) Identification.

Efforts on capacity building includes assessment needs, definition of opportunities available at national level, creation and strengthening of national establishments, development of human resources’ skills and experiences, through education and training, creation of necessary scientific institutes and information centers, estimation of economic efficiency and security during transfer of technologies. These and other efforts on capacity building are usually carried out due to maintenance of the external technical assistance and financial resources on bilateral, multilateral or private basis. The success of initiatives on national capacity building creation can be provided only with broad participation, including governmental and administrative bodies, scientific, commercial and private sector and NGO’s. However, in the existing circumstances with regard to transboundary movement of transgenetic organisms in Central Asian region, formation of the national capacity building on biosafety in Kyrgyzstan will be accompanied by certain matters connected to the special international status of the country: Kyrgyzstan is the only country in the region - member of the World Trade Organization, and aspire to achieve in the near future compliance of the regime on transboundary movement of goods to the norms of international law fixed in GATT, SPS and TBT. Unfortunately, for the time being matters related to the parity of Cartagena Protocol provisions and WTO agreements remains uncertain. For example, «Precautionary Principle» (articles 10, 11); «labeling of transgenetic organisms LMO-PFE» since in the USA soybeans and other products imported by the countries for domestic processing are not labeled (information of the USA State Department dated 2.12.2002) . More over if we take into account the fact, that European Union in 2004 has cancelled under the protests of countries - suppliers the moratorium on import of transgenetic organisms it becomes clear, what difficulties will be experienced in the future by Kyrgyzstan. Even at well established legislative and administrative structure, without scientific and technical bases for identification and qualified expert structures, accepted decisions will have disputable character. Secretariat and BCH Mechanism have to finalize and coordinate certain matters with regard to decision-making provided for by the Protocol, with provisions of WTO agreements which will be analyzed, finally in the context of WTO rules (for example «the validity of prohibition based on Precautionary Principle»). It would be expedient, that the Protocol in this respect would get for WTO, the same status, as Codex Alimentarius and ICPP. It is especially important for Kyrgyzstan, as WTO member, in such circumstances of possible penetration to the country of goods that potentially contain transgenetic organisms, including: soya from Uzbekistan for processing by local enterprises, apple trees from China, apples from Iran and China as food. All these goods are not labeled, and for their identification Kyrgyzstan has no laboratory and scientific bases.

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Chapter 4. Needs for capacity building creation for the purposes of Cartagena protocol implementation Thus, Kyrgyzstan, being in special conditions of formation of the national capacity building on biosafety and actively participating in all international initiatives on environmental protection of the, biodiversity preservation, sustainable development and poverty alleviation, proceeding from the necessity of broad and effective international cooperation, has the opportunity to expect essential support of all steps on national biosafety system creation, especially, regarding creation and strengthening of national biosafety capacity building, implementation of the National Biosafety Framework (NBF) and obligations of the Kyrgyz Republic within Cartagena Protocol on Biosafety (CPB).

Promotion project and capacity building strengthening necessary for National Biosafety Framework implementation (NBF) and obligations of the Kyrgyz Republic on Cartagena

Protocol The Goal: To assist the Kyrgyz Republic in NBF implementation in accordance with «Program of

actions till 2010: Agenda for 21 century of the Kyrgyz Republic» and requirements of CPB. Task: to assist the Kyrgyz Republic to fulfill NBF implementation according to obligations of CPB

through capacity building creation. Special tasks: A. Assistance in formation of the national policy in the field of biosafety and definition of key

components in national Strategy on biosafety for appropriate representation of biosafety matters in national plans and programs o sustainable development and environmental preservation. А1. Organization of two meetings of all parties concerned and target groups with Governmental

and Parliament representatives for definition of target components of the Strategy on national biosafety system creation.

А2. Development of the Strategy and Plan of Actions of the Kyrgyz Republic on biosafety. А3. Development of proposals on presentation of biosafety matters taking into account interests

of the Kyrgyz Republic, within Central Asian Initiative on Sustainable Development (CAI), Economic strategy EECCA and in the Agreement on partnership (EEC the United Nations).

B. Assistance in regulatory regime establishment that comply with international requirements (WTO) and goals of Cartagena Protocol on biosafety.

B1. To assist in acceptance of legislative initiatives on regulatory mechanism establishment and development of the relevant amendments and additions into existing normative base, as well as development of accompanying norms and legal acts in order to fulfill national needs.

B2. Development of technical manuals for inspection services and administrative system. B3. Organization of training courses for the improvement of professional skills, for decision

makers and control authorities. C. Assistance in establishment of the national system of Applications processing and development of

national expert structures for scientifically validated risks assessment. C1. Creation of experts’ potential and preparation of methodical manuals on tests and risks

assessment taking into account international requirements and technologies.

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C2. Training of experts and creation of a technical basis for the Database creation on global experience of experts’ risks assessment and standard techniques for applications examination.

C3. Preparation of the project oт possible threats of GMO’s penetration and character of possible ecological impact.

D. Assistance in establishment of the national monitoring and control systems. D1. Creation of the laboratory base, including express-analysis, for detection and identification

at all stages of GMO’s turnover. D2. Preparation of technical manuals on monitoring and training of the staff on identification

methods. D3. Creation of technological base for the formation of GMO’s Register and initial bases of

information Registers and possible threats. D4. Training for the staff, involved in activity with GMO’s, including business sector and

farmers (processing industry). I. To assist in establishment and consolidation of national system on education, information, access of

the public to the information and participation in decision-making. I1. Creation of a feedback mechanism on participation of the public in decision-making and

supply of information on biosafety. I2. The organization of workshops for businessmen and farmers, especially, in zones of genetic

security. I3. Assistance to technical maintenance of communication space of the country and creation of

base for electronic communication with foreign structures in the field of biosafety and sustainable development.

I4. Rendering of assistance in creation of the national public BCH Mechanism on the basis of ecological NGO’s.

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Chapter 5. Information on the project implementation Chapter 5. INFORMATION ON THE PROJECT IMPLEMENTATION Collaborative Global Project UNEP/GEF «Development of the National Biosafety Frameworks» has started in June, 2001. Initiated by the world countries global project was developed to assist in development of national structures to deal with living modified organisms (LMO’s) and implement provisions of Cartagena Protocol on Biosafety. In the Kyrgyz Republic UNEP/GEF Project “Development of the National Biosafety Framework ” has started in 2003. Executive Agency: Ministry of Ecology and Emergencies of the Kyrgyz Republic. Address: 2/1, Toktonalieva str., Bishkek, Kyrgyz Republic. In the work on development of the biosafety framework experts representing ministries and agencies, scientific institutions, public organizations as well as business sector are involved.

National Project Coordinator: Azamat Hudaibergenov

National Coordination Committee: 1. Djanuzakov Kanat Chynybaevich, Chairmen, Deputy Minister of Ecology and Emergencies of the

Kyrgyz Republic.

2. Aitmurzaeva Dinara Turdakunovna, member, Head of the Department on procedures Development on approval and compliance of quality requirements of the National Institute on Standards and Metrology of the Kyrgyz Republic

3. Ahmetov Uran Tulondievich, member, Deputy Head of the Legal Department of the Ministry on Economical Development, Industry and Trade of the Kyrgyz Republic.

4. Burhanov Aitkul Mustafaevich, member, Chairman of the State Forestry Service of the Kyrgyz Republic.

5. Eletzkiy Anatoliy Ivanovich, member, PhD in Agricultural Sciences, leading specialist of the Division on plant cultivation of the Department on Agricultural Production of the Ministry on Agriculture, Water Resources and Processing Industry of the Kyrgyz Republic

6. Junushov Asankadyr Temirbekovich, member, professor, Director of the Institute of Biotechnology of the National Academy of Sciences

7. Kasymov Omor Tilegenovich, member, professor, Director of Scientific and Production Union “Prophylactic Medicine”. Ministry on Health Care of the Kyrgyz Republic

8. Moldogazieva Kaliya Sartbaevna, member, PhD in medical sciences, Director of the Center on Human Development “Tree of Life”.

9. Rudenko Vyacheslav Nikolaevich, member, Director General of the State Seed Inspectorate under the ministry of Agriculture, Water Resources and Processing Industry of the Kyrgyz Republic.

10. Sydygalieva Jyldyz Omurkulovna, member, third secretary, of the UN Department and International Security of the Ministry on Foreign Affairs of the Kyrgyz Republic.

11. Sultanalieva Elvira Turuspekovna, member, leading specialist of the legal department on coordination of legislative activity of the Ministry on Justice of the Kyrgyz Republic

12. Egemberdiev Djumadil Berdigulovich, member, Chairman of the Board of Directors of the Joint Stock Company «Shoro».

13. Hudaibergenov Azamat Djuzumkulovich, NCC Secretary, National Project Coordinator,

Address of the Project: 720055, 2/1, Toktonalieva str., Bishkek, Kyrgyz Republic, Room 111, tel.:(+996 312)610237, fax:(+996 312) 549264

Duration of the Project: 21 month. Commencement - October 2003, completion – June, 2005.

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Chapter 5. Information on the project implementation

Main Phases of the Project:

Stage 1. Study of the situation and preparation of the National Survey on Biosafety of the Kyrgyz Republic

On the first phase of the Project gathering of the information relevant to biosafety have been conducted as well as public awareness rising and decision makers on the notion of the matter. At that stage great importance have been paid to definition of beneficiaries and parties concerned. During the first stage of the project the following activities have been conducted:

• Defined beneficiaries and parties concerned;

• Contacts with representatives of parties concerned for collaborative interaction on the NBF preparation.

• Analysis and review of international and national legislation in this field have been conducted;

• Database of specialists and experts in relevant fields have been created

• A number of arrangement with target groups of the project have been conducted;

• Information on biosafety matters and the project were reflected in national mass media (national and local newspapers, magazines, TV and Radio Stations)

• Review of the international regulation of biosafety have been conducted

• Information labs, centers and other institutions relevant to biosafety matters were collected.

Great importance of the working group of the project were paid to the assessment of the existing potential of R&D and Production Organizations, level of scientific researches, availability of production developments and programs and etc. The outcome of the first stage of the project was compilation of the Registers of R&D organizations dealing with biotechnology, databases of specialists and experts, information on technologies and equipment used as well as national and international projects on R&D works in the field of biotechnology.

At that phase of the project broad range of experts and specialists were attracted to study of the real situation and works in the field of biotechnology and biosafety in science, environment, agriculture, health care, industry and education. Compex of measures were thourougly studied aimed at biodiversity preservation and sustainable development.

In the legislative review all aspects of international and national laws and norms capable for adaptation to deal with biotechnology and biosafety matters were considered.

Attention has been paid to international obligations of the Kyrgyz Republic on matters included into the focus of the project.

Data on programs in the field of biotechnology, laboratory basis, human resources were collected. Existing control mechanisms and acquisition of the information in this sphere were defined.

Special attention has been paid to public awareness rising issues on biotechnology matters. In the accountabe period a number of Artiles we re published in national news papers (Vechernyi Bishkek, Erkin-Too, Spasatel, Obshestvennyi Reyting, Argumanty i Facty , Kyrgyzstan, Dlia Vas, Slovo Kyrgyzstana, Bishkek Times), reports we re made on TV (KOORT, TRC Piramid, Independent Bishkek Television, Mir) and radio stations (MIR, Maximum, Eho Moskvy, Retro, Europe plus, Russkoe Radio, Kyrgyzstan Obondory).

Representatives of all parties concerned, including NGO’s and business sector were attracted for information gathering.

As result of the first stage of the project National Survey on Biosafety in the Kyrgyz Republic was prepared. Working version of the document was placed on the official web site of the project at (www.biosafety.kg) for consideration by stakeholders concerned. After the broad discussion on the

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Chapter 5. Information on the project implementation National workshop on biosafety, the report was published and distributed among decision makers as the document that highlights current state of biosafety in the country, potential of the republic and gaps that have to be covered for the creation of effective biosafety system in the Kyrgzy Republic.

Stage 2. Analysis and consultations. During that period of the project analytical, consultative and communication works have been conducted aimed at priority spheres definition and the parameters for the NBF development of the Kyrgyz Republic. In the analytical work representatives of all parties concerned were involved through participation in workshops, working meetings, individual consultations. At that stage of the work the outcomes of the surveys and researches were considered. On the basis of the information collected priorities in the field of biosafety for Kyrgyzstan were defined, taking into account features of the country. On revealed matters needs were defined and mechanisms to deal with these issues were developed.

During that phase of the project a number of workshops amd meetings were conducted. Workshops and meeting were conducted on a regular basis and aimed at definition of the most effective mechanisms to deal with biosafety matters taking into account opinions of all parties concerned.

As a result of consultations, workshops, working meetings and discussions, foundations for the National biosafety System development were defined as the complex and holistic program, that could allow to use modern biotechnology in a safe manner from biosafety point of view. Special attention has been paid to international obligations of the country and existing regional mechanisms of cooperation in the region.

Matters of legislative basis development, administrative system, decision making system and public participation in biosafety issues were considered.

Stage 3. Preparation of the National Biosafety Framework of the Kyrgyz Republic During the development of the National Biosafety Framework of Kyrgyz Republic a series of workshops, working meetings, individual consultations and thematical meetings were conducted with all organizations involved on separate components of NBF. Working version of document was prepared.

At that phase of the project the following representatives have been participated:

• The Secretariat of the Council on Security;

• Ministry of Ecology and Emergencies;

• Ministry of Finance;

• Ministry of Health Care;

• Ministry of Agriculture, Water Resources and processing Industry;

• State Forestry Service;

• Ministry on Economical Development, Industry and Trade;

• National Institute on Standards and Metrology;

• National Academy of Sciences;

• NGOs;

• Business Sector.

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Chapter 5. Information on the project implementation Publications: By the Working Group of the project developed, published and distributed among ministries and agencies of the republic a number of informative booklets, gazettes, poster sand calendars on the theme -biosafety

On thematical researches the following materials have been prepared:

− Informative and scientific articles, reflecting current state of biotechnology in the world and matters related to GMO’s;

− Electronic version of database on organization relevant to biotechnology, list of specialists;

− Database on “Botanical and Geographical Centers of Cultivated Plants and their Wild Relatives in the Kyrgyz Republic”

− Code of laws in the field of biodiversity, biosafety and genetic engineering in the Kyrgyz Republic. Workshops and working meetings on biosafety

№ Date Title 1. February 5-9,

2002 Regional meeting on capacity building creation in the field of biosafety in Eastern Europe and CIS countries (Nitra, Slovakia)

2. May 27-30, 2003

Subregional workshop on risks assessment and public participation (Vilnius, Lithuania)

3. December 4 2003

First NCC meeting (introduction of NCC members, presentation of the project, Information on Cartagena Protocol)

4. December 9-12 2003

Subregional workshop on risks assessment and public participation (Antalya, Turkey)

5. December 25, 2003

Presentation of the Project UNEP/GEF “Development of the National Biosafety Framework in the Kyrgyz Republic” Capacity building creation for the implementation of Cartagena Protocol on Biosafety in the Kyrgyz Republic

6. February 9-27, 2004

Seventh Conference of Parties of the Convention on Biological Diversity (Kuala-Lumpur, Malaysia)

7. April 21, 2004 Second NCC meeting 8. April 21, 2004 Workshop «GMO’s and their derivatives in biosafety system of the Kyrgyz

Republic» 9. May 18, 2004 Informative workshop “Biosafety matters and genetic engineering”

(Osh) 10. May 20, 2004 Workshop «Biosafety matters and genetic engineering»

(Jalal-Abad) 11. June 16

2004 Working meeting with parties concerned in Issyk-Kul province

12. June 25-26, 2004

Final national workshop on biosafety of the project UNEP/GEF “Development of the National Biosafety framework in Tadjikistan” (Dushanbe, Tadjikistan)

13. June 13, 2004

Third NCC meeting

14. July 26 - August 6

2004

International Advanced Training Course «Holistic foundations on risks assessment and regulation of genetic engineering and GMO’s» (Tromso, Norway)

15. August 7-September 2,

2004

International Advanced Training Course «Genetic resources and Intellectual Property.Pathways for development» (Lund, Sweden)

16. October 14, 2004

Meeting of lawyers of different ministries and agencies on development of the draft law on biosafety

17. October 18-20, 2004

Subregional on biosafety of the project UNEP/GEF “Development of the National Biosafety Framework in Tadjikistan” (Dushanbe, Tadjikistan)

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Chapter 5. Information on the project implementation 18. October 26,

2004 Extended NCC Forth Meeting (with participation of experts-consultants and parties concerned)

19. November 25-27, 2004

Regional Congress on Forestry «Foresry Policy: Matters and Decisions» (Bishkek, Kyrgyzstan)

20. December 11-12, 2004

First Meeting of NGO’s on matters related to GMO’s and biosafety

21. December 24, 2004

Workshop-meeting «Transgenetic organisms and the matters on consolidation of efforts in the national biosafety system

22. January 26 2005

5th NCC Meeting

23. February 9 2005

Development of mechanisms on interdepartmental and intersectoral interaction for the implemementation of the Central Asian initiative on sustainable development

24. March 3, 2005 Working Meeting «Transgenetic organisms and the matters of consolidation of efforts in the national biosafety system (Osh)

25. March 4, 2005 Working Meeting «Transgenetic organisms and the matters of consolidation of efforts in the national biosafety system (Jalal-Abad)

26. March 14, 2005 Working Meeting «Transgenetic organisms and the matters of consolidation of efforts in the national biosafety system (Naryn))

27. March 16,2005 Working Meeting «Transgenetic organisms and the matters of consolidation of efforts in the national biosafety system (Karakol))

28. March 19, 2005

Working Meeting «Transgenetic organisms and the matters of consolidation of efforts in the national biosafety system (Talas)

29. March 14-17, 2005 г.

International Workshop «Sustainable development and use of natural resources in mountainous ecosystems» (Granada, Spain)

30. April 2005. 6th NCC Meeting 31. April 2005 г. Final workshop on biosafety

List experts and consultants of the project

№ Name Position 1. Abdurasulov Yrysbek Internmational Institute of Mountains of the Kyrgyz Republic 2. Azykov Toktogul World Bank Project «Promotion of facilitative services in

agriculture» 3. Aitmurzaeva Dinara National Institute of Standards and Metrology of the Kyrgyz

Republic 4. Aldashev Almaz Scientific and Research Institute on molecular biology and

medicine 5. Alibakieva Cholpon Ministry of Ecology and Emergencies of the Kyrgyz Republic 6. Anarbaev Abdymalik Ministry of Agriculture, Water Resources and Processing Industry

of the Kyrgyz Republic 7. Arzybaev Momun Center on Biotechnology, Kyrgyz Agricultural University 8. Arziev Joromamat Institute of New Technologies of South Division of the National

Academy of Sciences of the Kyrgyz Republic 9. Attokurov Aibek NGO “Protection and preservation of mountainous forests” (Osh) 10. Ahmatov Medet Botanical Garden of the Kyrgyz Republic 11. Ahmetov Uran Ministry on Economical Development, Industry and Trade of the

KR 12. Barakanov Boris Kyrgyz Scientific and Research Institute on cattle breediing,

veterinary and pastures 13. Bektemirov Alimjan State Forestry Service of the Kyrgyz Republic 14. Bektemirov Anarbek Seed Association of the KR

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Chapter 5. Information on the project implementation 15. Borkoev Bakyt Jalal-Abat State University 16. Bortzova Svetlana NGO «Independent Ecological Expertise» 17. Burhanov Aitkul State Foresry Service of KR 18. Bykovchenko Yuriy Institute of Biotechnology of the National Academy of Sciences 19. Vorobyev Gennadiy Independent expert 20. Davydova Lyudmila Department of the state sanitary and epidemiological control under

the Ministry on Health Care 21. Djanuzakov Kanat Ministry of Ecology and emergencies of the KR 22. Eletzkyi Anatolyi Ministry of Agriculture, Water Resources and Processing Industry

of the Kyrgyz Republic 23. Jancharov Dairbek Department of Veterinary under the Ministry of Agriculture, Water

Resources and Processing Industry of the Kyrgyz Republic 24. Junusova Mira Scientific and Research Institute under the Ministry of Agriculture,

Water Resources and Processing Industry of the Kyrgyz Republic 25. Junushov Asankadyr Institute of Biotechnology of the National Academy of Sciences 26. Idrisov Nookatbek International Center on Non-commercial law 27. Ismailov Sharshenbek Kyrgyz Scientific and Research Institute on cattle breediing,

veterinary and pastures 28. Ismanova Mira Joint stock Company «Shoro» 29. Kasymov Omor Scientific and Production Union “Prophylactic Medicine” under the

Ministry on health Care 30. Kachibekov Ulanbek State Commission of KR on Quaratine of Plants 31. Kenjebaev Sovetbek Institute of Biosphere of South Division of the National Academy

of Sciences 32. Kiseleva Rimma Ministry on Economical Development, Industry and Trade

33. Kojekov Erkinbek State Agency of Science and Intellectual Property under the

Government of KR 34. Kocherbaeva Irina NGO «Global and Local Information Partnership» 35. Kochetkova Tatiyana Sate Seed Inspection under the Ministry of Agriculture, Water

Resources and Processing Industry 36. Kuznetzova Lyudmila State Commission on Plants Quarantine under the Ministry of

Agriculture, Water Resources and Processing Industry 37. Kuchuk Tatiyana Scientific and Production Union “Prophylactic Medicine” under the

Ministry on health Care of KR 38. Mansurova Alymkan Ministry of Agriculture, Water Resources and Processing Industry 39. Matveenko Mihail Independent expert 40. Moldogazieva Kaliya NGO, Center on Human Development «Tree of Life» 41. Moldosanova Gulsun Independent expert 42. Musuraliev Turatbek State Foresry Service of KR 43. Omorov Roman State Agency of Science and Intellectual Property under the

Government of KR 44. Ostroborodoa Lyudmila National Statistical Committee of KR 45. Pehota Arnold Ministry of Agriculture, Water Resources and Processing Industry 46. Rudenko Vyacheslav State Seed Inspectorate of the Ministry of Agriculture, Water

Resources and Processing Industry 47. Rustembekov Omor Department on Ecology and Natural Resources of the Ministry of

Ecology and Emergencies 48. Ryskulov Kuttubek State Foresry Service of KR 49. Sadykova Asel Institute on Innovation technologies of the State Agricultural

University 50. Sarymsakov Manas Ministry on Economical Development, Industry and Trade of KR 51. Slepchenko Sergey Trade and Industry Chamber 52. Suigunbaeva Gulmira Jalal-Abat State University 53. Sultanalieva Elvira Ministry of Justice of KR 54. Surappaeva Venera State Foresry Service of KR 55. Sydygalieva Jyldyz Ministry of Foreign Affairs of KR 56. Tkachenko Elena State Seed Inspectorate of the Ministry of Agriculture, Water

56


Resources and Processing Industry 57. Toktoraliev Biymyrza Osh Technological University 58. Toktoraliev Asanbek Jalal-Abat State University 59. Urkunbaev Shailoobek Department of Medicinal Supply of the ministry on Health Care 60. Khudaibergenova

Aisana Independent Expert

61. Sharshenova Ainash Scientific and Production Union “Prophylactic Medicine” under the Ministry on health Care of KR

62. Shukurov Emil Ecological Movement of Kyrgyzstan «Aleyne»

List of material published within the framework of the project № Title Authors

1. Cooperation of the Kyrgyz Republic with international organizations on biosafety issues

Djanuzakov K.

2. Seventh Meeting of the Conference of Parties on Biological Diversity Musuraliev T. 3. Biotechnology: results and perspective Vorobyev G. 4. Genetic Revolution Vorobyev G. 5. On genetically modified products Mansurova A. 6. Alternative directions of agriculture, pharmeceutical and food

industry (traditional knowledge) in the light of application in economical activity of genetic engineering subject matters

Kojekov E.

7. Review of the legislation of KR relevant to genetic engineering and GM-products

Idrisov N.

8. Information on the work of the first Meeting of Parties of Cartagena Protocol on Biosafety

Burhanov A.

9. Informative report of the project UNEP/GEF «Development of National Biosafety Framework in the Kyrgyz Republic»

Djanuzakov K.

10. Biological diversity of mountainous regions Musuraliev T. 11. Genetically modified organisms in natural environment: potential and

and myths, regional expectations and risks Hudaibergenov A..,

Vorobyev G. 12. GMO matters in the Kyrgyz Republic Aldashev A. 13. Matters on genetically modified seed in seed production Rudenko V. 14. Situation with GMO’s in the sphere of medicine Sharshenova A. 15. Biodiversity and biosafety of Kyrgyzstan : matters and tasks Abdurasulov Y. 16. Transgenetic plants and animals and their importance in agriculture Arzybaev M. 17. Social and economical aspects of GMO’s application Slepchenko S. 18. Temptation (point of view of the ecologist on the matters related to

genetically modified organisms) Shukurov E.

19. Cartagena Protocol – the basis on national capacity building on biosafety in KR

Moldosanova G.

20. What is the GMO’s and for what purposes are they created? Jetigenova A. 21. Potential risks for the environment and human health Jetigenova A. 22. Codex Alimentarius genetically modified food Working group 23. Precoutionary principle – to practice Working group 24. Capacity building for the implementation of Cartagena Protocol on

biosafety in KR Working group

25. Ecologists are united into International Alliance «For biosafety» Working group 26. Booklet «What is the National Biosafety Framework?» Working group 27. Booklet «Advantagous and risks of transgenetic plants» Working group 28. Booklet «On Cartagena Protocol on Biosafety» Working group 29. Booklet «Tekter aralyk osymdyktor alardyn paidacy jana

tobokelchiliki” Working group

30. Biosafety of KR (National Survey) Vorobyev G., Hudaibergenov A.,

Matveenko M., Moldosanova G.,

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Kojekov E., etc. 31. Ecologists raise the alarm Soltoeva A. 32. Chet eldik uu azyktardan orustar arylyp jatyshat, a kyrgyzdar ali

oylono elekpiz … Hudaibergenov A.

33. Syrttan tashylgan azyk-tylektordu kozomoldoogo mezgil jetti … Dosnazarov E. 34. Secrets of genetics, or soya war Borisenko L. 35. Products mutants – boon or harm? Hudaibergenov A.,

Ermolov A. 36. Globaldyk maselelerdy chechcindy araketter chechet Rustembekov O. 37. «Food of Franckenshtain» Hudaibergenov A.,

Ermolov A. 38. Be afraid of danaites, brining gifts! (genetic engineering and biosafety

matters) Hudaibergenov A.,

Ermolov A. 39. Do not eat tomato – you become mutant Bakirova R. 40. Biosafety. Science. Economy. Law Working group 41. Tomato from test-tube Hudaibergenov A.,

Pavlovich L. 42. Draft law of the Kyrgyz Republic “On Biological safety” Working group 43. Transgenetic plants and their biological importance Ahmatov M. 44. Biodiversity of Kyrgyzstan and food security and safety Hudaibergenov A. 45. Social risks arising from utilization in the country of genetic

engineering products Matveenko M.

46. Biodiversity management on access to biological resources and their fair distribution

Hudaibergenov A., Matveenko M.

47. Ways to deal with biosafety in Kyrgyzstan

Hudaibergenov A., Matveenko M.

48. What could be planted that could be eaten

Rudenko V.N., Djanbolotova A.

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Annexes

Annex I

THE DECISION OF THE GOVERNMENT OF THE KYRGYZ REPUBLIC

Dated November 29, 2004 №871 Bishkek, the Government House

On the draft law of the Kyrgyz Republic «On accession of the Kyrgyz Republic to Cartagena Protocol on Biosafety of the UN Convention on Biological Diversity»

According to Article 64 of the Constitution of the Kyrgyz Republic, laws of the Kyrgyz Republic «On international agreements of the Kyrgyz Republic and «On normative legal acts of the Kyrgyz Republic» Government of the Kyrgyz Republic decides:

1. To agree with draft law of the Kyrgyz Republic «On accession of the Kyrgyz Republic to Cartagena Protocol on Biosafety of the UN Convention on Biological Diversity».

2. To submit the specified draft law to the Parliament Jogorku Kenesh of the Kyrgyz Republic for consideration.

3. To appoint the Minister of Ecology and Emergencies of the Kyrgyz Republic and the Chairman of the State Forestry Service of the Kyrgyz Republic as official representatives of the Government of the Kyrgyz Republic for consideration of specified draft law by Jogorku Kenesh of the Kyrgyz Republic.

The Prime Minister N.Tanaev

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Annexes

Annex II draft

LAW OF THE KYRGYZ REPUBLIC On Biological Safety

Present law regulates types of activities related to safe creation of living modified organisms

(genetically modified organisms – LMO’s/GMO’s) by genetic engineering methods, their testing, usage in closed systems and introduction to the environment, realization and transboundary movement as well as determines competence of entities that ensure its implementation for the protection of human health and biological diversity and limits the risks of negative impact on ecological balance and the quality of the environment.

CHAPTER 1. General provisions

Article 1. Basic notions used in the present law Accident – biological and social accident that lead to considerable incidental release to the environment of living modified micro organisms/organisms during their usage in closed systems or transboundary movement, and having serious threat for human health and environment; biological safety (hereinafter biosafety) – protection of human beings, animals, plants and environment based on the arrangements aimed at prevention of possible negative consequences and provide effective use of achievements in the field of genetic engineering (bio-engineering); buffer zone – territory, surrounding the places where transgenetic organisms were introduced, under the permanent control (monitoring) over the process of possible distribution or other any other impact to ecological terms and conditions of bordering territories. One of methods on risks management; Clearing House Mechanism on Biosafety – depository of information and key instrument for the implementation of Cartagena Protocol on Biosafety, aimed at promotion of international exchange of information and experiences on the national biosafety systems creation as well as assistance to Parties in implementation of Cartagena Protocol provisions; competent Authority – Intersectoral Coordination Consultative Council (Commission) on biological safety that carries out coordination and development of measures on biosafety, including risks assessment, consequences of release into environment, effectiveness of the control and monitoring of LMO’s/GMO’s; derivative product from living modified organism – the product released into the market that comprise one living modified organism or combination of such organisms that contain living components, capable for transfer or replication of genetic material, used for medicinal or veterinary purposes or in biosynthesis (LMO’s/GM-product) or assigned for direct utilization as food or feed or for processing; field trial – experiment, aimed at studying of living modified organisms in fields under control and guarantees that these organisms will not exist in the environment after the experiment completion; genetic engineering (bio-engineering) - modern biotechnology with application of:

- in vitro methods with use of nucleic acids, including desoxyribonucleic acid (DNA) and direct injection of nucleic acids into cells or organelle, or

- methods, based on fusion of cells with different taxonomic status, which are not determined as methods traditional for derivation and selection, but of those which allows to overcome natural physiological reproductive and recombinant barriers;

Incidental introduction into environment – any cases of release into environment of living modified organisms or their combinations that happened incidentally. introduction – purposive or incidental transfer and/or successful implementation of any alien organism into local natural complexes (potentially receiving environment)

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Annexes living modified organism or genetically modified organism or transgenetic organism (LMO’s/GMO’s) – any living organism/microorganism possessing new combination of genetic material, obtained due to use of genetic engineering methods (bio-engineering); LMO’s/GMO’s Register – specialized list of transgenetic organisms passed expert assessment as to potential risks relevant to influence on human health and environment, with determination of economical application and measures aimed at maintenance of biosafety regime; National competent authority (ties) – administrative system established to ensure implementation of the duties and responsibilities at the national level arising from legally binding acts relevant to implementation of measures on biological safety in cases where living modified organisms are used; National System on Biosafety - combination of political, legal, administrative and technical principles, regulatory mechanisms, procedures, rules and norms that guarantees adequate level of protection, control and monitoring relevant to safe creation, testing, transportation, handling and utilization of transgenetic organisms, that can negatively impact on preservation and sustainable use of biodiversity and environmental conditions taking into account risks on human health within the territory of the state; notification – the document by virtue of which an entity (User) informs Competent Authority on activities planned in order to obtain permission. organism – any form of biological existence capable to self-reproduction and/or transfer of hereditary factors (genetic material), including microorganisms, sterile organisms, plasmids, viruses, viroids, cell cultures, handles, seeds, tubers; potentially receiving environment – ecosystems and agrocoenosis or new biotope, including human beings and animals, which are possibly could contact with released organism; prior informed consent (PIC) – internationally validated procedure and response of the Competent Body on import Notification, that provided for decision making process on import permission; processed genetically modified product (GM-product) – product suitable for identification obtained by the way of LMO’s processing or certain parts of produced metabolites and substances that contains inorganic transgenetic components; purified product – the product, obtained from living modified organisms by way of processing, including purification from transgenetic components; purposive introduction into environment (introduction) – purposive distribution or release into environment of living modified organisms (LMO’s) or their combinations, which is on the basis of expert assessment does not require application of specific measures relevant to isolation and characterized with high level of safety for human health and environment; regulatory regime – legal norms and institutional arrangements on regulation of transgenetic organisms turnover and activities connected thereof; release to the market – supply upon payment or free of charge for the purpose of introduction into production and turnover of living modified organisms, including usage in closed systems or for the purpose of introduction as well as derivative products thereof; risk level – scientifically validated authenticity of potentially harmful impact emergence on human health and environment during the process of genetic engineering activities and utilization of living modified organisms; risks assessment – assessment of direct or indirect consequences of utilization in a closed systems or release into environment, including release to the market of living modified organisms or derivative products for human health and environment; risks regulation – development and application of complex measures aimed at limitation of risks in case of LMO’s release and application as well as precautionary and operative measures taken with regard to accidents and release of living modified organisms; transboundary movement of living modified organisms – any movement of living modified organisms or combinations thereof as well as derivative products from the territory of one state to the territory of another state;

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Annexes user – legal or physical person that carries out and liable to activities related to creation, testing, production, cultivation and realization of transgenetic organisms in a closed and non-closed systems, and also with receiving, testing production and marketing of derivative products of these organisms; utilization in a closed systems – any operation carried out in the frame of construction or any other physical structure related to living modified organisms/ microorganisms, which is regulated by special measures that effectively limits their contact and influence to the environment; utilization of genetically modified organisms – activity or activities aimed at creation, release to the market and utilization in a closed systems and introduction (cultivation) of living modified organisms and their derivatives that contain living modified components, including research, testing, industrial production and economical activity; zone of genetic security – territory where any activities are prohibited, related to use of transgenetic organisms (strictly protected areas) and/or territory, where introduction of transgenetic organisms relative to its wild species is prohibited (centers of origin for cultivated plants); Article 2. Legislation of the Kyrgyz Republic on biosafety Legislation of the Kyrgyz Republic on biosafety based on the Constitution of the Kyrgyz Republic consists of the present law, other legal acts, as well as international agreements recognized by Kyrgyz Republic. Article 3. The scope of activities subject to regulation 3.1. Provisions of the present law covers the following types of activities:

- genetic engineering activity on living modified organisms creation, their testing and implementation into production;

- usage of living modified organisms in a closed systems, including different processes of biosynthesis;

- introduction or release into environment, utilization in economical activities and turnover in the open systems of living modified organisms, including any structures capable to the self-reproduction;

- destruction and burial of living modified organisms and utilization of wastes from genetic engineering activity;

- transboundary movement and transit of living modified organisms, including import/export of living modified organisms assigned for direct usage as food or feed or for processing.

3.2. The present law does not cover the following organisms and activities: - organisms and products obtained by the methods of genetic engineering and used in

pharmaceuticals for human beings and veterinary; - activity on movement regardless of the methods of transportation as well as operations on

import/export, which are regulated by other legal acts except norms relevant to biosafety of the Kyrgyz Republic, in case of existence of living modified organisms or their living components;

- operations with living modified organisms and their derivations which are in accordance with regional or multilateral Agreements regarding transboundary movement and recognized by the Interdepartmental Consultative Commission as safe and not capable negatively impact the preservation and sustainable utilization of biological diversity and human health;

- operations with products, processed transgenetic product or purified products regardless of application sphere excluding measures aimed at biosafety provision in the presence of living modified organisms;

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Annexes 3.3. Requirements provided for in the present law shall not create barriers for international trade and

business activities in a bigger extent than it is marginally provided for the implementation biosafety regime;

Article 4. Risk level identification 4.1. For the purpose of identification and assessment of living modified organisms (LMO’s) potential

impact to the environment and human health during the implementation of genetic engineering activity and their utilization in a closed systems as well as introduction into environment, four risk levels are established:

- 1st risk level - activity and organisms, which are not subject of threat for human health and environment;

- 2nd risk level - activity and organisms with low level of threat and risk for human health and environment;

- 3rd risk level - activity and organisms with medium level of threat and risk for human health and environment;

- 4th risk level - activity and organisms with high level of threat and risk for human health and environment or possibly capable to appear.

4.2. Arrangements aimed at preventive protection, order and conditions of certain risk level determination are provided for in the Regulations on Biosafety Regime approved by the Government of the Kyrgyz Republic.

4.3. Methods on risks assessment and compliance of applicable protection measures from negative effect of living modified organisms have to be reconsidered periodically, and also in those cases where evidences exist on unfair risk assessment. Under this condition new scientific and technical data has to be taken into account. Risk level of the Register of living modified organisms and the Manual for testing and expert assessments are subject to approval by the Intersectoral Consultative Commission.

4.4. Legal entities that carry out genetic engineering activity or utilize living modified organisms in a closed systems rating to the 3rd and 4th risks level shall get the permission only if they have license issued in accordance with legislation of the Kyrgyz Republic.

Article 5. Licensing of the activity dealing with living modified organisms. Activities with living modified organisms pertained to the 3rd and 4th risk levels as highly toxic materials are subject to licensing, including:

- creation, testing, distribution on the market of living modified organisms pertained to the 3rd and 4th risk levels and synthesis on their basis;

- utilization, placing, destruction and burial of wastes from arised from activities pertained to the 3rd and 4th risk levels;

- transportation including importation of living modified organisms, pertained to the 3rd and 4th risk levels.

CHAPTER 2. State management in the sphere of biosafety provision

Article 6. Competence of the Government of the Kyrgyz Republic in the sphere of biosafety provision

regulation To the competence of the Government of the Kyrgyz Republic in the sphere of biosafety provision pertained the following types of activities:

- provision of the state regulation and control in the field of biosafety; - approval of regulatory acts aimed at development and improvement of the biosafety

system;

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- policy orientation on biological diversity preservation and biosafety provision within the country;

- coordination of the state and local authorities’ activities on the matters related to the biosafety provision;

- approval of the state programs on biosafety provision, financial and technical assistance of arrangements having state importance in the sphere of genetic engineering activities and biosafety;

- determination of competent administrative authorities aimed at implementation of the present law;

- approval of the Regulations on Intersectoral Coordination Council (Commission) and Biosafety Regime;

- organization of international cooperation aimed at promotion of genetic engineering activities and improvement of biosafety regime;

- implementation of these functions in accordance with the legislation of the Kyrgyz Republic.

Article 7. Intersectoral Coordination Body 7.1. Intersectoral Coordination Council (Commission) is established under the Government of the

Kyrgyz Republic and carries out functions of the Competent Authority. 7.2. Intersectoral Coordination Council (Commission) comprises of representatives of ministries,

agencies, organizations and other competent bodies providing biosafety within the country. Regulations on Intersectoral Coordination Council (Commission) determine representation, order and regime of its functions and the Regulations are subject to approval by the Government of the Kyrgyz Republic.

7.3. Intersectoral Coordination Council (Commission) under the Government of the Kyrgyz Republic: - assists to the implement the state policy in all sectors of the economy on matters related to the

safe application of bio-engineering technologies; - carries out consultations of state bodies on biosafety matters; - carries out the functions of the Competent Authority and coordinates activities of Competent

Administrative Bodies on control over the biosafety regime; - develops draft regulatory acts on bio-engineering technologies and biosafety; - develops criteria, rules and procedural mechanisms on expert risk assessment, processing of

notifications and granting permits, registration and maintenance of the Register of living modified organisms, classification as for risk level, handling, release and introduction of transgenetic organisms;

- determines risk levels for activities and particularly for specific living modified organisms on the basis of tests and expert assessments taking into account expert recommendations and guidelines developed by the relevant international agencies;

- coordinates and improves control systems in the field of biosafety; - issues permits and refusals on the basis of Notifications and requests based on expert

decisions of Competent Administrative Bodies on genetic engineering activities, utilization of living modified organisms in a closed systems, introduction into environment and transboundary movement of living modified organisms.

- carries out control over the creation of information databases in Competent administrative bodies and their interaction with Clearing House Mechanism on biosafety;

- in collaboration with competent administrative body participates in representation of the Kyrgyz Republic as the party in international agreements in the sphere of biosafety and biodiversity;

- responsible for the implementation of obligations on reporting and information exchange arising from international agreements on biosafety.

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Annexes 7.4. Organizational and technical maintenance of Intersectoral Coordination Council’s (Commission)

work will be carried out by the Ministry of Ecology and Emergencies of the Kyrgyz Republic which will execute the functions of the National Agency in accordance with the requirements of international legal acts.

Article 8. Special competent administrative bodies. 8.1. Implementation of the present law will be carried out by the special competent administrative

bodies in accordance with legislation of the Kyrgyz Republic. 8.2. Council on National Security:

- carries out control and organizes preventive measures to avoid biological terrorism with use of living modified organisms;

- carries out control over the emergency measures in case of large emergency conditions having potential transboundary danger of living modified organisms impact on ecological conditions of the region.

8.3. State Agency of Science and Intellectual Property: - determines general requirements, taking into account development of scientific knowledge, to

normative and legal maintenance aimed at development and regulation of genetic engineering researches and bio-engineering technologies;

- evaluates perspectives of priority directions in genetic engineering development and carries out preliminary risk assessment of new technologies;

- carries out examination of applications on execution of genetic engineering activities (research and creation of living modified organisms, their testing and implementation into production) and submit Decision to the Intersectoral Coordination Council (Commission) after the completion of Notifications processing;

- Carries out control and coordination of bio-engineering researches and maintain the registration of bio-engineering researches pertained to 3rd and 4th risk levels;

- maintain the Register of all created in the country and imported living modified organisms, that are passed testing and expert assessment in accordance with the Regulations on biosafety regime.

8.4. Ministry of Ecology and Emergencies: -carries out control over the environmental protection from negative impact arising possible

and application of living modified organisms and execute monitoring of environmental conditions in zones of their introduction;

- carries out control over the safety of technologies and technological processes of biosynthesis and genetic engineering activity;

- maintains the Register of Experts on Environmental Impact Assessment and realizes its competence regarding ecological expertise requirements with regard to environmental impact by representation in all expert commissions on risk assessment during the process of Notifications (applications) consideration for getting Permits on use of living modified organisms.

8.5. Committee on Revenues under the Ministry of Finance: - carries out custom control over transboundary movement of living modified organisms and

compliance of labeling in accompanied documents. 8.6. Ministry of Health:

- carries out state sanitary and hygiene expertise and risk assessment of living modified organisms impact on human health;

- maintains the Register of experts on impact assessment of living modified organisms on human health and realizes its competence on human health protection by representation in all expert commissions during the process of Notifications (applications) consideration for getting Permits on genetic engineering activity and use of living modified organisms;

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- carries out registration and informative analysis of living modified organisms potential danger and their derivative products obtained as well as possible impact on human health of processed products produced for human consumption.

8.7. State Forestry Service: - maintains the control and monitoring over the living modified organisms introduction

consequences into environment and analysis of potential impact on biodiversity; - carries out control over the regime on biodiversity protection and prohibition on release into

environment of living modified organisms in the zones of genetic security; - maintains the Register of experts on impact assessment on biodiversity and realizes its

competence on biodiversity protection by representation in all expert commissions on Notifications (applications) consideration on release (introduction) of living modified organisms;

- carries out registration and informative analysis of the potential danger on biodiversity of all living modified organisms.

8.8. Ministry of Agriculture, Water resources and Processing Industry: - provides state testing, registration and expert risk assessment of living modified organisms

impact and preparation created on their basis (plant varieties, animal breeds, microbiological agricultural and veterinary preparations and plant protection means) by the relevant subordinate structures;

- provides phytosanitary and veterinary control over the transboundary movement and security rules during the introduction and release in agricultural production of living modified organisms;

- carries out control over the safe application of living modified organisms, including microorganisms, in agronomical sector, biosynthesis process and processing industry, independently from form of ownership of the organization or an enterprise;

- maintains the Register of Experts on sort diversity impact assessment and provides with participation of all stakeholders expert risk assessment on Notifications (applications) on release (introduction) utilization in a closed systems and import of living modified organisms for submission of the Decision to Intersectoral Coordination Council (Commission);

- provides sufficient period for studies and safe field trials execution and maintains the Register of living modified organisms implemented into agricultural production and plant varieties register, including imported from other countries and passed testing with designation of requirements on safe application and the characteristics of the products obtained from them;

- carries out registration and informative analysis on potential negative impacts on biodiversity, countries sort diversity taking into account the risks on human health of living modified organisms, capable for penetration to territory of the country, including living modified organisms aimed for direct use as food or feed and processing on local enterprises.

8.9. National Academy of Sciences: - coordinates all scientific researches in the field of genetic engineering and determines priority

directions of development, including critical technologies; - participates in expert assessment of applications on activities and risks assessment of living

modified organisms application. 8.10. Competent body on technical regulation:

- coordinates activities on preparation of draft legal acts and organizes preparation and reconsideration of technical regulations in the field of biosafety regime implementation.

CHAPTER 3. Mechanism on Notifications (applications) handling and decision making.

Article 9. Notification handling.

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Annexes 9.1. All types of activities regulated by the present law, carried out upon Permits granted by the

Intersectoral Coordination Council (Commission) on the basis of Decisions on expert assessment, conducted by the special competent administrative bodies in accordance with regulations provided for in the Regime on Biosafety approved by the Government of the Kyrgyz Republic.

9.2. For organization of activities on genetic engineering researches, creation, testing and release into the market, application in a closed systems, field trials, introduction of living modified organisms User is obliged to conduct assessment of this activity as for safety on human health and environment with determination to one of the risk levels provided for in Article 5, and submit to the Special competent administrative body, as for transboundary movement of these organisms for the purpose of introduction directly to the Intersectoral Coordination Council (Commission) Notification (application) with all necessary information provided for in the Regulations on Biosafety Regime. Copy of Notification has to be forwarded to the territorial local authorities for public awareness.

9.3. Types of activities that require Notification for getting Permits and Special competent administrative bodies executing expert assessment are determined in the Regulations on Biosafety Regime.

9.4. In the Notification (application) on execution of genetic engineering researches, creation and testing in a closed systems, as well as import for researches and conducting genetic manipulations with living modified organisms sent to the State Agency of Science and Intellectual Property, User describes the character of researches and the potential in accordance with Article 14 of the present law, and also propose draft arrangements on provision of security of the staff and environment as well as procedures on emergency situations.

9.5. In the Notification (application) for the first field trial, first release to the market and application in a closed systems and for introduction forwarded in accordance with specificity of usage to the Ministry of Agriculture, Water Resources and Processing Industry or to the Ministry of Health, User has to present information with Enclosures, determined by the Regulations on Biosafety Regime. In the Notification (application) for the first import supply of living modified organisms, aimed for introduction, sent directly to the Intersectoral Coordination Council (Commission), importer has to submit information in accordance with Regulations on Biosafety Regime, including full informative set of documents on activity, that requires application of the procedure on prior informed consent (transboundary movement for the purpose of introduction). Notification (application) for the first import supply for introduction purpose to the Intersectoral Coordination Council (Commission) after registration and delivery of the Confirmation to the applicant and submit to the Special Competent Administrative Body for expert risk assessment and preparation of the Decision. In the attachments to the Notification (application) for the first release to the market, including imported and application in a closed systems and introduction User has to submit:

- approved specificity of living modified organism application and expected use or characteristics of derivative products as well as the copy of the Register on living modified organisms;

- previous or existing report on researches and tests before release to the market and expert risk assessment, including description of possible adverse effects from genetic manipulations and also, if necessary, reports and Expert Groups risk assessment or Complex Expert’s Commission upon completion of field trials;

- terms and conditions relevant to the measures taken with regard to prevention of potential risks and methods aimed at provision of safe handling, storage, transportation and utilization, including procedures on destruction and utilization of wastes;

- if necessary, draft arrangements in case of emergencies.

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Annexes 9.6. Applicant is responsible for the accuracy of information as well as information requested

additionally and presented to the Intersectoral Coordination Council (Commission) through Notification or by any other way.

9.7. Special competent administrative body considers compliance of Notification (application) to the requirements provided for in the Regulations on Biosafety Regime, accuracy of risks assessment, protection measure and measures that are applicable in case of an accident, wastes management and also, if necessary, carries out additional examination and presents Decisions to the Intersectoral Coordination Council (Commission) for decision making.

Article 10. Procedure on decision making 10.1. Before granting the Permit on utilization of living modified organisms by the Intersectoral

Coordination Council (Commission) on the basis of the Decision issued by Special Competent Administrative Body, if necessary, additional examination could be taken – with regard to relevant measures aimed at prevention of negative impact on human health and environment (biodiversity) out of place where equipment is located.

10.2. Intersectoral Coordination Council (Commission) during the time period provided for in the Regulations on Biosafety Regime, communicate Confirmation to the applicant in written confirming the receipt of Notification.

In the Confirmation, except time periods of receipt, consideration and decision-making the following points are designated:

1) as to compliance of Notification to the requirements provided for in the present law and Permission granted in accordance with certain terms and conditions or without them;

2) applicant has to present additional information, including clarification of risks assessment, and/or

3) activity on which permission is requested requires risks assessment report or additional testing; or

4) activity on which permission is requested is not covered by the present law and Notification is rejected; or

5) activity on which permission is requested is not covered by the present law. 10.3. Permission on import, release to the market, and handling of living modified organisms and/or

derivative products thereof granted only on the basis of following terms and conditions: - compliance of designated organisms and their derivative products to the norms (standards)

of national legislation, in case of absence , to international acts and other documents; - compliance to the requirements relevant to risks assessment as for human health and

environment; - availability on the package and/or in accompanied documents of relevant labels and precise

description on specific terms and conditions of application. 10.4. On each living modified organism or product which is contain the same living modified

organism or combination thereof, consist them or in combination, but aimed at other type of use, Notification has to be submitted separately.

10.5. Applicant can start his activity only after receipt of Permission, granted by Intersectoral Coordination council (Commission), in accordance with procedural requirements provided for in Regulations on Biosafety Regime, and, if necessary, with implementation of established order on granted on special cases, that will accompany activity and realization of products produced thereof.

10.6. Fees on consideration of Notifications and granting Permits, as well as licensing of activities in the field of genetic engineering are determined in accordance with legislation of the Kyrgyz Republic and will be transferred to the budget.

CHAPTER 4. Ensure security during the tests and

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mechanism on expert risk assessment Article 11. Security maintenance during the tests 11.1. Implementation to the production, release to the market and subsequent utilization in closed

systems for the purpose of introduction maintained by way of testing, including: - created within the country living modified organisms have to pass testing in closed systems,

in accordance with granted Permit on genetic engineering activity; - imported living modified organisms for research purposes, genetic manipulations and

limited testing in accordance with Permit granted on import for the purposes of genetic engineering activity;

- created within the country living modified organisms for the purpose of introduction have to pass field trials upon special Permit on field trials;

- imported living modified organisms for the purpose of introduction have to pass field trials as the first stage of procedures on prior informed consent on the basis of Permit on import for filed trials.

11.2. Procedure on field trials making, including imported living modified organism, measures on security maintenance, including, if necessary, wastes destruction are determined by the Regulations on Biosafety Regime.

11.3. Created during the process of genetic engineering activity and imported living modified organism after the tests period have to pass sufficient period of studies, equal to its life cycle or the period of reproduction before its planned implementation into production.

11.4. Field trials, location or water reservoir have to ensure protection of the population health working on these lands and biodiversity preservation, maintain breed and plant diversity due to buffer zones of security.

11.5. Risks assessment and tests analysis has to be conducted by Expert Groups in the following composition:

- during the tests in closed systems participation of sanitarian and epidemiological specialists is mandatory in order to conduct special researches on food safety produced from living modified organisms;

- during the field trials risk assessment has to be conducted by Complex Expert Commission with participation of all stakeholders concerned, including obligatory participation of agronomists on sorts trials and protection of sorts diversity, ecologists – on environmental protection, as well as doctors – protection of human health. Complex Expert Commission carries out researches on determination of possible impact on human health and biodiversity.

11.6. On the basis of tests and additional researches on biodiversity impact, environment and human health as well as analysis of international reports on tests and expert decisions on imported living modified organisms, Expert Group or Complex Expert Group prepares Reports with recommendations on biodiversity protection, including sort diversity and human health, which will serve as the basis for the Decision taken by the Special Competent Administrative body and inclusion into the Register of living modified organisms permitted for distribution in the domestic market and implementation into production.

11.7. On the basis of tests and expert assessment clarification of the risk level is carried out on utilization of living modified organism, eligibility for use, specific of application and derivatives are determined as well as special measures on risks regulation.

11.8. Tests financing and public awareness activities on creation and import of new organisms for the purposes of closed production processes or introduction conducted at the expenses of User (applicant).

Article 12. Expert Risk Assessment

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Annexes 12.1. Risks assessment has to be conducted strictly on the scientifically validated basis, for which

additional information might be of essence, taking into account international standards, recommendations and guidelines, norms and rules developed by the relevant international organizations as well as information of the Clearing House Mechanism on biosafety. Scientific validity of the Report on risk assessment and conducted tests provided by the qualification of experts in Expert Groups or in the Complex Expert Commissions.

12.2. Risk assessment has to be conducted on a transparent manner taking into account requirements provided for in the Guidelines on tests and expert risk assessment on individual basis for each sort, breed, clone which requires determination of any new characteristics capable negatively biological diversity and human health.

12.3. Risks related to living modified organisms, derivative products and processed materials originated from living modified organism has to be considered in the context of risks arising from non-modified parent organisms in the same possible receiving environment.

12.4. For certain types of imported living modified organisms, including 1st risk level, aimed at utilization in production processes of biosynthesis in closed systems or for direct use as food or feed or for processing, prior to the first transboundary movement subject to the risk assessment procedure conducted by the Special Competent Administrative Body with attraction of specialists in the field of health care on the basis of analysis, presented by the User’s (applicant) materials attached to Notification, including report on risks assessment in case of release to the market in the country of export.

Under this term in the Decision could be reflected recommendation on subsequent application taking into account experience of the User and technical maintenance of production processes in accordance with simplified procedure on permissions granting.

12.5. In case of living modified organisms utilization of both created in the country as well as imported, special measures based on risks assessment are introduced for that extent that could be sufficient for the prevention of living modified organisms negative impact on preservation and sustainable utilization of biological diversity taking into account risks on human health.

These measures, if necessary, should be reflected in Decisions prepared by the Special Competent Administrative Body.

12.6. Regulation mechanisms cannot provide measures based on intuition or indefinite assumptions on harm during the long-term utilization in changing circumstances, which do not allow scientifically validate risk’s extent. In this case User of living modified organisms is obliged to inform the consumers on possible harm and depending factors thereof.

12.7. Financial expenses related to expert risk assessment is the sole responsibility of the User (applicant).

Article 13. Register of living modified organisms. 13.1. Order for the maintenance of the register on living modified organisms and copies granting to the

User are determined by the Regulations on Biosafety Regime. 13.2. Living modified organisms that have passed testing and determined as appropriate for safe use in

the production and utilization, including imported, can be released to the domestic market through inclusion into the Register of living modified organisms maintained by the State Agency of Science and Intellectual Property with description of all technologies protected by patents and other rights of intellectual property and all specific terms and conditions of living modified organisms utilization and derivative products.

Access and transfer of genetic resources have to provide terms and conditions which provide sufficient protection of intellectual property rights in accordance with the legislation of the Kyrgyz Republic.

13.3. Decision on inclusion of living modified organisms into the Register can be based on public consultations, under this condition, remarks and comments from civil society can be taken into account during decision-making process.

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Annexes 13.4. Permission on purposive introduction into environment of living modified organisms, granted by

Intersectoral Consultative Council (Commission), is obligatory during the registration of sorts for field trials on agronomical and technological value, conducted by the State Commission on Plant Varieties Testing for the purpose of their production in the Kyrgyz Republic.

13.5. All plant varieties created by the methods of genetic engineering technologies and being living modified organisms, including imported, relevant to terms and conditions of testing on agronomical and technological value, are included into the State Register of the Kyrgyz Republic.

CHAPTER 5. Regulation of the activities in the field of genetic engineering

and utilization of living modified organisms in closed systems

Article 14. The right on activities in the field of genetic engineering and utilization of living modified organisms in closed systems.

The following entities are eligible to conduct activities in the field of genetic engineering and

utilization of living modified organisms in closed systems: - natural persons, health conditions of those and professional qualification could provide safe

activities in this field; - legal entities, having spaces, equipment and qualified staff capable to provide activities in

the terms of safety for the environment and human health. Article 15. Regulation of the activities in the field of genetic engineering 15.1. Regulation in the field of genetic engineering covers the following types of activities:

- genetic manipulations on molecular, cell levels, with use of recombinant ribonucleic and desoxyribonucleic acids for the creation of living modified organisms (viruses, microorganisms, transgenetic plants and animals as well as their cells);

- all types of living modified organisms tests, including laboratory, clinical, field trials, research and development works;

- storage, burial, destruction of those LMO’s that have not pass registration and utilization of water from activities in the field of genetic engineering.

15.2. All works in the field of genetic engineering are carried out on the basis of Permission from the Intersectoral Coordination Council (Commission), granted on the basis of the decision taken by the State Agency of Science and Intellectual Property in accordance with Article 9 of the present law.

Article 16. Regulation of matters related to utilization of living modified organisms in closed systems. 16.1. First use of living modified organisms in closed systems in the processes of biosynthesis on

enterprises attached to the health care system, food and processing industry, including imported , is carried out in accordance with permission of Intersectoral Coordination Council (Commission), granted on the basis of Decision from the Special Competent Administrative Body, including:

- Ministry of Health – carries out expert assessment of Notifications or applications on the first import supply or first implementation into production of LMO’s, including tissue and cell cultures, in the sphere of medicinal preparations synthesis, genotherapy and genodiagnostics;

- Ministry of Agriculture, Water Resources and Processing Industry - carries out expert assessment of Notifications or applications for the first import supply or first implementation into production in closed systems of LMO’s, including bacterial preparations, seeding, derivatives from LMO’s for domestic processing, in food and processing industry.

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Annexes 16.2 Order of Permits getting, terms and conditions, procedures on consideration of notifications

(applications) from natural and legal entities on preliminary tests and utilization of LMO’s in closed systems are determined in the Regulations on Biosafety regime with reference to Articles 9-12.

Procedures and order for Notifications consideration on import of LMO’s for research purposes and creation of new modifications during the activities in the field of genetic engineering are provided for in the Regulations on Biosafety regime taking into account Articles 21-25.

With regard to LMO’s utilization in closed systems provisions of Articles 26-30 applied as well.

Article 17. Safety provision in the sphere of genetic engineering and during the LMO’s application in

closed systems.

17.1. In order to provide safe production processes in institutions, organizations and enterprises local Commissions on biosafety are established aimed at preparation of preliminary risk assessment during the planning and preparation of activities with LMO’s and systematic control on necessary protection level in production processes.

In those cases when numerical composition of institutions, organization or enterprises does not allow establishing the Commission on Biosafety on production processes of the enterprise, these types of organizations, institutions or enterprises could join to one of the existing Commissions with analogous profile of activities upon agreement with the Special Competent Administrative Body.

Typical Regulations on Biosafety Commissions dealing with safe production processes under particular institution (enterprise) are subject for approval by the Special Competent Administrative Body with analogous profile of activities.

17.2. All genetic manipulations in genetic engineering activities and all types of works during the usage of LMO’s in closed systems of 1st and 2nd risk levels subject for registration in the special registration journal of institution (enterprise).

Research and development works, and utilization of LMO’s in biosynthesis processes in closed systems, pertained to the 3rd and 4th risk levels, subject for registration in the Special Competent Administrative Bodies.

CHAPTER 6. Release to the market of LMO’s and their derivative products

Article 18. LMO’s release to the market. 18.1. Before the first release to the market of living modified organisms or derivative products,

Producer, that implements into production, upon certain circumstances, or importer has to submit Notification to the Special Competent Administrative Body, which has to contain the following information:

- information determined by the requirements contained in the Regulations on biosafety regime, as well as data, obtained through research work, tests, development monitoring (during the growing), conducted previously, expert reports on creation and testing as well as obligatory copy of the Register of living modified organisms;

- expert risk assessment of derivative product for human health and biodiversity; - terms and conditions as for release to the market, including concrete specific terms and

conditions of use, handling and transportation as well as recommendations on packaging and labeling.

18.2. Applicant has to include into Notification information obtained as a result of release to the market of the same living modified organisms or combinations mentioned in the Notification or information on previous use outside of the Kyrgyz Republic. Applicant can also make a

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reference on those results, submitted previously in Notifications of other applicants in case of their written agreement.

18.3. Decision on Notification with regard to release of imported LMO’s to domestic market accepted on the basis of expert Decision from the Special Competent Administrative Body:

- for use in closed systems with preliminary Permission granting on import and execution of tests for expert risk assessment in closed systems in accordance with provisions of Articles 12, 21-26;

- for domestic turnover and LMO’s processing and derivative products on the basis of Notification (application) from Importer (User), in accordance with provisions of Articles 22, 23, 26;

- for purposive introduction into environment in accordance with provisions on prior informed consent and preliminary Permit granting on import and field trials, or in exclusive cases without Permit in accordance with Articles 19-26.

18.4. Procedures and order on consideration of Notifications on export of living modified organisms provided for in the Regulations on Biosafety Regime, taking into account provisions contained in Article 23 of the present law.

18.5. With regard to release of LMO’s to the market, provisions provided for in Articles 9-11 are also applicable.

CHAPTER 7. Purposive introduction of living modified organisms into environment

Article 19. Special terms and conditions with regard to LMO’s introduction 19.1. It is prohibited to make LMO’s introduction or any free release to the environment in the zones

of genetic security on strictly protected areas (biosphere reserves, natural national parks or in buffer zones)

19.2. It is prohibited to make introduction and any release into environment of living modified organisms with close relatives to transgenetic sorts into the Zone of the Central Asian Center of Origin of cultural plants in places of origin of their wild relatives.

It is prohibited to make introduction of LMO’s of close relatives of transgenetic sorts to the Zone of Secondary Center of Origin of sort diversity.

List of flora and regions of origin for wild relatives that serves as the basis for cultural sorts and the list of traditional sorts of cultural plants obtained through people’s selection and the regions of their growing are published in the Annex to the Regulations on Biosafety Regime.

19.3. In the arrangements on regulation of biosafety regime in case of transgenetic plants introduction, special importance paid to the prevention of possible pollination with weed and pollutions of neighboring agricultural cultures. Those people, who are guilty for incidental distribution of transgenetic plants, as well as their illegal use as seed of living modified organisms from products aimed for food or feed or domestic processing, are liable in accordance with legislation of the Kyrgyz Republic. In case of introduction of transgenetic animals special measures are provided for with regard to hybridization prevention with wild forms of animals living on the territory of Kyrgyz Republic as well as prevention of other forms of damages to the biodiversity genetic potential.

Article 20. Order of introduction and biosafety maintenance during the release of living modified

organisms.

20.1. Physical and legal entities prior to the first introduction of living modified organisms, created in the country and released in the market or their combinations for the purpose of additional researches, growing for seed and trade products production or for other purposes, have to submit to Intersectoral Coordination Council (Commission) through Special Competent Administrative

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Body, Notification with information provided for by the Regulations on Biosafety Regime with attachment in accordance with provisions of Article 9.

20.2. Introduction of imported living modified organism carried out after long-term procedure of prior informed consent in accordance with Regulations on Biosafety Regime, which is on the first stage includes Permit granting on purposive transboundary movement (import) to conduct field trials in accordance with paragraph 23.3 of Article 23 of the present law.

In exclusive cases for living modified organisms pertained to the 1st and 2nd risk level (seed fund) on the basis of the Decision from the Ministry of Agriculture, Water Resources and Processing Industry, Intersectoral Coordination Council (Commission) is entitled to grant Permit on transboundary movement (import) for direct release to domestic market without preliminary test procedure in accordance with provisions of the present law.

20.3. Living modified organisms aimed at introduction and use for fields sowing, including growing for medicinal purposes and creation of forest plantations for box maintenance of agricultural animals and home keeping, cultivation in ponds and other purposes, has to comply with the following requirements:

- lack of danger for health and environment in case of maintenance of the technology; - capable for identification.

20.4. It is allowed to submit only one Notification in case of introduction into environment of LMO’s in one particular place or the same living modified organisms in different places with the same purpose and during limited time period.

20.5. In case of subsequent introduction of the same living modified organism or the same combination of organisms mentioned previously, User (applicant) has to submit new Notification, and include data contained in the first Notification and monitoring materials of previous introductions. Upon receipt of all these data simplified consideration procedure of Notification could be applied in case if previously granted Permit was not unlimited.

20.6. After introduction into environment of living modified organisms User (producer) has to submit to the Ministry of Agriculture, Water Resources and Processing Industry report on results of introduction for the inclusion to the Register of Zoned and Approved for sowing sorts and hybrids taking into account buffer zones and other established measures provided for in the Permit aimed at biodiversity protection and human health.

Time periods for reports submission on introduction are provided for in the Permit.

CHAPTER 8. Transboundary movement of living modified organisms.

Article 21. State regulation of export/import, transit and movement of living modified organisms. 21.1. Import/export and transit through the territory of the Kyrgyz Republic of living modified

organisms and/or their derivatives that contain living modified components is carried out in accordance with international rules and norms, provided that handling, transportation, packaging and identification has to be executed in a safe manner in order to prevent negative impact on preservation and sustainable utilization of biological diversity and human health. These subject matters have to be accompanied by documentation that comply with international norms.

21.2. Activity on import/export of transgenetic organisms and/or derivatives could be implemented in case of positive execution of terms and conditions provided for in Article 9 and 10 or in those when special requirements are met related to Notification, agreement and Permit established by international legal acts recognized by Kyrgyz Republic.

Transboundary movement (transit) through the territory of the Kyrgyz Republic of living modified organisms and/or derivatives could be implemented after special Notification from the country of export or import.

21.3. Activities on import/export have to comply with the following requirements:

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- application by the Intersectoral coordination Council (commission), if necessary, of the procedure on prior informed consent in accordance with provisions provided for in Articles 9, 10 and 20;

- risks assessment in accordance with provisions provided for in Articles 12 and 26; - observance of requirements on packaging, labeling, transportation and manipulation in

accordance with Article 27; - maintenance of information exchange in accordance with Article 28; - non-disclosure of confidential information and recognition of intellectual property rights in

accordance with Articles 28 and 30; - prevention of illegal transportation, incidental transboundary movement and maintenance of

adequate measures in case of emergencies and accidents in accordance with Articles 25 and 26.

21.4. Importer (user) before importation process has to make sure that exporter of living modified organisms and/or derivative products that contain living modified components comply with the requirements provided for with regard to:

- packaging, identification, labeling and transportation on the level adequate to these type of operations provided for in the national legislation;

- observance of other terms and conditions provided for by the present law. 21.5. Importer has to observe compliance of accompanied documents with requirements provided for

by the national legislation and provisions of international legal acts with regard to transboundary movement of living modified organisms and derivative products with living modified components. Requirements of the national legislation with regard to packaging and labeling of living modified organisms subject to transboundary movement has to be agreed with exporter.

Article 22. Notification of the Competent Body on import and transit 22.1. Importers prior to the first supply of living modified organisms and/or derivative products that

contain living modified components for introduction purposes have to notify in written Intersectoral Coordination Council (Commission). As for import for use in closed systems for food, feed and processing on local enterprises Notification has to be sent through the Special Competent Administrative Body with designation of import purpose.

Procedures, forms of Notifications submission and time periods for Confirmations are provided for in the Regulations on Biosafety Regime and Articles 9 and 10 of the present law.

Prior the first purposive transboundary movement of living modified organisms for introduction (release to the environment) Party of Export regardless of terms and conditions as for Notification submission by the User (importer), has to submit to Intersectoral Coordination Council (Commission) its own Notification in order to initiate prior informed consent procedure.

22.2. Prior informed consent procedure applied before the first purposive transboundary movement of living modified organisms or derivative products that contain living modified components for:

- field trials on the territory of the country; - purposive introduction to the environment (import for the purpose of introduction).

22.3. Party of Export is not entitled to start operations on export to Kyrgyz Republic of living modified organisms for introduction purposes prior the decision with regard to terms and conditions of such export and receipt of prior informed consent.

Article 23. Order on decision making with regard to transboundary movement. 23.1. Decision of the Intersectoral Coordination Council (Commission) on import permission based on

provisions of Articles 10, 21, 26 and 27 and in particular, on risks assessment procedure (Article 12), during the established time period provided for in the Regulations on Biosafety Regime, Confirmation will be sent to the applicant to confirm the receipt of Notification.

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Special Competent Administrative Body on expert risks assessment takes one of the following decisions on import of living modified organisms:

- to grant Permit on import, taking into account certain terms and conditions or without thereof, with clarifications on how they have to be used for further importation of the same genetically modified organism or derivative product; or

- to prohibit importation; or - request submission of additional information; or - extend time period on decision making necessary for analysis making of additional

information received from the applicant or from other sources. With regard to Decision taken applicant will be informed in written.

23.3. In case of import for the purpose of living modified organisms introduction, procedure on prior informed consent initiated by the Notification from the User, divided on two stages:

a) Permit granted for limited import for field trials, conducted in accordance with Regulations on Biosafety Regime and Articles 11 and 12 of the present law.

b) upon results of tests and report of the Complex Expert Commission taking into account provisions of Article 26 of the present law, Intersectoral Coordination Council (Commission):

- grants permit on import for introduction purposes; - prohibits importation of living modified organism.

In exclusive cases in accordance with paragraph 20.2 of Article 20 Intersectoral Coordination Council (Commission) can grant permission on import for direct release to domestic market without passing test procedure.

Order for Notifications consideration on import for introduction purposes, parties of import and export (applicants) will be notified by Confirmation during time period provided for in the Regulations on Biosafety Regime.

23.4. Subsequent transboundary movement of the same living modified organism or the combination thereof, mentioned previously, User (importer) presents new notification only in those cases where previously granted Permit was not unlimited.

23.5. Export of created in the Kyrgyz Republic living modified organisms and derivative products could be done on the basis of regulations adopted by the country of import. Under this condition, exporter is obliged to notify in advance Competent Body in the country of import on planned transboundary movement.

Article 24. Reconsideration of the Decision on importation. 24.1. In case of availability of new scientific information on potential impact of concrete type of living

modified organism to the environment and human health, Intersectoral Coordination Council is entitled to reconsider and change its decision with regard to transboundary movement. In this case Notification would be sent to the User with designation of reasons for new decision.

24.2. Export party or User (importer) are entitled to apply for reconsideration of the Decision on importation, in those cases where export party or User deems that:

- there are certain circumstances arose capable to influence on the results of risk assessment that lead to take a particular decision; or

- there is a new additional scientific or technical information become available. Intersectoral Coordination Council (Commission) has to response in written with

designation of all reasons that lead to take a particular decision. Article 25. Arrangement on cases of incidental movement 25.1. In cases of illegal importation on custom territory of the Kyrgyz Republic of living modified

organisms and/or derivative products thereof, Intersectoral Coordination Council (Commission)

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is entitled to request from country of export to make a decision on their repatriation or destruction at its own expenses and in accordance with norms of international law.

25.2. In case of illegal transportation or incidental transboundary movement of LMO’s and/or derivative products thereof with presence of living genetically modified components Intersectoral Coordination Council (Commission) has to be informed. In this case relevant measures have to be taken by the Commission in accordance with procedures provided for in international legal acts. This information has to be sent to Clearing House Mechanism on Biosafety and relevant measure will be taken in order to prevent any risks with regard to human health and environment.

25.3. Intersectoral Coordination Council (Commission) through the Special Competent Administrative Body disclose public all information on measures to prevent situations, which could arise in case of incidental transboundary movement of living modified organisms and/or derivative products that contain living modified components.

CHAPTER 9. Special requirements to the usage (turnover) of living modified organisms. Article 26. Measures on risks regulation during the use of living modified organisms 26.1. In case of change of terms and conditions on use of living modified organisms capable to impact

human health and environment, or in case of availability of new information on risks, User (applicant) is obliged to:

- reconsider measures provided for in the Permit with regard to risks regulation (terms and conditions stipulated in additional requirements);

- take necessary measures on human health and environmental protection; - inform on these activities Intersectoral Coordination Council (Commission) and the Special

Competent Administrative Body; - present additional information.

26.2. Intersectoral Coordination Council (Commission) is entitled to: - request from the applicant submission of additional information in case of changes in the

previously planned use and/or clarification of the risk level. In these cases Intersectoral Coordination Council (Commission) is entitled to postpone the commencement of activities or stop them in case if these activities are already started on time period, necessary to grant new Permit that adequately reflects new terms and conditions on usage;

26.3. Intersectoral Coordination Council (Commission) is entitled to take steps which are not regulated by the present law or apply simplified procedure of Permits granting in accordance with regional and multilateral agreements on technology transfer and mutually agreed terms and conditions with regard to transboundary movement of living modified organisms and recongnized by Intersectoral Coordination Council (Commission) as safe for preservation and sustainable utilization of biological diversity and human health.

26.4. In those cases where results of any introduction to the environment, use in closed systems or application of living modified organism and derivative products for food, feed or processing, mentioned previously in Notification with granted Permit or on the basis of scientific researches, User (applicant) came to the conclusion that there are no any possible negative impact to the environment and human health, taking into account experience, the User is entitled to request in the Notification not to apply one or several requirements provided for in the regulations on Biosafety Regime in part related to risks assessment , as well as to request simplified procedure on Permits granting.

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risks levels, without development of the Plan and implementation of relevant arrangements on regulation, minimization and control over negative impacts on preservation and sustainable utilization of biological diversity, taking into account human health.

26.6. Creation, transportation, use and handling of living modified organisms are prohibited without preliminary development of the Plan on emergency measures and execution of orders based on expert risk assessment on prevention and liquidation of emergency situations (accidents).

In case of an accident and/or incidental release of living modified organism regardless of risk level, User has to take immediate measures on elimination of emergency situation consequences and inform Intersectoral Coordination Council (Commission) and submit the following information:

- circumstances that lead to an accident; - any other information necessary for the assessment of accident’s consequences; - information on measures taken.

26.7. In case of an accident User has to take measures taking into account Precautionary Principle – absence of valid scientific information on accident consequences with considerable damage is not the basis to avoid actions aimed at prevention of environmental deterioration.

26.8. Intersectoral Coordination Council (Commission) in case of an accident has to take the following actions:

- immediately inform general public, stating the risk level for human health and environment; - execute full assessment of an accident and, if necessary, make recommendations on

prevention of such kind of accidents in future and exclusion of possible consequences; - provide taking necessary measures and, depending on circumstances, immediately inform

competent bodies of neighboring countries that can be touched upon by the same accidents. 26.9. Measures on risks regulation and prevention of incidental release of living modified organisms

have to be provided and implemented not only in those cases where creation, transportation, handling and use of transgenetic organisms takes place, but also during destruction, neutralization and utilization of wastes in accordance with risk level of potential negative impact.

26.10. Resume with regard to safety of living modified organisms could be reconsidered in cases of infringement by physical and legal entities of the Kyrgyz Republic’s legislation in the field of biosafety, as well as in those cases, when scientifically validated information becomes available that could lead to reconsideration of the risk level regarding the impact on human health and environment towards the higher level. In a mean time, as a result of tests and long term monitoring of living modified organism usage, status of unregulated one could be applied or simplified procedure on Permissions granting, in case if scientifically validated full absence of risks on negative impact for human health and environment.

26.11. In those cases where Intersectoral Coordination Council (Commission) after Permit granting, would get information that such type of use takes place with infringement of the present law or in case of serious consequences for human health and environment, Commission is entitled to request from the user to change terms and conditions on use, and if these request is not fulfilled, could take measures to stop or prohibit activities on use of living modified organisms.

Article 27. Requirements provided for with regard to packaging, labeling, transportation and handling

of living modified organisms. 27.1. In case of transboundary movement, transportation within the country and handling in

intermediate points packaging of living modified organisms has to met international standards provided for transportation of dangerous goods taking into account measures on prevention of possible incidental release during the transportation to destination.

27.2. In case of transboundary movement, transit, domestic transportation, release to domestic market and export living modified organisms have to be labeled on packages of small weight traffics or in accompanied documents where have to be designated:

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- living modified organisms for direct use as food, feed or processing - “possibly contains LMO’s/GMO’s but not for introduction” with designation contact details

where additional information could be obtained; - living modified organisms for use in closed systems – “LMO’s/GMO’s for closed systems”

with designation of all requirements for safe handling, storage, transportation and utilization, address of the sender;

- living modified organisms for introduction – “LMO’s/GMO’s for introduction” with designation of all identification data and requirements regarding safe handling, transportation and use, as well as contact details of the importer and exporter.

In case of transboundary movement of living modified organisms, labeling as symbols established in accordance with international standards could be applied.

27.3. In case of transboundary movement of living modified organisms for introduction to the environment in the country of import, exporter have to submit declaration stating that transboundary movement is carried out in accordance with the requirements provided for in the Cartagena Protocol on Biosafety of the Convention on Biological Diversity.

27.4. In all cases related to deal with living modified organisms, including release to the market and use, intellectual property rights have to be observed.

Article 28. Access regime to information on biosafety. 28.1. Procedure on decision-making, expertise and risks assessment on creation and use of living

modified organisms in closed systems and introduction are transparent. Entities that carried out activities in the field of genetic engineering, industrial production and practical utilization of living modified organisms are obliged to present copies of Notification to the territorial local administration stating risk level and arrangements on security maintenance, in accordance with Regulations on Biosafety regime.

28.2. Intersectoral Coordination Council (Commission) coordinates and increases public awareness through mass media by the Special Competent Administrative bodies on results of experts’ risks assessment and tests outcomes. Transparency of genetic engineering activity, creation and use of living modified organisms, importation for the release to domestic market provided for at User’s or Applicant’s expenses.

28.3. Intersectoral Coordination Council (Commission) ensures public participation: comments from general public are accepted during time period provided for in the Regulations on Biosafety Regime and in a recommendation manner are taken into account in decision making process.

28.4. Information on safe use, risks level of production and accepted measures on security maintenance during the handling with produced products is open and publicly available, except those information pertained to secret and confidential in accordance with legislation of the Kyrgyz Republic.

Applicant during the filing of application and submission of additional information on living modified organisms requested by Intersectoral Coordination Council (Commission) could designate certain information as confidential, and in accordance with legislation in the field of intellectual property.

28.5. Decision on recognition of the information provided by the Applicant as confidential will be taken by Intersectoral Coordination Council (Commission) after the consultations with User and exporter. Notification will be communicated on decision taken.

Information regarding general characteristics of transgenetic organism, purposes of use, risk level and expert decisions, security level regarding handling and planned measures in case of emergencies cannot be considered as confidential.

Intersectoral Coordination Council (Commission) and decision makers of Expert Commissions are not entitled to disclose to third parties of any information recognized as confidential and obliged to observe intellectual property rights in accordance with legislation of the Kyrgyz Republic.

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CHAPTER 10. Control over the turnover of living modified organisms and liability. Article 29. Control over the Regime on Biosafety observance on the territory of the Kyrgyz Republic. 29.1. Control over the Regime on Biosafety observance during domestic turnover, transboundary

movement and transit of living modified organisms on the territory of the Kyrgyz Republic is charged on departmental inspectorate services of administrative bodies:

In case of transboundary movement of traffics with living modified organisms through the borders of Kyrgyz Republic – on Custom Service of the Kyrgyz Republic;

In case of genetic engineering activities and use of living modified organisms in closed systems – on inspectorate service of environmental protection and sanitary service;

In case of introduction and domestic movement of living modified organisms and field trials: - on Seed Inspectorate – during the tests and use of new varieties of transgenetic plants;

- on phyto-sanitary control – in case of domestic transportation and monitoring over the release of transgenetic organisms/ microorganisms;

- veterinary control – during tests and monitoring over the release of transgenetic animals and products that used as feed;

- service on chemicalixation and plant protection – during teats and use of living modified organisms for plant protection;

- sanitary epidemiological service – control over the transgenetic products used as food products.

In case of living modified organisms use in closed systems, introduction and domestic movement:

- on state service for the protection of flora and fauna, forest protection and service of strictly protected areas – monitoring and control on biodiversity preservation, observance of the Regimes on biosafety in the zones of genetic security and monitoring of neighboring territories for the prevention of negative ecological impacts of living modified organisms.

29.2. Functions of inspectorate services on accompanied documentation control, traffics packaging, labeling, manipulation during transportation, including transit, field trials and use, storage as well as seed, cell cultures, products processing, liquidation of wastes and release to the market of living modified organisms are determined in the Regulations on Biosafety Regime and Statutes of all control services of the Kyrgyz Republic.

Article 30. Liability for the infringements of the present law 30.1. Natural and legal entities in case of infringements of the present law, liable in accordance with

legislation of the Kyrgyz Republic. Illegal activity on creation, testing, production, use, realization, import/export of living modified organisms and/or derivative products thereof, implies liability in accordance with present law.

30.2. Natural and legal entities, including decision makers, guilty in committing a crime in accordance with the Administrative Code, are bringing to administrative account which is not release from caused damages.

30.3. In case of activity on creation, testing, production, use, realization and import of living modified organisms and/or derivative products that lead to damage to human health and environment, User and/or Importer, depending on circumstances, are liable in accordance with the legislation of the Kyrgyz Republic.

Natural and legal entities determined as guilty are responsible for damage reimbursement and expenses on liquidation of emergency situations (accidents) and consequences of incidental release to the environment of living modified in accordance with legislation of the Kyrgyz Republic.

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are determined by Expert Commission, appointed by the Intersectoral Coordination Council (Commission) from representatives of Special Competent Administrative Bodies, health care, inspectorate services and the general public.

Liability on reimbursement of damages caused, determined by expert Commission, as well as criminal and administrative liability are established by the Court. In case of damages due to illegal import/export operations with living modified organisms and derivative products thereof, regulations provided for in international legal acts on transboundary movement are implied.

30.5. Guilty in disclosure of confidential information regardless of official position are liable in accordance with the legislation in the field of intellectual property.

CHAPTER 11. Disputes in the sphere of biosafety and international cooperation

Article 31. Order for disputes settlements on biosafety matters 31.1. All deals performed with regard to living modified organisms and derivative products thereof, in

circumvention of the legislation in the field of biosafety are null and void. 31.2. Domestic disputes on granting the rights on use and order for handling of living modified

organisms are considered at the Court or Arbitration Court, in accordance with order established in the legislation of the Kyrgyz Republic

31.3. International disputes are considered on the basis of conciliation procedure. In case of disagreement of Parties, means for disputes settlements except negotiations could be solved through Arbitration hearings or International Court.

Article 32. Implementation of international obligations and international cooperation 32.1. Implementation of international obligations on reports in the sphere of biosafety is charged on

Intersectoral Coordination Council (Commission), which is in time period determined by international agreements communicate all the necessary information to Clearing House Mechanism on Biosafety, submit periodical reports adopted for the purpose of implementation of Cartagena Protocol on Biosafety on Conferences of Parties.

32.2. Universally recognized principles and norms of international law and international agreements of the Kyrgyz Republic in the field of biosafety are the basic part of the legislation of the Kyrgyz Republic.

International agreements of the Kyrgyz Republic are directly applicable to all relations in the sphere of biosafety. If international agreement that bound Kyrgyz Republic provides for other provisions then provided for in the present law, rules and norms of international agreement are applicable, except those cases where more exacting requirements are provided for by the legislation of the Kyrgyz Republic.

CHAPTER 12. Transitional and final provisions

Article 33. Transitional provisions 33.1. From the date of publication of the present law the government of the Kyrgyz Republic during

six month period adopts Degrees on the following matters: a) approve regulations on intersectoral Coordination Council (Commission) and appoint its

composition, including organizational and technical structures; b) adopt Regulation on Biosafety Regime in the Kyrgyz Republic.

33.2. During 6 month period from the publication of the present law all state bodies of executive power are obliged to conduct revision of normative documents relevant to biosafety and handling of living modified organisms, in order to prepare draft legal acts for submission to the Parliament

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of the Kyrgyz Republic for inclusion of additional regulatory norms into the complex of existing laws and legal acts on regulation and control over the turnover of transgenetic organisms.

33.3. All normative legal acts before their compliance with present law are applicable in parts, which are not contrary to the present law.

Article 34. Order for the implementation of the present law. The present law enters into force upon expiry of six month period from the date of its official publication.

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Annex III

Intergovernmental Committee on Cartagena Protocol Recommendation 3/5, the Annex III «the Manual on implementation and introduction of

Cartagena Protocol provisions»

№ Obligations of the country Articles of

Cartagena Protocol

Article of the

draft law

Reflection in the

regulations on Biosafety

Regime

1. Administrative duties 1 To appoint one National Body responsible for

communications with secretariat and send to the secretariat its name and address

19(1),(2) 7,32

2 To appoint one or several bodies responsible for the execution of administrative functions on Protocol implementation and communicate to secretariat their names/address. In case of appointment of several bodies it is requested to designate types of LMO’s that each competent body is deal with

19(1),(2) 8,32

3 Submit to BCH Mechanism:

- any laws related to this sphere of legislation, norms and principles, including those related to LMO’s ;

- any bilateral, regional and multilateral agreements and contracts

20(3)(a)-(b),

11(5), 14(2)

32 List of legal norms

4 Inform BCH Mechanism on those cases when commencement of import supply has to take place at the moment when Application on movement has sent

13(1)(a) 32 -“-

5 Inform BCH Mechanism on LMO’s importation exempted from PIC procedure

13(1)(b) 32 -“-

6 Inform BCH Mechanism on application of national legal norms with regard to concrete types of importation

14(4) 32 -“-

7 Inform BCH Mechanism on contact details to get information from other states on cases of incidental transboundary movement in accordance with Artisle 17

17(2) 32 -“-

8 Notify the Secretariat in cases of access absence to the BCH Mechanism and submit written copies of decisions sent to BCH Mechanism

(For example 11(1))

32 -“-

9 Inform BCH Mechanism on:

- resume of risks assessment or ecological surveys on LMO’s,prepared in the framework of regulation processes and conducted in accordance with Article 15;

- final decisions concerning importation

20(3)(с)-(e)

33

32 -“-

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and release of LMO’s; and

- reports in accordance with Article 33

10 Submit to the BCH Mechanism information on ceses of illegal transboundary movement

25(3) 32 -“-

11 Monitor the implementation of obligations provided for in the Protocol and submit to the Secretariat reports within agreed time frame

33 32 -“-

12 Inform BCH Mechanism on any changes in information provided

32 -“-

II. Legal requirements and obligations

13 Provide conditions on creation, handling transportation, use, transfer and release of LMO’s in such a way , to decrease risks on biological diversity, taking into account human health

2(2) 4,5,11, 14,15,16, 17, 19,

21.3, 25, 26, 27, 29

Procedures and rules

14 Provide for legal requirements as for the accuracy of the information submitted by domestic exporters for the purposes of notification to any country and domestic companies, apllying for the internal permission on LMO’s that can exported as LMO’s -PFE

8(2), 11(2) 9.6, 18,4 Rules

15 Provide for conditions for any national regulatory bases used instead of PIC procedure be in compliance with Protocol’s provisons

9(3) 10.3, 20.2, 20.3

-“-

16. Provide for conditions to conduct decision making procedure in accordance with Article 15

10(!) 9.7, 11.1 -“-

17 Provide for conditions with regard to decisions taken in accordance with Article 10, risks assessment be conducted in a scientically validated manner

15(1), (2) 12 Procedures and

rules

18 Develop and use the mechanisms, procedures and stratagies for regulation, management and risk control connected to the use, handling and transboundary movement of LMO’s, in accordance with Protocol

16(1) 26.5, 26.6 Procedures and

rules

19 Take any necessary measures to prevent incidental transboundary movement of LMO’s, inluding such measures as risks assessment prior the first release of LMO’s

1693) 25 Procedures and

rules

20 Take any necessary measures, that LMO’s, independently whether they imported or created wihin the country, pass necessary period of tests, that comparible with life cicle and term of production, prior permission granting on their target use

16(4) 11.3 Procedures and

rules

21 Take any necessary measures to inform countries concerned of BCH Mechanism, and if necessary, relevant international organisations,on chages that happened in their jurisdictions that lead or could lead to incidental transboundary movement of LMO’s, capable to negatively impact on sustainable use and biodiversity preservation, taking into account risks on human health

17(1) 26.8 Procedures

22 Take any necessary measures that LMO’s subject 18(1) 27 Procedures

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to transboundary movement, in accordance with Protocol, be handled, packaging and trasported with security norms observance, taking into account relevant international rules and norms

23 Take any necessary measures with regard to submission of the following information in documentation that accompany LMO’s-PFE: clear indication that they can contain LMO’s and does not aimed at direct introduciton into environment;

- contact details to obtain any further information.

18(2)(a) 27.2 Procedures

24 Take any necessary measures with regard to submission of the following information in documentation that accompany LMO’s , aimed at use in closed systems:

- clear indication that they are LMO’s;

- requirements with regard to safe handling, storage, transportation and use;

- contact details to obtain any further information; and

- Personal data (names) and addresses of private persons and organisations to whom this cargo is sent

18(2)(b) 27 Annex to Regulations

25 Take any necessary measures with regard to submission of the following information in documentation that accompany LMO’s used for direct introduction into environment, and any other LMO’s, that are covered by the Protocol:

- clear indication that they are LMO’s

- their origin and ceratin features and/or characteristics;

- any requirements concerning safe handling, storage, transportation and use;

- contact details to otain any further information

- Personal data (names) and addresses of private persons and organisations to whom this cargo is sent

- whether is there any statements made that this movement is taking place in accordance with requirements of the Protocol

18(2)(с) 27 Annex to Regulations

26 To take necessary measures to the protection of confidential information, communicated by the Applicant, taking into account exemptions provided for in Artile 21(6)

21(1)(6) 30.5 The law

27 Provide conditions for consultations with applicants and conduct review of decisions in cases of disputs with regard to status of confidential information

21(2) 28.5 procedure

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28 Provide protection to agreed confidential information and information defined as confidential in case of application withdrawal

21(3), 6(5) 30.5 procedure

29 Provide for conditions where confidential information will not be used for commercial purposes without written agreement of applicant


30 Encourage and assist to public awareness rising and participation, education and in the field of safe transfer, handling and use of GMO’s taking into account risks on human health

23(1)(a) 28.2 procedure

31 Take any necessary measures that arrangements on improvement of public awareness and participation could include access to information on LMO’s defined in accordance with Protocol as permitted for importation.

23(1)(b) 28.1 procedure

32 In accordance with applied national laws make consultations with general public in decision making process in accordance with Protocol with observance of the requirements on secrecy of confidential information


33 Inform the general public on ways to get access to the BCH Mechanism

23(3) 28 Coordination of BCH

Mechanism

34 To take necessary measures for the prevention, if necessary, offenders panishment guilty in transboundary movement that circumvent internal measures on Protocol implementation

25(1) 30.4 legislation

35 Remove LMO’s at own expenses, that become the subject of illegal transboundary movement by way of repatriation or destruction if it is necessary upon request of aggrieved party

25(2) 25.1 The law

III. Procedural requirements: prior informed consent (PIC)

36 Submit confirmation in writing on receipt of application within 90 days with incation of the following information:

- date of application receipt;

- compliance of application to the requirements provided for in Annex V of NBF;

- whether would it be possible for importation to take place with written concent and whether should it be conducted in accordance with domestic legal norms or according to Article 10; or

- would it be possible for importation to take place in 90 days without further written consent.

9(2)(a), 10(2)(b),10(2)(a) 9(2)(с)

10(2)(a), 10(2)(b)

10.2 Terms and procedures

37 Inform the applicant in writing during 270 days from the date of application receipt the following information:

- consent on importation with conditions or without any formality;

10(3)9a)-(d),

10(4)

10 Terms and procedures

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- prohibition of import;

- request to submit additional information in accordance with national legal norms or Article 10;

- on extension for particular time period exceeding 270 days, and

- except of those cases when consent has a unconditional character, on reasons for taking particular decsion, including basis to request additional information or on extension of the established time frame.

38 Inform BCH Mechanism on decisions comunicated to the Alpplicant

10(3) 32.1 Terms and procedures

39 During 90 days to reply on request of Export Party on reconsideration of the decision in accordance with Article 10 in cases circumstances changes or receipt of additional essencial scientific or technical information with indication of reasons of taking particular decision that is subject for reconsideration

12(2),(3) 24 Terms and procedures

IV. Procedural requirements: living modified organisms for direct use as food, feed or for processing

40 When final decision has to be taken with regard to domestic use of LMO’s, that could subject for transboundary movement for direct use as food, feed or for processing, including commercial use, information has to be sent to BCH Mechanism within 15 days on decision taken, including all information contained in Annex VI of NBF

11(1) 32.1 Terms and procedures

41 Except for field trials, submit written copies of the final decision to national Coordination Centre of Parties, that inform the Secretariat in advance on access absence to BCH Mechanism.

11(1) 32.1 Norms of implementatio

n

42 Submit information (contact details) with regard to decsion taken on release to the market to any of Parties, which is turn with such a request

11(3) 32.1 Norms of implementatio

n

43 In response to the other Party on decision taken the Party could take a decision on importation to take place with regard to LMO’s used as food feed or for processing:

- or in accordance with national legal norms or Protocol’s provisions;

- in absence of normative legal basis on the basis of risks assessment during time period not exceeding 270 days. In this case it is necessary to send Notification to BCH mechanism

11(4), (6) 22, 23 Terms and procedures

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Annex IV

THE BASIC REQUIREMENTS ON PROCEDURE OF EXPERT RISKS ASSESSMENT

According to article 15 of Cartagena Protocol on Biosafety and Article 12 of draft law of the Kyrgyz Republic «On Biological Safety»

The purpose

1. The purpose of conducting risks assessment procedure according to the Protocol consists in revealing and assessment of potential negative impacts of living modified organisms on preservation and sustainable use of biological diversity in the potentially accepting environment, taking into account risks on human health.

Use of risks assessment

2. Results of risk assessment are used, in particular, by competent bodies for acceptance of the proved decisions with regard to living modified organisms.

Main principles

3. Risk assessment should be carried out in scientifically proved and transparent manner, and expert recommendations and guiding principles developed by relevant international organizations could be taken into account.

4. Absence of scientific knowledge or scientific consensus should not be interpreted necessarily as the indication of certain risk level presence, absence of risk or its acceptability.

5. The risks connected to living modified organisms or products containing them, i.e. the processed materials occuring from LMO and containing new combinations that are capable for detection of the reproduced genetic material which are received as a result of use of modern biotechnology, should be examined in a context of the risks caused by unmodified recipients or parental organisms in the probable potential accepting environment.

6. Risks assessment should be carried out on an individual basis. The required information could vary depending the character and a level of detailed elaboration in each concrete case with regard to relevant living modified organsim, its prospective use and the probable potential accepting environment.

Methods

7. On one hand, risks assessment, probably could require additional information on concrete matters which can be revealed and requested during risks assessment process, on the other hand - in some cases the information on the certain aspects can appear irrelevant.

8. For achievement of an objectives, risks assessment procedure should include, if necessary, the following stages:

а) Revealing of any new genotypic and phenotypic characteristics connected with living modified organism which could negatively impact biological diversity of the probable potentially accepting environment, taking into account risks on human health;

б) Assessment of probability degree of actual occurrence of such negative consequences, taking into account intensity and character of influence of living modified organism on the probable potential accepting environment;

c) Assessment of consequences in the event that such negeative impact will be valid to take place;

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d) Assessment of the overall risk caused by living modified organism, on the basis of consequences probability of the revealed negative impact;

e) Making recommendations on whether risks are acceptable or regulative, including if it is necessary, definition of the strategy for regulation of such risks; and

е) When there is no clarity with regard to risk level, the situation can be resolved by inquiry of the additional information on concrete matters or due to implementation of relevant strategy of risks regulation and/or monitoring of living modified organism in the accepting environment.

Matters to be taken into account

9. Depending on circumstances, during the risks assessment procedure the detailed scientific and technical data concerning characteristic elements on the following aspects are taken into account:

а) The organism - recipient or parental organisms. Biological characteristics of the organism - recipient or parental organisms, including the information on taxonomic status, standard name, origin, centers of origin and the centers of genetic diversity, if it is known, the description of places of dwelling in which organisms can have conditions for survival or fast duplication;

б) The organism - donor or organisms - donors. Taxonomic status and standard name, source and relevant biological characteristics of organisms - donors;

c) Vector. Characteristics of the vector, including its identification data if those are available, its source of origin and circle of its hosts;

d) Insertion or insertions and/or modifications characteristics. Genetic characteristics of introduced nucleinic acid and its defined function and/or characteristics of introduced modification;

е) Living modified organism. Identification data of living modified organism and distinction between biological characteristics of the living modified organism and characteristics of the organism - recipient or parental organisms;

f) Detection and identification of the living modified organism. Proposed detection and identification methods and their accuracy, sensitivity and reliability;

g) Information concerning a prospective kind of use. The information concerning a prospective kind of use of the living modified organism, including new or changed type of use in comparison with the organism - recipient or parental organisms; and

h) Accepting party. Information on location, geographical, climatic and ecological characteristics, including relevant information on biological diversity in the centers of origin in the most probable potential accepting environment.

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Annex V

Information for the Application, required according to articles 8,10 and 13 of Cartagena Protocol on Biosafety and Article 9 of the draft law «On biological safety» (for prior informed

consent procedure)

а) Name, address and contact details of the importer or Producer.

б) Name, address and contact details of the exporter or transgenetic organism’s creator.

c) Name, identification data and national classification of the safety level of living modified organism in the country of export, if available.

d) Prospective date or dates of transboundary movement realization, if those are known.

e) Taxonomic status, standard name, point of collection or acquisition, as well as characteristic of the organism - recipient or parental organisms, relevant to biosafety.

f) Centers of origin and centers of genetic diversity if those are known, the organism - recipient and-or parental organisms and description of biotopes in which organisms can have conditions for a survival or fast duplication.

g) Taxonomic status, standard name, point of collection or acquisition, as well as characteristic of the organism - donor or the organisms - donors, relevant to biosafety.

h) Description of the nucleinic acid or introduced modification, used method, as well as received characteristics of living modified organism.

i) Quantity or volume of the living modified organism subject to transfer.

j) Regulatory status of the living modified organism within the territory of the state export (for example, whether it is for bidden in the state of export; whether there are other restrictions; or whether permission to its general release is given), in case of prohibition of the living modified organism in the state of export, statement of reason or reasons underlying such interdiction.

k) Result of any application sent by the exporter to other governments concerning living modified organism, subject to transfer, and the purpose of sending such application.

Appendix: 1. Approved specificity of the living modified organism application and its prospective use or

characteristic of derivative products, as well as copy of the certificate of the Register on living modified organisms of the country - exporter.

2. Previous or existing report on researches, tests and risks assessment before release to the market with description of adverse effects of genetic manipulations, and also if necessary reports and risks assessment of expert groups or complex expert commissions made as a result of field trials.

3. Conditions for the implementation of measures aimed at preventionof potential risks and suggested methods of maintenance of safe processing, storage, transportation and use, including procedures of destruction and recycling of waste products.

4. Project of measures acceptance, if necessary, in case of emergencies occurrence.

Notice from the applicant for confirmation of actual reliability of the information submitted.

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Annex VI

Information of the Notice required concerning the use in closed systems and import of living modified organisms, intended for direct use as the foods, feed or for processing at local

enterprises, according to Article 11 Cartagena Protocol and Article 9 of the draft law «On Biological Safety»

а) Name and contact details of entity, submitting the application for internal use, including imported LMO’s/GMO’s.

б) Name and contact details of Competent body of country of export responsible for decision-making on release to the market and turnover of created in country transgenetic organisms.

c) Name and identification data of the living modified organism.

d) Description of genetic modification, applied method and characteristics of the living modified organism received as a result of it.

e) Any exclusive identification data of the living modified organism.

f) Taxonomic status, standard name, point of collection or acquisition, as well as characteristic of the organism-recipient and basic differences from the parental organisms, relevant to biosafety.

g) Centers of origin and centers of genetic diversity if those are known, the organism-recipient and/or parental organisms and description biotopes in which organisms can have conditions for survival or fast duplication.

h) Taxonomic status, standard name, point of collection or acquisition, as well as characteristic of the organism-donor or organisms-donors, relevant to biosafety.

Appendix: 1. Approved specificity of the living modified organism application and its prospective use or

characteristic of derivative products, as well as copy of the certificate of the Register on living modified organisms of the country - exporter.

2. Previous or existing report on researches, tests and risks assessment before release to the market with description of adverse effects of genetic manipulations, and also if necessary reports and risks assessment of expert groups or complex expert commissions made as a result of field trials.

3. Conditions for the implementation of measures aimed at preventionof potential risks and suggested methods of maintenance of safe processing, storage, transportation and use, including procedures of destruction and recycling of waste products.

4. Project of measures acceptance, if necessary, in case of emergencies occurrence.

Notice from the applicant for confirmation of actual reliability of the information submitted.

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