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Genetically Modified Organisms Act Of Circulation

Original Language Title: Ģenētiski modificēto organismu aprites likums

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The Saeima has adopted and the President promulgated the following laws: genetically modified organisms Act, chapter I of the General provisions of article 1. The terms used in the law, the law is applied in the following terms: 1)-genetically modified organism any living organism with a new combination of genetic material obtained through legal methods of genetic modification;
2) the techniques of genetic modification: (a) the nucleic acid recombination methods) – new combinations of genetic material, outside the body by various means entering the nucleic acid fragments virus, bacterial plasmid or other vektorsistēm, as well as the transfer of nucleic acids into cells that they formed naturally, but able to continue growth, b) methods associated with the created outside the organism of heritable material in the body, including the introduction of direct, mikroinkapsulācij, c) cell and protoplast merge or hybridisation techniques-creating cells with new combinations of genetic material When you merge two or more cells remote from the systematic organism groups and using techniques that do not occur naturally;
3) movements of genetically modified organisms — activities relating to genetically modified organisms for limited use and release into the environment or market;
4) genetically modified organisms in contained use, any action taken in connection with genetically modified organisms that are controlled using special containment measures that effectively restrict the interfaces with the environment and the effects on it;
5) genetically modified organisms into the environment, genetically modified organisms into the environment tests associated with their further use in agriculture or other sectors of the economy, or any other specific purpose, without using the specific containment measures to limit the genetically modified organisms for direct contact with the environment, as well as the product and the use of veterinary medicinal products in clinical trials, which contain genetically modified organisms, composed or derived from them;
6) genetically modified organisms – the market of genetically modified organisms in products or transfer to third parties in return for payment or free of charge. Distribution of the market include activities related to: (a)) the food containing genetically modified organisms, or the composition is derived from them, b) animal feed containing genetically modified organisms, or the composition is derived from them, c) genetically modified crops seed and plant propagating material movement, d) genetically modified crops, e) genetically modified animal movement, f) genetically modified organisms in other economic sectors;
7) – the coexistence of genetically modified crops, harvesting, storage, preparation, packaging and transportation in addition to organic and conventional farming.
8) risk assessment – on scientific evidence-based measures to identify and determine the potential for genetically modified organisms harmful direct and indirect, short term or long term effects on human and animal health or the environment, 9) emergency-case related to genetically modified organisms accidental escapes out of control during their limited use, when this escape in the short term or in the long term can cause hazard to human and animal health or the environment.
2. article. The purpose of the law the law aims to ensure safe genetically modified organisms, preventing movement of the negative effects on human and animal health or the environment, preserving biodiversity, promoting sustainable agriculture and the development of biotechnology, including genetically modified crops alongside organic existence and conventional farming.
3. article. Genetically modified organisms the principle of decisions related to genetically modified organisms, adopt, subject to the following principles: 1) risk assessment the principle that risk is assessed before the activities related to the movement of genetically modified organisms;
2) the principle of sustainable development, which requires the movement of genetically modified organisms may be permitted if the activity focuses on the development of the national economy and the protection of the environment are complied with laws and regulatory requirements established for sustainable development and the basic principles for the conservation of biological diversity;
3) the precautionary principle, which requires appropriate provisional risk management measures to reduce the danger to risk assessment and risk management for development, if the risk assessment process, there is uncertainty related to the possible adverse effects on human and animal health or the environment, genetically modified organisms spreading environment or market;
4) public awareness and participation the principle that institutions promote public education and awareness, listen and assess public opinion on matters related to the movement of genetically modified organisms;
5) monitoring and control measures on the principle that the proliferation of genetically modified organisms into the environment or the market is allowed only if the genetically modified organism is a detection method and traceability.
4. article. The scope of the law (1) of the Act establishes the competence of the public authorities, physical and legal person (hereinafter person) rights and obligations, genetically modified organisms, including genetically modified crops, principles of coexistence, monitoring and control, community involvement, personal responsibility and legal protection, as well as the security measures and the circulation of information in the event of any possible emergency response.
(2) of the Act do not apply to: 1) gene therapy use in medicine;
2) of the medicinal products and the distribution of the veterinary medicinal product on the market that contain genetically modified organisms, consisting of or derived from them, except in the risk assessment in accordance with the legislation on genetically modified organisms in the environment or market monitoring and authorisation procedures, as well as on the procedure for providing information on the movement of genetically modified organisms and public involvement in the decision-making process;
3) the genetic modification of organisms that occur by using one of the following methods (without using this law, article 1, paragraph 2 of these methods): a) mutaģenēz, (b) the prokaryotic cells species) or protoplast fusion, after which the exchange of genetic material, c) various species of eukaryotic cell or protoplast fusion including hybridoma cells and plant cell hybrid, d) pašklonēšan that the resulting organisms are not dangerous to humans, animals or plants and may not cause the disease nucleic acid isolation – of the following organisms cells, after which follow or not follow all relevant nucleic acid, or its synthetic equivalent, enzymatic or mechanical processing to cause modification of the genetic material and genetic material of the same species enter or filoģenētisk near the related species of organism cells with which the genetic information exchange is also possible natural physiological conditions;
4) genetically modified organisms in contained use, associated with the use of genetically modified organisms which meet the safety criteria laid down in the legislation on genetically modified organisms in contained use and authorisation procedures.
Chapter II the competence of Authorities article 5. Competence of the Cabinet of Ministers (1) cabinet: 1) defines the genetically modified organisms for contained use and authorisation procedures;
2) determines the order in which genetically modified organisms released into the environment or market monitoring and authorisation procedures, as well as the arrangements for providing information on the movement of genetically modified organisms and public involvement in the decision-making process;
3) determines the genetically modified organisms for the risk assessment methodology;
4) lays down the requirements for the coexistence of genetically modified crops, as well as monitoring, control and authorisation procedures;
5) determines to what extent the State fee payable for the genetically modified organisms for the risk assessment findings, as well as its modalities of payment;
6) approve the genetically modified organisms regulations of the Supervisory Board.
(2) the Cabinet of Ministers no less than once every seven years the national biological safety approved system development strategy guidelines and the system development plan.
(3) the Cabinet of Ministers may establish a genetically modified crops growing restrictions in specific areas in accordance with the scientific basis of genetically modified crops can cause substantial losses to the economy or to impede its development, harm human and animal health or the environment.
6. article. The competence of the Ministry of agriculture

Ministry of agriculture, in cooperation with scientific institutions, societies and foundations, developed and jointly with the national authorities responsible for the movement of genetically modified organisms the checks and the monitoring of, implementing the policy in the following areas: 1) the movement of genetically modified organisms;
2) coexistence;
3) national biological safety system development.
7. article. State plant protection service competence the national plant protection services: 1) organized and managed by the national information system – genetically modified crops breeder record-creation and operation;
2) examine applications and takes decisions on genetically modified crops growers into genetically modified crops growers ' register;
3) genetically modified crops provides coexistence during surveillance and control;
4) provides the genetically modified crop varieties of seed and plant propagating material for the supervision and control of movement;
5) genetically modified organisms in seed and plant propagating material;
6) participates in international inter-laboratory testing Roadshow programs;
7) introduces the internationally recognised methods related to genetically modified organisms in seed and determination of plant propagating material;
8) provides detection for genetically modified organisms in seed and plant propagating material in foreign laboratories, where it is not possible to perform in Latvia.
8. article. The food and veterinary service competence the food and veterinary service: 1) on the basis of the scientific opinion of the Commission of experts and genetically modified organisms, the proposal of the Supervisory Board shall issue, as well as revoke the authorisation of genetically modified organisms: (a) restrict the use of, (b))) for distribution to the media, except permission to medicine and the use of veterinary medicinal products in clinical trials, which contain genetically modified organisms, composed or derived from them, c) market penetration except for the permission of the European Parliament and of the Council of 22 September 2003 Regulation (EC) No 1829/2003 on genetically modified food and feed (hereinafter referred to as the European Parliament and Council Regulation No 1829/2003);
2) ensure that the European food safety authority, the European Medicines Agency and the other Member States of the European Union to be the competent institution prepare opinions on evaluation of risk due to the proliferation of genetically modified organisms into the environment or the market would be dealt with according to the European Parliament and Council Regulation No 1829/2003 of the European Parliament and of the Council of 31 March 2004, Regulation (EC) No 726/2004 laying down the procedures for the authorisation and supervision of medicinal products for human and veterinary use Community procedures and establishing a European Medicines Agency;
3) organizes and runs the national information system-genetically modified organism-the life to the establishment and operation of the registry.
9. article. The food and veterinary service of the National Center of competence in the diagnosis of food and veterinary service national diagnostic Center: 1) performs the function of a reference laboratory for genetically modified organisms;
2) participates in international inter-laboratory testing Roadshow programs;
3) introduces internationally recognized genetically modified organism detection methods;
4) provide samples of the genetically modified organisms to foreign laboratories investigation, if it is not possible to perform in Latvia.
10. article. The State Agency of medicines of competence medicine State Agency shall evaluate medicinal products and veterinary medicinal products containing genetically modified organisms, consisting of, or produced from them shall be issued permission to release into the environment, as well as monitor their release into the environment, if the medicinal product is used in clinical trials under the pharmaceutical regulatory law of the procedures laid down.
11. article. Latvian environment, geology and Meteorology Agency's competence in the Latvian environment, geology and Meteorology Agency after submissions from the person that distributes the environment or the market of genetically modified organisms, preparing the monitoring program. Based on the results of the monitoring carried out, persons who distribute or market genetically modified organisms shall inform the Ministry of agriculture on risk assessment and environmental protection measures, which are to be implemented by carrying out activities with genetically modified organisms and disseminating them to the environment.
12. article. National environmental service competence the national environmental services control the environmental conditions for the proliferation of genetically modified organisms into the environment.
13. article. Nature protection management competence of nature protection board shall prepare and submit to the environmental monitoring of the national Office of recommendations, which should be included in terms of the impact on European interest protected natural areas (Natura 2000) the assessment according to the legislation of the environmental impact of the procedures laid down.
14. article. The National Labour Inspectorate's responsibilities the State Labour Inspectorate under the laws and regulations on the protection of health in contact with organic substances, ensure safety and labour protection supervision and control measures related to genetically modified organisms for limited use.
15. article. A scientific expert panel of scientific experts (1) the Commission is a consultative expert working group to review the risk assessment submitted by the parties, as well as prepared and submitted to the food and veterinary service of the scientific opinions on genetically modified organisms for the risk assessment. Scientific experts the Commission shall prepare proposals for the food and Veterinary Office in matters related to the national biological safety system development strategies, and encourage public participation in decision-making on genetically modified organisms.
(2) Scientific Expert Commission preparing the first part of that opinion, assess and take account of this law article 14, the competent authorities referred to in the recommendations.
(3) a food and veterinary service under the national budget provides the scientific expert Commission.
16. article. Genetically modified organisms (1) the Supervisory Board of genetically modified organisms, the Board of supervisors has created a Cabinet advisory body, which coordinates the national biological safety system policy. Monitoring genetically modified organisms Council promotes cooperation between the institutions that control and monitor the movement of genetically modified organisms, and the scientific institutions that conduct research in the field, as well as to facilitate the movement of genetically modified organisms related to the implementation of the national policy cooperation of the participating institutions and national policy development.
(2) monitoring genetically modified organisms shall submit proposals to the Council of the food and veterinary service of this law, article 8, paragraph 1, of the permit.
(3) the genetically modified organisms regulations and Supervisory Board approved the composition of the Cabinet of Ministers. Regulations of genetically modified organisms determines the institutional composition of the Supervisory Board, rights, functions and rules of procedure.
(4) monitoring genetically modified organisms Council Secretariat of the Ministry of agriculture carried out the State budget for the current year for this purpose within the framework of the financial resources.
Chapter III genetically modified organisms in contained use article 17. Genetically modified organisms with limited use of activities related to genetically modified organisms in the limited use of related transactions may be carried out with scientific institutions, registered in the register of scientific institutions (hereinafter referred to as the scientific authority).
18. article. The use of genetically modified organisms the degree of restriction (1) each with genetically modified organisms, the limited use of related activities according to the legislation on genetically modified organisms for contained use and authorisation procedures are established limits, based on a risk assessment, as well as regulations on the protection of health in contact with organic substances.
(2) the genetically modified organisms for limited use of related transactions classified in four classes of security: 1) first class security meet in an activity or risk the risk is negligible. They are activities that meet the first limit set to protect human health or the environment; 2) second security class correspond to activities that pose little risk. They are activities that correspond to the secondary limit set to protect human health or the environment; 3) the third security class correspond to activities that pose a moderate risk. They are activities that meet the third degree limit set to protect human health or the environment; 4) fourth security class correspond to activities that pose a high risk. They are activities that comply with the restrictions of the fourth grade, determined to protect human health or the environment. (3) the security measures shall be carried out according to a given degree of limitation according to the laws and regulations on genetically modified organisms in contained use and authorisation procedures and regulations on the protection of health in contact with organic substances.

19. article. Rights and obligations when performing with the genetically modified organisms for limited use of related transactions (1) genetically modified organisms can start a limited use, if in accordance with the laws and regulations on genetically modified organisms in contained use and the procedure for the issue of the following conditions are met: 1) scientific authority provided them with equipment and installations;
2) made in genetically modified organism risk assessment and determine the degree of limitation;
3) for activities in a statement provided to the food and veterinary service.
(2) for the purpose of the third and fourth class of security according to the genetically modified organism limited use of related transactions, you need to get the food and veterinary service authorized in accordance with the legislation on genetically modified organisms for contained use and authorisation procedures. Without a permit may be made with genetically modified organisms, the limited use of related transactions that meet the first and second class of security, if compliance with the first paragraph of this article.
(3) the scientific authority for genetically modified organisms with limited use of accompanying activities, have the following responsibilities: 1) evaluate the performance of control and security measures in accordance with laws and regulations on genetically modified organisms in contained use and authorisation procedures;
2) to immediately take appropriate control and security measures when there is reason to believe that these genetically modified organisms can no longer meet current scientific knowledge;
3) ensure genetically modified organisms limited the use of occupational safety and hygiene according to the laws and regulations on the protection of health in contact with biological substances;
4) disconnect operation on genetically modified organisms, if, in the light of developments in scientific knowledge, there is reason to believe that it poses a threat to human and animal health or the environment, and inform the competent authorities concerned and the public.
Chapter IV dissemination of genetically modified organisms into the environment or market article 20. The right to distribute genetically modified organisms to the environment or market (1) rights to distribute genetically modified organisms in the environment is the responsibility of the person who received the food and veterinary service or Government agency authorization in accordance with the laws and regulations on the procedures for genetically modified organisms released into the environment or market monitoring and authorisation procedures, as well as the arrangements for providing information on the movement of genetically modified organisms and public involvement in the decision-making process.
(2) the right to distribute genetically modified organisms on the market is the person who receives the food and veterinary service of the authorization in accordance with the laws and regulations on the procedures for genetically modified organisms released into the environment or market monitoring and authorisation procedures, as well as the arrangements for providing information on the movement of genetically modified organisms and public involvement in the decision-making process, or European Parliament and Council Regulation No 1829/2003 lays down the permissions.
(3) the right to grow in the European Union approved genetically modified crops is a person who registered genetically modified crops growers ' register in accordance with the laws and regulations on coexistence between genetically modified crops, as well as the provision of monitoring, control and authorisation procedures.
21. article. Authorisation of medicinal products for clinical trials and veterinary medicinal products containing genetically modified organisms, composed or derived from them, they are permitted to distribute environment, if you have received permission of the national agency of medicinal products and the opinion of the Ethics Committee in accordance with the legislation on medicines and clinical trial observation and the use of food and veterinary service's opinion on genetically modified organisms for the risk assessment in accordance with the laws and regulations on the procedures for in which genetically modified organisms released into the environment or market monitoring and authorisation procedures, as well as the arrangements for providing information on the movement of genetically modified organisms and public involvement in the decision-making process.
22. article. Genetically modified crops-growing restrictions on genetically modified crops may be prohibited in certain areas, which, in accordance with the scientific basis of genetically modified crops can cause substantial losses to the economy and hinder its development, harm human and animal health or the environment. For the said prohibition is informed by the European Commission.
23. article. The use of antibiotic resistant genes, forbidden to distribute or market environment, genetically modified organisms, which contain genes that encode resistance to be used in human or veterinary antibiotics and for which the risk assessment process has been established that there is no adverse effect on human and animal health or the environment. Article 24. The duties of the person the Person who obtained the authorization to distribute or market environment of genetically modified organisms, has the following responsibilities: 1) to comply with the conditions of the authorisation of genetically modified organisms into the environment or market;
2) to ensure the monitoring of the implementation of the measures and informing the competent authority of the results in accordance with the laws and regulations on the procedures for genetically modified organisms released into the environment or market monitoring and authorisation procedures, as well as the arrangements for providing information on the movement of genetically modified organisms and public involvement in the decision-making process;
3) to take appropriate measures and to stop the proliferation of genetically modified organisms into the environment or the market and inform the competent authorities concerned and the public, if new information has become available and there is reason to believe that there is a risk to human and animal health or the environment.
25. article. To ensure the monitoring of the provision of article 24 of this law referred to in paragraph 2, the implementation of the monitoring, the person has the right to negotiate with the competent body on environmental monitoring of this law, article 24, paragraph 2, where the monitoring to ensure the necessary funding for its implementation.
26. article. Its food and animal feed distribution market, containing genetically modified organisms, or composition is derived from them The food and animal feed distribution market, containing genetically modified organisms, or the composition is derived from them, shall be in accordance with European Parliament and Council Regulation No 1829/2003 and Council of 22 September 2003 Regulation (EC) no 1830/2003 concerning the traceability of genetically modified organisms and marking as well as produced from genetically modified organisms in food and feed traceability of the amending Directive 2001/18/EC.
Chapter v access to information and public participation article 27. Access to information and transparency public competent authorities provide information on the movement of genetically modified organisms in accordance with the movement of genetically modified organisms in the regulatory laws and requirements.
28. article. Public participation in the decision-making process (1) – every individual, as well as associations and foundations have the right to submit proposals or to express their views before the competent authority shall issue the authorisation of genetically modified organisms for limited use, release into the environment or the market.
(2) the arrangements for the participation of the public and organize public consultation related to the movement of genetically modified organisms, specific laws and regulations on the procedures for genetically modified organisms released into the environment or market monitoring and authorisation procedures, as well as the arrangements for providing information on the movement of genetically modified organisms and public involvement in the decision-making process.
(3) the competent institution shall involve the public in the decision-making process, before a decision is taken on genetically modified organisms in contained use, release into the environment or the market.
29. article. Authorities, associations and Foundation features local authorities, associations and foundations may submit proposals to the Ministry of Agriculture to the specific area to be declared free of genetically modified crops, where, in accordance with the scientific basis of genetically modified crops can cause substantial losses to the economy of the territory or to impede its development, harm human and animal health or the environment.
30. article. Obligation to provide information (1) the Person conducting activities with genetically modified organisms, codified and stored information related to the movement of genetically modified organisms, and presented it at the request of the competent institution.

(2) a Person who carries out activities with genetically modified organisms, immediately under the laws and regulations on the movement of genetically modified organisms shall inform the relevant competent authorities and the public of when received sound scientific opinions on genetically modified organisms for possible adverse effects on human and animal health or the environment. Article 31. The circulation of information the competent authorities shall ensure that the persons, the Member States of the European Union, the European Commission, the European food safety authority, European Medicines Agency and other bodies occur in the exchange of information on the movement of genetically modified organisms.
Chapter VI Supervision and control article 32. The supervisory and control body movement of genetically modified organisms in regulating the enforcement of laws according to competence, monitor and control food and veterinary service, national environmental service, national plant protection service, the State Labour Inspectorate and the State Agency of medicines.
33. article. Supervisory and control authorities the right to (1) surveillance and control bodies have the right to: 1 Inspector) take control of and access to documents, in order to ensure the fulfilment of the conditions laid down in the authorisation;
2) take samples to determine whether in human food, animal feed, seed and plant propagating material, as well as other environmental objects is genetically modified organisms;
3) event of a threat to human and animal health or the environment, according to the competency set limits or prohibitions.
(2) in the event of a threat to human and animal health or the environment, the right to set limits or prohibitions on genetically modified organisms in circulation are: 1) the food and veterinary service Director-General – genetically modified organisms on the market;
2) national labour inspectorate Director-the genetically modified organisms for limited use;
3) national environmental services Director-General – genetically modified organisms into the environment.
(3) national plant protection services shall have the right to: 1) cancel the registration of genetically modified crop growers in the register, if there is a breach of the conditions of the laws on genetically modified crops and coexistence;
2) to ban genetically modified crops, if new information has become available for their negative impact on human and animal health, the environment or biodiversity.
34. article. Action in emergency situations (1) of the food and veterinary service Director General, establish and approve the plan of action, responsible for emergency action in emergencies, civil protection, and comply with regulatory legislation and genetically modified organisms within the regulatory laws and requirements.
(2) in exceptional cases, the food and veterinary service Director-General: 1) supports and coordinates the implementation of emergency plans;
2) ensure circulation of information in accordance with the laws and regulations on food and genetically modified organisms in circulation;
3) carried out an emergency analysis and in accordance with the laws and regulations on the movement of genetically modified organisms to prepare proposals for the avoidance of similar cases.
Chapter VII liability and redress article 35. Responsibility (1) persons who breach of genetically modified organisms within the regulatory normative acts, called for laws to determine responsibility.
(2) the prosecution shall not be exempt under the first paragraph of this article of the person from the obligation to pay damage to human and animal health and the environment.
(3) liability for genetically modified organisms in circulation as a result of the damage to human and animal health, as well as for damage or to an imminent threat of environmental damage, determine the environmental protection law and other laws.
36. article. Legal protection of rights in the field of biotechnology and exceptions in relation to biotechnological inventions, as well as the legal protection of the Patent determined by law.
Transitional provisions 1 the Cabinet until December 1, 2008, we issued this law article 5 referred to in the first subparagraph, the provisions of the Cabinet of Ministers.
2. Until the new cabinet from the date of entry into force of the provisions, but not longer than until 1 December 2008, apply to the Cabinet of Ministers of 20 April 2004, Regulation No 333 "rules on genetically modified organisms for contained use and deliberate release into the environment and market, as well as monitoring procedures", to the extent they do not conflict with this Act.
3. This law, article 5, point 5 shall enter into force simultaneously with the corresponding amendments to the law "About taxes and duties".
Informative reference to European Union directives, the law includes provisions resulting from: 1) of the European Parliament and of the Council of 12 March 2001, Directive 2001/18/EC on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC;
2) of the Council of Europe of 26 October 1998, the provisions of Directive 98/81/EC amending Directive 90/219/EEC on the contained use of genetically modified micro-organisms;
3) of the Council of Europe on 23 April 1990 directive 90/219/EEC on the contained use of genetically modified micro-organisms.
The law adopted by the Parliament in the 2007 on November 15.
President Zatlers in Riga, v. 5, 2007 December Editorial Note: the law shall enter into force on 19 December 2007.