Genetically Modified Micro-Organisms, As Well As The Authorization And Cancellation Procedures

Original Language Title: Ģenētiski modificēto mikroorganismu ierobežotas izmantošanas, kā arī atļaujas izsniegšanas un anulēšanas kārtība

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Cabinet of Ministers Regulations No. 784 Riga 2008. on 22 September (pr. No 67 37) genetically modified organisms in contained use and the procedure for issuing a permit Issued in accordance with the movement of genetically modified organisms Act article 5, first paragraph, point 1 1. General questions 1. determines: 1.1. genetically modified organisms in contained use (hereinafter referred to as limited use) notification procedures;
1.2. limited use of the authorisation procedure;
1.3. monitoring and control obligations and rights of the institutions;
1.4. the responsibilities of the scientific institutions, rights and responsibilities;
1.5. restricted use of risk assessment;
1.6. the genetically modified organisms safety criteria;
1.7. General principles for working with genetically modified organisms. 2. the rules shall not apply to: 2.1. activities of the contained use, if genetically modified organisms used to meet this provision, mentioned in Chapter 7 safety criteria and the criteria are published in the official journal of the European Union;
2.2. the genetically modified organisms, which are permitted to distribute or market under legislation on genetically modified organisms into the environment or market distribution, 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;
2.3. food and animal feed, which allowed the market penetration of the European Parliament and of the Council of 22 September 2003 on the application of Regulation (EC) No 1829/2003 on genetically modified food and feed. 2. Limited use of the notification procedure 3. Scientific Authority before the limited use made of food and veterinary service statement: 3.1 for the jobs, which for the first time for contained use;
3.2. for the proposed contained use activities. 4. The communication on the job, which for the first time for contained use, include the following information: 4.1 scientific institutions the name, registration number in the register of scientific institutions and registration, the actual and legal address, phone number, and laboratory space plan;
4.2. monitoring and safeguards of the person responsible, as well as professional qualifications in this field;
4.3. proposed contained use activities description and genetic modification;
4.4. the intended use of the limited activities in security class;
4.5. If the workplace for contained use activities that corresponds to the class of security, in addition to the State: 4.5.1. Summary of risk assessment in accordance with the provisions of Chapter 6;
4.5.2. supervisory and control bodies information on waste and waste management compliance with legislation on waste management. 5. A scientific authority of the contained use activities corresponding to the first class of security under majai this rule 26 requirements referred to in paragraph, starting after it has notified the food and veterinary service of jobs. 6. The notice of the contained use activities commence, the second security class, include the following information: 6.1 the date the Declaration for jobs;
6.2. monitoring and safeguards of the person responsible, as well as professional qualifications in this field;
6.3. proposed contained use activities in the security class;
6.4. information on restrictive and security measures for the limited use of the finance operation according to the annex to these provisions, the passengers of measures to review bežošan recurrence and defining the tivitāt design;
6.5. a copy of the letter showing that the supervisory and control counselling tions are sent the original notice according to the laws and regulations on labor protection requirements when dealing with biological substances;
6.6. proof of waste and waste water management plan, waste and sewage disposal, recycling and registration of compliance with legislation on waste management and to annex these provisions;
6.7. a copy of the authorisation of waste management according to the RUS matīv provisions concerning waste management (where required);
6.8. the type of the recipient, donor organism and, if possible, for the purposes of vector systems;
6.9. the genetic modification of the genetic material and the intended functions of the genetically modified organism;
6.10. the genetically modified organisms and the characteristics of its identity;
6.11. the use of genetically modified organisms in the objectives and expected results;
6.12. the contained use activities in the cell culture;
6.13. Summary of risk assessment in accordance with the provisions of Chapter 6;
6.14. information on action in emergencies, and a list of the owners of the territory, which could be threatened by the limited use of the emergency. 7. Limited use activities that correspond to the second security class, launched for the first time after 45 days from the date of the food and veterinary service of the notification. These steps initiate faster if received the food and veterinary service. 8. the scientific institution after submission of the notification the food and veterinary service of the contained use activities for the second class of security, limited use can start immediately, if the last two years it has already made a statement about the limited use of the activities for the second class of security, or has received permission to use the restricted activities that meet higher security class, and has fulfilled all the requirements laid down in the authorisation. 9. The notice of the contained use activities, corresponding to the third and fourth security class, shall include the following: 9.1. date when the filed statement of work;
9.2. the surveillance and security measures, of the person responsible, as well as professional qualifications in this field;
9.3. the proposed contained use activities in the security class;
9.4. information about restrictive and security measures for the contained use activity according to the annex to these provisions, limited review measures ry periodicity and the efficiency of the inspections plan;
9.5. a copy of the letter showing that the supervisory and control authorities have sent the original notice according to the laws and regulations on labor protection requirements when dealing with biological substances;
9.6. proof of waste and waste water management plan, waste and sewage disposal, recycling and registration of compliance with legislation on waste management and to annex these provisions;
9.7. a copy of the authorisation of waste management according to laws and regulations on waste management;
6.1. information about the recipient, donor organism and for the purposes of vector systems;
9.9. the genetic modification of the genetic material and the intended functions of the genetically modified organism;
9.10. the genetically modified organism characteristics and method of determining its identity;
9.11. using genetically modified organism's objectives and expected results;
9.12. limited time of use in cell culture;
9.13. evaluation of laboratory equipment with limited use of the foreseen activities;
9.14. increasing information about emergency prevention, action plan, and a list of owners of their territory which could be compromised by the use of bežot passengers in case of emergency if: 9.14.1. identified risk related to the location of the machine;
9.14.2. apply special precautions (security devices, alarm systems and containment methods);
9.14.3. appropriate measures to control the efficiency of the procedures of the standing over pleasure and plans;
9.14.4. employees information on the activities of the limited Muggle artifacts;

9. risk assessment a copy of the report in accordance with the provisions of Chapter 6. 10. If the scientific authority withdraws the notification on the limited Muggle artifacts, food and veterinary service shall not disclose the information provided in the notice. 3. Limited use of permit 11. food and veterinary service shall issue the authorisation contained use activities that correspond to the third and fourth class of security, not later than 90 days after receiving this rule 9, paragraph scientific institutions. 12. If the scientific institution during the last two years after the date of notification of the contained use activities that correspond to the third and fourth class of security, has made repeated statements about the limited use activities that meet these safety classes, and have fulfilled the requirements mentioned in the authorisation, the food and veterinary service permission to use a limited operation, corresponding to the third and fourth security class shall be issued no later than 45 days after the receipt of the notification the scientific institutions. 13. additional information or advice needed food and veterinary service does not include this provision 7, 11 and 12 points in the period. 14. Public information on the contained use activities in the food and veterinary service of the permit may be extended for not more than 30 days from the date of notification of the contained use activities. 15. food and veterinary service shall not grant authorisation if: 15.1 the scientific authority has not provided the additional information requested;
15.2. the limited use activities are causing significant damage to human and animal health or the environment;
15.3. the scientific institution or in the summary risk assessment report has deliberately concealed information about the possible risks or harm human and animal health or the environment. 16. food and veterinary service revoke the authorisation if: 16.1 has been made available to the new scientific information that limited use substantial injury to human and animal health or the environment;
16.2. limited use of the specified protection class of the activity and restrictive measures or conditions issued is no longer appropriate to limit exploitation would be safe;
16.3. emergency has occurred, giving rise to significant risks to human and animal health or the environment;
16.4. the scientific institution does not comply with the conditions laid down in the authorisation. 4. Supervisory and control duties and the rights bodies 17. Supervisory and control bodies shall inform the food and veterinary service of the alleged infringements or irregularities in the workplace, where limited use. 18. the food and Veterinary Office has the following responsibilities: 18.1 to grant or revoke permission for use of the restricted activities that match specific security class;
18.2. to determine the intended use of the limited activities such permit conditions that support a particular genetically modified organism in the secure limited use;
18.3. to review and give an opinion on the scientific institution of the genetically modified organism in compliance with the safety criteria;
18.4. the time to report to the European Commission on genetically modified organisms in compliance with the safety criteria;
18.5. to inform the public about the limited use of the reported activities and involve them in restricted-use permitting process;
18.6. Insert movement of genetically modified organisms in the register with the following information: name of the scientific institutions 18.6.1., which announced a limited use or authorised for limited use;
18.6.2. allowed limited use of the security class action;
18.6.3. proceedings of the authorized or limited use in the risk assessment activities of the summary or a copy of the report, except for confidential information;
18.6.4. allowed limited use of performance targets and issued at the validity of the will's;
18.6.5. contingency plan, if such is necessary for the limited use;
18.6.6. list of owners of their territory, which could be threatened by the limited use of the emergency;
18.7. to insert the movement of genetically modified organisms, information on the registry of decisions not later than seven days after the issue of a permit for a specific limited use;
12.8. to evaluate the scientific information provided by the authorities on emergency measures and develop the use of the restricted plan of action in an emergency;
11.7. to agree with scientific institutions on information that the communication be granted restricted availability status. Restricted availability status is not granted such information should 18.9.1. scientific institutions: the name, registration number in the register of scientific institutions and registration, the actual and legal address, phone number;
18.9.2. genetically modified organism characteristics and method of determining it;
18.9.3. restricted use of the operational objectives and expected results;
18.9.4. restricted use of the security class action and restrictive measures;
18.9.5. Summary of risk assessment or risk assessment. 19. Food and veterinary service has the following rights: 19.1. to require from scientific institutions more information if the risk assessment is you have questions or information provided is not sufficient to carry out the risk assessment analysis;
19.2. make changes to scientific institutions in the past week in the containment or other safety measures or change certain Muggle artifacts of a limited class of security;
19.3. to amend the conditions of the authorization granted. 5. the responsibilities of the scientific institutions, rights and responsibilities of the scientific institution of the 20th century has the following responsibilities: 20.1. using the detect restricted transactions in the security class, containment and safety measures based on risk assessment in accordance with the provisions of Chapter 6;
20.2. ensure limited use with restrictive and security measures, taking into account the limits conferred the degree;
20.3. to provide the initial notification to authorities of supervision and control of the limited use activities, corresponding to the second, third or fourth class of security, according to the laws and regulations on labor protection requirements when dealing with biological substances;
20.4. to prepare and submit to the food and Veterinary Office observed the resultant estimates of risk summary or a copy of the report for the proposed limited use;
20.5. to apply general principles to work with genetically modified organisms in accordance with the provisions of Chapter 8;
20.6. working with microbiological preparations to implement proven principles in practice;
20.7. periodically review the restrictive and appropriate security measures and submit a food and Veterinary Office report on compliance with the restrictive measures of the action to be taken: the first security 20.7.1. class-at least every three years;
20.7.2. second class of security − not exceeding two years;
20.7.3. third and fourth class of security-not less than annually;
12.9. to apply more restrictive security measures, and if there is any doubt about the limited use of compliance with specific safety class;
20.9. store with limited use of the related risk assessment summary or a copy of the report and to provide information, if requested by the food and veterinary service;
20.10. to list the use of the limited number of animals and used to inform food and veterinary service;
20.11. to inform the supervisory and control body under the laws and regulations on labor protection requirements when dealing with biological substances and immediately review the restrictive measures, if: 20.11.1. has been made available to the new scientific information on potential harm to humans and animals or the environment;
20.11.2. There is a need to make changes to the notification submitted to the community response to these rules 4, 6 and 9 the requirements referred to in paragraph on contained use activities;
20.11.3. the restrictive and applied security measures no longer answers to the intended use of the limited community, or also the use of the limited actions do not meet the security laid down in the notification class;
20.11.4. There is reason to believe that scientific institutions from the risk assessment does not meet the latest scientific or technical knowledge;
20.12. to inform the supervisory and control body under the laws and regulations on labor protection requirements when dealing with biological substances and food and veterinary service, if an emergency occurred, and provide information about: 20.12.1. emergency conditions;
20.12.2. genetically modified organisms in the identity and quantity of emissions;
20.12.3. genetically modified organism effects to human and animal health or the environment;
20.12.4. measures implemented;
20.13. to terminate the limited use if: 20.13.1. There is reason to believe that the limited use of human and animal health or the environment;

20.13.2. happened emergency. 21. the scientific institution has the following rights: 21.1. request the food and Veterinary Office to issue the permit contained use activities that comply with the second, third and fourth class of security;
21.2. reducing restrictive and security measures, which corresponds to a limit degree if food and veterinary service has specified a lower limit to the degree of compliance with safety;
21.3. request the food and Veterinary Office to examine certain genetically modified organisms in compliance with the safety criteria in accordance with the provisions of Chapter 7. 22. the scientific body is responsible for the limited use of the harm human and animal health or the environment under the legislation on the protection of the environment. 6. restricted use of risk assessment 23. To give the limited use of appropriate security operations class and certain restrictive and security measures, taking into account the degree of restrictions provided for contained use activities and related processes in the institution of a scientific risk assessment carried out in accordance with the provisions of subsection 6.1. and 6.2. 24. the activities of the limited usage, corresponding to the first and second class of security risk assessment summary description of genetically modified organisms and related activities possible damage to human and animal health or the environment. 25. The limited use which corresponds to the first class of security activities, determined by measuring the effects of the genetically modified organism to human and animal health, which is not to weaken the immune system, and plants. 26. the first class of the limited use of security activities comply with genetically modified organisms, if: 26.1. the recipient or the donor organism to cause disease in humans and animals, or damage to the environment and their safety is confirmed through documented scientific publications. To determine compliance with this safety criterion States: 26.1.1. the recipient or the donor organism the ability to cause disease in humans and animals, or plants, taking into account the environmental conditions in which the recipient or the donor's body might be in the future;
26.1.2. avirulent strain of safety to human and animal health or the environment, if the virulent strain is not among the approved strains of acknowledged pathogenic species. Such a strain is stably deficient in genetic material that determines virulence, or has stable mutations;
26.2. the vector and the insert the genetic material does not grant the phenotype of the genetically modified organism, which can cause disease in humans or animals or plants or to cause damage to the environment. To determine compliance with this criterion, determines whether the vector and the insert contains genes that express the protein or transcripts of assets in such quantities and form that can be assigned to the genetically modified organism the phenotype, which cause disease in humans or animals or plants or causing damage to the environment. Be safe be considered genetically modified organism, vector or inserts, which contains sequences responsible for harmful traits expression against certain micro-organisms, but in general the genetically modified organism to cause disease phenotype of humans or animals or plants;
26.3. the genetically modified organisms in which the inserted or removed the genetic material does not cause disease in humans or animals or plants or environmental damage. 27. The limited use activities corresponding to the third and fourth class of security risk assessment report includes analysis in accordance with the provisions of subsection 6.1. and 6.2. 28. Risk assessment of contained use activities carried out in two stages. 6.1. The Risk assessment, the first stage of the first phase of 29 scientific authority determines and describes all the genetic modification of materials involved in the adverse environmental and health properties, as well as their harmful characteristics, due to the genetic modification of the recipient organism. About harmful recognised when involved in the genetic modification of material properties match one of the listed characteristics: 29.1. pathogenic to humans, animals or plants or to cause allergic or toxic effects. The specific allergenic or toxic factors appreciated in relation to human and animal health, which is not impaired immunity;
29.2. the ability to interfere with the operation of preventive or curative nature;
29.3. produces harmful effects to human and animal health or the environment;
29.4. able to spread unchecked in the environment;
29.5. able to move other organisms or integrate their genetic material, the uncontrolled spread of the time;
29.6. is phenotypically and genetically unstable. 30. to determine genetically modified organism from the harmful and potentially harmful effects on human and animal health or the environment, the scientific authority shall evaluate its components that make genetically modified organism: 30.1. recipient organism to indicate the following characteristics: 30.1.1. pathogenicity, virulence, ability to infect, allergenicity, toxicity and the transfer of disease vectors;
30.1.2. vector and random nature of the agent;
30.1.3. areas where vectors and adventitious agents can mobilise the inserted genetic material and the frequency of mobilisation;
30.1.4. attenuating mutation activity types and their permanence, if any;
30.1.5. previous genetic modifications;
30.1.6. donor organism bow;
30.1.7. most significant physiological traits which may be altered in the final of the genetically modified organism, and, where appropriate, their stability;
30.1.8. natural habitat and geographic distribution;
30.1.9. participation in that important environmental processes;
30.1.10. interaction with other organisms in the environment and its consequences;
30.1.11. the ability to form survival structures;
30.2. the donor organism (if the merge experiments or experiments using the skrotēšan method (shotgun), the insert is not well) with the following characteristics: 30.2.1. pathogenicity, virulence, ability to infect, allergenicity, toxicity and the transfer of disease vectors;
30.2.2. use vector addition: the sequence 30.2.2.1.;
30.2.2.2. the frequency of mobilisation and specificity;
30.2.3. the existence of genes which confer resistance to antimicrobial substances, including antibiotics;
30.2.4. circle of donor organism;
30.2.5. other significant physiological traits;
30.3. the insert, the following characteristics: 30.3.1. identity of the insert, and nucleotide sequence of the insert (genes);
30.3.2. the characteristics of the expression of genetic material;
30.3.3. source of the genetic material, the identity of the donor organism and where applicable, personal characteristics;
30.3.4. history of previous genetic modifications;
30.3.5. inserted the genetic material in the location in the genome of the recipient (indicate whether the characteristics material activates/deactivates the genes of the recipient organism);
18.9. vector, giving the following personal characteristics: 30.4.1. a vector type, sequence and origin;
30.4.2. the structure and the expected quantity of the vector and the donor organism remaining nucleic acid sequences end in genetically modified organism's structure;
30.4.3. frequency of mobilisation of the vector and the ability to transfer genetic material, if genetically modified organisms the final disc is inserted in the vector;
30.5. the genetically modified organisms to indicate the following characteristics: 30.5.1. in relation to human health: genetically modified organism 30.5.1.1. and its metabolic products toxic or allergenic effects;
30.5.1.2. the genetically modified organism in pathogenicity as compared to the recipient and the parental organisms;
30.5.1.3. the genetically modified organism colonization;
30.5.2. as regards genetically modified organisms, which is pathogenic to people with weakened immune system: diseases caused by 30.5.2.1. prevalence and virulence mechanisms of transmission;
30.5.2.2. infective dose;
30.5.2.3. potential changes in the way of infection or tissue specificity;
30.5.2.4. survival outside the human body;
30.5.2.5. biological stability;
30.5.2.6. the spectrum of resistance to antibiotics;
30.5.2.7. the allergenicity;
30.5.2.8. toxicity;
30.5.2.9. the applicable therapies and preventive measures;
30.5.3. in relation to the environment: 30.5.3.1. ecosystems in which genetically modified organism can inadvertently spread outside the restricted use;
30.5.3.2. the genetically modified organism viability, reproduction and distribution of the volumes defined ecosystems;
30.5.3.3. the expected result if a genetically modified organism is accidentally leaked outside of the restrictive measures and interact with other organisms;
30.5.3.4. harmful or potential harmful effects to plants or animals;

30.5.3.5. known or alleged membership on biogeochemical processes. 31. to assign the initial security class involved in the modification of the recipient organism, the scientific authority of the recipient organism given rise that group using the classification of biological agents, laid down in laws and regulations concerning labour protection requirements when dealing with biological substances or other internationally recognized classification of micro-organisms. To use certain restricted activities of the original security class, do the following: 19.3. Description of the genetically modified organism and related other materials specified harmful genetic characteristics;
31.2. the significance of the damage and assess all the biological features, which restrict the possibility of harm occurring. The significance of adverse effects be assessed regardless of whether adverse effects are possible. Any possible adverse impact significance is determined by considering what would be the effect, not whether such damage could occur. Genetically modified organisms harmful or adverse impact significance can be valued in relation to human and animal health or the environment; 31.3. indicates the restrictive and security measures corresponding to the contained use activities in the original security class. 32. the assessment of genetically modified organisms in the possible adverse effects of the scientific authority: 32.1. Description of genetically modified organisms in the survival of the environment;
32.2. the description of the genetically modified organism direct harmful effects that may arise from significantly altering the environment physical and chemical properties of the soil or the water ecological balance of ingredients;
32.3. points to the need for additional risk management measures, if specific or genetically modified organisms in the expected adverse effect on human and animal health or the environment to the extent that a specific manifestation of the injury should be reduced to the lowest level;
32.4. points awarded safety class and conformity of the restrictive measures, in the light of the limited use of speciality activities (the actual operations, work practices, and containment measures). 33. In analysing the activities of the limited use of scientific authority: 33.1. review and apply restrictive and security measures, in the light of the limited nature of the use. A particular manifestation of the injury to human and animal health or the environment with restrictive security measures and reduced to the lowest level;
33.2. detailed description of the limited use activities that correspond to the third and fourth class of security, or activities that are not commonplace or routine procedures, such procedures, which could have a serious impact on the degree of risk. 34. In analysing the use of genetically modified organisms, the concentration and volume of scientific institution: 34.1. Description of the limited use of dangerous organisms used in the impact of the merger and the possibility of adverse effects occur in the cultural density of performing activities related to the very concentrated presence of genetically modified organisms;
34.2. a description of the identified potential risks in relation to the use of the organisms, which may be absolute or single operation often repeat the process. 35. Analyzing the microorganisms culturing conditions, scientific authority: 21.8. description contained use activities used container and other equipment safety and risks associated with them;
35.2. Description and technical equipment failure rates. If the equipment has identified deficiencies, provide additional restrictive measures or higher degree of restrictions to the extent of protection for human and animal health or the environment;
35.3. the standard action in cases of limited use of the effects described in General, taking into account the effectiveness of the restrictive measures;
35.4. indicate the appropriate biological and chemical restrictive measures. 36. in the case of genetically modified organisms in environmental impact of scientific authority: 36.1. indicate and describe whether particular environment are organisms which might be exposed to the effects of the genetically modified organism;
36.2. indicate the organisms, which are sensitive to the limited use of influence;
36.3. points to the genetically modified organism, the environmental impact and the way;
36.4. describes the environmental part that is exposed to the effects of the limited use (environmental part that is cut off with restrictive measures). Given that the impact on the environment depends on the type and extent of actions, genetically modified organism indicates a possible leak, causing more of the affected part of the environment. 6.2. The Risk assessment phase two 37. Scientific Authority, in determining the final security class and containment and safety measures: 37.1. indicates the final use of the limited security operation class, having regard to the first stage, certain harmful features of everybody involved genetic materials;
37.2. the definitive description of the restrictive and security measures, taking into account the characteristics of the genetically modified organism in the first stage. 38. Scientific Authority prepare an opinion on the restrictive security measures and compliance with the proposed contained use activities, stating that: 38.1. the risk assessment, the first phase is not sufficiently taken into account the possible adverse effects, therefore the proposed restrictive measures do not restrict a specific manifestation of the injury at the lowest level. In this case apply in addition to the containment and safety measures or set at a higher limit, the need to review the limited use;
38.2. the limited use of the granted security class action is correct, because the applicable control measures are sufficient to limit a specific manifestation of the injury at the lowest level;
38.3. the risk assessment, the first phase granted higher security class, compared with the specific harm, thus limiting the allowed grade or class of security. 7. the genetically modified organisms safety criteria 39. Genetically modified organisms are safe for human and animal health or the environment, if they satisfy the General and specific safety criteria. 40. in compliance with the General and specific safety criteria demonstrate the documentary. 41. The General safety criteria are as follows: 41.1. is determined the identity of the donor organism, using one or more of these methods to prove its authenticity: 41.1.1. morphology;
41.1.2. painting;
41.1.3. electron microscopy;
41.1.4. serology;
41.1.5. metabolic profiles after use or degradation;
41.1.6. isoenzyme analysis;
41.1.7. protein and fatty acid profiles;
41.1.8. guanīn and citozīn of the overall percentage of nucleotides;
41.1.9.-DNA (DNA)/ribonukleīnskāb (hereinafter referred to as the RNA) analysis to a taxon specific DNA and RNA sequences, identification;
41.1.10. gene probes for analysis;
41.2. the detailed structure of the insert and vector new genetically modified organisms, as well as in the vector and the insert indicates the full nucleotide sequence. In order to avoid harmful characteristics, limits the size of the insert and vector so that it contains the minimum required number of genetic elements;
41.3. the details of the recipient, the donor organism and genetic modification history, giving the previously published results and information for the safety assessment of organisms;
25.7. indicated in the scientific evidence on the safety of genetically modified organism after the modifications that the recipient or the donor organism has been harmful or pathogenic traits;
25.8. describe the process of genetic modification of genetic material involved in the taxonomic relationships to identify potentially harmful characteristics, which usually gets, but not genetic modification may take later;
25.8. tested eikariotisk cell and tissue culture identity according to international classifications;
25.9. scientifically sound data on the genetic modification of genetic material used in safety, the taxonomic characteristics, phenotypic and genetic characteristics;
41.8. made and recorded the identity of organisms of analysis referred to in this provision, if a particular 41.1. organism is not sufficiently researched and described in the scientific literature;
41.9. indicated results previously published for the recipient or the donor organism safety in different circumstances;

41.10. the genetically modified organisms the genetic stability. Genetically modified organisms can be considered stable if the genetically modified organism genetically stability is equivalent to the modified organism not stability. Provide a detailed description of the stability of the genetic modification, where, after genetic modification used activity absorbing mutation, to weaken the body's harmful characteristics. If genetically modified organism identified the genetic instability that is not essential to the scientific evidence on the safety of genetically modified organism and the safety of human and animal health or the environment. 42. Specific safety criteria are as follows: 42.1. the genetically modified organism, if the pathogen: an examination of scientific literature 42.1.1. does not have the genetic material of the pathogenic effects on human and animal health or on the plants. If genetically modified organisms can cause harm to people with weakened immune systems, such damage should be considered and should be noted;
42.1.2. is available for a long period of time collect scientific information about the safety of the donor organism being studied for human and animal health or the environment. If no analysis in relation to pathogenicity of the micro-organism, then ensure the recipient and the donor organism. Special consideration to new genetically modified organisms differs significantly from the donor organism;
42.1.3. the specified virus originating in eukaryotic and attrition, as well as the stability of existing features (eukaryotic viral vectors may be used only to create a deletion mutation);
42.1.4. genetic material is available on the stability analysis both before and after the modification. To prove the consistency of a certain strain of safety criteria belonging to pathogenic species and not virulent, specify the following information: 42.1.4.1. scientific data that the strain is virulent and do not cause adverse effects on human and animal health or the environment; 42.1.4.2. the donor organism is stably deficient in genetic material that determines virulence, or has stable mutations that dramatically reduce virulence. Analysis (pathogenicity test, genetic investigation with probes, phage and plasmid, restriction enzyme mapping, sequencing and protein probes), and it is known that the strains are harmless. A new gene transfer, ensure genetic analysis of reverse mutation of the gene deletion or risk;
42.1.5. the genetically modified organism contains the vector and the insert, which is not an active protein or transcript in such quantity, which gives the phenotype the genetically modified organism that could cause human and animal disease or cause adverse effects on the environment;. 42.1.6 process of genetic modification is not used in such a vector or inserts, which sequences in other micro is responsible for the harmful characteristics of the genetically modified organism and assign the phenotype that cause human, animal and plant diseases or cause damage to the environment;
42.1.7. vector is specified by the phenotypic changes in different donor organisms. In this case, pay attention to the ability to assign a vector to the genetically modified organism virulence or other harmful properties;
26.2. the genetically modified organisms are not toxic if: 42.2.1. body by genetic modification does not generate toxic characteristics;
42.2.2. genetically modified organism is analysis and identifies the insert and vector capabilities to transfer or to stimulate (repress) toxin production. Indicates the results of the analysis, which shows the vector and the insert safety for human and animal health or the environment;
26.3. the genetically modified organisms are not allergens if: the genetic modification of organisms 42.3.1. process does not use biological agents that cause allergies according to the laws and regulations on labor protection requirements when dealing with biological substances;
42.3.2. the genetically modified organisms does not contain the genes that might cause significant allergen products;
26.3. the genetically modified organisms does not contain such random agents that can harm human and animal health or the environment. If, following the use of genetic modification of the recipient and the donor strain that does not contain random agents, make sure that the process of genetic modification is not creating a new random one agent that can harm human and animal health or the environment. Genetically modified organism contains no harmful agents, if random: 42.4.1. the modification process does not use viruses, Mycoplasma, bacteria, microscopic fungi, plant or animal cells, or the symbiont, which could cause harm;
42.4.2. the process of genetic modification using only cell cultures, the recipient or parental strain that does not contain incidental agents;
42.4.3. after genetic modification, the applicant can prove that the genetically modified organisms contain random agents that may harm human and animal health or the environment;
26.4. the genetically modified organisms is stable if: 42.5.1. map the genetically modified material, where the transfer is safe and it does not possess the ability to move or be transferred to more often than others the recipient or the donor organism's genes;
42.5.2. vector and the insert does not contain genes that encode resistance and may compromise the treatment process;
42.5.3. vector, which uses cloning (virus, kosmīd or any other of the virus vector derivative) is not lizogēn;
42.5.4. the process of genetic modification is not used in the sequence that has the sequence poksīrus or other functional properties of vectors;
26.5. the genetically modified organisms is not viable outside the restrictive measures. Genetically modified organisms harmful to the environment shall be assessed having regard to: 42.6.1. it could survive outside the usual conditions. If a genetically modified organism is able to exist outside of the restrictive measures, indicates genetically modified organism may spread and survival;
42.6.2. the development of genetically modified organism and effects into the food and feed chain;
42.6.3. environmental factors biotisko and abiotisko, in so far as they comply with certain genetically modified organism's ability to survive, to develop and compete in the environment;
42.6.4. the genetically modified organism, which is not viable outside the restrictive measures, the ability to transfer or to transfer genetic material to other organisms. 43. the genetically modified organisms intended for acquisition of the recipient and the donor organism models that could be considered appropriate safety criteria are the following: 43.1. strains derivatives that growth and survival depends on the addition of nutrients, which is not present in the human body or the environment;
43.2. eikariotisk cell and tissue culture systems if they comply with those rules established safety criteria. They do not contain harmful agents and not random in the vector to be mobilized;
43.3. the non-pathogenic in wild-type strains, which have special specific ecological niche. Such strains, putting out restrictive measures do not cause harmful effects on the environment or their impact is negligible. Such micro-organisms are well-studied genetic and molecular structure. 8. General principles for working with genetically modified organisms 44. Scientific institutions are obliged to comply with the following general principles when working with genetically modified organisms: 44.1. provide the lowest level of genetically modified organisms effects on jobs and environment; 44.2. take control of the presence of living organisms outside the restrictive measures;
27.5. to provide employees with appropriate protective clothing and personal protective equipment;
27.6. apply appropriate restrictive and precautionary measures to ensure the protection of human health, as well as to prevent the escape of genetically modified organisms out of the restrictive and security measures;
27.7. regularly control the technical equipment with the remaining contained use activities;
27.7. to provide regular training for employed labour protection requirements in work with genetically modified organisms;
44.7. develop internal labour protection instructions for working with genetically modified organisms;
27.8. deploy the work place safety signs that warn of possible biological risk;
27.9. fix up disinfection and shower room;
44.10. accurately enumerate and to record the actions that are made with genetically modified organisms;
44.11. impose a prohibition on eating, drinking, smoking, using cosmetics or keep food in place of work;
44.12. sides to provide automatic or automatic pipettes;
44.13. develop instructions, protocols or job descriptions contained use activities with genetically modified organisms;
44.14. provide a limited use area with appropriate disinfectants and disinfection for developing specific procedures for genetically modified organisms in local pollution prevention;
44.15. prevent laboratory equipment, instruments and materials premises. crossover 9. Information provision 45. food and veterinary service of the Ministry of agriculture and the European Commission with the following information:

45.1. once a year – a summary of the contained use activities that correspond to the third and fourth class of security, including the use of the limited steps, their purpose and information on possible risks to human and animal health or the environment;
45.2. every three years, a report on Council Directive 90/219/EEC on the contained use of genetically modified micro-organisms and application practice. 46. The food and veterinary service shall inform the Ministry of agriculture and the European Commission on the consequences of an emergency, indicating that rule 20.12. the information referred to in the subparagraph. 47. If after the emergency has created damage in another Member State of the European Union, the food and veterinary department after coordination with the Ministry of Foreign Affairs shall inform the European Commission of any emergency, announcing the rule. the information referred to in paragraph 20.12. 10. final question 48. provisions shall enter into force on December 1, 2008. Informative reference to European Union directives, the regulations include provisions resulting from: 1) the European Council 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;
2) of the Council of Europe on 23 April 1990 directive 90/219/EEC on the contained use of genetically modified micro-organisms. Prime Minister i. Godmanis farming Minister – the Minister of the environment annex r. vējonis Cabinet of 22 September 2008. Regulations No 784 Restrictive security measures and limited exploitation activities 1. minimum equipment requirements, doing work in the laboratory: no Specification limit degree PO box 1 2 3 4 1.1. laboratory complex izolācija1 optional optional optional optional 1.2. laboratory closings for disinfecting steam is optional optional optional optional 1.3. Surface that is resistant to water, acids, alkalis, solvents, disinfectants and cleaning products and is easy to clean (Workbench) mandatory mandatory optional) Workbench (Workbench, floor) mandatory (Workbench, floor, ceiling, walls) 1.4. entry in the laboratory through airlock2 optional optional optional optional 1.5. Low pressure against the environment is optional optional optional, except for the optional darbības3 Air flowing of 1.6 and scattering in a laboratory through a HEPA filters with highly effective preservatives optional optional optional using exhaust air filters HEPA4, except the mandatory darbības3 using HEPA5 filters inlet and exhaust air 1.7. Equipment 1.7.1. Laminar air flow boxing or special place for working with microorganisms is optional optional optional optional 1.7.2. Autoclave building complex building specially in the case of the piemērots6 Laboratory-a device which divides the work site 1.8. Work Organisation Limited release 1.8.1. work is not compulsory compulsory compulsory compulsory 1.8.2. the sign on the door that points to a biological hazards not mandatory mandatory mandatory mandatory 1.8.3. special measures for the control of distribution of aerosols is not necessarily required to reduce their distribution, to prevent their mandatory minimum distribution, to prevent their release 1.8.4. Optional Shower optional optional optional 1.8.5 protective clothing Suitable guard-clothing Suitable protective clothing (and optional safety shoes) suitable protective clothing for a complete change of clothing and footwear before entering the workplace and exit from the 1.8.6 gloves optional optional optional optional 1.8.7. effective disease vectors (e.g. , rodent and insect control optional) optional mandatory optional 1.9. Waste 1.9.1. Genetically modified organism inactivation source of hand wash sinks or drains, showers and other sources not required optional optional optional 1.9.2. Genetically modified organism inactivation in material and contaminated waste optional optional optional optional 1.10. other measures 1.10.1. Service laboratory equipment maintenance work order optional optional optional optional 1.10.2. Observation window or the other option in the laboratory for monitoring employees working After check After check After check optional notes. 1 laboratory complex isolation – the laboratory is separated from other areas in the same building or is located in a separate building. 2 air locks, isolated place, where getting into the laboratory. Air locks in the clean part of the modified organism to the limited use of the parts isolated with lockable door separated changing rooms or showers. 3 steps to prevent the spread of the infection through the air. 4-HEPA (high efficiency particulate air from particles especially effectively purified air) filters for air purification. 5 If using viruses, which are not retained by HEPA filters need to establish additional requirements for exhaust air. 6 with a reasonable operating conditions and a process that allows a safe material into the autoclave outside the lab, ensuring an adequate level of protection.

2. Additional requirements, doing work with genetically modified organisms in greenhouses (farms). The term "greenhouse" and "kennel" means a construction with walls, roof and floor, which is designed and used primarily for the production of plants in a limited and protected environment. Apply all of this annex 1 the requirements referred to in paragraph with the following additions: no Specification limit degree PO box 1 2 3 4 2.1. Building a greenhouse-separate 2.1.1 celtne1 optional optional optional optional equipment 2.2.1 2.2. entry via Airlock with double doors optional optional optional optional 2.2.2 effluent control optional optional to reduce the aizplūšanu2 required to prevent drain required to prevent the drain of the Labour Organization 2.3.1 2.3. Means to prevent unwanted species (such as arthropods or rodents specimens) from entering the required mandatory Mandatory mandatory 2.3.2. Isolation techniques to prevent the spread of genetically modified organisms in the life time of the transfer of the material from the greenhouse (nursery) to reduce the spread of the laboratory to reduce spread to prevent spread to prevent spread of the notes. 1 the greenhouse must be in a separate building, with a lockable door which closes with a waterproof roof, and equipment, to prevent water from entering the building. 2 If genetically modified organisms can occur through soil.

3. Additional requirements, doing work with animals, if you are using genetically modified organisms. Apply all of this annex 1 the requirements referred to in paragraph with the following additions: no Specification limit degree PO box 1 2 3 4 3.1 equipment 3.1.1. Animal housing izolācija1 optional optional optional optional Vivārij the nodalījumi2 3.1.2, separated by lockable door optional Compulsory compulsory compulsory Vivārij partition in 3.1.3. designed to facilitate their treatment (for example, waterproof and easily washable material cage) optional optional optional optional 3.1.4. Easy to wash the floor or the wall, optionally required (floor) required (floor and walls)
Required (floor and walls) 3.1.5. Animals are kept in suitable norobežojumo (e.g., cages, pens or tanks) by choice After choice After choice After choice 3.1.6. Filters before the insulator or isolated vieta3 optional optional optional optional notes. 1 animal housing-building or a separate area of the building which has the facilities and different rooms (such as changing rooms, showers, autoclave, food storage facilities). 2 Vivārij compartment, places where there vairojamo or animals used in experiments as well as sites that use simple surgical operations. 3 insulators – transparent boxing, where small animals kept in cages or outside them, great for keeping of animals used in isolated places.

4. General and safety requirements, other than those referred to in this annex 1, 2 and 3: no Specification limit degree PO box 1 2 3 4 4.1. Viable micro-organisms placed in the system, which ensures the separation of the process from the environment (closed system) optional mandatory optional optional 4.2. From the closed system eliminated the gas control is not necessarily required in order to reduce the spread of gas required to prevent the spread of the gas required to prevent the spread of 4.3 gas spray control at the time of sampling material replenishment during the closed system or transfer the materials to another closed system optional required, to reduce the spread of the material required to prevent the spread of the material required to prevent the spread of the material culture of unfractionated 4.4 fluid inactivation before ejected from the optional closed system mandatory, with reasonable means mandatory, with substantial funds required with reasonable means 4.5 isolation materials and equipment, which prevent or reduce the spread of genetically modified organisms is not a specific requirement to reduce spread to prevent spread

To prevent the spread of 4.6 control zone to receive the contents of the closed system does not limit the dispersal in the environment after selecting optional optional optional 4.7. control zone is concluded to be disinfected with steam not mandatory optional optional optional 4.8 4.8.1 access equipment through the airlock is optional optional optional optional 4.8.2. Easy to clean, water, acids, alkalis, solvents, disinfectants and cleaning products resistant surface Required (for machine tools If any) mandatory (machines, if any) mandatory (for machine tools, if any, floor) mandatory (machines, floor, ceiling, walls) 4.8.3. special funds to adequately ventilated area controlled and reduce air pollution by choice After choice After choice necessarily 4.8.4. Air pressure is reduced in the control zone to the surrounding environment is optional optional optional required 4.8.5. Control Zone air inflow and discharges through the HEPA filter optional optional required (exhaust air Optionally, inlet air) required (inlet and exhaust air) 4.9 organisation of work 4.9.1. Closed system located in the control area optional optional optional optional 4.9.2 approach only allowed certain personnel not required required required required 4.9.3. before leaving the control zone staff showering optional optional optional optional 4.9.4. Personnel should wear protective clothing required (working) required (working) required a complete makeover before entering the work station and exit from its waste 4.10.1 4.10. Genetically modified organism inactivation source from hand wash sinks, showers and other sources not required optional optional optional 4.10.2. Genetically modified organism inactivation in material and contaminated waste, including the closed process the exhaust before it entered the drain optional mandatory optional with reasonable means, with reasonable means mandatory, with reasonable means notes. 1. Scientific Authority, in consultation with the food and veterinary service may change the security measures, which corresponds to a given containment level or combine different grades according to the measures. 2. the tables "optional" means that the scientific authority may take these measures in certain cases according to the risk assessment.


Minister of agriculture, Minister for the environment r. vējonis

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